The 2015 Pharmaceutical Compliance Congress: A Review

The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress, in Washington DC, featured legislators and industry leaders discussing hot topics and best practices to a diverse and rapt audience of compliance professionals.

Annual OIG Update from Mary Riordan

The opening plenary session kicked off with the annual OIG Update, from Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General. In addition to her usual review of recent settlements actions (False Claims and otherwise), and the OIG’s Fiscal Year 2015 Work Plan, Riordan focused on the responsibilities of boards of directors in company compliance functions, and urged the audience to use the OIG’s April 2015 Practical Guidance for Healthcare Governing Boards on Compliance Oversight as a starting point for those expectations. Staying on the topic of board responsibility, she pointed out that prior to her appearance at the conference, Millennium Health LLC had entered into a Corporate Integrity Agreement that requires the company to maintain a majority of independent (non-executive and non-family) directors as part of the settlement.

When stressing that kickback concerns continue in the industry and for her agency, Riordan suggested that attendees “think about the kickback risks associated with financial relationships and strive to identify the relationships that would implicate risks.” What controls are in place? Are those controls meaningful and effective? She emphasized that the OIG was there to help and their goal is “not to collect penalties, rather, it is to encourage companies to comply.”

She also focused on individual accountability and reminded the audience that “individual accountability at all levels of organizations is under fresh scrutiny as the OIG tries to identify individuals responsible for misconduct.”

AUSA Panel

The Assistant US Attorney’s (AUSA) Panel followed with Charlene Keller Fullmer from the US Attorney’s Office in Philadelphia, Jeffrey Steger from the Civil Division of the DOJ, and Kristen Williams from the US Attorney’s Office in Los Angeles, presenting their views on the direction of compliance enforcement. Keller Fullmer said her office continues to see off-label cases focused on kickbacks, particularly with small companies and medical device companies. She pointed out that with smaller companies, pinpointing a paper trail is an easier and less cumbersome process than it is with the larger companies. Following up on Mary Riordan’s comments, she also suggested a review of recent CIAs, and their emphasis on individual accountability.

Williams recited her office’s mantra of “come in, come early, and come often” when discussing how companies should react to an investigation. Demonstrating a robust approach to compliance is critical when she evaluates a compliance program. She recommends a proactive approach, one in which a company responds to issues, before those issues even arise in that company.

For Steger, the key to a successful compliance program is one that involves more than just compliance personnel (a theme throughout the conference). Is compliance part of the company’s culture? Has the company taken proactive steps to initiate and invite feedback, e.g., an 800 number compliance tip line?

FBI’s New Focus on FCPA Investigations

The next plenary presentation was a bit of a twist on the usual agenda, as Jeffrey S. Sallet, National Chief of Public Corruption and Civil Rights for the Federal Bureau of Investigation, offered the update on the Foreign Corrupt Practices Act (FCPA) from the Bureau’s perspective. The focus was on a “five pillars” approach to successful enforcement and according to Agent Sallet, only through a partnership with the public, industry, and other governmental agencies like the SEC, DOJ, and IRS, can the FBI be successful in its goals to encourage a global culture of compliance.

Agent Sallet’s enthusiasm and energy was a tough act to follow and after a break, Thomas Abrams, Director, Division of Drug Marketing, Advertising and Communications, Food and Drug Administration followed up with his annual FDA-Office of Prescription Drug Promotion (OPDP) update. As per usual, Abrams presented a plethora of notes and comments describing the FDA’s efforts over the last year, a high-level review of the document and advertisement submission process and summaries of guidance released and/or updated by his office. These include the 2014 guidance documents on the use of social media.

Abrams closed with a great example of a sales aid that spurred a warning letter from his office. The product being promoted was contraindicated for children under 6 year of age, but the aid included an image of a very young child in its montage of images, and it included no risk information. Seeing such a clear violation provided a concrete and powerful case for why companies need to take the OPDP’s guidance seriously, and regularly test the process for submitting samples through the agency’s email dedicated to that process – ESUB@fda.hhs.gov.

Chief Compliance Officer Roundtable

Following the FDA presentation, a Chief Compliance Officer Roundtable focused on the evolution of compliance programs following the expiration of Corporate Integrity Agreements. CCOs from an array of pharmaceutical companies agreed that while the end of the CIA did not cause drastic changes in their programs, it afforded them the opportunity to expand how they approached topics like training.

One panelist began by stating that on Day 1 following the expiration, there were no public displays and no celebrations, saying “it was business as usual.”

