* This following letter was sent to President Obama from Dr. Wini Hayes on March 25, 2009. It outlines her view of the challenges in the healthcare industry, as well as her recommendations to make best use of the new Federal funding for comparative effectiveness research.

Dear President Obama,

You asked the American public to share potential solutions for our current healthcare crisis. Thank you for opening this dialog and your willingness to listen in a nonpartisan manner. We will need all citizens to help improve America’s healthcare system.

I have worked in healthcare for nearly 40 years, as a nurse, an educator, a researcher, and in the healthcare business sector. Twenty years ago, I founded Hayes, Inc., a health technology assessment company that provides evidence-based research reports on new, emerging, and controversial health technologies to health plans, government agencies, hospitals, health systems, and consumers. We also provide consulting services to help these same constituents put our research into action to improve patient care and outcomes. Today, our clients serve over 200 million consumers and patients. In the interest of transparency and disclosure, I have a vested interest in the synthesis, dissemination, and application of the expanded base of clinical evidence that would be created under Stimulus Act funding provisions. As such, I am fully committed to improving the safety and quality of healthcare through decisions grounded in evidence. This is my passion, this is my mission, and I believe this is the cornerstone of any meaningful healthcare reform efforts.

With my front-row seat in healthcare, I have thought a lot about why our healthcare system lags other developed nations. The factors that follow, I believe, are among the most important:

• Failure to effectively and efficiently integrate scientific evidence into healthcare decision-making, resulting in overuse, misuse, and even (in some instances) underuse of health technologies.
• Insufficient and, in many cases, poorly designed and executed comparative effectiveness and cost-effectiveness research.
• Adoption of newly approved technologies before evidence supports it, which contributes to spiraling healthcare costs without commensurate improvement in patient care.
• Perverse financial incentives that drive premature dissemination of new medical technologies even when they do not improve patient care or outcomes.
• Lack of efficient and effective methods to keep clinical practitioners up to date on “best evidence” and “best practice” at the time of need.
• A consumer population that is largely overwhelmed with navigating the healthcare system and finding the right evidence-based resources to make the best healthcare decisions.
• Uneven and untimely healthcare access and quality.
• Continued erosion in employer-sponsored health insurance.
• Insufficient focus and allocation of resources to health promotion and disease prevention.

I believe that the comparative effectiveness funding provided for in the Stimulus Act will help to stem the tide of rising healthcare costs and will provide research that is sorely needed for payers, providers, and consumers to make better healthcare decisions. To maximize the impact of this funding, I believe your administration must focus on primary comparative effectiveness research. There are a number of private sector entities, including Blue Cross Blue Shield Association’s TEC Program, federally funded Evidence-based Practice Centers, and my firm, Hayes, Inc., that are already positioned to help payers, providers, and consumers synthesize existing and new evidence, and integrate the resulting conclusions into the healthcare decision-making process. If the Federal Government ultimately assumes the primary role for synthesis of evidence, it will short-circuit these private sector initiatives, add a layer of bureaucracy to the system, and politicize the process.

With this as a backdrop, the following are my recommendations to make best use of the new Federal funding for comparative effectiveness research and improve acceptance and buy-in from the healthcare community at large:

• Coordination and prioritization efforts of the Federal Coordinating Council for Comparative Effectiveness Research must include the private sector in setting the research agenda. Questions about which treatments, technologies, medicines, and procedures to compare are best posed by the hospitals, universities, manufacturers, consumers, providers, and private research organizations that are at the front lines of healthcare.
• Let the private sector determine how to put the resultant clinical evidence into practice. As noted above, the private sector has already made progress in accomplishing this and I encourage you to build on this base. Federal involvement in putting research results into practice will be seen as a form of rationing.
• Create an environment where providers and consumers have access to the best available clinical evidence. Federal support of the dissemination of comparative effectiveness and cost-effectiveness research findings, including digital and user-friendly ways to do so, is needed.
• Allow the private sector to respond to the improved evidence base in making healthcare decisions and avoid an expanded federal policy role that determines coverage and reimbursement beyond the current CMS structure. This approach will allow for public dialogue and solutions and will be less politicized and ultimately better accepted in the healthcare community.
• Encourage all healthcare-accrediting organizations to create standards that require the consideration of scientific evidence in healthcare decision-making. If a technology is adopted in spite of weak evidence, the standards should address a mechanism to evaluate the technology’s impact on patient safety, clinical outcomes, and comparative value, specifying patient indications and contraindications.
• Fund the creation of patient registries by the private sector. Consider incentivizing industry participation. Universal industry participation is essential if patient registries are to be successful.
• Facilitate public discourse around the meaning, role, and importance of clinical evidence, clinical significance, utility, comparative effectiveness, and cost-effectiveness as these terms relate to healthcare services, costs, benefits, and, ultimately, the choices we make.

Implemented in this manner, the additional funding for comparative effectiveness research provided in the Stimulus Act will eliminate many of the healthcare industry issues that I articulated at the start of this letter. I would welcome an opportunity to discuss these and other ideas and recommendations further and to support our healthcare reform efforts.

Sincerely,

Winifred S. Hayes, RN, MS, PhD
President and CEO