Medicare and Medicaid Programs: Application From DNV-GL Healthcare USA, Inc. for Continued Approval of its Critical Access Hospital Accreditation Program, 29723-29724 [2020-10632]
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Notices
surveillance with the Emerging
Infections Program states, and assists
with coordination of other surveillance
platforms that include bacterial
respiratory diseases; (5) provides
reference and diagnostic activities for
respiratory bacterial diseases and for the
identification of unknown gram positive
cocci; (6) develops and evaluates new
diagnostic methods for bacterial
respiratory pathogens; (7) develops,
maintains, and implements genetic
analyses of bacteria to enhance
surveillance programs, outbreak
investigations, and public health
research; and (8) collaborates with other
CDC groups, state and federal agencies,
ministries of health, WHO, PAHO,
private industry, academia, and other
governmental organizations involved in
public health.
Meningitis and Vaccine Preventable
Disease Branch (CVGGC). (1) Provides
assistance in control of endemic and
epidemic disease and exploits
opportunities to improve control and
prevention of bacterial illness including:
disease due to Neisseria meningitidis,
Haemophilus influenzae infections,
diphtheria, pertussis, tetanus, and
bacterial meningitis syndrome; (2)
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diseases; (3) provides cross-cutting
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implements and evaluates prevention
strategies for these bacterial diseases; (4)
develops, implements, and evaluates
vaccines and vaccine candidates for
these bacterial diseases; (5) conducts
surveillance and epidemiological
research for meningococcal disease, H.
influenzae infections, diphtheria,
pertussis, tetanus, and bacterial
meningitis syndrome; (6) maintains
WHO Collaborating Center for Control
and Prevention of Epidemic Meningitis;
and (7) collaborates with other CDC
groups, state and federal agencies,
ministries of health, WHO, PAHO,
private industry, and other
governmental organizations involved in
public health
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
jbell on DSKJLSW7X2PROD with NOTICES
[FR Doc. 2020–10598 Filed 5–15–20; 8:45 am]
BILLING CODE 4163–18–P
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Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
29723
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with request for
comment.
Caecilia Blondiaux, (410) 786–2190.
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: https://
www.regulations.gov . Follow the search
instructions on that website to view
public comments.
This proposed notice
acknowledges the receipt of an
application from DNV–GL Healthcare
USA, Inc. 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 June 17, 2020.
ADDRESSES: In commenting, please refer
to file code CMS–3399–PN
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 https://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–3399–PN, P.O. Box 8010,
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–3399–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
[Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by following
the instructions at the end of the
‘‘Collection of Information
Requirements’’ section in this
document.]
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a critical access hospital
(CAH), provided that certain
requirements are met by the CAH.
Section 1861(mm) of the Social Security
Act (the Act), establishes distinct
criteria for facilities seeking designation
as a CAH. 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.
However, there is an alternative to
surveys by state agencies. Section
1865(a)(1) of the Act states, if a provider
entity demonstrates through
accreditation by an 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 Centers
for Medicare & Medicaid Services (CMS)
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
Centers for Medicare & Medicaid
Services
[CMS–3399–PN]
Medicare and Medicaid Programs:
Application From DNV–GL Healthcare
USA, Inc. for Continued Approval of its
Critical Access Hospital Accreditation
Program
AGENCY:
SUMMARY:
PO 00000
Frm 00045
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Sfmt 4703
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 96 / Monday, May 18, 2020 / Notices
under part 488, subpart A, must provide
us 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 AO are set forth at
§ 488.5. The regulations at
§ 488.5(e)(2)(i) require an AO to reapply
for continued approval of its
accreditation program every 6 years or
as determined by CMS.
The DNV–GL Healthcare USA, Inc.
(DNV–GL) current term of approval for
their hospital accreditation program
expires December 23, 2020.
II. Approval of Accreditation
Organizations
Section 1865(a)(2) of the Act and our
regulations at § 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 DNV–GL’s
request for continued approval of its
CAH accreditation program. This notice
also solicits public comment on whether
the DNV–GL’s requirements meet or
exceed the Medicare conditions of
participation (CoPs) for CAHs.
jbell on DSKJLSW7X2PROD with NOTICES
III. 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 CAH
accreditation program. This application
was determined to be complete on
March 17, 2020. Under 1865(a)(2) of the
Act and our regulations at § 488.5
(Application and re-application
procedures for national AO), our review
and evaluation of the DNV–GL will be
conducted in accordance with, but not
VerDate Sep<11>2014
18:03 May 15, 2020
Jkt 250001
necessarily limited to, the following
factors:
• The equivalency of the DNV–GL’s
standards for hospitals as compared
with CMS’ CAH CoPs.
• The 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 the 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 CAH found
out of compliance with 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 § 488.9.
++ 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 the 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 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.
++ 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).
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 3501 et seq.).
V. 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.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
Evell J. Barco Holland, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: May 7, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–10632 Filed 5–15–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
SUMMARY:
E:\FR\FM\18MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Notices]
[Pages 29723-29724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10632]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3399-PN]
Medicare and Medicaid Programs: Application From DNV-GL
Healthcare USA, Inc. for Continued Approval of its Critical Access
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 USA, Inc. 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 June 17, 2020.
ADDRESSES: In commenting, please refer to file code CMS-3399-PN
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 https://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-3399-PN, P.O. Box 8010,
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-3399-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
[Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.]
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Caecilia Blondiaux, (410) 786-2190.
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: https://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 that
certain requirements are met by the CAH. Section 1861(mm) of the Social
Security Act (the Act), establishes distinct criteria for facilities
seeking designation as a CAH. 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.
However, there is an alternative to surveys by state agencies.
Section 1865(a)(1) of the Act states, if a provider entity demonstrates
through accreditation by an 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 Centers for Medicare & Medicaid
Services (CMS) 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
[[Page 29724]]
under part 488, subpart A, must provide us 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 AO are set forth at Sec.
488.5. The regulations at Sec. 488.5(e)(2)(i) require an AO to reapply
for continued approval of its accreditation program every 6 years or as
determined by CMS.
The DNV-GL Healthcare USA, Inc. (DNV-GL) current term of approval
for their hospital accreditation program expires December 23, 2020.
II. Approval of Accreditation 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
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 DNV-
GL's request for continued approval of its CAH accreditation program.
This notice also solicits public comment on whether the DNV-GL's
requirements meet or exceed the Medicare conditions of participation
(CoPs) for CAHs.
III. 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 CAH
accreditation program. This application was determined to be complete
on March 17, 2020. Under 1865(a)(2) of the Act and our regulations at
Sec. 488.5 (Application and re-application procedures for national
AO), our review and evaluation of the DNV-GL will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of the DNV-GL's standards for hospitals as
compared with CMS' CAH CoPs.
The 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 the 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 CAH found out
of compliance with 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.
++ 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 the 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 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.
++ 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).
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 3501 et seq.).
V. 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.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Seema Verma, having reviewed and approved this document,
authorizes Evell J. Barco Holland, who is the Federal Register Liaison,
to electronically sign this document for purposes of publication in the
Federal Register.
Dated: May 7, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-10632 Filed 5-15-20; 8:45 am]
BILLING CODE 4120-01-P
