Week in Review, September 30, 2014

PhRMA and the DOJ argue the details of the Integrilin case, sentences and a fine are handed down in the GSK Chinese bribery case, more elected officials weigh in on the removal of the CME exclusion from the Sunshine final rule, and the OIG raises concerns over drug coupons and the potential for kickbacks.

The cosmos (and Starbucks – welcome back Pumpkin Spice latte) say fall is officially upon us! Cooler weather is on the way, and so is pumpkin picking and that extra hour of sleep. Time to gather around the fire pit and scarf down a few S’mores! But before we lose ourselves in a soliloquy about the magical mysteries of a great corn maze, we’ll navigate the twists and turns of this week’s News Week in Review.

There’s a certain chill in the air between PhRMA and the DOJ. A few weeks back, we highlighted the story about PhRMA filing a “friend of the court” brief in a whistleblower case involving the off-label promotion of the heart drug, Integrilin. The brief presented the claim that the whistleblower’s arguments raised free speech issues and the organization asked the court to reject the whistleblower’s claims . In a response, the DOJ said PhRMA’s brief did not establish a First Amendment violation. In fact, according to the agency, no precedent existed to support PhRMA’s argument that the False Claims Act could not have been implicated. PhRMA shot back, saying for a person’s speech to knowingly cause a false claim to be submitted there has to be a “direct causal nexus between the speech and the claim” and sharing peer reviewed journals with truthful information about an off-label use does not meet this requirement according.

The summer has ended, and so has the GSK Chinese bribery scandal, with a court levying a $500 million dollar fine against the company. The country manager for GSK and four other executives were found guilty and faced prison terms of up to four years. The Chinese court suspended the sentences, and declared that the country manager, a British national, could be deported. According to the court, all of the country manager and executives pled guilty and had no plans to appeal the verdict. The fine imposed on GSK is the highest fine the Chinese government has ever imposed in a bribery case.

On the Sunshine front, U.S. Representatives Michael Burgess and Frank Pallone sent a letter to CMS expressing concern over the removal of the CME exclusion from the final rule. The two representatives say the current rule provides a clear exemption for payments and transfers of value related to CME, while the proposed changes are ambiguous. Burgess and Pallone ask CMS to carefully consider the comments they have received from stakeholders about the proposed change. Representative Burgess also teamed up with Representative Allyson Schwartz to introduce legislation to exempt textbooks, indirect CME payments and journal articles from the Sunshine Act’s reporting requirements.

Industry trade groups are bobbing for an explanation, again, as to why nearly one-third of data submitted to Open Payment was removed from the system. PhRMA, AdvaMed, and BIO sent a letter to CMS reiterating concerns that the agency still had not provided an explanation as to what happened to the data. The groups are hopeful that the issue can be resolved quickly, so the public can be confident in the accuracy of the data.

According to a report from the OIG, the use of drug coupons could lead to kickback violations. The OIG investigated the use of coupons to purchase drugs covered by Medicare. Nearly 7% of senior citizens reported using coupons to purchase drugs covered by Medicare Part D. Coupons cannot be used to purchase items covered by Medicare Part D and inducing consumers to do so can be considered a kickback. The agency found inconsistencies in how drug companies implemented safeguards on their coupons. Printed coupons tended to have language advising consumers the coupons could not be used for Part D purchases, but only 80% of web coupons included the same language. In addition, nearly one-third of manufacturers surveyed did not include eligibility information for the pharmacists. The OIG recommends CMS work with drug makers to improve the process of identifying patient enrollment in Medicare Part D, and to improve the reliability of pharmacy claims.

FDA’s social media guidance left PhRMA feeling a little chilly. In comments submitted to the FDA, the organization expressed concern that the guidance discourages manufacturers from sharing meaningful information with patients on social media networks. According to the comments, the guidance, as written, places undue responsibility on the manufacturers for what users say about the products.

With that, we close out the post autumnal equinox edition of the Compliance Week in Review. Have a great week everyone and enjoy the colors of fall!

Week in Review, September 17, 2014

A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant company, the FTC accuses two companies of trying to stymie generic competition for Androgel, and a collection of advocacy groups ask CMS for an indirect payments exemption.

Ahoy there mateys! Stand fast, secure the rigging, and let us hear your best “arrr.” Yes, “Talk Like a Pirate Day” is on the horizon. As you prepare to weigh anchor and hoist the mizzen, we strongly recommend you avoid the parrot on the shoulder idea – that didn’t end well for one of the old salts here at the Week in Review offices last year. The big day isn’t until Friday, so we’ll fill the time with this week’s Compliance News in Review.

