80 FR 68126 - Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 212 (November 3, 2015)
Page Range
68126-68155
FR Document
2015-27840
This proposed rule would revise the discharge planning requirements that Hospitals, including Long-Term Care Hospitals and Inpatient Rehabilitation Facilities, Critical Access Hospitals, and Home Health Agencies must meet in order to participate in the Medicare and Medicaid programs. The proposed rule would also implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014.
Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Proposed Rules]
[Pages 68126-68155]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-27840]
[[Page 68125]]
Vol. 80
Tuesday,
No. 212
November 3, 2015
Part IV
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Parts 482, 484, 485
Medicare and Medicaid Programs; Revisions to Requirements for
Discharge Planning for Hospitals, Critical Access Hospitals, and Home
Health Agencies; Proposed Rule
Federal Register / Vol. 80 , No. 212 / Tuesday, November 3, 2015 /
Proposed Rules
[[Page 68126]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 482, 484, and 485
[CMS-3317-P]
RIN 0938-AS59
Medicare and Medicaid Programs; Revisions to Requirements for
Discharge Planning for Hospitals, Critical Access Hospitals, and Home
Health Agencies
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the discharge planning
requirements that Hospitals, including Long-Term Care Hospitals and
Inpatient Rehabilitation Facilities, Critical Access Hospitals, and
Home Health Agencies must meet in order to participate in the Medicare
and Medicaid programs. The proposed rule would also implement the
discharge planning requirements of the Improving Medicare Post-Acute
Care Transformation Act of 2014.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on January 4, 2016.
ADDRESSES: In commenting, please refer to file code CMS-3317-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four 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-3317-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
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-3317-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Alpha-Banu Huq, (410) 786-8687.
Sheila C. Blackstock, (410) 786-1154.
Mary Collins, (410) 786-3189.
Scott Cooper, (410) 786-9465.
Jacqueline Leach, (410) 786-4282.
Lisa Parker, (410) 786-4665.
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 Web
site as soon as possible after they have been received: http://www.regulations.gov . Follow the search instructions on that Web site
to view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Acronyms
Because of the many terms to which we refer by acronym in this
proposed rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
AAA Area Agencies on Aging
ADA Americans with Disabilities Act
ADRC Aging and Disability Resources Centers
AHRQ Agency for Healthcare Research and Quality
AO Accrediting Organization
APRN Advanced Practice Registered Nurse
CAH Critical Access Hospital
CDC Centers for Disease Control and Prevention
CfCs Conditions for Coverage
CIL Centers for Independent Living
CLAS Culturally and Linguistically Appropriate Services in Health
and Health Care
CMS Centers for Medicare and Medicaid Services
COI Collection of Information
CoPs Conditions of Participation
DO Doctor of Osteopathic Medicine
DRG Diagnosis-Related Group
EACH Essential Access Community Hospital
ECQM Electronically Specified Clinical Quality Measures
EHR Electronic Health Records
HHA Home Health Agencies
HHS Department of Health and Human Services
HIE Health Information Exchange
ICR Information Collection Requirements
IT Information Technology
IRF Inpatient Rehabilitation Facility
LTCH Long-Term Care Hospital
MAP Measure Applications Partnership
OASH Office of the Assistant Secretary for Health
OMB Office of Management and Budget
ONC Office of the National Coordinator for Health Information
Technology
PA Physician Assistant
PAC Post-Acute Care
PCP Primary Care Provider
PDMP Prescription Drug Monitoring Program
PRA Paperwork Reduction Act
QAPI Quality Assessment and Performance Improvement
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
RPCH Rural Primary Care Hospital
SA State Survey Agencies
SAMHSA Substance Abuse and Mental Health Services Administration
SNF Skilled Nursing Facility
Table of Contents
I. Background
A. Overview
B. Legislative History
II. Provisions of the Proposed Regulations
A. Hospital Discharge Planning
[[Page 68127]]
1. Design (Proposed Sec. 482.43(a))
2. Applicability (Proposed Sec. 482.43(b))
3. Discharge Planning Process (Proposed Sec. 482.43(c))
4. Discharge to Home (Proposed Sec. 482.43(d))
5. Transfer of Patients to Another Health Care Facility
(Proposed Sec. 482.43(e))
6. Requirements For Post-Acute Care Services (Proposed Sec.
482.43(f))
B. Home Health Agency Discharge Planning
1. Discharge Planning Process (Proposed Sec. 484.58(a))
2. Discharge or Transfer Summary Content (Proposed Sec.
484.58(b))
C. Critical Access Hospital Discharge Planning
1. Design (Proposed Sec. 485.642(a))
2. Applicability (Proposed Sec. 485.642(b))
3. Discharge Planning Process (Proposed Sec. 485.642(c))
4. Discharge to Home (Proposed Sec. 485.642(d)(1) through (3))
5. Transfer of Patients To Another Health Care Facility
(Proposed Sec. 485.642(e))
III. Collection of Information Requirements
A. ICRs Regarding Hospital Discharge Planning (Sec. 482.43)
B. ICRs Regarding Home Health Discharge Planning (Sec. 484.58)
C. ICRs Regarding Critical Access Hospital Discharge Planning
(Sec. 485.642)
IV. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
1. Effects on Hospitals (including LTCHs and IRFs), CAHs, and
HHAs
2. Effects on Small Entities
3. Effects on Patients and Medical Care Costs
D. Alternatives Considered
E. Cost to the Federal Government
F. Accounting Statement
V. Response to Comments
I. Background
A. Overview
Discharge planning is an important component of successful
transitions from acute care hospitals and post-acute care (PAC)
settings. The transition may be to a patient's home (with or without
PAC services), skilled nursing facility, nursing home, long term care
hospital, rehabilitation hospital or unit, assisted living center,
substance abuse treatment program, hospice, or a variety of other
settings. The location to which a patient may be discharged should be
based on the patient's clinical care requirements, available support
network, and patient and caregiver treatment preferences and goals of
care.
Although the current hospital discharge planning process meets the
needs of many inpatients released from the acute care setting, some
discharges result in less-than-optimal outcomes for patients including
complications and adverse events that lead to hospital readmissions.
Reducing avoidable hospital readmissions and patient complications
presents an opportunity for improving the quality and safety of patient
care while lowering health care costs.
Patients' post-discharge needs are frequently complicated and
multi-factorial, requiring a significant level of on-going planning,
coordination, and communication among the health care practitioners and
facilities currently caring for a patient and those who will provide
post-acute care for the patient, including the patient and his or her
caregivers. The discharge planning process should ensure that patients
and, when applicable, their caregivers, are properly prepared to be
active partners and advocates for their healthcare and community
support needs upon discharge from the hospital or PAC setting. Yet
patients and their caregivers frequently are not meaningfully involved
in the discharge planning process and are unable to name their
diagnoses; list their medications, their purpose, or the major side
effects; cannot explain their follow-up plan of care; or articulate
their treatment preferences and goals of care. For patients who require
PAC services, the discharge planning process should ensure that the
transition from one care setting to another (for example, from a
hospital to a skilled nursing facility or to home with help from a home
health agency or community-based services provider (or both) is
seamless. The receiving PAC facilities or organizations should have the
necessary information and be prepared to assume responsibility for the
care of the patient. When patients or receiving facilities or
organizations do not have key information such as the information
previously mentioned, they are less able to implement the appropriate
post-discharge treatment plans. This puts patients at risk for serious
complications and increases their chances of being re-hospitalized.
We also believe that hospitals and critical access hospitals (CAHs)
should improve their focus on psychiatric and behavioral health
patients, including patients with substance use disorders. While the
current discharge planning requirements as well as those proposed in
this rule include this subset of patients, we believe the special
discharge planning needs of these patients are sometimes overlooked. We
encourage hospital and CAHs to take the needs of psychiatric and
behavioral health patients into consideration when planning discharge
and arranging for PAC and community services. With these patients
specifically, and just as we believe it should be with other types of
patients being discharged, we believe hospitals and CAHs must:
Identify the types of services needed upon discharge,
including options for tele-behavioral health services as available and
appropriate;
Identify organizations offering community services in the
psychiatric hospital or unit's community, and demonstrate efforts to
establish partnerships with such organizations; arrange, as applicable,
for the development and implementation of a specific psychiatric
discharge plan for the patient as part of the patient's overall
discharge plan; and
Coordinate with the patient for referral for post-acute
psychiatric or behavioral health care, including transmitting pertinent
information to the receiving organization as well as making
recommendations about the post-acute psychiatric or behavioral health
care needed by the patient.
We have also found that not having a thorough understanding of
available community services can impact the discharge planning process.
If the discharge planning team and patients or their caregivers are not
aware of the full range of post-hospital services available, including
non-medical services and supports, patients may be sent to care
settings that are inappropriate, ineffective, or of inadequate quality.
The lack of consistent collaboration and teamwork among health care
facilities, patients, their families, and relevant community
organizations may negatively impact selection of the best type of
patient placement, leading to less than ideal patient outcomes and
unnecessary re-hospitalizations. When planning transitions, hospitals
should consult with Aging and Disability Resource Centers (ADRCs) (as
defined in section 102 of the Older Americans Act of 1965 (42 U.S.C.
3002)), or Area Agencies on Aging (AAAs) (also defined in section 102
of the Older Americans Act of 1965 (42 U.S.C. 3002)) and Centers for
Independent Living (CILs) (as defined in section 702 of the
Rehabilitation Act of 1973 (29 U.S.C. 796a)), or Substance Abuse Mental
Health Services Administration's (SAMHSA's) treatment locator, or any
combination of the centers or associations. ADRCs, AAAs, and CILs are
required by federal statute to help connect individuals to community
services and supports, and many of these organizations already help
chronically impaired individuals with transitions across settings,
including transitions from hospitals and PAC settings back home.
Ongoing communication with a feedback loop among health care
practitioners and
[[Page 68128]]
relevant community organizations in all patient care settings would
assist in better patient transitions, but this level of communication
has not been consistently achieved among the numerous health care
settings within communities across the country. It is estimated that
one third of re-hospitalizations might be avoided with improved
comprehensive transitional care from hospital to community.\1\
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\1\ (Coleman E, Parry C, Chambers S, Min S: The Care Transitions
Intervention Arch Intern Med. 166 (2006): 1822-1828. and Naylor M,
McCauley K: The effects of a discharge planning and home follow-up
intervention on elders hospitalized with common medical and surgical
cardiac conditions. J Cardiovascular Nurs. 14 (1999): 44-54.).
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We believe the provisions of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) that require
hospitals, including but not limited to acute care hospitals, CAHs and
certain PAC providers including long-term care hospitals (LTCHs),
inpatient rehabilitation facilities (IRFs), home health agencies
(HHAs), and skilled nursing facilities (SNFs), to take into account
quality measures and resource use measures to assist patients and their
families during the discharge planning process will encourage patients
and their families to become active participants in the planning of
their transition to the PAC setting (or between PAC settings). This
requirement will allow patients and their families' access to
information that will help them to make informed decisions about their
post-acute care, while addressing their goals of care and treatment
preferences. Patients and their families that are well informed of
their choices of high-quality PAC providers, including providers of
community services and supports, may reduce their chances of being re-
hospitalized.
B. Legislative History
The IMPACT Act requires the standardization of PAC assessment data
that can be evaluated and compared across PAC provider settings, and
used by hospitals, CAHs, and PAC providers, to facilitate coordinated
care and improved Medicare beneficiary outcomes. Section 2 of the
IMPACT Act added new section 1899B to the Social Security Act (Act).
That section states that the Secretary of the Department of Health and
Human Services (the Secretary) must require PAC providers (that is,
HHAs, SNFs, IRFs and LTCHs) to report standardized patient assessment
data, data on quality measures, and data on resource use and other
measures. Under section 1899B(a)(1)(B) of the Act, patient assessment
data must be standardized and interoperable to allow for the exchange
of data among PAC providers and other Medicare participating providers
or suppliers. Section 1899B(a)(1)(C) of the Act requires the
modification of existing PAC assessment instruments to allow for the
submission of standardized patient assessment data to enable comparison
of this assessment data across providers. The IMPACT Act requires that
assessment instruments be modified to utilize the standardized data
required under section 1899B(b)(1)(A) of the Act, no later than October
1, 2018 for SNFs, IRFs, and LTCHs and no later than January 1, 2019 for
HHAs. The statutory timing varies for the standardized assessment data
described in subsection (b), data on quality measures described in
subsection (c), and data on resource use and other measures described
in subsection (d) of section 1899B. We currently are developing
additional public guidance and we note that many of these PAC
provisions are being addressed in separate rulemakings. More
information can be found on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html.
Section 1899B(j) of the Act requires that we allow for stakeholder
input, such as through town halls, open door forums, and mailbox
submissions, before the initial rulemaking process to implement section
1899B. To meet this requirement, we provided the following
opportunities for stakeholder input: (a) We convened a technical expert
panel (TEP) to gather input on three cross-setting measures identified
as potential measures to the requirements of the IMPACT Act, that
included stakeholder experts and patient representatives on February 3,
2015; (b) we provided two separate listening sessions on February 10th
and March 24, 2015 on the implementation of the IMPACT Act, which also
gave the public the opportunity to give CMS input on their current use
of patient goals, preferences, and health assessment information in
assuring high quality, person-centered and coordinated care enabling
long-term, high quality outcomes; (c) we sought public input during the
February 2015 ad hoc Measure Applications Partnership (MAP) process
regarding the measures under consideration with respect to IMPACT Act
domains; and (d) we implemented a public mail box for the submission of
comments in January 2015 located at [email protected].
The CMS public mailbox can be accessed on our PAC quality initiatives
Web site: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014-and-Cross-Setting-Measures.html. Lastly, we held a National
Stakeholder Special Open Door Forum to seek input on the measures on
February 25, 2015.
Section 1899B(i) of the Act, which addresses discharge planning,
requires the modification of the Conditions of Participation (CoPs) and
subsequent interpretive guidance applicable to PAC providers,
hospitals, and CAHs at least every 5 years, beginning no later than
January 1, 2016. These regulations must require that PAC providers,
hospitals, and CAHs take into account quality, resource use, and other
measures under subsections (c) and (d) of section 1899B in the
discharge planning process.
This proposed rule would implement the discharge planning
requirements mandated in section 1899B(i) of the IMPACT Act by
modifying the discharge planning or discharge summary CoPs for
hospitals, CAHs, IRFs, LTCHs, and HHAs. The IMPACT Act identifies LTCHs
and IRFs as PAC providers, but the hospital CoPs also apply to LTCHs
and IRFs since these facilities, along with short-term acute care
hospital, are classifications of hospitals. All classifications of
hospitals are subject to the same hospital CoPs. Therefore, these PAC
providers (including freestanding LTCHs and IRFs) are also subject to
the proposed revisions to the hospital CoPs. Proposed discharge
planning requirements for SNFs are addressed in the proposed rule,
``Medicare and Medicaid Programs; Reform of Requirements for Long-Term
Care Facilities'' (80 FR 42167, July 16, 2015) at https://www.federalregister.gov/articles/2015/07/16/2015-17207/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities.
Compliance with these requirements will be assessed through on-site
surveys by the Centers for Medicare & Medicaid Services (CMS), State
Survey Agencies (SAs) or Accrediting Organization (AOs) with CMS-
approved Medicare accreditation programs.
II. Provisions of the Proposed Regulations
A. Hospital Discharge Planning
Various sections of the Act list the requirements that each
provider must meet to be eligible for Medicare and Medicaid
participation. Each statutory provision also specifies that the
Secretary may establish other
[[Page 68129]]
requirements as necessary in the interest of the health and safety of
patients. The Medicare CoPs and Conditions for Coverage (CfCs) set
forth the federal health and safety standards that providers and
suppliers must meet to participate in the Medicare and Medicaid
programs. The purposes of these conditions are to protect patient
health and safety and to ensure that quality care is furnished to all
patients in Medicare and Medicaid-participating facilities. In
accordance with section 1864 of the Act, CMS uses state surveyors to
determine whether a provider or supplier subject to certification
qualifies for an agreement to participate in Medicare. However, under
section 1865 of the Act, providers and suppliers subject to
certification may instead elect to be accredited by private accrediting
organizations whose Medicare accreditation programs have been approved
by CMS as having standards and survey procedures that meet or exceed
all applicable Medicare requirements.
Section 1861(e) of the Act defines the term ``hospital'' and
paragraphs (1) through (8) of this section list the requirements that a
hospital must meet to be eligible for Medicare participation. Section
1861(e)(9) of the Act specifies that a hospital must also meet other
requirements as the Secretary finds necessary in the interest of the
health and safety of individuals who are furnished services in the
institution. In addition, section 1861(e)(6)(B) of the Act requires
that a hospital have a discharge planning process that meets the
discharge planning requirements of section 1861(ee) of the Act.
Under section 1861(e) of the Act, the Secretary has established in
regulation at 42 CFR part 482 the requirements that a hospital must
meet to participate in the Medicare program. The hospital CoPs are
found at Sec. 482.1 through Sec. 482.66. Section 1905(a) of the Act
provides that Medicaid payments may be applied to hospital services.
Regulations at Sec. 440.10(a)(3)(iii) require hospitals to meet the
Medicare CoPs to qualify for participation in the Medicaid program.
The current hospital discharge planning requirements at Sec.
482.43, ``Discharge planning,'' were originally published on December
13, 1994 (59 FR 64141), and were last updated on August 11, 2004 (69 FR
49268). Under the current discharge planning requirements, hospitals
must have in effect a discharge planning process that applies to all
inpatients. The hospital must also have policies and procedures
specified in writing. Over the years, we have made continuous efforts
to reduce patient readmissions by strengthening and modernizing the
nation's health care system to provide access to high quality care and
improved health at lower cost. Since 2004, there has been a growing
recognition of the need to make discharge from the hospital to another
care environment safer, and to reduce the rise in preventable and
costly hospital readmissions, which are often due to avoidable adverse
events. As a result of our overall efforts, we refined the discharge
planning regulations in 2004 (69 FR 49268) and updated the interpretive
guidance in 2013 (Pub. L. 100-07, State Operations Manual, Appendix A:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf). We refer readers to the discharge planning
section, ``Condition of Participation for Discharge Planning'', at
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf. As stated in this section of the
State Operations Manual, ``Hospital discharge planning is a process
that involves determining the appropriate post-hospital discharge
destination for a patient; identifying what the patient requires for a
smooth and safe transition from the hospital to his/her discharge
destination; and beginning the process of meeting the patient's
identified post-discharge needs.''
Subsequently, the IMPACT Act was signed on October 6, 2014, and
directs the Secretary to publish regulations to modify CoPs and
interpretive guidance to require PAC providers, hospitals and CAHs take
into account quality, resource use, and other measures required by the
IMPACT Act to assist hospitals, CAHs, PAC providers, patients, and the
families of patients with discharge planning, and to also address the
patient's treatment preferences and goals of care. In light of these
concerns, our continued efforts to reduce avoidable hospital
readmission, and the IMPACT Act requirements, we are proposing to
revise the hospital discharge planning requirements.
The current discharge planning identification process at Sec.
482.43(a) requires hospitals to identify patients for whom a discharge
plan is necessary, but this does not necessarily lead to a discharge
plan. The regulation does not specify criteria for such identification,
leading to variation across acute care hospital settings as to how they
approach this task. Some hospitals use self-developed or industry-
generated criteria for identifying patients who may be in need of a
discharge plan. Others use pre-determined clinical factors such as age,
co-morbidities, previous hospitalizations, and available social support
systems to identify patients who may need a discharge plan.
Additionally, hospitals use any number of other factors such as
physician preference, nursing, social work and case management
experience and history, current workload, and common practice to
develop the discharge plan. Finally, some hospitals develop discharge
plans for every inpatient, regardless of any of the factors previously
mentioned. As a result of these and other differences between
hospitals, there is considerable variation in the extent to which there
are successful transitions from acute care hospitals.
