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Challenges to the Current Practice of Sleep Medicine
Nancy Collop, MD
Professor of Medicine
Johns Hopkins University
OutlineReimbursement
PSG Limited channel diagnostics
(Wo)Manpower Technologists Physicians Other providers
The Sleep Lab of the Future
Reimbursement for Diagnostic TestingCPT (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)
Reimbursement for Diagnostic TestingCPT Categories
Category I – procedure or service which is consistent with contemporary medical practices and being currently performed in multiple locations
Category II – performance measurementCategory III – emerging technology
CPT Codes – Sleep Related
95803 Actigraphy testing95805 MSLT95806 Sleep study, unattended95807 Sleep study, attended95808 PSG, 1-395810 PSG, 4 or more95811 PSG, w/CPAP94660 Pos airway pressure, CPAP
95806 – Unattended PMOriginal: 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 (eg thoracoabdominal 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
HCPCS G0398-G0400 (G Codes)
CMS derived codes for unattended portable monitoring
1. G-0398, Type II device recording 7 channels a) Unattended polysomnography
b) $100 is recognized for the Professional Component - $50 is recognized for the Technical Component
2. G0399, Type III device (same as CPT Code 96806)a) - $85 is recognized for the Professional Component
- $35 is recognized for the Technical Component
3. G0400, Type IV test that measures 3 channelsa) Channels to be measured are not specified
b) $70 is recognized for the Professional Component - $30 is recognized for the Technical Component
$150
$120
$100
Polysomnography Growth (Medicare)
1999 2001 2002 2003 2004 20080
100000
200000
300000
400000
500000
600000
9581095811
RUC (RVS Update Committee)AMA and Specialty Societies
Recommends RVU’s (relative value units) for CPT codesEvaluates 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
Current Re-evaluation of Sleep CodesConsider new codes
Pediatric polysomnographyPolysomnography with extended EEG leadsSplit night study
Update old codesLimited channel studiesPSG
Survey
BUDGET NEUTRALITY
ONE POT OF FUNDS
ONE SPECIALTY GAINS, ANOTHER MUST LOSE
WOULD NOT EXPECT AN INCREASE!!
Limited Channel TestingWhat is the right term?
Portable monitoringHome sleep testingCardio-respiratory testingLimited channel testing
How should it be used?ScreeningStandard of careAlgorithmic approach
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.
CAG # 00405N (3/9/09)Sleep Testing for Obstructive Sleep Apnea
Therefore: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.
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.
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 tone 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.
“CMS finds that the evidence is sufficient…”Whitelaw et alAm J Respir Crit Care Med 2005;171:188-93
Mulgrew et alAnn Intern Med 2007;146:157-166
Prospective observational (4 wks)
288 patients randomized to PSG or LCT (Snoresat)
All seen by sleep physicians4767 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
Limited Channel TestingARES
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
ChallengesWhich one?
Channels (# and type)Easy of attachment/instructionsAutomated scoringCost
Disposables Breakage Postage and shipping
Which pts are appropriate?
ARES
Lifesh
irt
ApneaLink ►◄ Trakit
MediByte
SleepTrek3
WatchPat200
ApneaGraph
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)
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)
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 PMIncluding but not limited to:
moderate to severe pulmonary diseaseneuromuscular diseasecongestive heart failure
JCSM 2007 Vol 3(7)
Other Sleep Disorders PM is not appropriate for the diagnostic
evaluation of OSA in patients suspected of having other sleep disorders
Central sleep apneaPeriodic limb movement disorder (PLMD)InsomniaParasomniasCircadian rhythm disordersNarcolepsy
JCSM 2007 Vol 3(7)
Not for General Screening
PM is not appropriate for general screening of asymptomatic populations
JCSM 2007 Vol 3(7)
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)
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)
May 21, 200927
Patient presents to BCSS for eval. of suspected OSA
Does the patient have a high pretest
probability of moderate to severe
OSA?
Does the patient have symptoms or signs of co-morbid medical disorders?
Does patient have symptoms or signs for co-morbid sleep
disorders?
