Proposed AKS rewrite on drug rebates: The impact and challenges ahead

The Trump Administration recently proposed what is arguably the most sweeping change to the regulatory safe harbors for the federal health care anti-kickback statute in decades. The proposed rule from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) seeks to fundamentally transform the ways pharmaceutical manufacturers negotiate for coverage and payment of their products with Medicare Part D plans, Medicaid Managed Care Organizations (MCOs), and their pharmacy benefit managers (PBMs). But even OIG seems to acknowledge that it is uncertain whether its proposed changes will lower list prices, curb price increases, or reduce the financial burden on federal beneficiaries and programs.

On 22 February, our team presented a complimentary webinar that discussed the proposed rule and focused on:

  • Issues that are ripe for comment;
  • The proposed rule’s impact on negotiations with Part D plans, Medicaid MCOs and PBMs; and
  • The broader implications of, and potential legal challenges to, the rule.

Click here for the webinar recording

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