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Public comments prompt drug affordability board to rework proposed rules

Maryland’s Prescription Drug Affordability Board will create new draft regulations following written comments from the public. Photo by Joe Raedle/Getty Images.

Maryland’s Prescription Drug Affordability Board will issue revised proposed regulations meant to guide the panel’s work on making some medications more affordable, following criticisms and feedback during a public comment period, according to Andrew York, the board’s executive director.

During a Monday virtual meeting, York said a new draft will be released after a dozen “really great” written comments from various members of the medical community were submitted to the board, including concerns that the original proposed rules were too vague and didn’t seek enough input from the public.

“I can say some key themes that we saw were that many commenters would like to see some additional guidance and specificity in the regulations whenever we can provide it,” he said.

“Also, there was a lot of feedback just ensuring that we have high quality data that we’re using and considering,” he said, “and a lot of requests for opportunities for public feedback and input throughout the process for identifying drugs for eligibility and selection of the drugs and the actual cost review itself.”

The initial proposed rule was issued to set up a framework for how the board would evaluate and determine whether there are prescription medications that could be more affordable to Marylanders.

But the term “affordable” was a regular criticism among the public comments, among other concerns, as it was not clearly defined in the proposed rules.

The Maryland Tech Council, which wrote to the board on behalf of their members in the life science and biotech industries, believed that the language in the initial proposed rules was vague, and “thus subject to interpretation and unpredictable outcomes.”

“For example, the term ‘affordability’ that is used throughout the draft regulations is vague and without a definition. This could lead to a great deal of latitude among regulators on what is considered affordable and thus subject to price controls contemplated by the Board,” according to Kelly Schulz, CEO for the Maryland Tech Council, in a written comment to the board.

Maryland Healthcare for All recommended that the board make a strong effort to ensure that Marylanders who are affected by the cost of prescription drugs are heard during the board’s deliberations.

“We feel there is opportunity for more patient-centric input collection in this process,” wrote Catherine Kirk Robins, deputy director for the group.

She elaborated: “Beyond looking at prices for the product, rebates, and copay/coinsurance amounts, it would be beneficial for the Board to hear directly from patients who use the prescription drug product. We would encourage that the process includes a public hearing that is specifically designed to help the Board engage with patients, providers, and advocacy groups regarding the prescription drug product, beyond the standard open meeting.”

The Partnership to Improve Patient Care specifically highlighted a need to hear from and engage with disabled Marylanders.

“We were particularly disappointed that the draft proposed regulations did not outline a robust process for engaging patients and people with disabilities,” Tony Coelho, chairman for the organization, said in the written statement. “Engagement should happen early and often, including roundtables with affected patients and people with disabilities related to the treatments being considered by the Board, and concerted efforts to engage with diverse communities, especially those not represented in the data.”

The board’s next meeting will be in June 26, but it is not clear when the draft rules will be published or reconsidered by the board.

“Our intention is to publish another draft of these regulations in the foreseeable future,” York said Monday.

The board did approve a set of rules that set up how the group will comply with Maryland’s Public Information act, setting up fees and procedures for documents requested under the act.

The Prescription Drug Affordability Board was created as a product of 2019 legislation sponsored by Del. Joseline Peña-Melnyk (D-Prince George’s and Anne Arundel). Maryland was the first state to create a board for that purpose, and since then half a dozen other states have established similar boards or councils, according to the National Conference of State Legislatures.

But Maryland’s board has been slow to begin operating, due in part to a veto by former Gov. Larry Hogan (R) in 2020 of a bill that would have funded the board’s work.

Gov. Wes Moore (D) signed additional legislation this past session that reaffirms the board’s authority to issue upper payment limits and extends deadlines from the earlier law.

By establishing an “upper payment limit” that state and local government health plans can be forced to pay to provide those drugs to their employees, advocates hope the board will be able to bring down costs for all Marylanders.

The General Assembly also carved out an additional $1 million for the board from the 2024 state budget during the past session to help jumpstart its operations.


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Public comments prompt drug affordability board to rework proposed rules