Medicare and Medicaid Programs; Application by the American Osteopathic Association for Continued Deeming Authority for Ambulatory Surgical Centers, 48974-48976 [E9-22956]
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48974
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: September 17, 2009.
Joe Ellis,
Director, OPERA, OER, National Institutes of
Health.
[FR Doc. E9–23078 Filed 9–24–09; 8:45 am]
BILLING CODE 4140–10–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0449]
Enforcement of General Tobacco
Standard Special Rule for Cigarettes
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Family Smoking Prevention and
Tobacco Control Act (FSPTCA),
establishes a tobacco standard special
rule for cigarettes. This special rule for
cigarettes prohibits a cigarette or any of
its component parts (including the
tobacco, filter, or paper) from
containing, as a constituent (including a
smoke constituent) or additive, an
artificial or natural flavor (other than
tobacco or menthol) or an herb or spice,
including strawberry, grape, orange,
clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate,
cherry, or coffee, that is a characterizing
flavor of the tobacco product or tobacco
smoke. The Food and Drug
Administration (FDA) is providing this
notice to remind regulated industry that
as of the effective date identified in the
FSPTCA, cigarettes that contain certain
characterizing flavors are considered
adulterated under the act. FDA is also
providing in this notice contact
information to which individuals who
observe violative products after the
effective date of the tobacco standard
special rule may report their
observations to FDA.
DATES: Effective September 22, 2009.
ADDRESSES: To report tobacco products
that fail to comply with section
907(a)(1)(A) of the act after September
22, 2009, please contact the Center for
Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373 or https://www.fda.gov/flavored
tobacco.
FOR FURTHER INFORMATION CONTACT:
Michele Mital, Center for Tobacco
Products, Food and Drug
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, Michele.Mital@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Smoking
is the leading preventable cause of death
in the United States. An important way
to reduce the death and disease caused
by smoking is to prevent children and
adolescents from starting to smoke.
Congress has stated that flavors make
cigarettes more appealing to youth and
often result in exposure to additional
carcinogens and other toxic
constituents. The removal from the
market of cigarettes that contain certain
characterizing flavors is an important
step in FDA’s efforts to reduce the
burden of illness and death caused by
tobacco products.
The FSPTCA provides FDA with
regulatory authority over the
manufacture, marketing, and
distribution of tobacco products.
Specifically, section 907(a)(1)(A) of the
act, as amended by the FSPTCA,
establishes a tobacco product standard
special rule for cigarettes that states in
part: ‘‘* * * a cigarette or any of its
component parts (including the tobacco,
filter, or paper) shall not contain, as a
constituent (including a smoke
constituent) or additive, an artificial or
natural flavor (other than tobacco or
menthol) or an herb or spice, including
strawberry, grape, orange, clove,
cinnamon, pineapple, vanilla, coconut,
licorice, cocoa, chocolate, cherry, or
coffee, that is a characterizing flavor of
the tobacco product or tobacco smoke.’’
This standard applies to all tobacco
products that meet the definition of a
‘‘cigarette’’ in section 900(3) of the act,
as amended, even if they are not labeled
as ‘‘cigarettes’’ or are labeled as cigars or
as some other product.
As of the September 22, 2009,
effective date, cigarettes and their
component parts that fail to comply
with the special rule established under
section 907 of the act, as amended, are
deemed adulterated under section 902
of the act, as amended. Under the act,
adulterated products sold or held for
sale in the United States may be subject
to seizure under section 304 of the act
(21 U.S.C. 334). In addition,
manufacturers, distributors, and
retailers may be subject to injunction
actions, civil money penalties, and/or
criminal prosecution for violating the
requirements of the act (sections 301,
302, and 303 of the act (21 U.S.C. 331,
332, and 333, respectively)). FDA
intends to use the full range of
enforcement tools within the agency’s
authority to ensure compliance with the
new requirement.
FDA encourages individuals who
observe violative products after
PO 00000
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Fmt 4703
Sfmt 4703
September 22, 2009, to report their
observations to FDA. This collection of
information was approved under OMB
control number 0910–0647 and expires
on March 31, 2010. Individuals may
report products in violation of this
standard to FDA through the contact
information provided in the ADDRESSES
section of this document.
