false claims act

Compliance News in Review, October 5, 2015

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CMS releases a new teaching hospital list and de minimis thresholds, ICD-10 is launched, New Hampshire investigates manufacturers of painkillers, and the UK Ministry of Justice reverses its position on expansion of the law.

It is fall y’all! Okay, so the stars and the calendar may have said fall arrived a couple of weeks back, but it just doesn’t seem real until we hit October. The air gets a little crisper, the leaves start changing, and we sadly reach that point when we hope against hope that we can make it through the night without turning the thermostat to “heat.”

Before you know it, all the pumpkins and scarecrows will give way to mistletoe and snowmen (insert collective groan here). Before we all run out for the annual jump into the pile of leaves, let’s grab a cup of cider and your favorite pumpkin spice treat, and review all the compliance news fit to blog, with this edition of the Compliance News in Review.

October first was quite a busy day! First, CMS released the teaching hospital list and de minimis thresholds for Open Payments. In 2016, payments to Covered Recipients of $10.22 or higher will have to be reported and the annual aggregate reporting threshold will be $102.99.

Second, Medicines Australia’s new transparency requirements went into effect. Even though the Code of Conduct was effective in May of this year, implementation of the new transparency requirements was delayed until October. One of the major changes in the transparency requirements was the requirement to report at an individual HCP level rather than in the aggregate.

Finally, October 1st was the “go live” date for ICD -10 (International Classification of Diseases, 10th edition). ICD-10 is the set of diagnostic and procedure codes used by healthcare providers to bill insurance providers and government healthcare programs. The transition to ICD-10 was mandated by the Centers for Medicare and Medicaid Services and is intended to provide more detail over the previous coding system. CMS says ICD-10 will help better “accommodate future healthcare needs, facilitating timely electronic processing of claims by reducing requests for additional information to providers.” While specificity can be a good thing, could ICD-10 be taking it a bit far? Check out some of the more unique codes in the new system. A couple of our favorites are “W56.22xA- Struck by an Orca, initial encounter,” (which apparently spawned a whole book) and “W49.01XA Hair causing external constriction, initial encounter,” also known as the Flynn Rider Code.

New Hampshire is turning a cold shoulder to opioid makers. The state’s Attorney General’s Office has announced it will be investigating the marketing practices of several manufacturers of painkillers. The AG’s Office believes the companies may have engaged in fraudulent marketing practices, which may have misled doctors and patients about the addiction risks and effectiveness of drugs.

The UK is changing its colors regarding expansion of the Bribery Act. Prosecutors had been petitioning to expand the law to make it easier to prosecute businesses involved in bribery, but in response to questions from lawmakers about the proposed changes, the Ministry of Justice said it was no longer interested in pursuing the matter. The response said there was “little evidence of corporate economic wrongdoing going unpunished.”

Conflicts or confluence – decisions, decisions. A recent editorial in the Journal of the American Medical Association (JAMA) makes a case for falling away from using the phrase “conflicts of interest” when describing the secondary interests involved in clinical research. The authors suggest “confluence of interest” instead. They say “conflicts of interest” automatically sets up the notion that something wrong is taking place. The authors point out that in academia, notoriety and fame could be a stronger influence on bias than financial reward. Universities, research institutes, the NIH and medical journals can all impact bias.

October has certainly started with a bang, in the world of physician spend transparency, both here in the U.S. and abroad. The news offers a good reminder that transparency and disclosure measures are constantly evolving. Yet another change will be upon us in 2016 with the removal of the exclusion for speaker of faculty payments for accredited CME.

With all of the changes in motion, now is a perfect time to refresh your company’s training on the requirements of the Sunshine Act and Open Payments. Ensuring your team is aware of the changes is critical, and those in the field need to understand the impact the law has on the healthcare providers they interact with on a regular basis.

That’s a wrap on this edition of the Compliance News in Review. Enjoy the cool weather everyone and have a great week!

CBI’s 9th Annual Forum on Transparency and Aggregate Spend: A Review

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CBI’s recent Forum on Transparency and Aggregate Spend covered a variety of topics affecting the collection and reporting of aggregate spend data. The conference featured speakers from industry, government agencies, and service providers sharing lessons learned and best practices related to aggregate spend collection and data disclosure.

After a day of pre-conference workshops, the main conference began on Day Two, and it started with a bang. The keynote address, An Update on Open Payments Reporting, was delivered by Doug Brown, CMS Group Director, Data Sharing and Partnership Group, Center for Program Integrity. Mr. Brown shared statistics on the data submitted for the 2014 reporting year. 11.4 million records were received, covering 600,000 individual physicians. In a vast improvement over the previous year, 98% of submitted records were accepted. Brown attributed this improvement to the introduction of the validated physicians list (VPL) and better data matching. An analysis of rejected records is underway, and CMS is looking for ways to improve the taxonomies associated with covered recipients.

During the review and dispute period, CMS received 30,000 disputes on 25,000 unique records. The disputes were evenly distributed among the covered recipient type, with physicians representing 35% of disputes, teaching hospitals 38% and principal investigators 27%. According to Brown, disputes were evenly split between the general and research payments reports. Very few disputes were lodged against payments reported on the ownership report. The median value of total payments is 4.5 times greater for registered physicians versus unregistered physicians.

