(1) The medicaid agency measures the effectiveness of transplant centers of excellence (COE) using the performance criteria in this section. Unless otherwise waived by the agency, the agency applies these criteria to a hospital during both initial and periodic evaluations for designation as a transplant COE. The COE performance criteria must include, but not be limited to:
(a) Meeting annual volume requirements for the specific transplant procedures for which approved;
(b) Patient survival rates; and
(c) Relative cost per case.
(2) A transplant COE must meet or exceed annually the following applicable volume criteria for the particular transplant procedures performed at the facility, except for cornea transplants which do not have established minimum volume requirements. Annual volume requirements for transplant centers of excellence include:
(a) Twelve or more heart transplants;
(b) Ten or more lung transplants;
(c) Ten or more heart-lung transplants;
(d) Twelve or more liver transplants;
(e) Twenty-five or more kidney transplants;
(f) Eighteen or more pancreas transplants;
(g) Eighteen or more kidney-pancreas transplants;
(h) Ten or more bone marrow transplants; and
(i) Ten or more peripheral stem cell (PSC) transplants.
Dual-organ procedures may be counted once under each organ and the combined procedure.
(3) A transplant hospital within the state that fails to meet the volume requirements in subsection (1) of this section may submit a written request to the agency for conditional approval as a transplant COE. The agency considers the minimum volume requirement met when the requestor submits an approved certificate of need for transplant services from the department of health (DOH).
(4) An in-state hospital granted conditional approval by the agency as a transplant COE must meet the agency's criteria, as established in this chapter, within one year of the conditional approval. The agency must automatically revoke such conditional approval for any hospital that fails to meet the agency's published criteria within the allotted one year period, unless:
(a) The hospital submits a written request for extension of the conditional approval thirty calendar days before the expiration date; and
(b) The request is granted by the agency.
(5) A transplant center of excellence must meet medicare's survival rate requirements for the transplant procedures performed at the hospital.
(6) A transplant COE must submit to the agency annually, at the same time the hospital submits a copy of its medicare cost report (Form 2552-96) documentation showing:
(a) The numbers of transplants performed at the hospital during its preceding fiscal year, by type of procedure; and
(b) Survival rates data for procedures performed over the preceding three years as reported on the United Network of Organ Sharing report form.
(7) Transplant hospitals must:
(a) Submit to the agency, within sixty days of the date of the hospital's approval as a COE, a complete set of the comprehensive patient selection criteria and treatment protocols used by the hospital for each transplant procedure it has been approved to perform.
(b) Submit to the agency annual updates to the documents listed in (a) of this subsection, or when the hospital makes a change to the criteria or protocols.
(c) Notify the agency if no changes occurred during a reporting period.
(8) The agency evaluates compliance with the provisions of WAC 182-550-2100
(3) based on the protocols and criteria submitted to the agency by a transplant COE under subsection (7) of this section. The agency terminates a hospital's designation as a transplant COE if a review or audit finds that hospital in noncompliance with:
(a) Its protocols and criteria in evaluating and selecting candidates for transplantation; and
(b) Distributing donated organs in a fair and equitable manner that promotes an optimal or successful patient outcome.
(9) The agency:
(a) Provides notification to a transplant COE it finds in noncompliance with subsection (8) of this section, and may allow from the date of notification sixty days within which such centers may submit a plan to correct a breach of compliance;
(b) Does not allow the sixty-day option as stated in (a) of this subsection for a breach that constitutes a danger to the health and safety of clients as stated in WAC 182-502-0030
(c) Requires, within six months of submitting a plan to correct a breach of compliance, a center to report that:
(i) The breach of compliance has been corrected; or
(ii) Measurable and significant improvement toward correcting the breach of compliance exists.
(10) The agency periodically reviews the list of approved transplant COEs. The agency may limit the number of hospitals it designates as a transplant COE or contracts with to provide services to Washington apple health clients if, in the agency's opinion, doing so would promote better client outcomes and cost efficiencies.
(11) The agency pays an agency-approved COE for covered transplant procedures using methods identified in chapter 182-550
[Statutory Authority: RCW 41.05.021
. WSR 15-18-065, § 182-550-2200, filed 8/27/15, effective 9/27/15. WSR 11-14-075, recodified as § 182-550-2200, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090
. WSR 07-14-018, § 388-550-2200, filed 6/22/07, effective 8/1/07. Statutory Authority: RCW 74.08.090
. WSR 01-02-075, § 388-550-2200, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 74.08.090
, [74.09.]500, [74.09.]530 and 43.20B.020
. WSR 98-01-124, § 388-550-2200, filed 12/18/97, effective 1/18/98.]