Over the course of the last decade the buzz around stem cell therapies has begun to pick back up. These radical treatments aim to cure anything from chronic joint pain to degenerative heart, brain, and bone illnesses. While much clinical work is left to be done, the question on most of our patients’ minds when they enter the CELLAXYS facility is “Are stem cell therapies covered by insurance?”
Well, the short answer is no, but there are instances where there may be some kind of coverage.
Background: Stem Cell Therapies in the US
While stem cell treatments have been around for several decades, it was only in the past 15 years that researchers discovered a way to induce a stem-cell-like state in healthy adult tissues. This discovery led to a less ethically ambiguous source for stem cells and reignited the scientific community’s interest in stem cell treatments.
This new method of deriving stem cells takes blood, fat, or bone marrow from an adult and induces an infantile state in the tissues which allows them change into various other tissues in the human body. The new cells created through this process are known as Induced Pluripotent Stem Cells.
Worldwide, Induced Pluripotent Stem Cells, or IPSCs as they’re more commonly known, have garnered a lot of praise from medical and scientific communities alike. Specifically, Germany and Japan are at the forefront of the development of therapies around IPSCs, while the US is quickly lagging behind.
Treatments using IPSCs are fairly new to the US and are still undergoing the rigorous approval process by the FDA. So, while other countries have begun to approve the application of these treatments nationwide, in the US, laboratories are still culling their data in order to prove that such medicines are safe and effective by US standards.
Stem Cell Therapies, the FDA, and Insurance Companies
Many argue that because stem cell treatments are approved in other developed countries, the US should aim to replicate those processes here and do away with the prolonged FDA approval process or be left in the wake of massive discoveries in the years to come.
The push for approval has been so strong that recently, the FDA has approved a seemingly less complicated way to get its approval.
In most cases, treatments undergo several years of clinical trials and may cost millions of dollars before gaining the FDA’s blessing. While these measures help ensure patient safety and treatment efficacy, they are also quite daunting for privately owned clinics to process.
As a response to these concerns, the FDA has begun allowing clinics to pool their data together and present it jointly in order to gain the authorization to apply such treatments with FDA approval.
These measures come with a 36-month grace period which allows clinics participating in these studies to continue operations. Thus, clinics specializing in stem cell therapies are technically allowed to operate in the US, albeit without FDA approval for their treatments.
And it is with this FDA approval that insurance actually comes into play. Without FDA authorization, it is very difficult to get on the short list of sanctioned treatments by most insurance companies, and if a treatment isn’t sanctioned by a person’s insurance, then they will most likely not get reimbursed for the treatment.
Still, there may be ways around this dilemma. For instance, some privately owned insurance companies will reimburse patients for non-FDA approved treatments if physicians decide the treatment has enough supporting evidence to merit reimbursement.
In other cases, clinics may offer stem cell treatments under a different name which has been sanctioned by the FDA. In these cases, the clinic will more than likely call the treatment a “fat-injection” and will use the injection to treat joint pain. These injections, while technically being derived from fat, are in fact IPSCs which have been isolated from the fat tissue.
So, while most insurance companies will not approve stem cell therapies, there may be ways to circumvent the insurance policies in order to get reimbursed for these treatments. In order to get a more accurate picture, it is best to talk to your insurance company, a clinic specializing in stem cell therapy, or your family doctor.
Stem Cell Therapies, What the Future Holds
While most stem cell therapies have not yet been approved by the FDA (and are thus not sanctioned by most insurance companies), research around the subject in the US is rapidly developing and strides are being made for universal acceptance of such treatments.
In fact, the FDA has already begun to approve some of the products being clinically tested as part of their new regulations. A list of such products can be found here, on the FDA’s website.
Some forms of stem cell treatment have even been approved. Stem cell therapies such as those for leukemia are already FDA sanctioned and covered by most medical insurance companies.
Additionally, US clinical trials of stem cell therapies are at an all-time high. Treatments are being tested for a range of issues, from kidney disease, to osteoarthritis, and beyond. Similar treatments have already undergone the clinical and approval process in other countries and been accepted as safe and effective, so the outlook for these US trials is mostly positive.
Though these processes are all indicative of rapid interest and acceptance of these treatments, none is more promising than the strides being made in the private insurance sector. According to the Employee Benefit Research Center (EBRC), over half of the US workforce insured through their employer fall under such plans.
The benefit to these types of plans over large, subsidized insurance policies, is that they have the power to decide which treatments shall receive reimbursement on a case by case basis. With this in mind, employees have a much wider range of options available to them for their particular medical issue, including stem cell treatments.
The same EBRC article indicates that private health insurance is a growing trend and that many small, privately owned clinics (such as CELLAXYS) are marketing their services to these employer-provided insurance policies and rapidly gaining approval for reimbursement. Thus, while most US citizens may not have the luxury of applying stem cell therapies to their particular issue, the number of insurance policies accepting these new treatments is steadily rising.
If you would like more information about stem cell treatments or need help determining if your insurance policy may cover such treatments, contact the CELLAXYS offices today.