HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
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
Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader...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
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more
Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...more
Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more
In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more
This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more
On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more
This week in Washington: The House and Senate are in recess. Congress House Senate Administration Proposed Regulations/Guidance Final Rules/Guidance Reports House Bipartisan Legislation Introduced on Accurate Provider...more
Congress - Hearings/Markups - Senate Finance Committee: "Drug Pricing in America: A Prescription for Change, Part III" - Tuesday, April 9, 2019: The Senate Finance Committee continued its drug pricing series by...more
Coming Week’s Highlights: Congress will continue to examine drug pricing; on Tuesday, the Senate Finance Committee will hold the third in a series of hearings, this one focused on pharmacy benefit managers (PBMs). The House...more
Upcoming Hearings - Tuesday, March 26, 2019 - House Committee on the Budget: “Department of Health and Human Services FY2020 Budget” - The House Committee on the Budget will hold a hearing examining the proposed...more
Upcoming Hearings - Tuesday, March 5, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?” - The Senate Committee on Health,...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II” - The second hearing in a series on drug pricing in the Senate Finance Committee...more
Upcoming Hearings - Tuesday, Feb. 26, 2019 - Senate Finance Committee: “TBA Hearing on Drug Pricing” - The second hearing in a series on drug pricing in the Senate Finance Committee will include the testimonies of...more
Last week concluded the Senate’s time in Washington prior to the lame duck session. With both the House and the Senate back home and focused on campaigning, we turn our attention to action from the Administration. As of...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
Here are some key health care policy headlines from the past week that you may have missed. Congress - Legislation and Committee Activity - Bloomberg: Opioids Compromise Already in the Works in Congress – Congress is...more
Outlook for This Week in the Nation's Capital - Appropriations. The Senate is expected to begin work this week on its next minibus appropriations bill- a package that would contain the Defense and Labor-HHS spending bills....more
On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more