false claims act

Compliance News in Review, September 15, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

Illinois tackles illegal drug promotion by Insys; the ABPI calls out two member companies for breaking promotion rules; the Australian legislature shines a light on corporate crime and Medicines Australia reports on payments to doctors; and AstraZeneca settles with the SEC…all in this edition of the Compliance News in Review.

You had to know it wasn’t far away when “pumpkin spice everything” started appearing on store shelves. After the long hot summer, the staff here at the Compliance News in Review couldn’t be more excited that football is back, and cooler days with it (hopefully). Whether you’re a fan of college, or the league where they play for pay, the season is short, but that’s what makes it so special. Yes. football is now our focus, but not so much that we won’t continue to provide you with all the life sciences compliance news fit to blog. So, strike up the band, we’re ready to take the field on this edition of the Compliance News in Review.

The Illinois Attorney General is lining up against Insys. The state has filed suit against the company for illegal marketing of its fentanyl drug. The drug is approved for treating pain in cancer patients, but the AG alleges the company has been marketing the drug for treatment of other types of pain. The company also encouraged doctors to write prescriptions for higher, more expensive doses of its product, despite FDA recommendations to use the lowest dose of opioids possible, according to the suit.

The Association of the British Pharmaceutical Industry (ABPI) threw a flag on Hospira and Napp Pharmaceuticals. The organization has accused the companies of breaking the rules regarding promotion of biosimilars. An investigation found that Napp Pharmaceuticals made inappropriate payments to physicians attending a meeting that was deemed an advisory board. Hospira allegedly invited U.K. doctors to attend a meeting outside the U.K., which was a not a genuine advisory board, where their drug was promoted.

The Australian legislature will huddle about the state of its anticorruption law. After two Australian companies were implicated in a case involving the bribery of foreign officials, a member of the Australian senate decided to relaunch a committee to address corporate corruption. The mission of the committee is to improve Australia’s response to corporate crime and the senator noted that compared to bribery laws in the U.S. and U.K., Australia’s law is inadequate.

The “score” regarding industry payments to physicians in Australia has been posted for public review. Between October 2015 and April 2016 doctors received $8.5 million from industry according to a report from Medicines Australia. The organization says this report provides patients with more information than ever before about the relationship between doctors and the industry, and that the organization’s “standards for ethical and transparency will improve the Australian health care system.”

Thanks to an “ineligible receiver” call from the officials at the SEC, AstraZeneca has agreed to pay $5.5 million to resolve FCPA related charges. The SEC alleged that the company did not have proper internal controls in place related to interactions with foreign officials – mostly healthcare providers – in its China and Russian subsidiaries. The agency contends that improper payments, in the form of cash, travel, and gifts, were documented as bona fide business expenses. While AstraZeneca did not admit or deny any wrongdoing, it did cooperate fully with the investigation.

This week’s review had a decidedly foreign flavor. Where compliance outside the U.S. is concerned, we recall a quote from Pulp Fiction (bet you never thought a Tarantino film would ever be referenced in blog post about compliance) when Vincent Vega is discussing the differences between European countries and the U.S. “They have everything there we have here. It’s just a little bit different.” The same can be said for compliance issues. While the principles or requirements related to drug promotion may be the same here and abroad for the most part, there are small differences between what is permitted in the U.S. and what is permitted around the world. Life sciences companies must train employees about practices that are appropriate when conducting business outside the U.S., particularly in their interactions with non-U.S. HCPs.

With that, the time has expired on this edition of the Compliance News in Review. Don’t forget to click that blue button on the right to “follow” our blog so you’ll receive notifications when we post new content.

Until next time, stay compliant and enjoy the games!

Excel for Tracking Training? Been There, Done That, and Sadly, I Have the T-Shirt.

