880 
the Secretary for purposes of carrying out this sec-
tion for each of the fiscal years 2010 through 2014. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
For purposes of carrying out the provisions of this 
section, in addition to funds otherwise available, out 
of any funds in the Treasury not otherwise appro-
priated, there are appropriated to the Secretary of 
Health and Human Services $25,000,000 for each 
of the fiscal years 2010 through 2014. 
‘‘SEC. 1193. GAO EVALUATION OF DATA COLLECTION PROC-
ESS FOR QUALITY MEASUREMENT. 
‘‘(a) GAO EVALUATIONS.—The Comptroller General 
of the United States shall conduct periodic evaluations of 
the implementation of the data collection processes for 
quality measures used by the Secretary. 
‘‘(b) CONSIDERATIONS.—In carrying out the evalua-
tion under subsection (a), the Comptroller General shall 
determine— 
‘‘(1) whether the system for the collection of 
data for quality measures provides for validation of 
data as relevant and scientifically credible; 
‘‘(2) whether data collection efforts under the 
system use the most efficient and cost-effective 
means in a manner that minimizes administrative 
burden on persons required to collect data and that 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00880
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
881 
adequately protects the privacy of patients’ personal 
health information and provides data security; 
‘‘(3) whether standards under the system pro-
vide for an appropriate opportunity for physicians 
and other clinicians and institutional providers of 
services to review and correct findings; and 
‘‘(4) the extent to which quality measures are 
consistent with section 1192(c)(1) or result in direct 
or indirect costs to users of such measures. 
‘‘(c) REPORT.—The Comptroller General shall sub-
mit reports to Congress and to the Secretary containing 
a description of the findings and conclusions of the results 
of each such evaluation.’’. 
SEC. 1443. MULTI-STAKEHOLDER PRE-RULEMAKING INPUT 
INTO SELECTION OF QUALITY MEASURES. 
Section 1808 of the Social Security Act (42 U.S.C. 
1395b–9) is amended by adding at the end the following 
new subsection: 
‘‘(d) MULTI-STAKEHOLDER PRE-RULEMAKING INPUT 
INTO SELECTION OF QUALITY MEASURES.— 
‘‘(1) LIST OF MEASURES.—Not later than De-
cember 1 before each year (beginning with 2011), 
the Secretary shall make public a list of measures 
being considered for selection for quality measure-
ment by the Secretary in rulemaking with respect to 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00881
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
882 
payment systems under this title beginning in the 
payment year beginning in such year and for pay-
ment systems beginning in the calendar year fol-
lowing such year, as the case may be. 
‘‘(2) CONSULTATION
ON
SELECTION
OF
EN-
DORSED
QUALITY
MEASURES.—A consensus-based 
entity that has entered into a contract under section 
1890 shall, as part of such contract, convene multi- 
stakeholder groups to provide recommendations on 
the selection of individual or composite quality meas-
ures, for use in reporting performance information 
to the public or for use in public health care pro-
grams. 
‘‘(3) MULTI-STAKEHOLDER INPUT.—Not later 
than February 1 of each year (beginning with 
2011), the consensus-based entity described in para-
graph (2) shall transmit to the Secretary the rec-
ommendations of multi-stakeholder groups provided 
under paragraph (2). Such recommendations shall 
be included in the transmissions the consensus-based 
entity makes to the Secretary under the contract 
provided for under section 1890. 
‘‘(4) REQUIREMENT
FOR
TRANSPARENCY
IN 
PROCESS.— 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00882
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
883 
‘‘(A) IN
GENERAL.—In convening multi- 
stakeholder groups under paragraph (2) with 
respect to the selection of quality measures, the 
consensus-based entity described in such para-
graph shall provide for an open and transparent 
process for the activities conducted pursuant to 
such convening. 
‘‘(B) SELECTION OF ORGANIZATIONS PAR-
TICIPATING
IN
MULTI-STAKEHOLDER 
GROUPS.—The process under paragraph (2) 
shall ensure that the selection of representatives 
of multi-stakeholder groups includes provision 
for public nominations for, and the opportunity 
for public comment on, such selection. 
‘‘(5) USE OF INPUT.—The respective proposed 
rule shall contain a summary of the recommenda-
tions made by the multi-stakeholder groups under 
paragraph (2), as well as other comments received 
regarding the proposed measures, and the extent to 
which such proposed rule follows such recommenda-
tions and the rationale for not following such rec-
ommendations. 
