30:4D-7ww Clinical review criteria, guidelines, step therapy protocol, Medicaid.
346 words·~2 min read·
/nj/title-30/chapter-4d/30-4d-7wwA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
3. a. The division or a managed care organization shall require that clinical review criteria used to establish a step therapy protocol under Medicaid are based on clinical practice guidelines developed by the division or a managed care organization 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:
(a)relies on objective data; and
(b)manages conflicts of interest among the members by requiring members to disclose any potential conflict of interests with entities, including managed care organizations, carriers, and pharmaceutical manufacturers and recuse themselves from voting if they have a conflict of interest;
(3)are based on high-quality studies, research, and medical practice;
(4)are created by an explicit and transparent process that:
(a)minimizes biases and conflicts of interest;
(b)explains the relationship between treatment options and outcomes;
(c)rates the quality of the evidence supporting recommendations; and
(d)considers relevant patient subgroups and preferences; and
(5)are reviewed annually or quarterly if there is a new indication or new clinical information available and updated when such review reveals new evidence necessitating modification.
b. In the absence of clinical guidelines that meet the requirements in subsection a. of this section, peer-reviewed publications may be substituted.
c. When establishing a step therapy protocol, the division or managed care organization shall also consider the needs of atypical patient populations and diagnoses when establishing clinical review criteria.
d. A managed care organization shall:
(1)upon written request, provide written clinical review criteria relating to a particular condition or disease, including clinical review criteria relating to a step therapy protocol exception determination; and
(2)make available the clinical review criteria and other clinical information on its Internet website and to a health care professional on behalf of an insured person upon written request.
e. This section shall not be construed to require managed care organizations or the State to establish a new entity to develop clinical review criteria used for step therapy protocols.
L.2025, c.50, s.3.