UK Bribery Act

News in Review, August 11, 2015

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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.

Week in Review, April 21, 2015

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CMS tries to clarify the Open Payments review and dispute process, GSK considers changing its compensation program, and a Florida pharmaceutical manufacturing company is charges with selling unapproved products.

April showers bring May flowers, or so the saying goes. Well if you live in the southeast or northeast corner of the country, it will apparently be an extra flowery May. Rain, rain and more rain has fallen over a good chunk of the country. While that rain is certainly a good thing, the accompanying flooding isn’t. Luckily, sunny weather is on the way according to the pundits and folks can dry out. As we wait for those flowers dry out enough to bloom, we’ll rain some compliance information down on you in this week’s Compliance News in Review.

The Sunshine is back out over the medical community, but the mood is a little gloomy. CMS held a conference call for reportable recipients under the Sunshine Act to discuss the Open Payments review and dispute process. CMS reiterated its stance, that it will not intervene in disputes, but will be monitoring the process. The agency is particularly interested in the number of disputes that are initiated and how many remain unresolved. Reportable recipients expressed frustration that there was not enough context or consistency among manufacturers in how payments are classified under the “nature of payment.” This makes it difficult for reportable recipients to determine whether a payment is correct. CMS said input from all parties would be required before any changes are made.

The winds of change are blowing for GSK and its sales rep compensation structure…again. A task force has been put in place to examine how to simplify the company’s “Patient First” program. The current program establishes bonuses on factors such as product knowledge and understanding the needs of patients and doctors, rather than prescription numbers. A GSK spokesperson says the company remains committed to their commercial model, and while the company has looked for ways to simplify the program in other countries, the fundamentals of the program remain the same.

There’s been no singing in the rain for Florida based Stratus Pharmaceuticals. The distributor had $1.5 million in unapproved drugs seized by U.S. Marshals. The confiscation of the drugs came at the request of the FDA and U.S. Attorney for the Southern Florida District. According to the FDA, Stratus was marketing and distributing a number of unapproved drugs, including an antibiotic skin cleanser, a topical cream to treat psoriasis and eczema, and a topical ointment for treating wounds. The drugs were manufactured by Sonar Products of New Jersey.

With that, we bring this rain-soaked edition of the News in Review to a close. Remember, if the winds of change are long overdue for your compliance training curriculum, the PharmaCertify™ suite of customizable compliance solutions offers the up-to-date training where your learners need it most – in the field and at their fingertips.

Have a safe (and dry) week everyone!

News Week in Review, April 13, 2015

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Spain and Malaysia amend their anticorruption laws, researchers from the NIH say the government rules on paperwork and travel are too complex, and India considers dedicated oversight for medical device.

Golf voices and claps only, please. It’s time to celebrate the greenest spectacle in sports – the Masters. The lush fairways, that somewhat disturbing green jacket and we can’t forget the green ($10M total) won by the top players. This year’s event saw the return of Tiger Woods, Jack Nicklaus making a career first hole-in-one at the Par 3 tournament, and the record breaking victory by Jason Spieth. Now that the drama is over and the young man from Texas held off the field, it’s time to tee off on this week’s Compliance News in Review.

A pair of countries legislating compliance programs are the first on the tee this week. At the end of March, the Spanish Congress approved amendments to its Criminal Code, which requires companies to adopt a compliance program. The change is effective as of July 1, 2015. According to the law, compliance programs must be supervised by a group or individual that can exercise a high level of control. The law provides a company protection from criminal prosecution when the company’s compliance program when the individuals responsible for the compliance program did not neglect their duties. It also details six element’s that must be included in order for the company to be protected from prosecution.

Malaysia’s Attorney General wants to amend country’s current anticorruption law to address corporate liability. A deputy with the Malaysian Anticorruption Commission (MACC) said the U.K. Bribery Act and FCPA were being used as guidelines for the Malaysian law.

Medical researchers from the National Institutes of Health (NIH) would like a mulligan, of sorts, on the paperwork required for travel to attend medical conferences. Researchers say the government’s paperwork and travel approval process is time consuming and is hurting science and it can take up to six months to learn whether they’ve been approved to travel to conferences and meetings. The strict rules were put in place following a scandal involving travel at the General Services Administration. One researcher said he had to turn down a speaking request at a popular conference because the agency has to limit how many individuals it sends to any one event, and he is often passed over as a speaker because conference organizers don’t believe he’ll be able to attend. The NIH spent over $14 million in oversight of travel and expenses in 2014, which was nearly a quarter of its total travel budget for the year.

India is bringing medical device oversight on par with how drugs are regulated. A government task force is recommending a separate regulator be put in place to oversee safety and price controls of diagnostic equipment, implants and hospital equipment. Currently, devices are regulated under the same act as drugs, but both industry and public health advocates have argued that devices are different and should be regulated under different rules.

With that, we put a bow on another year of the “tradition unlike any other,” and another edition of the Compliance News in Reviews. Have a great week everyone, and as you hit the greens this year, remember the words of the late, great Paul Harvey, “golf is a game in which you yell ‘fore,’ shoot six, and write down five.”

Week in Review, April 6, 2015

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West Virginia repeals its disclosure law, Connecticut modifies its requirements for insurance coverage related to off-label use, two whistleblowers file a suit against Teva, and tighter transparency rules are debated in New Zealand.

Spring has sprung! Woo hoo! Since a number of us “enjoyed” up to 5 inches of snow on the first day official of spring, a break from the drudgery of the bitter temperatures is well-deserved, nay, warranted. The compliance news doesn’t take a break though, so for now, we’ll put our visions of sand castles and sea gulls to the side and focus on all the news fit for blogging, with this week’s Compliance News in Review.

It seems there’s no vacation when it comes to state transparency laws. The governor of West Virginia has approved a bill that will repeal the State’s requirement for pharma companies to report drug advertising and promotion expenses. Expenditures for 2014 are due in April, but the repeal will end the reporting requirement from January 1, 2015 forward. The GOHELP organization has not publicly published advertising expenditures reports since 2010.

Consumers in Connecticut could be getting a break when obtaining medications for off-label uses. A modification to the state’s current law will increase insurance coverage of drugs prescribed for off-label uses. The current law requires off-label coverage if the drug appears in one of three specific medical compendia. Unfortunately, two of the references are no longer published. The revision to the law would require coverage if significant information in peer-reviewed publications support the off-label use.

BioChemics was ordered to pay over $17 million to settle investor fraud charges brought by the SEC. The SEC says the company lied to investors about its research, FDA communications, and status of clinical trials, and provided false valuations for the company. The company collected over $9M from 70 investors. The judgement supplements another judgement against the company’s founder and two promoters from earlier in the month.

Party crashers? A new survey shows securities fraud class action suits against life sciences companies are on the rise. In 2013, there were 19 suits against life science companies. In 2014 that number rose to 39, and represented 23% of all securities fraud cases for the year. Most of the defendants were smaller companies.

Green is the color of spring, and apparently the color of honorarium envelopes at Teva, according to two former sales reps. A whistleblower suit filed against the company claims that Teva engaged in sham consulting arrangements in order to boost prescriptions of Copaxone and Azilect. The two claim that doctors were only allowed to remain speakers for the company if they increased the number of prescriptions written for covered drugs, and that the content of the programs had very little educational value.

The “sunshine” is shining bright in New Zealand, even though they are celebrating the fall season there. In a recent New Zealand Medical Journal article, transparency advocates made an appeal for a U.S. style Sunshine Act. The authors argue that while disclosure requirements are being tightened in other countries, the situation remains “murky” in New Zealand, where doctors receive remuneration for a variety of services, and sponsorship for accommodations and travel to conferences. One of the authors has spoken out about the topic in the past, and has been critical of Medicines New Zealand for its lack of transparency regarding the disclosure of physician payments. While not outright dismissing the idea, Medicines New Zealand has stated that adding disclosure requirements would be complex and require a significant amount of resources.

