California recently passed two bills with significant implications for pharmaceutical manufacturers: one imposing prescription drug price transparency requirements and another prohibiting certain types of co-pay coupon and other prescription drug discounting programmes that lower patient cost-sharing amounts for prescription drugs.
The US Office of Inspector General recently finalised two key proposed rules. The first relates to the civil monetary penalties and exclusion statutes, and the second amends the safe harbours to the Anti-kickback Statute and the definition of 'remuneration' under the beneficiary inducements civil monetary penalty.
The Centres for Medicare and Medicaid Services (CMS) recently issued frequently asked questions (FAQs) regarding the Covered Outpatient Drug Final Rule and a state Medicaid director letter. The FAQs address topics such as calculating the average manufacturer price, determining the best price, the treatment of line extensions and the setting of state reimbursement rates.
The Department of Justice recently (DOJ) filed a False Claims Act suit against Reliance Medical Systems, LLC. The medical device industry should follow Reliance closely as it might either signal the start of an enforcement trend against physician-owned distributors (PODs) or simply reflect an action targeting a network of PODs that allegedly paid particularly lucrative profits to physicians.