Trump’s ‘Most-Favored-Nation’ Executive Order: Legal and Policy Analysis
“What did it cost?” “Everything.” – Thanos in Avengers Endgame Trump’s Most-Favored-Nation Executive Order is bold, sweeping legislation. It attempts to resolve that Americans paying more for drugs than patients…
What is means, is it legal and who does it effect? – Trump’s April 15 Executive Order on Drug Pricing.
Introduction In Game of Thrones, the Olenna Tyrell acknowledges that “the Starks are right eventually. Winter is coming.” That’s what this Executive Order feels like, a warning that change is…
What qualifies as a Single-Source Drug?
The full impact of the Inflation Reduction Act (IRA) will take years to understand, but manufacturers and investors are altering their market strategies as a result. One area of contention…
Patents, Market Exclusivity and Biosimiliars in Life Sciences
Introduction to Patent and Market Exclusivity in Life Sciences In the life sciences industry, patents and regulatory exclusivities are tools that protect new therapies from competitors. A patent is an…
Overview of the Anti-Kickback Statute (AKS)
The Anti-Kickback Statute (AKS) is a federal criminal law that prohibits the exchange of remuneration for referrals in federally funded healthcare programs. The purpose of the AKS is to protect…
Drug Pricing Glossary
Hi, I have multiple purposes for starting this thread. First, I want to educate the public on drug pricing. The lack of transparency in healthcare has resulted in increased prices,…
PIE Presentations (Preapproval Information Exchange)
The First Amendment permits pharmaceutical companies to portray information relating to unapproved drugs or uses as long as it is “non-misleading and truthful”. One necessary communication regarding an approved product…
Copay Accumulators
The use of copay accumulators and copay maximizers is a pressing topic in healthcare. Copay Accumulators occurs when insurers do not count manufacturer assistance (generally copay cards) towards the patient’s…
Average Sales Price (ASP)
ASP – Average Sales Price. The Average Sales Price is a formula used by Medicare to determine the price of a medication used under the medical benefit of Medicare. The…
Market Access Considerations Series – New Medical Services and New Technologies (NTAP)
New Medical Services and New Technologies (NTAP) is an additional add-on payment for new medical services and technology used in the inpatient setting. A medical service or technology can qualify…