Missouri HB 2571: Modifies provisions for step therapy.

Bill Text

SECOND REGULAR SESSION
HOUSE BILL NO. 2571
100TH GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE STEPHENS (128).
5572H.01IDANA RADEMAN MILLER, Chief Clerk
AN ACT
To repeal sections 376.2030, 376.2034, and 376.2036, RSMo, and to enact in lieu thereof four
new sections relating to step therapy protocol.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A.  Sections 376.2030, 376.2034, and 376.2036, RSMo, are repealed and four
2new sections enacted in lieu thereof, to be known as sections 376.2030, 376.2032, 376.2036, and
3376.2038, to read as follows:
376.2030.  As used in sections 376.2030 to [376.2036] 376.2038, the following terms
2mean:
3(1)  "Clinical practice guidelines", systematically developed protocols to assist
4decision making by health care providers and patients in specific clinical circumstances
5and conditions;
6(2)  "Clinical review criteria", the written screening procedures, decision abstracts,
7clinical protocols, and practice guidelines used by a health benefit plan, health carrier, or
8utilization review organization to determine the medical necessity and appropriateness of
9health care services;
10(3)  "Health benefit plan", the same meaning as such term is defined in section 376.1350;
11[(2)] (4)  "Health care provider", the same meaning as such term is defined in section
12376.1350;
13[(3)] (5)  "Health carrier", the same meaning as such term is defined in section 376.1350;
14(6)  "Medically necessary", health services and supplies that are appropriate under
15the applicable standard of care to:
16(a)  Improve or preserve health, life, or function;
EXPLANATION —Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended
to be omitted from the law. Matter in bold-face type in the above bill is proposed language.

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17(b)  Slow the deterioration of health, life, or function; or
18(c)  Facilitate the early screening, prevention, evaluation, diagnosis, or treatment
19of a disease, condition, illness, or injury;
20[(4)] (7)  "Step therapy override exception determination", a determination as to whether
21a step therapy protocol should apply in a particular situation, or whether the step therapy protocol
22should be overridden in favor of immediate coverage of the health care provider's preferred
23prescription drug.  This determination is based on a review of the patient's health care provider's
24request for an override, along with supporting rationale and documentation;
25[(5) "Step therapy override exception request", a written request from the patient's health
26care provider for the step therapy protocol to be overridden in favor of immediate coverage of
27the health care provider's preferred prescription drug.  The manner and form of the written
28request shall be disclosed to the patient and the health care provider as described in subsection
291 of section 376.2034;
30(6)] (8)  "Step therapy protocol", a protocol or program that establishes the specific
31sequence in which prescription drugs for a specified medical condition and medically appropriate
32for a particular patient are to be prescribed and covered by a health carrier or health benefit plan;
33[(7)] (9)  "Utilization review organization", an entity that conducts utilization review
34other than an insurer or health carrier performing utilization review for its own health benefit
35plans.
376.2032.  1.  Clinical review criteria used to establish a step therapy protocol shall
2be based on clinical practice guidelines that:
3(1)  Recommend that prescription drugs be taken in the specific sequence required
4by the step therapy protocol;
5(2)  Are developed and endorsed by a multidisciplinary panel of experts that
6manages conflicts of interest among members by:
7(a)  Requiring members to disclose any potential conflicts of interest with any
8relevant entities including, but not limited to, health benefit plans, health carriers, and
9pharmaceutical manufacturers;
10(b)  Requiring members to recuse themselves from any vote in which they have a
11conflict of interest;
12(c)  Using a methodologist to work with writing groups to provide objectivity in data
13analysis and ranking of evidence through preparing evidence tables and facilitating
14consensus; and
15(d)  Offering opportunity for public comment and review;
16(3)  Are based on high quality studies, research, and medical practices;
17(4)  Are created by an explicit and transparent process that:

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18(a)  Minimizes biases and conflicts of interest;
19(b)  Explains the relationship between treatment options and outcomes;
20(c)  Rates the quality of the evidence supporting recommendations;
21(d)  Considers relevant patient subgroups and preferences; and
22(e)  Considers the needs of atypical patient populations and diagnoses when
23establishing clinical review criteria; and
24(5)  Are continually updated through a review of new evidence, research, and newly
25developed treatments.
262.  Notwithsta