WELLNESS
01/11/2016 12:05 pm ET Updated Jan 11, 2017

Medicare Regulations Are Driving a Wedge Between Obstructive Sleep Apnea Patients and Their Providers

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By Gerard Meskill, M.D.

With over 52 million enrolled beneficiaries, Medicare's policies and practices influence a large percentage of America's healthcare population (1). With some studies estimating that as many as 20 percent of the American adult population (with higher numbers in the older population) suffer from Obstructive Sleep Apnea (OSA), this means that Medicare's policies affect many with this condition (2). As of July 1, 2013, Medicare has the strictest policies of any insurer on the administration and maintenance of continuous positive airway pressure (CPAP) devices and supplies for the treatment of OSA. On the surface, the rationale for some of these policies may seem logical. However, the unbending enforcement of these Medicare rules regarding durable medical equipment (DME) has led to unintended consequences, including the repossession of CPAP machines from patients, extended delays in administration of equipment related to OSA, denial of continuation of treatment for patients who have been using CPAP for years, and damaged relationships between patients and healthcare providers.

In order to understand the problem, we must first discuss what these Medicare policies are, and the rationale behind them. In order for a patient to qualify for treatment of OSA, the patient must have a face-to-face encounter with a physician who documents a concern for OSA and refers the patient for a sleep study. That sleep study must demonstrate the presence of OSA based upon Medicare's definition for the condition, which differs from the current American Academy of Sleep Medicine (AASM) definition (more on that later). Then if the patient gets a CPAP device, the device's data must be tracked to show compliance. If compliance is not demonstrated within 90 days, then the device must be returned, and if the patient wants to try again, the process must be repeated.

The rationale behind this policy lies in an ugly fact: almost 50 percent of patients who are prescribed a CPAP device will quit within one year (3, 4). The majority of those who quit will do so quickly. By repossessing devices that aren't used, Medicare is saving money on devices, and those savings are passed on to the taxpayer who contributes to the system. To further increase savings, Medicare conducted a competitive bid among DME providers and only awarded contracts to certain venders who can provide service cheaply.

Unfortunately, this practice is not working out as planned. The bottleneck created by limiting who can dispense DME equipment for patients has led to delays in initiation of care. When errors in proper equipment disbursement occur, there are also delays in switching to the proper equipment and settings. Patients with improper equipment are likely to be intolerant to therapy, which then causes them to fail to meet Medicare compliance rules. To make matters worse, sometimes the DME provider will blame the physician or office staff for the error. Not knowing who to believe, the patient ends up furious at everyone involved. I have seen this occur several times with my own patients, and it takes an entire 30-minute office visit to explain the Medicare regulations and what went wrong. No one would argue this is an appropriate or cost-effective way for a physician or a patient to spend an office visit.

One of the reasons the DME providers likely are hesitant to process equipment claims for patients is out of fear of a Medicare audit. Personnel for DME providers have stated that should Medicare find an irregularity in paperwork submitted for a DME claim, Medicare may require a full refund for the equipment rendered. Furthermore, they may then audit more claims from the same DME provider. At best, this cascade of events could create a huge headache for that company. At worst, it may lead to mass refunds to Medicare that put the company out of business.

Here is a recent patient encounter of mine that highlights the problem. The patient had been on CPAP since 2006. Her DME provider looked back into her account and saw that her original sleep study was never signed. They told her she would need the physician to sign the sleep study or else she would be unable to continue to receive her CPAP supplies. Unfortunately, that physician had died. Since he could not sign the study, she was told she had to have a repeat sleep study in order to continue to receive CPAP supplies.

The repeat study met the AASM's definition of OSA, but it did not meet Medicare's. Medicare still uses rules from 2005 that require a person's oxygen level to drop by 4% at least five times per hour for the diagnosis of OSA to be made. As early as 1993, Guilleminault et al. demonstrated this was incorrect (5). The AASM changed their definition for OSA in 2012 to no longer require oxygen desaturation for the diagnosis of OSA, but Medicare never followed suit. The rationale for maintaining the older definition is that the Sleep Heart Health Study demonstrated that long-term cardiovascular risk from OSA is linked to oxygen desaturation (6). However, people whose OSA doesn't meet the 2005 definition still have symptoms that impact their quality of life (7). After all, we routinely treat conditions like nasal allergies, eczema, and joint pain, even though these conditions do not increase the risk of cardiovascular disease.

