News Week in Review, February 18, 2015

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!

News Week in Review, January 26, 2015

Senator Warren looks to use pharmaceutical company penalties to support research at the FDA and NIH, a new report reveals that a significant amount of businesses in China pay bribes, a physician lobbies for a Sunshine Act in Scotland, and a bill is introduced in the House to exclude CME and medical texts from Sunshine reporting.

Comedy, drama and just a dash of controversy thrown in for good measure. No, we’re not referring to this year’s Oscar nominations – although one does have to wonder how The Lego Movie was snubbed for Best Animated Picture – we’re talking about the NFL’s annual supreme slugfest, the Super Bowl. This Sunday, millions will park themselves in front of their television sets to see the Patriots and Seahawks fight it out for the Lombardi Trophy (and of course, the cursory trip to Walt Disney World). If you’re ready for a brief respite from the politics of “Deflate-gate,” we offer all the compliance news fit to blog, with this week’s News in Review.

Starting on offense in our first story is Senator Elizabeth Warren. During a conference hosted by a health advocacy group, the Senator said she intends to introduce legislation that will create a fund to support research at the FDA and NIH. The fund, which Warren referred to as a “swear jar” for the industry, would be financed through fines imposed on large pharmaceutical companies that break the law. Fines will only be imposed on companies with at least one blockbuster drug, and would equal 1% of a company’s total profits for each blockbuster drug it sells.

PhRMA quickly lined up on the other side of the ball to oppose the issue. The organization pointed out that the industry spends billions of dollars on research each year and is responsible for 20% of all funding of domestic research. The statement went on to say the work of the NIH is important, but to “siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society.” Those consequences would ultimately include fewer medicines and loss of jobs.

If you think Deflate-gate is controversial, it doesn’t compare to a recent report that found 35% of businesses in China pay bribes in order to do business in the country. One CEO participating in the research called bribery the “unspoken rule.” The problem is more common in foreign companies than those based on the mainland, and the real estate and construction sectors have the highest instances of bribery. The vast majority of research participants describe bribery in China as a “plague,” and just over 60% of the participants would like to see action taken to stave off the problem. Unfortunately, a third of participants are not optimistic about that happening.

It’s third down and goal for a transparency initiative in Scotland. A physician will have his petition for a Sunshine Act in Scotland heard by the Scottish Parliament for the third time. The physician is petitioning the government to create a law that establishes a searchable database of payments from pharmaceutical companies to National Health Service healthcare workers.

We’re back in the transparency replay booth here in the U.S. as well. A bipartisan bill was introduced in the House of Representatives to exclude the value of CME and medical texts from reporting, under the Sunshine Act. This is the second go around for the bill in the House.

Well, that’s it for this Super edition of the Compliance News in Review. Whether you’re rooting for the Seahawks or Patriots, or just a great halftime show by Katy Perry, enjoy the game and we’ll see you right back here next week. Have a great week everyone!

2014 Year in Review

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 Review2014 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

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, December 10, 2014

The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!

Week in Review, November 26, 2014

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.

Week in Review, November 5, 2014

The OECD questions Japan’s bribery law, OIG releases its 2015 Work Plan, CMS hopes to clarify the issues with data mingling, and Biomet settles False Claims Act charges against one of its subsidiaries.

Well, it certainly was a spooktacular weekend full of ghosts, goblins, and sugary goodies. November is upon us and Thanksgiving is just around the corner. But before we start the annual debates over canned or real cranberry sauce, or apple pie vs. coconut custard (a particular favorite at the Week in Review home offices), we have one more treat; this week’s News in Review.

The Organization for Economic Cooperation and Development (OECD) is taking issue with Japan’s ghost-like anti-bribery enforcement efforts. Japan does have a law prohibiting bribery of foreign officials, but it has done little in the way of enforcing that law. Under pressure from the OECD, the Japanese government developed a plan to increase enforcement, but the organization claims the law doesn’t address key issues, such as facilitation payment. The government plans to make more changes, but businesses are not waiting. According to Transparency International, a number of businesses are seeking guidance on how to develop effective anticorruption programs.

If you’re looking for a little something to help you take advantage of that extra hour of sleep we picked up over the weekend, the OIG has released its 2015 Work Plan. Sweet dreams.

CMS provided a few treats for applicable manufacturers and GPOs caught up in the data mingling issue that occurred during the inaugural submission of physician payments records. The agency has returned the report records to those affected and has given manufacturers and GPOs until March 31, 2015 to re-submit corrected records. A webinar for organizations with a returned record report is scheduled for November 13th and CMS is also providing a Validated Physician List in the Open Payments portal.

It wouldn’t be Halloween without a few surprises and CMS was happy to oblige. The agency announced several changes to the Sunshine Act Final Rule. The changes include the removal of the CME exemption; the deletion of the “covered device” definition; a requirement to report the marketed name and therapeutic area of a covered drug, device or biologic; and a requirement that stocks, stock options and any other ownership interest be reported as separate categories. The changes are effective immediately, but due to comments from industry CMS and the time needed to make changes to manufacturer systems, the changes will be implemented in the 2016 collection year.

On the settlement front, Biomet agreed to pay $6 million to settle charges it violated the False Claims Act. According to prosecutors, EBI, Inc., a Biomet subsidiary, provided kickbacks to encourage physician office staffers to use its bone growth stimulating product. The lawsuit was filed under the False Claims Act by a former product manager.

We close this week’s Review with a reminder that as you look to expand, supplement, or revamp your compliance curriculum, PharmaCertify™, from NXLevel Solutions, offers the off-the-shelf and custom training solutions you need to continually deliver critical compliance content where your staff needs it most – in the field and at their fingertips.

Have a great weekend everyone.

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