| Documentation
Requirements back
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The most accurate and specific diagnosis
code(s) must be submitted on the claim. The patient’s medical record
should indicate the specific signs/symptoms, level of functional
impairment, and other clinical data supporting the diagnosis code(s)
used. The medical record must clearly support medical necessity by
including current relevant clinical signs and symptoms. It must also
include all prior conventional treatments and the response to these
treatments. Documentation must include the date and dose
administered for all doses in the current series, and the date the
most recent prior series was completed. If the recommended dose of
3-5mg/kg every 8 weeks has to be exceeded, the provider needs to
document the findings and considerations leading to this decision
and the effectiveness of the intervention. In case of no significant
improvement after 14 weeks, the dose should be reduced again
followed by an overall assessment of the efficacy of Remicade in
this particular situation.
1. For the treatment of
moderately to severely active Crohn's Disease for the reduction of
signs or symptoms in patients who have had an inadequate response to
conventional therapy, the patient's medical record must include, at
minimum, the following information:
a. Radiographic and/or endoscopic clinical diagnosis of
Crohn's disease
b. Patient's response to conventional
therapy (such as corticosteroids, 5- aminosalicylates, and/or
6-mercaptopurine/azathioprine)
c. Patient's response to
the initial dose (when billing for subsequent doses)
2. For
the treatment of patients with fistulizing Crohn's Disease, for the
reduction in the number of draining enterocutaneous fistula(s), the
patient's medical record must contain, at minimum, the following
information:
a. Radiographic and/or endoscopic clinical diagnosis of
Crohn's disease
b. Documentation of signs, symptoms and
location of fistula(s)
c. Patient's response to
conventional therapy
d. Patient's response to the previous
dose (when billing for subsequent doses)
3. For the
treatment of rheumatoid arthritis in adults in combination with
methotrexate in patients who have had an inadequate response to at
least four months of methotrexate therapy, documentation must
include at minimum, the following information:
a. Diagnosis of rheumatoid arthritis made in accordance
with the American College of Rheumatology Criteria for the
Classification and Diagnosis of Rheumatoid Arthritis.
b.
Patient's inadequate response to at least 4 months of methotrexate
therapy
c. Documentation that the patient received at
least 7.5 mg of methotrexate a week for 3 months prior to the
initiation of infliximab therapy.
d. Notation in the
patient’s medical record that the patient continues on their
stable dose of at least 7.5 mg/week of methotrexate in combination
with infliximab therapy.
e. For patients continued on
infliximab therapy beyond 30 weeks, physician documentation of the
patient's improvement using objective measures such as standard
rheumatoid arthritis activity indexes (such as Lansbury, Ritchie,
Paulus or the American College of Rheumatology Responder Index) is
necessary.
f. Patient’s age
g. Documentation must
include the patient's response to both prior doses in the series
and to prior series of doses. This includes objective or otherwise
measurable assessment of the degree of joint activity before,
during and after the series of treatments with Remicade.
4.
For the maintenance treatment of Crohn's disease in patients who
have had an inadequate response to conventional therapy,
documentation must include at minimum, the following information:
a. Patient's inadequate response to maintenance
conventional therapy.
b. Notation in the patient’s medical
record that the patient continues on their conventional therapy.
c. For patients continued on infliximab therapy beyond 30
weeks, physician documentation of the patient's improvement and
documentation that reflects improvement over a conventional
therapy baseline.
d. Patient’s age
e.
Documentation must include the patient's response to initial doses
in the series and to prior series of doses. This includes
objective indicators (frequency of diarrhea, cramping, weight
loss/gain, etc.) to the extent possible.
The following
should be provided if a record is selected for medical review:
- History and Physical
- M.D. orders/progress notes
- Diagnoses
- Test reports
- Drug administration /clinical notes
- Itemization of charges
5. When used for the
treatment of psoriasis in the absence of documented psoriatic
arthropathy, the service will be denied due to the lack of
supportive medical evidence.
6. For the treatment of psoriatic arthropathy,
ankylosing spondylitis, and ulcerative colitis the patients medical
record must include:
- diagnostic testing used to verify the patient's clinical
diagnosis
- documentation regarding the details of the patient's disease
course
- previous conventional therapy and the patient's
response
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| Appendices back
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LINK TO QUESTIONS AND ANSWERS (COMMENTS) ABOUT THIS
POLICY:
Frequently Asked
Questions
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| Utilization
Guidelines back
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| Sources of Information and
Basis for Decision back
to top |
Cigna, Part B Carrier. Remicade LMRP
2001-03
Empire Medicare Services. Infliximab LMRP DR005E01
First Coast Service Options, Inc. Infliximab (Remicade) LMRP
Trailblazer Health Enterprises policy, Infliximab Therapy
(Remicade) 1-44A-R1 LMRP
Veritus Medicare Services.