Similarly, the current requirements for a discharge planning
evaluation of a patient, at Sec. 482.43(b), after he or she is
initially identified as potentially needing post-hospital services also
do not guarantee the development of a discharge plan.
Hospital patients discharged back to their home may be given
literature to read about medication usage and required therapies;
prescriptions for post-hospital medications and supplies; and referrals
to post-hospital resources. This approach does not adequately reinforce
the necessary skills that patients, their caregivers, and support
persons need to meet post-hospital clinical needs. Inadequate patient
education has led to poor outcomes, including medication errors and
omissions, infection, injuries, worsening of the initial medical
condition, exacerbation of a different medical condition, and re-
hospitalization.\2\ Lack of patient education concerning medicine
storage, disposal, and use may also be a factor in overdoses, substance
use disorders and diversion of controlled substances.\3\
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\2\ (Calkins D et al.: Patient-Physician Communication at
Hospital Discharge and patient's Understanding of the Postdischarge
Treatment Plan, Arch Intern Med, 157 (1997): 1026-1030. Minott J:
Reducing Hospital Readmissions. Academy of Health. < http://www.academyhealth.org/files/publications/Reducing_Hospital_Readmissions.pdf> Accessed August 23, 2011).
\3\ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077453/pdf/theoncologist_1471.pdf.
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We also note there has been confusion in the hospital setting
regarding the implementation requirement in the current discharge
planning CoP. As stated at current Sec. 482.43(c)(3), the hospital
must arrange for the initial implementation of the patient's discharge
plan. The level of implementation of this standard varies widely,
leading to inconsistent transitions from the acute care hospital. We
believe that providing more specific
[[Page 68130]]
requirements to hospitals on what actions they must take prior to the
patient's discharge or transfer to a PAC setting would lead to improved
transitions of care and patient outcomes.
We propose to revise the existing requirements in the form of six
standards at Sec. 482.43. The most notable revision would be to
require that all inpatients and specific categories of outpatients be
evaluated for their discharge needs and have a written discharge plan
developed. Many of the current discharge planning concepts and
requirements would be retained, but revised to provide more clarity. We
also propose to require specific discharge instructions for all
patients. At present, hospitals have some discretion and not every
patient receives specific, written instructions.
We have reviewed the available literature on readmissions and
sought to understand the various factors that influence the causes of
avoidable readmissions. We recognize that much evidence-based research
has been done to identify interventions that reduce readmissions of
individuals with specific characteristics or conditions such as the
elderly, cardiac patients, and patients with chronic conditions.
We propose to continue our efforts to reduce patient readmissions
by improving the discharge planning process that would require
hospitals to take into account the patient's goals and preferences in
the development of their plans and to better prepare patients and their
caregiver/support person(s) (or both) to be active participants in
self-care and by implementing requirements that would improve patient
transitions from one care environment to another, while maintaining
continuity in the patient's plan of care. The following is a discussion
of each of the proposed standards.
We propose at Sec. 482.43, Discharge planning, to require that a
hospital have a discharge planning process that focuses on the
patient's goals and preferences and on preparing patients and, as
appropriate, their caregivers/support person(s) to be active partners
in their post-discharge care, ensuring effective patient transitions
from hospital to post-acute care while planning for post-discharge care
that is consistent with the patient's goals of care and treatment
preferences, and reducing the likelihood of hospital readmissions.
1. Design (Proposed Sec. 482.43(a))
In newly proposed Sec. 482.43(a), we propose to establish a new
standard, ``Design'', and would require that hospital medical staff,
nursing leadership, and other pertinent services provide input in the
development of the discharge planning process. We also propose to
require that the discharge planning process be specified in writing and
be reviewed and approved by the hospital's governing body. We would
expect that the discharge planning process policies and procedures
would be developed and reviewed periodically by the hospital's
governing body.
2. Applicability (Proposed Sec. 482.43(b))
We propose to revise the current requirement at Sec. 482.43(a),
which requires a hospital to identify those patients for whom a
discharge plan is necessary. At proposed Sec. 482.43(b),
``Applicability,'' we would require that many types of patients be
evaluated for post discharge needs. We would require that the discharge
planning process apply to all inpatients, as well as certain categories
of outpatients, including, but not limited to patients receiving
observation services, patients who are undergoing surgery or other
same-day procedures where anesthesia or moderate sedation is used,
emergency department patients who have been identified by a
practitioner as needing a discharge plan, and any other category of
outpatient as recommended by the medical staff, approved by the
governing body and specified in the hospital's discharge planning
policies and procedures. We believe that the aforementioned categories
of patients would benefit from an evaluation of their discharge needs
and the development of a written discharge plan.
3. Discharge Planning Process (Proposed Sec. 482.43(c))
We propose at Sec. 482.43(c), ``Discharge planning process,'' to
require that hospitals implement a discharge planning process to begin
identifying, early in the hospital stay, the anticipated post-discharge
goals, preferences, and needs of the patient and begin to develop an
appropriate discharge plan for the patients identified in proposed
Sec. 482.43(b). The average length of stay in the hospital setting has
decreased significantly since the current discharge planning standards
were written. Timely identification of the patient's goals,
preferences, and needs and development of the discharge plan would
reduce delays in the overall discharge process. We propose to require
that the discharge plan be tailored to the unique goals, preferences
and needs of the patient. For example, based on the anticipated
discharge needs, a discharge plan in the early stages of development
for a young healthy patient could possibly be as concise as a plan to
provide instructions on follow-up appointments, and information on the
warning signs and symptoms which may indicate the need to seek medical
attention. On the other hand, the discharge needs of patients with co-
morbidities, complex medical or surgical histories (or both), with
mental health or substance use disorders (including indications of
opioid abuse), socio-economic and literacy barriers, and multiple
medications would require a more extensive discharge plan that takes
into account all of these factors and the patients treatment
preferences and goals of care. As previously discussed, patient
referrals to or consultation with community care organizations will be
a key step, for some, in assuring successful patient outcomes.
Therefore, we believe that discharge planning for patients is a process
that involves the consideration of the patient's unique circumstances,
treatment preferences, and goals of care, and not solely a
documentation process.
We remind hospitals that they must continue to abide by federal
civil rights laws, including Title VI of the Civil Rights Act of 1964,
the Americans with Disabilities Act (ADA), and section 504 of the
Rehabilitation Act of 1973, when developing a discharge planning
process. To this end, hospitals should take reasonable steps to provide
individuals with limited English proficiency or physical, mental, or
cognitive and intellectual disabilities meaningful access to the
discharge planning process, as required under Title VI of the Civil
Rights Act, as implemented at 45 CFR 80.3(b)(2). Discharge planning
would be of little value to patients who cannot understand or
appropriately follow the discharge plans discussed in this rule.
Without appropriate language assistance or auxiliary aids and services,
discharge planners would not be able to fully involve the patient and
caregiver/support person in the development of the discharge plan.
Furthermore, the discharge planner would not be fully aware of the
patient's goals for discharge.
Additionally, effective discharge planning will assist hospitals in
complying with the U.S. Supreme Court's holding in Olmstead v. L.C.
(527 U.S. 581 (1999)), which found that the unjustified segregation of
people with disabilities is a form of unlawful discrimination under the
ADA. We note that effective discharge planning may assist hospitals in
ensuring that individuals being discharged who
[[Page 68131]]
would otherwise be entitled to institutional services, have access to
community based services when: (a) Such placement is appropriate; (b)
the affected person does not oppose such treatment; and (c) the
placement can be reasonably accommodated.
We also remind hospitals, HHAs, and CAHs of existing state laws and
requirements regarding discharge planning and their obligations to
abide by these requirements. Additionally, they should also be aware of
unique and innovative state programs focused on discharge planning.
We propose to combine and revise two existing requirements, Sec.
482.43(b)(2) and Sec. 482.43(c)(1), into a single requirement at Sec.
482.43(c)(1), simplifying the requirement and incorporating some minor
clarifying revisions. The resulting provision would require that a
registered nurse, social worker, or other personnel qualified in
accordance with the hospital's discharge planning policy, coordinate
the discharge needs evaluation and the development of the discharge
plan.
In proposed Sec. 482.43(c)(2), we propose to establish a specific
time frame during which discharge planning must begin. Section
482.43(a) currently requires a hospital to identify those patients who
may need a discharge plan at an early stage of hospitalization.
Ideally, discharge planning begins at the time of inpatient admission
or outpatient registration. We understand that this is not always
practicable. However, the current requirement might be considered too
imprecise and could allow for discharge planning to be repeatedly
delayed and perhaps several days to elapse before discharge planning is
considered. Therefore, we would clarify the requirement by requiring
that a hospital would begin to identify anticipated discharge needs for
each applicable patient within 24 hours after admission or
registration, and the discharge planning process is completed prior to
discharge home or transfer to another facility and without unduly
delaying the patient's discharge or transfer. If the patient's stay was
less than 24 hours, the discharge needs would be identified prior to
the patient's discharge home or transfer to another facility. This
policy would not apply to emergency-level transfers for patients who
require a higher level of care. However, while an emergency-level
transfer would not need a discharge evaluation and plan, we would
expect that the hospital would send necessary and pertinent information
with the patient that is being transferred to another facility.
We propose to retain the current requirement set out at Sec.
482.43(c)(4), and re-designate it with clarifications at Sec.
482.43(c)(3). Currently we require that the hospital reassess the
patient's discharge plan if there are factors that may affect
continuing care needs or the appropriateness of the discharge plan. We
propose at Sec. 482.43(c)(3) to require that the hospital's discharge
planning process ensure an ongoing patient evaluation throughout the
patient's hospital stay or visit to identify any changes in the
patient's condition that would require modifications to the discharge
plan. The evaluation to determine a patient's continued hospitalization
(or in other words, their readiness for discharge or transfer), is a
current standard medical practice, and additionally is a current
hospital CoP requirement at Sec. 482.24(c). This proposed standard
would expand upon the current regulation by requiring that the
discharge evaluation be ongoing, during the patient's hospitalization
or outpatient visit, and that any changes in a patient's condition that
would affect the patient's readiness for discharge or transfer be
reflected and documented in the discharge plan.
We propose a new requirement at Sec. 482.43(c)(4) that the
practitioner responsible for the care of the patient be involved in the
ongoing process of establishing the patient's goals of care and
treatment preferences that inform the discharge plan, just as they are
with other aspects of patient care during the hospitalization or
outpatient visit.
We propose to re-designate Sec. 482.43(b)(4) as Sec. 482.43(c)(5)
to require, that as part of identifying the patient's discharge needs,
the hospital consider the availability of caregivers and community-
based care for each patient, whether through self-care, follow-up care
from a community-based providers, care from a caregiver/support
person(s), care from post-acute health care facilities or, in the case
of a patient admitted from a long-term care or other residential care
facility, care in that setting.
Hospitals should be consistent in how they identify and evaluate
the anticipated post-discharge needs of the patient to support and
facilitate a safe transition from one care environment to another. The
proposed requirement at Sec. 482.43(c)(5) would require hospitals to
consider the patient's or caregiver's capability and availability to
provide the necessary post-hospital care. As part of the on-going
discharge planning process, hospitals would identify areas where the
patient or caregiver/support person(s) would need assistance, and
address those needs in the discharge plan in a way that takes into
account the patient's goals and preferences. In addition, we encourage
hospitals to consider potential technological tools or methods, such as
telehealth, to support the individual's health upon discharge
We propose that hospitals consider the availability of and access
to non-health care services for patients, which may include home and
physical environment modifications including assistive technologies,
transportation services, meal services or household services (or both),
including housing for homeless patients. These services may not be
traditional health care services, but they may be essential to the
patient's ongoing care post-discharge and ability to live in the
community. Hospitals should be able to provide additional information
on non-health care resources and social services to patients and their
caregiver/support person(s) and they should be knowledgeable about the
availability of these resources in their community, when applicable. In
addition, we encourage hospitals to consider the availability of
supportive housing, as an alternative to homeless shelters that can
facilitate continuity of care for patients in need of housing.
We would expect hospitals to be well informed of the availability
of community-based services and organizations that provide care for
patients who are returning home or who want to avoid
institutionalization, including ADRCs, AAAs, and CILs, and provide
information on these services and organizations when appropriate.
ADRCs, AAAs, and CILs are required by federal statute to help connect
individuals to community services and supports, and many of these
organizations already help chronically impaired individuals with
transitions across settings, including transitions from hospitals and
PAC settings back home.
We encourage hospitals to develop collaborative partnerships with
providers of community-based services to improve transitions of care
that might support better patient outcomes. More information on these
community-based services and organizations can be found in the
following Web sites:
For Information on Aging and Disability Resource
Centers (ADRCs): http://www.adrc-tae.acl.gov/tiki-index.php?page=HomePage For information on Centers for Independent Living (CILs):
http://www.ilru.org/projects/cil-net/cil-center-and-association-directory For information on Area Agencies on Aging (AAAs): http://
www.aoa.acl.gov/AoA_Programs/OAA/
[[Page 68132]]
How_To_Find/Agencies/find_agencies.aspx
Accordingly, we propose that hospitals must consider the following
in evaluating a patient's discharge needs, including but not limited
to:
Admitting diagnosis or reason for registration;
Relevant co-morbidities and past medical and surgical
history;
Anticipated ongoing care needs post-discharge;
Readmission risk;
Relevant psychosocial history;
Communication needs, including language barriers,
diminished eyesight and hearing, and self-reported literacy of the
patient, patient's representative or caregiver/support person(s), as
applicable;
Patient's access to non-health care services and
community-based care providers; and
Patient's goals and treatment preferences.
During the evaluation of a patient's relevant co-morbidities and
past medical and surgical history, we encourage providers to consider
using their state's Prescription Drug Monitoring Program (PDMP). PDMPs
are state-run electronic databases used to track the prescribing and
dispensing of controlled prescription drugs to patients. They are
designed to monitor this information for suspected abuse or diversion
and can give a prescriber or pharmacist critical information regarding
a patient's controlled substance abuse history. This information can
help prescribers and pharmacists identify high-risk patients who would
benefit from early interventions (http://www.cdc.gov/drugoverdose/pdmp/
).
In 2013, HHS prepared a report to Congress regarding enhancing the
interoperability of State prescription drug monitoring programs with
other technologies and databases used for detecting and reducing fraud,
diversion, and abuse of prescription drugs. The report, prepared by The
Office of the Assistant Secretary for Health (OASH), The Office of the
National Coordinator for Health Information Technology (ONC), SAMHSA,
and the Centers for Disease Control and Prevention (CDC) cites positive
research that suggests that PDMPs reduce the prescribing of Schedule II
opioid analgesics, lowers substance abuse treatment rates from opioids,
and potentially reduces doctor shopping by increasing awareness among
providers about at-risk patients. In addition, the report notes that
surveys indicate that prescribers find PDMPs to be useful tools.
In addition to highlighting the potential benefits, the report
finds that PDMPs encounter challenges in two areas: Legal and policy
challenges and technical challenges. Specifically, the report points
out issues, including significant interoperability problems, such as
the lack of standard methods to exchange and integrate data from PDMPs
to health IT systems. The report also describes legal and policy issues
regarding who can use and access PDMPs, concerns with timely data
transmission, concerns about the reliance on third parties to transmit
data between states, and privacy and security challenges. In addition,
the report discusses fiscal challenges, technical challenges including
the lack of common technical standards, vocabularies, system-level
access controls to share information with EHRs and pharmacy systems,
data transmission concerns, and concerns with the current manner in
which providers access the electronic PDMP database.
The report concludes that while PDMPs are promising tools to reduce
the prescription drug abuse epidemic and improve patient care,
addressing these existing challenges can greatly improve the ability of
states to establish interoperability and leverage PDMPs to reduce
fraud, diversion, and abuse of prescription drugs. The report offers
several recommendations for addressing these challenges and we refer
readers to the report in its entirety at the following Web site:
https://www.healthit.gov/sites/default/files/fdasia1141report_final.pdf.
Given the potential benefits of PDMPs as well as some of the
challenges noted above, we are soliciting comments on whether providers
should be required to consult with their state's PDMP and review a
patient's risk of non-medical use of controlled substances and
substance use disorders as indicated by the PDMP report. As discussed
in detail below we are also soliciting comments on the use of PDMPs in
the medication reconciliation process.
We propose a new requirement at Sec. 482.43(c)(6) that the patient
and the caregiver/support person(s), be involved in the development of
the discharge plan and informed of the final plan to prepare them for
post-hospital care. Hospitals should integrate input from the patient,
caregiver/support person(s) whenever possible. This proposed
requirement provides the opportunity to engage the patient or
caregiver/support person(s) (or both) in post-discharge-decision making
and supports the current patient rights requirement at Sec. 483.13 in
which the patient has the right to participate in and make decisions
regarding the development and implementation of his or her plan of
care. This proposed requirement clarifies our current expectation
regarding engaging caregivers/support persons in evaluating and
planning a patient's discharge or transfer.
We propose a new requirement at Sec. 482.43(c)(7) to require that
the patient's discharge plan address the patient's goals of care and
treatment preferences. During the discharge planning process, we would
expect that the appropriate medical staff would discuss the patient's
post-acute care goals and treatment preferences with the patient, the
patient's family or their caregiver/support persons (or both) and
subsequently document these goals and preferences in the medical
record. We would expect these documented goals and treatment
preferences to be taken into account throughout the entire discharge
planning process.
We propose a new requirement at Sec. 482.43(c)(8) to require that
hospitals assist patients, their families, or their caregiver's/support
persons in selecting a PAC provider by using and sharing data that
includes but is not limited to HHA, SNF, IRF, or LTCH data on quality
measures and data on resource use measures. Furthermore, the hospital
would have to ensure that the PAC data on quality measures and data on
resource use measures is relevant and applicable to the patient's goals
of care and treatment preferences. We would also expect the hospital to
document in the medical record that the PAC data on quality measures
and resource use measures were shared with the patient and used to
assist the patient during the discharge planning process.
We note that quality measures are defined in the IMPACT Act as
measures relating to at least the following domains: Standardized
patient assessments, including functional status, cognitive function,
skin integrity, and medication reconciliation; by contrast, resource
use measures are defined as including total estimated Medicare spending
per individual, discharge to community, and measures to reflect all-
condition risk-adjusted preventable hospital readmission rates.
Accordingly, this proposed rule does not address or include further
definition of these terms, which will be addressed and established in
forthcoming regulations or other issuances. However, we advise
providers to use other sources for information on PAC quality and
resource use data, such as the data provided through the Nursing Home
Compare and Home Health Compare Web sites, until the measures
stipulated
[[Page 68133]]
in the IMPACT Act are finalized. Once these measures are finalized,
providers will be required to use the measures as directed by the
appropriate regulations and issuances.
As required by the IMPACT Act, hospitals must take into account
data on quality measures and data on resource use measures of PAC
providers during the discharge planning process. We would expect that
the hospital would be available to discuss and answer patients and
their caregiver's questions about their post-discharge options and
needs.
In order to increase patient involvement in the discharge planning
process and to emphasize patient preferences throughout the patient's
course of treatment, we believe that hospitals must consider the
aforementioned data in light of the patient's goals of care and
treatment preferences. For example, the hospital could provide quality
data on PAC providers that are within the patient's preferred
geographic area. In another instance, hospitals could provide quality
data on HHAs based on the patient's need for continuing care post-
discharge and preference to receive this care at home. Hospitals should
assist patients as they choose a high quality PAC provider. However, we
would expect that hospitals would not make decisions on PAC services on
behalf of patients and their families and caregivers and instead focus
on person-centered care to increase patient participation in post-
discharge care decision making. Person-centered care focuses on the
patient as the locus of control, supported in making their own choices
and having control over their daily lives.
