UK Bribery Act

Week in Review, August 27, 2014

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Another industry organization calls for a change to the Sunshine Act, manufacturers claim data entered into Open Payments is now lost, the Supreme Court is petitioned to review the definition of instrumentality as it pertains to the FCPA, and questions are raised about potential reporting loopholes in the Medicine’s Australia Code of Conduct.

Bananas, fish fingers and custard for all! Doctor Who, season eight, is here! Finally, 12 makes his debut, and we can only hope that he still thinks bow ties and fezzes are cool. And can we just take a moment to thank BBC America for scheduling Doctor Who to run here in the U.S. when it runs on BBC 1? Now we don’t have to spend months trying to avoid news about the show, like we do for Downton Abbey. So let’s jump in the TARDIS and take a journey back in time with this week’s News in Review.

Exterminate! Exterminate! That’s the sentiment of the Council of Medical Specialty Societies (CMSS) regarding CMS’ proposed change to the rule in the Sunshine Act about payments for CME. The Council said the current exemption for payments associated with accredited CME needs to remain in place for several reasons. First, a distinction should be maintained between accredited and certified CME and other educational programs in order to preserve the independence of CME programs. Second, faculty payments should not be subject to reporting because the faculty member’s relationship is with the CME provider, not the manufacturer. Finally, attendees of accredited CME should not be subject to the reporting of payments, because like faculty, attendees have no relationship with the manufacturers providing grants for a program.

Speaking of Sunshine, after Open Payments came back online, drug and device manufacturers reported that payment data once in the system is now gone. CMS says the missing data is due to matching issues. Some of the issues are the result of a data marrying problem that took the system down recently. In other cases, information such as license numbers and names do not exactly match the information in CMS’s database. Policy and Medicine was informed by manufacturers and physicians alike that information that was accurate in Open Payments is now missing. One manufacturer claims all of its clinical research data is now gone. According to the article, the problem could be with the NPPES (National Plan and Provider Enumeration System) database. Portions of New Jersey doctors’ state license numbers were cut off in the database. Also, an analysis last year by the OIG found that almost half of the NPPES records that were inspected contained at least one inaccurate piece of information.

What is instrumentality under the FCPA? We could ask the Inner Council on Gallifrey, but since that is fictional (what!?), the U.S. Supreme Court will have to do. The high court has been petitioned by two individuals convicted of bribery under the FCPA to review a federal appeals court’s definition of an “instrumentality.” The two were convicted of paying kickbacks to employees of a government-owned telecommunications company. The government argued the telecom company was an instrumentality of the government, and the appeals court agreed.

 

Some advocacy groups are already looking for a regeneration of Medicines Australia’s transparency requirements in the latest edition of that group’s Code of Conduct. The Code is pending authorization by the Australian Competition and Consumer Commission (ACCC). The organizations have petitioned the ACCC to not authorize Medicines Australia’s Code of Conduct based on potential loopholes that will allow physicians to opt out of having their payment information publicly disclosed.

 

Well, that bring us to the end of this week’s episode. Based on the plethora of recent news stories related to Open Payments, the demand for transparency when dealing with HCPs isn’t going away anytime soon. The Sunshine Act: The Federal Physician Spend Disclosure Law, from our PharmaCertify™ suite of customizable online compliance modules, offers the content your team needs to stay abreast of the ramifications and reporting requirements of the law. We even offer a complementary Sunshine Act mobile app to help ensure your reps have the information where they need it most – in the field and at their fingertips.

 

Have a great week everyone!

 

Have a great week everyone!

 

Week in Review, August 19, 2014

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The widespread use of DPAs and NPAs in bribery cases raises legal concerns, CMS shuts down Open Payments to correct data problems and subsequently announces it will actually withhold one third of the data until June 2015.

Can you feel it? The air is heavy with despair. It may be faint, but the smell of newly sharpened pencils and mimeograph ink (remember that stuff?) is in the air. It’s back to school time! If you need help figuring out what to buy for Junior’s backpack this year, the trusty editors at Good Housekeeping have created a series of school shopping lists divided by grade level. You may be surprised to see tissues and hand sanitizers on there, along with the staples like pencils and glue sticks. Don’t forget the hand sanitizer and tissues!

