News & Analysis as of

Pharmaceutical Industry Fair Market Value

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

King & Spalding

DOJ Increases Scrutiny of Arrangements with EHR Vendors: What the ModMed Settlement Means for the Life Sciences Industry

King & Spalding on

On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more

Bass, Berry & Sims PLC

Special Fraud Alert: Speaker Programs – If It's Too Good to Be True, It Probably Is

Bass, Berry & Sims PLC on

On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more

Bradley Arant Boult Cummings LLP

OIG Takes Aim at Speaker Programs in Special Fraud Alert

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more

Cooley LLP

Blog: New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

Cooley LLP on

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became...more

Mintz

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

Mintz on

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

McDermott Will & Emery

Applicability of the Entire Market Value Rule in Hatch-Waxman Cases - AstraZeneca AB, et al. v. Apotex Corp., et al.

Addressing damages issues in the Hatch-Waxman context, the U.S. Court of Appeals for the Federal Circuit provided important guidance regarding the application of the entire market value rule to pharmaceutical sales, and the...more

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