With that, we close out this spring season edition of the Compliance News in Review. Speaking of sunshine, as transparency requirements grow around the world, the PharmaCertify suite of training solutions offers your learners the content they need to navigate the cloudy world of pharmaceutical compliance reporting regulations.

Have a great week everyone!

The 2015 Pharmaceutical Compliance Congress: A Review and Recap

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The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array of content was covered, the focus often turned to two key topics – Speaker Programs and the FCPA.

Day 1

The conference kicked off with a keynote speech from Michael Shaw, Vice President and Chief Compliance Officer for GlaxoSmithKline. Shaw’s presentation was focused on the idea that instilling a culture of compliance is not enough in today’s regulatory environment. He emphasized the importance of ‘explaining the why’ behind the values, and the need to hold individuals accountable for compliance. As an example, at GSK, while Compliance is responsible for facilitating the process, Brand Directors are held accountable for managing the risk. As Shaw says, “compliance programs are important, but they’re not enough. The elements of the programs need to have traction.”

Otsuka ‘s Regina Gore Cavaliere and Brian Miller showcased their use of humor as a core tool for compliance training. Cavaliere and Miller have integrated a variety of creative elements, including a mock mini-series called The Pharm, comic books, and live talk shows, into their curriculum to keep the training fresh and appealing. Much of what was presented was indeed witty and engaging, and it showed that comedy can clearly be an effective tool when developed professionally and integrated carefully into a blended campaign.

In the Chief Compliance Officer Panel titled, Working with the Business – Ensure Compliance Adds Value to Operational Success, Jeffrey Rosenbaum from Vertex, Sujata Dayal from J&J, and Sumita Ray from Pharmacyclics, offered their perspectives on the keys to an effective program. With limited resources and time, Rosenbaum starts with his company’s business objectives while managing the issues with the highest risks. Ray agreed, saying she evaluates what risks she has to address on a daily basis, making training her first priority. As part of a large global company, Dayal begins with a formal risk assessment and conducts testing on a regular basis to ensure that mitigation is working. Rosenbaum also emphasized the importance of recruiting allies in the company when resources are stretched, as with Sunshine Act reporting, while Ray echoed Michael Shaw’s points about the importance of holding businesses accountable for their actions and results.

The presentations shifted to a governmental and regulator’s perspective with Doug Brown from CMS updating the audience on the state of Open Payments, a panel of US Attorneys addressing trends and top priorities in healthcare enforcement, and Andrew Ceresney, Director of Enforcement at the SEC covering disclosure issues relevant to the pharmaceutical industry.

What stood out during the enforcement panel was the increased amount of cases the regulators are seeing involving small to mid-size companies. Greg Shapiro, from the District of Massachusetts added that the audience should expect to see more criminal liability with those cases. Jacob Elberg, from the District of New Jersey encouraged those who identify a problem to self-report since “it sends the right message to employees and regulators.” More than one panel member delved into the risks of Speaker Programs, with Shapiro calling them “areas prone for abuse” and William Killian from Tennessee reminding the audience that Speaker Programs must not be tied to any promotion of business.

Ceresney covered the FCPA and the risks particular to the pharmaceutical industry. According to Ceresney, the SEC is focusing on three enforcement areas: pay to prescribe, pay to get on formularies, and charitable contributions. He emphasized the need for risk assessments and training, and the need to take measures when issues are identified.

After lunch, the sessions were divided into smaller groups, and I opted to stay with the FCPA theme in the session titled, Strengthen your FCPA Compliance through Smarter Training. David Nicoli, former VP, Corporate Affairs, AstraZeneca, and a panel of vendors walked through the steps they consider to be crucial when training on the FCPA. Collaboration is key, Nicoli claimed, and during his tenure at AZ he partnered on training initiatives with key allies, such as the Heads of Human Resources and Social Responsibility, who truly understand the work environment. The panel stressed the need for short, quick hits in FCPA training, and the fact that bad decisions make for good stories that stick in learners’ minds.

