[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22894-22895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3424-PN]


Medicare and Medicaid Programs: Application From Det Norske 
Veritas for Continued Approval of Its Hospital Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: This notice acknowledges the receipt of an application from 
Det Norske Veritas for continued 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 May 18, 2022.

ADDRESSES: In commenting, please refer to file code CMS-3424-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-3424-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-3424-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:  Joy Webb, (410) 786-1667. Lillian 
William, (410) 786-8636.

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. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospital provided 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 (SA) 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 SA to 
determine whether it continues to meet these requirements.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by a Centers for Medicare & Medicaid 
Services (CMS) approved national accrediting organization (AO) that all 
applicable Medicare conditions are met or exceeded, we will deem those 
provider entities as having met the requirements. Accreditation by an 
AO is voluntary and is not required for Medicare participation.
    If an AO 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 AO applying 
for approval of its accreditation program under part 488, subpart A, 
must provide CMS with reasonable assurance that the AO requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions. Our regulations concerning the 
approval of AOs are set forth at Sec. Sec.  488.4 and 488.5. The 
regulations at Sec.  488.5(e)(2)(i) require AOs to reapply for 
continued approval of its accreditation program every 6 years or sooner 
as determined by CMS.
    Det Norske Veritas' current term of approval for their hospital 
accreditation program expires September 26, 2022.

II. Approval of Deeming Organization

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO'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 Det 
Norske Veritas' request for continued approval of its hospital 
accreditation program. This notice also solicits public comment on 
whether Det Norske Veritas' requirements meet or exceed the Medicare 
conditions of participation (CoPs) for hospitals.

III. Evaluation of Deeming Authority Request

    Det Norske Veritas submitted all the necessary materials to enable 
us to make a determination concerning its request

[[Page 22895]]

for continued approval of its hospital accreditation program. This 
application was determined to be complete on February 28, 2022. 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 Det Norske Veritas will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of Det Norske Veritas' standards for 
hospitals as compared with CMS' hospital CoPs.
     Det Norske Veritas' 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 Det Norske Veritas' processes to those of 
state agencies, including survey frequency, and the ability to 
investigate and respond appropriately to complaints against accredited 
facilities.
    ++ Det Norske Veritas' processes and procedures for monitoring a 
hospital found out of compliance with Det Norske Veritas' program 
requirements. These monitoring procedures are used only when Det Norske 
Veritas identifies noncompliance. If noncompliance is identified 
through validation reviews or complaint surveys, the SA monitors 
corrections as specified at Sec.  488.9.
    ++ Det Norske Veritas' capacity to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    ++ Det Norske Veritas' capacity to provide CMS with electronic data 
and reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of Det Norske Veritas' staff and other resources, 
and its financial viability.
    ++ Det Norske Veritas' capacity to adequately fund required 
surveys.
    ++ Det Norske Veritas' policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ Det Norske Veritas' policies and procedures to avoid conflicts 
of interest, including the appearance of conflicts of interest, 
involving individuals who conduct surveys or participate in 
accreditation decisions.
    ++ Det Norske Veritas' 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).

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.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: April 13, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-08251 Filed 4-15-22; 8:45 am]
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