H. R. 6331—91 
(1) IN GENERAL.—Part E of title XVIII of the Social Security 
Act (42 U.S.C. 1395x et seq.) is amended by inserting after 
section 1889 the following new section: 
‘‘CONTRACT WITH A CONSENSUS-BASED ENTITY REGARDING 
PERFORMANCE MEASUREMENT 
‘‘SEC. 1890. (a) CONTRACT.— 
‘‘(1) IN
GENERAL.—For purposes of activities conducted 
under this Act, the Secretary shall identify and have in effect 
a contract with a consensus-based entity, such as the National 
Quality Forum, that meets the requirements described in sub-
section (c). Such contract shall provide that the entity will 
perform the duties described in subsection (b). 
‘‘(2) TIMING FOR FIRST CONTRACT.—As soon as practicable 
after the date of the enactment of this subsection, the Secretary 
shall enter into the first contract under paragraph (1). 
‘‘(3) PERIOD OF CONTRACT.—A contract under paragraph 
(1) shall be for a period of 4 years (except as may be renewed 
after a subsequent bidding process). 
‘‘(4) COMPETITIVE
PROCEDURES.—Competitive procedures 
(as defined in section 4(5) of the Office of Federal Procurement 
Policy Act (41 U.S.C. 403(5))) shall be used to enter into a 
contract under paragraph (1). 
‘‘(b) DUTIES.—The duties described in this subsection are the 
following: 
‘‘(1) PRIORITY
SETTING
PROCESS.—The entity shall syn-
thesize evidence and convene key stakeholders to make rec-
ommendations, with respect to activities conducted under this 
Act, on an integrated national strategy and priorities for health 
care performance measurement in all applicable settings. In 
making such recommendations, the entity shall— 
‘‘(A) ensure that priority is given to measures— 
‘‘(i) that address the health care provided to 
patients with prevalent, high-cost chronic diseases; 
‘‘(ii) with the greatest potential for improving the 
quality, efficiency, and patient-centeredness of health 
care; and 
‘‘(iii) that may be implemented rapidly due to 
existing evidence, standards of care, or other reasons; 
and 
‘‘(B) take into account measures that— 
‘‘(i) may assist consumers and patients in making 
informed health care decisions; 
‘‘(ii) address health disparities across groups and 
areas; and 
‘‘(iii) address the continuum of care a patient 
receives, including services furnished by multiple 
health care providers or practitioners and across mul-
tiple settings. 
‘‘(2) ENDORSEMENT OF MEASURES.—The entity shall provide 
for the endorsement of standardized health care performance 
measures. The endorsement process under the preceding sen-
tence shall consider whether a measure— 
‘‘(A) is evidence-based, reliable, valid, verifiable, rel-
evant to enhanced health outcomes, actionable at the care-
giver level, feasible to collect and report, and responsive 
to variations in patient characteristics, such as health
H. R. 6331—92 
status, language capabilities, race or ethnicity, and income 
level; and 
‘‘(B) is consistent across types of health care providers, 
including hospitals and physicians. 
‘‘(3) MAINTENANCE OF MEASURES.—The entity shall estab-
lish and implement a process to ensure that measures endorsed 
under paragraph (2) are updated (or retired if obsolete) as 
new evidence is developed. 
‘‘(4) PROMOTION
OF
THE
DEVELOPMENT
OF
ELECTRONIC 
HEALTH RECORDS.—The entity shall promote the development 
and use of electronic health records that contain the 
functionality for automated collection, aggregation, and trans-
mission of performance measurement information. 
‘‘(5) ANNUAL REPORT TO CONGRESS AND THE SECRETARY; 
SECRETARIAL PUBLICATION AND COMMENT.— 
‘‘(A) ANNUAL REPORT.—By not later than March 1 of 
each year (beginning with 2009), the entity shall submit 
to Congress and the Secretary a report containing a descrip-
tion of— 
‘‘(i) the implementation of quality measurement 
initiatives under this Act and the coordination of such 
initiatives with quality initiatives implemented by 
other payers; 
‘‘(ii) the recommendations made under paragraph 
(1); and 
‘‘(iii) the performance by the entity of the duties 
required under the contract entered into with the Sec-
retary under subsection (a). 
‘‘(B) SECRETARIAL REVIEW AND PUBLICATION OF ANNUAL 
REPORT.—Not later than 6 months after receiving a report 
under subparagraph (A) for a year, the Secretary shall— 
‘‘(i) review such report; and 
‘‘(ii) publish such report in the Federal Register, 
together with any comments of the Secretary on such 
report. 
‘‘(c) REQUIREMENTS DESCRIBED.—The requirements described 
in this subsection are the following: 
‘‘(1) PRIVATE NONPROFIT.—The entity is a private nonprofit 
entity governed by a board. 
‘‘(2) BOARD MEMBERSHIP.—The members of the board of 
the entity include— 
‘‘(A) representatives of health plans and health care 
providers and practitioners or representatives of groups 
representing such health plans and health care providers 
and practitioners; 
‘‘(B) health care consumers or representatives of groups 
representing health care consumers; and 
‘‘(C) representatives of purchasers and employers or 
representatives of groups representing purchasers or 
employers. 
‘‘(3) ENTITY MEMBERSHIP.—The membership of the entity 
includes persons who have experience with— 
‘‘(A) urban health care issues; 
‘‘(B) safety net health care issues; 
‘‘(C) rural and frontier health care issues; and 
‘‘(D) health care quality and safety issues.
