907 KAR 1:350. Coverage and payments for organ transplants.


      RELATES TO: KRS 205.520, 42 C.F.R. 447.53

      STATUTORY AUTHORITY: 194A.030(2), 194A.050(1), 205.520(3)

      NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and Family Services has responsibility to administer the Medicaid Program. KRS 205.520(3) empowers the cabinet, by administrative regulation, to comply with any requirement that may be imposed, or opportunity presented, by federal law for the provision of medical assistance to Kentucky's indigent citizenry. This administrative regulation establishes provisions related to the coverage of organ transplants.


      Section 1. Definitions. (1) "Department" means the Department for Medicaid Services or its designee.

      (2) "Emergency" means that a condition or situation requires an emergency service pursuant to 42 C.F.R. 447.53.

      (3) "Experimental" means that a procedure has not previously been proven effective by the U.S. Food and Drug Administration in treating a patient's health condition.

      (4) "Medical necessity" or "medically necessary" means that a covered benefit is determined to be needed in accordance with 907 KAR 3:130.

      (5) "Nonemergency" means that a condition or situation does not require an emergency service pursuant to 42 C.F.R. 447.53.


      Section 2. Prior Authorization. (1) Prior to coverage of an organ transplant, the transplant shall be determined by the department to be:

      (a) Medically necessary; and

      (b) Clinically appropriate pursuant to the criteria established in 907 KAR 3:130.

      (2) The requirements established in subsection (1) of this section shall not apply to an emergency service.


      Section 3. General Coverage Criteria. A covered organ transplant shall meet the following criteria:

      (1) A transplant surgeon's opinion shall conclude that failure to perform the transplant would create a life-threatening situation;

      (2) The patient's prognosis shall indicate that there is a reasonable expectation the transplant will be successful and result in prolonged life of quality and dignity;

      (3) The hospital where the transplant will take place shall:

      (a) Have a staffed and functioning unit designed for and accustomed to performing the planned organ transplant;

      (b) Be accredited by the Joint Commission on Accreditation of Healthcare Organizations; and

      (c) Be in good standing:

      1. If it is an in-state hospital, with the Cabinet for Health and Family Services; or

      2. If it is an out-of-state hospital, with that state's licensure authority; and

      (4) The physician performing the transplant shall be recognized as competent by the medical community.


      Section 4. Reimbursement for Organ Transplants. (1) Payment to a hospital for an organ transplant shall be set at eighty (80) percent of the hospital's usual and customary charge with total payments not to exceed $75,000 per transplant.

      (2) If the payment methodology established in subsection (1) of this section restricts or prohibits the availability of a needed transplant procedure or service, the department's commissioner may approve on a case-by-case basis payment that exceeds $75,000 per transplant.

      (3) Reimbursement to a physician for an organ transplant shall be made in accordance with the Medicaid Physician Fee Schedule established in 907 KAR 3:010.


      Section 5. Noncovered Services. The department shall not approve a request for an organ transplant if the requested transplant:

      (1) Fails to meet the criteria of Sections 2 or 3 of this administrative regulation; or

      (2) Is experimental in nature. (13 Ky.R. 1520; eff. 3-6-87; Am. 15 Ky.R. 2462; eff. 8-5-89; 33 Ky.R. 600; 1563; eff. 1-5-2007.)