Life Science Compliance Update

May 04, 2016

CBI Forums on Transparency & Aggregate Spend

The Annual Forums on Transparency and Aggregate Spend are coming up. The 7th Annual West Coast Forum on Transparency & Aggregate Spend will be held May 18-19, 2016 at the Westin in San Diego, CA. The 10th Annual Forum on Transparency & Aggregate Spend will be held August 15-17, 2016, at the Ritz-Carlton in Washington, D.C.

West Coast Forum on Transparency & Aggregate Spend

This annual forum is the only West Coast Forum that is dedicated to the strategies and tactics to accelerate the effectiveness of organization transparency initiatives. This year's forum will feature presentations on: managing the process of changing your vendor, understanding how to capture spend in foreign countries after your firm expands or acquires, proving ROI on your transparency reporting initiative by optimizing systems and processes.

This year's schedule includes several general sessions on a variety of topics. The first session in the main conference focuses on how to improve your process for data remediation, and is presented by Elizabeth Schwartz, the Director of U.S. External Reporting and Transparency, Global Operations, at Johnson & Johnson Health Care Compliance and Privacy.

Day Two starts out with concurrent working groups, each on different topics, including: identifying high-risk areas and impactful competitor activity using transparency data, overcoming the pitfalls involved in working with third-parties, and identifying opportunities to improve communications with physicians and teaching hospitals. The conference ends with a keynote speech on how to ensure transparency of fair market value and a live polling benchmarking survey.

Attendees can save $300* on registration fees if they register by May 17, 2016, and use promo code AGGWPL.

East Coast Forum on Transparency & Aggregate Spend

This annual forum features solution-oriented sessions, working groups, and topic intensives on topics such as: how to use data analytics to assess compliance risk; how to enhance systems for data remediation and validation; how an Open Payments audit would look, including FCPA issues and off-label indications; and some of the differences between EFPIA and U.S. transparency regulations.

The forum starts on Monday, August 15, 2016, with two pre-conference workshops: one on transparency reporting for medical device, supplies, dental manufacturers and distributors; and the other focusing on the impact of the EFPIA Disclosure Code and Open Payments reporting on U.S. and European meetings and event management.

The forum continues the next day with a CMS keynote address on Open Payments and a panel discussion on understanding trends in recent enforcement targets. Day two closes out with a panel discussion on how to structure and initiate a global transparency compliance program and a keynote speech presenting a progress report of the implementation of EFPIA disclosure code and June 2016 publication results.

Day three rounds out the forum, where the morning session offers ten concurrent sessions (working groups and topic intensives) for attendees, who select five to attend. The topics covered include: transparency disclosure guidelines around the world; how to implement metrics and monitor to ensure compliance; how to ensure the accuracy and completeness of data; and how to make 2017 a more user-friendly experience when reporting 2016 Open Payments data.

Attendees can save $400* on registration fees if they register by May 17, 2016, and use promo code AGGPOL.

*Discount expires 5/17/2016; applies to standard rates only and may not be combined with other offers or applied to an existing registration.

April 18, 2016

District of Columbia Makes Changes Transparency Law to Align with Open Payments

Late last week with only a photo attachment, the District of Columbia Department of Health announced to the pharmaceutical industry that the District is changing its gift reporting requirements to meet the requirements with the new Open Payments reporting.

Chapter Eighteen of the District of Columbia Municipal Regulations requires manufacturers and labelers of prescription drugs dispensed in the District who engage in marketing in D.C. to report to the Department of Health their costs for pharmaceutical drug marketing in the District. Each manufacturer or labeler is required to report their annual prescription drug marketing costs in a report filed with the Department of Health on or before July 1 of each year.

This year, the aforementioned changes will be reflected in the Nature of Payment, Form of Payment, and Primary Purpose sections. The categories will have to align with Open Payments categories. Some responses will now be limited to the updated set of values.

