compliance

Week in Review, December 10, 2014

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

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

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

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

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

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

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

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

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

Week in Review, November 26, 2014

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Time to head over the river and through the woods to grandmother’s, or somebody’s house, for turkey, gravy, stuffing and pumpkin pie! Thanksgiving is almost here! The Week in Review staff is excitedly looking forward to a day of family, football (Go Eagles!) and tryptophan. Before we start the food prep and festivities though, we need to take care of a little business first; this week’s Compliance News in Review.

Doctors in Michigan aren’t just talking turkey when it comes to the context that surrounds public disclosure of physician payments under Sunshine. A Michigan news outlet gave the physicians that received the most in payments a chance to provide that context. The five doctors received payments in the hundreds of thousands of dollars. For most, the payments represented royalties for devices they had invented. One physician received in excess of $500K for clinical research. The money did not go to the doctor, but to the clinic for which he works, and he is strictly a research physician. Another received almost $350K in payments for consulting and speaking. This physician is a plastic surgeon who runs a training center to teach other physicians. He says consulting pays 1/10th of what he would receive if he were working in his practice, and therefore is not financially beneficial. All of the doctors profiled said they believed physicians should be upfront with patients about their financial relationships with life sciences companies.

A jury in West Virginia found Takeda destroyed documents related to the drug Actos and ordered the company to pay $155,000. The case was brought by an individual who claimed the destruction of the files prevented him from proving his case that the company failed to provide adequate warnings about the cancer risks associated with the drug. A Takeda spokesperson said the company is considering an appeal.

Recoveries from False Claims Act cases are stuffing the federal treasury. The Department of Justice announced that nearly $6 billion was recovered through the False Claims Act in fiscal year 2014. Housing and mortgage fraud represented the largest amount of recoveries at $3.1 billion. Healthcare fraud recoveries were not too far behind at $2.3 billion. Whistleblower cases resulted in nearly $3 billion in recoveries and the government paid out $435 million in whistleblower awards.

The OIG has released a report of the top challenges and issues facing HHS during fiscal year 2014. The report lists several issues related to Medicare, Medicaid and the federal healthcare exchanges. Number ten on the list, ensuring the safety of food, drugs, and medical devices, should be of particular note for the industry. This challenge primarily addresses problems associated with drug compounding and importation of drugs from foreign countries, but the OIG also cites drug marketing; specifically off-label marketing. According to the report, illegal off-label marketing undermines the system intended to ensure that drugs are safe and effective, and may lead to fraudulent claims for reimbursement being submitted to Medicare and Medicaid.

With that final serving of off-label news, we’ve come to the end of this holiday edition of the Compliance News in Review. Have a wonderful Thanksgiving everyone, and remember, it’s all about that baste.

Week in Review, November 5, 2014

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

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

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

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

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

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

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

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

Have a great weekend everyone.

Week in Review, September 30, 2014

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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, 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 22, 2014

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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

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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!