The Road to Regulation: Vehicle Service Contracts Explained — Moving the Metal: The Auto Finance Podcast
Money-Saving Licensing Tips for Startups
A Discussion with Nacha on Proposed Rulemaking Regarding Fraud - Payments Pros: The Payments Law Podcast
CFPB's Section 1071 Final Rule (Part 3): Potential Problem Areas – The Consumer Finance Podcast
Consumer Finance Monitor Podcast Episode: Perspectives on Counseling on the Creation of Consumer Finance Products, with Guest Joseph Schuster, Managing Director and Senior Counsel, Goldman Sachs
Consumer Finance Monitor Podcast Episode: Recent Federal and State Debt Collection Developments
Medical Spa Start-Ups: What Providers Need to Know
Patent Licensing Tips and Takeaways
A Changed Legal Landscape? Analyzing California’s New Cannabis Laws
Obtaining a Recreational Marijuana License from Your Local Municipality
Mergers and Acquisitions in Healthcare: Getting Your House in Order
Nota Bene Episode 72: Space Law: License, Launch, Finance, Insurance, and Responsible Space Stewardship with Brian Weimer
Meritas Capability Webinar - Legal Cannabis and the Health Care Industry
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more
We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more
Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more
Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
Following the release of a memo last month detailing upcoming regulations, the Massachusetts Board of Registration in Pharmacy released its long-awaited regulatory changes for non-resident pharmacy licensure last week by...more
Until recently, Massachusetts was the only state that did not maintain a licensing regime for nonresident pharmacies (i.e., out-of-state pharmacies shipping drugs into the state). On December 6, 2024, the Massachusetts Board...more
On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more
On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more
The Massachusetts Board of Pharmacy (Board) announced in September 2024 that it would soon require licensure for all nonresident pharmacies to dispense prescriptions, including sterile and nonsterile compounded products, to...more
On November 12, the Kentucky attorney general (AG) issued a formal opinion, concluding that the Kentucky Board of Pharmacy lacks the authority to regulate nonresident pharmacists beyond what is specified in KRS Chapter 315....more
The Kentucky Attorney General published a formal opinion yesterday confirming that the Board of Pharmacy cannot require the licensure of pharmacists who reside outside of the Commonwealth of Kentucky. The proposed...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
The West Virginia Office of the Insurance Commissioner (“WV OIC”) recently took regulatory actions against four unaffiliated Pharmacy Benefit Managers (“PBMs”) that were operating in West Virginia without a PBM license. These...more
On Monday, May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed Judge Lewis Liman’s decision dismissing Plaintiffs’ reverse payment class actions for failure to state a claim. In re Bystolic Antitrust...more
On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more
In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...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
On September 18, 2023, the Florida Office of Insurance Regulation (“OIR”) published proposed rules to implement provisions of the Prescription Drug Reform Act (Florida Senate Bill 1550) governing Pharmacy Benefit Managers...more
Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more
Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any...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
Florida OIR Issues Informational Memorandum OIR-23-04M to PBMs - On July 19, 2023, the Florida Office of Insurance Regulation (“OIR”) issued Informational Memorandum OIR-23-04M (“Memorandum”) to Pharmacy Benefit Managers...more
On May 3, 2023, the Florida governor signed a comprehensive law (SB 1550) regarding pharmacy benefit managers (PBMs). This new law imposes significant new requirements on PBMs. This article discusses only one of these new...more