We propose to re-designate and revise the current requirement set
out at Sec. 482.43(b)(5) at new Sec. 482.43(c)(9). We would require
that the patient's discharge needs evaluation and discharge plan be
documented and completed on a timely basis, based on the patient's
goals, preferences, strengths, and needs, so that appropriate
arrangements for post-hospital care are made before discharge. This
requirement would prevent the patient's discharge or transfer from
being unduly delayed. We believe that in response to this requirement,
hospitals would establish more specific time frames for completing the
evaluation and discharge plans based on the needs of their patients and
their own operations. All relevant patient information would be
incorporated into the discharge plan to facilitate its implementation
and the discharge plan must be included in the patient's medical
record. The results of the evaluation must also be discussed with the
patient or patient's representative. Furthermore, we believe that
hospitals will use their evaluation of the discharge planning process,
with solicitation of feedback from other providers and suppliers in the
community, as well as from patients and caregivers, to revise their
timeframes, as needed. We encourage hospitals to make use of available
health information technology, such as health information exchanges, to
enhance the efficiency and effectiveness of their discharge process.
We propose to re-designate and revise the requirement at current
Sec. 482.43(e) at new Sec. 482.43(c)(10). We would require that the
hospital assess its discharge planning process on a regular basis. We
propose to require that the assessment include ongoing review of a
representative sample of discharge plans, including patients who were
readmitted within 30 days of a previous admission, to ensure that they
are responsive to patient discharge needs. This evaluation will assist
hospitals to improve the discharge planning process. We believe the
evaluation can be incorporated into the Quality Assessment and
Performance Improvement (QAPI) process, although we have not explicitly
required this coordination and solicit comments on doing so.
4. Discharge to Home (Proposed Sec. 482.43(d))
We propose to re-designate and revise the current requirement at
Sec. 482.43(c)(5) (which currently requires that as needed, the
patient and family or interested persons be counseled to prepare them
for post-hospital care) as Sec. 482.43(d), ``Discharge to home,'' to
require that the discharge plan include, but not be limited to,
discharge instructions for patients described in proposed Sec.
482.43(b) in order to better prepare them for managing their health
post-discharge. The phrase ``patients discharged to home'' would
include, but not be limited to, those patients returning to their
residence, or to the community if they do not have a residence, who
require follow-up with their primary care provider (PCP) or a
specialist; HHAs; hospice services; or any other type of outpatient
health care service. The phrase ``patients discharged to home'' would
not refer to patients who are transferred to another inpatient acute
care hospital, inpatient hospice facility or a SNF. We believe that our
proposed revisions to the current requirement provide more clarity with
respect to our proposed intent, and allow us to state more fully what
we would expect in the way of better preparing the patient or their
caregiver(s)/support persons (or both) regarding post-discharge care.
We propose at Sec. 482.43(d)(1) that discharge instructions must
be provided at the time of discharge to patients, or the patient's
caregiver/support person (s), (or both) who are discharged home or who
are referred to PAC services. We are also proposing that practitioners/
facilities (such as a HHA or hospice agency and the patient's PCP),
receive the patient's discharge instructions at the time of discharge
if the patient is referred to follow up PAC services. Discharge
instructions can be provided to patients and their caregivers/support
person(s) in different ways, including in paper and electronic formats,
depending on the needs, preferences, and capabilities of the patients
and caregivers. We would expect that discharge instructions would be
carefully designed to be easily understood by the patient or the
patient's caregiver/support person (or both). Resources on providing
information that can be easily understood by patients are readily
available and we refer readers to the National Standards for Culturally
and Linguistically Appropriate Services in Health and Health Care (the
National CLAS Standards), for guidance on providing instructions in a
culturally and linguistically appropriate manner at https://www.thinkculturalhealth.hhs.gov/content/clas.asp. The National CLAS
Standards are intended to advance health equity, improve quality, and
help eliminate health care disparities by providing a blueprint for
individuals and health and health care organizations to implement
culturally and linguistically appropriate services.
In addition, as a best practice, hospitals should confirm patient
or the patient's caregiver/support person's (or both) understanding of
the discharge instructions. We recommend that hospitals consider the
use of ``teach-back'' during discharge planning and upon providing
discharge instructions to the patient. ``Teach-back'' is a way to
confirm that a practitioner has explained to the patient what he or she
needs to know in a manner that the patient understands. Training on the
use of ``teach-back'' to ensure patient understanding of transition of
care planning and appropriate medication use is readily available and
we refer readers to the following resource for information on the use
of ``teach-back'': http://www.teachbacktraining.org. At Sec.
482.43(d)(2), we propose to set forth the minimum requirements for
discharge instructions. The purpose of
[[Page 68134]]
discharge instructions is to guide patients and caregivers in the
appropriate provision of post-discharge care. We propose to clarify our
current requirement in Sec. 482.43(c)(5) to require hospitals to
provide instruction to the patient and his or her caregivers about care
duties that they will need to perform in the patient's home.
Instruction would be based on the specific needs of the patient as
determined in the patient's discharge plan. This proposed requirement
is consistent with the current requirement set forth at Sec.
482.43(c)(5), which requires that ``the patient and family members or
interested persons must be counseled to prepare them for post-hospital
care . . . .'' We propose a new requirement at Sec. 482.43(d)(2)(ii)
that the discharge instructions include written information on the
warning signs and symptoms that patients and caregivers should be aware
of with respect to the patient's condition. The warning signs and
symptoms might indicate a need to seek medical attention from an
appropriate provider, depending on the severity level of the signs or
symptoms. The written information would include instructions on what
the person should do if these warning signs and symptoms present.
Furthermore, the discharge instructions would include information about
who to contact if these warning signs and symptoms present. This
contact information may include practitioners such as the patient's
primary care practitioner, the practitioner who was responsible for the
patient's care while in the hospital or hospital emergency care
departments, specialists, home health services, hospice services, or
any other type of outpatient health care service.
At Sec. 482.43(d)(2)(iii), we propose to require that the
patient's discharge instructions include all medications prescribed and
over-the-counter for use after the patient's discharge from the
hospital. This should include a list of the name, indication, and
dosage of each medication along with any significant risks and side
effects of each drug as appropriate to the patient. Furthermore, we
propose a new requirement at Sec. 482.43(d)(2)(v) that the patient's
medications would be reconciled. Medication reconciliation, according
to the American Medical Association, is the process of making sense of
patient medications and resolving conflicts between different sources
of information to minimize harm and maximize therapeutic effects.\4\
Patients, especially those with co-morbidities or chronic illnesses,
often have multiple health care providers who prescribe medication. We
note that interactions between specific prescription medications, as
well as between specific prescription medications and over-the-counter
medications, herbal preparations, and supplements are a growing
concern, and are often not documented in the medical record. Medication
reconciliation aims to improve patient safety by enhancing medication
management.
---------------------------------------------------------------------------
\4\ American Medical Association, ``The Physician's Role in
Medication Reconciliation,'' 2007.
---------------------------------------------------------------------------
In the context of this proposed rule, medication reconciliation
would include reconciliation of the patient's discharge medication(s)
as well as with the patient's pre-hospitalization/visit medication(s)
(both prescribed and over-the-counter); comparing the medications that
were prescribed before the hospital stay/visit and any medications
started during the hospital stay/visit that are to be continued after
discharge, and any new medications that patients would need to take
after discharge. We would expect that any medication discrepancies
(omissions, duplications, conflicts) would be corrected as part of the
medication reconciliation process. Hospitals may utilize a number of
approaches to ensure vigilant medication reconciliation. The medication
reconciliation process should be a partnership between the patient and
the healthcare team, be person-centered, and incorporate solutions to
linguistic, cultural, socio-economic, and literacy barriers. We are
proposing that all patients have an accurate medication list prior to
hospital discharge or transfer. The actual process used for medication
reconciliation might vary among hospitals. We encourage hospitals to
make use of current health information technology when establishing
their medication reconciliation process. There are also many published
resources available to assist hospitals with implementing this
requirement. We refer readers to the following examples of resources
that can be used to assist hospitals with the implementation of a
medication reconciliation process:
The Re-Engineered Discharge (RED) Toolkit (http://www.ahrq.gov/professionals/systems/hospital/red/toolkit/index.html)
includes guidance on educating patients on diagnoses, self-care, and
warning signs, overcoming language barriers, and conducting post-
discharge telephone calls.
The Hospital Guide to Reducing Medicaid Readmissions
(http://www.ahrq.gov/professionals/systems/hospital/medicaidreadmitguide/index.html) describes actions to improve
transitions of care for vulnerable patients, including providing
enhanced services for high risk patients.
The AHRQ Health Literacy Universal Precautions Toolkit
(http://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/) contains tools on clear
communication, the teach-back method, helping patients take medicine
correctly, and encouraging questions.
The SHARE Approach (http://www.ahrq.gov/professionals/education/curriculum-tools/shareddecisionmaking/) is a 5-step process
for shared decision making that includes assessing patients' values and
preferences.
The Guide to Patient and Family Engagement in Hospital
Quality and Safety (http://www.ahrq.gov/professionals/systems/hospital/engagingfamilies/) provides strategies to engage patients and families
in discharge planning throughout their stay.
Medications at Transitions and Clinical Handoffs (MATCH)
Toolkit for Medication Reconciliation (http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/match/match.pdf) helps facilities establish a sound
medication reconciliation process, evaluate the effectiveness of the
existing processes, and identify and respond to any gaps.
The MARQUIS (Multi-Center Medication Reconciliation
Quality Improvement Study) (https://innovations.ahrq.gov/qualitytools/multi-center-medication-reconciliation-quality-improvement-study-marquis-toolkit) Toolkit helps facilities develop better ways for
medications to be prescribed, documented, and reconciled accurately and
safely at times of care transitions when patients enter and leave the
hospital.
To enhance patient understanding of their medications, generic and
proprietary names are expected to be provided for each medication, when
available. The patient or caregiver/support person (or both) may be
involved in reconciling medications and creating a new medication list.
We would also expect that the medication reconciliation process would
include a written list of all medications that a patient should take
until further instructions are given by his or her practitioner at a
follow-up appointment.
Furthermore, we would expect the medication reconciliation process
to consider how patients would obtain their post-discharge medications.
Many of the types of patients for whom discharge planning would be
required under the proposed regulation are discharged from the hospital
with
[[Page 68135]]
medication prescriptions. Many patients do not realize that they will
need to have prescriptions filled to continue the medication therapy
that was started during their hospitalization/visit. A delay in
obtaining necessary medication post-discharge could have significant
adverse health effects. We believe patients or caregivers (or both)
should be informed, in advance of the hospital discharge, of the
anticipated need for filling outpatient (discharge) prescriptions, and
have a plan on how they will obtain those medications. When necessary,
assistance should be offered to the patient with identifying a pharmacy
to fill the prescriptions post-discharge in a timely manner. In
identifying a pharmacy, the hospital should consider whether the
patient has prescription drug coverage that might require the patient
to use a pharmacy within the drug plan's network and direct the patient
appropriately.
As part of the medication reconciliation process, we encourage
practitioners to consult with their state's PDMP. In section II.A.3 of
this proposed rule we discuss the potential benefits as well as the
challenges associated with the use of PDMPs. Given these potential
benefits and challenges, we are soliciting comments on whether, as part
of the medication reconciliation process, practitioners should be
required to consult with their state's PDMP to reconcile patient use of
controlled substances as documented by the PDMP, even if the
practitioner is not going to prescribe a controlled substance.
We propose a new requirement at Sec. 482.43(d)(2)(v) that written
instructions, in paper or electronic format (or both), would be
provided to the patient, and that the instructions would document
follow-up care, appointments, pending and/or planned diagnostic tests,
and any pertinent telephone numbers for practitioners that might be
involved in the patient's follow-up care or for any providers/suppliers
to whom the patient has been referred for follow-up care. The choice of
format of the instructions should be based on patient and caregiver
needs, preferences, and capabilities. Clear communication and
discussions with the patient or other caregivers (or both) for follow-
up care are an important determinant of patient outcomes following
hospitalization. Hospitals should ascertain that the patient
understands their discharge instructions. The major elements of any
follow-up care would be required to be written so that the patient,
caregiver/support person can refer to them post-hospitalization.
In addition to the patient receiving discharge instructions, it is
important that the providers responsible for follow-up care with a
patient (including the primary care provider (PCP) or other
practitioner) receive the necessary medical information to support
continuity of care. We therefore propose at Sec. 482.43(d)(3) to
require that the hospital send the following information to the
practitioner (s) responsible for follow up care, if the practitioner
has been clearly identified:
A copy of the discharge instructions and the discharge
summary within 48 hours of the patient's discharge;
Pending test results within 24 hours of their
availability;
All other necessary information as specified in proposed
Sec. 482.43(e)(2).
We remind hospitals to provide this information in a manner that
complies with all applicable privacy and security regulations.
Finally, we propose a new Sec. 482.43(d)(4) to require, for
patients discharged to home, that the hospital must establish a post-
discharge follow-up process. Many studies have found that many patients
experience major adverse health events post-discharge. These are often
associated with medication compliance. As one example, a study, funded
by Agency for Healthcare Research and Quality (AHRQ) and published in
the Annals of Internal Medicine, found that one in five patients has a
complication or adverse event after being discharged from the
hospital.\5\ Another study using data from all Florida hospitals found
that 7.86 percent of hospital admissions were potentially preventable,
related to the original condition requiring admission, and occurred
within the first several weeks after discharge.\6\ Post-discharge
telephone call programs can improve patient safety and patient
satisfaction, and may decrease the likelihood of post-discharge adverse
events and hospital readmission. Post-discharge follow-up can help
ensure that patients comprehend and adhere to their discharge
instructions and medication regimens. Furthermore, post-discharge
follow-up may identify problems in initiating follow-up care and detect
complications of recovery early, resulting in early intervention,
improved outcomes, and reduced re-hospitalization. A recent meta-
analysis found a number of studies dealing with post-discharge follow-
up.\7\ This study ``found that a home visit within three days, care
coordination by a nurse (most frequently a registered nurse or
advanced-practice nurse), and communication between the hospital and
the primary care provider were components of transitional care that
were significantly associated with reduced short-term readmission
rates.'' We do not propose to specify the mechanism(s) or timing of the
follow-up program so that hospitals can determine how to best meet the
needs of their patient population. However, we note the importance of
ensuring that hospitals follow-up, post-discharge, with their most
vulnerable patients, including those with behavioral health conditions.
We encourage hospitals to consider the use of innovative, low-cost
post-discharge tools and technologies where health care providers and
caregivers can ask simple questions that help identify at-risk
individuals, that can be utilized for identifying those at risk for
readmissions.
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\5\ Adverse Drug Events Occurring Following Hospital Discharge.
Forster, et al., 2005.
\6\ Norbert Goldfield et al., ``Identifying Potentially
Preventable Readmissions,'' Health Care Financing Review, Fall 2008.
\7\ Kim J. Verhaegh et al, ``Transitional Care Interventions
Prevent Hospital Readmissions for Adults with Chronic Illnesses,''
Health Affairs, 33, no. 9 (2014).
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5. Transfer of Patients to Another Health Care Facility (Proposed Sec.
482.43(e))
We propose to re-designate and revise the standard currently set
out at Sec. 482.43(d) as Sec. 482.43(e), ``Transfer of patients to
another health care facility,'' by clarifying our expectations of the
discharge and transfer of patients. We would continue to require that
all hospitals communicate necessary information of patients who are
discharged with transfer to another facility. The receiving facility
may be another hospital (including an inpatient psychiatric hospital or
a CAH) or a PAC facility. We believe that the transition of the patient
from one environment to another should occur in a way that promotes
efficiency and patient safety, through the communication of necessary
information between the hospital and the receiving facility. We believe
that the timely communication of necessary clinical information between
health care providers support continuity of patient care, improves
patient safety, and can reduce hospital readmissions. In 2014, many
hospitals were using certified electronic health records that capture
and standardize clinical data necessary to ensure safe transition in
care delivery.
The current discharge requirement set out at Sec. 482.43(d)
requires hospitals that transfer patients to another facility to send
with the patient (at the time of
[[Page 68136]]
transfer) the necessary medical information to the receiving facility.
We know that transfers represent an increased period of risk for
patients and that effective communication between care providers during
transfers reduce this risk. In recognition of this, in August of 2011,
the State of New Jersey mandated the use of a universal transfer form.
Rhode Island and Massachusetts have also developed a continuity of care
document or universal transfer form. The American Medical Directors
Association has developed and recommends the use of a universal
transfer form. Additionally, other tools and information are available
from CMS (see http://innovation.cms.gov/initiatives/CCTP/index.html)
and AHRQ (see http://www.innovations.ahrq.gov/content.aspx?id=2577) as
well as through a number of professional organizations, including the
National Transitions of Care Coalition (www.ntocc.org). Electronic
health records could simplify the process of extracting necessary
information when a resident is transferred to a nursing home and
electronic Continuity of Care documents provide a standardized way to
exchange critical information between providers. All of these tools and
efforts are targeted at improving the communications between healthcare
providers at the time of transfer. We do not propose to mandate a
specific transfer form. However, we do propose to clarify our
expectations regarding what constitutes the necessary medical
information that must be communicated to a receiving facility to meet
the patient's post-hospitalization health care goals, support
continuity in the patient's care, and reduce the likelihood of hospital
readmission. Moreover, we intend to align these data elements with the
common clinical data set published in the ``2015 Edition of Health
Information Technology (Health IT) Certification Critieria, Base
Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications'' final rule (80 FR 62601, October
16, 2015). By aligning the data elements proposed in this proposed rule
with the common clinical data set specified for the 2015 edition, we
are seeking to ensure that hospitals can meet these requirements using
certified health IT systems and existing standards. Therefore, we
propose, at the minimum, the following information to be provided to a
receiving facility:
Demographic information, including but not limited to
name, sex, date of birth, race, ethnicity, and preferred language;
Contact information for the practitioner responsible for
the care of the patient and the patient's caregiver/support person(s);
Advance directive, if applicable;
Course of illness/treatment;
Procedures;
Diagnoses;
Laboratory tests and the results of pertinent laboratory
and other diagnostic testing;
Consultation results;
Functional status assessment;
Psychosocial assessment, including cognitive status;
Social supports;
Behavioral health issues;
Reconciliation of all discharge medications with the
patient's pre-hospital
admission/registration medications (both prescribed and over-the-
counter);
All known allergies, including medication allergies;
Immunizations;
Smoking status;
Vital signs;
Unique device identifier(s) for a patient's implantable
device(s), if any;
All special instructions or precautions for ongoing care,
as appropriate;
Patient's goals and treatment preferences; and
All other necessary information to ensure a safe and
effective transition of care that supports the post-discharge goals for
the patient.
In addition to these proposed minimum elements, necessary
information must also include a copy of the patient's discharge
instructions, the discharge summary, and any other documentation that
would ensure a safe and effective transition of care, as applicable.
While we are not proposing a specific form, format, or methodology
for the communication of this information for all facilities, we
strongly believe that those facilities that are electronically
capturing information should be doing so using certified health IT that
will enable real time electronic exchange with the receiving provider.
By using certified health IT, facilities can ensure that they are
transmitting interoperable data that can be used by other settings,
supporting a more robust care coordination and higher quality of care
for patients. We are soliciting comments on these proposed medical
information requirements.
We note that HHS has a number of initiatives designed to encourage
and support the adoption of health information technology and to
promote nationwide health information exchange to improve the quality
of health care. HHS believes all patients, their families, and their
healthcare providers should have consistent and timely access to health
information in a standardized format that can be securely exchanged
between the patient, providers, and others involved in the patient's
care.\8\ ONC recently released a document entitled ``Connecting Health
and Care for the Nation: A Shared Nationwide Interoperability Roadmap''
(https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf). The Roadmap
identifies four critical pathways that health IT stakeholders should
focus on now in order to create a foundation for long-term success: (1)
Improve technical standards and implementation guidance for priority
data domains and associated elements; (2) rapidly shift and align
federal, state, and commercial payment policies from fee-for-service to
value-based models to stimulate the demand for interoperability; (3)
clarify and align federal and state privacy and security requirements
that enable interoperability; and (4) align and promote the use of
consistent policies and business practices that support
interoperability and address those that impede interoperability, in
coordination with stakeholders. In the near term, the roadmap focuses
on ensuring individuals and providers across the continuum of care can
send, receive, find and use priority data domains to improve health
care quality and outcomes.
---------------------------------------------------------------------------
\8\ (HHS August 2013 Statement, ``Principles and Strategies for
Accelerating Health Information Exchange.'')
---------------------------------------------------------------------------
These initiatives are designed to encourage HIE among all health
care providers, including those who are not eligible for the Electronic
Health Record (EHR) Incentive Programs, and are designed to improve
care delivery and coordination across the entire care continuum. Our
revisions to this rule are intended to recognize the advent of
electronic health information technology and to accommodate and support
adoption of ONC certified health IT and interoperability standards. We
believe that the use of this technology can effectively and efficiently
help facilities and other providers improve internal care delivery
practices, support the exchange of important information across care
team members (including patients and caregivers) during transitions of
care, and enable reporting of electronically specified clinical quality
measures (eCQMs). For more information on guidance for ineligible
providers, we direct stakeholders to the ONC guidance for EHR
technology developers serving
[[Page 68137]]
providers ineligible for the Medicare and Medicaid EHR Incentive
Programs titled ``Certification Guidance for EHR Technology Developers
Serving Health Care Providers Ineligible for Medicare and Medicaid EHR
Incentive Payments.'' (http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_&9-9-13.pdf).
This guidance will be updated as new editions of certification
criteria are released.
Additionally, we propose that the requirement and the timeframe for
communicating necessary information for patients being transferred to
another healthcare facility remain the same as in the current
requirement. That is, hospitals would continue to be required to
provide this information at the time of the patient's discharge and
transfer to the receiving facility. Hospitals are encouraged to
consider adapting or incorporating electronic tools (or both) to
facilitate and streamline information that would fulfill the proposed
discharge requirements to ensure a successful transfer of care.
Hospitals are also encouraged to continue the practice of direct
communication between the sending and receiving facilities. Clinician-
to-clinician contact to discuss the patient's transfer, review
information provided by the sending facility, and answer follow-up
questions can help smooth the transfer process for the patient and the
facilities. We believe that this direct communication is beneficial for
all parties, and that this practice should continue to be used in
addition to our proposed information-exchange requirements.
6. Requirements for Post-Acute Care Services (Proposed Sec. 482.43(f))
We propose to re-designate and revise the requirements of current
Sec. 482.43(c)(6) through (8) at new Sec. 482.43(f), ``Requirements
for post-acute care services.'' This standard is based in part on
specific statutory requirements located at sections 1861(ee)(2)(H) and
1861(ee)(3) of the Act, with the addition of IRF and LTCH PAC providers
in the regulatory text, in order to provide consistency with the IMPACT
Act. The current regulation directs hospitals to provide a list of
available Medicare-participating HHAs or SNFs to patients for whom home
health care or PAC services are indicated. We are proposing that for
patients who are enrolled in managed care organizations, the hospital
must make the patient aware that they need to verify the participation
of HHAs or SNFs in their network. If the hospital has information
regarding which providers participate in the managed care
organization's network, it must share this information with the
patient. The hospital must document in the patient's medical record
that the list was presented to the patient. The patient or their
caregiver/support persons must be informed of the patient's freedom to
choose among providers and to have their expressed wishes respected,
whenever possible. The final component of the retained provision would
be the hospital's disclosure of any financial interest in the referred
HHA or SNF. However, this section would be revised to include IRFs and
LTCHs.
B. Home Health Agency Discharge Planning
Under the authority of sections 1861(m), 1861(o), and 1891 of the
Act, the Secretary has established in regulations the requirements that
a HHA must meet to participate in the Medicare program. Home health
services are covered for qualifying elderly and people with
disabilities who are entitled to benefits under the Hospital Insurance
(Medicare Part A) and/or Supplementary Medical Insurance (Medicare Part
B) programs. These services include skilled nursing care; physical,
occupational, and speech therapy; medical social work; and home health
aide services. Such services must be furnished by, or under arrangement
with, an HHA that participates in the Medicare program and must be
provided in the beneficiary's home.
On October 9, 2014, we published a proposed rule to reorganize the
current CoPs for HHAs (79 FR 61163). The proposed requirements focused
on the care delivered to patients by HHAs, reflected an
interdisciplinary view of patient care, allowed HHAs greater
flexibility in meeting quality care standards, and eliminated
burdensome procedural requirements. The proposed changes were an
integral part of our overall effort to achieve broad-based, measurable
improvements in the quality of care furnished through the Medicare and
Medicaid programs, while at the same time eliminating unnecessary
procedural burdens on providers. The October 9, 2014 proposed rule
included a proposal to update the discharge or transfer summary CoPs
for HHAs. Specifically, we proposed to specify the content of a
discharge or transfer summary, and we proposed specific timelines for
sending the discharge or transfer summary information to the follow-up
care providers. We proposed these changes as two separate sections
located at Sec. 484.60(e) and Sec. 484.110(a)(6).
The IMPACT Act was signed on October 6, 2014 and requires the
Secretary to publish regulations to modify CoPs and to develop
interpretive guidance to require that HHAs take into account quality
measures, resource use measures, and other measures to assist PAC
providers, patients, and the families of patients with discharge
planning, and to address the treatment preferences of patients and
caregivers/support person(s) and the patient's goals of care. As part
of our efforts to update the current discharge planning/discharge
summary requirements for several providers, we have revised the
previously proposed discharge or transfer summary requirements for HHAs
in this proposed rule to incorporate the requirements of the IMPACT
Act. Therefore, we are withdrawing the proposed discharge summary
content requirements at Sec. 484.60(e) that were published in the
October 9, 2014 proposed rule and are proposing to add a new standard
at Sec. 484.58 for discharge planning for HHAs.
The current regulations at Sec. 484.48 require HHAs to prepare a
discharge summary that includes the patient's medical and health status
at discharge, include the discharge summary in the patient's clinical
record, and send the discharge summary to the attending physician upon
request. We propose to update the discharge summary requirements by
requiring that HHAs better prepare patients and their caregiver/support
person(s) (or both) to be active participants in self-care and by
implementing requirements that would improve patient transitions from
one care environment to another, while maintaining continuity in the
patient's plan of care. We therefore propose to add Sec. 484.58, which
would require that HHAs develop and implement an effective discharge
planning process that focuses on preparing patients and caregivers/
support person(s) to be active partners in post-discharge care,
effective transition of the patient from HHA to post-HHA care, and the
reduction of factors leading to preventable readmissions.
In this proposed rule, we further address the content and timing
requirements for the discharge or transfer summary for HHAs. These
proposed changes incorporate the requirements of the IMPACT Act.
We are soliciting comments on the timeline for HHA implementation
of the following proposed discharge planning requirements.
[[Page 68138]]
1. Discharge Planning Process (Proposed Sec. 484.58(a))
We propose to establish a new standard, ``Discharge planning
process,'' to require that the HHA's discharge planning process ensure
that the discharge goals, preferences, and needs of each patient are
identified and result in the development of a discharge plan for each
patient. In addition, we propose to require that the HHA discharge
planning process require the regular re-evaluation of patients to
identify changes that require modification of the discharge plan, in
accordance with the provisions for updating the patient assessment at
current Sec. 484.55. The discharge plan must be updated, as needed, to
reflect these changes.
We remind HHAs that they must continue to abide by federal civil
rights laws, including Title VI of the Civil Rights Act of 1964, the
Americans with Disabilities Act, and section 504 of the Rehabilitation
Act of 1973, when developing a discharge planning process. To this end,
HHAs should take reasonable steps to provide individuals with limited
English proficiency or other communication barriers, or physical,
mental, cognitive, or intellectual disabilities meaningful access to
the discharge planning process, as required under Title VI of the Civil
Rights Act, as implemented under 45 CFR 80.3(b)(2). Discharge planning
would be of little value to patients who cannot understand or
appropriately follow the discharge plans discussed in this rule.
Without appropriate language assistance or auxiliary aids and services,
discharge planners would not be able to fully involve the patient and
caregiver/support person in the development of the discharge plan.
Furthermore, the discharge planner would not be fully aware of the
patient's goals for discharge.
We propose to require that the physician responsible for the home
health plan of care be involved in the ongoing process of establishing
the discharge plan. We believe that physicians have an important role
in the discharge planning process and we would expect that the HHA
would be in communication with the physician during the discharge
planning process. We also propose to require that the HHA consider the
availability of caregivers/support persons for each patient, and the
patient's or caregiver's capacity and capability to perform required
care, as part of the identification of discharge needs. Furthermore, in
order to incorporate patients and their families in the discharge
planning process, we propose to require that the discharge plan address
the patient's goals of care and treatment preferences.
For those patients that are transferred to another HHA or who are
discharged to a SNF, IRF, or LTCH, we propose to require that the HHA
assist patients and their caregivers in selecting a PAC provider by
using and sharing data that includes, but is not limited to HHA, SNF,
IRF, or LTCH data on quality measures and data on resource use
measures. We would expect that the HHA would be available to discuss
and answer patient's and their caregiver's questions about their post-
discharge options and needs. Furthermore, the HHA must ensure that the
PAC data on quality measures and data on resource use measures are
relevant and applicable to the patient's goals of care and treatment
preferences.
As required by the IMPACT Act, HHAs must take into account data on
quality measures and resource use measures during the discharge
planning process. In order to increase patient involvement in the
discharge planning process and to incorporate patient preferences, we
propose that HHAs provide data on quality measures and resource use
measures to the patient and caregiver that are relevant to the
patient's goals of care and treatment preferences. For example, the HHA
could provide the aforementioned quality data on other PAC providers
that are within the patient's desired geographic area. HHAs should then
assist patients as they choose a high quality PAC provider by
discussing and answering patient's and their caregiver's questions
about their post-discharge options and needs. We would expect that HHAs
would not make decisions on PAC services on behalf of patients and
their families and caregivers and instead focus on person-centered care
to increase patient participation in post-discharge care decision
making. Person-centered care focuses on the patient as the locus of
control, supported in making their own choices and having control over
their daily lives.
We propose to require that the evaluation of the patient's
discharge needs and discharge plan be documented and completed on a
timely basis, based on the patient's goals, preferences, and needs, so
that appropriate arrangements are made prior to discharge or transfer.
This requirement would prevent the patient's discharge or transfer from
being unduly delayed. In response to this requirement, we would expect
that HHAs would establish more specific time frames for completing the
evaluation and discharge plans based on their patient's needs and
taking into consideration the patient's acuity level and time spent in
home health care. We propose to require that the evaluation be included
in the clinical record. We propose that the results of the evaluation
be discussed with the patient or patient's representative. Furthermore,
all relevant patient information available to or generated by the HHA
itself must be incorporated into the discharge plan to facilitate its
implementation and to avoid unnecessary delays in the patient's
discharge or transfer.
2. Discharge or Transfer Summary Content (Proposed Sec. 484.58(b))
We propose at Sec. 484.58(b) to establish a new standard,
``Discharge or transfer summary content,'' to require that the HHA send
necessary medical information to the receiving facility or health care
practitioner. The information must include, at the minimum, the
following:
Demographic information, including but not limited to
name, sex, date of birth, race, ethnicity, and preferred language;
Contact information for the physician responsible for the
home health plan of care;
Advance directive, if applicable;
Course of illness/treatment;
Procedures;
Diagnoses;
Laboratory tests and the results of pertinent laboratory
and other diagnostic testing;
Consultation results;
Functional status assessment;
Psychosocial assessment, including cognitive status;
Social supports;
Behavioral health issues;
Reconciliation of all discharge medications (both
prescribed and over-the-counter);
All known allergies, including medication allergies;
Immunizations;
Smoking status;
Vital signs;
Unique device identifier(s) for a patient's implantable
device(s), if any;
Recommendations, instructions, or precautions for ongoing
care, as appropriate;
Patient's goals and treatment preferences;
The patient's current plan of care, including goals,
instructions, and the latest physician orders; and
Any other information necessary to ensure a safe and
effective transition of care that supports the post-discharge goals for
the patient.
As part of the medication reconciliation process, we encourage
[[Page 68139]]
practitioners to consult with their state's PDMP. In section II.A.3 of
this proposed rule, we discuss the potential benefits as well as the
challenges associated with the use of PDMPs. Given these potential
benefits and challenges, we are soliciting comments on whether, as part
of the medication reconciliation process, practitioners should be
required to consult with their state's PDMP to reconcile patient use of
controlled substances as documented by the PDMP, even if the
practitioner is not going to prescribe a controlled substance.
We propose to include these elements in the discharge plan so that
there is a clear and comprehensive summary for effective and efficient
follow-up care planning and implementation as the patient transitions
from HHA services to another appropriate health care setting.
We note that many of the aforementioned proposed medical
information elements required to be sent to the receiving facility or
health care practitioner may not be applicable to the patient.
Therefore, we would expect HHAs to include this information with a ``N/
A'' or other appropriate notation next to each data element that does
not apply to the patient. We are soliciting comments on these proposed
medical information requirements.
C. Critical Access Hospital Discharge Planning
Sections 1820(e) and 1861 (mm) of the Act provide that critical
access hospitals participating in Medicare and Medicaid meet certain
specified requirements. We have implemented these provisions in 42 CFR
part 485, subpart F, Conditions of Participation for CAHs.
Currently, there is no CAH discharge planning CoP. When CMS
established requirements for the Essential Access Community Hospital
(EACH) and Rural Primary Care Hospital (RPCH) providers that
participated in the seven-state demonstration program in 1993, a
discharge planning CoP was not developed then. Minimally, what was
required under the former EACH/RPCH program was adopted for the new CAH
program (see 62 FR 45966 through 46008, August 29, 1997). Currently the
CoPs at Sec. 485.631(c)(2)(ii) provide that a CAH must arrange for, or
refer patients to, needed services that cannot be furnished at the CAH.
CAHs are to ensure that adequate patient health records are maintained
and transferred as required when patients are referred.
As previously noted, we recognize that there is significant benefit
in improving the transfer and discharge requirements from an inpatient
acute care facility, such as CAHs and hospitals, to another care
environment. We believe that our proposed revisions would reduce the
incidence of preventable and costly readmissions, which are often due
to avoidable adverse events. In addition, under the IMPACT Act, CAHs
must take into account quality measures, resource use measures, and
other measures to assist PAC providers, patients, and the families of
patients with discharge planning, also in light of the treatment
preferences of patients and the patient's goals of care. Given these
concerns and the IMPACT Act mandate, we are proposing new CAH discharge
planning requirements. We are soliciting comments on the timeline for
implementation of the following proposed CAH discharge planning
requirements.
As discussed at length in section II.A. for hospitals, we maintain
that discharge planning is an important component of successful
transitions from the CAH setting. Due to the availability of fewer
health care resources in a rural environment, it is important to keep
CAH patients on the path to recovery by ensuring that the CAH
effectively communicates the discharge plan to the patient and those
who will be providing support to the patient post-discharge. It is
important that patients discharged to home from CAHs have the necessary
support and access to the appropriate resources to assist them with
recovery.
While we propose that CAHs must take into consideration the
patient's preferences and goals of care during the discharge planning
process, as we describe in this proposed rule, we also acknowledge that
patients located in rural areas that are discharged from CAHs may have
limited post-acute care options.
Facilities that offer the most appropriate post-discharge care for
a particular patient's recovery needs may be located outside of the
patient's community. We therefore would expect CAHs to support patients
as they choose an appropriate PAC setting that meets their preferences
and goals of care, while informing the patient of the benefits of
selecting the most appropriate setting for their post-discharge needs,
even if the facility is outside of the patient's desired location.
Consistent communication between health care providers in all
patient care settings would assist in better patient placement.
However, this level of communication has not been consistently achieved
among the numerous healthcare providers within communities across the
country. Therefore, we believe that it is vital that rural providers
collaborate with each other to optimize the use of post-discharge
providers in rural areas.
We propose to develop requirements in the form of five standards at
Sec. 485.642. We would require that all inpatients and certain
categories of outpatients be evaluated for their discharge needs and
that the CAH develop a discharge plan. We also propose to require that
the CAH provide specific discharge instructions, as appropriate, for
all patients.
We propose that each CAH's discharge planning process must ensure
that the discharge needs of each patient are identified and must result
in the development of an appropriate discharge plan for each patient.
We remind CAHs that they must continue to abide by federal civil
rights laws, including Title VI of the Civil Rights Act of 1964, the
Americans with Disabilities Act, and section 504 of the Rehabilitation
Act of 1973, when developing a discharge planning process. To this end,
CAHs should take reasonable steps to provide individuals with limited
English proficiency or physical, mental, cognitive, and intellectual
disabilities meaningful access to the discharge planning process, as
required under Title VI of the Civil Rights Act, as implemented at 45
CFR Sec. 80.3(b)(2). Discharge planning would be of little value to
patients who cannot understand or appropriately follow the discharge
plans discussed in this rule. Without appropriate language assistance
or auxiliary aids and services, discharge planners would not be able to
fully involve the patient and caregiver/support person in the
development of the discharge plan. Furthermore, the discharge planner
would not be fully aware of the patient's goals for discharge.
Additionally, effective discharge planning will assist CAHs in
accordance with the U.S. Supreme Court's holding in Olmstead vs. L.C.,
which found that the unjustified segregation of people with
disabilities is a form of unlawful discrimination under the ADA. We
note that effective discharge planning may assist CAHs in ensuring that
individuals being discharged, who would otherwise be entitled to
institutional services, have access to community based services when:
(a) such placement is appropriate; (b) the affected person does not
oppose such treatment; and (c) the placement can be reasonably
accommodated.
1. Design (Proposed Sec. 485.642(a))
We propose at Sec. 485.642(a) to establish a new standard,
``Design,'' to require a CAH to have policies and
[[Page 68140]]
procedures that are developed with input from the CAH's professional
healthcare staff, nursing leadership as well as other relevant
departments. The policies and procedures must be approved by the
governing body or responsible individual and be specified in writing
(see proposed Sec. 482.43).
2. Applicability (Proposed Sec. 485.642(b))
We propose at Sec. 485.642(b) to establish a new standard,
``Applicability'', to require the CAH's discharge planning process to
identify the discharge needs of each patient and to develop an
appropriate discharge plan. We note that, in accordance with section
1814(a)(8) of the Act and Sec. 424.15, physicians must certify that
the individual may reasonably be expected to be discharged or
transferred to a hospital within 96 hours after admission to the CAH.
We propose to require that the discharge planning process must apply to
all inpatients, observation patients, patients undergoing surgery or
same-day procedures where anesthesia or moderate sedation was used,
emergency department patients identified as needing a discharge plan,
and any other category of patients as recommended by the professional
healthcare staff and approved by the governing body or responsible
individual.
3. Discharge Planning Process (Proposed Sec. 485.642(c))
We propose at Sec. 485.642(c), ``Discharge planning process,'' to
require that CAHs implement a discharge planning process to begin
identifying the anticipated post-discharge goals, preferences, and
discharge needs of the patient and begin to develop an appropriate
discharge plan for the patients identified in proposed Sec.
485.642(b). We propose at Sec. 485.642(c)(1) to require that a
registered nurse, social worker, or other personnel qualified in
accordance with the CAH's discharge planning policies must coordinate
the discharge needs evaluation and development of the discharge plan.
We also propose at Sec. 485.642(c)(2) to require that the discharge
planning process begin within 24 hours after admission or registration
for each applicable patient identified under the proposed requirement
at Sec. 485.642(b), and is completed prior to discharge home or
transfer to another facility, without unduly delaying the patient's
discharge or transfer. If the patient's stay was less than 24 hours,
the discharge needs would be identified prior to the patient's
discharge home or transfer to another facility and without
unnecessarily delaying the patient's discharge or transfer. We note
that this policy does not pertain to emergency-level transfers for
patients who require a higher level of care. However, while an
emergency-level transfer would not need a discharge evaluation and
plan, we would expect that the CAH would send necessary and pertinent
information with the patient that is being transferred to another
facility.
