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In-Home Sleep Testing: Is It a Sleeper?

Nicholas J. Macmillan is the National Clinical Director for Rotech Healthcare, Inc. and owns and operates Outside the Box Consulting, a health care consulting firm. Nick has been involved in health care for over twenty five years as a registered respiratory therapist (RRT), manager and executive. He has worked in acute care, emergency care, intensive care, neonatal intensive care, cardiopulmonary diagnostics and rehabilitation, sub-acute care, home care, manufacturing and respiratory, nursing and community education. Over the last fifteen years Nick’s home care positions have included Global Sleep Product Director, Director of Respiratory Care and New Business Development, Vice President of HME Operations and Corporate Compliance Officer. He has held several state and national appointments and elected positions, including the President of the Indiana Society for Respiratory Care, Chairperson for the Home Care Section of the American Association for Respiratory Care and member of AAHomecare’s HME/RT Council. Nick was inducted as a Fellow of the American Association for Respiratory Care in 2003. Nick has been invited to present on a variety of topics at state, regional and national conferences. In addition, he has been published in several trade and related journals.

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In-Home Sleep Testing: Is It a Sleeper?

Objective:Update on the current status of in-home sleep testing from both a regulatory and reimbursement perspective.

Review of recent developments in sleep home diagnosticsDiscuss real world activities and strategies for preparedness

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Stirring the Home Sleep Study Pot An international conference on home sleep testing sponsored by the

American College of Chest Physicians was held in Chicago in September 2000 (Use of Home Monitors for the Diagnosis of Sleep Apnea). As an outgrowth of this conference, the American College of Chest

Physicians (ACCP), the American Thoracic Society (ATS), and the American Academy of Sleep Medicine (AASM) entered into a collaborative project to evaluate the current literature and develop a guideline on portable monitoring to diagnosis OSA.

Executive Summary of the American Thoracic Society, the American College of Chest Physicians, and the American Association of Sleep Medicine, October2003

CMS and home studies Initial inquiry in April 2004

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Definitions: Diagnostic Devices Type 1 standard PSG is currently standard of care Type 2 portable monitoring (PM) devices: minimum of seven

channels, including electroencephalogram (EEG), electrooculogram (EOG), chin electromyogram (EMG), electrocardiogram (ECG) or heart rate, airflow, respiratory effort, oxygen saturation

Type 3 PM devices: minimum of four channels, including ventilation or airflow (at least two channels of respiratory movement, or respiratory movement and airflow), heart rate or electrocardiogram and oxygen saturation

Type 4 PM devices: most monitors of this type measure a single parameter or two parameters

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ATS Executive Summary Evidence-based approach

Extensive literature review Research questions developed

1. Can portable monitoring rule out obstructive sleep apnea?2. Can portable monitoring rule in obstructive sleep apnea?3. Can portable monitoring both rule out and rule in obstructive sleep apnea?Secondary research questions1. What is the reproducibility of portable monitor results?2. What is the cost benefit of testing with portable monitors?3. What are the failure rates of testing with portable monitors?4. What patient populations were studied?

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ATS Executive Summary Results LEVELS OF RECOMMENDATIONS: Term Definition

Standard: This is a generally accepted patient care strategy that reflects a high degree of clinical certainty. The term standard generally implies the use of Level I evidence, which directly addresses the clinical issue, or overwhelming Level II evidence

Guideline: This is a patient care strategy that reflects a moderate degree of clinical certainty. The term guideline implies the use of Level II evidence or a consensus of Level III evidence

Option: This is a patient care strategy that reflects uncertain clinical use. The term option implies either inconclusive or conflicting evidence or conflicting expert opinion

(Adapted from Eddy: Eddy DM, editor. A manual for assessing health practices and designing practice policies: the explicit approach. Philadelphia: American College of Physicians; 1992.)

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ATS Executive Summary Results Type 2 PMs: Comprehensive Portable Polysomnography Attended setting.

Type 2 PMs are not recommended for clinical use to evaluate patients with sleep apnea. (Option)

Unattended setting. Type 2 PMs are not recommended for clinical use to evaluate

patients with sleep apnea. (Option) Comment. At the time of this evidence-based review, Type

2PMs did not have adequate available data to recommend their clinical use based on the small number of published studies, the absence of sensitivity/specificity data, and the low level of evidence.

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ATS Executive Summary Results TYPE 3 PMs: Modified Portable Sleep Apnea Testing Attended Setting.

Some Type 3 PMs appear capable of being used to decrease the probability that the patient has an AHI15. (Standard)

Some Type 3 PMs appear capable of being used to increase the probability that a patient has an AHI 15. (Standard)

Comment. There appears to be some evidence suggesting that the use of Type 3 PMs may be acceptable in an in-laboratory setting, both to rule in and rule out OSA. (Standard) [with some limitations]

Unattended Setting. Type 3 PMs are not recommended for use to decrease the probability

that the patient has an AHI 15. (Guideline) Type 3 PMs are not recommended for clinical use to increase the

probability that the patient has an AHI 15. (Guideline) Type 3 PMs are not recommended for use to rule in and rule out OSA.

(Guideline)

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ATS Executive Summary Results Type 4 PMs: Continuous Single or Dual Bioparameter

Recording Attended Setting.

