“Dear Connie the Compliance Training Specialist” is back!

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

This week: raising knowledge retention at the next POA.

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Dear Connie,

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

Signed,

Bewildered in Bridgewater

Dear Bewildered,

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

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

Form Teams

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

Add Activities

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

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

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

Keep Score

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

Remember the Debrief

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

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

Thanks for the great question!

Connie the Compliance Training Specialist

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!

One company seeks to negotiate a settlement with the several states over opioid marketing, while Vermont investigates violations of its gift ban regulation…in this edition of Compliance News in Review.

Will Purdue Pharma go for the Hail Mary? Is Vermont about to throw a flag for gift ban violations? Is there a new way to offset bribery penalties? Will there be a third down push from the OPDP? We address these questions and more, in this edition of the Compliance News in Review.

In the words of Max from Where the Wild Things Are, “let the wild rumpus start.” No, not the holiday shopping frenzy (although that certainly applies), but the college football conference championships! Championship weekend is upon us and with it, the fight for a position in the playoffs. So far, the season has had its share of twists and turns, and the conference championships should provide additional drama. It all ends with the selection of the four playoff teams on December 3rd. To help fill the time to kickoff, we offer “X’s” and “O’s” of our own, in this edition of the Compliance News in Review.

Has Purdue Pharma huddled up with several state attorneys general? According to people familiar with the situation, the company has reached out to the states to gauge their interest in a global settlement related to its opioid drug. Currently, a consortium of 41 state attorneys general are investigating several opioid manufacturers’ marketing and sales practices. While Purdue is not authorized to represent other opioid makers, those familiar with the situation say the company is seeking an agreement that would cover all states’ lawsuits against all opioid manufacturers.

Vermont is calling for a review. The Vermont attorney general is investigating possible violations of the state’s gift to healthcare professionals ban according to a source familiar with the matter. The state law bans the provision of most items of value to healthcare providers. However, Open Payment data shows that physicians are receiving gifts, travel, and other banned transfers of value.

Companies that cooperate in FCPA investigations will now score big points with the Department of Justice. The agency will now consider foregoing criminal charges when a company self-reports. If a company cooperates with prosecutors, fixes the issue that led to the investigation, and helps investigators find the individuals responsible for the misconduct, the DOJ will presume the issue can be resolved without criminal charges. Any profits received from the misconduct will still need to be forfeited. Companies that do not voluntarily report possible FCPA violations may still be eligible for some leniency if they cooperate with investigators.

The Office of Prescription Drug Promotion has issued its third violation letter for 2017. A warning letter was issued to Amherst Pharmaceuticals and Magna Pharmaceuticals over promotional statements related to an insomnia drug. The OPDP cited false or misleading information about the risks and efficacy of the drug found on a product webpage and an exhibit panel. The letter also stated that the companies failed to submit the webpage and exhibit panels to the FDA prior to them being first used, as is required. Magna Pharmaceuticals says it will correct the exhibit panels and make sure all materials in the marketplace are correct. Amherst Pharmaceuticals was cited for information on the product webpage, but sold the insomnia drug to Magna in May.

With that news from the OPDP, the clock is winding down on this conference championship edition of the Compliance News in Review. If you’ve got a Dawg (how’s that for a hint as to who we will be pulling for?) in the fight in this weekend’s conference championships, we wish you luck (unless of course, your “Dawg” is a Tiger). Good luck to your favorite team or alma mater and we’ll see you here for the next edition.

Thanks for reading!

Open Payments Funding and Another Kickback Case in the News

An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

Life Sciences Compliance Congress West: A Preview

CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!