‘‘(6) MULTI-STAKEHOLDER GROUPS.—For pur-
poses of this subsection, the term ‘multi-stakeholder 
groups’ means, with respect to a quality measure, a 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00883
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
884 
voluntary collaborative of organizations representing 
persons interested in or affected by the use of such 
quality measure, such as the following: 
‘‘(A) Hospitals and other institutional pro-
viders. 
‘‘(B) Physicians. 
‘‘(C) Health care quality alliances. 
‘‘(D) Nurses and other health care practi-
tioners. 
‘‘(E) Health plans. 
‘‘(F) Patient advocates and consumer 
groups. 
‘‘(G) Employers. 
‘‘(H) Public and private purchasers of 
health care items and services. 
‘‘(I) Labor organizations. 
‘‘(J) Relevant departments or agencies of 
the United States. 
‘‘(K) Biopharmaceutical companies and 
manufacturers of medical devices. 
‘‘(L) Licensing, credentialing, and accred-
iting bodies. 
‘‘(7) FUNDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
provide for the transfer, from the Federal Hos-
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00884
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
885 
pital Insurance Trust Fund under section 1817 
and the Federal Supplementary Medical Insur-
ance Trust Fund under section 1841 (in such 
proportion as the Secretary determines appro-
priate), of $1,000,000, to the Secretary for pur-
poses of carrying out this subsection for each of 
the fiscal years 2010 through 2014. 
‘‘(B) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For purposes of carrying out the provi-
sions of this subsection, in addition to funds 
otherwise available, out of any funds in the 
Treasury not otherwise appropriated, there are 
appropriated to the Secretary of Health and 
Human Services $1,000,000 for each of the fis-
cal years 2010 through 2014.’’. 
SEC. 1444. APPLICATION OF QUALITY MEASURES. 
(a) 
INPATIENT
HOSPITAL
SERVICES.—Section 
1886(b)(3)(B) of such Act (42 U.S.C. 1395ww(b)(3)(B)) 
is amended by adding at the end the following new clause: 
‘‘(x)(I) Subject to subclause (II), for purposes of re-
porting data on quality measures for inpatient hospital 
services furnished during fiscal year 2012 and each subse-
quent fiscal year, the quality measures specified under 
clause (viii) shall be measures selected by the Secretary 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00885
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
886 
from measures that have been endorsed by the entity with 
a contract with the Secretary under section 1890(a). 
‘‘(II) In the case of a specified area or medical topic 
determined appropriate by the Secretary for which a fea-
sible and practical quality measure has not been endorsed 
by the entity with a contract under section 1890(a), the 
Secretary may specify a measure that is not so endorsed 
as long as due consideration is given to measures that 
have been endorsed or adopted by a consensus organiza-
tion identified by the Secretary. The Secretary shall sub-
mit such a non-endorsed measure to the entity for consid-
eration for endorsement. If the entity considers but does 
not endorse such a measure and if the Secretary does not 
phase-out use of such measure, the Secretary shall include 
the rationale for continued use of such a measure in rule-
making.’’. 
(b) OUTPATIENT
HOSPITAL
SERVICES.—Section 
1833(t)(17) of such Act (42 U.S.C. 1395l(t)(17)) is 
amended by adding at the end the following new subpara-
graph: 
‘‘(F) USE OF ENDORSED QUALITY MEAS-
URES.—The provisions of clause (x) of section 
1886(b)(3)(C) shall apply to quality measures 
for covered OPD services under this paragraph 
in the same manner as such provisions apply to 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00886
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
887 
quality measures for inpatient hospital serv-
ices.’’. 
(c) 
PHYSICIANS’ 
SERVICES.—Section 
1848(k)(2)(C)(ii) of such Act (42 U.S.C. 1395w- 
4(k)(2)(C)(ii)) is amended by adding at the end the fol-
lowing: ‘‘The Secretary shall submit such a non-endorsed 
measure to the entity for consideration for endorsement. 
If the entity considers but does not endorse such a meas-
ure and if the Secretary does not phase-out use of such 
measure, the Secretary shall include the rationale for con-
tinued use of such a measure in rulemaking.’’. 
(d) 
RENAL
DIALYSIS
SERVICES.—Section 
1881(h)(2)(B)(ii) 
of 
such 
Act 
(42 
U.S.C. 
1395rr(h)(2)(B)(ii)) is amended by adding at the end the 
following: ‘‘The Secretary shall submit such a non-en-
dorsed measure to the entity for consideration for endorse-
ment. If the entity considers but does not endorse such 
a measure and if the Secretary does not phase-out use 
of such measure, the Secretary shall include the rationale 
for continued use of such a measure in rulemaking.’’. 
