Too Many Pharma Associations, Too Little Disclosure?

In our previous post on Dr. Klaus Geltsetzer’s webinar presentation, how to “Determine the Relationships of Different Global Disclosure Requirements” we described how Germany’s consent rates tell an interesting story, depending on how they’re calculated.

We’re resuming the debate on Germany’s position in the pharmaceutical transparency space. This time, we discuss industry-led, private sector synergy.

Or lack thereof.

As we learnt, thanks to Dr. Klaus Geltsetzer, there are ‘several’ Pharma associations in Europe. Prominent amongst these are:

  • vfa (ca. 150 members)
  • BPI (ca. 240 members)
  • BAH (> 450 members)
  • Pro generica (16 members)

That’s an impressive number for one country. It also shows a determined, national effort towards improving pharmaceutical disclosure.

Or does it?

As Dr. Geltsetzer mentioned, there are over 300 pharmaceutical companies in Germany. And these associations will find ‘overlapping’ memberships. To put it another way, although the sum total of memberships is 856, the real number is far less. Possibly less than 50%, accounting for double memberships.

A closer look tells us something else. Pronunciation is just one of many things confusing about these associations. Slightly more puzzling is their collective purpose.

BPI and vfa have founded two independent national organizations to promote ethics and transparency:  FSA e.V. and AKG e.V.

But how does the ethics code—introduced by FSA e.V and AKG e.V.– apply? More significantly, who does it apply to?

The Disclosure Code is not universally applicable. Members of vfa, Germany’s representative association in EFPIA, are obliged to adhere. It is also mandatory for the fifty or so members of the FSA. What about the bigger associations, BPI and BAH?

We cannot say. What we can tell you, that one of the two bodies, who developed the disclosure code, AKG, has not made it mandatory for its members to disclose. That is, over one hundred pharmaceutical companies need not submit their spend reports. Equally disconcerting is the status of non-affiliated pharmaceuticals in Germany.

The publishing paradox vis-à-vis pharmaceutical associations in Germany suggests that appearing transparent is a greater priority than achieving transparency. At least for now.

The good news, however, is that the Transparency journey has taken an ambitious stride since then. In our next post, we’ll be describing it.

 

Pharma Disclosure’s Surprisingly Powerful Ally In Germany

Synergy between pharma associations may never materialize. It may even backfire. We will be elaborating on this in an upcoming post, with the real-life case of pharma disclosure in Germany.

Today we discuss how public interest has surfaced as a surprisingly powerful ally in the pharma transparency movement.  Before exploring the ‘whats’ and ‘hows’, we would like to talk a little about why ordinary citizens would take interest in something like pharmaceutical spend.

Public Interest

An obvious answer, public interest. Citizens have a right to know the composition of public and private healthcare. They need to know the components of decisions related to treatment options available to them. In this, the importance of physician-pharma relationships can be illustrated by this example:

Despite the “Welfare State” status governing Europe’s largest economies, the doctor-patient relationship is still transactional, with an uneven power balance.

The doctor, using his/her credibility as the only tool, convinces patients to undergo treatment, even if it is risky and painful. The patient—who is not, and cannot—be as informed about the treatment, needs to trust the doctor.  The cost of such a procedure gone wrong—and left unreported—will not cost the doctor much. He/she may simply move on to other cases. But what about the patient? Even with disability, possibility of death, or some lasting deformity, how will he/she—with a superficial knowledge of medicine—prove the doctor’s oversight without the help of—another doctor?

This is just one scenario. Even if a monetary exchange is not involved, a doctor’s conflict of interest can exist, and may exhibit itself by:

  • Persuading patients to undergo high-risk, experimental procedures, for the sake of shortening clinical study cycles.
  • Prescribing expensive, less effective medicines in the presence of less-costly alternatives
  • Prolonging patient treatment in exchange of favors from sales reps (number of scripts Vs physician spend), or worse, prescribing drugs the patient does not need.

These—and other– scenarios have been true horror stories for patients around the world at some point or the other.

Spend data publication tilts an uneven power balance slightly in favor of the patient. By providing visibility into physician spend data, pharma disclosure allows them to:

  • Make informed choices about their health and professionals treating them
  • Know the route for self-advocacy and have the freedom to switch physicians/treatment with a fair case, or raise public outcry if needed.

