[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]
BILLING CODE 4120-01-P