Brown also shared information regarding the anticipated enhancements to the Open Payments system. The restrictions around special characters in the text fields will be removed (cue the heavenly choir). CMS is also working to better facilitate the review and dispute process. According to Brown, many of the disputes were not true disputes, but could better be classified as inquiries. CMS is working to provide a method for distinguishing between a payment inquiry and a payment dispute. The agency is also working to enhance the ability for manufacturers to download their data from the site, regardless of the file size, and it hopes to extend this capability to covered recipients as well.

Brown reminded the group that new de minimums payment information and the list of teaching hospitals will be released on October 1st. CMS is planning more Q&A teleconferences in the future. Speaking of which, during the Q&A period following the presentation, Brown was asked about having a moderator on teleconferences to alleviate the “wild west” that currently exists when the call opens up for participant questions. He said that was something he would absolutely consider, but he prefers the conversational style of the current format.

William Killian, U.S. Attorney for the Eastern District of Tennessee, and Jacob Elberg, Chief, Healthcare and Government Fraud Unit, of the U.S. Attorney’s Office for the District of New Jersey, also presented on behalf of the government. They discussed current trends in government enforcement. Mr. Killian said emerging enforcement trends in his and other offices involved fraud related to Medicare Part D, lab services, hospital services and hospice care. He noted that the civil and criminal prosecutors are often involved in parallel prosecutions. Mr. Elberg referenced a continuing trend in his office involving the prosecution of kickback cases. He said those cases are typically at the individual practitioner level, and occur locally or globally. Cases that involve activities outside the U.S. can implicate the FCPA and his office shares information with FCPA fraud units. Elberg also discussed other continuing trends involving FDCA prosecutions, including those involving off-label promotion and cGMP violations.

Rounding out the “law-focused” presentations for the day was a presentation about state laws by Brian Bohnenkamp of King & Spalding. Mr. Bohnenkamp led off by discussing federal pre-emption and how it relates to state reporting. He noted that there are times where the reportable items under federal law are not reportable under state law (and vice versa), and reminded the audience of the criteria for pre-emption under the Sunshine Act. He suggested that decisions on whether pre-emption should be applied to a particular payment should be made on a case-by-case basis. He also noted that they are seeing more companies take advantage of federal pre-emption in reporting under state laws, and used the example that a number of companies did not have anything to report under Minnesota’s law due to that pre-emption. Bohnenkemp also highlighted the recent exemption in D.C.’s detailer licensing requirement for individuals who are involved in detailing for “less than 30 consecutive days per calendar year,” and he reviewed prescription drug pricing transparency proposals in a handful of states – one example being Massachusetts, which still had not provided guidance about quarterly meal reports reported under that state’s law.

The majority of the rest of the Day Two sessions focused on data and processes directly related to interacting with the Open Payments system. Sessions and panel discussions covered topics such as leveraging the data within the organization; using data to minimize compliance risk; and remediating data and the data attestation in Open Payments. Two key themes emerged: 1. Clean data is key (the garbage in garbage out idea) and 2. Communication with the organization and those outside the organization (your vendors and physicians) about the data is critical.

A number of speakers and panelists in the sessions stressed the importance of consistency in names, addresses, and format for physician ID numbers across the various in-house and vendor systems that house spend data. A periodic review of the data is an important best practice to deal with any issues along the way. Most panelists and speakers felt that a quarterly review was an achievable goal. More frequent reviews would be ideal, but could prove a challenge for companies with fewer resources. In addition, companies should engage the business early and often about what the data reveals and how that information can be leveraged to reduce risk and impact sales. Communication with physicians in advance of the CMS review and dispute period was recommended. This does not necessarily mean disclosing all the data, nor pre-disclosing to every physician about whom you have data. Setting a minimum TOV threshold for pre-disclosure, or pre-disclosing only to select KOLs were suggested as means of making the pre-disclosure beneficial to both the physician and the company.

Speaking of physicians, Day Two included a panel discussion moderated by PhRMA Executive Vice President and General Counsel, John Murphy, on the physician’s perspective of Open Payments. Panelists included Dr. Maya Babu of the Mayo Clinic and AMA Board of Trustees member, and Dr. David Barbe, former Chair and current member of the AMA Board of Trustees. The panelists said the main concerns of physicians are centered on the potential for bad data being presented to public, the ability for physicians to access the data, the implications of the data, and the impact the Open Payments program will have on relationships with the industry. While there have been improvements in the registration process, there are still issues with access, specifically, problems with particular browsers being able to access the site. The panelists felt strongly that being able to access the data through a site set up by the manufacturer would be helpful, or even having a sales rep provide the data personally.

The United States certainly hasn’t cornered the market on physician spend transparency. Global transparency was addressed on Day Two, predominately in a discussion group at the end of the day. On Day Three an entire morning track was dedicated to issues related to global transparency. The featured presentation (and highlight of the conference) was an address by Andrew Powrie-Smith, Director of Communication for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Mr. Powrie-Smith briefly covered the nuts and bolts of the EFPIA Disclosure Code before turning to a discussion of transparency in general. The industry believes transparency is about demonstrating that there is value in the collaboration between industry and healthcare professionals/organizations, which ultimately delivers better patient care. However, being transparent is not without its challenges. Primarily, with the exception of countries, such as France, where there are physician spend disclosure laws, managing transparency efforts in face of the EU privacy laws is challenging. The EFPIA Disclosure Code requires the disclosure of certain transfers of value at the individual practitioner level, and requires that disclosure to be made available to the public. In order to meet these requirements, companies must obtain consent from physicians to disclose private information about them. Further complicating the matter is that even if consent is given, it can be revoked at any time.

