AMCP Comment Letter on Biosimilar Interchangeability with a Biologic Reference Product

In Kennedy v. Braidwood Management, Inc., the plaintiffs challenged the constitutionality of the USPSTF, arguing that USPSTF members should be considered “principal officers” under the Appointments Clause and, therefore, must be appointed by the President and confirmed by the Senate.

As CMS explores strategies to increase the adoption of digital health tools, AMCP urges CMS to support broader coverage of prescription digital therapeutics (PDTs) under Medicare and Medicaid. PDTs represent an emerging class of software-based treatments that deliver clinically validated therapeutic benefits, either independently or in combination with other interventions. These products can play a transformative role in improving access, especially for patients with behavioral health conditions or chronic diseases.

Following House passage of congressional Republican’s budget reconciliation package, the One Big, Beautiful Bill Act (H.R. 1), Senate Republicans took to their respective committees to provide edits and changes to the massive tax-cut, border security, energy reform, and health care package.