Medicare and Medicaid Programs; Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) Application for Continuing CMS-Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program, 59616-59618 [2012-23996]
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59616
Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10161]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection.
Title of Information Collection: New
Freedom Initiative—Web-based
Reporting System for Grantees. Use:
CMS awards competitive grants to states
and other eligible entities for the
purpose of designing and implementing
effective and enduring improvements in
community-based long-term services
and support systems. CMS requires that
grantees report on a quarterly, semiannual, and/or annual basis depending
upon the grant type. CMS requires the
information obtained through webbased grantee reporting for two reasons:
To effectively monitor the grants and to
report to Congress and other interested
stakeholders the progress and obstacles
experienced by the grantees. The
grantees are the respondents to the webbased reporting system. Form Number:
CMS–10161 (OCN 0938–0979).
Frequency: Annually, semi-annually,
and quarterly. Affected Public: State,
Local or Tribal Governments. Number of
Respondents: 171. Total Annual
Responses: 428. Total Annual Hours:
3,764. (For policy questions regarding
this collection contact Effie George at
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AGENCY:
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410–786–8639. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on October 29, 2012.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
Email: OIRA_submission@omb.eop.gov.
Dated: September 25, 2012.
Martique Jones,
Director, Regulations Development Group,
Division-B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–23899 Filed 9–27–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3264–FN]
Medicare and Medicaid Programs;
Approval of the American Osteopathic
Association/Healthcare Facilities
Accreditation Program (AOA/HFAP)
Application for Continuing CMSApproval of Its Ambulatory Surgical
Center (ASC) Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the American
Osteopathic Healthcare Facilities
Accreditation Program (AOA/HFAP) for
continued recognition as a national
accrediting organization for ambulatory
surgical centers (ASCs) that wish to
participate in the Medicare and/or
Medicaid programs.
DATES: Effective Date: This final notice
is effective October 23, 2013 through
October 23, 2017.
FOR FURTHER INFORMATION CONTACT:
Barbara Easterling (410) 786–0482.
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in an ASC provided certain
health, safety, and other requirements
are met. Section 1832(a)(2)(F)(i) of the
Act permits the Secretary to establish
distinct criteria for facilities seeking
designation as an ASC. The regulations
at 42 CFR part 416 specify the
conditions that an ASC must meet in
order to participate in the Medicare
program, the scope of covered services,
and the conditions for Medicare
payment for ASCs. Regulations
pertaining to activities relating to the
survey and certification of facilities are
at 42 CFR part 488.
Generally, in order to enter into an
agreement, an ASC must first be
certified by a State survey agency as
complying with the conditions or
requirements set forth in Part 416.
Thereafter, the ASC is subject to regular
surveys by a State survey agency to
determine whether it continues to meet
these requirements. There is an
alternative, however, to surveys by State
agencies.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, we will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation. In accordance with the
requirements at 416.26, an ASC may be
deemed to meet conditions for coverage
if it is accredited by a national
accrediting body.
If an accrediting organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national
accrediting organization applying for
approval of its accreditation program
under Part 488 subpart A must provide
us 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 488.4 and 488.8. The regulations at
488.8(d)(3) require accrediting
organizations to reapply for continued
approval of its accreditation program
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
every 6 years or sooner as determined
by CMS.
AOA/HFAP’s current term of
approval for their ASC accreditation
program expires October 23, 2012.
srobinson on DSK4SPTVN1PROD with NOTICES
II. Application Approval Process
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 after receiving
a complete 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. Provisions of the Proposed Notice
On May 25, 2012, we published a
proposed notice in the Federal Register
(77 FR 31361) announcing AOA/HFAP’s
request for continued approval of its
ASC accreditation program. In the
proposed notice, we detailed our
evaluation criteria. Under section
1865(a)(2) of the Act and in our
regulations at 488.4 and 488.8, we
conducted a review of AOA/HFAP’s
application in accordance with the
criteria specified by our regulations,
which include, but are not limited to the
following:
• An onsite administrative review of
AOA/HFAP’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.
• The comparison of AOA/HFAP’s
accreditation to our current Medicare
ASC conditions for coverage.
• A documentation review of AOA/
HFAP’s survey process for the
following:
+ Determine the composition of the
survey team, surveyor qualifications,
and AOA/HFAP’s ability to provide
continuing surveyor training.
+ Compare AOA/HFAP’s processes to
those of State survey agencies, including
survey frequency, and the ability to
investigate and respond appropriately to
complaints against accredited facilities.