To go this year started, we begin with a little reading assignment of our own. Put your thinking caps on class, it’s time for this week’s News Week in Review (and most of this will be on the test).

Corporate Bribery + Prosecution Agreement = End to Case. According to a recent Forbes article, the widespread use of Deferred Prosecution Agreements and Non-Prosecution Agreements in bribery cases is troubling from a legal standpoint. Using DPAs and NPAs leads to the charges being untested in court and self-reporting can do more harm than good. The authors argue that companies or individuals are better off fighting untrue or exaggerated claims, rather than opting for the settlement route.

No school year would be complete without a little drama, and thanks to Open Payments we have quite the soap opera to tell. Days after physicians and teaching hospitals were able to access Open Payments to review the data reported about them, at least one physician found that payments from another physician with the same name were showing up on his report. CMS subsequently shutdown the Open Payments portal for physicians and teaching hospitals. The shutdown dragged on for eleven days before the portal was reopened, and so far, so good. CMS extended the review and dispute period for physicians and teaching hospitals to September 8. The public website will still be available on September 30th.

All’s Well that Ends Well, right? No so quicketh, faire reader. The malady was resolved, but hark, hear now cometh a report that all information will be revealed not! (okay, we apologize for the rough attempt at Shakespearean English) CMS has announced that due to data inconsistencies, it will withhold one-third of Sunshine data from the public website. The records are being returned to the submitters to address issues of data intermingling. The data will be released in the June 2015 publication. In addition to clearing up the errant records, CMS replaced a confusing error that appeared when a search yielded no payments for a physician or teaching hospital.

As the bell rings on this edition of the Compliance News Week in Review, we dismiss you with the reminder that the PharmaCertify™ suite of eLearning modules and mobile apps offer the up-to-date information your staff when and where they need it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, August 5, 2014

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Industry groups ask CMS to help clarify context of physician payment data, a study finds most physicians have yet to visit the Open Payments website, another medical device company settles a False Claims case and Senator Grassley weighs in on the concept of a gold standard certification for compliance programs.

The calendar tells us the dog days of summer are upon us. Luckily, some of us have had a bit of a “cold spell” recently, so those dog days haven’t had quite the bite they normally do. As you seek ways to deal with the combined heat of the sun and of the Dog Star (as ancient stargazers may have believed), we offer a cool refreshing break of a different sort, with this week’s Compliance News in Review.

Industry and medical groups are putting the heat on CMS. Over 20 medical associations, PhRMA, and BIO sent a letter to CMS asking how the agency plans to help the public understand the nature and purpose of the physician data that will soon be available through Open Payments. The groups cited the recent release of Medicare Part B payments as an example of why they are concerned about proper context. They claim that context was missing when CMS released the Part B data, causing confusion as to which doctors were abusing the system and which were receiving large payments for legitimate reasons. The letter also asked CMS to reach out to the physicians and make them aware that the data will be published soon. Responding to inquiries from the Wall Street Journal, a CMS spokesperson said the agency plans to publish that nature of payments to physicians and teaching hospitals and provide context for the public.

A majority of physicians are slow to step into the Sunshine according to a new survey. The study found only 7% of physicians have visited the Open Payments website and 85% want to review payment data before it is sent to CMS. 80% want to be informed of the value of items before they accept them. The survey also indicates the majority of physicians are concerned with public perception once the data is published. Physicians seem to be more willing to accept certain payments over others. For example, only 16% of physicians said they would no longer accept meals but, 40% say they will no longer accept gifts. The study also addressed companies’ best practices in aggregate spend systems and global transparency.

On the settlement front, medical device company, Vascular Solutions, agreed to pay $520,000 to settle allegations it violated the False Claims Act by promoting its product for an unapproved use. The suit was brought by a former sales rep, and alleged the company promoted a kit for the treatment of veins deep in the leg, rather than varicose veins near the surface of the skin, the use for which it has been approved.

