News in Review, August 11, 2015

Industry support of CME increases in 2014,  NuVasive settles False Claims charges while Mead Johnson deals with FCPA charges, and Amarin wins a preliminary injunction in its off-label case against the FDA.

The dog days of summer have certainly arrived in most of the U.S. with temperatures that are best described as hot, hot, hot! Thanks to Willis Carrier and his wonderful invention, we can at least find occasional respite from the sun’s rays and the humidity. So while you wait for a break in the heatwave, crank the A/C up a few notches, grab a cool beverage, and just chill with this edition of the Compliance News in Review.

According to a report from the Accreditation Council for Continuing Medical Education (ACCME), industry support of CME increased 2.4% in 2014. According to the report, industry support represented about a quarter of all CME revenue in 2014, whereas in 2007, that support was closer to half (46%) of CME revenue. Physician attendance at CME dropped by just over one percent, but non-physician attendance rose six percent.

The heat is off for NuVasive now that it has settled with the DOJ. The company has agreed to pay $13.5 million to settle charges it violated the False Claims Act by marketing a product for surgical uses for which it was not approved. According to the government, the company marketed its CoRoent System for several spinal surgical procedures for which it was not approved. The DOJ also claimed kickbacks, in the form of speaker fees honoraria, were paid to induce physicians to use the system. The company was also accused of paying kickbacks for physicians to attend events hosted by Society of Lateral Access Surgery (SOLAS), an organization that was entirely organized and funded by NuVasive.

Mead Johnson entered into a settlement with the SEC to resolve charges it bribed Chinese government healthcare workers to recommend its infant formula, in violation of the FCPA. According to the SEC, the company funded the payments through distributor allowance funds paid to a third-party distributor, and then directed the third-party on how those funds were to be used. Allegedly, the payments were not properly reflected in the company’s books and records.

Insys also finds itself in the doghouse; or in this case, we’ll say the duck house (okay, it’s a reach, but stay with us here). Insys Therapeutics has entered into a settlement with Oregon to resolve a deceptive marketing case. The State claims the company marketed an opioid painkiller for treating mild pain that was only approved for treating pain in cancer patients who are not responding to other types of painkillers. The State also claims the company paid physicians for writing prescriptions and used unqualified physicians to promote the product. The settlement will be split between the State and an organization dedicated to the prevention of opioid abuse, which will be selected by Oregon’s Attorney General.

So it appears, this off-label promotion dog can hunt. Amarin, the company suing the FDA over its ability to promote its fish-oil drug for off-label uses, has won a preliminary injunction against the agency. The injunction is not a final order, but for now, the FDA cannot prevent Amarin from the truthful off-label promotion of its product. The drug is approved for treating patients with very high levels of triglycerides. Amarin would like to promote the drug for use with patients that have moderately elevated triglycerides levels, despite being on a statin.

Like the Caronia decision before it, the Amarin case certainly raises interesting questions about the future of truthful off-label promotion. While a compliance training session may not be the place and time to delve into a discussion of that future, the decision does present an opportunity to discuss off-label promotion and how to address questions related to off-label use. Why not take this opportunity to launch refresher training, or distribute an updated, quick-reference communication piece? On-going reminders about what constitutes off-label promotion, and the policies your organization has in place to address unsolicited questions, are part of any effective compliance curriculum. The case also creates an opportunity to work with commercial team managers on a plan to increase the dialogue about the topic with their teams. Off-label is in the news and the training opportunities abound.

Compliance News in Review, August 3, 2015

There was a rare occurrence in the skies this weekend. Hopefully you weren’t  standing alone without a dream in your heart when it happened, but if so, there’s a wonderful song by The Marcels that can be your soundtrack. The end of July marks the appearance of the Blue Moon.  Despite having a color in its name, the moon will not actually appear blue.  There is some dispute within the scientific community as to what constitutes a blue moon, but the criteria applying to the upcoming event is the second full moon to occur during one month. If you happened to have miss it, you won’t have to wait too long for the next one; just two and a half years. While you reflect on this somewhat rare occurrence, let us supply you with some reading material – this week’s News in Review.

We’ll start out this week’s news with a story not about the moonlight, but the Sunshine. CMS is seeking public comments about whether to add Open Payments data to individual physician pages on the Physician Compare website. CMS says this data is “of great interest to consumers,” and that consumers have indicated having this data available on Physician Compare website would “increase their ability to find and evaluate the information.” Comments must be submitted by September 8.

There isn’t much moonlight this time of year in Iceland, which is appropriate considering the Sunshine the industry association in the country has decided to spread around. The Icelandic Association of the Pharmaceutical Industry, Frumtök, has decided to adopt the EFPIA Disclosure Code. Frumtök is not a part of EFPIA, but previously adopted the EFPIA HCP Code. The head of the association says adoption of the Disclosure Code is on track, and questions have been raised by healthcare professionals, but overall there is support from national hospitals and the Icelandic Medical Association.