H. R. 6331—93 
‘‘(4) OPEN
AND
TRANSPARENT.—With respect to matters 
related to the contract with the Secretary under subsection 
(a), the entity conducts its business in an open and transparent 
manner and provides the opportunity for public comment on 
its activities. 
‘‘(5) VOLUNTARY CONSENSUS STANDARDS SETTING ORGANIZA-
TION.—The entity operates as a voluntary consensus standards 
setting organization as defined for purposes of section 12(d) 
of the National Technology Transfer and Advancement Act 
of 1995 (Public Law 104–113) and Office of Management and 
Budget Revised Circular A–119 (published in the Federal Reg-
ister on February 10, 1998). 
‘‘(6) EXPERIENCE.—The entity has at least 4 years of experi-
ence in establishing national consensus standards. 
‘‘(7) MEMBERSHIP FEES.—If the entity requires a member-
ship fee for participation in the functions of the entity, such 
fees shall be reasonable and adjusted based on the capacity 
of the potential member to pay the fee. In no case shall member-
ship fees pose a barrier to the participation of individuals 
or groups with low or nominal resources to participate in the 
functions of the entity. 
‘‘(d) FUNDING.—For purposes of carrying out this section, the 
Secretary shall provide for the transfer, from the Federal Hospital 
Insurance Trust Fund under section 1817 and the Federal Supple-
mentary Medical Insurance Trust Fund under section 1841 (in 
such proportion as the Secretary determines appropriate), of 
$10,000,000 to the Centers for Medicare & Medicaid Services Pro-
gram Management Account for each of fiscal years 2009 through 
2012.’’. 
(2) SENSE OF THE SENATE.—It is the Sense of the Senate 
that the selection by the Secretary of Health and Human Serv-
ices of an entity to contract with under section 1890(a) of 
the Social Security Act, as added by paragraph (1), should 
not be construed as diminishing the significant contributions 
of the Boards of Medicine, the quality alliances, and other 
clinical and technical experts to efforts to measure and improve 
the quality of health care services. 
(b) GAO STUDY AND REPORTS ON THE PERFORMANCE AND COSTS 
OF THE CONSENSUS-BASED ENTITY UNDER THE CONTRACT.— 
(1) IN GENERAL.—The Comptroller General of the United 
States shall conduct a study on— 
(A) the performance of the entity with a contract with 
the Secretary of Health and Human Services under section 
1890(a) of the Social Security Act, as added by subsection 
(a), of its duties under such contract; and 
(B) the costs incurred by such entity in performing 
such duties. 
(2) REPORTS.—Not later than 18 months and 36 months 
after the effective date of the first contract entered into under 
such section 1890(a), the Comptroller General of the United 
States shall submit to Congress a report containing the results 
of the study conducted under paragraph (1), together with 
recommendations for such legislation and administrative action 
as the Comptroller General determines appropriate.
H. R. 6331—94 
SEC. 184. COST-SHARING FOR CLINICAL TRIALS. 
Section 1833 of the Social Security Act (42 U.S.C. 1395l), as 
amended by section 151(a), is amended by adding at the end the 
following new subsection: 
‘‘(w) METHODS OF PAYMENT.—The Secretary may develop alter-
native methods of payment for items and services provided under 
clinical trials and comparative effectiveness studies sponsored or 
supported by an agency of the Department of Health and Human 
Services, as determined by the Secretary, to those that would other-
wise apply under this section, to the extent such alternative 
methods are necessary to preserve the scientific validity of such 
trials or studies, such as in the case where masking the identity 
of interventions from patients and investigators is necessary to 
comply with the particular trial or study design.’’. 
SEC. 185. ADDRESSING HEALTH CARE DISPARITIES. 
Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) 
is amended by inserting after section 1808 the following new section: 
‘‘ADDRESSING HEALTH CARE DISPARITIES 
‘‘SEC. 1809. (a) EVALUATING DATA COLLECTION APPROACHES.— 
The Secretary shall evaluate approaches for the collection of data 
under this title, to be performed in conjunction with existing quality 
reporting requirements and programs under this title, that allow 
for the ongoing, accurate, and timely collection and evaluation 
of data on disparities in health care services and performance 
on the basis of race, ethnicity, and gender. In conducting such 
evaluation, the Secretary shall consider the following objectives: 
‘‘(1) Protecting patient privacy. 
‘‘(2) Minimizing the administrative burdens of data collec-
tion and reporting on providers and health plans participating 
under this title. 
‘‘(3) Improving Medicare program data on race, ethnicity, 
and gender. 
‘‘(b) REPORTS TO CONGRESS.— 
‘‘(1) REPORT ON EVALUATION.—Not later than 18 months 
after the date of the enactment of this section, the Secretary 
shall submit to Congress a report on the evaluation conducted 
under subsection (a). Such report shall, taking into consider-
ation the results of such evaluation— 
‘‘(A) identify approaches (including defining methodolo-
gies) for identifying and collecting and evaluating data 
on health care disparities on the basis of race, ethnicity, 
and gender for the original Medicare fee-for-service pro-
gram under parts A and B, the Medicare Advantage pro-
gram under part C, and the Medicare prescription drug 
program under part D; and 
‘‘(B) include recommendations on the most effective 
strategies and approaches to reporting HEDIS quality 
measures as required under section 1852(e)(3) and other 
nationally recognized quality performance measures, as 
appropriate, on the basis of race, ethnicity, and gender. 
‘‘(2) REPORTS ON DATA ANALYSES.—Not later than 4 years 
after the date of the enactment of this section, and 4 years 
thereafter, the Secretary shall submit to Congress a report 
that includes recommendations for improving the identification