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Sushine Act Compliance at Medical Congresses


Beware: Sunshine Act Fines are Severe

Pharma and Medical Device manufacturers beware: if you exhibit at trade shows where the attendees are physicians and other HCP’s, you can’t give them anything over $10 in value unless you report it to the government in a very specific format.And if you already have  given a doctor more than $100 in value this year, you must report even items under $10.  And if you think you might give a doctor and aggregate of more than $100 this year, you must report items under $10. CMS expects you to know all of this at a busy trade show or medical meeting, so why not just report everything and play it safe?  Some companies do exactly that, but wait until after the show to find the correct CMS reporting data for each HCP. This is not only time consuming but also highly inaccurate: many HCP’s have not updated their NPPES (CMS) record so the address is hard to find. The barcoded attendee badge with the HCP’s information is this not the information required by CMMS–it’s the HCP’s listed practice address that is required. Post-show matching an HCP’s badge scan (their attendee badge address might be their home in New Jersey) with the CMS data (the HCP works across the river in Philadelphia) is difficult and erroneous. If you don’t correctly report,, your company can be fined from $1,000 per HCP (for inability to match or other mistakes) to $10,000 per incident (for ignoring the rule and not capturing or reporting). The fines can be , just over $1 MM per year.

What Reporting Data Must You Collect?

The Sunshine Act says you must collect the HCP’s official designation (MD, NP, DDS, etc.), the HCP’s NPI number, the sate(s) in which the HCP is licensed and the and the associated numbers, the practice address (as is listed in the CMS database even if it is out of date) and the HCP’s primary taxonomy number.  You must also report the amount of the item, the type of event, and many other data points.

What is Required by Law

Anything valued at $10 or more that you give to a Health Care Professional (HCP) who is an MD, DO, PA, NP, Dentist, Orthodontist, Podiatrist,Chiropractor or Optometrist must be reported as a Transfer of Value (ToV). The exception to rule is if the food is given to everyone at the congress regardless of who they are and only IF the participants are not readily identifiable (if they don’t have a name badge with MD or if the name badge does not have a bar code to scan that would easily reveal their identity).

Why is this so difficult?

Many HCP’s register for conferences and medical meetings using their home address.  Others have recently changed practice locations or hospitals. Still others have forgotten to update their CMS record for some time. When an HCP’s conference attendee badge is printed, a bar code is included on the badge which contains the information that was provided in the registration process. It never contains the four fields required by CMS and the trade show rental scanners merely capture the bar code data and store it to a file. After the show, the research begins for each HCP to locate the i the CMS database, extract the data required by CMS and place it in a report.  Abysmal match-up rates of under 25% are common and outdated, inadequate reporting templates are often used. If you were audited, the results would be disastrous.

Clearly, the best way to find an HCP’s information is to locate it at the time of the badge scan.  It is the only way to know for sure since the HCP can view the match choices and verify which one  belongs to them. To do this requires an up-to-date database of every HCP in the United States (more than three million records) and a very fast matching algorithm to find matches in less than a second.  But how can this be done if the addresses often do not match and many times are in other states than what is listed in the HCP’s bar code?

Matching Data On-Site in Real-Time with NewLeads

The best way to find the NPI numbers and the rest of the government-required data is is to scan badges and find matches on-site, in real time. The NewLeads NPI Match system uses an optimized proprietary database that includes all of the CMS reuqired data and every HCP in the US.. Using filters, organization and data optimization, NewLeads can match a doctor’s home address (on the HCP’s conference bar coded name badge) with their practice that is 60 miles away–in less than a second. Once the match is made, all of the required government data is retrieved from our database, including the NPI #, the state and license number, the practice address and the primary taxonomy number. Here’s a real snapshot of an actual badge scan and what the system looks like on an iPad.  The google map was added to provide a visual of where we found the HCP’s practice: