Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care; Extension of Timeline for Publication of the Final Rule, 27069-27070 [2019-12216]
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Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Proposed Rules
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apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
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applicable to manufacturers, importers,
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2019–12115 Filed 6–10–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 482 and 485
[CMS–3295–RCN]
RIN 0938–AS21
Medicare and Medicaid Programs;
Hospital and Critical Access Hospital
(CAH) Changes To Promote
Innovation, Flexibility, and
Improvement in Patient Care;
Extension of Timeline for Publication
of the Final Rule
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Extension of timeline for
publication of a final rule.
AGENCY:
This document announces the
extension of the timeline for publication
of the ‘‘Medicare and Medicaid
Programs; Hospital and Critical Access
Hospital (CAH) Changes to Promote
Innovation, Flexibility, and
Improvement in Patient Care’’ final rule.
We are issuing this document in
accordance with section 1871(a)(3)(B) of
the Social Security Act (the Act), which
requires notice to be provided in the
Federal Register if there are exceptional
circumstances that cause us to publish
a final rule more than 3 years after the
publication date of the proposed rule. In
this case, the complexity of the rule, its
substantive nature, and the scope of
comments received all warrant the
extension of the timeline for
publication.
khammond on DSKBBV9HB2PROD with PROPOSALS
SUMMARY:
As of June 7, 2019, the timeline
for publication of the final rule to
DATES:
VerDate Sep<11>2014
16:27 Jun 10, 2019
Jkt 247001
finalize the provisions of the June 16,
2016 proposed rule (81 FR 39447) is
extended until June 16, 2020.
FOR FURTHER INFORMATION CONTACT:
CAPT Scott Cooper, USPHS, (410) 786–
9465.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1871(a)(3)(A) of the Social
Security Act (the Act) requires the
Secretary of the Department of Health
and Human Services (the Secretary), in
consultation with the Director of the
Office of Management and Budget
(OMB), to establish a regular timeline
for the publication of a final rule based
on the previous publication of a
proposed rule or an interim final rule.
Section 1871(a)(3)(B) of the Act
allows the timeline for publishing
Medicare final regulations to vary based
on the complexity of the regulation, the
number and scope of comments
received, and other related factors. The
timeline for publishing the final rule,
however, cannot exceed 3 years from
the date of publishing the proposed
regulation unless there are exceptional
circumstances. The Secretary may
extend the initial targeted publication
date of the final rule if the Secretary
provides public notice thereof,
including a brief explanation of the
justification for the variation, no later
than the rule’s previously established
proposed publication date.
After consultation with the Director of
OMB, the Department of Health and
Human Services (HHS), through the
Centers for Medicare & Medicaid
Services (CMS), published a notice in
the December 30, 2004 Federal Register
(69 FR 78442) establishing a general 3year timeline for publishing Medicare
final rules after the publication of a
proposed or interim final rule.
II. Notice of Continuation
Sections 1861(e)(1) through (8) of the
Act provide that a hospital participating
in the Medicare program must meet
certain specified requirements. Section
1861(e)(9) of the Act specifies that a
hospital also must meet such other
requirements as the Secretary finds
necessary in the interest of the health
and safety of individuals furnished
services in the institution. Under this
authority, the Secretary has established
regulatory requirements that a hospital
must meet to participate in Medicare at
42 CFR part 482, Conditions of
Participation (CoPs) for Hospitals.
Section 1905(a) of the Act provides that
Medicaid payments from States may be
applied to hospital services. Under
regulations at 42 CFR 440.10(a)(3)(iii)
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
27069
and § 440.20(a)(3)(ii), hospitals are
required to meet the Medicare CoPs in
order to participate in Medicaid.
On May 26, 1993, CMS published a
final rule in the Federal Register
entitled ‘‘Medicare Program; Essential
Access Community Hospitals (EACHs)
and Rural Primary Care Hospitals
(RPCHs)’’ (58 FR 30630) that
implemented sections 6003(g) and 6116
of the Omnibus Budget Reconciliation
Act (OBRA) of 1989 and section 4008(d)
of OBRA 1990. That rule established
requirements for the EACH and RPCH
providers that participated in the sevenstate demonstration program that was
designed to improve access to hospital
and other health services for rural
residents.
