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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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Senator Chuck Grassley Presses Comptroller General to Investigate Foreign Threats to Taxpayer-Funded Research

Time to Read: 1 minutes Practices: Health Care

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On Tuesday, Senate Finance Committee Chairman Chuck Grassley of Iowa sent a letter to the General Accountability Office asking it to examine “how federal agencies implement and oversee conflict-of-interest policies and requirements related to federally funded research,” with special attention to diversity across federal agency and nonfederal institutional research policies, including monitoring and enforcement, and requirements for disclosing foreign affiliations. The letter follows from a June Finance Committee hearing and multiple oversight letters from Senator Grassley in the last year, all focused on foreign threats and perceived threats to research funded by federal agencies like the National Institutes of Health, the National Science Foundation, and the Department of Defense, among others. Of note, and as is common in these types of GAO request letters, there is a specific request for GAO to consult stakeholders, including research institutions and principal investigators, to learn their views about “options to strengthen federal agencies’ and nonfederal institutions’ ability to identify and address foreign threats to federally funded research.” For example, the letter asks about the possibility of making “changes to grant forms that place more responsibility for financial disclosures on principal investigators.”

While GAO is not legally bound to begin this inquiry, it may be expected to do so given the source of the request and the timeliness of the topic. Notwithstanding this uncertainty, and the fact the GAO reviews can often take years to complete, universities, academic medical centers, and others receiving federal research dollars should be aware of the request and attend to its terms and progress, and to the Senate’s interest in the topic. For example, the reference to changing grant forms to place more responsibility on PIs signals current thinking on actions that Congress might take to address its concerns about undue foreign influence in taxpayer-funded research.

The letter and press release describing it can be found here.

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