The 2016 Pharmaceutical Compliance Congress: a Preview

On April 26 and 27, compliance professionals and government representatives will gather in Washington, D.C. for the 13th Annual Pharmaceutical Compliance Congress. As usual, the conference offers a cornucopia of sessions and workshops focused on important compliance topics. There is plenty to see and learn, but here are the topics that have piqued our interests:

Day One General Session: FMV Considerations and Emerging Compliance Risk – In this age of transparency, FMV is a hot topic for life science companies and healthcare providers alike. This session, along with the breakout sessions on the same topic, offer a great opportunity to identify emerging risks related to FMV, and learn best practices from industry colleagues.

Day One General Session: EFPIA Initiatives for 2016 and Beyond — Charting the Course for Global Transparency – EFPIA members have completed their first year of data collection to comply with the Disclosure Code. We’re hoping to hear about the early challenges companies are facing and EFPIA’s plans for the future of its transparency initiative.

Day One Track: Product Promotional Compliance – In particular, we are interested in two sessions:

Social Media — New Challenges and Opportunities: While social media presents a unique set of challenges, its affect on life sciences marketing and compliance has to be taken into consideration.

Speaker Programs and Medical Roundtables — Environment and Areas of Risk: In this era of increasing scrutiny, we’re specifically interested in hearing about the emerging risks surrounding roundtables and the strategies for mitigating those risks.

Day One Workshop: Analyze FCPA Updates and Identify Areas of High-Risk to Mitigate Non-Compliance, paired with the Day Two General Session FBI address, International Corruption Squads – the FCPA and Beyond – At the end of 2015, the DOJ announced that it planned to hire 10 additional attorneys for its Fraud Division FCPA Unit. Also, the Serious Fraud Office entered into its first corporate Deferred Prosecution Agreement for violation of the U.K. Bribery Act last year. Enforcement of anti-corruption laws continues to be a priority for the U.S. and governments abroad. Learning about the emerging risk areas, and how various agencies cooperate in enforcement, is key to ensuring that your anti-corruption program is covering all the right bases.

Day Two Track: Fraud, Abuse and Kickback Prevention – The scrutiny of payments to physicians is only going to increase as more entities comb through transparency data. Concern from investigators and enforcement agencies about the potential for kickbacks is growing. The discussion on anti-kickback enforcement trends, and the establishment of compensation limits will be helpful when addressing your organizational kickback risks.

Day Two Discussion Group: Focus on Pricing – Considerations for Compliance as Scrutiny Heats Up – Last year, we saw the largest settlement ($12.4M) under the OIG’s Civil Monetary Penalties Authority. The settlement was over price misreporting, and enforcement in this area isn’t about to let up. This session presents a great opportunity to learn about best practices and the challenges compliance professionals are facing regarding government pricing.

Day Two Track: Compliance Program Structure and Effectiveness – Engage the Organization to Promote Ethics within Compliance

Okay, we may be a bit biased on this one, since Peter Sandford from NXLevel Solutions is one of the presenters, but as your training audience evolves, so should your compliance training. As millennials bring a new sense of energy and expectations to the industry, implementing modern and innovative learning strategies is more important than ever. Peter and his co-presenter, Jim Massey – Vice President, Global Compliance, Enablement & Assurance, AstraZeneca, will share five key principles for integrating creative and engaging compliance training into your organization.

We invite you to stop by the NXLevel booth to see demos of our compliance-focused training solutions and to share your thoughts on the sessions. And while you’re there, don’t forget to enter our drawing to win a Bose® SoundLink® Bluetooth speaker.

Stay compliant and we’ll see you in Washington!

Compliance News in Review, Ides of March Edition

BMS makes changes to its promotional spend policy in China, a physician is sentenced to prison for accepting kickbacks, and the FDA agrees to allow Amarin to promote its fish oil drug for off-label purposes.

“Beware the Ides of March,” and with good reason. Not only was Julius Caesar assassinated during the Ides, but Czar Nicholas II abdicated his throne, the Nazi’s occupied Czechoslovakia, and the issuance of global health alert concerning the SARS virus all occurred on that infamous date. While plenty of good things probably happened as well, we’re stocking up on horseshoes and four leaf clovers here at the News in Review headquarters, just in case. As we wait for the clock to tick down on March 15th, let’s look at the fortunes of those who made news in the world of compliance, with this edition of the News in Review (fingers crossed it isn’t all bad).

Advice from a soothsayer isn’t necessary for BMS to make changes to its promotional spending policy in China. The company will no longer pay speaker fees to doctors, and will be cutting is spending on entertainment and donations to medical associations due to red flags identified in its Chinese operations. This is second wave of changes for BMS in China, following the company’s settlement with the SEC over violations of the FCPA.

Misfortune has certainly followed one Chicago doctor into March. Dr. Michael Reinstein was sentenced to nine months in prison for accepting kickbacks when issuing prescriptions for clozapine. The doctor admitted to accepting close to $600,000 in kickbacks for prescribing the drug. The defense requested probation, but the judge rejected the request, saying Dr. Reinstein’s patients were among the most vulnerable in society and he violated the trust of those patients when he accepted the kickbacks.

The news isn’t all bad in the Ides, though. The FDA has agreed to allow Amarin to promote its fish oil drug for off-label purposes. Amarin filed suit against the FDA claiming the agency was violating its free speech rights by trying to restrict the company from sharing truthful off-label information in its promotion of the drug. The FDA agreed to be bound by the decision issued in US District Court, which allowed the truthful off-label promotion of the drug. The agency says “the settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.”

As witnessed by the FDA’s statement on the Amarin settlement, a definitive stance regarding the use of off-label information when promoting a product seems to still be a moving target. While companies and legal-types debate how this decision, and other free-speech cases, should be interpreted and applied, we see it as another opportunity to highlight all the legal requirements around product promotion. Providing fair-balance, making accurate, truthful and not-misleading statements are just as important when promoting a prescription drug or device. As an example, notice of violation letters sent by OPDP in recent years typically site inaccurate and misleading statements as the reason for the notice.

With that, we put a green ribbon on this “pre” Saint Patrick’s Day edition of the Compliance News in Review. Here’s hoping the Ides treat you well. Have a great week everyone and stay compliant!

Compliance News in Review, June 5, 2015

Cephalon settles a generics case with the FTC over its sleep disorder drug and the OIG releases its mid-year update to its 2015 Work Plan, and we offer our take on how it impacts training.

Well, the summer blockbuster season is almost here. Superheroes, Sundance darlings, reboots and rom-coms will all be competing for our attention and discretionary dollars (is that a contradiction in terms?). While it may not carry the cache of the newest Clooney or Cruise release, we proudly offer our own little feature for your entertainment and edification…the latest edition of the Compliance News in Review. On with the show!

It’s finally a wrap on the Federal Trade Commission’s case against Cephalon. The FTC settled its pay for delay case with the company (now part of Teva) for $1.2 billion. The case involved Cephalon’s attempts to delay entry of generics for its sleep disorder drug. The settlement is the largest ever secured by the FTC.

The OIG has premiered its mid-year update to its Fiscal 2015 Work Plan. The update includes several new items, one of which is a review of the financial interests reported via Open Payments.

We will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program. We will also determine the extent to which CMS oversees manufacturers’ and group purchasing organizations’ (GPOs’) compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.”

The OIG’s report on its findings is expected during fiscal year 2016. As Policy and Medicine points out, it will be interesting to see what sort of enforcement follows the OIG’s review, and if the information is used by the agency for its other activities involving fraud and abuse. This potential for enforcement involving this data should not be overlooked.

The first full calendar year of data has not even been released to the public yet, and the OIG is jumping right into a review. The agency’s actions underscore the importance of accurate data and the need for training to ensure that accuracy. From those engaging in transactions with covered entities, to those responsible for the reporting on the back end, understanding data collection and reporting requirements is critical. In addition to in-house staff, third-party vendors and partners that may be involved in reportable transactions on a company’s behalf need training on the basic requirements of the Sunshine Act and Open Payments.

Enjoy the weekend everyone, and we’ll see ya at the movies!

News Week in Review, February 18, 2015

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!

Week in Review, September 17, 2014

A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant company, the FTC accuses two companies of trying to stymie generic competition for Androgel, and a collection of advocacy groups ask CMS for an indirect payments exemption.

Ahoy there mateys! Stand fast, secure the rigging, and let us hear your best “arrr.” Yes, “Talk Like a Pirate Day” is on the horizon. As you prepare to weigh anchor and hoist the mizzen, we strongly recommend you avoid the parrot on the shoulder idea – that didn’t end well for one of the old salts here at the Week in Review offices last year. The big day isn’t until Friday, so we’ll fill the time with this week’s Compliance News in Review.

It’s not the amount of treasure involved, but rather the type of treasure, that may be more influential in the decisions made by FDA panel members when they decide which drugs to recommend for regulatory approval. A recent study found that panelists who have financial ties only to the drug manufacturer seeking approval are 1.5 times more likely to vote favorably for the company than members with no ties. However panelists who have ties to the company seeking approval and its competitors are no more likely to recommend for approval than those panelists who have no ties. Panelists with multiple relationship may not have a sense of loyalty to any one particular manufacturer. In addition, panelists who serve on advisory boards are more likely to approve a drug than panelists who have research or consulting relationships with the manufacturer.

A physician and spinal implant company have found themselves on the wrong end of a hornswaggle claim by the Department of Justice. The agency has filed a False Claims Act suit against a Michigan neurosurgeon, as well as spinal implant company, Reliance Medical Systems, and two of its distributorships. The company is accused of paying kickbacks through physician-owned distributorships (PODs). The government alleges that the company set up the PODs to induce physicians to use its spinal implants. The physician involved received payments through a POD in which he had an ownership stake. He is also accused of performing unnecessary procedures on patients who did not need spinal implants.

The Federal Trade Commission (FTC) is suing Abbvie and Besins Healthcare for running a rig and trying to prevent generic competition for the product Androgel. The agency claims the companies filed baseless patent infringement lawsuits in an effort to prevent potential generic competitors from entering the market. While the lawsuits were pending, Abbvie then entered into a pay-for-delay deal with Teva in order to postpone the launch of its generic version of the product. The FTC is asking the court to declare that Abbvie and Besins Healthcare violated the Federal Trade Act, and is seeking disgorgement of profits.

The mutiny against indirect payment disclosures under Sunshine continues to grow. A collection of 64 patient advocacy groups sent a letter to CMS requesting an exemption for indirect payments to the groups. The letter claims drug and device manufacturers have no discretion on how funds provided to patient advocacy groups are directed. It also suggests that the process of determining how a manufacturer’s funds are allocated places an unnecessary administrative burden on the groups.

As we heave to on this week’s journey into the world of compliance, we end with a question: arrr your sales representatives prepared with the up-to-date content on topics like the Sunshine Act, HIPAA, and Good Promotional Practices? The PharmaCertify™ suite of solutions offers your team compliance-focused information where and when they need it most – in the field and at their fingertips.

Have a great rest of the week everyone.

Week in Review, May 5, 2014

UCLA settles with a surgeon over conflicts of interest, CMS announces a timeframe for Phase 2 of Open Payments data submission, qui tam lawyers pour through the recently released Medicare payment data and PhRMA weighs in on simplifying product warning information.

Not so long ago in a galaxy…well, right here…the greatest achievement in cinema was celebrated (yes, we’ll admit it, we’re often given to hyperbole). With all due respect to Bogie and Bacall and Orson Welles, we’re of course referring to this past weekend when the Fourth of May was with us, and we celebrated Star Wars Day. Then, on Monday we had to deal with the Revenge of the Fifth. Rather fitting don’t you think? If Star Wars isn’t your particular cup of blue milk, feel free to jump right to the earthly compliance news of the week with this issue of the News in Review.

10,000 credits in advance may get you a ride on the Millennium Falcon, but it took 10 million dollars to settle a retaliation suit between a UCLA surgeon and the University of California Board of Regents. The surgeon, who was head of the orthopedic surgery department, raised concerns about physicians’ financial relationships with medical device companies. He claims his complaints were ignored and he was then denied patient referrals and prevented from participating in grants. In settling, UCLA claims it chose “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”

Open Payments: Episode 2, coming soon to an industry company near you. CMS has announced that applicable manufacturers can expect Phase 2 of Open Payments data submission to be open late May or early June. During Phase 2, applicable manufacturers and GPOs should:

  • Register any authorized officials not registered during Phase 1
  • Complete the registration for entity and the authorized official (supplemental information is required)
  • Verify entity profile information is correct
  • Upload, verify and attest to accuracy of payment data

Additional roles within the Open Payments system may also be assigned during Phase 2. CMS is preparing tutorial videos to assist applicable manufacturers and GPOs with implementation.

