This is the second installment in a series of client alerts by Foley's Life Sciences Industry Team highlighting the provisions of the Patient Protection and Affordable Care Act that will likely have significant implications for life sciences companies.
On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (Act). This article provides a brief overview of some provisions within this complex health care reform bill that will likely impact how life sciences companies develop and market products that support personalized medicine.
Personalized medicine seeks to identify the most effective preventive and therapeutic care for each individual patient. While much of the research and development in the field of personalized medicine focuses on the testing and analysis of an individual’s genetics and the tools to perform the tests, the field also encompasses preventive care taking into consideration an individual’s personal and family medical history.
Significant advances have already been made in the use of genetic tests to identify the most effective treatment for individual breast and colon cancer patients. Additional discoveries are anticipated as supporting technologies such as gene sequencing become less costly and as the collection and analysis of data regarding the effectiveness of comparable therapies in different individuals and subpopulations is expanded.
Several key provisions of the Act support future research and development that may, in turn, advance the availability and implementation of personalized medicine beyond its presently limited applications. For example, Section 3011 of the Act prioritizes the establishment of a national strategy to improve the delivery of health care services, patient health care outcomes, and population health. The national strategy must, in part, enhance the use of health care data to improve quality and efficiency and address gaps in quality, efficiency, comparative effectiveness information, and health outcome measures and the collection of data.
Section 3013 authorizes the Secretary of Health and Human Services (Secretary) to give funding priority to the development of quality measures that allow the assessment of the efficiency of care as well as the safety, effectiveness, patient-centeredness, and appropriateness of patient care as part of the national strategy to improve health care quality. "Quality measure" means a standard for measuring the performance and improvement of population health or of health plans, providers of services, and other clinicians in the delivery of health care. In awarding funding (the Act authorizes the appropriation of $75 million for each of fiscal years 2010 through 2014, with amounts appropriated to remain available until expended), the Act requires that the Secretary shall give priority to the development of quality measures that allow the assessment of several factors. As relevant here, those factors include health outcomes and the functional status of patients, and the experience, quality, and use of information provided about and used to inform decision-making about treatment options.
Section 3113 authorizes the Secretary to conduct a demonstration project to allow separate payment under Medicare Part B, at rates to be determined by the Secretary, for covered 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, under certain limited circumstances. While the demonstration 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).
Individualized preventive care is supported as well. For example, Section 4103 supports Medicare coverage for an annual "wellness visit," to include a personalized prevention plan for an individual that takes into account the results of a health risk assessment. In addition, the prevention plan should provide personalized health advice aimed at reducing identified risk factors and improving self-management of an individual’s health care and treatment. While perhaps rudimentary in nature, the focus on individualized medical risks is further evidence that Congress may provide support for Medicare to expand coverage for medical care and planning, which can help to avoid or reduce disease, rather than limiting Medicare coverage to the diagnosis or treatment of existing medical conditions.
Studies in comparative effectiveness also are supported. Section 6301 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 more medical treatments such as therapies, diagnostic tools, and pharmaceuticals (including drugs and biologicals). The research funded under this section must take into account, as appropriate, the potential for differences in the effectiveness of health care treatments in various subpopulations; for example, individuals with different genetic and molecular sub-types. 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 health care coverage to an individual based on the individual’s genetic information.
The groundwork set by the sequencing of the human genome in the late 1990s provided the tools and basic research that launched the era of personalized medicine. Through this basic research, it is now known that many diseases occur through divergent pathways and that predisposition to certain diseases and the likely effectiveness of certain treatments can be identified through an analysis of an individual’s genetics. However, the full promise of this technology has yet to be realized. Several provisions in the Act reflect Congress’s recognition of the importance of personalized medicine to improving health care and making cost-effective treatment decisions; these provisions also provide vital support for further development of this promising technology and its implementation for preventive as well as therapeutic care.
View our recent client alert, "United States Enacts Approval Pathway for Biosimilars," at http://www.foley.com/publications/pub_detail.aspx?pubid=6965.
Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and colleagues. If you have any questions about this alert or would like to discuss the topic further, please contact your Foley attorney or the following:
Antoinette F. Konski
Palo Alto, California
Courtenay C. Brinckerhoff
Judith A. Waltz
San Francisco, California