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Medical Policy

Policy Num:      01.001.009
Policy Name:     
Policy ID:          [01.001.009][Ac/ B/ M+ P+ ][1.01.21]

Last Review:       September 9,2020
Next Review:       September 9,2021 
Issue:                   9:2020

Related Policies:

ARCHIVED

Mechanical Insufflation-Exsufflation as an Expiratory Muscle Aid

Summary

The published data suggest that MI-E can improve the intermediate outcome of peak cough expiratory flow. Data regarding its role in the clinical management of the patient consist of case series. In some studies, patients have served as their own control, with a decreased incidence of hospitalization among patients who switch from tracheostomy to a noninvasive approach, which may include MI-E as one component. While controlled trials would ideally further delineate who is most likely to benefit from MI-E, particularly those who would benefit from having such a device in the home, such trials are logistically difficult. The heterogeneous nature of the patients, even among those with similar diseases, almost mandates a case by case approach for these patients. For example, the clinical utility of MI-E would not only depend on the physiologic parameters of lung function, but also on the tempo of the disease course, the availability of home caregivers, and patient preference and motivation. The non-investigational status for the MI-E device is based on these considerations. 2004 Update A search of the literature for the period of 2003 through July 2004 did not identify any published articles that would prompt reconsideration of the policy statement. Therefore, the policy statement is unchanged.

Objective

To revise most recent position of BCBS since 2010. Archived policies are inactive. Since archived policies are not updated, Plans should not use them as the sole source of information when reviewing requests for coverage unless the Plan determines that there is no new evidence that effects the conclusions of the archived policy. FEP may provide specific administrative guidance regarding the use of archived policies.

Policy

Mechanical insufflation-exsufflation (MI-E) may be considered medically necessary in patients with neuromuscular disease or spinal cord injury and impaired ability to cough and who require ventilatory assistance.

Policy Guidelines

MI-E may either be offered on a temporary basis in patients with noninvasive intermittent positive pressure ventilation (IPPV) who are suffering from a respiratory tract illness, or may be used on a more chronic basis in an attempt to avoid the option of tracheostomy and suctioning. In patients with a tracheostomy, MI-E may be offered in lieu of suctioning. In general, an impaired ability to cough has been defined as a peak cough expiratory flow of less than 2– 3L per second. The presence of chronic obstructive pulmonary disease, bullous emphysema, known susceptibility to pneumothorax or pneumo-medisatinum, or exposure to recent barotrauma is considered relative contraindications to MI-E.

Benefit Application

BlueCard/National Account Issues A case management approach may be appropriate for patients requiring ventilatory assistance. As noted in the Coding Section, a mechanical insufflation-exsufflation device may be coded for by using the HCPCS code E0482. Medicare classifies this code under the Capped Rental payment category. Capped rental items are typically required to be rented for a period of time before the patient is given the option to purchase the equipment. Payment for items in this category may not exceed a period of continuous use longer than 15 months. After this period, the homecare provider must continue to provide the item without charge until the medical necessity ends or Medicare coverage ends.

Background

^, Normal clearance of airways rests on 3 basic components: a patent airway, mucociliary clearance, and an adequate cough. Patients with spinal cord injuries or a variety of neuromuscular diseases or chest wall deformities may have impaired cough responses, which may lead to respiratory failure during respiratory tract infections due to the inability to clear the profuse respiratory secretions. Chest wall deformities may include kyphosis, scoliosis, or lordosis, while neuromuscular diseases include muscular dystrophy, poliomyelitis, spinal muscle atrophy, myasthenia gravis, amyotrophic lateral sclerosis, or cerebral palsy. The great majority of neuromuscular disease morbidity and mortality is related to respiratory muscle weakness, and the vast majority of episodes of respiratory failure occur during otherwise benign episodes of respiratory tract infections. Chest infections may result in repeated episodes of pneumonia, repeated hospitalizations, and, finally, in tracheostomy with mechanical ventilation. The normal cough consists of 4 stages: 1. a precough inspiration to about 85% of total lung capacity; 2. followed by closure of the glottis; 3. development of thoracoabdominal pressure sufficient to generate an explosive decompression of the chest at glottic opening; and 4. opening of the glottis with exsufflation.

