[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62330-62333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2476-FN]


Medicare and Medicaid Programs; Conditional Approval of 
Application by the American Association for Accreditation of Ambulatory 
Surgery Facilities 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 final notice announces our decision to conditionally 
approve, with a 180 day probationary period, the American Association 
for Accreditation of Ambulatory Surgery Facilities (AAAASF) for 
continued recognition as a national accreditation program for 
ambulatory surgical centers seeking to participate in the Medicare or 
Medicaid programs.

DATES: Effective Date: This final notice is effective on November 27, 
2009 through November 27, 2012, with a 180-day probationary period 
beginning November 27, 2009 through May 26, 2010.

FOR FURTHER INFORMATION CONTACT: Lillian Williams (410) 786-8636. 
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. Section 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 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

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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 
section 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 American Association for Accreditation of Ambulatory 
Surgery Facilities (AAAASF) term of approval as a recognized 
accreditation program for ASCs expires November 26, 2009.

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 an 
approval or denial of the application.

III. Provisions of the Proposed Notice

    On June 26, 2009, we published a proposed notice (74 FR 30587) 
announcing AAAASF's 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 AAAASF application in 
accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
     An onsite administrative review of AAAASF'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 AAAASF's ASC accreditation standards to 
our current Medicare ASC conditions for coverage (CfC); and,
     A documentation review of AAAASF's survey processes to--
    o Determine the composition of the survey team, surveyor 
qualifications, and the ability of AAAASF to provide continuing 
surveyor training;
    [cir] Compare AAAASF'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 AAAASF's procedures for monitoring providers or 
suppliers found to be out of compliance with AAAASF's program 
requirements. The monitoring procedures are used only when AAAASF 
identifies noncompliance. If noncompliance is identified through 
validation reviews, the State survey agency monitors corrections as 
specified at Sec.  488.7(d);
    [cir] Assess AAAASF's ability to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner;
    [cir] Establish AAAASF's ability to provide us with electronic data 
and reports necessary for effective validation and assessment of 
AAAASF's survey process;
    [cir] Determine the adequacy of staff and other resources;
    [cir] Review AAAASF's ability to provide adequate funding for 
performing required surveys;
    [cir] Confirm AAAASF's policies with respect to whether surveys are 
announced or unannounced; and,
    [cir] Obtain AAAASF'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 June 26, 
2009 proposed notice (74 FR 30587) also solicited public comments 
regarding whether AAAASF's requirements met or exceeded the Medicare 
CfCs for ASCs. We received no public comments in response to our 
proposed notice.

IV. Provisions of the Final Notice

A. Differences Between AAAASF's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared AAAASF's 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 AAAASF's 
deeming application, which were conducted as described in section III 
of this final notice, yielded the following:
     To meet the requirements at Sec.  416.2, AAAASF revised 
their standards to include the current definition of an ASC.
     To meet the requirements at Sec.  416.41(a), AAAASF 
revised their standards to ensure contracted services of an ASC are 
provided in a safe and effective manner.
     To meet the requirements at Sec.  416.41(b)(2) and 
416.41(b)(3), AAAASF revised their standards to ensure that an ASC has 
a transfer agreement with a local Medicare participating hospital and a 
procedure for transferring patients with emergency needs to a Medicare 
hospital, or a non-participating hospital that meets the requirements 
for payment at Sec.  482.2.
     To meet the requirements at Sec.  416.41(c)(1), AAAASF 
revised their standards to ensure ASCs maintain a written disaster 
preparedness plan.
     To meet the requirements at Sec.  416.42, AAAASF revised 
their standards to ensure surgical procedures provided in the ASC are 
performed in a safe manner.
     To meet the requirements at Sec.  416.42(a)(1), AAAASF 
revised their standards to require a physician examine a patient to 
evaluate the risk of anesthesia and the procedure to be performed 
immediately before surgery.
     To meet the requirements at Sec.  416.44(a), AAAASF 
revised their standards to include the requirement that ASCs provide a 
functional and sanitary environment for the provision of surgical 
services.
     To meet the requirements at Sec.  416.44(b)(5)(iii), 
AAAASF revised their standards to require alcohol-based hand rub 
dispensers be installed in a manner that adequately protects against 
inappropriate access.
     To meet the requirements at Sec.  416.44(c), AAAASF 
revised their standards to ensure that ASCs that utilize an automated 
external defibrillator (AED) have policies and procedures to indicate 
an AED is sufficient given the patient population and types of 
procedures performed. In addition, AAAASF revised their standards to 
include the requirement that emergency medical equipment and supplies 
be available in the operating room.
     To meet the requirements at Sec.  416.46, AAAASF revised 
their standards to ensure the nursing services of the ASC are directed 
and staffed to meet all of the patient's nursing needs.
     To meet the requirements at Sec.  416.47 (b), AAAASF 
revised their standards to include the requirement that every medical 
record must be accurate and promptly completed.

