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
An employer health plan is the latest target of class action litigation seeking redress for the alleged conduct of the plan's pharmacy benefit manager ("PBM")....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
In a win for self-funded (i.e., self-insured) health plans subject to the Employee Retirement Income Security Act of 1974, as amended (ERISA), the Tenth Circuit recently ruled that ERISA preempts provisions of an Oklahoma law...more
The U.S. Court of Appeals for the 10th Circuit issued a sweeping decision that (1) maintains long-standing federal protections for employer and union-sponsored health plans to design their health benefit plans, including...more
The US Court of Appeals for the Tenth Circuit recently held in Pharmaceutical Care Management Association (PCMA) v. Mulready that the Employee Retirement Income Security Act (ERISA) and Medicare Part D preempted several...more
One of the more fascinating developments in group health plan law has been the growth of antitrust claims by group health plans against drug manufactures who allegedly agree to delay the production of generic drugs once a...more
In a recently decided case, Rutledge v. Pharmaceutical Care Management Association, the U.S. Supreme Court held that the Employee Retirement Income Security Act of 1974 (ERISA) does not preempt an Arkansas statute that...more
On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more
What is the Annual Maximum Out-Of-Pocket Limit (“MOOP”)? MOOP is the most a participant must pay for covered services under a group health plan in a plan year. After a participant spends this amount on deductibles,...more
Background. These days, almost all employer-sponsored group health plans require an employee (and any dependents) covered under the plan (each are referred to as a “member”) to pay “out-of-pocket” for covered expenses in the...more
On May 20, 2019, Minnesota Governor Tim Walz signed the Minnesota Pharmacy Benefit Manager Licensure and Regulation Act into law. This law aims to increase transparency regarding how drug prices are set and affords direct...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
Employers looking for greater transparency on prescription drug pricing and pharmacy benefit manager (PBM) services will soon have a powerful new tool from an unlikely source: California lawmakers. Under Assembly Bill (AB)...more
This month Richard Zall, Chair of Proskauer's Health Care Department, explores developments likely to occur with respect to the Affordable Care Act as a result of the new administration. In our Rulings, Filings and...more
As we look into our crystal balls, we do not expect a lot of new issues in 2015. Rather, we believe that most of the significant issues will be a continuation of issues that arose in 2014 or earlier. ...more
In Corber v. Xanodyne Pharmaceuticals, the Ninth Circuit – on rehearing en banc –examined the applicability of the “mass action” provision of CAFA, which provides federal jurisdiction for any civil action in which monetary...more
Even with the lingering uncertainty over Medicaid program expansion, the High Court's decision brings some certainty and the need to focus on ramifications of ACA implementation. On June 28, the U.S. Supreme Court held...more