No gold stars for compliance programs says Senator Chuck Grassley. At a House subcommittee meeting on the False Claims Act (FCA), several witnesses referenced a Chamber of Commerce report that proposed a program through which companies could be certified as having a “gold standard” compliance program. Companies achieving the certification would be treated differently under the FCA and requirements for whistleblowers would change. In comments following the meeting, Senator Grassley said he was not in favor of a program that provided such a “get out of jail free card.” Grassley is skeptical about companies self-reporting and he claims having a certified compliance program will not change whether they do or do not self-report.

With that, we close our dog days of summer issue of the Week in Review. Have a great week everyone and we’ll see you by the pool!

Week in Review, July 9, 2014

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CMS makes changes to reporting deadlines and requirements, Canada continues to collect date about the effects of off-label use of drugs, and Medicines Australia updates its Code of Conduct.

You scream, I scream, we all scream for ice cream! And we’ll be doing a lot of screaming because July is National Ice Cream Month. (July – 31 days. Baskin-Robbins – 31 flavors. Coincidence?) Whether on a cone, in a cup or topped with sauces, fruit or confections, July is a great month to enjoy this cold treat. And gone are the days when Tutti Frutti was the outrageous flavor. Now, along with the likes of Cookies & Cream and Rum Raisin, you can have your pick of Chocolate-Chili, Roasted Garlic, or Mushy Green Peas. As you ponder your favorite flavor (bizarre or otherwise) for beating the July heat, we offer our own scoop with this week’s News in Review.

The deadline for submitting Phase 2 data melted away, sort of, last week. CMS sent out an email essentially extending the deadline for submitting Open Payments Phase 2 documents to July 7. In the e-mail, CMS said it wanted to assure accuracy and completeness of the reports and attestations and that penalties would not be enforced for non-compliance until after July 7.

Also melting away could be the CME exclusion in final rule for the Sunshine Act. CMS is planning to propose a change to the exemption for reporting CME payments. The current rule allows an exemption for three reasons: the program is accredited by certain organizations, the physician isn’t paid directly by the manufacturer, or the manufacturer doesn’t influence the selection of speakers. CMS ultimately decided to remove the exclusion due to the redundancies involving indirect payments that occur when the manufacturer is unaware of the recipient. The agency also does not want to appear that it is indicating support of certain accrediting bodies by continuing to specifically name them in the exemption. The proposed changes will appear in the July 11 Federal Register.

And if the CME change isn’t enough, CMS has a few other toppings to add to the final rule sundae. The agency is also proposing that “stock, stock options, and other ownership interests” not be one category, but three. Other changes include the requirement that all manufacturers, including device manufacturers, use the product’s marketed name on reports and the removal of the “definition of a covered device” from the rule.

Canada’s Health Minister, Rona Ambrose, is serving up a scoop or two of new information about serious side effects resulting from off-label drug use. Health Canada has been collecting the information for several years, but technical issues prevented it from making the database of information publicly available. The group is planning a systems upgrade that will allow the regulator to share the database. No timeline for when the public can expect to access the information has been released.

Medicines Australia is looking for approval of its latest flavor. The organization has submitted the 18th edition of its Code of Conduct to the Australian Competition and Consumer Commission for authorization. The new Code includes requirements for the reporting of transfers of value from industry to healthcare professionals. If authorized, the Code will become effective January 2015, with the new transparency requirements going into effect October of 2015. However, not everyone is happy with the result. A provision requiring manufacturers to obtain permission from physicians to allow their name to be published with the payment data, has members of the Greens political party very concerned. A spokesman said the party was considering reintroducing legislation to make the reporting of transfers of value to physicians a legal requirement.

Sunshine and transparency will no doubt continue to be a popular flavor, both here and abroad, for the distant future. That’s why we are adding a global transparency focused module to our growing list of PharmaCertify™ off-the-shelf learning solutions. To learn more about the module or see a content outline, contact Sean Murphy at smurphy@nxlevelsolutions.com.

