[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51836-51884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20732]



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Vol. 84

Monday,

No. 189

September 30, 2019

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 482, 484, and 485





Medicare and Medicaid Programs; Revisions to Requirements for Discharge 
Planning for Hospitals, Critical Access Hospitals, and Home Health 
Agencies, and Hospital and Critical Access Hospital Changes To Promote 
Innovation, Flexibility, and Improvement in Patient Care; Final Rule

  Federal Register / Vol. 84 , No. 189 / Monday, September 30, 2019 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 482, 484, and 485

[CMS-3317-F and CMS-3295-F]
RIN 0938-AS59


Medicare and Medicaid Programs; Revisions to Requirements for 
Discharge Planning for Hospitals, Critical Access Hospitals, and Home 
Health Agencies, and Hospital and Critical Access Hospital Changes to 
Promote Innovation, Flexibility, and Improvement in Patient Care

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule empowers patients to be active participants in 
the discharge planning process and complements efforts around 
interoperability that focus on the seamless exchange of patient 
information between health care settings by revising the discharge 
planning requirements that Hospitals (including Short-Term Acute-Care 
Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, 
Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), 
Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must 
meet in order to participate in the Medicare and Medicaid programs. 
This final rule also implements discharge planning requirements which 
will give 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, which may 
ultimately reduce their chances of being re-hospitalized. It also 
updates one provision regarding patient rights in hospitals, intended 
to promote innovation and flexibility and to improve patient care.

DATES: These regulations are effective on November 29, 2019.

FOR FURTHER INFORMATION CONTACT: Alpha-Banu Wilson, (410) 786-8687, 
Kianna Banks, (410) 786-3498, CAPT Scott Cooper, USPHS, (410) 786-9465, 
Eric Laib (410) 786-9759, and Danielle Shearer, (410) 786-6617.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

Table of Contents

I. Background
    A. Overview
    B. IMPACT Act
II. Provisions of the Proposed Regulations and Responses to Public 
Comments
    A. General Comments
    B. Discharge Planning Requirements of the IMPACT Act of 2014 
(Proposed Sec.  482.43(c)(8), Proposed Sec.  484.58(a)(6), and 
Proposed Sec.  485.642(c)(8))
    C. Implementation
    D. Prescription Drug Monitoring Programs (PDMPs)
    E. Patients' Rights and Discharge Planning in Hospitals
    1. Patient's Access to Medical Records (Proposed Sec.  
482.13(d)(2))
    2. Conditions of Participation (CoP)--Discharge Planning 
(Proposed Sec.  482.43)
    3. Design (Proposed Sec.  482.43(a))
    4. Applicability (Proposed Sec.  482.43(b))
    5. Discharge Planning Process (Proposed Sec.  482.43(c))
    6. Discharge to Home (Proposed Sec.  482.43(d))
    7. Transfer of Patients to Another Health Care Facility 
(Proposed Sec.  482.43(e))
    8. Requirements for Post-Acute Care (PAC) Services (Proposed 
Sec.  482.43(f))
    F. Home Health Agency Discharge Planning (Proposed Sec.  484.58)
    1. Discharge Planning Process (Proposed Sec.  484.58(a))
    2. Discharge or Transfer Summary Content (Proposed Sec.  
484.58(b))
    G. Critical Access Hospital Discharge Planning (Proposed Sec.  
485.642)
    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. Provisions of the Final Regulations
IV. 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)
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Alternatives Considered
    E. Cost to the Federal Government
    F. Accounting Statement
    G. Regulatory Reform Analysis Under Executive Order 13771
    H. Congressional Review Act

I. Background

A. Overview

    On November 3, 2015, we published a proposed rule that would update 
the discharge planning requirements for hospitals, critical access 
hospitals (CAHs), and post-acute care (PAC) settings (80 FR 68126). 
Discharge planning is an important component of a successful transition 
from hospitals and PAC settings. The transition may be to a patient's 
home (with or without PAC services), skilled nursing facility (SNF), 
nursing facility (NF), long term care hospital (LTCH), rehabilitation 
hospital or unit, assisted living center, substance abuse treatment 
program, hospice, or a variety of other settings. While Medicare 
regulations define ``post-acute care'' providers to include SNFs, 
LTCHs, inpatient rehabilitation facilities (IRFs) and home health 
agencies (HHAs), it should be noted that there are other services that 
can be provided by entities other than PAC providers (that is, LTCHs, 
IRFs, HHAs, and SNFs), including assisted living facilities, home and 
community-based services, or primary care providers. 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.
    We also proposed to implement the discharge planning requirements 
of the Improving Medicare Post-Acute Care Transformation Act of 2014 
(IMPACT Act) (Pub. L. 113-185), that requires hospitals, including, but 
not limited to, short-term acute care hospitals, CAHs and PAC providers 
(LTCHs, IRFs, HHAs, and SNFs), to take into account quality measures 
and resource use measures to assist patients and their families during 
the discharge planning process in order to encourage patients and their 
families to become active participants in the planning of their 
transition to the PAC or other settings (or between such settings).
    We published another proposed rule on June 16, 2016 in the Federal 
Register, titled ``Medicare and Medicaid Programs; Hospital and 
Critical Access Hospital (CAH) Changes to Promote Innovation, 
Flexibility, and Improvement in Patient Care'' (81 FR 39448), 
hereinafter referred to as the ``Hospital Innovation proposed rule'', 
that proposed to update a number of Conditions of Participation (CoP) 
requirements that hospitals and CAHs must meet in order to participate 
in the Medicare and Medicaid programs. One of the proposed hospital CoP 
revisions in that rule directly addresses the issues

[[Page 51837]]

of communication between providers and patients and patient access to 
their medical records. We proposed that patients have the right to 
access their medical records, upon an oral or written request, in the 
form and format requested by such patients, if it is readily producible 
in such form and format (including in an electronic form or format when 
such medical records are maintained electronically); or, if not, in a 
readable hard copy form or such other form and format as agreed to by 
the facility and the patient, including current medical records, within 
a reasonable time frame. The hospital could not frustrate the 
legitimate efforts of patients to gain access to their own medical 
records and would have to actively seek to meet these requests as 
quickly as its record keeping system permitted.
    In accordance with Executive Order 13813, which promotes healthcare 
choice and competition across the country, and in line with HHS' goals 
to improve interoperability between patients and their health care 
providers, we are finalizing certain discharge planning requirements 
for hospitals (including Short-Term Acute-Care Hospitals, LTCHs, 
Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, 
and Cancer Hospitals), HHAs, and CAHs as well as finalizing the 
hospital patients' rights requirement regarding patient access to 
medical records. We are also finalizing the requirements of the IMPACT 
Act for hospitals, HHAs, and CAHs. We believe that these final 
requirements will empower patients to be active participants in the 
discharge planning process and will help them to make informed choices 
about their care, which may lead to more competition, lower costs, and 
improved quality of care. Furthermore, the IMPACT Act requirements will 
give 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 who are well informed of their choices of high-quality 
PAC providers may reduce their chances of being re-hospitalized.
    We also believe these final requirements will complement efforts 
around interoperability that focus on the seamless exchange of patient 
information between health care settings. Ultimately, these final 
requirements will ensure that a patient's health care information 
follows them after discharge from a hospital or PAC provider to their 
receiving health care facility, medical professional, or caregiver, as 
applicable.

B. IMPACT Act

    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 section 1899B to the Social Security Act (the Act). 
Section 1899B of the Act 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 of the IMPACT Act varies for the 
standardized assessment data described in subsection (b) of the Act, 
data on quality measures described in subsection (c) of the Act, and 
data on resource use and other measures described in subsection (d) of 
section 1899B of the Act. We note that many of these PAC provisions are 
being addressed in separate rulemakings. More information can be found 
on the CMS website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html.
    Section 1899B(j) of the Act requires that we allow for stakeholder 
input, such as through town hall meetings, open door forums, and 
mailbox submissions, before the initial rulemaking process to implement 
section 1899B of the Act. To meet this requirement, we provided the 
following opportunities for stakeholder input: (1) On February 3, 2015 
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; (2) provided two separate listening sessions 
on February 10 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; (3) in January 2015 we 
implemented a public mail box for the submission of comments located at 
[email protected]. The CMS public mailbox can be 
accessed on our PAC quality initiatives website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/Submit-a-Question-or-Feedback.html; (4) held a National Stakeholder Special Open Door Forum 
on February 25, 2015 to seek input on the measures; and (5) sought 
public input during the February 2015 ad hoc Measure Applications 
Partnership (MAP) process meeting regarding the measures under 
consideration with respect to the IMPACT Act domains. Section 1899B(i) 
of the Act, which addresses discharge planning, requires the 
modification of the 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 of the Act in the discharge planning process.
    We proposed to implement the discharge planning requirements 
mandated in section 1899B(i) of the Act by modifying the discharge 
planning or discharge summary CoPs for hospitals, CAHs and HHAs. As 
stated above, the IMPACT Act added section 1899B to the Act. 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 hospitals (including their Inpatient Prospective 
Payment System (IPPS), excluded rehabilitation or psychiatric units), 
rehabilitation hospitals, psychiatric hospitals, children's hospitals, 
and cancer hospitals) are all classifications of hospitals. All 
classifications of hospitals (as well as distinct part

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psychiatric and rehabilitation units in CAHs) are subject to most of 
the same core hospital CoPs. Therefore, these PAC providers (including 
freestanding LTCHs and IRFs) are also subject to the revisions to the 
hospital CoPs. We finalized the discharge planning requirements for 
SNFs and NFs in a final rule published on October 4, 2016 in the 
Federal Register, titled ``Medicare and Medicaid Programs; Reform of 
Requirements for Long-Term Care Facilities'' (81 FR 68688). The various 
providers' compliance with these requirements is assessed through on-
site surveys by CMS, State Survey Agencies (SAs) or national 
accrediting organizations (AOs) that have CMS-approved Medicare 
accreditation programs.

II. Provisions of the Proposed Regulations and Responses to Public 
Comments

    On November 3, 2015, we published a proposed rule in the Federal 
Register, titled ``Revisions to Requirements for Discharge Planning for 
Hospitals, Critical Access Hospitals, and Home Health Agencies'' (80 FR 
68126), hereinafter referred to as the ``Discharge Planning proposed 
rule,'' that would revise the discharge planning requirements that 
hospitals (including, but not limited to, LTCHs and IRFs), CAHs, and 
HHAs must meet in order to participate in the Medicare and Medicaid 
programs. In addition, we proposed to implement the discharge planning 
requirements of the IMPACT Act. In response to the proposed rule, we 
received 299 public comments. Commenters included individuals, health 
care professionals and corporations, national associations and 
coalitions, state health departments, patient advocacy organizations, 
and individual facilities that will be impacted by the rule. Generally, 
most comments centered on the hospital requirements, but could be 
applied to all provider types included in the proposed rule. We also 
received various comments in response to our solicitation for comments 
related to specific proposals.
    In response to the Hospital Innovation proposed rule, we received 
200 public comments, of which a small portion were centered on the 
proposed patient's right to access his or her own medical information 
requirement. This proposed revision to the hospital Patients' Rights 
CoP directly addressed the issues of communication between providers 
and patients and patient access to their medical records. Therefore, we 
are finalizing a patients' right provision at 42 CFR 482.13 that we 
proposed in the Hospital Innovation proposed rule. The provision we are 
finalizing here ensures a patient's right to access his or her own 
medical information from a hospital. This is the only provision of that 
rule that we are finalizing in this final rule. We are continuing to 
consider comments on the remaining portion of the Hospital Innovation 
proposed rule, and we will respond to those comments when we finalize 
that rule in future rulemaking.
    In this final rule, we provide a summary of our proposed 
provisions, a summary of the public comments received and our responses 
to them, and the policies we are finalizing for hospitals, HHAs, and 
CAHs. We have organized our proposed provisions and responses to the 
comments as follows: General comments; Discharge Planning Requirements 
of the IMPACT Act of 2014; Implementation; Prescription Drug Monitoring 
Programs; Patients' Rights and Discharge Planning in Hospitals; Home 
Health Agency Discharge Planning; and Critical Access Hospital 
Discharge Planning. Except for comments specific to the Hospital 
Innovation proposed rule, all comments discussed here were submitted in 
response to the Discharge Planning proposed rule. Comments related to 
the paperwork burden and impact analysis sections are addressed in 
section VI, ``Regulatory Impact Analysis'' of this final rule.

A. General Comments

    We received comments suggesting improvements to our regulatory 
approach or requesting clarification on general issues related to our 
proposed discharge planning requirements. The comments and our 
responses to those general comments are as follows.
    Comment: The majority of commenters generally supported 
standardizing and modernizing the discharge planning requirements for 
hospitals, including LTCHs and IRFs, HHAs, and CAHs. Individuals, 
including former patients, health care professionals, and advocacy 
groups strongly supported more stringent, detailed discharge planning 
requirements that focus on person-centered care and on the patient's 
treatment preferences and goals of care. Some of these commenters noted 
that without these requirements, some discharges from hospitals have 
been unsafe or inadequate and have led to readmissions or unnecessary 
emergency department visits shortly after discharge.
    However, most commenters disagreed with certain, specific proposed 
discharge planning requirements. Many of these commenters stated that 
the requirements were too burdensome or overly prescriptive. Some of 
these commenters found that the proposed requirements did not go far 
enough to protect patients. Finally, a few commenters were against new 
discharge planning requirements altogether.
    Response: We believe that these final discharge planning 
requirements for hospitals, including LTCHs, IRFs, HHAs, and CAHs will 
improve transitions of care, increase a patient's ability to access 
their health care information in a timely manner, and complement and 
align with efforts to improve interoperability across the care 
continuum. We also believe that these final requirements, which we 
discuss in further detail in subsequent sections of this final rule, 
are less burdensome than our initial proposed discharge planning 
requirements. In addition, we continue to believe in the importance of 
person-centered care during the discharge planning process. 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.
    These final requirements will establish and standardize discharge 
planning requirements for hospitals, HHAs, and CAHs. We note that 
effective discharge planning can also help to reduce patient 
readmissions, improve patient quality of care and outcomes, and reduce 
avoidable complications, adverse events, and readmissions.
    In addition, these regulations will implement the discharge 
planning requirements of the IMPACT Act, which will empower patients to 
be active participants in the discharge planning process, which will 
require providers to give patients more information as they choose a 
PAC provider. In regards to the commenters' concerns about specific 
proposed requirements, we refer readers to the specific provider 
sections and the specific provisions throughout the preamble of this 
final rule for a more detailed discussion of the final requirements and 
responses to the comments we received on the proposed rule.
    Comment: Several commenters requested clarification on whether the 
proposed requirements would apply to certain provider types or programs 
that are not mentioned in the proposed rule. A few commenters 
questioned whether the proposed discharge planning requirements would 
apply to inpatient psychiatric facilities, and one commenter asked 
whether the rule would apply to inpatient psychiatric units. The 
commenter recommended that CMS explicitly state which

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provider types would be required to comply with the discharge planning 
CoPs. One commenter requested clarification as to whether the proposed 
requirements would apply to partial hospitalization and intensive 
outpatient programs at hospitals.
    Response: All classifications of hospitals except CAHs are 
regulated under part 482 of our regulations, and are subject to the 
same set of hospital CoPs. We further clarified that the PAC providers 
mentioned in the IMPACT Act, specifically LTCHs and IRFs, would also be 
subject to the proposed revision to the hospital CoPs. We did not list 
all the classifications of hospitals in the proposed rule since we 
specifically focused on the PAC providers mentioned in the IMPACT Act, 
but we understand the importance of delineating which hospital types 
would have to comply with the hospital discharge planning CoPs, since 
they were not explicitly mentioned in the proposed rule. Therefore, we 
are clarifying that these final discharge planning requirements apply 
to all classifications of hospitals, including short-term acute care 
hospitals (including their IPPS-excluded rehabilitation or psychiatric 
units), psychiatric hospitals, LTCHs, rehabilitation hospitals, 
children's hospitals, and cancer hospitals. Throughout this final rule, 
we clarify that where the term ``hospital'' is used, we are referring 
to the aforementioned hospital classifications. These requirements 
would also apply to distinct part psychiatric and rehabilitation units 
in CAHs.
    Although these discharge planning requirements apply to psychiatric 
hospitals, there are several additional currently existing discharge 
planning requirements specific to psychiatric hospitals that are not 
affected by the discharge planning requirements discussed in this rule. 
Thus, psychiatric hospitals will still be required to meet the 
additional special provisions, special medical record requirements, and 
special staff requirements set out at Sec. Sec.  482.60, 482.61, and 
482.62.
    Inpatient psychiatric units located in a hospital, (as opposed to 
psychiatric hospitals) are specialized units within a larger hospital 
or CAH. Inpatient psychiatric units must meet the hospital CoP 
requirements for the hospitals in which they are located. However, they 
are not required to meet the CoPs specific to psychiatric hospitals set 
out at Sec. Sec.  482.60, 482.61, and 482.62. Therefore, these 
discharge planning requirements apply to inpatient psychiatric units 
located within a hospital or a CAH. The additional, currently existing, 
discharge planning requirements for psychiatric hospitals do not apply 
to inpatient psychiatric units. Note that ``inpatient psychiatric 
facility'' is a CMS classification used to refer to both psychiatric 
hospitals and inpatient psychiatric excluded units of hospitals and 
inpatient psychiatric distinct part units of CAHs; however, psychiatric 
excluded and distinct part units in hospitals and CAHs are not subject 
to the requirements under Sec. Sec.  482.60, 482.61, and 482.62.
    In response to the commenter's request for clarification regarding 
partial hospitalization services and intensive outpatient services at 
hospitals, we note that these services can be provided in a hospital 
outpatient department, and partial hospitalization services can be 
provided in a community mental health center. These discharge planning 
requirements however would not apply to services provided to patients 
in a community health center.
    Comment: Several commenters were concerned that durable medical 
equipment (DME) requirements were not specifically required in the 
discharge planning proposed rule. The commenters explained that 
providers should address and document a patient's DME needs during the 
discharge planning process. A few commenters also noted that DME was 
not addressed in the Meaningful Use Stage 3 requirements (80 FR 62761, 
which is discussed in our response here), and thus is still largely in 
paper format.
    Response: We agree that considering a patient's DME needs when 
planning for a patient's post-hospital care is a best practice. While 
we are not mandating that providers include information on a patient's 
DME needs in the patient's discharge instructions at this time, we 
encourage providers to do so where appropriate. However, comments 
regarding specific Stage 3 Meaningful Use requirements are not within 
the purview of these CoPs.
    Comment: One commenter noted the absence of proposed discharge 
planning requirements for SNFs in the Discharge Planning proposed rule. 
One commenter requested that CMS require nursing homes to provide 
patients with prescriptions before the patient returns home or back to 
the community. One commenter suggested that LTC facilities and 
rehabilitation facilities have a social worker with a Master of Science 
in Management (MSM), Licensed Clinical Social worker (LCSW), or a 
Master's degree in Gerontology. Another commenter recommended that each 
state expand the number of nursing facility/acute hospital Medicaid 
demonstration programs that will allow individuals with disabilities to 
live in the community.
    Response: Comments regarding LTC facilities and Medicaid 
demonstration programs are outside the scope of this final rule. The 
discharge planning requirements for SNFs were addressed in the Long-
Term Care (LTC) Facility Requirements final rule (81 FR 68688, October 
4, 2016) and Sec.  483.21(c) of the SNF requirements, which addresses 
discharge planning.
    Comment: A few commenters recommended that if CMS finalizes the 
proposed requirements, the final regulation and sub-regulatory guidance 
should not focus on the process of discharge planning alone, but allow 
providers greater flexibility to ensure their efforts are meaningful 
and adaptable over time. One commenter believed that the proposed rule 
included too many details on the discharge planning process instead of 
focusing on outcomes, which the commenter stated, could lead to 
``performing to the test'' activities that inhibit innovation. The 
commenter noted that the goals of the regulations should instead be 
focused on holding providers responsible for outcomes and not the 
processes of care. The commenter noted that CMS already has several 
programs that focus on outcomes, including value-based payment plans 
and hospital compare and star rating systems. The commenter ultimately 
believed that providers should use these mechanisms to drive innovation 
and lead to the best possible outcomes.
    Another commenter expressed concern over the potential impact of 
the proposed requirements on currently existing state innovation 
programs aimed at adopting value-based payment. The commenter 
recommended that CMS review the proposed changes to the CoPs, with 
support for state flexibility for innovation. Finally, another 
commenter noted that providers would need support in implementing and 
understanding the finalized discharge planning requirements.
    Response: We understand the commenters' concerns and have revised 
most of the proposed requirements in this final rule to focus less on 
prescriptive and burdensome process details, and more on patient 
outcomes and treatment preferences through the use of enhanced 
information exchange and innovative practice standards. We encourage 
hospitals, HHAs, and CAHs to actively engage with patients to create a 
more meaningful discharge planning process. We believe these 
requirements will afford patients the opportunity to

[[Page 51840]]

be active participants in the discharge planning process. In addition, 
in order to encourage patient engagement and understanding of their 
discharge plan or instructions, we recommend that providers follow the 
National Standards for Culturally and Linguistically Appropriate 
Services (CLAS) in Health and Health Care (https://www.thinkculturalhealth.hhs.gov/clas/standards), which provide guidance 
on providing instructions in a culturally and linguistically 
appropriate manner. We also remind providers of their obligations take 
reasonable steps to provide meaningful access to individuals with 
limited English proficiency in accordance with Title VI of the Civil 
Rights Act of 1964 and section 1557 of the Patient Protection and 
Affordable Care Act (the Affordable Care Act). In addition, providers 
are reminded to take appropriate steps to ensure effective 
communication with individuals with disabilities, including the 
provision of auxiliary aids and services, in accordance with section 
504 of the Rehabilitation Act, the Americans with Disabilities Act, and 
section 1557 of the Affordable Care Act (see, http://www.hhs.gov/civil-rights and http://www.ada.gov for more information on these 
requirements).
    We believe that the requirements, as revised here in this final 
rule, are consistent with the innovation goals of existing programs and 
initiatives, including the Hospital Value-Based Purchasing Program and 
the Center for Medicare and Medicaid Innovation's State Innovation 
Models Initiative.
    As with all CoPs, compliance with these requirements will be 
monitored by CMS, SAs, and AOs through surveys. We understand the 
commenter's concerns about provider support in implementing and 
understanding the final discharge planning requirements. We will 
provide sub-regulatory interpretive guidance after the publication of 
this final rule, which will provide further clarification for 
implementing the final discharge planning requirements.
    Comment: A few commenters requested changes to the terminology used 
throughout the proposed rule while others requested that CMS define 
certain terms used throughout the rule. One commenter requested that 
CMS use the term ``transition management'' instead of discharge 
planning.
    A few commenters recommended that CMS replace the term ``patient'' 
with ``individual,'' ``person'' or ``affected person,'' where 
appropriate, in order to further emphasize the expectation that the 
discharge planning process should be person-centered.
    A few commenters also had suggestions on the definition of 
``caregiver.'' One commenter recommended that the proposed rule define 
the term ``caregiver.'' The commenter noted that several terms are used 
throughout the proposed rule, including ``caregiver,'' ``caregiver/
support person,'' and ``family and/or caregiver.''
    Response: We agree that there are several different types of 
terminology providers may utilize when referring to some of the 
concepts used in this rule. We do not agree with changing the 
terminology currently used in this rule because we are using the most 
widely accepted and recognized terminology in the medical industry. In 
addition, the terminology used throughout this rule is used in the Act, 
including the term ``discharge planning process'' as set forth in 
section 1861(ee) of the Act.
    In addition, consistent with the language widely used by providers 
as well as the language used in the CoPs for hospitals, CAHs and HHAs, 
we continue the use of the term ``patient.'' As a result, we do not 
believe that it is appropriate to exclusively use ``person'' or 
``individual.'' However, we acknowledge that the use of ``person'' or 
``individual'' also appropriately refers to a patient, and we have used 
this terminology at various points in the rule (for example, when 
referring to person-centered care).
    In response to the commenter that requested a definition of 
``caregiver,'' we note that we often use the terms ``caregiver,'' 
``caregiver/support person,'' and ``family and/or caregiver,'' 
interchangeably, with the same intended meaning. We use these various 
terms in order to be consistent with the regulations that already exist 
for hospitals, HHAs, and CAHs. We do not believe that it is necessary 
to define the term, as it does not have a special meaning in this rule.
    Comment: Several comments were submitted related to the 
responsibilities of hospitals, HHAs, and CAHs to involve and 
communicate with caregivers. Commenters recommended the following:
     Require hospitals, HHAs, and CAHs to allow patients at 
least one opportunity to identify at least one caregiver/support person 
upon admission and prior to discharge or transfer to another facility, 
and to collect caregiver telephone contact and email address 
information when the provider offers the patient an opportunity to 
designate a caregiver.
     Clarify that providers must make reasonable attempts to 
contact the patient's identified caregiver during the discharge 
planning process.
     Require that, if the caregiver contacts the provider after 
the discharge planning process has begun, that individual must be 
involved in the discharge planning process.
     Require providers to ask what the preferred method of 
contact is for the caregiver.
     Require the provider to document all attempted contact 
with the caregiver.
     Clarify that caregivers and support persons should be 
involved, as applicable, but that CMS is not expecting that all 
patients will have caregivers and support persons and that the extent 
of the involvement of patients and caregivers be consistent with the 
patient's wishes and applicable law, including with the HIPAA Privacy 
Rule.
     Clarify expectations for how providers will address 
situations where a support person or caregiver is uncooperative, and 
how hospitals and CAHs should document the involvement of the caregiver 
and support person.
     Require that caregivers be notified in advance of the 
individual's discharge in order to ensure a safe and appropriate 
discharge back to the community.
     Provide caregivers with the name and contact information 
for the staff in the hospital or CAH, with whom they can discuss any 
concerns about the discharge plan or changes in the patient's care.
     Require providers to give the caregiver a copy of the 
final discharge plan, since ``informed of the final plan'' is not 
defined.
    Response: We appreciate the commenter's concerns regarding the 
inclusion of the patient's caregiver during the discharge planning 
process. We continue to strongly believe that a patient's caregiver 
should be included in the discharge planning process, and have revised 
the regulations at Sec.  482.43 for hospitals and Sec.  485.642 for 
CAHs to allow more flexibility for hospitals and CAHs in how such 
inclusion is achieved. We agree that we would not expect each patient 
to have a caregiver or support person, and that any level of caregiver 
involvement would be consistent with Sec.  164.510(b) of the HIPAA 
Privacy Rule as well as all other pertinent federal and state laws. We 
expect hospitals and CAHs to include the patient and the patient's 
caregiver/support person, where applicable, in the planning for a 
patient's post-discharge care. While it is beneficial for providers to 
obtain the contact information for a patient's designated caregiver, we 
disagree with the commenter's recommendation to mandate such a

[[Page 51841]]

requirement and believe that it would not be appropriate to require 
providers to make multiple attempts to contact caregivers during the 
discharge planning process. Such a requirement could prove to be 
burdensome to providers who are already compiling information for a 
discharge plan or discharge instructions and could potentially have the 
effect of hindering the discharge planning process. In addition, we do 
not believe that we should require hospitals to provide caregivers with 
the name and contact information for the staff at the hospital or CAH, 
as this may change over time. However, we note that as a best practice 
hospitals should give caregivers pertinent hospital contact 
information, so that caregiver can easily discuss concerns about the 
patient's discharge plan or instructions.
    While we are not requiring providers to give a copy of the 
discharge plan to caregivers, patients can request a copy of their 
medical record, including the discharge plan, from the hospital, in 
their requested form and format, as required by newly revised Sec.  
482.13(d)(2) (as discussed below), and the hospital must comply with 
the patient's access request as required by the HIPAA Privacy Rule at 
45 CFR 164.524. Similar requirements exist for HHAs and CAHs as well.
    Comment: Several commenters submitted specific comments about the 
sub-regulatory interpretive guidance. Commenters recommended that CMS 
engage pertinent stakeholders early in an open and transparent process 
for developing the interpretive guidance, surveyor training, and 
provider education, and also implement a lean process improvement 
strategy.
    Response: As with all regulations regarding the CoPs, the 
interpretive guidance will be updated once this final rule is 
published. The development of the interpretive guidance is a sub-
regulatory process and is not required to be circulated for public 
comment. Comments regarding the process for developing the interpretive 
guidance and state survey and certification procedures are outside the 
scope of this final rule.
    Comment: One commenter requested an extension to the 60-day comment 
period. Another commenter stated that the comment period was adequate.
    Response: We believe that the 60-day comment period was sufficient, 
as evidenced by the number of comments we received. The comment period 
closed on January 4, 2016 for the Discharge Planning proposed rule, and 
on August 15, 2016 for the Hospital Innovation proposed rule.
    Comment: A few commenters asked for clarification regarding 
provider reimbursement.
    Response: Comments related to provider reimbursement are outside 
the scope of this final rule.
    Comment: One commenter recommended that a patient's written notice 
of beneficiary's rights as an inpatient include a description of the 
patient's discharge rights. They also recommended that providers be 
required to provide patients with a discharge planning fact sheet. 
Another commenter recommended adding an additional section for 
hospitals, HHAs, and CAHs that would require these providers to advise 
patients of their rights to appeal a discharge or complain about the 
quality of care and advise the patient of the availability of 
assistance from Beneficiary and Family Centered Care Organizations. The 
commenters suggested referring to several CMS links regarding hospital 
appeals.
    Response: The policies regarding a beneficiary's rights as an 
inpatient are outside the scope of this final rule. We continue to 
require providers to include patients and their caregiver/support 
persons in the discharge planning process. Additionally, the 
requirement at Sec.  482.13(a)(2), under the Patient's Rights CoP for 
hospitals, requires the hospital to establish a process for prompt 
resolution of patient grievances and must inform each patient whom to 
contact to file a grievance. Outside of the CoPs, other specific CMS 
requirements regarding the Medicare beneficiary appeals process may 
apply.
    Comment: We received a large number of similar comments from 
individuals regarding patient nutrition and food security needs. 
Commenters recommended that the discharge planning requirements include 
a nutritional component and that specific language regarding food and 
nutritional services during the discharge planning process be included 
in the regulations.
    Response: While we agree that a patient's nutrition and food 
security needs may impact care after discharge, we do not agree that 
including specific language regarding food and nutritional services 
during the discharge planning process is necessary for all patients as 
a minimum discharge planning requirement. We believe that mandating 
such additional requirements would be burdensome. However, we encourage 
providers to consider and address any patient food and drug 
interactions, as well as the patient's nutritional needs, as part of 
the necessary medical information that must go along with the patient 
as part of the discharge plan and which we are finalizing in this rule.
    Comment: A few commenters offered recommendations regarding the use 
of certified health IT, EHRs, and ``meaningful use'' as described in 
our regulations at 42 CFR 495.22, and finalized in the FY 2018 IPPS/
LTCH PPS final rule (82 FR 37990, 38517). Some commenters focused on 
the development of a modular certification program for long-term and 
PAC providers, who were not eligible for meaningful use incentives 
under Medicare or Medicaid as authorized by the Health Information 
Technology for Economic and Clinical Health Act (HITECH Act). 
Additionally, commenters urged CMS and ONC to consider ways to 
encourage the adoption and use of these tools by rural and frontier 
providers to prevent a digital gap.
    Another commenter recommended that the requirements in this rule 
align with current health IT certification requirements, in order to 
eliminate redundancy.
    One commenter suggested that CMS require facilities that are 
electronically capturing information to do so using certified health 
IT.
    Response: We did not propose the required use of certified health 
IT for health care providers under the CoPs. We also did not propose 
that providers use a specific form, format, or methodology for the 
communication of patient health care information. Therefore, these 
comments are out of scope of this rule. However, 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 and with patients. We 
also believe that health IT should be interoperable and that 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. 
Furthermore, we believe that facilities that are electronically 
capturing information should be exchanging that information 
electronically with providers who have the capacity to accept it.
    CMS is firmly committed to the use of certified health IT and 
interoperable EHR systems for electronic healthcare information 
exchange to effectively help hospitals and other Medicare- and 
Medicaid-participating providers and suppliers improve internal care 
delivery practices, support the exchange of important information 
across care team members during transitions of care, and enable 
reporting of electronically

