Well, William and Catherine got to the church on time this morning in England, and what a lovely wedding it was. Best wishes to the happy couple. Now that the obligatory royal wedding reference is out of the way, onto the compliance news week in review.

The big news of the week was the presentation of arguments before the U.S. Supreme Court regarding Vermont’s data mining law. The case, Sorrell v. IMS Data Inc., centers on whether the law violates IMS’s first amendment right to free speech. The state of VT contends that the prescribing information IMS sells to pharmaceutical companies ultimately causes the state to pay higher healthcare costs by having to pay for high priced branded prescription drugs (um…okay), and hence the law prohibiting the sale of this data.

The Supreme Court is expected have a decision in the case in June. In the mean time, Vermont Law School professor, Cheryl Hanna, has an interesting perspective on the case. She asserts the state doesn’t stand much of a chance as the law itself is full of problems. Even those justices one would presume to be more receptive to the state’s argument expressed concerns with the intent of the law.

Also on the state law front is the news that the Massachusetts House voted to repeal the state’s gift ban to physicians (and the restaurant industry said “Amen!”).  Proponents of the repeal say the ban has done nothing to lower healthcare costs, has driven away medical meeting business and halted the growth of businesses in the state. Those in favor of keeping the ban dispute the notion that the law stymied growth, and argue that the law is needed to prevent conflicts of interests. Now it’s up to the MA Senate to decide if the law should be repealed.

Obviously, state laws continue to impact the pharmaceutical industry. We can help you keep your team up-to-date on these laws with our State Reporting and Disclosure Laws training module.

A couple of settlements were announced this week. The first was by the wholesaler, Cardinal Health. Cardinal agreed to pay $8M to settle allegations of violations of the federal Anti-kickback Statute. Brought by former pharmacy owner (and ex Kansas City player), Daniel Saleaumua and consultant Kevin Rinne. Saleaumua claims that Cardinal Health paid him $440,000 in exchange for an agreement to purchase drugs for his pharmacy from the wholesaler. Apparently, the government pays almost as well as Cardinal. The two whistleblowers will share an award of $760,000. Par Pharmaceuticals also announced that it had reached a settlement in principle, for $154M, to resolve claims related to price reporting in a case brought by Ven-A-Care Pharmacy. Par is just one of several manufacturers named in the Ven-A-Care suit.

As most of you know, earlier this month the CEO of Forest Labs received a letter from the OIG saying it intended to exclude him from participating in the federal healthcare programs. If the exclusion is enacted, the CEO will need to leave the company in order for Forest Labs to continue to participate in federal healthcare programs. The Wall Street Journal (subscription may be needed) reported this week that the exclusion is based on a little-used executive policy in the Social Security Act, which allows the government to exclude executives of healthcare companies found guilty of misconduct. The executive does not have to have been involved in, or even be aware of, the misconduct, in order for the policy to be enacted. The letter came on the heels of Forest’s final settlement with the government over marketing practices related to two of its antidepressants. The CEO was not alleged to have done anything wrong during that investigation.

This week also marked the start of the trial for an ex-GSK lawyer accused of obstruction, making false statements and falsification of documents related to an FDA inquiry into promotional practices of GSK’s drug Wellbutrin SR . During the opening arguments, the prosecutor categorized her as a lawyer who went too far in protecting her client. The defense argued that she acted in good faith in responding to the inquiry.

Since we led off this week’s wrap up with a mention of the royal wedding, we’d be remiss in not reminding everyone of some fireworks occurring on our country’s shore; the final launch of the space shuttle Endeavor. Sadly, today’s launch was scrubbed, but it is tentatively scheduled for Monday. The Endeavor mission will mark the second to last mission for the space shuttle program.  Good luck and Godspeed to the crew!

That’s our news for the week. Until next week, follow us on Twitter for daily news postings and visit us at www.pharmacertify.com to learn more about our off-the-shelf and custom compliance training solutions.

The PharmaCertify Team

For many of you, today is Friday, so we’re bringing you the news review a day early this week. If you are actually having Thursday on a Thursday, we hope you enjoy our little summary early, and hey, for kicks, read it again tomorrow. What would Friday be without it, right? On to the news….

To start, we’ll wind back to last Friday, with the news that the former InterMune CEO, Mark Harkonen, was sentenced to 6 months of home confinement and ordered to pay $20,000 in fines for his wire fraud conviction in the Actimune scandal. The government was asking for a 10 year prison sentence, but the judge said the government had failed to prove the press release at the center of the case had actually caused harm to anyone.

