Remicade Health Insurance Denial

Remicade Health Insurance Denial Scott Glovsky

Have you or a loved one received a Remicade Health Insurance Denial? We Can Help.

First approved by The Food and Drug Administration (FDA) in 1998 to treat Crohn’s disease, Remicade® (infliximab) is a medication that affects the immune system. It works by blocking the production of TNF-alpha proteins. TNF-alpha blockers can reduce the inflammation and symptoms caused by immune-system diseases such as Crohn’s Disease and ulcerative colitis. Other immune diseases Remicade helps include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Remicade was developed by Janssen Biotech, a pharmaceutical company of Johnson & Johnson. Remicade is proven to achieve a response at week 2 of treatment. In clinical trials, nearly 4 out of 10 patients achieved remission by week 30. This article addresses Remicade health insurance coverage claims. It also discusses how insurances companies determine medical necessity. Medical necessity typically is required from Blue Shield, Anthem Blue Cross, and other health insurers. Finally, it covers next steps after receiving a health insurance denial. If you receive a Remicade health insurance denial, contact the Law Offices of Scott Glovsky.

What Illnesses does Remicade Treat?

Remicade is used to treat patients with certain autoimmune diseases in which there is an overproduction of the TNF-alpha protein. Remicade is FDA approved to treat the following conditions:

• Moderately to severely active adult & pediatric Crohn’s disease
• Moderately to severely active adult & pediatric ulcerative colitis
• Active adult psoriatic arthritis
• Moderately to severely active adult rheumatoid arthritis
• Active adult ankylosing spondylitis
• Chronic severe adult plaque psoriasis

See the FDA prescribing information here.

What is Remicade?

Remicade is a prescription medication for people living with certain autoimmune diseases. It is typically prescribed for patients who have not responded well to other medicines. Remicade is a part of a class of biologic medications known as tumor necrosis factor-alpha (TNF-alpha) blockers. TNF-alpha is an important protein produced by the immune system, essential for the body’s defense against infections and cancers. Unfortunately, in patients with certain autoimmune diseases, an excess of TNF-alpha is produced, which can lead to the destruction of healthy cells. Remicade works as a TNF-alpha blocker, to prevent the inflammation and damage done by the overproduction of the TNF-alpha protein.

How is Remicade administered?

Remicade is administered through intravenous infusion into the patient’s arm. Infusions occur in a healthcare setting, performed by a trained healthcare professional. The overall infusion process takes no less than two hours.

How often do you need to take Remicade?

There are 3 starter doses, taking place at weeks 0, 2, and 6. After these starter doses, one maintenance dose is administered every 8 weeks.

Are there risks with Remicade?

Due to its nature as a TNF-alpha blocker, Remicade is an immunosuppressant drug. This can make patients more susceptible to infection, so it’s important that patients keep their doctors informed of all health issues while taking Remicade. See the medication guide for Remicade here.

How much does Remicade cost?

For one dose, Remicade can cost between $1,300 and $2,500. Understandably, most patients depend upon their health insurance coverage to receive this treatment.

Is Remicade given as a stand-alone drug?

Sometimes Remicade is prescribed alone, and other times it is given together with other drugs. Remicade is an expensive medication. As such, doctors often begin treatment for a given health condition with a less expensive drug. If this option doesn’t work, physicians try different drugs. And sometimes, only combinations of pharmaceuticals work. For example, for a condition like Rheumatoid Arthritis, Remicade is often combined with methotrexate (Rheumatrex, Trexall, Otrexup, Rasuvo). Unfortunately, sometimes it takes a lot of trial and error to find the specific drug or drugs that work for individual patients.

Are there alternative drugs to Remicade?

As mentioned above, often practitioners start patients on treatments or alternate drugs that are less expensive. The alternative selected depends on the specific health condition treated. Here is a list of some alternatives:

• Crohn’s Disease: Because biologics are expensive, doctors may start with anti-inflammatory medications such as corticosterioids or oral 5-aminosalicylates. They also may prescribe immune system suppressors like azathioprine and mercaptopurine as well as methotrexate. Expensive biologics approved by the FDA including Stelara (ustekinumab), Humira (adalimumab) and Entyvio (vedolizumab). And there are others including antibiotics, anti-diarrheals, pain releivers and more.
• Ulcerative Colitis: Again, biologics are not inexpensive. So physicians often begin with anti-inflammatory medications and immune system suppressors. Biologics recommended may include Remicade, Humira, Simponi, Entyvio, and Stelara.
• Psoriatic Arthritis: Over the counter (OTC) NSAIDs can reduce inflammation and help with pain. These include ibuprofen and naproxen sodium (Aleve) among others. DMARDs slow down the progression of the disease and also help avoid permanent damage in some tissues and joints. Biologics here include Humira, Cimzia, Enbrel, Simponi, Remicade, Stelara, and others.
• Ankylosing Spondylitis: Physicians often treat this disease with NSAIDs like naproxen and ibuprofen. While these OTCs help with pain, stiffness and inflammation, they can also lead to gastrointestinal bleeding. TNF blocker biologics used include Humira, Remicade, Enbrel, Simponi and Cimzia. IL-17 inhibitors like Cosentyx and Taltz may be prescribed.
• Plaque Psoriasis: Medications try to stop skin cells from growing fast and to remove scales. These include light therapy, topical therapy like creams, and injected or oral drugs. Topical therapy includes retinoids, calcineurin inhibitors, vitamin D analogues and corticosteroids, among others. Light therapy includes UVB, sunlight, and others. Injections or oral medications include steroids, retinoids, methotrexate, Remicade, Enbrel, Humira, Stelara and others.
• Rheumatoid Arthritis: This disorder can be difficult to diagnose. Treatments include NSAIDs, DMARDs, steroids and biologics. Biologics include Humira, Enbrel, Remicade, Kevzara, Orencia, and others.

