CMS Reporting: Names of each product

Question -

What level of specificity is required when reporting the name of each product?

Answer -

CMS has not provided guidance regarding the level of specificity required in reporting the “marketed name” for devices. A vast majority of companies are planning to approach the new data element by reporting at the brand level and we believe reporting at the brand level would be defensible in the absence of guidance from CMS to the contrary.

We are currently unaware of any manufacturer that is planning to report at the size/SKU level. Many manufacturers believe that reporting beyond the brand level would be very difficult and have concerns about reps’ abilities to accurately track interactions to that level of detail. Most companies are also comfortable reporting at the brand level because interactions are often related to a brand, and not necessarily any particular size or SKU within the brand.

You can access the recently updated guidance at https://www.cms.gov/OpenPayments/About/Law-and-Policy.html.