It’s a Go for Home-Based Sleep Testing

BALTIMORE–Late Friday, the Medicare Evidence Development and
Coverage Advisory Committee recommended changes to CMS’ national
coverage determination on coverage of continuous positive airway
pressure therapy for obstructive sleep apnea. The proposed decision
memorandum addressed several issues, including the controversial
topic of home-based testing for OSA–and it got the go.

Under current policy, OSA patients must be diagnosed through a
sleep lab test in order for Medicare to cover the cost of CPAP
therapy. But a request from the American Academy of
Otolaryngology-Head and Neck Surgery asking the agency to accept
in-home testing prompted CMS to open its policy for review earlier
this year. (See
HomeCare Monday, July 9.)

CMS said it received 680 comments on the request, with 388 (57
percent) of the commenters supporting expansion of coverage to
include the use of home sleep testing, while 292 (43 percent)
disagreed.

In the memo, MedCAC recommended:

–Coverage of CPAP be initially limited to a 12-week period to
identify beneficiaries diagnosed with OSA with subsequent coverage
for those who benefit from the therapy;
–Coverage of CPAP when diagnosis involves using a clinical
evaluation and polysomnography performed in a sleep lab;
–Expansion of CPAP coverage to those diagnosed through a
combination of a clinical evaluation and unattended home sleep
testing using a Type II, III or IV device;
–Modification of the criteria for a positive sleep study “to
remove the requirement for a minimum two hours of continuous
recorded sleep and to recognize shorter periods of continuous
recorded sleep if the total number of recorded events during that
shorter period is at least the number of events that would have
been required in a two-hour period;” and
–Deleting the current distinct requirements that an individual
have moderate to severe OSA and that surgery is a likely
alternative.

Additionally, citing a lack of sufficient evidence that clinical
diagnosis alone or clinical diagnosis in combination with devices
other than Type I, II, III, or IV adequately identifies
beneficiaries with OSA that will benefit from CPAP, the committee
proposed expansion of Medicare coverage for CPAP in such instances
only when provided in the context of a clinical study.

Contacted on Saturday, Robert D. Hoover, Jr., MD, MPH, FACP,
chief medical officer for DeVilbiss Healthcare, Somerset, Pa., said
the outcome of the memo “closely tracks” the voting of the MedCAC
panel after a Sept. 12 meeting on the issues. But some points need
further clarification, he said.

“Interestingly, while they provide coverage for the initial 12
weeks, there is no mention of what documentation is required for
continuing therapy past that point. I assume that it will be up to
the DME medical directors to outline those requirements,” he
said.

Hoover was also surprised that CMS afforded coverage to Type IV
devices and did not address home titration. “Type IV devices have
the fewest number of monitoring channels and also the lowest
diagnostic ‘precision’ in the medical literature,” he said. “Also,
the decision does not address home titration, which is essential to
a diagnostic strategy that attempts to avoid the high cost of a
facility-based study. Since the decision is published as a draft
with comments, I suspect physicians and providers will seek
clarification on this issue.”

According to the memo, “No single tool reliably identifies all
beneficiaries who will benefit from a CPAP device while excluding
those who will not. Thus, we believe that the perfect tool for
diagnosing OSA in all Medicare beneficiaries is not
[polysomnography, home sleep testing] or trial by CPAP. We believe
that different beneficiaries will benefit from different
strategies. The preferred strategy in a given individual will
likely vary with the severity of the patient’s symptoms, local
access to a sleep laboratory, and the need to rule out other
conditions that may cause symptoms similar to OSA, for example
nocturnal seizures or narcolepsy.”

Devices that do not fit into the Type II, III or IV category got
a nod as well.

“CMS has left the door open for coverage of other home
diagnostic systems that don’t fit neatly into a Type II, III or IV
category. Coverage of those technologies through clinical studies
will add to the body of evidence for those devices and potentially
gain them formal coverage in the future,” Hoover said.

CMS’ final decision is due in March of 2008.

View the proposed decision memo in full or to
submit comments.