The medical research field is more vibrant than it has ever been. New and innovative treatment methods are being developed every day to combat some of the most challenging conditions that patients face. Such treatment methods are often the only option available for patients who have significant health complications that have plagued them for many years.
However, the reality is that innovative treatment methods are expensive. When compared to more established options, innovative procedures may not be backed by conclusive results or peer reviewed clinical evidence. In addition, such procedures tend to be more random in terms of their success rate and safety standards.
Even if an experimental treatment is your only available option, it’s not uncommon for insurance companies to deny claims for coverage. Insurers are often hesitant because these new and innovative techniques can be expensive with no guarantee for success. There are also cases where insurers wrongfully categorize a regular procedure as being experimental in nature.
Regardless of these concerns, denying someone treatment based on experimental grounds may result in a lifetime of poor health and even death as a result of one’s condition. Therefore, filing an appeal for such a denial is important. If the treatment method in question is backed by reasonable evidence, effectiveness, and safety standards, insurance companies have a fiduciary duty to honor such a claim.
What is an Experimental Treatment Denial?
The working principle behind insurance companies is supposed to be simple: you pay premiums, and your insurer offers coverage for the cost of treatment when you need it. However, complications arise when insurance companies determine if a treatment is medically necessary or not.
To cover their bases, insurers try to limit their liability for coverage. This includes avoiding claims that involve innovative treatment options not backed by established evidence. As a result, insurance companies may end up taking a blanket approach when denying claims for experimental treatment (without considering the needs of their patients).
It’s important to understand what an experimental or investigational treatment is so you can prepare a convincing appeal if you were to be denied treatment. By definition, an “experimental or investigational” treatment is any treatment, therapy, drug/drug usage, or procedure that is non-FDA approved and is not recognized by generally accepted medical standards. The definition also extends to procedures that are not classified as being safe or effective enough to treat a particular medical condition, illness, or injury.
In general, most FDA-approved procedures, which are also generally accepted by medical professionals, should be covered. A denial for such a procedure is strong grounds for appeal. Even more concerning is that various cancer treatments, organ transplants, and surgeries may be life saving for patients but fall under the “experimental or investigational” definition.
How to Determine If A Procedure Is Experimental or Not
If your doctor has suggested a particular procedure as a treatment for your health condition, you may be wondering whether the procedure falls under the experimental definition.
Despite the definition given above, there is little consistency among health insurers in defining an experimental treatment. Some insurers may classify a procedure as being standard, while others may frequently deny coverage for the same treatment option.
There are several guidelines you can use to determine if a particular treatment is experimental in nature. Some of these guidelines include:
The procedure is not approved by relevant government agencies (such as the FDA).
The procedure is not sufficiently peer reviewed or generally accepted by medical practitioners.
There isn’t sufficient evidence backing the safety and medical benefits of the procedure.
There isn’t sufficient experience regarding the nature of the procedure.
While these general guidelines can help you determine whether an anticipated procedure is experimental in nature, the final say lies with your insurance company. Some insurers are lenient when it comes to procedures that could potentially benefit a patient, while others may use a blanket approach to deny coverage for such treatment. This is why it’s important to file an appeal if you’ve been denied coverage for a claim.
Why Denials for Experimental Treatment May Occur
When you think of how insurance works, you maybe baffled as to why denials for treatment may occur. Remember that many insurance companies are out to make a profit, and they wouldn’t wish to spend lots of money on an innovative treatment option with unknown results. Simply put, experimental and investigational treatment procedures are viewed as being of high risk and potentially limited reward. This is primarily why health insurers avoid coverage for such procedures.
For any insurance company, predictability is a key part of their operations. They prefer providing coverage for treatment options that have been established by medical science, approved by governmental agencies, and determined beneficial to patients. If any medical procedure doesn’t meet these standards (even if it’s being carried out by a licensed medical professional), insurers will be hesitant to provide coverage.
In some cases, an innovative treatment method may not be the best option available for a patient. There may be other more established alternatives available when seekingtreatment. Therefore, insurers may prefer to cover these treatments as opposed to others that are more experimental in nature. Insurers may also fear the possibility of facing a larger claim if an experimental technique goes wrong. For example, cases where side effects or surgical complications arise, may cause a patient to require further treatment and coverage costs.
In a nutshell, most health insurers will carry out a cost-benefit analysis when it comes to coverage. They will determine if a specific procedure justifies its cost before extending coverage.
Is It Legal for Health Insurers to Deny Treatment for Experimental Procedures?
Coverage for a particular condition will be primarily determined by the contract you signed with your insurance company. There are many cases where patients have been legally denied coverage for experimental procedures based on the insurance contract. If the contract clearly defines and excludes certain experimental techniques from its policy coverage, your insurer may legally deny you coverage.
But what if a patient doesn’t have any other option but to undergo an experimental procedure? It can be incredibly frustrating to have paid insurance premiums for many years, only to find out that you will still owe a huge bill on your medical treatment. In fact, 62% of Americans oppose the decision by health insurers to deny coverage based on a cost-benefit analysis.
Millions of Americans find themselves stuck when it comes to coverage for innovative and rare medical procedures. While some of these techniques are the only available option and can actually benefit a patient, insurance companies tend to deny them and cause significant hardship as a result. In addition, some companies also deny coverage for procedures that aren’t approved by relevant government agencies. This means that when the FDA wrongfully classifies a procedure as experimental in nature, patients may suffer from the consequences of lack of coverage.
When determining the legality of experimental or investigational treatment denials, a lot comes down to the language of the insurance policy. A vague definition of what is “experimental” or “investigational” innature often creates loopholes for lawsuits against denied coverage. Many courts follow these guidelines when determining the legality of a denied claim.