[[Page 51842]]

specified clinical quality measures (eCQMs). In addition, to further 
interoperability in post-acute care, CMS has launched the Data Element 
Library (DEL), which serves as a publicly available centralized, 
authoritative resource for standardized data elements and their 
associated mappings to health IT standards. The DEL furthers CMS' goal 
of data standardization and interoperability, which is also a goal of 
the IMPACT Act. These interoperable data elements can reduce provider 
burden by allowing the use and exchange of healthcare data, support 
provider exchange of electronic health information for care 
coordination, person-centered care, and support real-time, data driven, 
clinical decision making. Standards in the Data Element Library 
(https://del.cms.gov/) can be referenced on the CMS website and in the 
ONC Interoperability Standards Advisory (ISA). The 2019 
Interoperability Standards Advisory (ISA) is available at https://protect2.fireeye.com/url?k=44af3763-18fa3e70-44af065c-0cc47adb5650-601d6acb74373f82&u=https://www.healthit.gov/isa.
    We note that we work in conjunction with the Office of the National 
Coordinator for Health Information Technology (ONC), which acts as the 
principal federal entity charged with coordination of nationwide 
efforts to implement and use health information technology and the 
electronic exchange of health information on behalf of HHS, to promote 
these goals. As previously noted, ONC finalized the 2015 Edition final 
rule, which sets out the current criteria for health IT to be certified 
under the ONC Health IT Certification Program. The 2015 Edition final 
rule facilitates greater interoperability for several clinical health 
information purposes and enables health information exchange through 
new and enhanced certification criteria, standards, and implementation 
specifications. We note that CMS requires eligible hospitals and CAHs 
in the Medicare and Medicaid Promoting Interoperability Programs 
(previously known as the EHR Incentive Programs) and eligible 
clinicians in the Quality Payment Program (QPP) to use EHR technology 
certified to 2015 Edition health IT certification criteria beginning in 
CY 2019 (42 CFR 414.1305, 495.4, (81 FR 77538, 77555)). The 2015 
Edition also defines a core set of data that health care providers have 
noted is critical to interoperable exchange and can be exchanged across 
a wide variety of other settings and use cases, known as the Common 
Clinical Data Set (C-CDS) (80 FR 62608 through 62702).
    In an effort to continue to support seamless and secure access, 
exchange, and use of electronic health information, ONC published a 
proposed rule on March 4, 2019 in the Federal Register, titled ``21st 
Century Cures Act: Interoperability, Information Blocking, and the ONC 
Health IT Certification Program'' (84 FR 7424), which would implement 
certain provisions of the 21st Century Cures Act (the Cures Act) (Pub. 
L. 114-255), including conditions and maintenance of certification 
requirements for health information technology (health IT) developers 
under the ONC Health IT Certification Program (Program), the voluntary 
certification of health IT for use by pediatric health care providers, 
and reasonable and necessary activities that do not constitute 
information blocking.
    The proposed rule would also modify the 2015 Edition health IT 
certification criteria and Program in additional ways to advance 
interoperability, enhance health IT certification, and reduce burden 
and costs. Specifically, the proposed rule builds on the Common 
Clinical Data Set with the U.S. Core Data for Interoperability (Version 
1) (USCDI). The USCDI aims to support the goals set forth in the Cures 
Act by specifying a common set of data classes that will be required 
for interoperable exchange, and identifying a predictable, transparent, 
and collaborative process for achieving those goals (https://www.healthit.gov/isa/us-core-data-interoperability-uscdi).
    Section 4003 of the Cures Act, enacted in 2016, and amending 
section 3001 of the Public Health Service Act (42 U.S.C. 300jj-11(c)), 
requires HHS to take steps to advance the electronic exchange of health 
information and interoperability for participating providers and 
suppliers in various settings across the care continuum. Specifically, 
Congress directed that ONC ``. . . for the purpose of ensuring full 
network-to-network exchange of health information, convene public-
private and public-public partnerships to build consensus and develop 
or support a trusted exchange framework, including a common agreement 
among health information networks nationally.'' A trusted exchange 
framework can allow for the secure exchange of electronic health 
information with, and use of electronic health information from other 
health IT without special effort on the part of the user. Trusted 
exchange networks allow for broader interoperability beyond one health 
system or point to point connections among payers, patients, and 
providers. Such networks establish rules of the road for 
interoperability, and with maturing technology, such networks are 
scaling interoperability and gathering momentum with participants, 
including several federal agencies, EHR vendors, retail pharmacy 
chains, large provider associations, and others.
    In light of the widespread adoption of EHRs, along with the 
increasing availability of health information exchange infrastructure 
predominantly among hospitals, we solicited public comments on how we 
could use the CMS health and safety standards that are required for 
providers and suppliers participating in the Medicare and Medicaid 
programs (that is, the CoPs, the CfCs, and the requirements for Long 
Term Care (LTC) Facilities) to further advance electronic exchange of 
information that supports safe, effective transitions of care between 
hospitals and community providers in the Request for Information 
published in our payment rules in 2018 in the Federal Register, titled 
``Request for Information on Promoting Interoperability and Electronic 
Healthcare Information Exchange through Possible Revisions to the CMS 
Patient Health and Safety Requirements for Hospitals and Other 
Medicare- and Medicaid-Participating Providers and Suppliers''. 
Specifically, we noted that CMS will consider revisions to the current 
CMS CoPs for hospitals such as: Requiring that hospitals transferring 
medically necessary information to another facility upon a patient 
transfer or discharge do so electronically; requiring that hospitals 
electronically send required discharge information to a community 
provider via electronic means, if possible and if a community provider 
can be identified; and requiring that hospitals make certain 
information available to patients or a specified third-party 
application (for example, required discharge instructions) via 
electronic means if requested.
    To fully understand all of these health IT interoperability issues, 
initiatives, and innovations through the lens of its regulatory 
authority, we invited members of the public to submit their ideas on 
how best to accomplish the goal of fully interoperable health IT and 
EHR systems for Medicare- and Medicaid-participating providers and 
suppliers, as well as how best to further contribute to and advance the 
MyHealthEData initiative for patients. We were particularly interested 
in identifying fundamental barriers to interoperability and health 
information exchange, including those specific barriers that prevent 
patients from being

[[Page 51843]]

able to access and control their medical records. We also welcomed the 
public's ideas and innovative thoughts on addressing these barriers and 
ultimately removing or reducing them in an effective way, and how 
revisions to the current CMS CoPs, CfCs, and RfPs for hospitals and 
other participating providers and suppliers could play a role in 
addressing these barriers. We refer readers to the specific Request for 
Information sections in the following 2019 payment rules:
     FY 2019 Inpatient Prospective Payment System/Long Term 
Care Hospital Prospective Payment System Proposed Rule (83 FR 20550 
through 20553);
     FY 2019 Inpatient Rehabilitation Facility Prospective 
Payment System Proposed Rule (83 FR 21004 through 21007);
     FY 2019 Hospice Wage Index and Payment Rate Update and 
Hospice Quality Reporting Requirements Proposed Rule (83 FR 20963 
through 20966);
     FY 2019 Inpatient Psychiatric Facilities Prospective 
Payment System and Quality Reporting Updates Proposed Rule (83 FR 21135 
through 21138);
     FY 2019 Prospective Payment System and Consolidated 
Billing for Skilled Nursing Facilities (SNF) Proposed Rule (83 FR 21089 
through 21092);
     CY 2019 Home Health Proposed Rule (83 FR 32471 through 
32473);
     CY 2019 End-Stage Renal Disease Prospective Payment System 
Proposed Rule (83 FR 34391 through 34394);
     CY 2019 Physician Fee Schedule Proposed Rule (83 FR 36006 
through 36009); and
     CY 2019 Outpatient Prospective Payment System/Ambulatory 
Surgical Center Proposed Rule (83 FR 37209 through 37211).
    We note that the comments we received on this Request for 
Information will be reviewed for informational purposes as we consider 
new or revised CoPs/CfCs/requirements for interoperability and 
electronic exchange of health information in future rulemaking.
    Additionally, CMS published a proposed rule, which, if finalized as 
proposed, would improve interoperability and outline opportunities to 
make patient data more useful and transferable through open, secure, 
standardized, and machine-readable formats while reducing restrictive 
burdens on healthcare providers (84 FR 7610). Specifically, the 
proposed rule would revise the CoPs by requiring a hospital, 
psychiatric hospital, or CAH, which utilizes an EHR system with the 
capacity to generate information for patient event notifications (based 
on admission, discharge, and transfer (ADT) messages,) to demonstrate 
that its system's notification capacity is fully operational, is 
operating in accordance with all state and federal statutes and 
regulations regarding the exchange of patient health information, and 
utilizes a specified content exchange standard. Such patient event 
notifications would be required to include defined minimum patient 
health information, which were proposed to include the minimum patient 
health information (which must be patient name, treating practitioner 
name, sending institution name, and, if not prohibited by other 
applicable law, patient diagnosis). Such messaging could be done 
directly, or through an intermediary that facilitates exchange of 
health information, and would occur at the time of admission and 
immediately prior to or at the time of discharge or transfer. And, in 
recognition of factors outside of a facility's control that may 
determine whether or not a notification can be successfully 
transmitted, an applicable hospital (as well as an applicable 
psychiatric hospital or CAH) would only be required to send ADT 
messages to licensed and qualified practitioners, other patient care 
team members and PAC services providers and suppliers (1) that receive 
the notification for treatment, care coordination, or quality 
improvement purposes; (2) that have an established care relationship 
with the patient relevant to his or her care; and (3) for whom the 
hospital (or psychiatric hospital or CAH) has a reasonable certainty of 
receipt of notifications.
    Comment: One commenter stated that we should develop consistent 
standards of communication, information sharing, and discharge planning 
across the entire acute and post-acute care continuum. The commenter 
states that this consistency will facilitate standardization of the 
information collected and definitions used to improve the process, 
enhance communication, and ensure everyone is working toward the same 
goals.
    Response: We agree that standardized methods of communication can 
be helpful to encourage consistency regarding compliance with this 
requirement. With regards to EHRs, we note that as of 2015, nearly all 
(96 percent) of non-federal acute care hospitals reported possessing a 
certified EHR system. Substantial adoption of certified health IT among 
hospitals is an important factor in moving the health care system 
towards common standards for sharing data. (ONC/American Hospital 
Association (AHA), AHA Annual Survey Information Technology Supplement 
(http://dashboard.healthit.gov/evaluations/data-briefs/non-federal-acute-care-hospital-ehr-adoption-2008-2015.php.). We further believe 
that facilities, which are electronically capturing patient health care 
information, should be sharing that information electronically with 
health care providers that have the capacity to receive it to the 
extent they are authorized to do so.
    Aside from the certification of EHR technology that was finalized 
in other rules, we did not propose standardized methods of 
communication and information sharing between different health care 
provider types as part of the Conditions of Participation.
    Comment: A few commenters suggested adding pharmacists and 
occupational therapists to the discharge planning team. Another 
commenter suggested that we require hospitals, CAHs, and HHAs to 
consult with a ``conflict-free community care coordinator'' in 
developing the discharge plan and in identifying a list of HHAs, SNFs, 
IRFs, or LTCHs that are available to provide post-acute care.
    Response: Our use of the broad term ``practitioner'' encompasses 
all practitioners, including non-physician practitioners, which may be 
operating within a hospital. Providers may utilize the appropriate 
practitioners that they believe will effectively conduct a patient's 
discharge planning process. For those reasons, the discharge planning 
CoPs do not include requirements specific to individual practitioner 
categories. The regulations text, as written, does not explicitly state 
who must provide the list of PAC providers to the patient or their 
representative. In addition, the regulation text does not prohibit 
hospitals from including any qualified personnel it chooses in this 
part of the discharge planning process. Typically, the list of PAC 
providers is given to patients or their representative by a social 
worker or registered nurse (who is a case manager). The hospital must 
identify in its discharge planning policy the qualified personnel who 
will be involved in the discharge planning process and must execute 
their discharge planning process in accordance with their policies.
    We appreciate the suggestion that providers utilize a conflict-free 
advisor. However, we believe that provider staff are capable of 
complying with the requirement to assist patients and their caregivers 
in selecting a post-acute care provider by using and sharing data that

[[Page 51844]]

includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality 
measures and data on resource use measures. The utilization of 
contracted entities to perform this service would be a business 
decision of the provider, and it is not necessary to compel such 
business relationships via a regulatory requirement.
    Comment: One commenter recommended that the discharge planning 
regulations be reviewed and updated more frequently.
    Response: Although we frequently assess the need to update the 
CoPs, section 2(a) of the IMPACT Act, adding subsection 1899B(i) to the 
Act, requires us to update the CoPs and subsequent interpretive 
guidance for hospitals, CAHs, and PAC providers periodically, but not 
less frequently than once every 5 years.

B. Discharge Planning Requirements of the IMPACT Act of 2014 (Proposed 
Sec.  482.43(c)(8), Proposed Sec.  484.58(a)(6), and Proposed Sec.  
485.642(c)(8))

    We proposed at Sec.  482.43(c)(8), to require that hospitals assist 
patients, their families, or their caregivers/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 also proposed requirements for HHAs in accordance with the 
requirements of the IMPACT Act. For those patients who are transferred 
to another HHA or who are discharged to a SNF, IRF, or LTCH, we 
proposed at Sec.  484.58(a)(6) 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.
    As required by the IMPACT Act, HHAs must take into account data on 
quality measures and resource use measures during the discharge 
planning process. We also proposed at Sec.  484.58(a)(6) 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. We received many public comments on these 
proposed requirements for HHAs and we refer readers to section II.C.4 
of this final rule for a summary of those comments and our responses.
    Finally, for CAHs, we proposed 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 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.
    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 be required 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, we expect that CAHs 
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. CAHs 
could also 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.
    Comment: While many commenters supported the IMPACT Act's goals to 
standardize data amongst PAC providers, most commenters requested 
clarification on the specifics of the proposed IMPACT Act discharge 
planning requirements for hospitals, HHAs, and CAHs. Most commenters 
asked CMS to clarify what data sources hospitals would be expected to 
use and where these data sources would be available. One commenter 
recommended that hospitals not assist patients in selecting a PAC 
provider or making decisions about the patient's post-acute needs, and 
instead require that access to these data be made available to patients 
and their families. A few commenters questioned the use of the Nursing 
Home Compare and Home Health Compare websites. These commenters were 
concerned that patients may receive inaccurate or outdated information. 
One of these commenters recommended that CMS provide a publicly 
available database of certified providers. One commenter stated that 
CMS's ``Compare'' websites can be confusing for patients and would 
likely require case management professionals to filter and interpret 
the data. The commenter further stated that additional studies would 
need to be conducted on how to disseminate this data in a manner that 
is easily understood and meets CLAS standards. The commenter therefore 
recommended that CMS provide standard, publicly-available data 
visualization and interpretation standards or guides. Additionally, 
another commenter recommended that CMS develop a patient resource to 
assist with the interpretation of the quality and resource use data. 
Another commenter noted that while quality data is available through 
the Nursing Home and Home Health Compares, similar websites do not 
exist for other PAC providers, such as IRFs.
    Several commenters questioned whether relevant hospital 
practitioners were qualified to interpret, discuss, and answer 
questions about the quality and resource use data. A few commenters 
recommended that CMS give providers more information and guidelines on 
how to discuss PAC data on quality measures and data on resource use 
measures with patients. In particular, the commenters stated that CMS 
should provide concise, consumer-friendly information on each measure 
and how to evaluate the performance of a specific measure to determine 
whether a certain provider is appropriate for a patient. Another 
commenter asked that the final rule acknowledge that it may not be 
feasible for a hospital to provide complex quality data for each PAC 
facility that is being considered with the expectation that the 
hospital explain all of the nuances that account for different ratings.
    Response: Section 1899B(i) of the Act requires that PAC providers, 
hospitals and CAHs take into account quality, resource use, and other 
measures in the

[[Page 51845]]

discharge planning process. We understand that commenters had concerns 
about using appropriate data that would be comparable to the data that 
would be gathered and provided in accordance with the requirements of 
the IMPACT Act. However we note that since the publication of the 
proposed rule in 2015, the measures we implemented into the PAC Quality 
Reporting Program (QRPs) for the domains of functional status, skin 
integrity, the incidence of major falls, and the resource use and other 
measures as required by the Act are now publicly available on the IRF, 
SNF, LTCH, and Home Health (HH) Compare websites. Data from these 
measures are now being reported to providers by means of private 
provider feedback reports. Other data as required by the IMPACT Act 
will be publicly available in the near future. We therefore expect 
providers to make reasonable efforts to use the quality and resource 
use measure data that are currently available to them until all of the 
measures stipulated in the IMPACT Act are finalized and publicly 
reported. Additional explanations, resources, instructions, and help on 
how to use the IRF Compare, HH Compare, Nursing Home Compare, and Long-
Term Care Hospital Compare websites are currently available on the 
following pertinent websites:
     https://www.medicare.gov/inpatientrehabilitationfacilitycompare/.
     https://www.medicare.gov/homehealthcompare/search.html.
     https://www.medicare.gov/nursinghomecompare/search.html.
     https://www.medicare.gov/longtermcarehospitalcompare/.
    While the data from these sources are not available in ``real 
time,'' the data are posted as soon as feasible. Providers should use 
these data sources to assist patients as they choose a PAC provider 
that aligns with the patient's goals of care and treatment preferences, 
and we would also expect providers to document all efforts regarding 
this requirement in the patient's medical record.
    We believe that providers have the ability and knowledge to 
interpret and discuss the publicly available data on quality and 
resource use measures at the most basic levels. We note that we do not 
expect providers to give overly detailed and complex analyses of the 
quality and resource use data, which may only serve to confuse patients 
and/or their caregivers, nor do we expect providers to attempt to 
provide patients and their caregivers with data that do not exist 
regarding PAC facilities. We expect providers to put forth their best 
effort to answer patient questions regarding the data. We also 
encourage providers to refer to www.medicare.gov for additional 
resources and help. Further information regarding specific measures 
mandated by the IMPACT Act will be available in forthcoming 
regulations. Finally, we also encourage providers to consult the sub-
regulatory interpretive guidance that will be available after 
publication of the final rule.
    Comment: Several commenters asked for clarification on what 
additional information can be provided to patients about PAC providers. 
A few commenters gave examples of marketing materials, other 
information the provider may have regarding a PAC's quality and 
resource use, whether the patient's health insurance covers the 
patient's specific PAC provider choice, and information regarding out 
of pocket cost for PAC providers.
    Response: Providers can use additional available information to 
assist patients as they select a PAC provider, so long as the 
information presented aligns with the patient's goals of care and 
treatment preferences. The IMPACT Act in no way limits providers' 
ability to augment the information provided to patients. All attempts 
to assist patients should be documented in the medical record.
    Furthermore, these discharge planning requirements do not prohibit 
providers from giving patients information regarding coverage of a 
selected PAC by the patient's insurance or specifics on out of pocket 
costs for PAC providers. Providers may give this information to 
patients if they choose. However, we do not expect providers to have 
definitive knowledge of the terms of a patient's insurance coverage or 
eligibility for post-acute care, or for Medicaid coverage, but we 
encourage providers to be generally aware of the patient's insurance 
status. We do not believe that it is appropriate to mandate such a 
requirement here, as these CoPs provide basic requirements for the 
discharge planning process.
    Comment: Several commenters asked for clarification on how 
providers can assist patients in choosing a PAC provider without 
improperly steering the patient to certain providers. Some commenters 
expressed concern that the proposed requirements may lead to hospital 
steering, with some commenters expressing concern that certain 
hospitals may employ tactics to purposely channel patients to other 
providers or suppliers within their medical system or under common 
ownership. A few commenters questioned whether patient choice would be 
influenced by the patient receiving services or care from a Medicare 
fee-for-service provider who may be participating in an alternative 
payment model, such as bundled payment programs, shared savings 
programs, or full clinical and financial risk payment programs.
    Commenters expressed their belief that CMS should allow providers 
to identify the best PAC providers that lead to improved efficiency and 
better outcomes, so long as patients are given the ultimate choice of 
PAC provider and all financial dealings and conflicts of interest are 
disclosed to the patient during the discharge planning process.
    Response: We understand the commenter's concerns regarding patient 
steering. However, we believe compliance with the revised CoP and the 
fraud and abuse laws, including the physician self-referral law and 
Federal anti-kickback statute, is achievable. We believe that 
hospitals, HHAs and CAHs will be in compliance with this requirement if 
they present objective data on quality and resource use measures 
specifically applicable to the patient's goals of care and treatment 
preferences, taking care to include data on all available PAC 
providers, and allowing patients and/or their caregivers the freedom to 
select a PAC provider of their choice. Providers will have to document 
all such interactions in the medical record. In addition, we expect 
hospitals to comply with the requirements in Sec.  482.43(c) and inform 
the patient and/or the patient's representative of their freedom to 
choose among participating Medicare providers and suppliers of post-
discharge services, while not specifying or otherwise limiting the 
qualified providers or suppliers that are available to the patient. 
Hospitals, HHAs, and CAHs that have concerns that providing objective 
information in these circumstances may conflict with other laws can 
obtain guidance on the physician self-referral law at www.cms.gov/physicianselfreferral and on the Federal anti-kickback statute at 
www.oig.hhs.gov. Information about obtaining advisory opinions 
regarding the application of the physician self-referral law in 
specific circumstances can be found at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/advisory_opinions.html and 
regarding the application of the anti-kickback law at https://oig.hhs.gov/compliance/advisory-opinions/index.asp.
    We remind providers that compliance with these requirements will be 
assessed through on-site surveys by CMS, state survey agencies, and AOs 
and that purposeful patient steering

[[Page 51846]]

(that is, directing patients and/or their caregivers to PAC providers 
that do not align with the patient's goals of care and treatment 
preferences) could lead to a determination of provider noncompliance 
with the requirements in this rule. We also note that physician self-
referral violations may result in imposition of penalties set out under 
section 1877(g) of the Act.
    Comment: One commenter questioned the guidance on resource use 
measures in the proposed rule with regards to dementia patients. The 
commenter stated that data on discharge to the community and data on 
preventable readmission rates for persons with dementia is limited. The 
commenter further stated that CMS could collect data on how many all-
cause readmission beneficiaries have dementia.
    Response: Providers must use and share data on quality measures and 
data on resource use measures that are relevant and applicable to the 
patient's goals of care and treatment preferences. While we believe 
that resource use data can be helpful to all patients, providers can 
tailor the specific data that are given to patients so that the data 
are applicable to the patient's specific medical condition or 
circumstance. The provider should ensure that the data given to 
patients aligns with the patient's ultimate goals of care and treatment 
preferences.
    The comments regarding the collection of quality measures are 
outside the scope of this final rule. However, we do appreciate the 
commenter's suggestion regarding data that pertain to patients with 
dementia.
    Comment: One commenter asked that CMS clarify the protocols that 
providers would be expected to follow if a patient refused to agree to 
be discharged to a PAC facility chosen on the basis of the supplied 
quality data and/or family preferences, especially when no other safe 
options existed in the area.
    Response: We expect hospitals, HHAs, and CAHs to document the 
patient's refusal in the medical records and continue to make 
reasonable efforts to work with the patient and/or the patient's 
caregiver to find appropriate substitutions. However, we note that 
Medicare and Medicaid participating facilities are surveyed regularly 
to assure quality, and we believe that Medicare facilities in good 
standing can be trusted to provide services safely.
    Final Decision: After consideration of the comments we received on 
the Discharge Planning proposed rule, we are finalizing and 
redesignating the proposed requirements at Sec. Sec.  482.43(c)(8) and 
485.642(c)(8) as Sec. Sec.  482.43(a)(8) and 485.642(a)(8), 
respectively, without modification. We are finalizing and redesignating 
the requirements in proposed Sec.  484.58(a)(6) as Sec.  484.58(a), 
without modification.

C. Implementation

    We solicited comments on the timeline for implementation of the 
discharge planning requirements for HHAs and CAHs. We received many 
comments in response to this solicitation for comments and 
recommendations on the effective date and the date of implementation of 
the discharge planning requirements in hospitals.
    Comment: Many commenters recommended a delay in the implementation 
or the effective date of the final discharge planning requirements for 
all providers. Most of these commenters noted that the proposed 
discharge planning requirements were extensive and that hospitals, 
HHAs, and CAHs would need additional time to understand and fully 
implement all the requirements, train staff, and update EHR systems to 
reflect the final discharge planning requirements. Recommendations for 
implementation timeframes or delays in the effective date included:
     1 to 5 years, with several commenters specifically 
recommending a 1-year delay;
     Piloting discharge planning requirements before finalizing 
them;
     Phasing in the requirements; and
     A 2-year delay with implementation to begin with 
inpatients that hospitals determine are most at risk for readmission.
    Many commenters were particularly concerned about the effective 
date for certain specific proposed requirements. Most suggested 
delaying the effective date for the discharge planning requirements of 
the IMPACT Act until quality reporting data is publicly available.
    Response: We continue to believe that most hospitals and CAHs have 
discharge planning processes in place and that these providers will be 
well prepared to implement the final discharge planning requirements. 
In addition, we are either revising or not finalizing most of our 
proposed discharge planning requirements, such as the design, 
applicability, and timeframe requirements for hospitals and CAHs, which 
will reduce additional burden. Therefore, we do not believe an 
additional delay in the effective date for hospitals and CAHs is 
necessary. In light of the significant streamlining of the final 
discharge planning requirements for HHAs, we do not believe an 
additional delay in the effective date for implementation of the final 
discharge planning requirements for HHAs, including the Impact Act 
requirements at Sec.  484.58(a) are necessary. We also believe the 
discharge planning requirements in this final rule are beneficial to 
patients and their caregivers (where applicable) and will reduce 
patient readmission risks and improve patient care. We refer readers to 
the provider-specific sections II.C through II.E of this final rule, 
for a summary of the public comments we received, our responses to the 
comments, and the final requirements and to section II.B of this final 
rule for a discussion of the discharge planning requirements of the 
IMPACT Act and the measures that are currently publicly available.
    Final Decision: After consideration of the comments received, we 
are requiring implementation of the final requirements for HHAs 60 days 
after date of publication of this final rule, including the IMPACT Act 
requirements at Sec.  484.58(a). Hospitals and CAHs will be required to 
comply with all of the final requirements 60 days after date of 
publication of this final rule.

