James Ravitz on Drug Pricing

HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

9/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program

Almost 11 months after President Biden signed the Medicare Drug Price Negotiation Program (“Negotiation Program”) into law, the Centers for Medicare and Medicaid Services (CMS) has issued revised guidance that clearly details...more

7/13/2023 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

U.S. Supreme Court Closes Door on Objective Reasonableness Defense in Healthcare False Claims Act Cases

Leaves Window Open for Defense Based on Subjective Belief - On June 1, 2023, the U.S. Supreme Court issued a decision in a consolidated appeal of two healthcare qui tam cases that removes a very powerful defense from...more

6/9/2023 / Drug Pricing , False Claims Act (FCA) , Healthcare , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Reasonable Interpretations , Safeco , Safeco Insurance Co of America v Burr , Scienter , SCOTUS , US ex rel Thomas Proctor v Safeway Inc , US ex rel Tracy Schutte et al v SuperValu Inc et al

CMS Begins Implementation of the Inflation Reduction Act: Medicare Issues List of Drugs and Biologics Subject to Inflation Rebates

The Inflation Reduction Act of 2022 (Public Law 117-169) (the Act) contained an array of novel prescription drug provisions, which we described in our August 29, 2022, alert. On Wednesday, March 15, 2023, the Centers for...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Inflation Reduction Act (IRA) , Medicaid , Medicare , Medicare Part B , Medicare Part D , Prescription Drugs , Tax Credits

Prescription Drug Provisions in the Inflation Reduction Act of 2022

The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more

8/30/2022 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Prescription Drug Provisions in the Build Back Better Act

Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation - Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...more

1/11/2022 / Biden Administration , Drug Pricing , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry , Prescription Drugs

Administration Issues Executive Order on Medicare Drug Pricing Which Attempts to Impose Price Controls on Drugs Purchased by the...

Yesterday, the President issued an executive order (EO) on drug pricing for pharmaceuticals covered under Medicare parts B and D. The EO, in essence, proposes a form of price controls for drugs covered under Medicare parts B...more

9/15/2020 / Drug Pricing , Executive Orders , Healthcare Costs , Medicare , Pharmaceutical Industry , Prescription Drugs , Trump Administration

James Ravitz

Wilson Sonsini Goodrich & Rosati

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