83 FR 32340 - Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 134 (July 12, 2018)
Page Range
32340-32522
FR Document
2018-14443
This proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. It also proposes updates to the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; proposes a rebasing of the HH market basket (which includes a decrease in the labor-related share); proposes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 hereinafter referred to as the ``BBA of 2018''; proposes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and proposes to define ``remote patient monitoring'' and recognize the cost associated as an allowable administrative cost. Additionally, it proposes case-mix methodology refinements to be implemented for home health services beginning on or after January 1, 2020, including a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the BBA of 2018; includes information on the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020, as required by section 50401 of the BBA of 2018; solicits comments regarding payment for home infusion therapy services for CY 2021 and subsequent years; proposes health and safety standards for home infusion therapy; and proposes an accreditation and oversight process for home infusion therapy suppliers. This rule proposes changes to the Home Health Value-Based Purchasing (HHVBP) Model to remove two OASIS-based measures, replace three OASIS-based measures with two new proposed composite measures, rescore the maximum number of improvement points, and reweight the measures in the applicable measures set. Also, the Home Health Quality Reporting Program provisions include a discussion of the Meaningful Measures Initiative and propose the removal of seven measures to further the priorities of this initiative. In addition, the HH QRP offers a discussion on social risk factors and an update on implementation efforts for certain provisions of the IMPACT Act. This proposed rule clarifies the regulatory text to note that not all OASIS data is required for the HH QRP. Finally, it would require that accrediting organization surveyors take CMS-provided training.
Federal Register, Volume 83 Issue 134 (Thursday, July 12, 2018)
[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Proposed Rules]
[Pages 32340-32522]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14443]
[[Page 32339]]
Vol. 83
Thursday,
No. 134
July 12, 2018
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 409, 424, 484, et al.
Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment
System Rate Update and CY 2020 Case-Mix Adjustment Methodology
Refinements; Home Health Value-Based Purchasing Model; Home Health
Quality Reporting Requirements; Home Infusion Therapy Requirements; and
Training Requirements for Surveyors of National Accrediting
Organizations; Proposed Rule
Federal Register / Vol. 83 , No. 134 / Thursday, July 12, 2018 /
Proposed Rules
[[Page 32340]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 409, 424, 484, 486, and 488
[CMS-1689-P]
RIN 0938-AT29
Medicare and Medicaid Programs; CY 2019 Home Health Prospective
Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology
Refinements; Home Health Value-Based Purchasing Model; Home Health
Quality Reporting Requirements; Home Infusion Therapy Requirements; and
Training Requirements for Surveyors of National Accrediting
Organizations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would update the home health prospective
payment system (HH PPS) payment rates, including the national,
standardized 60-day episode payment rates, the national per-visit
rates, and the non-routine medical supply (NRS) conversion factor,
effective for home health episodes of care ending on or after January
1, 2019. It also proposes updates to the HH PPS case-mix weights for
calendar year (CY) 2019 using the most current, complete data available
at the time of rulemaking; discusses our efforts to monitor the
potential impacts of the rebasing adjustments that were implemented in
CYs 2014 through 2017; proposes a rebasing of the HH market basket
(which includes a decrease in the labor-related share); proposes the
methodology used to determine rural add-on payments for CYs 2019
through 2022, as required by section 50208 of the Bipartisan Budget Act
of 2018 hereinafter referred to as the ``BBA of 2018''; proposes
regulations text changes regarding certifying and recertifying patient
eligibility for Medicare home health services; and proposes to define
``remote patient monitoring'' and recognize the cost associated as an
allowable administrative cost. Additionally, it proposes case-mix
methodology refinements to be implemented for home health services
beginning on or after January 1, 2020, including a change in the unit
of payment from 60-day episodes of care to 30-day periods of care, as
required by section 51001 of the BBA of 2018; includes information on
the implementation of temporary transitional payments for home infusion
therapy services for CYs 2019 and 2020, as required by section 50401 of
the BBA of 2018; solicits comments regarding payment for home infusion
therapy services for CY 2021 and subsequent years; proposes health and
safety standards for home infusion therapy; and proposes an
accreditation and oversight process for home infusion therapy
suppliers. This rule proposes changes to the Home Health Value-Based
Purchasing (HHVBP) Model to remove two OASIS-based measures, replace
three OASIS-based measures with two new proposed composite measures,
rescore the maximum number of improvement points, and reweight the
measures in the applicable measures set. Also, the Home Health Quality
Reporting Program provisions include a discussion of the Meaningful
Measures Initiative and propose the removal of seven measures to
further the priorities of this initiative. In addition, the HH QRP
offers a discussion on social risk factors and an update on
implementation efforts for certain provisions of the IMPACT Act. This
proposed rule clarifies the regulatory text to note that not all OASIS
data is required for the HH QRP. Finally, it would require that
accrediting organization surveyors take CMS-provided training.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on August 31, 2018.
ADDRESSES: In commenting, please refer to file code CMS-1689-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1689-P, P.O. Box 8013,
Baltimore, MD 21244-8013. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1689-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: For general information about the Home
Health Prospective Payment System (HH PPS), send your inquiry via email
to: [email protected].
For general information about home infusion payment, send your
inquiry via email to: [email protected].
For information about the Home Health Value-Based Purchasing
(HHVBP) Model, send your inquiry via email to:
[email protected].
For information about the Home Health Quality Reporting Program (HH
QRP) contact: Joan Proctor, (410) 786-0949.
For information about home infusion therapy health and safety
standards, contact: Sonia Swancy, (410) 786-8445 or CAPT Jacqueline
Leach, (410) 786-4282.
For information about health infusion therapy accreditation and
oversight, contact: Caroline Gallaher (410) 786-8705.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs and Benefits
D. Improving Patient Outcomes and Reducing Burden Through
Meaningful Measures
II. Background
A. Statutory Background
B. Current System for Payment of Home Health Services
C. Updates to the Home Health Prospective Payment System
D. Advancing Health Information Exchange
III. Payment Under the Home Health Prospective Payment System (HH
PPS)
A. Monitoring for Potential Impacts--Affordable Care Act
Rebasing Adjustments
B. Proposed CY 2019 HH PPS Case-Mix Weights
[[Page 32341]]
C. Proposed CY 2019 Home Health Payment Rate Update
D. Proposed Rural Add-On Payments for CYs 2019 Through 2022
E. Proposed Payments for High-Cost Outliers Under the HH PPS
F. Proposed Implementation of the Patient-Driven Groupings Model
(PDGM) for CY 2020
G. Proposed Regulations Text Changes Regarding Certifying and
Recertifying Patient Eligibility for Medicare Home Health Services
H. The Role of Remote Patient Monitoring Under the Medicare Home
Health Benefit
IV. Home Health Value-Based Purchasing (HHVBP) Model
A. Background
B. Quality Measures
C. Performance Scoring Methodology
D. Update on the Public Display of Total Performance Scores
V. Home Health Quality Reporting Program (HH QRP)
A. Background and Statutory Authority
B. General Considerations Used for the Selection of Quality
Measures for the HH QRP
C. Proposed Removal Factors for Previously Adopted HH QRP
Measures
D. Quality Measures Currently Adopted for the HH QRP
E. Proposed Removal of HH QRP Measures Beginning With the CY
2021 HH QRP
F. IMPACT Act Implementation Update
G. Form, Manner, and Timing of OASIS Data Submission
H. Proposed Policies Regarding Public Display for the HH QRP
I. HHCAHPS
VI. Medicare Coverage of Home Infusion Therapy Services
A. General Background
B. Proposed Health and Safety Standards for Home Infusion
Therapy
C. Payment for Home Infusion Therapy Services
D. Approval and Oversight of Accrediting Organizations for Home
Infusion Therapy (HIT) Suppliers
VII. Changes to the Accreditation Requirements for Certain Medicare
Certified Providers and Suppliers
A. Background
B. Proposed Changes to Certain Requirements for Medicare-
Certified Providers and Suppliers at Part 488
VIII. Requests for Information
A. Request for Information on Promoting Interoperability and
Electronic Healthcare Information Exchange Through Possible
Revisions to the CMS Patient Health and Safety Requirements for
Hospitals and Other Medicare- and Medicaid-Participating Providers
and Suppliers
B. Request for Information on Price Transparency: Improving
Beneficiary Access to Home Health Agency Charge Information
IX. Collection of Information Requirements
A. Wage Estimates
B. ICRs Regarding the OASIS
C. ICRs Regarding Home Infusion Therapy
D. ICRs Regarding the Approval and Oversight of Accrediting
Organizations for Home Infusion Therapy
X. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
D. Detailed Economic Analysis
E. Alternatives Considered
F. Accounting Statement and Tables
G. Regulatory Reform Analysis Under E.O. 13771
H. Conclusion
Regulation Text
I. Executive Summary
A. Purpose
1. Home Health Prospective Payment System (HH PPS)
This proposed rule would update the payment rates for home health
agencies (HHAs) for calendar year (CY) 2019, as required under section
1895(b) of the Social Security Act (the Act). This proposed rule would
also update the case-mix weights under section 1895(b)(4)(A)(i) and
(b)(4)(B) of the Act for CY 2019. For home health services beginning on
or after January 1, 2020, this rule proposes case-mix methodology
refinements, which eliminate the use of therapy thresholds for case-mix
adjustment purposes; and proposes to change the unit of payment from a
60-day episode of care to a 30-day period of care, as mandated by
section 51001 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123)
(hereinafter referred to as the ``BBA of 2018''). This proposed rule
also: Proposes the methodology used to determine rural add-on payments
for CYs 2019 through 2022, as required by section 50208 of the BBA of
2018; proposes regulations text changes regarding certifying and
recertifying patient eligibility for Medicare home health services
under sections 1814(a) and 1835(a) of the Act; and proposes to define
``remote patient monitoring'' under the Medicare home health benefit
and to include the costs of such monitoring as an allowable
administrative cost. Lastly, this rule proposes changes to the Home
Health Value Based Purchasing (HHVBP) Model under the authority of
section 1115A of the Act, and the Home Health Quality Reporting Program
(HH QRP) requirements under the authority of section 1895(b)(3)(B)(v)
of the Act.
2. Home Infusion Therapy Services
This proposed rule would establish a transitional payment for home
infusion therapy services for CYs 2019 and 2020, as required by section
50401 of the BBA of 2018. In addition, this rule proposes health and
safety standards for home infusion therapy, proposes an accreditation
and oversight process for qualified home infusion therapy suppliers,
and solicits comments regarding payment for the home infusion therapy
services benefit for CY 2021 and subsequent years, as required by
section 5012 of the 21st Century Cures Act (Pub. L. 114-255).
3. Safety Standards for Home Infusion Therapy Services
This proposed rule would establish health and safety standards for
qualified home infusion therapy suppliers as required by Section 5012
of the 21st Century Cures Act. These proposed standards would establish
a foundation for ensuring patient safety and quality care by
establishing requirements for the plan of care to be initiated and
updated by a physician; 7-day-a-week, 24-hour-a-day access to services
and remote monitoring; and patient education and training regarding
their home infusion therapy care.
B. Summary of the Major Provisions
1. Home Health Prospective Payment System (HH PPS)
Section III.A. of this rule discusses our efforts to monitor for
potential impacts due to the rebasing adjustments implemented in CY
2014 through CY 2017, as mandated by section 3131(a) of the Patient
Protection and Affordable Care Act of 2010 (Pub. L. 111-148, enacted
March 23, 2010) as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152, enacted March 30, 2010),
collectively referred to as the ``Affordable Care Act''. In the CY 2015
HH PPS final rule (79 FR 66072), we finalized our proposal to
recalibrate the case-mix weights every year with the most current and
complete data available at the time of rulemaking. In section III.B of
this rule, we are recalibrating the HH PPS case-mix weights, using the
most current cost and utilization data available, in a budget-neutral
manner. In section III.C., we propose to rebase the home health market
basket and update the payment rates under the HH PPS by the home health
payment update percentage of 2.1 percent (using the proposed 2016-based
Home Health Agency (HHA) market basket update of 2.8 percent, minus 0.7
percentage point for multifactor productivity) as required by section
1895(b)(3)(B)(vi)(I) of the Act. Also in section III.C. of this
proposed rule, we propose to decrease the labor-related share from 78.5
to 76.1 percent of total costs on account of the rebasing of the home
health market basket. Lastly, in
[[Page 32342]]
section III.C. of this rule, we propose to update the CY 2019 home
health wage index using FY 2015 hospital cost report data. In section
III.D. of this proposed rule, we are proposing a new methodology for
applying rural add-on payments for CYs 2019 through 2022, as required
by section 50208 of the BBA of 2018. In section III.E. of this rule, we
are proposing to reduce the fixed-dollar loss ratio from 0.55 to 0.51
for CY 2019 in order to increase outlier payments as a percentage of
total payments so that this percentage is closer to, but no more than,
2.5 percent.
In the CY 2018 HH PPS proposed rule, CMS proposed an alternative
case-mix model, called the Home Health Groupings Model (HHGM).
Ultimately the HHGM, including a proposed change in the unit of payment
from 60 days to 30 days, was not finalized in the CY 2018 HH PPS final
rule in order to allow CMS additional time to consider public comments
for potential refinements to the model and other alternative case-mix
models (82 FR 51676). In section III.F. of this proposed rule, we are
again proposing to implement case-mix methodology refinements and a
change in the unit of payment from a 60-day episode of care to a 30-day
period of care; however, these changes would be effective January 1,
2020 and would be implemented in a budget neutral manner, as required
by section 51001 of the BBA of 2018. Since the proposed case-mix
methodology refinements represent a more patient-driven approach to
payment we are renaming the proposed case-mix adjustment methodology
refinements, formerly known as the Home Health Groupings Model or
``HHGM'', as the ``Patient-Driven Groupings Model'' or PDGM. The
proposed PDGM relies more heavily on clinical characteristics and other
patient information to place patients into meaningful payment
categories and eliminates the use of therapy service thresholds, as
required by section 51001(a)(3) of the BBA of 2018, that are currently
used to case-mix adjust payments under the HH PPS. There is also a
proposal regarding how CMS would determine whether 30-day periods of
care are subject to a Low-Utilization Payment Adjustment (LUPA). The
LUPA add-on policy, the partial episode payment adjustment policy, and
the methodology used to calculate payments for high-cost outliers would
remain unchanged except for occurring on a 30-day basis rather than a
60-day basis.
In section III.G. of this proposed rule, we are proposing
regulation text changes at 42 CFR 424.22(b)(2) to eliminate the
requirement that the certifying physician must estimate how much longer
skilled services will be needed as part of the recertification
statement. In addition, in section III.G of this rule, consistent with
section 51002 of the BBA of 2018, we are proposing to align the
regulations text at 42 CFR 424.22(c) with current subregulatory
guidance to allow medical record documentation from the HHA to be used
to support the basis for certification and/or recertification of home
health eligibility, if certain requirements are met.
In section III.H. of this proposed rule, we propose to define
``remote patient monitoring'' under the Medicare home health benefit as
the collection of physiologic data (for example, ECG, blood pressure,
glucose monitoring) digitally stored and/or transmitted by the patient
and/or caregiver to the HHA. Additionally in this section of the rule,
we propose changes to the regulations at 42 CFR 409.46 to include costs
of remote patient monitoring as allowable administrative costs.
2. Home Health Value Based Purchasing
In section IV of this proposed rule, we are proposing changes to
the Home Health Value Based Purchasing (HHVBP) Model implemented
January 1, 2016. We are proposing, beginning with performance year (PY)
4, to: Remove two Outcome and Assessment Information Set (OASIS) based
measures, Influenza Immunization Received for Current Flu Season and
Pneumococcal Polysaccharide Vaccine Ever Received, from the set of
applicable measures; replace three OASIS-based measures (Improvement in
Ambulation-Locomotion, Improvement in Bed Transferring, and Improvement
in Bathing) with two proposed composite measures on total normalized
composite change in self-care and mobility; change how we calculate the
Total Performance Scores by changing the weighting methodology for the
OASIS-based, claims-based, and HHCAHPS measures; and change the scoring
methodology by reducing the maximum amount of improvement points an HHA
could earn, from 10 points to 9 points. While we are not making a
specific proposal at this time, we are also providing an update on the
progress towards developing public reporting of performance under the
HHVBP Model and seeking comment on what information should be made
publicly available.
3. Home Health Quality Reporting Program
In section V. of this proposed rule, we are proposing to update our
policy for removing previously adopted Home Health (HH) Quality
Reporting Program (QRP) measures and to adopt eight measure removal
factors to align with other QRPs, to remove seven measures beginning
with the CY 2021 HH QRP, and to update our regulations to clarify that
not all OASIS data is required for the HH QRP. We are also providing an
update on the implementation of certain provisions of the IMPACT Act,
and a discussion of accounting for social risk factors in the HH QRP.
Finally, we are proposing to increase the number of years of data used
to calculate the Medicare Spending per Beneficiary measure for purposes
of display from 1 year to 2 years.
4. Home Infusion Therapy
In section VI.A. of this proposed rule, we discuss general
background of home infusion therapy services and how that will relate
to the implementation of the new home infusion benefit. In section
VI.B. of this proposed rule, we are proposing to add a new subpart I
under the regulations at 42 CFR part 486 to incorporate health and
safety requirements for home infusion therapy suppliers. The proposed
regulations would provide a framework for CMS to approve home infusion
therapy accreditation organizations. Proposed subpart I would include
General Provisions (Scope and Purpose, and Definitions) and Standards
for Home Infusion Therapy (Plan of Care and Required Services). In
section VI.C. of this proposed rule, we include information on
temporary transitional payments for home infusion therapy services for
CYs 2019 and 2020 as mandated by section 50401 of the BBA of 2018, and
solicits comments on the proposed regulatory definition of ``Infusion
Drug Administration Calendar Day''. Also in section VI.C. of this
proposed rule, we solicit comments regarding payment for home infusion
therapy services for CY 2021 and subsequent years as required by
section 5012(d) of the 21st Century Cures Act.
In section VI.D. of this proposed rule, we discuss the requirements
set forth in section 1861(iii)(3)(D)(III) of the Act, which mandates
that suppliers of home infusion therapy receive accreditation from a
CMS-approved Accrediting Organization (AO) in order to receive Medicare
payment. The Secretary must designate AOs to accredit suppliers
furnishing Home Infusion therapy (HIT) not later than January 1, 2021.
Qualified
[[Page 32343]]
HIT suppliers are required to receive accreditation before receiving
Medicare payment for services provided to Medicare beneficiaries.
At this time, no regulations exist to address the following
elements of CMS' approval and oversight of the AOs that accredit
suppliers of Home Infusion Therapy: (1) The required components to be
included in a Home Infusion Therapy AO's initial or renewal
accreditation program application; (2) regulations related to CMS'
review and approval of the Home Infusion Therapy AOs application for
approval of its accreditation program; and (3) the ongoing monitoring
and oversight of CMS-approved Home Infusion Therapy AOs. Therefore in
this rule, we propose to establish a set of regulations that will
govern the CMS approval and oversight process for all HIT AOs.
We also propose to modify the regulations for oversight for AOs
that accredit any Medicare-certified providers and suppliers at 42 CFR
488.5 by adding a requirement that the AOs must include a statement
with their application acknowledging that all AO surveyors are required
to complete the relevant program specific CMS online trainings
initially, and thereafter, consistent with requirements established by
CMS for state and federal surveyors. We would also add another
requirement at Sec. 488.5 that would require the AOs for Medicare
certified providers and suppliers to provide a written statement with
their application stating that if a fully accredited and facility
deemed to be in good-standing provides written notification that they
wish to voluntarily withdraw from the AO's CMS-approved accreditation
program, the AO must continue the facility's current accreditation
until the effective date of withdrawal identified by the facility or
the expiration date of the term of accreditation, whichever comes
first.
C. Summary of Costs, Transfers, and Benefits
Table 1--Summary of Costs, Transfers, and Benefits
----------------------------------------------------------------------------------------------------------------
Provision description Costs and cost savings Transfers Benefits
----------------------------------------------------------------------------------------------------------------
CY 2019 HH PPS Payment Rate Update... ....................... The overall economic To ensure home health
impact of the HH PPS payments are
payment rate update is consistent with
an estimated $400 statutory payment
million (2.1 percent) authority for CY 2019.
in increased payments
to HHAs in CY 2019.
CY 2019 Temporary Transitional ....................... The overall economic To ensure temporary
Payments for Home Infusion Therapy impact of the transitional payments
Services. temporary transitional for home infusion
payment for home therapy are consistent
infusion therapy with statutory
services is an authority for CY 2019.
estimated $60 million
in increased payments
to home infusion
therapy suppliers in
CY 2019.
CY 2019 HHVBP Model.................. ....................... The overall economic
impact of the HHVBP
Model provision for CY
2018 through 2022 is
an estimated $378
million in total
savings from a
reduction in
unnecessary
hospitalizations and
SNF usage as a result
of greater quality
improvements in the HH
industry (none of
which is attributable
to the changes
proposed in this
proposed rule). As for
payments to HHAs,
there are no aggregate
increases or decreases
expected to be applied
to the HHAs competing
in the model.
CY 2020 OASIS Changes................ The overall economic ....................... A reduction in burden
impact of the HH QRP to HHAs of
and the case-mix approximately 73 hours
adjustment methodology annually for a savings
changes is annual of approximately
savings to HHAs of an $5,150 annually per
estimated $60 million. HHA.
CY 2020 Case-Mix Adjustment ....................... The overall economic To ensure home health
Methodology Changes, Including a impact of the proposed payments are
Change in the Unit of Service from case-mix adjustment consistent with
60 to 30 days. methodology changes, statutory payment
including a change in authority for CY 2020.
the unit of service
from 60 to 30 days,
for CY 2020 results in
no estimated dollar
impact to HHAs, as
section 51001(a) of
the BBA of 2018
requires such change
to be implemented in a
budget-neutral manner.
[[Page 32344]]
Accreditation for Home Infusion ....................... The cost related to an
Therapy suppliers. AO obtaining CMS
approval of a home
infusion therapy
accreditation program
is estimated to be
$8,014.50 per each AO,
for AOs that have
previously submitted
an accreditation
application to CMS.
The cost across the
potential 6 home
infusion therapy AOs
would be $48,087.
The cost related to
each home infusion
therapy AO for
obtaining CMS approval
of a home infusion
therapy accreditation
program is estimated
to be $12,453 per each
AO, for AOs that have
not previously
submitted an
accreditation
application to CMS.
The cost across the
potential 6 home
infusion therapy AOs
would be $74,718.
We further estimate
that each home
infusion therapy AO
would incur an
estimated cost burden
in the amount of
$23,258 for compliance
with the proposed home
infusion therapy AO
approval and oversight
regulations at Sec.
Sec. 488.1010
through 488.1050
(including the filing
of an application).
The cost across the 6
potential home
infusion therapy AOs
would be $139,548.
----------------------------------------------------------------------------------------------------------------
D. Improving Patient Outcomes and Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing regulatory burden are high
priorities for us. To reduce the regulatory burden on the healthcare
industry, lower health care costs, and enhance patient care, in October
2017, we launched the Meaningful Measures Initiative.\1\ This
initiative is one component of our agency-wide Patients Over Paperwork
Initiative \2\ which is aimed at evaluating and streamlining
regulations with a goal to reduce unnecessary cost and burden, increase
efficiencies, and improve beneficiary experience. The Meaningful
Measures Initiative is aimed at identifying the highest priority areas
for quality measurement and quality improvement in order to assess the
core quality of care issues that are most vital to advancing our work
to improve patient outcomes. The Meaningful Measures Initiative
represents a new approach to quality measures that fosters operational
efficiencies, and will reduce costs including, the collection and
reporting burden while producing quality measurement that is more
focused on meaningful outcomes.
---------------------------------------------------------------------------
\1\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\2\ See Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017 https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
---------------------------------------------------------------------------
The Meaningful Measures Framework has the following objectives:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures where
possible, such as electronic clinical quality measures);
Provide significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
In order to achieve these objectives, we have identified 19
Meaningful Measures areas and mapped them to six overarching quality
priorities as shown in Table 2:
Table 2--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
Quality priority Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm Healthcare-Associated
Caused in the Delivery of Care. Infections.
Preventable Healthcare Harm.
[[Page 32345]]
Strengthen Person and Family Engagement Care is Personalized and
as Partners in Their Care. Aligned with Patient's Goals.
End of Life Care according to
Preferences.
Patient's Experience of Care.
Patient Reported Functional
Outcomes.
Promote Effective Communication and Medication Management.
Coordination of Care. Admissions and Readmissions to
Hospitals.
Transfer of Health Information
and Interoperability.
Promote Effective Prevention and Preventive Care.
Treatment of Chronic Disease. Management of Chronic
Conditions.
Prevention, Treatment, and
Management of Mental Health.
Prevention and Treatment of
Opioid and Substance Use
Disorders.
Risk Adjusted Mortality.
Work with Communities to Promote Best Equity of Care.
Practices of Healthy Living. Community Engagement.
Make Care Affordable................... Appropriate Use of Healthcare.
Patient-focused Episode of
Care.
Risk Adjusted Total Cost of
Care.
------------------------------------------------------------------------
By including Meaningful Measures in our programs, we believe that
we can also address the following cross-cutting measure criteria:
Eliminating disparities;
Tracking measurable outcomes and impact;
Safeguarding public health;
Achieving cost savings;
Improving access for rural communities; and
Reducing burden.
We believe that the Meaningful Measures Initiative will improve
outcomes for patients, their families, and health care providers while
reducing burden and costs for clinicians and providers and promoting
operational efficiencies.
II. Background
A. Statutory Background
1. Home Health Prospective Payment System
a. Background
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted
August 5, 1997), significantly changed the way Medicare pays for
Medicare home health services. Section 4603 of the BBA mandated the
development of the HH PPS. Until the implementation of the HH PPS on
October 1, 2000, HHAs received payment under a retrospective
reimbursement system.
Section 4603(a) of the BBA mandated the development of a HH PPS for
all Medicare-covered home health services provided under a plan of care
(POC) that were paid on a reasonable cost basis by adding section 1895
of the Act, entitled ``Prospective Payment For Home Health Services.''
Section 1895(b)(1) of the Act requires the Secretary to establish a HH
PPS for all costs of home health services paid under Medicare. Section
1895(b)(2) of the Act requires that, in defining a prospective payment
amount, the Secretary will consider an appropriate unit of service and
the number, type, and duration of visits provided within that unit,
potential changes in the mix of services provided within that unit and
their cost, and a general system design that provides for continued
access to quality services.
Section 1895(b)(3)(A) of the Act requires the following: (1) The
computation of a standard prospective payment amount that includes all
costs for HH services covered and paid for on a reasonable cost basis,
and that such amounts be initially based on the most recent audited
cost report data available to the Secretary (as of the effective date
of the 2000 final rule), and (2) the standardized prospective payment
amount be adjusted to account for the effects of case-mix and wage
levels among HHAs.
Section 1895(b)(3)(B) of the Act requires the standard prospective
payment amounts be annually updated by the home health applicable
percentage increase. Section 1895(b)(4) of the Act governs the payment
computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act
require the standard prospective payment amount to be adjusted for
case-mix and geographic differences in wage levels. Section
1895(b)(4)(B) of the Act requires the establishment of an appropriate
case-mix change adjustment factor for significant variation in costs
among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the
establishment of wage adjustment factors that reflect the relative
level of wages, and wage-related costs applicable to home health
services furnished in a geographic area compared to the applicable
national average level. Under section 1895(b)(4)(C) of the Act, the
wage-adjustment factors used by the Secretary may be the factors used
under section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to
make additions or adjustments to the payment amount otherwise paid in
the case of outliers due to unusual variations in the type or amount of
medically necessary care. Section 3131(b)(2) of the Affordable Care Act
revised section 1895(b)(5) of the Act so that total outlier payments in
a given year would not exceed 2.5 percent of total payments projected
or estimated. The provision also made permanent a 10 percent agency-
level outlier payment cap.
In accordance with the statute, as amended by the BBA, we published
a final rule in the July 3, 2000 Federal Register (65 FR 41128) to
implement the HH PPS legislation. The July 2000 final rule established
requirements for the new HH PPS for home health services as required by
section 4603 of the BBA, as subsequently amended by section 5101 of the
Omnibus Consolidated and Emergency Supplemental Appropriations Act for
Fiscal Year 1999 (OCESAA), (Pub. L. 105-277, enacted October 21, 1998);
and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP
Balanced Budget Refinement Act of 1999, (BBRA) (Pub. L. 106-113,
enacted November 29, 1999). The requirements include the implementation
of a HH PPS for home health services, consolidated billing
requirements, and a number of other related changes. The HH PPS
described in that rule replaced the retrospective reasonable cost-based
system that was used by Medicare for the payment of home health
services under Part A and Part B. For a complete and full
[[Page 32346]]
description of the HH PPS as required by the BBA, see the July 2000 HH
PPS final rule (65 FR 41128 through 41214).
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L.
109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v)
to the Act, requiring HHAs to submit data for purposes of measuring
health care quality, and linking the quality data submission to the
annual applicable payment percentage increase. This data submission
requirement is applicable for CY 2007 and each subsequent year. If an
HHA does not submit quality data, the home health market basket
percentage increase is reduced by 2 percentage points. In the November
9, 2006 Federal Register (71 FR 65884, 65935), we published a final
rule to implement the pay-for-reporting requirement of the DRA, which
was codified at Sec. 484.225(h) and (i) in accordance with the
statute. The pay-for-reporting requirement was implemented on January
1, 2007.
The Affordable Care Act made additional changes to the HH PPS. One
of the changes in section 3131 of the Affordable Care Act is the
amendment to section 421(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173,
enacted on December 8, 2003) as amended by section 5201(b) of the DRA.
Section 421(a) of the MMA, as amended by section 3131 of the Affordable
Care Act, requires that the Secretary increase, by 3 percent, the
payment amount otherwise made under section 1895 of the Act, for HH
services furnished in a rural area (as defined in section 1886(d)(2)(D)
of the Act) with respect to episodes and visits ending on or after
April 1, 2010, and before January 1, 2016.
Section 210 of the Medicare Access and CHIP Reauthorization Act of
2015 (Pub. L. 114-10) (MACRA) amended section 421(a) of the MMA to
extend the 3 percent rural add-on payment for home health services
provided in a rural area (as defined in section 1886(d)(2)(D) of the
Act) through January 1, 2018. In addition, section 411(d) of MACRA
amended section 1895(b)(3)(B) of the Act such that CY 2018 home health
payments be updated by a 1 percent market basket increase. This year,
section 50208(a)(1) of the BBA of 2018 again extended the rural add-on
through the end of 2018. In addition, this section of the BBA of 2018
made some important changes to the rural add-on for CYs 2019 through
2022, to be discussed below.
b. Current System for Payment of Home Health Services
Generally, Medicare currently makes payment under the HH PPS on the
basis of a national, standardized 60-day episode payment rate that is
adjusted for the applicable case-mix and wage index. The national,
standardized 60-day episode rate includes the six home health
disciplines (skilled nursing, home health aide, physical therapy,
speech-language pathology, occupational therapy, and medical social
services). Payment for non-routine supplies (NRS) is not part of the
national, standardized 60-day episode rate, but is computed by
multiplying the relative weight for a particular NRS severity level by
the NRS conversion factor. Payment for durable medical equipment
covered under the HH benefit is made outside the HH PPS payment system.
To adjust for case-mix, the HH PPS uses a 153-category case-mix
classification system to assign patients to a home health resource
group (HHRG). The clinical severity level, functional severity level,
and service utilization are computed from responses to selected data
elements in the OASIS assessment instrument and are used to place the
patient in a particular HHRG. Each HHRG has an associated case-mix
weight which is used in calculating the payment for an episode. Therapy
service use is measured by the number of therapy visits provided during
the episode and can be categorized into nine visit level categories (or
thresholds): 0 to 5; 6; 7 to 9; 10; 11 to 13; 14 to 15; 16 to 17; 18 to
19; and 20 or more visits.
For episodes with four or fewer visits, Medicare pays national per-
visit rates based on the discipline(s) providing the services. An
episode consisting of four or fewer visits within a 60-day period
receives what is referred to as a low-utilization payment adjustment
(LUPA). Medicare also adjusts the national standardized 60-day episode
payment rate for certain intervening events that are subject to a
partial episode payment adjustment (PEP adjustment). For certain cases
that exceed a specific cost threshold, an outlier adjustment may also
be available.
c. Updates to the Home Health Prospective Payment System
As required by section 1895(b)(3)(B) of the Act, we have
historically updated the HH PPS rates annually in the Federal Register.
The August 29, 2007 final rule with comment period set forth an update
to the 60-day national episode rates and the national per-visit rates
under the HH PPS for CY 2008. The CY 2008 HH PPS final rule included an
analysis performed on CY 2005 home health claims data, which indicated
a 12.78 percent increase in the observed case-mix since 2000. Case-mix
represents the variations in conditions of the patient population
served by the HHAs. Subsequently, a more detailed analysis was
performed on the 2005 case-mix data to evaluate if any portion of the
12.78 percent increase was associated with a change in the actual
clinical condition of home health patients. We identified 8.03 percent
of the total case-mix change as real, and therefore, decreased the
12.78 percent of total case-mix change by 8.03 percent to get a final
nominal case-mix increase measure of 11.75 percent (0.1278 * (1-0.0803)
= 0.1175).
To account for the changes in case-mix that were not related to an
underlying change in patient health status, we implemented a reduction,
over 4 years, to the national, standardized 60-day episode payment
rates. That reduction was to be 2.75 percent per year for 3 years
beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011.
In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses
of case-mix change and finalized a reduction of 3.79 percent, instead
of 2.71 percent, for CY 2011 and deferred finalizing a payment
reduction for CY 2012 until further study of the case-mix change data
and methodology was completed.
In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-
day national episode rates and the national per-visit rates. In
addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528),
our analysis indicated that there was a 22.59 percent increase in
overall case-mix from 2000 to 2009 and that only 15.76 percent of that
overall observed case-mix percentage increase was due to real case-mix
change. As a result of our analysis, we identified a 19.03 percent
nominal increase in case-mix. At that time, to fully account for the
19.03 percent nominal case-mix growth identified from 2000 to 2009, we
finalized a 3.79 percent payment reduction in CY 2012 and a 1.32
percent payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77 FR 67078), we implemented the
1.32 percent reduction to the payment rates for CY 2013 finalized the
previous year, to account for nominal case-mix growth from 2000 through
2010. When taking into account the total measure of case-mix change
(23.90 percent) and the 15.97 percent of total case-mix change
estimated as real from 2000 to 2010, we obtained a final nominal case-
mix change measure of 20.08 percent from
[[Page 32347]]
2000 to 2010 (0.2390 * (1 - 0.1597) = 0.2008). To fully account for the
remainder of the 20.08 percent increase in nominal case-mix beyond that
which was accounted for in previous payment reductions, we estimated
that the percentage reduction to the national, standardized 60-day
episode rates for nominal case-mix change would be 2.18 percent.
Although we considered proposing a 2.18 percent reduction to account
for the remaining increase in measured nominal case-mix, we finalized
the 1.32 percent payment reduction to the national, standardized 60-day
episode rates in the CY 2012 HH PPS final rule (76 FR 68532). Section
3131(a) of the Affordable Care Act added new section 1895(b)(3)(A)(iii)
to the Act, which required that, beginning in CY 2014, we apply an
adjustment to the national, standardized 60-day episode rate and other
amounts that reflect factors such as changes in the number of visits in
an episode, the mix of services in an episode, the level of intensity
of services in an episode, the average cost of providing care per
episode, and other relevant factors. Additionally, we were required to
phase in any adjustment over a 4-year period in equal increments, not
to exceed 3.5 percent of the payment amount (or amounts) as of the date
of enactment of the Affordable Care Act in 2010, and fully implement
the rebasing adjustments by CY 2017. Therefore, in the CY 2014 HH PPS
final rule (78 FR 72256) for each year, CY 2014 through CY 2017, we
finalized a fixed-dollar reduction to the national, standardized 60-day
episode payment rate of $80.95 per year, increases to the national per-
visit payment rates per year, and a decrease to the NRS conversion
factor of 2.82 percent per year. We also finalized three separate LUPA
add-on factors for skilled nursing, physical therapy, and speech-
language pathology and removed 170 diagnosis codes from assignment to
diagnosis groups in the HH PPS Grouper. In the CY 2015 HH PPS final
rule (79 FR 66032), we implemented the second year of the 4-year phase-
in of the rebasing adjustments to the HH PPS payment rates and made
changes to the HH PPS case-mix weights. In addition, we simplified the
face-to-face encounter regulatory requirements and the therapy
reassessment timeframes.
In the CY 2016 HH PPS final rule (80 FR 68624), we implemented the
third year of the 4-year phase-in of the rebasing adjustments to the
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as discussed previously). In
the CY 2016 HH PPS final rule, we also recalibrated the HH PPS case-mix
weights, using the most current cost and utilization data available, in
a budget-neutral manner and finalized reductions to the national,
standardized 60-day episode payment rate in CY 2016, CY 2017, and CY
2018 of 0.97 percent in each year to account for estimated case-mix
growth unrelated to increases in patient acuity (that is, nominal case-
mix growth) between CY 2012 and CY 2014. Finally, section 421(a) of the
MMA, as amended by section 210 of the MACRA, extended the payment
increase of 3 percent for HH services provided in rural areas (as
defined in section 1886(d)(2)(D) of the Act) to episodes or visits
ending before January 1, 2018.
In the CY 2017 HH PPS final rule (81 FR 76702), we implemented the
last year of the 4-year phase-in of the rebasing adjustments to the
national, standardized 60-day episode payment amount, the national per-
visit rates and the NRS conversion factor (as outlined previously). We
also finalized changes to the methodology used to calculate outlier
payments under the authority of section 1895(b)(5) of the Act. Lastly,
in accordance with section 1834(s) of the Act, as added by section
504(a) of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113,
enacted December 18, 2015), we implemented changes in payment for
furnishing Negative Pressure Wound Therapy (NPWT) using a disposable
device for patients under a home health plan of care for which payment
would otherwise be made under section 1895(b) of the Act.
2. Home Infusion Therapy
Section 5012 of the 21st Century Cures Act (``the Cures Act'')
(Pub. L. 114-255), which amended sections 1861(s)(2) and 1861(iii) of
the Act, established a new Medicare home infusion therapy benefit. The
Medicare home infusion therapy benefit covers the professional services
including nursing services furnished in accordance with the plan of
care, patient training and education (not otherwise covered under the
durable medical equipment benefit), remote monitoring, and monitoring
services for the provision of home infusion therapy and home infusion
drugs furnished by a qualified home infusion therapy supplier. This
benefit will ensure consistency in coverage for home infusion benefits
for all Medicare beneficiaries. Section 50401 of the BBA of 2018
amended section 1834(u) of the Act by adding a new paragraph (7) that
establishes a home infusion therapy services temporary transitional
payment for eligible home infusion suppliers for certain items and
services furnished in coordination with the furnishing of transitional
home infusion drugs beginning January 1, 2019. This temporary payment
covers the cost of the same items and services, as defined in section
1861(iii)(2)(A) and (B) of the Act, related to the administration of
home infusion drugs. The temporary transitional payment would begin on
January 1, 2019 and end the day before the full implementation of the
home infusion therapy benefit on January 1, 2021, as required by
section 5012 of the 21st Century Cures Act.
Home infusion therapy is a treatment option for patients with a
wide range of acute and chronic conditions, ranging from bacterial
infections to more complex conditions such as late-stage heart failure
and immune deficiencies. Home infusion therapy affords a patient
independence and better quality of life, because it is provided in the
comfort of the patient's home at a time that best fits his or her
needs. This is significant, because generally patients can return to
their daily activities after they receive their infusion treatments
and, in many cases, they can continue their activities while receiving
their treatments. In addition, home infusion therapy can provide
improved safety and better outcomes. The home has been shown to be a
safe setting for patients to receive infusion therapy.\3\ Additionally,
patients receiving treatment outside of the hospital setting may be at
lower risk of hospital-acquired infections, which can be more difficult
to treat because of multi-drug resistance than those that are
community-acquired. This is particularly important for vulnerable
patients such as those who are immunocompromised, as hospital-acquired
infections are increasingly caused by antibiotic-resistant pathogens.
---------------------------------------------------------------------------
\3\ Bhole, M.V., Burton, J., & Chapel, H.M., (2008). Self-
infusion programs for immunoglobulin replacement at home:
Feasibility, safety and efficacy. Immunology and Allergy Clinics of
North America, 28(4), 821-832. doi:10.1016/j.iac.2008.06.005.
Souayah, N., Hasan, A., Khan, H., et al. (2011). The safety
profile of home infusion of intravenous immunoglobulin in patients
with neuroimmunologic disorders. Journal of Clinical Neuromuscular
Disease, 12(supp 4), S1-10. doi: 10.1097/CND.0b013e3182212589.
---------------------------------------------------------------------------
Infusion therapy typically means that a drug is administered
intravenously, but the term may also refer to situations where drugs
are provided through other non-oral routes, such as intramuscular
injections and epidural routes (into the membranes surrounding the
spinal cord). Diseases that may require infusion therapy include
infections that are unresponsive to oral antibiotics, cancer and
cancer-related pain,
[[Page 32348]]
dehydration, and gastrointestinal diseases or disorders which prevent
normal functioning of the gastrointestinal system. Other conditions
treated with specialty infusion therapies may include some forms of
cancers, congestive heart failure, Crohn's Disease, hemophilia,
hepatitis, immune deficiencies, multiple sclerosis and rheumatoid
arthritis. Infusion therapy originates with a prescription order from a
physician or another qualified prescriber who is overseeing the care of
the patient. The prescription order is sent to a home infusion therapy
supplier, which is a state-licensed pharmacy, physician, or other
provider of services or suppliers licensed by the state.
A 2010 Government Accountability Office (GAO) report (10-426) found
that most health insurers rely on credentialing, accreditation, or both
to help ensure that plan members receive quality home infusion services
from their network suppliers.\4\ Home infusion AOs conduct on-site
surveys to evaluate all components of the service, including medical
equipment, nursing, and pharmacy. Accreditation standards can include
such requirements as the CMS Conditions of Participation for home
health services, other Federal government regulations, and industry
best practices. All of the accreditation standards evaluate a range of
provider competencies, such as having a complete plan of care, response
to adverse events, and implementation of a quality improvement plan.
---------------------------------------------------------------------------
\4\ https://www.gao.gov/assets/310/305261.pdf.
---------------------------------------------------------------------------
Sections 1861(iii)(3)(D)(III) and 1834(u)(5) of the Act, as amended
by section 5012 of the Cures Act requires that, in order to participate
in Medicare, home infusion therapy suppliers must select a CMS-approved
AO and undergo an accreditation review process to demonstrate that the
home infusion therapy program meets the accreditation organization's
standards. Section 1861(iii) of the Act, as amended by section 5012 of
the Cures Act, sets forth standards in three areas: (1) Ensuring that
all patients have a plan of care established and updated by a physician
that sets out the care and prescribed infusion therapy necessary to
meet the patient-specific needs, (2) having procedures to ensure that
remote monitoring services associated with administering infusion drugs
in a patient's home are provided, and (3) having procedures to ensure
that patients receive education and training on the effective use of
medications and equipment in the home.
D. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care. The Office of the
National Coordinator for Health Information Technology (ONC) and CMS
work collaboratively to advance interoperability across settings of
care, including post-acute care.
The Improving Medicare Post-Acute Care Transformation Act of 2014
(Pub. L. 113-185) (IMPACT Act) requires assessment data to be
standardized and interoperable to allow for exchange of the data among
post-acute providers and other providers. To further interoperability
in post-acute care, CMS is developing a Data Element Library to serve
as a publically available centralized, authoritative resource for
standardized data elements and their associated mappings to health IT
standards. These interoperable data elements can reduce provider burden
by allowing the use and reuse of healthcare data, support provider
exchange of electronic health information for care coordination,
person-centered care, and support real-time, data driven, clinical
decision making. Once available, standards in the Data Element Library
can be referenced on the CMS website and in the ONC Interoperability
Standards Advisory (ISA).
The 2018 Interoperability Standards Advisory (ISA) is available at:
https://www.healthit.gov/standards-advisory.
Most recently, the 21st Century Cures Act (Pub. L. 114-255),
enacted in 2016, requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. Specifically,
Congress directed ONC to ``develop or support a trusted exchange
framework, including a common agreement among health information
networks nationally.'' This framework (https://beta.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement)
outlines a common set of principles for trusted exchange and minimum
terms and conditions for trusted exchange in order to enable
interoperability across disparate health information networks. In
another important provision, Congress defined ``information blocking''
as practices likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information,
and established new authority for HHS to discourage these practices. We
invite providers to learn more about these important developments and
how they are likely to affect HHAs.
III. Proposed Provisions for Payment Under the Home Health Prospective
Payment System (HH PPS)
A. Monitoring for Potential Impacts--Affordable Care Act Rebasing
Adjustments
1. Analysis of FY 2016 HHA Cost Report Data
As part of our efforts in monitoring the potential impacts of the
rebasing adjustments finalized in the CY 2014 HH PPS final rule (78 FR
72293), we continue to update our analysis of home health cost report
and claims data. Previous years' cost report and claims data analyses
and results can be found in the CY 2018 HH PPS proposed rule (82 FR
35277-35278). For this proposed rule, we analyzed the 2016 HHA cost
report data (the most recent, complete data available at the time of
this proposed rule) and 2016 HHA claims data to obtain the average
number of visits per episode that match to the year of cost report data
analyzed. To determine the 2016 average cost per visit per discipline,
we applied the same trimming methodology outlined in the CY 2014 HH PPS
proposed rule (78 FR 40284) and weighted the costs per visit from the
2016 cost reports by size, facility type, and urban/rural location so
the costs per visit were nationally representative according to 2016
claims data. The 2016 average number of visits was taken from 2016
claims data. We estimated the cost of a 60-day episode in CY 2016 to be
$2,538.54 using 2016 cost report data (Table 2). However, the national,
standardized 60-day episode payment amount in CY 2016 was $2,965.12.
The difference between the 60-day episode payment rate and average cost
per episode of care for CY 2016 was 16.8 percent.
[[Page 32349]]
Table 2--2016 Estimated Cost per Episode
----------------------------------------------------------------------------------------------------------------
2016 Average 2016 Average 2016 Average 2016 Average
Discipline costs per NRS costs per cost + NRS per number of 2016 60-Day
visit visit visit visits episode costs
----------------------------------------------------------------------------------------------------------------
Skilled Nursing................. $132.83 $3.41 $136.24 8.81 $1,200.27
Physical Therapy................ 156.04 3.41 159.45 5.58 889.73
Occupational Therapy............ 153.53 3.41 156.94 1.56 244.83
Speech Pathology................ 170.06 3.41 173.47 0.32 55.51
Medical Social Services......... 219.73 3.41 223.14 0.14 31.24
Home Health Aides............... 60.50 3.41 63.91 1.83 116.96
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. 18.24 2,538.54
----------------------------------------------------------------------------------------------------------------
Source: Medicare cost reports pulled in March 2018 and Medicare claims data from 2015 and 2016 for episodes
(excluding low-utilization payment adjusted episodes and partial-episode-payment adjusted episodes), linked to
OASIS assessments for episodes ending in CY 2016.
2. Analysis of CY 2017 HHA Claims Data
In the CY 2014 HH PPS final rule (78 FR 72256), some commenters
expressed concern that the rebasing of the HH PPS payment rates would
result in HHA closures and would therefore diminish access to home
health services. In addition to examining more recent cost report data,
for this proposed rule we examined home health claims data from all
four years during which rebasing adjustments were made (CY 2014, CY
2015, CY 2016, and CY 2017), the first calendar year of the HH PPS (CY
2001), and claims data for the year prior to the implementation of the
rebasing adjustments (CY 2013). Preliminary analysis of CY 2017 home
health claims data indicates that the number of episodes decreased by
5.3 percent and the number of home health users that received at least
one episode of care decreased by 3.2 percent from 2016 to 2017, while
the number of FFS beneficiaries decreased 0.1 percent from 2016 to
2017. Between 2013 and 2014 there appears to be a net decrease in the
number of HHAs billing Medicare for home health services of 1.6
percent, a continued decrease of 1.7 percent from 2014 to 2015, a
decrease of 3.4 percent from 2015 to 2016, and a decrease of 4.4
percent from 2016 to 2017. We note that in CY 2016 there were 2.9 HHAs
per 10,000 FFS beneficiaries and 2.8 HHAs per 10,000 FFS beneficiaries
in CY 2017, which remains markedly higher than the 1.9 HHAs per 10,000
FFS beneficiaries close to the inception of the HH PPS in 2001 (the HH
PPS was implemented on October 1, 2000). The number of home health
users, as a percentage of FFS beneficiaries, has decreased from 9.0
percent in 2013 to 8.4 percent in 2017.
Table 3--Home Health Statistics, CY 2001 and CY 2013 Through CY 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
2001 2013 2014 2015 2016 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of episodes...................................... 3,896,502 6,708,923 6,451,283 6,340,932 6,294,234 5,963,780
Beneficiaries receiving at least 1 episode (Home Health 2,412,318 3,484,579 3,381,635 3,365,512 3,350,174 3,242,346
Users).................................................
Part A and/or B FFS beneficiaries....................... 34,899,167 38,505,609 38,506,534 38,506,534 38,555,150 38,509,031
Episodes per Part A and/or B FFS beneficiaries.......... 0.11 0.17 0.17 0.17 0.16 0.15
Home health users as a percentage of Part A and/or B FFS 6.9% 9.0% 8.8% 8.8% 8.7% 8.4%
beneficiaries..........................................
HHAs providing at least 1 episode....................... 6,511 11,889 11,693 11,381 11,102 10,612
HHAs per 10,000 Part A and/or B FFS beneficiaries....... 1.9 3.1 3.0 3.0 2.9 2.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)--Accessed on May 14, 2014 and August 19, 2014 for CY 2013
data; accessed on May 7, 2015 for CY 2001 and CY 2014 data; accessed on April 7, 2016 for CY 2015 data; accessed on March 20, 2017 for CY 2016 data;
accessed on March 8, 2018 for CY 2017 data; and Medicare enrollment information obtained from the CCW Master Beneficiary Summary File. Beneficiaries
are the total number of beneficiaries in a given year with at least 1 month of Part A and/or Part B Fee-for-Service coverage without having any months
of Medicare Advantage coverage.
Note(s): These results include all episode types (Normal, PEP, Outlier, LUPA) and also include episodes from outlying areas (outside of 50 States and
District of Columbia). Only episodes with a through date in the year specified are included. Episodes with a claim frequency code equal to ``0''
(``Non-payment/zero claims'') and ``2'' (``Interim--first claim'') are excluded. If a beneficiary is treated by providers from multiple states within
a year the beneficiary is counted within each state's unique number of beneficiaries served.
In addition to examining home health claims data from all four
years of the implementation of rebasing adjustments required by the
Affordable Care Act, we examined trends in home health utilization for
all years starting in CY 2001 and up through CY 2017. Figure 1,
displays the average number of visits per 60-day episode of care and
the average payment per visit. While the average payment per visit has
steadily increased from approximately $116 in CY 2001 to $170 for CY
2017, the average total number of visits per 60-day episode of care has
declined, most notably between CY 2009 (21.7 visits per episode) and CY
2010 (19.8 visits per episode), which was the first year that the 10
percent agency-level cap on HHA outlier payments was implemented. The
average of total visits per episode has steadily decreased from 21.7 in
2009 to 17.9 in 2017.
BILLING CODE 4120-01-P
[[Page 32350]]
TP12JY18.000
BILLING CODE 4120-01-C
Figure 2 displays the average number of visits by discipline type
for a 60-day episode of care and shows that while the number of therapy
visits per 60-day episode of care has increased steadily, the number of
skilled nursing and home health aide visits have decreased between CY
2009 and CY 2017. The results of the Report to Congress, ``Medicare
Home Health Study: An Investigation on Access to Care and Payment for
Vulnerable Patient Populations'', required by section 3131(d) of the
Affordable Care Act, suggests that the current home health payment
system may discourage HHAs from serving patients with clinically
complex and/or poorly controlled chronic conditions who do not qualify
for therapy but require a large number of skilled nursing visits.\5\
The home health study results seem to be consistent with the recent
trend in the decreased number of visits per episode of care driven by
decreases in skilled nursing and home health aide services evident in
Figures 1 and 2.
---------------------------------------------------------------------------
\5\ Report to Congress Medicare Home Health Study: An
Investigation on Access to Care and Payment for Vulnerable Patient
Populations (2014). Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/HH-Report-to-Congress.pdf.
---------------------------------------------------------------------------
[[Page 32351]]
TP12JY18.001
As part of our monitoring efforts, we also examined the trends in
episode timing and service use over time. Specifically, we examined the
percentage of early episodes with 0 to 19 therapy visits, late episodes
with 0 to 19 therapy visits, and episodes with 20+ therapy visits from
CY 2008 to CY 2017. In CY 2008, we implemented refinements to the HH
PPS case-mix system. As part of those refinements, we added additional
therapy thresholds and differentiated between early and late episodes
for those episodes with less than 20+ therapy visits. Early episodes
are defined as the 1st or 2nd episode in a sequence of adjacent covered
episodes. Late episodes are defined as the 3rd and subsequent episodes
in a sequence of adjacent covered episodes. Table 4 shows that the
percentage of early and late episodes from CY 2008 to CY 2017 has
remained relatively stable over time. There has been a decrease in the
percentage of early episodes with 0 to 19 therapy visits from 65.9
percent in CY 2008 to 61.3 percent in CY 2017 and a slight increase in
the percentage of late episodes with 0 to 19 therapy visits from 29.5
percent in CY 2008 to 31.2 percent in CY 2017. In 2015, the case-mix
weights for the third and later episodes of care with 0 to 19 therapy
visits decreased as a result of the CY 2015 recalibration of the case-
mix weights. Despite the decreases in the case-mix weights for the
later episodes, the percentage of late episodes with 0 to 19 therapy
visits did not change substantially. However, episode timing is not a
variable in the determination of the case-mix weights for those
episodes with 20+ therapy visits and the percentage of episodes with
20+ therapy visits has increased from 4.6 percent in CY 2008 to 7.6
percent in CY 2017.
[[Page 32352]]
Table 4--Home Health Episodes by Episode Timing, CY 2008 Through CY 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of % of early Number of late % of late
early episodes episodes episodes episodes Number of % of episodes
Year All episodes (excluding (excluding (excluding (excluding episodes with with 20+
episodes with episodes with episodes with episodes with 20+ visits visits
20+ visits) 20+ visits) 20+ visits) 20+ visits)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2008.................................... 5,423,037 3,571,619 65.9 1,600,587 29.5 250,831 4.6
2009.................................... 6,530,200 3,701,652 56.7 2,456,308 37.6 372,240 5.7
2010.................................... 6,877,598 3,872,504 56.3 2,586,493 37.6 418,601 6.1
2011.................................... 6,857,885 3,912,982 57.1 2,564,859 37.4 380,044 5.5
2012.................................... 6,767,576 3,955,207 58.4 2,458,734 36.3 353,635 5.2
2013.................................... 6,733,146 4,023,486 59.8 2,347,420 34.9 362,240 5.4
2014.................................... 6,616,875 3,980,151 60.2 2,263,638 34.2 373,086 5.6
2015.................................... 6,644,922 4,008,279 60.3 2,205,052 33.2 431,591 6.5
2016.................................... 6,294,232 3,802,254 60.4 2,053,972 32.6 438,006 7.0
2017.................................... 5,963,778 3,655,636 61.3 1,857,840 31.2 450,302 7.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)--Accessed on March 6, 2018.
Note(s): Only episodes with a through date in the year specified are included. Episodes with a claim frequency code equal to ``0'' (``Non-payment/zero
claims'') and ``2'' (``Interim--first claim'') are excluded.
We also examined trends in admission source for home health
episodes over time. Specifically, we examined the admission source for
the ``first or only'' episodes of care (first episodes in a sequence of
adjacent episodes of care or the only episode of care) from CY 2008
through CY 2017 (Figure 3). The percentage of first or only episodes
with an acute admission source, defined as episodes with an inpatient
hospital stay within the 14 days prior to a home health episode, has
decreased from 38.6 percent in CY 2008 to 34.8 percent in CY 2017. The
percentage of first or only episodes with a post-acute admission
source, defined as episodes which had a stay at a skilled nursing
facility (SNF), inpatient rehabilitation facility (IRF), or long term
care hospital (LTCH) within 14 days prior to the home health episode,
has slightly increased from 16.4 percent in CY 2008 to 17.6 percent in
CY 2017. The percentage of first or only episodes with a community
admission source, defined as episodes which did not have an acute or
post-acute stay in the 14 days prior to the home health episode,
increased from 37.4 percent in CY 2008 to 41.5 percent in CY 2017. Our
findings on the trends in admission source show a similar pattern with
MedPAC's as outlined in their 2015 Report to the Congress.\6\ MedPAC
concluded that there has been tremendous growth in the use of home
health for patients residing in the community (that is, episodes not
preceded by a prior hospitalization) and that these episodes have more
than doubled since 2001. However, MedPAC examined admission source
trends from 2002 up through 2013 and included first and subsequent
episodes of care, whereas CMS analysis, as described above, included
``first or only'' episodes of care. Nonetheless, both analyses show a
trend of increasing episodes of care without a preceding inpatient
stay. MedPAC suggests there is significant potential for overuse,
particularly since Medicare does not currently require any cost sharing
for home health care.
---------------------------------------------------------------------------
\6\ Medicare Payment Advisory Commission (MedPAC). ``Home Health
Care Services.'' Report to the Congress: Medicare Payment Policy.
Washington, DC, March 2015. P. 214. Accessed on 3/28/2017 at: http://www.medpac.gov/docs/default-source/reports/chapter-9-home-health-care-services-march-2015-report-.pdf?sfvrsn=0.
---------------------------------------------------------------------------
[[Page 32353]]
TP12JY18.002
We will continue to monitor for potential impacts due to the
rebasing adjustments required by section 3131(a) of the Affordable Care
Act and other policy changes in the future. Independent effects of any
one policy may be difficult to discern in years where multiple policy
changes occur in any given year.
B. Proposed CY 2019 HH PPS Case-Mix Weights
In the CY 2015 HH PPS final rule (79 FR 66072), we finalized a
policy to annually recalibrate the HH PPS case-mix weights--adjusting
the weights relative to one another--using the most current, complete
data available. To recalibrate the HH PPS case-mix weights for CY 2018,
we will use the same methodology finalized in the CY 2008 HH PPS final
rule (72 FR 49762), the CY 2012 HH PPS final rule (76 FR 68526), and
the CY 2015 HH PPS final rule (79 FR 66032). Annual recalibration of
the HH PPS case-mix weights ensures that the case-mix weights reflect,
as accurately as possible, current home health resource use and changes
in utilization patterns.
To generate the proposed CY 2019 HH PPS case-mix weights, we used
CY 2017 home health claims data (as of March 2, 2018) with linked OASIS
data. These data are the most current and complete data available at
this time. We will use CY 2017 home health claims data (as of June 30,
2018 or later) with linked OASIS data to generate the CY 2019 HH PPS
case-mix weights in the CY 2019 HH PPS final rule. The process we used
to calculate the HH PPS case-mix weights are outlined below.
Step 1: Re-estimate the four-equation model to determine the
clinical and functional points for an episode using wage-weighted
minutes of care as our dependent variable for resource use. The wage-
weighted minutes of care are determined using the CY 2016 Bureau of
Labor Statistics national hourly wage plus fringe rates for the six
home health disciplines and the minutes per visit from the claim. The
points for each of the variables for each leg of the model, updated
with CY 2017 home health claims data, are shown in Table 5. The points
for the clinical variables are added together to determine an episode's
clinical score. The points for the functional variables are added
together to determine an episode's functional score.
BILLING CODE 4120-01-P
[[Page 32354]]
TP12JY18.014
[[Page 32355]]
TP12JY18.015
[[Page 32356]]
TP12JY18.016
BILLING CODE 4120-01-C
In updating the four-equation model for CY 2019, using 2017 home
health claims data (the last update to the four-equation model for CY
2018 used CY 2016 home health claims data), there were few changes to
the point values for the variables in the four-equation model. These
relatively minor changes reflect the change in the relationship between
the grouper variables and resource use between CY 2016 and CY 2017. The
CY 2019 four-equation model resulted in 113 point-giving variables
being used in the model (as compared to the 119 variables for the CY
2018 recalibration, which can be found in Table 2 of the CY 2018 HH PPS
final rule (82 FR 51684)). There were 7 variables that were added to
the model and 13 variables that were dropped from the model due to the
absence of additional resources associated with the variable. Of the
variables that were in both the four-equation model for CY 2019 and the
four-equation model for CY 2018, the points for 10 variables increased
in the CY 2019 four-equation model and the points for 67 variables
decreased in the CY 2019 4-equation model. There were 29 variables with
the same point values.
Step 2: Re-defining the clinical and functional thresholds so they
are reflective of the new points associated with the CY 2019 four-
equation model. After estimating the points for each of the variables
and summing the clinical and functional points for each episode, we
look at the distribution of the clinical score and functional score,
breaking the episodes into different steps. The categorizations for the
steps are as follows:
Step 1: First and second episodes, 0-13 therapy visits.
Step 2.1: First and second episodes, 14-19 therapy visits.
Step 2.2: Third episodes and beyond, 14-19 therapy visits.
Step 3: Third episodes and beyond, 0-13 therapy visits.
Step 4: Episodes with 20+ therapy visits.
We then divide the distribution of the clinical score for episodes
within a step such that a third of episodes are classified as low
clinical score, a third of episodes are classified as medium clinical
score, and a third of episodes are classified as high clinical score.
The same approach is then done looking at the functional score. It was
not always possible to evenly divide the episodes within each step into
thirds due to many episodes being clustered around one particular
score.\7\ Also, we looked at the average resource use associated with
each clinical and functional score and used that as a guide for setting
our thresholds. We grouped scores with similar average resource use
within the same level (even if it meant that more or less than a third
of episodes were placed within a level). The new thresholds, based off
the CY 2019 four-equation model points are shown in Table 6.
---------------------------------------------------------------------------
\7\ For Step 1, 41% of episodes were in the medium functional
level (All with score 13).
For Step 2.1, 86.7% of episodes were in the low functional level
(Most with scores 6 to 7).
For Step 2.2, 81.5% of episodes were in the low functional level
(Most with score 0).
For Step 3, 46.7% of episodes were in the medium functional
level (Most with score 9).
For Step 4, 29.9% of episodes were in the medium functional
level (Most with score 6).
Table 6--Proposed CY 2019 Clinical and Functional Thresholds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1st and 2nd Episodes 3rd+ Episodes All Episodes
----------------------------------------------------------------------------------------------------------------------------------------
0 to 13 therapy visits 14 to 19 therapy visits 0 to 13 therapy visits 14 to 19 therapy visits 20+ therapy visits
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Grouping Step 1......................... 2......................... 3........................ 4........................ 5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Equations used to calculate points 1......................... 2......................... 3........................ 4........................ (2&4)
(see Table 2)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dimension Severity Level .......................... .......................... ......................... ......................... .........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical.......................... C1................. 0 to 1.................... 0 to 1.................... 0 to 1................... 0 to 1................... 0 to 3.
C2................. 2 to 3.................... 2 to 7.................... 2........................ 2 to 9................... 4 to 16.
C3................. 4+........................ 8+........................ 3+....................... 10+...................... 17+.
Functional........................ F1................. 0 to 12................... 0 to 7.................... 0 to 6................... 0 to 2................... 0 to 2.
F2................. 13........................ 8 to 12................... 7 to 10.................. 3 to 7................... 3 to 6.
F3................. 14+....................... 13+....................... 11+...................... 8+....................... 7+.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Step 3: Once the clinical and functional thresholds are determined
and each episode is assigned a clinical and functional level, the
payment regression is estimated with an episode's wage-weighted minutes
of care as the dependent variable. Independent variables in the model
are indicators for the step of the episode as well as the clinical and
functional levels within each step of the episode. Like the four-
equation model, the payment regression model is also estimated with
robust standard errors that are clustered at the beneficiary level.
Table 7 shows the regression coefficients for the variables in the
payment regression model updated with CY 2017 home
[[Page 32357]]
health claims data. The R-squared value for the payment regression
model is 0.5508 (an increase from 0.5095 for the CY 2018
recalibration).
Table 7--Payment Regression Model
------------------------------------------------------------------------
Payment
regression
from 4-
equation model
for CY 2019
------------------------------------------------------------------------
Step 1, Clinical Score Medium........................... $21.81
Step 1, Clinical Score High............................. 54.06
Step 1, Functional Score Medium......................... 70.54
Step 1, Functional Score High........................... 99.78
Step 2.1, Clinical Score Medium......................... 50.90
Step 2.1, Clinical Score High........................... 118.77
Step 2.1, Functional Score Medium....................... 25.36
Step 2.1, Functional Score High......................... 31.96
Step 2.2, Clinical Score Medium......................... 48.03
Step 2.2, Clinical Score High........................... 187.73
Step 2.2, Functional Score Medium....................... 50.06
Step 2.2, Functional Score High......................... 0.00
Step 3, Clinical Score Medium........................... 18.05
Step 3, Clinical Score High............................. 83.67
Step 3, Functional Score Medium......................... 56.10
Step 3, Functional Score High........................... 81.90
Step 4, Clinical Score Medium........................... 70.97
Step 4, Clinical Score High............................. 245.97
Step 4, Functional Score Medium......................... 4.60
Step 4, Functional Score High........................... 17.77
Step 2.1, 1st and 2nd Episodes, 14 to 19 Therapy Visits. 515.04
Step 2.2, 3rd+ Episodes, 14 to 19 Therapy Visits........ 510.26
Step 3, 3rd+ Episodes, 0-13 Therapy Visits.............. -60.34
Step 4, All Episodes, 20+ Therapy Visits................ 895.79
Intercept............................................... 375.32
------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before
December 31, 2017 (as of March 2, 2018) for which we had a linked
OASIS assessment.
Step 4: We use the coefficients from the payment regression model
to predict each episode's wage-weighted minutes of care (resource use).
We then divide these predicted values by the mean of the dependent
variable (that is, the average wage-weighted minutes of care across all
episodes used in the payment regression). This division constructs the
weight for each episode, which is simply the ratio of the episode's
predicted wage-weighted minutes of care divided by the average wage-
weighted minutes of care in the sample. Each episode is then aggregated
into one of the 153 home health resource groups (HHRGs) and the ``raw''
weight for each HHRG was calculated as the average of the episode
weights within the HHRG.
Step 5: The raw weights associated with 0 to 5 therapy visits are
then increased by 3.75 percent, the weights associated with 14-15
therapy visits are decreased by 2.5 percent, and the weights associated
with 20+ therapy visits are decreased by 5 percent. These adjustments
to the case-mix weights were finalized in the CY 2012 HH PPS final rule
(76 FR 68557) and were done to address MedPAC's concerns that the HH
PPS overvalues therapy episodes and undervalues non-therapy episodes
and to better align the case-mix weights with episode costs estimated
from cost report data.\8\
---------------------------------------------------------------------------
\8\ Medicare Payment Advisory Commission (MedPAC), Report to the
Congress: Medicare Payment Policy. March 2011, P. 176.
---------------------------------------------------------------------------
Step 6: After the adjustments in step 5 are applied to the raw
weights, the weights are further adjusted to create an increase in the
payment weights for the therapy visit steps between the therapy
thresholds. Weights with the same clinical severity level, functional
severity level, and early/later episode status were grouped together.
Then within those groups, the weights for each therapy step between
thresholds are gradually increased. We do this by interpolating between
the main thresholds on the model (from 0-5 to 14-15 therapy visits, and
from 14-15 to 20+ therapy visits). We use a linear model to implement
the interpolation so the payment weight increase for each step between
the thresholds (such as the increase between 0-5 therapy visits and 6
therapy visits and the increase between 6 therapy visits and 7-9
therapy visits) are constant. This interpolation is identical to the
process finalized in the CY 2012 HH PPS final rule (76 FR 68555).
Step 7: The interpolated weights are then adjusted so that the
average case-mix for the weights is equal to 1.0000.\9\ This last step
creates the proposed CY 2019 case-mix weights shown in Table 8.
---------------------------------------------------------------------------
\9\ When computing the average, we compute a weighted average,
assigning a value of one to each normal episode and a value equal to
the episode length divided by 60 for PEPs.
[[Page 32358]]
Table 8--Proposed Cy 2019 Case-Mix Payment Weights
----------------------------------------------------------------------------------------------------------------
Clinical and functional Proposed
Pay group Description levels (1 = low; 2 = medium; weights for CY
3 = high) 2019
----------------------------------------------------------------------------------------------------------------
10111........................ 1st and 2nd Episodes, 0 to 5 C1F1S1 0.5459
Therapy Visits.
10112........................ 1st and 2nd Episodes, 6 Therapy C1F1S2 0.6801
Visits.
10113........................ 1st and 2nd Episodes, 7 to 9 C1F1S3 0.8143
Therapy Visits.
10114........................ 1st and 2nd Episodes, 10 Therapy C1F1S4 0.9485
Visits.
10115........................ 1st and 2nd Episodes, 11 to 13 C1F1S5 1.0828
Therapy Visits.
10121........................ 1st and 2nd Episodes, 0 to 5 C1F2S1 0.6485
Therapy Visits.
10122........................ 1st and 2nd Episodes, 6 Therapy C1F2S2 0.7691
Visits.
10123........................ 1st and 2nd Episodes, 7 to 9 C1F2S3 0.8897
Therapy Visits.
10124........................ 1st and 2nd Episodes, 10 Therapy C1F2S4 1.0104
Visits.
10125........................ 1st and 2nd Episodes, 11 to 13 C1F2S5 1.1310
Therapy Visits.
10131........................ 1st and 2nd Episodes, 0 to 5 C1F3S1 0.6910
Therapy Visits.
10132........................ 1st and 2nd Episodes, 6 Therapy C1F3S2 0.8049
Visits.
10133........................ 1st and 2nd Episodes, 7 to 9 C1F3S3 0.9189
Therapy Visits.
10134........................ 1st and 2nd Episodes, 10 Therapy C1F3S4 1.0328
Visits.
10135........................ 1st and 2nd Episodes, 11 to 13 C1F3S5 1.1467
Therapy Visits.
10211........................ 1st and 2nd Episodes, 0 to 5 C2F1S1 0.5776
Therapy Visits.
10212........................ 1st and 2nd Episodes, 6 Therapy C2F1S2 0.7194
Visits.
10213........................ 1st and 2nd Episodes, 7 to 9 C2F1S3 0.8612
Therapy Visits.
10214........................ 1st and 2nd Episodes, 10 Therapy C2F1S4 1.0030
Visits.
10215........................ 1st and 2nd Episodes, 11 to 13 C2F1S5 1.1448
Therapy Visits.
10221........................ 1st and 2nd Episodes, 0 to 5 C2F2S1 0.6802
Therapy Visits.
10222........................ 1st and 2nd Episodes, 6 Therapy C2F2S2 0.8084
Visits.
10223........................ 1st and 2nd Episodes, 7 to 9 C2F2S3 0.9366
Therapy Visits.
10224........................ 1st and 2nd Episodes, 10 Therapy C2F2S4 1.0648
Visits.
10225........................ 1st and 2nd Episodes, 11 to 13 C2F2S5 1.1930
Therapy Visits.
10231........................ 1st and 2nd Episodes, 0 to 5 C2F3S1 0.7227
Therapy Visits.
10232........................ 1st and 2nd Episodes, 6 Therapy C2F3S2 0.8442
Visits.
10233........................ 1st and 2nd Episodes, 7 to 9 C2F3S3 0.9657
Therapy Visits.
10234........................ 1st and 2nd Episodes, 10 Therapy C2F3S4 1.0872
Visits.
10235........................ 1st and 2nd Episodes, 11 to 13 C2F3S5 1.2087
Therapy Visits.
10311........................ 1st and 2nd Episodes, 0 to 5 C3F1S1 0.6245
Therapy Visits.
10312........................ 1st and 2nd Episodes, 6 Therapy C3F1S2 0.7755
Visits.
10313........................ 1st and 2nd Episodes, 7 to 9 C3F1S3 0.9264
Therapy Visits.
10314........................ 1st and 2nd Episodes, 10 Therapy C3F1S4 1.0774
Visits.
10315........................ 1st and 2nd Episodes, 11 to 13 C3F1S5 1.2284
Therapy Visits.
10321........................ 1st and 2nd Episodes, 0 to 5 C3F2S1 0.7271
Therapy Visits.
10322........................ 1st and 2nd Episodes, 6 Therapy C3F2S2 0.8645
Visits.
10323........................ 1st and 2nd Episodes, 7 to 9 C3F2S3 1.0019
Therapy Visits.
10324........................ 1st and 2nd Episodes, 10 Therapy C3F2S4 1.1392
Visits.
10325........................ 1st and 2nd Episodes, 11 to 13 C3F2S5 1.2766
Therapy Visits.
10331........................ 1st and 2nd Episodes, 0 to 5 C3F3S1 0.7696
Therapy Visits.
10332........................ 1st and 2nd Episodes, 6 Therapy C3F3S2 0.9003
Visits.
10333........................ 1st and 2nd Episodes, 7 to 9 C3F3S3 1.0310
Therapy Visits.
10334........................ 1st and 2nd Episodes, 10 Therapy C3F3S4 1.1617
Visits.
10335........................ 1st and 2nd Episodes, 11 to 13 C3F3S5 1.2923
Therapy Visits.
21111........................ 1st and 2nd Episodes, 14 to 15 C1F1S1 1.2170
Therapy Visits.
21112........................ 1st and 2nd Episodes, 16 to 17 C1F1S2 1.3756
Therapy Visits.
21113........................ 1st and 2nd Episodes, 18 to 19 C1F1S3 1.5342
Therapy Visits.
21121........................ 1st and 2nd Episodes, 14 to 15 C1F2S1 1.2516
Therapy Visits.
21122........................ 1st and 2nd Episodes, 16 to 17 C1F2S2 1.4008
Therapy Visits.
21123........................ 1st and 2nd Episodes, 18 to 19 C1F2S3 1.5499
Therapy Visits.
21131........................ 1st and 2nd Episodes, 14 to 15 C1F3S1 1.2607
Therapy Visits.
21132........................ 1st and 2nd Episodes, 16 to 17 C1F3S2 1.4126
Therapy Visits.
21133........................ 1st and 2nd Episodes, 18 to 19 C1F3S3 1.5646
Therapy Visits.
21211........................ 1st and 2nd Episodes, 14 to 15 C2F1S1 1.2866
Therapy Visits.
21212........................ 1st and 2nd Episodes, 16 to 17 C2F1S2 1.4535
Therapy Visits.
21213........................ 1st and 2nd Episodes, 18 to 19 C2F1S3 1.6204
Therapy Visits.
21221........................ 1st and 2nd Episodes, 14 to 15 C2F2S1 1.3212
Therapy Visits.
21222........................ 1st and 2nd Episodes, 16 to 17 C2F2S2 1.4786
Therapy Visits.
21223........................ 1st and 2nd Episodes, 18 to 19 C2F2S3 1.6361
Therapy Visits.
21231........................ 1st and 2nd Episodes, 14 to 15 C2F3S1 1.3302
Therapy Visits.
21232........................ 1st and 2nd Episodes, 16 to 17 C2F3S2 1.4905
Therapy Visits.
21233........................ 1st and 2nd Episodes, 18 to 19 C2F3S3 1.6508
Therapy Visits.
21311........................ 1st and 2nd Episodes, 14 to 15 C3F1S1 1.3793
Therapy Visits.
21312........................ 1st and 2nd Episodes, 16 to 17 C3F1S2 1.5930
Therapy Visits.
21313........................ 1st and 2nd Episodes, 18 to 19 C3F1S3 1.8067
Therapy Visits.
21321........................ 1st and 2nd Episodes, 14 to 15 C3F2S1 1.4140
Therapy Visits.
21322........................ 1st and 2nd Episodes, 16 to 17 C3F2S2 1.6182
Therapy Visits.
[[Page 32359]]
21323........................ 1st and 2nd Episodes, 18 to 19 C3F2S3 1.8224
Therapy Visits.
21331........................ 1st and 2nd Episodes, 14 to 15 C3F3S1 1.4230
Therapy Visits.
21332........................ 1st and 2nd Episodes, 16 to 17 C3F3S2 1.6300
Therapy Visits.
21333........................ 1st and 2nd Episodes, 18 to 19 C3F3S3 1.8371
Therapy Visits.
22111........................ 3rd+ Episodes, 14 to 15 Therapy C1F1S1 1.2104
Visits.
22112........................ 3rd+ Episodes, 16 to 17 Therapy C1F1S2 1.3713
Visits.
22113........................ 3rd+ Episodes, 18 to 19 Therapy C1F1S3 1.5321
Visits.
22121........................ 3rd+ Episodes, 14 to 15 Therapy C1F2S1 1.2789
Visits.
22122........................ 3rd+ Episodes, 16 to 17 Therapy C1F2S2 1.4189
Visits.
22123........................ 3rd+ Episodes, 18 to 19 Therapy C1F2S3 1.5589
Visits.
22131........................ 3rd+ Episodes, 14 to 15 Therapy C1F3S1 1.2789
Visits.
22132........................ 3rd+ Episodes, 16 to 17 Therapy C1F3S2 1.4248
Visits.
22133........................ 3rd+ Episodes, 18 to 19 Therapy C1F3S3 1.5706
Visits.
22211........................ 3rd+ Episodes, 14 to 15 Therapy C2F1S1 1.2761
Visits.
22212........................ 3rd+ Episodes, 16 to 17 Therapy C2F1S2 1.4465
Visits.
22213........................ 3rd+ Episodes, 18 to 19 Therapy C2F1S3 1.6169
Visits.
22221........................ 3rd+ Episodes, 14 to 15 Therapy C2F2S1 1.3445
Visits.
22222........................ 3rd+ Episodes, 16 to 17 Therapy C2F2S2 1.4942
Visits.
22223........................ 3rd+ Episodes, 18 to 19 Therapy C2F2S3 1.6438
Visits.
22231........................ 3rd+ Episodes, 14 to 15 Therapy C2F3S1 1.3445
Visits.
22232........................ 3rd+ Episodes, 16 to 17 Therapy C2F3S2 1.5000
Visits.
22233........................ 3rd+ Episodes, 18 to 19 Therapy C2F3S3 1.6555
Visits.
22311........................ 3rd+ Episodes, 14 to 15 Therapy C3F1S1 1.4670
Visits.
22312........................ 3rd+ Episodes, 16 to 17 Therapy C3F1S2 1.6515
Visits.
22313........................ 3rd+ Episodes, 18 to 19 Therapy C3F1S3 1.8360
Visits.
22321........................ 3rd+ Episodes, 14 to 15 Therapy C3F2S1 1.5355
Visits.
22322........................ 3rd+ Episodes, 16 to 17 Therapy C3F2S2 1.6992
Visits.
22323........................ 3rd+ Episodes, 18 to 19 Therapy C3F2S3 1.8629
Visits.
22331........................ 3rd+ Episodes, 14 to 15 Therapy C3F3S1 1.5355
Visits.
22332........................ 3rd+ Episodes, 16 to 17 Therapy C3F3S2 1.7050
Visits.
22333........................ 3rd+ Episodes, 18 to 19 Therapy C3F3S3 1.8746
Visits.
30111........................ 3rd+ Episodes, 0 to 5 Therapy C1F1S1 0.4581
Visits.
30112........................ 3rd+ Episodes, 6 Therapy Visits.. C1F1S2 0.6086
30113........................ 3rd+ Episodes, 7 to 9 Therapy C1F1S3 0.7591
Visits.
30114........................ 3rd+ Episodes, 10 Therapy Visits. C1F1S4 0.9095
30115........................ 3rd+ Episodes, 11 to 13 Therapy C1F1S5 1.0600
Visits.
30121........................ 3rd+ Episodes, 0 to 5 Therapy C1F2S1 0.5397
Visits.
30122........................ 3rd+ Episodes, 6 Therapy Visits.. C1F2S2 0.6876
30123........................ 3rd+ Episodes, 7 to 9 Therapy C1F2S3 0.8354
Visits.
30124........................ 3rd+ Episodes, 10 Therapy Visits. C1F2S4 0.9832
30125........................ 3rd+ Episodes, 11 to 13 Therapy C1F2S5 1.1310
Visits.
30131........................ 3rd+ Episodes, 0 to 5 Therapy C1F3S1 0.5772
Visits.
30132........................ 3rd+ Episodes, 6 Therapy Visits.. C1F3S2 0.7176
30133........................ 3rd+ Episodes, 7 to 9 Therapy C1F3S3 0.8579
Visits.
30134........................ 3rd+ Episodes, 10 Therapy Visits. C1F3S4 0.9982
30135........................ 3rd+ Episodes, 11 to 13 Therapy C1F3S5 1.1385
Visits.
30211........................ 3rd+ Episodes, 0 to 5 Therapy C2F1S1 0.4844
Visits.
30212........................ 3rd+ Episodes, 6 Therapy Visits.. C2F1S2 0.6427
30213........................ 3rd+ Episodes, 7 to 9 Therapy C2F1S3 0.8011
Visits.
30214........................ 3rd+ Episodes, 10 Therapy Visits. C2F1S4 0.9594
30215........................ 3rd+ Episodes, 11 to 13 Therapy C2F1S5 1.1178
Visits.
30221........................ 3rd+ Episodes, 0 to 5 Therapy C2F2S1 0.5660
Visits.
30222........................ 3rd+ Episodes, 6 Therapy Visits.. C2F2S2 0.7217
30223........................ 3rd+ Episodes, 7 to 9 Therapy C2F2S3 0.8774
Visits.
30224........................ 3rd+ Episodes, 10 Therapy Visits. C2F2S4 1.0331
30225........................ 3rd+ Episodes, 11 to 13 Therapy C2F2S5 1.1888
Visits.
30231........................ 3rd+ Episodes, 0 to 5 Therapy C2F3S1 0.6035
Visits.
30232........................ 3rd+ Episodes, 6 Therapy Visits.. C2F3S2 0.7517
30233........................ 3rd+ Episodes, 7 to 9 Therapy C2F3S3 0.8999
Visits.
30234........................ 3rd+ Episodes, 10 Therapy Visits. C2F3S4 1.0481
30235........................ 3rd+ Episodes, 11 to 13 Therapy C2F3S5 1.1963
Visits.
30311........................ 3rd+ Episodes, 0 to 5 Therapy C3F1S1 0.5798
Visits.
30312........................ 3rd+ Episodes, 6 Therapy Visits.. C3F1S2 0.7573
30313........................ 3rd+ Episodes, 7 to 9 Therapy C3F1S3 0.9347
Visits.
30314........................ 3rd+ Episodes, 10 Therapy Visits. C3F1S4 1.1122
30315........................ 3rd+ Episodes, 11 to 13 Therapy C3F1S5 1.2896
Visits.
30321........................ 3rd+ Episodes, 0 to 5 Therapy C3F2S1 0.6614
Visits.
30322........................ 3rd+ Episodes, 6 Therapy Visits.. C3F2S2 0.8362
[[Page 32360]]
30323........................ 3rd+ Episodes, 7 to 9 Therapy C3F2S3 1.0110
Visits.
30324........................ 3rd+ Episodes, 10 Therapy Visits. C3F2S4 1.1858
30325........................ 3rd+ Episodes, 11 to 13 Therapy C3F2S5 1.3607
Visits.
30331........................ 3rd+ Episodes, 0 to 5 Therapy C3F3S1 0.6989
Visits.
30332........................ 3rd+ Episodes, 6 Therapy Visits.. C3F3S2 0.8662
30333........................ 3rd+ Episodes, 7 to 9 Therapy C3F3S3 1.0336
Visits.
30334........................ 3rd+ Episodes, 10 Therapy Visits. C3F3S4 1.2009
30335........................ 3rd+ Episodes, 11 to 13 Therapy C3F3S5 1.3682
Visits.
40111........................ All Episodes, 20+ Therapy Visits. C1F1S1 1.6929
40121........................ All Episodes, 20+ Therapy Visits. C1F2S1 1.6990
40131........................ All Episodes, 20+ Therapy Visits. C1F3S1 1.7165
40211........................ All Episodes, 20+ Therapy Visits. C2F1S1 1.7874
40221........................ All Episodes, 20+ Therapy Visits. C2F2S1 1.7935
40231........................ All Episodes, 20+ Therapy Visits. C2F3S1 1.8110
40311........................ All Episodes, 20+ Therapy Visits. C3F1S1 2.0204
40321........................ All Episodes, 20+ Therapy Visits. C3F2S1 2.0266
40331........................ All Episodes, 20+ Therapy Visits. C3F3S1 2.0441
----------------------------------------------------------------------------------------------------------------
To ensure the changes to the HH PPS case-mix weights are
implemented in a budget neutral manner, we then apply a case-mix budget
neutrality factor to the proposed CY 2019 national, standardized 60-day
episode payment rate (see section III.C.3. of this proposed rule). The
case-mix budget neutrality factor is calculated as the ratio of total
payments when the CY 2019 HH PPS case-mix weights (developed using CY
2017 home health claims data) are applied to CY 2017 utilization
(claims) data to total payments when CY 2018 HH PPS case-mix weights
(developed using CY 2016 home health claims data) are applied to CY
2017 utilization data. This produces a case-mix budget neutrality
factor for CY 2019 of 1.0163.
