§ 486.316 - Re-certification and competition processes.

§ 486.316 Re-certification and competition processes.

Cross Reference

Link to an amendment published at 85 FR 77947, Dec. 2, 2020.

Cross Reference

This amendment is delayed until March 30, 2021, at 86 FR 7813, Feb. 2, 2021.

(a) Re-Certification of OPOs(a) Re-certification of OPOs. Based upon performance on the outcome measures set forth in § 486.318 and the re-certification survey, each OPO will be designated into either Tier 1, Tier 2, or Tier 3. The tier in which the OPO is designated will determine whether the OPO is re-certified (Tier 1), must compete to retain its DSA (Tier 2), or will receive an initial de-certification determination (Tier 3).

(1) Tier 1. An OPO is re-certified for at least an additional 4 years

and its service area

, the OPO's DSA is not opened for competition

when the OPO:

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

(2) Has

, and the OPO can compete for any open DSA if it meets all of the following:

(i) It 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

360; and

(ii) It meets the outcome requirements as described in § 486.318(

a

e)(

1) and (3) for OPOs not operating exclusively in the noncontiguous States, Commonwealths, Territories, or possessions; or

4) for the final assessment period of the agreement cycle.

(2) Tier 2. An OPO's DSA is open for competition and the OPO is eligible to compete to retain its DSA and for any open DSA if it meets all of the following:

(i) It 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 486.360; and

(ii) It meets the outcome requirements as described in § 486.318(

b

e)(

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

5) at the final assessment period of the agreement cycle.

(3) Tier 3. An OPO will receive a notice of de-certification determination under § 486.314 and cannot compete for any open DSA if it meets either of the following:

(i) Has been shown by survey to not be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360; or

(ii) Has outcome requirements as described in § 486.318(

a

e)(

2) or (b)(2) for the 2022 recertification

6) at the final assessment period of the agreement 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

fails to meet the outcome measures set forth in § 486.318(e)(6) at the final assessment period prior to the end of the agreement cycle, or it meets the requirements described in paragraph (a)(

2

3) of this section

,

:

(1) CMS will send the OPO is de-certified. a notice of its initial de-certification determination and the OPO has the right to appeal as established in § 486.314;

(2) 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

that qualify 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. service areas as set forth in paragraph (c) of this section. The de-certified OPO is not permitted to compete for its open area or any other open area. An

(3) The OPO competing for

an

the 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 areaDSA, 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)

performance requirements of the outcome measures for Tier 1 or Tier 2 at § 486.318(e)(4) and (5), and the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360 at the most recent routine survey. The OPO must compete for the entire

service area

DSA.

(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.

(f) Extension of the agreement cycle for extraordinary circumstances. OPOs can seek a 1-year extension of the agreement cycle if there are extraordinary circumstances beyond the control of the OPOs that has affected the data of the final assessment period so that it does not accurately capture their performance. OPOs must request this extension within 90 days of the end of the occurrence of the extraordinary circumstance but no later than the last day of the final assessment period.

(g) Exception. 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. 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 has been shown by survey to not be in compliance with the requirements for certification at § 486.303, including the conditions for coverage at §§ 486.320 through 486.360, 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.

[71 FR 31046, May 31, 2006, as amended at 78 FR 75199, Dec. 10, 2013; 84 FR 61492, Nov. 12, 2019; 85 FR 77947, Dec. 2, 2020]