Mr. Powrie-Smith said EFPIA is currently conducting a survey regarding the industry stance on obtaining the necessary consents for disclosure of transfers of value at the individual level. Thus far, EFPIA has seen a large variance in the rate of consent across Europe. A culture shift is necessary to address the variance and the industry must take a leadership role in that shift.

The concept of gaining and managing consent was emphasized in other presentations as well. Representatives from BMI Systems shared data on the rates of consent presented by various pharmaceutical industry trade organizations at an EFPIA meeting in May. In Germany, the consent rate was 50-55%, and the industry trade organization in the country said that was about what they expected for the first year. Poland’s trade organization noted in March they were at a 20% consent rate, and Spain’s trade organization reports only a 10% consent rate. Representatives from IMS Health dug into issues with gaining consent as well. They discussed how codes and laws differed from country to country, specifically regarding the timelines for obtaining consent (e.g., at time of contract, or at any time during the reporting period); the scope of the consent (e.g., per activity type, per contract); from whom consent is required (e.g., HCPs or HCOs); and required consent documentation (paper or digital).

The 9th Annual Forum on Aggregate Spend and Transparency offered useful information for any attendee responsible for data collection, report submission, or analytics inside or outside the U.S. Beyond the nuts and bolts of aggregate spend, the presentations focused on the value of the data for the organization and the physician. Data provides insight for commercial teams and their programs, and the compliance risks for the company. Most importantly, as communicated by Andrew Powrie-Smith, transparency around spend data is important, because it reveals the benefits of the industry/HCP relationship to patients, payers and the public.

 

News in Review, August 11, 2015

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Industry support of CME increases in 2014,  NuVasive settles False Claims charges while Mead Johnson deals with FCPA charges, and Amarin wins a preliminary injunction in its off-label case against the FDA.

The dog days of summer have certainly arrived in most of the U.S. with temperatures that are best described as hot, hot, hot! Thanks to Willis Carrier and his wonderful invention, we can at least find occasional respite from the sun’s rays and the humidity. So while you wait for a break in the heatwave, crank the A/C up a few notches, grab a cool beverage, and just chill with this edition of the Compliance News in Review.

According to a report from the Accreditation Council for Continuing Medical Education (ACCME), industry support of CME increased 2.4% in 2014. According to the report, industry support represented about a quarter of all CME revenue in 2014, whereas in 2007, that support was closer to half (46%) of CME revenue. Physician attendance at CME dropped by just over one percent, but non-physician attendance rose six percent.

The heat is off for NuVasive now that it has settled with the DOJ. The company has agreed to pay $13.5 million to settle charges it violated the False Claims Act by marketing a product for surgical uses for which it was not approved. According to the government, the company marketed its CoRoent System for several spinal surgical procedures for which it was not approved. The DOJ also claimed kickbacks, in the form of speaker fees honoraria, were paid to induce physicians to use the system. The company was also accused of paying kickbacks for physicians to attend events hosted by Society of Lateral Access Surgery (SOLAS), an organization that was entirely organized and funded by NuVasive.

Mead Johnson entered into a settlement with the SEC to resolve charges it bribed Chinese government healthcare workers to recommend its infant formula, in violation of the FCPA. According to the SEC, the company funded the payments through distributor allowance funds paid to a third-party distributor, and then directed the third-party on how those funds were to be used. Allegedly, the payments were not properly reflected in the company’s books and records.

Insys also finds itself in the doghouse; or in this case, we’ll say the duck house (okay, it’s a reach, but stay with us here). Insys Therapeutics has entered into a settlement with Oregon to resolve a deceptive marketing case. The State claims the company marketed an opioid painkiller for treating mild pain that was only approved for treating pain in cancer patients who are not responding to other types of painkillers. The State also claims the company paid physicians for writing prescriptions and used unqualified physicians to promote the product. The settlement will be split between the State and an organization dedicated to the prevention of opioid abuse, which will be selected by Oregon’s Attorney General.

So it appears, this off-label promotion dog can hunt. Amarin, the company suing the FDA over its ability to promote its fish-oil drug for off-label uses, has won a preliminary injunction against the agency. The injunction is not a final order, but for now, the FDA cannot prevent Amarin from the truthful off-label promotion of its product. The drug is approved for treating patients with very high levels of triglycerides. Amarin would like to promote the drug for use with patients that have moderately elevated triglycerides levels, despite being on a statin.

Like the Caronia decision before it, the Amarin case certainly raises interesting questions about the future of truthful off-label promotion. While a compliance training session may not be the place and time to delve into a discussion of that future, the decision does present an opportunity to discuss off-label promotion and how to address questions related to off-label use. Why not take this opportunity to launch refresher training, or distribute an updated, quick-reference communication piece? On-going reminders about what constitutes off-label promotion, and the policies your organization has in place to address unsolicited questions, are part of any effective compliance curriculum. The case also creates an opportunity to work with commercial team managers on a plan to increase the dialogue about the topic with their teams. Off-label is in the news and the training opportunities abound.

