HIPAA

The Right Stuff: Compliance Training in Preparation for Your Company’s First Product Launch

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

A first product launch is an exciting and overwhelming time for any life sciences company. So much to do, and what seems like so little time to do it – especially if you are a compliance department of one or two people. As employees are brought on board in support of the launch, planning and implementing an initial compliance training curriculum is a critical task. You need to cover all the essential bases and topics, and direct the training to the appropriate audiences so individuals aren’t burdened and distracted by messages and information that may not be applicable to their job duties.

With that in mind, the team at PharmaCertify™ has compiled a list of suggested topics and audiences for any company working toward an initial product launch.

Topic 1: Code of Conduct
Audience: All Employees

Good code of conduct training introduces employees and external contractors to the behavioral expectations your company has established. It also provides a foundation for understanding the requirements of working in such a heavily-regulated environment. We could fill an entire blog entry with instructional tips for building effective code training, but for now, we’ll make this one suggestion – make it more meaningful with scenarios that demonstrate how the concepts are manifested in their daily activities. Learners need to relate to the information being presented in order for it to stick.

If your company has not yet developed a code of conduct, see topic two.

Topic 2: Overview of Healthcare Compliance
Audience: All Employees

All employees must be aware of the laws, regulations, and guidance documents related to working for a pharmaceutical or medical device company. If your company doesn’t have a code of conduct, or the code doesn’t include basic information about the laws affecting the industry, a compliance overview course is especially necessary to communicate the concepts they need to know. If you do have a code of conduct, consider the idea of narrowing the audience to the commercial, medical affairs, regulatory, and communications groups.

Topic 3: Interactions with Healthcare Professionals
Audience: Sales, Marketing, Medical Affairs, and Customer-Facing Regulatory

Employees whose job responsibilities involve interacting with healthcare professionals (HCPs) on some level need training to ensure those interactions are in compliance with laws, regulations, and company policy. The training should include topics such as the rules associated with providing gifts and meals; the use of HCP consultants; proper conduct during speaker programs and advisory boards, and interactions at medical congresses or other scientific meetings.

Topic 4: Good Product Promotion
Audience: Sales and Marketing

Sales and marketing teams need detailed training regarding the regulations that govern prescription drug and device promotion. Focus your promotional training on how the regulations affect both verbal and written promotional statements. It should include topics such as what constitutes promotional statements versus medical information; what is a proper promotional statement (i.e., accurate, balanced, and truthful); FDA guidance on dissemination of reprints; and the use of social media.

Topic 5: PDMA and Drug Sample Management
Audience: Field Sales

If samples are going to be a component of the product program, training regarding the requirements of the Prescription Drug Marketing Act (PDMA) is needed before the sales representatives receive any of the samples for distribution. The training should be twofold though and include information about inventory management, and your company’s sample documentation processes – a topic just as important for medical device companies as well.

Topic 6: HIPAA
Audience: Sales, Medical Affairs, and Any Group Interacting with Patients or Handling Patient Information

The protection of patients’ personal information is a hot button issue, so you need to ensure those who handle, or who may be exposed to that information, are aware of their responsibilities regarding confidentiality. In addition, credentialing requirements at hospitals and other facilities now require anyone doing business in those facilities to be trained on the requirements of HIPAA and the protection of personal health information. In fact, if your sales representatives are going to be selling in a hospital environment, you will want to add Bloodborne Pathogens and Aseptic Technique training to their curriculum as well, but we will save that for our blog entry on the rise of credentialing and its requirements.

More Information

While the above list of topics constitutes a strong compliance training foundation for any company moving toward its first product launch, the topics and audiences may need to be tweaked based on your particular product and product indication.

The PharmaCertify™ team of compliance subject matter experts and instructional designers are here to help and we are making information available to you. To see an expanded list of the suggested content for each of the topics listed above, contact Sean Murphy, Product and Marking Manager at smurphy@nxlevelsolutions.com, or 609-483-6876.

Thanks for reading and stay compliant!

Lauren Barnett, Compliance Content Specialist, PharmaCertify™ by NXLevel Solutions

Compliance News in Review, July 5, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

Buy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for You?

NXLevel Compliance Team , , , , , , , , , , , , , , , , , ,

During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom for online training,” and “off-the-shelf just doesn’t meet my content needs.” She went on to explain that with custom-developed training, she could target specific topics and include company-specific policies in a way that she never could with off-the-shelf.

