Challenges to the Current Practice of Sleep Medicine

1. Challenges to the Current Practice of Sleep Medicine Nancy Collop, MD Professor of Medicine Johns Hopkins University

2. Outline • Reimbursement • PSG • Limited channel diagnostics • (Wo)Manpower • Technologists • Physicians • Other providers • The Sleep Lab of the Future

3. Reimbursement for Diagnostic Testing • CPT (Current Procedural Terminology) • Widely accepted medical nomenclature to report medical procedures and services • Used by CMS and insurance companies for coding and describing health care services • The AMA is responsible for maintenance (CPT Editorial Panel)

4. Reimbursement for Diagnostic Testing • CPT Categories • Category I – procedure or service which is consistent with contemporary medical practices and being currently performed in multiple locations • Category II – performance measurement • Category III – emerging technology

5. CPT Codes – Sleep Related

6. 95806 – Unattended PM • Original: Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart rate, and oxygen saturation, unattended by a technologist • New: Sleep study, simultaneous recording of heart rate, oxygen saturation, respiratory airflow, and respiratory effort (egthoracoabdominal movement) unattended by a technologist • Added 2 Category III codes (T codes): • 0203T: Sleep study, simultaneous recording of heart rate, oxygen saturation, respiratory analysis (eg airflow or peripheral arterial tone) and sleep time, unattended by a technologist • 0204T: Sleep study, simultaneous recording of heart rate, oxygen saturation, respiratory analysis (eg airflow or peripheral arterial tone) unattended by a technologist

7. HCPCS G0398-G0400 (G Codes) $150 $120 $100 CMS derived codes for unattended portable monitoring • G-0398, Type II device recording 7 channels • Unattended polysomnography • $100 is recognized for the Professional Component      - $50 is recognized for the Technical Component • G0399, Type III device (same as CPT Code 96806) • - $85 is recognized for the Professional Component      - $35 is recognized for the Technical Component • G0400, Type IV test that measures 3 channels • Channels to be measured are not specified  • $70 is recognized for the Professional Component      - $30 is recognized for the Technical Component

8. Polysomnography Growth (Medicare)

9. RUC (RVS Update Committee) • AMA and Specialty Societies • Recommends RVU’s (relative value units) for CPT codes • Evaluates cost of providing the service • Physician work • Time to perform • Technical skill and physical effort • Mental effort and judgement • Patient risk • Practice expense • Direct (clinical labor, equipment, supplies) • Indirect (rent, utilities, etc) • Malpractice expense

10. Current Re-evaluation of Sleep Codes • Consider new codes • Pediatric polysomnography • Polysomnography with extended EEG leads • Split night study • Update old codes • Limited channel studies • PSG • Survey

11. BUDGET NEUTRALITY • ONE POT OF FUNDS • ONE SPECIALTY GAINS, ANOTHER MUST LOSE • WOULD NOT EXPECT AN INCREASE!!

12. Limited Channel Testing • What is the right term? • Portable monitoring • Home sleep testing • Cardio-respiratory testing • Limited channel testing • How should it be used? • Screening • Standard of care • Algorithmic approach

13. CAG # 00405N (3/9/09)Sleep Testing for Obstructive Sleep Apnea CMS finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA, that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment, and that these tests are thus reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. Therefore: • 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.

14. CAG # 00405N (3/9/09)Sleep Testing for Obstructive Sleep Apnea Therefore: • A Type II or a Type III sleep testing deviceis 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. • 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 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.

15. CAG # 00405N (3/9/09)Sleep Testing for Obstructive Sleep Apnea Therefore: • A sleep testing device measuring three or more channels that include actigraphy, oximetry, and peripheral arterial toneis covered when used to aid the diagnosis of 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.

16. “CMS finds that the evidence is sufficient…” Whitelaw et al Am J RespirCrit Care Med 2005;171:188-93 Mulgrew et al Ann Intern Med 2007;146:157-166 • Prospective observational (4 wks) • 288 patients randomized to PSG or LCT (Snoresat) • All seen by sleep physicians • 4767 referrals received, 44% considered “eligible” ; of those 288 (11%) completed the trial • No difference in CPAP compliance • No difference in ESS, RDI on treatment, SAQLI scores or SF36 domains between groups • Randomized Controlled Open Label (3 months) • 68 pts randomized to PSG or LCT (Remmers Sleep Recorder) • 2216 were referred, 2135 were excluded, 61 pts finished protocol • High probability patients (ESS > 10; SACS score > 15; RDI > 15) • Compliance better in ambulatory group (6.0 vs 5.4 hrs) • No difference in AHI on CPAP after 3 months; ESS, SAQLI, CPAP levels

