HEALTHCARE REFORM Comparative Effectiveness Research (CER) - - PowerPoint PPT Presentation

STREAMLINING HEALTHCARE

DISTRIBUTION DISTRIBUTION

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.

STREAMLINING HEALTHCARE

DISTRIBUTION DISTRIBUTION

CEF and the PCORI

• Comparative Effectiveness Research (CER)

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

• Patient Centered Outcomes Research Institute (PCORI)2

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.

STREAMLINING HEALTHCARE

DISTRIBUTION DISTRIBUTION

What does CER have to do with healthcare reform?

• CER is intended to improve the quality of care and clinical outcomes while

lowering the cost of care, also a key objective of healthcare reform

• CER is projected to save $8 billion over ten years according to the Congressional

Budget Office5

Pre-Healthcare Reform

The top five types of federally funded CER studies across 2006-20093:

• 1. Pharmacological treatment
• 2. Delivery system
• 3. Behavioral intervention
• 4. Medical device/equipment
• 5. Surgical procedure

The American Recovery and Reinvestment Act (also known as the 2009 economic stimulus package) included an investment of $1.1 billion to boost national CER efforts

Post-Healthcare Reform

PCORI members appointed and established

• bjectives for 20114:
• 1. Conduct environmental scan to help determine where

PCORI can add value and help establish national priorities

• 2. Develop planning grant process
• 3. Establish PCORI national priorities
• 4. Develop durable Core Research Agenda for patient-centered
• utcomes research
• 5. Identify and fund capacity-building research that will fill gaps

in research methodology

³ Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and Congress. June 30, 2009. Page 34.

STREAMLINING HEALTHCARE

DISTRIBUTION DISTRIBUTION

What does CER mean for your customers?

• 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

financial penalties or otherwise However...

• Comparative effectiveness research could

significantly impact patient and provider decisions about treatment options

• Research outcomes are likely to:
• Guide provider best practices
• Drive new product development
• Influence reimbursement decisions, and/or
• Encourage the cessation of current treatment options