Fair point, but she failed to take into consideration that while custom-developed training can indeed be built to focus on the compliance content she needs to cover, well-built, flexible off-the-shelf training provides a solid foundation of knowledge, which can then be supplemented with targeted, custom micro-learning in the future, as gaps and custom needs demand.

Start with Off-the-Shelf

Small to mid-size pharmaceutical and medical device companies need effective training covering core topics such as off-label promotion, transparency, gifts and meals, and adverse events, but the training resources and budgets available to many compliance departments, which often consist of a staff of one or two, are quite limited. Instructionally sound, industry-focused, off-the-shelf training can easily and quickly provide core compliance training, without draining your limited resources and time.

For obvious reasons, off-the-shelf, even when tailored to include your specific policies and contact information, can be deployed more quickly than a fully custom training course. Review times are shortened and less demanding, and when a need for training on a specific topic (e.g., speaker presentations) is identified, off-the-shelf gives you the flexibility to deploy rapidly while the topic is still top of mind to your learners. Moreover, with quality off-the-shelf training, content is developed by someone with specific knowledge of the industry, and expertise in commercial compliance. Therefore, your time isn’t consumed with being the primary subject matter expert.

A Time and Place for Custom

This is a need for custom online learning in an effective compliance training curriculum – one that addresses all of your organizational risks and truly helps to build a positive compliance culture. The most recent research points to the importance of spacing learning over time and providing review and reinforcement exercises after the initial training is launched to improve retention. As educational psychologist Steven Just, Ed.D., founder and former CEO of the assessment company, Pedagogue, writes, “To learn, you must cognitively act upon the learning materials, and to retain what you have learned, you must actively re-engage with the learning repeatedly over a period of time.” Starting with off-the-shelf, then mixing in smaller, more cost effective, custom mini modules and interactivities (video scenarios, games, assessments) over time and across a well thought out compliance training plan, has been proven to support on-going behavior change – a key objective in the world of commercial compliance.

Summary

While custom online compliance training should certainly play a role in the on-going execution of your compliance training plan, launching a foundation of targeted, off-the-shelf courses to address important topics to a broad audience represents a rational and cost-effective starting point for any life sciences company’s compliance training curriculum.

Don’t forget to “follow” the PharmaCertify™ blog by clicking the blue link on the right so you don’t miss our updates. Coming soon, The Right Stuff: What Compliance Topics to Cover in Your Product Launch Training.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager PharmaCertify by NXLevel Solutions

News in Review, June 15, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , ,

Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

CBI’s 13th Annual Pharmaceutical Compliance Congress, held last week at the Ritz-Carlton in Washington DC, offered an impressive lineup of industry luminaries and government regulators discussing a wide range of compliance-related topics. While some of the discussions didn’t offer much in the way of groundbreaking information (tone at the top, embed compliance in the businesses, relationships matter, etc.), the concepts presented were critical for any attendees new to their role or the world of life sciences compliance in general.

Embed Compliance into Business Practices

There was the expected emphasis on the concepts of embedding compliance into business practices and gaining buy-in from the C-suite. One panelist even mentioned that when asked to join her current company, she insisted that she be a member of the North American leadership team and therefore have direct access to the business leaders. As another speaker put it, “relationships matter, and you have to speak the language of the businesses in their terms.”

Tie Compliance to Incentives

One compliance officer from a small pharmaceutical company referenced the need to make sure sales incentive is tied to compliance, to make the concepts and policies more meaningful – a concept that was considered revolutionary in the industry just a few years ago. She added that sales management needs to own the compliance metrics in order for there to be lasting and real change. The same global officer touched on the challenges of doing business globally and the need to have tough conversations about spending caps. “You will get pushback,” she stressed, “but don’t compromise. There’s no need to take that kind of risk.”

Transparency: Think Globally, Act Locally

Continuing on the global front, presenters reviewed the merits and details of global transparency codes like EFPIA, while touching on upcoming movements toward laws and guidance. When dealing with global regulations and codes, the potential for confusion reigns. For example, when providing meals to HCPs from various countries, one panelist advised audience members to use the lowest common denominator for the meal limit, BUT, don’t forget to take Loi Bertrand into consideration if an HCP happens to be from France.

