French Sunshine Act

CBI’s 9th Annual Forum on Transparency and Aggregate Spend: A Review

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

CBI’s recent Forum on Transparency and Aggregate Spend covered a variety of topics affecting the collection and reporting of aggregate spend data. The conference featured speakers from industry, government agencies, and service providers sharing lessons learned and best practices related to aggregate spend collection and data disclosure.

After a day of pre-conference workshops, the main conference began on Day Two, and it started with a bang. The keynote address, An Update on Open Payments Reporting, was delivered by Doug Brown, CMS Group Director, Data Sharing and Partnership Group, Center for Program Integrity. Mr. Brown shared statistics on the data submitted for the 2014 reporting year. 11.4 million records were received, covering 600,000 individual physicians. In a vast improvement over the previous year, 98% of submitted records were accepted. Brown attributed this improvement to the introduction of the validated physicians list (VPL) and better data matching. An analysis of rejected records is underway, and CMS is looking for ways to improve the taxonomies associated with covered recipients.

During the review and dispute period, CMS received 30,000 disputes on 25,000 unique records. The disputes were evenly distributed among the covered recipient type, with physicians representing 35% of disputes, teaching hospitals 38% and principal investigators 27%. According to Brown, disputes were evenly split between the general and research payments reports. Very few disputes were lodged against payments reported on the ownership report. The median value of total payments is 4.5 times greater for registered physicians versus unregistered physicians.

Brown also shared information regarding the anticipated enhancements to the Open Payments system. The restrictions around special characters in the text fields will be removed (cue the heavenly choir). CMS is also working to better facilitate the review and dispute process. According to Brown, many of the disputes were not true disputes, but could better be classified as inquiries. CMS is working to provide a method for distinguishing between a payment inquiry and a payment dispute. The agency is also working to enhance the ability for manufacturers to download their data from the site, regardless of the file size, and it hopes to extend this capability to covered recipients as well.

Brown reminded the group that new de minimums payment information and the list of teaching hospitals will be released on October 1st. CMS is planning more Q&A teleconferences in the future. Speaking of which, during the Q&A period following the presentation, Brown was asked about having a moderator on teleconferences to alleviate the “wild west” that currently exists when the call opens up for participant questions. He said that was something he would absolutely consider, but he prefers the conversational style of the current format.

William Killian, U.S. Attorney for the Eastern District of Tennessee, and Jacob Elberg, Chief, Healthcare and Government Fraud Unit, of the U.S. Attorney’s Office for the District of New Jersey, also presented on behalf of the government. They discussed current trends in government enforcement. Mr. Killian said emerging enforcement trends in his and other offices involved fraud related to Medicare Part D, lab services, hospital services and hospice care. He noted that the civil and criminal prosecutors are often involved in parallel prosecutions. Mr. Elberg referenced a continuing trend in his office involving the prosecution of kickback cases. He said those cases are typically at the individual practitioner level, and occur locally or globally. Cases that involve activities outside the U.S. can implicate the FCPA and his office shares information with FCPA fraud units. Elberg also discussed other continuing trends involving FDCA prosecutions, including those involving off-label promotion and cGMP violations.

Rounding out the “law-focused” presentations for the day was a presentation about state laws by Brian Bohnenkamp of King & Spalding. Mr. Bohnenkamp led off by discussing federal pre-emption and how it relates to state reporting. He noted that there are times where the reportable items under federal law are not reportable under state law (and vice versa), and reminded the audience of the criteria for pre-emption under the Sunshine Act. He suggested that decisions on whether pre-emption should be applied to a particular payment should be made on a case-by-case basis. He also noted that they are seeing more companies take advantage of federal pre-emption in reporting under state laws, and used the example that a number of companies did not have anything to report under Minnesota’s law due to that pre-emption. Bohnenkemp also highlighted the recent exemption in D.C.’s detailer licensing requirement for individuals who are involved in detailing for “less than 30 consecutive days per calendar year,” and he reviewed prescription drug pricing transparency proposals in a handful of states – one example being Massachusetts, which still had not provided guidance about quarterly meal reports reported under that state’s law.

