[Federal Register Volume 88, Number 63 (Monday, April 3, 2023)]
[Notices]
[Pages 19646-19647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1798-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 request for comment.

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SUMMARY: This notice acknowledges the receipt of an application from a 
hospital that 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). 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, by June 2, 2023.

ADDRESSES: In commenting, refer to file code CMS-1798-NC.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1798-NC, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    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-1798-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:  Caitlin Bailey, (410) 786-9768.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the

[[Page 19647]]

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 received before the close 
of the comment period on the following website as soon as possible 
after they have been received: https://www.regulations.gov. Follow the 
search instructions on that website to view public comments. CMS will 
not post on Regulations.gov public comments that make threats to 
individuals or institutions or suggest that the individual will take 
actions to harm the individual. CMS continues to encourage individuals 
not to submit duplicative comments. We will post acceptable comments 
from multiple unique commenters even if the content is identical or 
nearly identical to other comments.

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 hospital must have an 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 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 same as those described above under section 
1138(a)(2)(A) and (B) of the Act and have been incorporated into the 
regulations at Sec.  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 Sec.  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:
    Atrium Medical Center, Middletown, Ohio, is requesting a waiver to 
work with: Life Connection of Ohio, 3661 Briarfield Boulevard, Suite 
105, Maumee, OH 43537.
    The Hospital's Designated OPO is: LifeCenter Organ Donor Network, 
615 Elsinore Place, Suite 400, Cincinnati, OH 45202.

IV. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

V. Response to Comments

    We will consider all comments we receive by the date specified in 
the DATES section of this document.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Evell J. Barco Holland, who is the Federal 
Register Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: March 27, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-06764 Filed 3-31-23; 8:45 am]
BILLING CODE 4120-01-P