[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33313-33315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1576-N]


Medicare and Medicaid Programs; Procedure for Hospitals Seeking 
To Enter Into an Agreement With a Different Organ Procurement 
Organization Following an 1138(a)(2) Waiver

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

ACTION: Notice.

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[[Page 33314]]

SUMMARY: This notice announces the procedures that will be used when a 
hospital, that has previously been granted a waiver under sections 
1138(a)(2) of the Social Security Act (the Act), seeks to enter into an 
agreement with a different Organ Procurement Organization (OPO). The 
procedures are modeled after the public process required by 1138(a)(2) 
of the Act. The process affords the public an opportunity to comment on 
the proposed change and to submit information and material with respect 
to whether the change is likely to increase organ donation and will 
assure equitable treatment for patients in both affected OPO service 
areas.

DATES: Effective Date: This notice is effective June 11, 2010.

FOR FURTHER INFORMATION CONTACT: Mark A. Horney, (410) 786-4554.

SUPPLEMENTARY INFORMATION:

I. Background

    Organ Procurement Organizations (OPOs) are not-for-profit 
organizations that are responsible for the procurement, preservation, 
and transport of transplantable 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 Sec.  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 agreement to identify 
potential donors only with its designated OPO.
    However, section 1138(a)(2)(A) of the Act provides that a hospital 
may obtain a waiver of the above requirements from 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 comment in writing 
during the 60-day period beginning on the publication date in the 
Federal Register.
    Several hospitals have asked for and been granted waivers to work 
with a hospital other than the designated OPO. The statute does not 
expressly establish procedures for the situation where a hospital that 
had previously been granted a waiver, desires to enter into an 
agreement with a different OPO or return to work with the OPO that has 
been designated for the relevant geographic area. Given the importance 
of the hospital-OPO relationship for all potential transplant patients 
in the affected service areas, we are establishing an open and 
transparent process for addressing these situations. Specifically, 
using the same framework provided in section 1138(a)(2), the Secretary 
will enable hospitals that had been granted a waiver to apply to enter 
into an agreement with a different OPO. A specific notice will be 
published in the Federal Register within 30 days of the agency's 
receipt of such a request. We will provide the public an opportunity to 
submit information and material with respect to whether the proposed 
change would be expected to increase organ donation and would ensure 
the equitable treatment for transplant patients in both of the affected 
OPO service areas.

II. Request Procedures

    A hospital that has previously been granted a waiver under section 
1138(a)(2) but desiring to enter into an agreement with a different 
OPO, may file a request by submitting it to CMS at the following 
address: Director, Centers for Medicare and Medicaid Services, Division 
of Technical Payment Policy, 7500 Security Blvd, C4-25-02, Baltimore, 
MD 21244-1850.
    The letter should supply sufficient information and data to address 
how changing OPOs:
    1. Is expected to increase organ donation; and
    2. Will assure equitable treatment of patients referred for 
transplant within the existing OPO service area, within the service 
area of the OPO with which the hospital wishes to enter an agreement.
    In making a change in OPO determination, the Secretary may 
consider, among other factors:
    1. Cost effectiveness;
    2. Improvements in quality;
    3. Whether there has been a change in a hospital's service due to a 
change in definition of metropolitan statistical area (MSA); and
    4. The length and continuity of a hospital relationship with the 
OPO with which the hospital wants to align.
    Upon receipt of such a request, we would publish a Federal Register 
notice to solicit public comments, consistent with the procedures set 
forth in section 1138(a)(2)(D) of the Act.
    Under these procedures, we will review the request and comments 
received. During the review process, we may consult on an as-needed 
basis with the Health Resources 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 request and notify the hospital and the designated 
and requested OPOs.
    By providing an open and transparent public process with an 
opportunity to consider public comments, information and materials, the 
Secretary will be able to make better decisions concerning whether the 
proposed change in the OPO will be expected to increase organ donation 
and will assure equitable treatment for patients in both affected OPO 
service areas.

III. Collection of Information Requirements

    We anticipate receiving less than 10 hospital requests in a 12-
month period.

[[Page 33315]]

Therefore, in accordance with 5 CFR 1320.3(c), the reporting 
requirements in this notice are not defined as information collection 
requirements.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance, and Program No. 93.778, Medical 
Assistance Program)

    Dated: June 3, 2010.
Marilyn Tavenner,
Acting Administrator and Chief Operating Officer, Centers for Medicare 
& Medicaid Services.
[FR Doc. 2010-14098 Filed 6-10-10; 8:45 am]
BILLING CODE 4120-01-P