RELATES TO:
KRS 205.520, 42 C.F.R. 493,
42 U.S.C.
1396a -d
NECESSITY, FUNCTION, AND CONFORMITY: EO 2004-726, effective
July 9, 2004, reorganized the Cabinet for Health Services and placed the
Department for Medicaid Services and the Medicaid Program under the Cabinet for
Health and Family Services. The Cabinet for Health and Family Services has
responsibility to administer the program of medical assistance.
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 sets forth provisions relating to compliance by Medicaid providers
with requirements for certification for performance of laboratory testing and
implements the Clinical Laboratory Improvement Amendments of 1988.
Section 1. Definitions.
(1) "Certificate" means the appropriate
certificate of waiver, certificate of registration, or certificate of
accreditation issued by the United States Department of Health and Human
Services (HHS) which authorizes the performance of laboratory testing by a
provider of medical services.
(2)
"Medicaid provider" means a participating provider of medical services under
the Medicaid Program.
(3)
"State-exempt" means the state laboratory licensing program has been approved
by HHS.
Section 2.
Requirement for Certification. Any provider of laboratory testing services
participating in the Medicaid Program shall comply with certification
requirements specified in 42 CFR Part
493 unless the state's licensure program
has been approved by the HHS and the provider is appropriately licensed or
certified under the state-exempt licensing program.
Section 3. Issues Related to Certification
Requirements.
(1) A provider must have a
current, valid certificate in order to provide laboratory testing under the
Medicaid Program.
(2) A Medicaid
provider may perform Medicaid covered laboratory services for Medicaid eligible
individuals only to the extent authorized by the provider's
certificate.
(3) Any service not
covered by the Medicaid provider's certificate shall not be considered a
covered Medicaid service.
(4) Any
services not considered a covered Medicaid service shall not be paid for by the
Medicaid Program.
(5) Payments for
laboratory testing shall be made without proof of certification for the period
December 1, 1992 through December 31, 1992, with payments subject to recovery
if the provider does not subsequently receive and show proof of certification
for that period of time. Claims for laboratory testing performed after December
31, 1992, shall be denied unless the appropriate certification has been
obtained. If a request for certification is not made, is rejected, or when
approved does not cover the provision of the laboratory test(s) for which
payment has been made, the provider shall immediately refund all payments for
the noncovered laboratory service(s).
(6) The provisions of this administrative
regulation relate to covered laboratory testing which is otherwise provided for
by Medicaid administrative regulations.
Section 4. State-exempt Laboratory Licensing
Program.
(1) If the state has a state-exempt
laboratory licensing program, the requirements contained in this administrative
regulation shall apply with regard to certifications from the state's licensing
program.
(2) Providers licensed
under a state-exempt program are not required to obtain a certificate issued by
HHS.
Section 5. Effective
Date. The provisions of this administrative regulation shall be effective with
regard to services provided on or after December 1, 1992.
