A Look Ahead: The 2018 Pharmaceutical and Medical Device Compliance Congress!

Look for the “elephant in the Exhibit Hall” at the Pharmaceutical and Medical Device Compliance Congress to see demos of our compliance training solutions!

If you haven’t yet registered for the 19th Annual Pharmaceutical and Medical Device Compliance Congress, there is still time to save $600 on the registration fee with our sponsor discount offer. Contact me at smurphy@nxlevelsolutions.com to ask about the details.

The conference kicks off Wednesday, November 7th at the Mandarin Oriental Hotel in Washington DC, and NXLevel’s PharmaCertify team will be there to catch up with friends and clients and showcase our newest compliance training products. If you’re attending, stop by Booth 108 in the Exhibit Hall (you can’t miss us, we’re right next to the food table and by the bar) to say hello and register for a chance to win an Echo Smart Speaker with Alexa!

You will also see us listening attentively throughout the panel sessions and presentations for the latest compliance best practices and suggestions from what is always an impressive list of industry professionals and government representatives. In addition to the keynotes and plenary sessions, PCF has packed the agenda with 27 different mini summits attendees can choose to attend. With that in my mind, we’ve once again scoured the agenda and highlighted a few of the presentations we’re looking forward to in particular.

Day 1: Wednesday, November 7, 2018

Preconference 1: Patient Support Programs: Risk and Risk Management Best Practices

Right out of the gate, PCF is offering attendees the choice of four compelling preconference sessions from 8:00 AM to 12:00 Noon. This Patient Support Programs session is offered as a “deep dive workshop” with timely talking points that include the most common manifestations or structures of Patient Support Programs (PAPs) and the best practices and approvals of the activities. A quick scan of recent corporate integrity agreements highlights the enforcement focus on PAPs, and kudos to PCF for wasting no time addressing it, with a panel that includes Nereyda Garcia from Alnylam Pharmaceuticals, and Nicole Serena from Bayer.

Keynote: OIG Update

Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General for Office of Inspector General, returns for this highly-anticipated review of recent settlement actions and the OIG’s workplan for the upcoming year. From year to year, the presentation is considered one of the cornerstones of the conference as Ms. Riordan discusses the areas currently on the enforcement radar for her office.

Chief Compliance Officer Roundtable

The conference agenda doesn’t provide any details in terms of what topics the CCOs will cover but based on the level of panelist expertise and the fact that it’s scheduled for one hour and fifteen minutes, the roundtable is sure to provide a bevy of useable, first-hand lessons and advice. Panelists include Jill Fallows-Macaluso from Novo Nordisk, Indrani Lall Franchini from Alexion, Jonathan Kellerman of Allergan, Puja Leekha of Lundbeck, and Lori Queisser of Teva.

Networking Reception

The networking reception is a rare, can’t miss opportunity to meet with your peers face-to-face and exchange tips and ideas for strengthening and growing your compliance program. And don’t forget to visit the vendors while you’re in there. They bring a range of innovation and expertise to the industry… and you don’t want to miss those cool giveaways!

Day 2: Thursday, November 8, 2018

During the first half of Day 2, we hear from the government regulators, investigators, and prosecutors with three different sessions: the Assistant US Attorney Roundtable, FCPA Enforcement Update, and the Qui Tam Roundtable.

FCPA Enforcement Update

In light of the recent FCPA case settlement by Stryker, this session should provide interesting insight into the enforcement trend surrounding the Act. Will more cases surface? Is there a renewed focus on the life sciences industry? With panelists from the FBO, the DOJ, and formerly with the SEC, the conversation should prove to be enlightening and educational.

Mini Summit 1: Fostering a Culture of Ethics and Compliance Beyond Just the Laws and Regulations

The first of seven 11:00 AM mini summits, this session captured my attention for its interesting title. The debate over a rules-based approach to compliance versus a values-based approach is not new to the life sciences industry. I will be curious to hear, particularly from a training perspective, how this panel fosters a culture that emphasizes empowerment to always “make the right decision” while still communicating the need to follow the rules and the laws.

Mini Summit IV: Annual Medical Device Compliance Roundtable

This dedicated medical device session features Jonathan Glazier from Philips North America, Marc Levine of Insightec, Laura O’Donnell from GE Healthcare, and David Ryan of Epizyme discussing the topics unique to the industry. The medical device industry faces some of the same compliance issues as their pharmaceutical brethren, but the nature of the products and business process (e.g., reimbursement) present unique challenges. I am anxious to hear how these presenters address risk and strengthen their compliance cultures while facing those challenges.

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace.

That title to this session is a mouthful, but it invokes a promise of a forward-thinking approach to the content. Expect this impressive panel, which includes Terra Buckley of Celgene, Michael Clark of Indivior, and Sujata Dayal of Johnson & Johnson to offer bold suggestions beyond the current thinking for the pressing topics listed in the title.

