26 CFR 51.5T - Fee calculation (temporary).

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There are 3 Updates appearing in the Federal Register for 26 CFR 51. View below or at eCFR (GPOAccess)
§ 51.5T Fee calculation (temporary).
(a) Fee components—
(1) In general. For every fee year, the IRS will calculate a covered entity's total fee as described in this section. For each fee year after 2011, the IRS will determine a covered entity's total fee by applying, if applicable, the adjustment amount described in paragraph (e) of this section to the entity's allocated fee described in paragraph (d) of this section.
(2) Calculation of branded prescription drug sales. Each covered entity's allocated fee for any fee year is equal to an amount that bears the same ratio to the applicable amount as the covered entity's branded prescription drug sales taken into account during the sales year bears to the aggregate branded prescription drug sales of all covered entities taken into account during the sales year.
(3) Applicable amount. The applicable amounts for fee years are—
Fee year Applicable amount
2011 $2,500,000,000
2012 2,800,000,000
2013 2,800,000,000
2014 3,000,000,000
2015 3,000,000,000
2016 3,000,000,000
2017 4,000,000,000
2018 4,100,000,000
2019 and thereafter 2,800,000,000
(3) Sales taken into account. A covered entity's branded prescription drug sales taken into account during any calendar year are as follows:
Covered entity's branded prescription drug sales during the calendar year that are: Percentage of branded prescription drug sales taken into account is
Not more than $5,000,000 0
More than $5,000,000 but not more than $125,000,000 10
More than $125,000,000 but not more than $225,000,000 40
More than $225,000,000 but not more than $400,000,000 75
More than $400,000,000 100
(b) Determination of branded prescription drug sales. The IRS will compile each covered entity's branded prescription drug sales for each Program by NDC. Each NDC will be attributed to the covered entity that owns the NDC as of the end of the day on December 31st of the sales year. For a covered entity that is a controlled group, this includes all NDCs that a member of the covered entity owns as of the end of the day on December 31st of the sales year. For this purpose, the IRS may revise the list of NDCs as a result of information received in the dispute resolution process, and the data the IRS uses to produce the final fee calculation will include any revisions provided by the Agencies at the completion of the dispute resolution process. Each covered entity's branded prescription drug sales will be reduced by its Medicare Part D rebates and Medicaid state supplemental rebate amounts in the following manner. If CMS has the rebate information for these Programs for a sales year, CMS will report to the IRS branded prescription drug sales net of rebates. If CMS does not have the rebate information for these programs for a sales year, the IRS will reduce the branded prescription drug sales reported for these Programs by rebates reported by the covered entities on Forms 8947.
(c) Determination of sales taken into account.
(1) For each sales year and for each covered entity, the IRS will calculate sales taken into account. The resulting number is the numerator of the ratio described in paragraph (d)(1) of this section.
(2) For each sales year, the IRS will calculate the aggregate branded prescription drug sales taken into account for all covered entities. The resulting number is the denominator of the ratio described in paragraph (d)(2) of this section.
(d) Allocated fee calculation. For each covered entity for each fee year, the IRS will calculate the entity's allocated fee by multiplying the applicable amount from paragraph (a)(2) of this section by a fraction—
(1) The numerator of which is the covered entity's branded prescription drug sales taken into account during the sales year (described in paragraph (c)(1) of this section); and
(2) The denominator of which is the aggregate branded prescription drug sales taken into account for all covered entities during the same year (described in paragraph (c)(2) of this section).
(e) Adjustment amount. For each fee year after 2011, in addition to the allocated fee computed under paragraph (d) of this section, the IRS will also calculate an adjustment amount that reflects the difference between the allocated fee determined for the covered entity in the immediately preceding fee year, using data from the second calendar year preceding that fee year, and what the allocated fee would have been for that entity for the immediately preceding fee year using data from the calendar year immediately preceding that fee year. For example, for 2012, the adjustment amount for a covered entity will be the difference between the entity's 2011 allocated fee, using 2009 data, and what the 2011 allocated fee would have been using 2010 data. Although the adjustment reflects a revision of the prior year's fee based on data from the year immediately preceding the prior fee year, the adjustment is only taken into account by adding it to or subtracting it from the allocated fee computed under paragraph (d) of this section for the current fee year to arrive at the total fee for the current fee year.

Title 26 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 26.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-26; vol. 79 # 187 - Friday, September 26, 2014
    1. 79 FR 57783 - Branded Prescription Drug Fee; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF THE TREASURY, Internal Revenue Service
      Correcting amendment.
      This correction is effective September 26, 2014 and applicable beginning July 28, 2014.
      26 CFR Part 51

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United States Code
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Title 26 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 26 CFR 51 after this date.

  • 2014-09-26; vol. 79 # 187 - Friday, September 26, 2014
    1. 79 FR 57783 - Branded Prescription Drug Fee; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF THE TREASURY, Internal Revenue Service
      Correcting amendment.
      This correction is effective September 26, 2014 and applicable beginning July 28, 2014.
      26 CFR Part 51