Increasingly, payers require patients to try and fail “first-line” treatments before payers approve more costly treatments. Some strategies are listed below:

  • Include supporting articles from the literature supporting off-label use.
  • Ask physicians to supply statements on why the first-line therapy is not appropriate.
  • Request that patients pay a deposit, which can be refunded if the appeal is successful.

Increasingly, payers require clinical proof that patients already tried less costly “first-line” treatments before approving more expensive treatments. Without this documentation, they’ll deny the claims.

“Plan-specific medical necessity criteria often require documentation showing that the patient has tried and failed first line of therapy or treatments,” says Junko I. Fowles, CHAM, supervisor of patient access and financial counseling at the Huntsman Cancer Institute in Salt Lake City. Typically, payers approve the more expensive treatments if the patient has failed the first line of therapy.

“As for commercial insurance, if the first line of therapy hasn’t tried or failed, we almost always receive a first denial,” Fowles notes. A different process is used for Medicare patients.

“In the case of Medicare, we don’t get pre-approval. Instead, we will make sure it meets CMS medical necessity criteria,” Fowles explains.

This would mean the treatment is covered.

Off-label Drugs

The same problem occurs if providers order drugs for off-label use. These include Rituxan infusion for idiopathic thrombocytopaenic purpura and olaratumab infusion for pancreatic cancer.

“If it’s determined that the treatment is off-label and, therefore, non-covered, the patient is given an Advanced Beneficiary Notice making them aware of the possible financial liability,” Fowles adds. Once the claim is denied, the following actions occur:

1. Patient access staff notifies the treating provider to initiate an appeal process.

“Some providers argue that the treatment recommended is more cost-effective than the first-line therapy,” Fowles says. Also, there may be a valid reason why the first-line therapy is not appropriate for a certain patient. This documentation is included in the appeal.

2. Patient access submits a letter of medical necessity with additional documents.

This typically includes articles and literature supporting the use of off-label therapy, or the use of the “second line” of therapy without failing the first line of therapy. If a second denial is received, patient access is undeterred, and files the second level of appeal. About half the appeals are successful.

3. Financial counselors explain the situation to patients.

Staff use this scripting: “Unfortunately, the recommended treatments do not meet your insurance’s medical necessity criteria, and it may end up not being covered at all. We are proceeding with the appeal process. However, I would like you to be informed of the ‘non-covered/denied’ status. We would like to know if you can make a deposit of $______ prior to the service. There will be a financial assistance program available to assist pay the remaining balance. If the appeal is successful, we will refund the full deposit and any payments made toward the treatments.”

Cancer treatments are time-sensitive. Delaying treatments because of issues with insurance coverage usually isn’t an option.

“Financial counselors meet with the patient to discuss payment plans,” Fowles says. “We are as transparent as possible.”


  • Junko I. Fowles, CHAM, Division of Revenue Cycle Support Services, Huntsman Cancer Institute, Salt Lake City. Phone: (801) 587-4036. Email: Junko.fowles@hsc.utah.edu.