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, 51836-51884 [2019-20732]
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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
Table of Contents
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
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, LongTerm 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
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SUMMARY:
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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
§ 482.43(c)(8), Proposed § 484.58(a)(6),
and Proposed § 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 § 482.13(d)(2))
2. Conditions of Participation (CoP)—
Discharge Planning (Proposed § 482.43)
3. Design (Proposed § 482.43(a))
4. Applicability (Proposed § 482.43(b))
5. Discharge Planning Process (Proposed
§ 482.43(c))
6. Discharge to Home (Proposed
§ 482.43(d))
7. Transfer of Patients to Another Health
Care Facility (Proposed § 482.43(e))
8. Requirements for Post-Acute Care (PAC)
Services (Proposed § 482.43(f))
F. Home Health Agency Discharge
Planning (Proposed § 484.58)
1. Discharge Planning Process (Proposed
§ 484.58(a))
2. Discharge or Transfer Summary Content
(Proposed § 484.58(b))
G. Critical Access Hospital Discharge
Planning (Proposed § 485.642)
1. Design (Proposed § 485.642(a))
2. Applicability (Proposed § 485.642(b))
3. Discharge Planning Process (Proposed
§ 485.642(c))
4. Discharge to Home (Proposed
§ 485.642(d)(1) through (3))
5. Transfer of Patients to Another Health
Care Facility (Proposed § 485.642(e))
III. Provisions of the Final Regulations
IV. Collection of Information Requirements
A. ICRs Regarding Hospital Discharge
Planning (§ 482.43)
B. ICRs Regarding Home Health Discharge
Planning (§ 484.58)
C. ICRs Regarding Critical Access Hospital
Discharge Planning (§ 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
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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 rehospitalized.
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
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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-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-of-2014-DataStandardization-and-Cross-SettingMeasures.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
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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 longterm, high quality outcomes; (3) in
January 2015 we implemented a public
mail box for the submission of
comments located at
PACQualityInitiative@cms.hhs.gov. The
CMS public mailbox can be accessed on
our PAC quality initiatives website:
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/Submita-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 CMSapproved 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
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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 personcentered 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
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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 personcentered 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
§§ 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 §§ 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,
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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
§§ 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
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51839
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 § 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.think
culturalhealth.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, https://
www.hhs.gov/civil-rights and https://
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.
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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 personcentered 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
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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 § 482.43
for hospitals and § 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 § 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
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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 § 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 subregulatory 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.
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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 § 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.
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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
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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 realtime, 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=44af376318fa3e70-44af065c-0cc47adb5650601d6acb74373f82&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
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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-datainteroperability-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 publicprivate 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
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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
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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 machinereadable formats while reducing
restrictive burdens on healthcare
providers (84 FR 7610). Specifically, the
proposed rule would revise the CoPs by
requiring a hospital, psychiatric
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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
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51843
for sharing data. (ONC/American
Hospital Association (AHA), AHA
Annual Survey Information Technology
Supplement (https://
dashboard.healthit.gov/evaluations/
data-briefs/non-federal-acute-carehospital-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
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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
§ 482.43(c)(8), Proposed § 484.58(a)(6),
and Proposed § 485.642(c)(8))
We proposed at § 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
§ 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
§ 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
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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
§ 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 personcentered 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
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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, publiclyavailable 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
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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/inpatient
rehabilitationfacilitycompare/.
• https://www.medicare.gov/home
healthcompare/search.html.
• https://www.medicare.gov/nursing
homecompare/search.html.
• https://www.medicare.gov/longterm
carehospitalcompare/.
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
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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
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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 § 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 postdischarge 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 selfreferral law in specific circumstances
can be found at https://www.cms.gov/
Medicare/Fraud-and-Abuse/Physician
SelfReferral/advisory_opinions.html and
regarding the application of the antikickback 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
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(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
§§ 482.43(c)(8) and 485.642(c)(8) as
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§§ 482.43(a)(8) and 485.642(a)(8),
respectively, without modification. We
are finalizing and redesignating the
requirements in proposed § 484.58(a)(6)
as § 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
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believe an additional delay in the
effective date for implementation of the
final discharge planning requirements
for HHAs, including the Impact Act
requirements at § 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 § 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
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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 § 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’
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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 nonmedical 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.
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E. Patients’ Rights and Discharge
Planning in Hospitals
1. Patient’s Access to Medical Records
(Proposed § 482.13(d)(2))
In the Hospital Innovation proposed
rule, we proposed clarifying the
requirement for hospitals at
§ 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 https://
www.hhs.gov/hipaa/for-professionals/
privacy/guidance/access/#newly
releasedfaqs.) 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: https://www.hhs.gov/
hipaa/filing-a-complaint/.
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/forprofessionals/faq/2051/under-the-ehrincentive-program-participatingproviders/ and https://
www.hhs.gov/hipaa/for-professionals/
privacy/guidance/access/.
Comment: Commenters were
generally supportive of this proposal.
