T h i s d o c u m e n t i s s c h e d u l e d t o b e p u b l i s h e d i n t h e F e d e r a l R e g i s t e r o n 0 5 / 1 2 / 2 0 1 4 a n d a v a i l a b l e o n l i n e a t h t t p : / / f e d e r a l r e g i s t e r . g o v / a / 2 0 1 4 - 1 0 6 3 8 , a n d o n F D s y s . g o v2

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1618-NC, P.O. Box 8010, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comme nts to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1618-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. Alternativel y, you may deliver (by hand or courier) your written comments to a regulations staff me mber ONLY to the follo wing addresses: a. For delivery in Washington, DC--

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 202013

(Because access to the interior of the Hube rt H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available fo r persons wishing to re tain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD--

Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedul e your arrival with one of our staff

members. Comments erroneously mailed to the addres ses indicated as appropriate for hand or courier delivery may be delayed an d received after the comment period. For information on viewing public co mments, see the beginning of the

"SUPPLEMENTARY INFORMATION" section.

FOR FURTHER INFORMATION CONTACT: Patricia Taft, (410) 786-4561.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public , including any persona lly identifiable or confidential business information that is included in a comment. We post all comments4

received before the close of the comment period on the following web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search

instructions on that web site to view public comments. Comments received timely will also be av ailable for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Cent ers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an a ppointment to view public comments, phone

1-800-743-3951. I. Background Organ Procurement Organizations (OPOs) ar e not-for-profit organizations that are responsible for the procurement, preservati on, and transport of organs to transplant centers throughout the countr y. Qualified OPOs are designated by the Centers for Medicare & Medicaid Services (CMS) to re cover or procure organs in CMS-defined exclusive geographic service areas, pursuant to section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273( b)(1)) and our regulations at 42 CFR 486.306. Once an OPO has been designated for an area, hospitals in that area that participate in Medicare and Medicaid are required to work with that OPO in providing organs for transplant, pursuant to section 1138(a)(1)(C) of the Social Security Act (the Act) and our regulations at

42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must notify the designated OPO (for the service area in whic h it is located) of potential organ donors. Under section 1138(a)(1)(C) of the Act, ev ery participating hospital must have an5

agreement only with its designated OPO to identify potential donors. However, section 1138(a)(2)(A) of the Ac t provides that a hospital may obtain a waiver of the above requirements from the Secretary of the Department of Health and Human Services (the Secretary) under certain specified conditions. A waiver allows the hospital to have an agreement with an OP O other than the one initially designated by CMS, if the hospital meets cer tain conditions specified in section 1138(a)(2)(A) of the Act. In addition, the Secretary may review additional criteria de scribed in section 1138(a)(2)(B) of the Act to evaluate the hospital's request for a waiver. Section 1138(a)(2)(A) of the Act states that in granting a waiver, the Secretary must determine that the waiver--(1) is exp ected to increase organ donations; and (2) will ensure equitable treatment of patients referred for transplants within the service area served by the designated OPO and within the service area served by the OPO with which the hospital seeks to enter in to 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 due to the changes made in definitions for metropolitan statistical areas; and (4) the length and continuity of a hospital's relationship with an OPO other th an the hospital’s designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is requi red to publish a notice of any waiver application received from a hospital within 30 days of rece iving the application, and to offer interested parties an opport unity to submit comments during the 60-day comment period beginning on the publication date in the Federal Register

. The criteria that the Secretary uses to ev aluate the waiver in these cases are the6

same as those described above under sections 1138(a)(2)(A) and (B) of the Act and have been incorporated into the regul ations at § 486.308(e) and (f). II. Waiver Request Procedures In October 1995, we issued a Program Memorandum (Transmittal No. A-95-11) detailing the waiver process and discussing the information hospitals must provide in requesting a waiver. We indicated that upon receipt of a waiver request, we would publish a Federal Register notice to solicit public comm ents, as required by section 1138(a)(2)(D) of the Act. According to these requirements, we will review the comments received. During the review process, we may consult on an as -needed basis with the Health Resources and

Services Administration's Division of Tran splantation, the United Network for Organ Sharing, and our regional offices. If nece ssary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver request and notify the hospital and the designated and requested OPOs. III. Hospital Waiver Request As permitted by § 486.308(e), the following hospital has requested a waiver to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located: Banner Churchill Community Hospital, Fallon, Nevada, is requesting a waiver to work

with: California Transplant Donor Network 1000 Broadway, Suite 600 Oakland, California 94607-40997

The Hospital’s Designated OPO is:

Nevada Donor Network 2061 E Sahara Ave. Las Vegas, Nevada 89104 IV. Collection of Information Requirements This document does not impose inform ation collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperw ork Reduction Act of 1995 (44 U.S.C.35). V. Response to Public Comments We will consider all comments we receive by the date and time specified in the "DATES" section of this preamble.Dated: May 2, 2014.

Marilyn Tavenner Administrator,

Centers for Medicare & Medicaid Services.

BILLING CODE 4120-01-P

[FR Doc. 2014-10638 Filed 05/09/2014 at 8:45 am; Publication Date: 05/12/2014]