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Electronic Code of Federal Regulations

e-CFR data is current as of February 14, 2020

Title 42Chapter IVSubchapter GPart 486Subpart G → §486.316


Title 42: Public Health
PART 486—CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS
Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations


§486.316   Re-certification and competition processes.

(a) Re-Certification of OPOs. An OPO is re-certified for an additional 4 years and its service area is not opened for competition when the OPO:

(1) Meets two out of the three outcome measures requirements at §486.318; and

(2) Has been shown by survey to be in compliance with the requirements for certification at §486.303, including the conditions for coverage at §§486.320 through 486.348.

(3) For the 2022 recertification cycle only, an OPO is recertified for an additional 4 years and its service area is not opened for competition when the OPO meets one out of the two outcome measure requirements described in §486.318(a)(1) and (3) for OPOs not operating exclusively in the noncontiguous States, Commonwealths, Territories, or possessions; or §486.318(b)(1) and (3) for OPOs operating exclusively in noncontiguous States, Commonwealths, Territories, and possessions. An OPO is not required to meet the second outcome measure described in §486.318(a)(2) or (b)(2) for the 2022 recertification cycle.

(b) De-certification and competition. (1) If an OPO does not meet two out of the three outcome measures as described in paragraph (a)(1) of this section or the requirements described in paragraph (a)(2) of this section, the OPO is de-certified. If the OPO does not appeal or the OPO appeals and the reconsideration official and CMS hearing officer uphold the de-certification, the OPO's service area is opened for competition from other OPOs. The de-certified OPO is not permitted to compete for its open area or any other open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.

(2) For the 2022 recertification cycle only, if an OPO does not meet one of the outcome measures as described in paragraphs §486.318(a)(1), (a)(3), (b)(1), or (b)(3), or the requirements described in paragraph (a)(2) of this section, the OPO is de-certified. If the OPO does not appeal or the OPO appeals and the reconsideration official and CMS hearing officer uphold the de-certification, the OPO's service area is opened for competition from other OPOs. The de-certified OPO is not permitted to compete for its open area or any other open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.

(c) Criteria to compete. To compete for an open service area, an OPO must meet the criteria in paragraph (a) of this section and the following additional criteria:

(1) The OPO's performance on the donation rate outcome measure and yield outcome measure is at or above 100 percent of the mean national rate averaged over the 4 years of the re-certification cycle; and

(2) The OPO's donation rate is at least 15 percentage points higher than the donation rate of the OPO currently designated for the service area.

(3) The OPO must compete for the entire service area.

(d) Criteria for selection. CMS will designate an OPO for an open service area based on the following criteria:

(1) Performance on the outcome measures at §486.318;

(2) Relative success in meeting the process performance measures and other conditions at §§486.320 through 486.348;

(3) Contiguity to the open service area.

(4) Success in identifying and overcoming barriers to donation within its own service area and the relevance of those barriers to barriers in the open area. An OPO competing for an open service area must submit information and data that describe the barriers in its service area, how they affected organ donation, what steps the OPO took to overcome them, and the results.

(e) No OPO applies. If no OPO applies to compete for a de-certified OPO's open area, CMS may select a single OPO to take over the entire open area or may adjust the service area boundaries of two or more contiguous OPOs to incorporate the open area. CMS will make its decision based on the criteria in paragraph (d) of this section.

[71 FR 31046, May 31, 2006, as amended at 78 FR 75199, Dec. 10, 2013; 84 FR 61492, Nov. 12, 2019]

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