On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (the Act). This Legal News Alert provides a brief outline of different provisions within this complex piece of legislation that may affect life sciences companies, including a new tax program, new grant programs, and a new research institute that may be of particular interest to life sciences companies.
New Tax Credit
Title IX, Subtitle B (Section 9023), creates a new tax credit, the Qualifying Therapeutic Discovery Project Credit, for entities with 250 or fewer employees. Such entities can apply to receive a tax credit under the following guidelines for certain research expenditures, including:
New Grant Programs
Cures Acceleration Network (CAN)
Title IV, Subtitle C (as amended by Title X, Subtitle D) (Section 10409), directs NIH to create a Cures Acceleration Network having a mission that includes:
CAN will be governed by a board composed of 24 members, including one each from areas relating to basic research, medicine, biopharmaceuticals, discovery and delivery of medical products, bioinformatics and gene therapy, medical instrumentation, regulatory review, and approval. The board also will include four experts in venture capital/private equity as well as eight representatives from disease advocacy organizations.
Under this new grant program:
Other Grant Programs
A sampling of other grant programs in the Act include:
Title III, Subtitle F (Section 3504), establishes support for NIH grants to study the basic science of emergency medicine and to study the efficacy, safety, and health outcomes for medications used for infants, children, and adolescents in emergency care settings.
Title III, Subtitle F (Section 3509), establishes an Office on Women’s Health within HHS and the CDC, both with the general authority to issue grants to support research into women’s health conditions. This section also establishes an Office on Women’s Health in the FDA, which has the following duties:
Title IV, Subtitle B (Section 4102), establishes grants for research-based dental caries disease management, with a focus on children’s health.
Title IV, Subtitle D (Section 4304), establishes grants to improve surveillance for and response to infectious diseases, including strengthening epidemiologic capacity, enhancing laboratory practice, improving information systems, and developing and implementing control strategies. While the grants are targeted for state and local health departments, they also may be available to academic centers that assist state and local health departments.
Title IV, Subtitle D (Section 4305), “encourage[s]” NIH to pursue an aggressive program of research on the causes and treatments of pain.
Title X, Subtitle D (Section 10411), provides that NIH may “expand, intensify and coordinate research” into the causation of congenital heart disease, including genetic causes, diagnosis, treatment, and prevention.
Title X, Subtitle D (Section 10413), directs NIH to conduct research to develop and validate new screening tests and methods for the prevention and early detection of breast cancer in young women (ages 14 – 44).
Of course, not all of the news is good news. Title IX, Subtitle A (Sections 9008, 9009), also includes the negotiated tax contributions from branded prescription pharmaceutical and medical device manufactures.
Patient-Centered Outcomes Research Institute
Title VI, Subtitle D (Sections 6301, 6302), authorizes a new nonprofit, non-government corporation (Patient-Centered Outcomes Research Institute) to be funded by a new Patient-Centered Outcomes Research Trust Fund.
The mission of the new Institute will include:
The enumerated duties of the Institute will include:
Foley recently discussed other provisions of the Act related to Personalized Medicine in a March 6, 2010 Legal News Alert, available online at http://www.foley.com/publications/pub_detail.aspx?pubid=7003.
Medicare Payments for Companion Diagnostics
Title III, Subtitle B, Part I (Section 3113), provides for Medicare payments for certain companion diagnostic tests.
Biologics Price Competition and Innovation Act of 2009
Title VII, Subtitle A (Sections 7001, 7002), provides long-awaited Follow-On Biologics provisions, which include:
Foley recently discussed this act in more detail in a February 29, 2010 Legal News Alert available online at http://www.foley.com/publications/pub_detail.aspx?pubid=6965.
Title III, Subtitle B, Part III (Section 3139), provides for Medicare payments for biosimilar products.
View other news alerts related to the Patient Protection and Affordable Care Act:
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:
Courtenay C. Brinckerhoff
Jackie Wright Bonilla