On March 21, 2010 the US House of Representatives voted to pass the healthcare reform bill, H.R. 3590, which ensures that the field of personalized molecular medicine is moving closer to becoming a part of the national healthcare agenda.
In its current form, H.R. 3590 includes a section creating an independent Patient-Centered Outcomes Research Institute. The non-profit institute will be charged with conducting research that informs the public and healthcare providers about the comparative risks and benefits of marketed drugs, medical devices, and medical products. Effectiveness will be determined as differentiated by race, ethnicity, sex, age, co-morbidities, and genetic and molecular subtypes. This latter stratification is the basis for personalized molecular medicine.
"For personalized medicine, this vote is historic," Amy Miller, public policy director at the Personalized Medicine Coalition, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week. "It represents the first time that the principles of personalized medicine have been passed by both houses of Congress."
President Barack Obama is expected to sign the healthcare reform bill into law on March 23. Following that, the Senate is scheduled to vote on a companion bill of proposed changes made by House Democrats to the main healthcare reform legislation. This so-called "reconciliation side car" bill passed in the House 220-211. The Senate is slated to vote on this bill by Saturday, March 27.
Despite these remaining processes and potential hurdles — as a dozen states plan to challenge the constitutionality of the healthcare reform bill in the courts — chances are high that the bill, including the personalized medicine-friendly provisions within the comparative effectiveness research initiatives, will become law.
Originally, the section on CER in the House version of the bill did not contain language specifically on genomic subpopulations. However, it seems the House listened to the suggestions of personalized medicine proponents, such as NIH Director Francis Collins and members of the Personalized Medicine Coalition, to ensure that CER initiatives in the healthcare reform bill included research into genomically defined subpopulations.
In addition to the creation of the Patient-Centered Outcomes Research Institute, H.R. 3590 instructs for the establishment of a 15-member methodology committee that will be responsible for "developing and improving the science and methods of comparative clinical effectiveness research." Members of this committee will be experts from various fields, including genomics and biostatistics.