A Preview of the 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress

Visit the PharmaCertify booth at the Pharmaceutical and Medical Device Compliance Congress to see demos of our newest modules, reinforcement programs, and games!

Here we are, over a year after Covid completely upended our lives, personally and professionally, and we are still attending compliance conferences virtually. The Pharmaceutical Compliance Forum (PCF) opted for a virtual forum for the Pharmaceutical and Medical Device Ethics and Compliance Congress again this year and a quick review of the agenda highlights the notion that no matter the format, this conference consistently presents the information any compliance professional needs to help reduce risk. Here are my pre-conference thoughts on the sessions of interest, particularly those that affect compliance training curricula.

Day 1: Tuesday, November 2, 2021

In an interesting twist on the standard agenda format, PCF opens the congress this year with a series of concurrent mini summits covering a range of topics. My standard advice applies; divide and conquer. If you’re attending with colleagues, plan to attend different presentations, then share notes. Even if you attend on your own, find a friend in one of the early networking sessions and don’t be shy about asking if they are interested in taking the same note sharing tact. It’s a veritable plethora of content to wade through…and that is definitely a good thing.

Mini Summit 1: Enforcement Action Updates

I tend to include most of the enforcement panels in these preview blog posts simply because they’re rare opportunities to hear the experiences and advice of those on the forefront of actions and settlements, including topics that trainers should be concerned about. This conference is no exception. Panelists include Assistant US Attorneys from the Eastern District of Pennsylvania and the District of Massachusetts, as well as the Assistant Director of Civil Division/Fraud Section of the Department of Justice.

Mini Summit 3: Evolutions of Investigations

The title for this one caught my eye and moved to the top of my priority list. Investigations have formed the foundation for the industry’s focus throughout the growth of the compliance industry and they certainly influence the training that has evolved from the early days of PowerPoint presentations to the multi-layered foundational and reinforcement training that is now considered the vanguard of effective eLearning.

Transition Breaks and Lunch

I include the breaks in this “must attend” list of sessions because they offer the best opportunity to interact directly with peers, vendors, and consultants. These are the people who not only provide crucial funding for the conference but also offer the products and services you need to help reduce risk and build a stronger culture of ethics and compliance. We’re here and we’re anxious to meet you. So, I invite you to check in with these critical vendors in the exhibit hall.

Mini Summit 5: DOJ/SEC FCPA Panel

Please see my thoughts on Mini Summit 1. The same apply to this session focused on the Foreign Corrupt Practices Act.

Mini Summit 7: Annual Medical Device Update

Hooray for Medical Device! It’s in the conference name and it is rightfully in the agenda. While many of the topics listed throughout the agenda apply to medical device companies, concerns and challenges unique to the industry abound. The panel includes chief compliance officers from Medtronic, ZOLL Medical, and Olympus, as well as a representative from AdvaMed and I’m looking forward to hearing how they address the issues associated with the rising number of recent medical device settlements.

Open Forum with PhRMA and AdvaMed

The Senior Assistant General Counsel for PhRMA and Vice President, Global Compliance and Governance for AdvaMed will be available in an open forum, hopefully ready and willing to take your questions. Enough said.

The Pivotal Role of CCO’s in Fostering a Strong Culture of Inclusion, Trust, and Psychological Safety

After a break, the conference switches from concurrent summits to this important and timely general session. I’m especially intrigued by the phrase “psychological safety” in the title, and I look forward to hearing whether inclusion and diversity are included in the discussion.

“Evolving our Operating Model” Discussion Breakouts

For the final session of the day, attendees choose one of three titles: 1. Managing Remote Teams, 2. Scope and Structure of the Compliance Function, and 3. Ethics and Compliance – The Road Ahead. To borrow a cliché, Covid has clearly changed the world and our industry for the long term. While the same core principles apply no matter how business is conducted and even how training is launched, compliance challenges shift and grow with the advent of virtual interactions. That’s why numbers 1 and 3 are of particular interest to me.

Day 2: Wednesday, November 3, 2021

Day 2 kicks off with more mini summits and interactive workshops followed by the opening plenary session at 1:00 pm.

INTERACTIVE WORKSHOP III: Hot Topics in Medical Device

Medical device is back with its own workshop and that is definitely a good thing! I look forward to hearing what topics Sujata Dayal from Medline Industries and Dana McMahon of Stryker include in their presentation and comparing the list to what we cover in our off-the-shelf and custom training solutions we provide for our medical device clients.

MINI SUMMIT 15: Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance

I confess, since my colleague, Dan O’Connor, is the moderator on this one, I may be a bit biased. But I’ve seen the initial outline for the presentation and trust me, you don’t want to miss it. Dan, and his panel of compliance professionals will delve into the landmark guidance from the DOJ and present a practical framework for building and managing a continuous curriculum of training that will help your organization align with its principles.

MINI SUMMIT 16: Patient Assistance Programs

Speaking of hot topics! Regulators are paying attention to your patient programs, and you should be doing the same. So, you don’t want to miss this opportunity to hear Noor Haq from Amgen and Kevin Ryan from ACADIA share their experiences and tips for managing and minimizing the compliance concerns associated with PAPs. By the way, here at PharmaCertify, we’ve developed a new customizable eLearning module covering patient programs. Visit our website to see a description.

INTERACTIVE WORKSHOP 4: How to Establish Risk Tolerance in an Emerging Organization

If your company faces the challenges unique to those that fall into the emerging category, this holds the potential to be one of the most valuable sessions on the docket. Terra Buckley, who is now the Vice President of Compliance Advisory Services, is a seasoned industry professional, and frankly, one of the most dynamic presenters I have seen on all topics related to life sciences. Terra will be joined by David Ryan, Chief Compliance Officer at Epizyme.

Opening Plenary Session

Several presentations are listed as part of the plenary session that runs from 1:00 pm to the close of the day’s agenda at 5:30 pm.  

Keynote: OIG Update

Following the fireside chat with Giovanni Caforio, MD, Chairman and Chief Executive Officer at Bristol Myers Squibb, Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General at OIG will deliver her annual update on the agency’s enforcement actions and workplan. It’s always a highly anticipated presentation and for good reason. Her slides and notes form a solid foundation for where companies should be focusing their efforts and their resources in the coming year. 

Response to OIG Special Fraud Alert and PhRMA and AdvaMed Code Update

The conference organizers have combined these three weighty topics into one presentation, and I am anxious to hear the panel of industry professionals and representatives from PhRMA and AdvaMed delve into the important details of each one. The Fraud Alert and the updates to the two codes led to significant changes in the content for our off-the-shelf and custom training courses at PharmaCertify, and we’re developing reinforcement components like a brief explanatory video describing the PhRMA Code to roll out in conjunction with the updated foundational module.

