Medicare and Medicaid Programs; Approval of the Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Program, 12769-12770 [2018-05891]
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12769
Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
police departments, sheriff’s
departments, or similar governmental
organizations throughout the
continental United States. One thousand
five LEO volunteers will participate in
the study over three years, with a study
goal of obtaining complete
anthropometric assessment of 1,000
LEOs. Information collection for each
respondent is expected to take no longer
than 63 minutes (total) to complete.
Participation is voluntary and there are
no costs to the respondents other than
their time. The total estimated
annualized burden hours are 353.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Law Enforcement Officers ..............................
Law Enforcement Officers ..............................
Law Enforcement Officers ..............................
Biographical Information ................................
Data Sheet .....................................................
Assessment of Challenges in Vehicle and
with Body Armor.
Two-dimensional Hand Scan and Three-dimensional Body Scans.
Law Enforcement Officers ..............................
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–05911 Filed 3–22–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3349–FN]
Medicare and Medicaid Programs;
Approval of the Community Health
Accreditation Partner for Continued
CMS Approval of Its Home Health
Agency Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces our
decision to approve the Community
Health Accreditation Partner (CHAP) for
continued recognition as a national
accrediting organization for home health
agencies (HHAs) that wish to participate
in the Medicare or Medicaid programs.
DATES: This notice is applicable March
31, 2018 through March 31, 2024.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams (410) 786–8636, Monda
Shaver, (410) 786–3410, or Patricia
Chmielewski (410) 786–6899.
SUPPLEMENTARY INFORMATION:
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
21:54 Mar 22, 2018
Jkt 244001
Number of
respondents
Act) establish distinct criteria for
entities 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 agencies
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
conditions or requirements set forth in
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 organization’s
approved program may 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
335
335
335
1
1
1
3/60
25/60
5/60
335
1
30/60
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. Section 488.5(e)(2)(i) requires
accrediting organizations to reapply for
continued approval of its Medicare
accreditation program every 6 years or
sooner as determined by CMS. The
Community Health Accreditation
Partner’s (CHAP’S) term of approval as
a recognized accreditation program for
HHAs expires March 31, 2018.
II. Approval of Accreditation
Organizations
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of applications for CMSapproval of an accreditation program is
conducted in a timely manner. The Act
provides us 210 days after the date of
receipt of a complete application, with
any documentation necessary to make
the determination, to complete our
survey activities and application
process. Within 60 days of receiving a
completed application, we must publish
a notice in the Federal Register that
identifies the national accrediting body
making the request, describes the
request, and provides no less than a 30day public comment period. At the end
of the 210-day period, we must publish
a notice in the Federal Register
approving or denying the application.
III. Proposed Notice
On October 20, 2017, we published a
proposed notice in the Federal Register
(82 FR 48817) announcing CHAP’s
request for continued approval of its
Medicare HHA accreditation program.
In the proposed notice, we detailed our
evaluation criteria. Under section
1865(a)(2) of the Act and § 488.5, we
E:\FR\FM\23MRN1.SGM
23MRN1
amozie on DSK30RV082PROD with NOTICES
12770
Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices
conducted a review of CHAP’s Medicare
HHA application in accordance with the
criteria specified by our regulations,
which include, but are not limited to the
following:
• An onsite administrative review of
CHAP’s: (1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to
investigate and respond appropriately to
complaints against HHAs; and (5)
survey review and decision-making
process for accreditation;
• A comparison of CHAP’s HHA
accreditation standards to our current
Medicare HHA conditions for
participation (CoPs);
• A documentation review of CHAP’s
survey processes to:
++ Determine the composition of the
survey team, surveyor qualifications,
and CHAP’s ability to provide
continuing surveyor training.
++ Compare CHAP’s processes to
those we require of state survey
agencies, including periodic resurvey
and the ability to investigate and
respond appropriately to complaints
against accredited HHAs.
++ Evaluate CHAP’s procedures for
monitoring HHAs found to be out of
compliance with CHAP program
requirements. This pertains only to
monitoring procedures when CHAP
identifies non-compliance. If noncompliance is identified by a state
survey agency through a validation
survey, the state survey agency monitors
corrections as specified at § 488.9(c)➢
++ Assess CHAP’s ability to report
deficiencies to the surveyed HHAs and
respond to the HHA’s plan of correction
in a timely manner.
++ Establish CHAP’s ability to
provide CMS with electronic data and
reports necessary for effective validation
and assessment of the organization’s
survey process.