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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 § 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
§ 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
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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 § 482.43)
We proposed to revise the existing
requirements in the form of 6 standards
at § 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 § 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
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patient transitions from hospital to postacute care while planning for postdischarge 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 personcentered 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 personcentered 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 § 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
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of § 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 postdischarge 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 § 482.43(a))
We proposed to establish a new
standard, at § 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 § 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
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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
§ 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
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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 § 482.43(a)(7) (as originally proposed
at § 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.thinkcultural
health.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
§ 482.43(a).
4. Applicability (Proposed § 482.43(b))
We proposed to revise the current
requirement (§ 482.43(a)), which
requires a hospital to identify those
patients for whom a discharge plan is
necessary at proposed § 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
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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
§ 482.43(b). Instead, we are finalizing
requirements at § 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 § 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.
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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
§ 482.43(b), to be finalized as § 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
§ 482.43(c))
We proposed at § 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 § 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 § 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 § 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
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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 § 482.43(c)(3): We
proposed to retain and clarify the
current requirement at § 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 § 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 § 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 § 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
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informed of the final plan to prepare
them for post-hospital care.
• Proposed § 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 § 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 § 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 § 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 patientprovider 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 § 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
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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
§ 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 § 482.24(c). We are
finalizing the requirement from
proposed § 482.43(c)(3) with
modifications at § 482.43(a)(6) in this
final rule to require regular reevaluation of the patient’s condition to
identify changes that require
modification of the discharge plan. The
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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 hospitalbased 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 multifacility 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 § 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 nonmedical 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
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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 § 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
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appropriate services as well as of the
patient’s access to those services.
We acknowledge that patients and
families seeking post-hospital nonhealth 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 longterm 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-doorguidance.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
https://www.hhs.gov/civil-rights. We
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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
https://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/.
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.
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• 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
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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 § 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 nonhealth 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 § 482.43(c)(5) and on
the final requirements for § 482.43(a)(2)
of this final rule.
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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 § 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,
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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 communitybased 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 § 482.43.
• Revising and redesignating
proposed § 482.43(a), (b), and (c) as
§ 482.43(a) ‘‘Discharge planning
process.’’ As revised, § 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 § 482.43(c).
• Redesignating the requirements in
proposed § 482.43(c)(10) as
§ 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
§ 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 § 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
§ 482.43(a)(5).
• Revising and redesignating
§ 482.43(c)(2) to eliminate the 24-hour
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time frame requirements and retaining,
with minor revisions, the current
requirements at § 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 § 482.43(a).
• Finalizing proposed § 482.43(c)(3)
without modification and redesignating
these requirements as § 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 § 482.43(c)(4).
Revising § 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
§ 482.43(a)(2).
• Revising § 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
§ 482.43(a)(3).
• Modifying § 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 § 482.43.
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• Modifying the requirements at
proposed § 482.43(c)(9) to state that any
discharge planning evaluation must be
made on a timely basis to ensure that
appropriate arrangements for posthospital care will be made before
discharge and to avoid unnecessary
delays in discharge. We are finalizing
these requirements in § 482.43(a)(1).
• We are making a technical revision
to the proposal at § 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
§ 482.43(d))
We proposed to re-designate and
revise the current requirement at
§ 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
§ 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 § 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 § 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 § 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
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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 § 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
§ 482.43(e)(2).
Proposed § 482.43(d)(4): We proposed
to require, for patients discharged to
home, that the hospital establish a postdischarge 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 § 482.43(d)(1), (2), and (4), and
have significantly revised the
requirements of proposed § 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
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supplier, if the patient is referred to
PAC services. Additionally, some
commenters sought clarification
regarding specific issues, such as
whether hospitals could share posthospital 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
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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.thinkcultural
health.hhs.gov/clas/standards.
• https://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 postdischarge 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 § 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
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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 §§ 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
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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, postdischarge 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
§ 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.
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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
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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
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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, postdischarge 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
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51857
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
§ 482.43(f)(1) (finalized here as
§ 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
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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
§ 482.43(d). We are redesignating the
proposed requirement in § 482.43(d)(3)
as § 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, postdischarge 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 § 482.43(e))
We proposed to re-designate and
revise the current standard at
§ 482.43(d) as § 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
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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 prehospital admission/registration
medications (both prescribed and overthe-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
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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 (https://innovation.cms.gov/
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initiatives/CCTP/) 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/engaging
families/strategy4/.
• https://innovations.ahrq.gov/quality
tools/care-transitions-program-toolkit.
• https://caretransitions.org/toolsand-resources/.
• https://www.ahrq.gov/
professionals/systems/hospital/red/
toolkit/.
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 § 482.43(e) to § 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
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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
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51859
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 scopeof-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
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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 subregulatory 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
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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
§ 482.43(e) with modifications. We are
revising and redesignating § 482.43(e)(2)
as follows:
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• Removing proposed § 482.43(c), (d),
and (e) and replacing these standards
with revised and redesignated
§ 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 § 482.43(b) incorporates and
combines revised provisions from the
proposed requirements at § 482.43(c),
(d), and (e).
