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.