5160-11-31. [Effective 1/1/2021] Independent diagnostic testing facility (IDTF) services

(A) Providers.

(1) An entity may enroll in medicaid as an independent diagnostic testing facility (IDTF) only if it meets the following criteria:

(a) It meets all standards set forth in and provide services in accordance with 42 C.F.R. 410.33 (October 1, 2020);

(b) It takes the following measures to establish accountability:

(i) It ensures that each supervising practitioner attests in writing, at the time of the initial application and at each renewal of the Ohio medicaid provider agreement, that one of two statements is true:

(a) The practitioner owns the facility, in whole or in part, and employs the operating personnel; or

(b) The practitioner works for the facility either as an employee (full-time or part-time) or under contract and has responsibilities that include checking the procedure and quality control manuals; observing the performance of operators or technicians; verifying that the equipment and personnel meet applicable conditions for federal, state, and local licensure and registration; and ensuring that safe operating procedures and quality control procedures are used;

(ii) It maintains and updates procedure and quality control manuals; and

(iii) It keeps all records of quality control must be kept for the period of time specified in rule 5160-1-17.2 of the Administrative Code; and

(c) It performs only procedures that are not subject to the "Clinical Laboratory Improvement Amendments of 1988" (CLIA, Pub. L. No. 100-578, 42 U.S.C. 263a as in effect on January 1, 2021).

(2) An entity that owns both an IDTF and an independent laboratory should enroll them as discrete Ohio medicaid providers.

(3) An entity may enroll in medicaid as a mammography supplier (a facility or an entity established solely for the provision of mammography services) only if it meets the following criteria:

(a) It participates in medicaid as an IDTF; and

(b) It complies with the conditions set forth in 42 C.F.R. 410.34 (October 1, 2020).

(B) Coverage. Provisions affecting payment for radiology services are set forth in rule 5160-4-25 of the Administrative Code.

(C) Claim payment.

(1) No separate payment is made to an IDTF that performs a procedure in a hospital setting. Instead, the provider makes payment arrangements directly with the participating hospital.

(2) For a covered global radiology procedure and its professional and technical components, the medicaid maximum payment amounts are indicated in appendix DD to rule 5160-1-60 of the Administrative Code.

Replaces: 5160-11- 03.3, part of 5160-11-01, part of 5160-11-02, part of 5160-11-09

Effective: 1/1/2021
Five Year Review (FYR) Dates: 01/01/2026
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/07/1977, 09/19/1977, 12/21/1977, 12/30/1977, 06/03/1983, 10/01/1983 (Emer.), 12/29/1983, 10/01/1984, 10/01/1984 (Emer.), 12/30/1984, 01/01/1986, 05/09/1986, 06/01/1986, 06/16/1988, 01/13/1989 (Emer.), 04/13/1989, 09/01/1989, 02/17/1991, 04/01/1992 (Emer.), 07/01/1992, 09/02/1992 (Emer.), 12/01/1992, 04/30/1993 (Emer.), 07/01/1993, 12/30/1993 (Emer.), 03/31/1994, 12/29/1995 (Emer.), 02/01/1996 (Emer.), 03/21/1996, 04/04/1996, 12/31/1997 (Emer.), 03/19/1998, 12/31/1998 (Emer.), 03/31/1999, 08/01/2001, 02/01/2003, 04/01/2004, 12/30/2005 (Emer.), 03/27/2006, 05/05/2006, 12/31/2007 (Emer.), 03/30/2008, 06/01/2009, 04/01/2016, 01/01/2018