[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Proposed Rules]
[Pages 40350-40404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14153]
[[Page 40349]]
Vol. 87
Wednesday,
No. 128
July 6, 2022
Part II
Department of Health and Human Services
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Food and Drug Administration
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42 CFR Parts 485 and 489
Medicare and Medicaid Programs; Conditions of Participation (CoPs) for
Rural Emergency Hospitals (REH) and Critical Access Hospital CoP
Updates; Proposed Rule
Federal Register / Vol. 87 , No. 128 / Wednesday, July 6, 2022 /
Proposed Rules
[[Page 40350]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 485 and 489
[CMS-3419-P]
RIN 0938-AU92
Medicare and Medicaid Programs; Conditions of Participation
(CoPs) for Rural Emergency Hospitals (REH) and Critical Access Hospital
CoP Updates
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would establish conditions of participation
that Rural Emergency Hospitals (REH) must meet to participate in the
Medicare and Medicaid programs. These requirements are intended to
ensure that a high quality of care is furnished by REHs. This proposed
rule also includes changes to the requirements Critical Access Hospital
would have to meet to participate in the Medicare and Medicaid
programs. Proposed payment policies and enrollment policies for REHs
will be developed under separate rulemaking.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below by August 29, 2022.
ADDRESSES: In commenting, please refer to file code CMS-3419-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3419-P, P.O. Box 8016,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3419-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Kianna Banks, (410) 786-3498.
Capt. Scott Cooper, U.S. Public Health Service (USPHS), (410) 786-
9465.
Kristin Shifflett, (410) 786-4133.
Lela Strong, (410) 786-3213.
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. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
A. Introduction
Americans who live in rural areas of the nation make up about 20
percent of the United States (U.S.) population, and they often
experience shorter life expectancy, higher all-cause mortality, higher
rates of poverty, fewer local doctors, and greater distances to travel
to see health care providers, compared to their urban and suburban
counterparts.\1\ In addition, one in five rural residents identifies as
Black, Hispanic, American Indian/Alaska Native (AI/AN), Asian American/
Pacific Islander (AA/PI), or a combination of ethnic backgrounds.
Compared to the non-Hispanic White rural population, these rural
minority groups often and regularly experience several disadvantageous
social determinants of health.\2\
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\1\ Rural Health Research Gateway. (2018). Rural Communities:
Age, Income, and Health Status. https://www.ruralhealthresearch.org/assets/2200-8536/rural-communities-age-income-health-status-recap.pdf.
\2\ Health Resources & Services Administration (2021). Rural
Hospital Programs. https://www.hrsa.gov/rural-health/rural-hospitals/.
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The health care inequities that many rural Americans face raise
serious concerns that the trend for poor health care access and worse
outcomes overall in rural areas will continue unless the potential
causes of such health care inequities are addressed.
There have been growing concerns over the closures of rural
hospitals and critical access hospitals (CAHs). Between 2010 and
February 2022, 138 rural hospitals stopped providing inpatient
services, 44 of which were Critical Access Hospitals. There were 75
complete hospital closures where all services ended and 63 hospital
conversions where inpatient services ended but some type of health care
service continued.\3\ Rural hospitals report they continue to face the
threat of closure because they lack sufficient patient volume to offer
traditional hospital inpatient acute care services required for
Medicare payment; however, the demand still exists for emergency and
outpatient services in areas served by these hospitals. Rural hospitals
are essential to providing health care to their communities and the
closure of these hospitals limits access to care for the communities
they once served and reduces employment opportunities, further
impacting local economies. Barriers such as workforce shortages, can
impact health care access in rural communities and can lead to unmet
health needs, delays in receiving appropriate care, inability to get
preventive services, financial burdens, and preventable
hospitalizations.\4\
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\3\ UNC: Cecil G. Sheps Center for Health Services Research.
(2022). Rural Hospital Closures. https://www.shepscenter.unc.edu/programs-projects/rural-health/rural-hospital-closures/.
\4\ Healthy People 2020 (n.d.) Access to Health Services.
https://www.healthypeople.gov/2020/topics-objectives/topic/Access-to-Health-Services.
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The Consolidated Appropriations Act (CAA) of 2021 (Pub. L. 116-
260), was signed into law on December 27, 2020. In this legislation,
Congress established a new rural Medicare provider type: Rural
Emergency Hospitals (REHs). These providers will furnish emergency
department and observation care, and other specified outpatient medical
and health services, if elected by the REH, that do not exceed an
annual per patient average of 24 hours. Hospitals that were CAHs or
rural hospitals with not more than 50 beds, participating in Medicare,
as of the date of enactment of the CAA, may submit an application to
convert to and enroll in Medicare as an REH. An REH will receive
Medicare payment for REH services furnished on or after January 1,
2023.
REHs are expected to help address the barriers in access to health
care, particularly emergency services and other outpatient services
that result
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from rural hospital closures, and by doing so, may help address
observed inequities in health care in rural areas.
On January 20 and 21, 2021, President Biden issued three Executive
orders related to issues of health equity: Executive Order 13985
``Advancing Racial Equity and Support for Underserved Communities
Through the Federal Government;'' \5\ Executive Order 13988,
``Preventing and Combating Discrimination on the Basis of Gender
Identity or Sexual Orientation;'' \6\ and Executive Order 13995
``Ensuring an Equitable Pandemic Response and Recovery.'' \7\
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\5\ 86 FR 7009 (Jan. 25, 2021). The White House. (2021).
Briefing Room: Executive Order on Advancing Racial Equity and
Support for Underserved Communities Through the Federal Government.
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-andsupport-for-underserved-communities-through-thefederal-government/.
\6\ 86 FR 7023 (Jan. 25, 2021). The White House. (2021).
Briefing Room: Executive Order on Preventing and Combating
Discrimination on the Basis of Gender Identity or Sexual
Orientation. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-preventing-and-combatingdiscrimination-on-basis-of-gender-identity-orsexual-orientation/.
\7\ 86 FR 7193 (Jan. 26, 2021). The White House. (2021).
Briefing Room: Executive Order on Ensuring an Equitable Pandemic
Response and Recovery. https://www.whitehouse.gov/briefing-room/presidentialactions/2021/01/21/executive-order-ensuring-anequitable-pandemic-response-and-recovery/.
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Executive Order 13985, ``Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government,'' requires the
Federal Government to pursue a comprehensive approach to advancing
equity for all, including people of color and others who have been
historically underserved, marginalized, and adversely affected by
persistent poverty and inequality by recognizing and working to redress
inequities in its policies and programs that serve as barriers to equal
opportunity. In accordance with this Executive order, persons who live
in rural areas are identified as belonging to underserved communities
that have been adversely affected by inequality.
Executive Order 13988, ``Preventing and Combating Discrimination on
the Basis of Gender Identity or Sexual Orientation,'' requires the
Federal Government to prevent and combat discrimination, including when
accessing health care, on the basis of gender identity or sexual
orientation, and to fully enforce Title VII of the Civil Rights Act.
This Executive order also requires the Federal Government to fully
enforce other laws that prohibit discrimination on the basis of gender
identity or sexual orientation, all of which impact all persons,
including those in rural communities.
In accordance with Executive Order 13995, ``Ensuring an Equitable
Pandemic Response and Recovery,'' the Federal Government must identify
and eliminate health and social inequities resulting in
disproportionately higher rates of exposure, illness, and death related
to COVID-19 and take swift action to prevent and remedy differences in
COVID-19 care and outcomes within communities of color and other
underserved populations. The Executive order highlights the observed
inequities in rural and Tribal communities, territories, and other
geographically isolated communities. We believe the services furnished
by REHs, could be one means of addressing some of the issues raised in
these orders, particularly, barriers to access health care in rural
communities.
Consistent with these Executive orders, in implementing the new REH
provider type, we are committed to advancing equity for all, including
racial and ethnic minorities, members of the lesbian, gay, bisexual,
transgender, and queer/questioning (LGBTQ) community, people with
limited English proficiency, people with disabilities, rural
populations, and people otherwise adversely affected by persistent
poverty or inequality.
We are proposing at this time to establish conditions of
participation (CoPs) for REHs as a new Medicare provider type,
consistent with the provisions of section 125 of the CAA. In developing
the proposed CoPs for REHs, we have considered the role that we believe
REHs can play in helping to advance equity and ensure access to
available services and quality health care in rural communities.
Proposed payment and enrollment policies for REHs will be developed in
separate rulemaking.
B. Statutory Authority and Establishment of Rural Emergency Hospitals
as a Medicare Provider Type
Section 125 of Division CC of the CAA was signed into law on
December 27, 2020 and establishes REHs as a new Medicare provider type
that will receive Medicare payment for services furnished on or after
January 1, 2023. Section 125 of the CAA added section 1861(kkk) to the
Social Security Act (the Act), which sets forth the requirements for
REHs. Section 1861(kkk)(2) of the Act defines an REH as a facility that
is enrolled in the Medicare program as an REH; does not provide any
acute care inpatient services (other than post-REH, that is after
discharge from an REH, or post-hospital extended care services
furnished in a distinct part unit licensed as a skilled nursing
facility (SNF)); has a transfer agreement in effect with a level I or
level II trauma center; meets certain licensure requirements; meets
requirements of a staffed emergency department; meets staff training
and certification requirements established by the Secretary of the
Department of Health and Human Services (the Secretary); and meets
certain CoPs applicable to hospital emergency departments and CAHs with
respect to emergency services.
Additionally, section 125(a)(1) of the CAA added section
1861(kkk)(1) of the Act, which requires that REHs provide emergency
department services and observation care, and, at the election of the
REH, other medical and health services furnished on an outpatient
basis, as specified by the Secretary through rulemaking. The REH must
also have a staffed emergency department 24 hours a day, 7 days a week,
have a physician, nurse practitioner, clinical nurse specialist, or
physician assistant available to furnish rural emergency hospital
services in the facility 24 hours a day, and meet applicable staffing
requirements similar to those for CAHs.\8\
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\8\ Congress.gov. (2020). H.R.133--Consolidated Appropriations
Act, 2021. https://www.congress.gov/116/bills/hr133/BILLS-116hr133enr.pdf.
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In order to become an REH, section 1861(kkk)(3) of the Act requires
that the facility, on the date of enactment of the CAA, 2021 (December
27, 2020), was a CAH or a rural hospital with not more than 50 beds.
For the purpose of REH designation, the statute defines rural as a
county (or equivalent unit of local government) considered rural (as
defined in section 1886(d)(2)(D) of the Act), or treated as being
located in a rural area pursuant to section 1886(d)(8)(E) of the Act.
To be treated as being located in a rural area for the purpose of REH
eligibility, we are proposing as part of this proposed rule that a
hospital located in a metropolitan county must have had an active
reclassification from urban to rural status as specified in 42 CFR
412.103 as of December 27, 2020. In addition, the REH must meet certain
other requirements under section 1861(kkk) of the Act, including, but
not limited to the following:
An annual per patient average of 24 hours or less in the
REH;
Staff training and certification requirements established
by the Secretary;
Emergency services CoPs applicable to CAHs;
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Hospital emergency department CoPs determined applicable
by the Secretary;
The applicable SNF requirements (if the REH includes a
distinct part SNF);
A transfer agreement with a level I or level II trauma
center; and
Any other requirements the Secretary finds necessary in
the interest of the health and safety of individuals who are furnished
services in an REH.
Starting on January 1, 2023, an REH that provides rural emergency
hospital services (as defined in section 1861(kkk)(1) of the Act) will
receive a Medicare payment for those services pursuant to section
1834(x)(1) of the Act, as added by section 125 of the CAA, that is
equal to the amount of payment that would otherwise apply under the
Medicare Hospital Outpatient Prospective Payment System (OPPS) for
covered outpatient department services increased by 5 percent. The
beneficiary co-payments for these services will be calculated the same
way as under the OPPS for the service, excluding the 5 percent payment
increase. In addition, section 1834(x)(2) of the Act provides an
additional monthly facility payment to an REH. The details of the
payment policies for REHs will be developed in separate notice and
comment rulemaking.
To participate in the Medicare program and receive payment for
services furnished to Medicare beneficiaries, providers of services
such as hospitals, home-health agencies, hospices, SNFs, and now REHs
must enter into a provider agreement with Centers for Medicare &
Medicaid Services (CMS), in accordance with section 1866 of the Act.
Medicaid providers (every person or institution providing services
under the state plan), likewise, must enter into agreements with state
Medicaid agencies to be eligible for participation in that program as
described in section 1902(a)(27) of the Act. By entering into a
provider agreement, a facility agrees that it will comply with the
applicable requirements of the Medicare and Medicaid statutes and the
regulations that the Secretary issues under the respective statute.
Section 1861(kkk)(7) of the Act requires the Secretary to establish
quality measurement reporting requirements for REHs, which may include
claims-based outcome measures and/or patient experience surveys. An REH
is required to submit quality measure data to the Secretary with
respect to each year beginning in 2023 (or each year beginning on or
after the date that is one year after one or more measures are first
specified), and the Secretary is required to establish procedures to
make the data available to the public on the CMS website. Quality
measure specifications and quality reporting requirements for REHs will
be developed in future rulemaking.
The Quality Improvement Organization requirements of the Act shall
apply to REHs in the same manner that they apply to hospitals and CAHs,
in accordance with section 1866(a) of the Act (as amended by section
125(b)(1) of the CAA). In addition, the requirements established at
section 1864 of the Act for hospitals and CAHs to be surveyed for
compliance with the CoPs shall apply to REHs in the same manner as
other hospitals and CAHs, in accordance with section 125(d)(2) of the
CAA.
Under section 1864 of the Act, CMS uses state surveyors to
determine whether a provider or supplier subject to certification
qualifies for an agreement to participate in Medicare. Additionally,
under section 1865 of the Act, some providers or suppliers subject to
certification have the option to instead elect to be accredited by
private accrediting organizations (AOs) whose Medicare accreditation
programs have been approved by CMS as having standards and survey
procedures that meet or exceed all applicable Medicare requirements and
be deemed to meet Federal requirements. The survey process for
Medicare- and Medicaid-participating providers and suppliers provides
an opportunity for these providers and suppliers to demonstrate
compliance with all of the applicable CoPs, conditions for coverage
(CfCs), conditions for certification, or requirements. The methods used
by CMS to determine compliance with the regulations include surveys
conducted by a state survey agency, surveys conducted by AOs that have
deeming authority for Medicare providers and suppliers, and self-
attestation. CMS would require REHs participating in Medicare to
demonstrate and maintain compliance with the provisions included in the
final rule.
C. Summary of Comments by Interested Parties in Response to REH Request
for Information
In preparation for developing these proposed standards and to gain
a clear understanding of the challenges faced by facilities providing
health care services in rural communities, we published a Request for
Information (RFI) on REHs in the proposed rule, ``Medicare Program:
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center
Payment Systems and Quality Reporting Programs; Price Transparency of
Hospital Standard Charges; Radiation Oncology Model; Request for
Information on Rural Emergency Hospitals'' (86 FR 42018) on August 4,
2021. CMS sought public input on a broad range of issues to inform our
policymaking in establishing this new provider type. The RFI solicited
public input on the concerns of rural providers, including in the areas
of health and safety standards, health equity, payment policies,
quality measures and quality reporting, and additional considerations
and unintended consequences that should be considered during the
development of standards for REHs. As previously noted in section I.B
of this proposed rule, the details of the payment policy and quality
measures and quality reporting requirements for REHs will be developed
via future rulemaking.
Commenters on the RFI generally noted that CMS should remain
flexible in the development of standards for REHs and take into
consideration the challenges associated with the provisi0on of health
care services in rural communities. Specific themes from the comments
received centered on suggested CoPs including requirements for
staffing, transfers, and supervision, services that should be offered
by REHs, and the health equity implications for REHs. Several
commenters stated that the CoPs currently in place for CAHs would be
sufficient for REHs and that the CoPs for REHs should not be more
rigorous than those for CAHs. Commenters also recommended that REHs
should provide maternal health, behavioral/mental health services, and
telehealth services to further support the communities that they will
serve. With regard to health equity, several interested parties
commented that REHs could have significant value for underserved, rural
populations by maintaining local access to care, reducing travel times
for care, and serving as leaders for community health improvement
efforts including efforts to address the social determinants of health.
We note that CMS is committed to reducing inequities in rural
communities and we are considering the best approach to address health
equity in the standards for all Medicare-and Medicaid-participating
providers and suppliers, including REHs.
The REH RFI public comments are available for review at https://www.regulations.gov/document/CMS-2021-0124-0002/comment. We have
reviewed all comments from interested parties and have taken them into
consideration while drafting this
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proposed rule. We appreciate the interested parties' input and
responses to our outreach efforts thus far.
During the development of the policies to implement this new
provider type, we reviewed the public comments received on the REH RFI,
and held public listening sessions with national organizations
representing interested parties as well as tribal communities. We also
gave presentations at CMS' hospital, rural health, and SNF open door
forums and sought public feedback. We carefully reviewed the hospital
and CAH requirements to determine which requirements would be
appropriate (as is or based on modification) for REHs.
II. Provisions of the Proposed Regulation
A. Rural Emergency Hospital Conditions for Participation (Proposed Part
485, Subpart E)
We propose to add a new subpart E in 42 CFR part 485, to
incorporate the REH CoPs. Proposed subpart E which would include all
the health and safety standards for REHs. Overall, the proposed
requirements are modeled closely after the CoPs for CAHs. In some
instances, we have also proposed requirements that are similar to the
CoPs for hospitals and CfCs for Ambulatory Surgical Centers (ASCs). In
each of the sections below, we specify the existing requirements for
CAHs, hospitals, or ASCs that we used to guide the proposed
requirements.
1. Basis and Scope (Proposed Sec. 485.500)
We propose to set forth the basis and scope of part 485, subpart E,
at Sec. 485.500. As previously noted, proposed part 485, subpart E,
would implement section 1861(kkk) of the Act, which establishes the
requirements that an REH must meet in order to participate in the
Medicare program. Section 1833(a) of the Act serves as the basis for
the establishment of payment of benefits covered under Medicare for
REHs.
2. Definitions (Proposed Sec. 485.502)
At Sec. 485.502, we propose to define certain terms that would be
used throughout the REH CoPs. We propose to define the term ``Rural
Emergency Hospital or REH'' in accordance with the definition set forth
in section 1861(kkk) of the Act. In accordance with the Act, we propose
to define Rural Emergency Hospital or REH as an entity that operates
for the purpose of providing emergency department services, observation
care, and other outpatient medical and health services specified by the
Secretary in which the annual per patient average length of stay does
not exceed 24 hours. The REH must not provide inpatient services,
except those furnished in a unit that is a distinct part licensed as a
skilled nursing facility to furnish post-REH or post-hospital extended
care services.
We received several comments on the REH RFI indicating that the
average length of stay should be increased in certain instances, such
as when the REH is providing services to a patient who is need of
inpatient psychiatric or inpatient rehabilitation services. The
commenters stated that placement of these patients in an inpatient
facility could be difficult with some patients potentially remaining in
the REH for observation services for weeks. Commenters noted further
that these patients may produce an average length of stay that exceeds
the proposed 24-hour annual per patient average length of stay. Other
commenters requested that CMS be flexible in recognizing bed capacity
issues for those patients awaiting placement in an inpatient facility
and practice enforcement discretion related to the proposed length of
stay requirement.
However, in accordance with section 1861(kkk)(1)(A) of the Act,
services furnished by the REH must not exceed an annual per patient
average of 24 hours in the REH. We would expect an REH to transfer
patients whom the REH determines require a higher level of care as soon
as possible. We do understand that there may be occasional
circumstances in which a facility is not immediately available to
provide a higher level of care, resulting in patients receiving
services at the REH for more than 24 hours. However, we believe that
this will occur at a frequency that will not seriously affect the REH's
average length of stay. As a result, we do not anticipate that the REH
would be at risk for exceeding the statutory annual per patient average
length of stay of 24 hours or less.
3. Basic Requirements (Proposed Sec. 485.504)
At Sec. 485.504 we propose to set forth the basic requirements for
REHs in accordance with section 1861(kkk) of the Act. Participating
REHs would be limited to those facilities that meet the definition in
proposed Sec. 485.502 and have in effect a provider agreement as
defined at 42 CFR 489.3. We would add REHs to the list of providers
required to obtain a provider agreement at Sec. 489.2(b) in the
``Conforming Amendments'' section of this proposed rule.
4. Designation and Certification of REHs (Proposed Sec. 485.506)
At Sec. 485.506 we propose to set forth the criteria for CMS
certification of an REH in accordance with section 1861(kkk) of the
Act. We propose to establish that CMS would certify a facility as an
REH if the facility was, as of the date of enactment of the CAA, a CAH,
or a hospital as defined in section 1886(d)(1)(B) of the Act with not
more than 50 beds located in a county (or equivalent unit of local
government) considered rural (as defined in section 1886(d)(2)(D) of
the Act), or treated as being located in a rural area pursuant to
section 1886(d)(8)(E) of the Act. In addition, to be treated as being
located in a rural area for the purpose of REH eligibility, we are
proposing as part of this proposed rule that a hospital located in a
metropolitan county must have had an active reclassification from urban
to rural status as specified in section 42 CFR 412.103 as of December
27, 2020.
5. Compliance With Federal, State, and Local Laws and Regulations
(Proposed Sec. 485.508)
Consistent with the requirements for all Medicare- and Medicaid-
participating providers and suppliers, we propose to require REHs to
comply with Federal, state, and local laws and regulations.
At Sec. 485.508(a) we propose to require the REH to be in
compliance with applicable Federal laws, state, and local laws and
regulations. In accordance with section 1861(kkk)(5) of the Act, we
also propose to require at Sec. 485.508(b) that the REH is located in
a state that provides for the licensing of such hospitals under state
or applicable local law. In addition, under Sec. 485.508(b)(1) and
(2), we propose that the REH be licensed in the state as an REH or be
approved as meeting standards for licensing by the agency in the state
or locality responsible for licensing hospitals. We note that in many
instances, states and localities, have more stringent laws and
regulations than the Federal requirements. In cases in which state law
or regulations are more stringent, the REH would need to comply with
the more stringent state or local requirements to meet the proposed
requirements at Sec. 485.508(a).
At Sec. 485.508(c), we propose to require that the REH ensure that
personnel are licensed or meet other applicable standards required by
state or local laws to provide services within the applicable scope of
practice. Some commenters on the REH RFI recommended that CMS encourage
[[Page 40354]]
licensure portability among health care practitioners. Commenters
indicated that allowing practitioners to practice in multiple states
would greatly support both in-person and virtual care models in rural
areas where the closest health care provider may be across the state
line. This proposed standard does not prohibit a practitioner that is
licensed in a different state than where the REH is located from
providing care at the REH; state laws govern whether this is
permissible.
6. Condition of Participation: Governing Body and Organizational
Structure of the REH (Proposed Sec. 485.510)
To ensure appropriate oversight of the REH, we propose at Sec.
485.510 to require the REH to have an effective governing body, or
responsible individual or individuals, that is legally responsible for
the conduct of the REH. This aligns with the CAH CoP for organizational
structure at Sec. 485.627(a). In addition to oversight, we expect the
responsibilities of the governing body or responsible individual to
include ensuring that the REH is effectively executing its policies and
decision-making about the REH's vision, mission, and strategies. If an
REH does not have an organized governing body, we propose to require
that the person or persons legally responsible for the conduct of the
REH carry out the functions specified in this part that pertain to the
governing body.
Consistent with the hospital governing body CoPs at Sec. 482.12,
we propose at Sec. 485.510(a)(1) to require the governing body, in
accordance with state law, to determine which categories of
practitioners are eligible candidates for appointment to the medical
staff. Additionally, consistent with the interpretive guidelines for
CAHs in Appendix W of the State Operations Manual for the standard for
Governing Body or Responsible Individual at Sec. 485.627(a), we
propose to require that the governing body of the REH appoint members
of the medical staff after considering the recommendations of the
existing members of the medical staff. The role of the medical staff is
the promotion of patient safety and the quality of care. This proposal
would give maximum flexibility to an REH in determining and granting
staff privileges and organizing its medical staff, and it would allow
the REH to grant specific privileges related to patient care to various
other types of licensed practitioners as it needed, in addition to the
privileges it would choose to grant to doctors of medicine or
osteopathy. For example, an REH could choose to grant medical staff
privileges to nurse practitioners and physician assistants if this is
allowable under state law. We also propose to require that the REH's
governing body must ensure that its medical staff is accountable to the
governing body for the quality of patient care provided by the REH;
organizes itself under bylaws; and ensures that the criteria for
selection to the medical staff are individual character, competence,
training, experience, and judgment.
Many rural populations suffer from limited access to care due to a
shortage of health care professionals, especially physicians. Often
times, clinicians other than physicians provide important care services
to rural communities with physicians providing oversight. This may
occur in many different ways, including via the use of mobile health,
video and audio technologies, digital photography and remote patient
monitoring. With the development of technology that facilitates
``telemedicine,'' a physician could utilize a variety of methods to
provide health care services, including being on-site at a facility or
at a distant site furnishing services remotely to a patient located at
an originating site.
Commenters on the REH RFI noted that REHs should be able to be an
originating site (that is, the location where a Medicare patient
receives medical services from a physician or other clinician through a
telecommunications system) for the provision of telehealth services. As
noted in the CY 2022 Medicare Physician Fee Schedule final rule (86 FR
65057), section 125(c) of the CAA amended section 1834(m)(4)(C)(ii) of
the Act to add REHs to the list of permissible telehealth originating
sites. In accordance with section 1834(m)(4)(C)(ii)(XI) of the Act, as
added by section 125(c) of the CAA, we finalized a revision to Sec.
410.78(b)(3) of our regulations to add REH, as defined in section
1861(kkk)(2) of the Act, as a permissible originating site for
telehealth services furnished on or after January 1, 2023.
For the purposes of this rule, similar to our interpretation in the
policy set out in our final rule, ``Medicare and Medicaid Programs;
Changes Affecting Hospital and Critical Access Hospital Conditions of
Participation: Telemedicine Credentialing and Privileging'' (76 FR
25550 through 25556), we see telemedicine as encompassing the overall
delivery of health care to the patient through the practice of patient
assessment, diagnosis, treatment, consultation, transfer and
interpretation of medical data, and patient education all via a
telemedicine link (for example, audio, video, and data
telecommunications as may be utilized by distant-site physicians and
practitioners). Therefore, in order to make clear that the
credentialing and privileging provisions proposed for REHs are not
limited to the narrower subset of services and sites eligible for
Medicare telehealth payment, we chose to use the term,
``telemedicine,'' throughout this rule instead of ``telehealth.'' As
noted previously, payment policies for REHs, including for services
furnished via telehealth/telemedicine, will be addressed in separate
notice and comment rulemaking.
In recognition of the important role that telemedicine can play in
the provision of care in rural communities, we believe it is necessary
to establish a more efficient process for REHs to credential and
privilege clinicians who provide telemedicine services for the REH's
patients. We are proposing requirements similar to the telemedicine
credentialing and privileging process requirements established for
hospitals and CAHs that would allow for an optional and more
streamlined credentialing and privileging process that REHs may use for
practitioners providing telemedicine services for their patients. We
believe that like small hospitals and CAHs seeking to provide enhanced
access to care through the use of telemedicine services for their
patients, REHs might lack the resources to fully carry out the
traditional credentialing and privileging process for all of the
physicians and practitioners that may be available to provide
telemedicine services. In addition to the costs and administrative
staff needed for this process, REHs would also most likely not have in-
house medical staff with the clinical expertise to adequately evaluate
and privilege the wide range of specialty physicians that larger
hospitals can provide their patients through the use of telemedicine
services. Therefore, at Sec. 485.510(a)(8) we are proposing that REH's
governing body ensure that when telemedicine services are furnished to
the REH's patients through an agreement with a Medicare-participating
hospital (the ``distant-site''--the site at which the physician or
practitioner is located at the time the service is provided via a
communications system, as defined at section 1834(m)(4)(A) of the Act),
the agreement must specify that it is the responsibility of the
governing body of the distant-site hospital providing the telemedicine
services to meet the requirements in Sec. 485.510(a)(1) through (7)
with regard to its physicians and practitioners who are providing
telemedicine services. These provisions
[[Page 40355]]
cover the distant-site hospital's governing body responsibilities for
its medical staff that all Medicare-participating hospitals must
currently meet and that REHs would be required to meet when this rule
is finalized. The proposed requirements at Sec. 485.510(a)(8) would
allow the governing body of the REH whose patients are receiving the
telemedicine services to grant privileges based on the recommendations
of its medical staff, who would rely on information provided by the
distant-site hospital, as a more efficient means of privileging the
individual distant-site physicians and practitioners. This provision
would be accompanied by the proposed requirement in the ``Medical
staff'' CoP at Sec. 485.510(a), which would provide the basis on which
the REH's governing body, through its agreement as noted above, can
choose to have its medical staff rely upon information furnished by the
distant-site hospital when making recommendations on privileges for the
individual physicians and practitioners providing such services. This
option would not prohibit an REH's medical staff from continuing to
perform its own periodic appraisals of telemedicine members of its
staff, nor would it bar them from continuing to use the proposed
traditional credentialing and privileging process proposed at Sec.
485.512(a)(2). The intent of this proposed requirement is to relieve
burden for REHs by providing for a less duplicative and more efficient
privileging scheme with regard to physicians and practitioners
providing telemedicine services. However, in an effort to ensure
accountability to the process, we are proposing within this same
provision (Sec. 485.512(a)(3)) that the REH, in order to choose this
less burdensome option for privileging, must ensure that (1) the
distant-site hospital providing the telemedicine services is a
Medicare-participating hospital; (2) the individual distant-site
physician or practitioner is privileged at the distant-site hospital
providing telemedicine services, and that this distant-site hospital
provides a current list of the physician's or practitioner's
privileges; (3) the individual distant-site physician or practitioner
holds a license issued or recognized by the state in which the REH,
whose patients are receiving the telemedicine services, is located; and
(4) with respect to a distant-site physician or practitioner granted
privileges by the REH, the REH has evidence of an internal review of
the distant-site physician's or practitioner's performance of these
privileges and sends the distant-site hospital this information for use
in its periodic appraisal of the individual distant-site physician or
practitioner. We are also proposing, at a minimum, the information sent
for use in the periodic appraisal would have to include all adverse
events that may result from telemedicine services provided by the
distant-site physician or practitioner to the REH's patients and all
complaints the REH has received about the distant-site physician or
practitioner. We are also proposing at Sec. 485.512(c)(5) to require
that REH's medical staff bylaws include criteria for determining
privileges and a procedure for applying the criteria to individuals
requesting privileges. We are proposing to add language to stipulate
that in cases where distant-site physicians and practitioners are
requesting privileges to furnish telemedicine services through an
agreement with an REH, the criteria for determining those privileges
and the procedure for applying the criteria would be subject to the
proposed requirements at Sec. Sec. 485.510(a)(8) and (9) and
485.512(a)(3) and (4).
Similar to the revisions we made in the ``Changes Affecting
Hospital and Critical Access Hospital Conditions of Participation''
final rule (76 FR 25556), we have also concluded that it is important
that the medical staff of a distant-site telemedicine entity, which may
not be a Medicare-participating hospital, be included in an optional
and streamlined credentialing and privileging process for those REHs
electing to enter into agreements for telemedicine services with such
entities. However, similar to the situation we faced for hospitals and
CAHs in the May 2011 final rule (that is, the inclusion of distant-site
telemedicine entities into this streamlined process without CMS having
any regulatory or oversight authority over these entities), we realized
that the proposed requirements for REHs would need to hold distant-site
telemedicine entities accountable to the originating-site REH for
meeting CMS practitioner credentialing and privileging standards. And
like the current requirements for hospitals and CAHs using telemedicine
services, REHs would need to provide, upon request when surveyed, the
most current telemedicine services agreement showing that the distant-
site entities providing the services are required to comply with the
CMS standards (even though CMS has no direct authority over those
entities) in order for the REH to make use of the more streamlined
process when credentialing and privileging practitioners from these
distant-site telemedicine entities. Similar to our regulations proposed
for REHs using the telemedicine services of distant-site Medicare-
participating hospitals, the written agreement between the REH and the
distant-site telemedicine entity would be the foundation for ensuring
accountability on both sides. However, due to the differences already
discussed between Medicare-participating distant-site hospitals
providing telemedicine services and distant-site practitioners under
section 1834(m) of the Act providing similar services, there must also
be differences in the way the regulations are written.
Therefore, we are also proposing requirements that would apply to
the credentialing and privileging process and the agreements between
REHs and distant-site telemedicine entities (Sec. Sec. 485.510(a)(9)
and 485.512(a)(4)). These provisions would require the governing body
of the REH (or responsible individual), through its written agreement
with the distant-site telemedicine entity, to ensure that the distant-
site telemedicine entity, acting as a contractor of services, furnishes
its services in a manner that enables the REH to comply with all
applicable CoPs and standards. For the contracted services, the
applicable CoPs and standards would include, but are not limited to,
the credentialing and privileging requirements for distant-site
physicians and practitioners furnishing telemedicine services.
7. Condition of Participation: Provision of Services (Proposed Sec.
485.514)
Several commenters on the REH RFI indicated that CMS should remain
flexible in the development of the standards for REHs and that the
standards should closely mirror the CAH requirements, where
appropriate. Consistent with the CAH CoPs at Sec. 485.635(a)(1), we
propose at Sec. 485.514(a) to require that the REH's health care
services must be furnished in accordance with appropriate written
policies that are consistent with applicable state law and at Sec.
485.514(b) that the REH must have policies that are developed with the
advice of members of the REH's professional health care staff,
including one or more doctors of medicine or osteopathy and one or more
physician assistants, nurse practitioners, or clinical nurse
specialists, if they are on staff. This requirement aligns with the CAH
CoPs at Sec. 485.635(a)(2).
At Sec. 485.514(c) we propose requirements for the written
policies to include a description of the services the REH furnishes
(including those furnished through agreement or arrangement), policies
and procedures
[[Page 40356]]
for emergency medical services, guidelines for the medical management
of health problems, and policies and procedures that address the post-
acute care needs of all patients receiving services furnished by an
REH. Because the statute prohibits REHs from the provision of inpatient
services (with the exception of patients receiving SNF services in a
distinct part SNF), post-acute care for an REH patient is any care the
REH patient receives once they are discharged from the REH. Lastly, at
Sec. 485.514(d), we propose to require the policies to be reviewed at
least biennially by the group of professional personnel required at
Sec. 485.514(b) and updated as necessary by the REH. These
requirements align with the CAH CoPs at Sec. 485.635(a)(3).
8. Condition of Participation: Emergency Services (Proposed Sec.
485.516)
In accordance with section 1861(kkk)(2)(D)(iv) of the Act, as added
by section 125(a)(1)(B) of the CAA, REHs must comply with the CAH
emergency services requirements at Sec. 485.618 as well as the
hospital emergency services requirements, which are located at Sec.
482.55, as determined to be applicable. We note that at Sec. 482.12(f)
if emergency services are not provided at the hospital, the governing
body must assure that the medical staff has written policies and
procedures for appraisal of emergencies, initial treatment, and
referral when appropriate. Conversely, CAHs are required by the CoPs to
provide emergency services, resulting in different emergency services
requirements for each of these provider types. However, one similarity
in the hospital and CAH emergency services requirements is that CAHs
and hospitals (should they choose to provide emergency services) are
required to have emergency services that meet the needs of their
respective patients presenting at the individual facility. We believe
that it is important that the REH emergency services also meet the
needs of its patients. As such, at Sec. 485.516 we propose to require
that the REH must provide the emergency care necessary to meet the
needs of its patients in accordance with acceptable standards of
practice.
Additionally, because the primary function of an REH is to provide
emergency services, similar to the requirements for hospitals, we
propose at Sec. 485.516(a) that the REH must have emergency services
that are organized under the direction of a qualified member of the
medical staff and are integrated with other departments of the REH. We
anticipate that there will be instances in which a patient is receiving
outpatient services other than emergency services and may unexpectedly
require care in the emergency department. In this instance, having
emergency services that are integrated with the other departments of
the REH will facilitate care coordination and promote patient-centered
care.
