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!

The Los Angeles City Attorney opens an investigation against one pharmaceutical company, while the founder of another is indicted on federal racketeering charges.

This year’s World Series brought record-setting excitement and late nights (more like wee hours of the morning for those of us in the East) for fans of America’s game. Congratulations to the Houston Astros, who outlasted the Los Angeles Dodgers, in a seven-game extravaganza, just as Sports Illustrated predicted…three years in advance!

If you’re searching for a new pastime to fill the void left by passing of another season, we have just the ticket. Step into the batter’s box as we present all the life sciences compliance news fit to blog, with this edition of the Compliance News in Review.

Leading off this week, a Wisconsin state legislator introduced a bill that will require drug manufacturers to notify the state in advance if they plans to increase the price of a drug by more than 25%. The lawmaker cited the costs to Medicaid budgets and a lack of transparency with consumers as the justification for the bill.

There’s no “Dodging” the Los Angeles City Attorney for Avanir Pharmaceuticals. On the heels of a CNN report, the City Attorney announced that he intends to open an investigation into the company’s prescribing practices for elderly patients in nursing homes. The report pointed to a rise in prescriptions for the drug in question, even though the studies supporting use with elderly patients are lacking. Top prescribers allegedly received speaking and consulting payments from the company.

Canada is pulling facilitation payments from the mound. The Canadian government announced it will repeal the exception for facilitation payments from its Corruption of Foreign Public Officials Act. The repeal was effective October 31. The law had previously permitted payment to expedite routine services, such as obtaining permits and scheduling inspections.

In news from overseas, the Prescription Medicines Code of Practice Authority (PMCPA), the group responsible for overseeing adherence to the Association of the British Pharmaceutical Industry’s Code of Practice (APBI), saw a rise of more than 40% in the number of complaints it received in 2016 about marketing and promotional practices. The complaints led to 100 new cases, with more than half of those resulting in the determination that the Code was breached.

Insys is on the losing end of a doubleheader, with the founder being indicted on federal charges and a New Jersey doctor potentially losing his license for allegedly accepting kickbacks from the company. The founder was indicted on charges of racketeering, conspiracy to violate the Anti-Kickback Statute, and conspiracy to commit mail and wire fraud. The company has been accused of promoting its opioid product for off-label uses and paying kickbacks to healthcare professionals.

The attorney for the New Jersey doctor says his client has never been the subject of a disciplinary hearing, or had a patient complaint in 25 years of practice, and he welcomes the chance to present his case to the medical board.

Speaking of New Jersey, a public hearing was held to receive feedback on the state’s pending regulation, “Limitations on Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers.” The regulation, which was announced by Governor Christie in late summer, includes restrictions related to transfers of value to prescribers of prescription drugs.  Many of the groups in attendance have expressed concern that the regulation’s $10,000 per year cap on bona fide services payments would have unintended consequences on clinical research. The New Jersey Attorney General stated that while some revision is possible, the State is committed to moving forward with the regulation. Public comments will be accepted through December 1.

With that, we end this “boys of summer (and well into fall)” edition of the Compliance News in Review. One final note: if you’re attending the 18th Annual Pharmaceutical and Medical Device Compliance Congress in Washington DC, November 6-8, stop by Booth 112 (back by all the good food!) to see demos of our newest compliance training solutions and the Compliance 365 Continuous Learning System.

See you in Washington!

Friday the 13th Brings Multiple Settlements for One Unlucky Company

CMS posts new Open Payments thresholds, MedTech Europe revises its Code, California deals with two new pharmaceutical laws, and multiple settlements are announced for one “unlucky” pharmaceutical company…in this Friday the 13th edition of the Compliance News in Review.

Be careful what you wish for, Freaky Friday (a.k.a. Friday the 13th) has arrived. Steer clear of those sidewalk cracks, black cats, and broken mirrors! We prefer to focus more on the “Friday” part of the date stamp rather than the “13th.” Whether you’re working for the weekend, or just counting down the minutes until it officially begins, we offer the latest edition of the Compliance News in Review to help you whittle away the hours until the superstitions have subsided.

Change doesn’t have to always be scary. MedTech Europe, a joint venture of EucoMed and European Diagnostic Manufacturers Association, changed its Code of Ethical Business Practice. Changes include the phasing out of direct sponsorship for HCPs to attend medical conferences; enhanced transparency of educational grants; and new guidelines for demonstration products and samples. In addition, starting in 2018, members will only be able to provide educational grant support for meetings that have been vetted by the organization.

The “lucky” numbers for the Open Payments reporting thresholds for 2018 have been posted by CMS. The small payments, or de minimis threshold, was raised to $10.49, and the annual aggregate threshold was raised to $104.90.

California passed two new laws affecting the pharmaceutical industry. First, SB 17 requires health plans and insurers to report information about drug pricing. The information will be compiled into a report showing how drug pricing effects health insurance premiums. The law also requires drug manufacturers to notify purchasers 90 days in advance if a drug’s wholesale acquisition cost (WAC) is going to increase.