Compliance News in Review, July 20, 2015

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The House of Representatives passes the 21st Century Cures Act, two companies settle AMP charges, oral arguments begin in Amarin v. FDA, and CMS updates its Open Payments FAQs.

Diamonds are not only a girl’s best friend…a very special mouse is fond of them as well. The Happiest Place on Earth (or, at least the one in California), is celebrating its diamond anniversary. Happy 60th Disneyland! The place has certainly changed in its 60 years, but fan favorites such as Mr. Toad’s Wild Ride and the Jungle Cruise have stood the test of time. In true Disney fashion, the party isn’t just a one day affair; it actually started back in May and will likely continue through the fall, if not into 2017. Before we cut the cake with the big ears, we have a bit of “magic” of own to administer. Grab a churro and settle in for this edition of the Compliance News in Review.

The House is celebrating the overwhelming passage of the 21st Century Cures Act. The bill is designed to fund research and change the FDA’s drug and device approval process. It includes a change to the rule its provisions are changes to the Sunshine Act which would exclude the reporting of the value of journal reprints and payments for CME.

AstraZeneca and Cephalon may be feeling a bit Grumpy. The two companies reached separate agreements with the government over charges related to underpaid Medicaid rebates. According to a whistleblower, the companies improperly reduced the Average Manufacturers Price (AMP) of their products by subtracting fees paid to wholesalers. The companies paid $46.5 million and $7.5 million respectively to settle the matter.

Oral arguments began in Amarin’s suit against the FDA. The company cited the Caronia decision and the Sorrell v. IMS decision in its argument. Much of the discussion centered on the type of disclaimers need to accompany off-label promotion and not whether Amarin even has a right to do so. The FDA’s lawyer argued the interpretation of the Caronia decision should be very narrow but the judge disagreed. A judicial order is expected in a few weeks.

The whistleblower in a case against Endo may be throwing a Mad Tea Party now that she’s been awarded $33.6 million for her efforts. The case, which was settled with the government in February of last year, involved the off-label promotion of the company’s pain patch. Despite a recommendation from government lawyers that the whistleblower receive 19% of the settlement, the federal judge awarded her 24%, citing her “extraordinary effort” in the case. The whistleblower initially filed suit in 2005, and spent five of the nine years that followed working under the direction of the FBI.

CMS has sprinkled some Pixie Dust over the Open Payments FAQs, and sure enough new FAQs have taken flight. Several of the new FAQs have to do with physicians and teaching hospitals being able to access, review and dispute the data now that the review and dispute period has closed.

If the FAQ updates weren’t enough, CMS was back for a second ride with updated information about the reporting of CME payments on the Law and Policy page of the Open Payments website. Beginning in 2016, manufacturers will have to report indirect payments to CME providers if the manufacturers learn the identity of the physician attendees or speakers within the reporting year, or the first two quarters following the reporting year.

The updates to the Open Payments website remind us that the program is evolving. Your company’s training needs to evolve and grow as well. Affected personnel need to be updated on changes, and reminded of the need to communicate with their physicians. Now is the time to map out your plan for refresher training and refocus your aggregate spend and sales personnel.

That’s a wrap on the compliance news fit to blog for now. Have a great week everyone.

 

 

Compliance News in Review, May 27, 2015

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Legislation nullifying the need to report payments associated with CME moves to the House of Representatives for a vote, a new article in the NEJM offers thought proving insight on the relationship between industry and physicians, and OPDP issues untitled letters to two pharmaceutical manufacturers.

The monotonous strains of Pomp and Circumstance fill the air…graduation season is here! From kindergarten to college, students are donning caps, gowns, cords and stoles in celebration of their academic achievement. If you happen to have a student crossing the graduation stage this spring/summer, congratulations! We hope the commencement address is at least as thought provoking as this one. While you’re sitting there waiting for your loved one’s name to be announced, feel free to fill the time with this edition of the Compliance News in Review.

The 21st Century Cures Bill graduates from the House Energy and Commerce Committee and moves on to a vote by the whole House. The legislation aims to improve healthcare through support for research and development and by streamlining regulations. If passed, the law would nullify the requirement for reporting payments associated with CME; require the FDA to provide guidance on the sharing of health economic information; and require the FDA to issue guidance on the sharing of truthful, not misleading scientific information about off-label uses of drugs.

A new article in the New England Journal of Medicine explores the relationship between physicians and the industry. The article suggests the need for a reasoned approach when addressing conflicts of interest. The author acknowledges that conflicts exist, but that there are benefits to the physician industry relationship that shouldn’t be discarded simply because such relationships with industry are perceived as a negative.

Over a period of five days, the Office of Prescription Drug Promotion (OPDP) issued two untitled letters. Until this point, the agency had issued only four letters this year. The first letter, issued to Oak Pharmaceuticals, dealt with misleading statements on an exhibit banner. The statements did not include information about risks or material information about the approved indication of the product. According to OPDP, the only reference to prescribing and safety information on the banner was a directive to talk to a representative at the company’s booth.