D. Prescription Drug Monitoring Programs (PDMPs)

    In the Discharge Planning proposed rule, we encouraged providers to 
consider using their state's Prescription Drug Monitoring Program 
(PDMP) during the evaluation of a patient's relevant co-morbidities and 
past medical and surgical history (80 FR 68132). Given the potential 
benefits of PDMPs as well as some of the challenges noted in the 
proposed rule, we solicited 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. We also solicited comments on the use 
of PDMPs in the medication reconciliation process.
    Comment: We received a large number of comments in response to our 
solicitation for comments on the use of PDMPs during the discharge 
planning process. A majority of commenters strongly disagreed with 
establishing a requirement for providers to consult with their state's 
PDMP, with most stating that such a requirement would be burdensome and 
time consuming for providers and their prescribing practitioners during 
the discharge planning process. A few commenters expressed specific 
concerns about the burden of such a requirement on CAH providers. One 
commenter expressed

[[Page 51847]]

concern about the applicability of this requirement to pediatric 
patients and recommended that this requirement be optional for 
pediatric patients under the age of 12. Many commenters agreed that 
PDMPs could potentially be useful, if the many challenges that 
currently exist within the PDMP systems are resolved. In addition, some 
commenters stated that PDMPs could work if there were a national or 
standardized PMDP database. In addition, one commenter requested 
clarification on how CMS expects providers to use PDMPs.
    Several commenters agreed that many PDMPs still encounter legal, 
policy, and technical challenges. Many of these commenters raised 
issues of interoperability and noted that access to PDMPs varies widely 
by state and that data contained within their individual state's PDMP 
is often incomplete or out of date or provides limited access or access 
that is slow. Some commenters explained that there are additional 
challenges for providers whose patients cross multiple state lines, 
since PDMPs vary by state. One commenter questioned whether these 
hospitals would be required to check all state databases that are in 
their surrounding area.
    Some commenters noted that their state did not have a PDMP. Other 
commenters noted that the proposed requirement would conflict with some 
state laws and requirements. These commenters indicated that state PDMP 
statutes were not enacted to assist discharge planning. A few 
commenters recommended deferring to the local state requirements while 
others specified the importance of addressing restrictions under the 
HIPAA Privacy Rule at Sec.  164.510. A few commenters gave the example 
of Ohio as a state with a mandatory PDMP requirement. Ohio currently 
requires prescribing physicians and other prescribing practitioners to 
check the Ohio Automated Rx Reporting System (OARRS). One commenter 
recommended that CMS work with state PDMP programs to facilitate 
proactive PDMP report generation that could be sent to hospitals at the 
time of patient admission.
    Some commenters stated that HHAs in their state do not have access 
to their state's PDMP system; and that only pharmacists, prescribers, 
and law enforcement officials have access to the system. Other 
commenters noted that HHAs do not prescribe controlled substances or 
other types of medications.
    A few commenters agreed with requiring providers to use PDMPs. Some 
other commenters supported CMS' continued encouragement of the use of 
PDMPs, but encouraged CMS not to mandate the use of PDMPs. One 
commenter stated that a mandatory requirement should not be instituted 
for providers; instead, each facility should be able to determine 
whether use of the PDMP is appropriate or necessary on an individual 
patient level. One commenter stated that PDMPs should only apply to the 
prescription of controlled substances until the universal use of PDMPs 
is better understood.
    Response: We thank the commenters for their feedback. We received 
many comments that stated that we had proposed PDMP requirements for 
providers and many of these comments recommended that we not finalize, 
or delay finalization, of this proposal. However, we clarify that we 
did not propose PDMP requirements, and solely solicited comments in the 
proposed rule on whether provider consultations with PDMPs during the 
discharge planning process should be required.
    Final Decision: After taking into consideration the comments 
received in response to our solicitation of comments for PDMPs, we 
agree that it would be difficult to implement a mandatory requirement 
for providers to access their state's PDMP during the discharge 
planning process at this time. We appreciate stakeholder input on this 
issue. We will not require that hospitals, including LTCHs and IRFs, 
HHAs or CAHs 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, nor will we require 
providers to use or access PDMPs during the medication reconciliation 
process. However, as discussed in the proposed rule, we strongly 
encourage practitioners to utilize strategies and tools, such as PDMPs, 
to the extent permissible under the HIPAA Privacy Rule and state law, 
to help to reduce prescription drug misuse. Furthermore, we note that 
there may be state laws that require practitioners to consult with 
their state's PDMP system and we acknowledge that since the publication 
of the proposed rule, additional states have adopted statewide PDMP 
programs. We therefore remind providers that they must continue to 
abide by all applicable state laws.

E. Patients' Rights and Discharge Planning in Hospitals

1. Patient's Access to Medical Records (Proposed Sec.  482.13(d)(2))
    In the Hospital Innovation proposed rule, we proposed clarifying 
the requirement for hospitals at Sec.  482.13(d)(2) to state that the 
patient has the right to access their medical records, including 
current medical records, upon an oral or written request, in the form 
and format requested by the individual, if it is readily producible in 
such form and format (including in an electronic form or format when 
such medical records are maintained electronically); or, if not, in a 
readable hard copy form or such other form and format as agreed to by 
the facility and the individual, within a reasonable time frame (81 FR 
39475). We also note that our use of terms ``patients'' and ``medical 
records'' instead of the HIPAA-defined terms ``individual,'' 
``protected health information,'' and ``designated record set'' is not 
intended to suggest a different standard for covered entities subject 
to the HIPAA Privacy Rule. (See 45 CFR 164.524). We simply are using 
well-understood terms that are consistent across all of our 
regulations. The Office for Civil Rights recently issued Frequently 
asked Questions document about medical records access clarifying that 
the requirement to send medical records to the individual is within 30 
days (or 60 days if an extension is applicable) after receiving the 
request, ``however, in most cases, it is expected that the use of 
technology will enable the covered entity to fulfill the individual's 
request in far fewer than 30 days.'' (See http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/#newlyreleasedfaqs.) Individuals 
who have not been provided with their medical records within the 30-day 
timeframe required by HIPAA or who experience other difficulties 
accessing their medical records can file a complaint with Office for 
Civil Rights at: http://www.hhs.gov/hipaa/filing-a-complaint/index.html. We also refer the public to the following information 
pertaining to the Promoting Interoperability Program (formerly known as 
the EHR Incentive Program) and to an individual's rights under HIPAA to 
access their health information at the following websites: https://www.hhs.gov/hipaa/for-professionals/faq/2051/under-the-ehr-incentive-program-participating-providers/index.html and https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html.
    Comment: Commenters were generally supportive of this proposal.

[[Page 51848]]

Some commenters suggested allowing hospitals to provide to the patient 
copies of their medical record in the format that the facility deems 
appropriate at the time of the request if the patient has not specified 
a format for receiving the records. One commenter recommended that the 
regulation specify that discharge planning documents be immediately 
accessible to patients and their caregivers. The commenter notes that 
under the current medical record requirement (most likely the commenter 
is referring to Sec.  482.24), it is difficult for caregivers to obtain 
a medical record from a hospital until after discharge, even with the 
patient's signed consent.
    Response: This final rule states that the patient has the right to 
access their medical records in the form and format they request, if it 
is readily producible in such form and format. The medical record must 
include any discharge planning documents, so it is not necessary for 
this requirement to specify any specific part of the medical record as 
requested by the commenter. Patients are free to request their entire 
medical record or a specific portion of it if they choose, including 
any discharge planning documents, as noted by the commenter. However, 
these documents (and, by extension, the entire medical record) would 
obviously not be complete until after a patient is discharged. Further, 
the provision goes on to state that if the records are not readily 
producible in the form or format requested by the patient, the hospital 
must provide the records in a readable hard copy form or such other 
form and format as agreed to by the facility and the individual. We 
encourage hospitals to communicate with the patient to determine in 
which format they would prefer to receive the records; however, if no 
format is requested, the hospital has the flexibility to provide the 
records in a readable hard copy form.
    Final Decision: After consideration of the comments we received on 
this proposal for the Hospital Innovation proposed rule, we are 
finalizing Sec.  482.13(d)(2) with two minor editorial modifications.
    We are moving the phrase ``including current medical records'' to a 
more appropriate place in the text, that is, immediately following the 
opening language of the provision, ``The patient has the right to 
access their medical records,'' so that it now reads, ``The patient has 
the right to access their medical records, including current medical 
records . . .''
    In the proposed rule, we had awkwardly and inadvertently placed the 
phrase further along so it stated that the patient has the right to 
access their medical records, upon an oral or written request, in the 
form and format requested by the individual, if it is readily 
producible in such form and format (including in an electronic form or 
format when such medical records are maintained electronically); or, if 
not, in a readable hard copy form or such other form and format as 
agreed to by the facility and the individual, including current medical 
records, within a reasonable time frame.
    In removing the phrase from where it was proposed in the regulatory 
text, we have also added the word, ``and'' to precede the phrase, 
``within a reasonable time frame,'' so that it now more appropriately 
reads, ``. . . and within a reasonable time frame.''
2. Conditions of Participation (CoP)--Discharge Planning (Proposed 
Sec.  482.43)
    We proposed to revise the existing requirements in the form of 6 
standards at Sec.  482.43. The most notable proposed revision was to 
require that all inpatients and specific categories of outpatients be 
evaluated for their discharge needs and have a written discharge plan 
developed. We proposed to retain many of the current discharge planning 
concepts and requirements, but proposed to revise them to provide more 
clarity and to place emphasis on the development of each patient's 
individual discharge plan as opposed to the burdensome, current 
requirements that place more emphasis on the evaluations to determine 
which patients need discharge plans. We also proposed to require 
specific discharge instructions for all patients.
    We proposed to continue our efforts to reduce unnecessary and 
costly 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 persons (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 proposed at Sec.  482.43, Discharge planning introductory 
paragraph, to require that a hospital have an effective discharge 
planning process that focuses on the patients' 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.
    Our proposed hospital regulatory requirements were the basis for 
all other proposed discharge planning requirements as set out in the 
proposed rule. Since application of the proposed regulatory language 
for hospitals might be burdensome for CAHs and HHAs, we tailored 
specific proposed requirements to each providers' and suppliers' unique 
situation.
    Many commenters remarked on the proposed discharge planning 
regulations for hospitals, but indicated that their comments could also 
be applied to CAHs. Therefore, where appropriate, we included CAHs in 
this section of the final rule.
    Comment: Most commenters strongly supported a person-centered 
approach that places the patient at the center of the discharge 
planning process by requiring hospitals to develop and implement a 
discharge planning process that focuses on the patient's goals and 
preferences. Several of these commenters expressed concern that these 
proposed discharge planning requirements were unclear.
    Response: We thank the commenters for their feedback regarding a 
person-centered approach to discharge planning. We continue to believe 
that hospitals should take into consideration a patient's goals of care 
and treatment preferences and we note that person-centered care is 
particularly important when patients are discharged to home or to 
community-based services. In response to the public comments that we 
received that expressed concern about the clarity of the proposed 
discharge planning requirements, we have revised the wording of the 
requirements. Specifically, we are finalizing the discharge planning 
introductory paragraph with minor changes in Sec.  482.43, and we are 
continuing to emphasize the importance of the consideration of the 
patient's goals of care and treatment preferences during the discharge 
planning process and within the discharge plan. As we discuss in detail 
in the subsequent sections of this final rule, we also align, where 
appropriate, and as informed by the public comments, our final 
discharge planning requirements for hospitals (and CAHs) with the 
mandates in section 1861(ee)(1) of the Act.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing the first sentence in the 
introductory paragraph

[[Page 51849]]

of Sec.  482.43 with minor modifications, to state that the hospital 
must have an effective discharge planning process that focuses on the 
patient's goals and treatment preferences and includes the patient and 
his or her caregivers/support person(s) as active partners in the 
discharge planning for post-discharge care. The discharge planning 
process and the discharge plan must be consistent with the patient's 
goals for care and his or her treatment preferences, ensure an 
effective transition of the patient from hospital to post-discharge 
care, and reduce the factors leading to preventable hospital 
readmissions. The remaining language for the introductory paragraph 
remains the same.
3. Design (Proposed Sec.  482.43(a))
    We proposed to establish a new standard, at Sec.  482.43(a), 
``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 proposed 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.
    Comment: A number of commenters approved of the proposed new 
standard at Sec.  482.43(a), including one commenter that noted that 
physician involvement in the design of a hospital's discharge policies 
and procedures is essential to its success. Several commenters 
submitted comments questioning the proposed requirements regarding the 
role of the governing body, medical staff, and relevant departments in 
relationship to developing the discharge planning process, and 
suggested that the final regulations be much less prescriptive 
regarding these roles. One commenter questioned the practical 
enforceability of the requirement for a hospital to have its discharge 
planning process in writing and approved by the hospital's governing 
body. Many commenters made suggestions for additions of specific 
disciplines and entities to be consulted when developing the discharge 
planning process. One comment suggested that hospitals and CAHs should 
be required to use a risk-stratification approach (that is, an approach 
for identifying and predicting which patients are at high risk, or 
likely to be at high risk, and prioritizing the management of their 
care in order to prevent worse outcomes) among the elements of a 
hospital's discharge planning policies and procedures. Another 
commenter suggested that there should be a requirement for performance 
metrics as part of the design of a discharge process so as to inform 
formative assessment of policies, plans, and procedures, and their 
success or need for change. Still other commenters recommended that CMS 
not be overly prescriptive in the proposed design of the discharge 
planning process, and recommended that CMS put forward a design 
approach that would allow for customization based on patient needs. 
However, most commenters who made suggestions related to this section 
expressed concern about the burden of the proposed design requirement 
and whether those burdens outweighed any potential, though not proven, 
benefits of the requirements.
    Response: Based on the comments that we received, we agree with 
commenters who stated that this proposal was too process-oriented and 
too prescriptive. Further, we believe that any additional requirements 
added to this section would make the discharge planning requirements 
even more prescriptive and burdensome, which would not reflect the 
concerns expressed by the majority of commenters. We therefore are not 
finalizing the requirements in Sec.  482.43(a). Hospitals and CAHs may 
choose to include any of the factors that we originally proposed, as 
well as those described by commenters, in designing their discharge 
planning process. We encourage hospitals and CAHs to consider 
performance metrics when designing their discharge processes. We also 
encourage the use of performance metrics for hospitals when they 
reassess their discharge planning processes on a regular basis and urge 
hospitals to consider including these reassessments as projects within 
their Quality Assessment and Performance Improvement (QAPI) programs.
    Comment: Several commenters recommended that CMS require hospitals 
to review their discharge planning processes every 2 years.
    Response: We continue to believe that hospitals and CAHs should 
assess their discharge planning processes on a regular basis. However, 
we believe that it is not appropriate, and is in fact unduly 
burdensome, to establish a specific timeframe for this review. We 
believe that each hospital and CAH should have the flexibility to 
establish its own timeframe for periodic review. While we are not 
establishing a specific timeframe requirement in order to preserve 
flexibility for hospitals and CAHs, we would recommend that a hospital 
or CAH to do its periodic review every 2 years at a minimum. In 
addition, hospitals and CAHs would still have the flexibility to 
perform this review more frequently than every 2 years if they wish to 
do so.
    We therefore are finalizing a provision at Sec.  482.43(a)(7) (as 
originally proposed at Sec.  482.43(c)(10)) that would require a 
hospital (or a CAH) to assess its discharge planning process on a 
regular basis, which would 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.
    Comment: One commenter recommended that the final rule include an 
explicit requirement that a hospital's discharge policies and 
procedures accommodate the needs of patients whose primary language is 
not English.
    Response: As we noted previously, and in order to encourage patient 
engagement and understanding of their discharge plan or instructions, 
we recommend providers follow the National Standards for Culturally and 
Linguistically Appropriate Services (CLAS) in Health and Health Care 
(https://www.thinkculturalhealth.hhs.gov/clas/standards), which provide 
guidance on providing instructions in a culturally and linguistically 
appropriate manner.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are not finalizing the proposed design 
requirements at Sec.  482.43(a).
4. Applicability (Proposed Sec.  482.43(b))
    We proposed to revise the current requirement (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 proposed to 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 (since these patients are often kept in the 
hospital overnight), 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 thought at the time that the aforementioned categories of patients 
would benefit from an evaluation of

[[Page 51850]]

their discharge needs and the development of a written discharge plan.
    Comment: While a number of commenters agreed with the proposal to 
broaden the categories of patients who would be evaluated for post-
discharge need, stating that they believed the inclusion of these 
categories of patients was necessary for effective transition from 
acute settings to post-acute settings, the majority of commenters 
expressed concern over the undue burden that they believe would result 
from this proposed change, particularly for small and rural hospitals. 
Many stated that they believe that the current evaluation requirement 
is effective for screening and targeting high-risk patients who have 
true discharge needs. A number of commenters stated that they already 
routinely screen certain categories of outpatients, such as observation 
patients, and that automatically requiring discharge plans for patients 
in these categories would shift resources away from those patients most 
in need of discharge plan.
    Response: We agree with commenters that the requirement needs to be 
scaled back in its scope and applicability to a more flexible 
requirement. We also agree that the proposed requirement could 
potentially have the unintended consequence of shifting hospital 
resources away from those patients most in need of a discharge plan. 
Finally, we agree with commenters that a discharge planning evaluation 
and screening of patients who have discharge needs is a more 
appropriate approach to selecting patients for establishing a discharge 
evaluation. We therefore are not finalizing the requirements at 
proposed Sec.  482.43(b). Instead, we are finalizing requirements at 
Sec.  482.43(a) introductory text and (a)(2), respectively, that would 
require that a hospital's discharge planning process must identify, at 
an early stage of hospitalization (ideally when the patient is admitted 
as an inpatient, or shortly thereafter), those patients who are likely 
to suffer adverse health consequences upon discharge in the absence of 
adequate discharge planning and must provide a discharge planning 
evaluation for those patients so identified, as well as for other 
patients upon the request of the patient, patient's representative, or 
patient's physician. In addition, at Sec.  482.43(a)(2), a discharge 
planning evaluation must include an evaluation of a patient's likely 
need for appropriate post-hospital services, including, but not limited 
to, hospice care services, post-hospital extended care services, and 
home health services, and must also determine the availability of those 
services.
    The regulatory flexibility and framework of these final 
requirements will allow each hospital to establish and tailor its own 
policy parameters for discharge planning evaluations according to its 
specific patient populations, individual institutional needs and 
resources, and own medical staff recommendations as long as the 
policies and procedures established and implemented meet or exceed the 
requirements finalized in this rule.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are revising proposed Sec.  482.43(b), to be 
finalized as Sec.  482.43(a) introductory text and (a)(2), to require 
that the hospital's discharge planning process identify, at an early 
stage of hospitalization, those patients who are likely to suffer 
adverse health consequences upon discharge in the absence of adequate 
discharge planning, and must provide a discharge planning evaluation 
for those patients so identified, as well as for other patients upon 
the request of the patient, patient's representative, or patient's 
physician. A discharge planning evaluation must include an evaluation 
of a patient's likely need for appropriate post-hospital services, 
including, but not limited to, hospice care services, post-hospital 
extended care services, and home health services; such evaluation must 
also determine the availability of those services.
5. Discharge Planning Process (Proposed Sec.  482.43(c))
    We proposed 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). We proposed to require that the discharge plan be 
tailored to the unique goals, preferences, and needs of the patient. We 
proposed 10 specific elements to be addressed in the discharge planning 
process as follows:
     Proposed Sec.  482.43(c)(1): We proposed that an RN, 
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.
     Proposed Sec.  482.43(c)(2): We proposed to require that a 
hospital must 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.
     Proposed Sec.  482.43(c)(3): We proposed to retain and 
clarify the current requirement at Sec.  482.43(c)(4), regarding 
reassessment of the plan as necessary. We also proposed to require that 
the hospital's discharge planning process ensure an ongoing patient 
evaluation throughout the patient's hospital stay or visit in order to 
identify any changes in the patient's condition that would require 
modifications to the discharge plan.
     Proposed Sec.  482.43(c)(4): We proposed 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.
     Proposed Sec.  482.43(c)(5): We proposed 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. We proposed that hospitals consider the patient's or 
caregiver's capability and availability to provide the necessary post 
hospital care. We proposed that hospitals consider the availability of, 
and access to, non-health care services for patients. We proposed that 
hospitals 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.
     Proposed Sec.  482.43(c)(6): We proposed a new requirement 
that the patient and the caregiver/support person(s), be involved in 
the development of the discharge plan and

[[Page 51851]]

informed of the final plan to prepare them for post-hospital care.
     Proposed Sec.  482.43(c)(7): We proposed a new requirement 
that the patient's discharge plan address the patient's goals of care 
and treatment preferences.
     Proposed Sec.  482.43(c)(8): We proposed that the hospital 
assist patients and their families in selecting a post-acute care 
provider by using and sharing data on quality measures and data on 
resource use measures as is relevant and applicable to the patient's 
goals of care and treatment preferences.
     Proposed Sec.  482.43(c)(9): We proposed to 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 could be made before discharge.
     Proposed Sec.  482.43(c)(10): We proposed to require 
hospitals to assess their discharge planning processes on a regular 
basis, including 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.
    Comment: Numerous commenters expressed overall disagreement with 
the overly detailed, prescriptive nature of the proposed requirements. 
While they supported the overall goal of improving discharge planning, 
commenters expressed concern about stifling innovation, interfering 
with patient-provider relationships, overburdening discharge planning 
staff, and diverting patient care resources to regulatory process 
requirements.
    Response: We are sensitive to the concerns expressed by commenters, 
as we share their goal of streamlining the regulations to balance the 
need for minimum health and safety requirements with the need for 
maximum hospital flexibility to achieve patient outcomes. In light of 
the concerns expressed by commenters, we have significantly revised the 
proposed requirements to focus less on specific processes and 
prescriptive elements, and more on overall outcomes and flexibilities. 
We have also reorganized and simplified the regulatory requirements 
(such as those originally proposed in Sec.  482.43(c)(9) and (10)), 
where appropriate, to improve their clarity and understandability.
    Comment: A small number of commenters recommended that we mandate 
that nurses with training and experience in rehabilitation, as well as 
respiratory therapists, be involved in the discharge needs evaluation 
and in the development of the discharge plan.
    Response: We do not believe that it is appropriate to require 
hospitals to use certain specialty practitioners in any particular step 
of the discharge planning process. However, hospitals are not precluded 
from doing so. We believe that the requirements should allow hospitals 
to determine what is appropriate for its patient population and its 
facility in such circumstances.
    Comment: The majority of commenters opposed the establishment of a 
specific timeframe of 24 hours after admission or registration for 
beginning to identify anticipated discharge needs for each applicable 
patient (proposed Sec.  482.43(c)(2)). Some commenters noted that 
applying a 24-hour requirement, without consideration of patient need, 
could result in a waste of valuable hospital resources or inaccurate 
conclusions.
    Response: We agree with commenters that setting rigid time frames 
may not take into account the facts and circumstances of a particular 
patient's care; therefore, we are removing this proposed requirement 
from this final rule.
    Comment: Several commenters supported our proposal to require that 
the hospital's discharge planning process require a regular re-
evaluation of the patient's condition to identify changes that require 
modification of the discharge plan and that the discharge plan be 
updated, as needed, to reflect these changes. However, one commenter 
asserted that this requirement is redundant, as it is already included 
in the regular course of care for patients. Another commenter supported 
the proposed requirement and noted that the needs of patients with 
dementia and their caregivers evolve frequently.
    Response: We continue to believe in the importance of requiring 
that hospital's discharge planning process require a regular re-
evaluation of the patient's condition to identify changes that require 
modification of the discharge plan and that the discharge plan be 
updated, as needed, to reflect these changes. 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). We are finalizing the requirement from 
proposed Sec.  482.43(c)(3) with modifications at Sec.  482.43(a)(6) in 
this final rule to 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. We note that these requirements would allow for 
hospitals to consider the specific needs of patients with dementia.
    Comment: One commenter requested that the interpretive guidance not 
impose a burdensome documentation requirement for hospitals when 
conducting the re-evaluation of a patient's discharge needs.
    Response: The interpretive guidance is developed in accordance with 
the CoP regulations. Therefore, while the interpretive guidance will 
further clarify the CoPs, they will not impose additional requirements 
beyond those in the CoPs.
    Comment: A few commenters requested clarification on the definition 
of ``the practitioner responsible for the care of the patient'' in the 
proposed requirement 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. The commenter asked 
whether the practitioner will always be a hospital-based provider or 
the patient's personal physician. One commenter noted that this 
requirement would be difficult to complete for a medically complex 
patient with multisystem involvement. One commenter opposed the 
inclusion of this requirement in the CoPs for hospitals on the basis 
that hospitals do not control practitioner-patient interaction. The 
commenter also noted the absence of an explanation regarding the 
language stating that a practitioner should be ``involved in'' the 
process.
    Response: We agree that the proposed requirement does not allow for 
flexibility for hospitals, CAHs, and practitioners, especially for 
multi-facility providers that treat medically complex patients. Taking 
into account the concerns that we have received on this proposal, we 
are not finalizing the proposed requirements in Sec.  482.43(c)(4).
    Comment: Many commenters supported the proposed requirement for 
hospitals to consider certain criteria while evaluating a patient's 
discharge needs, specifically highlighting proposals related to 
psychiatric and behavioral health needs, and non-medical needs and 
support services. Some commenters suggested that hospitals should be 
required to inform patients and their caregivers of their right to 
receive post-acute care in their home or a community setting, as is 
appropriate for the patient's care and

[[Page 51852]]

needs, so long as the placement can be reasonably accommodated. One 
commenter recommended that hospitals review a patient's need for the 
use of technology and whether or not technology is necessary to 
maintain a patient's health and safety or individual goals. A few 
commenters recommended specific revisions to the proposed requirement 
that the hospital consider the availability of caregivers and 
community-based care for each patient, including recommendations such 
as requiring hospitals to consider a patient's socioeconomic condition 
when identifying and evaluating a patient's anticipated post-discharge 
needs, and consider patient eligibility for Program of All-Inclusive 
Care for the Elderly (PACE) and services through the Veterans 
Administration.
    However, other commenters stated that the proposed requirements 
that a hospital must consider in evaluating a patient's discharge needs 
are overly prescriptive and overly detailed. A few commenters stated 
that a requirement to consider a patient's access to non-health care 
services and community-based care providers would be burdensome for 
hospitals. One commenter stated that while these services may benefit 
the patient, hospitals cannot be expected to provide an exhaustive list 
of services and that the hospital has limited reliable methods to 
identify non-health care resources in the community.
    One commenter disagreed with the use of the term ``consider'' in 
the proposed requirement, stating that using the term ``consider'' may 
cause interpretation differences when surveying for compliance. The 
commenter recommended that CMS clarify that discharge plans can vary, 
depending on the patient, and that in many cases a patient's discharge 
instructions could constitute a ``discharge plan.'' The commenter also 
recommended that CMS coordinate with AOs to develop mutually agreed 
upon interpretive guidelines, which all surveyors would use when 
assessing compliance with this provision.
    Response: We agree that the proposed list could be burdensome, and, 
therefore, we are not finalizing it in this final rule. We are instead 
finalizing a requirement at Sec.  482.43(a)(2) that a discharge 
planning evaluation include an evaluation of a patient's likely need 
for appropriate post-hospital services, including, but not limited to, 
hospice care services, post-hospital extended care services, home 
health services, and non-health care services and community based care 
providers, and that the evaluation must also include a determination of 
the availability of the appropriate services as well as of the 
patient's access to those services.
    We acknowledge that patients and families seeking post-hospital 
non-health care services, as well as the discharge planning staff of 
hospitals assisting them with this process, frequently find themselves 
confronted with what can be an overwhelming number of organizations and 
requirements. This search occurs at a time of vulnerability or crisis, 
and can result in patients, families, and caregivers making decisions 
based on incomplete, and sometimes inaccurate, information about their 
options. In partnership with the Veterans Health Administration and the 
Administration for Community Living (ACL) within HHS, CMS is working 
collaboratively with states to streamline access to long-term services 
and supports (LTSS) through a network of organizations, including Aging 
& Disability Resource Centers (ADRCs), Area Agencies on Aging (AAAs), 
and Centers for Independent Living (CILs)) that make up a statewide No 
Wrong Door (NWD) system. We expect that CILs, AAAs, and ADRCs would 
assist patients in accessing LTSS, and would have staff trained to help 
patients and their families exercise their choice and control over the 
types of LTSS that work best for them in their lives. Along with the 
U.S. Department of Veterans Affairs, CMS formally recognized the 
importance of state ADRC/NWD systems by publishing the NWD System 
Medicaid Administrative Guidance (https://www.medicaid.gov/medicaid/financing-and-reimbursement/downloads/no-wrong-door-guidance.pdf) and 
the ``Expanded Access to Non-VA Care Through the Veterans Choice 
Program Rule'' interim final rule (80 FR 674991, December 1, 2015.)
    We therefore urge hospitals to develop collaborative partnerships 
with these community based care organizations in their respective areas 
to improve transitions of care that might support better patient 
outcomes. Regarding hospital expectations, hospitals are required to 
comply with all applicable Federal laws, including the Americans with 
Disabilities Act (ADA). It is our expectation that hospitals would 
administer their services, programs, and activities in the most 
integrated setting appropriate to individuals with disabilities, in 
compliance with the ADA. For further information on ADA compliance, we 
recommend that readers visit https://www.ada.gov/. For further 
information about other nondiscrimination laws see http://www.hhs.gov/civil-rights. We expect hospitals to develop collaborative 
relationships with their area and state ADRCs, AAAs, and CILs that are 
knowledgeable of the availability of these services in the community 
and would be able to help connect patients as well as their families, 
friends, and caregivers to these resources. We would also expect that 
these hospital efforts to collaborate and to connect patients with 
these types of community-based care organizations will be documented in 
the medical record. It is for this reason that we urge hospitals to 
develop ongoing and collaborative partnerships with ADRCs, AAAs, and 
CILs. We remind hospitals that they can find more information on 
community-based services and community-based organizations at http://www.acl.gov/.
    Considerations must also be made for those patients whose personal 
homes have been adversely impacted due to an emergency or disaster. We 
note that the Emergency Preparedness final rule requires health care 
facilities to communicate with state and local officials during a 
disaster (81 FR 63860, September 16, 2016). Therefore, in the event of 
such an emergency, we would expect that patients that are determined 
for safe discharge to a personal home that may have been adversely 
impacted should not be directed to shelters without prior consultation 
with public health and emergency management officials overseeing those 
shelters. Additionally, we would expect that patients that are 
anticipated to be discharged to another inpatient facility that may be 
adversely impacted should not be sent to a shelter without prior 
consultation with public health and emergency management officials 
overseeing those shelters and with health care coalitions, where 
available, that may know of other inpatient facility options. In 
addition, we refer readers to guidance from Office for Civil Rights on 
emergency preparedness and ensuring at risk individuals have access to 
emergency services at the following link: https://www.hhs.gov/civil-rights/for-individuals/special-topics/emergency-preparedness/index.html.
    Comment: We received several comments regarding community based 
care organizations. Comments included the following recommendations:
     Mandate that providers collaborate and coordinate with 
community based organizations on the availability of community supports 
at discharge.
     Include specific references to CILs, ADRCs, and AAAs in 
the regulation and provide patient instructions on their use.