Dated: September 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23144 Filed 9–22–09; 11:15 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2487–FN]
Medicare and Medicaid Programs;
Application by the American
Osteopathic Association for Continued
Deeming Authority for Ambulatory
Surgical Centers
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
SUMMARY: This final notice announces
our decision to approve the American
Osteopathic Association (AOA) for
continued recognition as a national
accreditation program for ambulatory
surgical centers (ASCs) seeking to
participate in the Medicare or Medicaid
programs.
DATES: Effective Date: This final notice
is effective on October 23, 2009 through
October 23, 2013.
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 an ambulatory surgical
center (ASC) provided certain
requirements are met. Sections
1832(a)(2)(F)(i) of the Social Security
Act (the Act) establishes distinct criteria
for facilities seeking designation as an
ASC. Under this authority, the
minimum requirements that an ASC
must meet to participate in Medicare are
set forth in regulations at 42 CFR part
416, which determine the basis and
scope of ASC covered services, and the
conditions for Medicare payment for
facility services. Regulations concerning
provider agreements are at 42 CFR part
489 and those pertaining to activities
E:\FR\FM\25SEN1.SGM
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Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
relating to the survey and certification
of facilities are at 42 CFR part 488.
Generally, to enter into an agreement,
an ASC must first be certified by a State
survey agency as complying with
conditions or requirements set forth in
part 416 of our regulations. Then, the
ASC is subject to regular surveys by a
State survey agency to determine
whether it continues to meet those
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 that
all applicable Medicare conditions are
met or exceeded, we may ‘‘deem’’ those
provider entities as having met the
requirements. Accreditation by an
accreditation organization is voluntary
and is not required for Medicare
participation.
If an accreditation organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, a
provider entity accredited by the
national accrediting body’s approved
program may be deemed to meet the
Medicare conditions. A national
accreditation organization applying for
approval of deeming authority under
part 488, subpart A, must provide us
with reasonable assurance that the
accreditation organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning re-approval
of accrediting organizations are set forth
at § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require
accreditation organizations to reapply
for continued approval of deeming
authority every 6 years, or sooner as we
determine.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 that a 30-day public
comment period. At the end of the 210day period, we must publish an
approval or denial of the application.
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
III. Provisions of the Proposed Notice
On May 26, 2009, we published a
proposed notice (74 FR 24857)
announcing the American Osteopathic
Association’s (AOA) request for reapproval as a deeming organization for
ASCs. In the proposed notice, we
detailed our evaluation criteria. Under
section 1865(a)(2) of the Act and our
regulations at § 488.4 (Application and
reapplication procedures for
accreditation organizations), we
conducted a review of the AOA
application in accordance with the
criteria specified by our regulation,
which include, but are not limited to the
following:
• An onsite administrative review of
AOA’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 accredited facilities;
and (5) survey review and decisionmaking process for accreditation;
• A comparison of AOA’s ASC
accreditation standards to our current
Medicare ASC conditions for coverage;
and
• A documentation review of AOA’s
survey processes to:
Æ Determine the composition of the
survey team, surveyor qualifications,
and the ability of AOA to provide
continuing surveyor training;
Æ Compare AOA’s processes to those
of State survey agencies, including
survey frequency, and the ability to
investigate and respond appropriately to
complaints against accredited facilities;
Æ Evaluate AOA’s procedures for
monitoring providers or suppliers found
to be out of compliance with AOA’s
program requirements. The monitoring
procedures are used only when AOA
identifies noncompliance. If
noncompliance is identified through
validation reviews, the State survey
agency monitors corrections as specified
at § 488.7(d);
Æ Assess AOA’s ability to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner;
Æ Establish AOA’s ability to provide
us with electronic data and reports
necessary for effective validation and
assessment of AOA’s survey process;
Æ Determine the adequacy of staff and
other resources;
Æ Review AOA’s ability to provide
adequate funding for performing
required surveys;
Æ Confirm AOA’s policies with
respect to whether surveys are
announced or unannounced; and
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Frm 00075
Fmt 4703
Sfmt 4703
48975
Æ Obtain AOA’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 May 26,
2009 proposed notice (74 FR 24857) also
solicited public comments regarding
whether AOA’s requirements met or
exceeded the Medicare conditions for
coverage (CfC) for ASCs. We received no
public comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AOA’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the AOA’s ASCs
accreditation requirements and survey
