What can we learn from the U.S. expanded end-stage renal disease bundle?

Episode-based payment, commonly referred to as bundled payment, has emerged as a key component of U.S. health care payment reform.

FDA actions against health economic promotions, 2002-2011.

Objective: To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading.

Methods: We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.

Therapies for advanced cancers pose a special challenge for health technology assessment organizations in many countries.

Health technology assessment organizations evaluate medical therapies and technologies to help inform coverage and reimbursement decisions for payers around the globe. Even as they establish strict review processes, these organizations--and the reimbursement authorities that use their assessments--have sometimes handled cancer interventions with special care. We found that some countries have created separate health technology assessment pathways for cancer treatment, while others have eased access to cancer treatments through end-of-life or disease-severity exceptions within health technology assessment policies.