Compliance News in Review, April 19, 2017

The city of Chicago releases sales representative licensure rules; review and dispute time is here again; opioid manufacturers receive letters and negotiate settlements; and Australia proposes changes to its bribery law, in this edition of the Compliance News in Review.

April showers may bring may flowers, but they also bring something else…the Boys of Summer. Major League baseball is back! Much of the buzz seems to center around a former Heisman Trophy winning quarterback and his homerun prowess. Whether your team is off to a hot start (we’re looking at you Yankees fans) or surprisingly struggling (are the Blue Jays already too far out?), there’s plenty of time for the standings to change as the temperatures warm. For now, buy me some peanuts and Cracker Jack and settle in for this edition of the Compliance News in Review.

Our first story comes from Chicago, home of the 2016 World Series champion Cubs. The City has released draft rules for its pharmaceutical sales representative licensure ordinance. The initial license is $750.00. Like the rules in place for detailers in Washington DC, Chicago’s ordinance has a continuing professional education provision. Education provided by the rep’s company will not suffice in meeting the requirement unless the company applies for and receives approval from the city. The draft rules also require sales representatives to track their interactions with healthcare professionals.

April 1st was opening day for the Open Payment’s review and dispute period. Physicians and teaching hospitals are free to review recent submissions to the system and dispute items they believe are incorrect. The review and dispute period for the 2016 Program Year ends on May 15th.

Senator Claire McCaskill sent letters to a lineup of opioid manufacturers requesting that they provide information related to sales, marketing and education strategies used to promote their products. from which she wants some information. McCaskill acknowledged that most of the players in the opioid market act responsibly and she said the purpose of her investigation is to learn if any of the practices

Mallinckrodt has agreed to settle a DEA probe for $35 million. The settlement involved the company’s suspicious order monitoring program for controlled substances. The settlement is under review by the DOJ and DEA. In a statement, Mallinckrodt said it had not violated the law, and the settlement does not include an admission of liability.

Australia appears to be poised to move its bribery law up to the major leagues. Government officials there announced that several reforms were being considered to deal with bribery of foreign public officials. The reforms include the addition of a “corporate failure to prevent bribery” offence and use of deferred prosecution agreements to encourage self-reporting. Among the changes proposed, the definition of a foreign public official would include political candidates and bribery offences would extend to those that offer a “personal advantage,” not just a “business advantage.”

The anticorruption landscape continues to evolve. The PharmaCertify Compliance Foundations™ eLearning module, Global Anticorruption Laws, covers the concepts common to most anticorruption/anti-bribery laws, as well as the specifics related to laws such as the FCPA and the UK Bribery Act. In addition, our new Compliance QuickTake™, Recognizing and Reducing Third-Party Risks, covers the risks associated with working with third parties, in a targeted microlearning format.

The PharmaCertify™ team will be offering demos of our compliance training products at the Pharmaceutical Compliance Congress in Washington next week. Stop by Booth 10 in the Exhibit Hall to say hi, and while you’re there, enter our drawing to win a JBL SPLASHPROOF PORTABLE SPEAKER.

See you in Washington!

Week in Review, May 6, 2015

Connecticut delays the implementation date for its the APRN reporting law, CMS releases 2013 Medicare Part D data, the Medicines Australia Code of Conduct is approved, and lawmakers release draft legislation that includes an exclusion for reporting CME payments under Sunshine.

Avengers Assemble! The highly anticipated Avengers: Age of Ultron, opened last weekend and apparently a lot of us assembled for the opening. The film managed to land the second largest opening weekend box office numbers in history. Considering the title holder is the first Avengers movie, coming in second isn’t that much of a loss for the franchise. You won’t find any spoilers here…after all, not all of the Compliance News in Review staff have seen it yet.

The next Avengers movie is slated for 2018, but in the meantime we can look forward to 2017 and the new Guardians of the Galaxy movie…and of course, collecting spend data for APRNs in Connecticut.  The State has once again delayed the implementation date for the law, which requires drug and device manufacturers to report transfers of value to APRNs.