Mini Summit X: Is Your Board of Directors Bored of Your Compliance Dashboards?

Okay, I admit it, the sessions with the creative names tend to catch and pique my interest. Thinking beyond the clever title though, this afternoon mini summit tackles the tricky subject of the board’s involvement and support of the company’s compliance program. It’s a topic that’s been of focus for regulators

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing   

Since employees who interact with healthcare professionals face a high level of compliance risk, I will be interested to hear how the panelists, including Pamela Lonzer from Alexion, Margaret Sparks from Sanofi, and Ravi Taylor of Ferring, balance the business need for representatives and others to engage with those HCPs, while instituting safeguards to ensure compliance with company policies and regulations.

Mini Summit XXVII: The Compliance Training Revolution

PharmaCertify had the opportunity to sponsor the 3rd Annual Life Science Compliance Training Conference back in June (you can read our key takeaways here), and I came away from that conference pleased that the industry is clearly developing more innovative training with the intent to optimize the learning and create lasting results. It’s been our focus since we started developing compliance training 12 years ago, and I look forward to hearing more about the techniques the panelists utilize to accomplish that same goal.

Summary

Again, these are just a few of the many sessions PCF is offering at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. We look forward to seeing you there and as always, I welcome your feedback on this preview and our blog in general. If you’re attending the conference, don’t forget to stop by the PharmaCertify booth (#108 in the Exhibit Hall) to say hello.

Thanks for reading and we’ll see you in Washington!

9th Annual Life Sciences West Coast Compliance Congress: A Preview

CBI’s 9th Annual Life Sciences West Coast Compliance Congress is less than three weeks away and we’re looking forward to yet another opportunity to catch up with colleagues and clients and showcase our newest life science compliance training products. The conference gives those of us located on the other side of the country an opportunity to hear tips and best practices from industry professionals who don’t normally participate in the East Coast conferences. A quick scan of the agenda reveals company names as diverse as. Here’s a brief preview of the sessions and panel presentations scheduled for the two-day conference.

Day 1: Wednesday, October 17th 

Chief Compliance Officer Keynote Panel

After two pre-conference summits, one covering aggregate spend and the other patient support programs, the conference sets the stage with a panel of former and current chief compliance officers, moderated by John Kelly of Bass Berry & Sims, and formerly of the Department of Justice. As someone who attends a significant amount of conferences, I support this idea of diving right into the topics at hand, rather than leading off with a speaker who may bring some name recognition or star power but doesn’t necessarily speak to the primary concerns of the audience.

Enforcement Panel: Fraud and Enforcement Trends – Current and Former Perspectives

The enforcement panel scheduled for 2:15 is an interesting blend of those currently in an enforcement role (Chinhayi Coleman Cadet from the Northern District of California and Rachael Honig from New Jersey) with those who formerly served in an enforcement role and now work in the private sector (the aforementioned John Kelly of Bass Berry & Sims and Robert Marasco from Dinsmore & Shohl LLP and former AUSA from New Jersey and the Southern District of California).  The duel perspectives should provide compelling insight into the current prosecutorial trends in the life sciences industry.

Roundtable Discussion: Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)

After a networking and refreshment break, the conversation turns to the timely topic of GDPR. Clearly, there are questions and confusion around the regulation, and we’re especially hoping to hear how these panelists build and deploy training on the hot topic of GDPR. Who are they training in the organization? What topics under the GDPR umbrella are they covering? How often are they updating that training?

Immediately following the GDPR session, Day One closes with a networking, wine, and cheese reception. As you chat with your colleagues and network with new associates, we invite you to stop by the PharmaCertify Booth to learn more about our training solutions. While there, don’t forget to enter the drawing to win an Amazon Echo Smart Speaker with Alexa!

Day 2: Thursday, October 18th

Interactive Exchange: Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned

Following two sessions on monitoring and auditing, the focus turns, not surprisingly, to yet another hot topic currently under the regulatory microscope, speaker programs. This session should prove to be even more enlightening and revelatory since it is billed as an “interactive exchange” with panelists listed as “conversation contributors.” Those contributors, Ishita Arora of Horizon Pharmaceuticals, Danielle Davis of Insys Therapeutics, Eric Jen of Horizon Therapeutics, and Jenny Shire of Daiichi Sankyo, are sure to have the full attention of an audience hungry for suggestions on how to manage risk in planning and executing the programs.

Choose Between Two Master Classes (A-B)

Before a networking lunch break, attendees have the option to choose between two “master classes” focused on topics that continue to be a source of risk.

