Branded Prescription Drug Sales Part 2 of 3

Section 9008(a) imposes the fee on each covered entity engaged in the business of manufacturing or importing branded prescription drugs. Section 9008(d)(1) defines a covered entity as “any manufacturer or importer with gross receipts from branded prescription drug sales.” For purposes of section 9008(a), a manufacturer or importer is the person identified in the Labeler Code of the National Drug Code (NDC) for a branded prescription drug. The NDC is an identifier assigned by the Food and Drug Administration (FDA) to a branded prescription drug, as well as other drugs. The Labeler Code is the first five numeric characters of the NDC or the first six numeric
characters when the available five-character code combinations are exhausted.

Section 9008(d)(2) provides a controlled group rule under which all persons treated as a single employer under section 52(a), 52(b), 414(m), or 414(o) of the Internal Revenue Code (Code) shall be treated as a single covered entity.

For this purpose, a foreign entity subject to tax under section 881 is included within a controlled group under section 52(a) or 52(b). This controlled group rule will be applied as of the end of the day on December 31 of the sales year. All persons treated as a single employer under section 9008(d)(2) are jointly and severally liable for the fee. See section 9008(d)(3). In the case of a controlled group that is treated as a single covered entity under section 9008(d)(2), the controlled group must identify a single person as the “designated entity” that may act for the controlled group with respect to the section 9008 fee. If the controlled group, without regard to foreign corporations included under section 9008(d)(2)(B), is also an affiliated group that filed a consolidated return for federal income tax purposes, the designated entity is the common parent of the affiliated group as identified on the tax return filed for the sales year.

In all other situations, the controlled group must select a person as the designated entity on Form 8947, Report of Branded Prescription Drug Information1 (discussed further below), which is signed by the designated entity under penalties of perjury, stating that all the manufacturers or importers of branded prescription drugs who are members of the covered entity have consented to the selection of the designated entity.

Sales taken into account go to Section 9008(b) provides that the annual fee for each covered entity is calculated by determining the ratio of (i) the covered entity’s branded prescription drug sales taken into account during the preceding calendar year to (ii) the aggregate branded prescription drug sales taken into account for all covered entities during the same year, and applying this ratio to the applicable amount as specified in the statute. “Sales taken into account” means sales exclusive of certain orphan drugs and after application of the percentage adjustment table in section 9008(b)(2). Section 9008(b)(1) provides that the calculation of the fee in any given year is based on branded prescription drug sales in the immediately preceding calendar year.

1 The Office of Management and Budget approved Form 8947 under control number 1545-2192.
Section 9008(b)(3) provides that the Secretary of the Treasury shall determine the amount of each covered entity’s fee. In determining that amount, the Secretary may rely on reports submitted by the Agencies and any other source of information. Section 9008(i) also provides the Secretary with regulatory authority to carry out the purposes of the statute.

The IRS and Treasury Department have determined that, although the DOD and VA are expected to have complete data on branded prescription drug sales for the calendar year immediately preceding the fee year within the time frame necessary to administer the fee, CMS is not expected to have comparable data because it cannot complete its data processing within the necessary time frame. Accordingly, the IRS and Treasury Department will calculate the fee based on the branded prescription drug sales data provided by the Agencies for the second calendar year preceding the fee year. Because the use of the second preceding year, rather than the immediately preceding year, as the sales year may affect the amount of the fee paid by any
particular covered entity, the fee due in every year after 2011 will include an adjustment
amount.

An adjustment amount will be calculated for each NDC and will be added or subtracted, as appropriate, to the fee otherwise payable by the covered entity responsible for the NDC in the fee year in which the adjustment is calculated. The adjustment amount added or subtracted to the amount payable in a fee year will reflect the difference between the fee determined for the NDC in the immediately prior fee year, using data from the second calendar year preceding that fee year, and what the fee for that NDC would have been for the immediately prior fee year using data from the calendar year immediately preceding that prior fee year. For example, the amount due from a covered entity in the 2012 fee year will include an adjustment amount for each
NDC for which the covered entity is responsible in 2012 equal to the difference between
the 2011 fee associated with that NDC using 2009 data, and what the 2011 fee for that
NDC would have been using 2010 data.

