fair balance

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 10, 2015

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The government targets Novartis for False Claims violations, pharmaceutical companies map out a plan to keep medication flowing into Greece throughout the crisis, and the industry as a whole ponders the impact of the CMS release of 2014 transparency data.

The days are long and lazy – it’s time for summer vacation! From the beach, to the mountains to foreign destinations, the News in Review staff is finalizing plans for summer R&R. Rest assured though, we are still hard at work keeping up with all the compliance news fit to blog, starting with this sun splashed edition of the Compliance News in Review.

The Justice Department and 11 states are putting a dent in the Novartis vacation account with a $3.4 billion charge for damages and fines in a False Claims Act case involving kickbacks to pharmacies. According to prosecutors, the company offered rebate and discount programs to pharmacies in exchange for increased prescriptions of two drugs. Novartis disputes the allegations and says it will continue to defend itself. A trial has been set for November.

Pharma companies are mapping out a plan to keep medication rolling into Greece. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the complexity and fragmented nature of the Greek medicine supply chain makes the flow of medication vulnerable. Pfizer, Roche and Novartis said they have plans to ease any shortages during the crisis, and AstraZeneca and GSK have both said they are drawing up contingency plans to keep medicines in supply.

CMS and agg spend folks are probably ready for a break in their routine now that the 2014 Open Payments data has been published. The data shows that companies paid physicians almost $6.5 billion for the year, with over 11 million transactions reported. Research payments topped the list with over $3 billion paid, there were $2.5 billion in general payments and $700K was reported on the ownership reports. CMS was able to validate close to 99% of records submitted to the system, which is a vast improvement over the 2013 data. As was the case in 2014, the majority of the reported payments were small. Sixty-six percent were for payments of less than $20. Research and royalty payments represented the largest dollar amounts.

Once the Open Payments data was released, the numbers quickly found their way into the media. The focus on payments to physician and the influence those payments have on prescribing decisions and healthcare at large is at an all-time high. That level of scrutiny highlights the need for training on the Sunshine Act and Open Payments – especially for those interacting with HCPs. While much of the work related to the reporting requirements is a “back office” function, those interacting with HCPs are often the first to hear concerns from the field and they need to be prepared.

In addition, the public release of the data opens companies to examination of their business practices from whistleblowers and enforcement agencies. Critical evaluation of training is important. Are all the appropriate audiences being covered? Is the training up to date? Is a refresher required? Regular audits of training curriculums and plans are key to reducing the risk of questionable payments, and could spare the company expensive costs down the road.

Have a great weekend!

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.

Compliance News in Review, March 24, 2015

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Oregon considers the idea of requiring pharma companies to disclose pricing information, CMS offers Open Payments updates, Sandoz settles with the OIG over alleged pricing data misrepresentations, the DOJ beefs up its FCPA enforcement team, and Public Citizen petitions the FDA on the issue of companies distributing peer-reviewed articles.

It’s time to dance everyone! March Madness is here. And what a dance it has been so far. As per usual, a couple of Cinderella moments wreaked havoc on brackets far and wide. Now it is onto the Sweet 16. Is your team still in the mix? While there’s a momentary break in the action, let’s take a look at the stories that filled our dance card this past week. Time to tipoff this week’s Compliance News in Review.

Our first story takes us to the home of the Oregon Ducks. Perhaps taking a cue from its neighbor to the south, a bill has been introduced in the Oregon legislature to require pharmaceutical companies to disclose information related to drug pricing. California introduced similar legislation recently, and like the California proposal, Oregon’s proposal would apply to drugs with an annual wholesale acquisition cost of $10,000. Companies would be required to file an annual report with the State, detailing information such as the manufacturer’s costs related to R&D, and costs paid for distributing the drug. Representatives from industry groups, PhRMA and BIO, testified before a committee, saying that the proposed law would harm patients and industry companies.

The clock is running down for 2014 data submission to Open Payments. With that in mind, CMS recently held a Q&A session to deal with any burning questions from Applicable Manufacturers and GPOs. During the call, CMS suggested that companies that have United States spelled out in their files deleted their records, change to “U.S.” and resubmit. So far the work around has proved largely successful. The agency also noted that it can trace deleted manufacturer records and said in order for companies to avoid audit issues and possible penalties, companies should separate rejected records from accepted records.

