Polaris Insights Blog

Yesterday's CMS Open Payments Review & Dispute Resolution Process Call

Posted by Alice Dong

Jul 23, 2014 11:50:38 AM

Updates from Yesterday's National Provider Call on the CMS Open Payments Review & Dispute Resolution Process

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UK Follows the Central Portal Trend In Global Transparency

Posted by Greg Hawley

Jul 17, 2014 10:00:00 AM

As reporting earlier by the Polaris Insights Blog, reports indicate that that trend towards central transparency portals may continue in the UK. In accordance with the EFPIA Disclosure Code, ABPI member companies must disclose information on most payments to British HCPs and HCOs, beginning on January 1, 2015 (with first publication due June 30, 2016).

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What you need to know about the 2013 Open Payments dispute process

Posted by Ben Carmel

Jul 15, 2014 1:15:20 PM

 

With the official Open Payments 2013 dispute process kicking off yesterday, Polaris wanted to share some insight gained through conversations with individuals at CMS.

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Topics: Open Payments, CMS, Global Transparency

France Opens French Sunshine Online Portal to General Public

Posted by Greg Hawley

Jul 14, 2014 1:31:48 PM

 

Late last month, the French Health Ministry opened access to the French Sunshine database (entitled the Base des Données Publique Transparence) to the general public. The database contains records of all benefits, valued at over 10 Euros, paid by life sciences companies to a wide spectrum of French HCPs and HCOs, since January 1, 2012. Information regarding agreements with those HCPs and HCOs during that time period is also accessible on the website.

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Topics: Global Transparency, Bertrand

Looking back on week 1 of the CMS Aggregate Spend data submission

Posted by Ben Carmel

Jun 13, 2014 3:40:46 PM

With Week 1 of the CMS Open Payments data submission almost complete, Polaris takes a look at how we spent our week.

Hopefully everyone has been busy registering and submitting/reviewing data with CMS this week, and now that the first week is coming to a close, the Polaris team wanted to share some quick observations from across our client base.

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Topics: Aggregate Spend, Open Payments, CMS, Global Transparency

CBI Aggregate Spend West Conference Highlights

Posted by Russell Hirschorn

May 30, 2014 11:28:08 AM

CBI Aggregate Spend West Conference Highlights: Painful Adjustments to New Regulatory Realities

CBI’s 5th Annual Sunshine and Aggregate Spend West conference held in San Diego shed light on the many pain points life sciences organizations have faced, and continue to face in modifying corporate processes and procedures to accommodate for data collection and reporting activities as required by the Federal Sunshine Act.

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New CMS Phase 2 Guidelines

Posted by Alice Dong

May 28, 2014 4:49:43 PM

Manufacturers Finally Receive Long Awaited Phase 2 Reporting Guidelines from CMS Providing Limited Data Testing Options

 

Phase 2 Open Payments submission guidelines and timelines were issued last week by CMS as manufacturers try to get through final reporting hurdles over the coming weeks. The new guidelines come on the heels of CMS guidance earlier this month where it updated its reporting template requirements for Phase 2.

 

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Could New Connecticut Aggregate Spend Law Signal Trend For Other States?

Posted by Ben Carmel

May 22, 2014 2:03:44 PM

The announcement by the State of Connecticut that its aggregate spend reporting law will take effect in October of this year, with first reports due by January 1, 2015, merits close watching.

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Topics: Aggregate Spend

Marc Eigner Interviewed on Need for Meetings Planning Compliance Training

Posted by Ben Carmel

May 16, 2014 2:58:15 PM

Both meeting professionals and the suppliers who support their events are bumping up against new rules and regulations on the national, state, and company level. Marc Eigner talks to MeetingsNet about today’s urgent need for compliance training and certification among meeting planners and vendors.

Please find the video here.

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Transparency in Europe

Posted by Marc Eigner

May 16, 2014 10:40:11 AM

A key issue faced by the European life sciences compliance community that clearly came to the fore at this year’s CBI Global Transparency Congress held in London was the battle of the transparency vs. the data privacy directives and how meeting one mandate could mean violating the other as the situation currently stands. It was the question of the day throughout the two-day conference, in the session presentations and in the side conversations that many of us had while there. If there is one issue that’s keeping European life sciences executives up at night, it’s definitely this one and it’s one that their compliance counterparts in the U.S. have never had to face.

Companies in Europe are getting ready for a January 2015 deadline for various European variations of the U.S. Sunshine Act and to meet the requirements, just like in the U.S., they need to report much of their HCP/O spend data. Unlike in the U.S. though, they may need to ask the consent of every HCP/O they’ve made payments to, to report that information publicly as mandated by data privacy laws governing Europe. If doctors say no, that could red light the entire process in Europe. Complicating the issue even further is the fact that another data privacy law is expected to be enacted in Europe before the end of the year. Only in countries that take EFPIA voluntary guidance and turn it into actual law and not guidelines or codes, can life sciences companies possibly wiggle out of this conundrum. It was mentioned that some companies in Europe may not do business with physicians who don’t consent to making payment information public. It will be interesting to see if that’s a trend that takes off, but in any case, this is a very sticky issue that will surely impact European compliance efforts to some degree. Whatever happens, we think it will be in the best interests of life sciences companies and the HCP community in Europe to work together to voluntarily report this data to regulatory officials.

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