$103 billion: Tony Stark’s net worth or Medicare drug spending? If you answered Medicare drug spending, you are correct. CMS released data revealing the prescriptions that were covered by Medicare Part D in 2013 and the names of the doctors who wrote the scripts. The costliest drug was Nexium at $2.5 billion, and the most prescribed drug was Lisinopril (cost $300M). PhRMA said the data does not reflect the substantial rebates pharmaceutical companies pay to Medicare. The American Medical Association said the data could be misleading because the dose and strength of the medication is not included in the information. Doctors often change the dosage or strength when patients don’t respond as expected.

After extensive negotiations, the Australian Competition and Consumer Commission (ACCC) has approved Medicines Australia’s Code of Conduct. Much to the chagrin of industry critics, the ACCC went along with a change that will impose a $120 spending limit on meals and beverages provided to physicians. The “opt out” loophole has also been removed. The Code goes into effect in mid-May.

Lawmakers introduced a draft legislation “sequel” that includes an exclusion for most payments associated with CME from the Sunshine Act reporting requirements. The move to exclude the requirements was applauded by the head of the CME Coalition. The legislation is part of the larger 21st Century Cures effort, and is a paired down version of a draft that was originally introduced in January. Drug makers would also be able to share health economic information about products with physicians.

With that, we have reached the end of this week’s compliance tale. Speaking of the Medicines Australia Code of Conduct, the new PharmaCertify™ module, Global Transparency: Reporting HCP and HCO Transfers of Value includes up-to-date covering the policy, as well as the EFPIA Disclosure Code and Loi Bertrand in France. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information.

Have a great week everyone!

Week in Review, April 27, 2015

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

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

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

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

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

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

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

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

Farewell for now dear friends.

Week in Review, 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!

News Week in Review, March 24, 2014

GSK plans to hire physician speakers as employees, the Arkansas Supreme Court reverses the Risperdal verdict, SciClone sets money aside for an FCPA settlement, and Canada strengthens its Food and Drug Act.

Are your brackets ruined? You’re not alone. They don’t call it March Madness for nothing! Take heart though, most NCAA fans are in the same boat, and that one billion dollars from Warren Buffet for a perfect bracket can still be yours…next year. As you work through the carnage of your tournament picks, we offer the solace of a week’s worth of compliance news, with this week’s News in Review.

Outside physician speakers have suddenly been delegated to the bench at GSK. The company announced it plans to hire physicians and scientists to conduct product-focused educational programs rather than pay external speakers. Bringing the speakers in house should lighten the company’s Sunshine Act reporting load, but some experts question whether the move is worth the risk of having the speakers’ credibility and qualifications questioned.

Upon video review, the ruling in the courtroom has been overturned. The Arkansas Supreme Court has reversed the $1.2 billion Risperdal verdict against J&J and Ortho-McNeil-Janssen. The companies were sued and ultimately fined for violations of the state’s Medicaid Fraud False Claims Act (MFFCA) and Deceptive Trade Practices Act (DTPA). In an appeal, the companies argued appeal that the court erred when it ruled on the MFFCA and DTPA claims. The justices agreed on the MFFCA since the law is written to apply to a healthcare facility and not a pharmaceutical company and a majority of them agreed that the DTPA fines were not warranted.

No cash, no foul? A recent ruling in a case involving GSK and Teva seems to suggest so. A U.S. District Court judge ruled that since a settlement between the two companies did not involve a cash payout, the arrangement did not violate antitrust laws. As part of the settlement, GSK agreed to allow Teva to sell a chewable form of one of its drugs prior to the patent expiring while agreeing not to sell its own authorized generic of the drug. The Federal Trade Commission had argued that those types of arrangements have their own value.

SciClone is keeping some key resources on the bench and ready to be utilized when needed. The company announced it is reserving $2 million for penalties related to an ongoing FCPA investigation. In its annual report, the company said a settlement was probable.

A full-court press to strengthen Canada’s Food and Drug Act is in effect. The Canadian Parliament will debate a bill that would give the country greater ability to regulate drugs even after they are approved. The bill will give the Health Minister the power to recall unsafe products and require changes to labels.

