OIG

Training Takeaways from the OIG Update at the PCF Compliance Congress

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For life science compliance professionals, one message came through clearly during Mary Riordan’s Annual OIG Update at the 27th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress: Compliance programs are under increasing pressure as challenges grow and government expectations rise.

Ms. Riordan, Senior Counsel with the OIG, covered recent enforcement actions, Corporate Integrity Agreements (CIAs), compliance guidance, and areas receiving increased scrutiny.

Across those topics, a common theme emerged: effective compliance requires active monitoring, strong governance, relevant training, and a willingness to look beyond the usual risk areas.

Following is NXLevel Compliance’s synopsis of key messages, with an emphasis on potential implications for compliance training.

Compliance Risks Aren’t Limited to Sales

Kickbacks continue to be a major focus, with recent enforcement actions involving specialty pharmacies, patient assistance foundations, speaker programs, consulting arrangements, meals, travel, and other HCP interactions.

But compliance teams also need to think more broadly about who creates risk.

Recent CIAs have expanded the focus from traditional sales representatives to “field personnel,” including other employees who also interact with HCPs, healthcare organizations, and formulary decision-makers. A recent settlement between DOJ and Veloxis, for example, included alleged misconduct involving Market Access activities.

For compliance training, that’s an important reminder. Training shouldn’t be one-size-fits-all or focused primarily on sales. Market Access and other field-based teams encounter different compliance situations and need training tailored to those real-world risks.

Policies Are Only the Starting Point

Ms. Riordan highlighted recent enforcement cases that show what can happen when companies have rules, but employees find ways around them.

They included examples of employees manipulating expense reports to stay within meal limits, paying for inappropriate travel and entertainment, and paying consulting invoices for work that wasn’t performed.

That’s why monitoring matters. Compliance teams need to look at everything from HCP call notes and electronic communications to consulting agreements, advisory board records, meals, and travel. Field ride-alongs can provide an additional window into what’s really happening.

Training can be another important part of that equation. Rather than simply explaining policies and spending limits, effective training can put employees into realistic scenarios and challenge them to recognize the risks, make the right decisions, and know when to ask for help.

Just as importantly, monitoring results can help inform future training. If audits or field monitoring uncover recurring areas of confusion, those findings can become the basis for targeted education and reinforcement.

AI Is Joining the Compliance Conversation

Generative AI is also showing up in recent CIAs. Organizations and Independent Review Organizations may be required to disclose certain uses of generative AI and independently verify the accuracy of AI-generated output.

Even for companies that aren’t operating under a CIA, there’s a useful takeaway: employees using AI need to understand the related compliance expectations, including the importance of human review and accountability.

Compliance Needs a Seat at the Table

The OIG is also continuing to emphasize compliance independence and authority. Principles from its 2023 General Compliance Program Guidance are appearing in newer CIAs, reinforcing expectations around direct access to senior leadership and boards, compliance officer independence, and meaningful oversight by compliance committees and directors.

That same philosophy applies to training. Training shouldn’t exist simply to check an annual requirement off the list. It should support the risks the compliance program is actually identifying and help employees put policies into practice.

From Knowing the Rules to Applying Them

Perhaps the biggest takeaway from the OIG update is that effective compliance is increasingly concerned about what happens in the real world.

Policies and training provide the foundation, but organizations should be asking deeper questions: Does our training reflect the situations employees actually encounter? Are we reaching all the people who create or manage compliance risk? Can employees recognize a problem when there isn’t an obvious right answer?

Ultimately, good compliance training should help people recognize risk and make better decisions when it counts.

Thanks for reading!

-Paul Nash

pnash@nxlevelsolutions.com

NXLevel Compliance

Training Highlights from the OIG’s New General Compliance Program Guidance

NXLevel Compliance Team , , , ,

Like many of you, we’ve been reading the new General Compliance Program Guidance the OIG released this week. And of course, we jumped right to the section on training! Before we discuss the OIG’s new training guidance, we should note that this guidance applies to the healthcare industry as a whole, not pharmaceutical manufacturers specifically. However, the OIG has announced its intent to continue to publish separate guidelines for specific industry sectors and we can expect to see new and revised versions of those guidelines in the future.