8. Requirements for Post-Acute Care
(PAC) Services (Proposed § 482.43(f))
We proposed to re-designate and
revise the requirements of current
§ 482.43(c)(6) through (8) at new
§ 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.
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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
§ 482.43(c)(8), now finalized at
§ 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
https://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
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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
§ 482.43(f)(1) to require hospitals
include in the discharge plan, a list of
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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
§ 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 § 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
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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.
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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 laborintensive 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
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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
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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
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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
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website at https://www.cms.gov/
Medicare/Fraud-and-Abuse/Physician
SelfReferral/?redirect=/
PhysicianSelfReferral/. Outside of the
advisory opinion process described at
§§ 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 § 482.43(f) at
§ 482.43(c) without modification.
F. Home Health Agency Discharge
Planning (Proposed § 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 § 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 § 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 postdischarge 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
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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.
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1. Discharge Planning Process (Proposed
§ 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 § 484.55. The discharge plan
would be updated, as needed, to reflect
these changes.
Proposed § 484.58(a)(1) Through (7)
We proposed at § 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 § 484.55. We proposed that the
discharge plan would be updated, as
needed, to reflect these changes. We
proposed at § 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
§ 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 § 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 § 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
§ 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
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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
§ 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
§ 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 § 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
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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
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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
(§ 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
§ 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 § 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 § 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.
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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 § 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
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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
(§ 484.60(e)). We also require at
§ 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.
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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
§ 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 § 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
§ 484.58(a)(2). In accordance with the
requirements of the HHA CoP final rule
at § 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 § 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
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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
§ 484.55(c)(6). Additionally, HHAs must
include caregiver education and training
as part of the plan of care
(§ 484.60(a)(2)(xiii)) and must provide
that training (§ 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.
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Comment: One commenter stated that
the regulation should be specific in
requiring that the updates envisioned in
§ 484.58(a)(1) include re-checking goals
and preferences of the patient. Proposed
§ 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 § 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
§ 484.58(a).
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2. Discharge or Transfer Summary
Content (Proposed § 484.58(b))
We proposed at § 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 overthe-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
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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
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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 healthrelated 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
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proposed requirement at § 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, postdischarge 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.
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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
§ 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 § 484.58(b) to
include only that medical information
pertaining to the patient’s current
course of illness and treatment, postdischarge 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
§ 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
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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
§ 170.315(b)(1) (Transitions of Care) and
§ 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 § 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
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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 § 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
§ 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
§ 484.58(b) with the following
modifications:
• Revising § 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 § 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
§ 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
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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 § 484.58(a),
HHAs will continue to engage in
discharge planning as part of overall
care planning set forth in § 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 § 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
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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 § 484.50(d)
appropriately regulate HHA discharge
and transfer policies to prevent
inappropriate discharges. Specifically,
§ 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 reinstitutionalization.
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 reinstitutionalization 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
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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
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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
§ 484.58.
G. Critical Access Hospital Discharge
Planning (Proposed
§§ 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 § 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 § 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 § 485.642 and one
additional standard at § 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.
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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 nonhealth 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
§ 482.43(f)(1) (regarding transfer to postacute 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
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services.’’ This has been implemented
in the hospital CoPs under
§ 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.
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Proposed § 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 § 485.642(a))
We proposed at § 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
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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 § 485.642(b))
We proposed at § 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
§ 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
§ 485.642(b). Instead, we are finalizing
requirements at § 485.642(a)
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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 § 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 § 485.642(b), and
finalizing as § 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
§ 485.642(c))
We proposed at § 485.642(c),
‘‘Discharge planning process,’’ to
require that CAHs implement a
discharge planning process to begin
identifying the anticipated postdischarge goals, preferences, and
discharge needs of the patient and begin
to develop an appropriate discharge
plan for the patients identified in
proposed § 485.642(b). We proposed at
§ 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
§ 485.642(c)(2) to require that the
discharge planning process begin within
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24 hours after admission or registration
for each applicable patient identified
under the proposed requirement at
§ 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 emergencylevel 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 § 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 § 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 § 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
§ 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
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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 § 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 § 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 § 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 § 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 postCAH 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
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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 § 485.642(c)(10)
to require that the CAH assess its
discharge planning process in
accordance with the existing
requirements at § 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
§ 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
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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
§ 485.642(c) with the following
modifications:
• Revising and redesignating
§ 485.642(c)(2) under § 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
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likely to suffer adverse health
consequences upon discharge if there is
no adequate discharge planning.
• Revising and redesignating
§ 485.642(c)(6) under § 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
§ 485.642(d)(1) Through (3))
We proposed at § 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 § 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 prehospital admission/registration
medications (both prescribed and overthe 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 § 485.642(d)(3) to
require that the CAH send the following
information to the practitioner(s)
responsible for follow-up care, if the
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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 § 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 § 485.642(d)(4) to
require CAHs to establish a postdischarge 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, postdischarge, 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
§ 482.43(d). We are redesignating the
proposed requirement in § 485.642(d)(3)
as § 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.
