Off-Label Prescription Drug Denied by Insurance in California? What to Do Next

Legally reviewed By Scott Glovsky in Insurance Bad Faith

If your doctor has prescribed a medication for you or a loved one, such as IVIG, he or she is not guessing.

The decision is based on training, experience, and perhaps the reality that “standard” treatments have failed. Yet many insurance companies will deny coverage for an off-label prescription – even when the treatment is widely accepted among medical professionals.

Such a denial can delay your care, allow your symptoms to worsen, and leave you facing overwhelming financial costs. If your insurer has refused to cover IVIG or another off-label medication, you do have options. The denial may not be the final word, and challenging the decision can often result in a reversal.

If you or a loved one is facing a serious illness, having your insurance company deny a treatment or drug that your doctor believes will make a difference in your future can be devastating. You need a strong advocate in your corner who will fight for justice on your behalf.

Attorney Scott Glovsky and his dedicated team will work tirelessly on your behalf, never hesitating to take on big insurance companies. When you feel like you are at the end of the road with nowhere to turn, Scott Glovsky will commit to you and your case, working hard for the best possible outcome. Below are some frequently asked questions regarding off-label medication prescriptions in California, as well as IVIG specifically.

If your insurance company denied coverage for IVIG, or any other off-label medication, you have options. Don’t navigate this alone – call us at 626-243-5598 or contact us online for free to get clarity today.

What Does “Off-Label” Prescribing Mean?

“Off-label” prescribing means a pharmaceutical medication is being used for a condition that is not specifically listed on the FDA-approved labeling. Off-label prescribing does not mean the treatment is unsafe or ineffective. Many off-label uses are widely accepted by medical professionals, even allowing for innovation when a drug shows promise for other conditions before the formal approval process is completed.

In other cases, off-label prescribing can be necessary, even life-saving, when no approved treatment exists for a specific condition or rare disease. In the United States, off-label prescribing is legal, common, and based on scientific evidence.

In short, off-label prescribing involves using a drug for a different disease, a different dosage, or a different method of administration than the official FDA approval covered. Off-label prescriptions are frequently used in pediatrics, oncology, and psychiatry. As an example, A cancer drug that has garnered FDA approval for breast cancer might also be used for ovarian cancer, or a medication initially approved for adults could show promise for use in children.

Drugs approved by the FDA for a specific indication may not have been as rigorously vetted for off-label use, but trained medical professionals can rely on other scientific evidence to prescribe them off-label. Since the FDA does not regulate the practice of medicine, physicians can legally prescribe approved drugs for non-approved uses if they believe it is in their patients’ best interests. Pharmaceutical companies, however, are not allowed to market or promote their drugs for off-label use.

What is IVIG and Why Is It Prescribed Off-Label?

Intravenous Immunoglobulin (IVIG) is a medication derived from human plasma. IVIG contains concentrated antibodies from thousands of donors and is used to boost the immune system in a state of deficiency. IVIG is infused directly into the veins, often taking several hours and requiring sessions every 3-4 weeks. For autoimmune conditions, IVIG can regulate an overactive immune system. IVIG is currently prescribed off-label for more than 80 conditions due to its ability to improve immune functions and modulate severe inflammation when other FDA-approved treatments have failed.

IVIG neutralizes autoantibodies, blocks receptors for damaging cytokines, and inhibits inflammation. IVIG is FDA-approved for immune thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), Kawasaki disease, multifocal motor neuropathy, B-cell chronic lymphocytic leukemia, and for the prevention of infections in bone marrow transplant recipients and pediatric HIV patients. In addition to traditional, FDA-approved uses, IVIG is heavily used off-label for more than 150 diverse conditions, including:

• Multiple sclerosis
• Myasthenia gravis
• Guillain-Barré syndrome
• Stiff-person syndrome
• Rasmussen’s encephalitis
• Evan’s syndrome
• Scleromyxedema
• Pediatric autoimmune neuropsychiatric disorders (PANDAS)
• Secondary hypogammaglobulinemia
• Prevention of organ transplant rejection
• Graft vs. host disease
• Recurrent spontaneous abortions

IVIG is in high demand as an immunomodulator, given the lack of approved treatments for rare conditions, and is often used when standard treatments (such as plasma exchange or corticosteroids) have failed or are contraindicated.

What Are Some Other Drugs That Are Commonly Prescribed Off-Label?

