[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]
[Page 67520-67522]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2897-FN]
Medicare and Medicaid Programs; Approval of the Accreditation
Association for Ambulatory Health Care for Continued Deeming Authority
for Ambulatory Surgical Centers
AGENCY: Centers for Medicare & Medicaid Services, (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care (AAAHC) 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 December 20, 2008
through December 20, 2012.
FOR FURTHER INFORMATION CONTACT: Aviva Walker-Sicard, (410)-786-8648.
Patricia Chmielewski (410)-786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
selected covered services in an ASC provided certain requirements are
met. Sections 1832(a)(2)(f)(i) of the Social Security Act (the Act)
authorizes the Secretary to establish 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 determines the basis and
scope of ASC covered services, and the conditions for
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Medicare payment for facility services. Regulations concerning provider
agreements are at 42 CFR part 489 and those pertaining to activities
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 (as redesignated under section 125(b)
of the Medicare Improvements for Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110-275)) 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 Medicare requirements. (We note that section 125 of MIPPA
redesignated subsections (b) through (e) of section 1865 of the Act as
(a) through (d), respectively.) 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 reapproval 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. The AAAHC's current term of
approval as a recognized accreditation program for ASCs expires
December 20, 2008.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act (formerly section 1865(b)(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 an approval or denial of the
application.
III. Provisions of the Proposed Notice
In the June 27, 2008 Federal Register (73 FR 36520), we published a
proposed notice announcing the AAAHC's 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 (formerly
section 1865(b)(2) of the Act) and our regulations at Sec. 488.4
(Application and reapplication procedures for accreditation
organizations), we conducted a review of the AAAHC application in
accordance with the criteria specified by our regulation, which
include, but are not limited to the following:
An onsite administrative review of AAAHC'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 AAAHC's ASC accreditation standards to our
current Medicare ASC conditions for coverage.
A documentation review of AAAHC's survey processes to--
++ Determine the composition of the survey team, survey or
qualifications, and the ability of AAAHC to provide continuing surveyor
training;
++ Compare AAAHC'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 AAAHC's procedures for monitoring providers or
suppliers found to be out of compliance with AAAHC program
requirements. The monitoring procedures are used only when AAAHC
identifies noncompliance. If noncompliance is identified through
validation reviews, the State survey agency monitors corrections as
specified at Sec. 488.7(d);
++ Assess AAAHC's ability to report deficiencies to a surveyed
facility and respond to the facility's plan of correction in a timely
manner;
++ Establish AAAHC's ability to provide us with electronic data and
reports necessary for effective validation and assessment of AAAHC's
survey process;
++ Determine the adequacy of staff and other resources;
++ Review AAAHC's ability to provide adequate funding for
performing required surveys;
++ Confirm AAAHC's policies with respect to whether surveys are
announced or unannounced; and,
++ Obtain AAAHC'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 (formerly
1865(b)(3)(A) of the Act), the June 27, 2008 proposed notice, also
solicited public comments regarding whether AAAHC's requirements met or
exceeded the Medicare conditions of coverage for ASCs. We received no
public comments in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the AAAHC's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards contained in AAAHC's accreditation
requirements for ASCs and its survey process in AAAHC's application for
renewal of deeming authority for ASCs with the Medicare ASC conditions
for coverage and our State Operations Manual (SOM). Our review and
evaluation of AAAHC's deeming application, which were conducted as
described in section III. of this final notice, yielded the following:
To meet the requirements at Sec. 416.41, AAAHC added
language to its standards to ensure that the governing body will
provide contracted services in a safe and effective manner.
To meet the requirements at Sec. 416.42, AAAHC modified
its standards to require surgical procedures be performed only by
qualified physicians in a safe manner.
AAAHC modified its standards to ensure the administration
of anesthesia meets the requirements at Sec. 416.42.