[[Page 51853]]

     Clarify how collaboration between hospitals and community 
based organizations would be encouraged and funded, including requiring 
Medicare and Medicaid reimbursement of AAAs and community-based 
organizations.
     Require that community based providers be included in the 
early stages of planning for a patient's discharge.
     Clarify how a hospital would know what facility or agency 
a patient would use before discharge.
     Clarify timelines for considering the availability of, and 
access to, non-health care services for patients, specifically in 
instances where the post-acute care provider had a physical 
accessibility issue.
    Response: As we have already stated in this final rule, we believe 
that community based care organizations, including CILs, ADRCs, and 
AAAs, play an important part in helping individuals, who are returning 
home or who want to avoid institutionalization, by connecting them to 
community services and supports. Currently, many of these organizations 
already help older adults and people with disabilities with transitions 
across settings, from hospitals and PAC settings back to home. Because 
of the important role that community based organizations play, we 
strongly encourage hospitals to develop collaborative partnerships with 
providers of community-based services. We believe that such 
collaboration will help with successful patient transitions.
    While we encourage, and even urge, collaboration with organizations 
such as CILs, AAAs, and ADRCs to assist patients with access to LTSS, 
we believe that mandating a collaborative relationship could be overly 
burdensome for hospitals. In order to demonstrate compliance with a 
proof of collaboration requirement like the one recommended here by 
some commenters, hospitals would need to provide extensive 
documentation solely for Medicare certification and participation 
purposes. Such an approach runs counter to current CMS initiatives to 
place patients over paperwork. Hospitals should be afforded the 
flexibility to provide information about these organizations and 
collaborate with these entities as is appropriate for the patient and 
based on the patient's goals of care and treatment preferences. We 
expect that hospitals would be responsive to the patient regarding his 
or her needs and provide information to the patient about these 
organizations as well as form collaborative relationships with these 
entities as appropriate.
    This final rule does not mandate a specific methodology for how 
collaboration between hospitals and community based providers should be 
conducted nor does it mandate that hospitals (when developing a patient 
discharge plan) must consider a patient's eligibility for community 
based services, any patient wait lists for services, or any time frames 
established by community based providers for the initiation of 
services. We believe that such detailed mandates would be overly 
burdensome for hospitals and inappropriate for these regulations. 
However, as we stated above, we are finalizing a requirement at Sec.  
482.43(a)(2) that a hospital include an evaluation of a patient's 
likely need for appropriate non-health care services and community 
based care providers, and must also include a determination of the 
availability of, and the patient's access to, those services as part of 
the patient's discharge planning evaluation. We encourage hospital 
personnel to be knowledgeable about the services that are provided by 
their local community based organizations and expect hospital personnel 
to be able to offer their patients guidance on how to connect with 
their local community based organizations. Once a patient is 
discharged, we would not expect hospitals and CAHs to be responsible 
for ensuring that a patient has received non-health care services 
(including home modifications), as this would be outside the scope of a 
hospital's or CAH's responsibility. Once a patient is connected with a 
community based organization, such as an ADRC, AAA, or CIL, the 
responsibility for ensuring that the patient is actually receiving non-
health care services, including home modifications, becomes that of the 
community based organization and the community provider of the services 
and supports. We also do not believe that hospitals and CAHs should 
hold patients until physical accessibility issues are resolved, 
although we understand that sometimes hospitals hold patients until a 
bed is available at a corresponding PAC facility. Hospitals and CAHs 
can provide patients with resources regarding supportive housing and 
home and physical environment modifications including assistive 
technologies and, where appropriate, medical equipment and supplies, 
including back-up batteries. We refer readers to further guidance that 
can be found in the previously provided web links in the discussion on 
the proposed requirements for Sec.  482.43(c)(5) and on the final 
requirements for Sec.  482.43(a)(2) of this final rule.
    Finally, comments regarding funding for community based 
organizations are outside the scope of this rule.
    Comment: Many commenters supported the proposal to require that the 
discharge plan address the patient's goals of care and treatment 
preferences. A few commenters asked for clarification on how hospitals 
will be expected to demonstrate the incorporation of the patient's 
goals and wishes into the plan. The commenters gave specific examples 
of instances where patients may leave against medical advice, may be 
undocumented and not as forthcoming about information, or patients who 
may be embarrassed about needing social services. The commenters noted 
that hospitals should try to work with the patients as much as possible 
and should not be penalized if patients decline medical or discharge 
planning assistance. One commenter stated that sometimes patient goals 
and preferences are not consistent with the clinical needs of the 
patient or the resources available to the patient post-discharge. 
Therefore, the commenter concluded that the patient's goals and 
preferences cannot be fully accommodated in the final discharge plan. 
The commenter recommended that CMS modify the language used in the rule 
and clarify that the patient's goals and preferences must be considered 
during the discharge planning process, but that it is ultimately the 
decision of the practitioner responsible for the care of the patient 
whether the goals and preferences can be incorporated into the 
discharge plan.
    Response: While we are modifying this proposal by finalizing it in 
the introductory paragraph at Sec.  482.43, we note that we still 
expect that the patient's goals of care and treatment preferences would 
be included in the patient's medical records. Similarly, we understand 
that situations may arise where patients may be uncooperative or may 
refuse to participate in the discharge planning process. We also expect 
hospitals and CAHs to document the patient's refusal to participate in 
the discharge planning process, and that such attempts to incorporate 
the patient and/or the patient's caregiver in the discharge planning 
process were made, in the medical record. While we understand the 
commenter's concerns that a patient's goals of care and treatment 
preferences might not always align with the practitioner's recommended 
medical care, we continue to believe that it is important for hospitals 
and CAHs to develop and implement an effective discharge planning 
process that focuses on and,

[[Page 51854]]

where appropriate, is consistent with the patient's goals and 
preferences. We expect that these goals and preferences will be 
included in the discharge plan and would reasonably relate to the 
patient's medical care or treatment preferences, preferred non-health 
care services, post-acute care, or community-based care post-
hospitalization. While we expect that practitioners will establish the 
most appropriate course of care for their patient and document this in 
the patient's discharge plan, we note that patients cannot be forced to 
follow their discharge plan and that patients have the right to refuse 
treatment or to leave the hospital or CAH against medical advice.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing the discharge planning 
requirements with the following modifications:
     Revising the language in the introductory paragraph of 
Sec.  482.43.
     Revising and redesignating proposed Sec.  482.43(a), (b), 
and (c) as Sec.  482.43(a) ``Discharge planning process.'' As revised, 
Sec.  482.43(a) will incorporate and combine provisions of the current 
hospital discharge planning requirements (some of which are statutorily 
required for hospitals) with revised elements contained within some 
provisions of the proposed requirements at Sec.  482.43(c).
     Redesignating the requirements in proposed Sec.  
482.43(c)(10) as Sec.  482.43(a)(7), which would still require 
hospitals to assess their discharge planning processes on a regular 
basis, which would 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.
     Withdrawing our proposal at Sec.  482.43(c) to require 
that 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.
     Revising and redesignating the requirements in proposed 
Sec.  482.43(c)(1) to state that any discharge planning evaluation or 
discharge plan required under this paragraph must be developed by, or 
under the supervision of, a registered nurse, social worker, or other 
appropriately qualified personnel. We are finalizing these requirements 
as Sec.  482.43(a)(5).
     Revising and redesignating Sec.  482.43(c)(2) to eliminate 
the 24-hour time frame requirements and retaining, with minor 
revisions, the current requirements at Sec.  482.43(a) to state that 
the hospital must identify at an early stage of hospitalization all 
patients who are likely to suffer adverse health consequences upon 
discharge if there is no adequate discharge planning. The hospital must 
provide a discharge planning evaluation for those patients so 
identified as well as for other patients upon the request of the 
patient, the patient's representative, or patient's physician. We are 
finalizing these requirements as Sec.  482.43(a).
     Finalizing proposed Sec.  482.43(c)(3) without 
modification and redesignating these requirements as Sec.  482.43(a)(6) 
to state that 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. Withdrawing 
proposed Sec.  482.43(c)(4). Revising Sec.  482.43(c)(5) to state that 
a discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-hospital services, 
including, but not limited to, hospice care services, post-hospital 
extended care services, and home health services, and non-health care 
services and community based care providers, and must also determine 
the availability of the appropriate services as well as of the 
patient's access to those services. We are including these requirements 
as Sec.  482.43(a)(2).
     Revising Sec.  482.43(c)(6) to state that the discharge 
planning evaluation must be included in the patient's medical record 
for use in establishing an appropriate discharge plan and the results 
of the evaluation must be discussed with the patient (or the patient's 
representative). This requirement will be included in Sec.  
482.43(a)(3).
     Modifying Sec.  482.43(c)(7) by requiring that hospitals 
have an effective discharge planning process that focuses on the 
patient's goals and preferences and includes the patient and his or her 
caregivers/support person(s) as active partners in the discharge 
planning for post-discharge care. The discharge planning process and 
the discharge plan must be consistent with the patient's goals for care 
and his or her treatment preferences, ensure an effective transition of 
the patient from hospital to post-discharge care, and reduce the 
factors leading to preventable hospital readmissions. These 
requirements are included in the introductory paragraph at Sec.  
482.43.
     Modifying the requirements at proposed Sec.  482.43(c)(9) 
to state that any discharge planning evaluation must be made on a 
timely basis to ensure that appropriate arrangements for post-hospital 
care will be made before discharge and to avoid unnecessary delays in 
discharge. We are finalizing these requirements in Sec.  482.43(a)(1).
     We are making a technical revision to the proposal at 
Sec.  482.43(c) to clarify the intent of the requirements related to 
post-acute care services. This requirement applies to patients whose 
discharge plan includes a referral to HHA services or transfer to a 
SNF, IRF, or LTCH.
6. Discharge to Home (Proposed Sec.  482.43(d))
    We proposed 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, and who 
require: Follow-up with their PCP and/or a specialist and who might 
also be receiving post-acute care from HHAs, hospice services, and/or 
any other type of outpatient health care services. The phrase 
``patients discharged to home'' would not refer to patients who are 
transferred to another inpatient hospital or CAH, inpatient hospice 
facility, or a SNF.
    Proposed Sec.  482.43(d)(1): We proposed 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 and who also might be referred to PAC services. We also proposed 
that practitioners/facilities (such as an 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.
    Proposed Sec.  482.43(d)(2): We proposed to set forth the minimum 
requirements for discharge instructions as follows: Instructions to the 
patient and his or her caregivers about care duties that they would 
need to perform in the patient's home as determined in the patient's 
discharge plan; written information on the warning signs and symptoms 
that

[[Page 51855]]

patients and caregivers should be aware of with respect to the 
patient's condition; all medications prescribed and over-the-counter 
for use after the patient's discharge from the hospital (with 
reconciliation of all medications used by the patient prior to 
admission), including the name, indication, and dosage of each 
medication along with any significant risks and side effects of each 
drug as appropriate to the patient; written instructions, in paper or 
electronic format (or both), provided to the patient; and documenting 
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.
    Proposed Sec.  482.43(d)(3): We proposed to require hospitals 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; and all other necessary information, as specified 
in proposed Sec.  482.43(e)(2).
    Proposed Sec.  482.43(d)(4): We proposed to require, for patients 
discharged to home, that the hospital establish a post-discharge 
follow-up process.
    Comment: Numerous commenters expressed overall disagreement with 
the overly detailed, prescriptive nature of the proposed requirements. 
While they supported the overall goal of improving discharge planning, 
commenters expressed concern about overburdening discharge planning 
staff, duplicating existing hospital discharge planning practices, and 
diverting patient care resources to regulatory process requirements.
    Response: We are sensitive to the concerns expressed by commenters, 
as we share their goal of streamlining the regulations to balance the 
need for minimum health and safety requirements with the need for 
maximum hospital flexibility to achieve patient outcomes. In light of 
the concerns expressed by commenters, we have removed the majority of 
the proposed requirements, specifically those at Sec.  482.43(d)(1), 
(2), and (4), and have significantly revised the requirements of 
proposed Sec.  482.43(d)(3) to reduce regulatory burden.
    Comment: Several commenters supported the proposal to provide 
discharge instructions to the patient and/or the patient's caregiver/
support person(s), and the PAC provider or supplier, if the patient is 
referred to PAC services. Additionally, some commenters sought 
clarification regarding specific issues, such as whether hospitals 
could share post-hospital care instructions with the patient and/or the 
patient's caregiver prior to actual discharge and whether there would 
be HIPAA violations when a hospital sent discharge instructions to the 
PAC provider or supplier.
    Response: Although we are not finalizing this requirement as 
proposed, hospitals or CAHs are not prevented from developing discharge 
instructions or sharing discharge information in accordance with 
applicable law earlier than the time of discharge. Additionally, we 
note that providing a patient with his or her discharge instructions is 
a long-standing standard of practice for hospitals when discharging 
inpatients as well as when releasing patients from care in other areas 
of the hospital (for example, the emergency and ambulatory surgery 
departments). Because of this, we believe that it is unnecessary to 
specifically require it here, but we encourage hospitals and CAHs to 
continue this long-standing standard of practice that serves as a 
simple way of not only informing, but also engaging, the patient (and/
or the patient's caregiver/support person(s)) regarding his or her 
continued care upon discharge from the hospital or CAH. We note 
hospitals, HHAs, and CAHs are required to send certain discharge 
information to the PAC provider or practitioner(s) responsible for 
follow-up care, if the practitioner is known and has been clearly 
identified. We have no reason to believe that sending discharge 
information to such PAC providers or suppliers would be considered a 
HIPAA violation, since disclosures for treatment, care coordination, 
and quality improvement purposes are generally permitted under 45 CFR 
part 164.
    Comment: Several commenters recommended that hospitals use the 
National CLAS Standards for guidance on providing instructions in a 
culturally and linguistically appropriate manner and also recommended 
the use of the ``teach-back'' method to confirm the patient's or the 
patient's caregiver/support person's (or both) understanding of the 
discharge instructions.
    Response: While we are not finalizing the proposed discharge 
instruction requirements discussed here (in response to public comments 
that noted the overly detailed, prescriptive nature of these proposed 
requirements) and although we also did not propose requirements that 
included the commenters' recommendations, we would still like to 
encourage hospitals to consider these recommendations for their 
discharge planning processes. Therefore, we refer readers to the 
following links for more information regarding the use of the ``teach-
back'' method during the discharge planning process as well as for 
additional information on the National CLAS standards:
     https://www.thinkculturalhealth.hhs.gov/clas/standards.
     http://www.teachbacktraining.org.
    Comment: A few commenters submitted comments regarding 
documentation. One commenter stated that hospitals should be required 
to include the patient's discharge instructions in the medical record, 
and that the medical record should also include documentation that the 
patient and caregiver were offered a demonstration of post-discharge 
care tasks and an opportunity to ask questions and receive answers on 
post-discharge care. A few commenters asked for clarification on the 
documentation requirements for patients that leave against medical 
advice.
    Response: We encourage hospitals and CAHs to document interactions 
with patients and/or their caregivers in the medical record as a best 
practice. Patient discharge instructions, as part of the record of 
patient care in the hospital, are already required to be included in 
the medical record under the Medical Record Services requirements in 
Sec.  482.24, so no new requirement is needed here. We understand that 
situations may arise where patients may prefer not to participate in 
the discharge planning process. For patients that decline to 
participate in the discharge planning process or leave the hospital or 
CAH against medical advice, we expect hospitals to document in the 
medical record the patient's refusal to participate in the discharge 
planning process, and that such attempts to include the patient and/or 
the patient's caregiver in the discharge planning process were made by 
hospital staff.
    Comment: We received several comments related to the content and 
implementation of the proposed discharge instructions requirement. 
While some commenters suggested that CMS include even more specificity 
in the requirements, most expressed concern that CMS was requiring too 
much information be provided to the patient upon discharge, and that 
CMS should not mandate what should be included in the discharge 
instructions. One commenter also disagreed with the requirement that 
discharge instructions

[[Page 51856]]

be written, and requested that CMS allow for other communication 
methods to share this information with patients.
    Response: We believe that the requirements of this section, as 
proposed, are overly prescriptive and we do not believe that it is 
appropriate to finalize a requirement that hospitals must provide 
specific written discharge instructions to patients. We believe that 
the overall involvement of the patient and caregivers, as set forth in 
Sec. Sec.  482.43 and 485.642, in addition to the already established 
practice of providing discharge instructions appropriate to each 
patient as is the current standard of care, will ensure appropriate 
communication between providers, patients, and caregivers throughout 
the discharge planning process.
    Comment: A few commenters asked about the role that Prescription 
Drug Monitoring Programs (PDMPs) should play in the discharge planning 
process.
    Response: As part of the medication reconciliation process, in the 
proposed rule we encouraged practitioners to consult with their state's 
PDMPs. We also solicited 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 as indicated by the PDMP 
report. While we continue to believe that practitioners should consult 
with their state's PDMP if they believe it appropriate to do so, we are 
not mandating the use of PDMPs at this time. We further note that our 
rule does not preempt or conflict with state laws that may require 
hospital consultation with PDMPs or other PDMP-related actions. We also 
refer readers to the discussion on PDMPs in section II.C of this final 
rule.
    Comment: Most commenters supported the proposed requirement that 
hospitals send a copy of the discharge instructions and the discharge 
summary, pending test results, and other necessary information to the 
practitioner(s) responsible for follow-up care, if the practitioner is 
known and has been clearly identified, and cited the importance of this 
information for these practitioners. However, most commenters stated 
that the required timeframes were overly prescriptive and requested 
more flexibility pertaining to these timeframes. Several commenters 
noted the challenges that the lack of adoption of interoperable health 
IT among follow-up practitioners poses for hospitals. Two commenters 
requested that, instead of sending test results, hospitals instead be 
required to make such test results available or accessible to the 
follow-up practitioner(s). Two commenters felt that the timeframes 
included in the proposed rule were too flexible and that the required 
information should be sent to the practitioner(s) responsible for the 
follow-up care of the patient at the time of discharge to prevent any 
unnecessary delays in the patient's follow-up treatment.
    Response: We agree with the commenters that specific timeframe 
requirements may not be reasonable or appropriate in all situations. In 
this final rule, we are eliminating the specific timeframe requirements 
proposed in this section and revising the requirements for hospitals 
and CAHs to send information to the practitioner(s) responsible for 
follow-up care prior to the patient's first follow-up visit with the 
practitioner(s). We further note that we are finalizing a requirement 
that hospitals and CAHs must discharge the patient, and transfer or 
refer the patient where applicable, along with all necessary medical 
information pertaining to the patient's current course of illness and 
treatment, post-discharge goals of care, and treatment preferences, at 
the time of discharge, to the practitioners responsible for the 
patient's follow-up or ancillary care at Sec.  482.43(b). We refer 
readers to section II.E.7 of this final rule for a more detailed 
discussion of this requirement.
    We are not proposing a specific form, format, or methodology for 
the communication of this information; however, 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 note that HHS has a number of initiatives designed to encourage and 
support the adoption of health IT and to promote nationwide health 
information exchange to improve the quality of health care. While 
pending test results clearly would be included as part of a patient's 
necessary medical information that we are requiring be sent upon 
discharge to facilities and practitioners providing PAC and follow-up 
services to the patient, we also recognize that the very nature of 
these test results being ``pending'' precludes them from being sent at 
that time and hospitals would not be held accountable for sending 
information that they simply do not have at the time of discharge. We 
encourage hospitals and CAHs to find their own innovative and unique 
solutions to solve this issue, including any means that would ensure 
that these pending results are available and accessible to the 
appropriate facilities and practitioners at the appropriate time.
    Comment: Many comments were submitted regarding the requirement to 
provide discharge information to the practitioner(s) responsible for 
follow up care. One commenter stated that the list of information may 
be duplicative and, in some cases, excessive. The commenters added that 
for patients following up with their primary care provider, many of the 
preventive and baseline medical history items, as well as a 
psychosocial assessment, would already be known to the provider. Two 
commenters recommended that CMS require hospitals to provide the 
required necessary medical information, to dialysis facilities, 
dialysis units, or nephrologists within 48 hours of discharge. A few 
commenters questioned how the hospital would monitor the information 
sent by the hospital to the practitioner(s) responsible for follow-up 
care of the patient who is being discharged to their home.
    Response: We have revised this requirement to remove a number of 
items that were proposed to be included as part of what many commenters 
described as an overly and unnecessarily prescriptive list of patient 
medical information that was to be sent. In this final rule, the 
hospital is now only required to provide certain necessary medical 
information that we believe allows a hospital the flexibility to 
effectively determine and align the pertinent patient information with 
a specific patient based on the clinical judgment of the practitioners 
responsible for the care of the patient since they are the 
practitioners who know the patient best while he or she is receiving 
care in the hospital. As many commenters noted, and with which we 
agree, a more flexible regulatory approach, such as we are finalizing 
here, allowing for the determination and transfer of a particular 
patient's necessary medical information will provide a more thoughtful 
and effective means to ensure better continuity of care for a patient 
being discharged. However this requirement as finalized in this rule 
will not limit the types and amount of patient information that can be 
shared with practitioners responsible for the patient's follow-up or 
ancillary care, but will also allow the inclusion of any additional 
clinically relevant information that the hospital's or CAH's 
practitioners believe would be beneficial for the patient's transition 
from one care setting to another.
    Similarly, this requirement that a patient's necessary medical 
information must be transferred at the time of discharge (and transfer 
or referral as

[[Page 51857]]

applicable) to the appropriate post-acute care service providers and 
suppliers, facilities, agencies, and other outpatient service providers 
and practitioners responsible for the patient's follow-up or ancillary 
care would also include dialysis facilities, dialysis units, and 
nephrologists for those patients where this is relevant and 
appropriate. Therefore, we respectfully disagree that mandating 
specific provider and supplier types as well as specific categories of 
practitioners in these requirements is necessary or appropriate. We 
note that we encourage providers to include any additional necessary 
medical information as part of the discharge summary as appropriate and 
also encourage them to ensure that any specific providers or suppliers 
or specialty practitioners that are clinically relevant to a particular 
patient be included in the conveyance of the necessary medical 
information upon discharge; for instance, when the hospital's health IT 
system is used to populate a discharge summary with relevant 
information from the patient's record. The hospital will not be 
responsible for monitoring information if it has been provided to the 
practitioner.
    Further, we understand that there are special care needs for 
patients that are diagnosed with chronic illnesses such as kidney 
disease, diabetes, etc., and our requirements allow facilities to 
address and acknowledge these needs by sending a patient's necessary 
medical information to a special needs facility/provider such as a 
dialysis facility or nephrologist, if this information is known. 
However, we believe it would be burdensome to specifically mandate that 
facilities send this information to these providers and practitioners, 
or to prescribe a specific timeframe for sending the information. 
Instead, we are allowing facilities to have the flexibility to 
determine when and if this information should be sent. However, we must 
note here again that a patient's dialysis care plan information is part 
of his or her necessary medical information. We believe that this 
information should be conveyed upon discharge or transfer since such 
information is clearly necessary medical information and should be 
transferred with the patient. As for all requirements in this 
regulation, further implementation guidance will be provided. 
Furthermore, we believe that providing pertinent information such as 
specialized assessments and information regarding DME needs is a 
valuable piece of necessary medical information. We also expect that 
hospitals are providing any necessary requested information to follow 
up providers.
    Comment: One commenter stated that the discharge instructions 
should be provided to HHAs prior to or at the time of discharge when 
the patient is referred to home health services following discharge to 
home from the hospital. The commenter also suggested that in cases in 
which the patient was receiving home health services prior to the 
current hospitalization, hospitals should be required to maintain 
ongoing communications with the HHA. The commenter believes that the 
HHA that was providing services to the patient prior to the current 
hospital admission should continue to be the patient's PAC provider 
should the patient be referred for home health services following the 
current inpatient admission if the patient chooses.
    Response: While we have revised and relocated some of the proposed 
requirements in this final rule, we have essentially retained (with 
some clarifying modifications as well as the addition of some important 
elements of the proposed requirements for this section) the current 
requirement that the hospital must transfer or refer the patient, along 
with his or her necessary medical information, to appropriate 
facilities, agencies, or outpatient services, as needed, for follow-up 
or ancillary care upon discharge. We are finalizing the requirement as 
standard (b) ``Discharge of the patient and provision and transmission 
of the patient's necessary medical information,'' will require the 
hospital (or the CAH) to discharge the patient, and also transfer or 
refer the patient where applicable, along with all necessary medical 
information pertaining to the patient's current course of illness and 
treatment, post-discharge goals of care, and treatment preferences, at 
the time of discharge, to the appropriate post-acute care service 
providers and suppliers, facilities, agencies, and other outpatient 
service providers and practitioners responsible for the patient's 
follow-up or ancillary care.
    In this final rule, the patient must be referred to a Medicare-
participating HHA that serves the geographic area (as defined by the 
HHA) in which the patient resides. It is expected that the patient be 
referred to an HHA that can meet the clinical needs of the patient as 
indicated in the patient's discharge plan. If the patient was receiving 
home health services prior to the current hospital admission and the 
patient is referred for home health services following their discharge 
from the current admission, we expect that the patient be given the 
option to continue to receive services from the same HHA if they so 
choose so long as the HHA is still appropriate to meet the needs of the 
patient and the HHA still meets the requirements under proposed Sec.  
482.43(f)(1) (finalized here as Sec.  482.43(c)(1)). We do not believe 
that we should require a patient to maintain a relationship with a 
provider if the patient wishes otherwise.
    Comment: One commenter suggested that we develop a policy that 
would facilitate improved payer-provider collaboration and coordination 
with the discharge planning process so that managed care companies are 
also held to these same requirements.
    Response: This comment pertains to the oversight of managed care 
organizations rather than to any specific proposed changes to the 
discharge planning policy proposals set forth in the Discharge Planning 
proposed rule. The comment is therefore outside the scope of this final 
rule.
    Comment: One commenter questioned if there should be a requirement 
for the hospital to use reasonable efforts to determine the identity of 
the practitioner(s) responsible for the follow-up care of the patient 
being discharged to home, and to communicate with that practitioner.
    Response: We expect that hospitals are already using reasonable 
efforts to determine who the practitioner(s) responsible for the 
follow-up care of the patient is and, in many cases, hospitals are 
scheduling the follow-up appointments for those patients who are being 
discharged to home. Most hospitals have discharge policies in place 
that include assigning patients to one of their physicians who see 
outpatients--either on staff or who have privileges at that hospital, 
if the patient does not have a primary care physician or an appropriate 
practitioner who is responsible for the follow-up care of the patient. 
Thus, we expect hospitals will have processes in place to routinely and 
consistently identify a follow up practitioner for every patient 
discharged.
    Comment: While commenters supported the goals of a post-discharge 
follow-up process, some commenters noted that the evidence is still 
being developed on how best to do this and disagreed that all patients 
would even require post-discharge follow-up.
    Response: While we continue to believe that a post-discharge 
follow-up process has value for certain patients, for the reasons we 
gave in the proposed rule (80 FR 68135), we have decided to remove this 
requirement from this final

