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
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
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
The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....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
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
This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more
Welcome back. This week, the Senate Finance Committee is set to meet privately to discuss the drug pricing legislation being developed by the committee. All signs point to a deal being close with a few outstanding provisions,...more
We are a few legislative days from the Memorial Day recess with the trajectory of issues like drug pricing and surprise medical billing still emerging. The House has passed several drug pricing bills in the past month, with...more
The long-awaiting safe harbor proposed rule was published last week as the Administration looks to get out in front of the drug pricing debate that is sure to shape the 116th Congress. Under the proposed rule,rebates offered...more
In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more
This week, President Trump will go before Congress for his first State of the Union address. Will it be olive branches or brickbats? The next deadline for a government-funding bill is February 8th, a week from Thursday. Will...more
The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more
The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more
On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more
On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more
After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more
For many months, we have been speculating about how the results of the 2016 presidential election would impact employee benefits policy going forward. Now that Donald Trump has won the election and Republicans have secured a...more
Regardless of the 2016 general election outcome, a new administration will have to respond to pressing policy issues that will shape continued transformation of the U.S. healthcare system. What are the issues and where do...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more
A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more