If you thought NCAA rules were confusing, try figuring out the international physician spend transparency requirements. At the recent Disclosure Summit, an expert discussed the EFPIA’s Code of Disclosure on Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations (hence forth know as the Code). The EFPIA Code must be integrated into its member organizations’ code by the end of the year. That’s 33 different organizations! Further complicating the situation for the manufacturer are conflicts between the Code and existing laws in countries like France and Portugal. EFPIA is expected to release more guidance on addressing these conflicts at the end of March.

As the final buzzer sounds on this week’s Review, we offer a reminder that the PharmaCertify™ suite of customizable off-the-shelf eLearning modules and mobile apps provide the touch point learning opportunities your reps need to stay up-to-date with the latest commercial compliance information and good promotional practices.

Have a great week everyone!

News Week in Review, November 25, 2013

The Sunshine Act’s payment reporting is still a worry for physicians, the FTC monitors its pay-for-delay deals closely and the U.K. Bribery Act fails to boost confidence of small and medium enterprises – all in time for Turkey Day.

Gobble, Gobble everyone…Thanksgiving is this Thursday! (and for our Canadian friends, we hope you enjoyed your Thanksgiving back in October!) We at the News are excited and busy making those last minute trips to the grocery store to prepare for the feast with family and friends. Let’s face it though, sometimes all the togetherness can be a little “stressful,” and there’s no better way to deal with the stress than comedy. Laughter is the best medicine right? So, while we serve up the week’s main course, the News in Review, we’ll add a side of corny jokes to the plate for your Thanksgiving festivities – we’ve put the punch lines at the end of each paragraph, just to build the suspense.

Why did the turkey cross the road?

The Sunshine Act payment reporting continues to be a concern for physicians, particularly, the accuracy of the reported data and the ability to address inaccuracies within the 45 day dispute timeframe. How those payments appear to the public also weighs heavily on physicians’ minds and could lead to changes in how they interact with the industry.  According to HealthLeaders Media author, Greg Freeman, concern over having their name associated with industry payments may cause physicians to limit their consulting or speaking engagements.

It was the chicken’s day off of course.

If April showers bring May flowers, what do May flowers bring?

Targeting pay-for-delay deals will continue to be a top priority for the Federal Trade Commission, according to FTC Competition Bureau Chairwoman Deborah Feinstein. The agency has two pay-for-delay cases currently in litigation and Ms. Feinstein says it will continue to monitor filings submitted under the Medicare Prescription Drug Improvement and Modernization Act.

Pilgrims (okay, we admit it that “May flowers” pun is best delivered through the spoken word and falls apart when written).

Why do turkeys gobble?

The Drug Quality and Security Act received its senatorial stamp of approval last week and has been sent to the President for his signature. The bill was created to clarify the law around drug compounding and compounding pharmacies. It includes a drug track and trace requirement to address the issue of counterfeit drugs entering the marketplace. Beginning January 1, 2015, manufacturers and distributors that transfer ownership of products will have to provide a document showing the ownership trail of the product.

Because they never learned table manners.

What kind of music did the pilgrims listen to?

More than half of accountants surveyed by the Association of Chartered Certified Accountants (ACCA) agree with the statement that the U.K. Bribery Act has failed to increase the confidence of small and medium enterprises. Only 17% percent of the respondents say the U.K. Bribery Act has given confidence to small and medium enterprises to resolve corrupt practices. While 48% say small and medium enterprises are likely to face corruption risks overseas, only 43% say anti-bribery is something they consider when looking at overseas business opportunities.

Plymouth Rock.

What is the best thing to put into a pie?

Louisiana’s Attorney General announced an $88 million settlement with 25 pharmaceutical companies over allegations of overcharged state Medicaid system. The settlement brings a 2010 case involving 109 manufacturers to a close. Total recoveries in the case were $238 million. The companies were accused of inflating Average Wholesale Price, violating the Louisiana Unfair Trade Practices and Consumer Protection Act and violating the state’s Medical Assistance Programs Integrity Law.

Your teeth!

Well that brings us to the end of this week’s News Week in Review and thankfully, the end of our lame jokes. Happy Thanksgiving everyone! As always, we’re grateful that you’ve taken a few minutes of your time to read our weekly review.