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+ Evaluate AOA/HFAP’s procedures
for monitoring ASC’s found to be out of
compliance with AOA/HFAP’s program
requirements. The monitoring
procedures are used only when AOA/
HFAP identifies noncompliance. If
noncompliance is identified through
validation reviews, the State survey
agency monitors corrections as specified
at 488.7(d).
+ Assess AOA/HFAP’s ability to
report deficiencies to the surveyed
facilities and respond to the facility’s
plan of correction in a timely manner.
+ Establish AOA/HFAP’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 staff and
other resources.
+ Confirm AOA/HFAP’s ability to
provide adequate funding for
performing required surveys.
+ Confirm AOA/HFAP’s policies
with respect to whether surveys are
announced or unannounced.
+ Obtain AOA/HFAP’s agreement to
provide CMS with a copy of the most
current accreditation survey together
with any other information related to
the survey as we may require, including
corrective action plans.
In accordance with Section
1865(a)(3)(A) of the Act, the May 25,
2012 proposed notice also solicited
public comments regarding whether
AOA/HFAP’s requirements met or
exceeded the Medicare conditions for
coverage for ASCs. We received one
comment in response to our proposed
notice. The commenter expressed
support for AOA/HFAP’s ASC
accreditation program.
IV. Provisions of the Final Notice
A. Differences Between AOA/HFAP’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared AOA/HFAP’s ASC
requirements and survey process with
the Medicare conditions for certification
and survey process as outlined in the
State Operations Manual (SOM). Our
review and evaluation of AOA/HFAP’s
ASC application, which were conducted
as described in section III of this final
notice, yielded the following:
• To meet the requirements at
416.44(b)(1), AOA/HFAP revised its
standards to include thresholds for new
and existing Life Safety Code (LSC)
requirements. In addition, AOA/HFAP
revised its standards to ensure all
waivers for LSC deficiencies are
reviewed and approved by the CMS
Regional Office.
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59617
• To meet the requirement at
416.44(b)(4), AOA/HFAP revised its
standards to ensure all ASCs are in
compliance with the emergency lighting
requirements.
• To meet the requirement at 416.50,
AOA/HFAP revised its crosswalk to
include the patient rights condition for
coverage requirements.
• To meet the requirements at 488.4,
AOA/HFAP revised its policies to
ensure the survey process requirements
for ASCs is accurate, clear and
complete.
• To meet the requirements at 488.8,
AOA/HFAP modified its policies and
procedures to ensure all complaints are
appropriately triaged, and investigated.
• To meet the requirements at section
2728 of the SOM, AOA/HFAP modified
its policies to ensure all accepted plans
of correction include the citation cited,
the procedure implementing the plan,
and the monitoring procedure.
• To meet the requirements of 2728B,
AOA/HFAP revised its policies to
ensure all plans of correction contain
the procedure for implementing the
plan and the monitoring procedure to
ensure cited deficiencies remain
corrected and in compliance with the
regulatory requirements.
• AOA/HFAP also made extensive
organization-wide changes to their
internal processes in response to an 18
month accreditation program review
that was concluded in July 2012. AOA/
HFAP demonstrated compliance with
our requirements across their
organization and accreditation
programs.
B. Term of Approval
Based on our review and observations
described in section III of this final
notice, we have determined that AOA/
HFAP’s requirements for ASCs meet or
exceed our requirements. Therefore, we
approve AOA/HFAP as a national
accreditation organization for ASCs that
request participation in the Medicare
program, effective October 23, 2013
through October 23, 2017.
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; No. 93.773 Medicare—ASC
Insurance Program; and No. 93.774,
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Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Notices
Medicare—Supplementary Medical
Insurance Program)
Dated: September 25, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–23996 Filed 9–27–12; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4158–N]
Medicare Program; Medicare Appeals;
Adjustment to the Amount in
Controversy Threshold Amounts for
Calendar Year 2013
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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, 2013. The
calendar year 2013 AIC threshold
amounts are $140 for ALJ hearings and
$1,400 for judicial review.
EFFECTIVE DATE: This notice is effective
on January 1, 2013.
FOR FURTHER INFORMATION CONTACT: Liz
Hosna (Katherine.Hosna@cms.hhs.gov),
(410) 786–4993.
SUPPLEMENTARY INFORMATION:
SUMMARY:
srobinson on DSK4SPTVN1PROD with NOTICES
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 the amount in controversy
(AIC) threshold amounts for
Administrative Law Judge (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 (MMA), 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
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Jkt 226001
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
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.
A. Medicare Part A and Part B Appeals
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 405.1006(b) and (c).
