|Medicare Part B Coverage
Remicade and Pamidronate
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
• 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
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
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
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
• 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.
Utilization Guidelines Crohn's Disease
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
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
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
Demonstrated rapid loss of height,
Demonstrated compression fractures of the axial skeleton or peripheral
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.
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