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5. Transfer of Patients to Another Health
Care Facility (Proposed § 485.642(e))
When a patient is transferred to
another facility, that is, another CAH,
hospital, or a PAC provider, we
proposed at § 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 prehospital admission/registration
medications (both prescribed and overthe-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 § 485.642(e)
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with modifications. We are revising and
redesignating § 485.642 as follows:
• Removing proposed § 485.642(a)
and (b), and replacing these standards
with revisions and redesignating as
§ 485.642(a) titled ‘‘Discharge planning
process.’’ The final standard at
§ 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 § 485.642(c).
• Removing proposed § 485.642(c),
(d), and (e) and replacing these
standards with revisions and
redesignating as § 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
§ 485.642(b) incorporates and combines
revised provisions from the proposed
requirements at § 485.642(c), (d), and
(e).
• Revising § 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
§ 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 §§ 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
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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 § 482.43(a), (b), and (c),
respectively and § 485.642(a), (b), and
(c), and replacing these standards with
revised and redesignated standards at
§§ 482.43(a) and 485.642(a),
respectively, entitled ‘‘Discharge
planning process’’ for each section. The
final standards at §§ 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 §§ 482.43(c)
and 485.642(c), respectively.
• Removing § 482.43(c), (d), and (e)
for hospitals and § 485.642(c), (d), and
(e) for CAHs, and replacing these
standards with revised and redesignated
standards at §§ 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 §§ 482.43(b) and 485.642(b)
incorporate and combine revised
provisions from the proposed
requirements at § 482.43(c), (d), and (e)
for hospitals and § 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, postdischarge 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
§ 482.43(f) at § 482.43(c) without
modification.
HHAs:
• Revising § 484.58 to remove
requirements related to preparing
patients to be active partners in postdischarge care, effective transition of the
patient from HHA to post-HHA care,
and the reduction of factors leading to
preventable readmissions.
• Revising § 484.58(a) to remove
paragraphs (a)(1) through (5) and (7).
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• Revising § 484.58(a) to combine
paragraph (a)(6) with the introductory
statement for paragraph (a).
• Revising § 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 § 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
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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 HHSwide 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 (§ 482.43)
The requirements at § 482.43(a)(8)
(and all similar requirements set out at
§ 485.642(a)(8) for CAHs and § 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,
§ 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 § 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,
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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 (§ 484.58)
We are finalizing a new CoP at
§ 484.58 that will require HHAs to
develop and implement an effective
discharge planning process.
The requirements at § 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 § 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 § 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 ×
0.167 hours) at an approximate cost of
$213.4 million (3,006,000 burden hours
× $71 average hourly salary for a
registered nurse (RN)).
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The cost of sending the discharge
summary to the patient’s next source of
health care services, as required by
§ 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 × .1 affected HHAs
= 1,800,000 patients in affected
HHAs)
(1,800,000 patients in affected HHAs ×
.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 × .25
hours per request) at a cost of
$1,485,000 (45,000 hours × $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 postacute 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.
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C. ICRs Regarding Critical Access
Hospital Discharge Planning (§ 485.642)
Currently, the CoPs at
§ 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
§ 485.635(d)(4) requires the CAH to
develop a nursing care plan for each
inpatient. The Interpretive Guidelines
for § 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 § 485.635(d)(4).
The new requirements at § 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 postCAH care will be made before discharge
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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, postCAH 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 reevaluation 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 postdischarge needs.
The requirement at § 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,
§ 485.642(b) requires CAHs to send
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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
§ 485.642(b)(1) through (6). Currently,
the CoPs at § 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
§ 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.
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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,
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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 rehospitalized.
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
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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 rehospitalized.
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-ASafer-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
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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
§ 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.
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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
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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 $100 million threshold, and
hence also a major rule under the
Congressional Review Act. Accordingly,
we have prepared an RIA that to the best
of our ability presents the costs and
benefits of the rulemaking. This final
rule will create both one-time and
annual costs for hospitals, CAHs and
HHAs. The financial costs are
summarized in Table 1.
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TABLE 1—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES
Number of affected
entities
Provider/supplier and description of proposed provisions
Estimated
costs
($ millions)
Annual
Hospitals (§ 482.43) .................................................................................................................................................
HHAs: Discharge Planning Process(§ 484.58) ........................................................................................................
HHAs: Requests for Information (§ 484.58) ............................................................................................................
4,900
12,600
12,600
(*)
213.4
1.5
Total ..................................................................................................................................................................
........................
214.9
Hospitals (§ 482.43) .................................................................................................................................................
CAHs (§ 485.642) ....................................................................................................................................................
HHAs (§ 484.58) ......................................................................................................................................................
Cost of reviewing final rule ......................................................................................................................................
4,900
1,353
12,600
18,853
17.7
1.9
10.8
16.1
Total ..................................................................................................................................................................
........................
46.5
One-time
* Less than $1 million.
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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 postdischarge 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,
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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 × $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 × $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 × $3,604 ($1,680 plus $568
plus $544 plus $812 = $2,780)).
