Author: NXLevel Compliance Team

Week in Review, January 14, 2013

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The PharmaCertify™ Team

Achoo! Sniffle…Cough…Cough. Hearing a lot of that these days? The seasonal flu is at a full on charge, and the vaccine is in shortage in some areas. The best thing to do these days is wash your hands often and invest in facial tissue manufacturers! While you get your broker on the line and sanitize your keyboard, take your mind off the germs and catch up on the week that was in this week’s News Week in Review.

The FDA may be cutting short sleep time for women dealing with the flu, especially for those who are taking drugs containing the active ingredient, zolpiden. Clinical studies found that even after a good night’s sleep, levels of the drug were high enough to cause impairment the next day. The FDA is requiring the recommended dosage for women be cut in half and the labels changed for any products containing the ingredient.

The Texas Medicaid system received a $36 million shot in the arm from Pfizer and Endo when the companies reached a settlement in a Medicaid fraud case. The companies were accused of misreporting prices of generic drugs to the Texas Medicaid system. Each company will pay just over $18 million plus attorney’s fee.

The U.S. Supreme Court has agreed to hear arguments in the case of the Federal Trade Commission vs. Watson Pharmaceuticals Inc., which deals with whether reverse payments violate anti-trust laws. “Reverse payments” arise when a company holding a patent pays a generic company to stay out of the market for a period of time. Arguments are scheduled for late March.

It’ll take more than some Vitamin C and chicken soup to cure what is ailing a group of pharmaceutical executives in S. Korea. A group of current and former executives from the country’s largest pharmaceutical firm, Dong-A, were indicted for providing kickbacks to hospitals and clinics. The group is accused of providing $500,000 in goods and services, which included the remodeling of a hospital.

Apparently, Google may have passed a “virus” to UPS and FedEx. The two carriers find themselves in the throes of an investigation for their part in aiding and abetting the illegal sale of drugs by online pharmacies. Google settled similar charges in 2011, and some believe UPS will settle again. FedEx will fight the charges saying, “settlement is not an option when there is no illegal activity.”

You know what else is as widespread as the flu? Answer: False Claims Act recoveries. And by “widespread” we mean record breaking. In fiscal year 2012, the government brought in an eye-popping $5 billion in FCA recoveries. This brings the four year recovery total to over $13 billion. The DOJ is devoting more resources to investigating and prosecuting fraud and whistleblower filings are on the rise, so the upward trend is likely to continue. Qui tam relators also did quite well in 2012, receiving $439 million in share awards.

That brings us to the end of this week’s Review. Speaking of under the weather – how is your compliance training curriculum feeling these days? Could it use a shot in the arm? A little refresher perhaps? PharmaCertify offers the custom and off-the-shelf training needed to help ensure your reps have access to critical compliance content, when and where they need it most – in the field and at their fingertips.

Have a great week everyone, go wash those hands, and we’ll see you back here next week!

Week in Review, January 7, 2013

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The PharmaCertify™ Team

Despite the doom and gloom “allegedly” predicted by the Mayans, 2013 arrived, and we’re all here raring to go for a new year! Well, maybe not raring…quite yet, but there is something rejuvenating about the turn of the year isn’t there – contemplatively looking back on the past year while looking ahead to the new year with hope. So time marches on, and so does the news. Let’s take a look at the happenings between the holidays in this week’s News Week in Review.

Victory Pharma didn’t go out on the happiest of notes in 2012, agreeing to pay $11.4 million to settle criminal and civil allegations surrounding the marketing of several of its products. Of the total settlement, $1.4 million was to resolve criminal allegations of violating the Anti-kickback Statute. The remaining $10 million is to resolve allegations of violating the False Claims Act. The case was brought by a whistleblower who was a former company sales representative.

And speaking of sour notes, 2013 didn’t start happily for a physician who blew the whistle on Amgen. A circuit court has denied the NJ physician’s petition for a court hearing to challenge the government’s recent $612 million dollar civil settlement with the company. The physician claims the government told him to either agree with the settlement or face the possibility of seeing his case dismissed. He declined to sign on, and now the government has asked the court to dismiss the case against Amgen. A lawyer for the physician says his client did not agree to the settlement because government prosecutors would not inform him of his share of the settlement.

