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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
News Briefs - Lawmakers Boosting Investigation of P.E. Role in Healthcare - Influential U.S. Senators are the latest to launch investigations into private equity's increasing role in owning and operating everything from...more
News Briefs - Appeals Court Rules Drug Firms Can Limit 340B Discounted Drugs - An appeals court has upheld a lower court ruling on 340B that sided with drug manufacturers. At issue is whether pharmaceutical companies can...more
News Briefs - Telehealth Access Challenged as Internet Subsidy Program Ends - More than 23 million low-income households -- urban, suburban, rural, and tribal -- are enrolled in the federal discount program Congress created...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
News Briefs - FDA Gives First Approval of Mass Canadian Drug Imports - The Food and Drug Administration has allowed Florida to import millions of dollars' worth of medications from Canada at far lower prices than in the...more
The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more
On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating...more
Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more
News Briefs - Drugmakers Prepare for Legal Battle Over Drug Price Negotiations - Major drugmakers have tailored a legal crusade against the Biden administration's drug price negotiation program that legal scholars say appears...more
The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more
We hope that you, like Congress, enjoyed some time off last week and are ready to dive in—for a few days at least. As we previously reminded you, the House is only in session 12 days in July, then away for August recess, and...more
Walking away from the American Health Law Association’s annual conference, I’m feeling energized from (re)connecting with friends and colleagues, inspired by the complex and transformational work being done throughout the...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
Two bills are moving in the United States House of Representatives that have implications for hospitals and health systems, with material changes proposed regarding pricing transparency requirements, identification and...more
Inflation Reduction Act and Health Reform: The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to staff the new Medicare Drug Rebate and Negotiations group and has posted various related job openings....more
We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As we wrote in an earlier Client Alert, in June 2022, the U.S. Supreme Court struck down HHS’s Medicare payment cuts to...more
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more
The United States District Court for the District of Columbia granted plaintiffs’ motion to vacate the 2022 OPPS Rule’s 340B rates on a prospective basis, meaning that HHS will pay 340B hospitals the drug’s average sales...more
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more