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Proposed Recommendation

Proposed Recommendation.

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Proposed Recommendation

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  1. Proposed Recommendation • Due to the misalignment and inconsistencies between CMS certification regulations and outcomes requirements for transplant centers (TCs) and organ procurement organizations (OPOs), the ACOT recommends that the Secretary direct CMS to confer with HRSA, OPTN, SRTR, the OPO community, and transplant center representatives to determine appropriate requirements for OPOs and TCs that unify mutual goals of increasing organ donation, improving recipient outcomes and reducing organ wastage. The report will include, but is not limited to, improved risk-adjustment methodologies for TCs and a statistically sound method for yield measure for OPOs.

  2. Revised Recommendation • The ACOT recognizes that the current CMS and HRSA/OPTN structure creates unnecessary burdens and inconsistent requirements on transplant centers (TCs) and organ procurement organizations (OPOs) and that the current system lacks responsiveness to advances in TC and OPO performance metrics. The ACOT recommends that the Secretary direct CMS and HRSA to confer with the OPTN, SRTR, the OPO community, and TC representatives, to conduct a comprehensive review of regulatory and other requirements, and to promulgate regulatory and policy changes to requirements for OPOs and TCs that unify mutual goals of increasing organ donation, improving recipient outcomes, and reducing organ wastage and administrative burden on TCs and OPOs. These revisions should include, but not be limited to, improved risk adjustment methodologies for TCs and a statistically sound method for yield measures for OPOs. The ACOT recommends that this review be completed within one year and that action be taken within two years.

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