2010-17405. Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued Deeming Authority for Hospices

AGENCY:

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

ACTION:

Final notice of Removal of Conditional Probationary Status.

SUMMARY:

Based on our review and observations, we have determined that the standards and processes used by the Community Health Accreditation Program (CHAP) hospice accreditation program meet or exceed our requirements. This final notice announces our decision to approve without condition CHAP's request for continued recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.

DATES:

Effective Date: This final notice is effective November 20, 2009 through November 20, 2012.

FOR FURTHER INFORMATION CONTACT:

Cindy Melanson, [phone].

Patricia Chmielewski [phone].

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 entities 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 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 provides that, if a provider entity demonstrates through accreditation by an approved national accreditation organization (AO) that all applicable Medicare conditions or requirements are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.

A national AO applying for approval of deeming authority under part 488, subpart A, must provide us with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning re-approval of AOs are set forth at § 488.4 and § 488.8(d)(3). The regulations at § 488.8(d)(3) require AOs to reapply for continued approval of deeming authority every 6 years, or sooner as determined by CMS. The regulation at § 488.8(f)(3)(i) provides CMS the authority to grant conditional approval of an AO's deeming authority, with a probationary period of up to 180 days, if the AO has not adopted comparable standards during the reapplication process.

We received a complete application from CHAP for continued recognition as a national AO for hospices on March 27, 2009. In accordance with the requirements at § 488.4 and § 488.8(d)(3), we published a proposed notice on May 22, 2009 (74 FR 24015) and a final notice announcing our decision to conditionally approve CHAP's hospice program subject to probationary conditions on October 23, 2009 (74 FR 54832). This final notice provides CMS' final determination in response to the conditional approval with a 180-day probationary period granted to CHAP on October 23, 2009. This notice is required to be published no later than July 18, 2010.

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. In accordance with § 488.8(f)(2), if CMS determines following the deeming authority review that the organization has failed to adopt requirements comparable to CMS requirements, the AO may be given a conditional approval of its deeming authority for a probationary period of up to 180 days to adopt comparable requirements. Within 60 days after the end of this period, we must make a final determination as to whether or not the CHAP accreditation program for hospices is comparable to CMS requirements and issue an appropriate notice that includes our reasons for our determination.

III. Provisions of the October 23, 2009 Final Notice

Our review of CHAP's renewal application for hospice deeming authority revealed that CHAP had on-going, serious, widespread areas of non-compliance. Specifically, CHAP's inability to provide us with accurate, timely data on deemed providers; lack of complete and accurate deemed facility survey files; and, failure to ensure that recertification surveys are conducted on an interval not exceeding 36 months. Due to the significant number of areas of noncompliance identified during the review of CHAP's deeming authority, we conditionally approved CHAP's hospice accreditation program with a 180 day probationary period. Under 1865(a)(2) of the Act and our regulations at § 488.4 and § 488.8, we conducted a comparability review of CHAP's hospice accreditation program to determine compliance with Medicare requirements for hospices at 42 CFR part 418.

IV. Provisions of the Final Notice

A. Differences Between CHAP's Standards and Requirements for Accreditation and Medicare's Conditions and Survey Requirements

During the 180 day probationary period, we conducted a comparison of CHAP's accreditation requirements for hospices to our current Medicare conditions of Participation (CoPs) as outlined in the State Operations Manual (SOM). We also conducted a corporate onsite visit to validate proper application of the requirements. Our review and evaluation of CHAP's deeming application yielded the following:

• CHAP's survey files were complete, accurate, and consistent with the requirements at § 488.6(a).
• CHAP's recertification surveys for hospices are conducted no later than 36 months after the date of the previous standard survey in accordance with the requirements at § 488.20(a).
• CHAP's data submission are accurate, complete and timely in accordance with the requirements at § 488.4(b).
• CHAP met the requirements at section 2728 of the SOM by developing an electronic plan of correction that specifically addressed the “who, what, when, and how” the hospice would correct each deficiency cited and ensure ongoing compliance.
• CHAP met requirements at § 488.28(a) and section 2728 of the SOM as evidenced by review of the survey files.
• CHAP policy regarding establishment of an effective date for new providers is consistent with the requirements at § 488.13.

B. Term of Approval

Based on the review and observations, we have determined that CHAP's hospice accreditation program meets or exceeds our requirements. Therefore, we approve CHAP as a national AO for hospices that request participation in the Medicare program, effective November 20, 2009 through November 20, 2012. Under § 488.8(f)(4), notice was given to CHAP on October 23, 2009 (74 FR 54832).

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. 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—Supplementary Medical Insurance Program)

Dated: June 29, 2010.

Marilyn Tavenner,

Acting Administrator and Chief Operating Officer, Centers for Medicare & Medicaid Services.