FDA more receptive to ‘cold caps’ – but is your insurer?
I guess we could either say, “Good work, FDA” or “What the heck took you so long?”
At the beginning of the month, the agency approved another use for what’s called a “cold cap,” a way for chemo patients to keep more — sometimes most — of their hair while undergoing treatments.
Despite the fact these caps have been available in Europe for quite a while, it wasn’t until two years ago that the FDA gave the first okay to the DigniCap Cooling System for those with breast cancer. Then, this April it approved one called the Paxman Scalp Cooling System.
Now, the FDA has expanded the DigniCap use to “solid tumor” cancer patients, which include cancers such as carcinomas, lymphomas, and sarcomas.
And while the burden of paying for these caps often falls on the patient, what this new FDA approval should do is help more of them get the treatment covered by their insurance.
That is… should.
Chilling out
Traci Peltz knows full well how keeping her hair during chemo for breast cancer helped in her recovery.
The Ohio woman’s doctor was the one who first told her about cold caps, but she was turned down for coverage by her insurance, which is something that happens all too frequently. So she and her husband Ed paid the $500-per-month rental fee — plus the cost of dry ice — out of their own pocket.
That’s how important it was for Traci not to be wearing a wig at her daughter’s wedding.
And it worked! She was able to keep most of her hair during chemo treatments.
Now, Traci and Ed are doing everything in their power to make sure as many women as possible know about this head-cooling, hair-saving system.
The idea behind cold caps is to protect hair follicle cells from chemo damage by means of a tight-fitting, super-chilled cap that you wear during treatments. It constricts blood vessels to limit the amount of chemo drugs that reach the scalp.
The difference between them is basically how easy they are to use and the temperature they maintain. DigniCap contains a coolant that circulates throughout the cap and doesn’t fall below freezing (32 degrees Fahrenheit). Other types use dry ice, with patients needing to change the cap several times during treatments or chill them manually to get them much colder.
The kind Traci used, for example, went down to 25 to 30 degrees below zero! One doctor describes the sensation as being like “jumping into a pool where it’s very cold for the first 15 minutes, but then you get used to it.”
But the real question here isn’t whether or not it works, since it quite obviously does. Rather, it’s how to get your insurance to cover it.
And that all might boil down to how your doctor fills out the paperwork.
If your insurance covers wigs, which many do, the same insurance code as one for “cranial prosthesis” needs to be used. That might just do the trick.
If not, contact your company and ask why you were turned down. People often have decisions reversed just by doing that.
Other problems patients have encountered include finding a cancer treatment center that uses the caps — which was exactly what Traci and Ed discovered. It turns out that it’s not available in most medical facilities in many parts of Ohio (including Cleveland).
Perhaps with this new FDA nod to the cold-cap concept, more hospitals will offer them to patients. But even if that’s not the case, you can, with your doctor’s OK, rent or buy one on your own and bring it with you (along with a cooler and dry ice).
And while cold caps are mostly used by women, there’s no reason why men undergoing chemo shouldn’t take advantage of the chance to beat hair loss as well.
“FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy” FDA News Release, July 3, 2017, fda.gov


