Notice2026-04544
Medicare and Medicaid Programs; Announcement of Applications From 12 Hospitals Requesting Waivers for Organ Procurement Service Area
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Published
March 9, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice acknowledges the receipt of applications from 12 hospitals that have requested a waiver of statutory requirements that would otherwise require the hospitals to enter into an agreement with their 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 waivers.
Full Text
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<title>Federal Register, Volume 91 Issue 45 (Monday, March 9, 2026)</title>
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[Federal Register Volume 91, Number 45 (Monday, March 9, 2026)]
[Notices]
[Pages 11319-11320]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1862-NC]
Medicare and Medicaid Programs; Announcement of Applications From
12 Hospitals Requesting Waivers 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 applications from 12
hospitals that have requested a waiver of statutory requirements that
would otherwise require the hospitals to enter into an agreement with
their 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
waivers.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by May 8, 2026.
ADDRESSES: In commenting, refer to file code CMS-1862-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-1862-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-1862-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: Lindsay Pulliam, (410) 786-8674.
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, under 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 designated OPO to identify potential
donors.
Section 1138(a)(2)(A) of the Act provides that a hospital may
submit a request to the Secretary of the Department of Health and Human
Services (the Secretary) for a waiver of the above requirements. If the
requested waiver meets certain conditions specified in section
1138(a)(2)(A) of the
[[Page 11320]]
Act, the Secretary shall grant the waiver and allow the hospital to
have an agreement with an OPO other than the one designated by CMS. The
Secretary may consider factors described in section 1138(a)(2)(B) of
the Act when determining whether to grant the hospital's request for a
waiver.
Section 1138(a)(2)(A) of the Act states that the Secretary shall
grant a waiver if he determines 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 factors that include but are
not limited to: (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. The regulations
identifying the relevant considerations are codified in 42 CFR
486.308(e) and (f).
II. Solicitation of Public Comments
Section 1138(a)(2)(D) of the Act states the Secretary shall publish
a public notice of any waiver application received from a hospital
within 30 days of receiving such application and offer interested
parties the opportunity to submit written comments to the Secretary
during the 60-day period beginning on the date such notice is
published. This notice applies to 12 separate requests by 12 hospitals
to each enter into an agreement with an OPO other than the OPO
designated for the service area in which each hospital is located.
Commenters must clearly identify the specific hospital to which each
comment applies. Commenters can identify specific hospitals using the
information found in Table 1. If a comment does not identify a specific
hospital or hospitals, we will assume the comment applies to all 12
hospitals.
As part of the process of determining whether to grant a hospital's
waiver request, we will review the applicable comments received. During
the review process, we may consult with relevant parties, including but
not limited to, 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 clarifying
information from the applying hospitals or others. We will then make a
final determination on each waiver request and notify the hospitals and
the designated and requested OPOs.
III. Hospital Waiver Requests
As permitted by Sec. 486.308(e), each of the hospitals identified
in Table 1 has requested a waiver to enter into an agreement with an
OPO other than the OPO designated for the service area in which the
hospital is located:
Table 1--Hospitals Requesting Waivers To Enter Into an Agreement with an OPO Other Than Their Designated OPO
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Name of hospital City State Designated OPO Requested OPO
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Prisma Health-Upstate d/b/a Easley............ SC................ SCOP.............. NCCM
Prisma Health Baptist Easley
Hospital O/P Therapy Services.
Prisma Health-Midlands d/b/a Columbia.......... SC................ SCOP.............. NCCM
Prisma Health Baptist Hospital.
Prisma Health-Midlands d/b/a Columbia.......... SC................ SCOP.............. NCCM
Prisma Health Baptist Parkridge.
Prisma Health-Upstate d/b/a Greenville........ SC................ SCOP.............. NCCM
Prisma Health Pediatrics Verdae.
Prisma Health-Upstate d/b/a Greer............. SC................ SCOP.............. NCCM
Prisma Health Greer Memorial
Hospital.
Prisma Health-Upstate d/b/a Simpsonville...... SC................ SCOP.............. NCCM
Prisma Health Hillcrest
Hospital.
Prisma Health-Upstate d/b/a Clinton........... SC................ SCOP.............. NCCM
Prisma Health Laurens County
Hospital.
Prisma Health-Upstate d/b/a Travelers Rest.... SC................ SCOP.............. NCCM
Prisma Health North Greenville
LTACH.
Prisma Health-Upstate d/b/a Seneca............ SC................ SCOP.............. NCCM
Prisma Health Oconee Memorial
Hospital.
Prisma Health-Upstate d/b/a Greenville........ SC................ SCOP.............. NCCM
Prisma Health Patewood Hospital.
Prisma Health-Midlands d/b/a Columbia.......... SC................ SCOP.............. NCCM
Prisma Health Richland Hospital.
Prisma Health Tuomey d/b/a Sumter............ SC................ SCOP.............. NCCM
Prisma Health Tuomey Hospital.
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IV. Keys to the OPO Codes
The keys to the acronyms used in the listings to identify OPOs and
their addresses are as follows:
SCOP We are Sharing Hope SC, 2215 Henry Tecklenburg Drive, Charleston,
SC 29414
NCCM LifeShare Carolinas, 3621 Randolph Road, Suite 100, Charlotte,
North Carolina 28211
V. 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.).
VI. Response to Comments
We will consider all comments we receive by the date and time
specified in the DATES section of this document.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Mehmet Oz, having reviewed and approved this document,
authorizes Vanessa Garcia, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2026-04544 Filed 3-6-26; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on March 9, 2026.
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