Printed on recycled paper 131st MAINE LEGISLATURE FIRST SPECIAL SESSION-2023 Legislative Document No. 1829S.P. 745 In Senate, April 27, 2023 An Act to Reduce Prescription Drug Costs by Requiring Reference- based Pricing Reference to the Committee on Health Coverage, Insurance and Financial Services suggested and ordered printed. DAREK M. GRANT Secretary of the Senate Presented by Senator RENY of Lincoln. Cosponsored by President JACKSON of Aroostook, Representative PERRY of Calais and Senators: BAILEY of York, CURRY of Waldo, RAFFERTY of York, VITELLI of Sagadahoc, Representatives: CLOUTIER of Lewiston, MATHIESON of Kittery, MEYER of Eliot, Speaker TALBOT ROSS of Portland. Page 1 - 131LR0735(01) 1 2 3 4 5 6 As used in this section, unless the context otherwise indicates, the 7 following terms have the following meanings. 8 A. "Carrier" has the same meaning as in Title 24-A, section 4301-A, subsection 3. 9 B. "ERISA plan" means a plan qualified under the federal Employee Retirement 10 Income Security Act of 1974. 11 C. "Health plan" has the same meaning as in Title 24-A, section 4301-A, subsection 12 7. 13 D. "Participating ERISA plan sponsor" means an ERISA plan sponsor that has elected 14 to participate in the requirements and restrictions of this section as described in 15 subsection 3. 16 E. "Prescription drug" has the same meaning as in Title 32, section 13702-A, 17 subsection 30. 18 F. "Price applicability period" means the period of time defined in United States Public 19 Law 117-169, Section 1191 (2022). 20 G. "Referenced drugs" means prescription drugs subject to a referenced rate. 21 H. "Referenced rate" means the maximum rate for a prescription drug published by 22 the Secretary of the United States Department of Health and Human Services pursuant 23 to United States Public Law 117-169, Section 1195 (2022). 24 I. "State entity" means any agency of State Government that purchases prescription 25 drugs on behalf of the State for a person whose health care is paid for by the State, 26 including any agent, vendor, fiscal agent, contractor or other party acting on behalf of 27 the State. "State entity" does not include the medical assistance program established 28 under 42 United States Code, Section 1396 et seq. 29 The following practices are 30 prohibited. 31 A. It is a violation of this section to dispense, deliver or administer to a consumer in 32 the State in person, by mail or by another means a prescription drug for a cost that 33 exceeds the referenced rate during the price applicability period. 34 B. It is a violation of this section for a state entity, carrier offering a health plan or 35 participating ERISA plan sponsor to purchase referenced drugs or seek reimbursement 36 for referenced drugs to be dispensed or delivered to a consumer in the State, whether 37 directly or through a distributor, for a cost higher than the referenced rate. Contracts 38 entered into by a state entity, carrier or participating ERISA plan sponsor and a 3rd Page 2 - 131LR0735(01) 39 party for the purchase of prescription drugs must expressly provide that rates paid for 40 referenced drugs may not exceed the referenced rate. 3 C. It is a violation of this section for a retail pharmacy licensed in the State to purchase 4 for sale or seek reimbursement for a prescription drug to be dispensed or delivered to 5 a consumer whose health care is provided by a state entity, health plan or participating 6 ERISA plan at a cost that exceeds the referenced rate. The referenced rate does not 7 include a dispensing fee paid to a retail pharmacy, and this chapter may not be 8 construed to prevent a retail pharmacy from receiving a dispensing fee above the 9 referenced rate. 10 An ERISA plan sponsor may elect to 11 participate in the provisions of this section. An ERISA plan sponsor that elects to 12 participate in the requirements of this section shall notify the Superintendent of Insurance 13 in writing by December 15th of each year. 14 The Superintendent of Insurance may adopt rules to carry out the purposes 15 of this subchapter. Rules adopted pursuant to this subsection are routine technical rules 16 under Title 5, chapter 375, subchapter 2-A. 17 An entity that sells, distributes, 18 delivers or offers for sale any prescription drug in the State shall maintain a registered agent 19 and office within the State. 20 The following provisions govern the use of savings generated as a 21 result of the requirements in subsection 2. 22 A. Any savings generated as a result of the requirements in subsection 2 during the 23 price applicability period must be used to reduce costs to consumers. A state entity, 24 carrier or participating ERISA plan sponsor shall calculate its savings and use the 25 savings directly to reduce costs for its members. In determining how to use savings in 26 order to comply with this subsection, a state entity, carrier or participating ERISA plan 27 sponsor shall consider strategies that promote greater health equity by addressing 28 health disparities across communities. 