Patents form the basis of the pharma and biotech industry, also called the life sciences industry. They give companies an incentive to make large investments in risky drug development and innovations, which have the potential to be ineffective or to fail Food and Drug Administration (FDA) approval. More than 6,000 U.S. businesses spent...
The 2012 Supreme Court got a lot of attention for its decision to uphold most of the Affordable Care Act (ACA) health reform law in NFIB v. Sebelius. But this year’s court docket will be no dud. There will be a number of interesting and important cases for pharma...
Here is a summary of the Medicare, Medicaid, and other health care related provisions of H.R. 8, the American Taxpayer Relief Act of 2012, as passed by House and Senate as part of the fiscal cliff negotiations. President Obama is expected to sign the law shortly.
The Congressional Budget Office (CBO)...
Fraud and abuse are common and persistent problems for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). Combined federal and state spending now exceeds $1 trillion, with fraud and abuse likely costing taxpayers well over $100 billion annually.
Together with state Medicaid agencies and state attorneys general, several federal offices, such...
The Food and Drug Administration (FDA) reviews the safety and effectiveness of new medical devices sold in the United States, and The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes FDA to collect user fees to support the device submission review process. MDUFMA also establishes performance...
Policymakers expressed concern about the lack in price transparency for implantable medical devices (IMD), with confidentiality clauses in purchasing agreements frequently restricting the release of third-party prices. Because this lack of transparency could drive up hospital cost and Medicare spending, GAO examined trends in IMD Medicare spending and utilization,...