After the FCPA session, I jumped into the track dedicated to Product Promotional Compliance. Paul Silver from Huron presented statistics from a recent industry survey on company interactions with HCPs. For example, 86% of companies reimburse for HCP travel time and 1/3 of the companies surveyed have a limit on hotel expenses. Overall, the statistics presented a strong baseline for how the industry handles HCP travel time and I highly recommend the data for those interested in knowing what their peers are doing.

The session on overseeing the relationships between Sales, MSLs, and Managed Care Reps, was highlighted by one powerful statement from Kevin Stark, Director of GHH Compliance, at Merck, which could be considered a compelling theme for the entire conference, “build a culture where it’s okay for people to admit when they made a mistake.”

Day 2

The second day opened with Tom Abrams of the FDA and his annual update on enforcement trends at the Office of Prescription Drug Marketing. In the area of policy and guidance development, OPDP has released six draft documents since January 2014, and three draft guidance documents on social media.

Abrams’ agency continues to allocate resources and priorities based on potential threats to public health. The most common violations over the past year were related to omission and minimization of risks, and unsubstantiated superiority claims.

Day 2’s enforcement panel, titled, A View from the Outside —Mitigate Risk and Prepare for the Future featured a panel of defense attorneys well-versed in the areas of risk for small and large pharmaceutical companies. Scott Lieberman of Loeb and Loeb stressed the need for sales representatives to know exactly how to handle off-label questions when dealing with HCPs. Matthew O’Connor, of Covington & Burling warned smaller companies to allocate enough resources to monitoring, an area often neglected. When asked about the relationship between Compliance and Legal, Allison Shuren from Arnold & Porter said Compliance should be the “boots on the ground, moving issues up the food chain,” and John Richter, from King & Spalding, noted that Compliance should be ‘setting the policy and evaluating the balance between costs and risks.’

I was particularly interested in the Life After a CIA — Impact on Internal Team Structures and Resource Allocation panel, so I attended the breakout session: Compliance Program Structure and Effectiveness.

Sujata Dayal, from J&J, stressed the need to continue the conversation between the businesses and Compliance but that dialogue needs to change as the role of the business shifts from one in which the businesses mandates company priorities to one in which they influence actions and decisions. Gregory Beeman, from Eli Lilly, said the first step was to see what can be streamlined and continued post-CIA. In other words, what was under OIG oversight that could be eliminated now that the CIA has expired?

In Successful Promotional Programs — How to Use Data Analysis & Market Research to Drive Compliant, Effective Results, Mark Dizon from Actelion, and David Gilman from Huron led a spirited discussion on the use of data and analytics to assess risks and results of Speaker Programs. The idea of whether Speaker Programs should be evaluated against Return on Investment was of particular interest as audience members and the panel members debated the merits and risks associated with acknowledgement of the ROI.

The final session I attended was focused on the challenges faced by small to mid-size businesses as they struggle to allocate compliance resources. The panel, consisting of Timothy Ayers of Porzio, Bromberg & Newman, Katrina Church of Merz North America, Jeff Rosenbaum from Vertex, Sarah Whipple from Aegerion, and Greg Moss from Kadmon, offered a diverse set of best practices based on their experiences with limited resources and time. The perspective offered by those who are literally ‘departments of one,’ and those, like Church from Merz, whose departments are growing rapidly, had enough content, suggestions, and tips to fill a conference unto itself. As one example, the panel and audience debated the benefits and challenges of live training versus eLearning. While live training offers the opportunity to work face-to-face with each trainee, which is easily achieved in very small companies, Church was quick to point out that as Merz grew, a shift to more eLearning, with its streamlined tracking, became a necessity. And, like their colleagues from larger companies, these participants emphasized the need to include the Board of Directors and the C-Suite in the importance of compliance training; and in getting buy-in at all levels of the company.

To sum up, the details brought forth over two days by many well thought out presentations and panel sessions in this year’s Pharmaceutical Compliance Congress offered veteran attendees and new comers alike a wealth of practical and impactful information, making attendance not only a good idea, but crucially important to staying abreast of new developments and best practices in life sciences compliance.

News Week in Review, February 18, 2015

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Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on Healthcare holds a lively panel session on the Sunshine Act.

Laissez les bons temps rouler, y’all! The end of the Carnival season is here and yesterday was the big send off…Fat Tuesday! Or as you may know it, Mardi Gras. Yes, a time of frolic, frivolity, and according to Turbo Tax, a number of incidents that can affect the filing of your taxes for the next year. Whether you partied until the wee hours in NOLA, or just enjoyed the simple fun of a pancake dinner at home, we hope it was a great celebration. Now it’s time for our regular look back at some of the “celebrated” compliance news of the week, with this edition of the Compliance News in Review.

We start today’s parade with settlement news for several industry companies. Medtronic agreed to pay $2.9 million to settle allegations it violated the False Claims Act. The government alleges the company caused claims to be submitted to Medicare and Medicaid for an investigational procedure. Next, AstraZeneca paid $7.9 million to settle charges it violated the False Claims Act. The company is alleged to have paid kickbacks to PBM Medco in exchange for Nexium’s “solely and exclusively” being maintained on Medco’s formulary. The government claims the kickbacks were provided as prices concessions on other AstraZeneca drugs. Finally, a physician has pled guilty to accepting kickbacks from two pharmaceutical companies in exchange for prescribing the drug, Clozapine. The physician received nearly $600,000 in kickbacks and benefits from IVAX and later, Teva. He also agreed to pay over $3 million to settle a parallel civil case.

The Centers for Medicare & Medicaid Services has been busy tossing beads and doubloons to the industry in the form of advice and consultation. Another Open Payments Q&A session was held just this past week, and in advance of the Q&A session, CMS released several new resources covering system registration and data submissions. The agency has also posted the audio from the January Q&A session.

Speaking of the Q&A session, the February session covered a couple of important topics for industry stakeholders. First, it was announced that a fix would occur over the Valentine’s Day/Presidents Day weekend that should resolve most of the problems that companies are having with submission of the 2013 data. On the downside, attendees were notified that the release of the Validated Physician List has been delayed. CMS is hoping to have the list ready by February 20. Those on the call were reminded that this list is only comprised of physicians for whom a 2013 record was submitted. CMS is scheduling a full day to take stakeholder questions. As soon as a date is nailed down, it will be announced on the Open Payments website and via a listserv email.

It wasn’t exactly cause for great celebration, but a recent briefing held by the National Coalition on Healthcare led to the call for expanded requirements under the Sunshine Act. The panel was comprised of individuals from the government, physician groups and the Pew Charitable Trust. A representative from Senator Grassley’s office explained that ultimate goal of the Sunshine Act was to spur an open discussion between patients and their doctors. The founder of PharmedOut, an organization that advocates against pharmaceutical marketing influence in medicine, took the harshest stance, saying the law wasn’t strict enough. She accused companies of seeking out the family and friends of physicians as an avenue for delivering marketing messages, and expressed grave concern about the industry engaging in disease state awareness. Drug samples were a hot topic. A representative from the AMA says there is a gap in transparency where the provision of samples is concerned and he believes providing samples is “misdirected and unsafe.” The founder of PharmedOut agreed, stating that patients should refuse samples and ask for older drugs that have stood the test of time.