process with the Medicare CfCs and
survey process as outlined in the State
Operations Manual (SOM). Our review
and evaluation of the AOA’s deeming
application, which were conducted as
described in section III of this final
notice, yielded the following:
• AOA modified its policies related to
the accreditation effective date in
accordance with the requirements at
§ 489.13;
• AOA modified its policies regarding
timeframes for sending and receiving a
plan of correction (PoC) in accordance
with section 2728 of the SOM;
• AOA revised its policies to include
timeframes for investigation of
complaints in accordance with the
requirements at section 5075.9 of the
SOM;
• AOA developed and implemented
internal monitoring procedures to
ensure its surveyors are trained and
qualified to meet the requirements at
§ 488.4(a)(4);
• AOA developed an action plan to
ensure that deemed status survey files
are complete, accurate, and consistent
with the requirements at § 488.6(a);
• AOA developed and conducted
surveyor training on the documentation
of deficiencies to ensure that all cited
deficiencies contain a regulatory
reference, a clear and detailed
description of the deficient practice, and
relevant finding;
• AOA developed a policy to ensure
that facilities with condition level noncompliance on a recertification survey
submit an acceptable PoC, and receive
a follow-up onsite focused survey, in
order to meet the requirements at
§ 488.20(b) and § 488.28(a);
• AOA revised its policies and
developed an internal tracking tool to
E:\FR\FM\25SEN1.SGM
25SEN1
48976
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
ensure that facilities with condition
level non-compliance on an initial
survey receive an onsite follow-up full
survey, in order to meet the
requirements at section 2005A2 of the
SOM;
• AOA developed and incorporated
measures to improve the accuracy and
consistency of data submissions to CMS
in order to meet the requirements at
§ 488.4(b);
• AOA revised its policies on
blackout dates to meet the requirements
at 2700A of the SOM;
• AOA revised its accreditation
decision letters to ensure that they are
accurate and contain all the required
elements for our Regional Office to
render a decision regarding the deemed
status of an accredited ASC;
• AOA revised and updated its
surveyor team handbook to include
references to its ASC deeming program;
• AOA extended its onsite survey
time allotted for review of the CfCs from
1 day to 2 days in order to meet the
requirements at § 488.26; and
• AOA removed all references to
mandatory consultative services from its
policies to avoid potential conflict of
interest issue.
To verify AOA’s continued
compliance with the provisions of this
final notice, we will conduct a followup corporate onsite visit within 1 year
of the date of publication of this notice.
B. Term of Approval
Based on the review and observations
described in section III of this final
notice, we have determined that the
AOA’s requirements for ASCs meet or
exceed our requirements. Therefore, we
approve AOA as a national accreditation
organization for ASCs that request
participation in the Medicare program,
effective October 23, 2009 through
October 23, 2013.
V. Collection of Information
Requirements
jlentini on DSKJ8SOYB1PROD with NOTICES
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).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
Dated: September 10, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E9–22956 Filed 9–24–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4141–N]
A. Medicare Part A and Part B Appeals
Medicare Program; Medicare Appeals;
Adjustment to the Amount in
Controversy Threshold Amounts for
Calendar Year 2010
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice announces the
annual adjustment in the amount in
controversy (AIC) threshold amounts for
Administrative Law Judge (ALJ)
hearings and judicial review under the
Medicare appeals process. The
adjustment to the AIC threshold
amounts will be effective for requests
for ALJ hearings and judicial review
filed on or after January 1, 2010. The
2010 AIC threshold amounts are $130
for ALJ hearings and $1,260 for judicial
review.
DATES: Effective Date: This notice is
effective on January 1, 2010.
FOR FURTHER INFORMATION CONTACT: Liz
Hosna, (410) 786–4993.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1869(b)(1)(E) of the Social
Security Act (the Act), as amended by
section 521 of the Medicare, Medicaid,
and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA),
established AIC threshold amounts for
ALJ hearing requests and judicial review
at $100 and $1000, respectively, for
Medicare Part A and Part B appeals.
Section 940 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003, amended
section 1869(b)(1)(E) of the Act to
require the AIC threshold amounts for
ALJ hearings and judicial review to be
adjusted annually. The AIC threshold
amounts are to be adjusted, as of
January 2005, by the percentage increase
in the medical care component of the
consumer price index for all urban
consumers (U.S. city average) for July
2003 to July of the year preceding the
year involved and rounded to the
nearest multiple of $10. Section
PO 00000
Frm 00076
Fmt 4703
940(b)(2) of the MMA provided
conforming amendments to apply the
AIC adjustment requirement to
Medicare Part C (Medicare Advantage
‘‘MA’’) appeals and certain health
maintenance organization and
competitive health plan appeals. Health
care prepayment plans are also subject
to MA appeals rules, including the AIC
adjustment requirement. Section 101 of
the MMA provides for the application of
the AIC adjustment requirement to
Medicare Part D appeals.