Our next case proves that doing the right thing does pay, but maybe it should just pay better. Last week we told you about the settlement of the false claims case against Mequon, the maker of Dr. Comfort inserts and shoes for diabetics.  One of the whistleblowers, a manufacturing worker, received a reward of $800,000, which after taxes and lawyer fees, will net the man about $250,000. Meanwhile, an executive of the company received a $4 million reward for his part in the case. While the manufacturing worker is happy to have received a reward, he is not happy that someone who he felt was part of the problem received immunity from the government and now has a substantial share in the award.

Ultimately these two individuals went to the government on two separate issues related to the case.  Each filed his own qui tam suit about a month apart. The government felt both cases had merit, and the two were combined and each individual received a share of the reward. It just so happened that the executive had the better paying dirt.

The hit parade of stories about local doctors being paid by pharmaceutical companies and the evils of these arrangements continued this week. On the hot seat this week were central FL doctors. When is sweeps period over?

Not to be out done, the Association of the British Pharmaceutical Industry is requiring companies to make public what they pay to physicians in consultant fees. This requirement is a part of the ABPI’s updated Code of Practice for the Pharmaceutical Industry, which becomes effective on May 1. Healthcare professionals will also be required to declare their ties to the industry when speaking or writing on behalf of a company, and companies will have to ensure the disclosure is made.

While we’re across the pond, Deloitte released the results of a poll in which 73% of respondents said they were not familiar with the provisions of the UK Bribery Act, which becomes effective July 1 (or 1 July for the internationally minded). Not surprising, considering the confusion that exists as to whom this law actually applies.  Deloitte conducted the poll during a webcast centered on remaining compliant with the FCPA while doing business in Brazil, Russia, India and China.

Back in the good ol’ U.S. of A., a Stanford University report calls in to question the safety of off-label use of an expensive blood clotting drug. The drug is supposed to be given to hemophiliacs, but the Stanford report found the majority of the drug’s use is off-label for non-hemophiliac patients undergoing certain surgical procedures. Due to the powerful clotting ability of the drug, researchers are concerned that  patients are at risk of developing dangerous blood clots, endangering the patient’s health with no notable benefits.

That’s our shortened week in the news. Enjoy your Good Friday, Earth Day and Easter holidays! We’ll see you right back here next Friday.

For those who are heading to SPBT in a few weeks, be sure to attend our workshop on compliance training, with Cinda Serianni of Gilead! To learn more about our suite of compliance courses, covering topics such as FCPA, On-label Promotion and the False Claims Act, visit www.pharmacertify.com.

The PharmaCertify™ Team

It’s April 15, and it’s not tax day! What a way to start out a Friday! Here’s the week that was in PharmaCertify compliance news.

There were more developments this week in the FCPA case against Lindsey Manufacturing. The judge in the case heard arguments to dismiss, on the basis that the law was not intended to apply to employees of entities like the government run power company in Mexico. The defense argued it was not the intent of the Act to include such entities in the definition of “foreign official,” and to include them made the law untenably broad. The judge disagreed, and held that the employees of the power company were indeed foreign officials, under the FCPA.

Also on the FCPA front, Grant Thorton and Ethicspoint teamed up to write a whitepaper on 10 common misconceptions that could expose companies to FCPA violations. The DOJ has made it clear that FCPA is an area of priority for them, and has even created special units to investigate possible violations.  The misconceptions range from “my ethics and compliance program is already clear” to “provision of travel expense is common place in my industry.”

In settlement news this week, J&J agreed to pay $78M in fines to both the U.S. and U.K. to settle bribery and kickback charges. The investigation arose after a self-disclosure by J&J, and the U.S. authorities praised the drug maker for its cooperation and remedial efforts. Other pharma companies have announced they are subject to similar investigations. Are we on the verge of seeing similar settlement announcements?

The week also found individuals entering into settlement arrangements. The former CEO of Mequon agreed to plead guilty to mail fraud and pay $27M in fines for improper Medicare reimbursements to the company. The company makes Dr. Comfort shoes and inserts for diabetics. The plea and fines come as a condition of sale of the company to DJO Global Inc. In addition to possible jail time, the CEO will be barred from participating in federal healthcare programs, and the company will enter into a CIA with the OIG.

