Intravenous Immunoglobulin (IVIG) Health Insurance Denial Attorney
Have you or a loved one received an IVIG Health Insurance Denial? We Can Help
Intravenous immunoglobulin (IVIG) has been treating patients with antibody deficiencies for decades. With FDA approval to treat a variety of autoimmune and idiopathic diseases, IVIG therapy treats a wide range of conditions. It most commonly treats primary humoral immunodeficiency, a category of patients with immunodeficiencies. IVIG can treat Kawasaki disease, lupus, and myositis. It can also treat Guillain-Barre syndrome, vasculitis, immune thrombocytopenia, and beyond. IVIG treatment can be difficult to obtain due to its expensive price tag. This article addresses IVIG health insurance coverage claims. It explores how insurance companies determine if IVIG treatment is medically necessary. It also offers steps for patients who receive a denial for an IVIG insurance claim. If you receive an IVIG health insurance denial, contact the Law Offices of Scott Glovsky. We have successfully litigated health insurer denials of IVIG.
What is Intravenous Immunoglobulin (IVIG)?
Intravenous immunoglobulin (IVIG) is a medication that treats patients with immunodeficiencies. The drug contains antibodies, or immunoglobulins, from human donor plasma. Although IVIG contains donor plasma, the solution is sterilized and infection resulting from the plasma is extremely rare.
How is IVIG administered?
Doctor’s offices and hospitals administer IVIG to patients intravenously through arm veins over the course of a few hours. Once infused into the blood, IVIG antibodies supplement the immune system of the patient and help to fight infections.
Is there an age range of who is helped by IVIG and how often is it given?
Both adults and children with antibody deficiencies can undergo IVIG therapy. The standard dosage for an immunodeficient adult is 400-600 mg/kg of IVIG taken once every 3 to 4 weeks. IVIG can treat immunodeficiency on its own but can also supplement immunosuppressants or other medication plans. More information about IVIG treatment can be found here.
What health concerns does IVIG treat?
Physicians prescribe IVIG treatment for autoimmune and idiopathic diseases. The drug most often treats conditions like Kawasaki disease, lupus, myositis, and immune thrombocytopenia. It also treats Guillain-Barre syndrome, vasculitis, and other autoimmune diseases.
IVIG products are FDA approved to treat a variety of conditions, including the following:
- Primary Humoral Immunodeficiency
- Multifocal Motor Neuropathy
- B-cell Chronic Lymphocytic Leukemia
- Immune Thrombocytopenic Purpura
- Kawasaki syndrome
- Chronic Inflammatory Demyelinating Polyneuropathy
The full FDA description of IVIG products, manufacturers, and indications can be found here.
Do insurance companies cover IVIG treatment?
Health insurance coverage for IVIG therapy varies across providers and disease types. Medicaid coverage varies across different states. Medicare, the federal health insurance program for people 65 and older, can provide IVIG coverage under certain conditions. Immunodeficient patients prescribed IVIG most commonly get Medicare coverage through Medicare Part B. In specific cases, a Medicare Advantage Plan can cover this treatment under Part D. Providers must submit claims under Part B or Part D separately.
Anthem, Aetna, UnitedHealthcare, Humana, HCSC, Blue Shield, and Kaiser Permanente also hold varied coverage policies. Different autoimmune diseases and patient histories result in different approval processes. Commercial private health insurance companies typically approve IVIG claims when they deem them medically necessary.
Is IVIG treatment medically necessary or medically beneficial?
To cover IVIG treatment, most insurance companies require prior authorization. Prior authorization refers to the decision from an insurer that deems a drug to be medically necessary. Medical necessity assumes that a drug is necessary to treat the signs or symptoms of a disease. Prior authorization can be tricky to obtain due to the internal requirements of insurance companies.
A health insurer might deny treatment for IVIG if they deem it not medically necessary. Although IVIG may be medically beneficial for a patient, this does not mean it is medically necessary. Several treatments and therapies can treat autoimmune and idiopathic diseases. An insurer may prefer these alternatives to IVIG treatment because they are less expensive. IVIG is an expensive therapy comparatively. An insurer may deem IVIG not medically necessary because of these alternatives.
Health insurance companies might practice step therapy when alternative drugs exist. Step therapy is a type of prior authorization. Step therapy refers to when insurance companies require a patient to try an alternative drug over a doctor preferred drug. Patients may try generic or cheaper drugs until they prove ineffective. For this reason, sometimes step therapy is called a “fail first” policy. Most insurance companies require around 60 days of trial. If the alternative is ineffective, then the insurance company may re-evaluate the necessity of a preferred drug. Unfortunately, autoimmune and idiopathic conditions often require expensive specialty drugs. Because IVIG is expensive, insurers may require step therapy to obtain claim approval. Step therapy can be harmful to patient wellbeing and health. The process of testing alternative drugs can prolong disease and symptoms. Without prior authorization, patients often cannot obtain preferred name-brand drugs.
