“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

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 Do’s and Don’ts of Compliant Product Promotion

In keeping with our mission of helping you reduce risk and strengthen your compliance culture, we present our top do’s and don’ts for promoting products to healthcare professionals:

  1. Do…be balanced and accurate! Present the benefits and the risks of a product equally.
    Don’t…omit or minimize the risks associated with the use of a product, or exaggerate its effectiveness.
  2. Do…stay on-label! All promotional statements about a product must adhere to the product label.
    Don’t…promote any off-label uses of a product.
  3. Do…use approved promotional materials! Use promotional materials provided and approved by the company to promote a product.
    Don’t…Use retired promotional materials or create your own materials to promote a product. Do not add logos, names or other product information to candies, cookies, or other items, without prior approval.
  4. Do…be careful about comparisons! Only share competing product information that has been approved by the company.
    Don’t…Make unsubstantiated comparative claims about a competitor’s product.
  5. Do…spread the knowledge! Share approved scientific publications or journal reprints with healthcare professionals.
    Don’t…alter any approved publications before you share them with the approved audience.

Thanks for reading!

Compliance News in Review, December 12, 2016

If you’re dancing “The Beagle,” and you can’t break away from all of the movies starring Candace Cameron Bure on the Hallmark Channel, it can only mean one thing; it’s Christmas time! Despite what Staples would have you believe, THIS is the Most Wonderful Time of the Year. Before you fill your heads with dreams of sugarplums, we have a quick yuletide tale to share. Gather round friends to hear the tome; our newsy, Compliance News in Review Christmas poem.

T’was the News before Christmas, and all through the land,

Our readers waited for the first story at hand.

The story was chosen with the utmost of care,

In the hopes of bringing joy and not causing despair.

In Congress a healthcare bill was just passed,

But not without a change that left some hopes dashed.

Despite efforts to exempt, companies will still report

Payments for textbooks, reprints and speaking fees of a sort.

Senators exclaimed the payments we must heed

With the exemption removed, the bill passed with ease.

With the healthcare bill passed and well on its way,

We will move on to news from Californ-i-a.

Away went a bill in the last governing session,

Requiring disclosure of drug pricing information.

Not one to give up, an intrepid senator said,

“I’ll make minor changes. This bill is not dead!”

Change his bill he did, and returned it to the floor.

Companies must report price hikes of 25% or more. (if passed)

Then over at Teva there arose such a clatter!

We wondered out loud what could be the matter?

After one bribery investigation and setting aside cash

A tip came in – to Romania Teva should dash!

Bribes of travel and consulting fees were paid.

Teva is investigating all of these claims.

On the “nice” list of St. Nick we all hope to be,

But this group of execs will be found on “naughty.”

Six from Insys were arrested for inducements

Paid to docs to write scripts for unapproved uses.

The former CEO is one of the six, yes really.

His lawyer exclaimed he would plead “not guilty.”

Others in trouble are from marketing and sales.

Don’t buy the business is the moral of this tale.

With that last story our tale must come to an end.

We’ve enjoyed sharing it with you our dear friends.

So until we return with more news and insights,

Merry Christmas to all, and to all a good night!

Compliance News in Review, August 19, 2016

The Pfizer shareholder suit settlement, Open Payments Open Forum, Robert Callif addresses sharing truthful off-label information, a whistleblower suit, and it’s always Sunshiney in Germany in this edition of the Compliance News in Review.

Dum, dum, da, dum, dum, dum, dum. Dum dum da dum dum dum dum da dum dum dum dum. No doubt you recognized that familiar melody as “Bugler’s Dream” (a.k.a., the Olympic theme). The games in Rio are in full effect! If you’re like us, you’re suffering from sleep deprivation from all the hours of late night coverage. Fear not, we haven’t completely forgone compliance news in favor of sport. Take your mark, because we’re about to start this edition of the Compliance News in Review.

Pfizer is setting aside $486 million in “gold medals” to resolve the shareholder suit over concealing the safety risks of Bextra and Celebrex. The settlement is pending approval of the shareholders, and if approved, will end 11 years of litigation.

Open Payments is back on the track and poised for changes. In July, CMS posed several questions in the proposed 2017 Physician Fee schedule. The agency held an Open Door Forum for Open Payment stakeholders to provide responses to these questions. Much of the discussion focused on the reporting and reviewing of information related to teaching hospitals and whether to increase the number of payment categories. Other topics included pre-vetting data; the review and dispute process; and whether user accounts for physicians can be structured so they don’t expire after six months of inactivity.

A whistleblower claims Celgene isn’t playing the game fairly. A suit filed by a former company sales rep claims the company made donations in order to drive product sales. The suit claims the company made donations and then worked with the charities to assure that the majority of the funds were directed to patients who were using Celgene drugs. Celgene says the claims are baseless and the federal rules regarding donations were followed.

