44-7,124.

Biomarker testing; covered by medical assistance program; when.

(1) The medical assistance program shall cover biomarker testing no later than January 1, 2028.

(2) Biomarker testing shall be covered when:

(a) The test is used for:

(i) The diagnosis, treatment, appropriate management, or ongoing monitoring of cancer, an autoimmune or autoinflammatory disease, Parkinson's disease, amyotrophic lateral sclerosis, Alzheimer's disease and related dementias, rheumatoid arthritis, preeclampsia, sickle cell anemia, or a cardiovascular condition;

(ii) An organ or tissue transplant; or

(iii) Pharmacogenomic testing; and

(b) The test provides clinical utility as demonstrated by medical and scientific evidence, including, but not limited to:

(i) Labeled indications for a test approved or cleared by the federal Food and Drug Administration;

(ii) Indicated tests for a drug approved by the federal Food and Drug Administration;

(iii) Warnings and precautions on drug labels approved by the federal Food and Drug Administration;

(iv) National coverage determinations by the federal Centers for Medicare and Medicaid Services or local coverage determinations by the medicare administrative contractor; or

(v) Nationally recognized clinical practice guidelines and consensus statements.

(3) Coverage, as specified in subsection (2) of this section, shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.

(4) Entities contracting with the medical assistance program to deliver services to program recipients shall provide biomarker testing at the same scope, duration, and frequency as the medical assistance program otherwise provides to recipients.

(5) The recipient and participating medical assistance program provider shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy of the medical assistance program. The process shall be made readily accessible on the Department of Health and Human Services' website.