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!