We are establishing a new standard at
§ 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
§ 484.58(a), which will be a one-time
burden on the HHA. We estimate that
this will require an administrator using
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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 × $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 × $856).
The requirement at § 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 × $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 × $71 for an
RN salary cost). The total burden hours
are 21,648 (16 hours × 1,353 CAHs). For
all CAHs to comply with this
requirement, we estimate a total onetime cost of approximately $1.9 million
(1,353 CAHs × ($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.
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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
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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
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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
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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
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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/
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.
VerDate Sep<11>2014
19:31 Sep 27, 2019
Jkt 247001
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 × 2 staff × $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 × 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 postdischarge 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 postdischarge 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
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51881
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 patientspecific 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 processrecertifications, 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
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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
Primary
estimate
Category
Benefits—Qualitative not quantitative or
monetized .............................................
Low estimate
High estimate
Year dollars
220
220
170
170
280
280
Transfers ..................................................
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
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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.
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2017
2017
7%
3%
2019–2028
2019–2028
None.
In accordance with the provisions of
Executive Order 12866, this rule was
reviewed by the Office of Management
and Budget.
19:31 Sep 27, 2019
Period
covered
Potential Reductions in morbidity, mortality, and medical costs for hospital, HHA, and CAH patients.
Costs—Annualized Monetized Costs of
Discharge Planning to Medical Care
Providers ..............................................
VerDate Sep<11>2014
Discount rate
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
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.
2. Section 482.13 is amended by
revising paragraph (d)(2) to read as
follows:
■
§ 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.
*
*
*
*
*
3. Section 482.43 is revised to read as
follows:
■
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§ 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.
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(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 reevaluation 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 postdischarge 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
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19:31 Sep 27, 2019
Jkt 247001
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 postdischarge 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.
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51883
PART 484—HOME HEALTH SERVICES
4. The authority citation for part 484
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395(hh)
unless otherwise indicated.
5. Section 484.58 is added to read as
follows:
■
§ 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, postdischarge 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
6. The authority citation for part 485
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395(hh).
7. Section 485.635 is amended by
adding paragraph (a)(3)(viii) to read as
follows:
■
§ 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.
*
*
*
*
*
■ 8. Section 485.642 is added to read as
follows:
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§ 485.642 Condition of participation:
Discharge planning.
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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
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19:31 Sep 27, 2019
Jkt 247001
limited to, hospice care services, postCAH 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 reevaluation 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.
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(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, postdischarge 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
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]]>Agencies
[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]
[[Page 51835]]
Vol. 84
Monday,
No. 189
September 30, 2019
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Table of Contents
I. Background
A. Overview
B. IMPACT Act
II. Provisions of the Proposed Regulations and Responses to Public
Comments
A. General Comments
B. Discharge Planning Requirements of the IMPACT Act of 2014
(Proposed Sec. 482.43(c)(8), Proposed Sec. 484.58(a)(6), and
Proposed Sec. 485.642(c)(8))
C. Implementation
D. Prescription Drug Monitoring Programs (PDMPs)
E. Patients' Rights and Discharge Planning in Hospitals
1. Patient's Access to Medical Records (Proposed Sec.
482.13(d)(2))
2. Conditions of Participation (CoP)--Discharge Planning
(Proposed Sec. 482.43)
3. Design (Proposed Sec. 482.43(a))
4. Applicability (Proposed Sec. 482.43(b))
5. Discharge Planning Process (Proposed Sec. 482.43(c))
6. Discharge to Home (Proposed Sec. 482.43(d))
7. Transfer of Patients to Another Health Care Facility
(Proposed Sec. 482.43(e))
8. Requirements for Post-Acute Care (PAC) Services (Proposed
Sec. 482.43(f))
F. Home Health Agency Discharge Planning (Proposed Sec. 484.58)
1. Discharge Planning Process (Proposed Sec. 484.58(a))
2. Discharge or Transfer Summary Content (Proposed Sec.
484.58(b))
G. Critical Access Hospital Discharge Planning (Proposed Sec.
485.642)
1. Design (Proposed Sec. 485.642(a))
2. Applicability (Proposed Sec. 485.642(b))
3. Discharge Planning Process (Proposed Sec. 485.642(c))
4. Discharge to Home (Proposed Sec. 485.642(d)(1) through (3))
5. Transfer of Patients to Another Health Care Facility
(Proposed Sec. 485.642(e))
III. Provisions of the Final Regulations
IV. Collection of Information Requirements
A. ICRs Regarding Hospital Discharge Planning (Sec. 482.43)
B. ICRs Regarding Home Health Discharge Planning (Sec. 484.58)
C. ICRs Regarding Critical Access Hospital Discharge Planning
(Sec. 485.642)
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
D. Alternatives Considered
E. Cost to the Federal Government
F. Accounting Statement
G. Regulatory Reform Analysis Under Executive Order 13771
H. Congressional Review Act
I. Background
A. Overview
On November 3, 2015, we published a proposed rule that would update
the discharge planning requirements for hospitals, critical access
hospitals (CAHs), and post-acute care (PAC) settings (80 FR 68126).
