There's no point in shutting the barn door if all the animals are already running around the farm. The same can be said for determining a certain medical procedure, which is almost universally covered by Medicare and private payers, to be ineffective. That's because there's a lot of power behind a coverage decision, making it very difficult to rescind.
According to a recent article published in the journal Health Affairs, payers should demand better evidence regarding whether a new treatment is effective before they decide to pay for it. The authors analyzed the effectiveness of percutaneous vertebroplasty, a common procedure to treat vertebral fractures, which has been covered by Medicare since 2001 and almost all private payers since 2007.
However, in 2009 the New England Journal of Medicine published the results of two studies, both of which concluded that vertebroplasty provided no greater pain relief than a sham procedure. More than two years later, payers still cover the procedure.
But why, you ask? The authors propose it's extremely difficult to change coverage policies based on "negative" research findings, which use sham-controlled studies to determine whether a procedure is ineffective for most or all patients. With these studies, there's almost always the possibility that some yet-identified subgroup of patients could benefit from the intervention.
Perhaps more problematic is that this scenario didn't seem like news to payers. Officials from Medicare, Aetna, UnitedHealthcare, and Kaiser Permanente told the authors that after covering vertebroplasty for so long, they feared any attempt to change their "yes" to a "no" would be publicly perceived as ending access to beneficial care. Essentially, the mere decision to cover vertebroplasties meant these procedures are effective. Messing with the status quo, therefore, would rock the worlds of providers, manufacturers, and patients with a vested interest in the procedure, potentially causing "massive disruption."
There's something very wrong with this picture. Payers shouldn't hold so much power to influence whether certain medical treatments or procedures are effective. But since they do have such a commanding presence in the health industry, I wish they would rely more on research to push back against any resistance to coverage decisions. They have no problem, for example, hiking rates to exceedingly high amounts in the face of public outrage, for which they generally offer limited facts and support. But they can't build a clear, evidence-driven case for reversing coverage based on new research? In both situations, payers stand to reap the financial benefits, so I don't understand the polar opposite approaches.
According to the article, payers said acting on negative studies is "much easier" when the safety of an intervention is called into question. "Ultimately, although payers believed strongly that coverage should be guided by high-quality evidence, the difficulty in using negative studies to build a case to restrict or deny access for all patients added to the inertia created by early coverage." Doing what's right, however, isn't always about taking the easy road. If solid research demonstrates that a procedure isn't worth a patient's risk of side effects or time in recovery--and that procedure incurs unnecessary costs--then it shouldn't be promoted through insurance coverage.
The authors challenged payers to help develop transparent and consistent standards for more rigorous evidence of a procedure's effectiveness before unrestricted coverage is granted. Insurers need to take a strong lead, they said, by requiring at least two high-quality randomized trials among patients generally representative of those who would be treated in practice.
Otherwise, the "vertebroplasty story is likely to be repeated." I hope payers heed their advice. - Dina (@HealthPayer)