[[Page 62332]]

     To meet the requirements at Sec.  416.47(b)(2), AAAASF 
revised their standards to require medical records include a 
significant medical history and results of physical examination.
     To meet the requirements at Sec.  416.49, AAAASF revised 
their standards to require ASCs that do not provide laboratory services 
to have procedures for obtaining laboratory services.
     To meet the requirements at Sec.  416.49(b)(1), AAAASF 
revised their standards to include the requirement that ASCs have 
procedures for obtaining radiologic services.
     To meet the requirements at Sec.  416.49(b)(2), AAAASF 
revised their standards to ensure that radiologic services provided in 
an ASC meet the hospital conditions of participation for radiologic 
services specified at Sec.  482.26.
     To meet the requirements at Sec.  416.50, AAAASF revised 
their standards to include the requirement that an ASC must inform the 
patient of his or her rights.
     To meet the requirements at Sec.  416.50(b) through Sec.  
416.50(d) AAAASF revised their standards to include patient rights 
requirements.
     To meet the requirements at Sec.  416.51(a), AAAASF 
revised their standards to include the requirement that ASCs provide a 
functional and sanitary environment for the provision of surgical 
services by adhering to professionally acceptable standards of 
practice.
     To meet the requirements at Sec.  416.51(b), AAAASF 
revised their standards to ensure ASCs maintain an infection control 
and prevention program.
     To meet the requirements at Sec.  416.52, AAAASF revised 
their standards to include the requirements that the ASC must ensure 
each patient has the appropriate pre- and post-surgical assessments 
completed and that all elements of the discharge requirements are 
completed.
     To meet the requirements at Sec.  488.4(a)(4), AAAASF 
developed and implemented internal monitoring procedures to ensure 
their surveyors are trained and qualified.
     To eliminate any real or perceived conflict of interest 
between AAAASF's accreditation activities and the financial, consulting 
and professional activities of AAAASF's surveyors, AAAASF developed and 
implemented policies and procedures that adequately address conflicts 
of interest issues for surveyors.
     To meet the requirements at Sec.  488.6(a), AAAASF 
developed an action plan to ensure that deemed status survey files are 
complete, accurate, and consistent.
     To meet the requirements at SOM 2200F, AAAASF revised its 
survey report to ensure the documentation of cited deficiencies 
contains a regulatory reference, a clear and detailed description of 
the deficient practice, and relevant findings.
     To meet the requirements at Sec.  488.20(b) and Sec.  
488.28(a), AAAASF developed a policy to ensure that facilities with 
condition level non-compliance on a recertification survey submit an 
acceptable plan of correction (PoC) and receive a follow-up onsite 
focused survey.
     To meet the requirements at Sec.  489.13, AAAASF modified 
its policies related to the accreditation effective date for new 
providers.
     AAAASF develop a policy regarding condition level 
noncompliance identified during an initial certification survey for 
participation in Medicare in accordance with section 2005A2 of the SOM.
     To meet the requirements at 2728 of the SOM, AAAASF 
modified its policies regarding timeframes for sending and receiving a 
PoC.
     To meet our requirements related to a PoC, AAAASF amended 
its policies to ensure approved PoCs contain all elements specified in 
section 2728 of the SOM.
     To meet the requirements at 2700A of the SOM, AAAASF 
developed and implemented new policies and procedures that ensure all 
surveys are unannounced.
     AAAASF revised its policies to ensure timeframes for 
investigation of complaints are consistent with the requirements at 
section 5075.9 of the SOM.
     AAAASF revised its accreditation decision letters to 
ensure that they are accurate and contain all the required elements for 
the CMS Regional Office to render a decision regarding the deemed 
status of an accredited ASC.
     To meet the requirements at Sec.  488.20(b)(1), AAAASF 
revised its policies to allow resurveys of a provider as frequently as 
necessary to ascertain compliance and confirm correction of 
deficiencies.
     AAAASF revised its policies to require that all 
deficiencies identified during a deemed survey visit be cited and 
documented, including deficiencies corrected onsite at the time of 
survey.
     To ensure AAAASF surveyors are properly trained and can 
effectively apply knowledge and skills acquired in training, AAAASF 
expanded its surveyor training program to include a Medicare surveyor 
handbook, comprehensive interpretive guidelines, random validation 
surveys to assess surveyor performance, and an onsite preceptor 
training and evaluation program.
    To verify AAAASF's continued compliance with the provisions of this 
final notice, we will conduct a follow-up corporate onsite visit and 
survey observation within 6 months of the date of publication of this 
notice.
    Review of AAAASF's renewal application for ASCs deeming authority 
revealed that AAAASF has ongoing, serious, widespread areas of non-
compliance, specifically AAAASF's--
     Inability to provide us with accurate and timely data on 
deemed providers;
     Lack of complete and accurate deemed facility survey 
files; and
     Inadequate surveyor training and evaluation program.
    Due to the significant number of areas of noncompliance identified 
during the review of AAAASF's renewal application for ASCs deeming 
authority, we have concerns that AAAASF's accreditation program for 
ASCs may no longer provide reasonable assurance that its accredited 
entities meet the Medicare requirements.
    In accordance with Sec.  488.8(d)(3), every 6 years, or sooner as 
determined by us, an approved accreditation organization must reapply 
for continued approval of deeming authority. We notify the organization 
of the materials they must submit as part of the reapplication 
procedure. An accreditation organization that is not meeting the 
requirements of this subpart, as determined through a comparability 
review, must furnish us, upon request and at any time, with the 
reapplication materials upon request. We will establish a deadline by 
which the materials are to be submitted.
    In accordance with Sec.  488.8(f)(3)(i), if we determine that an 
accreditation organization has failed to adopt requirements comparable 
to our requirements, we may grant a conditional approval of the 
accreditation organization's deeming authority for a period of up to 1 
year to adopt comparable requirements; in this case, we are providing 
AAAASF with a probationary period of 180 days. Within 60 days after the 
end of AAAASF's probationary period, we will make a final determination 
as to whether or not AAAASF's ASCs accreditation requirements are 
comparable to our requirements and issue an appropriate notice that 
includes reasons for our determination, no later than August 23, 2010. 
If AAAASF has not made improvements acceptable to us during

[[Page 62333]]

the 180-day probationary period, we may remove recognition of deemed 
authority for its ASC program effective 30 days after the date we 
provide written notice to AAAASF that its ASC deeming authority will be 
removed.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that AAAASF's accreditation 
program for ASCs requires further revision and subsequent review. We 
are confident that with additional time, AAAASF will make the necessary 
revisions to ensure AAAASF's accreditation program for ASCs meets or 
exceeds the Medicare requirements as stated at 42 CFR part 416. 
Therefore, we conditionally approve AAAASF as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective November 27, 2009 through November 27, 2012, with a 
180-day probationary period beginning November 27, 2009 through May 26, 
2010.

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: October 29, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-28048 Filed 11-25-09; 8:45 am]
BILLING CODE 4120-01-P