Have a great rest of the week!

Week in Review, July 1, 2014

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CMS adds two dozen FAQs to the Open Payments website, PhRMA requests an extension to the data submission deadline, and more companies decide to share clinical trial data with researchers through the ClinicalStudyDataRequest.com portal.

Strike up the fife and drums, it’s time for the annual Star Spangled salute to the U.S.A. Independence Day is almost here! In a letter to his wife Abigail, John Adams suggested this day be celebrated with “pomp and parade, with shows, games, sports, guns, bells, bonfires and illuminations from one end of this continent to the other, from this time forward forever more.” The great statesman’s words could not have been more prophetic. As you ponder how to best celebrate our nation’s independence this year, we offer a tradition of our own, this week’s compliance News in Review.

There was an explosion of information on the Open Payments website. CMS recently added over two dozen FAQs to the site. Most of the FAQs deal with Phase 2 data submission and attestation. The questions center on how long it will take CMS to validate submitted data; whether a resubmission of data requires a new attestation; and what the process is for resubmitting corrected data. Other FAQs about data collection, registration, and participation in Open Payments were also added.

PhRMA has sent a declaration of sorts to CMS, requesting an extension to the deadline for Open Payments Phase 2 data submission attestation. In its letter, PhRMA cited the technical issues its members were experiencing with the Open Payments website. The organization claims the problems seem to be occurring most with foreign companies and foreign subsidiaries of U.S. based companies and the CMS helpdesk is not operated during hours that would accommodate European or Asian time zones. Since several manufacturers have not even been able to complete the registration process, PhRMA is asking that the deadline be extended by 30 days. Two other concerns are also addressed in the letter. First, manufacturers do not have the ability to indicate when a manufacturer received a refund on a transfer of value. This is a common occurrence with research grants. Also, manufacturers are unable to use characters such as parentheses and mathematical symbols in the text box for assumptions.

Was last year’s Supreme Court decision concerning pay-for-delay deals the shot heard ‘round the pharma world? The Federal Trade Commission (FTC) has opened several new investigations into pay-for-delay deals. In an interview, Markus Meier the head of the FTC’s health-care division, said “Our goal is to bring to an end to this practice by whatever means are available to us.” He did not provide any details regarding the new investigations. The agency is also looking for possible antitrust issues in patent settlements from the last 10 years.

Lilly, Bayer and Boehringer Ingelheim are joining the clinical trial data sharing celebration. The companies joined the list of those sharing of patient level clinical trial data through the ClinicalStudyDataRequest.com website. The site provides a secure Internet portal through which researchers can request patient-level anonymized data.

We wrap up this week’s firecracker report with a story from our friends overseas. The European Federation of Pharmaceutical Industries and Associations (EFPIA) recently launched a website to highlight the disclosure rules associated with the EFPIA Disclosure Code on Transfers of Value to Healthcare Profession and Healthcare Organizations. The agency also released a template for upcoming disclosure reports.

With that, we close out this red, white and blue version of the Week in Review. Have a great week everyone, and an amazing Independence Day!

Week in Review, May 27, 2014

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CMS prepares for Phase 2 of Open Payments registration, data submission, and attestation; Washington D.C.’s Department of Health announces it will not require the reporting of gift expenses; Roche gets a visit from the State Authority for Industry and Commerce in China; and the FDA evaluates its off-label promotion policies in light of First Amendment cases.

Summer has arrived! Well, not really, but Memorial Day certainly marks the unofficial start of the season. And nothing says summer more than a trip to the beach. Or as our New Jersey staffers like to say, “down the shore.” If you’re struggling to shake the sand off of a memorable weekend at the beach, and refocus on all things compliance, we’ve got just the remedy…this Week’s News in Review.

Break out those beach towels and SPF 70, it’s time to bask in the Sunshine. Phase 2 of Open Payments registration, data submission and attestation will begin on June 1. This phase will occur in two parts, with the first beginning June 1. Applicable manufacturers and GPOs will be able to register in Open Payments; confirm the reporting entity profile; assign roles within the system; and upload test files. Then, beginning June 9, manufacturers will be able to submit final reports and attest to the accuracy of those reports. Companies have until the end of June to complete both parts of Phase 2.

The Sunshine is a little less intense in Washington D.C. The District’s Department of Health will not require pharmaceutical companies to submit gift expenses for physicians and teaching hospitals. For the 2013 reporting year, manufacturers and labelers do need to report physician and teaching hospital gifts provided prior to July 31, 2013. Also, expenses for all other recipients must be reported. Reporting requirements for advertising and aggregate expenses remains the same.

Roche may have found themselves caught up in the wave of bribery investigations in China. The company revealed that China’s State Authority for Industry and Commerce (SAIC) paid a visit to one of its facilities in China. The SAIC is generally the lead agency in bribery cases. Roche said the reasons for the visit were not immediately clear.

Could the FDA be rearranging the beach chairs when it comes to off-label promotion? Recent court decisions have raised issues around the First Amendment and drug promotion, and FDA chief counsel says the agency is taking the “First Amendment concerns very seriously.” The Center for Drug Evaluation and Research chief, Janet Woodcock said, “We are currently carefully evaluating our policies in light of court decisions on First Amendment issues.” While the agency may be revaluating its stance, the DOJ still intends to aggressively pursue off-label cases.

Speaking of the FDA, the agency is planning a study to determine if bargain-hunting consumers weigh price more heavily than other attributes of a drug. The study will show three versions of an ad for a diabetes drug to patients and HCPs. One ad will feature a price comparison between the advertised drug and a competitor, another will feature pricing information only for the advertised drug, and the third version will state the drug’s safety and efficacy profile, and one that will inform the viewers that actual prices may vary. The FDA currently allows manufacturers to include pricing in advertising but very few do.

June 1 not only marks the beginning of Open Payments Phase 2 for manufacturers, it’s also the start date for physicians to register with CMS to access the reported data. This is a critical time for the industry, and keeping your team up to speed on requirements of the Sunshine Act is more important than ever. The PharmaCertify™ module, The Sunshine Act: The Federal Physician Payments Disclosure Law, includes a comprehensive list of the disclosure requirements included in the law and the physician spend information that will be shared with the public.

Have a great week everyone.

Week in Review, April 29, 2014

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Pakistan joins the transparency parade, Arkansas’ Supreme Court won’t reverse the Risperdal decision, one Google executive wonders why pharmaceutical companies aren’t using YouTube more, and the DOJ offers a reminder about the need for a proactive approach to compliance.

California Chrome. Vicar’s in Trouble. Wicked Strong. Titles to obscure B movies? Nope, they’re just some of the participants in the “greatest two minutes in sports.” The countdown is on to the Kentucky Derby! We have less than a week to polish up those mint julep cups and shop for that perfectly obnoxious large hat. In the meantime, sound the call to the post, it’s time for the News Week in Review.

First out of the gate is the news that Pakistan is considering physician-industry interaction transparency requirements. The Drug Regulatory Authority of Pakistan is driving the increased transparency initiative and Pharma Bureau, a trade group of multinational industry companies operating in Pakistan, welcomes the move. The Bureau sees consistent guidelines and enforcement as a step toward better patient care and an improvement in the industry’s image.

According to a new study, doctors who don’t accept drug samples are a long shot to prescribe branded drugs. The study, published in JAMA Dermatology, compared offices in an academic medical center, where samples are not permitted, to private practice offices that do accept samples. Only 17% of the prescriptions written for adult acne drugs in the academic centers were for branded drugs, compared to 79% of the scripts being written for branded drugs in the private offices.

No Big Bazinga from the Arkansas Supreme Court regarding its reversal of the Risperdal verdict. In a 4-3 decision, the court said it would not reconsider its March decision to overturn the verdict. The verdict was overturned when the court said the state’s Medical Fraud False Claims Act did not apply to the Risperdal manufacturer because the law was codified in way that conflicted with the intent of the law. Arkansas Attorney General Dustin McDaniel asked for the ruling to be reconsidered because the issue of how the law was codified was not raised but the state or the drug manufacturer.

The folks at Google think pharmaceutical companies could benefit from a little more Social Inclusion. The head of Google’s healthcare-focused digital marketing team, David Blair, says the industry could utilize YouTube more effectively. Online viewership has now eclipsed television, and according to Blair, one-third of You Tube users share what they watch. YouTube is also the second largest search engine behind Google and Blair believes pharmaceutical companies are missing an opportunity to make an emotional connection through a disease awareness video or wellness campaign.

According to experts speaking at the Dow Jones Global Compliance Symposium, companies should set an aggressive pace when scrutinizing their own compliance programs. A deputy attorney general from the DOJ told attendees at the Symposium that companies are too quick to claim the problem only involved a few employees and that’s one of the first signs of a weak compliance department. Attendees also learned that the U.K., Canada and Germany have all set up units similar to the DOJ’s FCPA unit.

That’s going to bring us to the finish line for this week’s News in Review. We’ll see you right back here next week with another summary of the news from the world of life sciences compliance. As always, thank you for reading and have a great week!

Week in Review, April 21, 2014

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The European Federation of Pharmaceutical Industries and Associations increases its education efforts, GSK conducts internal bribery investigations, FCPA experts warn of increasing scrutiny and some restaurants look for creative solutions to changing pharmaceutical company requirements.

May is almost upon us, and you know what that means…so is the summer movie season! It’s a time marked by seemingly endless blockbusters and family movies, released on a weekly basis. Captain America: The Winter Soldier “sort of” represented the unofficial start of the season, and in a matter of weeks, the parade of superhero, wacky comedies, sci-fi thrillers and animated family films will begin in earnest. Hollywood’s big blockbuster may be still be a week or two away, but we have a little entertainment of our own to share, with this week’s News in Review.

Coming soon to a global theater near you: physician payment disclosure. The European Federation of Pharmaceutical Industries and Associations (EFPIA) is rolling out an education program to help companies prepare for its financial disclosure requirements. In January, companies will have to collect, and subsequently disclose, payments made to healthcare professionals and healthcare organizations. The education program, which will include webinars, leaflets and videos, will focus on current best practices and highlight how companies across Europe are preparing for the disclosures.

Look for sequels to be a popular choice for audiences this summer (How to Train Your Dragon 2, 22 Jump Street), but don’t expect GSK to be excited about another sequel on the anti-bribery front. Polish authorities are accusing the company of bribery, and the company has launched an investigation into bribery allegations in Jordan and Lebanon. In Poland, the company is accused of paying doctors for prescriptions, and disguising the payments as speaker fees. According to Polish authorities, a dozen doctors were paid fees for presentations they never delivered. GSK conducted its own investigation, saying the payments seem to be linked to one employee and that employee has been disciplined.

In Jordan and Lebanon, GSK began investigating allegations of bribery after a whistleblower contacted the company. The investigation is focused on allegations that bogus speaker fees were paid to physicians; free product was offered for the physicians to sell to patients; and a physician was allowed to exchange a business class plane ticket economy class tickets so his family could accompany him to a medical conference.

Corporations should expect even more focus on FCPA enforcement this summer and in coming years, especially now that global agencies are pooling enforcement resources. Speaking at a conference of the New York City Bar Association, two former government fraud officials, one formerly with the SEC and one formerly with the DOJ, warned that the two agencies are adding to the penalties if companies don’t cooperate with the investigations or try to obstruct the process.

Senator Grassley is planning a new whistleblower production and he is turning to his colleagues for help. The Senator announced he intends to form a Senate Whistleblower Protection Caucus to help ensure whistleblower protection laws are enforced. The plan is to recruit colleagues for the caucus throughout the year, with the goal of launching the new production at the start of the new Congress.