A National Health Service (NHS) spokesperson is howling at the moon about payments to NHS staff. A recent investigative report in the British paper, The Telegraph, showed that NHS staff were receiving payments from drug companies in an effort to persuade health care professionals to use specific drugs. According to the report, staffers served as consultants who were paid up to $23,000 to set up advisory boards at lavish hotels, often in foreign countries. NHS staffers that attended an advisory board in Germany told The Telegraph they reported the trip and payments received for their attendance, and were not involved in the decision to move to the drugs discussed at the meeting. A spokesman for the NHS said the situation was quite serious and there would be investigations into each allegation in the news report. Citing the U.S. Sunshine Act, the spokesman suggested the U.K. may want to consider creating a disclosure law. A spokeswoman for the Association of the British Pharmaceutical Industry said the industry works well under self-regulation, and would prefer to provide greater transparency under the that paradigm rather than under a law.

Cephalon may be feeling a bit blue after a recent court decision in a False Claims Act case. In a recent False Claims Act case filed by three former employees, Cephalon had a motion to dismiss denied in District Court. Part of the plaintiffs’ case asserts that Cephalon is responsible for reverse false claims (where the claim results from payments not paid to the government rather than from a false payment being received from the government) because the alleged activity occurred while Cephalon was under a CIA. The plaintiffs say because Cephalon did not report off-label marketing of two of its products, it falsely certified reports submitted to the OIG while under a CIA.  These false reports were subject to penalty per the CIA, therefore Cephalon did not pay the government the money it was due. Cephalon said the reverse false claim should not apply because the stipulated penalties in the CIA are at the discretion of the OIG. The judge disagreed with Cephalon’s argument, and compared the CIA penalties to a breach of contract.

This week’s news was certainly full of more Sunshine than moonlight. And of course, by Sunshine, we mean physician spend disclosure. As evident in this week’s news, disclosure of physician spend is truly a global concern. We believe there are a couple of key training considerations for companies in the midst of adapting to not only the U.S.’s transparency requirements, but those in force in other countries. One such consideration is ensuring you’re capturing the entire audience. It can be easy to focus on the immediate audience.  Need to train on Loi Bertrand? Obviously colleagues based in France are the target; it is a French law after all.  However, what of colleagues with regional responsibilities, and those in a global role who may interact with physicians in France. Another consideration is knowledge sharing. In the U.S. we’ve been at this for a while. States have had disclosure requirements for more than two decades. Sharing with colleagues overseas the lessons learned from training timing, methodology, deployment, and so on can be helpful in successfully getting a transparency program off the ground elsewhere. And that sharing doesn’t have to be one-way. Colleagues overseas should share their successes with U.S.-based colleagues to see what can be improved upon in programs here.

Compliance News in Review, July 20, 2015

The House of Representatives passes the 21st Century Cures Act, two companies settle AMP charges, oral arguments begin in Amarin v. FDA, and CMS updates its Open Payments FAQs.

Diamonds are not only a girl’s best friend…a very special mouse is fond of them as well. The Happiest Place on Earth (or, at least the one in California), is celebrating its diamond anniversary. Happy 60th Disneyland! The place has certainly changed in its 60 years, but fan favorites such as Mr. Toad’s Wild Ride and the Jungle Cruise have stood the test of time. In true Disney fashion, the party isn’t just a one day affair; it actually started back in May and will likely continue through the fall, if not into 2017. Before we cut the cake with the big ears, we have a bit of “magic” of own to administer. Grab a churro and settle in for this edition of the Compliance News in Review.

The House is celebrating the overwhelming passage of the 21st Century Cures Act. The bill is designed to fund research and change the FDA’s drug and device approval process. It includes a change to the rule its provisions are changes to the Sunshine Act which would exclude the reporting of the value of journal reprints and payments for CME.

AstraZeneca and Cephalon may be feeling a bit Grumpy. The two companies reached separate agreements with the government over charges related to underpaid Medicaid rebates. According to a whistleblower, the companies improperly reduced the Average Manufacturers Price (AMP) of their products by subtracting fees paid to wholesalers. The companies paid $46.5 million and $7.5 million respectively to settle the matter.

Oral arguments began in Amarin’s suit against the FDA. The company cited the Caronia decision and the Sorrell v. IMS decision in its argument. Much of the discussion centered on the type of disclaimers need to accompany off-label promotion and not whether Amarin even has a right to do so. The FDA’s lawyer argued the interpretation of the Caronia decision should be very narrow but the judge disagreed. A judicial order is expected in a few weeks.

