News & Analysis as of

Inflation Reduction Act (IRA) Medicare New Legislation

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

DLA Piper

Keeping Watch on the IRA: Co-pays Increasing for Diabetes Medications

DLA Piper on

The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

Brownstein Hyatt Farber Schreck

Reflections on the Inflation Reduction Act’s Pill Penalty

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

King & Spalding on

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

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

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

Epstein Becker & Green

More Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act

Epstein Becker & Green on

On August 16, 2022, President Biden signed into federal law the Inflation Reduction Act (IRA), which, among other priorities for the Biden administration, addresses prescription drug costs and drug prices in the Medicare...more

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