Will Insurance Companies Cover Remicade?

Government health insurers like Medicare (called, “Medi-Cal” in California) and Medicaid will likely cover Remicade because they typically cover medications approved by the FDA. However, coverage varies by state. Note that Remicade is often covered under Medicare Part B but not under Part D. Oftentimes Medicare and Medicaid also rely on national guidelines from independent organizations like the National Comprehensive Cancer Network for cancer treatments and medications.

But all insurance companies are different. Cigna, Kaiser, Anthem Blue Cross, Blue Shield of California, UnitedHealthcare and others have different internal policies. Their policies are based on how each one evaluates new drugs and a potential Remicade health insurance denial.

How Do Various Health Insurance Companies Evaluate Medication Claim Requests?

Companies establish their own policies called “medical” or “pharmacy” policies. These policies include internal clinical guidelines on the factors and conditions in which medications and treatments are “medically necessary.” (Approved medications are included in their medication “formularies.”) Health insurance companies track new prescriptions approved by the FDA. Internal pharmacists research medical literature about the drugs. Then, they provide a recommendation on whether medications like Remicade are medically necessary or experimental / investigational.

Oftentimes, health insurers take these recommended policies to a group of external doctors who influence whether the policies are appropriate. However, there may be some other motivations at play. The external doctors who help determine policies are oftentimes paid by the insurance companies. As such, there might be an incentive to affirm an overly limited policy. Also, the external doctors may want to work for the insurer. These doctors then have an additional incentive to agree with proposed policies. Of course insurers have incentives not to include expensive medications because they impact the corporate bottom line.

Unfortunately, all too often insurance company policies are overly restrictive. In fact, they may not include what independent physician specialist organizations determine is safe and effective for treating medical conditions. There is the term, “generally accepted standards of medical practice.” This refers to  standards based on credible scientific evidence that is published in peer-reviewed medical literature. They are generally recognized by the relevant medical community and are accepted by other healthcare workers in the community. Unfortunately, an insurance company policy may differ from what a patient’s doctor believes is medically necessary.

Is Remicade Medically Necessary or Medically Beneficial?

These two terms are not the same. While a procedure or pharmaceutical might treat a condition, it may not be medically necessary in the insurance contract. The perfect example is when a less invasive and less costly procedure is available for the symptom. In this case, according to some insurers, a more expensive and advanced procedure for this same symptom may not be medically necessary.

Oftentimes, insurance companies use “step therapy” to deny more expensive drugs and approve less costly ones first. In the state of California, patients must stay on the approved drug for 60 days prior to switching to a different medication. You can get an exemption, but California exemption laws have many loopholes and poor enforcement systems. As mentioned previously, step therapy can cause harm to patients when the medications don’t prove effective. Insurance companies use step therapy often with complicated, incapacitating medical diseases like cancers and autoimmune disorders. All too often, the rationale is that these conditions depend on specialty drugs that are quite costly.

When is Remicade Medically Necessary and when is it Experimental / Investigational?

When an insurer deems a pharmaceutical or treatment not medically necessary, they call it “experimental or investigational.” Even medications that are approved by the FDA may be considered experimental or investigational by the insurer. And unfortunately, just about any drug or treatment can be considered experimental or investigational. Why? Because of how insurers define investigational. An example is when a drug helps some people but not everyone. This is true for nearly every medication on the market. In fact, it is even true for aspirin.

Do Insurance Companies Have Obligations When Members Submit Claims?

Absolutely insurers have obligations. They must thoroughly investigate a claim or request for care. Also, they must fully inquire into all possible bases that might support the request for care. Insurance companies must respond promptly to a request for care. And finally, they must have qualified health practitioners make utilization review decisions.

What Do You Do if You Receive a Remicade Health Insurance Denial?

You can always appeal a Remicade denial. But making this decision should take into consideration if you have an ERISA or non-ERISA plan. Most people don’t know what kind of plan they have. If this is the case, you can ask your plan administrator.

When an employer provides health insurance, the plan is typically an ERISA plan. However, there are exceptions. For example, none of the following is an ERISA plan: government plans, religious institution plans, individual and family plans bought via Covered California, small business plans that only include the owners, and a majority of plans bought from private insurance companies. These insurers include Blue Shield of California, Kaiser, HealthNet, UnitedHealthcare, Anthem Blue Cross, and others.

People with ERISA plans should file an appeal. But it is best to speak with an ERISA attorney before doing so. Learn more about ERISA plans and what to do here. People with non-ERISA plans have many options. Start with the reason for the denial. Learn more here.

Contact Law Offices of Scott Glovsky if You Receive a Remicade Health Insurance Denial

The Law Offices of Scott Glovsky has been representing injured consumers and Remicade health insurance denial victims for years. We focus on health insurance bad faith, catastrophic personal injury, sexual abuse and consumer-related litigation. We get justice for our clients and hold the wrongdoers accountable.