12 2 STA T . 2 587PUBLIC LA W 11 0– 275 —J UL Y 15 , 2008 SEC.184 .C O S T- S HARINGF ORC L INICAL TRIALS. Section183 3o f t h e Soci al Sec ur it yA ct (42U. S. C . 13 95 l ), a s a m en d ed b y section 151(a), is amended by addin g at the end the follo w ing new subsection
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‘(w) METHODS O FPAYM E N T. —T he Secretary may de v elo p 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 D epartment of H ealth and Human Services, as determined by the Secretary, to those that would other- wise apply under this section, to the e x tent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where mas k ing the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design. ’ ’. SEC. 18 5 .A D DRESSING HEALTH CARE DIS P ARITIES. Title XVI II of the Social Security Act (42 U.S.C. 1395 et se q .) is amended by inserting after section 18 0 8 the following new section: ‘‘ADD R ESS I N G HEA L TH C ARE DIS P ARITIES ‘‘SEC. 1809. (a) EV AL U ATING DATA COLLECTION APPROACHES.— The Secretary shall evaluate approaches for the collection of data under this title, to be performed in con j unction 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) Minimi z ing 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) R EPORTS TO CONGRESS.— ‘‘(1) REPORT ON EVALUATION.— N ot 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 42USC1395b– 1 0.
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