Is there a Sunshine Act question you hope CMS answers before August 1st? We have been able to ask CMS those questions in our name to preserve the anonymity of our clients while helping them get the clarity they need. The CMS Open Payments Help Desk is actively reviewing and responding to inquiries it receives. In the past few weeks alone, CMS has added responses to 11 new FAQs to its evolving list at: https://questions.cms.gov/faq.php?id=5005&rtopic=2017&rsubtopic=7803. Among these, CMS resolves the issue affecting many companies that manufacture devices which are not themselves reimbursed through the federal health care programs but for which payment is available through those programs for the procedure or test in which they are used. Specifically, CMS says that "if a medical device is used to perform a service that is reimbursable under Medicare, Medicaid, or CHIP, the device is considered a covered device for purposes of Open Payments, so long as it is of the type that by law requires premarket approval by or premarket notification to the FDA."
Another interesting and recent FAQ addresses distributors and wholesalers. CMS states that "Distributors and wholesalers (which include repackagers, relabelers, and kit assemblers) that hold title to a covered drug, device, biological or medical supply meet[] the definition of an applicable manufacturer. Distributors and wholesalers that do not hold title of a covered product will not be subject to the reporting requirements, unless they are under common ownership with an applicable manufacturer and provide assistance or support with respect to a covered drug, device, biological, or medical supply." CMS further clarifies that "A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and possesses the right to re-sell the inventory of the products that it has purchased." This could have significant implications for company distribution relationships and may warrant revisiting those agreements before August 1, 2013 when data collection begins.
I expect CMS will continue updating its FAQs and responses between now and August 1st, so companies would be wise to check for updates often.
Julie Tibbets is a partner in the Food, Drug & Device/FDA Practice of Alston & Bird LLP where she focuses her practice on advising manufacturers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related matters and interactions. This publication is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions. Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.