Annual Chief Compliance Officer Fireside Chat

Day 2 ends with an impressive lineup of chief compliance officers from pharma and med device, representing companies of different sizes and therapeutic focus. Ann Beasley, from Zai Lab, Shefari Kothari from Novartis, Angela Main of Zimmer Biomet, Kristin Rand from Moderna, and Latarsha Stewart from Servier Pharmaceuticals are sure to add a compelling exclamation point to a day chock full of critical compliance experiences and advice.

Day 3: Thursday, November 4, 2021

Following the form of the first two days, Day 3 begins with a series of MINI SUMMIT 21: Interactions with Health Care Professionals

Interactions with healthcare professionals are the foundation upon which solid compliance practices, principles, and training must be established. Whether those interactions are in person or virtual, they are fraught with risk, yet when they are conducted in a compliant manner, they continue to form the core of what makes the life sciences industry what it strives to be; a noble group whose primary focus is helping its customers improve the lives of patients. That’s why I’m looking forward to hearing the best practices for those interactions espoused by a panel that includes representatives from both the pharmaceutical and medical device industries.

INTERACTIVE WORKSHOP V: Evolution of Ethics & Compliance

We have been hearing about the industry shifting away from “a culture of compliance” to an “ethics-based” approach to compliance for a few years now. While the notion is a laudable one, the practicality of that migration is more challenging in such a risk-based environment. I am eager to hear the presenters’ tips for executing that evolution, including how they carry it through to their compliance training.

MINI SUMMIT 25: Trends in FDA Advertising/Promotion Enforcement: Know the Risk Areas

Any session with “Know the Risk Areas” as part of its title gets my attention and when the focus is on advertising and promotion it’s no exception.

Closing Plenary Session

The afternoon on Day 3 includes a plenary session with a series of interviews and sessions. After a keynote interview with Tim Wright, the Chief Executive Officer from MiMedx and a fireside chat with Rady Johnson from Pfizer, Catherine Gray from the FDA presents the annual FDA Keynote. Like the OIG Update from Mary Riordan, the review of the FDA’s workplan is worthwhile and important. And the AUSA Roundtable offers another valuable view of current trends and hot topics from those on the regulatory side of the table.

Day 4: Friday, November 5, 2021

Industry Only Best Practices Think Tank  

I’d like to wax poetic about this, the final session of the conference, but I remain relegated to the figurative “kids’ table” of vendors and exhibitors who can only wonder what juicy nuggets of compelling and important information those insiders are discussing behind their locked virtual walls. In the meantime, I continue to stare at my email inbox, awaiting my golden ticket. Here’s a suggestion for the PCF team: perhaps an outline of the ideas and suggestions discussed during the session could be shared with all attendees after the conference concludes.

Summary and Complimentary Conference Registration

That’s quite a bit of content for any conference, so kudos to PCF and the organizers for creating such a hefty agenda and gathering so many impressive presenters. And I’ve only scratched the surface of the list of mini summits and plenary sessions. If you’re attending the conference, I invite you to stop by the PharmaCertify booth to see demos of our newest compliance training programs, workshops, and games. You don’t want to miss our new Compliance JEOPARDY!® game, the only officially licensed one on the market!

If you haven’t yet registered, we can help! As a conference sponsor, we are offering a limited number of complimentary registrations. Just contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to take advantage of the opportunity to learn from your peers and fellow compliance professionals. You don’t want to miss it.

Thanks for reading and I will see you online for the conference!

Sean Murphy
PharmaCertify by NXLevel Solutions

Five Ideas for Your Compliance Session at the Next National Sales Meeting or POA

Your next national sales meeting or POA is just around the corner! If you haven’t thought of a fun and engaging way to make the content stick during your time in front of the reps, especially with the move to virtual events, all is not lost. There is still time to craft a compelling session to help ensure key compliance concepts are communicated effectively and learning is optimized.

Here are five ideas that might just have your participants saying, “that was the best compliance session I’ve ever attended!” Trust me, it does happen. I’ve seen and heard it myself.

Play Compliance JEOPARDY!

Jeopardy-style games have long been a staple of compliance training and the familiar format continues to be a great way to get your learners’ competitive juices flowing. It’s a popular format that your audience will recognize instantly.

PharmaCertify offers the only officially licensed JEOPARDY! game on the market and wow is it cool! You can populate the game with categories and clues written by our subject matter experts or draw questions from your own policies. Either way, our instructional designers will work with you to create a series of clues that challenge the participants’ knowledge at just the right level to enhance the learning.

Compliance JEOPARDY! is flexible. We offer a baseline off-the-shelf version to get you started, and depending on the amount of time you have at the meeting and your learning objectives, you can include up to 51 clues in one game (including Double JEOPARDY! and Final JEOPARDY!)

Make It a Compliance Mystery

Who doesn’t love a good mystery?  A mystery-themed workshop is an ideal way to present new compliance concepts and reinforce existing knowledge in a live, or virtual, collaborative and information-sharing environment.

When created thoughtfully and using sound instructional principles, a mystery workshop can draw the learners in as they play “compliance detectives” to solve scenarios through their knowledge of compliance best practices and guidance. You can even make it a blended event by rolling out “clues” in the form of email messages, voicemail transcripts, and text messages, before the date of the workshop.

At PharmaCertify, we include a compliance mystery activity in our Compliance Reality Challenge. Participants begin the Compliance Mystery by reviewing the clues they were presented prior to the workshop. Once they complete that review, they are presented with a screen from which they choose red flags. They then answer a series of questions to test their understanding of the scenario and their decision-making skills.

Following the completion of the activity, facilitators briefly have the opportunity to review the scenarios and provide clarification on policies as necessary. After the workshop summary and a review of the key lessons learned, a leaderboard can be revealed to highlight the final scores.

Build a Virtual Compliance Escape Room

Escape rooms are all the rage, and a virtual escape room can be a great device for transferring that popularity into a memorable learning activity.

The escape room can build trust and collaboration as participants work in teams to solve challenges and use codes to escape. An escape room can be a blended event, with core training and other pre-work delivered prior to the activity, which will allow you to focus on specific concepts during your time with the participants.

Escape room activities begin with a scene for the group of learners to explore. Each participant clicks on each “hotspot” to review key information. Once all hotspots have been explored, a “Next” button appears, and participants are presented with a series of questions regarding the scene. As members of a team answer questions, the score for that team is averaged automatically to generate a final team score. The workshops are generally designed for a 45-minute duration, and include introductory remarks, debriefs between activities, and wrap-up remarks.

Build Your Own Compliance Scenarios

Scenario-based learning is a tried-and-true method for helping learners improve their decision-making skills. Scenarios give your reps the chance to apply knowledge from previous training in a safe environment.

