H.R. 1570 — what changed
Removing Barriers to Colorectal Cancer Screening Act of 2020
From Introduced in House to Engrossed in House. 3 sections amended and 1 added between Introduced in House and Engrossed in House.
Section 1 Short title
changed
This Act may be cited as the “Removing Barriers to Colorectal Cancer Screening Act of 2019”.2020”.
Sec. 2 Waiving medicare coinsurance for certain colorectal cancer screening tests
removed
Congress finds the following:
added “(dd) Special coinsurance rule for certain colorectal cancer screening tests
added “(1) In general—In the case of a colorectal cancer screening test to which paragraph (1)(Y) of subsection (a) would not apply but for the third sentence of such subsection that is furnished during a year beginning on or after January 1, 2022, and before January 1, 2030, the amount paid shall be equal to the specified percent (as defined in paragraph (2)) for such year of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such test under this part (or, in the case such test is a covered OPD service (as defined in subsection (t)(1)(B)), the amount determined under subsection (t)).
added “(2) Specified percent defined—For purposes of paragraph (1), the term “specified percent” means—
added “(A) for 2022 and 2023, 80 percent;
added “(B) for 2024 and 2025, 85 percent;
added “(C) for 2026 and 2027, 90 percent; and
added “(D) for 2028 and 2029, 95 percent.”
Sec. 3 Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program
added “(1) In general—For requirements”
added “(2) Manufacturers without a rebate agreement under title XIX
added “(A) In general—If the manufacturer of a drug or biological described in subparagraph (C), (E), or (G) of section 1842(o)(1) or in section 1881(b)(14)(B) that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection (b) of section 1927, for calendar quarters beginning with the second calendar quarter beginning on or after the date of the enactment of this paragraph, such manufacturer shall report to the Secretary the information described in subsection (b)(3)(A)(iii) of such section 1927 with respect to such drug or biological in a time and manner specified by the Secretary. For purposes of applying this paragraph, a drug or biological described in the previous sentence includes items, services, supplies, and products that are payable under this part as a drug or biological.
added “(B) Audit—Information reported under subparagraph (A) is subject to audit by the Inspector General of the Department of Health and Human Services.
added “(C) Verification—The Secretary may survey wholesalers and manufacturers that directly distribute drugs described in subparagraph (A), when necessary, to verify manufacturer prices and manufacturer’s average sales prices (including wholesale acquisition cost) if required to make payment reported under subparagraph (A). The Secretary may impose a civil monetary penalty in an amount not to exceed $100,000 on a wholesaler, manufacturer, or direct seller, if the wholesaler, manufacturer, or direct seller of such a drug refuses a request for information about charges or prices by the Secretary in connection with a survey under this subparagraph or knowingly provides false information. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).
added “(D) Confidentiality—Notwithstanding any other provision of law, information disclosed by manufacturers or wholesalers under this paragraph (other than the wholesale acquisition cost for purposes of carrying out this section) is confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler, except—
added “(i) as the Secretary determines to be necessary to carry out this section (including the determination and implementation of the payment amount), or to carry out section 1847B;
added “(ii) to permit the Comptroller General of the United States to review the information provided; and
added “(iii) to permit the Director of the Congressional Budget Office to review the information provided.”
added “(B) Failure to provide timely information—If the Secretary determines that a manufacturer described in subsection (f)(2) has failed to report on information described in section 1927(b)(3)(A)(iii) with respect to a drug or biological in accordance with such subsection, the Secretary shall apply a civil money penalty in an amount of $10,000 for each day the manufacturer has failed to report such information and such amount shall be paid to the Treasury.
added “(C) False information—Any manufacturer required to submit information under subsection (f)(2) that knowingly provides false information is subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalties are in addition to other penalties as may be prescribed by law.”
Sec. 4 Determination of budgetary effects
addedadded The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.