We propose at Sec. 485.642(c)(3) that the CAH's discharge planning
process must require regular reevaluation of patients to identify
changes that require modification of the discharge plan. The discharge
plan must be updated, as needed to reflect these changes. We propose at
Sec. 485.642(c)(4) that the practitioner responsible for the care of
the patient must be involved in the ongoing process of establishing the
discharge plan.
We propose at Sec. 485.642(c)(5) that the CAH would be required to
consider caregiver/support person availability and community based
care, and the patient's or caregiver's/support person's capability to
perform required care including self-care, follow-up care from a
community based provider, care from a support person(s), care from and
being discharged back to community-based health care providers and
suppliers, or, in the case of a patient admitted from a long term care
or other residential facility, care in that setting, as part of the
identification of discharge needs. We also propose to require that CAHs
must consider the availability of and access to non-health care
services for patients, which may include home and physical environment
modifications, transportation services, meal services, or household
services, including housing for homeless patients. In addition, we
encourage CAHs to consider the availability of supportive housing, as
an alternative to homeless shelters that can facilitate continuity of
care for patients in need of housing.
As part of the on-going discharge planning process, we propose in
Sec. 485.642(c)(5) that CAHs would need to identify areas where the
patient or caregiver/support person(s) would need assistance and
address those needs in the discharge plan. CAHs must consider the
following in evaluating a patient's discharge needs including but not
limited to:
Admitting diagnosis or reason for registration;
Relevant co-morbidities and past medical and surgical
history;
Anticipated ongoing care needs post-discharge;
Readmission risk;
Relevant psychosocial history;
Communication needs, including language barriers,
diminished eyesight and hearing, and self-reported literacy of the
patient, patient's representative or caregiver/support person(s), as
applicable;
Patient's access to non-health care services; and
community-based care providers; and
Patient's goals and preferences.
We refer readers to Section II. A. 3 for a more detailed
explanation of our expectations for this requirement and for additional
resources.
During the evaluation of a patient's relevant co-morbidities and
past medical and surgical history, we encourage practitioners to
consult with their state's PDMP. In section II.A.3 of this proposed
rule, we discuss the potential benefits as well as the challenges
associated with the use of PDMPs. Given these potential benefits and
challenges, we are soliciting comments on whether practitioners should
be required to consult with their state's PDMP and review a patient's
risk of non-medical use of controlled substances and substance use
disorders as indicated by the PDMP report.
We propose at Sec. 485.642 (c)(6) that the patient and caregiver/
support person(s) would be involved in the development of the discharge
plan, and informed of the final plan to prepare them for their post-CAH
care.
We propose at Sec. 485.642 (c)(7) to require that the patient's
discharge plan address the patient's goals of care and treatment
preferences. During the discharge planning process, we would expect
that the appropriate staff would discuss the patient's post-acute care
goals and treatment preferences with the patient, the patient's family
or the caregiver (or both) and subsequently document these goals and
preferences in the discharge plan. These goals and treatment
preferences should be taken into account throughout the entire
discharge planning process.
We propose at Sec. 485.642(c)(8) to require that CAHs assist
patients, their families, or their caregiver's/support persons in
selecting a PAC provider by using and sharing data that includes, but
is not limited to, HHA, SNF, IRF, or LTCH, data on quality measures and
data on resource use measures. We would expect that the CAH would be
available to discuss and answer patients and their caregiver's
questions about their post-discharge options and needs. We would also
expect the CAH to document in the medical record that the quality
measures and resource use measures were shared with the patient and
used to assist the patient during the discharge planning process.
[[Page 68141]]
Furthermore, the CAH would have to ensure that the PAC data on
quality measures and data on resource use measures is relevant and
applicable to the patient's goals of care and treatment preferences.
As required by the IMPACT Act, CAHs would have to take into account
data on quality measures and data on resource use measures during the
discharge planning process. In order to increase patient involvement in
the discharge planning process and to emphasize patient preferences
throughout the patient's course of treatment, CAHs should tailor the
data on PAC provider quality measures and resource use measures to the
patient's goals of care and treatment preferences. For example, the CAH
could provide the aforementioned quality data on PAC providers that are
within the patient's desired geographic area. In another instance, CAHs
could provide quality data on HHAs based on the patient's preference to
continue their care upon discharge to home. CAHs should assist patients
as they choose a high quality PAC provider. However, we would expect
that CAHs would not make decisions on PAC services on behalf of
patients and their families and caregivers and instead focus on person-
centered care to increase patient participation in post-discharge care
decision making. Person-centered care focuses on the patient as the
locus of control, supported in making their own choices and having
control over their daily lives.
We propose at Sec. 485.642(c)(9) to require that the evaluation of
the patient's discharge needs and discharge plan would have to be
documented and completed on a timely basis, based on the patient's
goals, preferences, strengths, and needs. This will ensure that
appropriate arrangements for post-CAH care are made before discharge.
We believe that the CAH would establish more specific time frames for
completing the evaluation and discharge plans based on the needs of
their patients and their own operations. We propose to require that the
evaluation be included in the medical record. The results of the
evaluation must be discussed with the patient or patient's
representative. All relevant patient information would have to be
incorporated into the discharge plan to facilitate its implementation
and to avoid unnecessary delays in the patient's discharge or transfer.
We also propose at Sec. 485.642(c)(10) to require that the CAH
assess its discharge planning process in accordance with the existing
requirements at Sec. 485.635(a)(4). The assessment must include
ongoing, periodic review of a representative sample of discharge plans,
including those patients who were readmitted within 30 days of a
previous admission to ensure that they are responsive to patient
discharge needs.
4. Discharge to Home (Proposed Sec. 485.642(d)(1) through (3))
We propose at Sec. 485.642(d)(1) to establish a new standard,
``Discharge to home'', to require that discharge instructions be
provided at the time of discharge to the patient, or the patient's
caregiver/support person (or both). Also, if the patient is referred to
a PAC provider or supplier, the discharge instructions must be provided
to the PAC provider/supplier. Instruction on post-discharge care must
include, but are not limited to, instruction on post-discharge care to
be used by the patient or the caregiver/support person(s) in the
patient's home, as identified in the discharge plan. We also propose at
Sec. 485.642(d)(2) to require that the instructions must include:
Instruction on post-discharge care to be used by the
patient or the caregiver/support person(s) in the patient's home, as
identified in the discharge plan;
Written information on warning signs and symptoms that may
indicate the need to seek immediate medical attention;
Prescriptions for medications that are required after
discharge, including the name, indication, and dosage of each drug
along with any significant risks and side effects of each drug as
appropriate to the patient;
Reconciliation of all discharge medications with the
patient's pre-hospital admission/registration medications (both
prescribed and over-the counter); and
Written instructions regarding the patient's follow-up
care, appointments, pending or planned diagnostic tests (or both), and
pertinent contact information, including telephone numbers for
practitioners involved in follow-up care.
As part of the medication reconciliation process, we encourage
practitioners to consult with their state's PDMP. In section II.A.3 of
this proposed rule, we discuss the potential benefits as well as the
challenges associated with the use of PDMPs. Given these potential
benefits and challenges, we are soliciting comments on whether, as part
of the medication reconciliation process, practitioners should be
required to consult with their state's PDMP to reconcile patient use of
controlled substances as documented by the PDMP, even if the
practitioner is not going to prescribe a controlled substance.
In addition to the patient receiving discharge instructions, it is
important that the providers responsible for follow-up care with a
patient (including the PCP or other practitioner) receive the necessary
medical information to support continuity of care. We therefore propose
at Sec. 485.642(d)(3) to require that the CAH send the following
information to the practitioner(s) responsible for follow up care, if
the practitioner is known to the hospital and has been clearly
identified:
A copy of the discharge instructions and the discharge
summary within 48 hours of the patient's discharge;
Pending test results within 24 hours of their
availability;
All other necessary information as specified in proposed
Sec. 485.642(e)(2).
We remind CAHs to provide this information in a manner that
complies with all applicable privacy and security regulations. We would
expect that discharge instructions would be carefully designed and
written in plain language and designed to be easily understood by the
patient or the patient's caregiver/support person (or both). In
addition, as a best practice, CAHs should confirm patient or the
patient's caregiver/support person (or both) understanding of the
discharge instructions. We recommend that CAHs consider the use of
``teach-back'' during discharge planning and upon providing discharge
instructions to the patient. We refer readers to Section II. A. 3 for
more resources on the ``teach-back'' method.
We propose at Sec. 485.642(d)(4) to require CAHs to establish a
post-discharge follow-up process. We believe that post-discharge
follow-up can help ensure that patients comprehend and adhere to their
discharge instruction and medication regimens and improve patient
safety and satisfaction. We are proposing that CAHs have the
flexibility to determine the appropriate time and mechanism of the
follow up process to meet the needs of their patients. However, we note
the importance of ensuring that CAHs follow-up, post-discharge, with
their most vulnerable patients, including those with behavioral health
conditions.
5. Transfer of Patients to Another Health Care Facility (Proposed Sec.
485.642(e))
When a patient is transferred to another facility, that is another
CAH, hospital, or a PAC provider, we propose at Sec. 485.642(e) to
require that the CAH send necessary medical information to the
receiving facility at the time of transfer. The necessary medical
information must include:
[[Page 68142]]
Demographic information, including but not limited to
name, sex, date of birth, race, ethnicity, and preferred language;
Contact information for the practitioner responsible for
the care of the patient as described at paragraph (b)(4) of this
section and the patient's caregiver/support person(s);
Advance directive, if applicable;
Course of illness/treatment;
Procedures;
Diagnoses;
Laboratory tests and the results of pertinent laboratory
and other diagnostic testing;
Consultation results;
Functional status assessment;
Psychosocial assessment, including cognitive status;
Social supports;
Behavioral health issues;
Reconciliation of all discharge medications with the
patient's pre-hospital admission/registration medications (both
prescribed and over-the-counter);
All known allergies; including medication allergies;
Immunizations;
Smoking status;
Vital signs;
Unique device identifier(s) for a patient's implantable
device (s), if any;
All special instructions or precautions for ongoing care;
as appropriate;
Patient's goals and treatment preferences; and
Any other necessary information including a copy of the
patient's discharge instructions, the discharge summary, and any other
documentation as applicable, to ensure a safe and effective transition
of care that supports the post-discharge goals for the patients.
We have discussed the rationale for these provisions in our
discussion of the hospital provisions in section II.A. We are
soliciting comments on these proposed medical information requirements.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 60-days notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. ICRs Regarding Hospital Discharge Planning (Sec. 482.43)
Proposed Sec. 482.43(b) would require that the discharge process
applies to all inpatients and to all outpatients identified at Sec.
482.43(b)(2) through (5). The current hospital CoPs at Sec. 482.43(a)
require hospitals to have a discharge planning process for patients
that have been identified as likely to suffer adverse health
consequences upon discharge if there is no adequate discharge planning
and for patients who have discharge planning requested by themselves,
someone else who is acting on their behalf, or their physician for
actual discharge planning. Thus, since hospitals would shift from
evaluating patients for potential discharge planning to actually
providing a discharge plan for the vast majority of patients, hospitals
would have to revise their policies and procedures to comply with the
proposed requirements in this section.
It should be noted here that the proposed requirements at Sec.
482.43(c)(8) and Sec. 482.43(c)(9) (and all similar proposed
requirements set out at proposedSec. 485.642(c)(8) and (9) for CAHs
and Sec. 484.58(a)(6) and (7) for HHAs), which correspond to the
requirements of the IMPACT Act, are exempted from the application of
the PRA pursuant to section 1899B(m). Therefore, we are not required to
estimate the public reporting burden for information collection
requirements for these specific elements of the proposed rule in
accordance with chapter 35 of title 44, United States Code. Nor are we
required to undergo the specific public notice requirements of the PRA.
Therefore, the estimates we provide in the Regulatory Impact Analysis
(RIA) section of this proposed rule are essentially identical to those
we would estimate under the PRA with respect to the elements set out in
section 1899B of the Act. The public comment period on the proposed
rule will give those affected an equivalent opportunity with the
greater procedural benefits of the Administrative Procedure Act and
Executive Order 12866. The exemption created by the IMPACT Act does not
exempt the entirety of this proposed rule from PRA analysis. We further
note that these proposed rules deal with the transmission of data on
quality measures and data on resource use measures to patients that,
are provided by the government to health care providers, not with the
costs associated with its preparation. This rule does not deal with
those costs.
Proposed Sec. 482.43(d) would require hospitals to provide to all
patients discharged to home, with or without a referral to a community-
based service provider, discharge instructions that must include, at a
minimum, those items identified in Sec. 482.43(d)(2)(i) through (v).
The current hospital CoPs do not contain any requirements for written
discharge instructions under that heading. However, there are
requirements for hospitals to provide certain information to patients.
There is a requirement that ``the patient and family members or
interested persons must be counseled to prepare them for post-hospital
care'' (Sec. 482.43(c)(5)). When a hospital transfers or refers a
patient, they must send the necessary medical information to the
appropriate facility or outpatient service, as needed, for follow-up or
ancillary care (Sec. 482.43(d)). When appropriate, there are
requirements to provide lists of available providers, such as home
health providers, to patients (Sec. 482.43(c)(6)). Thus, hospitals are
already providing counseling to patients, their families, or other
interested parties and are providing certain written information.
Whenever a patient is discharged or transferred to another
facility, proposed Sec. 482.43(e) would require hospitals to send
necessary medical information to the receiving facility at the time of
transfer. The necessary information that the hospital must send to the
receiving facility includes all the items listed at proposed Sec.
482.43(e)(2)(i) through (viii). The current hospital CoPs already
require hospitals to send along with any patient that is transferred or
referred to another facility the necessary medical information for the
patient's follow-up or ancillary care to the appropriate facility
(Sec. 482.43(d)). Overall, we believe that almost all of the proposed
changes for hospitals constitute a clarification and restatement of the
current requirements along with their interpretive guidelines, or
simply state as requirements practices that most hospitals already
follow for most patients. For example, we believe that
[[Page 68143]]
medication reconciliation is a near universal practice for inpatients.
Thus, we believe that hospitals are already following most of these
proposed requirements and therefore we will not be assessing any
additional burden for this section beyond our estimates of the one-time
cost to hospitals to modify their policies and procedures in order to
ensure that they are meeting the requirements of this proposed rule.
There are, however, some proposed requirements that expand beyond
current practice, or that fewer hospitals currently follow. These
proposed requirements included:
Discharge plans for certain categories of outpatients,
including, but not limited to patients receiving observation services,
patients who are undergoing surgery or other same-day procedures where
anesthesia or moderate sedation is used, emergency department patients
who have been identified by a practitioner as needing a discharge plan,
and any other category of outpatient as recommended by the medical
staff, approved by the governing body and specified in the hospital's
discharge planning policies and procedures; and
The practitioner responsible for the care of the patient
must be involved in the ongoing process of establishing the patient's
goals of care and treatment preferences that inform the discharge plan,
just as they are with other aspects of patient care during the
hospitalization or outpatient visit.
In the estimates that follow in this section of the preamble and in
the RIA, we estimate hourly costs. Using data from the Bureau of Labor
Statistics, we have estimates of the national average hourly wage for
all medical professions (for an explanation of these data see http://www.bls.gov/news.release/archives/ocwage_03252015.htm). These data do
not include the employer share of fringe benefits such as health
insurance and retirement plans, the employer share of OASDI taxes, or
the overhead costs to employers for rent, utilities, electronic
equipment, furniture, human resources staff, and other expenses that
are incurred for employment. The HHS-wide practice is to account for
all such costs by adding 100 percent to the hourly cost rate, doubling
it for purposes of estimating the costs of regulations.
With respect to the one-time costs of reviewing the newly stated
requirements and of reviewing and in some cases modifying existing
procedures to come into compliance, we estimate that this would require
a physician, a registered nurse, and an administrator using the average
hourly salaries as estimated in this proposed rule. We estimate that
each person would spend 8 hours on this activity for a total of 24
hours per hospital at a cost of $3,424 ((8 hours x $67 for a registered
nurse's hourly salary) + (8 hours x $174 for hospital CEO/
administrator's hourly salary) + (8 hours x $187 for a physician's
hourly salary)). The total burden hours are 117,600 (24 hours x 4,900
hospitals). For all hospitals to comply with this requirement, we
estimate a total one-time cost of approximately $17 million (4,900
hospitals x $3,424). These time estimates are based on our best
estimates of the time needed, on average, to review the final rule,
compare its provisions with current practice at the hospital, and
determine what changes would be needed and what instructions would need
to be issued. For some hospitals, less time would be needed, and for
some hospitals more, depending on current practices. These estimates
are based on the judgments of CMS staff involved in the Survey and
Certification process. We are unaware of any ``time and motion'' or
similar studies that would provide a quantitative and reliable source
for such estimates. We welcome comments and data that would help us
improve the estimates.
For the requirements that exceed current practice or that are not
universally followed, we use the following cost assumptions, based on
the following hourly salaries: physician at $187; registered nurse at
$67; Advanced Practice Registered Nurse (APRN) at $94; Physicians
Assistant (PA) at $94; and healthcare social worker at $52. We would
expect a registered nurse and healthcare social worker to carry out the
duties of evaluating and planning for a patient's discharge while we
would expect a physician, APRN, or PA to fulfill the practitioner
involvement in the discharge plan requirement.
For the estimated cost of hospitals to provide additional discharge
plans for the proposed new categories of outpatients, we started with
the most recent data from the CDC on hospital outpatient and emergency
department (ED) visits that showed approximately 126 million visits and
118 million visits (not including the 18.3 million emergency department
visits that resulted in inpatient admissions), respectively, in 2011
(http://www.cdc.gov/nchs/fastats/hospital.htm). We believe that only 5
percent of hospital outpatient visits, or approximately 6 million
visits, and 5 percent of ED visits, or approximately 6 million visits,
would need a discharge plan. We base this belief on our experience with
hospitals that shows that most outpatient visits, similar to a
physician's office visit, do not need a discharge plan of any type and
that most ED visits already receive some type of discharge plan.
Also according to the CDC, of the 34.7 million ambulatory surgery
visits in 2006, 19.9 million occurred in hospitals (http://www.cdc.gov/nchs/data/nhsr/nhsr011.pdf). For the purposes of this analysis, we
believe that approximately 95 percent of patients who undergo hospital
ambulatory surgeries would already receive discharge plans and are thus
not included in our cost estimates. Therefore, we believe that 5
percent, or 1 million, of these patients do not currently receive
discharge plans and are included in our cost estimates here.
We also have reason to believe that approximately 2 million
outpatients receive observation care annually (http: //khn.org/news/observation-care-faq/) and that all but 5 percent, or 100,000
outpatients, currently receive a discharge plan. This would then bring
our estimate of additional discharge plans annually to approximately 13
million patients.
Using the number of 13 million outpatients, we estimate the amount
of time that these discharge plans would take hospitals to develop and
provide, including the cost of the additional proposed requirements
previously noted in this proposed rule, that is, practitioner
involvement in the development of the discharge plan. We believe that
these additional requirements are already being performed for
inpatients discharged, so we have not estimated any additional cost for
these patients.
We believe that hospital APRNs and PAs would spend equal time as
physicians, RNs, and healthcare social workers on discharge planning (5
minutes or 0.083 hours) on an equal number of outpatients. We averaged
the salaries ($94 + $94 + $187 + $67 + $52)/5 = $99 per hour)). Thus,
we estimate that complying with the proposed requirements of new
outpatient discharge plans and practitioner involvement in those plans
would cost approximately $107 million annually (13 million patients x
0.083 hours x $99 average hourly wage for APRNs, PAs, MDs/Doctors of
Osteopathic Medicine (DOs), RNs, and healthcare social workers).
These estimates are based on the judgment of CMS staff as well as
our experience with hospitals, both as CMS staff and as active hospital
staff members. We welcome data and comments on these estimates.
