Related Medicare Advantage Medical/Pharmacy Coverage Policies

None

Related Documents

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.

There are no NCD and/or LCDs for Bronchial Thermoplasty.

Description

Bronchial Thermoplasty

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Bronchial thermoplasty (BT) has been suggested as a treatment for severe asthma in individuals 18 years of age or older whose asthma is not well controlled with standard medical therapy (eg, inhaled corticosteroids and long-acting beta-agonists). This treatment was designed to reduce, debulk or partially eliminate excess smooth muscle tissue in the central and peripheral airways to decrease the number of severe asthma attacks.¹³ One example of a US Food & Drug Administration (FDA)-approved bronchial thermoplasty system is the Alair Bronchial Thermoplasty System.

During the outpatient procedure, a flexible bronchoscope is inserted into the lungs via the individual's mouth or nose. The thermoplasty catheter is then introduced through a channel within the bronchoscope. Once in place, the catheter tip expands, allowing four electrodes to contact the airway wall. Using a radiofrequency controller, the physician delivers controlled thermal energy to heat smooth muscle in the airway wall to approximately 150 degrees Fahrenheit (enough to thin smooth muscle tissue mass without causing tissue damage or scarring). Three sessions are required approximately 3 weeks apart to treat all accessible airways in both lungs, except for the right middle lobe.¹³

Bronchial thermoplasty is not intended to be performed on individuals with asthma who have a known sensitivity to atropine, benzodiazepines, lidocaine or for those with a pacemaker, implantable cardioverter defibrillator or other implantable electronic devices.²¹

Coverage Determination

Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

Bronchial thermoplasty (BT) will not be considered medically reasonable and necessary. A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.

Summary of Evidence

Several studies showed an inconsistent benefit across multiple outcomes. A low-quality body of evidence suggests that BT may reduce asthma exacerbations, healthcare utilization and medication usage as well as potentially improving symptom control and asthma-related quality of life in individuals with severe asthma. Improvements in symptom control and quality of life measures following BT relative to baseline values were clinically significant. Pulmonary function measures are not improved with BT. Comparative data were available through 1 year after thermoplasty, while open-label follow-up was available for up to 10 years post BT and showed a sustained benefit compared with baseline. Adverse events were common during the BT treatment period. Further studies should seek to determine which patients with severe asthma are most likely to benefit from treatment and evaluate the relative effectiveness of BT compared with other add-on treatments for severe persistent asthma, including monoclonal antibody therapies.¹⁵

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage