Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued Deeming Authority for Hospices, 41503-41505 [2010-17405]
Download as PDF
Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices
Licensing Contact: Michael
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases, Research
Technologies Branch, Electron
Microscopy Unit, is interested in
collaborative research to further
develop, evaluate, or commercialize
potential applications of this invention,
including design and development of
instrumentation for conducting MWFS.
Please contact Barry U. Buchbinder,
Ph.D., NIAID/OTD, at 301–594–1696 or
bbuchbinder@niaid.nih.gov, for more
information.
srobinson on DSKHWCL6B1PROD with NOTICES
Treatments for Smith-Lemli-Opitz
Syndrome and Other Disorders of
Cholesterol Biosynthesis
Description of Invention: This
technology provides methods for
treating Smith-Lemli-Opitz Syndrome
and other disorders of cholesterol
biosynthesis.
Smith-Lemli-Opitz Syndrome (SLOS)
is an autosomal recessive disorder
caused by an inborn error of cholesterol
biosynthesis. It affects an estimated one
in 20,000 to 60,000 newborns, and is
most prevalent in Caucasians of Central
European ancestry. It is characterized by
distinctive facial features, microcephaly,
mental retardation or learning
disabilities, and behavioral problems, as
well as malformations in many parts of
the body, such as the heart, lungs,
kidneys, gastrointestinal tract, and
genitalia. However, the clinical
manifestations of this disease can vary
widely, ranging from relatively
moderate symptoms to profoundly
severe and life-threatening symptoms.
At least 95% of SLOS patients present
with some degree of mental retardation
and learning disability.
Biochemically, SLOS is caused by
disruption of the DHCR7 gene, which is
responsible for the final step in the
production of cholesterol; this results in
low cholesterol levels and an
accumulation of toxic byproducts of
cholesterol biosynthesis in the blood,
nervous system, and other tissues.
Supplementary dietary cholesterol is
provided to SLOS patients, but is often
of limited clinical benefit; because
levels of byproducts remain high, they
may interfere with the uptake of free
cholesterol.
Although some of the behavioral and
learning problems are due to
developmental problems, a portion of
these symptoms are likely due to a
biochemical disturbance. That
biochemical disturbance is potentially
treatable.
VerDate Mar<15>2010
18:00 Jul 15, 2010
Jkt 220001
In their recent work, the inventors
have discovered that the accumulation
in SLOS cells of the cholesterol
precursor 7–DHC causes abnormal
sphingolipid storage and transport,
resulting in a cellular phenotype similar
to that observed in the lysosomal storage
disease Niemann-Pick type C (NPC).
They have also discovered that
treatment with inhibitors of
sphingolipid biosynthesis corrects these
abnormalities, and thus such inhibitors
are of potential therapeutic benefit for
the treatment of SLOS, as well as for
other diseases exhibiting similar defects
in sphingolipid trafficking.
This technology claims compounds
that inhibit sphingolipid biosynthesis
for use in treating diseases which have
a secondary Niemann-Pick type C
disease-like cellular phenotype,
including SLOS, as well as methods of
treatment and pharmaceutical
compositions.
Applications: Development of
therapeutics for Smith-Lemli-Opitz
Syndrome and other diseases which
have a secondary Niemann-Pick type C
disease-like cellular phenotype, which
includes inborn errors of cholesterol
biosynthesis, Huntington’s disease,
cystic fibrosis, and autism.
Development Status: In vitro studies
have been performed using a
sphingolipid biosynthesis inhibitor.
Inventors: Forbes D. Porter et al.
(NICHD).
Related Publications:
1. FD Porter. Malformation syndromes
due to inborn errors of cholesterol
synthesis. J Clin Invest. 2002 Sep 15;
110(6):715–724. [PubMed: 12235098]
2. XS Jiang et al. Quantitative
proteomic analysis of inborn errors of
cholesterol synthesis: Identification of
altered metabolic pathways in DHCR7
and SC5D deficiency. Mol Cell
Proteomics. 2010 Mar 19; Epub ahead of
print. [PubMed: 20305089]
3. XS Jiang et al. Activation of Rho
GTPases in Smith-Lemli-Opitz
syndrome: pathophysiological and
clinical implications. Hum Mol Genet.
2010 Apr 1;19(7):1347–1357. [PubMed:
20067919]
4. Tierney et al. Analysis of shortterm behavioral effects of dietary
cholesterol supplementation in SmithLemli-Opitz syndrome. Am J Med Genet
A. 2010 Jan;152A(1):91–95. [PubMed:
20014133]
Patent Status:
• U.S. Patent Application No. 12/
666,279 filed 19 Jan 2010 (HHS
Reference No. E–206–2007/0–US–06).
• Related International patent
applications.
Licensing Status: Available for
licensing.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
41503
Licensing Contact: Tara Kirby, Ph.D.;
301–435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Child Health
and Human Development, Section on
Molecular Dysmorphology, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize this technology. Please
contact Alan Hubbs, Ph.D. at 301–594–
4263 or hubbsa@mail.nih.gov for more
information.
Dated: July 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–17428 Filed 7–15–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2900–FN2]
Medicare and Medicaid Programs;
Approval of the Community Health
Accreditation Program for Continued
Deeming Authority for Hospices
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice of Removal of
Conditional Probationary Status.
SUMMARY: Based on our review and
observations, we have determined that
the standards and processes used by the
Community Health Accreditation
Program (CHAP) hospice accreditation
program meet or exceed our
requirements. This final notice
announces our decision to approve
without condition CHAP’s request for
continued recognition as a national
accreditation program for hospices
seeking to participate in the Medicare or
Medicaid programs.
DATES: Effective Date: This final notice
is effective November 20, 2009 through
November 20, 2012.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski (410) 786–6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a hospice, provided certain
requirements are met. Section
1861(dd)(1) of the Social Security Act
(the Act) establishes distinct criteria for
entities seeking designation as a hospice
E:\FR\FM\16JYN1.SGM
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srobinson on DSKHWCL6B1PROD with NOTICES
41504
Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices
program. Under this authority, the
regulations at 42 CFR part 418 specify
the conditions that a hospice must meet
in order to participate in the Medicare
program, the scope of covered services,
and the conditions for Medicare
payment for hospice care. Provider
agreement regulations are located in 42
CFR part 489 and regulations pertaining
to the survey and certification of
facilities are located in 42 CFR part 488.
Generally, in order to enter into an
agreement, a hospice facility must first
be certified by a State survey agency as
complying with conditions or
requirements set forth in part 418 of our
regulations. Then, the hospice 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 accreditation organization (AO)
that all applicable Medicare conditions
or requirements are met or exceeded, we
may deem those provider entities as
having met the requirements.
Accreditation by an AO is voluntary and
is not required for Medicare
participation.
A national AO applying for approval
of deeming authority 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 re-approval
of AOs are set forth at § 488.4 and
§ 488.8(d)(3). The regulations at
§ 488.8(d)(3) require AOs to reapply for
continued approval of deeming
authority every 6 years, or sooner as
determined by CMS. The regulation at
§ 488.8(f)(3)(i) provides CMS the
authority to grant conditional approval
of an AO’s deeming authority, with a
probationary period of up to 180 days,
if the AO has not adopted comparable
standards during the reapplication
process.
We received a complete application
from CHAP for continued recognition as
a national AO for hospices on March 27,
2009. In accordance with the
requirements at § 488.4 and
§ 488.8(d)(3), we published a proposed
notice on May 22, 2009 (74 FR 24015)
and a final notice announcing our
decision to conditionally approve
CHAP’s hospice program subject to
probationary conditions on October 23,
2009 (74 FR 54832). This final notice
provides CMS’ final determination in
response to the conditional approval
with a 180-day probationary period
VerDate Mar<15>2010
18:00 Jul 15, 2010
Jkt 220001
granted to CHAP on October 23, 2009.
This notice is required to be published
no later than July 18, 2010.
II. Deeming Applications Approval
Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of deeming applications
is conducted in a timely manner. The
Act provides us with 210 calendar days
after the date of receipt of an application
to complete our survey activities and
application review process. Within 60
days of receiving a completed
application, we must publish a notice in
the Federal Register that identifies the
national accreditation body making the
request, describes the request, and
provides no less than a 30-day public
comment period. At the end of the 210day period, we must publish a notice in
the Federal Register of our approval or
denial of the application. In accordance
with § 488.8(f)(2), if CMS determines
following the deeming authority review
that the organization has failed to adopt
requirements comparable to CMS
requirements, the AO may be given a
conditional approval of its deeming
authority for a probationary period of up
to 180 days to adopt comparable
requirements. Within 60 days after the
end of this period, we must make a final
determination as to whether or not the
CHAP accreditation program for
hospices is comparable to CMS
requirements and issue an appropriate
notice that includes our reasons for our
determination.
III. Provisions of the October 23, 2009
Final Notice
Our review of CHAP’s renewal
application for hospice deeming
authority revealed that CHAP had ongoing, serious, widespread areas of noncompliance. Specifically, CHAP’s
inability to provide us with accurate,
timely data on deemed providers; lack
of complete and accurate deemed
facility survey files; and, failure to
ensure that recertification surveys are
conducted on an interval not exceeding
36 months. Due to the significant
number of areas of noncompliance
identified during the review of CHAP’s
deeming authority, we conditionally
approved CHAP’s hospice accreditation
program with a 180 day probationary
period. Under 1865(a)(2) of the Act and
our regulations at § 488.4 and § 488.8,
we conducted a comparability review of
CHAP’s hospice accreditation program
to determine compliance with Medicare
requirements for hospices at 42 CFR
part 418.
