This post was also written by Ruth Holzman.

The IRS has issued updated guidance to drug manufacturers on the Affordable Care Act’s annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The guidance addresses submission of required information, IRS notification of covered entities of their preliminary fee calculation; submission of error reports for the dispute resolution process, and notification of final fee calculations. Among other things, the guidance provides that:

• Each covered entity that elects to submit a completed Form 8947, “Report of Branded Prescription Drug Information,” for the fee year 2012 (reporting sales for the sales year 2010) must do so by December 15, 2011.
• IRS will mail each covered entity a paper notice of its 2012 preliminary fee calculation by April 2, 2012. This mailing will include an NDC attachment that lists the covered entity’s NDCs and the sales data reported to the IRS by each governmental program.
• A covered entity may request a CD-ROM with the NDC attachment in an Excel spreadsheet. The request must be made by March 1, 2012 by telephone or by e-mail.
• If a covered entity wishes to submit an error report regarding its preliminary fee calculation it must do so by May 16, 2012. To file an error report, the covered entity must use the template on a CD-ROM that was mailed to it with its preliminary fee calculation.
• IRS will notify each covered entity of its final fee calculation for 2012 by August 31, 2012.
• The covered entity must pay this fee by September 30, 2012.