When my patient returned to the office, I had to tell her that according to the AASM she had OSA, but according to Medicare, she didn't. She had two options: pay for her equipment out of pocket for the rest of her life, or have another sleep study. Angrily, she chose the latter, and this repeat study met the Medicare definition for OSA. Once again, she was able to get supplies through Medicare, but only after two unnecessary and costly tests were performed.

This happens far too often where patients are required unnecessarily to repeat sleep studies to meet Medicare's draconian guidelines. The irony is that this is being done in the spirit of saving money. Not only is it hurting patient care, but there's no possible way that repeating a sleep study (which costs about as much as a CPAP machine) saves Medicare money. The way things are now, CPAP supplies through Medicare are more tightly regulated than OxyContin prescriptions are. People who need CPAP supplies are not drug addicts, and they don't deserve to be treated as such.

I have a solution based on a simple premise: people who benefit from CPAP therapy are going to do whatever is necessary to keep it, and people who are not interested in using CPAP therapy will not require much enticing to return their devices. I recommend Medicare continue to track compliance for the first 90 days, just as they have been doing. If compliance is not met in 90 days, then the patient can be given the option to either return the device or take the responsibility of continuing the monthly payments for the PAP device. (Medicare pays the DME provider monthly for 13 months until the PAP device is paid in full.) Once they become compliant, Medicare resumes covering the monthly payments. Those who are unwilling to use the device will return it rather than pay the monthly rate, while those motivated to use PAP now at least will have an avenue to do so that does not require a repeat sleep study.

As a further way of opening avenues to therapy, Medicare also needs to update their definition of OSA to match the 2012 AASM definition. Even if milder OSA does not increase cardiovascular risk (and this is by no means a certainty), it has been shown to increase the risk of depression, insomnia, and overall poorer quality of life. Are these complications also not worth avoiding? Do they not also cause harm to patients and cost the healthcare system?

There are many Medicare patients with OSA. The current guidelines for administering CPAP and CPAP supplies are hindering care by causing delays, denying care for some affected individuals, and driving a wedge between physicians and their patients. Some relaxation of current guidelines could significantly reduce the barrier of care, leading to benefit for patients and providers, as well as fewer expenses for Medicare. In the interim, if you are a patient having trouble getting CPAP supplies through Medicare, I would encourage you to write a letter to your congressional representative.

Sources:

1. The National Committee to Preserve Social Security and Medicare (http://www.ncpssm.org/Medicare/MedicareFastFacts)

2. Somers VK, White DP, Amin R, Abraham WT, Costa F, Culebras A et al. Sleep apnea and cardiovascular disease: an American Heart Association/American College Of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council On Cardiovascular Nursing. In collaboration with the National Heart, Lung, and Blood Institute National Center on Sleep Disorders Research (National Institutes of Health). Circulation 2008; 118: 1080-1111.

3. Norman Wolkove, Marc Baltzan, Hany Kamel, Richard Dabrusin, and Mark Palayew. "Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea." Can Respir J. 2008 Oct; 15(7): 365-369.

4. Terri E. Weaver and Ronald R. Grunstein. "Adherence to Continuous Positive Airway Pressure Therapy." Proc Am Thorac Soc. 2008 Feb 15; 5(2): 173-178.

5. Guilleminault C. et al. "A cause of excessive daytime sleepiness. The upper airway resistance syndrome." Chest. 1993 Sep;104(3):781-7.

6. Redline S. et al. "Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study." Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77.

7. Goncalves MA, Paiva T, Ramos E, Guilleminault C. "Obstructive sleep apnea syndrome, sleepiness, and quality of life." Chest. 2004 Jun;125(6):2091-6.

Gerard Meskill, M.D. is a board-certified neurologist who specializes in the treatment of sleep disorders. He completed his sleep fellowship training at the Stanford Center for Sleep Sciences and Medicine. He now practices sleep disorders medicine and neurology in the Greater Houston area at Comprehensive Sleep Medicine Associates, with offices in the Woodlands, the Houston Medical Center, and Sugar Land, Texas. For more information, visit http://www.houstonsleep.net.