[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
[[Page 51836]]
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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
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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
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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