FROM: Medicare Communications

SUBJECT: Intensity Modulated Radiotherapy (IMRT)

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 websites at www.highmarkmedicareservices.com and www.highmarkmedicareservices.com

PURPOSE
The purpose of this notice is to update the provider community of issues surrounding the Progressive Correct Action (PCA) service wide review for IMRT conducted by Highmark Medicare Services and to remind providers of the indications and limitations of coverage and medical necessity guidelines for IMRT as described in LCD 06-018 .  This notice is also intended to assist in decreasing the claims error rate and to avoid provider denials for the above listed service.

BACKGROUND
Intensity Modulated Radiotherapy (IMRT) is an advanced type of radiation therapy used to distribute radiation to the specific shape and site(s) of tumor(s), while protecting surrounding normal tissue from radiation damage. A dynamic multi-leaf collimator (DMLC) and a segmented multi-leaf collimator (SMLC) are IMRT treatment devices that deliver IMRT with many very small beams that have different intensities. IMRT is not a replacement for conventional radiation therapy; therefore the specific rationale for the use of IMRT versus other radiation methods is expected to be clearly documented in the medical record of each patient being treated with IMRT. For specific information regarding billing guidelines, indications and limitations of coverage and/or medical necessity refer to the most current Local Coverage Determination, LCD 06-018 , Intensity Modulated Radiation Therapy.

REVIEW SUMMARY
As stated in the Provider Information section of the Highmark Medicare Services website, “What’s New”, March 16, 2006, a service wide review for IMRT was initiated on March 16, 2006.  The information provided below is based on the review of submitted claims for IMRT from March 22, 2006 through August 18, 2006.

Medical review of claims for IMRT for the above mentioned dates continues to show an overall error rate of 17%.  Denials for IMRT were based on insufficient or incomplete documentation.  The following are examples of documentation that was incomplete or not submitted: 

• Rationale for IMRT and/or combination IMRT with conventional radiation therapy not clearly documented in the patient’s clinical record.
• Physician signed IMRT treatment plan and dose-volume histogram to support medical necessity for IMRT treatments not present in records submitted and reviewed.
• Daily IMRT/radiation flow sheet with patient’s name not present in records submitted and reviewed.
• Insufficient documentation to support that port films were performed.
• Insufficient documentation submitted to support the utilization of special treatment procedure (CPT 77470).
• Daily radiation treatment record does not support IMRT performed for dates of service billed
• Basic dosimetry calculation not documented (CPT 77300)
• Insufficient documentation when billing design & construction of complex treatment devices (CPT 77332-77334)
• Insufficient documentation when billing Compensated-based beam modulation tx delivery of inverse planned tx using 3 or more high resolution (milled or cast) compensator convergent beam modulated fields, per tx session (CPT 0073T)
• Insufficient documentation when billing special medical radiation physics consultation (CPT 77370)
• Insufficient documentation submitted to support the utilization of stereoscopic x-ray guidance for localization of target volume for delivery of radiation therapy (CPT 77421)     

BILLING & CODING ERRORS FOR IMRT:

• Complex treatment devices (CPT 77334) were billed on the same date of service (DOS) as the IMRT treatment plans without a modifier 59.
• CyberKnife® should not be billed with IMRT CPT codes.  Correct codes for billing CyberKnife are (HCPC 0082T) or (HCPC 0083T)
• Intensity modulated tx delivery, single or multiple fields/arcs, via narrow spatially & temporally modulated beams, binary, dynamic MCL, per tx session (CPT 77418) - billed incorrectly.  Documentation supports compensator-based beam modulation tx delivery (CPT 0073T)  
• Radiation tx delivery, three or more separate tx areas, 11-19-MeV (CPT 77414) billed incorrectly.  Documentation supported radiation tx delivery, two separate tx areas, 11-19-MeV (CPT 77409)
• The IMRT PCA review revealed that clinical trail claims were submitted without an ICD-9-CM code of V70.7. CMS requires that this code be billed with a clinical trial claim. Please refer to Provider Notice 01-083 and 00-75 for further instructions on billing clinical trials.