The second letter was issued to Actavis over misleading statements on a Watson Pharmaceutical product webpage. The OPDP said the webpage was misleading because it contained unsubstantiated claims. The agency cited a specific marketing statement indicating the drug would help with conditions (sleep disturbance and work productivity) for which there was no evidence in the clinical studies.

When training about promotional speech, life sciences companies often focus on off-label statements, and with good reason. Off-label promotion continues to be a dominant issue in False Claims Act cases. However, other promotional speech issues should not be ignored or forgotten. The OPDP has least one letter every month so far in 2015. Additionally, the agency continues to dedicate considerable resources to educate healthcare providers about its Bad Ad program. That’s why promotional speech training needs to go beyond off-label, and address the need for company representatives to present the benefits and the risks of the products they promote.

Enjoy the week everyone!

Week in Review, April 27, 2015

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Teva settles a pay-for-delay case, the FDA migrates toward electronic submission of promotional materials, a circuit court rejects off-label claims against Medtronic, and several states introduce legislation requiring drug makers to release the costs associated with expensive drugs.

Lordy, lordy, King Arthur is Forty! Monty Python’s version of King Arthur that is. The comedy classic, Monty Python and the Holy Grail, is celebrating its 40th anniversary. If you’re not familiar with the film, forget what you think you know about King Arthur’s quest for the Holy Grail. This version certainly reveals a side to Arthur, his Knights and life in medieval Britain that has never been explored. Whilst we consider the merits of this classic comedic cinematic achievement, we’ll leave you with an epic tale of our own. To horse fine people…it is time for the Compliance News in Review.

Now this is a lot of coconuts. Teva has agreed to pay $512 million to settle a pay-for-delay case involving its Cephalon subsidiary. Drug wholesalers and retailers accused the company of paying generic drug makers to delay marketing a generic version of Provigil. The settlement is the largest in a pay-for-delay case.

The FDA has released new guidance that will make it easier for drug companies to submit promotional materials to the Office of Prescription Drug Promotion (OPDP). Currently, companies are required to submit promotional pieces through a paper-based process, using form FDA-2253. The new guidance offers instructions for submitting promotional materials using the FDA’s electronic common technical document (eCTD). The use of eCTD was mandated in the Food and Drug Administration Safety and Innovation Act. According to the guidance, in two years, all promotional materials must be submitted electronically.

They don’t have a shrubbery, but they would still like safe harbor. The National Infusion Care Association (NICA) has issued a paper arguing that OIG’s position stating that co-payment coupons and other financial assistance runs afoul of the Anti-kickback Statute (AKS) should not apply to specialty biologics for which there is no generic available. The OIG issued a report saying the coupons could be problematic under the AKS if they entice a patient to purchase a drug that is paid for by the government. NICA says while well intentioned, the position is really only valid if there is a generic alternative available for a specific drug. The organization claims that for many specialty biologics, no such alternative exists, and they worry that patients on government programs could be left with few treatment options if they are not able to accept co-payment coupons offered by manufacturers. NICA would like to see CMS, HHS, OIG and others in the government create a safe harbor allowing those on government programs to participate in co-payment programs if there is no generic alternative.

It may not have had the same drama as the process for determining if someone is a witch, but a circuit court has rejected claims against Medtronic over its off-label promotion of a medical device. The company was sued by an Oklahoma woman who said her physician implanted the product, Infuse, in a manner that was different than the FDA-approved approach. The woman said her doctor was urged to by a Medtronic representative to use the particular approach, and that the company had violated state tort laws. The court said her claims either did not have sufficient proof or were pre-empted by federal law.

Several states will soon be asking drug companies to bring out their drug costs. Massachusetts, North Carolina and Pennsylvania are the latest states to introduce legislation requiring manufacturers to disclose the costs and pricing information associated with expensive drugs. The Massachusetts’s bill will impose a limit on what a company can charge if the state determines the price of a drug is “significantly high.” If that bill is passed, the state will develop a list of drugs for which reporting is required. Companies will have to report costs related to production, research and development, and marketing. North Carolina’s law will require disclosure reports on all drugs sold in the state, and like Massachusetts, the production, research and marketing costs will have to be reported. Pennsylvania’s law will require disclosure reports for drugs with an average wholesale price of $5,000.00 or more, annually or per treatment. The Pennsylvania bill allows insurance companies and state programs to not cover a drug if the manufacturer has not filed a transparency report with the state.

With that, our tale for this week has nearly ended dear readers. We leave you with the reminder that many knights prefer accessing up-to-date compliance training whilst jousting about on horseback rather than hoping for a strong wireless connection over a mug of mead at the local tavern. The PharmaCertify™ suite of compliance-focused training solutions offers that training where your knights need it most – beyond the round table and at their fingertips.

Farewell for now dear friends.

Week in Review, April 21, 2015

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CMS tries to clarify the Open Payments review and dispute process, GSK considers changing its compensation program, and a Florida pharmaceutical manufacturing company is charges with selling unapproved products.