C. CY 2019 Home Health Payment Rate Update
1. Rebasing and Revising of the Home Health Market Basket
a. Background
Section 1895(b)(3)(B) of the Act requires that the standard
prospective payment amounts for CY 2019 be increased by a factor equal
to the applicable home health market basket update for those HHAs that
submit quality data as required by the Secretary. Effective for cost
reporting periods beginning on or after July 1, 1980, we developed and
adopted an HHA input price index (that is, the home health ``market
basket''). Although ``market basket'' technically describes the mix of
goods and services used to produce home health care, this term is also
commonly used to denote the input price index derived from that market
basket. Accordingly, the term ``home health market basket'' used in
this document refers to the HHA input price index.
The percentage change in the home health market basket reflects the
average change in the price of goods and services purchased by HHAs in
providing an efficient level of home health care services. We first
used the home health market basket to adjust HHA cost limits by an
amount that reflected the average increase in the prices of the goods
and services used to furnish reasonable cost home health care. This
approach linked the increase in the cost limits to the efficient
utilization of resources. For a greater discussion on the home health
market basket, see the notice with comment period published in the
February 15, 1980 Federal Register (45 FR 10450, 10451), the notice
with comment period published in the February 14, 1995 Federal Register
(60 FR 8389, 8392), and the notice with comment period published in the
July 1, 1996 Federal Register (61 FR 34344, 34347). Beginning with the
FY 2002 HHA PPS payments, we used the home health market basket to
update payments under the HHA PPS. We last rebased the home health
market basket effective with the CY 2013 update (77 FR 67081).
The home health market basket is a fixed-weight, Laspeyres-type
price index. A Laspeyres-type price index measures the change in price,
over time, of the same mix of goods and services purchased in the base
period. Any changes in the quantity or mix of goods and services (that
is, intensity) purchased over time are not measured.
The index itself is constructed in three steps. First, a base
period is selected (in this proposed rule, we are proposing to use 2016
as the base period) and total base period expenditures are estimated
for a set of mutually exclusive and exhaustive spending categories,
with the proportion of total costs that each category represents being
calculated. These proportions are called ``cost weights'' or
``expenditure weights.'' Second, each expenditure category is matched
to an appropriate price or wage variable, referred to as a ``price
proxy.'' In almost every instance, these price proxies are derived from
publicly available statistical series that are published on a
consistent schedule (preferably at least on a quarterly basis).
Finally, the expenditure weight for each cost category is multiplied by
the level of its respective price proxy. The sum of these products
(that is, the expenditure weights multiplied by their price index
levels) for all cost categories yields the composite index level of the
market basket in a given period. Repeating this step for other periods
produces a series of market basket levels over time. Dividing an index
level for a given period by an index level for an earlier period
produces a rate of growth in the input price index over that timeframe.
As noted previously, the market basket is described as a fixed-
weight index because it represents the change in price over time of a
constant mix (quantity and intensity) of goods and services needed to
provide HHA services. The effects on total expenditures resulting from
changes in the mix of goods and services purchased
[[Page 32361]]
subsequent to the base period are not measured. For example, a HHA
hiring more nurses to accommodate the needs of patients would increase
the volume of goods and services purchased by the HHA, but would not be
factored into the price change measured by a fixed-weight home health
market basket. Only when the index is rebased would changes in the
quantity and intensity be captured, with those changes being reflected
in the cost weights. Therefore, we rebase the market basket
periodically so that the cost weights reflect recent changes in the mix
of goods and services that HHAs purchase (HHA inputs) to furnish
inpatient care between base periods.
b. Rebasing and Revising the Home Health Market Basket
We believe that it is desirable to rebase the home health market
basket periodically so that the cost category weights reflect changes
in the mix of goods and services that HHAs purchase in furnishing home
health care. We based the cost category weights in the current home
health market basket on CY 2010 data. We are proposing to rebase and
revise the home health market basket to reflect 2016 Medicare cost
report (MCR) data, the latest available and most complete data on the
actual structure of HHA costs.
The terms ``rebasing'' and ``revising,'' while often used
interchangeably, denote different activities. The term ``rebasing''
means moving the base year for the structure of costs of an input price
index (that is, in this exercise, we are proposing to move the base
year cost structure from CY 2010 to CY 2016) without making any other
major changes to the methodology. The term ``revising'' means changing
data sources, cost categories, and/or price proxies used in the input
price index.
For this proposed rebasing and revising, we are rebasing the
detailed wages and salaries and benefits cost weights to reflect 2016
BLS Occupational Employment Statistics (OES) data on HHAs. The 2010-
based home health market basket used 2010 BLS OES data on HHAs. We are
also proposing to break out the All Other (residual) cost category
weight into more detailed cost categories, based on the 2007 Benchmark
U.S. Department of Commerce, Bureau of Economic Analysis (BEA) Input-
Output (I-O) Table for HHAs. The 2010-based home health market basket
used the 2002 I-O data. Finally, due to its small weight, we are
proposing to eliminate the cost category `Postage' and include these
expenses in the `All Other Services' cost weight.
c. Derivation of the Proposed 2016-Based Home Health Market Basket Cost
Weights
The major cost weights for this proposed revised and rebased home
health market basket are derived from the Medicare Cost Reports (MCR;
CMS Form 1728-94) data for freestanding HHAs whose cost reporting
period began on or after October 1, 2015 and before October 1, 2016. Of
the 2016 Medicare cost reports for freestanding HHAs, approximately 84
percent of the reports had a begin date on January 1, 2016,
approximately 6 percent had a begin date on July 1, 2016, and
approximately 4 percent had a begin date on October 1, 2015. Using this
methodology allowed our sample to include HHAs with varying cost report
years including, but not limited to, the Federal fiscal or calendar
year. We refer to the market basket as a calendar year market basket
because the base period for all price proxies and weights are set to CY
2016.
We propose to maintain our policy of using data from freestanding
HHAs, which account for over 90 percent of HHAs (82 FR 35383), because
we have determined that they better reflect HHAs' actual cost
structure. Expense data for hospital-based HHAs can be affected by the
allocation of overhead costs over the entire institution.
We are proposing to derive eight major expense categories (Wages
and Salaries, Benefits, Contract Labor, Transportation, Professional
Liability Insurance (PLI), Fixed Capital, Movable Capital, and a
residual ``All Other'') from the 2016 Medicare HHA cost reports. Due to
its small weight, we are proposing to eliminate the cost category
`Postage' and include these expenses in the ``All Other (residual)''
cost weight. These major expense categories are based on those cost
centers that are reimbursable under the HHA PPS, specifically Skilled
Nursing Care, Physical Therapy, Occupational Therapy, Speech Pathology,
Medical Social Services, Home Health Aide, and Supplies. These are the
same cost centers that were used in the 2014 base payment rebasing (78
FR 72276), which are described in the Abt Associates Inc. June 2013,
Technical Paper, ``Analyses In Support of Rebasing and Updating
Medicare Home Health Payment Rates'' (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Analyses-in-Support-of-Rebasing-and-Updating-the-Medicare-Home-Health-Payment-Rates-Technical-Report.pdf). Total costs for the HHA PPS reimbursable
services reflect overhead allocation. We provide detail on the
calculations for each major expense category.
(1) Wages and Salaries: Wages and Salaries costs reflect direct
patient care wages and salaries costs as well as wages and salaries
costs associated with Plant Operations and Maintenance, Transportation,
and Administrative and General. Specifically, we are proposing to
calculate Wages and Salaries by summing costs from Worksheet A, column
1, lines 3 through 12 and subtracting line 5.03 (A&G Nonreimbursable
costs).
(2) Benefits: Benefits costs reflect direct patient care benefit
costs as well as benefit costs associated with Plant Operations and
Maintenance, Transportation, and Administrative and General.
Specifically, we are proposing to calculate Benefits by summing costs
from Worksheet A, column 2, lines 3 through 12 and subtracting line
5.03 (A&G Nonreimbursable costs).
(3) Direct Patient Care Contract Labor: Contract Labor costs
reflect direct patient care contract labor. Specifically, we are
proposing to calculate Contract Labor by summing costs from Worksheet
A, column 4, lines 6 through 11.
(4) Transportation: Transportation costs reflect direct patient
care costs as well as transportation costs associated with Capital
Expenses, Plant Operations and Maintenance, and Administrative and
General. Specifically, we are proposing to calculate Transportation by
summing costs from Worksheet A, column 3, lines 1 through 12 and
subtracting line 5.03 (A&G Nonreimbursable costs).
(5) Professional Liability Insurance: Professional Liability
Insurance reflects premiums, paid losses, and self-insurance costs.
Specifically we are proposing to calculate Professional Liability
Insurance by summing costs from Worksheet S2, lines 27.01, 27.02 and
27.03.
(6) Fixed Capital: Fixed Capital-related costs reflect the portion
of Medicare-allowable costs reported in ``Capital Related Buildings and
Fixtures'' (Worksheet A, column 5, line 1). We calculate this Medicare
allowable portion by first calculating a ratio for each provider that
reflects fixed capital costs as a percentage of HHA reimbursable
services. Specifically this ratio is calculated as the sum of costs
from Worksheet B, column 1, lines 6 through 12 divided by the sum of
costs from Worksheet B, column 1, line 1 minus lines 3 through 5. This
percentage is then applied to the sum of the costs from Worksheet A,
column 5, line 1.
[[Page 32362]]
(7) Movable Capital: Movable Capital-related costs reflect the
portion of Medicare-allowable costs reported in ``Capital Related
Moveable Equipment'' (Worksheet A, column 5, line 2). We calculate this
Medicare allowable portion by first calculating a ratio for each
provider that reflects movable capital costs as a percentage of HHA
reimbursable services. Specifically this ratio is calculated as the sum
of costs from Worksheet B, column 2, lines 6 through 12 divided by the
sum of costs from Worksheet B, column 2, line 2 minus lines 3 through
5. This percentage is then applied to the sum of the costs from
Worksheet A, column 5, line 2.
(8) All Other (residual): The ``All Other'' cost weight is a
residual, calculated by subtracting the major cost weight percentages
(Wages and Salaries, Benefits, Direct Patient Care Contract Labor,
Transportation, Professional Liability Insurance, Fixed Capital, and
Movable Capital) from 1.
As prescription drugs and DME are not payable under the HH PPS, we
continue to exclude those items from the home health market basket.
Totals within each of the major cost categories were edited to remove
reports where the data were deemed unreasonable (for example, when
total costs were not greater than zero). We then determined the
proportion of total Medicare allowable costs that each category
represents. For all of the major cost categories except the
``residual'' All Other cost weight, we then removed those providers
whose derived cost weights fall in the top and bottom five percent of
provider-specific cost weights to ensure the removal of outliers. After
the outliers were removed, we summed the costs for each category across
all remaining providers. We then divided this by the sum of total
Medicare allowable costs across all remaining providers to obtain a
cost weight for the proposed 2016-based home health market basket for
the given category.
Table 9 shows the major cost categories and their respective cost
weights as derived from the Medicare cost reports for this proposed
rule.
Table 9--Major Cost Categories as Derived From the Medicare Cost Reports
------------------------------------------------------------------------
Proposed 2016
Major cost categories 2010 based based
------------------------------------------------------------------------
Wages and Salaries (including allocated 66.3 65.1
direct patient care contract labor)....
Benefits (including allocated direct 12.2 10.9
patient care contract labor)...........
Transportation.......................... 2.5 2.6
Professional Liability Insurance 0.4 0.3
(Malpractice)..........................
Fixed Capital........................... 1.5 1.4
Moveable Capital........................ 0.6 0.6
``All Other'' residual.................. 16.5 19.0
------------------------------------------------------------------------
* Figures may not sum to 100.0 due to rounding.
The decrease in the wages and salaries cost weight of 1.2
percentage points and the decrease in the benefits cost weight of 1.3
percentage points is attributable to both employed compensation and
direct patient care contract labor costs as reported on the MCR data.
Our analysis of the MCR data shows that the decrease in the
compensation cost weight of 2.4 percentage points (calculated by
combining wages and salaries and benefits) from 2010 to 2016 occurred
among for-profit, nonprofit, and government providers and among
providers serving only rural beneficiaries, only urban beneficiaries,
or both rural and urban beneficiaries.
Over the 2010 to 2016 time period, the average number of FTEs per
provider decreased considerably. This corresponds with the HHA claims
analysis published on page 35279 of the CY 2018 proposed rule (https://www.thefederalregister.org/fdsys/pkg/FR-2017-07-28/pdf/2017-15825.pdf), which shows
that the number of visits per 60-day episode has decreased from 19.8
visits in 2010 to 17.9 visits in 2016 for Medicare PPS. Medicare visits
account for approximately 60 percent of total visits.
The direct patient care contract labor costs are contract labor
costs for skilled nursing, physical therapy, occupational therapy,
speech therapy, and home health aide cost centers. We allocated these
direct patient care contract labor costs to the Wages and Salaries and
Benefits cost categories based on each provider's relative proportions
of both employee wages and salaries and employee benefits costs. For
example, the direct patient care contract labor costs that are
allocated to wages and salaries is equal to: (A) The employee wages and
salaries costs as a percent of the sum of employee wages and salaries
costs and employee benefits costs times; and (B) direct patient care
contract labor costs. Nondirect patient care contract labor costs (such
as contract labor costs reported in the Administrative and General cost
center of the MCR) are captured in the ``All Other'' residual cost
weight and later disaggregated into more detail as described below.
This is a similar methodology that was implemented for the 2010-based
home health market basket.
We further divide the ``All Other'' residual cost weight estimated
from the 2016 Medicare cost report data into more detailed cost
categories. To divide this cost weight we are proposing to use the 2007
Benchmark I-O ``Use Tables/Before Redefinitions/Purchaser Value'' for
NAICS 621600, Home Health Agencies, published by the BEA. These data
are publicly available at http://www.bea.gov/industry/io_annual.htm.
The BEA Benchmark I-O data are generally scheduled for publication
every five years. The most recent data available at the time of
rebasing was for 2007. The 2007 Benchmark I-O data are derived from the
2007 Economic Census and are the building blocks for BEA's economic
accounts. Therefore, they represent the most comprehensive and complete
set of data on the economic processes or mechanisms by which output is
produced and distributed.\10\ Besides Benchmark I-O estimates, BEA also
produces Annual I-O estimates. While based on a similar methodology,
the Annual I-O estimates reflect less comprehensive and less detailed
data sources and are subject to revision when benchmark data become
available. Instead of using the less detailed Annual I-O data, we are
proposing to inflate the detailed 2007 Benchmark I-O data forward to
2016 by applying the annual price changes from the respective price
proxies to the appropriate market basket cost categories that are
obtained from the 2007 Benchmark I-O data. We repeated this practice
for each year. We then calculated the cost shares that each cost
[[Page 32363]]
category represents of the 2007 data inflated to 2016. These resulting
2016 cost shares were applied to the ``All Other'' residual cost weight
to obtain the detailed cost weights for the proposed 2016-based home
health market basket. For example, the cost for Operations and
Maintenance represents 8.0 percent of the sum of the ``All Other'' 2007
Benchmark I-O HHA Expenditures inflated to 2016. Therefore, the
Operations and Maintenance cost weight represents 8.0 percent of the
proposed 2016-based home health market basket's ``All Other'' cost
category (19.0 percent), yielding an Operations and Maintenance
proposed cost weight of 1.5 percent in the proposed 2016-based home
health market basket (0.080 x 19.0 percent = 1.5 percent). For the
2010-based home health market basket, we used the same methodology
utilizing the 2002 Benchmark I-O data (aged to 2010).
---------------------------------------------------------------------------
\10\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.
---------------------------------------------------------------------------
Using this methodology, we are proposing to derive nine detailed
cost categories from the proposed 2016-based home health market basket
``All Other'' residual cost weight (19.0 percent). These categories
are: (1) Operations and Maintenance; (2) Administrative Support; (3)
Financial Services; (4) Medical Supplies; (5) Rubber and Plastics; (6)
Telephone; (7) Professional Fees; (8) Other Products; and (9) Other
Services. The 2010-based home health market basket included a separate
cost category for Postage; however, due to its small weight for the
2016-based home health market basket, we propose to eliminate the
stand-alone cost category for Postage and include these expenses in the
Other Services cost category.
Table 10 lists the proposed 2016-based home health market basket
cost categories, cost weights, and price proxies.
Table 10--Cost Categories, Weights, and Price Proxies
in Proposed 2016-Based Home Health Market Basket
------------------------------------------------------------------------
Cost categories Weight Price proxy
------------------------------------------------------------------------
Compensation, including 76.1 .........................
allocated contract services'
labor.
Wages and Salaries, 65.1 Proposed Home Health
including allocated Blended Wages and
contract services' labor. Salaries Index (2016).
Benefits, including 10.9 Proposed Home Health
allocated contract Blended Benefits Index
services' labor. (2016).
Operations & Maintenance..... 1.5 CPI-U for Fuel and
utilities.
Professional Liability 0.3 CMS Physician
Insurance. Professional Liability
Insurance Index.
Administrative & General & 17.4 .........................
Other Expenses including
allocated contract services'
labor.
Administrative Support... 1.0 ECI for Total
compensation for Private
industry workers in
Office and
administrative support.
Financial Services....... 1.9 ECI for Total
compensation for Private
industry workers in
Financial activities.
Medical Supplies......... 0.9 PPI Commodity data for
Medical, surgical &
personal aid devices.
Rubber & Plastics........ 1.6 PPI Commodity data for
Rubber and plastic
products.
Telephone................ 0.7 CPI-U for Telephone
services.
Professional Fees........ 5.3 ECI for Total
compensation for Private
industry workers in
Professional and
related.
Other Products........... 2.8 PPI Commodity data for
Finished goods less
foods and energy.
Other Services........... 3.2 ECI for Total
compensation for Private
industry workers in
Service occupations.
Transportation............... 2.6 CPI-U for Transportation.
Capital-Related.............. 2.1 .........................
Fixed Capital............ 1.4 CPI-U for Owners'
equivalent rent of
residences.
Movable Capital.......... 0.6 PPI Commodity data for
Machinery and equipment.
----------------
Total.................... * 100.0 .........................
------------------------------------------------------------------------
* Figures may not sum due to rounding.
d. Proposed 2016-Based Home Health Market Basket Price Proxies
After we computed the CY 2016 cost category weights for the
proposed rebased home health market basket, we selected the most
appropriate wage and price indexes to proxy the rate of change for each
expenditure category. With the exception of the price index for
Professional Liability Insurance costs, the proposed price proxies are
based on Bureau of Labor Statistics (BLS) data and are grouped into one
of the following BLS categories:
Employment Cost Indexes--Employment Cost Indexes (ECIs)
measure the rate of change in employee wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. They are not affected by shifts in skill mix. ECIs
are superior to average hourly earnings as price proxies for input
price indexes for two reasons: (a) They measure pure price change; and
(b) they are available by occupational groups, not just by industry.
Consumer Price Indexes--Consumer Price Indexes (CPIs)
measure change in the prices of final goods and services bought by the
typical consumer. Consumer price indexes are used when the expenditure
is more similar to that of a purchase at the retail level rather than
at the wholesale level, or if no appropriate Producer Price Indexes
(PPIs) were available.
Producer Price Indexes--PPIs measures average changes in
prices received by domestic producers for their goods and services.
PPIs are used to measure price changes for goods sold in other than
retail markets. For example, a PPI for movable equipment is used rather
than a CPI for equipment. PPIs in some cases are preferable price
proxies for goods that HHAs purchase at wholesale levels. These fixed-
weight indexes are a measure of price change
[[Page 32364]]
at the producer or at the intermediate stage of production.
We evaluated the price proxies using the criteria of reliability,
timeliness, availability, and relevance. Reliability indicates that the
index is based on valid statistical methods and has low sampling
variability. Widely accepted statistical methods ensure that the data
were collected and aggregated in way that can be replicated. Low
sampling variability is desirable because it indicates that sample
reflects the typical members of the population. (Sampling variability
is variation that occurs by chance because a sample was surveyed rather
than the entire population.) Timeliness implies that the proxy is
published regularly, preferably at least once a quarter. The market
baskets are updated quarterly and therefore it is important the
underlying price proxies be up-to-date, reflecting the most recent data
available. We believe that using proxies that are published regularly
helps ensure that we are using the most recent data available to update
the market basket. We strive to use publications that are disseminated
frequently because we believe that this is an optimal way to stay
abreast of the most current data available. Availability means that the
proxy is publicly available. We prefer that our proxies are publicly
available because this will help ensure that our market basket updates
are as transparent to the public as possible. In addition, this enables
the public to be able to obtain the price proxy data on a regular
basis. Finally, relevance means that the proxy is applicable and
representative of the cost category weight to which it is applied. The
CPIs, PPIs, and ECIs selected by us to be proposed in this regulation
meet these criteria. Therefore, we believe that they continue to be the
best measure of price changes for the cost categories to which they
would be applied.
As part of the revising and rebasing of the home health market
basket, we are proposing to rebase the home health blended Wages and
Salaries index and the home health blended Benefits index. We propose
to use these blended indexes as price proxies for the Wages and
Salaries and the Benefits portions of the proposed 2016-based home
health market basket, as we did in the 2010-based home health market
basket. A more detailed discussion is provided below.
Wages and Salaries: For measuring price growth in the
2016-based home health market basket, we are proposing to apply six
price proxies to six occupational subcategories within the Wages and
Salaries component, which would reflect the HHA occupational mix. This
is the same approach used for the 2010-based index. We use a blended
wage proxy because there is not a published wage proxy specific to the
home health industry.
We are proposing to continue to use the National Industry-Specific
Occupational Employment and Wage estimates for North American
Industrial Classification System (NAICS) 621600, Home Health Care
Services, published by the BLS Office of Occupational Employment
Statistics (OES) as the data source for the cost shares of the home
health blended wage and benefits proxy. This is the same data source
that was used for the 2010-based HHA blended wage and benefit proxies;
however, we are proposing to use the May 2016 estimates in place of the
May 2010 estimates. Detailed information on the methodology for the
national industry-specific occupational employment and wage estimates
survey can be found at http://www.bls.gov/oes/current/oes_tec.htm.
The needed data on HHA expenditures for the six occupational
subcategories (Health-Related Professional and Technical, Non Health-
Related Professional and Technical, Management, Administrative, Health
and Social Assistance Service, and Other Service Workers) for the wages
and salaries component were tabulated from the May 2016 OES data for
NAICS 621600, Home Health Care Services. Table 11 compares the proposed
2016 occupational assignments to the 2010 occupational assignments of
the six CMS designated subcategories. If an OES occupational
classification does not exist in the 2010 or 2016 data we use ``n/a.''
Table 11--Proposed 2016 Occupational Assignments Compared to 2010
Occupational Assignments for CMS Home Health Wages and Salaries Blend
------------------------------------------------------------------------
2016 proposed occupational 2010 occupational groupings
groupings ------------------------------------
------------------------------------
Health-related Health-related
Group 1 professional Group 1 professional
and technical and technical
------------------------------------------------------------------------
n/a............... n/a............ 29-1021........... Dentists,
General.
29-1031........... Dietitians and 29-1031........... Dietitians and
Nutritionists. Nutritionists.
29-1051........... Pharmacists.... 29-1051........... Pharmacists.
29-1062........... Family and 29-1062........... Family and
General General
Practitioners. Practitioners.
29-1063........... Internists, 29-1063........... Internists,
General. General.
29-1065........... Pediatricians, n/a............... n/a.
General.
29-1066........... Psychiatrists.. n/a............... n/a.
29-1069........... Physicians and 29-1069........... Physicians and
Surgeons, All Surgeons, All
Other. Other.
29-1071........... Physician 29-1071........... Physician
Assistants. Assistants.
n/a............... n/a............ 29-1111........... Registered
Nurses.
29-1122........... Occupational 29-1122........... Occupational
Therapists. Therapists.
29-1123........... Physical 29-1123........... Physical
Therapists. Therapists.
29-1125........... Recreational 29-1125........... Recreational
Therapists. Therapists.
29-1126........... Respiratory 29-1126........... Respiratory
Therapists. Therapists.
29-1127........... Speech-Language 29-1127........... Speech-Language
Pathologists. Pathologists.
29-1129........... Therapists, All 29-1129........... Therapists, All
Other. Other.
29-1141........... Registered n/a............... n/a.
Nurses.
29-1171........... Nurse n/a............... n/a.
Practitioners.
29-1199........... Health 29-1199........... Health
Diagnosing and Diagnosing and
Treating Treating
Practitioners, Practitioners,
All Other. All Other.
------------------------------------------------------------------------
------------------------------------------------------------------------
[[Page 32365]]
------------------------------------------------------------------------
2016 proposed occupational groups 2010 occupational groupings
------------------------------------------------------------------------
Non health Non health
related related
Group 2 professional & Group 2 professional &
technical technical
------------------------------------------------------------------------
13-0000........... Business and 13-0000........... Business and
Financial Financial
Operations Operations
Occupations. Occupations.
15-0000........... Computer and 15-0000........... Computer and
Mathematical Mathematical
Occupations. Science
Occupations.
n/a............... n/a............ 17-0000........... Architecture
and
Engineering
Occupations.
19-0000........... Life, Physical, 19-0000........... Life, Physical,
and Social and Social
Science Science
Occupations. Occupations.
n/a............... n/a............ 23-0000........... Legal
Occupations.
25-0000........... Education, 25-0000........... Education,
Training, and Training, and
Library Library
Occupations. Occupations.
27-0000........... Arts, Design, 27-0000........... Arts, Design,
Entertainment, Entertainment,
Sports, and Sports, and
Media Media
Occupations. Occupations.
------------------------------------------------------------------------
Group 3 Management Group 3 Management
------------------------------------------------------------------------
11-0000........... Management 11-0000........... Management
Occupations. Occupations.
------------------------------------------------------------------------
Group 4 Administrative Group 4 Administrative
------------------------------------------------------------------------
43-0000........... Office and 43-0000........... Office and
Administrative Administrative
Support Support
Occupations. Occupations.
------------------------------------------------------------------------
Group 5 Health and Group 5 Health and
social social
assistance assistance
services services
------------------------------------------------------------------------
21-0000........... Community and 21-0000........... Community and
Social Service Social
Occupations. Services
Occupations.
29-2011........... Medical and 29-2011........... Medical and
Clinical Clinical
Laboratory Laboratory
Technologists. Technologists.
29-2012........... Medical and 29-2012........... Medical and
Clinical Clinical
Laboratory Laboratory
Technicians. Technicians.
29-2021........... Dental 29-2021........... Dental
Hygienists. Hygienists.
29-2032........... Diagnostic 29-2032........... Diagnostic
Medical Medical
Sonographers. Sonographers.
29-2034........... Radiologic 29-2034........... Radiologic
Technologists. Technologists
and
Technicians.
29-2041........... Emergency 29-2041........... Emergency
Medical Medical
Technicians Technicians
and Paramedics. and
Paramedics.
29-2051........... Dietetic 29-2051........... Dietetic
Technicians. Technicians.
29-2052........... Pharmacy 29-2052........... Pharmacy
Technicians. Technicians.
29-2053........... Psychiatric n/a............... n/a.
Technicians.
29-2054........... Respiratory 29-2054........... Respiratory
Therapy Therapy
Technicians. Technicians.
29-2055........... Surgical n/a............... n/a.
Technologists.
29-2061........... Licensed 29-2061........... Licensed
Practical and Practical and
Licensed Licensed
Vocational Vocational
Nurses. Nurses.
29-2071........... Medical Records 29-2071........... Medical Records
and Health and Health
Information Information
Technicians. Technicians.
29-2099........... Health 29-2099........... Health
Technologists Technologists
and and
Technicians, Technicians,
All Other. All Other.
n/a............... n/a............ 29-9012........... Occupational
Health and
Safety
Technicians.
29-9099........... Healthcare 29-9099........... Healthcare
Practitioners Practitioner
and Technical and Technical
Workers, All Workers, All
Other. Other.
31-0000........... Healthcare 31-0000........... Healthcare
Support Support
Occupations. Occupations.
------------------------------------------------------------------------
Group 6 Other service Group 6 Other service
workers workers
------------------------------------------------------------------------
33-0000........... Protective 33-0000........... Protective
Service Service
Occupations. Occupations.
35-0000........... Food 35-0000........... Food
Preparation Preparation
and Serving and Serving
Related Related
Occupations. Occupations.
37-0000........... Building and 37-0000........... Building and
Grounds Grounds
Cleaning and Cleaning and
Maintenance Maintenance
Occupations. Occupations.
39-0000........... Personal Care 39-0000........... Personal Care
and Service and Service
Occupations. Occupations.
41-0000........... Sales and 41-0000........... Sales and
Related Related
Occupations. Occupations.
47-0000........... Construction n/a............... n/a.
and Extraction
Occupations.
49-0000........... Installation, 49-0000........... Installation,
Maintenance, Maintenance,
and Repair and Repair
Occupations. Occupations.
51-0000........... Production 51-0000........... Production
Occupations. Occupations.
53-0000........... Transportation 53-0000........... Transportation
and Material and Material
Moving Moving
Occupations. Occupations.
------------------------------------------------------------------------
Total expenditures by occupation were calculated by taking the OES
number of employees multiplied by the OES annual average salary for
each subcategory, and then calculating the proportion of total wage
costs that each subcategory represents. The proportions listed in Table
12 represent the Wages and Salaries blend weights.
Table 12--Comparison of the Proposed 2016-Based Home Health Wages and Salaries Blend and the 2010-Based Home
Health Wages and Salaries Blend
----------------------------------------------------------------------------------------------------------------
Proposed 2016
Cost subcategory weight 2010 weight Price proxy BLS series ID
----------------------------------------------------------------------------------------------------------------
Health-Related Professional and 33.7 33.4 ECI for Wages and CIU1026220000000I.
Technical. salaries for All
Civilian workers
in Hospitals.
Non Health-Related Professional 2.3 2.3 ECI for Wages and CIU2025400000000I.
and Technical. salaries for
Private industry
workers in
Professional,
scientific, and
technical
services.
Management..................... 7.6 8.3 ECI for Wages and CIU2020000110000I.
salaries for
Private industry
workers in
Management,
business, and
financial.
[[Page 32366]]
Administrative................. 6.7 7.7 ECI for Wages and CIU2020000220000I.
salaries for
Private industry
workers in
Office and
administrative
support.
Health and Social Assistance 35.3 35.8 ECI for Wages and CIU1026200000000I.
Services. salaries for All
Civilian workers
in Health care
and social
assistance.
Other Service Occupations...... 14.4 12.6 ECI for Wages and CIU2020000300000I.
salaries for
Private industry
workers in
Service
occupations.
--------------------------------
Total *.................... 100.0 100.0
----------------------------------------------------------------------------------------------------------------
* Totals may not sum due to rounding.
A comparison of the yearly changes from CY 2016 to CY 2019 for the
2010-based home health Wages and Salaries blend and the proposed 2016-
based home health Wages and Salaries blend is shown in Table 13. The
annual increases in the two price proxies are the same when rounded to
one decimal place.
Table 13--Annual Growth in Proposed 2016 and 2010 Home Health Wages and Salaries Blend
----------------------------------------------------------------------------------------------------------------
2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Wage Blend 2016................................. 2.3 2.5 2.6 3.0
Wage Blend 2010................................. 2.3 2.5 2.6 3.0
----------------------------------------------------------------------------------------------------------------
Source: IHS Global Insight Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.
Benefits: For measuring Benefits price growth in the
proposed 2016-based home health market basket, we are proposing to
apply applicable price proxies to the six occupational subcategories
that are used for the Wages and Salaries blend. The proposed six
categories in Table 14 are the same as those in the 2010-based home
health market basket and include the same occupational mix as listed in
Table 14.
Table 14--Comparison of the Proposed 2016-Based Home Health Benefits Blend and 2010-Based Home Health Benefits
Blend
----------------------------------------------------------------------------------------------------------------
Proposed 2016
Cost category weight 2010 weight Price proxy
----------------------------------------------------------------------------------------------------------------
Health-Related Professional and Technical..... 33.9 33.5 ECI for Benefits for All
Civilian workers in Hospitals.
Non Health-Related Professional and Technical. 2.3 2.2 ECI for Benefits for Private
industry workers in
Professional, scientific, and
technical services.
Management.................................... 7.3 8.0 ECI for Benefits for Private
industry workers in Management,
business, and financial.
Administrative................................ 6.7 7.8 ECI for Benefits for Private
industry workers in Office and
administrative support.
Health and Social Assistance Services......... 35.5 35.9 ECI for Benefits for All
Civilian workers in Health care
and social assistance.
Other Service Workers......................... 14.2 12.5 ECI for Benefits for Private
industry workers in Service
occupations.
--------------------------------
Total *................................... 100.0 100.0
----------------------------------------------------------------------------------------------------------------
* Totals may not sum due to rounding.
There is no available data source that exists for benefit
expenditures by occupation for the home health industry. Thus, to
construct weights for the home health benefits blend we calculated the
ratio of benefits to wages and salaries for CY 2016 for the six ECI
series we are proposing to use in the blended `wages and salaries' and
`benefits' indexes. To derive the relevant benefits weight, we applied
the benefit-to-wage ratios to each of the six occupational
subcategories from the 2016 OES wage and salary weights, and
normalized. For example, the ratio of benefits to wages from the 2016
home health wages and salaries blend and the benefits blend for the
management category is 0.984. We apply this ratio to the 2016 OES
weight for wages and salaries for management, 7.6 percent, and then
normalize those weights relative to the other five benefit occupational
categories to obtain a benefit weight for management of 7.3 percent.
A comparison of the yearly changes from CY 2016 to CY 2019 for the
2010-based home health Benefits blend and the proposed 2016-based home
health Benefits blend is shown in Table 15. With the exception of a 0.1
percentage point difference in 2019, the annual increases in the two
price proxies are the same when rounded to one decimal place.
[[Page 32367]]
Table 15--Annual Growth in the Proposed 2016 Home Health Benefits Blend and the 2010 Home Health Benefits Blend
----------------------------------------------------------------------------------------------------------------
2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Benefits Blend 2016............................. 1.7 1.9 2.4 3.0
Benefits Blend 2010............................. 1.7 1.9 2.4 2.9
----------------------------------------------------------------------------------------------------------------
Source: IHS Global Insight Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.
Operations and Maintenance: We are proposing to use CPI
U.S. city average for Fuel and utilities (BLS series code
#CUUR0000SAH2) to measure price growth of this cost category. The same
proxy was used for the 2010-based home health market basket.
Professional Liability Insurance: We are proposing to use
the CMS Physician Professional Liability Insurance price index to
measure price growth of this cost category. The same proxy was used for
the 2010-based home health market basket.
To accurately reflect the price changes associated with physician
PLI, each year we collect PLI premium data for physicians from a
representative sample of commercial carriers and publically available
rate filings as maintained by each State's Association of Insurance
Commissioners. As we require for our other price proxies, the PLI price
proxy is intended to reflect the pure price change associated with this
particular cost category. Thus, the level of liability coverage is held
constant from year to year. To accomplish this, we obtain premium
information from a sample of commercial carriers for a fixed level of
coverage, currently $1 million per occurrence and a $3 million annual
limit. This information is collected for every State by physician
specialty and risk class. Finally, the State-level, physician-specialty
data are aggregated to compute a national total, using counts of
physicians by State and specialty as provided in the AMA publication,
Physician Characteristics and Distribution in the U.S.
Administrative and Support: We are proposing to use the
ECI for Total compensation for Private industry workers in Office and
administrative support (BLS series code #CIU2010000220000I) to measure
price growth of this cost category. The same proxy was used for the
2010-based home health market basket.
Financial Services: We are proposing to use the ECI for
Total compensation for Private industry workers in Financial activities
(BLS series code #CIU201520A000000I) to measure price growth of this
cost category. The same proxy was used for the 2010-based home health
market basket.
Medical Supplies: We are proposing to use the PPI
Commodity data for Miscellaneous products-Medical, surgical & personal
aid devices (BLS series code #WPU156) to measure price growth of this
cost category. The same proxy was used for the 2010-based home health
market basket.
Rubber and Plastics: We are proposing to use the PPI
Commodity data for Rubber and plastic products (BLS series code #WPU07)
to measure price growth of this cost category. The same proxy was used
for the 2010-based home health market basket.
Telephone: We are proposing to use CPI U.S. city average
for Telephone services (BLS series code #CUUR0000SEED) to measure price
growth of this cost category. The same proxy was used for the 2010-
based home health market basket.
Professional Fees: We are proposing to use the ECI for
Total compensation for Private industry workers in Professional and
related (BLS series code #CIS2010000120000I) to measure price growth of
this category. The same proxy was used for the 2010-based home health
market basket.
Other Products: We are proposing to use the PPI Commodity
data for Final demand-Finished goods less foods and energy (BLS series
code #WPUFD4131) to measure price growth of this category. The same
proxy was used for the 2010-based home health market basket.
Other Services: We are proposing to use the ECI for Total
compensation for Private industry workers in Service occupations (BLS
series code #CIU2010000300000I) to measure price growth of this
category. The same proxy was used for the 2010-based home health market
basket.
Transportation: We are proposing to use the CPI U.S. city
average for Transportation (BLS series code #CUUR0000SAT) to measure
price growth of this category. The same proxy was used for the 2010-
based home health market basket.
Fixed capital: We are proposing to use the CPI U.S. city
average for Owners' equivalent rent of residences (BLS series code
#CUUS0000SEHC) to measure price growth of this cost category. The same
proxy was used for the 2010-based home health market basket.
Movable Capital: We are proposing to use the PPI Commodity
data for Machinery and equipment (BLS series code #WPU11) to measure
price growth of this cost category. The same proxy was used for the
2010-based home health market basket.
e. Rebasing Results
A comparison of the yearly changes from CY 2014 to CY 2021 for the
2010-based home health market basket and the proposed 2016-based home
health market basket is shown in Table 16.
Table 16--Comparison of the 2010-Based Home Health Market Basket and the Proposed 2016-Based Home Health Market
Basket, Percent Change, 2014-2021
----------------------------------------------------------------------------------------------------------------
Proposed home Difference
Home health health market (proposed 2016-
market basket, basket, 2016- based less
2010-based based 2010-based)
----------------------------------------------------------------------------------------------------------------
Historical data:
CY 2014..................................................... 1.6 1.6 0.0
CY 2015..................................................... 1.6 1.5 -0.1
CY 2016..................................................... 2.0 2.0 0.0
CY 2017..................................................... 2.3 2.3 0.0
[[Page 32368]]
Average CYs 2014-2017................................... 1.9 1.9 0.0
Forecast:
CY 2018..................................................... 2.5 2.5 0.0
CY 2019..................................................... 2.8 2.8 0.0
CY 2020..................................................... 3.0 3.0 0.0
CY 2021..................................................... 3.0 3.0 0.0
Average CYs 2018-2021................................... 2.8 2.8 0.0
----------------------------------------------------------------------------------------------------------------
Source: IHS Global Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.
Table 16 shows that the forecasted rate of growth for CY 2019 for
the proposed 2016-based home health market basket is 2.8 percent, the
same rate of growth as estimated using the 2010-based home health
market basket; other forecasted years also show a similar increase.
Similarly, the historical estimates of the growth in the 2016-based and
2010-based home health market basket are the same except for CY 2015
where the 2010-based home health market basket is 0.1 percentage point
higher. We note that if more recent data are subsequently available
(for example, a more recent estimate of the market basket), we would
use such data to determine the market basket increases in the final
rule.
f. Labor-Related Share
Effective for CY 2019, we are proposing to revise the labor-related
share to reflect the proposed 2016-based home health market basket
Compensation (Wages and Salaries plus Benefits) cost weight. The
current labor-related share is based on the Compensation cost weight of
the 2010-based home health market basket. Based on the proposed 2016-
based home health market basket, the labor-related share would be 76.1
percent and the proposed non-labor-related share would be 23.9 percent.
The labor-related share for the 2010-based home health market basket
was 78.5 percent and the non-labor-related share was 21.5 percent. As
explained earlier, the decrease in the compensation cost weight of 2.4
percentage points is attributable to both employed compensation (wages
and salaries and benefits for employees) and direct patient care
contract labor costs as reported in the MCR data. Table 17 details the
components of the labor-related share for the 2010-based and proposed
2016-based home health market baskets.
Table 17--Labor-Related Share of Current and Proposed Home Health Market
Baskets
------------------------------------------------------------------------
2010-based Proposed 2016-
Cost category market basket based market
weight basket weight
------------------------------------------------------------------------
Wages and Salaries...................... 66.3 65.1
Employee Benefits....................... 12.2 11.0
Total Labor-Related..................... 78.5 76.1
Total Non Labor-Related................. 21.5 23.9
------------------------------------------------------------------------
We propose to implement the proposed revision to the labor-related
share of 76.1 percent in a budget neutral manner. This proposal would
be consistent with our policy of implementing the annual recalibration
of the case-mix weights and update of the home health wage index in a
budget neutral manner.
g. Multifactor Productivity
In the CY 2015 HHA PPS final rule (79 FR 38384 through 38384), we
finalized our methodology for calculating and applying the MFP
adjustment. As we explained in that rule, section 1895(b)(3)(B)(vi) of
the Act, requires that, in CY 2015 (and in subsequent calendar years,
except CY 2018 (under section 411(c) of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16,
2015)), the market basket percentage under the HHA prospective payment
system as described in section 1895(b)(3)(B) of the Act be annually
adjusted by changes in economy-wide productivity. Section
1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment to
be equal to the 10-year moving average of change in annual economy-wide
private nonfarm business multifactor productivity (MFP) (as projected
by the Secretary for the 10-year period ending with the applicable
fiscal year, calendar year, cost reporting period, or other annual
period) (the ``MFP adjustment''). The Bureau of Labor Statistics (BLS)
is the agency that publishes the official measure of private nonfarm
business MFP. Please see http://www.bls.gov/mfp, to obtain the BLS
historical published MFP data.
Based on IHS Global Inc.'s (IGI's) first quarter 2018 forecast with
history through the fourth quarter of 2017, the projected MFP
adjustment (the 10-year moving average of MFP for the period ending
December 31, 2019) for CY 2019 is 0.7 percent. IGI is a nationally
recognized economic and financial forecasting firm that contracts with
CMS to forecast the components of the market baskets. We note that if
more recent data are subsequently available (for example, a more recent
estimate of the MFP adjustment), we would use such data to determine
the MFP adjustment in the final rule.
[[Page 32369]]
2. Proposed CY 2019 Market Basket Update for HHAs
Using IGI's first quarter 2018 forecast, the MFP adjustment for CY
2019 is projected to be 0.7 percent. In accordance with section
1895(b)(3)(B)(iii) of the Act, we propose to base the CY 2019 market
basket update, which is used to determine the applicable percentage
increase for HHA payments, on the most recent estimate of the proposed
2016-based home health market basket. Based on IGI's first quarter 2018
forecast with history through the fourth quarter of 2017, the projected
increase of the proposed 2016-based home health market basket for CY
2019 is 2.8 percent. We propose to then reduce this percentage increase
by the current estimate of the MFP adjustment for CY 2019 of 0.7
percentage point in accordance with 1895(b)(3)(B)(vi) of the Act.
Therefore, the current estimate of the CY 2019 HHA payment update is
2.1 percent (2.8 percent market basket update, less 0.7 percentage
point MFP adjustment). Furthermore, we note that if more recent data
are subsequently available (for example, a more recent estimate of the
market basket and MFP adjustment), we would use such data to determine
the CY 2019 market basket update and MFP adjustment in the final rule.
Section 1895(b)(3)(B)(v) of the Act requires that the home health
update be decreased by 2 percentage points for those HHAs that do not
submit quality data as required by the Secretary. For HHAs that do not
submit the required quality data for CY 2019, the home health payment
update will be 0.1 percent (2.1 percent minus 2 percentage points).
3. CY 2019 Home Health Wage Index
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the
Secretary to provide appropriate adjustments to the proportion of the
payment amount under the HH PPS that account for area wage differences,
using adjustment factors that reflect the relative level of wages and
wage-related costs applicable to the furnishing of HH services. Since
the inception of the HH PPS, we have used inpatient hospital wage data
in developing a wage index to be applied to HH payments. We propose to
continue this practice for CY 2019, as we continue to believe that, in
the absence of HH-specific wage data that accounts for area
differences, using inpatient hospital wage data is appropriate and
reasonable for the HH PPS. Specifically, we propose to continue to use
the pre-floor, pre-reclassified hospital wage index as the wage
adjustment to the labor portion of the HH PPS rates. For CY 2019, the
updated wage data are for hospital cost reporting periods beginning on
or after October 1, 2014, and before October 1, 2015 (FY 2015 cost
report data). We apply the appropriate wage index value to the labor
portion of the HH PPS rates based on the site of service for the
beneficiary (defined by section 1861(m) of the Act as the beneficiary's
place of residence).
To address those geographic areas in which there are no inpatient
hospitals, and thus, no hospital wage data on which to base the
calculation of the CY 2019 HH PPS wage index, we propose to continue to
use the same methodology discussed in the CY 2007 HH PPS final rule (71
FR 65884) to address those geographic areas in which there are no
inpatient hospitals. For rural areas that do not have inpatient
hospitals, we propose to use the average wage index from all contiguous
Core Based Statistical Areas (CBSAs) as a reasonable proxy. Currently,
the only rural area without a hospital from which hospital wage data
could be derived is Puerto Rico. However, for rural Puerto Rico, we do
not apply this methodology due to the distinct economic circumstances
that exist there (for example, due to the close proximity to one
another of almost all of Puerto Rico's various urban and non-urban
areas, this methodology would produce a wage index for rural Puerto
Rico that is higher than that in half of its urban areas). Instead, we
propose to continue to use the most recent wage index previously
available for that area. For urban areas without inpatient hospitals,
we use the average wage index of all urban areas within the state as a
reasonable proxy for the wage index for that CBSA. For CY 2019, the
only urban area without inpatient hospital wage data is Hinesville, GA
(CBSA 25980).
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing
revisions to the delineations of MSAs, Micropolitan Statistical Areas,
and CBSAs, and guidance on uses of the delineation of these areas. In
the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we adopted
the OMB's new area delineations using a 1-year transition.
On August 15, 2017, OMB issued Bulletin No. 17-01 in which it
announced that one Micropolitan Statistical Area, Twin Falls, Idaho,
now qualifies as a Metropolitan Statistical Area. The new CBSA (46300)
comprises the principal city of Twin Falls, Idaho in Jerome County,
Idaho and Twin Falls County, Idaho. The CY 2019 HH PPS wage index value
for CBSA 46300, Twin Falls, Idaho, will be 0.8335. Bulletin No. 17-01
is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.\11\
---------------------------------------------------------------------------
\11\ ``Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN
NO. 17-01. August 15, 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf.
---------------------------------------------------------------------------
The most recent OMB Bulletin (No. 18-03) was published on April 10,
2018 and is available at https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf.\12\ The revisions contained
in OMB Bulletin No. 18-03 have no impact on the geographic area
delineations that are used to wage adjust HH PPS payments.
---------------------------------------------------------------------------
\12\ ``Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN
NO. 18-03. April 10, 2018. https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf.
---------------------------------------------------------------------------
The CY 2019 wage index is available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices.html.
4. CY 2019 Annual Payment Update
a. Background
The Medicare HH PPS has been in effect since October 1, 2000. As
set forth in the July 3, 2000 final rule (65 FR 41128), the base unit
of payment under the Medicare HH PPS is a national, standardized 60-day
episode payment rate. As set forth in Sec. 484.220, we adjust the
national, standardized 60-day episode payment rate by a case-mix
relative weight and a wage index value based on the site of service for
the beneficiary.
To provide appropriate adjustments to the proportion of the payment
amount under the HH PPS to account for area wage differences, we apply
the appropriate wage index value to the labor portion of the HH PPS
rates. As discussed in section III.C.1 of this proposed rule, based on
the proposed 2016-based home health market basket, the proposed labor-
related share would be 76.1 percent and the proposed non-labor-related
share would be 23.9 percent for CY 2019. The CY 2019 HH PPS rates use
the same case-mix methodology as set forth in the CY 2008 HH PPS final
rule with comment period (72 FR 49762) and will be adjusted as
described in section III.B of this proposed rule. The following are the
steps we take to compute the case-mix
[[Page 32370]]
and wage-adjusted 60-day episode rate for CY 2019:
Multiply the national 60-day episode rate by the patient's
applicable case-mix weight.
Divide the case-mix adjusted amount into a labor (76.1
percent) and a non-labor portion (23.9 percent).
Multiply the labor portion by the applicable wage index
based on the site of service of the beneficiary.
Add the wage-adjusted portion to the non-labor portion,
yielding the case-mix and wage adjusted 60-day episode rate, subject to
any additional applicable adjustments.
In accordance with section 1895(b)(3)(B) of the Act, we propose the
annual update of the HH PPS rates. Section 484.225 sets forth the
specific annual percentage update methodology. In accordance with Sec.
484.225(i), for a HHA that does not submit HH quality data, as
specified by the Secretary, the unadjusted national prospective 60-day
episode rate is equal to the rate for the previous calendar year
increased by the applicable HH market basket index amount minus 2
percentage points. Any reduction of the percentage change would apply
only to the calendar year involved and would not be considered in
computing the prospective payment amount for a subsequent calendar
year.
Medicare pays the national, standardized 60-day case-mix and wage-
adjusted episode payment on a split percentage payment approach. The
split percentage payment approach includes an initial percentage
payment and a final percentage payment as set forth in Sec.
484.205(b)(1) and (b)(2). We may base the initial percentage payment on
the submission of a request for anticipated payment (RAP) and the final
percentage payment on the submission of the claim for the episode, as
discussed in Sec. 409.43. The claim for the episode that the HHA
submits for the final percentage payment determines the total payment
amount for the episode and whether we make an applicable adjustment to
the 60-day case-mix and wage-adjusted episode payment. The end date of
the 60-day episode as reported on the claim determines which calendar
year rates Medicare will use to pay the claim.
We may also adjust the 60-day case-mix and wage-adjusted episode
payment based on the information submitted on the claim to reflect the
following:
A low-utilization payment adjustment (LUPA) is provided on
a per-visit basis as set forth in Sec. Sec. 484.205(c) and 484.230.
A partial episode payment (PEP) adjustment as set forth in
Sec. Sec. 484.205(d) and 484.235.
An outlier payment as set forth in Sec. Sec. 484.205(e)
and 484.240.
b. CY 2019 National, Standardized 60-Day Episode Payment Rate
Section 1895(b)(3)(A)(i) of the Act requires that the 60-day
episode base rate and other applicable amounts be standardized in a
manner that eliminates the effects of variations in relative case-mix
and area wage adjustments among different home health agencies in a
budget neutral manner. To determine the CY 2019 national, standardized
60-day episode payment rate, we apply a wage index budget neutrality
factor and a case-mix budget neutrality factor described in section
III.B of this proposed rule; and the home health payment update
percentage discussed in section III.C.2 of this proposed rule.
To calculate the wage index budget neutrality factor, we simulated
total payments for non-LUPA episodes using the CY 2019 wage index
(including the application of the proposed labor-related share of 76.1
percent and the proposed non-labor-related share of 23.9 percent) and
compared it to our simulation of total payments for non-LUPA episodes
using the CY 2018 wage index and CY 2018 (including the application of
the current labor-related share of 78.535 percent and the non-labor-
related of 21.465). By dividing the total payments for non-LUPA
episodes using the CY 2019 wage index by the total payments for non-
LUPA episodes using the CY 2018 wage index, we obtain a wage index
budget neutrality factor of 0.9991. We would apply the wage index
budget neutrality factor of 0.9991 to the calculation of the CY 2019
national, standardized 60-day episode payment rate.
As discussed in section III.B of this proposed rule, to ensure the
changes to the case-mix weights are implemented in a budget neutral
manner, we propose to apply a case-mix weight budget neutrality factor
to the CY 2019 national, standardized 60-day episode payment rate. The
case-mix weight budget neutrality factor is calculated as the ratio of
total payments when CY 2019 case-mix weights are applied to CY 2017
utilization (claims) data to total payments when CY 2018 case-mix
weights are applied to CY 2017 utilization data. The case-mix budget
neutrality factor for CY 2019 is 1.0163 as described in section III.B
of this proposed rule.
Next, we would update the payment rates by the CY 2019 home health
payment update percentage of 2.1 percent as described in section
III.C.2 of this proposed rule. The CY 2019 national, standardized 60-
day episode payment rate is calculated in Table 18.
Table 18--CY 2019 60-Day National, Standardized 60-Day Episode Payment Amount
----------------------------------------------------------------------------------------------------------------
CY 2019
Wage index Case-mix National,
CY 2018 national, standardized 60-day budget weights budget CY 2019 HH standardized 60-
episode payment neutrality neutrality payment update day episode
factor factor payment
----------------------------------------------------------------------------------------------------------------
$3,039.64................................... x 0.9991 x 1.0163 x 1.021 $3,151.22
----------------------------------------------------------------------------------------------------------------
The CY 2019 national, standardized 60-day episode payment rate for
an HHA that does not submit the required quality data is updated by the
CY 2019 home health payment update of 2.1 percent minus 2 percentage
points and is shown in Table 19.
[[Page 32371]]
Table 19--CY 2019 National, Standardized 60-Day Episode Payment Amount for HHAs That Do Not Submit the Quality
Data
----------------------------------------------------------------------------------------------------------------
CY 2019 HH CY 2019
Wage index Case-mix payment update National,
CY 2018 national, standardized 60-day budget weights budget minus 2 standardized 60-
episode payment neutrality neutrality percentage day episode
factor factor points payment
----------------------------------------------------------------------------------------------------------------
$3,039.64................................... x 0.9991 x 1.0163 x 1.001 $3,089.49
----------------------------------------------------------------------------------------------------------------
c. CY 2019 National Per-Visit Rates
The national per-visit rates are used to pay LUPAs (episodes with
four or fewer visits) and are also used to compute imputed costs in
outlier calculations. The per-visit rates are paid by type of visit or
HH discipline. The six HH disciplines are as follows:
Home health aide (HH aide).
Medical Social Services (MSS).
Occupational therapy (OT).
Physical therapy (PT).
Skilled nursing (SN).
Speech-language pathology (SLP).
To calculate the CY 2019 national per-visit rates, we started with
the CY 2018 national per-visit rates. Then we applied a wage index
budget neutrality factor to ensure budget neutrality for LUPA per-visit
payments. We calculated the wage index budget neutrality factor by
simulating total payments for LUPA episodes using the CY 2019 wage
index and comparing it to simulated total payments for LUPA episodes
using the CY 2018 wage index. By dividing the total payments for LUPA
episodes using the CY 2019 wage index by the total payments for LUPA
episodes using the CY 2018 wage index, we obtained a wage index budget
neutrality factor of 1.0000. We apply the wage index budget neutrality
factor of 1.0000 in order to calculate the CY 2019 national per-visit
rates.
The LUPA per-visit rates are not calculated using case-mix weights.
Therefore, no case-mix weights budget neutrality factor is needed to
ensure budget neutrality for LUPA payments. Lastly, the per-visit rates
for each discipline are updated by the CY 2019 home health payment
update percentage of 2.1 percent. The national per-visit rates are
adjusted by the wage index based on the site of service of the
beneficiary. The per-visit payments for LUPAs are separate from the
LUPA add-on payment amount, which is paid for episodes that occur as
the only episode or initial episode in a sequence of adjacent episodes.
The CY 2019 national per-visit rates for HHAs that submit the required
quality data are updated by the CY 2019 HH payment update percentage of
2.1 percent and are shown in Table 20.
Table 20--CY 2019 National Per-Visit Payment Amounts for HHAs That Do Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Wage index
CY 2018 per- budget CY 2019 HH CY 2019 per-
HH Discipline visit payment neutrality payment update visit payment
factor
----------------------------------------------------------------------------------------------------------------
Home Health Aide............................ $64.94 x 1.0000 x 1.021 $66.30
Medical Social Services..................... 229.86 x 1.0000 x 1.021 234.69
Occupational Therapy........................ 157.83 x 1.0000 x 1.021 161.14
Physical Therapy............................ 156.76 x 1.0000 x 1.021 160.05
Skilled Nursing............................. 143.40 x 1.0000 x 1.021 146.41
Speech-Language Pathology................... 170.38 x 1.0000 x 1.021 173.96
----------------------------------------------------------------------------------------------------------------
The CY 2019 per-visit payment rates for HHAs that do not submit the
required quality data are updated by the CY 2019 HH payment update
percentage of 2.1 percent minus 2 percentage points and are shown in
Table 21.
Table 21--CY 2019 National Per-Visit Payment Amounts for HHAs That Do Not Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
CY 2019 HH
Wage index payment update
HH Discipline CY 2018 per- budget minus 2 CY 2019 per-
visit rates neutrality percentage visit rates
factor points
----------------------------------------------------------------------------------------------------------------
Home Health Aide............................ $64.94 x 1.0000 x 1.001 $65.00
Medical Social Services..................... 229.86 x 1.0000 x 1.001 230.09
Occupational Therapy........................ 157.83 x 1.0000 x 1.001 157.99
Physical Therapy............................ 156.76 x 1.0000 x 1.001 156.92
Skilled Nursing............................. 143.40 x 1.0000 x 1.001 143.54
Speech-Language Pathology................... 170.38 x 1.0000 x 1.001 170.55
----------------------------------------------------------------------------------------------------------------
[[Page 32372]]
d. Low-Utilization Payment Adjustment (LUPA) Add-On Factors
LUPA episodes that occur as the only episode or as an initial
episode in a sequence of adjacent episodes are adjusted by applying an
additional amount to the LUPA payment before adjusting for area wage
differences. In the CY 2014 HH PPS final rule (78 FR 72305), we changed
the methodology for calculating the LUPA add-on amount by finalizing
the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and
1.6266 for SLP. We multiply the per-visit payment amount for the first
SN, PT, or SLP visit in LUPA episodes that occur as the only episode or
an initial episode in a sequence of adjacent episodes by the
appropriate factor to determine the LUPA add-on payment amount. For
example, in the case of HHAs that do submit the required quality data,
for LUPA episodes that occur as the only episode or an initial episode
in a sequence of adjacent episodes, if the first skilled visit is SN,
the payment for that visit will be $270.14 (1.8451 multiplied by
$146.41), subject to area wage adjustment.
e. CY 2019 Non-Routine Medical Supply (NRS) Payment Rates
All medical supplies (routine and nonroutine) must be provided by
the HHA while the patient is under a home health plan of care. Examples
of supplies that can be considered non-routine include dressings for
wound care, I.V. supplies, ostomy supplies, catheters, and catheter
supplies. Payments for NRS are computed by multiplying the relative
weight for a particular severity level by the NRS conversion factor. To
determine the CY 2019 NRS conversion factor, we updated the CY 2018 NRS
conversion factor ($53.03) by the CY 2019 home health payment update
percentage of 2.1 percent. We did not apply a standardization factor as
the NRS payment amount calculated from the conversion factor is not
wage or case-mix adjusted when the final claim payment amount is
computed. The proposed NRS conversion factor for CY 2019 is shown in
Table 22.
Table 22--CY 2019 NRS Conversion Factor for HHAs That Do Submit the
Required Quality Data
------------------------------------------------------------------------
CY 2019 NRS
CY 2018 NRS conversion factor CY 2019 HH conversion
payment update factor
------------------------------------------------------------------------
$53.03................................ x 1.021 $54.14
------------------------------------------------------------------------
Using the CY 2019 NRS conversion factor, the payment amounts for
the six severity levels are shown in Table 23.
Table 23--CY 2019 NRS Payment Amounts for HHAs That Do Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Points CY 2019 NRS
Severity level (scoring) Relative weight payment amounts
----------------------------------------------------------------------------------------------------------------
1............................................................ 0 0.2698 $ 14.61
2............................................................ 1 to 14 0.9742 52.74
3............................................................ 15 to 27 2.6712 144.62
4............................................................ 28 to 48 3.9686 214.86
5............................................................ 49 to 98 6.1198 331.33
6............................................................ 99+ 10.5254 569.85
----------------------------------------------------------------------------------------------------------------
For HHAs that do not submit the required quality data, we updated
the CY 2018 NRS conversion factor ($53.03) by the CY 2019 home health
payment update percentage of 2.1 percent minus 2 percentage points. The
proposed CY 2019 NRS conversion factor for HHAs that do not submit
quality data is shown in Table 24.
Table 24--CY 2019 NRS Conversion Factor for HHAs That Do Not Submit the
Required Quality Data
------------------------------------------------------------------------
CY 2019 HH
payment update
percentage CY 2019 NRS
CY 2018 NRS conversion factor minus 2 conversion
percentage factor
points
------------------------------------------------------------------------
$53.03................................ x 1.001 $53.08
------------------------------------------------------------------------
The payment amounts for the various severity levels based on the
updated conversion factor for HHAs that do not submit quality data are
calculated in Table 25.
[[Page 32373]]
Table 25--CY 2019 NRS Payment Amounts for HHAs That Do Not Submit the Required Quality Data
----------------------------------------------------------------------------------------------------------------
Points CY 2019 NRS
Severity level (scoring) Relative weight payment amounts
----------------------------------------------------------------------------------------------------------------
1............................................................ 0 0.2698 $ 14.32
2............................................................ 1 to 14 0.9742 51.71
3............................................................ 15 to 27 2.6712 141.79
4............................................................ 28 to 48 3.9686 210.65
5............................................................ 49 to 98 6.1198 324.84
6............................................................ 99+ 10.5254 558.69
----------------------------------------------------------------------------------------------------------------
D. Proposed Rural Add-On Payments for CYs 2019 Through 2022
1. Background
Section 421(a) of the MMA required, for HH services furnished in a
rural areas (as defined in section 1886(d)(2)(D) of the Act), for
episodes or visits ending on or after April 1, 2004, and before April
1, 2005, that the Secretary increase the payment amount that otherwise
would have been made under section 1895 of the Act for the services by
5 percent.
Section 5201 of the DRA amended section 421(a) of the MMA. The
amended section 421(a) of the MMA required, for HH services furnished
in a rural area (as defined in section 1886(d)(2)(D) of the Act), on or
after January 1, 2006, and before January 1, 2007, that the Secretary
increase the payment amount otherwise made under section 1895 of the
Act for those services by 5 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a)
of the MMA to provide an increase of 3 percent of the payment amount
otherwise made under section 1895 of the Act for HH services furnished
in a rural area (as defined in section 1886(d)(2)(D) of the Act), for
episodes and visits ending on or after April 1, 2010, and before
January 1, 2016.
Section 210 of the MACRA amended section 421(a) of the MMA to
extend the rural add-on by providing an increase of 3 percent of the
payment amount otherwise made under section 1895 of the Act for HH
services provided in a rural area (as defined in section 1886(d)(2)(D)
of the Act), for episodes and visits ending before January 1, 2018.
Section 50208(a) of the Bipartisan Budget Act of 2018 amended
section 421(a) of the MMA to extend the rural add-on by providing an
increase of 3 percent of the payment amount otherwise made under
section 1895 of the Act for HH services provided in a rural area (as
defined in section 1886(d)(2)(D) of the Act), for episodes and visits
ending before January 1, 2019. This extension of the rural add-on
payments was implemented as described in CMS Transmittal 2047 published
on March 20, 2018.
2. Proposed Rural Add-On Payments for CYs 2019 Through 2022
Section 50208(a)(1)(D) of the BBA of 2018 adds a new subsection (b)
to section 421 of the MMA to provide rural add-on payments for episodes
and visits ending during CYs 2019 through 2022 . It also mandates
implementation of a new methodology for applying those payments. Unlike
previous rural add-ons, which were applied to all rural areas
uniformly, the extension provides varying add-on amounts depending on
the rural county (or equivalent area) classification by classifying
each rural county (or equivalent area) into one of three distinct
categories.
Specifically, section 421(b)(1) of the MMA, as amended by section
50208 of the BBA of 2018, provides that rural counties (or equivalent
areas) would be placed into one of three categories for purposes of HH
rural add-on payments: (1) Rural counties and equivalent areas in the
highest quartile of all counties and equivalent areas based on the
number of Medicare home health episodes furnished per 100 individuals
who are entitled to, or enrolled for, benefits under part A of Medicare
or enrolled for benefits under part B of Medicare only, but not
enrolled in a Medicare Advantage plan under part C of Medicare, as
provided in section 421(b)(1)(A) of the MMA (the ``High utilization''
category); (2) rural counties and equivalent areas with a population
density of 6 individuals or fewer per square mile of land area and are
not included in the category provided in section 421(b)(1)(A) of the
MMA, as provided in section 421(b)(1)(B) of the MMA (the Low population
density'' category); and (3) rural counties and equivalent areas not in
the categories provided in either sections 421(b)(1)(A) or 421(b)(1)(B)
of the MMA, as provided in section 421(b)(1)(C) of the MMA (the ``All
other'' category). The list of counties and equivalent areas used in
our analysis is based on the CY 2015 HH PPS wage index file, which
includes the names of the constituent counties for each rural and urban
area designation. We used the 2015 HH PPS wage index file as the basis
for our analysis because the 2015 HH PPS wage index file already
included SSA state and county codes not normally included on the HH PPS
wage index files, but were included in the 2015 HH PPS wage index file
due to the transition to new OMB geographic area delineations that
year. The CY 2015 HH PPS wage index file is available for download at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1611-F.html. This file includes 3,246 counties and
equivalent areas and their urban and rural status and uses the OMB's
geographic area delineations, as described in section III.C.3 of this
proposed rule. We updated the information contained in this file to
include any revisions to the geographic area delineations as published
by the OMB in their publicly available bulletins that would reflect a
change in urban and rural status. The states, the District of Columbia,
and the U.S. territories of Guam, Puerto Rico, and the U.S. Virgin
Islands are included in the analysis file containing 3,246 counties and
equivalent areas. Of the 3,246 total counties and equivalent areas that
were used in our analysis, 2,006 of these are considered rural for
purposes of determining HH rural add-on payments. We identify
equivalent areas based on the definition of equivalent entities as
defined by the OMB in their most recent bulletin (No. 18-03) available
at https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf.\13\ We consider boroughs and a municipality in
Alaska, parishes in Louisiana, municipios in Puerto Rico, and
independent cities in
[[Page 32374]]
Maryland, Missouri, Nevada, and Virginia as equivalent areas.
---------------------------------------------------------------------------
\13\ ``Revised Delineations of Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas, and
Guidance on Uses of the Delineations of These Areas''. OMB BULLETIN
NO. 18-03. April 10, 2018. https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf.
---------------------------------------------------------------------------
Under section 421(b)(1)(A) of the MMA, one category of rural
counties and equivalent areas for purposes of the HH rural add-on
payment is a category comprised of rural counties or equivalent areas
that are in the highest quartile of all counties or equivalent areas
based on the number of Medicare home health episodes furnished per 100
Medicare beneficiaries. Section 421(b)(2)(B)(i) of the MMA requires the
use of data from 2015 to determine which counties or equivalent areas
are in the highest quartile of home health utilization for the category
described under section 421(b)(1)(A) of the MMA, that is, the ``High
utilization'' category. Section 421(b)(2)(B)(ii) of the MMA requires
that data from the territories are to be excluded in determining which
counties or equivalent areas are in the highest quartile of home health
utilization and requires that the territories be excluded from the
category described by section 421(b)(1)(A) of the MMA. Under section
421(b)(2)(B)(iii) of the MMA, the Secretary may exclude data from
counties or equivalent areas in rural areas with a low volume of home
health episodes in determining which counties or equivalent areas are
in the highest quartile of home health utilization. If data is excluded
for a county or equivalent area, section 421(b)(2)(B)(iii) of the MMA
requires that the county or equivalent area be excluded from the
category described by section 421(b)(1)(A) of the MMA (the ``High
utilization'' category).
We used CY 2015 claims data and 2015 data from the Medicare
Beneficiary Summary File to classify rural counties and equivalent
areas into the ``High utilization'' category. We propose to classify a
rural county or equivalent area into this category if the county or
equivalent area is in the highest quartile (top 25th percentile) of all
(urban and rural) counties and equivalent areas based on the ratio of
Medicare home health episodes furnished per 100 Medicare enrollees. The
Medicare Beneficiary Summary File contained information on the Social
Security Administration (SSA) state and county code of the
beneficiary's mailing address and information on enrollment in Medicare
Part A, B, and C during 2015. The claims data and information from the
Medicare Beneficiary Summary File were pulled from the Chronic
Condition Warehouse Virtual Research Data Center during December 2017.
We used the claims data to determine how many home health episodes
(excluding Requests for Anticipated Payments (RAPs) and zero payment
episodes) occurred in each state and county or equivalent area. We
assigned each home health episode to the state and county code of the
beneficiary's mailing address. As stipulated by section
421(b)(2)(B)(ii) of the MMA, we excluded any data from the territories
of Guam, Puerto Rico, and the U.S. Virgin Islands for determining which
rural counties and equivalent areas belong in the ``High utilization''
category. We note that the territories of American Samoa and the
Northern Mariana Islands were not included in the CY 2015 HH PPS wage
index file to identify counties or equivalent areas for these
territories so no data from these territories were included in
determining the ``High utilization'' category. As we are not aware of
any Medicare home health services being furnished in these two
territories in recent years, we will address any application of home
health rural add-on payments for these territories in the future should
Medicare home health services be furnished in them. Therefore, counties
and equivalent areas in the territories of American Samoa, Guam, the
Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands are
not included in the ``High utilization'' category, as required by
section 421(b)(2)(B)(ii) of the MMA. In addition, under the authority
granted to the Secretary (by section 421(b)(2)(B)(iii) of the MMA) to
exclude data from counties or equivalent areas in rural areas with a
low volume of home health episodes, we excluded data from rural
counties and equivalent areas that had 10 or fewer episodes during 2015
for determining which counties and equivalent areas belong in the
``High utilization'' category. We believe that using a threshold of 10
or fewer episodes is a reasonable threshold for defining low volume, in
accordance with section 421(b)(2)(B)(iii) of the MMA. After excluding
data from (1) the territories of Guam, Puerto Rico, and the U.S. Virgin
Islands and (2) counties and equivalent areas that had 10 or fewer
episodes during 2015, we determined the number of home health episodes
furnished per 100 enrollees for the remaining counties and equivalent
areas. We determined that the counties or equivalent areas in the
highest quartile have a ratio of episodes to beneficiaries that is at
or above 17.72487. The highest quartile consisted of 778 counties or
equivalent areas. Of those 778 counties or equivalent areas, 510 are
rural and, therefore, we propose to classify these 510 rural counties
or equivalent areas into the ``High utilization'' category.
Under section 421(b)(1)(B) of the MMA, another category of rural
counties and equivalent areas for purposes of the HH rural add-on
payment is a category comprised of rural counties or equivalent areas
with a population density of 6 individuals or fewer per square mile of
land area and that are not included in the ``High utilization''
category. Section 421(b)(2)(C) of the MMA requires that data from the
2010 decennial Census be used for purposes of determining population
density with respect to the category provided under section
421(b)(1)(B) of the MMA, that is, the ``Low population density''
category.
We used 2010 Census data gathered from the tables provided at:
https://factfinder.census.gov/bkmk/table/1.0/en/DEC/10_SF1/GCTPH1.US05PR and https://www.census.gov/data/tables/time-series/dec/cph-series/cph-t/cph-t-8.html to determine which counties and
equivalent areas have a population density of six individuals or fewer
per square mile of land area.\14\ \15\ In examining the rural counties
and equivalent areas that were not already classified into the ``High
utilization'' category, we identified each rural county or equivalent
area that had a population density of six individuals or fewer per
square mile of land area. As a result of that analysis, we determined
there are 334 rural counties or equivalent areas that have a population
density of six individuals or fewer per square mile of land area and
that are not already classified into the ``High utilization'' category.
We propose to classify 334 rural counties or equivalent areas into the
``Low population density'' category.
---------------------------------------------------------------------------
\14\ ``Population, Housing Units, Area, and Density: 2010--
United States--County by State; and for Puerto Rico 2010 Census
Summary File 1''. https://factfinder.census.gov/bkmk/table/1.0/en/DEC/10_SF1/GCTPH1.US05PR.
\15\ ``Population, Housing Units, Land Area, and Density for
U.S. Island Areas: 2010 (CPH-T-8)''. 10/28/2013. https://www.census.gov/data/tables/time-series/dec/cph-series/cph-t/cph-t-8.html.
---------------------------------------------------------------------------
Lastly, section 421(b)(1)(C) of the MMA provides for a category
comprised of rural counties or equivalent areas that are not included
in either the ``High utilization'' or the ``Low population density''
category. After determining which rural counties and equivalent areas
should be classified into the ``High utilization'' and ``Low population
density'' categories, we have determined that there are 1,162 remaining
rural counties and equivalent areas that do not meet the criteria for
inclusion in the ``High utilization'' or ``Low population density''
categories. We propose to classify these 1,162 rural counties and
[[Page 32375]]
equivalent areas into the ``All other'' category.
Section 421(b)(1) of the MMA specifies varying rural add-on payment
percentages and varying durations of rural add-on payments for home
health services furnished in a rural county or equivalent area
according to which category described in section 421(b)(1)(A),
421(b)(1)(B), or 421(b)(1)(C) of the MMA that the rural county or
equivalent area is classified into. The rural add-on payment
percentages and duration of rural add-on payments are shown in Table
26. The national standardized 60-day episode payment rate, the national
per-visit rates, and the NRS conversion factor will be increased by the
rural add-on payment percentages as noted in Table 26 when services are
provided in rural areas. The HH Pricer module, located within CMS'
claims processing system, will increase the base payment rates provided
in Tables 18 through 25 by the appropriate rural add-on percentage
prior to applying any case-mix and wage index adjustments.
Table 26--HH PPS Rural Add-On Percentages, CYs 2019-2022
----------------------------------------------------------------------------------------------------------------
Category CY 2019 (%) CY 2020 (%) CY 2021 (%) CY 2022 (%)
----------------------------------------------------------------------------------------------------------------
High utilization................................ 1.5 0.5 .............. ..............
Low population density.......................... 4.0 3.0 2.0 1.0
All other....................................... 3.0 2.0 1.0 ..............
----------------------------------------------------------------------------------------------------------------
Section 421(b)(2)(A) of the MMA provides that the Secretary shall
make a determination only for a single time as to which category under
sections 421(b)(1)(A), 421(b)(1)(B), or 421(b)(1)(C) of the MMA that a
rural county or equivalent area is classified into, and that the
determination applies for the entire duration of the period for which
rural add-on payments are in place under section 421(b) of the MMA. We
propose that our proposed classifications of rural counties and
equivalent areas in the ``High utilization'', ``Low population
density'', and ``All other'' categories would be applicable throughout
the period of rural add-on payments established under section 421(b) of
the MMA and there would be no changes in classifications. This would
mean that a rural county or equivalent area classified into the ``High
utilization'' category would remain in that category through CY 2022
even after rural add-on payments for that category ends after CY 2020.
Similarly, a rural county or equivalent area classified into the ``All
other'' category would remain in that category through CY 2022 even
after rural add-on payments for that category ends after CY 2021. A
rural county or equivalent area classified into the ``Low population
density'' category would remain in that category through CY 2022.
Section 421(b)(3) of the MMA provides that there shall be no
administrative or judicial review of the classification determinations
made for the rural add-on payments under section 421(b)(1) of the MMA.
Section 50208(a)(2) of the Bipartisan Budget Act of 2018 amended
section 1895(c) of the Act by adding a new requirement set out at
section 1895(c)(3) of the Act. This requirement states that no claim
for home health services may be paid unless ``in the case of home
health services furnished on or after January 1, 2019, the claim
contains the code for the county (or equivalent area) in which the home
health service was furnished.'' This information will be necessary in
order to calculate the rural add-on payments. We are proposing that
HHAs enter the FIPS state and county code, rather than the SSA state
and county code, on the claim. Many HHAs are more familiar with using
FIPS state and county codes since HHAs in a number of States are
already using FIPS state and county codes for State-mandated reporting
programs. Our analysis is based entirely on the SSA state and county
codes as these are the codes that are included in the Medicare
Beneficiary Summary File. We cross-walked the SSA state and county
codes used in our analysis to the FIPS state and county codes in order
to provide HHAs with the corresponding FIPS state and county codes that
should be reported on their claims.
The data used to categorize each county or equivalent area is
available in the Downloads section associated with the publication of
this proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Home-Health-Prospective-Payment-System-Regulations-and-Notices-Items/CMS-1689-P.html. In addition, an Excel
file containing the rural county or equivalent area names, their FIPS
state and county codes, and their designation into one of the three
rural add-on categories is available for download.
We are soliciting comments regarding our application of the
methodology specified by section 50208 of the Bipartisan Budget Act of
2018.
E. Proposed Payments for High-Cost Outliers Under the HH PPS
1. Background
Section 1895(b)(5) of the Act allows for the provision of an
addition or adjustment to the home health payment amount otherwise made
in the case of outliers because of unusual variations in the type or
amount of medically necessary care. Under the HH PPS, outlier payments
are made for episodes whose estimated costs exceed a threshold amount
for each Home Health Resource Group (HHRG). The episode's estimated
cost was established as the sum of the national wage-adjusted per-visit
payment amounts delivered during the episode. The outlier threshold for
each case-mix group or Partial Episode Payment (PEP) adjustment is
defined as the 60-day episode payment or PEP adjustment for that group
plus a fixed-dollar loss (FDL) amount. For the purposes of the HH PPS,
the FDL amount is calculated by multiplying the HH FDL ratio by a
case's wage-adjusted national, standardized 60-day episode payment
rate, which yields an FDL dollar amount for the case. The outlier
threshold amount is the sum of the wage and case-mix adjusted PPS
episode amount and wage-adjusted FDL amount. The outlier payment is
defined to be a proportion of the wage-adjusted estimated cost beyond
the wage-adjusted threshold. The proportion of additional costs over
the outlier threshold amount paid as outlier payments is referred to as
the loss-sharing ratio.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through
70399), section 3131(b)(1) of the Affordable Care Act amended section
1895(b)(3)(C) of the Act, and required the Secretary to reduce the HH
PPS payment rates such that aggregate HH PPS payments were
[[Page 32376]]
reduced by 5 percent. In addition, section 3131(b)(2) of the Affordable
Care Act amended section 1895(b)(5) of the Act by redesignating the
existing language as section 1895(b)(5)(A) of the Act, and revising the
language to state that the total amount of the additional payments or
payment adjustments for outlier episodes could not exceed 2.5 percent
of the estimated total HH PPS payments for that year. Section
3131(b)(2)(C) of the Affordable Care Act also added section
1895(b)(5)(B) of the Act which capped outlier payments as a percent of
total payments for each HHA at 10 percent.
As such, beginning in CY 2011, we reduce payment rates by 5 percent
and target up to 2.5 percent of total estimated HH PPS payments to be
paid as outliers. To do so, we first returned the 2.5 percent held for
the target CY 2010 outlier pool to the national, standardized 60-day
episode rates, the national per visit rates, the LUPA add-on payment
amount, and the NRS conversion factor for CY 2010. We then reduced the
rates by 5 percent as required by section 1895(b)(3)(C) of the Act, as
amended by section 3131(b)(1) of the Affordable Care Act. For CY 2011
and subsequent calendar years we target up to 2.5 percent of estimated
total payments to be paid as outlier payments, and apply a 10 percent
agency-level outlier cap.
In the CY 2017 HH PPS proposed and final rules (81 FR 43737 through
43742 and 81 FR 76702), we described our concerns regarding patterns
observed in home health outlier episodes. Specifically, we noted that
the methodology for calculating home health outlier payments may have
created a financial incentive for providers to increase the number of
visits during an episode of care in order to surpass the outlier
threshold; and simultaneously created a disincentive for providers to
treat medically complex beneficiaries who require fewer but longer
visits. Given these concerns, in the CY 2017 HH PPS final rule (81 FR
76702), we finalized changes to the methodology used to calculate
outlier payments, using a cost-per-unit approach rather than a cost-
per-visit approach. This change in methodology allows for more accurate
payment for outlier episodes, accounting for both the number of visits
during an episode of care and also the length of the visits provided.
Using this approach, we now convert the national per-visit rates into
per 15-minute unit rates. These per 15-minute unit rates are used to
calculate the estimated cost of an episode to determine whether the
claim will receive an outlier payment and the amount of payment for an
episode of care. In conjunction with our finalized policy to change to
a cost-per-unit approach to estimate episode costs and determine
whether an outlier episode should receive outlier payments, in the CY
2017 HH PPS final rule we also finalized the implementation of a cap on
the amount of time per day that would be counted toward the estimation
of an episode's costs for outlier calculation purposes (81 FR 76725).
Specifically, we limit the amount of time per day (summed across the
six disciplines of care) to 8 hours (32 units) per day when estimating
the cost of an episode for outlier calculation purposes.
We plan to publish the cost-per-unit amounts for CY 2019 in the
rate update change request, which is issued after the publication of
the CY 2019 HH PPS final rule. We note that in the CY 2017 HH PPS final
rule (81 FR 76724), we stated that we did not plan to re-estimate the
average minutes per visit by discipline every year. Additionally, we
noted that the per-unit rates used to estimate an episode's cost will
be updated by the home health update percentage each year, meaning we
would start with the national per-visit amounts for the same calendar
year when calculating the cost-per-unit used to determine the cost of
an episode of care (81 FR 76727). We note that we will continue to
monitor the visit length by discipline as more recent data become
available, and we may propose to update the rates as needed in the
future.
2. Proposed Fixed Dollar Loss (FDL) Ratio
For a given level of outlier payments, there is a trade-off between
the values selected for the FDL ratio and the loss-sharing ratio. A
high FDL ratio reduces the number of episodes that can receive outlier
payments, but makes it possible to select a higher loss-sharing ratio,
and therefore, increase outlier payments for qualifying outlier
episodes. Alternatively, a lower FDL ratio means that more episodes can
qualify for outlier payments, but outlier payments per episode must
then be lower.
The FDL ratio and the loss-sharing ratio must be selected so that
the estimated total outlier payments do not exceed the 2.5 percent
aggregate level (as required by section 1895(b)(5)(A) of the Act).
Historically, we have used a value of 0.80 for the loss-sharing ratio
which, we believe, preserves incentives for agencies to attempt to
provide care efficiently for outlier cases. With a loss-sharing ratio
of 0.80, Medicare pays 80 percent of the additional estimated costs
above the outlier threshold amount.
Simulations based on CY 2015 claims data (as of June 30, 2016)
completed for the CY 2017 HH PPS final rule showed that outlier
payments were estimated to represent approximately 2.84 percent of
total HH PPS payments in CY 2017, and as such, we raised the FDL ratio
from 0.45 to 0.55. We stated that raising the FDL ratio to 0.55, while
maintaining a loss-sharing ratio of 0.80, struck an effective balance
of compensating for high-cost episodes while still meeting the
statutory requirement to target up to, but no more than, 2.5 percent of
total payments as outlier payments (81 FR 76726). The national,
standardized 60-day episode payment amount is multiplied by the FDL
ratio. That amount is wage-adjusted to derive the wage-adjusted FDL
amount, which is added to the case-mix and wage-adjusted 60-day episode
payment amount to determine the outlier threshold amount that costs
have to exceed before Medicare would pay 80 percent of the additional
estimated costs.
For this proposed rule, simulating payments using preliminary CY
2017 claims data (as of March 2, 2018) and the CY 2018 HH PPS payment
rates (82 FR 51676), we estimate that outlier payments in CY 2018 would
comprise 2.30 percent of total payments. Based on simulations using CY
2017 claims data (as of March 2, 2018) and the proposed CY 2019 payment
rates presented in section III.C.4 of this proposed rule, we estimate
that outlier payments would constitute approximately 2.32 percent of
total HH PPS payments in CY 2019. Our simulations show that the FDL
ratio would need to be changed from 0.55 to 0.51 to pay up to, but no
more than, 2.5 percent of total payments as outlier payments in CY
2019.
Given the statutory requirement that total outlier payments not
exceed 2.5 percent of the total payments estimated to be made based
under the HH PPS, we are proposing to lower the FDL ratio for CY 2019
from 0.55 to 0.51 to better approximate the 2.5 percent statutory
maximum. However, we note that we are not proposing a change to the
loss-sharing ratio (0.80) for the HH PPS to remain consistent with
payment for high-cost outliers in other Medicare payment systems (for
example, IRF PPS, IPPS, etc.). We note that in the final rule, we will
update our estimate of outlier payments as a percent of total HH PPS
payments using the most current and complete year of HH PPS data (CY
2017 claims data as of June 30, 2018 or later) and therefore, we may
adjust the final FDL ratio accordingly. We invite public comments on
the
[[Page 32377]]
proposed change to the FDL ratio for CY 2019.