That’s about it for the edition of our weekly look back on all the news fit to blog. As we get closer to spring (albeit, slowly for those of us in the Northeast), and the annual POAs are in the rear view mirror, this is as good as time as any to clean up your commercial compliance training. With transparency extending beyond the U.S., shouldn’t your training do the same? The newest addition to our PharmaCertify™ suite of off-the-shelf eLearning modules, Global Transparency: Reporting HCP and HCO Transfers of Value covers the key provisions of the EFPIA Disclosure Code, French Sunshine Act (Loi Bertrand) and the Medicines Australia Code of Conduct. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more and see a content outline.

Have a great week everyone!

News Week in Review, January 26, 2015

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Senator Warren looks to use pharmaceutical company penalties to support research at the FDA and NIH, a new report reveals that a significant amount of businesses in China pay bribes, a physician lobbies for a Sunshine Act in Scotland, and a bill is introduced in the House to exclude CME and medical texts from Sunshine reporting.

Comedy, drama and just a dash of controversy thrown in for good measure. No, we’re not referring to this year’s Oscar nominations – although one does have to wonder how The Lego Movie was snubbed for Best Animated Picture – we’re talking about the NFL’s annual supreme slugfest, the Super Bowl. This Sunday, millions will park themselves in front of their television sets to see the Patriots and Seahawks fight it out for the Lombardi Trophy (and of course, the cursory trip to Walt Disney World). If you’re ready for a brief respite from the politics of “Deflate-gate,” we offer all the compliance news fit to blog, with this week’s News in Review.

Starting on offense in our first story is Senator Elizabeth Warren. During a conference hosted by a health advocacy group, the Senator said she intends to introduce legislation that will create a fund to support research at the FDA and NIH. The fund, which Warren referred to as a “swear jar” for the industry, would be financed through fines imposed on large pharmaceutical companies that break the law. Fines will only be imposed on companies with at least one blockbuster drug, and would equal 1% of a company’s total profits for each blockbuster drug it sells.

PhRMA quickly lined up on the other side of the ball to oppose the issue. The organization pointed out that the industry spends billions of dollars on research each year and is responsible for 20% of all funding of domestic research. The statement went on to say the work of the NIH is important, but to “siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society.” Those consequences would ultimately include fewer medicines and loss of jobs.

If you think Deflate-gate is controversial, it doesn’t compare to a recent report that found 35% of businesses in China pay bribes in order to do business in the country. One CEO participating in the research called bribery the “unspoken rule.” The problem is more common in foreign companies than those based on the mainland, and the real estate and construction sectors have the highest instances of bribery. The vast majority of research participants describe bribery in China as a “plague,” and just over 60% of the participants would like to see action taken to stave off the problem. Unfortunately, a third of participants are not optimistic about that happening.

It’s third down and goal for a transparency initiative in Scotland. A physician will have his petition for a Sunshine Act in Scotland heard by the Scottish Parliament for the third time. The physician is petitioning the government to create a law that establishes a searchable database of payments from pharmaceutical companies to National Health Service healthcare workers.

We’re back in the transparency replay booth here in the U.S. as well. A bipartisan bill was introduced in the House of Representatives to exclude the value of CME and medical texts from reporting, under the Sunshine Act. This is the second go around for the bill in the House.

Well, that’s it for this Super edition of the Compliance News in Review. Whether you’re rooting for the Seahawks or Patriots, or just a great halftime show by Katy Perry, enjoy the game and we’ll see you right back here next week. Have a great week everyone!

2014 Year in Review

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2015 is upon us! It seems like only yesterday we were posting our 2014 Compliance Year in Review. Time sure does fly! We here at the Compliance News in Review wish you and yours the best for a happy and healthy 2015. But don’t toss out that warm glass of sparkling cider or noisemaker yet. It’s time to take a look back at a year’s worth of news, with the Compliance News Year in Review – 2014 Edition.

Our countdown begins with what had to be the big story of 2014 – the never ending saga of Open Payments and the Sunshine Act. The year began with a two-phase registration and data submission process for Applicable Manufacturers and GPOs. Phase 1 opened in February and Phase 2 was supposed to start in May. As it turned out, Phase 2 was delayed until June and was deployed in two phases itself, and not without some technical difficulty. So much so that PhRMA petitioned CMS to extend Phase 2 by as much as 30 days.

