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Prescription Drug Policy, 2021 and 2022: The Year In Review, and The Year Ahead

"This past year was filled with news in the prescription drug policy area, from the [FDA's] most controversial drug approval in many years to ongoing discussions in Congress over drug pricing reform. Through it all, the importance of responding to the COVID-19 pandemic has remained at the forefront of these challenges."

Update on Prescription Drug Legislation in Congress

"In the House of Representatives, the Democratic caucus is expected to pass HR 3 ... which contains a series of far-reaching drug pricing reforms. At the same time, the House Republican caucus introduced its own drug pricing bill [see summary and text], largely composed of smaller bipartisan elements. In the Senate, the Finance Committee released updates to its drug pricing package [see news summary and text], and the Health, Education, Labor, and Pensions (HELP) Committee reached a deal on surprise billing that includes a range of small bipartisan drug pricing elements [see summary]."

Prescription Drug Policy: The Year in Review, and the Year Ahead

"Democratic members of Congress, many of whom will now serve in leadership positions in the new Congress, have introduced a flood of bills on the topic of drug pricing.... All of these bills go beyond the comprehensive legislation already introduced by Democrats into both houses in 2017[.]"

Administration Proposes Strategies to Lower Pharmaceutical Prices in Medicare Part D

"As set out in the proposed rule, the plan has three major new provisions: [1] providing Part D plans with more flexibility to manage protected classes, [2] updating existing e-prescribing systems to make patients' costs visible when a prescription is ordered, and [3] requiring pharmacy price concessions for drugs at the point of sale."

Trump Administration Outlines Plan to Lower Pharmaceutical Prices in Medicare Part B

"The plan contains three key elements: substituting private-sector pharmaceutical vendors for the current Part B 'buy and bill' practice, changing the Part B Average Sales Price plus 6 percent reimbursement system to a flat fee, and implementing international reference pricing. The first two of these were attempted -- and failed -- in previous administrations."

Administration Finalizes Drug Pricing Rebate Rule

"There appear to be no major structural changes between the NPRM and Friday's final rule (which is now scheduled to take effect in 2022, rather than in 2020, as originally proposed). But there are at least two points worth noting about the new release.... Removing Medicaid Managed Care Organizations ... Changing course by confirming that premiums and spending will not rise ... Like the most-favored-nation rule, the release of the final rebate rule came with additional legal complications that may jeopardize its implementation."

Administration Finalizes Drug Importation Plans, But Legal and Practical Questions Remain

"[HHS] released a final rule aiming to permit states or other specific actors to establish programs to import prescription drugs from Canada. If it is not blocked in court, the rule will become effective 60 days after its publication in the Federal Register, [which is scheduled for October 1]. This rule is one element of the Trump Administration's broader agenda on drug pricing, but it faces several large obstacles which are likely to derail its implementation."

Administration Announces Plan to Permit Drug Importation

"[T]he plan relies on others -- states, wholesalers, and manufacturers themselves -- to do the federal government’s work for it, to demonstrate the potential for importation to be done safely and effectively.... [T]he state-based importation programs would be only demonstration projects, which (in addition to only applying in a geographic subset of the country) would be time-limited and require renewal."

Trump's Drug Pricing Speech Breaks Little New Ground, Largely Spares Industry

"The first immediate action calls on the FDA to 'evaluate the inclusion of list prices in direct-to-consumer advertising.' ... The second immediate action calls on [CMS] to update Medicare's drug-pricing dashboard 'to make price increases and generic competition more transparent.' ... The use of confidential rebates has become a central feature of our drug reimbursement system, and restricting or reducing their use would significantly change the ways in which drugs are distributed and reimbursed."

Administration Finalizes Most-Favored Nation Drug Pricing Rule

"Rather than depending for its success on whether private sector firms volunteer for a novel, difficult task, CMS implements the IFR through the existing buy-and-bill model. Under the IFR, providers themselves will be reimbursed for the 50 Part B drugs that are the subject of the IFR program based on the most-favored-nations price.... CMS has now expanded the scope of the program, choosing to implement a mandatory nationwide program affecting most (though not all) Medicare providers."