3. Home Health Outlier Payments: Clinical Example
In recent months, concerns regarding the provision of home health
care for Medicare patients with chronic, complex conditions have been
raised by stakeholders as well as the press.16 17 18 19 News
stories and anecdotal reports indicate that Medicare patients with
chronic conditions may be encountering difficulty in accessing home
health care if the goal of home health care is to maintain or prevent
further decline of the patient's condition rather than improvement of
the patient's condition. While patients must require skilled care to be
eligible to receive services under the Medicare home health benefit, as
outlined in regulation at 42 CFR 409.42(c), we note that coverage does
not turn on the presence or absence of an individual's potential for
improvement, but rather on the beneficiary's need for skilled care.
Skilled care is covered where such services are necessary to maintain
the patient's current condition or prevent or slow further
deterioration so long as the beneficiary requires skilled care for the
services to be safely and effectively provided. Additionally, there
appears to be confusion among the HHA provider community regarding
possible Medicare payment through the HH PPS, as it appears that some
perceive that payment is somewhat fixed and not able to account for
home health stays with higher costs.
---------------------------------------------------------------------------
\16\ https://www.npr.org/sections/health-shots/2018/01/17/578423012/home-care-agencies-often-wrongly-deny-medicare-help-to-the-chronically-ill.
\17\ http://www.alsa.org/als-care/resources/fyi/medicare-and-home-health-care.html.
\18\ https://patientworthy.com/2018/01/31/chronically-ill-are-being-denied-medicare-coverage-by-home-care-agencies/.
\19\ https://alsnewstoday.com/2018/05/09/als-medicare-cover-home-healthcare/.
---------------------------------------------------------------------------
The news stories referenced an individual with amyotrophic lateral
sclerosis (ALS), also known as Lou Gehrig's disease, and the
difficulties encountered in finding Medicare home health care. Below we
describe a clinical example of how care for a patient with ALS could
qualify for an additional outlier payment, which would serve to offset
unusually high costs associated with providing home health to a patient
with unusual variations in the amount of medically necessary care. This
example, using payment policies in place for CY 2018, is provided for
illustrative purposes only. We hope that in providing the example
below, which illustrates how HHAs could be paid by Medicare for
providing care to patients with higher resource use in their homes, and
by reiterating that the patient's condition does not need to improve
for home health services to be covered by Medicare, that there will be
a better understanding of Medicare coverage policies and how outlier
payments promote access to home health services for such patients under
the HH PPS.
a. Clinical Scenario
Amyotrophic Lateral Sclerosis (ALS) is a progressive neuromuscular
degenerative disease. The incidence rates of ALS have been increasing
over the last few decades, and the peak incidence rate occurs at age
75.\20\ The prevalence rate of ALS in the United States is 4.3 per
100,000 population.\21\ Half of all people affected with ALS live at
least 3 or more years after diagnosis. Twenty percent live 5 years or
more; up to 10 percent will live more than 10 years.\22\ Because of the
progressive nature of this disease, care needs change and generally
intensify as different body systems are affected. As such, patients
with ALS often require a multidisciplinary approach to meet their care
needs.
---------------------------------------------------------------------------
\20\ Worms PM, The epidemiology of motor neuron diseases: A
review of recent studies. J Neurol Sci. 2001;191(1-2):3.
\21\ Mehta P, Prevalence of Amyotrophic Lateral Sclerosis--
United States, 2012-2013. MMWR Surveill Summ. 2016;65(8):1. Epub
2016 Aug 5.
\22\ http://www.alsa.org.
---------------------------------------------------------------------------
The clinical care of a beneficiary with ALS typically includes the
ongoing assessment of and treatment for many impacts to the body
systems. As a part of a home health episode, a skilled nurse could
assess the patient for shortness of breath, mucus secretions,
sialorrhea, pressure sores, and pain. From these assessments, the nurse
could speak with the doctor about changes to the care plan. A nurse's
aide could provide assistance with bathing, dressing, toileting, and
transferring. Physical therapy services could also help the patient
with range of motion exercises, adaptive transfer techniques, and
assistive devices in order to maintain a level of function.
The following is a description of how the provision of services per
the home health plan of care could emerge for a beneficiary with ALS
who qualifies for the Medicare home health benefit. We note that this
example is provided for illustrative purposes only and does not
constitute a specific Medicare payment scenario.
b. Example One: Home Health Episodes 1 and 2
A beneficiary with ALS may be assessed by a physician in the
community and subsequently be deemed to require home health services
for skilled nursing, physical therapy, occupational therapy, and a home
health aide. The beneficiary could receive skilled nursing twice a week
for 45 minutes to assess dyspnea when transferring to a bedside
commode, stage two pressure ulcer at the sacrum, and pain status. In
addition, a home health aide could provide services for three hours in
the morning and three hours in the afternoon on Monday, Wednesday, and
Friday and two and a half hours in the morning and 2.5 hours in the
afternoon on Tuesday and Thursdays to assist with bathing, dressing,
and transferring. Physical therapy services twice a week for 45 minutes
could be provided for adaptive transfer techniques, and occupational
therapy services could be supplied twice a week for 45 minutes for
assessment and teaching of assistive devices for activities of daily
living to prevent or slow deterioration of the patient's condition.
Given the patient's clinical presentation, for the purpose of this
specific example, we will assign the patient payment group 40331
(C3F3S1 with 20+ therapy visits).
For the purposes of this example, we assume that services are
rendered per week for a total of 8 weeks per home health episode. For
both the first and second home health episodes of care, the calculation
to determine outlier payment utilizing payment amounts and case mix
weights for CY 2018, as described in the CY 2018 HH PPS final rule (82
FR 51676), would be as follows, per 60-day episode:
Table 27--Clinical Scenario Calculation Table: Episodes 1 and 2
----------------------------------------------------------------------------------------------------------------
HH outlier--CY 2018 illustrative values Value Operation Adjuster Equals Output
----------------------------------------------------------------------------------------------------------------
National, Standardized 60-day Episode Payment Rate $3,039.64 ........... .......... ........... ..........
[[Page 32378]]
Case-Mix Weight for Payment Group 4.0331 (for 2.1359 ........... .......... ........... ..........
C3F3S1 for 20+ therapy ).........................
Case-Mix Adjusted Episode Payment Amount.......... 3,039.64 * 2.1359 = 6,492.37
Labor Portion of the Case-Mix Adjusted Episode 6,492.37 * 0.78535 - 5,098.78
Payment Amount...................................
Non-Labor Portion of the Case-Mix Adjusted Episode 6,492.37 * 0.21465 = 1,393.59
Payment Amount...................................
Wage Index Value (Beneficiary resides in 31084, 1.2781 ........... .......... ........... ..........
Los Angeles-Long Beach-Glendale, CA).............
Wage-Adjusted Labor Portion of the Case-Mix 5,098.78 * 1.2781 = 6,516.75
Adjusted Episode Payment Amount..................
NRS Payment Amount (Severity Level 2)............. 51.66 ........... .......... = 51.66
-------------------------------------------------------------
Total Case-Mix and Wage-Adjusted Episode .......... ........... .......... = 7,962.00
Payment Amount (Wage-Adjusted Labor Portion
plus Non-Labor Portion of the Case-Mix
Adjusted Episode Payment Amount plus the NRS
Amount)......................................
Total Wage-Adjusted Fixed Dollar Loss Amount:
Fixed Dollar Loss Amount (National, 3,039.64 * 0.55 = 1,671.80
Standardized 60-day Episode Payment Rate *
FDL Ratio)...................................
Labor Portion of the Fixed Dollar Loss Amount. 1,671.80 * 0.78535 = 1,312.95
Non-Labor Amount of the Fixed Dollar Loss 1,671.80 * 0.21465 = 358.85
Amount.......................................
Wage-Adjusted Fixed Dollar Loss Amount........ 1,312.95 * 1.2781 = 1,678.08
-------------------------------------------------------------
Total Wage-Adjusted Fixed Dollar Loss 1,678.08 + 358.85 = 2,036.93
Amount (Wage-Adjusted Labor Portion plus
Non-Labor Portion of the Case-Mix
Adjusted Fixed Dollar Loss Amount).......
Total Wage-Adjusted Imputed Cost Amount:
National Per-Unit Payment Amount--Skilled 48.01 ........... .......... ........... ..........
Nursing......................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed Skilled Nursing Visit Costs (National 48.01 * 48 = 2,304.48
Per-Unit Payment Amount * Number of Units)...
National Per-Unit Payment Amount--Home Health 15.46 ........... .......... ........... ..........
Aide.........................................
Number of 15-minute units (28 hours per week = 896 ........... .......... ........... ..........
112 units per week for 8 weeks)..............
Imputed Home Health Aide Costs (National Per- 15.46 * 896 = 13,852.16
Unit Payment Amount * Number of Units).......
National Per-Unit Payment Amount--Occupational 50.26 ........... .......... ........... ..........
Therapy (OT).................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed OT Visit Costs (National Per-Unit 50.26 * 48 = 2,412.48
Payment Amount * Number of Units)............
National Per-Unit Payment Amount--Physical 50.46 ........... .......... ........... ..........
Therapy (PT).................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed PT Visit Costs (National Per-Unit 50.46 * 48 = 2,422.08
Payment Amount * Number of Units)............
-------------------------------------------------------------
Total Imputed Cost Amount for all .......... ........... .......... = 20,991.20
Disciplines..............................
Labor Portion of the Imputed Costs for All 20,991.20 * 0.78535 = 16,485.44
Disciplines..................................
Non-Labor Portion of Imputed Cost Amount for 20,991.20 * 0.21465 = 4,505.76
All Disciplines..............................
CBSA Wage Index (Beneficiary resides in 31084, 1.2781 ........... .......... ........... ..........
Los Angeles-Long Beach-Glendale, CA).........
Wage-Adjusted Labor Portion of the Imputed 16,485.44 * 1.2781 = 21,070.04
Cost Amount for All Disciplines..............
-------------------------------------------------------------
Total Wage-Adjusted Imputed Cost Amount 21,070.04 + 4,505.76 = 25,575.80
(Wage-Adjusted Labor Portion of the
Imputed Cost Amount plus Non-Labor
Portion of the Imputed Cost Amount)......
Total Payment Per 60-Day Episode:
Outlier Threshold Amount (Total Wage-Adjusted 2,036.93 + 7,962.00 = 9,998.93
Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount)........
Total Wage-Adjusted Imputed Cost Amount-- 25,575.80 - 9,998.93 = 15,576.87
Outlier Threshold Amount (Total Wage-Adjusted
Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount)........
Outlier Payment = Imputed Costs Greater Than 15,576.87 * 0.80 = 12,461.50
the Outlier Threshold * Loss-Sharing Ratio
(0.80).......................................
-------------------------------------------------------------
Total Payment Per 60-Day Episode = Total 7,962.00 + 12,461.50 = 20,423.49
Case-Mix and Wage-Adjusted Episode
Payment Amount + Outlier Payment.........
----------------------------------------------------------------------------------------------------------------
[[Page 32379]]
For Episodes 1 and 2 of this clinical scenario, the preceding
calculation illustrates how HHAs are paid by Medicare for providing
care to patients with higher resource use in their homes.
c. Example Two: Home Health Episodes 3 and 4
ALS is a progressive disease such that the patient would most
likely need care beyond a second 60-day HH episode. A beneficiary's
condition could become more complex, such that the patient could
require a gastrostomy tube, which could be placed during a hospital
stay. The patient could be discharged to home for enteral nutrition to
maintain weight and continuing care for his/her stage two pressure
ulcer. Given the complexity of the beneficiary's condition in this
example, the episode could remain at the highest level of care C3F3S1
and would now fit into equation 4.
For the purposes of this example, we assume that services are
rendered per week for a total of 8 weeks per home health episode. For
both the third and fourth home health episodes of care, the calculation
to determine outlier payment utilizing payment amounts and case mix
weights for CY 2018 as described in as described in the CY 2018 HH PPS
final rule (82 FR 51676) would be as follows, per 60-day episode:
Table 28--Clinical Scenario Calculation: Episodes 3 and 4
----------------------------------------------------------------------------------------------------------------
HH outlier--CY 2018 illustrative values Value Operation Adjuster Equals Output
----------------------------------------------------------------------------------------------------------------
National, Standardized 60-day Episode Payment Rate $3,039.64 ........... .......... ........... ..........
Case-Mix Weight for Payment Group 4.0331 (for 2.1359 ........... .......... ........... ..........
C3F3S1 for 20+ therapy)..........................
Case-Mix Adjusted Episode Payment Amount.......... 3,039.64 * 2.1359 = $6,492.37
Labor Portion of the Case-Mix Adjusted Episode 6,492.37 * 0.78535 = 5,098.78
Payment Amount...................................
Non-Labor Portion of the Case-Mix Adjusted Episode 6,492.37 * 0.21465 = 1,393.59
Payment Amount...................................
Wage Index Value (Beneficiary resides in 31084, 1.2781 ........... .......... ........... ..........
Los Angeles-Long Beach-Glendale, CA).............
Wage-Adjusted Labor Portion of the Case-Mix 5,098.78 * 1.2781 = 6,516.75
Adjusted Episode Payment Amount..................
NRS Payment Amount (Severity Level 2)............. 324.53 ........... .......... = 324.53
-------------------------------------------------------------
Total Case-Mix and Wage-Adjusted Episode .......... ........... .......... = 8,234.87
Payment Amount (Wage-Adjusted Labor Portion
plus Non-Labor Portion of the Case-Mix
Adjusted Episode Payment Amount plus the NRS
Amount)......................................
Total Wage-Adjusted Fixed Dollar Loss Amount:
Fixed Dollar Loss Amount (National, 3,039.64 * 0.55 = 1,671.80
Standardized 60-day Episode Payment Rate *
FDL Ratio)...................................
Labor Portion of the Fixed Dollar Loss Amount. 1,671.80 * 0.78535 = 1,312.95
Non-Labor Amount of the Fixed Dollar Loss 1,671.80 * 0.21465 = 358.85
Amount.......................................
Wage-Adjusted Fixed Dollar Loss Amount........ 1,312.95 * 1.2781 = 1,678.08
-------------------------------------------------------------
Total Wage-Adjusted Fixed Dollar Loss 1,678.08 + 358.85 = 2,036.93
Amount (Wage-Adjusted Labor Portion plus
Non-Labor Portion of the Case-Mix
Adjusted Fixed Dollar Loss Amount).......
Total Wage-Adjusted Imputed Cost Amount:
National Per-Unit Payment Amount--Skilled 48.01 ........... .......... ........... ..........
Nursing......................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed Skilled Nursing Visit Costs (National 48.01 * 48 = 2,304.48
Per-Unit Payment Amount * Number of Units)...
National Per-Unit Payment Amount--Home Health 15.46 ........... .......... ........... ..........
Aide.........................................
Number of 15-minute units (28 hours per week = 896 ........... .......... ........... ..........
112 units per week for 8 weeks)..............
Imputed Home Health Aide Costs (National Per- 15.46 * 896 = 13,852.16
Unit Payment Amount * Number of Units).......
National Per-Unit Payment Amount--Occupational 50.26 ........... .......... ........... ..........
Therapy (OT).................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed OT Visit Costs (National Per-Unit 50.26 * 48 = 2,412.48
Payment Amount * Number of Units)............
National Per-Unit Payment Amount--Physical 50.46 ........... .......... ........... ..........
Therapy (PT).................................
Number of 15-minute units (45 minutes = 3 48 ........... .......... ........... ..........
units twice per week for 8 weeks)............
Imputed PT Visit Costs (National Per-Unit 50.46 * 48 = 2,422.08
Payment Amount * Number of Units)............
-------------------------------------------------------------
Total Imputed Cost Amount for all .......... ........... .......... = 20,991.20
Disciplines..............................
Labor Portion of the Imputed Costs for All 20,991.20 * 0.78535 = 16,485.44
Disciplines..................................
Non-Labor Portion of Imputed Cost Amount for 20,991.20 * 0.21465 = 4,505.76
All Disciplines..............................
CBSA Wage Index (Beneficiary resides in 31084, 1.2781 ........... .......... ........... ..........
Los Angeles-Long Beach-Glendale, CA).........
Wage-Adjusted Labor Portion of the Imputed 16,485.44 * 1.2781 = 21,070.04
Cost Amount for All Disciplines..............
-------------------------------------------------------------
Total Wage-Adjusted Imputed Cost Amount 21,070.04 + 4,505.76 = 25,575.80
(Wage-Adjusted Labor Portion of the
Imputed Cost Amount plus Non-Labor
Portion of the Imputed Cost Amount)......
Total Payment Per 60-Day Episode:
[[Page 32380]]
Outlier Threshold Amount (Total Wage-Adjusted 2,036.93 + 8,234.87 = 10,271.80
Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount)........
Total Wage-Adjusted Imputed Cost Amount- 25,575.80 - 10,271.80 = 15,304.00
Outlier Threshold Amount (Total Wage-Adjusted
Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount)........
Outlier Payment = Imputed Costs Greater Than 15,304.00 * 0.80 = 12,243.20
the Outlier Threshold * Loss-Sharing Ratio
(0.80).......................................
-------------------------------------------------------------
Total Payment Per 60-Day Episode = Total 12,243.20 + 8,234.87 = 20,478.07
Case-Mix and Wage-Adjusted Episode
Payment Amount + Outlier Payment.........
----------------------------------------------------------------------------------------------------------------
For Episodes 3 and 4 of this clinical scenario, the above
calculation demonstrates how outlier payments could be made for
patients with chronic, complex conditions under the HH PPS. We
reiterate that outlier payments could provide payment to HHAs for those
patients with higher resource use and that the patient's condition does
not need to improve for home health services to be covered by Medicare.
We appreciate the feedback we have received from the public on the
outlier policy under the HH PPS and look forward to ongoing
collaboration with stakeholders on any further refinements that may be
warranted. We note that this example is presented for illustrative
purposes only, and is not intended to suggest that all diagnoses of ALS
should receive the grouping assignment or number of episodes described
here. The CMS Grouper assigns these groups based on information in the
OASIS.
F. Implementation of the Patient-Driven Groupings Model (PDGM) for CY
2020
1. Background and Legislation, Overview, Data, and File Construction
a. Background and Legislation
In the CY 2018 HH PPS proposed rule, we proposed an alternative
case mix-adjustment methodology (known as the Home Health Groupings
Model or HHGM), to be implemented for home health periods of care
beginning on or after January 1, 2019. Ultimately this proposed
alternative case-mix adjustment methodology, including a proposed
change in the unit of payment from 60 days to 30 days, was not
finalized in the CY 2018 HH PPS final rule in order to allow us
additional time to consider public comments for potential refinements
to the methodology (82 FR 51676).
On February 9, 2018, the Bipartisan Budget Act of 2018 (BBA of
2018) (Pub. L. 115-123) was signed into law. Section 51001(a)(1) of the
BBA of 2018 amended section 1895(b)(2) of the Act by adding a new
subparagraph (B) to require the Secretary to apply a 30-day unit of
service for purposes of implementing the HH PPS, effective January 1,
2020. Section 51001(a)(2)(A) of the BBA of 2018 added a new subclause
(iv) under section 1895(b)(3)(A) of the Act, requiring the Secretary to
calculate a standard prospective payment amount (or amounts) for 30-day
units of service that end during the 12-month period beginning January
1, 2020 in a budget neutral manner such that estimated aggregate
expenditures under the HH PPS during CY 2020 are equal to the estimated
aggregate expenditures that otherwise would have been made under the HH
PPS during CY 2020 in the absence of the change to a 30-day unit of
service. Section 1895(b)(3)(A)(iv) of the Act requires that the
calculation of the standard prospective payment amount (or amounts) for
CY 2020 be made before, and not affect the application of, the
provisions of section 1895(b)(3)(B) of the Act. Section
1895(b)(3)(A)(iv) of the Act additionally requires that in calculating
the standard prospective payment amount (or amounts), the Secretary
must make assumptions about behavioral changes that could occur as a
result of the implementation of the 30-day unit of service under
section 1895(b)(2)(B) of the Act and case-mix adjustment factors
established under section 1895(b)(4)(B) of the Act. Section
1895(b)(3)(A)(iv) of the Act further requires the Secretary to provide
a description of the behavioral assumptions made in notice and comment
rulemaking.
Section 51001(a)(2)(B) of the BBA of 2018 also added a new
subparagraph (D) to section 1895(b)(3) of the Act. Section
1895(b)(3)(D)(i) of the Act requires the Secretary to annually
determine the impact of differences between assumed behavior changes as
described in section 1895(b)(3)(A)(iv) of the Act, and actual behavior
changes on estimated aggregate expenditures under the HH PPS with
respect to years beginning with 2020 and ending with 2026. Section
1895(b)(3)(D)(ii) of the Act requires the Secretary, at a time and in a
manner determined appropriate, through notice and comment rulemaking,
provide for one or more permanent increases or decreases to the
standard prospective payment amount (or amounts) for applicable years,
on a prospective basis, to offset for such increases or decreases in
estimated aggregate expenditures, as determined under section
1895(b)(3)(D)(i) of the Act. Additionally, 1895(b)(3)(D)(iii) of the
Act requires the Secretary, at a time and in a manner determined
appropriate, through notice and comment rulemaking, to provide for one
or more temporary increases or decreases to the payment amount for a
unit of home health services for applicable years, on a prospective
basis, to offset for such increases or decreases in estimated aggregate
expenditures, as determined under section 1895(b)(3)(D)(i) of the Act.
Such a temporary increase or decrease shall apply only with respect to
the year for which such temporary increase or decrease is made, and the
Secretary shall not take into account such a temporary increase or
decrease in computing the payment amount for a unit of home health
services for a subsequent year.
Section 51001(a)(3) of the BBA of 2018 amends section 1895(b)(4)(B)
of the Act by adding a new clause (ii) to require the Secretary to
eliminate the use of therapy thresholds in the case-mix system for 2020
and subsequent years. Lastly, section 51001(b)(4) of the BBA of 2018
requires the Secretary to pursue notice and comment rulemaking no later
than December 31, 2019 on a revised case-mix system for payment of home
health services under the HH PPS
b. Overview
To meet the requirement under section 51001(b)(4) of the BBA of
2018 to engage in notice and comment rulemaking on a HH PPS case-mix
system and to better align payment with
[[Page 32381]]
patient care needs and better ensure that clinically complex and ill
beneficiaries have adequate access to home health care, we are
proposing case-mix methodology refinements through the implementation
of the Patient-Driven Groupings Model (PDGM). The proposed PDGM shares
many of the features included in the alternative case mix-adjustment
methodology proposed in the CY 2018 HH PPS proposed rule. We propose to
implement the PDGM for home health periods of care beginning on or
after January 1, 2020. The implementation of the PDGM will require
provider education and training, updating and revising relevant
manuals, and changing claims processing systems. Implementation
starting in CY 2020 would provide opportunity for CMS, its contractors,
and the agencies themselves to prepare. This patient-centered model
groups periods of care in a manner consistent with how clinicians
differentiate between patients and the primary reason for needing home
health care. As required by section 1895(b)(2)(B) of the Act, we
propose to use 30-day periods rather than the 60-day episode used in
the current payment system. In addition, section 1895(b)(4)(B)(ii) of
the Act eliminates the use of therapy thresholds in the case-mix
adjustment for determining payment. The proposed PDGM does not use the
number of therapy visits in determining payment. The change from the
current case-mix adjustment methodology for the HH PPS, which relies
heavily on therapy thresholds as a major determinant for payment and
thus provides a higher payment for a higher volume of therapy provided,
to the PDGM would remove the financial incentive to overprovide therapy
in order to receive a higher payment. The PDGM would base case-mix
adjustment for home health payment solely on patient characteristics, a
more patient-focused approach to payment. Finally, the PDGM relies more
heavily on clinical characteristics and other patient information (for
example, diagnosis, functional level, comorbid conditions, admission
source) to place patients into clinically meaningful payment
categories. In total, there are 216 different payment groups in the
PDGM.
Costs during an episode/period of care are estimated based on the
concept of resource use, which measures the costs associated with
visits performed during a home health episode/period. For the current
HH PPS case-mix weights, we use Wage Weighted Minutes of Care (WWMC),
which uses data from the Bureau of Labor Statistics (BLS) reflecting
the Home Health Care Service Industry. For the PDGM, we propose
shifting to a Cost-Per-Minute plus Non-Routine Supplies (CPM + NRS)
approach, which uses information from the Medicare Cost Report. The CPM
+ NRS approach incorporates a wider variety of costs (such as
transportation) compared to the BLS estimates and the costs are
available for individual HHA providers while the BLS costs are
aggregated for the Home Health Care Service industry.
Similar to the current payment system, 30-day periods under the
PDGM would be classified as ``early'' or ``late'' depending on when
they occur within a sequence of 30-day periods. Under the current HH
PPS, the first two 60-day episodes of a sequence of adjacent 60-day
episodes are considered early, while the third 60-day episode of that
sequence and any subsequent episodes are considered late. Under the
PDGM, the first 30-day period is classified as early. All subsequent
30-day periods in the sequence (second or later) are classified as
late. We propose to adopt this timing classification for 30-day periods
with the implementation of the PDGM for CY 2020. Similar to the current
payment system, we propose that a 30-day period could not be considered
early unless there was a gap of more than 60 days between the end of
one period and the start of another. The comprehensive assessment would
still be completed within 5 days of the start of care date and
completed no less frequently than during the last 5 days of every 60
days beginning with the start of care date, as currently required by
Sec. 484.55, Condition of participation: Comprehensive assessment of
patients. In addition, the plan of care would still be reviewed and
revised by the HHA and the physician responsible for the home health
plan of care no less frequently than once every 60 days, beginning with
the start of care date, as currently required by Sec. 484.60(c),
Condition of participation: Care planning, coordination of services,
and quality of care.
Under the PDGM, we propose that each period would be classified
into one of two admission source categories --community or
institutional-- depending on what healthcare setting was utilized in
the 14 days prior to home health. The 30-day period would be
categorized as institutional if an acute or post-acute care stay
occurred in the 14 days prior to the start of the 30-day period of
care. The 30-day period would be categorized as community if there was
no acute or post-acute care stay in the 14 days prior to the start of
the 30-day period of care.
The PDGM would group 30-day periods into categories based on a
variety of patient characteristics. We propose grouping periods into
one of six clinical groups based on the principal diagnosis. The
principal diagnosis reported would provide information to describe the
primary reason for which patients are receiving home health services
under the Medicare home health benefit. The proposed six clinical
groups, are as follows:
Musculoskeletal Rehabilitation.
Neuro/Stroke Rehabilitation.
Wounds--Post-Op Wound Aftercare and Skin/Non-Surgical
Wound Care.
Complex Nursing Interventions.
Behavioral Health Care (including Substance Use
Disorders).
Medication Management, Teaching and Assessment (MMTA).
Under the PDGM, we propose that each 30-day period would be placed
into one of three functional levels. The level would indicate if, on
average, given its responses on certain functional OASIS items, a 30-
day period is predicted to have higher costs or lower costs. We are
proposing to assign roughly 33 percent of periods within each clinical
group to each functional level. The criteria for assignment to each of
the three functional levels may differ across each clinical group. The
proposed functional level assignment under the PDGM is very similar to
the functional level assignment in the current payment system. Finally,
the PDGM includes a comorbidity adjustment category based on the
presence of secondary diagnoses. We propose that, depending on a
patient's secondary diagnoses, a 30-day period may receive ``no''
comorbidity adjustment, a ``low'' comorbidity adjustment, or a ``high''
comorbidity adjustment. For low-utilization payment adjustments (LUPAs)
under the PDGM, we propose that the LUPA threshold would vary for a 30-
day period under the PDGM depending on the PDGM payment group to which
it is assigned. For each payment group, we propose to use the 10th
percentile value of visits to create a payment group specific LUPA
threshold with a minimum threshold of at least 2 for each group.
Figure BBB1 represents how each 30-day period of care would be
placed into one of the 216 home health resource groups (HHRGs) under
the proposed PDGM for CY 2020.
BILLING CODE 4210-01-P
[[Page 32382]]
TP12JY18.003
BILLING CODE 4210-01-C
c. Data and File Construction
To create the PDGM proposed model and related analyses, a data file
based on home health episodes of care as reported in Medicare home
health claims was utilized. The claims data provide episode-level data
(for example, episode From and Through Dates, total number of visits,
HHRG, diagnoses), as well as visit-level data (visit date, visit length
in 15-minute units, discipline of the staff, etc.). The claims also
provide data on whether NRS was provided during the episode and total
charges for NRS.
The core file for most of the analyses for this proposed rule
includes 100 percent of home health episode claims with Through Dates
in Calendar Year (CY) 2017, processed by March 2, 2018, accessed via
the Chronic Conditions Data Warehouse (CCW). Original or adjustment
claims processed after March 2, 2018, would not be reflected in the
core file. The claims-based file was supplemented with additional
variables that were obtained from the CCW, such as information
regarding other Part A and Part B utilization.
The data were cleaned by processing any remaining adjustments and
by
[[Page 32383]]
excluding duplicates and claims that were Requests for Anticipated
Payment (RAP). In addition, visit-level variables needed for the
analysis were extracted from the revenue center trailers (that is, the
line items that describe the visits) and downloaded as a separate
visit-level file, with selected episode-level variables merged onto the
records for visits during those episodes. To account for potential data
entry errors, the visit-level variables for visit length were top-
censored at 8 hours.\23\
---------------------------------------------------------------------------
\23\ Less than 0.1 percent of all visits were recorded as having
greater than 8 hours of service.
---------------------------------------------------------------------------
A set of data cleaning exclusions were applied to the episode-level
file, which resulted in the exclusion of the following:
Episodes that were RAPs.
Episodes with no covered visits.
Episodes with any missing units or visit data.
Episodes with zero payments.
Episodes with no charges.
Non-LUPA episodes missing an HHRG.
The analysis file also includes data on patient characteristics
obtained from the OASIS assessments conducted by home health agency
(HHA) staff at the start of each episode. The assessment data are
electronically submitted by HHAs to a central CMS repository. In
constructing the core data file, 100 percent of the OASIS assessments
submitted October 2016 through December 2017 from the CMS repository
were uploaded by CMS to the CCW. A CCW-derived linking key (Bene ID)
was used to match the OASIS data with CY 2017 episodes of care.
Episodes that could not be linked with an OASIS assessment were
excluded from the analysis file, as they included insufficient patient-
level data to create the PDGM.
To construct measures of resource use, a variety of data sources
were used (see section III.F.2 of this proposed rule for the proposed
methodology used to calculate the cost of care under the PDGM). First,
BLS data on average wages and fringe benefits were used to produce
wage-weighted minutes of care (WWMC), the approach used in the current
system to calculate the cost of care. The wage data are for North
American Industry Classification System (NAICS) 621600--Home Health
Care Services (see Table 29).
Table 29--BLS Standard Occupation Classification (SOC) Codes for Home
Health Providers
------------------------------------------------------------------------
Standard Occupation Code (SOC) No. Occupation title
------------------------------------------------------------------------
29-1141............................... Registered Nurses.
29-2061............................... Licensed Practical and Licensed
Vocational Nurses.
29-1123............................... Physical Therapists.
31-2021............................... Physical Therapist Assistants.
31-2022............................... Physical Therapist Aides.
29-1122............................... Occupational Therapists.
31-2011............................... Occupational Therapist
Assistants.
31-2012............................... Occupational Therapist Aides.
29-1127............................... Speech-Language Pathologists.
21-1022............................... Medical and Public Health Social
Workers.
21-1023............................... Mental Health and Substance
Abuse Social Workers.
31-1011............................... Home Health Aides.
------------------------------------------------------------------------
The WWMC approach determines resource use for each episode by
multiplying utilization (in terms of the number of minutes of direct
patient care provided by each discipline) by the corresponding
opportunity cost of that care (represented by wage and fringe benefit
rates from the BLS).\24\ Table 30 shows the occupational titles and
corresponding mean hourly wage rates from the BLS. The employer cost
per hour worked shown in the fifth column is calculated by adding
together the mean hourly wage rates and the fringe benefit rates from
the BLS. For home health disciplines that include multiple occupations
(such as skilled nursing), the opportunity cost is generated by
weighting the employer cost by the proportions of the labor mix.\25\
Otherwise, the opportunity cost is the same as the employer cost per
hour.
---------------------------------------------------------------------------
\24\ Opportunity costs represent the foregone resources from
providing each minute of care versus using the resources for another
purpose (the next best alternative). Generally, opportunity costs
represent more than the monetary costs, but in these analyses, they
are proxied using hourly wage rates.
\25\ Labor mix represents the percentage of employees with a
particular occupational title (as obtained from claims) within a
home health discipline. Physical therapist aides and occupational
therapist aides were not included in the labor mix.
Table 30--Occupational Employment and Wages Provided by the Federal Bureau of Labor Statistics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimate of Estimated
National Mean hourly benefits as employer Labor Opportunity
Occupation title employment wage a % of cost per mix Home health discipline cost
counts wages hour worked
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registered Nurses.......................... 179,280 $33.34 43.85 $47.96 0.66 Skilled Nursing............... $42.42
Licensed Practical and Licensed Vocational 85,410 22.03 43.85 31.69 0.34
Nurses.
Physical Therapists........................ 24,810 47.23 40.92 66.55 0.66 Physical Therapy.............. 58.55
Physical Therapist Assistants.............. 7,330 31.43 35.79 42.68 0.34
Occupational Therapists.................... 10,760 45.27 40.92 63.79 0.79 Occupational Therapy.......... 59.97
Occupational Therapist Assistants.......... 2,270 33.83 35.79 45.94 0.21
Speech-Language Pathologists............... 5,360 47.08 40.92 66.34 ....... Speech Therapy................ 66.34
Medical and Public Health Social Workers... 18,930 28.76 40.92 40.53 0.97 Medical Social Service........ 40.42
Mental Health and Substance Abuse Social 500 25.85 40.92 36.43 0.03
Workers.
Home Health Aides.......................... 408,920 11.25 35.79 15.28 ....... Home Health Aide.............. 15.28
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: May 2016 National Industry-Specific Occupational Employment and Wage Estimates--NAICS 621600--Home Health Care Services.
[[Page 32384]]
Home Health Agency Medicare Cost Report (MCR) data for FY 2016 were
also used to construct a measure of resource use after trimming out
HHAs whose costs were outliers (see section III.F.2 of this proposed
rule). These data are used to provide a representation of the average
costs of visits provided by HHAs in the six Medicare home health
disciplines: Skilled nursing; physical therapy; occupational therapy;
speech-language pathology; medical social services; and home health
aide services. Cost report data are publicly available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Cost-Reports/. More details regarding how HHA MCR data were
used in constructing the CPM+NRS measure of resource use can be found
in section III.F.2 of this proposed rule.
A comment submitted in response to the CY 2018 HH PPS proposed rule
questioned the trimming process for the Medicare cost report data used
to calculate the cost-per-minute plus non-routine supplies (CPM+NRS)
methodology used to estimate resource use (outlined in section III.F.2
of this rule). The commenter stated that for rebasing, CMS audited 100
cost reports and the findings of such audits found that costs were
overstated by 8 percent and that finding was attributed to the entire
population of HHA Medicare cost reports. The commenter questioned if
CMS applied the 8 percent ``adjustment factor'' in last year's proposed
rule, requested CMS provide the number of cost reports used for the
proposed rule, asked if only cost reports of freestanding HHAs were
used, and requested that CMS describe what percentage of cost reports
did not list any costs for NRS, yet listed NRS charges.
For the calculations in the CY 2018 HH PPS proposed rule, CMS
applied the trimming methodology described in detail in the ``Analyses
in Support of Rebasing & Updating Medicare Home Health Payment Rates''
Report available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Analyses-in-Support-of-Rebasing-and-Updating-the-Medicare-Home-Health-Payment-Rates-Technical-Report.pdf. This is also the trimming methodology outlined in the CY
2014 HH PPS proposed rule (78 FR 40284). Of note, for each discipline
and for NRS, we also followed the methodology laid out in the
``Rebasing Report'' by trimming out values that fell in the top or
bottom 1 percent of the distribution across all HHAs. This included the
cost-per-visit values for each discipline and NRS cost-to-charge ratios
that fell in the top or bottom 1 percent of the distribution across all
HHAs. For this proposed rule, we applied the same trimming methodology.
We included both freestanding and facility-based HHA Medicare cost
report data in our rebasing calculations as outlined in the CY 2014 HH
PPS proposed and final rules and in our analysis of FY 2015 HHA
Medicare cost report data for the CY 2018 HH PPS proposed rule. We
similarly included both freestanding and facility-based HHA Medicare
cost report data in our analysis of FY 2016 cost report data for this
proposed rule. We note that although we found an 8 percent
overstatement of costs from the Medicare cost reports audits performed
to support the rebasing adjustments, we did not apply an 8 percent
adjustment to HHA costs in the CY 2014 HH PPS proposed or final rules.
We also did not apply an 8 percent adjustment to the costs in the CY
2018 HH PPS proposed rule or in this proposed rule. The 8 percent
overstatement was determined using a small sample size of HHA Medicare
cost reports and the CY 2014 HH PPS proposed rule included this
information as illustrative only. The information was not used in any
cost calculations past or present.
Before trimming, there were 10,394 cost reports for FY 2016. In
this proposed rule, we used 7,458 cost reports. Of the 7,458 cost
reports, 5,447 (73.4 percent) had both NRS charges and costs, 1,672
(22.4 percent) had neither NRS charges or costs, and 339 (4.5 percent)
had NRS charges but no NRS costs. There were no cost reports with NRS
costs, but no NRS charges.
The initial 2017 analytic file included 6,771,059 episodes. Of
these, 959,410 (14.2 percent) were excluded because they could not be
linked to OASIS assessments or because of the claims data cleaning
process reasons listed above. This yielded a final analytic file that
included 5,811,649 episodes. Those episodes are 60-day episodes under
the current payment system, but for the PDGM those 60-day episodes were
converted into two 30-day periods. This yielded a final PDGM analytic
file that included 10,160,226, 30-day periods. Certain 30-day periods
were excluded for the following reasons:
Inability to merge to certain OASIS items to create the
episode's functional level that is used for risk adjustment. For all
the periods in the analytic file, there was a look-back through CY 2016
for a period with a Start of Care or Resumption of Care assessment that
preceded the period being analyzed and was in the same sequence of
periods. If such an assessment was found, it was used to impute
responses for OASIS items that were not included in the follow-up
assessment. Periods that were linked to a follow-up assessment which
did not link to a Start of Care or Resumption of Care assessment using
the process described above were dropped (after exclusions, n =
9,471,529).
No nursing visits or therapy visits (after exclusions, n =
9,287,622).
LUPAs were excluded from the analysis. Periods that are
identified as LUPAs in the current payment system were excluded in the
creation of the functional score. Following the creation of the score
(and the corresponding levels), case-mix group specific LUPA thresholds
were created and episodes/periods were excluded that were below the new
LUPA threshold when computing the case-mix weights.\26\ Therefore, the
final analytic sample included 8,624,776 30-day periods that were used
for the analyses in the PDGM.
---------------------------------------------------------------------------
\26\ The case-mix group specific LUPA thresholds were determined
using episodes that were considered LUPAs under the current payment
system.
---------------------------------------------------------------------------
In response to the CY 2018 HH PPS proposed rule, we received many
comments stating there was limited involvement with the industry in the
development of the alternative case-mix adjustment methodology.
Commenters also stated that they were unable to obtain the necessary
data in order to replicate and model the effects on their business. We
note that, through notice and comment rulemaking and other processes,
stakeholders always have the opportunity to reach out to CMS and
provide suggestions for improvement in the payment methodology under
the HH PPS. In the CY 2014 HH PPS final rule, we noted that we were
continuing to work on improvements to our case-mix adjustment
methodology and welcomed suggestions for improving the case-mix
adjustment methodology as we continued in our case-mix research (78 FR
72287). The analyses and the ultimate development of an alternative
case-mix adjustment methodology was shared with stakeholders via
technical expert panels, clinical workgroups, and special open door
forums. We also provided high-level summaries on our case-mix
methodology refinement work in the HH PPS proposed rules for CYs 2016
and 2017 (80 FR 39839, and 81 FR 76702). A detailed technical report
was posted on the CMS website in December of 2016, additional technical
expert panel and clinical workgroup webinars were held after the
posting of the technical report, and a National Provider call occurred
in January 2017
[[Page 32385]]
to further solicit feedback from stakeholders and the general
public.\27\ \28\ As noted above, the CY 2018 HH PPS proposed rule
further solicited comments on an alternative case-mix adjustment
methodology. Ultimately the proposed alternative case-mix adjustment
methodology, including a proposed change in the unit of payment from 60
days to 30 days, was not finalized in the CY 2018 HH PPS final rule in
order to allow CMS additional time to consider public comments for
potential refinements to the model (82 FR 51676).
---------------------------------------------------------------------------
\27\ Abt Associates. ``Overview of the Home Health Groupings
Model.'' Medicare Home Health Prospective Payment System: Case-Mix
Methodology Refinements. Cambridge, MA, November 18, 2016. Available
at https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
\28\ Centers for Medicare & Medicaid Services (CMS).
``Certifying Patients for the Medicare Home Health Benefit.'' MLN
ConnectsTM National Provider Call. Baltimore, MD,
December 16, 2016. Slides, examples, audio recording and transcript
available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2017-01-18-Home-Health.html?DLPage=2&DLEntries=10&DLSort=0&DLSortDir=descending.
---------------------------------------------------------------------------
On February 1, 2018, CMS convened another TEP, to gather
perspectives and identify and prioritize recommendations from industry
leaders, clinicians, patient representatives, and researchers with
experience with home health care and/or experience in home health
agency management regarding the case-mix adjustment methodology
refinements described in the CY 2018 HH PPS proposed rule (82 FR
35270), and alternative case-mix models submitted during 2017 as
comments to the CY 2018 HH PPS proposed rule. During the TEP, there was
a description and solicitation of feedback on the components of the
proposed case-mix methodology refinement, such as resource use, 30-day
periods, clinical groups, functional levels, comorbidity groups, and
other variables used to group periods into respective case-mix groups.
Also discussed were the comments received from the CY 2018 HH PPS
proposed rule, the creation of case-mix weights, and an open discussion
to solicit feedback and recommendations for next steps. This TEP
satisfied the requirement set forth in section 51001(b)(1) of the BBA
of 2018, which requires that at least one session of such a TEP be held
between January 1, 2018 and December 31, 2018. Lastly, section
51001(b)(3) of the BBA of 2018 requires the Secretary to issue a report
to the Committee on Ways and Means and Committee on Energy and Commerce
of the House of Representatives and the Committee on Finance of the
Senate on the recommendations from the TEP members, no later than April
1, 2019. This report is available on the CMS HHA Center web page at:
https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html and satisfies the requirement of section 51001(b)(3) of the
BBA of 2018.
Finally, with respect to comments regarding the availability of
data to replicate and model the effects of the PDGM on HHAs, we note
that generally the data needed to replicate and model the effects of
the proposed PDGM are available by request through the CMS Data Request
Center.\29\ Although claims data for home health are available on a
quarterly and annual basis as Limited Data Set (LDS) files and Research
Identifiable Files (RIFs); we note that assessment data (OASIS) are not
available as LDS files through the CMS Data Request Center. While CMS
is able to provide LDS files in a more expedited manner, it may take
several months for CMS to provide RIFs. Therefore, we will provide upon
request a Home Health Claims-OASIS LDS file to accompany the CY 2019 HH
PPS proposed and final rules. We believe that in making a Home Health
Claims-OASIS LDS file available upon request in conjunction with the CY
2019 HH PPS proposed and final rules, this would address concerns from
stakeholders regarding data access and transparency in annual
ratesetting.
---------------------------------------------------------------------------
\29\ https://www.resdac.org/cms-data/request/cms-data-request-center.
---------------------------------------------------------------------------
The Home Health Claims-OASIS LDS file can be requested by following
the instructions on the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/Data-Disclosures-Data-Agreements/DUA_-_NewLDS.html and a file layout will be available.
This file will contain information from claims data matched with
assessment data for CY 2017, both obtained from the Chronic Conditions
Data Warehouse (CCW), and each observation in the file will represent a
30-day period of care with variables created that provide information
corresponding to both the 30-day period of care and the 60-day episode
of care. The file will also contain variables that show the case-mix
group that a particular claim would be grouped into under both the new
PDGM case-mix methodology and the current case-mix adjustment
methodology as well as variables for all the assessment items used for
grouping the claim into its appropriate case-mix group under the PDGM
and variables used for calculating resource use. Because this Home
Health Claims-OASIS LDS file includes variables used for calculating
resource use, this file will also include publically available data
from home health cost reports and the BLS. Some of the cost data in
this file is trimmed and imputed before being used as outlined above.
We note that much of the content of the Home Health Claims-OASIS LDS
file will be derived from CMS data sources. That is, many elements of
claims or elements of OASIS will not be copied to the LDS file as is.
For example, we will have variables in the data files that will record
the aggregated number of visits and minutes of service by discipline
type. We will need to create those aggregates from the line item data
available on the claims data. Because we will be taking data from
different sources (claims, OASIS, and cost reports/BLS), we will match
the data across those sources. Information from claims and costs
reports will be linked using the CCN. OASIS assessment data will be
linked to those sources using information available both on the claim
and OASIS. As noted earlier in this section, any episodes that could
not be linked with an OASIS assessment were excluded from the analysis
file, as they included insufficient patient-level data to re-group such
episodes into one of the 216 case-mix groups under the PDGM.
In addition, similar to the CY 2018 HH PPS proposed rule, we will
again provide a PDGM Grouper Tool in conjunction with this proposed
rule on CMS' HHA Center web page to allow HHAs to replicate the PDGM
methodology using their own internal data.\30\ In addition, in
conjunction with this proposed rule, we will post a file on the HHA
Center web page that contains estimated Home Health Agency-level
impacts as a result of the proposed PDGM.
---------------------------------------------------------------------------
\30\ https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html.
---------------------------------------------------------------------------
2. Methodology Used To Calculate the Cost of Care
To construct the case-mix weights for the PDGM proposal, the costs
of providing care needed to be determined. A Wage-Weighted Minutes of
Care (WWMC) approach is used in the current payment system based on
data from the BLS. However, we are proposing to adopt a Cost-per-Minute
plus Non-Routine Supplies (CPM + NRS) approach, which uses information
from HHA Medicare Cost Reports and Home Health Claims.
Home Health Medicare Cost Report Data: All Medicare-
certified HHAs must report their own costs through publicly-
[[Page 32386]]
available home health cost reports maintained by the Healthcare Cost
Report Information System (HCRIS). Freestanding HHAs report using a
HHA-specific cost report while HHAs that are hospital-based report
using the HHA component of the hospital cost reports. These cost
reports enable estimation of the cost per visit by provider and the
estimated NRS cost to charge ratios. To obtain a more robust estimate
of cost, a trimming process was applied to remove cost reports with
missing or questionable data and extreme values.\31\
---------------------------------------------------------------------------
\31\ The trimming methodology is described in the report
``Analyses in Support of Rebasing & Updating Medicare Home Health
Payment Rates'' (Morefield, Christian, and Goldberg 2013). See
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/Analyses-in-Support-of-Rebasing-and-Updating-the-Medicare-Home-Health-Payment-Rates-Technical-Report.pdf.
---------------------------------------------------------------------------
Home Health Claims Data: Medicare home health claims data
are used in both the previous WWMC approach and in the CPM+NRS method
to obtain minutes of care by discipline of care.
Under the proposed PDGM, we group 30-day periods of care into their
case-mix groups taking into account admission source, timing, clinical
group, functional level, and comorbidity adjustment. From there, the
average resource use for each case-mix group dictates the group's case-
mix weight. We propose that resource use be estimated with the cost of
visits recorded on the home health claim plus the cost of NRS recorded
on the claims. The cost of NRS is generated by taking NRS charges on
claims and converting them to costs using a NRS cost to charge ratio
that is specific to each HHA. NRS costs are then added to the resource
use estimates. That overall resource use estimate is then used to
establish the case-mix weights. Similar to the current system, NRS
would still be paid prospectively under the PDGM, but the PDGM
eliminates the separate case-mix adjustment model for NRS.
Under the proposed alternative case-mix methodology discussed in
the CY 2018 HH PPS proposed rule, we proposed to calculate resource use
using the CPM+NRS approach (82 FR 35270). In response to the CY 2018 HH
PPS proposed rule, several commenters expressed support for the
proposed change to the CPM+NRS methodology used to measure resource
use, noting that such an approach incorporates a wider variety of costs
(such as transportation) compared to the current WWMC approach.
Alternatively, other commenters responding to last year's proposed rule
objected to using Medicare cost report data rather than Wage-Weighted
Minutes of Care (WWMC) to calculate resource use. The commenters
indicated that the strength and utility of period-specific cost depends
on the accuracy and consistency of agencies' reported charges, cost-to-
charge ratios, and period minutes and indicated that they believe there
are no incentives for ensuring the accuracy of HHA cost reports, which
they believe may result in erroneous data. Several commenters also
indicated that the use of cost report data in lieu of WWMC favors
facility-based agencies because they believe that facility-based
agencies have the ability to allocate indirect overhead costs from
their parent facilities to their service cost and argued that the
proposed alternative case-mix methodology would reward inefficient HHAs
with historically high costs. A few commenters stated that Non-Routine
Supplies (NRS) should not be incorporated into the base rate and then
wage-index adjusted (as would be the case if CMS were to use the
CPM+NRS approach to estimate resource use). The commenters stated that
HHAs' supply costs are approximately the same nationally, regardless of
rural or urban locations and regardless of the wage-index, and
including NRS in the base rate will penalize rural providers and
unnecessarily overpay for NRS in high wage-index areas. We note that in
accordance with the requirement of section 51001 of the BBA of 2018, a
Technical Expert Panel (TEP) convened in February 2018 to solicit
feedback and identify and prioritize recommendations from a wide
variety of industry experts and patient representatives regarding the
public comments received on the proposed alternative case-mix
adjustment methodology. We received similar comments on the approach to
calculating resource use using the CPM+NRS approach, versus the WWMC
approach, bothin response to the CY 2018 HH PPS proposed rule and those
provided by the TEP participants.
We believe that using HHA Medicare cost report data, through the
CPM+NRS approach, to calculate the costs of providing care better
reflects changes in utilization, provider payments, and supply amongst
Medicare-certified HHAs. Using the BLS average hourly wage rates for
the entire home health care service industry does not reflect changes
in Medicare home health utilization that impact costs, such as the
allocation of overhead costs when Medicare home health visit patterns
change. Utilizing data from HHA Medicare cost reports better represents
the total costs incurred during a 30-day period (including, but not
limited to, direct patient care contract labor, overhead, and
transportation costs), while the WWMC method provides an estimate of
only the labor costs (wage and fringe benefit costs) related to direct
patient care from patient visits that are incurred during a 30-day
period. With regards to accuracy, we note that each HHA Medicare cost
report is required to be certified by the Officer or Director of the
home health agency as being true, correct, and complete with potential
penalties should any information in the cost report be a
misrepresentation or falsification of information.
As noted above, and in the CY 2018 HH PPS proposed rule, we applied
the trimming methodology described in detail in the ``Analyses in
Support of Rebasing & Updating Medicare Home Health Payment Rates''
Report. This is also the trimming methodology outlined in the CY 2014
HH PPS proposed rule (78 FR 40284) in determining the rebased national,
standardized 60-day episode payment amount. For each discipline and for
NRS used in calculating resource use using the CPM+NRS approach, we
also followed the methodology laid out in the ``Rebasing Report'' by
trimming out values that fall in the top or bottom 1 percent of the
distribution across all HHAs. This included the cost per visit values
for each discipline and NRS cost-to-charge ratios that fall in the top
or bottom 1 percent of the distribution across all HHAs. Normalizing
data by trimming out missing or extreme values is a widely accepted
methodology both within CMS and amongst the health research community
and provides a more robust measure of average costs per visit that is
reliable for the purposes of establishing base payment amounts and
case-mix weights under the HH PPS. Using HHA Medicare cost report data
to establish the case-mix weight aligns with the use of this data in
determining the national, standardized 60-day episode payment amount
under the HH PPS.
In response to commenters' concerns regarding the allocation of
overhead costs by facility-based HHAs, we note that a single HHA's
costs impact only a portion of the calculation of the weights and costs
are blended together across all HHAs. The payment regression was
estimated using 8,624,776 30-day periods from 10,480 providers. On
average, each provider contributed 823 30-day periods to the payment
regression, which is only 0.010 percent of all 30-day periods.
Therefore, including or excluding any single HHA, on average, would not
dramatically
[[Page 32387]]
impact the results of the payment regression. Further, facility-based
HHAs are only 8 percent of HHAs whereas 92 percent of HHAs are
freestanding, and coincidentally the percentage of 30-day periods
furnished by facility-based versus freestanding HHAs is also 8 and 92
percent, respectively. Additionally, in the PDGM, we estimate the
payment regression using provider-level fixed effects; therefore we are
looking at the within provider variation in resource use.
In the CY 2008 HH PPS final rule, CMS noted that use of non-routine
medical supplies is unevenly distributed across episodes of care in
home health. In addition, the majority of episodes do not incur any NRS
costs and, at that time, the current payment system overcompensated for
episodes with no NRS costs. In the CY 2008 HH PPS proposed rule, we
stated that patients with certain conditions, many of them related to
skin conditions, were more likely to require high non-routine medical
supply utilization (72 FR 49850), and that we would continue to look
for ways to improve our approach to account for NRS costs and payments
in the future (72 FR 25428). We believe that the proposed PDGM offers
an alternative method for accounting for NRS costs and payments by
grouping patients more likely to require high NRS utilization. For
example, while the Wound group and Complex Nursing Interventions groups
comprise about 9 percent and 4 percent of all 30-day periods of care,
respectively; roughly 27 percent of periods where NRS was supplied were
assigned to the Wound and Complex Nursing Interventions groups and 44
percent of NRS costs fall into the Wound and Complex Nursing groups. We
note that CY 2017 claims data indicates that about 60 percent of 60-day
episodes did not provide any NRS.
In using the CPM + NRS approach to calculate the cost of proving
care (resource use), NRS costs are reflected in the average resource
use that drives the case-mix weights. If there is a high amount of NRS
cost for all periods in a particular group (holding all else equal),
the resource use for those periods will be higher relative to the
overall average and the case-mix weight will correspondingly be higher.
Similar to the current system, NRS would still be paid prospectively
under the PDGM, but the PDGM eliminates the separate case-mix
adjustment model for NRS. Incorporating the NRS cost into the measure
of overall resource use (that is, the dependent variable of the payment
model) requires adjusting the NRS charges submitted on claims based on
the NRS cost-to-charge ratio from cost report data.
The following steps would be used to generate the measure of
resource use under this CPM + NRS approach:
(1) From the cost reports, obtain total costs for each of the six
home health disciplines for each HHA.
(2) From the cost reports, obtain the number of visits by each of
the six home health disciplines for each HHA.
(3) Calculate discipline-specific cost per visit values by dividing
total costs [1] by number of visits [2] for each discipline for each
HHA. For HHAs that did not have a cost report available (or a cost
report that was trimmed from the sample), imputed values were used as
follows:
A state-level mean was used if the HHA was not hospital-
based. The state-level mean was computed using all non-hospital based
HHAs in each state.
An urban nationwide mean was used for all hospital-based
HHAs located in a Core-based Statistical Area (CBSA). The urban nation-
wide mean was computed using all hospital-based HHAs located in any
CBSA.
A rural nationwide mean was used for all hospital-based
HHAs not in a CBSA. The rural nation-wide mean was computed using all
hospital-based HHAs not in a CBSA.
(4) From the home health claims data, obtain the average number of
minutes of care provided by each discipline across all episodes for a
HHA.
(5) From the home health claims data, obtain the average number of
visits provided by each discipline across all episodes for each HHA.
(6) Calculate a ratio of average visits to average minutes by
discipline by dividing average visits provided [5] by average minutes
of care [4] by discipline for each HHA.
(7) Calculate costs per minute by multiplying the HHA's cost per
visit [3] by the ratio of average visits to average minutes [6] by
discipline for each HHA.
(8) Obtain 30-day period costs by multiplying costs per minute [7]
by the total number of minutes of care provided during a 30-day period
by discipline. Then, sum these costs across the disciplines for each
period.
This approach accounts for variation in the length of a visit by
discipline. NRS costs are added to the resource use calculated in [8]
in the following way:
(9) From the cost reports, determine the NRS cost-to-charge ratio
for each HHA. The NRS ratio is trimmed if the value falls in the top or
bottom 1 percent of the distribution across all HHAs from the trimmed
sample. Imputation for missing or trimmed values is done in the same
manner as it was done for cost per visit (see [3] above).
(10) From the home health claims data, obtain NRS charges for each
period.
(11) Obtain NRS costs for each period by multiplying charges from
the home health claims data [10] by the cost-to-charge ratio from the
cost reports [9] for each HHA.
Resource use is then obtained by:
(12) Summing costs from [8] with NRS costs from [11] for each 30-
day period.
Table 31 shows these costs for 30-day periods in CY 2017 (n =
8,624,776). On average, total 30-day period costs as measured by
resource use are $1,570.68. The distribution ranges from a 5th
percentile value of $296.66 to a 95th percentile value of $3,839.91.
Table 31--Distribution of Average Resource Use Using CPM + NRS Approach
[30 Day periods]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
5th 10th 25th 50th 75th 90th 95th
Statistics Mean N Percentile Percentile Percentile Percentile Percentile Percentile Percentile
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Average Resource Use (CPM + NRS).................................. $1,570.68 8,624,776 $296.66 $394.31 $679.12 $1,272.18 $2,117.47 $3,107.93 $3,839.91
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The distributions and magnitude of the estimates of costs for the
CPM + NRS method versus the WWMC method are very different. The
differences arise because the CPM + NRS method incorporates HHA-
specific costs that represent the total costs incurred during a 30-day
period (including overhead costs), while the WWMC method provides an
estimate of only the labor costs (wage + fringe) related to direct
patient care from patient visits that are incurred during a 30-day
period. Those costs are not HHA-specific and do not account for any
non-labor costs (such as
[[Page 32388]]
transportation costs) or the non-direct patient care labor costs (such
as, administration and general labor costs). Because the costs
estimated using the two approaches are measuring different items, they
cannot be directly compared. However, if the total cost of a 30-day
period is correlated with the labor that is provided during visits, the
two approaches should be highly correlated. The correlation coefficient
(estimated by comparing a 30-day period's CPM + NRS resource use to the
same period's WWMC resource use) between the two approaches to
calculating resource use is equal to 0.8512 (n = 8,624,776). Therefore,
the relationship in relative costs is similar between the two methods.
Using cost report data to develop case-mix weights more evenly
weights skilled nursing services and therapy services than the BLS
data. Table 32 shows the ratios between the estimated costs per hour
for each of the home health disciplines compared with skilled nursing
resulting from the CPM + NRS versus WWMC methods. Under the CPM + NRS
methodology, the ratio for physical therapy costs per hour to skilled
nursing is 1.14 compared with 1.36 using the WWMC method.
Table 32--Relative Values in Costs per Hour by Discipline
[Skilled nursing is base]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Skilled Physical Occupational Medical social Home health
Estimated cost per hour nursing therapy therapy Speech therapy service aide
--------------------------------------------------------------------------------------------------------------------------------------------------------
CPM + NRS............................................... 1.00 1.14 1.15 1.25 1.39 0.40
WWMC.................................................... 1.00 1.36 1.38 1.56 0.94 0.35
--------------------------------------------------------------------------------------------------------------------------------------------------------
In response to the CY 2018 HH PPS proposed rule (82 FR 35270), a
few commenters, stated that based on their operational experiences with
clinical staffing labor costs, HHA cost report data suggests more
parity exists between skilled nursing (``SN'') versus physical
therapist (``PT'') costs than in fact exists. Commenters stated that
BLS data showing a 40 percent difference between SN and PT costs are
more reflective of the human resources experiences in the markets where
they operate. As such, commenters believe the use of cost report data
would cause the proposed alternative case-mix methodology to overpay
for nursing services and underpay for therapy services, although it was
not clear from the comments why the relative relationship in cost
between disciplines would necessarily mean that nursing would be
overpaid or underpaid relative to therapy.
We note that the HHA Medicare cost report data reflects all labor
costs, including contract labor costs. The BLS data only reflects
employed staff. This may partially explain why a 40 percent variation
between SN and PT costs is not evident in the cost report data.
However, the comparison is somewhat inappropriate because the BLS data
only reflects labor costs whereas the HHA Medicare cost report data
includes labor and non-labor costs. As noted earlier in Table 32, there
is only a 14 percent variation using the CPM + NRS methodology.
Moreover, in aggregate, about 15 percent of compensation costs are
contract labor costs and this varies among the disciplines with
contract labor costs accounting for a much higher proportion of therapy
visit costs compared to skilled nursing visit costs. Utilization also
varies among freestanding providers with smaller providers having a
higher proportion of contract labor costs, particularly for therapy
services compared to larger providers. The decision of whether to/or
what proportion of contract labor to use is at the provider's
discretion. Finally, we note that in order to be eligible for Medicare
HH PPS payments, providers must complete the HHA Medicare cost report
and certify the report by the Officer or Director of the home health
agency as being true, correct, and complete; therefore, such data can
and should be used to calculate the cost of care.
We have determined that using cost report data to calculate the
cost of home health care better aligns the case-mix weights with the
total relative cost for treating various patients. In addition, using
cost report data allows us to incorporate NRS into the case-mix system,
rather than maintaining a separate payment system. Therefore, we are
re-proposing to calculate the cost of a 30-day period of home health
care under the proposed PDGM using the cost per minute plus non-routine
supplies (CPM + NRS) approach outlined above, as also outlined in the
CY 2018 proposed rule. We invite comments on the proposed methodology
for calculating the cost of a 30-day period of care under the PDGM.
3. Change From a 60-Day to a 30-Day Unit of Payment
a. Background
Currently, HHAs are paid for each 60-day episode of home health
care provided. In the CY 2018 HH PPS proposed rule, CMS proposed a
change from making payment based on 60-day episodes to making payment
based on 30-day periods, effective for January 1, 2019. Examination of
the resources used within a 60-day episode of care identified
differences in resources used between the first 30-day period within a
60-day episode and the second 30-day period within a 60-day episode.
Episodes have more visits, on average, during the first 30 days
compared to the last 30 days and costs are much higher earlier in the
episode and lesser later on; therefore, dividing a single 60-day
episode into two 30-day periods more accurately apportioned payments.
In addition, with the proposed removal of therapy thresholds from the
case-mix adjustment methodology under the HH PPS, a shorter period of
care reduced the variation and improved the accuracy of the case-mix
weights generated under the PDGM. CMS did not finalize the
implementation of a 30-day unit of payment in the CY 2018 HH PPS final
rule (82 FR 51676).
Section 1895(b)(2)(B) of the Act, as added by section 51001(a)(1)
of the BBA of 2018, requires the Secretary to apply a 30-day unit of
service for purposes of implementing the HH PPS, effective January 1,
2020. We note that we interpret the term ``unit of service'' to be
synonymous with ``unit of payment'' and will henceforth refer to ``unit
of payment'' in this proposed rule with regards to payment under the HH
PPS. We propose to make HH payments based on a 30-day unit of payment
effective January 1, 2020. While we are proposing to change to a 30-day
unit of payment, we note that the comprehensive assessment would still
be completed within 5 days of the start of care date and completed no
less frequently than during the last 5 days of every 60 days beginning
with the start of care date, as currently required by Sec. 484.55,
Condition of participation: Comprehensive assessment of patients.
[[Page 32389]]
In addition, the plan of care would still be reviewed and revised by
the HHA and the physician responsible for the home health plan of care
no less frequently than once every 60 days, beginning with the start of
care date, as currently required by Sec. 484.60(c), Condition of
participation: Care planning, coordination of services, and quality of
care.
b. 30-Day Unit of Payment
Under section 1895(b)(3)(A)(iv) of the Act, we are required to
calculate a 30-day payment amount for CY 2020 in a budget neutral
manner such that estimated aggregate expenditures under the HH PPS
during CY 2020 are equal to the estimated aggregate expenditures that
otherwise would have been made under the HH PPS during CY 2020 in the
absence of the change to a 30-day unit of payment. Furthermore, as also
required by section 1895(b)(3)(A)(iv) of the Act, to calculate a 30-day
payment amount in a budget-neutral manner, we are required to make
assumptions about behavior changes that could occur as a result of the
implementation of the 30-day unit of payment. In addition, in
calculating a 30-day payment amount in a budget-neutral manner, we must
take into account behavior changes that could occur as a result of the
case-mix adjustment factors that are implemented in CY 2020. We are
also required to calculate a budget-neutral 30-day payment amount
before the provisions of section 1895(b)(3)(B) of the Act are applied,
that is, the home health applicable percentage increase, the adjustment
for case-mix changes, the adjustment if quality data is not reported,
and the productivity adjustment.
In calculating the budget-neutral 30-day payment amount, we propose
to make three assumptions about behavior change that could occur in CY
2020 as a result of the implementation of the 30-day unit of payment
and the implementation of the PDGM case-mix adjustment methodology
outlined in this proposed rule:
Clinical Group Coding: A key component of determining
payment under the PDGM is the 30-day period's clinical group
assignment, which is based on the principal diagnosis code for the
patient as reported by the HHA on the home health claim. Therefore, we
assume that HHAs will change their documentation and coding practices
and would put the highest paying diagnosis code as the principal
diagnosis code in order to have a 30-day period be placed into a
higher-paying clinical group. While we do not support or condone coding
practices or the provision of services solely to maximize payment, we
often take into account expected behavioral effects of policy changes
related to the implementation of the proposed rule.
Comorbidity Coding: The PDGM further adjusts payments
based on patients' secondary diagnoses as reported by the HHA on the
home health claim. While the OASIS only allows HHAs to designate 1
primary diagnosis and 5 secondary diagnoses, the home health claim
allows HHAs to designate 1 principal diagnosis and 24 secondary
diagnoses. Therefore, we assume that by taking into account additional
ICD-10-CM diagnosis codes listed on the home health claim (beyond the 6
allowed on the OASIS), more 30-day periods of care will receive a
comorbidity adjustment than periods otherwise would have received if we
only used the OASIS diagnosis codes for payment. The comorbidity
adjustment in the PDGM can increase payment by up to 20 percent.
LUPA Threshold: Rather than being paid the per-visit
amounts for a 30-day period of care subject to the low-utilization
payment adjustment (LUPA) under the proposed PDGM, we assume that for
one-third of LUPAs that are 1 to 2 visits away from the LUPA threshold
HHAs will provide 1 to 2 extra visits to receive a full 30-day
payment.\32\ LUPAs are paid when there are a low number of visits
furnished in a 30-day period of care. Under the PDGM, the LUPA
threshold ranges from 2-6 visits depending on the case-mix group
assignment for a particular period of care (see section F.9 of this
proposed rule for the LUPA thresholds that correspond to the 216 case-
mix groups under the PDGM).
---------------------------------------------------------------------------
\32\ Current data suggest that what would be about \1/3\ of the
LUPA episodes with visits near the LUPA threshold move up to become
non-LUPA episodes. We assume this experience will continue under the
PDGM, with about \1/3\ of those episodes 1 or 2 visits below the
thresholds moving up to become non-LUPA episodes.
---------------------------------------------------------------------------
Table 33 includes estimates of what the 30-day payment amount would
be for CY 2019 (using CY 2017 home health utilization data) in order to
achieve budget neutrality both with and without behavioral assumptions
and including the application of the proposed home health payment
update percentage of 2.1 percent outlined in section C.2 of this
proposed rule. We note that these are only estimates to illustrate the
30-day payment amount if we had proposed to implement the 30-day unit
of payment and the proposed PDGM for CY 2019. However, because we are
proposing to implement the 30-day unit of payment and proposed PDGM for
CY 2020, we would propose the actual 30-day payment amount in the CY
2020 HH PPS proposed rule calculated using CY 2018 home health
utilization data, and we would calculate this amount before application
of the proposed home health update percentage required for CY 2020 (as
required by section 1895(b)(3)(iv) of the Act). In order to calculate
the budget neutral 30-day payment amounts in this proposed rule, both
with and without behavioral assumptions, we first calculated the total,
aggregate amount of expenditures that would occur under the current
case-mix adjustment methodology (as described in section III.B. of this
rule) and the 60-day episode unit of payment using the proposed CY 2019
payment parameters (e.g., proposed 2019 payment rates, proposed 2019
case-mix weights, and outlier fixed-dollar loss ratio). That resulted
in a total aggregate expenditures target amount of $16.1 billion.\33\
We then calculated what the 30-day payment amount would need to be set
at in CY 2019, with and without behavior assumptions, while taking into
account needed changes to the outlier fixed-dollar loss ratio under the
PDGM in order to pay out no more than 2.5 percent of total HH PPS
payments as outlier payments (refer to section III.F.12 of this
proposed rule) and in order for Medicare to pay out $16.1 billion in
total expenditures in CY 2019 with the application of a 30-day unit of
payment under the PDGM.
---------------------------------------------------------------------------
\33\ The initial 2017 analytic file included 6,771,059 60-day
episodes ($18.2 billion in total expenditures). Of these, 959,410
(14.2 percent) were excluded because they could not be linked to
OASIS assessments or because of the claims data cleaning process
reasons listed in section III.F.1 of this proposed rule. We note
that of the 959,410 claims excluded, 620,336 were excluded because
they were RAPs without a final claim or they were claims with zero
payment amounts, resulting in $17.4 billion in total expenditures.
After removing all 959,410 excluded claims, the 2017 analytic file
consisted of 5,811,649 60-day episodes ($16.4 billion in total
expenditures). 60-day episodes of duration longer than 30 days were
divided into two 30-day periods in order to calculate the 30-day
payment amounts. As noted in section III.F.1 of this proposed rule,
there were instances where 30-day periods were excluded from the
2017 analytic file (for example, we could not match the period to a
start of care or resumption of care OASIS to determine the
functional level under the PDGM, the 30-day period did not have any
skilled visits, or because information necessary to calculate
payment was missing from claim record). The final 2017 analytic file
used to calculate budget neutrality consisted of 9,285,210 30-day
periods ($16.1 billion in total expenditures) drawn from 5,456,216
60-day episodes.
[[Page 32390]]
Table 33--Estimates of 30-Day Budget-Neutral Payment Amounts
------------------------------------------------------------------------
30-day budget Percent change
neutral (BN) from no
Behavioral assumption standard behavioral
amount assumptions
------------------------------------------------------------------------
No Behavioral Assumptions............... $1,873.91 ..............
LUPA Threshold (\1/3\ of LUPAs 1-2 1,841.05 -1.75
visits away from threshold get extra
visits and become case-mix adjusted)...
Clinical Group Coding (among available 1,793.69 -4.28
diagnoses, one leading to highest
payment clinical grouping
classification designated as principal)
Comorbidity Coding (assigns comorbidity 1,866.76 -0.38
level based on comorbidities appearing
on HHA claims and not just OASIS)......
Clinical Group Coding + Comorbidity 1,786.54 -4.66
Coding.................................
Clinical Group Coding + Comorbidity 1,753.68 -6.42
Coding + LUPA Threshold................
------------------------------------------------------------------------
If no behavioral assumptions were made, we estimate that the 30-day
payment amount needed to achieve budget neutrality would be $1,873.91.
The clinical group and comorbidity coding assumptions would result in
the need to decrease the budget-neutral 30-day payment amount to
$1,786.54 (a 4.66 percent decrease from $1,873.91). Adding the LUPA
assumption would require us to further decrease that amount to
$1,753.68 (a 6.42 percent decrease from $1,873.91).
We note that we are also required under section 1895(b)(3)(D)(i) of
the Act, as added by section 51001(a)(2)(B) of the BBA of 2018, to
analyze data for CYs 2020 through 2026, after implementation of the 30-
day unit of payment and new case-mix adjustment methodology, to
annually determine the impact of differences between assumed behavior
changes and actual behavior changes on estimated aggregate
expenditures. We interpret actual behavior change to encompass both
behavior changes that were outlined above, as assumed by CMS when
determining the budget-neutral 30-day payment amount for CY 2020, and
other behavior changes not identified at the time the 30-day payment
amount for CY 2020 is determined. The data from CYs 2020 through 2026
will be available to determine whether a prospective adjustment
(increase or decrease) is needed no earlier than in years 2022 through
2028 rulemaking. As noted previously, under section 1895(b)(3)(D)(ii)
of the Act, we are required to provide one or more permanent
adjustments to the 30-day payment amount on a prospective basis, if
needed, to offset increases or decreases in estimated aggregate
expenditures as calculated under section 1895(b)(3)(D)(i) of the Act.
Clause (iii) of section 1895(b)(3)(D) of the Act requires the Secretary
to make temporary adjustments to the 30-day payment amount, on a
prospective basis, in order to offset increases or decreases in
estimated aggregate expenditures, as determined under clause (i) of
such section. The temporary adjustments allow us to recover excess
spending or give back the difference between actual and estimated
spending (if actual is less than estimated) not addressed by permanent
adjustments. For instance, if expenditures are estimated to be $18
billion in CY 2020, but expenditures are actually $18.25 billion in CY
2020, then we can reduce payments (temporarily) in the future to
recover the $250 million.
As noted above, section 1895(b)(3)(A)(iv) of the Act requires the
Secretary to calculate a budget-neutral 30-day payment amount to be
paid for home health units of service that are furnished and end during
the 12-month period beginning January 1, 2020. For implementation
purposes, we propose that the 30-day payment amount would be paid for
home health services that start on or after January 1, 2020. More
specifically, for 60-day episodes that begin on or before December 31,
2019 and end on or after January 1, 2020 (episodes that would span the
January 1, 2020 implementation date), payment made under the Medicare
HH PPS would be the CY 2020 national, standardized 60-day episode
payment amount. For home health units of service that begin on or after
January 1, 2020, the unit of service would now be a 30-day period and
payment made under the Medicare HH PPS would be the CY 2020 national,
standardized prospective 30-day payment amount. For home health units
of service that begin on or after December 2, 2020 through December 31,
2020 and end on or after January 1, 2021, the HHA would be paid the CY
2021 national, standardized prospective 30-day payment amount.
We are soliciting comments on our proposals, including the proposed
behavior change assumptions outlined above to be used in determining
the 30-day payment amount for CY 2020 and the corresponding regulation
text changes outlined in section III.F.13 and IX. of this proposed
rule.
c. Split Percentage Payment Approach for a 30-Day Unit of Payment
In the current HH PPS, there is a split percentage payment approach
to the 60-day episode. The first bill, a Request for Anticipated
Payment (RAP), is submitted at the beginning of the initial episode for
60 percent of the anticipated final claim payment amount. The second,
final bill is submitted at the end of the 60-day episode for the
remaining 40 percent. For all subsequent episodes for beneficiaries who
receive continuous home health care, the episodes are paid at a 50/50
percentage payment split.
In the CY 2018 HH PPS proposed rule (82 FR 35270), we solicited
comments as to whether the split payment approach would still be needed
for HHAs to maintain adequate cash flow if the unit of payment changes
from 60-day episodes to 30-day periods of care. In addition, we
solicited comments on ways to phase-out the split percentage payment
approach in the future. Specifically, we solicited comments on reducing
the percentage of the upfront payment over a period of time and if in
the future the split percentage approach was eliminated, we solicited
comments on the need for HHAs to submit a notice of admission (NOA)
within 5 days of the start of care to assure being established as the
primary HHA for the beneficiary and so that the claims processing
system is alerted that a beneficiary is under a HH period of care to
enforce the consolidating billing edits as required by law. Commenters
generally expressed support for continuing the split percentage payment
approach in the future under the proposed alternative case-mix model.
While we solicited comments on the possibility of phasing-out the split
percentage payment approach in the future and the need for a NOA,
commenters did not provide suggestions for a phase-out approach, but
stated that they did not agree with requiring a NOA given the
[[Page 32391]]
experience with such a process under the Medicare hospice benefit.
While CMS did not finalize the implementation of a 30-day unit of
payment in the CY 2018 HH PPS final rule (82 FR 51676), the BBA of 2018
now requires a change to the unit of payment from a 60-day episode to a
30-day period of care, as outlined in section F.3.b above, effective
January 1, 2020. We continue to believe that as a result of the reduced
timeframe for the unit of payment, that a split percentage approach to
payment may not be needed for HHAs to maintain adequate cash flow.
Currently, about 5 percent of requests for anticipated payment are not
submitted until the end of a 60-day episode of care and the median
length of days for RAP submission is 12 days from the start of the 60-
day episode. As such, we are reevaluating the necessity of RAPs for
existing and newly-certified HHAs versus the risks they pose to the
Medicare program.
RAP payments can result in program integrity vulnerabilities. For
example, a final claim was never submitted for $321 million worth of
RAP payments between July 1, 2015 and July 31, 2016. While CMS
typically can recoup RAP overpayments from providers that continue to
submit final claims to the Medicare program, some fraud schemes have
involved collecting these RAP payments, never submitting final claims,
and closing the HHA before Medicare can take action. Below are two
examples of HHAs that were identified for billing large amounts of RAPs
with no final claim:
Provider 1 is a Home Health Agency located in Michigan. It
was identified for submitting home health claims for beneficiaries
located in California and Florida. Further analysis found that the HHA
was submitting RAPs with no final claims. CMS discovered that the
address on record for the HHA was vacant for an extended period of
time. In addition, CMS determined that although Provider 1 had
continued billing and receiving payments for RAP claims, it had not
submitted a final claim in 10 months. Ultimately, the HHA submitted a
total of $50,234,430.36 in RAP payments and received $37,204,558.80 in
RAP payments. In addition to the large amount of money paid to the HHA,
Medicare beneficiaries were also impacted by the HHA's billing
behavior. For example, a Florida beneficiary who needed home health
services was unable to receive the care required due to the RAP
submission by this Provider.
Provider 2 is a Home Health Agency that is also located in
Michigan that submitted a significant number of RAPs with no final
claim. While the majority of these beneficiaries were located in
Michigan, data analysis identified beneficiaries who were not likely
homebound or qualified for home health services. CMS discovered that
the address on record for the HHA was vacant. Provider 2 had not
submitted any final claims in more than one year and was no longer
billing the Medicare program. However, the HHA was paid a total of
$5,765,261.04 in RAP payments that had no final claim.
Given the program integrity concerns outlined above and the reduced
timeframe for the unit of payment (30-days rather than 60-days), we are
proposing not to allow newly-enrolled HHAs, that is HHAs certified for
participation in Medicare effective on or after January 1, 2019, to
receive RAP payments beginning in CY 2020. This would allow newly-
enrolled HHAs to structure their operations without becoming dependent
on a partial, advanced payment and take advantage of receiving full
payments for every 30-day period of care. We are proposing that HHAs,
that are certified for participation in Medicare effective on or after
January 1, 2019, would still be required to submit a ``no pay'' RAP at
the beginning of care in order to establish the home health episode, as
well as every 30-days thereafter. RAP submissions are currently
operationally significant as the RAP establishes the HHA as the primary
HHA for the beneficiary during that timeframe and alerts the claims
processing system that a beneficiary is under the care of an HHA to
enforce the consolidating billing edits required by law under section
1842(b)(6)(F) of the Act. Without such notification, there would be an
increase in denials of claims subject to the home health consolidated
billing edits that are prevented when an episode/period is established
in the common working file (CWF) by the RAP, potentially resulting in
increases in appeals, and increases in situations where other
providers, including other HHAs, would not have easy information on
whether a patient was already being served by an HHA. CMS invites
comments on whether the burden of submitting a ``no-pay'' RAP by newly-
enrolled HHAs outweighs the risks to the Medicare program and providers
associated with not submitting them.
We propose that existing HHAs, that is HHAs certified for
participation in Medicare with effective dates prior to January 1,
2019, would continue to receive RAP payments upon implementation of the
30-day unit of payment and the proposed PDGM case-mix adjustment
methodology in CY 2020. However, we are again soliciting comments on
ways to phase-out the split percentage payment approach in the future
given that CMS is required to implement a 30-day unit of payment
beginning on January 1, 2020 as outlined above. Specifically, we are
soliciting comments on reducing the percentage of the upfront payment
incrementally over a period of time. If in the future the split
percentage approach was eliminated, we are also soliciting comments on
the need for HHAs to submit a NOA within 5 days of the start of care to
assure being established as the primary HHA for the beneficiary during
that timeframe and so that the claims processing system is alerted that
a beneficiary is under a HH period of care to enforce the consolidating
billing edits as required by law. As outlined above, there are
significant drawbacks to both Medicare and providers of not
establishing a NOA process upon elimination of RAPs.
In summary, we invite comments on the change in the unit of payment
from a 60-day episode of care to a 30-day period of care; the proposed
calculation of the 30-day payment amount in a budget-neutral manner and
behavior change assumptions for CY 2020; the proposed interpretation of
the statutory language regarding actual behavior change; the proposal
not to allow newly-enrolled HHAs (HHAs certified for participation in
Medicare effective on or after January 1, 2019) to receive RAP payments
upon implementation of the 30-day unit of payment in CY 2020, yet still
require the submission of a ``no pay'' RAP at the beginning of care;
the proposal to maintain the split percentage payment approach for
existing HHAs and applying such policy to 30-day periods of care; and
the associated regulations text changes outlined in section III.F.13
and IX of this proposed rule. We are also soliciting comments on ways
the split percentage payment approach could be phased-out and whether
to implement a NOA process if the split percentage payment approach is
eliminated in the future.
4. Timing Categories
In the CY 2018 HH PPS proposed rule, we described analysis showing
the impact of timing on home health resource use and proposed to
classify the 30-day periods under the proposed alternative case-mix
adjustment methodology as ``early'' or ``late'' depending on when they
occur within a sequence of 30-day periods (82 FR 35307). Under the
current HH PPS, the first two 60-day episodes of a sequence of adjacent
60-day episodes are considered early, while the third 60-day
[[Page 32392]]
episode of that sequence and any subsequent episodes are considered
late. Under the alternative case-mix adjustment methodology, we
proposed that the first 30-day period would be classified as early and
all subsequent 30-day periods in the sequence (second or later) would
be classified as late. Similar to the current payment system, we
proposed that a 30-day period could not be considered early unless
there was a gap of more than 60 days between the end of one period and
the start of another, or it was the first period in a sequence of
periods in which there was no more than 60 days between the end of that
period and the start of the next period.
In response to the CY 2018 HH PPS proposed rule, several commenters
were supportive of the inclusion of the timing category in the
alternative case-mix adjustment methodology, stating that this
differentiation would reflect that HHA costs are typically highest
during the first 30 days of care. However, other commenters expressed
concerns regarding timing, stating that HHAs may modify the ways in
which they provide care, that the change would cause a decrease in
overall payment to HHAs and an increase in hospital readmissions, and
that the categories would not account for increased costs in the later
periods of care. Several commenters described concerns regarding the
potential for problematic provider behavior due to financial incentives
as well as the potential for problems with operational aspects of the
timing element of the alternative case-mix adjustment methodology.
Additionally, some commenters suggested that we modify the definition
of an ``early'' 30-day period to either the first two 30-day periods or
the first four 30-days of care, stating that those definitions would
more closely mirror the current payment system's definition of
``early'' and that HHAs would otherwise experience a payment decrease
when compared to the current 60-day episode payment amount.
As described in detail in the CY 2018 HH PPS proposed rule, our
proposal regarding the timing element of the alternative case-mix
adjustment methodology was intended to refine and to better fit costs
incurred by agencies for patients with differing characteristics and
needs under the HH PPS (82 FR 35270). Analysis of home health data
demonstrates that under the current payment system, when analyzed by
30-day periods, HHAs provide more resources in the first 30-day period
of home health (``early'') than in later periods of care. The
differences in the average resource use during early and late home
health episodes when divided into 30-day periods are presented in Table
34, and shows the first 30-day periods in a home health sequence have
significantly higher average resource use at $2,113.66 as compared with
subsequent 30-day periods. Specifically, the later 30-day periods
showed an average resource use of $1,311.73, a difference of more than
$800 or a 38 percent decrease. Table 34 also shows a significant
difference between the early and late median values of resource use.
The median for the first 30-day period is $1,866.79, while the median
for subsequent 30-day periods is $987.94, a difference of more than
$878 or an approximately 47 percent decrease.
