[Federal Register Volume 77, Number 228 (Tuesday, November 27, 2012)]
[Notices]
[Pages 70783-70785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3265-FN]
Medicare and Medicaid Programs; Approval of the Accreditation
Association for Ambulatory Health Care (AAAHC) Application for
Continuing CMS Approval of Its Ambulatory Surgical Center Accreditation
Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve the
Accreditation Association for Ambulatory Health Care (AAAHC) for
continued recognition as a national accrediting organization for
ambulatory surgical centers (ASCs) that wish to participate in the
Medicare and/or Medicaid programs.
DATES: Effective Date: This notice is effective December 20, 2012
through December 20, 2018.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636.
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 an ambulatory surgical center (ASC) provided
certain requirements are met. Section 1832(a)(2)(F)(i) of the Social
Security Act (the Act) requires ASCs to meet
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health, safety, and other standards specified by the Secretary.
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. The regulations at 42 CFR part
416 specify the conditions that an ASC must meet to participate in the
Medicare program, the scope of covered services, and the conditions for
Medicare payment for ASCs.
Generally, to enter into an agreement, an ASC must first be
certified by a State survey agency as complying with the conditions or
requirements set forth in part 416. Thereafter, the ASC is subject to
regular surveys by a State survey agency to determine whether it
continues to meet these requirements. However, there is an alternative
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 accrediting
organization that all applicable Medicare conditions are met or
exceeded, CMS will deem those provider entities as having met the
Medicare requirements. Accreditation by an accrediting organization is
voluntary and is not required for Medicare participation.
If an accrediting 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 would be deemed to meet the Medicare
conditions. A national accrediting organization applying for approval
of its accreditation program under part 488, subpart A, must provide us
with reasonable assurance that the accrediting organization requires
the accredited provider 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. 488.4 and
Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require
accrediting organizations to reapply for continued approval of its
accreditation program every 6 years or sooner as determined by CMS.
The Ambulatory Health Care's (AAAHC) current term of approval for
their ASC accreditation program expires on December 20, 2012.
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 accrediting body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from the receipt of a complete
application to publish a notice of approval or denial of the
application.
III. Provisions of the Proposed Notice
On June 22, 2012, we published a proposed notice in the Federal
Register (77 FR 37678) entitled, ``Application from the Accreditation
Association for Ambulatory Health Care for Continued Approval of Its
Ambulatory Surgical Centers Accreditation Program'' announcing the
AAAHC's request for continued approval of its ASC accreditation
program.
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 AAAHC's application in
accordance with the criteria specified by our regulations, 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.
The comparison of AAAHC's accreditation to CMS's current
Medicare ASC conditions for coverage.
A documentation review of AAAHC's survey process to--
+ Determine the composition of the survey team, surveyor
qualifications, and AAAHC's ability 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 ASC's found to be out
of compliance with AAAHC's 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 the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ Establish AAAHC'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 staff and other resources.
+ Confirm AAAHC's ability to provide adequate funding for
performing required surveys.
+ Confirm AAAHC's policies with respect to whether surveys are
announced or unannounced.
+ Obtain AAAHC'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 June 22,
2012 proposed notice also solicited public comments regarding whether
AAAHC's requirements met or exceeded the Medicare conditions for
coverage for ASCs. We received no public comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between AAAHC's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared AAAHC's ASC 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 AAAHC's
ASC application, which were conducted as described in section III of
this final notice, yielded the following:
To meet the requirements at Sec. 416.41(a), AAAHC revised
its standards to address all contracts.
To meet the requirements at Sec. 416.41(c)(1), AAAHC
revised its standards to address ``the emergency care of patients.''
To meet the requirements at Sec. 416.44, AAAHC revised
its standards to address the Life Safety Code (LSC) survey and created
a policy to ensure all ASCs receive a complete and comprehensive LSC
survey.
To meet the requirements at Sec. 416.47(a), AAAHC revised
its standards to address the use of patients records.
To meet the requirements at Sec. 416.47(b), AAAHC revised
its standards to address the requirement that every record must be
accurate, legible, and promptly completed.
To meet the requirements at Sec. 416.50(b)(1)(ii), AAAHC
revised its standards to ensure patients have the right to ``voice
grievances regarding treatment or care that is (or fails to be)
provided.''
To meet the requirements at Sec. 488.4(a)(5), AAAHC
modified its policies to improve the accuracy and consistency of data
submissions to CMS.
To meet the requirements at Sec. 488.4(a)(6), AAAHC
modified its
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policies to ensure that all compliant investigations are conducted in
accordance with the requirements in the SOM, chapter 5.
To meet the requirements at Sec. 488.28(a) and Section
2726 of the SOM, AAAHC amended its policies to require a Plan of
Correction (PoC) for all deficiencies cited.
To meet the requirements at section 2728A of the SOM,
AAAHC modified its policies to include all of the required elements in
an acceptable PoC.
To meet the requirements at 2728B of the SOM, AAAHC
modified its policies regarding timeframes for requesting PoCs.
To meet the requirements at section 2728B of the SOM,
AAAHC modified its policies to ensure that accepted PoCs contain all
elements specified in the SOM.
To meet the Medicare requirements at section 3012 of the
SOM related to focused and follow-up surveys, AAAHC amended its
policies to include the 45-day response timeframe.
To meet the requirements at Appendix L of the SOM--
Sampling for Initial Surveys, Recertification Surveys, or
Representative Sample Validation Surveys, AAAHC revised its policies to
ensure surveyors review at least the required minimum number of medical
records during a survey.
To meet the requirements at Appendix L of the SOM-- Use of
the Infection Control Tool, AAAHC revised its survey protocol to ensure
consistency, completeness and proper implementation of the Infection
Control Tool.
To verify AAAHC's continued compliance with the provisions
of the LSC, CMS will conduct a follow-up survey observation within 1
year of the date of publication of this final notice.
B. Term of Approval
Based on our 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, 2012 through December
20, 2018.
V. Collection of Information Requirements
This document does not impose any reporting, recordkeeping or
third-party disclosure 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; No. 93.773 Medicare--ASC Insurance Program; and
No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: November 20, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-28728 Filed 11-23-12; 8:45 am]
BILLING CODE 4120-01-P