A new survey from Ernst and Young shows that mid-market UK companies need to put learning about the UK Bribery Act on their resolution list for 2013. The survey of procurement managers and directors reveals that 64% of mid-market companies do not understand the law. Of those familiar with the law, just over half vet their suppliers for information on how to comply.

As you may know, in December of 2012 Eli Lilly settled allegations of violating the FCPA. In case you haven’t had time to read the enforcement action against Lilly, we have good news for you; Tom Fox has posted a brief video with an overview of the enforcement action, along with the specific internal audit function lapses cited by the government.

The American College of Obstetrics and Gynecology (ACOG) is ringing in the New Year with an update to its policy on professional interactions with the industry. The new policy encourages ACOG members to refrain from taking part in speaker’s bureaus; discourages professionals from accepting gifts (including meals) tied to promotional information; and encourages the provision of  vouchers or samples only to those with a “true need.”  The new policy also encourages physicians to  attend device training conducted by a professional association that has CME accreditation or only attend training focused on the FDA-approved use of the device. The policy also covers ghostwriting and research.

So is the idea of updating your compliance courses on your list of 2013 resolutions? How about investigating mobile technology for expanding the delivery of compliance content? Pharmacertify can help, with custom and off-the-shelf solutions designed to integrate compliance training throughout your company. Check out our course listing and mobile learning options at www.pharmacertify.com.

Happy New Year from all of your friends at the News Week in Review! Have a great start to the year everyone.

Week in Review, Fa-la-la-la-la Edition

NXLevel Compliance Team

The PharmaCertify™ Team

Stockings hung? Presents wrapped? Run out of ideas for your Elf on a Shelf? Christmas Day is just about here! Woo Hoo! But before visions of Sugarplum Fairies begin dancing (rule 1, stay away from the punchbowl at the office party) or you face the challenge of another gingerbread man, we have some news from the world of compliance. We know it’s not necessarily as much fun as popping another rum ball, but it’s definitely more fun than facing the crowd at mall. So grab a cup of eggnog and check out the news that was in this week’s News Week in Review.

Break out the Christmas Crackers, our first story takes us across the pond to the U.K. Since the U.K. Bribery Act went “live,” there hasn’t been much noise on prosecutorial front. But don’t let the silent act fool you, there were a number of  significant developments with the law.  The Serious Fraud Office (SFO) issued new guidance and guidelines, largely revolving around self-reporting. The new head of the SFO made it clear that self-reporting was not a guaranteed way to avoid prosecution.

Now we’ll pass the paper crown over to the folks from the land down under. The Australian Competition and Consumer Commission (ACCC) has approved a pharmaceutical industry Code of Conduct, which will require companies to disclose how much they pay physicians in speaker fees and sponsorships to attend medical conferences overseas. The ACCC gave the industry two years, instead of the five that had been requested, to come clean on the payments.

Speaking of physicians, pharma, money and conflicts of interests, a joint analysis by the Milwaukee Journal Sentinel and MedPage Today found that committees responsible for writing treatment guidelines are rife with physicians who have financial ties to the pharmaceutical industry.  In their analysis, the publications looked at treatment guidelines for 20 of the top 25 drugs sold in the U.S. They found that the committees to be largely populated by doctors with ties to the industry and some panels did not require doctors to disclose those ties. In addition, guidelines were sometimes written without scientific evidence showing the drug is safe for use.

Cash for Christmas: some think it’s a thoughtless and callous idea, others think it’s filled with logic. We think the feds may be in the latter camp considering the number of settlements announced recently. This week’s givers are Amgen, Sanofi and after much wrangling, Orthofix.

Amgen will pay $762 million to resolve criminal and civil allegations it illegally marketed one of its products. The company pled guilty to misbranding and will pay $150 million in criminal fines and forfeiture. The remaining $612 million of the settlement is to resolve civil claims.

Sanofi will pay $109 million to resolve allegations that it violated the Anti-kickback Statute and False Claims Act. According to the DOJ, the company provided free samples of product to physicians in order to induce them to purchase the product. The company also submitted a false Average Sales Price (ASP) to the government.

Orthofix gained court approval on a $43 million settlement in an Anti-kickback case and the company will pay $7.6 million in criminal fines and $32.3 million to settle civil allegations. The whistleblower case alleged sales reps submitted false certificates of necessity to Medicare for several of the company’s bone growth stimulators. The company pled guilty to failing to disclose the information during a Medicare audit in 2008.

2013 planning and resolutions are in the air at the various government agencies who handle compliance matters. At the Food and Drug Law Institute’s “Enforcement, Litigation and Compliance” conference, Greg Demske of the OIG said the agency hopes to hold more roundtables with the industry in the coming year. Michael Blume of the Consumer Protection Branch (CPB) of the DOJ, discussed whistleblower cases and said CPB will most likely start imposing its own requirements on companies, in addition to those imposed by the OIG through CIAs.

The recent U.S. v. Alfred Caronia decision was a hot topic at the conference as panel members suggested the ruling could have implication on future calculation of damages to the government, particularly when false claims are involved.

That brings us to the end of this week’s Review. Time for us to sled off into the weekend and toward a joyous holiday! Or perhaps to fit in one more last minute trip to the mall.

Have a save and very Merry Christmas everyone!

The Year in Review

NXLevel Compliance Team

The PharmaCertify™ Team

(Hey, everyone does one. Why shouldn’t we?)

We’re shaking things up a bit. Rather than bring you our weekly review of the news from the world of life sciences commercial and corporate compliance, we’ve decided to take a look back at 2012. That’s right, this week we’re bringing you a “Year in Review.” We’ve selected a few key developments that stood out as noteworthy and very well may shape the landscape of compliance going forward. So, settle in and fire up Call Me Maybe (The song of 2012. This is a safe space, you can admit you downloaded it) in the background, and join us for our first Year in Review.

First up is GSK’s $3 billion settlement with the DOJ. According to the DOJ, GSK illegally promoted certain drugs, concealed safety data and falsely reported prices to the government. While the fines and penalties involved were record breaking, what made this case notable was the resulting Corporate Integrity Agreement with the OIG. Two of the new provisions in the CIA involved compensation. First, the OIG usurped GSK’s change in its incentive compensation plan for sales representatives and made it part of the CIA. The OIG also required GSK to set up a program to recoup bonuses and long term incentives of any executives found guilty of misconduct.

Time will tell if the GSK provisions will only be implemented in the more “egregious” cases going forward, or will become the norm. Either way, the OIG has sent a message that the industry does need to examine how it handles incentive compensation for executives and customer-facing employees.

In 2012, we witnessed the release of the long-awaited DOJ guidance on the Foreign Corrupt Practices Act. One year after an update was promised by Assistant Attorney General Lanny Breuer, the DOJ delivered the document. While the guidance was largely a restatement of existing prosecutorial thinking from the DOJ and SEC, it did provide clarity on some issues, like the definition of foreign official and successor liability. The document also included a number of helpful case studies regarding the provision of gifts and entertainment.

The lack of movement on the Sunshine Act is our next big story for 2012. CMS had provided the draft rule for the Sunshine Act in December of 2011, and at that time delayed the data collection start date until after publication of the final rule. Comments on the draft were then submitted by various stakeholders and we expected a final rule to be published in April of this year. Well, the final rule languished, and CMS eventually pushed back the data collection start date to January 1, 2013. There was plenty of finger pointing, with legislative types coming down on CMS and CMS blaming the Office of Management and Budget. In November, the OMB owned up acknowledged that it had received the final rule November 27th and would be reviewing the document. (Please note – OMB has 90 days to issue the final rule.) So here we are, nearly a year later, still no final rule, and data collection is just around the corner. Stay tuned. Who knows, maybe Santa will bring us all a final rule for Christmas.

