2010-14098. 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.

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, [phone].

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 § 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. 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.