Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more
CONGRESS - Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are...more
This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more
This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024...more
This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...more
Upcoming Hearings - March 15 - Senate Committee on Veterans’ Affairs Hearing: “Examining the Future Path of VA’s Electronic Health Record Modernization Program” - 3:30 p.m., Dirksen Senate Building 106...more
This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more
This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...more
This Week in Washington: 118th Congress begins, House finally chooses Speaker...more
The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more
In regular places, when alarms blare and it becomes clear that a big, important something is broken and threatens folks’ well-being, those with common sense race to make needed fixes. Washington, D.C., is different....more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
Congress - The House and Senate are in recess for Memorial Day. House - Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more
Upcoming Hearings/Markups - January 11 - Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response” 10:00 a.m....more
Upcoming Hearings/Markups - November 2 - House Veterans’ Affairs Committee, Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs...more
This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more
This week in Washington: Senate passes infrastructure bill; Senate passes budget resolution with reconciliation instructions; Congress enters recess with House members to return Aug. 23....more
Congress - House and Senate are in recess for two weeks. Senate - Brooks-LaSure Confirmed as CMS Administrator - On May 25, the Senate voted 55-44 to confirm Chiquita Brooks-LaSure as the Centers for Medicare...more