WASHINGTON, June 27, 2011 /PRNewswire/ -- The Deloitte Center for Health Solutions provides an update on the legislative mandate for a U.S. consumer effectiveness research (CER) initiative in a new report released today called "Comparative Effectiveness Research in the United States: Update and Implications."  The brief also offers an overview of lessons learned from international CER experiences as U.S. policy makers and stakeholders begin CER implementation.

"CER is not widely understood. It is a threat to some and a forceful change for all stakeholders in the U.S. system," said Paul Keckley, Ph.D., executive director of the Deloitte Center for Health Solutions.  "CER is also not a new idea, as many of the world's developed health care systems use a deliberate process to synthesize scientific studies and determine optimal courses of care.  By contrast, the U.S. system is fragmented, processes vary, results are inconsistent and applications of CER advisories range from simple information to strictly controlled coverage guidelines."

The CER mandate of the health care reform law, the Patient Protection and Affordable Care Act (ACA), complements other provisions of the reform strategy, all of which are intended to profoundly impact the quality and value of the current health care system.  The mandate outlines a role for a new, independent CER entity, the Patient-Centered Outcomes Research Institute (PCORI), to oversee and set guidelines for CER.  The organization will sponsor scientifically rigorous studies in order to assist patients, clinicians, payers and policy makers in making informed health care decisions.  

According to the report, CER experiences in industrialized nations such as England, Germany, Canada and Australia provide significant insights for the United States, including:

• Mandated structural opportunities for involving a range of health care sector stakeholders in evaluative and decision-making bodies;
• Operational independence of the evaluative body including an arm's-length relationship from the government;
• Methodological and scientific rigor and transparency of research process and outcomes including open and public accountability;
• Structures and processes by which decisions and recommendations can be appealed and subjected to additional scrutiny and accountability;
• Priority-setting and timeliness of research relates to the health care objectives of the government and society at large;
• Commitment to clinical implementation and patient benefit including ways to facilitate the uptake of new technologies, products, and clinical processes for timeliness of research, optimal outcomes, and greater efficiencies; and
• Investment of sufficient resources for the CER body and its activities.

The Deloitte report also provides an overview of CER implications for key health care stakeholders including life sciences companies, health care providers, payers, consumers and state and federal government agencies.

"In a new value-driven health care system, pharmaceutical and medical device manufacturers will need to offer technologies that demonstrate real value to payers, providers and patients," said Terry Hisey, vice chairman and U.S. life sciences industry leader, Deloitte LLP.  "Product differentiation and value will need to occur throughout the product lifecycle, from discovery to launch.  Safety and efficacy demonstrated under ideal conditions will no longer be sufficient to gain and/or maintain market access; incremental value over other treatment options will become a decision point."

In the United States, the effectiveness of CER and its facilitator, PCORI, is dependent on three key factors:  

• Educating consumers about evidence-based care and its association with improved outcomes for patient populations;
• Creating meaningful information technologies and real-time tools to equip providers, consumer and payers in decisions about care;
• Maintaining the independence of PCORI and overall CER processes from political and regulatory endeavors that might compromise their mission and scope.

"CER, through PCORI, is really about providing tools, not rules to enable the U.S. health care system to align its diagnostics and treatments with evidence and equip consumers to be active participants in their care," concluded Keckley.  "While CER's ability to reduce costs is inconclusive, there is clear evidence of its positive impact on the quality and value of health care services."

For more information, please visit:

Comparative Effectiveness Issue Brief:  www.deloitte.com/us/CERupdate2011

Meet Paul Keckley: www.deloitte.com/us/paulkeckley  

Meet Terry Hisey: www.deloitte.com/us/terryhisey

Deloitte Center for Health Solutions: www.deloitte.com/centerforhealthsolutions

Health Reform Monday Memo: www.deloitte.com/us/healthmemos

As used in this document, "Deloitte" means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.

SOURCE Deloitte