A4216 Medicare coverage

Local coverage indication

Suction catheters (A4605, A4624, A4628) and sterile water/saline (A4216, A4217) are covered and are separately payable when they are medically necessary and used with a medically necessary E0600 pump. Supplies used with DME that is denied as not reasonable and necessary will also be denied as not reasonable and necessary.

Excerpt from LCD L33612 version 26, effective 01/01/2024. CMS LCD L33612.

Local coverage indication

When a "concentrated form" of an inhalation drug is covered, separate saline solution (A4216 or A4218 [metered dose]) used to dilute it will be separately reimbursed. Saline dispensed for the dilution of concentrated nebulizer drugs must be billed on the same claim as the drug(s) being diluted. If the unit dose form of the drug is dispensed, separate saline solution (A4216 or A4218 [metered dose]), will be denied as not reasonable and necessary. Water or saline in 500 or 1000 ml quantities (A4217 or A7018) are not appropriate for use by beneficiaries to dilute inhalation drugs and will therefore be denied as not reasonable and necessary if used for this purpose. These codes are only reasonable and necessary when used in a large volume nebulizer (A7007, A7017, or E0585). Albuterol, levalbuterol, and metaproterenol are all short-acting bronchodilators with beta-adrenergic stimulatory effect. It is not reasonable and necessary for a beneficiary to use more than one of these at a time. The use of more than one of these drugs at the same time will be denied as not reasonable and necessary. Albuterol, levalbuterol, or metaproterenol is covered if it is used as a rescue/supplemental medication in addition to the long-acting beta-adrenergic agonist drug, formoterol or arformoterol. Formoterol and arformoterol are long-acting bronchodilators with beta-adrenergic stimulatory effect. It is not reasonable and necessary for a beneficiary to use more than one of these at a time. The use of more than one of these drugs at the same time will be denied as not reasonable and necessary.

Excerpt from LCD L33370 version 58, effective 02/01/2026. CMS LCD L33370.

What NCD 200.2 says the item is

A. General Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible. Pharmacologic treatment with bronchodilators is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases. These medications are intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways. Beta adrenergic agonists are a commonly prescribed class of bronchodilator drug. They can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler. Nebulized beta adrenergic agonist with racemic albuterol has been used for many years. More recently, levalbuterol, the (R) enantiomer of racemic albuterol, has been used in some patient populations.

National coverage indication, NCD 200.2

B. Nationally Covered Indications N/A C. Nationally Non-Covered Indications N/A D. Other After examining the available medical evidence, the Centers for Medicare & Medicaid Services determines that no national coverage determination is appropriate at this time. Section 1862(a)(1)(A) of the Social Security Act decisions should be made by local Medicare Administrative Contractors through a local coverage determination process or case-by-case adjudication. See Heckler v. Ringer, 466 U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication.). See also, 68 Fed. Reg. 63692, 63693 (November 7, 2003).

Excerpt from NCD 200.2 version 1. CMS NCD 200.2.

From A52519

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. When billing HCPCS code(s) A4605 and/or A4624 for beneficiaries with a tracheostomy, the diagnosis code indicating tracheostomy status must be entered on the claim form. When billing HCPCS code(s) E0600, A7002 and A7047, the diagnosis code(s) for the condition(s) that justify the need for the item(s) must be entered on the claim form.

CMS source A52519

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426

From A52466

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.

CMS source A52466

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426