Discharge planning is an important component of a successful transition
from hospitals and PAC settings. The transition may be to a patient's
home (with or without PAC services), skilled nursing facility (SNF),
nursing facility (NF), long term care hospital (LTCH), rehabilitation
hospital or unit, assisted living center, substance abuse treatment
program, hospice, or a variety of other settings. While Medicare
regulations define ``post-acute care'' providers to include SNFs,
LTCHs, inpatient rehabilitation facilities (IRFs) and home health
agencies (HHAs), it should be noted that there are other services that
can be provided by entities other than PAC providers (that is, LTCHs,
IRFs, HHAs, and SNFs), including assisted living facilities, home and
community-based services, or primary care providers. The location to
which a patient may be discharged should be based on the patient's
clinical care requirements, available support network, and patient and
caregiver treatment preferences and goals of care.
We also proposed to implement the discharge planning requirements
of the Improving Medicare Post-Acute Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113-185), that requires hospitals, including, but
not limited to, short-term acute care hospitals, CAHs and PAC providers
(LTCHs, IRFs, HHAs, and SNFs), to take into account quality measures
and resource use measures to assist patients and their families during
the discharge planning process in order to encourage patients and their
families to become active participants in the planning of their
transition to the PAC or other settings (or between such settings).
We published another proposed rule on June 16, 2016 in the Federal
Register, titled ``Medicare and Medicaid Programs; Hospital and
Critical Access Hospital (CAH) Changes to Promote Innovation,
Flexibility, and Improvement in Patient Care'' (81 FR 39448),
hereinafter referred to as the ``Hospital Innovation proposed rule'',
that proposed to update a number of Conditions of Participation (CoP)
requirements that hospitals and CAHs must meet in order to participate
in the Medicare and Medicaid programs. One of the proposed hospital CoP
revisions in that rule directly addresses the issues
[[Page 51837]]
of communication between providers and patients and patient access to
their medical records. We proposed that patients have the right to
access their medical records, upon an oral or written request, in the
form and format requested by such patients, if it is readily producible
in such form and format (including in an electronic form or format when
such medical records are maintained electronically); or, if not, in a
readable hard copy form or such other form and format as agreed to by
the facility and the patient, including current medical records, within
a reasonable time frame. The hospital could not frustrate the
legitimate efforts of patients to gain access to their own medical
records and would have to actively seek to meet these requests as
quickly as its record keeping system permitted.
In accordance with Executive Order 13813, which promotes healthcare
choice and competition across the country, and in line with HHS' goals
to improve interoperability between patients and their health care
providers, we are finalizing certain discharge planning requirements
for hospitals (including Short-Term Acute-Care Hospitals, LTCHs,
Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals,
and Cancer Hospitals), HHAs, and CAHs as well as finalizing the
hospital patients' rights requirement regarding patient access to
medical records. We are also finalizing the requirements of the IMPACT
Act for hospitals, HHAs, and CAHs. We believe that these final
requirements will empower patients to be active participants in the
discharge planning process and will help them to make informed choices
about their care, which may lead to more competition, lower costs, and
improved quality of care. Furthermore, the IMPACT Act requirements will
give patients and their families access to information that will help
them to make informed decisions about their post-acute care, while
addressing their goals of care and treatment preferences. Patients and
their families who are well informed of their choices of high-quality
PAC providers may reduce their chances of being re-hospitalized.
We also believe these final requirements will complement efforts
around interoperability that focus on the seamless exchange of patient
information between health care settings. Ultimately, these final
requirements will ensure that a patient's health care information
follows them after discharge from a hospital or PAC provider to their
receiving health care facility, medical professional, or caregiver, as
applicable.
B. IMPACT Act
The IMPACT Act requires the standardization of PAC assessment data
that can be evaluated and compared across PAC provider settings, and
used by hospitals, CAHs, and PAC providers, to facilitate coordinated
care and improved Medicare beneficiary outcomes. Section 2 of the
IMPACT Act added section 1899B to the Social Security Act (the Act).
Section 1899B of the Act states that the Secretary of the Department of
Health and Human Services (the Secretary) must require PAC providers
(that is, HHAs, SNFs, IRFs, and LTCHs) to report standardized patient
assessment data, data on quality measures, and data on resource use and
other measures. Under section 1899B(a)(1)(B) of the Act, patient
assessment data must be standardized and interoperable to allow for the
exchange of data among PAC providers and other Medicare participating
providers or suppliers. Section 1899B(a)(1)(C) of the Act requires the
modification of existing PAC assessment instruments to allow for the
submission of standardized patient assessment data to enable comparison
of this assessment data across providers. The IMPACT Act requires that
assessment instruments be modified to utilize the standardized data
required under section 1899B(b)(1)(A) of the Act, no later than October
1, 2018 for SNFs, IRFs, and LTCHs and no later than January 1, 2019 for
HHAs. The statutory timing of the IMPACT Act varies for the
standardized assessment data described in subsection (b) of the Act,
data on quality measures described in subsection (c) of the Act, and
data on resource use and other measures described in subsection (d) of
section 1899B of the Act. We note that many of these PAC provisions are
being addressed in separate rulemakings. More information can be found
on the CMS website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html.
