Appeal type: Testing
Decision: Unfavorable

We decided that the Plan does not have to pre-approve 15 fractions of 3D Conformal Radiation with image
guided radiation therapy (IGRT) to 2 metastatic sites.
You asked the Plan to pre-approve 15 fractions of 3D Conformal Radiation with IGRT to 2 metastatic sites.
You say that the requested 15 fractions of 3D Conformal Radiation with IGRT to 2 metastatic sites is medically
necessary. The Plan denied your request. The Plan says the requested 15 fractions of 3D Conformal Radiation
with IGRT to 2 metastatic sites is not medically necessary.
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically
necessary are not covered.
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 15 fractions of 3D Conformal Radiation
with IGRT to 2 metastatic sites. Our reviewer says that the requested 15 fractions of 3D Conformal Radiation
with IGRT to 2 metastatic sites is not medically necessary. Our physician reviewer found Oligometastases are
defined as a state of metastatic disease with metastases few in number and extent. The rationale for treating
oligometastases with local therapy (i.e. radiation or surgery) is to prolong disease control, and potentially
prolong life, as well as quality of life by improved cancer control. In general, small cell lung cancer, even when
the extent of disease is fairly limited, is considered to be a systemic disease best treated with systemic therapy,
with radiation used for "limited stage" intrathoracic disease and prophylactic brain radiotherapy. For extensive
stage disease, consolidative thoracic radiation is accepted based upon level 1 evidence; otherwise radiotherapy
is generally only indicated for palliation.
RTOG 0937 was a randomized Phase II trial in which patients were randomized to receive or not receive
consolidative radiotherapy to 1-4 intrathoracic or extracranial oligometastases from small cell lung cancer (10-
15 fractions). This situation is slightly different than the patient for this case (who seemingly developed a new
L4 lesion after completing treatment, and has a growing adrenal metastasis though no information is provided
about prior treatment or prior extent of disease) though is relevant in assessing the need for radiation for
oligometastases from small cell lung cancer. Because of equivalent overall survival (despite prolonged
progression free survival after radiation), the study was closed early due to crossing the futility boundary.
This enrollee would be at high risk of developing other sites of disease, thus raising the question of need for
radiotherapy for asymptomatic disease. However, it is not unreasonable to consider "prophylactic palliation" in
a patient with one enlarging site of disease, as a means to prolong disease control, prevent symptomatic
progression, and delay the need for systemic therapy. However, the need for 15-fractions of 3D radiation with
IGRT is not established versus a more standard 10-fraction 2D (or with justification 3D conformal radiation)
plan for palliation. For this case the records do not justify why a 15-fraction 3D treatment with IGRT is being
offered.
Notably the NCCN guidelines for small cell lung cancer (v2.2020) do not address oligometastases as they do
for other disease sites (non- small cell lung cancer, sarcoma,). As such treatment would not be furnished in
accordance with accepted standards of medical practice (based on level 1 evidence).
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that
Medicare rules for coverage of 15 fractions of 3D Conformal Radiation with IGRT to 2 metastatic sites have
not been met. Therefore, we decided that the Plan does not have to pre-approve 15 fractions of 3D Conformal
Radiation with image guided radiation therapy (IGRT) to 2 metastatic sites.