Is Comparative Effectiveness Research a Panacea for the US Healthcare System?
When President Obama signed into law the American Reinvestment and Recovery Act of 2009 (ARRA) back in February, one of the more significant – and controversial – healthcare-related measures was the appropriation for comparative effectiveness research (CER). For years, healthcare reformists expressed the need for head-to-head research to evaluate the clinical effectiveness, risks, and benefits of medical treatments and/or services in hopes of reducing medical costs while improving outcomes. But now that the money is available to fund this research, critics are moving fast to either praise the movement as a key aspect of domestic healthcare reform, or deride it as a potential threat to consumerism and private enterprise.
The Proposed Solution
Under the ARRA provisions, $1.1 billion has been allocated for CER to determine which drugs, devices, and procedures are most effective while carrying the lowest risk. To achieve this task, the bill established the Federal Coordinating Council for Comparative Effectiveness Research (FCC-CER) and delegates spending authority to the HHS Secretary to investigate the effectiveness of different drugs and medical devices. The research is intended to provide doctors and patients with useful information to achieve optimal healthcare outcomes and improve the performance of the U.S. healthcare system. The idea is that by providing a system of best practices for healthcare, we would be able to stabilize rising costs and generate savings for consumers and employers alike.
The Potential Risks
Comprised of 15 federal officials (at least half of whom are physicians or others with clinical expertise), the FCC-CER will be tasked with recommending and coordinating the research, but will not be able to establish clinical guidelines or mandate policies for payment, coverage or treatment. However, many opponents believe that such an agency can often negatively influence or override the professional judgment of a patient’s attending physician. The concern is that CER directed in this manner could pose a threat to the personal freedom of patients to be able to choose the care that their physicians believe is best for them. In addition, some fear that while the government is not mandating coverage decisions based on CER, health insurers may use the information to justify coverage preferences or potential denials of coverage.
Another major concern is its effect on technological innovations from the private sector and the potential to undermine medical advancements in a country that is also the largest producer of medical technology. An incentive structure that encourages providers to consider trade-offs between the costs and benefits of healthcare also offers little incentive to use expensive technologies, and thus, researchers will have little incentive to create them. Further, unfavorable CER ratings could hamper the sales of new drugs that may be considered only marginally better than the standard of care, and in turn, cease the necessary development that could lead to breakthrough medications.
The European Model
While the U.S. takes a significant step into standardizing government-sponsored CER, a model program has already existed in Europe for a full decade. In 1999, the British National Health Services created the National Institute for Health and Clinical Excellence (NICE) to evaluate treatments and drugs while recommending whether or not the NHS should pay for them. NICE has made significant progress in creating standards for the British healthcare system, and its measurement of cost effectiveness known as quality-adjusted life year (QALY) has been used all over Europe.
By no means is NICE considered a perfect system for improving healthcare costs through CER, but it does increase cost transparency and promotes alternative assessment principles aimed at making people better healthcare consumers. Although the cost savings of CER practices are difficult to measure, it is important to note that CER can positively affect healthcare on the consumer level – and that would go a long way toward steering our own healthcare system in the right direction.
Conclusion
For the most part, CER done under the right conditions can shed light on the effects and costs of various forms of health technology while comparing the efficacy of one treatment option over another. However, it remains to be seen whether the benefits of the CER solutions funded in the ARRA will outweigh the potential effects on the free consumer market and the healthcare innovations brought about by private industry. Also, the debates about whether CER should be conducted by the government or by the private sector will continue as neither side can be truly unbiased in the process. Yet, despite the controversy, the opportunity now exists to create a better understanding of the effectiveness of health technology – and it is up to the U.S. healthcare system as a whole to make the most of it.
For more information, please click on the links below…
Obama Healthcare Plan Relies on the Evidence
Comparative Effectiveness in Healthcare Reform: Lessons from Abroad
Comparative Effectiveness Research as Patient Education Tool
Comparative Clinical Effectiveness Research: How Will It Impact Healthcare?
The Attack on Government Funded Comparative Effectiveness Research
UK’s NICE Sheds Light on Comparative Value
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Important Notice: Hill, Chesson & Woody does not engage in the practice of law, accounting, or medicine. Therefore, the contents of this communication should not be regarded as a substitute for legal, tax, or medical advice.
April 9, 2009
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