OCST Is the Hot Button Issue for the Sleep Disorders Committee
By M. Steele Brown, Special to the Bulletin As the nation grows older and more obese, out-of-center sleep testing (OCST) is keeping the Sleep Disorders Committee of the American Academy of Otolaryngology—Head and Neck Surgery up at night. Portable monitoring, home sleep testing, and ambulatory sleep testing for obstructive sleep apnea (OSA) are influencing the payment structure, with insurer spending on the procedure under government scrutiny. According to the Office of the Inspector General in the Department of Health and Human Services, Medicare spending on sleep testing increased nearly 280 percent from 2001 to 2009—from $62 million to $235 million. The problem for physicians, said Edward M. Weaver, MD, MPH, associate professor and chief of sleep surgery in the department of otolaryngology—head and neck surgery at the University of Washington in Seattle, is that insurers are pushing for in-home testing using a portable device in lieu of the more expensive, overnight sleep lab option. “Some health plans now require OCST for suspected sleep apnea, and probably more plans will require it in the future,” Dr. Weaver said. “This change alters the landscape of reimbursement for sleep medicine, because polysomnography costs and reimburses much more than OCST. In-lab testing has been the major source of revenue for most sleep medicine programs.” Academy Sleep Disorders Committee Chair Pell Ann Wardrop, MD, medical director of the St. Joseph Hospital’s Sleep Wellness Center in Lexington, KY, said that she sees one insurer’s new policy for sleep testing as a good example of the problem. “In a couple of geographic areas, the insurer has initiated a new program that requires patients be tested with a home sleep test unless these patients have specific co-morbid conditions,” Dr. Wardrop said. “That is fine in some cases, but many times the patients receive the instructions by mail, and even if that is not the case, the physician cannot individualize the test for the particular patient. Right now the Academy is working to advocate for payment for surgical sleep procedures and access to a variety of treatment options for sleep patients in both Massachusetts and New York, as well as a couple other areas of the country.” Dovetailing with the sleep center controversy is the growing interest in outcomes-based care, Dr. Weaver said. “Models of care are being considered where reimbursement and coverage of services are determined by outcome, not just service provided,” he said. “For example, Medicare will cover a continuous positive airway pressure (CPAP) device only if the patient demonstrates adequate use during the initial trial period. Medicare defines adequate use—objectively measured by the CPAP device—as an average of four hours per night on 70 percent of nights during a consecutive 30-day period within the first 90 days of the CPAP trial.” Both issues may have downstream effects on the practice of sleep surgery, as more OCST may provide easier access for patients to be diagnosed with OSA and increase the need for sleep surgery, Dr. Weaver said. “Some speculate these patients will not receive as thorough a trial of CPAP, which may translate to a higher rate of failed CPAP patients, which in turn would further increase the downstream need for sleep surgery,” he said. “Likewise, greater scrutiny for CPAP coverage will likely identify CPAP failures more readily and may result in more patients being referred for surgical treatment alternatives to CPAP. One of the challenges for otolaryngology is to have a sufficient number of surgeons trained adequately in the surgical treatment of sleep apnea.” Education According to Dr. Wardrop, the Sleep Disorders Committee has spent the last year and a half updating the bulk of the patient education material related to sleep disorders on the AAO-HNS website. “We have also updated many of the sleep-related clinical indicators and policy statements as part of (AAO-HNS President) Rodney P. Lusk, MD’s, Web Content Relevancy Project—an Academy-wide push to index everything and make our search functions work better.” Dr. Wardrop said the members of the committee have also developed several soon-to-be-released AcademyU® sleep-related modules, and are also working collaboratively with other committees and societies on quality issues and payment/access to care issues. “We are also involved in the research arena,” she said. “The committee identified several areas in which there was a paucity of clinical data. Based upon these discussions, Kathleen Yaremchuk, MD, and Andrew J. Senchak, MD, are both leading studies investigating the effect of tonsillectomy in adult OSA.” It is important to recognize that sleep-disordered breathing and OSA are increasingly diagnosed in children, said Ron Mitchell, MD, professor of Otolaryngology and Pediatrics at UT Southwestern Medical Center, Dallas and chief of pediatric otolaryngology at Children’s Medical Center Dallas. This reflects the recognition that OSA affects up to 2 percent of normal-weight, and 20 percent of overweight and obese children. Adenotonsillectomy (T&A) is the first line surgical treatment for OSA in children with more than 500,000 procedures performed annually in the United States. There is an ongoing debate about indications for polysomnography (sleep