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
Medicare Part C (MA) appeals by
amending section 1852(g)(5) of the Act.
The implementing regulations for
Medicare Part C (MA) 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, in
part, that any party, including the MA
organization, may request judicial
review if the AIC meets the threshold
requirement established annually by the
Secretary.
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C. Health Maintenance Organizations,
Competitive Medical Plans, and Health
Care Prepayment Plans
Section 1876(c)(5)(B) of the Act states
that the annual adjustment to the AIC
dollar amounts set forth in section
1869(b)(1)(E) of the Act applies to
certain beneficiary appeals within the
context of health maintenance
organizations and competitive medical
plans. The applicable implementing
regulations for Medicare Part C appeals
are set forth in 42 CFR part 422, subpart
M, and as discussed previously, apply
to these appeals. The Medicare Part C
appeals rules also apply to health care
prepayment plan appeals.
D. Medicare Part D (Prescription Drug
Plan) Appeals
The annually adjusted AIC threshold
amounts for ALJ hearings and judicial
review that apply to Medicare Parts A,
B, and C appeals also apply to Medicare
Part D appeals. Section 101 of the MMA
added section 1860D–4(h)(1) of the Act
regarding Part D appeals. This statutory
provision requires a prescription drug
plan sponsor to meet the requirements
set forth in sections 1852(g)(4) and (g)(5)
of the Act, in a similar manner as MA
organizations. As noted previously, the
annually adjusted AIC threshold
requirement was added to section
1852(g)(5) of the Act by section
940(b)(2)(A) of the MMA. The
implementing regulations for Medicare
Part D appeals can be found at 42 CFR
part 423, subparts M and U. The
regulations at § 423.562(c) prescribe
that, unless the Part D appeals rules
provide otherwise, the Part C appeals
rules (including the annually adjusted
AIC threshold amount) apply to Part D
appeals to the extent they are
appropriate. More specifically,
§ 423.1970 and § 423.1976 of the Part D
appeals rules discuss the AIC threshold
amounts for ALJ hearings and judicial
review. Section 423.1970(a) grants a Part
D enrollee, who is dissatisfied with the
independent review entity (IRE)
reconsideration determination, a right to
an ALJ hearing if the amount remaining
in controversy after the IRE
reconsideration meets the threshold
amount established annually by the
Secretary. Sections 423.1976(a) and (b)
allow a Part D enrollee to request
judicial review of an ALJ or MAC
decision if, in part, the AIC meets the
threshold amount established annually
by the Secretary.
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]]>Agencies
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59616-59618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3264-FN]
Medicare and Medicaid Programs; Approval of the American
Osteopathic Association/Healthcare Facilities Accreditation Program
(AOA/HFAP) Application for Continuing CMS-Approval of Its Ambulatory
Surgical Center (ASC) Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
American Osteopathic Healthcare Facilities Accreditation Program (AOA/
HFAP) for continued recognition as a national accrediting organization
for ambulatory surgical centers (ASCs) that wish to participate in the
Medicare and/or Medicaid programs.
DATES: Effective Date: This final notice is effective October 23, 2013
through October 23, 2017.
FOR FURTHER INFORMATION CONTACT:
Barbara Easterling (410) 786-0482.
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 ASC provided certain health, safety, and other
requirements are met. Section 1832(a)(2)(F)(i) of the Act permits the
Secretary to establish distinct criteria for facilities seeking
designation as an ASC. The regulations at 42 CFR part 416 specify the
conditions that an ASC must meet in order to participate in the
Medicare program, the scope of covered services, and the conditions for
Medicare payment for ASCs. Regulations pertaining to activities
relating to the survey and certification of facilities are at 42 CFR
part 488.
Generally, in order to enter into an agreement, an ASC must first
be certified by a State survey agency as complying with the conditions
or requirements set forth in Part 416. Thereafter, the ASC is subject
to regular surveys by a State survey agency to determine whether it
continues to meet these requirements. There is an alternative, however,
to surveys by State agencies.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by an approved national accrediting
organization that all applicable Medicare conditions are met or
exceeded, we will deem those provider entities as having met the
requirements. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation. In accordance with the
requirements at 416.26, an ASC may be deemed to meet conditions for
coverage if it is accredited by a national accrediting body.
If an accrediting organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, any provider entity accredited by the national
accrediting body's approved program would be deemed to meet the
Medicare conditions. A national accrediting organization applying for
approval of its accreditation program under Part 488 subpart A must
provide us 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
488.4 and 488.8. The regulations at 488.8(d)(3) require accrediting
organizations to reapply for continued approval of its accreditation
program
[[Page 59617]]
every 6 years or sooner as determined by CMS.
