Facing lower reimbursements and growing demands for price transparency, hospitals are demanding more evidence of differentiated value as they select medical device products. Moreover, hospitals are seeking performance guarantees and other risk-sharing arrangements in the hopes that they can offset the financial risks they are assuming by adopting population health…
The individual and SHOP (small business health options program) exchanges are getting significant media attention these days. When PPACA was enacted in 2010, one of its components was the creation of federal and state-based exchanges. The intent of these new marketplaces was to give more Americans access to affordable, quality…
Global healthcare systems are currently undergoing major transformations spurred by increasing regulation, record public debt and shrinking budgets. The U.S. has the dubious distinction of leading the way in this regard. The mandates of the Affordable Care Act, along with shrinking reimbursement to providers are fundamentally changing the operation of…
The approval last year in the EU of generic Remicade represents a milestone of sorts. Biosimilars aim to replace, or at least compete with, products that generated over $100 billion in worldwide sales in 2013. While Europe has led the way in the development of a regulatory pathway for the…
Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear…
Unsustainable growth of health costs along with inconsistent clinical outcomes has forced the U.S. to reevaluate how healthcare is delivered. Healthcare costs have grown from 7.2% of GDP in 1970 to 17.9% in 2009 and 2010. Despite this spending increase, Americans’ average life expectancy and the efficiency of our healthcare…
