The PharmaCertify™ Team

Fore! Even for the casual golf fan, the U.S. Open offered moment-to-moment nail biting action over the weekend. The greens at Merion offered twists and turns the golfing world will be discussing for months to come. When a major ends with all of the participants, including the winner, being under par, the course indeed had the last laugh. As the pros are left wondering what happened to their razor sharp instincts and trusty putters, we clear the fairway for another week of busy compliance news.

The lie…rather important in golf, and not a good idea when testifying before the grand jury, as a Virginia doctor discovered. The doctor was indicted for lying to a grand jury during an investigation into a case involving Orthofix and the illegal marketing of a bone growth product. Prosecutors say the doctor lied about falsifying medical records in order to justify Medicare reimbursement for procedures using the company’s bone growth stimulators.

As we witnessed over the weekend, golfers need to take whatever risk is needed when the tournament is in jeopardy on the back nine. For pharma and med device companies, FCPA risk is an inherent part of the clinical trials process. Nearly 75% of clinical trials occur overseas, and the physicians conducting the trials are often considered foreign officials under the FCPA. Due diligence of those CROs bring used to manage trials is critical to keep the risk of bribery low.

Are governments “laying up” in their anti-corruption efforts? According to the World Bank Institute, worldwide bribery amounts to one trillion dollars every year. Enforcement tends to focus on the corporation paying the bribe, which is the easier, safer and more immediate solution to deal with the problem. What about the person accepting, or soliciting the bribe? More often than not, companies are not offering bribes outright, but are having the bribes coerced from them in order to conduct business in a specific area. The International Anti-Corruption Resource Center (IARC), a non-profit organization, is providing training to local law enforcement and investigatory agencies to help spot issues like bid rigging.

It was a good day for Britain on Sunday when Justin Rose claimed the U.S. Open title. The news hasn’t been quite so good for British drug maker GSK though. The company is investigating allegations that doctors in China were paid to prescribe its drugs. An anonymous source informed the GSK board that doctors were offered cash, speaking fees, expensive dinners and travel in exchange for writing prescriptions. GSK says it has spent four months investigating the allegations and company officials have yet to find any evidence of bribery.

India may not be on the leader board when it comes to transparency in physician-industry relationships. While the U.S. and France have transparency laws in place, and countries such as Belgium and Slovakia, are in the process of passing transparency laws, India’s government has ignored recommendations from doctors and a parliamentary health committee to implement a law.

Medicines Australia’s Transparency Working Group is dealing with a deep divide as it develops a transparency program. There are two programs under consideration; one is similar to the Sunshine Act, with payments over $10 having to be reported and a $100 threshold for smaller payments; the other would require payments over $25 to be reported and no threshold for smaller payments. Supporters of the more stringent requirements say even the lower value payments can create a sense of reciprocity or obligation for the physician. Those supporting the less stringent requirements say the $10 threshold will require companies to implement new systems to capture the data, while current systems could handle the $25 threshold.

The New England Journal of Medicine recently teed up a couple of articles about the Sunshine Act. The first was authored by the architects of CMS’ National Physician Transparency Program. It provided information about the requirements of the law and suggested physicians help manufacturers in the reporting process by tracking payments themselves and providing companies with their NPI and state license numbers. In the second article, the authors claim the Act may not regulate the provision of payments to physicians, but it will change behavior by showcasing potential conflicts of interests. Further, the law will provide a “free flow” of information related to healthcare costs, which will be of benefit to the government and to private payers.

As we head to the clubhouse, you may have noticed that transparency is certainly the topic of the week. With Sunshine Act data collection set to begin in just a few weeks, now is time to train sales reps, research personnel and others who interact with physicians. PharmaCertify’s off-the shelf eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers topics like reportable expenditures, food and beverage, and the process for data review. As with our entire suite of compliance-focused training, the Sunshine Act module is easily customized to incorporate your policies and procedures.

Have a great week everyone!