STATE OF NEW JERSEY
220th LEGISLATURE
PRE-FILED FOR INTRODUCTION IN THE 2022 SESSION
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
Assemblyman DANIEL R. BENSON
District 14 (Mercer and Middlesex)
Assemblyman ANTHONY S. VERRELLI
District 15 (Hunterdon and Mercer)
Co-Sponsored by:
Assemblywomen Chaparro, Murphy, Swain, Assemblyman Tully, Assemblywoman Speight, Assemblymen Mejia, Danielsen, Karabinchak, Assemblywomen Timberlake, Quijano, Lampitt, Jimenez, McKnight, Lopez, N.Munoz, Assemblyman McKeon, Assemblywomen Tucker, Reynolds-Jackson, Dunn, Assemblymen Stanley, Sauickie, Clifton, Assemblywomen Haider, Swift, Assemblyman DeAngelo, Assemblywoman Carter, Assemblymen Bergen, Guardian, Assemblywomen Piperno, Eulner and Assemblyman Moriarty
SYNOPSIS
Establishes certain guidelines for health insurance carriers concerning step therapy protocols.
CURRENT VERSION OF TEXT
Introduced Pending Technical Review by Legislative Counsel.
An Act concerning health insurance and supplementing Title 26 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. The Legislature finds and declares that:
a. Health insurance plans are increasing the use of step therapy protocols that require patients to try one or more prescription drugs before coverage is provided for a drug selected by the patients health care provider.
b. Step therapy protocols, if based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients, can play an important role in controlling health care costs.
c. In some cases, requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who may either not realize a benefit from taking a prescription drug or may suffer harm from taking an inappropriate drug.
d. Without uniform policies in the State for step therapy protocols, all patients may not receive the equivalent or most appropriate treatment.
e. It is imperative that step therapy protocols in the State preserve the heath care providers right to make treatment decisions in the best interest of the patient.
f. The Legislature declares, therefore, that it is a matter of public interest that health insurance carriers be required to base step therapy protocols on appropriate clinical practice guidelines or published peer-reviewed data developed by independent experts with knowledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when those protocols are inappropriate or otherwise not in the best interest of the patients; and that patients have access to a fair, transparent and independent process for requesting an exception to a step therapy protocol when the patients physician deems appropriate.
2. As used in this act:
"Carrier" means an insurance company, health service corporation, hospital service corporation, medical service corporation, or health maintenance organization authorized to issue health benefits plans in this State.
Clinical practice guidelines means a systematically developed statement to assist decision making by health care providers and patient decisions about appropriate healthcare for specific clinical circumstances and conditions.
Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by a carrier or utilization review organization to determine the medical necessity and appropriateness of health care services.
Commissioner means the Commissioner of Banking and Insurance.
"Covered person" means a person on whose behalf a carrier offering the plan is obligated to pay benefits or provide services pursuant to the health benefits plan.
"Health benefits plan" means a benefits plan which pays or provides hospital and medical expense benefits for covered services, and is delivered or issued for delivery in this State by or through a carrier. Health benefits plan includes, but is not limited to, Medicare supplement coverage and risk contracts to the extent not otherwise prohibited by federal law. For the purposes of this act, health benefits plan shall not include the following plans, policies, or contracts: accident only, credit, disability, long-term care, CHAMPUS supplement coverage, coverage arising out of a workers' compensation or similar law, automobile medical payment insurance, personal injury protection insurance issued pursuant to P.L.1972, c.70 (C.39:6A-1 et seq.), or hospital confinement indemnity coverage.
"Health care provider" means an individual or entity which, acting within the scope of its licensure or certification, provides a covered service defined by the health benefits plan. Health care provider includes, but is not limited to, a physician and other health care professionals licensed pursuant to Title 45 of the Revised Statutes, and a hospital and other health care facilities licensed pursuant to Title 26 of the Revised Statutes.
Medically necessary means health services and supplies that, under the applicable standard of care, are appropriate:
(1) to improve or preserve health, life, or function;
(2) to slow the deterioration of health, life, or function; or
(3) for the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury.
Step therapy exception means the overriding of a step therapy protocol in favor of immediate coverage of the health care providers selected prescription drug.
Step therapy protocol means a protocol, policy, or program that establishes the specific sequence in which prescription drugs for a specified medical condition, and medically appropriate for a particular patient, are required to be administered in order to be covered by a health benefits plan.
Utilization review organization means an entity that conducts utilization review, other than a carrier performing utilization review for its own health benefit plans.
3. a. Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:
(1) recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol;
(2) are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by:
(a) requiring members to disclose any potential conflict of interests with entities, including carriers and pharmaceutical manufacturers, and recuse themselves from voting if they have a conflict of interest;
(b) using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus; and
(c) offering opportunities for public review and comments; and
(3) are based on high quality studies, research, and m