Section 9009

SEC. 9009. IMPOSITION OF ANNUAL FEE ON MEDICAL DEVICE MANUFACTURERS AND IMPORTERS.

[a] Imposition of Fee-

[1] IN GENERAL- Each covered entity engaged in the business of manufacturing or importing medical devices shall pay to the Secretary not later than the annual payment date of each calendar year beginning after 2009 a fee in an amount determined under subsection [b].

[2] ANNUAL PAYMENT DATE- For purposes of this section, the term 'annual payment date' means with respect to any calendar year the date determined by the Secretary, but in no event later than September 30 of such calendar year.

[b] Determination of Fee Amount-

[1] IN GENERAL- With respect to each covered entity, the fee under this section for any calendar year shall be equal to an amount that bears the same ratio to $2,000,000,000 as--

[A] the covered entity's gross receipts from medical device sales taken into account during the preceding calendar year, bear to

[B] the aggregate gross receipts of all covered entities from medical device sales taken into account during such preceding calendar year.

[2] GROSS RECEIPTS FROM SALES TAKEN INTO ACCOUNT- For purposes of paragraph [1], the gross receipts from medical device sales taken into account during any calendar year with respect to any covered entity shall be determined in accordance with the following table:

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- With respect to a covered entity's aggregate gross receipts from medical device sales during the calendar year that are: The percentage of gross receipts taken into account is: --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Not more than $5,000,000 0 percent More than $5,000,000 but not more than $25,000,000 50 percent More than $25,000,000 100 percent. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[3] SECRETARIAL DETERMINATION- The Secretary shall calculate the amount of each covered entity's fee for any calendar year under paragraph [1]. In calculating such amount, the Secretary shall determine such covered entity's gross receipts from medical device sales on the basis of reports submitted by the covered entity under subsection [f] and through the use of any other source of information available to the Secretary.

[c] Covered Entity-

[1] IN GENERAL- For purposes of this section, the term 'covered entity' means any manufacturer or importer with gross receipts from medical device sales.

[2] CONTROLLED GROUPS-

[A] IN GENERAL- For purposes of this subsection, all persons treated as a single employer under subsection [a] or [b] of section 52 of the Internal Revenue Code of 1986 or subsection [m] or [o] of section 414 of such Code shall be treated as a single covered entity.

[B] INCLUSION OF FOREIGN CORPORATIONS- For purposes of subparagraph [A], in applying subsections [a] and [b] of section 52 of such Code to this section, section 1563 of such Code shall be applied without regard to subsection [b][2][C] thereof.

[d] Medical Device Sales- For purposes of this section--

[1] IN GENERAL- The term 'medical device sales' means sales for use in the United States of any medical device, other than the sales of a medical device that--

[A] has been classified in class II under section 513 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c] and is primarily sold to consumers at retail for not more than $100 per unit, or

[B] has been classified in class I under such section.

[2] UNITED STATES- For purposes of paragraph [1], the term 'United States' means the several States, the District of Columbia, the Commonwealth of Puerto Rico, and the possessions of the United States.

[3] MEDICAL DEVICE- For purposes of paragraph [1], the term 'medical device' means any device [as defined in section 201[h] of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321[h]]] intended for humans.

[e] Tax Treatment of Fees- The fees imposed by this section--

[1] for purposes of subtitle F of the Internal Revenue Code of 1986, shall be treated as excise taxes with respect to which only civil actions for refund under procedures of such subtitle shall apply, and

[2] for purposes of section 275 of such Code, shall be considered to be a tax described in section 275[a][6].

[f] Reporting Requirement-

[1] IN GENERAL- Not later than the date determined by the Secretary following the end of any calendar year, each covered entity shall report to the Secretary, in such manner as the Secretary prescribes, the gross receipts from medical device sales of such covered entity during such calendar year.

[2] PENALTY FOR FAILURE TO REPORT-

[A] IN GENERAL- In the case of any failure to make a report containing the information required by paragraph [1] on the date prescribed therefor [determined with regard to any extension of time for filing], unless it is shown that such failure is due to reasonable cause, there shall be paid by the covered entity failing to file such report, an amount equal to--

[i] $10,000, plus

[ii] the lesser of--

[I] an amount equal to $1,000, multiplied by the number of days during which such failure continues, or

[II] the amount of the fee imposed by this section for which such report was required.

[B] TREATMENT OF PENALTY- The penalty imposed under subparagraph [A]--

[i] shall be treated as a penalty for purposes of subtitle F of the Internal Revenue Code of 1986,

[ii] shall be paid on notice and demand by the Secretary and in the same manner as tax under such Code, and

[iii] with respect to which only civil actions for refund under procedures of such subtitle F shall apply.

[g] Secretary- For purposes of this section, the term 'Secretary' means the Secretary of the Treasury or the Secretary's delegate.

[h] Guidance- The Secretary shall publish guidance necessary to carry out the purposes of this section, including identification of medical devices described in subsection [d][1][A] and with respect to the treatment of gross receipts from sales of medical devices to another covered entity or to another entity by reason of the application of subsection [c][2].

[i] Application of Section- This section shall apply to any medical device sales after December 31, 2008.