30:4D-7xx Prescription drug coverage restriction, step therapy protocol, exception process, managed care organization.
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/nj/title-30/chapter-4d/30-4d-7xx·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
4. Notwithstanding the provisions of any law, rule, or regulation to the contrary:
a. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by a managed care organization pursuant to a step therapy protocol, the managed care organization shall provide the enrollee and prescribing practitioner a clear, readily accessible, and convenient process to request a step therapy exception. A managed care organization may use its existing medical exceptions process to satisfy this requirement. An explanation of the process shall be made available on the managed care organization's website.
A managed care organization shall disclose all rules and criteria related to the step therapy protocol upon request to all prescribing practitioners, including the specific information and documentation required to be submitted by a prescribing practitioner or patient for an exception request to be complete.
b. A step therapy exception shall be granted if the prescribing health care provider determines that:
(1)the required prescription drug is contraindicated or is likely to cause an adverse reaction or physical or mental harm to the patient;
(2)the required prescription drug is expected to be ineffective or less effective than an alternative based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen; or
(3)all formulary drugs used to treat each disease state have been ineffective or less effective than an alternative in the treatment of the enrollee's disease or condition or all such drugs have caused or are reasonably expected to cause adverse or harmful reactions in the enrollee.
If requested by a managed care organization, the prescribing health care provider shall provide documentation to support the determinations made by the provider pursuant to paragraphs
(1)through
(3)of this subsection.
c. When a step therapy exception is granted, the managed care organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider at least 180 days or the duration of therapy if less than 180 days, provided that the prescription drug is covered under the managed care organization's formulary.
d. Any step therapy exception shall be eligible for appeal by an enrollee. The managed care organization shall grant or deny a step therapy exception request or an appeal of a step therapy exception request within a time frame appropriate to the medical exigencies of the case, but no later than 24 hours for urgent requests and 72 hours for non-urgent requests after obtaining all necessary information to make the approval or adverse determination.
e. Any step therapy exception pursuant to this section shall be eligible for appeal by an enrollee.
f. This section shall not be construed to prevent:
(1)a managed care organization from requiring a patient to try an AB-rated generic equivalent, biosimilar, or interchangeable biological product prior to providing coverage for the equivalent branded prescription drug;
(2)a managed care organization from requiring a pharmacist to effect substitutions of prescription drugs consistent with the laws of this State; or
(3)a health care provider from prescribing a prescription drug that is determined to be medically appropriate.
L.2025, c.50, s.4.