In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. 

In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.

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