In about five states, your doctor may complete a form asking your insurance company to bypass step therapy. Your insurer may deny this request. However, in California, if your insurer doesn’t respond to the request within 72 hours (24 hours if your request is considered urgent), the request is considered approved. Step therapy is permitted in all states. That said, there are about 29 states with laws that mandate a procedure where practitioners can shield patients from step therapy with a list of exemptions that insurance companies must adhere to.
How do insurance companies evaluate IVIG coverage requests?
The internal medical or pharmacy policies of insurers set the guidelines for evaluating coverage requests. When the FDA approves IVIG treatment for an autoimmune condition, insurers then research the therapy to develop clinical policies. Internal clinical policies guide decisions on medical necessity. A group of external doctors vote on these internal policies to determine their merit. Promises of financial gains or the potential to work for said insurers, however, can sway these doctors. As such, the external doctors often approve overly restrictive internal policies.
To evaluate a claim, insurers must decide whether a drug is medically necessary or experimental / investigational. Restrictive policies can create a gap between what a physician versus an insurer deem medically necessary. Peer-reviewed medical literature guides the treatment decisions of physicians. This literature outlines safe and effective treatment options for different patient circumstances. Peer-reviewed literature is based on scientific evidence and research.
What is medically necessary vs. experimental or investigational?
Upon receiving an IVIG claim, insurers will determine if IVIG treatment is medically necessary. If they deem it not medically necessary, they may consider it experimental / investigational. Insurance companies may consider IVIG therapy as experimental / investigational for a few reasons. Internal policy definitions of experimental / investigational guide these decisions. First, inconclusive evidence about the effectiveness of a drug may make it experimental / investigational. Second, lack of FDA approval can also make a treatment experimental / investigational. Third, safe and effective alternative drugs may make a lesser known drug experimental / investigational. Last, if a drug is not applicable or does not improve health outcomes, it may be experimental / investigational.
Different insurance companies make different designations on medically necessary versus experimental / investigational drugs. The internal guidelines for categorizing drugs can vary and are open for interpretation. Patients also experience different health outcomes with the same drugs. These factors contribute to the rifts in the claim approval process. Insurers have been known to deny coverage even for common drugs like Aspirin. Their decisions all depend on contract language. The language of these guidelines is subjective, making the process complex.
What is the duty of insurance companies when members submit claims?
Insurance companies must review submitted claims and make a decision to approve or deny them. In this process, the insurance company must thoroughly investigate the request. They must investigate all possible reasons why said drug may be medically necessary. Insurers also have an obligation to respond to claims in a prompt manner. Finally, qualified medical professionals must review these claim requests.
Has our firm litigated IVIG health insurance denial cases before?
The Law Offices of Scott Glovsky has represented consumers in issues of health insurance bad faith for decades. Notably, Scott Glovsky represented Gillen Washington in the Washington v. Aetna case. Aetna denied coverage for Washington’s intravenous immunoglobulin (IVIG) treatment. Washington sued Aetna for breach of contract and bad faith. He alleged that this denial resulted in life-threatening injury. Washington required IVIG therapy for his common variable immune deficiency (CVID). The case ended in a settlement from Aetna.
Why did this case get national attention including several states?
Originally, Aetna had rejected Washington’s allegations of wrongdoing. They argued that Washington had not provided proper documentation of his blood work in the claim. During the deposition of Dr. Jay Ken Iinuma, the former Aetna medical director revealed bad practice. Iinuma noted that he did not look at medical records during his review of patient claim requests. Instead, he relied solely on his nurse’s summary and recommendations. Scott Glovsky further questioned Iinuma on these admissions. Iinuma revealed that he did not look at medical records throughout his tenure. Iinuma noted that he was trained to review claims in this way.
Inuma’s deposition prompted an investigation from the California insurance commissioner’s office. Aetna also heard public criticism from people within all sectors of the medical community. In response, Aetna released a statement that Iinuma misunderstood the claims. Its statement included new remarks from Iinuma noting that he misunderstood the term “medical record.” Aetna settled the lawsuit with Washington. A settlement is not an admission of wrongdoing. However, it is also not common that Aetna would agree to a settlement if there wasn’t something amiss. The case received national media attention from organizations across the country. The deposition led to Aetna inquiries from more states, including Colorado, Washington, and Connecticut. Even the United States senate asked Aetna to respond to its inquiry on whether it complied with federal law. More details about the settlement can be read
What can you do if you receive an IVIG health insurance denial?
You have a right to appeal an IVIG health insurance denial. To begin the appeal process, it is important to know whether you have an ERISA or non-ERISA plan. ERISA stands for the Employment Retirement Income Security Act of 1974. You can contact your plan administrator for information on your plan type.
Private employers typically provide their employees with ERISA plans. But there may be exemptions in the following cases:
- government employee plans
- religious organization plans
- business plans that only cover business owners
- individual and family plans through Covered California
- Individual and family plans purchased through private insurance companies like Anthem Blue Cross or Blue Shield of California
You should file an appeal if you have an ERISA plan. However, it is best to speak with an attorney before filing this appeal. Learn more about the appeals process for ERISA policies here. If you have a non-ERISA plan, you have many options. It is important to first understand why your claim was denied. Non-ERISA plan members can learn more here.