An Act To Provide Protections for Maine Patients Facing Step Therapy
Maine Legislature, Session 129, LD 1009
Committee: Health Coverage, Insurance and Financial Services
Sponsors: WARREN, SANBORN, GRAMLICH, PIERCE, PRESCOTT, TEPLER, FOLEY, ROSEN, VITELLI
Amends: 24-A MRSA §4320-L

Legislative Document
No. 1009
H.P. 751
House of Representatives, February 26, 2019
An Act To Provide Protections for Maine Patients Facing Step 
Therapy
Reference to the Committee on Health Coverage, Insurance and Financial Services 
suggested and ordered printed.
ROBERT B. HUNT
Clerk
Presented by Representative WARREN of Hallowell.
Cosponsored by Senator SANBORN, H. of Cumberland and
Representatives: GRAMLICH of Old Orchard Beach, PIERCE of Falmouth, PRESCOTT of 
Waterboro, TEPLER of Topsham, Senators: FOLEY of York, ROSEN of Hancock, 
SANBORN, L. of Cumberland, VITELLI of Sagadahoc.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  24-A MRSA §4320-L is enacted to read:
§4320-L.  Step therapy
1. Definitions.  As used in this section, unless the context otherwise indicates, the
following terms have the following meanings.
A.  "Clinical practice guidelines" means a systematically developed statement to 
assist prescriber and enrollee decisions about appropriate health care for specific 
clinical circumstances and conditions.
B.  "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.
C.  "Medically necessary," with respect to health services and supplies, means 
appropriate, under the applicable standard of care, to improve or preserve health, life 
or function; to slow the deterioration of health, life or function; or for the early 
screening, prevention, evaluation, diagnosis or treatment of a disease, condition, 
illness or injury.
D.  "Pharmaceutical sample" means a unit of a prescription drug that is not intended 
to be sold and is intended to promote the sale of the drug.
E.  "Step therapy override exception determination" means a determination based on 
a review of an enrollee's or prescriber's request for an override, along with supporting 
rationale and documentation, that the step therapy protocol should be overridden in 
favor of immediate coverage of the health care provider's selected prescription drug.
F.  "Step therapy protocol" means a protocol that establishes a specific sequence in 
which prescription drugs for a specified medical condition are medically necessary 
for a particular enrollee and are covered under a pharmacy or medical benefit by a 
carrier, including self-administered and physician-administered drugs.
G.  "Utilization review organization" means an entity that conducts a utilization 
review, other than a carrier performing a utilization review for its own health benefit 
plans.
2. Clinical review criteria.  Clinical review criteria used to establish a step therapy
protocol must be based on clinical practice guidelines that:
A.  Recommend that the prescription drugs be taken in the specific sequence required 
by the step therapy protocol;
B.  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:
(1)  Requiring members to disclose any potential conflicts of interest with 
entities, including carriers and pharmaceutical manufacturers, and recuse 
themselves from voting if they have a conflict of interest;
(2)  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
(3)  Offering opportunities for public review and comments;
C.  Are based on high-quality studies, research and medical practice;
D.  Are created by an explicit and transparent process that:
(1)  Minimizes biases and conflicts of interest;
(2)  Explains the relationship between treatment options and outcomes;
(3)  Rates the quality of the evidence supporting recommendations; and
(4)  Considers relevant patient subgroups and preferences; and
E.  Are continually updated through a review of new evidence, research and newly 
developed treatments.
3.  Absence of clinical practice guidelines.  In the absence of clinical practice 
guidelines that meet the requirements in subsection 2, peer-reviewed publications may be 
substituted.
4.  Consideration of atypical populations and diagnoses.  When establishing a step 
therapy protocol, a utilization review organization shall also take into account the needs 
of atypical patient populations and diagnoses when establishing clinical review criteria.
5.  Construction.  This section may not be construed to require carriers or the State 
to set up a new entity to develop clinical review criteria used for step therapy protocols.
6.  Exceptions process.  When coverage of a prescription drug for the treatment of 
any medical condition is restricted for use by a carrier or utilization review organization 
through the use of a step therapy protocol, the enrollee and prescriber must have access to 
a clear, readily accessible and convenient process to request a step therapy override 
exception determination from that carrier or utilization review organization.
A.  A carrier or utilization review organization may use its existing medical 
exceptions process to provide step therapy override exception determinations, and the 
process established must be easily accessible on the carrier's or utilization review 
organization's website.
B.  A carrier or utilization review organization shall expeditiously grant a step 
therapy override exception determination if:
(1)  The required prescription drug is contraindicated or will likely cause an 
adverse reaction in or physical or mental harm to the enrollee;
(2)  The required prescription drug is expected to be ineffective based on the 
known clinical characteristics of the enrollee and the known characteristics of the 
prescription drug regimen;
(3)  The enrollee has tried the required prescription drug while under the 
enrollee's current or previous health insurance or health plan, or another 
prescription drug in the same pharmacologic class or with the same mechanism 
of action, and the prescription drug was discontinued due to lack of efficacy or 
effectiveness, diminished effect or an adverse reaction;
(4)  The required prescription drug is not in the best interest of the enrollee, based 
on medical necessity; or
(5)  The enrollee is stable on a prescription drug selected by the enrollee's health 
care provider for the medical condition under consideration while on a current or 
previous health insurance or health plan.
Nothing in this paragraph may be construed to encourage the use of a pharmaceutical 
sample for the sole purpose of meeting the requirements for the granting of a step 
therapy override exception determination.
C.  Upon the granting of a step therapy override exception determination, the carrier 
or utilization review organization shall authorize coverage for the prescription drug 
prescribed by the prescriber.
D.  A carrier or utilization review organization shall grant or deny a request for a step 
therapy override exception determination or an appeal of a determination within 48 
hours after receipt of the request.  If exigent circumstances exist, a carrier or 
utilization review organization shall grant or deny the request within 24 hours after 
receipt of the request.  If a carrier or utilization review organization does not grant or 
deny the request within the time required under this paragraph, the exception or 
appeal is granted.
E.  An enrollee may appeal a step therapy override exception determination.
F.  This section does not prevent:
(1)  A carrier or utilization review organization from requiring an enrollee to try a 
generic drug, as defined in Title 32, section 13702-A, subsection 14, prior to 
providing coverage for the equivalent brand-name prescription drug; or
(2)  A health care provider from prescribing a prescription drug that is 
determined to be medically necessary.
7.
Rules.  The superintendent may adopt rules to implement this section.  The
superintendent shall adopt a rule defining the circumstances under which a carrier or 
utilization review organization is required to grant or deny a request within 24 hours 
pursuant to subsection 6, paragraph D.  Rules adopted pursuant to this subsection are 
routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.
Sec. 2.  Application.  The requirements of this Act apply to all policies, contracts 
and certificates executed, delivered, issued for delivery, continued or renewed in this 
State on or after January 1, 2020.  For purposes of this Act, all contracts are deemed to be 
renewed no later than the next yearly anniversary of the contract date.
SUMMARY
This bill requires health insurance carriers to establish a process for prescription drug 
step therapy exceptions.