Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area, 68160-68161 [2022-24715]

Download as PDF 68160 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 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: Mooresville Hospital Management Associates, LLC d/b/a Lake Norman Regional Medical Center, Mooresville, North Carolina, is requesting a waiver to work with: LifeShare Carolinas, 5000 D Airport Center Parkway, Charlotte, North Carolina 28208. The Hospital’s Designated OPO is: HonorBridge, 1430 WestBrook Plaza Drive, Winston-Salem, North Carolina 27103. 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 preamble. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: November 8, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2022–24716 Filed 11–10–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services khammond on DSKJM1Z7X2PROD with NOTICES [CMS–1791–NC] Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with request for comment. AGENCY: VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements to enter into an agreement with an organ procurement organization (OPO) other than its designated organ procurement organization. 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 13, 2023. ADDRESSES: In commenting, refer to file code CMS–1791–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–1791–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–1791–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 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 SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 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 CMSdefined 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 E:\FR\FM\14NON1.SGM 14NON1 68161 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 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 § 486.308(e) and (f). khammond on DSKJM1Z7X2PROD with NOTICES 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: North Carolina Baptist Hospital, Winston-Salem, North Carolina, is requesting a waiver to work with: LifeShare Carolinas, 5000 D Airport Center Parkway, Charlotte, North Carolina 28208. The Hospital’s Designated OPO is: HonorBridge, 1430 WestBrook Plaza Drive, Winston-Salem, North Carolina 27103. IV. Collection of Information Requirements purposes of publication in the Federal Register. Dated: November 8, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2022–24715 Filed 11–10–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9138–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2022 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: 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 preamble. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2022, relating to the Medicare and Medicaid programs and other programs administered by CMS. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. SUMMARY: Addenda Contact I CMS Manual Instructions ................................................................................................................... II Regulation Documents Published in the Federal Register ............................................................. III CMS Rulings .................................................................................................................................... IV Medicare National Coverage Determinations ................................................................................. V FDA-Approved Category B IDEs ...................................................................................................... VI Collections of Information ................................................................................................................ VII Medicare-Approved Carotid Stent Facilities ................................................................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites ............................ IX Medicare’s Active Coverage-Related Guidance Documents .......................................................... X One-time Notices Regarding National Coverage Provisions ........................................................... XI National Oncologic Positron Emission Tomography Registry Sites ............................................... XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ............................ XIII Medicare-Approved Lung Volume Reduction Surgery Facilities .................................................. XIV Medicare-Approved Bariatric Surgery Facilities ............................................................................ XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials .................................... All Other Information ............................................................................................................................ Ismael Torres ................ Terri Plumb ................... Tiffany Lafferty .............. Wanda Belle, MPA ....... John Manlove ............... William Parham ............. Sarah Fulton, MHS ....... Sarah Fulton, MHS ....... JoAnna Baldwin, MS ..... JoAnna Baldwin, MS .... David Dolan, MBA ........ David Dolan, MBA ........ Sarah Fulton, MHS ....... Sarah Fulton, MHS ....... David Dolan, MBA ........ Annette Brewer ............. SUPPLEMENTARY INFORMATION: I. Background The Centers for Medicare & Medicaid Services (CMS) is responsible for VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Phone number (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–3365 786–3365 786–2749 786–2749 786–3365 786–6580 administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight E:\FR\FM\14NON1.SGM 14NON1

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[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68160-68161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1791-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.

-----------------------------------------------------------------------

SUMMARY: This notice acknowledges the receipt of an application from a 
hospital that has requested a waiver of statutory requirements to enter 
into an agreement with an organ procurement organization (OPO) other 
than its designated organ procurement organization. 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 13, 2023.

ADDRESSES: In commenting, refer to file code CMS-1791-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-1791-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-1791-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 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

[[Page 68161]]

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:
    North Carolina Baptist Hospital, Winston-Salem, North Carolina, is 
requesting a waiver to work with: LifeShare Carolinas, 5000 D Airport 
Center Parkway, Charlotte, North Carolina 28208.
    The Hospital's Designated OPO is: HonorBridge, 1430 WestBrook Plaza 
Drive, Winston-Salem, North Carolina 27103.

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 preamble.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: November 8, 2022.
Lynette Wilson,
 Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-24715 Filed 11-10-22; 8:45 am]
BILLING CODE 4120-01-P

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