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Sunshine Act - Spreading Transparency and Reporting Requirements to Manufacturers Your Practice deals with

February 7, 2013

Prepared By:  Erica Youngerman, Esq.

It’s no secret that medical practices have been bombarded in recent years with more regulation, oversight and reporting requirements.  In yet another attempt to increase transparency in the medical field, the Centers for Medicare & Medicaid Services (CMS) have issued a final rule placing additional obligations to report on manufacturers and group purchasing organizations (GPOs).  The first report, due March 31, 2014, must cover the start of the data collection requirement on August 1, 2013 and continue through December 2013. 
 
While this rule has many detailed requirements, it may be summed up in two parts, as follows -

First, certain manufacturers of drugs, devices, biologicals and medical supplies that are covered by Medicare, Medicaid or CHIP must make annual reports of payments or transfers of value to certain covered recipients, including physicians.  For example, if a device manufacturer brings lunch to your office, and it costs over a specified amount per person, the manufacturer will be required to report the per person cost for each physician who eats the lunch.
 
Second, certain manufacturers and GPOs must now annually report ownership or investment interests held by physicians and their immediate family members and any payments or transfers of value to these physicians. 
 
These reports are required to include detailed information regarding the physician, including the individual practitioner’s NPI number, so be advised that your interactions with manufacturers will now be on file with CMS.  Additionally, some of the information from these reports will be displayed on a website available to the public.
 
Both of these reporting requirements may result in additional scrutiny for physicians based on the reports received, which is yet another reason to ensure you are practicing compliantly.  While you may be thinking compliance by the manufacturers may not be that high, be advised that their failure to comply may subject them to SIGNIFICANT civil monetary penalties.  So, what does this mean for you and your practice?  Simple, you need to make sure you are not receiving inappropriate remuneration from any of the aforementioned parties.  If you are not sure if that is the case, contact us -  I may be reached at EYoungerman@Kirschenbaumesq.com or at (516) 747-6700 x. 308 or Jennifer may be reached at (516) 747-6700 x. 302 or at Jennifer@Kirschenbaumesq.com.
 
For more information, the final rule is available here:  https://www.federalregister.gov/articles/2013/02/08/2013-02572/transparency-reports-and-reporting-of-physician-ownership-or-investment-interests-medicare-medicaid


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