According to the New England Journal of Medicine, off-label drug use accounts for between 21 percent and 38 percent of all U.S. prescriptions. Some of the most common off-label prescriptions include:

• Gabapentin, approved for seizures, is widely used for insomnia, anxiety, neuropathy, and chronic pain.
• Quetiapine (Seroquel) is an antipsychotic that is frequently used to treat chronic insomnia.
• Spironolactone is a diuretic, which is used off-label for female hair loss and acne.
• Naltrexone is used at lower dosages for autoimmune conditions and chronic pain.
• Metformin is a drug approved for Type 2 diabetes, which is often used to manage Polycystic Ovary Syndrome (PCOS).

• Approved as an antidepressant, trazodone is often used to treat chronic insomnia.

• The blood pressure medication propranolol is often prescribed for anxiety, migraines, and PTSD.

• Topiramate is an anticonvulsant that is often prescribed for alcohol dependence and binge eating disorders.

• Amitriptyline is an antidepressant that is also prescribed for insomnia and migraines.
• Perhaps one of the most well-known off-label drug uses is semaglutide (Ozempic/Wegovy), which is approved for diabetes but often used for weight management in patients without diabetes.

The primary reasons for off-label use include a lack of alternatives and emerging evidence that a drug shows real promise in studies prior to FDA approval for the new indication.

Why Do Insurance Companies Deny Off-Label Prescriptions?

Unfortunately, insurance denials for IVIG and other off-label medications are all too common. Denials of off-label medications are generally part of a broader system designed to control costs. Despite the fact that off-label prescribing is often used when standard treatments have failed, insurers may deny coverage by claiming the drug is “experimental,” “investigational,” or “not medically necessary” – even when doctors and clinical research clearly support the off-label use.

Insurance companies often rely on rigid internal guidelines that fail to reflect current medical practice. You or a family member may be denied an off-label drug because your diagnosis fails to specifically match a narrow list of approved treatments. The insurer may claim there is insufficient evidence to warrant the off-label use or that you have not “failed” several cheaper treatments (step therapy).

The results of an off-label drug denial can be devastating, forcing you to wait months or years for the drug to be FDA-approved for your condition, even as your physician strongly recommends the off-label use. If appeals are unsuccessful, legal action may be necessary when an insurer fails to follow its own policies or acts unreasonably. When you understand your rights, have legal counsel, and act quickly, it can mean the difference between access to a potentially life-changing medication and continued suffering.

Why Would IVIG Off-Label Coverage Be Denied?

As with any drug prescribed for off-label use, your insurer may claim that the peer-reviewed research supporting the off-label use is insufficient to prove it is effective, you have failed to complete step therapy, your doctor has failed to provide evidence of medical necessity, your insurer specifically excludes coverage of the drug, or the treatment is not administered in the insurer’s preferred setting. In reality, the denial of IVIG off-label use is too often related to cost, more than any other reason. IVIG therapy is a high-cost treatment, ranging from $10,000 to $40,000 per month, depending on dosage, condition, and location. Home infusions tend to be considerably less expensive ($1,500 +) than hospital infusions ($13,000+).

How Do Insurance Companies Evaluate IVIG Off-Label Claims or Other Off-Label Coverage?

Insurance companies generally evaluate IVIG or other off-label claims through a review of:

• Diagnosis codes
• Treatment history
• Supporting clinical documentation
• Use of medical necessity definitions
• Reliance on internal policy guidelines
• Whether the diagnosis matches the covered indications
• Submitted compelling evidence

Most insurers are highly skilled in using tactics to deny IVIG or other off-label medications. These tactics oftentimes discourage or wear down the patient, causing them to give up. Insurers may require a series of step therapies, delay authorization decisions, demand excessive documentation, have narrow diagnostic coding requirements or arbitrary lab value thresholds, or may even reclassify a treatment as investigational.

What You Need to Know About Off-Label Prescription Denials

The main thing you should know about an off-label prescription denial is that you have options. Many people fail to appeal an adverse decision because they think it is futile. This is hardly the case. According to the American Medical Association, although fewer than 1 percent of patients appeal denied insurance claims, 50 percent to over 80 percent of appeals are successful. Many denials can be overturned on appeal with proper documentation.

What Are Some of the Legal and Policy Considerations for Off-Label Coverage?

