I
116th CONGRESS
1st Session
H. R. 2087
IN THE HOUSE OF REPRESENTATIVES
April 4, 2019
Mr. Doggett (for himself and Mr. Buchanan) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes.
Short title
This Act may be cited as the Drug Price Transparency Act
.
Requiring certain manufacturers to report drug pricing information with respect to drugs under the Medicare program
In general
Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended—
in subsection (b)—
in paragraph (2)(A), by inserting or subsection (f)(2), as applicable
before the period at the end;
in paragraph (3), in the matter preceding subparagraph (A), by inserting or subsection (f)(2), as applicable,
before determined by
; and
in paragraph (6)(A), in the matter preceding clause (i), by inserting or subsection (f)(2), as applicable,
before determined by
; and
in subsection (f)—
by striking For requirements
and inserting the following:
In general
For requirements
; and
by adding at the end the following new paragraph:
Manufacturers without a rebate agreement under title XIX
In general
In the case of a manufacturer of a drug or biological described in subparagraph (C), (E), or (G) of section 1842(o)(1) or in clause (ii) or (iii) of section 1881(b)(14)(B) that does not have a rebate agreement in effect under section 1927, for calendar quarters beginning on or after January 1, 2020, 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.
Audit
Information reported under subparagraph (A) is subject to audit by the Inspector General of the Department of Health and Human Services.
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).
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—
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;
to permit the Comptroller General to review the information provided; and
to permit the Director of the Congressional Budget Office to review the information provided.
.
Enforcement
In general
Section 1847A such Act (42 U.S.C. 1395w–3a) is further amended—
in subsection (d)(4)—
in subparagraph (A), by striking In general
and inserting Misrepresentation
;
in subparagraph (B), by striking subparagraph (B)
and inserting subparagraph (A), (B), or (C)
;
by redesignating subparagraph (B) as subparagraph (D); and
by inserting after subparagraph (A) the following new subparagraphs:
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 $25,000 for each day the manufacturer has failed to report such information and such amount shall be paid to the Treasury.
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.
; and
in subsection (c)(6)(A), by striking the period at the end and inserting , except that, for purposes of subsection (f)(2), the Secretary may, if the Secretary determines appropriate, exclude repackagers of a drug or biological from such term.
.
Conforming existing manufacturer reporting penalties
Section 1927(b)(3)(C)(i) of such Act (42 U.S.C. 1396r–8(b)(3)(C)(i)) is amended by inserting (or, for such failures occurring on or after January 1, 2020, $25,000)
after $10,000
.
Report
Not later than January 1, 2021, the Inspector General of the Department of Health and Human Services shall assess and submit to Congress a report on the accuracy of average sales price information submitted by manufacturers under section 1847A of the Social Security Act (42 U.S.C. 1395w–3a). Such report shall include any recommendations on how to improve the accuracy of such information.