Stem Cell Q&A: Is Stem Cell Treatment Covered by my Insurance?
Posted at 1:30 PM on Jun 21, 2018
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With any medical treatment, there’s always the question of whether your insurance company covers the procedure. Insurance policies will not cover treatments they consider experimental. By experimental, they mean procedures or treatments that raise concerns over harmful effects and/or unproven benefits. Insurance companies consider most instances of stem cell therapy to be experimental and will not cover the costs.
In the early days of stem cell research, there were a lot of concerns over stem cell therapies and the possible effects on cancer or other disorders. These assertions have since been proven to be extremely inaccurate. Countless studies have examined the effects of injecting platelet-rich plasma and stem cells into ideal candidates for a number of years with no harmful results.
While Insurance companies generally do not pay for stem cell treatments, they may pay for your consultation with the doctor and other associated costs that are incurred during the procedure. Patients treated at the Twin Cities Pain and Regenerative Medicine facility in Edina, Minn. will get a full and transparent accounting of all costs and what is expected in payment before any stem cell or regenerative medicine treatment.
About Twin Cities Pain and Regenerative Medicine
Twin Cities Pain and Regenerative Medicine leads the industry in the Minneapolis and Upper Midwest areas in resolving chronic pain through stem cell treatments. Medical Director Dr. Constantin Starchook has two decades of experience as an anesthesiologist in the Twin Cities and has been on the forefront of regenerative medicine for years.
If you’re tired of dealing with chronic aches and pains, think twice before getting a risky surgery that could lead to more pain. No one should have to deal with the stress of considering an invasive surgery to treat pain that could be remedied with stem cell treatments.. Contact us today for a minimally invasive alternative to surgery to treat your chronic pain.
Original Medicare and Medicare Advantage plans both cover certain types of approved stem cell therapy.
Medicare parts A and B, also known as original Medicare, provide coverage for approved stem cell treatments and the associated out-of-pocket costs. However, coverage varies between the different Medicare options.
The purpose of Food and Drug Administration (FDA)-approved stem cell therapy is to restore normal blood production and development in a person whose body has lost this function.
This article discusses this type of stem cell therapy, examines the coverage and costs of each part of Medicare, and describes the specific procedures that Medicare covers. It also looks at the costs of inpatient stem cell therapy for people who do not have Medicare.
We may use a few terms in this piece that can be helpful to understand when selecting the best insurance plan:
- Deductible: This is an annual amount that a person must spend out of pocket within a certain time period before an insurer starts to fund their treatments.
- Coinsurance: This is a percentage of a treatment cost that a person will need to self-fund. For Medicare Part B, this comes to 20%.
- Copayment: This is a fixed dollar amount that an insured person pays when receiving certain treatments. For Medicare, this usually applies to prescription drugs.
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Stem cell therapy with Original Medicare
Medicare covers part of the costs of two types of FDA-approved stem cell therapy or transplants. The coverage applies to transplants, whether doctors perform them as an inpatient or an outpatient procedure.
Medicare Part A, which is hospitalization insurance, covers inpatient transplants. However, Part A pays only for admissions that fall under a regulation called the Two-Midnight rule. According to this rule, the admitting doctor expects a person to require a stay in a hospital for at least two midnights.
Although Part A is generally not appropriate for shorter hospital stays, Medicare may grant coverage on a case-by-case basis, depending on the admitting doctor’s judgment.
The cost associated with Part A is a $1,484 deductible. There is a $0 coinsurance for the first 60 days of a hospital stay.
Part B, which is medical insurance, covers outpatient transplants that healthcare professionals consider medically necessary.
The yearly deductible of $203 applies. Once a person meets the deductible, they usually pay 20% of the Medicare-approved amounts for doctor services and other costs involved in the therapy.
Stem cell therapy with Medicare Advantage
Medicare Advantage provides the coverage of parts A and B, while most plans also include prescription drug coverage.
Private insurance companies administer Medicare Advantage policies, and because of this, the out-of-pocket costs are different from those of original Medicare.
Out-of-pocket costs may also vary among plans, but all policies have a yearly cap on expenses. Additionally, an individual with Medicare Advantage must go to an in-network provider.
