[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)] [Notices] [Pages 11687-11688] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-6089] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration [HCFA-1013-NC] Medicare and Medicaid Programs; Announcement of Additional Application From Hospital Requesting Waiver for Organ Procurement Service Area AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: This notice announces an additional application that HCFA has received from a hospital requesting waiver from dealing with its designated organ procurement organization (OPO) in accordance with section 1138(a)(2) of the Act. This notice requests comments from OPOs and the general public for our consideration in determining whether such a waiver should be granted. DATES: Written comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on May 11, 1998. ADDRESSES: Mail written comments (one original and three copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA-1013-NC, PO Box 7517, Baltimore, MD 21244-0517. If you prefer, you may deliver your written comments (one original and three copies) to one of the following addresses: Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC 20201, or Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code HCFA-1013-NC. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 309-G of the Department's offices at 200 Independence Avenue, SW, Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: (202) 690-7890). FOR FURTHER INFORMATION CONTACT: Mark A. Horney (410) 786-4554. SUPPLEMENTARY INFORMATION: I. Background Section 1138(a)(1)(A) of the Social Security Act (the Act) provides that a hospital or rural primary care hospital that participates in the Medicare or Medicaid programs must establish written protocols for the identification of potential organ donors. Section 155 of the Social Security Act Amendments of 1994 (SSA '94) (Pub. L. 103-432) amended section 1138 of the Act to require that effective January 1, 1996, a hospital must notify the organ procurement organization designated for the service area in which it is located of potential organ donors (sections 1138(a)(1)(A)(iii) and (a)(3)(B) of the Act). The hospital must also have an agreement to do so only with that designated OPO (sections 1138(a)(1)(C) and (a)(3)(A)). The statute also provides that the hospital may obtain a waiver of these requirements from the Secretary. A waiver would allow the hospital to have an agreement with an ``out-of-area'' OPO (section 1138(a)(2)) if it meets conditions specified in the statute (section 1138(a)(2)(A)(i) and (ii)). The law further states that in granting a waiver, the Secretary must determine that such a waiver: (1) Would be expected to increase donations; and (2) will assure equitable treatment of patients referred for transplants within the service area served by the designated OPO and within the service area served by the out-of-area OPO (section 1138(a)(2)(A)). In making a waiver determination, the Secretary may consider, among other factors: (1) Cost effectiveness; (2) improvements in quality; (3) whether there has been any change in a hospital's designated OPO service area due to the definition of metropolitan statistical areas (MSAs); and (4) the length and continuity of a hospital's relationship with the out-of-area OPO (section 1138(a)(2)(B)). Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver applications within 30 [[Page 11688]] days of receiving the application and offer interested parties an opportunity to comment in writing within 60 days of the published notice. Regulations at 42 CFR 486.316(d) provide that if HCFA changes the OPO designated for an area, hospitals located in that area must enter into agreements with the newly designated OPO or submit a request for a waiver within 30 days of notice of the change in designation. The criteria that the Secretary will use to evaluate the waiver in these cases are the same as that described above under section 1138(a)(2)(A) of the Act and incorporated in the regulations at Sec. 486.316(e). The regulations further specify that a hospital may continue to operate under its existing agreement with an out-of-area OPO while HCFA is processing the waiver request. II. Waiver Request Procedures In October 1995, we issued a Program Memorandum (Transmittal No. A- 95-11) that has been supplied to each hospital. This Program Memorandum detailed the waiver process and discussed the information that hospitals must provide in requesting a waiver. We indicated that upon receipt of the waiver requests, we would publish a Federal Register notice to solicit public comments, as required by law (section 1138(a)(2)(D)). We will then review the requests and comments received. During the review process, we may consult on an as-needed basis with agencies outside the HCFA Central Office, including the Public Health Service's Division of Transplantation, the United Network for Organ Sharing, and HCFA regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We then will make a final determination on the waiver requests and notify the affected hospitals and OPOs. III. Additional Hospital Waiver Request As allowed under Sec. 483.316(d), the following hospital has requested a waiver to have an agreement with an alternative, out-of- area OPO, as a result of changes in its designated OPO due to the latest redesignation of OPO service areas. The listing includes the name of the facility, the city and State location of the facility, the requested OPO, and the currently designated area OPO. The hospital has submitted a timely waiver request and may work on an interim basis with the requested out-of-area OPO, pending receipt of public comments and our final determination. ---------------------------------------------------------------------------------------------------------------- Name of facility City State Requested OPO Designated OPO ---------------------------------------------------------------------------------------------------------------- Baptist Memorial Hospital-- New Albany........ MS................. TNMS.............. MSOP. Union County. ---------------------------------------------------------------------------------------------------------------- IV. Keys to the OPO Codes The keys to the acronyms used in the listing to identify OPOs and their addresses are as follows: MSOP--MISSISSIPPI ORGAN RECOVERY AGENCY, 12 River Bend Place, Jackson, MS 39208 TNMS--MID-SOUTH TRANSPLANTATION FOUNDATION, 956 Court Avenue, Memphis, TN 38163. V. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information to be collected. The information collection requirement and the burden associated with requiring a Medicare or Medicaid participating hospital to have an agreement with the OPO designated for its area or to submit a waiver request to HCFA for approval to have an agreement with a designated OPO other than the OPO designated for its service area currently are approved by OMB. Authority: Sec. 1138 of the Social Security Act (42 U.S.C. 1320b-8). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, and No. 93.778, Medical Assistance Program) Dated: February 27, 1998. Kathleen A. Buto, Acting Director, Center for Health Plans and Providers, Health Care Financing Administration. [FR Doc. 98-6089 Filed 3-9-98; 8:45 am] BILLING CODE 4120-01-P