Experimental or Investigational Treatment

We Fight for the Coverage You Deserve and Treatment You Need

We Ensure That Your Health Concerns Are Not Dismissed and Fight for the Coverage You Deserve and Treatment You Need

Health insurance, while comprehensive, does not cover every drug, medical device, or treatment recommended by physicians. In addition to denying claims on the ground that the service or product is not “medically necessary,” another common reason cited for denial of coverage is that the service, drug, or device is “experimental” or “Investigational” treatment meaning that research remains ongoing. Experimental or Investigational treatments are not covered by insurance, even when data may show that the treatment or service may be the best or only solution to a medical problem. Moreover, insurers may try to claim that a treatment is experimental or investigational even when it has been accepted by mainstream medical society or approved by the U.S. Food and Drug Administration. Patients whose claims are wrongfully denied may be able to challenge a denial, though.  

If you have a medical issue and your health insurance provider denies coverage for treatment because the procedure is deemed experimental or investigational, the attorneys at DeBofsky Law are experienced with all facets of experimental or investigational treatment claims and may be able to assist you in challenging a denial asserting that the treatment or product at issue is experimental or investigational. We will appeal wrongful denials, where appropriate; and if necessary, take the issue before a judge.  

Why Did My Health Insurance Company Deny My Claim?

Medical advances occur daily.  New drugs are developed that treat previously incurable conditions, near-miraculous medical devices that can be implanted into the body can control conditions that were thought uncontrollable, and procedures such as the use of proton-beam therapy to treat cancer, can target effective treatment more than ever before.  But just because a doctor has a new medication, device, or treatment available does not mean that insurance will reimburse the cost of receiving the treatment.  The drug may not be more effective than other previously-developed drugs, and the device or treatment may not have a proven improved outcome for patients over other devices or treatment.  Thus, all health insurance policies contain exclusions for any treatment deemed experimental or investigational with the goal of reimbursing treatment only if it has been proven to be safe and established as the most medically and cost-effective treatment.  The exclusion covers drugs that have not yet been approved by the U.S. Food and Drug Administration or which have not yet been found safe and effective for use with respect to the condition at issue.  In addition, the exclusion covers non-FDA-approved medical devices or devices or therapies whose efficacy and proven ability to work better than other devices or treatments has yet to be demonstrated.

How Would I Know When a Drug, Device, or Treatment Is Considered Experimental or Investigational?

In most instances, patients first learn that a drug or treatment their doctor has recommended is considered experimental or investigational when their insurance company is contacted for pre-approval of the service or prescription. However, any time a patient is asked to sign an informed consent document that explicitly states the medication or treatment is experimental or investigational, it is highly unlikely that an insurance company will provide reimbursement. In many such instances, though, the treatment is provided to the patient without charge by a pharmaceutical company or medical device manufacturer. If not, it will be extremely difficult to challenge an insurance company’s determination that a drug, device, or service is experimental or investigational and that reimbursement is owed.

In addition, most insurance companies bolster their determination that a medication or treatment experimental or investigational by publishing medical “policies” on their websites that identify which drugs, devices, or treatments are viewed as experimental or investigational; and the insurance companies often include citations to the medical literature in support of their policies.  Those policies are regularly updated in an effort to stay abreast of recent developments such as approvals by the Food and Drug Administration or recent peer-reviewed studies.

Know Your Rights

Whether you’re your treatment is subject to the Experimental or Investigational Exclusion depends on your specific health plan.

Our team has the knowledge and experience to evaluate your plan and guide you to get the benefits to which you are entitled and the care you need.


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Contact DeBofsky Law for an attorney consultation. We will work with you to figure out your problem, and how we can help.

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How Do I Challenge a Health Insurance Denial Based on the Exclusion for Experimental/Investigational Treatment?

In many instances, it may be nearly impossible to challenge a denial based on the exclusion for experimental and investigational treatment. Although the drug, device, or service may have been recommended by the treating doctor as a lifesaving measure, that is not the gauge by which insurance companies determine coverage. Denials based on experimental/investigational treatment are also disheartening because today’s experimental treatment often becomes tomorrow’s gold standard cure or treatment. However, until that day arrives, the denial may be unchallengeable. In such instances, it is critical for the patient to consult with their doctor to find out if there is a means of having the pharmaceutical company or medical device manufacturer to pay for the drug or device. Or there may be funding from a research grant.

But the insurance company may also be wrong. Especially if the patient is being treated at a major medical center or university-affiliated hospital, the treating doctors have access to the latest research, sometimes before it is even published. Further, even though insurers update their policies regularly, they may become quickly out of date due to advances in medical science.  An authoritative widely available on-line publication from WoltersKluwer known as UpToDate® is considered the most authoritative and current source of medical information, and may contain support for a drug, device, or treatment that post-dates the last update of the insurance company’s applicable medical policy.  The patient’s doctor should have access to that resource.

When Should I Seek Legal Help to Challenge a Denial Based on Experimental/Investigational Treatment?

While the treating doctor may be able to convince the health insurer that the exclusion was improperly invoked, patients who receive claim denials based on the experimental/investigational exclusion should not count on that happening. Any patient who is faced with a denial of what might be their only lifesaving treatment option, or which would have less invasive consequences or side-effects than alternative treatment should immediately seek legal help as soon as the exclusion is raised.

An attorney experienced in handling cases involving health insurance denials can quickly evaluate the situation; and, working with the treating physician, determine the best way to challenge a denial.  Sometimes, it may involve a claim appeal; in other instances, it may be to pursue independent external review procedures that are a component part of the Affordable Care Act.  Ultimately, though, litigation may be the only recourse to challenge an unjustified denial based on the experimental/investigational treatment exclusion. Such litigation may involve the need to seek an immediate court injunction requiring the insurance company to reimburse the cost of treatment.  

The attorney must also be experienced in handling claims arising under the Employee Retirement Income Security Act (ERISA), the federal law that governs most employer-sponsored health insurance claims.  ERISA claims have special rules and procedures that need to be followed in order to achieve success in court if pre-litigation appeals are unsuccessful.  Not every case can be won, but having experience and expertise on the side of the patient certainly helps even the odds.

Health and ERISA Lawyers With a Record of Getting Clients Coverage So That You Can Focus On Your Health

If you or a loved one is in need of treatment that your insurance company has refused to cover on the ground that it deems the service or product experimental or investigational , the legal team at DeBofsky Law are here to help.  Contact our firm today to find out how we can work with you to get your insurance company to pay for the treatment you need.

“Went above and beyond to help me with my case.”


Tricia D| Client

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