The majority of the rest of the Day Two sessions focused on data and processes directly related to interacting with the Open Payments system. Sessions and panel discussions covered topics such as leveraging the data within the organization; using data to minimize compliance risk; and remediating data and the data attestation in Open Payments. Two key themes emerged: 1. Clean data is key (the garbage in garbage out idea) and 2. Communication with the organization and those outside the organization (your vendors and physicians) about the data is critical.

A number of speakers and panelists in the sessions stressed the importance of consistency in names, addresses, and format for physician ID numbers across the various in-house and vendor systems that house spend data. A periodic review of the data is an important best practice to deal with any issues along the way. Most panelists and speakers felt that a quarterly review was an achievable goal. More frequent reviews would be ideal, but could prove a challenge for companies with fewer resources. In addition, companies should engage the business early and often about what the data reveals and how that information can be leveraged to reduce risk and impact sales. Communication with physicians in advance of the CMS review and dispute period was recommended. This does not necessarily mean disclosing all the data, nor pre-disclosing to every physician about whom you have data. Setting a minimum TOV threshold for pre-disclosure, or pre-disclosing only to select KOLs were suggested as means of making the pre-disclosure beneficial to both the physician and the company.

Speaking of physicians, Day Two included a panel discussion moderated by PhRMA Executive Vice President and General Counsel, John Murphy, on the physician’s perspective of Open Payments. Panelists included Dr. Maya Babu of the Mayo Clinic and AMA Board of Trustees member, and Dr. David Barbe, former Chair and current member of the AMA Board of Trustees. The panelists said the main concerns of physicians are centered on the potential for bad data being presented to public, the ability for physicians to access the data, the implications of the data, and the impact the Open Payments program will have on relationships with the industry. While there have been improvements in the registration process, there are still issues with access, specifically, problems with particular browsers being able to access the site. The panelists felt strongly that being able to access the data through a site set up by the manufacturer would be helpful, or even having a sales rep provide the data personally.

The United States certainly hasn’t cornered the market on physician spend transparency. Global transparency was addressed on Day Two, predominately in a discussion group at the end of the day. On Day Three an entire morning track was dedicated to issues related to global transparency. The featured presentation (and highlight of the conference) was an address by Andrew Powrie-Smith, Director of Communication for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Mr. Powrie-Smith briefly covered the nuts and bolts of the EFPIA Disclosure Code before turning to a discussion of transparency in general. The industry believes transparency is about demonstrating that there is value in the collaboration between industry and healthcare professionals/organizations, which ultimately delivers better patient care. However, being transparent is not without its challenges. Primarily, with the exception of countries, such as France, where there are physician spend disclosure laws, managing transparency efforts in face of the EU privacy laws is challenging. The EFPIA Disclosure Code requires the disclosure of certain transfers of value at the individual practitioner level, and requires that disclosure to be made available to the public. In order to meet these requirements, companies must obtain consent from physicians to disclose private information about them. Further complicating the matter is that even if consent is given, it can be revoked at any time.

Mr. Powrie-Smith said EFPIA is currently conducting a survey regarding the industry stance on obtaining the necessary consents for disclosure of transfers of value at the individual level. Thus far, EFPIA has seen a large variance in the rate of consent across Europe. A culture shift is necessary to address the variance and the industry must take a leadership role in that shift.

The concept of gaining and managing consent was emphasized in other presentations as well. Representatives from BMI Systems shared data on the rates of consent presented by various pharmaceutical industry trade organizations at an EFPIA meeting in May. In Germany, the consent rate was 50-55%, and the industry trade organization in the country said that was about what they expected for the first year. Poland’s trade organization noted in March they were at a 20% consent rate, and Spain’s trade organization reports only a 10% consent rate. Representatives from IMS Health dug into issues with gaining consent as well. They discussed how codes and laws differed from country to country, specifically regarding the timelines for obtaining consent (e.g., at time of contract, or at any time during the reporting period); the scope of the consent (e.g., per activity type, per contract); from whom consent is required (e.g., HCPs or HCOs); and required consent documentation (paper or digital).