[[Page 51858]]

rule since we believe that most hospitals are already doing this 
according to their specific situations and patient populations, and 
patient risk levels. We note the importance of ensuring that hospitals 
follow-up, post-discharge, with their most vulnerable patients, 
including those with behavioral health conditions. As a result, we 
encourage hospitals to research evidenced-based best practices and 
determine and implement a process that best meets the needs of their 
patient population. It should be noted that CMS continues to use other 
levers at its disposal, which are separate from the regulatory ones in 
the CoPs discussed here, to encourage reductions in the number of 
unnecessary readmissions and to improve post-discharge patient 
outcomes. This emphasis on reducing preventable readmissions, 
especially for the most vulnerable patient populations, remains a high 
priority for CMS.
    Comment: Several commenters requested that we investigate payment 
models that will support the hospital's establishment of a post-
discharge follow-up process for patients discharged to home. One 
commenter stated that health plans should be responsible for following 
up with their enrollees after a hospital discharge.
    Response: These comments do not pertain to any specific proposed 
changes to the discharge planning policy proposals, and therefore are 
outside the scope of this final rule.
    Final Decision: After consideration of the public comments we 
received on the proposed rule, we are not finalizing Sec.  482.43(d). 
We are redesignating the proposed requirement in Sec.  482.43(d)(3) as 
Sec.  482.43(b), and we are eliminating the specific timeframe 
requirements to require that hospitals discharge the patient, and also 
transfer or refer the patient where applicable, along with all 
necessary medical information pertaining to the patient's current 
course of illness and treatment, post-discharge goals of care, and 
treatment preferences, at the time of discharge, to the practitioners 
responsible for the patient's follow-up or ancillary care.
7. Transfer of Patients to Another Health Care Facility (Proposed Sec.  
482.43(e))
    We proposed to re-designate and revise the current standard 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. Therefore, we proposed, 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 directives, 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, we proposed that 
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. We also proposed to require hospitals provide this 
information at the time of the patient's discharge and transfer to the 
receiving facility.
    Comment: We received numerous comments regarding the requirement 
for hospitals and CAHs to provide specific information to a receiving 
facility during a transfer. While some commenters supported the 
proposed list of elements and offered suggestions for additional 
elements, most commenters believed that the list of required necessary 
medical information was overly prescriptive, excessively extensive, 
time consuming, duplicative, and burdensome. Some commenters stated 
that the extensive list would not improve the transition of patient 
care. Commenters suggested that the list be pared down or eliminated in 
favor of a clinical summary of a patient's hospitalization. Commenters 
recommended that specific information be determined by hospitals or 
CAHs and that only essential information be sent with the patient in 
the case of a transfer. One commenter recommended that CMS provide 
additional information on what constitutes sufficient information 
regarding certain medical information elements specified in the 
proposed rule including: Functional status, advance care plans, 
transportation needs, and risk assessment. Another commenter 
recommended that information regarding a patient's behavioral health 
issues include federally required preadmission screening for persons 
with serious mental illnesses or mental disabilities, as required for 
Medicaid Nursing home patients in section 1919(e)(7) of the Act.
    Several commenters expressed concern that the proposed requirements 
aligned with the Common Clinical Data Set defined in the 2015 Edition 
final rule and questioned the appropriateness of this alignment at this 
time, while other commenters supported the alignment. A few commenters 
had specific concerns about the inclusion of unique device 
identifier(s) for a patient's implantable device on the list of 
necessary medical information. While the commenters note their support 
of the use of the unique device identifier, they note that the required 
use at this moment is premature.
    Response: We continue to strive to promote successful transitions 
of care between health care settings and 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. 
Doing so will improve patient safety and potentially reduce hospital 
readmissions. Most providers recognize the importance of improving 
transitions of care between health care settings and several states and 
organizations have begun to develop, use, and recommend continuity of 
care documents or universal transfer forms. 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 (http://innovation.cms.gov/

[[Page 51859]]

initiatives/CCTP/index.html) and AHRQ as well as through a number of 
professional organizations, including the National Transitions of Care 
Coalition (www.ntocc.org). We refer readers specifically to the 
following information provided by AHRQ regarding care transitions:
     https://www.ahrq.gov/professionals/systems/hospital/engagingfamilies/strategy4/index.html.
     https://innovations.ahrq.gov/qualitytools/care-transitions-program-toolkit.
     https://caretransitions.org/tools-and-resources/.
     https://www.ahrq.gov/professionals/systems/hospital/red/toolkit/index.html.
    Therefore, we continue to believe that hospitals and CAHs should be 
required to send certain necessary medical information to a receiving 
facility upon a patient's transfer. However, we agree with commenters 
that mandating the various data elements listed in the proposed 
requirement may be burdensome to providers and may have the unintended 
effect of hindering a patient's discharge. However, while we are not 
requiring an extensive list of items as originally proposed, we still 
expect facilities to send certain necessary medical information that is 
critical to the care of the patient and pertinent to the patient's 
specific medical status at the time of discharge. We also believe 
facilities should have discretion to send the most relevant information 
within the required necessary medical information, consistent with 
``clinical relevance'' as defined in the Medicare and Medicaid 
Electronic Health Record Incentive Program final rule (80 FR 62761, 
October 16, 2015) (``2015 Meaningful Use Rule''). Other important and 
pertinent information that should be conveyed at discharge or transfer 
would be current diagnoses (including any behavioral health issues of 
mental health and substance abuse), laboratory results (including 
Clostridium difficile and multi-drug resistant organism status, as well 
as any antibiotic susceptibility testing, as applicable), and patient 
functional status, to name just a few broad areas of medical 
information that we believe are critical to patient care.
    Therefore, we are revising and relocating our proposed requirement 
from Sec.  482.43(e) to Sec.  482.43(b) in this final rule to require 
that a hospital must discharge the patient, and also transfer or refer 
the patient where applicable, along with all necessary medical 
information pertaining to the patient's current course of illness and 
treatment, post-discharge goals of care, and treatment preferences, at 
the time of discharge, to the appropriate post-acute care service 
providers and suppliers, facilities, agencies, and other outpatient 
service providers and practitioners responsible for the patient's 
follow-up or ancillary care.
    This modification aligns with our goals to promulgate CoPs that 
contain baseline requirements for providers that protect the patient's 
health and safety while allowing for provider flexibility and reducing 
unnecessary provider burden. While we continue to believe that much of 
the information we proposed should be exchanged for patients to whom it 
applies, as well as many of the additional suggestions we received, we 
are requiring a less prescriptive and more flexible set of 
requirements. We understand that the information required may vary 
based on the circumstances of a patient's discharge to home or transfer 
to another health care facility, including the urgency of the transfer.
    We note that providers can and should send all additional medical 
information pertaining to the patient's current course of illness and 
treatment, post-discharge goals of care, and treatment preferences. In 
addition, we expect that certain information, including a patient's 
goals and treatment preferences, be included in the patient's discharge 
or transfer summary and any other relevant documentation.
    We plan to issue sub-regulatory guidance that will discuss the 
circumstances of when a discharge or transfer summary would be expected 
at the time of discharge (and transfer if applicable), as in a 
discharge to home and community-based services (or a transfer to a PAC 
services facility such as a SNF), versus when it would not be 
appropriate to delay an emergency transfer as a result of waiting on 
the availability of a discharge summary. From our experiences with 
hospital and CAHs, we are also aware that there are instances when the 
discharge or transfer summary is delayed in being sent by the hospital 
or CAH due to the lack of a signature at the time of discharge by the 
practitioner responsible for the care of the patient. We note here that 
neither the current CoPs nor the revisions finalized in this rule 
prohibit hospitals and CAHs from sending an interim discharge or 
transfer summary document that would include the required necessary 
medical information to the appropriate post-acute care service 
providers and suppliers, facilities, agencies, and other outpatient 
service providers and practitioners responsible for the patient's 
follow-up or ancillary care so that such information can be shared 
timely, so that the discharge and/or transfer is not further delayed, 
and so that those facilities and practitioners responsible for the 
patient's follow-up or ancillary care are provided sufficient and 
necessary information and time to prepare to receive the patient. We 
would expect that a finalized document, even if not significantly 
different from the interim one, would follow the patient. Such 
practices are not only allowed under the CoPs, but also can be seen as 
constituting ``best practices'' for ensuring effective continuity of 
care for the patient transitioning from one care setting to another.
    Additionally, we would also like to point out that in those 
hospitals and CAHs where there are multiple licensed and qualified 
practitioners responsible for the care of the same patient, delay of 
the discharge, and transfer or referral where applicable, of the 
patient, along with his or her necessary medical information, should 
not occur as a result of ``waiting'' for a specific provider's 
signature, either written or electronic, on the discharge order and the 
discharge or transfer summary for the patient. The CoPs allow for 
orders and other forms of patient medical record information (for 
example, H&Ps, progress notes, discharge/transfer summaries, etc.) to 
be documented and signed by a licensed and qualified practitioner who 
is responsible for the patient as long as the practitioner is acting in 
accordance with all state and local laws, including scope-of-practice 
laws, as well as with all hospital and medical staff requirements and 
bylaws, and with any individual privileges granted to the practitioner 
by the governing body.
    While we have increased the flexibility in these requirements, we 
continue to support the alignment discussed in the proposed rule 
between this approach and the Common Clinical Data Set, which health 
care providers are electronically exchanging through the use of 
certified EHR technology (80 FR 62693). We encourage facilities to 
identify opportunities to streamline data collection and exchange by 
using data they are already capturing electronically. While we are 
finalizing a broad requirement for sending necessary medical 
information, rather than listing data elements, such as those 
explicitly aligned with the data referenced as part of the Common 
Clinical Data Set (CCDS) that was finalized in the 2015 Edition final 
rule (80 FR 62858), eligible hospitals and CAHs in the Promoting 
Interoperability Program are required under 42 CFR 495.4 to use EHR 
technology certified to the 2015 Edition

[[Page 51860]]

health IT certification criteria beginning in CY 2019 and are therefore 
required to provide the elements in the CCDS as part of a summary of 
care record (81 FR 77555). We note that by finalizing the requirement 
to release certain medical information in this final rule in accordance 
with all applicable laws, we are ensuring that the CoPs do not conflict 
with the CCDS. The CoPs do not bar providers from sending all 
additional appropriate medical information regarding the patient's 
current course of illness and treatment, post-discharge goals of care, 
and treatment preferences in accordance with applicable laws. We expect 
that certain information, including a patient's goals and treatment 
preferences, would be included in the patient's discharge summary and 
any other relevant documentation. As we note above, we plan to issue 
further sub-regulatory guidance that will discuss the circumstances of 
when a discharge summary or transfer summary would be expected at the 
time of discharge (and transfer if applicable). Furthermore, the 
interpretive guidelines for requirements in this final rule will be 
released sometime following the publication of this final rule, which 
will provide additional information regarding alignment with the CCDS, 
where applicable.
    Providers must continue to comply with all pertinent laws, 
including the HIPAA Privacy Rule and the behavioral health privacy 
regulations referenced by the commenter, as they implement these 
discharge planning requirements. Finally, we generally consider the 
exchange of information between facilities using an EHR system the same 
as ``sending'' information from one facility to another, except under 
those circumstances when we explicitly require use of a physical 
record. In fact, we expect that facilities, which are already 
electronically capturing patient health care information, are also 
electronically sharing that information with providers that have the 
capacity to receive it to the extent such release is permitted under 
HIPAA.
    Comment: One commenter recommended that CMS encourage, but not 
require, hospitals to send the discharge or transfer summary to PACs as 
far in advance as possible, while another commenter recommended that 
CMS make this a requirement. In addition, the commenter recommended 
that CMS mandate that the referring facility ensure that the receiving 
facility has received the information.
    Response: We agree that there are benefits to sending necessary 
medical information to post-acute care services providers as far in 
advance as possible and encourage hospitals to do so. However, we do 
not agree that this should be a requirement for all hospitals and CAHs. 
We also note that we are not requiring hospitals and CAHs to ensure 
that the receiving facility has received the information on a patient's 
discharge because such a requirement would be overly burdensome.
    Comment: A few commenters recommended that CMS delineate specific 
methods of communicating necessary medical information between the 
hospital and the PAC provider at the time of discharge. The commenters 
noted that designating a specific method will allow for seamless 
transmittal of data between settings
    Response: We are not requiring that hospitals and CAHs transmit 
necessary medical information in a specific manner at this time. 
However, we believe that it is absolutely important for PAC providers 
to receive information from hospitals and CAHs regarding a patient's 
vital and pertinent information, and we encourage hospitals and CAHs to 
send the information prior to discharge if at all possible and make the 
necessary revisions to allow for this as described previously. 
Furthermore, we encourage hospitals and CAHs to send this necessary 
medical information electronically, if the PAC provider has the 
capacity to receive it in this manner.
    Comment: One commenter requested that CMS create an exception for 
real time discharge summaries for transfers from acute care to SNF 
facilities. The commenter noted that while it is essential to know a 
patient's medical and treatment history, the discharge summary 
requirement does not make sense if information is being sent when the 
transfer is from the ``doctor to him or herself'' and from the ``nurse 
to the same nurse.'' The commenter further pointed out that this may be 
an issue in rural communities, where the practitioners are the same on 
either side of the transfer.
    Response: We understand the commenter's concerns about a repetitive 
or time consuming process for rural or small hospitals or CAHs, 
particularly when the services being provided to the patient changes 
from acute inpatient to swing bed. We note that the discharge planning 
process does apply to patients whose status changes from acute 
inpatient to swing bed services.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing Sec.  482.43(e) with 
modifications. We are revising and redesignating Sec.  482.43(e)(2) as 
follows:
     Removing proposed Sec.  482.43(c), (d), and (e) and 
replacing these standards with revised and redesignated Sec.  
482.43(b), entitled ``Discharge and transfer of the patient and 
provision and transmission of the patient's necessary medical 
information.'' The final standard at Sec.  482.43(b) incorporates and 
combines revised provisions from the proposed requirements at Sec.  
482.43(c), (d), and (e).
8. Requirements for Post-Acute Care (PAC) Services (Proposed Sec.  
482.43(f))
    We proposed to re-designate and revise the requirements of current 
Sec.  482.43(c)(6) through (8) at new Sec.  482.43(f), Requirements for 
PAC services. The proposed standard is based in part on specific 
statutory requirements located at sections 1861(ee)(2)(H) and 
1861(ee)(3) of the Act. We proposed to further clarify that the PAC 
providers mentioned in the IMPACT Act, specifically LTCHs and IRFs 
(rehabilitation hospitals and rehabilitation units of hospitals and 
CAHs), would also be subject to the proposed revision to the hospital 
CoPs in order to provide consistency with the IMPACT Act. We proposed 
that for patients who are enrolled in Managed Care Organizations 
(MCOs), the hospital must make the patient aware that the patient or 
caregiver needs 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 and 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.
    Comment: One commenter suggested that we require hospitals to 
communicate the capabilities and limitations of PAC facilities to the 
patient to ensure the patient receives the appropriate level of care as 
indicated in their discharge plan. The commenter further suggested that 
certain additional elements be considered, including limitations of the 
facility's number of RNs, Certified Rehabilitation Registered Nurse 
(CRRNs), physician availability, amount of therapy, and access to 
emergency services.

[[Page 51861]]

    Response: We understand that the commenter is concerned about 
meaningful and successful transitions of care between the hospital and 
PAC settings. However, we do not believe it is appropriate to add 
language requiring hospitals to communicate the capabilities and 
limitation of PAC facilities to the patient and/or their caregivers, as 
this would be duplicative of the requirement at proposed Sec.  
482.43(c)(8), now finalized at Sec.  482.43(a)(8). We believe this 
requirement for sharing and using PAC data with patients sufficiently 
addresses the commenter's concerns.
    Comment: Several commenters requested that we design a process or 
tool to allow for rapid identification of appropriate PAC 
organizations, including those that are in the patient's managed care 
network, to speed up the discharge process. One commenter recommended 
that CMS require insurance companies to have an updated list of 
providers and rating qualities and cost efficiency data so that 
providers can refer patients to their insurance companies for this 
information. One commenter stated that obtaining a list of Medicare-
certified providers was challenging and that information regarding the 
providers was not always up to date.
    Response: We would allow a hospital the flexibility to implement 
the requirement to present its list of HHAs, SNFs, IRFs, or LTCHs in a 
manner that is most efficient and least burdensome in its particular 
setting. For HHA, SNF, and dialysis services, a hospital can access a 
list from the CMS website, at http://www.medicare.gov, or develop and 
maintain its own list of HHAs and SNFs. We expect that providers have 
the most current list of providers that is available to them at the 
time. When the patient requires home health services, the CMS website 
list can be accessed based on the geographic area in which the patient 
resides. When the patient requires post hospital extended care 
services, the CMS website list would be accessed based on the 
geographic area requested by the patient. Or, in the rare instance when 
a hospital does not have internet access, the hospital can call 1-800-
MEDICARE (1-800-633-4227) to request a printout of a list of HHAs or 
SNFs in the desired geographic area. Information on this website should 
not be construed as an endorsement or advertisement for any particular 
HHA or SNF. For IRFs and LTCHs, we expect that hospitals maintain a 
list of their own, based on geographic location of the facilities. If a 
hospital chooses to develop its own list of HHAs, SNFs, IRFs, and 
LTCHs, the hospital would have the flexibility of designing the format 
of the list. However, the list should be utilized neither as a 
recommendation nor endorsement by the hospital of the quality of care 
of any particular HHA, SNF, IRF, or LTCH. If an HHA, SNF, IRF, or LTCH 
does not meet all of the criteria for inclusion on the list (Medicare-
certified and is located in the geographic area in which the patient 
resides or in the geographic area requested by the patient), we do not 
require the hospital to place the entity on the list. We expect that 
hospitals share their data sources with the patients or the patient's 
representatives and explain the meaning of the data as they are 
presented to them.
    Except as specified by statute, CMS lacks the authority to require 
insurers, health plans, or plan sponsors to meet CMS's regulatory 
requirements. Because the discharge planning requirements have no 
provisions regarding health plans, health insurers, or plan sponsors, 
comments related to potential requirements for insurers are outside the 
scope of this final rule.
    Comment: Numerous commenters made suggestions regarding the list of 
PAC providers that must be provided to patients. One commenter stated 
that we should require that the list of PAC providers given to patients 
include all available PAC providers, as a means to eliminate potential 
bias in favor of PAC providers who may have a close relationship with 
the hospital. Several commenters expressed concern with the requirement 
that HHAs must request to be listed by the hospitals as available, as 
this is seen as limiting the options presented to patients. One 
commenter stated that it is common practice for hospitals to first 
require PAC providers to indicate they will accept a particular patient 
in order to be included in the list of PAC providers that is presented 
to the patient. The commenter states that hospitals frequently present 
to the patient only the PAC providers that responded favorably within a 
given timeframe that they will accept the patient, even if only a 
limited number of providers responded to the request. Commenters 
recommended that the regulation be modified to include hospice among 
the post-hospital care providers where a list of hospices is made 
available to the patient, along with the other protections on the 
patient's freedom of choice. Another commenter stated that hospitals 
should be required to provide lists of all providers and services 
available to patients upon discharge.
    Response: We proposed at Sec.  482.43(f)(1) to require hospitals 
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 case of a SNF, IRF, or 
LTCH, in the geographic area requested by the patient. This allows the 
patient to identify the geographic area in which they would like the 
SNF, IRF, or LTCH to be located. Given that this process is patient-
driven, it eliminates the risk of hospital bias in the patient's 
selection of one of these PAC providers. In addition, providing 
patients with a list of providers that responded within an allotted 
period of time would not assist the patient in making a decision, as it 
may unduly limit patient choice based on an arbitrary time deadline. 
While hospitals may have working relationships with some PAC providers, 
hospitals are expected to present patients with a list of providers 
that meet the proposed requirements of Sec.  482.43(f)(1). We expect 
discharge planning to facilitate patient choice in any post hospital 
extended care services, even though the statute does not require a 
specific list beyond HHAs, SNFs, IRFs, and LTCHs. The proposed 
requirement at Sec.  482.43(f)(2) is also important because it requires 
the hospital, as part of the discharge planning process, to 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. We do encourage hospitals to provide any 
information regarding PAC providers that provide services that meet the 
needs of the patient. Hospitals must not develop preferred lists of 
providers. If the hospital has information regarding a PAC provider's 
specialized services, we encourage that this information be provided to 
the patient as well as any culturally specific needs that the PAC 
providers are able to address (for example, the patient's foreign 
language needs, and their cultural dietary needs or restrictions).
    Section 4321(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33), codified as 1861(ee)(2)(D) of the Act, provided that the 
hospital discharge planning evaluation include an evaluation of the 
patient's likely need for post-hospital services and the availability 
of those services, ``including

[[Page 51862]]

the availability of home health services through individuals and 
entities that participate in the program under this title and that 
serve the area in which the patient resides and that request to be 
listed by the hospital as available.'' We have interpreted this 
provision to require that hospitals need only indicate the availability 
of home health services provided by HHAs that request to be listed in 
the discharge plan, as opposed to the universe of individuals and 
entities that participate in the program. We believe that our 
interpretation is consistent with the BBA provision. We believe that 
the request to be listed protects HHAs from the possibility that a 
hospital or other acute care provider would misstate the HHAs service 
area.
    Lastly, the provisions of the IMPACT Act apply to certain PAC 
providers only, including HHAs, SNFs, IRFs, and LTCHs. Although we 
proposed to modify this currently existing requirement to include IRFs 
and LTCHs, in order to be consistent with the provisions of the IMPACT 
Act, we expect the discharge planner to facilitate patient choice in 
any post hospital extended care services as part of the discharge 
planning process.
    Comment: One commenter stated that it would be helpful if patients 
and their caregivers were provided information regarding the out-of-
pocket costs for the different PAC providers.
    Response: This comment does not pertain to any specific proposed 
changes to the discharge planning policy proposals set forth in the 
Discharge Planning proposed rule. Calculating out-of-pocket costs for 
beneficiaries is outside the scope of this rulemaking.
    Comment: One commenter stated that hospitals should be required to 
document the actual list of post-acute care referrals presented to the 
patient as a means for surveyors to determine the adequacy of the post-
discharge options presented to the patient.
    Response: We agree with the need to ensure that surveyors 
appropriately determine that hospitals are providing patients referred 
to HHAs, SNFs, IRFs, or LTCHs a list of providers that contains 
appropriate and sufficient options in accordance with this requirement. 
We think it is important to allow hospitals the flexibility to 
determine the manner in which they document in the patient's medical 
record that the list of PAC providers was presented to the patient or 
to the patient's representative. We expect that surveyors will ask to 
see this documentation as part of the survey process.
    Comment: Most commenters agreed with the proposal to require that 
hospitals provide patients with information on which practitioners, 
providers or certified supplies are in the network of the patient's 
managed care organization if the hospital has this information. Several 
commenters stated that information regarding providers and suppliers 
within a patient's managed care network was not readily available. 
Commenters also stated that confirming a patient's managed care network 
is the responsibility of the patient and to some extent the 
responsibility of the patient's health plan. Commenters found that it 
is reasonable for hospitals to use limited resources to assist certain 
patient populations with obtaining the patient's managed care network 
information and connecting with their managed care network such as 
those who naturally have difficulty navigating the healthcare system 
(such as those with behavioral health conditions or limited English 
proficiency). In addition, commenters stated that requiring hospitals 
to obtain and share this information is labor-intensive and recommend 
that we require PAC providers to disclose their managed care network to 
the hospital upon being contacted for patient referrals.
    Response: We proposed that hospitals be required to make the 
patient aware that the patient or caregiver needs 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; however, the hospital is not expected to have the latest 
information, as only the MCO would have this information. While we 
understand that in some cases, information regarding a patient's 
managed care network is not available to the hospital, we encourage the 
hospital to make a reasonable effort to obtain this information 
regarding a particular post-acute care provider, especially if 
requested by the patient or for vulnerable patient populations as 
identified by the hospital in the hospital's discharge planning policy. 
It should also be noted that we encourage hospitals to work 
collaboratively with insurance companies to ensure that the hospital 
has up-to-date information; this requirement is not intended to be an 
unreasonable burden on hospitals, but merely another factor in helping 
patients select the right post acute facility for them. While obtaining 
this information may be burdensome to the hospital in cases when it is 
not readily available, doing so is in the best interest of the patient 
so that the patient is able to obtain the referred post-acute care 
services. If the patient wishes to receive services from an in-network 
PAC provider, but there are none available in the patient's geographic 
area or the area requested by the patient, we encourage the hospital to 
assist the patient or the patient's representative in identifying in-
network PAC providers that are able to provide services to the patient. 
We expect the hospital to address in its discharge planning policy 
cases in which there are no PAC providers within a patient's managed 
care network, to the extent that this information is known.
    The hospital is required to provide patients with a list of PAC 
providers that serve the geographic area in which the patient resides, 
or in the case of SNFs, IRFs, and LTCHs, in the geographic area 
requested by the patient, and to inform the patient which providers are 
in the patient's managed care network to the extent that the hospital 
has this information, as previously described. In this way, patients 
will be provided with a complete list of PAC providers and the 
information available on which of these providers are in their managed 
care network. The hospital has the flexibility to determine the manner 
in which it meets the requirement to inform the patient. It should be 
noted that there may be cases in which the patient selects a post-acute 
care provider that is not in their managed care network (for example, 
if the patient is paying out of pocket for the post-acute care 
services). Requiring PAC providers to disclose their managed care 
network to the hospital upon being contacted for patient referrals is 
outside of the scope of this rulemaking; however, we do encourage 
hospitals to work with the PAC providers in their geographic area to 
develop a system that will allow hospitals to efficiently identify 
whether a listed post-acute care provider is part of the patient's 
managed care network.
    In addition, there may be cases in which post-acute care services 
are not recommended, but the patient wishes to obtain these services 
and cover the costs out of pocket. In these cases, we expect that the 
hospital will provide a list of PAC providers that are available to 
provide the services requested by the patient.
    Additional information regarding enforcement of this requirement 
will be provided in the interpretive guidelines.
    Comment: One commenter stated that providing a list of PAC 
providers to parents or patient representatives of pediatric patients 
is inappropriate for

[[Page 51863]]

use in identifying care for the pediatric population. The commenter 
stated that there are a limited number of PAC providers that treat this 
population.
    Response: We would not expect hospitals to provide patients or 
their representative with a list of PAC providers that do not provide 
services that will meet the needs of the patients. For example, we 
would not expect that a pediatric patient who is being discharged from 
the hospital and referred for home health services would be presented a 
list of HHAs that do not provide services to pediatric patients.
    Comment: Several commenters requested that we implement further 
requirements that specifically address delays in the discharge process 
for patients being referred for post-acute care services related to 
authorization for services, timely acceptance of patients by the PAC 
provider, and current payer contracts. Commenters stated that there are 
sometimes significant delays in the discharge process for patients 
referred for post-acute care services as a result of timely process for 
authorization for services for which preauthorization is often 
required. Commenters also stated that hospitals have little control 
over the time it takes for PAC providers to accept patients once they 
have been notified of the need for services. One commenter submitted a 
question regarding a scenario where a patient is ready for discharge 
and a bed is available at a Medicare sub-acute rehabilitation facility 
in the geographic area of the patient's choice. The commenters also 
asked if the patient chooses a higher rated sub-acute rehab facility 
that does not have a bed available, can the hospital issue a Hospital-
Issued Notice of Noncoverage (HINN-12) to the patient.
    Response: One of the goals of this rule is to prevent any undue 
delays in the patient discharge process. We understand that delays in 
the discharge process will still occur for patients for factors that 
are beyond the hospital's control. In such cases, any delays in the 
discharge process will not be attributed to the hospital.
    The comments regarding the management and oversight of managed care 
networks and the current payer contracts and those regarding notices of 
noncoverage do not pertain to any specific proposed changes to the 
discharge planning policy proposals set forth in the Discharge Planning 
proposed rule. These matters are outside the scope of this rulemaking.
    Comment: Commenters supported the proposal to require the discharge 
plan to identify any HHA or SNF to which the patient is referred in 
which the hospital has disclosable financial interest. Commenters 
requested that we discuss what level of disclosure must be provided and 
offer some standard language for providers' use. One commenter asserted 
that a beneficiary may give priority during the discharge planning 
process to a provider or supplier related financially to the hospital 
if he or she had a good experience with the discharging hospital. The 
commenter recognized that, unless an exception applies and its 
requirements are satisfied, section 1877 of the Act (the physician 
self-referral law) prohibits referrals of designated health services by 
physicians who have financial relationships with entities that furnish 
such services. Because many post-acute providers and suppliers furnish 
designated health services (which include home health services, 
physical therapy services, occupational therapy services, and speech 
language pathology services, among others), the commenter recommended 
CMS consider providing guidance to hospitals regarding how to conduct 
discharge planning activities required under the CoPs in compliance 
with the physician self-referral law. As an example, the commenter 
noted the need for hospital discharge planning staff to be aware of 
both the hospital's financial interest in an HHA to which a patient is 
being referred, as well as whether the ordering physician has a 
financial relationship with the home health agency that implicates the 
physician self-referral law.
    Response: We appreciate the support for the proposed regulations. 
If a hospital referred patients about to be discharged and in need of 
post-hospital services only to entities it owned or controlled, the 
hospital should disclose this information so the patient has all of the 
information needed to choose the facility he or she would like to visit 
for services. The proposed disclosable financial interest requirement 
is an effort to increase the beneficiary's awareness of the actual or 
potential financial incentives for a hospital as a result of the 
referral. To allow hospitals the flexibility of determining how these 
financial interests are disclosed to the patient, we did not propose to 
require a specific form or manner in which the hospital must disclose 
financial interest. The hospital could simply highlight or otherwise 
identify those entities in which a financial interest exists directly 
on the HHA and SNF lists or the hospital could choose to maintain a 
separate list of those entities in which a financial interest exists.
    We provide guidance regarding the physician self-referral law on 
the CMS website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/index.html?redirect=/PhysicianSelfReferral/. 
Outside of the advisory opinion process described at Sec. Sec.  411.370 
through 411.389, we are unable to provide specific guidance regarding 
the compliance with the physician self-referral law of any particular 
hospital, post-acute provider or supplier, or referring physician.
    Final Decision: After consideration of the comments we received on 
the Discharge Planning proposed rule, we are finalizing proposed Sec.  
482.43(f) at Sec.  482.43(c) without modification.