At Sec. 485.516(b), we propose that there be adequate medical and
nursing personnel qualified in emergency care to meet the needs of the
facility. To comply with this requirement, we would expect the REH to
conduct an analysis based on the anticipated staffing needs and once
the REH begins to provide services, the analysis would include actual
staffing needs. Lastly, at Sec. 485.516(c), we propose to require the
REH to provide emergency services that meet the CAH requirements
specified at Sec. 485.618(a) through (e), as required by section
1861(kkk)(2)(D)(iv)(I) of the Act. We are seeking comment on the
proposed staffing requirements for the provision of emergency services
in an REH to gain insight on the appropriateness of not requiring a
practitioner to be on-site at the REH at all times.
9. Condition of Participation: Laboratory Services (Proposed Sec.
485.518)
We believe that like hospitals, REHs should provide laboratory
services that are determined to be appropriate and necessary based on
the level of services provided at the REH. This portion of the
provision aligns with the hospital CoP at Sec. 482.27. Efficient
laboratory support is a crucial to providing quality emergency
services, especially given the continued rise in emergency department
visits. Efficient laboratory support positively impacts emergency
services by contributing to the assessments used to determine diagnosis
and treatment and whether a patient should be discharged home or
transferred to a higher level of care. Emergency departments generally
provide laboratory services by utilizing point of care testing, a
laboratory technician based in the emergency department, or an
emergency department stat (``Statim'', Latin for ``immediately'')
laboratory either directly or through a contractual agreement with a
laboratory. Overall, the ability to provide quality laboratory services
in the emergency department decreases the overall length of stay for
patients, therefore we are proposing at Sec. 485.518 that REHs,
similar to CAHs (Sec. 485.635(b)(2)), must provide basic laboratory
services that are essential to the immediate diagnosis and treatment of
the patient. The CAH requirements cite specific laboratory services
that should be provided by the CAH, such as chemical examination of
urine, hemoglobin or hematocrit, blood glucose, examination of stool
specimens for occult blood, pregnancy tests, and primary culturing for
transmittal to a certified laboratory. However, we believe that given
the REH's nature of primarily providing emergency services, it is
appropriate that REHs provide laboratory services that are consistent
with nationally recognized standards of care for emergency services. In
addition to the laboratory services identified in the CAH CoPs, we
encourage the REH to provide laboratory services that include a
complete blood count, basic metabolic panel (also known as a ``chem
7''), magnesium, phosphorus, liver function tests, amylase, lipase,
cardiopulmonary tests (troponin, brain natriuretic peptide, and d-
dimer), lactate, coagulation studies (prothrombin time, partial
thromboplastin time, and international normalized ratio), arterial
blood gas, venous blood gas, quantitative human chorionic gonadotropin,
and urine toxicology. In accordance with the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), at Sec. 485.518(a), we are
proposing to require that the REH must ensure that all laboratory
services provided to its patients are performed in a facility certified
in accordance with the CLIA requirements at 42 CFR part 493.
Furthermore, at Sec. 485.518(b) we are also proposing that REHs must
have emergency laboratory services available that would be essential to
the immediate diagnosis of the patient, 24 hours a day. This proposal
is appropriate given the provision that REHs must provide emergency
services 24 hours a day. In addition, this proposal is consistent with
comments received on the REH RFI noting that laboratory services should
be required for REHs.
10. Condition of Participation: Radiologic Services (Proposed Sec.
485.520)
Radiologic services play an integral role in the provision of
emergency services. Commenters on the REH RFI noted that radiologic
services, also referred to as imaging services, should be provided at
REHs. A study in the American Journal of Roentgenology noted that,
``The use of imaging in the emergency department (ED) has increased
over time, and by 2010 nearly half of all ED visits in the U.S.
included at least one imaging test.'' \9\ These
[[Page 40357]]
imaging tests include computed tomography (CT), also known as a
computerized axial tomography (CAT) scan, magnetic resonance imaging
(MRI), and ultrasound. These tests can be used to diagnose bone
fractures, infections, arthritis, injuries from trauma, tumors and
cancers. They can also be used to monitor and evaluate the growth and
development of a fetus, and offer a way to examine many of the body's
internal organs such as the liver, gallbladder, kidneys, and bladder.
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\9\ Ali S. Raja, Ivan K. Ip, Aaron D. Sodickson, Ron M. Walls,
Steven E. Seltzer, Joshua M. Kosowsky, and Ramin Khorasani (2014).
American Journal of Roentgenology, (203)2, 355-360. https://doi.org/10.2214/AJR.13.11892.
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We expect that REHs will need to provide radiologic services given
their focus on emergency services and given the number of emergency
department patients who receive imaging services. Therefore, we propose
that the REH radiologic requirements mirror the hospital radiologic
requirements found at Sec. 482.26, which is consistent with the
current CAH standard at Sec. 485.635(b)(3) and interpretative
guidelines for CAHs in Appendix W of the State Operations Manual (SOM).
The CAH standard for radiology services found at Sec.
485.635(b)(3) requires and that these services are furnished by
personnel qualified under state law and do not expose patients or staff
to radiation hazards. In addition, we note that the interpretative
guidelines for Sec. 485.635(b)(3) in Appendix W of the SOM provides
guidance for designating qualified radiologic personnel, developing
policies and procedures that ensure safety from radiation hazards,
inspecting and maintaining radiologic equipment, and maintaining CAH
radiology records.
We are proposing to align the REH requirements with the hospital
requirements for radiologic services and propose additional standards
related to safety, personnel responsibilities, and record keeping. We
believe that facilities that may transition to an REH would presently
be performing these activities to support the delivery of radiology
services. We also believe that these proposed requirements are in
accordance with the interpretative guidelines that CAHs currently
follow for the provision radiological services. We do not expect these
proposed requirements to create additional burden for REHs over those
applicable to CAHs.
As such, at Sec. 485.520, we propose to require that the REH must
provide diagnostic radiologic services. We propose to require that all
radiologic services furnished by the REH must be provided by qualified
personnel in accordance with state law and do not expose REH patients
or personnel to radiation hazards at Sec. 485.520(a). Like hospitals,
we are also proposing to require that the REH must have radiologic
services that meet the needs of their patients. For example, we expect
an REH that is located in a mining community to offer x-ray services
due to the effects of mining on one's lungs or an REH being able to
furnish ultrasounds to evaluate the growth and health of a fetus.
At Sec. 485.520(b), we are proposing basic factors relating to
safety hazard standards for patients and personnel by specifying that
the REH must institute proper safety precautions, perform periodic
inspections of equipment, periodically check radiation workers for
exposure, and only provide radiologic services based on the order of
practitioners with clinical privileges or authorization by the medical
staff and governing body. We propose the personnel standard at Sec.
485.520(c) to require that a qualified radiologist, or other personnel
qualified under state law either full-time, part-time, or on a
consulting basis interpret radiologic tests that require specialized
knowledge. This requirement can be fulfilled through arrangements with
off-site providers via telehealth. Like hospitals, we propose that the
radiologist in an REH must sign reports only of their interpretations.
We propose to allow the medical staff and the individual responsible
for radiological services to designate who is qualified to use
radiological equipment. Lastly, at Sec. 485.520(d), we also propose to
require that records of departmental activities be maintained and that
radiological reports and films be preserved for 5 years, consistent
with the proposed requirements for the maintenance and retention of the
REH medical records.
11. Condition of Participation: Pharmaceutical Services (Proposed Sec.
485.522)
Pharmaceutical services are another integral part of the provision
of health care services in an emergency department. The Journal of
Medical Toxicology cited in a 2018 article that, ``Clinical pharmacists
are integral to the care and safety of patients in the hospital,
particularly in specialty and high-risk settings. Emergency departments
(EDs) represent care environments that carry unique risks.'' \10\ The
article continues to note, ``Adult and pediatric patients present with
undifferentiated medical, neurological, traumatic, psychiatric, and
surgical complaints 24 [hours] a day, 7 days a week. Patients are
generally unfamiliar to the emergency care providers, may be unable to
communicate relevant medical information, and may require time-
sensitive interventions. When present, ED crowding is associated with
increased risk for medication errors.'' \10\ Given these identified
risks, we believe that the REH should have standards for pharmaceutical
services.
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\10\ Farmer, B.M., Hayes, B.D., Rao, R., Farrell, N., & Nelson,
L. (2018). The Role of Clinical Pharmacists in the Emergency
Department. Journal of medical toxicology: official journal of the
American College of Medical Toxicology, 14(1), 114-116. https://doi.org/10.1007/s13181-017-0634-4.
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While the current CAH requirements do not have a separate CoP for
pharmaceutical services, there are standards throughout the CAH CoPs
for the oversight, storage, and administration of drugs and
biologicals. Regulations at Sec. 485.623(b)(3) requires the CAH to
store drugs and biologicals properly, and Sec. 485.635(a)(3)(iv)
requires the CAH to develop rules for the storage, handling,
dispensation, and administration of drugs and biologicals including a
drug storage area administered in accordance with accepted principles.
In addition, there are standards throughout the CAH CoPs regarding
provisions for infection prevention and control and antibiotic
stewardship programs that reference pharmacy leadership and pharmacy
services. Therefore, we believe that providers that may transition to
an REH would currently be performing the proposed REH requirements to
support the delivery of pharmaceutical services; we do not expect these
proposed requirements to create additional burden for REHs.
We are proposing to require that the REH's pharmaceutical services
meet the needs of the patients at proposed Sec. 485.522. According to
the American Society of Health-System Pharmacists Guidelines on
Emergency Medicine Pharmacy Services, some factors that an ED is
expected to consider when determining how the pharmaceutical services
can best meet the needs of the patients include the type and setting of
the ED (for example, academic, community, urban, or rural), the size of
the ED, the number of annual visits, the patient population served, and
any specialty services available.\11\ At Sec. 485.522(a), we propose
to require the REH to have a pharmacy or drug storage
[[Page 40358]]
area that is administered in accordance with accepted professional
principles and in accordance with state and Federal laws. Additionally,
we propose to require at Sec. 485.522(a)(1) that a registered
pharmacist or other qualified individual in accordance with state scope
of practice laws direct the pharmaceutical services or, when
appropriate, have a drug storage area that is supervised by an
individual who is competent to do so. Rural communities are often
challenged by the lack of pharmacists willing to move to rural areas
and for this reason, we recognize that there may be REHs that can
provide pharmaceutical services only by having a drug storage area that
is under the supervision of a qualified individual. In these instances,
the facility must establish qualifications for the individual with
oversight of the drug storage area for competency purposes and ensure
that someone is fulfilling the role who meets those requirements. This
is consistent with the interpretive guidelines for the CAH CoPs
contained in Appendix W of the SOM for Sec. 485.635(a)(3). We are
proposing that this individual be available for a sufficient time to
provide such oversight based on the scope and complexity of the
services offered at the REH. This individual would not be required to
be a full-time pharmacist. We believe sufficient time provides the REH
with the flexibility to determine how frequently the pharmacist or
other qualified individual is available.
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\11\ American Society of Health-System Pharmacists (2021). ASHP
guidelines on emergency medicine pharmacist services. Am J Health-
Syst Pharm, 78(3):261-275. https://doi.org/10.1093/ajhp/zxaa378.
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Furthermore, the CAH interpretive guidelines for Sec.
485.635(a)(3) states that the compounding, packaging, and dispensing of
drugs be consistent with accepted professional principles. In
accordance with the Food and Drug Administration, accepted professional
principles for compounding, packaging, and dispensing of drugs include
having a licensed pharmacist, or in some cases a physician, perform
these activities (or having them performed under the supervision of a
licensed pharmacist, when appropriate). As such, we propose at Sec.
485.522(b) that all compounding, packaging, and dispensing of drugs
must be done by a licensed pharmacist or a licensed physician, or under
the supervision of a pharmacist or other qualified individual in
accordance with state scope of practice laws and be performed
consistent with state and Federal laws. In addition, we propose that
all drugs and biologicals must be kept in secure areas, and locked when
appropriate. All drugs listed in Schedules II, III, IV, and V as
outlined in the Comprehensive Drug Abuse Prevention and Control Act of
1970 (Pub. L. 91-513, as amended), must be locked within a secure area
and only authorized personnel may have access to locked areas. We
propose that outdated, mislabeled, or otherwise unusable drugs and
biologicals must not be available for patient use and drugs and
biologicals can only be removed from the pharmacy or storage area by
personnel designated in the policies of the medical staff and
pharmaceutical service, in accordance with Federal and state law. These
proposed requirements are also consistent with the CAH interpretive
guidelines for Sec. 485.635(a)(3).
Lastly, at Sec. 485.522(c) we propose to set forth the standards
for the administration of drugs. We note that the existing CAH CoP at
Sec. 485.635(a)(3)(iv) requires that the CAH have written policies
that include the rules for the storage, handling, dispensation, and
administration of drugs and biologicals. The CAH CoPs continue to
require that these rules provide that there is a drug storage area that
is administrated in accordance with accepted professional principles.
Similarly, we propose to require that drugs be prepared and
administered in an REH according to established policies and acceptable
standards of practice and consistent with the CAH requirement at Sec.
485.635(a)(3)(v), we propose to require that any adverse reactions be
reported to the physician responsible for the patient and documented in
the record. While the CAH CoPs require that the CAH have procedures for
reporting adverse drug reactions and errors in the administration of
drugs, we recognize that a nationally recognized standard of practice
is to report adverse drug reactions to the physician responsible for
the care of the patient. We propose at Sec. 485.522(c)(2) and (3)
respectively, that the REH must administer blood transfusions, blood
products and intravenous medications in accordance with state law and
approved medical staff policies and procedures, and that orders given
orally for drugs and biologicals must be followed by a written order,
signed by the prescribing physician or other authorized prescriber. We
also propose at Sec. 485.522(c)(4) to require that the REH have a
procedure for reporting transfusion reactions, adverse drug reactions,
and errors in administration of drugs.
12. Condition of Participation: Additional Outpatient Medical and
Health Services (Proposed Sec. 485.524)
In addition to the provision of emergency services and observation
care, section 1861(kkk)(1)(A)(ii) of the Act allows REHs to provide
additional outpatient medical and health services as specified by the
Secretary through rulemaking. We received comments on the REH RFI
recommending that CMS allow REHs to provide additional outpatient
services that include radiology, laboratory, outpatient rehabilitation,
surgical, maternal health, and behavioral health services. We are
proposing at Sec. 485.524 that REHs be allowed to provide additional
medical and health outpatient services that include, but are not
limited, to those identified by commenters. We note that the REH may
provide additional outpatient medical and health care services beyond
those specified; however, we expect that the REH would be able to
demonstrate that the service is needed based on an assessment of its
community as required by proposed Sec. 485.524(a). The decision should
be based on a health needs assessment that is achieved by taking a
systematic approach to ensuring that the services furnished by an REH
are appropriate and meet the needs of the community.
Commenters on the REH RFI highlighted that providing rehabilitation
services to rural communities requires overcoming the challenges of the
landscape, limited referral options, and a shortage of therapists.
In addition, one of the health care needs in many rural communities
is improving access to maternal health care services. As noted in CMS'
Issue Brief Improving Access to Maternal Health Care in Rural
Communities: \12\
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\12\ Centers for Medicare and Medicaid Services (2019).
Improving Access to Maternal Health Care in Rural Communities--Issue
Brief. https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/rural-health/09032019-Maternal-Health-Care-in-Rural-Communities.pdf.
A lack of access to high quality maternal health services in
rural communities is the result of many factors including hospital
and obstetric department closures, workforce shortages, and access
to care challenges arising from the social determinants of health
which have contributed to disparities in maternal health care for
rural women and their babies. These access challenges can result in
a number of negative maternal health outcomes including premature
birth, low-birth weight, maternal mortality, severe maternal
morbidity, and increased risk of postpartum depression. These health
disparities affect American Indian and Alaska Native and women of
color disproportionately. Since one in five Americans live in a
rural community, including approximately 18 million women of
reproductive age, it is critical that federal, regional, state,
local agencies and communities work together to improve access to
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high quality maternal health services in rural communities.
[[Page 40359]]
The issue brief, which was published in 2019, highlights the role
hospitals closures have played in the access issues to maternal health
services in rural communities, noting that between 2004 and 2014, 179
rural counties lost or closed their hospitals obstetric services,
contributing to the fact that fewer than 50 percent of rural women have
access to perinatal services within a 30-mile radius.\12\
Additionally, the Biden-Harris Administration has made it their
highest priority to improve access to maternal health care services.
The Administration published a fact sheet on April 13, 2022, announcing
actions to be taken to address the maternal health crisis in the United
States (Fact Sheet: Biden-Harris Administration Announces Additional
Actions in Response to Vice President Harris's Call to Action on
Maternal Health, https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/13/fact-sheet-biden-harris-administration-announces-additional-actions-in-response-to-vice-president-harriss-call-to-action-on-maternal-health/). These actions include:
Calling on states to expand their postpartum Medicaid and
Children's Health Insurance Program coverage;
Proposing the ``Birthing-Friendly'' hospital designation
to drive improvements in maternal health outcomes and maternal health
equity;
Engaging the health care industry to improve health
outcomes;
Strengthening Maternal, Infant, and Early Childhood Home
Visiting (MIECHV) Programs;
New funding for the State Maternal Health Innovation and
Implementation (State MHI) Program;
Publication of a new Maternal Health Best Practice Guide
for providers to incorporate telehealth for prenatal and postpartum
care, and monitoring within high-risk pregnancy;
Investing in doulas;
Restoring access to Title X family planning services
nationwide to fill service gaps caused by the withdrawal of Title X
providers from the program; and
Including in the proposed FY 2023 budget a proposed $470
million to be used to reduce maternal mortality and morbidity rates;
expand maternal health initiatives in rural communities; implement
implicit bias training for healthcare providers; create pregnancy
medical home demonstration projects; and address the highest rates of
perinatal health disparities, including by supporting the perinatal
health workforce.
Given the highlighted challenges faced by those living in rural
communities of accessing maternal health services and consistent with
the Administration's priorities in improving access to these services,
we believe it would be beneficial that REHs provide maternal health
services that include prenatal care, low-risk labor and delivery and
postnatal care. We are seeking input on the issue of whether REHs
should be permitted to provide low-risk labor and delivery, and whether
or not we should require that the REH also provide outpatient surgical
services in the event surgical labor and delivery intervention is
necessary. REHs should base their determination on what is considered a
``low-risk'' delivery on nationally recognized standards and
guidelines. If a laboring patient presents to the REH for labor and
delivery services and subsequently requires emergency surgical
intervention, the REH would be responsible for providing the emergency
and stabilizing treatment prior to transfer, including any emergency
surgical procedures including but not limited to c-sections. Once the
patient is stabilized, they may be transferred to an appropriate level
of care for mother and baby given that the average length of inpatient
stay for an uncomplicated c-section is 2.7 days.\13\ In such cases, we
would encourage the REH to provide the patient's follow-up and
postpartum care so long as the patient's needs are within the scope of
practice of the practitioners providing services at the REH. We would
expect that the REH would leverage clinicians other than only
physicians so that a variety of trained professionals or support
persons could help to address barriers to access to care and the
maternal health workforce shortage in rural areas by utilizing nurse
practitioners, nurse midwives, and doulas as allowed by state law.
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\13\ Federspiel, J.J., Suresh, S.C., Darwin, K.C., & Szymanski,
L.M. (2020). Hospitalization Duration Following Uncomplicated
Cesarean Delivery: Predictors, Facility Variation, and Outcomes. AJP
reports, 10(2), e187-e197. https://doi.org/10.1055/s-0040-1709681.
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The provision of behavioral health services is also a challenge in
rural communities. According to the Rural Health Information Hub, ``. .
. approximately 7.7 million nonmetropolitan adults reported having any
mental illness (AMI) in 2020, accounting for 20.5% of nonmetropolitan
adults. In addition, 1.8 million, or 4.8%, of adults in nonmetropolitan
areas reported having serious thoughts of suicide during the year.''
\14\ The Rural Health Information Hub also presents specific challenges
in this area, including the following: \15\
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\14\ Rural Health Information Hub (2021). Rural Mental Health.
https://www.ruralhealthinfo.org/topics/mental-health.
\15\ Center for Disease Control and Prevention (2017). Rural
Health--Drug Overdose. https://www.cdc.gov/ruralhealth/drug-overdose/.
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Accessibility--Rural residents often travel long distances
to receive services, are less likely to be insured for mental health
services, and providers are less likely to recognize a mental illness.
Availability--Chronic shortages of mental health
professionals exist and mental health providers are more likely to
practice in urban centers.
Affordability--Some rural residents may not be able to
afford the cost of health insurance or the cost of out-of-pocket care
if they lack health insurance.
Acceptability--Rural residents may be more susceptible to
the stigma of needing or receiving mental health care in small
communities where everyone knows each other and fewer choices of
trained professionals can lead to a lack of faith in confidentiality,
as well as a reliance on the informal care of family members, close
friends, and religious leaders.
Several commenters on the REH RFI indicated that REHs should
provide behavioral health services that include substance use disorder
treatment. According to the Centers for Disease Control and Prevention,
``Rates of drug overdose deaths are rising in rural areas, surpassing
rates in urban areas.'' \15\ Additionally, treatment for alcohol and
illicit drug use was generally the same or higher in nonmetropolitan
counties compared to metropolitan counties, according to data from the
2018 National Survey on Drug Use and Health (Substance Abuse and Mental
Health Services Administration, https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2018R2/NSDUHDetTabsSect5pe2018.htm#tab5-9a). The survey highlighted substance
use disorders related to alcohol, methamphetamines, and opioids,
particularly noting that rural counties exhibited a higher rate of
opioid overdoses than urban counties and that opioid misuse is high in
states with large rural populations. There are several factors that
contribute to substance use disorder in rural communities, including
high rates of poverty and unemployment, increased availability of
prescription opioids, and barriers to treatment. These barriers include
the level of complexity related to treatment of substance use
disorders, which includes individual and group counseling, inpatient
and outpatient treatment, case management, and
[[Page 40360]]
medication, as well as additional services and programs. Difficulties
associated with navigating these treatment modalities may, and often
does lead to delays in treatment. This adds to existing access to care
issues in rural communities where there are shortages of providers,
ultimately resulting in delays in treatment. This further illustrates
the need for behavioral health services in rural areas, given the
access to care issues which are more prevalent in rural areas when
compared to non-rural areas. Additionally, given the data provided
related to substance use in rural communities, we would expect that
some REHs may be interested in being opioid treatment providers. We
note that providing these services is not prohibited by the statute at
1866(kkk) so long as the treatment remains an outpatient service, given
that the statute does prohibit REHs from providing inpatient services
(except those services provided in a distinct part SNF of the REH).
If the REH chooses to provide additional outpatient medical and
health services, we propose at Sec. 485.524(a)(1) to require that the
provision of the additional service be based on nationally recognized
guidelines and standards of practice, aligning the proposed requirement
with the hospital CoPs for outpatient services at Sec. 482.54. Given
that the REH does not provide inpatient services, patients requiring a
higher level of care would be required to be transferred to an acute
care hospital or CAH. As a result of this, and based on comments
received on the REH RFI, we further propose to require that the REH
have a system in place for referral from the REH to different levels of
care, including follow-up care, as appropriate. Some of the REH RFI
comments also indicated that REHs should be required to have
established relationships with hospitals that have the resources and
capacity available to deliver care that is beyond the scope of care
delivered at the REH. Hospital admissions and transfers account for
roughly 20 percent of all patient dispositions from the emergency
department across the U.S.\16\ As a result, we can expect that REHs
will transfer at least 20 percent of their patients so we agree with
commenters and are therefore proposing to require that REHs have
established relationships with hospitals that have the resources and
capacity available to deliver care that is beyond the scope of care
delivered at the REH.
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\16\ American College of Emergency Physicians--ACEP Now (2019).
Latest Data Reveal the ED's Role as Hospital Admission Gatekeeper.
https://www.acepnow.com/article/latest-data-reveal-the-eds-role-as-hospital-admission-gatekeeper/.
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Ensuring effective communication between providers of health care
services and patients and their family is a critical element in the
provision of care and the discharge or transfer of patients. We are
proposing to require that the REH have effective communication systems
in place between the REH and patients (or responsible individuals) and
their family, ensuring that the REH is responsive to their needs and
preferences. We believe this would assist with effective care
coordination as well as improved patient outcomes.
At Sec. 485.524(b), we propose personnel requirements for REHs who
choose to provide additional outpatient medical and health services.
These requirements ensure that the additional services provided by the
REH are overseen by at least one responsible individual, have
appropriate professional and nonprofessional personnel available at
each location where outpatient services are offered, and are provided
by a physician or other clinician with experience and training in the
specialty service area.
At Sec. 485.524(c) we propose to specify standards that REHs must
have for ordering outpatient medical and health services that are
consistent with the hospital requirements at 42 CFR 482.54(c).
Specifically, we propose to require outpatient medical and health
services to only be ordered by a practitioner who: (1) is responsible
for the care of the patient; (2) is licensed in the state where they
provide care to the patient; (3) is acting within their scope of
practice under state law; and (4) is authorized in accordance with
state law and policies adopted by the medical staff, and approved by
the governing body, to order the applicable outpatient services. We
also propose that these requirements would apply to those practitioners
who are appointed to the REH's medical staff and who have been granted
privileges to order the applicable outpatient services; and those
practitioners not appointed to the medical staff, but who satisfy the
above criteria for authorization by the REH for ordering the applicable
outpatient services and for referring patients for such services.
Lastly, the importance of allowing REHs to provide outpatient
surgical services was especially noted by commenters in response to the
REH RFI. A 2011 rural policy brief by the Rural Policy Research
Institute (RUPRI) Center for Rural Health Policy Analysis states that,
``Like residents of any community, rural residents have surgical needs
that range from the predictable (e.g., cataract procedures) to the
emergent (e.g., appendectomy). Innovations in surgery over the past
several decades have made possible the provision of many surgical
procedures on an outpatient basis, reducing inpatient admissions.''
\17\ The policy brief found that across four states (Colorado, North
Carolina, Vermont, and Wisconsin) in 2011, surgeries were performed
across 107 CAHs with an average of 522 outpatient procedures performed
per year. This is 75 to 80 percent of the total surgical procedure
volume in the state for that year and demonstrates that there will be a
need for outpatient surgical services in communities in which CAHs
convert to an REH. Therefore, we propose at Sec. 485.524(d) to set
forth standards for an REH performing outpatient surgical services that
are consistent with the CAH requirements for surgical services at Sec.
485.639. These include proposed standards for ensuring that the
services are conducted in a safe manner by qualified practitioners with
specific protocols for administering anesthesia.
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\17\ Rural Policy Research Initiative Rural Health Center for
Rural Health Policy Analysis--Rural Policy Brief (2011). Surgical
Services in Critical Access Hospitals, 2011. https://rupri.public-health.uiowa.edu/publications/policybriefs/2015/Surgical%20Services%20in%20CAHs.pdf.
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Given that in accordance with the statutory provision at
section1861(kkk)(1)(A) of the Act services furnished by the REH must
not exceed an annual per patient average of 24 hours in the REH, we
expect REHs, like ASCs, to provide surgical services to patients not
requiring hospitalization and in which the expected duration of
services would not exceed 24 hours following an admission.
13. Condition of Participation: Infection Prevention and Control and
Antibiotic Stewardship Programs (Proposed Sec. 485.526)
The Department of Health and Human Services (HHS) is particularly
concerned about health care associated infections (HAIs), as they are a
significant cause of morbidity and mortality in the U.S. In 2015, there
were an estimated 687,000 cases of HAIs in U.S hospitals with 72,000
inpatients with HAIs that died during that same time period.\18\
Additionally, HHS is concerned about the growing threat to patient
safety posed by organisms that are resistant to antibiotics, referred
to as ``multi-drug resistant organisms (MDROs).'' Options for treating
patients
[[Page 40361]]
with MDRO infections are very limited, resulting in increased
mortality, as well as increased hospital lengths of stay and costs. In
response, HHS launched an Action Plan in April 2009 with updates in
2013 and 2018 toward the prevention and elimination of HAIs. (HHS.
``HHS Action Plan to Prevent Healthcare-Associated Infections.''
Accessed 5 March 2014 https://www.hhs.gov/ash/initiatives/hai/actionplan/index.html.) The HHS Action Plan identifies policy changes,
some addressed here in this proposed rule, in an effort to provide
better, more efficient care.
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\18\ Centers for Disease Control and Prevention (2020). Data
Portal. https://www.cdc.gov/hai/data/portal/index.html.
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We are proposing a CoP for infection prevention and control and
antibiotic stewardship programs for REHs at Sec. 482.526 in an effort
to mirror similar infection prevention and control requirements for
hospitals and CAHs (at Sec. Sec. 482.42 and 485.640, respectively)
that reflect state-of-the-art practices and terminology. We are also
proposing a standard that would require an REH to develop and maintain
an antibiotic stewardship program as an effective means to improve REH
antibiotic-prescribing practices and curb patient risk for possibly
deadly Clostridium difficile infections (CDIs), as well as other
future, and potentially life-threatening, antibiotic-resistant
infections. We would promote better alignment of an REH's infection
control and antibiotic stewardship efforts with nationally recognized
guidelines and emphasize the role and accountability of an REH's
governing body in program implementation and oversight. We believe that
these requirements, together, would promote a more patient-centered
culture of safety focused on infection prevention and control as well
as appropriate antibiotic use (consistent with the requirements for
hospitals and CAHs), while allowing REHs the flexibility to align their
programs with the guidelines best suited to them.
Therefore, similar to the requirements that we finalized with
regard to infection prevention and control and antibiotic stewardship
programs for hospitals and CAHs in the September 30, 2019 final rule
``Medicare and Medicaid Programs; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction; Fire Safety
Requirements for Certain Dialysis Facilities; Hospital and Critical
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and
Improvement in Patient Care'' (84 FR 51732), we are proposing in this
rule that each REH has facility-wide infection prevention and control
and antibiotic stewardship programs that are coordinated with the REH
quality assessment and performance improvement (QAPI) program, for the
surveillance, prevention, and control of HAIs and other infectious
diseases and for the optimization of antibiotic use through
stewardship. Further, we are proposing in this rule at Sec.
485.526(a)(1) that the REH ensure that an individual (or individuals),
who are qualified through education, training, experience, or certified
in infection, prevention and control, are appointed by the governing
body, or responsible individual, as the infection preventionist(s)/
infection control professional(s) responsible for the infection
prevention and control program at the REH and that the appointment is
based on the recommendations of medical staff and nursing leadership.
At Sec. 485.526(a)(2) we propose that the infection prevention and
control program, as documented in its policies and procedures, employ
methods for preventing and controlling the transmission of infections
within the REH and between the REH and other health care settings. The
program, as documented in its policies and procedures, would have to
employ methods for preventing and controlling the transmission of
infection within the REH setting (for example, among patients,
personnel, and visitors) as well as between the REH (including
outpatient services) and other institutions and health care settings.
At Sec. 485.526(a)(3) we are proposing that the infection prevention
and control program include surveillance, prevention, and control of
HAIs, including maintaining a clean and sanitary environment to avoid
sources and transmission of infection, and that the program also
address any infection control issues identified by public health
authorities. We are proposing at Sec. 485.526(a)(4) that the infection
prevention and control program reflect the scope and complexity of the
services provided by the REH.
At Sec. 485.526(b)(1) we propose to set standards for the
organization and policies of the antibiotic stewardship program.
Specifically, we propose to require that the REH's governing body
ensure that an individual, who is qualified through education,
training, or experience in infectious diseases and/or antibiotic
stewardship is appointed as the leader of the antibiotic stewardship
program and that the appointment is based on the recommendations of
medical staff and pharmacy leadership. The proposed requirements at
Sec. 485.526(b)(2)(i) through (iii) would ensure that certain goals
for an antibiotic stewardship program are met. These include
demonstrating coordination among all components of the REH responsible
for antibiotic use and resistance, including, but not limited to, the
infection prevention and control program, the QAPI program, the medical
staff, and nursing and pharmacy services; documenting the evidence-
based use of antibiotics in all departments and services of the REH;
and documenting improvements, including sustained improvements, in
proper antibiotic use. We believe that these three components are
essential for an effective program.
The provisions at Sec. 485.526(b)(3) and (4) would require the REH
to ensure that the antibiotic stewardship program adheres to nationally
recognized guidelines, as well as best practices, for improving
antibiotic use, and that the REH's stewardship program reflects the
scope and complexity of services offered. We believe these proposed
requirements are necessary to promote a facility-wide culture of
quality improvement.
We would require that the governing body or responsible individual
ensure that the infection prevention and control issues identified by
the infection prevention and control professionals be addressed in
collaboration with REH leadership. Therefore, at Sec. 485.526(c)(1)(i)
and (ii), we propose certain requirements that the governing body or
responsible individual must adhere to including--
Ensuring systems are in place and operational for the
tracking of all infection surveillance, prevention, and control, and
antibiotic use activities to demonstrate the implementation, success,
and sustainability of such activities; and
Ensuring all HAIs and other infectious diseases identified
by the infection prevention and control program and antibiotic use
issues identified by the antibiotic stewardship program are addressed
in collaboration with REH QAPI leadership.
At Sec. 485.526(c)(2)(i) through (vi), we propose that the
responsibilities of the infection prevention and control professionals
would include the development and implementation of facility-wide
infection surveillance, prevention, and control policies and procedures
that adhere to nationally recognized guidelines. The infection
preventionist(s)/infection control professional(s) would be responsible
for all documentation, written or electronic, of the infection
prevention and control program and its surveillance, prevention, and
control activities.
[[Page 40362]]
Additionally, the infection preventionist(s)/infection control
professional(s) would be responsible for the following--
Communication and collaboration with the REH's QAPI
program on infection prevention and control issues;
Competency-based training and education of REH personnel
and staff including professional health care staff and, as applicable,
personnel providing services in the REH under agreement or arrangement,
on the practical applications of infection prevention and control
guidelines, policies and procedures;
Prevention and control of HAIs, including auditing of
adherence to infection prevention and control policies and procedures
by REH personnel; and
Communication and collaboration with the antibiotic
stewardship program.
At Sec. 485.526(c)(3), we propose requirements for the leader(s)
of the antibiotic stewardship program that are similar, but not
identical, to the proposed responsibilities for the REH's designated
infection preventionist(s)/infection control professional(s) at
proposed Sec. 485.526(c)(2). We believe that an REH's antibiotic
stewardship program is the most effective means for ensuring
appropriate antibiotic use. We also believe that such a program would
require a leader who is responsible and accountable for its success.
Therefore, we propose that the leader of the antibiotic stewardship
program would be responsible for the development and implementation of
a facility-wide antibiotic stewardship program, based on nationally
recognized guidelines, to monitor and improve the use of antibiotics.
We do not expect that each new leader would develop a new antibiotic
stewardship program, unless it is determined that a new program is
necessary. We also propose that the leader of the antibiotic
stewardship program would be responsible for all documentation, written
or electronic, of antibiotic stewardship program activities. The leader
would also be responsible for communicating and collaborating with
medical and nursing staff, pharmacy leadership, and the REH's infection
prevention and control and QAPI programs, on antibiotic use issues.
We also propose that the leader would be responsible for the
competency-based training and education of REH personnel and staff,
including medical staff, and, as applicable, personnel providing
contracted services in the REH, on the practical applications of
antibiotic stewardship guidelines, policies, and procedures.
Similar to a standard in the hospital CoPs, we propose a standard
at Sec. 485.526(d) for REHs that would allow for the governing body of
an REH that is part of a system consisting of multiple, separately
certified hospitals, CAHs, and/or REHs using a single system governing
body that is legally responsible for the conduct of two or more
hospitals, CAHs, and/or REHs, to elect to have unified and integrated
infection prevention and control and antibiotic stewardship programs
for all of its member facilities, including any REHs, after determining
that such a decision is in accordance with all applicable state and
local laws. We are proposing a similar standard for CAHs at Sec.
485.640(g), which is discussed in section B.3 of this proposed rule.
