Form 8947 - Report Of Branded Prescription Drug Information Page 7

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7
Form 8947 (Rev. 10-2011)
Page
General Instructions
Who Files
Generally, each manufacturer or importer of branded prescription drugs
Section references are to the Internal Revenue Code unless otherwise
with sales to specified government programs (or sales due to coverage
noted.
under the programs) may submit Form 8947. Each entity that is treated
What's New
as a single covered entity is requested to file one Form 8947, providing
all requested information for each such manufacturing and reporting
If you are filing this report for the second year (a subsequent year filer),
entity, as described in these instructions.
you are not required to resubmit all of the branded prescription drug
Schedules A, B, C, D, and E. All filers must complete page 1 and page
information submitted on your report filed for sales year 2009. For
6, which includes Schedule E, Summary of Form 8947, and Part II,
reporting sales year 2010 information, Form 8947 is expanded with new
Signature of Official Signing On Behalf of the Covered Entity (Single-
Schedules A, B, C, D, and E, allowing subsequent year filers to report
Member, Common Parent of an Affiliated Group, or Other Designated
entity information and branded prescription drug information changes
Entity) and Consent by the Common Parent or Designated Entity (if
only. See Schedules A, B, C, D, and E under Who Files below.
applicable).
Medicare Part D rebate information is now directly reported to the IRS
First time filers must also attach Schedule A, Branded Prescription
by the Centers for Medicare and Medicaid Services and is no longer
Drug Information—First Time Filers Only.
reported on this form. However, it is still necessary for covered entities
to report Medicaid state supplemental rebate information on Schedules
Subsequent year filers with changes to report must attach Schedule
A, B, D, and E, as applicable.
B, Branded Prescription Drug Information NDC Additions and Deletions,
or Schedule C, Branded Prescription Drug Information Orphan Drug
Purpose of Form
Changes—Previously Reported NDCs, or both.
Use Form 8947 to report the following information for branded
Subsequent year filers reporting Medicaid state supplemental rebates
prescription drugs sold by covered entities to specified government
for sales year 2010 drug sales must attach Schedule D, Branded
programs (or sales due to coverage under the programs) during sales
Prescription Drug Medicaid State Supplemental Rebates—Previously
year 2010.
Reported NDCs, to report NDCs and their Medicaid state supplemental
• National Drug Codes (NDCs).
rebates. See Completing Pages 1 and 6, and the Correct Schedule(s)
below.
• Medicaid state supplemental rebate information.
When To File
• Section 45C orphan drug information.
• Designated entity and controlled group members information, if
File Form 8947 by December 15, 2011, to report sales year 2010
applicable.
information.
The IRS will use the information you submit on Form 8947 to calculate
Definitions
the annual fee for branded prescription drug sales ("the fee"). The fee is
imposed by section 9008 of Public Law 111-148 (Patient Protection and
For the definitions of covered entity, single-person covered entity, and
Affordable Care Act), as amended by Public Law 111-152 (Health Care
designated entity, see Item B. Covered Entity Information under Specific
and Education Reconciliation Act of 2010) (the “Act”).
Instructions.
For more information, see Definitions and Item B. Covered Entity
Information below. Also, see Temporary Regulations sections 51.1T
through 51.12T, and section 51.6302-1T.
Completing Pages 1 and 6, and the Correct Schedule(s)
First time filer
Subsequent year filer with
Subsequent year filer with no
Subsequent year filer with no
(check Item A, box 1)
changes
changes, reporting rebates
changes, not reporting rebates
(check Item A, box 2)
(check Item A, box 3)
(check Item A, box 4)
Page 1
Yes
Yes
Yes
Yes
Schedule A
Yes
No
No
No
Yes, if NDC additions or
Schedule B
No
deletions (1), (2), (3)
No
No
Schedule C
No
Yes, if orphan drug changes (1), (3)
No
No
Schedule D
No
Yes, if reporting rebates (1), (3)
Yes
No
Schedule E
Yes, if Item B, box 2a or 2b,
Yes, if Item B, box 2a or 2b,
Yes, if Item B, box 2a or 2b,
Yes, if Item B, box 2a or 2b,
Schedule E, Line 1
checked
checked
checked
checked
Schedule E, Line 2
Yes
No
No
No
Schedule E, Line 3
Yes
No
No
No
Schedule E, Line 4
No
Yes, if Schedule B attached
No
No
Schedule E, Line 5
No
Yes, if Schedule B attached
No
No
Schedule E, Line 6
No
Yes, if Schedule B attached
No
No
Schedule E, Line 7
No
Yes, if Schedule C attached
No
No
Schedule E, Line 8
No
Yes, if Schedule D attached
Yes
No
Schedule E, Line 9
No
Yes, if Schedule D attached
Yes
No
Part II
Yes
Yes
Yes
Yes
(1) NDCs reported on Schedule B cannot be shown on Schedules C or D.
(2) In Section I, report as additions only NDCs that were not associated with the covered entity for the previous sales year.
(3) On Schedule B, (Section II), Schedule C, or Schedule D, report only NDCs that were associated with the covered entity for the previous sales year.

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