Sfmt 4703
The statutory formula for the annual
adjustment to the AIC threshold
amounts for ALJ hearings and judicial
review of Medicare Part A and Part B
appeals, set forth at section
1869(b)(1)(E) of the Act, is included in
the applicable implementing
regulations, 42 CFR part 405, subpart I,
at § 405.1006(b). The regulations require
the Secretary of the Department of
Health and Human Services (the
Secretary) to publish changes to the AIC
threshold amounts in the Federal
Register (§ 405.1006(b)(2)). In order to
be entitled to a hearing before an ALJ,
a party to a proceeding must meet the
AIC requirements at § 405.1006(b).
Similarly, a party must meet the AIC
requirements at § 405.1006(c) at the time
judicial review is requested for the court
to have jurisdiction over the appeal
(§ 405.1136(a)).
B. Medicare Part C (Medicare
Advantage) Appeals
Section 940(b)(2) of the MMA applies
the AIC adjustment requirement to Part
C (MA) appeals by amending section
1852(g)(5) of the Act. The implementing
regulations for Medicare Part C appeals
are found at 42 CFR part 422, subpart
M. Specifically, § 422.600 and § 422.612
discuss the AIC threshold amounts for
ALJ hearings and judicial review.
Section 422.600 grants any party to
the reconsideration, except the MA
organization, who is dissatisfied with
the reconsideration determination, a
right to an ALJ hearing as long as the
amount remaining in controversy after
reconsideration meets the threshold
requirement established annually by the
Secretary. Section 422.612 states that
any party, including the MA
organization, may request judicial
review if, in part, the amount in
controversy meets the threshold
requirement established annually by the
Secretary.
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 74, Number 185 (Friday, September 25, 2009)]
[Notices]
[Pages 48974-48976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22956]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2487-FN]
Medicare and Medicaid Programs; Application by the American
Osteopathic Association for Continued Deeming Authority for Ambulatory
Surgical Centers
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
American Osteopathic Association (AOA) for continued recognition as a
national accreditation program for ambulatory surgical centers (ASCs)
seeking to participate in the Medicare or Medicaid programs.
DATES: Effective Date: This final notice is effective on October 23,
2009 through October 23, 2013.
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 an ambulatory surgical center (ASC) provided
certain requirements are met. Sections 1832(a)(2)(F)(i) of the Social
Security Act (the Act) establishes distinct criteria for facilities
seeking designation as an ASC. Under this authority, the minimum
requirements that an ASC must meet to participate in Medicare are set
forth in regulations at 42 CFR part 416, which determine the basis and
scope of ASC covered services, and the conditions for Medicare payment
for facility services. Regulations concerning provider agreements are
at 42 CFR part 489 and those pertaining to activities
[[Page 48975]]
relating to the survey and certification of facilities are at 42 CFR
part 488.
Generally, to enter into an agreement, an ASC must first be
certified by a State survey agency as complying with conditions or
requirements set forth in part 416 of our regulations. Then, the ASC is
subject to regular surveys by a State survey agency to determine
whether it continues to meet those 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 that all applicable Medicare conditions are
met or exceeded, we may ``deem'' those provider entities as having met
the requirements. Accreditation by an accreditation organization is
voluntary and is not required for Medicare participation.
If an accreditation organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, a provider entity accredited by the national accrediting
body's approved program may be deemed to meet the Medicare conditions.
A national accreditation organization applying for approval of deeming
authority under part 488, subpart A, must provide us with reasonable
assurance that the accreditation organization requires the accredited
provider entities to meet requirements that are at least as stringent
as the Medicare conditions. Our regulations concerning re-approval of
accrediting organizations are set forth at Sec. 488.4 and Sec.
488.8(d)(3). The regulations at Sec. 488.8(d)(3) require accreditation
organizations to reapply for continued approval of deeming authority
every 6 years, or sooner as we determine.
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 that a 30-day public
comment period. At the end of the 210-day period, we must publish an
approval or denial of the application.
