Rule 5160-10-08 | DMEPOS: high-frequency chest wall oscillation (HFCWO) devices.
(1) Payment may be made for a high-frequency chest wall oscillation (HFCWO) device on a rental/purchase basis.
(2) The default certificate of medical necessity (CMN) is form ODM 10229, "Certificate of Medical Necessity: High-Frequency Chest Wall Oscillation Devices" (7/2018).
(3) An initial trial period of at least two months is required. Payment may be made for rental during this trial period, excluding any portion that coincides with an inpatient hospital stay, and a CMN must include the following elements:
(a) Evidence of a respiratory condition for which a HFCWO device is an appropriate treatment, including but not limited to the following examples:
(i) A diagnosis of cystic fibrosis that has not been ameliorated by any other treatment;
(ii) A diagnosis of another respiratory condition that produces chronic, excessive, retained bronchopulmonary secretions; or
(iii) A medical history of chronic or recurrent respiratory infections that require antibiotics and multiple hospitalizations and are unresolved by other bronchial hygiene therapy;
(b) If applicable, documentation that other airway-clearance treatments are ineffective or contraindicated;
(c) Specification of the duration and frequency of therapy; and
(d) If applicable, specification of other individuals (e.g., siblings) with whom equipment is to be shared.
(4) If use of the HFCWO device is to be continued in a residential setting after the initial trial period, the CMN must be revised to include the following information:
(a) An attestation to the effectiveness of the device during the trial period and every previous rental period;
(b) If applicable, specification of a change in the duration or frequency of therapy; and
(c) A recommendation either for additional rental or for purchase.
(B) Constraints and limitations.
(1) The need for a HFCWO device is not established if the condition diagnosed is not accompanied by such symptoms of respiratory distress as the accumulation of bronchopulmonary secretions or bronchopulmonary infection. Common diagnoses that by themselves do not establish need include but are not limited to the following examples:
(a) Amyotrophic lateral sclerosis;
(b) Asthma, uncomplicated;
(c) Bronchiectasis, uncomplicated;
(d) Cerebral palsy, any variety;
(e) Chronic obstructive pulmonary disease (COPD);
(f) Chronic respiratory failure, unspecified;
(g) Muscular dystrophy;
(h) Pneumonia, uncomplicated;
(i) Polyneuropathy; and
(2) Payment for a HFCWO device that has been dispensed on the basis of a diagnosis alone is subject to recovery.