studies) prior to T&A for OSA in children. The AAO-HNSF published a guideline in 2011 on polysomnography for sleep-disordered breathing prior to tonsillectomy in children (http://oto.sagepub.com/content/145/1_suppl/S1). It consists of five evidence-based action statements that deal with indications for polysomnography, the need to advocate for polysomnography in certain groups of children, the need to communicate the results of polysomnography with the anesthesiologist, indication for admission to hospital after T&A, and the need to obtain full-night polysomnography instead of portable monitoring to diagnose and quantify OSA. The purpose of the guidelines is to define actions that could be taken by otolaryngologists to deliver quality care, Dr. Mitchell said. Annual Meeting Research Track This year’s Translational Research Mini-Program at the AAO-HNSF 2012 Annual Meeting & OTO EXPO in Washington, D.C., will continue the focus on sleep. Dr. Weaver, the Mini-Program chair, said the committee that put the event together sought to cover a broad spectrum of topics relevant to sleep apnea and surgical treatment, with a focus on research topics and data. The topics range from basic science relevant to understanding the upper airway pathology (miniseminar No. 1), to data on emerging surgical treatments (miniseminar No. 2), to research that influences policies relevant to sleep surgery (miniseminar No. 3). “This Mini-Program will highlight major advances in the field of sleep apnea research relevant to surgery, and it will point to important areas in need of deeper understanding at each level from bench to policy development,” Dr. Weaver said. “We targeted speakers known to give engaging presentations.” Dr. Weaver said the committee chose speakers who have received “excellent audience feedback” in regard to their respective topics. “The guest speakers are leaders in the field of sleep medicine,” he said. “Allan Pack, MD, PhD, director of the division of sleep medicine at the University of Pennsylvania, will give the Neel Lecture on the genetics of obstructive sleep apnea. He is a world-renowned expert in the field and a dynamic speaker.” The 2012 Neel Distinguished Research Lecture will overview genetics in the context of OSA, sharing both experience and data from a large genetics study Dr. Pack is leading in Iceland, an area that provides unique advantages for genetics studies. “The Icelandic population was in isolation for centuries, so it has a relatively homogeneous gene pool, which helps for gene studies,” Dr. Weaver said. “Moreover, the population is highly supportive of gene studies, so more than half the population has provided material for complete genotyping. With a close collaboration with the sleep medicine program in Iceland—where a large number of patients have been thoroughly phenotyped for OSA, including polysomnography, airway MRI, and other anatomical and physiological measures—the data provide a unique opportunity to study genetic influences on OSA.” Atul Malhotra, MD, director of the Sleep Program at Harvard’s Brigham & Women’s Hospital and an international leader on normal upper airway physiology and sleep apnea airway pathophysiology, will be featured in the basic science miniseminar. “While otolaryngologists are expert in assessing the anatomical features of the upper airway, the physiological basis of upper airway collapse during sleep is not as well understood by most otolaryngologists,” Dr. Weaver said. “This miniseminar will highlight a world expert on physiological upper airway dynamics and how it relates to OSA. An intriguing pathophysiologic theory about OSA is that vibration trauma of snoring creates upper airway neuropathy that worsens upper airway stability.” Nelson B. Powell, MD, DDS, a clinical professor of Sleep Medicine at Stanford University, is a pioneer of sleep surgery and sleep research who will speak on a new area of research using computational fluid dynamics to understand airflow and its interactions with the airway in normal and sleep apnea patients. “[Dr. Powell] ultimately may inform us on important anatomical targets and approaches for surgical treatment,” Dr. Weaver said. “Innovations in surgical treatment of OSA include modification and refinements of existing techniques, topics covered in instruction courses annually at the AAO-HNSF meeting. Promising new innovations also include using new technologies, new approaches, and newly invented devices to address upper airway collapse during sleep.” Dr. Weaver said robotic approaches for pharyngeal surgery are being tested for OSA, and early data on this approach will be presented, along with three hypoglossal nerve stimulation devices, which are in various stages of human testing and show early promise as a tool to treat tongue-base obstruction in OSA. “A review of the latest available data for this approach will be presented,” he said. “Other new devices and approaches will also be covered, some with more data than others. Thus, this miniseminar serves to review data on the latest cutting edge technologies used to treat OSA surgically, and it complements the two other miniseminars proposed as part of the Basic & Translational Research Mini-Program on OSA.” The third, and last, miniseminar will discuss recently published reviews of sleep surgery that focus on sleep testing outcomes, review