The 9th Annual Forum on Aggregate Spend and Transparency offered useful information for any attendee responsible for data collection, report submission, or analytics inside or outside the U.S. Beyond the nuts and bolts of aggregate spend, the presentations focused on the value of the data for the organization and the physician. Data provides insight for commercial teams and their programs, and the compliance risks for the company. Most importantly, as communicated by Andrew Powrie-Smith, transparency around spend data is important, because it reveals the benefits of the industry/HCP relationship to patients, payers and the public.

 

News in Review, August 11, 2015

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , , ,

Industry support of CME increases in 2014,  NuVasive settles False Claims charges while Mead Johnson deals with FCPA charges, and Amarin wins a preliminary injunction in its off-label case against the FDA.

The dog days of summer have certainly arrived in most of the U.S. with temperatures that are best described as hot, hot, hot! Thanks to Willis Carrier and his wonderful invention, we can at least find occasional respite from the sun’s rays and the humidity. So while you wait for a break in the heatwave, crank the A/C up a few notches, grab a cool beverage, and just chill with this edition of the Compliance News in Review.

According to a report from the Accreditation Council for Continuing Medical Education (ACCME), industry support of CME increased 2.4% in 2014. According to the report, industry support represented about a quarter of all CME revenue in 2014, whereas in 2007, that support was closer to half (46%) of CME revenue. Physician attendance at CME dropped by just over one percent, but non-physician attendance rose six percent.

The heat is off for NuVasive now that it has settled with the DOJ. The company has agreed to pay $13.5 million to settle charges it violated the False Claims Act by marketing a product for surgical uses for which it was not approved. According to the government, the company marketed its CoRoent System for several spinal surgical procedures for which it was not approved. The DOJ also claimed kickbacks, in the form of speaker fees honoraria, were paid to induce physicians to use the system. The company was also accused of paying kickbacks for physicians to attend events hosted by Society of Lateral Access Surgery (SOLAS), an organization that was entirely organized and funded by NuVasive.

Mead Johnson entered into a settlement with the SEC to resolve charges it bribed Chinese government healthcare workers to recommend its infant formula, in violation of the FCPA. According to the SEC, the company funded the payments through distributor allowance funds paid to a third-party distributor, and then directed the third-party on how those funds were to be used. Allegedly, the payments were not properly reflected in the company’s books and records.

Insys also finds itself in the doghouse; or in this case, we’ll say the duck house (okay, it’s a reach, but stay with us here). Insys Therapeutics has entered into a settlement with Oregon to resolve a deceptive marketing case. The State claims the company marketed an opioid painkiller for treating mild pain that was only approved for treating pain in cancer patients who are not responding to other types of painkillers. The State also claims the company paid physicians for writing prescriptions and used unqualified physicians to promote the product. The settlement will be split between the State and an organization dedicated to the prevention of opioid abuse, which will be selected by Oregon’s Attorney General.

So it appears, this off-label promotion dog can hunt. Amarin, the company suing the FDA over its ability to promote its fish-oil drug for off-label uses, has won a preliminary injunction against the agency. The injunction is not a final order, but for now, the FDA cannot prevent Amarin from the truthful off-label promotion of its product. The drug is approved for treating patients with very high levels of triglycerides. Amarin would like to promote the drug for use with patients that have moderately elevated triglycerides levels, despite being on a statin.

Like the Caronia decision before it, the Amarin case certainly raises interesting questions about the future of truthful off-label promotion. While a compliance training session may not be the place and time to delve into a discussion of that future, the decision does present an opportunity to discuss off-label promotion and how to address questions related to off-label use. Why not take this opportunity to launch refresher training, or distribute an updated, quick-reference communication piece? On-going reminders about what constitutes off-label promotion, and the policies your organization has in place to address unsolicited questions, are part of any effective compliance curriculum. The case also creates an opportunity to work with commercial team managers on a plan to increase the dialogue about the topic with their teams. Off-label is in the news and the training opportunities abound.

Looking Ahead: CBI’s 9th Annual Forum on Transparency and Aggregate Spend

NXLevel Compliance Team , , , , , , , , , , , , ,

The release of the first full year of data under the Open Payments Program is just around the corner, which naturally means transparency and aggregate spend are top of mind these days. Will the data be released without any issues? How will the media react?

With aggregate spend on the mind, the NXLevel Solutions PharmaCertify™ team is looking with interest at the conference agenda for CBI’s 9th Annual Forum on Transparency and Aggregate Spend. We’ve selected a few sessions of particular interest.

Here’s what caught our attention:

Strategies to Reduce Compliance Risks and Optimize Commercial Programs Using Transparency Analytics – Obviously, companies are collecting mass amounts of data to comply with transparency requirements here and abroad. Analyzing the data to identify potential compliance risks is a great way to help fine tune training as well. For example, such an analysis may reveal areas where more in depth training is needed, or it may identify a new audience that needs training on a particular topic. We’ll be interested to hear how training fits into the agenda for this session.

State Disclosure Laws – Preemption, Enforcement and Continued Reporting – Just when we thought the Sunshine Act would clarify state reporting requirements, more changes have arrived in our in box; the latest requiring the reporting of payments to nurse practitioners in a couple of states. This session looks to be a great opportunity to learn the latest in state requirements, and to hear how those states plan to utilize the federal data.

HCP Perspectives on Transparency – Impact and Opportunities Moving Forward – Applicable Manufacturers are not the only ones affected by the Open Payments Program and other transparency initiatives. With little to no voice in the matter, healthcare professionals bear the brunt of having information about them exposed to the public. Understanding HCPs’ transparency concerns is a critical step in training those who interact with HCPs.

The Global Transparency track, which includes a session on Building a Global Transparency Solutions Center, is dedicated to the transparency requirements of the European Federation of Pharmaceutical Industries and Associations (EFPIA). With reporting beginning next year, EFPIA requirements are no doubt a hot topic, but EFPIA’s requirements aren’t the only ones of concern outside the U.S. Understanding the requirements of each code and law and finding commonalities is important when building the systems to manage the data, and building effective training around these requirements. Can training be repurposed from one jurisdiction to another? What “lessons learned” from one location can be applied as more associations and countries implement transparency requirements?

In between conference sessions, we invite you to stop by the PharmaCertify™ booth to discuss your global transparency training challenges in more detail. We’ll be providing demos of our TOV Disclosure Portal™, an exciting new product that gives your company the opportunity to roll out transparency payment data to your partner HCPs for their review and approval before it is submitted to CMS. When disputes are resolved early, HCPs are more confident in the accuracy of the data, and the company/HCP relationship is enhanced. And, if you have to miss this year’s conference, contact Sean Murphy at smurphy@nxlevelsolutions.com.

Stay compliant and we’ll see you in August!

Week in Review, May 6, 2015

NXLevel Compliance Team , , , , , , , , , , , , , , , , , ,

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

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

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

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

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

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

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

Have a great week everyone!

News Week in Review, February 18, 2015

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on Healthcare holds a lively panel session on the Sunshine Act.

Laissez les bons temps rouler, y’all! The end of the Carnival season is here and yesterday was the big send off…Fat Tuesday! Or as you may know it, Mardi Gras. Yes, a time of frolic, frivolity, and according to Turbo Tax, a number of incidents that can affect the filing of your taxes for the next year. Whether you partied until the wee hours in NOLA, or just enjoyed the simple fun of a pancake dinner at home, we hope it was a great celebration. Now it’s time for our regular look back at some of the “celebrated” compliance news of the week, with this edition of the Compliance News in Review.

We start today’s parade with settlement news for several industry companies. Medtronic agreed to pay $2.9 million to settle allegations it violated the False Claims Act. The government alleges the company caused claims to be submitted to Medicare and Medicaid for an investigational procedure. Next, AstraZeneca paid $7.9 million to settle charges it violated the False Claims Act. The company is alleged to have paid kickbacks to PBM Medco in exchange for Nexium’s “solely and exclusively” being maintained on Medco’s formulary. The government claims the kickbacks were provided as prices concessions on other AstraZeneca drugs. Finally, a physician has pled guilty to accepting kickbacks from two pharmaceutical companies in exchange for prescribing the drug, Clozapine. The physician received nearly $600,000 in kickbacks and benefits from IVAX and later, Teva. He also agreed to pay over $3 million to settle a parallel civil case.

The Centers for Medicare & Medicaid Services has been busy tossing beads and doubloons to the industry in the form of advice and consultation. Another Open Payments Q&A session was held just this past week, and in advance of the Q&A session, CMS released several new resources covering system registration and data submissions. The agency has also posted the audio from the January Q&A session.

Speaking of the Q&A session, the February session covered a couple of important topics for industry stakeholders. First, it was announced that a fix would occur over the Valentine’s Day/Presidents Day weekend that should resolve most of the problems that companies are having with submission of the 2013 data. On the downside, attendees were notified that the release of the Validated Physician List has been delayed. CMS is hoping to have the list ready by February 20. Those on the call were reminded that this list is only comprised of physicians for whom a 2013 record was submitted. CMS is scheduling a full day to take stakeholder questions. As soon as a date is nailed down, it will be announced on the Open Payments website and via a listserv email.

It wasn’t exactly cause for great celebration, but a recent briefing held by the National Coalition on Healthcare led to the call for expanded requirements under the Sunshine Act. The panel was comprised of individuals from the government, physician groups and the Pew Charitable Trust. A representative from Senator Grassley’s office explained that ultimate goal of the Sunshine Act was to spur an open discussion between patients and their doctors. The founder of PharmedOut, an organization that advocates against pharmaceutical marketing influence in medicine, took the harshest stance, saying the law wasn’t strict enough. She accused companies of seeking out the family and friends of physicians as an avenue for delivering marketing messages, and expressed grave concern about the industry engaging in disease state awareness. Drug samples were a hot topic. A representative from the AMA says there is a gap in transparency where the provision of samples is concerned and he believes providing samples is “misdirected and unsafe.” The founder of PharmedOut agreed, stating that patients should refuse samples and ask for older drugs that have stood the test of time.

That’s about it for the edition of our weekly look back on all the news fit to blog. As we get closer to spring (albeit, slowly for those of us in the Northeast), and the annual POAs are in the rear view mirror, this is as good as time as any to clean up your commercial compliance training. With transparency extending beyond the U.S., shouldn’t your training do the same? The newest addition to our PharmaCertify™ suite of off-the-shelf eLearning modules, Global Transparency: Reporting HCP and HCO Transfers of Value covers the key provisions of the EFPIA Disclosure Code, French Sunshine Act (Loi Bertrand) and the Medicines Australia Code of Conduct. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more and see a content outline.

Have a great week everyone!

News Week in Review, January 26, 2015

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

Senator Warren looks to use pharmaceutical company penalties to support research at the FDA and NIH, a new report reveals that a significant amount of businesses in China pay bribes, a physician lobbies for a Sunshine Act in Scotland, and a bill is introduced in the House to exclude CME and medical texts from Sunshine reporting.

Comedy, drama and just a dash of controversy thrown in for good measure. No, we’re not referring to this year’s Oscar nominations – although one does have to wonder how The Lego Movie was snubbed for Best Animated Picture – we’re talking about the NFL’s annual supreme slugfest, the Super Bowl. This Sunday, millions will park themselves in front of their television sets to see the Patriots and Seahawks fight it out for the Lombardi Trophy (and of course, the cursory trip to Walt Disney World). If you’re ready for a brief respite from the politics of “Deflate-gate,” we offer all the compliance news fit to blog, with this week’s News in Review.

Starting on offense in our first story is Senator Elizabeth Warren. During a conference hosted by a health advocacy group, the Senator said she intends to introduce legislation that will create a fund to support research at the FDA and NIH. The fund, which Warren referred to as a “swear jar” for the industry, would be financed through fines imposed on large pharmaceutical companies that break the law. Fines will only be imposed on companies with at least one blockbuster drug, and would equal 1% of a company’s total profits for each blockbuster drug it sells.

PhRMA quickly lined up on the other side of the ball to oppose the issue. The organization pointed out that the industry spends billions of dollars on research each year and is responsible for 20% of all funding of domestic research. The statement went on to say the work of the NIH is important, but to “siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society.” Those consequences would ultimately include fewer medicines and loss of jobs.

