On Wednesday, September 12th, the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) on coverage of CPAP treatment based on portable monitor testing met in Baltimore, MD. The committee consisted of a vice-chairman, nine voting members, and four non-voting members. Of the committee’s 14 members, 13 were physicians and one of these was a pulmonary physician. None of the professional organizations were represented on the committee. The ATS, ACCP and AASM submitted written statements and representatives from these professional societies made 5 minute presentations. Dr. Sam Kuna and Gary Ewart represented the ATS.
CMS submitted specific questions to the committee on whether clinical evidence shows that various diagnostic approaches produce accurate diagnosis of OSA (see below). The panel voted on a scale of 1 to 5 with 1 indicating no confidence, 3 indicating moderate confidence, and 5 indicating very confident. For diagnosis with clinical evaluation and PSG, the voting members averaged 4.3; for diagnosis with clinical evaluation and a home test, the average was 3.6; and for diagnosis with clinical evaluation only, the average was 2.1.
There was a clear consensus on the committee not to recommend CPAP therapy based on clinical evaluation alone. Many of the presenters commented on the limitations of the PSG and the summary vote of 4.3 instead of 5 for this "gold standard" indicated to us that the committee got that message. The committee seemed neutral regarding approval of portable monitor testing and left the door wide open for CMS to make whatever decision it wants. In the voting, Type 2 monitors came out nearly equivalent to in-lab testing and there was recognition from the comments made that their approval would probably not lead to a significant change in clinical practice. Not surprisingly, the major focus was on Type 3 and Type 4 monitors. Concerns were raised that widespread application of these portable monitors could lead to their indiscriminate use. There was discussion about whether approval could be restricted to physicians with expertise managing patients with sleep disordered breathing but it was not clear that CMS is able or willing to do this. CMS does not base their decisions about coverage on cost. However, one might anticipate that the effect of approval of CPAP coverage based on portable monitor testing may have a greater impact on CPAP expenditures than its effect on projected payments for PSGs vs unfettered portable studies.
According to the CMS website, CMS will publish a proposed decision by 12/14/07, collect public comments on the proposal (60 days after publication of proposed rule), and then publish a final decision by 3/14/08.
Detailed information about the CMS determination process and the MedCAC meeting, including the outstanding Agency for Healthcare Research and Quality’s Technology Assessment on portable monitor testing can be found at:
http://www.cms.hhs.gov/mcd/viewnca.asp?from=basket&nca_id=204&viewAMA
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+%28CPAP%29+Therapy+for+Obstructive+Sleep+Apnea+%28OSA%29%3AOpen%3A2nd+Recon%3A6
Written Comments Submitted by ATS to CMS
April 13, 2007
Re: AAO-HNS Request to include home monitoring in NCD 240.4 for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)
Dear CMS:
The American Thoracic Society (ATS) appreciates the opportunity to comment on the American Academy of Otolaryngology-Head and Neck Surgery’s formal request to include the use of portable multi-channel home sleep testing devices as an alternative to facility-based polysomnography for the diagnosis and treatment of obstructive sleep apnea (OSA) requiring CPAP. The ATS has compelling interest in the treatment of CPAP. We note that 60 percent of the CPAP services (CPT 94660) provided to the Medicare beneficiary population are provided by pulmonary physicians.
Portable Multi-Channel Monitoring Devices for Diagnosis of OSA
Current national Centers for Medicare and Medicare Services (CMS) policy specifies that only polysomnography done in a facility-based sleep study laboratory can be used to identify patients with OSA requiring CPAP (240.4).
The ATS acknowledges there is growing clinical experience with unattended sleep monitoring devices for diagnosis and management of OSA in the sleep medicine community. We note that unattended sleep monitoring devices appear to be successfully used in several clinical settings in Europe, Canada and some managed care systems in the U.S.
However, published research has not keep pace with the growing body of clinical experience. To date, there does not yet exist published data that compares the effectiveness of unattended sleep monitoring devices to polysomongraphy performed in a facility-based sleep study laboratory. The ATS recognizes the urgent need for such studies to be conducted.
ATS will follow the CMS re-evaluation of this issue with great interest. The primary focus of ATS at this point is to promote the generation of new knowledge in the area of Portable Monitoring for OSA. To this end, the ATS will be sponsoring, together with AASM, ACCP and ERS, a workshop on Research Priorities in Ambulatory Management of OSA to be held Oct 14-16, 2007. This aim of this workshop will to identify key research questions and develop recommendations concerning technological and study design aspects of outcomes-based studies on ambulatory case management of OSA. A summary of these recommendations will be published in the Proceedings of the American Thoracic Society. It is hoped that these recommendations will serve to stimulate and guide future research initiatives in this area.
