Revision Date: January 18, 2007

This bulletin should be shared with all health care practitioners and managerial members of the provider/supplier staff.  Additional copies may be downloaded from our website.

This bulletin has been updated. Please refer to Provider Notice 07-006.

PURPOSE:

The purpose of this notice is to update the provider community of issues surrounding the Progressive Correct Action (PCA) service wide review for Infliximab conducted by Highmark Medicare Services and to remind provider of the indications and limitations of coverage and/or medical necessity guidelines for Infliximab.  This notice is also intended to assist in decreasing the claims error rate and to avoid provider denials of the above listed service.

BACKGROUND:

Infliximab is a murine-human monoclonal antibody which binds to and neutralizes the effects of tumor necrosis factor alpha. 

Infliximab may be indicated for reducing signs and symptoms, and inducing and maintaining clinical remission, in patients with moderately to severely active Crohn's disease who have inadequate response to conventional therapy.

Infliximab may be indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.

Infliximab, in combination with methotrexate, may be indicated for the reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate.

Infliximab may be indicated for the treatment of ankylosing spondylitis in patients with evidence of inflammatory disease.

Infliximab may be indicated for the treatment of psoriatic arthritis.

Infliximab may be indicated for the treatment of psoriasis.

Infliximab is indicated for the treatment of inflammatory bowel disease arthritis.

Infliximab is also indicated for the treatment of chronic ulcerative colitis, whether localized or diffuse, when proven refractory to conventional therapy. 

REVIEW SUMMARY:

As stated in the Provider Information section of the Highmark Medicare Services website, "What's new",  a service wide review for Infliximab was initiated on 01/13/2006.  The information provided below is based on the review of submitted claims for Infliximab from July 1, 2006 through December 31, 2006.

Medical review of claims for Infliximab for the above mentioned dates continues to show an overall error rate of 48%.  The majority of the denials were due to a lack of documentation to support that treatment with Infliximab was medically reasonable and necessary.  Specific documentation that is helpful in determining the rationale for the use of Infliximab is as follows:

History, progress notes and clinical data
The history, progress notes, and clinical data present a comprehensive overview of the patient’s disease process and service to support the medical necessity and the rationale for the use of Infliximab.  Progress notes should be recent enough to indicate that the patient is being evaluated to determine the effectiveness of the treatment.  The history should document or discuss the disease process for which the patient is receiving the Infliximab.

Documentation regarding the patient’s response to conventional therapy prior to the use of the Infliximab. 
Uses of Infliximab that may be reasonable and necessary are described in LCD 06-044.  Some of the indications include a requirement for prior treatment with other agents.  In other words, Infliximab is not covered as a first line treatment.  Documentation describing those prior therapies, the patient's tolerance of, and response to those therapies, is necessary for payment of the current use of Infliximab. 

Specifically, for those patients who are receiving Infliximab for the treatment of rheumatoid arthritis, documentation regarding past or present use of Methotrexate in conjunction with Infliximab is required. 

Again, please review the LCD which discusses the indications and limitations for the use of Infliximab in rheumatoid arthritis.  Documentation of concurrent medication use is necessary for the review of Infliximab claims. 

This review revealed that most providers are sending in documentation when requested by the Additional Development Request (ADR).  However, significant pieces of the documentation are often missing, such as the convention therapy prior to the use of Infliximab, the most current progress notes, or other clinical data to support the service. 

It is very important that providers contact third parties such as physicians or other providers, health care facilities, or suppliers and request a copy of the medical documentation necessary to fully support the services billed to Medicare.  It is the responsibility of the provider submitting the claim for payment to obtain all the requested documentation, regardless of where the records are kept.

The ADR generated for the Infliximab service is specific to the documentation required for the review.  Listed below is a sample of the documentation requested:

1. Physician’s orders
2. History/progress notes or other clinical data to support the medical necessity/rationale for the use of infliximab and to validate the diagnosis on the claim.
3. Treatment/medication record with dosage and method of administration and progress notes of the response to treatment.
4. Documentation of the response to conventional therapy prior to the use of infliximab.
5. Documentation of the current or past use and response to methotrexate.
6. Results of all testing/services billed including radiographic and/or endoscopic results to support the diagnosis billed.
7. Clinic/treatment room records.
8. Itemized bill.

When a request for Additional Development Request (ADR) is received, please review and provide the requested documentation prior to submission of claims in order to ensure appropriate review of all information supporting medical necessity for the services billed.

Again, the purpose of this notice is to update the provider community of issues surrounding the Progressive Corrective Action (PCA) service wide review for Infliximab conducted by Highmark Medicare Services to assist in decreasing the claims error rate and to avoid provider denial of the above listed service.

REFERENCES:

LCD 06-028 for dates of service performed on or after 04/28/2006

Revised LCD 06-044 effective for dates of services performed on or after 10-16-06.

If you have any questions regarding this bulletin, please contact the Customer Contact Center at 1-800-560-6170.