pii: jc-00385-14 http://dx.doi.org/10.5664/jcsm.4218

Capitulation or Advocacy for Sleep Physicians and Patients? Timothy I. Morgenthaler, M.D., F.A.A.S.M.1; Sherene M. Thomas, Ph.D.2; Richard B. Berry, M.D., F.A.A.S.M.3

Center for Sleep Medicine, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic and Foundation, Rochester, MN; 2American Academy of Sleep Medicine, Darien, IL; 3Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL

LETTER TO THE EDITOR

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he letter to the editor by Thomas et al. in this issue1 makes several assertions as they provide a thoughtful critique and history of definitions of the apnea hypopnea index (AHI ), specifically as they pertain to evaluating obstructive sleep apnea syndrome (OSA): 1) that the differing AASM definitions for AHI over the years have been capricious and not based upon “a thorough review of the literature,” 2) that the AASM has irresponsibly made concessions to payors in choosing certain definitions of the AHI, and 3) that the AHI is an insufficient metric for best categorizing disease, and that we should have more clearly named options for polysomnographic events related to sleep apnea. Before addressing these assertions, we applaud many meritorious points in the letter. Thomas et al. nicely highlight issues that most will agree are vexing problems in the science of our field. We are speaking about a complex disease that involves neurological, cardiovascular, and neuroendocrine abnormalities that is currently simplistically defined by a fairly primitive measure of respiratory function regularity (the AHI, by whatever definition). While, on the one hand, there is a clear need to move beyond this metric, which correlates only poorly with many outcomes and manifestations of the disease, the corpus of literature that serves our community has used this measure to both define the presence and severity of obstructive sleep apnea. Although imperfect, this literature—using this limited measure—presently serves as the foundation of our current practice regarding OSA. We entirely agree that there is and has been a need for solid sleep research to discern more reliable, less expensive, and more relevant diagnostic and prognostic approaches for diagnosing and describing this increasingly prevalent disease. We believe, however, that the editorial inadvertently blurred the distinction between several separate issues. One relates to the development and purpose of a scoring manual, another relates to how one defines a disease, and yet another relates to how payors decide what they will reimburse. These are quite distinct, but do interact at times. A scoring manual is built to serve

very practical goals of improving the reliability and repeatability of interpreting the results of a test, while defining disease is far more complex, integrating scientific evidence, one’s view of health, as well as one’s cultural and anthropological ideas about normality and disability.2-4 Examples to ponder might include how modern society defines homosexuality now versus only last century. The American Psychiatric Association labeled homosexuality as a disease until 1973, when it was removed from the Diagnostic and Statistical Manual of Mental Disorders (DSM), and was only removed from the International Statistical Classification of Diseases in 1992.5 One may consider how our view of disease has (or has not) evolved in a host of other conditions such as chronic fatigue syndrome, addiction, fibromyalgia, or social anxiety syndrome. Payor decisions are similarly derived from multiple inputs, but intermingled with economics, cost-effectiveness, societal values, politics, ethics, and epidemiological information.6 The purpose of the scoring manual is to clearly define events felt by the sleep community to be of physiological significance. To this end, the AASM has led efforts to standardize definitions of sleep and, pertinent to this discussion, respiratory event scoring so that the same sleep study will result in roughly the same interpretation in all sleep centers if the scoring rules are applied. The aspiration is good inter- and intra-scorer reliability. The purpose of the scoring manual is NOT to provide diagnostic criteria for obstructive sleep apnea syndrome or to identify which patients should be treated. There is no threshold for AHI even mentioned in the scoring manual. The AASM Scoring Manual has undergone intense review and revision over the past decade using an evidence review process7 beginning in 2004, culminating in the new edition of 20078 and then moving online as a living document in 2012. The manual itself contains a detailed description of what went into these new versions and the process for ongoing change.9 Recent changes to the respiratory rules were proposed by a large group of experts, which included 5 members of the scoring manual committee, 1 registered sleep technologist, 1 AASM board liaison, 13 members of the Sleep Apnea Definitions (SAD) task force (2 of

