A Preview of the 15th Annual Pharmaceutical Compliance Congress!

The 15th Annual Pharmaceutical Compliance Congress is only a week away and the conference agenda offers a new twist on the standard array of presentations by industry leaders and government regulators. Here are some of the presentations and panel sessions the PharmaCertify™ team is looking forward to:

Day 1: Tuesday, April 24

CCO Exchange
Adapting and Evolving Compliance Programs in Support of Innovation

Following the chairman’s opening remarks, and the “luminary address” that kicks off the conference, this panel session features leading industry representatives, including Maggie Feltz of Purdue Pharma and Sujata Dayal of Johnson & Johnson. The title is intriguing and I look forward to hearing the panelists discuss how they have adapted their programs, and their training curriculum, to take advantage of advances in technology and new concepts like microlearning and continuous learning.

Stakeholder Spotlight
Evaluation of Compliance Programs from the Internal Customer Perspective

The focus on “internal customer perspective” in this session caught my eye. It’s a stakeholder group that is not often discussed at conferences, and I’m curious to hear how the presenters define internal customers and the parameters and tools used tools for evaluation.

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel
Past and Present Prosecutor Parley 

The description of this unique session promises a “point/counterpoint” approach to the subject matter, with current and former prosecutors and defense attorneys presenting their views on recent settlements and on-going investigations. Typically, the two sides present in separate sessions, so this joint “parlay” approach should prove to be engaging and revealing.

Patient Assistant Programs (PAPs) and Reimbursement Hub Services Compliance
A New Wave of Enforcement Actions

The latter part of the title makes this session so compelling and the “wave of enforcement actions” has led to several of our clients asking about training on PAPs and Reimbursement Services compliance (look for that addition to our curriculum of customizable off-the-shelf compliance modules in the near future). I am curious to hear how the industry representatives on the panel are dealing with the need for training considering the growing regulatory focus.

Master Class Series 3
Behavioral Compliance – Using Behavioral Psychology to Make Compliance Programs More Effective

This one is on the top of my list! After spending over ten years in the life sciences compliance training space, I recognize the key to flattening the proverbial “forgetting curve” is the utilization of modern and continuous learning tools and techniques built on advances in behavioral psychology and the science of learning. Look for me in the front row!

Day 2: Wednesday, April 25

Patient Support Programs Track
All Three Sessions

Continuing the focus on Patient Assistant Programs and Reimbursement Hubs covered in one session on Day 1, this track features three sessions that should shed light on a burgeoning area of enforcement: Evolving Role and Landscape of Patient Advocacy in Life Sciences; Mitigate Risk Within Hub Operations; and Legal Nuances and Limitations of Drug Copayment Offset Programs.

Small to Mid-Sized Bio/Pharma Working Group Track
Beyond the Seven Elements of An Effective Compliance Program – What Else Are You Doing?  

The definition of an effective compliance program has evolved well past the point of simply covering the seven elements first established by the OIG years ago. From a training standpoint, modern continuous learning techniques and tools have the potential to increase the retention of key compliance concepts and further reduce risk. I am curious to know what strategies the four industry professionals featured in this session have integrated into their programs to make it even stronger.

Small to Mid-Sized Bio/Pharma Working Group Track
Maximization of Compliance Resources

I may be a little biased on this one since my colleague, Dan O’Connor, will be joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals to discuss strategies for building and maintaining a strong compliance program when resources are at a minimum due to staffing and budgetary constraints.

Transparency and Open Payments Track
CMS Transparency and Open Payments Update
Existing and Emerging State Laws Governing Transparency Reporting
      

With transparency being such a regulatory focus and risk area, I anticipate a large and rapt audience for the presentation by Robin Usi, Director for the Division of Data and Informatics at CMS. In addition, the ever-changing list of states updating their existing transparency laws, as well as those launching new regulations (we see you New Jersey), moves the second session high on our attendance sheet.

Compliance Café and Community Exchange

Kudos to CBI and the panelists involved for this novel and clever way of closing out the conference! This collaborative session offers a great opportunity for attendees to collaborate with their peers and exchange ideas and suggestions from what they heard throughout the conference, and most-importantly, “align learnings and develop next-level strategies to take back to the office.” Well done.