What has your experience with public interest pharma disclosure been like? Let us know.

Seven Quick Tips For Starting Your Own Analytics Program

In one of our most effective webinars this year, Wendy Derosa and Bryan Timer, both Compliance professionals at Merck USA, had useful advice for small and mid-sized pharmaceutical companies just starting out in the analytics space. Here’s what they had to say.

  1. Start Small: Before the emigration to a sophisticated analytics platform, it helps to start small first. Even spreadsheet software can help you capture errors easily with filtering tools; the sorting function and so on. It’s a little harder to capture duplicates, given the number of transactions per month, and also the fact that similar HCP names may overlap and present a confusing story to anyone doing the process manually. Nonetheless, starting small is better than not starting a compliance program at all.
  2. Year-round Review: CMS Stress tends to build up in the first quarter each year. Take advantage of the rest of the year, even if the reporting cycle (for USA) is between December and March. This will give you enough legroom to explore the nature of payments, identify and remedy erroneous processes and so on. During this review, focusing on extraordinarily high and low spend amounts, identifying missing addresses, and approaching data via ‘batches’ or ‘clusters’ are helpful directions to follow. A compliance analyst may also—resources permitting—probe via ‘people queries’ by ‘zoning in’ on specific HCPs, or following activity for a specific sales rep.
  3. Document everything: Old hands in the pharma/compliance transparency space are well-acquainted with this one. Nothing, as newer compliance professionals will learn, is too small or too immaterial to ignore. Everything must be documented, it may help justify a cost, or save you the reputational risk and cost involved with a CMP. In fact, if you’re following in the footsteps of Merck’s program, it would be advisable to create an ‘evidence’ folder to store such data.
  4. Emphasize Process: Good analytics software makes the compliance team fairly independent. It also substantially reduces training and human-error costs. For organizations who are yet to reach scale to justify their own analytics solution, emphasizing process is the way to go. Have a visible, methodical workflow on what you’re doing month-on-month (MoM), so that in the absence of one resource, work can continue uninterrupted. This will also help you when an external stakeholder—such as an auditor—needs a walkthrough.
  5. Be Sensitive To Perception: Public investigators and the media are unaware of the inner workings of your pharmaceutical company. They do not know your company’s history as well as you do. They will only learn of strategic decisions when you decide to announce them. It is also, therefore, your responsibility to be careful about the message your data gives out. Be sensitive to the perception your data creates, and be prepared to support it with answers.
  6. Business Has To Be With You On The Table: Get internal customer buy-in. The earlier, the better. They need to understand why this is important. In the pressure to meet targets, business often forgets that ethics is everyone’s responsibility. Threshold violations are everyone’s problem. Compliance isn’t a ‘necessary evil’ of pharma spend, but a useful process which helps everyone do his or her job better.
  7. Recruiting The Right Talent Is Key: Software will make visibility and analysis easier, but your job, as a compliance professional, does not end there. Hiring and then training the right talent is equally –if not more— important to keep the process on track. Quantitative and analytical skills are important, of course. A candidate with a passion for research (qualitative data included), data engineering and software development—will be a big plus. But the secret ingredient towards building a strong compliance team is seeking people passionate about transparency. When you hire people for the right values, the right skills follow on their own.

Compliance Analytics Session by M. Ovais at Global Transparency Reporting Congress

London, 5th April 2017:  Mohammad Ovais, founder/CEO, qordata was one of the keynote speakers at the 7th Annual Global Transparency Reporting Congress in UK. Titled, “Best Practices For Compliance Analytics,” the session provided guidelines for optimizing internal data for Transparency/Compliance in the global pharmaceutical industry.

Reiterating the importance of data scrutiny, M. Ovais described how pharmaceuticals are often challenged in this area by system limitations, and how they need to enforce compliance requirements by prioritizing it as a practice throughout the reporting cycle. “With the focus on submission and data collection, this is easily missed. You have to consciously allocate time in the process to do this necessary step.”

Press Release--UK ConferenceAnalytics solutions may vary from simple to sophisticated. However, the minimum requirement each system must meet is the ability to visualize aggregate spend data and highlight outlier spend. These are basic components for high-level decisions. The ability to identify relevant spend outliers is another best practice and will include categories like distributor sales, high-risk vendors, missing and unusual TOVs.