April showers bring May flowers, or so the saying goes. Well if you live in the southeast or northeast corner of the country, it will apparently be an extra flowery May. Rain, rain and more rain has fallen over a good chunk of the country. While that rain is certainly a good thing, the accompanying flooding isn’t. Luckily, sunny weather is on the way according to the pundits and folks can dry out. As we wait for those flowers dry out enough to bloom, we’ll rain some compliance information down on you in this week’s Compliance News in Review.

The Sunshine is back out over the medical community, but the mood is a little gloomy. CMS held a conference call for reportable recipients under the Sunshine Act to discuss the Open Payments review and dispute process. CMS reiterated its stance, that it will not intervene in disputes, but will be monitoring the process. The agency is particularly interested in the number of disputes that are initiated and how many remain unresolved. Reportable recipients expressed frustration that there was not enough context or consistency among manufacturers in how payments are classified under the “nature of payment.” This makes it difficult for reportable recipients to determine whether a payment is correct. CMS said input from all parties would be required before any changes are made.

The winds of change are blowing for GSK and its sales rep compensation structure…again. A task force has been put in place to examine how to simplify the company’s “Patient First” program. The current program establishes bonuses on factors such as product knowledge and understanding the needs of patients and doctors, rather than prescription numbers. A GSK spokesperson says the company remains committed to their commercial model, and while the company has looked for ways to simplify the program in other countries, the fundamentals of the program remain the same.

There’s been no singing in the rain for Florida based Stratus Pharmaceuticals. The distributor had $1.5 million in unapproved drugs seized by U.S. Marshals. The confiscation of the drugs came at the request of the FDA and U.S. Attorney for the Southern Florida District. According to the FDA, Stratus was marketing and distributing a number of unapproved drugs, including an antibiotic skin cleanser, a topical cream to treat psoriasis and eczema, and a topical ointment for treating wounds. The drugs were manufactured by Sonar Products of New Jersey.

With that, we bring this rain-soaked edition of the News in Review to a close. Remember, if the winds of change are long overdue for your compliance training curriculum, the PharmaCertify™ suite of customizable compliance solutions offers the up-to-date training where your learners need it most – in the field and at their fingertips.

Have a safe (and dry) week everyone!

News Week in Review, April 13, 2015

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Spain and Malaysia amend their anticorruption laws, researchers from the NIH say the government rules on paperwork and travel are too complex, and India considers dedicated oversight for medical device.

Golf voices and claps only, please. It’s time to celebrate the greenest spectacle in sports – the Masters. The lush fairways, that somewhat disturbing green jacket and we can’t forget the green ($10M total) won by the top players. This year’s event saw the return of Tiger Woods, Jack Nicklaus making a career first hole-in-one at the Par 3 tournament, and the record breaking victory by Jason Spieth. Now that the drama is over and the young man from Texas held off the field, it’s time to tee off on this week’s Compliance News in Review.

A pair of countries legislating compliance programs are the first on the tee this week. At the end of March, the Spanish Congress approved amendments to its Criminal Code, which requires companies to adopt a compliance program. The change is effective as of July 1, 2015. According to the law, compliance programs must be supervised by a group or individual that can exercise a high level of control. The law provides a company protection from criminal prosecution when the company’s compliance program when the individuals responsible for the compliance program did not neglect their duties. It also details six element’s that must be included in order for the company to be protected from prosecution.

Malaysia’s Attorney General wants to amend country’s current anticorruption law to address corporate liability. A deputy with the Malaysian Anticorruption Commission (MACC) said the U.K. Bribery Act and FCPA were being used as guidelines for the Malaysian law.

Medical researchers from the National Institutes of Health (NIH) would like a mulligan, of sorts, on the paperwork required for travel to attend medical conferences. Researchers say the government’s paperwork and travel approval process is time consuming and is hurting science and it can take up to six months to learn whether they’ve been approved to travel to conferences and meetings. The strict rules were put in place following a scandal involving travel at the General Services Administration. One researcher said he had to turn down a speaking request at a popular conference because the agency has to limit how many individuals it sends to any one event, and he is often passed over as a speaker because conference organizers don’t believe he’ll be able to attend. The NIH spent over $14 million in oversight of travel and expenses in 2014, which was nearly a quarter of its total travel budget for the year.

India is bringing medical device oversight on par with how drugs are regulated. A government task force is recommending a separate regulator be put in place to oversee safety and price controls of diagnostic equipment, implants and hospital equipment. Currently, devices are regulated under the same act as drugs, but both industry and public health advocates have argued that devices are different and should be regulated under different rules.

With that, we put a bow on another year of the “tradition unlike any other,” and another edition of the Compliance News in Reviews. Have a great week everyone, and as you hit the greens this year, remember the words of the late, great Paul Harvey, “golf is a game in which you yell ‘fore,’ shoot six, and write down five.”

Week in Review, April 6, 2015

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West Virginia repeals its disclosure law, Connecticut modifies its requirements for insurance coverage related to off-label use, two whistleblowers file a suit against Teva, and tighter transparency rules are debated in New Zealand.

Spring has sprung! Woo hoo! Since a number of us “enjoyed” up to 5 inches of snow on the first day official of spring, a break from the drudgery of the bitter temperatures is well-deserved, nay, warranted. The compliance news doesn’t take a break though, so for now, we’ll put our visions of sand castles and sea gulls to the side and focus on all the news fit for blogging, with this week’s Compliance News in Review.

