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),
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 to qualify for federal Medicaid funds. This administrative
regulation establishes provisions related to Medicaid Program coverage of organ
transplants for Medicaid recipients and related to Department for Medicaid
Services’ reimbursement regarding organ transplants provided to Medicaid recipients
who are not enrolled with a managed care organization.
Section 1. Definitions. (1)
"Department" means the Department for Medicaid Services or its
(2) "Emergency" means that a
condition or situation requires an emergency service pursuant to 42 C.F.R. 438.114(a).
(3) "Enrollee" means a
recipient who is enrolled with a managed care organization.
(4) "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.
(5) "Managed care organization"
means an entity for which the Department for Medicaid Services has contracted
to serve as a managed care organization as defined in 42 C.F.R. 438.2.
(6) "Medical necessity" or
"medically necessary" means that a covered benefit is determined to
be needed in accordance with 907 KAR 3:130.
(7) "Nonemergency" means that a
condition or situation does not require an emergency service pursuant to 42
(8) "Recipient" is defined by KRS
Section 2. Prior Authorization. (1) Prior
to coverage of an organ transplant to a recipient who is not an enrollee, the
transplant shall have been 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 criteria established in this section. (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.
(4) The physician performing the transplant
shall be recognized as competent by the medical community.
Section 4. Reimbursement for Organ
Transplants. For an organ transplant provided by a:
(1) Hospital to a recipient who is not an
enrollee, the department shall reimburse as established in:
(a) 907 KAR 10:825 through September 30,
(b) 907 KAR 10:830 effective October 1,
(2) Physician to a recipient who is not
an enrollee, the department shall reimburse in accordance with 907 KAR 3:010.
Section 5. Noncovered Services. The
department shall not approve a request for an organ transplant if the requested
(1) Fails to meet the criteria of Sections
2 or 3 of this administrative regulation; or
(2) Is experimental in nature.
Section 6. Not Applicable to Managed Care
Organizations. A managed care organization shall not be required to reimburse for
an organ transplant according to this administrative regulation. (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; 40 Ky.R. 1488;
2298; eff. 5-2-2014; 41 Ky.R. 2136; 2559; eff. 7-6-2015.)