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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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
Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules 68127

1. Design (Proposed § 482.43(a)) hospital readmissions and patient of patients being discharged, we believe
2. Applicability (Proposed § 482.43(b)) complications presents an opportunity hospitals and CAHs must:
3. Discharge Planning Process (Proposed for improving the quality and safety of • Identify the types of services
§ 482.43(c)) patient care while lowering health care needed upon discharge, including
4. Discharge to Home (Proposed
costs. options for tele-behavioral health
§ 482.43(d))
5. Transfer of Patients to Another Health Patients’ post-discharge needs are services as available and appropriate;
Care Facility (Proposed § 482.43(e)) frequently complicated and multi- • Identify organizations offering
6. Requirements For Post-Acute Care factorial, requiring a significant level of community services in the psychiatric
Services (Proposed § 482.43(f)) on-going planning, coordination, and hospital or unit’s community, and
B. Home Health Agency Discharge communication among the health care demonstrate efforts to establish
Planning practitioners and facilities currently partnerships with such organizations;
1. Discharge Planning Process (Proposed caring for a patient and those who will arrange, as applicable, for the
§ 484.58(a)) provide post-acute care for the patient, development and implementation of a
2. Discharge or Transfer Summary Content specific psychiatric discharge plan for
(Proposed § 484.58(b))
including the patient and his or her
C. Critical Access Hospital Discharge caregivers. The discharge planning the patient as part of the patient’s
Planning process should ensure that patients and, overall discharge plan; and
1. Design (Proposed § 485.642(a)) when applicable, their caregivers, are • Coordinate with the patient for
2. Applicability (Proposed § 485.642(b)) properly prepared to be active partners referral for post-acute psychiatric or
3. Discharge Planning Process (Proposed and advocates for their healthcare and behavioral health care, including
§ 485.642(c)) community support needs upon transmitting pertinent information to
4. Discharge to Home (Proposed discharge from the hospital or PAC the receiving organization as well as
§ 485.642(d)(1) through (3)) setting. Yet patients and their caregivers making recommendations about the
5. Transfer of Patients To Another Health post-acute psychiatric or behavioral
Care Facility (Proposed § 485.642(e))
frequently are not meaningfully
involved in the discharge planning health care needed by the patient.
III. Collection of Information Requirements
A. ICRs Regarding Hospital Discharge process and are unable to name their We have also found that not having a
Planning (§ 482.43) diagnoses; list their medications, their thorough understanding of available
B. ICRs Regarding Home Health Discharge purpose, or the major side effects; community services can impact the
Planning (§ 484.58) cannot explain their follow-up plan of discharge planning process. If the
C. ICRs Regarding Critical Access Hospital care; or articulate their treatment discharge planning team and patients or
Discharge Planning (§ 485.642) preferences and goals of care. For their caregivers are not aware of the full
IV. Regulatory Impact Analysis patients who require PAC services, the range of post-hospital services available,
A. Statement of Need including non-medical services and
B. Overall Impact
discharge planning process should
ensure that the transition from one care supports, patients may be sent to care
C. Anticipated Effects
1. Effects on Hospitals (including LTCHs setting to another (for example, from a settings that are inappropriate,
and IRFs), CAHs, and HHAs hospital to a skilled nursing facility or ineffective, or of inadequate quality. The
2. Effects on Small Entities to home with help from a home health lack of consistent collaboration and
3. Effects on Patients and Medical Care agency or community-based services teamwork among health care facilities,
Costs provider (or both) is seamless. The patients, their families, and relevant
D. Alternatives Considered receiving PAC facilities or organizations community organizations may
E. Cost to the Federal Government should have the necessary information negatively impact selection of the best
F. Accounting Statement type of patient placement, leading to
V. Response to Comments
and be prepared to assume
responsibility for the care of the patient. less than ideal patient outcomes and
I. Background When patients or receiving facilities or unnecessary re-hospitalizations. When
organizations do not have key planning transitions, hospitals should
A. Overview consult with Aging and Disability
information such as the information
Discharge planning is an important previously mentioned, they are less able Resource Centers (ADRCs) (as defined in
component of successful transitions to implement the appropriate post- section 102 of the Older Americans Act
from acute care hospitals and post-acute discharge treatment plans. This puts of 1965 (42 U.S.C. 3002)), or Area
care (PAC) settings. The transition may patients at risk for serious complications Agencies on Aging (AAAs) (also defined
be to a patient’s home (with or without and increases their chances of being re- in section 102 of the Older Americans
PAC services), skilled nursing facility, hospitalized. Act of 1965 (42 U.S.C. 3002)) and
nursing home, long term care hospital, We also believe that hospitals and Centers for Independent Living (CILs)
rehabilitation hospital or unit, assisted critical access hospitals (CAHs) should (as defined in section 702 of the
living center, substance abuse treatment improve their focus on psychiatric and Rehabilitation Act of 1973 (29 U.S.C.
program, hospice, or a variety of other behavioral health patients, including 796a)), or Substance Abuse Mental
settings. The location to which a patient patients with substance use disorders. Health Services Administration’s
may be discharged should be based on While the current discharge planning (SAMHSA’s) treatment locator, or any
the patient’s clinical care requirements, requirements as well as those proposed combination of the centers or
available support network, and patient in this rule include this subset of associations. ADRCs, AAAs, and CILs
and caregiver treatment preferences and patients, we believe the special are required by federal statute to help
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goals of care. discharge planning needs of these connect individuals to community
Although the current hospital patients are sometimes overlooked. We services and supports, and many of
discharge planning process meets the encourage hospital and CAHs to take the these organizations already help
needs of many inpatients released from needs of psychiatric and behavioral chronically impaired individuals with
the acute care setting, some discharges health patients into consideration when transitions across settings, including
result in less-than-optimal outcomes for planning discharge and arranging for transitions from hospitals and PAC
patients including complications and PAC and community services. With settings back home. Ongoing
adverse events that lead to hospital these patients specifically, and just as communication with a feedback loop
readmissions. Reducing avoidable we believe it should be with other types among health care practitioners and

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68130 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules

requirements to hospitals on what leadership, and other pertinent services stages of development for a young
actions they must take prior to the provide input in the development of the healthy patient could possibly be as
patient’s discharge or transfer to a PAC discharge planning process. We also concise as a plan to provide instructions
setting would lead to improved propose to require that the discharge on follow-up appointments, and
transitions of care and patient outcomes. planning process be specified in writing information on the warning signs and
We propose to revise the existing and be reviewed and approved by the symptoms which may indicate the need
requirements in the form of six hospital’s governing body. We would to seek medical attention. On the other
standards at § 482.43. The most notable expect that the discharge planning hand, the discharge needs of patients
revision would be to require that all process policies and procedures would with co-morbidities, complex medical
inpatients and specific categories of be developed and reviewed periodically or surgical histories (or both), with
outpatients be evaluated for their by the hospital’s governing body. mental health or substance use
discharge needs and have a written disorders (including indications of
discharge plan developed. Many of the 2. Applicability (Proposed § 482.43(b))
opioid abuse), socio-economic and
current discharge planning concepts We propose to revise the current literacy barriers, and multiple
and requirements would be retained, requirement at § 482.43(a), which medications would require a more
but revised to provide more clarity. We requires a hospital to identify those extensive discharge plan that takes into
also propose to require specific patients for whom a discharge plan is account all of these factors and the
discharge instructions for all patients. necessary. At proposed § 482.43(b), patients treatment preferences and goals
At present, hospitals have some ‘‘Applicability,’’ we would require that of care. As previously discussed, patient
discretion and not every patient receives many types of patients be evaluated for referrals to or consultation with
specific, written instructions. post discharge needs. We would require community care organizations will be a
We have reviewed the available that the discharge planning process key step, for some, in assuring
literature on readmissions and sought to apply to all inpatients, as well as certain successful patient outcomes. Therefore,
understand the various factors that categories of outpatients, including, but we believe that discharge planning for
influence the causes of avoidable not limited to patients receiving patients is a process that involves the
readmissions. We recognize that much observation services, patients who are consideration of the patient’s unique
evidence-based research has been done undergoing surgery or other same-day circumstances, treatment preferences,
to identify interventions that reduce procedures where anesthesia or and goals of care, and not solely a
readmissions of individuals with moderate sedation is used, emergency documentation process.
specific characteristics or conditions department patients who have been We remind hospitals that they must
such as the elderly, cardiac patients, identified by a practitioner as needing a continue to abide by federal civil rights
and patients with chronic conditions. discharge plan, and any other category laws, including Title VI of the Civil
We propose to continue our efforts to of outpatient as recommended by the Rights Act of 1964, the Americans with
reduce patient readmissions by medical staff, approved by the Disabilities Act (ADA), and section 504
improving the discharge planning governing body and specified in the of the Rehabilitation Act of 1973, when
process that would require hospitals to hospital’s discharge planning policies developing a discharge planning
take into account the patient’s goals and and procedures. We believe that the process. To this end, hospitals should
preferences in the development of their aforementioned categories of patients take reasonable steps to provide
plans and to better prepare patients and would benefit from an evaluation of individuals with limited English
their caregiver/support person(s) (or their discharge needs and the proficiency or physical, mental, or
both) to be active participants in self- development of a written discharge cognitive and intellectual disabilities
care and by implementing requirements plan. meaningful access to the discharge
that would improve patient transitions 3. Discharge Planning Process (Proposed planning process, as required under
from one care environment to another, § 482.43(c)) Title VI of the Civil Rights Act, as
while maintaining continuity in the implemented at 45 CFR 80.3(b)(2).
patient’s plan of care. The following is We propose at § 482.43(c), ‘‘Discharge Discharge planning would be of little
a discussion of each of the proposed planning process,’’ to require that value to patients who cannot
standards. hospitals implement a discharge understand or appropriately follow the
We propose at § 482.43, Discharge planning process to begin identifying, discharge plans discussed in this rule.
planning, to require that a hospital have early in the hospital stay, the Without appropriate language assistance
a discharge planning process that anticipated post-discharge goals, or auxiliary aids and services, discharge
focuses on the patient’s goals and preferences, and needs of the patient planners would not be able to fully
preferences and on preparing patients and begin to develop an appropriate involve the patient and caregiver/
and, as appropriate, their caregivers/ discharge plan for the patients support person in the development of
support person(s) to be active partners identified in proposed § 482.43(b). The the discharge plan. Furthermore, the
in their post-discharge care, ensuring average length of stay in the hospital discharge planner would not be fully
effective patient transitions from setting has decreased significantly since aware of the patient’s goals for
hospital to post-acute care while the current discharge planning discharge.
planning for post-discharge care that is standards were written. Timely Additionally, effective discharge
consistent with the patient’s goals of identification of the patient’s goals, planning will assist hospitals in
mstockstill on DSK4VPTVN1PROD with PROPOSALS2

care and treatment preferences, and preferences, and needs and complying with the U.S. Supreme
reducing the likelihood of hospital development of the discharge plan Court’s holding in Olmstead v. L.C. (527
readmissions. would reduce delays in the overall U.S. 581 (1999)), which found that the
discharge process. We propose to unjustified segregation of people with
1. Design (Proposed § 482.43(a)) require that the discharge plan be disabilities is a form of unlawful
In newly proposed § 482.43(a), we tailored to the unique goals, preferences discrimination under the ADA. We note
propose to establish a new standard, and needs of the patient. For example, that effective discharge planning may
‘‘Design’’, and would require that based on the anticipated discharge assist hospitals in ensuring that
hospital medical staff, nursing needs, a discharge plan in the early individuals being discharged who

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Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules 68133

in the IMPACT Act are finalized. Once with the patient or patient’s preparing the patient or their
these measures are finalized, providers representative. Furthermore, we believe caregiver(s)/support persons (or both)
will be required to use the measures as that hospitals will use their evaluation regarding post-discharge care.
directed by the appropriate regulations of the discharge planning process, with We propose at § 482.43(d)(1) that
and issuances. solicitation of feedback from other discharge instructions must be provided
As required by the IMPACT Act, providers and suppliers in the at the time of discharge to patients, or
hospitals must take into account data on community, as well as from patients and the patient’s caregiver/support person
quality measures and data on resource caregivers, to revise their timeframes, as (s), (or both) who are discharged home
use measures of PAC providers during needed. We encourage hospitals to make or who are referred to PAC services. We
the discharge planning process. We use of available health information are also proposing that practitioners/
would expect that the hospital would be technology, such as health information facilities (such as a HHA or hospice
available to discuss and answer patients exchanges, to enhance the efficiency agency and the patient’s PCP), receive
and their caregiver’s questions about and effectiveness of their discharge the patient’s discharge instructions at
their post-discharge options and needs. process. the time of discharge if the patient is
In order to increase patient We propose to re-designate and revise referred to follow up PAC services.
involvement in the discharge planning the requirement at current § 482.43(e) at Discharge instructions can be provided
process and to emphasize patient new § 482.43(c)(10). We would require to patients and their caregivers/support
preferences throughout the patient’s that the hospital assess its discharge person(s) in different ways, including in
course of treatment, we believe that planning process on a regular basis. We paper and electronic formats, depending
hospitals must consider the propose to require that the assessment on the needs, preferences, and
aforementioned data in light of the include ongoing review of a capabilities of the patients and
patient’s goals of care and treatment representative sample of discharge caregivers. We would expect that
preferences. For example, the hospital plans, including patients who were discharge instructions would be
could provide quality data on PAC readmitted within 30 days of a previous carefully designed to be easily
providers that are within the patient’s admission, to ensure that they are understood by the patient or the
preferred geographic area. In another responsive to patient discharge needs. patient’s caregiver/support person (or
instance, hospitals could provide This evaluation will assist hospitals to both). Resources on providing
quality data on HHAs based on the improve the discharge planning process. information that can be easily
patient’s need for continuing care post- We believe the evaluation can be understood by patients are readily
discharge and preference to receive this incorporated into the Quality available and we refer readers to the
care at home. Hospitals should assist Assessment and Performance National Standards for Culturally and
patients as they choose a high quality Improvement (QAPI) process, although Linguistically Appropriate Services in
PAC provider. However, we would we have not explicitly required this Health and Health Care (the National
expect that hospitals would not make coordination and solicit comments on CLAS Standards), for guidance on
decisions on PAC services on behalf of doing so. providing instructions in a culturally
patients and their families and and linguistically appropriate manner at
caregivers and instead focus on person- 4. Discharge to Home (Proposed
https://
centered care to increase patient § 482.43(d))
www.thinkculturalhealth.hhs.gov/
participation in post-discharge care We propose to re-designate and revise content/clas.asp. The National CLAS
decision making. Person-centered care the current requirement at § 482.43(c)(5) Standards are intended to advance
focuses on the patient as the locus of (which currently requires that as health equity, improve quality, and help
control, supported in making their own needed, the patient and family or eliminate health care disparities by
choices and having control over their interested persons be counseled to providing a blueprint for individuals
daily lives. prepare them for post-hospital care) as and health and health care organizations
We propose to re-designate and revise § 482.43(d), ‘‘Discharge to home,’’ to to implement culturally and
the current requirement set out at require that the discharge plan include, linguistically appropriate services.
§ 482.43(b)(5) at new § 482.43(c)(9). We but not be limited to, discharge In addition, as a best practice,
would require that the patient’s instructions for patients described in hospitals should confirm patient or the
discharge needs evaluation and proposed § 482.43(b) in order to better patient’s caregiver/support person’s (or
discharge plan be documented and prepare them for managing their health both) understanding of the discharge
completed on a timely basis, based on post-discharge. The phrase ‘‘patients instructions. We recommend that
the patient’s goals, preferences, discharged to home’’ would include, but hospitals consider the use of ‘‘teach-
strengths, and needs, so that appropriate not be limited to, those patients back’’ during discharge planning and
arrangements for post-hospital care are returning to their residence, or to the upon providing discharge instructions
made before discharge. This community if they do not have a to the patient. ‘‘Teach-back’’ is a way to
requirement would prevent the patient’s residence, who require follow-up with confirm that a practitioner has
discharge or transfer from being unduly their primary care provider (PCP) or a explained to the patient what he or she
delayed. We believe that in response to specialist; HHAs; hospice services; or needs to know in a manner that the
this requirement, hospitals would any other type of outpatient health care patient understands. Training on the use
establish more specific time frames for service. The phrase ‘‘patients discharged of ‘‘teach-back’’ to ensure patient
mstockstill on DSK4VPTVN1PROD with PROPOSALS2

completing the evaluation and discharge to home’’ would not refer to patients understanding of transition of care
plans based on the needs of their who are transferred to another inpatient planning and appropriate medication
patients and their own operations. All acute care hospital, inpatient hospice use is readily available and we refer
relevant patient information would be facility or a SNF. We believe that our readers to the following resource for
incorporated into the discharge plan to proposed revisions to the current information on the use of ‘‘teach-back’’:
facilitate its implementation and the requirement provide more clarity with http://www.teachbacktraining.org. At
discharge plan must be included in the respect to our proposed intent, and § 482.43(d)(2), we propose to set forth
patient’s medical record. The results of allow us to state more fully what we the minimum requirements for
the evaluation must also be discussed would expect in the way of better discharge instructions. The purpose of

