Stephnie John

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7/16/2024  /  American Hospital Association , Centers for Medicare & Medicaid Services (CMS) , Draft Guidance , Drug Pricing , Inflation Reduction Act (IRA) , Medicare , Negotiations , PHRMA , Section 340B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