The question of whether CMS should pay for home sleep testing is stirring up the sleep community.

 Recently, CMS invited comments on the question of modification of coverage guidelines to allow home sleep testing as an alternative to facility-based testing in the evaluation of OSA.

“How does the diagnostic test performance of an unattended portable multi-channel home testing compare to facility-based polysomnography in the diagnosis of OSA?” Today, my answer to this question would be “Not very well.”

As we know, “portable” or home-based systems have been available for many years. In the early 1990s, many of these units were utilized particularly in underserved areas. At that time, the need for sleep testing services was growing dramatically and our ability to provide timely, quality care was limited. Especially in outlying areas, sleep centers were few and far between, and a 1- to 3-month wait for testing was common—not to mention the wait for interpretation. Many centers were located in hospital-based facilities and were sterile and uninviting, often not the homey, relaxing environment conducive to a restful night’s sleep. Registered polysomnographers were also few in number, and the quality of testing was often limited to the quality of the technologist performing the study.

This need for testing helped grow the portable and home-based equipment market. Much of it was done well in specifically selected applications, but sadly, many of these tests were plagued by poor quality outcomes for a wide variety of reasons.

I work in a large hospital-based accredited center, and my experience with home testing and unattended studies has been limited to retesting because of what home-based studies failed to do. Our center frequently saw these patients only after poor studies—and care—resulted in noncompliance with nasal positive airway pressure (nPAP)or continued symptoms that were not identified from those initial home tests. Consequently, the patients and insurance companies incurred additional expenses, as repeat studies were required to rectify the patients’ continuing complaints. Many of us wondered about the potential of “false negatives,” specifically those patients who were told they did not have OSA and therefore did not pursue more definitive diagnosis. Did they get the care they needed or have they simply fallen through the cracks?

Locally, we had a vendor with a van full of sleep equipment for “home studies.” Nursing students and EEG or respiratory technicians would be hired and given a couple of days of training. That “sleep tech” was then paid a flat fee to go to the patient’s house, hook them up, and sit in their

driveway or living room all night while the recording was made. Other patients would go by the office, have electrodes applied, and return for download the next day. In both cases, equipment and data were retrieved and the results shipped off via mail or the Internet to an office in another state to be read by an unknown scorer, interpreted by a physician who never saw the patient, and presto, diagnosis and treatment plans were made. Some tests went well, but many did not. When CMS stopped paying for home testing and unattended tests, thankfully many of these “trunk”-based testing services disappeared.

One might question why the CMS should consider paying for these tests again. Was this initiative driven by a perceived need for more accessible testing services? If so, look around. Today, access to facility-based testing is at a far greater level with what seems like almost every hospital and clinic country-wide offering some level of sleep testing. Polysomnographers are achieving registry at a very rapid rate—more than 1,000 in the past year, and our growing profession is now recognized as a separate and distinct health care profession.

Challenges Today
I believe that the biggest challenge today is not the patients’ accessibility to testing, but ensuring the quality of sleep testing and its interpretation—regardless of venue. Even in facility-based testing, in a rush for profit, there are unscrupulous physicians and technicians with inadequate training producing poor quality sleep tests and care. Electrode placement is questionable, filters adjusted to make a “pretty study,” and the information sanitized by a computer. If CMS resumes coverage of portable and unattended studies, what measures will be taken to ensure a standard level of recording quality? Do we run the risk of seeing a “sleep computer” and “tech” hook up all the snorers in the practice? Further, what parameters will be monitored and how? Airflow and respiratory effort are certainly critical parameters in our testing, but what devices should we use? Do we use pressure transducers or thermistors, piezo crystal belt, or film? Without definition of exact parameters and the required devices to monitor these parameters, can we assure consistent, accurate diagnosis, and care?

What If?
We forget that apnea is only one of the more than 80 currently recognized sleep disorders. Will the physician take the home study information and look further into the patient’s symptoms?

What if it is OSA? How do we treat the patient? Will home nPAP trials be next? One of the most challenging aspects of care for any technologist is titrating positive airway pressure to an optimum therapeutic level. Will the machine diagnose, define, and treat too? Even with frequent mask changes and a lot of TLC, getting some patients to wear nPAP is a tremendous challenge. Compliance with care is so important, and even with our best efforts, it is often less than 75%. Will it get better without a technologist’s intervention?

We must also consider the legal aspect of these devices. In many states, due to respiratory care licensure laws and legislation, RPSGTs are struggling to continue to provide diagnostics with nPAP. In addition, CMS made the announcement this past November that sleep facilities within Region IV will be required to gain AASM accreditation status (recently adjusted to include JCAHO ambulatory care accreditation) in order to maintain Medicare/Medicaid reimbursement status. How will CMS define home testing with nPAP in relation to: 1) the various state licensure requirements, and 2) accreditation requirements in Region IV?

Could it simply be numbers: more tests, more patients, and lower employee costs? Technicians might hook up several patients a day for unattended studies, send them on their way, and thus generate much more income than the two patients they would study in a facility-based center each night. We must not lose sight of the fact that even in the diagnosis of OSA, we must be very careful to select the right patient for portable testing. Not every 300-pound snorer has OSA nor is every 95-pound woman negative for respiratory events. With sleep testing, we are looking at complex multi-physiological factors each with its own subtleties and specific patterns. We must also never underestimate the value of quality polysomnographic technologists and the role they play in the diagnosis and treatment of patients. In a facility-based test, discussions between technologists and patients often reveal valuable information the patient neglected to convey to the sleep medicine specialist physician. This sharing and communications process encourages and comforts the patient with a positive, physical presence. Often, this information is vital in the accurate diagnosis and successful treatment of our sleep patients.

The Bottom Line
So, let’s get to the bottom line: money. This initiative to get CMS to pay for portable/unattended testing could potentially be seen as a means for HMOs, equipment manufacturers, and the respective shareholders to increase profit from lower testing costs, increased equipment applications, and, ultimately, sales. Certainly the sleep field is growing, but is this where we want to go? Money and managed care drive so much of what we do in health care. Should we allow it to dictate quality in our sleep testing? There are too many questions in need of resolution before CMS approves this format of testing. Simply put, the affirmation of ambulatory testing reimbursement stands to open a Pandora’s box of overprescribing and potential abuse.

Over the past few years, our vendors have developed many new innovations and exciting technologies to allow us to acquire and manipulate data in ways unheard of 10 years ago. Certainly, home/portable sleep testing is a part of that; however, it needs to be recognized that efficacy, in terms of both patient care and cost-containment, can occur only in a well-defined and selected population. For example, the Sleep Center at Spartanburg Regional Medical Center in South Carolina utilizes portable studies for in-hospital patients who are too ill to come into the sleep center. Another potential viable use for home-based units is screening in such applications as the CPAP veteran with recurring symptoms to see if his pressure is sufficient.

We need to recognize all the tools available to us and use them in an appropriate manner. Should CMS consider resuming paying for all unattended or portable studies? I hope not just yet. While the technology exists, the guidelines are not in place. Development of these testing parameters, standardization of protocols, and definition of appropriate applications by the end users, the AASM and APT, must first be in place before we can guarantee the consistency of quality our patients deserve.

Shari Angel Newman, RPSGT, is manager of the Sleep Center at Spartanburg Regional Medical Center, Spartanburg, SC. She is also a member of Sleep Review’s Editorial Advisory Board.