In addition, panelists stressed that companies can’t fall into the trap of thinking that because they are familiar with the rules around the Sunshine Act and Open Payments, they can roll right into global reporting. As one speaker from a large pharmaceutical company suggested, you have to look at it differently. “If you approach it like you approach Open Payments, your credibility will be challenged.”

Yates Memo and Individual Culpability

Among the regulators and defense attorneys who spoke during the conference, one common theme was the Yates Memo, and the affect it has (or is some cases, doesn’t have) on how investigations are conducted and cases prosecuted. The Memo, which is named for Department of Justice Deputy Sally Quillian Yates, was released in September of 2015. It generally states that the DOJ will increasingly target individuals in corporate crimes. A number of the regulators stressed that while the Memo is significant in its scope, it will not necessarily change how their offices pursue pharmaceutical and medical device cases. During the U.S. Healthcare Fraud Enforcement Panel, one US Attorney said it “codifies what they have already been doing in her office” and another commented that he asks his prosecutors to always look at individual culpability in each case.

Innovations in Training

As a compliance-focused learning company, we at PharmaCertify™ pay close attention to presentations and commentary with a slant toward training. It’s been a slow process, but based on the information and concepts presented in this and other recent conferences, it’s clear to us that companies are integrating exciting and novel techniques into their curriculums. Innovative compliance departments are adding micro-learning solutions and app-based tools in an effort to raise the level of engagement among their learners, which is music to our ears.

One company representative detailed the planning process and upfront analysis she and her colleagues conduct to ensure that training concepts meet the needs of the business as well as the compliance department. Once those needs are identified, they look for unique ways, including a healthy dose of humor, to make their messages stick. She and her co-presenter reviewed the details of the compliance app recently launched across the company, which uses self-produced video sequences, with compliance department employees as actors, to communicate the concepts. While we agree that technique can help to “humanize” compliance, as we warned in a recent post, you need to be careful that bad acting doesn’t distract from the important messages.

While this year’s Pharmaceutical Compliance Congress featured much of the same themes as recent conferences, the ever-evolving world of life sciences compliance always offers new twists and turns for those tasked with ensuring their individual companies remain in alignment with the latest rules and regulations. These conferences offer attendees the invaluable opportunity to learn best practices, tips, and updates directly from their peers and government regulators from around the world. They shouldn’t be missed.

See you at the next conference!

Compliance Edutrainment: Too Much of a Good Thing?

NXLevel Compliance Team , , , , , , , , , , , , , , , ,

These days, the standard airline safety presentation is delivered via video on most aircraft. Somewhere along the way, airlines decided this approach was an opportunity to express their creative spirit, and a bit of a competition developed, with the imagined spoils going to the company that produces the most entertaining safety video. That competition reached a new level when Virgin America rolled out its Safety Dance video. It boasts talented singers and dancers (and one Olympian) delivering the FAA- required safety information. If the objective is simply to entertain, then mission accomplished. However, if the objective is to educate passengers about safety protocol, we’re not sure it hits the mark.

The world of compliance training has thankfully evolved beyond the “death by PowerPoint” approach that dominated the life sciences landscape years ago. Those charged with developing compliance training now look to create programs that are more engaging and entertaining. In the case of eLearning, a number of tools and techniques can be applied to deepen engagement and learning, but if overused, or misused, the same tools have the opposite effect and distract from the learning. We call this the Edutrainment Trap.

All good adult learning starts with objectives, answering the question, “What do I want the learner to know and be able to do by the end of this training?” Enamored with the latest tools and ideas, losing sight of objectives once we start to design and develop the learning is easy. Here are five tips to help keep your compliance organization from falling into the Edutrainment Trap:

