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
On May 15, 2024, the Federal Trade Commission Chair Lina M. Khan appeared before the House Appropriations Subcommittee on Financial Services and General Government to discuss the agency’s FY 2025 budget request and ongoing...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
Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more
On August 10, 2021, the Senate passed H.R. 3684, a roughly $1 trillion infrastructure bill (the “Infrastructure Bill”) that authorizes funds for federal-aid highways, transit, broadband access and other infrastructure...more
CMS Releases Proposed Physician Fee Schedule for 2022: On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released the proposed Physician Fee Schedule (PFS) for 2022 (link). Among other issues, the PFS...more
Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Thursday's Report: Moderna...more
In Washington: Senate Parliamentarian Elizabeth MacDonough has ruled that the Senate can only discharge one more automatic budget reconciliation this year, upending Democrat’s strategy to sidestep Republicans in advancing...more
Today, Friday May 28, President Joe Biden unveiled his Fiscal Year (FY) 2022 budget request, the first of his presidency. The $6 trillion proposal calls for $1.7 trillion in discretionary spending and $4.0 trillion in...more
As we begin a new year and the second session of the 116th Congress, ML Strategies is pleased to share some highlights of where we see action this year on Capitol Hill. Although the impending impeachment trial of President...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
The congressional spending bill for 2020 will be released today. Reports indicate that the bill will permanently repeal three separate taxes originally implemented by the Affordable Care Act (ACA). All three of the taxes are...more
Congress returns to D.C. this week for a short three-week sprint to a series of important deadlines on September 30. Chief among them is funding the federal government for Fiscal Year (FY) 2020 which begins on October 1,...more
Amazon announced this week that it will spend $700 million to retrain a third of its US workforce to adapt to the increasing amount of robotic and automation technology in its warehouses. The 6-year effort will eventually...more
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
At a time when Americans experience high anxiety and financial insecurity due to medical costs — with more than 20 percent of those with health insurance experiencing trouble paying for necessities, more than a quarter of...more
Outlook for This Week in the Nation's Capital - Recess. The Senate recessed last week after leadership reached an agreement to accelerate consideration of multiple juridical nominations in order to depart two weeks earlier...more
Outlook for This Week in the Nation's Capital - Kavanaugh Vote. The Senate was previously planning to tee up the final vote on Kavanaugh over the weekend, but the vote on the floor has been delayed a week to accommodate a...more
Outlook for This Week in the Nation's Capital - Senate Appropriations. The Senate is planning to begin work today on its minibus package that contains the defense and labor, health, and education appropriations bills. ...more
Outlook for This Week in the Nation's Capital - Senate Appropriations. This week, the Senate will continue debate on the minibus containing the Interior-Environment, Financial Services, Transportation-HUD and Agriculture-FDA...more
Foley’s Bipartisan Public Policy Team is pleased to share our “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. *Please note that we publish this newsletter only...more
Washington saw a flurry of bipartisan activity over the last few weeks. Most notably, Republican and Democratic negotiators reached a long-awaited deal on sequestration budget caps. The compromise, announced on February 7 as...more
Outlook for This Week in the Nation's Capital - Recess Week. Both the House and Senate are in recess this week. Opioid Legislation. Majority Leader McCarthy has said that the House is planning to consider its expansive...more