data on sleep surgery outcomes and present new data on cost-effectiveness of sleep surgery. “Several reviews and guidelines for the treatment of OSA have been published in the last few years,” Dr. Weaver said. “The reviews and criticisms of surgical treatment outcomes have focused largely on inadequate cure rates of OSA as measured by the apnea-hypopnea index. This miniseminar reviews the state of the sleep surgery literature and policy, and it looks forward to data and models that may help dictate future policy for the role of sleep surgery.” Looking Ahead According to Dr. Weaver, integration of services is the next breakthrough for sleep medicine, incorporating multiple specialties—primary care, sleep specialists, and related subspecialists—to manage sleep disorders more comprehensively. “It will incorporate multiple approaches, such as with OCST and in-lab polysomnography, to optimize treatment outcomes and maximize cost-effectiveness,” he said. “It will incentivize treatment outcomes rather than simply treatment volume, and it will include a chronic disease management model, where follow-up is key and clinical outcomes guide protocols and policy.” And while no silver bullets are available to cure sleep apnea, Dr. Weaver said there are a number of new technologies that might offer additional approaches to sleep apnea patients. “Hypoglossal nerve stimulators are being tested and appear to hold promise, and robotic surgery is gaining attention and may offer advantages for tongue reduction surgery, especially as the robotic tools improve,” he said. “One of the major challenges for surgical treatment of sleep apnea is to be able to understand the sites of obstruction and the effects on airflow—normal and abnormal—on the tissues. One promising research technology—computer modeling of the airway and airflow to understand sites of obstruction and effects of impaired airflow—is just emerging for sleep apnea, but may hold promise for future clinical application.” This year will see the completion of a five year study looking at the efficacy of T&A for OSA in children. The Childhood Adenotonsillectomy (CHAT) study is an NIH/ NHLBI-sponsored study of 500 children with mild-to-moderate OSA in six clinical sites who were randomized to T&A or watchful waiting. “This is the largest study to date looking at the surgical efficacy of T&A in children with OSA,” said Ron Mitchell, MD, one of the site PIs for the study. “We are excited to be able to analyze the data and plan more clinical studies in the future.”
As the nation grows older and more obese, out-of-center sleep testing (OCST) is keeping the Sleep Disorders Committee of the American Academy of Otolaryngology—Head and Neck Surgery up at night.
Portable monitoring, home sleep testing, and ambulatory sleep testing for obstructive sleep apnea (OSA) are influencing the payment structure, with insurer spending on the procedure under government scrutiny. According to the Office of the Inspector General in the Department of Health and Human Services, Medicare spending on sleep testing increased nearly 280 percent from 2001 to 2009—from $62 million to $235 million.
The problem for physicians, said Edward M. Weaver, MD, MPH, associate professor and chief of sleep surgery in the department of otolaryngology—head and neck surgery at the University of Washington in Seattle, is that insurers are pushing for in-home testing using a portable device in lieu of the more expensive, overnight sleep lab option.
“Some health plans now require OCST for suspected sleep apnea, and probably more plans will require it in the future,” Dr. Weaver said. “This change alters the landscape of reimbursement for sleep medicine, because polysomnography costs and reimburses much more than OCST. In-lab testing has been the major source of revenue for most sleep medicine programs.”
Academy Sleep Disorders Committee Chair Pell Ann Wardrop, MD, medical director of the St. Joseph Hospital’s Sleep Wellness Center in Lexington, KY, said that she sees one insurer’s new policy for sleep testing as a good example of the problem.
“In a couple of geographic areas, the insurer has initiated a new program that requires patients be tested with a home sleep test unless these patients have specific co-morbid conditions,” Dr. Wardrop said. “That is fine in some cases, but many times the patients receive the instructions by mail, and even if that is not the case, the physician cannot individualize the test for the particular patient. Right now the Academy is working to advocate for payment for surgical sleep procedures and access to a variety of treatment options for sleep patients in both Massachusetts and New York, as well as a couple other areas of the country.”
Dovetailing with the sleep center controversy is the growing interest in outcomes-based care, Dr. Weaver said.
“Models of care are being considered where reimbursement and coverage of services are determined by outcome, not just service provided,” he said. “For example, Medicare will cover a continuous positive airway pressure (CPAP) device only if the patient demonstrates adequate use during the initial trial period. Medicare defines adequate use—objectively measured by the CPAP device—as an average of four hours per night on 70 percent of nights during a consecutive 30-day period within the first 90 days of the CPAP trial.”
