CMS

Compliance News in Review, June 16, 2015

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Dinosaurs roamed the earth again (at least in the land of movie theaters), over the weekend, with the release of the summer’s first big blockbuster, Jurassic World. You’d think after three films, the characters would have learned not to fool with Mother Nature. Apparently not, and considering the $200+ million the film racked up at the box office, we are not tired of watching them make those same mistakes.

It may not involve death, destruction and extinct creatures, but we have our own epic tale to tell. Break out the popcorn and 3D glasses, and silence your phones please. It’s time for this week’s feature presentation – the Compliance News in Review.

Transparency International is undertaking a project of Giganotosaurus proportions. At the International Pharmaceutical Compliance Congress and Best Practices Forum, Executive Director Robert Barrington spoke to attendees about corruption in the healthcare sector and an initiative underway to evaluate corruption in the pharmaceutical industry specifically. The project will focus on five key areas: procurement and distribution, manufacturing, marketing practices, product registration, and research and development. Barrington noted that the industry should prepare for more scrutiny, with patients demanding to know why increased spending has not led to an improvement in the quality of healthcare.

Public Citizen has accused the FDA of improperly expanding the original approved use of a sleep disorder drug, and has filed a petition with the agency to have the label changed. According to the organization, the drug was initially approved for use in treating the disorder, Non-24, in blind patients, however the drug’s label does not specify the patient population. Public Citizen says this opens the door to the drug being used for other sleep disorders with patients that are not blind. Following the initial approval, the FDA did send the manufacturer a second approval letter which stated a mistake was made and the drug was approved for treatment of Non-24 in general. The second letter notes that the condition is experienced almost exclusively by those who are blind.

Could this be another “blockbuster” decision by the FDA? The FDA sent a letter to Amarin Pharmaceuticals and the court in response to Amarin’s lawsuit against the agency for violating its free speech rights. The company would like to share study information showing its drug reduces the risk of heart attack when taken in conjunction with a statin, which is not an approved use. In its response to the lawsuit, the FDA says it does not have concerns with most of the information the company wanted to share, and it does not consider the sharing of that information to be false or misleading. The letter also reminded the company that new guidelines for sharing off-label information are forthcoming.

In our opinion, the letter from the FDA to Amarin is certainly not an invitation for pharmaceutical and medical device companies to start sharing information about unapproved uses of their products. Situations like this, as well decisions like the Caronia case, may lead some to think the rules have changed, when in fact they have not. Training and communication efforts need to emphasize that the laws and regulations remain the same. Promotional statements still need to be truthful, accurate, not misleading and balanced.

The message should be clear – only company approved studies and statements may be shared, and done so in the way described by the company. The way in which companies play the game may be evolving, but the rules of the game remain the same. Playing within those rules benefits all stakeholders, including the company, and most importantly, the patient.

Have a great week everyone!

Week in Review, May 13, 2015

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European Medicines Agency changes its conflicts of interest policy, ACCME updates its requirements related to the disclosure of commercial support, Siemens may be facing corruption charges in China, Bio-Rad tries to block access to FCPA settlement documents, the FDA schedules a summer session with stakeholders to discuss the topic of off-label, and another pharmaceutical company adopts the First Amendment argument in a fight to promote off-label.

Well, the world welcomed a new royal at the beginning of May, and last week, we even learned the name of the latest little princess, Charlotte Elizabeth Diana. A lovely name for a lovely little girl, and a touching tribute to the proud papa’s mother. Of course, if you’re not an Anglophile, you undoubtedly couldn’t care less, so we’ll quickly move on to our own little bundle of joy…the latest version of the Compliance News in Review.

In other news from across the sea, the European Medicines Agency (EMA) has made changes to its conflicts of interest policy. The agency will no longer allow individuals with connections to the pharmaceutical industry, or those who know they will be working for the industry, to sit on drug review panels. The previous policy left that decision up to the individual.

The ACCME has issued a royal proclamation updating its requirements for disclosure of commercial support. CME providers will now be allowed to use tabs, hyperlinks, or other electronic means to communicate commercial support to attendees. The ACCME says the move is an effort to “simplify compliance expectations and make them consistent across activity types.” The organization expects learners, as they always have, to receive disclosure information prior to the start of a CME session.

Siemens announced that its healthcare unit’s marketing and business practices are being investigated by Chinese regulators. The company denies media reports that the investigation deals with corruption, and says that it is working with regulators to resolve the matter. A Chinese government website stated that regulators were not investigating the company over bribery concerns. Siemens sells medical equipment and biochemical tests in China.

Bio-Rad raised the drawbridge on a records request from an investor. That investor has now filed a petition to have access to records related to Bio-Rad’s FCPA settlement. In 2014, the company entered into a non-prosecution agreement with the DOJ and accepted an Order issued by the SEC to resolve the matter. The investor made a request for records that related to the bribery allegations, but the company said there was no proper purpose for the records and the request did meet certain legal requirements.