The system's single governing body would be responsible for ensuring
that each of its separately certified REHs met the requirements of this
section. We note that each separately certified REH subject to the
system's single governing body would need to demonstrate that the
unified and integrated infection prevention and control and antibiotic
stewardship programs:
Were established in a manner that takes into account each
member REH's unique circumstances and any significant differences in
patient populations and services offered in each REH;
Established and implemented policies and procedures to
ensure that the needs and concerns of each of its separately certified
REHs, regardless of practice or location, are given due consideration;
and
Had mechanisms in place to ensure that issues localized to
particular REHs were duly considered and addressed.
The REH would also need to demonstrate that it had designated a
qualified individual (or individuals) with expertise in infection
prevention and control and in antibiotic stewardship at the REH to be
responsible for:
Communicating with the system's unified infection
prevention and control and antibiotic stewardship programs;
Implementing and maintaining the policies and procedures
governing infection prevention and control and antibiotic stewardship
as directed by the unified infection prevention and control and
antibiotic stewardship programs; and
Providing education and training on the practical
applications of infection prevention and control and antibiotic
stewardship to REH staff.
Finally, in response to the COVID-19 pandemic, on September 2,
2020, CMS published an interim final rule with comment period to track
the incidence and impact of COVID-19 to assist public health officials
in detecting outbreaks and saving lives (85 FR 54820). CMS then
published a final rule with comment containing reporting requirements
for hospitals and CAHs to report acute respiratory illness during the
public health emergency (PHE) for COVID-19 (85 FR 86304) on December 4,
2020. Lastly, on November 5, 2021, CMS published an interim final rule
with comment establishing COVID-19 vaccination requirements for most
Medicare- and Medicaid-certified providers and suppliers (86 FR 61623).
Consistent with the recent changes we made to the hospital and CAH
infection control CoPs related to COVID-19 (87 FR 28108) and the
declared PHE, we are proposing the following three standards in this
proposed rule for REHs:
Reporting of data related to viral and bacterial pathogens
and infectious diseases of pandemic or epidemic potential, which would
require an REH to electronically report information on Acute
Respiratory Illness (including, but not limited to, Seasonal Influenza
Virus, Influenza-like Illness, and Severe Acute Respiratory Infection),
SARS-CoV-2/COVID-19, and other viral and bacterial pathogens and
infectious diseases of pandemic or epidemic potential only when the
Secretary has declared a Public Health Emergency, directly related to
such specific pathogens and infectious diseases.
COVID-19 reporting, which would require an REH to
electronically report information about COVID-19 and seasonal influenza
in a standardized format specified by the Secretary, including the
REH's current inventory supplies of any COVID-19-related therapeutics
that have been distributed and delivered to the REH and the current
usage rate for those therapeutics beginning at the conclusion of the
COVID-19 PHE, and continuing until April 30, 2024, unless the Secretary
specifies an earlier end date.
COVID-19 Vaccination of REH staff, which would require the
REH to develop and implement policies and procedures to ensure that all
staff, with the exception of those with valid exemptions, are fully
vaccinated for COVID-19 until November 4, 2024, unless the Secretary
specifies an earlier end date for the requirements of this paragraph.
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 establishes a general 3-year timeline for
publishing a Medicare final regulation after a
[[Page 40363]]
proposed regulation or an interim final regulation has been published.
The referenced November 4, 2024 date aligns with the statutory 3-year
``Section 902'' deadline for the IFC that implemented the COVID-19
staff vaccination requirements for the provider and supplier types
covered under that rule.
14. Condition of Participation: Staffing and Staff Responsibilities
(Proposed Sec. 485.528)
Sections 1861(kkk)(1)(B)(i) and (ii) of the Act require that the
emergency department of the REH be staffed 24 hours a day, 7 days a
week. We propose to implement this requirement at Sec. 485.528(a). The
statute does not speak to the type of staff at the REH that is required
to fulfill this role. As such, we believe that REHs should have the
flexibility to determine how to staff the emergency department at the
REH 24 hours, 7 days a week. We expect that the individual(s) staffing
the emergency department is competent to receive patients and activate
the appropriate medical resources for the treatment of the patient.
This includes, but is not limited to notifying a practitioner of the
patient's arrival in the emergency department. Such staff may include a
nurse, nursing assistant, clinical technician, or an emergency medical
technician, (EMT).
Furthermore, in accordance with section 1861(kkk)(1)(B)(iii) of the
Act, we propose for REHs to meet the applicable CAH requirements at
Sec. 485.631 for staffing and staff responsibilities. We believe that
many of the CAH staffing requirements are appropriate for application
to REHs and as a result, at Sec. 485.528(b) through (e), we set for
the proposed standards for staffing, responsibilities of the doctor of
medicine or osteopathy, physician assistant, nurse practitioner, and
clinical nurse specialist responsibilities similar to CAHs. For
instance, the CAH CoPs require at Sec. 485.631(a)(5) that a registered
nurse, clinical nurse specialist, or licensed practical nurse is on
duty whenever the CAH has one or more inpatients. Since REHs are
required to furnish emergency services and observation care, we are
proposing a similar requirement as CAHs to require that a registered
nurse, clinical nurse specialist, or licensed practical nurse be on
duty whenever the REH has one or more patients receiving emergency
services or observation care.
We also propose to require standards for the periodic review of
clinical privileges and performance that are also identical to the CAH
standards at Sec. 485.631, with the exception of the CAH standard at
Sec. 485.631(b)(1)(iv), which requires that the CAH periodically
review and sign the records of all inpatients cared for by nurse
practitioners, clinical nurse specialists, certified nurse midwives, or
physician assistants. We are not proposing this standard for REHs given
that the REH would provide outpatient services exclusively.
We do not believe that it is necessary to apply the CAH requirement
that a doctor of medicine or osteopathy, nurse practitioner, clinical
nurse specialist, or physician assistant is available to furnish
patient care services at all times the CAH operates (Sec.
485.631(a)(4)) to REHs. Instead, we are proposing to require that the
REH standards align with the CAH emergency services requirements at
Sec. 485.618. The CAH provision at Sec. 485.618(d) requires that
there be a doctor of medicine or osteopathy, a physician assistant, a
nurse practitioner, or a clinical nurse specialist, with training or
experience in emergency care, on call and immediately available by
telephone or radio contact, and available on site within specified
timeframes. This allows for the alignment of the REH proposed
provisions with the CAH emergency services standards, as required by
the statute.
In response to the REH RFI, commenters indicated that CMS should
require board-certified emergency physicians to serve as medical
directors of the REH. While we agree that having a board-certified
emergency physician serving as the medical director of the REH would
benefit patients by ensuring that the REH is overseen by a highly
qualified physician with a high level of expertise in emergency
medicine, we believe that requiring this of REHs would be unduly
burdensome due to the challenges faced by rural communities in
obtaining and retaining medical professionals to provide health care
services. While we are not proposing to require that REHs have a board-
certified emergency physician serve as the medical director, we would
encourage REHs to have such a physician serve in the capacity of
medical director if possible.
15. Condition of Participation: Nursing Services (Proposed Sec.
485.530)
The CoPs for hospitals and CAHs include a provision for nursing
services. However, given that each of these providers offers acute care
inpatient services, we do not believe that all of the nursing services
requirements for hospitals and CAHs would be appropriate for REHs,
which is an outpatient-only provider. In evaluating the appropriateness
of nursing services requirements for REHs, we also took into
consideration the CfCs for ambulatory surgery centers at 42 CFR part
416 since they only offer outpatient services.
Consistent with the hospital requirements, we propose to require
that REHs have an organized nursing service that is available to
provide 24-hour nursing services at Sec. 485.530 for the provision of
patient care. We believe that the REH should have a sufficient number
of nurses available to provide services, based on the number of
patients receiving services in the REH and the level of care required
to be provided to those patients.
Similar to the standard hospitals at Sec. 482.23(a), we propose at
Sec. 485.530(a) to require that patient care responsibilities must be
delineated for all nursing service personnel and that nursing services
must be provided in accordance with recognized standards of practice.
Also consistent with the hospital standards for nursing services, we
propose to require at Sec. 485.530(b) that the REH have a director of
nursing who is a licensed registered nurse and who is responsible for
the operation of the nursing services.
16. Condition of Participation: Discharge Planning (Proposed Sec.
485.532)
Hospitals and CAHs have very similar discharge planning
requirements at Sec. Sec. 482.43 and 485.642, respectively. These
requirements were revised in the final rule entitled ``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'' (84 FR 51836). Many
commenters on the REH RFI noted the importance of having in-depth
discharge planning requirements for REHs, highlighting the need for REH
patients to have safe, well-coordinated discharge processes due to the
availability of fewer health care resources in rural environments. As a
result, we propose to closely align the proposed discharge planning
requirements for REHs with the requirements for hospitals and CAHs.
Specifically, we are proposing at Sec. 485.532 to require that the
patient's discharge plan address the patient's goals of care and
treatment preferences. During the discharge planning process, we would
expect that the appropriate medical staff would discuss the patient's
post-acute care goals and treatment preferences with the patient, the
patient's family or their caregiver/
[[Page 40364]]
support persons (or both) and subsequently document these goals and
preferences in the medical record. We would expect these documented
goals and treatment preferences to be taken into account throughout the
entire discharge planning process. We note that as a provider of
emergency services, the REH may receive patients from nursing homes who
require emergency care. Having a robust discharge planning process in
place is imperative for this patient population. There may be instances
in which a patient comes to the REH from a nursing home and the nursing
home expresses an intent not to accept the patient or delays the
patient's return back to the nursing home after the completion of
emergency care by the REH. Under these circumstances, we would
encourage the REH to contact their State's long-term care ombudsman or
State Survey Agency. We also encourage the REH to inform patients who
arrive from or are discharged to a long-term care facility about how to
contact the Ombudsman and State Survey Agency, as there may be quality
of care or quality of life concerns to be reported. The Administration
of Community Living's Long-Term Care Ombudsman Programs, ``. . . work
to resolve problems related to the health, safety, welfare, and rights
of individuals who live in LTC facilities, such as nursing homes, board
and care and assisted living facilities, and other residential care
communities. Ombudsman programs promote policies and consumer
protections to improve long-term services and supports at the facility,
local, state, and national levels.'' \19\
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\19\ Administration of Community Living (2021). Long-Term Care
Ombudsman Program. https://acl.gov/programs/Protecting-Rights-and-Preventing-Abuse/Long-term-Care-Ombudsman-Program.
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At Sec. 485.532(a) introductory text and (a)(1), we propose to
require that REHs implement a discharge planning process to begin
identifying, early in the provision of services, the anticipated post-
discharge goals, preferences, and needs of the patient and begin to
develop an appropriate discharge plan for patients who are likely to
suffer adverse health consequences upon discharge in the absence of
adequate discharge planning. Timely identification of the patient's
goals, preferences, and needs and development of the discharge plan
would reduce delays in the overall discharge process. Patient referrals
to or consultation with community care organizations will be a key
step, for some, in assuring successful patient outcomes. Therefore, we
believe that discharge planning for patients is a process that involves
the consideration of the patient's unique circumstances, treatment
preferences, and goals of care, and is not solely a documentation
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 remind providers of their obligations to 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). Discharge planning would be of little value to patients
who cannot understand or appropriately follow the discharge plans
discussed in this proposed rule. Without appropriate language
assistance or auxiliary aids and services, discharge planners would not
be able to fully involve the patient and caregiver/support person in
the development of the discharge plan. Furthermore, the discharge
planner would not be fully aware of the patient's goals for discharge.
Additionally, effective discharge planning would assist REHs in
complying with the U.S. Supreme Court's holding in Olmstead v. L.C.
(527 U.S. 581 (1999)), which found that the unjustified segregation of
people with disabilities is a form of unlawful discrimination under the
ADA. We note that effective discharge planning may assist REHs in
ensuring that individuals being discharged who would otherwise be
entitled to institutional services, have access to community-based
services when--(1) such placement is appropriate; (2) the affected
person does not oppose such treatment; and (3) the placement can be
reasonably accommodated. As noted by comments received in response to
the REH RFI, discharge planning should focus on returning the patient
to a home or community-based setting to the fullest extent possible
with necessary supports and service. These proposed discharge planning
standards are aimed at achieving this goal.
At Sec. 485.532(a)(2), we propose to require an REH to perform a
discharge planning evaluation that must include an evaluation of a
patient's likely need for appropriate services following care that has
been furnished by an REH, including, but not limited to, hospice care
services, post-REH 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.
At Sec. 485.532(a)(3) we propose to require that the patient's
discharge needs evaluation and discharge plan must be documented and
completed on a timely basis, based on the patient's goals, preferences,
strengths, and needs, so that appropriate arrangements for post-REH
care are made before discharge. This requirement would prevent the
patient's discharge or transfer from being unduly delayed. We expect
that in response to this requirement, REHs would establish more
specific time frames for completing the evaluation and discharge plans
based on the needs of their patients and their own operations. All
relevant patient information would be incorporated into the discharge
plan to facilitate its implementation and the discharge plan must be
included in the patient's medical record. The results of the evaluation
must also be discussed with the patient or patient's representative.
Furthermore, we believe that REHs will use their evaluation of the
discharge planning process, with solicitation of feedback from other
providers and suppliers in the community, as well as from patients and
caregivers, to revise their timeframes, as needed. We encourage REHs to
make use of available health information technology, such as electronic
health records, as well as entities that can facilitate exchange, such
as health information exchanges, to enhance the efficiency and
effectiveness of their discharge process.
At Sec. 485.532(a)(4), we propose to require the REH to arrange
for the development and initial implementation of a discharge plan for
those patients so identified as well as for other patients upon the
request of the patient's physician. We propose at Sec. 485.532(a)(5)
to require that a registered nurse, social worker, or other personnel
qualified in
[[Page 40365]]
accordance with the REH's discharge planning policy coordinate the
discharge needs evaluation and the development of the discharge plan.
At Sec. 485.532(a)(6) we propose to require that the REH's
discharge planning process must ensure an ongoing patient evaluation
throughout the patient's REH stay or visit to identify any changes in
the patient's condition that would require modifications to the
discharge plan. The evaluation to determine a patients continued stays
at the REH (or in other words, their readiness for discharge or
transfer), is a current standard of medical practice.
We propose to require at Sec. 485.532(a)(7) that the hospital
assess its discharge planning process on a regular basis and include,
as part of the assessment, an ongoing review of a representative sample
of discharge plans. We expect that this would include patients who were
emergency department revisits, or presented to the emergency department
within 30 days of a previous visit, to ensure that the REH is
responsive to the discharge needs of patients.
In addition to standards for evaluating the discharge needs of
patients and the development of discharge plans, the hospital and CAH
discharge planning provisions also require that the hospital and CAH
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, home health agency (HHA), SNF,
inpatient rehabilitation facility (IRF), or long-term care hospital
(LTCH) data on quality measures and data on resource use measures.
Furthermore, the CoPs require the hospital and CAH to 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. We believe these requirements are applicable to
REHs given that we expect some patients of the REH to be discharged to
a post-acute care provider. As result, we propose at Sec.
485.532(a)(8) to require REHs to share data on quality measures and
resource use measures of local post-acute care providers with patients
to assist them in selecting a post-acute care provider.
We propose at Sec. 485.532(b) to require that the REH 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.
The Agency for Healthcare Research and Quality released an
environmental scan report on Improving the Emergency Department
Discharge Process, that evaluated the state of the emergency department
discharge process and ways in which it can be improved.\20\ The report
found that a high-quality emergency department discharge incorporates
the following:
---------------------------------------------------------------------------
\20\ Johns Hopkins University, Armstrong Institute for Patient
Safety and Quality (2014). Improving the emergency department
discharge process: environmental scan report. (Prepared by Johns
Hopkins University, Baltimore, MD, under Contract No. HHSA
2902010000271.). Agency for Healthcare Research and Quality;
Publication No. 14(15)-0067-E. https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/systems/hospital/edenvironmentalscan/edenvironmentalscan.pdf.
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Informs and educates patients on their diagnosis,
prognosis, treatment plan, and expected course of illness. This
includes informing patients of the details of their visit (treatments,
tests, procedures).
Supports patients in receiving post-emergency department
discharge care. This might include medications, home care of injuries,
use of medical devices/equipment, further diagnostic testing, and
further health care provider evaluation.
Coordinates emergency department care within the context
of the health care system (other health care providers, social
services, etc.).
We believe discharge planning requirements proposed for REHs
address the goals identified in the report.
17. Condition of Participation: Patient's Rights (Proposed Sec.
485.534)
It is imperative for patients to have the ability to exercise
certain rights and protections while seeking and receiving necessary
care and services at an REH. As previously mentioned, the appropriate
provision of behavioral health is very important in the treatment and
safety of patients and staff. Behavioral health is a challenge in rural
areas, due to the accessibility, affordability, acceptability and
availability of these services. We anticipate beneficiaries may rely on
REH's to access behavioral health care services, therefore we believe
it is important to have policies and procedures in place for REHs and
CAHs (discussed later in this rule) in the event of a mental health
crisis and the need for the use of restraints and seclusions. We
propose to establish a CoP for patient's rights at Sec. 485.534 that
would set forth the rights of all patients to receive care in a safe
setting and provide protection for a patient's emotional health and
safety as well as their physical safety. Furthermore, we propose to
establish the patient's rights CoP for REHs closely to the patient's
rights CoP for hospitals at Sec. 482.13. This would include proposed
requirements for the REH to inform patients of and exercise their
rights, address privacy and safety, adhere to the confidentiality of
patient records, responsibilities for the use of restraint and
seclusion, and adherence to patient visitation rights. We propose to
add these same patient's rights CoPs for CAHs, as well. Some of these
requirements are currently in the SOM for CAHs while some are not
explicitly required. We believe that these patient rights provisions
are important for hospitals, CAHs, and REHs. However, we note that some
of the provisions proposed in this section for REHs and, also for CAHs
as discussed later, are less prescriptive than those for hospitals
because we are proposing to allow for these providers to develop
policies and procedures based on the scope of services they provide and
patient populations that they serve. For example, we believe that REHs,
like CAHs, will have a lower volume of patients than hospitals and the
use of restraints and seclusion would not be as frequent as other
providers. REHs would not be providing inpatient services and if a
patient presents at the REH in crisis or needing a level of care so
acute that restraints or seclusions may become necessary, we would
expect the REH to arrange for the transfer of the patient to a higher
level of care. We are specifically soliciting comments on the
appropriateness of the patient's rights requirements proposed for
restraint and seclusion, the potential need to require standards that
are more stringent to address patient protections, and the feasibility
of implementing such requirements in rural communities.
Notice of Rights
At Sec. 485.534(a), we propose that an REH must inform each
patient, or when appropriate, the patient's representative (as allowed
under state law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible. This includes a proposal
to require the REH to establish a process for the oversight and prompt
resolution of patient grievances and for informing each patient whom to
contact to file a grievance.
[[Page 40366]]
Exercise of Rights
At Sec. 485.534(b), we propose to specify those rights a patient
has regarding their medical care, which includes the right to make
informed decisions regarding their care, to be fully informed about
such care, and the right to request or refuse treatment. We note that
this right must not be construed as a mechanism to demand the provision
of treatment or services deemed medically unnecessary or inappropriate.
In addition, we propose to specify that the patient also has the right
to formulate advance directives and to have REH staff and practitioners
who provide care in the REH comply with these directives.
Privacy, Safety, and Confidentiality of Patient Records
At Sec. 485.534(c), we propose to specify that the patient has the
right to personal privacy, receive care in a safe setting, and be free
from all forms of abuse or harassment. At Sec. 485.534(d), we propose
to specify that the patient has the right to the confidentiality of
their medical records and the right to access their medical records.
When requested, we propose that the REH must provide the patient with
their records in a form and format requested by the requestor and
within a reasonable timeframe, as not to frustrate the legitimate
efforts of individuals to gain access to their own medical records.
Use of Restraints and Seclusion
At Sec. 485.534(e), we propose those patient's rights relating to
the use of restraints and seclusion. We are proposing requirements that
are less burdensome than those existing restraint and seclusion
requirements for hospitals because given the level of services provided
by REHs and the anticipated patient volume, we expect the likelihood of
their need to utilize restraints and seclusion to be relatively low. In
addition, in the event that there are patients requiring restraint and
seclusion we would expect them to be transferred to a higher level of
care. We note that we have similar expectations for CAHs and are
proposing similar requirements for CAHs in this rule. Specifically, we
propose to specify that all patients have the right to be free from
physical or mental abuse, from corporal punishment, and from restraint
or seclusion, of any form, imposed as a means of coercion, discipline,
convenience, or retaliation by staff. We propose that restraint or
seclusion may only be imposed to ensure the immediate physical safety
of the patient, a staff member, or others and must be discontinued at
the earliest possible time. We propose to define restraint as any
manual method, physical or mechanical device, material, or equipment
that immobilizes or reduces the ability of a patient to move their
arms, legs, body, or head freely; or a drug or medication when it is
used as a restriction to manage the patient's behavior or restrict the
patient's freedom of movement and is not a standard treatment or dosage
for the patient's condition. A restraint does not include devices, such
as orthopedically prescribed devices, surgical dressings or bandages,
protective helmets, or other methods that involve the physical holding
of a patient for the purpose of conducting routine physical
examinations or tests, or to protect the patient from falling out of
bed, off of a stretcher, or out of a chair, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort). We propose to define seclusion as the
involuntary confinement of a patient alone in a room or area from which
the patient is physically prevented from leaving. Seclusion may only be
used for the management of violent or self-destructive behavior.
At Sec. 485.534(e)(2), we propose to require that the restraint or
seclusion may only be used when less restrictive interventions have
been determined to be ineffective to protect the patient, a staff
member, or others from harm, and at Sec. 485.534(e)(3) that the type
or technique of restraint or seclusion used must be the least
restrictive intervention that will be effective to protect the patient,
staff member, or others from harm. At Sec. 485.534(e)(4), we propose
that the REH must have written policies and procedures regarding the
use of restraint and seclusion that are consistent with current
standards of practice. These requirements allow for the REH to use
restraints and seclusion in the event that it is necessary and as a
last resort to respond to immediate safety concerns, but lessens the
burden and allows for more flexibility than the existing hospital CoPs.
We believe that allowing the REH the flexibility to develop their own
policies and procedures for restraints and seclusion based on the scope
of services they provide is necessary given their patient volumes,
populations, and access to resources. We propose to require that the
policies and procedures that are developed be consistent with current
standards of practice. As noted, we are soliciting comments on the
appropriateness of the patient's rights requirements proposed for
restraint and seclusion, the potential need to require standards that
are more stringent to address patient protections, and the feasibility
of implementing such requirements in rural communities.
Staff Training Requirements for the Use of Restraints or Seclusion
The following staff training requirements are not as prescriptive
as the existing hospital requirements, and we are proposing these same
requirements for CAHs in this rule. At Sec. 485.534(f) we propose to
establish staff training requirements for the use of restraints and
seclusion. Specifically, we propose that the patient has the right to
safe implementation of restraint or seclusion by trained staff. We
propose at Sec. 485.534(f)(1) that the REH must provide competency-
based training and education of REH personnel and staff, including
medical staff, and, as applicable, personnel providing contracted
services in the REH, on the use of restraint and seclusion. To ensure
that the use of restraint and seclusion for patients receiving services
in an REH is respectful of, and responsive to, individual patient
preferences, needs and values, we propose to require that the training
be patient-centered. Additionally, to ensure that staff are educated
and trained on using the least restrictive intervention necessary for
the safety of the patients and REH staff, we propose at Sec.
485.534(f)(2) to require that the REH staff train their staff in
alternatives to the use of restraint and seclusion. For example, staff
should have trauma-informed knowledge competencies and be aware of
effective de-escalation techniques that can be used to avoid the use of
restraint and seclusion and the trauma that may be associated with
their use. Trained peer workers (people who share similar experiences
of being diagnosed with mental health conditions, substance use
disorders, or both) and community health workers (CHWs) may also serve
a useful role in assisting patients and other staff. This could include
helping to monitor use of restraint and seclusion, deescalating
interactions with patients and contributing to a positive and
supportive environment for patients, family members, and REH staff.
REHs are encouraged to consider the use of peer workers and CHWs in
their staffing plans. For further information, please see the 2007
guidance on use of peers in the Medicaid program (https://www.medicaid.gov/federal-policy-guidance/downloads/SMD081507A.pdf) and
resources from the Substance Abuse and Mental Health Services
Administration (https://www.samhsa.gov/brss-tacs/recovery-
[[Page 40367]]
support-tools/peers). In addition, facilities are encouraged to
consider any nutritional needs while a patient is restrained, such as a
need to provide food and water.
Death Reporting Requirements
The following requirements are similar to the hospital requirements
at Sec. 482.13. At Sec. 485.534(g), we propose to establish
requirements that REHs must follow when reporting deaths associated
with the use of seclusion or restraint. Specifically, we propose to
require that the REH must report to CMS, by telephone, facsimile, or
electronically, as determined by CMS, no later than the close of
business on the next business day the following information--(1) Each
death that occurs while a patient is in restraint or seclusion; (2)
Each death that occurs within 24 hours after the patient has been
removed from restraint or seclusion; (3) Each death known to the REH
that occurs within 1 week after restraint or seclusion where it is
reasonable to assume that use of restraint or placement in seclusion
contributed directly or indirectly to a patient's death, regardless of
the type(s) of restraint used on the patient during this time. We note
that ``reasonable to assume'' in this context would include, but is not
limited to, deaths related to restrictions of movement for prolonged
periods of time, or death related to chest compression, restriction of
breathing, or asphyxiation.
For instances when no seclusion has been used and when the only
restraints used on the patient are those applied exclusively to the
patient's wrist(s), and which are composed solely of soft, non-rigid,
cloth-like materials, the REH staff must record in an internal log or
other system, the following information--(1) Any death that occurs
while a patient is in such restraints; (2) Any death that occurs within
24 hours after a patient has been removed from such restraints.
Furthermore, we propose that staff must also document in the patient's
medical record the date and time the death was reported to CMS or
recorded in the internal log or other system. Also, for instances when
no seclusion has been used and when the only restraints used on the
patient are those applied exclusively to the patient's wrist(s),we
propose to require that entries into the internal log or other system
must be documented no later than seven days after the date of death of
the patient, include the patient's name, date of birth, date of death,
name of attending physician or other licensed practitioner who is
responsible for the care of the patient, medical record number, and
primary diagnosis(es), and to be made available in either written or
electronic form to CMS immediately upon request.
Patient Visitation Rights
At Sec. 485.534(h), we propose to establish requirements related
to a patient's visitation rights. These requirements are consistent
with the current hospital and CAH regulations. Specifically, we propose
to require that an REH must have written policies and procedures
regarding the visitation rights of patients, including those setting
forth any clinically necessary or reasonable restriction or limitation
that the REH may need to place on such rights and the reasons for the
clinical restriction or limitation. An REH must inform patients (or
support persons, where appropriate) of their visitation rights,
including any clinical restriction or limitation on such rights, when
they are informed of their other rights. Each patient should be
informed (or support persons, where appropriate) of the right, subject
to their consent, to receive the visitors whom they designate,
including, but not limited to, a spouse, a domestic partner (including
a same-sex domestic partner), another family member, or a friend. The
patient also has the right to withdraw or deny such consent at any
time, not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability, and ensure that all
visitors enjoy full and equal visitation privileges consistent with
patient preferences.
18. Condition of Participation: Quality Assessment and Performance
Improvement Program (QAPI program) (Proposed Sec. 485.536)
Patient safety and quality improvement remains a challenge in our
nation's hospitals. In 2001, the Institute of Medicine (IOM) released a
pivotal report, ``Crossing the Quality Chasm'' in which it stated that
``the American healthcare delivery system is in need of fundamental
change'' and recognized that ``quality problems are everywhere
affecting many patients.'' \21\ In a 2004 educational publication co-
sponsored by the Office of Inspector General (OIG) of the U.S.
Department of Health and Human Services and the American Health Lawyers
Association (AHLA), Corporate Responsibility and Health Care Quality: A
Resource for Health Care Boards of Directors, the authors discuss the
IOM report and state that the oversight of quality and patient safety
is becoming clearly recognized as a core fiduciary responsibility of
health care organizations.\22\ They further note that promoting quality
of care and preserving patient safety are at the core of the health
care industry and the reputation of each health care organization and
suggest that ``contemporary health care quality, patient safety and
cost efficiency initiatives provide an opportunity for health care
organizations to make a positive difference to society while promoting
their missions and enhancing their financial success.'' In their 2013
expert panel report, the Association of American Medical Colleges
describes the work of the competent health professional as not only
delivering health care, but also working to improve it, including
identifying problems in care delivery and working with others to
enhance performance.\23\
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\21\ Institute of Medicine (US) Committee on Quality of Health
Care in America. Crossing the Quality Chasm: A New Health System for
the 21st Century. Washington (DC): National Academies Press (US);
2001. Available from: https://www.ncbi.nlm.nih.gov/books/NBK222274/
doi: 10.17226/10027.
\22\ United States Department of Health and Human Services,
Office of Inspector General & American Health Lawyers Association.
(2004). Corporate Responsibility and Health Care Quality: A Resource
for Health Care Boards of Directors. https://oig.hhs.gov/documents/compliance-guidance/813/CorporateResponsibilityFinal_9-4-07.pdf.
\23\ Association of American Medical Colleges. (2014). Teaching
for Quality: Integrating Quality Improvement and Patient Safety
across the Continuum of Medical Education. https://www.aamc.org/media/26316/download?attachment.
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While progress has been made towards the goal of increased patient
safety since the publication of the 2001 IOM report, including a
reduction in hospital-acquired conditions (HACs) and hospital fall-
related injuries and improvements in patient handoffs, the mitigation
of medical errors and adverse events and protection of patient safety
remain serious concerns.24 25 26 According to 2018 data from
the Centers for Disease Control (CDC), approximately 1 in 31 hospital
patients develops an HAI, such as a surgical site infections or
catheter-related bloodstream infections (CRBIs) and the effects can be
painful, costly, and even deadly.\27\
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\24\ Agency for Healthcare and Research Quality. (2020, July)
AHRQ National Scorecard on Hospital-Acquired Conditions: Final
Results for 2014 through 2017. https://www.ahrq.gov/hai/pfp/index.html.
\25\ Dupree, E., Fritz-Campiz, A., Musheno, D. (2014). A New
Approach to Preventing Falls with Injuries. Journal of Nursing Care
Quality, 29(2), p. 99-102.
\26\ Starmer, A.J. et al. (2014). Changes in Medical Errors
after Implementation of a Handoff Program. New England Journal of
Medicine, 371, p. 1803-1812. DOI: 10.1056/NEJMsa1405556.
\27\ Centers for Disease Control and Prevention. (2018, October
5). Healthcare-Associated Infections (HAIs). HAI Data. https://www.cdc.gov/hai/data/index.html.
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[[Page 40368]]
An effective QAPI program that is engaged in continuous improvement
efforts is essential to a provider's ability to deliver high quality
and safe care to its patients, while reducing the incidence of medical
errors and adverse events. Therefore, we believe the QAPI programs for
REHs should conform to the current health care industry standards that
require providers to proactively design quality improvement into each
program at the outset, monitor data (indicators, measures and reports
of staff/residents/families), determine root causes of problems,
develop and implement plans that affect system improvement, and monitor
the success of this systematic approach to improving quality.
At Sec. 485.536, we propose to require that every REH develop,
implement, and maintain an effective, ongoing, REH-wide, data-driven
QAPI program. This requirement would ensure that the REH systematically
reviews its operating systems and processes of care to identify and
implement opportunities to deliver effective care to its patients
focusing on improving health outcomes and preventing and reducing
medical errors.
In the development of the proposed requirements for the REH QAPI
program, we reviewed the CAH QAPI requirements at Sec. 485.641, which
we note are also closely aligned with the hospital QAPI requirements at
Sec. 482.21. We also took into account the comments on the REH RFI and
input from other interested parties who requested that CMS consider the
clinical and administrative limitations that rural providers experience
and, where appropriate, we have proposed requirements that minimize
burden while maintaining the ability of the REH to proactively maximize
quality improvement activities and programs.
The proposed QAPI program contains the following five parts: (a)
Program and scope; (b) Program data collection and analysis; (c)
Program activities; (d) Executive responsibilities; and (e) Unified and
integrated QAPI program for an REH in a multi-hospital system.
Similar to the program scope standard for hospitals at Sec.
482.21(a)(1) and (2), at Sec. 485.536(a)(1), we propose to require the
REH to have an ongoing QAPI program that reflects improvement in
quality indicators related to health outcomes and reductions in medical
errors. In proposed paragraph Sec. 485.536(a)(2) we would require REHs
to measure, analyze, and track these quality indicators. At Sec.
485.536(b), we propose to mirror the program data collection and
analysis standard for CAHs at Sec. 485.641(b) and require that the
REH's QAPI program incorporate quality indicator data including patient
care data, quality measures data, and other relevant data in order to
attain quality improvement.
Similar to the program activities standard for hospitals at Sec.
482.21(c), at Sec. 485.536(c)(1), we propose to require the REH to set
priorities for its performance improvement activities and that these
activities are focused on high-risk, high-volume, or problem-prone
areas. We also propose to require the REH to consider the incidence,
prevalence, and severity of problems in those identified areas and that
the set priority areas affect health outcomes, patient safety, and
quality of care. At Sec. 485.536(c)(2) and (3), we propose to require
the REH's performance improvement activities to track medical errors
and adverse events, analyze their cause, and implement preventive
actions. We would expect the REH to conduct analyses at regular
intervals to track performance and ensure that improvements are
sustained.
We propose at Sec. 485.536(d), similar to the standard for
executive responsibilities for hospitals at Sec. 482.21(e) that the
responsibilities for the REH's governing body (or organized group or
individual who assumes full legal authority and responsibility for
operations of the REH), medical staff, and administrative officials
include ensuring that the QAPI program is implemented and maintained,
properly evaluated, and appropriately resourced.
Lastly, consistent with the standard included at Sec. 482.21(f) in
the hospital CoPs for QAPI programs, we are proposing at Sec.
485.536(e) to allow REHs that are part of a multi-facility system
consisting of multiple separately certified hospitals, CAHs, and/or
REHs to elect to have a unified and integrated QAPI program if in
accordance with all applicable state and local laws. Specifically, we
propose to specify that the system's governing body would be
responsible and accountable for ensuring that each of its separately
certified REHs met the proposed QAPI program requirements. We expect
this allowance, if finalized, would be beneficial to REHs that may lack
time, resources or staff to implement an REH-specific QAPI program. The
REH would be able to benefit from the resources and expertise of a
multi-hospital system in implementing their QAPI program, as well as
potentially reducing the time and labor investments required to enact
and maintain the program.
We are interested in input from the public regarding possible
unintended consequences that could occur as a result of allowing REHs
to participate in a unified and integrated QAPI program. We are
interested in feedback regarding how the integrated health system's
governing body will ensure that they consider the REH's unique
circumstances and any significant differences in patient populations
and services offered at the REH. We also seek comments regarding how
the integrated health system's governing body would ensure that an REH
participating in a unified and integrated QAPI program provided the
appropriate level of care to patients being treated in the REH,
including being appropriately transferred to another facility when
necessary.
19. Condition of Participation: Agreements (Proposed Sec. 485.538)
Section 1861(kkk)(2)(C) of the Act, as added by the CAA, requires
an REH to have in effect a transfer agreement with a level I or level
II trauma center. In accordance with section 1861(kkk)(2)(C) of the
Act, at Sec. 485.538 we propose to require that REHs must have in
effect an agreement with at least one Medicare-certified hospital that
is a level I or level II trauma center for the referral and transfer of
patients requiring emergency medical care beyond the capabilities of
the REH. We would require that the level I or level II trauma center
meets certain licensure requirements including being licensed as a
hospital in a state that provides for the licensing of hospitals under
state or applicable local law or approved by the agency of such state
or locality responsible for licensing hospitals, as meeting standards
established for licensing established by the agency of the state. It is
also acceptable for the level I or II trauma center to be located in a
state other than the state where the REH is located. In addition, we
propose to require that the level I or level II trauma center must also
be licensed or designated by the state or local government authority as
level I or level II trauma center or is verified by the American
College of Surgeons as a level I or level II trauma center.