AB 265 prohibits prescription drug manufacturers from offering assistance to lower out of pocket costs, if a lower-cost generic equivalent drug is available. Exceptions include the discounts required under an FDA Risk Evaluation and Mitigation Strategy (REMS); single-tablet drug regimens for the treatment of HIV or AIDS that are as effective as a multi-tablet regimen; and completion of step therapy or prior authorization requirements for a branded drug, as mandated by the individual’s health coverage.

Time to start throwing copious amounts of salt over the shoulder at Aegerion. The company pled guilty and pay over $35 million to settle criminal and civil charges that it violated the FDCA, HIPAA, and the False Claims Act. According to the Department of Justice, Aegerion did not follow the proper Risk Evaluation and Mitigation Strategy when educating prescribers about the rare cholesterol condition its drug was approved to treat. The government also claimed the company filed a misleading REMS report and promoted the drug for the general treatment of high cholesterol, all in violation of the FDCA.

Aegerion also resolved civil charges it violated the False Claims Act. The company allegedly shared misleading information about its drug, altered or falsified statements of medical necessity or prior authorization to federal healthcare programs, and defrayed the copay obligations of patients in federal healthcare programs, which is a violation of the Anti-Kickback Statute.

Following the settlement, the patient assistance organization involved, Patient Services, Inc. (PSI), acknowledged it received a subpoena from the DOJ. PSI said it had cooperated with the government in the case. The organization said it operates “under guidelines set by the U.S. Health and Human Services Office of the Inspector General and does not funnel funds for manufacturers.”

Some “strange magic” leads to a $13 million FCPA settlement for Alere to resolve charges it violated the FCPA. The company allegedly paid bribes to meet its revenue targets. According to the SEC, company subsidiaries in India and Colombia used distributors or consultants to make improper payments to foreign officials. The agency said the company failed to maintain adequate internal controls to prevent the payments and recorded the payments incorrectly.

With that, we close out this superstitious edition of the Compliance News in Review. Thanks for reading! Stay safe out there as you navigate the potholes and pitfalls that allegedly lurk in shadows, and no matter what, don’t walk under that ladder!

Compliance News in Review, September 22, 2017

Reprimands in the UK, opioid manufacturers face another investigatory group, and registration processes for Nevada representatives, all in this week’s Compliance News in Review.

Ready or not, Fall is here! Leaves are turning, football is back, the oppressive heat of Summer is fading, and pumpkin spice everything is available. We are certainly fans of Autumn here in the offices of the News in Review and we’re ready to break out the flannel shirts, boots, and maybe a knit cap to enjoy the cooler evenings ahead. We are also fans of compliance! So, grab a pumpkin spice latte and settle in to this edition of the Compliance News in Review.

A nip in the air, and a nip at the marketing practices of several companies by the ABPI. The industry organization reprimanded Pfizer, Novartis, Astellas UK, Astellas Europe, and TOR Generics for breaches of its Code. Pfizer and Novartis were both cited for misleading promotion, and unclear materials used by representatives. Astellas UK and Astellas Europe voluntarily admitted that prescribing information for several of their products omitted references to adverse events. Lastly, TOR Generics was accused of promoting an unlicensed product, which was expected to be a prescription-only product, in a public magazine.

A new team is investigating opioid marketing. 41 state attorneys general formed a coalition to investigate opioid manufacturers and distributors. The group subpoenaed several top manufacturers, and wholesale distributors Amerisource, Cardinal, and McKesson. The AGs want to know if manufacturers deceived healthcare professionals about product efficacy and addictiveness.

Time to turn over a new leaf in Nevada. The state published draft procedures for the registration of pharmaceutical representatives. Individuals who work in Nevada for at least five days a year and communicate with healthcare professionals, or participate in the activities listed below, must register with the state’s Department of Health and Human Services (DHHS):

  • Marketing of prescription drugs to healthcare providers, pharmacists or pharmacy employees, and employees of medical facilities
  • Meeting with healthcare providers to answer questions about product use and benefits, or to provide discussion and product information and resources to those providers or other decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer
  • Distributing FDA regulated product samples and product information

These activities are excluded under the law:

  • Attending a conference in Nevada that is not exclusively marketed to Nevada healthcare professionals
  • Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies
  • Activities performed by wholesale distributors who do not represent a single manufacturer

Companies are required to notify DHHS as employees are hired and terminated, and employees must be registered with DHHS within 30 days of hire.

With that, we wrap up this edition of the Compliance News in Review and head outback to roast marshmallows and make smores! If you can’t join us by the fire pit, we’ll catch you back here for our next issue.

Thanks for reading!

Discount Registration: Pharmaceutical and Medical Compliance Congress

The 17th Annual Pharmaceutical and Medical Device Compliance Congress is scheduled for October 19-21 and the PharmaCertify team is looking forward to catching up with colleagues and sharing demos of our newest compliance training solutions. As a conference sponsor, we have the opportunity to offer you a $600 discount on the full conference registration cost. If you’re interested in taking advantage of this opportunity to hear industry professionals and government regulators discuss the latest guidance and share best practices, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

If you can’t make it this time, don’t worry, we’ll be posting updates on the PharmaCertify Twitter feed, and a conference review on the our blog soon after the conference closes.

Thanks for reading and stay compliant!

 

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

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

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!