Table 34--Average Resource Use by Timing
[30-Day periods]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Average Frequency Percent of deviation percentile Median percentile
Timing resource of periods periods of resource of resource resource of resource
use use use use use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early 30-Day Periods......................................... $2,113.66 2,785,039 32.3 $1,236.30 $1,232.23 $1,866.79 $2,707.04
Late 30-Day Periods.......................................... 1,311.73 5,839,737 67.7 1,125.44 534.82 987.94 1,735.69
------------------------------------------------------------------------------------------
Total.................................................... 1,570.68 8,624,776 100.0 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
There is significant difference in the resource utilization between
early and late 30-day periods as demonstrated in Table 34. Moreover,
the predictive power of the proposed PDGM in terms of estimating
resource utilization improved when separating episodes into 30-day
periods rather than 60-day periods (that is, the first and second 30-
day periods). We believe that a PDGM that accounts for the demonstrated
increase in resource utilization in the first 30-day period better
captures the variations in resource utilization and further promotes
the goal of payment accuracy within the HH PPS.
Moreover, we note that the resource cost estimates are derived from
a very large, representative dataset. Therefore, we expect that the
proposal reflects agencies' average costs for all home health service
delivered in the period examined. We have constructed the revised case-
mix adjustment model based upon the actual resources expended by home
health agencies for Medicare beneficiaries, which show that typically
HHAs provide more visits during the first 30 days of care and utilize
less resources thereafter. We reiterate that the timing categories are
reflective of the utilization patterns observed in the data analyzed
for the purposes of constructing the PDGM. The weights of the two
timing categories are driven by the mix of services provided, the costs
of services provided as determined by cost report data, the length of
the visits, and the number of visits provided. The categorization of
30-day periods as ``early'' and ``late'' serves to better align
payments with already existing resource use patterns. This alignment of
payment with resource use is not to be interpreted as placing a value
judgment on particular care patterns or patient populations. Our goal
in developing the PDGM is to provide an appropriate payment based on
the identified resource use of different patient groups, not to
encourage, discourage, value, or devalue one type of skilled care over
another.
For the reasons described above, we are proposing to classify the
30-day periods under the proposed PDGM as ``early'' or ``late''
depending on when they occur within a sequence of 30-day periods. For
the purposes of defining ``early'' and ``late'' periods for the
proposed PDGM, we are proposing that only the first 30-day period in a
sequence of periods be defined as ``early'' and all other subsequent
30-day periods would be considered ``late''. Additionally, we are
proposing that the definition of a ``home health sequence'' (as
currently described in Sec. 484.230) will remain unchanged relative to
the current system, that is, 30-day periods are considered to be in the
same sequence as long as no more than 60 days pass between the end of
one period and the start of the next, which is consistent with the
definition of a ``home health spell of illness'' described at section
1861(tt)(2) of the Act. We note
[[Page 32393]]
that because section 1861(tt)(2) of the Act is a definition related to
eligibility for home health services as described at section 1812(a)(3)
of the Act, it does not affect or restrict our ability to implement a
30-dayunit of payment.
At this time, the data do not support the notion that the first two
30-day periods should be defined as early, as only the first 30-day
period presents marked increase in resource use. We believe the PDGM's
definition of ``early'' as the first 30-day period most accurately
reflects agencies' average costs for patients with characteristics
measured on the OASIS and used in defining payment groups and supports
the shift from the current ``early'' category as defined by two 60-day
episodes. We continue to believe that a PDGM that accounts for the
actual, demonstrated increase in resource utilization in the first 30-
day period better captures the variations in resource utilization.
Additionally, in our CY 2008 HH PPS final rule, we implemented an
``early'' and ``late'' distinction in the HH PPS in which the late
episode groupings were weighted more heavily than those episodes
designated as early due to heavier resource use during later episodes
(72 FR 49770). At that time, commenters expressed concerns that this
heavier weighting for later episodes could lead to gaming by providers,
with patients on service longer than would be appropriate, and
providers not discharging patients when merited. During our analysis in
support of subsequent refinements to the HH PPS in 2015, we analyzed
the utilization patterns observed in the CY 2013 claims data and
observed that the resource use for later episodes had indeed shifted
such that later episodes had less resource use than earlier periods,
which was the opposite of the pattern observed prior to CY 2008.
Furthermore, in its 2016 Report to Congress, MedPAC noted that, between
2002 and 2014, a pattern in home health emerged where the number of
episodes of care provided to home health beneficiaries trended upwards,
with the average number of episodes per user increasing by 18 percent,
rising from 1.6 to 1.9 episodes per user.\34\ MedPAC noted that this
upward trajectory coincided with, among other changes, higher payments
for the third and later episodes in a consecutive spell of home health
episodes. Given the longitudinal variation in terms of resource
provision during home health episodes, we believe that restricting the
``early'' definition to the first 30-day period is most appropriate for
this facet of the PDGM. Our analysis of home health resource use as
well as comments from the public that confirm that more resources are
provided in the first 30 days provide compelling evidence to limit the
definition of early to the first 30-day period.
---------------------------------------------------------------------------
\34\ http://www.medpac.gov/docs/default-source/reports/chapter-8-home-health-care-services-march-2016-report-.pdf.
---------------------------------------------------------------------------
Moreover, the public comments we received in response to the CY
2018 HH PPS proposed rule presented conflicting predictions regarding
anticipated provider behavior in response to the implementation of the
alternative case-mix adjustment methodology. Several commenters stated
that they expected providers to discharge patients after the first 30-
days of care, given that the case-mix weights are, on average, higher
for the first 30-days of care. Other commenters expressed concern that
providers may attempt to keep home health beneficiaries on service for
as long as possible. Additionally, meeting the requirement of section
51001 of the BBA of 2018, a Technical Expert Panel (TEP) was convened
in February 2018 to solicit feedback and identify and prioritize
recommendations from a wide variety of industry experts and patient
representatives regarding the public comments received on the proposed
alternative case-mix adjustment methodology. Comments on the timing
categories and suggestions for refinement to this adjustment were very
similar between those received on the CY 2018 HH PPS proposed rule and
those made by the TEP participants. We note the PDGM case-mix weights
reflect existing patterns of resource use observed in our analyses of
CY 2016 home health claims data. Since we propose to recalibrate the
PDGM case-mix weights on an annual basis to ensure that the case-mix
weights reflect the most recent utilization data available at the time
of rulemaking, future recalibrations of the PDGM case-mix weights may
result in changes to the case-mix weights for early versus late 30-day
periods of care as a result of changes in utilization patterns.
Several commenters responding to the CY 2018 HH PPS proposed rule
suggested that we revise the model such that a readmission to home
health within the 60-day gap period results in an ``early'' instead of
a ``late'' 30-day period. However, we note that the PDGM also includes
a category determined specifically by source of admission, which would
account for any readmission to home health. Under the PDGM we already
account for whether the patient was admitted to home health care from
the community or following an institutional stay, including inpatient
stays that occur after the commencement of a home health care. For
example, if the original home health stay was categorized as community
and subsequently the patient experienced an inpatient stay, the
subsequent home health stay would reset to institutional upon discharge
from the inpatient setting. Similarly, we note that for the purposes of
the timing component of the PDGM, an intervening hospital stay would
not trigger re-categorization to an ``early'' period unless there were
a 60-day gap in home health care. Therefore, we do not believe that the
timing element of the PDGM would create a financial incentive to
inappropriately encourage the admission of home health patients to an
acute care setting in order to receive a subsequent home health
referral in the higher-paid ``early'' category. Our proposal was
intended to refine and to better fit costs incurred by agencies for
patients with differing characteristics and needs under the prospective
payment system. Therefore, we expect that the addition of both the
source of admission, as well as the timing categories do reflect
agencies' average costs for home health patients and used in defining
payment groups. We believe that crafting a multi-pronged case-mix
adjustment model, which includes adjustments based both on timing
within a home health sequence as well as the source of the beneficiary
admission, will serve to more accurately account for resources required
for Medicare beneficiaries and similarly provide a differentiated
payment amount for care.
Several commenters responding to the CY 2018 HH PPS proposed rule
expressed concern regarding the operational aspects of the timing
element of the alternative case-mix adjustment methodology. As we
described in the CY 2018 HH PPS proposed rule, and as we are proposing
in this rule, we would use Medicare claims data and not the OASIS
assessment in order to determine if a 30-day period is considered
``early'' or ``late'' (82 FR 35309). We have developed claims
processing procedures to reduce the amount of administrative burden
associated with the implementation of the PDGM. Providers would not
have to determine whether a 30-day period is early (the first 30-day
period) or later (all adjacent 30-day periods beyond the first 30-day
period) if they choose not to. Information from Medicare systems would
be used during claims processing to automatically assign the
appropriate timing category.
[[Page 32394]]
To identify the first 30-day period within a sequence, the Medicare
claims processing system would verify that the claim ``From date'' and
``Admission date'' match. If this condition were to be met, our systems
would send the ``early'' indicator to the HH Grouper for the 30-day
period of care. When the claim was received by CMS's Common Working
File (CWF), the system would look back 60 days to ensure there was not
a prior, related 30-day period. If not, the claim would continue to be
paid as ``early.'' If another related 30-day period were to be
identified, that is an earlier 30-day period in the sequence, the claim
would be flagged as ``late'' and returned to the shared systems for
subsequent regrouping and re-pricing. Those periods that are not the
first 30-day period in a sequence of adjacent periods, separated by no
more than a 60 day gap, would be categorized as ``late'' periods and
placed in corresponding PDGM categories.
Early 30-day periods are defined as the initial 30-day period in a
sequence of adjacent 30-day periods. Late 30-day periods are defined as
all subsequent adjacent periods beyond the first 30-day period. Periods
are considered to be adjacent if they are contiguous, meaning that they
are separated by no more than a 60-day period between 30-day periods of
care. In determining a gap, we only consider whether the beneficiary
was receiving home health care from traditional fee-for-service
Medicare.
For example, if the beneficiary has not received home health care
through traditional Medicare for at least 60 days, and then receives
home health care from agency A, that is an early 30-day period. If that
30-day period receives a PEP adjustment and agency B recertifies the
beneficiary for a second 30-day period, that second 30-day period is
now considered a late 30-day period. However, the beneficiary could
have received home health care from other traditional Medicare
providers within 60 days before coming to agency A. The designation of
early or late would depend upon how many adjacent periods of care were
received prior to coming to agency A. The CWF will examine claims upon
receipt in comparison to all previously processed 30-day period to
verify that the period is correctly designated as early or later.
The 60-day period to determine a gap that will begin a new sequence
of 30-day periods will be counted in most instances from the calculated
end date of the 30-day period. That is, in most cases CWF will count
from ``day 30'' of a 30-day period without regard to an earlier
discharge date. The exception to this is for 30-day periods that were
subject to PEP adjustment. In PEP cases, CWF will count 60 days from
the date of the last billable home health visit provided. Under the
current HH PPS, the partial episode payment (PEP) adjustment is a
proportion of the episode payment that is based on the span of days,
including the start-of-care date or first billable service date,
through and including the last billable service date under the original
plan of care, before the intervening event in a home health
beneficiary's care, which is defined as: A beneficiary elected
transfer, or a discharge and return to home health that would warrant,
for purposes of payment, a new OASIS assessment, physician
certification of eligibility, and a new plan of care. Because PEPs are
paid based upon the last billable service date and not necessarily
based on the last day of a 60-day episode, we would consider the end of
the PEP HH episode as the last billable home health visit provided and
begin the count of gap days from the date of the last billable home
health visit and not ``day 30'' of a 30-day period.
Regarding PEP adjustments, consider the following example: A 30-day
period is opened on January 1, 2020 which would normally span until
January 30, 2020. If this 30-day period were not subject to a PEP
adjustment, any 30-day period beginning within 60 days following
January 30, 2020 would be considered an adjacent 30-day period. In the
case of a PEP adjustment, the determination of an adjacent 30-day
period would no longer be based on day 60, but would instead be based
on the latest billable visit in the 30-day period. Assume in the
example, the patient is transferred to another HHA (triggering the PEP
adjustment) on January 15, 2020 but the last billable visit is provided
on January 13, 2020. In this case, any 30-day period beginning within
60 days following the January 13, 2020 visit would be considered an
adjacent 30-day period.
Intervening stays in inpatient facilities will not create any
special considerations in counting the 60-day gap. If an inpatient stay
occurred within a period, it would not be a part of the gap, as
counting would begin at ``day 60'' which in this case would be later
than the inpatient discharge date. If an inpatient stay occurred within
the time after the end of the HH period and before the beginning of the
next one, those days would be counted as part of the gap just as any
other days would.
If periods are received after a particular claim is paid that
change the sequence initially assigned to the paid period (for example,
by service dates falling earlier than those of the paid period, or by
falling within a gap between paid periods), Medicare systems will
initiate automatic adjustments to correct the payment of any necessary
periods.
Upon receipt of a HH period coded to represent the early 30-day
period in a sequence, Medicare systems will search the period history
records that are maintained for each beneficiary. If an existing 30-day
period is found on that history, the claim for the new period will be
recoded to represent its sequence correctly and paid according to the
changed code. In addition, when any new 30-day period is added to those
history records for each beneficiary, the coding representing period
sequence on previously paid periods will be checked to see if the
presence of the newly added period causes the need for changes to those
periods. If the need for changes is found, Medicare systems will
initiate automatic adjustments to those previously paid periods.
For example, a given 30-day period is initially determined to be
and paid as the early period in a sequence of periods. After some
amount of time, a claim is submitted by another HHA that occurs before
the previously designated first period in the sequence of adjacent
periods and is less than 60 days before the beginning of that
previously designated first period. In such a case, the 30-day period
corresponding to the newly submitted claim becomes the first 30-day
period of this sequence of adjacent 30-day periods and thus is
considered to be an early period. The 30-day period previously
designated as the first 30-day period in the sequence of periods now
becomes the second 30-day period in the sequence of adjacent periods,
thus changing its status from that of an early period to that of a late
period.
We plan to develop materials regarding timing categories, including
such topics as claims adjustments and resolution of claims processing
issues. We will also update guidance in the Medicare Claims Processing
Manual, as well as the Medicare Benefit Manual as appropriate with
detailed procedures. We will also work with our Medicare Administrative
Contractors (MACs) to address any concerns regarding the processing of
home health claims as well as develop training materials to facilitate
all aspects of the transition the PDGM, including the unique aspects of
the timing categories.
Several commenters responding to the CY 2018 HH PPS proposed rule
had concerns regarding the potential for problematic provider behavior
due to financial incentives. We note that we
[[Page 32395]]
fully intend to monitor provider behavior in response to the new PDGM.
As we receive and evaluate new data related to the provision of
Medicare home health care under the PDGM, we will reassess the
appropriateness of the payment levels for ``early'' and ``late''
periods in a sequence of periods. Additionally, we will share any
concerning behavior or patterns with the Medicare Administrative
Contracts (MACs) as well as our Center for Program Integrity. We plan
to monitor for and identify any variations in the patterns of care
provided to home health patients, including both increased and
decreased provision of care to Medicare beneficiaries. We note that an
increase in the volume of Medicare beneficiaries receiving home health
care may, in fact, represent a positive outcome of the PDGM, signaling
increased access to care for the Medicare population, so long as said
increase in volume of beneficiaries is appropriate and in keeping with
eligibility guidelines for the Medicare home health benefit.
We invite public comments on the timing categories in the proposed
PDGM and the associated regulations text changes outlined in section
III.F.13. of this proposed rule.
5. Admission Source Category
In the CY 2018 HH PPS proposed rule, we described analysis showing
the impact of the source of admission on home health resource use and
proposed to classify periods into one of two admission source
categories--community or institutional--depending on what healthcare
setting was utilized in the 14 days prior to home health (82 FR 35309).
We proposed that a 30-day period would be categorized as institutional
if an acute or post-acute care (PAC) stay occurred in the 14 days prior
to the start of the 30-day period of care. We also proposed that a 30-
day period would be categorized as community if there was no acute or
PAC stay in the 14 days prior to the start of the 30-day period of
care. We proposed to adopt this categorization by admission source with
the implementation of alternative case-mix adjustment methodology
refinements.
The proposed admission source category was discussed in detail in
the CY 2018 HH PPS proposed rule and we solicited public comments on
the admission source component of the proposed alternative case-mix
adjustment methodology. Several commenters expressed their support for
the admission categories within the framework of the alternative case-
mix adjustment methodology refinements, as they believe that these
groups would be meaningful and would more appropriately align the cost
of Medicare home health care with payments, thereby improving the
accuracy of the HH payment system under the alternative case-mix
adjustment methodology refinements. Commenters also expressed a variety
of concerns regarding admission source, stating that the source of a
home health admission may not always correspond with home health
beneficiary needs and associated provider costs, that the categories
would discourage the admission of community entrants due to lower
reimbursement, that the differentiation may encourage HHAs to favor
hospitalization during an episode of home health care, that agencies'
ability to provide the care for beneficiaries in the community would be
reduced, and that small HHAs with no hospital affiliation would be
negatively impacted. Several commenters recommended that CMS consider
incorporating other clinical settings into the definition of the
institutional category, including hospices and outpatient facilities.
Several commenters also expressed concern regarding the operational
aspects of the admission source category, requesting guidance for
retroactive adjustments, plans for the claims readjustment process due
to institutional claim issues, definitions for timely filing, and
guidance regarding when occurrence codes may be utilized. Moreover, in
accordance with the requirement of section 51001 of the BBA of 2018, a
Technical Expert Panel (TEP) convened in February 2018 to solicit
feedback and identify and prioritize recommendations from a wide
variety of industry experts and patient representatives regarding the
public comments received on the proposed alternative case-mix
adjustment methodology. Comments on the admission source categories and
suggestions for refinement to this element of the alternative case-mix
system were very similar between those received in response to the CY
2018 HH PPS proposed rule and those provided by the TEP participants.
We appreciate commenters' feedback regarding the admission source
element of the alternative case-mix adjustment methodology. The
intention of the proposal included in the CY 2018 HH PPS proposed rule,
including the admission source component, was to refine and to better
fit costs incurred by agencies for patients with differing
characteristics and needs under the HH prospective payment system, and
we believe that the differing weights for source of admission will
serve to promote appropriate alignment between costs and payment within
the HH PPS.
As described in the CY 2018 HH PPS proposed rule, our analytic
findings demonstrate that institutional admissions have higher average
resource use when compared with community admissions, which ultimately
led to the inclusion of the admission source category within the
framework of the alternative case-mix adjustment methodology
refinements (82 FR 35309). The differences in care needs during home
health based on admission source are illustrated in the resource
utilization figures presented in Table 35, which shows the distribution
of admission sources as well as average resource use for 30-day periods
by admission source.
Table 35--Average Resource Use by Admission Source (14 Day Look-Back; 30 Day Periods) Admission Source, Community and Institutional Only
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Average Frequency Percent of deviation percentile Median percentile
resource of periods periods of resource of resource resource of resource
use use use use use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community.................................................... $1,363.11 6,408,805 74.3 $1,119.20 $570.26 $1,062.05 $1,817.75
Institutional................................................ 2,171.00 2,215,971 25.7 1,303.24 1,246.05 1,920.06 2,791.91
------------------------------------------------------------------------------------------
Total.................................................... 1,570.68 8,624,776 100.0 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
Institutional admissions have significantly higher average resource
use at $2,171.00 compared with community admissions at $1,363.11, a
difference of $807.89. Median values of resource use also show a
significant difference
[[Page 32396]]
between sources of admission, with institutional resource use at
$1,920.06 while community resource use is at $1,062.05, a difference of
$858.01. The pattern of higher resource use for institutional
admissions as compared to community admissions remains consistent for
the 25th and 75th percentiles, with a difference of approximately $675
and $974, respectively.
Additionally, we note that we do not show preference to any
particular patient profile, but rather aim to better align home health
payment with the costs associated with providing care. As discussed in
our CY 2018 HH PPS proposed rule, current research around those
patients who are discharged from acute and PAC settings shows that
these beneficiaries tend to be sicker upon admission, are being
discharged rapidly back to the community, and are more likely to be re-
hospitalized after discharge due to the acute nature of their
illness.\35\ Additionally, as further described in the CY 2018 HH PPS
proposed rule, research studies indicate that patients admitted to home
health from institutional settings are vulnerable to adverse effects
and injury because of the functional decline that occurs due to their
institutional stay, indicating that the patient population referred
from an institutional setting requires more concentrated resources and
supports to account for and mitigate this functional decline.\36\
Moreover, as described in the CY 2018 HH PPS proposed rule, research
suggests that the reduction in monitoring from the level typically
experienced in an inpatient facility to that in the home environment
can potentially cause gaps in care and consequently increased risk for
adverse events for the newly-admitted home health beneficiary, and any
negative impacts of the transition to the home setting can be reduced
by an appropriate increase in care for the beneficiary, particularly
through more frequent assessment of their condition and ongoing
monitoring once transferred to the home environment.\37\ Furthermore,
research discussed in our CY 2018 HH PPS proposed rule shows that
beneficiaries discharged from institutional settings are more
vulnerable because of, among other factors, the need to manage new
health care issues, major modifications to medication interventions,
and the coordination of follow-up appointments, which could lead to the
risk for adverse drug events, for errors in a beneficiary's medication
regimen, and for the need to readmit to the hospital due to
deterioration of the patient's condition.\38\ Additionally, we note
that the goal of the admission source variable is not to identify or
evaluate for increases in re-hospitalization in the home health
beneficiary population but rather to align payment with the costs of
providing home health care. Other CMS initiatives such as the HH QRP as
well as the HH VBP demonstration take into account readmissions, among
other measures of quality. However, because this population is at
higher risk for possible readmission to an institutional setting, we
believe that more intensive supports, partnered with differentiated
payment weights, are appropriate in crafting a payment system that
better reflects the costs incurred by HHAs while also promoting the
delivery of quality care to the Medicare population. In summary,
clinical research continues to indicate that the needs of the
institutional population are intensive. Likewise, our analysis of home
health data shows that costs sustained by home health agencies for
those beneficiaries admitted from institutional settings are higher
than community entrants. Therefore, we believe that accounting for
these material differences in the care needs of the beneficiary
population admitted from institutional settings and their resultant,
differentiated resource use, will serve to better align payments with
actual costs incurred by HHAs when caring for Medicare beneficiaries.
---------------------------------------------------------------------------
\35\ O'Connor, M. (2012, February). Hospitalization Among
Medicare-Reimbursed Skilled Home Health Recipients. Retrieved March
02, 2017, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690459.
\36\ Rosati, R. J., Huang, L., Navaie-Waliser, M., & Feldman, P.
H. (2003). Risk Factors for Repeated Hospitalizations Among Home
Healthcare Recipients. Journal For Healthcare Quality, 25(2), 4-11.
doi:10.1111/j.1945-1474.2003.tb01038.x.
\37\ Forster, A. J. (2003). The Incidence and Severity of
Adverse Events Affecting Patients after Discharge from the Hospital.
Annals of Internal Medicine, 138(3), 161. doi:10.7326/0003-4819-138-
3-200302040-00007.
\38\ Meyers, A. G., Salanitro, A., Wallston, K. A., Cawthon, C.,
Vasilevskis, E. E., Goggins, K. M., . . . Kripalani, S. (2014).
Determinants of health after hospital discharge: Rationale and
design of the Vanderbilt Inpatient Cohort Study (VICS). BMC Health
Services Research, 14(1). doi:10.1186/1472-6963-14-10.
---------------------------------------------------------------------------
We expect that HHAs will continue to provide the most appropriate
care to Medicare home health beneficiaries, regardless of admission
source or any other category related to home health payment. As we
noted in the CY 2018 HH PPS proposed rule, the primary goal of home
health care is to provide restorative care when improvement is
expected, maintain function and health status if improvement is not
expected, slow the rate of functional decline to avoid
institutionalization in an acute or post-acute care setting, and/or
facilitate transition to end-of-life care as appropriate (82 FR 35348).
The primary goal of the HH PPS is to align payment with the costs of
providing home health care. Furthermore, in our CY 2000 HH PPS final
rule, commenters asserted that patients admitted to home health from
the hospital were often more acutely ill and resource-intensive than
other patients, particularly when compared with beneficiaries who had
no institutional care prior to admission (64 FR 41147). We appreciate
the concerns expressed in response to the CY 2018 HH PPS proposed rule
regarding possible behavioral changes by providers given the perceived
incentives created by the admission source categories within the
alternative case-mix adjustment methodology. However, we continue to
expect that HHAs will provide the appropriate care needed by all
beneficiaries who are eligible for the home health benefit, including
those beneficiaries with medically-complex conditions who are admitted
from the community. We will carefully monitor the outcomes of the
proposed change, including any impacts to community entrants, and make
further refinements as necessary.
Regarding the incorporation of other clinical settings into the
definition of the institutional category under the alternative case-mix
adjustment methodology that some commenters raised in response to the
CY 2018 HH PPS proposed rule, such as emergency department (ED) use and
observational stays, we propose to only include those stays that are
considered institutional stays in other Medicare settings. For example,
observational stays do not count towards the 3-day window for an
admission to a SNF because they are not categorized as inpatient.
Additionally, in our analysis of 2017 HH claims data, we identified
those HH stays that, within the 14 days prior to admission to HH, had
been preceded by ED visits or outpatient observational stays and
isolated these stays from stays that would otherwise be grouped into
the community admission source category. As demonstrated in Table 36,
30-day periods of care for beneficiaries with a preceding ED visit
(which would otherwise be grouped into the community admission source
category) do not show higher resource use when compared to those
beneficiaries entering from acute or PAC settings, with an average
resource use at $1,660.64 per home health period as compared to
$2,171.00 for institutional admits. When compared with those patients
admitted from the community, admissions from
[[Page 32397]]
the ED show somewhat higher resource use at $1,660.64 per home health
period as compared to $1,337.73 for community admits. We note that the
volume of patients with preceding ED visits is relatively low, at about
5.8 percent of total home health periods.
Table 36--Average Resource Use by Admission Source (14 Day Look-Back, 30 Day Periods) Admission Source: Community, Institutional, and Emergency
Department
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Average Number of Percent of deviation percentile Median percentile
resource 30-day 30-day of resource of resource resource of resource
use periods periods use use use use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community.................................................... $1,337.73 5,905,217 68.5 $1,108.57 $558.54 $1,035.34 $1,779.73
Institutional................................................ 2,171.00 2,215,971 25.7 1,303.24 1,246.05 1,920.06 2,791.91
Emergency Department......................................... 1,660.64 503,588 5.8 1,197.60 782.63 1,396.50 2,225.38
------------------------------------------------------------------------------------------
Total.................................................... 1,570.68 8,624,776 100.0 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Similarly, 30-day periods for beneficiaries with preceding
observational stays (which would otherwise be grouped into the
community admission source category) also do not show higher resource
use when compared to those beneficiaries entering from acute or PAC
settings, as described in Table 37, with average resource use at
$1,820.06 per home health period as compared to $2,171.00 for
institutional admits.
Table 37--Average Resource Use by Admission Source (14 Day Look-Back; 30 Day Periods) Admission Source: Community, Institutional, and Observational
Stays
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Average Number of Percent of deviation percentile Median percentile
resource 30-day 30-day of resource of resource resource of resource
use periods periods use use use use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community.................................................... $1,350.90 6,242,043 72.4% $1,114.94 $564.31 $1,048.86 $1,799.27
Institutional................................................ 2,171.00 2,215,971 25.7% 1,303.24 1,246.05 1,920.06 2,791.91
Observational Stays.......................................... 1,820.06 166,762 1.9% 1,180.96 960.15 1,589.08 2,399.68
------------------------------------------------------------------------------------------
Total.................................................... 1,570.68 8,624,776 100.0% 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
When compared with those patients admitted from the community,
admissions from observational stays show higher resource use at
$1,820.06 per home health period as compared to $1,350.90 for community
admits. However, the volume of patients with preceding observational
stays is very low, at about 2 percent of total home health periods.
In summary, home health stays with preceding observational stays
and ED visits show resource use that falls between that of the
institutional and community categories. However, the resource use is
not equivalent to that of the institutional settings; therefore, we do
not believe it appropriate to include observational stays and ED visits
in the institutional category for the purposes of the PDGM.
Additionally, including these stays in the institutional category would
lead to a small reduction in the overall average resource use and
related case mix weights for groups admitted from acute and PAC
settings. Moreover, including ED or observational stays with discharges
from acute care hospitals, LTCHs, IRFs and SNFs would be inconsistent
with section 1861(tt)(1) of the Act, which defines the term ``post-
institutional home health services'' as discharges from hospitals
(which include IRFs and LTCHs) and SNFs within 14 days of when home
health care is initiated.
We explored the option of creating a third admission source
category specifically for observational stays/ED visits. In order to
more fully understand the potential impact of a third category, we
analyzed the overall impact of the creation of such a category. For the
purposes of this analysis, in the event that a home health stay was
preceded by both an institutional stay and an observation stay or ED
visit, the case would be grouped into the institutional category. Our
findings indicate for those HH stays with a preceding outpatient
observational stay/ED visit, the overall payment weight for associated
groups for ``early'' 30-day periods (as defined in section III.F.4 of
this rule) would be approximately 6 percent higher than the community
admission counterparts, whereas institutional stays would see weights
that are approximately 19 percent higher than community admissions.
When examining the overall payment weights for ``late'' 30-day periods
(as defined in section III.F.4 of this rule), HH stays with a preceding
outpatient admission would observe weights that are approximately 10
percent higher than the community admission counterparts, whereas
institutional stays would see weights that are approximately 43 percent
higher than community admissions. However, we are concerned that a
third admission source category for observational stays and ED visits
could create an incentive for providers to encourage outpatient
encounters both prior to a 30-day period of care or within a 30-day
period of care within 14 days of the start of the next 30-day period,
thereby potentially inappropriately increasing costs to the Medicare
program overall. The clinical threshold for an observational stay or an
ED visit is not as high as that required for an institutional
admission, and we are concerned that home health agencies may encourage
beneficiaries to engage with emergency departments before initiating a
home health stay.
For example, in the FY 2014 IPPS/LTCH PPS final rule and also the
Medicare Benefit Policy Manual Chapter 1--Inpatient Hospital Services
Covered Under Part A, CMS clarified and specified in the regulations
that an individual becomes an inpatient of a hospital, including a long
term care hospital or a Critical Access Hospital, when formally
admitted as such pursuant to an order for inpatient admission by a
physician or other qualified practitioner described in the final
regulations (78 FR 50495). The
[[Page 32398]]
order is required for payment of hospital inpatient services under
Medicare Part A. CMS also specified that for those hospital stays in
which the physician expects the beneficiary to require care that
crosses two midnights and admits the beneficiary based upon that
expectation, Medicare Part A payment is generally appropriate.
Additionally, for the purposes of admissions to skilled nursing
facilities, the Medicare Benefit Policy Manual Chapter 8--Coverage of
Extended Care (SNF) Services Under Hospital Insurance states that in
order to qualify for post-hospital extended care services, the
individual must have been an inpatient of a hospital for a medically
necessary stay of at least three consecutive calendar days and that
time spent in observation or in the emergency room prior to (or in lieu
of) an inpatient admission to the hospital does not count toward the 3-
day qualifying inpatient hospital stay, as a person who appears at a
hospital's emergency room seeking examination or treatment or is placed
on observation has not been admitted to the hospital as an inpatient;
instead, the person receives outpatient services. Furthermore,
admission to an inpatient rehabilitation facility (IRF) requires that
for IRF care to be considered reasonable and necessary, the
documentation in the patient's IRF medical record must demonstrate a
reasonable expectation that the patient must require active and ongoing
intervention of multiple therapy disciplines, at least one of which
must be PT or OT; require an intensive rehabilitation therapy program,
generally consisting of 3 hours of therapy per day at least 5 days per
week; or in certain well-documented cases, at least 15 hours of
intensive rehabilitation therapy within a 7-consecutive day period,
beginning with the date of admission; reasonably be expected to
actively participate in, and benefit significantly from the intensive
rehabilitation therapy program; require physician supervision by a
rehabilitation physician, with face-to-face visits at least 3 days per
week to assess the patient both medically and functionally and to
modify the course of treatment as needed; and require an intensive and
coordinated interdisciplinary team approach to the delivery of
rehabilitative care, as described in detail in Medicare Benefit Policy
Manual, Chapter 1--Inpatient Hospital Services Covered Under Part A
110.2--Inpatient Rehabilitation Facility Medical Necessity Criteria.
Conversely, CMS specified that for hospital stays in which the
physician expects the patient to require care less than two midnights,
payment under Medicare Part A is generally inappropriate. (However, we
note that in the CY 2016 Outpatient Prospective Payment System final
rule, CMS adopted a policy such that for stays for which the physician
expects the patient to need less than two midnights of hospital care
(and the procedure is not on the inpatient-only list or otherwise
listed as a national exception), an inpatient admission may be payable
under Medicare Part A on a case-by-case basis based on the judgment of
the admitting physician (80 FR 70297).)
Regarding emergency department visits by Medicare beneficiaries,
services are generally covered by Medicare Part B in instances where a
beneficiary experiences an injury, a sudden illness, or an illness that
quickly worsens. In the case of observational stays, as described in
the Medicare Claims Processing Manual, Chapter 12, observation care is
a well-defined set of specific, clinically appropriate services, which
include ongoing short term treatment, assessment, and reassessment
before a decision can be made regarding whether patients will require
further treatment as hospital inpatients or if they are able to be
discharged from the hospital. As described in the Medicare Benefit
Policy Manual, Chapter 6--Hospital Services Covered Under Part B 20.6--
Outpatient Observation Services, observation services are commonly
ordered for patients who present to the emergency department and who
then require a significant period of treatment or monitoring in order
to make a decision concerning their admission or discharge. Moreover,
the Medicare Claims Processing Manual in Chapter 4--Part B Hospital,
290--Outpatient Observation Services states that observation services
are covered by Medicare only when provided by the order of a physician
or another individual authorized by state licensure law and hospital
staff bylaws to admit patients to the hospital or to order outpatient
tests. In the majority of cases, the decision whether to discharge a
patient from the hospital following resolution of the reason for the
observation care or to admit the patient as an inpatient can be made in
less than 48 hours, usually in less than 24 hours. In only rare and
exceptional cases do reasonable and necessary outpatient observation
services span more than 48 hours. In summary, the clinical thresholds
for coverage and payment for an admission to institutional settings are
higher when compared with ED visits and observational stays. Finally,
we note that the proportion of home health periods with admissions from
ED visits and observational stays is low relative to community and
institutional counterparts. Creating a third community admission source
category for observational stays and ED visits would potentially
introduce added complexity into the payment system for a small portion
of home health stays, which could lead to the creation of payment
groups that contain very few stays with very little difference in case-
mix weights across the landscape of groups.
For all of these reasons, we believe that incorporating HH stays
with preceding observational stays and ED visits into the community
admission category is most appropriate at this time. However, we note
that as we receive and evaluate new data related to the provision of
Medicare home health care under the PDGM, we will continue to assess
the appropriateness of the payment levels for admission source within a
home health period and give consideration to any cost differentiation
evidenced by the resources required by those home health patients with
a preceding outpatient event.
Regarding the operational aspects of the admission source category,
as described in the CY 2018 HH PPS proposed rule, we have developed
automated claims processing procedures with the goal of reducing the
amount of administrative burden associated with the admission source
category of the alternative case-mix adjustment methodology (82 FR
35309). For example, Medicare systems will automatically determine
whether a beneficiary has been discharged from an institutional setting
for which Medicare paid the claim, using information used during claims
processing to systematically identify admission source and address this
issue. When the Medicare claims processing system receives a Medicare
home health claim, the systems will check for the presence of a
Medicare acute or PAC claim for an institutional stay. If such an
institutional claim is found, and the institutional stay occurred
within 14 days of the home health admission, our systems will trigger
an automatic adjustment of the corresponding HH claim to the
appropriate institutional category. Similarly, when the Medicare claims
processing system receives a Medicare acute or PAC claim for an
institutional stay, the systems will check for the presence of a
subsequent HH claim with a community payment group. If such a HH claim
is found, and the institutional stay occurred within 14 days of the
home health admission, our systems will trigger an automatic
[[Page 32399]]
adjustment of the HH claim to the appropriate institutional category.
This process may occur any time within the 12-month timely filing
period for the acute or PAC claim. The OASIS assessment will not be
utilized in evaluating for admission source information.
Moreover, as we also proposed in the CY 2018 HH PPS proposed rule,
we propose in this rule that newly-created occurrence codes would also
be established, allowing HHAs to manually indicate on Medicare home
health claims that an institutional admission had occurred prior to the
processing of an acute or PAC Medicare claim, if any, in order to
receive the higher payment associated with the institutional admission
source sooner (82 FR 35312). However, the usage of the occurrence codes
is limited to situations in which the HHA has information about the
acute or PAC stay. We also noted that the use of these occurrence codes
would not be limited to home health beneficiaries for whom the acute or
PAC claims were paid by Medicare. HHAs would also use the occurrence
codes for beneficiaries with acute or PAC stays paid by other payers,
such as the Veterans Administration (VA).
If a HHA does not include on the HH claim the occurrence code
indicating that a home health patient had a previous institutional
stay, processed either by Medicare or other institutions such as the
VA, such an admission will be categorized as ``community'' and paid
accordingly. However, if later a Medicare acute or PAC claim for an
institutional stay occurring within 14 days of the home health
admission is submitted within the timely filing deadline and processed
by the Medicare systems, the HH claim would be automatically adjusted
and re-categorized as an institutional admission and appropriate
payment modifications would be made. If there was a non-Medicare
institutional stay occurring within 14 days of the home health
admission but the HHA was not aware of such a stay, upon learning of
such a stay, the HHA would be able to resubmit the HH claim that
included an occurrence code, subject to the timely filing deadline, and
payment adjustments would be made accordingly.
We note that the Medicare claims processing system will check for
the presence of an acute or PAC Medicare claim for an institutional
stay occurring within 14 days of the home health admission on an
ongoing basis and automatically assign the home health claim as
``community'' or ``institutional'' appropriately. As a result, with
respect to a HH claim with a Medicare institutional stay occurring
within 14 days of home health admission, we will not require the
submission of an occurrence code in order to appropriately categorize
the HH claim to the applicable admission source. With respect to a HH
claim with a non-Medicare institutional stay occurring with 14 days of
home health admission, a HHA would need to submit an occurrence code on
the HH claim in order to have the HH claim categorized as
``institutional'' and paid the associated higher amount. Additionally,
we plan to provide education and training regarding all aspects of the
admission source process and to develop materials for guidance on
claims adjustments, for resolution of claims processing issues, for
defining timely filing windows, and for appropriate usage of occurrence
codes through such resources as the Medicare Learning Network. We will
also update guidance in the Medicare Claims Processing Manual as well
as the Medicare Benefit Policy Manual as appropriate with detailed
procedures. We will also work with our Medicare Administrative
Contractors (MACs) to address any concerns regarding the processing of
home health claims as well as develop training materials to facilitate
all aspects of the transition to the PDGM, including the unique aspects
of the admission source categories.
With regards to the length of time for resubmission of home health
claims that reflect a non-Medicare institutional claim, all appropriate
Medicare rules regarding timely filing of claims will still apply.
Procedures required for the resubmission of home health claims will
apply uniformly for those claims that require editing due to the need
to add or remove occurrence codes. Details regarding the timely filing
guidelines for the Medicare program are available in the Medicare
Claims Processing Manual, Chapter 1--General Billing Requirements,
which is available at the following website: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c01.pdf.
Additionally, adjustments to any re-submitted home health claims will
be processed in the same manner as other edited Medicare home health
claims. Additionally, we plan to perform robust testing within the
Medicare claims processing system to optimize and streamline the
payment process.
Regarding the process by which HHAs should verify a non-Medicare
institutional stay, as we noted in in the CY 2018 HH PPS proposed rule,
we expect home health agencies would utilize discharge summaries from
all varieties of institutional providers (that is, Medicare and non-
Medicare) to inform the usage of these occurrence codes, and these
discharge documents should already be part of the beneficiary's home
health medical record used to support the certification of patient
eligibility as outlined in Sec. 424.22(c) (82 FR 35309). Providers
should utilize existing strategies and techniques for verification of
such stays and incorporate relevant clinical information into the plan
of care, as is already required by our Conditions of Participation.
Our evaluation process within the Medicare claims processing system
will check for the presence of an acute or PAC Medicare claim for an
institutional stay occurring within 14 days of the home health
admission on an ongoing basis. Under this approach, the Medicare
systems would only evaluate for whether an acute or PAC Medicare claim
for an institutional stay occurring within 14 days of the home health
admission was processed by Medicare, not whether it was paid.
Therefore, we do not expect that a home health claim will be denied due
to unpaid Medicare claims for preceding acute or PAC admissions.
Moreover, as previously stated above, we note that providers would have
the option to submit the occurrence code indicating a preceding
institutional stay in order to categorize the home health admission as
``institutional.'' In the case of a HHA submitting an occurrence code
because of a preceding Medicare institutional stay, if upon medical
review after finding no Medicare acute or PAC claims in the National
Claims History, and there is documentation of a Medicare acute or PAC
stay within the 14 days prior to the home health admission, but the
institutional setting did not submit its claim in a timely fashion, or
at all, we would permit the institutional categorization for the
payment of the home health claim through appropriate administrative
action. Similarly, in the case of a HHA submitting an occurrence code
because of a preceding non-Medicare institutional stay, if
documentation of a non-Medicare acute or PAC stay within the 14 days
prior to the home health admission, is found, we would permit the
categorization of the home health claim as ``institutional''.
However, if upon medical review after finding no acute or PAC
Medicare claims in the National Claims History, and there is no
documentation of an acute or PAC stay, either a Medicare or non-
Medicare stay, within 14 days of the home health admission, we would
[[Page 32400]]
correct the overpayment. If upon medical review after finding no
Medicare acute or PAC claims in the National Claims History and we find
that an HHA is systematically including occurrence codes that indicate
the patient's admission source was ``institutional,'' but no
documentation exists in the medical record of Medicare or non-Medicare
stays, we would refer the HHA to the zone program integrity contractor
(ZPIC) for further review. Moreover, we intend to consider targeted
approaches for medical review after the implementation of the admission
source element of the PDGM, including potentially identifying HHAs that
have claims that are consistently associated with acute or PAC denials,
whose utilization pattern of acute or PAC occurrence codes is aberrant
when compared with their peers, or other such metrics that would
facilitate any targeted reviews.
For all of the reasons described above, we are proposing to
establish two admission source categories for grouping 30-day periods
of care under the PDGM--institutional and community--as determined by
the healthcare setting utilized in the 14 days prior to home health
admission. We are proposing that 30-day periods for beneficiaries with
any inpatient acute care hospitalizations, skilled nursing facility
(SNF) stays, inpatient rehabilitation facility (IRF) stays, or long
term care hospital (LTCH) stays within the 14 days prior to a home
health admission would be designated as institutional admissions. We
are proposing that the institutional admission source category would
also include patients that had an acute care hospital stay during a
previous 30-day period of care and within 14 days prior to the
subsequent, contiguous 30-day period of care and for which the patient
was not discharged from home health and readmitted (that is, the
admission date and from date for the subsequent 30-day period of care
do not match) as we acknowledge that HHAs have discretion as to whether
they discharge the patient due to a hospitalization and then readmit
the patient after hospital discharge. However, we are proposing that we
would not categorize PAC stays (SNF, IRF, LTCH stays) that occur during
a previous 30-day period and within 14 days of a subsequent, contiguous
30-day period of care (that is, the admission date and from date for
the subsequent 30-day period of care do not match) as institutional, as
we would expect the HHA to discharge the patient if the patient
required PAC in a different setting and then readmitted the patient, if
necessary, after discharge from such setting. If the patient was
discharged and then readmitted to home health, the admission date and
``from'' date on the 30-day claim would match and the claims processing
system will look for an acute or a PAC stay within 14 days of the home
health admission date. This admission source designation process would
be applicable to institutional stays paid by Medicare or any other
payer. All other 30-day periods would be designated as community
admissions.
For the purposes of a RAP, we would only adjust the final home
health claim submitted for source of admission. For example, if a RAP
for a community admission was submitted and paid, and then an acute or
PAC Medicare claim was submitted for that patient before the final home
health claim was submitted, we would not adjust the RAP and would only
adjust the final home health claim so that it reflected an
institutional admission. Additionally, HHAs would only indicate
admission source occurrence codes on the final claim and not on any
RAPs submitted.
We invite public comments on the admission source component of the
proposed PDGM payment system.
6. Clinical Groupings
In the CY 2018 HH PPS proposed rule (82 FR 35307), we discussed the
findings of the Home Health Study Report to Congress, which indicates
that the current payment system may encourage HHAs to select certain
types of patients over others.\39\ Patients with a higher severity of
illness, including those receiving a greater level of skilled nursing
care; for example, patients with wounds, with ostomies, or who are
receiving total parenteral nutrition or mechanical ventilation were
associated with higher resource use and lower margins. This may have
produced a disincentive for providing care for patients with higher
clinical acuity, and thereby may have limited access of home health
services to these vulnerable patient populations.\40\ We noted that
payment should be predicated on resource use and proposed that
adjusting payment based on identified clinical characteristics and
associated services would better align payment with resource use.
---------------------------------------------------------------------------
\39\ Report to Congress. Medicare Home Health Study: An
Investigation on Access to Care and Payment for Vulnerable Patient
Populations. Available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/HH-Report-to-Congress.pdf.
\40\ Report to the Congress: Medicare Payment Policy. (2015)Home
health care services: Assessing payment adequacy and updating
payments. Ch.9 http://www.medpac.gov/docs/default-source/reports/chapter-9-home-health-care-services-march-2015-report-.pdf?sfvrsn=0.
---------------------------------------------------------------------------
For these reasons, we propose grouping 30-day periods of care into
six clinical groups: Musculoskeletal Rehabilitation, Neuro/Stroke
Rehabilitation, Wounds--Post-Op Wound Aftercare and Skin/Non-Surgical
Wound Care, Behavioral Health Care (including Substance Use Disorder),
Complex Nursing Interventions, Medication Management, Teaching and
Assessment (MMTA). These clinical groups are designed to capture the
most common types of care that HHAs provide. We propose placement of
each 30-day period of care into a specific clinical group based on the
primary reason the patient is receiving home health care as determined
by the principal diagnosis reported on the claim. Although the
principal diagnosis code is the basis for the clinical grouping,
secondary diagnosis codes and patient characteristics would then be
used to case-mix adjust the period further through the comorbidity
adjustment and functional level. A complete list of ICD-10-CM codes and
their assigned clinical groupings is posted on the CMS HHA Center web
page (https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html). More information on the analysis and development of the
groupings can be found in the CY 2018 HH PPS proposed rule as well as
the HHGM technical report from December 2016, also available on the HHA
Center webpage.
In the CY 2018 HH PPS proposed rule, we solicited comments on the
clinical groups and the assigned clinical groupings of the ICD-10-CM
codes. Additionally, in February 2018, a Technical Expert Panel (TEP)
was held in order to gain insight from industry leaders, clinicians,
patient representatives, and researchers with experience in home health
care and/or experience in home health agency management. Many
commenters and TEP members supported the patient-centered approach to
grouping patients by clinical characteristics, and several commenters
felt that the clinical groupings did capture the majority of
characteristics of the home health population. Specifically, commenters
generally approved of the higher-weighted complex nursing and wound
groups, and agreed with the ``importance the HHGM places on these
complex patients through its proposed payment rate.'' One commenter
stated that ``the most complex and costly beneficiaries for a HHA are
those that require intensive nursing care, while
[[Page 32401]]
those that require intensive therapy produce a significant margin with
less cost.'' Additional comments on the clinical groups generally
included the following: Concern that some diagnosis codes are not used
to group claims into the six clinical groups; concern about reduced
therapy use in the clinical groups that aren't specifically for
musculoskeletal or neurological rehabilitation; concern that the groups
do not capture clinically complex patients that require multiple home
health disciplines; suggestions that the clinical groups should be
based on impairments rather than diagnoses; and concern that the MMTA
clinical group encompasses too many diagnosis codes. Several commenters
expressed concern that certain ICD 10-CM diagnosis codes were not used
for payment (for example, codes that were not used to group claims into
the six clinical groupings), which could possibly restrict access to
the benefit or force beneficiaries to seek care in institutional
settings. Others had concerns regarding specific diagnosis codes they
felt should be reassigned to different clinical groups.
As outlined in the HHGM technical report from December 2016 and in
the CY 2018 HH PPS proposed rule (82 FR 35314), there were several
reasons why a diagnosis code was not assigned to one of the six
clinical groups. These included if the diagnosis code was too vague,
meaning the code does not provide adequate information to support the
need for skilled home health services (for example H57.9, Unspecified
disorder of eye and adnexa); the code, based on ICD 10-CM, American
Hospital Association (AHA) Coding Clinic, or Medicare Code Edits (MCE)
would indicate a non-home health service (for example, dental codes);
the code is a manifestation code subject to a manifestation/etiology
convention, meaning that the etiology code must be reported as the
principal diagnosis, or the code is subject to a code first sequencing
convention (for example, G99.2 myelopathy in diseases classified
elsewhere); the code identifies a condition which would be unlikely to
require home health services (for example, L81.2, Freckles); the code
is restricted to the acute care setting per ICD 10-CM/AHA Coding
Clinic, or the diagnosis indicates death as the outcome (for example
S06.1X7A, Traumatic cerebral edema with loss of consciousness of any
duration with death due to brain injury prior to regaining
consciousness). We did, however, review and re-group certain codes
based on commenter feedback. For example, with regard to the
classification of N39.0, Urinary tract infection, site not specified as
an invalid code to group the home health period of care, we do agree
that absent definitive information provided by the referring physician,
a home health clinician would not know the exact site of a urinary
tract infection (UTI). As such, Urinary tract infection, site not
specified (N39.0) will be grouped under MMTA, as the home health
services required would most likely involve teaching about the
treatment for the UTI, as well as evaluating the effectiveness of the
medication regimen. We encourage HHAs to review the list of diagnosis
codes in the PDGM Grouping Tool posted on the HHA Center web page at:
https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html. Additionally, the ICD-10-CM code set exceeds the ICD-9-CM
in the number of diagnoses and conditions and contains codes that are
much more granular. Therefore, we disagree that excluding certain codes
from payment will restrict access, considering the increase in
diagnoses potentially requiring home health.
With regard to commenter concern that the HHGM clinical groups did
not account for the need for therapy in home health periods that are
not specifically grouped into musculoskeletal or neurological
rehabilitation, we continue to expect the ordering physician, in
conjunction with the therapist to develop and follow a plan of care for
any home health patient, regardless of clinical group, as outlined in
the skilled service requirements at Sec. 409.44, when therapy is
deemed reasonable and necessary. Although the principal diagnosis is a
contributing factor in the PDGM and determines the clinical group, it
is not the only consideration in determining what home health services
are needed in a patient's plan of care. It is the responsibility of the
patient's treating physician to determine if and what type of therapy
the patient needs regardless of clinical grouping. In accordance with
Sec. 409.44(c)(1)(i), the therapy goals must be established by a
qualified therapist in conjunction with the physician when determining
the plan of care. As such, therapy may likely be included in the plan
of care for a patient in any of the six clinical groupings. Any therapy
indicated in the plan of care is expected to meet the requirements
outlined in Sec. 409.44, which states that all therapy services must
relate directly and specifically to a treatment regimen (established by
the physician, after any needed consultation with the qualified
therapist). Additional requirements dictate that the amount, frequency,
and duration of the services must be reasonable and necessary, as
determined by a qualified therapist and/or physician, using accepted
standards of clinical practice. One goal in developing the PDGM is to
provide an appropriate payment based on the identified resource use of
different patient groups, not to encourage, discourage, value, or
devalue one type of skilled care over another.
Likewise, for patients requiring two or three home health
disciplines, the PDGM takes into account the functional level and
comorbidities of the patient after the primary reason for the period is
captured by the clinical grouping. Decreasing functional status, as
indicated by a specific set of OASIS items, and the presence of certain
comorbid conditions, is associated with increased resource use. Here is
where, when combined with the clinical grouping, any multi-disciplinary
therapy patients would be captured. For instance, a patient grouped
into the Neuro-Rehabilitation clinical grouping with a high Functional
Level (meaning high functional impairment) indicates increased therapy
needs, potentially utilizing all skilled therapy disciplines.
Additionally, the comorbidity adjustment further case mixes the period
and increases payment to capture the additional resource use for a
patient regardless of whether the services are skilled nursing or
therapy based. Therefore, a patient with complex needs, including
multiple therapy disciplines and medical management, is captured by the
combination of the different levels of the PDGM. Furthermore, the
current case-mix adjustment methodology does not differentiate between
utilization of therapy disciplines and whether or not all three are
utilized for the same patient. We have determined that the PDGM's
functional level when combined with the clinical grouping and
comorbidity adjustment actually provides a much clearer picture of the
patient's needs, particularly in relation to therapy services.
Comments on the CY 2018 HH PPS proposed rule and at the 2018 TEP
indicated that diagnosis does not always correlate with need and that
impairments and functional limitations are better predictors of therapy
services. Additionally, some commenters stated that clinicians are more
likely to focus on impairments and functional limitations when
conceptualizing overall patient care, and suggested using them as the
basis for the clinical groups rather than diagnosis codes. We do agree
that diagnosis alone does not
[[Page 32402]]
provide the entire clinical picture of the home health patient;
however, in the same way the clinical group is one aspect of the PDGM,
therapy services are only one aspect of home health. In fact, the
multidisciplinary nature of the benefit is precisely the reason that
diagnosis should be an important aspect of the clinical groupings
model. The various home health disciplines have different but
overlapping roles in treating the patient; however, a diagnosis is used
across disciplines and has important implications for patient care. A
patient's diagnosis consists of a known set of signs and symptoms
agreed upon by the medical community. Each different healthcare
discipline uses these identifiable signs and symptoms to apply its own
approach and skill set to treat the patient. However, it remains a
patient centered approach.
Several commenters and TEP participants alike, stated that the MMTA
clinical group is too broad and should be divided into more clinical
groups or subgroups. One commenter questioned whether it made sense to
assign patients to different clinical groupings if roughly 60 percent
of 30-day periods will fall into the MMTA category. Others considered
it an ``other'' category that was counter to the goal of clarifying the
need for home health.
A significant goal of the PDGM is to clearly define what types of
services are provided in home health and accurately ascribe payment to
resource use. Our analysis showed that there are four very broad
categories of interventions frequently provided in the home that are
not attributable to one specific intervention or diagnosis: Health
teaching; guidance and counseling; case management; treatments and
procedures; and surveillance. These categories cross the spectrum of
diagnoses, medications, and interventions, which understandably is why
this clinical grouping represents the majority of home health episodes.
We believe that these four broad categories of interventions in MMTA
cannot be underestimated in importance. We stated in the CY 2018 HH PPS
proposed rule that many home health patients have multi-morbidity and
polypharmacy, making education and surveillance crucial in the
management of the home health patient in order to prevent medication
errors and adverse effects. However, the principal diagnosis
necessitating home care for these patients may not involve a complex
nursing intervention, behavioral health, rehabilitation, or wound care.
This group represents a broader, but no less important reason for home
care. We believe MMTA is not so much an ``other'' category as much as
it appears to represent the foundation of home health. Many commenters
highlighted the complexity of home health patients; pointing to multi-
morbidity, ``quicker and sicker'' discharges, and polypharmacy as
important factors in maintaining home health access. CMS agrees that
these issues alone are important reasons for ordering home health
services and necessitate their own clinical grouping.
When initially developing the model, we looked at breaking MMTA
into subgroups in order to account for differences amongst diagnoses
within the broader category of this group. We found that the variation
in resource use was similar across those subgroups and determined
separating diagnoses further would only serve to make the model more
complex and without significant variations in case-mix. However, in
response to public comments and the discussion at the 2018 TEP,\20\ we
performed further analysis on the division of MMTA into subgroups in
order to estimate the payment regression if these groups were separated
from MMTA. We conducted a thorough review of all the diagnosis codes
grouped into MMTA. We then grouped the codes into subgroups based on
feedback from public comments, which mainly focused on cardiac,
oncology, infectious, and respiratory diagnoses. We created the
additional subgroups (Surgical/Procedural Aftercare, Cardiac/
Circulatory, Endocrine, GI/GU, Infectious Diseases/Neoplasms,
Respiratory, and Other) based on data that showed above-average
resource use for the codes in those groups, and then combined certain
groups that had a minimal number of codes. Those results are shown in
Table 38.
---------------------------------------------------------------------------
\20\ https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html.
Table 38--Distribution of Resource Use by 30-Day Periods
[MMTA subgroups]
----------------------------------------------------------------------------------------------------------------
Subgroup N Mean Median
----------------------------------------------------------------------------------------------------------------
Aftercare....................................................... 304,871 $1,605.43 $1,326.03
Cardiac/Circulatory............................................. 1,594,149 1,433.02 1,121.27
Endocrine....................................................... 425,077 1,524.45 1,062.41
GI/GU........................................................... 402,322 1,414.44 1,115.29
Infectious Diseases/Neoplasms/Blood-forming Diseases............ 347,755 1,400.65 1,077.58
Respiratory..................................................... 724,722 1,411.61 1,122.23
Other........................................................... 1,226,750 1,366.56 1,035.76
-----------------------------------------------
Total....................................................... 5,025,646 1,428.17 1,105.20
----------------------------------------------------------------------------------------------------------------
Table 39 shows the impact each MMTA variable has on case-mix
weight. The impact is calculated by taking the regression coefficient
for each variable (unreported here) and dividing by the average
resource use of the 30-day periods in the model. Model 1 shows the
result when MMTA clinical group is not separated into subgroups. Model
1 shows that all else equal, being in MMTA--Low Functional impairment
causes no increase in case-mix weight (for example, a 30-day period's
case-mix weight would be calculated with the coefficients from the
constant of the model plus the admission source/timing of the period
plus the comorbidity adjustment). A 30-day period in MMTA--Medium
Functional would increase the case-mix weight by 0.1560. A 30-day
period in MMTA--High Functional would increase the case-mix weight by
0.2731. Model 2 shows the same information but now includes the MMTA
subgroups. In any given functional level, many of the MMTA subgroups
have an impact on the case-mix weight that is similar to what is found
in Model 1. For example, a period in MMTA (Other)--Medium Functional
[[Page 32403]]
has an increase in case-mix of 0.1568 (which is very similar to the
0.1560 value found in Model 1). There are some groups like Aftercare,
Endocrine, and GI/GU which show different impacts than Model 1. Also,
to a lesser extent these differences also exist for the ``Infectious
Diseases/Neoplasms/Blood forming Diseases'' and ``Respiratory''
subgroups. Some of these differences are driven by periods which are
paid using an outlier adjustment. Model 3 removes outliers and the
corresponding results for the Endocrine subgroup are very similar to
Model 1. Some differences (for example in Aftercare) persist; however,
the change in case-mix weight remains similar to Model 1.
Table 39--Change in Case-Mix Weight Associated With MMTA Variables
----------------------------------------------------------------------------------------------------------------
Model 1 Model 2 Model 3
-------------------------------- (outliers
excluded)
Change in case- Change in case----------------
mix weight mix weight Change in case-
mix weight
----------------------------------------------------------------------------------------------------------------
Variable
MMTA--Low Functional........................................ 0.000 .............. ..............
MMTA--Medium Functional..................................... 0.1560 .............. ..............
MMTA--High Functional....................................... 0.2731 .............. ..............
MMTA (Other)--Low Functional................................ .............. 0.000 0.000
MMTA (Other)--Medium Functional............................. .............. 0.1568 0.1523
MMTA (Other)--High Functional............................... .............. 0.2896 0.2748
MMTA (Aftercare)--Low Functional............................ .............. -0.1082 -0.1196
MMTA (Aftercare)--Medium Functional......................... .............. 0.0798 0.0701
MMTA (Aftercare)--High Functional........................... .............. 0.2588 0.2491
MMTA (Cardiac/Circulatory)--Low Functional.................. .............. -0.0239 -0.0050
MMTA (Cardiac/Circulatory)--Medium Functional............... .............. 0.1371 0.1652
MMTA (Cardiac/Circulatory)--High Functional................. .............. 0.2737 0.2952
MMTA (Endocrine)--Low Functional............................ .............. 0.1105 0.0282
MMTA (Endocrine)--Medium Functional......................... .............. 0.2859 0.1833
MMTA (Endocrine)--High Functional........................... .............. 0.4071 0.3086
MMTA (GI/GU)--Low Functional................................ .............. -0.0751 -0.0639
MMTA (GI/GU)--Medium Functional............................. .............. 0.0997 0.1256
MMTA (GI/GU)--High Functional............................... .............. 0.1992 0.2231
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)-- .............. -0.0452 -0.0472
Low Functional.............................................
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)-- .............. 0.1068 0.1128
Medium Functional..........................................
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)-- .............. 0.2281 0.2379
High Functional............................................
MMTA (Respiratory)--Low Functional.......................... .............. -0.0501 -0.0488
MMTA (Respiratory)--Medium Functional....................... .............. 0.1027 0.1163
MMTA (Respiratory)--High Functional......................... .............. 0.2241 0.2400
----------------------------------------------------------------------------------------------------------------
The results show that the change in case-mix weight was minimal for
the 30-day periods assigned to these subgroups compared to the case-mix
weights without the subgroups. Additionally, the impact of other
variables in the model (admission source/timing, comorbidity
adjustment) on the final case-mix weights were similar whether or not
MMTA subgroups were used.
Overall, using the MMTA subgroup model would result in more payment
groups but not dramatic differences in case-mix weights across those
groups. For this reason, we are not proposing to divide the MMTA
clinical group into subgroups and to leave them as is shown in Table
40. However, we are soliciting comments from the public on whether
there may be other compelling reasons why MMTA should be broken out
into subgroups as shown in Table 38, even if the additional subgroups
do not result in significant differences in case-mix weights across
those subgroups. We note that we also plan continue to examine trends
in reporting and resource utilization to determine if future changes to
the clinical groupings are needed after implementation of the PDGM.
Table 40--Proposed Clinical Groups Used in the PDGM
------------------------------------------------------------------------
The primary reason for the home
Clinical groups health encounter is to provide:
------------------------------------------------------------------------
Musculoskeletal Rehabilitation.... Therapy (physical, occupational or
speech) for a musculoskeletal
condition.
Neuro/Stroke Rehabilitation....... Therapy (physical, occupational or
speech) for a neurological
condition or stroke.
Wounds--Post-Op Wound Aftercare Assessment, treatment & evaluation
and Skin/Non-Surgical Wound Care. of a surgical wound(s); assessment,
treatment & evaluation of non-
surgical wounds, ulcers, burns, and
other lesions.
Behavioral Health Care............ Assessment, treatment & evaluation
of psychiatric conditions,
including substance use disorders.
Complex Nursing Interventions..... Assessment, treatment & evaluation
of complex medical & surgical
conditions including IV, TPN,
enteral nutrition, ventilator, and
ostomies.
Medication Management, Teaching Assessment, evaluation, teaching,
and Assessment (MMTA). and medication management for a
variety of medical and surgical
conditions not classified in one of
the above listed groups.
------------------------------------------------------------------------
[[Page 32404]]
7. Functional Levels and Corresponding OASIS Items
As part of the overall payment adjustment under an alternative
case-mix adjustment methodology, in the CY 2018 Home Health Prospective
Payment System proposed rule (82 FR 35317), we proposed including a
functional level adjustment to account for the resource costs
associated with providing home health care to those patients with
functional impairments. Research has shown a relationship exists
between functional status, rates of hospital readmission, and the
overall costs of health care services.\42\ Functional status is defined
in a number of ways, but generally, functional status reflects an
individual's ability to carry out activities of daily living (ADLs) and
to participate in various life situations and in society.\43\ CMS
currently requires the collection of data on functional status in home
health through a standardized assessment instrument: The Outcome and
Assessment Information Set (OASIS). Under the current HH PPS, a
functional status score is derived from the responses to those items
and this score contributes to the overall case-mix adjustment for a
home health episode payment.
---------------------------------------------------------------------------
\42\ Burke, R. MD, MS, Whitfield, E. Ph.D., Hittle, D. Ph.D.,
Min, S. Ph.D., Levy, C. MD, Ph.D., Prochazka, A. MD, MS, Coleman, E.
MD, MPH, Schwartz, R. MD, Ginde, A. (2016). ``Hospital Readmission
From Post-Acute Care Facilities: Risk Factors, Timing, and
Outcomes''. The Journal of Post-Acute Care and Long Term Care
Medicine. (17), 249-255.
\43\ Clauser, S. Ph.D., and Arlene S. Bierman, M.D., M.S.
(2003). ``Significance of Functional Status Data for Payment and
Quality''. Health Care Financing Review. 24(3), 1-12.
---------------------------------------------------------------------------
Including functional status in the case-mix adjustment methodology
allows for higher payment for those patients with higher service needs.
As functional status is commonly used for risk adjustment in various
payment systems, including in the current HH PPS, we proposed that the
alternative case-mix adjustment methodology would also adjust payments
based on responses to selected functional OASIS items that have
demonstrated higher resource use. Therefore, we examined every OASIS
item for potential inclusion in the alternative case-mix adjustment
methodology including those items associated with functional status.
Generally, worsening functional status is associated with higher
resource use, indicating that the responses to functional OASIS items
may be useful as adjustors to construct case-mix weights for an
alternative case-mix adjustment methodology. However, due to the lack
of variation in resource use across certain responses and because
certain responses were infrequently chosen, we combined some responses
into larger response categories to better capture the relationship
between worsening functional status and resource use. The resulting
combinations of responses for these OASIS items are found at Exhibit 7-
2 in the HHGM technical report, ``Overview of the Home Health Groupings
Model,'' on the HHA Center web page.\44\
---------------------------------------------------------------------------
\44\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------
Each OASIS item included in the final model has a positive
relationship with resource use, meaning as functional status declines
(as measured by a higher response category), periods have more resource
use, on average. As such, in the CY 2018 HH PPS proposed rule, we
proposed that the following OASIS items would be included as part of
the functional level adjustment under an alternative case-mix
adjustment methodology:
M1800: Grooming.
M1810: Current Ability to Dress Upper Body.
M1820: Current Ability to Dress Lower Body.
M1830: Bathing.
M1840: Toilet Transferring.
M1850: Transferring.
M1860: Ambulation/Locomotion.
M1033 Risk of Hospitalization (at least four responses
checked, excluding responses #8, #9, and #10).\45\
---------------------------------------------------------------------------
\45\ Exclusions of the OASIS C-1 Item M1033 include, response
#8: ``currently reports exhaustion''; response #9: ``other risk(s)
not listed in 1-8; response #10: None of the above.
---------------------------------------------------------------------------
In the CY 2018 HH PPS proposed rule, we discussed how under the
HHGM a home health period of care receives points based on each of the
responses associated with the proposed functional OASIS items which are
then converted into a table of points corresponding to increased
resource use. That is, the higher the points, the higher the functional
impairment. The sum of all of these points' results in a functional
impairment score which is used to group home health periods into a
functional level with similar resource use. We proposed three
functional impairment levels of low, medium, and high with
approximately one third of home health periods from each of the
clinical groups within each level. This means home health periods in
the low impairment level have responses for the proposed functional
OASIS items that are associated with the lowest resource use on
average. Home health periods in the high impairment level have
responses for the proposed functional OASIS items that are associated
with the highest resource use on average. We also proposed that the
functional impairment level thresholds would vary between the clinical
groups to account for the patient characteristics within each clinical
group associated with increased resource costs affected by functional
impairment. We provided a detailed analysis of the development of the
functional points and the functional impairment level thresholds by
clinical group in the HHGM technical report \46\ and in Tables 36 and
37 in the CY 2018 HH PPS proposed rule (82 FR 35321).
---------------------------------------------------------------------------
\46\ ``Medicare Home Health Prospective Payment System: Case-Mix
Methodology Refinements Overview of the Home Health Groupings
Model'' located at https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------
In the CY 2018 HH PPS proposed rule, we solicited comments on the
proposed functional OASIS items, the associated points, and the
thresholds by clinical group used to group patients into three
functional impairment levels under the HHGM, as outlined above. The
majority of comments received were from physical therapists, physical
therapy assistants, occupational therapists, and national physical,
occupational, and speech-language pathology associations. Likewise, a
Technical Expert Panel (TEP) was convened in February 2018 to collect
perspectives, feedback, and identify and prioritize recommendations
from a wide variety of industry experts and patient representatives
regarding the public comments received on the proposed HHGM. Comments
were very similar between those received on the CY 2018 HH PPS proposed
rule and those made by the TEP participants.
Most commenters agreed that the level of functional impairment
should be included as part of the overall case-mix adjustment in a
revised case-mix model. Likewise, commenters were generally supportive
of the OASIS items selected to be used in the functional level payment
adjustment. Commenters noted that the role of patient characteristics
and functional status as an indicator of resource use is a well-
established principle in rehabilitation care. Some commenters stated
that adopting a similar component in the home health payment system
will help to remove the incentive to provide unnecessary therapy
services to reach higher classifications for payment but will also move
the HH PPS toward greater consistency with other post-acute care
prospective payment systems. Other comments received on the functional
impairment level adjustment
[[Page 32405]]
encompassed several common themes: The effect of the IMPACT Act
provisions on the HHGM; adequacy of the functional impairment
thresholds and corresponding payment adjustments; potential HHA
behavioral changes to the provision of home health services; the impact
of the removal of therapy thresholds on HHAs; and recommendations for
the inclusion of other OASIS items into the functional impairment level
adjustment.
We note that the analysis presented in the CY 2018 HH PPS proposed
rule was based on CY 2016 home health episodes using version OASIS-C1/
ICD-10 data set, which did not include the aforementioned IMPACT Act
functional items. To accommodate new data being collected for the Home
Health Quality Reporting Program in support of the IMPACT Act, CMS has
proposed to add the functional items, Section GG, ``Functional
Abilities and Goals'', to the OASIS data set effective January 1, 2019.
Because these GG functional items are not required to be collected on
the OASIS until January 1, 2019, we do not have the data to determine
the effect, if any, of these newly added items on resource costs during
a home health period of care. However, if the alternative case-mix
adjustment methodology, is implemented in CY 2020, we would continue to
examine the effects of all OASIS items, including the ``GG'' functional
items, on resource use to determine if any refinements are warranted.
Addressing those comments regarding the use and adequacy of the
functional impairment thresholds to adjust payment, we remind
commenters that the structure of categorizing functional impairment
into Low, Medium, and High levels has been part of the home health
payment structure since the implementation of the HH PPS. The current
HH PPS groups' scores are based on functional OASIS items with similar
average resource use within the same functional level, with
approximately a third of episodes classified as low functional score, a
third of episodes are classified as medium functional score, and a
third of episodes are classified as high functional score. Likewise,
the PDGM groups' scores would be based on functional OASIS items with
similar resource use and would have three levels of functional
impairment severity: Low, medium and high. However, the three
functional impairment thresholds vary between the clinical groups to
account for the patient characteristics within that clinical group
associated with increased resource costs affected by functional
impairment. This is to further ensure that payment is more accurately
aligned with actual patient resource needs. As such, we believe the
more granular structure of these functional levels provides the
information needed on functional impairment and allows greater
flexibility for clinicians to tailor a more patient-centered home
health plan of care to meet the individualized needs of their patients.
As HHA-reported OASIS information determines the functional impairment
levels, accurate reporting on the OASIS will help to ensure that the
case-mix adjustment is in alignment with the actual level of functional
impairment.
Concerns regarding HHAs changing the way they provide services to
eligible beneficiaries, specifically therapy services, should be
mitigated by the more granular functional impairment level adjustment
(for example, functional thresholds which vary between each of the
clinical groups). The functional impairment level case-mix payment
adjustment is reflective of the resource costs associated with these
reported OASIS items and therefore ensures greater payment accuracy
based on patient characteristics. We believe that this approach will
help to maintain and could potentially increase access to needed
therapy services. We remind HHAs that the provision of home health
services should be based on patient characteristics and identified care
needs. This could include those patients with complex and/or chronic
care needs, or those patients requiring home health services over a
longer period of time or for which there is no measureable or expected
improvement.
While the majority of commenters agreed that the elimination of
therapy thresholds is appropriate because of the financial incentive to
overprovide therapy services, some commenters indicated that the
reductions in payment for therapy visits could result in a decrease in
HHA viability and could force some HHAs to go out of business, such as
those HHAs that provide more therapy services than nursing. We note
that section 51001(a)(3) of the BBA of 2018 amended section
1894(b)(4)(B) of the Act to prohibit the use of therapy thresholds as
part of the overall case-mix adjustment for CY 2020 and subsequent
years. Consequently, we have no regulatory discretion in this matter.
Several commenters provided recommendations for additional OASIS
items for inclusion to account for functional impairment. Most notably,
commenters suggested adding OASIS items associated with cognition,
instrumental activities of daily living (IADLs), and caregiver support.
The current HH PPS does not use OASIS items associated with cognition,
IADLs, or caregiver support to case-mix adjust for payment.
Nonetheless, the relationship between cognition and functional status
is important and well-documented in health care literature so we
included them in our analysis because they generally have clinical
significance based on research and standards of practice. As described
in the CY 2018 HH PPS proposed rule and the technical report, we
examined every single OASIS item and its effect on costs. These
included those OASIS items associated with cognition, IADLs, and
caregiver support. Only those OASIS items associated with higher
resource costs were considered for inclusion in the functional level
adjustment in the HHGM. Despite commenters' recommendations, the
variables suggested were only minimally helpful in explaining or
predicting resource use and most reduced the amount of actual payment.
As such, we excluded variables associated with cognition, IADLs, and
caregiver support because they would decrease payment for a home health
period of care which is counter to the purpose of a case-mix adjustment
under the HHGM. The complete analysis of all of the OASIS items can be
found in the HHGM technical report on the HHA Center web page.\47\
---------------------------------------------------------------------------
\47\ https://downloads.cms.gov/files/hhgm%20technical%20report%20120516%20sxf.pdf.
---------------------------------------------------------------------------
After careful consideration of all comments received on the
functional level adjustment as part of an alternative case-mix
adjustment methodology, we believe that the three PDGM functional
impairment levels in each of the six clinical groups are designed to
capture the level of functional impairment. We believe that the more
granular nature of the levels of functional impairment by clinical
group would encourage therapists to determine the appropriate services
for their patients in accordance with identified needs rather than an
arbitrary threshold of visits. While the functional level adjustment is
not meant to be a direct proxy for the therapy thresholds, the PDGM has
other case-mix variables to adjust payment for those patients requiring
multiple therapy disciplines or those chronically ill patients with
significant functional impairment. We believe that also accounting for
timing, source of admission, clinical group (meaning the primary reason
the patient requires home health services), and the presence of
comorbidities will provide the necessary adjustments to payment to
ensure that care needs are met based on
[[Page 32406]]
actual patient characteristics. Therefore, we continue to uphold that
the functional impairment level adjustment is sufficient and along with
the other case-mix adjustments, payment will better align with the
costs of providing services.
In summary, we are proposing that the OASIS items identified in the
CY 2018 HH PPS proposed rule would be included as part of the
functional impairment level payment adjustment under the proposed PDGM.
These items are:
M1800: Grooming.
M1810: Current Ability to Dress Upper Body.
M1820: Current Ability to Dress Lower Body.
M1830: Bathing.
M1840: Toilet Transferring.
M1850: Transferring.
M1860: Ambulation/Locomotion.
M1033: Risk of Hospitalization.\48\
---------------------------------------------------------------------------
\48\ In Version OASIS C-2 (effective 1/1/2018), three responses
are excluded: #8:``currently reports exhaustion'', #9: ``other risks
not listed in 1-8'', and #10: ``None of the above''.
---------------------------------------------------------------------------
We are proposing that a home health period of care receives points
based on each of the responses associated with the proposed functional
OASIS items which are then converted into a table of points
corresponding to increased resource use (See Table 41). The sum of all
of these points results in a functional score which is used to group
home health periods into a functional level with similar resource use.
We are proposing three functional levels of low impairment, medium
impairment, and high impairment with approximately one third of home
health periods from each of the clinical groups within each functional
impairment level (See Table 42). The CY 2018 HH PPS Proposed rule (82
FR 35320) and the technical report posted on the HHA Center web page
provide a more detailed explanation as to the construction of these
functional impairment levels using the proposed OASIS items.
Table 41--Oasis Points Table for Those Items Associated With Increased Resource Use Using a Reduced Set of Oasis
Items, CY 2017
----------------------------------------------------------------------------------------------------------------
Percent of
periods in
Response category Points (2017) 2017 with this
response
category
----------------------------------------------------------------------------------------------------------------
M1800: Grooming............................... 1............................... 4 56.9
M1810: Current Ability to Dress Upper Body.... 1............................... 6 60.0
M1820: Current Ability to Dress Lower Body.... 1............................... 5 59.3
2............................................. 11.............................. 20.9
M1830: Bathing................................ 1............................... 3 18.0
2............................... 13 53.1
3............................... 21 23.6
M1840: Toilet Transferring.................... 1............................... 4 32.1
M1850: Transferring........................... 1............................... 4 37.8
2............................... 8 59.2
M1860: Ambulation/Locomotion.................. 1............................... 11 25.2
2............................... 13 52.8
3............................... 25 14.8
M1033: Risk of Hospitalization................ 4 or more items checked......... 11 17.8
----------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017(as of March 2, 2018).
Table 42--Thresholds for Functional Levels by Clinical Group, CY 2017
------------------------------------------------------------------------
Points (2017
Clinical group Level of impairment data)
------------------------------------------------------------------------
MMTA.............................. Low................. 0-37
Medium.............. 38-53
High................ 54+
Behavioral Health................. Low................. 0-38
Medium.............. 39-53
High................ 54+
Complex Nursing Interventions..... Low................. 0-36
Medium.............. 37-57
High................ 58+
Musculoskeletal Rehabilitation.... Low................. 0-39
Medium.............. 40-53
High................ 54+
Neuro Rehabilitation.............. Low................. 0-45
Medium.............. 46-61
High................ 62+
Wound............................. Low................. 0-43
Medium.............. 44-63
High................ 64+
------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before
December 31, 2017 (as of March 2, 2018).
[[Page 32407]]
Table 43 shows the average resource use by clinical group and
functional level for CY 2017:
Table 43--Average Resource Use by Clinical Group and Functional Level, CY 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Mean resource Frequency of Percent of deviation of Percentile of Median Percentile of
use periods periods resource use resource use resource use resource use
--------------------------------------------------------------------------------------------------------------------------------------------------------
MMTA--Low............................... $1,236.05 1,650,146 19.1 $1,076.20 $511.06 $907.38 $1,632.74
MMTA--Medium............................ 1,487.24 1,709,484 19.8 1,162.37 628.29 1,202.12 2,020.73
MMTA--High.............................. 1,667.38 1,402,299 16.3 1,274.53 719.29 1,371.99 2,265.39
Behavioral Health--Low.................. 971.26 98,193 1.1 845.25 397.45 686.39 1,285.36
Behavioral Health--Medium............... 1,309.40 93,145 1.1 990.34 557.57 1,064.55 1,784.48
Behavioral Health--High................. 1,485.06 96,899 1.1 1,092.42 653.44 1,233.97 2,027.14
Complex--Low............................ 1,313.78 104,504 1.2 1,194.16 553.50 953.84 1,669.45
Complex--Medium......................... 1,668.06 104,717 1.2 1,415.99 694.35 1,275.32 2,202.65
Complex--High........................... 1,771.05 97,779 1.1 1,527.71 704.28 1,336.79 2,361.61
MS Rehab--Low........................... 1,545.07 587,873 6.8 1,048.07 779.96 1,323.12 2,055.60
MS Rehab--Medium........................ 1,731.15 536,444 6.2 1,111.26 931.97 1,527.46 2,293.96
MS Rehab--High.......................... 1,900.89 469,117 5.4 1,243.84 1,009.66 1,672.76 2,520.57
Neuro--Low.............................. 1,591.74 308,011 3.6 1,163.69 744.21 1,323.86 2,127.18
Neuro--Medium........................... 1,833.25 287,788 3.3 1,271.31 900.27 1,568.22 2,467.92
Neuro--High............................. 1,945.49 303,787 3.5 1,420.56 899.47 1,618.16 2,629.54
Wound--Low.............................. 1,663.25 275,383 3.2 1,271.45 790.83 1,328.52 2,152.26
Wound--Medium........................... 1,893.35 238,063 2.8 1,370.79 927.26 1,550.78 2,475.29
Wound--High............................. 2,044.09 261,144 3.0 1,520.35 975.19 1,644.10 2,669.06
Total............................... 1,570.68 8,624,776 100.0 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
Like the annual recalibration of the case-mix weights under the
current HH PPS, we expect that annual recalibrations would also be made
to the PDGM case-mix weights. If the PDGM is finalized for CY 2020, we
will update the functional points and thresholds using the most current
claims data available. Likewise, we would continue to analyze all of
the components of the case-mix adjustment, including adjustment for
functional status, and would make refinements as necessary to ensure
that payment for home health periods are in alignment with the costs of
providing care. We invite comments on the proposed OASIS items and the
associated points and thresholds used to group patients into three
functional impairment levels under the PDGM, as outlined above.
8. Comorbidity Adjustment
The alternative case-mix adjustment methodology proposed in the CY
2018 HH PPS proposed rule, groups home health periods based on the
primary reason for home health care (principal diagnosis), functional
level, admission source, and timing. To further account for differences
in resource use based on patient characteristics, in the CY 2018 HH PPS
proposed rule, we proposed to use the presence of comorbidities as part
of the overall case-mix adjustment under the alternative case-mix
adjustment methodology. Specifically, we proposed a home health
specific list of comorbidities further refined into broader, body
system-based categories and more granular subcategories to capture
those conditions that affect resource costs during a home health period
of care. The proposed comorbidities included those conditions that
represent more than 0.1 percent of periods and had at least as high as
the median resource use as they indicate a direct relationship between
the comorbidity and resource utilization.
Specifically, we proposed a list based on the principles of patient
assessment by body systems and their associated diseases, conditions,
and injuries to develop larger categories of conditions that identified
clinically relevant relationships associated with increased resource
use. The broad, body system-based categories we proposed to use to
group comorbidities within the HHGM included the following:
Heart Disease
Respiratory Disease
Circulatory Disease and Blood Disorders
Cerebral Vascular Disease
Gastrointestinal Disease
Neurological Disease and Associated Conditions
Endocrine Disease
Neoplasms
Genitourinary and Renal Disease
Skin Disease
Musculoskeletal Disease or Injury
Behavioral Health (including Substance Use Disorders)
Infectious Disease
These broad categories used to group comorbidities within the
alternative case-mix adjustment methodology were further refined by
grouping similar diagnoses within the broad categories into
statistically and clinically significant subcategories which would
receive the comorbidity adjustment in the alternative case-mix
adjustment methodology (for example, Heart Disease 1; Cerebral Vascular
Disease 4). All of the comorbidity diagnoses grouped into the
aforementioned categories and subcategories are posted on the Home
Health Agency web page and listed in the HHGM technical report at the
following link: https://www.cms.gov/Center/Provider-Type/Home-Health-
Agency-HHA-Center.html.
We originally proposed that if a 30-day period of care had at least
one secondary diagnosis reported on the home health claim that fell
into one of the subcategories, that 30-day period of care would receive
a comorbidity adjustment to account for higher costs associated with
the comorbidity. Therefore, the payment adjustment for comorbidities
would be predicated on the presence of one of the identified diagnoses
within the subcategories associated with increased resource use at or
above the median. The comorbidity adjustment amount would be the same
[[Page 32408]]
across all of the subcategories. A 30-day period of care would receive
only one comorbidity adjustment regardless of the number of secondary
diagnoses reported on the home health claim that fell into one of the
subcategories associated with higher resource use. If there is no
reported diagnosis that meets the comorbidity adjustment criteria, the
30-day period of care would not qualify for the payment adjustment.
We solicited comments on the proposed comorbidity adjustment in the
CY 2018 HH PPS proposed rule, including the proposed comorbidity
diagnoses and their associated subcategories, as part of the overall
alternative case-mix adjustment methodology. While all commenters
supported the inclusion of a comorbidity adjustment, most commenters
said that a single comorbidity payment amount as part of the overall
case-mix adjustment is insufficient to fully capture the home health
needs and resource costs associated with the presence of comorbidities.
Meeting the requirement of section 51001 of the BBA of 2018, a
Technical Expert Panel (TEP) was convened in February 2018 to collect
perspectives, feedback, and identify and prioritize recommendations
from a wide variety of industry experts and patient representatives
regarding the public comments received on the proposed alternative
case-mix adjustment methodology. Comments on the comorbidity adjustment
and suggestions for refinement to this adjustment were very similar
between those received on the CY 2018 HH PPS proposed rule and those
made by the TEP participants. Specifically, the majority of commenters
stated that the presence of multiple comorbidities has more of an
effect on home health resource use than a single comorbidity and that
any case-mix adjustment should account for multiple comorbidities.
