Preparing For Sunshine Act Rules

How Should Medical Device Technology Companies Prepare For Sunshine Act Rules?

medical-device-sunshine-act | Photo Courtesy of geomphotography http://www.flickr.com/photos/geomphotography/6779619531/sizes/q/in/photostream/

How much is the Physician Payment Sunshine Act going to add to the cost of meeting reporting requirements? Probably a lot more than most medical device technology companies realize, according to a recent article on the Mass Device website.

Jonathan Kellerman, compliance and risk assessment manager at PricewaterhouseCoopers, believes the ?make-it-or-break-it? variable that will determine how well each company handles the costs is its data management system. More mature, consistent and high-quality systems will have an easier time reporting to the Centers for Medicare & Medicaid Services.

It might be easier for smaller companies to comply with the new regulations simply because they have less data to report, but the bottom line is that the edge will go to those that embrace technology and use a CRM system to streamline the process

The new reporting requirements were released in February. As the article explains, ?the measure requires companies to track all interactions with physicians and start reporting the data to CMS by March 31, 2014.?

Specifically, any medical device technology company that interacts directly with a physician will be required to report expenses over $10 spent on that physician. That includes royalties, consulting fees and research fees. This mean there is even more information that companies now must collect. For example, if you buy a physician breakfast that costs more than $10, you?ll have to record that physician?s name, where you spent the money, when the meeting occurred and the reason for that interaction.

Many companies don?t have technology in place to record this type of information. While this can be done manually, using a CRM system is much more efficient. A CRM system can track physician information and record where and when expenses were incurred each day.

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Article originally posted on our CRM for Medical Device Organizations website.

Update on Sunshine Act Compliance Deadlines

Back in December I wrote a blog post about the Centers for Medicare & Medicaid Services (CMS) rule change for reporting on the Physicians Payment Sunshine Act. Original post here: http://i3.infinityinfo.com/blogs/entry/sunshine-act-compliance-deadlines-extended

The CMS had decided to extend the data collection start date from January 1, 2012 to ?some later date?. A few days ago, on May 3, the CMS provided some updated information in their blog (The CMS Blog). During the extended comment period they received over 300 comments. that?s a good thing that people are voicing their concerns.

The CMS still hasn?t issued a final date but says in their blog ?CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013? and ?CMS intends to release the final rule later this year?.

Some news is better than no news. The window is closing though for companies that will be required to report this information to the FDA. Time is ticking. We have helped a number of companies ensure their systems and processes are up date and compliant. If you are struggling with these rules, give us call, we are happy to help you too!