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
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more
Congress is back from a long August recess. However, it is only back for a few weeks. During this window, there is only one major thing Congress must do: extend government funding past the September 30 deadline through a...more
Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more
CMS Finalizes New TCET Pathway. The final procedural notice, effective immediately, creates a new pathway that uses existing national coverage determination and coverage with evidence development (CED) processes to expedite...more
House Oversight and Accountability Committee Holds Hearing on PBMs. Republicans and Democrats shared concerns about the role and practices of PBMs. While generally supportive of free market principles, Republicans criticized...more
Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...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
Congress is in session for three weeks in June and also will be session for three weeks in July before the August recess. This week we continue to see committee activity examining various aspects of the healthcare space....more
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more
House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar...more
PARTIAL SNOW DAY, PARTIAL SHUT DOWN? Much of the federal government is closed today because of yesterday’s significant (for DC) and unexpected snowfall. However, part of the federal government is set to shut down this...more
On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more
Limited Time Before the End of the Year and January 19 First, welcome back from what was hopefully a wonderful and restful Thanksgiving break. Although this year will not entail a year-end government funding package, we are...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
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...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
Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more
Regular folks have known it, chapter and verse, forever. They experience it every time they pay for their prescription drugs. But Democrats in the U.S. House report in a 269-page study that they have spent three years on,...more
Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more
On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
Last Friday, President Trump signed into law two bipartisan legislative packages that included all twelve Fiscal Year 2020 funding bills. Comprehensive surprise billing and drug pricing legislation were not included in the...more
In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more