Our Compliance Scenarios training game is an easy way to create role-play situations for your next meeting. With Compliance Scenarios, you can transport the audience into simulated interactions with healthcare professionals during the training session.

We’ll work with you to develop discussion points for a series of branching scenarios, and we’ll create the photo or illustrated images to go along with the content. When learners think critically to solve a simple or complex scenario, retention is increased, and learning is enhanced!

Pursue Trivia (see what I did there?)

Who doesn’t like trivia? In fact, did you know that new versions of TRIVIAL PURSUIT are still being released. There’s a new “Master Edition” available with over 3,000 questions? Looks like my holiday shopping list just got a little longer.

Whether they are played online, around the kitchen table, in a bar, or during your company’s training meeting, trivia games are a powerful way to pull participants into a fun learning experience.

Compliance Trivia by PharmaCertify is customizable and can turn your session into a competitive experience through an assortment of question types, including multiple choice, select all that apply, image match, and polling.

Even if you’ve already mapped out an activity for that next meeting, but you need one more reinforcement activity to fill the time available, Compliance Trivia will leave your audience brimming with confidence and compliance knowledge.

Summary

The time available to capture the audience’s attention at a sales meeting may seem fleeting but the lessons your participants learn will be incorporated in their daily work activities well beyond the session. Themed workshops and games are just a few of the options available to “make the learning stick,” but an engaging and meaningful session is a necessary and important step in the continuous process of reducing risk and creating a stronger culture of compliance and ethics in your company.

Thanks for reading. As always, I welcome any comments or feedback.

Sean Murphy
PharmaCertify by NXLevel Solutions

Reduce Compliance Risk: Play a Game

In this week’s post, Dave Correale, Senior Instructional Designer at NXLevel Solutions, discusses the benefits of using games to reinforce key compliance concepts and make training more engaging.

Imagine you’ve been given a 30-minute slot at an upcoming sales meeting. You’d really like to use the time to reinforce your company’s privacy principles, but you don’t want to just present a boring slide presentation. You know a game would be more fun, but would it be effective? How do you build a game around privacy principles, anyway? Besides, you’re not sure you even have the time or resources to build an effective game.

Let’s explore the first question: Would it be effective? While some of the more ambitious claims surrounding game-based learning are not yet substantiated by research, there is strong evidence that games can increase learner motivation and engagement, critical factors in the success of any learning program.

But how do you build an effective learning game around a topic like privacy? One mistake some people make when implementing a training game is they focus too much on the game and not enough on the objectives. Games are not a panacea. A game will likely not be effective for learning if it is not designed to meet specific instructional objectives. And just because a game is effective for one set of learners, in one specific circumstance, it not necessarily be effective for all learners in all circumstances. Just because you are using a game for learning, you cannot ignore valid instructional design principles and practices.

Fortunately, there are many types of games to meet many different types of learning objectives in a variety of circumstances. The level of participation itself can be diverse: games can involve teams or individuals playfully competing against each other in real time, or they can involve single players whose only competition is the game itself.

Let’s return to your 30-minute slot at a fictional sales meeting. Your goal is to reinforce learning on a topic your learners should already be familiar with. You could have employee teams play against each other in a “Jeopardy-style” contest. We’ve all seen the actual Jeopardy!® board – there’s room there to deliver a lot of content. But instead of bullet points, you’re leveraging familiar game show mechanics to raise curiosity among the learners and harness their competitive instincts. You can also build deeper connections between your employees and engage virtual employees in something more than just polling questions.

Single-player games also afford a number of possibilities. Perhaps your company is concerned with the number of recent settlements involving speaker programs. Players could work their way through an unfolding speaker program scenario where they need to engage with the speaker before the program and then respond to situations that arise during the speaker’s presentation. As they respond to each situation, the game moves forward, learners see the consequences of their decisions, and important lessons are learned or reinforced.

Finally, what about the time and resources required to design and develop an effective game? This is why PharmaCertify’s library of learning games is a good fit for ethics and compliance teams. Our collection of prebuilt games, which includes the only official Jeopardy!® game available, are easily customized to help you increase learner engagement and meet your learning objectives while requiring a fraction of the time and cost required to build a game from scratch. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to see a demo and start planning your next compliance training success story.

And look for additional posts in the future that continue to discuss how game-based learning solutions can help you reduce compliance risk and strengthen your culture of ethics.

Thanks for reading!

David Correale, Senior Instructional Designer, NXLevel Solutions

Key Training Takeaways from the 2021 Virtual Compliance Congress for Specialty Products

Although Informa’s virtual 2021 Compliance Congress for Specialty Products was targeted to those companies that focus on rare and orphan diseases, many of the key messages shared by the panel of industry professionals and regulators were applicable to compliance professionals from companies of all shapes and sizes.

Here are some of the key takeaways from the three-day conference, with my thoughts on what those messages mean for your compliance training program:

To say the pandemic has changed the way life sciences conducts business may be cliché, but based on the presentations in this conference as well as the Pharmaceutical Compliance Congress in April, at least some of those changes are here to stay. Change begats an increased volume of risk, and in the opening session, Keeping Up with Industry Trends — Top Compliance Concerns Facing CCOs, presenters emphasized the need for risk assessments now more than ever.

1. The current pace of change highlights the importance of risk assessment.

You need to take the same approach with your training curriculum. What are the key risk areas based on your company’s products? How often are the topics relevant to your product covered in live and online training? Are key areas addressed with reinforcement and just-in-time training? We call this process the Compliance Curriculum Analysis Process (CCAP). In fact, I wrote about how the process can improve outcomes for the publication, Life Science Compliance Update, back in 2017. Thanks to the pandemic, and increased governmental scrutiny, it’s even more relevant today.  

2. Choose the right company when making a career move.

While most presentations in compliance conferences are focused on the best practices and concepts necessary to optimize a program, hearing one of the presenters stress the need to be aware of culture before joining a company was refreshing and enlightening. As the presenter pointed out, you cannot be shy about exploring whether the company makes compliance meaningful and if compliance is valued – before you accept a job offer.

Don’t forget to explore their approach to training as well. Are they regularly rolling out the kind of creative training and microlearning that helps flatten the “forgetting curve” my colleague Dan O’Connor, Erica Powers of Sage Therapeutics, and Karen Snyder of Ironwood Pharmaceuticals addressed in the Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance session? (By the way, you really should see the slides from that presentation and the examples of fun an innovative training your peers are using to help reduce risk. Drop me an email at smurphy@nxlevelsolutions.com if you’re interested.)