The FDA will hold audience with the public during the summer to discuss off-label promotion. The agency says the meeting is being called to discuss the issue with a variety of stakeholders. The industry has been vocal about how the regulations infringe on First Amendment rights and have called on the FDA to relax its regulations. Critics worry that allowing companies to promote off-label will lead to less clinical trials and risks to patient safety.

One drug maker has decided to not wait for that summer meeting to take action. Amarin Pharma has filed suit against the FDA over its ability to share off-label information with physicians. Lawyers representing the company say the company is within its First Amendment Rights to share the information, as long as it is truthful and not misleading. The lawyers believe Amarin is the first company to pre-emptively sue the FDA over the issue. At the center of the suit is the company’s ability to share company-sponsored clinical trial information with doctors. The information indicated that the drug may be helpful for a wider patient population than what was approved. Lawyers for the company say the company knows physicians are already prescribing the drug off-label for a wider patient population, and more information, not less, should be shared with the physicians. A director with the health advocacy group, Public Citizen, says if the suit succeeds, it will undermine the FDA’s drug approval process. The FDA had no comment.

With that news of the on-going battle over off-label, we proclaim this issue of the Compliance News in Review as complete. Clearly, the focus on off-label isn’t going away anytime soon. That’s why we continually update our PharmaCertify eLearning module, On-label Promotion, with the content your representatives need to stay in compliance as they interact with HCPs.

Have a great week everyone!

Week in Review, April 27, 2015

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Teva settles a pay-for-delay case, the FDA migrates toward electronic submission of promotional materials, a circuit court rejects off-label claims against Medtronic, and several states introduce legislation requiring drug makers to release the costs associated with expensive drugs.

Lordy, lordy, King Arthur is Forty! Monty Python’s version of King Arthur that is. The comedy classic, Monty Python and the Holy Grail, is celebrating its 40th anniversary. If you’re not familiar with the film, forget what you think you know about King Arthur’s quest for the Holy Grail. This version certainly reveals a side to Arthur, his Knights and life in medieval Britain that has never been explored. Whilst we consider the merits of this classic comedic cinematic achievement, we’ll leave you with an epic tale of our own. To horse fine people…it is time for the Compliance News in Review.

Now this is a lot of coconuts. Teva has agreed to pay $512 million to settle a pay-for-delay case involving its Cephalon subsidiary. Drug wholesalers and retailers accused the company of paying generic drug makers to delay marketing a generic version of Provigil. The settlement is the largest in a pay-for-delay case.

The FDA has released new guidance that will make it easier for drug companies to submit promotional materials to the Office of Prescription Drug Promotion (OPDP). Currently, companies are required to submit promotional pieces through a paper-based process, using form FDA-2253. The new guidance offers instructions for submitting promotional materials using the FDA’s electronic common technical document (eCTD). The use of eCTD was mandated in the Food and Drug Administration Safety and Innovation Act. According to the guidance, in two years, all promotional materials must be submitted electronically.

They don’t have a shrubbery, but they would still like safe harbor. The National Infusion Care Association (NICA) has issued a paper arguing that OIG’s position stating that co-payment coupons and other financial assistance runs afoul of the Anti-kickback Statute (AKS) should not apply to specialty biologics for which there is no generic available. The OIG issued a report saying the coupons could be problematic under the AKS if they entice a patient to purchase a drug that is paid for by the government. NICA says while well intentioned, the position is really only valid if there is a generic alternative available for a specific drug. The organization claims that for many specialty biologics, no such alternative exists, and they worry that patients on government programs could be left with few treatment options if they are not able to accept co-payment coupons offered by manufacturers. NICA would like to see CMS, HHS, OIG and others in the government create a safe harbor allowing those on government programs to participate in co-payment programs if there is no generic alternative.

It may not have had the same drama as the process for determining if someone is a witch, but a circuit court has rejected claims against Medtronic over its off-label promotion of a medical device. The company was sued by an Oklahoma woman who said her physician implanted the product, Infuse, in a manner that was different than the FDA-approved approach. The woman said her doctor was urged to by a Medtronic representative to use the particular approach, and that the company had violated state tort laws. The court said her claims either did not have sufficient proof or were pre-empted by federal law.

Several states will soon be asking drug companies to bring out their drug costs. Massachusetts, North Carolina and Pennsylvania are the latest states to introduce legislation requiring manufacturers to disclose the costs and pricing information associated with expensive drugs. The Massachusetts’s bill will impose a limit on what a company can charge if the state determines the price of a drug is “significantly high.” If that bill is passed, the state will develop a list of drugs for which reporting is required. Companies will have to report costs related to production, research and development, and marketing. North Carolina’s law will require disclosure reports on all drugs sold in the state, and like Massachusetts, the production, research and marketing costs will have to be reported. Pennsylvania’s law will require disclosure reports for drugs with an average wholesale price of $5,000.00 or more, annually or per treatment. The Pennsylvania bill allows insurance companies and state programs to not cover a drug if the manufacturer has not filed a transparency report with the state.

With that, our tale for this week has nearly ended dear readers. We leave you with the reminder that many knights prefer accessing up-to-date compliance training whilst jousting about on horseback rather than hoping for a strong wireless connection over a mug of mead at the local tavern. The PharmaCertify™ suite of compliance-focused training solutions offers that training where your knights need it most – beyond the round table and at their fingertips.

Farewell for now dear friends.

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.”

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!

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.

Week in Review, September 30, 2014

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PhRMA and the DOJ argue the details of the Integrilin case, sentences and a fine are handed down in the GSK Chinese bribery case, more elected officials weigh in on the removal of the CME exclusion from the Sunshine final rule, and the OIG raises concerns over drug coupons and the potential for kickbacks.

The cosmos (and Starbucks – welcome back Pumpkin Spice latte) say fall is officially upon us! Cooler weather is on the way, and so is pumpkin picking and that extra hour of sleep. Time to gather around the fire pit and scarf down a few S’mores! But before we lose ourselves in a soliloquy about the magical mysteries of a great corn maze, we’ll navigate the twists and turns of this week’s News Week in Review.

There’s a certain chill in the air between PhRMA and the DOJ. A few weeks back, we highlighted the story about PhRMA filing a “friend of the court” brief in a whistleblower case involving the off-label promotion of the heart drug, Integrilin. The brief presented the claim that the whistleblower’s arguments raised free speech issues and the organization asked the court to reject the whistleblower’s claims . In a response, the DOJ said PhRMA’s brief did not establish a First Amendment violation. In fact, according to the agency, no precedent existed to support PhRMA’s argument that the False Claims Act could not have been implicated. PhRMA shot back, saying for a person’s speech to knowingly cause a false claim to be submitted there has to be a “direct causal nexus between the speech and the claim” and sharing peer reviewed journals with truthful information about an off-label use does not meet this requirement according.

The summer has ended, and so has the GSK Chinese bribery scandal, with a court levying a $500 million dollar fine against the company. The country manager for GSK and four other executives were found guilty and faced prison terms of up to four years. The Chinese court suspended the sentences, and declared that the country manager, a British national, could be deported. According to the court, all of the country manager and executives pled guilty and had no plans to appeal the verdict. The fine imposed on GSK is the highest fine the Chinese government has ever imposed in a bribery case.

On the Sunshine front, U.S. Representatives Michael Burgess and Frank Pallone sent a letter to CMS expressing concern over the removal of the CME exclusion from the final rule. The two representatives say the current rule provides a clear exemption for payments and transfers of value related to CME, while the proposed changes are ambiguous. Burgess and Pallone ask CMS to carefully consider the comments they have received from stakeholders about the proposed change. Representative Burgess also teamed up with Representative Allyson Schwartz to introduce legislation to exempt textbooks, indirect CME payments and journal articles from the Sunshine Act’s reporting requirements.

Industry trade groups are bobbing for an explanation, again, as to why nearly one-third of data submitted to Open Payment was removed from the system. PhRMA, AdvaMed, and BIO sent a letter to CMS reiterating concerns that the agency still had not provided an explanation as to what happened to the data. The groups are hopeful that the issue can be resolved quickly, so the public can be confident in the accuracy of the data.

According to a report from the OIG, the use of drug coupons could lead to kickback violations. The OIG investigated the use of coupons to purchase drugs covered by Medicare. Nearly 7% of senior citizens reported using coupons to purchase drugs covered by Medicare Part D. Coupons cannot be used to purchase items covered by Medicare Part D and inducing consumers to do so can be considered a kickback. The agency found inconsistencies in how drug companies implemented safeguards on their coupons. Printed coupons tended to have language advising consumers the coupons could not be used for Part D purchases, but only 80% of web coupons included the same language. In addition, nearly one-third of manufacturers surveyed did not include eligibility information for the pharmacists. The OIG recommends CMS work with drug makers to improve the process of identifying patient enrollment in Medicare Part D, and to improve the reliability of pharmacy claims.

FDA’s social media guidance left PhRMA feeling a little chilly. In comments submitted to the FDA, the organization expressed concern that the guidance discourages manufacturers from sharing meaningful information with patients on social media networks. According to the comments, the guidance, as written, places undue responsibility on the manufacturers for what users say about the products.

With that, we close out the post autumnal equinox edition of the Compliance Week in Review. Have a great week everyone and enjoy the colors of fall!