33-24-59.33. Required coverage for biomarker testing.

1. (a)

   As used in this Code section, the term:#

   1. (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. (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. (3)

      “Consensus statements” means statements developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict-ofinterest 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. (4)

      “Health benefit policy” means any individual or group plan, policy, or contract for healthcare services issued, delivered, issued for delivery, or renewed in this state which provides major medical benefits, including those contracts executed by the State of Georgia on behalf of state employees under Article 1 of Chapter 18 of Title 45, by a health care corporation, health maintenance organization, preferred provider organization, accident and sickness insurer, fraternal benefit society, hospital service corporation, medical service corporation, or other insurer or similar entity.#

   5. (5)

      “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-ofinterest 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.#

2. (b)

   All health benefit policies renewed or issued on or after July 1, 2023, shall include coverage for biomarker testing as provided in this Code section.#

3. (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. (1)

      A labeled indication for a test that has been approved or cleared by the United States Food and Drug Administration (FDA);#

   2. (2)

      An indicated test for an FDA approved drug;#

   3. (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. (4)

      Nationally recognized clinical practice guidelines and consensus statements; or#

   5. (5)

      Warnings and precautions on FDA approved drugs.#

4. (d)

   Health benefit policies shall ensure biomarker testing coverage is provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.#

5. (e)

   The insurer or similar entity subject to this Code section shall approve or deny a prior authorization request and notify the enrollee and the enrollee’s healthcare provider within seven calendar days for nonurgent requests or within 72 hours for urgent requests. If the insurer or similar entity fails to respond in accordance with such time frames, such request shall be deemed approved.#

6. (f)

   Enrollees, healthcare providers, and testing service providers shall have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy or an adverse utilization review determination under a health benefit policy, including, but not limited to, the rights of consumers under Article 2 of Chapter 20A of Title 33, the “Patient’s Right to Independent Review Act.” Such process shall be made readily accessible on the insurer’s or similar entity’s website.#

Reading note: a word broken across two lines in the printed volume was joined by rule and could not be checked against the volume's own vocabulary. The official page linked below settles any doubt.