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The Physician Payments Sunshine Act (Open Payments) requires medical device manufacturers, suppliers and others to begin recording data about gifts, payments and transfers of value to healthcare providers starting this last August. As the first annual reporting deadline to the Center for Medicare & Medicaid Services (CMS) approaches on March 31 of next year, many physicians and dental practitioners may still be pondering exactly how the Sunshine Act will affects their practice and bottom line. Read on for answers to pressing questions many dentists have about the new rule.
What is the rule?
In a nutshell, the rule states that if a dentist has a financial relationship or ownership or investment interest in an applicable manufacturer, then that manufacturer is required to gather and report data about that dentist and the nature of the relationship. Even ownership interest held by a dentist’s immediate family members (parent, child, spouse, sibling, stepparent, stepchild, stepsibling, brother or sister-in-law, grandparent, or grandchild) is required to be reported. According to the CMS, the rule is intended to create greater transparency around financial relationships, prevent inappropriate influence on research and education, and reduce the risk of increased health care costs.
Who is required to collect and report data?
According to the CMS website, only “applicable manufacturers” are responsible for collecting and reporting data. Included in this category are medical device manufacturers, pharmaceutical companies and medical suppliers. Basically, companies are required to report if their products require premarket approval or clearance from the Food and Drug Administration, and if payment for those products can be made through Medicaid, Medicare or the Children’s Health Insurance Program.
Applicable manufacturers must organize and report all payments or transfers of value within the following categories:
What kind of data will be reported about me?
On top of the information above, manufacturers must also report information related to your (or your family member’s) ownership interests in the company, including the amount invested, the value of the ownership interest, as well as any other direct or indirect payments made as a result of the ownership interest.
Who has access to the information about me that has been reported?
Most importantly, you do. You are required to register with the CMS to be notified of supposed payments reported and are allowed to review â or dispute â payments before they are posted on the CMS website. Once that information has been posted, however, it becomes available to the general public.
Are there any penalties if I don’t comply with the rule in some way?
Although there are monetary penalties for applicable manufacturers that don’t report on a timely basis, or that knowingly omit required data, you don’t face penalties of any kind because you aren’t required to report anything.
What should I do now?
First, register at the CMS website to receive notifications, if you haven’t already.
Second, perform a cost/benefit analysis to decide if the financial relationships you currently have with applicable manufacturers â if they fall under the reporting requirements â are worth it to you to be made public.
Third, come up with a plan on how to decide whether or not to create financial relationships with applicable manufacturers in the future, keeping in mind how they might be perceived by your patients, employees and potential investors in your practice.