Another panelist recalled that her department was relieved that they could now think beyond four hours of online training and include “short spurts of training throughout the year.” When asked about tracking that training, the panelist admitted that doing so was sometimes a challenge, but the organization was able to “focus on getting back to their true purpose, educating the learners.”

A third panelist brought up the topic of policies and how the shift to a post-CIA environment gave them an opportunity to survey the full staff for thoughts on what works best in compliance polies and subsequently revamp those policies based on that feedback. The company even hired a creative agency to help them create documents that presented policy content in a more graphical and engaging fashion.

The fourth panelist emphasized the importance of developing a risk assessment model and addressing risk-based needs accordingly. Others agreed, emphasizing that they are now using data analytics gathered during the CIA to address those risks.

FCPA Anticorruption Panel

Day 1 closed with a unique twist on the standard presentations, as a panel of in-house and outside attorneys discussed the FCPA through the lens of a hypothetical case. The structure offered a relief from the standard didactic approach to the content, with moderator, Gary Giampetruzzi, Partner at Paul Hastings, guiding panelists through the scenario.

The scenario was structured and branched in a manner that allowed for gray areas and debate as to the best resolution for each question. As an example, when discussing whether post CIA, the Compliance department should be moved back into the Legal department, one panelist avoided what may have seemed the obvious answer of “no,” and stressed that combining the two would be okay if Compliance still had independence despite the structure. An attorney on the panel agreed, especially in terms of the Foreign Corrupt Practices Act, having that independent voice is the key.

US DOJ Civil Section Update

Day 2 started early, with an 8:15 AM update on the DOJ Civil Section from Benjamin Mizer, head of the agency’s civil division. Mizer discussed the growth in qui tam civil cases (FY 2014 saw 469 healthcare-related cases) and presented compelling statistics on the cases involving rewards to relators. In a comment that was prevalent throughout the conference, he reminded the audience of the government’s use of data to expedite investigations and make a decision as to whether or not to proceed.

Update from CMS on Open Payments

The highly-anticipated presentation from Douglas Brown of CMS didn’t disappoint attendees interested in learning details around the data collected and the updates/improvements to the Open Payments system. Brown pointed out that covered recipients with higher counts of payments records were more likely to review and dispute transfers of value, and there were just over 30,000 disputes, equally divided across teaching hospitals, physicians and principal investigators.

On the enhancements front, the agency is focusing on eliminating the character limitations in the system, so email addresses won’t be blocked. The ability to download reported records will also be enhanced to include dispute information and recipients will have the ability to exchange contact information with the reporting entity to further facilitate the review and dispute process.

After providing the audience with a number of reminders, (e.g., device names are now required on submissions, and TOVs to physician-owned distributors are considered indirect payments and must be reported), Brown informed the attendees that the next Open Payments Open Session Webinar is scheduled for Thursday, October 29th.

Qui Tam Panel

The Qui Tam Panel started with Jillian Estes of James Hoyer Newcomer & Smiljanich, PA, reviewing her recent representation of a relator who worked undercover seven years in a pharmaceutical company investigation. Estes used the case to describe who she considered the ideal relator – a principle driven person with a fearless mindset, who is willing to suffer the consequences of a whistle blower. The individual needs to be realistic in expectation and understand that the process is a long one, usually 3-5 years.

Joseph Trautwein, of Joseph Trautwein & Associates LLC, made it clear that the reason potential relators come to him is because they went to their employers first and the situation was not corrected. The panel listed the characteristics of a good whistleblower case:

  • A lie took place
  • A party benefits form the lie
  • The scheme can be easily explained to the government
  • There is enough evidence of misconduct that the complaint will survive a motion to dismiss
  • There is proof of damages
  • It’s a “good story”

Off-Label Communications and the First Amendment

In the final plenary session of the morning, Paul Kalb of Sidley Austin LLP, delved into the Amarin and Pacira lawsuits, whereby the companies presented the argument that criminalizing off-label promotion when it is used to communicate truthful information is unconstitutional. Kalb reviewed the potential ramifications of those cases and closed with the reminder the proverbial jury is still out on how on-going cases will be settled. Based on recent rulings though, we are fast approaching a fork in the road in this core and critical compliance issue.

Mini-Summit: Evaluating Compliance Program Effectiveness

Among the first series of “Mini Summit” breakout sessions, I chose to attend the Evaluating Compliance Program Effectiveness – Board Responsibilities, Board Advisors, and Compliance Experts panel discussion and Q&A.

