[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2029 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 2029

      To amend title XI of the Social Security Act to provide for 
 transparency in the relationship between physicians and manufacturers 
of drugs, devices, or medical supplies for which payment is made under 
                     Medicare, Medicaid, or SCHIP.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 6, 2007

 Mr. Grassley (for himself, Mr. Kohl, Mr. Kennedy, Mrs. McCaskill, Mr. 
 Schumer, and Ms. Klobuchar) introduced the following bill; which was 
          read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
      To amend title XI of the Social Security Act to provide for 
 transparency in the relationship between physicians and manufacturers 
of drugs, devices, or medical supplies for which payment is made under 
                     Medicare, Medicaid, or SCHIP.

    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 ``Physician Payments Sunshine Act of 
2007''.

SEC. 2. QUARTERLY TRANSPARENCY REPORTS FROM MANUFACTURERS OF COVERED 
              DRUGS, DEVICES, OR MEDICAL SUPPLIES UNDER MEDICARE, 
              MEDICAID, OR SCHIP.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.) is amended by inserting after section 1128F the following new 
section:

``SEC. 1128G. QUARTERLY TRANSPARENCY REPORTS FROM MANUFACTURERS OF 
              COVERED DRUGS, DEVICES, OR MEDICAL SUPPLIES UNDER 
              MEDICARE, MEDICAID, OR SCHIP.

    ``(a) Reporting of Payments or Other Transfer of Value.--On January 
1, 2008, and the first day of each fiscal year quarter beginning 
thereafter, each manufacturer of a covered drug, device, or medical 
supply who provides a payment or other transfer of value, directly, 
indirectly, or through an agent, subsidiary, or other third party, to a 
physician, or to an entity that a physician is employed by, has tenure 
with, or has an ownership interest in, shall submit to the Secretary, 
in such electronic form as the Secretary shall require, the following:
            ``(1) The name of the physician, and if a payment or other 
        transfer of value was provided to an entity that the physician 
        is employed by, has tenure with, or has an ownership interest 
        in, the entity.
            ``(2) The address of--
                    ``(A) the physician's office; and
                    ``(B) in the case of an entity required to be named 
                under paragraph (1), the primary place of business or 
                headquarters for the entity.
            ``(3) The facility with which the physician is affiliated, 
        if any.
            ``(4) The value of the payment or other transfer of value.
            ``(5) The date on which the payment or other transfer of 
        value was provided.
            ``(6) A description of the nature of the payment or other 
        transfer of value, indicated (as appropriate for all that 
        apply) as--
                    ``(A) compensation;
                    ``(B) food, entertainment, or gifts;
                    ``(C) trips or travel;
                    ``(D) a product or other item provided for less 
                than market value;
                    ``(E) participation in a medical conference, 
                continuing medical education, or other educational or 
                informational program or seminar, provision of 
                materials related to such a conference or educational 
                or informational program or seminar, or remuneration 
                for promoting or participating in such a conference or 
                educational or informational program or seminar;
                    ``(F) product rebates or discounts;
                    ``(G) consulting fees or honoraria; or
                    ``(H) any other economic benefit, as defined by the 
                Secretary.
            ``(7) The medical issue or condition addressed, if any, 
        that was the basis for the payment or transfer.
    ``(b) Annual Summary Report.--Each manufacturer of a covered drug, 
device, or medical supply that is required to submit information under 
subsection (a) during a year shall submit a report to the Secretary not 
later than December 31 of the year that summarizes, in such electronic 
form as the Secretary shall specify, each submission of information 
under subsection (a) made by the manufacturer during the year.
    ``(c) Penalty for Noncompliance.--Any manufacturer of a covered 
drug, device, or medical supply that fails to submit information 
required under subsection (a) or (b) in accordance with regulations 
promulgated to carry out such subsection, shall be subject to a civil 
money penalty of not less than $10,000, but not more than $100,000, for 
each such failure. Such penalty 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.
    ``(d) Public Availability.--Not later than June 1, 2008, the 
Secretary shall establish procedures to ensure that the information 
reported under subsection (a) and the summary reports submitted under 
subsection (b) are readily accessible to the public through an Internet 
website that is easily searchable, downloadable, and understandable.
    ``(e) Report to Congress.--Not later than April 1 of each year 
beginning with 2009, the Secretary shall submit to Congress a report 
that includes the following:
            ``(1) The information submitted under subsections (a) and 
        (b) during the preceding year, aggregated for each manufacturer 
        of a covered drug, device, or medical supply that submitted 
        such information during such year.
            ``(2) A description of any enforcement actions taken to 
        carry out this section, including any penalties imposed under 
        subsection (c), during the preceding year.
    ``(f) Definitions.--In this section:
            ``(1) Covered drug, device, or medical supply.--The term 
        `covered drug, device, or medical supply' means any drug, 
        biological product, device, or medical supply for which payment 
        is available under title XVIII or a State plan under title XIX 
        or XXI (or a waiver of such a plan).
            ``(2) Manufacturer of a covered drug, device, or medical 
        supply.--The term `manufacturer of a covered drug, device, or 
        medical supply' means any entity with annual gross revenues 
        that exceed $100,000,000, which is engaged in--
                    ``(A) the production, preparation, propagation, 
                compounding, conversion, or processing of a covered 
                drug, device, or medical supply; or
                    ``(B) the packaging, repackaging, labeling, 
                relabeling, or distribution of a covered drug, device, 
                or medical supply.
            ``(3) Payment or other transfer of value.--
                    ``(A) In general.--The term `payment or other 
                transfer of value' means a transfer of anything of 
                value that exceeds $25, and includes any compensation, 
                gift, honorarium, speaking fee, consulting fee, travel, 
                discount, cash rebate, or services.
                    ``(B) Exclusions.--Such term does not include the 
                following:
                            ``(i) Product samples that are intended for 
                        patients.
                            ``(ii) A payment or other transfer of value 
                        made for the general funding of a clinical 
                        trial.
                            ``(iii) A transfer of anything of value to 
                        a physician when the physician is a patient and 
                        not acting in his or her professional capacity.
            ``(4) Physician.--The term `physician' has the meaning 
        given that term in section 1861(r).''.
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