A 2008 paper by Timothy Wilt MD at the University of Minnesota published by the Agency for Healthcare Research and Quality illustrates the problem.
Wilt referenced cryotherapy, laparoscopic or robotic-assisted radical prostatectomy, primary androgen deprivation therapy, high-intensity focused ultrasound (HIFU), proton beam radiation therapy, or intensity modulated radiation therapy (IMRT), saying "It is not known whether these therapies are better or worse than other treatments for localized prostate cancer because these options have not been evaluated in randomized clinical trials."
Bach and Pearson acknowledge companies that design new medical technologies and go through an expensive regulatory process to get them approved might be upset. They'd think they were no longer guaranteed high rates of reimbursement for their efforts, and innovation would be stifled.
But innovation would not be stifled, Bach says, because drug and device makers would get three years to prove the superior merits of their products compared with other standards of care.
"Medicare could help enable this by taking the view that, for some period of time, the introducer of the new product gets a chance supported by the government to prove superiority," Bach says. "Failing that, we and the taxpayer and (Medicare) beneficiary shouldn't be paying more for the new thing than the old thing if they're equivalent."
The authors acknowledge an important downside. In this new era where new care services get tested for effectiveness, they might only be available first in academic settings equipped to conduct such trials. "Patients in rural areas and others without ready access to academic sites might have less access to newly covered services," they wrote.
But that's a justifiable trade-off, they believe. Remember, they caution, these are services to be reimbursed at reference-price levels or at usual levels during a trial period are services lacking evidence to demonstrate that they are better than other options," they wrote. In fact, any new evidence could show that they are actually worse.