[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52458-52459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3370-PN]


Medicare and Medicaid Program; Application from the Accreditation 
Association for Hospitals/Health Systems-Healthcare Facilities 
Accreditation Program (AAHHS-HFAP) for Approval of its Hospital 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with request for comment.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Accreditation Association for Hospitals/Health 
Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for 
recognition as a national accrediting organization for 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 November 16, 
2018.

ADDRESSES: In commenting, refer to file code CMS-3370-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-3370-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-3370-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: Monda Shaver, (410) 786-3410, Mary 
Ellen Palowitch, (410) 786-4496, or Renee Henry, (410) 786-7828.

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: 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 from a hospital, provided that certain requirements 
are met. Section 1861(e) of the Social Security Act (the Act), 
establishes distinct criteria for facilities seeking designation as a 
hospital. 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 482 specify the minimum conditions that a hospital must 
meet to participate in the Medicare program.
    Generally, to enter into an agreement, a hospital must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 482 of our regulations. Thereafter, the 
hospital 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 may 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 may 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 accrediting organizations to reapply 
for continued approval of its accreditation program every 6 years or 
sooner as determined by CMS.

II. Provisions of the Proposed Notice

A. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our

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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 us 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 approval of its hospital accreditation 
program. This notice also solicits public comment on whether AAHHS-
HFAP's requirements meet or exceed the Medicare conditions of 
participation (CoPs) for hospitals.

B. 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 hospital accreditation program. This application was determined to 
be complete on August 17, 2018. Under section 1865(a)(2) of the Act and 
our regulations at Sec.  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 hospitals as 
compared with CMS' hospital CoPs.
     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 hospital 
found out of compliance with the AAHHS-HFAP's program requirements. 
These monitoring procedures are used only when the AAHHS-HFAP 
identifies noncompliance. If noncompliance is identified through 
validation reviews or complaint surveys, the state survey agency 
monitors corrections as specified at Sec.  488.9(c).
    ++ 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 we may require (including corrective action 
plans).

C. Notice Upon Completion of Evaluation

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

III. 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).

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.

    Dated: October 10, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-22546 Filed 10-16-18; 8:45 am]
 BILLING CODE 4120-01-P