The whistleblower in a case against Endo may be throwing a Mad Tea Party now that she’s been awarded $33.6 million for her efforts. The case, which was settled with the government in February of last year, involved the off-label promotion of the company’s pain patch. Despite a recommendation from government lawyers that the whistleblower receive 19% of the settlement, the federal judge awarded her 24%, citing her “extraordinary effort” in the case. The whistleblower initially filed suit in 2005, and spent five of the nine years that followed working under the direction of the FBI.

CMS has sprinkled some Pixie Dust over the Open Payments FAQs, and sure enough new FAQs have taken flight. Several of the new FAQs have to do with physicians and teaching hospitals being able to access, review and dispute the data now that the review and dispute period has closed.

If the FAQ updates weren’t enough, CMS was back for a second ride with updated information about the reporting of CME payments on the Law and Policy page of the Open Payments website. Beginning in 2016, manufacturers will have to report indirect payments to CME providers if the manufacturers learn the identity of the physician attendees or speakers within the reporting year, or the first two quarters following the reporting year.

The updates to the Open Payments website remind us that the program is evolving. Your company’s training needs to evolve and grow as well. Affected personnel need to be updated on changes, and reminded of the need to communicate with their physicians. Now is the time to map out your plan for refresher training and refocus your aggregate spend and sales personnel.

That’s a wrap on the compliance news fit to blog for now. Have a great week everyone.



Compliance News in Review, July 10, 2015

The government targets Novartis for False Claims violations, pharmaceutical companies map out a plan to keep medication flowing into Greece throughout the crisis, and the industry as a whole ponders the impact of the CMS release of 2014 transparency data.

The days are long and lazy – it’s time for summer vacation! From the beach, to the mountains to foreign destinations, the News in Review staff is finalizing plans for summer R&R. Rest assured though, we are still hard at work keeping up with all the compliance news fit to blog, starting with this sun splashed edition of the Compliance News in Review.

The Justice Department and 11 states are putting a dent in the Novartis vacation account with a $3.4 billion charge for damages and fines in a False Claims Act case involving kickbacks to pharmacies. According to prosecutors, the company offered rebate and discount programs to pharmacies in exchange for increased prescriptions of two drugs. Novartis disputes the allegations and says it will continue to defend itself. A trial has been set for November.

Pharma companies are mapping out a plan to keep medication rolling into Greece. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the complexity and fragmented nature of the Greek medicine supply chain makes the flow of medication vulnerable. Pfizer, Roche and Novartis said they have plans to ease any shortages during the crisis, and AstraZeneca and GSK have both said they are drawing up contingency plans to keep medicines in supply.

CMS and agg spend folks are probably ready for a break in their routine now that the 2014 Open Payments data has been published. The data shows that companies paid physicians almost $6.5 billion for the year, with over 11 million transactions reported. Research payments topped the list with over $3 billion paid, there were $2.5 billion in general payments and $700K was reported on the ownership reports. CMS was able to validate close to 99% of records submitted to the system, which is a vast improvement over the 2013 data. As was the case in 2014, the majority of the reported payments were small. Sixty-six percent were for payments of less than $20. Research and royalty payments represented the largest dollar amounts.

Once the Open Payments data was released, the numbers quickly found their way into the media. The focus on payments to physician and the influence those payments have on prescribing decisions and healthcare at large is at an all-time high. That level of scrutiny highlights the need for training on the Sunshine Act and Open Payments – especially for those interacting with HCPs. While much of the work related to the reporting requirements is a “back office” function, those interacting with HCPs are often the first to hear concerns from the field and they need to be prepared.

In addition, the public release of the data opens companies to examination of their business practices from whistleblowers and enforcement agencies. Critical evaluation of training is important. Are all the appropriate audiences being covered? Is the training up to date? Is a refresher required? Regular audits of training curriculums and plans are key to reducing the risk of questionable payments, and could spare the company expensive costs down the road.

Have a great weekend!

Compliance News in Review, July 2, 2015

A former medical device CEO is sentence to two years in prison, the House of Representatives moves on the exemption of payments for CME, textbooks and medical literature under Sunshine, a Connecticut APRN finds herself in hot water over kickbacks, and the first full year of physician payments data is officially available for review.

Unfurl the flag and fire up the grill! It’s time to celebrate the good ole U.S.A. Independence Day is almost here! Whether your celebration of the shot heard ‘round the world and 239 years of the great experiment take you to the shining sea, across the fruited plain, or just to your backyard, we hope it’s a safe and joyous weekend. Until the party begins, we’ll dole out a little history less of our own, with this edition of the Compliance News in Review.

Former OtisMed CEO will have his liberty temporarily revoked. The executive was sentenced to two years in prison for intentionally distributing an unapproved medical device in violation of the FDCA. He was also order to pay a $75,000 fine.