Sections 1820 and 1861(mm) of the
Act, as amended by section 4201 of the
Balanced Budget Act (BBA) of 1997,
replaced the EACH/RPCH program with
the Medicare Rural Hospital Flexibility
Program (MRHFP), under which a
qualifying facility can be designated and
certified as a Critical Access Hospital
(CAH). CAHs participating in the
MRHFP must meet the conditions for
designation specified in the statute
under section 1820(c)(2)(B) of the Act,
and to be certified must also meet other
criteria the Secretary may require, under
section 1820(e)(3) of the Act. Under this
authority, the Secretary has established
regulatory requirements that a CAH
must meet to participate in Medicare at
42 CFR part 485, subpart F.
In the June 16, 2016 Federal Register
(81 FR 39447), we published a proposed
rule entitled, ‘‘Medicare and Medicaid
Programs; Hospital and Critical Access
Hospital (CAH) Changes to Promote
Innovation, Flexibility, and
Improvement in Patient Care,’’ which
would update the requirements that
hospitals and CAHs must meet to
participate in the Medicare and
Medicaid programs. Consistent with
section 1871(a)(3)(B) of the Act, the final
rule for the June 16, 2016 proposed rule
was to be published by June 14, 2019.
The revisions contained in the June
16, 2016 proposed rule were intended to
conform the requirements to current
standards of practice and support
improvements in quality of care, reduce
barriers to care, and reduce some issues
that may exacerbate workforce shortage
concerns. In response to the proposed
rule, we received 200 public comments.
Commenters included individuals,
healthcare professionals and
corporations, national associations and
coalitions, state health departments,
patient advocacy organizations, and
individual facilities that would be
impacted by the regulation. Generally,
most comments centered on expressing
E:\FR\FM\11JNP1.SGM
11JNP1
khammond on DSKBBV9HB2PROD with PROPOSALS
27070
Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Proposed Rules
support for the regulatory changes,
especially those concerning use of the
term ‘‘licensed independent
practitioner,’’ aspects of those aimed at
infection control and antibiotic
stewardship, and those focused on
reducing burden and costs for CAHs in
the provision of dietary and nutritional
services while increasing the
effectiveness and benefits of those vital
services for patients. However, some
commenters expressed concern that we
underestimated the time and effort
required for compliance with the
antibiotic stewardship and Quality
Assessment and Performance
Improvement (QAPI) requirements,
especially for smaller hospitals,
including CAHs. Commenters requested
a delayed implementation for these
particular requirements.
This document announces an
extension of the timeline for publication
of the final rule due to exceptional
circumstances. We were not able to
meet the 3-year timeline for the
publication of the final rule due to the
complexity and substantive nature of
the provisions proposed in the June 16,
2016 proposed rule. Additional time is
needed to fully consider all the
comments and provisions, and to ensure
that we most appropriately modernize
and revise the requirements of the CoPs
for hospitals and CAHs. Some of these
proposed changes include provisions to
address—(1) use of the term ‘‘Licensed
Independent Practitioners;’’ (2)
requirements that do not fully conform
to current standards for infection
control; (3) requirements for antibiotic
stewardship programs to help reduce
inappropriate antibiotic use and
antimicrobial resistance; (4) the use of
quality reporting program data by
hospital QAPI programs; (5) a new
requirement for CAHs that mirrors the
existing QAPI requirements for
hospitals; and (6) a new provision that
would allow CAHs to grant qualified
dietitians and nutrition professionals
ordering privileges for dietary services,
mirroring an existing provision in the
hospital CoPs.
As stated in the Fall 2018 Unified
Agenda of Regulatory and Deregulatory
Actions (https://www.reginfo.gov/
public/do/eAgendaViewRule?pubId=
201810&RIN=0938-AS21), we may
finalize the June 16, 2016 proposed rule
by merging some of the provisions into
other related rulemaking documents.
Currently, we are reviewing comments
to determine whether to finalize at least
one of the provisions from the June 16,
2016 proposed rule regarding patient
rights in hospitals. We plan to address
the remaining provisions of the June 16,
VerDate Sep<11>2014
16:27 Jun 10, 2019
Jkt 247001
2016 proposed rule in future
rulemaking.
We stress that our decision in this
matter to extend the timeline for issuing
a final rule should not be viewed as a
diminution of the Department’s
commitment to timely and effective
rulemaking. Our goal remains to
publish, as expeditiously as feasible, a
final rule that supports improvements in
the quality of patient care through
adoption of current standards of
practice, while also minimizing the
burden on providers to the maximum
possible extent. At this time, we believe
we can best achieve this balance by
issuing this continuation document.
Therefore, this document extends the
timeline to finalize the provisions in the
June 16, 2016 proposed rule for 1 year,
until June 16, 2020.
III. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the OMB under the authority
of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Dated: May 6, 2019.
Ann C. Agnew,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2019–12216 Filed 6–7–19; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Ch. IV
[CMS–6082–NC]
RIN 0938–ZB54
Request for Information; Reducing
Administrative Burden To Put Patients
Over Paperwork
Centers for Medicare &
Medicaid Services (CMS), HHS;
Department of the Treasury.
ACTION: Request for information.
AGENCY:
CMS is committed to
transforming the health care delivery
system—and the Medicare and
Medicaid programs—by putting
additional focus on patient-centered
care, innovation, and outcomes. As part
of our continuing Patients over
Paperwork initiative, we have actively
solicited feedback from the medical
community through Requests for
SUMMARY:
PO 00000
Frm 00029
Fmt 4702
Sfmt 4702
Information (RFIs), listening sessions,
and clinical onsite engagements with
front-line clinicians and staff to learn
how our administrative requirements
and processes affect their daily work
and ability to innovate in care delivery.
This RFI solicits additional public
comment on ideas for regulatory,
subregulatory, policy, practice, and
procedural changes that reduce
unnecessary administrative burdens for
clinicians, providers, patients and their
families. Through these efforts, we aim
to increase quality of care, lower costs,
improve program integrity, and make
the health care system more effective,
simple, and accessible.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on August 12, 2019.
ADDRESSES: In commenting, refer to file
code CMS–6082–NC. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
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–6082–NC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–6082–NC,
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:
Morgan Taylor, Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, at (410)
786–3458.
Mary G. Greene, Centers for Medicare
& Medicaid Services, Department of
Health and Human Services, at (410)
786–1244.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
E:\FR\FM\11JNP1.SGM
11JNP1
]]>Agencies
[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Proposed Rules]
[Pages 27069-27070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12216]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 482 and 485
[CMS-3295-RCN]
RIN 0938-AS21
Medicare and Medicaid Programs; Hospital and Critical Access
Hospital (CAH) Changes To Promote Innovation, Flexibility, and
Improvement in Patient Care; Extension of Timeline for Publication of
the Final Rule
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Extension of timeline for publication of a final rule.
-----------------------------------------------------------------------
SUMMARY: This document announces the extension of the timeline for
publication of the ``Medicare and Medicaid Programs; Hospital and
Critical Access Hospital (CAH) Changes to Promote Innovation,
Flexibility, and Improvement in Patient Care'' final rule. We are
issuing this document in accordance with section 1871(a)(3)(B) of the
Social Security Act (the Act), which requires notice to be provided in
the Federal Register if there are exceptional circumstances that cause
us to publish a final rule more than 3 years after the publication date
of the proposed rule. In this case, the complexity of the rule, its
substantive nature, and the scope of comments received all warrant the
extension of the timeline for publication.
DATES: As of June 7, 2019, the timeline for publication of the final
rule to finalize the provisions of the June 16, 2016 proposed rule (81
FR 39447) is extended until June 16, 2020.
FOR FURTHER INFORMATION CONTACT: CAPT Scott Cooper, USPHS, (410) 786-
9465.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1871(a)(3)(A) of the Social Security Act (the Act) requires
the Secretary of the Department of Health and Human Services (the
Secretary), in consultation with the Director of the Office of
Management and Budget (OMB), to establish a regular timeline for the
publication of a final rule based on the previous publication of a
proposed rule or an interim final rule.
Section 1871(a)(3)(B) of the Act allows the timeline for publishing
Medicare final regulations to vary based on the complexity of the
regulation, the number and scope of comments received, and other
related factors. The timeline for publishing the final rule, however,
cannot exceed 3 years from the date of publishing the proposed
regulation unless there are exceptional circumstances. The Secretary
may extend the initial targeted publication date of the final rule if
the Secretary provides public notice thereof, including a brief
explanation of the justification for the variation, no later than the
rule's previously established proposed publication date.
After consultation with the Director of OMB, the Department of
Health and Human Services (HHS), through the Centers for Medicare &
Medicaid Services (CMS), published a notice in the December 30, 2004
Federal Register (69 FR 78442) establishing a general 3-year timeline
for publishing Medicare final rules after the publication of a proposed
or interim final rule.
II. Notice of Continuation
Sections 1861(e)(1) through (8) of the Act provide that a hospital
participating in the Medicare program must meet certain specified
requirements. Section 1861(e)(9) of the Act specifies that a hospital
also must meet such other requirements as the Secretary finds necessary
in the interest of the health and safety of individuals furnished
services in the institution. Under this authority, the Secretary has
established regulatory requirements that a hospital must meet to
participate in Medicare at 42 CFR part 482, Conditions of Participation
(CoPs) for Hospitals. Section 1905(a) of the Act provides that Medicaid
payments from States may be applied to hospital services. Under
regulations at 42 CFR 440.10(a)(3)(iii) and Sec. 440.20(a)(3)(ii),
hospitals are required to meet the Medicare CoPs in order to
participate in Medicaid.
On May 26, 1993, CMS published a final rule in the Federal Register
entitled ``Medicare Program; Essential Access Community Hospitals
(EACHs) and Rural Primary Care Hospitals (RPCHs)'' (58 FR 30630) that
implemented sections 6003(g) and 6116 of the Omnibus Budget
Reconciliation Act (OBRA) of 1989 and section 4008(d) of OBRA 1990.
