Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more
Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely: •the requirement that a violation of the AKS must...more
The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more