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 at http://www.highmarkmedicareservices.com

SUBJECT: Use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders

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

BACKGROUND
Intravenous Immune Globulin (IVIG) is a sterile solution of immunoglobulins prepared from pooled human plasma for intravenous infusion. The solution contains no less than 90% immunoglobulin, which contains a broad range of antibodies that act against bacterial and viral antigens. All IgG subclasses are represented, also included are trace amounts of IgA and IgM.

When using IVIG to treat neurological disorders, the diagnosis of the disorder must be unequivocal. There must be clinical evidence, including biopsy (muscle-nerve) data when necessary, to support the diagnosis. Other clinical data which may contribute to the diagnosis include quantitative clinical examinations, electrophysiological motor-sensory nerve conductions (EMG), CSF studies, and other ancillary tests (e.g., serum immunoprotein). Clear diagnostic criteria exist for making a diagnosis in the neurological disorders considered eligible for coverage under the Local Coverage Determinations. The reason for choosing IVIG as a treatment is expected to be stated clearly in the medical records.

Once treatment is initiated, the patient's progress is expected to be meticulously documented in the medical record. If there is initial improvement by the second course of treatment, and continued treatment is necessary, then objective clinical assessment to monitor the progress is required. Objective monitoring may use any accepted clinical method such as the MRC scale, Rankin score, ADL scores, and/or objective findings on physical exam. For Multiple Sclerosis, documentation of the number of relapses may be used. Changes in these measures, and the relationship of the change to IVIG use, are expected to be clearly documented. Subjective improvement alone is insufficient to continue IVIG.

Clinical monitoring takes clear precedence over laboratory monitoring. If clinical improvement is evident, then laboratory monitoring solely to guide IVIG therapy is not necessary.

• When clinical improvement occurs, an attempt must be made to wean the patient off the initial IVIG dosage.
• If clinical improvement is sustained at the lower dosage, an attempt must be made to discontinue the IVIG.
• Clinicians might consider it inappropriate to decrease or withhold IVIG therapy in order to assess the patient's clinical response to the medication. In such cases, the medical record must provide adequate documentation discussing why IVIG cannot be decreased or withheld.
• If clinical improvement does not occur with IVIG therapy, the medication should be stopped.

At present, IVIG is indicated as described in this policy for use in the following neurological and musculoskeletal disorders:

• Guillain-Barre Syndrome,
• Myasthenia Gravis Syndrome,
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP),
• Multiple Sclerosis,
• Dermatomyositis and Polymyositis (PM),
• Multifocal Motor Neuropathy (MMN), and
• Lambert-Eaton Syndrome.

REVIEW SUMMARY
The information provided below is based on the review of submitted claims for IVIG from January 1, 2005 through July 20, 2006.  The three LCD guidelines followed during this review period are:

Medical review of claims for IVIG for the above mentioned dates continues to show an overall error rate of 49%. 

The majority of the denials were due to insufficient or missing documentation required to make payment.  Specific documentation that is helpful in determining the rationale for the use of IVIG is listed on the IVIG Additional Development Request (ADR) letter.  An ADR is mailed to the provider requesting specific documentation for each claim to be medically reviewed.  The ADR information follows:

(All Documentation Must Be Present To Support Medical Necessity)            

• Physician's Orders.                                                      
• Clinical Documentation Of Diagnosis For Which Therapy Is Being Rendered. 
• History of Illness, Prior Treatment And Response To Treatment.
• Clinical Documentation To Support Current Use Of Med. (Examples: Recent Physician Note, Lab Results, Pre-Surgical Status)
• Identify Medication, Dose And Route, Include Documentation of Administration.
• Results of All Testing / Services Rendered.
• Itemized Bill.   

It is very important that providers obtain necessary medical documentation from third parties such as physicians or other providers, health care facilities, or suppliers 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.

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.
                                                       
Please review the Local Coverage Determinations (LCD) which discusses the indications and limitations for the use of use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders.  The Intravenous Immune Globulin (IVIG) In Neuromuscular and Musculoskeletal Disorders FAQs is also available on the Highmark Medicare Services web site to assist providers with their IVIG questions.

In regards to the review of claims from 01/01/05 to 07/20/06, the review revealed that most providers are sending in documentation when requested by the Additional Development Request (ADR) in a timely manner.  However, significant pieces of the documentation are often missing, such as documentation that supports an unequivocal diagnosis, insufficient documentation to medically justify the IVIG service, missing or incomplete history and physical, the type of IVIG is not identified in the medical records.  Specific denial reasons are made available on page four of the claim found in the FISS system. 

Please note that when using IVIG to treat neurological disorders, the diagnosis of the disorder must be unequivocal and that subjective improvement alone is insufficient to continue IVIG.

In summary, the purpose of this notice is to update the provider community of issues surrounding the Progressive Corrective Action (PCA) service wide review for the use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders conducted by Highmark Medicare Services to assist in decreasing the claims error rate and to avoid provider denials of the above listed service.

This is an LPET publication.  You may contact Highmark Medicare Services. Please continue to check the Highmark Medicare Services website for informational bulletins, provider notices and policy updates.

PROVIDER FEEDBACK SURVEY
Highmark Medicare Services LPET offers education and training related to Medical Review (MR) priority issues including:

• Issues identified through data analysis
• Provider identified MR issues
• Medicare program and policy, and
• Revisions/changes to regulations and guidelines.

Highmark Medicare Services Electronic Feedback Surveys offer an efficient method for providers to evaluate our training programs and materials, and make comments and suggestions for improving the educational process.  Please take a few moments to complete the Highmark Medicare Services Educational and Training Feedback Survey.

REFERENCES

• Local Coverage Determination (LCD 05-067 for dates of service performed on or after 01/01/2005)

• Local Coverage Determination (LCD 05-012 for dates of service 12/31/2005 – 04/12/2005)

• Local Coverage Determination (LCD 04-010 for dates of service 11/19/04 – 04/12/2005)

• Intravenous Immune Globulin (IVIG) in Neuromuscular and Musculoskeletal Disorders FAQs

If you have any questions regarding this bulletin, please contact the appropriate Customer Contact Center at:

Maryland Providers: 1-866-488-0545
Pennsylvania Providers: 1-800-560-6170