Off-label drug coverage laws can vary widely from one state to another. Some states require coverage of off-label drugs only under certain conditions, such as an abundance of peer-reviewed literature supporting the off-label use. In addition to state laws, the insurer’s obligations to approve off-label drug coverage can vary based on the insurer’s policy language and bad-faith standards.

What Protections Does California Offer Regarding Off-Label Drug Use?

California physicians can legally prescribe FDA-approved medications for uses not listed on the drug’s official label, and this is generally considered a part of a physician’s professional medical judgment. So long as the physician is prescribing in the patient’s best interests, conducts an appropriate evaluation, and is properly licensed, off-label prescription drug use is allowed. Under California Insurance Code (including Section 10123.195), health insurers are not allowed to deny coverage for off-label drug use solely based on off-label status. Coverage for an off-label drug must be provided to the patient so long as specific conditions are met, including:

• The drug is considered medically necessary.
• The use of the off-label drug is supported by generally accepted standards of care
• Credible scientific evidence exists that supports the use of the off-label drug.

In short, “off-label” does not equal experimental, under California law. California Section 1367.21 establishes three independent pathways for coverage of an FDA-approved off-label pharmaceutical to treat a chronic and seriously debilitating condition: recognition in the American Hospital Formulary Service’s Drug Information, or recognition in specified drug compendia, or support in two peer-reviewed journal articles.

Accepted drug compendia include Elsevier’s Gold Standard Clinical Pharmacology, the National Comprehensive Cancer Network Drug and Biologics Compendium, and Thomson’s Micromedex DrugDex. Further, a health care service plan contract that covers prescription drug benefits shall not be “issued, amended, delivered, or renewed” in California if the plan limits or excludes coverage for a drug on the basis that the drug is prescribed for a use different from the FDA-approved use.

California insurers must cover medically necessary off-label prescription drugs if the policy includes drug benefits. If a drug was previously approved, insurers cannot suddenly deny continued coverage when still medically appropriate, and denials based on “experimental” or “investigational” use are subject to independent medical review. California also regulates how insurers handle approvals.

Insurers must respond to prior authorization requests within 72 hours for standard cases and within 24 hours for urgent cases. Failure to respond within these timelines can result in automatic approval. So, in practical terms, your doctor can legally prescribe IVIG or other off-label treatments, and your insurer may not deny coverage simply because it is off-label.

What Can You Do Following an IVIG or Other Off-Label Prescription Denial?

If your California insurer has denied IVIG or another off-label prescription drug, you must request the full denial rationale to identify the precise reason for the denial. You can work with your physician to submit peer-reviewed studies, treatment history, and a letter of medical necessity. You will first file an internal appeal, which addresses the insurer’s reasoning for the denial. If the insurer upholds the original denial, you can request an external review from a neutral third party. The decision of this third party is binding on the insurer. If the denial contradicts policy terms or medical evidence, you might consider legal action. If there is bad-faith conduct by the insurer, you should also consider legal action.

Does Legal Representation Really Make a Difference Following an Off-Label Medication Denial?

Strong legal representation following a denial of an off-label medication can be crucial. Your attorney can identify any policy violations, challenge systemic denial practices, leverage expert testimony, and ensure “medical necessity” is properly framed. Insurance denial attorneys hold insurance companies accountable for profit-driven denials. Legal representation is especially warranted if your appeal has been repeatedly denied, your insurer is ignoring medical evidence, or the denial is inconsistent with the terms of your policy. While insurers can deny coverage based on policy terms, those terms must be followed reasonably and consistently.

How The Law Offices of Scott Glovsky Can Help

If your insurer has denied IVIG or another off-label medication, you do not have to face the situation alone. Attorney Scott Glovsky can evaluate your claim, guide you through the appeals, and take legal action when your insurer fails to meet its obligations. If you have received an IVIG or other off-label medication claim denial, do not assume that the decision is final or even valid. In California, insurers may not simply dismiss a treatment because it falls outside of FDA labeling when your insurer can show it is medically necessary and supported by credible evidence.

Scott and his legal team will help you fight delays and technical denials, while simultaneously determining whether your insurer has violated state law or acted in bad faith. The right advocacy can mean the difference between continued denial and access to the treatments your doctor believes you need for your health and your future. Contact The Law Offices of Scott Glovsky online or call us at 626-243-5598 today.