An Act To Require Appropriate Coverage of and Cost-sharing for Generic Drugs and Biosimilars
Maine Legislature, Session 129, LD 2095
Committee: Health Coverage, Insurance and Financial Services
Sponsors: JACKSON, GIDEON, CARPENTER, FOLEY, FECTEAU, PRESCOTT, STEWART, WARREN
Amends: 24-A MRSA §4311-A

Legislative Document
No. 2095
S.P. 745
In Senate, February 4, 2020
An Act To Require Appropriate Coverage of and Cost-sharing for 
Generic Drugs and Biosimilars
Approved for introduction by a majority of the Legislative Council pursuant to Joint Rule 
203.
Reference to the Committee on Health Coverage, Insurance and Financial Services 
suggested and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by President JACKSON of Aroostook.
Cosponsored by Speaker GIDEON of Freeport and
Senators: CARPENTER of Aroostook, FOLEY of York, SANBORN, H. of Cumberland, 
Representatives: FECTEAU of Biddeford, PRESCOTT of Waterboro, STEWART of Presque 
Isle, WARREN of Hallowell.
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.  "Branded pharmaceutical" means:
(1)  A drug for which an application has been approved under 21 United States 
Code, Section 355(d); or
(2)  A biological product, other than a biosimilar, that is licensed under 42 United 
States Code, Section 262(a).
C.  "Formulary" has the same meaning as in section 4347, subsection 8.
D.  "Generic cost-sharing tier" means a cost-sharing tier that includes generic drugs 
and excludes branded pharmaceuticals and for which the enrollee cost-sharing 
amount is meaningfully lower than the cost-sharing amount applicable to the lowest 
branded cost-sharing tier.
E.  "Generic drug" means a drug for which an application has been approved under 
United States Code, Section 355(j).
F.  "Lowest branded cost-sharing tier" means the cost-sharing tier of a formulary that 
includes branded pharmaceuticals and provides for a lower level of enrollee cost-
sharing than any other cost-sharing tier of that formulary that includes branded 
pharmaceuticals.
G.  "Meaningfully lower" means lower in cost by an amount that significantly 
encourages enrollees to use, as applicable:
(1)  Generic drugs and biosimilars that are on a generic cost-sharing tier instead 
of branded pharmaceuticals on the formulary's lowest branded cost-sharing tier; 
or
(2)  Generic drugs and biosimilars that are specialty pharmaceuticals instead of 
branded pharmaceutical reference products.
H.  "Pharmacy and therapeutics committee" has the same meaning as in section 4347, 
subsection 16.
I.  "Reference product" means:
(1)  With respect to a generic drug, the listed branded pharmaceutical against 
which, in accordance with 21 United States Code, Section 355(j)(2)(A)(i), the 
generic drug was evaluated in the abbreviated application for that generic drug 
that was submitted and approved under 21 United States Code, Section 355(j); 
and
(2)  With respect to a biosimilar, the reference biological product as defined in 42 
United States Code, Section 1395w-3a(c)(6)(I).
J.  "Specialty pharmaceutical" means a branded pharmaceutical, generic drug or 
biosimilar for which the wholesale acquisition cost exceeds the threshold set for a 
specialty drug under the Medicare Part D program. For the purposes of this 
paragraph, "Medicare Part D" has the same meaning as in Title 22, section 254-D, 
subsection 1, paragraph F.
K.  "Wholesale acquisition cost" has the same meaning as in Title 22, section 8731, 
subsection 6.