The rules on providing food for pharmaceutical and medical device company meetings have changed, but rather than walk away from the business, some restaurants, like Fogo de Chao, are taking a more creative approach. Leo Jakobson, editor for Successful Meetings, says the Brazilian steakhouse keeps the menus modest and informal by focusing on meals served on skewers, and all of the locations offer private dining rooms for up to 120 participants.

And that’s almost a wrap…at least for this version of the News in Review. The summer season is a great time to reconsider the impact your compliance training has had on your audience. Compliance rules, guidance and best practices are evolving, and we’re expanding the PharmaCertify™ list of mobile training solutions to keep pace with those changes. Through the release of new titles, like Understanding Global Physician Spend Transparency, and updates to existing modules like The Sunshine Act: The Federal Physician Spend Disclosure Law, PharmaCeritfy™ offers the training where your reps need it most – in the field and at their fingertips.

Have a great week everyone! We’ll see you at the movies.

News Week in Review, April 15, 2014

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Wisconsin seeks to harmonize health records, a Vermont legislator wants an exemption for the medical device industry, and the pharmaceutical industry questions how much Sunshine has had an impact on relationships with physicians (so far).

The birds are signing, the grass is a vibrant green, the flowers are blooming…it must be time for the Super Bowl…of golf that is. The Masters, “a tradition unlike any other,” and the big daddy of all professional golf tournaments, was held in beautiful Augusta amid the standard back 9 meltdowns and whispers up and down the greens. With his usual breathtakingly long drives and birdies on 8 and 9, Bubba Watson fought off the young phenom, Jordan Spieth, to win his second green jacket. But enough about divots and drivers, tee time for this week’s News in Review is here.

In the words of the great Ty Webb, “be the ball.” It’s all about harmonization, right? Well, the governor of Wisconsin certainly thinks so. Governor Scott Walker signed a bill into law that will harmonize the state’s law regarding behavioral health records with the HIPAA Privacy Rule.

A Vermont physician and legislator, George Till, would like to take a mulligan (of sorts) on the state’s physician gift ban law. He has introduced a bill in to the state’s legislature for an exemption to allow medical device companies to provide food and drink to doctors at seminars and other events sponsored by medical device companies. According to Till, physicians really need to have a “hands on” experience to familiarize themselves with a medical device. Till is a supporter of the state’s gift ban, and he doesn’t believe that his bill is in opposition to the principle of the law.

Are conflicts of interest the sand trap of the CME world? At a meeting of the American College of Cardiology, ACCME president, Murray Kopelow, spoke about the ACCME’s conflict of interest requirements. Kopelow said the ACCME is “very precise” about determining when a conflict of interest exists. The organization evaluates whether the individual: a) has a financial relationship with a defined commercial interest and b) has the ability to control the content of CME relevant to that relationship. The content of accredited CME must be valid and free of commercial interest as defined by the ACCME. Kopelow is concerned about criticisms that ACCME’s standards are hindering innovation. He says this was not the intention and special guidance has been created for those working in discovery.

Takeda and Lilly were recently assessed one heck of a penalty stroke. The two companies were ordered to pay $9 billion by a federal jury for failure to disclose the cancer risks associated with use of the drug Actos.

The FDA is not quite sure what approach to take to the proposed safety prediction and mining tool intended to help assess drug adverse event safety signals. The project was initially announced in April of 2013, but by September it was put on hold due to funding concerns. On March 31 of this year, the FDA again announced it was again looking for an outside partner for the project, but just three days later they changed their minds. The agency provided no reasoning for the latest cancellation, only saying that it would “re-advertise the contract solicitation at a later date.”

What would a Week in Review be without one story about the Sunshine Act? During PhRMA’s annual meeting, leaders from various companies said the Act was having no effect on how their companies interact with physicians. While doctors have not shut the door on the industry, Bob Hugin, PhRMA’s board chair, is concerned that once published, the Sunshine data could be mischaracterized by the public and cause the physicians to reconsider how they do business with the industry. Hugin says companies must take a proactive approach to ensure the data is presented in the correct context.

