An Act Regarding Prescription Drug Step Therapy
Maine Legislature, Session 128, LD 1407
Committee Amendment CA_A_S245 (Senate)

COMMITTEE AMENDMENT "A" to S.P. 485, L.D. 1407, Bill, "An Act 
Regarding Prescription Drug Step Therapy" 
Amend the bill in section 1 in §4320-K in subsection 1 in paragraph A in the 2nd line 
(page 1, line 7 in L.D.) by striking out the following: "patient" and inserting the 
following: 'emollee' 
Amend the bill in section 1 in §4320-K in subsection 1 in paragraph Bin the 2nd line 
(page 1, line 10 in L.D.) by striking out the following: "an insurer, health plan" and 
inserting the following: 'a ca1Tier' 
Amend the bill in section 1 in §4320-K in subsection 1 in paragraph Din the 2nd line 
(page 1, line 19 in L.D.) by striking out the following: "a patient's" and inserting the 
following: 'an enrollee's' 
Amend the bill in section 1 in §4320-K in subsection 1 by striking out all of 
paragraph E (page 1, lines 22 to 25 in L.D.) and inserting the following: 
'E. "Step therapy protocol" means a protocol that establishes a specific sequence in 
which prescription drugs for a specified medical condition are medically necessaty 
for a particular enrollee and are covered under a pharmacy or medical benefit by a 
carrier, including self-administered and physician-administered drugs.' 
Amend the bill in section 1 in §4320-K in subsection 1 in paragraph Fin the 2nd line 
(page 1, line 27 in L.D.) by striking out the following: "an insurer or health plan" and 
insetting the following: 'a carrier' 
Amend the bill in section 1 in §4320-K in subsection 2 in paragraph B in 
subparagraph (1) in the 2nd line (page 1, line 36 in L.D.) by striking out the following: 
"insurers, health plans" and inseiting the following: 'carriers' 
Amend the bill in section 1 in §4320-K in subsection 5 in the first line (page 2, line 
in L.D.) by striking out the following: "insurers, health plans" and inserting the 
following: 'carriers' 
COMMITTEE AMENDMENT 
COMMIITEE AMENDMENT "A" to S.P. 485, L.D. 1407 
Amend the bill in section 1 in §4320-K by striking out all of subsection 6 (page 2, 
lines 22 to 38 and page 3, lines I to 28 in L.D.) and inserting the following: 
'6. Exceptions process. When coverage of a prescription drug for the treatment of 
any medical condition is restricted for use by a caITier 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 oveITide 
exception detennination from that catTier or utilization review organization. 
A. 
A carrier or utilization review organization may use its existing medical 
exceptions process to provide step therapy ove1Tide exception detenninations, and the 
process established must be easily accessible on the catTier's or utilization review 
organization's website. 
B. 
A carrier or utilization review organization shall expeditiously grant a step 
therapy ovenide exception detennination 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 cmTent 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 event; 
( 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. 
C. Upon the granting of a step therapy override exception determination, the catTier 
or utilization review organization shall authorize coverage for the prescription drug 
prescribed by the prescriber. 
D. A ca1Tier or utilization review organization shall respond to a request for a step 
therapy override exception detennination or an appeal of a detennination in 
accordance with the requirements of section 4304 and Bureau of Insurance Rule 
Chapter 850, Health Plan Accountability. If a response by a carrier or utilization 
review organization is not received within the time required under this paragraph, the 
7 
exception or appeal is granted. 
8 
E. An enrollee may appeal a step therapy oveITide exception detennination. 
F. This section does not prevent: 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT"f\ "to S.P. 485, L.D. 1407 
(1) A canier or utilization review organization from requiring an emollee 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 1s 
detennined to be medically necessary.' 
Amend the bill in section 1 in §4320-K in subsection 7 in the first line (page 3, line 
in L.D.) by striking out the following: "shall" and inserting the following: 'may' 
Amend the bill in section 2 in the 3rd line (page 3, line 34 in L.D.) by striking out the 
following: "2018" and inserting the following: '2019' 
SUMMARY 
This amendment does the following. 
1. It clarifies that carriers must apply the utilization review standards under cmTent 
law when acting on a request for a step therapy override exception dete1mination or an 
appeal of a dete1mination. 
2. It replaces certain te1minology used in the bill to be consistent with cunent law. 
3. It changes the applicability of the bill's provisions from January 1, 2018 to January 
1,2019. 
FISCAL NOTE REQUIRED 
(See att~ched) 
COMMITTEE AMENDMENT 
Fiscal Detail and Notes 
Revised: 06/08/17 fe.ac 
LD 1407 
LR 1195(02) 
An Act Regarding Prescription Drug Step Therapy 
Fiscal Note for Bill as Amended by Committee Amendment "ff,- ls -:;), LI s) 
Committee: Insurance and Financial Services 
Fiscal Note Required: Yes 
Fiscal Note 
Potential future biennium cost -All Funds 
The bill has an effective date of January 1, 2019, so only contracts executed after January 1, 2019 will be required to 
meet the coverage in this bill. Thus, the State Employee Health Plan (SEHP) will have no General Fund 
appropriations or Highway Fund allocations in the current biennium. Drug step therapy is the practice of beginning 
drug therapy for a medical condition with the most cost-effective and safest drug and progressing to other more costly 
or risky therapies only if necessary, with the goal of controlling costs and minimizing risks. This bill adds an 
exception process that must be clear, readily accessible and convenient to the patient and prescriber. This could lead 
to additional or longer lasting exceptions from the drug step therapy process, which could potentially increase costs in 
future bienniums for insurers, including the SEHP. However, there is not enough infonnation available to identify a 
fiscal impact at this time. 
LRl 195(02) - Fiscal Note - Page 1 of 1