Appeal type: Practitioner Services
Decision: Favorable

We decided that the Plan has to pre-approve an additional 14 fractions of intensity-modulated radiation therapy (IMRT).

You asked the Plan to pre-approve the additional 14 fractions. You say that the requested treatment plan would be the best option for this enrollee. The Plan denied your request. The Plan says that it is felt that a treatment plan with fewer fractions is more reasonable and only 28 fractions will be approved.

The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item or service, then that item or service will be covered when it is medically necessary.

We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the additional 14 fractions. Our reviewer says that the requested items/services are considered medically reasonable and necessary in this case. Our physician reviewer found this patient, with favorable risk prostate cancer, was offered definitive radiotherapy with IMRT and image-guided radiotherapy (IGRT) to a dose of "70-77.4 Gy in 28-43 fractions." At issue is the number of fractions requested (43). The insurance form specifies 30 fractions for phase 1 and 13 for phase 2. A total of 28 fractions are approved and the remainder are disputed here. For this case, the issue is the appropriateness of 42 fractions vs moderate hypofractionation (preferred by the Plan).

For prostate cancer, the National Comprehensive Cancer Network (NCCN) guidelines offer preferred dose fractionations of 3 Grays (Gy) x 20, 2.7 Gy x 26, and 2.5 Gy x 28. Conventional fractionation remains an acceptable alternative with 1.8-2 Gy for 37-45 fractions.

The NCCN guidelines summarize the data on hypofractionation stating "moderately hypofractionated image-guided IMRT regimens (2.4-4 Gy per fraction over 4-6 weeks) have been tested in randomized trials, and their efficacy has been similar or non-inferior to conventionally fractionated IMRT, with on trial showing fewer treatment failures with a moderately hypofractionated regimen. In addition, efficacy results varied among the trials, with some showing noninferiority or similar efficacy and others showing that hypofractionation may be less effective than conventional fractionation schemes." Other guidelines indicate that moderate hypofractionation should be offered, but that physicians should discuss the limited follow-up beyond five years for most existing studies evaluating moderate hypofractionation.

In the current case, the criteria for medical necessity are met as the treatment with 43 fractions of IMRT would be "furnished in accordance with accepted standards of medical practice."

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the additional 14 fractions have been met. Therefore, we decided that the Plan has to pre-approve an additional 14 fractions of intensity-modulated radiation therapy (IMRT).

If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will send you a letter.