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medication prescriptions. Many patients In addition to the patient receiving post-discharge follow-up.7 This study
do not realize that they will need to discharge instructions, it is important ‘‘found that a home visit within three
have prescriptions filled to continue the that the providers responsible for days, care coordination by a nurse (most
medication therapy that was started follow-up care with a patient (including frequently a registered nurse or
during their hospitalization/visit. A the primary care provider (PCP) or other advanced-practice nurse), and
delay in obtaining necessary medication practitioner) receive the necessary communication between the hospital
post-discharge could have significant medical information to support and the primary care provider were
adverse health effects. We believe continuity of care. We therefore propose components of transitional care that
patients or caregivers (or both) should at § 482.43(d)(3) to require that the were significantly associated with
be informed, in advance of the hospital hospital send the following information reduced short-term readmission rates.’’
discharge, of the anticipated need for to the practitioner (s) responsible for We do not propose to specify the
filling outpatient (discharge) follow up care, if the practitioner has mechanism(s) or timing of the follow-up
prescriptions, and have a plan on how been clearly identified: program so that hospitals can determine
they will obtain those medications. • A copy of the discharge instructions how to best meet the needs of their
When necessary, assistance should be and the discharge summary within 48 patient population. However, we note
offered to the patient with identifying a hours of the patient’s discharge; the importance of ensuring that
pharmacy to fill the prescriptions post- hospitals follow-up, post-discharge,
• Pending test results within 24 hours
discharge in a timely manner. In with their most vulnerable patients,
of their availability;
identifying a pharmacy, the hospital including those with behavioral health
should consider whether the patient has • All other necessary information as
conditions. We encourage hospitals to
prescription drug coverage that might specified in proposed § 482.43(e)(2).
consider the use of innovative, low-cost
require the patient to use a pharmacy We remind hospitals to provide this post-discharge tools and technologies
within the drug plan’s network and information in a manner that complies where health care providers and
direct the patient appropriately. with all applicable privacy and security caregivers can ask simple questions that
As part of the medication regulations. help identify at-risk individuals, that
reconciliation process, we encourage Finally, we propose a new can be utilized for identifying those at
practitioners to consult with their state’s § 482.43(d)(4) to require, for patients risk for readmissions.
PDMP. In section II.A.3 of this proposed discharged to home, that the hospital
rule we discuss the potential benefits as must establish a post-discharge follow- 5. Transfer of Patients to Another Health
well as the challenges associated with up process. Many studies have found Care Facility (Proposed § 482.43(e))
the use of PDMPs. Given these potential that many patients experience major We propose to re-designate and revise
benefits and challenges, we are adverse health events post-discharge. the standard currently set out at
soliciting comments on whether, as part These are often associated with § 482.43(d) as § 482.43(e), ‘‘Transfer of
of the medication reconciliation medication compliance. As one patients to another health care facility,’’
process, practitioners should be example, a study, funded by Agency for by clarifying our expectations of the
required to consult with their state’s Healthcare Research and Quality discharge and transfer of patients. We
PDMP to reconcile patient use of (AHRQ) and published in the Annals of would continue to require that all
controlled substances as documented by Internal Medicine, found that one in five hospitals communicate necessary
the PDMP, even if the practitioner is not patients has a complication or adverse information of patients who are
going to prescribe a controlled event after being discharged from the discharged with transfer to another
substance. hospital.5 Another study using data facility. The receiving facility may be
We propose a new requirement at from all Florida hospitals found that another hospital (including an inpatient
§ 482.43(d)(2)(v) that written 7.86 percent of hospital admissions psychiatric hospital or a CAH) or a PAC
instructions, in paper or electronic were potentially preventable, related to facility. We believe that the transition of
format (or both), would be provided to the original condition requiring the patient from one environment to
the patient, and that the instructions admission, and occurred within the first another should occur in a way that
would document follow-up care, several weeks after discharge.6 Post- promotes efficiency and patient safety,
appointments, pending and/or planned discharge telephone call programs can through the communication of
diagnostic tests, and any pertinent improve patient safety and patient necessary information between the
telephone numbers for practitioners that satisfaction, and may decrease the hospital and the receiving facility. We
might be involved in the patient’s likelihood of post-discharge adverse believe that the timely communication
follow-up care or for any providers/ events and hospital readmission. Post-
suppliers to whom the patient has been of necessary clinical information
discharge follow-up can help ensure between health care providers support
referred for follow-up care. The choice
that patients comprehend and adhere to continuity of patient care, improves
of format of the instructions should be
their discharge instructions and patient safety, and can reduce hospital
based on patient and caregiver needs,
medication regimens. Furthermore, readmissions. In 2014, many hospitals
preferences, and capabilities. Clear
post-discharge follow-up may identify were using certified electronic health
communication and discussions with
problems in initiating follow-up care records that capture and standardize
the patient or other caregivers (or both)
and detect complications of recovery clinical data necessary to ensure safe
for follow-up care are an important
early, resulting in early intervention, transition in care delivery.
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determinant of patient outcomes
improved outcomes, and reduced re- The current discharge requirement set
following hospitalization. Hospitals
should ascertain that the patient hospitalization. A recent meta-analysis out at § 482.43(d) requires hospitals that
understands their discharge found a number of studies dealing with transfer patients to another facility to
instructions. The major elements of any send with the patient (at the time of
5 Adverse Drug Events Occurring Following
follow-up care would be required to be
Hospital Discharge. Forster, et al., 2005. 7 Kim J. Verhaegh et al, ‘‘Transitional Care
written so that the patient, caregiver/ 6 Norbert Goldfield et al., ‘‘Identifying Potentially Interventions Prevent Hospital Readmissions for
support person can refer to them post- Preventable Readmissions,’’ Health Care Financing Adults with Chronic Illnesses,’’ Health Affairs, 33,
hospitalization. Review, Fall 2008. no. 9 (2014).

