Home Sleep Testing Surges
“Prior to the COVID-19 pandemic, adoption of telemedicine by sleep specialists had been slow, due largely to complex, fragmented, and inadequate reimbursement policies for virtual visits,” says Carden, who practices as a sleep specialist at Saint Thomas Medical Partners – Sleep Specialists in Nashville, Tenn. But, according to telemedicine and home sleep testing vendors, it ramped up quickly as government officials required residents to stay home for all except for the most urgent of tasks.
During the months of March and April, Cleveland-based home sleep testing company CleveMed saw a surge in demand for its mail-order service. At that time, its CEO and president Hani Kayyali told
Sleep Review that the company had almost tripled its business. The company’s orders grew by approximately 85% in March alone.
“We have never, ever seen such growth in demand. We are seeing, over the past six weeks now, an unprecedented demand,” Kayyali said at the time. “We are trying to keep up.”
According to Kayyali, most of the calls that CleveMed received this spring were from large medical facilities that already have home sleep testing (HST) available but were looking to bulk up their programs.
Itamar Medical too received new calls from clinicians looking to beef up their home sleep study programs. Itamar Medical’s WatchPAT One home sleep test is fully disposable, making it an attractive option for some during the pandemic. The company also offers a WatchPAT Direct program, which handles the logistics of shipping for the medical practice or lab. The program allows providers to scale home sleep programs quickly with no upfront costs and with minimal effort from office staff, says Phillip Dukes, vice president of clinical sales at Itamar.
Medical device company BioSerenity also saw a large percentage of the medical centers it works with switch over to HSTs, says its CEO Pierre Frouin. “We have seen entire hospital systems switching over,” Frouin says.
Some in the home sleep testing space think this growth is a signal of a permanent pivot toward telehealth solutions.
Vice president of sleep marketing at ResMed, Annie McBride, says many regions experienced a scarcity of beds before the pandemic. Since patients are likely putting off their sleep studies, there could be a backlog of people looking for these diagnostic tests.
The psychological strain of the pandemic could also leave patients unwilling to leave their homes for overnight sleep studies. “It will likely take some time for patients to be psychologically ready to pursue elective sleep lab and hospital visits,” says McBride.
A Bump in Infection Control Questions
Manufacturers report a rise in questions about infection control. Most companies follow the US Centers for Disease Control and Prevention guidelines for disinfection.
Since viruses and bacteria are only viable on surfaces for so long, the three-day turnaround time for CleveMed’s mail-order delivery program means there is less of a chance of transmission than if the devices immediately went back into circulation, says Kayyali.
All reusable components, the monitor, and the pulse oximeter are not in use for three days between patients (and are cleaned and disinfected first). Sensors that come with the test, including the nasal cannula and the respiratory belts, are disposable.
“We have updated our disinfection processes and continue to train our team on that,” says Kayyali.
Payors Expand Telemedicine Coverage
In response to the pandemic, the
Centers for Medicine & Medicaid Services (CMS) loosened coverage guidelines for at-home sleep apnea treatments and devices.
2 Though it is unclear which guidelines will return to pre-pandemic protocols and when, the changes could set new expectations and signal an industry shift in how care is administered. During the pandemic, CMS has given greater flexibility to patients and clinicians by waiving requirements for face-to-face and in-person encounters, such as those required for ongoing positive airway pressure (PAP) therapy.
“This change is going to make it less burdensome for Medicare patients to maintain coverage for PAP therapy,” Carden says.
CMS also responded to COVID-19 by making a temporary policy change to cover PAP devices based on the clinician’s assessment of the patient without requiring an in-lab sleep study or home test.
2
“This change enhances the value of a sleep specialist’s clinical judgment and expertise, and it offers the opportunity for patients with suspected sleep apnea to receive therapy much more quickly,” Carden says. “However, it remains to be seen if this decision will have any unintended negative consequences for the quality of patient care.”
While there are still questions about the future of telemedicine, the demand for these services is skyrocketing. Due to this greater demand, the AASM released its telehealth platform AASM SleepTM to all members for a limited time. It also released its
Sleep Telemedicine Implementation Guide, a 52-page document that is available to download for free on the AASM’s website, which covers how to start a telemedicine program.
3
“Given the increasing demand for treatment of sleep-related disorders, the AASM leadership thinks that telemedicine is one of the mechanisms to address workforce challenges,” the guide says.
“Telemedicine utilization for sleep medicine is likely to expand rapidly, as are broader telehealth applications in general; further research into the effect and outcomes of these applications is needed.”
