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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-2294-FN]

# AGENCY:

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

# ACTION:

Final notice.

# SUMMARY:

                        This final notice announces the approval of a deeming application from the Joint Commission for continued recognition as a national                               ( print page 13440)                            accreditation program for hospices that request participation in the Medicare or Medicaid programs.                    

# EFFECTIVE DATE:

This final notice is effective June 18, 2009 through June 18, 2015.

# FOR FURTHER INFORMATION CONTACT:

Alexis Prete, (410) 786-0375.

Patricia Chmielewski, (410) 786-6899.

# SUPPLEMENTARY INFORMATION:

## I. Background

Under the Medicare program, eligible beneficiaries may receive covered services in a hospice provided certain requirements are met. Section 1861(dd)(1) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a hospice program. Under this authority, the regulations at 42 CFR part 418 specify the conditions that a hospice must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for hospice care. Provider agreement regulations are located in 42 CFR part 489 and regulations pertaining to the survey and certification of facilities are located in 42 CFR part 488.

Generally, in order to enter into an agreement, a hospice facility must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 418 of our regulations. Then, the hospice is subject to regular surveys by a State survey agency to determine whether it continues to meet these 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 would “deem” those provider entities as having met the requirements. (We note that section 125 of MIPPA redesignated subsections (b) and (e) of subsection 1865 of the Act as (a) and (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, any provider entity accredited by the national accrediting body's approved program would 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 determined by CMS. The Joint Commission's term of approval as a recognized accreditation program for Hospice facilities expires June 18, 2009.

## II. Deeming Applications Approval Process

                    Section 1865(a)(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 than a 30 day public comment period. At the end of the 210-day period, we must publish a notice in the                     **Federal Register**                     of our approval or denial of the application.                

## III. Proposed Notice

On November 28, 2008 we published a proposed notice (73 FR 72487) announcing the Joint Commission's request for reapproval as a deeming organization for hospices. In this notice we specified in detail our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at § 488.4 (Application and reapplication procedures for accreditation organizations), we conducted a review of the Joint Commission's application in accordance with the criteria specified in our regulation, which include, but are not limited to the following:
    - An onsite administrative review of the Joint Commissions—(1) corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its surveyor; (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 hospice accreditation standards to our current Medicare conditions for participation.
    - 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 that 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 with the Joint Commission identifies noncompliance. If noncompliance is identified through validation reviews, the 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.
    - 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, the November 28, 2008 proposed notice (73 FR 72487) also solicited public comments regarding whether the Joint Commission's requirements met or exceeded the Medicare conditions of participation for hospices. We received no public comments in response to our proposed notice.

## IV. Provisions of the Final Notice

### A. Differences Between the Joint Commission Standards and Requirements and Medicare's Conditions and Survey Requirements

                    We compared the standards contained in the Joint Commission's                           ( print page 13441)                        “Comprehensive Accreditation Manual for Home Care” (CAMHC) and its survey process in the “Surveyor Activity Guide” with the Medicare hospice 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 notice yielded the following:                
    - On June 5, 2008, CMS published a final rule ( 73 FR 32088 ) that revised the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid Program. In accordance with the regulations at § 488.4(a)(3)(iv), the Joint Commission updated and revised their standards and survey procedures to meet the Medicare requirements.
    - To meet the Medicare requirements at section 2728 of the SOM, the Joint Commission modified its policies for posting the deemed status survey results within 10 days onto its extranet site.
    - The Joint Commission will conduct all for-cause surveys on an unannounced basis.
    - The Joint Commission modified its executive summary statement to clearly indicate that providers must meet all accreditation standards in order to be recommended for deemed status.

### 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 hospices meet or exceed our requirements. Therefore, we recognize the Joint Commission as a national accreditation organization for hospices that request participation in the Medicare program, effective June 18, 2009 through June 18, 2015.

## V. Collection of Information Requirements

This final notice does not impose any information collection and record keeping requirements. Consequently, it does not need to be reviewed by the Office of Management and Budget (OMB) 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—Hospital Insurance Program; and No. 93.774, Medicare—Supplemental Medical Insurance Program)

Dated: March 4, 2009.

Charlene Frizzera,

Acting Administrator, Centers for Medicare & Medicaid Services.

[FR Doc. E9-6775 Filed 3-26-09; 8:45 am]

BILLING CODE 4120-01-P