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 January 16, 2023, the Department of Health and Human Services (“HHS”) dropped its appeal of the U.S. District Court for the District of Columbia’s September 29, 2023 decision that vacated a portion of the 2021 Notice of...more
The Department of Health and Human Services (HHS) revisited the treatment of prescription drug manufacturer coupons in a proposed rule, published on February 6, 2020, that could be welcome news for employers that have been...more
Seyfarth Synopsis: Recently, the Trump Administration issued its proposed Notice of Benefit & Payment Parameter for 2021 regulations....more
HHS recently issued its proposed Notice of Benefit and Payment Parameters (“NBPP”) for the 2021 calendar year. The 2021 Proposed NBPP allows health plans, including self-insured group health plans, to voluntary count the...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
In ACA FAQ Part 40, HHS, IRS and DOL (the "Departments") delayed the implementation of the controversial rule in HHS 2020 Notice of Benefit and Payment Parameters requiring health plans to credit to the out-of-pocket maximum...more
In our last blog past, we discussed the recent rule finalized by Health and Human Services regarding the calculation of the annual cost-sharing limits for health plan participants who receive financial assistance from drug...more
The Department of Health and Human Services (“HHS”) recently finalized a regulation (the “Regulation”) that informs employers how group health plans may account for drug manufacturer coupons for purposes of the Affordable...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
In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...more
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more