Safe use of donated positive airway pressure devices to increase access to treatment for obstructive sleep apnea: a clinical outreach program

Abstract

Coverage to provide positive airway pressure (PAP) therapy for patients with obstructive sleep apnea (OSA) by the Centers for Medicare and Medicaid Services (CMS) and most private insurers is limited to those patients who meet diagnostic criteria for OSA based on a sleep study. Despite PAP therapy being a covered benefit by most insurers, many patients have high out-of-pocket costs due to copays and deductibles. Also, a subset of patients may be diagnosed per the American Academy of Sleep Medicine (AASM) recommended rule (H3A), while not meeting the diagnosis using the acceptable rule (H4) that their insurer requires. ¹ To help patients such as these, our sleep medicine program envisioned and developed a PAP device donation program for patients with diagnosed or suspected OSA. Through our novel initiative, we were able to safely provide patients with donated and refurbished PAP devices at no cost to them. Here we outline the complexity involved in the provision of PAP therapy for patients with OSA and describe our PAP device donation program.

Citation:

Skiba V, McLellan B. Safe use of donated positive airway pressure devices to increase access to treatment for obstructive sleep apnea: a clinical outreach program. J Clin Sleep Med. 2022;18(5):1455–1457.

INTRODUCTION

Financial coverage for patients who have OSA and need PAP therapy is limited to those who meet the diagnostic criteria based on their sleep study. Although PAP therapy may be a covered benefit, the out-of-pocket costs can often be significant and prohibitive to some patients. There is also a subset of patients who do not meet diagnostic criteria for OSA based on the less stringent scoring rules employed by their insurer. This group of patients may have clinical features of OSA, but not meet diagnostic criteria that their insurer requires, which prevents them from PAP therapy coverage.

THE RULES AND REGULATIONS

According to the CMS, coverage of continuous positive airway pressure (CPAP) therapy is initially limited to a 12-week period for beneficiaries who have been diagnosed with OSA and whose OSA improved because of CPAP therapy during the 12-week period. A positive test result for OSA is only established if one of the following criteria are met: apnea-hypopnea index (AHI; based on an attended polysomnogram) or respiratory event index (based on home sleep apnea testing) greater than or equal to 15 events/h or AHI or respiratory event index greater than or equal to 5 events/h and less than or equal to 14 events/h with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia or documented hypertension, ischemic heart disease, or history of stroke. ^{2, 3}

Medicare and some private insurers only accept the AASM H4 rule for scoring of hypopneas, which requires a 4% or greater oxygen desaturation. The AASM H4 rule is less sensitive than the H3A rule for scoring hypopneas, which require either a 3% or greater desaturation or an arousal. ¹ Published studies have found that up to 17% of individuals meeting a cutoff using the H3A rule would be missed by the H4 rule. ⁴

Continued coverage of a PAP device by CMS requires that the treating practitioner conduct a clinical re-evaluation and document the benefit from PAP therapy. This evaluation includes objective evidence of adherence to therapy, defined as use of at least 4 hours per night on 70% of nights during a consecutive 30-day period. Beneficiaries who do not comply with the initial 12-week trial are eligible to requalify for a PAP device, but they must have a repeat clinical re-evaluation and a repeat sleep test in a facility-based setting. ²

Research is emerging regarding the connection between socioeconomic disparities and sleep health. One systematic review of the literature found that low socioeconomic status may be a risk factor for OSA severity. ^{5, 6} Although the number of uninsured individuals has decreased since the implementation of the Affordable Health Act in 2014, ⁷ those who have insurance may still not be able to afford to use it. In 2016, the average annual deductible for an individual unsubsidized health care plan was over $4,000 for individuals and almost $8,000 for a family. ⁸ The cost of PAP machines varies and may exceed $1,000; supplies, including new masks, often cost over $100. ⁹ Most insurers cover part of the cost of PAP therapy, but the coverage varies and may require individuals to meet their high deductibles and pay substantial copays, especially patients with private plans. Medicare is the federally funded health plan offered to individuals 65 years and older and covers certain disabilities; Medicare part B covers PAP machines, masks, and supplies at 80%, once the patient’s deductible has been satisfied. ⁹ Medicaid is the single largest source of health coverage in the United States, covering children and low-income individuals and families. Every state has its own Medicaid program, and coverage varies from state to state; however, CPAP machines, masks, and supplies are commonly covered.