29 B. No later than April 1st of each calendar year, each state entity, carrier or 30 participating ERISA plan sponsor subject to this section shall submit to the 31 Superintendent of Insurance a report describing the savings achieved for each 32 referenced drug for the previous calendar year and how those savings were used to 33 achieve the requirements under paragraph A, including if the savings were used to 34 promote greater health equity by addressing health disparities across communities. 35 C. The Superintendent of Insurance shall adopt and implement rules setting forth the 36 method for calculating savings and the format and manner for submitting the report 37 under paragraph B. 38 Each violation of this section is subject to a fine of $1,000. Each 39 individual transaction in violation of subsection 2 is a separate violation. The Attorney 40 General is authorized to enforce the provisions of this section on behalf of any state entity 41 or consumer of prescription drugs. The refusal of a manufacturer or distributor of 42 prescription drugs to negotiate in good faith as described in subsection 8 is a valid 43 affirmative defense in any enforcement action brought under this subchapter. 1 2 Page 3 - 131LR0735(01) 1 The following 2 provisions govern the withdrawal of a referenced drug. 3 A. A manufacturer or distributor of a referenced drug may not withdraw that drug from 4 sale or distribution within the State for the purpose of avoiding the effect of the rate 5 limitations set forth in subsection 2. 6 B. A manufacturer that intends to withdraw a referenced drug from sale or distribution 7 from within the State shall provide a notice of withdrawal in writing to the 8 Superintendent of Insurance and to the Attorney General at least 180 days prior to the 9 withdrawal. 10 C. A manufacturer or distributor of a referenced drug may not refuse to negotiate in 11 good faith with a payor or seller of prescription drugs a price that does not exceed the 12 referenced rate for that drug. 13 D. The Superintendent of Insurance shall assess a penalty of $500,000 or the amount 14 of annual savings determined by the superintendent in accordance with subsection 6, 15 whichever is greater, on any manufacturer or distributor of a referenced drug, that the 16 superintendent determines has withdrawn a referenced drug from sale or distribution 17 in the State in violation of paragraph A or B or has failed to negotiate in good faith in 18 violation of paragraph C. 19 The purpose of this Act is to protect the 20 safety, health and economic well-being of the people of this State by safeguarding them 21 from the negative and harmful effects of excessive and unconscionable prices for 22 prescription drugs. The Legislature finds that: 23 1. Access to prescription drugs is necessary for the people of this State to maintain or 24 acquire good health; 25 2. Excessive prices negatively affect the ability of the people of this State to obtain 26 prescription drugs, and price increases that exceed reasonable levels endanger the health 27 and safety of the people of this State; 28 3. Excessive prices for prescription drugs threaten the economic well-being of the 29 people of this State and endanger their ability to pay for other necessary and essential goods 30 and services, including housing, food and utilities; 31 4. Excessive prices for prescription drugs contribute significantly to a dramatic and 32 unsustainable rise in health care costs and health insurance costs and threaten the overall 33 ability of the people of this State to obtain health insurance coverage and maintain or 34 acquire good health; and 35 5. Excessive prices for prescription drugs contribute significantly to rising costs to the 36 State for health care provided and paid for through health insurance programs for public 37 employees, including employees of the State, municipalities and counties, school districts, 38 institutions of higher education and retirees whose health care costs are funded by public 39 programs, thereby threatening the ability of the State to fund those programs adequately 40 and further threatening the ability of the State to fund other programs necessary for the 41 public good and safety, such as public education and public safety. 42 Based on findings in subsections 1 to 5, the Legislature finds that excessive prices for 43 prescription drugs threaten the safety and well-being of the people of this State and finds it Page 4 - 131LR0735(01) 44 necessary to act in order to protect the people of this State from the negative effects of 45 excessive costs. 3 4 This bill requires that a state entity, health plan or participating plan qualified under 5 the federal Employee Retirement Income Security Act of 1974 may not purchase 6 prescription drugs to be dispensed or delivered to a consumer of this State at a cost that 7 exceeds the referenced rate. The referenced rate of a prescription drug is the maximum 8 rate for a drug determined by the Secretary of the United States Department of Health and 9 Human Services under the federal Medicare program. Any savings generated as a result 10 must be used to reduce costs to consumers. 1 2 4 5 6 7 8 9 10