3. Equip leaders with consistent and proper messaging.

In a twist on the familiar “tone-from-top” mantra, another presenter in the opening CCO session stressed the need for the compliance department to take the lead in providing leadership with the proper messaging needed to reinforce that tone. As he said, “consistency is key as you cascade communication across your program.” It applies to training as well. Not only does the C-Suite need to be trained in the same concepts and policies as employees, they, and the management team, need to be repeatedly reminded of the need for a seamless message. As we’ve been told in just about every conference over the last five years, you need to earn a “seat at the table” with leadership. Once you’re in that proverbial seat, helping them espouse the messaging necessary to keep your program consistent is the key to keeping it meaningful.

4. Don’t decline meetings during the pandemic.

During the Compliance During a Pandemic session, presenters spoke at length about the importance of open lines of communication and the need to make every attempt to meet with business colleagues whenever possible. The businesses and field employees need to know you are accessible when they have questions. As another presenter chimed in, “you need to constantly make sure they know who to go to.”  That concept extends to your training curriculum. Does your training include surveys and other feedback mechanisms? Do you encourage outreach in your eLearning? Creating and nurturing an open dialogue can only make your training more effective, during the pandemic and beyond.

5. If you’re going to have live speaker programs, you need to be wary of red flags.

That’s according to one presenter during the prosecutors’ presentation on high-priority risk areas. As he put it, the very fact that HHS even issued the Special Fraud Alert on Speaker Programs should be interpreted as a warning. While multiple presenters in other sessions suggested their companies will move to hybrid models with virtual and live programs, the opinions of the prosecutors were clear: expect the OIG’s focus to be on the live versions.

Managing Speaker Program Risk is one of the newly updated Compliance Foundations eLearning modules available from PharmaCertify. It covers the critical content your reps need to understand to remain in compliance, and like all our modules, it’s easily customized with your policies and content! Contact me to see a demo.

6. Not every patient advocacy organization is the size of the American Diabetes Association.

Day 2 kicked off with the Optimize and Mitigate Risk within Patient Interactions and Support Programs. Presenters noted the trickiness in dealing with advocacy groups in particular – not all the groups will be large and experienced enough to understand the potential pitfalls of compliance. You may need to educate them on the guidelines and principles, and that can be a challenge, especially on the delivery front since outside learners often don’t have access to your internal learning management system.

PharmaCertify can help with the Access LMS platform. Access LMS is a cloud-based, affordable alternative for reaching outside vendors and organizations with your compliance training. It’s simple, it’s easy-to-use, and it won’t break your budget. Contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to see a demo. 

7. Dig deep into the weeds with MSL/commercial training.

The relationship between the medical and commercial divisions is nuanced and fraught with risk. During the Compliant Frameworks for Medical Affairs and Commercial Interactions session, a presenter whose company recently launched its first product reinforced the need for detail. While medical/commercial interactions have always been a pain point for her, she clarifies gray areas on topics such as “the rules for visiting HCPs together,” with what she calls “ways of working documents that clarify what each group can do and why.

At PharmaCertify, we take the same approach with our MSLs and Sales Reps: Understanding the Divide Compliance Foundations module. The content is designed to cover each role in a manner that helps reps and MSLs understand their own rules as well as those of the other group. I’d be happy to send you a content outline.

8. Follow the money. The prosecutors are.

It’s no secret that the government is scouring Open Payments data. And they are following the trail of money flowing to HCPs. During the enforcement panel, one prosecutor bluntly stated, “if you pay a provider hundreds of thousands of dollars, we are going to be looking at it.”

Reps need to consistently be reminded of HCP spend limits and incorporating microlearning components like on-going assessments and quizzes into your curriculum is key to ensuring those numbers are top of mind. We’d welcome the opportunity to show you how it works.    

Summary

Kudos to Informa and all presenters for putting forth a valuable and important learning experience despite the challenges that always accompany a virtual event. The pandemic has changed the way in which we share ideas, best practices, and personal experiences as much as it has changed the industry in general. As the world inches back to a more “normal” approach to information sharing, I anxiously await the day when we can again meet in person in a conference exhibit hall and exchange ideas for how you can reduce risk and build a stronger ethical culture through training.

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Messages from the 2021 Virtual Pharmaceutical Compliance Congress (And How the Messages Affect Your Compliance Curriculum)

In what was hopefully the last of the “virtual” compliance conferences (fingers and toes crossed), the 2021 Pharmaceutical Compliance Congress (PCC) offered time-tested and established standards (insert “tone from the top” and “ethics-based approach” here), thankfully blended with new best practices, trends, and suggestions from an impressive list of industry executives and government representatives. Some of the key messages from the three-day conference are listed below, along with my thoughts on how those concepts affect your training curriculum in 2021 and beyond.  

1. OIG’s Special Fraud Alert on Speaker Programs still ripples across the industry.

The comments surrounding the OIG’s Fraud Alert released last November certainly were not revelatory, but the fact that industry insiders and regulators are still stressing its importance is meaningful. The Alert was referenced right out of the gate in the presentation by Jim Stansel of PhRMA, and one presenter in the Enforcement Trends presentation summarized its impact by saying, “OIG has thrown down the gauntlet on speaker programs with the Fraud Alert.” As the industry moves away from virtual engagements toward more in-person programs, expect intensified scrutiny.

Speaker programs remain a hot topic for enforcement, and as the industry emerges from the pandemic, your learners need refresher training on the foundational rules of compliant speaker programs and the key concepts associated with those programs. We can help, with our recently updated PharmaCertify Foundations eLearning module, Managing Speaker Program Risk.

2. Data is your friend. (Or should that be “Data are your friend? That one always confuses me.)

The need to scrutinize data has been a recurring topic of conversation, and this year’s PCC was no exception. Having access to data in the right form and unitizing that data to identify trends and outliers is key to an effective compliance program. “Be proactive to dig deep into the data,” one presenter at the Chief Compliance Officer Showcase on Day 1 suggested, “and identify field personnel who are consistently right at the meal limits.”

In life sciences compliance, the devil is in the data, and an informed evaluation of data is critical when updating and optimizing your compliance training curriculum. What is the data telling you? If you’re seeing concerning trends, you’ve got a training challenge. And if you’re not seeing any trends, you’re probably not looking hard enough, or you’re not gathering the right data. As my colleague, Dan O’Connor, pointed out in the Creative Compliance Training Solutions presentation, “when you send out post-training surveys, don’t ask the learners if they liked the training, focus on what they learned and ask them what they can apply in their jobs.” The data is out there, you just have to find it.

3. An ounce of compliance prevention is worth a pound of effectiveness.

In the Former Prosecutor Panel, one presenter emphasized the need to proactively address issues, whether a company is establishing its compliance program or reinforcing important policies as the business evolves. “Getting legal advice on the front of the program is important,” he says, “and when you move back to live interactions, refresh employees on the perils of speaker programs.”