Section 1899B(j) of the Act requires that we allow for stakeholder
input, such as through town hall meetings, open door forums, and
mailbox submissions, before the initial rulemaking process to implement
section 1899B of the Act. To meet this requirement, we provided the
following opportunities for stakeholder input: (1) On February 3, 2015
we convened a technical expert panel (TEP) to gather input on three
cross-setting measures identified as potential measures to the
requirements of the IMPACT Act, that included stakeholder experts and
patient representatives; (2) provided two separate listening sessions
on February 10 and March 24, 2015 on the implementation of the IMPACT
Act, which also gave the public the opportunity to give CMS input on
their current use of patient goals, preferences, and health assessment
information in assuring high quality, person-centered and coordinated
care enabling long-term, high quality outcomes; (3) in January 2015 we
implemented a public mail box for the submission of comments located at
[email protected]. The CMS public mailbox can be
accessed on our PAC quality initiatives website: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/Submit-a-Question-or-Feedback.html; (4) held a National Stakeholder Special Open Door Forum
on February 25, 2015 to seek input on the measures; and (5) sought
public input during the February 2015 ad hoc Measure Applications
Partnership (MAP) process meeting regarding the measures under
consideration with respect to the IMPACT Act domains. Section 1899B(i)
of the Act, which addresses discharge planning, requires the
modification of the CoPs, and subsequent interpretive guidance
applicable to PAC providers, hospitals, and CAHs at least every 5
years, beginning no later than January 1, 2016. These regulations must
require that PAC providers, hospitals, and CAHs take into account
quality, resource use, and other measures under subsections (c) and (d)
of section 1899B of the Act in the discharge planning process.
We proposed to implement the discharge planning requirements
mandated in section 1899B(i) of the Act by modifying the discharge
planning or discharge summary CoPs for hospitals, CAHs and HHAs. As
stated above, the IMPACT Act added section 1899B to the Act. The IMPACT
Act identifies LTCHs and IRFs as PAC providers, but the hospital CoPs
also apply to LTCHs and IRFs since these facilities, along with short-
term acute care hospitals (including their Inpatient Prospective
Payment System (IPPS), excluded rehabilitation or psychiatric units),
rehabilitation hospitals, psychiatric hospitals, children's hospitals,
and cancer hospitals) are all classifications of hospitals. All
classifications of hospitals (as well as distinct part
[[Page 51838]]
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
[[Page 51839]]
provider types would be required to comply with the discharge planning
CoPs. One commenter requested clarification as to whether the proposed
requirements would apply to partial hospitalization and intensive
outpatient programs at hospitals.
Response: All classifications of hospitals except CAHs are
regulated under part 482 of our regulations, and are subject to the
same set of hospital CoPs. We further clarified that the PAC providers
mentioned in the IMPACT Act, specifically LTCHs and IRFs, would also be
subject to the proposed revision to the hospital CoPs. We did not list
all the classifications of hospitals in the proposed rule since we
specifically focused on the PAC providers mentioned in the IMPACT Act,
but we understand the importance of delineating which hospital types
would have to comply with the hospital discharge planning CoPs, since
they were not explicitly mentioned in the proposed rule. Therefore, we
are clarifying that these final discharge planning requirements apply
to all classifications of hospitals, including short-term acute care
hospitals (including their IPPS-excluded rehabilitation or psychiatric
units), psychiatric hospitals, LTCHs, rehabilitation hospitals,
children's hospitals, and cancer hospitals. Throughout this final rule,
we clarify that where the term ``hospital'' is used, we are referring
to the aforementioned hospital classifications. These requirements
would also apply to distinct part psychiatric and rehabilitation units
in CAHs.
Although these discharge planning requirements apply to psychiatric
hospitals, there are several additional currently existing discharge
planning requirements specific to psychiatric hospitals that are not
affected by the discharge planning requirements discussed in this rule.
Thus, psychiatric hospitals will still be required to meet the
additional special provisions, special medical record requirements, and
special staff requirements set out at Sec. Sec. 482.60, 482.61, and
482.62.
Inpatient psychiatric units located in a hospital, (as opposed to
psychiatric hospitals) are specialized units within a larger hospital
or CAH. Inpatient psychiatric units must meet the hospital CoP
requirements for the hospitals in which they are located. However, they
are not required to meet the CoPs specific to psychiatric hospitals set
out at Sec. Sec. 482.60, 482.61, and 482.62. Therefore, these
discharge planning requirements apply to inpatient psychiatric units
located within a hospital or a CAH. The additional, currently existing,
discharge planning requirements for psychiatric hospitals do not apply
to inpatient psychiatric units. Note that ``inpatient psychiatric
facility'' is a CMS classification used to refer to both psychiatric
hospitals and inpatient psychiatric excluded units of hospitals and
inpatient psychiatric distinct part units of CAHs; however, psychiatric
excluded and distinct part units in hospitals and CAHs are not subject
to the requirements under Sec. Sec. 482.60, 482.61, and 482.62.
