The Centers for Medicare and Medicaid Services (CMS) has issued its long-awaited final coverage policy for CPAP, expanding coverage for CPAP when OSA is diagnosed using a clinical evaluation plus a positive PSG, type II, type III, and type IV test measuring three or more channels.

“The final is really similar to the proposed. It’s clear CMS believes home testing is a viable, clinical alternative to a full PSG and over time it will improve access to sleep studies,” says Phillip Porte, principal, GRQ LLC, Vienna, Va, who represents the Sleep Manufacturers Alliance.

Depending on one’s relationship to home testing, the reaction to the decision has been mixed. Henry L. Johns, BS, RPSGT, CRT, CPFT, director of sleep and respiratory services for Pulmonary & Sleep Associates of Topeka, Kan, sums it up: “If you’re talking about manufacturers of equipment, they are going to be thrilled. If you’re talking about the people who are looking to make a fast buck off of Medicare, they are going to be thrilled. If you are talking about the sleep community and sleep physicians, they are not going to be quite so thrilled unless they are poised to jump into home testing.”

Ready to jump in or not, the decision is here. The determination to include type IV devices has been met by concern with many expressing that caution should be used when employing such devices. Regarding the CMS decision to include type IV devices, Porte says, “We are supportive of type II, III, and IV devices, but we want to look more carefully at how they are defining type IV devices.”

Others are also displeased about type IV inclusion. “A type IV device just does not do enough. Anyone with a modified oximeter can do a test. [Based on the CMS ruling] if their oximeter picks up oximetry data, heart rate data, and airflow, that’s enough,” says Johns. “The AASM was against the use of the type IV monitors. They did not think that was adequate.”

Beyond naming types of approved devices, CMS has limited CPAP coverage to 12 weeks. For subsequent coverage after the 12-week period, the beneficiary must show improvement as a result of CPAP. But questions remain regarding this point, mainly, what defines improvement? “The loose end question here is what type of documentation and kind of clinical data, if any, as opposed to pure judgments, is going to be needed to continue the therapy?” Porte asks. Though “improvement” is undefined, Johns suspects that CMS will want quantifiable data. “I would hope that what that means is they are going to require people to use downloadable devices to qualify what improvement is,” he says. “I would hope they use something like that rather than a simple hour meter because that is going to be a much more beneficial set of parameters.”

The decision also stated that to be considered positive for OSA, a patient must have either an apnea-hypopnea index (AHI) or respiratory distress index (RDI) greater than or equal to 15 events per hour or, according to the memo, an “AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.”

CMS also removed the 2-hour continuous recorded sleep time requirement and took out the required documentation of “moderate to severe OSA” and “surgery as a likely alternative” as a condition for CPAP coverage.

Insurers make policy changes

Sleep Report is aware of at least one insurer that has posted a new clinical policy related to diagnosis of OSA. According to an Aetna bulletin, “Aetna considers any of the following diagnostic techniques medically necessary for members with symptoms suggestive of OSA: Full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility; unattended home sleep monitoring using a Type II, III, or IV device. ...”

Other insurers are expected to follow the lead of CMS. “I think most private insurers look to CMS to see what they cover, and then whatever CMS does, they will approximate,” Johns says. “They will either copy it or come close to it.”

What’s next?

Local Coverage Determinations (LCDs), which will likely resemble CMS’ new policy for CPAP reimbursement, will be issued. “In terms of the LCD, we know that the DME MAC medical directors have this issue on their radar, and we are moderately confident we will see  virtually identical LCDs. Those LCDs will address some of the other questions,” Porte says. “All of those small, but large issues will probably be addressed. We will just have to be patient.”

Read the decision memo in its entirety here.