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practitioners to consult with their state’s hospitals, to another care environment. rural providers collaborate with each
PDMP. In section II.A.3 of this proposed We believe that our proposed revisions other to optimize the use of post-
rule, we discuss the potential benefits as would reduce the incidence of discharge providers in rural areas.
well as the challenges associated with preventable and costly readmissions, We propose to develop requirements
the use of PDMPs. Given these potential which are often due to avoidable in the form of five standards at
benefits and challenges, we are adverse events. In addition, under the § 485.642. We would require that all
soliciting comments on whether, as part IMPACT Act, CAHs must take into inpatients and certain categories of
of the medication reconciliation account quality measures, resource use outpatients be evaluated for their
process, practitioners should be measures, and other measures to assist discharge needs and that the CAH
required to consult with their state’s PAC providers, patients, and the develop a discharge plan. We also
PDMP to reconcile patient use of families of patients with discharge propose to require that the CAH provide
controlled substances as documented by planning, also in light of the treatment specific discharge instructions, as
the PDMP, even if the practitioner is not preferences of patients and the patient’s appropriate, for all patients.
going to prescribe a controlled goals of care. Given these concerns and We propose that each CAH’s
substance. the IMPACT Act mandate, we are discharge planning process must ensure
We propose to include these elements proposing new CAH discharge planning that the discharge needs of each patient
in the discharge plan so that there is a requirements. We are soliciting are identified and must result in the
clear and comprehensive summary for comments on the timeline for development of an appropriate
effective and efficient follow-up care implementation of the following discharge plan for each patient.
planning and implementation as the proposed CAH discharge planning We remind CAHs that they must
patient transitions from HHA services to requirements. continue to abide by federal civil rights
another appropriate health care setting. As discussed at length in section II.A. laws, including Title VI of the Civil
We note that many of the for hospitals, we maintain that Rights Act of 1964, the Americans with
aforementioned proposed medical discharge planning is an important Disabilities Act, and section 504 of the
information elements required to be sent component of successful transitions Rehabilitation Act of 1973, when
to the receiving facility or health care from the CAH setting. Due to the developing a discharge planning
practitioner may not be applicable to the availability of fewer health care process. To this end, CAHs should take
patient. Therefore, we would expect resources in a rural environment, it is reasonable steps to provide individuals
HHAs to include this information with important to keep CAH patients on the with limited English proficiency or
a ‘‘N/A’’ or other appropriate notation path to recovery by ensuring that the physical, mental, cognitive, and
next to each data element that does not CAH effectively communicates the intellectual disabilities meaningful
apply to the patient. We are soliciting discharge plan to the patient and those access to the discharge planning
comments on these proposed medical who will be providing support to the process, as required under Title VI of
information requirements. patient post-discharge. It is important the Civil Rights Act, as implemented at
that patients discharged to home from 45 CFR § 80.3(b)(2). Discharge planning
C. Critical Access Hospital Discharge would be of little value to patients who
CAHs have the necessary support and
Planning cannot understand or appropriately
access to the appropriate resources to
Sections 1820(e) and 1861 (mm) of the assist them with recovery. follow the discharge plans discussed in
Act provide that critical access hospitals While we propose that CAHs must this rule. Without appropriate language
participating in Medicare and Medicaid take into consideration the patient’s assistance or auxiliary aids and services,
meet certain specified requirements. We preferences and goals of care during the discharge planners would not be able to
have implemented these provisions in discharge planning process, as we fully involve the patient and caregiver/
42 CFR part 485, subpart F, Conditions describe in this proposed rule, we also support person in the development of
of Participation for CAHs. acknowledge that patients located in the discharge plan. Furthermore, the
Currently, there is no CAH discharge rural areas that are discharged from discharge planner would not be fully
planning CoP. When CMS established CAHs may have limited post-acute care aware of the patient’s goals for
requirements for the Essential Access options. discharge.
Community Hospital (EACH) and Rural Facilities that offer the most Additionally, effective discharge
Primary Care Hospital (RPCH) providers appropriate post-discharge care for a planning will assist CAHs in accordance
that participated in the seven-state particular patient’s recovery needs may with the U.S. Supreme Court’s holding
demonstration program in 1993, a be located outside of the patient’s in Olmstead vs. L.C., which found that
discharge planning CoP was not community. We therefore would expect the unjustified segregation of people
developed then. Minimally, what was CAHs to support patients as they choose with disabilities is a form of unlawful
required under the former EACH/RPCH an appropriate PAC setting that meets discrimination under the ADA. We note
program was adopted for the new CAH their preferences and goals of care, that effective discharge planning may
program (see 62 FR 45966 through while informing the patient of the assist CAHs in ensuring that individuals
46008, August 29, 1997). Currently the benefits of selecting the most being discharged, who would otherwise
CoPs at § 485.631(c)(2)(ii) provide that a appropriate setting for their post- be entitled to institutional services, have
CAH must arrange for, or refer patients discharge needs, even if the facility is access to community based services
to, needed services that cannot be outside of the patient’s desired location. when: (a) such placement is
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furnished at the CAH. CAHs are to Consistent communication between appropriate; (b) the affected person does
ensure that adequate patient health health care providers in all patient care not oppose such treatment; and (c) the
records are maintained and transferred settings would assist in better patient placement can be reasonably
as required when patients are referred. placement. However, this level of accommodated.
As previously noted, we recognize communication has not been
that there is significant benefit in consistently achieved among the 1. Design (Proposed § 485.642(a))
improving the transfer and discharge numerous healthcare providers within We propose at § 485.642(a) to
requirements from an inpatient acute communities across the country. establish a new standard, ‘‘Design,’’ to
care facility, such as CAHs and Therefore, we believe that it is vital that require a CAH to have policies and

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Furthermore, the CAH would have to periodic review of a representative going to prescribe a controlled
ensure that the PAC data on quality sample of discharge plans, including substance.
measures and data on resource use those patients who were readmitted In addition to the patient receiving
measures is relevant and applicable to within 30 days of a previous admission discharge instructions, it is important
the patient’s goals of care and treatment to ensure that they are responsive to that the providers responsible for
preferences. patient discharge needs. follow-up care with a patient (including
As required by the IMPACT Act, the PCP or other practitioner) receive
CAHs would have to take into account 4. Discharge to Home (Proposed the necessary medical information to
data on quality measures and data on § 485.642(d)(1) through (3)) support continuity of care. We therefore
resource use measures during the We propose at § 485.642(d)(1) to propose at § 485.642(d)(3) to require that
discharge planning process. In order to establish a new standard, ‘‘Discharge to the CAH send the following information
increase patient involvement in the home’’, to require that discharge to the practitioner(s) responsible for
discharge planning process and to instructions be provided at the time of follow up care, if the practitioner is
emphasize patient preferences discharge to the patient, or the patient’s known to the hospital and has been
throughout the patient’s course of caregiver/support person (or both). Also, clearly identified:
treatment, CAHs should tailor the data if the patient is referred to a PAC • A copy of the discharge instructions
on PAC provider quality measures and provider or supplier, the discharge and the discharge summary within 48
resource use measures to the patient’s instructions must be provided to the hours of the patient’s discharge;
goals of care and treatment preferences. PAC provider/supplier. Instruction on • Pending test results within 24 hours
For example, the CAH could provide the post-discharge care must include, but of their availability;
aforementioned quality data on PAC are not limited to, instruction on post- • All other necessary information as
providers that are within the patient’s discharge care to be used by the patient specified in proposed § 485.642(e)(2).
desired geographic area. In another or the caregiver/support person(s) in the We remind CAHs to provide this
instance, CAHs could provide quality patient’s home, as identified in the information in a manner that complies
data on HHAs based on the patient’s discharge plan. We also propose at with all applicable privacy and security
preference to continue their care upon § 485.642(d)(2) to require that the regulations. We would expect that
discharge to home. CAHs should assist instructions must include: discharge instructions would be
patients as they choose a high quality • Instruction on post-discharge care carefully designed and written in plain
PAC provider. However, we would to be used by the patient or the language and designed to be easily
expect that CAHs would not make caregiver/support person(s) in the understood by the patient or the
decisions on PAC services on behalf of patient’s home, as identified in the patient’s caregiver/support person (or
patients and their families and discharge plan; both). In addition, as a best practice,
caregivers and instead focus on person- • Written information on warning CAHs should confirm patient or the
centered care to increase patient signs and symptoms that may indicate patient’s caregiver/support person (or
participation in post-discharge care the need to seek immediate medical both) understanding of the discharge
decision making. Person-centered care attention; instructions. We recommend that CAHs
focuses on the patient as the locus of • Prescriptions for medications that consider the use of ‘‘teach-back’’ during
control, supported in making their own are required after discharge, including discharge planning and upon providing
choices and having control over their the name, indication, and dosage of discharge instructions to the patient. We
daily lives. each drug along with any significant refer readers to Section II. A. 3 for more
We propose at § 485.642(c)(9) to risks and side effects of each drug as resources on the ‘‘teach-back’’ method.
require that the evaluation of the appropriate to the patient; We propose at § 485.642(d)(4) to
patient’s discharge needs and discharge • Reconciliation of all discharge require CAHs to establish a post-
plan would have to be documented and medications with the patient’s pre- discharge follow-up process. We believe
completed on a timely basis, based on hospital admission/registration that post-discharge follow-up can help
the patient’s goals, preferences, medications (both prescribed and over- ensure that patients comprehend and
strengths, and needs. This will ensure the counter); and adhere to their discharge instruction
that appropriate arrangements for post- • Written instructions regarding the and medication regimens and improve
CAH care are made before discharge. We patient’s follow-up care, appointments, patient safety and satisfaction. We are
believe that the CAH would establish pending or planned diagnostic tests (or proposing that CAHs have the flexibility
more specific time frames for both), and pertinent contact to determine the appropriate time and
completing the evaluation and discharge information, including telephone mechanism of the follow up process to
plans based on the needs of their numbers for practitioners involved in meet the needs of their patients.
patients and their own operations. We follow-up care. However, we note the importance of
propose to require that the evaluation be As part of the medication ensuring that CAHs follow-up, post-
included in the medical record. The reconciliation process, we encourage discharge, with their most vulnerable
results of the evaluation must be practitioners to consult with their state’s patients, including those with
discussed with the patient or patient’s PDMP. In section II.A.3 of this proposed behavioral health conditions.
representative. All relevant patient rule, we discuss the potential benefits as
information would have to be well as the challenges associated with 5. Transfer of Patients to Another Health
Care Facility (Proposed § 485.642(e))
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incorporated into the discharge plan to the use of PDMPs. Given these potential
facilitate its implementation and to benefits and challenges, we are When a patient is transferred to
avoid unnecessary delays in the soliciting comments on whether, as part another facility, that is another CAH,
patient’s discharge or transfer. of the medication reconciliation hospital, or a PAC provider, we propose
We also propose at § 485.642(c)(10) to process, practitioners should be at § 485.642(e) to require that the CAH
require that the CAH assess its discharge required to consult with their state’s send necessary medical information to
planning process in accordance with the PDMP to reconcile patient use of the receiving facility at the time of
existing requirements at § 485.635(a)(4). controlled substances as documented by transfer. The necessary medical
The assessment must include ongoing, the PDMP, even if the practitioner is not information must include:

