An Act To Require Appropriate Coverage of and Cost-sharing for Generic Drugs and Biosimilars
Maine Legislature, Session 130, LD 1706
Committee: Health Coverage, Insurance and Financial Services
Sponsors: JACKSON
Amends: 24-A MRSA §4311-A

Legislative Document
No. 1706
S.P. 558
In Senate, May 13, 2021
An Act To Require Appropriate Coverage of and Cost-sharing for 
Generic Drugs and Biosimilars
Received by the Secretary of the Senate on May 11, 2021.  Referred to the Committee on 
Health Coverage, Insurance and Financial Services pursuant to Joint Rule 308.2 and ordered 
printed.
DAREK M. GRANT
Secretary of the Senate
Presented by President JACKSON of Aroostook.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  24-A MRSA §4311-A is enacted to read:
§4311-A.  Coverage of and cost-sharing for generic drugs and biosimilars
1.  Definitions.  As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "Biosimilar" means any biological product that is licensed under 42 United States 
Code, Section 262(k).
B.  "Biosimilar tier" means a cost-sharing tier of a formulary that includes a biosimilar, 
may include a generic drug and does not include a branded drug and provides an 
enrollee meaningfully lower cost-sharing for each biosimilar on the tier than the cost-
sharing applicable to the branded drug to which the biosimilar is equivalent. A single 
cost-sharing tier of a formulary may be both a biosimilar and a generic tier for purposes 
of this section.
C.  "Branded drug" means a drug for which an application has been approved under 21 
United States Code, Section 355(c) or a biological product other than a biosimilar that 
is licensed under 42 United States Code, Section 262(a).
D. "Cost-sharing" means the copayment amount or coinsurance percentage multiplied 
by prescription drug cost used to determine the amount payable by an enrollee of a 
health plan for a given covered prescription drug after satisfaction of any applicable 
deductible under the plan when dispensed by a pharmacy.
E.  "Equivalent" means:
(1) With respect to a generic drug, the branded drug against which the generic drug 
is evaluated by the United States Food and Drug Administration under 21 United 
States Code, Section 355(j); and
(2) With respect to a biosimilar, the branded drug biological reference product as 
defined in 42 United States Code, Section 262(i).
F.  "Generic drug" means a drug for which an application has been approved under 21 
United States Code, Section 355(i).
G.  "Generic tier" means a cost-sharing tier of a formulary drug that includes a generic 
drug, may include a biosimilar and does not include a branded drug and provides an 
enrollee meaningfully lower cost-sharing for each generic drug on the tier than the cost-
sharing applicable to the branded drug to which the generic drug is equivalent.
H.  "Meaningfully lower" means lower by an amount that significantly incentivizes an 
enrollee of a health plan to use a generic drug or biosimilar instead of an equivalent 
branded drug. 
I. "Step therapy" means a cost-savings measure that uses a less expensive drug to treat 
a condition before using another drug that is more expensive for an insurer.
2.  Cost-sharing.  If cost-sharing for a generic drug or biosimilar and the equivalent 
branded drug is based upon a coinsurance percentage, the coinsurance percentage for the 
generic drug or biosimilar must be meaningfully lower than the coinsurance percentage for 
the branded drug.  If a copayment or coinsurance is used to determine cost-sharing, the 
dollar amount payable to the enrollee for a generic drug or biosimilar must be meaningfully 
lower than the dollar amount payable for the equivalent branded drug.
3.  Generic drug and biosimilar coverage and cost-sharing requirements for 
health plans using a formulary.  If a health plan provides coverage for prescription drugs 
and the plan limits coverage to a drug included on a formulary, the carrier offering the plan, 
subject to subsection 4:
A.  With respect to a generic drug, if the branded drug to which the generic drug is 
equivalent is included on the formulary, shall include the equivalent generic drug on a 
generic tier of the formulary;
B.  With respect to a biosimilar, if the branded drug to which the biosimilar is 
equivalent is included on the formulary, shall include at least one biosimilar equivalent 
to the branded drug on a biosimilar tier of the formulary;
C.  May not impose any prior authorization, step therapy or other limitation on 
coverage of a generic drug or biosimilar for which formulary placement is required 
under this subsection or any restriction on a pharmacy through which an enrollee may 
obtain the generic drug or biosimilar that makes it more difficult for an enrollee to 
obtain coverage of or access to the generic drug or biosimilar than the equivalent 
branded drug; and
D. May not establish any benefit term or condition, pricing or other arrangement that 
results in an enrollee of a health plan bearing a higher out-of-pocket cost for a generic 
drug or biosimilar for which formulary placement is required under this subsection than 
for the equivalent branded drug, including higher prices borne by an enrollee through 
a deductible for the generic drug or biosimilar than for the equivalent branded drug.
4.  Limitation.  This section applies to a health plan offered by an insurer licensed 
under this Title or a health maintenance organization licensed under chapter 56.
This section does not preclude a carrier from offering a health plan providing coverage of 
all prescription drugs on a formulary with the same cost-sharing or no cost-sharing 
applicable to the prescription drugs.
SUMMARY
This bill requires that formularies for prescription drugs approved for coverage under 
a health plan contain tiers of generic drugs or biosimilars that are equivalent to the approved 
branded drugs, and that cost-sharing through coinsurance or a copayment make the cost of 
the generic drug or biosimilar meaningfully lower than the cost of the equivalent branded 
drug. A biosimilar is a biological product licensed by the United States Food and Drug 
Administration that is highly similar to a branded prescription drug.