NXLevel Compliance Team , , , , , , , , , , , , , , ,

As someone who worked in compliance for a small life sciences company, I like to share the problems and pitfalls I experienced over the years, in the hope of saving others from the same fate. Today, we touch on the subject of Learning Management Systems and in particular, my hard-learned lesson about trying to use Microsoft Excel for some LMS functions. I like Excel as a software program overall. And, if you work in training, it may seem like a logical choice for measuring metrics. It’s not. If your company doesn’t have an enterprise-wide LMS in place, or if a particular group of learners (e.g., third-party vendors) doesn’t have access to your internal LMS, I strongly recommend using a hosted or cloud-based LMS  rather than relying on Excel to handle the tracking and reporting.

Is an LMS a Better Option?

The obvious and primary limitation of using Excel is you still need to find a way to host and deploy the training. Even when used solely for the purposes of tracking and reporting, it can be burdensome, error-prone, and time-consuming. At a minimum, you need to enter all of the learner-related data, as well as the list of courses assigned to each learner, and the dates the courses were deployed and completed. Then there’s the on-going need to keep your learners updated with reminders that training is due, and the work necessary to pull metrics from all the data. Using Excel is a manual process, which opens the door for mistakes and those mistakes, are hard to catch when you’re pouring over hundreds of lines of data.

Using a hosted or cloud-based LMS helps automate those processes, greatly improves accuracy, and lightens the burden of the on-going work. While some upfront work is necessary as an administrator, the LMS itself does most of the heavy lifting. Deployment of the training and management of the completion records are handled by the LMS, freeing you from developing formulas and creating your own reports. In fact, you’re likely to get far more insight from the reports and metrics that are standard with most hosted and cloud-based services than you’d ever be able to pull from Excel. And the best part – all of this comes with the ability to host and deploy the training.

Of course, a hosted LMS solution isn’t the panacea to all of your workload challenges. You may not be able to customize the functionality of the LMS, and depending on what service you choose, you may or may not be able to manage your classroom learning with the service. Then, of course, there’s the big elephant in the room, the cost. Reconciling the budget when you think you can manage with the software you already have in house may seem difficult, especially for small to mid-size companies. However, when you factor in the time spent by managing all the tasks manually, the cost may not seem so overwhelming.

What About the Budget?

A number of cost-effective options are available. For example, our PharmaCertify Access™ LMS offers an affordable way for small to mid-size (and even larger) clients to host and track online training, whether it’s developed by us, another vendor, or in-house by our client.

Looking back on that Excel experience, I regret not giving more than a fleeting thought to using a hosted LMS, even though I only had a few hundred learners to manage. I’m sure an LMS would have provided better insight into the impact the training had on the audience, and would have allowed me to dedicate more time and resources to building an even better compliance training curriculum.

Thanks for reading, and stay compliant!

Lauren Barnett
Compliance Content Specialist
PharmaCertify™ by NXLevel Solution

 

 

 

Compliance News in Review, July 14, 2016

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The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

The Right Stuff: Compliance Training in Preparation for Your Company’s First Product Launch

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A first product launch is an exciting and overwhelming time for any life sciences company. So much to do, and what seems like so little time to do it – especially if you are a compliance department of one or two people. As employees are brought on board in support of the launch, planning and implementing an initial compliance training curriculum is a critical task. You need to cover all the essential bases and topics, and direct the training to the appropriate audiences so individuals aren’t burdened and distracted by messages and information that may not be applicable to their job duties.

With that in mind, the team at PharmaCertify™ has compiled a list of suggested topics and audiences for any company working toward an initial product launch.

Topic 1: Code of Conduct
Audience: All Employees

Good code of conduct training introduces employees and external contractors to the behavioral expectations your company has established. It also provides a foundation for understanding the requirements of working in such a heavily-regulated environment. We could fill an entire blog entry with instructional tips for building effective code training, but for now, we’ll make this one suggestion – make it more meaningful with scenarios that demonstrate how the concepts are manifested in their daily activities. Learners need to relate to the information being presented in order for it to stick.

If your company has not yet developed a code of conduct, see topic two.

