On June 24, 2019, Maine Governor Janet Mills signed a four-bill prescription drug reform package into law that would allow the wholesale importation of prescription drugs, create a prescription drug affordability board, increase drug price transparency, and regulate pharmacy benefit managers.
LD 1272, An Act to Increase Access to Low-Cost Prescription Drugs
This bill sets up a wholesale prescription drug importation program once approved by the United States Department of Health and Human Services (HHS). This bill is modeled after a Vermont law that passed last year and also includes language directing the Department of Health and Human Services to consider whether the program may be developed in conjunction with other states.
The program must: designate a state agency to become a licensed drug wholesaler or contract with a licensed drug wholesaler to seek federal certification and approval to import safe prescription drugs and provide cost savings to consumers in the State; use prescription drug suppliers in Canada regulated under the laws of Canada and/or the Canadian province; ensure that only prescription drugs that meet the FDA safety, effectiveness, and other standards are imported; import only prescription drugs that are expected to generate a “substantial cost savings” for consumers; prohibit the distribution, dispensing or sale of imported prescription drugs outside of Maine; recommend a charge per prescription or other method of financing to ensure the program is adequately funded that does not jeopardize the required “substantial cost savings”; apply for and receive funds, grants, or contracts from public and private sources; and include an audit function.
The legislation directs that the Maine Department of Health and Human Services shall adopt rules to design the program no later than January 1, 2020, with the request for approval and certification of the program submitted to the U.S. HHS no later than May 1, 2020.
LD 1499 – An Act to Establish the Maine Prescription Drug Affordability Board
This piece of the law creates a Prescription Drug Affordability Board which will determine prescription drug spending targets for public entities based on a 10-year rolling average, accounting for inflation with spending reductions, and would provide methods for achieving lower prescription costs through measures such as bulk purchasing, leveraging multi-state purchasing, or negotiating specific rebate amounts.
The five-members of the Board shall have “expertise in health care economics or clinical medicine” and not be affiliated with – or represent the interests of – a public payor. Two members will be appointed by the President of the Senate, two members by the Speaker of the House of Representatives, and one member appointed by the Governor. All appointing parties shall also appoint one alternate member in the event one of their appointed members elect to be recused from conversations.
Then, starting no later than March 1, 2010, the Board shall hold public sessions at least every twelve weeks to review prescription drug information and make recommendations.
LD 1162 – An Act to Further Expand Drug Price Transparency
This piece builds upon previous legislation, authorizing the gathering of information related to the pricing of drugs all along the supply chain from manufacturers, wholesalers, pharmacy benefit managers, and insurance companies. Previously, the information was only gathered from payors and providers.
In addition, a new annual report shall be posted no later than November 1 (beginning in 2020) to the publicly available website of the organization responsible for the transparency.
The new legislation also allows for annual assessments of $500 by the organization against prescription drug manufacturers, wholesale drug distributors and pharmacy benefits managers.
LD 1504 – An Act to Protect Consumers from Unfair Practices Related to Pharmacy Benefits Management
This bill prohibits pharmacy benefit managers from retaining rebates paid by manufacturers and requires those rebates to be passed along to the consumer or the health plan.
It also requires that beginning January 1, 2020, all pharmacy benefits managers must have a license from the superintendent, which will be valid for three years thereafter. Any pharmacy benefits managers that fails to obtain a license is subject to a fine of $5,000 per day for the period they are in violation.
Summary
When signing the legislation, Governor Mills stated, “The outrageous prices of prescription drugs are hurting Mainers, especially older Mainers on a fixed and limited income. No one should have to choose between food or medicine. With this package of legislation, Maine is taking a major step forward in tackling this issue and standing up for Maine people”.
These measures are similar to actions taken in other states such as the accountability board in Maryland or reimportation law in Florida. It is worth watching to see if these measures actually save patients money or just add to the administrative burden for doing business in the state.