As we approach the 18th green for this issue of the Week in Review, we’ll finish with a brief word about the expanding curriculum of PharmaCertify™ compliance training solutions. If global transparency is on your radar, we are adding Understanding Global Physician Spend to our lineup of customizable off-the-shelf eLearning modules. The module covers the EFPIA Code of Transfers of Value, as well as specific country laws, like the French Sunshine Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information and to see a content outline.

Have a great week everyone!

News Week in Review, April 8, 2014

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China shifts its focus to medical device, the Arkansas Attorney General petitions the state’s Supreme Court to reconsider its reversal of the Risperdal verdict, GSK dismisses employees for violating expense rules, and a new study raises questions about conflicts of interests for medical school leaders sitting on the boards of pharmaceutical companies.

Ah yes, the glittering dresses, the suave tuxes, the perfectly coifed hair. No, we’re not talking about the Academy Awards or the Golden Globes, this is much more important than all that. It’s almost prom season!

If your Facebook, Twitter or Instagram isn’t littered with pictures of your kids and their cronies in their formal finery yet, it’s just a matter of weeks. You can take some small amount of solace knowing all those happy smiling faces will one day be questioning their choice of fashion or hairstyle. C’mon, you know you did. (Let’s just say there were some very unfortunate prom fashion choices made in the 70’s and 80’s by members of the News Week in Review staff.) As we wax poetic about proms of yore, let’s also look back at the compliance week that was, in this week’s News Week in Review.

First on the dance floor is news that China intends to toughen penalties for corporate malpractice against medical device companies. The country will segment devices into three categories based on their potential risk to consumers. The new rules are set to take effect in June, and the top fine for selling illegal medical devices will increase to 20 times the value of the device.

Not wanting to feel like a wallflower, the Attorney General of Arkansas is asking the state’s Supreme Court to reconsider its reversal of the $1.2 billion verdict in the Risperdal case. The court ruled the state had misapplied the state Medicaid fraud law when it tossed the verdict, and even said the law was codified incorrectly. The Arkansas Code Revision Commission voted to provide the AG with an analysis comparing the law as written to how it was written into Code. The AG says the analysis may be helpful in obtaining a new hearing.

The chaperones seem to be working hard at GSK. The company has dismissed several individuals for violating company expense rules. The company did not comment on the number of individuals involved, but did say monitoring efforts in China have increased, and that irregularities are always investigated. Emails reviewed by the Wall Street Journal indicate the company is also investigating allegations of bribery in the Middle East. The emails focus on activities occurring in Iraq, including the hiring of state employed doctors as medical representatives while those doctors were still working for the government.

A former GSK sales representative in China tells the Financial Times that kickbacks to doctors there were widespread. According to the former rep, domestic and foreign firms routinely paid kickbacks to doctors to achieve their sales targets, and the sales model at GSK was no different than those of its competitors. GSK called the behavior “completely unacceptable,” but as AstraZeneca’s CEO pointed out, even a tough compliance program can’t stop an employee determined to stray.

A new study finds that the leaders of medical schools and hospitals are being paid handsomely for sitting on the boards of pharmaceutical companies. The study found that of the 50 largest companies, 40% had at least one board member who was in a position of leadership at an academic medical facility. The average total compensation for these individuals was over $300k per year. The study raises the potential for a conflict of interest. For example, the president of Yale’s medical school receives nearly $300k from Abbott, but a spokesperson from Yale says the doctor would not make decisions about formularies, clinical trials, or drug samples, when Abbott is involved. Several other medical schools made similar comments regarding leaders of their medical facilities who receive compensation from pharmaceutical companies.

As we cue the last song on this week’s playlist, we’ll take this opportunity to let you know the PharmaCertify™ list of compliance modules and mobile apps is expanding. If global transparency, including the EFPIA Code and French Sunshine Act, is on your radar, we’ve added Understanding Global Physician Spend Transparency to our curriculum of customizable eLearning modules. To learn more about the module, or any of topics, contact Sean Murphy at (609) 466-2828, ext. 25.

Have a great week everyone.