Internal Revenue Bulletin: 2012-52
December 27, 2012
Final regulations under sections 4375, 4376, and 4377 of the Code provide guidance on determining which health insurance policies and self-insured health plans and arrangements are subject to fees for the Patient-Centered Outcomes Research Trust Fund, and also on the requirements for calculating, reporting, and paying the fees.
Final regulations provide guidance under section 4191 of the Code on the excise tax on sales of certain medical devices. The tax is effective for sales after December 31, 2012. The final regulations provide a regulatory definition for a “taxable medical device,” and standards for determining if a device is not a taxable medical device because it is generally purchased by the general public at retail for individual use. The final regulations also provide guidance for calculating the tax on lease or installment sale payments where the payments are made on or after January 1, 2013, under a pre-2013 contract. The final regulations will affect medical device manufacturers and importers.
This notice provides interim guidance relating to the excise tax on medical devices imposed by section 4191 (the “medical device excise tax”) of the Code. Section 4191 was enacted by section 1405 of the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (124 Stat. 1029 (2010)), in conjunction with the Patient Protection and Affordable Care Act, Public Law 111-148 (124 Stat. 119 (2010)).
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