[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]               
[Page 67522-67524]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-94]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2898-FN]

 
Medicare and Medicaid Programs; Approval of the Joint Commission 
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 Joint 
Commission 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, 2014.

FOR FURTHER INFORMATION CONTACT: Laura Weber, (410) 786-0227. 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 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

[[Page 67523]]

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 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 
Medicare requirements. (We note that section 125 of MIPPA redesignated 
subsections (b) through (e) of subsection 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 Joint Commission's 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 that 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 36518), we published 
a proposed notice announcing the Joint Commission'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 Joint Commission 
application in accordance with the criteria specified by our 
regulation, which include but are not limited to the following:
     An onsite administrative review of the Joint Commission'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 the Joint Commission's ASC accreditation 
standards to our current Medicare ASC conditions for coverage.
     A documentation review of the Joint Commission's survey 
processes to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and the ability of the Joint Commission to provide 
continuing surveyor training;
    ++ Compare the Joint Commission'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 the Joint Commission's procedures for monitoring 
providers or suppliers found to be out of compliance with the Joint 
Commission program requirements. The monitoring procedures are used 
only when the Joint Commission identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d);
    ++ Assess the Joint Commission's ability to report deficiencies to 
the surveyed facilities and respond to the facility's plan of 
correction in a timely manner;
    ++ Establish the Joint Commission's ability to provide us with 
electronic data and reports necessary for effective validation and 
assessment of the Joint Commission's survey process;
    ++ Determine the adequacy of staff and other resources;
    ++ Review the Joint Commission's ability to provide adequate 
funding for performing required surveys;
    ++ Confirm the Joint Commission's policies with respect to whether 
surveys are announced or unannounced; and,
    ++ Obtain the Joint Commission'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 
section 1865(b)(3)(A) of the Act), the June 27, 2008 proposed notice 
also solicited public comments regarding whether the Joint Commission'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 Joint Commission's Standards and 
Requirements for Accreditation and Medicare's Conditions and Survey 
Requirements

    We compared the standards contained in the Joint Commission's 
accreditation requirements for ASCs and its survey process in the Joint 
Commission's application for renewal of deeming authority for ASCs with 
the Medicare ASC conditions for participation and our State Operations 
Manual (SOM). Our review and evaluation of the Joint Commission's 
deeming application, which were conducted as described in section III. 
of this final notice, yielded the following:
     The Joint Commission amended their policies to eliminate 
the use of supplemental findings. All survey findings will be 
identified as a requirement for improvement, and will, therefore, 
require resolution through the evidence of standards compliance 
process.
     The Joint Commission modified its evidence of standards 
compliance process (ESC) to ensure that accepted ESCs contain the 
critical information necessary to provide assurance that an identified 
deficiency had been adequately corrected.
     The Joint Commission modified its survey report to clearly 
identify whether an identified deficient practice represented condition 
level- or standard-level noncompliance.

[[Page 67524]]

     The Joint Commission developed and conducted surveyor 
training on CMS documentation requirements to ensure that issues cited 
provide a clear and detailed description of the deficient practice and 
relevant finding.
     The Joint Commission modified its policies regarding 
complaint investigation activities to comply with the requirements at 
Sec.  488.4(a)(6) and Chapter 5 of the SOM.
     To meet the Medicare requirements related to unannounced 
surveys at 2700A of the SOM, the Joint Commission modified its 
electronic application process to no longer allow an ASC to indicate 
``avoid dates'' or ``a ready month'' in which organizations could 
receive an accreditation survey for deemed status.
     The Joint Commission revised its accreditation decision 
letters to ensure they are accurate and contain all the required 
elements necessary for the CMS Regional Office to render a decision 
regarding deemed status of a provider.
     The Joint Commission 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 requirements at Sec.  416.41, the Joint 
Commission revised its standards to require that patients in Medicare-
certified ASC that require emergency treatment beyond the capability of 
the ASC be transferred to local hospitals that meet requirements for 
payment of emergency services.
     To meet the requirements at Sec.  416.44(a)(2), the Joint 
Commission revised its standards to require Medicare certified ASCs to 
provide a separate waiting area and post-anesthesia room.
     To meet the requirements at Sec.  416.44(b)(1) and Sec.  
416.44(b)(5), Sec.  416.45(a), and Sec.  416.48(a), the Joint 
Commission amended its Medicare crosswalk to reflect current regulatory 
language.
     To meet the requirements at Sec.  416.45, the Joint 
Commission added a standard requiring Medicare-certified ASCs to ensure 
that licensed independent practitioners are accountable to the 
governing body.
     To meet the requirements at Sec.  416.45(b), the Joint 
Commission added a standard requiring Medicare-certified ASCs to 
periodically review and amend the scope of procedures performed.
     To meet the requirements at Sec.  416.48, the Joint 
Commission added a new standard requiring Medicare-certified ASCs to 
designate one individual responsible for pharmaceutical services.
     To meet the requirements at Sec.  416.49, the Joint 
Commission added a standard requiring Medicare-certified ASCs to comply 
with 42 CFR part 493 which requires organizations who perform 
laboratory testing to maintain compliance with Clinical Laboratory 
Improvement Amendments of 1988 (CLIA '88).

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that the Joint Commission's 
requirements for ASCs meet or exceed our requirements. Therefore, we 
approve the Joint Commission as a national accreditation organization 
for ASCs that request participation in the Medicare program, effective 
December 20, 2008 through December 20, 2014.

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. E8-27120 Filed 11-13-08; 8:45 am]

BILLING CODE 4120-01-P