AOA/HFAP's current term of approval for their ASC accreditation
program expires October 23, 2012.
II. Application Approval Process
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 after
receiving a complete 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. Provisions of the Proposed Notice
On May 25, 2012, we published a proposed notice in the Federal
Register (77 FR 31361) announcing AOA/HFAP's request for continued
approval of its ASC accreditation program. In the proposed notice, we
detailed our evaluation criteria. Under section 1865(a)(2) of the Act
and in our regulations at 488.4 and 488.8, we conducted a review of
AOA/HFAP's application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
An onsite administrative review of AOA/HFAP'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.
The comparison of AOA/HFAP's accreditation to our current
Medicare ASC conditions for coverage.
A documentation review of AOA/HFAP's survey process for
the following:
+ Determine the composition of the survey team, surveyor
qualifications, and AOA/HFAP's ability to provide continuing surveyor
training.
+ Compare AOA/HFAP's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
+ Evaluate AOA/HFAP's procedures for monitoring ASC's found to be
out of compliance with AOA/HFAP's program requirements. The monitoring
procedures are used only when AOA/HFAP identifies noncompliance. If
noncompliance is identified through validation reviews, the State
survey agency monitors corrections as specified at 488.7(d).
+ Assess AOA/HFAP's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ Establish AOA/HFAP'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 staff and other resources.
+ Confirm AOA/HFAP's ability to provide adequate funding for
performing required surveys.
+ Confirm AOA/HFAP's policies with respect to whether surveys are
announced or unannounced.
+ Obtain AOA/HFAP's agreement to provide CMS with a copy of the
most current accreditation survey together with any other information
related to the survey as we may require, including corrective action
plans.
In accordance with Section 1865(a)(3)(A) of the Act, the May 25,
2012 proposed notice also solicited public comments regarding whether
AOA/HFAP's requirements met or exceeded the Medicare conditions for
coverage for ASCs. We received one comment in response to our proposed
notice. The commenter expressed support for AOA/HFAP's ASC
accreditation program.
IV. Provisions of the Final Notice
A. Differences Between AOA/HFAP's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared AOA/HFAP's ASC requirements and survey process with the
Medicare conditions for certification and survey process as outlined in
the State Operations Manual (SOM). Our review and evaluation of AOA/
HFAP's ASC application, which were conducted as described in section
III of this final notice, yielded the following:
To meet the requirements at 416.44(b)(1), AOA/HFAP revised
its standards to include thresholds for new and existing Life Safety
Code (LSC) requirements. In addition, AOA/HFAP revised its standards to
ensure all waivers for LSC deficiencies are reviewed and approved by
the CMS Regional Office.
To meet the requirement at 416.44(b)(4), AOA/HFAP revised
its standards to ensure all ASCs are in compliance with the emergency
lighting requirements.
To meet the requirement at 416.50, AOA/HFAP revised its
crosswalk to include the patient rights condition for coverage
requirements.
To meet the requirements at 488.4, AOA/HFAP revised its
policies to ensure the survey process requirements for ASCs is
accurate, clear and complete.
To meet the requirements at 488.8, AOA/HFAP modified its
policies and procedures to ensure all complaints are appropriately
triaged, and investigated.
To meet the requirements at section 2728 of the SOM, AOA/
HFAP modified its policies to ensure all accepted plans of correction
include the citation cited, the procedure implementing the plan, and
the monitoring procedure.
To meet the requirements of 2728B, AOA/HFAP revised its
policies to ensure all plans of correction contain the procedure for
implementing the plan and the monitoring procedure to ensure cited
deficiencies remain corrected and in compliance with the regulatory
requirements.
AOA/HFAP also made extensive organization-wide changes to
their internal processes in response to an 18 month accreditation
program review that was concluded in July 2012. AOA/HFAP demonstrated
compliance with our requirements across their organization and
accreditation programs.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we have determined that AOA/HFAP's requirements for
ASCs meet or exceed our requirements. Therefore, we approve AOA/HFAP as
a national accreditation organization for ASCs that request
participation in the Medicare program, effective October 23, 2013
through October 23, 2017.
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; No. 93.773 Medicare--ASC Insurance Program; and
No. 93.774,
[[Page 59618]]
Medicare--Supplementary Medical Insurance Program)
Dated: September 25, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-23996 Filed 9-27-12; 8:45 am]
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