No matter the topic, an adaptive approach to learning is the most effective way to ensure your audience is mastering the concepts and policies. Retention is enhanced when training is rolled out on a continuous basis, in the form of microlearning nuggets, where learners are asked to repeatedly demonstrate their knowledge and understanding. You will sleep better knowing you’ve taken steps to reduce risk.

4. Join in the innovation.

During the Chief Compliance Officer Luminary Panel, one presenter pointed out that the pandemic has forced companies to be innovative in how they navigate business activities, and she reminded the audience that the compliance department “should play a big role in that innovation.” The day of compliance and business operating in siloed fashion are long over. “A seat at the table” is no longer a hopeful cliché randomly mentioned at compliance conferences. To facilitate a true partnership under which compliance polices and best practices are integrated into the daily activities of the workforce, everyone involved needs to understand that risk tolerance in the industry has changed, and the only way to reduce that risk is through a unified spirit of collaboration and innovation.

That notion of cooperation and collaboration extends to training. When compliance training and concepts are integrated regularly into each employee’s full curriculum and daily work, learning is enhanced and stronger ethical cultures are forged. And as was referenced on Day 1 of the conference, statistics from the Ethisphere Institute, an organization focused on defining and measuring corporate ethical standards, show that companies with strong ethical cultures perform better.

5. Evaluate your vendors’ compliance programs as part of your due diligence.

The idea of conducting due diligence before hiring third-party vendors has long been espoused at compliance conferences. But I was intrigued to hear a presenter in the Fireside Chat with CCOs suggest an even deeper dive into a vendor’s compliance program to evaluate whether its practices and principles align with those of your company.

On the training front, that includes a thorough evaluation of the vendor’s compliance training program. Do they cover the high-risk topics pertinent to your company and its products? Do they conduct compliance training in general? How often do they train their employees? How accurate and focused is that training in terms of content? These are the type of questions that need to be incorporated into your third-party vendor risk questionnaire and considered before the contracts are signed.

6. The Sunshine Act rises again.

Too often, life sciences professionals regard Sunshine Act/Open Payments training as a “one and done” event. But as presenters in the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities session pointed out, Medtronic’s recent settlement with the OIG included a payment to resolve allegations that it failed to accurately report payments to CMS. This topic is too big and too risky to not being training more aggressively.

In addition to refreshing the content in our Compliance Foundations module, The Sunshine Act and Open Payments, we recently added The Sunshine Act Payment Categories QuickTake module to our library of customizable off-the-shelf products. The five-minute module is the perfect complement and reinforcement course to the foundational training, which covers the topic at a higher level.

7. The pandemic is not an excuse.

The notion that the pandemic does not give companies an excuse to lose sight of compliance was repeated daily throughout the conference. Industry leaders and government representatives reminded the audience that the shift to virtual interactions and programs will not be viewed as justification for breaking the law or acting in bad faith. Even though the way in which business is conducted has changed, the core principles and rules governing compliance have not.

The same holds true for your training curriculum. Don’t use the pandemic as an excuse to “put off” searching for ways to enhance training and increase engagement. In fact, you should be doing just the opposite as the industry shifts back to more live interactions. We can help with our Compliance Curriculum Analysis Process (CCAP), which is a comprehensive process to identify training gaps and reinforcement opportunities in your training components.

8. Expect continuing focus on foundations and copay assistance.

Enforcement trends around patient support programs and foundations are growing. It’s a topic on the minds of regulators and routinely on compliance conference agendas. As one of the presenters in the Keynote Enforcement Panel on Emerging Trends Enforcement put it, “we are seeing a ton of copay assistance cases in our district.”

Emphasis needs to be placed on patient program training. And to borrow a phrase, we’ve got a module for that. The Compliance Foundations module, Patient Programs and Their Risks, is a great starting point. Module topics include protecting patient privacy, discussing programs with HCPs, working with vendors, and a topic that is top of mind in life sciences – donations to foundations.  

Conclusion

The organizers of the virtual PCC have made the main stage and on-demand sessions available until May 29 for attendees. If you were there, I highly recommend you visit the conference site for content you may have missed or to revisit the sessions most relevant to you and your company. It’s one of the perks of attending a virtual event.   

While Informa made every effort to replicate the look, agenda, and networking opportunities associated with a live event, it cannot match the on-site conference experience. Fortunately, I am told Informa is planning a live conference for the fall, which will be welcomed news if the dates don’t conflict with those of the Pharmaceutical Compliance Forum’s conference. Bring on the real thing!

Thanks for reading; I look forward to seeing you “live and in person” at a conference before too long!

Sean Murphy
PharmaCertify by NXLevel Solutions

Jen Anderson of Vertex, Jackie Parris of Incyte, and Dan O’Connor of PharmaCertify present during the Creative Compliance Training Solutions session at the virtual 2021 Pharmaceutical Compliance Congress.

A Preview of the 2021 Pharmaceutical Compliance Congress…As Seen Through My Compliance Training Glasses

pcc2021In what could be Informa’s final “virtual” compliance congress (fingers crossed), the spring kickoff Pharmaceutical Compliance Congress offers a plethora (sweet…I got to use “plethora!”) of industry leaders and government representatives covering oft discussed, yet still relevant topics, mixed with new and timely entries to the agenda (e.g., transparency tips for 2021, advancing virtual interactions, applying behavioral science to drive an ethical culture).

From a compliance training standpoint, the general sessions and breakout workshops at PCC offer attendees the rare opportunity to evaluate their own programs and curricula against the industry standards espoused by the well-known panelists and presenters. The bottom line: if you want to keep up with your peers, you really should try to be there. We can help make that happen with a sponsor discount on the regular registration rate. Just email me for the details, get yourself registered, and get ready to soak up three days of the information you need to keep your training meaningful.

I’ve perused the conference agenda with an eye toward what each session could mean for you in general and for your 2021 training plan and here are a few of the sessions that jump off the screen:

Day 1: Tuesday, April 27

Refill your coffee cup before 10:15 am, and make sure the rest of your morning/early afternoon calendar is clear because after the chairperson’s welcome, Informa comes out of the gate swinging with three general sessions sure to have you glued to your computer screen.

The fun begins at 10:50 with James Stansel, Executive Vice President, General Counsel and Corporate Secretary at PhRMA presenting the Current Snapshot of Affairs Coming Off an Unprecedented and Politically Charged Year. Could there be a more aptly titled presentation to kick off a life sciences compliance conference after what we went though over the last 12 months?

