Physician Payments Sunshine Act of 2009 - Amends part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers.
Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services.
Requires any such manufacturer, related group purchasing organization, or applicable distributor also to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer, group purchasing organization, or applicable distributor during the preceding year.
Prescribes administrative penalties for failure to comply with these requirements.
Requires report submission procedures to ensure public availability of required information on a website.
[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3138 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 3138
To amend title XI of the Social Security Act to provide for
transparency in the relationship between physicians and manufacturers
of drugs, devices, biologicals, or medical supplies for which payment
is made under Medicare, Medicaid, or SCHIP.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 9, 2009
Mr. Hill 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 XI of the Social Security Act to provide for
transparency in the relationship between physicians and manufacturers
of drugs, devices, biologicals, 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
2009''.
SEC. 2. TRANSPARENCY REPORTS AND REPORTING OF PHYSICIAN OWNERSHIP OR
INVESTMENT INTERESTS.
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. TRANSPARENCY REPORTS AND REPORTING OF PHYSICIAN OWNERSHIP
OR INVESTMENT INTERESTS.
``(a) Transparency Reports.--
``(1) Payments or other transfers of value.--
``(A) In general.--Except as provided in subsection
(e), not later than March 31 of each year (beginning
with 2012), any applicable manufacturer that provides a
payment or other transfer of value to a covered
recipient (or to an entity or individual at the request
of or designated on behalf of a covered recipient),
shall submit to the Secretary, in such electronic form
as the Secretary shall require, the following
information with respect to the preceding calendar
year:
``(i) The name of the covered recipient.
``(ii) The business address of the covered
recipient and, in the case of a covered
recipient who is a physician, the specialty and
National Provider Identifier of the covered
recipient.
``(iii) The value of the payment or other
transfer of value.
``(iv) The dates on which the payment or
other transfer of value was provided to the
covered recipient.
``(v) A description of the form of the
payment or other transfer of value, indicated
(as appropriate for all that apply) as--
``(I) cash or a cash equivalent;
``(II) in-kind items or services;
``(III) stock, a stock option, or
any other ownership interest, dividend,
profit, or other return on investment;
or
``(IV) any other form of payment or
other transfer of value (as defined by
the Secretary).
``(vi) A description of the nature of the
payment or other transfer of value, indicated
(as appropriate for all that apply) as--
``(I) consulting fees;
``(II) compensation for services
other than consulting;
``(III) honoraria;
``(IV) gift;
``(V) entertainment;
``(VI) food;
``(VII) travel;
``(VIII) education;
``(IX) research;
``(X) charitable contribution;
``(XI) royalty or license;
``(XII) current or prospective
ownership or investment interest;
``(XIII) compensation for serving
as faculty or as a speaker for a
continuing medical education program;
``(XIV) grant; or
``(XV) any other nature of the
payment or other transfer of value (as
defined by the Secretary).
``(vii) If the payment or other transfer of
value is related to marketing, education, or
research specific to a covered drug, device,
biological, or medical supply, the name of that
covered drug, device, biological, or medical
supply.
``(viii) Any other categories of
information regarding the payment or other
transfer of value the Secretary determines
appropriate.
Such reports may be submitted at the holding company or
divisional level at the manufacturer's discretion.
``(B) Aggregate reporting.--Information submitted
by an applicable manufacturer under subparagraph (A)
shall include the aggregate amount of all payments or
other transfers of value provided by the applicable
manufacturer to covered recipients (and to entities or
individuals at the request of or designated on behalf
of a covered recipient) during the preceding year.
``(C) Special rule for certain payments or other
transfers of value.--In the case where an applicable
manufacturer provides a payment or other transfer of
value to an entity or individual at the request of or
designated on behalf of a covered recipient, the
applicable manufacturer shall disclose that payment or
other transfer of value under the name of the covered
recipient.
``(2) Physician ownership.--In addition to the requirement
under paragraph (1)(A), not later than March 31 of each year
(beginning with 2012) any applicable manufacturer, applicable
group purchasing organization, or applicable distributor shall
submit to the Secretary, in such electronic form as the
Secretary shall require, the following information regarding
any ownership or investment interest (other than an ownership
or investment interest in a publicly traded security and mutual
fund, as described in section 1877(c)) held by a physician (or
an immediate family member of such physician (as defined for
purposes of section 1877(a))) in the applicable manufacturer,
applicable group purchasing organization or applicable
distributor during the preceding year:
``(A) The dollar amount invested by each physician
holding such an ownership or investment interest.
``(B) The value and terms of each such ownership or
investment interest.
``(C) Any payment or other transfer of value
provided to a physician holding such an ownership or
investment interest (or to an entity or individual at
the request of or designated on behalf of a physician
holding such an ownership or investment interest),
including the information described in clauses (i)
through (viii) of paragraph (1)(A), except that in
applying such clauses, `physician' shall be substituted
for `covered recipient' each place it appears.
``(D) Any other information regarding the ownership
or investment interest the Secretary determines
appropriate.
``(b) Penalties for Noncompliance.--
``(1) Failure to report.--
``(A) In general.--Subject to subparagraph (B),
except as provided in paragraph (2), any applicable
manufacturer, applicable group purchasing organization,
or applicable distributor that fails to submit
information required under subsection (a) in a timely
manner in accordance with rules or regulations
promulgated to carry out such subsection, shall be
subject to a civil money penalty of not less than
$1,000, but not more than $10,000, for each payment or
other transfer of value or ownership or investment
interest not reported as required under such
subsection. 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.
``(B) Limitation.--The total amount of civil money
penalties imposed under subparagraph (A) with respect
to each annual submission of information under
subsection (a) by an applicable manufacturer,
applicable group purchasing organization, or applicable
distributor shall not exceed $150,000.
``(2) Knowing failure to report.--
``(A) In general.--Subject to subparagraph (B), any
applicable manufacturer, applicable group purchasing
organization, or applicable distributor that knowingly
fails to submit information required under subsection
(a) in a timely manner in accordance with rules or
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
payment or other transfer of value or ownership or
investment interest not reported as required under such
subsection. 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.
``(B) Limitation.--The total amount of civil money
penalties imposed under subparagraph (A) with respect
to each annual submission of information under
subsection (a) by an applicable manufacturer,
applicable group purchasing organization, or applicable
distributor shall not exceed $1,000,000.
``(3) Use of funds.--Funds collected by the Secretary as a
result of the imposition of a civil money penalty under this
subsection shall be used to carry out this section.
``(c) Procedures for Submission of Information and Public
Availability.--
``(1) In general.--
``(A) Establishment.--Not later than June 1, 2011,
the Secretary shall establish procedures--
``(i) for applicable manufacturers,
applicable group purchasing organizations, and
applicable distributors to submit information
to the Secretary under subsection (a); and
``(ii) for the Secretary to make such
information submitted available to the public.
``(B) Definition of terms.--The procedures
established under subparagraph (A) shall provide for
the definition of terms (other than those terms defined
in subsection (g)), as appropriate, for purposes of
this section.
``(C) Public availability.--The procedures
established under subparagraph (A)(ii) shall ensure
that, not later than September 30, 2012, and on June 30
of each succeeding calendar year, the information
submitted under subsection (a) with respect to the
preceding calendar year is made available through an
Internet website that--
``(i) is searchable and is in a format that
is clear and understandable;
``(ii) contains information that is
presented by the name of the applicable
manufacturer, applicable group purchasing
organization, or applicable distributor, the
name of the covered recipient, the business
address of the covered recipient, the specialty
of the covered recipient, the value of the
payment or other transfer of value, the date on
which the payment or other transfer of value
was provided to the covered recipient, the form
of the payment or other transfer of value,
indicated (as appropriate) under subsection
(a)(1)(A)(v), the nature of the payment or
other transfer of value, indicated (as
appropriate) under subsection (a)(1)(A)(vi),
and the name of the covered drug, device,
biological, or medical supply, as applicable;
``(iii) contains information that is able
to be easily aggregated and downloaded;
``(iv) contains a description of any
enforcement actions taken to carry out this
section, including any penalties imposed under
subsection (b), during the preceding year;
``(v) contains background information on
industry-physician relationships;
``(vi) in the case of information submitted
with respect to a payment or other transfer of
value described in subsection (e), lists such
information separately from the other
information submitted under subsection (a) and
designates such separately listed information
as funding for clinical research;
``(vii) contains any other information the
Secretary determines would be helpful to the
average consumer; and
``(viii) provides the covered recipient an
opportunity to submit corrections to the
information made available to the public with
respect to the covered recipient.
``(2) Consultation.--In establishing the procedures under
paragraph (1), the Secretary shall consult with the Inspector
General of the Department of Health and Human Services,
affected industry, consumers, consumer advocates, and other
interested parties in order to ensure that the information made
available to the public under such paragraph is presented in
the appropriate overall context.
``(d) Annual Reports and Relation to State Laws.--
``(1) Annual report to congress.--Not later than April 1 of
each year beginning with 2012, the Secretary shall submit to
Congress a report that includes the following:
``(A) The information submitted under subsection
(a) during the preceding year, aggregated for each
applicable manufacturer and applicable group purchasing
organization that submitted such information during
such year.
``(B) A description of any enforcement actions
taken to carry out this section, including any
penalties imposed under subsection (b), during the
preceding year.
``(2) Annual reports to states.--Not later than April 1 of
each year beginning with 2012, the Secretary shall submit to
States a report that includes a summary of the information
submitted under subsection (a) during the preceding year with
respect to covered recipients in the State.
``(3) Relation to state laws.--
``(A) In general.--Effective on January 1, 2010,
subject to subparagraph (B), the provisions of this
section shall preempt any law or regulation of a State
or of a political subdivision of a State that requires
an applicable manufacturer (as defined in subsection
(g)) to disclose or report information in the
categories (as described in subsection (a)) and the
exclusions in (g)(11)(B) regarding a payment or other
transfer of value provided by the applicable
manufacturer to a covered recipient (as so described),
including such laws or regulations that impose
different schedules or frequency of reporting
(including the timing of reporting of payments made
pursuant to product development agreements and clinical
investigations as provided under subsection (e)),
threshold amounts for reporting of such payments or
transfers of value, reporting formats, or definitions
of covered recipients.
``(B) No preemption of additional requirements.--
Subparagraph (A) shall not preempt any law or
regulation of a State or of a political subdivision of
a State that requires the disclosure or reporting of
information not required to be disclosed or reported
under this section to the extent such information is
not specifically excluded from the reporting
requirements under subsection (g)(11)(B).
``(e) Delayed Reporting for Payments Made Pursuant to Product
Research and Development Agreements, Clinical Investigations, and Pre-
development Research.--In the case of a payment or other transfer of
value made to a covered recipient by an applicable manufacturer
pursuant to a product research and development agreement for services
furnished in connection with research of a potential new medical
technology or application, the development of a new drug, device,
biological, or medical supply, or by an applicable manufacturer in
connection with a clinical investigation, the applicable manufacturer
may report the value of such payment or other transfer of value in the
first reporting period under subsection (a) after the earlier of the
following:
``(1) The date of the approval or clearance of the covered
drug, device, biological, or medical supply by the Food and
Drug Administration.
``(2) Four calendar years after the date such payment or
other transfer of value was made.
``(f) Implementation.--The Secretary shall consult with the
Inspector General of the Department of Health and Human Services on the
implementation of this section.
``(g) Definitions.--In this section:
``(1) Applicable distributor.--The term `applicable
distributor' means an entity, other than an applicable group
purchasing organization, that buys and resells, or receives a
commission or other similar form of payment, from another
seller, for selling or arranging for the sale of a covered
drug, device, biological, or medical supply.
``(2) Applicable group purchasing organization.--The term
`applicable group purchasing organization' means a group
purchasing organization (as defined by the Secretary) that
purchases, arranges for, or negotiates the purchase of a
covered drug, device, biological, or medical supply.
``(3) Applicable manufacturer.--The term `applicable
manufacturer' means a manufacturer of a covered drug, device,
biological, or medical supply.
``(4) Clinical investigation.--The term `clinical
investigation' means any experiment involving 1 or more human
subjects, or materials derived from human subjects, in which a
drug or device is administered, dispensed, or used.
``(5) Covered device.--The term `covered 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).
``(6) Covered drug, device, biological, or medical
supply.--The term `covered drug, device, biological, 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).
``(7) Covered recipient.--The term `covered recipient'
means the following:
``(A) A physician.
``(B) A physician medical practice.
``(C) A physician group practice.
``(8) Employee.--The term `employee' has the meaning given
such term in section 1877(h)(2).
``(9) Knowingly.--The term `knowingly' has the meaning
given such term in section 3729(b) of title 31, United States
Code.
``(10) Manufacturer of a covered drug, device, biological,
or medical supply.--The term `manufacturer of a covered drug,
device, biological, or medical supply' means any entity which
is engaged in the production, preparation, propagation,
compounding, conversion, processing, marketing, or distribution
of a covered drug, device, biological, or medical supply (or
any subsidiary of or entity under common ownership with such
entity).
``(11) 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, subject to
subparagraph (B), without limitation, any compensation,
gift, honorarium, speaking fee, consulting fee, travel,
services, dividend, profit distribution, stock or stock
option grant, or ownership or investment interest.
``(B) Exclusions.--An applicable manufacturer shall
not be required to submit information under subsection
(a) with respect to the following:
``(i) Product samples that are not intended
to be sold and are intended for patient use.
``(ii) Educational materials that directly
benefit patients or are intended for patient
use.
``(iii) The loan of a covered device for a
short-term trial period, not to exceed 90 days,
to permit evaluation of the covered device by
the covered recipient.
``(iv) Items or services provided under a
contractual warranty, including the replacement
of a covered device, where the terms of the
warranty are set forth in the purchase or lease
agreement for the covered device.
``(v) A transfer of anything of value to a
covered recipient when the covered recipient is
a patient and not acting in the professional
capacity of a covered recipient.
``(vi) Discounts (including rebates).
``(vii) In-kind items used for the
provision of charity care.
``(viii) A dividend or other profit
distribution from, or ownership or investment
interest in, a publicly traded security and
mutual fund (as described in section 1877(c)).
``(ix) Payments made to a covered recipient
by an applicable manufacturer or by a health
plan affiliated with an applicable manufacturer
for medical care provided to employees of such
manufacturer and their dependents.
``(12) Physician.--The term `physician' has the meaning
given that term in section 1861(r). For purposes of this
section, such term does not include a physician who is an
employee of the applicable manufacturer that is required to
submit information under subsection (a).''.
<all>
Introduced in House
Introduced in House
Referred to House Energy and Commerce
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.
Referred to House Ways and Means
Referred to the Subcommittee on Health.
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