The first panelist indicated that a good starting point for evaluation of the program is how the company manages high-risk third parties. Are there strong and effective controls in place for third-parties doing business on behalf of the company? Another stressed the need to have outside counsel involved in the program to provide an outsider’s view on the process and the program. A third panelist felt strongly that having people with different backgrounds on the compliance team is important. He also suggested that attendees look at the OIG’s recent guidance for board oversight of the program. “The board needs to demand frequent dialogue,” he said. Another felt that board members have a responsibility to ask questions, review the data, and speak up.

When evaluating training, one panelist emphasized the power of employee surveys to assess whether all participants understood the content of the training. When an audience member asked whether those surveys should be broad or targeted, that panelist said it depends on how each company operates and another added that at his company, they survey the entire employee population.

One panelist also warned the audience about the risk of getting too comfortable in their policies and procedures. New people coming into the company may be coming from a different industry, and may not have had orientation to a compliance program. “Be ahead of the curve,” he said, “when decisions like Amarin come down, you need to be having a conversation.” A fellow speaker followed with the need for an interaction between compliance and the businesses. “It’s important to vet your compliance procedures with the business owners,” he said.

Mini-Summit: Managing Multi-national HCP Meetings

In the Managing Multi-national HCP Meetings: Complying with the Codes and Transparency Requirements session, a panel from around the world discussing the codes and laws relevant to their particular regions.

One industry executive discussed the challenge of holding meetings with physicians from around the world, who each bring their own set of rules from his or her home country. For example, when holding an advisory board with multinational participants, how should meal limits be addressed when those limits vary? The company establishes ground rules but allows common sense to prevail – for example if a limit is slightly above the physician’s home limit, allowing the meals may be a more realistic approach. The executive added that it’s important to create a list of approved meeting places in each country and to train travel agencies on that list.

Hwa-Soo Chung of the Kim & Chang Law Firm in Seoul, South Korea, reviewed the rules in her country, where practices are driven by industry codes with strict limits on speaker meetings no matter where the meeting is held. That severely restricts how much companies around the world can invite Korean doctors to their meetings.

According to Yuet Ming Tham, of Sidley Austin and former Asia-Pacific Compliance Director for Pfizer, “the biggest risks are Korea and China.” The companies she works with will go for lowest meal limit among the group of physicians. In terms of content, companies should always follow the rules of where the meeting is taking place.

Summary

The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress managed to deliver new perspective and debate on the topics facing the life sciences compliance industry, despite what some attendees described as a lack of new guidance, news or government policies in recent months. Each day of the conference was filled wall-to-wall with the type of keynote speeches, panel discussions and networking opportunities both experienced professionals, and newcomers to the field, need to consider as they strive to create and maintain compelling and effective compliance programs.

Thanks for reading,

Sean Murphy

About NXLevel Solutions

Through its PharmaCertify™ division, NXLevel Solutions helps life science companies build positive compliance cultures and reduce risk through innovative training and communication solutions. Our newest tool, TOVdisclosure.com, is a streamlined and intuitive site that enables manufacturers to share payments information with HCPs and HCOs before data is reported to CMS or other authorities. Contact us or visit TOVdisclosure.com for more information.

News in Review, August 11, 2015

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

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

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

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

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

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

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

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

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!

2014 Year in Review

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 Review2014 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, November 26, 2014

Time to head over the river and through the woods to grandmother’s, or somebody’s house, for turkey, gravy, stuffing and pumpkin pie! Thanksgiving is almost here! The Week in Review staff is excitedly looking forward to a day of family, football (Go Eagles!) and tryptophan. Before we start the food prep and festivities though, we need to take care of a little business first; this week’s Compliance News in Review.

Doctors in Michigan aren’t just talking turkey when it comes to the context that surrounds public disclosure of physician payments under Sunshine. A Michigan news outlet gave the physicians that received the most in payments a chance to provide that context. The five doctors received payments in the hundreds of thousands of dollars. For most, the payments represented royalties for devices they had invented. One physician received in excess of $500K for clinical research. The money did not go to the doctor, but to the clinic for which he works, and he is strictly a research physician. Another received almost $350K in payments for consulting and speaking. This physician is a plastic surgeon who runs a training center to teach other physicians. He says consulting pays 1/10th of what he would receive if he were working in his practice, and therefore is not financially beneficial. All of the doctors profiled said they believed physicians should be upfront with patients about their financial relationships with life sciences companies.

A jury in West Virginia found Takeda destroyed documents related to the drug Actos and ordered the company to pay $155,000. The case was brought by an individual who claimed the destruction of the files prevented him from proving his case that the company failed to provide adequate warnings about the cancer risks associated with the drug. A Takeda spokesperson said the company is considering an appeal.

