Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2028 of the Drug Price Negotiation Program (DPNP) established by the Inflation Reduction...more
On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more
2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more
Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more