The registration of physicians and the opening of the review and dispute period represented the next big milestones. That’s when the fireworks really started. Physicians had problems registering, and when they could finally view the data, there were significant problems – confusing “error” messages, missing payments, payments attributed incorrectly. CMS took the system down to correct the problems, and extended the review and dispute period to accommodate for the time the system was down. When Open Payments opened back up for physicians, almost one-third of manufacturer records were “missing.” Eventually, CMS said the records were withheld due to data matching problems. A number of issues were identified that caused the data to disappear. The primary offenders appeared to be state license numbers and NPI numbers submitted by manufacturers and GPOs that did not exactly match what CMS had in its database for those identifiers. Despite all the delays and problems, CMS said the September 30th date for making payment records public would stand, minus the withheld records. Those records would be published by June 30 of the next year.

September 30th came, data was published, and all was right with the world, right? Onward to 2015! Not so fast there dear readers. As we all spent time regretting those unfortunate photos taken at the office Christmas party, CMS elves were busy at work. The agency released 68,000 records that were previously withheld, notified users that Open Payments would be unavailable for most of January to allow time for system maintenance, and announced it will be hosting an Open Payments Q&A in early 2015.

Yes, it was a full year of Open Payments fun, but the news surrounding the data was not all CMS had up its transparency sleeve. The agency notified stakeholders that changes were on the way for Sunshine’s Final Rule. The one change that sparked the most debate was the removal of the exemption for payments to physicians speaking at accredited CME events. Medical societies, physician groups and CME providers were staunchly opposed to the change, but it was still made official in October. The change will take effect in 2016 but it may not be the end of the road for the exemption. A bipartisan bill was proposed to exempt indirect CME payments, as well as the value of medical textbooks and reprints.

Other news of note on the transparency front for 2014 included the passage of a law in Connecticut that requires the reporting of industry payments to nurse practitioners; Minnesota making good on the Board of Pharmacy’s notification that payments to nurse practitioners and others would be required in 2015 reports; and the changes in transparency requirements to the Medicines Australia Code of Conduct.

The cork popped on GSK’s bribery woes in 2014. The company was one of several pharmaceutical companies under investigation by the Chinese government for allegations of bribery. The company announced it was investigating potential bribery in Iraq, Jordan, Lebanon, Poland, and Syria. GSK enhanced its compliance efforts in China and fired several employees over failure to adhere to expenses rules. In the fall, it was able to close the book on the Chinese investigation with a fine of close to $500 million dollars. The head of China operations and four other executives were sentenced in the matter, but all had their jail sentences suspended and avoided actual jail time. The head of China operations, a British national, was deported. The company could still face legal action from the U.S. Department of Justice and the U.K.’s Serious Fraud Office for violating bribery laws.

The FDA resolved it would make the July 2014 deadline for social media guidance, and it actually did! Three draft guidance documents related to social media were published. One document is related to the submission of advertising content, and the other two dealt with actual postings on social media platforms. The guidance on correcting misinformation on social media platforms applies to correcting independent user-generated content, and not content generated by a company, its employees or agents.

The more anticipated document, and the one that drew the most criticism, deals with the posting of information on character-limited platforms, such as Twitter. Some companies feel the FDA has basically restricted them from using character-limited platforms to promote their products due to strict requirements around presenting risk and benefit. The Washington Legal Foundation and the Medical Information Working Group said the guidance infringes upon manufacturers First Amendment rights.

And there you have it, our choices for top stories of 2014. What will be the “big news” of 2015? If we were betting people, we’d put money on Open Payments and Sunshine being the stories that generate the most headlines. With a full year’s worth of spend data hitting the system for the first time, expect more hiccups. Also, a full year’s worth of data is likely to reveal even more issues and have the pundits buzzing. Transparency overseas will likely make news in 2015, as EFPIA member associations and Medicines Australia members begin collecting data for disclosure in 2016.