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the discharge summary to the patient’s discharge plan for each patient. The patient, and development of an
next source of healthcare services, for a current CAH CoP at § 485.635(d)(4) appropriate discharge plan for each
total of 62 hours per average HHA requires the CAH to develop a nursing patient for whom a discharge plan is
annually ((2.5 minutes per patient × care plan for each inpatient. The applicable in accordance with proposed
1,488 patients)/60 minutes per hour) at Interpretive Guidelines for § 485.642(b). The identification of the
a cost of $1,984 for an office employee § 485.635(d)(4) state that the plan patient’s needs and the development of
to send the required documentation includes planning the patient’s care the discharge plan must comply with all
($32 per hour × 62 hours). Complying while in the CAH as well as planning of the requirements in § 485.642(c)(1)
with this provision would require an for transfer to a hospital or a PAC through (9). Proposed § 485.642(c)(4)
estimated 739,660 hours (62 hours per facility or for discharge. Because the specifically would require that ‘‘The
HHA × 11,930 HHAs) and $24 million proposed CAH discharge planning licensed practitioner responsible for the
($1,984 per HHA × 11,930 HHAs) for all requirements mirror those proposed for care of the patient must be involved in
HHAs annually. hospitals, we believe that CAHs, like the ongoing process of establishing the
Thus, we estimate compliance with hospitals, are essentially already discharge plan.’’ The current CAH CoPs
this new CoP would cost HHAs a one- performing many of the proposed do not contain any similar requirement.
time cost of $34 million and requirements and estimate the burden to The burden associated with the
approximately $283 million annually. be minimal. We are assessing burden requirement that a practitioner
As previously indicated, these only for those areas that we believe that responsible for the patient’s care be
estimates are based on estimates for CAHs are not already doing under the involved with the patient’s discharge
hospitals and CAHs with the relevant current requirements of the nursing care would include the time needed for a
modifications for HHAs. We welcome plan at § 485.635(d)(4). practitioner to assist in establishing the
data and comments on these estimates. For proposed § 485.642(b), CAHs discharge plan. We believe that
C. ICRs Regarding Critical Access would need to shift from evaluating practitioner involvement in the
Hospital Discharge Planning (§ 485.642) patients for potential discharge planning establishing of the discharge plan would
to actually doing discharge planning for constitute a usual and customary
Currently, the CoPs at the vast majority of patients. CAHs business practice as defined in the
§ 485.631(c)(2)(ii) provide that a CAH would have to revise their policies and implementing regulations of the PRA at
must arrange for, or refer patients to, procedures to comply with the proposed 5 CFR 320.3(b)(2) and that CAHs are
needed services that cannot be requirements in this section. First, already doing this. The majority of
furnished at the CAH. CAHs are to CAHs would need to review their CAHs that are deemed for participation
ensure that adequate patient health current policies and procedures and in Medicare are accredited by The Joint
records are maintained and transferred update them so that they comply with Commission, which requires a CAH to
as required when patients are referred. the requirements in proposed § 485.642 have ‘‘the patient, the patient’s family,
As previously noted, we recognize (b). This would be a one-time burden on licensed independent practitioners,
that there is significant benefit in the CAH. We estimate that this would physicians, clinical psychologists, and
improving the transfer and discharge require a physician, a registered nurse, staff involved in the patient’s care,
requirements from an inpatient acute and an administrator using the average treatment, and services [emphasis
care facility, such as CAHs and hourly salaries as estimated in this added] participate in planning the
hospitals, to another care environment. proposed rule. Note that we are patient’s discharge or transfer.’’ Such
We believe that our proposed revisions estimating a lower average hourly salary practitioner involvement (where
would reduce the incidence of for a CAH administrator than that indicated and where feasible) is in our
preventable and costly readmissions, previously estimated for a hospital CEO/ view an essential part of patient care
which are often due to avoidable administrator. We estimate that each and one that we expect CAH staff
adverse events. In addition, the IMPACT person would spend 16 hours on this carefully follow wherever possible.
Act requires that hospitals and CAHs activity for a total of 48 hours per CAH Therefore, we will not be assessing any
take into account quality, resource use at a cost of $5,632 ((16 hours × $67 for burden for this activity.
data, and other data to assist PAC a registered nurse’s hourly salary) + (16 We believe that practitioners already
providers, patients, and the families of hours × $98 for an administrator’s are communicating with the staff that
patients with discharge planning, while hourly salary) + (16 hours × $187 for a are caring for their patients and that the
also addressing the treatment physician’s hourly salary)). For all practitioner’s involvement in the
preferences of patients and the patient’s CAHs to comply with this requirement, establishment of the discharge plan
goals of care. In light of these concerns we estimate a total one-time cost of would occur during those usual
and the requirements of the IMPACT approximately $7.5 million (1,328 CAHs interactions with the staff. We also
Act, we are proposing new CAH × $5,632). expect that practitioners would review
discharge planning requirements. Similar to the proposed hospital the discharge plan in conjunction with
We propose to develop requirements requirements at § 482.43(c), proposed their review of the patient’s CAH
in the form of new CoPs with five § 485.642(c) would require the CAH to medical record. The practitioner would
standards at § 485.642. We would implement a discharge planning process write the order to discharge the patient,
require that all patients be evaluated for that identifies, within 24 hours after as well as any prescriptions for
their discharge needs and that the CAH admission or registration in the CAH, medications and other orders for the
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develop a discharge plan. We also the anticipated discharge needs for the patient. However, the proposed
propose to require that the CAH provide patients identified under the proposed requirement envisions a more direct
specific discharge instructions, as requirement at § 485.642(b), along with involvement in the ongoing process of
appropriate, for all patients. several provisions supporting the establishing a discharge plan. Thus, we
We also propose that each CAH’s requirement proposed here. believe that practitioners would spend
discharge planning process must ensure Proposed § 485.642(c) would require more time discussing the discharge plan
that the discharge needs of each patient that the CAH’s discharge planning with nurses and other CAH personnel.
are identified and must result in the process promote early identification of The additional time the practitioner
development of an appropriate the anticipated discharge needs of each would be required to spend on

