25.21.1  Branded Prescription Drug Fee

Manual Transmittal

July 27, 2012

Purpose

(1) This transmits revised IRM 25.21.1, Affordable Care Act Fees, Branded Prescription Drug Fee. This IRM section provides an awareness and understanding of the Branded Prescription Drug Fee process.

Material Changes

(1) Subsection 25.21.1.10 is revised to state that if the final fee payment due date falls on a non-business day, the final fee will be due on the following business day.

Effect on Other Documents

IRM 25.21.1 dated March 28, 2012 is superseded.

Audience

Frontline employees from all operating divisions and functions that may receive BPD inquiries.

Effective Date

(07-27-2012)

Sunita Lough
Acting Director, Pre-Filing and Technical Guidance
Large Business and International Division

25.21.1.1  (03-28-2012)
Overview

  1. This IRM section provides information to employees about the Branded Prescription Drug ("BPD" ) Fee imposed by section 9008 of the Affordable Care Act. This provision of the ACA did not amend the Internal Revenue Code.

  2. Section 9008 of the Affordable Care Act of 2010 imposes a fee on covered entities engaged in the business of manufacturing or importing BPDs for sale to any specified government program or pursuant to coverage under any such program for each calendar year beginning after 2010.

  3. A covered entity is any manufacturer or importer with gross receipts from BPD sales.

  4. Section 9008 (b)(4) sets an applicable fee each year that will be apportioned among covered entities with BPDs of over $5 million to government programs or pursuant to coverage under such programs. The applicable fee amounts for calendar years are:

    Year Fee Amount
    2011 $2.5 billion
    2012 $2.8 billion
    2013 $2.8 billion
    2014 $3.0 billion
    2015 $3.0 billion
    2016 $3.0 billion
    2017 $4.0 billion
    2018 $4.1 billion
    2019 and thereafter $2.8 billion

  5. BPD fees collected under the provision are credited to the Medicare Part B trust fund.

  6. Exhibit 25.21.1-1 provides a high level overview of the BPD fee process

  7. A Section 9008 team is designated to administer the BPD fee. BPD Inquiries or questions may be directed to the team at their dedicated phone number, 1-908-301-2118 (not a toll-free number).

25.21.1.1.1  (03-28-2012)
Branded Prescription Drug Fee Guidance

  1. The IRS has issued guidance on the BPD fee as follows:

    • Notice 2010-71 (modified and superseded by Notice 2011-9)

    • Notice 2011-9 (modified by Notice 2011-46)

    • Notice 2011-46

    • Rev. Proc. 2011-24 (modified by Notice 2011-46 and obsoleted by Notice 2011-92)

    • 26 CFR Part 51, TD 9544, August 18, 2011 (2011-40 IRB 458)

    • Notice 2011-92

25.21.1.2  (03-28-2012)
Information Requested from Covered Entities

  1. Covered entities may provide information relevant to the determination of the BPD fee by submitting Form 8947,Report of Prescription Drug Information, and providing the information specified by the form and instruction.

  2. Information requested on Form 8947 includes:

    • National Drug Code ("NDC" ) for branded prescription drugs that the covered entity sold to the specified government programs,

    • Medicare and Medicaid state rebate information,

    • Section 45C orphan drug information,

    • Members of controlled groups, if applicable, and

    • Designated entity information.

  3. Covered entities that choose to file must submit Form 8947 by a date set by guidance published in the IRB. For the 2012 fee year, the date is December 15, 2011.

    Dept. of Treasury
    Internal Revenue Service
    1973 N Rulon White Boulevard
    Mail Stop 4916
    Ogden, UT 84404

25.21.1.3  (03-28-2012)
Data Transcription and Due Diligence

  1. All Form 8947 data received are transcribed onto the BPD application system.

  2. Data perfection is performed as necessary to perfect data in the system.

  3. Due diligence is performed to determine proper NDC, orphan drugs, and rebates reported.

25.21.1.4  (03-28-2012)
Information Requested from the Agencies

  1. A list of BPDs by NDC will be compiled from all transcribed Forms 8947.

  2. The list along with a request for sales data by NDC and by program will be forwarded to the contact person for each of these agencies:

    • Centers for Medicaid and Medicare Services of the Department of Health and Human Services will determine BPD sales under the Medicare Part D, Medicare Part B, and Medicaid programs.

    • The Department of Veteran Affairs will provide BPD procured under the VA program.

    • The Department of Defense will provide BPD procured under the DOD program and the TRICARE retail pharmacy program.

  3. All sales data from agencies are input into the BPD Application System by NDC and by covered entities.

25.21.1.5  (03-28-2012)
Fee Calculation

  1. The annual applicable amount is apportioned to each covered entity based on the ratio between a covered entity’s BPD sales taken into account during the sales year and the aggregate BPD sales taken into account during the sales year for all covered entities. The sales year is defined as the second calendar year preceding the fee year. For example, for the fee year of 2011, the sales year is 2009. The fee year is the calendar year in which the fee for a particular sales year must be paid to the government.

  2. BPD sales are sales of BPDs to any government program (Medicare Part B, Medicare Part D, Medicaid, any program under which BPDs are procured by the Department of Veterans Affairs, any program under which BPDs are procured by the Department of Defense and the TRICARE retail pharmacy program). BPD sales do not include orphan drug sales.

  3. A covered entity’s BPD sales taken into account during the calendar year are as follows:

    BPD Sales Percentage
    Not more than $5M 0%
    More than $5M but not more than $125M 10%
    More than $125M but not more than $225M 40%
    More than $225M but not more than $400M 75%
    More than $400M 100%

25.21.1.6  (03-28-2012)
Adjustment Methodology

  1. In addition to the allocated fee for the fee year, there will also be an adjustment calculation starting for each fee year after 2011.

