An article recently published in Health Affairs examines the literature on percutaneous vertebroplasty and questions whether payors have appropriately adapted to new findings in the comparative effectiveness research to provide better patient outcomes at a lower cost.
Medicare began covering percutaneous vertebroplasty in 2001, with other payors following not far behind. These payors continue to reimburse for the procedure, despite two randomized studies published in a 2009 edition of the New England Journal of Medicine showing that vertebroplasty provided no benefits over a sham procedure for pain relief, according to the report. The report authors examined policy documents related to the articles and conducted further discussions with policy leaders to describe reaction to these studies.
The report details a timeline of vertebroplasty performance and coverage, as well as describing study outcomes. While the study's authors recognize the potential "weakness" of the NEJM studies, it also describes the Vertos II study, which found vertebroplasty effective compared to pain medication, as having a "risk of bias as a consequence of the lack of a sham procedure as a realistic placebo."
Researchers suggest that the Patient-Centered Outcomes Research Institute, created by Patient Protection and Affordable Care Act in 2010, could provide a structured body to interpret and apply evidence-based medicine to clinical coverage guidelines.
The article finishes by making policy recommendations for interpreting negative evidence and applying it to healthcare coverage:
• Strengthen evidence requirements to avoid broad coverage without strong evidence of clinical benefit
• Work with clinicians and patients for better research designs
• Reward evidence-based practice instead of just procedure volume
• Support a national structure for generating and assessing evidence, which could be PCORI
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The report details a timeline of vertebroplasty performance and coverage, as well as describing study outcomes. While the study's authors recognize the potential "weakness" of the NEJM studies, it also describes the Vertos II study, which found vertebroplasty effective compared to pain medication, as having a "risk of bias as a consequence of the lack of a sham procedure as a realistic placebo."
Researchers suggest that the Patient-Centered Outcomes Research Institute, created by Patient Protection and Affordable Care Act in 2010, could provide a structured body to interpret and apply evidence-based medicine to clinical coverage guidelines.
The article finishes by making policy recommendations for interpreting negative evidence and applying it to healthcare coverage:
• Strengthen evidence requirements to avoid broad coverage without strong evidence of clinical benefit
• Work with clinicians and patients for better research designs
• Reward evidence-based practice instead of just procedure volume
• Support a national structure for generating and assessing evidence, which could be PCORI
Related Articles on Spine Care:
Study: Cervical Disc Arthroplasty Better Than ACDF for Cervical Disc Disease
UC Davis Researchers to Inject Stem Cells for Back Pain Relief
Where Spine Research is Headed: 5 Points From Dr. Frank Phillips