In response to the commenter's request for clarification regarding
partial hospitalization services and intensive outpatient services at
hospitals, we note that these services can be provided in a hospital
outpatient department, and partial hospitalization services can be
provided in a community mental health center. These discharge planning
requirements however would not apply to services provided to patients
in a community health center.
Comment: Several commenters were concerned that durable medical
equipment (DME) requirements were not specifically required in the
discharge planning proposed rule. The commenters explained that
providers should address and document a patient's DME needs during the
discharge planning process. A few commenters also noted that DME was
not addressed in the Meaningful Use Stage 3 requirements (80 FR 62761,
which is discussed in our response here), and thus is still largely in
paper format.
Response: We agree that considering a patient's DME needs when
planning for a patient's post-hospital care is a best practice. While
we are not mandating that providers include information on a patient's
DME needs in the patient's discharge instructions at this time, we
encourage providers to do so where appropriate. However, comments
regarding specific Stage 3 Meaningful Use requirements are not within
the purview of these CoPs.
Comment: One commenter noted the absence of proposed discharge
planning requirements for SNFs in the Discharge Planning proposed rule.
One commenter requested that CMS require nursing homes to provide
patients with prescriptions before the patient returns home or back to
the community. One commenter suggested that LTC facilities and
rehabilitation facilities have a social worker with a Master of Science
in Management (MSM), Licensed Clinical Social worker (LCSW), or a
Master's degree in Gerontology. Another commenter recommended that each
state expand the number of nursing facility/acute hospital Medicaid
demonstration programs that will allow individuals with disabilities to
live in the community.
Response: Comments regarding LTC facilities and Medicaid
demonstration programs are outside the scope of this final rule. The
discharge planning requirements for SNFs were addressed in the Long-
Term Care (LTC) Facility Requirements final rule (81 FR 68688, October
4, 2016) and Sec. 483.21(c) of the SNF requirements, which addresses
discharge planning.
Comment: A few commenters recommended that if CMS finalizes the
proposed requirements, the final regulation and sub-regulatory guidance
should not focus on the process of discharge planning alone, but allow
providers greater flexibility to ensure their efforts are meaningful
and adaptable over time. One commenter believed that the proposed rule
included too many details on the discharge planning process instead of
focusing on outcomes, which the commenter stated, could lead to
``performing to the test'' activities that inhibit innovation. The
commenter noted that the goals of the regulations should instead be
focused on holding providers responsible for outcomes and not the
processes of care. The commenter noted that CMS already has several
programs that focus on outcomes, including value-based payment plans
and hospital compare and star rating systems. The commenter ultimately
believed that providers should use these mechanisms to drive innovation
and lead to the best possible outcomes.
Another commenter expressed concern over the potential impact of
the proposed requirements on currently existing state innovation
programs aimed at adopting value-based payment. The commenter
recommended that CMS review the proposed changes to the CoPs, with
support for state flexibility for innovation. Finally, another
commenter noted that providers would need support in implementing and
understanding the finalized discharge planning requirements.
Response: We understand the commenters' concerns and have revised
most of the proposed requirements in this final rule to focus less on
prescriptive and burdensome process details, and more on patient
outcomes and treatment preferences through the use of enhanced
information exchange and innovative practice standards. We encourage
hospitals, HHAs, and CAHs to actively engage with patients to create a
more meaningful discharge planning process. We believe these
requirements will afford patients the opportunity to
[[Page 51840]]
be active participants in the discharge planning process. In addition,
in order to encourage patient engagement and understanding of their
discharge plan or instructions, we recommend that providers follow the
National Standards for Culturally and Linguistically Appropriate
Services (CLAS) in Health and Health Care (https://www.thinkculturalhealth.hhs.gov/clas/standards), which provide guidance
on providing instructions in a culturally and linguistically
appropriate manner. We also remind providers of their obligations take
reasonable steps to provide meaningful access to individuals with
limited English proficiency in accordance with Title VI of the Civil
Rights Act of 1964 and section 1557 of the Patient Protection and
Affordable Care Act (the Affordable Care Act). In addition, providers
are reminded to take appropriate steps to ensure effective
communication with individuals with disabilities, including the
provision of auxiliary aids and services, in accordance with section
504 of the Rehabilitation Act, the Americans with Disabilities Act, and
section 1557 of the Affordable Care Act (see, https://www.hhs.gov/civil-rights and https://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
(https://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 https://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: https://www.hhs.gov/hipaa/filing-a-complaint/. 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/ and https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
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 https://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 https://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/.
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.
https://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 (https://innovation.cms.gov/
[[Page 51859]]
initiatives/CCTP/) 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/.
https://innovations.ahrq.gov/qualitytools/care-transitions-program-toolkit.
https://caretransitions.org/tools-and-resources/.
https://www.ahrq.gov/professionals/systems/hospital/red/toolkit/.
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 https://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/?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