The content you really don’t want to miss starts flowing with the Fireside Chat with CCOs – Top 10 Items on Their Radar and Why They Should Be on Yours presentation from 11:00 – 12:00. Who doesn’t love a good top ten list? (except of course David Letterman since we are just “borrowing” the concept from him.) Other than maybe “best one hit wonder music acts,” I can’t think of a topic sure to have the audience around the virtual office water cooler buzzing for weeks to follow. And, let’s face it, once someone mentions Come on Eileen by Dexys Midnight Runners, the one hit wonder list just runs out of staying power, while that OIG Speaker Programs Fraud Alert is going to be on the industry’s mind for months to follow. Toora loora toora loo rye ay!

We break for lunch at 12:00 – but as importantly, you have plenty of time to visit the virtual Exhibit Hall and learn about the various products and services available from the vendors. We’ll be at the PharmaCertify booth with demos of our newest eLearning modules and other training tools to help you manage your company’s risk and build a stronger culture of ethics and compliance. We’re creating some cool (and effective) stuff that you really need to see. I implore you…come see us lonely vendors!

File the third general session, the Keynote Enforcement Panel, in the “oft discussed but still quite relevant” category. The panelists here represent the metaphorical heart of the PCC batting order, with an acting U.S. Attorney and a First Assistant U.S. Attorney being joined by a representative of the DOJ and another from a private law firm to hold court (okay, am I pushing the euphemisms too far?) over the audience with the latest list of topics expected to be at the forefront of enforcement this year.

At 3:00 pm on Day 1, the agenda is divided into four simultaneous working groups. All of them look compelling for different reasons, but if transparency training is on your 2021 radar, I suggest Trends from 2020 Transparency Reporting and Tips for 2021 with Terra Buckley and Chelsea Ott, both of Medpro Advisory Services. Terra is one of the best industry presenters I have heard on the life sciences compliance circuit and her recent move to head up the advisory services for Medpro is quite a coup for the company and quite a bonus for its clients. Terra knows the ins and outs of transparency (and all things compliance, for that matter) and she is sure to leave you with actionable suggestions for optimizing your program.  

At the same time, I can make an equally compelling case for the Advancing Digital and Virtual Interactions session, or the Optimizing Compliant Patient Interactions session based on recent headlines and settlements as well as the compliance star-studded panel scheduled for each one. Since the sessions are simultaneous, teaming up with colleagues and taking copious notes to share later is your best option to ensure appropriate coverage. That’s my plan, and if you’re looking for a “study buddy,” I’m happy to join forces. Don’t be shy, call me!

Day 2: Wednesday, April 28

After the annual year in review video presentation, the OIG fraud alert makes its first scheduled appearance at 10:30 on Day 2 with the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities. Considering the buzz it has stirred up in the industry since its release, don’t expect this to be the first, or final, reference to the document during the conference. The FDA Office of Prescription Drug Promotion (OPDP) and Center for Medicare and Medicaid (CMS) will follow at 11:05 and 11:35 respectively, in two sessions that typically prove to be helpful peaks into each agency’s workplan and focal points for the upcoming year.

Then at 12:00, it’s back to the Exhibit Hall. We’ll be waiting in case you didn’t get the chance to stop by on Day 1. After all, look at this top-notch lineup of sponsors and exhibitors ready to hear about your challenges and help you meet you goals!

During the afternoon, the 1:40 session, titled, Former Prosecutor Panel – Answers and Insights from Industry’s Trusted Advisors should offer insight, tips, and suggestions from a panel with unique insight into both sides of the regulatory table. And the CCO & GC Luminary Panel – Leading Strategies to Advance the Business and Accelerate Innovation, scheduled for 3:00, features a list of well-known and respected professionals, including Beth Holly from Regeneron.

At 4:00, attendees again break into one of four simultaneous “roundtable exchanges” to end the day. Depending on your priorities and business profile, you may not want to miss Table Talk A, Speaker Programs or Table Talk B, Insights for Emerging and Newly Commercial Companies, but I would be remiss to not recommend Table Talk D, Creative Compliance Training Solutions. My colleague, Dan O’Connor, will be joined by Jackie Parris of Incyte and Jen Anderson of Vertex to delve into how each company is using innovative training solutions to reduce risk across their companies. You don’t want to miss the demos in this one, so remember to “divide and conquer” across all the sessions if necessary.

Day 3: Thursday, April 29

The final day of the conference features a global tilt, beginning with the IFPMA Spotlight – Deep Dive into Evolving International Best Practices at 9:30, followed by Global Payments and FMV at 10:05, and the EU e-Privacy Directive and the Impact on Monitoring Digital Communications and Social Channels (that one is a mouthful, isn’t it?) at 10:40. Whether your company has a global footprint or not, the life sciences world is a small one and we’ve come a long way since the days of the FCPA being the primary driver of worldwide regulation, best practices, and ultimately, your training curriculum.  

The day ends with a one-hour Diversity and Inclusion Summit at 12:00. It’s a timely and important (if not long overdue) way to close the conference and I will be listening for ideas on how the panelists integrate diversity concepts and messaging into their compliance training.

Summary

Hopefully, the next time I write a compliance congress preview (Informa or PCF), it will be in anticipation of an upcoming live conference. As much as I appreciate the efforts of conference organizers to replicate the live experience virtually, frankly it can’t match the value of gathering in-person. For vendors and industry attendees alike, nothing replaces the insight available through face-to-face interactions.

That being said, Informa has created a compelling agenda for this year’s virtual version of the Pharmaceutical Compliance Congress with sessions applicable to both the new and seasoned life sciences compliance professional. Opportunities, such as this, to hear from esteemed leaders in the field and regulators are rare, and anyone interested in hearing up-to-date data, tips, and suggestions for modernizing and maintaining an effective compliance program should make every effort to attend. Again, we can help with that.

Thanks for reading. I will see you online at the Congress!

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Training Takeaways from the KENX Biopharma and Biotech Corporate Compliance Summit

There is a new player in the life sciences commercial compliance conference space. After focusing on the GxP compliance field for years, the Knowledge Exchange Network (KENX) has joined the lineup of organizations targeting the commercial side of the industry. With Informa Connect (CBI) and PCF setting such a high bar for compliance conferences for years, I was looking forward to the possibility of hearing even more ideas for building an effective compliance program during KENX’s recent Biopharma and Biotech Corporate Compliance Summit webinar.

And that is exactly what happened, as an impressive array of industry leaders and established vendors presented new tips and suggestions for reducing risk and building an effective compliance program for established and emerging companies alike. Here are five key takeaways from the day-long webinar that may help you optimize your compliance training curriculum (that is, after all, our mission and passion at PharmaCertify):

1. “Establish a relationship with senior sales personnel so compliance is top of mind for new hires from the start.”