17. Limited Channel Testing ARES LifeShirt ApneaLink/ApneaLink Plus Stardust II/Alice PDX Trackit 18+8/Trackit Sleep Walker Nomad Trex WatchPAT200 SleepTrek3 Embletta Gold Somte/Somte PSG SleepScout Easy Ambulatory PSG MediPalm MediByte/MediByte Jr SNAP ApneaGraph • Challenges • Which one? • Channels (# and type) • Easy of attachment/instructions • Automated scoring • Cost • Disposables • Breakage • Postage and shipping • Which pts are appropriate? ARES WatchPat200 Lifeshirt SleepTrek3 MediByte ApneaGraph Stardust ◄ Trakit ApneaLink ►

18. PM as Part of a Comprehensive Evaluation For the diagnosis of OSA, PM should be performed only in conjunction with a comprehensive sleep evaluation • Clinical sleep evaluations using PM must be supervised by a practitioner with board certification in sleep medicine or an individual who fulfills the eligibility criteria for the sleep medicine certification examination • In the absence of a comprehensive sleep evaluation, there is no indication for the use of PM JCSM 2007 Vol 3(7)

19. Limited Use to Pts with high pre-test probability of OSA PM may be used as an alternative to polysomnography for the diagnosis of OSA in patients with a high pre-test probability of moderate to severe OSA • This is true only if the recommendations of 1.1 (comprehensive evaluation) have been satisfied • PM should not be used in the patient groups with co-morbidities, other sleep disorders or for screening JCSM 2007 Vol 3(7)

20. Co-morbid Medical Conditions PM is not appropriate for the diagnosis of OSA in patients with significant co-morbid medical conditions • degrade the accuracy of PM • Including but not limited to: • moderate to severe pulmonary disease • neuromuscular disease • congestive heart failure JCSM 2007 Vol 3(7)

21. Other Sleep Disorders PM is not appropriate for the diagnostic evaluation of OSA in patients suspected of having other sleep disorders • Central sleep apnea • Periodic limb movement disorder (PLMD) • Insomnia • Parasomnias • Circadian rhythm disorders • Narcolepsy JCSM 2007 Vol 3(7)

22. Not for General Screening PM is not appropriate for general screening of asymptomatic populations JCSM 2007 Vol 3(7)

23. Follow-up A follow-up visit with a physician or other appropriately trained and supervised health care provider should be performed on all patients undergoing PM to discuss the results of the test JCSM 2007 Vol 3(7)

24. Negative PM Studies Due to the known rate of false negative PM tests, in laboratory PSG should be performed in cases where PM is technically inadequate or fails to establish the diagnosis of OSA in patients with a high pretest probability JCSM 2007 Vol 3(7)

25. Treatment Patient presents to BCSS for eval. of suspected OSA Portable Monitoring Decision Tree Does the patient have a high pretest probability of moderate to severe OSA? Evaluate for other sleep disorders; consider in lab PSG No No Yes Yes Does the patient have symptoms or signs of co-morbid medical disorders? OSA Diagnosed? In-lab PSG Yes No Does patient have symptoms or signs for co-morbid sleep disorders? Yes No PM Sleep Study (PM or in-lab PSG) No 27 JCSM 2007 Vol 3(7)

26. Limited Channel Testing • Who should be doing it? • PCP’s • ENT’s • Dentists • Sleep specialists • What device? • Which patients? • What cutoffs? • How do you initiate treatment? • Will you get PAID?? How much??

27. Treatment After LCT • Split night titration • Confirm diagnosis, initiate treatment • Still need sleep lab • CPAP titration • Still need sleep lab • AutoPAP • 2 weeks then fixed • Continuous • CPAP guesstimate (what the heck, half the neck?) • DOES IT REALLY MATTER??

28. Algorithm for PAP devices Fixed CPAP Auto PAP • Pressure is set based on highest pressure needed to eliminate all sleep disordered breathing events • Apneas • Hypopneas • RERA’s • Snoring • Flow limitation • AutoPAP analyzes flow (or vibration) • Pressure adjusts (increases) when flow becomes abnormal • Pressure falls when flow is stable for a period of time

29. Comparison of APAP Devices Farre et al, Am J Respir Crit Care Med 2002;166:469-73

30. 5 devices • AutoSet T • AutoSet Spirit • GoodKnight 420E • PV10i • REMStar Auto CHEST 2009

31. Bench Study apnea hypopnea snoring FL CHEST 2009

32. Bench Study CHEST 2009

33. AutoPAP • AutoCPAP technology appears to be as effective as (not superior to) conventional CPAP technology for treating OSA with regards to improvements in AHI and daytime sleepiness – short term studies • There are significant differences between auto-titrating devices • Autotitrating PAP have to react to abnormal flow – perhaps there are more subtle long term differences that are as yet undiscovered……..

