Reimbursement FAQs: Coding System Updates and Other News

What is the reimbursement code for the newly approved wilate, manufactured by Octapharma? How are insurance companies covering it?

In January, the U.S. Food and Drug Administration granted Octapharma orphan drug exclusivity for wilate (von Willebrand Factor/Factor VIII Concentrate, Human) for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD), as well as in patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

From the Octapharma website (www.wilateusa.com), the reimbursement codes are as follows:

• Outpatient Prospective Payment System Payment Pass Through Code — C9267 (inj, wilate) per 100 IU VWF:RCof
• Part B Medicare HCPCS Code — J3590 (miscellaneous biologic) per 1 IU VWF:RCof

According to one large insurer, medical necessity for Factor VIII for the treatment of von Willebrand disease is considered medically appropriate if all of the following criteria are met:

1) When the disease is categorized as any one of the following: Type I (partial quantitative deficiency of von Willebrand factor) where the use of desmopressin is known/suspected to be inadequate; Type 2 (including subsets A, B, M or N with qualitative defects of von Willebrand factor); or Type 3 (complete deficiency of von Willebrand factor);

2) When the request is specifically approved for the treatment of bleeding episodes in adult and pediatric individuals with von Willebrand disease (e.g., wilate).

A major patient concern, which was found in one insurer’s drug formulary, is that wilate, along with several other antihemophilic factor products, is listed in a Tier 5 level. At this level, the patient is responsible for a 33 percent copayment. While patient liability can be limited by an out-of-pocket maximum, physicians ordering wilate or any other specialty drug should be aware of the costs patients could face. To assist in reimbursement matters, Octapharma has experts available specifically for wilate. They can be reached by emailing [email protected], calling (800) 554-4440 or faxing (800) 554-6744.

Is Medicare going to cover Fluzone High-Dose?

Fluzone High-Dose, an inactivated influenza vaccine containing an increased amount of antigen compared with standard-dose influenza vaccines, is available for the first time and approved by the Food and Drug Administration for adults age 65 and older who have a reduced antibody response to influenza vaccination compared with younger adults. Although the Advisory Committee on Immunization Practices (ACIP) recommends a yearly influenza vaccine for all persons over the age of 6 months, it does not currently specify a particular vaccine over another.

Medicare pays for one seasonal influenza immunization each influenza season for all beneficiaries.No coinsurance or copayment applies to this benefit, and an individual does not have to meet his or her deductible to receive the benefit.In addition, Medicare pays separate rates for the administration and cost of the influenza vaccine.

Medicare Part B will reimburse for Fluzone High-Dose for beneficiaries 65 and older using a CPT (current procedural terminology) code of 90662. As of the date of this writing, the reimbursement rate was $29.21. The Centers for Medicare and Medicaid Services (CMS) was expected to issue new average sales price (ASP) updates on October 1, 2010. For current CMS pricing, go to www.cms.gov/McrPartBDrugAvgSalesPrice/01a19_2010aspfiles.asp#TopOfPage.

Some insurance companies will cover off-label uses for Rituxan, while others will not. In what situations will Medicare cover Rituxan?

Rituxan is a monoclonal antibody that targets a specific protein, known as CD20, on the surface of B cells. Rituxan binds to CD20 and is believed to work with the body’s own immune system to attack and kill the marked B cells. Food and Drug Administration (FDA)-approved indications for the uses of Rituxan include chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) and nonHodgkin’s lymphoma (NHL).

In general, private insurers will cover at least what Medicare will cover. According to the Centers for Medicare and Medicaid Services, Medicare coverage for Rituxan is considered medically necessary for the following FDAapproved indications.

Non-Hodgkin’s lymphoma (NHL):

• Patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, NHL as a single agent
• Previously untreated diffuse large Bcell, CD20-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens
• Previously untreated follicular, CD20- positive, B-cell NHL in combination with CVP chemotherapy
• Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent after first-line treatment with CVP (cyclophosphamide and vincristine) chemotherapy

Rheumatoid arthritis (RA):

• In combination with methotrexate to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely-active RA who have had an inadequate response to one or more TNF antagonist therapies

Chronic lymphocytic leukemia (CLL):

• In combination with fludarabine and cyclophosphamide (Fc) for the treatment of patients with previously untreated and previously treated CD20- positive CLL

Medicare also will consider the use of Rituxan as medically reasonable and necessary for the FDA-approved uses, as well as the following off-labeled indications:

• Low-grade or follicular CD20-positive, B-cell non-Hodgkin’s lymphomas (re-induction treatment appropriate for responders and patients with stable disease)
• Intermediate and high-grade NHL when used as a single agent, in combination with a CHOP chemotherapy regimen, or in combination with other agents active in the disease
• Immune or idiopathic thrombocytopenia purpura
• Evans syndrome • Waldenstrom’s macroglobulinemia
• Refractory thrombotic thrombocytopenic purpura (TTP) for patients who do not respond to plasmapheresis
• Autoimmune hemolytic anemia condition that is refractory to conventional treatment (e.g., corticosteroid treatment and splenectomy).

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