AdvaMed has submitted a 20-page letter to the IRS detailing difficulties presented by the tax and recommending ways to achieve “effective implementation without undue burden on the medical device industry.”

In the letter, AdvaMed says that its comments are intended to both amplify written comments submitted before the proposed and final regulations were issues as well as to provide additional recommendations for Treasury and IRS to consider.

Specifically, AdvaMed addresses the following six areas of concern:

  • Use of per purchaser vendee statements as proof of export or further manufacture rather than per sale statements
  • Interim constructive price rules set forth in Notice 2012-77
  • Excise tax treatment of rebates and discounts
  • Taxability of demonstration items and loaned devices
  • Charitable donations
  • Device excise tax treatment of repairs and modifications.

Although AdvaMed credits the IRS with addressing some of its concerns, it notes that “the tax remains complex for medical device manufacturers to implement and administer, and issues continue to arise as companies proceed to implement the tax across the broad array of medical devices and complex supply chains that characterize this global industry.”