We complete our look back at 2012 with the recent developments in the U.S. vs. Caronia off-label case, which could also be known as “FDA Regulations vs. the  First Amendment.” For now, the First Amendment is winning. The U.S. Second Court of Appeals overturned a lower court decision, saying the previous conviction violated Mr. Caronia’s First Amendment rights. The case was sent back to the lower court to be re-tried. In its decision, the Appellate Court said that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA approved drug.” The court does not believe the FDCA precluded the sharing of truthful information about off-label uses of FDA approved drugs. While off-label promotion cases have been the bread and butter for government efforts the last several years, most companies choose to settle rather than go to court over the interpretation of the law.

Since this is an Appeals court ruling, the decision only applies to handful of jurisdictions, although some legal experts have suggested this could end up before the Supreme Court. Do you get the feeling we might still be talking about this one as a top story in 2013?

Well, that brings us to the end of our Year in Review. Are there any big stories we’ve missed? Feel free to comment on this blog, hit us up on Twitter (@pharmacertify) or start the conversation in our LinkedIn group. We’d love to hear from you!

Thank you so much for checking in with us weekly as we review the news nuggets from around the world of corporate and commercial compliance. We hope 2012 was a great year for you and yours and best wishes for a safe and joyous Holiday Season!

Compliance and the Petraeus Scandal

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By Lauren Barnett

PharmaCertify™ Compliance Specialist

CBS Moneywatch recently ran an article about the lessons businesses could learn from the situation that brought on the resignation of General Petraeus as Director of the CIA. Is there a compliance lesson to be learned here? If we look at the situation through the corporate lens and skip past the “soap opera” elements, we have a classic whistleblower situation. Let’s set the scene.

Person P is a high ranking, highly esteemed individual knocking on the door of the c-suite. As it turns out, Person P and Person B are engaged in some sort of activity that is at best unethical, and at worst, illegal, and that activity could cause a problem with the government. Person K knows about it, but doesn’t feel the need to say anything until Person B starts dishing out threats; perhaps saying to keep quiet, or threatening Person K’s position within the company. Person K decides the time is right to come forward and report the threats, as well as the activity of Person P and Person B. The investigation eventually results in Person P resigning his position.

So what went right? First, Person K identified the questionable activity and had access to a method for reporting it. Through training provided by the company, Person K knew the activity was not permitted. The company had procedures in place  to allow Person K to report the issue, and also created an environment in which Person K felt comfortable coming forward to report the issue.

Second, the report was taken seriously and was investigated. The high ranking status of Person P was a non-issue and the evidence brought forward was not swept under the rug to protect Person P.

Third, there were repercussions (as far as we know) for Person P and for Person B. Again, the rank of Person P was not an issue. We don’t know if the company allowed Person P to resign or if Person P saw the writing on the wall and chose to leave before the company imposed its own discipline. In either case, there was no effort to cover up the situation or simply slap Person P on the wrist.

Sounds like a textbook handling of the situation, right? Well not completely. Unfortunately, Person K didn’t come forward as soon as she knew Person P and Person B were involved in unethical or illegal activity. She waited until she was  threatened to file a report. Maybe Person K simply didn’t care about the activity, despite the fact it could mean trouble for the company. Or, perhaps she feared retaliation or assumed no punishment would occur due to the status of Person P.

Communication is key. Employees need to know the policies apply to everyone, regardless of rank or their perceived value in the company. The policies regarding the protection of those who do come forward also need to be communicated throughout the organization.

These situations are never easy, and admittedly it can be daunting for employees to come forward. (And if we’re being honest here, whistleblower awards from the government don’t make it any easier.) It all starts with training and communication about what constitutes appropriate behavior and the responsibility of each employee to ensure that business is conducted appropriately. Whether through an open door policy and/or an anonymous reporting hotline, employees need a clear pathway to report problematic behavior. However, it will all be for naught if the company doesn’t take reports seriously, conduct a thorough investigation and then act to correct the behavior.

Week in Review, December 10

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The PharmaCertify™ Team

Tis the season for giving. And if you ask us, “giving” represents the best part of the season. Sure, there’s the stress of coming up with just the right gift for that friend who doesn’t want to offer any hints, or the pressure of deciding whether to pick from the pile or “steal” from your coworker at the company’s yearly White Elephant. So before you’re faced with such daunting decisions as whether a Chia Pet or Pet Rock (how’s that for a dated reference?) makes more sense, we offer our gift to you: the week’s News in Review.

We begin with the week’s big surprise gift. The Second U.S. Court of Appeals overturned the conviction of a former sales representative for promoting a product off-label. The court agreed with the sales rep’s contention that his First Amendment rights were violated and the case was sent back to the lower court for reconsideration. The court also cited the reversal of Vermont’s data mining law by the Supreme Court in support of its decision.

Speaking of First Amendment cases, a former InterMune executive is appealing his conviction for wire fraud, which was based on a press release that touted the use of one of the company’s products for unapproved uses. The executive’s argument is based on his right to express a scientific opinion and the government is arguing that the First Amendment does not protect fraudulent speech, even if it “concerns scientific matters.”

While some may consider the FCPA guidance to be a gift that keeps giving throughout the year, the pharmaceutical and medical device industries would be hard pressed to agree. Michael Volkov, partner at the law firm, LeClairRyan, points out that the guidance confirms that life sciences professionals are operating in a high risk environment, where interactions with physicians can be problematic in regard to the FCPA. Volkov cites three takeaways for pharma and med device. First, doctors are foreign officials or instrumentalities and nothing in the guidance indicates that the government intends to back away from that position. Second, companies are liable for their distributors and sub-distributors and due diligence is a must when doing business overseas. Third, companies need to be careful when considering medical conferences, since foreign doctors have significant expectations for company-sponsored attendance.

Healthpoint Ltd. and DBF Pharmaceuticals picked the gift that no one wants; a fine. The companies agreed to a settlement of up to $48 million to deal with False Claims allegations over the product, Xenaderm. The government contends that the active ingredient in Xenaderm was found to be less than effective for its intended use in 1970, making the ointment ineligible for reimbursement by Medicare and Medicaid. Further, the companies were not forthcoming about the regulatory status of the ointment, causing false claims to be submitted to the government. The companies will pay $28 million to resolve the allegations, with another $20 million to be paid if either of the companies experiences a change in ownership over the next three years.

It’s time to tie the last ribbon and bow onto this week’s News in Review. Remember, if iPads are on the gift list for your sales reps this year, PharmaCertify offers the app development and mobile training programs you need to ensure critical compliance information is at their fingertips year round.

Have a great week everyone, and happy giving…and we suggest the Chia Pet.

Week in Review, December 3, 2012

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The PharmaCertify™ Team

Thanksgiving is behind us and now we move on to other celebrations of the season. As December kicks off, so do the many Christmas parades in towns, cities and theme parks around the country. And who doesn’t love a parade? We can’t wait for the colorful floats, marching bands, and classic cars, while we stand for hours in the cold, breathing in the fumes from the tractors pulling the floats, getting pelted by candy thrown from the floats by overzealous scouts. What’s not to love.

Speaking of causes for celebrations, we begin this week with the big news that the Office of Management and Budget is now in possession of the final rule for the Sunshine Act. CMS says the final rule will be published by the end of the year. (is that the sound of skepticism we hear out there?) Data collection begins January 1, 2013.

The speaker’s bureau parade is coming to an end for faculty at the Oregon Science and Health University. The proposal prohibiting faculty from serving as paid speakers for pharmaceutical companies is expected to be approved in the next couple of months. A petition supporting a ban on participating in speaker’s bureaus was signed by over 100 students at the University earlier in the year. Not everyone is thrilled with the idea. The faculty responsible for the presentations is concerned that the information they share during lectures will be delivered by less qualified physicians.

The OIG has billions of reasons to celebrate this season. In its semi-annual report to Congress, the agency lists expected recoveries totaling $6.9 billion among its accomplishments for the second half of the fiscal year. The OIG identified $8.5 billion in savings for the government, and that they excluded over 3,100 individuals from federal healthcare programs.

The OIG also informed Tennessee that the state’s false claims act needs work. In 2011, the agency notified several states their laws regarding Medicaid false claims were not as stringent as the federal law and they needed to bring the laws up to snuff in order to receive additional recovery money. Tennessee amended its law, but the OIG says the amended law does not offer enough protection for whistleblowers.

On the anti-bribery front, a drilling company located in Scotland became the first company to negotiate a settlement under the UK Bribery Act. The company will pay £5.6 million, the amount of profit gained through the bribes, and will not face further investigation.

In FDA news, the OPDP issued an untitled letter to Cornerstone Therapeutics addressing a pitch letter generated by the company, which allegedly contained false and misleading information and  unsubstantiated superiority claims. It’s rare to see an FDA letter issued against a PR piece, as FDA enforcement tends to focus on non-PR pieces.

That’s all for this News in Review folks. Have a great week and remember, as you map out your 2013 compliance training, PharmaCertify offers the custom, off-the-shelf, and mobile training you need to help ensure your team has the latest in compliance content integrated into their daily work lives.

See you next week!

Week in Review…Gobble Gobble Edition

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The PharmaCertify™ Team

Now is the time to shine up the good silverware, dust off that carving knife and fetch the stretchy pants from the back of closet. Thanksgiving is upon us! Bring on the food, family, friends and football. While we’re not quite ready to  start de-frosting the turkey, we are ready to give you a run down of the week that was. So pull up a chair, tie your napkin round your neck and get ready to feast on this week’s News Week in Review.

We’ll start with a little blurb, or appetizer if you prefer, of a story regarding the future of current HHS Secretary, Kathleen Sebelius. While it’s common for much of the top brass of any administration to move on at the start of a second term, there are no such whispers of a move for Ms. Sebelius. She’s expected to remain at least long enough to see the healthcare law implemented.

Like the Pilgrims, our next stories come to us from Great Britain. GSK was found guilty of three breaches of the ABPI Code. The breaches involve off-label promotion of the company’s platelet drug, Revolade and the revelations were the result of a company whistleblower. GSK was found to have breached multiple clauses, including the promotion of drugs for licensed uses (US only) and the requirement for sales reps to adhere to the ABPI Code.

GSK also agreed to a $90 million settlement with a 38 states over charges that the company illegally promoted Avandia. The states accused the company of inaccurately representing the risks associated with the drug in its marketing materials. A GSK spokesperson said the company chose to settle rather than go through expensive litigation, and the company admits no wrongdoing or liability under the states’ consumer protection laws.

Other side dishes of the week included Pfizer’s settlement of a Wyeth shareholder suit concerning misleading information about the risks associated with use of the antidepressant Pristiq. Plaintiffs claimed that Wyeth caused the price of the stock to be inflated during 2006 and 2007 by failing to release information about adverse events in a timely manner. The company also announced that the Wyeth unit will plead guilty to a misbranding misdemeanor charge as a part of its $491 million settlement with the government over the organ transplant drug, Rapamune. On the other side of the coin though, a whistleblower suit against Pfizer for its promotion of Lipitor was dismissed. A former Pfizer executive had accused the company of using a variety of illegal schemes to boost sales of drug, including kickbacks, misleading doctor education and unlawful sampling.

The main course of the week had to be the release of the long awaited guidance from the DOJ and SEC on the FCPA. If the tryptophan in the turkey doesn’t put you to sleep, you can always take a gander at the 130 page document here.

The day after the release of the document, Lanny Breuer of the DOJ and Robert Khuzmani, SEC Enforcement Division Director, held a press conference to discuss the guidance. Breuer claimed the guidance did not represent a “change in policy.” Khuzmani echoed his sentiments and said the “real value is clarity and transparency.” When asked why a more definitive line was not drawn on just who constitutes a foreign official, Mr. Khuzmani said there were many ways the control of an enterprise could be established, some of which are indirect.

You can find morel thoughts from the FCPA experts here and here, or check out this nice summary from the WSJ law blog.

Every holiday celebration has that one guest you hope doesn’t show, and in the view of one doctor, where the Sunshine Act is concerned, that “guest” is the CMS’ Center for Program Integrity (CPI). CMS has tasked the CPI with collection and dissemination of the spend reports related to the Sunshine Act. What’s the big deal? In an editorial on Amednews.com, the physician says the appointment of the CPI is troubling because it’s the anti-fraud unit of CMS. This gives the impression that any doctor appearing in the public reports will be cast as being involved in unethical behavior. He suggests that the data collection, distribution and appeals be assigned to a different division and compliance with the law be left to CPI.

The Sunshine Act is not the only morsel to come out of the ACA. Section 6004 of the ACA will also affect the industry in 2013. The section requires companies to submit a report of all their sampling activity to the FDA. The report must include: the name and quantity of drug samples requested; the name and quantity of samples distributed; the name, address, signature and professional designation of the person making or receiving the samples; and any other information requested by the Secretary of HHS. The government is likely to use the report to look for healthcare professionals who are abusing the sampling system.

No meal is complete without a really nice dessert, so in that spirit…the Massachusetts Life Sciences Center and the Massachusetts Medical Device Industry Council have teamed up to launch a mentoring program for veterans, aimed at helping returning soldiers return to civilian life. The initiative is part of AdvaMed’s Medical Technology Veterans (MVP) program, and will train 50 Massachusetts veterans for jobs in the med tech workforce. According to the organizations, a number of veterans already have the skills needed to work in the medical technology industry. The groups will hold a free, one day seminar in February.

And while we’re on the subject of the MVP program, AdvaMed announced that they will launch a website for returning veterans interested in joining the medical device industry. The site was initially offered to 25 veterans back in the summer, but now the market has been expanded to any veteran interested in a med tech job.

That’s all the tasty offerings for this week. We hope you’re geared up for a great time with family and friends on Thanksgiving. We’d like to take a moment and tell you all how thankful we are that you stop by each week and reading our little tome. We enjoy bringing it to you. Happy Thanksgiving everyone!

Week in Review, November 12, 2012

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The PharmaCertify™ Team

It’s been a wild couple of weeks. Hurricane Sandy followed a nor’easter that the Weather Channel named Athena (really, TWC?), and that was followed up by “Brutus” (again, really?), which socked western states with snow. And somewhere in the middle of all of it, we had an election. We hope all of you affected by this weather are safe and life is getting somewhat back to normal. Time for a look a back to see what made news, other than the weather. Here’s this week’s News Week in Review.

The 6th Circuit Court of Appeals ruled last week that when the False Claims Act was amended in 2009, Congress essentially used the terms “claims” and “cases” interchangeably. (Interesting bit of trivia on the ruling; it came on the same whistleblower case that prompted the 2009 amendment to the law.) In a nutshell, when the change in the law came about, Congress said it applied to pending “claims” back to June of 2008 as well as all pending “cases” at the time the law was enacted. The 2009 amended law changed the definition of a “claim,” so enter the wild litigation. A federal district court said the new standard for a claim could not be applied to cases pending in June of 2008. The courts said if Congress had intended for that to happen they would not have used the word “claim” to refer to those cases. Enter the 6th Circuit, which upon examination of the statute, said Congress used the terms interchangeably.

In other legal news, an examination of the Boehringer Ingelheim settlement and CIA begs the question, are the feds really “done” with stepped up enforcement of off-label promotion cases? The BI settlement cited two types of false claims stemming from off-label promotion not generally seen in these cases. One involved promotion of products for higher dosage than what was on the label, but the false claim only applied to Medicaid and Federal healthcare programs other than Medicare – sending a signal that state Medicaid may play an increasing role in fraud investigations. The other involved claims of superiority, which are rare in False Claims cases.

Coincidentally, during her speech at the Pharmaceutical Regulatory and Compliance Forum, Mary Riordan, of the OIG, mentioned that the agency would be focusing on less traditional promotional issues in 2013, such as superiority claims. Her remarks also focused on the results of a February roundtable with compliance officers from pharmaceutical companies who were under CIAs. The session revealed that many of the participants wanted more direction from the government regarding promotion over social media.

