Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Measures of success: How value-based pricing may change the pharmaceutical industry
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...more
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
The Biden Administration’s Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers, has faced several legal challenges....more
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
The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which aims to lower drug prices by enabling the federal government to negotiate prices for some of the costliest Medicare Part D...more
On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more
The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more
Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more
This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more
The Inflation Reduction Act (“IRA”) was signed into law by President Biden on August 16, 2022. The expansive legislation includes key health care provisions, including drug pricing reforms, inflationary rebates, Medicare Part...more
Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more