To calculate the adjustment amount for an NDC, the IRS will first determine two
ratios: one based on data from the second preceding calendar year; and the other
based on data from the third preceding calendar year. In both cases, the numerator of
the ratio is the sales taken into account for the particular NDC during the relevant
calendar year, and the denominator of the ratio is aggregate branded prescription drug
sales taken into account for all NDCs during the relevant calendar year. For each NDC,
the IRS will then take the difference between the ratio using second preceding year data
and the ratio using third preceding year data and multiply that amount by the applicable
amount of the fee for the relevant fee year, as set forth in section 9008(b)(4), to determine an adjustment for the NDC. The adjustment amount for any particular NDC will then be added to, or subtracted from, as appropriate, the amount of the fee otherwise payable by the covered entity associated with the NDC for the fee year in which the adjustment amount is calculated.

For example, in 2012 the fee payable by each covered entity will consist of two components. First, the applicable amount for 2012 will be allocated to the covered entities based on sales data for 2010 (i.e., the second preceding calendar year).

Second, an adjustment amount will be calculated in 2012 for each NDC with respect to the 2011 fee year, by multiplying (i) the difference between the sales ratio determined using 2010 data and the sales ratio determined using 2009 data by (ii) the applicable amount of the fee for 2011. The adjustment amount for each NDC will then be added to, or subtracted from, as appropriate, the fee otherwise payable in 2012 by the covered entity associated with the NDC for the 2012 fee year.

The adjustment amount is applied only with respect to the amount of the fee otherwise payable by the relevant covered entity in the year in which the adjustment is calculated, and is not a refund, credit, or recalculation of a fee payable by any covered entity in any preceding fee year. In any given fee year, the amount assessed by the IRS will be based on data provided to it by the Agencies. The IRS does not intend to recalculate either the fee allocations or the adjustment amounts based on data that becomes available after those amounts are assessed.

The final article will be about the information requested from covered entities, information provided by the agencies and fee calculations.

As always if you have any questions or comments please email me at rondazaragoza@gmail.com. I will try and reply to your question within 24-48 hours of receipt.

Branded Prescription Drug Sales Part 1 of 3

Notice 2010-71

This notice provides guidance on the annual fee imposed on covered entities
engaged in the business of manufacturing or importing branded prescription drugs by
section 9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-
148 (124 Stat. 119 (2010)), as amended by section 1404 of the Health Care and
Education Reconciliation Act of 2010 (HCERA), Public Law 111-152 (124 Stat. 1029
(2010)). All references in this notice to section 9008 are references to section 9008 of
the ACA, as amended by section 1404 of HCERA.

Part I of this notice describes a proposed methodology for calculating the section
9008 fee. Part II of this notice describes how the Internal Revenue Service (IRS) will
use this proposed methodology to provide each covered entity with a preliminary 2011
fee calculation. The IRS and Treasury Department intend that a covered entity’s
preliminary fee calculation for 2011 will serve as a basis for comments by the covered
entity on the proposed methodology. Part III of this notice solicits public comments on
all aspects of the notice.

Part I – Proposed Methodology for Calculating the Fee

Section 9008(b)(4) sets an applicable fee amount for each year, beginning with
2011, that will be allocated among covered entities with aggregate branded prescription
drug sales of over $5 million to specified government programs or pursuant to coverage
under such programs. Section 9008(e)(2) provides that “branded prescription drug”
means (i) any prescription drug the application for which was submitted under section
505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), or (ii) any
biological product the license for which was submitted under section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a)). The specified government programs are
the Medicare Part B program, the Medicare Part D program, the Medicaid program, any
program under which branded prescription drugs are procured by the Department of
Veterans Affairs, any program under which branded prescription drugs are procured by
the Department of Defense, and the TRICARE retail pharmacy program (collectively,
the Programs). The applicable fee amount is allocated among the covered entities
using a formula specified in section 9008(b) based on sales to the Programs, which
sales data is to be provided by the Centers for Medicare and Medicaid Services of the
Department of Health and Human Services (CMS), the Department of Veterans Affairs
(VA), and the Department of Defense (DOD) (collectively, the Agencies).

There are two years relevant to the calculation of the section 9008 fee – the
calendar year in which the fee must be paid (herein referred to as the fee year) and the
calendar year of the branded prescription drug sales, which will be used to determine
the amount of the fee (herein referred to as the sales year). As discussed more fully
below, the IRS and Treasury Department are proposing to use the second calendar
year preceding the fee year as the sales year for purposes of calculating the section
9008 fee. An adjustment amount will also be calculated as discussed below.
The next article will cover the definition of covered entities, sales taken into account and the adjustment methodology.

As always if you have any questions or comments please email me at rondazaragoza@gmail.com. I will try and reply to your question within 24-48 hours of receipt.