There was general agreement that most home health patients have
multiple conditions which increase the complexity of their care and
affects the ability to care for one's self at home. Several suggested
that CMS should let the data help determine how many comorbidity
adjustment levels there should be and what percentage of 30-day periods
should be in each level. Some commenters stated they preferred
specificity and complexity over simplicity if the complexity improved
accuracy. Others suggested including interactions between comorbidities
in the model, specifically interactions of comorbid conditions with the
principal diagnosis and with other comorbidities. Commenters and TEP
members alike focused on those conditions they saw as most impactful on
the provision of care to home health beneficiaries. These conditions
included chronic respiratory and cardiac conditions, as well as
psychological and diabetes-related conditions. Most encouraged CMS to
continue to develop a system to allow for appropriate changes to be
made over time to the list of comorbidity subcategories that would
assign a comorbidity adjustment to a 30-day period of care.
We agree with commenters that the relationship between
comorbidities and resource use can be complex and that a single
adjustment, regardless of the type or number of comorbidities, may be
insufficient to fully capture the resource use of a varied population
of home health beneficiaries. However, we also recognize that adjusting
payment based on the number of reported comorbidities may encourage
HHAs to inappropriately report comorbid conditions in order to increase
payment, regardless of any true impact on the home health plan of care.
Currently, OASIS instructions state that clinicians must list each
diagnosis for which the patient is receiving home care and to enter the
level of highest specificity as required by ICD-10 CM coding
guidelines. These instructions state that clinicians should list
diagnoses in the order that best reflects the seriousness of each
condition and supports the disciplines and services provided.\49\ We
also note that CMS currently uses interaction items as part of the HH
PPS case-mix adjustments. In the CY 2008 HH PPS final rule (72 FR
49772), we added secondary diagnoses and their interactions with the
principal diagnosis as part of the clinical dimension in the overall
case-mix adjustment. However, analysis since then has shown that
nominal case-mix growth became an ongoing issue resulting from the
incentive in the current HH PPS to code only those conditions
associated with clinical points even though the data did not show an
associated increase in resource utilization. Likewise, when we looked
at a multi-morbidity approach to the overall case-mix adjustment to a
home health period of care, for the CY 2018 HH PPS proposed rule our
analysis showed that the reporting of secondary diagnoses on home
health claims was not robust enough to support a payment adjustment
based on the presence of multiple comorbidities. This means that the
data did not show significant variations in resource use with an
increase in reported comorbidities.
---------------------------------------------------------------------------
\49\ ``Outcome and Assessment I OASIS Information Set C2
Guidance Manual Effective January 1, 2018 accessed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-C2-Guidance-Manual-Effective_1_1_18.pdf.
---------------------------------------------------------------------------
In spite of concerns of potential manipulation of coding patterns
to increase payment due to the comorbidity adjustment, the results of
our most recent analyses for this proposed rule show compelling
evidence that patients with certain comorbidities and interactions of
certain comorbid conditions (as described later in this section) have
home health episodes with higher resource use than home health episodes
without those comorbidities or interactions. The goal of our analyses
was to identify those clinically and statistically significant
comorbidities and interactions that could be used to further case-mix
adjust a 30-day home health period of care. As a result of these
analyses, we identified that there were certain individual comorbidity
subgroups and interactions of the comorbidity subgroups (for example,
having diagnoses associated with two of the comorbidity subgroups)
which could be used as part of the comorbidity case-mix adjustment in
the PDGM.
To identify these relationships with resource utilization, we
looked at all diagnoses reported on the OASIS (M1021, M1023, and M1025)
for each 30-day period of care. These fields represent 18 different
diagnoses which could be reported on the OASIS. In the PDGM, the
principal diagnosis assigns each 30-day period of care into a clinical
group which identifies the primary reason the patient requires home
health services. During our analysis, this usually was the reported
principal diagnosis, but in cases where the diagnosis did not link to a
clinical group (for example, the diagnosis could not be reported as a
principal diagnosis in accordance with ICD-10 CM coding guidelines), we
used a secondary diagnosis to assign the 30-day period of care into a
clinical group. Any other diagnoses, except the one used to link the
30-day period of care into a clinical group, were considered
comorbidities. However, if one of those comorbid diagnoses was in the
same ICD-10 CM block of codes as the diagnosis used to place the 30-day
period of care into a clinical group, then that comorbid diagnosis was
excluded (for example, if the reported principal diagnosis was I63.432,
Cerebral infarction due to embolism of left post cerebral artery, and
the reported secondary diagnosis was I65.01, Occlusion and stenosis of
right vertebral artery, I65.01 would be excluded as a comorbidity as
both codes are in the same block of ICD-10
[[Page 32409]]
diagnosis codes, Cerebrovascular Diseases, and both would group into
the Neuro clinical group if reported as the principal diagnosis). Then,
we checked those reported comorbid diagnoses against the home health-
specific comorbidity subgroup list to see if any reported secondary
diagnoses are listed in a subgroup (for example, if a reported
secondary diagnosis was I50.9, Heart Failure, unspecified, this
diagnosis is found in the Heart 11 subgroup).
We went through the following steps to determine which individual
comorbidity subgroups would be used as part of the comorbidity
adjustment:
After dropping the comorbidity subgroups with a small
number of 30-day periods of care (for example, those that made up fewer
than 0.1 percent of 30-day periods of care), this left 59 different
comorbidity subgroups.
Of those, there are 56 comorbidity subgroups with a p-
value less than or equal to 0.05.
Of those 56 subgroups, there are 22 comorbidity subgroups
that have a positive coefficient when regressing resource use on the
comorbidity subgroups (and the interactions as described below) and
indicators for the clinical group, functional level, admission source,
and timing. We determine the median coefficient of those 22 comorbidity
subgroups to be $60.67.
There are 11 comorbidity subgroups with coefficients that
are at or above the median (for example, $60.67 or above). This is a
decrease from the 15 subgroups presented in the CY 2018 HH PPS proposed
rule. Potential reasons for this decrease include the use of CY 2017
data in this analysis, whereas the 2018 HH PPS proposed rule used CY
2016 data; the combination and/or addition of comorbidity groups; and
the inclusion of the interactions between the comorbidities.
Those 11 individual comorbidity subgroups that are statistically
and clinically significant for potential inclusion in the comorbidity
case-mix adjustment are listed below in Table 44:
Table 44--Individual Subgroups for Comorbidity Adjustment
------------------------------------------------------------------------
Comorbidity subgroup Description Coefficient
------------------------------------------------------------------------
Neuro 11..................... Includes diabetic $61.23
retinopathy and other
blindness.
Neuro 10..................... Includes diabetic 67.98
neuropathies.
Circulatory 9................ Includes acute and 86.62
chronic embolisms and
thrombosis.
Heart 11..................... Includes heart failure... 101.57
Cerebral 4................... Includes sequelae of 128.78
cerebrovascular diseases.
Neuro 5...................... Includes Parkinson's 144.99
Disease.
Skin 1....................... Includes cutaneous 174.93
abscess, cellulitis, and
lymphangitis.
Neuro 7...................... Includes hemiplegia, 204.42
paraplegia, and
quadriplegia.
Circulatory 10............... Includes varicose veins 215.67
with ulceration.
Skin 3....................... Include diseases of 365.78
arteries, arterioles and
capillaries with
ulceration and non-
pressure chronic ulcers.
Skin 4....................... Includes stages Two-Four 484.83
and unstageable pressure
ulcers by site.
------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before
December 31, 2017 (as of March 2, 2018).
Next, we examined the impact of interactions between the various
comorbidity subgroups on resource use. The following steps show how we
identified which interactions (for example, diagnoses from two
different comorbidity subgroups) had a clinically and statistically
significant relationship with increased resource utilization and could
be used for the comorbidity adjustment:
After dropping the combinations of comorbidity subgroups
and interactions with a small number of 30-day periods of care (that
is, those that made up fewer than 0.1 percent of 30-day periods of
care), there are 343 different comorbidity subgroup interactions (for
example, comorbidity subgroup interaction Skin 1 plus Skin 3). As
mentioned previously, we regressed resource use on the comorbidity
subgroups, the interactions, and indicators for the clinical group,
functional level, admission source, and timing.
From that regression, we found 187 comorbidity subgroup
interactions with a p-value less than or equal to 0.05.
Of those 187 comorbidity subgroup interactions, there are
27 comorbidity subgroup interactions where the coefficient on the
comorbidity subgroup interaction term plus the coefficients on both
single comorbidity variables equals a value that exceeds $150. We used
$150 as the inclusion threshold as this amount is approximately three
times that of the median value for the individual comorbidity subgroups
and we believe is appropriate to reflect the increased resource use
associated with comorbidity interactions. The 27 comorbidity subgroup
interactions that are statistically and clinically significant for
potential inclusion in the comorbidity adjustment are listed in Table
45.
Table 45--Comorbidity Subgroup Interactions for Comorbidity Adjustment
----------------------------------------------------------------------------------------------------------------
Sum of
interaction
Comorbidity Comorbidity Comorbidity term plus
subgroup subgroup Description subgroup Description single
interaction comorbidity
coefficients
----------------------------------------------------------------------------------------------------------------
1............... Circulatory 4...... Hypertensive Neuro 11........... Includes diabetic $151.98
Chronic Kidney retinopathy and
Disease. other blindness.
2............... Endocrine 3........ Diabetes with Neuro 7............ Includes 162.35
Complications. hemiplegia,
paraplegia, and
quadriplegia.
3............... Neuro 3............ Dementia in Skin 3............. Diseases of 190.30
diseases arteries,
classified arterioles and
elsewhere. capillaries with
ulceration and
non-pressure
chronic ulcers.
4............... Circulatory 4...... Hypertensive Skin 1............. Cutaneous abscess, 193.33
Chronic Kidney cellulitis, and
Disease. lymphangitis.
5............... Cerebral 4......... Sequelae of Heart 11........... Heart Failure..... 195.55
Cerebrovascular
Diseases.
6............... Neuro 7............ Includes Renal 3............ Nephrogenic 202.44
hemiplegia, Diabetes
paraplegia, and Insipidus.
quadriplegia.
7............... Circulatory 10..... Includes varicose Endocrine 3........ Diabetes with 205.52
veins with Complications.
ulceration.
8............... Heart 11........... Heart Failure..... Neuro 5............ Parkinson's 212.88
Disease.
[[Page 32410]]
9............... Heart 12........... Other Heart Skin 3............. Diseases of 260.83
Diseases. arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
10.............. Neuro 3............ Dementia in Skin 4............. Stages Two-Four 274.16
diseases and unstageable
classified pressure ulcers
elsewhere. by site.
11.............. Behavioral 2....... Mood Disorders.... Skin 3............. Diseases of 287.42
arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
12.............. Circulatory 10..... Includes varicose Heart 11........... Heart Failure..... 292.39
veins with
ulceration.
13.............. Circulatory 4...... Hypertentive Skin 3............. Diseases of 296.70
Chronic Kidney arteries,
Disease. arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
14.............. Renal 1............ Chronic kidney Skin 3............. Diseases of 300.31
disease and ESRD. arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
15.............. Respiratory 5...... COPD and Asthma... Skin 3............. Diseases of 306.63
arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
16.............. Skin 1............. Cutaneous abscess, Skin 3............. Diseases of 390.47
cellulitis, and arteries,
lymphangitis. arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
17.............. Renal 3............ Nephrogenic Skin 4............. Stages Two-Four 422.34
Diabetes and unstageable
Insipidus. pressure ulcers
by site.
18.............. Heart 11........... Heart Failure..... Skin 3............. Diseases of 422.20
arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
19.............. Heart 12........... Other Heart Skin 4............. Stages Two-Four 423.08
Diseases. and unstageable
pressure ulcers
by site.
20.............. Respiratory 5...... COPD and Asthma... Skin 4............. Stages Two-Four 428.02
and unstageable
pressure ulcers
by site.
21.............. Circulatory 7...... Atherosclerosis... Skin 3............. Diseases of 432.46
arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
22.............. Renal 1............ Chronic kidney Skin 4............. Stages Two-Four 436.39
disease and ESRD. and unstageable
pressure ulcers
by site.
23.............. Endocrine 3........ Diabetes with Skin 4............. Stages Two-Four 487.96
Complications. and unstageable
pressure ulcers
by site.
24.............. Endocrine 3........ Diabetes with Skin 3............. Diseases of 504.54
Complications. arteries,
arterioles and
capillaries with
ulceration and
non-pressure
chronic ulcers.
25.............. Circulatory 4...... Hypertensive Skin 4............. Stages Two-Four 509.63
Chronic Kidney and unstageable
Disease. pressure ulcers
by site.
26.............. Heart 11........... Heart Failure..... Skin 4............. Stages Two-Four 529.47
and unstageable
pressure ulcers
by site.
27.............. Skin 3............. Diseases of Skin 4............. Stages Two-Four 750.85
arteries, and unstageable
arterioles and pressure ulcers
capillaries with by site.
ulceration and
non-pressure
chronic ulcers.
----------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
In order to be considered a comorbidity subgroup interaction, at
least two reported diagnoses, must occur in the above corresponding
combinations, as shown in Table 45. For example, one diagnosis from
Heart 11 must be reported along with at least one diagnosis from Neuro
5 in order to qualify for comorbidity subgroup interaction 8. In other
words, the comorbidity subgroups are not interchangeable between the
interaction groups (for example, reported conditions from the Renal 1
and Respiratory 5 subgroups would not be considered an interaction for
purposes of the comorbidity adjustment).
For illustrative purposes, this would mean that if a 30-day period
of care had the following secondary diagnoses reported, I50.22, chronic
systolic (congestive) heart failure and G20, Parkinson's Disease (these
diagnoses fall under comorbidity subgroups Heart 11 and Neuro 5
respectively and are in the same comorbidity subgroup interaction),
this interaction of comorbid conditions results in a higher level of
resource use than just having a comorbid diagnosis classified in Heart
11 or in Neuro 5. There will be an updated PDGM Grouper Tool posted on
the HHA Center web page that HHAs can access to simulate the HIPPS code
and case-mix weight under the PDGM.\50\ This Grouper Tool allows
providers to fill in information, including the comorbidities, to
determine whether a home health period of care would receive a
comorbidity adjustment under the PDGM.
---------------------------------------------------------------------------
\50\ https://www.cms.gov/Center/Provider-Type/Home-Health-
Agency-HHA-Center.html.
---------------------------------------------------------------------------
The comorbidity interactions identify subgroup combinations of
comorbidities that are associated with higher levels of resource use.
As such, we believe that the comorbidity adjustment payment should be
dependent on whether the 30-day period of care has an individual
comorbidity subgroup associated with higher resource use or there is a
comorbidity subgroup interaction resulting in higher resource use.
Therefore, we propose to have three levels in the PDGM comorbidity
case-mix adjustment: No Comorbidity Adjustment, Low Comorbidity
Adjustment, and High Comorbidity Adjustment. This means that depending
on if and which secondary diagnoses are reported, a 30-day period of
care may receive no comorbidity adjustment (meaning, no secondary
diagnoses exist or do not meet the criteria for a comorbidity
adjustment), a ``low'' comorbidity adjustment, or a ``high''
comorbidity adjustment. We propose that home health 30-day periods of
care can receive a comorbidity payment adjustment under the following
circumstances:
Low comorbidity adjustment: There is a reported secondary
diagnosis that falls within one of the home-health specific individual
comorbidity subgroups, as listed in Table 44, (for example, Heart
Disease 11, Cerebral Vascular Disease 4, etc.) associated with higher
resource use, or;
High comorbidity adjustment: There are two or more
secondary diagnoses reported that fall within the
[[Page 32411]]
same comorbidity subgroup interaction, as listed in Table 45, (for
example, Heart 11 plus Neuro 5) that are associated with higher
resource use.
Under the PDGM, a 30-day period of care can receive payment for a
low comorbidity adjustment or a high comorbidity adjustment, but not
both. A 30-day period of care can receive only one low comorbidity
adjustment regardless of the number of secondary diagnoses reported on
the home health claim that fell into one of the individual comorbidity
subgroups or one high comorbidity adjustment regardless of the number
of comorbidity group interactions, as applicable. The low comorbidity
adjustment amount would be the same across all 11 individual
comorbidity subgroups. Similarly, the high comorbidity adjustment
amount would be the same across all 27 comorbidity subgroup
interactions. See Table 48 in section III.F.10 of this proposed rule
for the coefficient amounts associated with both the low and high
comorbidity adjustment, as well as for all of the case-mix variables in
the PDGM. If a 30-day home health period of care does not have any
reported comorbidities that fall into one of the payment adjustments
described above, there would be no comorbidity adjustment applied.
Table 46 illustrates the average resource use for each of the
comorbidity levels as described in this section.
Table 46--Average Resource Use by Comorbidity Adjustment, CY 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standard 25th 75th
Mean resource Frequency of Percent of deviation of percentile of Median percentile of
use periods periods resource use resource use resource use resource use
--------------------------------------------------------------------------------------------------------------------------------------------------------
No Comorbidity Adjustment............... $1,539.92 5,402,694 62.6 $1,183.86 $673.27 $1,253.95 $2,078.68
Comorbidity Adjustment--Has at least one 1,575.12 2,721,969 31.6 1,248.71 658.77 1,262.47 2,131.92
comorbidity from comorbidity list, no
interaction from interaction list......
Comorbidity Adjustment--Has at least one 1,878.84 500,113 5.8 1,412.06 880.07 1,523.87 2,469.93
interaction from interaction list......
---------------------------------------------------------------------------------------------------------------
Total............................... 1,570.68 8,624,776 100.0 1,221.38 679.12 1,272.18 2,117.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
Changing to three comorbidity levels results in 216 possible case-
mix groups for the purposes of adjusting payment in the PDGM. While
this is more case-mix groups than the 144 case-mix groups proposed in
the CY 2018 HH PPS proposed rule, this change is responsive to the
comments received regarding refinements to the comorbidity adjustment
without being unduly complex. We believe that this method for adjusting
payment for the presence of comorbidities is more robust, reflective of
patient characteristics, better aligns payment with actual resource
use, and addresses comments received from the CY 2018 HH PPS proposed
rule and recommendations from TEP members. The comorbidity payment
adjustment takes into account the presence of individual comorbid
conditions, as well as the interactions between multiple comorbid
conditions, and reflects the types of conditions most commonly seen in
home health patients. Similar to monitoring of nominal case-mix growth
under the current HH PPS, upon implementation of the PDGM, CMS will
monitor the reporting of secondary diagnoses to determine whether
adjustments to payment based on the number of reported comorbidities is
resulting in HHAs inappropriately reporting comorbid conditions solely
for the purpose of increased payment and appropriate program integrity
actions will be taken.
As mentioned previously in this section, there will be an updated
PDGM Grouper Tool posted on the HHA Center web page which will be key
to understanding whether a 30-day home health period of care would
receive a no, low, or high comorbidity adjustment under the PDGM. If
implemented, we would continue to examine the relationship of reported
comorbidities on resource utilization and make the appropriate payment
refinements to help ensure that payment is in alignment with the actual
costs of providing care. We invite comments on the change to the
comorbidity case-mix adjustment in the PDGM including the three
comorbidity levels: No Comorbidity, Low Comorbidity, and High
Comorbidity Adjustment. We also invite comments on the payment
associated with the Low Comorbidity and High Comorbidity Adjustment to
account for increased resource utilization resulting from the presence
of certain comorbidities and comorbidity interactions.
9. Change in the Low-Utilization Payment Adjustment (LUPA) Threshold
Currently, a 60-day episode with four or fewer visits is paid the
national per visit amount by discipline, adjusted by the appropriate
wage index based on the site of service of the beneficiary, instead of
the full 60-day episode payment amount. Such payment adjustments are
called Low Utilization Payment Adjustments (LUPAs). While the
alternative case-mix model proposed in the CY 2018 HH PPS proposed rule
still included LUPAs, the approach to calculating the LUPA thresholds
needed to change due to the proposed change in the unit of payment to
30-day periods of care from 60-day episodes. The 30-day periods of care
have substantially more episodes with four or fewer visits than 60-day
episodes. To create LUPA thresholds we proposed in the CY 2018 HH PPS
proposed rule to set the LUPA threshold at the 10th percentile value of
visits or 2, whichever is higher, for each payment group, (82 FR
35324).
We received comments in response to the CY 2018 HH PPS proposed
rule on maintaining the use of a single LUPA threshold instead of
varying the thresholds at the subgroup level. Other commenters
expressed concern that the variable LUPA thresholds will add
[[Page 32412]]
additional administrative burden and create additional opportunity for
error. After analyzing the data to evaluate the potential impact, we
believe that the change to a 30-day period of care under the proposed
PDGM from the current 60-day episode warrants variable LUPA thresholds
depending on the payment group to which it is assigned. We believe that
the proposed LUPA thresholds that vary based on the case-mix assignment
for the 30-day period of care in the proposed PDGM is an improvement
over the current 5 visit threshold that does not vary by case-mix
assignment. This is the same approach proposed in the CY 2018 proposed
rule where LUPA thresholds would vary by case-mix group. LUPA
thresholds that vary by case-mix group take into account different
resource use patterns based on beneficiaries' clinical characteristics.
Additionally, we do not believe that the case-mix-specific LUPA
thresholds would result in additional administrative burden as LUPA
visits are billed the same as non-LUPA periods. Likewise, the PDGM will
not be implemented until January 1, 2020, giving HHAs and vendors
sufficient time to make necessary changes to their systems and to
ensure that appropriate quality checks are in place to minimize any
claims errors. Therefore, we propose to vary the LUPA threshold for a
30-day period of care under the PDGM depending on the PDGM payment
group to which it is assigned.
We note that in the current payment system, approximately 8 percent
of episodes are LUPAs. Under the PDGM, consistent with the CY 2018 HH
PPS proposed rule, we propose the 10th percentile value of visits or 2
visits, whichever is higher, in order to target approximately the same
percentage of LUPAs (approximately 7.1 percent of 30-day periods would
be LUPAs (assuming no behavior change)). For example, for episodes in
the payment group corresponding to ``MMTA- Functional Level Medium--
Early Timing--Institutional Admission--No Comorbidity'' (HIPPS code
2AB1 in Table 47), the threshold is four visits. If a home health 30-
day period of care is assigned to that particular payment group had
three or fewer visits the HHA would be paid using the national per-
visit rates in section III.C.4 of this proposed rule instead of the
case-mix adjusted 30-day period of care payment amount. The LUPA
thresholds for the PDGM payment group with the corresponding HIPPS code
is listed in Table 47.
Table 47--Proposed LUPA Thresholds for the Proposed PDGM Payment Groups
----------------------------------------------------------------------------------------------------------------
Comorbidity
adjustment (0 = Visit threshold
HIPPS Clinical group and Timing and admission none, 1 = single (10th percentile
functional level source comorbidity, 2 = or 2--whichever
interaction) is higher)
----------------------------------------------------------------------------------------------------------------
1AA11...................... MMTA--Low............. Early--Community..... 0 4
1AA21...................... MMTA--Low............. Early--Community..... 1 4
1AA31...................... MMTA--Low............. Early--Community..... 2 4
1AB11...................... MMTA--Medium.......... Early--Community..... 0 4
1AB21...................... MMTA--Medium.......... Early--Community..... 1 4
1AB31...................... MMTA--Medium.......... Early--Community..... 2 5
1AC11...................... MMTA--High............ Early--Community..... 0 4
1AC21...................... MMTA--High............ Early--Community..... 1 4
1AC31...................... MMTA--High............ Early--Community..... 2 4
1BA11...................... Neuro--Low............ Early--Community..... 0 4
1BA21...................... Neuro--Low............ Early--Community..... 1 5
1BA31...................... Neuro--Low............ Early--Community..... 2 5
1BB11...................... Neuro--Medium......... Early--Community..... 0 5
1BB21...................... Neuro--Medium......... Early--Community..... 1 5
1BB31...................... Neuro--Medium......... Early--Community..... 2 5
1BC11...................... Neuro--High........... Early--Community..... 0 4
1BC21...................... Neuro--High........... Early--Community..... 1 5
1BC31...................... Neuro--High........... Early--Community..... 2 5
1CA11...................... Wound--Low............ Early--Community..... 0 4
1CA21...................... Wound--Low............ Early--Community..... 1 4
1CA31...................... Wound--Low............ Early--Community..... 2 4
1CB11...................... Wound--Medium......... Early--Community..... 0 5
1CB21...................... Wound--Medium......... Early--Community..... 1 5
1CB31...................... Wound--Medium......... Early--Community..... 2 5
1CC11...................... Wound--High........... Early--Community..... 0 4
1CC21...................... Wound--High........... Early--Community..... 1 5
1CC31...................... Wound--High........... Early--Community..... 2 4
1DA11...................... Complex--Low.......... Early--Community..... 0 3
1DA21...................... Complex--Low.......... Early--Community..... 1 2
1DA31...................... Complex--Low.......... Early--Community..... 2 4
1DB11...................... Complex--Medium....... Early--Community..... 0 3
1DB21...................... Complex--Medium....... Early--Community..... 1 3
1DB31...................... Complex--Medium....... Early--Community..... 2 4
1DC11...................... Complex--High......... Early--Community..... 0 3
1DC21...................... Complex--High......... Early--Community..... 1 3
1DC31...................... Complex--High......... Early--Community..... 2 3
1EA11...................... MS Rehab--Low......... Early--Community..... 0 5
1EA21...................... MS Rehab--Low......... Early--Community..... 1 5
1EA31...................... MS Rehab--Low......... Early--Community..... 2 5
1EB11...................... MS Rehab--Medium...... Early--Community..... 0 5
1EB21...................... MS Rehab--Medium...... Early--Community..... 1 5
1EB31...................... MS Rehab--Medium...... Early--Community..... 2 5
[[Page 32413]]
1EC11...................... MS Rehab--High........ Early--Community..... 0 5
1EC21...................... MS Rehab--High........ Early--Community..... 1 5
1EC31...................... MS Rehab--High........ Early--Community..... 2 5
1FA11...................... Behavioral Health--Low Early--Community..... 0 3
1FA21...................... Behavioral Health--Low Early--Community..... 1 3
1FA31...................... Behavioral Health--Low Early--Community..... 2 3
1FB11...................... Behavioral Health-- Early--Community..... 0 4
Medium.
1FB21...................... Behavioral Health-- Early--Community..... 1 4
Medium.
1FB31...................... Behavioral Health-- Early--Community..... 2 4
Medium.
1FC11...................... Behavioral Health-- Early--Community..... 0 4
High.
1FC21...................... Behavioral Health-- Early--Community..... 1 4
High.
1FC31...................... Behavioral Health-- Early--Community..... 2 4
High.
2AA11...................... MMTA--Low............. Early--Institutional. 0 3
2AA21...................... MMTA--Low............. Early--Institutional. 1 4
2AA31...................... MMTA--Low............. Early--Institutional. 2 4
2AB11...................... MMTA--Medium.......... Early--Institutional. 0 4
2AB21...................... MMTA--Medium.......... Early--Institutional. 1 5
2AB31...................... MMTA--Medium.......... Early--Institutional. 2 5
2AC11...................... MMTA--High............ Early--Institutional. 0 4
2AC21...................... MMTA--High............ Early--Institutional. 1 4
2AC31...................... MMTA--High............ Early--Institutional. 2 4
2BA11...................... Neuro--Low............ Early--Institutional. 0 5
2BA21...................... Neuro--Low............ Early--Institutional. 1 5
2BA31...................... Neuro--Low............ Early--Institutional. 2 5
2BB11...................... Neuro--Medium......... Early--Institutional. 0 6
2BB21...................... Neuro--Medium......... Early--Institutional. 1 6
2BB31...................... Neuro--Medium......... Early--Institutional. 2 6
2BC11...................... Neuro--High........... Early--Institutional. 0 5
2BC21...................... Neuro--High........... Early--Institutional. 1 5
2BC31...................... Neuro--High........... Early--Institutional. 2 5
2CA11...................... Wound--Low............ Early--Institutional. 0 4
2CA21...................... Wound--Low............ Early--Institutional. 1 4
2CA31...................... Wound--Low............ Early--Institutional. 2 4
2CB11...................... Wound--Medium......... Early--Institutional. 0 5
2CB21...................... Wound--Medium......... Early--Institutional. 1 5
2CB31...................... Wound--Medium......... Early--Institutional. 2 5
2CC11...................... Wound--High........... Early--Institutional. 0 4
2CC21...................... Wound--High........... Early--Institutional. 1 5
2CC31...................... Wound--High........... Early--Institutional. 2 4
2DA11...................... Complex--Low.......... Early--Institutional. 0 3
2DA21...................... Complex--Low.......... Early--Institutional. 1 3
2DA31...................... Complex--Low.......... Early--Institutional. 2 4
2DB11...................... Complex--Medium....... Early--Institutional. 0 4
2DB21...................... Complex--Medium....... Early--Institutional. 1 4
2DB31...................... Complex--Medium....... Early--Institutional. 2 5
2DC11...................... Complex--High......... Early--Institutional. 0 4
2DC21...................... Complex--High......... Early--Institutional. 1 4
2DC31...................... Complex--High......... Early--Institutional. 2 4
2EA11...................... MS Rehab--Low......... Early--Institutional. 0 5
2EA21...................... MS Rehab--Low......... Early--Institutional. 1 5
2EA31...................... MS Rehab--Low......... Early--Institutional. 2 5
2EB11...................... MS Rehab--Medium...... Early--Institutional. 0 6
2EB21...................... MS Rehab--Medium...... Early--Institutional. 1 6
2EB31...................... MS Rehab--Medium...... Early--Institutional. 2 6
2EC11...................... MS Rehab--High........ Early--Institutional. 0 6
2EC21...................... MS Rehab--High........ Early--Institutional. 1 6
2EC31...................... MS Rehab--High........ Early--Institutional. 2 6
2FA11...................... Behavioral Health--Low Early--Institutional. 0 3
2FA21...................... Behavioral Health--Low Early--Institutional. 1 3
2FA31...................... Behavioral Health--Low Early--Institutional. 2 4
2FB11...................... Behavioral Health-- Early--Institutional. 0 4
Medium.
2FB21...................... Behavioral Health-- Early--Institutional. 1 4
Medium.
2FB31...................... Behavioral Health-- Early--Institutional. 2 5
Medium.
2FC11...................... Behavioral Health-- Early--Institutional. 0 4
High.
2FC21...................... Behavioral Health-- Early--Institutional. 1 4
High.
2FC31...................... Behavioral Health-- Early--Institutional. 2 5
High.
3AA11...................... MMTA--Low............. Late--Community...... 0 2
3AA21...................... MMTA--Low............. Late--Community...... 1 2
[[Page 32414]]
3AA31...................... MMTA--Low............. Late--Community...... 2 3
3AB11...................... MMTA--Medium.......... Late--Community...... 0 2
3AB21...................... MMTA--Medium.......... Late--Community...... 1 2
3AB31...................... MMTA--Medium.......... Late--Community...... 2 3
3AC11...................... MMTA--High............ Late--Community...... 0 2
3AC21...................... MMTA--High............ Late--Community...... 1 2
3AC31...................... MMTA--High............ Late--Community...... 2 3
3BA11...................... Neuro--Low............ Late--Community...... 0 2
3BA21...................... Neuro--Low............ Late--Community...... 1 2
3BA31...................... Neuro--Low............ Late--Community...... 2 2
3BB11...................... Neuro--Medium......... Late--Community...... 0 2
3BB21...................... Neuro--Medium......... Late--Community...... 1 2
3BB31...................... Neuro--Medium......... Late--Community...... 2 3
3BC11...................... Neuro--High........... Late--Community...... 0 2
3BC21...................... Neuro--High........... Late--Community...... 1 2
3BC31...................... Neuro--High........... Late--Community...... 2 2
3CA11...................... Wound--Low............ Late--Community...... 0 2
3CA21...................... Wound--Low............ Late--Community...... 1 3
3CA31...................... Wound--Low............ Late--Community...... 2 3
3CB11...................... Wound--Medium......... Late--Community...... 0 3
3CB21...................... Wound--Medium......... Late--Community...... 1 3
3CB31...................... Wound--Medium......... Late--Community...... 2 3
3CC11...................... Wound--High........... Late--Community...... 0 3
3CC21...................... Wound--High........... Late--Community...... 1 3
3CC31...................... Wound--High........... Late--Community...... 2 3
3DA11...................... Complex--Low.......... Late--Community...... 0 2
3DA21...................... Complex--Low.......... Late--Community...... 1 2
3DA31...................... Complex--Low.......... Late--Community...... 2 2
3DB11...................... Complex--Medium....... Late--Community...... 0 2
3DB21...................... Complex--Medium....... Late--Community...... 1 2
3DB31...................... Complex--Medium....... Late--Community...... 2 2
3DC11...................... Complex--High......... Late--Community...... 0 2
3DC21...................... Complex--High......... Late--Community...... 1 2
3DC31...................... Complex--High......... Late--Community...... 2 2
3EA11...................... MS Rehab--Low......... Late--Community...... 0 2
3EA21...................... MS Rehab--Low......... Late--Community...... 1 2
3EA31...................... MS Rehab--Low......... Late--Community...... 2 2
3EB11...................... MS Rehab--Medium...... Late--Community...... 0 2
3EB21...................... MS Rehab--Medium...... Late--Community...... 1 2
3EB31...................... MS Rehab--Medium...... Late--Community...... 2 3
3EC11...................... MS Rehab--High........ Late--Community...... 0 2
3EC21...................... MS Rehab--High........ Late--Community...... 1 2
3EC31...................... MS Rehab--High........ Late--Community...... 2 3
3FA11...................... Behavioral Health--Low Late--Community...... 0 2
3FA21...................... Behavioral Health--Low Late--Community...... 1 2
3FA31...................... Behavioral Health--Low Late--Community...... 2 2
3FB11...................... Behavioral Health-- Late--Community...... 0 2
Medium.
3FB21...................... Behavioral Health-- Late--Community...... 1 2
Medium.
3FB31...................... Behavioral Health-- Late--Community...... 2 2
Medium.
3FC11...................... Behavioral Health-- Late--Community...... 0 2
High.
3FC21...................... Behavioral Health-- Late--Community...... 1 2
High.
3FC31...................... Behavioral Health-- Late--Community...... 2 2
High.
4AA11...................... MMTA--Low............. Late--Institutional.. 0 3
4AA21...................... MMTA--Low............. Late--Institutional.. 1 3
4AA31...................... MMTA--Low............. Late--Institutional.. 2 3
4AB11...................... MMTA--Medium.......... Late--Institutional.. 0 3
4AB21...................... MMTA--Medium.......... Late--Institutional.. 1 3
4AB31...................... MMTA--Medium.......... Late--Institutional.. 2 4
4AC11...................... MMTA--High............ Late--Institutional.. 0 3
4AC21...................... MMTA--High............ Late--Institutional.. 1 3
4AC31...................... MMTA--High............ Late--Institutional.. 2 4
4BA11...................... Neuro--Low............ Late--Institutional.. 0 3
4BA21...................... Neuro--Low............ Late--Institutional.. 1 4
4BA31...................... Neuro--Low............ Late--Institutional.. 2 3
4BB11...................... Neuro--Medium......... Late--Institutional.. 0 4
4BB21...................... Neuro--Medium......... Late--Institutional.. 1 4
4BB31...................... Neuro--Medium......... Late--Institutional.. 2 5
4BC11...................... Neuro--High........... Late--Institutional.. 0 4
[[Page 32415]]
4BC21...................... Neuro--High........... Late--Institutional.. 1 4
4BC31...................... Neuro--High........... Late--Institutional.. 2 4
4CA11...................... Wound--Low............ Late--Institutional.. 0 3
4CA21...................... Wound--Low............ Late--Institutional.. 1 3
4CA31...................... Wound--Low............ Late--Institutional.. 2 3
4CB11...................... Wound--Medium......... Late--Institutional.. 0 4
4CB21...................... Wound--Medium......... Late--Institutional.. 1 4
4CB31...................... Wound--Medium......... Late--Institutional.. 2 4
4CC11...................... Wound--High........... Late--Institutional.. 0 3
4CC21...................... Wound--High........... Late--Institutional.. 1 4
4CC31...................... Wound--High........... Late--Institutional.. 2 4
4DA11...................... Complex--Low.......... Late--Institutional.. 0 2
4DA21...................... Complex--Low.......... Late--Institutional.. 1 3
4DA31...................... Complex--Low.......... Late--Institutional.. 2 3
4DB11...................... Complex--Medium....... Late--Institutional.. 0 3
4DB21...................... Complex--Medium....... Late--Institutional.. 1 3
4DB31...................... Complex--Medium....... Late--Institutional.. 2 4
4DC11...................... Complex--High......... Late--Institutional.. 0 3
4DC21...................... Complex--High......... Late--Institutional.. 1 3
4DC31...................... Complex--High......... Late--Institutional.. 2 3
4EA11...................... MS Rehab--Low......... Late--Institutional.. 0 3
4EA21...................... MS Rehab--Low......... Late--Institutional.. 1 3
4EA31...................... MS Rehab--Low......... Late--Institutional.. 2 3
4EB11...................... MS Rehab--Medium...... Late--Institutional.. 0 4
4EB21...................... MS Rehab--Medium...... Late--Institutional.. 1 4
4EB31...................... MS Rehab--Medium...... Late--Institutional.. 2 4
4EC11...................... MS Rehab--High........ Late--Institutional.. 0 4
4EC21...................... MS Rehab--High........ Late--Institutional.. 1 4
4EC31...................... MS Rehab--High........ Late--Institutional.. 2 4
4FA11...................... Behavioral Health--Low Late--Institutional.. 0 2
4FA21...................... Behavioral Health--Low Late--Institutional.. 1 2
4FA31...................... Behavioral Health--Low Late--Institutional.. 2 2
4FB11...................... Behavioral Health-- Late--Institutional.. 0 3
Medium.
4FB21...................... Behavioral Health-- Late--Institutional.. 1 3
Medium.
4FB31...................... Behavioral Health-- Late--Institutional.. 2 3
Medium.
4FC11...................... Behavioral Health-- Late--Institutional.. 0 3
High.
4FC21...................... Behavioral Health-- Late--Institutional.. 1 3
High.
4FC31...................... Behavioral Health-- Late--Institutional.. 2 4
High.
----------------------------------------------------------------------------------------------------------------
In summary, we propose to vary the LUPA threshold for a 30-day
period of care under the PDGM depending on the PDGM payment group to
which it is assigned. We also propose that the LUPA thresholds for each
PDGM payment group would be re-evaluated every year based on the most
current utilization data available. We invite public comments on the
LUPA threshold methodology proposed for the PDGM and the associated
regulations text changes in section III.F.13 of this proposed rule.
10. HH PPS Case-Mix Weights Under the PDGM
Section 1895(b)(4)(B) requires the Secretary to establish
appropriate case mix adjustment factors for home health services in a
manner that explains a significant amount of the variation in cost
among different units of services. In the CY 2018 HH PPS proposed rule
(82 FR 35270), we proposed an alternative case-mix adjustment
methodology to better align payment with patient care needs. The
proposed alternative case-mix adjustment methodology places patients
into meaningful payment categories based on patient characteristics
(principal diagnosis, functional level, comorbid conditions, referral
source and timing). We did not finalize the alternative case-mix
adjustment methodology in the CY 2018 final rule in order to consider
comments and feedback for any potential refinements to the model.
Refinements were made to the comorbidity case-mix adjustment while all
other variables remain as proposed in the CY 2018 HH PPS proposed rule
(for example, clinical group, functional level, admission source, and
episode timing). As outlined in previous sections of this proposed
rule, we are again proposing an alternative case-mix adjustment
methodology, called the PDGM, but this methodology now results in 216
unique case-mix groups. These 216 unique case-mix payment groups are
called Home Health Resource Groups (HHRGs). In accordance with the BBA
of 2018, the proposed PDGM will be implemented in a budget neutral
manner.
To generate PDGM case-mix weights, we utilized a data file based on
home health episodes of care, as reported in Medicare home health
claims. The claims data provide episode-level data as well as visit-
level data. The claims also provide data on whether non-routine
supplies (NRS) was provided during the episode and the total charges
for NRS. We used CY 2017 home health claims data with linked OASIS
assessment data to obtain patient characteristics. We determined the
case-mix weight for each of the different PDGM payment groups by
regressing
[[Page 32416]]
resource use on a series of indicator variables for each of the
categories using a fixed effects model. The regression measures
resource use with the Cost per Minute (CPM) + NRS approach outlined in
section III.F.2 of this proposed rule. The model used in the PDGM
payment regression generates outcomes that are statistically
significant and consistent with findings.
We received comments in response to the proposed alternative case-
mix adjustment methodology in the CY 2018 HH PPS proposed rule on the
standards for subsequent case-mix weight recalibration (nature and
timing). Similar to the annual recalibration of the case-mix weights
under the current HH PPS, annual recalibration will be made to the PDGM
case-mix weights. We will make refinements as necessary to ensure that
payment for home health periods are in alignment with costs. We note
that this includes a re-calculation of the proposed PDGM case-mix
weights for CY 2020 in the CY 2020 HH PPS proposed rule using CY 2018
home health claims data linked with OASIS assessment data. In other
words, the table below represents the PDGM case-mix weights if we were
to implement the PDGM in CY 2019. However, since we are proposing to
implement the PDGM on January 1, 2020, the actual PDGM case-mix weights
for CY 2020 will be updated in the CY 2020 HH PPS proposed rule. We
also received a comment from MedPAC about the development of
alternative case-mix adjustment methodology using the regression
approach, which is a statistical estimate of the cost associated with a
payment group instead of the actual cost. MedPAC stated that this
approach results in estimated payments that may not equal the actual
costs experienced by HHAs. As noted, CMS has used a regression approach
since the inception of the HH PPS in 2000. The regression smoothens
weights compared to a system where each payment group receives a weight
that is based solely on the average resource use of all 30-day periods
in a payment group compared to the overall average resource use across
all 30 day periods. Smoothing the weights helps to see relationships
between variables and foresee trends. In addition, using a regression
approach to calculate case-mix weights allows CMS to use a fixed
effects model, which will estimate the variation observed within
individual HHAs and opposed to estimating the variation across HHAs.
With the fixed effects, the coefficients should better estimate the
relationship the regression variables have with resource use compared
to not accounting for fixed effects. We continue to believe that using
a regression approach for the calculation of the HH PPS case-mix
weights is most appropriate.
After best fitting the model on home health episodes from 2017
data, we used the estimated coefficients of the model to predict the
expected average resource use of each episode based on the five PDGM
categories. In order to normalize the results, we have divided the
regression predicted resource use of each episode by the overall
average resource use of all episodes used to estimate the model in
order to calculate the case mix weight of all episodes within a
particular payment group, where each payment group is defined as the
unique combination of the subgroups within the five PDGM categories
(admission source, timing of the 30-day period, clinical grouping,
functional level, and comorbidity adjustment). The case-mix weight is
then used to adjust the base payment rate to determine each period's
payment. Table 48 shows the coefficients of the payment regression used
to generate the weights, and the coefficients divided by average
resource use. Information can be found in section III.F.6 of this rule
for the clinical groups, section III.F.7 of this rule for the
functional levels, section III.F.5 for admission source, section
III.F.4 for timing, and section III.F.8 for the comorbidity adjustment.
Table 48--Coefficient of Payment Regression and Coefficient Divided by
Average Resource Use for PDGM Payment Group
------------------------------------------------------------------------
Coefficient
divided by
Variable Coefficient average
resource use
------------------------------------------------------------------------
Clinical Group and Functional Level (MMTA--Low is excluded)
------------------------------------------------------------------------
MMTA--Medium Functional................. $237.83 0.1514
MMTA--High Functional................... 416.75 0.2653
Behavioral Health--Low Functional....... -116.39 -0.0741
Behavioral Health--Medium Functional.... 169.86 0.1081
Behavioral Health--High Functional...... 309.97 0.1974
Complex--Low Functional................. -27.39 -0.0174
Complex--Medium Functional.............. 331.88 0.2113
Complex--High Functional................ 476.69 0.3035
MS Rehab--Low Functional................ 141.37 0.0900
MS Rehab--Medium Functional............. 338.96 0.2158
MS Rehab--High Functional............... 558.95 0.3559
Neuro--Low Functional................... 329.19 0.2096
Neuro--Medium Functional................ 593.98 0.3782
Neuro--High Functional.................. 711.48 0.4530
Wound--Low Functional................... 368.43 0.2346
Wound--Medium Functional................ 628.37 0.4001
Wound--High Functional.................. 822.84 0.5239
------------------------------------------------------------------------
Referral Source With Timing (Community Early excluded)
------------------------------------------------------------------------
Community--Late......................... -646.84 -0.4118
Institutional--Early.................... 278.85 0.1775
Institutional--Late..................... 45.71 0.0291
------------------------------------------------------------------------
[[Page 32417]]
Comorbidity Adjustment (No Comorbidity Adjustment Group is excluded)
------------------------------------------------------------------------
Comorbidity Adjustment--Has at least one 92.44 0.0589
comorbidity from comorbidity list, no
interaction from interaction list......
Comorbidity Adjustment--Has at least one 345.20 0.2198
interaction from interaction list......
------------------------------------------------------------------------
------------------------------------------------------------------------
Constant............................... $1,560.37 0.9934
Average Resource Use.................... $1,570.68 ..............
N....................................... 8,624,776 ..............
Adj. R-Squared.......................... 0.2925 ..............
------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before
December 31, 2017 (as of March 2, 2018) for which we had a linked
OASIS assessment. LUPA episodes, outlier episodes, and episodes with
PEP adjustments were excluded.
Table 49 presents the case-mix weight for each HHRG in the
regression model (Table 48). LUPA episodes, outlier episodes, and
episodes with PEP adjustments were excluded. Please find LUPA
information in section III.F.9 of this rule. Weights are determined by
first calculating the predicted resource use for episodes with a
particular combination of admission source, episode timing, clinical
grouping, functional level, and comorbidity adjustment. This
combination specific calculation is then divided by the average
resource use of all the episodes that were used to estimate the
standard 30-day payment rate, which is $1,570.68. The resulting ratio
represents the case-mix weight for that particular combination of a
HHRG payment group. The adjusted R-squared value for this model is
0.2925 which is slightly higher than the adjusted R-squared value of
0.2704 that we proposed in CY 2018 by using the CY 2016 claims data.
The adjusted R-squared value provides a measure of how well observed
outcomes are replicated by the model, based on the proportion of total
variation of outcomes explained by the model.
As noted above, there are 216 different HHRG payment groups under
the PDGM. There are 15 HHRG payment groups that represent roughly 50.2
percent of the total episodes. There are 61 HHRG payment groups that
represent roughly 1.0 percent of total episodes. The HHRG payment group
with the smallest weight has a weight of 0.5075 (community admitted,
late, behavioral health, low functional impairment level, with no
comorbidity adjustment). The HHRG payment group with the largest weight
has a weight of 1.9146 (institutional admitted, early, wound, high
functional impairment level, with interactive comorbidity adjustment).
Table 49--Case Mix Weights for Each HHRG Payment Group
----------------------------------------------------------------------------------------------------------------
Clinical group and Timing and admission Comorbidity Proposed CY
HIPPS functional level source adjustment 2019 weight
----------------------------------------------------------------------------------------------------------------
1AA11..................... MMTA--Low................ Early--Community......... 0 0.9934
1AA21..................... MMTA--Low................ Early--Community......... 1 1.0523
1AA31..................... MMTA--Low................ Early--Community......... 2 1.2132
1AB11..................... MMTA--Medium............. Early--Community......... 0 1.1449
1AB21..................... MMTA--Medium............. Early--Community......... 1 1.2037
1AB31..................... MMTA--Medium............. Early--Community......... 2 1.3646
1AC11..................... MMTA--High............... Early--Community......... 0 1.2588
1AC21..................... MMTA--High............... Early--Community......... 1 1.3176
1AC31..................... MMTA--High............... Early--Community......... 2 1.4785
1BA11..................... Neuro--Low............... Early--Community......... 0 1.2030
1BA21..................... Neuro--Low............... Early--Community......... 1 1.2619
1BA31..................... Neuro--Low............... Early--Community......... 2 1.4228
1BB11..................... Neuro--Medium............ Early--Community......... 0 1.3716
1BB21..................... Neuro--Medium............ Early--Community......... 1 1.4305
1BB31..................... Neuro--Medium............ Early--Community......... 2 1.5914
1BC11..................... Neuro--High.............. Early--Community......... 0 1.4464
1BC21..................... Neuro--High.............. Early--Community......... 1 1.5053
1BC31..................... Neuro--High.............. Early--Community......... 2 1.6662
1CA11..................... Wound--Low............... Early--Community......... 0 1.2280
1CA21..................... Wound--Low............... Early--Community......... 1 1.2869
1CA31..................... Wound--Low............... Early--Community......... 2 1.4478
1CB11..................... Wound--Medium............ Early--Community......... 0 1.3935
1CB21..................... Wound--Medium............ Early--Community......... 1 1.4523
1CB31..................... Wound--Medium............ Early--Community......... 2 1.6133
1CC11..................... Wound--High.............. Early--Community......... 0 1.5173
1CC21..................... Wound--High.............. Early--Community......... 1 1.5762
1CC31..................... Wound--High.............. Early--Community......... 2 1.7371
1DA11..................... Complex--Low............. Early--Community......... 0 0.9760
[[Page 32418]]
1DA21..................... Complex--Low............. Early--Community......... 1 1.0348
1DA31..................... Complex--Low............. Early--Community......... 2 1.1958
1DB11..................... Complex--Medium.......... Early--Community......... 0 1.2047
1DB21..................... Complex--Medium.......... Early--Community......... 1 1.2636
1DB31..................... Complex--Medium.......... Early--Community......... 2 1.4245
1DC11..................... Complex--High............ Early--Community......... 0 1.2969
1DC21..................... Complex--High............ Early--Community......... 1 1.3558
1DC31..................... Complex--High............ Early--Community......... 2 1.5167
1EA11..................... MS Rehab--Low............ Early--Community......... 0 1.0834
1EA21..................... MS Rehab--Low............ Early--Community......... 1 1.1423
1EA31..................... MS Rehab--Low............ Early--Community......... 2 1.3032
1EB11..................... MS Rehab--Medium......... Early--Community......... 0 1.2092
1EB21..................... MS Rehab--Medium......... Early--Community......... 1 1.2681
1EB31..................... MS Rehab--Medium......... Early--Community......... 2 1.4290
1EC11..................... MS Rehab--High........... Early--Community......... 0 1.3493
1EC21..................... MS Rehab--High........... Early--Community......... 1 1.4082
1EC31..................... MS Rehab--High........... Early--Community......... 2 1.5691
1FA11..................... Behavioral Health--Low... Early--Community......... 0 0.9193
1FA21..................... Behavioral Health--Low... Early--Community......... 1 0.9782
1FA31..................... Behavioral Health--Low... Early--Community......... 2 1.1391
1FB11..................... Behavioral Health--Medium Early--Community......... 0 1.1016
1FB21..................... Behavioral Health--Medium Early--Community......... 1 1.1604
1FB31..................... Behavioral Health--Medium Early--Community......... 2 1.3214
1FC11..................... Behavioral Health--High.. Early--Community......... 0 1.1908
1FC21..................... Behavioral Health--High.. Early--Community......... 1 1.2496
1FC31..................... Behavioral Health--High.. Early--Community......... 2 1.4106
2AA11..................... MMTA--Low................ Early--Institutional..... 0 1.1710
2AA21..................... MMTA--Low................ Early--Institutional..... 1 1.2298
2AA31..................... MMTA--Low................ Early--Institutional..... 2 1.3907
2AB11..................... MMTA--Medium............. Early--Institutional..... 0 1.3224
2AB21..................... MMTA--Medium............. Early--Institutional..... 1 1.3812
2AB31..................... MMTA--Medium............. Early--Institutional..... 2 1.5422
2AC11..................... MMTA--High............... Early--Institutional..... 0 1.4363
2AC21..................... MMTA--High............... Early--Institutional..... 1 1.4951
2AC31..................... MMTA--High............... Early--Institutional..... 2 1.6561
2BA11..................... Neuro--Low............... Early--Institutional..... 0 1.3805
2BA21..................... Neuro--Low............... Early--Institutional..... 1 1.4394
2BA31..................... Neuro--Low............... Early--Institutional..... 2 1.6003
2BB11..................... Neuro--Medium............ Early--Institutional..... 0 1.5491
2BB21..................... Neuro--Medium............ Early--Institutional..... 1 1.6080
2BB31..................... Neuro--Medium............ Early--Institutional..... 2 1.7689
2BC11..................... Neuro--High.............. Early--Institutional..... 0 1.6239
2BC21..................... Neuro--High.............. Early--Institutional..... 1 1.6828
2BC31..................... Neuro--High.............. Early--Institutional..... 2 1.8437
2CA11..................... Wound--Low............... Early--Institutional..... 0 1.4055
2CA21..................... Wound--Low............... Early--Institutional..... 1 1.4644
2CA31..................... Wound--Low............... Early--Institutional..... 2 1.6253
2CB11..................... Wound--Medium............ Early--Institutional..... 0 1.5710
2CB21..................... Wound--Medium............ Early--Institutional..... 1 1.6299
2CB31..................... Wound--Medium............ Early--Institutional..... 2 1.7908
2CC11..................... Wound--High.............. Early--Institutional..... 0 1.6948
2CC21..................... Wound--High.............. Early--Institutional..... 1 1.7537
2CC31..................... Wound--High.............. Early--Institutional..... 2 1.9146
2DA11..................... Complex--Low............. Early--Institutional..... 0 1.1535
2DA21..................... Complex--Low............. Early--Institutional..... 1 1.2124
2DA31..................... Complex--Low............. Early--Institutional..... 2 1.3733
2DB11..................... Complex--Medium.......... Early--Institutional..... 0 1.3823
2DB21..................... Complex--Medium.......... Early--Institutional..... 1 1.4411
2DB31..................... Complex--Medium.......... Early--Institutional..... 2 1.6020
2DC11..................... Complex--High............ Early--Institutional..... 0 1.4745
2DC21..................... Complex--High............ Early--Institutional..... 1 1.5333
2DC31..................... Complex--High............ Early--Institutional..... 2 1.6942
2EA11..................... MS Rehab--Low............ Early--Institutional..... 0 1.2610
2EA21..................... MS Rehab--Low............ Early--Institutional..... 1 1.3198
2EA31..................... MS Rehab--Low............ Early--Institutional..... 2 1.4807
2EB11..................... MS Rehab--Medium......... Early--Institutional..... 0 1.3868
2EB21..................... MS Rehab--Medium......... Early--Institutional..... 1 1.4456
2EB31..................... MS Rehab--Medium......... Early--Institutional..... 2 1.6065
2EC11..................... MS Rehab--High........... Early--Institutional..... 0 1.5268
2EC21..................... MS Rehab--High........... Early--Institutional..... 1 1.5857
[[Page 32419]]
2EC31..................... MS Rehab--High........... Early--Institutional..... 2 1.7466
2FA11..................... Behavioral Health--Low... Early--Institutional..... 0 1.0969
2FA21..................... Behavioral Health--Low... Early--Institutional..... 1 1.1557
2FA31..................... Behavioral Health--Low... Early--Institutional..... 2 1.3166
2FB11..................... Behavioral Health--Medium Early--Institutional..... 0 1.2791
2FB21..................... Behavioral Health--Medium Early--Institutional..... 1 1.3380
2FB31..................... Behavioral Health--Medium Early--Institutional..... 2 1.4989
2FC11..................... Behavioral Health--High.. Early--Institutional..... 0 1.3683
2FC21..................... Behavioral Health--High.. Early--Institutional..... 1 1.4272
2FC31..................... Behavioral Health--High.. Early--Institutional..... 2 1.5881
3AA11..................... MMTA--Low................ Late--Community.......... 0 0.5816
3AA21..................... MMTA--Low................ Late--Community.......... 1 0.6405
3AA31..................... MMTA--Low................ Late--Community.......... 2 0.8014
3AB11..................... MMTA--Medium............. Late--Community.......... 0 0.7330
3AB21..................... MMTA--Medium............. Late--Community.......... 1 0.7919
3AB31..................... MMTA--Medium............. Late--Community.......... 2 0.9528
3AC11..................... MMTA--High............... Late--Community.......... 0 0.8469
3AC21..................... MMTA--High............... Late--Community.......... 1 0.9058
3AC31..................... MMTA--High............... Late--Community.......... 2 1.0667
3BA11..................... Neuro--Low............... Late--Community.......... 0 0.7912
3BA21..................... Neuro--Low............... Late--Community.......... 1 0.8500
3BA31..................... Neuro--Low............... Late--Community.......... 2 1.0110
3BB11..................... Neuro--Medium............ Late--Community.......... 0 0.9598
3BB21..................... Neuro--Medium............ Late--Community.......... 1 1.0186
3BB31..................... Neuro--Medium............ Late--Community.......... 2 1.1796
3BC11..................... Neuro--High.............. Late--Community.......... 0 1.0346
3BC21..................... Neuro--High.............. Late--Community.......... 1 1.0934
3BC31..................... Neuro--High.............. Late--Community.......... 2 1.2544
3CA11..................... Wound--Low............... Late--Community.......... 0 0.8162
3CA21..................... Wound--Low............... Late--Community.......... 1 0.8750
3CA31..................... Wound--Low............... Late--Community.......... 2 1.0360
3CB11..................... Wound--Medium............ Late--Community.......... 0 0.9817
3CB21..................... Wound--Medium............ Late--Community.......... 1 1.0405
3CB31..................... Wound--Medium............ Late--Community.......... 2 1.2015
3CC11..................... Wound--High.............. Late--Community.......... 0 1.1055
3CC21..................... Wound--High.............. Late--Community.......... 1 1.1643
3CC31..................... Wound--High.............. Late--Community.......... 2 1.3253
3DA11..................... Complex--Low............. Late--Community.......... 0 0.5642
3DA21..................... Complex--Low............. Late--Community.......... 1 0.6230
3DA31..................... Complex--Low............. Late--Community.......... 2 0.7840
3DB11..................... Complex--Medium.......... Late--Community.......... 0 0.7929
3DB21..................... Complex--Medium.......... Late--Community.......... 1 0.8518
3DB31..................... Complex--Medium.......... Late--Community.......... 2 1.0127
3DC11..................... Complex--High............ Late--Community.......... 0 0.8851
3DC21..................... Complex--High............ Late--Community.......... 1 0.9440
3DC31..................... Complex--High............ Late--Community.......... 2 1.1049
3EA11..................... MS Rehab--Low............ Late--Community.......... 0 0.6716
3EA21..................... MS Rehab--Low............ Late--Community.......... 1 0.7305
3EA31..................... MS Rehab--Low............ Late--Community.......... 2 0.8914
3EB11..................... MS Rehab--Medium......... Late--Community.......... 0 0.7974
3EB21..................... MS Rehab--Medium......... Late--Community.......... 1 0.8563
3EB31..................... MS Rehab--Medium......... Late--Community.......... 2 1.0172
3EC11..................... MS Rehab--High........... Late--Community.......... 0 0.9375
3EC21..................... MS Rehab--High........... Late--Community.......... 1 0.9963
3EC31..................... MS Rehab--High........... Late--Community.......... 2 1.1573
3FA11..................... Behavioral Health--Low... Late--Community.......... 0 0.5075
3FA21..................... Behavioral Health--Low... Late--Community.......... 1 0.5664
3FA31..................... Behavioral Health--Low... Late--Community.......... 2 0.7273
3FB11..................... Behavioral Health--Medium Late--Community.......... 0 0.6898
3FB21..................... Behavioral Health--Medium Late--Community.......... 1 0.7486
3FB31..................... Behavioral Health--Medium Late--Community.......... 2 0.9095
3FC11..................... Behavioral Health--High.. Late--Community.......... 0 0.7790
3FC21..................... Behavioral Health--High.. Late--Community.......... 1 0.8378
3FC31..................... Behavioral Health--High.. Late--Community.......... 2 0.9987
4AA11..................... MMTA--Low................ Late--Institutional...... 0 1.0225
4AA21..................... MMTA--Low................ Late--Institutional...... 1 1.0814
4AA31..................... MMTA--Low................ Late--Institutional...... 2 1.2423
4AB11..................... MMTA--Medium............. Late--Institutional...... 0 1.1740
4AB21..................... MMTA--Medium............. Late--Institutional...... 1 1.2328
4AB31..................... MMTA--Medium............. Late--Institutional...... 2 1.3937
[[Page 32420]]
4AC11..................... MMTA--High............... Late--Institutional...... 0 1.2879
4AC21..................... MMTA--High............... Late--Institutional...... 1 1.3467
4AC31..................... MMTA--High............... Late--Institutional...... 2 1.5076
4BA11..................... Neuro--Low............... Late--Institutional...... 0 1.2321
4BA21..................... Neuro--Low............... Late--Institutional...... 1 1.2910
4BA31..................... Neuro--Low............... Late--Institutional...... 2 1.4519
4BB11..................... Neuro--Medium............ Late--Institutional...... 0 1.4007
4BB21..................... Neuro--Medium............ Late--Institutional...... 1 1.4595
4BB31..................... Neuro--Medium............ Late--Institutional...... 2 1.6205
4BC11..................... Neuro--High.............. Late--Institutional...... 0 1.4755
4BC21..................... Neuro--High.............. Late--Institutional...... 1 1.5344
4BC31..................... Neuro--High.............. Late--Institutional...... 2 1.6953
4CA11..................... Wound--Low............... Late--Institutional...... 0 1.2571
4CA21..................... Wound--Low............... Late--Institutional...... 1 1.3160
4CA31..................... Wound--Low............... Late--Institutional...... 2 1.4769
4CB11..................... Wound--Medium............ Late--Institutional...... 0 1.4226
4CB21..................... Wound--Medium............ Late--Institutional...... 1 1.4814
4CB31..................... Wound--Medium............ Late--Institutional...... 2 1.6424
4CC11..................... Wound--High.............. Late--Institutional...... 0 1.5464
4CC21..................... Wound--High.............. Late--Institutional...... 1 1.6053
4CC31..................... Wound--High.............. Late--Institutional...... 2 1.7662
4DA11..................... Complex--Low............. Late--Institutional...... 0 1.0051
4DA21..................... Complex--Low............. Late--Institutional...... 1 1.0639
4DA31..................... Complex--Low............. Late--Institutional...... 2 1.2249
4DB11..................... Complex--Medium.......... Late--Institutional...... 0 1.2338
4DB21..................... Complex--Medium.......... Late--Institutional...... 1 1.2927
4DB31..................... Complex--Medium.......... Late--Institutional...... 2 1.4536
4DC11..................... Complex--High............ Late--Institutional...... 0 1.3260
4DC21..................... Complex--High............ Late--Institutional...... 1 1.3849
4DC31..................... Complex--High............ Late--Institutional...... 2 1.5458
4EA11..................... MS Rehab--Low............ Late--Institutional...... 0 1.1125
4EA21..................... MS Rehab--Low............ Late--Institutional...... 1 1.1714
4EA31..................... MS Rehab--Low............ Late--Institutional...... 2 1.3323
4EB11..................... MS Rehab--Medium......... Late--Institutional...... 0 1.2383
4EB21..................... MS Rehab--Medium......... Late--Institutional...... 1 1.2972
4EB31..................... MS Rehab--Medium......... Late--Institutional...... 2 1.4581
4EC11..................... MS Rehab--High........... Late--Institutional...... 0 1.3784
4EC21..................... MS Rehab--High........... Late--Institutional...... 1 1.4373
4EC31..................... MS Rehab--High........... Late--Institutional...... 2 1.5982
4FA11..................... Behavioral Health--Low... Late--Institutional...... 0 0.9484
4FA21..................... Behavioral Health--Low... Late--Institutional...... 1 1.0073
4FA31..................... Behavioral Health--Low... Late--Institutional...... 2 1.1682
4FB11..................... Behavioral Health--Medium Late--Institutional...... 0 1.1307
4FB21..................... Behavioral Health--Medium Late--Institutional...... 1 1.1895
4FB31..................... Behavioral Health--Medium Late--Institutional...... 2 1.3505
4FC11..................... Behavioral Health--High.. Late--Institutional...... 0 1.2199
4FC21..................... Behavioral Health--High.. Late--Institutional...... 1 1.2787
4FC31..................... Behavioral Health--High.. Late--Institutional...... 2 1.4397
----------------------------------------------------------------------------------------------------------------
Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 for which we had a
linked OASIS assessment. LUPA episodes, outlier episodes, and episodes with PEP adjustments were excluded.
In conjunction with the implementation of the PDGM, we are
proposing to revise the frequency with which we update the HH PPS
Grouper software used to assign the appropriate HIPPS code used for
case-mix adjustment onto the claim. Since CY 2004 when the HH PPS moved
from a fiscal year to a calendar year basis, we have updated the
Grouper software twice a year. We provide an updated version of the
Grouper software effective every October 1 in order to address ICD
coding revisions, which are effective on October 1. We also provide an
updated version of the HH PPS Grouper software effective on January 1
in order to capture the new or revised HH PPS policies that become
effective on January 1. In an effort to reduce provider burden
associated with testing and installing two software releases, we
propose to discontinue the October release of the HH PPS Grouper
software and provide a single HH PPS Grouper software release effective
January 1 of each calendar year. We propose that the January release of
the HH PPS Grouper software would include the most recent revisions to
the ICD coding system as well as the payment policy updates contained
in the HH PPS final rule. Therefore, under this proposal, during the
last quarter of each calendar year, HHAs would continue to use the ICD-
10-CM codes and reporting guidelines that they would have used for the
first three calendar quarters. HHAs would begin using the most recent
ICD-10-CM codes and reporting guidelines on home health claims
beginning on January 1 of each calendar year. We are soliciting
comments on this proposal.
We invite comments on the proposed PDGM case-mix weights, case-mix
[[Page 32421]]
weight methodology and proposed annual recalibration of the case-mix
weights, updates to the HH PPS Grouper software, and the associated
regulations text changes in section III.F.13 of this proposed rule.
11. Low-Utilization Payment Adjustment (LUPA) Add-On Payments and
Partial Payment Adjustments Under PDGM
LUPA episodes qualify for an add-on payment in the case that the
established episode is the first or only episode in a sequence of
adjacent episodes. As stated in the CY 2008 HH PPS final rule, LUPA
add-on payments are made because the national per-visit payment rates
do not adequately account for the front-loading of costs for the first
episode of care as the average visit lengths in these initial LUPAs are
16 to 18 percent higher than the average visit lengths in initial non-
LUPA episodes (72 FR 49848). LUPA episodes that occur as the only
episode or as an initial episode in a sequence of adjacent episodes are
adjusted by applying an additional amount to the LUPA payment before
adjusting for area wage differences. Under the PDGM, we propose that
the LUPA add-on factors will remain the same as the current payment
system, described in section III.C.4 of this proposed rule. We multiply
the per-visit payment amount for the first SN, PT, or SLP visit in LUPA
episodes that occur as the only episode or an initial episode in a
sequence of adjacent episodes by the appropriate factor (1.8451 for SN,
1.6700 for PT, and 1.6266 for SLP) to determine the LUPA add-on payment
amount.
The current partial episode payment (PEP) adjustment is a
proportion of the episode payment and is based on the span of days
including the start-of-care date (for example, the date of the first
billable service) through and including the last billable service date
under the original plan of care before the intervening event in a home
health beneficiary's care defined as:
A beneficiary elected transfer, or
A discharge and return to home health that would warrant,
for purposes of payment, a new OASIS assessment, physician
certification of eligibility, and a new plan of care.
We received comments on eliminating PEPs in response to the CY 2018
HH PPS proposed rule. We note that the change in the unit of payment
from 60 days to 30 days will reduce the number of instances where a PEP
adjustment occurs. However, we believe maintaining a PEP adjustment
policy is appropriate to ensure that Medicare is not paying twice for
the same period of care, as the PEP is involved with patient transfers
there is a risk of a duplicate payment error. For example, if a patient
chooses to transfer to a different HHA during the course of a home
health period of care, the payment is proportionally adjusted to
reflect the length of time the beneficiary remained under the agency's
care prior to the intervening event and ensures that Medicare is not
paying two HHAs for the same 30-day period of care.
In summary for 30-day periods of care, we propose that the process
for partial payment adjustments would remain the same as the existing
policies pertaining to partial episode payments. When a new 30-day
period begins due to the intervening event of the beneficiary elected
transfer or discharge and return to home health during the 30-day
episode, the original 30-day period would be proportionally adjusted to
reflect the length of time the beneficiary remained under the agency's
care prior to the intervening event. The proportional payment is the
partial payment adjustment. The partial payment adjustment is
calculated by using the span of days (first billable service date
through and including the last billable service date) under the
original plan of care as a proportion of 30. The proportion is
multiplied by the original case-mix and wage index 30-day payment.
12. Payments for High-Cost Outliers Under the PDGM
As described in section III.E of this proposed rule, section
1895(b)(5) of the Act allows for the provision of an addition or
adjustment to the home health payment amount in the case of outliers
because of unusual variations in the type or amount of medically
necessary care. The history of and current methodology for payment of
high-cost outliers under the HH PPS is described in detail in section
III.E of this proposed rule. In the CY 2018 HH PPS proposed rule (82 FR
35270), we proposed that we would maintain the current methodology for
payment of high-cost outliers upon implementation of a 30-day unit of
payment and that we would calculate payment for high-cost outliers
based upon 30-day periods of care.
Commenters expressed concerns regarding the outlier policy proposed
in the CY 2018 HH PPS proposed rule and the potential for more
providers to exceed the 10 percent outlier cap under a 30-day period of
care. Commenters also suggested modification to the 8-hour cap on the
amount of time per day that is permitted to be counted toward the
estimation of an episode's costs for outlier calculation purposes.
While we appreciate commenters' feedback regarding the proposed
outlier payment policy described in the CY 2018 HH PPS proposed rule,
we are proposing to maintain the existing outlier policy under the
proposed PDGM, except that outlier payments would be determined on a
30-day basis to align with the 30-day unit of payment under the
proposed PDGM. We believe that maintaining the existing outlier policy
and applying such policy to 30-day periods of care would ensure a
smooth transition within the framework of the proposed PDGM. We plan to
closely evaluate and model projected outlier payments within the
framework of the PDGM and consider modifications to the outlier policy
as appropriate. The requirement that the total amount of outlier
payments not exceed 2.5 percent of total home health payments as well
as the 10 percent cap on outlier payments at the home health agency
level are statutory requirements, as described in section 1895(b)(5) of
the Act. Therefore, we do not have the authority to adjust or eliminate
the 10-percent cap or increase the 2.5 percent maximum outlier payment
amount.
Regarding the 8-hour limit on the amount of time per day counted
toward the estimation of an episode's costs, as noted in the CY2017 HH
PPS final rule (81 FR 76729), where a patient is eligible for coverage
of home health services, Medicare statute limits the amount of part-
time or intermittent home health aide services and skilled nursing
services covered during a home health episode. Section 1861(m)(7)(B) of
the Act states that the term `` `part-time or intermittent services'
means skilled nursing and home health aide services furnished any
number of days per week as long as they are furnished (combined) less
than 8 hours each day and 28 or fewer hours each week (or, subject to
review on a case-by-case basis as to the need for care, less than 8
hours each day and 35 or fewer hours per week).'' Therefore, the daily
and weekly cap on the amount of skilled nursing and home health aide
services combined is a limit defined within the statute. As we further
noted in the CY 2018 HH PPS final rule (81 FR 76729), because outlier
payments are predominately driven by the provision of skilled nursing
services, the 8-hour daily cap on services aligns with the statute,
which requires that skilled nursing and home health aide services
combined be furnished less than 8 hours each day. Therefore, we believe
that maintaining the 8-hour per day cap is appropriate under the
proposed PDGM.
[[Page 32422]]
Simulating payments using preliminary CY 2017 claims data and the
CY 2019 payment rates, we estimate that outlier payments under the
proposed PDGM with 30-day periods of care would comprise approximately
4.77 percent of total HH PPS payments in CY 2019. Given the statutory
requirement to target up to, but no more than, 2.5 percent of total
payments as outlier payments, we currently estimate that the FDL ratio
under the proposed PDGM would need to change from 0.55 to 0.71.
However, given the proposed implementation of the PDGM for 30-day
periods of care beginning on or after January 1, 2020, we will update
our estimate of outlier payments as a percent of total HH PPS payments
using the most current and complete utilization data available at the
time of CY 2020 rate-setting.
We invite public comments on maintaining the current outlier
payment methodology outlined in section III.E of this proposed rule for
the proposed PDGM and the associated changes in the regulations text as
described in section III.F.13 of this proposed rule.
13. Conforming Regulations Text Revisions for the Implementation of the
PDGM in CY 2020
We are proposing to make a number of revisions to the regulations
to implement the PDGM for episodes beginning on or after January 1,
2020, as outlined in sections III.F.1 through III.F.12 of this proposed
rule. We propose to make conforming changes in Sec. 409.43 and part
484 Subpart E to revise the unit of service from a 60-day episode to a
30-day period. In addition, we are proposing to restructure Sec.
484.205. These revisions would be effective on January 1, 2020.
Specifically, we propose to:
Revise Sec. 409.43, which outlines plan of care
requirements. We propose to revise several paragraphs to phase out the
unit of service from a 60-day episode for claims beginning on or before
December 31, 2019, and to implement a 30-day period as the new unit of
service for claims beginning on or after January 1, 2020 under the
PDGM. We propose to move and revise paragraph (c)(2) to Sec. 484.205
as paragraph (c)(2) aligns more closely with the regulations addressing
the basis of payment.
Revise the definitions of rural area and urban area in
Sec. 484.202 to remove ``with respect to home health episodes ending
on or after January 1, 2006'' from each definition as this verbiage is
no longer necessary.
Restructure Sec. 484.205 to provide more logical
organization and revise to account for the change in the unit of
payment under the HH PPS for CY 2020. The PDGM uses 30-day periods
rather than the 60-day episode used in the current payment system.
Therefore, we propose to revise Sec. 484.205 to remove references to
``60-day episode'' and to refer more generally to the ``national,
standardized prospective payment''. We are also proposing revisions to
Sec. 484.205 as follows:
++ Add paragraphs to paragraph (b) to define the unit of payment.
++ Move language which addresses the requirement for OASIS
submission from Sec. 484.210 and insert it into Sec. 484.205 as new
paragraph (c).
++ Move paragraph (c)(2) from Sec. 409.43 to Sec. 484.205 as new
paragraph (g) in order to better align with the regulations detailing
the basis of payment.
++ Add paragraph (h) to discuss split percentage payments under the
current model and the proposed PDGM.
We are not proposing to change the requirements or policies
relating to durable medical equipment or furnishing negative pressure
wound therapy using a disposable device.
Remove Sec. 484.210 which discusses data used for the
calculation of the national prospective 60-day episode payment as we
believe that this information is duplicative and already incorporated
in other sections of part 484, subpart E.
Revise the section heading of Sec. 484.215 from ``Initial
establishment of the calculation of the national 60-day episode
payment'' to ``Initial establishment of the calculation of the
national, standardized prospective 60-day episode payment and 30-day
payment rates.'' Also, we propose to add paragraph (f) to this section
to describe how the national, standardized prospective 60-day episode
payment rate is converted into a national, standardized prospective 30-
day period payment and when it applies.
Revise the section heading of Sec. 484.220 from
``Calculation of the adjusted national prospective 60-day episode
payment rate for case-mix and area wage levels'' to ``Calculation of
the case-mix and wage area adjusted prospective payment rates.'' We
propose to remove the reference to ``national 60-day episode payment
rate'' and replace it with ``national, standardized prospective
payment''.
Revise the section heading in Sec. 484.225 from ``Annual
update of the unadjusted national prospective 60-day episode payment
rate'' to ``Annual update of the unadjusted national, standardized
prospective 60-day episode and 30-day payment rates''. Also, we propose
to revise Sec. 484.225 to remove references to ``60-day episode'' and
to refer more generally to the ``national, standardized prospective
payment''. In addition, we propose to add paragraph (d) to describe the
annual update for CY 2020 and subsequent calendar years.
Revise the section heading of Sec. 484.230 from
``Methodology used for the calculation of low-utilization payment
adjustment'' to ``Low utilization payment adjustment''. Also, we
propose to designate the current text to paragraph (a) and insert
language such that proposed paragraph (a) applies to claims beginning
on or before December 31, 2019, using the current payment system. We
propose to add paragraph (b) to describe how low utilization payment
adjustments are determined for claims beginning on or after January 1,
2020, using the proposed PDGM.
Revise the section heading of Sec. 484.235 from
``Methodology used for the calculation of partial episode payment
adjustments'' to ``Partial payment adjustments''. We propose to remove
paragraphs (a), (b), and (c). We propose to remove paragraphs (1), (2),
and (3) which describe partial payment adjustments from paragraph (d)
in Sec. 484.205 and incorporate them into Sec. 484.235. We propose to
add paragraph (a) to describe partial payment adjustments under the
current system, that is, for claims beginning on or before December 31,
2019, and paragraph (b) to describe partial payment adjustments under
the proposed PDGM, that is, for claims beginning on or after January 1,
2020.
Revise the section heading for Sec. 484.240 from
``Methodology used for the calculation of the outlier payment'' to
``Outlier payments.'' In addition, we propose to remove language at
paragraph (b) and append it to paragraph (a). We propose to add
language to proposed revised paragraph (a) such that paragraph (a) will
apply to payments under the current system, that is, for claims
beginning on or before December 31, 2019. We propose to revise
paragraph (b) to describe payments under the proposed PDGM, that is,
for claims beginning on or after January 1, 2020. In paragraph (c), we
propose to replace the ``estimated'' cost with ``imputed'' cost.
Lastly, we propose to revise paragraph (d) to reflect the per-15 minute
unit approach to imputing the cost for each claim.
We are soliciting comments on the proposed PDGM as outlined in
sections III.F.1 through III.F.12 and the associated regulations text
changes
[[Page 32423]]
described above and in section IX of this proposed rule.
G. Proposed Changes Regarding Certifying and Recertifying Patient
Eligibility for Medicare Home Health Services
1. Background
Sections 1814(a) and 1835(a) of the Act require that a physician
certify patient eligibility for home health services (and recertify,
where such services are furnished over a period of time). The
certifying physician is responsible for determining whether the patient
meets the eligibility criteria (that is, homebound status and need for
skilled services) and for understanding the current clinical needs of
the patient such that the physician can establish an effective plan of
care. In addition, as a condition for payment, section 6407 of the
Affordable Care Act amended sections 1814(a)(2)(C) and 1835(a)(2)(A) of
the Act requiring, as part of the certification for home health
services, that prior to certifying a patient's eligibility for the
Medicare home health benefit the certifying physician must document
that the physician himself or herself or an allowed non-physician
practitioner had a face-to-face encounter with the patient. The
regulations at 42 CFR 424.22(a) and (b) set forth the requirements for
certification and recertification of eligibility for home health
services. The regulations at Sec. 424.22(c) provide the supporting
documentation requirements used as the basis for determining patient
eligibility for Medicare home health services.
2. Current Supporting Documentation Requirements
In determining whether the patient is or was eligible to receive
services under the Medicare home health benefit at the start of care,
as of January 1, 2015, we require documentation in the certifying
physician's medical records and/or the acute/post-acute care facility's
medical records (if the patient was directly admitted to home health)
to be used as the basis for certification of home health eligibility as
described at Sec. 424.22(c). Specifically, the certifying physician
and/or the acute/post-acute care facility medical record (if the
patient was directly admitted to home health) for the patient must
contain information that justifies the referral for Medicare home
health services. This includes documentation that substantiates the
patient's:
Need for the skilled services; and
Homebound status;
Likewise, the certifying physician and/or the acute/post-acute care
facility medical record (if the patient was directly admitted to home
health) for the patient must contain the actual clinical note for the
face-to-face encounter visit that demonstrates that the encounter:
Occurred within the required timeframe,
Was related to the primary reason the patient requires
home health services; and
Was performed by an allowed provider type.
This information can be found most often in clinical and progress
notes and discharge summaries. While the face-to-face encounter must be
related to the primary reason for home health services, the patient's
skilled need and homebound status can be substantiated through an
examination of all submitted medical record documentation from the
certifying physician, acute/post-acute care facility, and/or HHA (if
certain requirements are met). The synthesis of progress notes,
diagnostic findings, medications, and nursing notes, help to create a
longitudinal clinical picture of the patient's health status to make
the determination that the patient is eligible for home health
services. HHAs must obtain as much documentation from the certifying
physician's medical records and/or the acute/post-acute care facility's
medical records (if the patient was directly admitted to home health)
as they deem necessary to assure themselves that the Medicare home
health patient eligibility criteria have been met. HHAs must be able to
provide it to CMS and its review entities upon request. If the
documentation used as the basis for the certification of eligibility
(that is, the certifying physician's and/or the acute/post-acute care
facility's medical record documentation) is not sufficient to
demonstrate that the patient is or was eligible to receive services
under the Medicare home health benefit, payment will not be rendered
for home health services provided.
3. Proposed Regulations Text Changes Regarding Information Used to
Satisfy Documentation of Medicare Eligibility for Home Health Services
Section 51002 of the BBA of 2018 amended sections 1814(a) and
1835(a) of the Act to provide that, effective for physician
certifications and recertifications made on or after January 1, 2019,
in addition to using the documentation in the medical record of the
certifying physician or of the acute or post-acute care facility (where
home health services were furnished to an individual who was directly
admitted to the HHA from such facility), the Secretary may use
documentation in the medical record of the HHA as supporting material,
as appropriate to the case involved. We believe the BBA of 2018
provisions are consistent with our existing policy in this area, which
is currently reflected in sub-regulatory guidance in the Medicare
Benefit Policy Manual (Pub.100-02, chapter 7, section 30.5.1.2) and the
Medicare Program Integrity Manual (Pub. 100-08, chapter 6, section
6.2.3).\51\ The sub-regulatory guidance describes the circumstances in
which HHA documentation can be used along with the certifying physician
and/or acute/post-acute care facility medical record to support the
patient's homebound status and skilled need. Specifically, we state
that information from the HHA, such as the plan of care required in
accordance with 42 CFR 409.43 and the initial and/or comprehensive
assessment of the patient required in accordance with 42 CFR 484.55,
can be incorporated into the certifying physician's medical record for
the patient and used to support the patient's homebound status and need
for skilled care. However, this information must be corroborated by
other medical record entries in the certifying physician's and/or the
acute/post-acute care facility's medical record for the patient. This
means that the appropriately incorporated HHA information, along with
the certifying physician's and/or the acute/post-acute care facility's
medical record, creates a clinically consistent picture that the
patient is eligible for Medicare home health services. The certifying
physician officially incorporates the HHA information into his/her
medical record for the patient by signing and dating the material. Once
incorporated, the documentation from the HHA, in conjunction with the
certifying physician and/or acute/post-acute care facility
documentation, must substantiate the patient's eligibility for home
health services.
---------------------------------------------------------------------------
\51\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf and https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c06.pdf.
---------------------------------------------------------------------------
While we believe the provisions in section 51002 of the BBA of 2018
do not require a change to the current regulations because the
provisions are consistent with existing CMS policy, we are
discretionarily proposing to amend the regulations text at 42 CFR
424.22(c) to align the regulations text with current sub-regulatory
guidance to allow medical record documentation from the HHA to be used
to support the basis for certification and/or recertification of
[[Page 32424]]
home health eligibility, if the following requirements are met:
The documentation from the HHA can be corroborated by
other medical record entries in the certifying physician's and/or the
acute/post-acute care facility's medical record for the patient,
thereby creating a clinically consistent picture that the patient is
eligible for Medicare home health services as specified in Sec. 424.22
(a)(1) and (b).
The certifying physician signs and dates the HHA
documentation demonstrating that the documentation from the HHA was
considered when certifying patient eligibility for Medicare home health
services. HHA documentation can include, but is not limited to, the
patient's plan of care required in accordance with 42 CFR 409.43 and
the initial and/or comprehensive assessment of the patient required in
accordance with 42 CFR 484.55.
We believe that this proposal incorporates existing sub-regulatory
flexibilities into the regulations text that allow HHA medical record
documentation to support the basis of home health eligibility. By
incorporating the existing sub-regulatory guidance into regulation,
HHAs are assured that HHA-generated documentation can be used as
supporting material for the basis of home health eligibility, as long
as all conditions are met, as described previously. HHAs have the
discretion to determine the type and format of any documentation used
to support home health eligibility. The expectation is that the HHA-
generated supporting medical record documentation would be used to
support the existing medical record of the certifying physician or the
acute/post-acute care facility to create a clinically consistent
picture that the individual is confined to the home and requires
skilled services. Anecdotally, we have received reports from HHAs that
they typically include this supporting information on the plan of care.
Generally, the certifying physician is also the physician who
establishes the plan of care and the plan of care must be signed by the
physician. Consequently, no additional burden is incurred by either the
HHA or the certifying physician. As existing sub-regulatory guidance
allows HHA-generated documentation to be used as supporting material
for the physician's determination of eligibility for home health
services, we expect that most HHAs already have a process in place to
provide this information to the certifying physician or the acute/post-
acute care facility. We welcome comments on this assumption.