Sandoz was called for a costly foul when the company agreed to settle with OIG for $12.6 million over allegations it misrepresented drug pricing data. According to the OIG, between 2010 and 2012, Sandoz misrepresented the Average Sales Price (ASP) to CMS. As part of the settlement, Sandoz had to certify that it has established a government pricing compliance program.

The DOJ is adding quite a few new players to its FCPA enforcement team. The agency has confirmed it is adding 30 new agents specifically to deal with FCPA violations. More hands on the DOJ deck raise the stakes for companies in their compliance efforts. Legal experts say companies need to take a look at their internal and external anticorruption programs, and conduct reviews of internal controls, risk assessment, and third-party due diligence.

The SEC plans on beefing up its FCPA enforcement schedule. At the Corporate Counsel Institute conference, the SEC’s enforcement director, Andrew Ceresney, said that the agency’s regulatory focus would be on internal controls, and more FCPA enforcement actions. He pointed out that the SEC has already brought more FCPA cases in the five months of the 2015 fiscal year, than it did in all of 2014.

Public Citizen is asking the FDA to withdraw a proposal that would allow pharmaceutical companies to distribute peer-reviewed articles containing data stating a drug is not as risky as indicated on the label. The group sent a letter to Health and Human Services, saying the proposal would allow drug companies to “sell more drugs by making them appear safer than the FDA judged them to be.” Public Citizen has obtained and published all the comments the FDA has received on the proposal. Most of them are in opposition to the idea.

That about wraps it up for this edition of the Compliance Week in Review. Here’s hoping your favorite college squad is still in the hunt for a Final Four – we’ll be here wondering what exactly happened to our Villanova Wildcats (there’s always next year…again).

Have a great week everyone!

News Week in Review, February 18, 2015

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Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on Healthcare holds a lively panel session on the Sunshine Act.

Laissez les bons temps rouler, y’all! The end of the Carnival season is here and yesterday was the big send off…Fat Tuesday! Or as you may know it, Mardi Gras. Yes, a time of frolic, frivolity, and according to Turbo Tax, a number of incidents that can affect the filing of your taxes for the next year. Whether you partied until the wee hours in NOLA, or just enjoyed the simple fun of a pancake dinner at home, we hope it was a great celebration. Now it’s time for our regular look back at some of the “celebrated” compliance news of the week, with this edition of the Compliance News in Review.

We start today’s parade with settlement news for several industry companies. Medtronic agreed to pay $2.9 million to settle allegations it violated the False Claims Act. The government alleges the company caused claims to be submitted to Medicare and Medicaid for an investigational procedure. Next, AstraZeneca paid $7.9 million to settle charges it violated the False Claims Act. The company is alleged to have paid kickbacks to PBM Medco in exchange for Nexium’s “solely and exclusively” being maintained on Medco’s formulary. The government claims the kickbacks were provided as prices concessions on other AstraZeneca drugs. Finally, a physician has pled guilty to accepting kickbacks from two pharmaceutical companies in exchange for prescribing the drug, Clozapine. The physician received nearly $600,000 in kickbacks and benefits from IVAX and later, Teva. He also agreed to pay over $3 million to settle a parallel civil case.

The Centers for Medicare & Medicaid Services has been busy tossing beads and doubloons to the industry in the form of advice and consultation. Another Open Payments Q&A session was held just this past week, and in advance of the Q&A session, CMS released several new resources covering system registration and data submissions. The agency has also posted the audio from the January Q&A session.

Speaking of the Q&A session, the February session covered a couple of important topics for industry stakeholders. First, it was announced that a fix would occur over the Valentine’s Day/Presidents Day weekend that should resolve most of the problems that companies are having with submission of the 2013 data. On the downside, attendees were notified that the release of the Validated Physician List has been delayed. CMS is hoping to have the list ready by February 20. Those on the call were reminded that this list is only comprised of physicians for whom a 2013 record was submitted. CMS is scheduling a full day to take stakeholder questions. As soon as a date is nailed down, it will be announced on the Open Payments website and via a listserv email.

It wasn’t exactly cause for great celebration, but a recent briefing held by the National Coalition on Healthcare led to the call for expanded requirements under the Sunshine Act. The panel was comprised of individuals from the government, physician groups and the Pew Charitable Trust. A representative from Senator Grassley’s office explained that ultimate goal of the Sunshine Act was to spur an open discussion between patients and their doctors. The founder of PharmedOut, an organization that advocates against pharmaceutical marketing influence in medicine, took the harshest stance, saying the law wasn’t strict enough. She accused companies of seeking out the family and friends of physicians as an avenue for delivering marketing messages, and expressed grave concern about the industry engaging in disease state awareness. Drug samples were a hot topic. A representative from the AMA says there is a gap in transparency where the provision of samples is concerned and he believes providing samples is “misdirected and unsafe.” The founder of PharmedOut agreed, stating that patients should refuse samples and ask for older drugs that have stood the test of time.

That’s about it for the edition of our weekly look back on all the news fit to blog. As we get closer to spring (albeit, slowly for those of us in the Northeast), and the annual POAs are in the rear view mirror, this is as good as time as any to clean up your commercial compliance training. With transparency extending beyond the U.S., shouldn’t your training do the same? The newest addition to our PharmaCertify™ suite of off-the-shelf eLearning modules, Global Transparency: Reporting HCP and HCO Transfers of Value covers the key provisions of the EFPIA Disclosure Code, French Sunshine Act (Loi Bertrand) and the Medicines Australia Code of Conduct. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more and see a content outline.

Have a great week everyone!

2014 Year in Review

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2015 is upon us! It seems like only yesterday we were posting our 2014 Compliance Year in Review. Time sure does fly! We here at the Compliance News in Review wish you and yours the best for a happy and healthy 2015. But don’t toss out that warm glass of sparkling cider or noisemaker yet. It’s time to take a look back at a year’s worth of news, with the Compliance News Year in Review – 2014 Edition.

Our countdown begins with what had to be the big story of 2014 – the never ending saga of Open Payments and the Sunshine Act. The year began with a two-phase registration and data submission process for Applicable Manufacturers and GPOs. Phase 1 opened in February and Phase 2 was supposed to start in May. As it turned out, Phase 2 was delayed until June and was deployed in two phases itself, and not without some technical difficulty. So much so that PhRMA petitioned CMS to extend Phase 2 by as much as 30 days.

The registration of physicians and the opening of the review and dispute period represented the next big milestones. That’s when the fireworks really started. Physicians had problems registering, and when they could finally view the data, there were significant problems – confusing “error” messages, missing payments, payments attributed incorrectly. CMS took the system down to correct the problems, and extended the review and dispute period to accommodate for the time the system was down. When Open Payments opened back up for physicians, almost one-third of manufacturer records were “missing.” Eventually, CMS said the records were withheld due to data matching problems. A number of issues were identified that caused the data to disappear. The primary offenders appeared to be state license numbers and NPI numbers submitted by manufacturers and GPOs that did not exactly match what CMS had in its database for those identifiers. Despite all the delays and problems, CMS said the September 30th date for making payment records public would stand, minus the withheld records. Those records would be published by June 30 of the next year.

September 30th came, data was published, and all was right with the world, right? Onward to 2015! Not so fast there dear readers. As we all spent time regretting those unfortunate photos taken at the office Christmas party, CMS elves were busy at work. The agency released 68,000 records that were previously withheld, notified users that Open Payments would be unavailable for most of January to allow time for system maintenance, and announced it will be hosting an Open Payments Q&A in early 2015.

Yes, it was a full year of Open Payments fun, but the news surrounding the data was not all CMS had up its transparency sleeve. The agency notified stakeholders that changes were on the way for Sunshine’s Final Rule. The one change that sparked the most debate was the removal of the exemption for payments to physicians speaking at accredited CME events. Medical societies, physician groups and CME providers were staunchly opposed to the change, but it was still made official in October. The change will take effect in 2016 but it may not be the end of the road for the exemption. A bipartisan bill was proposed to exempt indirect CME payments, as well as the value of medical textbooks and reprints.

