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, 70975-70976 [2019-27836]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
the program, CMS is requiring
contractors to submit semi-annual cost
reports. The purpose of the cost reports
is to enable the ESRD Networks to
report costs in a standardized manner.
This will allow CMS to review, compare
and project ESRD Network costs during
the life of the contract. Form Number:
CMS–685 (OMB Control Number: 0938–
0657); Frequency: Reporting—Semiannually; Affected Public: Not-for-profit
institutions; Number of Respondents:
18; Total Annual Responses: 36; Total
Annual Hours: 108. (For policy
questions regarding this collection
contact Benjamin Bernstein at 410–786–
6570).
Dated: December 19, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–27822 Filed 12–23–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3377–FN]
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
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve 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: This final notice is effective
December 27, 2019 through December
27, 2025.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636. Anita
Moore, (410) 786–2161.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a critical access hospital
(CAH) provided certain requirements
VerDate Sep<11>2014
16:53 Dec 23, 2019
Jkt 250001
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 § 488.5.
The regulations at § 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. The
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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
70975
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.
III. Provisions of the Proposed Notice
In the July 31, 2019 Federal Register
(84 FR 37302), we published a proposed
notice announcing AAHHS-HFAP’s
request for continued approval of its
Medicare CAH accreditation program.
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 § 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
(CoP).
• 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 AAHHSHFAP’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
E:\FR\FM\26DEN1.SGM
26DEN1
70976
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
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 § 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).
++ AAHHS-HFAP’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.
In accordance with section
1865(a)(3)(A) of the Act, the July 31,
2019 proposed notice also solicited
public comments regarding whether
AAHHS-HFAP’s requirements met or
exceeded the Medicare CoPs for CAHs.
No comments were received in response
to our proposed notice.
IV. Provisions of the Final Notice
khammond on DSKJM1Z7X2PROD with NOTICES
A. Differences Between AAHHS-HFAP’s
Standards and Requirements for
Accreditation and Medicare Conditions
and Survey Requirements
We compared AAHHS-HFAP’s CAH
accreditation requirements and survey
process with the Medicare CoPs of part
485, and the survey and certification
process requirements of parts 488 and
489. Our review and evaluation of
AAHHS-HFAP’s CAH application,
which were conducted as described in
section III of this final notice, yielded
the following areas where, as of the date
of this notice, AAHHS-HFAP has
completed revising its standards and
certification processes in order to meet
the requirements at:
VerDate Sep<11>2014
16:53 Dec 23, 2019
Jkt 250001
• § 485.623(c)(6) through
§ 485.623(c)(6)(ii), to revise its standards
to clarify that either evacuation or a fire
watch is required.
• § 485.625(d)(1)(i), to address the
requirement that initial training in
emergency preparedness policies,
procedures, including prompt reporting
and extinguishing of fire, protection,
and where necessary, evacuation of
patients, personnel, and guest, fire
prevention, and cooperation with
firefighting and disaster authorities, to
all new and existing staff, and
individuals providing services under
arrangement, and volunteers, consistent
with their expected roles.
• § 485.625(e)(3), to revise its
standard that CAHs that do not maintain
an onsite fuel source to power
emergency generators are not required
to have a plan for maintaining such fuel
source in emergency circumstances.
• § 488.26(b), to ensure that surveyors
are assessing compliance with the
hospital CoPs in CAH psychiatric and
rehabilitation Distinct Part Unit (DPUs).
B. Term of Approval
Based on our review and observations
described in section III of this final
notice, we have approved AAHHS/
HFAP’s as a national accreditation
organization for CAHs that request
participation in the Medicare program,
effective December 27, 2019 through
December 25, 2025.
V. 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).
Dated: December 11, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–27836 Filed 12–23–19; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4739]
Requesting Food and Drug
Administration Feedback on
Combination Products; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Requesting FDA Feedback on
Combination Products.’’ The purpose of
this guidance is to discuss ways in
which combination product sponsors
can obtain feedback from FDA on
scientific and regulatory questions and
to describe best practices for FDA and
sponsors when interacting on these
topics. These interactions can occur
through application-based mechanisms,
such as the pre-submission process used
in the Center for Devices and
Radiological Health (CDRH) and the
Center for Biologics and Research
(CBER) and the formal meetings used in
the Center for Drug Evaluation and
Research (CDER) and CBER, or through
Combination Product Agreement
Meetings (CPAMs), as appropriate.
DATES: Submit either electronic or
written comments on the draft guidance
by February 24, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70975-70976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3377-FN]
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: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve 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: This final notice is effective December 27, 2019 through
December 27, 2025.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636.
Anita Moore, (410) 786-2161.
SUPPLEMENTARY INFORMATION:
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. The 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.
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.
III. Provisions of the Proposed Notice
In the July 31, 2019 Federal Register (84 FR 37302), we published a
proposed notice announcing AAHHS-HFAP's request for continued approval
of its Medicare CAH accreditation program. 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 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 CAHs as
compared with CMS' CAH conditions of participation (CoP).
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
[[Page 70976]]
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 Sec. 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).
++ AAHHS-HFAP'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.
In accordance with section 1865(a)(3)(A) of the Act, the July 31,
2019 proposed notice also solicited public comments regarding whether
AAHHS-HFAP's requirements met or exceeded the Medicare CoPs for CAHs.
No comments were received in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAHHS-HFAP's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared AAHHS-HFAP's CAH accreditation requirements and survey
process with the Medicare CoPs of part 485, and the survey and
certification process requirements of parts 488 and 489. Our review and
evaluation of AAHHS-HFAP's CAH application, which were conducted as
described in section III of this final notice, yielded the following
areas where, as of the date of this notice, AAHHS-HFAP has completed
revising its standards and certification processes in order to meet the
requirements at:
Sec. 485.623(c)(6) through Sec. 485.623(c)(6)(ii), to
revise its standards to clarify that either evacuation or a fire watch
is required.
Sec. 485.625(d)(1)(i), to address the requirement that
initial training in emergency preparedness policies, procedures,
including prompt reporting and extinguishing of fire, protection, and
where necessary, evacuation of patients, personnel, and guest, fire
prevention, and cooperation with firefighting and disaster authorities,
to all new and existing staff, and individuals providing services under
arrangement, and volunteers, consistent with their expected roles.
Sec. 485.625(e)(3), to revise its standard that CAHs that
do not maintain an onsite fuel source to power emergency generators are
not required to have a plan for maintaining such fuel source in
emergency circumstances.
Sec. 488.26(b), to ensure that surveyors are assessing
compliance with the hospital CoPs in CAH psychiatric and rehabilitation
Distinct Part Unit (DPUs).
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we have approved AAHHS/HFAP's as a national
accreditation organization for CAHs that request participation in the
Medicare program, effective December 27, 2019 through December 25,
2025.
V. 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).
Dated: December 11, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-27836 Filed 12-23-19; 8:45 am]
BILLING CODE 4120-01-P
