A high frequency chest wall oscillation (HFCWO) device is an airway clearance device consisting of an inflatable vest connected by tubes to a small air-pulse generator.

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.

High frequency chest wall oscillation devices (HFCWO)(E0483) are covered for patients who meet:

A. Criteria 1, 2 or 3, and
B. Criteria 4.

1. There is a diagnosis of cystic fibrosis.
   
   
2. There is a diagnosis of bronchiectasis, which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by:
   
   1. Daily productive cough for at least 6 continuous months; or
   2. Frequent (i.e., more than 2/year) exacerbations requiring antibiotic therapy.
      

   Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the absence of a confirmed diagnosis of bronchiectasis do not meet this criterion.
   
   

3. The patient has one of the following neuromuscular disease diagnoses:
   
   Post-polio
   Acid maltase deficiency
   Anterior horn cell diseases
   Multiple sclerosis
   Quadriplegia
   Hereditary muscular dystrophy
   Myotonic disorders
   Other myopathies
   Paralysis of the diaphragm
   
   
4. There must be well-documented failure of standard treatments to adequately mobilize retained secretions.

If all of the criteria are not met, the claim will be denied as not medically necessary. 

It is not medically necessary for a patient to use both an HFCWO device and a mechanical in-exsufflation device (E0482).

Replacement supplies, A7025 and A7026, used with patient owned equipment, are covered if the patient meets the criteria listed above for the base device, E0483. If these criteria are not met, claims will be denied as not medically necessary. 

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. 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.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made 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. Items submitted with an EY modifier will be denied as not medically necessary.

The diagnosis code that justifies the need for these items must be included on the claim.

KX, GA, AND GZ MODIFIERS:

Suppliers must add a KX modifier to codes for an HFCWO device and accessories only if all of the criteria in the “Indications and Limitations of Coverage” section of this policy have been met.

If all of the criteria in the "Indications and Limitations of Coverage" section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter GA on the claim line if they have obtained a properly executed Pre-Service Denial Notice or GZ if they have not obtained a valid Pre-Service Denial Notice. Services submitted with a GA modifier will be denied as not medically necessary and are billable to the member. Services submitted with a GZ modifier will be denied as not medically necessary and are not billable to the member.

Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.

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.

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.