Expert Panel Guidelines Promote Access to In-Home NIV for Patients With COPD

The American College of Chest Physicians (ACCP), the American Association for Respiratory Care (AARC), the American Academy of Sleep Medicine (AASM), and the American Thoracic Society (ATS) have published a joint report with recommendations for solutions to problems regarding US-based insurance coverage policies that create barriers to noninvasive ventilation (NIV) access for appropriate patients with chronic obstructive pulmonary disease (COPD). The recommendations were published in a new edition of Chest.

According to the guideline authors, the prevalence of “onerous diagnostic requirements focused on oxygenation” in Centers for Medicare & Medicaid Services (CMS) policies, coupled with challenges in accessing bilevel devices with backup capabilities, result in some patients with COPD being prescribed home mechanical ventilators rather than more appropriate devices. The guideline committee further explained that several problems exist with current US coverage determination for NIV in COPD management, given these determinations do not always take into account unique complexities of patients’ conditions.

The ACCP/AARC/AASM/ATS COPD Technical Expert Panel working group sought to close gaps in patient access to NIV for COPD management through the development of an evidence-based guideline. This article summarizes those recommendations as well as specific comments related to improving NIV access among the COPD population.

Recommendations on Improving NIV Access

To improve NIV Medicare access promotion and update national coverage determination for bilevel positive airway pressure (BPAP) devices in COPD, the guideline committee recommends removing the need for nocturnal oximetry testing with either 2 L/min nasal oxygen or the patient’s usual FIO₂, whichever is higher. Additionally, the committee recommends removal of the requirement that patients start with a BPAP device without a backup rate.

Instead, the COPD Technical Expert Panel working group recommends the following criteria should be satisfied in patients with severe COPD:

• Arterial blood gas (ABG) while awake and receiving supplemental oxygen (if prescribed) displaying a PaCO₂ ≥52 mm Hg
• Obstructive sleep apnea and continuous positive airway pressure treatment have been considered and ruled out (formal testing not required; this only needs clinical documentation)
• Patients with severe hypercapnic COPD should be considered for a home mechanical ventilator under the following circumstances if they need any of the following:

o   Higher inspiratory pressures than those deliverable by E0471 devices

o   FIO₂ >40% or 5 L/min nasally

o   Ventilator support for ≥10 hours per day (ie, daytime use)

o   Both sophisticated alarms and accompanying internal battery (high-dependency patient)

o   Mouthpiece ventilation during the day

o   Persistence of hypercapnia with PaCO₂ ≥52 mm Hg despite adequate adherence to BPAP therapy

Recommendations on NIV Adherence

The guideline committee wrote that published adherence rates to NIV in COPD vary considerably, citing statistics showing that 30% of patients use the devices less than 4 hours a day and 13% discontinue the treatment altogether within 28 months. Given that adherence is related to patient outcomes, the guideline authors recommend modification of adherence criteria proposed in other Technical Expert Panel reports. Specifically, the guideline recommends an increased duration of time for patients with COPD who are actively engaged in care to meet proposed adherence criteria. This recommendation includes a second 90-day trial period for patients who did not meet initial adherence criteria for continued coverage, but who have returned at least twice to a treating clinician and would experience benefit from continued use of NIV.

Recommendations on Monitoring

In the guideline, the Technical Expert Panel also made several follow-up recommendations for patients with COPD who use NIV in the home. These recommendations included the following elements:

• Clinical assessment by experienced personnel who are familiar with the consequences of COPD and NIV use
• Assessment of ABG PaCO₂ in order to assist patients with ventilator-adjustment and to provide guidance for meeting patients’ evolving needs
• Overnight pulse oximetry to complement to the ABG
• Obtaining a trend report that includes use patterns, synchrony and triggered breaths, respiratory rate and tidal volume, minute volume, and leaks from ventilator software

Additional Comments/Recommendations

Several additional comments and recommendations were discussed by the guideline committee, including those related to:

• Initial NIV setup: The Technical Expert Panel noted that “NIV devices must interact with patient breathing efforts throughout the ventilatory cycle,” stating that a patient must exert sufficient effort to start a breath and must synchronize with the NIV device to ensure adequate pressure and flow delivery. The NIV setup process can be complex, given that patients with COPD tend to have pronounced dyspnea and anxiety. As such, the guideline committee suggests that initial NIV setup could be accomplished in short outpatient clinic visits in complex cases. Additionally, the committee advocates for skilled clinicians, such as respiratory therapists, to pay frequent visits to patients’ homes and make adjustments to devices to ensure successful setup.
• Ongoing NIV use: The guideline panel explained that NIV support should optimally be dynamic and capable of adapting to patient conditions and other medical interventions over time. Additionally, the guideline panel noted that resetting devices as changes occur is best accomplished via home face-to-face visits in which both the ventilator and patient can be observed directly.
• The need for respiratory therapists: According to the Technical Expert Panel, there is a need for experienced clinicians to provide support for patients with COPD on NIV, as this could help in avoidance of risk, regardless of whether the patient is on BPAP or home mechanical ventilator. “We would strongly urge CMS to work with the medical community to find ways to provide this essential element of care for Medicare beneficiaries in the home who are ventilated,” the panel wrote.

Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.

Reference

Hill NS, Criner GJ, Branson RD, et al. Optimal NIV Medicare access promotion: patients with COPD: A technical expert panel report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021;160(5):e389-e397. doi:10.1016/j.chest.2021.06.082