Master Class A: Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication

During CBI’s Compliance Congress earlier this year, we learned that the regulatory focus on off-label promotion has shifted somewhat from larger companies to emerging companies and start-ups. Off-label concerns continue to be at the top of qui tam cases, and we’ll be curious to hear the steps Sharon Delshad of Nalpropion Pharmaceuticals and Gary Messplay from King & Spalding recommend for reducing off-label risk

Master Class B: Navigate Third-Party Relationships and Outsourcing Arrangements

For companies that utilize third-party entities for global transactions, Richard J. Ciamacca of Amring Pharmaceuticals, which positions itself as a company that “sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients,” will offer his insights on navigating the potential risks of those relationships.

Calibrate to Your Organization’s Size – Compliance Program Benchmarking Based on Company Resources

Anytime I see “benchmarking” in the title for a session, I am intrigued. It’s one of the reasons attendees are so interested in attending conferences like these, they want to benchmark their activities and programs against others in the industry. This hour-long session is divided into three presentations: How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy with Sharon Delshad of Nalpropion; Managed Markets Compliance – Mitigate Risks in Relationships with Payers; and Collaborate with Medical Affairs and Elevate MSL Oversight with Tim Ayers from Life Science Compliance Consulting LLC and Gregory S. Moss from Kadmon.

Summary

CBI has a well-earned reputation for organizing compliance conferences that bring together an impressive array of professionals and government representatives to share tips, best practices, and lessons learned. The 9th Annual Life Sciences West Coast Compliance Congress is no exception.

As a proud sponsor of the 9th Annual Life Sciences West Coast Compliance Congress, we can offer you a $500 discount on the regular registration price. It’s not too late to register at this special rate, but the discount certificates are limited. Contact me at smurphy@nxlevelsolutions.com if you are considering attending. If you’re already registered, we look forward to seeing you in San Francisco!

Thanks for reading!

Sean Murphy
Marketing Manager and Compliance Training Insights Blog Editor
PharmaCertify by NXLevel Solutions

10 Tips for Creating Transparency Training That Sticks

With government investigators rigorously examining Open Payments, and on the hunt for red flags, the need for effective tracking and reporting training is more important than ever. Here are ten tips to help you build and deploy transparency training that reduces risk across your organization. 

  1. Go global.
    Make sure your employees understand that transparency covers multiple countries, not just the U.S. Global companies need to think beyond the Sunshine Act and include the relevant codes and laws from around the world. Don’t forget to incorporate requirements from codes like the EFPIA Disclosure Code and the Medicines Australia Code of Conduct, and regulations like Loi Bertrand (French Sunshine Act).
  2. Keep the reports formal.
    Stress the importance of using legal names of healthcare professionals for reporting purposes. Even if an HCP is commonly known as Bob, his license probably reads as Robert. Only legal names should be used. Warn the learners about facility names as well. For example, Saint Joseph’s Hospital for Children might be commonly known as Saint Joe’s, but the full name needs to be used in the reports.
  3. Add in reference resources.
    When developing training, include resources for learners to use on an on-going basis. Infographics or quick reference materials are good options for learners to self-check information they may have forgotten after they completed the training.
  4. Emphasize that ALL HCP spend needs to be tracked.
    Spend reporting requirements vary from jurisdiction to jurisdiction. A cup of coffee may or may not be reportable, depending on the circumstances. Learners should understand that accuracy is important for HCP spend, regardless of amount or spend type.
  5. Don’t forget the T&E process.
    The details of the travel and expense system are critical. Make sure learners know how to properly record HCP spend in your company’s system. For example, some systems (e.g., Concur) differentiate between a “business guest” and an “HCP guest.” Attributing the spending to the correct category in the system is a time-saving step that helps ensure accurate data.
  6. Include examples of data entry errors.
    Some data entry errors are common, and so are the instructions for correcting them. Identify the common errors in your system and highlight them in the training so learners recognize them during the actual data entry process.
  7. Include a section on HCP interactions.
    Healthcare professionals are aware of the buzz around transparency and privacy. They’re bound to have questions. Instruct sales representatives on how to answer their questions and address their concerns.
  8. Review the rules on speaker programs.
    HCP consultants who serve as speakers on behalf of the company need to make the audience aware that they are being paid by the company. Also, sign-in sheets are necessary to accurately record attendance and account for every physician in attendance.
  9. Make it easy to report errors.
    Include information about the process learners should use, including contact information, when they find errors (misspellings, incorrect state license number, incorrect address, etc.) in the training. Make that information available as a resource they can use later.
  10. It’s all about accuracy.
    No matter the format (live, eLearning, WebEx, etc.), make sure the need for accurate reporting is a recurring theme throughout the training. Take the time to identify and fully understand where errors typically occur in the process and build that information into the follow up training in the form of scenarios and stories. Long live accuracy…king of the content.

The Compliance Foundations™ customizable eLearning module, Global Transparency: Reporting HCP and HCO Transfers of Value, helps learners understand the requirements of worldwide transparency laws and codes, and how those rules help foster open relationships with a company’s HCP customers. Contact me at smurphy@nxlevelsolutions.com if you’d like to see a content outline or course demo.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Insights Blog

A Medical Device Issue of Dear Connie, the Compliance Training Specialist!

