On March 3, CMS issued its Decision Memo setting out its final coverage policy on sleep testing for the diagnosis of obstructive sleep apnea (OSA). As noted in the CMS press release, the Decision Memo establishes “nationally consistent coverage for sleep testing for the diagnosis of OSA.” The full Decision Memo can be accessed at this link. The Decision Memo identifies the types of sleep tests that may be used by a Medicare Beneficiary’s treating physician in establishing an OSA diagnosis as follows:
1. Type I Polysomnography (PSG) is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.
2. A Type II or a Type III sleep testing device is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
3. A Type IV sleep testing device measuring three or more channels, one of which is airflow, is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
4. A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone is covered when used to aid the diagnosis of obstructive sleep apnea (OSA) in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.
The new coverage element is the inclusion of devices that fall into the last category and that the Academy had recommended be considered as a Type V device. The following information provides further details on some of the information set out in the twentysevenpage Decision Memo. During the open comment period, CMS received 45 comments and noted that “the stakeholder community itself has been clearly polarized into opposing PSG and HST camps.” CMS categorized the four comments from medical specialty societies as
American Academy of Neurology Professional Association (AANPA) The AANPA believes that the use of Level IV devices to diagnose OSA, or the use of devices with actigraphy, oximetry, and peripheral artery tone without respiratory airflow are premature, and that further prospective studies are needed to clarify their place in the diagnosis and treatment of OSA. American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) The AAO-HNS supports the extension of Medicare coverage of OSA diagnosis to portable HST devices. They are opposed to a requirement that limits interpretation of sleep studies to a limited subspecialty group of physicians. The AAO-HNS states that such restrictions will limit access to optimal care for the diagnosis and treatment of OSA.
American Academy of Sleep Medicine (AASM) The AASM is opposed to the use of Level IV devices without a channel to measure respiratory airflow, or the use of devices with actigraphy, oximetry, and peripheral artery tone to diagnose OSA. The AASM claims that such devices provide only an indirect “respiratory analysis” measure and therefore fail to provide adequate information to differentiate between central, mixed and obstructive sleep apnea.
American Thoracic Society (ATS) The ATS endorses the CMS decision to expand testing for the diagnosis of OSA to include the use of portable monitoring devices in those adult beneficiaries with clinically suspected OSA. The ATS qualifies this position by stating the use of portable monitoring is not yet well validated in patients with underlying complex pulmonary, cardiologic or neuromuscular disorders. They recommend that these patient groups not have portable diagnostic studies performed until such a time when evidence is made available for these particular patient groups. In addressing specific comments, CMS provided the following responses:
Sleep Test Classification
(AASM recommended that PAT devices, if covered, be classified under a new Class V. In its analysis, CMS says that “devices measuring actigraphy, oxygenation, and PAT may be classified as Type IV devices, we are, for clarity, providing a specific conclusion regarding such technology.” The following is the specific response on classification.) CMS is not responsible for the existing categorization system of sleep testing devices. The system was established 15 years ago by the American Academy of Sleep Medicine (AASM). We understand that the system may pose challenges for classifying certain sleep testing devices, but CMS believes that the OSA community is best suited to seek any modification of the classification system directly with AASM. With respect to the effect of AASM classification of a sleep testing device on time to market, this comment is outside the scope of this decision. We do not believe it is necessary to separate the discussion of Type II and Type III devices. Because there has been some debate in the sleep community about the classification of devices using PAT technology, we have for clarity separately discussed the evidence regarding PAT technology.
Sleep Test Interpretation
(The response is specific to Part B coverage. The Decision Memo does not address or modify the criteria relating to coverage for CPAP.) We agree that a sleep test should be interpreted by a skilled and knowledgeable physician. We also agree that a physician who is board certified or board eligible in sleep medicine is likely to have those characteristics across the spectrum of sleep disorders diagnosis and management. However, we believe there may also be other physicians that have adequate skill and knowledge to appropriately interpret sleep test results. This decision speaks specifically to the coverage of sleep testing devices used to diagnose OSA. Comments about specific physician specialties are outside the scope of this NCA. As provided at 42 C.F.R. § 410.32,”…diagnostic tests must be ordered by the physician who is treating the beneficiary…and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.”
Distinguishing between OSA and Central or Complex Sleep Apnea
(The AASM comment was that the use of Level IV devices to diagnose OSA or the use of devices with actigraphy, oximetry, and peripheral artery tone without respiratory airflow are premature, and that further studies are needed before coverage is extended to this category of testing.) The body of evidence pertinent to the use of HST devices for the diagnosis of OSA is more robust than it was just a few years ago. In addition to our own review of the evidence, this is supported by the more favorable September 2007
MEDCAC scores for HST compared to the September 2004 MCAC scores. Thus, we find that the evidence is sufficient to conclude that, in appropriately selected patients, some home sleep testing monitors will identify a significant proportion of patients with OSA. We expect that patients who are suspected to have central or mixed causes of sleep apnea based on clinical findings or diagnostic testing would be referred to physicians with appropriate expertise in these more complex conditions.
Guidelines on When HST is an Appropriate Diagnostic Tool
It is important to note that we are not requiring that HST be done in the place of PSG. If the beneficiary’s treating physician has good reason to believe that HST will be an inadequate diagnostic tool for a particular beneficiary’s condition, we expect that the physician would order a PSG instead. We expect the treating physician to consider all relevant information pertaining to the health status of a particular beneficiary before recommending the use of HST or PSG.
Guidelines on Sleep Evaluations before Testing and Patient Education
We require that beneficiaries have clinical signs and symptoms of OSA as a condition of coverage for sleep testing. These would logically be ascertained in the course of a sleep evaluation prior to testing. There are several evaluative instruments that might be used as part of a pre test evaluation and a requirement to use a specific algorithm is not within the scope of this decision. As with other diagnostic tests, we expect that the treating physician who orders a test will ensure that the patient is provided with sufficient information to enable the test to be performed correctly.
Review of Raw Data
(AASM policy is that a review of raw data should be incorporated in an analysis of a sleep test.) Automated scoring is a feature of several sleep test technologies and is not a unique characteristic of PAT based technologies. We are not making a determination on the use of automated scoring of sleep studies in this NCD. The physician who interprets the test remains ultimately responsible for the accuracy of the interpretation.
Consistency with LCDs and the LCDs relating to CPAP Coverage
(The Academy noted the disconnect between the Part B and DME coverage and sought clarification.) We believe that this NCD does not conflict with the NCD on CPAP for the treatment of OSA. Regarding LCDs, this NCD on sleep testing supersedes all applicable local policies and local Medicare contractors will take such steps that may be necessary to align their local policies with the NCD.
Site of Service
This final decision covers portable sleep testing whether furnished in a facility or outside of a facility. We note for clarity that Type I sleep testing is, by definition, performed within a facility. We expect that the beneficiary’s home will be the site of service when the test is not furnished in a sleep laboratory facility. However, we are permitting local Medicare contractors to determine the conditions under which other locations might be appropriate.