[[Page 68144]]
B. ICRs Regarding Home Health Discharge Planning (Sec. 484.58)
We propose a new CoP at Sec. 484.58 that would require HHAs to
develop and implement an effective discharge planning process that
focuses on preparing patients to be active partners in post-discharge
care, effective transition of the patient from HHA to post-HHA care,
and the reduction of factors leading to preventable readmissions.
We propose to establish a new standard at Sec. 484.58(a),
``Discharge planning process,'' to require that the HHA's discharge
planning process ensure that the discharge needs of each patient are
identified and result in the development of a discharge plan for each
patient. In addition, we propose to require that the HHA discharge
planning process require the regular re-evaluation of patients to
identify changes that require modification of the discharge plan. The
discharge plan must be updated, as needed, to reflect these changes.
We propose to require that the physician responsible for the home
health plan of care be involved in the ongoing process of establishing
the discharge plan. We would expect that the HHA would be in
communication with the physician during the discharge planning process.
We also propose to require that as part of identifying the patient's
discharge needs, the HHA consider the availability of caregivers/
support persons for each patient whether through self-care, care from a
support person(s), care from community-based health care providers and
agencies, or care from a long-term care facility or other residential
facility as part of the identification of discharge needs. The proposed
requirement would also require the HHA to consider the patient's or
caregiver's capacity and capability to provide the necessary care.
Furthermore, in order to incorporate patients and their families in the
discharge planning process, we propose to require that the discharge
plan address the patient's goals of care and treatment preferences.
We propose to require that the evaluation of the patient's
discharge needs and discharge plan must be documented, completed on a
timely basis and be based on the patient's needs to ensure that the
patient's discharge or transfer is not unduly delayed. We believe that
HHAs would establish more specific time frames for completing the
evaluation and discharge plans based on the needs of their patients and
their own operations. We propose to require that the evaluation be
included in the medical record. We propose that the results of the
evaluation be discussed with the patient or patient's representative.
Furthermore, all relevant patient information available to or generated
by the HHA itself must be incorporated into the discharge plan to
facilitate its implementation and to avoid unnecessary delays in the
patient's discharge or transfer.
We base our HHA burden cost estimates on those discussed previously
in this proposed rule for hospitals and CAHs with the relevant
modifications for HHAs. First, HHAs would need to review their current
policies and procedures and update them so that they comply with the
requirements in proposed Sec. 484.58(a). This would be a one-time
burden on the HHA. We estimate that this would require a physician, a
registered nurse, and an administrator using the average hourly
salaries as estimated in this proposed rule. Note that we are
estimating a lower average hourly salary for an HHA administrator than
that previously estimated for a hospital CEO/administrator. We estimate
that each person would spend 8 hours on this activity for a total of 24
hours per HHA at a cost of $2,816 ((8 hours x $67 for a RN's hourly
salary) + (8 hours x $98 for an administrator's hourly salary) + (8
hours x $187 for a physician's hourly salary)). For all HHAs to comply
with this requirement, we estimate a total one-time cost of
approximately $34 million (11,930 HHAs x $2,816).
Furthermore, we believe that for a HHA to comply with the proposed
provisions for this new standard the combined services of a physician,
a registered nurse, and a social worker would be required. We use the
following average hourly costs for a physician, a registered nurse, and
a social worker respectively: $187, $67, and $52. We will also estimate
the annual burden cost by analyzing the two new proposed standards as a
combined burden in this proposed rule.
We propose at Sec. 484.58(b) to establish another new standard,
``Discharge or transfer summary content,'' to require that the HHA send
necessary medical information to the receiving facility or
practitioner. The information must include:
Demographic information, including but not limited to
name, sex, date of birth, race, ethnicity, preferred language;
Contact information for the physician responsible for the
home ehealth plan of care;
Advance directive, if applicable;
Course of illness/treatment;
Procedures;
Diagnoses;
Laboratory tests and the results of pertinent laboratory
and other diagnostic testing;
Consultation results;
Functional status assessment;
Psychosocial assessment, including cognitive status;
Social supports;
Behavioral health issues;
Reconciliaton of all discharge medications (both
prescribed and over-the counter);
All known allergies, including medication allergies;
Immunizations;
Smoking status;
Vital signs;
Unique device identifier(s) for a patient's implantable
device(s), if any;
Recommendations, instructions, or precautions for ongoing
care, as appropriate;
Patient's goals of care and treatment preferences;
The patient's current plan of care, including goals,
instructions, and the latest physician orders; and
Any other information necessary to ensure a safe and
effective transition of care that supports the post-discharge goals for
the patient.
We propose to include these elements in the discharge plan to
provide the clear and comprehensive summary that is necessary for
effective and efficient follow-up care planning and implementation as
the patient transitions from HHA services to another appropriate health
care setting.
To meet these two new proposed standards, it would take an HHA
approximately 10 minutes (0.17 hours) per patient. Of that 10 minutes,
2 minutes (0.033 hours) would be covered by the physician, 3 minutes
(0.05 hours) by the social worker, and the remaining 5 minutes (0.083
hours) by the RN. Thus, for the 11,930 HHAs, we estimate that complying
with this requirement would require 594,000 burden hours (18 million
patients x 0.033 hours) for physicians at an approximate cost of $111
million (594,000 burden hours x $187 average hourly salary); 900,000
burden hours (18 million patients x 0.05 hours) for social workers at
an approximate cost of $47 million (900,000 burden hours x $52); and
1.5 million burden hours (18 million patients x 0.083 hours) for RNs at
an approximate cost of $101 million (1.5 million burden hours x $67).
The total annual cost for all HHAs would be approximately $259 million
or $21,710 per HHA ($259,000,000/11,930 HHAs).
We also estimate that a HHA would spend 2.5 minutes per patient
sending
[[Page 68145]]
the discharge summary to the patient's next source of healthcare
services, for a total of 62 hours per average HHA annually ((2.5
minutes per patient x 1,488 patients)/60 minutes per hour) at a cost of
$1,984 for an office employee to send the required documentation ($32
per hour x 62 hours). Complying with this provision would require an
estimated 739,660 hours (62 hours per HHA x 11,930 HHAs) and $24
million ($1,984 per HHA x 11,930 HHAs) for all HHAs annually.
Thus, we estimate compliance with this new CoP would cost HHAs a
one-time cost of $34 million and approximately $283 million annually.
As previously indicated, these estimates are based on estimates for
hospitals and CAHs with the relevant modifications for HHAs. We welcome
data and comments on these estimates.
C. ICRs Regarding Critical Access Hospital Discharge Planning (Sec.
485.642)
Currently, the CoPs at Sec. 485.631(c)(2)(ii) provide that a CAH
must arrange for, or refer patients to, needed services that cannot be
furnished at the CAH. CAHs are to ensure that adequate patient health
records are maintained and transferred as required when patients are
referred.
As previously noted, we recognize that there is significant benefit
in improving the transfer and discharge requirements from an inpatient
acute care facility, such as CAHs and hospitals, to another care
environment. We believe that our proposed revisions would reduce the
incidence of preventable and costly readmissions, which are often due
to avoidable adverse events. In addition, the IMPACT Act requires that
hospitals and CAHs take into account quality, resource use data, and
other data to assist PAC providers, patients, and the families of
patients with discharge planning, while also addressing the treatment
preferences of patients and the patient's goals of care. In light of
these concerns and the requirements of the IMPACT Act, we are proposing
new CAH discharge planning requirements.
We propose to develop requirements in the form of new CoPs with
five standards at Sec. 485.642. We would require that all patients be
evaluated for their discharge needs and that the CAH develop a
discharge plan. We also propose to require that the CAH provide
specific discharge instructions, as appropriate, for all patients.
We also propose that each CAH's discharge planning process must
ensure that the discharge needs of each patient are identified and must
result in the development of an appropriate discharge plan for each
patient. The current CAH CoP at Sec. 485.635(d)(4) requires the CAH to
develop a nursing care plan for each inpatient. The Interpretive
Guidelines for Sec. 485.635(d)(4) state that the plan includes
planning the patient's care while in the CAH as well as planning for
transfer to a hospital or a PAC facility or for discharge. Because the
proposed CAH discharge planning requirements mirror those proposed for
hospitals, we believe that CAHs, like hospitals, are essentially
already performing many of the proposed requirements and estimate the
burden to be minimal. We are assessing burden only for those areas that
we believe that CAHs are not already doing under the current
requirements of the nursing care plan at Sec. 485.635(d)(4).
For proposed Sec. 485.642(b), CAHs would need to shift from
evaluating patients for potential discharge planning to actually doing
discharge planning for the vast majority of patients. CAHs would have
to revise their policies and procedures to comply with the proposed
requirements in this section. First, CAHs would need to review their
current policies and procedures and update them so that they comply
with the requirements in proposed Sec. 485.642 (b). This would be a
one-time burden on the CAH. We estimate that this would require a
physician, a registered nurse, and an administrator using the average
hourly salaries as estimated in this proposed rule. Note that we are
estimating a lower average hourly salary for a CAH administrator than
that previously estimated for a hospital CEO/administrator. We estimate
that each person would spend 16 hours on this activity for a total of
48 hours per CAH at a cost of $5,632 ((16 hours x $67 for a registered
nurse's hourly salary) + (16 hours x $98 for an administrator's hourly
salary) + (16 hours x $187 for a physician's hourly salary)). For all
CAHs to comply with this requirement, we estimate a total one-time cost
of approximately $7.5 million (1,328 CAHs x $5,632).
Similar to the proposed hospital requirements at Sec. 482.43(c),
proposed Sec. 485.642(c) would require the CAH to implement a
discharge planning process that identifies, within 24 hours after
admission or registration in the CAH, the anticipated discharge needs
for the patients identified under the proposed requirement at Sec.
485.642(b), along with several provisions supporting the requirement
proposed here.
Proposed Sec. 485.642(c) would require that the CAH's discharge
planning process promote early identification of the anticipated
discharge needs of each patient, and development of an appropriate
discharge plan for each patient for whom a discharge plan is applicable
in accordance with proposed Sec. 485.642(b). The identification of the
patient's needs and the development of the discharge plan must comply
with all of the requirements in Sec. 485.642(c)(1) through (9).
Proposed Sec. 485.642(c)(4) specifically would require that ``The
licensed practitioner responsible for the care of the patient must be
involved in the ongoing process of establishing the discharge plan.''
The current CAH CoPs do not contain any similar requirement.
The burden associated with the requirement that a practitioner
responsible for the patient's care be involved with the patient's
discharge would include the time needed for a practitioner to assist in
establishing the discharge plan. We believe that practitioner
involvement in the establishing of the discharge plan would constitute
a usual and customary business practice as defined in the implementing
regulations of the PRA at 5 CFR 320.3(b)(2) and that CAHs are already
doing this. The majority of CAHs that are deemed for participation in
Medicare are accredited by The Joint Commission, which requires a CAH
to have ``the patient, the patient's family, licensed independent
practitioners, physicians, clinical psychologists, and staff involved
in the patient's care, treatment, and services [emphasis added]
participate in planning the patient's discharge or transfer.'' Such
practitioner involvement (where indicated and where feasible) is in our
view an essential part of patient care and one that we expect CAH staff
carefully follow wherever possible. Therefore, we will not be assessing
any burden for this activity.
We believe that practitioners already are communicating with the
staff that are caring for their patients and that the practitioner's
involvement in the establishment of the discharge plan would occur
during those usual interactions with the staff. We also expect that
practitioners would review the discharge plan in conjunction with their
review of the patient's CAH medical record. The practitioner would
write the order to discharge the patient, as well as any prescriptions
for medications and other orders for the patient. However, the proposed
requirement envisions a more direct involvement in the ongoing process
of establishing a discharge plan. Thus, we believe that practitioners
would spend more time discussing the discharge plan with nurses and
other CAH personnel.
The additional time the practitioner would be required to spend on
[[Page 68146]]
discharge planning would vary greatly in accordance with the patient's
need for care, treatment, and services after he or she was discharged
from the CAH. Practitioners must already be involved in many
circumstances because they must order or authorize certain post-
discharge care. In addition, there is no need for a practitioner to
spend additional time on discharge planning for patients who only
require prescriptions for medications and an order to follow-up with
their primary care provider or those who pass away while hospitalized.
We use the following average hourly costs for a physician, an advanced
practice registered nurse, and a physician assistant respectively:
$187, $94, and $94. We believe that CAH APRNs and PAs would spend more
time than physicians on discharge planning (5 minutes versus 2 minutes
or 0.083 hours versus 0.033 hours). We estimate these practitioners
would spend more time (approximately 0.083 hours per patient) on
discharge planning for approximately 20 percent of CAH patients or
approximately 120,000 patients. We estimate physicians would spend
approximately 0.033 burden hours on 5 percent of CAH patients or
approximately 30,000 patients. Thus, we estimate that complying with
the requirements in this section would cost $1.1 million annually
((120,000 patients x 0.083 hours x $94 average hourly wage for APRNs
and PAs) + (30,000 patients x 0.033 hours x $187 average hourly wage
for physicians)).
For proposed Sec. 485.642(d), CAHs would be required to provide to
all patients discharged to home, with or without a referral to a
community-based service provider, discharge instructions that must
include, at a minimum, those items identified in Sec. 485.642(d)(2)(i)
through (v). The current CAH CoPs do not contain any requirements for
written discharge instructions.
The burden from the requirement to include discharge instructions
in the discharge plan and document those instructions is the resources
needed to develop the discharge plan and instructions. Based on our
experience with the 1,328 CAHs, we believe they are already doing some
form of discharge planning and providing discharge instructions for
most of their patients. However, we do not believe they are providing
this care for all of their patients. Of the approximately 600,000
patients discharged from CAHs each year, we estimate that about 60,000
additional patients would require discharge planning to comply with the
requirement in this section. A nurse would probably perform this
activity at an hourly salary of $67. This activity should require 30
minutes or 0.5 hours. Thus, for the 1,328 CAHs, we estimate that
complying with this requirement would require 30,000 burden hours
(60,000 patients x 0.5 hours) at a cost of $2 million (30,000 x $67
hourly nurse's salary). Approximately 5 minutes of this time would be
spent consulting with either the MD/DO or the APRN/PA at a cost of
$702,180 (60,000 patients x 0.083 hours x $141 (($187 + $94)/2),
resulting in an approximate total of $2.7 million annually.
Whenever a patient is discharged or transferred to another
facility, proposed Sec. 485.642(e) would require CAHs to send
necessary medical information to the receiving facility at the time of
transfer. The necessary information that the CAH must send to the
receiving facility includes all the items listed at proposed Sec.
485.642(e)(2)(i) through (viii). Currently, the CoPs at Sec.
485.631(c)(2)(ii) provide that a CAH must arrange for, or refer
patients to, needed services that cannot be furnished at the CAH. CAHs
are to ensure that adequate patient medical records are maintained and
transferred as required when patients are referred. We believe that
CAHs are already providing the information listed at proposed Sec.
485.642(d)(2)(i) through (viii), except for (ii), which specifically
requires an assessment of functional status, and (iv), which requires
the reconciliation of all discharge medications with the patient's pre-
CAH admission/registration medications (both prescribed and over-the
counter), including known allergies. Although we believe all CAHs are
ensuring that information about functional status and about known
allergies is being forwarded, we are not certain that they are all
reconciling the pre-CAH medications with the discharge medications.
Therefore, we will analyze a burden for this reconciliation. Since both
proposed Sec. 485.642(d)(2)(iv) and Sec. 482.642(e)(2)(iv) require
medication reconciliation, we will assess the burden for both of these
subsections together.
The burden for reconciling pre-admission/registration medications
(both prescribed and over-the-counter) with the discharge medications
would be the resources required to review the patient's chart to
identify all of a patient's pre-admission medications and compare them
to the discharge medications. Typically, a physician, nurse, or other
healthcare provider would do a history for each patient upon admission.
A nurse would usually then compare the medications the patient was
taking pre-admission to those ordered by the practitioner and reconcile
them. If there were any discrepancies that the nurse questioned, he or
she would then consult with the practitioner caring for the patient.
When a patient is ready for discharge, the nurse would then compare the
pre-admission medications with the discharge medications. If he or she
questioned any changes, the nurse would need to question the
prescribing practitioner about the discrepancy.
Based on our experience with CAHs, we believe that a nurse would
review the patient's chart and reconcile the pre-admission and
discharge medications. The time required for this reconciliation would
vary greatly depending upon the number of medications a patient was
taking, both pre-admission and at discharge, and the number of changes
or discrepancies that the nurse questioned. We estimate that this
activity would require an average of 3 minutes for each patient or 0.05
hours. We estimate that there are about 600,000 discharges annually
that would require this medication reconciliation. Nurses earn an
average hourly salary of $67. Thus, complying with this requirement
would require an estimated 30,000 burden hours (600,000 discharges x
0.05 hours per patient) across all CAHs annually at a cost of $2
million (30,000 burden hours x $67).
We welcome comments on these estimates and any available data that
we could use to improve our estimates. Based on the previously stated
estimates, to comply with all of the requirements in proposed Sec.
485.642, we estimate a total one-time cost of $7 million and a total
annual cost of approximately $6 million for CAHs nationwide.
[[Page 68147]]
Table 1--Summary of Information Collection Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Total annual Hourly labor
Regulation section(s) OMB Control Number of Number of response burden cost of Total cost ($)
No. respondents responses (hours) (hours) reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 482.43(a).......................... 0938-XXXX 4,900 4,900 8 39,200 67 2,626,400
Sec. 482.43(a).......................... 0938-XXXX 4,900 4,900 8 39,200 174 6,820,800
Sec. 482.43(a).......................... 0938-XXXX 4,900 4,900 8 39,200 187 7,330,400
Sec. 482.43(b).......................... 0938-XXXX 4,900 13,000,000 0.083 1,079,000 99 106,821,000
Sec. 484.58(a).......................... 0938-XXXX 11,930 11,930 8 95,440 67 6,394,480
Sec. 484.58(a).......................... 0938-XXXX 11,930 11,930 8 95,440 98 9,353,120
Sec. 484.58(a).......................... 0938-XXXX 11,930 11,930 8 95,440 187 17,847,280
Sec. Sec. 484.58(a) & (b).............. 0938-XXXX 11,930 18,000,000 0.033 594,000 187 111,078,000
Sec. Sec. 484.58(a) & (b).............. 0938-XXXX 11,930 18,000,000 0.05 900,000 52 46,800,000
Sec. Sec. 484.58(a) & (b).............. 0938-XXXX 11,930 18,000,000 0.083 1,494,000 67 100,098,000
Sec. Sec. 484.58(a) & (b).............. 0938-XXXX 11,930 18,000,000 0.042 756,000 32 24,192,000
Sec. 485.642(b)......................... 0938-XXXX 1,328 1,328 16 21,248 67 1,423,616
Sec. 485.642(b)......................... 0938-XXXX 1,328 1,328 16 21,248 187 3,973,376
Sec. 485.642(b)......................... 0938-XXXX 1,328 1,328 16 21,248 98 2,082,304
Sec. 485.642(c)......................... 0938-XXXX 1,328 120,000 0.083 9,960 94 936,240
Sec. 485.642(c)......................... 0938-XXXX 1,328 30,000 0.033 990 187 185,130
Sec. 485.642(d)......................... 0938-XXXX 1,328 60,000 0.5 30,000 67 2,010,000
Sec. 485.642(d)......................... 0938-XXXX 1,328 60,000 0.083 4,980 141 702,180
Sec. 485.642(e)......................... 0938-XXXX 1,328 600,000 0.05 30,000 67 2,010,000
-------------------------------------------------------------------------------------------------------------
Total................................. .............. 18,158 85,924,474 ............ 5,366,594 .............. 453,520,660
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: **There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have
removed the associated column from Table 1.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
CMS-3317-P, Fax: (202) 395-6974; or, Email:
[email protected].