A PAP DEVICE DONATION PROGRAM

In 2018, our Sleep Disorders and Research Department conceived and developed a PAP device donation program. In this initiative, we gather new and used PAP devices from a variety of sources, and these devices are serviced and sanitized by a local medical equipment company. We then offer these donated machines at no cost to patients who could not otherwise afford PAP therapy.

The PAP devices we acquire are most often donated by patients or family members of patients who no longer need their machine for a variety of reasons, such as changing PAP modalities, they are getting a new machine covered by their insurance, they are no longer using PAP, or they have died. The devices are then processed by a medical equipment company that is affiliated with our hospital system. We have a memorandum of understanding with that company to do this service at no cost to us. The PAP devices are cleaned according to the manufacturer’s recommendations for multipatient use ¹⁰: the exterior is disinfected; water tub, air tubing, and air filter are replaced with new ones. The bag is laundered. Each device is also pressure checked to make sure it is working correctly, data are deleted, and settings are reset to factory defaults. The estimated time a technician spends on each device is 30 minutes, and the estimated cost for supplies is $20. The equipment company does not charge our program for any of their costs; we are not privy to whether they track these charitable costs for tax-deduction purposes. Supplies are donated from various PAP manufacturers, older masks are donated from medical equipment companies, and some supplies are purchased with money donated to our program.

The patients are provided with devices by select health care providers in our clinics on a pro bono basis; we do not charge for these visits. Patients sign a letter of understanding and release of liability. Our program does not require any proof of financial need, but we expect the referring clinician to make a good faith effort to assist us in identifying patients in need. We document in the patient’s medical record the maker of the PAP device and serial number, as well as the mask that is given. This information is essential when needing to contact patients during a recall situation. The patients then follow up with their regular sleep provider for management of their PAP therapy. As a part of the program, we guarantee that we will provide patients with a new mask, hose, and filters at least 2 times during the first year. Some of our patients continue to get supplies after this time frame; some choose to purchase them out of pocket.

In the 2 years since we started the program, we have provided devices to a total of 43 patients; their average age was 54 years (range 35–82) and the average AHI was 29 events/h (range 0.8–114). The majority of these patients (n = 27, 62.8%) could not afford the PAP device because of high copays or deductibles. A total of 14 patients (32.5%) had Medicare and had OSA that was diagnosed per the AASM H3A rule but that did not meet the H4 rule that their insurer required. One patient with severe OSA did not meet insurance compliance criteria set by Medicare, and rather than having her repeat a facility-based polysomnogram, we decided to start her on PAP therapy to see if she could tolerate it. There were 2 patients who could not afford a PAP device through their insurance and who were provided with bilevel PAP therapy for amyotrophic lateral sclerosis.

We had 1 patient, a 38-year-old woman, who had a very strong history suggestive of OSA (snoring, apneas, awaking gasping, complaining of daytime sleepiness despite an Epworth Sleepiness Scale of 7, nonrestorative sleep, fatigue, mood alterations, frequent headaches and migraines, with no craniofacial abnormalities) but whose polysomnogram did not demonstrate OSA (3% AHI 0.8 events/h). Nonetheless, she was started on PAP therapy and self-reported significant benefits on follow-up, with nearly resolved headaches and fatigue and an Epworth Sleepiness Scale that had improved from 7 to 0.