Topic 2: Overview of Healthcare Compliance
Audience: All Employees

All employees must be aware of the laws, regulations, and guidance documents related to working for a pharmaceutical or medical device company. If your company doesn’t have a code of conduct, or the code doesn’t include basic information about the laws affecting the industry, a compliance overview course is especially necessary to communicate the concepts they need to know. If you do have a code of conduct, consider the idea of narrowing the audience to the commercial, medical affairs, regulatory, and communications groups.

Topic 3: Interactions with Healthcare Professionals
Audience: Sales, Marketing, Medical Affairs, and Customer-Facing Regulatory

Employees whose job responsibilities involve interacting with healthcare professionals (HCPs) on some level need training to ensure those interactions are in compliance with laws, regulations, and company policy. The training should include topics such as the rules associated with providing gifts and meals; the use of HCP consultants; proper conduct during speaker programs and advisory boards, and interactions at medical congresses or other scientific meetings.

Topic 4: Good Product Promotion
Audience: Sales and Marketing

Sales and marketing teams need detailed training regarding the regulations that govern prescription drug and device promotion. Focus your promotional training on how the regulations affect both verbal and written promotional statements. It should include topics such as what constitutes promotional statements versus medical information; what is a proper promotional statement (i.e., accurate, balanced, and truthful); FDA guidance on dissemination of reprints; and the use of social media.

Topic 5: PDMA and Drug Sample Management
Audience: Field Sales

If samples are going to be a component of the product program, training regarding the requirements of the Prescription Drug Marketing Act (PDMA) is needed before the sales representatives receive any of the samples for distribution. The training should be twofold though and include information about inventory management, and your company’s sample documentation processes – a topic just as important for medical device companies as well.

Topic 6: HIPAA
Audience: Sales, Medical Affairs, and Any Group Interacting with Patients or Handling Patient Information

The protection of patients’ personal information is a hot button issue, so you need to ensure those who handle, or who may be exposed to that information, are aware of their responsibilities regarding confidentiality. In addition, credentialing requirements at hospitals and other facilities now require anyone doing business in those facilities to be trained on the requirements of HIPAA and the protection of personal health information. In fact, if your sales representatives are going to be selling in a hospital environment, you will want to add Bloodborne Pathogens and Aseptic Technique training to their curriculum as well, but we will save that for our blog entry on the rise of credentialing and its requirements.

More Information

While the above list of topics constitutes a strong compliance training foundation for any company moving toward its first product launch, the topics and audiences may need to be tweaked based on your particular product and product indication.

The PharmaCertify™ team of compliance subject matter experts and instructional designers are here to help and we are making information available to you. To see an expanded list of the suggested content for each of the topics listed above, contact Sean Murphy, Product and Marking Manager at smurphy@nxlevelsolutions.com, or 609-483-6876.

Thanks for reading and stay compliant!

Lauren Barnett, Compliance Content Specialist, PharmaCertify™ by NXLevel Solutions

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

Buy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for You?

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During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom for online training,” and “off-the-shelf just doesn’t meet my content needs.” She went on to explain that with custom-developed training, she could target specific topics and include company-specific policies in a way that she never could with off-the-shelf.

Fair point, but she failed to take into consideration that while custom-developed training can indeed be built to focus on the compliance content she needs to cover, well-built, flexible off-the-shelf training provides a solid foundation of knowledge, which can then be supplemented with targeted, custom micro-learning in the future, as gaps and custom needs demand.

Start with Off-the-Shelf

Small to mid-size pharmaceutical and medical device companies need effective training covering core topics such as off-label promotion, transparency, gifts and meals, and adverse events, but the training resources and budgets available to many compliance departments, which often consist of a staff of one or two, are quite limited. Instructionally sound, industry-focused, off-the-shelf training can easily and quickly provide core compliance training, without draining your limited resources and time.

For obvious reasons, off-the-shelf, even when tailored to include your specific policies and contact information, can be deployed more quickly than a fully custom training course. Review times are shortened and less demanding, and when a need for training on a specific topic (e.g., speaker presentations) is identified, off-the-shelf gives you the flexibility to deploy rapidly while the topic is still top of mind to your learners. Moreover, with quality off-the-shelf training, content is developed by someone with specific knowledge of the industry, and expertise in commercial compliance. Therefore, your time isn’t consumed with being the primary subject matter expert.

A Time and Place for Custom

This is a need for custom online learning in an effective compliance training curriculum – one that addresses all of your organizational risks and truly helps to build a positive compliance culture. The most recent research points to the importance of spacing learning over time and providing review and reinforcement exercises after the initial training is launched to improve retention. As educational psychologist Steven Just, Ed.D., founder and former CEO of the assessment company, Pedagogue, writes, “To learn, you must cognitively act upon the learning materials, and to retain what you have learned, you must actively re-engage with the learning repeatedly over a period of time.” Starting with off-the-shelf, then mixing in smaller, more cost effective, custom mini modules and interactivities (video scenarios, games, assessments) over time and across a well thought out compliance training plan, has been proven to support on-going behavior change – a key objective in the world of commercial compliance.

Summary

While custom online compliance training should certainly play a role in the on-going execution of your compliance training plan, launching a foundation of targeted, off-the-shelf courses to address important topics to a broad audience represents a rational and cost-effective starting point for any life sciences company’s compliance training curriculum.

Don’t forget to “follow” the PharmaCertify™ blog by clicking the blue link on the right so you don’t miss our updates. Coming soon, The Right Stuff: What Compliance Topics to Cover in Your Product Launch Training.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager PharmaCertify by NXLevel Solutions

News in Review, June 15, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , ,

Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!

Compliance News in Review – In Case You Missed It, April 2016

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Wow, we’re already a week into May 2016. Time flies when you’re staying compliant. If policy writing, auditing, monitoring, or compliance training development kept you too busy to keep up with all of the April compliance news, not to worry, we have a summary of all the compliance news that was fit to blog throughout the month…with the ICYMI, April 2016 edition of the Compliance News in Review.

A new study suggests drug ads aren’t particularly effective in prompting patients to discuss the advertised drug with their doctor. In fact, only 7% of people were moved to discuss a drug with their physician after seeing a televised ad. While they may not be motivated to speak to their physician, viewers do notice the ads. The survey found that 64% of the respondents said they believed they saw more drug ads over the past year.

Shionogi received a warning letter for omitting risk information on a co-pay coupon for a drug that treats lice. The FDA said the coupon touted the efficacy of the product without stating any of the risks.

The Department of Justice announced a pilot program for companies to self-report violations of the FCPA in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for the reduction in penalties.

Pfizer and the DOJ announced the settlement of the case involving Pfizer’s Wyeth unit. The company agreed to pay $784.4 million to resolve charges it had reported false and fraudulent price information to the government.

Ten of Canada’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and multinational firms like Abbvie, Purdue, BMS, and Lilly soon joined.

CMS held a webinar for Open Payments stakeholders. The agency’s remarks focused on program timelines, in particular, the review and dispute period. A question and answer session for participants was included.

The Massachusetts Medical Society is now requiring its members to disclose financial ties to industry when posting information or reviewing a medical procedure or service on the Internet.

With the review and dispute period for Open Payments in full swing, it is good time to make sure those in customer facing roles are up to date on the requirements of the Sunshine Act, and your company’s procedures for addressing questions from covered recipients. Sunshine Act and Open Payments, from the PharmaCertify Foundations™ curriculum of eLearning modules, provides an overview of data collection and reporting responsibilities, and is easily modified to include your company-specific policy on how to handle questions from covered recipients.

Stay compliant and here’s to a merry month of May!

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

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CBI’s 13th Annual Pharmaceutical Compliance Congress, held last week at the Ritz-Carlton in Washington DC, offered an impressive lineup of industry luminaries and government regulators discussing a wide range of compliance-related topics. While some of the discussions didn’t offer much in the way of groundbreaking information (tone at the top, embed compliance in the businesses, relationships matter, etc.), the concepts presented were critical for any attendees new to their role or the world of life sciences compliance in general.

Embed Compliance into Business Practices

There was the expected emphasis on the concepts of embedding compliance into business practices and gaining buy-in from the C-suite. One panelist even mentioned that when asked to join her current company, she insisted that she be a member of the North American leadership team and therefore have direct access to the business leaders. As another speaker put it, “relationships matter, and you have to speak the language of the businesses in their terms.”

Tie Compliance to Incentives

One compliance officer from a small pharmaceutical company referenced the need to make sure sales incentive is tied to compliance, to make the concepts and policies more meaningful – a concept that was considered revolutionary in the industry just a few years ago. She added that sales management needs to own the compliance metrics in order for there to be lasting and real change. The same global officer touched on the challenges of doing business globally and the need to have tough conversations about spending caps. “You will get pushback,” she stressed, “but don’t compromise. There’s no need to take that kind of risk.”

Transparency: Think Globally, Act Locally

Continuing on the global front, presenters reviewed the merits and details of global transparency codes like EFPIA, while touching on upcoming movements toward laws and guidance. When dealing with global regulations and codes, the potential for confusion reigns. For example, when providing meals to HCPs from various countries, one panelist advised audience members to use the lowest common denominator for the meal limit, BUT, don’t forget to take Loi Bertrand into consideration if an HCP happens to be from France.

In addition, panelists stressed that companies can’t fall into the trap of thinking that because they are familiar with the rules around the Sunshine Act and Open Payments, they can roll right into global reporting. As one speaker from a large pharmaceutical company suggested, you have to look at it differently. “If you approach it like you approach Open Payments, your credibility will be challenged.”

Yates Memo and Individual Culpability

Among the regulators and defense attorneys who spoke during the conference, one common theme was the Yates Memo, and the affect it has (or is some cases, doesn’t have) on how investigations are conducted and cases prosecuted. The Memo, which is named for Department of Justice Deputy Sally Quillian Yates, was released in September of 2015. It generally states that the DOJ will increasingly target individuals in corporate crimes. A number of the regulators stressed that while the Memo is significant in its scope, it will not necessarily change how their offices pursue pharmaceutical and medical device cases. During the U.S. Healthcare Fraud Enforcement Panel, one US Attorney said it “codifies what they have already been doing in her office” and another commented that he asks his prosecutors to always look at individual culpability in each case.

Innovations in Training

As a compliance-focused learning company, we at PharmaCertify™ pay close attention to presentations and commentary with a slant toward training. It’s been a slow process, but based on the information and concepts presented in this and other recent conferences, it’s clear to us that companies are integrating exciting and novel techniques into their curriculums. Innovative compliance departments are adding micro-learning solutions and app-based tools in an effort to raise the level of engagement among their learners, which is music to our ears.

One company representative detailed the planning process and upfront analysis she and her colleagues conduct to ensure that training concepts meet the needs of the business as well as the compliance department. Once those needs are identified, they look for unique ways, including a healthy dose of humor, to make their messages stick. She and her co-presenter reviewed the details of the compliance app recently launched across the company, which uses self-produced video sequences, with compliance department employees as actors, to communicate the concepts. While we agree that technique can help to “humanize” compliance, as we warned in a recent post, you need to be careful that bad acting doesn’t distract from the important messages.

While this year’s Pharmaceutical Compliance Congress featured much of the same themes as recent conferences, the ever-evolving world of life sciences compliance always offers new twists and turns for those tasked with ensuring their individual companies remain in alignment with the latest rules and regulations. These conferences offer attendees the invaluable opportunity to learn best practices, tips, and updates directly from their peers and government regulators from around the world. They shouldn’t be missed.

See you at the next conference!

Compliance Edutrainment: Too Much of a Good Thing?