We invite comments on this proposal to amend the regulations text
at Sec. 424.22(c), which would codify subregulatory guidance allowing
HHA-generated medical record documentation to be used as supporting
material to the certifying physician's or the acute and/or post-acute
care facility's medical record documentation as part of the
certification and/or recertification of eligibility for home health
services, under certain circumstances. The corresponding proposed
regulations text changes can be found in section VIII. of this proposed
rule.
4. Proposed Elimination of Recertification Requirement To Estimate How
Much Longer Home Health Services Will Be Required
In the CY 2018 HH PPS proposed rule (82 FR 35378), we invited
public comments about improvements that can be made to the health care
delivery system that reduce unnecessary burdens for clinicians, other
providers, and patients and their families. Specifically, we asked the
public to submit their ideas for regulatory, sub-regulatory, policy,
practice, and procedural changes to reduce burdens for hospitals,
physicians, and patients, improve the quality of care, decrease costs,
and ensure that patients and their providers and physicians are making
the best health care choices possible. We specifically stated that CMS
would not respond to the comment submissions in the final rule.
Instead, we would review the comments submitted in response to the
requests for information and actively consider them as we develop
future regulatory proposals or future sub-regulatory policy guidance.
Several commenters requested that CMS consider eliminating the
requirement that the certifying physician include an estimate of how
much longer skilled services will be required at each home health
recertification, as set forth at Sec. 424.22(b)(2) and in sub-
regulatory guidance in the Medicare Benefit Policy Manual (Chapter 7,
Section 30.5.2). Commenters stated that this estimate is duplicative of
the Home Health Conditions of Participation (CoP) requirements for the
content of the home health plan of care, set out at 42 CFR
484.60(a)(2).
The Home Health CoP at Sec. 484.60(a)(2) sets forth the
requirements for the content of the home health plan of care, which
includes the types of services, supplies, and equipment required, as
well as, the frequency and duration of visits to be made. Commenters
stated that the plan of care requirement already includes the frequency
and duration of visits to be made and is an estimate of how much longer
home health services are expected to be required by the patient. They
observed that including this information as part of the recertification
statement is duplicative and unnecessary. Commenters went on to say
that because the certifying physician must review, sign and date the
plan of care at least every 60-days, he/she is attesting to how much
longer he/she thinks the patient will require home health services.
Commenters also stated that this estimate appears to have no value to
the patient, the physician, the HHA, or to CMS, but failure to include
the physician's estimate of how much longer skilled care will be
required can result in claim denials.
We have determined that the estimate of how much longer skilled
care will be required at each recertification is not currently used for
quality, payment, or program integrity purposes. Given this
consideration and the Home Health CoP requirements for the content of
the home health plan of care, and to mitigate any potential denials of
home health claims that otherwise would meet all other Medicare
requirements, we are proposing to eliminate the regulatory requirement
as set forth at 42 CFR 424.22(b)(2), that the certifying physician, as
part of the recertification process, provide an estimate of how much
longer skilled services will be required. All other recertification
content requirements under Sec. 424.22(b)(2) would remain unchanged.
We believe the elimination of this recertification requirement would
result in a reduction of burden for certifying physicians by reducing
the amount of time physicians spend on the recertification process and
would result in an overall cost savings of $14.2 million. We provided a
more detailed description of this burden reduction in section
VIII.C.1.c. of this proposed rule.
We invite comments regarding the proposed elimination of the
requirement that the certifying physician include an estimate of how
much longer skilled services will be required at each home health
recertification, as well as the corresponding regulations text changes
at Sec. 424.22(b)(2).
While we are not proposing any additional changes to the home
health payment regulations in this proposed rule as suggested by
commenters in the RFI, we will continue to consider whether future
regulatory or sub-regulatory changes are warranted to reduce
unnecessary burden. We thank
[[Page 32425]]
the commenters for taking the time to convey their thoughts and
suggestions on this initiative.
H. Proposed Change Regarding Remote Patient Monitoring Under the
Medicare Home Health Benefit
Section 4012 of the 21st Century Cures Act directed the Centers for
Medicare & Medicaid Services (CMS) to provide information on the
current use of and/or barriers to telehealth services. This directive,
along with advancements in technology, prompted us to examine ways in
which HHAs can integrate telehealth and/or remote patient monitoring
into the care planning process. Telehealth services, under section
1834(m)(4) of the Act, include services such as professional
consultations, office visits, pharmacologic management, and office
psychiatry services furnished via a telecommunications system by a
distant site physician or practitioner to a patient located at a
designated ``originating site.'' Originating sites, as defined under
section 1834(m)(4)(C) of the Act, generally must be certain kinds of
healthcare settings located in certain geographic areas. This
definition generally does not include the beneficiary's home. As a
Medicare condition for payment, an interactive telecommunications
system generally is required when furnishing telehealth services.
Medicare defines ``interactive telecommunication systems'' as audio and
video equipment permitting two-way, real-time interactive communication
between the patient and distant site physician or practitioner (42 CFR
410.78). Telehealth services are used to substitute for professional
in-person visits when certain eligibility criteria are met. For
patients receiving care under the Medicare home health benefit, section
1895(e)(1)(A) of the Act prohibits payment for services furnished via a
telecommunications system if such services substitute for in-person
home health services ordered as part of a plan of care certified by a
physician. However, the statute does not define the term
``telecommunications system'' as it relates to the provision of home
health care and explicitly notes that an HHA is not prevented from
providing services via a telecommunications system, assuming the
service is not considered a home health visit for purposes of
eligibility or payment.
Remote patient monitoring, while a service using a form of
telecommunications, is not considered a Medicare telehealth service as
defined under section 1834(m) of the Act, but rather uses ``digital
technologies to collect medical and other forms of health data from
individuals in one location and electronically transmit that
information securely to health care providers in a different location
for assessment and recommendations.'' \52\ For example, remote patient
monitoring allows the patient to collect and transmit his or her own
clinical data, such as weight, blood pressure, and heart rate for
monitoring and analysis. The clinical data is monitored without a
direct interaction between the practitioner and beneficiary, and then
reviewed by the HHA for potential consultation with the certifying
physician for changes in the plan of care. Additionally, because remote
patient monitoring is not statutorily considered a telehealth service,
it would not be subject to the restrictions on originating site and
interactive telecommunications systems technology.
---------------------------------------------------------------------------
\52\ http://www.cchpca.org/remote-patient-monitoring.
---------------------------------------------------------------------------
We believe remote patient monitoring could be beneficial in
augmenting the home health services outlined in the patient's plan of
care, without replicating or replacing home health visits. The plan of
care, in accordance with the home health conditions of participation
(CoPs), must identify patient-specific measurable outcomes and goals,
and be established, periodically reviewed, and signed by a physician
(42 CFR 484.60(a)). The HHA must also promptly alert the relevant
physician(s) to any changes in the patient's condition or needs that
suggest that outcomes are not being achieved, or that the plan of care
must be altered (42 CFR 484.60(c)). Remote patient monitoring could
enable the HHA to more quickly identify any changes in the patient's
clinical condition, as well as monitor patient compliance, prompting
physician review of, and potential changes to, the plan of care, as
required per the CoPs. Particularly in cases where the home health
patient is admitted for skilled observation and assessment of the
patient's condition due to a reasonable potential for complications or
an acute episode, remote patient monitoring could augment home health
visits until the patient's clinical condition stabilized. Fluctuating
or abnormal vital signs could be monitored between visits, potentially
leading to quicker interventions and updates to the treatment plan.
A review of the literature shows that utilizing remote patient
monitoring in chronic disease management has the potential to
``significantly improve an individual's quality of life, allowing
patients to maintain independence, prevent complications, and minimize
costs.'' \53\ Specifically for patients with chronic obstructive
pulmonary disease (COPD) and congestive heart failure (CHF), research
indicates that remote patient monitoring has been successful in
reducing readmissions and long-term acute care utilization.\54\
Likewise, a systematic review of evidence collected by the Agency for
Healthcare Research and Quality (AHRQ) revealed that remote patient
monitoring of chronic cardiac and respiratory conditions resulted in
lower mortality, improved quality of life, and reductions in hospital
admissions.\55\ If changes in condition are identified early through
careful monitoring, serious complications may be avoided, potentially
preventing emergency department visits and hospital admissions.
Surveillance and case management are frequently occurring interventions
in home health, and remote patient monitoring leverages technology to
encourage patient involvement and accountability in order to improve
care coordination.
---------------------------------------------------------------------------
\53\ Rojhan, K., Laplante, S., Sloand, J., Main, C., Ibrahim,
A., Wild, J., Sturt, N. Remote Monitoring of Chronic Diseases: A
Landscape Assessment of Policies in Four European Countries (2016)
PLOS One. V11 (5) https://dx.doi.org/10.1371%2Fjournal.pone.0155738.
\54\ Broad, J., Davis, C., Bender, M., Smith, T. (2014)
Feasibility and Acute Care Utilization Outcomes of a Post-Acute
Transitional Telemonitoring Program for Underserved Chronic Disease
Patients. Journal of Cardiac Failure. Vol 20 (8S) S116. http://dx.doi.org/10.1016/j.cardfail.2014.06.328.
\55\ Department of Health and Human Services, Agency for
Healthcare Research and Quality, Telehealth: Mapping the Evidence
for Patient Outcomes from Systematic Reviews, Technical Brief Number
26 (Washington, DC: June 2016).
---------------------------------------------------------------------------
Anecdotally, we have heard from various home health agencies
regarding integration of remote patient monitoring into the care
planning process. For example, on a recent site visit to a home health
agency, CMS participated in a care coordination meeting, which included
a discussion of the agency's experience implementing remote patient
monitoring in home health episodes. Certain patients with chronic
conditions received tablets pre-loaded with software enabling patients
to take and transmit their vital signs on a daily basis. The
transmitted health data was then monitored and analyzed by an outside
service, which contacted the HHA with any changes or abnormalities.
This example highlights how remote patient monitoring could be
integrated into the home health episode of care.
Additionally, we believe that the growth of technology and new
software development could be used in the
[[Page 32426]]
provision of care and care coordination in the home, as well as empower
patients to be active participants in their disease management. Other
than the statutory requirement that services furnished via a
telecommunications system may not substitute for in-person home health
services ordered as part of a plan of care certified by a physician, we
do not have specific policies surrounding the use of remote patient
monitoring by HHAs. We anticipate that HHAs would follow clinical and
manufacturer guidelines when implementing the technology into clinical
practice, while still meeting all statutory requirements, conditions
for payment, and the home health conditions of participation.
Medicare began making separate payment in CY 2018 for CPT code
99091 that allows physicians and other healthcare professionals to bill
for the collection and interpretation of physiologic data digitally
stored and/or transmitted by the patient and/or caregiver to the
physician or other qualified health care professional (82 CFR 53013).
CPT code 99091 is paid under the Medicare physician fee schedule, and
thus cannot be billed by HHAs. Additionally, it includes the
interpretation of the physiologic data, whereas the HHA would only be
responsible for the collection of the data. However, with this
distinction, we feel the code's description accurately describes remote
monitoring services. Therefore, we propose to define remote patient
monitoring under the Medicare home health benefit as ``the collection
of physiologic data (for example, ECG, blood pressure, glucose
monitoring) digitally stored and/or transmitted by the patient and/or
caregiver to the HHA.''
Although the cost of remote patient monitoring is not separately
billable under the HH PPS and may not be used as a substitute for in-
person home health services, there is nothing to preclude HHAs from
using remote patient monitoring to augment the care planning process as
appropriate. As such, we believe the expenses of remote patient
monitoring, if used by the HHA to augment the care planning process,
must be reported on the cost report as allowable administrative costs
(that is, operating expenses) that are factored into the costs per
visit. Currently, costs associated with remote patient monitoring are
reported on line 23.20 on Worksheet A, as direct costs associated with
telemedicine. For 2016, approximately 3 percent of HHAs reported
telemedicine costs that accounted for roughly 1 percent of their total
agency costs on the HHA cost report. However, these costs are not
allocated to the costs per visit. We propose to amend the regulations
at 42 CFR 409.46 to include the costs of remote patient monitoring as
an allowable administrative cost (that is, operating expense), if
remote patient monitoring is used by the HHA to augment the care
planning process. This would allow HHAs to report the costs of remote
patient monitoring on the HHA cost report as part of their operating
expenses. These costs would then be factored into the costs per visit.
Factoring the costs associated with remote patient monitoring into the
costs per visit has important implications for assessing home health
costs relevant to payment, including HHA Medicare margin calculations.
We are soliciting comments on the proposed definition of remote patient
monitoring under the HH PPS to describe telecommunication services used
to augment the plan of care during a home health episode. Additionally,
we welcome comments regarding additional utilization of
telecommunications technologies for consideration in future rulemaking.
We are also soliciting comments on the proposed changes to the
regulations at 42 CFR 409.46, to include the costs of remote patient
monitoring as allowable administrative costs (that is, operating
expenses), as detailed in section IX. of this proposed rule.
IV. Home Health Value-Based Purchasing (HHVBP) Model
A. Background
As authorized by section 1115A of the Act and finalized in the CY
2016 HH PPS final rule (80 FR 68624), we began testing the HHVBP Model
on January 1, 2016. The HHVBP Model has an overall purpose of improving
the quality and delivery of home health care services to Medicare
beneficiaries. The specific goals of the Model are to: (1) Provide
incentives for better quality care with greater efficiency; (2) study
new potential quality and efficiency measures for appropriateness in
the home health setting; and (3) enhance the current public reporting
process.
Using the randomized selection methodology finalized in the CY 2016
HH PPS final rule, we selected nine states for inclusion in the HHVBP
Model, representing each geographic area across the nation. All
Medicare-certified Home Health Agencies (HHAs) providing services in
Arizona, Florida, Iowa, Maryland, Massachusetts, Nebraska, North
Carolina, Tennessee, and Washington (competing HHAs) are required to
compete in the Model. Requiring all Medicare-certified HHAs providing
services in the selected states to participate in the Model ensures
that: (1) There is no selection bias; (2) participating HHAs are
representative of HHAs nationally; and, (3) there is sufficient
participation to generate meaningful results.
As finalized in the CY 2016 HH PPS final rule, the HHVBP Model uses
the waiver authority under section 1115A(d)(1) of the Act to adjust
Medicare payment rates under section 1895(b) of the Act beginning in CY
2018 based on the competing HHAs' performance on applicable measures.
Payment adjustments will be increased incrementally over the course of
the HHVBP Model in the following manner: (1) A maximum payment
adjustment of 3 percent (upward or downward) in CY 2018; (2) a maximum
payment adjustment of 5 percent (upward or downward) in CY 2019; (3) a
maximum payment adjustment of 6 percent (upward or downward) in CY
2020; (4) a maximum payment adjustment of 7 percent (upward or
downward) in CY 2021; and (5) a maximum payment adjustment of 8 percent
(upward or downward) in CY 2022. Payment adjustments are based on each
HHA's Total Performance Score (TPS) in a given performance year (PY)
comprised of: (1) A set of measures already reported via the Outcome
and Assessment Information Set (OASIS) and completed Home Health
Consumer Assessment of Healthcare Providers and Systems (HHCAHPS)
surveys for all patients serviced by the HHA and select claims data
elements; and (2) three New Measures for which points are achieved for
reporting data.
For CY 2019, we are proposing to remove five measures and add two
new proposed composite measures to the applicable measure set for the
HHVBP model, revise our weighting methodology for the measures, and
rescore the maximum number of improvement points.
B. Quality Measures
1. Proposal To Remove Two OASIS-Based Measures Beginning With
Performance Year 4 (CY 2019)
In the CY 2016 HH PPS final rule, we finalized a set of quality
measures in Figure 4a: Final PY1 Measures and Figure 4b: Final PY1 New
Measures (80 FR 68671 through 68673) for the HHVBP Model used in PY1,
referred to as the starter set. We also stated that this set of
measures will be subject to change or retirement during subsequent
model years and revised through the rulemaking process (80 FR 68669).
[[Page 32427]]
The measures were selected for the Model using the following
guiding principles: (1) Use a broad measure set that captures the
complexity of the services HHAs provide; (2) incorporate flexibility
for future inclusion of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT) measures that cut across post-acute
care settings; (3) develop `second generation' (of the HHVBP Model)
measures of patient outcomes, health and functional status, shared
decision making, and patient activation; (4) include a balance of
process, outcome and patient experience measures; (5) advance the
ability to measure cost and value; (6) add measures for appropriateness
or overuse; and (7) promote infrastructure investments. This set of
quality measures encompasses the multiple National Quality Strategy
(NQS) domains \56\ (80 FR 68668). The NQS domains include six priority
areas identified in the CY 2016 HH PPS final rule (80 FR 68668) as the
CMS Framework for Quality Measurement Mapping. These areas are: (1)
Clinical quality of care; (2) Care coordination; (3) Population &
community health; (4) Person- and Caregiver-centered experience and
outcomes; (5) Safety; and (6) Efficiency and cost reduction. Figures 4a
and 4b of the CY 2016 HH PPS final rule identified 15 outcome measures
(five from the HHCAHPS, eight from OASIS, and two claims-based
measures), and nine process measures (six from OASIS, and three New
Measures, which were not previously reported in the home health
setting) for use in the Model.
---------------------------------------------------------------------------
\56\ 2015 Annual Report to Congress, http://www.ahrq.gov/workingforquality/reports/annual-reports/nqs2015annlrpt.htm.
---------------------------------------------------------------------------
In the CY 2017 HH PPS final rule, we removed four measures from the
measure set for PY1 and subsequent performance years: (1) Care
Management: Types and Sources of Assistance; (2) Prior Functioning ADL/
IADL; (3) Influenza Vaccine Data Collection Period: Does this episode
of care include any dates on or between October 1 and March 31?; and
(4) Reason Pneumococcal Vaccine Not Received, for the reasons discussed
in that final rule (81 FR 76743 through 76747).
In the CY 2018 HH PPS final rule, we removed the Drug Education on
All Medications Provided to Patient/Caregiver during All Episodes of
Care from the set of applicable measures beginning with PY3 for the
reasons discussed in that final rule (82 FR 51703 through 51704).
For PY4 and subsequent performance years, we propose to remove two
OASIS-based process measures, Influenza Immunization Received for
Current Flu Season and Pneumococcal Polysaccharide Vaccine Ever
Received, from the set of applicable measures. We adopted the Influenza
Immunization Received for Current Flu Season measure beginning PY1 of
the model. Since that time, we have received input from both
stakeholders and a Technical Expert Panel (TEP) convened by our
contractor in 2017 that because the measure does not exclude HHA
patients who were offered the vaccine but declined it and patients who
were ineligible to receive it due to contraindications, the measure may
not fully capture HHA performance in the administration of the
influenza vaccine. In response to these concerns, we are proposing to
remove the measure from the applicable measure set beginning PY4.
We also adopted the Pneumococcal Polysaccharide Vaccine Ever
Received measure beginning PY1 of the model. This process measure
reports the percentage of HH episodes during which patients were
determined to have ever received the Pneumococcal Polysaccharide
Vaccine. The measure is based on guidelines previously issued by the
Advisory Committee on Immunization Practices (ACIP),\57\ which
recommended use of a single dose of the 23-valent pneumococcal
polysaccharide vaccine (PPSV23) among all adults aged 65 years and
older and those adults aged 19-64 years with underlying medical
conditions that put them at greater risk for serious pneumococcal
infection.\58\ In 2014, the ACIP updated its guidelines to recommend
that both PCV13 and PPSV23 be given to all immunocompetent adults aged
>=65 years.\59\ The recommended intervals for sequential administration
of PCV13 and PPSV23 depend on several patient factors including: The
current age of the adult, whether the adult had previously received
PPSV23, and the age of the adult at the time of prior PPSV23
vaccination (if applicable). Because the Pneumococcal Polysaccharide
Vaccine Ever Received measure does not fully reflect the current ACIP
guidelines, we are proposing to remove this measure from the model
beginning PY4.
---------------------------------------------------------------------------
\57\ The Advisory Committee on Immunization Practices was
established under Section 222 of the Public Health Service Act (42
U.S.C. 217a), as amended, to assist states and their political
subdivisions in the prevention and control of communicable diseases;
to advise the states on matters relating to the preservation and
improvement of the public's health; and to make grants to states
and, in consultation with the state health authorities, to agencies
and political subdivisions of states to assist in meeting the costs
of communicable disease control programs. (Charter of the Advisory
Committee on Immunization Practices, filed April 1, 2018. https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf).
\58\ Prevention of Pneumococcal Disease: Recommendations of the
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
\59\ Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent
pneumococcal conjugate vaccine and 23-valent pneumococcal
polysaccharide vaccine among adults aged >=65 years: Recommendations
of the Advisory Committee on Immunization Practices (ACIP). MMWR
2014; 63: 822-5.
---------------------------------------------------------------------------
2. Proposal To Replace Three OASIS-Based Measures With Two Composite
Measures Beginning With Performance Year 4
As previously noted, one of the goals of the HHVBP Model is to
study new potential quality and efficiency measures for appropriateness
in the home health setting. In the CY 2018 HH PPS Final Rule, we
solicited comment on additional quality measures for future
consideration in the HHVBP model, specifically a Total Change in ADL/
IADL Peformance by HHA Patients Measure, a Composite Functional Decline
Measure, and behavioral health measures (82 FR 51706 through 51711).
For the reasons discussed, we are proposing to replace three individual
OASIS measures (Improvement in Bathing, Improvement in Bed
Transferring, and Improvement in Ambulation-Locomotion) with two
composite measures: Total Normalized Composite Change in Self-Care and
Total Normalized Composite Change in Mobility. These proposed measures
use several of the same ADLs as the composite measures discussed in the
CY 2018 HH PPS Final Rule (82 FR 51707). Our contractor convened a TEP
in November 2017, which supported the use of two proposed composite
measures in place of the three individual measures because HHA
performance on the three individual measures would be combined with HHA
performance on six additional ADL measures to create a more
comprehensive assessment of HHA performance across a broader range of
patient ADL outcomes. The TEP also noted that HHA performance is
currently measured based on any change in improvement in patient
status, while the composite measures would report the magnitude of
patient change (either improvement or decline) across six self-care and
three mobility patient outcomes.
There are currently three ADL improvement measures in the HHVBP
Model (Improvement in Bathing,
[[Page 32428]]
Improvement in Bed Transferring, and Improvement in Ambulation-
Locomotion). The maximum cumulative score across all three measures is
30. Because we are proposing to replace these three measures with the
two composite measures, we are also proposing that each of the two
composite measures would have a maximum score of 15 points, to ensure
that the relative weighting of ADL-based measures would stay the same
if the proposal to replace the three ADL improvement measures with the
two composite measures is adopted. That is, there would still be a
maximum of 30 points available for ADL related measures.
The proposed Total Normalized Composite Change in Self-Care and
Total Normalized Composite Change in Mobility measures would represent
a new direction in how quality of patient care is measured in home
health. Both of these proposed composite measures combine several
existing and endorsed Home Health Quality Reporting Program (HH QRP)
outcome measures into focused composite measures to enhance quality
reporting. These proposed composite measures fit within the Patient and
Family Engagement \60\ domain as functional status and functional
decline are important to assess for residents in home health settings.
Patients who receive care from an HHA may have functional limitations
and may be at risk for further decline in function because of limited
mobility and ambulation.
---------------------------------------------------------------------------
\60\ 2017 Measures under Consideration List. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/2017-CMS-Measurement-Priorities-and-Needs.pdf.
---------------------------------------------------------------------------
The proposed Total Normalized Composite Change in Self-Care measure
computes the magnitude of change, either positive or negative, based on
a normalized amount of possible change on each of six OASIS-based
quality outcomes. These six outcomes are as follows:
Improvement in Grooming (M1800)
Improvement in Upper Body Dressing (M1810)
Improvement in Lower Body Dressing (M1820)
Improvement in Bathing (M1830)
Improvement in Toileting Hygiene (M1845)
Improvement in Eating (M1870)
The proposed Total Normalized Composite Change in Mobility measure
computes the magnitude of change, either positive or negative, based on
the normalized amount of possible change on each of three OASIS-based
quality outcomes. These three outcomes are as follows:
Improvement in Toilet Transferring (M1840)
Improvement in Bed Transferring (M1850)
Improvement in Ambulation/Locomotion (M1860)
The magnitude of possible change for these OASIS items varies based
on the number of response options. For example, M1800 (grooming) has
four behaviorally-benchmarked response options (0 = most independent; 3
= least independent) while M1830 (bathing) has seven behaviorally-
benchmarked response options (0 = most independent; 6 = least
independent). The maximum possible change for a patient on item M1800
is 3, while the maximum possible change for a patient on item M1830 is
6. Both proposed composite measures would be computed and normalized at
the episode level, then aggregated to the HHA level using the following
steps:
Step 1: Calculate absolute change score for each OASIS
item (based on change between Start of Care(SOC)/Resumption of Care
(ROC) and discharge) used to compute the Total Normalized Composite
Change in Self-Care (6 items) or Total Normalized Composite Change in
Mobility (3 items) measures.
Step 2: Normalize scores based on maximum change possible
for each OASIS item (which varies across different items). The
normalized scores result in a maximum possible change for any single
item equal to ``1''; this score is provided when a patient achieves the
maximum possible change for the OASIS item.
Step 3: Total score for Total Normalized Composite Change
in Self-Care or Total Normalized Composite Change in Mobility is
calculated by summing the normalized scores for the items in the
measure. Hence, the maximum possible range of normalized scores at the
patient level for Total Normalized Composite Change in Self-Care is -6
to +6, and for Total Normalized Composite Change in Mobility is -3 to
+3.
We created two prediction models for the proposed Total Normalized
Composite Change in Self-Care (TNC_SC) and Total Normalized Composite
Change in Mobility (TNC_MOB) measures using information from OASIS
items and patient clinical condition categories (see Table 50 for
details on the number of OASIS items and OASIS clinical categories used
in the prediction models). We computed multiple ordinary least squares
(OLS) analyses beginning with risk factors that were available from
OASIS D items and patient condition groupings. Any single OASIS D item
might have more than one risk factor because we create dichotomous risk
factors for each response option on scaled (from dependence to
independence) OASIS items. Those risk factors that were statistically
significant at p <0.0001 level were kept in the prediction model. These
two versions (CY 2014 and CY 2015) of the prediction models were done
as ``proof of concept.'' We are proposing that the actual prediction
models that would be used if the proposed composite measures are
finalized would use episodes of care that ended in CY 2017, which would
be the baseline year for the quality outcome measures used to compute
the two proposed composite measures, as listed previously. The baseline
year for these two composite measures would be calendar year 2017.
The following Table 50 provides an overview of results from the CY
2014 and CY 2015 prediction models for each proposed measure with
estimated R-squared values comparing observed vs. predicted episode-
level performance.
Table 50--Observed Versus Predicted Episode-Level Peformance for the Proposed Total Normalized Composite Change
Measures
----------------------------------------------------------------------------------------------------------------
Number of Number of
Prediction model for OASIS items clinical R[dash]squared
used categories value
----------------------------------------------------------------------------------------------------------------
2014 TNC_SC..................................................... 42 14 0.299
2015 TNC_SC..................................................... 41 13 0.311
2014 TNC_MOB.................................................... 42 16 0.289
[[Page 32429]]
2015 TNC_MOB.................................................... 41 18 0.288
----------------------------------------------------------------------------------------------------------------
Table 50 presents the following summary information for the
prediction models for the two proposed composite measures.
Prediction Model for: This column identifies the measure
and year of data used for the two ``proof of concept'' prediction
models created for each of the two proposed composite measures, Total
Normalized Composite Change in Self-Care (TNC_SC) and Total Normalized
Composite Change in Mobility (TNC_MOB). The development of the
prediction models was identical in terms of the list of potential risk
factors and clinical categories. The only difference was one set of
prediction models used episodes of care that ended in CY 2014, while
the other set of prediction models used episodes of care that ended in
CY 2015.
Number of OASIS Items Used: This column indicates the
number of OASIS items used as risk factors in the prediction model. For
each prediction model, the number of OASIS items used is based on the
number of risk factors that were statistically significant at p <0.0001
level in the prediction model.
Number of Clinical Categories: This column indicates the
number of patient clinical categories (for example, diagnoses related
to infections or neoplasms or endocrine disorders) that are used as
risk factors in the prediction model.
R-squared Value: The R-squared values are a measure of the
proportion of the variation in outcomes that is accounted for by the
prediction model. The results show that the methodology that was used
to create the prediction models produced very consistent models that
predict at least 29 percent of the variability in the proposed
composite measures.
The prediction models are applied at the episode level to create a
specific predicted value for the composite measure for each episode of
care. These episode level predicted values are averaged to compute a
national predicted value and an HHA predicted value. The episode level
observed values are averaged to compute the HHA observed value. The HHA
TNC_SC and TNC_MOB observed scores are risk adjusted based on the
following formula:
HHA Risk Adjusted = HHA Observed + National Predicted-HHA Predicted
HHAs are not allowed to skip any of the OASIS items that are used
to compute these proposed composite measures or the risk factors that
comprise the prediction models for the two proposed composite measures.
The OASIS items typically do not include ``not available (NA)'' or
``unknown (UK)'' response options, and per HHQRP requirements,\61\ HHAs
must provide responses to all OASIS items for the OASIS assessment to
be accepted into the CMS data repository. Therefore, while we believe
the likelihood that a value for one of these items would be missing is
extremely small, we are proposing to impute a value of ``0'' if a value
is ``missing.'' Specifically, if for some reason the information on one
or more OASIS items that are used to compute TNC_SC or TNC_MOB is
missing, we impute the value of ``0'' (no change) for the missing
value. Similarly, if for some reason the information on one or more
OASIS items that are used as a risk factor is missing, we impute the
value of ``0'' (no effect) for missing values that comprise the
prediction models for the two proposed composite measures. Table 51
contains summary information for these two proposed composite measures.
Because the proposed TNC_SC and TNC_MOB are composite measures rather
than simple outcome measures, the terms ``Numerator'' and
``Denominator'' do not apply to how these measures are calculated.
Therefore, for these proposed composite measures, the ``Numerator'' and
``Denominator'' columns in Table 51 are replaced with columns
describing ``Measure Computation'' and ``Risk Adjustment''.
---------------------------------------------------------------------------
\61\ Data Specifications--https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/OASIS/DataSpecifications.html.
---------------------------------------------------------------------------
Table 51 contains the set of applicable measures under the HHVBP
model, if we finalize our proposals to remove the OASIS-based measures,
Influenza Immunization Received for Current Flu Season, Pneumococcal
Polysaccharide Vaccine Ever Received, Improvement in Ambulation-
Locomotion, Improvement in Bed Transferring, and Improvement in
Bathing, and add the two proposed OASIS-based outcome composite
measures, Total Change in Self-Care and Total Change in Mobility. This
measure set, if our proposals are finalized, would be applicable to PY4
and each subsequent performance year until such time that another set
of applicable measures, or changes to this measure set, are proposed
and finalized in future rulemaking.
Table 51--Measure Set for the HHVBP Model Beginning PY 4 *
--------------------------------------------------------------------------------------------------------------------------------------------------------
NQS domains Measure title Measure type Identifier Data source Numerator Denominator
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Quality of Care........ Improvement in Outcome........... NA................ OASIS (M1400)..... Number of home Number of home
Dyspnea. health episodes health episodes
of care where the of care ending
discharge with a discharge
assessment during the
indicates less reporting period,
dyspnea at other than those
discharge than at covered by
start (or generic or
resumption) of measure-specific
care. exclusions.
Communication & Care Discharged to Outcome........... NA................ OASIS (M2420)..... Number of home Number of home
Coordination. Community. health episodes health episodes
where the of care ending
assessment with discharge or
completed at the transfer to
discharge inpatient
indicates the facility during
patient remained the reporting
in the community period, other
after discharge. than those
covered by
generic or
measure-specific
exclusions.
[[Page 32430]]
Efficiency & Cost Reduction..... Acute Care Outcome........... NQF0171........... CCW (Claims)...... Number of home Number of home
Hospitalization: health stays for health stays that
Unplanned patients who have begin during the
Hospitalization a Medicare claim 12-month
during first 60 for an unplanned observation
days of Home admission to an period. A home
Health. acute care health stay is a
hospital in the sequence of home
60 days following health payment
the start of the episodes
home health stay. separated from
other home health
payment episodes
by at least 60
days.
Efficiency & Cost Reduction..... Emergency Outcome........... NQF0173........... CCW (Claims)...... Number of home Number of home
Department Use health stays for health stays that
without patients who have begin during the
Hospitalization. a Medicare claim 12-month
for outpatient observation
emergency period. A home
department use health stay is a
and no claims for sequence of home
acute care health payment
hospitalization episodes
in the 60 days separated from
following the other home health
start of the home payment episodes
health stay. by at least 60
days.
Patient Safety.................. Improvement in Outcome........... NQF0177........... OASIS (M1242)..... Number of home Number of home
Pain Interfering health episodes health episodes
with Activity. of care where the of care ending
value recorded on with a discharge
the discharge during the
assessment reporting period,
indicates less other than those
frequent pain at covered by
discharge than at generic or
the start (or measure-specific
resumption) of exclusions.
care.
Patient Safety.................. Improvement in Outcome........... NQF0176........... OASIS (M2020)..... Number of home Number of home
Management of health episodes health episodes
Oral Medications. of care where the of care ending
value recorded on with a discharge
the discharge during the
assessment reporting period,
indicates less other than those
impairment in covered by
taking oral generic or
medications measure-specific
correctly at exclusions.
discharge than at
start (or
resumption) of
care.
Patient & Caregiver-Centered Care of Patients.. Outcome........... .................. CAHPS............. NA................ NA.
Experience.
Patient & Caregiver-Centered Communications Outcome........... .................. CAHPS............. NA................ NA.
Experience. between Providers
and Patients.
Patient & Caregiver-Centered Specific Care Outcome........... .................. CAHPS............. NA................ NA.
Experience. Issues.
Patient & Caregiver-Centered Overall rating of Outcome........... .................. CAHPS............. NA................ NA.
Experience. home health care.
Patient & Caregiver-Centered Willingness to Outcome........... .................. CAHPS............. NA................ NA.
Experience. recommend the
agency.
Population/Community Health..... Influenza Process........... NQF0431 (Used in Reported by HHAs Healthcare Number of
Vaccination other care through Web personnel in the healthcare
Coverage for Home settings, not Portal. denominator personnel who are
Health Care Home Health). population who working in the
Personnel. during the time healthcare
from October 1 facility for at
(or when the least 1 working
vaccine became day between
available) October 1 and
through March 31 March 31 of the
of the following following year,
year: (a) regardless of
Received an clinical
influenza responsibility or
vaccination patient contact.
administered at
the healthcare
facility, or
reported in
writing or
provided
documentation
that influenza
vaccination was
received
elsewhere: Or (b)
were determined
to have a medical
contraindication/
condition of
severe allergic
reaction to eggs
or to other
components of the
vaccine or
history of
Guillain-Barre
Syndrome within 6
weeks after a
previous
influenza
vaccination; or
(c) declined
influenza
vaccination; or
(d) persons with
unknown
vaccination
status or who do
not otherwise
meet any of the
definitions of
the previously
mentioned
numerator
categories.
Population/Community Health..... Herpes zoster Process........... NA................ Reported by HHAs Total number of Total number of
(Shingles) through Web Medicare Medicare
vaccination: Has Portal. beneficiaries beneficiaries
the patient ever aged 60 years and aged 60 years and
received the over who report over receiving
shingles having ever services from the
vaccination?. received zoster HHA.
vaccine (shingles
vaccine).
[[Page 32431]]
Communication & Care Advance Care Plan. Process........... NQF0326........... Reported by HHAs Patients who have All patients aged
Coordination. through Web an advance care 65 years and
Portal. plan or surrogate older.
decision maker
documented in the
medical record or
documentation in
the medical
record that an
advanced care
plan was
discussed but the
patient did not
wish or was not
able to name a
surrogate
decision maker or
provide an
advance care plan.
--------------------------------------------------------------------------------------------------------------------------------------------------------
NQS domains Measure title Measure type Identifier Data source Measure Risk adjustment **
computation **
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient and Family Engagement... Total Normalized Composite Outcome. NA................ OASIS (M1800) The total A prediction model
Composite Change (M1810) (M1820) normalized change is computed at
in Self-Care. (M1830) (M1845) in self-care the episode
(M1870). functioning level. The
across six OASIS predicted value
items (grooming, for the HHA and
bathing, upper & the national
lower body value of the
dressing, toilet predicted values
hygiene, and are calculated
eating). and are used to
calculate the
risk-adjusted
rate for the HHA,
which is
calculated using
this formula: HHA
Risk Adjusted =
HHA Observed +
National
Predicted - HHA
Predicted.
Patient and Family Engagement... Total Normalized Composite Outcome. NA................ OASIS (M1840) The total A prediction model
Composite Change (M1850) (M1860). normalized change is computed at
in Mobility. in mobility the episode
functioning level. The
across three predicted value
OASIS items for the HHA and
(toilet the national
transferring, bed value of the
transferring, and predicted values
ambulation/ are calculated
locomotion). and are used to
calculate the
risk-adjusted
rate for the HHA,
which is
calculated using
this formula: HHA
Risk Adjusted =
HHA Observed +
National
Predicted - HHA
Predicted.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Notes: For more detailed information on the measures using OASIS refer to the OASIS-C2 Guidance Manual effective January 1, 2017 available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/OASIS-C2-Guidance-Manual-6-29-16.pdf.
For NQF endorsed measures see The NQF Quality Positioning System available at http://www.qualityforum.org/QPS. For non-NQF measures using OASIS see
links for data tables related to OASIS measures at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/index.html. For information on HHCAHPS measures see https://homehealthcahps.org/SurveyandProtocols/SurveyMaterials.aspx.
** Because the proposed Total Normalized Composite Change in Self-Care and Mobility measures are composite measures rather than simply outcome measures,
the terms ``Numerator'' and ``Denominator'' do not apply.
We invite public comment on the proposals to remove two OASIS-based
measures, Influenza Immunization Received for Current Flu Season and
Pneumococcal Polysaccharide Vaccine Ever Received, from the set of
applicable measures for PY4 and subsequent performance years. We also
invite public comment on the proposals to replace three OASIS-based
measures, Improvement in Ambulation-Locomotion, Improvement in Bed
Transferring, and Improvement in Bathing, with two proposed composite
measures, Total Normalized Composite Change in Self-Care and Total
Normalized Composite Change in Mobility, for PY4 and subsequent
performance years.
3. Proposal To Reweight the OASIS-Based, Claims-Based, and HHCAHPS
Measures
In the CY 2016 HH PPS final rule, we finalized weighting measures
within each of the HHVBP Model's four classifications (Clinical Quality
of Care, Care Coordination and Efficiency, Person and Caregiver-
Centered Experience, and New Measures) the same for the purposes of
payment adjustment. We finalized weighting each individual measure
equally because we did not want any one measure within a classification
to be more important than another measure, to encourage HHAs to
approach quality improvement initiatives more broadly, and to address
concerns where HHAs may be providing services to beneficiaries with
different needs. Under this approach, a measure's weight remains the
same even if some of the measures within a classification group have no
available data. We stated that in subsequent years of the Model, we
would monitor the impact of equally weighting the individual measures
and may consider changes to the weighting methodology after analysis
and in rulemaking (80 FR 68679).
For PY4 and subsequent performance years, we are proposing to
revise how we weight the individual measures and to amend Sec.
484.320(c) accordingly. Specifically, we are proposing to change our
methodology for calculating the Total Performance Score (TPS) by
weighting the measure categories so that the OASIS-based measure
category and the claims-based measure category would each count for 35
percent and the HHCAHPS measure category would count for 30 percent of
the 90 percent of the TPS that is based on performance of the Clinical
Quality of Care, Care Coordination and Efficiency, and Person and
Caregiver-Centered Experience measures. Note that these measures and
their proposed revised weights would continue to account for the 90
percent of the TPS that is based on the Clinical Quality of Care, Care
Coordination and Efficiency, and Person and Caregiver-Centered
Experience measures. Data reporting for each New Measure would continue
to have equal weight and account for the 10 percent of the TPS that is
based on the New Measures collected as part of the Model. As discussed
further below, we believe that this proposed reweighting, to allow for
more weight for the claims-based measures, would better support
improvement in those measures.
Weights would also be adjusted under this proposal for HHAs that
are missing entire measure categories. For example,
[[Page 32432]]
if an HHA is missing all HHCAHPS measures, the OASIS and claims-based
measure categories would both have the same weight (50 percent each).
We believe that this approach would also increase the weight given to
the claims-based measures, and as a result give HHAs more incentive to
focus on improving them. Additionally, if measures within a category
are missing, the weights of the remaining measures within that measure
category would be adjusted proportionally, while the weight of the
category as a whole would remain consistent. We are also proposing that
the weight of the Acute Care Hospitalization: Unplanned Hospitalization
during first 60 days of Home Health claims-based measure would be
increased so that it has three times the weight of the Emergency
Department Use without Hospitalization claims-based measure, based on
our understanding that HHAs may have more control over the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health claims-based measure. In addition, because inpatient
hospitalizations generally cost more than ED visits, we believe
improvement in the Acute Care Hospitalization: Unplanned
Hospitalization during first 60 days of Home Health claims-based
measure may have a greater impact on Medicare expenditures.
We are proposing to reweight the measures based on our ongoing
monitoring and analysis of claims and OASIS-based measures, which shows
that there has been a steady improvement in OASIS-based measures, while
improvement in claims-based measures has been relatively flat. For
example, Figures 5 and 6 show the change in average performance for the
claims-based and OASIS-based performance measures used in the Model.
For both figures, we report the trends observed in Model and non-Model
states. In both Model and non-Model states, there has been a slight
increase (indicating worse performance) in the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health measure. For all OASIS-based measures, except the Improvement in
Management of Oral Medications measure and the Discharge to Community
measure, there has been substantial improvement in both Model and non-
Model states. Given these results, we believe that increasing the
weight given to the claims-based measures, and the Acute Care
Hospitalization: Unplanned Hospitalization during first 60 days of Home
Health measure in particular, may give HHAs greater incentive to focus
on quality improvement in the claims-based measures. Increasing the
weight of the claims-based measures was also supported by the
contractor's TEP.
BILLING CODE 4120-01-P
TP12JY18.004
[[Page 32433]]
TP12JY18.005
Table 52 shows the current and proposed weights for each measure
based on this proposal to change the weighting methodology from
weighting each individual measure equally to weighting the OASIS,
claims-based, and HHCAHPS measure categories at 35-percent, 35-percent
and 30-percent, respectively. Table 52 also shows the proposed
weighting methodology based on various scoring scenarios. For example,
for HHAs that are exempt from their beneficiaries completing HHCAHPS
surveys, the total weight given to OASIS-based measures scores would be
50 percent, with all OASIS-based measures (other than the two proposed
composite measures) accounting for an equal proportion of that 50
percent, and the total weight given to the claims-based measures scores
would be 50 percent, with the Acute Care Hospitalization: Unplanned
Hospitalizations measure accounting for 37.50 percent and the ED Use
without Hospitalization measure accounting for 12.50 percent. Finally,
Table 52 shows the change in the number of HHAs, by size, that would
qualify for a TPS and payment adjustment under the current and proposed
weighting methodologies, using CY 2016 data. We note that Table 52
reflects only the proposed changes to the weighting methodology and not
the other proposed changes to the HHVBP model for CY 2019 which, if
finalized, would change the proposed weights as set forth in Table 52.
We refer readers to Table 65 in section X. of this proposed rule, which
reflects the weighting that would apply if all of our proposed changes,
including the proposed changes to the applicable measure set, are
adopted for CY 2019. As reflected in that table, the two proposed
composite measures, if finalized, would have weights of 7.5 percent
when all three measure categories are reported.
[[Page 32434]]
TP12JY18.006
BILLING CODE 4120-01-C
We invite public comment on the proposal to reweight the measures
within the Clinical Quality of Care, Care Coordination and Efficiency,
and Person and Caregiver-Centered Experience classifications so that
the OASIS-based measures account for 35-percent, the claims-based
measures account for 35-percent, and the HHCAHPS account for 30-percent
of the 90 percent of the TPS that is based on performance on these
[[Page 32435]]
measures, for PY4 and subsequent performance years. We are also
proposing to amend Sec. 484.320 to reflect these proposed changes.
Specifically, we are proposing to amend Sec. 484.320 to state that for
performance years 4 and 5, CMS will sum all points awarded for each
applicable measure within each category of measures (OASIS-based,
claims-based, and HHCAHPS) excluding the New Measures, weighted at 35-
percent for the OASIS-based measure category, 35-percent for the
claims-based measure category, and 30-percent for the HHCAHPS measure
category, to calculate a value worth 90-percent of the Total
Performance Score. Table 53 is a sample calculation to show how this
proposal, in connection with the proposed changes to the measure set,
would affect scoring under the model as set forth in prior rulemaking
(80 FR 68679 through 68686) when all three measure categories are
reported.
Table 53--Sample HHVBP Total Performance Score Calculation Under Current and Proposed Weights for Individual
Performance Measures
----------------------------------------------------------------------------------------------------------------
Points for Points for
current Current weight proposed Proposed Weighted
measures (%) measures weight (%) points
----------------------------------------------------------------------------------------------------------------
OASIS:
Composite self-care......... N/A 0.00 7.661 7.50 9.19
Composite mobility.......... N/A 0.00 5.299 7.50 6.36
Flu vaccine ever received... 7.662 6.25 N/A 0.00 N/A
Pneumococcal vaccine........ 8.162 6.25 N/A 0.00 N/A
Improvement in bathing...... 5.064 6.25 N/A 0.00 N/A
Improvement in bed transfer. 4.171 6.25 N/A 0.00 N/A
Improvement in ambulation... 3.725 6.25 N/A 0.00 N/A
Improve oral meds........... 3.302 6.25 3.302 5.00 2.64
Improve Dyspnea............. 4.633 6.25 4.633 5.00 3.71
Improve Pain................ 4.279 6.25 4.279 5.00 3.42
Discharge to community...... 0.618 6.25 0.618 5.00 0.49
Claims:
Outpatient ED............... 0 6.25 0 8.75 0.00
Hospitalizations............ 1.18 6.25 1.18 26.25 4.96
HHCAHPS:
Care of patients............ 10 6.25 10 6.00 9.60
Communication between 10 6.25 10 6.00 9.60
provider and patient.......
Discussion of special care 10 6.25 10 6.00 9.60
issues.....................
Overall rating of care...... 5.921 6.25 5.921 6.00 5.68
Willingness to recommend HHA 8.406 6.25 8.406 6.00 8.07
to family and friends......
-------------------------------------------------------------------------------
Total................... 87.123 100.00 .............. 100.00 57.776
----------------------------------------------------------------------------------------------------------------
Total performance score calculation Current Proposed
------------------------------------------------------------------------
Raw score............................... 87.123 57.776
Scaled score (adjusted for # of measures 58.082 57.776
present)...............................
Weighted score (90% of scaled score).... 52.274 51.998
New measure score....................... 100.000 100.000
Weighted new measure score (10% of new 10 10
measure score).........................
TPS (sum of weighted score and weighted 62.274 61.998
new measure score).....................
------------------------------------------------------------------------
C. Performance Scoring Methodology
1. Proposal To Rescore the Maximum Amount of Improvement Points
In the CY 2016 HH PPS final rule, we finalized that an HHA could
earn 0-10 points based on how much its performance in the performance
period improved from its performance on each measure in the Clinical
Quality of Care, Care Coordination and Efficiency, and Person and
Caregiver-Centered Experience classifications during the baseline
period. We noted, in response to public comment about our scoring
methodology for improvement points, that we would monitor and evaluate
the impact of awarding an equal amount of points for both achievement
and improvement and may consider changes to the weight of the
improvement score relative to the achievement score in future years
through rulemaking (80 FR 68682).
We are proposing to reduce the maximum amount of improvement
points, from 10 points to 9 points, for PY4 and subsequent performance
years for all measures except for, if finalized, the Total Normalized
Composite Change in Self-Care and Total Normalized Composite Change in
Mobility measures, for which the maximum improvement points would be
13.5. The maximum score of 13.5 represents 90-percent of the maximum 15
points that could be earned for each of the two proposed composite
measures. The HHVBP Model focuses on having all HHAs provide high
quality care and we believe that awarding more points for achievement
than for improvement beginning with PY4 of the model would support this
goal. We expect that at this point several years into participation in
the Model, participating HHAs have had enough time to make the
necessary investments in quality improvement efforts to support a
higher level of care, warranting a slightly stronger focus on
achievement over improvement on measure performance.
We believe that reducing the maximum improvement points to 9 would
encourage HHAs to focus on achieving higher performance levels and
incentivizing in this manner would encourage HHAs to rely less on their
improvement and more on their achievement.
This proposal would also be consistent with public comments, and
suggestions provided by our contractor's TEP. As summarized in the CY
2016 HH PPS final rule, we received comments encouraging us to focus on
rewarding
[[Page 32436]]
the achievement of specified quality scores, and reduce the emphasis on
improvement scores after the initial 3 years of the HHVBP Model. Some
commenters suggested measuring performance primarily based on
achievement of specified quality scores with a declining emphasis over
time on improvement versus achievement (80 FR 68682).
The TEP also agreed with reducing the maximum number of improvement
points, which they believed would better encourage HHAs to pursue
improved health outcomes for beneficiaries. We note that for the
Hospital Value-Based Purchasing (HVBP) Program, CMS finalized a scoring
methodology where hospitals could earn a maximum of 9 improvement
points if their improvement score falls between the improvement
threshold and the benchmark (76 FR 26515). Similarly, HHVBP is now
proposing a scoring methodology where HHAs could earn a maximum of 9
improvement points.
We propose that an HHA would earn 0-9 points based on how much its
performance during the performance period improved from its performance
on each measure in the Clinical Quality of Care, Care Coordination and
Efficiency, and Person and Caregiver-Centered Experience
classifications during the baseline period. A unique improvement range
for each measure would be established for each HHA that defines the
difference between the HHA's baseline period score and the same state
level benchmark for the measure used in the achievement scoring
calculation, according to the proposed improvement formula. If an HHA's
performance on the measure during the performance period was--
Equal to or higher than the benchmark score, the HHA could
receive an improvement score of 9 points (an HHA with performance equal
to or higher than the benchmark score could still receive the maximum
of 10 points for achievement);
Greater than its baseline period score but below the
benchmark (within the improvement range), the HHA could receive an
improvement score of 0-9 (except for, if finalized, the Total
Normalized Composite Change in Self-Care and Total Normalized Composite
Change in Mobility measures, for which the maximum improvement score
would be 15) for each of the two proposed composite measures) based on
the formula and as illustrated in the examples below; or,
Equal to or lower than its baseline period score on the
measure, the HHA could receive zero points for improvement.
TP12JY18.007
2. Examples of Calculating Achievement and Improvement Scores
For illustrative purposes we present the following examples of how
the proposed changes to the performance scoring methodology would be
applied in the context of the measures in the Clinical Quality of Care,
Care Coordination and Efficiency, and Person and Caregiver Centered
Experience classifications. These HHA examples are based on data from
2015 (for the baseline period) and 2016 (for the performance year).
Figure 7 shows the scoring for HHA `A' as an example. The benchmark
calculated for the improvement in pain measure is 97.676 for HHA A
(note that the benchmark is calculated as the mean of the top decile in
the baseline period for the state). The achievement threshold was
75.358 (this is defined as the performance of the median or the 50th
percentile among HHAs in the baseline period for the state). HHA A's
Year 1 performance rate for the measure was 98.348, which exceeds the
benchmark so the HHA earned the maximum 10 points based on its
achievement score. Its improvement score is irrelevant in the
calculation because measure performance exceeded the benchmark.
Figure 7 also shows the scoring for HHA `B.' As referenced below,
HHA B's performance on this measure went from 52.168 (which was below
the achievement threshold) in the baseline period to 76.765 (which is
above the achievement threshold) in the performance period. Applying
the achievement scale, HHA B' would earn 1.067 points for achievement,
calculated as follows: 9 * (76.765 - 75.358)/(97.676 - 75.358) + 0.5 =
1.067.\62\ Calculating HHA B's improvement score yields the following
result: based on HHA B's period-to-period improvement, from 52.168 in
the baseline year to 76.765 in the performance year, HHA B would earn
4.364 points, calculated as follows: 9 * (76.765 - 52.168)/(97.676 -
75.358) - 0.5 = 4.364.\63\ Because the higher of the achievement and
improvement scores is used, HHA B would receive 4.364 points for this
measure.
---------------------------------------------------------------------------
\62\ Achievement points are calculated as 9 * (HHA Performance
Year Score - Achievement Threshold)/(Benchmark - Achievement
threshold) + 0.5.
\63\ The formula for calculating improvement points is 9 * (HHA
Performance Year Score - HHA Baseline Period Score)/(HHA Benchmark -
HHA Baseline Period Score) - 0.5.
---------------------------------------------------------------------------
In Figure 8, HHA `C' yielded a decline in performance on the
improvement in pain measure, falling from 70.266 to 58.487. HHA C's
performance during the performance period was lower than the
achievement threshold of 75.358 and, as a result, the HHA would receive
0 points based on achievement. It would also receive 0 points for
improvement, because its performance during the performance period was
lower than its performance during the baseline period.
BILLING CODE 4120-01-P
[[Page 32437]]
TP12JY18.008
[[Page 32438]]
TP12JY18.009
BILLING CODE 4120-01-C
We would monitor and evaluate the impact of reducing the maximum
improvement points to 9 and would consider whether to propose more
changes to the weight of the improvement score relative to the
achievement score in future years through rulemaking.
We invite public comment on the proposal to reduce the maximum
amount of improvement points, from 10 points to 9 points for PY 4 and
subsequent performance years.
D. Update on the Public Display of Total Performance Scores
In the CY 2016 HH PPS final rule (80 FR 68658), we stated that one
of the three goals of the HHVBP Model is to enhance the current public
reporting processes. We reiterated this goal and continued discussing
the public display of HHAs' Total Performance Scores (TPSs) in the CY
2017 HH PPS final rule (81 FR 76751 through 76752). We believe that
publicly reporting a participating HHA's TPS will encourage providers
and patients to use this information when selecting an HHA to provide
quality care. We are encouraged by the previous stakeholder comments
and support for public reporting that could assist patients,
physicians, discharge planners, and other referral sources to choose
higher-performing HHAs.
In the CY 2017 HH PPS final rule, we noted that one commenter
suggested that we not consider public display until after the Model was
evaluated. Another commenter favored the public display of the TPS, but
recommended that CMS use a transparent process and involve stakeholders
in deciding what will be reported, and provide a review period with a
process for review and appeal before reporting.
As discussed in the CY 2017 HH PPS final rule, we are considering
public reporting for the HHVBP Model after allowing analysis of at
least eight quarters of performance data for the Model and the
opportunity to compare how these results align with other publicly
reported quality data (81 FR 76751). While we are not making a specific
proposal at this time, we are soliciting further public comment on what
information, specifically from the CY 2017 Annual Total Performance
Score and Payment Adjustment Reports and subsequent annual reports,
should be made publicly available. We note that HHAs have the
opportunity to review and appeal their Annual Total Performance Score
and Payment Adjustment Reports as outlined in the appeals process
finalized in the CY 2017 HH PPS final rule (81 FR 76747 through 76750).
Examples of the information included in the Annual Total Performance
Score and Payment Adjustment Report include the agency: Name, address,
TPS, payment adjustment percentage, performance information for each
measure used in the Model (for example, quality measure scores,
achievement, and improvement points), state and cohort information, and
percentile ranking. Based on the public comments received, we will
consider what information, specifically from the annual reports, we may
[[Page 32439]]
consider proposing for public reporting in future rulemaking.
V. Proposed Updates to the Home Health Quality Reporting Program (HH
QRP)
A. Background and Statutory Authority
Section 1895(b)(3)(B)(v)(II) of the Social Security Act (the Act)
requires that for 2007 and subsequent years, each HHA submit to the
Secretary in a form and manner, and at a time, specified by the
Secretary, such data that the Secretary determines are appropriate for
the measurement of health care quality. To the extent that an HHA does
not submit data with respect to a year in accordance with this clause,
the Secretary is directed to reduce the HH market basket percentage
increase applicable to the HHA for such year by 2 percentage points. As
provided at section 1895(b)(3)(B)(vi) of the Act, depending on the
market basket percentage increase applicable for a particular year, for
2015 and each subsequent year (except 2018), the reduction of that
increase by 2 percentage points for failure to comply with the
requirements of the HH QRP and further reduction of the increase by the
productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
the Act may result in the home health market basket percentage increase
being less than 0.0 percent for a year, and may result in payment rates
under the Home Health PPS for a year being less than payment rates for
the preceding year.
For more information on the policies we have adopted for the HH
QRP, we refer readers to the CY 2007 HH PPS final rule (71 FR 65888
through 65891), the CY 2008 HH PPS final rule (72 FR 49861 through
49864), the CY 2009 HH PPS update notice (73 FR 65356), the CY 2010 HH
PPS final rule (74 FR 58096 through 58098), the CY 2011 HH PPS final
rule (75 FR 70400 through 70407), the CY 2012 HH PPS final rule (76 FR
68574), the CY 2013 HH PPS final rule (77 FR 67092), the CY 2014 HH PPS
final rule (78 FR 72297), the CY 2015 HH PPS final rule (79 FR 66073
through 66074), the CY 2016 HH PPS final rule (80 FR 68690 through
68695), the CY 2017 HH PPS final rule (81 FR 76752), and the CY 2018 HH
PPS final rule (82 FR 51711 through 51712).
Although we have historically used the preamble to the HH PPS
proposed and final rules each year to remind stakeholders of all
previously finalized program requirements, we have concluded that
repeating the same discussion each year is not necessary for every
requirement, especially if we have codified it in our regulations.
Accordingly, the following discussion is limited as much as possible to
a discussion of our proposals for future years of the HH QRP, and
represents the approach we intend to use in our rulemakings for this
program going forward.
B. General Considerations Used for the Selection of Quality Measures
for the HH QRP
1. Background
For a detailed discussion of the considerations we historically
used for measure selection for the HH QRP quality, resource use, and
others measures, we refer readers to the CY 2016 HH PPS final rule (80
FR 68695 through 68696).
2. Accounting for Social Risk Factors in the HH QRP Program
In the CY 2018 HH PPS final rule (82 FR 51713 through 51714) we
discussed the importance of improving beneficiary outcomes including
reducing health disparities. We also discussed our commitment to
ensuring that medically complex patients, as well as those with social
risk factors, receive excellent care. We discussed how studies show
that social risk factors, such as being near or below the poverty level
as determined by HHS, belonging to a racial or ethnic minority group,
or living with a disability, can be associated with poor health
outcomes and how some of this disparity is related to the quality of
health care.\64\ Among our core objectives, we aim to improve health
outcomes, attain health equity for all beneficiaries, and ensure that
complex patients as well as those with social risk factors receive
excellent care. Within this context, reports by the Office of the
Assistant Secretary for Planning and Evaluation (ASPE) and the National
Academy of Medicine have examined the influence of social risk factors
in our value-based purchasing programs.\65\ As we noted in the CY 2018
HH PPS final rule (82 FR 51713 through 51714), ASPE's report to
Congress, which was required by the IMPACT Act, found that, in the
context of value based purchasing programs, dual eligibility was the
most powerful predictor of poor health care outcomes among those social
risk factors that they examined and tested. ASPE is continuing to
examine this issue in its second report required by the IMPACT Act,
which is due to Congress in the fall of 2019. In addition, as we noted
in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38428 through 38429),
the National Quality Forum (NQF) undertook a 2-year trial period in
which certain new measures and measures undergoing maintenance review
have been assessed to determine if risk adjustment for social risk
factors is appropriate for these measures.\66\ The trial period ended
in April 2017 and a final report is available at: http://www.qualityforum.org/SES_Trial_Period.aspx. The trial concluded that
``measures with a conceptual basis for adjustment generally did not
demonstrate an empirical relationship'' between social risk factors and
the outcomes measured. This discrepancy may be explained in part by the
methods used for adjustment and the limited availability of robust data
on social risk factors. NQF has extended the socioeconomic status (SES)
trial,\67\ allowing further examination of social risk factors in
outcome measures.
---------------------------------------------------------------------------
\64\ See, for example United States Department of Health and
Human Services. ``Healthy People 2020: Disparities. 2014.''
Available at: http://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities; or National Academies of Sciences,
Engineering, and Medicine. Accounting for Social Risk Factors in
Medicare Payment: Identifying Social Risk Factors. Washington, DC:
National Academies of Sciences, Engineering, and Medicine 2016.
\65\ Department of Health and Human Services Office of the
Assistant Secretary for Planning and Evaluation (ASPE), ``Report to
Congress: Social Risk Factors and Performance under Medicare's
Value-Based Purchasing Programs.'' December 2016. Available at:
https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
\66\ Available at http://www.qualityforum.org/SES_Trial_Period.aspx.
\67\ Available at: http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=86357.
---------------------------------------------------------------------------
In the CY 2018/FY 2018 proposed rules for our quality reporting and
value-based purchasing programs, we solicited feedback on which social
risk factors provide the most valuable information to stakeholders and
the methodology for illuminating differences in outcomes rates among
patient groups within a provider that would also allow for a comparison
of those differences, or disparities, across providers. Feedback we
received across our quality reporting programs included encouraging CMS
to explore whether factors could be used to stratify or risk adjust the
measures (beyond dual eligibility), to consider the full range of
differences in patient backgrounds that might affect outcomes, to
explore risk adjustment approaches, and to offer careful consideration
of what type of information display would be most useful to the public.
We also sought public comment on confidential reporting and future
public reporting of some of our measures stratified by patient dual
eligibility. In
[[Page 32440]]
general, commenters noted that stratified measures could serve as tools
for hospitals to identify gaps in outcomes for different groups of
patients, improve the quality of health care for all patients, and
empower consumers to make informed decisions about health care.
Commenters encouraged us to stratify measures by other social risk
factors such as age, income, and educational attainment. With regard to
value-based purchasing programs, commenters also cautioned CMS to
balance fair and equitable payment while avoiding payment penalties
that mask health disparities or discouraging the provision of care to
more medically complex patients. Commenters also noted that value-based
payment program measure selection, domain weighting, performance
scoring, and payment methodology must account for social risk.
As a next step, we are considering options to improve health
disparities among patient groups within and across hospitals by
increasing the transparency of disparities as shown by quality
measures. We also are considering how this work applies to other CMS
quality programs in the future. We refer readers to the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38403 through 38409) for more details, where
we discuss the potential stratification of certain Hospital IQR Program
outcome measures. Furthermore, we continue to consider options to
address equity and disparities in our value-based purchasing programs.
We plan to continue working with ASPE, the public, and other key
stakeholders on this important issue to identify policy solutions that
achieve the goals of attaining health equity for all beneficiaries and
minimizing unintended consequences.
C. Proposed Removal Factors for Previously Adopted HH QRP Measures
As a part of our Meaningful Measures Initiative, discussed in
section I.D.1 of this proposed rule, we strive to put patients first,
ensuring that they, along with their clinicians, are empowered to make
decisions about their own healthcare using data-driven information that
is increasingly aligned with a parsimonious set of meaningful quality
measures. We began reviewing the HH QRP measure set in accordance with
the Meaningful Measures Initiative discussed in section I.D.1 of this
proposed rule, and we are working to identify how to move the HH QRP
forward in the least burdensome manner possible, while continuing to
prioritize and incentivize improvement in the quality of care provided
to patients.
Specifically, we believe the goals of the HH QRP and the measures
used in the program overlap with the Meaningful Measures Initiative
priorities, including making care safer, strengthening person and
family engagement, promoting coordination of care, promoting effective
prevention and treatment, and making care affordable.
We also evaluated the appropriateness and completeness of the HH
QRP's current measure removal factors. In the CY 2017 HH PPS final rule
(81 FR 76754 through 76755), we adopted a process for retaining,
removing, and replacing previously adopted HH QRP measures. To be
consistent with other established quality reporting programs, we are
proposing to replace the six criteria used when considering a quality
measure for removal, finalized in the CY 2017 HH PPS final rule (81 FR
76754 through 76755), with the following seven measure removal factors,
finalized for the LTCH QRP in the FY 2013 IPPS/LTCH PPS final rule (77
FR 53614 through 53615), for the SNF QRP in the FY 2016 SNF PPS final
rule (80 FR 46431 through 46432), and for the IRF QRP in the CY 2013
OPPS/ASC final rule (77 FR 68502 through 68503), for use in the HH QRP:
Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
Factor 2. Performance or improvement on a measure does not
result in better patient outcomes.
Factor 3. A measure does not align with current clinical
guidelines or practice.
Factor 4. A more broadly applicable measure (across
settings, populations, or conditions) for the particular topic is
available.
Factor 5. A measure that is more proximal in time to
desired patient outcomes for the particular topic is available.
Factor 6. A measure that is more strongly associated with
desired patient outcomes for the particular topic is available.
Factor 7. Collection or public reporting of a measure
leads to negative unintended consequences other than patient harm.
We believe these measure removal factors are substantively
consistent with the criteria we previously adopted (only we are
changing the terminology to call them ``factors'') and appropriate for
use in the HH QRP. However, even if one or more of the measure removal
factors applies, we might nonetheless choose to retain the measure for
certain specified reasons. Examples of such instances could include
when a particular measure addresses a gap in quality that is so
significant that removing the measure could result in poor quality, or
in the event that a given measure is statutorily required. Furthermore,
we note that consistent with other quality reporting programs, we apply
these factors on a case-by-case basis.
We finalized in the CY 2017 HH PPS final rule (81 FR 76755) that
removal of a HH QRP measure would take place through notice and comment
rulemaking, unless we determined that a measure was causing concern for
patient safety. Specifically, in the case of a HH QRP measure for which
there was a reason to believe that the continued collection raised
possible safety concerns, we would promptly remove the measure and
publish the justification for the removal in the Federal Register
during the next rulemaking cycle. In addition, we would immediately
notify HHAs and the public through the usual communication channels,
including listening sessions, memos, email notification, and Web
postings. If we removed a measure from the HH QRP under these
circumstances but also collected data on that measure under different
statutory authority for a different purpose, we would notify
stakeholders that we would also cease collecting the data under that
alternative statutory authority.
In this proposed rule, we are proposing to adopt an additional
factor to consider when evaluating potential measures for removal from
the HH QRP measure set:
Factor 8. The costs associated with a measure outweigh the
benefit of its continued use in the program.
As we discussed in section I.D.1 of this proposed rule, with
respect to our new Meaningful Measures Initiative, we are engaging in
efforts to ensure that the HH QRP measure set continues to promote
improved health outcomes for beneficiaries while minimizing the overall
costs associated with the program. We believe these costs are
multifaceted and include not only the burden associated with reporting,
but also the costs associated with implementing and maintaining the
program. We have identified several different types of costs,
including, but not limited to the following:
Provider and clinician information collection burden and
burden associated with the submitting/reporting of quality measures to
CMS.
The provider and clinician cost associated with complying
with other HH programmatic requirements.
[[Page 32441]]
The provider and clinician cost associated with
participating in multiple quality programs, and tracking multiple
similar or duplicative measures within or across those programs.
The cost to CMS associated with the program oversight of
the measure, including measure maintenance and public display.
The provider and clinician cost associated with compliance
with other federal and state regulations (if applicable).
For example, it may be of limited benefit to retain or maintain a
measure which our analyses show no longer meaningfully supports program
objectives (for example, informing beneficiary choice). It may also be
costly for HHAs to track confidential feedback, preview reports, and
publicly reported information on a measure where we use the measure in
more than one program. We may also have to expend resources to maintain
the specifications for the measure, including the tools needed to
collect, validate, analyze, and publicly report the measure data.
When these costs outweigh the evidence supporting the continued use
of a measure in the HH QRP, we believe it may be appropriate to remove
the measure from the program. Although we recognize that one of the
main goals of the HH QRP is to improve beneficiary outcomes by
incentivizing health care providers to focus on specific care issues
and making public data related to those issues, we also recognize that
those goals can have limited utility where, for example, the publicly
reported data is of limited use because it cannot be easily interpreted
by beneficiaries and used to influence their choice of providers. In
these cases, removing the measure from the HH QRP may better
accommodate the costs of program administration and compliance without
sacrificing improved health outcomes and beneficiary choice.
We are proposing that we would remove measures based on proposed
Factor 8 on a case-by-case basis. For example, we may decide to retain
a measure that is burdensome for HHAs to report if we conclude that the
benefit to beneficiaries is so high that it justifies the reporting
burden. Our goal is to move the HH QRP program forward in the least
burdensome manner possible, while maintaining a parsimonious set of
meaningful quality measures and continuing to incentivize improvement
in the quality of care provided to patients.
We are inviting public comment on our proposals to replace the six
criteria used when considering a quality measure for removal with the
seven measure removal factors currently adopted in the LTCH QRP, IRF
QRP, and SNF QRP. We are also inviting public comment on our proposal
to adopt new measure removal Factor 8. The costs associated with a
measure outweigh the benefit of its continued use in the program.
D. Quality Measures Currently Adopted for the HH QRP
The HH QRP currently has 31 measures for the CY 2020 program year,
as outlined in Table 54.
Table 54--Measures Currently Adopted for the CY 2020 HH QRP
------------------------------------------------------------------------
Measure name &
Short name data source
------------------------------------------------------------------------
OASIS-Based
------------------------------------------------------------------------
Ambulation............................................ Improvement in
Ambulation/
Locomotion (NQF
#0167).
Application of Falls.................................. Application of
Percent of
Residents
Experiencing
One or More
Falls with
Major Injury
(Long Stay)
(NQF #0674).
Application of Functional Assessment.................. Application of
Percent of Long-
Term Care
Hospital (LTCH)
Patients with
an Admission
and Discharge
Functional
Assessment and
a Care Plan
That Addresses
Function (NQF
#2631).
Bathing............................................... Improvement in
Bathing (NQF
#0174).
Bed Transferring...................................... Improvement in
Bed
Transferring
(NQF #0175).
Depression Assessment................................. Depression
Assessment
Conducted.
Diabetic Foot Care.................................... Diabetic Foot
Care and
Patient/
Caregiver
Education
Implemented
during All
Episodes of
Care (#0519).
DRR................................................... Drug Regimen
Review
Conducted With
Follow-Up for
Identified
Issues--Post
Acute Care
(PAC) HH QRP.
Drug Education........................................ Drug Education
on All
Medications
Provided to
Patient/
Caregiver
during All
Episodes of
Care.
Dyspnea............................................... Improvement in
Dyspnea.
Falls Risk............................................ Multifactor Fall
Risk Assessment
Conducted For
All Patients
Who Can
Ambulate (NQF
#0537).
Influenza............................................. Influenza
Immunization
Received for
Current Flu
Season (NQF
#0522).
Oral Medications...................................... Improvement in
Management of
Oral
Medications
(NQF #0176).
Pain.................................................. Improvement in
Pain
Interfering
with Activity
(NQF #0177).
PPV................................................... Pneumococcal
Polysaccharide
Vaccine Ever
Received.
Pressure Ulcer/Injury................................. Percent of
Residents or
Patients With
Pressure Ulcers
That Are New or
Worsened (Short
Stay) (NQF
#0678), removed
as of January
1, 2019.
Changes in Skin
Integrity Post-
Acute Care:
Pressure Ulcer/
Injury measure,
effective
January 1,
2019.
Surgical Wounds....................................... Improvement in
Status of
Surgical Wounds
(NQF #0178).
Timely Care........................................... Timely
Initiation Of
Care (NQF
#0526).
-------------------------------------------------------
Claims-Based
------------------------------------------------------------------------
ACH................................................... Acute Care
Hospitalization
During the
First 60 Days
of HH (NQF
#0171).
DTC................................................... Discharge to
Community-Post
Acute Care
(PAC) Home
Health (HH)
Quality
Reporting
Program (QRP).
ED Use................................................ Emergency
Department Use
without
Hospitalization
During the
First 60 Days
of HH (NQF
#0173).
ED Use without Readmission............................ Emergency
Department Use
without
Hospital
Readmission
During the
First 30 Days
of HH (NQF
#2505).
MSPB.................................................. Total Estimated
Medicare
Spending Per
Beneficiary
(MSPB)--Post
Acute Care
(PAC) HH QRP.
PPR................................................... Potentially
Preventable 30-
Day Post-
Discharge
Readmission
Measure for HH
Quality
Reporting
Program.
[[Page 32442]]
Rehospitalization..................................... Rehospitalizatio
n During the
First 30 Days
of HH (NQF
#2380).
-------------------------------------------------------
HHCAHPS-Based
------------------------------------------------------------------------
Communication......................................... How well did the
home health
team
communicate
with patients.
Overall Rating........................................ How do patients
rate the
overall care
from the home
health agency.
Professional Care..................................... How often the
home health
team gave care
in a
professional
way.
Team Discussion....................................... Did the home
health team
discuss
medicines,
pain, and home
safety with
patients.
Willing to Recommend.................................. Will patients
recommend the
home health
agency to
friends and
family.
------------------------------------------------------------------------
E. Proposed Removal of HH QRP Measures Beginning With the CY 2021 HH
QRP
To address the Meaningful Measures Initiative described in section
I.D.1 of this proposed rule, we are proposing to remove seven measures
from the HH QRP beginning with the CY 2021 HH QRP.
1. Proposed Removal of the Depression Assessment Conducted Measure
We are proposing to remove the Depression Assessment Conducted
Measure from the HH QRP beginning with the CY 2021 HH QRP under our
proposed Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Depression Assessment Conducted Measure beginning with the
CY 2010 HH QRP. Depression in the elderly is associated with
disability, impaired well-being, service utilization,\68\ and
mortality.\69\ This process measure reports the percentage of HH
episodes in which patients were screened for depression (using a
standardized depression screening tool) at start of care/resumption of
care (SOC/ROC). The measure is calculated solely using the OASIS Item
M1730, Depression Screening.\70\ Item M1730 is additionally used at
SOC/ROC as a risk adjuster in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP.\71\
---------------------------------------------------------------------------
\68\ Beekman A.T., Deeg D.J., Braam A.W., et al.: Consequences
of major and minor depression in later life: A study of disability,
well-being and service utilization. Psychological Medicine 27:1397-
1409, 1997.
\69\ Schulz, R., Beach, S.R., Ives, D.G., Martire, L.M., Ariyo,
A.A., & Kop, W.J. (2000). Association between depression and
mortality in older adults--The Cardiovascular Health Study. Archives
of Internal Medicine, 160(12), 1761-1768.
\70\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
\71\ The OASIS-based HH QRP outcome measures that use OASIS Item
M1730 as a risk adjuster in the calculation of the measure are:
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167),
Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), Improvement in Management of Oral Medications
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF
#0178).
---------------------------------------------------------------------------
In our evaluation of the Depression Assessment Conducted Measure,
we found that HHA performance is very high and that meaningful
distinctions in improvements in performance cannot be made. The mean
and median agency performance scores for this measure in 2017 (96.8
percent and 99.2 percent, respectively) when compared to the mean and
median agency performance scores for this measure in 2010 (88.0 percent
and 96.6 percent, respectively) indicate that an overwhelming majority
of patients are screened for depression in the HH setting. Further,
these performance scores demonstrate the improvement in measure
performance since its adoption in the HH QRP. In addition, in 2017 the
75th percentile measure score (100 percent) and the 90th percentile
measure score (100 percent) are statistically indistinguishable from
each other, meaning that the measure scores do not meaningfully
distinguish scores between HHAs. Further, the Truncated Coefficient of
Variation (TCV) \72\ for this measure is 0.03, suggesting that it is
not useful to draw distinctions between individual agency performance
scores for this measure.
---------------------------------------------------------------------------
\72\ The truncated coefficient of variation (TCV) is the ratio
of the standard deviation to the mean of the distribution of all
scores, excluding the 5 percent most extreme scores. A small TCV (<=
0.1) indicates that the distribution of individual scores is
clustered tightly around the mean value, suggesting that it is not
useful to draw distinctions between individual performance scores.
---------------------------------------------------------------------------
For these reasons, we are proposing to remove the Depression
Assessment Conducted Measure from the HH QRP beginning with the CY 2021
HH QRP under our proposed Factor 1. Measure performance among HHAs is
so high and unvarying that meaningful distinctions in improvements in
performance can no longer be made.
If finalized as proposed, HHAs would no longer be required to
submit OASIS Item M1730, Depression Screening at SOC/ROC for the
purposes of this measure beginning January 1, 2020. HHAs would however
continue to submit data on M1730 at the time point of SOC/ROC as a risk
adjuster for several other OASIS-based outcome measures currently
adopted for the HH QRP.\73\ If finalized as proposed, data for this
measure would be publicly reported on HH Compare until January 2021.
---------------------------------------------------------------------------
\73\ The OASIS-based HH QRP outcome measures that use OASIS Item
M1730 as a risk adjuster in the calculation of the measure are:
Improvement in Bathing (NQF #0174), Improvement in Bed Transferring
(NQF #0175), Improvement in Ambulation/Locomotion (NQF #0167),
Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), Improvement in Management of Oral Medications
(NQF #0176), and Improvement in Status of Surgical Wounds (NQF
#0178).
---------------------------------------------------------------------------
We are inviting public comment on this proposal.
2. Proposed Removal of the Diabetic Foot Care and Patient/Caregiver
Education Implemented During All Episodes of Care Measure
We are proposing to remove the Diabetic Foot Care and Patient/
Caregiver Education Implemented during All Episodes of Care Measure
from the HH QRP beginning with the CY 2021 HH QRP under our proposed
Factor 1. Measure performance among HHAs is so high and unvarying that
meaningful distinctions in improvements in performance can no longer be
made.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Diabetic Foot Care and Patient/Caregiver Education
Implemented during All Episodes of Care Measure beginning with the CY
2010 HH QRP. This process measure reports the percentage of HH quality
episodes in which diabetic foot care and patient/caregiver education
were included in the physician-ordered plan of care and
[[Page 32443]]
implemented (at the time of or at any time since the most recent SOC/
ROC assessment). The measure numerator is calculated using OASIS Item
M2401 row a, Intervention Synopsis: Diabetic foot care.\74\
---------------------------------------------------------------------------
\74\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
In our evaluation of the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure, we found
that HHA performance is very high and that meaningful distinctions in
improvements in performance cannot be made. The mean and median agency
performance scores for this measure in 2017 (97.0 percent and 99.2
percent, respectively) when compared to the mean and median agency
performance score for this measure in 2010 (86.2 percent and 91.7
percent, respectively), indicate that an overwhelming majority of HH
episodes for patients with diabetes included education on foot care.
Further, these scores demonstrate the improvement in measure
performance since the Diabetic Foot Care and Patient/Caregiver
Education Implemented during All Episodes of Care Measure's adoption in
the HH QRP. In addition, in 2017 the 75th percentile measure score (100
percent) and the 90th percentile score (100 percent) are statistically
indistinguishable from each other, meaning that the measure scores do
not meaningfully distinguish between HHAs. Further, the TCV for this
measure is 0.03, suggesting that it is not useful to draw distinctions
between individual agency performance scores for this measure.
For these reasons, we are proposing to remove the Diabetic Foot
Care and Patient/Caregiver Education Implemented during All Episodes of
Care Measure from the HH QRP beginning with CY 2021 HH QRP under our
proposed Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
If finalized as proposed, HHAs would no longer be required to
submit OASIS Item M2401 row a, Intervention Synopsis: Diabetic foot
care at the time point of Transfer to an Inpatient Facility (TOC) and
Discharge from Agency--Not to an Inpatient Facility (Discharge) for the
purposes of the HH QRP beginning January 1, 2020. HHAs may enter an
equal sign (=) for M2401, row a, at the time point of TOC and Discharge
on or after January 1, 2020. If finalized as proposed, data for this
measure would be publicly reported on HH Compare until January 2021.
We are inviting public comment on this proposal.
3. Proposed Removal of the Multifactor Fall Risk Assessment Conducted
for All Patients Who Can Ambulate (NQF #0537) Measure
We are proposing to remove the Multifactor Fall Risk Assessment
Conducted for All Patients Who Can Ambulate (NQF #0537) Measure from
the HH QRP beginning with the CY 2021 HH QRP, under our proposed Factor
1. Measure performance among HHAs is so high and unvarying that
meaningful distinctions in improvements in performance can no longer be
made.
In CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Multifactor Fall Risk Assessment Conducted for All Patients
Who Can Ambulate (NQF #0537) Measure \75\ beginning with the CY 2010 HH
QRP. This process measure reports the percentage of HH quality episodes
in which patients had a multifactor fall risk assessment at SOC/ROC.
The measure is calculated using OASIS Item M1910, Falls Risk
Assessment.\76\
---------------------------------------------------------------------------
\75\ At the time, this measure was adopted as ``Falls risk
assessment for patients 65 and older.'' The name of this measure was
updated in the CY 2018 HH PPS final rule (82 FR 51717).
\76\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
In our evaluation of the Multifactor Fall Risk Assessment Conducted
for All Patients Who Can Ambulate (NQF #0537) Measure, we found that
HHA performance is very high and that meaningful distinctions in
improvements in performance cannot be made. The mean and median agency
performance scores for this measure in 2017 (99.3 percent and 100.0
percent, respectively) when compared to the mean and median agency
performance score for this measure in 2010 (94.8 percent and 98.9
percent, respectively), indicate that an overwhelming majority of
patients in an HHA have had a multifactor fall risk assessment at SOC/
ROC and demonstrates the improvement in measure performance since its
adoption. In addition, in 2017 the 75th percentile measure score (100
percent) and the 90th percentile measure score (100 percent) are
statistically indistinguishable from each other, meaning that the
measure scores do not meaningfully distinguish between HHAs. Further,
the TCV for this measure is 0.01, suggesting that it is not useful to
draw distinctions between individual agency performance scores for this
measure.
For these reasons, we are proposing to remove the Multifactor Fall
Risk Assessment Conducted for All Patients Who Can Ambulate (NQF #0537)
Measure from the HH QRP beginning with the CY 2021 HH QRP, under our
proposed Factor 1. Measure performance among HHAs is so high and
unvarying that meaningful distinctions in improvements in performance
can no longer be made.
If finalized as proposed, HHAs would no longer be required to
submit OASIS Item M1910, Falls Risk Assessment at SOC/ROC beginning
January 1, 2020. HHAs may enter an equal sign (=) for M1910 at the time
point of SOC and ROC beginning January 1, 2020. If finalized as
proposed, data for this measure would be publicly reported on HH
Compare until January 2021.
We are inviting public comment on this proposal.
4. Proposed Removal of the Pneumococcal Polysaccharide Vaccine Ever
Received Measure
We are proposing to remove the Pneumococcal Polysaccharide Vaccine
Ever Received Measure from the HH QRP beginning with the CY 2021 HH
QRP, under our proposed Factor 3. A measure does not align with current
clinical guidelines or practice.
In the CY 2010 HH PPS final rule (74 FR 58096 through 58098), we
adopted the Pneumococcal Polysaccharide Vaccine Ever Received Measure
beginning with CY 2010 HH QRP. This process measure reports the
percentage of HH quality episodes during which patients were determined
to have ever received the Pneumococcal Polysaccharide Vaccine. The
measure is calculated using OASIS Items M1051, Pneumococcal Vaccine and
M1056, Reason Pneumococcal Vaccine not received.\77\
---------------------------------------------------------------------------
\77\ Measure specifications can be found in the Home Health
Process Measures Table on the Home Health Quality Measures website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Process-Measures-Table_OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
At the time that this measure was adopted in the HH QRP, the
Advisory Committee on Immunization Practices (ACIP),\78\ which sets
current clinical
[[Page 32444]]
guidelines, recommended use of a single dose of the 23-valent
pneumococcal polysaccharide vaccine (PPSV23) among all adults aged 65
years and older and those adults aged 19 to 64 years with underlying
medical conditions that put them at greater risk for serious
pneumococcal infection.\79\
---------------------------------------------------------------------------
\78\ The Advisory Committee on Immunization Practices was
established under section 222 of the Public Health Service Act (42
U.S.C. 2l7a), as amended, to assist states and their political
subdivisions in the prevention and control of communicable diseases;
to advise the states on matters relating to the preservation and
improvement of the public's health; and to make grants to states
and, in consultation with the state health authorities, to agencies
and political subdivisions of states to assist in meeting the costs
of communicable disease control programs. (Charter of the Advisory
Committee on Immunization Practices, filed April 1, 2018. https://www.cdc.gov/vaccines/acip/committee/ACIP-Charter-2018.pdf.)
\79\ Prevention of Pneumococcal Disease: Recommendations of the
Advisory Committee on Immunization Practices (ACIP), MMWR 1997;46:1-
24.
