[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2221 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 2221

  To amend title XVIII of the Social Security Act to provide for the 
     reporting of sales price data for implantable medical devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 23, 2007

  Mr. Grassley (for himself and Mr. Specter) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To amend title XVIII of the Social Security Act to provide for the 
     reporting of sales price data for implantable medical devices.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Transparency in Medical Device 
Pricing Act of 2007''.

SEC. 2. REPORTING OF SALES PRICE DATA FOR IMPLANTABLE MEDICAL DEVICES.

    Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is 
amended by adding at the end the following new section:

``SEC. 1898. REPORTING OF SALES PRICE DATA FOR IMPLANTABLE MEDICAL 
              DEVICES.

    ``(a) Collection of Sales Price Data.--
            ``(1) Quarterly reports from manufacturers of covered 
        medical devices.--Not later than the date that is 30 days after 
        the last day of each fiscal year quarter beginning on or after 
        January 1, 2009, in the case of a covered medical device that 
        is used in a procedure identified under subsection (b), each 
        manufacturer of such device shall submit to the Secretary, in 
        such form as the Secretary shall require, the following:
                    ``(A) The name of the manufacturer of the covered 
                medical device.
                    ``(B) The name of the covered medical device.
                    ``(C) The category type of the covered medical 
                device (using a nomenclature specified by the Secretary 
                for categorizing medical devices in order to ensure 
                consistent reporting).
                    ``(D) The hospital inpatient procedure or hospital 
                outpatient procedure identified under subsection (b) 
                with respect to which the medical device was used 
                during the quarter.
                    ``(E) The average and median sales price of the 
                covered medical device.
                    ``(F) Such other information as the Secretary 
                requires, including the unit of measure used to 
                determine the number of medical devices sold by the 
                manufacturer.
            ``(2) Penalties for noncompliance.--
                    ``(A) Failure to submit information.--Any 
                manufacturer of a covered medical device that fails to 
                submit information required under paragraph (1) in 
                accordance with regulations promulgated to carry out 
                such paragraph, shall be subject to a civil money 
                penalty of not less than $10,000, but not more than 
                $100,000, for each such failure.
                    ``(B) Misrepresentation.--Any manufacturer of a 
                covered medical device that misrepresents the average 
                or median sales price of such device in information 
                submitted under paragraph (1) shall be subject to a 
                civil money penalty of not less than $10,000, but not 
                more than $100,000, for each such misrepresentation and 
                for each day in which such misrepresented average or 
                median sales price is made publicly available under 
                subsection (c).
                    ``(C) Imposition and collection.--A penalty under 
                subparagraph (A) or (B) shall be imposed and collected 
                in the same manner as civil money penalties under 
                subsection (a) of section 1128A are imposed and 
                collected under that section.
            ``(3) Definitions.--In this section:
                    ``(A) Average sales price.--
                            ``(i) In general.--Subject to clauses (ii) 
                        and (iii), the term `average sales price' 
                        means, of a covered medical device for a fiscal 
                        year quarter for a manufacturer for a unit--
                                    ``(I) the manufacturer's sales to 
                                all purchasers (excluding sales 
                                exempted in clause (ii)) in the United 
                                States for such covered medical device 
                                in the quarter; divided by
                                    ``(II) the total number of such 
                                units of such covered medical device 
                                sold by the manufacturer in such 
                                quarter.
                            ``(ii) Certain sales exempted from 
                        computation.--In calculating the manufacturer's 
                        average sales price under this subparagraph, 
                        certain sales may be excluded in the case where 
                        the Secretary determines such exclusion is 
                        appropriate.
                            ``(iii) Sale price net of discounts.--In 
                        calculating the manufacturer's average sales 
                        price under this subparagraph, such price shall 
                        include volume discounts, cash discounts, free 
                        goods and services that are contingent on any 
                        purchase requirement, chargebacks, and rebates, 
                        and any other discounts or price concessions 
                        the Secretary determines to be appropriate 
                        (using a methodology developed by the Secretary 
                        to estimate costs during the quarter that are 
                        attributable to discounts and price 
                        concessions).
                    ``(B) Covered medical device.--The term `covered 
                medical device' means any device for which payment is 
                available under title XVIII or a State plan under title 
                XIX or XXI (or a waiver of such a plan).
                    ``(C) Median sales price.--
                            ``(i) In general.--Subject to clauses (ii) 
                        and (iii), the term `median sales price' means, 
                        of a covered medical device for a fiscal year 
                        quarter for a manufacturer for a unit, the 
                        median of all sales by the manufacturer to 
                        purchasers (excluding sales exempted in clause 
                        (ii)) in the United States for such covered 
                        medical device in the quarter.
                            ``(ii) Certain sales exempted from 
                        computation.--In calculating the manufacturer's 
                        median sales price under this subparagraph, 
                        certain sales may be excluded in the case where 
                        the Secretary determines such exclusion is 
                        appropriate.
                            ``(iii) Sale price net of discounts.--In 
                        calculating the manufacturer's median sales 
                        price under this subparagraph, such price shall 
                        include volume discounts, cash discounts, free 
                        goods and services that are contingent on any 
                        purchase requirement, chargebacks, and rebates, 
                        and any other discounts or price concessions 
                        the Secretary determines to be appropriate 
                        (using a methodology developed by the Secretary 
                        to estimate costs during the quarter that are 
                        attributable to discounts and price 
                        concessions).
    ``(b) Identification of Procedures.--For purposes of subsection 
(a), the Secretary shall identify--
            ``(1) all hospital inpatient procedures for which payment 
        is provided under section 1886(d) that involve the implantation 
        of a medical device; and
            ``(2) all hospital outpatient procedures for which payment 
        is provided under section 1833(t) that involve the implantation 
        of a medical device.
    ``(c) Public Availability.--Not later than April 30, 2009, the 
Secretary shall establish procedures to ensure that the information 
reported under subsection (a) is readily accessible to the public 
through the Internet website of the Centers for Medicare & Medicaid 
Services in a manner that is easily searchable, downloadable, and 
understandable. Such procedures shall ensure that the website is 
updated each quarter as new information is reported under such 
subsection.''.
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