DOCUMENTATION REQUIREMENTS
Documentation must clearly state indications, rationale and medical necessity for IMRT. Documentation must be legible, maintained in the patient's medical record, and made available to Medicare upon request.
The following documentation must be in the medical record:

• The prescription, defining the goals and requirements of the treatment plan, including the specific dose constraints for the target(s) and nearby critical structures;
• A statement by the treating physician documenting the medical necessity for performing IMRT on the patient in question, rather than performing conventional or 3-dimensional treatment planning and delivery. This should include documentation of the need to provide protection of at least three vital structures;
• A signed IMRT inverse plan that meets prescribed dose constraints for the planning target volume (PTV) and surrounding normal tissue using either dynamic multi-leaf collimator (DMLC), segmented multi-leaf collimator (SMLC) (average number of "steps"; required to meet IMRT delivery is 5) or inverse planned IMRT solid compensators to achieve intensity modulation radiation delivery;
• The target verification methodology which must include all of the following:

• documentation of the clinical treatment volume (CTV) and the planning target volume (PTV)
• documentation of immobilization and patient positioning
• means of dose verification and secondary means of verification
• an independent check of the monitor units (MU's) generated by the IMRT treatment plan, prior to the patient’s first treatment
• fluence distributions re-computed in a phantom
• plan to account for structures moving in and out of high and low dose regions created by respiration (voluntary breath holding is not considered appropriate and the solution for movement can best be accomplished with gating technology).

All of the above documentation should be available to be reviewed by the radiation oncologist or physicist when the plan is approved.

Documentation to verify appropriate use of a multi-leaf collimator should include at least 5 ports or fluence diagrams.

Documentation to verify appropriate use of a compensator system (0073T) should include, but not be limited to, a photograph of the compensator set-up, compensator fluence diagrams for each port of therapy, and documentation of at least 3 ports per site of treatment. 

When intensity modulated radiotherapy plan (77301) is billed more than once for the same tumor, medical record documentation must support the medical necessity of the additional plan(s) and be available to the contractor upon request.  

Please note that reporting more than eight units for treatment device services (CPT 77332, 77333, and 77334) may require support documentation. Examples of acceptable documentation for additional sets of custom devices are listed below:

• Change in lesion size
• Patient repositioned
• Different volume of interest treated (identify each volume of interest)
• A boost, change in size of the volume of interest, or coned down beam is used

UTILIZATION GUIDELINES:
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

ADDITIONAL FINDINGS:
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.

To avoid 56900 denials, respond to the Additional Development Request (ADR) within 30 days. Use the ADR request letter as a guide when gathering the record documentation. Refer to Provider Notice 03-095 .
The ADR generated for the IMRT re-probe service is specific to the documentation required for the review. Listed below is the documentation requested:

1. Physician’s orders;
2. Clinical documentation of diagnosis for which radiation therapy is rendered and rationale for IMRT, including H&P and progress notes indicating patient’s response to treatment;
3. Daily treatment log of services (including evidence of radiation units, port films, etc.);
4. Physician signed IMRT treatment plan including dose-volume histogram for target and critical structures;
5. Physics consultations;
6. Results of all testing/services billed;
7. Medication record with dosage and route of administration;
8. If the claim is part of a clinical trial, provide trial name, protocol, sponsor, sponsors assigned protocol number (see PN 00-75, PN 01-083, PN 02-102); 
9. Itemized Bill.

The clinical record documentation must support the rationale for IMRT services, as well as the services provided. Additionally the diagnosis code in the record must reflect the same diagnosis code indicated on the claim and in the itemized bill.

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 IMRT conducted by Highmark Medicare Services to assist in decreasing the claims error rate and to avoid provider denials of the above listed service.

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.

REFERENCES:

• Highmark Medicare Services Local Coverage Determination: Intensity Modulated Radiation Therapy (IMRT) 
• Provider Notice 06-010: Revised Guidelines for Processing Claims for Clinical Trial Routine Care Services
• Provider Notice 01-024:  Revised Claims Processing Instructions for Medicare Qualifying Clinical Trial Claims for Managed Care (M+C) Enrollees
• Provider Notice 06-066: The Need for Accurate, Complete and Timely Responses to Additional Development Requests (ADRs)
• Intensity Modulated Radiotherapy (IMRT) / Radiation Oncology – FAQs
• CMS Manual System, Pub.100-04 Medicare Claims Processing, Change Request 3154 , Transmittal 132,
  American Medical Association Current Procedural Terminology (CPT) 2006, Professional Edition, pages 307-310.
  

Please continue to check the Highmark Medicare Services website for informational bulletins, provider notices and policy updates.

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