If you think Deflate-gate is controversial, it doesn’t compare to a recent report that found 35% of businesses in China pay bribes in order to do business in the country. One CEO participating in the research called bribery the “unspoken rule.” The problem is more common in foreign companies than those based on the mainland, and the real estate and construction sectors have the highest instances of bribery. The vast majority of research participants describe bribery in China as a “plague,” and just over 60% of the participants would like to see action taken to stave off the problem. Unfortunately, a third of participants are not optimistic about that happening.

It’s third down and goal for a transparency initiative in Scotland. A physician will have his petition for a Sunshine Act in Scotland heard by the Scottish Parliament for the third time. The physician is petitioning the government to create a law that establishes a searchable database of payments from pharmaceutical companies to National Health Service healthcare workers.

We’re back in the transparency replay booth here in the U.S. as well. A bipartisan bill was introduced in the House of Representatives to exclude the value of CME and medical texts from reporting, under the Sunshine Act. This is the second go around for the bill in the House.

Well, that’s it for this Super edition of the Compliance News in Review. Whether you’re rooting for the Seahawks or Patriots, or just a great halftime show by Katy Perry, enjoy the game and we’ll see you right back here next week. Have a great week everyone!

Week in Review, September 17, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

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, August 27, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , , ,

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!

 

News Week in Review, July 29, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

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, June 24, 2014

NXLevel Compliance Team , , , , , , , , , , , , , , , , , ,

New social media guidance from the FDA has arrived, a new survey points to the need for reps to be comfortable with the science of what they sell, and PhRMA asks CMS for an extension of the data submission deadline.

We have officially, or astronomically anyway, reached summer! The Summer Solstice occurred over the weekend, giving those of us who live in the northern hemisphere the “longest” day of the year. We hope you found a fun and worthwhile way to enjoyed those extra, precious minutes of daylight. While we may slowly be losing daylight from now until the Winter Solstice in December, that doesn’t the party needs to end. We’ll keep the celebration going as we take a look back at the compliance news of the week, with the News in Review.

Two new social media guidance documents from the FDA have finally seen the light of day. One covers the topic of correcting misinformation posted by third parties on the Internet and social media. The document discusses the situations in which the guidance applies; the information that should be included in a response to misinformation; and the type of communication that is outside the scope of the guidance. The other document covers the presentation of risk and benefit information on social media platforms that restrict the number of character spaces. The guidance features examples of how companies can include risk and benefit information in these platforms.

While the limited character guidance was certainly welcomed, companies still need to proceed cautiously with platforms such as Twitter. The guidance does allow for the use of URL shortening services, as well as the use of common abbreviations to help address the character limitations. However, just providing a link to risk information, or posting a follow-up Tweet, is not sufficient for communicating risk.

A new season has dawned for pharmaceutical sales reps according to a recent survey of healthcare company leaders. More than half of the respondents said selling isn’t the most important skill for reps. Today’s products require sales reps be able to hold in-depth scientific conversations with doctors. Evolving technology was also referenced as being a key factor in the changing role of a sales rep.

A former president of the American Medical Association would like to see physicians and industry companies spending time together in the Sunshine. At a recent conference, former AMA president, Jeremy Lazarus, commented that manufacturers need to work with physicians to develop a mutually beneficial relationship when dealing with the requirements of the Sunshine Act. He said many physicians are still unaware of Sunshine, even though information about their relationships with industry companies will soon be publicly accessible.

PhRMA would like to see the Sunshine “extended.” Last week PhRMA sent a letter to CMS suggesting that the June 30 Phase 2 data submission deadline be extended. In the letter, PhRMA said its members are reporting technical problems with the registration process in Open Payments. Companies have also encountered numerous problems when uploading data. The problems are particularly troublesome for foreign entities, and those entities are having issues getting help because the CMS helpdesk does not accommodate European or Asian time zones. PhRMA would like CMS to extend the deadline 30 days once the agency confirms that the glitches have been corrected and the system is operating correctly.

The release of the latest social media guidance by the FDA is a timely reminder that promotional statements must meet certain requirements, regardless of the communication platform. That’s why we are updating the PharmaCertify™ Good Promotional Practices module to include the new information. The module is targeted to sales and marketing staff and topics include gifts, meals and entertainment; promotional statements; advisory boards; and the handling off-label inquiries.

Have a great week everyone!