(e) 
ENDORSEMENT
OF
STANDARDS.—Section 
1890(b)(2) of the Social Security Act (42 U.S.C. 
1395aaa(b)(2)) is amended by adding after and below sub-
paragraph (B) the following: 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00887
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
888 
‘‘If the entity does not endorse a measure, such enti-
ty shall explain the reasons and provide suggestions 
about changes to such measure that might make it 
a potentially endorsable measure.’’. 
(f) EFFECTIVE DATE.—Except as otherwise pro-
vided, the amendments made by this section shall apply 
to quality measures applied for payment years beginning 
with 2012 or fiscal year 2012, as the case may be. 
SEC. 1445. CONSENSUS-BASED ENTITY FUNDING. 
Section 1890(d) of the Social Security Act (42 U.S.C. 
1395aaa(d)) is amended by striking ‘‘for each of fiscal 
years 2009 through 2012’’ and inserting ‘‘for fiscal year 
2009, and $12,000,000 for each of the fiscal years 2010 
through 2012’’ 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00888
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
889 
Subtitle D—Physician Payments 
Sunshine Provision 
SEC. 1451. REPORTS ON FINANCIAL RELATIONSHIPS BE-
TWEEN 
MANUFACTURERS 
AND 
DISTRIBU-
TORS 
OF 
COVERED 
DRUGS, 
DEVICES, 
BIOLOGICALS, 
OR 
MEDICAL 
SUPPLIES 
UNDER MEDICARE, MEDICAID, OR CHIP AND 
PHYSICIANS AND OTHER HEALTH CARE ENTI-
TIES AND BETWEEN PHYSICIANS AND OTHER 
HEALTH CARE ENTITIES. 
(a) IN GENERAL.—Part A of title XI of the Social 
Security Act (42 U.S.C. 1301 et seq.), as amended by sec-
tion 1631(a), is further amended by inserting after section 
1128G the following new section: 
‘‘SEC. 1128H. FINANCIAL REPORTS ON PHYSICIANS’ FINAN-
CIAL RELATIONSHIPS WITH MANUFACTUR-
ERS 
AND 
DISTRIBUTORS 
OF 
COVERED 
DRUGS, DEVICES, BIOLOGICALS, OR MEDICAL 
SUPPLIES UNDER MEDICARE, MEDICAID, OR 
CHIP AND WITH ENTITIES THAT BILL FOR 
SERVICES UNDER MEDICARE. 
‘‘(a) REPORTING OF PAYMENTS OR OTHER TRANS-
FERS OF VALUE.— 
‘‘(1) IN GENERAL.—Except as provided in this 
subsection, not later than March 31, 2011, and an-
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00889
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
890 
nually thereafter, each applicable manufacturer or 
distributor that provides a payment or other transfer 
of value to a covered recipient, or to an entity or in-
dividual 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 pre-
ceding calendar year: 
‘‘(A) With respect to the covered recipient, 
the recipient’s name, business address, physi-
cian specialty, and national provider identifier. 
‘‘(B) With respect to the payment or other 
transfer of value, other than a drug sample— 
‘‘(i) its value and date; 
‘‘(ii) the name of the related drug, de-
vice, or supply, if available, to the level of 
specificity available; and 
‘‘(iii) a description of its form, indi-
cated (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, divi-
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00890
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS
910 
and (e) during the preceding year with respect to covered 
recipients or other hospitals and entities in the State. 
‘‘(h) RELATION TO STATE LAWS.— 
‘‘(1) IN
GENERAL.—Effective on January 1, 
2011, subject to paragraph (2), 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 and applicable 
distributor (as such terms are defined in subsection 
(f)) to disclose or report, in any format, the type of 
information (described in subsection (a)) regarding a 
payment or other transfer of value provided by the 
manufacturer to a covered recipient (as so defined). 
‘‘(2) NO
PREEMPTION
OF
ADDITIONAL
RE-
QUIREMENTS.—Paragraph (1) shall not preempt any 
statute or regulation of a State or political subdivi-
sion of a State that requires any of the following: 
‘‘(A) The disclosure or reporting of infor-
mation not of the type required to be disclosed 
or reported under this section. 
‘‘(B) The disclosure or reporting, in any 
format, of information described in subsection 
(f)(8)(C), except in the case of information de-
scribed in clause (i) of subsection (f)(8)(C). 
VerDate Nov 24 2008 
12:56 Oct 30, 2009
Jkt 089200
PO 00000
Frm 00910
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS