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
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
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
Over the past several years, legislators across the country have focused their attention on Pharmacy Benefit Managers (PBMs) due to concerns expressed over a variety of industry practices. To date, there has been legislation...more
While the sweltering roil of temporary regulatory changes related to the COVID-19 pandemic may have cooled and the initial burst of SECURE 2.0 steam begins to dissipate, sponsors of employee benefit plans should keep their...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
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
Last month, in HIV and Hepatitis Policy Institute et al v. HHS, Case No. 1:22-cv-02604-JDB (D.C. Sept. 29, 2034), the U.S. District Court for the District of Columbia struck down a Department of Health and Human Services...more
We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more
The House and Senate were both in session this week, with healthcare activity continuing at the committee level. The House Energy and Commerce Committee held hearings on the Pandemic and All Hazards Preparedness Act (PAHPA)...more
Released on March 9, 2023, President Biden’s proposed fiscal year (FY) 2024 budget focuses on existing healthcare initiatives while attempting to lower healthcare costs with an emphasis on prescription drug prices, seeking to...more
Today, Thursday, March 9, President Biden unveiled his Fiscal Year (FY) 2024 budget request, the third of his presidency. The $6.1 trillion proposal calls for $1.9 trillion in discretionary spending and $4.2 trillion in...more
This year, Foley’s Health Benefits Practice has released multiple alerts on several of the new group health plan requirements set forth by the Consolidated Appropriations Act of 2021 (CAA) and the Transparency in Coverage...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more
On August 16, President Biden signed into law the Inflation Reduction Act of 2022 (P.L. 117-169; the “Act”). Although the Act differs considerably from the wide-ranging domestic economic package Democrats had initially...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
House Passage and President Biden’s Signature Expected This Week - On Sunday, August 7, following an all-night voting session, the Senate approved the Inflation Reduction Act (IRA) by a vote of 51-50. The IRA was...more
Outlook for This Week in the Nation’s Capital - Congress. After a busy weekend voting on the reconciliation bill, the Senate is now in recess through Labor Day. The House, in recess since late July, returns this week on...more
Following 15 hours of debate and votes, the U.S. Senate passed legislation this weekend tackling inflation, climate change, and health care. The Senate approved the Inflation Reduction Act on a 51-50 party-line vote,...more
On August 7, 2022, the Senate passed the Inflation Reduction Act (the Act), which is expected to have a significant impact on climate, tax and health care policy in the United States. The result of intense negotiations among...more
The U.S. Senate on Aug. 7, 2022, passed the Inflation Reduction Act of 2022 (IRA). This comprehensive legislation is the result of many months of negotiations among Democrats to advance some of President Joe Biden's highest...more
On Wednesday July 27, 2022, Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) reached a deal on The Inflation Reduction Act of 2022, which proposes to raise $739 billion in revenue to be invested in...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. This week's topics include: ...more