Centers for Medicare and Medicaid Services Positive Airway Pressure Adherence Criteria May Limit Treatment to Many Medicare Beneficiaries

Abstract

Study objectives: Centers for Medicare and Medicaid Services (CMS) reimbursement for positive airway pressure (PAP) devices for obstructive sleep apnea treatment is dependent on patients meeting adherence expectations within the first 3 months on therapy. Adherence is defined as usage of the device for at least 4 hours per night on 70% of nights during a consecutive 30-day period. We hypothesize that the adherence pattern may be established beyond this initial period, which may limit the opportunity to treat many patients.

Methods: Treatment and adherence data from PAP devices were monitored via wireless modems for 42 consecutive PAP-naïve military veterans who completed 1 year of nightly monitoring. Their baseline characteristics were as follows: age (mean ± standard deviation) 58.5 ± 12.5 years; body mass index 33.7 ± 5.7 kg/m2; diagnostic apnea-hypopnea index (pretreatment) 28.1 ± 18.5 events/h; apnea-hypopnea index on PAP: 4.3 ± 3.3 events/h. We examined daily, monthly, quarterly, semiannual, and annual reports, and the best 30-day adherence report for each quarter.

Results: In the first 3 months, 19 of 42 participants were adherent by CMS criteria, and 23 of 42 participants were not. Of the 19 adherent participants, 13 remained adherent and 6 became nonadherent or stopped PAP treatment for the remainder of the year. In the 23 initially nonadherent participants, 16 stopped PAP treatment, and 7 participants (30.4%) became adherent (using CMS criteria) during the rest of the year. Thus, PAP adherence during the first 3 months was predictive for the rest of the year in only 68.4%. PAP nonadherence during the first 3 months was predictive for further nonadherence in only 69.6% of the cases. Overall, this led to a 65% sensitivity and 72% specificity of using adherence at 3 months in predicting adherence at 1 year.

Conclusions: CMS adherence criteria affecting PAP coverage are restrictive and can result in the withholding of therapy in many patients who otherwise might become adherent.

Clinical trial registration: Registry: ClinicalTrials.gov, Title: Remote Monitoring in Obstructive Sleep Apnea, Identifier: NCT01678560, URL: https:// clinicaltrials.gov/ct2/show/NCT01678560.

Keywords: Centers for Medicare and Medicaid Services; PAP adherence; obstructive sleep apnea.

© 2019 American Academy of Sleep Medicine.

Figures

Figure 1. Study flowchart, and baseline characteristics of the study population.

* = results are reported in mean and standard deviation. AHI = apneahypopnea index, BMI = body mass index, PI = principal investigator.

Figure 2. PAP adherence at 3 and at 12 months using the Centers for Medicare and Medicaid Services definition of adherence.

PAP = positive airway pressure.

Figure 3. Positive airway pressure usage of patients with AHI greater than 20 and AHI less than 20.

AHI = apnea-hypopnea index.

Figure 4. Usage patterns.

Usage patterns of an adherent patient (A) by Centers for Medicare and Medicaid Services criteria demonstrating fewer hours of total usage than a nonadherent patient (B). The green bars indicate nights of greater than 4 hours of use. The red bars indicate nights when positive airway pressure use was less than 4 hours.

Figure 5. Adherent from the start.

Patterns of PAP use for an entire year for 6 patients who were adherent at 3 months using CMS criteria. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. CMS = Centers for Medicare and Medicaid Services, PAP = positive airway pressure.

Figure 6. Predominant and periodic adherence.

Patterns of PAP use for an entire year for six patients with predominant and periodic PAP adherence through the entire year. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. PAP = positive airway pressure.

Figure 7. Fading adherence.

Patterns of PAP use for an entire year for 6 patients whose adherence faded with time and was nonexistent by the end of the year. Some were adherent at 3 months. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. PAP = positive airway pressure.

Figure 8. PAP learners.

Patterns of PAP use for an entire year for 7 patients whose PAP use improved as the year progressed. None met CMS criteria at 3 months. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. CMS = Centers for Medicare and Medicaid Services, PAP = positive airway pressure.

Figure 9. Nonadherent patients.

Patterns of PAP use for an entire year for 3 subadherent patients becoming nonadherent. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. PAP = positive airway pressure.

Figure 10. Consistently nonadherent.

A pattern of immediate nonadherence. Patterns of PAP use for an entire year for 6 patients who may have made some early attempts but very quickly disengaged. The green lines indicate nights of greater than 4 hours of use. The red lines indicate nights when PAP use was less than 4 hours. PAP = positive airway pressure.