NON-MEDICAL NECESSITY COVERAGE & 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”).
Respiratory assist 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.
Accessories are separately reimbursable when used with E0470, E0471.
No aspect of a home sleep test, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests or to tests conducted in facility-based sleep laboratories.
Services of a respiratory therapist are non-covered under the DME benefit.
A liner used in conjunction with a PAP mask is considered comfort/convenience item. There is no additional payment for liners used with a PAP mask. These products should be coded A9270 (Noncovered item or service) in accordance with the Medicare Benefit Policy Manual (CMS Pub. 100-02) Chapter 15, Section 110.1.
Claims for A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) are denied as statutorily non-covered (No Medicare benefit).
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
REPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT:
For claims for replacement accessories (e.g., interfaces, tubing, filters, humidifier chambers), if Medicare paid for the base RAD initially (i.e., for 13 months of continuous use), the medical necessity for the beneficiary-owned base RAD is assumed to have been established. Therefore, to make a payment determination, there must only be documentation that the base DME item continues to meet medical need; and (2) The replacement of specific accessories or furnishing of new accessories remain medically necessary and are essential for the effective use of the base DME.
Documentation of continued medical need for the base item must come from the treating practitioner’s records. The supplier's documentation records must support the need to replace the accessory to maintain the equipment's functionality and meet the beneficiary's medical need.
This guidance does not apply RADs when Medicare did not originally provide payment for the base item. In cases where Medicare did not originally pay for the DME item, all coverage, coding and documentation requirements in effect for the date of service (DOS) on the claim under review must be met (see Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD).
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.
Proper use of modifiers is discussed below. Specific modifiers must be used and differ depending on whether or not the requirements outlined in the documentation section have been met.
Where permitted, KX must be added to codes E0470 and E0471 and codes for accessories used with E0470 and E0471. The KX modifier must not be used until the required documentation has actually been obtained and entered into the supplier’s files.
On claims for the first through third months, suppliers must add a KX modifier if all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.
On the fourth month’s claim (and any month thereafter), the supplier must add a KX modifier if all the "Initial Coverage" criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have been met and the treating practitioner's signed and dated statement described in the Coverage Indications, Limitations, and/or Medical Necessity above, has been obtained for the supplier's files.
If the completed and signed treating practitioner statement is not in the supplier’s files 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. However, if the supplier chooses to hold claims for the fourth and succeeding months until the completed and signed forms are obtained, those claims may then be submitted with the KX modifier, so long as their answers indicate continued compliant use of and benefit from the therapy, according to the Coverage Indications, Limitations, and/or Medical Necessity section.
GA AND GZ 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 the RAD equipment (E0470 or E0471) and accessories. When there is an expectation of a medical necessity 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.
A respiratory assist device (RAD) without backup rate (E0470) delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal, oral, or facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. A respiratory cycle is defined as an inspiration, followed by an expiration.
A respiratory assist device (RAD) with backup rate (E0471) delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. In addition, it has a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.
HCPCS code A4604 describes tubing used with a heated humidifier and has a heated wire running the length of the tubing. It is designed for use with a positive airway pressure device and a non-invasive interface - i.e., nasal or face mask, nasal cannula, or oral interface.
HCPCS code A7032 is used for a replacement nasal mask interface that goes around the nose, but not into the nostrils. The unit of service for this code is “each”.
HCPCS code A7033 is used for a replacement nasal cannula-type interface. This interface extends a short distance into the nostrils. The unit of service for this code is “pair”. For some products, there are two physically separate cushions or “pillows” – one for each nostril. Two cushions/ pillows equal one unit of service of A7033. For other products, the interface is a single piece with two protrusions that extend into the nostrils. One of these interfaces equals one unit of service of A7033.
HCPCS code A7027 (Combination oral/nasal mask, used with continuous positive airway pressure device, each) is a two-piece system with separate elements for oral and nasal use.
A liner is a soft, flexible material, which is placed between the patient’s skin and the PAP mask interface. Liners used with a PAP mask are made of cloth, silicone or other materials. Liners are not interfaces for use with a PAP mask. Consequently, liners should not be billed as replacement features of a PAP mask such as A7031 (Face mask interface, replacement for full face mask, each) or A7032 (Cushion for use on nasal mask interface, replacement only, each). Liners billed as replacement features of a PAP mask should be coded A9270 (Non-covered item or service).
Monitoring devices (integrated or modular) are capable of tracking data generated by a RAD device, which can be subsequently downloaded for further analysis by a healthcare provider, DME supplier, or beneficiary. Such technologies include, but are not limited to:
- Smart cards and readers
- USB/Thumb drive accessories
- Wired telephonic transmission modules
- Wireless modems
HCPCS code A9279 (MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED) describes any type of monitoring technology. Code A9279 is all-inclusive and is to be used whether the monitoring technology is incorporated as part of a base item, supplied as an add-on module or is a stand-alone item.
Use of multiple instances of A9279 to bill separately for individual monitoring features is incorrect coding.
There is no Medicare benefit or payment to DMEPOS suppliers for remote monitoring services. Suppliers must not bill A9279 for remote monitoring services
Claims billed for monitoring technologies using other NOC codes such as E1399 [DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS] will be denied as incorrect coding.
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 HCPCS codes for individual items are included in the functionality of code E0467:
- HCPCS codes E0470, E0471, E0472, E0561, E0562, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046
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.