---------------------------------------------------------------------------
Since this measure was added to the HH QRP, the ACIP has updated
its pneumococcal vaccination recommendations.\80\ Two pneumococcal
vaccines are currently licensed for use in the United States: the 13-
valent pneumococcal conjugate vaccine (PCV13) and the 23-valent
pneumococcal vaccine (PPSV23). The ACIP currently recommends that both
PCV13 and PPSV23 be given to all immunocompetent adults aged >= 65
years. The recommended intervals for sequential administration of PCV13
and PPSV23 depend on several patient factors including: The current age
of the adult, whether the adult had previously received PPSV23, and the
age of the adult at the time of prior PPSV23 vaccination (if
applicable).
---------------------------------------------------------------------------
\80\ Tomczyk S., Bennett N.M., Stoecker C., et al. Use of 13-
valent pneumococcal conjugate vaccine and 23-valent pneumococcal
polysaccharide vaccine among adults aged >=65 years: recommendations
of the Advisory Committee on Immunization Practices (ACIP). MMWR
2014;63: 822-5.
---------------------------------------------------------------------------
The specifications for the Pneumococcal Polysaccharide Vaccine Ever
Received Measure do not fully reflect the current ACIP guidelines.
Therefore, we believe that the Pneumococcal Polysaccharide Vaccine Ever
Received Measure no longer aligns with the current clinical guidelines
or practice. For this reason, we are proposing to remove the
Pneumococcal Polysaccharide Vaccine Ever Received Measure from the HH
QRP beginning with the CY 2021 HH QRP under our proposed Factor 3. A
measure does not align with current clinical guidelines or practice.
If finalized as proposed, HHAs would no longer be required to
submit OASIS Items M1051, Pneumococcal Vaccine and M1056, Reason
Pneumococcal Vaccine not received at the time point of TOC and
Discharge for the purposes of the HH QRP beginning January 1, 2020.
HHAs may enter an equal sign (=) for Items M1051 and M1056 at the time
point of TOC and Discharge on or after January 1, 2020. If finalized as
proposed, data for this measure would be publicly reported on HH
Compare until January 2021.
We are inviting public comment on this proposal.
5. Proposed Removal of the Improvement in the Status of Surgical Wounds
Measure
We are proposing to remove the Improvement in the Status of
Surgical Wounds Measure from the HH QRP beginning with the CY 2021 HH
QRP under our proposed Factor 4. A more broadly applicable measure
(across settings, populations, or conditions) for the particular topic
is available.
In the CY 2008 HH PPS final rule (72 FR 49861 through 49863), we
adopted the Improvement in the Status of Surgical Wounds Measure for
the HH QRP beginning with the CY 2008 program year. This risk-adjusted
outcome measure reports the percentage of HH episodes of care during
which the patient demonstrates an improvement in the condition of skin
integrity related to the surgical wounds. This measure is solely
calculated using OASIS Items M1340, Does this patient have a Surgical
Wound? and M1342, Status of Most Problematic Surgical Wound that is
Observable.\81\ Items M1340 and M1342 are also used at the time points
of SOC/ROC as risk adjusters in the calculation of several other OASIS-
based outcome measures currently adopted for the HH QRP \82\
Additionally, Items M1340 and M1342 are used at the time point of
Discharge for the Potentially Avoidable Events measure Discharged to
the Community Needing Wound Care or Medication Assistance that is used
by HH surveyors during the survey process.\83\
---------------------------------------------------------------------------
\81\ Measure specifications can be found in the Home Health
Outcomes Measures Table on the Home Health Quality Measures website
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-Outcome-Measures-Table-OASIS-C2_4-11-18.pdf).
\82\ The OASIS-based HH QRP outcome measures that use OASIS
Items M1340 and M1342 as a risk adjuster in the calculation of the
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), and Improvement in Management of Oral
Medications (NQF #0176).
\83\ Measure specifications can be found in the Home Health
Potentially Avoidable Events Measures Table on the Home Health
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
The Improvement in the Status of Surgical Wounds Measure is limited
in scope to surgical wounds incurred by surgical patients and excludes
HH episodes of care where the patient, at SOC/ROC, did not have any
surgical wounds or had only a surgical wound that was unobservable or
fully epithelialized. As a result, the majority of HHAs are not able to
report data on the measure and the measure is limited in its ability to
compare how well HHAs address skin integrity. For example, in 2016,
only 13 percent of HH patients had a surgical wound at the beginning of
their HH episode and only 36.6 percent of HHAs were able to report data
on the measure with respect to that year.
In contrast, the Percent of Residents or Patients with Pressure
Ulcers That Are New or Worsened (Short Stay) Measure (NQF #0678) \84\
and its replacement measure, Changes in Skin Integrity Post-Acute Care:
Pressure Ulcer/Injury Measure more broadly assess the quality of care
furnished by HHAs with respect to skin integrity. These measures
encourage clinicians to assess skin integrity in the prevention of
pressure ulcers, as well as to monitor and promote healing in all HH
patients, not just those with surgical wounds.
---------------------------------------------------------------------------
\84\ To be replaced with a modified version of that measure,
Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury,
beginning with the CY 2020 HH QRP.
---------------------------------------------------------------------------
Therefore, we are proposing to remove the Improvement in the Status
of Surgical Wounds Measure from the HH QRP beginning with the CY 2021
HH QRP under our proposed Factor 4. A more broadly applicable measure
(across settings, populations, or conditions) for the particular topic
is available.
If finalized as proposed, HHAs would no longer be required to
submit OASIS Items M1340, Does this patient have a Surgical Wound? and
M1342, Status of Most Problematic Surgical Wound that is Observable at
the time points of SOC/ROC and Discharge for the purposes of this
measure beginning with January 1, 2020 episodes of care. However, HHAs
would still be required to submit data on Items M1340 and M1342 at the
time point of SOC/ROC as risk adjusters for several other OASIS-based
outcome measures currently adopted for the HH QRP,\85\ and also at the
time point of
[[Page 32445]]
Discharge for the Potentially Avoidable Events measure Discharged to
the Community Needing Wound Care or Medication Assistance \86\ that is
used by HH surveyors during the survey process. If finalized as
proposed, data on this measure would be publicly reported on HH Compare
until January 2021.
---------------------------------------------------------------------------
\85\ The OASIS-based HH QRP outcome measures that use OASIS
Items M1340 and M1342 as a risk adjuster in the calculation of the
measure are: Improvement in Bathing (NQF #0174), Improvement in Bed
Transferring (NQF #0175), Improvement in Ambulation/Locomotion (NQF
#0167), Improvement in Dyspnea, Improvement in Pain Interfering with
Activity (NQF #0177), and Improvement in Management of Oral
Medications (NQF #0176).
\86\ Measure specifications can be found in the Home Health
Potentially Avoidable Events Measures Table on the Home Health
Quality Measures website (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Downloads/Home-Health-PAE-Measures-Table-OASIS-C2_4-11-18.pdf).
---------------------------------------------------------------------------
We are inviting public comment on this proposal.
6. Proposed Removal of the Emergency Department Use Without Hospital
Readmission During the First 30 Days of HH (NQF #2505) Measure
We are proposing to remove the Emergency Department (ED) Use
without Hospital Readmission during the First 30 Days of HH (NQF #2505)
Measure from the HH QRP beginning with the CY 2021 HH QRP, under our
proposed Factor 4. A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic is available).
In the CY 2014 HH PPS final rule (78 FR 72298 through 72301), we
adopted the claims-based ED Use without Hospital Readmission during the
first 30 days of HH (NQF #2505) Measure beginning with CY 2014 HH QRP.
The particular topic for this measure is ED utilization, as it
estimates the risk-standardized rate of ED use without acute care
hospital admission during the 30 days following the start of the HH
stay for patients with an acute inpatient hospitalization in the 5 days
before the start of their HH stay. The ED Use without Hospital
Readmission during the First 30 Days of HH (NQF #2505) Measure is
limited to Medicare FFS patients with a prior, proximal inpatient stay.
Recent analyses from 2016 and 2017 show that this measure annually
captured approximately 2.5 million (25.1 percent in 2016 and 25.1
percent in 2017) of Medicare FFS HH stays and was reportable for less
than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent in
2017).
The ED Use without Hospitalization During the First 60 Days of HH
(NQF #0173) Measure also addresses the topic of ED utilization during a
HH stay. This measure reports the percentage of Medicare FFS HH stays
in which patients used the ED but were not admitted to the hospital
during the 60 days following the start of the HH stay. The ED Use
without Hospitalization during the First 60 days of HH (NQF #0173)
Measure includes Medicare FFS patients irrespective of whether or not
they had an acute inpatient hospitalization in the five days prior to
the start of the HH stay and spans the first 60 days of a HH episode.
Recent analyses using 2016 and 2017 data show this measure annually
captures approximately 8.3 million stays (81.9 percent in 2016 and 81.8
percent in 2017) and is reportable by a greater number of HHAs (88.8
percent in 2016 and 88.1 percent in 2017) than the ED Use without
Hospital Readmission During the First 30 Days of HH (NQF #2505)
Measure.
The ED Use without Hospital Readmission During the First 30 Days of
HH (NQF #2505) Measure addresses outcomes of Medicare FFS patients for
a 30-day interval after the start of their HH care, regardless of the
length of their HH stay. The more broadly applicable ED Use without
Hospitalization during the First 60 days of HH (NQF #0173) Measure
addresses these same outcomes for a greater number of Medicare FFS
patients during the first 60 days of a HH stay and includes the 30-day
interval of the ED Use without Hospital Readmission During the First 30
Days of HH (NQF #2505) Measure. The measure specifications for both
measures are otherwise harmonized along several measure dimensions,
including data source, population, denominator exclusions, numerator,
and risk adjustment methodology. As a result, removing the ED Use
without Hospital Readmission During the First 30 Days of HH (NQF #2505)
Measure in favor of the ED Use without Hospitalization during the First
60 days of HH (NQF #173) Measure will not result in a loss of the
ability to measure the topic of ED utilization for HH patients.
For these reasons, we are proposing to remove the ED Use without
Hospital Readmission During the First 30 Days of HH (NQF #2505) Measure
from the HH QRP beginning with the CY 2021 HH QRP under our proposed
Factor 4. A more broadly applicable measure (across settings,
populations, or conditions) for the particular topic is available. If
finalized as proposed, data for this measure would be reported on HH
Compare until January 2020.
We are inviting public comment on this proposal.
7. Proposed Removal of the Rehospitalization During the First 30 Days
of HH (NQF #2380) Measure
We are proposing to remove the Rehospitalization during the First
30 Days of HH (NQF #2380) Measure from the HH QRP beginning with the CY
2021 HH QRP, under our proposed Factor 4. A more broadly applicable
measure (across settings, populations, or conditions) for the
particular topic is available.
In the CY 2014 HH PPS final rule (78 FR 72297 through 72301), we
adopted the claims-based Rehospitalization during the first 30 Days of
HH Measure beginning with the CY 2014 HH QRP. The measure was NQF-
endorsed (NQF #2380) in December 2014. The Rehospitalization during the
first 30 Days of HH (NQF #2380) Measure addresses the particular topic
of acute care hospital utilization during a HH stay. This measure
estimates the risk-standardized rate of unplanned, all-cause hospital
readmissions for patients who had an acute inpatient hospitalization in
the 5 days before the start of their HH stay and were admitted to an
acute care hospital during the 30 days following the start of the HH
stay (78 FR 72297 through 72301). The Rehospitalization During the
First 30 Days of HH (NQF #2380) Measure only includes Medicare FFS
patients. Recent analyses from 2016 and 2017 show that this measure
annually captured approximately 2.5 million (25.1 percent in 2016 and
25.1 percent in 2017) of Medicare FFS HH stays and was reportable for
less than two-thirds of the HHAs (62.1 percent in 2016 and 62.6 percent
in 2017).
In the CY 2013 HH PPS final rule (77 FR 67093 through 67094), we
finalized the claims-based Acute Care Hospitalization Measure. The
measure's title was later updated to Acute Care Hospitalization During
the First 60 Days of HH (NQF #0171) to improve clarity.\87\ The Acute
Care Hospitalization During the First 60 Days of HH (NQF #0171) Measure
also addresses the topic of acute care hospital utilization during a HH
stay. This measure reports the percentage of HH stays in which Medicare
FFS patients were admitted to an acute care hospital during the 60 days
following the start of the HH stay. The Acute Care Hospitalization
during the First 60 Days of HH (NQF #0171) Measure includes Medicare
FFS patients irrespective of whether or not
[[Page 32446]]
they had an acute inpatient hospitalization in the five days prior to
the start of the HH stay and spans the first 60 days of a HH episode.
Recent analyses using 2016 and 2017 data show this measure annually
captures approximately 8.3 million stays (81.9 percent in 2016 and 81.8
percent in 2017) and is reportable by a greater number of HHAs (88.8
percent in 2016 and 88.1 percent in 2017) than the Rehospitalization
during the First 30 Days of HH (NQF #2380) Measure.
---------------------------------------------------------------------------
\87\ All-Cause Admissions and Readmissions 2015-2017 Technical
Report, National Quality Forum, Washington DC, 2017. (http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=85033) page 20.
---------------------------------------------------------------------------
The Rehospitalization during the First 30 Days of HH (NQF #2380)
Measure addresses outcomes of Medicare FFS patients for a 30-day
interval after the start of their HH care, regardless of the length of
their HH stay. In contrast, the Acute Care Hospitalization During the
First 60 Days of HH (NQF #0171) Measure is broader because it addresses
these same outcomes for a greater number of Medicare FFS patients
during the first 60 Days of a HH stay, which includes the 30-day
interval of the Rehospitalization during the First 30 Days of HH (NQF
#2380) Measure. The measure specifications for both measures are
otherwise harmonized along several measure dimensions, including data
source, population, denominator exclusions, numerator, and risk
adjustment methodology. As a result, removing the Rehospitalization
during the First 30 Days of HH (NQF #2380) Measure in favor of the
Acute Care Hospitalization during the First 60 Days of HH (NQF #0171)
Measure will not result in a loss of the ability to measure the topic
of acute care hospital utilization across the HH setting.
For these reasons, we are proposing to remove the Rehospitalization
during the First 30 Days of HH (NQF #2380) Measure from the HH QRP
beginning with the CY 2021 HH QRP under our proposed Factor 4. A more
broadly applicable measure (across settings, populations, or
conditions) for particular topic is available. If finalized as
proposed, data for this measure would be publicly reported on HH
Compare January 2020.
We are inviting public comment on this proposal.
F. IMPACT Act Implementation Update
In the CY 2018 HH PPS final rule (82 FR 51731), we stated that we
intended to specify two measures that would satisfy the domain of
accurately communicating the existence and provision of the transfer of
health information and care preferences under section 1899B(c)(1)(E) of
the Act no later than January 1, 2019 and intend to propose to adopt
them for the CY 2021 HH QRP, with data collection beginning on or about
January 1, 2020.
As a result of the input provided during a public comment period
between November 10, 2016 and December 11, 2016, input provided by a
technical expert panel (TEP) convened by our contractor, and pilot
measure testing conducted in 2017, we are engaging in continued
development work on these two measures, including supplementary measure
testing and providing the public with an opportunity for comment in
2018. Further, we reconvened a TEP for these measures in April 2018. We
now intend to specify the measures under section 1899B(c)(1)(E) of the
Act no later than January 1, 2020, and intend to propose to adopt the
measures beginning with the CY 2022 HH QRP, with data collection at the
time point of SOC, ROC and Discharge beginning with January 1, 2021.
For more information on the pilot testing, we refer readers to: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
G. Form, Manner, and Timing of OASIS Data Submission
Our home health regulations, codified at Sec. 484.250(a), require
HHAs to submit OASIS assessments and Home Health Care Consumer
Assessment of Healthcare Providers and Systems Survey[supreg] (HHCAHPS)
data to meet the quality reporting requirements of section
1895(b)(3)(B)(v) of the Act. We are proposing to revise Sec.
484.250(a) to clarify that not all OASIS data described in Sec.
484.55(b) and (d) are needed for purposes of complying with the
requirements of the HH QRP. OASIS data items may be submitted for other
established purposes unrelated to the HH QRP, including payment,
survey, the HH VBP Model, or care planning. Any OASIS data that are not
submitted for the purposes of the HH QRP are not used for purposes of
HH QRP compliance.
We are inviting public comment on our proposal to revise our
regulations at Sec. 484.250(a) to clarify that not all OASIS data
described in Sec. 484.55(b) and (d) are needed for purposes of
complying with the requirements of the HH QRP.
H. Proposed Policies Regarding Public Display for the HH QRP
Section 1899B(g) of the Act requires that data and information of
PAC provider performance on quality measures and resource use and other
measures be made publicly available beginning not later than 2 years
after the applicable specified `application date'. In the CY 2018 HH
PPS final rule (82 FR 51740 through 51741), we finalized that we would
publicly display the Medicare Spending Per Beneficiary (MSPB)-PAC HH
QRP beginning in CY 2019 based on one year of claims data on discharges
from CY 2017.
In this proposed rule, we are proposing to increase the number of
years of data used to calculate the MSPB-PAC HH QRP for purposes of
display from 1 year to 2 years. Under this proposal, data on this
measure would be publicly reported in CY 2019, or as soon thereafter as
operationally feasible, based on discharges from CY 2016 and CY 2017.
Increasing the measure calculation and public display periods from 1 to
2 years of data increases the number of HHAs with enough data adequate
for public reporting for the MSPB-PAC HH QRP measure from 90.7 percent
(based on August 1st, 2014--July 31st, 2015 Medicare FFS claims data)
to 94.9 percent (based on August 1st, 2014--July 31st, 2016 Medicare
FFS claims data). Increasing measure public display periods to 2 years
also aligns with the public display periods of these measures in the
IRF QRP, LTCH QRP and SNF QRP.
We invite public comment on our proposal to increase the number of
years of data used to calculate the MSPB-PAC HH QRP for purposes of
display from 1 year to 2 years.
I. Home Health Care Consumer Assessment of Healthcare Providers and
Systems[supreg] (HHCAHPS)
We are not proposing changes to the Home Health Care Consumer
Assessment of Healthcare Providers and Systems[supreg] (HHCAHPS) Survey
requirements for CY 2019. Therefore, HHCAHPS Survey requirements are as
codified in Sec. 484.250 and the HHCAHPS survey vendors' data
submission deadlines are as posted on HHCAHPS website at https://homehealthcahps.org.
VI. Medicare Coverage of Home Infusion Therapy Services
In this section of the rule, we discuss the new home infusion
therapy benefit that was established in section 5012 of the 21st
Century Cures Act. This benefit covers the nursing, patient training
and education, and monitoring services associated with administering
infusion drugs in a patient's home. This proposed rule would establish
health and safety standards for home infusion therapy and consistency
in coverage for home infusion therapy services. Section
1861(iii)(3)(D)(III) of the Act, as added
[[Page 32447]]
by section 5012(b) of the 21st Cures Act, requires that a qualified
home infusion therapy supplier be accredited by an accrediting
organization (AO) designated by the Secretary in accordance with
section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of the Act
identifies factors for designating AOs and modifying the list of
designated AOs. Section 1834(u)(5)(B) of the Act requires the Secretary
to designate AOs to accredit home infusion therapy suppliers furnishing
home infusion therapy not later than January 1, 2021. In addition, this
proposed rule establishes regulations for the approval and oversight of
accrediting organizations that provide accreditation to home infusion
therapy suppliers. This rule also provides information on temporary
transitional payments for home infusion therapy services for CYs 2019
and 2020, as mandated by section 50401 of the BBA of 2018, proposes a
regulatory definition of ``Infusion Drug Administration Calendar Day'',
and solicits comments regarding payment for home infusion therapy
services for CY 2021 and subsequent years as required by section
5012(d) of the 21st Century Cures Act.
A. General Background
1. Overview
Infusion drugs and administration services can be provided in
multiple health care settings, including inpatient hospitals, skilled
nursing facilities (SNFs), hospital outpatient departments (HOPDs),
physician offices, and in the home. Traditional Fee-for-Service (FFS)
Medicare provides coverage for infusion drugs, equipment, supplies, and
administration services. However, Medicare coverage requirements and
payment vary for each of these settings. Infusion drugs, equipment,
supplies, and administration are all covered by Medicare in the
inpatient hospital, SNFs, HOPDs, and physician's offices. Generally,
Medicare payment under Part A for the drugs, equipment, supplies, and
services are bundled, meaning a single payment is made on the basis of
expected costs for clinically-defined episodes of care. For example, if
a beneficiary is receiving an infusion drug during an inpatient
hospital stay, the Part A payment for the drug, supplies, equipment,
and drug administration is included in the diagnosis-related group
(DRG) payment to the hospital under the Medicare inpatient prospective
payment system. Beneficiaries are liable for the Medicare inpatient
hospital deductible. Similarly, if a beneficiary is receiving an
infusion drug while in a SNF under a Part A stay, the payment for the
drug, supplies, equipment, and drug administration are included in the
SNF prospective payment system payment. After 20 days of SNF care,
there is a daily beneficiary cost-sharing amount through day 100 when
the beneficiary becomes responsible for all costs for each day after
day 100 of the benefit period. Under Medicare Part B, certain items and
services are paid separately while other items and services may be
packaged into a single payment together. For example, in an HOPD and in
a physician's office, the drug is paid separately, generally at the
average sales price (ASP) plus 6 percent. There is also a separate
payment for drug administration in which the payment for infusion
supplies and equipment is packaged in the payment for administration.
The separate payment for infusion drug administration in an HOPD and in
a physician's office generally includes a base payment amount for the
first hour and a payment add-on that is a different amount for each
additional hour of administration. The beneficiary is responsible for
the 20 percent coinsurance under Medicare Part B. Medicare FFS covers
outpatient infusion drugs under Part B, ``incident to'' a physician's
services, provided the drugs are not usually self- administered by the
patient. Drugs that are ``not usually self-administered,'' are defined
in our manual according to how the Medicare population as a whole uses
the drug, not how an individual patient or physician may choose to use
a particular drug. For the purpose of this exclusion, the term
``usually'' means more than 50 percent of the time for all Medicare
beneficiaries who use the drug. The term ``by the patient'' means
Medicare beneficiaries as a collective whole. Therefore, if a drug is
self-administered by more than 50 percent of Medicare beneficiaries,
the drug is excluded from Part B coverage. This determination is made
on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis.\88\
The MACs update Self-Administered Drug (SAD) exclusion lists on a
quarterly basis.\89\
---------------------------------------------------------------------------
\88\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.
\89\ www.cms.gov/medicare-coverage-database/reports/sad-exclusion-list-report.aspx?bc=AQAAAAAAAAAAAA%3D%3D.
---------------------------------------------------------------------------
Home infusion therapy involves the intravenous or subcutaneous
administration of drugs or biologicals to an individual at home.
Certain drugs can be infused in the home, but the nature of the home
setting presents different challenges than the settings previously
described. The components needed to perform home infusion include the
drug (for example, antibiotics, immune globulin), equipment (for
example, a pump), and supplies (for example, tubing and catheters).
Likewise, nursing services are necessary to train and educate the
patient and caregivers on the safe administration of infusion drugs in
the home. Visiting nurses often play a large role in home infusion.
Nurses typically train the patient or caregiver to self-administer the
drug, educate on side effects and goals of therapy, and visit
periodically to provide catheter and site care. Depending on patient
acuity or the complexity of the drug administration, certain infusions
may require more nursing time, especially those that require special
handling or pre-or post-infusion protocols. The home infusion process
typically requires coordination among multiple entities, including
patients, physicians, hospital discharge planners, health plans, home
infusion pharmacies, and, if applicable, home health agencies. With
regard to payment for home infusion therapy under traditional Medicare,
drugs are generally covered under Part B or Part D. Certain infusion
pumps, supplies (including home infusion drugs), and nursing are
covered in some circumstances through the Part B durable medical
equipment (DME) benefit, the Medicare home health benefit, or some
combination of these benefits.
Medicare Part B covers a limited number of home infusion drugs
through the DME benefit if: (1) The drug is necessary for the effective
use of an external or implantable infusion pump classified as DME and
determined to be reasonable and necessary for administration of the
drug; and (2) the drug being used with the pump is itself reasonable
and necessary for the treatment of an illness or injury. Only certain
types of infusion pumps are covered under the DME benefit. The Medicare
National Coverage Determinations Manual, chapter 1, part 4, Sec. 280.1
describes the types of infusion pumps that are covered under the DME
benefit.\90\ For DME infusion pumps, Medicare Part B covers the
infusion drugs and other supplies and services necessary for the
effective use of the pump, but does not explicitly require or pay
separately for any associated home infusion nursing services beyond
what is necessary for teaching the patient and/or caregiver on how to
operate the equipment in order to administer the
[[Page 32448]]
infusion safely and effectively.\91\ Through local coverage policies,
the DME Medicare administrative contractors (MACs) specify the details
of which infusion drugs are covered with these pumps. Examples of
covered Part B DME infusion drugs include, among others, certain IV
drugs for heart failure and pulmonary arterial hypertension, immune
globulin for primary immune deficiency (PID), insulin, antifungals,
antivirals, and chemotherapy, in limited circumstances.
---------------------------------------------------------------------------
\90\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.html.
\91\ See 42 CFR 424.57(c)(12), which states that the DME
``supplier must document that it or another qualified party has at
an appropriate time, provided beneficiaries with necessary
information and instructions on how to use Medicare-covered items
safely and effectively.''
---------------------------------------------------------------------------
2. Home Infusion Therapy Legislation
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255) (Cures
Act) creates a separate Medicare Part B benefit category under
1861(s)(2)(GG) of the Act for coverage of home infusion therapy-
associated professional services for certain drugs and biologicals
administered intravenously, or subcutaneously through a pump that is an
item of DME, effective January 1, 2021. The infusion pump and supplies
(including home infusion drugs) will continue to be covered under the
DME benefit. Section 1861(iii)(2) of the Act defines home infusion
therapy to include the following items and services: the professional
services (including nursing services), furnished in accordance with the
plan, training and education (not otherwise included in the payment for
the DME), remote monitoring, and other monitoring services for the
provision of home infusion therapy furnished by a qualified home
infusion therapy supplier in the patient's home. Section
1861(iii)(3)(B) of the Act defines the patient's home to mean a place
of residence used as the home of an individual as defined for purposes
of section 1861(n) of the Act. As outlined in section 1861(iii)(1) of
the Act, i to be eligible to receive home infusion therapy services
under the home infusion therapy benefit, the patient must be under the
care of an applicable provider, defined in section 1861(iii)(3)(A) of
the Act as a physician, nurse practitioner, or physician's assistant,
and the patient must be under a physician-established plan of care that
prescribes the type, amount, and duration of infusion therapy services
that are to be furnished. The plan of care must be periodically
reviewed by the physician in coordination with the furnishing of home
infusion drugs (as defined in section 1861(iii)(3)(C) of the Act).
Section 1861(iii)(3)(C) of the Act defines a ``home infusion drug''
under the home infusion therapy benefit as a drug or biological
administered intravenously, or subcutaneously for an administration
period of 15 minutes or more, in the patient's home, through a pump
that is an item of DME as defined under section 1861(n) of the Act.
This definition does not include insulin pump systems or any self-
administered drug or biological on a self-administered drug exclusion
list.
Section 1861(iii)(3)(D)(i) of the Act defines a qualified home
infusion therapy supplier as a pharmacy, physician, or other provider
of services or supplier licensed by the state in which supplies or
services are provided. The provision specifies qualified home infusion
therapy suppliers must furnish infusion therapy to individuals with
acute or chronic conditions requiring administration of home infusion
drugs; ensure the safe and effective provision and administration of
home infusion therapy on a 7-day-a-week, 24-hour-a-day basis; be
accredited by an organization designated by the Secretary; and meet
other such requirements as the Secretary deems appropriate, taking into
account the standards of care for home infusion therapy established by
Medicare Advantage plans under part C and in the private sector. The
supplier may subcontract with a pharmacy, physician, other qualified
supplier or provider of medical services, in order to meet these
requirements.
Section 1834(u) of the Act requires the Secretary to implement a
payment system under which a single payment is made to a home infusion
therapy supplier for the items and services (professional services,
including nursing services; training and education; remote monitoring,
and other monitoring services), beginning January 1, 2021. The single
payment must take into account, as appropriate, types of infusion
therapy, including variations in utilization of services by therapy
type. In addition, the single payment amount is required to be adjusted
to reflect geographic wage index and other costs that may vary by
region, patient acuity, and complexity of drug administration. The
single payment may be adjusted to reflect outlier situations, and other
factors as deemed appropriate by the Secretary, which are required to
be done in a budget neutral manner. Section 1834(u)(3) of the Act
specifies that annual updates to the single payment are required to be
made beginning January 1, 2022, by increasing the single payment amount
by the percent increase in the Consumer Price Index (CPI) for all urban
consumers for the 12-month period ending with June of the preceding
year, reduced by the multi-factor productivity adjustment. The unit of
single payment for each infusion drug administration calendar day,
including the required adjustments and the annual update, cannot exceed
the amount determined under the fee schedule under section 1848 of the
Act for infusion therapy services if furnished in a physician's office,
and the single payment amount cannot reflect more than 5 hours of
infusion for a particular therapy per calendar day. Section 1834(u)(4)
of the Act also allows the Secretary discretion, as appropriate, to
consider prior authorization requirements for home infusion therapy
services. Finally, section 5012(c)(3) of the Cures Act amended section
1861(m) of the Act to exclude home infusion therapy from the HH PPS
beginning on January 1, 2021.
B. Proposed Health and Safety Standards for Home Infusion Therapy
1. Introduction
Section 5012 of the Cures Act requires that, to receive payment
under the Medicare home infusion therapy benefit, home infusion therapy
suppliers must select a CMS-approved accreditation organization (AO)
and undergo an accreditation review process to demonstrate that the
home infusion therapy supplier meets the AO's standards. Section
1861(iii) of the Act, as added by section 5012 of the Cures Act, sets
forth four elements for home infusion therapy in the following areas:
(1) Requiring that the patient be under the care of a physician, nurse
practitioner, or physician assistant; (2) requiring that all patients
have a plan of care established and updated by a physician that sets
out the care and prescribed infusion therapy necessary to meet the
patient specific needs; (3) providing patients with education and
training on the effective use of medications and equipment in the home
(not otherwise paid for as durable medical equipment); and (4)
providing monitoring and remote monitoring services associated with
administering infusion drugs in a patient's home.
The Journal of Infusion Nursing standards of practice specifically
address patient education, and state that it is the clinician's role to
educate the patient, caregiver, and/or surrogate about the prescribed
infusion therapy and plan of care including, but not limited to,
purpose and expected outcome(s) and/or goals of treatment, infusion
therapy administration; infusion device-related care; potential
[[Page 32449]]
complications; or adverse effects associated with treatment. (Infusion
Therapy Standards of Practice, 2015).\92\
---------------------------------------------------------------------------
\92\ Infusion Therapy: Standards of Practice, Journal of
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26
---------------------------------------------------------------------------
Currently, standards for home infusion therapy have been
established by the current AOs; however, they are not necessarily
consistent. In order to assure consistency in the areas identified in
the Act, we are establishing basic standards that all AOs would be
required to meet or exceed. We are proposing universal standards for
Medicare-participating qualified home infusion therapy suppliers to
ensure the quality and safety of home infusion therapy services for all
beneficiaries that these suppliers serve.
In preparation for developing these standards and to gain a clear
understanding of the current home infusion therapy supplier private
sector climate, we reviewed the requirements established by section
5012 of the Cures Act, performed an extensive review of the standards
from all six AOs that accredit home infusion suppliers (The Joint
Commission, Accreditation Commission for Health Care, Compliance Team,
Community Health Accreditation Partner, Healthcare Quality Association
on Accreditation, and National Association of Boards of Pharmacy), and
reviewed various other government and industry publications listed in
this proposed rule. In addition to the standards, we reviewed the
following documents related to coverage:
Government Accountability Office--10-426 report, which
describes the state of coverage of home infusion therapy components
under Medicare fee-for-service prior to the enactment of the Cures Act
(GAO, 2010).\93\
---------------------------------------------------------------------------
\93\ Government Accountability Office. (2010). Home Infusion
Therapy. Differences between Medicare and Private Insurers'
coverage. (GAO Publication No. 10-426). Washington, DC: U.S.
Government Printing Office.
---------------------------------------------------------------------------
Medicare and Home Infusion white paper written by the
National Home Infusion Association (NHIA), which provided an overview
of Medicare coverage provided for Home Infusion Therapy services prior
to the enactment of the Cures Act, as well as results of a study
conducted by Avalere Health on the potential savings that could result
from Medicare coverage of infusion therapy provided in the home
(National Home Infusion Therapy Association, NDS).\94\
---------------------------------------------------------------------------
\94\ National Home Infusion therapy Association. Medicare and
Home Infusion White Paper. Retrieved from https://www.nhia.org/resource/legislative/documents/NHIAWhitePaper-Web.pdf.
---------------------------------------------------------------------------
American Society of Health System Pharmacists Guidelines
on Home Infusion Pharmacy Services, which provided an in-depth overview
of specialized, complex. pharmaceuticals, best practices on providing
home infusion therapy in the home or alternative site settings, and the
plans to execute and manage the therapy (American Society of Health-
System Pharmacists. ASHP guidelines on Home Infusion Pharmacy Service,
2014).\95\
---------------------------------------------------------------------------
\95\ American Society of Health-System Pharmacists. ASHP
guidelines on Home Infusion Pharmacy Service, 2014. Retrieved from:
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/home-infusion-pharmacy-services.ashx?la=en&hash=255092A51D0AE4746C151C51AC7BF82217AC2F76.
---------------------------------------------------------------------------
The requirements of numerous Medicare Advantage plans,
Medicare FFS, and private insurance plans.
Upon review of these materials, we believe that there is a
sufficient private-sector framework already in place to address many of
the areas that would typically be included in the establishment of
basic health and safety standards for home infusion therapy. For
example, existing AO standards include requirements related to plan of
care, monitoring, patient assessment, quality improvement, and
infection control. While the exact content of the AO standards vary, we
believe that the standards are adequate to ensure patient health and
safety. The AO representing the largest number of home infusion therapy
suppliers requires that home infusion pharmacies provide certain
services to ensure safe and appropriate therapy, in compliance with
nationally recognized standards of practice. Patient training and
education activities, as part of their required admission procedures,
include the use of medical and disposable equipment, medication
storage, emergency procedures, vascular access device management,
recognition of a drug reaction, and when to report any adverse drug
event. As such, we conclude that it is appropriate at this time to
propose requirements for only those elements specifically identified in
section 1861(iii) of the Act. Through the CMS accreditation
organization process, we would monitor home infusion therapy suppliers
to assure that services are provided in a safe and effective manner,
and would consider future rulemaking to address any areas that may need
improvement in the future. We are seeking public comment on this
approach and invite comments related to the home infusion therapy
proposed standards. Specifically, are the standards sufficient for
Medicare beneficiaries, should CMS consider additional standards and
would additional standards impose additional burden?
2. Home Infusion Therapy Supplier Requirements (Proposed Part 486,
Subpart I)
We propose to add a new 42 CFR part 486, subpart I, to incorporate
the home infusion therapy supplier requirements. The proposed
regulations would provide a framework for CMS to approve home infusion
therapy accreditation organizations and give them the authority to
approve Medicare certification for home infusion therapy suppliers.
Proposed subpart I would include General Provisions (Basis and Scope,
and Definitions) and Standards for Home Infusion Therapy (Plan of Care
and Required Services).
a. Basis and Scope (Proposed Sec. 486.500)
We propose to set forth the basis and scope of part 486 at Sec.
486.500. Part 486 is based on sections 1861(iii)(2)(D) of the Act,
which establishes the requirements that a home infusion therapy
supplier must meet in order to participate in the Medicare program.
These provisions serve as the basis for survey activities for the
purposes of determining whether a home infusion therapy supplier meets
the requirements for participation in Medicare. Section 1834(u) of the
Act serves as the basis for the establishment of a prospective payment
system for home infusion therapy covered under Medicare. In addition,
1834(u)(5) of the Act establishes the factors for the Secretary to
designate organizations to accredit suppliers furnishing home infusion
therapy and requires that organizations be designated not later than
January 1, 2021.
b. Definitions (Proposed Sec. 486.505)
At Sec. 486.505, we propose to define certain terms that would be
used in the home infusion therapy requirements. We propose to define
the terms ``applicable provider'', ``home'', ``home infusion drug'',
and ``qualified home infusion therapy supplier'' in accordance with the
definitions set forth in section 1861(iii) of the Act. Furthermore,
section 1861(iii) of the Act includes a definition of the term ``home
infusion therapy'' that is the basis of the proposed health and safety
requirements set forth in this rule. In accordance with the Act, we
propose the following definitions:
``Applicable provider'' would mean a physician, a nurse
practitioner, and a physician assistant.
``Home'' would mean a place of residence used as the home
of an individual, including an institution that
[[Page 32450]]
is used as a home. However, an institution that is used as a home may
not be a hospital, CAH, or SNF as defined in sections 1861(e),
1861(mm)(1), and 1819 of the Act, respectively.
``Home infusion drug'' would mean a parenteral drug or
biological administered intravenously, or subcutaneously for an
administration period of 15 minutes or more, in the home of an
individual through a pump that is an item of durable medical equipment.
The term does not include insulin pump systems or a self-administered
drug or biological on a self-administered drug exclusion list.
``Qualified home infusion therapy supplier'' would mean a
supplier of home infusion therapy that meets the all of the following
criteria which are set forth at section 1861(iii)(3)(D)(i) of the Act:
(1) Furnishes infusion therapy to individuals with acute or chronic
conditions requiring administration of home infusion drugs; (2) ensures
the safe and effective provision and administration of home infusion
therapy on a 7-day-a-week, 24-hour-a-day basis; (3) is accredited by an
organization designated by the Secretary in accordance with section
1834(u)(5) of the Act; and (4) meets such other requirements as the
Secretary determines appropriate.
c. Standards for Home Infusion Therapy
Proposed subpart I, as required by section 5012 of the Cures Act,
would specify that the qualified home infusion therapy supplier ensure
that all patients have a plan of care established by a physician.
(1) Plan of Care (Proposed Sec. 486.520)
At Sec. 486.520(a), we propose to require that all patients must
be under the care of an ``applicable provider'' as defined at Sec.
486.505. At Sec. 486.520(b) we would require that the qualified home
infusion therapy supplier ensure that all patients must have a plan of
care established by a physician that prescribes the type, amount, and
duration of home infusion therapy services that are furnished. The plan
of care would also include the specific medication, the prescribed
dosage and frequency as well as the professional services to be
utilized for treatment. In addition, the plan of care would specify the
care and services necessary to meet the patient-specific needs.
We also propose, at Sec. 486.520(c), that the qualified home
infusion therapy supplier must ensure that the plan of care for each
patient is periodically reviewed by the physician. We do not propose to
establish a specific time frame for review requirements, but the
expectation is that the physician is active in the patient's care and
can make appropriate decisions related to the course of therapy if
changes are necessary in regards to the progress of the patient and
goal achievement with the infusion therapy. We welcome comments
regarding the proposed home infusion therapy plan of care requirements
and if we should include specific review timeframes for the plan of
care.
(2) Required Services (Proposed Sec. 486.525)
Section 1861(iii)(2)(D)(II) of the Act specifically mandates that
qualified home infusion therapy suppliers ensure the safe and effective
provision and administration of home infusion therapy on a 7-day-a-
week, 24-hour-a-day basis. Infusion drugs are administered directly
into a vein or under the skin, eliciting a more rapid clinical response
than with oral medications. Consequently, an adverse effect or a
medication error could result in a quicker and/or more severe
complication. Therefore, at Sec. 486.525(a), we propose to require the
provision of professional services, including nursing services,
furnished in accordance with the plan of care. We propose to require
that home infusion therapy suppliers ensure that professional services
are available on a 7-day-a-week, 24-hour-a-day basis in order to ensure
that patients have access to expert clinical knowledge and advice in
the event of an urgent or emergent infusion-related situation. This
proposed requirement is imperative, as the success of home infusion
therapy is often dependent upon the professional services being
available during all hours and days of the week that allows for the
patient to safely and effectively manage all aspects of treatment.
At Sec. 486.525(b), we propose to require patient training and
education, not otherwise paid for as durable medical equipment, and as
described in 42 CFR 424.57(c)(12). This proposed requirement is
consistent with section 1861(iii)(2)(B). In addition, the proposed
patient training and education requirements are consistent with
standards that are already in place, as established by the current AOs
of home infusion therapy suppliers. This is a best practice, as home
infusion therapy may entail the use of equipment and supplies with
which patients' may not be comfortable or familiar.
At Sec. 486.525(c), we propose to require qualified home infusion
therapy suppliers to provide remote monitoring and monitoring services
for the provision of home infusion therapy services and home infusion
drugs furnished by a qualified home infusion therapy supplier. This
proposed requirement is also consistent with section 1861(iii)(2)(B).
Monitoring the patient receiving infusion therapy in their home is a
vital standard of practice that is an integral part of providing
medical care to patients in their home.\96\ The expectation is that
home infusion therapy suppliers would provide ongoing patient
monitoring and continual reassessment of the patient to evaluate
response to treatment, drug complications, adverse reactions, and
patient compliance. Remote monitoring may be completed through follow-
up telephone or other electronic communication, based on patient
preference of communication. However, we do not propose to limit remote
monitoring to these methods. Suppliers would be permitted to use all
available remote monitoring methods that are safe and appropriate for
their patients and clinicians and as specified in the plan of care as
long as adequate security and privacy protections are utilized.
Monitoring may also be performed directly during in-home patient
visits. Additional discussion on remote monitoring and monitoring
services can be found in section II.C.2.d. of this proposed rule. We
invite the public to submit comments regarding the proposed home
infusion therapy supplier service requirements.
---------------------------------------------------------------------------
\96\ Infusion Therapy: Standards of Practice, Journal of
Infusion Nursing, Wolters Kluwer: Jan/Feb 2016 pp S25-S26.
---------------------------------------------------------------------------
C. Approval and Oversight of Accrediting Organizations for Home
Infusion Therapy Suppliers
1. Background
Section 1861(iii)(3)(D)(III) of the Social Security Act (the Act),
as added by section 5012(b) of the Cures Act, requires that a home
infusion therapy supplier be accredited by an AO designated by the
Secretary in accordance with section 1834 (u)(5) of the Act. Section
1834(u)(5)(A) of the Act identifies factors for designating AOs and
modifying the list of designated AOs. These statutory factors are: (1)
The ability of the organization to conduct timely reviews of
accreditation applications; (2) the ability of the organization take
into account the capacities of suppliers located in a rural area (as
defined in section 1886(d)(2)(D) of the Act); (3) whether the
organization has established reasonable fees to be charged to suppliers
applying for accreditation; and, (4) such other factors as the
Secretary determines appropriate.
[[Page 32451]]
Section 1834(u)(5)(B) of the Act requires the Secretary to
designate AOs to accredit home infusion therapy suppliers furnishing
home infusion therapy not later than January 1, 2021. However, at this
time, there are six AOs that are providing accreditation to home
infusion therapy suppliers. These AOs are: (1) The Joint Commission
(TJC); (2) Accreditation Commission for Health Care (ACHC); (3)
Compliance Team (TCT); (4) Community Health Accreditation Partner
(CHAP); (5) Healthcare Quality Association on Accreditation; and (6)
National Association of Boards of Pharmacy. These AOs are accrediting
home infusion therapy suppliers as part of the deeming accreditation of
home health agencies. However, these AOs have not been separately
approved by Medicare for accreditation of home infusion therapy
services.
We are proposing to publish a solicitation notice in the Federal
Register, in which we would invite national AOs to apply to accredit
home infusion therapy suppliers for the Medicare program. We are
proposing that this solicitation notice would be published after the
final rule is published, so that we can designate AOs to accredit home
infusion therapy suppliers by no later than January 1, 2021 as required
by 1834(u)(5)(B) of the Act. Any AOs that respond to this solicitation
notice would be required to submit an application for CMS-approval of
their home infusion therapy accreditation program. The application
submitted by an AO that respond to the solicitation notice would be
required to meet all requirements set forth in proposed Sec. 488.1010
and demonstrate that their substantive requirements are equal to or
more stringent than our proposed regulations at part 485, subpart I.
Section 1861(iii)(3)(D) of the Act requires ``qualified home
infusion therapy suppliers'' to be accredited by a CMS-approved AO. We
are also proposing that, in order for the home infusion therapy
suppliers accredited by the six AOs that currently provide non-Medicare
approved home infusion therapy accreditation to continue receiving
payment for the home infusion therapy services they provide, the 6
existing AOs must submit applications to CMS for Medicare approval of
their home infusion therapy accreditation program. The accreditation
currently being provided by these six AOs to the home infusion therapy
suppliers is part of another accreditation program that has not be
separately approved by CMS. These AOs have not submitted an application
to CMS for approval of a specific home infusion therapy accreditation
program that meets the requirements of section 1861(iii) and section
1834(u)(5) of the Act; therefore, CMS has not been able to determine
whether the home infusion therapy accreditation program standards used
by these AOs meets or exceeds those of Medicare.
We are proposing that the home infusion therapy accreditation
program submitted to CMS by these existing AOs be a separate and
distinct accreditation program from the AO's home health accreditation
program. This would mean that these AOs must have a separate
accreditation program with separate survey processes and standards for
the accreditation of home infusion therapy suppliers. In addition, we
would require that the application submitted by the six AOs that
currently provide non-Medicare approved accreditation to home infusion
therapy suppliers meet the requirements set forth in the proposed
regulations at Sec. 488.1010 and enforce the substantive health and
safety standards proposed to be set out at 42 CFR part 485, subpart I.
Section 1834(u)(5)(C)(ii) of the Act states that in the case where
the Secretary removes a home infusion therapy AO from the list of
designated home infusion therapy AOs, any home infusion therapy
supplier that is accredited by the home infusion therapy AO during the
period beginning on the date on which the home infusion therapy AO is
designated as an CMS-approved home infusion therapy AO and ending on
the date on which the home infusion therapy AO is removed from such
list, shall be considered to have been accredited by an home infusion
therapy AO designated by the Secretary for the remaining period such
accreditation is in effect. Under section 1834(u)(5)(D) of the Act, in
the case of a home infusion therapy supplier that is accredited before
January 1, 2021 by a home infusion therapy AO designated by the
Secretary as of January 1, 2019, such home infusion therapy supplier
shall be considered to be accredited by a home infusion therapy AO
designated by the Secretary as of January 1, 2023, for the remaining
period such accreditation is in effect. Home infusion therapy suppliers
are required to receive accreditation before receiving Medicare payment
for services provided to Medicare beneficiaries.
Section 1861(iii)(3)(D) of the Act defines ``qualified home
infusion therapy suppliers'' as being accredited by a CMS-approved AO.
CMS is proposing to establish regulations for the approval and
oversight of AOs that accredit home infusion therapy suppliers that
address the following: (1) The required components to be included in a
home infusion therapy AO's initial or renewal application for CMS
approval of the AO's home infusion therapy accreditation program; (2)
the procedure for CMS' review and approval of the home infusion therapy
AOs application for CMS approval of its home infusion therapy
accreditation program; and (3) the ongoing monitoring and oversight of
CMS-approved home infusion therapy AOs.
2. Proposed Process and Standards for Home Infusion Therapy
Accreditation and the Approval and Oversight of Accrediting
Organizations With CMS-Approved Accreditation Programs for Home
Infusion Therapy Services
a. Establishment of Regulatory Requirements
We propose to establish new regulations in a new subpart L in 42
CFR part 488 that would govern CMS' approval and oversight of AOs that
accredit home infusion therapy suppliers. We believe these proposed new
regulations would provide CMS with reasonable assurance that the home
infusion therapy AO's accreditation program requirements are consistent
with the appropriate Medicare accreditation program requirements.
Further, we believe that these proposed regulations would provide CMS
with a way to provide oversight for AOs that accredit home infusion
therapy suppliers, and provide CMS with authority over the home
infusion therapy suppliers.
We are proposing to implement a comprehensive, consistent and
standardized set of AO oversight regulations for accreditors of home
infusion therapy suppliers. It is our intention to provide home
infusion therapy AOs with the flexibility to innovate within the
framework of these proposed regulations while assuring that their
accreditation standards meet, or exceed the appropriate Medicare
requirements, and their survey processes are comparable to those of
Medicare. ``Flexibility to innovate'' means that AOs retain the freedom
to develop their own accreditation standards and survey processes, so
long as the AO ensures that they meet the proposed health and safety
standards (contained in 42 CFR part 486, subpart B) and the AO meets
the requirements of the proposed AO approval and oversight regulations.
The proposed regulations would reflect requirements similar to
those in place for the oversight of national AOs
[[Page 32452]]
for Medicare-certified providers and suppliers which are codified at 42
CFR 488.1 through 488.9 and 42 CFR part 489, but would be modified, as
appropriate, to be applicable for accreditors of home infusion therapy
suppliers. We believe that it is important to have AO approval and
oversight regulations that are as consistent as possible across all AOs
and to treat all AOs in a similar manner.
b. Consideration of Existing Regulations
In formulating our approach to implementing the statutory
requirements related to accreditation organizations, we had considered
using the regulations at 42 CFR 488.1 to 488.13 for the approval and
oversight of AOs that accredit home infusion therapy suppliers.
However, we decided not to do so because Congress, by setting out
separate accreditation organization approval standards for home
infusion therapy suppliers at 1834(u)(5)(A) of the Act, intended
approval for this accreditation program to be a discrete process. We
believe that having a separate set of approval regulations applicable
only to home infusion therapy suppliers will best reflect Congress's
intent.
Only limited portions of the regulations at Sec. Sec. 488.1
through 488.13 would apply to AOs that accredit home infusion therapy
suppliers. For example, Sec. 488.6, which provides that a supplier or
provider that has been granted ``deemed status'' by CMS by virtue of
its accreditation from a CMS-approved accreditation program is eligible
to participate in the Medicaid program if they are not required under
Medicaid regulations to comply with any requirements other than
Medicare participation requirements would not apply to home infusion
therapy suppliers because home infusion therapy suppliers cannot be
deemed. The deeming process only applies to certain types of Medicare
certified providers and suppliers, such as hospitals.
Section 488.7 titled ``Release and use of accreditation surveys''
and Sec. 488.8 titled ``Ongoing review of accrediting organizations''
would apply to AOs that accredit home infusion therapy suppliers.
However, Sec. 488.9 titled ``Validation surveys'' would not apply to
home infusion therapy suppliers because the State Survey Agency (SA)
only performs validation surveys for Medicare providers that have an
agreement with Medicare. Home infusion therapy suppliers are enrolled
in the Medicare program but do not enter into an agreement with
Medicare, therefore the SA will not perform validation surveys of home
infusion therapy suppliers. Also, section 1864(a) of the Act provides,
that by agreement with the Secretary, the SA shall provide services to
the following Medicare certified healthcare providers: Hospitals,
skilled nursing facilities, home health agencies, hospice programs,
rural health clinics, critical access hospitals, comprehensive
outpatient rehabilitation facilities, laboratories, clinics,
rehabilitation agencies, public health agencies, or ambulatory surgical
centers.
Section 488.10, titled ``State survey agency review: Statutory
provisions'', Sec. 488.11 titled ``State survey agency functions'' and
Sec. 488.12 titled ``Effect of survey agency certification'' would
also not apply to home infusion therapy AOs. This is because, as stated
previously, the SA does not perform validation surveys for AOs that
accredit home infusion therapy providers. Section 488.13, titled ``Loss
of accreditation'' provides that ``if an accrediting organization
notifies CMS that it is terminating a provider or supplier due to non-
compliance with its CMS-approved accreditation requirements, the SA
will conduct a full review in a timely manner.'' This section would
also not apply to AOs that accredit home infusion therapy suppliers
because this regulation section requires use of the SA.
Section 488.14 titled, ``Effect of QIO review'' provides that
``when a QIO is conducting review activities under section 1154 of the
Act and part 466 of this chapter, its activities are in lieu of the
utilization review and evaluation activities required of health care
institutions under sections 1861(e)(6), and 1861(k) of the Act.'' This
section would not apply to home infusion therapy suppliers because it
is only applicable only to hospitals.
Finally, Sec. 488.18, titled ``Documentation of findings'' states
that ``the findings of the State agency with respect to each of the
conditions of participation, requirements (for SNFs and NFs), or
conditions for coverage must be adequately documented.'' This section
would not apply to AOs that accredit home infusion therapy suppliers
because it involves the finding of the SA related only to SNFs and NFs.
In conclusion, a majority of sections contained in Sec. Sec. 488.1
through 488.13 do not apply to home infusion therapy AOs and home
infusion therapy suppliers. Therefore, we are proposing to create a
separate set of regulations that are specifically applicable to home
infusion therapy AOs and suppliers.
We seek comment on our decision not to use the existing regulation
at Sec. Sec. 488.1 through 488.13.
c. Consideration of a Validation Process for Accrediting Organizations
That Accredit Home Infusion Therapy Suppliers
Our conventional validation process involves the participation of
the CMS Regional Offices (ROs) to request the State Survey Agency to
conduct an onsite validation (follow-up) survey within 60 days of an
AO's onsite survey. The purpose of a validation survey is to evaluate
the ability of that AO's survey process to identify serious, condition
level deficiencies.
We are not proposing to establish a validation program requirement
for home infusion therapy AOs and suppliers due to a number of resource
constraints. Several factors limit our ability to establish and
implement a validation program for home infusion therapy AOs. First,
the SAs are not available to perform validation surveys for home
infusion therapy AOs suppliers and other similar non-certified
providers and suppliers. Section 1864(a) of the Act provides the SA, by
agreement with the Secretary, provides services to the following
Medicare certified healthcare providers: Hospitals, skilled nursing
facilities, home health agencies, hospice programs, rural health
clinics, critical access hospitals, comprehensive outpatient
rehabilitation facilities, laboratories, clinics, rehabilitation
agencies, public health agencies, or ambulatory surgical centers.
Second, a validation program for home infusion therapy supplier AOs
would require the use of contractors. Third, achieving sample sizes
that are statistically significant from which to draw reliable
conclusions about AO performances across all home infusion therapy
suppliers would be problematic as there are a limited number of home
infusion therapy suppliers. Due to the factors stated previously, we
are not proposing to include validation requirements in the proposed
new regulations for the oversight of AOs that accredit suppliers at
this time. We seek public comment on the decision not to propose a
validation process at this time.
Even though we would not have a formal validation process in place,
we would be able to monitor the performance of the home infusion
therapy AOs as part of the ongoing AO oversight process provided for in
the proposed home infusion therapy AO approval and oversight
regulations at Sec. Sec. 488.1010 through 488.1050. For
[[Page 32453]]
example, under proposed Sec. 488.1030 we would have the ability to
perform performance reviews to evaluate the performance of each CMS-
approved home infusion therapy accreditation program on an ongoing
basis; comparability reviews to assess the equivalency of a home
infusion therapy AO's CMS-approved program requirements with the
comparable Medicare home infusion therapy accreditation requirements
after CMS imposes new or revised Medicare accreditation requirements;
and standards reviews when a home infusion therapy accrediting
organization proposes to adopt new or revised accreditation standards.
We may also perform CMS-approved home infusion therapy accreditation
program review if a comparability or performance, or standards review
reveals evidence of substantial non-compliance of a home infusion
therapy AO's CMS-approved home infusion therapy accreditation program
with the requirements of this subpart. (See proposed Sec. 488.1005
below for a definition of substantial non-compliance).
In addition, proposed Sec. 488.1035 would require the home
infusion therapy AOs to submit information to CMS which will help us
monitor the AO's performance. This information would also help to
ensure that the home infusion therapy suppliers accredited by the AO
provide care that meets the proposed health and safety standards
contained in 42 CFR part 486, subpart B. This information includes the
following:
Copies of all home infusion therapy supplier accreditation
surveys, together with any survey-related information.
Notice of all accreditation decisions.
Notice of all complaints related to the AO's accredited
suppliers.
Information about all home infusion therapy accredited
suppliers against which the home infusion therapy accreditation
organization has taken remedial or adverse action, including
revocation, withdrawal, or revision of the providers or suppliers
accreditation.
Annual basis, summary data specified by CMS that relate to
the past year's accreditation activities and trends.
Notice of any proposed changes in the home infusion
therapy accrediting organization's accreditation standards or
requirements or survey process.
d. Application Requirement for AOs That Currently Provide Accreditation
for Home Infusion Therapy Suppliers
In this rule, we are proposing to establish regulations for the
approval and oversight of AOs for home infusion therapy suppliers. We
are also proposing the health and safety standards which home infusion
therapy suppliers must meet, and which the home infusion AOs must meet
or exceed in their accreditation standards. These health and safety
standards are set forth at 42 CFR part 486, subpart I. The AOs that
currently accredit home infusion therapy suppliers have not heretofore
been governed by any CMS regulations related to home infusion therapy
accreditation or health and safety standards. These AOs have each
created their own set of accreditations standards. These accreditation
standards vary from AO to AO.
Section 1834(u)(5)(C) of the Act requires home infusion therapy
suppliers to be accredited in order to receive payment for the services
they provide. We propose to require that the home infusion therapy
accreditation program submitted to CMS for approval by each of the AOs
that currently accredit home infusion therapy suppliers be separate and
distinct accreditation programs that are not part of the AOs home
health accreditation program. We would further require that the AOs
home infusion therapy accreditation standards meet or exceed the
proposed health and safety standards for home infusion therapy
suppliers. Finally, we would require that the application meet the
requirements of proposed 42 CFR 488.1010.
We solicit comments on these proposals.
e. Oversight of Home Infusion Therapy Accrediting Organizations
As noted previously, we are proposing to create a new set of
regulations titled, ``Approval and Oversight of Home Infusion Therapy
Supplier Accrediting Organizations'' at 42 CFR part 488, subpart L.
These proposed regulations would set forth the application and
reapplication procedures for national AOs seeking approval or re-
approval of authority to accredit home infusion therapy suppliers;
ongoing CMS oversight processes for approved AOs that accredit home
infusion therapy suppliers; and, appeal procedures for AOs that
accredit home infusion therapy suppliers. In this section of the
proposed rule, we describe our proposed regulatory provisions.
The following sections discuss the proposed regulations, in their
proposed order.
(1) Basis and Scope (Sec. 488.1000)
We propose at Sec. 488.1000 to set forth the statutory authority
related to this set of proposed regulations. Sections 1834(u)(5) and
1861(iii) of the Act would be the statutory basis for these proposed
regulations. These sections of the Act provide the Secretary with the
authority necessary to carry out the administration of the Medicare
program. Section 1861 of the Act defines services, supplier types and
benefits, and over whom Medicare may have authority. Section 1861(d)
defines the term ``supplier.'' Section 1834(u)(5) of the Act governs
accreditation of home infusion therapy suppliers.
Section 1861(iii)(3)(D)(i)(III) of the Act requires that home
infusion therapy suppliers be accredited by an organization designated
under section 1834(u)(5)of the Act. Section 1834(u)(5) of the Act
requires that the Secretary establish factors in designating
accrediting organizations and designate accrediting organizations to
accredit suppliers furnishing home infusion therapy by January 1, 2021.
Proposed Sec. 488.1000(a) would set forth the statutory authority
for the accreditation of home infusion therapy suppliers by the home
infusion therapy AOs. Title 42 CFR 488.1000(b) would set forth the
scope of the proposed regulation, which is the application and
reapplication procedures for national AOs seeking approval or re-
approval of authority to accredit home infusion therapy suppliers;
ongoing CMS oversight processes for approved of home infusion therapy
AOs; and, appeal procedures for AOs of home infusion therapy suppliers.
(2) Definitions (Sec. 488.1005)
We are proposing to use the following definitions at Sec.
488.1005:
Accredited home infusion therapy supplier means a supplier
that has demonstrated substantial compliance with a CMS-approved
national home infusion therapy AO's applicable CMS-approved home
infusion therapy accreditation program standards, which meet or exceed
those of Medicare, and has been awarded accreditation by that AO.
Qualified home infusion therapy supplier means an entity
that meets the following criteria which are set forth at
1861(iii)(3)(D)(i): (1) Furnishes infusion therapy to individuals with
acute or chronic conditions requiring administration of home infusion
drugs; (2) ensures the safe and effective
[[Page 32454]]
provision and administration of home infusion therapy on a 7-day-a-
week, 24-hour-a-day basis; (3) is accredited by an organization
designated by the Secretary pursuant to section 1834(u)(5); and (4)
meets such other requirements as the Secretary determines appropriate.
Immediate jeopardy means a situation in which the
provider's or supplier's non-compliance with one or more Medicare
accreditation requirements has caused, or is likely to cause, serious
injury, harm, impairment, or death to a patient, as codified at Sec.
488.1.
National accrediting organization means an organization
that accredits supplier entities under a specific program and whose
accredited supplier entities under each program are widely dispersed
geographically across the United States. In addition, the specific
program is active, fully implemented, and operational. This definition
is codified at Sec. 488.1.
Reasonable assurance means an AO has demonstrated to CMS'
satisfaction that its accreditation program requirements meet or exceed
the Medicare program requirements. This definition is codified at Sec.
488.1.
Rural area means an area as defined at section
1886(d)(2)(D) of the Act.
Substantial allegation of non-compliance means a complaint
from any of a variety of sources (such as patient, relative, or third
party), including complaints submitted in person, by telephone, through
written correspondence, or in the newspaper, magazine articles or other
media, that would, if found to be present, adversely affect the health
and safety of patients and raises doubts as to a supplier's compliance
with any of the Medicare home infusion therapy accreditation
requirements. This definition is codified at Sec. 488.1.
(3) Application and Reapplication Procedures for National Accrediting
Organizations (Sec. 488.1010)
Proposed Sec. 488.1010 would contain application and re-
application procedures for all national AOs seeking CMS-approval of an
accreditation program for home infusion therapy suppliers. Proposed
Sec. 488.1010(a) would provide a comprehensive listing of the
information, supporting documentation, certifications, written
statements and other data that prospective AOs for home infusion
therapy suppliers would be required to include in their application for
approval to accredit home infusion therapy suppliers. The requirements
under this section would apply to both initial applications for CMS-
approval as well as applications for re-approval of an existing CMS-
approved home infusion therapy accreditation program. This section
would also require the AOs for home infusion therapy supplies to
furnish CMS with information that demonstrates that their accreditation
program requirements meet or exceed the applicable Medicare
requirements.
Proposed Sec. 488.1010(a)(1) would require AOs for home infusion
therapy suppliers seeking initial or renewed CMS-approval of their home
infusion therapy accreditation program to demonstrate that they meet
the definition of a ``national accrediting organization.'' Section 1865
of the Act requires that accrediting organizations be national in
scope.
We believe that because home infusion therapy suppliers are located
throughout the country, it is necessary for AOs to demonstrate their
ability to provide accreditation services in a variety of regions
across the country. In the May 22, 2015 final rule entitled, ``Medicare
and Medicaid Programs: Revisions to Deeming Authority, Survey,
Certification and Enforcement Procedures'' (80 FR 29802), we stated
that the term ``national in scope'' indicated a program already fully
implemented, operational, and widely dispersed geographically
throughout the country. However, we also stated that we would not
establish a minimum or a specific geographic distribution for provider
entities that the program must have already accredited. It is our
intent that this proposed section would require a home infusion therapy
AO to demonstrate that their accreditation program meets the ``national
in scope'' description as previously defined.
Proposed Sec. 488.1010(a)(2) would require AOs to specifically
identify the Medicare supplier type for which they are requesting CMS-
approval or reapproval. We believe it is necessary for an AO to
establish separate accreditation requirements for each supplier type
they accredit. There are many AOs that provide accreditation programs
for multiple types of provider and supplier types. When we receive an
application from such an AO, we would not know which type of
accreditation program the AO has submitted for CMS approval. For
example, the AO could be submitting a renewal application for one of
its existing accreditation programs. Therefore, it is helpful to CMS if
the AO identifies the type of accreditation for which they are seeking
approval at the beginning of the application.
Proposed Sec. 488.1010(a)(3) would require AOs to demonstrate
their ability to take into account the capacities of home infusion
therapy suppliers in rural areas (as defined in section
1834(u)(5)(A)(ii) of the Act. Rural home infusion therapy suppliers may
have limitations or access to care issues that do not apply to suburban
and urban home infusion therapy suppliers. These limitation may
include, but are not limited to the number of home infusion therapy
suppliers available in rural areas and limited home infusion therapy
services offered in rural areas. While we certainly would not permit
AOs that accredit any type of supplier to modify their accreditation
standards for suppliers in rural areas, these factors must be taken
into account as in accordance with section 1834(u)(5)(A)(ii) of the
Act.
Proposed Sec. 488.1010(a)(4) would require the home infusion
therapy AO to provide information that documents their knowledge,
expertise, and experience in the healthcare field for which they offer
accreditation and for which they are requesting approval. We believe
that to successfully develop accreditation program standards that can
provide CMS with reasonable assurance that accredited home infusion
therapy suppliers meet or exceed each of the applicable Medicare
requirements, evaluate compliance, support entities in their efforts to
identify and implement necessary corrective actions and monitor ongoing
compliance, an AO must possess subject matter expertise and experience
in that field.
Proposed Sec. 488.1010(a)(5) would require the AO to submit a
detailed crosswalk (in table format) that identifies, for each of the
applicable Medicare health and safety requirements, the exact language
of the accrediting organization's comparable accreditation requirements
and standards. This requirement would allow CMS to evaluate whether the
accreditation program standards meet or exceed the applicable Medicare
requirements. We note that an AO for home infusion therapy suppliers
could set standards that exceed the Medicare requirements in the
accreditation program it submits to CMS for approval. However, at a
minimum, AOs for home infusion therapy suppliers would have to provide
evidence that their accreditation program utilizes standards and
procedures that met or exceeded applicable Medicare requirements.
Proposed Sec. 488.1010(a)(6) would require each AO for home
infusion therapy suppliers to provide a detailed description of its
survey process. This requirement is intended to allow CMS to gain a
better understanding of an AO's proposed survey process and ensure that
its survey and enforcement
[[Page 32455]]
processes are comparable to Medicare's health and safety standards
(contained in 42 CFR part 486, subpart I). The specific type of
information to be provided under this section is set forth in proposed
Sec. 488.1010(a)(6)(i) through (vii) and includes, but is not limited
to, the following: (1) A detailed description of the survey process;
(2) type and frequency of surveys performed; (3) copies of the AO's
survey forms; (4) documentation that the survey reports identify the
comparable Medicare home infusion therapy health and safety
requirements for each finding of non-compliance with accreditation
standards; (5) timeline and procedures for monitoring home infusion
therapy suppliers found to be out of compliance; (6) process for
addressing deficiencies; and (7) the ability of the AO to conduct
timely review of accreditation applications.
We propose at Sec. 488.1010(a)(6)(viii) to require the AOs for
home infusion therapy suppliers to acknowledge, that as a condition for
CMS approval, the AO agrees to provide CMS with information extracted
from each accreditation onsite survey, offsite audit or other
evaluation strategy as part of its data submission required under Sec.
488.1010(a)(21)(ii). Upon request, the AO must also provide CMS with a
copy of the most recent accreditation onsite survey, offsite audit, or
other evaluation strategy together and any other information related to
the survey process as CMS may require, including, but not limited to
corrective action plans.
Proposed Sec. 488.1010(a)(6)(ix) would require the AOs for home
infusion therapy suppliers to provide a statement acknowledging that
they will notify CMS within two business days, using a CMS specified
format, when an accreditation survey or complaint investigation
identifies the presence of an immediate jeopardy situation. For
purposes of this section, the term ``immediate jeopardy'' is defined in
proposed Sec. 488.1005.
We propose at Sec. 488.1010(a)(7) to require the AOs for home
infusion therapy suppliers to establish procedures related to
performance of onsite surveys, offsite audits, and other survey
activities. Proposed Sec. 488.1010(a)(7)(i) would require the home
infusion therapy AOs that performs onsite surveys to make sure that
they are unannounced and that they establish procedures to prevent
against unannounced surveys from becoming known to the supplier in
advance of the visit. The purpose of unannounced onsite surveys is to
prevent the supplier from performing significant preparations for the
survey to the extent that their environment would be so modified that
it does not represent the normal daily operating conditions of the home
infusion therapy supplier's office. If a provider is given advanced
notice of a survey, they may attempt to make extensive preparations for
the survey to the extent that they may attempt to hide patient safety
issues such as a broken or malfunctioning medication infusion pump,
areas of risk such as infection control, and ensuring that the patient
receives the correct type and dosage of medication, poor quality of
care such as failure to properly cleanse the insertion site before
inserting IV access, and failure to perform periodic IV site care, or
non-compliance that would normally be present.
Proposed Sec. 488.1010(a)(7)(ii) would require home infusion
therapy AOs that use offsite audits, or other evaluation strategies to
evaluate the quality of services provided by a home infusion therapy
supplier, to follow up these offsite audits with periodic onsite
visits. We believe that it is very important for the AOs that accredit
home infusion therapy suppliers to follow-up off-site survey reviews
with periodic on-site visits to ensure that the home infusion therapy
supplier is complying with all accreditation standards and meeting all
health and safety regulations. The requirements of this section are
consistent with existing CMS policy related to the performance of
unannounced surveys specified in Chapter 2 of the CMS State Operations
Manual (SOM). Chapter 2 of the State Operations Manual (SOM) applies to
Medicare-certified providers and suppliers. Our intent for referencing
Chapter 2 of the SOM is to show that the proposed provisions related to
onsite surveys for home infusion therapy suppliers are consistent with
the requirements for Medicare-certified providers and suppliers. Also,
it is our intent is to have consistent regulations for the approval and
oversight of AOs, to the extent possible, across all AOs.
We propose at Sec. 488.1010(a)(8), to require an AO for home
infusion therapy suppliers to provide a description of the criteria for
determining the size and composition of the onsite survey or offsite
audit teams or teams used for other accreditation evaluation
strategies. These teams would perform onsite surveys at individual home
infusion therapy supplier locations, offsite audits, and any other
types of accreditation review activity that is performed by the AO. The
AO's criteria should include, but not be limited to, the following
information:
The expected number of individual home infusion therapy
supplier locations to be surveyed using an onsite survey.
The expected number of home infusion therapy suppliers to
be surveyed using off-site audits.
A description of other types of accreditation review
activities to be used.
The reasons for each type of survey (that is, initial
accreditation survey, reaccreditation survey; and complaint surveys).
Adherence to the requirements of this section would help CMS ensure
that each home infusion therapy AO has established criteria for
determining the appropriate size and composition of its survey teams.
It is important that an AO assemble survey teams that are large enough
and have the required knowledge, experience and training to properly
and adequately survey home infusion therapy suppliers. We believe that
surveys performed by competent, well trained surveyor teams would
provide CMS with reasonable assurance that accredited home infusion
therapy suppliers meet or exceed the applicable quality standards.
We propose at Sec. 488.1010(a)(9) to require that an AO for home
infusion therapy suppliers provide CMS with information regarding the
overall adequacy of the number of surveyors, auditors, and other staff
available to perform all survey related activities. Under this section,
the home infusion therapy AO would also be required to provide an
explanation as to how it would maintain an adequate number of trained
surveyors on staff. The home infusion therapy AO must also describe its
ability to increase the size of survey, audit, and other survey program
staff to match growth in the number of accredited home infusion therapy
suppliers while maintaining re-accreditation intervals for existing
accredited home infusion therapy suppliers. The intent of these
proposed requirements is to ensure that AOs for home infusion therapy
suppliers maintain sufficient staffing levels over time which would
enable them to meet the needs of their clients and also perform timely
and accurate surveys. We recognize that within a given accreditation
program, there can be variations in the size and complexity of
individual home infusion therapy suppliers. Therefore, we believe that
adding a regulatory requirement to specify a uniform size and
composition of an AO survey teams would not be appropriate.
We propose at Sec. 488.1010(a)(10) to require that an AO for home
infusion
[[Page 32456]]
therapy suppliers provide CMS with detailed information about the
individuals who perform survey activities, including onsite surveys,
offsite audits and other review processes, for the purpose of ensuring
accredited home infusion therapy suppliers maintain adherence to the
accreditation program requirements. More specifically, proposed Sec.
488.1010(a)(10)(i) would require the AOs to furnish information about
the numbers of professional and technical staff available for
accreditation related activities, as well as the educational background
and experience requirements for its surveyors, auditors and reviewers.
Proposed Sec. 488.1010(a)(10)(ii) would require the AO to provide
information about the educational, past experience and employment
requirements surveyors must meet. Proposed Sec. 488.1010(a)(10)(iii)
would require the AO to provide information about the content and
length of the orientation program for newly hired surveyors, auditors
and reviewers.
These requirements would help ensure that AOs for home infusion
therapy suppliers hires survey team staff members that possess the
requisite knowledge, expertise, training, and experience specific to
home infusion therapy suppliers. We believe it is imperative that
surveys be performed by properly educated and trained staff in order to
be valid and accurate. This proposed section is also intended to help
ensure that the home infusion therapy AO maintains an adequate number
of properly trained surveyors so that it would be able to meet the
demand for all surveys, both initial and re-accreditation, to be
performed for all clients.
We propose at Sec. 488.1010(a)(11) to require each AO for home
infusion therapy suppliers to describe the content, frequency and types
of in-service training provided to survey and audit personnel. This
requirement would help ensure that AO personnel who perform surveys,
audits and other review-related activities maintain the skills and
knowledge necessary to perform their work with competency. We believe
that surveys performed by competent, well trained surveyor teams would
provide CMS with reasonable assurance that accredited home infusion
therapy suppliers meet or exceed the applicable quality standards.
We propose at Sec. 488.1010(a)(12) to require AOs for home
infusion therapy suppliers to provide documentation which describes the
evaluation systems used to monitor the performance of individual
surveyors, survey teams, and staff that perform audit activities. This
proposed requirement would provide CMS with insight into how each home
infusion therapy AO measures the performance of their surveyors, survey
teams and staff that perform audit activities. This requirement would
provide CMS with the ability to assess whether an AO has a credible
process for ongoing evaluations of its surveyors, survey teams, and
staff that perform audit activities.
We believe that the performance evaluation of a home infusion
therapy AO's surveyors, survey team and other staff that perform survey
and audit activities can have a significant impact on the effectiveness
of the home infusion therapy AO's survey processes.
We propose at Sec. 488.1010(a)(13) to require the AO for home
infusion therapy suppliers to provide the organization's policies and
procedures for avoiding and handling conflicts of interest, including
the appearance of conflicts of interest, involving individuals who
conduct surveys, audits or participate in accreditation decisions. This
proposed provision would help CMS to determine if home infusion therapy
AO has policies to avoid potential conflicts of interest that could
undermine the integrity of its accreditation program.
We propose at Sec. 488.1010(a)(14) to require the AO for home
infusion therapy suppliers to provide CMS with documentation of its
policies and procedures for handling disputes filed by a home infusion
therapy supplier regarding survey or audit findings, or an adverse
decision. The intent of this proposed section is to ensure that a home
infusion therapy AO has procedures in place to ensure that those
suppliers who wish to dispute the AO's survey findings or appeal an
adverse decision are provided with notice of their organizational and
statutory appeal rights.
We propose at Sec. 488.1010(a)(15) to require that home infusion
therapy AOs provide CMS with copies of the policies and procedures to
be used when an accredited home infusion therapy supplier either--(1)
removes or ceases furnishing services for which they are accredited; or
(2) adds home infusion therapy services for which they are not
accredited. This proposed requirement would ensure there is timely
communication between the accredited home infusion therapy supplier and
the AO, when changes in the supplier's circumstances occur that would
have an impact on the status of their accreditation.
We propose at Sec. 488.1010(a)(16) to require the home infusion
therapy AOs to provide CMS with the organization's policies and
procedures for responding to and investigating complaints and
grievances against accredited suppliers. These policies and procedures
should include a specific procedure for coordinating with and making
referrals, when applicable, to the appropriate licensing bodies,
ombudsman's offices and CMS. It is our intent that each CMS-approved
home infusion therapy AO has policies and procedures in place for
handling complaints and grievances. We believe it is important that any
complaints against an accredited home infusion therapy supplier be
investigated promptly and fairly. It is also important that the
appropriate referrals be made when necessary.
We propose at Sec. 488.1010(a)(17) to require that the home
infusion therapy AOs furnish a description of the AO's accreditation
status decision-making process. Proposed Sec. 488.1010(a)(17)(i) would
require the organization to furnish its process for addressing a home
infusion therapy supplier deficiencies with meeting accreditation
program requirements. This section would also require the home infusion
therapy AO to provide a description of the procedures used to monitor
the correction of deficiencies identified during the accreditation
survey and audit process. It is important for CMS to ensure that the
home infusion therapy AOs are properly addressing the home infusion
therapy supplier's deficiencies and requiring appropriate corrective
action.
We propose at Sec. 488.1010(a)(17)(ii) to require that the home
infusion therapy AOs furnish a description of all types and categories
of accreditation decisions associated with the program, including the
duration of each of the organization's accreditation decisions.
Proposed Sec. 488.1010(a)(17)(iii) would require the home infusion
therapy AO to provide information about its procedures for the
granting, withholding or removal of accreditation status for home
infusion therapy suppliers that fail to meet the AO's standards or
requirements. This proposed section would also require the home
infusion therapy AO to identify the procedures related to assignment of
less than full accreditation status or other actions taken by the home
infusion therapy AO in response to non-compliance with its standards
and requirements. Since the granting of full or less than full
accreditation status is an essential component of a home infusion
therapy AO's accreditation decision process, we believe that it is
necessary for CMS to receive information on the policies and
[[Page 32457]]
procedures pertaining to these types of decisions as well.
We propose at Sec. 488.1010(a)(17)(iv) to require the home
infusion therapy AO to furnish a statement acknowledging that the
organization agrees to notify CMS (in a manner specified by CMS in
subregulatory guidance) of any decision to revoke or terminate,
withdraw, or revise the accreditation status of a home infusion therapy
supplier within 3 business days from the date the organization takes an
action. ``Revocation'' or ``termination'' represents an involuntary
cessation of a home infusion therapy supplier's accreditation. A
revocation or termination of accreditation could include an action
taken when a home infusion therapy AO concludes that a home infusion
therapy supplier is substantially non-compliant with accreditation
standards and has not corrected its deficient practices within the
timeframe specified by the home infusion therapy AO. A home infusion
therapy AO could also revoke or terminate a home infusion therapy
supplier's accreditation due to the non-payment of accreditation fees.
We define the term ``revised'' accreditation status as a change in the
accreditation status of a home infusion therapy supplier based on the
formal accreditation status categories used by a home infusion therapy
AO. These changes could include adverse changes that fall short of
revocation, as well as positive changes reflecting improved compliance.
This is in contrast to a ``withdrawal'' which is a voluntary decision
on the part of the home infusion therapy supplier to end its
participation in the AO's accreditation program.
Our intent with this proposed requirement is to require that home
infusion therapy AOs notify CMS when they have taken a final action
concerning a change in the accreditation status of a home infusion
therapy supplier. If a home infusion therapy supplier has filed a
request for an administrative appeal of the AO's decision to revoke or
terminate accreditation, the action on the part of the home infusion
therapy AO to revoke or terminate accreditation cannot be finalized
until after the conclusion of the administrative appeals process. In
this case, the home infusion therapy AO would be required to send
notice of their final action to CMS no later than three business days
after that appeals process has concluded and a final AO determination
has been made.
We propose at Sec. 488.1010(a)(18) to require a home infusion
therapy AOs to provide CMS with a list of all home infusion therapy
suppliers currently accredited by that home infusion therapy AO. This
list must include the type and category of accreditation held by each
home infusion therapy supplier and the expiration date of each
supplier's current accreditation.
We propose at Sec. 488.1010(a)(19) to require that the home
infusion therapy AOs provide CMS with a schedule of all survey activity
(including but not limited to onsite surveys, offsite audits and other
types if survey strategies), expected to be conducted by the home
infusion therapy AO during the 6-month period following submission of
the application. This proposed requirement would apply to both initial
and renewal applications. Under this proposed section, the home
infusion therapy AO would be required to provide us with its survey
activity schedule for the 6-month period following submission of their
application for approval to survey and accredit home infusion therapy
suppliers. We would use the survey schedule to plan our survey
observation as part of our review of the home infusion therapy AO's
application.
We propose at Sec. 488.1010(a)(20) to require that the home
infusion therapy AO submit a written statement or document that
demonstrates the organization's ability to furnish CMS with the
electronic data the home infusion therapy AO must report to CMS as
required by proposed Sec. 488.1035. The information and data to be
provided under this section would assist us in providing effective
oversight of the approved home infusion therapy accreditation programs.
This information is necessary for effective assessment and validation
of the home infusion therapy AO's survey process.
These proposed regulations will require the AO to submit
documentation to CMS on a periodic basis. The intent of this
requirement is to ensure that the AO is able to provide CMS with the
required data electronically. CMS is cutting down of the use of printed
documents and maximizing the use of electronic document storage.
We propose at Sec. 488.1010(a)(21) to require that the home
infusion therapy AO provide a description of the organization's data
management and analysis system with respect to its surveys and
accreditation decisions. Proposed Sec. 488.1010(a)(21)(i) would
require the home infusion therapy AO to furnish a detailed description
of how the home infusion therapy AO uses its data to assure compliance
of its home infusion therapy accreditation program with the
corresponding Medicare requirements.
We propose at Sec. 488.1010(a)(21)(ii) to require the home
infusion therapy AO to submit a written statement in which the home
infusion therapy AO acknowledges that it agrees to submit timely,
accurate, and complete data, which CMS determines necessary for
evaluation of the home infusion therapy AO's performance, and which
would not be unduly burdensome to submit. The data to be submitted,
according to proposed Sec. 488.1010(a)(21)(ii)(B) would include,
accredited home infusion therapy supplier identifying information,
survey findings, quality measures, and notices of accreditation
decisions. The home infusion therapy AO would further agree to submit
the necessary data according to the instructions and timeframes CMS
specifies through subregulatory guidance.
This data would allow CMS to obtain information about how the home
infusion therapy AO would use its data management systems to meet or
exceed Medicare home infusion therapy accreditation requirements as set
forth in this subpart. The proposed data would also assist us in
providing effective oversight of the approved home infusion therapy
accreditation program.
We propose at Sec. 488.1010(a)(22) to require the home infusion
therapy AO to furnish the three most recent annual audited financial
statements from their organization. The purpose of this proposed
requirement would be to verify that the home infusion therapy AO's
staffing, funding, and other resources are adequate to perform the
required surveys, audits and related activities in order to maintain
the home infusion therapy accreditation program on a national basis.
This requirement is also intended to insure that a home infusion
therapy AO has the financial stability to ensure ongoing, stable
operations and longevity.
Proposed Sec. 488.1010(a)(23) would require the home infusion
therapy AOs to provide a written statement, in which the home infusion
therapy AO acknowledges, as a condition for approval, that the
organization agrees to the items set forth in Sec. 488.1010(a)(23)(i)
through (vi).
Proposed Sec. 488.1010(a)(23)(i) would require the home infusion
therapy AO to provide a written statement acknowledging that, as a
condition for approval, that if the home infusion therapy AO decides to
voluntarily terminate its accreditation program, the home infusion
therapy AO must provide written notification to CMS and all home
infusion therapy suppliers accredited by that AO. This written
[[Page 32458]]
notice must be provided at least 90 calendar days in advance of the
effective date of the home infusion therapy AOs decision to voluntarily
terminate its CMS-approved accreditation program. This notice must
contain the all of following information:
Notice that the home infusion therapy AO is voluntarily
terminating its home infusion therapy accreditation program.
The effective date of the termination.
The implications for the home infusion therapy supplier's
payment status once their current term of accreditation expires in
accordance with the requirements set forth at Sec. 488.1045(a).
Proposed Sec. 488.1010(a)(23)(ii) would require the home infusion
therapy AO to provide a written statement acknowledging that, as a
condition for approval, that, a home infusion therapy AO must provide
written notification of an involuntary withdrawal of CMS approval of
its home infusion therapy accreditation program to all its accredited
home infusion therapy suppliers. This written notice must be provided
by the home infusion therapy AO to all of its accredited home infusion
therapy suppliers no later than 30 calendar days after the public
notice is published in the Federal Register announcing that CMS is
withdrawing its approval of the accreditation program in accordance
with the requirements at Sec. 488.1045(b). This Federal Register
notice must state the implications for the providers' or suppliers'
payment status once their current term of accreditation expires. Home
infusion therapy suppliers would no longer be eligible to receive
Medicare payments upon expiration of the current term of accreditation.
Therefore, it is critical that the home infusion therapy supplier seek
accreditation immediately through another CMS-approved home infusion
therapy accreditor.
Proposed Sec. 488.1010(a)(23)(ii)(A) would require the home
infusion therapy AO to acknowledge that they must send a second written
notification, as a reminder to all accredited home infusion therapy
suppliers within ten calendar days of the organization's removal from
the list of CMS-designated home infusion therapy AOs. We believe that
this second reminder to the accredited home infusion therapy suppliers
who are in danger of having a lapse of accreditation is very important.
