Life Science Compliance Update

April 28, 2017

ExL Events to Host the 8th Aggregate Spend and Sunshine Act Conference

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Unlock the Value of Transparent and Efficient Data Reporting to Improve the Operation of Your Organization

ExL Events will host the 8th Aggregate Spend and Sunshine Act Conference this June 15-16 at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA.

Progressive leaders from pharmaceutical, biotechnology and medical device companies will convene for two days to discuss the value of transparency reporting and exchange tools used to translate aggregate spend data into business improvements that enhance daily efficiency. View the complete agenda and faculty list here.

This annual conference attracts delegates globally. Participants will include representatives from Pfizer, Viscadia, Alkermes, Qiagen, Sun Pharma, Foundation Medicine, Bayer Healthcare, Chiesi, Draeger Medical, Horizon Pharma, Concur, Regeneron Pharmaceuticals and Medtronic.  

Featured speakers include:

  • Michael O’Connor, Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS, INC.
  • Gretchen Reyes Cseplo, Compliance Officer, US, Canada and Global Compliance Operations, CONVATEC
  • Avi Spira, Vice President and Chief Compliance Officer, CANTEL MEDICAL CORP.
  • Ben Yao, Director, Transparency, ASTELLAS
  • Amie Phillips Pablo, Associate Director, Government Reporting, NOVO NORDISK INC.

Conference sponsors and supporting partners include: Concur, MedPro Systems, QuintilesIMS and Alanda Software.

Register now to save $200 off the standard registration rate — early bird pricing expires April 28. Please mention priority code C882PMLSCU when signing up.

ABOUT EXL EVENTS
ExL Events, a division of Questex, LLC, is the industry leader in developing innovative, educational conferences that serve the pharmaceutical and allied healthcare communities in the United States, Europe, Latin America and additional markets. Its experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality events designed to exceed the dynamic informational and networking needs of audiences. ExL Events conference platforms facilitate the exchange of critical information between industry executives and suppliers to support their scientific and commercial goals. www.exlevents.com

CONTACT
For business development and sponsorship opportunities, please contact Alexander Siegel at 917-242-3893 or asiegel@exlevents.com.

For general information, please contact Tyler Lobo, Conference Production Director, at 917-242-3899 or tlobo@exlevents.com. 

April 11, 2017

Open Payments Starts Review and Dispute…On A Saturday

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With the close of Open Payments submission just behind us, the Centers for Medicare & Medicaid Services (CMS) plans to publish the Open Payments Program Year 2016 data and updates to the 2013, 2014, and 2015 program years on June 30, 2017.

As such, the review and dispute period for the Program Year 2016 Open Payments data publication begins on Saturday, April 1, 2017 and will last until Monday, May 15, 2017. Physicians and teaching hospitals must initiate their disputes during this 45-day review period in order for any disputes to be addressed before the June 30th publication.

Physician and teaching hospital review of the data is voluntary, but strongly encouraged by CMS. While the opportunity for physicians and teaching hospitals to dispute any data associated with them expires at the end of the calendar year in which the record is published, the disputes must be addressed during the 45-day review and dispute period, ending on May 15th, in order to be reflected in the June 30th publication. 

To those who have never registered in the Open Payments system before, you will need to create an account. To do so, make sure you have your National Provider Identifier (NPI) number, Drug Enforcement Agency (DEA) number, and State License Number (SLN). Initial registration is a two-step process and should take approximately 30 minutes: first, you will need to register in the CMS Enterprise Identity Management System (EIDM) and from there, you can register in the Open Payments system.

Physicians and teaching hospitals who registered last year do not need to reregister in the EIDM or the Open Payments system. If the account has been accessed within the last 60 days, go to the CMS Enterprise Portal, log in using your user ID and password, and navigate to the Open Payments system home page.

However, the EIDM locks accounts if there is no activity for 60 days or more. To unlock an account, go to the CMS Enterprise Portal, enter your user ID and correctly answer all challenge questions; you’ll then be prompted to enter a new password. The EIDM also deactivates accounts if there is no activity for 180 days or more. To reinstate an account that has been deactivated, contact the Open Payments Help Desk.

CMS Is Offering a Teleconference on the Review and Dispute Process

Join the Centers for Medicare & Medicaid Services (CMS) on April 13, 2017 for an informative session on the Open Payments Review and Dispute process.

This National Provider Call will provide physicians and teaching hospitals an opportunity to learn about the review and dispute process, including how to access the Open Payments system to review the accuracy of the data submitted before it is published on the CMS website.

A question and answer session will follow the presentation. Topics covered will include: overview of the Open Payments Program; Program Timeline; Registration Process; and critical deadlines for physicians and teaching hospitals. 

March 31, 2017

Access Problems Persist with Open Payments…

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With less than two days left to submit and attest to data for the June 30, 2017, publication, manufacturers and group purchasing organizations (GPOs) continued to have problems with the CMS Open Payments Portal. (Today is the deadline – we received notice that the site was down late Wednesday night).

Seen below is a screenshot we were sent from one of our sources, which notes that the “CMS Enterprise Portal is currently not available due to an outage. We apologize for any inconvenience. Please try back later.”

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CMS has sent several “reminder” emails this week about the upcoming deadline, but nothing about the consistent problems we have heard from several sources. CMS helpfully reminds applicable manufacturers and applicable GPOs that they can “complete the data submission and attestation activities by logging into the Open Payments system through the EIDM Portal, but leaves off any information for help other than “Contact the Help Desk.”

Our question to CMS is, how do they expect companies to fully comply with these onerous requirements when they cannot even get the site up and running well enough for manufacturers and GPOs to input their information in the most efficient way possible?

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