IV. Regulatory Impact Analysis
A. Statement of Need
Discharge planning is an important component of successful
transitions from acute care hospitals and PAC settings, as we have
previously discussed. It is universally agreed to be an essential
function of hospitals. The transition may be to a patient's home (with
or without PAC services), skilled nursing facility or nursing home,
long term care hospital, rehabilitation facility, assisted living
center, hospice, or a variety of other settings. The location to which
a patient may be discharged should be based on the patient's clinical
care requirements, available support network, and patient and caregiver
treatment preferences and goals of care.
Although the current hospital discharge planning process meets the
needs of many inpatients released from the acute care setting, some
discharges result in less-than optimal outcomes for patients including
complications and adverse events that lead to hospital readmissions.
Reducing avoidable hospital readmissions and patient complications
presents an opportunity for improving the quality and safety of patient
care, while potentially reducing health care costs. Executive Order
13563 expressly states, in its section on retrospective review, that
``agencies shall consider how best to promote retrospective analysis of
rules that may be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal them in
accordance with what has been learned.''
We believe that the provisions of the IMPACT Act that require
hospitals, CAHs, and PAC providers take into account quality measures
and resource use and other measures to assist patients and their
families during the discharge planning process will encourage patients
and their families to become active participants in the planning of
their transition from the hospital to the PAC setting (or between PAC
settings). This requirement will allow patients and their families'
access to information that will help them to make informed decisions
about their post-acute care, while addressing their goals of care and
treatment preferences. Patients and their families that are well
informed of their choices of high-quality PAC providers may reduce
their chances of being re-hospitalized.
Equally importantly, the necessity of meeting this new legislative
requirement provides an opportunity to meet the requirement for
retrospective review of an important set of regulatory requirements
that have not been systematically reviewed in decades. Finally, recent
findings about health care delivery problems related to
hospitalization, including discharge and readmissions, have indicated
that major problems exist. For example, the Institute of Medicine study
To Err is Human found that failure to properly manage and reconcile
medications is a major problem in hospitals (see summary discussion at
https://iom.nationalacademies.org/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx).
B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and
[[Page 68148]]
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). Section 3(f) of Executive
Order 12866 defines a ``significant regulatory action'' as an action
that is likely to result in a rule: (1) (Having an annual effect on the
economy of $100 million or more in any 1 year, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or state,
local or tribal governments or communities (also referred to as
``economically significant''); (2) creating a serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or (4) raising novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we have prepared a RIA
that, taken together with the ICR section and other sections of the
preamble, presents our best estimates of the effects costs and benefits
of the rulemaking.
The Congressional Review Act, 5 U.S.C. 801 et. seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. HHS will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
This proposed rule would create both one-time and annual costs for
CAHs and HHAs. The financial costs are summarized in the table that
follows. We welcome public comments on all of our burden assumptions
and estimates.
Table 2--Section-by-Section Economic Impact Estimates*
----------------------------------------------------------------------------------------------------------------
Number of
Provider/Supplier Frequency affected Likely ($
entities millions)
----------------------------------------------------------------------------------------------------------------
Hospitals (Sec. 482.43)..................... One-time........................ 4,900 17
Recurring Annually.............. 107
CAHs (Sec. 485.642)......................... One-time........................ 1,328 7
Recurring Annually.............. 6
HHAs (Sec. 484.58).......................... One-time........................ 11,930 34
Recurring Annually.............. 283
-----------------------------------------------------------------
Total Costs in First Full Year............ ................................ .............. 454
----------------------------------------------------------------------------------------------------------------
* This table includes entries only for those proposed reforms that we believe would have a measurable economic
effect; includes estimates from ICRs and RIA sections. All estimates are rounded to the nearest million.
C. Anticipated Effects
1. Effects on Hospitals (Including LTCHs and IRFs), CAHs, and HHAs
We have accounted for the regulatory impact of these proposed
changes through the analysis of costs contained in the ICR sections
previously mentioned in this proposed rule. We believe these estimates
encompass all additional burden on hospitals, CAHs and HHAs. Any burden
associated with the proposed changes to the CoPs not accounted for in
the ICR sections or in the RIA section was omitted because we believe
it would constitute a usual and customary business practice and would
not be subject to the PRA in accordance with 5 CFR 1320.3(b)(2). Nor
would it constitute an added cost for purposes of RIA estimates if we
added a regulatory requirement that reflected existing practices and
workload. We note that we do not estimate costs for the newly added
requirement to present quality and cost information to those hospital
patients who face a decision on selection of post-discharge providers.
In our view, hospitals already counsel patients on these choices, and
the availability of written quality information will not add
significantly to the time involved, and may in some cases reduce it
(the information, of course, would only be presented as pertinent to
the particular decisions facing particular patients). Indeed, all
providers affected by this rule already have access to quality
information from the CMS Web sites Hospital Compare, Nursing Home
Compare, and Home Health Compare, as well as other public and private
Web sites and their own knowledge of local providers, and presumably
many or most use this information as appropriate to counsel patients.
If readers believe we have omitted some category of cost by incorrectly
assuming it is already being performed, or to have unnecessarily
presented cost estimates for functions that are already being
performed, we would welcome comments on these areas of the proposed
rule.
Our estimates of the effects of this regulation are subject to
significant uncertainty. While the Department of Health and Human
Services is confident that these proposals will provide flexibilities
to facilities that will minimize cost increases, there are
uncertainties about the magnitude of the discussed effects. However, we
have based our overall assumptions and best estimates on our ongoing
experiences with hospitals, CAHs, and HHAs in these matters. We welcome
public comments on these assumptions and estimates.
In addition, as we previously explained, there may be significant
additional health benefits, such as the reduction in patient
readmissions after discharges and the reduction of other post-discharge
patient complications.
2. Effects on Small Entities
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that the
great majority of the providers that would be affected by our
[[Page 68149]]
rules are small entities as that term is used in the RFA. The great
majority of hospitals and most other healthcare providers and suppliers
are small entities, either by being nonprofit organizations or by
meeting the SBA definition of a small business. Accordingly, the usual
practice of HHS is to treat all providers and suppliers as small
entities in analyzing the effects of our rules.
As shown in table 1, we estimate that the recurring costs of this
proposed rule would cost affected entities approximately $396 million a
year (out of the total first year cost of $454 million a year). A
majority of these costs would impact HHAs. While this is a large amount
in total, the average annual costs per affected HHA are only about
$24,000 per year ($283 million in total for all HHAs/11,930 HHAs).
Although the overall magnitude of the paperwork, staffing, and related
costs to HHAs under this rule is economically significant, these costs
are about 1 percent of total HHA costs. According to the 2014 Annual
Report of the Medicare trustees, the total annual spending on HHA
services from Medicare Parts A and B, not including private payments,
was $18.4 billion in 2013. Our estimated annual cost is 1.5 percent of
that total ($283 million/$l8.4 billion), and as a per patient cost
would be approximately that same percentage (less, if private spending
were included) for all HHAs. Accordingly, we have concluded that the
costs of this proposed rule will not reach 3 percent of revenues, the
threshold used by HHS to determine whether a proposed rule is likely to
create a negative ``significant impact on a substantial number of small
entities,'' and thereby trigger the requirement for an initial
Regulatory Flexibility Analysis.
Effects on hospitals are far smaller, and estimated to be about
$107 million annually in recurring costs. Total annual expenses for all
hospitals are about $859 billion a year.\9\ The estimated costs of this
rule would be approximately one hundredth of one percent of this
expenditure amount and, since revenues and costs are roughly equal, an
equally small percent of revenues.
---------------------------------------------------------------------------
\9\ http://www.aha.org/research/rc/stat-studies/fast-facts.shtml
---------------------------------------------------------------------------
Total national CAH revenues from Medicare are approximately $9
billion a year, or an average of about $7 million annually per hospital
($9 billion/1,328). We believe that all or almost all CAHs meet the
size threshold for small entities. We estimate that this proposed rule
would impose costs of approximately $6 million nationally, or about
$4,600 per hospital (revenue data from MEDPAC report ``Critical Access
Hospitals Payment System'' at http://www.medpac.gov/documents/payment-basics/critical-access-hospitals-payment-system-14.pdf?sfvrsn=0).
Assuming conservatively that one-half of all CAH patients are Medicare
beneficiaries, and that Medicare accounts for a like percentage of
revenues, this would be a small fraction of 1 percent of annual
revenues (or, as is roughly equivalent, annual costs). The HHS
threshold used for determining significant economic effect on small
entities is 3 percent of costs. Accordingly, after a review of cost
effects on HHAs, hospitals, and CAHs, we have determined that this
proposed rule would not have a significant economic impact on a
substantial number of small entities, and certify that an initial RFA
is not required.
We note that quite apart from the gross costs of compliance being a
small fraction of revenues or costs of affected entities, net costs
will be far smaller. Payment for hospital inpatient services for
Medicare beneficiaries is paid primarily according to Medicare severity
diagnosis-related groups (MS-DRGs), and MS-DRGs for hospital procedures
are periodically revised to reflect the latest estimates of costs from
hospitals themselves, as well as from other sources. Hence, absent
offsetting effects from other payment changes, and depending on
hospitals' success in controlling overall costs, some portion of these
costs will be recovered from Medicare. Moreover, hospitals can and do
periodically revise their charges to private insurance carriers
(subject in part to negotiations over rates) and for the approximately
half of all patients who are ``private pay'' cost increases can be
partially offset in that way. As for CAHs, they are largely paid on a
cost basis for their Medicare patients, and will presumably be able to
recoup additional costs through periodic adjustments to public and
private payment rates. Finally, HHAs also obtain periodic changes in
payment rates from both public and private payers. In all three cases,
we have no way to predict precise future pathways or exact timing
however, we believe that most of the recurring costs (and almost all in
the case of CAHs) will be recovered through payments from third party
payers, public and private.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. For the preceding
reasons, we have determined that this proposed rule does not have a
significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2015, that
is approximately $157 million. This proposed rule would require HHA
spending in excess of that threshold, at least in early years before
subsequent payment rate increases may take increased costs into
account. Mandated spending for CAHs, in contrast, is largely reimbursed
on a cost basis and would not count as an unfunded mandate. This RIA
and the preamble as presented together here in this proposed rule meet
the UMRA requirements for analysis.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that would impose substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. This rule would not have a substantial direct effect on
state or local governments, preempt states, or otherwise have a
Federalism implication.
3. Effects on Patients and Medical Care Costs
Patients in all three settings are the major beneficiaries of this
rule. Research cited earlier in this preamble strongly suggests that
there would be reductions in morbidity and mortality from improving
services to these patients through improved discharge planning. We are
unable to quantify either the volume or dollar value of expected
benefits. We are not aware of reliable empirical data on the benefits
of improved discharge planning. In addition, there are multiple
initiatives affecting the same patients (for example, the Hospital
Readmissions Reduction Program, the Medicare EHR Incentive Program, and
the Accountable Care Organizations under the Medicare Shared Savings
Program). This makes it challenging to sort out the separable benefits
of this proposed rule.
[[Page 68150]]
Nonetheless, the number of patients potentially benefitting is
significant. There are roughly 35 million inpatient discharges from
hospitals annually. In addition, there are approximately 32 million
patients newly affected by substantially modified discharge planning
requirements (this figure includes an additional 13 million annual
hospital outpatient discharges, 18 million annual HHA patient
discharges, and 600,000 annual CAH discharges). If mortality or serious
morbidity were prevented for even a fraction of 1 percent of these
nearly 50 million patients, potentially tens or hundreds of thousands
of persons would substantially benefit.
There are existing requirements in place for discharge planning and
for reducing adverse events such as hospital readmissions, both in
regulations governing patient care and in payment regulations, but
little or no data on the effectiveness of these requirements compared
to the normal effects of good medical practice. The changes that would
be implemented by this proposed rule are an additional overlay on top
of existing practices and requirements. It is challenging to
disentangle all these overlapping factors. Therefore, existing data
demonstrate that even small improvements can have effects as large as
those previously suggested in this proposed rule. For example, one
meta-analysis showed that transitional care that promotes the safe and
timely transfer of patients from hospital to home has been proven to be
highly effective in reducing readmissions.\10\ We welcome comments that
would provide evidence in regard to these findings.
---------------------------------------------------------------------------
\10\ Kim J. Verhhaegh et al., ``Transitional Care Interventions
Prevent Hospital Readmissions for Adults with Chronic Illnesses,''
Health Affairs, 33, no. 9 (2014):1531-1539.
---------------------------------------------------------------------------
D. Alternatives Considered
As we previously stated in this proposed rule, some of these
provisions are mandated under the IMPACT Act, therefore, no major
alternatives were considered. For the other proposed provisions, we
considered not making these changes. We did not consider additional
requirements that we did not believe would result in substantial
benefits at reasonable cost. For example, we considered requiring
specific post-discharge follow-up procedures, but concluded that the
range of procedures is so great (including, for example, such very low
cost procedures as automatically generated text or email reminders
about medication compliance, and such high cost procedures as home
visits by nurses), and the range of patient situations so wide
(including in many cases no likely benefit from follow-up and in others
no efficient way to predict likely benefits), that no reasonable or
practicable requirement could be devised at this time. Of course, we
encourage providers to use follow-up procedures they find cost-
effective for particular categories of patients. We welcome comments
and data on these or other follow-up alternatives that may have been
shown to be cost-effective in discharge planning, and on what form and
with what enforcement standards a mandatory requirement might
reasonably use.
We also considered proposing mandatory use of the approximately 50
state-run PDMPs by providers regulated under this proposed rule (each
state has its own version and operational, security, access, and other
details vary by state). Where hospitals in particular states
voluntarily use such programs based on their own determination of
utility, we strongly encourage use of such systems. PDMPs have proven
useful for law enforcement purposes and, in some states, for pharmacy
use. There are, however, uncertainties as to use in hospital settings.
As one recent study stated, ``whether mandates should become a best
practice depends on proving their [PDMP] feasibility and benefits.''
\11\ As discussed earlier in the preamble, there are also questions
about ``legal, technical, privacy, or security challenges'' of provider
use of PDMPs, including difficulties of use with EHRs.\12\ Regardless,
we need current information on whether and where PDMPs have been used
effectively and at reasonable cost in hospital discharge planning.\13\
Accordingly, we solicit comments that provide specific information on
the feasibility, costs, and patient benefits of using PDMP systems in
hospital discharge planning, and on workable implementation and
enforcement standards for a possible mandatory requirement.
---------------------------------------------------------------------------
\11\ Thomas Clark, John Eadie, Peter Kreiner, and Gail
Strickler. Prescription Drug Monitoring Programs: An Assessment of
the Evidence for Best Practices. A study prepared for the PEW
Charitable Trusts. September 20, 2012. At: http://www.pdmpexcellence.org/sites/all/pdfs/Brandeis_PDMP_Report_final.pdf.
\12\ HHS report to the Congress, Prescription Drug Monitoring
Program Interoperability Standards, September 2013, section on
``Assessment of Legal, Technical, Fiscal, Privacy, and Security
Challenges,'' at https://www.healthit.gov/sites/default/files/fdasia1141report_final.pdf.
\13\ See the case studies in the 2013 report Connecting for
Impact: Integrating Health IT and PDMPs to Improve Patient Care, The
Mitre Corporation, at https://www.healthit.gov/sites/default/files/connecting_for_impact-final-508.pdf. https://www.healthit.gov/sites/default/files/connecting_for_impact-final-508.pdf.
---------------------------------------------------------------------------
For all provisions, we attempted to minimize unnecessarily
prescriptive methods or procedures, and to avoid any unnecessarily
costly requirements. We welcome comments on whether we properly
selected the best provisions for change and on whether there are
alternatives or improvements to the proposed provisions that would
increase benefits at reasonable cost or reduce costs without
compromising important benefits.
E. Cost to the Federal Government
If these requirements are finalized, CMS will update the
interpretive guidance, update the survey process, and provide training.
In order to implement these new standards, we anticipate initial
federal startup costs between $8 to $10 million. The continuing costs
(survey process-recertifications, enforcement, appeals, AO) are
estimated $4,461,131 and will continue annually, thereafter. CMS will
continue to examine and seeks comment on the potential impacts to both
Medicare and Medicaid.
F. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars_a004_a-4), in Table 2 we present an
accounting statement showing the classification of the costs and
benefits associated with the provisions of this final rule. The
accounting statement is based on estimates provided in this regulatory
impact analysis. We have used as an estimating horizon a 5 year period,
but expect that annualized costs would remain essentially the same over
a longer period, after the initial year. For purposes of this table, we
have used a low estimate that is 25 percent lower than our primary
estimate, and a high estimate that is 25 percent higher than our
primary estimate. As previously discussed, we have no empirical data or
results from previous studies that would allow a defensible estimate of
annualized benefits in terms of morbidity and mortality prevented, and
medical costs avoided.
[[Page 68151]]
Table 2--Accounting Statement: Classification of Estimated Costs and Benefits
[$ In millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary -----------------------------------------------
Category estimate Low estimate High estimate Discount rate
Year dollars (%) Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits--Qualitative not quantitative or monetized..... Potential Reductions in morbidity, mortality, and medical costs for hospital, HHA, and CAH
patients.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs--Annual Monetized Costs of Discharge Planning to $420 $310 $510 2015 7 2016-20
Medical Care Providers.................................
410 310 510 2015 3 2016-20
-----------------------------------------------------------------------------------------------
Transfers............................................... None.
--------------------------------------------------------------------------------------------------------------------------------------------------------
This proposed rule was reviewed by the Office of Management and
Budget.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
List of Subjects
42 CFR Part 482
Grant Programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
42 CFR Part 484
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 485
Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
and Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
1. The authority citation for part 482 is revised to read as follows:
Authority: Secs. 1102, 1871, 1881, 1899B of the Social Security
Act (42 U.S.C. 1302, 1395hh, 1395rr, and 1395lll) unless otherwise
noted.
0
2. Section 482.43 is revised to read as follows:
Sec. 482.43 Condition of participation: Discharge planning.
The hospital must develop and implement an effective discharge
planning process that focuses on the patient's goals and preferences
and prepares patients and their caregivers/support person(s), to be
active partners in post-discharge care, planning for post-discharge
care that is consistent with the patient's goals for care and treatment
preferences, effective transition of the patient from hospital to post-
discharge care, and the reduction of factors leading to preventable
hospital readmissions.
(a) Standard: Design. The discharge planning process policies and
procedures must meet the following requirements:
(1) Be developed with input from the hospital's medical staff,
nursing leadership as well as other relevant departments;
(2) Be reviewed and approved by the governing body; and
(3) Be specified in writing.
(b) Standard: Applicability. The discharge planning process must
apply to:
(1) All inpatients;
(2) Outpatients receiving observation services;
(3) Outpatients undergoing surgery or other same day procedures for
which anesthesia or moderate sedation are used;
(4) Emergency department patients identified in accordance with the
hospital's discharge planning policies and procedures by the emergency
department practitioner responsible for the care of the patient as
needing a discharge plan; and
(5) Any other category of outpatients as recommended by the medical
staff and specified in the hospital's discharge planning policies and
procedures approved by the governing body.
(c) Standard: Discharge planning process. The hospital's discharge
planning process must ensure that the discharge goals, preferences, and
needs of each patient are identified and result in the development of a
discharge plan for each patient in accordance with paragraph (b) of
this section.
(1) A registered nurse, social worker, or other personnel qualified
in accordance with the hospital's discharge planning policies must
coordinate the discharge needs evaluation and development of the
discharge plan.
(2) The hospital must begin to identify the anticipated discharge
needs for each applicable patient within 24 hours after admission or
registration, and the discharge planning process is completed prior to
discharge home or transfer to another facility and without unduly
delaying the patient's discharge or transfer. If the patient's stay is
less than 24 hours, the discharge needs for each applicable patient
must be identified and the discharge planning process completed prior
to discharge home or transfer to another facility and without
unnecessarily delaying the patient's discharge or transfer.
