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.

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