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November 4, 2013

Trastuzumab (HCPCS Code J9355), Kentucky – Discontinue Complex Review

The J15 Part A Medical Review department performed a service-specific complex review on claims for the drug Trastuzumab (Herceptin) (HCPCS Code J9355), bill type 13X in Kentucky.  Based on the results summarized below, the complex review will be discontinued.

Kentucky-Complex Edit Results: Trastuzumab (Herceptin) (HCPCS Code J9355)
  Charges Claims
Reviewed $377,372.40 25
Denied $58,978.42 3
Charge Denial Rate 15.6%  

The top denial reasons associated with this edit are:

5D161/5H161-No Physician's Orders

  • Reason for denial:
    • For services to be covered by the Medicare program, all diagnostic tests and services must be ordered by the physician who is treating the beneficiary's specific medical problems. Diagnostic tests or services that are not ordered by the physician are not reasonable and necessary.
  • How to prevent denials:
    • Provide documentation of the physician's order or Standard Operating Procedures (SOPs) for all services submitted, with information sufficient to enable CGS to identify and contact the ordering physician or non-physician practitioner.
    • Order(s) must be dated prior to or on the date(s) of service. For example, a surgical claim with preoperative orders must be dated for the day the tests were performed, not the date of the surgical procedure.
    • Include the following documentation when responding to Additional Development Requests (ADRs) from CGS and the services are performed or provided based on a physician's order:
      • A physician's progress note indicating what services the physician ordered
      • A history and physical that indicates what services the physician ordered
      • Ensure that each page of the beneficiary's medical record includes the beneficiary's name and any other pertinent identifying information.
      • Provide clear (legible) copies of medical records.


56900-Requested Records Not Submitted

  • Reason for denial:
    • The medical records were not received in response to an ADR in the required time frame; therefore, we were unable to determine medical necessity.
  • How to prevent denials:
    • Monitor your claim status on Direct Data Entry (DDE). If the claim is in status/location SB6001, the claim has been selected for review and records must be submitted. Please note: CGS may request records through our Medical Review or Claims departments, and other contractors such as the Zone Program Integrity Contractor (ZPIC) may also request records.  Ensure the records are submitted to the appropriate entity.
    • Alert your mail room staff to be aware of any mail you receive from CGS.
    • Be aware of the need to submit medical records within 30 days of the date on the Additional Documentation Request (ADR) in the upper left corner.
    • Gather all information and submit at one time.
    • Submit medical records as soon as the ADR is received.
    • Attach a copy of the ADR to each individual claim.
    • If you are responding to multiple ADRs, separate each response and attach a copy of the ADR to each individual set of medical records. Ensure each set of medical records is bound securely so the submitted documentation is not detached or lost.
    • Do not mail packages COD; we cannot accept them.
    • Return the medical records to the address indicated in the ADR. Be sure to include the appropriate mail code.


Individual providers with significant denials will be contacted for one-on-one education.

If you have questions regarding this review, please call the Medical Review department at 803.763.4999.

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