[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)] [Notices] [Pages 43198-43200] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-20403] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration [HCFA-1055-NC] Medicare and Medicaid Programs; Announcement of Additional Applications From Hospitals Requesting Waivers for Organ Procurement Service Areas AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: This notice announces additional applications that we have received from hospitals requesting waivers from entering into agreements with their designated organ procurement organizations. Section 1138(a)(2) of the Social Security Act allows the Secretary of the Department of Health and Human Services to grant waivers to hospitals that want to enter into an agreement with a specific OPO that is not the designated OPO for the hospital's service area. This notice requests comments from OPOs and the general public for our consideration in determining whether these waivers should be granted. COMMENT DATE: Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on October 8, 1999. ADDRESSES: Mail written comments (1 original and 3 copies) to the following address: Health Care Financing Administration, Department of Health [[Page 43199]] and Human Services, Attention: HCFA-1055-NC, P.O. Box 9016, Baltimore, MD 21244-9016. If you prefer, you may deliver your written comments (1 original and 3 copies) to one of the following addresses: Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or Room C5-14-03, 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-1055-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 443-G of the Department's offices at 200 Independence Avenue, SW., Washington, DC, Monday through Friday 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)(iii) of the Social Security Act (the Act) provides that a participating hospital must notify its designated organ procurement organization (OPO) of potential organ donors. The designated OPO, as defined under section 1138(a)(3)(B) of the Act, is determined by the service area in which the hospital is located. Under section 1138(a)(1)(C) of the Act, the hospital must have an agreement with only that designated OPO to identify potential organ donors. Section 1138(a)(2) of the Act provides that a participating hospital may obtain a waiver of these requirements from the Secretary of the Department of Health and Human Services (the Secretary). A waiver allows the hospital to have an agreement with an OPO other than the designated OPO if the conditions specified in section 1138(a)(2)(A) of the Act are met. Section 1138(a)(2)(A) states that in granting a waiver, the Secretary must determine that the waiver: (1) Is expected to increase organ donations; and (2) will ensure equitable treatment of patients referred for transplants within the service area served by the hospital's designated OPO and within the service area served by the OPO with which the hospital seeks to enter into an agreement under the waiver. In making a waiver determination, section 1138(a)(2)(B) of the Act provides that 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 changes made on or after December 28, 1992, in definition of metropolitan statistical areas (MSAs); and (4) the length and continuity of a hospital's relationship with the OPO other than the designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver application within 30 days of receiving the application and offer interested parties an opportunity to comment in writing within 60 days of the published notice. The regulations at 42 CFR 486.316(d) provide that if we change 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 uses to evaluate the waiver in these cases are the same as those described above under section 1138(a)(2)(A) of the Act and have been incorporated into the regulations at Sec. 486.316(e). Section 486.316(g) further specifies that a hospital may continue to operate under its existing agreement with an out-of- area OPO while we process its waiver request it submitted in accordance with Sec. 486.316(d). This notice supplements previous notices announcing OPO waivers published in the Federal Register on January 19, 1996 (61 FR 1389), May 17, 1996 (61 FR 24941), November 8, 1996 (61 FR 57876), April 21, 1997 (62 FR 19326), September 17, 1997 (62 FR 48872), September 23, 1998 (63 FR 50919), and January 12, 1999 (64 FR 1811). II. Waiver Request Procedures In October 1995, we issued a Program Memorandum (Transmittal No. A- 95-11) that was 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 section 1138(a)(2)(D) of the Act. We will review the requests and comments received. During the review process, we may consult, on an as-needed basis, with the Health Resources and Services Administration's Division of Transplantation; the Organ Procurement and Transplantation Network Contractor, United Network for Organ Sharing; and our regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver requests and notify the affected hospitals and OPOs. III. Hospital Waiver Requests As allowed under Sec. 486.316(e), each of the following hospitals has requested a waiver to have an agreement with an alternative, out- of-area OPO. The listing includes the name of the facility, the city and state of the facility, the currently designated area OPO and the requested OPO. ---------------------------------------------------------------------------------------------------------------- Name of facility City State Designated OPO Requested OPO ---------------------------------------------------------------------------------------------------------------- Keweenaw Memorial Hospital...... Laurium............ MI WIWU MIOP Jefferson Memorial Hospital..... Ranson............. WV DCTC VAOP Dickinson County Healthcare Iron Mountain...... MI WIWU MIOP System. ---------------------------------------------------------------------------------------------------------------- The following two hospitals have requested a waiver under Sec. 486.316 (e) for a reason unrelated to a change in the designated service area of an OPO. These waivers will only be effective upon completion of our review if the provider meets the requirement of Sec. 486.316 (e). ---------------------------------------------------------------------------------------------------------------- Name of facility City State Designated OPO Requested OPO ---------------------------------------------------------------------------------------------------------------- Fairview Hospital............... Great Barrington... MA MAOB NYAP Elko General Hospital........... Elko............... NV NVLV UTOP ---------------------------------------------------------------------------------------------------------------- [[Page 43200]] IV. Key to the OPO Codes The key to the acronyms used in the listings to identify OPOs and their addresses are as follows: DCTC--WASHINGTON REGIONAL TRANSPLANT CONSORTIUM, 8110 Gatehouse Road, Suite 101 W, Falls Church, VA 22042 MAOB--NEW ENGLAND ORGAN BANK, One Gateway Center, Newton, MA 02458 MIOP--ORGAN PROCUREMENT AGENCY OF MICHIGAN, 2203 Platt Road, Ann Arbor, MI 48104 NVLV--NEVADA DONOR NETWORK, 4850 Southeastern Avenue, Suite 33, Las Vegas, NV 89119 NYAP--CENTER FOR DONATION AND TRANSPLANT, 218 Great Oaks Blvd., Albany, NY 12203 UTOP--INTERMOUNTAIN ORGAN PROCUREMENT AGENCY, 230 South 500 East, Suite 290, Salt Lake City, UT 84102 VAOP--VIRGINIA ORGAN PROCUREMENT AGENCY, 1527 Houguenot Road, Midlothian, VA 23113 WIWU--UNIVERSITY OF WISCONSIN OPO, University of Wisconsin Hospitals and Clinics, 600 Highland Avenue, Madison, Wisconsin 53792 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 requirement 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 collection burden on the affected public, including automated collection techniques. Therefore, we are soliciting public comment on the following issue for the information collection requirements described below. Designation of one OPO for each service area: Section 486.316(e) states the requirements for a Medicare or Medicaid participating hospital to qualify for a waiver permitting the hospital to have an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located. The burden associated with these requirements is currently approved under OMB 0938-0688, HCFA-R-13, Conditions of Coverage for Organ Procurement Organizations, with an expiration date of November 30, 1999. If you comment on any of these information collection and recordkeeping requirements, please mail copies directly to the following: Health Care Financing Administration, Office of Information Services, Security and Standards Groups, Division of HCFA Enterprise Standards, Attention: Louis Blank, HCFA-1055-NC, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, and Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Allison Eydt, HCFA Desk Officer, Room 10235, New Executive Office Building, Washington, DC 20503. Authority: Section 1138 of the Social Security Act (42 U.S.C. 1320b-8). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance; Program No. 93.774 Medicare-- Supplementary Medical Insurance, and Program No. 93.778, Medical Assistance Program) Dated: August 2, 1999. Robert A. Berenson, Director, Center for Health Plans and Providers, Health Care Financing Administration. [FR Doc. 99-20403 Filed 8-6-99; 8:45 am] BILLING CODE 4120-01-P