It seems there’s no vacation when it comes to state transparency laws. The governor of West Virginia has approved a bill that will repeal the State’s requirement for pharma companies to report drug advertising and promotion expenses. Expenditures for 2014 are due in April, but the repeal will end the reporting requirement from January 1, 2015 forward. The GOHELP organization has not publicly published advertising expenditures reports since 2010.

Consumers in Connecticut could be getting a break when obtaining medications for off-label uses. A modification to the state’s current law will increase insurance coverage of drugs prescribed for off-label uses. The current law requires off-label coverage if the drug appears in one of three specific medical compendia. Unfortunately, two of the references are no longer published. The revision to the law would require coverage if significant information in peer-reviewed publications support the off-label use.

BioChemics was ordered to pay over $17 million to settle investor fraud charges brought by the SEC. The SEC says the company lied to investors about its research, FDA communications, and status of clinical trials, and provided false valuations for the company. The company collected over $9M from 70 investors. The judgement supplements another judgement against the company’s founder and two promoters from earlier in the month.

Party crashers? A new survey shows securities fraud class action suits against life sciences companies are on the rise. In 2013, there were 19 suits against life science companies. In 2014 that number rose to 39, and represented 23% of all securities fraud cases for the year. Most of the defendants were smaller companies.

Green is the color of spring, and apparently the color of honorarium envelopes at Teva, according to two former sales reps. A whistleblower suit filed against the company claims that Teva engaged in sham consulting arrangements in order to boost prescriptions of Copaxone and Azilect. The two claim that doctors were only allowed to remain speakers for the company if they increased the number of prescriptions written for covered drugs, and that the content of the programs had very little educational value.

The “sunshine” is shining bright in New Zealand, even though they are celebrating the fall season there. In a recent New Zealand Medical Journal article, transparency advocates made an appeal for a U.S. style Sunshine Act. The authors argue that while disclosure requirements are being tightened in other countries, the situation remains “murky” in New Zealand, where doctors receive remuneration for a variety of services, and sponsorship for accommodations and travel to conferences. One of the authors has spoken out about the topic in the past, and has been critical of Medicines New Zealand for its lack of transparency regarding the disclosure of physician payments. While not outright dismissing the idea, Medicines New Zealand has stated that adding disclosure requirements would be complex and require a significant amount of resources.

With that, we close out this spring season edition of the Compliance News in Review. Speaking of sunshine, as transparency requirements grow around the world, the PharmaCertify suite of training solutions offers your learners the content they need to navigate the cloudy world of pharmaceutical compliance reporting regulations.

Have a great week everyone!

The 2015 Pharmaceutical Compliance Congress: A Review and Recap

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The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array of content was covered, the focus often turned to two key topics – Speaker Programs and the FCPA.

Day 1

The conference kicked off with a keynote speech from Michael Shaw, Vice President and Chief Compliance Officer for GlaxoSmithKline. Shaw’s presentation was focused on the idea that instilling a culture of compliance is not enough in today’s regulatory environment. He emphasized the importance of ‘explaining the why’ behind the values, and the need to hold individuals accountable for compliance. As an example, at GSK, while Compliance is responsible for facilitating the process, Brand Directors are held accountable for managing the risk. As Shaw says, “compliance programs are important, but they’re not enough. The elements of the programs need to have traction.”

Otsuka ‘s Regina Gore Cavaliere and Brian Miller showcased their use of humor as a core tool for compliance training. Cavaliere and Miller have integrated a variety of creative elements, including a mock mini-series called The Pharm, comic books, and live talk shows, into their curriculum to keep the training fresh and appealing. Much of what was presented was indeed witty and engaging, and it showed that comedy can clearly be an effective tool when developed professionally and integrated carefully into a blended campaign.

In the Chief Compliance Officer Panel titled, Working with the Business – Ensure Compliance Adds Value to Operational Success, Jeffrey Rosenbaum from Vertex, Sujata Dayal from J&J, and Sumita Ray from Pharmacyclics, offered their perspectives on the keys to an effective program. With limited resources and time, Rosenbaum starts with his company’s business objectives while managing the issues with the highest risks. Ray agreed, saying she evaluates what risks she has to address on a daily basis, making training her first priority. As part of a large global company, Dayal begins with a formal risk assessment and conducts testing on a regular basis to ensure that mitigation is working. Rosenbaum also emphasized the importance of recruiting allies in the company when resources are stretched, as with Sunshine Act reporting, while Ray echoed Michael Shaw’s points about the importance of holding businesses accountable for their actions and results.

The presentations shifted to a governmental and regulator’s perspective with Doug Brown from CMS updating the audience on the state of Open Payments, a panel of US Attorneys addressing trends and top priorities in healthcare enforcement, and Andrew Ceresney, Director of Enforcement at the SEC covering disclosure issues relevant to the pharmaceutical industry.

What stood out during the enforcement panel was the increased amount of cases the regulators are seeing involving small to mid-size companies. Greg Shapiro, from the District of Massachusetts added that the audience should expect to see more criminal liability with those cases. Jacob Elberg, from the District of New Jersey encouraged those who identify a problem to self-report since “it sends the right message to employees and regulators.” More than one panel member delved into the risks of Speaker Programs, with Shapiro calling them “areas prone for abuse” and William Killian from Tennessee reminding the audience that Speaker Programs must not be tied to any promotion of business.

Ceresney covered the FCPA and the risks particular to the pharmaceutical industry. According to Ceresney, the SEC is focusing on three enforcement areas: pay to prescribe, pay to get on formularies, and charitable contributions. He emphasized the need for risk assessments and training, and the need to take measures when issues are identified.

After lunch, the sessions were divided into smaller groups, and I opted to stay with the FCPA theme in the session titled, Strengthen your FCPA Compliance through Smarter Training. David Nicoli, former VP, Corporate Affairs, AstraZeneca, and a panel of vendors walked through the steps they consider to be crucial when training on the FCPA. Collaboration is key, Nicoli claimed, and during his tenure at AZ he partnered on training initiatives with key allies, such as the Heads of Human Resources and Social Responsibility, who truly understand the work environment. The panel stressed the need for short, quick hits in FCPA training, and the fact that bad decisions make for good stories that stick in learners’ minds.

After the FCPA session, I jumped into the track dedicated to Product Promotional Compliance. Paul Silver from Huron presented statistics from a recent industry survey on company interactions with HCPs. For example, 86% of companies reimburse for HCP travel time and 1/3 of the companies surveyed have a limit on hotel expenses. Overall, the statistics presented a strong baseline for how the industry handles HCP travel time and I highly recommend the data for those interested in knowing what their peers are doing.

The session on overseeing the relationships between Sales, MSLs, and Managed Care Reps, was highlighted by one powerful statement from Kevin Stark, Director of GHH Compliance, at Merck, which could be considered a compelling theme for the entire conference, “build a culture where it’s okay for people to admit when they made a mistake.”

Day 2

The second day opened with Tom Abrams of the FDA and his annual update on enforcement trends at the Office of Prescription Drug Marketing. In the area of policy and guidance development, OPDP has released six draft documents since January 2014, and three draft guidance documents on social media.

Abrams’ agency continues to allocate resources and priorities based on potential threats to public health. The most common violations over the past year were related to omission and minimization of risks, and unsubstantiated superiority claims.

Day 2’s enforcement panel, titled, A View from the Outside —Mitigate Risk and Prepare for the Future featured a panel of defense attorneys well-versed in the areas of risk for small and large pharmaceutical companies. Scott Lieberman of Loeb and Loeb stressed the need for sales representatives to know exactly how to handle off-label questions when dealing with HCPs. Matthew O’Connor, of Covington & Burling warned smaller companies to allocate enough resources to monitoring, an area often neglected. When asked about the relationship between Compliance and Legal, Allison Shuren from Arnold & Porter said Compliance should be the “boots on the ground, moving issues up the food chain,” and John Richter, from King & Spalding, noted that Compliance should be ‘setting the policy and evaluating the balance between costs and risks.’

I was particularly interested in the Life After a CIA — Impact on Internal Team Structures and Resource Allocation panel, so I attended the breakout session: Compliance Program Structure and Effectiveness.

Sujata Dayal, from J&J, stressed the need to continue the conversation between the businesses and Compliance but that dialogue needs to change as the role of the business shifts from one in which the businesses mandates company priorities to one in which they influence actions and decisions. Gregory Beeman, from Eli Lilly, said the first step was to see what can be streamlined and continued post-CIA. In other words, what was under OIG oversight that could be eliminated now that the CIA has expired?

In Successful Promotional Programs — How to Use Data Analysis & Market Research to Drive Compliant, Effective Results, Mark Dizon from Actelion, and David Gilman from Huron led a spirited discussion on the use of data and analytics to assess risks and results of Speaker Programs. The idea of whether Speaker Programs should be evaluated against Return on Investment was of particular interest as audience members and the panel members debated the merits and risks associated with acknowledgement of the ROI.

The final session I attended was focused on the challenges faced by small to mid-size businesses as they struggle to allocate compliance resources. The panel, consisting of Timothy Ayers of Porzio, Bromberg & Newman, Katrina Church of Merz North America, Jeff Rosenbaum from Vertex, Sarah Whipple from Aegerion, and Greg Moss from Kadmon, offered a diverse set of best practices based on their experiences with limited resources and time. The perspective offered by those who are literally ‘departments of one,’ and those, like Church from Merz, whose departments are growing rapidly, had enough content, suggestions, and tips to fill a conference unto itself. As one example, the panel and audience debated the benefits and challenges of live training versus eLearning. While live training offers the opportunity to work face-to-face with each trainee, which is easily achieved in very small companies, Church was quick to point out that as Merz grew, a shift to more eLearning, with its streamlined tracking, became a necessity. And, like their colleagues from larger companies, these participants emphasized the need to include the Board of Directors and the C-Suite in the importance of compliance training; and in getting buy-in at all levels of the company.

To sum up, the details brought forth over two days by many well thought out presentations and panel sessions in this year’s Pharmaceutical Compliance Congress offered veteran attendees and new comers alike a wealth of practical and impactful information, making attendance not only a good idea, but crucially important to staying abreast of new developments and best practices in life sciences compliance.