NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.
Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”). Tumor treatment field therapy devices are covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.
Code E0766 is in the frequent and substantial service payment category. Items included in this payment category are reimbursed a single monthly fee schedule amount for the device and all related supplies and accessories. Separate billing of supplies and/or accessories will be denied as unbundling.
Code A4555 is not valid for billing to Medicare. If code A4555 is billed, it will be rejected as an invalid code.
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)
Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.
Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.
If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
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.
If the supplier chooses to hold claims for the fourth and succeeding months pending receipt of information from the treating practitioner that the beneficiary received a clinical re-evaluation between the 60th and 91st day, had documented benefit from the use of, and is adhering to, TTFT treatment, those claims may then be submitted with the KX modifier.
If the supplier chooses to hold claims for the fourth and succeeding month pending receipt of information from the treating practitioner but learns that the beneficiary did not receive a clinical re-evaluation between the 60th and 91st day but rather was re-evaluated at a later date and had documented benefit from the use of, and is adhering to, TTFT treatment, those claims may then be submitted with the KX modifier but only for dates of service following the date of the clinical re-evaluation.
Documentation of adherence to TTFT shall be accomplished through direct download or visual inspection of usage data with documentation provided in a written report format to be reviewed by the treating practitioner and included in the beneficiary’s medical record. This information does not have to be submitted with the claim but must be available upon request.
If TTFT is interrupted for any reason, it is expected that the treating practitioner will document the reason for the interruption in therapy. This information does not have to be submitted with the claim but must be available upon request.
EQUIPMENT RETAINED FROM A PRIOR PAYER
When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare Fee-For-Service (FFS) program, the first Medicare claim for that item or service is considered a new initial Medicare claim. Medicare does not automatically continue coverage for any item obtained from another payer when a beneficiary transitions to Medicare coverage.
For Medicare to provide payment, the beneficiary must meet all Medicare coverage, coding, and documentation requirements for the DMEPOS items in effect on the DOS of the initial Medicare claim.
A Proof of Delivery (POD) is required for all items, even those in the beneficiary’s possession provided by another insurer prior to Medicare eligibility.
PROOF OF DELIVERY REQUIREMENTS FOR RECENTLY ELIGIBLE MEDICARE FFS BENEFICIARIES
The supplier record must document:
A statement, signed and dated by the beneficiary (or beneficiary's designee), that the supplier has examined the item, meets the POD requirements; and,
A supplier attestation that the item meets Medicare requirements.
Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.
GA, GZ, KF and KX MODIFIERS:
In all of the situations above describing use of the KX modifier, if all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for code E0766. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.
Claim lines billed without a GA, GZ or KX modifier will be rejected as missing information.
Devices coded E0766 are classified by the Food & Drug Administration as Class III devices; therefore, all claims for code E0766 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.
The supplier must enter the diagnosis code for code E0766 on each claim submitted.
Refer to the Supplier Manual for additional information on documentation requirements.
Code E0766 describes devices that generate electromagnetic fields utilized in the treatment of cancer. The electromagnetic energy generated is transmitted to the body by means of surface electrodes or transducers.
Code E0766 is inclusive of all associated supplies necessary for the effective use of code E0766 including, but not limited to, transducers/surface electrodes, lead wires, adhesive patches, connectors, conductive gel and skin preps.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.