That rule established requirements for the EACH and RPCH providers that
participated in the seven-state demonstration program that was designed
to improve access to hospital and other health services for rural
residents.
Sections 1820 and 1861(mm) of the Act, as amended by section 4201
of the Balanced Budget Act (BBA) of 1997, replaced the EACH/RPCH
program with the Medicare Rural Hospital Flexibility Program (MRHFP),
under which a qualifying facility can be designated and certified as a
Critical Access Hospital (CAH). CAHs participating in the MRHFP must
meet the conditions for designation specified in the statute under
section 1820(c)(2)(B) of the Act, and to be certified must also meet
other criteria the Secretary may require, under section 1820(e)(3) of
the Act. Under this authority, the Secretary has established regulatory
requirements that a CAH must meet to participate in Medicare at 42 CFR
part 485, subpart F.
In the June 16, 2016 Federal Register (81 FR 39447), we published a
proposed rule entitled, ``Medicare and Medicaid Programs; Hospital and
Critical Access Hospital (CAH) Changes to Promote Innovation,
Flexibility, and Improvement in Patient Care,'' which would update the
requirements that hospitals and CAHs must meet to participate in the
Medicare and Medicaid programs. Consistent with section 1871(a)(3)(B)
of the Act, the final rule for the June 16, 2016 proposed rule was to
be published by June 14, 2019.
The revisions contained in the June 16, 2016 proposed rule were
intended to conform the requirements to current standards of practice
and support improvements in quality of care, reduce barriers to care,
and reduce some issues that may exacerbate workforce shortage concerns.
In response to the proposed rule, we received 200 public comments.
Commenters included individuals, healthcare professionals and
corporations, national associations and coalitions, state health
departments, patient advocacy organizations, and individual facilities
that would be impacted by the regulation. Generally, most comments
centered on expressing
[[Page 27070]]
support for the regulatory changes, especially those concerning use of
the term ``licensed independent practitioner,'' aspects of those aimed
at infection control and antibiotic stewardship, and those focused on
reducing burden and costs for CAHs in the provision of dietary and
nutritional services while increasing the effectiveness and benefits of
those vital services for patients. However, some commenters expressed
concern that we underestimated the time and effort required for
compliance with the antibiotic stewardship and Quality Assessment and
Performance Improvement (QAPI) requirements, especially for smaller
hospitals, including CAHs. Commenters requested a delayed
implementation for these particular requirements.
This document announces an extension of the timeline for
publication of the final rule due to exceptional circumstances. We were
not able to meet the 3-year timeline for the publication of the final
rule due to the complexity and substantive nature of the provisions
proposed in the June 16, 2016 proposed rule. Additional time is needed
to fully consider all the comments and provisions, and to ensure that
we most appropriately modernize and revise the requirements of the CoPs
for hospitals and CAHs. Some of these proposed changes include
provisions to address--(1) use of the term ``Licensed Independent
Practitioners;'' (2) requirements that do not fully conform to current
standards for infection control; (3) requirements for antibiotic
stewardship programs to help reduce inappropriate antibiotic use and
antimicrobial resistance; (4) the use of quality reporting program data
by hospital QAPI programs; (5) a new requirement for CAHs that mirrors
the existing QAPI requirements for hospitals; and (6) a new provision
that would allow CAHs to grant qualified dietitians and nutrition
professionals ordering privileges for dietary services, mirroring an
existing provision in the hospital CoPs.
As stated in the Fall 2018 Unified Agenda of Regulatory and
Deregulatory Actions (https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0938-AS21), we may finalize the June
16, 2016 proposed rule by merging some of the provisions into other
related rulemaking documents. Currently, we are reviewing comments to
determine whether to finalize at least one of the provisions from the
June 16, 2016 proposed rule regarding patient rights in hospitals. We
plan to address the remaining provisions of the June 16, 2016 proposed
rule in future rulemaking.
We stress that our decision in this matter to extend the timeline
for issuing a final rule should not be viewed as a diminution of the
Department's commitment to timely and effective rulemaking. Our goal
remains to publish, as expeditiously as feasible, a final rule that
supports improvements in the quality of patient care through adoption
of current standards of practice, while also minimizing the burden on
providers to the maximum possible extent. At this time, we believe we
can best achieve this balance by issuing this continuation document.
Therefore, this document extends the timeline to finalize the
provisions in the June 16, 2016 proposed rule for 1 year, until June
16, 2020.
III. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the OMB
under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).
Dated: May 6, 2019.
Ann C. Agnew,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2019-12216 Filed 6-7-19; 11:15 am]
BILLING CODE 4120-01-P