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discharge planning would vary greatly they are providing this care for all of burden for both of these subsections
in accordance with the patient’s need their patients. Of the approximately together.
for care, treatment, and services after he 600,000 patients discharged from CAHs The burden for reconciling pre-
or she was discharged from the CAH. each year, we estimate that about 60,000 admission/registration medications
Practitioners must already be involved additional patients would require (both prescribed and over-the-counter)
in many circumstances because they discharge planning to comply with the with the discharge medications would
must order or authorize certain post- requirement in this section. A nurse be the resources required to review the
discharge care. In addition, there is no would probably perform this activity at patient’s chart to identify all of a
need for a practitioner to spend an hourly salary of $67. This activity patient’s pre-admission medications and
additional time on discharge planning should require 30 minutes or 0.5 hours. compare them to the discharge
for patients who only require Thus, for the 1,328 CAHs, we estimate medications. Typically, a physician,
prescriptions for medications and an that complying with this requirement nurse, or other healthcare provider
order to follow-up with their primary would require 30,000 burden hours would do a history for each patient
care provider or those who pass away (60,000 patients × 0.5 hours) at a cost of upon admission. A nurse would usually
while hospitalized. We use the $2 million (30,000 × $67 hourly nurse’s then compare the medications the
following average hourly costs for a salary). Approximately 5 minutes of this patient was taking pre-admission to
physician, an advanced practice time would be spent consulting with those ordered by the practitioner and
registered nurse, and a physician either the MD/DO or the APRN/PA at a reconcile them. If there were any
assistant respectively: $187, $94, and cost of $702,180 (60,000 patients × 0.083 discrepancies that the nurse questioned,
$94. We believe that CAH APRNs and hours × $141 (($187 + $94)/2), resulting he or she would then consult with the
PAs would spend more time than in an approximate total of $2.7 million practitioner caring for the patient. When
physicians on discharge planning (5 annually. a patient is ready for discharge, the
minutes versus 2 minutes or 0.083 hours Whenever a patient is discharged or nurse would then compare the pre-
versus 0.033 hours). We estimate these transferred to another facility, proposed admission medications with the
practitioners would spend more time § 485.642(e) would require CAHs to discharge medications. If he or she
(approximately 0.083 hours per patient) send necessary medical information to questioned any changes, the nurse
on discharge planning for the receiving facility at the time of would need to question the prescribing
approximately 20 percent of CAH transfer. The necessary information that practitioner about the discrepancy.
patients or approximately 120,000 the CAH must send to the receiving Based on our experience with CAHs,
patients. We estimate physicians would facility includes all the items listed at we believe that a nurse would review
spend approximately 0.033 burden proposed § 485.642(e)(2)(i) through the patient’s chart and reconcile the pre-
hours on 5 percent of CAH patients or (viii). Currently, the CoPs at admission and discharge medications.
approximately 30,000 patients. Thus, § 485.631(c)(2)(ii) provide that a CAH The time required for this reconciliation
we estimate that complying with the must arrange for, or refer patients to, would vary greatly depending upon the
requirements in this section would cost needed services that cannot be number of medications a patient was
$1.1 million annually ((120,000 patients furnished at the CAH. CAHs are to taking, both pre-admission and at
× 0.083 hours × $94 average hourly wage ensure that adequate patient medical discharge, and the number of changes or
for APRNs and PAs) + (30,000 patients records are maintained and transferred discrepancies that the nurse questioned.
× 0.033 hours × $187 average hourly as required when patients are referred. We estimate that this activity would
wage for physicians)). We believe that CAHs are already require an average of 3 minutes for each
For proposed § 485.642(d), CAHs providing the information listed at patient or 0.05 hours. We estimate that
would be required to provide to all proposed § 485.642(d)(2)(i) through there are about 600,000 discharges
patients discharged to home, with or (viii), except for (ii), which specifically annually that would require this
without a referral to a community-based requires an assessment of functional medication reconciliation. Nurses earn
service provider, discharge instructions status, and (iv), which requires the an average hourly salary of $67. Thus,
that must include, at a minimum, those reconciliation of all discharge complying with this requirement would
items identified in § 485.642(d)(2)(i) medications with the patient’s pre-CAH require an estimated 30,000 burden
through (v). The current CAH CoPs do admission/registration medications hours (600,000 discharges × 0.05 hours
not contain any requirements for written (both prescribed and over-the counter), per patient) across all CAHs annually at
discharge instructions. including known allergies. Although we a cost of $2 million (30,000 burden
The burden from the requirement to believe all CAHs are ensuring that hours × $67).
include discharge instructions in the information about functional status and We welcome comments on these
discharge plan and document those about known allergies is being estimates and any available data that we
instructions is the resources needed to forwarded, we are not certain that they could use to improve our estimates.
develop the discharge plan and are all reconciling the pre-CAH Based on the previously stated
instructions. Based on our experience medications with the discharge estimates, to comply with all of the
with the 1,328 CAHs, we believe they medications. Therefore, we will analyze requirements in proposed § 485.642, we
are already doing some form of a burden for this reconciliation. Since estimate a total one-time cost of $7
discharge planning and providing both proposed § 485.642(d)(2)(iv) and million and a total annual cost of
discharge instructions for most of their § 482.642(e)(2)(iv) require medication approximately $6 million for CAHs
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patients. However, we do not believe reconciliation, we will assess the nationwide.

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benefits of available regulatory the budgetary impacts of entitlement The Congressional Review Act, 5
alternatives and, if regulation is grants, user fees, or loan programs or the U.S.C. 801 et. seq., as added by the
necessary, to select regulatory rights and obligations of recipients Small Business Regulatory Enforcement
approaches that maximize net benefits thereof; or (4) raising novel legal or Fairness Act of 1996, provides that
(including potential economic, policy issues arising out of legal before a rule may take effect, the agency
environmental, public health and safety mandates, the President’s priorities, or promulgating the rule must submit a
effects, distributive impacts, and the principles set forth in the Executive rule report, which includes a copy of
equity). Section 3(f) of Executive Order Order. the rule, to each House of the Congress
12866 defines a ‘‘significant regulatory and to the Comptroller General of the
action’’ as an action that is likely to A regulatory impact analysis (RIA)
must be prepared for major rules with United States. HHS will submit a report
result in a rule: (1) (Having an annual containing this rule and other required
effect on the economy of $100 million economically significant effects ($100
million or more in any 1 year). We information to the U.S. Senate, the U.S.
or more in any 1 year, or adversely and House of Representatives, and the
materially affecting a sector of the estimate that this rulemaking is
‘‘economically significant’’ as measured Comptroller General of the United
economy, productivity, competition,
by the $100 million threshold, and States prior to publication of the rule in
jobs, the environment, public health or
hence also a major rule under the the Federal Register.
safety, or state, local or tribal
governments or communities (also Congressional Review Act. Accordingly, This proposed rule would create both
referred to as ‘‘economically we have prepared a RIA that, taken one-time and annual costs for CAHs and
significant’’); (2) creating a serious together with the ICR section and other HHAs. The financial costs are
inconsistency or otherwise interfering sections of the preamble, presents our summarized in the table that follows.
with an action taken or planned by best estimates of the effects costs and We welcome public comments on all of
another agency; (3) materially altering benefits of the rulemaking. our burden assumptions and estimates.

TABLE 2—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES*
Number of Likely
Provider/Supplier Frequency affected ($ millions)
entities

Hospitals (§ 482.43) ...................................................... One-time ....................................................................... 4,900 17
Recurring Annually ....................................................... 107
CAHs (§ 485.642) ......................................................... One-time ....................................................................... 1,328 7
Recurring Annually ....................................................... 6
HHAs (§ 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 our view, hospitals already counsel uncertainty. While the Department of
patients on these choices, and the Health and Human Services is confident
1. Effects on Hospitals (Including
availability of written quality that these proposals will provide
LTCHs and IRFs), CAHs, and HHAs
information will not add significantly to flexibilities to facilities that will
We have accounted for the regulatory the time involved, and may in some minimize cost increases, there are
impact of these proposed changes cases reduce it (the information, of uncertainties about the magnitude of the
through the analysis of costs contained course, would only be presented as discussed effects. However, we have
in the ICR sections previously pertinent to the particular decisions based our overall assumptions and best
mentioned in this proposed rule. We facing particular patients). Indeed, all estimates on our ongoing experiences
believe these estimates encompass all providers affected by this rule already with hospitals, CAHs, and HHAs in
additional burden on hospitals, CAHs have access to quality information from these matters. We welcome public
and HHAs. Any burden associated with the CMS Web sites Hospital Compare, comments on these assumptions and
the proposed changes to the CoPs not Nursing Home Compare, and Home estimates.
accounted for in the ICR sections or in Health Compare, as well as other public In addition, as we previously
the RIA section was omitted because we and private Web sites and their own explained, there may be significant
believe it would constitute a usual and knowledge of local providers, and additional health benefits, such as the
customary business practice and would presumably many or most use this reduction in patient readmissions after
not be subject to the PRA in accordance information as appropriate to counsel discharges and the reduction of other
with 5 CFR 1320.3(b)(2). Nor would it patients. If readers believe we have post-discharge patient complications.
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constitute an added cost for purposes of omitted some category of cost by
incorrectly assuming it is already being 2. Effects on Small Entities
RIA estimates if we added a regulatory
requirement that reflected existing performed, or to have unnecessarily The RFA requires agencies to analyze
practices and workload. We note that presented cost estimates for functions options for regulatory relief of small
we do not estimate costs for the newly that are already being performed, we entities, if a rule has a significant impact
added requirement to present quality would welcome comments on these on a substantial number of small
and cost information to those hospital areas of the proposed rule. entities. For purposes of the RFA, we
patients who face a decision on Our estimates of the effects of this estimate that the great majority of the
selection of post-discharge providers. In regulation are subject to significant providers that would be affected by our