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These days, the standard airline safety presentation is delivered via video on most aircraft. Somewhere along the way, airlines decided this approach was an opportunity to express their creative spirit, and a bit of a competition developed, with the imagined spoils going to the company that produces the most entertaining safety video. That competition reached a new level when Virgin America rolled out its Safety Dance video. It boasts talented singers and dancers (and one Olympian) delivering the FAA- required safety information. If the objective is simply to entertain, then mission accomplished. However, if the objective is to educate passengers about safety protocol, we’re not sure it hits the mark.

The world of compliance training has thankfully evolved beyond the “death by PowerPoint” approach that dominated the life sciences landscape years ago. Those charged with developing compliance training now look to create programs that are more engaging and entertaining. In the case of eLearning, a number of tools and techniques can be applied to deepen engagement and learning, but if overused, or misused, the same tools have the opposite effect and distract from the learning. We call this the Edutrainment Trap.

All good adult learning starts with objectives, answering the question, “What do I want the learner to know and be able to do by the end of this training?” Enamored with the latest tools and ideas, losing sight of objectives once we start to design and develop the learning is easy. Here are five tips to help keep your compliance organization from falling into the Edutrainment Trap:

  1. Use Interactivity Intelligently: The interactivity itself is often overused in online compliance training. Of course, a well thought-out level of interactivity is important, but overloading the interaction on every screen only serves to distract the learner from the salient points. When covering critical topics like off-label marketing and privacy, interactive exercises and games need to be integrated intelligently, and in a manner that doesn’t cloud the learning with unnecessary messages. Interactive elements should serve a purpose, and not just be included for the sake of entertainment.
  2. Include Targeted Imagery: Images and graphics are sometimes misused or overused in a way that distracts from the core objectives. There is truth to the phrase, “a picture is worth a thousand words” and well-placed imagery is certainly more engaging than an overabundance of text on screen. But when the objective is to ensure the learner can “demonstrate an understanding of the payments that need to be reported under the Sunshine Act,” pretty pictures only go so far. Relevant images and graphics that reinforce key concepts and support learning objectives are needed.
  3. Mind the Bandwidth: Video and animation offer exciting opportunities for compliance training, but like any new tools, they need to be utilized judiciously and with the objectives in mind. In this time of high-speed corporate networks, we can forget that bandwidth is sometimes an issue for third-party vendors. An overabundance of video or complex animations may cause problems. Think carefully about geography and access when developing that global transparency module for deployment around the world.
  4. Remember that Acting Counts: If live actors are being used, make sure the subject matter remains the star of the training. Oscar-quality acting isn’t necessary for the training to be effective, but there is a fine line between amusing amateur acting and just plain bad acting. When the goal is to communicate the seriousness of a topic like the Anti-kickback Statute and its implications, amateur acting will derail any hope for effectiveness, as the learners start to pay more attention to the acting, and not the learning. Similarly, the more conversational the dialogue, the better. If the narration sounds like someone is reading a law journal or compliance policy, learners will tune out.
  5. Be Mindful of Cultural Differences: Making cultural references or using humor can be a fun way to interject life into training, but it has to be included carefully. Jokes can lessen the importance of the message. Cultural references that the audience may not understand can frustrate and ultimately distract the learner, leaving them saying “huh?” instead of “I got it.” This safety video by Delta is a great example. The video is entertaining, funny, and clearly communicates the required safety information – all good things. However, if the learners are not familiar with the nature of viral videos and Internet stars, the humor is lost, and the random assortment of characters only leads to confusion.

Avoid the Edutrainment Trap of loading training with every bell and whistle imaginable in the effort to make the learning fun and engaging. A good balance of imagery, text, and interactivity keeps training interesting and flowing and is a necessity in today’s complex regulatory landscape. Understanding which techniques are most effective and appropriate for the learners and the subject matter is the key to developing effective and highly-engaging training.

Thanks for reading and stay compliant!