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Statement of Need: This proposed rule contains new conditions for coverage for OPOs, including new performance standards. This proposed rule would also increase the rectification cycle for OPOs from two years to four years.

Summary of the Legal Basis: Section 1138(b) of the Social Security Act (the Act) provides the statutory qualifications and requirements that an OPO must meet in order to receive payment for organ procurement costs associated with procuring organs for hospitals under the Medicare and Medicaid programs. This section gives the Secretary broad authority to establish performance-related standards for OPOs. Under this authority, the Secretary established conditions for coverage for OPOs at 42 CFR 486.301, et seq. Section 1138(b) of the Act specifies that an OPO must be certified or rectified by the Secretary as meeting the standards to be a qualified OPO as described in section 371(b) of the Public Health Service (PHS) Act. The PHS Act requirements were established by the National Organ Transplant Act of 1984 and include provisions for OPO board membership, staffing, agreements with hospitals, and membership in the OPTN. The Organ Procurement Organization Certification Act of 2000 (section 701 of Pub. L. 106-505, 42 U.S.C. section 273(b)(1)(D)) amended section 371(b) of the PHS Act to require CMS to increase the certification cycle for OPOs from two years to four years and promulgate new performance standards for OPOs.

Alternatives: CMS is considering various alternatives in the development of performance measures and additional conditions for coverage, and will solicit public comments in order to identify additional alternatives.

Anticipated Costs and Benefits: While this rule is expected to improve OPO performance and organ donations, CMS is uncertain at this time about the rule's economic impact on OPOs.

Risks: Failure to publish new outcome performance standards would violate section 701 of Public Law 106-505, which amended the Public Health Service Act.