Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program, 57026-57028 [2019-23185]
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Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Annual
Eligibility Redetermination, Product
Discontinuation and Renewal Notices;
Use: Section 1411(f)(1)(B) of the
Affordable Care Act directs the
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(the Secretary) to establish procedures
to redetermine the eligibility of
individuals on a periodic basis in
appropriate circumstances. Section
1321(a) of the Affordable Care Act
provides authority for the Secretary to
establish standards and regulations to
implement the statutory requirements
related to Exchanges, qualified health
plans (QHPs) and other components of
title I of the Affordable Care Act. Under
section 2703 of the Public Health
Service Act (PHS Act), as added by the
Affordable Care Act, and former section
2712 and section 2741 of the PHS Act,
enacted by the Health Insurance
Portability and Accountability Act of
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group and individual markets must
guarantee the renewability of coverage
unless an exception applies.
The final rule ‘‘Patient Protection and
Affordable Care Act; Annual Eligibility
Redeterminations for Exchange
Participation and Insurance
Affordability Programs; Health
Insurance Issuer Standards Under the
Affordable Care Act, Including
Standards Related to Exchanges’’ (79 FR
52994), provides that an Exchange may
choose to conduct the annual
redetermination process for a plan year
(1) in accordance with the existing
procedures described in 45 CFR
155.335; (2) in accordance with
procedures described in guidance
issued by the Secretary for the coverage
year; or (3) using an alternative
proposed by the Exchange and approved
by the Secretary. The final rule also
amends the requirements for product
renewal and re-enrollment (or nonrenewal) notices to be sent by QHP
issuers in the Exchanges and specifies
content for these notices. Form Number:
CMS–10527 (OMB control number
0938–1254); Frequency: Annually;
Affected Public: Private Sector, State
Governments; Number of Respondents:
1,805; Total Annual Responses: 7,420;
Total Annual Hours: 90,331. (For policy
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17:34 Oct 23, 2019
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questions regarding this collection
contact Usree Bandyopadhyay at 410–
786–6650.)
Dated: October 18, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–23143 Filed 10–23–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3384–PN]
Medicare and Medicaid Programs;
Application From the Joint
Commission (TJC) for Continued
Approval of its Home Health Agency
Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
AGENCY:
This proposed notice
acknowledges the receipt of an
application from The Joint Commission
(TJC) for continued recognition as a
national accrediting organization for
home health agencies (HHAs) that wish
to participate in the Medicare or
Medicaid programs. The statute requires
that within 60 days of receipt of an
organization’s complete application, the
Centers for Medicare and Medicaid
Services (CMS) publish 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 November 25, 2019.
ADDRESSES: In commenting, please refer
to file code CMS–3384–PN. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four 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–3384–PN, P.O. Box 8016,
Baltimore, MD 21244–8010.
SUMMARY:
PO 00000
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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–3384–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Sharon Lash (410) 786–9457.
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.
E:\FR\FM\24OCN1.SGM
24OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services from a home health agency
(HHA), provided certain requirements
are met. Sections 1861(m) and (o), 1891
and 1895 of the Social Security Act (the
Act) establish distinct criteria for an
entity seeking designation as an HHA.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
and other entities are at 42 CFR part
488. The regulations at 42 CFR parts 409
and 484 specify the conditions that an
HHA must meet to participate in the
Medicare program, the scope of covered
services and the conditions for Medicare
payment for home health care.
Generally, to enter into a provider
agreement with the Medicare program,
an HHA must first be certified by a state
survey agency as complying with the
conditions or requirements set forth in
42 CFR part 484 of our regulations.
Thereafter, the HHA 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 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 Health
and Human Services 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
CMS approval of their accreditation
program under 42 CFR part 488, subpart
A must provide 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 accrediting organizations to
reapply for continued approval of their
accreditation program every 6 years or
sooner as determined by CMS.
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17:34 Oct 23, 2019
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The Joint Commission’s (TJC’s) term
of approval for their HHA accreditation
program expires March 31, 2020.
II. Approval of Deeming 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 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 TJC’s request
for continued approval for its HHA
accreditation program. This notice also
solicits public comment on whether
TJC’s requirements meet or exceed the
Medicare conditions of participation
(CoPs) for HHAs.
III. Evaluation of Deeming Authority
Request
TJC submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its HHA
accreditation program. This application
was determined to be complete on July
15, 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 TJC will be conducted in
accordance with, but not necessarily
limited to, the following factors:
• The equivalency of TJC’s standards
for HHAs as compared with CMS’ HHA
CoPs.
• TJC’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 TJC’s
processes to those of state agencies,
including survey frequency, and the
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57027
ability to investigate and respond
appropriately to complaints against
accredited HHAs.
++ TJC’s processes and procedures
for monitoring HHAs found out of
compliance with TJC’s program
requirements. These monitoring
procedures are used only when TJC
identifies noncompliance. If
noncompliance is identified through
validation reviews or complaint
surveys, the state survey agency
monitors corrections as specified at
§ 488.9(c).
++ TJC’s capacity to report
deficiencies to the surveyed HHAs and
respond to the HHA’s plan of correction
in a timely manner.
++ TJC’s capacity to provide us with
electronic data and reports necessary for
effective validation and assessment of
the organization’s survey process.
