Sponsored by:
Senator VIN GOPAL
District 11 (Monmouth)
Senator TROY SINGLETON
District 7 (Burlington)
Co-Sponsored by:
Senators A.M.Bucco, Johnson, Greenstein, Pennacchio, Diegnan, McKnight, Beach and Cruz-Perez
SYNOPSIS
Requires health insurers to provide coverage for biomarker testing.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning health insurance coverage for biomarker testing and amending and supplementing various parts of the statutory law.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. Each hospital service corporation contract that provides hospital or medical expense benefits and is delivered, issued, executed, or renewed in this State pursuant to P.L.1938, c.366 (C.17:48-1 et seq.) or is approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill), shall provide coverage for biomarker testing, as defined by subsection g. of this section.
b. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition of a subscriber when the test is supported by medical and scientific evidence, including, but not limited to:
(1) labeled indications for an FDA-approved or FDA-cleared test;
(2) indicated tests for an FDA-approved drug;
(3) warnings and precautions on FDA-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. Coverage, pursuant to subsection b. of this section, shall be provided in a manner that limits disruption, including multiple biopsies or biospecimen samples, in the care of a subscriber.
d. (1) Notwithstanding any other law, rule, or regulation to the contrary, if utilization review is required, a decision shall be rendered on a prior authorization request, and notice shall be sent to the subscriber and the appropriate health care provider, and if the request is made through a health care entity, to the health care entity, within 72 hours for a non-urgent request or 24 hours for an urgent request.
(2) The subscriber and the treating health care provider or treating health care entity prescribing biomarker testing for the subscriber shall have access to clear, readily accessible, and conspicuous information on the process to submit an appeal to an adverse determination.
e. The benefits shall be provided to the same extent as for any other medical condition under the contract.
f. The provisions of this section shall apply to all hospital service corporation contracts in which the hospital service corporation has reserved the right to change the premium.
g. As used in this section:
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, including known gene-drug interactions for medications being considered for use or already being administered. Biomarkers shall also include, but not be limited to, gene mutations, characteristics of genes, or protein expression.
Biomarker testing means the analysis of tissue, blood, or other biospecimen for the presence of a biomarker. Biomarker testing includes but is not limited to, single-analyte tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.
Consensus statement means a statement developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict of interest policy. The statement shall be aimed at specific clinical circumstances and be based on the best available evidence for the purpose of optimizing the outcomes of clinical care.
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. The 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. a. Each medical service corporation contract that provides hospital or medical expense benefits and is delivered, issued, executed, or renewed in this State pursuant to P.L.1940, c.74 (C.17:48A-1 et seq.) or is approved for issuance or renewal in this State by the Commissioner of Banking and Insurance, on or after the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill), shall provide coverage for biomarker testing, as defined by subsection g. of this section.
b. Biomarker testing shall be covered for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition of a subscriber when the test is supported by medical and scientific evidence, including, but not limited to:
(1) labeled indications for an FDA-approved or -cleared test;
(2) indicated