Centers for Medicare & Medicaid Services (CMS), HHS.
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.
Effective Date: This final notice is effective December 20, 2008, through December 20, 2014.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Laura Weber, (410) 786-0227. Patricia Chmielewski (410) 786-6899.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 67523survey 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 § 488.4 and § 488.8(d)(3). The regulations at § 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 § 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 § 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. Start Printed 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 § 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 § 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 § 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 § 416.44(b)(1) and § 416.44(b)(5), § 416.45(a), and § 416.48(a), the Joint Commission amended its Medicare crosswalk to reflect current regulatory language.
- To meet the requirements at § 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 § 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 § 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 § 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).
(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)Start Signature
Dated: October 2, 2008.
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-27120 Filed 11-13-08; 8:45 am]
BILLING CODE 4120-01-P