Infliximab LMRP 00-010
Mosby's Drug Consult, copyright 2002
Mosby, Inc. Infliximab (003410)
Sands, Bruce. "Novel
Therapies for Inflammatory Bowel Disease". Gastroenterology Clinics.
Vol. 28, No. 2, 1999.
Keystone, Edward. "Tumor Necrosis
Factor-alpha Blockade in the Treatment of Rheumatoid Arthritis".
Rheumatic Diseases Clinics of North America Vol. 27, No. 2, May
2001.
Stein, R.; Lichtenstein, Gary. "Medical Therapy of
Crohn's Disease" Surgical Clinics of North America. Vol. 81 No. 1,
February 2001.
Van Dulleman HM, Van Deventer SJH, Hommes DW
et al. Treatment of Crohn’s disease with anti-tumor necrosis factor
chimeric monoclonal antibody (cA2). Gastroenterology
1995;109:129-35.
Brandt J, Haibel H, Cornely D, et al:
Successful Treatment of Active Ankylosing Spondylitis with the
Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Infliximab.
Arthritis Rheum. 2000 Jun; 43(6): 1346-52.
Stone M, Salonen
D, Lax M, et al: Clinical and Imaging Correlates of Response to
Treatment with Infliximab in Patients with Ankylosing Spondylitis. J
Rheumatol. 2001 Jul; 28(7): 1605-14.
Antoni C, Dechant C,
Lorenz H, et al: Successful Treatment of Severe Psoriatic Arthritis
With Infliximab, American College of Rheumatology, Nov. 16,
1999
Dechant C, Antoni C, Wendler J, et al: One Year Outcome
of Patients with Severe Psoriatic Arthritis Treated with Infliximab,
ACR Annual Scientific Meeting, Philadelphia, PA, Oct 27,
2000
FDA drug label revision 9/12/2005
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| Advisory Committee Meeting
Notes back
to top |
Public Open Meeting to discuss the draft
policy was held 07/09/2002.
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 as well as provider
(facility) representatives. |
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| Start Date of Comment
Period back
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| 06/05/2002 |
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| End Date of Comment
Period back
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| 07/20/2002 |
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| Start Date of Notice
Period back
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| 08/13/2002 |
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| Revision History
Number back
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| L1948a |
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| Revision History
Explanation back
to top |
10/25/2005 Coverage of ulcerative colitis
added to LMRP Description, Indications Summary and Indications and
Limitations of Coverage and/or Medical Necessity. Added dosing
recommendations for ulcerative colitis to LMRP descriptions and
Indications Summary. Added ICD-9 codes 556.0, 556.1, 556.5, 556.6 to
ICD-9 Codes that Support Medical Necessity. Added medical record
requirements for ulcerative colitis to Documentation Requirements.
Added supporting references to Sources of Information and Basis for
Decision.
03/01/2005 Coverage of psoriatic arthropathy and
ankylosing spondylitis added to LMRP Description, Indications
Summary and Indications and Limitations of Coverage and/or Medical
Necessity. Deleted reference to treatment of psoriatic arthropathy
and ankylosing spondylitis as investigational from Limitations.
Added dosing recommendations for ankylosing spondylitis to LMRP
descriptions and Indications Summary. Added ICD-9 codes 696.0
Psoriatic Arthropathy and 720.0 Ankylosing Spondylitis to ICD-9
Codes that Support Medical Necessity. Added medical record
requirements for psoriatic arthropathy and ankylosing spondylitis to
Documentation Requirements. Added supporting references to Sources
of Information and Basis for Decision.
08/10/2004 Crosswalked
referenced to Online Manual
03/25/2003 Replaced the 90780 and
90781 infusion codes under "Coding Guidelines" with Q0081 (MHM
442.7)
This LCD was converted from an LMRP on
12/8/2005 |
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| Last Reviewed On
Date back
to top |
| 06/21/2007 |
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| Related
Documents back
to top |
Article(s)
A37946 - Infliximab
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| LCD
Attachments back
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