[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67520-67522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27122]


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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

[[Page 67521]]

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.

[[Page 67522]]

     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