Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Drug & Device Law

OCTOBER 10, 2022

The manufacturer sought to cover Medicare patients’ Part D cost-sharing obligations for the drug – which were estimated at approximately $13,000 per year – but the OIG said “no thanks,” and the Second Circuit has affirmed that outcome. That being said, Medicare does not cover the entire cost of the drug. 1320a-7b (“AKS”).

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S.

FDA 72

FDA Fraud Governance Medicare 72