2023 CODE OF GEORGIA › Title 49 - SOCIAL SERVICES (§§ 49-1-1 — 49-10-7) › Chapter 4 - PUBLIC ASSISTANCE (§§ 49-4-1 — 49-4-193) › Article 7 - MEDICAL ASSISTANCE GENERALLY (§§ 49-4-140 — 49-4-159.3) › Section 49-4-159.3 - Biomarker testing for Medicaid recipients

(a)
As used in this Code section, the term:
(1)
"Biomarker" means a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. Such term includes, but is not limited to, gene mutations, protein expression, known gene-drug interactions for medications, and characteristics of genes.
(2)
"Biomarker testing" means the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker. Such term includes, but is not limited to, single-analyte tests, multiplex panel tests, whole genome sequencing, protein expression, whole exome, and whole transcriptome.
(3)
"Consensus statements" means statements developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict-of-interest policy. Such statements are aimed at specific clinical circumstances and base the statements on the best available evidence for the purpose of optimizing the outcomes of clinical care.
(4)
"Nationally recognized clinical practice guidelines" means evidence based clinical practice guidelines developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict-of-interest policy. Such guidelines establish standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care.
(b)
The department shall provide biomarker testing for Medicaid recipients in accordance with the requirements of this Code section.
(c)
Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an enrollee's disease or condition when the testing is supported by medical and scientific evidence, including, but not limited to:
(1)
A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA);
(2)
An indicated test for an FDA approved drug;
(3)
A national coverage determination made by the federal Centers for Medicare and Medicaid Services or a local coverage determination made by a medicare administrative contractor;
(4)
Nationally recognized clinical practice guidelines and consensus statements; or
(5)
Warnings and precautions on FDA approved drugs.
(d)
Care management organizations shall provide biomarker testing as required by this Code section at the same scope, duration, and frequency as the Medicaid program otherwise provides to recipients of medical assistance.
(e)
A care management organization or its agent shall approve or deny a prior authorization request and notify the recipient and the provider of medical assistance within seven calendar days for nonurgent requests or within 72 hours for urgent requests. If the care management organization or its agent fails to respond in accordance with such time frames, such request shall be deemed approved.
(f)
Recipients of medical assistance, providers of medical assistance, and testing service providers shall be afforded the fair hearing rights provided pursuant to Code Section
49-4-153
or the state plan provided for in Article 13 of Chapter 5 of Title 49 to request an exception to a coverage policy or an adverse utilization review determination by a care management organization or its agent. Such hearing rights shall be made readily accessible on the department's and care management organization's websites.
Added by 2023 Ga. Laws 232,§ 2, eff. 7/1/2023.
Code Section 49-4-159.2, as enacted by Ga. L. 2023, p. HB 85, § 2/HB 85, was redesignated as Code Section 49-4-159.3.