Dierdre Connelly’s keynote address at PCF was focused on trust. Ms. Connelly said, “Trust is a two way street” and that GSK has changed as company, and that those who hold them accountable need to understand that. She went on to discuss the change in GSK’s sales representative compensation program. The change began with a discussion with New York sales reps, during which the reps pointed out their sales metrics did not align with their customers’ goals for their patients. This was preventing the reps from building a sufficient level of trust with their customer. The company has since changed how it compensates all sales representatives, and that change appears to be helping the company regain the trust of physicians.

During Ms. Connelly’s address she said, “fines and settlements do matter.”  The SEC and DOJ agree with her when it comes to fines levied against the industry in FCPA cases. The industry has come under fire in recent years for promotional activities outside the U.S. Millions in fines have been doled out against a handful of companies but some question if the fines are much of deterrent. A fine in the tens of millions of dollars against a company that brings in billions of dollars a year is not much of hit to the bottom line. A representative at the SEC said she believes the fines are making a difference. She adds, however, that if the SEC learned companies simply view fines as a cost of doing business, the amount of the fines would certainly rise.

That brings us to the end of this week’s News Week in Review. This week, we learned new ways enforcement agencies are viewing the impact of promotional activities on federal healthcare programs, in particular promotion for unapproved uses of product. As you keep this in mind when planning your 2013 training, Pharmacertify can help with custom and off-the-shelf training focused on on-label promotion and good promotional practices.

Have a safe and dry week everyone!

Week in Review, October 29, 2012

NXLevel Compliance Team

The PharmaCertify™ Team

Ghouls, ghosts and goblins are on the way. It’s Halloween – time to dress up and march the kiddies out for trick-or-treating. Then you’ll want to “inspect” their haul, and in our book, it just isn’t a proper inspection if there isn’t taste testing involved. Have you figured out your costume yet? While you mull over your ideas, we present the scary tales of the week that was…the News Week in Review.

The final rules for the Sunshine Act may be a barely more than a ghost of an idea at this point, but the American Medical Association has written to CMS to express concerns regarding the proposed rule. The AMA again expressed concerns about the accuracy and public perception of the data. The group urged CMS to make changes in physicians’ ability to review pharmaceutical and medical device companies spend data. The AMA would like to have access to companies’ databases and be able to refute the data before it becomes public. The agency fears the data could create misperceptions about the relationships between physicians and the industry.

All the information received from the Sunshine Act could be a treat for enforcement agencies. A client alert from Morrison and Forester summarizes a discussion from a recent conference on aggregate spend, at which a panel of representatives from healthcare fraud enforcement agencies discussed how the data could be used in identifying possible fraud. Enforcers said the data could be reviewed to determine if groups of physicians are being paid a disproportionate amount from a particular company.

It’s alive, well, at the federal and state level of governments. We’re talking about none other than the False Claims Act. Federal and state enforcers are getting more aggressive with their enforcement of False Claims Act violations, and with $9 billion in recoveries this year is it any wonder? Allegations of violations rarely stand a judicial test as most cases are settled. This allows prosecutors to push the bounds of how the law is applied. A federal appeals court recently reined in federal prosecutors though, as it rejected the government’s attempt to expand certain aspects of the law in recent renal care cases.

No trick here, the U.K. Justice Ministry is moving forward in making Deferred Prosecution Agreements (DPA) a tool in dealing with crimes such as bribery, fraud and corruption. The Justice Ministry sought feedback on the use of the DPAs, and 86% of those who responded said they would be in favor of the idea. Those who supported the use of DPAs believed they were a “pragmatic means of investigating and penalizing more corporate crimes.”

Boehringer Ingelheim will have a smaller bag of candy this Halloween, with the announcement of a $95 million settlement with the government for the illegal marketing of three of its drugs. The government alleged that BI promoted the drugs for off-label uses and paid kickbacks to doctors. The case was brought by former sales representative under the qui tam provisions of the False Claims Act of the company, and he will receive $17 million as a whistleblower award. The states will receive $16.5 million of the settlement.

That brings us to the end of our spooky tome. Before we wrap it up, we’d like to send out our best wishes for anyone in the path of the Frankenstorm, Sandy. With all the rain, surf, winds and snow, the next few days will be very difficult for all of us in the northeast. Stay safe everyone!