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TI Morgenthaler, SM Thomas and RB Berry

whom were actually members of the scoring manual committee as well), and assisted by various staff of the AASM—all in all 24+ individuals. Nine of 13 members of the SAD task force had been on the evidence review committee for the 2007 edition. The manual describes the process expected for future changes. Any proposed changes, after proper vetting by experts, are examined and approved by the board of the AASM before going to publication. The AASM believes the new “living document” process fosters more timely responses to changing technology that may allow new and more accurate measures, or even measures of parameters not yet routinely used in practice to be standardized as needed by the sleep community, always with the goal that the manual results in high reliability and reproducibility in polysomnographic scoring. The ability for the manual to change over time in response to advances in science is a strength, but we will need to guard against radical changes without sound evidence and strong consensus of experts. Whenever a change is recommended, it is clear that interpretation of prior work becomes more difficult, as it must be seen within a new context. Special mention is needed regarding differing oxygen saturation criteria in hypopnea definitions. Thomas et al. would have you believe that the various modifications over time were whimsical, uninformed, and even made for wrong reasons. While we agree that there is always room for improvement, and we welcome honest differences of opinion, we would like to offer why we feel they are wrong. There are some factual errors in the rendition of the history of the AHI definitions that perhaps the authors were not aware of. The story begins at a time when many considered the accuracy limits of then available oximeters to be ± 4%. The “Chicago Paper” was then published in 1999 and recommended a 3% hypopnea, but as the authors point out, this was designed to best inform researchers at that time.10 The authors specifically indicated the recommendations should not replace the current clinical definitions of that time. It was in part for that reason that 4% was the a priori oxygen saturation used in the initial criteria for hypopnea in the Sleep Heart Health Study.11 There were considerations of replacing hypopnea definitions with arousal only criteria, but analyses at that time comparing varying definitions of hypopnea indicated that the best scoring reliability was achieved when the 4% desaturation was included in the definition for hypopnea.12 At this point in the story, we need to intersect the history of scoring criteria with that of payor decisions. Thomas et al.’s suggestion that the Centers for Medicare and Medicaid Services (CMS) chose the 4% AHI and an AHI of ≥ 5 with symptoms or AHI of ≥ 15 as thresholds for disease came about due to “lack of guidance” is simply not accurate. Prior to 2002, the official CMS definitions of OSA relied on apneas only—without acknowledging hypopneas at all. The AASM, under the leadership of John Shepard, M.D., initiated specific meetings with CMS in 20012002 and in extensive deliberations, using the best available evidence, were able to convince CMS to accept 4% hypopneas as well as apneas in their threshold definitions. The inclusion was a win for many more patients who could benefit from therapy. As well stated, “Unfortunately, this definition (the 4% AHI) will not include all patients who may benefit from treatment. But, based on current available evidence, it is an improvement over the current position that apnea alone defines OSA.”13 Journal of Clinical Sleep Medicine, Vol. 10, No. 11, 2014

By 2007, the Respiratory Task Force for the scoring manual project and the scoring manual authors recommended a 3% hypopnea definition, but the AASM directors intervened before the release of the 2007 scoring manual to prevent loss of reimbursement for CMS patients by providing for an alternative of scoring and reporting a 4% hypopnea. The reasons for these practical concerns are addressed below. Between 2007 and 2012, the scoring manual committee again recommended only using the 3% hypopnea definition. Based on this recommendation, the AASM decided to engage in efforts to persuade CMS to consider changes toward the 3% hypopnea rule. The board was hopeful of fruitful efforts with CMS, endorsed the recommendation, and the 2012 scoring manual (version 2.0) was released in the fall of 2012 with the 3% hypopnea rule. The Academy’s efforts culminated in a visit to CMS in the summer of 2013 (during the Sleep meeting) to explore this change with CMS. Unfortunately, the AASM learned there that the process to effect this single definitional change would involve a complete resurvey of the entire national carrier determination for diagnosis of sleep apnea and qualifications for CPAP reimbursement. The AASM board, informed by many letters from concerned members describing already challenging conditions that were threatening viability of many accredited sleep centers to provide services to patients,4 intervened a second time, again allowing for two possible definitions for hypopnea. Informed by membership centers of the hardship that would ensue by requiring a double scoring criteria and the reformatting of reports, the board decided it should not require accredited facilities to provide both AHIs (reporting both hypopnea definitions). We also reject the assertion that the AASM is impeding scientific discovery. There is no imperative to use rules from the scoring manual for research. A researcher may choose to use any definitions they wish (within usual ethical standards). Thomas et al. may have some misconceptions about the role of the AASM or the Scoring Manual Committee in regulating research. For example, Thomas et al. assert that “new epidemiological studies should be required to tabulate hypoxic and fragmenting disease and consequences separately.” The AASM is a professional member organization, not a police force. The AASM would have neither mechanism nor desire to “require” anything of a researcher. Instead, the AASM encourages freedom in scientific discovery, funding it generously through grants to the American Sleep Medicine Foundation totaling over 10 million dollars over the past 16 years, with a commitment of another 10 million dollars over the next 5 years. The AASM does, however, mandate use of the scoring manual rules in AASM accredited centers for patient care. Accreditation exists for “the primary purpose of ensuring that the highest quality of care is delivered to patients with sleep disorders.” The Institute of Medicine defines certain dimensions of quality: care should be “safe, effective, patient-centered, timely, efficient and equitable.”14 These goals place certain responsibilities upon the AASM and every sleep specialist. We need to listen to both the best science, the strongest consensus, AND ensure that patients have access to needed care. This is applied science for the good of patients. The authors suggest that the AASM should not consider “forces driving reimbursement,” and almost imply some sort of conspiracy theory is at work (or as they said, “bowing to political expediency”). If there is