Recoveries from False Claims Act cases are stuffing the federal treasury. The Department of Justice announced that nearly $6 billion was recovered through the False Claims Act in fiscal year 2014. Housing and mortgage fraud represented the largest amount of recoveries at $3.1 billion. Healthcare fraud recoveries were not too far behind at $2.3 billion. Whistleblower cases resulted in nearly $3 billion in recoveries and the government paid out $435 million in whistleblower awards.

The OIG has released a report of the top challenges and issues facing HHS during fiscal year 2014. The report lists several issues related to Medicare, Medicaid and the federal healthcare exchanges. Number ten on the list, ensuring the safety of food, drugs, and medical devices, should be of particular note for the industry. This challenge primarily addresses problems associated with drug compounding and importation of drugs from foreign countries, but the OIG also cites drug marketing; specifically off-label marketing. According to the report, illegal off-label marketing undermines the system intended to ensure that drugs are safe and effective, and may lead to fraudulent claims for reimbursement being submitted to Medicare and Medicaid.

With that final serving of off-label news, we’ve come to the end of this holiday edition of the Compliance News in Review. Have a wonderful Thanksgiving everyone, and remember, it’s all about that baste.

Week in Review, September 30, 2014

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!

Week in Review, August 27, 2014

Another industry organization calls for a change to the Sunshine Act, manufacturers claim data entered into Open Payments is now lost, the Supreme Court is petitioned to review the definition of instrumentality as it pertains to the FCPA, and questions are raised about potential reporting loopholes in the Medicine’s Australia Code of Conduct.

Bananas, fish fingers and custard for all! Doctor Who, season eight, is here! Finally, 12 makes his debut, and we can only hope that he still thinks bow ties and fezzes are cool. And can we just take a moment to thank BBC America for scheduling Doctor Who to run here in the U.S. when it runs on BBC 1? Now we don’t have to spend months trying to avoid news about the show, like we do for Downton Abbey. So let’s jump in the TARDIS and take a journey back in time with this week’s News in Review.

Exterminate! Exterminate! That’s the sentiment of the Council of Medical Specialty Societies (CMSS) regarding CMS’ proposed change to the rule in the Sunshine Act about payments for CME. The Council said the current exemption for payments associated with accredited CME needs to remain in place for several reasons. First, a distinction should be maintained between accredited and certified CME and other educational programs in order to preserve the independence of CME programs. Second, faculty payments should not be subject to reporting because the faculty member’s relationship is with the CME provider, not the manufacturer. Finally, attendees of accredited CME should not be subject to the reporting of payments, because like faculty, attendees have no relationship with the manufacturers providing grants for a program.

Speaking of Sunshine, after Open Payments came back online, drug and device manufacturers reported that payment data once in the system is now gone. CMS says the missing data is due to matching issues. Some of the issues are the result of a data marrying problem that took the system down recently. In other cases, information such as license numbers and names do not exactly match the information in CMS’s database. Policy and Medicine was informed by manufacturers and physicians alike that information that was accurate in Open Payments is now missing. One manufacturer claims all of its clinical research data is now gone. According to the article, the problem could be with the NPPES (National Plan and Provider Enumeration System) database. Portions of New Jersey doctors’ state license numbers were cut off in the database. Also, an analysis last year by the OIG found that almost half of the NPPES records that were inspected contained at least one inaccurate piece of information.

What is instrumentality under the FCPA? We could ask the Inner Council on Gallifrey, but since that is fictional (what!?), the U.S. Supreme Court will have to do. The high court has been petitioned by two individuals convicted of bribery under the FCPA to review a federal appeals court’s definition of an “instrumentality.” The two were convicted of paying kickbacks to employees of a government-owned telecommunications company. The government argued the telecom company was an instrumentality of the government, and the appeals court agreed.

 

Some advocacy groups are already looking for a regeneration of Medicines Australia’s transparency requirements in the latest edition of that group’s Code of Conduct. The Code is pending authorization by the Australian Competition and Consumer Commission (ACCC). The organizations have petitioned the ACCC to not authorize Medicines Australia’s Code of Conduct based on potential loopholes that will allow physicians to opt out of having their payment information publicly disclosed.

 

Well, that bring us to the end of this week’s episode. Based on the plethora of recent news stories related to Open Payments, the demand for transparency when dealing with HCPs isn’t going away anytime soon. The Sunshine Act: The Federal Physician Spend Disclosure Law, from our PharmaCertify™ suite of customizable online compliance modules, offers the content your team needs to stay abreast of the ramifications and reporting requirements of the law. We even offer a complementary Sunshine Act mobile app to help ensure your reps have the information where they need it most – in the field and at their fingertips.

 

Have a great week everyone!

 

Have a great week everyone!