Granting spend data accessibility to sales staff is another practice which varies by scale. Good systems allow sales teams to directly review and sign off on such data.  Benchmarking and the ability to derive KCIs from internal metrics are two critical responsibilities compliance and transparency professionals within the pharmaceutical space need to undertake—if they are not doing so already.

Each year, subject matter experts from the pharmaceutical industry share their findings at the Global Transparency Reporting Congress. As a foremost provider of SaaS solutions for spend analytics, qordata has been a regular participant at this event.

For media queries, please contact:

Mr. Zafar Ahmed, Head of Marketing & Sales, qordata
zafar.ahmed@qordata.com
+1 (888)-906-38282  |  +1 (832)-220-3479
www.qordata.com

About  qordata qordata is an organization providing Data Management and Business Intelligence Solutions to clients in the Life Sciences Industry. It employs Big Data, analytics and integration and MDM to facilitate clients in decision making related to Compliance and Transparency.

Mohammad Ovais A Keynote Speaker At The 5th Annual Compliance & Transparency Conference

Zurich, Switzerland: Mohammad Ovais, CEO and Founder of qordata, was one of the keynote speakers at the 5th Annual Corporate Compliance & Transparency Conference in the Pharmaceutical Industry.

In his address, Mr. Ovais described how qordata, one of the foremost providers of a SaaS Solution for Pharmaceutical Compliance, Business Intelligence and HCP/HCO Engagement, has identified and resolved transparency issues in the Pharmaceutical Industry.

Assisting Compliance Professionals internally monitor Pharmaceutical and Device Spend Issues has been the starting point for more sophisticated solutions from qordata. These solutions go a step further by developing customized data models, employing analytics and representing them in sophisticated, visually appealing dashboards. Users have the flexibility of generating customized spend reports by conducting multi-party, drill-down and drill-up analysis.

These reports assist Ethics and Compliance Committees, Transparency Boards and Internal Audit decision-makers in implementing ethical best-practices and asserting decisions related to the same.

As Mohammad Ovais recounted in his address, Pharmaceutical Clients often spoke of the disputes arising in data due to no or revoked Physician Consent in Europe. This is how HCPEngage, a solution which respected physician privacy while complying with the EU Transparency Directive, was introduced by qordata.

Mr. Ovais addressed questions on how solutions by qordata reflect the specific regional requirements of each market it operates in—primarily North America, EFPIA member states, extending to other clients in Europe. Challenges posed by new EU Data Protection Rules have also been built into qordata’s product offering, and were highlighted during the conference.

The Corporate Compliance & Transparency Conference in the Pharmaceutical Industry, which concluded on 23rd February 2017, draws some of the world’s most important decision makers in the Life Sciences Industry each year.

For Media Queries, please contact:

Mr. Zafar Ahmed, Head of Marketing, qordata
zafar.ahmed@qordata.com
+1 (888)-906-38282  |  +1 (832)-220-3479
www.qordata.com   

About qordata: qordata is an organization providing Data Management and Business Intelligence Solutions to clients in the Life Sciences Industry. It employs Big Data, analytics and integration and MDM to facilitate clients in decision making related to Compliance and Transparency.

EFPIA Disclosure & Consent Management

From our well-founded experience in EFPIA Analytics, we know Round I of the EFPIA Transparency Directive has been a confusing experience even for the best. In the slides presented below, you will get to learn about:

– Upcoming changes in consent management regulation

– Expectations of consent rates in the next round of disclosures

– Practical experiences in implementing a consent management tool

– The biggest legal risks in consent management

 

The Risks of Open Payments – Validate Spend Reports With Data Analytics Prior To Submission

With the next filing period for spend data under the Sunshine Act coming up, pharma companies are going to be responsible for making sure that the data they submit to CMS is accurate, complete and free of data anomalies. In the slides below, you will get to learn about the implications of public availability of Open Payments data, the ways in which it can be used by government authorities to initiate enforcement actions, and most importantly, how you can evaluate your spend before CMS submission through data analytics to ensure it doesn’t contain questionable transactions.