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Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules 68149

rules are small entities as that term is approximately $6 million nationally, or the provisions of section 603 of the
used in the RFA. The great majority of about $4,600 per hospital (revenue data RFA. For purposes of section 1102(b) of
hospitals and most other healthcare from MEDPAC report ‘‘Critical Access the Act, we define a small rural hospital
providers and suppliers are small Hospitals Payment System’’ at http:// as a hospital that is located outside of
entities, either by being nonprofit www.medpac.gov/documents/payment- a metropolitan statistical area and has
organizations or by meeting the SBA basics/critical-access-hospitals- fewer than 100 beds. For the preceding
definition of a small business. payment-system-14.pdf?sfvrsn=0). reasons, we have determined that this
Accordingly, the usual practice of HHS Assuming conservatively that one-half proposed rule does not have a
is to treat all providers and suppliers as of all CAH patients are Medicare significant impact on the operations of
small entities in analyzing the effects of beneficiaries, and that Medicare a substantial number of small rural
our rules. accounts for a like percentage of hospitals.
As shown in table 1, we estimate that revenues, this would be a small fraction Section 202 of the Unfunded
the recurring costs of this proposed rule of 1 percent of annual revenues (or, as Mandates Reform Act of 1995 (UMRA)
would cost affected entities is roughly equivalent, annual costs). The also requires that agencies assess
approximately $396 million a year (out HHS threshold used for determining anticipated costs and benefits before
of the total first year cost of $454 significant economic effect on small issuing any rule whose mandates
million a year). A majority of these costs entities is 3 percent of costs. require spending in any 1 year of $100
would impact HHAs. While this is a Accordingly, after a review of cost million in 1995 dollars, updated
large amount in total, the average effects on HHAs, hospitals, and CAHs, annually for inflation. In 2015, that is
annual costs per affected HHA are only we have determined that this proposed approximately $157 million. This
about $24,000 per year ($283 million in rule would not have a significant proposed rule would require HHA
total for all HHAs/11,930 HHAs). economic impact on a substantial spending in excess of that threshold, at
Although the overall magnitude of the number of small entities, and certify least in early years before subsequent
paperwork, staffing, and related costs to that an initial RFA is not required. payment rate increases may take
HHAs under this rule is economically We note that quite apart from the increased costs into account. Mandated
significant, these costs are about 1 gross costs of compliance being a small spending for CAHs, in contrast, is
percent of total HHA costs. According to fraction of revenues or costs of affected largely reimbursed on a cost basis and
the 2014 Annual Report of the Medicare entities, net costs will be far smaller. would not count as an unfunded
trustees, the total annual spending on Payment for hospital inpatient services mandate. This RIA and the preamble as
HHA services from Medicare Parts A for Medicare beneficiaries is paid presented together here in this proposed
and B, not including private payments, primarily according to Medicare rule meet the UMRA requirements for
was $18.4 billion in 2013. Our estimated severity diagnosis-related groups (MS– analysis.
annual cost is 1.5 percent of that total DRGs), and MS–DRGs for hospital Executive Order 13132 establishes
($283 million/$l8.4 billion), and as a per procedures are periodically revised to certain requirements that an agency
patient cost would be approximately reflect the latest estimates of costs from must meet when it issues a proposed
that same percentage (less, if private hospitals themselves, as well as from rule (and subsequent final rule) that
spending were included) for all HHAs. other sources. Hence, absent offsetting would impose substantial direct
Accordingly, we have concluded that effects from other payment changes, and requirement costs on state and local
the costs of this proposed rule will not depending on hospitals’ success in governments, preempts state law, or
reach 3 percent of revenues, the controlling overall costs, some portion otherwise has Federalism implications.
threshold used by HHS to determine of these costs will be recovered from This rule would not have a substantial
whether a proposed rule is likely to Medicare. Moreover, hospitals can and direct effect on state or local
create a negative ‘‘significant impact on do periodically revise their charges to governments, preempt states, or
a substantial number of small entities,’’ private insurance carriers (subject in otherwise have a Federalism
and thereby trigger the requirement for part to negotiations over rates) and for implication.
an initial Regulatory Flexibility the approximately half of all patients 3. Effects on Patients and Medical Care
Analysis. who are ‘‘private pay’’ cost increases Costs
Effects on hospitals are far smaller, can be partially offset in that way. As for
and estimated to be about $107 million CAHs, they are largely paid on a cost Patients in all three settings are the
annually in recurring costs. Total basis for their Medicare patients, and major beneficiaries of this rule. Research
annual expenses for all hospitals are will presumably be able to recoup cited earlier in this preamble strongly
about $859 billion a year.9 The additional costs through periodic suggests that there would be reductions
estimated costs of this rule would be adjustments to public and private in morbidity and mortality from
approximately one hundredth of one payment rates. Finally, HHAs also improving services to these patients
percent of this expenditure amount and, obtain periodic changes in payment through improved discharge planning.
since revenues and costs are roughly rates from both public and private We are unable to quantify either the
equal, an equally small percent of payers. In all three cases, we have no volume or dollar value of expected
revenues. way to predict precise future pathways benefits. We are not aware of reliable
Total national CAH revenues from or exact timing however, we believe that empirical data on the benefits of
Medicare are approximately $9 billion a most of the recurring costs (and almost improved discharge planning. In
mstockstill on DSK4VPTVN1PROD with PROPOSALS2

year, or an average of about $7 million all in the case of CAHs) will be addition, there are multiple initiatives
annually per hospital ($9 billion/1,328). recovered through payments from third affecting the same patients (for example,
We believe that all or almost all CAHs party payers, public and private. the Hospital Readmissions Reduction
meet the size threshold for small In addition, section 1102(b) of the Act Program, the Medicare EHR Incentive
entities. We estimate that this proposed requires us to prepare a regulatory Program, and the Accountable Care
rule would impose costs of impact analysis if a rule may have a Organizations under the Medicare
significant impact on the operations of Shared Savings Program). This makes it
9 http://www.aha.org/research/rc/stat-studies/ a substantial number of small rural challenging to sort out the separable
fast-facts.shtml hospitals. This analysis must conform to benefits of this proposed rule.