The ATS recognizes that access to diagnosis and treatment of OSA is limited for some segments of the Medicare population, and that these needs are pressing in some sectors. Re-evaluation of the current body of evidence by CMS may find that strong evidence for use of unattended portable monitoring is still lacking for the Medicare population. The ATS believes that this situation may represent an ideal opportunity for Medicare "Coverage with Evidence Development". Such an initiative could benefit from design recommendations developed by the upcoming Ambulatory Management Research Workshop.
AHI Criteria
CMS also received other requests to change the criteria for determining the Apnea-Hypopnea Index (AHI). It is suggested to change the criteria, from:
The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep recorded by polysomnography using actual recorded hours of sleep (ie, the AHI may not be extrapolated or projected).
The proposed new criteria is:
The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep or less, if the actual number of AHI episodes recorded is 30 or more in less than 2 hours, recorded by polysomnography using actual recorded hours of sleep (ie, the AHI may not be extrapolated or projected).
The ATS supports the request to revise the 2 hour minimum standard in order to provide less restrictive diagnostic criteria, particularly for split-night polysomnographic studies.
Again, the American Thoracic Society appreciates the opportunity to comment on this important coverage issue for Medicare beneficiaries. We stand ready to work with CMS to develop revised coverage policy for portable multi-channel monitoring devices for diagnosis of OSA as evidence supports its expanded role.
Sincerely,
American Thoracic Society
Questions submitted to MedCAC by CMS with Voting Scores
The numbers in parentheses are the average score of the voting members/entire committee. Voting was on a scale of 1 to 5 with 1 indicating no confidence, 3 indicating moderate confidence, and 5 indicating very confident.
Question 1. How confident are you that there is sufficient evidence to determine if each of the following strategies can in routine use, produce an accurate diagnosis of OSA for the prescription of CPAP?
- Diagnosis based on Clinical Evaluation (2.1/2.1)
- Diagnosis based on Clinical Evaluation plus PSG (4.3/4.5)
- Diagnosis based on Clinical Evaluation plus Home Testing Device (3.6/3.3)
Question 2. For each OSA diagnosis strategy for which there is enough evidence in question 1, how confident are you about its sensitivity (ability to minimize false negatives) and specificity (ability to minimize false positives)?
- Diagnosis based on Clinical Evaluation only (2.2/2.2)
- Diagnosis based on Clinical Evaluation + PSG (4.3/4.4)
- Diagnosis based on Clinical Evaluation + Type 2 PM (3.6/3.7)
- Diagnosis based on Clinical Evaluation + Type 3 PM (3.3/3.3)
- Diagnosis based on Clinical Evaluation + Type 4 PM (2.1/2.1)
Question 3. This question concerned confidence in risk factors for sleep apnea as indicators of the diagnosis of sleep apnea. The committee decided not to vote on this question.
Question 4. CPAP is currently a standard treatment for OSA. Defining successful treatment as combined subjective improvement of OSA, clinical signs/symptoms and continued patient use of CPAP for ≥ 2 mo, how confident are you that there is sufficient evidence to determine the ability of each of the following diagnostic strategies to accurately predict successful treatment of OSA with CAP
- PSG + clinical evaluation (4.2/4.1)
- Home testing + clinical evaluation (3.3/3.2)
- Clinical evaluation + trial of CPAP (2.6/2.5)
- Clinical evaluation alone (1.8, 1.7)
Question 5. How confident are you that each of the following diagnostic strategies will accurately predict successful treatment of OSA with CPAP?
- PSG + clinical evaluation (4.0/3.8)
- Home testing + clinical evaluation (3.3/3.2)
- Clinical evaluation + Trial of CPAP (2.6/2.7)
- Clinical evaluation alone (1.9/1.8)
Question 6. How confident are you that no clinically meaningful harm to patients will be caused by a Trial of CPAP strategy as an alternative to strategies that require a positive prior PSG or home sleep test before CPAP? (2.7/2.9)
Question 7. How confident are you that your conclusions can be generalized to:
- The Medicare population (2.8/2.9)
- Providers in community practice (facilities/physicians) (2.7/2.7)
