Respiratory Assist Devices - Policy Article

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 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, 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. MODIFIERS 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. KX MODIFIER: Suppliers must add the KX modifier to claim lines billed for a respiratory assist device (E0470 or E0471), and related supplies and accessories, only if all of the coverage criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section in the related LCD and/or in the related NCD 240.9 have been met and evidence of such is retained in the supplier’s files and available to the DME MAC upon request. If the requirements for the KX modifier are not met, the KX modifier must not be used. GA AND GZ MODIFIERS: 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. CODING GUIDELINES 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. Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)