7 Things You Need to Know About Home Sleep Testing Right Now

An open book CMS is not. So, if you're wondering which way the wind will blow when the Centers for Medicare & Medicaid Services (CMS) unleashes its final rule on home sleep testing this month, you're in good company. The proposed rule left a lot to the imagination. Everyone — from industry experts to sleep labs to respiratory providers — is hoping for more clarification. Here are the important issues for respiratory HMEs to watch.

1. What We Know and Don't Know from the Proposed Rule
In December 2007, CMS issued proposed changes to its national coverage determination for CPAP therapy that would grant coverage for unattended home sleep monitoring devices. The decision memo also outlined some additional proposals — namely, a 12-week trial for CPAP; the removal of the two-hour minimum of continuous recorded sleep if the recorded events equal at least the required number in two hours; and the deletion of the requirement that beneficiaries have moderate to severe obstructive sleep apnea.

The rule also granted preliminary approval to home sleep testing devices labeled Types II, III and IV.

While the proposed rule did give the green light for home testing, it failed to identify several specifics, such as who will provide the tests and how those tests will be regulated.

Also left out was the defining criteria for co-morbidities that will require a PSG in a lab, the reimbursement for the home sleep testing devices, and the qualifications for administering the tests, says Tom Pontzius, president of VGM's Nationwide Respiratory, Waterloo, Iowa.

Pontzius, like many in the industry, was surprised by the inclusion of Type IV devices. "It (Type IV device) ranked the lowest as far as acceptability by the MedCAC panel," he says. "Most of them didn't feel it would do an adequate enough job."

In a letter posted on the American Academy of Sleep Medicine's (AASM) Web site just days after the proposed rule, President Dr. Alejandro Chediak said that the organization would challenge CMS's inclusion of Type IV devices.

2. The 12-Week Trial
The inclusion of a 12-week trial period for CPAP may change the way HMEs do business. What CMS could mean is that CPAPs will fall under a rental period.

"Say, you try it for 12 weeks. If it works, they (patients) can buy a CPAP or they keep the one they've got," says Don Bradley, CTO of Braebon Medical, Ontario, Canada. "That's going to be interesting to see."

Certainly, the final rule will need to define implementation guidelines. Marcia Nusgart, R.Ph., executive director of the Coalition of Respiratory Care Manufacturers, Bethesda, Md., says it would be helpful for CMS to establish parameters for a second trial if the first one fails. Although CMS mentioned autoCPAP briefly, Nusgart hopes that the final rule also will give consideration of using this device in the 12-week trial period.

3. AASM's Home Sleep Testing Guidelines
To address the question of regulations, the American Academy of Sleep Medicine (AASM) published its own set of clinical guidelines for home sleep testing in December. The "who" according to AASM is abundantly clear: Only board-certified sleep specialists/practitioners should be allowed to perform and interpret tests and educate patients.

"Obviously a lot of people will think that's self-serving, but we think that the people who have the most expertise should be doing these studies," says Dr. Nancy Collop, AASM spokeswoman and board member.

Pontzius argues that the absence of enough qualified sleep professionals could hinder access if that requirement is put into place. He says that while sleep physicians should interpret the home study, not everything needs to be done by a sleep technician or sleep physician.

"If they go back to their doctor, whether he's board-certified sleep or not, there's a consistent plan of care," Pontzius explains. "The physician is basically going to say, 'Do you feel better with CPAP and are you using it? Are you compliant?' I don't know that you need a board-certified sleep physician to do that."

The AASM guidelines also outline specific circumstances in which portable monitoring is appropriate: only adult patients with a high pretest probability of moderate to severe obstructive sleep apnea who exhibit no symptoms of co-morbid medical or sleep conditions. The devices, which should enable manual scoring, must record airflow, respiratory effort and blood oxygenation with biosensors conventionally used for in-lab PSG, according to AASM.

"These (guidelines) were meant to be a starting point. There's lots more that needs to be done," Collup says. "If you look at the accreditation standards for polysomnography, there's a whole level of complexity to the quality assurance program … There's a whole level of things that probably apply to home sleep testing as well that just haven't really been developed because there's not broad usage of it."

The likelihood of CMS taking these guidelines into consideration for the final rule is high, predicts Pontzius, "because it's all that's out there right now."

4. Not All Portable Devices Are Created Equal
As providers begin preparing for the final rule, investigating the types of equipment available is a must. The difference between Types II, III and IV boils down to the amount of information recorded.

Think of Type I devices as in-lab PSGs. Type II devices are basically unattended Type 1, says Kathryn Hansen, director of Sleep Wellness Centers, St. Joseph Healthcare, and executive director of the Kentucky Sleep Society, Lexington, Ky. CMS defines Type II devices as having a minimum of seven channels, including EEG, EOG, EMG, ECG-heart rate, airflow, respiratory effort and oxygen saturation.

Type III devices record four to seven channels. The propose rule identifies these channels as ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), ECG-heart rate, and oxygen saturation.

Type IV devices measure only one or two parameters, such as oxygen saturation or airflow. "Your Type IV is basically oximetry," Hansen explains.

