Laws meant to prevent the overuse of expensive healthcare services don't stop doctors from using pricey prostate cancer treatments, according to two new studies.
Researchers found doctors used robots and special radiation to treat prostate cancer regardless of whether their area had laws requiring government approval before money is spent on healthcare facilities and new equipment.
"Certificate of need laws were designed to align public need with use of different services," said Dr. Bruce Jacobs, a lead author of one of the studies from the University of Michigan in Ann Arbor.
The U.S. government required states to implement the laws in the 1970s and early 1980s, but stopped a few decades ago. Still, some states continue to use the laws in an effort to control costs.
In each study, the researchers looked at treatments for prostate cancer, which is the most common cancer in American men.
The American Cancer Society estimates that one in every six men will be diagnosed with prostate cancer in their lifetime, but most will not die from it. Past research found that many men's prostate cancer is slow-growing, and most are candidates for active surveillance or "watchful waiting."
In Jacobs's study, the researchers looked at whether states with strict laws - those that require approval for even low-cost equipment - used robotic surgery to remove fewer prostates than states with less strict or no laws.
Jacobs and his colleagues write in The Journal of Urology that the price of such robots, and the questions surrounding whether or not robotic surgery to remove a prostate is better than the old-fashioned way should make it an "ideal target" for review under the laws.
In September, for example, one of the studies that have questioned the usefulness of robotic surgery found that men who had robotic surgery ended up having fewer short-term complications, but questioned its long-term benefits and whether the hefty price tag of $1.5 million in startup costs is worth it. (see Reuters Health article of Sep. 12, 2012:)
But another recent study found robotic surgery led to fewer complications, fewer readmissions to the hospital, and fewer deaths due to surgery than traditional methods, according to Intuitive Surgical, the maker of the da Vinci Surgical System.
"That is significant for the patient and for reducing overall costs to the system," wrote Angela Wonson, a spokesperson for Intuitive Surgical, in an email to Reuters Health.
Overall, in the new study, the use of robotic surgery to remove prostates in Medicare patients increased regardless of whether there were strict, less strict or no laws in place. Also, the chance a surgeon used robots had nothing to do with the laws.
Radiation and costs
A second study by another group of researchers looked at whether the laws limited the use of intensity modulated radiation therapy (IMRT) or slowed the growth of healthcare costs related to prostate cancer.
IMRT allows doctors to focus radiation beams onto the cancer without harming healthy tissue.
However, the researchers write that IMRT is costly and - to their knowledge - has not been compared to other prostate cancer treatments in a randomized controlled trial, which is considered the "gold standard" of medical research.
In a group of Medicare patients, Dr. Ganesh Palapattu, the chief of urologic oncology at the University of Michigan and the study's senior researcher, found that areas with the laws actually saw greater growth in IMRT use.
Palapattu and his colleagues found that IMRT use increased from about 2 percent of all prostate cancer treatments in 2002 to almost half in 2009 in areas with the laws.
In areas without the laws, IMRT use increased from about 11 percent of all prostate cancer treatments to about 42 percent over the same time span.
The laws also didn't seem to help control prostate cancer treatment costs when the researchers compared the price to treat one person with prostate cancer in states with laws, compared to states without laws.
Palapattu told Reuters Health that it may be time to reevaluate the regulations.
"If the goal is to limit the overutilization of more expensive therapies and to improve efficacy or health, then we have to reexamine how we're doing this," he said.
Jacobs told Reuters Health that there is more research to be done, because his group's study did not look at how many applications for equipment may have been turned down by the states' approval board.
"I think if we really want to get to the bottom of how effective these (laws) are, the next step is to really look closely at each state's process of review," he said.
Palapattu said he'd also like to see if the findings are the same for non-Medicare patients. But, for now, he said men with prostate cancer should talk to their doctors about which treatment is right for them.
"Newer isn't always better, and it's important to have a meaningful conversation with your physician on treatment options and which one might be best for you and why," he said.