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1 ‘‘(8) MANUFACTURER OF A COVERED DRUG,
2 DEVICE, BIOLOGICAL, OR MEDICAL SUPPLY.—The
3 term ‘manufacturer of a covered drug, device, bio-
4 logical, or medical supply’ means any entity which is
5 engaged in the production, preparation, propagation,
6 compounding, conversion, processing, marketing, or
7 distribution of a covered drug, device, biological, or
8 medical supply (or any subsidiary of or entity affili-
9 ated with such entity).
10 ‘‘(9) PAYMENT OR OTHER TRANSFER OF
11 VALUE.—
12 ‘‘(A) IN GENERAL.—The term ‘payment or
13 other transfer of value’ means a transfer of
14 anything of value for or of any of the following:
15 ‘‘(i) Gift, food, or entertainment.
16 ‘‘(ii) Travel or trip.
17 ‘‘(iii) Honoraria.
18 ‘‘(iv) Research funding or grant.
19 ‘‘(v) Education or conference funding.
20 ‘‘(vi) Consulting fees.
21 ‘‘(vii) Ownership or investment inter-
22 est and royalties or license fee.
23 ‘‘(B) INCLUSIONS.—Subject to subpara-
24 graph (C), the term ‘payment or other transfer
25 of value’ includes any compensation, gift, hono-
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1 rarium, speaking fee, consulting fee, travel,
2 services, dividend, profit distribution, stock or
3 stock option grant, or any ownership or invest-
4 ment interest held by a physician in a manufac-
5 turer (excluding a dividend or other profit dis-
6 tribution from, or ownership or investment in-
7 terest in, a publicly traded security or mutual
8 fund (as described in section 1877(c))).
9 ‘‘(C) EXCLUSIONS.—The term ‘payment or
10 other transfer of value’ does not include the fol-
11 lowing:
12 ‘‘(i) Any payment or other transfer of
13 value provided by an applicable manufac-
14 turer or distributor to a covered recipient
15 where the amount transferred to, requested
16 by, or designated on behalf of the covered
17 recipient does not exceed $5.
18 ‘‘(ii) The loan of a covered device for
19 a short-term trial period, not to exceed 90
20 days, to permit evaluation of the covered
21 device by the covered recipient.
22 ‘‘(iii) Items or services provided under
23 a contractual warranty, including the re-
24 placement of a covered device, where the
25 terms of the warranty are set forth in the
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1 purchase or lease agreement for the cov-
2 ered device.
3 ‘‘(iv) A transfer of anything of value
4 to a covered recipient when the covered re-
5 cipient is a patient and not acting in the
6 professional capacity of a covered recipient.
7 ‘‘(v) In-kind items used for the provi-
8 sion of charity care.
9 ‘‘(vi) A dividend or other profit dis-
10 tribution from, or ownership or investment
11 interest in, a publicly traded security and
12 mutual fund (as described in section
13 1877(c)).
14 ‘‘(vii) Compensation paid by a manu-
15 facturer or distributor of a covered drug,
16 device, biological, or medical supply to a
17 covered recipient who is directly employed
18 by and works solely for such manufacturer
19 or distributor.
20 ‘‘(viii) Any discount or cash rebate.
21 ‘‘(10) PHYSICIAN.—The term ‘physician’ has
22 the meaning given that term in section 1861(r). For
23 purposes of this section, such term does not include
24 a physician who is an employee of the applicable
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1 manufacturer that is required to submit information
2 under subsection (a).
3 ‘‘(g) ANNUAL REPORTS TO STATES.—Not later than
4 April 1 of each year beginning with 2011, the Secretary
5 shall submit to States a report that includes a summary
6 of the information submitted under subsections (a) and
7 (d) during the preceding year with respect to covered re-
8 cipients or other hospitals and entities in the State.
9 ‘‘(h) RELATION TO STATE LAWS.—
10 ‘‘(1) IN GENERAL.—Effective on January 1,
11 2011, subject to paragraph (2), the provisions of
12 this section shall preempt any law or regulation of
13 a State or of a political subdivision of a State that
14 requires an applicable manufacturer and applicable
15 distributor (as such terms are defined in subsection
16 (f)) to disclose or report, in any format, the type of
17 information (described in subsection (a)) regarding a
18 payment or other transfer of value provided by the
19 manufacturer to a covered recipient (as so defined).
20 ‘‘(2) NO PREEMPTION OF ADDITIONAL RE-
21 QUIREMENTS.—Paragraph (1) shall not preempt any
22 law or regulation of a State or of a political subdivi-
23 sion of a State that requires any of the following:
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1 ‘‘(A) The disclosure or reporting of infor-
2 mation not of the type required to be disclosed
3 or reported under this section.
