APPROVED CHAPTER
JUNE 21, 2021 305
BY GOVERNOR PUBLIC LAW
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND TWENTY-ONE
_____
S.P. 274 - L.D. 686
An Act To Increase Prescription Drug Pricing Transparency
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA §8731, sub-§1-A is enacted to read:
1-A. Drug product family. "Drug product family" means a group of one or more
prescription drugs that share a unique generic drug description and drug form.
Sec. 2. 22 MRSA §8731, sub-§3, as enacted by PL 2019, c. 470, §8, is amended to
read:
3. Manufacturer. "Manufacturer" means a manufacturer of an entity that
manufactures or repackages, and sets the wholesale acquisition cost for, prescription drugs
that are distributed in the State.
Sec. 3. 22 MRSA §8731, sub-§3-A is enacted to read:
3-A. Prescription drug. "Prescription drug" means a drug, as defined in 21 United
States Code, Section 321(g) or a biological product as defined in 42 United States Code,
Section 262(i)(1) that:
A. Is intended for human use;
B. Is not a device within the meaning of 21 United States Code, Section 321(h); and
C. By federal or state law, can be lawfully dispensed or administered only on
prescription by a licensed health care professional.
Sec. 4. 22 MRSA §8732, sub-§1, as enacted by PL 2019, c. 470, §8, is amended
by enacting at the end a new blocked paragraph to read:
This subsection is repealed January 30, 2022.
Sec. 5. 22 MRSA §8732, sub-§1-A is enacted to read:
1-A. Public notice of substantial drug price change or introduction. No later than
January 30, 2022 and annually thereafter, the organization shall produce and post on its
publicly accessible website a list of prescription drugs for which the manufacturer has
during the prior calendar year:
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 A. Increased the wholesale acquisition cost of a brand-name drug by more than 20%
per pricing unit;
B. Increased the wholesale acquisition cost of a generic drug that costs at least $10 per
pricing unit by more than 20% per pricing unit; or
C. Introduced a new drug for distribution in this State when the wholesale acquisition
cost is greater than the amount that would cause the drug to be considered a specialty
drug under the Medicare Part D program. For the purposes of this paragraph, "Medicare
Part D" has the same meaning as in section 254‑D, subsection 1, paragraph F.
Sec. 6. 22 MRSA §8732, sub-§2, as enacted by PL 2019, c. 470, §8, is repealed
and the following enacted in its place:
2. Disclosures by manufacturers, wholesale drug distributors and pharmacy
benefits managers. The following disclosures apply to manufacturers, wholesale drug
distributors and pharmacy benefits managers.
A. On or before February 15th of each year, the organization shall produce and post
on its publicly accessible website a list of drug product families for which it intends to
request pricing component data from manufacturers, wholesale drug distributors and
pharmacy benefits managers. The organization shall base its inclusion of drug product
families on any information the organization determines is relevant to providing greater
consumer awareness of the factors contributing to the cost of prescription drugs in the
State, and the organization shall consider drug product families that include
prescription drugs:
(1) Included in the public notice of substantial drug price change or introduction
under subsection 1-A; and
(2) For which the organization is required to produce an annual report pursuant to
section 8712, subsection 5, including, but not limited to, the 25 costliest drugs, the
25 most frequently prescribed drugs in the State and the 25 drugs with the highest
year-over-year cost increases.
B. Not sooner than 30 days after publicly posting the list of drug product families
pursuant to paragraph A, the organization shall notify, via e-mail, manufacturers,
wholesale drug distributors and pharmacy benefits managers pursuant to paragraph C.
C. Within 60 days from the date of a request from the organization relating to a specific
prescription drug, a manufacturer, wholesale drug distributor or pharmacy benefits
manager shall notify the organization of pricing component data per pricing unit of the
prescription drug.
Sec. 7. 22 MRSA §8733, as enacted by PL 2019, c. 470, §8, is amended to read:
§8733. Confidentiality
Information provided to the organization as required by this subchapter by a
manufacturer, wholesale drug distributor or pharmacy benefits manager is confidential and
not a public record under Title 1, chapter 13, except that the organization may share
information:
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 1. Bureau of Insurance. With the Department of Professional and Financial
Regulation, Bureau of Insurance, to the extent necessary for the bureau to enforce the
provisions of Title 24‑A, as long as any information shared is kept confidential; and
2. Aggregate. In the aggregate, as long as it is not released in a manner that allows
the identification of an individual drug or determination of individual prescription drug
pricing contract terms covering a manufacturer, wholesale drug distributor or pharmacy
benefits manager.; and
3. Publicly available. That is available, for purchase or otherwise, to the public.
Sec. 8. 22 MRSA §8734, as enacted by PL 2019, c. 470, §8, is amended to read:
§8734. Registration requirements
Beginning January 1, 2020, a manufacturer and manufacturers, wholesale drug
distributor distributors and pharmacy benefits managers subject to this subchapter shall
register annually with the organization in a manner prescribed by the organization.
Sec. 9. 22 MRSA §8736, as enacted by PL 2019, c. 470, §8, is amended to read:
§8736. Public report
Beginning November 1, 2020 and annually thereafter, the organization shall produce
and post on its publicly accessible website an annual report, including information
developed from the notifications and disclosures received pursuant to this subchapter on
trends in the cost of prescription drugs, analysis of manufacturer prices and price increases,
the major components of prescription drug pricing along the supply chain and the impacts
on insurance premiums and cost sharing and any other information the organization
determines is relevant to providing greater consumer awareness of the factors contributing
to the cost of prescription drugs in the State. The report may not disclose information
attributable to any particular manufacturer, wholesale drug distributor or pharmacy benefits
manager subject to this subchapter and may not make public any information that is
confidential pursuant to section 8733. The organization shall submit the report required by
this section to the joint standing committee of the Legislature having jurisdiction over
health data reporting and prescription drug matters and the committee may report out
legislation to the first regular or second regular session of the Legislature, depending on
the year in which the report is submitted.
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Statutes affected:
Bill Text LD 686, SP 274: 22.8731, 22.8732, 22.8733, 22.8734, 22.8736
Bill Text ACTPUB , Chapter 305: 22.8731, 22.8732, 22.8733, 22.8734, 22.8736