Notice2023-25902
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 24, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 225 (Friday, November 24, 2023)</title>
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[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82375-82376]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1817-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 January 23, 2024.
ADDRESSES: In commenting, refer to file code CMS-1817-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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-1817-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-1817-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: Randy Throndset, (410) 786-0131.
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 received before the close of the comment period on
the following website as soon as possible after they have been
received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions
on that website to view public comments. CMS will not post on
<a href="http://Regulations.gov">Regulations.gov</a> 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
establish protocols, which require the hospital to 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
[[Page 82376]]
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:
Renown Regional Medical Center, Reno, Nevada, is requesting a
waiver to work with:
Nevada Donor Network, Inc, 2055 E Sahara Ave., Las Vegas, NV 89104
The Hospital's Designated OPO is:
Donor Network West, 12667 Alcosta Blvd. #500, San Ramon, CA 94583
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 Chyana Woodyard, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: November 17, 2023.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-25902 Filed 11-22-23; 8:45 am]
BILLING CODE P
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