Sec. 10.14.02.12. Medical Laboratory Services

A. To be considered a participating medical laboratory in the Program, the provider shall:

(1) Be in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to:

(a) Requirements for Medicare certification;

(b) Compliance with the requirements pursuant to COMAR 10.10.03.01 if operating in Maryland; and

(c) Requirements for the Federal Clinical Laboratory Improvement Act of 1988, 42 U.S.C. §263a;

(2) Agree to accept as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount;

(3) Agree not to bill an eligible patient for an additional charge for the medical laboratory services provided;

(4) Abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form;

(5) Place no restriction on the eligible patient's right to select a provider; and

(6) Maintain records adequate to substantiate the ordering, performance, and reporting of laboratory procedures performed or referred for a minimum of 6 years, and, upon request, allow the Department access to the records.

B. A reimbursed service includes but is not limited to the following:

(1) Preparation, analysis, and interpretation of a cervical biopsy, endometrial biopsy, vaginal biopsy, and breast biopsy; and

(2) A laboratory procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion.

C. A non-reimbursed service includes but is not limited to the following:

(1) A laboratory service not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion;

(2) A service for which there does not exist an order signed by a participating health care provider;

(3) A procedure for which the laboratory has not been certified by Medicare;

(4) A service not provided according to the laws and regulations of the jurisdiction in which the service is rendered;

(5) A procedure that is investigational or experimental in nature; and

(6) A service included and paid for by the Program as part of the total charge submitted by an inpatient facility or hospital outpatient department.

D. Reimbursement Procedures. The participating medical laboratory is responsible for:

(1) Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service as follows:

(a) If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating medical laboratory shall send the bill to the Department; or

(b) If an eligible patient is covered by Medicare or other insurance, the participating medical laboratory shall bill:

(i) Medicare or the other insurance for the service; and

(ii) The Department for the outstanding deductible and patient contribution amount; and

(2) Keeping in the records, for each invoice, a copy of the signed orders from a participating health care provider requesting the service.

E. Payment Procedures.

(1) The Department shall pay the participating medical laboratory for a reimbursed service:

(a) Pursuant to COMAR 10.09.09.07E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; or

(b) Pursuant to COMAR 10.09.09.07F and G(1) and 100 percent of co-insurance for an approved procedure for an eligible patient who is covered by Medicare.

(2) The Department may not reimburse for:

(a) Completion of a form or report;

(b) A broken or missed appointment; and

(c) A service which is normally provided at no charge.

F. The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter.