1.This Act may be cited as the
Physician Payments Sunshine Act of
2009
.
2.Transparency
reports and reporting of physician ownership or investment
interestsPart 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:
1128G.Transparency
reports and reporting of physician ownership or investment interests
(a)
(1)Payments or
other transfers of value
(A)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)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 valueIn 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)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)
(A)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)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)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)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)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)
(A)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)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)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)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
congressNot 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)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)
(A)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 requirementsSubparagraph (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 researchIn 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)The
Secretary shall consult with the Inspector General of the Department of Health
and Human Services on the implementation of this section.
(g)In
this section:
(1)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 organizationThe 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)The term applicable manufacturer means
a manufacturer of a covered drug, device, biological, or medical supply.
(4)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)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 supplyThe 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)The term covered recipient means the
following:
(A)A
physician.
(B)A physician
medical practice.
(C)A physician group
practice.
(8)The
term employee has the meaning given such term in section
1877(h)(2).
(9)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 supplyThe 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)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)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)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).
.