Okla. Stat. tit. 36, § 36-6060.5a: Biomarker testing

A. As used in this section:

1. "Biomarker" means a biological molecule found in blood,

other body fluids, or tissues that is a sign of a normal or abnormal

process, or of a condition or disease. A biomarker may be used to

see how well the body responds to a treatment for a disease or

condition or for other purposes. Biomarkers shall include but are

not limited to gene mutation or protein expression;

2. "Biomarker testing" means the analysis of a patient’s

tissue, blood, or other biospecimen for the presence of a biomarker.

Biomarker testing shall include but not be limited to single-analyte

tests, multiplex panel tests, gene or protein expression, and whole

exome, whole genome, and whole transcriptome sequencing;

3. "Clinical utility" means the test result provides

information that is used in the formulation of a treatment or

monitoring strategy that informs a patient's outcome and impacts the

clinical decision. The most appropriate test may include both

information that is actionable and some information that cannot be

immediately used in the formulation of a clinical decision;

4. "Consensus statement" means a statement that:

a. is developed by an independent, multidisciplinary

panel of experts that use a transparent methodology

and reporting structure that includes a conflict of

interest policy,

b. is based on the best available evidence for the

purpose of optimizing clinical care outcomes, and

c. is aimed at specific clinical circumstances;

5. "Health benefit plan" means a plan as defined pursuant to

Section 6060.4 of Title 36 of the Oklahoma Statutes; and

6. "Nationally recognized clinical practice guidelines" means

evidence-based clinical practice guidelines that:

a. are developed by independent organizations or medical

professional societies using a transparent methodology

and reporting structure and a conflict of interest

policy, and

b. establish standards of care that are informed by a

systemic review of evidence and an assessment of the

benefits and costs of alternative care options that

includes recommendations intended to optimize patient

care.

B. Any health benefit plan, including the Oklahoma Employees

Insurance Plan, that is offered, issued, or renewed in this state on

or after the effective date of this act shall provide coverage for

biomarker testing. A contract provided with a health benefit plan

under this section shall include biomarker testing for the purpose

of diagnosis, treatment, appropriate management, or ongoing

monitoring of an insured’s disease or condition to guide treatment

decisions when the biomarker test provides clinical utility as

demonstrated by medical and scientific evidence including, but not

limited to:

1. Labeled indications for tests that are approved or cleared

by the United States Food and Drug Administration;

2. Indicated tests for a drug that is approved by the United

States Food and Drug Administration;

3. Warnings and precautions on United States Food and Drug

Administration-approved drug labels;

4. Centers for Medicare and Medicaid Services national coverage

determinations or Medicare administrative contractor local coverage

determinations; or

5. Nationally recognized clinical practice guidelines and

consensus statements.

C. A health benefit plan shall ensure that coverage is provided

in a manner that limits disruptions in care, including the need for

multiple biopsies and biospecimen samples.

D. An insured and a prescribing practitioner shall have access

to a clear, readily available, and convenient process to request an

exception to a coverage policy of a health benefit plan under this

subsection. The process shall be readily accessible on the plan’s

website. This subsection shall not be construed to require a

separate process if the health benefit plan’s existing process

complies with this subsection.