83 FR 16862 - Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 74 (April 17, 2018)

Page Range		16862-16863
FR Document		2018-07982

This proposed notice acknowledges the receipt of an application from DNV GL--Healthcare for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

Federal Register, Volume 83 Issue 74 (Tuesday, April 17, 2018)

[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16862-16863]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-07982]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3357-PN]

Medicare and Medicaid Program; Application From DNV GL--
Healthcare (DNV GL) for Continued Approval of Its Hospital
Accreditation Program

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

ACTION: Notice with request for comment.

-----------------------------------------------------------------------

SUMMARY: This proposed notice acknowledges the receipt of an
application from DNV GL--Healthcare for continued recognition as a
national accrediting organization for hospitals that wish to
participate in the Medicare or Medicaid programs. The statute requires
that we publish, within 60 days of receipt of an organization's
complete application, a notice that identifies the national accrediting
body making the request, describes the nature of the request, and
provides at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 17, 2018.

ADDRESSES: In commenting, refer to file code CMS-3357-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-3357-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-3357-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: Karena Meushaw (410) 786-6609,
Patricia Chmielewski, (410) 786-6899 or Monda Shaver, (410) 786-3410.

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

[[Page 16863]]

sooner as determined by CMS. DNV GL--Healthcare (DNV GL) current term
of approval for their hospital accreditation program expires September
26, 2018.

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 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 DNV
GL's request for continued approval of its hospital accreditation
program. This notice also solicits public comment on whether DNV GL's
requirements meet or exceed the Medicare conditions of participation
(CoPs) for hospitals.

B. Evaluation of Deeming Authority Request

DNV GL 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 February 28, 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 DNV GL will be conducted in accordance with, but not
necessarily limited to, the following factors:
The equivalency of DNV GL's standards for hospitals as
compared with CMS' hospital CoPs.
DNV GL'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 DNV GL's processes to those of state
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ DNV GL's processes and procedures for monitoring a hospital
found out of compliance with the DNV GL's program requirements. These
monitoring procedures are used only when the DNV GL 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).
++ DNV GL's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ DNV GL'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 DNV GL's staff and other resources, and its
financial viability.
++ DNV GL's capacity to adequately fund required surveys.
++ DNV GL's policies with respect to whether surveys are announced
or unannounced, to assure that surveys are unannounced.
++ DNV GL'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: April 9, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-07982 Filed 4-16-18; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16863

sooner as determined by CMS. DNV ability of the organization to provide able to acknowledge or respond to them
GL—Healthcare (DNV GL) current term continuing surveyor training. individually. We will consider all
of approval for their hospital ++ The comparability of DNV GL’s comments we receive by the date and
accreditation program expires processes to those of state agencies, time specified in the DATES section of
September 26, 2018. including survey frequency, and the this preamble, and, when we proceed
ability to investigate and respond with a subsequent document, we will
II. Provisions of the Proposed Notice appropriately to complaints against respond to the comments in the
A. Approval of Deeming Organizations accredited facilities. preamble to that document.
++ DNV GL’s processes and Dated: April 9, 2018.
Section 1865(a)(2) of the Act and our
procedures for monitoring a hospital
regulations at § 488.5 require that our Seema Verma,
found out of compliance with the DNV
findings concerning review and Administrator, Centers for Medicare &
GL’s program requirements. These
approval of a national accrediting Medicaid Services.
monitoring procedures are used only
organization’s requirements consider, [FR Doc. 2018–07982 Filed 4–16–18; 8:45 am]
when the DNV GL identifies
among other factors, the applying BILLING CODE 4120–01–P
noncompliance. If noncompliance is
accrediting organization’s requirements
identified through validation reviews or
for accreditation; survey procedures;
complaint surveys, the state survey
resources for conducting required DEPARTMENT OF HEALTH AND
agency monitors corrections as specified
surveys; capacity to furnish information HUMAN SERVICES
at § 488.9(c).
for use in enforcement activities;
++ DNV GL’s capacity to report Food and Drug Administration
monitoring procedures for provider
deficiencies to the surveyed facilities
entities found not in compliance with
and respond to the facility’s plan of
the conditions or requirements; and [Docket No. FDA–2014–N–2294]
correction in a timely manner.
ability to provide us with the necessary ++ DNV GL’s capacity to provide CMS
data for validation. Agency Information Collection
with electronic data and reports
Section 1865(a)(3)(A) of the Act Activities; Submission for Office of
necessary for effective validation and
further requires that we publish, within Management and Budget Review;
assessment of the organization’s survey
60 days of receipt of an organization’s Comment Request; Evaluation of the
process.
complete application, a notice Fresh Empire Campaign on Tobacco
++ The adequacy of DNV GL’s staff
identifying the national accrediting and other resources, and its financial AGENCY: Food and Drug Administration,
body making the request, describing the viability. HHS.
nature of the request, and providing at ++ DNV GL’s capacity to adequately
least a 30-day public comment period. ACTION: Notice.
fund required surveys.
We have 210 days from the receipt of a ++ DNV GL’s policies with respect to SUMMARY: The Food and Drug
complete application to publish notice whether surveys are announced or Administration (FDA) is announcing
of approval or denial of the application. unannounced, to assure that surveys are that a proposed collection of
The purpose of this proposed notice unannounced. information has been submitted to the
is to inform the public of DNV GL’s ++ DNV GL’s agreement to provide Office of Management and Budget
request for continued approval of its CMS with a copy of the most current (OMB) for review and clearance under
hospital accreditation program. This accreditation survey together with any the Paperwork Reduction Act of 1995
notice also solicits public comment on other information related to the survey (the PRA).
whether DNV GL’s requirements meet or as we may require (including corrective
exceed the Medicare conditions of DATES: Fax written comments on the
action plans). collection of information by May 17,
participation (CoPs) for hospitals.
C. Notice Upon Completion of 2018.
B. Evaluation of Deeming Authority Evaluation
Request ADDRESSES: To ensure that comments on
Upon completion of our evaluation, the information collection are received,
DNV GL submitted all the necessary including evaluation of public OMB recommends that written
materials to enable us to make a comments received as a result of this comments be faxed to the Office of
determination concerning its request for notice, we will publish a final notice in Information and Regulatory Affairs,
continued approval of its hospital the Federal Register announcing the OMB, Attn: FDA Desk Officer, Fax: 202–
accreditation program. This application result of our evaluation. 395–7285, or emailed to oira_
was determined to be complete on submission@omb.eop.gov. All
February 28, 2018. Under section III. Collection of Information comments should be identified with the
1865(a)(2) of the Act and our regulations Requirements OMB control number 0910–0788. Also
at § 488.5 (Application and re- This document does not impose include the FDA docket number found
application procedures for national information collection requirements, in brackets in the heading of this
accrediting organizations), our review that is, reporting, recordkeeping or document.
and evaluation of DNV GL will be third-party disclosure requirements.
FOR FURTHER INFORMATION CONTACT:
conducted in accordance with, but not Consequently, there is no need for
necessarily limited to, the following Amber Sanford, Office of Operations,
review by the Office of Management and
factors: Food and Drug Administration, Three
Budget under the authority of the
daltland on DSKBBV9HB2PROD with NOTICES

• The equivalency of DNV GL’s White Flint North, 10A–12M, 11601
Paperwork Reduction Act of 1995 (44
standards for hospitals as compared Landsdown St., North Bethesda, MD
U.S.C. Chapter 35).
with CMS’ hospital CoPs. 20852, 301–796–8867, PRAStaff@
• DNV GL’s survey process to IV. Response to Comments fda.hhs.gov.
determine the following: Because of the large number of public SUPPLEMENTARY INFORMATION: In
++ The composition of the survey comments we normally receive on compliance with 44 U.S.C. 3507, FDA
team, surveyor qualifications, and the Federal Register documents, we are not has submitted the following proposed

VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1

Document Created: 2018-04-17 02:52:01
Document Modified: 2018-04-17 02:52:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with request for comment.
Dates		To be assured consideration, comments must be received at one of
Contact		Karena Meushaw (410) 786-6609, Patricia Chmielewski, (410) 786-6899 or Monda Shaver, (410) 786-3410.
FR Citation		83 FR 16862

83 FR 16862 - Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 83, Issue 74 (April 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services