(3) The hospital's discharge planning process must require regular
re-evaluation of the patient's condition to identify changes that
require modification of the discharge plan. The discharge plan must be
updated, as needed, to reflect these changes.
(4) The practitioner responsible for the care of the patient must
be involved in the ongoing process of establishing the patient's goals
of care and treatment preferences that inform the discharge plan.
(5) The hospital must consider caregiver/support person and
community based care availability and the patient's or caregiver's/
support person's capability to perform required care including self-
care, care from a support person(s), follow-up care from a community
based provider, care from post-acute care practitioners and facilities,
or, in the case of a patient
[[Page 68152]]
admitted from a long term care facility or other residential facility,
care in that setting, as part of the identification of discharge needs.
The hospital must consider the following in evaluating a patient's
discharge needs, including but not limited to:
(i) Admitting diagnosis or reason for registration;
(ii) Relevant co-morbidities and past medical and surgical history;
(iii) Anticipated ongoing care needs post-discharge;
(iv) Readmission risk;
(v) Relevant psychosocial history;
(vi) Communication needs, including language barriers, diminished
eyesight and hearing, and self-reported literacy of the patient,
patient's representative or caregiver/support person(s), as applicable;
(vii) Patient's access to non-health care services and community
based care providers; and
(viii) Patient's goals and treatment preferences.
(6) The patient and caregiver/support person(s) must be involved in
the development of the discharge plan, and informed of the final plan
to prepare them for post-hospital care.
(7) The discharge plan must address the patient's goals of care and
treatment preferences.
(8) The hospital must assist the patients, their families, or the
patient's representative in selecting a post-acute care provider by
using and sharing data that includes but is not limited to HHA, SNF,
IRF, or LTCH data on quality measures and data on resource use
measures. The hospital must ensure that the post-acute care data on
quality measures and data on resource use measures is relevant and
applicable to the patient's goals of care and treatment preferences.
(9) The evaluation of the patient's discharge needs and the
resulting discharge plan must be documented and completed on a timely
basis, based on the patient's goals, preferences, strengths, and needs,
so that appropriate arrangements for post-hospital care are made before
discharge to avoid unnecessary delays in discharge.
(i) The discharge plan must be included in the patient's medical
record. The results of the evaluation must be discussed with the
patient or patient's representative.
(ii) All relevant patient information must be incorporated into the
discharge plan to facilitate its implementation and to avoid
unnecessary delays in the patient's discharge or transfer.
(10) The hospital must assess its discharge planning process on a
regular basis. The assessment must include ongoing, periodic review of
a representative sample of discharge plans, including those patients
who were readmitted within 30 days of a previous admission, to ensure
that the plans are responsive to patient post-discharge needs.
(d) Standard: Discharge to home. (1) Discharge instructions must be
provided at the time of discharge to:
(i) The patient and/or the patient's caregiver/support person(s),
and
(ii) The post-acute care provider or supplier, if the patient is
referred to post-acute care services.
(2) The discharge instructions must include, but are not limited
to, the following:
(i) Instruction on post-hospital care to be used by the patient or
the caregiver/support person(s) in the patient's home, as identified in
the discharge plan;
(ii) Written information on warning signs and symptoms that may
indicate the need to seek immediate medical attention. This must
include written instructions on what the patient or the caregiver/
support person(s) should do and who they should contact if these
warning signs or symptoms present;
(iii) Prescriptions and over-the counter medications that are
required after discharge, including the name, indication, and dosage of
each drug, along with any significant risks and side effects of each
drug as appropriate to the patient;
(iv) Reconciliation of all discharge medications with the patient's
pre-hospital admission/registration medications (both prescribed and
over-the-counter); and
(v) Written instructions in paper and/or electronic format
regarding the patient's follow-up care, appointments, pending and/or
planned diagnostic tests, and pertinent contact information, including
telephone numbers, for any practitioners involved in follow-up care or
for any providers/suppliers to whom the patient has been referred for
follow-up care.
(3) The hospital must send the following information to the
practitioner(s) responsible for follow up care, if the practitioner is
known and has been clearly identified:
(i) A copy of the discharge instructions and the discharge summary
within 48 hours of the patient's discharge;
(ii) Pending test results within 24 hours of their availability;
(iii) All other necessary information as specified in Sec.
482.43(e)(2).
(4) The hospital must establish a post-discharge follow-up process.
(e) Standard: Transfer of patients to another health care facility.
(1) The hospital must send necessary medical information to the
receiving facility at the time of transfer.
(2) Necessary medical information must include:
(i) Demographic information, including but not limited to name,
sex, date of birth, race, ethnicity, preferred language;
(ii) Contact information for the practitioner responsible for the
care of the patient, as described at paragraph (b)(4) of this section,
and the patient's caregiver(s)/support person(s), if applicable;
(iii) Advance directive, if applicable;
(iv) Course of illness/treatment;
(v) Procedures;
(vi) Diagnoses;
(vii) Laboratory tests and the results of pertinent laboratory and
other diagnostic testing;
(viii) Consultation results;
(ix) Functional status assessment;
(x) Psychosocial assessment, including cognitive status;
(xi) Social supports;
(xii) Behavioral health issues;
(xiii) Reconciliation of all discharge medications with the
patient's pre-hospital admission/registration medications (both
prescribed and over-the counter);
(xiv) All known allergies, including medication allergies;
(xv) Immunizations;
(xvi) Smoking status;
(xvii) Vital signs;
(xviii) Unique device identifier(s) for a patient's implantable
device(s), if any;
(xix) All special instructions or precautions for ongoing care, as
appropriate;
(xx) Patient's goals and treatment preferences; and
(xxi) All other necessary information including a copy of the
patient's discharge instructions, the discharge summary and any other
documentation as applicable, to ensure a safe and effective transition
of care that supports the post-discharge goals for the patient.
(f) Standard: Requirements for post-acute care services. For those
patients discharged home and referred for HHA services, or for those
patients transferred to a SNF for post-hospital extended care services,
or transferred to an IRF or LTCH for specialized hospital services, the
following requirements apply, in addition to those set out at
paragraphs (a) through (d) of this section:
(1) The hospital must include in the discharge plan a list of HHAs,
SNFs, IRFs, or LTCHs that are available to the patient, that are
participating in the Medicare program, and that serve the geographic
area (as defined by the HHA) in which the patient resides, or in the
[[Page 68153]]
case of a SNF, IRF, or LTCH, in the geographic area requested by the
patient. HHAs must request to be listed by the hospital as available.
(i) This list must only be presented to patients for whom home
health care post-hospital extended care services, SNF, IRF, or LTCH
services are indicated and appropriate as determined by the discharge
planning evaluation.
(ii) For patients enrolled in managed care organizations, the
hospital must make the patient aware of the need to verify with their
managed care organization which practitioners, providers or certified
suppliers are in the managed care organization's network. If the
hospital has information on which practitioners, providers or certified
supplies are in the network of the patient's managed care organization,
it must share this with the patient or the patient's representative.
(iii) The hospital must document in the patient's medical record
that the list was presented to the patient or to the patient's
representative.
(2) The hospital, as part of the discharge planning process, must
inform the patient or the patient's representative of their freedom to
choose among participating Medicare providers and suppliers of post-
discharge services and must, when possible, respect the patient's or
the patient's representative's goals of care and treatment preferences,
as well as other preferences they express. The hospital must not
specify or otherwise limit the qualified providers or suppliers that
are available to the patient.
(3) The discharge plan must identify any HHA or SNF to which the
patient is referred in which the hospital has a disclosable financial
interest, as specified by the Secretary, and any HHA or SNF that has a
disclosable financial interest in a hospital under Medicare. Financial
interests that are disclosable under Medicare are determined in
accordance with the provisions of part 420, subpart C, of this chapter.
PART 484--HOME HEALTH SERVICES
0
3. The authority citation for part 484 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)), unless otherwise indicated.
0
4. Section 484.58 is added to subpart C to read as follows:
Sec. 484.58 Condition of participation: Discharge Planning.
A Home Health Agency (HHA) must develop and implement an effective
discharge planning process that focuses on preparing patients to be
active partners in post-discharge care, effective transition of the
patient from HHA to post-HHA care, and the reduction of factors leading
to preventable readmissions.
(a) Standard: Discharge planning process. The HHA's discharge
planning process must ensure that the discharge goals, preferences, and
needs of each patient are identified and result in the development of a
discharge plan for each patient.
(1) The discharge planning process must require regular re-
evaluation of patients to identify changes that require modification of
the discharge plan, in accordance with the provisions for updating the
patient assessment at Sec. 484.55. The discharge plan must be updated,
as needed, to reflect these changes.
(2) The physician responsible for the home health plan of care must
be involved in the ongoing process of establishing the discharge plan.
(3) The HHA must consider caregiver/support person availability,
and the patient's or caregiver's capability to perform required care,
as part of the identification of discharge needs.
(4) The patient and caregiver(s) must be involved in the
development of the discharge plan, and informed of the final plan.
(5) The discharge plan must address the patient's goals of care and
treatment preferences.
(6) For patients who are transferred to another HHA or who are
discharged to a SNF, IRF, or LTCH, the HHA must assist patients and
their caregivers in selecting a post-acute care provider by using and
sharing data that includes, but is not limited to HHA, SNF, IRF, or
LTCH data on quality measures and data on resource use measures. The
HHA must ensure that the post-acute care data on quality measures and
data on resource use measures is relevant and applicable to the
patient's goals of care and treatment preferences.
(7) The evaluation of the patient's discharge needs and discharge
plan must be documented and completed on a timely basis, based on the
patient's goals, preferences, and needs. The discharge plan must be
included in the clinical record. The results of the evaluation must be
discussed with the patient or patient's representative. All relevant
patient information must be incorporated into the discharge plan to
facilitate its implementation and to avoid unnecessary delays in the
patient's discharge or transfer.
(b) Standard: Discharge or transfer summary content. The HHA must
send necessary medical information to the receiving facility or health
care practitioner. Necessary medical information must include:
(1) Demographic information, including but not limited to name,
sex, date of birth, race, ethnicity, preferred language;
(2) Contact information for the physician responsible for the home
health plan of care;
(3) Advance directive, if applicable;
(4) Course of illness/treatment;
(5) Procedures;
(6) Diagnoses;
(7) Laboratory tests and the results of pertinent laboratory and
other diagnostic testing;
(8) Consultation results;
(9) Functional status assessment;
(10) Psychosocial assessment, including cognitive status;
(11) Social supports;
(12) Behavioral health issues;
(13) Reconciliation of all discharge medications (both prescribed
and over-the-counter);
(14) All known allergies, including medication allergies;
(15) Immunizations;
(16) Smoking status;
(17) Vital Signs;
(18) Unique device identifier(s) for a patient's implantable
device(s), if any;
(19) Recommendations, instructions, or precautions for ongoing
care, as appropriate;
(20) Patient's goals of care and treatment preferences;
(21) The patient's current plan of care, including goals,
instructions, and the latest physician orders; and
(22) Any other information necessary to ensure a safe and effective
transition of care that supports the post-discharge goals for the
patient.
PART 485--CONDITIONS OF PARTICIPATION SPECIALIZED PROVIDERS
0
5. The authority citation for part 485 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).
0
6. Section 485.635 is amended by adding paragraph (a)(3)(viii) to read
as follows:
Sec. 485.635 Condition of participation: Provision of services.
* * * * *
(a) * * *
(3) * * *
(viii) Discharge planning policies and procedures, in accordance
with the requirements of Sec. 485.642.
* * * * *
[[Page 68154]]
0
7. Section 485.642 is added to read as follows:
Sec. 485.642 Condition of participation: Discharge planning.
A Critical Access Hospital (CAH) must develop and implement an
effective discharge planning process that focuses on preparing patients
to participate in post-discharge care, planning for post-discharge care
that is consistent with the patient's goals for care and treatment
preferences, effective transition of the patient from the CAH to post-
discharge care, and the reduction of factors leading to preventable
readmissions to a CAH or a hospital.
(a) Standard: Design. The discharge planning process policies and
procedures must meet the following requirements:
(1) Be developed with input from the CAH's professional healthcare
staff, nursing leadership as well as other relevant departments;
(2) Be reviewed and approved by the governing body or responsible
individual; and
(3) Be specified in writing.
(b) Standard: Applicability. The discharge planning process must
apply to:
(1) All inpatients;
(2) Outpatients receiving observation services;
(3) Outpatients undergoing surgery or other same day procedures for
which anesthesia or moderate sedation are used;
(4) Emergency department patients identified in accordance with the
CAH's discharge planning policies and procedures by the emergency
department practitioner responsible for the care of the patient as
needing a discharge plan; and
(5) Any other category of outpatients as recommended by the medical
staff and specified in the CAH's discharge planning policies and
procedures approved by the governing body or responsible individual.
(c) Standard: Discharge planning process. The CAH's discharge
planning process must ensure that the discharge goals, preferences, and
needs of each patient are identified and result in the development of a
discharge plan for each patient in accordance with paragraph (a) of
this section.
(1) A registered nurse, social worker, or other personnel qualified
in accordance with the CAH's discharge planning policies must
coordinate the discharge needs evaluation and development of the
discharge plan.
(2) The CAH must begin to identify the anticipated goals,
preferences, and discharge needs for each applicable patient within 24
hours after admission or registration and the discharge planning
process is completed prior to discharge home or transfer to another
facility and without unduly delaying the patient's discharge or
transfer. If the patient's stay is less than 24 hours, the discharge
needs for each applicable patient must be identified and the discharge
planning process completed prior to discharge home or transfer to
another facility and without unnecessarily delaying the patient's
discharge or transfer.
(3) The CAH's discharge planning process must require regular re-
evaluation of patients to identify changes that require modification of
the discharge plan. The discharge plan must be updated, as needed, to
reflect these changes.
(4) The practitioner responsible for the care of the patient must
be involved in the ongoing process of establishing the patient's goals
of care and treatment preferences that inform the discharge plan.
(5) The CAH must consider caregiver/support person and community
based care availability, and the patient's or caregiver's/support
person's capability to perform required care including self-care, care
from a support person(s), follow-up care from a community based
provider, care from post-acute care facilities, or, in the case of a
patient admitted from a long term care or other residential facility,
care in that setting, as part of the identification of discharge needs.
The CAH must consider the following in evaluating a patient's discharge
needs, including but not limited to:
(i) Admitting diagnosis or reason for registration;
(ii) Relevant co-morbidities and past medical and surgical history;
(iii) Anticipated ongoing care needs post-discharge;
(iv) Readmission risk;
(v) Relevant psychosocial history;
(vi) Communication needs, including language barriers, diminished
eyesight and hearing, and self-reported literacy of the patient,
patient's representative or caregiver/support person(s), as applicable;
(vii) Patient's access to non-health care services and community
based providers; and
(viii) Patient's goals and preferences.
(6) The patient and caregiver/support person(s) must be involved in
the development of the discharge plan and informed of the final plan to
prepare them for post-CAH care.
(7) The discharge plan must address the patient's goals of care and
treatment preferences.
(8) The CAH must assist patients, their families, or their
caregivers/support persons in selecting a post-acute care provider by
using and sharing data that includes but is not limited to HHA, SNF,
IRF, or LTCH data on quality measures and data on resource use
measures. The CAH must ensure that the post-acute care data on quality
measures and data on resource use measures furnished to the patient is
specific to the post-acute care setting(s) and relevant and applicable
to the patient's goals of care and treatment preferences.
(9) The evaluation of the patient's discharge needs and the
resulting discharge plan must be documented and completed on a timely
basis, based on the patient's goals, preferences, strengths, and needs,
so that appropriate arrangements for post-CAH care are made before
discharge to avoid unnecessary delays in discharge.
(i) The discharge plan must be included in the patient's medical
record. The results of the evaluation must be discussed with the
patient or patient's representative.
(ii) All relevant patient information must be incorporated into the
discharge plan to facilitate its implementation and to avoid
unnecessary delays in the patient's discharge or transfer.
(10) The CAH must assess its discharge planning process in
accordance with the requirements of Sec. 485.635(a)(4). The assessment
must include ongoing, periodic review of a representative sample of
discharge plans, including those patients who were readmitted within 30
days of a previous admission to ensure that the plans are responsive to
patient post-discharge needs.
(d) Standard: Discharge to home. (1) Discharge instructions must be
provided at the time of discharge to:
(i) The patient and/or the patient's caregiver/support person(s),
and
(ii) The post-acute care service provider or supplier, if the
patient is referred to community-based services.
(2) The discharge instructions must include, but are not limited
to, the following:
(i) Instruction on post-discharge care to be used by the patient or
the caregiver/support person(s) in the patient's home, as identified in
the discharge plan;
(ii) Written information on warning signs and symptoms that may
indicate the need to seek immediate medical attention. This must
include written instructions on what the patient or the
[[Page 68155]]
caregiver/support person(s) should do and who they should contact if
these warning signs or symptoms present;
(iii) Prescriptions for medications that are required after
discharge, including a list of name, indication, and dosage of each
drug, along with any significant risks and side effects of each drug as
appropriate to the patient;
(iv) Reconciliation of all discharge medications with the patient's
pre-CAH admission/registration medications (both prescribed and over-
the-counter); and
(v) Written instructions regarding the patient's follow-up care,
appointments, pending and/or planned diagnostic tests, and pertinent
contact information, including telephone numbers, for practitioners
involved in follow-up care or for any providers/suppliers to whom the
patient has been referred for follow-up care.
(3) The CAH must send the following information to the
practitioner(s) responsible for follow up care, if the practitioner is
known and has been clearly identified:
(i) A copy of the discharge instructions and the discharge summary
within 48 hours of the patient's discharge;
(ii) Pending test results within 24 hours of their availability;
(iii) All other necessary medical information as specified in Sec.
485.642(e)(2).
(4) The CAH must establish a post-discharge follow-up process.
(e) Standard: Transfer of patients to another health care facility.
(1) The CAH must send necessary medical information to the receiving
facility at the time of transfer.
(2) Necessary medical information includes:
(i) Demographic information, including but not limited to name,
sex, date of birth, race, ethnicity, preferred language;
(ii) Contact information for the practitioner responsible for the
care of the patient, as described at paragraph (b)(4) of this section,
and the patient's caregiver/support person(s), if applicable;
(iii) Advance directive, if applicable;
(iv) Course of illness/treatment;
(v) Procedures;
(vi) Diagnoses;
(vii) Laboratory tests and the results of pertinent laboratory and
other diagnostic testing;
(viii) Consultation results;
(ix) Functional status assessment;
(x) Psychosocial assessment, including cognitive status;
(xi) Social supports;
(xii) Behavioral health issues;
(xiii) Reconciliation of all discharge medications with the
patient's pre-CAH admission/registration medications (both prescribed
and over-the-counter);
(xiv) All known allergies, including medication allergies;
(xv) Immunizations;
(xvi) Smoking status;
(xvii) Vital signs;
(xviii) Unique device identifier(s) for a patient's implantable
device(s), if any;
(xix) All special instructions or precautions for ongoing care, as
appropriate;
(xx) Patient's goals and treatment preferences; and
(xxi) Any other necessary information including a copy of the
patient's discharge instructions, the discharge summary, and any other
documentation as applicable, to ensure a safe and effective transition
of care that supports the post-discharge goals for the patient.
Dated: October 19, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: October 22, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-27840 Filed 10-29-15; 8:45 am]
BILLING CODE 4120-01-P
Office of the Federal Register, National Archives and Records Administration
Section
Proposed Rules
Action
Proposed rule.
Dates
To be assured consideration, comments must be received at one of
Contact
Alpha-Banu Huq, (410) 786-8687. Sheila C. Blackstock, (410) 786-1154. Mary Collins, (410) 786-3189. Scott Cooper, (410) 786-9465. Jacqueline Leach, (410) 786-4282. Lisa Parker, (410) 786-4665.
FR Citation
80
FR
68126
RIN Number
0938-AS59
CFR Citation
42
CFR
482 42
CFR
484 42
CFR
485
CFR Associated
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and
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