The language of the policy
The medical literature available
The procedure to be followed by doctors
The number of patients who have received this treatment before
Governmental approval/disapproval for the procedure in question
What to Do When You Receive A Denial
Insurance denials are more common than most patients think. Even if you’ve been religiously paying your premiums for many years, it only takes one accident or health condition to end up with a huge medical bill.
Many insurance companies deny coverage for claims without carrying out a thorough investigation of the medical procedure in question. There are many procedures that are frequently carried out by medical professionals and are still classified as being experimental or investigational.
If you receive a denial for a claim based on the treatment being experimental, you should prepare to file an appeal. Insurance companies have a fiduciary duty to patients. They should ensure that they take adequate steps when providing coverage, and denials should only be issued when the claim is clearly out of the coverage policy guidelines.
There are several important steps you can take to fight for your coverage rights. These include:
Thoroughly examine the policy statement
Your medical policy statement is the guiding document that insurance companies use to determine coverage. In thisstatement, insurers include definitions for medical procedures that are deemed medically necessary, experimental, or not medically necessary.
When you make a claim, the insurer will simply pull out this statement, check your claim against their policies, and either accept or deny the claim. Interestingly, little time is spent researching the nature of your medical procedure and determining if you actually need it or not.
If you receive a denial, start off by examining your policy statement. Most statementsare long and have lots of medical language. This is mostly intentional so that patients find a hard time reading through the fine print. If you can find specific parts of the policy statement that are conflicting with your denial letter, you will have a much easier time filing an appeal.
Some insurers may even issue a denial for a procedure saying that it’s experimental in nature, only to find that the actual policy statement defines the exact same procedure as being medically necessary.
Look into the definitions of experimental and investigational treatment
Many insurers deny legitimate claims for coverage based on a treatment being “experimental,” but the real reason is because they don’t want to incur high costs of coverage. For example, a particularprocedure may not be FDA-approved but is commonly carried out in many reputable treatment centers.
However, an insurance company may simply deny your claim because the treatment is not FDA-approved. This grey area is enough grounds for filing an appeal based on medical necessity, fiduciary duty, and the safety/benefits of the technique in question.
Learn about the appeals process
The next important step you should take is to learn about the appeals process. Each insurance company has an in-house appealschannel, where you have several chances to have your claim reviewed.
Every patient is legally entitled to an appeal. Take time to learn how to prepare an appeal with your insurer, and work closely with your healthcare provider in preparing the appeal.
Overturning a Denial for Experimental Treatment
If the medical treatment you need has been determined experimentally, it’s not the end of the road. Paying out of pocket for the treatment you need could be crippling financially. Add that to the fact that you’ve been paying your premiums on time for many years.
Luckily, there are many cases where a denied claim for experimental treatment has been overturned. Even with a clear definition of what is “experimental” and “investigational,” there are still multiple channels you can use to contest a denial for treatment that you really need.
Here are some solid reasons you can use to overturn a denial.
There is enough experience with the procedure in question
Most insurers define an “experimental” procedure as beingnew and having insufficient medical data to back it up. But what if the procedure in question has been used frequently in the past and on many patients? A good example is lumbar artificial disc surgery for patients with back/spinal complications.
For manyyears, popular insurance companies such as Blue Cross, Cigna, and United Healthcare denied patient claims for this surgical option based on the procedure being investigational. You’d be surprised to find that medical professionals have been carrying out lumbar artificial disc surgery safely for a while now (and the procedure eventually became FDA approved in 2004).
Based on the experience that surrounded this surgical technique, a lawsuit filed against BlueShield in 2015 eventually compelled them to reverse this decision and include the surgery as being medically necessary.
The treatment is effective
If the treatment option in question is effective against your medical condition, you have sufficient grounds to file an appeal. The insurance company has afiduciary duty to provide reasonable coverage based on the premiums you pay.
Therefore, an insurer can’t simply deny coverage for an effective treatment procedure based on their blanket definition of “experimental” or “investigational.” In fact, if the procedure in question is backed by enough experience and has been shown to be effective, you have a good chance of having the denial reversed.
Many companies used to deny coverage for proton beam therapy (when treating prostate cancer). However, as the treatment continued to become more effective and performed in reputable medical centers, more insurers began accepting claims for the technique.
The treatment has been approved by other insurers and medical professionals
In some cases, peer pressure works inyour favor during a denial appeal. If an insurer classifies your treatment as being experimental, while many other insurance companies and medical entities approve the exact same procedure, you can make a claim for negligence or breach of fiduciary duty.
The treatment is the only available option
For certain rare medical conditions, the available treatment alternatives may be limited. Your only available option may be an experimental or investigational procedure.
Rather than continuing to deal with the challenges of your ailment, undergoing a rare/innovative treatment may be your only hope for recovery. Such a case may form solid grounds for an appeal if your claim is denied.
If you’ve been denied coverage for a treatment option that you really need, the feeling can be overwhelming. A lot goes into categorizing a particular treatment as experimental or investigational. While some treatment methods are truly rare and innovative, others may be generally acceptable but not recognized by your insurance company. However, every patient deserves reasonable coverage after religiously paying premiums.
At Stop Insurance Denial Law Firms, we can help you take on large insurance companies and receive the coverage you need. The unfortunate truth is that many insurers don’t spend enough time investigating a medical procedure, its risk-benefit comparison, and the available medical data to support it. Therefore, many claims are wrongfully categorized as experimental andultimately denied.
By seeking legal help, we can carefully examine why the claim was denied, analyze your insurer’s policy statement, and help you file an appeal that’s supported by relevant case law. We can also represent you in court if your claim ends up before a judge.
Have you been denied coverage based on an experimental or investigational treatment? Contact us todayat 310-878-1771.