Life Science Compliance Update

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June 25, 2014

Physician Payment Sunshine: Survey Offers Insight Into Companies’ Phase One Registration Experiences

There was a recent survey of 32 compliance and regulatory officers and legal counsel from life science companies about their experience with the Phase 1 reporting process of the Physician Payments Sunshine Act conducted by Polaris. Companies were responsible for submitting Phase 1 aggregate spend data by March 31, and will be responsible for Phase 2 submissions of detailed data by June 30. Most companies noted they were "somewhat satisfied" in their Phase 1 reporting processes, but many answers reveal that companies will have a busy sprint to the finish here as Phase 2 reports come due.

All but one respondent noted that they expected at least some variance between their Phase 1 and Phase 2 reports. Nearly half said there would be significant (12.5%) to moderate (34.4%) variances in what they report by the end of June. Particularly interesting, 22% of companies noted they discovered "several" specific payments that raised compliance concerns or necessitated significant follow-up.

In terms of companies' experiences with the technical side Phase 1 aggregate data submission, 30% noted that their file was not accepted and validated on their first attempt or that their file was still pending acceptance and validation. Respondents stated that they spent the most time for Phase 1 on transactional data validation (50%), HCP demographic validation (28.1%), submission formatting (12.5%), and CMS registration (9.4%).

We recently covered all the comments surrounding the Dispute Resolution process. Many physicians stressed the need for companies to notify them about any transfers of value before the data goes public. Polaris asked companies if they had notified any covered recipients prior to reporting data in Phase 1. Only 3 respondents indicated that they had. More than one-third of the respondents noted they were not planning to. Twenty-five percent plan to notify following submissions; 28% were likely still in the process of figuring it out.

Polaris asked whether companies were planning on reporting physician data as found exactly in the NPPES database verses their own information. We have reported on how notoriously inaccurate this database is. More than half the respondents (53%) indicated that they planned to use a hybrid of NPPES and their own internal data. A quarter of respondents stated they would use exactly what they found on the NPPES database; 19% noted they would use exclusively their own data source. One company said they would use neither of those methods.

More than a year after CMS' Final Rule, and following countless FAQs, many companies remain rightfully confused about many aspects of capturing and reporting data. "Delayed publication," and "teaching hospital identification," topped the list; 2 respondents stated "reprint valuation," and the last 7 respondents were most unclear about another aspect of reporting.

We have been covering companies' experiences with Phase 2 reporting over the last few weeks. So far, we have heard of several confusing idiosyncrasies with the system. Furthermore, many people have had to re-register with CMS for this process even after registering for Phase 1. This could take an addition few hours before the actual data submission can even begin, so we encourage companies to start this process sooner rather than later. We will be following these issues closely.


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