We received several comments to the REH RFI regarding transfer
agreements between REHs and hospitals that are not designated as a
level I or II trauma center. Specifically, commenters stated that due
to distance, or the possibility that level I or level II trauma centers
may not have available beds, many rural CAHs currently transfer
patients to level III or level IV trauma centers based on the patient's
specific needs. Commenters requested that CMS allow these facilities to
retain these
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agreements, should they convert to REHs. We would expect REHs to comply
with the CoP detailed at Sec. 485.538 and to have a transfer agreement
in place with a level I or II trauma center. However, we do not believe
that the statute precludes an REH from also having a transfer agreement
with a hospital that is not designated as a level I or II trauma
center. An REH may have pre-existing relationships with hospitals that
are not designated as level I or level II trauma centers. In these
instances, the proposed requirement would not preclude them from
maintaining those relationships and leveraging resources and capacity
that may be available to deliver care that is beyond the scope of care
delivered at the REH.
We note that section 125(b)(2) of the CAA also amended
subparagraphs (I) and (N) of section 1866(a)(1) of the Act, to apply
the Emergency Medical Treatment and Labor Act (EMTALA) requirements
under section 1867 of the Act, to REHs. One commenter on the REH RFI
recommended EMTALA waivers for REHs to divert patients to other
hospitals if they require a higher level of care than the REH is able
to provide. However, the statutory requirements for REHs do not allow
an EMTALA waiver.
20. Condition of Participation: Medical Records (Proposed Sec.
485.540)
The maintenance of a medical records system is a longstanding
requirement in both the hospital and CAH CoPs. In the development of
proposed requirements for medical records for REHs, we reviewed the
CoPs for medical records for CAHs established at Sec. 485.638,
including the requirements finalized in the May 2020 final rule,
``Medicare and Medicaid Programs; Patient Protection and Affordable
Care Act; Interoperability and Patient Access'' (85 FR 25510 through
25585), focused on electronic patient event notifications of a
patient's admission, discharge, and/or transfer to another health care
facility or to another community provider. We also considered the
comments from the REH RFI that encouraged CMS to closely align the CoPs
for REHs with currently established requirements for CAHs. After
reviewing the CoPs for medical records for CAHs at Sec. 485.638, we
believe that the requirements established for medical records for CAHs
are also appropriate for REHs. We also would expect that many
facilities that may elect to convert to an REH would presently have
these systems in place, which may minimize administrative burden.
Therefore, at Sec. 485.540(a), we propose to require that the REH must
maintain a medical records system in accordance with written policies
and procedures, that the records must be legible, complete, accurately
documented, readily accessible, and systematically organized and that a
designated member of the professional staff is responsible for
maintaining the records. We also propose to require that for each
patient receiving health care services, the REH maintains a record that
includes, as applicable, identification and social data, evidence of
properly executed informed consent forms, pertinent medical history,
assessment of the health status and health care needs of the patient,
and a brief summary of the episode, disposition, and instructions to
the patient. We propose that the record requirements include reports of
physical examinations, diagnostic and laboratory test results,
including clinical laboratory services, and consultative findings and
all orders of doctors of medicine or osteopathy or other practitioners,
reports of treatments and medications, nursing notes and documentation
of complications, and other pertinent information necessary to monitor
the patient's progress, such as temperature graphics or progress notes
describing the patient's response to treatment. Lastly, we propose that
the record include dated signatures of the doctor of medicine or
osteopathy or other health care professional.
At Sec. 485.540(b) and (c), we propose to require the REH to
maintain the confidentiality of record information and to ensure
records are retained for at least 5 years from date of last entry, and
longer if required by state statute, or if the records may be needed in
any pending proceeding.
Lastly, at Sec. 485.540(d), we propose a standard for electronic
notifications if the REH utilizes an electronic medical records system
or other electronic administrative system that conforms with the
content exchange standard at 45 CFR 170.205(d)(2). This requirement is
intended to limit the applicability of this CoP to those REHs which
currently possess an EHR or other electronic administrative system with
the technical capacity to generate information for electronic patient
event notifications. As discussed in the CMS Interoperability and
Patient Access final rule (85 FR 25585), electronic patient event
notifications can be an effective tool for improving care coordination
across settings, especially for patients at discharge. We propose to
require the REH to demonstrate that the system's notification capacity
is fully operational and sends notifications with at least specified
patient information, as appropriate, and facilitates the exchange of
health information when the patient is registered, discharged, or
transferred from the REH's emergency department. Finally, we propose to
require that the REH make a reasonable effort to ensure that the system
sends the notifications to certain recipients including, the patient's
applicable post-acute care and primary care services providers.
21. Condition of Participation: Emergency Preparedness (Proposed Sec.
485.542)
Over the past several years, the U.S. has been challenged by
several natural and man-made disasters. As a result of the September
11, 2001 terrorist attacks, the subsequent anthrax attacks, the
catastrophic hurricanes in the Gulf Coast states in 2005, flooding in
the Midwestern states in 2008, tornadoes and floods in the spring of
2011, the 2009 H1N1 influenza pandemic, and Hurricane Sandy in 2012 and
most recently, the COVID-19 pandemic, readiness for public health
emergencies has been put on the national agenda. On September 16, 2016,
we published a final rule, ``Medicare and Medicaid Programs; Emergency
Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers'' (81 FR 63860), to establish emergency
preparedness requirements for Medicare and Medicaid participating
providers and suppliers to plan adequately for both natural and man-
made disasters, and coordinate with Federal, state, tribal, regional,
and local emergency preparedness systems. Disasters can disrupt the
health care environment and change the demand for health care services.
This makes it essential that health care providers and suppliers ensure
that emergency management is integrated into their daily functions and
values.
Thus, we are proposing emergency preparedness requirements to
establish a comprehensive, consistent, flexible, and dynamic regulatory
approach to emergency preparedness for REHs that aligns with the
existing emergency preparedness standards for Medicare and Medicaid
participating providers and suppliers. These proposed requirements
mirror the existing CAH emergency preparedness requirements. The
emergency preparedness requirements for all Medicare-participating
providers and suppliers are consistent, with some differences based on
the provider type (such as inpatient versus outpatient).
Consistent with the standards for all Medicare and Medicaid
participating providers and suppliers, we propose to require REHs to
comply with all
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applicable Federal, state, and local emergency preparedness
requirements. In addition, we propose to require that the REH establish
and maintain an emergency preparedness program that addresses four core
elements that we believe are central to an effective emergency
preparedness system. The four elements are: (1) risk assessment and
planning; (2) policies and procedures; (3) communication; and (4)
training and testing.
At Sec. 485.542(a), we propose to require that REHs develop and
maintain an emergency preparedness plan that must be reviewed and
updated at least every 2 years. Specifically, we propose to require
that the REHs emergency plan must--(1) Be based on and include a
documented, facility-based and community-based risk assessment,
utilizing an all-hazards approach, (2) Include strategies for
addressing emergency events identified by the risk assessment, (3)
Address the patient population, including, but not limited to, the type
of services the REH has the ability to provide in an emergency; and
continuity of operations, including delegations of authority and
succession plans, and (4) Include a process for cooperation and
collaboration with local, tribal, regional, state, and Federal
emergency preparedness officials' efforts to maintain an integrated
response during a disaster or emergency situation.
At Sec. 485.542(b), we propose to require REHs to develop and
implement policies and procedures, that are based on the emergency
plan, risk assessment, and communication plan, and must be reviewed and
updated at least every 2 years. Specifically, we propose to require
that the policies and procedures must address the following:
Provision of subsistence needs for staff and patients,
whether they evacuate or shelter in place, including, but not limited
to food, water, medical and pharmaceutical supplies, other sources of
energy to maintain temperatures, emergency lighting, fire detection and
sewage and waste disposal;
A system to track the location of on-duty staff and
sheltered patients in the REH's care during an emergency, and if staff
are being relocated the REH must document the specific name and
location of the receiving facility or other location;
Safe evacuation from the REH, to include consideration of
care and treatment needs of the evacuees, staff responsibilities and
transportation and identification of the evacuation location(s);
A means to shelter in place for any patients, staff and
volunteers that remain at the REH;
A system of medical documentation that preserves patient
information, protects confidentiality of all patient information and
secures and maintains the availability of the records;
The use of volunteers in an emergency and other staffing
strategies, including the process and role for integration of state and
federally designated health care professionals to address surge needs
during an emergency; and
The role of the REH under a waiver declared by the
Secretary, in accordance with section 1135 of the Act, in the provision
of care and treatment at an alternate care site identified by emergency
management officials.
We believe that small and rural REHs would be able to develop an
appropriate emergency preparedness plan and develop policies and
procedures in accordance with our proposed requirements with the
assistance of resources in their state and local community guidance.
At Sec. 485.542(c), we propose to require REHs to develop and
maintain an emergency preparedness communication plan that complies
with both Federal and state law and must be reviewed and updated at
least every 2 years. The communication plan must include the following:
Names and contact information for staff, entities
providing services under agreement, patients' physicians and
volunteers;
Contact information for Federal, state, tribal, regional,
and local emergency preparedness staff and other sources of assistance;
Primary and alternate means for communicating with the
REH's staff and Federal, state, tribal, regional, and local emergency
management agencies;
A method for sharing information and medical documentation
for patients under the REH's care, as necessary, with other health care
providers to maintain the continuity of care;
A means, in the event of an evacuation, to release patient
information;
A means of providing information about the general
condition and location of patients under the facility's care; and
A means of providing information about the REH's needs,
and its ability to provide assistance, to the authority having
jurisdiction, the Incident Command Center, or designee.
We would expect patient care to be well-coordinated within the REH,
across healthcare providers, and with state and local public health
departments and emergency management agencies and systems to protect
patient health and safety in the event of a disaster. The following
link is to FEMA's comprehensive preparedness guide to develop and
maintain emergency operations plans: https://www.fema.gov/sites/default/files/2020-05/CPG_101_V2_30NOV2010_FINAL_508.pdf. During an
emergency, it is critical that REHs, have a system to contact
appropriate staff, patients' treating physicians, and other necessary
persons in a timely manner to ensure continuation of patient care
functions throughout the facilities and to ensure that these functions
are carried out in a safe and effective manner.
At Sec. 485.542(d), we propose to require the REH to develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan, policies and procedures and communication
plan, and reviewed and updated at least every 2 years. We propose to
require at Sec. 485.542(d)(1) that the training program include
initial training in the emergency preparedness policies and procedures
for new and existing staff, individuals providing on-site services
under arrangement, and volunteers, consistent with their expected
roles. We also propose to require the facility to provide emergency
preparedness training at least every 2 years, maintain documentation of
all emergency preparedness training, demonstrate staff knowledge of
emergency procedures, and if the emergency preparedness policies and
procedures are significantly updated, conduct training on the updated
policies and procedures. The Homeland Security Exercise and Evaluation
Program (HSEEP), developed by FEMA, includes a section on the
establishment of a Training and Exercise Planning Workshop (TEPW). The
TEPW section provides guidance to organizations in conducting an annual
TEPW and developing a Multi-year Training and Exercise Plan (TEP) in
line with the HSEEP (https://www.fema.gov/sites/default/files/2020-04/Homeland-Security-Exercise-and-Evaluation-Program-Doctrine-2020-Revision-2-2-25.pdf).
We propose at Sec. 485.542(d)(2) to require that the REH conduct
exercises to test the emergency plan at least annually. Specifically,
we propose to require that the REH conduct two testing exercises, a
full-scale or functional exercise and an additional exercise of its
choice, every 2 years. First, the REH must participate in a full-scale
exercise that is community-based. When a community-based exercise is
not accessible, we propose that the REH
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must conduct a facility-based functional exercise or if the REH
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the REH is exempt from engaging in
its next required community-based or individual, facility-based
functional exercise following the onset of the emergency event. Second,
the REH must conduct an additional exercise, opposite the year the
full-scale or functional exercise is conducted, that may include, but
is not limited to a second full-scale exercise that is community-based,
or an individual, facility-based functional exercise, a mock disaster
drill, or a tabletop exercise or workshop that is led by a facilitator
and includes a group discussion using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan. Lastly,
we propose to require that the REH must analyze its response to and
maintain documentation of all drills, tabletop exercises, and emergency
events and revise the REH's emergency plan, as needed.
We propose at Sec. 485.625(e)(1)(i) that REHs must store emergency
fuel and associated equipment and systems as required by the 2000
edition of the Life Safety Code (LSC) of the NFPA[supreg]. In addition
to the emergency power system inspection and testing requirements found
in NFPA[supreg] 99 and NFPA[supreg] 110 and NFPA[supreg] 101, we
proposed that REHs test their emergency and stand-by-power systems for
a minimum of 4 continuous hours every 12 months at 100 percent of the
power load the REH anticipates it will require during an emergency.
Finally, at Sec. 485.542(f), we propose to specify that if an REH
is part of a healthcare system consisting of multiple separately
certified healthcare facilities that elects to have a unified and
integrated emergency preparedness program, the REH may choose to
participate in the healthcare system's coordinated emergency
preparedness program. If elected, we propose that the unified and
integrated emergency preparedness program must demonstrate that each
separately certified facility within the system actively participated
in the development of the unified and integrated emergency preparedness
program and be developed and maintained in a manner that takes into
account each separately certified facility's unique circumstances,
patient populations, and services offered.
In addition, we propose that each separately certified REH in the
system must be capable of actively using the unified and integrated
emergency preparedness program and is in compliance. We also propose
that the unified and integrated emergency preparedness program must
include a unified and integrated emergency plan that is based on a
documented community-based risk assessment, utilizing an all-hazards
approach and a documented individual facility-based risk assessment for
each separately certified REH within the health system, utilizing an
all-hazards approach. Lastly, we propose that the unified and
integrated emergency preparedness program must have integrated policies
and procedures, a coordinated communication plan, and training and
testing programs.
22. Condition of Participation: Physical Environment (Proposed Sec.
485.544)
The LSC is a compilation of fire safety requirements for new and
existing buildings, and is updated and published every 3 years by the
National Fire Protection Association (NFPA), a private, nonprofit
organization dedicated to reducing loss of life due to fire. The
Medicare and Medicaid regulations have historically incorporated these
requirements by reference, along with Secretarial waiver authority. The
statutory basis for incorporating NFPA's LSC into the regulations we
apply to Medicare and, as applicable, Medicaid providers and suppliers
is the Secretary's facility-specific authority to stipulate health and
safety regulations for each type of Medicare and (if applicable)
Medicaid-participating facility. For REHs, that statutory authority is
set out at new section 1861(kkk)(2)(D)(v) of the Act. The following
provisions we have proposed are similar to the Hospital, CAH, and ASC
LSC and Health Care Facilities Code requirements.
The 2012 Edition of the Life Safety Code
As stated previously, the LSC is a compilation of fire safety
requirements for new and existing buildings, and is updated and
published every 3 years by the NFPA. The NFPA 101[supreg]2012 edition
of the LSC (including the technical interim amendments (TIAs)) provides
minimum requirements, with due regard to function, for the design,
operation and maintenance of buildings and structures for safety to
life from fire. Its provisions also aid life safety in similar
emergencies. The NFPA 99[supreg] 2012 edition of the Health Care
Facilities Code (including the TIAs) provides minimum requirements for
health care facilities for the installation, inspection, testing,
maintenance, performance, and safe practices for facilities, material,
equipment, and appliances, including other hazards associated with the
primary hazards.
We review each new edition of the NFPA 101 and NFPA 99 every 3
years to see if there are any significant provisions that we need to
adopt, but there is no requirement to use the most recent version. We
will continue to review these documents every 3 years to see if there
are relevant or updated provisions that we need to adopt. The 2012
edition of the LSC includes provisions that we believe are vital to the
health and safety of all patients and staff. Our intention is to ensure
that patients and staff continue to experience the highest degree of
fire safety possible. All Medicare and Medicaid participating providers
and suppliers are currently subject to the requirements of the 2012
edition of the LSC and the 2012 edition of the Health Care Facilities
Code as adopted by CMS.
Therefore, in this rule we propose to incorporate by reference the
NFPA 101[supreg] 2012 edition of the LSC, issued August 11, 2011, and
all Technical Interim Amendments issued (TIA) April 16, 2014; and the
NFPA 99[supreg]2012 edition of the Health Care Facilities Code, issued
August 11, 2011, and all TIA issued prior to April 16, 2014. (1) NFPA
101, LSC, 2012 edition, issued August 11, 2011; (i) TIA 12-1 to NFPA
101, issued August 11, 2011. (ii) TIA 12-2 to NFPA 101, issued October
30, 2012. (iii) TIA 12-3 to NFPA 101, issued October 22, 2013. (iv) TIA
12-4 to NFPA 101, issued October 22, 2013. (2) NFPA 99, Standards for
Health Care Facilities Code of the NFPA 99, 2012 edition, issued August
11, 2011. (i) TIA 12-2 to NFPA 99, issued August 11, 2011. (ii) TIA 12-
3 to NFPA 99, issued August 9, 2012. (iii) TIA 12-4 to NFPA 99, issued
March 7, 2013. (iv) TIA 12-5 to NFPA 99, issued August 1, 2013. (v) TIA
12-6 to NFPA 99, issued March 3, 2014. The materials that are
incorporated by reference are available to interested parties and can
be inspected at the CMS Information Resource Center, 7500 Security
Boulevard, Baltimore, MD. Copies may be obtained from the National Fire
Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
www.nfpa.org, 1 (617) 770-3000. If any changes in this edition of the
Code are incorporated by reference, CMS will publish a document in the
Federal Register to announce the changes.
The 2012 Edition of the Health Care Facilities Code
The 2012 edition of the NFPA 99, ``Health Care Facilities Code,''
addresses requirements for both health care occupancies and ambulatory
care occupancies and serves as a resource for
[[Page 40372]]
those who are responsible for protecting health care facilities from
fire and associated hazards. The purpose of this Code is to provide
minimum requirements for the installation, inspection, testing,
maintenance, performance, and safe practices for health care facility
materials, equipment and appliances. This Code is a compilation of
documents that have been developed over a 40-year period by NFPA, and
is intended to be used by those persons involved in the design,
construction, inspection, and operation of health care facilities, and
in the design, manufacture, and testing of appliances and equipment
used in patient care areas of health care facilities. It provides
information on subjects, for example, medical gas and vacuum systems,
electrical systems, electrical equipment, and gas equipment. The NFPA
99 applies specific requirements in accordance with the results of a
risk-based assessment methodology. A risk-based approach allows for the
application of requirements based upon the types of treatment and
services being provided to patients or residents rather than the type
of facility in which they are being performed. In order to ensure the
minimum level of protection afforded by NFPA 99 is applicable to all
patient and resident care areas within a health care facility, we are
proposing to adopt the 2012 edition of NFPA 99, with the exception of
chapters 7--Information Technology and Communications Systems for
Health Care Facilities; 8--Plumbing; 12--Emergency Management; and 13--
Security Management.
REH Proposed Requirements
At Sec. 485.544(a) we propose that the REH be constructed,
arranged, and maintained to ensure the safety of the patient and to
provide facilities for diagnosis and treatment and for special hospital
services appropriate to the needs of the community. Specifically, we
propose that the condition of the physical plant and the overall REH
environment must be developed and maintained in such a manner that the
safety and well-being of patients are assured. This would include
emergency power and lighting in at least all areas serviced by the
emergency supply source, including but not limited to, the operating,
recovery, and emergency rooms, and stairwells. In all other areas not
serviced by the emergency supply source the REH would be required to
have battery lamps and flashlights available. In addition, we propose
to require the REH to have facilities for emergency gas and water
supply and a safe and sanitary environment, that is properly
constructed, equipped and maintained to protect the health and safety
of all patients.
At Sec. 485.544(b), we propose that the REH be required to
maintain adequate facilities for its services that includes diagnostic
and therapeutic facilities that are located in a manner that ensures
the safety of patients. We also would require the REH to maintain
facilities, supplies, and equipment in a manner that ensures an
acceptable level of safety and quality. We propose further that the
facility be designed and maintained to reflect the scope and complexity
of the services it offers in accordance with accepted standards of
practice and that there must be proper ventilation, light, and
temperature controls in pharmaceutical, food preparation, and other
appropriate areas.
At Sec. 485.544(c), we propose that REHs meet the provisions
applicable to Ambulatory Health Care Occupancies in the 2012 edition of
the LSC, regardless of the number of patients the facility serves. We
believe the protection provided in the Ambulatory Health Care
Occupancies chapter is necessary to protect the health and safety of
patients who are incapable of caring for themselves at any point in
time. We propose at Sec. 485.544(c)(2) to implement requirements
related to the Secretary's waiver authority for periods deemed
appropriate, which would result in unreasonable hardship, but only if
the waiver will not adversely affect the health and safety of patients.
We propose at Sec. 485.544(c)(3) that the provisions of the LSC would
not apply in a state if CMS finds that a fire and safety code imposed
by state law adequately protects patients. We also propose at Sec.
485.544(c)(4) requirements related to protection against inappropriate
access for alcohol-based hand rub dispensers. At Sec. 485.544(c)(5),
we propose to require that a REH with a sprinkler system that is out of
service for more than 10 hours in a 24-hour period to evacuate the
building or portion of the building affected by the system outage, or
establish a fire watch until the system is back in service,
notwithstanding the lower standard of the 2012 LSC.
Lastly, at Sec. 485.544(d) we propose to require REHs to comply
with the 2012 edition of the NFPA 99. We propose that chapters 7, 8,
12, and 13 would not apply to REHs. We also propose to allow for
waivers of these provisions under the same conditions and procedures
that we currently use for waivers of applicable provisions of the LSC.
23. Condition of Participation: Skilled Nursing Facility Distinct Part
Unit (Proposed Sec. 485.546)
Section 1861(kkk)(2)(D)(vi) of the Act allows REHs to establish a
unit that is a distinct part licensed as a SNF to furnish post-REH or
post-hospital (in the event the services were provided at a hospital or
a CAH) extended care services (or SNF services). A distinct part SNF is
an area that is separately licensed and certified to provide SNF
services at all times. A distinct part SNF must be physically
distinguishable from the REH, must be fiscally separate for cost
reporting purposes, and the beds in the certified distinct part SNF
unit of an REH must meet the requirements applicable to distinct part
SNFs at 42 CFR part 483, subpart B. Medicare payment for SNF services
furnished in these distinct part SNFs of an REH would be under the SNF
prospective payment system as required under section 1834(x)(4) of the
Act. We note that a distinct part SNF of an REH is not subject to the
REH's length of stay limits of less than an annual per patient average
of 24 hours.
According to a policy brief published by RUPRI Center for Rural
Health Policy Analysis, there were 472 nursing home closures between
2008 and 2018 in nonmetropolitan counties in the U.S.\28\ The policy
brief noted that 10.1 percent of the country's nonmetropolitan counties
had no nursing homes. Given the closures of rural nursing homes and the
lack of nursing homes in rural communities, residents living in rural
areas may not have adequate access to SNF services. The provision of
these services in distinct part units of REHs may help address this
access issue.
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\28\ RUPRI Center for Rural Health Policy Analysis. (2021).
Trends in Nursing Home Closures in Nonmetropolitan and Metropolitan
Counties in the United States, 2008-2018. https://rupri.public-health.uiowa.edu/publications/policybriefs/2021/Rural%20NH%20Closure.pdf.
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We highlight that a distinct part SNF unit is not the same as a CAH
or hospital utilizing swing-beds. CAHs and hospitals may provide swing-
bed services, allowing them to use their beds for acute inpatient care
or for post-hospital or CAH SNF care. These facilities must be
certified by CMS to provide swing-bed services. CAHs or hospitals
utilizing swing-beds are not required to have their swing-beds in a
special unit or area within the facility.
To implement that statutory provision allowing REHs to establish
distinct part SNFs, we are proposing at Sec. 485.546 to require REHs
choosing to establish such a distinct part unit to meet the
[[Page 40373]]
requirements for long-term care facilities at 42 CFR part 483, subpart
B.
B. Proposed Changes for Critical Access Hospital Conditions of
Participation
1. Condition of Participation: Status and Location (Sec. 485.610(c))
a. Adding the Definition of ``Primary Roads''
Generally, a CAH must meet certain criteria for designation, as
outlined in section 1820(c)(2)(B) of the Act. These criteria specify
certain ``distance requirements'' relative to other hospitals or CAHs,
and specifically require that a CAH be (1) ``located more than a 35-
mile drive (or, in the case of mountainous terrain or in areas with
only secondary roads available, a 15-mile drive) from a hospital'' or
(2) ``certified before January 1, 2006, by the State as being a
necessary provider of health care services to residents in the area''.
The current regulatory requirement at Sec. 485.610(c) sets forth the
distance requirements for CAHs relative to other CAHs and hospitals,
and specific definitions as related to the distance requirements are
found in the SOM, Chapter 2, Section 2256A.
In 2013, the HHS OIG released a report entitled Most Critical
Access Hospitals Would Not Meet the Location Requirements If Required
to Re-Enroll in Medicare (OEI-05-12-00080) which found that
approximately 63 percent of CAHs would not meet the distance
requirement if required to re-enroll in Medicare. The report also found
that CMS does not have the authority to decertify most of these CAHs
based on failure to meet the distance requirement, as a majority of
these CAHs are ``necessary provider'' CAHs and therefore exempt from
the distance requirement as noted in section 1820(h)(3) of the Act. The
report also included a recommendation for CMS to ensure that CAHs'
compliance with the location-related CoPs is periodically reassessed.
In response, CMS began evaluating its policies concerning the
definitions of several key concepts used in enforcing the CAH
regulations at Sec. 485.610, which are further described in the SOM,
Chapter 2, Section 2256A for enforcement of the distance requirements.
The COVID-19 PHE put a hold on CAH certifications, and CMS has used
this opportunity to work with interested parties to continue to review
how it applies the distance requirements for CAH eligibility. In this
proposed rule, CMS outlines how it will apply the CAH distance
requirements as a result of its review. We recognize the impact of
these criteria on rural communities and we aim to minimize any
disruption to CAHs based on these requirements.
The distance requirements are uniquely important to CAH
designations, as they must continually be met to maintain status as a
CAH, by statutory design. As such, CMS anticipates certain facilities
may lose or gain eligibility for CAH designation depending on the
locations of hospitals and CAHs established within relevant distance of
the CAH. Thus, CMS must continually verify the CAH distance
requirements periodically to ensure that they are still met. CMS
generally recertifies the distance requirements of CAHs every three
years or upon a change of ownership as a component of initial
certification or a recertification. If there is a change in distance
and location that does not meet the requirements, CMS notifies the
provider of its options for continued enrollment in the Medicare
program.
CMS publishes guidance related to the distance requirements in the
SOM, Chapter 2, Section 2256A. One of the distance criteria, as
described in section 1820(c)(2)(B)(i) of the Act and set forth in Sec.
485. 610(c), requires CMS to determine what constitutes a secondary
road, and by extension a primary road. In 2015, CMS refined the
definition of ``primary road'' in the SOM. The purpose of this
refinement was, first, to make the definition of what constitutes a
``primary road'' more consistent across regions of the U.S., and,
second, to make measuring the distances between facilities more
consistent. It was not anticipated that this refinement in the
definition of primary road would have any significant impact on the
eligibility of existing CAHs to maintain their certification, but
certain providers and interested parties raised concern in anticipation
of their re-certification. Specifically, they were concerned about
certain aspects of the 2015 refinements from the previous SOM update
that would no longer afford them eligibility as a CAH, even though the
existing CAH did not change location and there were no other CAHs or
hospitals that moved within a relevant distance. Thus, CMS is further
refining and codifying the definition to offer maximum flexibility to
providers in meeting these distance criteria.
Presently, primary roads are defined as any U.S. highway,
including; (1) any road in the National Highway System, as codified at
23 U.S.C. 103(b); or (2) in the Interstate System, as defined at 23
U.S.C. 103(c); or (3) which is a US-Numbered Highway (also called ``US
Routes'' or ``US Highways'') as designated by the American Association
of the State Highway and Transportation Officials (AASHTO), regardless
of whether it is also part of the National Highway System. Currently,
there is no regulatory language that references primary roads or
outlines the definition of this term.
We propose to incorporate the definition of primary road in the CAH
distance requirement regulations, both as part of the 35-mile drive
requirement, and as applicable through the secondary roads definition
for the 15-mile drive requirement. Specifically, we propose to revise
Sec. 485.610(c) to clarify that the location distance for a CAH is one
for more than a 35-mile drive on primary roads (or, in the case of
mountainous terrain or in areas with only secondary roads available, a
15-mile drive) from a hospital or another CAH. In addition, at Sec.
485.610(c)(2), we propose to specify that primary road of travel for
determining the driving distance of a CAH and its proximity to other
providers as a numbered Federal highway, including interstates,
intrastates, expressways or any other numbered Federal highway; or a
numbered state highway with two or more lanes each way. We are also
soliciting comments regarding the description of a numbered Federal
highway in this proposed definition. Specifically, we are interested in
feedback on whether the definition of primary roads should include
numbered Federal highways with two or more lanes, similar to the
description of numbered state highways, and exclude numbered Federal
highways with only one lane in each direction.
We believe that codifying the definition of primary roads in the
regulations will provide clarity and consistency regarding the distance
requirements.
Furthermore, if finalized, to support these proposed regulatory
changes we are planning to establish a centralized, data-driven review
procedure that focuses on hospitals being certified in proximity to a
CAH, rather than focusing specifically on road classifications. CMS
would review all hospitals and CAHs within a 50-mile radius of the CAH
during each review of eligibility, and then subsequently on a 3-year
cycle. Following the initial review of distance and location, further
investigations would focus primarily on expanded healthcare capacity
and access to care within the 35-mile radius of the CAH being examined
and less on the actual roadway designations used in making the
calculations. Those CAHs with no new hospitals within 50 miles would be
immediately recertified. Those CAHs with new hospitals within 50 miles
will receive additional review
[[Page 40374]]
based on the distance from the new hospital and the definitions for
Primary Roads and Mountainous Terrain. To facilitate this review, the
CAH Distance Analysis Committee and the CMS Survey Operations Group
(SOG) Locations will utilize the geocoding of hospitals to identify
those CAHs that are located within 50 miles of another certified
hospital. Those CAHs that do not meet the regulatory distance and
location requirements at the time of review would be identified as non-
compliant and may face enforcement actions. We believe this change
would help surveyors to make evidence-based and objective
determinations of continued CAH eligibility. We expect the new distance
review procedure, coupled with regulatory clarity on the proposed
primary roads definition, would provide greater consistency in
evaluating if CAHs meet the statutory 35 or 15-mile distance
requirements from other acute care hospitals and CAHs as well greater
adherence to statutory language by ensuring that CAHs operate under the
CAH designation until, or unless, a hospital moves within 35 miles or
15 miles of the existing CAH.
2. Condition of Participation: Patient's Rights (Sec. 485.614)
We believe that it is imperative for patients to have the ability
to exercise certain rights and protections while seeking and receiving
necessary care and services at a CAH. Ensuring that patients and family
members are aware of their rights and how to exercise them are vital
components of improving overall CAH quality and patient satisfaction.
We believe that having patient's rights requirements for CAHs creates
transparency between the provider and patient. In addition, adding
patient's rights requirements for CAHs is consistent with other
providers and suppliers similar to CAHs, including those proposed in
this rule for REHs. As previously mentioned, behavioral health is very
important in the treatment and safety of patients and staff. Behavioral
health is a challenge in rural areas, due to the accessibility,
affordability, acceptability and availability of these services,
therefore we believe it is important to have policies and procedures in
place for CAHs and REHs in the event of a mental health crisis and the
need for the use of restraints and seclusions.
We have received feedback from interested parties stating that CAHs
should have patient rights requirements in place to protect the
patient. Therefore, we are mirroring these proposed requirements for
CAHs after the hospital patient's rights requirements found at Sec.
482.13. However, we note that some of the provisions in this section
for CAHs, and also for REHs (as discussed earlier) have requirements
that are less prescriptive than those for hospitals because are
proposing to allow for these providers to develop policies and
procedures based on the scope of services they provide and patient
populations they serve.
For example, we believe that CAHs will have a lower volume of
patients than hospitals and the use of restraints and seclusion would
not be as frequent as other providers. CAHs do not currently have any
patient rights CoPs so our proposed requirements aim to increase
accountability and provide patient protections in the event restraints
and seclusion are used. We are specifically soliciting comments on the
appropriateness of the patient's rights requirements proposed for
restraint and seclusion, the potential need to require standards that
are more stringent to address patient protections, and the feasibility
of implementing such requirements in rural communities.
Specifically, we propose to establish a CoP for patient's rights at
Sec. 485.614 that would set forth the rights of all patients to
receive care in a safe setting and provide protection for a patient's
emotional health and safety as well as their physical safety. This
would include proposed requirements for the CAH to inform patients of
and exercise their rights; address privacy and safety; adhere to the
confidentiality of patient records; responsibilities for the use of
restraint and seclusion; and adherence to patient visitation rights.
Notice of Rights
At Sec. 485.614(a), we propose that a CAH must inform each
patient, or when appropriate, the patient's representative (as allowed
under state law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible. This includes a proposal
to require the CAH to establish a process for the oversight and prompt
resolution of patient grievances and for informing each patient whom to
contact to file a grievance.
Exercise of Rights
At Sec. 485.614(b), we propose to specify those rights a patient
has regarding their medical care, which includes the right to
participate in the development and implementation of their plan of
care, to make informed decisions regarding their care, to be fully
informed about such care, and the right to request or refuse treatment,
and finally the right to have a family member or representative of
their choice and their own physician notified promptly of their
admission to the hospital. We note that this right must not be
construed as a mechanism to demand the provision of treatment or
services deemed medically unnecessary or inappropriate. In addition, we
propose to specify that the patient also has the right to formulate
advance directives and to have CAH staff and practitioners who provide
care in the CAH comply with these directives.
Privacy, Safety, and Confidentiality of Patient Records
At Sec. 485.614(c), we propose to specify that the patient has the
right to personal privacy, receive care in a safe setting, and be free
from all forms of abuse or harassment. At Sec. 485.614(d), we propose
to specify that patients have the right to the confidentiality of their
medical records and the right to access their medical records. When
requested, we propose that the CAH must provide the patients with their
records in a form and format requested by the requestor and within a
reasonable timeframe, as not to frustrate the legitimate efforts of
individuals to gain access to their own medical records.
Use of Restraints and Seclusion
At Sec. 485.614(e), we propose those patient's rights relating to
the use of restraints and seclusion. We are proposing requirements that
are less burdensome than those existing restraint and seclusion
requirements for hospitals because given the level of services provided
by CAHs and their patient volume, we expect the likelihood of their
need to utilize restraints and seclusion to be relatively low.
Specifically, we propose to specify that all patients have the
right to be free from physical or mental abuse, and from corporal
punishment and from restraint or seclusion, of any form, imposed as a
means of coercion, discipline, convenience, or retaliation by staff. We
propose that restraint or seclusion may only be imposed to ensure the
immediate physical safety of the patient, a staff member, or others and
must be discontinued at the earliest possible time. We propose to
define restraint as any manual method, physical or mechanical device,
material, or equipment that immobilizes or reduces the ability of a
patient to move their arms, legs, body, or head freely; or a drug or
medication when it is used as a restriction to manage the patient's
behavior or restrict the patient's freedom of movement and is not a
standard treatment or dosage for the patient's condition. A restraint
does not include devices, such as orthopedically
[[Page 40375]]
prescribed devices, surgical dressings or bandages, protective helmets,
or other methods that involve the physical holding of a patient for the
purpose of conducting routine physical examinations or tests, or to
protect the patient from falling out of bed, off of a stretcher, or out
of a chair, or to permit the patient to participate in activities
without the risk of physical harm (this does not include a physical
escort). We propose to define seclusion as the involuntary confinement
of a patient alone in a room or area from which the patient is
physically prevented from leaving. Seclusion may only be used for the
management of violent or self-destructive behavior.
