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!

Week in Review, July 22, 2014

The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal pharmacies, and industry funding for CME continues to decline.

With summer in full swing, Major League Baseball took a break from the pennant races for its annual showcase of the best and brightest stars from both leagues…and the ratings were up. In what seems to be the trend lately, the American League came out on top and National League fans were left lamenting the fact that should their team make it to their World Series, they will once again be denied the coveted home field advantage (strange rule indeed). Now, as trade talks heat up and races tighten, we step up to the plate with this week’s News in Review.

First up, we have news from the state that hosted the All Star Game, Minnesota. The Minnesota Board of Pharmacy released a memo confirming that 2014 payments to nurse practitioners, physician assistants, veterinarians and dental technicians must be reported in May 2015. The Board advised manufacturers to begin tracking data for these professionals since it expected the legislature to require companies to report those payments.

Batting second this week is the always confusing topic of social media. The FDA recently issued an Untitled Letter to Gilead and a Warning Letter to Zarbee’s Naturals regarding the company’s use of social media for product promotion. In its letter to the company, the FDA cited an ad that used Google’s AdWords. The ad neglected to provide risk information, and the drug was misbranded. The ad also did not include the generic name of the product and only featured the brand name in a couple of URLs listed in the ad. Zarbee’s Warning Letter focused on the use of Facebook “likes.” The FDA equates “likes” top promotions and the company “liked” several customer testimonials on its page.

Companies that manufacture products for human use aren’t the only ones running afoul of the FDA’s promotion regulations. A Warning Letter was issued recently to the French pharmaceutical facturer, AB Science, for the off-label marketing of a veterinary drug. The letter cited several off-label statements on a product website. The FDA also noted that the company neglected to list important safety information on the product website and other promotional material.

The federal government took a swing at FedEx recently when a federal grand jury indicted FedEx for shipping drugs for illegal pharmacies. According to prosecutors, the company was warned for over a decade that they were shipping drugs for illegal pharmacies, but that those warnings went unheeded. Rather, the company “departed from its usual business practices” to continue shipping the drugs. According to prosecutors top managers at FedEx approved the continued shipping to known illegal pharmacies. A senior vice president for FedEx said the company was innocent of the charges levied against it, and would plead not guilty.

It’s a single for industry support of CME…a single digit decline in funding that is. According to the ACCME’s Annual Report, industry funding of accredited CME dropped by 1.9% in 2013. Support from industry represents 27% of all CME income. This is a far cry from 2008, when industry funding represented almost half of CME funding. Physician attendance at CME events was down in 2013 by just over 4%, but attendance by non-physicians was up by 5%.

As we wind down this week’s version of the Week in Review, we offer one last pitch about the importance of reviewing your Sunshine Act training needs – particularly in light of the ongoing activities around Open Payments registration and data review. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, is designed to bring your team up to speed on reportable and excluded expenditures, and the information required for submission to CMS.

Have a great week everyone!

Week in Review, July 9, 2014

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

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!

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