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November 5, 2021

Abucanumab (Aduhelm) Billing and Coding Instructions

Abucanumab is an amyloid beta-directed antibody indicated to treat Alzheimer’s disease (AD).  This drug was approved by FDA on 6/7/2021 under the accelerated approval pathway, but continued approval is contingent upon verification of clinical benefit in confirmatory trials.

Claim Submission

At this time CGS Administrators will review claims for aducanumab on a case by case basis.  Reviews will be based on FDA label, the study criteria used in the investigation of this drug and published literature related to the agent. Claims prior to FDA approval date of 6/7/2021 will be denied.

Acceptable HCPCS codes  (There is not a specific drug code for this agent),

  • J3490 (Unclassified drug) or
  • J3590 (Unclassified biologics) or
  • C9399 (unclassified drug or biological)

Reminder when using an unclassified drug HCPCS code the name and dosage of the drug is also required on the claim:

  • 1500 Claim form – item 19
  • EMC Loop field – 2300 or Loop field 2400

Documentation requirements include:

  1. Detailed medical history record
  2. Neurological and physical examination
  3. Diagnosis including how it was established and degree of impairment
  4. Medications including supplements
  5. Laboratory test to support diagnosis and exclude other concomitant disorders
  6. All related imaging studies which were performed (such as MRI, amyloid PET scan)
  7. Additional items may also be requested/required

If documentation is not submitted with the claim, CGS will release a request on your pending claim, for additional documentation (ADR).

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