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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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OIG Speaks out on Speaker Programs: Some Implications of the New Special Fraud Alert

Time to Read: 1 minutes Practices: Health Care

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On November 16, 2020, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Fraud Alert (“SFA”) highlighting what it considers to be fraud and abuse risks associated with speaker programs hosted by pharmaceutical and medical device companies. The SFA treads some old ground by highlighting certain conduct—such as $500-per-head meals or allowing attendees to bring social guests—that OIG has long made clear may make a speaker program suspect. But it also expresses some new and seemingly broader concerns about such programs as a general matter. This warrants a close look since OIG has addressed speaker programs in its guidance to industry and through corporate integrity agreements for nearly two decades without suggesting that speaker programs are generally of concern. In addition, since, historically, SFAs have been associated with government enforcement initiatives, and this SFA has issued on the heels of some high-profile speaker program settlements, the SFA merits close attention.

This Alert summarizes key elements of the SFA, and contains a table summarizing past SFAs and the enforcement initiatives that have been associated with them.

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