The “people’s house” has been busy recently. The House Energy and Commerce Committee announced that over 200 representatives have signed on to the 21st Century Cures Act. The exemption of payments for CME, textbooks and medical literature from the Sunshine Act is included in the bill. The House also approved a bill to repeal the Affordable Care Act’s tax on medical device manufacturers. The bill now moves to the Senate for a vote.

A Connecticut APRN has admitted to accepting $83,000 in kickbacks from the drug maker Insys Therapeutic. The nurse was a top prescriber of the company’s cancer pain drug. Most of the kickbacks were in the form of payments for serving as a speaker and according to prosecutors, more often than not, the nurse and the sales rep were the only people in attendance at the speaker events. On some occasions, the attendees were friends or colleagues of the nurse who were allowed to prescribe drugs. She will be sentenced in September.

We’re waiting for the fireworks to start now that the first full year of physician payments data has been released by CMS. The payments for 2014 totaled nearly $6.5 billion, and represented 11.4 million transactions to over 600,000 physicians and teaching hospitals. Data from the 2013 program year that could not be posted during 2014 is also included in this year’s release. According to a CMS press release, “registered physicians and teaching hospitals reviewed nearly 30% of the total value of the data and the agency plans on continuing its efforts to work with HCPs to increase that review rate.”

While it’s the multi-million dollar corporate settlements that make the headlines, this week’s news shows that in the world of compliance, individuals suffer significant consequences as well. From the Board to the C-suite, across the corporation and even to the contractors, training needs to emphasize that potential violations are not just a “company problem.”

The release of the 2014 Open Payments data highlights the amount of money being spent by industry on physicians, and exposes physicians to potential criticism and scrutiny. HCPs need to be aware of the rules and regulations companies face because as far as the government is concerned, they represent the company just as the employees do. Providing training that respects these contractors as men and women of science, while fully covering product promotion regulations and law, not only protects the company, it enhances the relationship with these valued partners in healthcare as well.

Have a great Independence Day everyone!

Compliance News in Review, June 29, 2015

The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.

PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.

The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.

The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.

FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.

Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.

Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.

All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.

That’s the news for this edition. Stay cool and have a great week everyone!

Looking Ahead: CBI’s 9th Annual Forum on Transparency and Aggregate Spend

The release of the first full year of data under the Open Payments Program is just around the corner, which naturally means transparency and aggregate spend are top of mind these days. Will the data be released without any issues? How will the media react?

With aggregate spend on the mind, the NXLevel Solutions PharmaCertify™ team is looking with interest at the conference agenda for CBI’s 9th Annual Forum on Transparency and Aggregate Spend. We’ve selected a few sessions of particular interest.

Here’s what caught our attention:

Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Analytics – Obviously, companies are collecting mass amounts of data to comply with transparency requirements here and abroad. Analyzing the data to identify potential compliance risks is a great way to help fine tune training as well. For example, such an analysis may reveal areas where more in depth training is needed, or it may identify a new audience that needs training on a particular topic. We’ll be interested to hear how training fits into the agenda for this session.

State Disclosure Laws – Preemption, Enforcement and Continued Reporting – Just when we thought the Sunshine Act would clarify state reporting requirements, more changes have arrived in our in box; the latest requiring the reporting of payments to nurse practitioners in a couple of states. This session looks to be a great opportunity to learn the latest in state requirements, and to hear how those states plan to utilize the federal data.

HCP Perspectives on Transparency – Impact and Opportunities Moving Forward – Applicable Manufacturers are not the only ones affected by the Open Payments Program and other transparency initiatives. With little to no voice in the matter, healthcare professionals bear the brunt of having information about them exposed to the public. Understanding HCPs’ transparency concerns is a critical step in training those who interact with HCPs.

The Global Transparency track, which includes a session on Building a Global Transparency Solutions Center, is dedicated to the transparency requirements of the European Federation of Pharmaceutical Industries and Associations (EFPIA). With reporting beginning next year, EFPIA requirements are no doubt a hot topic, but EFPIA’s requirements aren’t the only ones of concern outside the U.S. Understanding the requirements of each code and law and finding commonalities is important when building the systems to manage the data, and building effective training around these requirements. Can training be repurposed from one jurisdiction to another? What “lessons learned” from one location can be applied as more associations and countries implement transparency requirements?

In between conference sessions, we invite you to stop by the PharmaCertify™ booth to discuss your global transparency training challenges in more detail. We’ll be providing demos of our TOV Disclosure Portal™, an exciting new product that gives your company the opportunity to roll out transparency payment data to your partner HCPs for their review and approval before it is submitted to CMS. When disputes are resolved early, HCPs are more confident in the accuracy of the data, and the company/HCP relationship is enhanced. And, if you have to miss this year’s conference, contact Sean Murphy at

Stay compliant and we’ll see you in August!


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