Transparency’s Uncertain Future

I just returned from speaking at CBI’s 10th Annual Forum on Transparency and Aggregate Spend.  After 10 years and 3 CMS Open Payments reporting cycles, I’m struck by how uncertain the once bright future of the Sunshine Act is.  Overall, the industry remains mired in a transactional mud under increasingly gray skies. Too many companies still obsess about putting the right transaction (or transfer of value or (ToV)) into the right…

CVS, Opioids & Lack of Compliance

The Year of the Pharmacy continues as CVS again makes negative headlines involving opioids.  This time, a pharmacist in Georgia is accused of stealing more than 3,000 pills from them including oxycodone, morphine, Dilaudid, and Adderall.[1]   Inflaming matters, the pharmacist allegedly stole the narcotics by ingesting them in the store – on camera.    The theft was discovered only when a new pharmacist found empty bottles.  Bottles that the store’s…

Upping the Ante – FCA Penalties Double Today

Today is the first day of August and the start of high vacation season.  For compliance officers, however, there is no holiday.   As of August 1, 2016, the U.S. Department of Justice (DOJ) has now doubled the penalties for False Claims Act (FCA) violations from between $5,500 to $11,000 per claim to $10,781.40 and $21,562.80 per claim.  Of course, the threat of triple damages remains in place. Announced back in June…

The Government Doesn’t Have to Win to Inflict Pain

Since the recent publication of the so-called Yates memorandum [1] setting out the Department of Justice’s (DOJ) strategy of targeting individuals for prosecution, we’ve seen several recent cases where the Government has not secured a conviction.[2]  For some companies, this has strengthened their resolve to resist instituting a compliance program. However, I can relate from personal experience working at a company under Government indictment that the DOJ doesn’t need to…

Med-Tech Compliance Comes of Age

It is no secret that compliance programs in many med-tech companies lag behind current compliance best practices.  There are many possible reasons for this: Life Science compliance is dominated by pharmaceutical settlements. The pharmaceutical regulatory scheme is more established (1938 vs. 1976). Medical technology companies have fewer resources overall. Regardless of the reason, 2 recent cases  (Olympus and Invacare) and a McKinsey study clearly demonstrate that med-tech companies can no longer…