E0766 Medicare coverage

Local coverage indication

INITIAL COVERAGE FOR NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME: Tumor treatment field therapy (E0766) is covered for the treatment of newly diagnosed Glioblastoma Multiforme (GBM) only when all of the following criteria are met: The beneficiary has histologically confirmed (World Health Organization (WHO) grade IV astrocytoma), newly diagnosed, supratentorial GBM; and, The beneficiary has received initial treatment with maximal debulking surgery (when feasible), followed by chemotherapy and radiotherapy; and, Tumor treatment field therapy is initiated within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy, whichever is later; and, The beneficiary has no evidence of progression by Response Assessment in Neuro-Oncology (RANO) criteria; and, The beneficiary has a Karnofsky Performance Score (KPS) of at least 70; and, The beneficiary will use TTFT for an average of 18 hours per day. If all of the coverage criteria above are not met, claims for code E0766 will be denied as not reasonable and necessary. CONTINUED COVERAGE FOR NEWLY DIAGNOSED GBM BEYOND THE FIRST THREE MONTHS OF THERAPY: Continued coverage of TTFT (E0766) beyond the first three months of therapy requires that no sooner than the 60th day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary is continuing to use and is benefiting from TTFT. Documentation of clinical benefit is demonstrated by: In-person clinical re-evaluation by the treating practitioner; and, Objective evidence of adherence to therapy, reviewed by the treating practitioner. Adherence to therapy is defined as the use of TTFT for an average of 18 hours per day (excluding days the treating practitioner has documented a medical need to limit or interrupt treatment). If the above criteria are not met, continued coverage of TTFT will be denied as not reasonable and necessary.

Excerpt from LCD L34823 version 27, effective 01/01/2020. CMS LCD L34823.

From A52711

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. INITIAL COVERAGE (FIRST THREE MONTHS): On claims for the first through third months, suppliers must add a KX modifier to code E0766 only if all of the criteria in the “Coverage Indications, Limitations and/or Medical Necessity” section of the related LCD ("Initial Coverage") have been met. CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY: On the fourth month’s claim (and any month thereafter), the supplier must add a KX modifier to code E0766 only if both the "Initial Coverage" criteria and the "Continued Coverage" criteria in the “Coverage Indications, Limitations and/or Medical Necessity” section of the related LCD have been met. If the supplier does not obtain information from the practitioner that the beneficiary has demonstrated benefit from the use of, and is adhering to, TTFT treatment in time for submission of the fourth or succeeding months’ claims, the supplier may still submit the claims, but a KX modifier must not be added.

CMS source A52711

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426