HEALTHCARE REFORM Comparative Effectiveness Research (CER) SEPTEMBER 2011 The enclosed slides are intended to provide you with an overview of comparative effectiveness research (CER) policies included in healthcare reform. This tool is de- signed to help distributors and manufacturers understand how the research outcomes and recommendations of CER will impact the decisions of healthcare providers. For example, certain research findings could lead healthcare providers to modify clinical procedures that would ultimately impact purchasing decisions. This is one of the many healthcare reform resources HIDA has developed. For more information on healthcare reform, visit www.HIDA.org/Reform, or contact HIDA Government Affairs at (703) 549-4432. DISTRIBUTION DISTRIBUTION STREAMLINING HEALTHCARE SM
• Comparative Effectiveness Research (CER) • Patient Centered Outcomes Research Institute (PCORI)2 CEF and the PCORI Research designed to inform healthcare decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options (that is, disease prevention, diagnosis, treatment, monitoring, and management). The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, and/or ways to deliver healthcare. 1 A non-profit, non-government entity established through healthcare reform to oversee CER funding and research priorities comprised of a 21-member board and 15-member methodology committee. The PCORI is comprised not only of researchers, but also clinicians, drug and device manufacturers, payers, and consumers. ¹ Agency for Healthcare Research and Quality (AHRQ). Effective Health Care Program. www.effectivehealthcare.ahrq.gov. ² Deloitte. Comparative Effectiveness Research in the United States: Update and Implications. July 12, 2011. DISTRIBUTION DISTRIBUTION STREAMLINING HEALTHCARE SM
4. Medical device/equipment • CER is projected to save $8 billion over ten years according to the Congressional package) included an investment of $1.1 billion Pre-Healthcare Reform Post-Healthcare Reform • CER is intended to improve the quality of care and clinical outcomes while What does CER have to do with healthcare reform? lowering the cost of care, also a key objective of healthcare reform Budget Office 5 The top five types of federally funded CER studies PCORI members appointed and established objectives for 20114: across 2006-2009 3 : 1. Conduct environmental scan to help determine where 1. Pharmacological treatment PCORI can add value and help establish national priorities 2. Delivery system 2. Develop planning grant process 3. Behavioral intervention 3. Establish PCORI national priorities 4. Develop durable Core Research Agenda for patient-centered 5. Surgical procedure outcomes research The American Recovery and Reinvestment Act 5. Identify and fund capacity-building research that will fill gaps (also known as the 2009 economic stimulus in research methodology to boost national CER efforts ³ Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and Congress. June 30, 2009. Page 34. 4 Patient Centered Outcomes Research Institute. Program Development Committee: Report to PCORI. March 7, 2011. 5 Congressional Budget Office. Budget Options Volume 1 Health Care. December2008. www.cbo.gov/ftpdocs/99xx/doc9925/12-18-HealthOptions.pdf. Page 86. DISTRIBUTION DISTRIBUTION STREAMLINING HEALTHCARE SM
• Encourage the cessation of current treatment options • Research outcomes are likely to: • Influence reimbursement decisions, and/or • Drive new product development • CER reports and research findings are not intended to be mandates, guidelines, nor policy recommendations • The PCORI does not have the authority to enforce its recommendations through • Guide provider best practices • Comparative effectiveness research could significantly impact patient and provider decisions about treatment options What does CER mean for your customers? financial penalties or otherwise However... DISTRIBUTION DISTRIBUTION STREAMLINING HEALTHCARE SM
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