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 August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more
To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more
On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more
Executive Summary- The Inflation Reduction Act (IRA) makes significant changes to the Medicare Part D prescription drug benefit and also directs the Centers for Medicare and Medicaid Services (CMS) to enforce...more
On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more
Several states are considering or have enacted legislation to create prescription drug affordability boards (PDABs)....more
On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more
Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more
F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more
On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more
The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more
On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who are unable to...more
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more
EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more
On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we see Georgia pharmacies selling medical marijuana. We have an update on the Ohio legalization ballot...more
On October 2, the Virginia Board of Pharmacy posted a general notice indicating that it had voted to rescind the request for applications (RFA) for a Pharmaceutical Processor license in Health Service Area I. The RFA will now...more
Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more
On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more