F. Home Health Agency Discharge Planning (Proposed Sec.  484.58)

    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 beneficiaries 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.
    The current regulations at Sec.  484.110 require HHAs to provide a 
copy of the discharge summary to the follow-up care provider. We 
proposed to update the discharge summary requirements by requiring that 
HHAs better prepare patients and their caregiver(s) 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. In Sec.  484.58, 
we proposed to require that HHAs develop and implement an effective 
discharge planning process that focuses on the following:
     Preparation of patients and caregivers 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 the Discharge Planning proposed rule (80 FR 68137), we also 
addressed the content and timing requirements for the discharge or 
transfer summary for HHAs. These proposed changes incorporated the 
requirements of the IMPACT Act. In addition, we solicited

[[Page 51864]]

comments on the timeline for HHA implementation of the proposed 
discharge planning requirements. We discuss the comments we received in 
response to this solicitation of comments in section II.B of this final 
rule.
1. Discharge Planning Process (Proposed Sec.  484.58(a))
    We proposed 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 proposed 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 would be updated, as needed, 
to reflect these changes.
Proposed Sec.  484.58(a)(1) Through (7)
    We proposed at Sec.  484.58(a)(1) to require that the discharge 
planning process include re-evaluation of patients to identify changes 
that require modification of the discharge plan, in accordance with the 
timeframes for updating the patient assessment as set forth at Sec.  
484.55. We proposed that the discharge plan would be updated, as 
needed, to reflect these changes. We proposed at Sec.  484.58(a)(2) 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 proposed at Sec.  484.58(a)(3) to require that the HHA consider the 
availability of caregivers 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. We proposed at Sec.  
484.58(a)(4) to require that the patient and caregiver(s) must be 
involved in the development of the discharge plan, and informed of the 
final plan. Furthermore, in order to incorporate patients and their 
families in the discharge planning process, we proposed at Sec.  
484.58(a)(5) to require that the discharge plan address the patient's 
goals of care and treatment preferences.
    For those patients who are transferred to another HHA or who are 
discharged to a SNF, IRF, or LTCH, we proposed at Sec.  484.58(a)(6) 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.
    As required by the IMPACT Act, HHAs must take into account data on 
quality measures and resource use measures during the discharge 
planning process. We also proposed at Sec.  484.58(a)(6) 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. We received many public comments on these 
proposed requirements for HHAs and we refer readers to section II.F of 
this final rule for a summary of those comments and our responses.
    In addition, we proposed at Sec.  484.58(a)(7) 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. We also proposed to require that 
the evaluation be included in the clinical record. We proposed 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.
    Comment: Several commenters strongly supported the proposed 
requirements at Sec.  484.58, ``Discharge Planning.'' Commenters stated 
that these new requirements put patients and their needs at the center 
of the discharge process. They also stated that standardization would 
improve the process of transitioning between care settings, reduce 
patient confusion, and improve compliance with discharge instructions. 
Additionally, other commenters were pleased to see the requirement to 
ensure that the discharge goals, preferences, and needs of each patient 
are identified. Other commenters requested specific clarifications of 
potentially ambiguous terms, such as ``active partner,'' ``preventable 
readmissions,'' and ``effective transfers.'' However, many commenters 
expressed concern regarding the burdens that would be imposed upon 
HHAs, should the proposed requirements become final, particularly 
because they believe there is no evidence that engaging in the 
extensive discharge process that we proposed would improve patient 
safety, HHA-physician communications, or post-HHA care delivery. The 
proposed role of the physician in discharge planning was of particular 
concern to many commenters. Some commenters supported the idea of 
involving the physician, but stated that they believed that in most 
instances the HHA would be in a better position to develop the 
patient's discharge plan because physicians are not always familiar 
with the community resources available in the communities that serve 
their patient. Commenters requested flexibility in the degree of 
physician involvement in establishing the discharge plan of care. In 
addition, many commenters did not support the proposed requirements. 
Commenters stated that if the provision were finalized as proposed, it 
would require a substantial amount of communication time for both HHAs 
and physicians, imposing significant burden upon both entities. HHAs 
voiced concern with the involvement of primary care physicians, whom 
they believe are often difficult to contact, and whom they believe do 
not want to be involved with a patient's home health care if ordered by 
a different physician. Commenters recommended that only a discharge 
order from the primary care physician be required, and that the 
physician should receive a copy of the discharge summary to follow-up 
with the patient as appropriate. Another commenter suggested that the 
proposed language be modified to allow physician discretion as to their 
involvement in the discharge planning process. Additionally, a 
commenter suggested that with the increasing number of ``patient-
centered medical home'' situations, the person most suitable to be 
involved in the home health discharge planning would not be a 
physician, but rather a case manager, care coordinator or mid-level 
provider working under the overall direction of a physician.
    Response: While we appreciate the support for this proposed 
requirement, we are sensitive to the burden and practicality concerns 
raised by commenters. It was not our intent to impose a process that 
may not align with current HHA processes or may be otherwise unduly 
burdensome. It was also not our intent to potentially strain HHA-
physician relationships. We agree that this issue warrants further 
study and a better developed evidence base before we proceed further 
with rulemaking. We also agree that the proposed terminology lacked 
clarity in a manner that could make surveying for compliance difficult 
and potentially inconsistent.
    Additionally, many of the areas addressed in the proposed HHA 
discharge planning requirements were

[[Page 51865]]

subsequently addressed in a January 13, 2017 final rule in the Federal 
Register, titled ``Medicare and Medicaid Program: Conditions of 
Participation for Home Health Agencies'' (82 FR 4504), referred 
hereinafter as ``HHA CoP final rule'', creating concerns regarding 
potential regulatory duplications that should be avoided. For example, 
the final HHA CoP final rule requires HHAs to communicate with all 
relevant parties, including physicians who are involved in the 
patient's HHA plan of care, whenever there are revisions related to the 
plan for patient discharge (Sec.  484.60(c)(3)(ii)). We believe that 
this requirement, which was put into place following publication of the 
Discharge Planning proposed rule, accomplishes the goal of HHA-
physician communication regarding discharge. As such, we believe that 
this separate discharge planning requirement is no longer necessary, 
and we are withdrawing the proposal at Sec.  484.58(a)(2) 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 
are also withdrawing the majority of the other general discharge 
planning requirements proposed in Sec.  484.58(a), with the exception 
of those IMPACT Act requirements set forth in proposed paragraph 
(a)(6). We are committed to working with stakeholders to identify 
specific needs and concerns regarding discharge planning in the HHA 
care setting that may warrant future efforts, and to explore all 
options for achieving positive patient outcomes.
    Comment: Commenters supported CMS's proposal that, for those 
patients who are subsequently transferred from a HHA to another HHA, 
SNF, IRF, or LTCH, the HHA should help patients assess the available 
providers.
    Response: We appreciate the support for the requirement that HHAs 
assist patients when transferring to another post-acute care provider. 
We believe that recognizing patient preferences and assisting the 
patient with transfer options will support communication between the 
patient and the HHA, ultimately supporting patient informed decision 
making and improving patient care and satisfaction. We are finalizing 
this requirement as part of a more abbreviated discharge planning 
requirement at Sec.  484.58(a).
    Comment: A few commenters stated that the proposed rule does not 
adequately inform individuals of the full scope of their rights related 
to discharge and that the proposed regulation should present the 
discharge requirements in terms of patient rights. Other commenters 
believe CMS should have added several of the provisions under the 
hospital Discharge Planning proposed rules to the home health proposed 
requirements. Some of the additional requirements the commenter 
suggested include:
     Require the HHA to specify who should be involved in 
designing, developing and coordinating the discharge planning process; 
and to involve social work staff and patient and family 
representatives.
     Assess a family caregiver's/support person's willingness 
to provide care.
    Response: We appreciate the comments regarding HHA patient rights 
as related to the discharge process. We addressed patient rights in the 
HHA CoP final rule, which expanded our Patient Rights CoP. We believe 
that this Discharge Planning final rule, when combined with the 
requirements located in the HHA CoP final rule, adequately addresses 
the patient's right to be fully involved in all aspects of care 
planning, including the discharge plan, to the extent that the 
individual patient desires. This Discharge Planning final rule sets out 
the obligations of the HHA to both provide information to patients for 
selecting additional post-acute care services, and to provide important 
patient care-related information to follow-up care providers. As 
described earlier, we are not finalizing the proposed discharge 
planning process requirements of Sec.  484.58(a), with the exception 
for those IMPACT Act requirements set forth in proposed paragraph 
(a)(6). As this requirement is not being finalized, it is not 
appropriate to specify those disciplines that must be involved in 
developing the process within each HHA. With regard to the suggestion 
that CMS should mandate that HHAs assess a family caregiver's/support 
person's willingness to provide care, this issue was also addressed in 
the HHA CoP final rule (82 FR 4530 and 4581). In the HHA CoP final rule 
we implemented a new requirement that HHAs must assess a caregiver's 
willingness and ability to provide care as part of the comprehensive 
patient assessment.
    Comment: Some commenters recommended that CMS require HHAs to 
ensure that the patient and caregiver receive discharge education and a 
copy of the discharge summary. Commenters also suggested that CMS 
should mandate the content of discharge instructions, including contact 
information for the receiving practitioner, information regarding 
follow-up appointments, medication schedule and instructions to 
specific care needs and treatment, and contact information for the HHA 
clinical manager.
    Response: With regard to the suggestion that CMS should mandate 
what discharge instructions must include, we agree, and as part of the 
HHA CoP final rule, we require that HHAs provide patients with key 
information, such as information regarding medications and services 
provided, throughout the patient's duration of home health care (Sec.  
484.60(e)). We also require at Sec.  484.60(d)(5) that HHAs ensure that 
patients and caregivers receive ongoing education and training 
regarding the care and services identified in the plan of care. The HHA 
must provide training, as necessary, to ensure a timely discharge. This 
ongoing information to educate and engage patients in their care is 
designed to ensure patient activation during home health care and 
prepare patients for discharge by ensuring that patients and caregivers 
have the necessary knowledge and skills to continue performing 
necessary tasks after HHA discharge. In light of these requirements, we 
do not believe that it is necessary to duplicate requirements for 
discharge instructions.
    Comment: A few commenters suggested that HHAs should be required to 
have a post discharge follow-up process when home health services end.
    Response: Post discharge activities by a discharging HHA are not 
covered services under Medicare. As a result, CMS cannot make this a 
requirement; however, there is nothing to prevent the HHA from adding a 
post discharge follow-up process for patients as part of their own 
discharge process.
    Comment: One commenter supported the proposal that requires HHAs to 
evaluate and revise a patient's discharge plan as needed, and 
recommended that the timeline for revisions to a discharge plan should 
be determined by each individual HHA. Conversely, another commenter 
stated that while they understood the intent behind the proposed 
language to revise the plan, it would not be realistic because there 
are many cases where the patient's condition changes quickly and 
dramatically without warning. According to the commenter, revising a 
discharge plan based on such a change, which could be temporary, would 
be wasteful. The commenter instead recommended requiring HHAs to 
cooperate with inpatient facilities requiring information about 
patients receiving emergency or unplanned inpatient care when 
contacted, or if agency personnel were aware a contact was planned or 
occurring.

[[Page 51866]]

    Response: We thank the commenters for their comments on discharge 
planning. We agree that the proposed time frame may have been 
unrealistic in certain cases. Regarding the commenter's concerns of 
inappropriately using resources to begin discharge planning too early 
in the care timeline, we also believe that requiring a specific 
timeframe for initiating discharge planning in the HHA environment may 
result in an inefficient, overly burdensome regulation. Therefore, we 
are not finalizing the proposed requirement to update the discharge 
plan each time the patient assessment is updated in accordance with the 
requirements of Sec.  484.55(d). We will continue to monitor the 
available evidence regarding HHA discharge planning, and may reconsider 
the issue of discharge planning timeframes in the future. We agree that 
HHAs should provide necessary information to transfer providers. This 
requirement is already included in the clinical records requirement of 
the HHA CoPs at Sec.  484.110(a)(6).
    Comment: One commenter requested that we clarify that one way HHAs 
could demonstrate compliance with the proposed requirement to involve 
physicians in discharge planning is by documenting any outreach to the 
physician to coordinate his or her involvement.
    Response: In light of the burden and practicality concerns 
described by commenters, we are not finalizing the requirements 
originally proposed at Sec.  484.58(a)(2). In accordance with the 
requirements of the HHA CoP final rule at Sec.  484.60(c)(3)(ii), HHAs 
must communicate with all physicians who are involved in the patient's 
HHA plan of care whenever there are revisions related to the plan for 
patient discharge. We agree with the commenter that one way the HHA can 
demonstrate compliance is to document the HHA's outreach to the 
physician(s) involved.
    Comment: A few commenters requested that the HHA requirements 
mirror the hospital discharge requirements to the extent reasonable. 
The commenter stated the hospital CoP proposed language at Sec.  
482.43(c)(1), requires that a ``registered nurse, social worker, or 
other qualified personnel must coordinate the discharge needs 
evaluation and development of the discharge plan.'' The commenters 
recommend that a comparable requirement be included in the HHA CoPs, as 
it would help clarify the respective roles of HHA staff and the 
patient's physician.
    Response: We appreciate the commenter's suggestion. Section 
484.105(c) of the recently implemented HHA CoP final rule requires each 
HHA to have one or more clinical managers with responsibility for, 
among other things, coordinating patient care, making referrals, 
assuring that patient needs are continually assessed, and assuring the 
development, implementation, and updates of the individualized plan of 
care. Section 484.60(c) includes the discharge plan as part of the 
overall plan of care. Therefore, the current rules already require a 
clinical manager, who may be a physician, nurse, or licensed therapist, 
to be responsible for the discharge plan.
    Comment: We received one comment related to the proposed language 
regarding caregiver support. The commenter stated that the HHA's 
primary consideration with regard to family caregivers is their 
willingness to provide services to an ill, disabled or frail elderly 
individual. The commenter went on to state that there needs to be 
consideration of whether the caregiver is able to provide the care, 
especially given other factors such as the caregiver's age and other 
possible limitations. The commenter recommended that CMS consider 
requiring health care providers to engage in a conversation and 
subsequently document that a family caregiver understands the follow-up 
services that will be most critical to the patient, is able and willing 
to assist with the provision of care, as well as what specific supports 
the family caregiver requests and needs. The commenter further 
recommended that, in discussions of what support a family caregiver may 
need, his or her economic resources should be taken into account.
    Response: Issues of caregiver willingness and ability are already 
addressed as part of the comprehensive assessment requirements at Sec.  
484.55(c)(6). Additionally, HHAs must include caregiver education and 
training as part of the plan of care (Sec.  484.60(a)(2)(xiii)) and 
must provide that training (Sec.  484.60(d)(5)). We believe that these 
ongoing efforts to educate, train, and otherwise engage caregivers 
throughout the continuum of HHA care meet the needs of caregivers in 
preparing for discharge. Furthermore, in this rule we are finalizing a 
requirement that HHAs must provide necessary medical information to 
post-HHA care providers to ensure the safe and effective transition of 
care that supports the post discharge goals for the patient. The 
sharing of this information will facilitate identification of needs and 
preferences moving forward in the next care setting.
    Comment: One commenter stated that the regulation should be 
specific in requiring that the updates envisioned in Sec.  484.58(a)(1) 
include re-checking goals and preferences of the patient. Proposed 
Sec.  484.58(a)(4) would require that the patient be informed of the 
``final'' plan, and the commenter suggested that the patient should be 
informed of every version of the plan. Additionally, the commenter 
suggested that the regulation should require that the patient not only 
be informed of the discharge plan, but also be given a copy of the 
discharge plan and each revision.
    Response: We appreciate the commenter's suggestions related to 
discharge plan updates and the rechecking of patient goals and 
preferences. Section 484.60(c)(3)(ii) of the current HHA CoPs require 
that any revisions related to plans for the patient's discharge must be 
communicated to the patient, representative, caregiver, all physicians 
issuing orders for the HHA plan of care, and the patient's primary care 
practitioner or other health care professional who will be responsible 
for providing care and services to the patient after discharge from the 
HHA (if any). We believe that this existing requirement for regular 
communication accomplishes a similar goal without being overly 
prescriptive regarding the format of communications. Therefore, we are 
not finalizing any additional regulations for this topic.
    Comment: One commenter requested clarification regarding the term 
``clinical record.'' The commenter asked if the term ``clinical 
record'' is broader than the term ``medical record.'' The commenter 
also asked if this would include everything that would also be part of 
the ``medical record,'' and recommended that the final regulation 
substitute the term ``individual's medical record'' in place of 
``clinical record'' for consistency.
    Response: The term ``clinical record'' is the current language that 
is used in the HHA CoPs and is not broader than the term ``medical 
record.'' We use the terms interchangeably as they relate to HHAs.
    Final Decision: After consideration of the comments we received on 
the proposed discharge planning rule, we are not finalizing the 
requirements set forth in proposed Sec.  484.58(a), with the exception 
of those IMPACT Act requirements set forth at proposed paragraph 
(a)(6). The IMPACT Act requirements are being finalized at Sec.  
484.58(a).

[[Page 51867]]

2. Discharge or Transfer Summary Content (Proposed Sec.  484.58(b))
    We proposed 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.
    We proposed to include these elements in the discharge plan so that 
there would be 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 solicited comments on these proposed medical information 
requirements.
    Comment: We received many comments related to the content of the 
discharge summary; however, there was a wide range of suggestions on 
what type and how many elements should be included in the summary. 
Below is a summary of the different suggestions commenters made:
    Items to be added to the summary:
     Caregiver name, contact information, and capacity.
    Items to be eliminated from the summary:
     Laboratory and diagnostic tests and results: They would 
not typically be part of the home health medical record. This 
information would be part of the medical record for the entity that 
ordered the services.
     Unique Device Identifier: The HHA would not likely have 
this information. This information would be part of the medical record 
where the device was implanted.
     Consultation with a state's Prescription Drug Monitoring 
Program (PDMP): Some states do not have a PDMP and it is not clear what 
practitioners would/could have access to this data base. Practitioners 
with drug prescribing privileges are the only people who might find 
value from a PDMP.
    Items to include in the discharge summary only if the HHA performed 
or facilitated (or otherwise could transmit the information without 
additional activity):
     Consultation results and procedures: Only require 
inclusion of consultations and procedures that the HHA performed. The 
HHA would not have as part of their medical record consultation results 
and procedures performed by other facilities.
     Immunization: Only require reporting immunizations the HHA 
has provided.
    Items to revise:
     Smoking status: Modify to include reporting of any 
significant adverse health behaviors rather than limiting the 
information to smoking.
     Any other information necessary: This provision should add 
``as determined necessary by the HHA.''
     Current care plan, including goals and latest physician 
orders: The commenters noted that the proposal seemed redundant with 
the following required elements:
    ++ Course of illness/treatments.
    ++ Patient's goals and treatment preferences.
    Items to be added:
     Diet.
     Name of the provider (facility, physician and advanced 
practice nurse) who will continue to provide care following discharge 
from home health care.
     Contact information for the HHA that provided the care.
     Name of any community-based social service provider known 
to be continuing service for the patient or from whom the patient may 
seek future assistance, such as Meals-on-Wheels, companion programs, 
housing programs, etc.
     Information on upcoming health-related appointments. These 
would include, but not be limited to, physician appointments, community 
social services and supports (for example, Meals-on-Wheels), non-
medical home health, adult day care, outpatient therapy, and mental 
health follow-up appointments.
     Pharmacy, DME/oxygen, emergency response system or other 
vendor contact information (contact persons' names, phone numbers, and 
fax numbers).
     Instructions for patients and caregivers on what to do if 
unexpected symptoms or events occur. It may involve contacting a 
physician or behavioral health counselor or calling the home health 
agency office.
    Furthermore, many commenters questioned the usefulness of much of 
the proposed minimum information that would be included in the transfer 
or discharge summary, as compared to the burden of compiling all of the 
required information. A few commenters stated that the intent of the 
discharge summary was good; however, there should be some allowances 
for the clinician to be able to give a succinct picture of the patient 
condition. Commenters stated that these requirements will take time to 
compile, delaying the ability to summarize pertinent succinct 
information timely. Other commenters stated that CMS should develop 
streamlined alternatives to the proposals, particularly the discharge 
summary requirements. Another commenter requested clarification as to 
whether CMS would only require that HHAs provide discharge or transfer 
summaries to other providers, not patients. It was suggested that CMS 
require the information be sent to the physician responsible for the 
home health plan of care, in addition to the receiving facility or 
health care practitioner, which would ensure that the physician who 
established the home health plan of care has information to continue to 
be involved in the patient's care at a later time, as necessary. 
However, another commenter believed it may not be necessary to forward 
such information to the health care practitioner. The commenter 
recommended that the language be changed to reflect that the 
information be sent to the receiving facility and made available, upon 
request, to the health care practitioner.
    Response: We appreciate the wide array of comments related to the

[[Page 51868]]

proposed requirement at Sec.  484.58(b). The disparate nature of the 
comments lead us to conclude that, at this time, there is no clear 
consensus regarding the minimum information that should be shared from 
one HHA to another health care provider in order to assure patient 
health and safety. We also note that there is a lack of a well-
developed evidence base to identify best practices in the transfer of 
information from an HHA to another health care provider. Establishing a 
specific list of information that must be shared from an HHA to another 
health care provider creates a risk of simultaneously overburdening 
HHAs with elements that are not applicable and leaving out elements 
that are critical to assuring a safe and effective care transition in 
any given situation. The impracticality and potential ineffectiveness 
of such a list of mandatory discharge or transfer summary elements 
developed in the absence of public consensus and evidence-based 
practices would not improve patient care and safety, nor would it 
assure the efficient use of HHA resources. Therefore, we are not 
finalizing a list of requirements related to the content of the 
discharge summary. Rather, we are finalizing a requirement that HHAs 
must send all necessary medical information pertaining to the patient's 
current course of illness and treatment, post-discharge goals of care, 
and treatment preferences, to the receiving facility or health care 
practitioner to ensure the safe and effective transition of care. This 
broad, flexible requirement allows HHAs to tailor the exchange of 
information to the exact circumstances and needs of the care transition 
in order to support the patient's post-discharge goals.
    Sending the discharge summary to the follow-up care practitioner or 
facility was set forth in the HHA CoPs final rule, and we did not 
propose to modify that requirement. It is just as important for the 
receiving health care practitioner to be sent the discharge information 
as it is for the HHA to receive such information from the patient's 
previous care provider. For continuity of care and a smooth transition 
from the HHA, we believe the discharge summary will provide invaluable 
information to the receiving practitioner/facility to continue to meet 
the patient's care needs.
    We continue to believe that there are instances in which the 
receiving health care practitioner or facility would request additional 
information beyond that which the HHA provided in the discharge or 
transfer summary, such as the patient's actual plan of care. However, 
we agree with commenters that this information is not automatically 
necessary for each and every HHA patient discharge or transfer. 
Therefore, we have modified this requirement, as finalized at Sec.  
484.58(b)(2), to require HHAs to comply with requests for additional 
essential clinical information as may be necessary for treatment of the 
patient that are made by the receiving facility or health care 
practitioner. We believe that this change will assure that receiving 
facilities and practitioners have access to this information as needed, 
while not overburdening HHAs to preemptively provide such a potentially 
large volume of information that may not be helpful to receiving 
practitioners and facilities.
    Comment: One commenter stated that not all of the information in 
the plan of care and latest physician orders may be relevant at the 
time of discharge. CMS should allow the agency to determine which parts 
of the plan of care and physician orders are appropriate to be included 
in the discharge summary.
    Response: We appreciate the commenters' suggestions to allow the 
HHA to determine, which parts of the plan of care and physician orders 
are appropriate to include in the discharge summary. As noted above, we 
have revised the requirement at Sec.  484.58(b) to include only that 
medical information pertaining to the patient's current course of 
illness and treatment, post-discharge goals of care, and treatment 
preferences that is necessary to ensure the safe and effective 
transition of care, as identified by the HHA. We have replaced the 
proposed requirement that an HHA must send a copy of the plan of care 
with a requirement at Sec.  484.58(b)(2) that an HHA must comply with 
requests from receiving providers for additional essential clinical 
information as may be necessary for the treatment of the patient, which 
may include providing the receiving practitioner or facility with a 
copy of the plan of care. We believe that this revised approach 
balances the need for information exchange with the need for succinct, 
targeted communication among providers.
    Comment: Many commenters acknowledged that the requirements are 
intended to provide safe and efficient follow-up care planning. 
However, commenters believe that the information required in the 
proposed rule would involve volumes of documents, many of which would 
be duplicative of information provided in an EHR. One commenter 
acknowledged that the required elements for the discharge or transfer 
summary are aligned with the Common Clinical Data Set specified in the 
2015 Edition of the health IT certification criteria. The commenter 
stated that the most direct method to comply with the proposed 
discharge summary requirements is for agencies to utilize an 
interoperable EHR that could meet the Common Clinical Data Set 
specification that is supported by the Consolidated Clinical Document 
Architecture (C-CDA) and the 2015 Edition certification criteria for 
Sec.  170.315(b)(1) (Transitions of Care) and Sec.  170.315(b)(9) (Care 
Plan). Another commenter added that EHR vendors may be able to assist 
in the provision of this information because the commenter believes 
that the vendors can help streamline and standardize the exchange 
process for every discharge and transition. However, another commenter 
stated that current home care electronic medical record systems do not 
support the creation of a transfer summary and will require time to 
accomplish. In addition, the commenter stated that several of the data 
elements may not apply to every patient situation. The commenter added 
that simply stating 'not applicable' could be construed in a medical 
record as incomplete, unavailable, or unknown and that only the known, 
applicable data be included in the transfer summary, and that CMS 
should allow for a grace period to come into compliance with these new 
requirements.
    Response: We appreciate the comments regarding the discharge 
summary and the EHR. We understand that HHAs may face significant 
challenges in electronically exchanging the list of items originally 
set forth at proposed Sec.  484.58(b). In light of these challenges and 
for the reasons set forth above, we are not finalizing a list of items 
to be included in every discharge or transfer summary. We do believe 
that, over time, HHAs and all providers should continue to work toward 
fully implementing an EHR that is capable of collecting, sending, and 
receiving patient data to improve care transitions. We would expect 
acute care providers that collect data electronically to provide this 
information in an electronic format to HHAs that have the capacity to 
receive such electronic information and incorporate it into their EHRs. 
We also believe the HHA vendors can help streamline and standardize the 
exchange process for every discharge and transition.
    Comment: One commenter explained that transfers between HHAs are 
often initiated by the patient and patient transfers are unknown to the 
agency until the agency receives a call from the patient's new 
provider. The commenter

[[Page 51869]]

further noted that patients rarely consult with their current agency on 
the quality of a competitor. The commenter questioned how HHAs will be 
held accountable for compliance in instances when the HHA is unaware of 
a patient's transfer or pending transfer. The commenter recommended 
that language regarding transfers to a different HHA be changed to 
refer to only planned transfers in which the current HHA is involved.
    Response: We expect all HHAs to meet the requirements of this final 
rule. In accordance with the existing clinical records requirements at 
Sec.  484.110(a)(6), HHAs must send a completed transfer summary within 
2 business days of a planned transfer, if the patient's care will be 
immediately continued in a health care facility. If the transfer was 
unplanned, the HHA must send a completed transfer summary within 2 
business days of becoming aware of the unplanned transfer, only if the 
patient is still receiving care in a health care facility at the time 
when the HHA becomes aware of the transfer. There are additional 
requirements related to sending information following patient 
discharge, also located at Sec.  484.110(a)(6), that do not directly 
pertain to patient transfers.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing Sec.  484.58(b) with the following 
modifications:
     Revising Sec.  484.58(b)(1) to require that, instead of a 
specified list, the HHA must send necessary medical information 
pertaining to the patient's current course of illness and treatment, 
post-discharge goals of care, and treatment preferences to the 
receiving facility or health care practitioner to ensure the safe and 
effective transition of care.
     Revising Sec.  484.58(b)(2) to require the HHA to comply 
with requests for additional necessary clinical information made by the 
receiving facility or health care practitioner, which may include items 
such as a copy of the patient's current plan of care or latest 
physicians' orders.
Miscellaneous Comments (Proposed Sec.  484.58)
    Comment: We received one comment requesting that occupational 
therapists be listed as part of the discharge planning team needed to 
perform discharge assessment and planning. Another commenter suggested 
that CMS consider adding the role of the ``Discharge Intensivist.'' The 
commenter stated that the role can be an assistive role handled through 
a ``Discharge Health Coach (DHC)'' to effectuate a discharge plan. The 
role of a DHC would be an assistive role that is trained as a discharge 
coach. The commenter stated that this kind of collaborative 
communication doesn't currently exist in a home health agency, and 
needs to be created for the purpose of meeting the goal of effective 
discharge planning and execution.
    Response: We appreciate the comment on various professionals who 
may be involved in the discharge planning process. HHAs are permitted 
to involve any and all professionals, as appropriate to each patient's 
discharge plan. While we have removed the specific discharge planning 
requirements of proposed Sec.  484.58(a), HHAs will continue to engage 
in discharge planning as part of overall care planning set forth in 
Sec.  484.60. We encourage HHAs to utilize the expertise of all 
professionals involved in a patient's care, as well as any specialty 
services that may benefit HHAs and their patients.
    Comment: One commenter stated that we should include transitions to 
acute care, along with transitions to PAC facilities in setting out 
requirements for HHA discharge planning. The commenter added that the 
proposed regulations provide requirements for HHAs when discharging 
individuals to other PAC providers and believe that individuals would 
benefit from similar planning and information sharing when HHAs must 
send the individual back to acute care. The commenter recommended that 
documentation, including the individual's health history with previous 
functional status, current functional status, goals and preferences, be 
provided to the hospital in order to expedite care and discharge 
planning in the hospital setting.
    Response: We agree with the commenter's suggestion that HHAs can be 
integral in transitioning the individual back to acute care and that 
discharge summary documentation should be provided to expedite care and 
subsequent additional discharge planning in the hospital setting. The 
requirement at Sec.  484.58(b), ``Discharge or transfer summary 
content'', requires the HHA to send necessary medical information to 
the receiving facility or health care practitioner. This applies to 
patients discharged to an acute care setting.
    Comment: One commenter stated that HHAs should not be allowed to 
discharge patients who have an ongoing need unless they are discharging 
to a Medicaid consumer direction program. The commenter states that it 
is too easy for HHAs to discharge people who are difficult, or even 
those with difficult family members or those that require visits at 
inconvenient hours.
    Response: We appreciate the commenter's views and concerns. As 
finalized in the HHA CoP final rule, HHAs may only discharge patients 
for certain specific reasons. We believe that the requirements set 
forth at Sec.  484.50(d) appropriately regulate HHA discharge and 
transfer policies to prevent inappropriate discharges. Specifically, 
Sec.  484.50(d)(5)) requires that if the patient's (or other persons in 
the patient's home) behavior is disruptive, abusive, or uncooperative 
to the extent that delivery of care to the patient or the ability of 
the HHA to operate effectively is seriously impaired, the HHA must take 
numerous steps to resolve the problem and provide advance notice that a 
discharge is being considered. The HHA must advise the patient, 
representative (if any), the physician(s) issuing orders for the home 
health plan of care, and the patient's primary care practitioner or 
other health care professional (if any), who will be responsible for 
providing care and services to the patient after discharge from the 
HHA, that a discharge for cause is being considered. The HHA must also 
make efforts to resolve the problem(s) presented by the patient's 
behavior, the behavior of other persons in the patient's home, or 
situation. Furthermore, the HHA must provide the patient and 
representative (if any), with contact information for other agencies or 
providers who may be able to provide care. Finally, the HHA must 
document the problem(s) and efforts made to resolve the problem(s), and 
enter this documentation into its clinical records.
    Comment: A commenter stated that if a patient went from an HHA to a 
SNF there should be an independent review to see if the HHA did 
everything possible to prevent this outcome, including interviewing the 
patient. If the HHA was found to have caused the SNF admission directly 
or by omission, the HHA should have to pay for re-institutionalization.
    Response: At this time we do not require HHAs to track the patients 
at discharge. In addition, we do not have the ability to bill the HHA 
for re-institutionalization of the patient. This comment is beyond the 
scope of this final rule.
    Comment: One commenter requested that we require specific criteria 
for the discharge of people who are homeless. The commenter stated that 
HHAs should be prohibited from refusing to serve clients in homeless 
shelters or hotels serving as homes. The same commenter also suggested 
that there

[[Page 51870]]

should be someone to call who has the power to effect immediate 
intervention, if a patient is being discharged without instructions or 
without services being set up. They add that they are regularly called 
to try to assist people who have been discharged and they have no 
written instructions, or poorly written instructions, and they tried to 
protest or ask for additional information from the HHA without recourse 
or solution.
    Response: We appreciate the comments related to the discharge of 
patients who are homeless, and the lack of planning and discharge 
instructions for such patients. The HHA CoPs require HHAs to work with 
the patient and caregiver, including communication with the patient's 
physician(s), when updating the discharge plan. The HHA is also already 
required to educate and instruct the patient regarding his or her care 
responsibilities on an ongoing basis to prepare for ultimate discharge. 
Because education and training to facilitate discharge will have been 
provided during the entire course of HHA care, thus preparing patients 
and caregivers for discharge, this final rule does not include a 
requirement for discharge instructions. This final rule does not 
include a requirement for HHAs to establish follow-up services once a 
patient is discharged, as this is the role of the patient's primary 
care or other follow-up care practitioner. This final rule requires 
HHAs to send the patient discharge summary to the patient's follow-up 
health care provider to ensure that this essential information is 
communicated as the patient transitions care providers. Furthermore, 
this final rule requires HHAs to provide additional medically necessary 
information upon request from a receiving facility or practitioner. We 
believe that these requirements address these important concerns.
    Comment: One commenter suggested that CMS should require 
utilization of independent living centers instead of nursing homes for 
moderately functioning patients. The commenter stated that it is 
cheaper for the government and it gives patients an opportunity to 
improve on their physical and mental functions and hopefully be 
reintegrated into the community. Additionally, the commenter added that 
independent living centers should develop relationships with HHAs and 
give these patients services beyond room and board. These centers are 
considered homes to patients whose family members are unable to care 
for them.
    Response: We thank the commenter for their suggestion to require 
utilization of independent living centers instead of nursing homes for 
moderately functioning patients. However, these comments are beyond the 
scope of this rule and cannot be addressed.
    Final Decision: After consideration of the miscellaneous comments, 
we are not making any additional revisions to Sec.  484.58.