Both issues may have downstream effects on the practice of sleep surgery, as more OCST may provide easier access for patients to be diagnosed with OSA and increase the need for sleep surgery, Dr. Weaver said.
“Some speculate these patients will not receive as thorough a trial of CPAP, which may translate to a higher rate of failed CPAP patients, which in turn would further increase the downstream need for sleep surgery,” he said. “Likewise, greater scrutiny for CPAP coverage will likely identify CPAP failures more readily and may result in more patients being referred for surgical treatment alternatives to CPAP. One of the challenges for otolaryngology is to have a sufficient number of surgeons trained adequately in the surgical treatment of sleep apnea.”
Education
According to Dr. Wardrop, the Sleep Disorders Committee has spent the last year and a half updating the bulk of the patient education material related to sleep disorders on the AAO-HNS website.
“We have also updated many of the sleep-related clinical indicators and policy statements as part of (AAO-HNS President) Rodney P. Lusk, MD’s, Web Content Relevancy Project—an Academy-wide push to index everything and make our search functions work better.”
Dr. Wardrop said the members of the committee have also developed several soon-to-be-released AcademyU® sleep-related modules, and are also working collaboratively with other committees and societies on quality issues and payment/access to care issues.
“We are also involved in the research arena,” she said. “The committee identified several areas in which there was a paucity of clinical data. Based upon these discussions, Kathleen Yaremchuk, MD, and Andrew J. Senchak, MD, are both leading studies investigating the effect of tonsillectomy in adult OSA.”
It is important to recognize that sleep-disordered breathing and OSA are increasingly diagnosed in children, said Ron Mitchell, MD, professor of Otolaryngology and Pediatrics at UT Southwestern Medical Center, Dallas and chief of pediatric otolaryngology at Children’s Medical Center Dallas. This reflects the recognition that OSA affects up to 2 percent of normal-weight, and 20 percent of overweight and obese children. Adenotonsillectomy (T&A) is the first line surgical treatment for OSA in children with more than 500,000 procedures performed annually in the United States. There is an ongoing debate about indications for polysomnography (sleep studies) prior to T&A for OSA in children. The AAO-HNSF published a guideline in 2011 on polysomnography for sleep-disordered breathing prior to tonsillectomy in children (http://oto.sagepub.com/content/145/1_suppl/S1). It consists of five evidence-based action statements that deal with indications for polysomnography, the need to advocate for polysomnography in certain groups of children, the need to communicate the results of polysomnography with the anesthesiologist, indication for admission to hospital after T&A, and the need to obtain full-night polysomnography instead of portable monitoring to diagnose and quantify OSA. The purpose of the guidelines is to define actions that could be taken by otolaryngologists to deliver quality care, Dr. Mitchell said.
Annual Meeting Research Track
This year’s Translational Research Mini-Program at the AAO-HNSF 2012 Annual Meeting & OTO EXPO in Washington, D.C., will continue the focus on sleep. Dr. Weaver, the Mini-Program chair, said the committee that put the event together sought to cover a broad spectrum of topics relevant to sleep apnea and surgical treatment, with a focus on research topics and data. The topics range from basic science relevant to understanding the upper airway pathology (miniseminar No. 1), to data on emerging surgical treatments (miniseminar No. 2), to research that influences policies relevant to sleep surgery (miniseminar No. 3).
“This Mini-Program will highlight major advances in the field of sleep apnea research relevant to surgery, and it will point to important areas in need of deeper understanding at each level from bench to policy development,” Dr. Weaver said. “We targeted speakers known to give engaging presentations.”
Dr. Weaver said the committee chose speakers who have received “excellent audience feedback” in regard to their respective topics.
“The guest speakers are leaders in the field of sleep medicine,” he said. “Allan Pack, MD, PhD, director of the division of sleep medicine at the University of Pennsylvania, will give the Neel Lecture on the genetics of obstructive sleep apnea. He is a world-renowned expert in the field and a dynamic speaker.”
The 2012 Neel Distinguished Research Lecture will overview genetics in the context of OSA, sharing both experience and data from a large genetics study Dr. Pack is leading in Iceland, an area that provides unique advantages for genetics studies.