The peak cough expiratory force typically exceeds 5L/sec, with total expiratory volume of about 2.3L. A variety of techniques have been developed to enhance each of these stages. For example, manually assisted coughing is designed to enhance exsufflation and consists of abdominal pressure delivered by a caregiver timed with the glottic opening. Manual assisted coughing may be offered to patients with a peak cough expiratory flow of less than 5L/sec, but is less effective in the presence of scoliosis or obesity or after meals. Glossopharyngeal breathing is a technique to increase inspiratory flow and is commonly used in patients with a decreased vital capacity due to inspiratory muscle paralysis. This breathing technique involves the use of the tongue and pharyngeal muscles to add to an inspiratory effort by projecting (gulping) boluses of air past the glottis. Mechanical insufflation-exsufflation is designed to deliver alternative cycles of positive and negative pressure. The positive pressure causes air to enter the lungs, followed by a rapid drop in pressure that causes exsufflation. One such device, the CofFlator was first marketed during the1950s but fell into disuse with the popularity of tracheostomy and suctioning as a technique of ventilatory support. Subsequently, the concept for the device was reactivated and the device redesigned, resulting in 1993 U.S. Food and Drug Administration (FDA) approval of the In-Exsufflator. (JH Emerson Co, Cambridge, Mass.). The device, which may also be referred to as a "coughalator," is designed to deliver insufflation-to-exsufflation pressure of about +40 to –40 cm H20, which in turn simulates a powerful cough by creating an expiratory flow of 10L/sec. Cycling between insufflation and exsufflation can either be performed manually or automatically. Five or more treatments are generally given in 1 session until no further secretions are expelled, and hemoglobin desaturations related to mucous plugging are resolved. Mechanical in-exsufflation (MI-E) has been used in a variety of patient populations as an adjunct to noninvasive ventilation using intermittent positive pulmonary ventilation (IPPV).

For example, many patients with neuromuscular disease or chest wall deformities with progressive ventilatory failure will use noninvasive IPPV (delivered nasally or orally) either nocturnally or throughout the day, depending on such parameters as vital capacity and oxygenation levels. However, the limitation of IPPV is management of respiratory secretions, particularly during respiratory tract infections or after anesthesia. MI-E thus complements the IPPV by promoting airway clearance. Patients managed at home with noninvasive IPPV may monitor oxygen desaturation levels. A sudden decrease in oxygen desaturation, may prompt the use of MI-E to eliminate the offending mucus plug. Advocates of MI-E state that even patients requiring 24 hours IPPV can be managed noninvasively for prolonged periods of time without hospitalization using this technique. Other patients may initiate IPPV at the time of sudden ventilatory failure, often secondary to a respiratory tract infection or anesthesia; in this setting, IPPV in conjunction with MI-E may eliminate the need for intubation. Depending on the underlying disease, some patients who are intubated with tracheostomies may be able to transition to noninvasive IPPV with closure of the tracheostomy. Intubated patients with tracheostomies typically undergo suctioning for airway clearance.

However, the reach of suctioning is limited to the proximal airways, and the left main bronchus is often missed due to its sharper angle. Furthermore, suctioning may be inadequate to mobilize more tenacious secretions. Therefore, in patients with tracheostomies, MI-E has been used as an alternative or complement to suctioning. In addition, it is suggested that MI-E is more comfortable to the patient than suctioning

