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”).
High frequency chest wall oscillation 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.
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 link will be located here once it is available.
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, 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.
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 discussed below.
The diagnosis code that justifies the need for these items must be included on the claim.
KX, GA, AND GZ MODIFIERS:
Suppliers must add a KX modifier to codes for an HFCWO device and accessories only if all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met.
If all of the criteria in the Coverage Indications, Limitations and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a denial as not reasonable and necessary, suppliers must enter GA on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or GZ if they have not obtained a valid ABN.
There must be information in the beneficiary’s medical record that describes in detail the underlying medical condition(s) that cause the accumulation of pulmonary secretions, the treatment interventions (for example, chest physiotherapy, postural drainage, medications used, mechanical modalities such as in-exsufflation devices (not all-inclusive)) and the effectiveness of the treatment. This information must be available upon request.
Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.
HCPCS code E0483 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM, INCLUDES ALL ACCESSORIES AND SUPPLIES, EACH) devices (HFCWO) use positive and negative pressure changes to augment peripheral and tracheal mucus movement towards the airway opening. This function is performed by extra-thoracic oscillations generated by forces external to the respiratory system. External chest wall oscillations are applied using a vest worn around the torso, which vibrates at variable frequencies and intensities, as set by the operator. E0483 devices may use differing technologies, e.g. air-pulse generators and an inflatable vest, an array of mechanical oscillators in a vest providing synchronized oscillation. E0483 is all-inclusive regardless of the technique used to produce HFCWO.
HCPCS code A7025 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM VEST, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes a complete replacement vest. This includes all components such as mechanical oscillators, electrical componentry, inflatable air sacs, connectors. Separate billing of vest components when an entire vest is replaced is incorrect coding – unbundling.
HCPCS code A7026 (HIGH FREQUENCY CHEST WALL OSCILLATION SYSTEM HOSE, REPLACEMENT FOR USE WITH PATIENT OWNED EQUIPMENT, EACH) describes the tubing used with an air pulse generator type of HFCWO device.
HCPCS code E0483 describes a complete system. Separate billing of A7025 and/or A7026 in combination with E0483 is incorrect coding – unbundling.
HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:
- Oxygen equipment
- Nebulizer and compressor
- Aspirator (suction device)
- Cough stimulator (multiple products)
If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).
Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.
The following high frequency chest wall oscillation devices HCPCS codes for individual items are included in the functionality of code E0467:
- HCPCS codes E0483, A7025, A7026
For E0467 claims with dates of service before April 3, 2020:
Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.
In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.
Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:
- Is currently in a rental month for any of the items listed above
- Owns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.
For E0467 claims with dates of service on or after April 3, 2020:
Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.
Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.
CODING VERIFICATION REVIEW
The only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.
Effective for claims with dates of service on or after January 1, 2022:
If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.
Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC) contractor for guidance on the correct coding of these items.