Nebulizers - Policy Article

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”). Nebulizers are covered under the Durable Medical Equipment (DME) 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. A large volume pneumatic nebulizer (E0580) and water or saline (A4217 or A7018) are not separately payable and should not be separately billed when used for beneficiaries with rented home oxygen equipment. If a large volume nebulizer, related compressor/generator, and water or saline are used predominantly to provide room humidification it will be denied as noncovered. A prefilled disposable large volume nebulizer (A7008) is noncovered under the DME benefit because it is a convenience item. An unfilled nebulizer (A7007, A7017, or E0585) filled with water or saline (A4217 or A7018) by the beneficiary/caregiver is an acceptable alternative. Kits and concentrates for use in cleaning respiratory equipment will be denied as noncovered. Aztreonam lysine is an inhalation solution that is indicated for beneficiaries with cystic fibrosis with chronic Pseudomonas aeruginosa infection. Because it has been determined that the nebulizer that is FDA-approved for administration of aztreonam lysine is not sufficiently durable to meet the DME statutory requirements for coverage, claims for that nebulizer, aztreonam lysine inhalation solution and related accessories will be denied as noncovered under the Medicare Part B DME benefit. (The aztreonam lysine inhalation solution and related accessories may be eligible for coverage under a different Medicare benefit (e.g., Medicare Part D)). Amikacin liposome is an inhalation solution that is used to treat adults with refractory Mycobacterium avium complex (MAC) lung disease. Because it has been determined that the nebulizer that is FDA-approved for administration of amikacin liposome is not sufficiently durable to meet the DME statutory requirements for coverage, claims for that nebulizer, amikacin liposome inhalation solution and related accessories will be denied as noncovered under the Medicare Part B DME benefit. (The amikacin liposome inhalation solution and related accessories may be eligible for coverage under a different Medicare benefit (e.g., Medicare Part D)). Drugs that are not administered through DME (e.g. Foradil Aerolizer and metered-dose inhalers (MDI’s)) are not billed to the DME MAC but may be covered under other Medicare benefits (i.e., Medicare Part D). If the supplier chooses to submit a claim for drugs not administered through DME, the drug must be billed using code J3535 (DRUG ADMINISTERED THROUGH A METERED DOSE INHALER) and is non-covered by the DME MACs. Disposable equipment or equipment in which a major component required for their function is disposable do not meet the definition of durable medical equipment and must be billed using code A9270 (noncovered item or service). DISPENSING FEE: An initial dispensing fee (G0333) is payable to a pharmacy for the initial 30-day supply of covered inhalation drug(s) regardless of the number of drugs dispensed, the number of shipments, or the number of pharmacies used by the beneficiary during that time. This initial 30-day dispensing fee is a once in a lifetime fee and only applies to beneficiaries who are using inhalation drugs for the first time as a Medicare beneficiary on or after 01/01/2006. If code G0333 is billed for a 30-day supply of covered inhalation drugs and it is not the initial 30-day supply (i.e., G0333 has already been billed to Medicare for that beneficiary), the claim will be denied as incorrect coding. When code G0333 has been billed once in a beneficiary’s lifetime, subsequent claims for a 30-day dispensing fee must be billed using code Q0513. Medicare will only pay for one of the following for covered inhalation drugs regardless of the number of drugs dispensed, the number of shipments, or the number of pharmacies used by the beneficiary during that time period - an initial dispensing fee (G0333), a 30-day dispensing fee (Q0513), or a 90-day dispensing fee (Q0514). For a refill prescription, payment of a dispensing fee will be allowed no sooner than 10 days before the end of usage for the current 30-day or 90-day period for which a dispensing fee was previously paid. Medicare will not pay for more than 12 months of dispensing fees per beneficiary per 12-month period. If the dispensing fee is billed sooner than the interval specified above, it will be denied as not separately payable. For example, if a 90-day fee (Q0514) is billed on 1/30/06 and is covered and there is a subsequent claim for a 30-day fee (Q0513) on 4/10/06, the dispensing fee on 4/10/06 will be denied as not separately payable. Both a Q0513 and a Q0514 dispensing fee are not covered on the same date of service. If a supplier dispenses a 90-day supply of one drug and a 30-day supply of another drug on the same day, code Q0514 (90-day fee) must be billed. The dispensing fee must be billed on the same claim as the inhalation drug(s). If it is not, it will be denied as incorrect billing. A dispensing fee is not separately billable or payable for saline, whether used as a diluent or for humidification therapy. This does not apply to hypertonic saline (J7131), which is administered as an inhalation drug and not a diluent. Medicare will not pay for a separate fee for the compounding of inhalation drug(s). 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. 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. For coverage of add-on ensifentrine (J7601) therapy to dual long-acting beta-agonist (LABA) and long-acting muscarinic-agonist (LAMA) maintenance therapy or LABA+LAMA and inhaled corticosteroid (ICS) triple maintenance therapy, the treating practitioner must document in the beneficiary’s medical records 1 and either 2 or 3 below: The beneficiary will continue use of dual or triple maintenance therapy; and, The beneficiary has a history of continued COPD exacerbations despite dual or triple maintenance therapy, as indicated by either a. or b. within a 12-month period: a. One or more COPD exacerbation(s) leading to at least one of the following: Hospitalization(s); or Emergency room visit(s); or New prescription(s) for systemic glucocorticoids or antibiotics; or b. A combination of at least three of the following clinical parameters during one COPD exacerbation: Dyspnea level of > 5* on a visual analog scale Respiratory rate > 24 breaths per minute Heart rate > 95 beats per minute Testing oxygen saturation of 3% from baseline (when known) C-reactive protein concentration of > 10 mg/L The beneficiary has a history of persistent COPD-related dyspnea despite dual or triple maintenance therapy, as indicated by one of the following: a. Persistent breathlessness; or b. Exercise limitation *Quantification of dyspnea intensity as measured on a 10-point visual analog scale (VAS) where zero equates to not short of breath at all and 10 is the worst shortness of breath ever experienced. MISCELLANEOUS A diagnosis code describing the condition which necessitates nebulizer therapy must be included on each claim for equipment, accessories, and/or drugs. MODIFIERS JW AND JZ MODIFIERS: Effective for claims with dates of service on or after January 1, 2017, the JW modifier is required when billing for unused and discarded amounts of drugs and biologicals from single-dose containers that are administered by the supplier. Effective for claims with dates of service on or after July 1, 2023, the JZ modifier is required when billing for drugs and biologicals from single-dose containers that are administered by the supplier but have no unused and discarded amounts. Effe