Qui tam lawyers have been mining the recently released Medicare payment data almost as aggressively as the Empire mined the Tibanna gas mines at Bespin (wow, we went full out geek there). The organization known as Taxpayers Against Fraud has lawyers pouring through the data looking for physicians who prescribe high numbers of a particular product. Obtaining this type of data previously required a subpoena. Is this a foreshadowing of what to expect once Sunshine data is released? Sunshine data might be used to demonstrate alleged instances of kickbacks, or infer that a company is involved in off-label marketing when a physician’s specialty doesn’t align with the approved use of a product.

They may not be well-liked by the hard core fans, but the Ewoks certainly proved the power of “keeping it simple.” Seriously, a bunch of teddy bears held off the Empire with rocks and logs! PhRMA appears to share this simplicity sentiment when it comes to the warnings in DTC ads. When the FDA asked for comments regarding a study focused on whether simplified warning information would help patients better understand the risks, PhRMA didn’t hesitate to voice its opinion. The organization believes shorter or less-complex warnings would help patients understanding the risks and motivate patients and healthcare providers to seek additional information about the drug.

With Phase 2 of Open Payments registration and data submission about to begin and the data publication expected not too far in the distant future, the Sunshine Act is burning brighter than the two suns of Tatooine. Make sure your team understands the nuances of the law The Sunshine Act: The Federal Physician Spend and Disclosure Law from the PharmaCertify™ suite of off-the-shelf eLearning modules.

Well folks that brings us to the end of this episode. Have a great week, and may the Force be with you!

News Week in Review, April 1, 2014

Signs of sunshine in Canada, the DOJ issues its first FCPA advisory opinion of 2014, and the Serious Fraud office faces growing challenges in the enforcement of the UK Bribery Act.

April showers bring May flowers…and we are certainly ready for some flowers! Really, any sign that spring is here to stay would be appreciated. We’re even looking forward to a little spring cleaning as long as the spring part comes along with the cleaning part. So with visions of daffodils dancing in our heads, and the chill of winter fading from our memories, we bring you the compliance news of the week, with the News in Review.

Those May flowers may even have a little Sunshine added to the mix in Canada. Two Canadian physicians think the Ontario Minister of Health should require pharma companies with drugs on public formulary to disclose their financial relationships with physicians. As justification, the physicians claim other transparency initiatives in the country have proven to be both beneficial and popular and studies have shown that even small tokens, such as pens and note pads, influence decision making.

The DOJ’s first FCPA advisory opinion of 2014 has sprouted. The FCPA opinion procedure allows entities to seek an opinion from the Attorney General on whether a specific situation is in line with the DOJ’s current enforcement of the anti-bribery provisions of the law. This particular opinion was in response to a financial services provider and investor bank asking if a payment due to an individual when the individual was a private citizen could be considered illegal if the individual now is a foreign official.

The Serious Fraud Office continues to face stormy weather following the disintegration of the high-profile bribery case against Victor Dahdahel. In addition to the negative publicity around the failed prosecution, the agency has faced significant cuts in funding; increasing pressure to secure convictions under the Bribery Act; and growing questions about how it expects to obtain evidence from jurisdictions outside the U.K.

The seeds of clinical trial transparency are taking root, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA recently provided an update on the adoption of the joint EFPIA-PhRMA principle on clinical trial transparency. According to the announcement, several companies, including Pfizer, UCB and Sanofi, have all taken steps to make the results of their clinical trials publicly available. Pfizer has expanded its policies on data sharing and Sanofi will be participating in a multi-company web portal designed to share clinical trial data. UCB revealed its plans for adoption of the principles in a publicly accessible webinar.

The Ontario College of Physicians and Surgeons is looking to eliminate the need for Sunshine. Proposed guidelines from the influential regulator will put a stop to the practice of physicians accepting gifts or items of value from the industry and will prohibit doctors from having articles ghostwritten by pharmaceutical companies. The guidelines will allow doctors to accept lunches, patient education items, drug samples, and funds for educational programs. Physicians will also be permitted to serve as speakers or consultants. Critics say the proposed guidelines offer nothing in the way of true reform.

Not only does the end of March signal the start of spring, it brings us the deadline for submitting Phase I Sunshine reports. Now that you’ve cleared that hurdle and you have time to stop and smell the roses, have you considered sprucing up your Sunshine training? The Sunshine Act: The Federal Physician Spend Disclosure Law from the PharmaCertify™ suite of compliance training modules, offers the updated training your staff needs to understand the law’s disclosure requirements.

Have a great week everyone!