To meet the requirements at Sec. 416.44(a)(3), AAAHC
amended its standards to ensure that ASC's establish programs for
identifying and preventing infections, maintain sanitary environments,
and report the results to appropriate authorities.
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To meet the requirements at Sec. 416.44, AAAHC updated
the requirements on its Physical Environment Checklist (PEC) and
modified its policies to clearly reflect that life safety code (LSC)
waivers may only be granted by a CMS regional office.
To meet the requirements at Sec. 416.44(d), AAAHC revised
its standards to require that ASCs train personnel in the use of all
types of emergency equipment, not just cardiopulmonary and cardiac
emergency equipment.
To meet the requirements at Sec. 416.45(b), AAAHC revised
its standards to require that the scope of procedures performed in the
ASC be periodically reviewed and amended as appropriate.
To meet the requirements at Sec. 416.46(a), AAAHC revised
its standards to require a registered nurse be available for emergency
treatment whenever there is a patient in the ASC.
To meet the requirements at Sec. 416.47(b), AAAHC revised
its survey procedures to ensure that surveyors use a random selection
of medical records for review during an onsite survey.
To meet the requirements at Sec. 488.4(a)(4), AAAHC
revised its policies related to surveyor credentialing and privileging
to ensure that surveyor's were appropriately privileged, credentialed
and trained.
AAAHC modified its surveyor training program to strengthen
the Physical Environment and Life Safety Code training to ensure that
surveyors thoroughly understand Physical Environment and Life Safety
Code and can translate the teachings into practice on survey.
CMS will conduct a survey observation, in 1 year, to
validate the implementation of AAAHC's revised surveyor training
program for Physical Environment and Life Safety Code and assess the
competency of the surveyor's ability to conduct Physical Environment
and Life Safety Code surveys in accordance with Medicare requirements.
AAAHC amended its policies and procedures to address any
real or perceived conflict of interest issues between AAAHC's
accreditation activities and AAAHC's consultative services.
To meet the requirements at Sec. 488.4(a)(6) AAAHC
amended its policies and procedures for complaints to comply with the
Medicare requirements in Chapter 5 of the SOM.
AAAHC revised its accreditation decision letters to ensure
they are accurate and contain all of the required elements necessary
for the CMS Regional Office to render a decision regarding deemed
status of a provider.
AAAHC modified its policies regarding condition-level
noncompliance identified during an initial certification survey for
participation in Medicare in accordance with section 2005A of the SOM.
To meet the Medicare requirements at Sec. 488.20(a) and
Sec. 488.28(a), AAAHC developed a policy regarding CMS requirements
for submission of a plan of correction by the ASC and the completion of
an onsite follow-up survey to determine compliance with the Medicare
conditions for coverage (CFCs) after citing condition level
noncompliance during a recertification survey.
AAAHC modified its policies regarding timeframes for
sending and receiving a required plan of correction in accordance with
section 2728 of the SOM.
To meet the Medicare requirements related to unannounced
surveys at 2700A of the SOM, AAAHC expanded its survey window in which
organizations could receive an accreditation survey for deemed status.
AAAHC modified the language related to deferred decisions
and early survey option in its accreditation handbook to provide
clarification and consistency between its policies and the Medicare
requirements.
AAAHC amended its policies regarding subsequent revisions
of its Accreditation Handbook and surveyor tools to ensure all
documents are consistent in language and reflect CMS's requested
changes.
B. Term of Approval
Based on the review and observations described in section III. of
this final notice, we have determined that AAAHC's requirements for
ASCs meet or exceed our requirements. Therefore, we approve AAAHC as a
national accreditation organization for ASCs that request participation
in the Medicare program, effective December 20, 2008 through December
20, 2012.
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. Chapter 35).
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance Program; and Catalog of Federal
Domestic Assistance Program No. 93.778, Medical Assistance Program)
Dated: October 2, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-27122 Filed 11-13-08; 8:45 am]
BILLING CODE 4120-01-P