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a conspiracy, it is on behalf of patients. Surely it is clear that if patients are not able to afford testing or treatment (due to lack of insurance coverage), access to care is neither equitable nor is care patient-centered. We note with relief that the laboratories of each of the authors of the letter utilize AASM scoring criteria in their center reports rather than limit access of poorer patients to their treatment facilities. Finally, the authors suggest that using the AHI, by any definition, does not fully characterize the severity of disease. We agree. Moving forward, the field of sleep medicine needs to identify metrics beyond the AHI that better inform us of the impact of a given amount of sleep apnea on an individual. The future of medicine will be driven by both basic science and by outcome data. We need to prove what metrics and thresholds identify patients who will benefit most from treatment. Better assessment tools to reflect improvement in alertness, mood, intellectual function, and cardiovascular risk are needed. How can we objectively capture the improvements in function that our well-treated patients report? And, when research is fruitful and a clear consensus of best practice developed, the scoring manual will certainly evolve to reflect that new standard.

CITATION

5. World Health Organization. The ICD-10 Classification of Mental and Behavioural Disorders: Clinical Descriptions and Diagnostic Guidelines. Geneva: World Health Organization, 1992. 6. Cookson R. Willingness to pay methods in health care: a sceptical view. Health Econ 2003;12:891-4. 7. Iber C. Development of a new manual for characterizing sleep. Sleep 2004;27:190-2. 8. Iber C, Ancoli-Israel S, Chesson A, Quan SF. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications. 1st edition. Westchester, IL: American Academy of Sleep Medicine, 2007. 9. Berry R, Brooks R, Gamaldo C, et al. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications, Version 2.1. www.aasmnet.org. Darien, IL: American Academy of Sleep Medicine, 2014. 10. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep 1999;22:667-89. 11. Shahar E, Whitney CW, Redline S, et al. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med 2001;163:19-25. 12. Tsai WH, Flemons WW, Whitelaw WA, Remmers JE. A comparison of apneahypopnea indices derived from different definitions of hypopnea. Am J Respir Crit Care Med 1999;159:43-8. 13. Meoli AL, Casey KR, Clark RW, et al. Hypopnea in sleep-disordered breathing in adults. Sleep 2001;24:469-70. 14. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press, 2001.

SUBMISSION & CORRESPONDENCE INFORMATION

Morgenthaler TI, Thomas SM, Berry RB. Capitulation or advocacy for sleep physicians and patients? J Clin Sleep Med 2014;10(11):1249-1251.

Submitted for publication October, 2014 Accepted for publication October, 2014 Address correspondence to: Timothy I. Morgenthaler, M.D., F.A.A.S.M., Mayo Clinic Center for Sleep Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN; Tel: (507) 393-1031; Fax: (507) 266-7772; Email: [email protected]

REFERENCES 1. Thomas RJ, Guilleminault C, Ayappa I, Rapoport DM. Scoring respiratory events in sleep medicine: who is the driver—biology or medical insurance? J Clin Sleep Med 2014;10:1245-7. 2. Scully JL. What is a disease? EMBO Rep 2004;5:650-3. 3. Pearce JM. Disease, diagnosis or syndrome? Pract Neurol 2011;11:91-7. 4. Tikkinen KA, Leinonen JS, Guyatt GH, Ebrahim S, Järvinen TL. What is a disease? Perspectives of the public, health professionals and legislators. BMJ Open 2012;2.

DISCLOSURE STATEMENT Dr. Berry has received research support from Philips Respironics. Dr. Thomas is employed by the American Academy of Sleep Medicine. Dr. Morgenthaler has indicated no financial conflicts of interest.

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Capitulation or advocacy for sleep physicians and patients?

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