Lessons Learned at the 19th Annual Pharmaceutical and Medical Device Compliance Congress

Lesson 2: The More Things Change…

Tessa Hoyer of PharmaCertify greets attendees at the 19th Annual Pharmaceutical and Medical Device Compliance Congress.

The French journalist and novelist, Jean-Baptiste Alphonse Karr, is credited with coining the phrase, “the more things change, the more they stay the same.” For anyone who has attended multiple compliance conferences in the last five years, his words certainly ring true. Terms like “partnering with the business,” “tone from the top,” and “third-party risks” are still staples during conference presentations and this year’s Pharmaceutical and Medical Device Compliance Congress was no exception. For good reason.

As an example, the Compliance 3.0 presentation on Day 2 of the conference began with one panelist expressing his concern that “we still have to fight for a seat at the table.” In other words, while the concept has been bandied about for years now, the reality is that raising compliance to the organizational level of respect it requires to affect true behavior change is still a struggle. He and his co-presenters emphasized the need to not only find that seat alongside the businesses but truly understand their business policies as well as what they do and who they are. As another presenter put it, “bring value to the business as a compliance representative, educate them every step of the way, and help them educate their people.” She added, “when they get to the point where they are doing it themselves, that’s nirvana.”

Not surprisingly, the need to train and manage third-party vendors continues to be stressed. In the session covering the Foreign Corrupt Practices Act, one government representative even delved into the need to extend the corporation’s culture to the vendors. She added “you really need to know your third-party vendors and they need to understand you. You need to know who it is that is making payments on your behalf.” The presenters in the Third-Party Lifecycle Management session agreed, citing the need to “have vendors take the same training that is rolled out for your employees. Treat them as partners and make sure they understand the risks involved.  They are more likely to care about being compliant if they feel like a partner and if they will be held responsible.”

As with the conversation and debate over an “ethics-based approach to compliance,” concepts like “tone from the top,” “partnering with the business,” and “third-party risks” warrant our focus and consideration simply because they are that relevant and critical. Industry conferences offer the valuable opportunity to hear our peers share their latest insights and success stories around the themes that seem to drive the conversation. While the world of life sciences compliance is evolving, in some cases, the more things change, the more they stay the same…at least at the compliance conferences.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Intelligence Blog

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!

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

“Dear Connie the Compliance Training Specialist” Debuts on the PharmaCertify Blog!

Welcome to the inaugural edition of “Dear Connie the Compliance Training Specialist,” where we answers questions about timely compliance topics and delve into the best training methods to reduce the risks.  

This week: managing the potential perils of speaker programs

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Dear Connie,

I am a compliance manager for a small pharmaceutical company in the Northeast. I am concerned that our new sales representatives may assume that they don’t need to worry about the details on speaker programs since an outside vendor manages them for us. We touch on speaker programs in the initial training all representatives take, but I am not sure we emphasized their responsibilities enough. Am I crazy to be concerned?

Signed,

Concerned in Connecticut

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Dear Concerned,

First, you are not crazy and I understand your concern. Speaker programs are a hotbed for potential compliance risks. It has been my experience that if you roll out additional training, like microlearning, assessments, and contests continuously to the reps, you’ll significantly reduce the risk around speaker programs.

Here are just a few topics to keep top-of-mind for the reps, and cover in the continuous training, even when an outside vendor is managing the program for you.

Attending to Attendees Concerns

On-going training needs to emphasize the finer details involving attendance. Representatives need to know that transparency laws require attendance to be documented, and it also helps the company evaluate the program. Whether a meal is offered or not, all attendees must sign-in. Reps need to remember no-shows and those who refuse a meal must be documented.

Speaker programs typically have a minimum required number of attendees. If the RSVPs fall short of that number, the program should be cancelled. Verbal commitments do not count.

Off-label Questions

Off-label questions asked during the presentation are another area of concern. If your company allows speakers to answer off-label questions (not all companies do), the speaker needs to make attendees aware that the question is in reference to an off-label use, and answer only the question that is asked. If that doesn’t happen, the sales representative must interrupt the speaker. Otherwise, the company can be accused of promoting the product for the off-label use. This is a great topic for role-playing during live training.

In addition, physician speakers represent the company. The programs are promotional in nature, so representatives must follow FDA regulations and speakers must follow the approved program. They may not proactively share their experience involving unapproved uses of products.

Speaker Requirements and Issues

I remember one case when a speaker unavoidably arrived late due to traffic and he suggested that he skip several slides to catch up on the time. Make sure the representative knows to stand firm on this. All slides must be delivered.

Another time, the representative realized, after the presentation started, that the speaker added his own slides to the deck. Representatives need to be trained to not panic and cause a disruption, but make note of the incident and notify a manager and the compliance department about the incident. Representatives should remind speakers that in the future, only the approved slides may be used.

Speakers sometimes ask if they can bring additional material about the topic being discussed, to hand out to the attendees. Representatives need to be trained to always let the speaker know that all materials must be approved by their company in advance of the program – whether the request occurs prior to the program or when the speaker arrives. Unapproved handouts are not permitted.

Thank you for a great question!

Connie the Compliance Training Specialist

Kicking Out Kickbacks in the Medical Device Industry

The federal Anti-Kickback Statute prohibits the exchange of anything of value to induce or reward the referral of federal health care program business. Business processes that are perfectly legitimate in other industries, like entertaining clients, or providing gifts to prospects, can be tricky in the medical device industry. Identifying the activities hold the potential to implicate the Anti-Kickback Statute is key to reducing risk across a medical device company.

Here are five areas to evaluate for risk:

Device Loaners/Evaluation Units
Device loaners and evaluation units are big risks. Be sure to provide only as many units as needed for evaluation, and for no longer than is necessary for the evaluation. If the loaner is provided to temporarily replace a broken unit, make sure the loan period does not continue past the time necessary to complete the service work.

Pricing Discounts
Pricing discounts require a level of transparency on the part of the seller and the buyer. Purchase agreements must clearly disclose the discount, and purchasers should be advised in writing that they too need to disclose the discount when they submit information to federal healthcare programs for reimbursement.

Gifts, Meals, Travel
Providing meals, gifts, travel and hospitality to an individual who is in a position to purchase, or recommend the use of a product, is risky. Gifts that do not have an educational benefit for the recipient or patients are particularly problematic.

When a gift is provided, the value should be nominal and cash or cash equivalents are never appropriate. Avoid lavish meals, and make sure meals occur in locations that are conducive to holding a business, educational, or scientific discussion. Finally, do not provide lavish travel or hospitality for company training or meetings.

Consulting Agreements
Remember to establish the objectives for consulting engagements with healthcare professionals (HCPs) prior to the start of the business relationship and only use as many consultants as needed to achieve the objectives. Timelines need to be included in the agreement and the consultants must be compensated at fair market value. The consulting relationship needs to be disclosed during the program.

Grants and Donations
Establish processes to objectively evaluate requests for grants and donations. Support should not be awarded to induce or reward the purchase or recommendation of product. Support of educational grants should not be contingent on the ability to select faculty or determine content of the program.

Medical Device Anti-Kickback Training
Our Compliance Foundations medical device eLearning modules cover critical topics such as the Anti-Kickback Statute, interactions with healthcare professionals, transparency, and speaker programs. Course titles include The AdvaMed Code; Global Anticorruption Laws; Medical Device Compliance Overview; and On-label Promotion. To see a demo and learn more, please contact Dan O’Connor at doconnor@nxlevelsolutions.com or 609-483-6875.

Thanks for reading!

Lauren Barnett, Senior Compliance Specialist

Compliance Trends 2018: Our Point of View

The festivities have ended and a shiny new year is upon us, so we are switching hats – from party to prognostication – to delve into what we see as the hot compliance topics and trends for 2018. Based on our reading of the enforcement tea leaves, several 2017 topics should remain at the forefront, but our prediction on the level of activity emanating from the OPDP has changed from last year. So if you’ve resolved to stay up-to-date on all the compliance news fit to blog this year, what better way to start than with this look ahead.

We expect funding for patient assistance organizations, which are charities that provide financial assistance to patients to help cover the cost of medications, to be a trending topic in 2018. In 2016, federal agencies started to focus on the topic and issued subpoenas related to support provided to these charities. In 2017, two companies entered into settlements with the government over that funding. The government considers the practice to be a violation of the Anti-Kickback Statute because the funding offsets the co-pay of patients who participate in government healthcare programs.

Donations to charities that assist with medication costs are permitted, but assistance cannot be directed to patients who are prescribed the donating company’s medications. We would not be surprised to see the government take more of an interest in the financial relationship between the industry and charitable patient organizations this year. Training must emphasize the need to maintain appropriate independence between the company and the patient organizations it chooses to support.

In 2017, a small group of states passed laws related to price reporting, sales representative registration, and physician payment caps. That trend should continue in 2018 and the laws will most likely be focused on pricing transparency, as opposed to spend transparency, which was more common a few years ago. Expect more states to follow New Jersey’s lead and implement broader restrictions and caps on payments to healthcare professionals. The law is intended to combat the growing opioid addiction crisis.

2017 was a surprising year for the Office of Prescription Drug Promotion (OPDP). After a flurry of letters at the end of 2016, we expected the agency to continue that trend into 2017, but only four letters were issued the entire year. That is a record low. Don’t expect a dramatic increase this year.

The letters that were issued last year were focused on false and misleading statements related to risk and omission of risk. Two industry settlements in 2017 included charges of failure to disclose risk in violation of the Risk Evaluation and Mitigation Strategy, so emphasizing the importance of fair balance and truthful, accurate promotional statements when training sales representatives is critical.

On the global front, we would not be surprised to see an uptick in Foreign Corrupt Practices Act enforcement following the implementation of new processes that reward companies for self-disclosing potential violations and cooperating with investigations.

With that, we end this “preview” edition of the Compliance News in Review. To be automatically notified when we post new editions of the News in Review, conference highlights, or compliance training tips, just click the “follow” button on the right side of this page.

Have a safe and compliant 2018!

The 2017 Compliance Year in Review!

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!