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Comparative Effectiveness: From Theory to Practice

The Institute of Medicine (IOM) has also joined the call for establishing greater evidence for orthopaedic procedures. Some of the funding for CER in the American Recovery and Reinvestment Act (ARRA) of 2009 went to the IOM to establish a list of 100 priority areas for research. Included in the IOM’s list were recommendations to:

  • Establish a prospective registry to compare the effectiveness of treatment strategies for low back pain without neurological deficit or spinal deformity
  • Compare the effectiveness of treatment strategies (e.g., artificial cervical discs, spinal fusion, pharmacologic treatment with physical therapy) for cervical disc and neck pain

There are signs that the above drivers of CER are already exerting influence in orthopaedics. The Agency for Healthcare Research and Quality (AHRQ), the health research arm of the Department of Health and Human Services, awarded a grant to the Professional Society Coalition on Lumbar Fusion Outcomes to assemble a multi-stakeholder meeting to provide the foundation for a prospective registry of treatment modalities for spinal conditions. The Coalition includes representatives from all major spinal professional societies, including the American Association of Neurological Surgeons, the Congress of Neurological Surgeons, the Scoliosis Research Society and the North American Spine Society. The coalition is developing consensus on a framework for conducting CER in spinal conditions, including choice of outcome measures and overcoming the legal, financial and technical hurdles to such research.

Over the next few years, as Federally funded projects in orthopaedics are awarded and completed, this comparative data will enter the public realm.

Events at the Federal Level

These questions about the efficacy and appropriateness of orthopaedic procedures are being raised at a time of growing financial pressures on Federal healthcare spending. Total healthcare spending, which accounted for about eight percent of the U.S. economy in 1975, currently accounts for about 16 percent of gross domestic product. This share is projected to reach nearly 20 percent by 2016, absent any changes in payment or coverage.4

Over the long term, rising health care costs will be the single greatest contributor to government spending deficits. About half of all healthcare spending in the U.S. is publicly funded. In an attempt to gain control over these spiraling costs, Congress has looked to comparative outcomes assessment as a way to set spending priorities.

  • ARRA funding allotted $1.1 billion for CER
  • The health reform legislation established an ongoing national program in CER: the Patient-Centered Outcomes Research Institute, that will receive about $500 million per year starting in 2014
  • Healthcare reforms have also funded pilot projects in Medicare to link payment to outcomes

National policy experts have proposed incorporating CER into Medicare payment by encouraging Medicare to pay equally for treatments that offer comparable outcomes. Thus, new technologies would not be able to command premium reimbursement unless the treatment could be proven to provide superior outcomes.5

A View from the States

Under the new healthcare law, an additional 40 million Americans will now be covered, mostly through the expansion of Medicaid programs. This increase in Medicaid enrollment is coming at a time when states are facing a $137 billion shortfall over the next two years. As pointed out by the National Governor’s Association (NGA), the countercyclical nature of Medicare expansion stresses state budgets as each one percent increase in the national unemployment rate is associated with an additional one million Medicaid recipients.6

Spending on Medicaid grew by 7.9 percent in 2009 and now accounts for 22 percent of state budgets. The NGA predicts a 21 percent increase in the number of Medicaid enrollees from 2008 to 2011. Covering these additional Medicaid enrollees will require $20 billion more over the next decade, according to the Congressional Budget Office.7 The CBO states that Medicare spending per enrollee continues to rise sharply, as well, primarily driven by the spreading use of new medical technology.

With millions of new recipients and with the costs per enrollee spiraling upwards, states will inevitably try to restrict coverage where possible. One model that other states may emulate is the Health Technology Assessment (HTA) committee established in the state of Washington. This group, comprising physicians and healthcare experts, reviews the available evidence on new technologies to determine not only the safety and efficacy, but the cost effectiveness of devices and procedures, as well. The committee then recommends whether the state should cover the technology fully, cover it under certain conditions or deny coverage entirely. Public payers in Washington must follow any recommendation made the HTA committee.

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