[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37302-37303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3377-PN]


Medicare and Medicaid Programs: Application From Accreditation 
Association of Hospitals/Health Systems--Healthcare Facilities 
Accreditation Program (AAHHS-HFAP) for Continued CMS-Approval of Its 
Critical Access Hospital (CAH) Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from Accreditation Association of Hospitals/Health 
Systems--Healthcare Facilities Accreditation Program for continued 
recognition as a national accrediting organization for critical access 
hospitals that wish to participate in the Medicare or Medicaid 
programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 30, 2019.

ADDRESSES: In commenting, refer to file code CMS-3377-PN. 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 http://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-3377-PN, 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-3377-PN, 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: 
    Mary Ellen Palowitch, (410) 786-4496.
    Anita Moore, (410) 786-2161.

SUPPLEMENTARY INFORMATION: 
    Submitting Comments: We welcome comments from the public on all 
issues set forth in this proposed notice to assist us in fully 
considering issues and developing policies. Referencing the file code 
CMS-3377-PN and the specific ``issue identifier'' that precedes the 
section on which you choose to comment will assist us in fully 
considering issues and developing policies.
    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: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (CAH) provided certain 
requirements are met by the CAH. Section 1861(mm) of the Social 
Security Act (the Act), sets out definitions for ``critical access 
hospital'' and for inpatient and outpatient CAH services. Regulations 
concerning provider agreements are at 42 CFR part 489 and those 
pertaining to activities relating to the survey and certification of 
facilities are at 42 CFR part 488. The regulations at 42 CFR part 485, 
subpart F specify the conditions that a CAH must meet to participate in 
the Medicare program, the scope of covered services, and the conditions 
for Medicare payment for CAHs.
    Generally, to enter into an agreement, a CAH must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 485 of our regulations. Thereafter, the 
CAH is subject to regular surveys by a State survey agency to determine 
whether it continues to meet these requirements. There is an 
alternative; however, to surveys by State agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services (the Secretary) as having 
standards for accreditation that meet or exceed Medicare requirements, 
any provider entity accredited by the national accrediting body's 
approved program would be deemed to meet the Medicare conditions. A 
national accrediting organization applying for approval of its 
accreditation program under part 488, subpart A, must provide the 
Centers for Medicare and Medicaid Services (CMS) with reasonable 
assurance that the accrediting organization requires the accredited 
provider entities to meet requirements that are at least as stringent 
as the Medicare conditions. Our regulations concerning the approval of 
accrediting organizations are set forth at Sec.  488.5. The regulations 
at Sec.  488.5(e)(2)(i) require an accrediting organization to reapply 
for continued approval of its accreditation program every 6 years or as 
determined by CMS. Accreditation Association of Hospitals/Health 
Systems--Healthcare Facilities Accreditation Programs (AAHHS-HFAP) 
current term of approval for its CAH accreditation program expires 
December 27, 2019.

[[Page 37303]]

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at 42 CFR 488.5 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization's requirements for accreditation; 
survey procedures; resources for conducting required surveys; capacity 
to furnish information for use in enforcement activities; monitoring 
procedures for provider entities found not in compliance with the 
conditions or requirements; and ability to provide CMS with the 
necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of 
AAHHS-HFAP's request for continued CMS approval of its CAH 
accreditation program. This notice also solicits public comment on 
whether AAHHS-HFAP's requirements meet or exceed the Medicare 
conditions of participation for CAHs.

III. Evaluation of Deeming Authority Request

    AAHHS-HFAP submitted all the necessary materials to enable us to 
make a determination concerning its request for continued approval of 
its CAH accreditation program. This application was determined to be 
complete on May 31, 2019. Under Section 1865(a)(2) of the Act and our 
regulations at 42 CFR 488.5 (Application and re-application procedures 
for national accrediting organizations), our review and evaluation of 
AAHHS-HFAP will be conducted in accordance with, but not necessarily 
limited to, the following factors:
     The equivalency of AAHHS-HFAP's standards for CAHs as 
compared with CMS' CAH conditions of participation.
     AAHHS-HFAP's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of AAHHS-HFAP's processes to those of State 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAHHS-HFAP's processes and procedures for monitoring a CAH found 
out of compliance with AAHHS-HFAP's program requirements. These 
monitoring procedures are used only when AAHHS-HFAP identifies 
noncompliance. If noncompliance is identified through validation 
reviews or complaint surveys conducted by the State survey agency, the 
State survey agency monitors corrections as specified at 42 CFR 488.9.
    ++ AAHHS-HFAP's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAHHS-HFAP's capacity to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of AAHHS-HFAP's staff and other resources, and its 
financial viability.
    ++ AAHHS-HFAP's capacity to adequately fund required surveys.
    ++ AAHHS-HFAP's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ AAHHS-HFAP's agreement to provide CMS with a copy of the most 
current accreditation survey together with any other information 
related to the survey as CMS may require (including corrective action 
plans).

IV. Collection of Information Requirements

    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 Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. Chapter 35).

V. Response to Public 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.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal Register announcing the result of our evaluation.

    Dated: July 24, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-16371 Filed 7-30-19; 8:45 am]
 BILLING CODE 4120-01-P