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July 7, 2014

Trastuzumab (HCPCS Code J9355) – Ohio - Discontinued

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

Ohio-Complex Edit Results:  Trastuzumab (Herceptin) (HCPCS Code J9355)










Charge Denial Rate



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.


5D164/5H164 - No Documentation of Medical Necessity

  • Reason for denial:
    • This claim was fully or partially denied because the documentation submitted for review does not support the medical necessity of some of the services billed.
  • How to prevent denials:
    • Submit all documentation related to the services billed which support the medical necessity of the services.
    • A legible signature is required on all documentation necessary to support orders and medical necessity.
    • Use the most appropriate ICD-9-CM codes to identify the beneficiary’s medical diagnosis.

For more information, refer to:

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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