Welcome to “Dear Connie, the Compliance Training Specialist,” where we answer questions about a panoply of compliance training topics and present solutions for strengthening your compliance culture and reducing risk.

This week: Clearing the Confusion of Medical Device Codes

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Dear Connie,

I am a new compliance training manager for a growth-oriented medical device company near Boston, Massachusetts. I always look forward to your tips on training for the life sciences compliance industry in general, but in this case, my question is specific to the medical device space.

My company is growing rapidly overseas and I don’t have a good handle on the details of all the codes that govern our industry. I have created my own spreadsheet with what I think I need to know for each, but I sure would welcome a more official resource for comparison. As I start the process of analyzing my curriculum, how do I know I am targeting the right employees and third-party vendors with the right code training?

Can you help me sleep better, Connie?

Quizzical in Quincy

Dear Quizzical,

I feel your pain and your sleeplessness. The proliferation of medical device codes around the world can be confusing for those of us trying to manage risk. In addition to the AdvaMed Code, you need to be aware of the AdvaMed Code of Ethics on Interactions with Health Care Professionals in China, the MedTech Europe Code of Ethical Business Practice, and the APCMed Code of Ethical Conduct for Interactions with Health Care Professionals…whew that’s a mouthful and a training plateful.

Fortunately, AdvaMed has published a chart comparing the purpose and scope of each one, as well as topics like healthcare professional training requirements, provisions on payments of royalties, sales and promotional meetings, entertainment and recreation, support of third-party educational conferences, and more. I suggest you download the chart from the Resource Center page on the AdvaMed website and read it carefully – there is a plethora of helpful information there.

By the way, since you mentioned that you’ve started an analysis of your curriculum, I also recommend the article published by my friends at PharmaCertify for the industry publication, Life Science Compliance Update. It’s called Improving Outcomes: Analyzing a Compliance Training Curriculum to Reduce Risk and the reprint is available for download on their website.

Thanks for the great question. I always enjoy hearing from my friends in the medical device world.

Good luck and good training!

Connie

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

CBI’s annual Pharmaceutical Compliance Congress, which took place April 23rd to the 25th in Washington DC, featured industry leaders and government representatives espousing the usual best practices for building and maintaining an effective compliance program, but this year’s agenda offered a few surprises and changes in the regulatory wind. The notes below highlight some of the sessions we found to be particularly interesting and newsworthy.

Day 1

CCO Exchange – Adapting and Evolving Compliance Programs in Support of Innovation

Following the opening remarks and a session covering politics and the pharmaceutical industry, the conference kicked into gear as Maggie Feltz of Purdue Pharma, Jennifer McGee of Otsuka, Jill Fallows Macaluso of Novo Nordisk, and Sujata Dayal of Johnson & Johnson discussed their process for “partnering with business” in the company to maximize the strength of their compliance programs. The panelists stressed the importance of establishing a relationship with business that is built on open dialogue and trust.  Documentation is also key to that relationship and as one panelist pointed out, “the government cares about how you document that you are preventing issues.” It’s important to “shape the way you are perceived in the relationship by using business language,” she emphasized, and to measure your own effectiveness by simply determining whether business is inviting you back to the table. Your compliance program is only effective if you have a seat at that table.

Once the partnership is established, you need to “get the business to think and talk about risk and conduct a benefit-risk analysis,” according to one panelist. Another reminded the audience that Corporate Integrity Agreements (CIAs) hold important clues about topics of focus for the government. This is particularly enlightening considering the recent Aegerion and United Therapeutics CIAs that dealt with third-party patient assistance programs, a topic discussed throughout the conference.

The panelists also covered working with third-party vendors and the need for monitoring and testing of those vendors to ensure they are complying. As one panelist put it, “you need to be sure those companies are applying your standards.”

Stakeholder Spotlight – Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide   

Gail Cawkwell, Medical Affairs at Intercept Pharmaceuticals, Cecilia Matthews, Human Resources at MedImmune, Gregory Moss, Deputy General Counselor at Kadmon, and Gary Cupit, CEO of PortA Pharmaceuticals provided the business perspective on the compliance/business partnership. The panelists reiterated key points from the CCO session, with one emphasizing the need for the two departments to tackle the issues together as business partners and another seeing compliance not as a goal, but “a base objective that underlies everything.”

One panelist emphasized the need to be aggressive in the approach, pointing out that she is the person “bothering the compliance department, digging into SOPs, asking why they do things that way, and asking how each policy helps the company.”  She prides herself on partnering with compliance to “find a better way to do it.”

