5101:3-11-04 Laboratory: exceptions for FQHCs, RHCs, OHFs, and hospital outpatients.

(A) Definitions.

For the purpose of this rule:

(1) "Facility" means any federally qualified health center (FQHC), rural health center (RHC), or outpatient health facility (OHF) that has signed an Ohio medicaid "provider agreement."

(2) A facility shall be considered "related to" another facility if one facility owns the other facility or the two facilities are owned by the same (separate) entity.

(3) A "hospital provider" is a hospital eligible for participation in the medicaid program in accordance with rule 5101:3-2-01 of the administrative code.

(4) "Clinical Laboratory Improvement Amendment" (CLIA) sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens.

(B) FQHCs, RHCs, OHFs or the combination of any of the three may bill for laboratory procedures they do not actually perform if:

(1) The procedures were referred to and performed by a facility that is related to the referring FQHC, RHC, or OHF.

(2) The (reference) facility that actually performed the procedures is certified to perform the service under the clinical laboratory improvement amendments (CLIA).

(3) The referring facility discloses, in writing to the department, the following information:

(a) The name, address, and CLIA number of the reference facility;

(b) Information on the ownership of and/or relationship between the referring facility and the reference facility; and

(c) A list of the laboratory procedures referred to the reference facility.

(4) The referring facility must notify the department in writing of any changes made to the disclosure information specified in paragraph (B)(3) of this rule.

(5) The department will exclude from the cost reports any costs allocated for laboratory procedures performed by facilities or laboratories that are not certified to perform the procedures under CLIA.

(C) For hospital outpatients, hospital providers may bill for clinical laboratory procedures they do not actually perform, when the procedures are referred to and performed by a laboratory that is certified to perform the service under the CLIA.

(a) When clinical laboratory services for hospital outpatients are performed by a reference laboratory, the referring hospital provider must have a written arrangement with the reference laboratory that specifies which provider will bill the department for the laboratory services. If the hospital provider bills for a clinical laboratory service performed by a reference laboratory, the reference laboratory must not bill either medicaid or the beneficiary for its service. If the reference laboratory bills for the clinical laboratory service, the referring hospital must not bill either medicaid or the beneficiary for the service.

(b) In the event that the department issues payment to both the referring hospital and the reference laboratory for the same clinical laboratory service, the department will make the assumption that the payment issued to the reference laboratory is subject to recovery.

Effective: 05/25/2006
R.C. 119.032 review dates: 03/09/2006 and 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 2/7/91, 9/2/92 (Emer), 12/1/92, 12/31/98 (Emer), 3/31/99