Comparative Effectiveness Bill Introduced

Senate Finance Committee Chair Max Baucus (D-Mont) and Senate Budget Committee Chair Kent Conrad (D-ND) have introduced new legislation designed to improve clinical decision-making, enhance quality of medical care, and reduce wasteful spending by comparing the effectiveness of different treatments for the same illness. Called The Patient-Centered Outcomes Research Act of 2009, the bill is similar to comparative effectiveness legislation introduced by Senators Baucus and Conrad last year.

It includes a stipulation that, when two or more treatments for a rare disease are being compared, an expert rare disease advisory panel must be consulted. This is important because some approaches to comparative effectiveness don’t include special provisions for rare diseases.

We are urging our members to contact their senators to ensure that the language related to rare diseases remains in the bill. The specific language is as follows:

"(IV) in the case where the agency, instrumentality, or other entity is managing or conducting a comparative effectiveness research study for a rare disease, consult with the expert advisory panel for rare disease appointed under paragraph (5)(A)(iii) with respect to such research study.” (page 10)

"(iii) EXPERT ADVISORY PANEL FOR RARE DISEASE.—In the case of a comparative effectiveness research study for rare disease, the Institute shall appoint an expert advisory panel for purposes of assisting in the design of such research study and determining the relative value and feasibility of conducting such research study.

"(B) COMPOSITION.—

"(i) IN GENERAL.—An expert advisory panel appointed under subparagraph (A) shall include individuals who have experience in the relevant topic, project, or category for which the panel is established, including—

"(I) practicing and research clinicians (including relevant specialists and subspecialists), patients, and representatives of patients; and “(II) experts in scientific and health services research, health services delivery, and evidence-based medicine.

"(ii) INCLUSION OF REPRESENTATIVES OF MANUFACTURERS OF MEDICAL TECHNOLOGY.—An expert advisory panel appointed under subparagraph (A) may include a representative of each manufacturer of each medical technology that is included under the relevant topic, project, or category for which the panel is established. (page 14)