It’s not the amount of treasure involved, but rather the type of treasure, that may be more influential in the decisions made by FDA panel members when they decide which drugs to recommend for regulatory approval. A recent study found that panelists who have financial ties only to the drug manufacturer seeking approval are 1.5 times more likely to vote favorably for the company than members with no ties. However panelists who have ties to the company seeking approval and its competitors are no more likely to recommend for approval than those panelists who have no ties. Panelists with multiple relationship may not have a sense of loyalty to any one particular manufacturer. In addition, panelists who serve on advisory boards are more likely to approve a drug than panelists who have research or consulting relationships with the manufacturer.

A physician and spinal implant company have found themselves on the wrong end of a hornswaggle claim by the Department of Justice. The agency has filed a False Claims Act suit against a Michigan neurosurgeon, as well as spinal implant company, Reliance Medical Systems, and two of its distributorships. The company is accused of paying kickbacks through physician-owned distributorships (PODs). The government alleges that the company set up the PODs to induce physicians to use its spinal implants. The physician involved received payments through a POD in which he had an ownership stake. He is also accused of performing unnecessary procedures on patients who did not need spinal implants.

The Federal Trade Commission (FTC) is suing Abbvie and Besins Healthcare for running a rig and trying to prevent generic competition for the product Androgel. The agency claims the companies filed baseless patent infringement lawsuits in an effort to prevent potential generic competitors from entering the market. While the lawsuits were pending, Abbvie then entered into a pay-for-delay deal with Teva in order to postpone the launch of its generic version of the product. The FTC is asking the court to declare that Abbvie and Besins Healthcare violated the Federal Trade Act, and is seeking disgorgement of profits.

The mutiny against indirect payment disclosures under Sunshine continues to grow. A collection of 64 patient advocacy groups sent a letter to CMS requesting an exemption for indirect payments to the groups. The letter claims drug and device manufacturers have no discretion on how funds provided to patient advocacy groups are directed. It also suggests that the process of determining how a manufacturer’s funds are allocated places an unnecessary administrative burden on the groups.

As we heave to on this week’s journey into the world of compliance, we end with a question: arrr your sales representatives prepared with the up-to-date content on topics like the Sunshine Act, HIPAA, and Good Promotional Practices? The PharmaCertify™ suite of solutions offers your team compliance-focused information where and when they need it most – in the field and at their fingertips.

Have a great rest of the week everyone.

Week in Review, September 10, 2014

PhRMA pushes for dismissal of Integrilin off-label case, a recent FCPA settlement reveals a shift in DOJ thinking, European companies are not sure how to handle informed consent with EFPIA, and another organization wants CMS to keep the CME exemption in the Sunshine Act Final Rule.

Cue the heavenly choir; all is right with the world once again. Football season is here! The college season kicked off with some unexpected upsets, unexpected blowouts (Johnny Who? Texas A&M is here to play, y’all!), and even disruptions due to weather. The pros started the season with a kick this past weekend. The next several months are sure to be full of excitement as we get our gridiron on. For now, it’s back to the real world, as we take a look at the latest in compliance-related news with this week’s compliance News in Review.

Kicking off this week edition is PhRMA and its request to a California federal court to dismiss an off-label case on First Amendment grounds. The suit was filed by a whistleblower who alleges the three companies violated the FDCA by using truthful, off-label statements to promote a drug. PhRMA says the claim was nullified through the Supreme Court decisions in Sorrell v. IMS and the U.S. v. Caronia. According to the organization, healthcare professionals need accurate, up-to-date information about uses of medication, and neither the government nor the whistleblower alleged that the information provided about the drug was inaccurate.

The recent Smith and Wesson FCPA settlement reveals a couple of new additions to the government’s playbook, which businesses might want to note. First, the case appears to be signaling a shift in the DOJ and SEC’s focus on “high value targets” to those involving small and mid-size companies. Next, in the charges against Smith and Wesson, the internal controls violations centered on the company’s lack of an adequate compliance program, rather than financial documentation. The government noted that there was a policy prohibiting bribery in place, but the company had no process for ensuring the policy was followed.

A recent article from FCPA Professor lists four attributes of a strong compliance program that can be gleaned from a successful football program. First, understand the playbook. Effectively communicating the playbook is the first step toward becoming a successful team. Likewise, FCPA training should be executable by all employees. He suggests companies don’t need to train employees to be FCPA experts, but rather, provide them with “FCPA goggles” by which they can discern if actions are potentially problematic. Second, execution by all team members is key. More FCPA violations occur from the actions of employees doing the day-to-day work, rather than those in the C-suite or Board. Third is having a flexible playbook. A company needs to take a look at its compliance risks, and manage its own risks, not those of another company. Last but not least, play hard, but not too hard. A business can run into issues (penalties) when it competes too aggressively.

Tackling informed consent in regards to the EFPIA Disclosure Code is proving to be challenging for many companies. Data privacy laws in European countries require that companies obtain consent from healthcare professionals (HCPs) and healthcare organizations (HCOs) prior to publishing any data about transfers of value between the company and HCPs or HCOs. To complicate matters, companies also need to manage consent for direct and indirect payments. At a recent aggregate spend conference, audience members were polled as to how their company planned to handle managing consent. Most of the audience was still unsure of how it would be handled and nearly 20% said their company planned to manage consent directly, as opposed to turning it over to a third party.

The CME Coalition is jumping on the pile with comments regarding CMS’ proposal to eliminate the CME exemption from Sunshine’s Final Rule. The Coalition says the idea of eliminating the exemption is problematic because it requires manufacturers to report payments if they become aware of the identity of the payment recipient(s) within 18 months of the grant. In its comments, the organization suggested that CMS keep an explicit definition as to what constitutes accredited and certified CME, and revise the language in the CMS exclusion to be more specific.

The clock is ticking down on this edition of the Week in Review. We close with the suggestion that if your 2015 compliance training playbook needs refreshing, the PharmaCeritfy™ suite of compliance training solutions offers the eLearning modules and mobile apps you need to prepare your team to compete in today’s regulatory environment.

Have a great week everyone!

Week in Review, August 27, 2014

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

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

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!

News Week in Review, July 29, 2014

Physicians find confusion instead of data on Open Payments, a judge refuses to dismiss the false claims case involving Thalomid, FedEx is facing arraignment this week for shipping illegal drugs, and the SFO is teaming with the Chinese government on the GSK case.

Time to deck the halls and break out the It’s a Wonderful Life DVD. It’s Christmas in July! While the dog days of summer may seem an odd time for sugar plum fairies to be dancing through our heads, we can at least crank the air conditioning, don a really ugly reindeer sweater, and let our imaginations run wild. It’s time to rip the paper and ribbons off this week’s Compliance News in Review.

Some doctors unwrapped a confusing error message when they tried to access information in the Open Payment system last week. July 14th marked the first day physicians and teaching hospitals could access the information that has been reported about them in the system. A number of physicians reported that it took them up to an hour just to log on. Once logged in, some saw a rather ambiguous error message; “You have the following errors on the page. There are no results that match the specified criteria.” Although the physicians were unsure whether this was a bug in the system, or it really meant no payments were in the system, CMS said the message is clear and anyone with questions should call their helpdesk.

The sleigh ride isn’t over yet for Celgene. A federal judge refused to dismiss a false claims case brought against the company by a former salesperson. The case has drawn interest because it raises questions about when manufacturers can discuss the off-label use of products with physicians. According the whistleblower, initial marketing efforts for the drug Thalomid were focused on off-label uses. The company asked for a dismissal, saying the plaintiff failed to state a plausible claim. The judge disagreed, saying the plaintiff’s claims did lay out a sufficient case of wrong doing and that Celgene was “belied by its own evidence.”

The director in the charge of the lab where employees were potentially exposed to anthrax has resigned. Lax adherence to safety protocols in the lab led to the possible exposure. Luckily no one fell ill. An investigation into the incident has found that several other labs, some dealing with dangerous germs, were also not following proper safety protocols. CDC chief, Tom Frieden, said disciplinary action will be taken against those intentionally breaching safety protocol, or those who know of safety breaches but do not report them.

One of Santa’s helpers, FedEx, will be arraigned in federal court this week. The company was indicted for shipping drugs for illegal pharmacies. The government claims it repeatedly warned FedEx about shipping drugs for the pharmacies. FedEx says it ships millions of packages and cannot be responsible for policing the contents of each one. The company says it repeatedly asked for a list of shippers involved in shipping illegal prescription drugs, but was never provided one. United Parcel Service signed a non-prosecution agreement last year over similar charges.

The Serious Fraud Office (SFO) and the Chinese are caroling together in the GSK investigation. SFO chief, David Green, says this is the first cooperative case between the agency and the Chinese government. Green visited China earlier in the year, and said the Chinese government has a desire to deal with bribery and corruption. The SFO’s interest in GSK has expanded beyond the company’s business in China, and the agency is seeking help from whistleblowers regarding reports of bribery in the Middle East and Europe. GSK chief Andrew Witty says he remains “very concerned” about bribery allegations in China.

Even if you didn’t bother to break out the decorations for Christmas in July, planning for the actual, year-end festivities will be here soon after summer ends. And so will, the need to make your 2015 compliance training plans. The PharmaCertify™ suite of commercial compliance training solutions offers the up-to-date modules and mobile apps your staff needs to help them integrate good compliance practices into their daily activities.

Have a great week everyone, and happy holidays!

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