Stem cell therapy with Medigap
Medigap is Medicare supplement insurance. People who have original Medicare may buy a Medigap plan, which helps them pay out-of-pocket costs associated with parts A and B. The costs that this plan generally covers can include:
- deductibles
- copays
- coinsurance costs
Stem cell therapy with Part D
Someone with original Medicare is eligible to enroll onto a Part D plan for prescription drug coverage that would include medications needed for stem cell therapy. Part D deductibles, copayments, and coinsurance costs vary according to the policy a person has purchased.
Types of stem cell therapy Medicare covers
Medicare covers only two procedures: allogeneic hematopoietic stem cell transplantation (Allo-SCT) and autologous stem cell transplantation (Au-SCT).
Allo-SCT
In Allo-SCT, a healthcare professional will deliver healthy donor stem cells to a person through an IV infusion. The purpose is to restore normal blood production in someone whose body cannot perform this function.
A candidate for the transplant may be an individual with a deficiency in blood production, which can either be an inherited or acquired deficiency. An example could be a person with severe aplastic anemia.
Before the transplant, an individual will receive treatment to weaken the immune system — such as chemotherapy, radiation therapy, or both — so their body will not reject the donor cells. This treatment also allows the donor cells to reach the bone marrow, where they grow and make new blood cells.
With this procedure, there may be complications, which include rejection of the donor cells, despite the treatment to weaken immunity. Another possible complication is that the donor’s immune cells may attack a person’s healthy cells.
In addition to helping the beneficiary with costs, Medicare also assists the donor with costs. Covered donor expenses include doctor services, hospital care, and follow-up care.
Au-SCT
An Au-SCT procedure restores stem cells without the help of a donor. The transplant aims to enable the body to resume blood production and development after the organs and tissues sustain damage.
Candidates for the transplant include those with blood cancers, such as lymphoma or leukemia.
Before an Au-SCT transplant, a health professional will remove a person’s stem cells and freeze them. Afterward, the individual will receive high-dose chemotherapy with or without radiation therapy. The healthcare professional then returns the collected stem cells to the body.
If the procedure is successful, the transplanted cells make new blood cells within the bone marrow.
Au-SCT has a higher relapse rate than Allo-SCT, but Au-SCT does not carry the risk of a healthy cell attack because it does not involve donor cells.
Stem cell therapy cost
Stem cell therapy can be very expensive. A 2017 study examined the costs of 1,562 people who had inpatient Allo-SCT or Au-SCT between 2010 and 2013. The researchers discovered that the costs for these treatments ranged between $140,792 and 289,283.
However, the costs in the study were from claims individuals made to private health companies rather than to Medicare. The research also did not provide an estimation of the outpatient costs of stem cell therapy.
Summary
People with Medicare are eligible for coverage of two types of stem cell transplants. Candidates for these therapies may include individuals with a blood disorder, such as aplastic anemia, or someone with blood cancer, such as lymphoma.
If a person has original Medicare, they can enroll onto a Medigap plan, which helps with out-of-pocket expenses. An individual with a Medicare Advantage plan will have out-of-pocket costs that differ from those of original Medicare.
Note that stem cell therapy is costly. Before undergoing one of the transplants, a person may wish to check their Medicare plan to get an estimate of both covered and out-of-pocket costs.
Over the last decade, the buzz around autologous stem cell therapies has begun to pick back up. These innovative 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?”
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 embryonic stem cell treatments have been around for several decades, it was only recently that researchers discovered a way to induce a stem-cell-like state in healthy adult cells. 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, adipose (fat) tissue, or bone marrow from an adult and induces an infantile state in the tissues which allows them to 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, have garnered a lot of praise from medical and scientific communities alike. Germany and Japan are at the forefront of the development of therapies around IPSCs, while the US is quickly gaining pace.
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, in the US, laboratories are still demonstrating their data 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 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 recently that the FDA has enabled 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 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 autologous 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 comes into play. Without FDA authorization, it is very difficult to get on the shortlist 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 autologous 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 are IPSCs that have been extracted from adipose (fat) tissue.
While most insurance companies will not cover stem cell therapies, there may be methods to get around these limits and receive reimbursement for these procedures.
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.
The Future of Autologous Stem Cell Therapies
While most stem cell therapies have not yet been approved by the FDA, research around the subject in the US is rapidly developing and strides are being made for universal acceptance of these treatments.
The FDA has already begun to approve some of the products being clinically tested as part of their new regulations.
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 have 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 targeted 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.
If you would like more information about autologous stem cell treatments or need help determining if your insurance policy may cover these treatments, contact the CELLAXYS offices today.
