The Internal Revenue Service has issued a final rule to establish a 2.3 percent federal tax on the sale of certain medical devices.

The tax is expected to raise $29 billion over 10 years to pay for provisions of the health reform law. There are multiple exemptions to the tax, including custom procedure kits that are assembled in hospitals for their own use--an exemption that the Premier provider alliance praised. “With hospitals already contributing $155 billion to the expansion of health coverage, adding this additional tax on providers would have been unacceptable,” the organization noted in a statement.

Also exempt are retail consumer items such as eyeglasses, contact lenses, and hearing aids; over-the-counter home use tests; durable medical equipment and prosthetic and orthotic devices that do not require insertion or implantation by a physician; parenteral and enteral nutrients, equipment and supplies; therapeutic shoes; and supplies “necessary for effective use of DME,” among others.

Sales and upgrades of software associated with a device also are exempt from the tax if the software is not required to be separately listed as a device.

The rule is available here with publication Dec. 7 in the Federal Register.

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