++ The adequacy of TJC’s staff and
other resources, and its financial
viability.
++ TJC’s capacity to adequately fund
required surveys.
++ TJC’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ TJC’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.
++ TJC’s agreement to provide us
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 thirdparty disclosure requirements.
Consequently, there is no need for
review by the Office Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
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 notice.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
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Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
Register summarizing our response to
comments and announcing the result of
our evaluation.
Dated: September 26, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–23185 Filed 10–23–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4467]
Breast Implants—Certain Labeling
Recommendations To Improve Patient
Communication; 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 the draft
guidance entitled ‘‘Breast Implants—
Certain Labeling Recommendations to
Improve Patient Communication.’’ This
draft guidance contains
recommendations concerning the
content and format for certain labeling
information for saline and silicone gelfilled breast implants. FDA is seeking
comments on all aspects of the draft
guidance, including the respective
benefits and risks of smooth and
textured breast implants and
applicability of the recommendations to
both types. This draft guidance is not
final nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by December 23, 2019 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:
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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
VerDate Sep<11>2014
17:34 Oct 23, 2019
Jkt 250001
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
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–4467 for ‘‘Breast Implants—
Certain Labeling Recommendations to
Improve Patient Communication.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
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contact information to be made publicly
available, you can provide this
PO 00000
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Fmt 4703
Sfmt 4703
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Breast Implants—
Certain Labeling Recommendations to
Improve Patient Communication’’ to the
Office of Policy, Guidance and Policy
Development, Center for Devices and
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FOR FURTHER INFORMATION CONTACT:
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Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4646, Silver Spring,
MD 20993–0002, 301–796–6891.
SUPPLEMENTARY INFORMATION:
I. Background
Over the past few years, FDA has
received new information pertaining to
risks associated with breast implants,
including breast implant-associated
anaplastic large cell lymphoma and
systemic symptoms commonly referred
to as breast implant illness that some
patients attribute to their implants. FDA
has taken several steps to better
understand and address risks associated
with breast implants, including
convening the General and Plastic
Surgery Devices Panel of the Medical
Devices Advisory Committee on March
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[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57026-57028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23185]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3384-PN]
Medicare and Medicaid Programs; Application From the Joint
Commission (TJC) for Continued Approval of its Home Health Agency
Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed notice.
-----------------------------------------------------------------------
SUMMARY: This proposed notice acknowledges the receipt of an
application from The Joint Commission (TJC) for continued recognition
as a national accrediting organization for home health agencies (HHAs)
that wish to participate in the Medicare or Medicaid programs. The
statute requires that within 60 days of receipt of an organization's
complete application, the Centers for Medicare and Medicaid Services
(CMS) publish 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 November 25,
2019.
ADDRESSES: In commenting, please refer to file code CMS-3384-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four 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-3384-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-3384-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Sharon Lash (410) 786-9457.
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.
[[Page 57027]]
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services from a home health agency (HHA), provided certain
requirements are met. Sections 1861(m) and (o), 1891 and 1895 of the
Social Security Act (the Act) establish distinct criteria for an entity
seeking designation as an HHA. Regulations concerning provider
agreements are at 42 CFR part 489 and those pertaining to activities
relating to the survey and certification of facilities and other
entities are at 42 CFR part 488. The regulations at 42 CFR parts 409
and 484 specify the conditions that an HHA must meet to participate in
the Medicare program, the scope of covered services and the conditions
for Medicare payment for home health care.
Generally, to enter into a provider agreement with the Medicare
program, an HHA must first be certified by a state survey agency as
complying with the conditions or requirements set forth in 42 CFR part
484 of our regulations. Thereafter, the HHA 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 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
Health and Human Services 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 CMS approval of their accreditation program under 42 CFR
part 488, subpart A must provide 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 their accreditation program every 6 years or
sooner as determined by CMS.
The Joint Commission's (TJC's) term of approval for their HHA
accreditation program expires March 31, 2020.
II. 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
TJC's request for continued approval for its HHA accreditation program.
This notice also solicits public comment on whether TJC's requirements
meet or exceed the Medicare conditions of participation (CoPs) for
HHAs.
III. Evaluation of Deeming Authority Request
TJC submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its HHA
accreditation program. This application was determined to be complete
on July 15, 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
TJC will be conducted in accordance with, but not necessarily limited
to, the following factors:
The equivalency of TJC's standards for HHAs as compared
with CMS' HHA CoPs.
TJC'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 TJC's processes to those of state agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited HHAs.
++ TJC's processes and procedures for monitoring HHAs found out of
compliance with TJC's program requirements. These monitoring procedures
are used only when TJC 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).
++ TJC's capacity to report deficiencies to the surveyed HHAs and
respond to the HHA's plan of correction in a timely manner.
++ TJC's capacity to provide us with electronic data and reports
necessary for effective validation and assessment of the organization's
survey process.
++ The adequacy of TJC's staff and other resources, and its
financial viability.
++ TJC's capacity to adequately fund required surveys.
++ TJC's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ TJC'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.
++ TJC's agreement to provide us 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
Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. Chapter 35).
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 notice.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a final notice in
the Federal
[[Page 57028]]
Register summarizing our response to comments and announcing the result
of our evaluation.
Dated: September 26, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-23185 Filed 10-23-19; 8:45 am]
BILLING CODE 4120-01-P