With that caveat in mind, how does the training guidance in the OIG’s new General Compliance Program Guidance compare to what’s stated in the OIG’s existing Compliance Program Guidance for Pharmaceutical Manufacturers? Essentially, the message is the same, but there are new points of emphasis.

One of the most striking statements in the new guidance is, “Education should not be limited to annual formal training requirements. The compliance officer should seek and develop opportunities to provide education on compliance topics and risks throughout the year.”

This follows a trend many companies have already embraced. More companies are supplementing their formal compliance training events with micro-modules, short videos, brief communications, games, quick reference guides, and other less formal solutions that are deployed over the course of the year. The result is a learning ecosystem designed to reinforce and reenergize key compliance behaviors and messages. The OIG guidance calls out examples such as those mentioned above.

Other new points in the guidance jump out as well. The document:

  • Explicitly states that compliance officers should develop annual training plans that include the training topics to be delivered and the target audience for each topic
  • Provides a list of suggested topics to cover when training employees on your company’s compliance program
  • Emphasizes the need to provide targeted compliance training to board members
  • Stresses that compliance training should be made accessible to all learners (for example, by making it available in different languages)
  • Provides guidance on allowing training waivers for contractors

Obviously, there’s more than just training guidance to be found in the OIG’s new document, and we’ll be combing over it looking for more nuggets to share here and on the NXLevel Compliance LinkedIn page. In the meantime, feel free to reach out to info@nxlevelsolutions.com to learn how we can help you reduce risk and be a compliance hero!

Compliance News in Review, June 29, 2015

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The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.

PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.

The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.

The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.

FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.

Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.

Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.

All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.

That’s the news for this edition. Stay cool and have a great week everyone!

Compliance News in Review, June 5, 2015

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Cephalon settles a generics case with the FTC over its sleep disorder drug and the OIG releases its mid-year update to its 2015 Work Plan, and we offer our take on how it impacts training.

Well, the summer blockbuster season is almost here. Superheroes, Sundance darlings, reboots and rom-coms will all be competing for our attention and discretionary dollars (is that a contradiction in terms?). While it may not carry the cache of the newest Clooney or Cruise release, we proudly offer our own little feature for your entertainment and edification…the latest edition of the Compliance News in Review. On with the show!

It’s finally a wrap on the Federal Trade Commission’s case against Cephalon. The FTC settled its pay for delay case with the company (now part of Teva) for $1.2 billion. The case involved Cephalon’s attempts to delay entry of generics for its sleep disorder drug. The settlement is the largest ever secured by the FTC.

The OIG has premiered its mid-year update to its Fiscal 2015 Work Plan. The update includes several new items, one of which is a review of the financial interests reported via Open Payments.

“We will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program. We will also determine the extent to which CMS oversees manufacturers’ and group purchasing organizations’ (GPOs’) compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.”

The OIG’s report on its findings is expected during fiscal year 2016. As Policy and Medicine points out, it will be interesting to see what sort of enforcement follows the OIG’s review, and if the information is used by the agency for its other activities involving fraud and abuse. This potential for enforcement involving this data should not be overlooked.

The first full calendar year of data has not even been released to the public yet, and the OIG is jumping right into a review. The agency’s actions underscore the importance of accurate data and the need for training to ensure that accuracy. From those engaging in transactions with covered entities, to those responsible for the reporting on the back end, understanding data collection and reporting requirements is critical. In addition to in-house staff, third-party vendors and partners that may be involved in reportable transactions on a company’s behalf need training on the basic requirements of the Sunshine Act and Open Payments.

Enjoy the weekend everyone, and we’ll see ya at the movies!