  2. The adjustment calculation reflects the difference between:

    • The allocated fee for the immediate preceding fee year as originally determined using sales data from the second preceding calendar year preceding the fee year, and

    • The allocated fee for the immediate preceding fee year determined using sales data from the calendar year immediately preceding the fee year.

25.21.1.7  (03-28-2012)
Notice of Preliminary Calculation (Letter 4657)

  1. For each sales year, the IRS will notify a covered entity of its preliminary fee calculation.

  2. The notification will include the following:

    • The covered entity’s allocated fee,

    • The covered entity’s BPD sales, by NDC and by program,

    • The covered entity’s BPD sales taken into account,

    • The aggregate BPD sales taken into account for all covered entities,

    • The adjustment amount, and

    • A reference to the fee dispute resolution process published in the IRB.

25.21.1.8  (03-28-2012)
Dispute Resolution Process

  1. Upon receipt of the preliminary fee calculation, each covered entity will have an opportunity within a specified time period to dispute the calculation by submitting an error report. There are two types of errors:

    • Program drug sales data errors, and

    • Errors other than program drug sales data errors

25.21.1.8.1  (03-28-2012)
Program Drug Sales Data Errors

  1. The covered entity must submit a separate error report for each program with its asserted errors. Each error report for program errors must include:

    • Entity name, entity number from Part I (a) of Form 8947, and EIN

    • A contact name and number

      Note:

      Form 2848, Power of Attorney and Declaration of Representative, must be filed with the error report. See also 26 CFR § 51.7T (b)(2).

    • Name of the program that reported the data, the NDC, the specific amount of sales data disputed, the proposed corrected amount, an explanation, and documentation to establish the existence of an error.

25.21.1.8.2  (03-28-2012)
Errors Other than Program Drug Sales Errors

  1. All error reports for errors other than program drug sales errors must include:

    • Entity name, entity number from Part I (a) of Form 8947, and EIN

    • A contact name and number.

      Note:

      If the contact is not an employee of the entity, Form 2848, Power of Attorney and Declaration of Representative, must be filed with the error report. See also 26 CFR § 51.7T (c)(2).

  2. For a mathematical calculation error, the error report must identify the specific calculation element(s) the entity disputes and its proposed corrected calculation.

  3. For a rebate data error, the error report must include:

    • The NDC for the drug to which it relates,

    • A discussion on whether data used in the preliminary fee calculation matches previously reported Form 8947 data on rebates, and

    • If data used in the preliminary fee calculation matches previously reported Form 8947, an explanation of why the Form 8947 data was erroneous and why the IRS should use the proposed corrected data instead.

  4. For an error in the listing of an NDC for an orphan drug, the error report must include:

    • The name and NDC of the orphan drug,

    • A discussion of whether data used in the preliminary fee calculation matches previously reported Form 8947 data on orphan drugs, and

    • If data used in the preliminary fee calculation matches the Form 8947 data, an explanation of why the Form 8947 was erroneous and why the IRS should use the proposed corrected data instead.

  5. For any other asserted errors not previously described, the report must contain:

    • an explanation of the nature of the error,

    • how the error affects the fee calculation,

    • an explanation of how the entity established that an error occurred,

    • the proposed correction to the error, and

    • an explanation of why the IRS or agency should use the proposed corrected data instead. See IRM 25.21.1.4 for a list of the agencies.

25.21.1.8.3  (03-28-2012)
Receipt and Disposition of Error Reports

  1. Covered entities must submit error reports to the following designated address:

    Dept. of Treasury
    Internal Revenue Service
    1973 N Rulon White Boulevard
    Mail Stop 4916
    Ogden, UT 84404

  2. Upon receipt of error reports:

    • Disputes for program errors are forwarded to the agencies for review and consideration.

    • The IRS will review and consider disputes for all other errors.

  3. Any changes made pursuant to the dispute resolution process will be reflected in the final fee calculation.

25.21.1.9  (03-28-2012)
Notification of Final Fee Calculation (Letter 4658)

  1. The final fee calculation for a fee year will be sent to each covered entity no later than August 31st of each fee year.

  2. The final fee calculation will be based on the preliminary fee calculation as adjusted pursuant to the dispute resolution process.

  3. A covered entity’s final fee may differ from the covered entity’s preliminary fee calculation because of changes made pursuant to the dispute resolution process.

25.21.1.10  (07-27-2012)
Payment of Fee

  1. Each covered entity must pay its final fee by September 30th of the fee year. If the due date for payment falls on a Saturday, Sunday, or legal holiday, the fee may be paid on the next business day. The term "legal holiday" means any legal holiday in the District of Colombia. For a list of legal holidays, go to IRS.gov and enter the words "legal holidays" in the search box.

  2. The fee must be paid by electronic funds transfer.

  3. For a controlled group, the payment must be made using the designated entity’s EIN as reported on Form 8947. All covered entities within a controlled group are jointly and severally liable for the fee.

25.21.1.11  (03-28-2012)
Fee is Not Deductible

  1. Section 9008 (f) (2) of the ACA provides that for purposes of Section 275 of the IRC the BPD fee shall be considered to be a tax described in Section 275 (a) (6).

25.21.1.12  (03-28-2012)
Refund Claims

  1. A claim for refund of the fee must be made by the entity that paid the fee.

  2. The claim must be made on Form 843, Claim for Refund and Request for Abatement.

  3. A claim for refund of the fee cannot be processed and must be routed to the following designated address for special handling:

    Dept. of Treasury
    Internal Revenue Service
    1973 N Rulon White Boulevard
    Mail Stop 4916
    Ogden, UT 84404

Exhibit 25.21.1-1 
BPD Fee Process Flowchart

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