  1. Use Interactivity Intelligently: The interactivity itself is often overused in online compliance training. Of course, a well thought-out level of interactivity is important, but overloading the interaction on every screen only serves to distract the learner from the salient points. When covering critical topics like off-label marketing and privacy, interactive exercises and games need to be integrated intelligently, and in a manner that doesn’t cloud the learning with unnecessary messages. Interactive elements should serve a purpose, and not just be included for the sake of entertainment.
  2. Include Targeted Imagery: Images and graphics are sometimes misused or overused in a way that distracts from the core objectives. There is truth to the phrase, “a picture is worth a thousand words” and well-placed imagery is certainly more engaging than an overabundance of text on screen. But when the objective is to ensure the learner can “demonstrate an understanding of the payments that need to be reported under the Sunshine Act,” pretty pictures only go so far. Relevant images and graphics that reinforce key concepts and support learning objectives are needed.
  3. Mind the Bandwidth: Video and animation offer exciting opportunities for compliance training, but like any new tools, they need to be utilized judiciously and with the objectives in mind. In this time of high-speed corporate networks, we can forget that bandwidth is sometimes an issue for third-party vendors. An overabundance of video or complex animations may cause problems. Think carefully about geography and access when developing that global transparency module for deployment around the world.
  4. Remember that Acting Counts: If live actors are being used, make sure the subject matter remains the star of the training. Oscar-quality acting isn’t necessary for the training to be effective, but there is a fine line between amusing amateur acting and just plain bad acting. When the goal is to communicate the seriousness of a topic like the Anti-kickback Statute and its implications, amateur acting will derail any hope for effectiveness, as the learners start to pay more attention to the acting, and not the learning. Similarly, the more conversational the dialogue, the better. If the narration sounds like someone is reading a law journal or compliance policy, learners will tune out.
  5. Be Mindful of Cultural Differences: Making cultural references or using humor can be a fun way to interject life into training, but it has to be included carefully. Jokes can lessen the importance of the message. Cultural references that the audience may not understand can frustrate and ultimately distract the learner, leaving them saying “huh?” instead of “I got it.” This safety video by Delta is a great example. The video is entertaining, funny, and clearly communicates the required safety information – all good things. However, if the learners are not familiar with the nature of viral videos and Internet stars, the humor is lost, and the random assortment of characters only leads to confusion.

Avoid the Edutrainment Trap of loading training with every bell and whistle imaginable in the effort to make the learning fun and engaging. A good balance of imagery, text, and interactivity keeps training interesting and flowing and is a necessity in today’s complex regulatory landscape. Understanding which techniques are most effective and appropriate for the learners and the subject matter is the key to developing effective and highly-engaging training.

Thanks for reading and stay compliant!

The 2016 Pharmaceutical Compliance Congress: a Preview

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

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, March 8, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , ,

A bill is introduced in the Senate to end DTC advertising, Endo settles with New York over alleged marketing violations, and Olympus settles multiple False Claims Act, Anti0kickback, and FCPA charges.

March has certainly roared in like a lion, but will it go out like a lamb? Or will it go out more like a Blue Devil, a Jayhawk, a Cardinal, or a Wolverine? March Madness is almost here, so rise up bracketologists! Whether you employ a highly-scientific method for filling out your brackets, or you make your picks based on which team colors, it’s time to put pen to paper (or fingers to keyboard) and make you selections official. Before you get completely engrossed in what sixteen seed might have a shot at the huge upset in the first round, let’s take a look at what has dribbled through the newswires lately, as we tip off on this edition of the Compliance News in Review.

Senator Al Franken is the latest to join the “Ban DTC Advertising” team. The Senator has introduced a bill that would end the DTC advertising tax break for drug companies. Franken argues the costs of the ads are increasing the costs of drugs, and they encourage consumers to seek new, expensive medications, over cheaper alternatives. A spokesperson for PhRMA said the legislation “ignores the value of information patients about their health care and treatment options,” and it may have the unintended consequence of a patient not seeking medical attention for chronic conditions that can be managed more cost effectively when treatment begins early.

Endo has resolved a marketing foul with the state of New York. The company reached a settlement with the State over its marketing of an opioid pain medication. According to the state’s Attorney General, Endo claimed its painkiller, Opana ER, was crush resistant and it underplayed the addictive nature of the drug. The AG said the misleading marketing led to increased sales of the drug because it created a “false sense of security.” The company agreed to pay $200,000 and to cease marketing the drug as crush resistant. Additionally, Endo must create a program to keep its sales team from promoting the drug to healthcare providers who may be prescribing it in an abusive manner.

Olympus Corporation of the Americas (OCA), has agreed to pay $646 million to settle criminal and civil charges related to violations of the False Claims Act, the federal Anti-kickback Statue and the FCPA. The endoscope maker was accused of paying kickbacks in the form of consulting payments; free endoscopes; travel; meals; and grants. The company will pay $312 million to settle charges of paying kickbacks and $310 million to resolve the False Claims Act charges. The company’s Latin American subsidiary is accused of making payments to healthcare providers working in government-owned hospitals in Central and South America in order to secure business. The company will pay $22.4 million to resolve charges it violated the FCPA and it has entered into a three year Deferred Prosecution Agreement (DPA) and a Corporate Integrity Agreement (CIA). The DPA requires the establishment of a confidential hotline, improvements to the compliance training and the establishment of a program to recoup executive performance pay for those who participate in misconduct or fail to promote compliance. The CIA requirements include the implementation of a healthcare code of conduct; specific training and education; and requirements around grants and charitable contributions, consulting arrangements, and travel expenses.