At Sec. 485.614(e)(2), we propose to require that the restraint or
seclusion may only be used when less restrictive interventions have
been determined to be ineffective to protect the patient a staff member
or others from harm, and at Sec. 485.614(e)(3) that the type or
technique of restraint or seclusion used must be the least restrictive
intervention that will be effective to protect the patient, a staff
member, or others from harm. At Sec. 485.614(e)(4) we propose that the
CAH must have written policies and procedures regarding the use of
restraint and seclusion that are consistent with current standards of
practice. These proposed requirements would allow for the CAH to use
restraints and seclusion in the event that it is necessary and as a
last resort to respond to immediate safety concerns, but lessens the
burden and allows for more flexibility than the current hospital CoPs.
We believe that allowing the CAH the flexibility to develop their own
policies and procedures for restraints and seclusion based on the scope
of services they provide is necessary given their patient volumes,
populations, and access to resources. The policies and procedures that
are developed need to be consistent with current standards of practice.
As noted, we are soliciting comments on the appropriateness of the
patient's rights requirements proposed for restraint and seclusion, the
potential need to require standards that are more stringent to address
patient protections, and the feasibility of implementing such
requirements in rural communities.
Staff Training Requirements for the Use of Restraints or Seclusion
The following staff training requirements are not as prescriptive
as the existing hospital requirements, and we are proposing these same
requirements for REHs in this rule. At Sec. 485.614(f) we propose to
establish staff training requirements for the use of restraints and
seclusion. Specifically, we propose that the patient has the right to
safe implementation of restraint or seclusion by trained staff. We
propose that the CAH must provide competency-based training and
education of CAH personnel and staff, including medical staff, and, as
applicable, personnel providing contracted services in the CAH, on the
use of restraint and seclusion. To ensure that the use of restraint and
seclusion for patients receiving services in a CAH is respectful of,
and responsive to, individual patient preferences, needs and values, we
propose to require that the training be patient-centered. Additionally,
to ensure that staff are educated and trained on using the least
restrictive intervention necessary for the safety of the patients and
CAH staff, we propose at Sec. 485.614(f)(2) to require that the CAH
train their staff in alternatives to the use of restraint and
seclusion. For example, we believe that staff should have trauma-
informed knowledge competencies and be aware of effective de-escalation
techniques that can be used to avoid the use of restraint and seclusion
so not to trigger any previous mental health issues because of the use
of restraints and seclusion. Trained peer workers (people who share
similar experiences of being diagnosed with mental health conditions,
substance use disorders, or both) and CHWs may also serve a useful role
in assisting patients and other staff. This could include helping to
monitor use of restraint and seclusion, deescalating interactions with
patients and contributing to a positive and supportive environment for
patients, family members, and CAH staff. CAHs are encouraged to
consider the use of peer workers and CHWs in their staffing plans. For
further information, please see the 2007 guidance on use of peers in
the Medicaid program (https://www.medicaid.gov/federal-policy-guidance/downloads/SMD081507A.pdf) and resources from the Substance Abuse and
Mental Health Services Administration (https://www.samhsa.gov/brss-tacs/recovery-support-tools/peers). In addition, facilities are
encouraged to consider any nutritional needs while a patient is
restrained, such as a need to provide food and water.
Death Reporting Requirements
The following requirements are similar to the hospital requirements
at Sec. 482.13. At Sec. 485.614(g), we propose to establish
requirements that CAHs must follow when reporting deaths associated
with the use of seclusion or restraint. Specifically, we propose to
require that the CAH must report to CMS, by telephone, facsimile, or
electronically, as determined by CMS, no later than the close of
business on the next business day the following information-- (1) Each
death that occurs while a patient is in restraint or seclusion; (2)
Each death that occurs within 24 hours after the patient has been
removed from restraint or seclusion; (3) Each death known to the CAH
that occurs within 1 week after restraint or seclusion where it is
reasonable to assume that use of restraint or placement in seclusion
contributed directly or indirectly to a patient's death, regardless of
the type(s) of restraint used on the patient during this time. We note
that ``reasonable to assume'' in this context would include, but is not
limited to, deaths related to restrictions of movement for prolonged
periods of time, or death related to chest compression, restriction of
breathing, or asphyxiation.
For instances when no seclusion has been used and when the only
restraints used on the patient are those applied exclusively to the
patient's wrist(s), and which are composed solely of soft, non-rigid,
cloth-like materials, the CAH staff must record in an internal log or
other system, the following information--(1) Any death that occurs
while a patient is in such restraints; (2) Any death that occurs within
24 hours after a patient has been removed from such restraints.
Furthermore, we propose that staff must also document in the patient's
medical record the date and time the death was reported to CMS or
recorded in the internal log or other system. Also, for instances when
no seclusion has been used and when the only restraints used on the
patient are those applied exclusively to the patient's wrist(s),we
propose to require that entries into the internal log or other system
must be documented no later than seven days after the date of death of
the patient, include the patient's name, date of birth, date of death,
name of attending physician or other licensed practitioner who is
responsible for the care of the patient, medical record number, and
primary diagnosis(es), and to be made available in either written or
electronic form to CMS immediately upon request.
Patient Visitation Rights
We propose to redesignate Sec. 485.635(f) as Sec. 485.614(h). At
Sec. 485.614(h), we propose to establish requirements related to a
patient's visitation rights. Specifically, we propose to require that a
CAH must have written policies and procedures regarding the visitation
rights of patients, including those setting forth any clinically
necessary or reasonable restriction or limitation that the CAH
[[Page 40376]]
may need to place on such rights and the reasons for the clinical
restriction or limitation. A CAH must inform each patient (or support
person, where appropriate) of their visitation rights, including any
clinical restriction or limitation on such rights, when they are
informed of their other rights, inform each patient (or support person,
where appropriate) of the right, subject to their consent, to receive
the visitors whom they designates, including, but not limited to, a
spouse, a domestic partner (including a same-sex domestic partner),
another family member, or a friend, and their right to withdraw or deny
such consent at any time, not restrict, limit, or otherwise deny
visitation privileges on the basis of race, color, national origin,
religion, sex, gender identity, sexual orientation, or disability, and
ensure that all visitors enjoy full and equal visitation privileges
consistent with patient preferences.
3. Condition of Participation: Staffing and Staff Responsibilities
(Sec. 485.631)
Unified and Integrated Medical Staff for a CAH in a Multi-Facility
System
In alignment the current standards for hospitals, we are proposing
at Sec. 485.631(e) to allow for either a unique medical staff for each
CAH or for a unified and integrated medical staff shared by multiple
hospitals, CAHs, and REHs within a health care system. We propose to
hold a CAH responsible for showing that it actively addresses its use
of a system unified and integrated medical staff model. We are also
proposing to require that the medical staff members holding privileges
at each separately certified CAH in the system have voted either to
participate in a unified and integrated medical staff structure or to
opt out of such a structure, and to maintain a CAH-specific separate
and distinct medical staff for their respective CAH.
In addition, we propose to require that the unified and integrated
medical staff has bylaws, rules, and requirements that describe its
processes for self-governance, appointment, credentialing, privileging,
and oversight, as well as its peer review policies and due process
rights guarantees, and which include a process for the members of the
medical staff of each separately certified CAH (that is, all medical
staff members who hold specific privileges to practice at that CAH) to
be advised of their rights to opt out of the unified and integrated
medical staff structure after a majority vote by the members to
maintain a separate and distinct medical staff for their CAH. We
propose that the unified and integrated medical staff must be
established in a manner that takes into account each CAH's unique
circumstances, and any significant differences in patient populations
and services offered in each CAH. Lastly, we propose that the unified
and integrated medical staff give due consideration to the needs and
concerns of members of the medical staff, regardless of practice or
location, and the CAH has mechanisms in place to ensure that issues
localized to particular CAHs are duly considered and addressed.
In proposing this allowance for CAHs in the requirements here, we
considered this past rulemaking experience with those multi-hospital
systems using the single governing body and unified and integrated
medical staff model for separately certified hospitals within their
systems, as well as our decision to also propose this flexibility for
REHs (as discussed in section II.A.7. of this rule), and applied the
same model to CAHs within single governing body systems. As we continue
to do with hospitals, we believe that it is in the best interest of
CAHs, medical staff members, and patients to propose this requirement
allowing for the use of a unified and integrated medical staff for a
multi-facility system and its member CAHs, in order to enable the
medical staff of each CAH to voluntarily integrate itself into a larger
system medical staff. We welcome comments on the proposed applicability
of these changes for CAHs.
4. Condition of Participation: Infection Prevention and Control and
Antibiotic Stewardship Programs (Sec. 485.640)
Unified and Integrated Infection Prevention and Control and Antibiotic
Stewardship Programs for a CAH in a Multi-Facility System
Similar to a standard in the hospital CoPs, we propose a standard
at Sec. 485.649(h) for CAHs that would allow for the governing body of
a CAH that is part of a system consisting of multiple separately
certified hospitals, CAHs, and/or REHs using a single system governing
body that is legally responsible for the conduct of two or more
hospitals, CAHs, and/or REHs, to elect to have unified and integrated
infection prevention and control and antibiotic stewardship programs
for all of its member facilities, including any CAHs, after determining
that such a decision is in accordance with all applicable state and
local laws. The system's single governing body would be responsible for
ensuring that each of its separately certified CAHs meets all of the
requirements of this section. We note that each separately certified
CAH subject to the system's single governing body would need to
demonstrate that the unified and integrated infection prevention and
control and antibiotic stewardship programs:
Are established in a manner that takes into account each
member CAH's unique circumstances and any significant differences in
patient populations and services offered in each CAH;
Establish and implement policies and procedures to ensure
that the needs and concerns of each of its separately certified CAHs,
regardless of practice or location, are given due consideration; and
Have mechanisms in place to ensure that issues localized
to particular CAHs are duly considered and addressed.
The CAH would also need to demonstrate that it has designated a
qualified individual (or individuals) with expertise in infection
prevention and control and in antibiotic stewardship at the CAH to be
responsible for:
Communicating with the system's unified infection
prevention and control and antibiotic stewardship programs;
Implementing and maintaining the policies and procedures
governing infection prevention and control and antibiotic stewardship
as directed by the unified infection prevention and control and
antibiotic stewardship programs; and
Providing education and training on the practical
applications of infection prevention and control and antibiotic
stewardship to CAH staff.
5. Condition of Participation: Quality Assessment and Performance
Improvement Program (Sec. 485.641)
Unified and Integrated QAPI Program for a CAH in a Multi-Facility
System
Consistent with the standard included at Sec. 482.21(f) in the
hospital CoPs for QAPI programs, we are proposing at Sec. 485.641(f)
to allow CAHs that are part of a multi-facility system consisting of
multiple separately certified hospitals, CAHs, and/or REHs to elect to
have a unified and integrated QAPI program after determining that such
a decision is in accordance with all applicable state and local laws.
Specifically, we propose to specify that the system's governing body is
responsible and accountable for ensuring that each of its separately
certified CAHs meets the proposed QAPI program requirements. We expect
this allowance, if finalized, would be beneficial to CAHs that may lack
time, resources, or staff to implement a QAPI program. The CAH would be
able to
[[Page 40377]]
benefit from the resources and expertise of a multi-hospital system in
implementing their QAPI program, as well as potentially reducing the
time and labor investments required to enact and maintain the program.
We are interested in input from the public regarding unintended
consequences that could occur as a result of allowing CAHs to
participate in a unified and integrated QAPI program. We are interested
in feedback regarding how the integrated health system's governing body
will ensure that they take into account the CAH's unique circumstances
and any significant differences in patient populations and services
offered at the CAH. We also seek comments regarding how the integrated
health system's governing body will ensure that a CAH participating in
a unified and integrated QAPI program provides the appropriate level of
care to patients being treated in the CAH, including being
appropriately transferred to another facility when necessary.
C. Conforming Amendments and Technical Corrections
1. Technical Correction to Sec. 485.635(b)(2)
We are proposing to make a technical correction to the laboratory
services CAH CoP at Sec. 485.635(b)(2). In the September 1, 1994,
final rule entitled ``Medicare Program; Changes to the Hospital
Inpatient Prospective Payment Systems and Fiscal Year 1995 Rates'' (59
FR 45403), we revised the CAH laboratory services requirement to
require the CAH laboratory services to meet the standards imposed under
section 353 of the Public Health Service Act (42 U.S.C. 236a). We
inadvertently included an error in the referenced Public Health Service
Act standard. The referenced standard at Sec. 485.635(b)(2) should
read, ``. . .353 of the Public Health Service Act (42 U.S.C. 263a).''
2. Conforming Amendments Sec. Sec. 489.2(b) and 489.24(b)
The provider agreement and supplier approval requirements for
Medicare-participating providers and suppliers are located at 42 CFR
part 489. Section 489.2 sets forth the basic requirements for submittal
and acceptance of a provider agreement under Medicare, with the
providers that are subject to the provisions of this part listed at
Sec. 489.2(b). We are proposing to add REHs to the list of applicable
providers at Sec. 489.2(b) and therefore require REHs to adhere to the
requirements for submittal and acceptance of provider agreements under
Medicare as defined by Sec. 489.3.
The requirements at 42 CFR part 489 also set forth requirements for
Medicare hospitals in emergency cases. These provisions apply to
hospitals that have emergency departments. Under this section, a
hospital includes a critical access hospital as defined in section
1861(mm)(1) of the Act. The CAA amends Section 1867(e)(5) of the Act by
including REHs, as defined in 1861(kkk)(2), as hospitals that have
emergency departments. As a result, we are proposing to add REHs to the
definitions at Sec. 489.24(b) for Medicare hospitals in emergency
cases under the hospital definition and to the definition of a
participation hospital.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement (ICR) 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 Paperwork
Reduction Act of 1995 requires that we solicit comment on the following
issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
A. Factors Influencing ICR Burden Estimates
Under this proposed rule, an REH's ICR may differ from that of a
hospital or CAH, given that REHs would be providers of outpatient
services and would not provide inpatient services. We based the ICRs
for REHs on the ICRs for hospitals and CAHs in some cases because, in
accordance with section 1861(kkk) of the Act, REHs must convert from
either a rural hospital with not more than 50 beds or a CAH. In the
discussion that follows, we rely heavily on the study of the North
Carolina Rural Health Research Program's (NC RHRP's) study titled,
``How Many Hospitals Might Convert to a Rural Emergency Hospital
(REH)?'' \29\ This study examined data on existing rural hospitals
(Medicare-funded through both the prospective payment system and cost-
reimbursements to CAHs) to determine how many might meet three key
criteria (1) three years of negative total financial margins; (2)
average daily census of acute and swing beds of less than three
persons; and (3) net patient revenue of less than $20 million annually.
The study further assumed that all the statutory and regulatory
requirements would be met by every REH. The NC RHRP study assumes that
hospitals and CAHs meeting the necessary requirements would apply for
election of coverage under the new REH program. The study did not
address the potential caseload, cost, or revenue changes from electing
conversion and implicitly assumed that the net effects would be
positive.
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\29\ This study can be accessed here: https://www.shepscenter.unc.edu/product/how-many-hospitals-might-convert-to-a-rural-emergency-hospital-reh/.
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We note that another study from consulting firm CLA also examines
the number of facilities likely to convert to REHs titled, ``A Path
Forward: CLA's Simulations on Rural Emergency Hospital Designation.''
\30\ The CLA study estimated that between 11 and 600 CAHs would benefit
from conversion to REH status--based on estimated REH reimbursement and
several financial assumptions (estimated average facility payment,
estimated outpatient fee schedule payment, estimated average skilled
nursing facility payment rates by state, presence or loss of swing bed
payments, and continuance or cessation of 340B eligibility) and four
simulation methods. A key takeaway from both studies is that available
data support a possible wide range of conversion decisions. In
addition, we note that these results and the calculations on which they
rely are subject to a wide range of uncertainty as illustratively shown
in the CLA study's summary estimate and the NC RHRP study makes the
same point in describing its central estimate set of results. In the
analysis that follows, we use for simplicity of exposition the NC RHRP
study results, which depend on data and calculations presented in the
study at a level of detail that allows reader analysis and present our
[[Page 40378]]
summary estimates based on the NC RHRP study's central estimate.
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\30\ CLA, ``A Path Forward: CLA's Simulations on Rural Emergency
Hospital Designation'', 2/8/22, at https://www.claconnect.com/resources/articles/2022/a-path-forward-clas-simulations-on-rural-emergency-hospital-designation.
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In total, the NC RHRP study estimated that there are 1,673
hospitals (mostly CAHs) eligible to convert to an REH and of these, 68
would convert to REH status. The reasons why some would convert are
presented in the NC RHRP study and include low levels of inpatient
revenue, low levels of swing bed nursing care revenue, and negative
financial margins over a period of years.
The finances of individual rural hospitals and CAHs vary widely, as
do the local economic and demographic circumstances of the communities
served by these facilities (for example some rural areas are gaining
population even as most face declining populations). Competition from
other hospitals either in the rural area or in nearby cities also
varies widely, with the only certainty in forecasting REH conversion is
that seemingly similar hospitals and CAHs will make widely different
decisions. What the NC RHRP did, in essence, was predict that the
hospitals and CAHs facing the most severe financial difficulties would
be the most likely to convert.
For purposes of our analysis, we use the NC RHRP estimate of 68
conversions though acknowledge that the number of conversions could be
less than or significantly greater than this estimate. In addition,
when considering the PRA burden for REHs, given that the proposed CoPs
align closely with existing standards, we considered both the existing
burden estimates for CAHs and hospitals, as well as our ongoing
experience with these provider types. We also considered that REHs
would only be furnishing outpatient services, which would lessen their
burden. We request comments on our estimates, particularly the
conversion assumption. The final rule could utilize different estimates
based on these comments.
B. Sources of Data Used in Estimates of Burden Hours and Cost Estimates
For the estimated costs contained in the analysis below, we used
data from the U.S. Bureau of Labor Statistics (BLS) to determine the
mean hourly wage for the positions used in this analysis.\31\ For the
total hourly cost, we doubled the mean hourly wage for a 100 percent
increase to cover overhead and fringe benefits, according to standard
HHS estimating procedures. If the total cost after doubling resulted in
0.50 or more, the cost was rounded up to the next dollar. If it was
0.49 or below, the total cost was rounded down to the next dollar. The
total costs used in this analysis are indicated in Table 1.
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\31\ BLS. May 2020 National Occupational Employment and Wage
Estimates United States. United States Department of Labor. Accessed
at https://www.bls.gov/oes/current/oes_nat.htm. Accessed on August
25, 2021.
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BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP06JY22.004
[[Page 40379]]
BILLING CODE 4120-01-C
C. Rural Emergency Hospitals
1. ICRs Regarding Condition of Participation: Provision of Services
(Sec. 485.514)
Proposed Sec. 485.514(a) would require REHs to furnish health care
services in accordance with appropriate written policies that are
consistent with applicable state law. In addition, proposed Sec.
485.514(b) would require REHs to develop the policies with the advice
of members of the REH's professional health care staff, while Sec.
485.514(d) would require REHs to conduct a biennial review of all its
policies and procedures. We have not designated any specific process or
format for REHs to use in developing their policies or conducting a
review of their policies because we believe they need the flexibility
to determine how best to accomplish these tasks.
In accordance with the section 1861(kkk)(3) of the Act, REHs must
have been either a CAH or a rural hospital with not more than 50 beds
as of the date of enactment of the CAA, December 27, 2020, to convert
to an REH. We estimate that 68 facilities will convert to an REH and we
believe that they will be developing REH-specific policies that are
based on policies that were utilized when the facility was a rural
hospital or CAH. As a result, we estimate that it would take an REH
approximately 80 hours for administrative and clinical staff to develop
policies. If there are 68 REHs to comply with the policy development
requirement and each REH uses 80 hours to comply: (16 hours for a
physician + 16 hours for an administrator + 16 hours for a mid-level
practitioner + 16 hours for a nurse + 16 hours for a clerical staff
person), then the burden hours are 5,440 (68 REHs x 80 hours). The cost
is $8,800 per REH ($3,360 for a physician (16 hours x $210) + $1,952
for an administrator (16 hours x $122) + $1,616 for a mid-level
practitioner (16 hours x $101) + $1,264 for a nurse (16 hours x $79) +
$608 for a clerical staff person (16 hours x $38)). The total cost is
598,400 (68 REHs x $8,800). We estimate that it would take an REH's
professional personnel 16 hours to review and make changes to policies
and procedures biennially. Therefore, for all 68 REHs to comply with
the policy review requirement it would require an estimated 16 burden
hours biennially, or 8 hours annually (1.5 hours for a physician + 2
hours for an administrator + 1.5 hours for a mid-level practitioner +
1.5 hours for a nurse + 1.5 hours for a clerical staff person). The
burden hours are 544 (8 hours x 68 REHs). The cost per REH is $886
($315 for a physician (1.5 hours x $210) + $244 for an administrator (2
hours x $122) + $151.50 for a mid-level practitioner (1.5 hours x $101)
+ $118.50 for a nurse (1.5 hours x $79) + $57 for a clerical staff
person (1.5 hours x $38)). The total cost is $60,248 ($886 x 68 REHs).
Therefore, the total cost for each REH to comply with these
requirements would be $658,648 annually and 5,984 burden hours.
2. ICRs Regarding Condition of Participation: Infection Prevention and
Control and Antibiotic Stewardship Programs (Sec. 485.526)
COVID-19 and Seasonal Influenza Reporting
Consistent with the recent changes we made to the hospital and CAH
infection control CoPs related to COVID-19 and the declared public
health emergency (PHE), we are proposing to require REHs, after the
conclusion of the current COVID-19 PHE, to report COVID-19 and seasonal
influenza-related reporting. The proposed requirements would apply upon
conclusion of the COVID-19 PHE and would continue until April 30, 2024,
unless the Secretary establishes an earlier ending date. The proposed
data elements align closely with those COVID-19 reporting requirements
for long-term care (LTC) facilities that were finalized on November 9,
2021 (86 FR 62421), and are representative of the guidance provided to
hospitals and CAHs for reporting. Therefore, we do not expect that
these categories of data elements would require REHs to report any
information beyond that which they have already been reporting as
existing rural hospitals or CAHs. Furthermore, similar to the
requirements for LTC facilities, this proposal would also allow for the
scope and frequency of data collection to be reduced and limited
responsive to the evolving clinical and epidemiological circumstances.
Based on our experience with those existing hospitals and CAHs and
the current COVID-19 and related reporting requirements, we believe
that this will primarily be the responsibility of a registered nurse
and we have used this position in this analysis at an average hourly
salary of $79. According to the most recent COVID-19 hospital reporting
guidance (available at https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf), hospitals are reporting COVID-19 and influenza-related
data on a daily basis, with backdating permitted for weekends and
holidays, except psychiatric and rehabilitation hospitals who report
weekly. Some data element reporting fields are inactive for data
collection, and therefore, hospitals can optionally report data for
these fields. The inactive fields and active fields together reflect
what is listed in this proposed rule for COVID-19 and influenza-related
reporting as well as future reporting in the event of a declared PHE,
which we discuss next. We do not expect, nor have we proposed, daily
reporting for COVID-19 or influenza outside of a declared PHE.
If we were to assume a weekly reporting frequency, we would
anticipate that there are reduced cases and fewer data elements (with
no line level patient data) being reported. Based on these assumptions,
we estimate that total annual burden hours for REHs to comply with
these requirements would be 5,304 hours based on weekly reporting of
the required information by 68 REHs x 52 weeks per year and at an
average weekly response time of 1.5 hours for a registered nurse with
an average hourly salary of $79. Therefore, the estimate for total
annual costs for all hospitals and CAHs to comply with the required
reporting provisions weekly would be $419,016 or approximately $6,162
per facility annually. We acknowledge that the data elements and
reporting frequency could increase or decrease over the next two years,
and those changes would impact this burden estimate.
We note that this estimate is assumed to be a one-day snapshot of
reporting information as opposed to a cumulative weekly report
accounting for information based on each day of that week. If we
assumed a cumulative weekly account, we can assume reduced burden
related to the actual reporting time, but anticipate that the estimate
would be slightly higher to account for the need to track closely to
daily reporting. We also acknowledge that respondents may have to track
and invest in infrastructure in order to timely and accurately report
on the specified frequency. Thus, respondents may face ongoing burdens
associated with this collection even in the case of reduced frequency
of submissions. We solicit comment on this potentiality.
Furthermore, we note that this estimate likely overestimates the
costs associated with reporting because it assumes that all REHs will
report manually. Efforts are underway to automate reporting that have
the potential to significantly decrease reporting burden and improve
reliability.
[[Page 40380]]
Future Reporting in the Event of a Future PHE Declaration
In addition, we are proposing to establish reporting requirements
for future PHEs related to epidemics and pandemics by requiring REHs to
electronically report information on Acute Respiratory Illness
(including, but not limited to, Seasonal Influenza Virus, Influenza-
like Illness, and Severe Acute Respiratory Infection), SARS-CoV-2/
COVID-19, and other viral and bacterial pathogens or infectious
diseases of pandemic or epidemic potential only when the Secretary has
declared a PHE directly related to such specific pathogens and
infectious diseases. Specifically, when the Secretary has declared a
PHE, we propose to require REHs to report specific data elements to the
CDC's National Health Safety Network (NHSN), or other CDC-supported
surveillance systems, as determined by the Secretary. The proposed
requirements of this section would apply to local, state, and national
PHEs as declared by the Secretary. Relevant to the declared PHE, the
categories of data elements that this report would include are as
follows: suspected and confirmed infections of the relevant infectious
disease pathogen among patients and staff; total deaths attributed to
the relevant infectious disease pathogen among patients and staff;
personal protective equipment and other relevant supplies in the
facility; capacity and supplies in the facility relevant to the
immediate and long term treatment of the relevant infectious disease
pathogen, such as ventilator and dialysis/continuous renal replacement
therapy capacity and supplies; total REH bed and intensive care unit
bed census, capacity, and capability; staffing shortages; vaccine
administration status of patients and staff for conditions monitored
under this section and where a specific vaccine is applicable; relevant
therapeutic inventories and/or usage; isolation capacity, including
airborne isolation capacity; and key co-morbidities and/or exposure
risk factors of patients being treated for the pathogen or disease of
interest in this section that are captured with interoperable data
standards and elements.
We are also proposing to require that, unless the Secretary
specifies an alternative format by which a REH must report each
applicable infection (confirmed and suspected) and the applicable
vaccination data in a format that provides person-level information, to
include medical record identifier, race, ethnicity, age, sex,
residential county and zip code, and relevant comorbidities for
affected patients, unless the Secretary specifies an alternative format
by which the REH would be required report these data elements. We are
also proposing in this provision to limit any person-level, directly or
potentially individually identifiable, information for affected
patients and staff to items outlined in this section or otherwise
specified by the Secretary. We note that the provided information
obtained in this surveillance system that would permit identification
of any individual or institution is collected with a guarantee that it
will be held in strict confidence, will be used only for the purposes
stated, and will not otherwise be disclosed or released without the
consent of the individual, or the institution in accordance with
sections 304, 306, and 308(d) of the Public Health Service Act (42
U.S.C. 242b, 242k, and 242m(d)). Lastly, we are proposing that a REH
would provide the information specified on a daily basis, unless the
Secretary specifies a lesser frequency, to the Centers for Disease
Control and Prevention's National Healthcare Safety Network (NHSN) or
other CDC-supported surveillance systems as determined by the
Secretary.
For purposes of this burden collection, we acknowledge the unknown
and the ongoing burdens that may exist even if CMS is not collecting
information outside of a declared PHE. We recognize that considerations
such as building and maintaining the infrastructure to support
readiness are necessary to ensure compliance with this requirement.
Therefore, we are soliciting comment on the burden associated with
these proposed requirements given the intended flexibility provided in
reducing or limiting the scope and frequency of reporting based on the
state of the PHE and ongoing circumstances. We are specifically asking
for comment on the potential burden associated with the proposed
reporting requirements as they might relate to any differences in the
public health response to one specific pathogen or infectious disease
versus another that would be directly related to the declared PHE. We
are also interested in public comments addressing burden estimates (and
the potential differences in those estimates) for variations in the
required reporting response for a local PHE versus a regional PHE
versus a national PHE that might be declared by the Secretary based on
the specific circumstances at the time of the declaration.
CMS will pursue an emergency collection of information in the case
of a declared PHE and use such burden estimate to inform its approach
at that time. CMS will also publish an accompanying Federal Register
Notice concurrent with its submission of a request to collect
information, in addition to all other actions consistent with 5 CFR
1320.13. CMS commits to ensuring that respondents are well aware in
advance of the intention to collect such information and solicits
comment on the appropriate timeline and notification process for such
actions.
3. ICRs Regarding Condition of Participation: Staffing and Staff
Responsibilities (Sec. 485.528)
We proposed that the emergency department of the REH be staffed 24
hours a day, 7 days a week, and we propose this requirement at Sec.
485.6528(a) and that a doctor of medicine or osteopathy, nurse
practitioner, clinical nurse specialist, or physician assistant must be
available to furnish services in the REH in the facility 24 hours a
day. The burden associated with this requirement is the time it takes
to review the REH's written policies and make appropriate changes or
updates regarding its staffing and staff responsibilities for the
services it furnishes. In conjunction with a mid-level practitioner,
the physician develops, executes, and periodically reviews the REH's
written policies governing the services it furnishes. We estimate that
it will take the physician and mid-level practitioner 1 hour each to
review the REH written policies and make the appropriate changes. We
also estimate that a REH will utilize the services of one clerical
person for half an hour to process any changes or updates, for a total
of 2.5 burden hours and an estimated cost per REH of $ 330 ((1 hour x
$210 for a physician) + (1 hour x $101 for a mid-level practitioner) +
(0.5 hours x $38 for clerical staff)). Therefore, the burden associated
with this requirement is an estimated 170 burden hours (2.5 hours x 68
REHs) at an estimated cost of $22,440 ($330 x 68 REHs).
4. ICRs Regarding Condition of Participation: Patient's Rights (Sec.
485.534) Standard: Notice of Rights: Sec. 485.534(a)(1) and (2)
Proposed Sec. 485.534(a) would require REHs to notify a patient of
their rights and of whom to contact to file a grievance. We allow REHs
the flexibility to use different approaches to meet this CoP. We have
set forth general elements that should be common to all grievance
processes, but have not delineated strategies and policies for
implementing this system. We believe that in large
[[Page 40381]]
measure, REHs would be able to use existing systems for providing
patients with information and handling complaints, and the elements
listed in the regulation only serve to give basic assurance that these
systems are responsive to patient grievances and act effectively. A
less specific approach would permit a nominal, non-functional system
that in essence did not serve the very purpose intended by the
regulation. Costs associated with formalizing a process and modifying
any existing notices or processes will most likely be partially offset
by a reduction in patient-initiated lawsuits regarding care, and should
provide a valuable tool for targeting internal quality assurance
mechanisms.
We asked that the patient be provided with written notice
containing a contact person's name, the steps taken on behalf of the
patient to investigate the grievance, the results of the grievance
process, and the date of completion. Steps taken on behalf of the
patient need not include a detailed description of who was spoken to
and when. It might merely be that the appropriate staff were
interviewed and that records were reviewed to investigate the
grievance, and that the investigation found the grievance to be either
unsubstantiated or substantiated. Second, the figures represented are
estimates. We know of no existing system that tracks how many
complaints are lodged in aggregate in hospitals or CAHs each year;
however, for REHs, we believe that the grievance response can largely
rely on standardized language with only relevant information filled in,
or could be created in a check-sheet format, or in many other ways.
Thus, the burden associated with this requirement is the time and
effort necessary to modify any existing notices to include the proposed
grievance process requirements. We believe that an office assistant may
be tasked with drafting or updating the notices and distributing or
posting, as appropriate, the information. We estimate that this would
require no more than two hours of the clerical staff time. Based on
this we estimate that this will create a one-time cost of $5,168 (68
REHs x 2 hours x $38 clerical staff hourly wage). In addition, we
estimate that it will require the office assistant 2 minutes (.0333
hours) to provide the notice per REH patient on an annual basis. The
number of notices required will depend on the number of patients
received at the REH. Therefore, the per facility burden associated with
providing the notice will vary based on the unique factors of the REH.
According to an OIG report, there were 2,316,675 outpatient visits in
2011 at CAHs.\32\ Based on this estimate, we assume that the REH will
have an average of 1,743 outpatient/emergency department visits per
year that would require informing each patient of their rights which
would take 58 hours (.0333 hours x 1,743 notices). The cost is $149,872
($38 clerical staff wage x 58 hours x 68 REHs).
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\32\ https://oig.hhs.gov/oei/reports/oei-05-12-00081.pdf.
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In its resolution of a grievance, a REH must provide the patient
with written notice of its decision that contains the name of the REH
contact person, the steps taken on behalf of the patient to investigate
the grievance, the results of the grievance process, and the date of
completion.
The burden associated with this requirement is the time and effort
necessary to disclose the written notice to each patient who filed a
grievance. We estimate that on average it will take each REH 15 minutes
to develop and disseminate the required notice and estimate that an REH
may have to provide 50 notices on an annual basis for a total annual
burden. The burden hours would be 13 hours (0.25 hours x 50 notices).
The total burden hours would be 884 hours (13 hours x 68 REHs) at the
cost of $33,592 ($38 x 884 hours). Therefore, the total burden
associated with this requirement is $188,632 ($5,168 to update notices,
$149,872 to provide the notices, and $33,592 to provide the results of
a grievance investigation).
Standard: Confidentiality of Patient Records (Sec. 485.534(d))
Proposed Sec. 485.534(d), which sets forth the patient's right to
access information in their records, will involve minimal burden as
many states' existing laws cover this point. We have not proposed to
require disclosure of all records, inasmuch as we recognize that there
are situations where such a release could be harmful to the patient or
another individual. Furthermore, we have not taken a prescriptive
approach in specifying how quickly this information must be provided to
the patient, or by setting a rate that the REH can charge. In the
absence of state law, the REH should charge whatever is reasonable and
customary in its community for duplication services (based on rates at
local commercial copy centers, post offices, or other venues in which
one could make photocopies). Therefore, while this requirement is
subject to the PRA, we believe that the burden associated with this
requirement is exempt from the PRA, as defined in 5 CFR 1320.3(b)(2)
and (3) because this requirement is considered standard industry
practice and/or is required under state or local law.
Standard: Restraint and Seclusion (Sec. 485.534(e))
Section 485.534(e) requires that REH must have written policies and
procedures regarding the use of restraint and seclusion that are
consistent with current standards of practice. While the requirement is
subject to the PRA, we believe the associated burden is exempt in
accordance with 5 CFR 1320.3(b)(2) because the time, and effort, and
financial resources necessary to comply with this requirement would be
incurred by persons in the normal course of their activities. These are
reasonable and customary state practices based on current standards of
practice and the state would impose this standard for efficient
utilization of Medicare or Medicaid services in the absence of a
Federal requirement. However, we are soliciting comment on whether this
is a customary business practice or whether this would impose an
additional burden on those providers eligible to convert to an REH.
Standard: Restraint and Seclusion: Staff Training Requirements (Sec.
485.534(f))
Section 485.534(f) requires facilities to establish staff training
requirements for the use of restraints and seclusion. The REH must
provide competency-based training and education of REH personnel and
staff, including medical staff, and, as applicable, personnel providing
contracted services in the REH, on the use of restraint and seclusion.
While these information collection requirements are subject to the PRA,
we believe the burden associated with them are exempt as defined in 5
CFR 1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with the requirement are incurred by persons in the
normal course of their activities. However, we are soliciting comment
on whether this is a customary business practice or whether this would
impose an additional burden on those providers eligible to convert to
an REH.
Standard: Death Reporting Requirements (Sec. 485.534(g))
Section 485.534(g) requires the facility to report the death of a
resident associated with restraint or seclusion to the CMS regional
office. A report must include the name of the resident involved in the
serious occurrence, a description of the occurrence, and the name,
street address, and telephone number of the facility.
[[Page 40382]]
We estimate it will take 5 minutes to report each death to the CMS
regional office and to document that report. We estimate fewer than 10
deaths annually for all 68 facilities. Five (5) minutes x 10 deaths
annually would equate to a national burden of 50 minutes per year.
The hourly adjusted rate for a Medical and Health Service Manager
responsible for notifying the CMS regional office of a death a
documenting the report is $122/hour. Multiplying the total burden of
0.83 hours by the hourly wage yields an associated cost of about
$101.67.