Hansen says that more parameters reduce the chances of false negatives and false positives, which is critical to an accurate diagnosis. The distinction could be an important one for reimbursement. "Technically inadequate studies or negative home studies automatically punt that patient into the lab for a Type 1 study, but there's a caveat here. How do we get paid?" Hansen questions. "There is no established protocol yet to say that CMS is going to pay for every negative home study that's done ultimately in the lab."

5. The Changing Relationship with Sleep Labs
One point of contention is that home sleep testing will impact the relationship between provider and sleep lab.

"You have to look in different markets," Pontzius says. "How is that number dwindled anyway because sleep labs are self-dispensing CPAPs? Are home care providers looking at it from a standpoint, 'Hey, if the sleep lab can dispense CPAPs, why can't I do diagnostic tests now?' "

On the other hand, home sleep testing is likely to offer respiratory providers new opportunities to partner with sleep labs to create a complete program. "Look at it from a referral source standpoint. Do I want to determine if I call a number, are they going to be able to take any test? Or do I have to say can you do this or can you do that?" Pontzius asks. "More referral sources are going to prefer to call one number."

In fact, home sleep testing could impact relationships in a positive way, for everyone involved, including patients.

"The patient is better off because each of the disciplines used their expertise and their credentialing for keeping the patient in the center," Hansen says. "That's really where we can find a common thread. Does that mean one or the other one is going to do home monitoring at the exclusion of the other? No, I think it's going to be both individuals can work toward collaborating on home monitoring."

Presumably, home sleep testing will create more opportunities for both sleep labs and providers. Sleep labs likely will benefit from the increased screening, if indirectly, says Edmund Shaw, RPSGT, product manager of sleep diagnostics, Covidien, Boulder, Colo. "We believe as more people are screened for OSA, there will be an increased number of referrals to sleep labs (when) a more simplified diagnostic device doesn't resolve the question," he says.

The demand created from increased testing will mean more CPAP sales and masks — which falls under the expertise of HME respiratory providers.

6. Home Testing and the Law
How much of a role providers play in home sleep testing might just follow examples already set in motion.

Bradley says: "If CMS stays the way that they've done things in the past, it will be pretty well left wide open, and they'll use something like the Stark law and say, 'Look, if you do the test, you can't be the same institution that also gives out the equipment.' "

The Stark Law allows sleep labs to administer the tests, but they are unable to also sell the equipment for Medicare beneficiaries. HME providers would have to offer the equipment instead.

Others speculate that CMS might follow the pathway of pulse oximetry. "Providers will not be able to have any financial interest in the completion or effectuation of the study itself," says Andrea Stark, president of MiraVISTA, a DME consulting firm based in Columbia, S.C. "It must remain in the hands of clinicians and protected against tampering. There should be no incentive to the final outcome. As such, I would expect that providers may be allowed to deliver the necessary components, to potentially upload the results after picking up the monitoring devices."

Pontizus says that home sleep testing devices do not protect data with a time stamp like the oximeter. "(With) the oximeter, the test can be downloaded by the home care company into a Web page, but that oximeter cannot be altered." Currently, anyone with the same software as the sleep lab could download a home sleep test and score it, he says.

Perhaps the best example of the likely outcome is the 2007 local coverage determination on CPAPs. "Only a DME supplier, itself, is prohibited from performing the polysomnographic study and then subsequently selling the CPAP to the beneficiary," says Jeff Baird, Esq., Brown & Fortunato P.C., Amarillo, Texas. "A subsidiary or affiliated entity of a DME supplier can operate as an IDTF (independent diagnostic testing facility) that conducts OSA testing. The DME supplier can sell CPAPs to qualified sleep study patients as long as the beneficiaries are given a choice of suppliers and the Medicare/Medicaid antikickback statute is not violated. It is likely that the same interpretation will apply to home OSA testing."

7. CPAP Setups Should Increase
With home sleep testing, the two certainties are that home sleep testing will be reimbursed and that the result is likely to be an increase in CPAP sales.

"When this comes to fruition, it would definitely increase the volume and rate of setups for CPAPs and BiPAPs, and oftentimes oxygen, too," Stark says.

Mary Erslon, RN, MSN, MBA, manager of health care policy, Covidien, says with CMS's approval many private payors could offer similar coverage. "This may ultimately create opportunities for HME providers to participate more directly in home sleep testing," she says.

Home sleep testing has the potential to help the many people with undiagnosed sleep apnea. "People are looking at it as an opportunity and I think it is an opportunity," Pontzius says. "In the end, the patient wins because people would rather do this at home. So, they're more apt to schedule to take the test if they're able to do it at home. You're able to reach more people, so that you don't have that backlog and then more people are going to be involved in the diagnosis and therapy aspect of it. So, in order for that to remain viable, you're going to see a lot more national and community education and awareness on OSA. I think all of those are good things and in the end, because of this, the patient is going to win, or the beneficiary in the Medicare sense is going to win, because they're going to have all of this education and they're going to be able to get tested quicker."

This article originally appeared in the Respiratory Management March 2008 issue of HME Business.

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