AAHomecare, working with its Manufacturer Device Tax Working Group and Regulatory Council, has recommended exempting all HME items and supplies from the medical device excise tax required by the Patient Protection and Affordable Care Act of 2010, commonly known as health care reform.
AAHomecare’s recommendation was included in comments submitted last week in response to the Internal Revenue Services’ proposed rule to implement the excise tax on the sale of certain medical devices.
The proposed rule includes a “safe harbor” that specifically excludes items classified by the Food and Drug Administration as over the counter, according to AAHomecare. Tests that would determine whether or not the new rule includes home medical equipment not excluded by the safe harbor are: Is the device available to consumers at retail?; and is it designed and intended for use by consumers in a non-medical setting?
AAHomecare has recommended that the proposed rule include a “bright-line” test that would explicitly include all HME devices and supplies within an expanded safe harbor because they do meet each of the tests. If the IRS chooses not to include this recommendation, AAHomecare has asked that the rule be clarified so respiratory HME devices such as those used in home oxygen therapy, nebulizers, positive airway pressure devices are exempt even though they are classified as anesthesiology devices under FDA regulations, not over-the-counter products.
An IRS public hearing is set May 16, and Tyler Wilson, AAHomecare president, is expected to testify.
Monday, May 14, 2012