 

A Brief Look Into EFPIA Disclosure Code & HCP Consent Management

 

Pharmaceutical companies across Europe disclosed their financial interactions with HCP’s on June 30th 2016 in line with the guiding principles of the EFPIA disclosure code. Privacy laws in certain EU member countries deem it necessary for pharma companies to acquire consent from HCPs for individual disclosure. In the knowledge-packed presentation below, you will get to learn about various elements related to:

– Transparency
– Compliance
– Anti-corruption requirements in the EU
– Practices and strategies of pharma companies in the EU for the management of transparency and disclosure reporting
– Legal and regulatory aspects of consent management
– Best practices for HCP consent management

 

The Ways In Which Data Analytics Can Help Reduce Compliance Risk

With the endless amounts of publicly available Open Payments data published by CMS and a myriad of analytical methods and toolsets available these days, what should a compliance officer do to ensure best practices for sing data analytics?

In the presentation below, Benjamin Yao of Astellas Pharmaceuticals, Kelly Tope of Zimmer Bioment & Mohammad Ovais of qordata cover a compliance officer’s perspective on the utilization of data analytics to improve on existing monitoring and compliance programs. By going through the presentation, you will learn about:

– Top three methods that compliance officers can use for effective monitoring of their spend programs
– Finding non-compliant payments
– Advanced monitoring using Open Payments data
– General compliance auditing
– Identifying outliers on the basis of benchmarks and business rules
– Competitor bench marking and analysis

 

A Look Into Two Years of Open Payments Data and its Media Coverage

With three years’ worth of Open Payments data made publicly available by CMS, trial lawyers are putting in their best to mine all that transparency data and pull out questionable transactions to bring new health care fraud cases to light. Apart from that, the media is also working hard to highlight these cases, which deems it necessary for pharma companies to be all the more careful when documenting their spend data.

In this interesting presentation, Thomas Sullivan, Publisher, Life Science Compliance Update, provides a detailed review of the 2014-2015 Open Payments Data, an evaluation of persecutions and an extensive assessment of the congressional actions on Open Payments. It moves on to providing details about the ways in which Open Payments data is being evaluated by the media along with other tied in spend reports to find and highlight data anomalies.

 

Consent Management in European Union: Things You Should & Shouldn't Do

Data Privacy laws in the EU dictate that it is vital for pharma companies to acquire HCP consent prior to publishing individual physician data. What this means is that pharma companies must gain consent from all the physicians and teaching hospitals that they perform transactions with so as to publish their data under the EFPIA Transparency Directive.

In the presentation given below, Maite V., a legal expert on data privacy, and a data management expert on physician consent has shared practical solutions, options and best practice guidance with regards to consent management in the EU. Moving forwards, Ned Mumtaz, Practice Leader Life Science at qordata has also provided information about the regulations for physician consent, data capturing and/or publishing reports. Chief Compliance Officers, Directors of Compliance, Managers of compliance and any other interested parties are encouraged to go through the presentation.

 

A Look Into What The EFPIA Physician Spend Numbers May Be Telling Us!

Ever since the first public disclosure was made under the EFPIA transparency directive on June 30th, 2016, the press had raised countless questions pertaining to the rates of consent received by pharma companies from physicians. Here’s a presentation by qordata’s Practice Leader Life Science, Ned Mumtaz, in which he presents an extensive overview of the EFPIA transparency directive and physician spend numbers. The presentation then moves to providing information about the countries that require and/or do not require consent. Here’s what you will learn about when you go through the presentation:

– Practices and strategies of pharma companies in EU countries to manage disclosure reporting and transparency

– Disclosed physician spend numbers from various member countries

– Rate of consent in various EU member countries

– Details of disclosed physician spend

– Initiatives taken by pharma companies to increase the rate of consent

 

Risks of Open Payments and Medicare Part D Data – Where Did Insys Go Wrong?

Insys Therapeutics Inc. was sued in the state of Arizona for providing illegal kickbacks to physicians for prescribing Insys’ drug Subsys – and this was done using the publicly available Open Payments and Medicare Part D data. The manufacturer settled this class action suit for $6.2 million earlier this year, making this the first case of a drug company getting accused of kickbacks by investigators using publicly available spend and prescription data.

In this presentation by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, qordata review the cases against Insys Therapeutics and look at the data used as part of the allegations. The presentation will further provide information on the ways in which compliance teams can take a proactive approach to analyze publicly available data as a means of avoiding the risks of kickback violations.

