How to Comply with the Sunshine Act: Best Practices and Critical Guidelines

Will the Sunshine Act force medical device companies to lay off even more employees? Perhaps at a rate of 2-4 per year? Let’s do some simple math:

It’s estimated that compliance with the Sunshine Act will cost medical device companies about $200,000 per year. If the average annual salary of an employee within a medical device company is $65,000, that’s roughly 3 employees. Ouch.

I think the overwhelming majority of the American public would like to see more transparency between physicians and medical device companies. But are the outrageous compliance costs of the Sunshine Act worth 2-4 jobs per company per year? Better yet, once the data from the legislation is made public, will ‘Joe Patient’ even be able to interpret it?

To help answer some of these questions, enter David Hoffmeister, partner at Wilson Sonsini Goodrich & Rosati. In this interview, David provides us with actionable rules regarding physician and HCP consulting arrangements in addition to helping us understand the overall impact of the Sunshine Act on medical device companies.

Interview Highlights with David Hoffmeister

• Origin, scope, and purpose of the Sunshine Act and the problems this legislation hopes to solve.

• Will patients be able to decipher the public data resulting from the Sunshine Act? And will they even care?

• Resource constraints that will be forced upon medical device companies because of the Sunshine Act.

• How will medtech startups be affected by the legislation?

• Consequences within medical device companies if adequate policies are NOT put in place. Hint: David thinks it’s like driving a car without car insurance.

• Policies and procedures that medical device companies need to have in place in order to comply with the Sunshine Act. We also cover the 2 exceptions.

• Are there any loopholes in the Sunshine Act that medical device companies can exploit?

• Importance of consistent ‘needs assessments’ pertaining to HCP consultants.

• David’s lasting advice to medtech companies in regards to the Sunshine Act.