[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]
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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.
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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]
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