Reimbursement FAQs: Documentation, Medicare Coverage, Factor Products and Qualifiers

What is considered good documentation?

Proper and complete documentation can help avoid insurance denials and delays. When writing a letter of necessity, it is helpful to reference the insurance policy. Documentation should address the insurance policy’s qualifications for treatment. In general, proper documentation should include:

• a patient history and physical
• physician office/progress notes
• test results with written interpretation
• accurate patient weight in kilograms
• documentation of prior treatment therapies and results
• evidence of blood level results that demonstrate a specific deficiency or disease
• history of recurrent and severe infections (when appropriate for the diagnosis); this includes chart notes, culture reports, lab results and radiological confirmation of infections. (Some insurance policies and Medicare local coverage determinations specifically state that calling in a prescription for antibiotics is not proof of infection.) • current effectiveness of therapy • goals and/or treatment plan It also is helpful to provide specific medical studies supporting the treatment plan.

Will insurers or Medicare cover IVIG for polymyositis or dermatomyositis?

Yes. Immune globulin (IG) treatments for dermatomyositis and polymyositis are covered disease states, but not as a first line of therapy. In general, insurers and Medicare look for documentation that shows other treatments have been tried and have failed. Patients must be unresponsive to steroids and immunosuppressants, intolerant to steroids and/or immunosuppressives, or have serious side effects from steroids and/or immunosuppressives. For continued IG treatment, a patient’s record must show that there was a measurable response within six months of infusing IG, or its use will no longer be considered medically necessary.

What do insurers routinely require for the coverage of a C-1 inhibitor to treat hereditary angioedma (HAE)?

Until recently, there were few effective treatments for patients in the United States suffering with HAE to prevent or stop severe swelling and pain brought on by attacks. Physicians now have the option to treat patients with three new medications:

1. Berinert by CSL Behring, which is FDA-approved fortreating acute laryngeal and abdominal HAE attacks

2. Cinryze by ViroPharma, which is indicated for the routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE

3. Kalbitor by Dyax, which is FDAapproved to treat acute HAE attacks in patients 16 years of age and older

As with all expensive treatments, most insurers require a preauthorization before they will approve the start of treatment with a C-1 inhibitor. Providers must submit documentation that supports the diagnosis. According to one major insurer, documentation about the patient should include:

• antigenic C-1 inhibitor, functional C-1 inhibitor and C-4 levels
• history of frequent or severe attacks
• previous treatment failure or contraindication to Danazol or Stanozolol In addition, reauthorization requests should include documentation showing a decrease in attacks and/or severity of attacks

What are the key issues to consider when choosing factor (blood clotting) products?

Treating one hemophilia patient can cost hundreds of thousands of dollars each year, and, in especially severe cases, that amount can be reached each month. Understandably, these high-dollar cases draw passionate attention from providers, patients, manufacturers, case managers and insurers. Except when considering lifetime caps, cost may not be the biggest driver behind product choice for the patient. Because many hemophilia patients will reach their yearly out-ofpocket maximums before the flowers bloom in the spring, their yearly out-ofpocket requirements are met early, and costs beyond those requirements do not influence product choice, unless they affect their lifetime cap. Many hemophilia patients understand that being welleducated about their treatment is essential to successful treatment and preservation of good health. Their chief concerns about coagulation products include:

• shelf-life with and without refrigeration
• whether one product works better than another
• safety track record of the manufacturer
• diluent quantity per vial and/or dose (many patients feel less is best)
• vial size (fewer vials means less storage space and less time spent on treatment preparation)
• derivation: recombinant or human plasma-based

Unlike many other disorders, however, there appears to be few, if any, official formularies regarding choice of products for hemophilia. Like other well-known plasma products, there are no generics — only brand-named products. While many insurers do place factor products in a Tier II or III level of reimbursement, most put all brands on one tier level, usually the higher tier. Regardless of the apparent lack of formulary policies that frequently drive brand choice, patients report being asked to switch brands by both insurers and providers.

When a provider or patient is asked to switch brands, it is important to ask questions and get answers before changing. For instance, they should ask why the brand switch is being requested and who is making the request, and how the change will affect the patient. They should also ask to receive the policy and the request to change brands in writing, and the patient should receive copies, too. In the end, how well the patient responds and follows treatment is ultimately what is going to be most cost-effective for all concerned.

What are the qualifiers insurers consider medically necessary to treat alpha-1 antitrypsin deficiency (AAT) with an alpha 1-proteinase inhibitor?

Alpha-1 antitrypsin deficiency (AAT) is an inherited disorder that can cause lung disease in adults and liver disease in adults and children. Symptoms of AAT include wheezing, difficulty breathing, shortness of breath, unintentional weight loss, fatigue, recurrent respiratory infections, a barrel shaped chest and a chronic cough.

Delayed or poor treatment can lead to permanent disability and premature death. Patients with this type of deficiency are often misdiagnosed as having chronic obstructive pulmonary disease (COPD) or asthma. The World Health Organization recommends all patients diagnosed with COPD or asthma be tested for AAT.

The following is an excerpt from one major insurer’s policy detailing what documentation warrants treatment of AAT with an alpha-1 proteinase inhibitor:

• the patient’s alpha1-antitrypsin (AAT) concentration must be less than 80 milligrams per deciliter (mg/dl) [or greater than 11 micromolar (μM)]
• the patient’s obstructive lung disease, as defined by a forced expiratory volume in one second (FEV1) of 30 percent to 65 percent of predicted or a rapid decline in lung function, must be defined as a change in FEV1 of greater than 120 mL/year
• the patient must be a non-smoker For a list of standards of diagnoses and management of patients with AAT, go to www.alpha-1foundation.org/healthcare/?c=03-ATSERS-Standards-PDFs.