While payments made to physicians or teaching hospitals must be reported to the United States Department of Health and Human Services (HHS), companies are not required to report this information to the District of Columbia. However, payments made to recipients other than physicians and teaching hospitals must be reported to the District of Columbia. Reporting requirements for aggregate and advertising expenses remain unchanged.

The D.C. Department of Health recommends that companies who have filed reports in previous years use the Microsoft Excel file published online, as it will reflect changes and updates in the law. Complete instructions for filling out the forms are found in the PDF document, as well as on the fifth tab of worksheet of the Excel document.

The Company Information, Gift Expenses, Advertising Expenses, and Aggregate Cost worksheets should be filled out electronically according to the instructions, and submitted in Excel format to dc.accessrx@dc.gov. The Company Information worksheet should also be printed and sent to the D.C. Department of Health, along with a $5,000 filing fee check made payable to "D.C. Treasurer."

This change was supposed to take place in 2013 when the Physician Payment Sunshine Act preempted state reporting. The District of Columbia is a little late to this change.

 

April 13, 2016

UK’s Version of EFPIA Disclosure: Bred with the Sunshine Act in Mind

Recently, we wrote about the transparency and disclosure changes coming to Europe, and promised a more in-depth view of the United Kingdom system. As we mentioned, beginning June 30, 2016, patients will be able to find out if their physician, pharmacist, or other healthcare professional has received payments from a pharmaceutical company. The payments include payments for attending a medical event to acting as an advisor to a company, and will be listed on a publicly searchable database, Disclosure UK. The database will be hosted by the Association of British Pharmaceutical Industry (ABPI).

While this move was prompted by EFPIA (the European Federation of Pharmaceutical Industries and Associations), thirty-three countries in Europe will apply the transparency goals and recommendations in different ways. Some countries are opting for a central platform database similar to the UK database, and others will allow for payment disclosures to be made on company's own websites. Some countries (i.e., France, Slovakia, Greece, Romania) have even passed legislation to make disclosures of payments to healthcare professionals mandatory.

ABPI believes that while the EFPIA requirement only mandates that payment information be available on the relevant Member Company's website, using a central database will make it easier for interested parties to access the information and to compare data.

In the United Kingdom, disclosures will be made by companies who pay the healthcare companies (similar to the requirements under the United States Physician Payment Sunshine Act), but payments may only be included in the public database if the healthcare professional gives their consent. Such data protection rules may help to protect physicians from some of the untoward effects we have seem stem from public disclosure of physician and pharma ties in the United States.

United Kingdom Health Secretary Jeremy Hunt, however, seems to be a fan of the Sunshine Act, because he is introducing a "sunshine rule," specific to dealings with National Health Service (NHS) personnel. If NHS staff are found to be abusing their position by taking extravagant gifts or hospitality and lobbying for unneeded or overly expensive drugs, negative consequences follow, ranging from disciplinary action to dismissal to imprisonment.

How Will the ABPI System Work?

As a broad brush overview, the system will first rely on companies to collect details of any relevant payments made to Health care providers (HCPs) or health care organizations (HCOs) and collate them into a standard template, which will be modeled after the EFPIA template. Then, the template will be uploaded through a secure system. Payment data from all companies will be consolidated and reconciled in a central location, with unique identifiers being added to all HCPs and HCOs. A third party provider will manage this aspect, ensuring the data is "clean, complete and up-to-date." The third party provider will then also maintain the centrally-hosted database where the information can be found.

ABPI will provide materials and training for Member Companies as to how the system will work as they begin to gather data. HCPs whose data will be disclosed will be personally and individually contacted throughout 2016, with notification of what data will be disclosed and when.

The very first disclosure will be available on the ABPI system by July 1, 2016, covering payments made through the entire year of 2015.

If you are an ABPI member company and you have questions, or would like more information, you may email disclosure@abpi.org.uk. ABPI members may also email disclosure@abpi.org.uk to be added to the Disclosure Network distribution list, where they will receive detailed operational updates on the project.

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