Battle Over Home Sleep Testing Heats Up

BALTIMORE–A battle among sleep industry stakeholders is brewing
as CMS works through a review of its national coverage
determination on testing for CPAP therapy.

Currently, CMS policy specifies that only polysomnography tests
done in a sleep lab are acceptable to diagnose patients with OSA
and prescribe a CPAP device. 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 in mid-March. (See HomeCare Monday, March 26.)

“Home sleep testing is a validated alternative and an important
step in improving recognition and control of OSA,” according to the
academy. “Additionally, the current reimbursement paradigm of high
reimbursement for [polysomnography] and low reimbursement for
treatment is not only a waste of precious resources, but also
discourages more appropriate focus on rapid diagnosis and effective
treatment for OSA.”

CMS has set a public meeting of its Medicare Evidence
Development and Coverage Advisory Committee for Sept. 12. All
aspects of the NCD on diagnosing OSA will be open for review.

Based on comments CMS received earlier this year, the meeting is
shaping up as a skirmish among medical professionals and other
parties who are widely divided in their opinions on the policy:

–The American of Academy of Sleep Medicine said it objects to
home testing, asserting that there is a lack of data to support a
change in policy and labeling as “a myth” the idea that there are
not enough sleep facilities to deal with the number of patients.
“There is no evidence to suggest that a change in the NCD policy
for portable monitoring will have a significant effect on patient
access,” the AASM commented. The group also pointed to studies that
it said have not provided evidence in support of portable
monitoring for the diagnosis of OSA and said more research must be
done. In addition, the AASM said, “Wide use of portable monitoring
by physicians and surgeons not trained in its use or in the
comprehensive management of patients with sleep disorders will
likely result in adverse patient outcomes. There is credible
evidence that patients managed for OSA at accredited sleep centers
have better outcomes.”

–Robert D. Hoover Jr., M.D., MPH, FACP, writing on behalf of
Longmont, Colo.-based Sunrise Medical and its DeVilbiss division,
said the company “supports the expansion of home diagnostic
testing” to include comprehensive portable and modified portable
sleep apnea testing. “These devices, in combination with objective
and subjective clinical data such as body mass index, neck
circumference and a validated sleepiness scale, have consistently
demonstrated comparable predictive value to that obtained by
facility-based, attended [polysomnographic studies],” Hoover
said.

–Mickey Letson, president of The Letco Companies, Decatur,
Ala., noted: “By allowing the in-home qualification of CPAP, the
Medicare system would see substantial savings as well as provide
the much needed access to these products and a much faster speed
than is currently achieved through in-lab qualification. The
technology currently exists to perform in-home CPAP
qualification.”

–The American College of Chest Physicians disagrees. While
portable monitoring may “ultimately have a place in the diagnostic
armamentarium of physicians evaluating and treating patients with
sleep apnea,” the group said, “this approach has not yet been
validated well, its limits clarified, nor the costs and benefits
assessed beyond the unsupported assumption that it must be less
expensive than polysomnography. Portable monitoring will require
judicious application to avoid errors in diagnosis, and carefully
designed investigations are underway. Until the results of these
studies are available for critical review, modification of the CMS
[NCD] to include at-home unattended portable monitoring is
premature and not in the best interests of patients with
obstructive sleep apnea or other sleep disorders.”

–The National Sleep Foundation, on the other hand, champions
using all meaningful testing that is available. “NSF encourages CMS
… to consider the prevalence and consequences of sleep apnea,
current access-to-care barriers, and the need to emphasize
long-term management when establishing policies which influence
those with sleep apnea and the health care professionals caring for
them. Physicians knowledgeable in the care of patients with sleep
apnea should be able to use all evidence-based assessment and
treatment procedures to maximize identification and management of
those with sleep apnea.”

–In its comments, the American Association for Homecare said it
supports a revision to the current NCD that would “permit the use
of portable, multi-channel sleep testing in the home as a
diagnostic alternative to facility-based polysomnography.” The
association also recommended revising the criteria for determining
the Apnea-Hypopnea Index, and developing a policy “for the use and
coverage of positive airway pressure therapy for a select group of
severe patients not yet evaluated through formal sleep
testing.”

At its September meeting, MedCAC may consider the AHI and
additional issues, including qualifications for personnel who
perform sleep tests.

“Sleep testing in the home would be valuable if licensed
personnel were performing these tests,” the Respiratory Care Board
of California noted in its comments. “If you decide to allow for
reimbursement for tests performed in the home, it is crucial that
you require licensed personnel to perform these tests.”

The American Association for Respiratory Care strongly
recommended that CMS require testing facilities to be accredited,
and also said for those administering the tests, “it is important
for Medicare to set a high standard in terms of personnel
qualifications to help assure a high quality of services provided
to the Medicare beneficiary.”

The MedCAC meeting has been scheduled from 7:30 a.m. to 4:30
p.m. at 7500 Security Blvd., Windsor Mills, Md. CMS said it would
post additional information about the meeting at a later date.

The agency said it expects to complete the review by March 13,
2008.

To view comments on the NCD, click here.