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Frm 00075
Fmt 4703
Sfmt 4703
IV. Provisions of the Final Notice
A. Differences Between CHAP’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
During the 180 day probationary
period, we conducted a comparison of
CHAP’s accreditation requirements for
hospices to our current Medicare
conditions of Participation (CoPs) as
outlined in the State Operations Manual
(SOM). We also conducted a corporate
onsite visit to validate proper
application of the requirements. Our
review and evaluation of CHAP’s
deeming application yielded the
following:
• CHAP’s survey files were complete,
accurate, and consistent with the
requirements at § 488.6(a).
• CHAP’s recertification surveys for
hospices are conducted no later than 36
months after the date of the previous
standard survey in accordance with the
requirements at § 488.20(a).
• CHAP’s data submission are
accurate, complete and timely in
accordance with the requirements at
§ 488.4(b).
• CHAP met the requirements at
section 2728 of the SOM by developing
an electronic plan of correction that
specifically addressed the ‘‘who, what,
when, and how’’ the hospice would
correct each deficiency cited and ensure
ongoing compliance.
• CHAP met requirements at
§ 488.28(a) and section 2728 of the SOM
as evidenced by review of the survey
files.
• CHAP policy regarding
establishment of an effective date for
new providers is consistent with the
requirements at § 488.13.
B. Term of Approval
Based on the review and observations,
we have determined that CHAP’s
hospice accreditation program meets or
exceeds our requirements. Therefore, we
approve CHAP as a national AO for
hospices that request participation in
the Medicare program, effective
November 20, 2009 through November
20, 2012. Under § 488.8(f)(4), notice was
given to CHAP on October 23, 2009 (74
FR 54832).
V. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
E:\FR\FM\16JYN1.SGM
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Federal Register / Vol. 75, No. 136 / Friday, July 16, 2010 / Notices
41505
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: July 12, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: July 9, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–17432 Filed 7–15–10; 8:45 am]
[FR Doc. 2010–17357 Filed 7–15–10; 8:45 am]
Dated: June 29, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating
Officer, Centers for Medicare & Medicaid
Services.
BILLING CODE 4140–01–P
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institutes of Health
[FR Doc. 2010–17405 Filed 7–15–10; 8:45 am]
BILLING CODE 4120–01–P
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (NCEH/ATSDR)
ATSDR–263; Notice of National
Conversation on Public Health and
Chemical Exposures Leadership
Council Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
srobinson on DSKHWCL6B1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Environmental Health
Sciences Review Committee.
Date: August 10–12, 2010.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Conference
Rooms A, B, and C, Research Triangle Park,
NC 27709.
Contact Person: Linda K Bass, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat’l Institute of
Environmental Health Sciences, P.O. Box
12233, MD EC–30, Research Triangle Park,
NC 27709, (919) 541–1307.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
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National Institutes of Health, HHS)
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Time and Date: 1 p.m.–5 p.m. EDT,
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Location: Teleconference.
Status: The public is invited to listen
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Purpose: This is the fifth meeting of
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Meeting Agenda: The meeting will
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Contact for Additional Information: If
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by phone, please contact:
nationalconversation@cdc.gov or Ben
Gerhardstein at 770–488–3646.
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
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The meetings will be closed to the
public in accordance with the
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552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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E:\FR\FM\16JYN1.SGM
16JYN1
Agencies
[Federal Register Volume 75, Number 136 (Friday, July 16, 2010)]
[Notices]
[Pages 41503-41505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17405]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2900-FN2]
Medicare and Medicaid Programs; Approval of the Community Health
Accreditation Program for Continued Deeming Authority for Hospices
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice of Removal of Conditional Probationary Status.
-----------------------------------------------------------------------
SUMMARY: Based on our review and observations, we have determined that
the standards and processes used by the Community Health Accreditation
Program (CHAP) hospice accreditation program meet or exceed our
requirements. This final notice announces our decision to approve
without condition CHAP's request for continued recognition as a
national accreditation program for hospices seeking to participate in
the Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective November 20, 2009
through November 20, 2012.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786-0310.
Patricia Chmielewski (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice, provided certain requirements are met.
Section 1861(dd)(1) of the Social Security Act (the Act) establishes
distinct criteria for entities seeking designation as a hospice
[[Page 41504]]
program. Under this authority, the regulations at 42 CFR part 418
specify the conditions that a hospice must meet in order to participate
in the Medicare program, the scope of covered services, and the
conditions for Medicare payment for hospice care. Provider agreement
regulations are located in 42 CFR part 489 and regulations pertaining
to the survey and certification of facilities are located in 42 CFR
part 488.