4 ‘‘(B) The disclosure or reporting, in any
5 format, of the type of information required to
6 be disclosed or reported under this section to a
7 Federal, State, or local governmental agency for
8 public health surveillance, investigation, or
9 other public health purposes or health oversight
10 purposes.
11 ‘‘(C) The discovery or admissibility of in-
12 formation described in this section in a crimi-
13 nal, civil, or administrative proceeding.’’.
14 (b) AVAILABILITY OF INFORMATION FROM THE DIS-
15 CLOSURE OF FINANCIAL RELATIONSHIP REPORT
16 (DFRR).—The Secretary of Health and Human Services
17 shall submit to Congress a report on the full results of
18 the Disclosure of Physician Financial Relationships sur-
19 veys required pursuant to section 5006 of the Deficit Re-
20 duction Act of 2005. Such report shall be submitted to
21 Congress not later than the date that is 6 months after
22 the date such surveys are collected and shall be made pub-
23 licly available on an Internet website of the Department
24 of Health and Human Services.
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1 Subtitle E—Public Reporting on
2 Health Care-Associated Infections
3 SEC. 1461. REQUIREMENT FOR PUBLIC REPORTING BY
4 HOSPITALS AND AMBULATORY SURGICAL
5 CENTERS ON HEALTH CARE-ASSOCIATED IN-
6 FECTIONS.
7 (a) IN GENERAL.—Title XI of the Social Security Act
8 is amended by inserting after section 1138 the following
9 section:
10 ‘‘SEC. 1138A. REQUIREMENT FOR PUBLIC REPORTING BY
11 HOSPITALS AND AMBULATORY SURGICAL
12 CENTERS ON HEALTH CARE-ASSOCIATED IN-
13 FECTIONS.
14 ‘‘(a) REPORTING REQUIREMENT.—
15 ‘‘(1) IN GENERAL.—The Secretary shall provide
16 that a hospital (as defined in subsection (g)) or am-
17 bulatory surgical center meeting the requirements of
18 titles XVIII or XIX may participate in the programs
19 established under such titles (pursuant to the appli-
20 cable provisions of law, including sections
21 1866(a)(1) and 1832(a)(1)(F)(i)) only if, in accord-
22 ance with this section, the hospital or center reports
23 such information on health care-associated infections
24 that develop in the hospital or center (and such de-
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1 mographic information associated with such infec-
2 tions) as the Secretary specifies.
3 ‘‘(2) REPORTING PROTOCOLS.— Such informa-
4 tion shall be reported in accordance with reporting
5 protocols established by the Secretary through the
6 Director of the Centers for Disease Control and Pre-
7 vention (in this section referred to as the ‘CDC’)
8 and to the National Healthcare Safety Network of
9 the CDC or under such another reporting system of
10 such Centers as determined appropriate by the Sec-
11 retary in consultation with such Director.
12 ‘‘(3) COORDINATION WITH HIT.—The Sec-
13 retary, through the Director of the CDC and the Of-
14 fice of the National Coordinator for Health Informa-
15 tion Technology, shall ensure that the transmission
16 of information under this subsection is coordinated
17 with systems established under the HITECH Act,
18 where appropriate.
19 ‘‘(4) PROCEDURES TO ENSURE THE VALIDITY
20 OF INFORMATION.—The Secretary shall establish
21 procedures regarding the validity of the information
22 submitted under this subsection in order to ensure
23 that such information is appropriately compared
24 across hospitals and centers. Such procedures shall
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1 address failures to report as well as errors in report-
2 ing.
3 ‘‘(5) IMPLEMENTATION.—Not later than 1 year
4 after the date of enactment of this section, the Sec-
5 retary, through the Director of CDC, shall promul-
6 gate regulations to carry out this section.
7 ‘‘(b) PUBLIC POSTING OF INFORMATION.—The Sec-
8 retary shall promptly post, on the official public Internet
9 site of the Department of Health and Human Services,
10 the information reported under subsection (a). Such infor-
11 mation shall be set forth in a manner that allows for the
12 comparison of information on health care-associated infec-
13 tions—
14 ‘‘(1) among hospitals and ambulatory surgical
15 centers; and
16 ‘‘(2) by demographic information.
17 ‘‘(c) ANNUAL REPORT TO CONGRESS.—On an annual
18 basis the Secretary shall submit to the Congress a report
19 that summarizes each of the following:
20 ‘‘(1) The number and types of health care-asso-
21 ciated infections reported under subsection (a) in
22 hospitals and ambulatory surgical centers during
23 such year.
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