See you right back here next week!

News Week in Review, October 14, 2013

An industry watchdog group raises concerns about pay-for-play, the Supreme Court considers medical devices, one company claims its trade secrets were sent overseas and a critique of off-label promotion is, well, criticized.

“In fourteen-hundred and ninety-two, Columbus sailed the ocean blue”…certainly one of the more effective pneumonic devices from our younger days. So it is that today we celebrate the journey that would lead Mr. Columbus to “discover” the Americas. Unless of course you’re Canadian, in which case…Happy Thanksgiving! There is much to celebrate in North America today, but before you dig into the turkey and stuffing or take advantage of the Columbus Day sales at the local mattress emporium (nothing says “woo hoo, America was discovered!” like a new mattress), we set sail with this week’s News Week in Review.

The discovery of emails about meetings between government regulators and industry executives has raised concerns about the relationship between the two groups. The emails reveal that since 2002, pharmaceutical companies paid their way into the IMMPACT (an organization dedicated to improving clinical trials for new pain treatments) meeting, where they were able to discuss clinical trial procedures with regulators. The industry watchdog group, Public Citizen, says this raises concerns of a pay-for-play arrangement, in which drug companies could buy access to regulators, other health officials and academics. One of the founders of IMMPACT acknowledged that the email messages could appear problematic on the surface, but no one has complained about pharmaceutical companies paying for representatives to attend the meetings.

The U.S. Supreme Court could be exploring a case of a patient’s ability to sue a device maker under state laws when a problem with an FDA-approved device occurs. The case involves an Arizona man who has sued Medtronic over a pain medication pump which he claims left him paralyzed. At the time the man was using the pump, the device was approved by the FDA. The device was eventually removed from the market following a warning from the FDA about Medtronic’s failure to disclose all the risks. The Court has turned to the Obama Administration for an opinion on the matter.

A semi-retired Harvard doctor is suggesting that the Massachusetts legislature define a modest meal as one comparable to what one would receive at a hospital cafeteria. The doctor testified before the Committee of Public Health about a bill that would set a standard for a modest meal. He lamented the repeal of the existing meal ban and lectured about the so-called evils of pharmaceutical marketing.

Three former Lilly employees may be forced to walk the plank after they were indicted for handing over company trade secrets to a Chinese pharmaceutical company. According to the indictment, two of the employees emailed information about nine early-stage research projects to a third employee, who was also employed by the Chinese drug company. Lilly claims the company has a value of $55 million.

Fresenius, the maker of Propofol, ceased shipments of an anesthetic drug to Morrison-Dickson for several months, after the wholesaler accidently sent 20 vials of the drug to a Missouri prison for use in lethal injections. Fresenius will sell the drug to U.S. wholesalers only under the condition that they not sell it to prisons or jails. When company officials originally tried to reclaim the drug from the prison, they were told that decision would have to come from the state’s director of corrections or the governor. The state has agreed to return the vials.

In a case of the old world borrowing an idea from the new world, the U.K.’s Home Office is considering U.S. style whistleblowers awards in fraud, corruption and bribery cases. Currently, the U.K offers limited legal protections for employees who blow the whistle and the move is seen as one way to incentivize them. Some are concerned that the financial rewards will lead to bogus claims and raise questions about the credibility of a whistleblower as a witness.

A rehabilitation physician is trying to take the wind out of the sails of critics of prescribing drugs off label. Ford Vox, a physician at the Shepherd Center, responded to a recent article in the Washington Post about the number of off-label prescriptions written for patients covered by Medicare and Medicaid. Vox poked holes in the article’s assertions that off-label prescribing is inherently suspect, and that CMS has a responsibility to police physicians engaged in the practice. He notes that while focusing on one specific physician and drug, the article does not mention that the particular use is backed by research from 2006.

And so we end our exploration of all things compliance for this week. Fall has definitely arrived and as you map your compliance training curriculum for 2014, keep in mind that PharmaCertify™ offers the custom and off-the-shelf training solutions you need to help your crew navigate today’s murky compliance waters.

Have a great week everyone!