Standard: Patient Visitation Rights (Sec. 485.534(h))
Section 485.534(h) requires a REH to have written policies and
procedures regarding the visitation rights of patients, including any
clinically necessary or reasonable restriction or limitation that the
REH may need to place on such rights and the reasons for the clinical
restriction or limitation. Specifically, the written policies and
procedures must contain the information listed in Sec. 485.534(h)(1)
through (4). Given that the statute requires a REH to have been either
a CAH or rural hospital as of the date of enactment of the CAA, we
expect these facilities to already have a visitation policy in
accordance with the CAH and hospital CoPs at Sec. Sec. 485.635(f) and
482.13(h), respectively. Therefore, the ICR burden associated with this
requirement would be the time and effort necessary for a REH to review
and make any necessary updates given its conversion to an REH and to
distribute that information to patients. We expect that an office
secretary or other clerical staff would update and distribute, or post
as appropriate, the information and could accomplish this task in 15
minutes for an estimated one-time burden total of 17 hours (0.25 hours
x 68 REHs) and at the cost of $646 ($38 x 17 hours).
5. ICRs Regarding Condition of Participation: Transfer Agreements
(Proposed Sec. 485.538)
At Sec. 485.538, we propose that each REH must have a transfer
agreement in effect with at least one certified hospital that is a
level I or level II trauma center for the referral and transfer of
patients requiring emergency medical care beyond the capabilities of
the REH. We estimate that it would require an REH administrator and a
clerical person 2 hours each to develop the initial agreement and
obtain the appropriate approvals. According to Table 1, the REH
administrator's total hourly cost is $122 per hour. The clerical staff
person's total hourly cost is $38. We estimate that for each REH to
comply with the requirements in this section it would require 4 burden
hours which would be a total of 272 hours (4 hours x 68 REHs). The cost
is $320 ($244 (2 hours x $122 for an administrator) + $76 (2 hours x
$38 for a clerical staff person)) for each REH. The total cost is
$21,760 ($320 x 68 REHs). This is a one-time cost.
6. ICRs Regarding Condition of Participation: Medical Records (Proposed
Sec. 485.540)
There is no burden attributed to this task. The REH's health care
services are furnished in accordance with appropriate written policies
that are consistent with applicable state law. The policies include a
description of the services the REH furnishes directly and those
furnished through agreement or arrangement; policies and procedures for
emergency medical services and guidelines for medical management of
health problems that include the conditions requiring medical
consultation and/or patient referral and the maintenance of health care
records.
We are not including burden associated with certain patient related
activities such as health care plans, patient records, medical records,
etc., because prudent institutions already incur this burden in the
course of doing everyday business. As stated in 5 CFR 1320.3(b)(2), the
burden associated with usual and customary business practices is exempt
from the PRA. However, we are soliciting comment on whether this is a
customary business practice or whether this would impose an additional
burden on those providers eligible to convert to an REH. Further, state
laws require providers to maintain patient records. (For example, the
annotated Code of Maryland (] 10.11.03.13) requires a provider to be
responsible for maintaining patient records for services that it
provides.) State law requires record information that should include:
documentation of personal interviews; diagnosis and treatment
recommendations; records of professional visits and consultations; and
consultant notes which shall be appropriately initialed or signed.
7. ICRs Regarding Condition of Participation: Quality Assessment and
Performance Improvement Program (QAPI) (Proposed Sec. 485.536)
At proposed Sec. 485.536, we require REHs to develop, implement,
and maintain an effective, ongoing, REH-wide, data-driven quality
assessment and performance improvement (QAPI) program. The REH's
governing body must ensure that the program reflects the complexity of
the REH's organization and services; involves all REH departments and
services (including those services furnished under contract or
arrangement); and focuses on indicators related to improved health
outcomes and the prevention and reduction of medical errors. The REH
must maintain and demonstrate evidence of its QAPI program for review
by CMS. In addition, REHs must comply with all of the requirements set
forth in proposed Sec. 485.536(a) through (e). We believe that the REH
QAPI leadership (consisting of a physician, and/or administrator, mid-
level practitioner, and a nurse) would need to have at least one and
potentially two meetings to ensure that the current QAPI program that
the provider has established is in accordance with the proposed
requirements at Sec. 485.536. The first meeting would be to discuss
the current QAPI program and what, if anything, needs to be revised
based on the proposed QAPI requirements at Sec. 485.536. The second
meeting, if needed, would be to discuss strategies to update the
current policies, and then to discuss the process for incorporating
those changes. We believe that these meetings would take approximately
2 hours each. We estimate that the physician would have a limited
amount of time, approximately 1 hour to devote to the QAPI activities.
Additionally, we estimate these activities would require 4 hours of an
administrator's time, 4 hours of a mid-level practitioner's time, 8
hours of a nurse's time, and 2 hours of a clerical staff person's time
for a total of 19 burden hours. We believe that the REH's QAPI
leadership would need to meet periodically to review and discuss the
changes that would need to be made to their program. We also believe
that a nurse would likely spend more time developing the program with
the mid-level practitioner. The physician would likely review and
approve the program. The clerical staff member would probably assist
with the program's development and ensure that the program was
disseminated to all of the necessary parties in the REH.
Based on these factors, we estimate that for each REH to comply
with the requirements in this section it would require annually 19
burden hours (1 hour for a physician + 4 hours for an administrator + 4
hours for a mid-level practitioner + 8 hours for a nurse + 2 hours for
a clerical staff person) at a cost of $1,810 ($210 for a physician (1
hour x $210) + $488 for an administrator (4 hours x $122) + $404 for a
mid-level practitioner (4 hours x $101) + $632 for a nurse (8 hours x
$79) + $76 for a
[[Page 40383]]
clerical staff person (2 hours x $38)). Therefore, for all 68 REHs to
comply with these requirements, it would require 1,292 burden hours (19
hours x 68 REHs) at a cost of approximately $123,080 ($1,810 x 68
REHs).
8. ICRs Regarding Condition of Participation: Emergency Preparedness
(Sec. 485.542)
Section 485.542 sets forth the proposed emergency preparedness
requirements for REHs. We note that these emergency preparedness
standards are consistent national parameters that all Medicare and
Medicaid participating providers and suppliers must meet. This includes
both rural hospitals and CAHs and therefore facility that converts to
an REH would have already incurred the costs to develop and implement
their emergency preparedness plan. Based on this, the burden associated
with these requirements would be the on-going costs to review, maintain
and implement the emergency preparedness program to ensure ongoing
compliance with the requirements and as such we have developed this
collection of information (COI) section based largely on the existing
COI burden for CAHs and hospitals.
Standard: Risk Assessment and Planning (Sec. 485.542(a))
We propose to require REHs to develop and maintain an emergency
preparedness plan that must be reviewed and updated at least
biennially. We expect that each REH facilities director ($104 per hour)
would conduct a thorough risk assessment that will consider its
location and geographical area; patient population, including those
with special needs; and the type of services they have the ability to
provide in an emergency (12 hours biennially or 6 hours annually) based
on the services that they are now providing as an REH. They each would
also need to review the measures needed to ensure continuity of its
operation, including delegations and succession plans. We estimate that
ongoing compliance with this requirement would require 6 burden hours
annually (12 biennially) from the REH facilities director. Therefore,
for all 68 REHs to comply with this requirement, it would require 408
burden hours (6 x 68 REHs) at a cost of approximately $42,432 (408
hours x $104).
Standard: Policies and Procedures (Sec. 485.542(b))
REHs are required to maintain emergency preparedness policies and
procedures in accordance with their emergency plan, risk assessment,
and communication plan. Each needs to review their emergency
preparedness policies and procedures and revise, or in some cases,
develop new policies and procedures that would ensure that the
emergency preparedness plans address the specific requirements of the
regulations.
We believe that the requirement for REHs to review and update their
policies and procedures annually constitutes a usual and customary
business practice and is not subject to the PRA in accordance with 5
CFR 1320.3(b)(2). However, we are soliciting comment on whether this is
a customary business practice or whether this would impose an
additional burden on those providers eligible to convert to an REH.
Standard: Communication Plan (Sec. 485.542(c))
REHs are required to develop and maintain an emergency preparedness
communication plan that complies with both Federal and state law and
must be reviewed and updated at least annually. The burden associated
with this requirement would be the time and effort necessary to review,
revise, and if necessary, develop a new communications plan to ensure
that it complies with the requirements of this regulation. However, we
believe that most REHs have some type of emergency preparedness
communication plan based on their prior status as a CAH or rural
hospital. It is standard practice in the health care industry to have
and maintain contact information for both staff and outside sources of
assistance; alternate means of communications in case there is an
interruption in phone service to the facility, such as cell phones; and
a method for sharing information and medical documentation with other
health care providers to ensure continuity of care for their patients.
If any revisions or additions are necessary to satisfy the
requirements as an REH, we expect the revisions or additions would be
those incurred during the course of normal business and thereby impose
no additional burden. Thus, the ICRs related to the communication plan
would constitute a usual and customary business practice as stated in
the implementing regulations of the PRA at 5 CFR 1320.3(b)(2) and we
did not include this activity in the burden analysis. We are soliciting
comment on whether this is a customary business practice or whether
this would impose an additional burden on those providers eligible to
convert to an REH.
Standard: Training and Testing (Sec. 485.542(d))
REHs are required to develop and maintain an emergency preparedness
training and testing program. The training program must include initial
training in emergency preparedness policies and procedures for all new
and existing staff, individuals providing services under arrangement,
and volunteers, consistent with their expected roles and must be
documented. The testing program must include participation in a full-
scale exercise that is community-based or when a community-based
exercise is not accessible, an individual, facility-based. If an actual
natural or man-made emergency that requires activation of the emergency
plan is experienced, then this requirement is exempt for 1 year
following the onset of the actual event. In addition, the testing
program must include one additional testing exercise, which may be
determined by the REH. The training must be provided biennially and two
testing exercises must be conducted annually.
We expect that all REHs will review their current training programs
in their current capacity as hospitals or CAHs, and compare them to
their risk assessments and emergency preparedness plans, emergency
policies and procedures, and emergency communication plans. The CAHs
will need to revise and, if necessary, develop new sections or
materials to ensure their training and testing programs complied with
our requirements. We anticipate that ongoing compliance with this
requirement will require the involvement of an administrator, the mid-
level practitioner, the facilities director, and clerical staff. We
expect that a mid-level practitioner will perform the initial review of
the training program (4 hours), brief the administrator and the
director of facilities (2 hours), and clerical staff to revise or
develop new sections for the training program (1 hour), based on the
group's decisions, if necessary. This will result in a cost of $894
($404 for a mid-level practitioner (4 hours x $101) + $244 for an
administrator (2 hours x $122) + $208 for a director of facilities (2
hours x $104) + $38 for a clerical staff person (1 hour x $38)) for
each REH. Therefore, for all REHs to comply with this requirement it
will require an estimated 476 burden hours (7 hours x 68 REHs) at a
cost of $60,792 ($894 x 68 REHs).
[[Page 40384]]
9. ICRs Regarding Conditions of Participation: Physical Environment
(Sec. 485.544)
Standard: Life Safety Code (Sec. 485.544)
The REH must meet the applicable provisions of the 2012 edition of
the Life Safety Code (LSC) of the National Fire Protection Association.
If CMS finds that the state has a fire and safety code imposed by the
state law that adequately protects patients, CMS may allow the state
survey agency to apply the state's fire and safety code instead of the
LSC if waiving the provisions of the LSC does not adversely affect the
health and safety of patients. This regulation requires a REH to
maintain written evidence of regular inspections and approval by state
fire control agencies. We estimate that the burden associated with
maintaining written evidence of state inspections and approval would be
an average of 30 minutes for clerical personnel to file the
documentation, for a total of 34 burden hours (0.5 hours x 68 REHs) and
a cost of $1,292 (34 hours x $38). The burden will be accounted for in
the Information Collection Request under OMB control number 0938-XXXX.
The table that follows summarizes our estimates of burden hours and
costs for REHs. We emphasize that these estimates assume 68 conversions
and that the number actually converting could be a fraction of this
figure, or much higher, which as discussed earlier is an uncertainty
addressed in both the NC RHRP and CLA study that estimated likely
conversions. Our estimates of the cost per entity, however, would not
be affected by the number of conversions.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP06JY22.005
BILLING CODE 4120-01-C
D. Critical Access Hospitals
1. ICRs Regarding Condition of Participation: Patient's Rights (Sec.
485.614)
Standard: Notice of Rights: Sec. 485.614(a)(1) and (2)
Proposed Sec. 485.614(a) proposes to require CAHs to notify the
patient of their rights and of whom to contact to file a grievance. We
allow REHs the flexibility to use different approaches to meet this
CoP. We have set forth general elements that should be common to all
grievance processes, but have not delineated strategies and policies
for implementing this system. We believe that in large measure, CAHs
would be
[[Page 40385]]
able to use existing systems for providing patients with information
and handling complaints, and the elements listed in the regulation only
serve to give basic assurance that these systems are responsive to
patient grievances and act effectively. A less specific approach would
permit a nominal, non-functional system that in essence did not serve
the very purpose intended by the regulation. Costs associated with
formalizing a process and modifying any existing notices or processes
will most likely be offset by a reduction in patient-initiated lawsuits
regarding care, and should provide a valuable tool for targeting
internal quality assurance mechanisms.
We propose that the patient be provided with written notice
containing a contact person's name, the steps taken on behalf of the
patient to investigate the grievance, the results of the grievance
process, and the date of completion. Steps taken on behalf of the
patient need not include a detailed description of who was spoken to
and when. It might merely be that the appropriate staff were
interviewed and that records were reviewed to investigate the
grievance, and that the investigation found the grievance to be either
unsubstantiated or substantiated. Second, the figures represented are
estimates. We know of no existing system that tracks how many
complaints are lodged in aggregate in CAHs each year; however, we
believe that the grievance response can largely rely on standardized
language with only relevant information filled in, or could be created
in a check-sheet format, or in many other ways.
Thus, the burden associated with this requirement is the time and
effort necessary to modify any existing notices to include the proposed
grievance process requirements. We believe that an office assistant may
be tasked with drafting or updating the notices and distributing or
posting, as appropriate, the information. We estimate that this would
require no more than two hours of the clerical staff time. The burden
hours are 2,720 (2 hours x 1,360). Based on this we estimate that this
will create a one-time cost of $103,360 (2,720 hours x $38). In
addition, we estimate that it will require the office assistant 2
minutes (.0333 hours) to provide the notice per CAH patient on an
annual basis. The number of notices required will depend on the number
of patients received at the CAH. Therefore, the per facility burden
associated with providing the notice will vary based on the unique
factors of the CAH. According to a 2013 OIG report, there were
approximately 1,753 patient visits per CAH in 2011.\33\ Based on this
estimate, the burden hours would be 58 hours (.0333 hours x 1,753
notices). The total burden hours would be 78,880 hours (58 hours x
1,360 CAHs). Therefore, we estimate that the CAH would have had to
inform each of these patient of their rights at a cost of $2,997,440
($38 x 78,880 hours).
---------------------------------------------------------------------------
\33\ https://oig.hhs.gov/oei/reports/oei-05-12-00081.pdf.
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In its resolution of a grievance, a CAH must provide the patient
with written notice of its decision that contains the name of the CAH
contact person, the steps taken on behalf of the patient to investigate
the grievance, the results of the grievance process, and the date of
completion.
The burden associated with this requirement is the time and effort
necessary to disclose the written notice to each patient who filed a
grievance. We estimate that on average it will take each REH 15 minutes
to develop and disseminate the required notice and estimate that a CAH
may have to provide 50 notices on an annual basis. The burden hours for
each CAH will be 12.5 (0.25 hour x 50 notices) for a total of 17,000
burden hours (12.5 hours x 1,360 CAHs). The total annual burden cost is
$646,000 ($38 x 17,000).
Therefore, the total burden hours are 98,600 (78,880 + 17,000 +
2,720) and the total cost associated with this requirement is
$3,746,800 ($103,360 to update notices, $2,997,440 to provide the
notices, and $646,000 to provide the results of a grievance
investigation).
Standard: Confidentiality of Patient Records (Sec. 485.614(d))
Proposed Sec. 485.614(d), which sets forth the patient's right to
access information in their records, will involve minimal burden as
many states' existing laws cover this point. We have not proposed to
require disclosure of all records, inasmuch as we recognize that there
are situations where such a release could be harmful to the patient or
another individual. Furthermore, we have not taken a prescriptive
approach in specifying how quickly this information must be provided to
the patient, or by setting a rate that the CAH can charge. In the
absence of state law, the REH should charge whatever is reasonable and
customary in its community for duplication services (based on rates at
local commercial copy centers, post offices, or other venues in which
one could make photocopies). Therefore, while this requirement is
subject to the PRA, we believe that the burden associated with this
requirement is exempt from the PRA, as defined in 5 CFR 1320.3(b)(2)
and (3) because this requirement is considered standard industry
practice and/or is required under state or local law.
Standard: Restraint and Seclusion (Sec. 485.614(e))
Proposed Sec. 485.614(e) requires that each CAH have written
policies and procedures regarding the use of restraint and seclusion
that are consistent with current standards of practice. While the
requirement is subject to the PRA, we believe the associated burden is
exempt in accordance with 5 CFR 1320.3(b)(2) because the time, and
effort, and financial resources necessary to comply with this
requirement would be incurred by persons in the normal course of their
activities. These are reasonable and customary state practices and the
state would impose this standard for efficient utilization of Medicare
and Medicaid services in the absence of a Federal requirement. However,
we are soliciting comment on whether this is a customary business
practice or whether this would impose an additional burden.
Standard: Restraint and Seclusion: Staff Training Requirements (Sec.
485.614(f))
Proposed Sec. 485.614(f) requires facilities to establish staff
training requirements for the use of restraints and seclusion. The CAH
must provide competency-based training and education of CAH personnel
and staff, including medical staff, and, as applicable, personnel
providing contracted services in the CAH, on the use of restraint and
seclusion. While these information collection requirements are subject
to the PRA, we believe the burden associated with them are exempt as
defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial
resources necessary to comply with the requirement are incurred by
persons in the normal course of their activities. However, we are
soliciting comment on whether this is a customary business practice or
whether this would impose an additional burden.
Standard: Death Reporting Requirements (Sec. 485.614(g))
Proposed Sec. 485.614(g) requires the facility to report the death
of a resident associated with seclusion or restraint to the CMS
regional office. A report must include the name of the resident
involved in the serious occurrence, a description of the occurrence,
and the name, street address, and telephone number of the facility.
We estimate it will take 5 minutes to report each death to the CMS
regional
[[Page 40386]]
office and to document that report. We estimate fewer than 10 deaths
annually for all 1,360 facilities. Five (5) minutes x 10 deaths
annually would equate to a national burden of 50 minutes per year. The
hourly adjusted rate for a Medical and Health Service Manager
responsible for notifying the CMS regional office of a death a
documenting the report is $122/hour. Multiplying the total burden of
0.83 hours by the hourly wage yields an associated cost of about
$101.26.
[GRAPHIC] [TIFF OMITTED] TP06JY22.006
The burden for the proposed CAH provisions will be accounted for in
the Information Collection Request under OMB control number 0938-XXXX.
If you comment on these information collection requirements, that
is, reporting, recordkeeping or third-party disclosure requirements,
please submit your comments electronically as specified in the
ADDRESSES section of this proposed rule.
Comments must be received by August 29, 2022.
IV. Response to Comments
Because of the large number of public comments, we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Statement
We have examined the impact of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism
(August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and 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). A
Regulatory Impact Analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This proposed rule addresses the CoPs required for REH designation,
which in accordance with the statute, may be sought by CAHs and small
rural hospitals. It also proposes several new CAH requirements that we
believe are appropriate under the existing program as well as to REHs.
However, note that the costs of these CAH proposals are not
attributable to the new REH program (except where such costs are
experienced by entities that remain open due to the REH option but
would have closed otherwise). The baseline for the estimates of REH
costs is the status quo had the new program had not been created.
Because the proposed CoPs for the new REH provider type are similar to
those already met by the facilities that will potentially convert to
REH status, and assuming that the estimated number of hospitals
converting to the new program is approximately correct, the provisions
of this proposed rule do not reach the economic threshold and thus it
is not considered a major rule. This would remain the case if the
number converting were to be significantly higher or lower. This is
also an upper bound for these costs on a per facility basis, since for
collection of information purposes we did not subtract offsetting
savings from providers who would already meet these standards and who
decide to make little change when updating their status. Payment
policies for REHs will be developed under separately proposed
rulemaking, and we expect that the total economic impact of the new
program including both Conditions of Participation and payment costs
will exceed the threshold for an economically significant impact, and
will be addressed at that time.
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most hospitals and most other healthcare
providers and suppliers are small entities, either by nonprofit status
or by having revenues of less than $8.0 million to $41.5 million in any
1 year. Individuals and states are not included in the definition of a
small entity. We estimate that almost all of the new REH facilities,
and the great majority of CAHs, are or would be small entities on the
basis of legal status, revenues, or both. The North American Industry
Classification System Code for the converting hospitals is 622110
(General Medical and Surgical Hospitals), and for the REHs to which
they convert the closest Code is 621493 (Freestanding Ambulatory
Surgical and Emergency Centers).
HHS uses an increase in costs or decrease in revenues of more than
3
[[Page 40387]]
percent as its threshold for ``significant economic impact''. Our
collection of information estimates are that the 68 facilities
converting to REH status (as estimated by the NC RHRP study referenced
in the COI section) would face average annual costs of about $22,600
each (68 x $22,600 = $1,537,000 (COI burden estimate)). The North
Carolina Rural Health Research Program estimated that the 68 hospitals
it thought most likely to convert to REH status had average patient
revenues of $7.3 million. For these facilities, the 3 percent threshold
would be about $219,000, almost ten times our estimated cost of
information collection. The CLA study does not present average facility
revenues. However, we note that while it reaches a broad range of
conversion estimates, we do not believe that it would have reached
different conclusions had it presented such calculations. These
relationships between revenues and costs would not be substantially
different if the number of conversions was substantially fewer or
substantially greater in number. More importantly, these facilities
would be converting voluntarily to the new program. We expect that the
costs any facility faces would be less than the anticipated gains of
conversion, or it would not convert. This positive relationship of
expected gains from conversion compared to current costs and revenues
is explicit in the CLA modeling.
The effects of the proposed policy changes on CAHs are even
smaller. The average annual cost per CAH for the new Conditions of
Participation would be about $2,755 each (1,360 facilities x $2,755 =
the $3,747,000 COI estimate), a tiny fraction of 1 percent of annual
patient revenues estimated in the NC RHRP study at about $24 million a
year. Moreover, the proposed change in the definition of primary roads
could prevent the loss of the CAH designation for 3 to 4 CAHs. We note
that we propose no change in rural hospital standards, so they are not
directly regulated by this proposed rule.
For these reasons, an Initial Regulatory Flexibility Analysis
(IRFA) is not required. Furthermore, as described provision by
provision earlier in this preamble, we carefully sought to keep
regulatory burdens on REH providers to a reasonable minimum, taking
into account our obligation to reduce health care inequities, their
small size, and the statutory and practical limitations on their status
as providers. For example, we propose to allow systems composed of
multiple and separately certified hospitals, CAHs, and/or REHs to have
unified or integrated governing bodies, unified infection prevention
and control and antibiotic stewardship programs, and unified and
integrated medical staff. Taking all these factors into account, this
analysis and the preamble as a whole meet the scope and content
required for IRFAs.
Accordingly, we are not preparing an analysis under the RFA because
we have determined, and the Secretary certifies, that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. We do, however, request comments on our
estimates and analysis, and on any alternatives that would reduce
unnecessarily costly effects.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 603 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. We are not preparing
an analysis for section 1102(b) of the Act because we have determined,
and the Secretary certifies, that this proposed rule would 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 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 2022, that
threshold is approximately $165 million. This proposed rule would not
impose a mandate that will result in the expenditure by state, local,
and Tribal Governments, in the aggregate, or by the private sector, of
more than $165 million in any 1 year.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on June 9, 2022.
List of Subjects
42 CFR Part 485
Grant programs--health, Health facilities, Incorporation by
reference, Medicaid, Privacy, Reporting and recordkeeping requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
1. The authority citation for part 485 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Subpart E is added to read as follows:
Subpart E--Conditions of Participation: Rural Emergency Hospitals
(REHs)
Sec.
485.500 Basis and scope.
485.502 Definitions.
485.504 Basic requirements.
485.506 Designation and certification of REHs.
485.508 Condition of participation: Compliance with Federal, state,
and local laws and regulations.
485.510 Condition of participation: Governing body and
organizational structure of the REH.
485.512 Condition of participation: Medical staff.
485.514 Condition of participation: Provision of services.
485.516 Condition of participation: Emergency services.
485.518 Condition of participation: Laboratory services.
485.520 Condition of participation: Radiologic services.
485.522 Condition of participation: Pharmaceutical services.
485.524 Condition of participation: Additional outpatient medical
and health services.
485.526 Condition of participation: Infection prevention and control
and antibiotic stewardship programs.
485.528 Condition of participation: Staffing and staff
responsibilities.
485.530 Condition of participation: Nursing services.
485.532 Condition of participation: Discharge planning.
485.534 Condition of participation: Patient's rights.
485.536 Condition of participation: Quality assessment and
performance improvement program.
[[Page 40388]]
485.538 Condition of participation: Agreements.
485.540 Condition of participation: Medical records.
485.542 Condition of participation: Emergency preparedness.
485.544 Condition of participation: Physical environment.
485.546 Condition of participation: Skilled nursing facility
distinct part unit.
Subpart E--Conditions of Participation: Rural Emergency Hospitals
(REHs)
Sec. 485.500 Basis and scope.
Section 1861(kkk) of the Act requires the Secretary to establish
the conditions REHs must meet in order to participate in the Medicare
program and which are considered necessary to ensure the health and
safety of patients receiving services at these entities.
Sec. 485.502 Definitions.
As used in this subpart, Rural Emergency Hospital or REH means an
entity that operates for the purpose of providing emergency department
services, observation care, and other outpatient medical and health
services specified by the Secretary in which the annual per patient
average length of stay does not exceed 24 hours. The entity must not
provide inpatient services, except those furnished in a unit that is a
distinct part licensed as a skilled nursing facility to furnish post-
REH or post-hospital extended care services.
Sec. 485.504 Basic requirements.
Participation as an REH is limited to facilities that--
(a) Meet the definition in Sec. 485.502.
(b) Have in effect a provider agreement as defined at Sec. 489.3
of this chapter to provide services.
(c) Meet the conditions of participation set out in this subpart.
Sec. 485.506 Designation and certification of REHs.
CMS certifies a facility as an REH if the facility was, as of
December 27, 2020--
(a) A critical access hospital; or
(b) A hospital as defined in section 1886(d)(1)(B) of the Act with
not more than 50 beds located in a county (or equivalent unit of local
government) that is considered rural (as defined in section
1886(d)(2)(D) of the Act); or
(c) A hospital as defined in section 1886(d)(1)(B) of the Act with
not more than 50 beds that was treated as being located in a rural area
that has had an active reclassification from urban to rural status as
specified in Sec. 412.103 of this chapter as of December 27, 2020.
Sec. 485.508 Condition of participation: Compliance with Federal,
state, and local laws and regulations.
(a) The REH must be in compliance with applicable Federal laws
related to the health and safety of patients.
(b) The REH must be located in a state that provides for the
licensing of such hospitals under state or applicable local law; and is
(1) Licensed in the state as an REH; or
(2) Approved as meeting standards for licensing established by the
agency of the state or locality responsible for licensing hospitals.
(c) The REH must assure that personnel are licensed or meet other
applicable standards that are required by state or local laws to
provide services within the applicable scope of practice.
Sec. 485.510 Condition of participation: Governing body and
organizational structure of the REH.
There must be an effective governing body, or responsible
individual or individuals, that is legally responsible for the conduct
of the REH. If an REH does not have an organized governing body, the
person or persons legally responsible for the conduct of the REH must
carry out the functions specified in this subpart that pertain to the
governing body.
(a) Standard: Medical staff. The governing body must:
(1) Determine, in accordance with state law, which categories of
practitioners are eligible candidates for appointment to the medical
staff.
(2) Appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff.
(3) Ensure that the medical staff has bylaws.
(4) Approve medical staff bylaws and other medical staff rules and
regulations.
(5) Ensure that the medical staff is accountable to the governing
body for the quality of care provided to patients.
(6) Ensure the criteria for selection are individual character,
competence, training, experience, and judgment.
(i) Members of the medical staff must be legally and professionally
qualified for the positions to which they are appointed and for the
performance of privileges granted. The REH grants privileges in
accordance with recommendations from qualified medical personnel.
(ii) Medical staff privileges must be periodically reappraised by
the REH. The scope of procedures performed in the REH must be
periodically reviewed and amended as appropriate.
(iii) If the REH assigns patient care responsibilities to
practitioners other than physicians, it must have established policies
and procedures, approved by the governing body, for overseeing and
evaluating their clinical activities.
(7) Ensure that under no circumstances is the accordance of staff
membership or professional privileges in the REH dependent solely upon
certification, fellowship, or membership in a specialty body or
society.
(8) Ensure that, when telemedicine services are furnished to the
REH's patients through an agreement with a distant-site hospital, the
agreement is written and that it specifies that it is the
responsibility of the governing body of the distant-site hospital to
meet the requirements in paragraphs (a)(1) through (7) of this section
with regard to the distant-site hospital's physicians and practitioners
providing telemedicine services. The governing body of the REH whose
patients are receiving the telemedicine services may, in accordance
with Sec. 485.512(a)(3), grant privileges based on its medical staff
recommendations that rely on information provided by the distant-site
hospital.
(9) Ensure that when telemedicine services are furnished to the
REH's patients through an agreement with a distant-site telemedicine
entity, the written agreement specifies that the distant-site
telemedicine entity is a contractor of services to the REH and as such,
in accordance with paragraph (b) of this section, furnishes the
contracted services in a manner that permits the REH to comply with all
applicable conditions of participation for the contracted services,
including, but not limited to, the requirements in paragraphs (a)(1)
through (7) of this section with regard to the distant-site
telemedicine entity's physicians and practitioners providing
telemedicine services. The governing body of the REH whose patients are
receiving the telemedicine services may, in accordance with Sec.
485.512(a)(4), grant privileges to physicians and practitioners
employed by the distant-site telemedicine entity based on such REH's
medical staff recommendations; such staff recommendations may rely on
information provided by the distant-site telemedicine entity.
(10) Consult directly with the individual assigned the
responsibility for the organization and conduct of the REH's medical
staff, or their designee. At a minimum, this direct consultation must
occur periodically throughout the fiscal or calendar year and include
discussion of matters related to the quality of medical care provided
to patients of the REH. For a multi-facility
[[Page 40389]]
system, including a multi-hospital or multi-REH system, using a single
governing body, the single multi-facility or multi-REH system governing
body must consult directly with the individual responsible for the
organized medical staff (or their designee) of each hospital or REH
within its system in addition to the other requirements of this
paragraph (a).
(b) Standard: Contracted services. The governing body must be
responsible for services furnished in the REH whether or not they are
furnished under contracts. The governing body must ensure that a
contractor of services (including one for shared services and joint
ventures) furnishes services that permit the REH to comply with all
applicable conditions of participation and standards for the contracted
services.
(1) The governing body must ensure that the services performed
under a contract are provided in a safe and effective manner.
(2) The REH must maintain a list of all contracted services,
including the scope and nature of the services provided.
Sec. 485.512 Condition of participation: Medical staff.
The REH must have an organized medical staff that operates under
bylaws approved by the governing body, and which is responsible for the
quality of medical care provided to patients by the REH.
(a) Standard: Eligibility and process for appointment to medical
staff. The medical staff must be composed of doctors of medicine or
osteopathy. In accordance with state law, including scope-of-practice
laws, the medical staff may also include other categories of physicians
(as listed at paragraph (c)(1) of this section) and non-physician
practitioners who are determined to be eligible for appointment by the
governing body.
(1) The medical staff must periodically conduct appraisals of its
members.
(2) The medical staff must examine the credentials of all eligible
candidates for medical staff membership and make recommendations to the
governing body on the appointment of these candidates in accordance
with state law, including scope-of-practice laws, and the medical staff
bylaws, rules, and regulations. A candidate who has been recommended by
the medical staff and who has been appointed by the governing body is
subject to all medical staff bylaws, rules, and regulations, in
addition to the requirements contained in this section.
(3) When telemedicine services are furnished to the REH's patients
through an agreement with a distant-site hospital, the governing body
of the REH whose patients are receiving the telemedicine services may
choose, in lieu of the requirements in paragraphs (a)(1) and (2) of
this section, to have its medical staff rely upon the credentialing and
privileging decisions made by the distant-site hospital when making
recommendations on privileges for the individual distant-site
physicians and practitioners providing such services, if the REH's
governing body ensures, through its written agreement with the distant-
site hospital, that all of the following provisions are met:
(i) The distant-site hospital providing the telemedicine services
is a Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site hospital providing the telemedicine
services, which provides a current list of the distant-site physician's
or practitioner's privileges at the distant-site hospital.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the state in which the REH whose
patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the REH whose patients are receiving the
telemedicine services, the REH has evidence of an internal review of
the distant-site physician's or practitioner's performance of these
privileges and sends the distant-site hospital such performance
information for use in the periodic appraisal of the distant-site
physician or practitioner. At a minimum, this information must include
all adverse events that result from the telemedicine services provided
by the distant-site physician or practitioner to the REH's patients and
all complaints the REH has received about the distant-site physician or
practitioner.
(4) When telemedicine services are furnished to the REH's patients
through an agreement with a distant-site telemedicine entity, the
governing body of the REH whose patients are receiving the telemedicine
services may choose, in lieu of the requirements in paragraphs (a)(1)
and (2) of this section, to have its medical staff rely upon the
credentialing and privileging decisions made by the distant-site
telemedicine entity when making recommendations on privileges for the
individual distant-site physicians and practitioners providing such
services, if the REH's governing body ensures, through its written
agreement with the distant-site telemedicine entity, that the distant-
site telemedicine entity furnishes services that, in accordance with
paragraph (d) of this section, permit the REH to comply with all
applicable conditions of participation for the contracted services. The
REH's governing body must also ensure, through its written agreement
with the distant-site telemedicine entity, that all of the following
provisions are met:
(i) The distant-site telemedicine entity's medical staff
credentialing and privileging process and standards at least meet the
standards at Sec. 485.510(a)(1) through (7) and paragraphs (a)(1) and
(2) of this section.
(ii) The individual distant-site physician or practitioner is
privileged at the distant-site telemedicine entity providing the
telemedicine services, which provides the REH with a current list of
the distant-site physician's or practitioner's privileges at the
distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a
license issued or recognized by the state in which the REH whose
patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who
holds current privileges at the REH whose patients are receiving the
telemedicine services, the REH has evidence of an internal review of
the distant-site physician's or practitioner's performance of these
privileges and sends the distant-site telemedicine entity such
performance information for use in the periodic appraisal of the
distant-site physician or practitioner. At a minimum, this information
must include all adverse events that result from the telemedicine
services provided by the distant-site physician or practitioner to the
REH's patients, and all complaints the REH has received about the
distant-site physician or practitioner.
(b) Standard: Medical staff organization and accountability. The
medical staff must be well organized and accountable to the governing
body for the quality of the medical care provided to patients.
(1) The medical staff must be organized in a manner approved by the
governing body.
(2) If the medical staff has an executive committee, a majority of
the members of the committee must be doctors of medicine or osteopathy.
(3) The responsibility for organization and conduct of the medical
staff must be assigned only to one of the following:
[[Page 40390]]
(i) An individual doctor of medicine or osteopathy.
(ii) A doctor of dental surgery or dental medicine, when permitted
by state law of the state in which the hospital is located.
(iii) A doctor of podiatric medicine, when permitted by state law
of the state in which the hospital is located.