In the words of Gomer Pyle, “Surprise, surprise, surprise.”  Just weeks after the case was dismissed, a former GSK lawyer was re-indicted on charges of making false statements and obstruction in connection to an investigation of the company’s marketing practices. The trial is tentatively scheduled to begin next month.

On the state forefront, two members of the Ohio General Assembly introduced legislation that would create an Ohio False Claims Act. The legislation, which has the backing of state AG, Mike DeWine, would make the submission of fraudulent reimbursement claims illegal and give the Attorney General’s Office investigatory authority. The law also includes a Whistleblower provision, allowing whistleblowers to collect a portion of the recoveries and protect them from retaliation by their employer.

In North Carolina, a bill has been introduced that, according to Attorney General Roy Cooper, will jeopardize the state’s ability to receive recoveries in Medicaid and other settlements. The AG warned that if passed, the bill would cost the state hundreds of millions of dollars in settlements over illegal marketing and other violations.

Our final story is so full of twists, turns, and scandal, that if hadn’t appeared in the Wall Street Journal, you’d swear it was a plot line of one of the soaps ABC canceled this week.

A Portland, OR neurosurgeon had his operating room privileges revoked in the wake of a controversy of unnecessary surgeries and his business relationship with the medical device distributorship that supplied him with spinal implants. In a previous article, the WSJ found that the surgeon in question was performing spinal fusion surgeries at ten times the national rate. In the latest developments, the WSJ found the surgeon had a business interest in the distributorship that supplied him with the spinal implants. Apparently, the distributorship paid the surgeon a “dividend” each time one of its spinal implants were used. Both the OIG and CMS have stated that this type of business arrangements (known as physician-owned distributorships, or PODS) may violate the Anti-kickback Statute. The surgeon has denied that he performed unnecessary surgeries and that he has a business interest in the medical device distributorship.

That’s the PC news roundup for this week. Remember, PharmaCertify offers training on a variety of commercial compliance topics, including the Anti-kickback Statute, False Claims Act and the FCPA. Please visit www.pharmacertify.com for more information.

Until next week, keep an eye on this blog, and don’t forget to follow us on Twitter.

Enjoy the weekend!

The PharmaCertify™ Team

There were a couple of interesting items this week on the international compliance front. First, an important FCPA case featuring a small family owned business in California. Employees at Lindsey Manufacturing are accused of giving a yacht and a Ferrari to executives at the state owned Mexican power company. The executives say they had no idea that their sales representatives in Mexico used the money they were given in this manner, and they are seeking their day in court.

At the center of this case is the question of who is “a government official.” In many countries, the lines are blurred between private enterprise and government agencies. The case also sends a message that small companies are just as much a target as the large multi-nationals when it comes to the DOJ pursuing FCPA violation charges. Since Lindsey Manufacturing can no longer get credit from suppliers or vendors due to the charges, the company has nearly been driven out of business.

The Lindsey case points to the clear need for smaller companies to be sure their employees and agents have been trained on the requirements of the FCPA, and that executives in these companies are aware of what their agents are doing.

The UK Ministry of Justice and Serious Fraud Office (SFO) recently released guidance on the UK Bribery Law going in to effect this year.  Unfortunately, the guidance has not proved to be particularly helpful in the minds of UK consultants working in this area. According to a report in Operational Risk and Regulation (registration required to view), the guidance does clear up some questions, but other gray areas, including exactly who this law will affect, are not clarified.

Back in the U.S., CMS held a teleconference this week with stakeholders, including representatives from PhRMA, BIO and AdvaMed, on the pending regulations for the Physician Payments Sunshine Act. Industry representatives answered with a resounding “No” to the question of whether additional spend categories and requirements should be included in the regulations.

Discussion also included clarification of how payments that could be reported in multiple categories should be handled, and expanding the types of providers on which spend must be reported. The latter being proposed by a consumer-advocacy firm based in Massachusetts, where the law requires companies to report spend on Nurse Practioners and Physician Assistants. A representative from AdvaMed urged that context be provided as to the nature of the payments since patients could easily misinterpret the relationship between a company and the physician, without an explanation of why the payment was made.

The DOJ filed a compliant against Healthpoint Ltd. for False Claims in relation to reimbursements for an unapproved drug. The government claims Healthpoint stated their drug was eligible for Medicare and Medicaid reimbursement, despite the active ingredient being declared ineffective and having its market approval revoked by the FDA in the 70s. The statements caused millions of dollars in ineligible claims to be paid.

