It is clear that applicable life sciences manufacturers are struggling to meet the standard.
New York, NY (PRWEB) June 05, 2014
A high level of uncertainty around collected and submitted data characterized the first phase of mandated Federal Open Payments reporting by life sciences companies with over 20% saying reports initially filed were rejected before being accepted upon resubmission, according to a new survey of senior life sciences compliance, regulatory and legal officers.
The poll, conducted by Polaris, a global life sciences compliance consulting and technology firm, showed mixed results. Companies were somewhat confident in their reporting processes yet there was evidence that some faced significant hurdles in their attempt to meet the Phase 1 reporting deadline last March 31st. There is even some question about whether the ways these hurdles were addressed may affect Phase 2 reporting as nearly 47% of survey respondents said there will be significant (12.5%) to moderate (34.4%) variances in what they report by the next deadline.
“We wanted to hear from the life sciences compliance community about what their Phase 1 preparation, reporting and filing process was like and how that might impact Phase 2,” said Andy Bender, President, Polaris. “We hope the findings from this survey provide solutions for all stakeholders in the Sunshine Act moving forward.”
Specifically, questions were raised about information captured for the Sunshine Act. Almost 44% of respondents said there was a minimum of one (22%) to several (22%) specific discovered payments that either raised compliance concerns or necessitated significant follow-up. Companies also seemed to be confused about what kinds of data should be captured. Most respondents (32%) said there were a range of areas they weren’t sure they should include. Nearly 23% said identifying a Teaching Hospital caused confusion while nearly 20% had questions about how to report meals provided for attendees of CME programs. Other areas of concern were delayed publication of data (19.4%) and valuation of reprints (6.5%).
The survey also raised concerns about how organizations verified the information they gathered before submission. To that point, survey respondents reported a variety of methods for validating the accuracy of data reported. These ranged from solely checking against source system data (56%) to comparing aggregate data to financial records (16%). Another fifth of respondents indicated they used other undisclosed methods for data verification. Surprisingly, there were some respondents who said they never validated their data prior to submission (6%).
When asked about how confident they were in the veracity of the data they collected and disclosed, there were a range of responses. Nearly 60% of survey respondents were only somewhat satisfied with the covered recipient data they submitted on March 31st. Only 16% answered that they were very satisfied with what they disclosed. Another quarter of all respondents were either not satisfied (16%) or could not answer whether they were or weren’t satisfied (9%) with the data they ultimately reported.
“Based on the expected high variances between Phase 1 and Phase 2 reporting and the low levels of satisfaction with data submitted, as shown in the survey findings, it is clear that applicable life sciences manufacturers are struggling to meet the standard of submitting timely, complete and accurate data in their reporting efforts,” said Alice Dong, Senior Consultant, Polaris. “This difficulty is further complicated by insufficient CMS guidance in a number of reporting areas as well as the complexity of CMS registration many organizations have experienced.”
The survey findings also highlighted how many companies are struggling to get a more complete understanding of data around their engagements with healthcare practitioners (HCPs). Respondents said that they only spent 28% of their time in Phase 1 verifying HCP information they were going to report on. They said they spent the majority of their Phase 1 time only validating their aggregate transactional data (50%). Others responded that nearly 22% of their time was spent on administrative functions like formatting reports or the registration process with CMS.
Further, the findings raised some doubts about whether objective sources were being used to validate and report physician-derived data. Almost 22% of respondents indicated they sourced their physician data either from an internally created master database or source (19%) or did not indicate where they sourced it from. Others said that they neither used an official NPPES physician database nor did they extract the data internally (3%). Another 53% percent of those surveyed responded that they employed some hybrid combination of data derived from the NPPES source and their own internal data to report physician payment information.
More than 65% of respondents either did not notify covered recipients of data related to them for validation prior to report submission (28%) nor did they plan to notify them about what data they were planning to disclose post-submission (38%). Only 25% said they planned to notify contracted parties following report submission. Only a little over nine percent of all survey participants said they had actually already notified engaged parties about related payment data prior to submission.
Polaris surveyed via e-mail and social media 35 senior life sciences company compliance and regulatory officers and legal counsel from April 17 thru May 22 of 2014 on their experience with the Phase 1 reporting process of the U.S. Sunshine Act.
Polaris is a global life sciences consulting and technology firm exclusively focused on the compliance needs of the pharmaceutical, biotech and medical device industries.
Polaris understands that there is more than one way to meet your compliance needs. Using a process-driven approach, Polaris will tailor a solution that is efficient, scalable and unique to your needs.
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