Other news of note on the transparency front for 2014 included the passage of a law in Connecticut that requires the reporting of industry payments to nurse practitioners; Minnesota making good on the Board of Pharmacy’s notification that payments to nurse practitioners and others would be required in 2015 reports; and the changes in transparency requirements to the Medicines Australia Code of Conduct.

The cork popped on GSK’s bribery woes in 2014. The company was one of several pharmaceutical companies under investigation by the Chinese government for allegations of bribery. The company announced it was investigating potential bribery in Iraq, Jordan, Lebanon, Poland, and Syria. GSK enhanced its compliance efforts in China and fired several employees over failure to adhere to expenses rules. In the fall, it was able to close the book on the Chinese investigation with a fine of close to $500 million dollars. The head of China operations and four other executives were sentenced in the matter, but all had their jail sentences suspended and avoided actual jail time. The head of China operations, a British national, was deported. The company could still face legal action from the U.S. Department of Justice and the U.K.’s Serious Fraud Office for violating bribery laws.

The FDA resolved it would make the July 2014 deadline for social media guidance, and it actually did! Three draft guidance documents related to social media were published. One document is related to the submission of advertising content, and the other two dealt with actual postings on social media platforms. The guidance on correcting misinformation on social media platforms applies to correcting independent user-generated content, and not content generated by a company, its employees or agents.

The more anticipated document, and the one that drew the most criticism, deals with the posting of information on character-limited platforms, such as Twitter. Some companies feel the FDA has basically restricted them from using character-limited platforms to promote their products due to strict requirements around presenting risk and benefit. The Washington Legal Foundation and the Medical Information Working Group said the guidance infringes upon manufacturers First Amendment rights.

And there you have it, our choices for top stories of 2014. What will be the “big news” of 2015? If we were betting people, we’d put money on Open Payments and Sunshine being the stories that generate the most headlines. With a full year’s worth of spend data hitting the system for the first time, expect more hiccups. Also, a full year’s worth of data is likely to reveal even more issues and have the pundits buzzing. Transparency overseas will likely make news in 2015, as EFPIA member associations and Medicines Australia members begin collecting data for disclosure in 2016.

There was a noticeable lack of big dollar enforcement cases in healthcare fraud and FCPA cases last year. While the DOJ could boast upwards to $2 billion in healthcare fraud recoveries for the 2014 fiscal year, there were no billion or multibillion dollar settlements with life sciences companies. The crystal ball is a little cloudy on that front. Was 2014 the calm before the next storm, or has the season of the multimillion to billion dollar settlements with pharma and med device companies come to an end?

FCPA enforcement actions were in a bit of a lull through at least the first half of 2014 compared to years past. The DOJ ended the year on a big note though, with its Alstom settlement. As far as we’re concerned, it’s been a little too quiet lately where FCPA enforcement is concerned, so we wouldn’t be surprised to see more activity in 2015. Don’t be surprised if we see actions against the handful of pharma companies that were accused of passing bribes in China in 2013.

Whatever 2015 brings, we’ll be writing about it through our weekly Compliance News in Review. Have a great year everyone and as always, thanks for reading!

Week in Review, December 16, 2014

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Otismed pleads guilty to selling knee replacement cutting guides that had been rejected by the FDA, Senators Hatch and Bennett introduce bill to exempt low risk software from the definition of a medical device, and the oversight group for the APBI Code of Conduct chastises Galderma over the requirements for attending a presentation.

They litter the landscape of the Christmas season, and have become so iconic that an entire day is dedicated to celebrating the infamous ugly Christmas sweater. It’s as much a fixture of the season as Santa hats and reindeer antler headbands. In fact, a number of on-line retail outlets have jumped on the bandwagon for this haute mess couture. Before we get dive into a debate over the categorization of light-up sweaters as “ugly” or just a “whole separate item,” we’ll dive into something a little less controversial, this week’s Compliance News in Review.

This isn’t a warm and cozy situation for Otismed and its former CEO. The company pleaded guilty to criminal and civil charges that it sold knee replacement surgery cutting guides despite it being rejected by the FDA. According to prosecutors, the former executive directed that over 200 of units be shipped despite the product not receiving FDA clearance and the company’s board voting to cease shipments of the product. Otismed was purchased by Stryker, which was unaware of the incident at the time of purchase. The company will pay $80 million to resolve the charges and the former CEO will be sentenced in March of 2015.