Regulatory Status

Rationale

A variety of outcomes can be considered for MI-E. Intermediate outcomes focus on various pulmonary parameters, such as forced cough expiratory volume (FCEP), vital capacity (VC), or oxygen saturation levels. These parameters may be assessed immediately before and after MI-E. Longer term patientoriented outcomes include the incidence of pneumonia, hospitalizations, or need for tracheostomy. Finally, quality of life or patient preference may be an important issue when MI-E is used in lieu of suctioning in patients with tracheostomies. A search of the literature for the period of 1990 through December 2002 did not identify any controlled studies of MI-E, focusing either on intermediate or final health outcomes. The bulk of the literature consisted of case series describing heterogeneous groups of patients. The majority of the literature was authored by one author, JR Bach. With these limitations in mind, the following outcomes have been reported. Intermediate Outcomes In a group of 21 patients treated with noninvasive IPPV, Bach compared the peak cough expiratory flow (PCEF) rate recorded with unassisted coughing, manually assisted coughing, and MI-E. (1) Patients included those with post-poliomyelitis, muscular dystrophy, spinal cord injury, myopathies, and spinal cord atrophy. The patients had been maintained on IPPV for a mean of 17 years for a mean time of 21 hours per day and used MI-E during periods of productive airway secretion. The PCEF rose from 1.81 L/sec following unassisted respiration to 4.27 L/sec following manually assisted coughing to 7.47 L/sec following MI-E. Other review articles, including studies published in the 1950s, also report improvement in the intermediate outcome of peak cough expiratory flow. (2) Final Health Outcomes Tzeng and Bach reported the results of a home protocol for the prevention of pulmonary morbidity in patients with neuromuscular disease, evaluated using a retrospective cohort study. (3) A total of 94 patients were enrolled and were categorized into group I, including those who had more than 1 episode of respiratory failure prior to entering the protocol (n=47) , and group II, including those who were newly recruited if their peak cough flow was less than 270L/min. (n=50). Group I patients were further categorized according to whether they had experienced a "preprotocol period," defined as 2 or more episodes of respiratory failure. In this group, the incidence of hospitalization could be compared before and after institution of the home protocol. The remainder of the group I patients had access to the protocol immediately after the first episode of respiratory failure. The treatment protocol consisted of using noninvasive IPPV continuously or as needed to maintain eucapnia and normal oxygen saturations and MI-E as needed to promptly reverse any decrease in oxygen desaturation. The outcomes consisted of the number of hospitalizations and days hospitalized. Outcomes were reported for a variety of patient subsets, i.e., during the preprotocol period compared to the postprotocol period and subdivided further into those requiring ongoing part-time and full-time ventilatory assistance. For all comparisons, there was a significant decrease in the incidence of hospitalizations and the days of hospitalization. As noted by the authors, this protocol requires the presence of a dedicated and effective caregiver who could provide assistance with coughing, even up to every 5 to 10 minutes, essentially around the clock. Earlier studies from the same institution focusing on patients with muscular dystrophy or spinal muscular atrophy reported similar findings; however, it is likely that these studies had patients overlapping with the 2000 study reviewed above. (4) MI-E has also been incorporated into protocols for the noninvasive management of patients with spinal muscular atrophy. (5-7) While these studies are all uncontrolled, they suggest that, with patients serving as their own control, noninvasive IPPV with adjunctive MI-E may be associated with a decreased incidence of hospitalization. Other studies have focused on patient preference issues. Bach administered a questionnaire to 168 patients with neuromuscular disease who had received ventilatory support with both tracheostomy and noninvasive methods. (8) The respondents were categorized into 2 groups: group 1 consisted of 111 patients who had switched from noninvasive aids to tracheostomy and group 2 included 59 patients who had switched from tracheostomy to noninvasive aids. In group 1, about 50% of the patients and caregivers preferred noninvasive support compared to tracheostomy, while in group 2 almost 100% preferred noninvasive support. The reason for switching from tracheostomy to noninvasive support was not detailed. It is likely that some patients switched due to complications of the tracheostomy, thus potentially biasing the results. It should also be noted that MI-E was not a standard component of noninvasive management. Only 8 patients had access to MI-E; among these patients none preferred tracheostomy to noninvasive support. Garstang and colleagues administered a questionnaire to 18 patients with spinal cord injuries whose management of airway secretions had included both suctioning and MI-E through a tracheostomy tube. (9) Patients received suctioning in the acute care hospital, but transitioned to MI-E once they were transferred to a rehabilitation institute. Patients reported that MI-E was less irritating, painful, tiring, and uncomfortable. However, it should be noted that the questionnaire was administered in the rehabilitation setting, and thus the questionnaire was administered after suctioning had been discontinued for an average time of 242 days. Related Information In 1999, the American Academy of Neurology issued practice parameters for the care of the patient with amyotrophic lateral sclerosis (ALS). (10) These parameters indicated that MI-E could be considered an option in ALS patients as a technique to clear secretions, especially during acute infection. In these parameters, an "option" is defined as a strategy for patient management "for which evidence (class III) is inconclusive or when there is conflicting evidence or opinion." Class III evidence is defined as "evidence provided by expert opinion, case series, case reports and studies with historical controls." In 1998, the American College of Chest Physicians published a report of a consensus conference entitled "Mechanical Ventilation Beyond the Intensive Care Unit." (11) This report included the following recommendation: "Manually assisted coughing is recommended for patients with weakened expiratory muscle who have excessive secretions. Techniques such as mechanical insufflation-exsufflation and mechanical oscillation may be beneficial in certain situations, but further study is required." There is no national Medicare policy regarding MI-E. HCPCS code E0482 is listed as covered by "carrier discretion." The Centers for Medicare and Medicaid Services (CMS) has assigned to the Durable Medical Equipment Regional Carriers (DMERC) the task of developing local medical review policies (LMRP) for MI-E devices. As of September 2002, a draft of this LMRP was made available for comment. (12). The draft policy suggests the following criteria for coverage eligibility for MI-E "Mechanical in-exsufflation devices are covered for patients with a neuromuscular disease that is causing a significant impairment of chest wall or diaphragmatic movement and for whom standard treatments (e.g., chest percussion and postural drainage, etc.) have not been successful in adequately mobilizing retained secretions."

Population Reference No. 1 Policy Statement

For individuals with muscular dystrophy or spinal muscular atrophy

Supplemental Information

Practice Guidelines and Position Statements

Related Information In 1999, the American Academy of Neurology issued practice parameters for the care of the patient with amyotrophic lateral sclerosis (ALS). (10) These parameters indicated that MI-E could be considered an option in ALS patients as a technique to clear secretions, especially during acute infection. In these parameters, an "option" is defined as a strategy for patient management "for which evidence (class III) is inconclusive or when there is conflicting evidence or opinion." Class III evidence is defined as "evidence provided by expert opinion, case series, case reports and studies with historical controls."

In 1998, the American College of Chest Physicians published a report of a consensus conference entitled "Mechanical Ventilation Beyond the Intensive Care Unit." (11) This report included the following recommendation: "Manually assisted coughing is recommended for patients with weakened expiratory muscle who have excessive secretions. Techniques such as mechanical insufflation-exsufflation and mechanical oscillation may be beneficial in certain situations, but further study is required."

Medicare National Coverage

There is no national Medicare policy regarding MI-E. HCPCS code E0482 is listed as covered by "carrier discretion." The Centers for Medicare and Medicaid Services (CMS) has assigned to the Durable Medical Equipment Regional Carriers (DMERC) the task of developing local medical review policies (LMRP) for MI-E devices. As of September 2002, a draft of this LMRP was made available for comment. (12). The draft policy suggests the following criteria for coverage eligibility for MI-E. "Mechanical in-exsufflation devices are covered for patients with a neuromuscular disease that is causing a significant impairment of chest wall or diaphragmatic movement and for whom standard treatments (e.g., chest percussion and postural drainage, etc.) have not been successful in adequately mobilizing retained secretions."

References

1. Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest 1993; 104(5):1553-62. 2. Bach HR. Update and perspective on noninvasive respiratory muscle aids. Part 2: The expiratory aids. Chest 1994; 105(5):1538-44.

3. Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest 2000; 118(5):1390-6.

4. Bach JR, Isikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest 1997; 112(4):1024-8.

5. Bach JR, Niranjan V, Weaver B. Spinal muscular atrophy type I: a noninvasive respiratory management approach. Chest 2000;117(4):1100-5.

6. Bach JR, Baird JS, Plosky D, et al. Spinal muscular atrophy type 1: management and outcomes. Pediatric Pulmonol 2002; 34(1):16-22.

7. Bach JR, Wang TG. Noninvasive long-term ventilatory support for individuals with spinal muscular atrophy and functional bulbar musculature. Arch Phys Med Rehab 1995; 76(3):213-7.

8. Bach JR. A comparison of long-term ventilatory support alternatives from the perspective of the patient and care giver. Chest 1993; 104(6):1702-6.

9. Garstang SV, Kirshblum SC, Wood KE. Patient preference for in-exsufflation for secretion management with spinal cord injury. J Spinal Cord Med 2000; 23(2):80-5.

10. Miller RG, Rosenberg JA, Gelinas DF, et al. Practice parameter: the care of the patient with amyotrophic lateral sclerosis (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology: ALS Practice Parameters Task Force. Neurology 1999; 52(7):1311-23.

11. Make BJ, Hill NS, Goldberg AI, et al. Mechanical ventilation beyond the intensive care unit. Report of a consensus conference of the American College of Chest Physicians. Chest 1998; 113(5 suppl):289S-344S.

12. www.palmettogba.com/palmetto/LMRPs-DMERC.nsf

Codes

ICD-9 138 Post-polio paralysis

           335.0-335.9 Anterior horn cell diseases including amyotrophic lateral sclerosis and spinal muscle atrophy (code range)

           340 Multiple sclerosis

           344.00-344.9 Quadriplegia (code range) 359.0-359.9 Muscular dystrophies (code range)

HCPCS E0482 Cough stimulating device, alternating positive and negative airway pressure

Applicable Modifiers

As applicable

Policy History