There was a noticeable lack of big dollar enforcement cases in healthcare fraud and FCPA cases last year. While the DOJ could boast upwards to $2 billion in healthcare fraud recoveries for the 2014 fiscal year, there were no billion or multibillion dollar settlements with life sciences companies. The crystal ball is a little cloudy on that front. Was 2014 the calm before the next storm, or has the season of the multimillion to billion dollar settlements with pharma and med device companies come to an end?

FCPA enforcement actions were in a bit of a lull through at least the first half of 2014 compared to years past. The DOJ ended the year on a big note though, with its Alstom settlement. As far as we’re concerned, it’s been a little too quiet lately where FCPA enforcement is concerned, so we wouldn’t be surprised to see more activity in 2015. Don’t be surprised if we see actions against the handful of pharma companies that were accused of passing bribes in China in 2013.

Whatever 2015 brings, we’ll be writing about it through our weekly Compliance News in Review. Have a great year everyone and as always, thanks for reading!

Week in Review, December 10, 2014

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The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!

Week in Review, November 5, 2014

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The OECD questions Japan’s bribery law, OIG releases its 2015 Work Plan, CMS hopes to clarify the issues with data mingling, and Biomet settles False Claims Act charges against one of its subsidiaries.

Well, it certainly was a spooktacular weekend full of ghosts, goblins, and sugary goodies. November is upon us and Thanksgiving is just around the corner. But before we start the annual debates over canned or real cranberry sauce, or apple pie vs. coconut custard (a particular favorite at the Week in Review home offices), we have one more treat; this week’s News in Review.

The Organization for Economic Cooperation and Development (OECD) is taking issue with Japan’s ghost-like anti-bribery enforcement efforts. Japan does have a law prohibiting bribery of foreign officials, but it has done little in the way of enforcing that law. Under pressure from the OECD, the Japanese government developed a plan to increase enforcement, but the organization claims the law doesn’t address key issues, such as facilitation payment. The government plans to make more changes, but businesses are not waiting. According to Transparency International, a number of businesses are seeking guidance on how to develop effective anticorruption programs.

If you’re looking for a little something to help you take advantage of that extra hour of sleep we picked up over the weekend, the OIG has released its 2015 Work Plan. Sweet dreams.

CMS provided a few treats for applicable manufacturers and GPOs caught up in the data mingling issue that occurred during the inaugural submission of physician payments records. The agency has returned the report records to those affected and has given manufacturers and GPOs until March 31, 2015 to re-submit corrected records. A webinar for organizations with a returned record report is scheduled for November 13th and CMS is also providing a Validated Physician List in the Open Payments portal.

It wouldn’t be Halloween without a few surprises and CMS was happy to oblige. The agency announced several changes to the Sunshine Act Final Rule. The changes include the removal of the CME exemption; the deletion of the “covered device” definition; a requirement to report the marketed name and therapeutic area of a covered drug, device or biologic; and a requirement that stocks, stock options and any other ownership interest be reported as separate categories. The changes are effective immediately, but due to comments from industry CMS and the time needed to make changes to manufacturer systems, the changes will be implemented in the 2016 collection year.

On the settlement front, Biomet agreed to pay $6 million to settle charges it violated the False Claims Act. According to prosecutors, EBI, Inc., a Biomet subsidiary, provided kickbacks to encourage physician office staffers to use its bone growth stimulating product. The lawsuit was filed under the False Claims Act by a former product manager.

We close this week’s Review with a reminder that as you look to expand, supplement, or revamp your compliance curriculum, PharmaCertify™, from NXLevel Solutions, offers the off-the-shelf and custom training solutions you need to continually deliver critical compliance content where your staff needs it most – in the field and at their fingertips.

Have a great weekend everyone.