A Victory for Patients and Personalized Medicine

President Obama signed landmark health care reform legislation into law today which represents a major victory for personalized medicine.  This legislation is the first time that the principles of personalized medicine were formally voted on and passed by both houses of Congress and signed into law by a president.  This bill not only recognizes the emerging science of personalized medicine, but ensures it is aligned with the conduct and use of comparative effectiveness research (CER).

Good news aside, there is a lot of confusion about what was actually signed into law and I’d like to help clarify.

On Sunday, the House passed the same bill that the Senate passed on Christmas Eve, H.R. 3590, that incorporated personalized medicine throughout the structure of its CER provisions.  Therefore, health care reform will:

• Expand the research agenda to include primary research on molecularly-informed trials;
• Ensure research recognizes  potential differences including genetic and molecular sub-typing;
• Improve the quality of the science generated from CER by incorporating new information and technological innovations into its studies, reviewing and updating evidence as necessary, and outlining what future research will be necessary to address perceived gaps;
• Incorporate research on patient preferences in the scope of work, including patient quality of life and physician choice; and
• Create an independent research methods committee that includes experts in molecular diagnostics;

After it passed H.R. 3590, the House then passed a reconciliation package (H.R. 4872).  Note that the version of H.R. 4872 approved by the Rules Committee is not the same as the version of H.R. 4872 that was approved earlier by the Budget Committee.  This earlier version contained placeholder language that was replaced with the reconciliation package.  The reconciliation package included a smaller set of changes (e.g., changing the excise tax on high-cost health plans) that does NOT mention CER.  Therefore, it is likely that the Senate version of CER signed into law today—which recognizes personalized medicine throughout its provisions—will not be changed by the Senate in reconciliation.  The Senate is scheduled to consider that package this week.

As of the President’s signing earlier today, the United States has a health care reform bill that recognizes personalized medicine as the law of the land.  Implementation will require a lot of work to ensure that CER is personalized—work to which the Personalized Medicine Coalition is committed.