G. Critical Access Hospital Discharge Planning (Proposed Sec. Sec.  
485.635(a)(3)(viii) and 485.642)

    Sections 1820(e) and 1861(mm) of the Act require CAHs participating 
in Medicare and Medicaid to meet certain specified requirements. We 
have implemented these provisions in 42 CFR part 485, subpart F, 
``Conditions of Participation: Critical Access Hospitals (CAHs)''.
    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. 
Minimally, what was required under the former EACH/RPCH program was 
adopted for what is now the 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. Also, the CoPs at Sec.  485.635 
require a CAH to develop and keep current a nursing care plan for each 
patient receiving inpatient services.
    Given the IMPACT Act mandate, we proposed CAH discharge planning 
requirements. In the Discharge Planning proposed rule, we solicited 
comments on the timeline for implementation of the proposed CAH 
discharge planning requirements (80 FR 68139). We discuss the comments 
we received and our responses in section II.B of this final rule. We 
proposed to develop requirements in the form of five standards at Sec.  
485.642 and one additional standard at Sec.  485.635. 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 proposed to require that the CAH provide specific discharge 
instructions, as appropriate, for all patients.
    We proposed that each CAH's discharge planning process ensure that 
the discharge needs of each patient were identified and resulted in the 
development of an appropriate discharge plan for each patient.
    Comment: Many commenters agreed with including CAHs in the 
discharge planning requirements. The commenters stated that requiring 
CAHs to have a discharge planning CoP would assist in providing a 
systematic approach to effective and quality patient care. A commenter 
stated that the inclusion of patient considerations is important and 
they appreciate CMS's inclusion of statements about the importance of 
geography. One commenter stated that they support the requirement that 
the discharge planning policies and procedures be developed with input 
from the CAH's professional health care staff, nursing leadership as 
well as other relevant departments and be reviewed and approved by the 
governing body. The commenter further stated that this is the current 
process in many CAHs. However, one commenter stated that the current 
incentive programs to discourage readmissions already address many of 
the factors included in our proposed discharge planning requirement, 
such as the need for non-health care factors, and, therefore, this 
requirement is not necessary.
    Response: We appreciate the commenters' support for the CAH 
discharge planning requirements and we appreciate being made aware that 
many CAHs have developed policies and procedures for discharge 
planning. We are finalizing a revised version of the proposed CAH 
discharge planning requirements that focuses on patient outcomes and 
provides implementation flexibilities.
    Comment: Several comments stated that the CAH discharge planning 
requirements should be identical to the hospital discharge planning 
requirements.
    Response: The CAH discharge planning requirements are intentionally 
very similar to those of the hospital discharge planning requirements. 
However, there are some necessary differences as a result of some of 
the challenges that are unique to CAHs, including their rural location, 
small size, and limited resources.
    Comment: One commenter suggested that the requirements under Sec.  
482.43(f)(1) (regarding transfer to post-acute care services) apply to 
CAHs.
    Response: Section 4321 of the BBA amended the discharge planning 
requirements to require that the discharge planning evaluation indicate 
the availability of home health services provided by individuals or 
entities that participate in the Medicare program. Section 4321(a) of 
the BBA requires that hospitals, in their discharge planning 
evaluation, provide a listing regarding the ``availability of home 
health

[[Page 51871]]

services.'' This has been implemented in the hospital CoPs under Sec.  
482.43(c)(8). Section 926 of the MMA further amended 1861(ee) of the 
Act to include information regarding SNFs that participate in the 
Medicare program; the IMPACT Act added section 1899B of the Act further 
requires that CAHs provide patients with LTCH, IRF, HHA, and SNF data 
on quality measures and data on resource use measures. Section 4321 of 
the BBA did not apply to CAHs, given their rural location and the 
limited number of PAC providers in their geographic regions. We believe 
that extending this requirement to CAHs by regulation places an 
unnecessary burden on them. While CAHs are not required to include in 
the discharge plan a list of HHAs, SNFs, IRFs, or LTCHs, they are 
required to, like hospitals, assist patients, their families, or their 
caregivers or support persons in selecting a PAC provider. CAHs must do 
so by using and sharing data that includes but is not limited to HHA, 
SNF, IRF, or LTCH data on quality measures and resource use measures. 
Although CAHs are not required to include in the discharge plan a list 
of HHAs, SNFs, IRFs, or LTCHs, there is nothing prohibiting them from 
doing so.
Proposed Sec.  485.642
    We received no substantive comments on the introductory language of 
this provision. We are finalizing it with only minor stylistic 
amendments that do not affect the substance of the rule. As revised, 
the CAH must have an effective discharge planning process that focuses 
on the patient's goals and preferences and includes the patient and his 
or her caregivers/support person(s) as active partners in the discharge 
planning for post-discharge care. The discharge planning process and 
the discharge plan must be consistent with the patient's goals for care 
and his or her treatment preferences, ensure an effective transition of 
the patient from CAH to post-discharge care, and reduce the factors 
leading to preventable CAH readmissions.
1. Design (Proposed Sec.  485.642(a))
    We proposed at Sec.  485.642(a) to establish a new standard, 
``Design,'' to require a CAH to have policies and procedures for 
discharge planning that have been developed with input from the CAH's 
professional health care staff and nursing leadership, as well as other 
relevant departments. The policies and procedures would be approved by 
the governing body or responsible individual and be specified in 
writing. We did not receive any comments on this standard. However, 
upon further review, we believe that this requirement may be too 
process oriented and too prescriptive as written to finalize and that a 
further revision to this requirement for CAHs is warranted. We 
therefore, are not finalizing this requirement as proposed and we refer 
readers to section II.C.3 of this final rule for a detailed discussion 
of this decision.
2. Applicability (Proposed Sec.  485.642(b))
    We proposed 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 expect to be discharged or transferred to 
a hospital within 96 hours after admission to the CAH. We proposed 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 
health care staff and approved by the governing body or responsible 
individual.
    Comment: A number of commenters agreed with the proposal to broaden 
the categories of patients who would be evaluated for post-discharge 
needs. Several stated that they believed the inclusion of these 
categories of patients was necessary for effective transition from 
acute settings to post-acute settings. However, the majority of 
commenters expressed concern over the undue burden that they believe 
would result from this proposed change. Many stated that they believe 
that the current evaluation requirement is effective for screening and 
targeting high-risk patients who have true discharge needs. A number of 
commenter stated that they already routinely screen certain categories 
of outpatients, such as observation patients, and that automatically 
requiring discharge plans for patients in these categories would shift 
resources away from those patients most in need of discharge plan.
    Response: As with hospitals, we agree with commenters that the 
requirement needs to be scaled back in its scope and applicability to a 
more flexible requirement. We therefore, are not finalizing the 
requirements at proposed Sec.  485.642(b). Instead, we are finalizing 
requirements at Sec.  485.642(a) introductory text and (a)(2), 
respectively, that would require that a CAH's discharge planning 
process must identify, at an early stage of hospitalization, those 
patients who are likely to suffer adverse health consequences upon 
discharge in the absence of adequate discharge planning and must 
provide a discharge planning evaluation for those patients so 
identified, as well as for other patients upon the request of the 
patient, patient's representative, or patient's physician. In addition, 
at Sec.  485.642(a)(2), a discharge planning evaluation must include an 
evaluation of a patient's likely need for appropriate post-hospital 
services, including, but not limited to, hospice care services, post-
hospital extended care services, and home health services, and must 
also determine the availability of those services.
    Final Decision: Similar to hospitals, after consideration of the 
comments we received on the proposed rule, we are revising proposed 
Sec.  485.642(b), and finalizing as Sec.  485.642(a) introductory text 
and (a)(2), to require that the CAH's discharge planning process 
identify, at an early stage of hospitalization, those patients who are 
likely to suffer adverse health consequences upon discharge in the 
absence of adequate discharge planning, and must provide a discharge 
planning evaluation for those patients so identified, as well as for 
other patients upon the request of the patient, patient's 
representative, or patient's physician. A discharge planning evaluation 
must include an evaluation of a patient's likely need for appropriate 
post-hospital services, including, but not limited to, hospice care 
services, post-CAH extended care services, and home health services; 
such evaluation must also determine the availability of those services.
3. Discharge Planning Process (Proposed Sec.  485.642(c))
    We proposed 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 proposed 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 proposed at Sec.  485.642(c)(2) to require that the discharge 
planning process begin within

[[Page 51872]]

24 hours after admission or registration for each applicable patient 
identified under the proposed requirement at Sec.  485.642(b), and that 
the process be 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-related 
needs of the patient 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 noted 
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 proposed at Sec.  485.642(c)(3) that the CAH's discharge 
planning process 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 proposed 
at Sec.  485.642(c)(4) that the practitioner responsible for the care 
of the patient be required to be involved in the ongoing process of 
establishing the discharge plan.
    We proposed 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 proposed to require that 
CAHs must consider the availability of and access to non-health care 
services for patients, which could include home and physical 
environment modifications, transportation services, meal services, or 
household services, including housing for homeless patients. In 
addition, we encouraged 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 proposed 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 proposed 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 proposed 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 would be taken into account throughout the entire discharge 
planning process.
    We proposed at Sec.  485.642(c)(8) to require that CAHs assist 
patients, their families, or caregivers in selecting a PAC using IMPACT 
Act quality measures. This provision is part of our IMPACT Act 
requirements and is discussed later in this preamble.
    We proposed 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 would ensure that 
appropriate arrangements for post-CAH care were 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 proposed to require that 
the evaluation be included in the medical record. The results of the 
evaluation would 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 proposed 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 would have to 
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 were responsive to 
patient discharge needs.
    Comment: Several commenters stated that the rural location and 
small size of CAHs pose difficulties for them in ensuring that they 
have the appropriate staff available to implement the discharge 
planning requirements. As a result, the commenters expressed that it 
would present significant burden to CAHs if all proposed patients were 
required to have discharge planning within 24 hours of admission or 
registration. Commenters suggested that CAHs be permitted to use 
telehealth options to fulfill some of the requirements due to the 
issues they face related to staffing shortages.
    Response: The requirements do not prohibit the use of telehealth 
services to meet the discharge planning requirements so long as all of 
the discharge and telehealth requirements are met. It is not uncommon 
for CAHs to use telehealth services in the provision of patient care 
services given their rural location and their resultant staffing 
difficulties. In addition, we are finalizing our requirement at Sec.  
485.642(a) to state that any discharge planning evaluation or discharge 
plan required under this paragraph must be developed by, or under the 
supervision of, a registered nurse, social worker, or other 
appropriately qualified personnel. As such, CAHs are not limited to 
using social workers or case managers to meet these requirements. The 
CAH has the flexibility to determine and identify other personnel 
qualified to coordinate the discharge planning evaluation and 
development of the discharge plan. We expect that the CAH will identify 
personnel qualified to conduct this activity as part of its discharge 
planning process.
    Comment: One commenter stated that many rural Americans live in 
areas with limited health care resources, restricting their available 
options for care, including post-acute care options. As such, the 
commenter suggested that we allow rural hospitals to consider the

[[Page 51873]]

impact of incomplete quality reporting data for PAC providers in the 
local community or where limited resources are available to collect the 
data, especially where geographic considerations are especially 
important to the patient and caregivers.
    Response: We appreciate the constraints under which rural hospitals 
and CAHs must operate. Since the goal is to provide quality care for 
patients, we expect the providers to consider all information that is 
available and pertinent to a given location. The regulation will 
require rural providers to assist patients and their families, or their 
caregivers/support person in selecting a PAC by using and sharing data. 
The data that are provided should be pertinent to the patient's goals 
of care and treatment preferences. We expect that any available data 
will be shared with the patient and various support individuals, and 
that the provider will explain the issues or constraints with the data 
and advise the patient on seeking PACs outside of the local community. 
We also expect that providers in rural and frontier areas will extend 
their list of PAC providers to areas outside of the local community if 
necessary.
    Comment: One commenter stated that the requirement to utilize data 
on quality measures and data on resource use measures could be utilized 
to discourage the use of CAH swing beds in rural communities. Since the 
CAH swing bed program does not have to report data on its performance, 
referring facilities will list CAH Swing Bed on their referral list 
delivered to patients, but would have no data to include on the list. 
The commenter suggested that we require referring facilities to note on 
their discharge provider list that CAH swing beds are not required to 
report data similar to freestanding SNFs.
    Response: The CAH's responsibility is to advise and assist patients 
with their choices based on quality data and the patient's goals of 
care and treatment preferences. As such, we do not believe that any 
provider will be disadvantaged with this requirement.
    Final Decision: After consideration of the comments received on the 
proposed rule, both those discussed above and the comments discussed in 
conjunction with the parallel hospital provisions, we are finalizing 
and redesignating Sec.  485.642(c) with the following modifications:
     Revising and redesignating Sec.  485.642(c)(2) under Sec.  
485.642(a) to eliminate the 24-hour time frame requirements and to 
state that the CAH must identify at an early stage of hospitalization 
all patients who are likely to suffer adverse health consequences upon 
discharge if there is no adequate discharge planning.
     Revising and redesignating Sec.  485.642(c)(6) under Sec.  
485.642(a) to state that the patient and caregiver/support person(s), 
as applicable, must be involved in the development of the discharge 
plan, and informed of the final plan to prepare them for post-CAH care.
4. Discharge to Home (Proposed Sec.  485.642(d)(1) Through (3))
    We proposed 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 was referred 
to a PAC provider or supplier, the discharge instructions would be 
provided to the PAC provider/supplier.
    At Sec.  485.642(d)(2) we proposed that instructions on post-
discharge care include, but not be limited to, instruction on post-
discharge care, including instruction on durable medical equipment, if 
applicable, 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 proposed to require that the instructions include:
     Written information on warning signs and symptoms that may 
indicate the need to seek immediate medical attention.
     Prescriptions for medications that would be 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).
     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.
    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. Therefore, we 
proposed 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 reminded CAHs to provide this information in a manner that 
complied 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 recommended that CAHs consider the use of 
``teach-back'' techniques during discharge planning and upon providing 
discharge instructions to the patient.
    We proposed 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 instructions and medication regimens and improve patient 
safety and satisfaction. We proposed 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 noted the importance 
of ensuring that CAHs follow-up, post-discharge, with their most 
vulnerable patients, including those with behavioral health conditions.
    Final Decision: After consideration of the comments received on the 
proposed rule (as discussed under the hospital section), we are not 
finalizing Sec.  482.43(d). We are redesignating the proposed 
requirement in Sec.  485.642(d)(3) as Sec.  485.642(b) and we are 
eliminating the specific timeframe requirements. Section 485.642(b) 
provides that the CAH must discharge the patient, and also transfer or 
refer the patient where applicable, along with all necessary medical 
information pertaining to the patient's current course of illness and 
treatment, post-discharge goals of care, and treatment preferences, at 
the time of discharge, to the appropriate post-acute care service 
providers and suppliers, facilities, agencies, and other outpatient 
service providers and practitioners responsible for the patient's 
follow-up or ancillary care.

[[Page 51874]]

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 proposed 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 would have to include:
     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 directives, 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, and documentation as 
applicable, including a copy of the patient's discharge instructions, 
the discharge summary, and such information and documentation 
pertaining to current diagnoses, course of illness/treatment, 
laboratory results, procedures, functional status, and the patient's 
goals of care and treatment preferences, to ensure a safe and effective 
transition of care that supports the post-discharge goals for the 
patient.
    Final Decision: After consideration of the comments we received on 
the proposed rule, as discussed in the hospital section at section 
II.C.7 of this final rule, we are finalizing Sec.  485.642(e) with 
modifications. We are revising and redesignating Sec.  485.642 as 
follows:
     Removing proposed Sec.  485.642(a) and (b), and replacing 
these standards with revisions and redesignating as Sec.  485.642(a) 
titled ``Discharge planning process.'' The final standard at Sec.  
485.642(a) incorporates and combines provisions of the current hospital 
discharge planning requirements (that are statutorily required for 
hospitals) with revised provisions from the proposed requirements at 
Sec.  485.642(c).
     Removing proposed Sec.  485.642(c), (d), and (e) and 
replacing these standards with revisions and redesignating as Sec.  
485.642(b) titled ``Discharge and transfer of the patient and provision 
and transmission of the patient's necessary medical information.'' The 
final standard at Sec.  485.642(b) incorporates and combines revised 
provisions from the proposed requirements at Sec.  485.642(c), (d), and 
(e).
     Revising Sec.  485.642(b) to state that the CAH must 
provide and send the patient's necessary medical information to the 
receiving post-acute care services provider, if applicable, along with 
all necessary medical information .

III. Provisions of the Final Regulations

    In this final rule, we are adopting Sec.  482.13(d)(2) from the 
Hospital Innovation proposed rule with only two minor clarifying 
revisions. We are moving the phrase, ``including current medical 
records,'' to the beginning of the paragraph and by adding the word, 
``and,'' before the phrase, ``within a reasonable timeframe,'' so that 
this part of the provision now states that the patient has the right to 
access their medical records, including current medical records, upon 
an oral or written request, in the form and format requested by the 
individual, if it is readily producible in such form and format 
(including in an electronic form or format when such medical records 
are maintained electronically); or, if not, in a readable hard copy 
form or such other form and format as agreed to by the facility and the 
individual, and within a reasonable time frame.
    Additionally, we are adopting some of the provisions of the 
Discharge Planning proposed rule with the following extensive revisions 
and reorganizations of the final requirements as discussed above:
     Revising Sec. Sec.  482.43 and 485.642, respectively, to 
now require that the hospital (or CAH) must have an effective discharge 
planning process that focuses on the patient's goals and preferences 
and includes the patient and his or her caregivers/support person(s) as 
active partners in the discharge planning for post-discharge care. The 
discharge planning process and the discharge plan must be consistent 
with the patient's goals for care and his or her treatment preferences, 
ensure an effective transition of the patient from hospital (or CAH) to 
post-discharge care, and reduce the factors leading to preventable 
hospital (or CAH) readmissions.
     Removing Sec.  482.43(a), (b), and (c), respectively and 
Sec.  485.642(a), (b), and (c), and replacing these standards with 
revised and redesignated standards at Sec. Sec.  482.43(a) and 
485.642(a), respectively, entitled ``Discharge planning process'' for 
each section. The final standards at Sec. Sec.  482.43(a) and 
485.642(a) incorporate and combine provisions of the current hospital 
discharge planning requirements (that are statutorily required for 
hospitals) with revised provisions from the proposed requirements at 
Sec. Sec.  482.43(c) and 485.642(c), respectively.
     Removing Sec.  482.43(c), (d), and (e) for hospitals and 
Sec.  485.642(c), (d), and (e) for CAHs, and replacing these standards 
with revised and redesignated standards at Sec. Sec.  482.43(b) and 
485.642(b), respectively, entitled ``Discharge and transfer of the 
patient and provision and transmission of the patient's necessary 
medical information'' for each section. The final standards at 
Sec. Sec.  482.43(b) and 485.642(b) incorporate and combine revised 
provisions from the proposed requirements at Sec.  482.43(c), (d), and 
(e) for hospitals and Sec.  485.642(c), (d), and (e) for CAHs, 
respectively. Sections 482.43(b) and 485.642(b) state that the hospital 
(or CAH) must discharge the patient, and also transfer or refer the 
patient where applicable, along with all necessary medical information 
pertaining to the patient's current course of illness and treatment, 
post-discharge goals of care, and treatment preferences, at the time of 
discharge, to the appropriate post-acute care service providers and 
suppliers, facilities, agencies, and other outpatient service providers 
and practitioners responsible for the patient's follow-up or ancillary 
care.
     Redesignate and finalize proposed Sec.  482.43(f) at Sec.  
482.43(c) without modification.
    HHAs:
     Revising Sec.  484.58 to remove requirements related to 
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.
     Revising Sec.  484.58(a) to remove paragraphs (a)(1) 
through (5) and (7).

[[Page 51875]]

     Revising Sec.  484.58(a) to combine paragraph (a)(6) with 
the introductory statement for paragraph (a).
     Revising Sec.  484.58(b)(1) to require the HHA to send 
necessary medical information pertaining to the patient's current 
course of illness and treatment, post-discharge goals of care, and 
treatment preferences to the receiving facility or health care 
practitioner to ensure the safe and effective transition of care.
     Revising Sec.  484.58(b)(2) to require the HHA to comply 
with requests for additional information as may be necessary for 
treatment of the patient made by the receiving facility or health care 
practitioner, which may include items such as a copy of the patient's 
current plan of care or latest physicians' orders.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 30-day 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 solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs). Responses to comments received for this section 
can be found in section VI ``Regulatory Impact Analysis'' of this final 
rule.
    In the estimates that follow in this section of the preamble and in 
the Regulatory Impact Analysis (RIA), we estimate hourly costs. Using 
data from the Bureau of Labor Statistics (BLS) for May 2017, we have 
estimates of the national average hourly wages for all professions 
(these data can be seen at https://www.bls.gov/oes/2017/may/oes_nat.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.

A. ICRs Regarding Hospital Discharge Planning (Sec.  482.43)

    The requirements at Sec.  482.43(a)(8) (and all similar 
requirements set out at Sec.  485.642(a)(8) for CAHs and Sec.  
484.58(a) for HHAs), which correspond to the requirements of the IMPACT 
Act, are exempted from the application of the PRA pursuant to section 
1899B(m) of the Act. Therefore, we are not required to estimate the 
public reporting burden for information collection requirements for 
these specific elements of the final rule in accordance with chapter 
35, title 45 of the United States Code. Nor are we required to undergo 
the specific public notice requirements of the PRA. Therefore, the 
estimates we provide in the RIA section of this final 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 gave 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 final rule from PRA 
analysis. We further note that these 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.
    Whenever a patient is discharged or transferred to another 
facility, Sec.  482.43(b) requires hospitals to send necessary medical 
information to the receiving facility at the time of transfer. 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 (at Sec.  482.43(d) prior to 
finalization of this rule). Overall, we believe that almost all of the 
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 medication 
reconciliation is a near universal practice for inpatients. Thus, we 
believe that hospitals are already following most of these 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 rule.

B. ICRs Regarding Home Health Discharge Planning (Sec.  484.58)

    We are finalizing a new CoP at Sec.  484.58 that will require HHAs 
to develop and implement an effective discharge planning process.
    The requirements at Sec.  484.58(a) correspond to the requirements 
of the IMPACT Act, and are exempted from the application of the PRA 
pursuant to section 1899B(m) of the Act. Therefore, we are not required 
to estimate the public reporting burden for information collection 
requirements for that specific element of the final rule in accordance 
with chapter 35, title 45 of the United States Code. Nor are we 
required to undergo the specific public notice requirements of the PRA. 
Therefore, the estimates we provide in the RIA section of this final 
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.
    At Sec.  484.58(b), we are establishing another new standard, 
``Discharge or transfer summary content,'' to require that the HHA send 
necessary medical information pertaining to the patient's current 
course of illness and treatment, post-discharge goals of care, and 
treatment preferences, to the receiving facility or health care 
practitioner to ensure the safe and effective transition of care.
    We are also including a requirement at Sec.  484.58(b)(2) for HHAs 
to comply with requests for additional information as may be necessary 
for treatment of the patient made by the receiving facility or health 
care practitioner.
    To meet both the requirements to assist patients in selecting 
follow-up post-acute care providers and to develop a discharge or 
transfer summary for each patient, we estimate that it will take an HHA 
approximately 10 minutes (0.167 hours) per patient. Thus, for the 
12,600 HHAs, we estimate that complying with this requirement will 
require 3,006,000 burden hours (18 million patients x 0.167 hours) at 
an approximate cost of $213.4 million (3,006,000 burden hours x $71 
average hourly salary for a registered nurse (RN)).

[[Page 51876]]

    The cost of sending the discharge summary to the patient's next 
source of health care services, as required by Sec.  484.110(a)(6), was 
accounted for in the HHA CoP final rule (82 FR 4504) issued in January 
2017 and accompanying collection of information package (OMB Control 
Number 0938-1299). As this issue has already been addressed in separate 
rulemaking, and as we are not making any changes to the requirements 
for sending the discharge or transfer summary in this final rule, we 
are not modifying the existing burden estimates.
    We believe that providing additional information, upon request, to 
follow-up care providers is a standard practice for 90 percent of HHAs. 
Likewise, we believe that providing such documents upon request may 
represent a new burden for those 10 percent of HHAs who are not already 
engaging in such information sharing practices. Based on information 
provided by commenters, who indicated that follow-up care providers 
often do not want to receive the large volume of information found in a 
copy of a patient's plan of care, we do not believe that follow-up care 
providers will request additional documentation for most discharged or 
transferred patients. For purposes of this analysis only, we assume 
that follow-up care providers and facilities will only request 
additional documentation for 10 percent of an affected HHA's discharged 
or transferred patients.

(18 million patients x .1 affected HHAs = 1,800,000 patients in 
affected HHAs)
(1,800,000 patients in affected HHAs x .1 discharged or transferred 
patients who require additional documentation = 180,000 patients)
    Based on the above calculations, we estimate that up to 180,000 
requests for additional information will be made upon effected HHAs. We 
estimate that it will take 15 minutes to process each request and 
either print and fax, or otherwise send the additional requested 
documentation, for a total of 45,000 hours per year (180,000 requests x 
.25 hours per request) at a cost of $1,485,000 (45,000 hours x $33 
general office clerk hourly rate). Thus, we estimate compliance with 
this new CoP costs HHAs approximately $215 million annually ($213.4 
million to assist patients in selecting follow-up post-acute care 
providers and to develop a discharge or transfer summary for each 
patient + $1.5 million to process and send additional requested 
information).
    The information collection request related to the home health 
agency CoPs (OMB Control Number 0938-1299) will be revised and sent to 
OMB.

