This section applies to requirements for facilities that perform the medicaid agency-approved transplants described in WAC 182-550-1900(2).

1. (1) The agency requires instate transplant facilities to meet the following requirements to be paid for transplant services provided to Washington apple health clients. A facility must have:

   1. (a) An approved certificate of need (CON) from the state department of health (DOH) for the type of transplant procedure to be performed; and
   2. (b) Approval as a medicare-certified transplant facility.
   3. (c) The agency does not require medicare or department of health approval as a transplant facility for a facility that provides stem cell, skin graft, or corneal transplant services.
2. (2) The agency requires an out-of-state transplant facility, including bordering city and critical border facilities, to be a medicare-certified transplant facility and participating in that state's medicaid program. All out-of-state transplant services must be prior authorized.

3. (3) The agency applies the following specific requirements to a stem cell transplant facility:

   1. (a) A stem cell transplant facility must be in compliance with 21 C.F.R. § 1271 to perform any of the following stem cell services:

      1. (i) Harvesting, if it has its own apheresis equipment which meets federal or American Association of Blood Banks (AABB) requirements;
      2. (ii) Processing, if it meets AABB quality of care requirements for human tissue/tissue banking; and
      3. (iii) Reinfusion, if it meets the criteria established by the Foundation for the Accreditation of Cellular Therapy.
   2. (b) A stem cell transplant facility may purchase stem cell processing and harvesting services from other agency-approved processing providers.
4. (4) The agency does not pay a stem cell transplant facility for AABB inspection and certification fees related to stem cell transplant services.
5. (5) The agency does not pay for any service that requires consent under RCW 18.130.420.

[Statutory Authority: RCW 41.05.021 and 41.05.160. WSR 25-01-096, s 182-550-2100, filed 12/13/24, effective 1/13/25; WSR 15-18-065, § 182-550-2100, filed 8/27/15, effective 9/27/15. WSR 11-14-075, recodified as § 182-550-2100, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090, 74.09.500. WSR 07-14-018, § 388-550-2100, filed 6/22/07, effective 8/1/07. Statutory Authority: RCW 74.08.090, 74.09.730, 74.04.050, 70.01.010, 74.09.200, [74.09.]500, [74.09.]530 and 43.20B.020. WSR 98-01-124, § 388-550-2100, filed 12/18/97, effective 1/18/98.]