Evaluate for other sleep disorders;
consider in lab PSG
Sleep Study(PM or in-lab PSG)
PM
In-lab PSG OSA Diagnosed?
Treatment
No
No
No
No
Yes
Yes
Yes
Yes
No
Portable Monitoring Decision Tree
JCSM 2007 Vol 3(7)
Limited Channel TestingWho should be doing it?
PCP’sENT’sDentistsSleep specialists
What device?Which patients?What cutoffs?How do you initiate treatment?Will you get PAID?? How much??
Treatment After LCTSplit night titration
Confirm diagnosis, initiate treatmentStill need sleep lab
CPAP titrationStill need sleep lab
AutoPAP2 weeks then fixedContinuous
CPAP guesstimate (what the heck, half the neck?)
DOES IT REALLY MATTER??
30
Algorithm for PAP devicesFixed CPAP Auto PAP
Pressure is set based on highest pressure needed to eliminate all sleep disordered breathing eventsApneasHypopneasRERA’sSnoringFlow limitation
AutoPAP analyzes flow (or vibration)
Pressure adjusts (increases) when flow becomes
abnormalPressure falls when flow is
stable for a period of time
31
Comparison of APAP Devices
Farre et al, Am J Respir Crit Care Med 2002;166:469-73
CHEST 2009 32
5 devicesAutoSet TAutoSet SpiritGoodKnight 420EPV10iREMStar Auto
CHEST 2009 33
Bench Study
apnea hypopnea
FLsnoring
CHEST 2009 34
Bench Study
35
AutoPAPAutoCPAP 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……..
(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
Technologist LegislationStates 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
Technologist LegislationStates 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
Technologists Manpower IssuesEducational initiatives have not kept pace with legislative
effortsAASM 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
Physician ManpowerApproximately 3200 are board certified by ABSMApproximately 3800 are board certified by ABMS
Many are bothUnsure of total board certified – probably around 6000
currentlyOne more year of “grandfather waiver”
79 sleep medicine fellowship programs (~125 slots)~1800 AASM accredited sleep centers
Physician ManpowerSleep Apnea
5% of US adult population (217,000,000) = 10,850,0001% of US pediatric population (74,000,000) = 740,000Total = 11,590,000
Insomnia10% of US adult population = 21,7000,000
Restless Legs SyndromeEstimate affects 12,000,000
TOTAL = 45,290,000 / 6000 BCSS = 7550 New Pts/yr
Physician ManpowerBeyond clinical needs, important research needs
1 year sleep fellowship “discourages” researchAcademic sleep programs must encourage sleep researchDevelop 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)
PsychologistsInsomnia afflicts 10-30% of US populationHypnotic therapy is a poor long term solutionCognitive behavioral therapy for insomnia has a proven
track record and long term effectivenessAASM had offered certification test in Behavioral Sleep
Medicine (BSM)ABSM has taken over the exam for 2010
Currently ~ 200 BSM certified21,700,000 / 200 BSMC = 108,500 New Pts/year !!!
PsychologistsDebate 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 backgroundUnmet 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
THE LAW LCT
Reimbursement
Aging and heavier
population
Wo/Manpower
Sleep Center
of the Future
How to position your sleep centerInvestigate ways to reduce PSG costs
Scoring on the flyIncrease split night studiesClosely 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, RLSDistribute your own DMECreat a LCT program
How to position your sleep centerDevelop new programs
Offer CBT-I Online or self study programs Group therapy
ActigraphyOn line consultationsExecutive Health/Wellness programs
Use physician extenders CPAP clinicMedical HomeCBT-I
Other ChallengesAttracting the “best and brightest” to the field
More teaching in medical schoolElectives for housestaff (neurology, internal medicine,
psychiatry, family medicine, ENT)Nimble accreditation standardsDeveloping chronic disease management strategies for the
complex variety of sleep disordersMedical home
Utilizing the electronic medical record
Other ChallengesResearch 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
Questions??Thanks to Gerald Rich and Sam Fleishman for CPT/RUC
slidesThanks to Larry Epstein and the NESS for inviting me!
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