[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9481-9482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3322-FN]


Medicare and Medicaid Programs: Continued Approval of the 
American Association for Accreditation of Ambulatory Surgery Facilities 
Rural Health Clinic Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, 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 
(AAAASF) for continued recognition as a national accrediting 
organization for Rural Health Clinics (RHCs) that wish to participate 
in the Medicare or Medicaid programs.

DATES: This final notice is effective March 23, 2016 through March 23, 
2022.

FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-3410, or 
Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    A healthcare provider may enter into an agreement with Medicare to 
participate in the program as a Rural Health Clinic (RHC) provided 
certain requirements are met. Sections 1861(aa)(1) and 1905(l)(1) of 
the Social Security Act (the Act), establish distinct criteria for 
facilities seeking designation as a RHC. Regulations concerning 
Medicare provider agreements are at 42 CFR part 489 and those 
pertaining to the survey and certification for Medicare participation 
of providers and certain types of suppliers are at 42 CFR part 488. The 
regulations at 42 CFR part 491, subpart A specify the conditions that a 
provider must meet to participate in the Medicare program as a RHC.
    Generally, to enter into a Medicare provider agreement, a facility 
must first be certified by a state survey agency as complying with the 
conditions or requirements set forth in part 491, subpart A, of our 
Medicare regulations. Thereafter, the RHC is subject to periodic 
surveys by a state survey agency to determine whether it continues to 
meet these conditions. However; there is an alternative to 
certification surveys by state agencies. Accreditation by a nationally 
recognized Medicare accreditation program approved by the Centers for 
Medicare & Medicaid Services (CMS) may substitute for both initial and 
ongoing state review.

[[Page 9482]]

    Section 1865(a)(1) of the Act provides that, if the Secretary of 
the Department of Health and Human Services (the Secretary) finds that 
accreditation of a provider entity by an approved national 
accreditation organization meets or exceeds all applicable Medicare 
conditions or requirements, we may ``deem'' the provider entity to be 
in compliance. Accreditation by an accrediting organization is 
voluntary and is not required for Medicare participation.
    Part 488, subpart A implements the provisions of section 1865 of 
the Act. It requires that a national accrediting organization applying 
for approval of its Medicare accreditation program must provide CMS 
with reasonable assurance that the accrediting organization requires 
its accredited provider or supplier 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 
Sec.  488.5. The regulations at Sec.  488.5(e)(2)(i) require an 
accrediting organization to reapply for continued approval of its 
Medicare accreditation program every 6 years or sooner as determined by 
CMS. The American Association for Accreditation of Ambulatory Surgery 
Facilities (AAAASF's) current term of approval for their RHC 
accreditation program expires March 23, 2016.

II. Application Approval Process

    Section 1865(a)(3)(A) of the Act requires that we publish, within 
60 days of receipt of an organization's complete application, a notice 
identifying the national accreditation body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days after the date of receipt of a 
complete application to publish a notice announcing our approval or 
denial of an application.

III. Provisions of the Proposed Notice

    On September 25, 2015, we published a proposed notice in the 
Federal Register (80 FR 57822) entitled, ``Application from the 
American Association for Accreditation of Ambulatory Surgery Facilities 
for Continued Approval of its Rural Health Accreditation Program.'' In 
that notice, we detailed our evaluation criteria. Under section 
1865(a)(2) of the Act and in our regulations at Sec.  488.5, we 
conducted a review of AAAASF's Medicare RHC accreditation 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 
evaluating its RHC surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited RHCs; and, (5) survey 
review and decision-making process for accreditation.
     The comparison of AAAASF's Medicare accreditation program 
standards to our current Medicare RHC conditions for certification.
     A documentation review of AAAASF's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AAAASF's ability to provide continuous surveyor 
training.
    ++ Compare AAAASF's processes to those we require of State survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited RHCs.
    ++ Evaluate AAAASF's procedures for monitoring RHCs it has found to 
be out of compliance with AAAASF's program requirements. (This pertains 
only to monitoring procedures when AAAASF identifies non-compliance. If 
noncompliance is identified by a State survey agency through a 
validation survey, the State survey agency monitors corrections as 
specified at Sec.  488.9(c)(1).)
    ++ Assess AAAASF's ability to report deficiencies to the surveyed 
RHC and respond to the RHC's plan of correction in a timely manner.
    ++ Establish AAAASF'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 AAAASF's staff and other resources.
    ++ Confirm AAAASF's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AAAASF's policies with respect to surveys being 
unannounced.
    ++ Obtain AAAASF'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 September 
25, 2015 proposed notice also solicited public comments regarding 
whether AAAASF's requirements met or exceeded the Medicare conditions 
for certification for RHCs. 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 Conditions and Survey Requirements

    We compared AAAASF's RHC accreditation requirements and survey 
process with the Medicare conditions for certification at part 491, 
subpart A and the survey and certification process requirements at 
parts 488 and 489. We reviewed AAAASF's RHC accreditation program 
application as described in section III of this final notice. In 
response to our request AAAASF revised its standards and certification 
processes to ensure that its surveyors complete the required number of 
medical record reviews for each accredited facility.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve AAAASF as a national accreditation 
organization for RHCs that request participation in the Medicare 
program, effective March 23, 2016 through March 23, 2022.

V. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995.

    Dated: February 9, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-04092 Filed 2-24-16; 8:45 am]
 BILLING CODE 4120-01-P