Stephnie John on Drug Pricing

PBM Policy and Legislative Update — Summer 2024

Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more

8/1/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Supply Chain , Telehealth , Transparency

Mintz IRA Update — Opposition to the Use of March-In Rights to Lower Drug Prices

In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more

7/16/2024 / Bayh-Dole Act , Congressional Review Act , Drug Pricing , Food and Drug Administration (FDA) , GAO , Inflation Reduction Act (IRA) , March-in-Rights , NIST , Pharmaceutical Industry , Prescription Drugs

Mintz IRA Update — Learning From Experience: Medicare Drug Price Negotiation Program Updates

Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more

7/16/2024 / American Hospital Association , Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Negotiations , PHRMA , Section 340B

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

7/16/2024 / Beneficiaries , Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Health Insurance , Health Plan Sponsors , Inflation Reduction Act (IRA) , Manufacturers , Medicare Part D , Out-of-Pocket Expenses , Reimbursements

Mintz IRA Update — The IRA in 2024: The Medicare Drug Price Negotiation Program in Full Swing and Other Developments

Our team’s preparation for the year includes a review of the anticipated impact of the IRA on the health care industry in 2024. Many of the IRA’s key provisions that go into effect this year are centered around two main...more

3/18/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Healthcare , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Negotiations , Prescription Drugs

Mintz IRA Update — Biden Administration Proposes Allowing Agencies to 'March-In' to Control Rising Drug Prices

The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more

3/18/2024 / Bayh-Dole Act , Biden Administration , Draft Guidance , Drug Pricing , March-in-Rights , Medicare , NIST , PHRMA , Regulatory Agencies

Mintz IRA Update — Second Edition: Q1 2024

Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health...more

3/14/2024 / Drug Pricing , Healthcare , Inflation Reduction Act (IRA) , Medicare , Prescription Drugs

The Supreme Court’s SuperValu Decision on the “Knowingly” Element in the False Claims Act: Protecting Against Liability When There...

In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a...more

6/15/2023 / Drug Pricing , False Claims Act (FCA) , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Scienter , SCOTUS , US ex rel Thomas Proctor v Safeway Inc , US ex rel Tracy Schutte et al v SuperValu Inc et al

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more

8/10/2022 / Anti-Kickback Statute , Biosimilars , Budget Reconciliation , Drug Pricing , Medicare , Medicare Part D , Out-of-Pocket Expenses , Pharmacy Benefit Manager (PBM) , Price Inflation , Transparency

Stephnie John

Mintz

Popular Topics by This Author

Latest Posts › Drug Pricing