Most of the patients in our program were provided with auto-titrating PAP therapy. However, at the start of the COVID-19 pandemic, we had a substantial reduction in the number of PAP devices being donated, and we subsequently ran out of auto-titrating machines. We elected to continue treating patients in need, and we started 8 patients on CPAP therapy with a single empiric pressure. These patients demonstrated good tolerance and low residual AHI on follow-up. Most recently, because of a Philips Respironics recall in 2021, we had to contact several patients who received a Philips Respironics machine and provide them with another brand of PAP device. We had to dispose of a significant number of older donated machines, further diminishing our supply of available PAP devices.

Out of the 43 patients to whom we provided devices, 28 (65.1%) returned for a follow-up visit and 15 (34.9%) were lost to follow-up. Out of the patients who returned for a follow-up visit, 51.7% were compliant with PAP therapy, and the rest were either nonadherent or their adherence was not documented in the notes.

CONCLUSIONS

PAP therapy remains the gold standard treatment for OSA. While CMS and most private insurers cover this therapy, some patients cannot afford the high out-of-pocket costs. Many other patients have OSA but do not qualify for PAP treatment coverage because their diagnoses were not made with the specific AASM criteria that their insurers required. And occasionally, patients may have very strong clinical features of OSA but have normal polysomnography results, which would preclude them from PAP therapy coverage.

Our institution has a well-established program for collecting PAP devices that are no longer being used; working with a local durable medical equipment company to ensure that the machines are sanitized, safe, and functioning correctly; and donating these machines to be used by patients in need. Recycling and reusing PAP devices is a practical way to put functional PAP devices back into circulation so that they can be used by patients who need them.

There are several challenges to creating and maintaining a program such as our PAP device donation program. A local medical equipment company is necessary for processing and sanitizing the PAP machines. This is time-consuming and costly, and a larger company may be better able to offer this service. We have several health care providers in our clinics who are involved in the program and who volunteer their time to collect used machines, deliver them to a central pickup location, and then set up patients with a donated machine. Maintaining a selection of supplies and masks can also be challenging and time consuming, including collecting them, keeping an updated inventory, and managing space to store them. Most of our masks are older versions that are no longer desired by other sleep labs, supply companies, and manufacturers. Although we have not declined refills of supplies to recipients past the 1-year commitment we guarantee, it is foreseeable that in the future we will not be able to provide ongoing supplies and patients will need to purchase them on their own. The program also requires review and approval from health system leadership and infection control. There is inherent liability in a program such as this, and risk management experts at our institution helped us draft a letter of understanding that patients review and sign. An unexpected challenge was the lower than desired rate of recipient follow-up. It may be that patients do not feel obligated to return for follow-up, as there are no financial incentives (ie, insurance compliance requirements). It is also possible that these patients do not have the transportation, time, or money required for a return visit; the same reasons that do not allow them to get a device from a supply company.

Despite the challenges and time commitment inherent in our program, it is very rewarding to be able to provide patients with donated PAP devices and to see significant improvements in their health, wellness, and overall quality of life. Reusing devices is also more meaningful in today’s medical supply climate, where there is an overall shortage of PAP devices, a world-wide shortage of supplies, and even device recalls by major manufacturers.

Programs such as ours, as well as the PAP Assistance Program from the American Sleep Apnea Association, ¹¹ are avenues for some patients to acquire treatment for their sleep-disordered breathing, regardless of their finances. Unfortunately, these programs can only help a small number of patients. Further studies and program development are needed to determine how many patients with OSA are not able to afford ongoing PAP therapy and how to work with CMS and private insurers to determine coverage pathways that work for these patients.

ABBREVIATIONS

AASM

American Academy of Sleep Medicine

AHI

apnea-hypopnea index

CMS

Centers for Medicare and Medicaid Services

CPAP

continuous positive airway pressure

OSA

obstructive sleep apnea

PAP

positive airway pressure

DISCLOSURE STATEMENT

All authors have seen and approved this manuscript. Work for this study was performed at Henry Ford Health System. The authors report no conflicts of interest.