++ Determine the adequacy of
CHAP’s staff and other resources.
++ Confirm CHAP’s ability to provide
adequate funding for the completion of
required surveys.
++ Confirm CHAP’s policies for
surveys being unannounced.
++ Obtain CHAP’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.
In accordance with section
1865(a)(3)(A) of the Act, the October 20,
2017 proposed notice (82 FR 48817) also
solicited public comments regarding
whether CHAP’s requirements met or
VerDate Sep<11>2014
21:54 Mar 22, 2018
Jkt 244001
exceeded the Medicare CoPs for HHAs.
There were no comments submitted.
V. Collection of Information
Requirements
IV. Provisions of the Final Notice
This document does not impose
information collection requirements,
that is, reporting, record keeping 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. 35).
A. Differences Between CHAP’s
Standards and Requirements for
Accreditation and Medicare Conditions
of Participation and Survey
Requirements
We compared CHAP’s accreditation
requirements for HHAs and its survey
process with the Medicare CoPs at 42
CFR part 484, and the survey and
certification process requirements of 42
CFR parts 488 and 489. CHAP’s
standards crosswalk, which crosswalks
CHAP standards to the corresponding
Medicare requirements and regulations,
was also examined to ensure that the
appropriate CMS regulation would be
included in citations as appropriate.
Our review and evaluation of CHAP’s
HHA 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,
CHAP has revised its survey processes
so that its processes are comparable to
CMS requirements:
• § 488.5(a)(4)(vii), to ensure plans of
corrections (PoCs) address all noncompliant practices and include policy
changes required to correct the deficient
practice.
• § 488.5(a)(7) through (9), to ensure
surveyors maintain current licensure,
that new surveyors receive the
minimum number of mentored surveys
prior to surveying independently, and
that all new surveyors receive a 90-day
evaluation of performance.
• § 488.5(a)(12), to ensure the
appropriate number of medical records
are reviewed during complaint
investigations.
• § 488.26(b), to ensure that survey
documentation includes a detailed
deficiency statement that clearly
outlines the number of medical records
reviewed, describes the manner and
degree of non-compliance, and supports
the appropriate level of deficiency
citation.
B. Term of Approval
Based on the review and observations
described in section III. of this final
notice, we have determined that CHAP’s
requirements for HHAs meet or exceed
our requirements. Therefore, we
approve CHAP as a national
accreditation organization for HHAs that
request participation in the Medicare
program, effective March 31, 2018
through March 31, 2024.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–05891 Filed 3–22–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2397–FN]
RIN–0938–ZB29
Medicaid Program; Announcement of
Medicaid Drug Rebate Program
National Rebate Agreement
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
changes to the Medicaid National Drug
Rebate Agreement (NDRA, or
Agreement) for use by the Secretary of
the Department of Health and Human
Services (HHS) and manufacturers
under the Medicaid Drug Rebate
Program (MDRP). We are updating the
NDRA to incorporate legislative and
regulatory changes that have occurred
since the Agreement was published in
the February 21, 1991 Federal Register
(56 FR 7049). We are also updating the
NDRA to make editorial and structural
revisions, such as references to the
updated Office of Management and
Budget (OMB)-approved data collection
forms and electronic data reporting.
DATES:
Applicability Date: The updated
National Medicaid Drug Rebate
Agreement (NDRA) provided in the
Addendum to this final notice will be
applicable on March 23, 2018.
Compliance Date: Publication of
CMS–2397–FN serves as written notice
of good cause to terminate all existing
rebate agreements as of the first day of
the full calendar quarter which begins at
least 6 months after the effective date of
the updated NDRA (October 1, 2018).
Manufacturers with an existing active
SUMMARY:
E:\FR\FM\23MRN1.SGM
23MRN1
Agencies
[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12769-12770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05891]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3349-FN]
Medicare and Medicaid Programs; Approval of the Community Health
Accreditation Partner for Continued CMS Approval of Its Home Health
Agency Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to approve the Community
Health Accreditation Partner (CHAP) for continued recognition as a
national accrediting organization for home health agencies (HHAs) that
wish to participate in the Medicare or Medicaid programs.
DATES: This notice is applicable March 31, 2018 through March 31, 2024.
FOR FURTHER INFORMATION CONTACT: Lillian Williams (410) 786-8636, Monda
Shaver, (410) 786-3410, or Patricia Chmielewski (410) 786-6899.