The DOJ noted in its press release about the Olympus settlement that “the criminal complaint alleges that the improper payments happened while Olympus lacked training and compliance programs.” A “subpar compliance program,” was also noted by prosecutors in the recent SciClone FCPA case and the Sweett Group UK Bribery Act case. Regular and effective training is a key element of any effective compliance program, and helps reduce the risk of violations. While laws such as the False Claims Act of the FCPA may not change often, training on these laws cannot be conducted in a “one and done” manner. It should be reviewed and refreshed regularly, and highlight real-world examples applicable to the industry to keep it relevant and fresh.

With that, the buzzer has sounded on this edition of the Compliance News in Review. If you have a rooting interest, good luck to your team(s) in the upcoming tournament.

Stay compliant and we’ll see you right back here for the next edition

Compliance News in Review, February 23, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

Did you feel the awakening? It was as if a million voices cried out in joy, then were suddenly, silently going about their business again. Geekerati rejoice! The Star Wars: Episode VII video announcing the beginning of production on the next installment has been released. December 15, 2017 can’t get here fast enough! We’ll have to wait to learn about what happens in that galaxy far, far away, but in the meantime, we can at least keep up with the recent news from the compliance universe, with this edition of the Compliance News in Review.

Do you have questions about this year’s Open Payments submission? There’s no need to seek answers using the Force while CMS is around. The agency held a webinar to discuss this year’s submission and take questions from stakeholders. CMS presented an overview of enhancements to the system and the timeline for submissions before taking questions. Those questions focused on reporting requirements, the dispute process, and the deletion of records.

UK government officials are launching an “urgent investigation” (hopefully not urgent enough to break out the mind probe) into the possibility that National Health Service (NHS) officials received consulting payments from pharmaceutical companies. The investigation is based on a report by the Telegraph that more than 130 NHS officials, most in positions to assess what medications would be used by patients, were receiving the payments. The payments were allegedly provided to the NHS workers in return for serving on advisory boards. Activities related to the advisory boards ranged from participation in teleconferences to travel to meetings outside the UK, where the participants stayed at luxury hotels.

Negotiations in the Amarin case are moving slower than a space slug. The FDA and Amarin have requested a third extension in the process as they look to reach a settlement in the case involving the off-label promotion of Amarin’s omega-3 drug. The extension will delay the court proceedings until March 18.

Pfizer has reached an agreement in principle with the federal government in a False Claims Act case involving the calculation of Medicaid rebates for the drug Protonix. The product was marketed by Pfizer’s Wyeth unit. The company will pay $784.6 million to resolve the charges, and will not admit any liability in the case.

The Jedi Master of the Serious Fraud Office (SFO) will remain in his post a bit longer than planned. The UK’s Attorney General extended the contract of SFO head, David Green, for two years. Green’s contract was set to expire in April, and now will expire in April of 2018.

France could be joining the Alliance of countries beefing up their anti-corruption laws. Draft legislation of an anti-corruption law will be presented to the French State Council for validation, and will then move on to the legislative process. The French Parliament is expected to begin its review in April of this year. Highlights of the draft include the creation of anti-corruption agency with the power to impose sanctions; a requirement mandating corporations have a compliance function in place; and the implementation of a number of Sunshine requirements, most notably the disclosure of payments to lobbyists.

Anticorruption efforts by government agencies have certainly been a hot topic of late. From the announcement that the FBI would be hiring additional FCPA investigatory staff, to the SciClone settlement, and the news of a new law on the horizon in France, governments around the world are taking steps to root out bribery and corruption. That’s why now is as good a time as any to review your company’s current anticorruption program, including the training that addresses anticorruption laws. For multinational companies, training on the FCPA alone is not enough. The UK Bribery Act is just as far reaching, and your colleagues need to understand the differences in the two laws. In addition, both Mexico and Brazil have implemented tougher anticorruption laws in the last several years, and training should be provided on those as well.

Thanks for reading everyone, and may the Force be with your compliance training efforts.