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68150 Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules

Nonetheless, the number of patients discharge follow-up procedures, but enforcement standards for a possible
potentially benefitting is significant. concluded that the range of procedures mandatory requirement.
There are roughly 35 million inpatient is so great (including, for example, such For all provisions, we attempted to
discharges from hospitals annually. In very low cost procedures as minimize unnecessarily prescriptive
addition, there are approximately 32 automatically generated text or email methods or procedures, and to avoid
million patients newly affected by reminders about medication any unnecessarily costly requirements.
substantially modified discharge compliance, and such high cost We welcome comments on whether we
planning requirements (this figure procedures as home visits by nurses), properly selected the best provisions for
includes an additional 13 million and the range of patient situations so change and on whether there are
annual hospital outpatient discharges, wide (including in many cases no likely alternatives or improvements to the
18 million annual HHA patient benefit from follow-up and in others no proposed provisions that would
discharges, and 600,000 annual CAH efficient way to predict likely benefits), increase benefits at reasonable cost or
discharges). If mortality or serious that no reasonable or practicable reduce costs without compromising
morbidity were prevented for even a requirement could be devised at this important benefits.
fraction of 1 percent of these nearly 50 time. Of course, we encourage providers
million patients, potentially tens or to use follow-up procedures they find E. Cost to the Federal Government
hundreds of thousands of persons cost-effective for particular categories of
would substantially benefit. patients. We welcome comments and If these requirements are finalized,
There are existing requirements in data on these or other follow-up CMS will update the interpretive
place for discharge planning and for alternatives that may have been shown guidance, update the survey process,
reducing adverse events such as to be cost-effective in discharge and provide training. In order to
hospital readmissions, both in planning, and on what form and with implement these new standards, we
regulations governing patient care and what enforcement standards a anticipate initial federal startup costs
in payment regulations, but little or no mandatory requirement might between $8 to $10 million. The
data on the effectiveness of these reasonably use. continuing costs (survey process-
requirements compared to the normal We also considered proposing recertifications, enforcement, appeals,
effects of good medical practice. The mandatory use of the approximately 50 AO) are estimated $4,461,131 and will
changes that would be implemented by state-run PDMPs by providers regulated continue annually, thereafter. CMS will
this proposed rule are an additional under this proposed rule (each state has continue to examine and seeks comment
overlay on top of existing practices and its own version and operational, on the potential impacts to both
requirements. It is challenging to security, access, and other details vary Medicare and Medicaid.
disentangle all these overlapping by state). Where hospitals in particular F. Accounting Statement
factors. Therefore, existing data states voluntarily use such programs
demonstrate that even small based on their own determination of As required by OMB Circular A–4
improvements can have effects as large utility, we strongly encourage use of (available at http://
as those previously suggested in this such systems. PDMPs have proven www.whitehouse.gov/omb/circulars_
proposed rule. For example, one meta- useful for law enforcement purposes a004_a-4), in Table 2 we present an
analysis showed that transitional care and, in some states, for pharmacy use. accounting statement showing the
that promotes the safe and timely There are, however, uncertainties as to classification of the costs and benefits
transfer of patients from hospital to use in hospital settings. As one recent associated with the provisions of this
home has been proven to be highly study stated, ‘‘whether mandates should final rule. The accounting statement is
effective in reducing readmissions.10 become a best practice depends on based on estimates provided in this
We welcome comments that would proving their [PDMP] feasibility and regulatory impact analysis. We have
provide evidence in regard to these benefits.’’ 11 As discussed earlier in the used as an estimating horizon a 5 year
findings. preamble, there are also questions about period, but expect that annualized costs
‘‘legal, technical, privacy, or security would remain essentially the same over
D. Alternatives Considered challenges’’ of provider use of PDMPs, a longer period, after the initial year. For
As we previously stated in this including difficulties of use with purposes of this table, we have used a
proposed rule, some of these provisions EHRs.12 Regardless, we need current low estimate that is 25 percent lower
are mandated under the IMPACT Act, information on whether and where than our primary estimate, and a high
therefore, no major alternatives were PDMPs have been used effectively and estimate that is 25 percent higher than
considered. For the other proposed at reasonable cost in hospital discharge our primary estimate. As previously
provisions, we considered not making planning.13 Accordingly, we solicit discussed, we have no empirical data or
these changes. We did not consider comments that provide specific results from previous studies that would
additional requirements that we did not information on the feasibility, costs, and allow a defensible estimate of
believe would result in substantial patient benefits of using PDMP systems annualized benefits in terms of
benefits at reasonable cost. For example, in hospital discharge planning, and on morbidity and mortality prevented, and
we considered requiring specific post- workable implementation and medical costs avoided.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2

10 Kim J. Verhhaegh et al., ‘‘Transitional Care www.pdmpexcellence.org/sites/all/pdfs/Brandeis_ 13 See the case studies in the 2013 report

Interventions Prevent Hospital Readmissions for PDMP_Report_final.pdf. Connecting for Impact: Integrating Health IT and
Adults with Chronic Illnesses,’’ Health Affairs, 33, 12 HHS report to the Congress, Prescription Drug PDMPs to Improve Patient Care, The Mitre
no. 9 (2014):1531–1539. Corporation, at https://www.healthit.gov/sites/
11 Thomas Clark, John Eadie, Peter Kreiner, and
Monitoring Program Interoperability Standards,
September 2013, section on ‘‘Assessment of Legal, default/files/connecting_for_impact-final-508.pdf.
Gail Strickler. Prescription Drug Monitoring
Technical, Fiscal, Privacy, and Security https://www.healthit.gov/sites/default/files/
Programs: An Assessment of the Evidence for Best
Practices. A study prepared for the PEW Charitable Challenges,’’ at https://www.healthit.gov/sites/ connecting_for_impact-final-508.pdf.
Trusts. September 20, 2012. At: http:// default/files/fdasia1141report_final.pdf.

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$Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Proposed Rules 68155 caregiver/support person(s) should do (iii) All other necessary medical (xiii) Reconciliation of all discharge and who they should contact if these information as specified in medications with the patient’s pre-CAH warning signs or symptoms present; § 485.642(e)(2). admission/registration medications (iii) Prescriptions for medications that (4) The CAH must establish a post- (both prescribed and over-the-counter); are required after discharge, including a discharge follow-up process. (xiv) All known allergies, including list of name, indication, and dosage of (e) Standard: Transfer of patients to medication allergies; each drug, along with any significant another health care facility. (1) The (xv) Immunizations; risks and side effects of each drug as CAH must send necessary medical (xvi) Smoking status; appropriate to the patient; information to the receiving facility at (xvii) Vital signs; (iv) Reconciliation of all discharge the time of transfer. (xviii) Unique device identifier(s) for medications with the patient’s pre-CAH (2) Necessary medical information a patient’s implantable device(s), if any; admission/registration medications includes: (i) Demographic information, (xix) All special instructions or (both prescribed and over-the-counter); precautions for ongoing care, as and including but not limited to name, sex, date of birth, race, ethnicity, preferred appropriate; (v) Written instructions regarding the (xx) Patient’s goals and treatment patient’s follow-up care, appointments, language; (ii) Contact information for the preferences; and pending and/or planned diagnostic (xxi) Any other necessary information tests, and pertinent contact information, practitioner responsible for the care of the patient, as described at paragraph including a copy of the patient’s including telephone numbers, for discharge instructions, the discharge practitioners involved in follow-up care (b)(4) of this section, and the patient’s caregiver/support person(s), if summary, and any other documentation or for any providers/suppliers to whom as applicable, to ensure a safe and the patient has been referred for follow- applicable; (iii) Advance directive, if applicable; effective transition of care that supports up care. the post-discharge goals for the patient. (iv) Course of illness/treatment; (3) The CAH must send the following (v) Procedures; information to the practitioner(s) Dated: October 19, 2015. (vi) Diagnoses; Andrew M. Slavitt, responsible for follow up care, if the (vii) Laboratory tests and the results of practitioner is known and has been Acting Administrator, Centers for Medicare pertinent laboratory and other & Medicaid Services. clearly identified: diagnostic testing; (i) A copy of the discharge Approved: October 22, 2015. (viii) Consultation results; instructions and the discharge summary (ix) Functional status assessment; Sylvia M. Burwell, within 48 hours of the patient’s (x) Psychosocial assessment, Secretary, Department of Health and Human discharge; including cognitive status; Services. (ii) Pending test results within 24 (xi) Social supports; [FR Doc. 2015–27840 Filed 10–29–15; 8:45 am] hours of their availability; (xii) Behavioral health issues; BILLING CODE 4120–01–P mstockstill on DSK4VPTVN1PROD with PROPOSALS2 VerDate Sep<11>2014 19:54 Nov 02, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4701 Sfmt 9990 E:\FR\FM\03NOP2.SGM 03NOP2$
Document Created: 2018-03-01 11:32:48
Document Modified: 2018-03-01 11:32:48
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		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		Grant Programs-Health; Hospitals; Medicaid; Medicare; Reporting and Recordkeeping Requirements; Health Facilities; Health Professions and Grant Programs-Health
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 SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 212 (November 3, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