In the resolution of a similar case, Pennsylvania received its $1.8M payout from a government settlement with two pharmaceutical manufacturers over False Claims resulting from claims submitted for unapproved drugs. Like the previous compliant, the drugs involved in this case were not approved as safe and effective by the FDA and therefore not eligible for reimbursement under Medicare and Medicaid.

Are the days of the in office meal and physician consultants coming to an end? Very possibly. Spend disclosure requirements have become more widespread, and now with the passage of the Sunshine Act, doctors are questioning whether it is time to sever ties with the industry. As we know in the compliance world, just the perception of “wrong doing” is enough to raise an eyebrow, and doctors are feeling the same way about the perception of a conflict of interest in their relationships with pharmaceutical companies.

A study published in PLoS Medicine, concludes that most common off-label marketing practices are the ones most difficult to control through regulations. The study authors analyzed 41 off-label complaints brought by whistleblowers and found that there are three primary goals of off-label marketing. The researchers found that to achieve these goals, companies employed a variety of “internal” methods that encouraged off-label promotion. Methods included setting sales quotas which could only be achieved if products were marketed off-label and evaluating patient files for possible off-label uses of drugs. The cases reviewed were either settled or unsealed between 2004 and 2010.  While the authors admit the information contained in the documents could not be verified as accurate, they believe their research may help in developing better regulations.

And finally – To double glove or not to double glove, that is the question. Infection Control Today deals with the myths and the truth around the protection double gloving provides. The article presents compelling evidence that double gloving does provide additional protection against accident sharps sticks and glove failure without compromising dexterity. So the next time you have blood drawn, you may want to insist the nurse, phlebotomist etc. double glove!

That’s the PC news roundup for this week. For those of you attending CBI’s West Coast Aggregate Spend Forum next week be sure to attend Kim Life’s (subject matter expert for PharmaCertify’s State and Federal Spend and Disclosure Requirements module) session, Strategies and Best Practices for Aggregate Spend Training.

Please visit us at www.pharmacertify.com for more information on training topics such as On-label Promotion and Bloodborne Pathogens.   Until next week, follow us on Twitter.

Enjoy the weekend!

Peggy Whitmore

R-Squared Services & Solutions, Inc.

The Foreign Corrupt Practices Act (FCPA) bribery provisions apply to U.S. companies and citizens, foreign companies listed on a U.S. stock exchange, or any person acting while in the United States.  While determining whether the law will apply to a particular person or entity may depend on the particular facts and circumstances of the situation or relevant relationships, and may well depend on differing legal theories (for example, technically the law does not apply to foreign subsidiaries of U.S. companies but the Department of Justice has taken the position that it does), U.S. companies can be held liable for the actions of their employees and agents.

A company may be held responsible even if it does not explicitly approve an employee’s or agent’s improper actions, but simply goes along with the actions; or if a third party responsible for a bribe is deemed to be the company’s agent because the company has “effective working control” over that third party.  As such, it is a good idea to train employees and agents about FCPA prohibitions and their obligations to prevent and refrain from engaging in bribery.

The PharmaCertify™ Team

To borrow a quote from Yogi Berra, it was déjà vu all over again with this week’s big story. The long awaited release of guidance from the FDA regarding use of social media by industry was delayed…again.  The FDA gave no timeframe as to when to expect their guidance.

Other activity from federal agencies this week included an announcement from HHS that training would be offered to the state attorneys general on how to file HIPAA lawsuits. The HITECH provision allows states to bring lawsuits regarding HIPAA violations. For your reading pleasure, the OIG posted updated CIA information.

In the Federal Court of Appeals for the 4^th Circuit, a divided court held up a lower court’s ruling that the secrecy provision for False Claims Act suits brought by whistleblowers does not violate the public’s right to access court proceedings. The court said the provision does not prohibit whistleblowers from discussing the fraudulent actions which are at the center of the suit, but just from revealing that a qui tam lawsuit has been filed.

In state news, the Kentucky Attorney General, Jack Conway, announced a $10.2M settlement with Alpharma USPD, Inc. and Purepac Pharmaceutical Co. over inflated Average Wholesale Pricing.