III. Provisions of the Proposed Notice
On May 26, 2009, we published a proposed notice (74 FR 24857)
announcing the American Osteopathic Association's (AOA) request for re-
approval as a deeming organization for ASCs. In the proposed notice, we
detailed our evaluation criteria. Under section 1865(a)(2) of the Act
and our regulations at Sec. 488.4 (Application and reapplication
procedures for accreditation organizations), we conducted a review of
the AOA application in accordance with the criteria specified by our
regulation, which include, but are not limited to the following:
An onsite administrative review of AOA'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 accredited facilities; and (5)
survey review and decision-making process for accreditation;
A comparison of AOA's ASC accreditation standards to our
current Medicare ASC conditions for coverage; and
A documentation review of AOA's survey processes to:
[cir] Determine the composition of the survey team, surveyor
qualifications, and the ability of AOA to provide continuing surveyor
training;
[cir] Compare AOA's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities;
[cir] Evaluate AOA's procedures for monitoring providers or
suppliers found to be out of compliance with AOA's program
requirements. The monitoring procedures are used only when AOA
identifies noncompliance. If noncompliance is identified through
validation reviews, the State survey agency monitors corrections as
specified at Sec. 488.7(d);
[cir] Assess AOA's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner;
[cir] Establish AOA's ability to provide us with electronic data
and reports necessary for effective validation and assessment of AOA's
survey process;
[cir] Determine the adequacy of staff and other resources;
[cir] Review AOA's ability to provide adequate funding for
performing required surveys;
[cir] Confirm AOA's policies with respect to whether surveys are
announced or unannounced; and
[cir] Obtain AOA'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 May 26,
2009 proposed notice (74 FR 24857) also solicited public comments
regarding whether AOA's requirements met or exceeded the Medicare
conditions for coverage (CfC) for ASCs. We received no public comments
in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AOA's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the AOA's ASCs accreditation requirements and survey
process with the Medicare CfCs and survey process as outlined in the
State Operations Manual (SOM). Our review and evaluation of the AOA's
deeming application, which were conducted as described in section III
of this final notice, yielded the following:
AOA modified its policies related to the accreditation
effective date in accordance with the requirements at Sec. 489.13;
AOA modified its policies regarding timeframes for sending
and receiving a plan of correction (PoC) in accordance with section
2728 of the SOM;
AOA revised its policies to include timeframes for
investigation of complaints in accordance with the requirements at
section 5075.9 of the SOM;
AOA developed and implemented internal monitoring
procedures to ensure its surveyors are trained and qualified to meet
the requirements at Sec. 488.4(a)(4);
AOA developed an action plan to ensure that deemed status
survey files are complete, accurate, and consistent with the
requirements at Sec. 488.6(a);
AOA developed and conducted surveyor training on the
documentation of deficiencies to ensure that all cited deficiencies
contain a regulatory reference, a clear and detailed description of the
deficient practice, and relevant finding;
AOA developed a policy to ensure that facilities with
condition level non-compliance on a recertification survey submit an
acceptable PoC, and receive a follow-up onsite focused survey, in order
to meet the requirements at Sec. 488.20(b) and Sec. 488.28(a);
AOA revised its policies and developed an internal
tracking tool to
[[Page 48976]]
ensure that facilities with condition level non-compliance on an
initial survey receive an onsite follow-up full survey, in order to
meet the requirements at section 2005A2 of the SOM;
AOA developed and incorporated measures to improve the
accuracy and consistency of data submissions to CMS in order to meet
the requirements at Sec. 488.4(b);
AOA revised its policies on blackout dates to meet the
requirements at 2700A of the SOM;
AOA revised its accreditation decision letters to ensure
that they are accurate and contain all the required elements for our
Regional Office to render a decision regarding the deemed status of an
accredited ASC;
AOA revised and updated its surveyor team handbook to
include references to its ASC deeming program;
AOA extended its onsite survey time allotted for review of
the CfCs from 1 day to 2 days in order to meet the requirements at
Sec. 488.26; and
AOA removed all references to mandatory consultative
services from its policies to avoid potential conflict of interest
issue.
To verify AOA's continued compliance with the provisions of this
final notice, we will conduct a follow-up corporate onsite visit within
1 year of the date of publication of this notice.
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that the AOA's requirements for
ASCs meet or exceed our requirements. Therefore, we approve AOA as a
national accreditation organization for ASCs that request participation
in the Medicare program, effective October 23, 2009 through October 23,
2013.
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).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: September 10, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-22956 Filed 9-24-09; 8:45 am]
BILLING CODE 4120-01-P
