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
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more
Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June,...more
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
During a second special session, the West Virginia Legislature approved House Bill 214, revising the prescriptive authority of advanced practice registered nurses (APRNs) and physician assistants (PAs). Previously, APRNs and...more
Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15 or more...more
State legislatures continue to push forward on drug pricing with legislation designed to reduce the cost of prescription drugs. Recent steps across a number of states include laying the groundwork for effective...more
Starting next summer, California licensed pharmacies offering automatic prescription refill programs will be subject to new constraints and limitations. California recently approved new Board of Pharmacy regulations, which go...more
The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued by Long Island counties Nassau and Suffolk (County Plaintiffs) in their capacities as...more
The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an...more
On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies....more
The Ohio Board of Pharmacy (OBOP) is actively working to modify its rules or formulate temporary guidance and procedures to help combat the spread of COVID-19 (coronavirus) and aid in the delivery of pharmacy care to impacted...more
It felt as if Crossover Day came early under the Gold Dome as legislators rushed to vote on a number of weighty issues today, some of which were the products of months of discussion while others appeared in only the last few...more
Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more
Underfunded pension liabilities get needed attention The topic of Vermont’s overwhelming state employee and teachers’ pension burdens rears its head on occasion, but legislators quickly move on to challenges more easily...more
Global Warming Solutions Act: asking for too much or not enough? The House Committee on Energy and Technology took testimony this week on the The Global Warming Solutions Act. University of Vermont Professor Jon Erickson...more
The 2020 Legislative Session will begin its 60-day trek to completion on Tuesday, January 14, 2020. The following is a sample of bills that have been filed. We encourage you to review these bills, and contact us with specific...more
As another mark of progress in the fight against opioid addiction, Governor Wolf signed Senate Bill 572 (the “Act”) into law on November 27, 2019, requiring prescribing providers (referred to as “Prescribers”) to take several...more
While drug pricing continues to be an important political issue in the United States, it has been state legislatures, not the federal government, that have been able to translate policy proposals into new laws. Over the...more
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs. The process for obtaining a license to distribute often requires an...more