This week both Pfizer and GSK released information about monies paid to physician for their services as consultants, speakers, clinical trials and for other items. And speaking of aggregate spend, if you missed our webinar “Practical Strategies and Tips for Aggregate Spend Compliance Training” with Kim Life, it is now available at pharmacertify.com.

Across the Pacific, the chief executive of industry group, Medicines Australia, says the “industry feels besieged” in the wake of a slew of new laws aimed at the industry. The Medicines Australia chief believes these laws will make it even more difficult for the industry to compete in the world market, hurting the $4B export market in Australia.

In an interview, former DOJ deputy chief, Mark Mendelsohn, says the trend toward prosecuting individuals for violations of the Foreign Corrupt Practices Act is likely to continue. A subscription is required to read the full Wall Street Journal article.

That’s the PC news roundup for this week. Remember, PharmaCertify has the subject matter expertise and solutions you need to train on critical compliance topics like HIPAA, On-Label Promotion and the FCPA. Please visit us at www.pharmacertify.com for more information. Until next week check out our blog, and follow us on Twitter.

Enjoy the weekend!

Caroline Bennett

Director, Learning Strategy

PharmaCertify has developed a unique learning program to compliment our off-the-shelf eLearning modules and provide ongoing training for key compliance topics.  As part of a complete culture of compliance, the Alternative Reality Challenge blended learning program is designed to immerse learners in a near-realistic, multi-media “game.” This experience challenges their understanding of the chosen compliance topics in a non-threatening, on-the-job context and provides management with insight into their employees’ ability to apply their knowledge of the compliance topics.

The learning environment for the Alternative Reality Challenge is comprised of a customized website, emails, and physical props such as receipts, expense reports, invitations, and other documents to portray a “real” situation and related events. At different points during the program, learners are required to complete self-study assignments as well as team-based activities—before, during, and after the live workshop—to decipher content and interpret the circumstances of the challenge. During the workshop phase, which normally takes place at a POA or other such event, learners are grouped into teams and work together on the challenge. At the conclusion of the workshop the teams present their reactions and analyses. Management can evaluate and gauge comprehension, immediately identify gaps, and provide additional guidance.

The Alternative Reality Challenge takes advantage of several key adult learning principles. It offers a practical, goal-oriented, and problem-centered learning environment for self-directed learning as well as team-based collaboration. It also provides learners the opportunity to bring their own work-related experiences and knowledge to the learning as it appeals to a variety of learning preferences. By addressing multiple learning principles, it maximizes the realization of your learning objectives.

PharmaCertify offers a comprehensive compliance curriculum that is easily customizable and includes off-the-shelf eLearning modules, workshop activities, and handbooks. The programs, which cover topics such as State and Federal Spend and Disclosure Requirements, On-label Promotion, and Essentials of the Foreign Corrupt Practices Act, feature content specifically targeted to pharmaceutical and medical device sales and marketing professionals. PharmaCertify compliance modules can be deployed on your existing learning management system or hosted on the PharmaCertify LMS.

Jane Chin, Ph.D.

Special to PharmCertify

One of the trickiest areas for MSL professionals to navigate is the “scientific exchange.” What can you, the medical science liaison professional, discuss? Should you initiate any and all discussions? Can you, the MSL, boldly talk where no sales reps can ever talk before? (Or at least, those sales reps who follow the rules of compliance and company policies).

MSLs will often express resistance at being told what they can talk about, and how they should talk about it, when meeting with key opinion leaders (KOLs). Experienced MSLs, who have worked in the field for 10 years and have strong relationships with their thought leaders may feel like they have a proven track record of knowing what to say and how to say it. They may not appreciate being told by a company policy (or the company’s compliance officer) “how” they should do their jobs. They may say, “They hired us because we’re professionals, they should trust that we know what’s appropriate.

They have a point. In general, MSLs are aware of the landmines around off-label promotion, and the last thing they want to risk is being mistaken as a sales rep who is promoting off-label. On the other hand, the company has a point in wanting to control clinical conversations. It is also aware of the landmines around off-label promotion. The last thing the company wants to risk is giving MSLs free rein over how clinical discussions should be conducted, especially when questions about off-label use can arise over the course of the discussion!