There are no ugly feelings from med tech innovators about a bill recently introduced in the U.S. Senate. Senators Orin Hatch and Michael Bennett have introduced a bill that will exempt low-risk medical software and apps from the definition of a medical device under the FDCA. The senators say the bill will provide clarity over which devices should be regulated. The bill, called the MEDTECH Act, removes five categories of innovation from the definition of a covered device.

Could the Prescriptions Medicines Code of Practice Authority (PMCPA) be unraveling its ties with Galderma? PMCPA, the oversight group for the Association of the British Pharmaceutical Industry’s Code of Practice, and Galderma are at an impasse over a public reprimand issued against the company by the organization. The reprimand stems from a complaint lodged by a nurse attending an educational meeting sponsored by Galderma. The complaint alleges that attendees had to prove they had purchased the company’s filler in order to attend the presentation. In addition, the PMCPA says attendees received financial incentive to attend in the form of free product. Galderma says it was not uncommon to require attendees to purchase product in order to attend, and the filler is a medical devices so any related activities do not fall under the Code. Galderma appealed the decision, and the PMCPA has removed the company from its list of companies agreeing to abide by the Code.

With that, we put a wrap on this week’s edition of the News in Review. Good luck with those ugly sweater contests this weekend everyone, and remember, light-up reindeer noses always seem to catch the judge’s eyes.

Have a great week!

Week in Review, November 26, 2014

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Time to head over the river and through the woods to grandmother’s, or somebody’s house, for turkey, gravy, stuffing and pumpkin pie! Thanksgiving is almost here! The Week in Review staff is excitedly looking forward to a day of family, football (Go Eagles!) and tryptophan. Before we start the food prep and festivities though, we need to take care of a little business first; this week’s Compliance News in Review.

Doctors in Michigan aren’t just talking turkey when it comes to the context that surrounds public disclosure of physician payments under Sunshine. A Michigan news outlet gave the physicians that received the most in payments a chance to provide that context. The five doctors received payments in the hundreds of thousands of dollars. For most, the payments represented royalties for devices they had invented. One physician received in excess of $500K for clinical research. The money did not go to the doctor, but to the clinic for which he works, and he is strictly a research physician. Another received almost $350K in payments for consulting and speaking. This physician is a plastic surgeon who runs a training center to teach other physicians. He says consulting pays 1/10th of what he would receive if he were working in his practice, and therefore is not financially beneficial. All of the doctors profiled said they believed physicians should be upfront with patients about their financial relationships with life sciences companies.

A jury in West Virginia found Takeda destroyed documents related to the drug Actos and ordered the company to pay $155,000. The case was brought by an individual who claimed the destruction of the files prevented him from proving his case that the company failed to provide adequate warnings about the cancer risks associated with the drug. A Takeda spokesperson said the company is considering an appeal.

Recoveries from False Claims Act cases are stuffing the federal treasury. The Department of Justice announced that nearly $6 billion was recovered through the False Claims Act in fiscal year 2014. Housing and mortgage fraud represented the largest amount of recoveries at $3.1 billion. Healthcare fraud recoveries were not too far behind at $2.3 billion. Whistleblower cases resulted in nearly $3 billion in recoveries and the government paid out $435 million in whistleblower awards.

The OIG has released a report of the top challenges and issues facing HHS during fiscal year 2014. The report lists several issues related to Medicare, Medicaid and the federal healthcare exchanges. Number ten on the list, ensuring the safety of food, drugs, and medical devices, should be of particular note for the industry. This challenge primarily addresses problems associated with drug compounding and importation of drugs from foreign countries, but the OIG also cites drug marketing; specifically off-label marketing. According to the report, illegal off-label marketing undermines the system intended to ensure that drugs are safe and effective, and may lead to fraudulent claims for reimbursement being submitted to Medicare and Medicaid.

With that final serving of off-label news, we’ve come to the end of this holiday edition of the Compliance News in Review. Have a wonderful Thanksgiving everyone, and remember, it’s all about that baste.