Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more
Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more
The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more
In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more
In what appears to be a response to manufacturer complaints regarding “black box” Inflation Reduction Act (IRA) drug price negotiations, the US administration issued a statement on January 29, 2025, stating it planned to...more
The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more
When Congress created the Part D benefit for Medicare beneficiaries, it also required group health plan sponsors and certain other entities to notify Medicare-eligible participants and the Centers for Medicare & Medicaid...more
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more
Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more
The rising cost of prescription drugs under Medicare continues to pose significant challenges for seniors, a population that relies heavily on consistent and affordable access to medications. This issue underscores broader...more
Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal government’s position that...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
The Inflation Reduction Act (the Act) of 2022 was controversial at the time the Act was signed into law and remains so. To date, multiple legal challenges have been asserted against the Act, with more expected in the future....more
In the wake of the biggest American political comeback in more than 100 years, stakeholders in the health industry are asking themselves: What does this portend for health policy—patients, providers, manufacturers, and...more
With President-elect Trump announced as the winner of the 2024 election, the landscape of U.S. policy is poised for potential shifts that could significantly impact the life sciences sector. To a large degree, the extent to...more
There are important new rules this year relating to prescription drug coverage which may be relevant to your Medicare plan beginning January 1, 2025. The “Open Enrollment” period this year during which eligible individuals...more
Congress may be in recess, but that has not slowed down drug pricing policy developments. In recent days, the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO) have rolled out a series...more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more
As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more
In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to...more