spending threshold) for identifying (and shall identify) low cost drugs to be excluded from the definition of the term applicable drug , such as a drug that has a wholesale acquisition cost of less than $10 per unit or less than $100 in average estimated expenditures under title XVIII per individual per year or per user of such drug per year. For purposes of this section, a drug shall not be considered specified as a low cost drug for a lookback period described in subsection (b)(1) with respect to a year unless such drug is identified as being below the specified threshold for the entirety of the lookback period. (2) Manufacturer The term manufacturer has the meaning given that term in section 1847A(c)(6)(A). (3) Wholesale acquisition cost The term wholesale acquisition cost has the meaning given that term in section 1847A(c)(6)(B). . (b) Reporting to the Secretary of the Treasury (1) In general Subpart A of part III of subchapter A of chapter 61 of the Internal Revenue Code of 1986 is amended by inserting after section 6039J the following new section: 6039K. Drug price SPIKE increase reporting Each manufacturer (within the meaning of section 1128L of the Social Security Act) shall file a return (as such time and in such form and manner as the Secretary may provide) showing for each year with respect to which such section applies all information and supporting documentation and the certification included within a justification reported by the manufacturer under subsection (c)(1) of such section. . (2) Clerical amendment The table of sections for subpart A of part III of subchapter A of chapter 61 of such Code is amended by inserting after the item relating to section 6039J the following new item: Sec. 6039K. Drug price SPIKE increase reporting. . 3. Requirement for manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers (a) In general Section 1128G(a) of the Social Security Act (42 U.S.C. 1320a–7h(a)) is amended by adding