The 15th Annual Pharmaceutical Compliance Congress promises a plethora of opportunities to catch up on the latest in regulatory and enforcement news, as well as best practices for building and strengthening an effective compliance program. We hope you’ll take a few minutes in between sessions to visit the PharmaCertify Booth in the Exhibit Hall to say hello and see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients.

Thanks for reading and we’ll see you in Washington!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

The 2017 Compliance Year in Review!

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

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!

18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

Life Sciences Compliance Congress West: A Preview

CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!

Compliance News in Review, July 7, 2017

Canadians, Californians, and Mainers are all on the hunt for transparency. Will they find “gold” they seek? Find out in this week’s News in Review.

There’s gold in them thar hills! Seriously. A number of years ago, a man hid an estimated $2 million treasure of gold and jewels somewhere in the Rocky Mountains, leaving only a cryptic poem to guide treasure hunters to the stash. At the time, he said he hoped it would inspire folk to get up off their couches and explore nature. Many have, and unfortunately, a couple of them met an untimely end during that search. As far as anyone knows, the treasure is still out there for the taking, but before we break out our atlases and sharpen our pickaxes, let’s dig into the news of the day in this edition of the Compliance News in Review.

Pharma companies will be able to hold on to their doubloons if an amendment to the California bill prohibiting gifts and restricting payments to doctors stands. Legislators eliminated the penalties associated with the bill, but added a provision that prohibits doctors from receiving payments for speaking or serving as faculty at events that are not accredited by the ACCME or a similar organization.

A pair of Canadian doctors are on the hunt for transparency with a program intended to gain support for more industry/physician transparency. According to one of the doctors, “interaction with industry is everywhere and a lot of progress has come from collaborating,” but he worries that trust will be eroded if they continue to “keep relationships in the dark.”

Providing some clues to the transparency hunt, ten of the largest pharmaceutical companies in Canada released information on transfers of value they provided to healthcare professionals and organizations. The effort was headed by GSK, and included AbbVie, Merck, and Eli Lilly. Total payments for all the companies came in just under $50 million and covered the 2016 calendar year. Critics complained the data provided little real transparency because the figures represented the companies’ aggregate payments to all doctors or healthcare organizations, rather than individual practitioners or organizations.

The release of this data prompted one treasure hunter, Ontario’s health minister, to announce he will investigate the concept of requiring pharmaceutical companies to disclose physician payment data (a la the U.S. Sunshine Act). He said the voluntary release of recent spend data by certain pharmaceutical companies was a good start, and that the government is “committed to strengthening transparency across the healthcare sector.” Consultations into the matter are scheduled for this summer.

Trekking across the Canadian border to Maine, we discover the legislature has passed a bill that will curtail payments from pharmaceutical companies to doctors. The bill prohibits the provision of “cash gifts” but allows non-monetary gifts of “minimal value.” It also allows doctors to receive payments for speaking about research at “legitimate educational conferences.”

For those wishing to do a little prospecting, the Open Payments data for the 2016 is now available. Nearly 1,500 companies reported transactions totaling $8.1 billion. Just over half of the $8 billion went toward research. A billion dollars was paid in ownership interest, and just under $3 billion fell in the general payments categories. Nearly 12 million records were published this year, covering 631,000 physicians and 1,146 teaching hospitals.

There’s a certain theme running through this week’s news bites. Transparency. Governments, academia, and special interest groups, all extol the need for transparency in the relationships between life science companies and healthcare professionals. Although most of the heavy lifting regarding data is typically handled by a small group of dedicated data hounds, others in the organization need to be aware of the laws and their restrictions.

Those who interact with healthcare professionals need to know the types of information that is reported and understand their role in assuring the accurate and timely collection of the data. As the saying goes, “garbage in: garbage out,” and considering that many of these laws carry financial penalties for reporting errant data, companies certainly want to take steps to reduce the “garbage.”

Well, we’ve reached the end of the trail on this edition of the Compliance News in Review. We’ll see you right back here for the next edition.

Thanks for reading!