Comparative Effectiveness Amendment Failed

Another amendment that would prevent the federal government from using certain data for comparative effectiveness data research.

The amendment and vote:


KYL-ROBERTS-CRAPO-CORNYN AMENDMENT #D8 America’s Healthy Future Act of 2009


Short Title: The PATIENTS Act Description: The amendment would add
the “Preserving Access to Targeted, Individualized, and Effective New
Treatments and Services (PATIENTS) Act of 2009” (S.1259).

SECTION 1. SHORT TITLE.

This Act may be cited as the `Preserving Access to Targeted,
Individualized, and Effective New Treatments and Services (PATIENTS)
Act of 2009' or the `PATIENTS Act of 2009'.

SEC. 2. PROHIBITION ON CERTAIN USES OF DATA OBTAINED FROM COMPARATIVE
EFFECTIVENESS RESEARCH; ACCOUNTING FOR PERSONALIZED MEDICINE AND
DIFFERENCES IN PATIENT TREATMENT RESPONSE.

(a) In General- Notwithstanding any other provision of law, the
Secretary of Health and Human Services--

(1) shall not use data obtained from the conduct of comparative
effectiveness research, including such research that is conducted or
supported using funds appropriated under the American Recovery and
Reinvestment Act of 2009 (Public Law 111-5), to deny coverage of an
item or service under a Federal health care program (as defined in
section 1128B(f) of the Social Security Act (42 U.S.C. 1320a-7b(f)));
and

(2) shall ensure that comparative effectiveness research conducted or
supported by the Federal Government accounts for factors contributing
to differences in the treatment response and treatment preferences of
patients, including patient-reported outcomes, genomics and
personalized medicine, the unique needs of health disparity
populations, and indirect patient benefits.

(b) Rule of Construction- Nothing in this section shall be construed
as affecting the authority of the Commissioner of Food and Drugs under
the Federal Food, Drug, and Cosmetic Act or the Public Health Service
Act.


Offset: None

Republicans
CHUCK GRASSLEY -yes
ORRIN G. HATCH -yes
OLYMPIA J. SNOWE- yes
JON KYL -yes
JIM BUNNING -yes
MIKE CRAPO -yes
PAT ROBERTS -yes
JOHN ENSIGN -yes
MIKE ENZI -yes
JOHN CORNYN -yes

Democrats
MAX BAUCUS -no
JOHN D. ROCKEFELLER -no
KENT CONRAD -no
JEFF BINGAMAN -no
JOHN F. KERRY -no
BLANCHE L. LINCOLN -no
RON WYDEN -no
CHARLES E. SCHUMER -no
DEBBIE STABENOW -no
MARIA CANTWELL -no
BILL NELSON -no
ROBERT MENENDEZ -no
THOMAS CARPER -no

Not Agreed to (10-13)