(4) If an REH is part of a system consisting of multiple separately
certified hospitals, critical access hospitals, and/or REHs, and the
system elects to have a unified and integrated medical staff for its
member hospitals, critical access hospitals, and/or REHs after
determining that such a decision is in accordance with all applicable
state and local laws, each separately certified REH must demonstrate
that:
(i) The medical staff members of each separately certified REH in
the system (that is, all medical staff members who hold specific
privileges to practice at that REH) have voted by majority, in
accordance with medical staff bylaws, either to accept a unified and
integrated medical staff structure or to opt out of such a structure
and to maintain a separate and distinct medical staff for their
respective REH;
(ii) The unified and integrated medical staff has bylaws, rules,
and requirements that describe its processes for self-governance,
appointment, credentialing, privileging, and oversight, as well as its
peer review policies and due process rights guarantees, and which
include a process for the members of the medical staff of each
separately certified REH (that is, all medical staff members who hold
specific privileges to practice at that REH) to be advised of their
rights to opt out of the unified and integrated medical staff structure
after a majority vote by the members to maintain a separate and
distinct medical staff for their REH;
(iii) The unified and integrated medical staff is established in a
manner that takes into account each member REH's unique circumstances
and any significant differences in patient populations and services
offered in each hospital, CAH, and REH; and
(iv) The unified and integrated medical staff establishes and
implements policies and procedures to ensure that the needs and
concerns expressed by members of the medical staff, at each of its
separately certified hospitals, CAHs, and REHs, regardless of practice
or location, are given due consideration, and that the unified and
integrated medical staff has mechanisms in place to ensure that issues
localized to particular hospitals, CAHs, and REHs are duly considered
and addressed.
(c) Standard: Medical staff bylaws. The medical staff must adopt
and enforce bylaws to carry out its responsibilities. The bylaws must:
(1) Be approved by the governing body.
(2) Include a statement of the duties and privileges of each
category of medical staff (for example, active, courtesy, etc.).
(3) Describe the organization of the medical staff.
(4) Describe the qualifications to be met by a candidate in order
for the medical staff to recommend that the candidate be appointed by
the governing body.
(5) Include criteria for determining the privileges to be granted
to individual practitioners and a procedure for applying the criteria
to individuals requesting privileges. For distant-site physicians and
practitioners requesting privileges to furnish telemedicine services
under an agreement with the REH, the criteria for determining
privileges and the procedure for applying the criteria are also subject
to the requirements in Sec. 485.510(a)(8) and (9) and paragraphs
(a)(3) and (4) of this section.
Sec. 485.514 Condition of participation: Provision of services.
(a) The REH's health care services must be furnished in accordance
with appropriate written policies that are consistent with applicable
state law.
(b) The policies must be developed with the advice of members of
the REH's professional health care staff, including one or more doctors
of medicine or osteopathy and one or more physician assistants, nurse
practitioners, or clinical nurse specialists, if they are on staff
under the provisions of Sec. 485.528(b)(1).
(c) The policies must include the following:
(1) A description of the services the REH furnishes, including
those furnished through agreement or arrangement.
(2) Policies and procedures for emergency medical services.
(3) Guidelines for the medical management of health problems that
include the conditions requiring medical consultation and/or patient
referral, the maintenance of health care records, and procedures for
the periodic review and evaluation of the services furnished by the
REH.
(4) Policies and procedures that address the post-acute care needs
of patients receiving services in the REH.
(d) The policies must be reviewed at least biennially by the group
of professional personnel required under paragraph (b) of this section
and updated as necessary by the REH.
Sec. 485.516 Condition of participation: Emergency services.
The REH must provide the emergency care necessary to meet the needs
of its patients in accordance with acceptable standards of practice.
(a) Standard: Organization and direction. The emergency services of
the REH must be--(1) Organized under the direction of a qualified
member of the medical staff; and
(2) Integrated with other departments of the REH.
(b) Standard: Personnel. There must be adequate medical and nursing
personnel qualified in emergency care to meet the written emergency
procedures and needs anticipated by the facility.
(c) Standard: Compliance with CAH requirements. The REH must meet
the requirements specified in Sec. 485.618, with respect to:
(1) 24-hour availability of emergency services (Sec. 485.618(a)).
(2) Equipment, supplies, and medication (Sec. 485.618(b)).
(3) Blood and blood products (Sec. 485.618(c)).
(4) Personnel (Sec. 485.618(d)).
(5) Coordination with emergency response systems (Sec.
485.618(e)).
Sec. 485.518 Condition of participation: Laboratory services.
The REH must provide basic laboratory services essential to the
immediate diagnosis and treatment of the patient consistent with
nationally recognized standards of care for emergency services. The REH
must ensure that--
(a) Laboratory services are available, either directly or through a
contractual agreement with a certified laboratory that meets
requirements of part 493 of this chapter.
(b) Emergency laboratory services are available 24 hours a day.
Sec. 485.520 Condition of participation: Radiologic services.
The REH must maintain, or have available, diagnostic radiologic
services. If therapeutic services are also provided, the therapeutic
services, as well as the diagnostic services, must be furnished by the
REH and provided by personnel qualified under state law. The REH must
ensure that REH patients or personnel are not exposed to radiation
hazards.
(a) Standard: Radiologic services. The REH must maintain, or have
available, radiologic services according to needs of the patients.
(b) Standard: Safety for patients and personnel. The radiologic
services,
[[Page 40391]]
particularly ionizing radiology procedures, must be free from hazards
for patients and personnel.
(1) Proper safety precautions must be maintained against radiation
hazards. This includes adequate shielding for patients, personnel, and
facilities, as well as appropriate storage, use, and disposal of
radioactive materials.
(2) Periodic inspection of equipment must be made and hazards
identified must be promptly corrected.
(3) Radiation workers must be checked periodically, by the use of
exposure meters or badge tests, for amount of radiation exposure.
(4) Radiologic services must be provided only on the order of
practitioners with clinical privileges or, consistent with state law,
of other practitioners authorized by the medical staff and the
governing body to order the services.
(c) Standard: Personnel. (1) The REH must have a full-time, part-
time, or consulting qualified radiologist, or other personnel qualified
under State law, to interpret only those radiologic tests that are
determined by the medical staff to require specialized knowledge. For
purposes of this section, a radiologist is a doctor of medicine or
osteopathy who is qualified by education and experience in radiology.
(2) Only personnel designated as qualified by the medical staff may
use the radiologic equipment and administer procedures.
(d) Standard: Records. Records of radiologic services must be
maintained.
(1) The radiologist or other practitioner who performs radiology
services must sign reports of their interpretations.
(2) The REH must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.
Sec. 485.522 Condition of participation: Pharmaceutical services.
The REH must have pharmaceutical services that meet the needs of
its patients. The REH must have a pharmacy or a drug storage area that
is directed by a registered pharmacist or other qualified individual in
accordance with state scope of practice laws. The medical staff is
responsible for developing policies and procedures that minimize drug
errors. This function may be delegated to the REH's registered
pharmacist or other qualified individual.
(a) Standard: Pharmacy management and administration. The pharmacy
or drug storage area must be administered in accordance with accepted
professional principles and in accordance with state and Federal laws.
(1) A pharmacist or competent individual in accordance with state
scope of practice laws must be responsible for developing, supervising,
and coordinating all the activities of the pharmacy services. The
pharmacist or competent individual in accordance with state law and
scope of practice must be available for a sufficient time to provide
oversight of the REH's pharmacy services based on the scope and
complexity of the services offered at the REH.
(2) The pharmaceutical service must have an adequate number of
personnel to ensure quality pharmaceutical services for the provision
of all services provided by the REH.
(3) Current and accurate records must be kept of the receipt and
disposition of all scheduled drugs.
(b) Standard: Delivery of services. Drugs and biologicals must be
controlled and distributed in accordance with applicable standards of
practice, consistent with Federal and state law, to ensure patient
safety.
(1) All compounding, packaging, and dispensing of drugs must be
done by a licensed pharmacist or a licensed physician, or under the
supervision of a pharmacist or competent individual in accordance with
state law and scope of practice and performed consistent with state and
Federal laws.
(2) All drugs and biologicals must be kept in a secure area, and
locked when appropriate.
(i) All drugs listed in Schedules II, III, IV, and V of the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
801 et seq.) must be kept locked within a secure area.
(ii) Only authorized personnel may have access to locked areas.
(3) Outdated, mislabeled, or otherwise unusable drugs and
biologicals must not be available for patient use.
(4) Drugs and biologicals must be removed from the pharmacy or
storage area only by personnel designated in the policies of the
medical staff and pharmaceutical service, in accordance with Federal
and state law.
(c) Standard: Administration of drugs. Drugs must be prepared and
administered according to established policies and acceptable standards
of practice.
(1) Adverse reactions must be reported to the physician responsible
for the patient and must be documented in the record.
(2) Blood transfusions, blood products, and intravenous medications
must be administered in accordance with state law and approved medical
staff policies and procedures.
(3) Orders given orally for drugs and biologicals must be followed
by a written order, signed by the prescribing physician or other
authorized prescriber.
(4) There must be an REH procedure for reporting transfusion
reactions, adverse drug reactions, and errors in administration of
drugs.
Sec. 485.524 Condition of participation: Additional outpatient
medical and health services.
If the REH provides outpatient medical and health services in
addition to providing emergency services and observation care, the
medical and health services must be appropriately organized and meet
the needs of the patients in accordance with acceptable standards of
practice.
(a) Standard: Patient services. The REH may provide outpatient and
medical health diagnostic and therapeutic items and services that are
commonly furnished in a physician's office or at another entry point
into the health care delivery system that include, but are not limited
to, radiology, laboratory, outpatient rehabilitation, surgical,
maternal health, and behavioral health services. If the REH provides
outpatient and medical health diagnostic and therapeutic items and
services, those items and services must align with the health needs of
the community served by the REH. If the REH provides outpatient medical
and health services in addition to providing emergency services, the
REH must--
(1) Provide items and services based on nationally recognized
guidelines and standards of practice.
(2) Have a system in place for referral from the REH to different
levels of care, including follow-up care, as appropriate.
(3) Have effective communication systems in place between the REH
and the patient (or responsible individual) and their family, ensuring
that the REH is responsive to their needs and preferences.
(4) Have established relationships with hospitals that have the
resources and capacity available to deliver care that is beyond the
scope of care delivered at the REH.
(5) Have personnel providing the services in paragraphs (a)(1)
through (4) of this section who meet the requirements in paragraph (b)
of this section.
(b) Standard: Personnel for additional outpatient and medical
health services. The REH must--
(1) Assign one or more individuals to be responsible for outpatient
services.
[[Page 40392]]
(2) Have appropriate professional and nonprofessional personnel
available at each location where outpatient services are offered, based
on the scope and complexity of outpatient services.
(3) For any specialty services offered at the REH, have a doctor of
medicine or osteopathy, nurse practitioner, clinical nurse specialist,
or physician assistant providing services with experience and training
in the specialty service area and in accordance with their scope of
practice.
(c) Standard: Orders for outpatient medical and health services.
Outpatient medical and health services must be ordered by a
practitioner who meets the following conditions:
(1) Is responsible for the care of the patient.
(2) Is licensed in the state where they provide care to the
patient.
(3) Is acting within their scope of practice under state law.
(4) Is authorized in accordance with state law and policies adopted
by the medical staff, and approved by the governing body, to order the
applicable outpatient services. This applies to the following:
(i) All practitioners who are appointed to the REH's medical staff
and who have been granted privileges to order the applicable outpatient
services.
(ii) All practitioners not appointed to the medical staff, but who
satisfy the requirements of paragraphs (c)(1) through (4) of this
section for authorization by the medical staff and the REH for ordering
the applicable outpatient services for their patients.
(d) Standard: Surgical services. If the REH provides outpatient
surgical services, surgical procedures must be performed in a safe
manner by qualified practitioners who have been granted clinical
privileges by the governing body, or responsible individual, of the REH
in accordance with the designation requirements under paragraph (a) of
this section.
(1) Designation of qualified practitioners. The REH designates the
practitioners who are allowed to perform surgery for REH patients, in
accordance with its approved policies and procedures, and with state
scope of practice laws. Surgery is performed only by--
(i) A doctor of medicine or osteopathy, including an osteopathic
practitioner recognized under section 1101(a)(7) of the Act;
(ii) A doctor of dental surgery or dental medicine; or
(iii) A doctor of podiatric medicine.
(2) Anesthetic risk and evaluation. (i) A qualified practitioner,
as specified in paragraph (a) of this section, must examine the patient
immediately before surgery to evaluate the risk of the procedure to be
performed.
(ii) A qualified practitioner, as specified in paragraph (d)(3) of
this section, must examine each patient before surgery to evaluate the
risk of anesthesia.
(iii) Before discharge from the REH, each patient must be evaluated
for proper anesthesia recovery by a qualified practitioner, as
specified in paragraph (d)(3) of this section.
(3) Administration of anesthesia. The REH designates the person who
is allowed to administer anesthesia to REH patients in accordance with
its approved policies and procedures and with state scope-of-practice
laws.
(i) Anesthesia must be administered by only--
(A) A qualified anesthesiologist;
(B) A doctor of medicine or osteopathy other than an
anesthesiologist; including an osteopathic practitioner recognized
under section 1101(a)(7) of the Act;
(C) A doctor of dental surgery or dental medicine;
(D) A doctor of podiatric medicine;
(E) A certified registered nurse anesthetist (CRNA), as defined in
Sec. 410.69(b) of this chapter;
(F) An anesthesiologist's assistant, as defined in Sec. 410.69(b)
of this chapter; or
(G) A supervised trainee in an approved educational program, as
described in Sec. 413.85 or Sec. Sec. 413.76 through 413.83 of this
chapter.
(ii) In those cases in which a CRNA administers the anesthesia, the
anesthetist must be under the supervision of the operating practitioner
except as provided in paragraph (e) of this section. An
anesthesiologist's assistant who administers anesthesia must be under
the supervision of an anesthesiologist.
(4) Discharge. All patients are discharged in the company of a
responsible adult, except those exempted by the practitioner who
performed the surgical procedure.
(5) Standard: State exemption. (i) An REH may be exempted from the
requirement for physician supervision of CRNAs as described in
paragraph (d)(3) of this section, if the state in which the REH is
located submits a letter to CMS signed by the Governor, following
consultation with the State's Boards of Medicine and Nursing,
requesting exemption from physician supervision for CRNAs. The letter
from the Governor must attest that they have consulted with the State
Boards of Medicine and Nursing about issues related to access to and
the quality of anesthesia services in the state and has concluded that
it is in the best interests of the state's citizens to opt-out of the
current physician supervision requirement, and that the opt-out is
consistent with state law.
(ii) The request for exemption and recognition of state laws and
the withdrawal of the request may be submitted at any time, and are
effective upon submission.
Sec. 485.526 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
The REH must have active facility-wide programs for the
surveillance, prevention, and control of healthcare-associated
infections (HAIs) and other infectious diseases, and for the
optimization of antibiotic use through stewardship. The programs must
demonstrate adherence to nationally recognized infection prevention and
control guidelines, as well as to best practices for improving
antibiotic use where applicable, and for reducing the development and
transmission of HAIs and antibiotic-resistant organisms. Infection
prevention and control problems and antibiotic use issues identified in
the programs must be addressed in collaboration with the facility-wide
quality assessment and performance improvement (QAPI) program.
(a) Standard: Infection prevention and control program organization
and policies. The REH must demonstrate that:
(1) An individual (or individuals), who is qualified through
education, training, experience, or certification in infection
prevention and control, is appointed by the governing body, or
responsible individual, as the infection preventionist(s)/infection
control professional(s) responsible for the infection prevention and
control program and that the appointment is based on the
recommendations of medical staff leadership and nursing leadership;
(2) The infection prevention and control program, as documented in
its policies and procedures, employs methods for preventing and
controlling the transmission of infections within the REH and between
the REH and other health care settings;
(3) The infection prevention and control program include
surveillance, prevention, and control of HAIs, including maintaining a
clean and sanitary environment to avoid sources and transmission of
infection, and that the program also addresses any infection control
issues identified by public health authorities; and
[[Page 40393]]
(4) The infection prevention and control program reflects the scope
and complexity of the services furnished by the REH.
(b) Standard: Antibiotic stewardship program organization and
policies. The REH must demonstrate that--
(1) An individual (or individuals), who is qualified through
education, training, or experience in infectious diseases and/or
antibiotic stewardship, is appointed by the governing body, or
responsible individual, as the leader(s) of the antibiotic stewardship
program and that the appointment is based on the recommendations of
medical staff leadership and pharmacy leadership;
(2) The facility-wide antibiotic stewardship program:
(i) Demonstrates coordination among all components of the REH
responsible for antibiotic use and resistance, including, but not
limited to, the infection prevention and control program, the QAPI
program, the medical staff, nursing services, and pharmacy services;
(ii) Documents the evidence-based use of antibiotics in all
departments and services of the REH; and
(iii) Documents any improvements, including sustained improvements,
in proper antibiotic use;
(3) The antibiotic stewardship program adheres to nationally
recognized guidelines, as well as best practices, for improving
antibiotic use; and
(4) The antibiotic stewardship program reflects the scope and
complexity of the services furnished by an REH.
(c) Standard: Leadership responsibilities. (1) The governing body,
or responsible individual, must ensure all of the following:
(i) Systems are in place and operational for the tracking of all
infection surveillance, prevention and control, and antibiotic use
activities, in order to demonstrate the implementation, success, and
sustainability of such activities.
(ii) All HAIs and other infectious diseases identified by the
infection prevention and control program as well as antibiotic use
issues identified by the antibiotic stewardship program are addressed
in collaboration with the REH's QAPI leadership.
(2) The infection prevention and control professional(s) are
responsible for:
(i) The development and implementation of facility-wide infection
surveillance, prevention, and control policies and procedures that
adhere to nationally recognized guidelines.
(ii) All documentation, written or electronic, of the infection
prevention and control program and its surveillance, prevention, and
control activities.
(iii) Communication and collaboration with the REH's QAPI program
on infection prevention and control issues.
(iv) Competency-based training and education of REH personnel and
staff, including medical staff, and, as applicable, personnel providing
contracted services in the REH, on the practical applications of
infection prevention and control guidelines, policies and procedures.
(v) The prevention and control of HAIs, including auditing of
adherence to infection prevention and control policies and procedures
by REH personnel.
(vi) Communication and collaboration with the antibiotic
stewardship program.
(3) The leader(s) of the antibiotic stewardship program is
responsible for:
(i) The development and implementation of a facility-wide
antibiotic stewardship program, based on nationally recognized
guidelines, to monitor and improve the use of antibiotics.
(ii) All documentation, written or electronic, of antibiotic
stewardship program activities.
(iii) Communication and collaboration with medical staff, nursing,
and pharmacy leadership, as well as the REH's infection prevention and
control and QAPI programs, on antibiotic use issues.
(iv) Competency-based training and education of REH personnel and
staff, including medical staff, and, as applicable, personnel providing
contracted services in the REH, on the practical applications of
antibiotic stewardship guidelines, policies, and procedures.
(d) Standard: Unified and integrated infection prevention and
control and antibiotic stewardship programs for multi-facility systems.
If a REH is part of a system consisting of multiple separately
certified hospitals, CAHs, and/or REHs using a system governing body
that is legally responsible for the conduct of two or more hospitals,
CAHs, and/or REHs, the system governing body can elect to have unified
and integrated infection prevention and control and antibiotic
stewardship programs for all of its member facilities after determining
that such a decision is in accordance with all applicable state and
local laws. The system governing body is responsible and accountable
for ensuring that each of its separately certified REHs meets all of
the requirements of this section. Each separately certified REH subject
to the system governing body must demonstrate that:
(1) The unified and integrated infection prevention and control and
antibiotic stewardship programs are established in a manner that takes
into account each member REH's unique circumstances and any significant
differences in patient populations and services offered in each REH;
(2) The unified and integrated infection prevention and control and
antibiotic stewardship programs establish and implement policies and
procedures to ensure that the needs and concerns of each of its
separately certified REHs, regardless of practice or location, are
given due consideration;
(3) The unified and integrated infection prevention and control and
antibiotic stewardship programs have mechanisms in place to ensure that
issues localized to particular REHs are duly considered and addressed;
and
(4) A qualified individual (or individuals) with expertise in
infection prevention and control and in antibiotic stewardship has been
designated at the REH as responsible for communicating with the unified
infection prevention and control and antibiotic stewardship programs,
for implementing and maintaining the policies and procedures governing
infection prevention and control and antibiotic stewardship as directed
by the unified infection prevention and control and antibiotic
stewardship programs, and for providing education and training on the
practical applications of infection prevention and control and
antibiotic stewardship to REH staff.
(e) COVID-19 and Seasonal Influenza reporting. Beginning at the
conclusion of the COVID-19 Public Health Emergency, as defined in Sec.
400.200 of this chapter, and continuing until April 30, 2024, except
when the Secretary specifies an earlier end date for the requirements
of this paragraph (e), the REH must electronically report information
about COVID-19 and seasonal influenza in a standardized format
specified by the Secretary.
(1) Related to COVID-19, to the extent as required by the
Secretary, this report must include the following data elements:
(i) Suspected and confirmed COVID-19 infections among patients and
staff.
(ii) Total COVID-19 deaths among patients and staff.
(iii) Personal protective equipment and testing supplies.
(iv) Ventilator use, capacity, and supplies.
(v) Total patient census and capacity.
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(vi) Staffing shortages.
(vii) COVID-19 vaccine administration data of patients and staff.
(viii) Relevant therapeutic inventories or usage, or both.
(2) Related to seasonal influenza, to the extent as required by the
Secretary, this report must include the following data elements:
(i) Confirmed influenza infections among patients and staff.
(ii) Total influenza deaths among patients and staff.
(iii) Confirmed co-morbid influenza and COVID-19 infections among
patients and staff.
(f) Standard: Reporting of data related to viral and bacterial
pathogens and infectious diseases of pandemic or epidemic potential.
The REH must electronically report information on Acute Respiratory
Illness (including, but not limited to, Seasonal Influenza Virus,
Influenza-like Illness, and Severe Acute Respiratory Infection), SARS-
CoV-2/COVID-19, and other viral and bacterial pathogens and infectious
diseases of pandemic or epidemic potential only when the Secretary has
declared a Public Health Emergency (PHE), as defined in Sec. 400.200
of this chapter, directly related to such specific pathogens and
infectious diseases. The requirements of this paragraph (f) will be
applicable to local, state, regional, or national PHEs as declared by
the Secretary.
(1) The REH must electronically report information about the
infectious disease pathogen, relevant to the declared PHE, in a
standardized format specified by the Secretary. To the extent as
required by the Secretary, this report must include, the following:
(i) Suspected and confirmed infections of the relevant infectious
disease pathogen among patients and staff.
(ii) Total deaths attributed to the relevant infectious disease
pathogen among patients and staff.
(iii) Personal protective equipment and other relevant supplies in
the REH.
(iv) Capacity and supplies in the REH relevant to the immediate and
long term treatment of the relevant infectious disease pathogen, such
as ventilator and dialysis/continuous renal replacement therapy
capacity and supplies.
(v) Total patient census, capacity, and capability.
(vi) Staffing shortages.
(vii) Vaccine administration data of patients and staff for
conditions monitored under this section and where a specific vaccine is
applicable.
(viii) Relevant therapeutic inventories or usage, or both.
(ix) Isolation capacity, including airborne isolation capacity.
(x) Key co-morbidities or exposure risk factors, or both, of
patients being treated for the pathogen or disease of interest in this
section that are captured with interoperable data standards and
elements.
(2) Unless the Secretary specifies an alternative format by which
the REH must report these data elements, the REH must report the
applicable infection (confirmed and suspected) and vaccination data in
a format that provides person-level information, which must include
medical record identifier, race, ethnicity, age, sex, residential
county and zip code, and relevant comorbidities for affected patients.
Facilities must not report any directly or potentially individually-
identifiable information for affected patients (for example, name,
social security number) that is not set out in this section or
otherwise specified by the Secretary.
(3) The REH must provide the information specified in this
paragraph (f) on a daily basis, unless the Secretary specifies a lesser
frequency, to the Centers for Disease Control and Prevention's (CDC)
National Healthcare Safety Network or other CDC-supported surveillance
systems as determined by the Secretary.
(g) Standard: COVID-19 Vaccination of REH staff. Until November 4,
2024, unless the Secretary specifies an earlier end date for the
requirements of this paragraph (g), the REH must develop and implement
policies and procedures to ensure that all staff are fully vaccinated
for COVID-19. For purposes of this section, staff are considered fully
vaccinated if it has been 2 weeks or more since they completed a
primary vaccination series for COVID-19. The completion of a primary
vaccination series for COVID-19 is defined here as the administration
of a single-dose vaccine, or the administration of all required doses
of a multi-dose vaccine.
(1) Regardless of clinical responsibility or patient contact, the
policies and procedures must apply to the following REH staff, who
provide any care, treatment, or other services for the REH and/or its
patients:
(i) REH employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for
the REH and/or its patients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the
following REH staff:
(i) Staff who exclusively provide telehealth or telemedicine
services outside of the REH setting and who do not have any direct
contact with patients and other staff specified in paragraph (f)(1) of
this section; and
(ii) Staff who provide support services for the REH that are
performed exclusively outside of the REH setting and who do not have
any direct contact with patients and other staff specified in paragraph
(f)(1) of this section.
(3) The policies and procedures must include, at a minimum, the
following components:
(i) A process for ensuring all staff specified in paragraph (f)(1)
of this section (except for those staff who have pending requests for,
or who have been granted, exemptions to the vaccination requirements of
this section, or those staff for whom COVID-19 vaccination must be
temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations) have received, at a minimum, a single-
dose COVID-19 vaccine, or the first dose of the primary vaccination
series for a multi-dose COVID-19 vaccine prior to staff providing any
care, treatment, or other services for the REH and/or its patients;
(ii) A process for ensuring that all staff specified in paragraph
(f)(1) of this section are fully vaccinated for COVID-19, except for
those staff who have been granted exemptions to the vaccination
requirements of this section, or those staff for whom COVID-19
vaccination must be temporarily delayed, as recommended by the CDC, due
to clinical precautions and considerations;
(iii) A process for ensuring the implementation of additional
precautions, intended to mitigate the transmission and spread of COVID-
19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19
vaccination status of all staff specified in paragraph (f)(1) of this
section;
(v) A process for tracking and securely documenting the COVID-19
vaccination status of any staff who have obtained any booster doses as
recommended by the CDC;
(vi) A process by which staff may request an exemption from the
staff COVID-19 vaccination requirements based on an applicable Federal
law;
(vii) A process for tracking and securely documenting information
provided by those staff who have requested, and for whom the REH has
granted, an exemption from the staff COVID-19 vaccination requirements
based on recognized clinical contraindications or applicable Federal
laws;
[[Page 40395]]
(viii) A process for ensuring that all documentation, which
confirms recognized clinical contraindications to COVID-19 vaccines and
which supports staff requests for medical exemptions from vaccination,
has been signed and dated by a licensed practitioner, who is not the
individual requesting the exemption, and who is acting within their
respective scope of practice as defined by, and in accordance with, all
applicable state and local laws, and for further ensuring that such
documentation contains:
(A) All information specifying which of the authorized COVID-19
vaccines are clinically contraindicated for the staff member to receive
and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending
that the staff member be exempted from the REH's COVID-19 vaccination
requirements for staff based on the recognized clinical
contraindications;
(ix) A process for ensuring the tracking and secure documentation
of the vaccination status of staff for whom COVID-19 vaccination must
be temporarily delayed, as recommended by the CDC, due to clinical
precautions and considerations, including, but not limited to,
individuals with acute illness secondary to COVID-19, and individuals
who received monoclonal antibodies or convalescent plasma for COVID-19
treatment; and
(x) Contingency plans for staff who are not fully vaccinated for
COVID-19.
Sec. 485.528 Condition of participation: Staffing and staff
responsibilities.
(a) Standard: Emergency department staffing. The emergency
department of the REH must be staffed 24 hours a day, 7 days a week to
receive patients and activate the appropriate medical resources.
(b) Standard: Staffing. (1) The REH must have a professional health
care staff that includes one or more doctors of medicine or osteopathy,
and may include one or more physician assistants, nurse practitioners,
or clinical nurse specialists.
(2) Any ancillary personnel are supervised by the professional
staff.
(3) The staff is sufficient to provide the services essential to
the operation of the REH.
(4) A registered nurse, clinical nurse specialist, or licensed
practical nurse is on duty whenever the REH has one or more patients
receiving emergency care or observation care.
(c) Standard: Responsibilities of the doctor of medicine or
osteopathy. (1) The doctor of medicine or osteopathy must--
(i) Provide medical direction for the REH's health care activities
and consultation for, and medical supervision of, the health care
staff.
(ii) In conjunction with the physician assistant and/or nurse
practitioner member(s), participate in developing, executing, and
periodically reviewing the REH's written policies governing the
services it furnishes.
(iii) In conjunction with the physician assistant and/or nurse
practitioner members, periodically review the REH's patient records,
provide medical orders, and provide medical care services to the
patients of the REH.
(iv) Periodically review and sign a sample of outpatient records of
patients cared for by nurse practitioners, clinical nurse specialists,
certified nurse midwives, or physician assistants only to the extent
where state law requires record reviews or co-signatures, or both, by a
collaborating physician.
(2) A doctor of medicine or osteopathy must be present for
sufficient periods of time to provide medical direction, consultation,
and supervision for the services provided in the REH, and is available
through direct radio or telephone communication or electronic
communication for consultation, assistance with medical emergencies, or
patient referral.
(d) Standard: Physician assistant, nurse practitioner, and clinical
nurse specialist responsibilities. (1) The physician assistant, the
nurse practitioner, or clinical nurse specialist members of the REH's
staff must--
(i) Participate in the development, execution and periodic review
of the written policies governing the services the REH furnishes; and
(ii) Participate with a doctor of medicine or osteopathy in a
periodic review of the patients' health records.
(2) The physician assistant, nurse practitioner, or clinical nurse
specialist performs the following functions to the extent they are not
being performed by a doctor of medicine or osteopathy:
(i) Provides services in accordance with the REH's policies.
(ii) Arranges for, or refers patients to, needed services that
cannot be furnished at the REH, and assures that adequate patient
health records are maintained and transferred as required when patients
are referred.
(3) Whenever a patient is placed in observation care at the REH by
a nurse practitioner, physician assistant, or clinical nurse
specialist, a doctor of medicine or osteopathy on the staff of the REH
is notified of the patient's status.
(e) Standard: Periodic review of clinical privileges and
performance. The REH requires that--
(1) The quality and appropriateness of the diagnosis and treatment
furnished by nurse practitioners, clinical nurse specialists, and
physician assistants at the REH must be evaluated by a member of the
REH staff who is a doctor of medicine or osteopathy or by another
doctor of medicine or osteopathy under contract with the REH.
(2) The quality and appropriateness of the diagnosis and treatment
furnished by doctors of medicine or osteopathy at the REH must be
evaluated by one of the following--
(i) One Quality Improvement Organization (QIO) or equivalent
entity.
(ii) In the case of distant-site physicians and practitioners
providing telemedicine services to the REH's patient under an agreement
between the REH and a distant-site hospital, the distant-site hospital;
or
(iii) In the case of distant-site physicians and practitioners
providing telemedicine services to the REH's patients under a written
agreement between the REH and a distant-site telemedicine entity, one
Quality Improvement Organization (QIO) or equivalent entity.
(3) The REH staff consider the findings of the evaluation and make
the necessary changes as specified in paragraphs (b) through (d) of
this section.
Sec. 485.530 Condition of participation: Nursing services.
The REH must have an organized nursing service that is available to
provide 24-hour nursing services for the provision of patient care. The
nursing services must be furnished and supervised by a registered
nurse. Nursing services must meet the needs of patients.
(a) Standard: Organization and staffing. Patient care
responsibilities must be delineated for all nursing service personnel.
Nursing services must be provided in accordance with recognized
standards of practice.
(b) Standard: Nursing leadership. The director of the nursing
service must be a licensed registered nurse. The individual is
responsible for the operation of the service, including determining the
types and numbers of nursing personnel and staff necessary to provide
nursing care for all areas of the REH.
Sec. 485.532 Condition of participation: Discharge planning.
An REH must have an effective discharge planning process that
focuses
[[Page 40396]]
on the patient's goals and treatment preferences and includes the
patient and their 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 their treatment preferences, ensure an effective
transition of the patient from the REH to post-discharge care, and
reduce the factors leading to preventable hospital admissions or
readmissions.
(a) Standard: Discharge planning process. The REH's discharge
planning process must identify, at an early stage of the provision of
services, 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-REH 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 services following those
furnished by the REH, including, but not limited to, hospice care
services, post-REH 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 REH 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 (a) must be developed by, or under the supervision
of, a registered nurse, social worker, or other appropriately qualified
personnel.
(6) The REH'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 REH must assess its discharge planning process on a regular
basis. The assessment must include ongoing periodic review of a
representative sample of discharge plans.
(8) The REH 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, skilled nursing
facility (SNF), inpatient rehabilitation facility (IRF), or long-term
care hospital (LTCH) data on quality measures and data on resource use
measures. The REH 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 REH
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.
Sec. 485.534 Condition of participation: Patient's rights.
An REH must protect and promote each patient's rights.
(a) Standard: Notice of rights. (1) An REH must inform each
patient, or when appropriate, the patient's representative (as allowed
under state law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible.
(2) The REH must establish a process for prompt resolution of
patient grievances and must inform each patient whom to contact to file
a grievance. The REH's governing body or responsible individual must
approve and be responsible for the effective operation of the grievance
process and must review and resolve grievances, unless it delegates the
responsibility in writing to a grievance committee. The grievance
process must include a mechanism for timely referral of patient
concerns regarding quality of care or premature discharge to the
appropriate Utilization and Quality Control Quality Improvement
Organization. At a minimum:
(i) The REH must establish a clearly explained procedure for the
submission of a patient's written or verbal grievance to the REH.
(ii) The grievance process must specify time frames for review of
the grievance and the provision of a response.
(iii) In its resolution of the grievance, the REH must provide the
patient with written notice of its decision that contains the name of
the REH contact person, the steps taken on behalf of the patient to
investigate the grievance, the results of the grievance process, and
the date of completion.
(b) Standard: Exercise of rights. The patient has the right to--
(1) Participate in the development and implementation of their plan
of care.
(2) Make informed decisions regarding their care, including being
informed of their health status, and being able to request or refuse
treatment. This right must not be construed as a mechanism to demand
the provision of treatment or services deemed medically unnecessary or
inappropriate.
(3) Formulate advance directives and to have REH staff and
practitioners who provide care in the REH comply with these directives,
in accordance with Sec. Sec. 489.100, 489.102, and 489.104 of this
chapter.
(c) Standard: Privacy and safety. The patient has the right to--
(1) Personal privacy.
(2) Receive care in a safe setting.
(3) Be free from all forms of abuse or harassment.
(d) Standard: Confidentiality of patient records. (1) The patient
has the right to the confidentiality of their medical records.
(2) The patient has the right to access their medical records,
including current medical records, upon an oral or written request.
(i) The records must be provided in the form and format requested
by the individual, if it is readily producible in such form and format.
This includes 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.
(ii) The records must be provided within a reasonable time frame.
The REH 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 recordkeeping system permits.
(e) Standard: Restraint or seclusion. All patients have the right
to be free from physical or mental abuse, and corporal punishment. All
patients have the right to be free from restraint or
[[Page 40397]]
seclusion, of any form, imposed as a means of coercion, discipline,
convenience, or retaliation by staff. Restraint or seclusion may only
be imposed to ensure the immediate physical safety of the patient, a
staff member, or others and must be discontinued at the earliest
possible time.
(1)(i) A restraint is--
(A) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces the ability of a patient to move
their arms, legs, body, or head freely; or
(B) A drug or medication when it is used as a restriction to manage
the patient's behavior or restrict the patient's freedom of movement
and is not a standard treatment or dosage for the patient's condition.
(C) A restraint does not include devices, such as orthopedically
prescribed devices, surgical dressings or bandages, protective helmets,
or other methods that involve the physical holding of a patient for the
purpose of conducting routine physical examinations or tests, or to
protect the patient from falling out of bed, off of a stretcher, or out
of a chair, or to permit the patient to participate in activities
without the risk of physical harm (this does not include a physical
escort).
(ii) Seclusion is the involuntary confinement of a patient alone in
a room or area from which the patient is physically prevented from
leaving. Seclusion may only be used for the management of violent or
self-destructive behavior.
(2) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
patient, a staff member or others from harm.
(3) The type or technique of restraint or seclusion used must be
the least restrictive intervention that will be effective to protect
the patient, a staff member, or others from harm.
(4) The REH must have written policies and procedures regarding the
use of restraint and seclusion that are consistent with current
standards of practice.
(f) Standard: Restraint or seclusion: Staff training requirements.
The patient has the right to safe implementation of restraint or
seclusion by trained staff.
(1) The REH must provide patient-centered competency-based training
and education of REH personnel and staff, including medical staff, and,
as applicable, personnel providing contracted services in the REH, on
the use of restraint and seclusion.
(2) The training must include alternatives to the use of restraint/
seclusion.
(g) Standard: Death reporting requirements. REHs must report deaths
associated with the use of seclusion or restraint.
(1) With the exception of deaths described under paragraph (g)(2)
of this section, the REH must report the following information to CMS
by telephone, facsimile, or electronically, as determined by CMS, no
later than the close of business on the next business day following
knowledge of the patient's death:
(i) Each death that occurs while a patient is in restraint or
seclusion.
(ii) Each death that occurs within 24 hours after the patient has
been removed from restraint or seclusion.
(iii) Each death known to the REH that occurs within 1 week after
restraint or seclusion where it is reasonable to assume that use of
restraint or placement in seclusion contributed directly or indirectly
to a patient's death, regardless of the type(s) of restraint used on
the patient during this time. ``Reasonable to assume'' in this context
includes, but is not limited to, deaths related to restrictions of
movement for prolonged periods of time, or death related to chest
compression, restriction of breathing, or asphyxiation.
(2) When no seclusion has been used and when the only restraints
used on the patient are those applied exclusively to the patient's
wrist(s), and which are composed solely of soft, non-rigid, cloth-like
materials, the REH staff must record in an internal log or other
system, the following information:
(i) Any death that occurs while a patient is in such restraints.
(ii) Any death that occurs within 24 hours after a patient has been
removed from such restraints.
(3) The staff must document in the patient's medical record the
date and time the death was:
(i) Reported to CMS for deaths described in paragraph (g)(1) of
this section; or
(ii) Recorded in the internal log or other system for deaths
described in paragraph (g)(2) of this section.
(4) For deaths described in paragraph (g)(2) of this section,
entries into the internal log or other system must be documented as
follows:
(i) Each entry must be made not later than seven days after the
date of death of the patient.
(ii) Each entry must document the patient's name, date of birth,
date of death, name of attending physician or other licensed
practitioner who is responsible for the care of the patient, medical
record number, and primary diagnosis(es).
(iii) The information must be made available in either written or
electronic form to CMS immediately upon request.
(h) Standard: Patient visitation rights. An REH must have written
policies and procedures regarding the visitation rights of patients,
including those setting forth any clinically necessary or reasonable
restriction or limitation that the REH may need to place on such rights
and the reasons for the clinical restriction or limitation. An REH must
meet the following requirements:
(1) Inform each patient (or support person, where appropriate) of
their visitation rights, including any clinical restriction or
limitation on such rights, when they are informed of their other rights
under this section.
(2) Inform each patient (or support person, where appropriate) of
the right, subject to their consent, to receive the visitors whom they
designate, including, but not limited to, a spouse, a domestic partner
(including a same-sex domestic partner), another family member, or a
friend, and their right to withdraw or deny such consent at any time.
(3) Not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation
privileges consistent with patient preferences.
Sec. 485.536 Condition of participation: Quality assessment and
performance improvement program.
The REH must develop, implement, and maintain an effective,
ongoing, REH-wide, data-driven quality assessment and performance
improvement (QAPI) program. The REH's governing body must ensure that
the program reflects the complexity of the REH's organization and
services; involves all REH departments and services (including those
services furnished under contract or arrangement); and focuses on
indicators related to improved health outcomes and the prevention and
reduction of medical errors. The REH must maintain and demonstrate
evidence of its QAPI program for review by CMS.
(a) Standard: Program scope. (1) The program must include, but not
be limited to, an ongoing program that shows measurable improvement in
indicators for which there is evidence that it will improve health
outcomes and identify and reduce medical errors.
[[Page 40398]]
(2) The REH must measure, analyze, and track quality indicators,
including adverse patient events, and other aspects of performance that
assess processes of care, REH service and operations.
(b) Standard: Program data collection and analysis. The program
must incorporate quality indicator data including patient care data,
and other relevant data, in order to achieve the goals of the QAPI
program.
(c) Standard: Program activities. (1) The REH must set priorities
for its performance improvement activities that--
(i) Focus on high-risk, high-volume, or problem-prone areas;
(ii) Consider the incidence, prevalence, and severity of problems
in those areas; and
(iii) Affect health outcomes, patient safety, and quality of care.
(2) Performance improvement activities must track medical errors
and adverse patient events, analyze their causes, and implement
preventive actions and mechanisms that include feedback and learning
throughout the REH. An adverse patient event means an untoward,
undesirable, and usually unanticipated event that causes death or
serious injury or the risk thereof. Medical error means an error that
occurs in the delivery of health care services.
(3) The REH must take actions aimed at performance improvement and,
after implementing those actions, the REH must measure its success, and
track performance to ensure that improvements are sustained.
(d) Standard: Executive responsibilities. The REH's governing body
(or organized group or individual who assumes full legal authority and
responsibility for operations of the REH), medical staff, and
administrative officials are responsible and accountable for ensuring
the following:
(1) That an ongoing program for quality improvement and patient
safety, including the reduction of medical errors, is defined,
implemented, and maintained.
(2) That the REH-wide quality assessment and performance
improvement efforts address priorities for improved quality of care and
patient safety; and that all improvement actions are evaluated.
(3) That clear expectations for safety are established.
(4) That adequate resources are allocated for measuring, assessing,
improving, and sustaining the REH's performance and reducing risk to
patients.
(e) Standard: Unified and integrated QAPI program for an REH in a
multi-facility system. If an REH is part of a system consisting of
multiple separately certified hospitals, CAHs, and/or REHs using a
system governing body that is legally responsible for the conduct of
two or more hospitals, CAHs, and/or REHs, the system governing body can
elect to have a unified and integrated QAPI program for all of its
member facilities after determining that such a decision is in
accordance with all applicable state and local laws. The system
governing body is responsible and accountable for ensuring that each of
its separately certified REHs meets all of the requirements of this
section. Each separately certified REH subject to the system governing
body must demonstrate that--
(1) The unified and integrated QAPI program is established in a
manner that takes into account each member REH's unique circumstances
and any significant differences in patient populations and services
offered in each REH; and
(2) The unified and integrated QAPI program establishes and
implements policies and procedures to ensure that the needs and
concerns of each of its separately certified REHs, regardless of
practice or location, are given due consideration, and that the unified
and integrated QAPI program has mechanisms in place to ensure that
issues localized to particular REHs are duly considered and addressed.
Sec. 485.538 Condition of participation: Agreements.
The REH must have in effect an agreement with at least one
certified hospital that is a level I or level II trauma center for the
referral and transfer of patients requiring emergency medical care
beyond the capabilities of the REH that is--
(a) Licensed as a hospital in a state that provides for the
licensing of hospitals under state or applicable local law or approved
by the agency of such state or locality responsible for licensing
hospitals, as meeting standards established for licensing established
by the agency of the state; and
(b) Licensed or designated by the state or local government
authority as level I or level II trauma center or is verified by the
American College of Surgeons as a level I or level II trauma center.
Sec. 485.540 Condition of participation: Medical records.
(a) Standard: Records system. (1) The REH must maintain a medical
records system in accordance with written policies and procedures.
(2) The records must be legible, complete, accurately documented,
readily accessible, and systematically organized.
(3) A designated member of the professional staff is responsible
for maintaining the records and for ensuring that they are completely
and accurately documented, readily accessible, and systematically
organized.
(4) For each patient receiving health care services, the REH must
maintain a record that includes, as applicable--
(i) Identification and social data, evidence of properly executed
informed consent forms, pertinent medical history, assessment of the
health status and health care needs of the patient, and a brief summary
of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory
test results, including clinical laboratory services, and consultative
findings;
(iii) All orders of doctors of medicine or osteopathy or other
practitioners, reports of treatments and medications, nursing notes and
documentation of complications, and other pertinent information
necessary to monitor the patient's progress, such as temperature
graphics, progress notes describing the patient's response to
treatment; and
(iv) Dated signatures of the doctor of medicine or osteopathy or
other health care professional.
(b) Standard: Protection of record information. (1) The REH must
maintain the confidentiality of record information and provides
safeguards against loss, destruction, or unauthorized use.
(2) The REH must have written policies and procedures that govern
the use and removal of records from the REH and the conditions for the
release of information.
(3) The patient's written consent is required for release of
information not required by law.
(c) Standard: Retention of records. The records must be retained
for at least 5 years from date of last entry, and longer if required by
state statute, or if the records may be needed in any pending
proceeding.
(d) Standard: Electronic notifications. If the REH utilizes an
electronic medical records system or other electronic administrative
system, which is conformant with the content exchange standard at 45
CFR 170.205(d)(2), then the REH must demonstrate that--
(1) The system's notification capacity is fully operational and the
REH uses it in accordance with all state and Federal statutes and
regulations applicable to the REH's exchange of patient health
information.
[[Page 40399]]
(2) The system sends notifications that must include at least
patient name, treating practitioner name, and sending institution name.
(3) To the extent permissible under applicable Federal and state
law and regulations, and not inconsistent with the patient's expressed
privacy preferences, the system sends notifications directly, or
through an intermediary that facilitates exchange of health
information, at the time of the patient's registration in the REH's
emergency department.
(4) To the extent permissible under applicable Federal and state
law and regulations, and not inconsistent with the patient's expressed
privacy preferences, the system sends notifications directly, or
through an intermediary that facilitates exchange of health
information, either immediately prior to, or at the time the patient's
discharge or transfer from the REH's emergency department.
(5) The REH has made a reasonable effort to ensure that the system
sends the notifications to all applicable post-acute care services
providers and suppliers, as well as to any of the following
practitioners and entities, which need to receive notification of the
patient's status for treatment, care coordination, or quality
improvement purposes:
(i) The patient's established primary care practitioner;
(ii) The patient's established primary care practice group or
entity; or
(iii) Other practitioner, or other practice group or entity,
identified by the patient as the practitioner, or practice group or
entity, primarily responsible for their care.
Sec. 485.542 Condition of participation: Emergency preparedness.
The REH must comply with all applicable Federal, state, and local
emergency preparedness requirements. The REH must establish and
maintain an emergency preparedness program that meets the requirements
of this section. The emergency preparedness program must include, but
not be limited to, the following elements:
(a) Emergency plan. The REH must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do the following:
(1) Be based on and include a documented, facility-based and
community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified
by the risk assessment.
(3) Address patient population, including, but not limited to, the
type of services the REH has the ability to provide in an emergency;
and continuity of operations, including delegations of authority and
succession plans.
(4) Include a process for cooperation and collaboration with local,
tribal, regional, state, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The REH must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
(1) The provision of subsistence needs for staff and patients,
whether they evacuate or shelter in place, include, but are not limited
to--
(i) Food, water, medical, and pharmaceutical supplies; and
(ii) Alternate sources of energy to maintain:
(A) Temperatures to protect patient health and safety and for the
safe and sanitary storage of provisions;
(B) Emergency lighting;
(C) Fire detection, extinguishing, and alarm systems; and
(D) Sewage and waste disposal.
(2) A system to track the location of on-duty staff and sheltered
patients in the REH's care during an emergency. If on-duty staff or
sheltered patients are relocated during the emergency, the REH must
document the specific name and location of the receiving facility or
other location.
(3) Safe evacuation from the REH, which includes the following:
(i) Consideration of care and treatment needs of evacuees.
(ii) Staff responsibilities.
(iii) Transportation.
(iv) Identification of evacuation location(s).
(v) Primary and alternate means of communication with external
sources of assistance.
(4) A means to shelter in place for patients, staff, and volunteers
who remain in the REH.
(5) A system of medical documentation that does the following:
(i) Preserves patient information.
(ii) Protects confidentiality of patient information.
(iii) Secures and maintains the availability of records.
(6) The use of volunteers in an emergency and other staffing
strategies, including the process and role for integration of state and
federally designated health care professionals to address surge needs
during an emergency.
(7) The role of the REH under a waiver declared by the Secretary,
in accordance with section 1135 of the Act, in the provision of care
and treatment at an alternate care site identified by emergency
management officials.
(c) Communication plan. The REH must develop and maintain an
emergency preparedness communication plan that complies with Federal,
state, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, state, tribal, regional, and local emergency
preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the
following:
(i) REH's staff.
(ii) Federal, state, tribal, regional, and local emergency
management agencies.
(4) A method for sharing information and medical documentation for
patients under the REH's care, as necessary, with other health care
providers to maintain the continuity of care.
(5) A means, in the event of an evacuation, to release patient
information as permitted under 45 CFR 164.510(b)(1)(ii).
(6) A means of providing information about the general condition
and location of patients under the facility's care as permitted under
45 CFR 164.510(b)(4).
(7) A means of providing information about the REH's needs, and its
ability to provide assistance, to the authority having jurisdiction,
the Incident Command Center, or designee.
(d) Training and testing. The REH must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
[[Page 40400]]
(1) Training program. The REH must do all of the following:
(i) Provide initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing on-site
services under arrangement, and volunteers, consistent with their
expected roles.
(ii) Provide emergency preparedness training at least every 2
years.
(iii) Maintain documentation of all emergency preparedness
training.
(iv) Demonstrate staff knowledge of emergency procedures.
(v) If the emergency preparedness policies and procedures are
significantly updated, the REH must conduct training on the updated
policies and procedures.
(2) Testing. The REH must conduct exercises to test the emergency
plan at least annually. The REH must do the following:
(i) Participate in a full-scale exercise that is community-based
every 2 years.
(A) When a community-based exercise is not accessible, conduct a
facility-based functional exercise every 2 years; or
(B) If the REH experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the REH is exempt from
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based, or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the REH's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
REH's emergency plan, as needed.
(e) Emergency and standby power systems. The CAH must implement
emergency and standby power systems based on the emergency plan set
forth in paragraph (a) of this section.
(1) Emergency generator location. The generator must be located in
accordance with the location requirements found in the Health Care
Facilities Code (National Fire Protection Association (NFPA) 99 and
Technical Interim Amendments (TIA) 12-2, TIA 12-3, TIA 12-4, TIA 12-5,
and TIA 12-6), Life Safety Code (NFPA 101 and TIA 12-1, TIA 12-2, TIA
12-3, and TIA 12-4), and NFPA 110, when a new structure is built or
when an existing structure or building is renovated.
(2) Emergency generator inspection and testing. The CAH must
implement emergency power system inspection and testing requirements
found in the Health Care Facilities Code, NFPA 110, and the Life Safety
Code.
(3) Emergency generator fuel. CAHs that maintain an onsite fuel
source to power emergency generators must have a plan for how it will
keep emergency power systems operational during the emergency, unless
it evacuates.
(f) Integrated healthcare systems. If an REH is part of a
healthcare system consisting of multiple separately certified
healthcare facilities that elects to have a unified and integrated
emergency preparedness program, the REH may choose to participate in
the healthcare system's coordinated emergency preparedness program. If
elected, the unified and integrated emergency preparedness program
must--
(1) Demonstrate that each separately certified facility within the
system actively participated in the development of the unified and
integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account
each separately certified facility's unique circumstances, patient
populations, and services offered.
(3) Demonstrate that each separately certified facility is capable
of actively using the unified and integrated emergency preparedness
program and is in compliance.
(4) Include a unified and integrated emergency plan that meets the
requirements of paragraphs (a)(2) through (4) of this section. The
unified and integrated emergency plan must also be based on and include
the following:
(i) A documented community-based risk assessment, utilizing an all-
hazards approach.
(ii) A documented individual facility-based risk assessment for
each separately certified facility within the health system, utilizing
an all-hazards approach.
(5) Include integrated policies and procedures that meet the
requirements set forth in paragraph (b) of this section, a coordinated
communication plan and training and testing programs that meet the
requirements of paragraphs (c) and (d) of this section, respectively.
(g) Incorporation by reference. The material listed in this
paragraph (g) is approved for incorporation by reference by the
Director of the Office of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the CMS must publish a document in the
Federal Register and the material must be available to the public. All
approved material is available for inspection at CMS and at the
National Archives and Records Administration (NARA). Contact CMS at:
CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD
21244. For information on the availability of this material at NARA,
email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from:
National Fire Protection Association (NFPA), 1 Batterymarch Park,
Quincy, MA 02169; phone: (617) 770-3000; www.nfpa.org.
(1) NFPA 99, Health Care Facilities Code, 2012 edition, issued
August 11, 2011.
(2) Technical interim amendment (TIA) 12-2 to NFPA 99, issued
August 11, 2011.
(3) TIA 12-3 to NFPA 99, issued August 9, 2012.
(4) TIA 12-4 to NFPA 99, issued March 7, 2013.
(5) TIA 12-5 to NFPA 99, issued August 1, 2013.
(6) TIA 12-6 to NFPA 99, issued March 3, 2014.
(7) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011.
(8) TIA 12-1 to NFPA 101, issued August 11, 2011.
(9) TIA 12-2 to NFPA 101, issued October 30, 2012.
(10) TIA 12-3 to NFPA 101, issued October 22, 2013.
(11) TIA 12-4 to NFPA 101, issued October 22, 2013.
(12) NFPA 110, Standard for Emergency and Standby Power Systems,
2010 edition, including TIAs to chapter 7, issued August 6, 2009.
Sec. 485.544 Condition of participation: Physical environment.
The REH must be constructed, arranged, and maintained to ensure the
safety of the patient, and to provide facilities for diagnosis and
treatment and for special services appropriate to the needs of the
community.
(a) Standard: Buildings. The condition of the physical plant and
the overall REH environment must be developed and maintained in such a
manner that the safety and well-being of patients are ensured.
[[Page 40401]]
(1) There must be emergency power and lighting in at least the
operating, recovery, and emergency rooms, and stairwells. In all other
areas not serviced by the emergency supply source, battery lamps and
flashlights must be available.
(2) There must be facilities for emergency gas and water supply.
(3) The REH must have a safe and sanitary environment, properly
constructed, equipped, and maintained to protect the health and safety
of patients.
(b) Standard: Facilities. The REH must maintain adequate facilities
for its services.
(1) Diagnostic and therapeutic facilities must be located for the
safety of patients.
(2) Facilities, supplies, and equipment must be maintained to
ensure an acceptable level of safety and quality.
(3) The extent and complexity of facilities must be determined by
the services offered.
(4) There must be proper ventilation, light, and temperature
controls in patient care, pharmaceutical, food preparation, and other
appropriate areas.
(c) Standard: Safety from fire. (1) Except as otherwise provided in
this section, the REH must meet the provisions applicable to Ambulatory
Health Care Occupancies, regardless of the number of patients served,
and must proceed in accordance with the Life Safety Code (NFPA 101 and
TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).
(2) In consideration of a recommendation by the state survey agency
or Accrediting Organization or at the discretion of the Secretary, may
waive, for periods deemed appropriate, specific provisions of the Life
Safety Code, which would result in unreasonable hardship upon an REH,
but only if the waiver will not adversely affect the health and safety
of the patients.
(3) The provisions of the Life Safety Code do not apply in a state
if CMS finds that a fire and safety code imposed by state law
adequately protects patients in an REH.
(4) An REH may place alcohol-based hand rub dispensers in its
facility if the dispensers are installed in a manner that adequately
protects against inappropriate access.
(5) When a sprinkler system is shut down for more than 10 hours,
the REH must:
(i) Evacuate the building or portion of the building affected by
the system outage until the system is back in service; or
(ii) Establish a fire watch until the system is back in service.
(d) Standard: Building safety. Except as otherwise provided in this
section, the REH must meet the applicable provisions and must proceed
in accordance with the 2012 edition of the Health Care Facilities Code
(NFPA 99 and TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5, and TIA 12-6).
(1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities
Code do not apply to an REH.
(2) If application of the Health Care Facilities Code required
under paragraph (d) of this section would result in unreasonable
hardship for the REH, CMS may waive specific provisions of the Health
Care Facilities Code, but only if the waiver does not adversely affect
the health and safety of patients.
(e) Incorporation by reference. The material listed in this
paragraph (e) is approved for incorporation by reference by the
Director of the Office of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, the CMS must publish a document in the
Federal Register and the material must be available to the public. All
approved material is available for inspection at CMS and at the
National Archives and Records Administration (NARA). Contact CMS at:
CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD
21244. For information on the availability of this material at NARA,
email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from:
National Fire Protection Association (NFPA), 1 Batterymarch Park,
Quincy, MA 02169; phone: (617) 770-3000; www.nfpa.org.
(1) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August
11, 2011.
(2) TIA 12-2 to NFPA 99, issued August 11, 2011.
(3) TIA 12-3 to NFPA 99, issued August 9, 2012.
(4) TIA 12-4 to NFPA 99, issued March 7, 2013.
(5) TIA 12-5 to NFPA 99, issued August 1, 2013.
(6) TIA 12-6 to NFPA 99, issued March 3, 2014.
(7) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(8) TIA 12-1 to NFPA 101, issued August 11, 2011.
(9) TIA 12-2 to NFPA 101, issued October 30, 2012.
(10) TIA 12-3 to NFPA 101, issued October 22, 2013.
(11) TIA 12-4 to NFPA 101, issued October 22, 2013.
Sec. 485.546 Condition of participation: Skilled nursing facility
distinct part unit.
If the REH provides skilled nursing facility services in a distinct
part unit, the services furnished by the distinct part unit must comply
with the requirements of participation for long-term care facilities
specified in part 483, subpart B, of this subchapter.
Subpart F--Conditions of Participation: Critical Access Hospitals
(CAHs)
0
3. Section 485.610 is amended by revising paragraph (c) to read as
follows:
Sec. 485.610 Condition of participation: Status and location.
* * * * *
(c) Standard: Location relative to other facilities or necessary
provider certification. (1) The CAH is located more than a 35-mile
drive on primary roads (or, in the case of mountainous terrain or in
areas with only secondary roads available, a 15-mile drive) from a
hospital or another CAH, or before January 1, 2006, the CAH is
certified by the State as being a necessary provider of health care
services to residents in the area. A CAH that is designated as a
necessary provider on or before December 31, 2005, will maintain its
necessary provider designation after January 1, 2006.
(2) Primary roads of travel for determining the driving distance of
a CAH and its proximity to other providers is defined as:
(i) A numbered Federal highway, including interstates, intrastates,
expressways, or any other numbered Federal highway; or
(ii) A numbered State highway with 2 or more lanes each way.
* * * * *
0
4. Section 485.614 is added to read as follows:
Sec. 485.614 Condition of participation: Patient's rights.
A CAH must protect and promote each patient's rights.
(a) Standard: Notice of rights. (1) A hospital must inform each
patient, or when appropriate, the patient's representative (as allowed
under State law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible.
(2) The hospital must establish a process for prompt resolution of
patient grievances and must inform each patient whom to contact to file
a grievance. The hospital's governing body must approve and be
responsible for the effective
[[Page 40402]]
operation of the grievance process and must review and resolve
grievances, unless it delegates the responsibility in writing to a
grievance committee. The grievance process must include a mechanism for
timely referral of patient concerns regarding quality of care or
premature discharge to the appropriate Utilization and Quality Control
Quality Improvement Organization. At a minimum:
(i) The hospital must establish a clearly explained procedure for
the submission of a patient's written or verbal grievance to the
hospital.
(ii) The grievance process must specify time frames for review of
the grievance and the provision of a response.
(iii) In its resolution of the grievance, the hospital must provide
the patient with written notice of its decision that contains the name
of the hospital contact person, the steps taken on behalf of the
patient to investigate the grievance, the results of the grievance
process, and the date of completion.
(b) Standard: Exercise of rights. (1) The patient has the right to
participate in the development and implementation of their plan of
care.
(2) The patient or their representative (as allowed under State
law) has the right to make informed decisions regarding their care. The
patient's rights include being informed of their health status, being
involved in care planning and treatment, and being able to request or
refuse treatment. This right must not be construed as a mechanism to
demand the provision of treatment or services deemed medically
unnecessary or inappropriate.
(3) The patient has the right to formulate advance directives and
to have hospital staff and practitioners who provide care in the
hospital comply with these directives, in accordance with Sec. Sec.
489.100, 489.102, and 489.104 of this chapter.
(4) The patient has the right to have a family member or
representative of their choice and their own physician notified
promptly of their admission to the hospital.
(c) Standard: Privacy and safety. (1) The patient has the right to
personal privacy.
(2) The patient has the right to receive care in a safe setting.
(3) The patient has the right to be free from all forms of abuse or
harassment.
(d) Standard: Confidentiality of patient records. (1) The patient
has the right to the confidentiality of their clinical records.
(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.
(e) Standard: Restraint or seclusion. All patients have the right
to be free from physical or mental abuse, and corporal punishment. All
patients have the right to be free from restraint or seclusion, of any
form, imposed as a means of coercion, discipline, convenience, or
retaliation by staff. Restraint or seclusion may only be imposed to
ensure the immediate physical safety of the patient, a staff member, or
others and must be discontinued at the earliest possible time.
(1)(i) A restraint is--
(A) Any manual method, physical or mechanical device, material, or
equipment that immobilizes or reduces the ability of a patient to move
their arms, legs, body, or head freely; or
(B) A drug or medication when it is used as a restriction to manage
the patient's behavior or restrict the patient's freedom of movement
and is not a standard treatment or dosage for the patient's condition.
(C) A restraint does not include devices, such as orthopedically
prescribed devices, surgical dressings or bandages, protective helmets,
or other methods that involve the physical holding of a patient for the
purpose of conducting routine physical examinations or tests, or to
protect the patient from falling out of bed, or to permit the patient
to participate in activities without the risk of physical harm (this
does not include a physical escort).
(ii) Seclusion is the involuntary confinement of a patient alone in
a room or area from which the patient is physically prevented from
leaving. Seclusion may only be used for the management of violent or
self-destructive behavior.
(2) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
patient a staff member or others from harm.
(3) The type or technique of restraint or seclusion used must be
the least restrictive intervention that will be effective to protect
the patient, a staff member, or others from harm.
(4) The CAH must have written policies and procedures regarding the
use of restraint and seclusion that are consistent with current
standards of practice.
(f) Standard: Restraint or seclusion: Staff training requirements.
The patient has the right to safe implementation of restraint or
seclusion by trained staff.
(1) The CAH must provide patient-centered, trauma informed
competency-based training and education of CAH personnel and staff,
including medical staff, and, as applicable, personnel providing
contracted services in the CAH, on the use of restraint and seclusion.
(2) The training must include alternatives to the use of restraint/
seclusion.
(g) Standard: Death reporting requirements. Hospitals must report
deaths associated with the use of seclusion or restraint.
(1) With the exception of deaths described under paragraph (g)(2)
of this section, the hospital must report the following information to
CMS by telephone, facsimile, or electronically, as determined by CMS,
no later than the close of business on the next business day following
knowledge of the patient's death:
(i) Each death that occurs while a patient is in restraint or
seclusion.
(ii) Each death that occurs within 24 hours after the patient has
been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week
after restraint or seclusion where it is reasonable to assume that use
of restraint or placement in seclusion contributed directly or
indirectly to a patient's death, regardless of the type(s) of restraint
used on the patient during this time. ``Reasonable to assume'' in this
context includes, but is not limited to, deaths related to restrictions
of movement for prolonged periods of time, or death related to chest
compression, restriction of breathing, or asphyxiation.
(2) When no seclusion has been used and when the only restraints
used on the patient are those applied exclusively to the patient's
wrist(s), and which are composed solely of soft, non-rigid, cloth-like
materials, the hospital staff must record in an internal log or other
system, the following information:
(i) Any death that occurs while a patient is in such restraints.
(ii) Any death that occurs within 24 hours after a patient has been
removed from such restraints.
[[Page 40403]]
(3) The staff must document in the patient's medical record the
date and time the death was:
(i) Reported to CMS for deaths described in paragraph (g)(1) of
this section; or
(ii) Recorded in the internal log or other system for deaths
described in paragraph (g)(2) of this section.
(4) For deaths described in paragraph (g)(2) of this section,
entries into the internal log or other system must be documented as
follows:
(i) Each entry must be made not later than seven days after the
date of death of the patient.
(ii) Each entry must document the patient's name, date of birth,
date of death, name of attending physician or other licensed
practitioner who is responsible for the care of the patient, medical
record number, and primary diagnosis(es).
(iii) The information must be made available in either written or
electronic form to CMS immediately upon request.
(h) Standard: Patient visitation rights. A CAH must have written
policies and procedures regarding the visitation rights of patients,
including those setting forth any clinically necessary or reasonable
restriction or limitation that the CAH may need to place on such rights
and the reasons for the clinical restriction or limitation. A CAH must
meet the following requirements:
(1) Inform each patient (or support person, where appropriate) of
his or her visitation rights, including any clinical restriction or
limitation on such rights, in advance of furnishing patient care
whenever possible.
(2) Inform each patient (or support person, where appropriate) of
the right, subject to his or her consent, to receive the visitors whom
he or she designates, including, but not limited to, a spouse, a
domestic partner (including a same-sex domestic partner), another
family member, or a friend, and his or her right to withdraw or deny
such consent at any time.
(3) Not restrict, limit, or otherwise deny visitation privileges on
the basis of race, color, national origin, religion, sex, gender
identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation
privileges consistent with patient preferences.
0
5. Section 485.631 is amended by adding paragraph (e) to read as
follows:
Sec. 485.631 Condition of participation: Staffing and staff
responsibilities.
* * * * *
(e) Standard: Unified and integrated medical staff for a CAH in a
multi-facility system. If a CAH is part of a system consisting of
multiple separately certified hospitals, CAHs, and/or REHs, and the
system elects to have a unified and integrated medical staff for its
member hospitals, CAHs, and/or REHs after determining that such a
decision is in accordance with all applicable State and local laws,
each separately certified CAH must demonstrate that:
(1) The medical staff members of each separately certified CAH in
the system (that is, all medical staff members who hold specific
privileges to practice at that CAH) have voted by majority, in
accordance with medical staff bylaws, either to accept a unified and
integrated medical staff structure or to opt out of such a structure
and to maintain a separate and distinct medical staff for their
respective CAH;
(2) The unified and integrated medical staff has bylaws, rules, and
requirements that describe its processes for self-governance,
appointment, credentialing, privileging, and oversight, as well as its
peer review policies and due process rights guarantees, and which
include a process for the members of the medical staff of each
separately certified CAH (that is, all medical staff members who hold
specific privileges to practice at that CAH) to be advised of their
rights to opt out of the unified and integrated medical staff structure
after a majority vote by the members to maintain a separate and
distinct medical staff for their CAH;
(3) The unified and integrated medical staff is established in a
manner that takes into account each member CAH's unique circumstances
and any significant differences in patient populations and services
offered in each hospital, CAH, and REH; and
(4) The unified and integrated medical staff establishes and
implements policies and procedures to ensure that the needs and
concerns expressed by members of the medical staff, at each of its
separately certified hospitals, CAHs, and REHs, regardless of practice
or location, are given due consideration, and that the unified and
integrated medical staff has mechanisms in place to ensure that issues
localized to particular hospitals, CAHs, and REHs are duly considered
and addressed.
Sec. 485.635 [Amended]
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6. Section 485.635 is amended--
0
a. In paragraph (b)(2) introductory text by removing the reference ``42
U.S.C. 236a'' and adding in its place the reference ``42 U.S.C. 263a'';
and
0
b. By removing paragraph (f).
0
7. Section 485.640 is amended by adding paragraph (g) to read as
follows:
Sec. 485.640 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
* * * * *
(g) Standard: Unified and integrated infection prevention and
control and antibiotic stewardship programs for a CAH in a multi-
facility system. If a CAH is part of a system consisting of multiple
separately certified hospitals, CAHs, and/or REHs using a system
governing body that is legally responsible for the conduct of two or
more hospitals, CAHs, and/or REHs, the system governing body can elect
to have unified and integrated infection prevention and control and
antibiotic stewardship programs for all of its member facilities after
determining that such a decision is in accordance with all applicable
State and local laws. The system governing body is responsible and
accountable for ensuring that each of its separately certified CAHs
meets all of the requirements of this section. Each separately
certified CAH subject to the system governing body must demonstrate
that:
(1) The unified and integrated infection prevention and control and
antibiotic stewardship programs are established in a manner that takes
into account each member CAH's unique circumstances and any significant
differences in patient populations and services offered in each CAH;
(2) The unified and integrated infection prevention and control and
antibiotic stewardship programs establish and implement policies and
procedures to ensure that the needs and concerns of each of its
separately certified CAHs, regardless of practice or location, are
given due consideration;
(3) The unified and integrated infection prevention and control and
antibiotic stewardship programs have mechanisms in place to ensure that
issues localized to particular CAHs are duly considered and addressed;
and
(4) A qualified individual (or individuals) with expertise in
infection prevention and control and in antibiotic stewardship has been
designated at the CAH as responsible for communicating with the unified
infection prevention and control and antibiotic stewardship programs,
for implementing and maintaining the policies and procedures governing
infection prevention and control and antibiotic stewardship as directed
by the unified infection prevention and control and antibiotic
stewardship programs, and for providing education and training on the
practical applications of infection prevention and control and
antibiotic stewardship to CAH staff.
[[Page 40404]]
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8. Section 485.641 is amended by adding paragraph (f) to read as
follows:
Sec. 485.641 Condition of participation: Quality assessment and
performance improvement program.
* * * * *
(f) Standard: Unified and integrated QAPI program for a CAH in a
multi-facility system. If a CAH is part of a system consisting of
multiple separately certified hospitals, CAHs, and/or REHs using a
system governing body that is legally responsible for the conduct of
two or more hospitals, CAHs, and/or REHs, the system governing body can
elect to have a unified and integrated QAPI program for all of its
member facilities after determining that such a decision is in
accordance with all applicable State and local laws. The system
governing body is responsible and accountable for ensuring that each of
its separately certified CAHs meets all of the requirements of this
section. Each separately certified CAH subject to the system governing
body must demonstrate that:
(1) The unified and integrated QAPI program is established in a
manner that takes into account each member CAH's unique circumstances
and any significant differences in patient populations and services
offered in each CAH; and
(2) The unified and integrated QAPI program establishes and
implements policies and procedures to ensure that the needs and
concerns of each of its separately certified CAHs, regardless of
practice or location, are given due consideration, and that the unified
and integrated QAPI program has mechanisms in place to ensure that
issues localized to particular CAHs are duly considered and addressed.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
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9. The authority citation for part 489 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc,
1395ff, and 1395hh.
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10. Section 489.2 is amended by adding paragraph (b)(11) to read as
follows:
Sec. 489.2 Scope of part.
* * * * *
(b) * * *
(11) Rural emergency hospitals (REHs).
* * * * *
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11. Section 489.24 is amended in paragraph (b) by revising the
definitions of ``Hospital'' and ``Participating hospital'' to read as
follows:
Sec. 489.24 Special responsibilities of Medicare hospitals in
emergency cases.
* * * * *
(b) * * *
Hospital includes a critical access hospital as defined in section
1861(mm)(1) of the Act and a rural emergency hospital as defined in
section 1861(kkk)(2).
* * * * *
Participating hospital means:
(1) A hospital;
(2) A critical access hospital as defined in section 1861(mm)(1) of
the Act that has entered into a Medicare provider agreement under
section 1866 of the Act; or
(3) A rural emergency hospital as defined in section 1861(kkk)(2)
of the Act.
* * * * *
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-14153 Filed 6-30-22; 4:15 pm]
BILLING CODE 4120-01-P