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel – Past and Present Prosecutor Parley

A large group of current and past government enforcement representatives covered the current compliance risks facing the life sciences industry. The session started with a discussion about the nation’s opioid crisis and how each office is addressing the epidemic. One current assistant U.S. attorney summarized the threat to the industry succinctly, “If your company is involved in opioids at all, you are under intense scrutiny.”

In one of the more interesting moments of the conference, the panelists pointed out that the focus on off-label enforcement has shifted away from large pharmaceutical companies to smaller ones. According to one speaker, small companies and startups are under greater pressure to sell and to save money, especially if they are funded by venture capital companies. That leads to a higher risk of off-label promotion.

Continuing a theme, prescription assistance programs and patient charities were addressed in relation to kickback risk. As stated, “any coordination between the charity and the company that shows the company is just trying to pay for its product being prescribed is a concern.” At least two current regulators supported the idea of self-disclosure and being honest about potential violations. “Being candid about where the compliance program has fallen short and the steps the company is going to take to correct the problem is important,” one of them said.

The group of former regulators, who mostly now serve as industry counsel, touched on exclusion as a risk. While it may be considered a rarely-sought tool, prosecutors have the threat of exclusion available to them as leverage. They also delved into the importance of data and reminded the audience that prosecutors are indeed scouring Sunshine Act data.

Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions

Attendees were provided five options for the first breakout sessions. The PAP and Hub Services panel was moderated by Jane Yoon of Paul Hastings LLP, and featured Peter Agnoletto of Sanofi, Sarah Whipple of Akebia Therapeutics, and Evan Bartell of KPMG LLP.

The discussion began with a polling question asking attendees where the management of donations sits in their organization. Corporate Social Responsibility and the Grants Committee were the top answers. The question led to a discussion over best practices, with one speaker warning, “you at least need to take commercial out of any involvement with donations.” Another admitted that not having a say in how the money is spent is hard concept for the business to grasp but the separation is important.

In the next polling question, attendees were asked if they monitor relationships and interactions with the foundations. 57% replied yes, and 28% said no. The panel reminded the audience that recent CIAs included the stipulation that those relationships are monitored.

Another question was focused on sales representatives and their involvement with donations. 48% of the audience said their reps are provided with talking points. Panelists suggested that if the sales reps are involved, compliance needs to understand how the information is being used. Clear guidelines need to be established and the reps need to be trained on those guidelines.

Off-label Communications – Deep Dive into the New Regulatory Updates and Actions

Angela Rodin of KPMG LLP and Laura Terrell of DLA Piper LLP presented the update on the status of off-label promotion trends and enforcement in the industry. Starting in 2012, enforcement shifted, as companies argued that off-label marketing is protected under the First Amendment and therefore cannot be prosecuted under misbranding provisions of the Food, Drug, and Cosmetic Act (FDCA). One presenter pointed out that while the government is no long pursuing off-label promotion as a stand-alone FDCA case, it continues to enforce False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases related to off-label promotion.

The bottom line is that even with strong support of free speech as a defense of off-label promotion, life sciences companies still need to be cautious. Clear and effective training is still needed.

Social Media – New Challenges and Updates

Elizabeth Kim of Loeb & Loeb LLP began the social media presentation with the underlying premise that while the digital landscape has changed dramatically over recent years, the legal landscape remains the same. Even on social media, promotional statements cannot be false or misleading and communications must be consistent with labeling and fair-balanced.

Social media is challenging, the presenter stressed, because it promotes a dialogue, which means the company has a lack of control over the conversation. But there are some steps companies can take that at least help with the control. The ability for readers to comment on posts can be turned off on Facebook. No such control exists with Twitter. In addition, key words can be flagged on Facebook to help monitor comments. Unfortunately, as the presenter noted, most companies lack the resources and personnel to properly monitor social media outlets.

She also mentioned that while companies have no obligation to correct third-party, independent comments, public, unsolicited requests for off-label information must be met with a limited response to contact Medical Affairs only. “If you do reply,” she said, “responses should be narrowly tailored. Watch out for getting into arguments.”

The FDA’s Office of Prescription Drug Promotion (OPDP) has issued 233 warning letters over the last ten years for omitting information, minimizing risk information, and overstating efficacy claims on social media. As existing platforms evolve, and new ones appear, the need for updated training to ensure your field-based employees are abiding by laws like the FCA and FDCA, as well as OIG guidance and the PhRMA Code, is critical.

Medical Affairs and MSL Oversight

The Medical Affairs panel included Tina Beamon, Alicia Temoche, and Stephanie Macholtz from Alexion Pharmaceuticals, and Christine O’Connor-Fiore from Boehringer Ingelheim. The session began with the panelists establishing the general rules for how Medical Affairs may interact with healthcare professionals. Attendees were reminded that Medical Affairs can “do things R&D and Commercial cannot do” and “they are not limited to the label.” MSLs provide training to consultants for speaker programs but in the words of one panelist, “they are not Commercial and their integrity must be protected.”