While the “partner with the business” refrain has been espoused frequently over recent years, the idea of turning to the sales leaders to make sure sales representatives hit the proverbial ground running is a compelling twist – particularly for compliance professionals from emerging companies, where resources are limited. Just as compliance needs to have a seat in the business, the business (and sales) needs to be part of the compliance committee to help establish a baseline of compliance expectations and avoid miscues from the start.

2. “The best practices and the rules are evolving quickly, especially during the pandemic. Keep in touch with your peers to discuss how they are managing the evolution to virtual interactions and changing policies.”

I have written about how the larger compliance conferences offer a rare opportunity for compliance professionals to interact with their peers one-on-one and soak in best practices for compliance. But isn’t it a shame that those opportunities are so rare? They don’t have to be. Organizations like KENX, Informa Connect, and PCF offer smaller one-day sessions focused on a plethora of topics, and even when conducted virtually, these programs offer a chance to connect with those who are dealing with the same challenges as you. Even if it’s through a compliance training group like the one we created on LinkedIn, sharing common experiences, successes, and bumps in the road is a critical tool for navigating the morass of changing policy and priorities during the pandemic.

3. “Study the 2020 OIG Fraud Alert to identify the areas that are top of mind for government regulators moving forward.”

A cursory review of the special fraud alert released by the OIG last November reveals nothing revelatory or surprising in terms of the fraud and abuse risks related to speaker programs. Rather, as was noted during the webinar, the importance of the alert lies more in the mere fact that the agency released it. On page 3 of the document, the agency states “Our investigations have revealed that, often, HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” Anyone who has been paying attention to recent settlements is not shocked by such a statement but the language points to two of the areas the OIG considers to be of primary concern for compliance violations. Consider this special alert as a shot across the bow of the industry. The focus on the speaker programs isn’t going away anytime soon, and now is the time to make sure your policy and training targeting reps, presenters, and vendors is up to date and covers all the risk areas.   

4. “Trade show vendors have probably not thought through the potential compliance concerns of holding the meetings virtually. You need to be engaged with them about those details beforehand.”

Compliance training cannot end with employees, especially during a pandemic when the rules are constantly changing. When a vendor is organizing a trade show or conducting any business on behalf of the company, the risk grows exponentially. Are your trade show vendors aware of the rules and your policies regarding product promotion and scientific exchange? Have you fully considered the ramifications of building and delivering online training for vendors? Don’t assume that your vendors are going to take the same diligent approach to compliance as you do and don’t just hope they stay abreast of the latest best practices around virtual communication. If you launched vendor training prior to the pandemic, consider adding microlearning refresher training to highlight changes in policy.

5. “Utilize a campaign approach to training to support branding efforts and make the concepts more memorable.”

The session titled, “Training – Best Practices for Promotional Compliance challenges in a Virtual World, Creative Solutions to Keep Sales Reps from Going Off the Guardrails” offered a range of tips for changing behavior through core training, performance support, and reinforcement training (I know, I’m biased because the co-presenter was my colleague, Dan O’Connor, but you really should see this slide deck). No matter your budget, rolling out branded components across a learner’s timeline, rather than launching one large bolus of content, has been proven to enhance learning and increase the retention of that content. The “Forgetting Curve” is real, and if you want to make your training more memorable, you need to make it continuous.

All the presentations during the Biopharma and Biotech Corporate Compliance Summit offered enough nuanced twists on familiar topics to make a one-day commitment of time worthwhile. The last year has seen an upheaval in how the industry conducts business, which has resulted in a sudden need for changes to compliance practices and policies. Even with established organizations like PCF and Informa Connect continuing to keep their own events timely and relevant, there is always room for another player. Welcome to the party, KNEX.

Thanks for reading!

Sean Murphy
PharmaCertify

Ten Training Takeaways from the 21st Pharmaceutical and Medical Device Ethics and Compliance Congress

The Pharmaceutical Compliance Forum (PCF) went to great lengths to replicate the experience of a live conference in this year’s virtual Pharmaceutical and Medical Device Ethics and Compliance Congress. The virtual conference platform featured presentation rooms and realistic exhibit halls that made navigating the user interface simple and logical.

Organizers took advantage of the virtual nature of the conference to maximize the amount of content available through live presentations, along with a plethora of recorded presentations available for viewing any time. In fact, if you attended the conference, the sessions will remain available to you for up to six months – so don’t be shy about logging back in and catching up on what you missed.

I’ve done just that over the last few weeks and in the spirit of the PharmaCertify mission to help you reduce risk and strengthen the compliance culture in your company, here are ten key conference takeaways to help you build a more effective training curriculum.

  1. Meals, meals, meals.
    How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.
  2. Remember the changes to the Sunshine Act.
    Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!
  3. Be aggressive.
    Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.
  4. Keep the communication flowing.
    An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.
  5. Patient support and speaker programs are still in focus.
    Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.
  6. Pay attention to social media.
    According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.
  7. Customize training for company-specific risk.
    I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.
  8. Emphasize a culture of integrity, not just compliance.
    Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?
  9. The core rules still apply.
    While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply,  and state disclosure laws need to be followed.
  10. More risk is okay if you have a strong foundation to manage that risk.
    Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.
  11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part 2: A Continued Focus on Speaker Programs and Patient Support Programs

This is the second in a series delving into compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Before the sudden changes brought on by COVID-19, speaker programs and patient support programs were two of the hottest topics in the industry and the pandemic has only heightened the concern. Through live presentations and on-demand sessions available throughout the conference, regulatory officials and industry representatives offered suggestions for managing the programs.

Speaker Programs

During the Enforcement Deep Dive and the DOJ and SEC Insights sessions, panelists reviewed the recent settlements and CIAs related to speaker programs. The cases mostly focused on what one presenter referred to as the “hallmark red flags” he and his colleagues look for in an investigation: repeat speakers and attendees, speakers who were high-prescribing HCPs, alcohol being served, and less than adequate attendance. Alleged violations in the settlements were based on everything from the inappropriate fees paid to speakers and improper promotional activities at the programs, to some companies paying speakers for programs that never occurred.

While regulators provided the groundwork related to traditional topics like speaker criteria and compensation, and attendee management, industry professionals shared tips for effectively managing the programs during a pandemic. In the session titled, Operational Considerations for Speaker Programs During a Pandemic, presenters offered a list of considerations such as updating training on tracking and reporting attendance; adding up to an hour of prep time so all participants have the opportunity to get comfortable with using the technology; and reviewing existing HCP contracts and adjusting provisions for travel since travel to the programs is not currently required.

Not surprisingly, the practicality of providing meals during the pandemic was raised throughout the conference. During the DOJ Enforcement Trends Related to Speaker Programs on-demand session, the challenges with documenting and tracking consumption were raised as a unique risk associated with virtual programs. For example, “ensuring attendees stay for the educational component of a program,” and “providing meals in a way that accounts for COVID-19 related health and safety issues” are suddenly necessary considerations.