2.  Generic drug and biosimilar coverage and enrollee access requirements for 
health plans using a formulary.  If a health plan offered by a carrier in this State 
provides coverage for prescription drugs and the plan limits coverage to drugs included 
on a formulary, the carrier offering that health plan, subject to the limitations set forth in 
subsection 4:
A.  Shall include on the formulary at least one generic drug or biosimilar that has a 
wholesale acquisition cost that is lower than the wholesale acquisition cost for the 
generic drug or biosimilar's branded pharmaceutical reference product, unless the 
generic drug or biosimilar is a specialty pharmaceutical;
B.  Shall include on the formulary each generic drug or biosimilar that is a specialty 
pharmaceutical if the formulary includes the branded pharmaceutical reference 
product for the generic drug or biosimilar and the generic drug or biosimilar has a 
lower wholesale acquisition cost than its branded pharmaceutical reference product;
C.  May not impose any limitation on coverage of or enrollee access to a generic drug 
or biosimilar for which formulary placement is required under paragraph A or B that:
(1) Is more restrictive than any limitation applicable to the branded 
pharmaceutical reference product for that generic drug or biosimilar if that 
branded pharmaceutical reference product is included on the formulary;
(2)  Has the effect of favoring the branded pharmaceutical product; or
(3)  Restricts the pharmacies through which enrollees may obtain the generic 
drug or biosimilar that is not also applicable to the branded pharmaceutical 
reference product; and
D.  With respect to any generic drug or biosimilar that is a specialty pharmaceutical 
and has a lower wholesale acquisition cost than the wholesale acquisition cost of its 
branded pharmaceutical reference product, if neither the generic drug or biosimilar 
nor its branded pharmaceutical reference product is included on the health plan's 
formulary, may not impose any requirement for coverage of that generic drug or 
biosimilar as an exception to the formulary that is more restrictive than the 
requirements for coverage of the branded pharmaceutical reference product as an 
exception to the formulary.
3.  Cost-sharing requirements.  Except as provided in subsection 4, if a health plan 
offered by a carrier in this State provides coverage for prescription drugs using a tiered 
formulary cost-sharing arrangement:
A.  For each generic drug and biosimilar for which coverage is required under 
subsection 2, paragraph A, the carrier offering the health plan shall provide coverage 
on a generic cost-sharing tier; and
B.  For each generic drug and biosimilar that is a specialty pharmaceutical and for 
which coverage is required under subsection 2, paragraph B, the carrier offering the 
health plan shall provide coverage at a meaningfully lower cost-sharing amount than 
the cost-sharing amount provided for the branded pharmaceutical reference product 
for that generic drug or biosimilar.
4.  Application; limitations.  The requirements set forth in subsections 2 and 3:
A.  Apply only with respect to coverage of and cost-sharing for generic drugs, 
biosimilars and branded pharmaceuticals when dispensed by pharmacies as outpatient 
prescription drugs and do not apply to generic drugs, biosimilars or branded 
pharmaceuticals when provided by a hospital, physician or other provider of health 
care or palliative services, other than a pharmacy, incident to the services of that 
provider and paid for by or on behalf of the relevant health plan as part of the 
payment for such services under the medical benefit of the health plan;
B.  Do not apply to the extent that they would require coverage of or enrollee cost-
sharing for a generic drug or biosimilar under a health plan that is not permitted under 
any applicable federal law or any law of this State; and
C.  Do not require that a health plan include on its formulary a generic drug or 
biosimilar if the carrier has not included the branded pharmaceutical for that generic 
drug or biosimilar on its formulary due to a determination by the pharmacy and 
therapeutics committee for that health plan that the branded pharmaceutical should 
not be covered due to clinical concerns about the safety or efficacy of the branded 
pharmaceutical based on the strength of scientific evidence.
5.  No cost-sharing or single copayment amount not precluded.  Nothing in this 
section precludes a carrier from offering a health plan providing coverage of those 
generic drugs and biosimilars for which coverage is required under subsection 2, 
paragraph A or B and all branded pharmaceuticals on the formulary of the given health 
plan without any enrollee cost-sharing or for a single copayment amount applicable to all 
covered pharmaceuticals.
SUMMARY
This bill establishes requirements for the coverage of and cost-sharing for generic 
drugs, biosimilars and branded pharmaceuticals when dispensed by pharmacies as 
outpatient prescription drugs under health plans offered by carriers that provide coverage 
for prescription drugs.