The panelists admitted that the model for Medical Affairs and Commercial interactions has changed in reaction to marketplace changes. Medical Affairs should share insights as long as those insights are not off-label. “The walls between Commercial and Medical Affairs are coming down,” she said, “and a framework needs to be in place to protect the integrity of the MSL.”

Behavioral Compliance – Using Psychology to Make Programs More Effective

In one of the more unique sessions I’ve witnessed in years of attending compliance congresses, this session focused on behavioral compliance as a tool for generating more compliant outcomes. Yogesh Bahl, of AlixPartners, Kevin Ryan of Novo Nordisk, and Charlene Davis of Sun Pharmaceuticals provided conceptual concepts around the philosophy and practical application of behavioral compliance, using ideas known as “ethical nudges.”

The session began with the audience being asked to provide feedback on which of two compliance posters they thought were more effective. Essentially, one reflected a “rules-based” approach, and the other a “values-based” one. The values-based poster was the more popular choice and the content of the session supported that approach. The underlying premise behind the ethical nudges is that “people become ethical by doing ethical things.” Ethical nudges were essentially defined as “interactions based on the understanding of internal decision-making to promote desirable choices.” They included “read and affirm” documents presented right before a critical HCP interaction, visual cues like signage and posters, and micro-training launched strategically in conjunction with the need for ethical decision making.

Critical CIA and Enforcement Learnings – Zero-In on Emerging Trends to Elevate Compliance Safeguards      

The key points of this session were no surprise considering the oft-repeated focus of recent CIAs. BJ D’Avella of Deloitte and Touche LLP and Seth Lundy of King & Spalding LLP reminded attendees that “the focus of CIAs had shifted to interactions with patients, and more than ever, companies need to have a Risk Assessment and Mitigation Plan (RAMP) in place.” That RAMP needs to include activity-based risks in addition to the usual product-based risks.

One of the presenters pointed out that the OIG is focusing on a “smaller number of CIAs that send messages to the industry.” He reminded the audience that CIAs are not laws, but they are a strong indicator of where to focus risk mitigation efforts.

Day 2

CCO Scenario Symposium – What Would You Do?

After a review of the sessions and events of Day 1 by Michael Shaw of GlaxoSmithKline, Day 2 began with this session, during which panelists were asked to participate in a mock case study of “Bad Pharma Co” and expand on lessons learned from this fictional company. Beth Levine of Regeneron Pharmaceuticals, Ashley Watson of Merck, Jerald Korn of Tesaro, and Keith McGahan of Spectrum Pharmaceuticals were asked to discuss the optimal organizational structure companies like the mock one presented in the case study. One presenter felt that having compliance as part of the legal department was a benefit because it gave her greater access to the CEO and others in the board of directors. Others felt that if compliance has that type of access, “it doesn’t matter where they sit.”

Other scenarios brought up in the case study led presenters to offer tips on dealing with compliance situations and those who raise the concerns. For example, one speaker emphasized that “no matter the source, the company’s obligation is to search for the facts of the case.” Speculation about the whistleblower and his or her credibility should not come into play. Also, “if someone sends information about a violation anonymously, it needs to be kept that way.”

Meeting of the Enforcement Minds

Heather Johnson from the Federal Trade Commission, Sally Molloy from the Department of Justice, and Eric Rubenstein from the OIG presented their suggestions for companies to keep their compliance programs attuned to current regulatory challenges. On the topic of bribery for example, one presenter suggested that “internal controls need to be robust and designed so that they are not siloed. It’s all bribery.” Another emphasized that recent trends point to Medicare and Medicaid fraud as a primary source for qui tam cases.

Beyond the Seven Elements of and Effective Compliance Program – What Else Are You Doing?

As a compliance training company, this session, featuring Jerald Korn of Tesaro, Chad Morin of bluebird bio, and Gregory Moss of Kadmon Holdings, held particularly interest for us. As one presenter stated, “creating a brand for the compliance department is a fun way to convey important information.” That holds true for the training as well, and we work with companies to create a continuous, engaging, and “fun” curriculum.

Another speaker noted the importance of being creative in the policies to help ensure compliant behavior, as well as the need to establish a collaborative culture. As stated, “you’re not trying to check the boxes on all seven elements, you’re trying to build a robust program that is effective.”

Existing and Emerging State Laws Governing Transparency Reporting

The state laws presentation, with Maggie Feltz and Michael Grandison of Purdue Pharma, and Brian Bohnenkamp of King & Spalding, LLP, began with tips for managing aggregate spend:

  • Train company-wide, not just the sales force
  • Train, retrain, then train some more
  • Monitor throughout the year

The panel pointed out that state laws fall into three categories; drug pricing transparency, aggregate spend laws, and sales representative licensing and reporting laws. The landscape across all three changes quickly and they expect 2018 to be as busy as 2017.