Generally, in order to enter into an agreement, a hospice facility
must first be certified by a State survey agency as complying with
conditions or requirements set forth in part 418 of our regulations.
Then, the hospice 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
accreditation organization (AO) that all applicable Medicare conditions
or requirements are met or exceeded, we may deem those provider
entities as having met the requirements. Accreditation by an AO is
voluntary and is not required for Medicare participation.
A national AO applying for approval of deeming authority 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 re-approval of AOs are set forth at Sec. 488.4 and Sec.
488.8(d)(3). The regulations at Sec. 488.8(d)(3) require AOs to
reapply for continued approval of deeming authority every 6 years, or
sooner as determined by CMS. The regulation at Sec. 488.8(f)(3)(i)
provides CMS the authority to grant conditional approval of an AO's
deeming authority, with a probationary period of up to 180 days, if the
AO has not adopted comparable standards during the reapplication
process.
We received a complete application from CHAP for continued
recognition as a national AO for hospices on March 27, 2009. In
accordance with the requirements at Sec. 488.4 and Sec. 488.8(d)(3),
we published a proposed notice on May 22, 2009 (74 FR 24015) and a
final notice announcing our decision to conditionally approve CHAP's
hospice program subject to probationary conditions on October 23, 2009
(74 FR 54832). This final notice provides CMS' final determination in
response to the conditional approval with a 180-day probationary period
granted to CHAP on October 23, 2009. This notice is required to be
published no later than July 18, 2010.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of deeming applications is conducted in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of an application to complete our survey activities and
application review process. Within 60 days of receiving a completed
application, we must publish a notice in the Federal Register that
identifies the national accreditation 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 of our approval or denial of the
application. In accordance with Sec. 488.8(f)(2), if CMS determines
following the deeming authority review that the organization has failed
to adopt requirements comparable to CMS requirements, the AO may be
given a conditional approval of its deeming authority for a
probationary period of up to 180 days to adopt comparable requirements.
Within 60 days after the end of this period, we must make a final
determination as to whether or not the CHAP accreditation program for
hospices is comparable to CMS requirements and issue an appropriate
notice that includes our reasons for our determination.
III. Provisions of the October 23, 2009 Final Notice
Our review of CHAP's renewal application for hospice deeming
authority revealed that CHAP had on-going, serious, widespread areas of
non-compliance. Specifically, CHAP's inability to provide us with
accurate, timely data on deemed providers; lack of complete and
accurate deemed facility survey files; and, failure to ensure that
recertification surveys are conducted on an interval not exceeding 36
months. Due to the significant number of areas of noncompliance
identified during the review of CHAP's deeming authority, we
conditionally approved CHAP's hospice accreditation program with a 180
day probationary period. Under 1865(a)(2) of the Act and our
regulations at Sec. 488.4 and Sec. 488.8, we conducted a
comparability review of CHAP's hospice accreditation program to
determine compliance with Medicare requirements for hospices at 42 CFR
part 418.
IV. Provisions of the Final Notice
A. Differences Between CHAP's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
During the 180 day probationary period, we conducted a comparison
of CHAP's accreditation requirements for hospices to our current
Medicare conditions of Participation (CoPs) as outlined in the State
Operations Manual (SOM). We also conducted a corporate onsite visit to
validate proper application of the requirements. Our review and
evaluation of CHAP's deeming application yielded the following:
CHAP's survey files were complete, accurate, and
consistent with the requirements at Sec. 488.6(a).
CHAP's recertification surveys for hospices are conducted
no later than 36 months after the date of the previous standard survey
in accordance with the requirements at Sec. 488.20(a).
CHAP's data submission are accurate, complete and timely
in accordance with the requirements at Sec. 488.4(b).
CHAP met the requirements at section 2728 of the SOM by
developing an electronic plan of correction that specifically addressed
the ``who, what, when, and how'' the hospice would correct each
deficiency cited and ensure ongoing compliance.
CHAP met requirements at Sec. 488.28(a) and section 2728
of the SOM as evidenced by review of the survey files.
CHAP policy regarding establishment of an effective date
for new providers is consistent with the requirements at Sec. 488.13.
B. Term of Approval
Based on the review and observations, we have determined that
CHAP's hospice accreditation program meets or exceeds our requirements.
Therefore, we approve CHAP as a national AO for hospices that request
participation in the Medicare program, effective November 20, 2009
through November 20, 2012. Under Sec. 488.8(f)(4), notice was given to
CHAP on October 23, 2009 (74 FR 54832).
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
[[Page 41505]]
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: June 29, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare
& Medicaid Services.
[FR Doc. 2010-17405 Filed 7-15-10; 8:45 am]
BILLING CODE 4120-01-P