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To say the audience at the 19th Life Sciences Compliance Congress West was energized and engaged is an understatement. The size and scope of the two-day conference led to unusually interactive discussions, with the audience eagerly sharing their experiences along with the presenters and panelists. For someone relatively new to the field of life sciences compliance training, I found the exchange of ideas and advice quite educational and enlightening.
PharmaCertify was there as a conference sponsor and we found an agenda filled with information designed to help attendees strengthen their compliance cultures and reduce risk, which of course is a mission close to our hearts from a compliance training standpoint. Here are my takeaways, with a focus on training of course (it’s what we do):
1. Build an ethical culture, not just a compliant one.
This was a recurring theme, and it’s a compelling one. On the surface, the line between ethics and compliance may appear inconsequential and not significant enough to be worthy of consideration. But more companies are evolving away from a rules-based approach to compliance to one that stresses ethical decision making as the foundation for their principle-based policies. It begins with a question: are people doing the right thing when no one is looking?
For us, the answer begins with a new approach to training. Modern life sciences companies need to teach the value of ethical decision making, and not just recite the rules and regulations. Training needs to instill in learners the understanding that the company trusts and expects them to do just that.
2. Hubs are in, so get that training out!
Patient support hubs are trending, and since they serve as the “connection point” for so many stakeholders (patients, providers, and physicians), they come with a high level of risk. With the influence of commercialized companies, and the lack of guidance from the Office of Inspector General and Department of Justice, patient support hubs are a hot bed of kickback and false claims risks.
Job aids, clear business rules and program guidance, and a robust training curriculum are necessary to mitigate that risk. All parties involved, including vendors, must be continuously trained on how to interact with patients and understand what they can or cannot say and do.
3. If you think PSPs and PAPs are in the regulatory spotlight, you’re right.
The scrutiny on Patient Support Programs (PSPs) and Patient Assistance Programs (PAPs) is intensifying, with a growing number of settlements (Jazz Pharmaceuticals, United Therapeutics) raising questions over the idea of companies donating to independent charities. In addition to causing potential false claims and HIPAA violations, the donations raise concerns that they may be intended to induce patients to purchase certain products and implicate the Anti-Kickback Statute.
As was highlighted during the conference, PSPs and PAPs can be beneficial to patients, but commercial organizations cannot have any influence on the support being provided. Training needs to emphasize that sales representatives are not permitted to discuss specific PAPs or disease state funds with patients or healthcare professionals. And as prescription costs climb, the scrutiny and risks will continue to grow.
4. Nurse Educators: Are they here to stay?
The jury is still out. As defined during the presentation on nurse educators, “white coat marketing” refers to the use of healthcare professionals in marketing or sales activity, and therein lies the risk with the use of nurse educators. According to the Office of Inspector General (OIG), the practice is scrutinized under the Anti-Kickback Statute because patients rely on the advice of physicians, they may “have difficulty distinguishing between medical advice and a commercial sales pitch.”
Recently unsealed qui tam cases highlight the risks and cause for concern, with one company deploying “nurse ambassadors” directly to patients’ homes and another implementing nurse-led adherence programs designed to increase product refills. Patients tend to trust the opinion and advice of their physician, and by extension, their nurse educator. However, it can be confusing for a patient to decipher advice from marketing, and exposure points emerge when nurse educators are trained similarly to sales representatives and conducting calls with those representatives. Asking yourself key questions about the training:
- What materials do the nurse educators use (disease state, promotional, fair, balanced, etc.)?
- Does the training focus on adherence and education instead of sales and marketing?
- Does the training resemble sales training (e.g., overcoming objections, cold calling)?
5. Speaker Programs: How is this still happening?
The idea that speaker programs bring high levels of risk is not a secret, so much so that one audience member even asked, “how is this (insert expletive) still happening?” Good question. Selling in the life sciences industry is a relationship-based activity, and back in the “good old days,” there was little monitoring around meals, vacations, golf outings, etc. Now, the risks are rampant and include speaker selection (make sure they are credible), payments, receipts, the amount of money spent, spouses or guests in attendance, and analytics. The panelists also used Insys as a case study for the importance of communication, particularly email. Multiple documented emails within the company revealed how they were trying to utilize speakers. Training needs to emphasize the need for open, honest and communication, with no hidden agendas because as was quoted about the Insys case, “it takes a very long time to turn your ship around.”
6. Calibrate Your Compliance Training for Greater Impact
There’s plenty of guidance available from the DOJ and OIG to assist ethics and compliance professionals with determining their training priorities. The OIG guidance alone offers 49 distinct metrics for communication, education, and training. It can be a bit overwhelming, so what’s a compliance officer to do?
A presentation by Dan O’Connor of NXLevel and Jeremy Lutsky of Theravance offered attendees a practical framework for designing, developing, and implementing compliance training, beginning with the questions, “Is there a training need?” In other words, is there actually a knowledge and/or skill deficit or is there a problem with incentives, motivation, unclear expectations, etc.?
Assuming there is a training need, ethics and compliance officers can use the long-established ADDIE (Analysis-Design-Development-Implementation-Evaluation) process to efficiently attack the problem, beginning with analyzing risk by role in the organization. Several pragmatic approaches were shared by Dan and Jeremy, including use of the “3F” Curriculum Framework, Bloom’s Taxonomy, and a structured process for evaluating existing training.
7. The food choices in San Francisco are, well, pretty good.
The restaurant choices are clearly bountiful in the City by the Bay and we leave you today with a brief note on two that we enjoyed during our stay:
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The Hog Island Oyster Company is nestled in the Ferry Building Marketplace, where you can watch the ferries come and go as you enjoy freshly-shucked oysters on the half shell. Choose oysters from various locations or order a dozen or two to try them all! They all come with a fresh vinaigrette or cocktail sauce if you so desire. While their main stake is oysters, the rest of the menu is not neglected. The chowder comes stacked with clams in a nice cream base with veggies, potatoes, bacon and cheese! And the fish sliders are perfectly crispy paired with a tangy coleslaw that compliments the fish nicely. From the bar, the Chardonnay from Napa was crisp and light, and the Wolfback Ridge IPA was a perfect pairing for the fish sliders.
The Douglas Room is a quaint restaurant located adjacent to the Tilden Hotel that offers a boutique gastropub vibe to transport diners to another time (think speakeasy era). The talented mixologists curate creative spins on classic martinis behind the bar to help authenticate the experience. For dinner or late-night snacks, the innovative menu features locally sourced and seasonal ingredients. We enjoyed the shishito peppers, duck confit wings, wedge salad, and Tilden burger. The portions were perfect for sharing, and the presentation was stunning. We’ll be back when the conference returns to San Francisco!
Tessa Hoyer, PharmaCertify by NXLevel Solutions