SUPPLEMENTARY INFORMATION:
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 entities
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 agencies 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 conditions or requirements set forth in 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 organization's approved program may 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. Section 488.5(e)(2)(i)
requires accrediting organizations to reapply for continued approval of
its Medicare accreditation program every 6 years or sooner as
determined by CMS. The Community Health Accreditation Partner's
(CHAP'S) term of approval as a recognized accreditation program for
HHAs expires March 31, 2018.
II. Approval of Accreditation Organizations
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for CMS-approval of an
accreditation program is conducted in a timely manner. The Act provides
us 210 days after the date of receipt of a complete application, with
any documentation necessary to make the determination, to complete our
survey activities and application process. Within 60 days of receiving
a completed application, we must publish a notice in the Federal
Register that identifies the national accrediting body making the
request, describes the request, and provides no less than a 30-day
public comment period. At the end of the 210-day period, we must
publish a notice in the Federal Register approving or denying the
application.
III. Proposed Notice
On October 20, 2017, we published a proposed notice in the Federal
Register (82 FR 48817) announcing CHAP's request for continued approval
of its Medicare HHA accreditation program. In the proposed notice, we
detailed our evaluation criteria. Under section 1865(a)(2) of the Act
and Sec. 488.5, we
[[Page 12770]]
conducted a review of CHAP's Medicare HHA application in accordance
with the criteria specified by our regulations, which include, but are
not limited to the following:
An onsite administrative review of CHAP's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against HHAs; and (5) survey review and
decision-making process for accreditation;
A comparison of CHAP's HHA accreditation standards to our
current Medicare HHA conditions for participation (CoPs);
A documentation review of CHAP's survey processes to:
++ Determine the composition of the survey team, surveyor
qualifications, and CHAP's ability to provide continuing surveyor
training.
++ Compare CHAP's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited HHAs.
++ Evaluate CHAP's procedures for monitoring HHAs found to be out
of compliance with CHAP program requirements. This pertains only to
monitoring procedures when CHAP identifies non-compliance. If non-
compliance is identified by a state survey agency through a validation
survey, the state survey agency monitors corrections as specified at
Sec. 488.9(c)[rtarr8]
++ Assess CHAP's ability to report deficiencies to the surveyed
HHAs and respond to the HHA's plan of correction in a timely manner.
++ Establish CHAP's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of CHAP's staff and other resources.
++ Confirm CHAP's ability to provide adequate funding for the
completion of required surveys.
++ Confirm CHAP's policies for surveys being unannounced.
++ Obtain CHAP'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.
In accordance with section 1865(a)(3)(A) of the Act, the October
20, 2017 proposed notice (82 FR 48817) also solicited public comments
regarding whether CHAP's requirements met or exceeded the Medicare CoPs
for HHAs. There were no comments submitted.
IV. Provisions of the Final Notice
A. Differences Between CHAP's Standards and Requirements for
Accreditation and Medicare Conditions of Participation and Survey
Requirements
We compared CHAP's accreditation requirements for HHAs and its
survey process with the Medicare CoPs at 42 CFR part 484, and the
survey and certification process requirements of 42 CFR parts 488 and
489. CHAP's standards crosswalk, which crosswalks CHAP standards to the
corresponding Medicare requirements and regulations, was also examined
to ensure that the appropriate CMS regulation would be included in
citations as appropriate. Our review and evaluation of CHAP's HHA
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, CHAP has revised its survey processes so that its processes are
comparable to CMS requirements:
Sec. 488.5(a)(4)(vii), to ensure plans of corrections
(PoCs) address all non-compliant practices and include policy changes
required to correct the deficient practice.
Sec. 488.5(a)(7) through (9), to ensure surveyors
maintain current licensure, that new surveyors receive the minimum
number of mentored surveys prior to surveying independently, and that
all new surveyors receive a 90-day evaluation of performance.
Sec. 488.5(a)(12), to ensure the appropriate number of
medical records are reviewed during complaint investigations.
Sec. 488.26(b), to ensure that survey documentation
includes a detailed deficiency statement that clearly outlines the
number of medical records reviewed, describes the manner and degree of
non-compliance, and supports the appropriate level of deficiency
citation.
B. Term of Approval
Based on the review and observations described in section III. of
this final notice, we have determined that CHAP's requirements for HHAs
meet or exceed our requirements. Therefore, we approve CHAP as a
national accreditation organization for HHAs that request participation
in the Medicare program, effective March 31, 2018 through March 31,
2024.
V. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, record keeping 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. 35).
Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-05891 Filed 3-22-18; 8:45 am]
BILLING CODE 4120-01-P