 

Implementation of the EFPIA Disclosure Code & Analysis of Spend Data

Pharma companies across Europe disclosed information about their financial interactions with HCPs during 2015 on the 30th of June, 2016 under the EFPIA Transparency Directive. In this presentation, Dario Ghoddousi, VP Product Management, Compliance Solutions at QuintilesIMS and Ned Mumtaz, qordata’s Practice Leader Life Science, provide an overview of the implementation of the EFPIA disclosure code, the discrepancies in reporting requirements of member countries and transparency implementation challenges.

Apart from that, the presentation covers details of reported EFPIA physician spend numbers, consent rates and the initiatives being taken by companies to increase the rate of consent.

 

qordata Adds 2015 Open Payments Data to its Open Payments Analytics Software

qordata announces the addition of the latest 2015 Open Payments data that was made available by CMS to its software. Headquartered in Princeton, New Jersey, qordata provides analytics software to pharmaceutical companies to help them get more out of their open payments data and to ensure that it complies with all data submission requirements set by the CMS.  The company has developed the Open Payment Analytics platform that serves over 40 leading customers in the Pharma & Life Sciences industry. With the 2013 and 2014 Open Payments data already in the system, qordata has now added the 2015 spend data of pharma manufacturers into its system on the 5th of July, 2016.

With the 2015 data and new dashboards, pharmaceutical manufacturers and GPO’s will have the ability to determine FMV, spot outliers, detect off label & transparency reporting errors, analyze spend data and have real analytics in place, identify spend data discrepancies and mitigate FCA and anti-kickback statute.

According to Zafar Ahmed, Head of Marketing at qordata, “With the 2015 data now available, compliance departments can now empower the entire organization with a live interactive dashboard of their 2015 spend data and give a retrospective analysis of their data.”

The new data comes with new and revamped dashboards to add value to compliance and marketing functions. These include:

[mk_custom_list style=”e1a5″ icon_color=”#622a6a” margin_bottom=”30″ align=”none”]

  • Executive Summary
  • Spend by Physician
  • Spend by Hospital
  • Spend by Type & Period
  • Spend by Geography
  • Spend Outliers
  • Company Spend Summary

[/mk_custom_list]

About qordata: qordata software solutions to pharmaceutical companies to help them get more out of their open payments data and to ensure that it complies with all data submission requirements set by the CMS. qordata’s core competencies and expertise lie in data analytics, integration, master data management and big data.

Official Announcement To Launch New Start-Up “qordata”

We are pleased to announce the launch of “qordata,” a data management and business intelligence startup that provides software and consulting solutions to Pharmaceutical and Life science corporations in the areas of compliance, marketing and commercial operations. qordata will inherit Streebo’s Open Payment Analytics platform that serves over forty customers in the pharma and medical devices industry.

qordata was previously part of Streebo which has now spun-off its Pharmaceutical Software and Consulting Solutions practice to qordata with independent management teams, each equipped with the resources, strategic autonomy and financial flexibility.

qordata will be led by CEO Mohammad Ovais and will be headquartered in Princeton, New Jersey. The main driving force behind this move is innovation and commitment to become leaders in data management & business intelligence sector for Pharmaceutical and Life science corporations. qordata’s core strategy will focus on strengthening its pharmaceutical and life science industry portfolio.

“We expect to work closely with pharma, life sciences, medical device and diagnostic companies to provide software and solutions that solve critical business problems. With a targeted focus we expect to accelerate innovation and become the go-to partner for pharma companies on data and information management,” said Mohammad Ovais, CEO, qordata.

qordata’s mission is to become an innovation factory that produces technology solutions to have a significant and meaningful impact in pharma, life science, medical device and diagnostic industries.

qordata product suite consists of qordata insights which is spend analytics platform, consent management for HCP consent and Physi-engage for HCP dispute management.  We have taken cloud, database, visual analytical tools and tied it to a set of publicly available data to create something that has not existed in the industry yet.

We would really appreciate your continued supports to our activities and looking forward to great progress into the future. Special thanks to everyone who is a part of qordata.

For any questions, suggestions, feedback or comments, please e-mail info@qordata.com

About qordata: qordata is a data management and business intelligence startup that provides software and consulting solutions to Pharmaceutical and Life science corporations. qordata’s core competencies and expertise are in data analytics, integration, master data management and big data. Open Payments Analytics will be rebranded as qordata insights.