Personalized medicine seeks to identify the most effective preventive and therapeutic care for each individual patient. Several key provisions of the Act support future R&D that may, in turn, advance the availability and implementation of personalized medicine.
Section 3011 of the Act prioritizes the establishment of a national strategy to improve the delivery of healthcare services, patient healthcare outcomes, and population health. The national strategy must, in part, enhance the use of healthcare data to improve quality and efficiency and address gaps in quality, efficiency, comparative effectiveness information, and health outcome measures as well as the collection of data.
Section 3013 of the Act authorizes the HHS Secretary to give funding priority to the development of quality measures that allow the assessment of several factors related to the efficiency and quality of care. Factors include health outcomes and the functional status of patients as well as the experience, quality, and use of information provided about treatment options to make decisions. The Act allows for the appropriation of $75 million for each of fiscal years 2010 through 2014, with amounts appropriated to remain available until expended.
Under Section 3113, the Secretary can conduct a pilot project to allow separate payment under Medicare Part B at rates to be determined by the Secretary for complex diagnostic tests (as defined by the Act) that link a patient’s genetic makeup to a cancer chemotherapy where no alternative test is available having equivalent performance characteristics and under certain limited circumstances. While the pilot project will be limited to tests on patient samples collected during hospitalization but performed after hospitalization, it will ultimately result in a report to Congress with an assessment of the project’s impact on access to care, quality of care, health outcomes, and Medicare expenditures (including savings).
Studies in comparative effectiveness are supported in Section 6301 of the Act. It establishes a nonprofit corporation, to be known as the Patient-Centered Outcomes Research Institute, to assist in the analysis of the health outcomes and the clinical effectiveness, risks, and benefits of diagnostic tools as well as pharmaceutical drugs and biologics. The research funded under this section must take into account the potential for differences in the effectiveness of healthcare treatments in various subpopulations. Results of the studies are to be published in a format that is comprehensible to patients and providers, with safeguards to protect patient privacy and confidentiality of study subjects.
Finally, Section 1201 of the Act prohibits denial of healthcare coverage to an individual based on the individual’s genetic information.