How to Start Remote Programs
Now, a number of sleep medicine providers are looking to scale up their home sleep testing programs and some are even beginning to look at starting programs from scratch. The AASM suggests that providers first should ask themselves if telemedicine is right for their practice.
The next step is to identify the target audience and then decide whether to invest in a mail-order home sleep testing program or to buy the equipment outright. An advantage to mail-order services is the patient never has to travel anywhere, and the home sleep tests can be mailed directly to their residence, explains Kayyali.
Another important step is to investigate the regulatory, legal, and ethical considerations of the implementation of telemedicine.
Data security is of utmost importance when evaluating equipment and software. When looking for software, providers should consider asking vendors questions about how the data is stored and transmitted. Is the patients’ information transmitted and stored in a way that is Health Insurance Portability and Accountability Act (HIPAA)-compliant? Are both live and stored information encrypted?
The upfront capital expenses will be another factor in determining if telemedicine is the right direction. For home sleep testing only, there may be minimal to no startup costs for a mail-order program, which may charge under a per-study contract. But for new patient and follow-up live telemedicine visits, a substantial investment in equipment may be required. Although some telemedicine companies offer comprehensive plans for equipment purchase and maintenance, others provide à la carte purchasing options.
Key start-up components may include a webcam for the provider site and the patient’s site and software for video transmission that is both HIPAA-compliant and encrypted. Depending on the particular setup, providers may want to invest in a telestethoscope and mobile examination camera. A telemedicine console, or cart, that combines these tools may be convenient, but expenses vary. According to the AASM, consoles range from about $2,000 to more than $20,000 depending on the vendor, brand, and features.
Another option is equipment rentals, which may be available depending on the location and vendor.
Sleep Testing Evolves
More than a decade ago, awareness of sleep apnea home testing started to emerge. As the tests gained popularity with some dentists, cardiologists, and others, the AASM took note. Pressure mounted and the organization released guidance on the use of home sleep testing devices in a 2007 paper, published in the
Journal of Clinical Sleep Medicine.4
The paper, a result of an AASM task force investigation, suggested that unattended portable monitoring for the diagnosis of obstructive sleep apnea (OSA) should be performed only in conjunction with a comprehensive sleep evaluation. It said that portable monitors can be used as an alternative to polysomnography (PSG) for the diagnosis of OSA in patients with a high pretest probability of moderate to severe OSA but is not appropriate for patients with significant comorbid medical conditions.
“That led us down the path of including home sleep apnea testing reluctantly,” says neurologist Jeffrey Durmer, MD, PhD, chief medical officer at Nox Health.
“Now, with coronavirus we are in a different place with home sleep apnea testing. First of all, it is well understood. It has some well thought out criteria developed around it,” says Durmer, who is a principal investigator on the National Institutes of Health-funded
Sleep SMART trial.
Nox Medical has moved to expand the capabilities of home sleep testing by introducing the Nox A1 device, which is a PSG system with both in-lab and at-home functionality. The device, which can perform Level I, Level II, and Level III sleep studies, was first released in 2014 in Europe and debuted in the United States and Canada in March of this year.
“We will be able to get more real-life data associated with their natural sleeping environment but also to bring sleep testing into the home,” says Durmer. “This way, people are not being pulled into a laboratory, which has high costs associated with it. So developing the Nox A1, which is the big brother of the Nox T3, to do home sleep testing, not just sleep apnea testing, that now is part of our program.
“There is now more acceptance of home-based sleep testing. There are people wearing wearables to track their sleep at home. I think it is a perfect time now to invest in a post-coronavirus telemedicine environment.”
Lisa Spear is the associate editor of Sleep Review
.
References
1. Roy S. How is the coronavirus impacting sleep medicine professionals?
Sleep Review. 2020 Apr;21(4):12-5.
2. Singh J, Badr MS, Epstein L, et al. Sleep telemedicine implementation guide. American Academy of Sleep Medicine. 2017. Available at
www.aasm.org, Clinical Resources, Telemedicine (
https://j2vjt3dnbra3ps7ll1clb4q2-wpengine.netdna-ssl.com/wp-content/uploads/2018/06/SleepTelemedicineImplementationGuide.pdf).
3. Physicians and other clinicians: CMS flexibilities to fight COVID-19. Centers for Medicaid & Medicare Services. 29 Apr 2020. Available at
https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.
4. Collop NA, Anderson WM, Boehlecke B, et al. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine.
J Clin Sleep Med. 2007 Dec 15;3(7):737-47.
Post a Comment