“The Icelandic population was in isolation for centuries, so it has a relatively homogeneous gene pool, which helps for gene studies,” Dr. Weaver said. “Moreover, the population is highly supportive of gene studies, so more than half the population has provided material for complete genotyping. With a close collaboration with the sleep medicine program in Iceland—where a large number of patients have been thoroughly phenotyped for OSA, including polysomnography, airway MRI, and other anatomical and physiological measures—the data provide a unique opportunity to study genetic influences on OSA.”
Atul Malhotra, MD, director of the Sleep Program at Harvard’s Brigham & Women’s Hospital and an international leader on normal upper airway physiology and sleep apnea airway pathophysiology, will be featured in the basic science miniseminar.
“While otolaryngologists are expert in assessing the anatomical features of the upper airway, the physiological basis of upper airway collapse during sleep is not as well understood by most otolaryngologists,” Dr. Weaver said. “This miniseminar will highlight a world expert on physiological upper airway dynamics and how it relates to OSA. An intriguing pathophysiologic theory about OSA is that vibration trauma of snoring creates upper airway neuropathy that worsens upper airway stability.”
Nelson B. Powell, MD, DDS, a clinical professor of Sleep Medicine at Stanford University, is a pioneer of sleep surgery and sleep research who will speak on a new area of research using computational fluid dynamics to understand airflow and its interactions with the airway in normal and sleep apnea patients.
“[Dr. Powell] ultimately may inform us on important anatomical targets and approaches for surgical treatment,” Dr. Weaver said. “Innovations in surgical treatment of OSA include modification and refinements of existing techniques, topics covered in instruction courses annually at the AAO-HNSF meeting. Promising new innovations also include using new technologies, new approaches, and newly invented devices to address upper airway collapse during sleep.”
Dr. Weaver said robotic approaches for pharyngeal surgery are being tested for OSA, and early data on this approach will be presented, along with three hypoglossal nerve stimulation devices, which are in various stages of human testing and show early promise as a tool to treat tongue-base obstruction in OSA.
“A review of the latest available data for this approach will be presented,” he said. “Other new devices and approaches will also be covered, some with more data than others. Thus, this miniseminar serves to review data on the latest cutting edge technologies used to treat OSA surgically, and it complements the two other miniseminars proposed as part of the Basic & Translational Research Mini-Program on OSA.”
The third, and last, miniseminar will discuss recently published reviews of sleep surgery that focus on sleep testing outcomes, review data on sleep surgery outcomes and present new data on cost-effectiveness of sleep surgery.
“Several reviews and guidelines for the treatment of OSA have been published in the last few years,” Dr. Weaver said. “The reviews and criticisms of surgical treatment outcomes have focused largely on inadequate cure rates of OSA as measured by the apnea-hypopnea index. This miniseminar reviews the state of the sleep surgery literature and policy, and it looks forward to data and models that may help dictate future policy for the role of sleep surgery.”
Looking Ahead
According to Dr. Weaver, integration of services is the next breakthrough for sleep medicine, incorporating multiple specialties—primary care, sleep specialists, and related subspecialists—to manage sleep disorders more comprehensively.
“It will incorporate multiple approaches, such as with OCST and in-lab polysomnography, to optimize treatment outcomes and maximize cost-effectiveness,” he said. “It will incentivize treatment outcomes rather than simply treatment volume, and it will include a chronic disease management model, where follow-up is key and clinical outcomes guide protocols and policy.”
And while no silver bullets are available to cure sleep apnea, Dr. Weaver said there are a number of new technologies that might offer additional approaches to sleep apnea patients.
“Hypoglossal nerve stimulators are being tested and appear to hold promise, and robotic surgery is gaining attention and may offer advantages for tongue reduction surgery, especially as the robotic tools improve,” he said. “One of the major challenges for surgical treatment of sleep apnea is to be able to understand the sites of obstruction and the effects on airflow—normal and abnormal—on the tissues. One promising research technology—computer modeling of the airway and airflow to understand sites of obstruction and effects of impaired airflow—is just emerging for sleep apnea, but may hold promise for future clinical application.”
This year will see the completion of a five year study looking at the efficacy of T&A for OSA in children. The Childhood Adenotonsillectomy (CHAT) study is an NIH/ NHLBI-sponsored study of 500 children with mild-to-moderate OSA in six clinical sites who were randomized to T&A or watchful waiting. “This is the largest study to date looking at the surgical efficacy of T&A in children with OSA,” said Ron Mitchell, MD, one of the site PIs for the study. “We are excited to be able to analyze the data and plan more clinical studies in the future.”