This notice would remind the home infusion therapy suppliers that they
must seek another home infusion therapy accreditor to avoid a lapse in
accreditation, and subsequently a lapse in Medicare payment.
Proposed Sec. 488.1010(a)(23)(ii)(B) would require the home
infusion therapy AO to acknowledge that they will notify CMS, in
writing, (either electronically or in hard copy format) within 2
business days of identification of an immediate jeopardy situation that
has been identified in any accredited home infusion therapy supplier.
An immediate jeopardy situation is presented when a provider or
supplier exhibits a deficiency hat poses serious risk of harm or death
to the home infusion therapy supplier's patients, staff or visitors, or
poses a hazard to the general public. Immediate jeopardy situations are
of such a serious nature that it is important that they be identified
and removed as quickly as possible. We propose the 2-day notification
requirement because CMS must notified of immediate jeopardy situations
as quickly as possible so that we can monitor these serious situations
and take action as appropriate.
We propose at Sec. 488.1010(a)(23)(iii) to require the home
infusion therapy AO to provide CMS with an annual summary of
accreditation activity data and trends, including, but not limited to,
deficiencies, complaints, terminations, withdrawals, denials,
accreditation decisions, and other survey related activities as
specified by CMS. We believe that it is important for CMS to monitor
this information as part of our oversight of the home infusion therapy
AOs performance.
Proposed Sec. 488.1010(a)(23)(iv), would require a home infusion
therapy AO to work collaboratively with CMS in the event that CMS
terminates the home infusion therapy AO's approved status, to direct
its accredited home infusion therapy suppliers to the remaining CMS-
approved home infusion therapy AOs within a reasonable period of time.
We would require the terminated home infusion therapy AO to perform
this task because its accredited home infusion therapy suppliers would
be left with no accreditation as a result of the termination of the
home infusion therapy AOs CMS-approval. Therefore, we believe that the
terminated home infusion therapy AO has some responsibility to help
their accredited home infusion therapy suppliers seek alternative
accreditors as soon as possible.
Proposed Sec. 488.1010(a)(23)(v), would require the home infusion
therapy AOs to notify CMS of any significant proposed changes in its
CMS-approved accreditation program requirements or survey process.
Under this section, the home infusion therapy AO would be required to
submit their notice of revised program requirements or changes in the
survey process to CMS in writing no less than 60 days in advance of the
proposed implementation date. As required by proposed Sec.
488.1030(c)(1), the home infusion therapy AO would be required to agree
not to implement the proposed changes without prior written notice of
continued program approval from CMS, except as provided for at Sec.
488.1030(c)(4).
Proposed Sec. 488.1010(a)(23)(vi), would require the home infusion
therapy AOs to provide a statement acknowledging that if they receive a
written notice from CMS which states that there has been a change in
the applicable Medicare home infusion therapy substantive health and
safety requirements, the home infusion therapy AO must provide CMS with
proposed corresponding changes in the home infusion therapy
accreditation requirements for its CMS-approved home infusion therapy
accreditation program. This requirement is intended to ensure that the
AO's accreditation standards continue to meet or exceed those of
Medicare, and that the AO's survey process remains comparable with that
of Medicare.
Section 488.1010(a)(23)(vi) provides that in the event that CMS
makes a change in the applicable home infusion therapy accreditation
requirements, the home infusion therapy AO must comply with several
requirements. First, proposed Sec. 488.1010(a)(23)(vi)(A) would
require the home infusion therapy AO to submit its responsive proposed
changes in their accreditation requirements and survey processes to CMS
within 30 calendar days of the date of the written CMS notice to the
home infusion therapy AO or by a date specified in the notice,
whichever is later. However, CMS will give due consideration to a home
infusion therapy AO's request for an extension of the deadline as long
as it is submitted prior to the due date. Second, proposed Sec.
488.1010(a)(23)(vi)(B) would require that the home infusion therapy AO
not implement its proposed responsive changes without prior written
notice of continued program approval from CMS, except as provided for
at Sec. 488.1030(b)(1)(v).
Proposed Sec. 488.1010(a)(24) would require the home infusion
therapy AOs to provide CMS with a listing of the organization's
proposed fees for home infusion therapy accreditation. The home
infusion therapy AO must notify CMS of any plans for reducing the
burden and cost of accreditation to small or rural home infusion
therapy suppliers. While CMS does not
[[Page 32459]]
undertake to set or regulate the fees charges by a home infusion
therapy AO, we do review fees charged by AOs to determine whether they
are reasonable as directed by sections 1834(u)(5)(A)(iii) of the Act.
Proposed Sec. 488.1010(b) would require home infusion therapy AOs
to agree to submit any additional information, documentation, or
attestations, including items not previously listed that CMS may deem
necessary to make a determination for approval or denial of the home
infusion therapy AO's application. Should we require this additional
information, we would notify the home infusion therapy AO of the
request and provide the home infusion therapy AO with a reasonable
timeframe to submit the requested information.
We propose at Sec. 488.1010(c) to allow a home infusion therapy AO
to withdraw its initial application for CMS's approval of its home
infusion therapy accreditation program at any time before we publish
the final Federal Register notice described at Sec. 488.1020(b). The
intent of this provision is to provide home infusion therapy AOs that
have encountered difficulty meeting the requirements described at Sec.
488.1010(a) during the application process with the option to
voluntarily withdraw their application before CMS publishes the final
decision in the Federal Register as required by proposed Sec.
488.1020(b). Proposed Sec. 488.1020(b) would require that the final
notice, published by CMS, specify the basis for our decision. Because
the Federal Register is a public forum, we believe it is likely that
home infusion therapy AOs would choose to voluntarily withdraw their
application instead of having information about the non-compliance of
their home infusion therapy accreditation program made publicly
available. This may be especially true for those home infusion therapy
AOs that wish to reapply for approval of their accreditation program in
the future. A voluntary withdrawal of an application by the home
infusion therapy AO would terminate the application review process
prior to publication of the final decision in the Federal Register.
Proposed Sec. 488.1010(d) would require CMS to complete its review
of an application submitted by a home infusion therapy AO within 210
calendar days from the date that CMS determines that the application is
complete. We propose that to determine completeness, each application
would be assigned to a technical review team upon receipt by CMS. This
team would perform a completeness review to determine if the
application contains all documents and supplemental information
required by proposed Sec. 488.1010(a). Lastly, we propose that if the
application is not complete, the review team would contact the home
infusion therapy AO and request that they submit any missing
information or documents in accordance with Sec. 488.1010(b).
We seek public comment on the proposal related to the proposed
application requirements set forth in proposed Sec. 488.1010. We
further seek comments on the burden related to the requirements of the
application procedure.
(4) Resubmitting a Request (Sec. 488.1015)
Proposed Sec. 488.1015(a) would require that except as provided in
paragraph (b), a home infusion therapy AO whose request for CMS's
approval or re-approval of a home infusion therapy accreditation
program was denied, or an organization that has voluntarily withdrawn
an initial application, could resubmit its application if the
organization had: (1) Revised its accreditation program to address the
issues related to the denial of its previous request or its voluntary
withdrawal; and (2) resubmitted the application in its entirety.
Proposed Sec. 488.1015(b) would provide that a home infusion
therapy AO that had asked for reconsideration of an application denial
by CMS could not submit a new application until the pending
reconsideration was administratively final. This provision would ensure
that review of accreditation matters on reconsideration are pending
before only one administrative agency and one administrative level at a
time.
We seek public comments on the requirements of proposed Sec.
488.1015.
(5) Public Notice and Comment (Sec. 488.1020)
Proposed Sec. 488.1020(a) would require CMS to publish a notice in
the Federal Register upon receipt of a complete application package.
The notice would identify the organization, the type of home infusion
therapy suppliers covered by the accreditation program, and provides
for at least a 30-day public comment period (which begins on the date
of publication of the Federal Register notice). The purpose of the
Federal Register notice is to notify the public that a national AO has
filed an application for approval of a home infusion therapy
accreditation program and to seek public comment in response to this
application. The requirement for the publication of a notice in the
Federal Register when an application is received is an existing
regulatory procedural requirement for all other AO types. We have added
this requirement to the home infusion therapy AO approval and oversight
regulations for consistency.
Proposed Sec. 488.1020(b) would require that when CMS approves or
re-approves an application for approval of a home infusion therapy AO's
accreditation program, a final notice would be published in the Federal
Register. This notice would have to specify the basis for CMS'
decision. Proposed Sec. 488.1020(b)(1), would require that our final
notice include at a minimum, the following information: (1) How the
accreditation program met or exceeded Medicare accreditation program
requirements; (2) the effective date of the CMS approval, which is not
later than the publication date of the notice; and (3) the term of the
approval (6 years or less).
If CMS makes a decision to disapprove a home infusion therapy AOs
application, our final notice would state the deficiencies found in the
application and the reason why the AOs accreditation program did not
met or exceeded Medicare accreditation program requirements. However,
an AO has the option of voluntarily withdrawing its application at any
time up until the publication of the final notice.
We propose at Sec. 488.1020(b)(2) that if CMS did not approve a
home infusion therapy AO's application for approval of its home
infusion therapy accreditation program, the final notice would explain
how the home infusion therapy AO failed to meet Medicare home infusion
therapy accreditation program requirements. This notice would indicate
the effective date of the decision.
We seek comment on the requirements of proposed Sec. 488.1020,
including on the appropriate term for approval of an AO.
(6) Release and Use of Accreditation Surveys (Sec. 488.1025)
Proposed Sec. 488.1025 would require a home infusion therapy AO to
include, in its accreditation agreement with each home infusion therapy
supplier, an acknowledgement that the home infusion therapy supplier
agrees to release to CMS a copy of its most current accreditation
survey and any information related to the survey that CMS may require,
including the home infusion therapy supplier's corrective action plans.
Proposed Sec. 488.1025(a) would provide that CMS may determine that a
home infusion therapy supplier does not meet the applicable Medicare
[[Page 32460]]
conditions or requirements on the basis of its own investigation of the
accreditation survey or any other information related to the survey.
Proposed Sec. 488.1025(b) would prohibit CMS from disclosing home
infusion therapy survey reports or survey related information according
to section 1865(b) of the Act. However, CMS would be permitted to
publically disclose an accreditation survey and information related to
the survey, upon written request, to the extent that the accreditation
survey and survey information is related to an enforcement action taken
by CMS.
CMS would use the home infusion therapy supplier accreditation
survey information for purposes such as: (1) Confirmation of the home
infusion therapy supplier's eligibility for Medicare participation; (2)
to review and approve the home infusion therapy AO's recommendations
regarding accreditation; (3) to review the home infusion therapy AO's
investigations of complaints; and (4) to review the corrective action
taken by the AO when deficiencies are found on survey.
We seek public comments on the requirements of proposed Sec.
488.1025.
(7) Ongoing Review of Accrediting Organizations (Sec. 488.1030)
Proposed Sec. 488.1030 would clarify that a formal accreditation
program review could be opened on an ongoing basis. Specifically, this
section would describe standardized requirements related to the ongoing
federal review of home infusion therapy AOs and their approved
accreditation programs. This proposed section would clarify that CMS
oversight of accreditation programs is consistent across home infusion
therapy AOs. We are committed to treating all home infusion therapy AOs
subject to our oversight in the same manner. Under proposed Sec.
488.1030, we could conduct the following three types of reviews of an
AOs home infusion therapy accreditation programs: (1) Performance
review; (2) comparability review; and (3) CMS-approved accreditation
program review.
Proposed Sec. 488.1030(a) would allow CMS to perform a performance
review, in which we would evaluate the performance of each CMS-approved
home infusion therapy accreditation program on an ongoing basis.
Specifically, we would review the following aspects of a home infusion
therapy AO's for home infusion therapy program performance: The
organization's survey activity, and the organization's continued
fulfillment of the requirements stated in Sec. 488.1010.
Proposed Sec. 488.1030(b) would allow CMS to perform a
comparability review to assess the equivalency of a home infusion
therapy AO's CMS-approved home infusion therapy accreditation program
requirements with comparable Medicare home infusion therapy
accreditation requirements. Proposed Sec. 488.1030(b)(1) would allow
CMS to perform a comparability review when CMS imposes new or revised
Medicare accreditation requirements. When this occurs, proposed Sec.
488.1030(b)(1) would require CMS to provide written notice to the home
infusion therapy AOs when changes have been made to the Medicare home
infusion therapy accreditation requirements. Proposed Sec.
488.1030(b)(2) would require the home infusion therapy accrediting
organization to make revision to its home infusion therapy
accreditation standards or survey process so as to incorporate the new
or revised Medicare accreditation requirements.
Proposed Sec. 488.1030(b)(3) would further require that the
written notice sent by CMS to the home infusion therapy AO specify a
deadline (not less than 30 days) by which the home infusion therapy AO
must prepare and submit their proposed home infusion therapy
accreditation program requirement revisions and the timeframe for
implementation. Proposed Sec. 488.1030(b)(4) would allow a home
infusion therapy AO to submit a written request for an extension of the
submission deadline as long as this request was submitted prior to the
original deadline.
Proposed at Sec. 488.1030(b)(5) would require that, after
completing the comparability review, CMS would provide written
notification to the home infusion therapy AO, specifying whether or not
their revised home infusion therapy accreditation program standards
continued to meet or exceed all applicable Medicare requirements. We
propose at Sec. 488.1030(b)(6) that if, no later than 60 days after
receipt of the home infusion therapy AO's proposed accreditation
standard changes, CMS did not provide the written notice to the home
infusion therapy AO, then the revised home infusion therapy program
accreditation standards would be deemed to meet or exceed all
applicable Medicare requirement and the accreditation program would
have continued CMS-approval without further review or consideration.
Proposed Sec. 488.1030(b)(7) would provide that if a home infusion
therapy AO was required to submit a new application because CMS imposed
new regulations or made significant substantive revisions to the
existing regulations, CMS would provide notice of the decision to
approve or disapprove the application within the time period specified
in Sec. 488.1010(d).
We propose at Sec. 488.1030(b)(8) that if a home infusion therapy
AO failed to submit its proposed changes within the required timeframe,
or failed to implement the proposed changes that had been determined by
CMS to be comparable, CMS could open an accreditation program review in
accordance with Sec. 488.1030(d).
When a home infusion therapy AO proposes to adopt new home infusion
therapy accreditation standards or changes, in its survey process, we
propose at Sec. 488.1030(c)(1) to require the home infusion therapy AO
to provide notice to CMS no less than 60 days prior to the planned
implementation date of the proposed changes. Proposed Sec.
488.1030(c)(2) would prohibit the home infusion therapy AO from
implementing these changes before receiving CMS' approval except as
provided in Sec. 488.1030(c)(4). Proposed Sec. 488.1030(c)(3) would
require that this written notice contain a detailed description of the
changes to be made to the organization's home infusion therapy
accreditation standards, including a detailed crosswalk (in table
format) that states the exact language of the revised accreditation
requirements and the corresponding Medicare requirements for each. The
requirements of Sec. Sec. 488.1030(c)(2) and 488.10(c)(3) would ensure
that the home infusion therapy AO provides CMS with advance notice of
any proposed changes to their home infusion therapy accreditation
requirements and survey processes. This notice would allow CMS time to
review these proposed changes to ensure that the revised home infusion
therapy accreditation standards and survey processes continue to meet
or exceed all applicable Medicare home infusion therapy requirements
and continue to be comparable to all applicable Medicare home infusion
therapy survey processes, and provide a response to the home infusion
therapy AO. This section would also prohibit home infusion therapy AOs
from implementing any of the proposed changes in their home infusion
therapy accreditation requirements and survey processes, until CMS
approval has been received. We seek comment on this proposal.
Proposed Sec. 488.1030(c)(4) would require CMS to provide written
notice to the home infusion therapy accrediting organization indicating
whether the home infusion therapy accreditation program, including the
proposed revisions, continued or does not
[[Page 32461]]
continue to meet or exceed all applicable Medicare home infusion
therapy requirements. If CMS found that the accrediting organization's
home infusion therapy accreditation program, including the proposed
revisions did not continue to meet or exceed all applicable Medicare
home infusion therapy requirements. CMS would have to state the reasons
for these findings.
Proposed Sec. 488.1030(c)(5) would require CMS to provide this
written notice to the home infusion therapy AO by the 60th calendar day
following receipt of the home infusion therapy AO's written proposed
changes as to whether the home infusion therapy AO's revised home
infusion therapy accreditation program standards and survey processes
have been be deemed to meet or exceed all applicable Medicare home
infusion therapy requirements and have continued CMS approval without
further review or consideration. This proposed section would further
specify that if CMS failed to provide the required written notice to
the home infusion therapy AO by the 60 day deadline, the home infusion
therapy AO's revised accreditation program standards would be deemed to
meet or exceed all applicable Medicare requirements and have continued
CMS approval without further review or consideration.
Proposed Sec. 488.1030(c)(5) would permit CMS to open an
accreditation program review, in accordance with proposed Sec.
488.1030(d), if a home infusion therapy AO implemented changes to their
home infusion therapy accreditation requirements or survey process that
were not determined nor deemed by CMS to be comparable to the
applicable Medicare requirements.
We propose at Sec. 488.1030(d) to permit CMS to initiate an
accreditation program review when a comparability or performance review
reveals evidence that a home infusion therapy AO's CMS-approved home
infusion therapy accreditation program is in substantial non-compliance
with the requirements of the proposed home infusion therapy health and
safety regulations contained in 42 CFR part 486, subpart B. Proposed
Sec. 488.1030(d)(1) would require CMS to provide written notice to the
home infusion therapy AO when a home infusion therapy accreditation
program review is initiated. Proposed Sec. 488.1030(d)(1)(i) through
(iv) would set forth the requirements for this written notice, which
should contain the following information: (i) A statement of the
instances, rates or patterns of non-compliance identified, as well as
other related information, if applicable; (ii) a description of the
process to be followed during the review, including a description of
the opportunities for the home infusion therapy AO to offer factual
information related to CMS' findings; (iii) a description of the
possible actions that may be imposed by CMS based on the findings of
the accreditation program review; and, (iv) the actions the home
infusion therapy AO would have to take to address the identified
deficiencies, and the length of the accreditation program review
probation period, which will include monitoring of the home infusion
therapy AO's performance and implementation of the corrective action
plan. The probation period is not to exceed 180 calendar days from the
date that CMS has approved the home infusion therapy AOs plan of
correction (which is the AO written plan for correcting any
deficiencies in its home infusion therapy accreditation program that
were found by CMS on a program review).
At Sec. 488.1030(d)(2), we propose that CMS would review and
approve the home infusion therapy AO's plan of correction for
acceptability within 30 days after receipt. Proposed Sec.
488.1030(d)(3) would provide that CMS will monitor the implementation
of the home infusion therapy accrediting organization's plan of
correction for a period not to exceed 180 days from the date of
approval. During the 180-day review period, CMS would monitor
implementation of the accepted plan of correction as well as progress
towards correction of identified issues and areas of non-compliance
that triggered the accreditation program review.
We propose at Sec. 488.1030(d)(4) to authorize CMS to place the
home infusion therapy AO's CMS-approved accreditation program on
probation for a subsequent period of up to 180 calendar days, if
necessary. The additional period of time may be necessary if CMS
determines, as a result of the home infusion therapy accreditation
program review or a review of an application for renewal of an existing
CMS-approved accreditation program, that the home infusion therapy AO
has failed to meet any of the requirements of Sec. 488.1010, or has
made significant progress correcting identified issues or areas of non-
compliance, but requires additional time to complete full
implementation of corrective actions or demonstrate sustained
compliance. If a home infusion therapy AO's term of approval expires
before the 180-day period is completed, the probationary period will be
deemed to end upon the day of expiration of the home infusion therapy
AO's term of approval. In the case of a renewal application where we
have placed the home infusion therapy accreditation program on
probation, we propose that any approval of the applications must be
conditional while the program remains on probation.
If we place a home infusion therapy AO's accreditation program on
probation, proposed Sec. 488.1030(d)(4)(i) would require CMS to issue
a written determination to the home infusion therapy AO, within 60
calendar days after the end of any probationary period. The written
determination must state whether or not the CMS-approved home infusion
therapy accreditation program continued to meet the requirements of
this section and the reasons for the determination.
If we determined that withdrawal of approval from a CMS-approved
accreditation program was necessary, proposed Sec. 488.1030(d)(4)(ii)
would require CMS to send written notice to the home infusion therapy
AO which contained the following information: (1) Notice of CMS'
removal of approval of the home infusion therapy AOs accreditation
program;(2) the reason(s) for the removal; and (3) the effective date
of the removal determined in accordance with Sec. 488.1030(d)(4)(ii).
If CMS withdrew the approval of a home infusion therapy AO
accreditation program, proposed Sec. 488.1030(d)(4)(iii) would require
CMS to publish a notice of its decision to withdraw approval of the
accreditation program in the Federal Register. This notice would have
to include the reasons for the withdrawal, and a notification that the
withdrawal would become effective 60 calendar days after the date of
publication in the Federal Register. The publication of this Federal
Register Notice is notice would be necessary to put interested
stakeholders, such as the home infusion therapy suppliers that are
accredited by the affected AO on notice about the withdrawal of CMS-
approval of their AO, because this will have an effect on the status of
their accreditation.
Proposed Sec. 488.1030(e) would allow CMS to immediately withdraw
the CMS approval of an home infusion therapy AO's home infusion therapy
accreditation program, if at any time CMS makes a determination that
the continued approval of that home infusion therapy accreditation
program poses an immediate jeopardy to the patients of the entities
accredited under the program; or the continued approval otherwise
constitutes a significant hazard to the public health. We propose at
Sec. 488.1030(f) to mandate that any home infusion therapy AO whose
CMS approval of its home infusion therapy accreditation program has
been
[[Page 32462]]
withdrawn must notify, in writing, each of its accredited home infusion
therapy suppliers of the withdrawal of CMS approval and the
implications for the home infusion therapy suppliers' payment status no
later than 30 calendar days after the notice is published in the
Federal Register. This requirement would protect the home infusion
therapy suppliers that have received their accreditation from a home
infusion therapy AO that has had its CMS approval of their home
infusion therapy accreditation program removed.
We seek public comments on the requirements of proposed Sec.
488.1030. We further seek public comment related to the burden
associated with the requirements of proposed Sec. 488.1030.
(8) Ongoing Responsibilities of a CMS-Approved Accreditation
Organization (Sec. 488.1035)
Proposed Sec. 488.1035 would require a home infusion therapy AO to
provide certain information to CMS and carry out certain activities on
an ongoing basis. More specifically proposed Sec. 488.1035(a) would
require the home infusion therapy AO to provide CMS with all of the
following in written format (either electronic or hard copy):
Copies of all home infusion therapy accreditation surveys,
together with any survey-related information that CMS may require
(including corrective action plans and summaries of findings with
respect to unmet CMS requirements);
Notice of all home infusion therapy accreditation
decisions.
Notice of all complaints related to home infusion therapy
suppliers.
Information about all home infusion therapy accredited
suppliers against which the home infusion therapy AO has taken remedial
or adverse action, including revocation, withdrawal, or revision of the
home infusion therapy supplier's accreditation.
Summary data specified by CMS that relate to the past
year's home infusion therapy accreditation activities and trends which
is to be provided on an annual basis.
Notice of any proposed changes in its home infusion
therapy accreditation standards or requirements or survey process.
Proposed Sec. 488.1035(b) would require a home infusion therapy AO
to submit an acknowledgment of receipt of CMS' notification of a change
in CMS requirements within 30 days from the date of the notice.
Proposed Sec. 488.1035(c) would require that a home infusion therapy
AO permit its surveyors to serve as witnesses if CMS takes an adverse
action based on accreditation findings.
Proposed Sec. 488.1035(d) would require that within 2 business
days of identifying a deficiency of an accredited home infusion therapy
supplier that poses immediate jeopardy to a beneficiary or to the
general public, the home infusion therapy AO must provide CMS with
written notice of the deficiency and any adverse action implemented by
the home infusion therapy AO. Proposed Sec. 488.1035(e) would require
that within 10 calendar days after our notice to a CMS-approved home
infusion therapy AO that CMS intends to withdraw approval of the home
infusion therapy AO, the home infusion therapy AO must provide written
notice of the withdrawal to all of the organization's accredited home
infusion therapy suppliers.
We seek public comment on the requirements of proposed Sec.
488.1035. We further seek public comments related to the burden
associated with the requirements of proposed Sec. 488.1035.
(9) Onsite Observations of Accrediting Organization Operations (Sec.
488.1040)
We propose at Sec. 488.1040(a) and (b) to permit CMS to conduct an
onsite inspection of the home infusion therapy AOs operations and
offices at any time to verify the organization's representations and to
assess the organization's compliance with its own policies and
procedures. Activities to be performed by CMS staff during the onsite
inspections may include, but are not limited to: (1) Interviews with
various home infusion therapy AO staff; (2) review of documents, and
survey files, audit tools and related records; (3) observation of
meetings concerning the accreditation process; (4) auditing meetings
concerning the accreditation process, (5) observation of in-progress
surveys and audits; (6) evaluation of the home infusion therapy AO's
survey results and accreditation decision-making process.
CMS would perform onsite visits to a home infusion therapy AOs
offices only for specific reasons. For example, when an AO had filed an
initial or renewal application for approval of its home infusion
therapy accreditation program, CMS would perform an onsite visit to the
AOs offices as part of the application review process. If CMS has
opened a program review and put the home infusion therapy AO on
probation for a 180 day period, we would perform an onsite visit to the
AOs offices to check of the AOs progress in implementing the plan of
correction.
If CMS decides to perform on onsite visit to the home infusion
therapy AOs offices, we would notify the AO. We would coordinate with
the AO staff to schedule the onsite visit at mutually agreed upon date
and time.
The intended purpose of this section is to provide CMS with an
opportunity to observe, first hand, the daily operations of home
infusion therapy AOs and to ensure that the home infusion therapy
accreditation program is fully implemented and operational as presented
in the written application. Onsite inspections would strengthen our
continuing oversight of the home infusion therapy AO performance
because they provide an opportunity for us to corroborate the verbal
and written information submitted to CMS by the home infusion therapy
AO in their initial and renewal applications. In addition, onsite
inspections would allow CMS to assess the home infusion therapy AO's
compliance with its own policies and procedures.
We seek public comments on the requirements of proposed Sec.
488.1040. We also seek comments regarding the burden related to Sec.
488.1040.
(10) Voluntary and Involuntary Termination (Sec. 488.1045)
The proposed provisions related to the voluntary and involuntary
termination of CMS approval of a home infusion therapy AO's
accreditation program are set out at proposed Sec. 488.1045. Proposed
Sec. 488.1045(a) would address voluntary termination of a home
infusion therapy AO's accreditation program by the home infusion
therapy AO. A home infusion therapy AO that decides to voluntarily
terminate its CMS-approved accreditation program must provide written
notice to CMS and each of its accredited home infusion therapy
suppliers at least 90 days in advance of the effective date of the
termination. This written notice must state the implications for the
home infusion therapy supplier's payment should there be a lapse in
their accreditation status.
Proposed standard Sec. 488.1045(b) would address CMS involuntary
termination of a home infusion therapy AO's CMS-approved accreditation
program. Once CMS publishes the notice in the Federal Register
announcing its decision to terminate the accrediting organization's
home infusion therapy accreditation program, the home infusion therapy
AO would have to provide written notification to all home infusion
therapy suppliers accredited under its CMS-approved home infusion
therapy accreditation program no later than 30 calendar days after the
notice was published in the Federal Register. This notice would state
that CMS is withdrawing its
[[Page 32463]]
approval of the home infusion therapy AO's accreditation program and
the implications for their payment, should there be a lapse in their
accreditation status.
Proposed Sec. 488.1045(c) addresses the requirements that would
apply to both voluntary and involuntary terminations of CMS approval of
the home infusion therapy AO. Proposed Sec. 488.1045(c)(1) would
provide that the accreditation status of affected home infusion therapy
suppliers would be considered to remain in effect until their current
term of accreditation expired. In the case where a home infusion
therapy AO has been removed as a CMS-approved AO, any home infusion
therapy supplier that is accredited by the organization during the
period beginning on the date the organization was approved by CMS until
the date the organization was removed, shall be considered accredited
for its remaining accreditation period.
Proposed Sec. 488.1045(c)(2) would provide that for any home
infusion therapy supplier, whose home infusion therapy AO's CMS
approval has been voluntarily or involuntarily terminated by CMS, and
who wishes to continue to receive reimbursement from Medicare, must
provide written notice to CMS at least 60-calendar days prior to its
accreditation expiration date which states that the home infusion
therapy supplier has submitted an application for accreditation under
another CMS-approved home infusion therapy accreditation program. This
section further states that failure to comply with this 60-calendar day
requirement prior to expiration of their current accreditation status
could result in a suspension of payment.
Proposed Sec. 488.1045(c)(3) would require that the terminated
home infusion therapy AO must provide a second written notification to
all accredited suppliers ten calendar days prior to the organization's
accreditation program effective date of termination.
The proposed notice provisions at Sec. 488.1045(c)(2) and (3)
could help prevent home infusion therapy suppliers from suffering
financial hardship that could result from a denial of payment of
Medicare claims if their home infusion therapy accreditation lapses as
a result of the voluntary or involuntary termination of a CMS-approved
home infusion therapy AO program.
We propose at Sec. 488.1045(d), that if a home infusion therapy
supplier requests a voluntary withdrawal from accreditation, it will
not be possible for the withdrawal to become effective until the home
infusion therapy AO completes three required steps. First, the AO would
have to contact the home infusion therapy supplier to seek written
confirmation that the home infusion therapy supplier intended to
voluntarily withdraw from the accreditation program. Second, the home
infusion therapy AO would have to advise home infusion therapy
supplier, in writing, of the statutory requirement at
1861(iii)(3)(D)(i)(III) of the Act for requiring accreditation for all
home infusion therapy suppliers. Third, the home infusion therapy AO
would have to advise the home infusion therapy supplier of the possible
payment consequence for a lapse in accreditation status. Proposed Sec.
488.1045(d)(3) would require the home infusion therapy AO to submit
their final notice of the voluntary withdrawal of accreditation by the
home infusion therapy supplier five business days after the request for
voluntary withdrawal was ultimately processed and effective.
We believe that it is important that the home infusion therapy seek
confirmation that the home infusion therapy supplier has indeed
requested a voluntary termination of their accreditation. This
confirmation would prevent the erroneous termination of the
accreditation of a home infusion therapy supplier that did not request
it or had subsequently withdrawn their request for voluntary
termination.
We believe that it is also important for the home infusion therapy
AO to provide the required written notice to the home infusion therapy
supplier that requests a voluntary withdrawal from accreditation, so
that the home infusion therapy supplier has been fully informed of the
requirements for accreditation according to section
1861(iii)(3)(D)(i)(III) and the payment consequences of being
unaccredited. If there is a lapse in the accreditation status of the
home infusion therapy supplier, they will not be eligible to receive
payment from Medicare for services furnished to Medicare beneficiaries.
A home infusion therapy infusion therapy supplier that is unaware of
this payment consequence could suffer financial hardship due to
furnishing services to Medicare beneficiaries for which they cannot be
reimbursed after a lapse in accreditation.
We seek public comments on the requirements of proposed Sec.
488.1045. We also seek comments regarding the burden related to Sec.
488.1045.
(11) Reconsideration (Sec. 488.1050)
We propose at Sec. 488.1050 to set forth the appeal process
through which a home infusion therapy AO may request reconsideration of
an unfavorable decision made by CMS. At proposed Sec. 488.1050(b)(1),
the home infusion therapy AO would have to submit a written request for
reconsideration within 30 calendar days of the receipt of the CMS
notification of an adverse determination or non-renewal. Proposed Sec.
488.1050(b)(2) would require the home infusion therapy AOs to submit a
written request for reconsideration which specifies the findings or
issues with which the home infusion therapy AO disagreed and the
reasons for the disagreement. Proposed Sec. 488.1050(b)(3) would allow
a home infusion therapy AO to withdraw their request for
reconsideration at any time before the administrative law judge issues
a decision.
We propose at Sec. 488.1050(c)(1) to establish requirements for
CMS when a request for reconsideration has been received from a home
infusion therapy AO. Specifically, CMS would be required to provide the
home infusion therapy AO with: The opportunity for an administrative
hearing with a hearing officer appointed by the Administrator of CMS;
the opportunity to present, in writing and in person, evidence or
documentation to refute CMS' notice of denial, termination of approval,
or non-renewal of CMS approval and designation. Section 488.1050(c)(2)
would require CMS to send the home infusion therapy AO written notice
of the time and place of the informal hearing at least 10 business days
before the scheduled hearing date.
We propose at Sec. 488.1050(d)(1) to establish rules for the
administrative hearing such as who may attend the hearing on behalf of
each party, including but not limited to legal counsel, technical
advisors, and non-technical witnesses that have personal knowledge of
the facts of the case. This proposed section would also specify the
type of evidence that may be introduced at the hearing. Specifically,
we would specify and clarify, at proposed Sec. 488.1050(d)(4), that
the hearing officer would not have the authority to compel by subpoena
the production of witnesses, papers, or other evidence. Proposed Sec.
488.1050(d)(5) would provide that the legal conclusions of the hearing
officer within 45 calendar days after the close of the hearing.
Proposed Sec. 488.1050(d)(6) would require the hearing officer to
present his or her findings and recommendations in a written report
that includes separately numbered findings of fact. According to
proposed Sec. 488.1050(d)(7), the decision of the hearing officer
would be final.
We seek public comments on the requirements of proposed Sec.
488.1050.
[[Page 32464]]
C. Payment for Home Infusion Therapy Services
1. Proposed Temporary Transitional Payment for Home Infusion Therapy
Services for CYs 2019 and 2020
Section 50401 of the BBA of 2018 (Pub. L. 115-123) amended section
1834(u) of the Act by adding a new paragraph (7) that establishes a
home infusion therapy services temporary transitional payment for
eligible home infusion suppliers for certain items and services
furnished in coordination with the furnishing of transitional home
infusion drugs beginning January 1, 2019. This temporary payment covers
the cost of the same items and services, as defined in section
1861(iii)(2)(A) and (B) of the Act, and outlined in section IV.A.2 in
this proposed rule, related to the administration of home infusion
drugs. The temporary transitional payment would begin on January 1,
2019 and end the day before the full implementation of the home
infusion therapy benefit on January 1, 2021, as required by section
5012(d) of the 21st Century Cures Act.
a. Transitional Home Infusion Drugs
Section 1834(u)(7)(A)(iii) of the Act defines the term
``transitional home infusion drug'' using the same definition as `home
infusion drug' under section 1861(iii)(3)(C) of the Act, which is a
drug or biological administered intravenously, or subcutaneously for an
administration period of 15 minutes or more, in the home of an
individual through a pump that is an item of DME. However, section
1834(u)(7)(A)(iii) of the Act includes an exception to the definition
of `home infusion drug' if the drug is identified under section
1834(u)(7)(C) of the Act. This provision specifies the HCPCS codes for
the drugs and biologicals covered under the Local Coverage
Determinations (LCDs) for External Infusion Pumps. In addition,
subsequent infusion drug additions to the LCDs and compounded infusion
drugs not otherwise classified, as identified by HCPCS codes J7799 (Not
otherwise classified drugs, other than inhalation drugs, administered
through DME) and J7999 (Compounded drug, not otherwise classified), are
also included in the definition of a `transitional home infusion drug.'
b. Infusion Drug Administration Calendar Day
Section 1834(u)(7)(E)(i) of the Act states that payment to an
eligible home infusion supplier or qualified home infusion therapy
supplier for an infusion drug administration calendar day in the
individual's home refers to payment only for the date on which
professional services, as described in section 1861(iii)(2) of the Act,
were furnished to administer such drugs to such individual. This
includes all such drugs administered to such individual on such day. We
believe this to mean that payment is only for the day on which the
nurse is in the patient's home when an infusion drug is being
administered. As section 1861(iii)(2)(A) of the Act refers to the
professional services, including nursing services, we believe this to
mean skilled services as set out at 42 CFR 409.32. For the professional
services to be necessary for the safe and effective administration of
home infusion drugs, they must be furnished by skilled professionals in
accordance with individual state practice acts. We understand that
there may be professional services furnished that do not occur on a day
the drug is being administered. However, payment for such home infusion
therapy services is built into the single payment for the day on which
the nurse is in the patient's home and the drug is being infused.
Accordingly, under section 1834(u)(7)(D) of the Act, the temporary
transitional payment is set equal to 4 hours of infusion in a
physician's office even though the nurse may be in the patient's home
for a much shorter timeframe. In other words, payment is made only for
the day on which the administration of the infusion drug occurs even if
professional services were furnished on a different day. Therefore, we
propose to define in regulation that payment for an infusion drug
administration calendar day is for the day on which home infusion
therapy services are furnished by skilled professional(s) in the
individual's home on the day of infusion drug administration. The
skilled services provided on such day must be so inherently complex
that they can only be safely and effectively performed by, or under the
supervision of, professional or technical personnel. An infusion drug
administration visit that begins in one calendar day and spans into the
next calendar day would be considered one visit using the date the
visit ended as the service date. We are soliciting comment on the
proposed definition of infusion drug administration calendar day in
regulation, as detailed in section IX of this proposed rule.
c. Eligible Home Infusion Suppliers, Eligible Individuals, and
Relationship to Home Health
Section 1842(u)(7)(F) of the Act defines eligible home infusion
suppliers as suppliers that are enrolled in Medicare as pharmacies that
provide external infusion pumps and external infusion pump supplies,
and that maintain all pharmacy licensure requirements in the State in
which the applicable infusion drugs are administered. This means that
existing DME suppliers that are enrolled as pharmacies that provide
external infusion pumps and supplies are considered eligible home
infusion suppliers, as are potential pharmacy suppliers that enroll and
comply with the Medicare program's supplier standards (found at 42 CFR
424.57(c)) and quality standards to become accredited for furnishing
external infusion pumps and supplies.\97\ Home infusion therapy
services are furnished by eligible home infusion suppliers in the
individual's home to an individual who is under the care of an
applicable provider and where there is a plan of care established and
periodically reviewed by a physician prescribing the type, amount, and
duration of infusion therapy services. In section VI.C.2.f below,
regarding the home infusion therapy benefit for CY 2021 and subsequent
years, we are soliciting comments regarding the interaction between
home infusion therapy services and home health services. However, for
purposes of this proposed temporary transitional payment for home
infusion therapy services for CYs 2019 and 2020, we anticipate the
relationship between home infusion therapy and home health to be as
described in section VI.C.2.f of this proposed rule.
---------------------------------------------------------------------------
\97\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/DMEPOSQuality/DMEPOSQualBooklet-905709.html.
---------------------------------------------------------------------------
d. Payment Categories
As outlined in section 1834(u)(7)(C) of the Act, identified HCPCS
codes for transitional home infusion drugs are assigned to three
payment categories for which a single payment amount will be
established for home infusion therapy services furnished on each
infusion drug administration calendar day. Payment category 1 includes
antifungals and antivirals, uninterrupted long-term infusions, pain
management, inotropic, and chelation drugs. Payment category 2 includes
subcutaneous immunotherapy infusions. Payment category 3 includes
certain chemotherapy drugs. Table 55 provides the complete list of J-
codes associated with the infusion drugs that
[[Page 32465]]
fall within each of the payment categories.
Table 55--Infusion Drug J-Codes Associated With Temporary Transitional
Payment Categories for Home Infusion Therapy Services
------------------------------------------------------------------------
J-Code Drug
------------------------------------------------------------------------
Category 1:
J0133................... Injection, acyclovir, 5 mg.
J0285................... Injection, amphotericin b, 50 mg.
J0287................... Injection, amphotericin b lipid complex,
10 mg.
J0288................... Injection, amphotericin b cholesteryl
sulfate complex, 10 mg.
J0289................... Injection, amphotericin b liposome, 10 mg.
J0895................... Injection, deferoxamine mesylate, 500 mg.
J1170................... Injection, hydromorphone, up to 4 mg.
J1250................... Injection, dobutamine hydrochloride, per
250 mg.
J1265................... Injection, dopamine hcl, 40 mg.
J1325................... Injection, epoprostenol, 0.5 mg.
J1455................... Injection, foscarnet sodium, per 1,000 mg.
J1457................... Injection, gallium nitrate, 1 mg.
J1570................... Injection, ganciclovir sodium, 500 mg.
J2175................... Injection, meperidine hydrochloride, per
100 mg.
J2260................... Injection, milrinone lactate, 5 mg.
J2270................... Injection, morphine sulfate, up to 10 mg.
J2274................... Injection, morphine sulfate, preservative-
free for epidural or intrathecal use, 10
mg.
J2278................... Injection, ziconotide, 1 microgram.
J3010................... Injection, fentanyl citrate, 0.1 mg.
J3285................... Injection, treprostinil, 1 mg.
Category 2:
J1555 JB \98\........... Injection, immune globulin (cuvitru), 100
mg.
J1559 JB................ Injection, immune globulin (hizentra), 100
mg.
J1561 JB................ Injection, immune globulin, (gamunex-c/
gammaked), non-lyophilized (e.g.,
liquid), 500 mg.
J1562 JB................ Injection, immune globulin (vivaglobin),
100 mg.
J1569 JB................ Injection, immune globulin, (gammagard
liquid), non-lyophilized, (e.g., liquid),
500 mg.
J1575 JB................ Injection, immune globulin/hyaluronidase,
(hyqvia), 100 mg immune globulin.
Category 3:
J9000................... Injection, doxorubicin hydrochloride, 10
mg.
J9039................... Injection, blinatumomab, 1 microgram.
J9040................... Injection, bleomycin sulfate, 15 units.
J9065................... Injection, cladribine, per 1 mg.
J9100................... Injection, cytarabine, 100 mg.
J9190................... Injection, fluorouracil, 500 mg.
J9200................... Injection, floxuridine, 500 mg.
J9360................... Injection, vinblastine sulfate, 1 mg.
J9370................... Injection, vincristine sulfate, 1 mg.
------------------------------------------------------------------------
The payment category for subsequent transitional home infusion drug
additions to the LCDs and compounded infusion drugs not otherwise
classified, as identified by HCPCS codes J7799 and J7999, will be
determined by the Medicare administrative contractors.
---------------------------------------------------------------------------
\98\ The JB modifier indicates that the route of administration
is subcutaneous.
---------------------------------------------------------------------------
e. Payment Amounts
As set out at new section 1834(u)(7)(D) of the Act, as added by
section 50401 of the BBA of 2018 (Pub. L. 115-123), each payment
category will be paid at amounts in accordance with the Physician Fee
Schedule for each infusion drug administration calendar day in the
individual's home for drugs assigned to such category without
geographic adjustment. Table 56 provides the payment categories
associated with the HCPCS codes.
Table 56--Payment Categories for Temporary Transitional Payment for Home
Infusion Therapy Services
------------------------------------------------------------------------
HCPCS code Description Units
------------------------------------------------------------------------
Category 1:
96365......................... Therapeutic, Prophylactic, 1
and Diagnostic Injections
and Infusions (Excludes
Chemotherapy and Other
Highly Complex Drug or
Highly Complex Biologic
Agent Administration)--up
to one hour.
96366......................... Therapeutic, Prophylactic, 3
and Diagnostic Injections
and Infusions (Excludes
Chemotherapy and Other
Highly Complex Drug or
Highly Complex Biologic
Agent Administration)--
each additional hour.
Category 2:
96369......................... Therapeutic, Prophylactic, 1
and Diagnostic Injections
and Infusions (Excludes
Chemotherapy and Other
Highly Complex Drug or
Highly Complex Biologic
Agent Administration)--up
to one hour.
96370......................... Therapeutic, Prophylactic, 3
and Diagnostic Injections
and Infusions (Excludes
Chemotherapy and Other
Highly Complex Drug or
Highly Complex Biologic
Agent Administration)--
each additional hour.
Category 3:
[[Page 32466]]
96413......................... Injection and Intravenous 1
Infusion Chemotherapy and
Other Highly Complex Drug
or Highly Complex Biologic
Agent Administration--up
to one hour.
96415......................... Injection and Intravenous 3
Infusion Chemotherapy and
Other Highly Complex Drug
or Highly Complex Biologic
Agent Administration--each
additional hour.
------------------------------------------------------------------------
Section 1834(u)(7)(E)(ii) of the Act requires that in the case that
two (or more) home infusion drugs or biologicals from two different
payment categories are administered to an individual concurrently on a
single infusion drug administration calendar day, one payment for the
highest payment category would be made.
f. Billing
For eligible home infusion suppliers to bill for home infusion
therapy services for an infusion drug administration calendar day, we
will create three new HCPCS G-codes for each of the three payment
categories. The eligible home infusion supplier would submit, in line-
item detail on the claim, a G-code for every visit made by the nurse to
provide professional services to the patient in his/her home on a day
in which a drug is being infused. Each visit reported would include the
length of time in which professional services were provided (in 15
minute increments). However, only one payment would be made per
infusion drug administration calendar day at the standard amount
described by each of the payment categories noted previously, for a
total payment equivalent to 4 hours per infusion drug administration
calendar day. These G-codes could be billed separately from or on the
same claim as the DME, supplies, and infusion drug; and would be
processed through the DME MACs. The supplier furnishing the DME, pump,
the infusion drug, and other supplies must also provide the
professional services under the home infusion therapy benefit during
the temporary transitional payment period.
For the purposes of this temporary transitional payment for home
infusion therapy services, section 1834(u)(7)(D)(i) requires that
payment amounts would be equal to the amounts determined under the
Physician Fee Schedule established under section 1848 of the Act for
services furnished during the year for codes and units for such codes
specified without application of geographic wage adjustment under
section 1848(e) of the Act. In the event that multiple drugs, which are
not all assigned to the same payment category, are administered on the
same infusion drug administration calendar day, section
1834(u)(7)(E)(ii) requires that a single payment would be made that is
equal to the highest payment category. In order to implement the
requirements of section 1834(u)(7) of the Act for this temporary
transitional payment, we would issue a Change Request (CR) prior to
implementation of this temporary transitional payment, including the G-
codes needed for billing, outlining the requirements for the claims
processing changes needed to implement this payment.
2. Solicitation of Public Comments Regarding Payment for Home Infusion
Therapy Services for CY 2021 and Subsequent Years
Upon the expiration of the home infusion therapy services temporary
transitional payment, we would be fully implementing the home infusion
therapy services payment system under section 1834(u)(1) of the Act, as
added by section 5012 of the 21st Century Cures Act (Pub. L. 114-255).
In anticipation of future rulemaking, we are soliciting comments
regarding the payment system for home infusion therapy services
beginning in CY 2021.
a. Relationship to DME
As mentioned previously, Medicare Part B covers certain infusion
pumps and supplies (including certain home infusion drugs) that are
necessary for the effective use of the infusion pump, through the DME
benefit. To be covered under the Part B DME benefit, the drug must be
reasonable and necessary for the treatment of illness or injury or to
improve the function of a malformed body member, and the drug must be
necessary for the effective use of the DME. However, there is no
separate Medicare Part B DME payment for professional services
associated with the administration of home infusion drugs, including
nursing services, or for training and education, monitoring, and remote
monitoring services. Therefore, we consider the home infusion therapy
benefit principally to be a separate payment in addition to the
existing payment made under the DME benefit, thus explicitly and
separately paying for the home infusion therapy services.
b. Definition of Infusion Drug Administration Calendar Day
Section 1834(u)(7)(E)(i) of the Act applies the same definition of
``infusion drug administration calendar day'' for both the home
infusion therapy temporary transitional payment and the home infusion
therapy services benefit. We anticipate retaining the definition of
infusion drug administration calendar day, as proposed in section
IV.C.2. of this proposed rule for the full implementation of the home
infusion therapy services benefit. This means that payment for an
infusion drug administration calendar day is for the day on which home
infusion therapy services are furnished by skilled professionals in the
individual's home on the day of infusion drug administration. An
infusion drug administration visit that begins in one calendar day and
spans into the next calendar day would be considered one visit using
the date the visit ended as the service date. The skilled services
provided on such day must be so inherently complex that they can only
be safely and effectively performed by, or under the supervision of,
professional or technical personnel. We are soliciting comments on the
definition as discussed in section IV.C.2. of this proposed rule.
c. Payment Basis, Limitation on Payment, Required and Discretionary
Adjustments, and Billing Procedures
Section 1834(u)(1)(A) of the Act requires the establishment of a
unit of single payment for each infusion drug administration calendar
day. Section 1834(u)(1)(A)(iii) of the Act limits the unit of single
payment by requiring that it must not exceed the amount determined
under the fee schedule under section 1848 of the Act for infusion
therapy services furnished in a calendar day if furnished in a
physician's office, and the single payment must not reflect more than
five hours for a particular therapy in a calendar day. Additionally,
section 1834(u)(1) of the Act includes provisions for payment
adjustments to
[[Page 32467]]
the unit of single payment for home infusion therapy. Section
1834(u)(1)(B) of the Act requires adjustments to reflect factors such
as patient acuity and complexity of drug administration, and a
geographic wage index and other costs that may vary by region. While
the three payment categories used for the temporary transitional
payment in CYs 2019 and 2020 reflect the therapy type and complexity of
the drug administration under the Physician Fee Schedule, we are
soliciting comments on other ways to account for therapy type and
complexity of administration, as well as ways to capture patient
acuity.
Section 1834(u)(1)(B)(i) of the Act requires that the single
payment amount be adjusted by a geographic wage index; therefore, we
are considering using the Geographic Practice Cost Indices (GPCIs) to
account for regional variations in wages and adjust the payment for the
professional services. A GPCI has been established for every Medicare
payment locality for each of the three components of a procedure's
relative value unit (RVU) (for example, the RVUs for work, practice
expense, and malpractice). The GPCIs are applied in the calculation of
a fee schedule payment amount by multiplying the RVU for each component
times the GPCI for that component.\99\ Finally, section 1834(u)(1)(C)
of the Act allows for discretionary adjustments which may include
outlier situations and other factors as deemed appropriate by the
Secretary, and are required to be made in a budget neutral manner. We
request feedback on situations that may incur an outlier payment and
potential designs for an outlier payment calculation.
---------------------------------------------------------------------------
\99\ https://www.cms.gov/apps/physician-fee-schedule/documentation.aspx.
---------------------------------------------------------------------------
For CY 2021 and subsequent years, although not required by law, the
Part B qualified home infusion therapy supplier could potentially
submit a claim for home infusion therapy services on a Part B
practitioner claim and processed through the A/B MACs, rather than the
DME MACs. We are soliciting comment on whether submitting a Part B
practitioner claim processed through the A/B MACs is reasonable given
that other types of suppliers and providers of services (such as
physicians and HHAs), and not just DME suppliers, can meet the
requirements under section 1861(iii) of the Act, such as accreditation,
to provide home infusion therapy services. In addition, when Part B
practitioner claims are processed through the A/B MACs a mechanism is
already in place for the geographic wage adjustment, as required for
the home infusion therapy payment system, and we are considering the
use of GPCI as described previously. In order to bill for the home
infusion therapy services, beginning on January 1, 2021, a qualified
home infusion therapy supplier will need to enroll in Medicare as a
Part B Home Infusion Therapy supplier. Additionally, in order to
furnish DME equipment and supplies, that same qualified home infusion
therapy supplier must also be enrolled as a DME supplier since the home
infusion therapy services are required to be for the furnishing of DME
infusion drugs through a DME infusion pump. In other words, both
enrollments would be necessary for the same supplier to bill for home
infusion therapy services and the DME equipment and supplies.
Therefore, in order to be paid for all elements of home infusion
therapy, two claims would need to be submitted: (1) The first claim for
the DME drug, equipment, and supplies on the 837P/CMS-1500 professional
and supplier claims form submitted to the DME MAC; and (2) a second
claim for the professional services on the 837P/CMS-1500 professional
and supplier claims form submitted to the A/B MAC.
We invite comments on the unit of single payment, limitations on
payment, and required and discretionary adjustments. We are also
soliciting comments on whether it is reasonable to require two separate
claims submissions to account for all components of home infusion
therapy using the 837P/CMS-1500 professional and supplier claims form,
and submitting claims to both the DME MACs and the A/B MACs for
processing. Finally, we are soliciting any additional suggestions as to
how qualified home infusion therapy suppliers should bill and be paid
for services under the home infusion therapy benefit.
d. Definition of Professional/Nursing Services and Monitoring Related
to the Administration of Home Infusion Drugs
In accordance with section 1861(iii)(2) of the Act, items and
services covered under the home infusion therapy benefit are as
follows:
Professional services, including nursing services,
furnished in accordance with the plan.
Training and education (not otherwise paid for as DME),
Remote monitoring, and monitoring services for the
provision of home infusion drugs furnished by a qualified home infusion
therapy supplier.
Section 1861(n) of the Act defines DME as equipment used in the
patient's home. Furthermore, the regulations at 42 CFR 424.57(c)(12)
state that the DME supplier ``must document that it or another
qualified party has at an appropriate time, provided beneficiaries with
necessary information and instructions on how to use Medicare-covered
items safely and effectively.'' As the medications in the DME external
infusion pump LCDs are considered supplies to the external infusion
pump, and have been identified as drugs and biologicals that can be
self-infused in the home, ongoing nursing supervision is not required
once the patient and/or caregiver has been sufficiently taught to
safely manage the pump. We recognize that the DME supplier standards
require a DME supplier to document that it or another qualified party
has at an appropriate time provided beneficiaries with necessary
information and instructions on how to use Medicare-covered items
safely and effectively (42 CFR 424.57(c)(12)). Therefore, the in-home
nursing services under the home infusion therapy benefit would include
a limited amount of teaching and training on the provision of home
infusion drugs that is not already covered under the DME benefit in
accordance.
In determining the reasonable and necessary number of infusion
therapy visits, the home infusion therapy supplier must consider
whether the training and education provided constitutes reinforcement
of teaching provided previously in an institutional setting or in the
home, or whether it represents initial instruction. Where the teaching
represents initial instruction, the supplier should consider patient
acuity, including the unique abilities of the patient, and complexity
of the infusion. Where the teaching constitutes reinforcement, the
supplier should evaluate the patient's retained knowledge and
anticipated learning progress to determine the appropriate number of
visits. Re-teaching or retraining for an appropriate period may be
considered reasonable and necessary where there is a change in the
infusion protocol or the patient's condition that requires re-teaching,
or where the patient, family, or caregiver is not properly carrying out
the task. The medical record should document the anticipated number of
training and education visits required, patient/caregiver response to
training, and if necessary, the reason that the re-teaching or
retraining is required. Where it becomes apparent after a reasonable
period of time that the patient/caregiver is not able to be trained, or
if the patient/caregiver has been taught to safely and effectively use
the infusion
[[Page 32468]]
pump in the home, then further teaching and training would cease to be
reasonable and necessary. In accordance with section 1861(iii)(1)(B),
an individual must be under a plan of care established by a physician,
prescribing the type, amount, and duration of infusion therapy services
that are to be furnished in coordination with the furnishing of home
infusion drugs under Part B. These home infusion drugs, defined under
section 1861(iii)(3)(C) of the Act, must be administered intravenously,
or subcutaneously for an administration period of 15 minutes or more
through a pump that is an item of DME in order for home infusion
therapy services to be reasonable and necessary for the treatment of
the illness or injury. In order to satisfy the definition of DME, an
item must be appropriate for use in the home. In this case, in order to
be considered appropriate for use in the home, the patient must be able
to safely and effectively operate the infusion pump. Therefore, if a
patient is unable to safely and effectively operate the infusion pump
in the home, then the patient would not be eligible for the home
infusion therapy benefit.
It is important to reiterate that the professional services covered
under this benefit are not intended to provide on-going nursing
supervision throughout each infusion. If applicable, the reason why a
training was unsuccessful should be documented in the record. We invite
comments regarding what constitutes a reasonable and necessary amount
of training and education for the provision of home infusion drugs. We
outline in this section additional, more detailed information on the
professional and nursing services that would be covered, as well as
remote monitoring services for the provision of home infusion drugs, as
defined in 1861(iii)(3)(C) of the Act, relative to the therapy types
currently included in the DME external infusion pump LCD.\100\
---------------------------------------------------------------------------
\100\ https://med.noridianmedicare.com/documents/2230703/7218263/External+Infusion+Pumps+LCD.
---------------------------------------------------------------------------
(1) Central Vascular Access Device Maintenance
As many of the drugs and biologicals included in the DME external
infusion pump LCD are given continuously, given on a long-term basis,
or are vesicants or irritants that should not be given peripherally,
many beneficiaries would likely have central vascular access devices
(CVAD), such as peripherally inserted central catheters (PICC), central
lines, or ports requiring training and education regarding maintenance
and hygiene, and site care and dressing changes. The qualified home
infusion therapy supplier would be responsible for educating the
patient on properly disinfecting access points and connectors, what to
do in the event of a dislodgement or occlusion, and signs/symptoms of
infection. This also includes teaching the patient about flushing the
CVAD after the infusion to ensure all of the medication has been
flushed through the tubing and catheter, and locking the catheter to
prevent blood from backing into the catheter and clotting. Education
regarding specific techniques and solutions (saline or heparin) may be
given to minimize catheter occlusion.\101\
---------------------------------------------------------------------------
\101\ Gabriel J (2013) Venous access devices part 2: preventing
and managing complications of CVADs. Nursing Times; 109: 40, 20-23.
---------------------------------------------------------------------------
(2) Medication Education and Disease Management
The qualified home infusion therapy supplier would be responsible
for ensuring that the patient has been properly educated about his/her
disease, medication therapy, and lifestyle changes. This could include
self-monitoring instruction (for example, nutrition, temperature, blood
pressure, heart rate, daily weight, abdominal girth measurement, edema,
urine output) and identification of complications or problems
necessitating a call to the infusion nurse/pharmacist, or emergency
protocols if they arise. The qualified home infusion therapy supplier
would ensure proper understanding of the medication therapy including:
Drug; route of administration; prescription (dosage, how often to
administer, and duration of therapy); side effects and interactions
with other medications; adverse reactions to therapy; goals of therapy;
and indications of progress. Lifestyle education regarding behavior and
food/fluid modifications/restrictions, symptom management, and
infection control are also important aspects of this education. As some
drugs covered under the DME benefit involve extensive lifestyle changes
and dietary restrictions, training and education as included in the
home infusion therapy benefit could entail any ancillary services such
as visits with social workers or dieticians as needed, and documented
in the medical record. For patients on continuous, potentially life
long IV therapy, the nurse, social worker, or dietician would assess
the need for further training and education regarding the concept of
long-term drug infusion and address aspects of life-style changes and
realistic expectations for life with an infusion pump.
(3) Patient Evaluation and Assessment
Comprehensive patient assessment is imperative when providing home
infusion therapy in order to ensure the accuracy of the medication
administration and safety of the patient, and to determine whether
changes in the home infusion therapy plan of care are necessary. The
qualified home infusion therapy supplier would evaluate patient
history, current physical and mental status, including patient response
to therapy, any adverse effects or infusion complications, lab reports,
cognitive and psychosocial status, family/care partner support,
prescribed treatment, concurrent oral prescriptions, and over-the-
counter medications. This includes obtaining any necessary blood-work
and vital signs.
(4) Medication Administration
As the DME supplier is responsible, under the DME benefit,\102\ for
training the patient and caregiver on pump operation, maintenance, and
troubleshooting; the qualified home infusion therapy supplier would be
responsible for all other aspects of medication administration,
including inspection of medications, containers, supplies prior to use;
proper drug storage and disposal; household precautions for
chemotherapy drugs including spills, handling body wastes, and physical
contact precautions; hand hygiene and aseptic technique; pre/post
medication/hydration administration; and medication preparation.
---------------------------------------------------------------------------
\102\ https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/downloads/DMEPOSAccreditationStandardsCMB.pdf.
---------------------------------------------------------------------------
(5) Remote Monitoring and Monitoring Services
Section 1861(iii)(3)(D)(i)(II) of the Act requires that the
qualified home infusion therapy supplier ``ensures the safe and
effective provision and administration of home infusion therapy on a 7-
day-a-week, 24-hour-a-day basis.'' Therefore, the qualified home
infusion therapy supplier would closely monitor lab values, patient
response to therapy, and assess compliance. Direct communication and
coordination with the patient, caregivers, applicable providers, and
pharmacist regarding changes in the patient's condition should be on-
going so that any adjustment to treatment is made as needed and in a
timely fashion.
Monitoring services, as indicated on the plan of care, would
dictate either the
[[Page 32469]]
need for daily monitoring of indicated vitals (through remote
monitoring) or specify the interval for in-person evaluation and
assessment of the patient. The use of remote monitoring services for
those patients receiving home infusion therapy would likely be limited
to patients receiving continuous infusion medications as identified in
the plan of care. These patients are considered high risk patients and
require daily monitoring, but generally do not need to be seen by a
practitioner daily. This can be achieved, for example, through the use
of a remote monitoring service that includes monitoring equipment
through which the patient electronically submits self-obtained vital
signs, such as weight, blood pressure, and heart rate. In this example,
an off-site monitoring service would communicate any abnormal results
to the home infusion therapy supplier for analysis and consultation
with the provider overseeing the patient's care (that is, physician,
nurse practitioner, or physician assistant) regarding potential
treatment plan changes.
We invite comments on any additional interpretations of
professional, nursing, training and education, and monitoring services
that may be considered under the scope of the home infusion therapy
benefit. We also specifically welcome comments on the use of remote
monitoring under the home infusion therapy benefit.
e. The Role of Prior Authorization Under the Home Infusion Therapy
Benefit
Section 1834(u)(4) of the Act states that the Secretary may apply
prior authorization for home infusion services. Generally, prior
authorization requires that a decision by a health insurer or plan be
rendered to confirm that a health care service, treatment plan,
prescription drug or durable medical equipment is medically
necessary.\103\ Prior authorization helps to ensure that a service,
such as home infusion therapy, is being provided appropriately. Private
health plans generally require prior authorization before home infusion
therapy can begin. We would maintain the discretion to decide if
certain drugs or frequency in visits require prior authorization before
therapy can be covered. The emphasis would be on the appropriateness of
the drug and the necessity of associated professional services and not
the site of care. We are soliciting comments as to whether and how
prior authorization could potentially be utilized for home infusion
therapy.
---------------------------------------------------------------------------
\103\ https://www.healthcare.gov/glossary/preauthorization/.
---------------------------------------------------------------------------
f. Home Infusion Therapy and the Relationship to/Interaction With Home
Health
A beneficiary does not have to be considered confined to the home
(that is, homebound) in order to be eligible for the home infusion
therapy benefit. However, homebound beneficiaries requiring home health
services also may be eligible for the home infusion therapy benefit.
Therefore, there may be circumstances when a patient may utilize both
the home health benefit and the home infusion therapy benefit
concurrently.
HHAs are required to furnish necessary DME and coordinate home
infusion services when a patient is under a home health plan of care.
In accordance with the Home Health Conditions of Participation at 42
CFR 484.60, the HHA must assure communication with all physicians
involved in the plan of care, as well as integrate orders and services
provided by all physicians and disciplines. In order to qualify for the
Medicare home health benefit, the beneficiary must--
Be confined to the home;
Be under the care of a physician;
Receive services under a plan of care established and
periodically reviewed by a physician;
Be in need of skilled nursing care on an intermittent
basis or physical therapy or speech-language pathology, or have a
continuing need for occupational therapy; and
Have had a face-to-face encounter related to the primary
reason for home health care with an allowed provider type and within
the required timeframe.
If a patient meets the requirements listed previously and a home
health visit is furnished that is unrelated to home infusion therapy,
then payment for the home health visit would be covered by the HH PPS
payment and billed on the home health claim. When the HHA providing
services under the Medicare home health benefit is also the same entity
furnishing services as the qualified home infusion therapy supplier,
and a home visit is exclusively for the purpose of furnishing items and
services related to home infusion therapy, the HHA would submit a claim
for payment as a home infusion therapy supplier and receive payment
under the home infusion therapy benefit. If the home visit includes the
provision of other home health services in addition to, and separate
from, items and services related to the home infusion therapy, the HHA
would submit both a home health claim and a home infusion therapy
claim, but must separate the time spent performing services covered
under the HH PPS from the time spent performing services covered under
the home infusion therapy benefit. We anticipate this would be similar
to the approach for furnishing negative pressure wound therapy using a
disposable device as described in the regulations at 42 CFR 484.205(b).
We are soliciting feedback on the relationship between the Medicare
home health benefit and the home infusion therapy benefit, including
how payment would be made for a beneficiary who meets eligibility
requirements for home health services and home infusion therapy
services.
VII. Changes to the Accreditation Requirements for Certain Medicare-
Certified Providers and Suppliers
A. Background
To participate in the Medicare program, Medicare-certified
providers and suppliers of health care services, must be substantially
in compliance with specified statutory requirements of the Act, as well
as any additional regulatory requirements related to the health and
safety of patients specified by the Secretary of the Department of
Health and Human Services (HHS). Medicare certified providers and
suppliers are enrolled in the Medicare program by entering into an
agreement with Medicare. They include hospitals, skilled nursing
facilities, home health agencies, hospice programs, rural health
clinics, critical access hospitals, comprehensive outpatient
rehabilitation facilities, laboratories, clinics, rehabilitation
agencies, public health agencies, and ambulatory surgical centers.
These health and safety requirements are generally called conditions of
participation (CoPs) for most providers, requirements for skilled
nursing facilities (SNFs), conditions for coverage (CfCs) for
ambulatory surgical centers (ASCs) and other suppliers, and conditions
for certification for rural health clinics (RHCs). A Medicare-certified
provider or supplier that does not substantially comply with the
applicable health and safety requirements risks having its
participation in the Medicare program terminated.
In accordance with section 1864 of the Act, state health
departments or similar agencies, under an agreement with CMS, survey
health care providers and suppliers to ascertain compliance with the
applicable CoPs, CfCs, conditions of certification, or requirements,
and certify their findings to us. Based on these State Survey
[[Page 32470]]
Agency (SA) certifications, we determine whether the provider or
supplier qualifies, or continues to qualify, for participation in the
Medicare program.
Section 1865(a) of the Act allows most health care facilities to
demonstrate compliance with Medicare CoPs, requirements, CfCs, or
conditions for certification through accreditation by a CMS-approved
program of a national accreditation body. If an AO is recognized by the
Secretary as having standards for accreditation that meet or exceed
Medicare requirements, any provider or supplier accredited by the AO's
CMS-approved accreditation program may be deemed by us to meet the
Medicare conditions or requirements.
We are responsible for the review, approval and subsequent
oversight of national AOs' Medicare accreditation programs, and for
ensuring providers or suppliers accredited by the AO meet the quality
and patient safety standards required by the Medicare CoPs,
requirements, CfCs, and conditions for certification. Any national AO
seeking approval of an accreditation program in accordance with section
1865(a) of the Act must apply for and be approved by CMS for a period
not to exceed six years.
The AO must reapply for renewed CMS approval of an accreditation
program before the date its approval period expires. This allows
providers or suppliers accredited under the program to continue to be
deemed to be in compliance with the applicable Medicare CoPs,
requirements, CfCs, and conditions for certification. Regulations
implementing these provisions are found at 42 CFR 488.1 through 488.9.
We believe that it is necessary to revise the regulations for
Medicare-certified providers and providers to add two new requirements
for the AOs that accredit certified providers and providers. First, we
are proposing at Sec. 488.5 to require AOs for Medicare-certified
providers and suppliers to include a written statement in their
application which states that if a fully accredited and deemed facility
in good standing provides written notification that they wish to
voluntarily withdraw from the AO's CMS-approved accreditation program,
the AO must continue the facility's current accreditation until the
effective date of withdrawal identified by the facility or the
expiration date of the term of accreditation, whichever comes first. We
are also proposing to modify the AO oversight regulations at Sec.
488.5 by adding new requirements for training for AO surveyors.
B. Proposed Changes to Certain Requirements for Medicare-Certified
Providers and Suppliers at Part 488
1. Continuation of Term of Accreditation When a Medicare-Certified
Provider or Supplier Decides to Voluntarily Terminate the Services of
an Accrediting Organization (Sec. 488.5)
We propose to add a new regulation at Sec. 488.5(a)(17)(iii),
which would require that, with an initial or renewal application for
CMS-approval of a Medicare certified provider or supplier accreditation
program, an AO must include a written statement agreeing that when a
fully accredited, deemed provider or supplier in good standing notifies
its AO that it wishes to voluntarily withdraw from the AO's
accreditation program, the AO would honor the provider's or supplier's
current term of accreditation until the effective date of withdrawal
identified by the facility, or the expiration date of the term of
accreditation, whichever comes first. We make this proposal because we
have received numerous complaints from accredited and deemed facilities
in good standing with their current AO stating that once they provide
notification to the AO of their intent to voluntary withdrawal their
accreditation from that AO, the AO frequently terminates their
accreditation immediately without regard to their current accreditation
status, up to date payment of fees, contract status, or the facility's
requested effective date of withdrawal. Accreditation is voluntary for
Medicare certified providers and suppliers that participate in
Medicare. It is not required for participation in Medicare. Therefore,
we do not believe it is reasonable for AOs to penalize facilities
because they choose to terminate the services of an AO. Medicare
certified providers and suppliers may freely choose to demonstrate
compliance with the Medicare conditions.by receiving surveys from any
CMS-approved AO of their choice, or the SA.
2. Training Requirements for Accrediting Organization Surveyors (Sec.
488.5(a)(7))
We are proposing to add a new requirement at Sec. 488.5(a)(7)
which imposes a new training requirement for surveyors of AO that
accredit Medicare certified provider and supplier types by amending the
provision at Sec. 488.5(a)(7). We are proposing that all AO surveyors
be required to complete the relevant program-specific CMS online
trainings initially, and thereafter, consistent with requirements
established by CMS for state surveyors. CMS provides a wide variety of
comprehensive trainings through an on-demand integrated surveyor
training website. These online trainings are available and can be
accessed by state and federal surveyors and the public, free of charge,
24 hours a day, 365 days a year. These online trainings are currently
publically available for the SA surveyors.
As part of our oversight of the AOs performance, CMS has contracted
with the SAs to perform validation surveys on a sample of providers and
suppliers (such as hospitals, critical access hospital, ambulatory
surgical centers, and home health agencies) accredited by the AOs that
accredit Medicare certified providers and suppliers. Validation surveys
must be performed by the SA within 60 days of the survey performed by
the AO. As a validation survey is performed within 60 days of the AO
survey, we believe that the conditions at the hospital or other
facility being surveyed would be similar at the time of the validation
survey.
The purpose of a validation survey is to compare the survey
findings of the AO to the survey findings of the SA to see if there are
any disparities. The amount of disparities found in the AO's survey is
called the ``disparity rate'' and is tracked by CMS as an indication of
the quality of the surveys performed by the AO.
CMS has determined that many of the AOs' disparity rates have been
consistently high. This means that the AOs have consistently failed to
find the same condition level deficiencies in the care provided by the
hospital or other providers surveyed that were found by the SA during
the validation survey.
We believe that the disparity in findings made by the AO surveyors
and those of the SA surveyors can largely be attributed the difference
in the training and education provided to the AO surveyors. Each AO is
responsible for providing training and education to their surveyors.
The surveyor training and education provided varies from AO to AO and
is not consistent. CMS provides comprehensive online training to the SA
surveyor staff on the CMS Surveyor Training website \104\ which are
specific to each type of provider of supplier type to be surveyed.
---------------------------------------------------------------------------
\104\ https://surveyortraining.cms.hhs.gov/.
---------------------------------------------------------------------------
It is our belief that the AO's disparity rate would be decreased if
all surveyors took the same training. We believe completion of the same
surveyor training by both SA and AO surveyors would increase the
consistency between the results of the surveys performed by the SAs and
AOs and have a positive impact on the historically high disparity
[[Page 32471]]
rate. Therefore we are proposing that all AO surveyors be required to
take the CMS online surveyor training offered on the CMS website. We
would require each AO to provide CMS with documentation which provides
proof that each of their surveyors has completed the CMS online
surveyor training. If the AO fails to provide this documentation, CMS
could place the AO on an accreditation program review pursuant to Sec.
488.8(c).
VIII. Requests for Information
This section addresses two requests for information (RFI). Upon
reviewing the RFIs, respondents are encouraged to provide complete but
concise responses. These RFIs are issued solely for information and
planning purposes; neither RFI constitutes a Request for Proposal
(RFP), application, proposal abstract, or quotation. The RFIs do not
commit the U.S. Government to contract for any supplies or services or
make a grant award. Further, CMS is not seeking proposals through these
RFIs and will not accept unsolicited proposals. Responders are advised
that the U.S. Government will not pay for any information or
administrative costs incurred in response to these RFIs; all costs
associated with responding to these RFIs will be solely at the
interested party's expense. Failing to respond to either RFI will not
preclude participation in any future procurement, if conducted. It is
the responsibility of the potential responders to monitor each RFI
announcement for additional information pertaining to the request.
Please note that CMS will not respond to questions about the policy
issues raised in these RFIs. CMS may or may not choose to contact
individual responders. Such communications would only serve to further
clarify written responses. Contractor support personnel may be used to
review RFI responses. Responses to these RFIs are not offers and cannot
be accepted by the U.S. Government to form a binding contract or issue
a grant. Information obtained as a result of these RFIs may be used by
the U.S. Government for program planning on a non-attribution basis.
Respondents should not include any information that might be considered
proprietary or confidential. This RFI should not be construed as a
commitment or authorization to incur cost for which reimbursement would
be required or sought. All submissions become U.S. Government property
and will not be returned. CMS may publically post the comments
received, or a summary thereof.
A. Request for Information on Promoting Interoperability and Electronic
Healthcare Information Exchange Through Possible Revisions to the CMS
Patient Health and Safety Requirements for Hospitals and Other
Medicare- and Medicaid-Participating Providers and Suppliers
Currently, Medicare- and Medicaid-participating providers and
suppliers are at varying stages of adoption of health information
technology (health IT). Many hospitals have adopted electronic health
records (EHRs), and CMS has provided incentive payments to eligible
hospitals, critical access hospitals (CAHs), and eligible professionals
who have demonstrated meaningful use of certified EHR technology
(CEHRT) under the Medicare EHR Incentive Program. As of 2015, 96
percent of Medicare- and Medicaid-participating non-Federal acute care
hospitals had adopted certified EHRs with the capability to
electronically export a summary of clinical care.\105\ While both
adoption of EHRs and electronic exchange of information have grown
substantially among hospitals, significant obstacles to exchanging
electronic health information across the continuum of care persist.
Routine electronic transfer of information post-discharge has not been
achieved by providers and suppliers in many localities and regions
throughout the Nation.
---------------------------------------------------------------------------
\105\ These statistics can be accessed at:
https://dashboard.healthit.gov/quickstats/pages/FIG-Hospital-EHR-Adoption.php.
---------------------------------------------------------------------------
CMS is firmly committed to the use of certified health IT and
interoperable EHR systems for electronic healthcare information
exchange to effectively help hospitals and other Medicare- and
Medicaid-participating providers and suppliers improve internal care
delivery practices, support the exchange of important information
across care team members during transitions of care, and enable
reporting of electronically specified clinical quality measures
(eCQMs). The Office of the National Coordinator for Health Information
Technology (ONC) acts as the principal Federal entity charged with
coordination of nationwide efforts to implement and use health
information technology and the electronic exchange of health
information on behalf of the Department of Health and Human Services.
In 2015, ONC finalized the 2015 Edition health IT certification
criteria (2015 Edition), the most recent criteria for health IT to be
certified to under the ONC Health IT Certification Program. The 2015
Edition facilitates greater interoperability for several clinical
health information purposes and enables health information exchange
through new and enhanced certification criteria, standards, and
implementation specifications. CMS requires eligible hospitals and CAHs
in the Medicare and Medicaid EHR Incentive Programs and eligible
clinicians in the Quality Payment Program (QPP) to use EHR technology
certified to the 2015 Edition beginning in CY 2019.
In addition, several important initiatives will be implemented over
the next several years to provide hospitals and other participating
providers and suppliers with access to robust infrastructure that will
enable routine electronic exchange of health information. Section 4003
of the 21st Century Cures Act (Pub. L. 114-255), enacted in 2016, and
amending section 3000 of the Public Health Service Act (42 U.S.C.
300jj), requires HHS to take steps to advance the electronic exchange
of health information and interoperability for participating providers
and suppliers in various settings across the care continuum.
Specifically, Congress directed that ONC ``. . . for the purpose of
ensuring full network-to-network exchange of health information,
convene public-private and public-public partnerships to build
consensus and develop or support a trusted exchange framework,
including a common agreement among health information networks
nationally.'' In January 2018, ONC released a draft version of its
proposal for the Trusted Exchange Framework and Common Agreement,\106\
which outlines principles and minimum terms and conditions for trusted
exchange to enable interoperability across disparate health information
networks (HINs). The Trusted Exchange Framework (TEF) is focused on
achieving the following four important outcomes in the long-term:
---------------------------------------------------------------------------
\106\ The draft version of the trusted Exchange Framework may be
accessed at: https://beta.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement.
---------------------------------------------------------------------------
Professional care providers, who deliver care across the
continuum, can access health information about their patients,
regardless of where the patient received care.
Patients can find all of their health information from
across the care continuum, even if they do not remember the name of the
professional care provider they saw.
Professional care providers and health systems, as well as
public and private health care organizations and public and private
payer organizations
[[Page 32472]]
accountable for managing benefits and the health of populations, can
receive necessary and appropriate information on groups of individuals
without having to access one record at a time, allowing them to analyze
population health trends, outcomes, and costs; identify at-risk
populations; and track progress on quality improvement initiatives.
The health IT community has open and accessible
application programming interfaces (APIs) to encourage entrepreneurial,
user-focused innovation that will make health information more
accessible and improve EHR usability.
ONC will revise the draft TEF based on public comment and
ultimately release a final version of the TEF that will subsequently be
available for adoption by HINs and their participants seeking to
participate in nationwide health information exchange. The goal for
stakeholders that participate in, or serve as, a HIN is to ensure that
participants will have the ability to seamlessly share and receive a
core set of data from other network participants in accordance with a
set of permitted purposes and applicable privacy and security
requirements. Broad adoption of this framework and its associated
exchange standards is intended to both achieve the outcomes described
above while creating an environment more conducive to innovation.
In light of the widespread adoption of EHRs along with the
increasing availability of health information exchange infrastructure
predominantly among hospitals, we are interested in hearing from
stakeholders on how we could use the CMS health and safety standards
that are required for providers and suppliers participating in the
Medicare and Medicaid programs (that is, the Conditions of
Participation (CoPs), Conditions for Coverage (CfCs), and Requirements
for Participation (RfPs) for Long-Term Care (LTC) Facilities) to
further advance electronic exchange of information that supports safe,
effective transitions of care between hospitals and community
providers. Specifically, CMS might consider revisions to the current
CMS CoPs for hospitals, such as: Requiring that hospitals transferring
medically necessary information to another facility upon a patient
transfer or discharge do so electronically; requiring that hospitals
electronically send required discharge information to a community
provider via electronic means if possible and if a community provider
can be identified; and requiring that hospitals make certain
information available to patients or a specified third-party
application (for example, required discharge instructions) via
electronic means if requested.
On November 3, 2015, we published a proposed rule (80 FR 68126) to
implement the provisions of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (the IMPACT Act) (Pub. L. 113-185) and to
revise the discharge planning CoP requirements that hospitals
(including short-term acute care hospitals, long-term care hospitals
(LTCHs), rehabilitation hospitals, psychiatric hospitals, children's
hospitals, and cancer hospitals), critical access hospitals (CAHs), and
home health agencies (HHAs) would need to meet in order to participate
in the Medicare and Medicaid programs. This proposed rule has not been
finalized yet. However, several of the proposed requirements directly
address the issue of communication between providers and between
providers and patients, as well as the issue of interoperability:
Hospitals and CAHs would be required to transfer certain
necessary medical information and a copy of the discharge instructions
and discharge summary to the patient's practitioner, if the
practitioner is known and has been clearly identified;
Hospitals and CAHs would be required to send certain
necessary medical information to the receiving facility/post-acute care
providers, at the time of discharge; and
Hospitals, CAHs, and HHAs would need to comply with the
IMPACT Act requirements that would require hospitals, CAHs, and certain
post-acute care providers to use data on quality measures and data on
resource use measures to assist patients during the discharge planning
process, while taking into account the patient's goals of care and
treatment preferences.
We published another proposed rule (81 FR 39448) on June 16, 2016,
that updated a number of CoP requirements that hospitals and CAHs would
need to meet in order to participate in the Medicare and Medicaid
programs. This proposed rule has not been finalized yet. One of the
proposed hospital CoP revisions in that rule directly addresses the
issues of communication between providers and patients, patient access
to their medical records, and interoperability. We proposed that
patients have the right to access their medical records, upon an oral
or written request, in the form and format requested by such patients,
if it is readily producible in such form and format (including in an
electronic form or format when such medical records are maintained
electronically); or, if not, in a readable hard copy form or such other
form and format as agreed to by the facility and the individual,
including current medical records, within a reasonable timeframe. The
hospital must not frustrate the legitimate efforts of individuals to
gain access to their own medical records and must actively seek to meet
these requests as quickly as its recordkeeping system permits.
We also published a final rule (81 FR 68688) on October 4, 2016,
that revised the requirements that LTC facilities must meet to
participate in the Medicare and Medicaid programs. In this rule, we
made a number of revisions based on the importance of effective
communication between providers during transitions of care, such as
transfers and discharges of residents to other facilities or providers,
or to home. Among these revisions was a requirement that the
transferring LTC facility must provide all necessary information to the
resident's receiving provider, whether it is an acute care hospital, an
LTCH, a psychiatric facility, another LTC facility, a hospice, a home
health agency, or another community-based provider or practitioner (42
CFR 483.15(c)(2)(iii)). We specified that necessary information must
include the following:
Contact information of the practitioner responsible for
the care of the resident;
Resident representative information including contact
information;
Advance directive information;
Special instructions or precautions for ongoing care;
The resident's comprehensive care plan goals; and
All other necessary information, including a copy of the
resident's discharge or transfer summary and any other documentation to
ensure a safe and effective transition of care.
We note that the discharge summary mentioned above must include
reconciliation of the resident's medications, as well as a
recapitulation of the resident's stay, a final summary of the
resident's status, and the post-discharge plan of care. In addition, in
the preamble to the rule, we encouraged LTC facilities to
electronically exchange this information if possible and to identify
opportunities to streamline the collection and exchange of resident
information by using information that the facility is already capturing
electronically.
Additionally, we specifically invite stakeholder feedback on the
following questions regarding possible new or revised CoPs/CfCs/RfPs
for interoperability and electronic exchange of health information:
[[Page 32473]]
If CMS were to propose a new CoP/CfC/RfP standard to
require electronic exchange of medically necessary information, would
this help to reduce information blocking as defined in section 4004 of
the 21st Century Cures Act?
Should CMS propose new CoPs/CfCs/RfPs for hospitals and
other participating providers and suppliers to ensure a patient's or
resident's (or his or her caregiver's or representative's) right and
ability to electronically access his or her health information without
undue burden? Would existing portals or other electronic means
currently in use by many hospitals satisfy such a requirement regarding
patient/resident access as well as interoperability?
Are new or revised CMS CoPs/CfCs/RfPs for interoperability
and electronic exchange of health information necessary to ensure
patients/residents and their treating providers routinely receive
relevant electronic health information from hospitals on a timely basis
or will this be achieved in the next few years through existing
Medicare and Medicaid policies, the implementing regulations related to
the privacy and security standards of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) (Pub. L. 104-91), and
implementation of relevant policies in the 21st Century Cures Act?
What would be a reasonable implementation timeframe for
compliance with new or revised CMS CoPs/CfCs/RfPs for interoperability
and electronic exchange of health information if CMS were to propose
and finalize such requirements? Should these requirements have delayed
implementation dates for specific participating providers and
suppliers, or types of participating providers and suppliers (for
example, participating providers and suppliers that are not eligible
for the Medicare and Medicaid EHR Incentive Programs)?
Do stakeholders believe that new or revised CMS CoPs/CfCs/
RfPs for interoperability and electronic exchange of health information
would help improve routine electronic transfer of health information as
well as overall patient/resident care and safety?
Under new or revised CoPs/CfCs/RfPs, should non-electronic
forms of sharing medically necessary information (for example, printed
copies of patient/resident discharge/transfer summaries shared directly
with the patient/resident or with the receiving provider or supplier,
either directly transferred with the patient/resident or by mail or fax
to the receiving provider or supplier) be permitted to continue if the
receiving provider, supplier, or patient/resident cannot receive the
information electronically?
Are there any other operational or legal considerations
(for example, implementing regulations related to the HIPAA privacy and
security standards), obstacles, or barriers that hospitals and other
providers and suppliers would face in implementing changes to meet new
or revised interoperability and health information exchange
requirements under new or revised CMS CoPs/CfCs/RfPs if they are
proposed and finalized in the future?