FDA chief Robert Califf spent time hurdling the issue of sharing of truthful off-label information at the recent BIO conference. In his remarks, Mr. Califf said scientifically supported information worth sharing should be on the product’s label, and that there is a responsibility to share use information gleaned through the clinical trial process and it’s reasonable to expect that information to be part of the product’s label. He noted that publicly available information that is not part of the label is trickier, and that the agency was “working on it.”

The score from the German judge is…575 million. According to the German news magazine Spiegel, payments made to German HCPs and HCOs totaled 575 million euro in 2015. The country made the data public in a searchable database following a suggestion by EFPIA. The magazine noted problems with the data being incomplete and inaccurate, and only 75% of pharmaceutical companies were represented. It called for the German government to consider legislation similar to the Sunshine Act in order to implement true transparency.

Well, we need to get back to the thousands of hours of streaming coverage – bring on the table tennis – so we’ll end this edition of the Compliance News in Review here. Enjoy the rest of the Games everyone, and stay compliant.

To Use Employees as Actors for Compliance Training or Not: That is the Question

Shakespeare said, “All the world’s a stage,” but when that stage is your training video, should your colleagues be the players? Before taking the leap and giving employees their “fifteen minutes,” you need to weigh the advantages and disadvantages and determine how each approach could help or hurt the effectiveness of your compliance curriculum. At PharmaCertify™, we have differing opinions based on first-hand experiences developing compliance training and corporate video programs. Here’s where two of us landed.

The Case for Using Employees as Actors
Lauren Barnett, Compliance Content Specialist

One obvious reason to use employees in your compliance training is the cost. Actors, even non-union ones, are expensive. Depending on the level of the skill the actor brings to the table, the cost of talent can be one of the top expenses in your video. A video shoot can last anywhere from a few hours to a few days, depending on the requirements of your project, so using the “free labor” you have at your fingertips can have a significant impact on the overall cost of the project.

Businesses and industries often have their own jargon. Add the medical or product-specific lingo that may need to be included in the training, and understanding the script for your compliance video could be like learning a new language. Your colleagues will be more authentic when delivering jargon-laden lines on camera. Actors won’t have the contextual experience with the language to deliver lines naturally or with confidence. Your learners do have familiarity with the language and they’ll notice when the actors aren’t comfortable and the learning will suffer.

Finally, using employees from the compliance department, or other departments the learners only interact with on a remote level, humanizes those departments and has the potential to build a stronger rapport between compliance and the rest of the company. Too often, the compliance department is seen in a negative light, or as the “police,” who are just waiting for employees to do something wrong. A truly effective compliance training curriculum addresses that concern, and includes components designed to portray those responsible for policy and training as partners who are there to support, encourage and inform. Using team members as actors in the compliance training is one major step toward that goal.

The Case Against Using Employees as Actors
Sean Murphy, Product and Marketing Manager

You may see your coworkers as free talent, but they aren’t professional talent. Acting is an art and a skill, and the fact an employee “was in a play in high school,” doesn’t necessarily mean that colleague is a trained actor. Good actors, even those working in local theater, have typically trained for years in their craft. You might get lucky and have a gem or two in your free talent pool, but when you use someone who is not comfortable or experienced, you run the risk of the key messages being lost behind the bad acting.

You also have to consider the cost to the business in lost productivity when employees are spending their time trying to convincingly read lines. Video shoots are time-consuming (especially when multiple takes are required because the actors are not professionals) and often require the actors to be “on set” for a number of hours. When your colleagues are pulled away from their jobs for that extended period of time, others may have to do their work, or they will at least have to book extra hours to make up the work they missed.

Finally, yes, employees can add an air of authenticity to your video, but it comes with the risk of your learners focusing on the fact they are watching “Bill from Marketing” in a video. Your key training messages may be lost because the learner’s attention is focused on the fact that is “Bill from Marketing,” instead of the subject matter. Additionally, if the audience includes vendors, they won’t know Bill, so he’s just another actor for them, so any authenticity is lost, and if Bill isn’t a good actor, he’s now a distraction as well.

What’s Your Verdict?

Using colleagues as actors can add an element of authenticity and fun to your training videos and can certainly help with the budget department. Before moving ahead in casting colleagues, it is important to consider the training goals of the video and determine if using colleagues will serve those goals or will simply be a distraction.

Now, we want to know what you think. Have you tried using your coworkers as actors in your compliance training? Did it work well? What were the pitfalls? Do you agree with Lauren or Sean? Who gets the bragging rights this time? Contact Sean at smurphy@nxlevelsolutions.com to let us know.