alarm clock

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly known as the Sunshine Law) and the Final Rule issued by the Centers for Medicare & Medicaid Services (CMS) in February 2013.  The tracked data must be reported to CMS by March 31, 2014. 

Now that tracking has started, manufacturers and GPOs may be asking, “what’s next?”.  Efforts during this critical time period between today and March 31, 2014 should be maximized.  Here are a few things to consider if you are sitting around today thinking that your work is done:

Internal Training and Communication.  For many companies, new tracking systems have been implemented and/or older systems have been modified to capture required data.  New policies and procedures also may have been established.  Take time to ensure that everything is working in order by reaching out to internal stakeholders, such as the field sales team and the finance department, to address questions and fix glitches as they arise.  Consider providing additional training or developing FAQs, and ensure that individuals within the company know whom to contact with questions or issues.   

Communication with Customers.  Manufacturers and GPOs assume that physicians and other health care providers know about the Sunshine Law and reporting obligations, but there is evidence suggesting a significant knowledge gap still exists.  Further, even if physicians and other health care providers are aware of Sunshine generally, they are less likely to understand the true depth and breadth of the reporting obligations.  This may create issues for manufacturers and GPOs when the reports are filed.  Manufacturers and GPOs should consider additional communication and/or educational opportunities for key customers to limit surprises that may damage relationships or strain internal resources.  Have letters been sent to health care professionals?  Have you provided a training session for your key speakers, consultants and researchers?  Do your field employees have a brochure that they can provide to physicians and other health care professionals regarding the Sunshine Law?  Have you trained your field employees specifically on how to address customer questions or concerns regarding the Sunshine Law?     

Capture Data Prior to August 1.  CMS has made it clear in FAQs that payments that were incurred prior to August 1, but not actually paid until August 1 or after, must be included in the first report.  This data may be challenging to capture for certain manufacturers based on the methodologies employed by the data tracking systems.  You will have enough to do when it comes to preparing the report early next year.  Take the time now to capture this data and cross one thing of your to-do list.     

Monitoring / Mock Reporting.  Manufacturers should consider evaluating the tracked data periodically rather than waiting for a data dump on January 1.  This gives manufacturers the opportunity to ensure that data is being tracked and to make changes if necessary now.  Manufacturers also should consider mock reporting to test whether the data is available, provided in the format required, and whether supporting documentation is needed and readily available.  Also, test vendors to ensure that they also are prepared to provide the data in a complete, accurate and timely manner. 

Pre-Disclosure Process.  Will your company pre-disclose payment and transfer of value data to “covered recipients” before the March 31, 2014 deadline to CMS?  Now is the time to make this decision and develop the process.  In what format will the data be disclosed?  What is the process for preparing this information?  How will questions from “covered recipients” be addressed?

Posted by Cooley

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