[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Pages 17068-17070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2901-FN]


Medicare and Medicaid Programs; Approval of the Application by 
the American Association for Accreditation of Ambulatory Surgery 
Facilities for Deeming Authority for Rural Health Clinics

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
American Association for Accreditation of Ambulatory Surgery Facilities

[[Page 17069]]

(AAAASF) for recognition as a national accreditation program for rural 
health clinics (RHCs) seeking to participate in the Medicare or 
Medicaid programs.

DATES: Effective Date: This final notice is effective March 23, 2012 
through March 23, 2016.

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 a rural health clinic (RHC) provided certain 
requirements are met. Sections 1861(aa) and 1905(l) of the Social 
Security Act (the Act) establish distinct criteria for facilities 
seeking designation as an RHC. The minimum requirements that a RHC must 
meet to participate in Medicare are set forth in regulation at 42 CFR 
part 491, subpart A. The conditions for Medicare payment for RHCs are 
set forth at 42 CFR 405, subpart X. Applicable regulations concerning 
provider agreements are located in 42 CFR part 489 and those pertaining 
to facility survey and certification are in 42 CFR part 488, subpart A.
    For an RHC to enter into a provider agreement with the Medicare 
program, the RHC must first be certified by a State survey agency as 
complying with the conditions or requirements set forth in section 
1861(aa) of the Act and part 491 of our regulations. Subsequently, the 
RHC is subject to ongoing review by a State survey agency to determine 
whether it continues to meet the Medicare conditions for certification. 
There is an alternative, however, to State compliance surveys. 
Certification by a nationally recognized accreditation program can 
substitute for ongoing State review.
    Section 1865(a)(1) of the Act provides that, if an entity 
demonstrates through accreditation by an approved national 
accreditation organization (AO) that all applicable Medicare conditions 
are met or exceeded, we may ``deem'' that entity as having met the 
requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation. A national AO 
applying for approval of its accreditation program under part 488, 
subpart A, must provide us with reasonable assurance that the AO 
requires the accredited entities to meet requirements that are at least 
as stringent as the Medicare conditions.

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 calendar days after the date of receipt of a complete 
application, with any documentation necessary to make a 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 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 a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice

    On October 28, 2011, we published a proposed notice in the Federal 
Register (76 FR 66929) announcing AAAASF's request for approval of its 
RHC accreditation program. In the proposed notice, we detailed our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 and Sec.  488.8, we conducted a review of 
AAAASF's application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following:
    <bullet> 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.
    <bullet> A comparison of AAAASF's RHC accreditation standards to 
our current Medicare RHC conditions for certification.
    <bullet> A documentation review of AAAASF's survey processes to:
    [boxvh] Determine the composition of the survey team, surveyor 
qualifications, and AAAASF's ability to provide continuing surveyor 
training.
    [boxvh] 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.
    [boxvh] 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).
    [boxvh] Assess AAAASF's ability to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    [boxvh] Establish AAAASF's ability to provide us with electronic 
data and reports necessary for effective validation and assessment of 
AAAASF's survey process.
    [boxvh] Determine the adequacy of staff and other resources.
    [boxvh] Review AAAASF's ability to provide adequate funding for 
performing required surveys.
    [boxvh] Confirm AAAASF's policies with respect to whether surveys 
are announced or unannounced.
    [boxvh] 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 October 
28, 2011 proposed notice also solicited public comments regarding 
whether AAAASF's requirements met or exceeded the Medicare conditions 
for certification for RHCs We received no 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 RHC accreditation 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 AAAASF's RHC application, which were conducted as 
described in section III of this final notice, yielded the following:
    <bullet> To meet the requirements at Sec.  491.2, AAAASF revised 
its crosswalk to ensure all RHC definitions contained correct 
regulatory text.
    <bullet> To meet the staffing requirements at Sec.  491.8(a)(2), 
AAAASF revised its standards to ensure the physician member of the RHC 
staff carries out the responsibilities set out at Sec.  491.8(b).
    <bullet> To meet the requirements at Sec.  491.9(a)(3), AAAASF 
revised its standards to ensure the RHC provides the required 
laboratory services.
    <bullet> To meet the requirements at Sec.  488.4, AAAASF revised 
its policies to ensure its surveyors are appropriately qualified and 
trained.

[[Page 17070]]

    <bullet> To meet the requirements at section 2008D of the SOM, 
AAAASF revised its policies related to the accreditation effective 
date.
    <bullet> To meet the requirements at section 2200F of the SOM, 
AAAASF revised its policies to ensure their surveys are complete, 
accurate, and consistent.
    <bullet> To meet the requirements at section 2700A of the SOM, 
AAAASF revised its policies to ensure all RHC surveys are conducted 
unannounced.
    <bullet> To meet the requirements at section 2704 of the SOM, 
AAAASF revised its RHC Accreditation Facility Handbook to include pre-
survey preparation requirements.
    <bullet> To meet the requirements at section 2728 of the SOM, 
AAAASF modified its policies regarding timeframes for sending and 
receiving a plan of correction.
    <bullet> To meet the requirements at section 3010 of the SOM, 
AAAASF revised its policies on immediate jeopardy.
    <bullet> To meet the requirements at chapter five of the SOM, 
AAAASF revised its policies to ensure all complaints are appropriately 
triaged, investigated and resolved.
    <bullet> To meet the requirements at Exhibit 7 of the SOM, AAAASF 
revised its policies to ensure survey deficiencies are cited at the 
appropriate level based on the surveyor documentation.
    <bullet> To verify AAAASF's continued compliance with the 
provisions of this final notice, CMS will conduct a follow-up survey 
observation within 1 year of the date of publication of this notice.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AAAASF's requirements for 
RHCs meet or exceed our requirements. Therefore, we approve AAAASF as a 
national accreditation organization for RHCs that request participation 
in the Medicare program, effective March 23, 2012 through March 23, 
2016.

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: March 8, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-6331 Filed 3-22-12; 8:45 am]
BILLING CODE 4120-01-P