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 revisions will 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 finalizing new CAH 
discharge planning requirements.
    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 
CAH discharge planning requirements mirror those for hospitals, we 
believe that CAHs, like hospitals, are essentially already performing 
many of the 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).
    The new requirements at Sec.  485.642(a) require that the CAH's 
discharge planning process must identify, at an early stage of 
hospitalization, those patients who are likely to suffer adverse health 
consequences upon discharge in the absence of adequate discharge 
planning and must provide a discharge planning evaluation for those 
patients so identified as well as for other patients upon the request 
of the patient, patient's representative, or patient's physician.
    We also are requiring that each CAH's discharge planning process 
must:
     Be made on a timely basis to ensure that appropriate 
arrangements for post-CAH care will be made before discharge and to 
avoid unnecessary delays in discharge, a discharge planning evaluation 
must include an evaluation of a patient's likely need for appropriate 
post-CAH services, including, but not limited to, hospice care 
services, post-CAH extended care services, and home health services, 
and non-health care services and community based care providers, and 
must also determine the availability of the appropriate services as 
well as the patient's access to those services;
     That the discharge planning evaluation must be included in 
the patient's medical record for use in establishing an appropriate 
discharge plan and the results of the evaluation must be discussed with 
the patient (or the patient's representative);
     Upon the request of a patient's physician, the CAH must 
arrange for the development and initial implementation of a discharge 
plan for the patient;
     That any discharge planning evaluation or discharge plan 
required under this paragraph must be developed by, or under the 
supervision of, a registered nurse, social worker, or other 
appropriately qualified personnel;
     That the CAH'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; and
     That the CAH 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.
    The requirement at Sec.  485.642(a)(8) in particular corresponds to 
the requirements of the IMPACT Act, and is exempted from the 
application of the PRA pursuant to section 1899B(m) of the Act. 
Therefore, we are not required to estimate the public reporting burden 
for information collection requirements for that specific element of 
this final rule in accordance with chapter 35, title 45 of the United 
States Code. Nor are we required to undergo the specific public notice 
requirements of the PRA. Therefore, the estimates we provide in the RIA 
section of this final 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.
    Whenever a patient is discharged or transferred to another 
facility, Sec.  485.642(b) requires CAHs to send

[[Page 51877]]

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 Sec.  485.642(b)(1) 
through (6). 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 
necessary medical information included under Sec.  485.642(b)(1). Thus, 
we believe that CAHs are already following most of these requirements 
and therefore we will not be assessing any additional burden for this 
section beyond our estimate in the RIA of the one-time cost to CAHs to 
modify their policies and procedures in order to ensure that they are 
meeting the requirements of this rule.

V. Regulatory Impact Analysis

A. Statement of Need

    All major government regulations should undergo periodic review to 
ensure that they do not unduly burden regulated entities or the 
American people, and reflect current knowledge as to regulatory 
effects. In recent years, we have revised the CoPs and Cf Cs to reduce 
the regulatory burden on providers and suppliers. In doing so, we 
identified obsolete and burdensome regulations that could be eliminated 
or reformed to improve effectiveness or reduce unnecessary reporting 
requirements and other costs, with a particular focus on freeing up 
resources that health care providers, health plans, and states could 
use to improve or enhance patient health and safety. This final rule 
focuses on reforms to discharge procedures that will enhance patient 
health and safety by filling gaps, while providing appropriate 
flexibility.
    In line with HHS' goals to improve interoperability between 
patients and their health care providers, we are finalizing certain 
discharge planning requirements for hospitals (including LTCHs and 
IRFs), HHAs, and CAHs as well as finalizing the hospital patients' 
rights requirement regarding patient access to medical records. We are 
also finalizing the requirements of the IMPACT Act for hospitals, HHAs, 
and CAHs. We believe that these final requirements will empower 
patients to be active participants in the discharge planning process 
and will help them to make informed choices about their care, which 
will lead to more competition, lower costs, and improved quality of 
care. Furthermore, the IMPACT Act requirements will give 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 
who are well informed of their choices of high-quality PAC providers 
may reduce their chances of being re-hospitalized.
    We believe these final requirements will also encourage 
interoperability, which allows patients to have access and full control 
over their medical records and encourages the seamless exchange of 
patient information between health care settings. Ultimately, these 
final requirements will ensure that a patient's health care information 
follows them after discharge from a hospital or PAC provider to their 
receiving health care facility, whether that be their primary care 
physician or a SNF.
    Furthermore, discharge planning is an important component of 
successful transition from hospital 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), SNF or nursing home, LTCH, 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 (as appropriate) 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 by focusing 
requirements on cases where risks are highest and by allowing providers 
to focus resources on such cases.
    Executive Order 13563 on Improving Regulation and Regulatory Review 
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.'' This final rule applies that 
mandate to discharge planning.
    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. The importance 
of this retrospective review has been underscored by recent findings on 
health care delivery problems related to hospitalization, including 
discharge and readmissions, indicating 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.).
    The comments and our responses to the Collection of Information 
(COI) Requirements and the Regulatory Impact Analysis (RIA) sections 
are as follows.
    Comment: Many commenters stated that we underestimated the 
implementation cost for the proposed requirements for hospitals and, 
particularly, CAHs. They stated that many of the proposed requirements 
were burdensome and overly prescriptive and that we underestimated the 
cost of hiring new staff, training existing staff, and updating and 
changing EHRs.
    Response: We have significantly scaled back our proposed 
requirements and are finalizing a more limited set of discharge 
planning and other requirements as explained throughout the preceding 
preamble discussion. There are more than a dozen areas where this final 
rule limits and reduces costs along the lines suggested by

[[Page 51878]]

commenters. For example, commenters presented evidence that our 
proposed requirements would impose unreasonable burdens on HHAs in 
obtaining involvement of patients' physicians in discharge planning, 
and on hospitals in obtaining and using PDMP information. We greatly 
appreciate the detailed comments we received and the regulatory 
improvements that they recommended. In the responses that follow, we 
address primarily those comments focusing specifically on the 
collection of information requirements and regulatory impact analysis 
sections of this final rule, or involving particularly costly or cost-
saving issues. These are only a fraction of those dealing with costs or 
burdens that are already addressed in the preamble.
    Comment: Regarding the changes to the HHA requirements, one 
commenter pointed out that we did not estimate the cost of training 
clinicians to understand and effectively put into practice the new 
policies and procedures. The commenter also noted the need for CMS to 
calculate the cost for changes to an HHA's electronic health records to 
incorporate the revisions to the rule here.
    Response: We have not estimated training costs since we believe 
that training related to changes in policies and procedures or to 
improve implementation of existing policies and procedures is an 
ongoing process in HHAs. In this final rule we have focused on ways to 
make minor modifications to existing processes that can be implemented 
with minimal training. For the costs to an HHA's electronic health 
records, we have removed the list of specific information that must be 
included in the discharge or transfer summary. The current HHA CoPs at 
Sec.  484.110 already require HHAs to send a discharge or transfer 
summary to the receiving provider, so the software used by HHAs to 
complete this task already exists. As HHAs are already required to 
prepare and send a transfer or discharge summary, we do not believe 
that there are substantial additional costs, not already accounted for 
in section IV ``Collection of Information Requirements'' of this final 
rule that should be included in our analysis.
    Comment: One commenter requested that we calculate the costs for 
the time required for an HHA physical therapist to create exercise and 
activity recommendations for patients recovering from orthopedic or 
neurologic injuries at home.
    Response: We do not believe that such costs are related to the new 
requirements finalized here, so we have not included estimates in the 
COI or RIA sections.
    Comment: Several commenters disagreed with our estimates on the 
amount of time that it would take an HHA to develop a discharge plan 
per patient. One commenter stated that we have underestimated the time 
required of an RN or physical therapist to complete the HHA standards 
finalized here. The commenter believes that it would take 10 to 15 
minutes, not 5, for a nurse or therapist to assemble all of the 
information, review the medication list for accuracy, review the goals 
for completeness, and draft the recommendations for care following 
discharge.
    Response: We agree with the commenters and have made the relevant 
adjustments in section IV ``Collection of Information Requirements'' of 
this final rule to use an estimate of 10 minutes. We chose 10 minutes 
because we believe that there will be many relatively uncomplicated 
cases where 5 minutes would be sufficient, and relatively few where 15 
minutes would be necessary, especially since the final rule provisions 
streamline and reduce the burden compared to the more onerous 
provisions in the proposed rule that these commenters reviewed. We note 
that the proposed rule would have shown total information collection 
burden costs of over $550 million annually had this estimate been more 
realistic in the Discharge proposed rule.
    Comment: Numerous commenters argued that we should add additional 
occupational specialties to the hospital discharge planning team. Among 
the categories recommended were physical therapy, nutrition, mental 
health, dental, durable medical equipment, and others. These commenters 
argued that some patients would have specialized needs in such 
categories of subsequent care.
    Response: We disagree with the commenters and have added none of 
the recommended categories. This would have added immensely to the 
complexity and cost of the discharge planning process. It is the 
function of the discharge experts already used by each hospital 
(usually including an expert RN or social worker) to identify such 
needs, as pertinent to each patient, and tailor the discharge plan to 
that patient.

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), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and 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 an 
RIA that to the best of our ability presents the costs and benefits of 
the rulemaking. This final rule will create both one-time and annual 
costs for hospitals, CAHs and HHAs. The financial costs are summarized 
in Table 1.

[[Page 51879]]



          Table 1--Section-By-Section Economic Impact Estimates
------------------------------------------------------------------------
                                             Number of       Estimated
  Provider/supplier and description of       affected        costs ($
           proposed provisions               entities        millions)
------------------------------------------------------------------------
                                 Annual
------------------------------------------------------------------------
Hospitals (Sec.   482.43)...............           4,900           ( * )
HHAs: Discharge Planning Process(Sec.             12,600           213.4
 484.58)................................
HHAs: Requests for Information (Sec.              12,600             1.5
 484.58)................................
                                         -------------------------------
    Total...............................  ..............           214.9
------------------------------------------------------------------------
                                One-time
------------------------------------------------------------------------
Hospitals (Sec.   482.43)...............           4,900            17.7
CAHs (Sec.   485.642)...................           1,353             1.9
HHAs (Sec.   484.58)....................          12,600            10.8
Cost of reviewing final rule............          18,853            16.1
                                         -------------------------------
    Total...............................  ..............            46.5
------------------------------------------------------------------------
* Less than $1 million.

C. Anticipated Effects

1. Effects on Hospitals (Including LTCHs and IRFs), CAHs, and HHAs
    We have accounted for the regulatory impact of these changes 
through the analysis of costs contained in the ICR sections previously 
mentioned in this final rule. We believe these estimates encompass most 
additional burden on hospitals, CAHs, and HHAs, with the exception of 
the following one-time costs to review the revised requirements and 
adjust internal procedures to assure compliance, particularly in the 
area of providing quality information to patients for multiple 
providers of post-discharge services. Any burden associated with the 
changes to the CoPs not accounted for in the ICR section or in the RIA 
section was omitted because we believe it would constitute an 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 websites Hospital Compare, 
Nursing Home Compare and Home Health Compare, as well as other public 
and private websites and their own knowledge of local providers, and 
presumably many or most use this information as appropriate to counsel 
patients.
    Hospitals will need to review their current policies and procedures 
and update them so that they comply with the modified requirements, 
which will be a one-time burden on each hospital. We estimate that an 
administrator will spend 8 hours on this activity for a total of 8 
hours per hospital at a cost of $1,680 (8 hours x $210 for an 
administrator's hourly salary cost), together with an RN or equivalent 
for an additional 8 hours at a cost of $568 (8 hours x $71 for an RN 
salary cost). Lawyer and physician time will also be used. We assume 4 
hours of legal time at $136 an hour for a cost of $544 and 4 hours of 
physician time at $203 an hour for a cost of $812. For all hospitals to 
comply with this requirement, we estimate a total one-time cost of 
approximately $17.7 million (4,900 hospitals x $3,604 ($1,680 plus $568 
plus $544 plus $812 = $2,780)).
    We are establishing a new standard at Sec.  484.58(a), ``Discharge 
planning process,'' to require that the HHA's discharge planning 
process provide certain information to those patients who are 
discharged or transferred to another post-acute care provider in order 
to assist patients and families in selecting a provider that meets the 
patient's needs and goals. HHAs will need to review their current 
policies and procedures and update them so that they comply with the 
requirements in Sec.  484.58(a), which will be a one-time burden on the 
HHA. We estimate that this will require an administrator using the 
average hourly salary of a medical and health services manager as 
determined by the BLS, doubled to account for fringe benefits and 
overhead. We estimate that the administrator will spend 8 hours on this 
activity for a total of 8 hours per HHA at a cost of $856 (8 hours x 
$107 for an administrator's hourly salary). For all HHAs to comply with 
this requirement, we estimate a total one-time cost of approximately 
$10.8 million (12,600 HHAs x $856).
    The requirement at Sec.  485.642(a)(8), which is associated with 
the IMPACT Act, will require CAHs to review their current policies and 
procedures and update them so that they comply with the new 
requirements, which will be a one-time burden on the CAH. We estimate 
that the administrator will spend 8 hours on this activity for a total 
of 8 hours per CAH at a cost of $856 (8 hours x $107 for an 
administrator's hourly salary cost), together with an RN or equivalent 
for an additional 8 hours at a cost of $568 (8 hours x $71 for an RN 
salary cost). The total burden hours are 21,648 (16 hours x 1,353 
CAHs). For all CAHs to comply with this requirement, we estimate a 
total one-time cost of approximately $1.9 million (1,353 CAHs x ($856 
plus $568)).
    Our estimates of the effects of this regulation are subject to 
significant uncertainty. While HHS is confident that these changes 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, HHAs, and CAHs in these 
matters.

[[Page 51880]]

    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. The Discharge Planning proposed rule was 
estimated to have total first year costs of $454 million (80 FR 68148), 
and annual costs thereafter of $396 million. As previously discussed, 
both these numbers would have been about $100 million higher if the 
time needed for HHA discharge functions had been estimated more 
realistically. This final rule, in contrast, has estimated total first 
year costs of $262 million and annual costs thereafter of $215 million. 
This reduction of costs by more than half reflects some downward re-
estimates, but mainly our efforts to remove overly prescriptive and 
costly process requirements that had originally been proposed. It also 
reflects the many comments we received pointing out ways to improve the 
rule. These changes show both the benefits of the public comment 
process under the Administrative Procedure Act, and the focus of CMS in 
developing final rules in complying with the goals of the laws and 
Executive Orders previously discussed, especially Executive Orders 
12866, 13563 and 13771.
2. Effects on Small Entities
    The Regulatory Flexibility Act (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 will be affected by our rules are small entities as that 
term is used in the RFA. The great majority of hospitals and most other 
health care 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 
final rule will cost affected entities approximately $215 million a 
year. Virtually all of these costs will impact HHAs. Total annual 
revenues of HHAs are approximately $100 billion a year (see Anne B. 
Martin et al, ``National Health Care Spending In 2017,'' Health 
Affairs, January 2019) and there are about 12,600 HHAs. Hence, the 
average cost per HHA would be about $17,000, about one fifth of one 
percent of annual revenues. All HHAs are not ``average'' in size, and 
about 2,000 of them have fewer than 10 employees. But our annual cost 
estimates are directly proportional to number of patients, so costs to 
even the smallest HHAs would be well under one percent of annual 
revenues. 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 rule will not have a significant economic impact on a 
substantial number of small entities, and certify that a Final 
Regulatory Flexibility Analysis is not required. Regardless, this RIA 
and the remainder of the preamble together meet the RFA requirements 
for such an analysis. In particular, we call attention to the many 
places in the non-RIA sections of the preamble where public comments 
helped us to analyze particular options and reject those that would 
have unnecessarily placed far higher burdens on HHAs or other entities. 
Specifically, our rejection of options that would have required 
consultations with health care professionals of many kinds, rather than 
consultations only as necessary for a particular patient, avoided very 
substantial costs on small entities.
    Under the proposed rule costs to hospitals would have exceeded $100 
million annually. We note that quite apart from the gross amount of 
such compliance costs 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 any hospital 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. Under 
this final rule hospital and CAH costs have been essentially 
eliminated, and hence we anticipate no impact on 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 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 604 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 rule will 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 2019, that 
threshold is approximately $154 million. Although this rule does not 
technically require HHAs to incur the costs unless they participate in 
Medicare, as a practical matter few HHAs could remain in business 
without participating in Medicare and these costs exceed this threshold 
in early years before subsequent payment increases take increased costs 
into effect. Mandated spending for CAHs, in contrast, is largely 
reimbursed on a cost basis and would not count as an unfunded mandate 
even in early years. This RIA and the other preamble sections together 
meet the UMRA requirements for analysis of the costs to these 
providers.
    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, preempt state law, or otherwise have federalism 
implications. This final rule will not have a substantial direct effect 
on state or local governments, preempt state law, or otherwise have 
federalism implications.
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

[[Page 51881]]

suggests that there would be reductions in morbidity and mortality from 
improving services to these patients through improved discharge 
planning. We are, however, unable to quantify either the volume or 
dollar value of these 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 
and Medicaid 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 rule. 
Nonetheless, the number of patients potentially benefitting is 
significant.
    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 exist on the effectiveness of these requirements 
compared to the normal effects of good medical practice. The changes 
that will be implemented by this 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 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.\1\
---------------------------------------------------------------------------

    \1\ Kim J. Verhaegh et al, ``Transitional Care Interventions 
Prevent Hospital Readmissions for Adults with Chronic Illnesses,'' 
Health Affairs, 33, no. 9 (2014):1531 through 1539.
---------------------------------------------------------------------------

4. Regulatory Review Cost Estimate
    One of the costs of compliance with a final rule is the necessity 
for affected entities to review the rule in order to understand what it 
requires and what changes the entity will have to make to come into 
compliance. The particular staff involved in such a review will vary 
from provider to provider. We believe that a good approximation for a 
range of staff would be a person such as a medical and health service 
manager. Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $107 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/2017/may/oes_nat.htm. Assuming an average 
reading speed, we estimate that it will take approximately 4 hours for 
each of the staff involved to review this final rule and its relevant 
sections and that on average two persons on staff will engage in this 
review (more for hospitals and CAHs and fewer for HHAs). For each 
entity that reviews the rule, the estimated cost is therefore $856 (4 
hours each x 2 staff x $107 per hour each). Therefore, we estimate that 
the total cost of reviewing this rule, assuming two reviewers per 
affected entity, is $16.1 million ($856 x 18,853 affected entities).

D. Alternatives Considered

    As we previously stated in this final rule, some of these 
provisions are mandated under the IMPACT Act; therefore, no major 
alternatives were considered for those provisions. For the other 
provisions, we considered a wide range of alternatives, but determined 
that none of them would result in substantial benefits at a reasonable 
cost.
    For all provisions, we attempted to minimize unnecessarily 
prescriptive methods or procedures, and to avoid any unnecessarily 
costly and burdensome requirements. Of particular importance for this 
final rule, the public comments were exceptionally useful in 
identifying weak or unjustified provisions in the proposed rule as well 
as in identifying alternatives. These alternatives are discussed 
throughout the preamble. The three most costly alternatives that we 
considered and rejected were requiring specific post-discharge 
procedures for every patient, requiring that discharge plans be 
prepared and revised on specific hourly schedules for every patients, 
and requiring direct individual consultation with a wide range of 
health care professionals for every patient.
    For the alternative of specific post-discharge follow-up 
procedures, we concluded that the range of procedures was so great 
(including 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 we could devise no reasonable or practicable requirement that 
would sensibly apply to all or most patients. Of course, we encourage 
providers to use follow-up procedures they find cost-effective for 
particular categories of patients.
    The alternative of requiring specific hourly deadlines for 
beginning a discharge plan would have created immense costs due simply 
to the myriad circumstances of hospital patients, as described by many 
examples in the comments. Likewise, commenters identified no 
consequential benefits, and major costs, were we to impose discharge 
planning on ambulatory care not even involving an overnight hospital 
stay, and involving such low risk procedures as providing tooth 
fillings, cataract surgery, and carpal tunnel surgery.
    The third alternative arose from comments from a number of 
professional associations and individual professionals asking that we 
mandate use of their particular professions in discharge planning for 
every patient. These would also have been very costly to impose. As 
previously discussed, we found no reason to believe that routinely 
using these professionals in all discharge planning would have provided 
consequential benefits over and above benefits from selective 
consultation where indicated by patient-specific conditions.

E. Cost to the Federal Government

    When these requirements are finalized, CMS will update the 
interpretive guidance, update the survey process, and provide training. 
In order to make these three changes, we anticipate initial, one-time 
federal startup costs at 4 or 5 person-years, and hence total cost of 
approximately 1 million dollars including overhead costs and fringe 
benefits. CMS plans to rely on CMS program management resources to 
support these costs. The continuing annual costs (survey process-
recertifications, enforcement by states or accredited organizations, 
appeals, AO) will not change from current levels.

F. Accounting Statement

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), 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 10 years as 
an estimating horizon, and used low and high estimates that are 25 
percent lower or higher than our primary estimate. We note that the 
accounting statement for the proposed rule showed annual costs of about 
$420 million in 2015 dollars, and that the changes made in this final 
rule have cut that cost in half. This reduction is even larger in real 
terms because public comments showed us that the Discharge

[[Page 51882]]

proposed rule would have been about $100 million annually more costly 
than estimated.

                                      Table 2--Accounting Statement: Classification of Estimated Costs and Benefits
                                                                     [$ in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                               Units
                        Category                              Primary      Low estimate    High estimate -----------------------------------------------
                                                             estimate                                      Year dollars    Discount rate  Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits--Qualitative not quantitative or monetized.....    Potential Reductions in morbidity, mortality, and medical costs for hospital, HHA, and CAH
                                                                                                     patients.
                                                         -----------------------------------------------------------------------------------------------
Costs--Annualized Monetized Costs of Discharge Planning              220             170             280            2017              7%       2019-2028
 to Medical Care Providers..............................
                                                                     220             170             280            2017              3%       2019-2028
                                                         -----------------------------------------------------------------------------------------------
Transfers...............................................                                               None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of Executive Order 12866, this 
rule was reviewed by the Office of Management and Budget.

G. Regulatory Reform Analysis Under Executive Order 13771

    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017 and requires that the 
costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' This final rule 
imposes costs and therefore is considered to be a regulatory action 
under Executive Order 13771. We estimate that this rule will impose 
annualized costs of approximately $175 million discounted relative to 
2016 over a perpetual time horizon.

H. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as a major rule, as defined by 5 U.S.C. 804(2). As such, this rule has 
been transmitted to the Congress and the Comptroller General for 
review.

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, Privacy, 
Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
and Medicaid Services amends 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:  42 U.S.C. 1302, 1395hh, 1395rr, and 1395lll unless 
otherwise noted.


0
2. Section 482.13 is amended by revising paragraph (d)(2) to read as 
follows:


Sec.  482.13  Condition of participation: Patient's rights.

* * * * *
    (d) * * *
    (2) The patient has the right to access their medical records, 
including current medical records, upon an oral or written request, in 
the form and format requested by the individual, if it is readily 
producible in such form and format (including in an electronic form or 
format when such medical records are maintained electronically); or, if 
not, in a readable hard copy form or such other form and format as 
agreed to by the facility and the individual, and within a reasonable 
time frame. The hospital must not frustrate the legitimate efforts of 
individuals to gain access to their own medical records and must 
actively seek to meet these requests as quickly as its record keeping 
system permits.
* * * * *

0
3. Section 482.43 is revised to read as follows:


Sec.  482.43  Condition of participation: Discharge planning.

    The hospital must have an effective discharge planning process that 
focuses on the patient's goals and treatment preferences and includes 
the patient and his or her caregivers/support person(s) as active 
partners in the discharge planning for post-discharge care. The 
discharge planning process and the discharge plan must be consistent 
with the patient's goals for care and his or her treatment preferences, 
ensure an effective transition of the patient from hospital to post-
discharge care, and reduce the factors leading to preventable hospital 
readmissions.
    (a) Standard: Discharge planning process. The hospital's discharge 
planning process must identify, at an early stage of hospitalization, 
those patients who are likely to suffer adverse health consequences 
upon discharge in the absence of adequate discharge planning and must 
provide a discharge planning evaluation for those patients so 
identified as well as for other patients upon the request of the 
patient, patient's representative, or patient's physician.
    (1) Any discharge planning evaluation must be made on a timely 
basis to ensure that appropriate arrangements for post-hospital care 
will be made before discharge and to avoid unnecessary delays in 
discharge.
    (2) A discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-hospital services, 
including, but not limited to, hospice care services, post-hospital 
extended care services, home health services, and non-health care 
services and community based care providers, and must also include a 
determination of the availability of the appropriate services as well 
as of the patient's access to those services.

[[Page 51883]]

    (3) The discharge planning evaluation must be included in the 
patient's medical record for use in establishing an appropriate 
discharge plan and the results of the evaluation must be discussed with 
the patient (or the patient's representative).
    (4) Upon the request of a patient's physician, the hospital must 
arrange for the development and initial implementation of a discharge 
plan for the patient.
    (5) Any discharge planning evaluation or discharge plan required 
under this paragraph must be developed by, or under the supervision of, 
a registered nurse, social worker, or other appropriately qualified 
personnel.
    (6) 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.
    (7) 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.
    (8) The hospital must assist 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.
    (b) Standard: Discharge of the patient and provision and 
transmission of the patient's necessary medical information. The 
hospital must discharge the patient, and also transfer or refer the 
patient where applicable, along with all necessary medical information 
pertaining to the patient's current course of illness and treatment, 
post-discharge goals of care, and treatment preferences, at the time of 
discharge, to the appropriate post-acute care service providers and 
suppliers, facilities, agencies, and other outpatient service providers 
and practitioners responsible for the patient's follow-up or ancillary 
care.
    (c) Standard: Requirements related to 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) and (b) 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 
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
4. The authority citation for part 484 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395(hh) unless otherwise 
indicated.


0
5. Section 484.58 is added to read as follows:


Sec.  484.58  Condition of participation: Discharge planning.

    (a) Standard: Discharge planning. An HHA must develop and implement 
an effective discharge planning process. 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.
    (b) Standard: Discharge or transfer summary content. (1) The HHA 
must send all necessary medical information pertaining to the patient's 
current course of illness and treatment, post-discharge goals of care, 
and treatment preferences, to the receiving facility or health care 
practitioner to ensure the safe and effective transition of care.
    (2) The HHA must comply with requests for additional clinical 
information as may be necessary for treatment of the patient made by 
the receiving facility or health care practitioner.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
6. The authority citation for part 485 is revised to read as follows:

     Authority:  42 U.S.C. 1302 and 1395(hh).


0
7. 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) Policies and procedures that address the post-acute care 
needs of patients receiving CAH services.
* * * * *

0
8. Section 485.642 is added to read as follows:

[[Page 51884]]

Sec.  485.642  Condition of participation: Discharge planning.

    A Critical Access Hospital (CAH) must have an effective discharge 
planning process that focuses on the patient's goals and treatment 
preferences and includes the patient and his or her caregivers/support 
person(s) as active partners in the discharge planning for post-
discharge care. The discharge planning process and the discharge plan 
must be consistent with the patient's goals for care and his or her 
treatment preferences, ensure an effective transition of the patient 
from the CAH to post-discharge care, and reduce the factors leading to 
preventable CAH and hospital readmissions.
    (a) Standard: Discharge planning process. The CAH's discharge 
planning process must identify, at an early stage of hospitalization, 
those patients who are likely to suffer adverse health consequences 
upon discharge in the absence of adequate discharge planning and must 
provide a discharge planning evaluation for those patients so 
identified as well as for other patients upon the request of the 
patient, patient's representative, or patient's physician.
    (1) Any discharge planning evaluation must be made on a timely 
basis to ensure that appropriate arrangements for post-CAH care will be 
made before discharge and to avoid unnecessary delays in discharge.
    (2) A discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-CAH services, including, but 
not limited to, hospice care services, post-CAH extended care services, 
home health services, and non-health care services and community based 
care providers, and must also include a determination of the 
availability of the appropriate services as well as of the patient's 
access to those services.
    (3) The discharge planning evaluation must be included in the 
patient's medical record for use in establishing an appropriate 
discharge plan and the results of the evaluation must be discussed with 
the patient (or the patient's representative).
    (4) Upon the request of a patient's physician, the CAH must arrange 
for the development and initial implementation of a discharge plan for 
the patient.
    (5) Any discharge planning evaluation or discharge plan required 
under this paragraph must be developed by, or under the supervision of, 
a registered nurse, social worker, or other appropriately qualified 
personnel.
    (6) The CAH'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.
    (7) The CAH 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.
    (8) The CAH must assist 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 
CAH 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.
    (b) Standard: Discharge of the patient and provision and 
transmission of the patient's necessary medical information. The CAH 
must discharge the patient, and also transfer or refer the patient 
where applicable, along with all necessary medical information 
pertaining to the patient's current course of illness and treatment, 
post-discharge goals of care, and treatment preferences, at the time of 
discharge, to the appropriate post-acute care service providers and 
suppliers, facilities, agencies, and other outpatient service providers 
and practitioners responsible for the patient's follow-up or ancillary 
care.

    Dated: August 20, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 17, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-20732 Filed 9-25-19; 11:15 am]
BILLING CODE 4120-01-P