Infliximab Therapy (Remicade)

Palmetto GBA Effective in 07-2003

CMS National Coverage Policy • Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

• Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

• Medicare Program Integrity Manual (PIM), Chapter 1, Section. 2. This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

• Medicare Carriers Manual, section 2049. LMRP Description Infliximab is a monoclonal antibody that binds specifically to human tumor necrosis factor alpha (TNFa). TNFa is a cytokine that is a key biologic response mediator found to be increased in such chronic and inflammatory disorders as Crohn's disease, rheumatoid arthritis, psoriatric arthropathy, and ankylosing spondylitis.

Crohn's Disease

Infliximab is approved for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had inadequate response to conventional therapy. Infliximab is approved for the reduction in the number of draining enterocutaneous fistulas in patients with fistulizing Crohn's disease.

Rheumatoid Arthritis

Infliximab is FDA approved for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate. The recommended dose of infliximab is 3mg. /kg. given as an intravenous infusion, followed with additional similar doses at two and six weeks after the first infusion and then every eight weeks thereafter. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg./kg. or treating as often as every four weeks. Infliximab should be given in combination with methotrexate. The use of infliximab without methotrexate will be covered only if the patient cannot take methotrexate due to intolerance/toxicity.

Psoriatic Arthropathy and Ankylosing Spondylitis

The coverage of infliximab has been expanded to include treatment of psoriatic arthropathy and ankylosing spondylitis where there has been inadequate response to conventional treatment as documented in the medical record. Documentation Requirements Documentation required in the medical record:

The ordering physician must document in the medical record relevant clinical signs, symptoms and abnormal laboratory test results appropriate to one of the covered indications. The patient's clinical record must indicate the conventional therapies that have been tried and the patient's past responses in an objective manner.

• For the treatment of Crohn's disease, such information may include, but is not limited to, the presence and severity of abdominal pain, the sense of well-being, the presence and severity of extra-intestinal manifestations, the degree to which diarrhea is controlled, the site and number of draining enterocutaneous fistulae, the patient's height, weight and hematocrit.

• For treatment of rheumatoid arthritis, the patient's record must include clear documentation that the patient had an inadequate response to methotrexate in reducing signs and symptoms of rheumatoid arthritis. If the patient cannot take methotrexate, the reason must be clearly documented in the medical records.

• For treatment of psoriatric arthropathy and ankylosing spondylitis, the patient's medical record must include clear documentation that the patient had an inadequate response to conventional treatment .

• The patient's medical record must document the medical necessity of services for each date of service submitted on a claim, and documentation must be available to Medicare upon request.

Appendices
Footnotes
Utilization Guidelines Crohn's Disease

Intravenous Bisphosphonate (Pamidronate) Therapy

Revision Effective Date: Services performed on and after 05/01/2002

LMRP Description: This policy describes the Medicare approved uses of intravenous bisphosphonate, a bone-resorption inhibitor that is administered by intravenous infusion.

Indications and Limitations of Coverage and/or Medical Necessity:
1. Intravenous pamidronate and zoledronic acid are approved when used in conjunction with achievement and maintenance of adequate hydration for the treatment of moderate to severe hypercalcemia associated with malignant neoplasms.
2. Intravenous pamidronate is approved when used in the management of moderate to severe Paget's disease of bone (osteitis deformans), when treatment with an oral bisphosphonate is unsuccessful or contraindicated.
3. Intravenous pamidronate and zoledronic acid are approved when used in as an adjunct to antineoplastic therapy for the treatment of osteolytic bone metastases and osteolytic lesions of multiple myeloma.
4. Intravenous pamidronate is approved when used for the treatment of disabling osteoporosis in patients meeting the following selection criteria:

A T-score on bone mass measurement below –2.5, and one of the following
Aggressive, rapidly progressive osteoporosis that is severely disabling as a result of unrelenting pain associated with an impaired ability to ambulate,
Demonstrated rapid loss of height,
Demonstrated compression fractures of the axial skeleton or peripheral fractures,
Documented allergy to shellfish and/or salmon derivatives or has failed a trial of calcitonin therapy, and
Intolerant of oral bisphosphonate therapy, or has failed to have acceptable response to a twelve month trial of oral bisphosphonate therapy, or has a degree of severity of osteoporosis that a trial of oral bisphosphonate therapy is not medically warranted.

Disclaimer: This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from internal medicine, gastroenterology, rheumatology, and family practice. As with all insurance this does not represent guarantee of payment, coverage is considered at the time of claim submission and the verification of coverage at the time of service. Before seeking treatment patients are obligated as the contracted policy holder to determine their own benefit coverage.