34. (Wo)Manpower: Technologist Legislation • Before 2000, no formal programs or legislation existed regarding the practice of polysomnography • In some states, respiratory therapy began to demand enforcement of licensing that only RT’s could administer CPAP and oxygen • This prompted a movement to develop licensure for sleep techs • Licensure also spawned a movement to developing standardized training programs for techs

35. Technologist Legislation • States with a Polysomnography Practice Act: • California, Louisiana, Maryland, New Jersey, New Mexico, North Carolina, Tennessee, and Washington D.C • States with exemption language in their respective Respiratory Care Act (31): • AL, AZ, AR, CO, GA, IL, IN, IA, KS, ME, MA, MI, MN, MS, MO, NE, NH, NV, OH, OK, PA, SC, SD, TX, UT, VT, VA, WA, WV, WI, WY • States which specifically define polysomnographic technology and their scope of practice in Respiratory Care Acts: • Idaho and North Dakota

36. Technologist Legislation • States which contain a Respiratory Care Act that does not address the practice of polysomnography (8): • CT, DE, FL, KY, MT, NY, OR, RI • States with no language pertaining to respiratory therapy or to polysomnographic technology: • Hawaii and Alaska

38. Technologists Manpower Issues • Educational initiatives have not kept pace with legislative efforts • AASM launched ASTEP (Accredited Sleep Technologists Educational Program) – BRPT began requiring it for some of the pathways to sit for the registry exam • Required: Pathway #1 (18 months of PSG experience plus secondary education) and Pathway #4 (9 months of PSG experience) • Not required: Pathway #2 (6 months of PSG experience with an Allied Health Credential) and Pathway #3 (graduates of a CoA-PSG, or an add-on program under sleep technology program under CoA-END or CoA-RC) • CAAHEP approved polysomnography technologist program • Currently only 26 approved CoA-PSG programs

39. Physician Manpower • Approximately 3200 are board certified by ABSM • Approximately 3800 are board certified by ABMS • Many are both • Unsure of total board certified – probably around 6000 currently • One more year of “grandfather waiver” • 79 sleep medicine fellowship programs (~125 slots) • ~1800 AASM accredited sleep centers

40. Physician Manpower • Sleep Apnea • 5% of US adult population (217,000,000) = 10,850,000 • 1% of US pediatric population (74,000,000) = 740,000 • Total = 11,590,000 • Insomnia • 10% of US adult population = 21,7000,000 • Restless Legs Syndrome • Estimate affects 12,000,000 • TOTAL = 45,290,000 / 6000 BCSS = 7550 New Pts/yr

41. Physician Manpower • Beyond clinical needs, important research needs • 1 year sleep fellowship “discourages” research • Academic sleep programs must encourage sleep research • Develop funding mechanisms for fellow research • T-32 grants (3-5 in the country for sleep – Penn, Pitt, Harvard, NW) • ASMF grants • Other NIH (NRSA, etc)

42. Psychologists • Insomnia afflicts 10-30% of US population • Hypnotic therapy is a poor long term solution • Cognitive behavioral therapy for insomnia has a proven track record and long term effectiveness • AASM had offered certification test in Behavioral Sleep Medicine (BSM) • ABSM has taken over the exam for 2010 • Currently ~ 200 BSM certified • 21,700,000 / 200 BSMC = 108,500 New Pts/year !!!

43. Psychologists • Debate exists about training masters level practitioners • Some PhD’s do not think this is appropriate – need enough background to properly diagnose and initiate CBT-I • New exam is limited to PhD’s with health care background • Unmet need being met with novel online programs, group therapy, physician managed, self help (MP3 downloads, books, CD/DVD’s) • Little research on effectiveness of these alternate approaches

44. Wo/Manpower THE LAW LCT Aging and heavier population Reimbursement

45. Sleep Center of the Future

46. How to position your sleep center • Investigate ways to reduce PSG costs • Scoring on the fly • Increase split night studies • Closely examine your costs (tech:patient ratio, use of auto-titrating devices in the lab, remote monitoring) • Develop a comprehensive program • Chronic care model for OSA, insomnia, RLS • Distribute your own DME • Creat a LCT program

47. How to position your sleep center • Develop new programs • Offer CBT-I • Online or self study programs • Group therapy • Actigraphy • On line consultations • Executive Health/Wellness programs • Use physician extenders • CPAP clinic • Medical Home • CBT-I

48. Other Challenges • Attracting the “best and brightest” to the field • More teaching in medical school • Electives for housestaff (neurology, internal medicine, psychiatry, family medicine, ENT) • Nimble accreditation standards • Developing chronic disease management strategies for the complex variety of sleep disorders • Medical home • Utilizing the electronic medical record

49. Other Challenges • Research and development of new therapies • Do you believe we are still using CPAP?? • CPAP use may stunt new research development • Allows us to not consider cause of apnea • Comfortable in prescribing it (cheap, low side effect profile, widely accepted) • Insomnia therapies • Drugs are short term solution • Need better characterization of causes (brain chemistry) • Hypersomnia therapy • 2 categories of “stimulating” agents • Need better characterization of causes • Hypocretin discovery – major breakthrough