Virtual speaker programs raise challenges the industry has not had to consider before the pandemic. Presenters offered an important reminder as to why diligence to how these programs are executed is more critical than ever, by reminding the audience that “government agencies have made it clear they will scrutinize conduct…companies should still comply with codes of conduct and government regulations. There is no COVID-19 defense.”

Patient Support Programs

On the patient support program front, the emphasis in investigations is on what one presenter called “good evidence of bad motivation.” As with speaker programs, the fundamental rules continue to apply. For example, the programs cannot be used to influence a provider’s or patient’s medical decisions and patient privacy must always be protected. Grants and donations to foundations cannot be driven by sales and marketing, or as one presenter put it, “the commercial side should never determine how much goes to foundations.”

With patient foundations being a focus in recent CIAs, presenters during the Enforcement Snapshot and Best Practices Related to PAPs, Coupons and Foundations session covered the important requirements established in those settlements, including the need for a governance committee that is solely responsible for activities related to copay foundations; the importance of establishing an annual budget for donations to foundations; the requirement that donations must be selected using a risk-based approach and random sampling; and the need to be aware of state limitations on copay assistance, such as Massachusetts and California not permitting assistance when a generic is available.

Presenters also pointed out that settlements involving patient support programs have changed for one significant reason: the foundations have also been targeted and have entered into agreements with the government. As one presenter put it, “that means the foundations have skin in the game. Gone are the days when manufacturers called all the shots around contributions to foundations, program design, and compliance controls.”

The requirements detailed in recent settlements point to the need for updated policies and practices, and subsequently, updated training around patient support programs. Not only does core training need to be modified, a new approach is needed to ensure pull through on the significant changes.

A New Approach to Training

Clearly, the fundamental rules related to speaker programs and patient support programs have not changed and still need to be addressed in training, as they were before the onset of the pandemic. speaker programs and patient support programs continue to be high-risk activities. When they are not managed properly, companies face the potential for off-label promotion, false claims, and Anti-Kickback Statute violations, to name just a few. But the nuances of how these programs are executed are now in flux and require serious consideration in terms of content updates and delivery modalities.

Foundational training remains an important starting point. Dedicated training on speaker programs should still include core topics such as program logistics, audience requirements, speaker compensation and training, and answering off-label questions. And patient support program courses must continue to focus on areas such as protecting patient privacy, working with vendors, and working with patient assistance foundations.

Clearly, COVID-19 requires changes to how both types of programs are planned and executed. To ensure targeted employees stay in compliance a supplemental approach towards reinforcement may be appropriate. For example, mini modules covering the provision of meals should be considered to stress the details of updated policies. In addition, microlearning components in the form of mini-assessments, videos, and podcasts are a valuable way to increase the retention of new and updated policies as well as the foundational topics. And custom scenario-based training is an ideal format for highlighting aspects of policies that are particularly relevant to conducting these programs during the pandemic.

Increasing the retention of compliance training is more challenging than ever given the changes in which your field staff and other employees conduct business. The information shared during the Pharmaceutical Compliance Conference serves as a reminder that speaker programs and patient support programs continue to be high areas for risk and a focus of investigations. The onset of COVID-19 has complicated that risk by forcing the industry to rethink how the programs are managed and how employees are trained on the details. Creating a continuous training curriculum, with new microlearning components integrated across learners’ timelines, is critically important to ensuring those details are not lost while understanding that the potential for violations are increased.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Up Next: Enhancing Training Engagement in a Changing Industry and World

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part I: A Conference Overview and What It All Means for Your Training

State of the Art Compliance Training, with Dan O’Connor of PharmaCertify, was just one of the 14 on-demand sessions at PCC2020.

Welcome to the first in this multi-part series based on CBI’s recent Pharmaceutical Compliance Congress! For obvious reasons, the conference went virtual this year, yet it offered an impressive lineup of industry professionals, vendors, and government officials offering compelling tips and guidelines for building and maintaining an effective compliance program in the life sciences industry. In addition to the live presentations, organizers offered 14 “on-demand” presentations covering an impressive array of topics, so from a content perspective, the virtual format created even more opportunities for learning.

Over the next month, I will touch on some of the thoughts shared by presenters related to topics like speaker programs, patient programs, risk assessments, third-parties, patient advocacy groups, transparency, and strategies for field team compliance, to name a few. And since the mission of this blog, and the PharmaCertify team, is to help you reduce risk and strengthen your compliance culture through training, I will include suggestions for growing and modifying your compliance training practices and curriculum in response to the information shared during the conference.

Kudos to the team at CBI/Informa for their diligent efforts to replicate the learning and networking experience of the live conference. PCC 2020 was a busy conference, with an impressive volume of content scheduled throughout the week and in the on-demand sessions. If you attended and did not have the opportunity to review the on-demand sessions, I have been told these will remain available until September 14th. You will especially want to review the State-of-the-Art Compliance Training session, where my colleague Dan O’Connor and compliance professionals from Sage Therapeutics, Regeneron, and Akebia Therapeutics share creative approaches for increasing training engagement and adoption. You don’t want to miss that one!

While some of the topics were familiar to anyone who has attended the conference in recent years, the “elephant in the room” was not ignored, as a multitude of presenters addressed the overwhelming challenges of keeping an entire organization focused on conducting business in a compliant manner during these unprecedented times. The result was an interesting blend of traditional and familiar compliance conference topics and guidance on navigating the risk associated with conducting business in a highly regulated industry during a pandemic, or at least as much guidance as can be expected at this time.

From a high-level training standpoint, the presentations at the conference affirm the need for a more dynamic and blended curriculum, with microlearning and other components delivered across your learners’ timelines. The method by which life sciences employees conduct their daily activities has suddenly changed, and the level of risk and potential for violations has grown exponentially with that shift.

One of the more compelling presentations was the “Criticality of Compliance” session with John Crowley of Amicus Therapeutics. John shared his family’s moving story and his incredible journey as he pushed for the development of a product to help his two children (did you know his story was the basis for the feature film, Extraordinary Measures?). As he spoke, John reflected on what the commitment means to the patients battling the rare diseases his company’s products treat, “as life sciences professionals, we are an extension of the oath that doctors and nurses have taken, and it is a solemn oath,” he said, “if there is a compliance violation, everything we hoped for in the next several years is threatened.” It is a laudable approach to building a culture of compliance at Amicus and one worthy of emulation.

I look forward to sharing more ideas from the conference, as well as subsequent training suggestions you can utilize to strive toward similar ideals and goals in your organization.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Coming Up: Speaker Programs and Patient Support Programs