Opening the Donation Service Area (DSA) for Competition

2812.3 – Opening the Donation Service Area (DSA) for Competition from other OPOs (42 CFR 486.316) (Rev. 179, Issued: 07-06- 18, Effective: 07-06-18, Implantation: 07- 06-18) The CMS RO opens an OPO’s DSA for competition if: a. CMS terminates or de-certifies the OPO (involuntary termination) during the current certification period due to non-compliance with the Conditions for Coverage; b. The normal four year certification period has ended and CMS declines to renew its agreement with the OPO under §486.316 (non-renewal of an agreement); or c. An OPO ceases to operate or CMS has reasonable grounds for anticipating it will cease to operate (voluntary termination by the OPO). For a voluntary termination including a cessation of business, the RO opens the DSA for competition on the CMS-approved effective date of the termination. For an involuntary termination of an OPO or the non-renewal of an OPO’s agreement, the RO will open the area for competition either on the date of the completion of the administrative appeals process which upholds the termination action or once the time to file an appeal has passed and the OPO has declined to do so. A de-certified OPO cannot compete for its open area or any other open area. Simultaneously with opening the DSA for competition, the RO will request a transition plan from the non-renewed OPO that provides details on how all aspects of the OPO operation will be transmitted, including time frames, to a new OPO (see SOM Section 2812.4(a)-(l) below). The CMS RO will announce the opening of the DSA in an email to all currently certified OPOs and the Association of Organ Procurement Organizations. The following entities will be copied on the communication: • The CMS Center for Medicare; • The CMS Medicare Administrative Contractor for the non-renewed OPO (Form CMS-2007 Provider Tie-In Notice ) (required);and • The Health Resources and Services Administration (HRSA). The announcement will specify what information must be submitted by any OPO applicant, the deadline for submission of an application (which will be set at 45 calendar days from the date of the announcement), and the expected timeframe for selection of an applicant (which will generally be 30 calendar days from the application closing date). In the case of involuntary termination or non-renewal of an agreement, CMS may extend the agreement of the de-certified OPO to facilitate transition to a new OPO. In order to apply for an open DSA, an applicant OPO must meet the following criteria: a. Be in compliance with two out the three outcome measure requirements at 42 CFR 486.318; b. Be at or above 100 percent of the mean national rate averaged over the years of the re-certification cycle for the outcome measures at 42 CFR 486.318; c. Be at least 15 percentage points higher than the donation rate at 42 CFR 486.318 of the OPO currently designated for the service area; d. Be in compliance with the requirements for certification at 42 CFR 486.303, including the conditions for coverage at 42 CFR 486.320 through 42 CFR 486.348; and e. Compete for the entire service area.