In recent state-related news, Maryland’s law was found to be unconstitutional and according to one panelist, that “has quieted some of what other states have been considering.” Oregon was brought up as the most challenging law since it “requires documentation to support your documents.” In New Jersey, where the law was passed on the last day of the outgoing administration, one speaker mentioned that Governor Murphy’s team is considering major changes. On the drug pricing front, the panel expects two or three more laws to be implemented.

Obviously, the state law landscape is confusing and changes are happening at a dizzying rate. As one speaker emphasized, diligence, and continuous training is necessary to “ensure every decision-maker is aware of new requirements.”

Maximization of Compliance Resources

I close with what may have been the best session of the entire conference! (okay, I may be a bit biased since this panel included my colleague, and head of PharmaCertify, Dan O’Connor.) Dan was joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals. The session focused on how compliance professionals can best focus their time and energy toward those activities that are most critical during the various growth stages of a life science company from pre-clinical to established.

Starting with a quick poll of the audience, the panel first determined the average size and stage of companies represented. Most of the audience members were an “n of 1” compliance department in a company with 200 or fewer employees that is in the “Clinical” or “First Product” stage. The panel then shared their suggestions for which compliance-related activities to prioritize during each growth stage. In the “first product” stage for example, aggregate spend transparency reporting; government price reporting; specialized training by function; and patient support program design were discussed, among other topics.

The panelists also covered the need for small departments to partner with the business, as well as other departments, to spread the resource load and accomplish the objectives of each stage. For any compliance department challenged with limited resources and personnel, it was a worthwhile thirty minutes of learning. If you missed the conference, Dan would be happy to provide his perspective on the topic. Feel free to contact him at doconnor@nxlevelsolutions.com.

Summary

The world of life sciences compliance is changing, and so is CBI’s Pharmaceutical Compliance Congress. This year’s conference presented a compelling balance of traditional content that newcomers to the field should find valuable as a base of knowledge, with enough updates on key areas of regulatory focus (off-label, patient assistance programs, state laws, etc.) to keep the seasoned compliance professionals in the audience satisfied with agenda. It also offers industry professionals a rare opportunity to meet face-to-face with their peers and hear best practices for strengthening their compliance cultures and reducing risk. I highly recommend the conference next year for chief compliance officers, specialists, managers, and anyone working in the life sciences compliance training industry. Kudos to CBI and all the presenters!

Thanks for reading.

Sean Murphy
Editor, PharmaCertify Compliance Training Insights Blog

A Preview of the 15th Annual Pharmaceutical Compliance Congress!

The 15th Annual Pharmaceutical Compliance Congress is only a week away and the conference agenda offers a new twist on the standard array of presentations by industry leaders and government regulators. Here are some of the presentations and panel sessions the PharmaCertify™ team is looking forward to:

Day 1: Tuesday, April 24

CCO Exchange
Adapting and Evolving Compliance Programs in Support of Innovation

Following the chairman’s opening remarks, and the “luminary address” that kicks off the conference, this panel session features leading industry representatives, including Maggie Feltz of Purdue Pharma and Sujata Dayal of Johnson & Johnson. The title is intriguing and I look forward to hearing the panelists discuss how they have adapted their programs, and their training curriculum, to take advantage of advances in technology and new concepts like microlearning and continuous learning.

Stakeholder Spotlight
Evaluation of Compliance Programs from the Internal Customer Perspective

The focus on “internal customer perspective” in this session caught my eye. It’s a stakeholder group that is not often discussed at conferences, and I’m curious to hear how the presenters define internal customers and the parameters and tools used tools for evaluation.

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel
Past and Present Prosecutor Parley 

The description of this unique session promises a “point/counterpoint” approach to the subject matter, with current and former prosecutors and defense attorneys presenting their views on recent settlements and on-going investigations. Typically, the two sides present in separate sessions, so this joint “parlay” approach should prove to be engaging and revealing.

Patient Assistant Programs (PAPs) and Reimbursement Hub Services Compliance
A New Wave of Enforcement Actions

The latter part of the title makes this session so compelling and the “wave of enforcement actions” has led to several of our clients asking about training on PAPs and Reimbursement Services compliance (look for that addition to our curriculum of customizable off-the-shelf compliance modules in the near future). I am curious to hear how the industry representatives on the panel are dealing with the need for training considering the growing regulatory focus.

Master Class Series 3
Behavioral Compliance – Using Behavioral Psychology to Make Compliance Programs More Effective

This one is on the top of my list! After spending over ten years in the life sciences compliance training space, I recognize the key to flattening the proverbial “forgetting curve” is the utilization of modern and continuous learning tools and techniques built on advances in behavioral psychology and the science of learning. Look for me in the front row!

