A portable or stationary home model respiratory suction pump (E0600) is an electric aspirator designed for oropharyngeal and tracheal suction.

A portable or stationary home model gastric suction pump (E2000) is an electric aspirator designed to remove gastrointestinal secretions.

For any item to be covered, 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 statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

Use of a respiratory suction pump (E0600) is covered for patients who have difficulty raising and clearing secretions secondary to:

1. Cancer or surgery of the throat or mouth;
2. Dysfunction of the swallowing muscles;
3. Unconsciousness or obtunded state;
4. Tracheostomy.

Accessories and supplies are covered and are separately payable when they are medically necessary and used with a medically necessary E0600 pump in a covered setting.

Sterile suction catheters (A4624) are medically necessary only for tracheostomy suctioning. No more than three suction catheters per day are covered for medically necessary tracheostomy suctioning. When a suction catheter (A4624) is used in the oropharynx, which is not sterile, the catheter can be reused if properly cleansed and/or disinfected. No more than three catheters (A4624) per week are covered for medically necessary oropharyngeal suctioning.

Billing for quantities of supplies greater than those described in the policy as the usual maximum amounts must be supported by documentation in the patient’s medical record which must be available upon request. In the absence of documentation clearly explaining the medical necessity of the excess quantities, they will be denied as not medically necessary. 

Sterile saline solution (A4216, A4217) is covered when used to clear a suction catheter after tracheostomy suctioning. It is denied as not medically necessary when used for oropharyngeal suctioning.

Services not meeting the medical necessity guidelines will be considered not medically necessary. Effective January 26, 2009, a provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Saline used for tracheal lavage is a non-covered supply.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

When billing procedure code(s) A4605, A4624 for patients with a tracheostomy, diagnosis code V44.0 or V55.0 must be entered on the claim form.

When billing for quantities of supplies greater than those described in the "Indications and Limitations of Coverage" section, there must be adequate, clear documentation in the patient’s medical records corroborating the medical necessity of this amount. Copies of the patient’s medical records that corroborate the order and any additional documentation that pertains to the medical necessity of items and quantities billed must be available upon request.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

A closed system tracheal suction catheter (A4605) is a type of suction catheter that is protected by an outer sheath. It is connected to the ventilator circuit of a patient on mechanical ventilation and left in place. Suctioning is accomplished without disconnection from ventilation.

A tracheal suction catheter (A4624) is a long, flexible catheter.

An oropharyngeal catheter (A4628) is a short, rigid (usually) plastic catheter of durable construction.

Effective September 1, 2009, suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items. https://www.dmepdac.com/

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Manual System Publication 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 280.1