RELATES TO:
KRS
205.520,
205.5605,
205.5606,
205.5607,
42 U.S.C.
1396d
NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and
Family Services, Department for Medicaid Services, has responsibility to
administer the Medicaid Program.
KRS
205.520(3) authorizes 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. 42 U.S.C.
1396d(gg) establishes
federal requirements for reimbursement relating to a qualifying clinical trial.
In keeping with that federal requirement, this administrative regulation
establishes the department's coverage and reimbursement for routine patient
costs relating to a qualifying clinical trial.
Section 1. Definitions.
(1) "Department" means the Department for
Medicaid Services or its designee.
(2) "Qualifying clinical trial" has the same
meaning as in 42 U.S.C.
1396d(gg)(2).
(3) "Routine patient costs" has the same
meaning as in 42 U.S.C.
1396d(gg)(1).
Section 2. Policy. Consistent with
42 U.S.C.
1396d(gg), services related
to qualifying clinical trials shall be reimbursable if:
(1) The services are covered services
pursuant to Title 907 KAR;
(2) The
services would otherwise be provided to a participant who is not participating
in a clinical trial; and
(3) The
services are not covered by the clinical trial sponsor.
Section 3. Qualifying Clinical Trial
Treatment Related Expenses.
(1) The department
shall comply with 42 U.S.C.
1396d and provide coverage for routine
patient costs associated with a qualifying clinical treatment.
(2) Any required coverage determination shall
be expedited and completed within seventy-two (72) hours.
(3) In complying with this section, the
provider shall not be:
(a) Required to provide
the geographic location or network affiliation of a provider associated with a
qualifying clinical trial and treating an enrolled Medicaid
recipient.
(b) Required to submit:
1. Protocols of the qualifying clinical
trial;
2. Proprietary
documentation; or
3. Any
information determined by the federal Health and Human Services cabinet to be
burdensome to provide.
(4)
(b) The form established in paragraph (a)
shall be submitted upon request and available for auditing purposes.
Section 4. Federal
Approval and Federal Financial Participation. The department's coverage and
reimbursement of services pursuant to this administrative regulation shall be
contingent upon:
(1) Receipt of federal
financial participation for the coverage and reimbursement; and
(2) Centers for Medicare and Medicaid
Services' approval of the coverage and reimbursement.
Section 5. Use of Electronic Signatures. The
creation, transmission, storage, or other use of electronic signatures and
documents shall comply with the requirements established in
KRS
369.101 to
369.120.
Section 6. Appeal Rights.
(1) An appeal of a department decision
regarding a Medicaid recipient based upon an application of this administrative
regulation shall be in accordance with
907 KAR 1:563.
(2) An appeal of a department decision
regarding Medicaid eligibility of an individual shall be in accordance with
907 KAR 1:560.
(3) An appeal of a department decision
regarding a Medicaid provider based upon an application of this administrative
regulation shall be in accordance with
907 KAR
1:671.