Some companies have begun requiring KOLs to submit a written request to see a medical science liaison before that meeting can take place. In other words, MSLs in these positions have now become responsive entities, no longer capable of proactive engagement. Some fear that this is a harbinger of doom for the existence of the MSL role. I suggest that this does not eliminate the need for MSLs, but certainly sets up the possibility of a significant number of MSL positions being downsized. MSLs would essentially become a group of field-based “medical/drug information” professionals, dispatched in response to a formal written request from a KOL.

So bigger questions arise: what should differentiate the MSL role from the sales role in therapeutic areas that are highly specialized? What can MSLs initiate in a scientific exchange without a formal request?

MSLs can answer very broadly, “We will discuss disease state.” That leads to the question of “what” about the disease state? Should all MSLs in the team begin the disease state discussion the same way? Can’t specialty sales representatives also talk about disease states?

The complexities of scientific exchange that today’s MSLs must navigate have increased. This requires companies with field-sales and field-medical teams to draw clear distinctions both for thought leaders and for themselves between these two functions. Companies need to differentiate the roles of their field-medical teams from their field-sales teams especially when the sales representative and MSL may interact with the same thought leader. Only then can companies preserve the sanctity of these two field-based roles.

Peggy Whitmore

R-Squared Services & Solutions, Inc.

Corruption and bribery are in the law enforcement spotlight – both here in the U.S. and internationally. Between increasing U.S. Foreign Corrupt Practices Act enforcement, enactment of the United Kingdom’s new Bribery Act, and the efforts of the Organisation for Economic Co-operation and Development (OECD) to combat corruption globally, companies with international business must be sensitive to the changing business environment and the attendant risks and opportunities. It is time for all global businesses to review their anti-bribery and anti-corruption compliance efforts. This is particularly true in the pharmaceutical, device, and life sciences industries, given the numerous points of contact with government officials at virtually every point in a product’s life cycle and given that so many countries deliver health care through government-owned or operated systems.

One thing is certain – if your employees at every level, including on the front lines, are trained to be sensitive to bribery risks and anti-bribery laws, your organization gains significant protection in both actual bribery prevention and the ability to show evidence of systems intended to ensure compliance.

With respect to the new UK law, here are some key points to consider:

Persons are liable for either paying or receiving bribes. This is broader than the FCPA, which does not cover actual or potential recipients of bribes.

Bribery offenses can result from payments to virtually any and all persons with whom a company conducts business. Unlike the FCPA, the UK Act is not limited to payments made to foreign government officials.

Facilitation payments are technically bribes under the UK Act. Unlike the FCPA, the UK Act does not explicitly exempt facilitation payments. While such payments might not be prosecuted, it’s likely to be an area of risk with exposure depending on all relevant facts and circumstances.

Corporate liability can attach for the action of any “associated person.” A company is guilty of a bribery offense if a person “associated” with that company bribes another person, intending to obtain or retain business or an advantage in the conduct of business for that company. The definition of “associated” is not clear at the present moment, but the Act’s language is broad: “performs services” as “determined by a reference to all relevant circumstances.”

Senior Officers are liable for bribes committed with consent or connivance. A senior officer of a company covered by the UK Act (see below), will be liable for any bribery offense committed if they fail to demonstrate appropriate action once they became aware of the violation.

Companies can be held strictly liable for a failure to prevent bribery. It is an affirmative defense if a company can show that “adequate procedures” were in place to prevent bribery.  UK Act guidance on “adequate procedures” is under development, but preliminary guidance provides six broad management principles to “help relevant commercial organizations decide what bribery prevention procedures they can put in place.” See:  http://www.justice.gov.uk/consultations/briberyactconsultation.htm.

An offense is committed under the UK Act if: (1) any action or omission that constitutes part of the bribery offense occurs in the UK; or (2) the person/ company is closely connected to the UK.

Penalties imposed by the UK Serious Fraud Office can include: Unlimited fines for corporations and up to 10 years imprisonment for individuals.

Since governments around the world, and organizations like OECD and Transparency International, are focusing additional resources and attention on bribery and corruption, it makes sense for international businesses to evaluate existing compliance programs, assess gaps or weaknesses in those programs, and provide appropriate blended training solutions to close those gaps.  Paying attention to developments in enforcement and anti-bribery laws, regulations, and guidance and keeping all members of your organization up-to-date is critical.

