This document is scheduled to be published in the

Federal Register on 05/12/2014 and available online at

http://federalregister.gov/a/2014-10638, and on FDsys.gov

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services 

[CMS-1618-NC] 

Medicare and Medicaid Programs; Announcement of Application from a Hospital 

Requesting Waiver for Organ Procurement Service Area 

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

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a waiver of statutory requirements that would 

otherwise require the hospital to enter into an agreement with its designated Organ 

Procurement Organization (OPO). The request was made in accordance with the Social 

Security Act (the Act). This notice requests comments from OPOs and the general public 

for our consideration in determining whether we should grant the requested waiver. 

DATES: Comment Date: To be assured consideration, comments must be received at 

one of the addresses provided below, no later than 5 p.m. on [INSERT DATE 60 DAYS 

AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 

ADDRESSES: In commenting, refer to file code CMS-1618-NC. Because of staff and 

resource limitations, we cannot accept comments by facsimile (FAX) transmission. 

 You may submit comments in one of four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit electronic comments on this regulation to 

http://www.regulations.gov. Follow the "Submit a comment" instructions. 

 2. By regular mail. You may mail written comments to the following address 

ONLY: 
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 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 comments 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. Alternatively, you may deliver (by hand or courier) your 

written comments to a regulations staff member ONLY to the following 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 20201 
 3

(Because access to the interior of the Hubert 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 for persons wishing to retain 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 schedule your arrival with one of our staff 

members. 

Comments erroneously mailed to the addresses indicated as appropriate for hand 

or courier delivery may be delayed and received after the comment period. 

For information on viewing public comments, 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 personally identifiable or 

confidential business information that is included in a comment. We post all comments 
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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 available for public inspection as they are 

received, generally beginning approximately 3 weeks after publication of a document, at 

the headquarters of the Centers 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 appointment to view public comments, phone 

1-800-743-3951. 

I. Background 

Organ Procurement Organizations (OPOs) are not-for-profit organizations that are 

responsible for the procurement, preservation, and transport of organs to transplant 

centers throughout the country. Qualified OPOs are designated by the Centers for 

Medicare & Medicaid Services (CMS) to recover 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 which it is located) of potential organ donors. 

Under section 1138(a)(1)(C) of the Act, every participating hospital must have an 
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agreement only with its designated OPO to identify potential donors. 

However, section 1138(a)(2)(A) of the Act 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 OPO other than the one initially designated by 

CMS, if the hospital meets certain conditions specified in section 1138(a)(2)(A) of the 

Act. In addition, the Secretary may review additional criteria described 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 expected 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 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 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 than the hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any 

waiver application received from a hospital within 30 days of receiving the application, 

and to offer interested parties an opportunity 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 evaluate the waiver in these cases are the 
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same as those described above under sections 1138(a)(2)(A) and (B) of the Act and have 

been incorporated into the regulations 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 comments, 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 Transplantation, the 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 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 94607-4099 
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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 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). 

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]