Day 2: Wednesday, April 25

Patient Support Programs Track
All Three Sessions

Continuing the focus on Patient Assistant Programs and Reimbursement Hubs covered in one session on Day 1, this track features three sessions that should shed light on a burgeoning area of enforcement: Evolving Role and Landscape of Patient Advocacy in Life Sciences; Mitigate Risk Within Hub Operations; and Legal Nuances and Limitations of Drug Copayment Offset Programs.

Small to Mid-Sized Bio/Pharma Working Group Track
Beyond the Seven Elements of An Effective Compliance Program – What Else Are You Doing?  

The definition of an effective compliance program has evolved well past the point of simply covering the seven elements first established by the OIG years ago. From a training standpoint, modern continuous learning techniques and tools have the potential to increase the retention of key compliance concepts and further reduce risk. I am curious to know what strategies the four industry professionals featured in this session have integrated into their programs to make it even stronger.

Small to Mid-Sized Bio/Pharma Working Group Track
Maximization of Compliance Resources

I may be a little biased on this one since my colleague, Dan O’Connor, will be joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals to discuss strategies for building and maintaining a strong compliance program when resources are at a minimum due to staffing and budgetary constraints.

Transparency and Open Payments Track
CMS Transparency and Open Payments Update
Existing and Emerging State Laws Governing Transparency Reporting
      

With transparency being such a regulatory focus and risk area, I anticipate a large and rapt audience for the presentation by Robin Usi, Director for the Division of Data and Informatics at CMS. In addition, the ever-changing list of states updating their existing transparency laws, as well as those launching new regulations (we see you New Jersey), moves the second session high on our attendance sheet.

Compliance Café and Community Exchange

Kudos to CBI and the panelists involved for this novel and clever way of closing out the conference! This collaborative session offers a great opportunity for attendees to collaborate with their peers and exchange ideas and suggestions from what they heard throughout the conference, and most-importantly, “align learnings and develop next-level strategies to take back to the office.” Well done.

The 15th Annual Pharmaceutical Compliance Congress promises a plethora of opportunities to catch up on the latest in regulatory and enforcement news, as well as best practices for building and strengthening an effective compliance program. We hope you’ll take a few minutes in between sessions to visit the PharmaCertify Booth in the Exhibit Hall to say hello and see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients.

Thanks for reading and we’ll see you in Washington!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

“Dear Connie the Compliance Training Specialist” is back!

Welcome to this edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about timely compliance topics and delve into the best training for reducing risk.

This week: raising knowledge retention at the next POA.

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Dear Connie,

During the compliance portion of our last Plan of Action meeting, I introduced several scenarios for group discussion with the hope of making the session more engaging. For the most part, I think it was more successful than just reviewing a slide deck (our usual approach), but not everyone was engaged and I’m not sure they’re going to remember the key points. Any suggestions for our next workshop?

Signed,

Bewildered in Bridgewater

Dear Bewildered,

Kudos to you for making the effort to move beyond the “PowerPoint Overload” approach to live compliance training. To engage the entire audience, I suggest you “gamify” the discussion and have everyone team up to solve scenario-based challenges. Research has shown that creating a competitive environment raises the retention of key lessons and makes the content stick with the learners.

Here are a few suggestions that can add a level of interactivity, even if the time allotted to compliance is limited:

Form Teams

Competition is more fun and learning is enhanced when groups of participants work together to solve the scenario. Instead of asking individuals in the audience to give their opinion, create teams of participants based on regions, products, or any number of qualifiers. To save time at the session, create the teams ahead of time, in the planning stage.

Add Activities

Don’t just ask the teams to present their best suggestions for a scenario. Add activities that stimulate cooperation within the team. For instance, you can employ a card-sort exercise with scenario “flashcards” the teams sort into two piles, e.g., “permissible” and “not permissible.”

Teams can also compete against one another to solve a scenario-based “mystery” using their understanding of compliance best practices and company policies. Provide clues (emails, call transcripts, receipts, and text messages) during the workshop or ahead of time via email.

The activities can be developed in analog (paper-based) form or electronically through an online gaming platform or outside vendor.

Keep Score

Enhance the competitive spirit even more with a leaderboard that you update manually or electronically. Display the board continuously during workshop, or only after each activity is completed. If you send out questions in the weeks before the workshop, tell the learners they get points for how quickly they respond and for accuracy. Add those scores to the leaderboard as well.

Remember the Debrief

Don’t forget to leave time to debrief the audience once the activities are completed. You need to make sure the nuances and “gray areas” are understood, and the participants understand which company policies to reference for on-going guidance around the topics that were covered.

These are just a few tactics for raising the retention rate and “making live compliance learning stick.” My friends here at the compliance training division of NXLevel Solutions have experience creating compliance workshops for a range of life sciences clients. Feel free to contact them at 609-483-6875 to hear more ideas.

Thanks for the great question!

Connie the Compliance Training Specialist