Frances-Ann Moran
Executive Director, Compliance & Training Practice, Life Compliance Solutions, LLC
Partner at Life & Moran, LP

And

Kim Life
Executive Director, Life Sciences Practice, Life Compliance Solutions, LLC
Partner at Life & Moran, LP

The United States is leading the way toward increased transparency by life sciences companies and healthcare organizations. In recent years, six states have enacted legislation that requires certain life sciences companies to report details related to financial interactions with healthcare professionals and healthcare organizations. Some states have also imposed spend limits, constraints around such activities as in-office meals, and detailer registration and education requirements.

Then, in March 2010, President Obama signed the Patient Protection and Affordable Care Act (“PPACA”). Section 6002 of the PPACA embodies the Physician Payments Sunshine Act (“Sunshine Act”). This legislation, co-sponsored by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), requires drug, device, biologic, and medical supply companies to report a wide range of payments to physicians and teaching hospitals in all states. The first report is due March 31, 2013; it will cover data for the fiscal year 2012.

The Department of Justice’s Office of the Attorney General, FDA officials, and officials at the Office of the Inspector General of the Department of Health and Human Services have publically stated their goals for more investigations, higher fines, larger judgments, and longer sentences. Investigations, indictments, and penalties are increasing – they are doing what they say they would be doing.

Seven healthcare companies are already reporting healthcare professional spend data under settlement agreements with the government. Their data, analyzed and uploaded into a searchable database by ProPublica, a Pulitzer Prize winning news organization, and their media partners, has been the subject of a viral response. Companies, healthcare professionals, and patients alike have been shocked and embarrassed by some of the reports stemming from the data the companies disclosed.

The publication of spend data in 2013 under the Sunshine Act will only increase public and governmental scrutiny. In light of the furor created by the ProPublica disclosure, Massachusetts’ recently released spend data, and revitalized and energetic government investigation, life sciences companies are re-evaluating their technical and information requirements.

In-house compliance professionals are teaming with their learning and education colleagues to develop effective training that meets both the legal requirements and the company’s cultural requirements.

How this Impacts Your Existing Training Programs and Strategies

Life science companies need to take a fresh look at the content of their training programs, as well as the way compliance is trained in general. The government’s aggressive pursuit of civil and criminal cases against companies and employees in the industry, and the facts and circumstances of the big ticket cases to date, require a new approach.

Compliance professionals and their commercial colleagues realize that a few slides, charts, and frequently asked questions about the rules are not enough. The goal of any corporate education program (whether compliance or general operations focused) should be to change behavior for the betterment of the individual and the organization.

To achieve a truly effective learning program, the learning solution should be approached through these four steps:

1. Clarifying and documenting the end goals in clear and simple language
2. Identifying the knowledge required to meet these goals
3. Identifying what you want the participants to do that they do not do now
4. Identifying what you want them to absorb as part of their world view of the business and their role within it

The primary purpose of a robust corporate training program is not merely to prevent events that lead to fines and penalties. All training programs should strive to improve the business and its stakeholders to improve the bottom line. Yet this very principle is what many compliance training programs have left behind.

The new and existing federal and state transparency and disclosure legislation, and the crack-downs on fraud and abuse cases, give corporate training departments the motivation to boost their compliance training strategies with a healthy dose of commercial perspective. As companies work diligently and thoughtfully to build effective compliance systems and processes to comply and reduce risk, they should also take note of opportunities to develop and strengthen strategic relationships through the new compliance procedures.

Where Compliance Meets, Supports, and Improves Commercial

Undoubtedly, field employees and representatives will face questions and demands concerning the risks that healthcare professionals face in their relationship with the company; policy changes from the company, associations, institutions, and facilities; and fears of public and peer perceptions.  Also, Key Opinion Leader consultants must be prepared to explain the interpretations, policies, and procedures put in place by the company that have been designed to protect patients and the reputation of the consultant healthcare professional.

To successfully navigate the new field challenges and retain important relationships, training must go beyond charts and FAQ lists. Effective training must create a tangible understanding of the interpretations and processes that are designed to protect patients, the employer, and the healthcare professional under the new legislation. Training participants should be able to use their understanding to bolster the company’s objectives in other corporate programs – such as clinical research and healthcare professional education programs.

Training participants will be prepared to perform their tasks compliantly, and enhance and strengthen relationships, if they leave training:

1. Believing in the importance and integrity of the employer’s compliance goals and programs;
2. Understanding how their actions drive the process, and how the process may impact the healthcare professional, and why;
3. With the ability to effectively communicate these new understandings to healthcare professionals and other stakeholders in the field.