Type 4 PMs with oximetry and at least one other airflow parameter are not recommended for routine use to increase the probability that a patient has an AHI 15. (Option)

Type 4 PMs with oximetry and at least one other airflow parameter are not recommended to decrease the probability that that a patient has an AHI 15. (Option)

Type 4 PMs with oximetry and at least one other airflow parameter are not recommended for routine use both to increase and reduce the probability that a patient has an AHI 15. (Option)

Unattended Setting. Type 4 PMs with the utilization of oximetry and at least one other airflow

parameter are not recommended for use in diagnosing sleep apnea or confirming that a patient has an AHI 15 or AHI 15. (Guideline)

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CMS and Home Studies

Initial inquiry April 2004 by Dr. Terrance Davidson

Referred to the Medicare Coverage Advisory Committee

Specific questions

Open comment period Open meeting – September 28th, 2004 Decision Memo: April 2005

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CMS and Home Studies

Explored two devices: Evaluative questions on portable devices that measure the

same sleep and respiratory parameters as facility based polysomnography, i. e. EEG, EOG, EMG, respiratory movement, airflow, oxygen saturation, and heart rate or ECG.

Evaluative questions on portable devices that measure cardiorespiratory parameters only, i. e. respiratory movement, airflow, oxygen saturation, and heart rate or ECG.

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CMS and Home Studies Questions:

Effectiveness Scientific evidence and validity

Acquisition of interpretable data Ability to accurately diagnose OSA (sensitivity) Ability to accurately identify those without OSA

(specificity) Good as or better than facility PSG Accuracy Outcomes Accessibility Generalization to:

General population Medicare population

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CMS and Home Studies Decision:

The evidence is not adequate to conclude that the use of unattended portable multi-channel sleep testing with a minimum of 7 monitored channels including EEG, EOG, EMG, ECG or heart rate, airflow, respiratory effort, and oxygen saturation (Type II Devices based on the 1994 ASDA classification) is reasonable and necessary in the diagnosis of OSA and these tests will remain noncovered for this purpose.

The evidence is not adequate to conclude that the use of unattended portable multi-channel sleep testing with a minimum of 4 monitored channels including ventilation or airflow, heart rate or ECG, and oxygen saturation (Type III Devices based on the 1994 ASDA classification system) is reasonable and necessary in the diagnosis of OSA and these tests will remain noncovered for this purpose

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In-Home Sleep Testing: Is It a Sleeper? What are the drivers:

Financial Costs

Payors Reimbursement

Patient? Out of pocket expenses

Opportunity Medical health care providers Manufacturers

Access What are the requirements:

Technology Validated

Coverage Clinical acceptance

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Real World Drivers: Financial

$1.9 trillion Projected amount of public and private spending for health care in 2005;

that’s 15.4 percent of gross domestic product and averages $6,423 per person.

49 percent Government’s share of funding for all health spending in the U.S. by 2014,

largely due to the new Medicare prescription drug benefit. 7.7 percent

Rate of increase for national health expenditures from 2002 to 2003—four times the rate of inflation

$9,950 Average annual premium a health insurer charged an employer for health

plan coverage for a family of four in 2004. That’s $829 a month. $14,500

Projected average health insurance premiums for family coverage in 2006

Sources: National Coalition on Health Care and Centers for Medicare and Medicaid Services

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25%25% 18%

22% 14%

34% 10%10%

9%

26%

0

100

200

300

400

500

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

# of sleep studies (000s)

U. S. Growth in Sleep StudiesCMS data represents 15% of US market

Real World Drivers: Financial

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Real World Drivers: Financial

$2 Billion current annual market for sleep testing services 1.8MM studies annually $1,200 average MCO reimbursement

$1 Billion current annual market for sleep apnea

therapy devices Sleep labs around the US increased capacity by

24% in 2004 and 36% in 2005

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Real World Drivers: Financial

Sleep study and CPAP reimbursement WellPoint/Anthem $400MM Aetna $350MM United Health $300MM Cigna $150MM Independence Blue Cross $100MM Kaiser $50MM Regents BCBS $50MM CareFirst BCBS of MD $50MM

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Real World Requirements: Technology

Diagnostics - Diagnostic options Research validating performance is old but is

catching up Consolidation

APSS 2003 – 23 diagnostic companies APSS 2004 – 8 diagnostic companies APSS 2005 – 13 diagnostic companies

Increased equipment channels and performance

Increased usage

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Real World Requirements: Coverage CIGNA HealthCare covers portable home sleep studies for the diagnosis of

obstructive sleep apnea (OSA) when BOTH of the following criteria are met: The individual has been evaluated by a physician, and findings are suggestive of

a diagnosis of OSA (e.g., loud snoring, excessive daytime sleepiness, or observed cessation of breathing during sleep).

A level III device (see below) is used. At a minimum the device must have ALL of the following features: ability to record ventilation (at least two channels of respiratory movement, or

respiratory movement and airflow); ECG or heart rate; and oxygen saturation has been validated in a typical home environment

AND ONE OR MORE of the following criteria are met: Patient has severe clinical symptoms that are indicative of OSA, AND initiation of

treatment is urgent, AND standard PSG (polysomnography) is not available. Patient is unable to be studied in a sleep laboratory. For follow-up testing when the diagnosis of OSA has been established by facility-

based PSG and therapy has been initiated

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Real World Requirements: Coverage

A portable, unattended home sleep study may be considered medically necessary when one of the following criteria is met: Severe symptoms requiring immediate treatment and

polysomnography is not available The patient cannot be studied in a sleep laboratory (e.g.,

nonambulatory, severe obesity) For follow-up study to evaluate response to therapy If a certified sleep disorders center is not reasonably

accessible Other circumstance in which a sleep specialist has made the

request and medical policy criteria have been met

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Real World Drivers: Clinical Acceptance

Research required Funding and support

Collaboration rather than confrontation Share existing data

Sleep Solutions Veterans Affairs

Dr. Kuna Costs Access

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Real World Drivers: Clinical Acceptance

Share existing data Medicare hearing

Dr. Coppola 7000 manually scored home sleep studies “Group Health associates have performed over 19,000 portable sleep

recordings and they have a failure rate of 2.8 percent. We in Massachusetts have a failure rate of one percent.”

Dr. David Barone (referring to an evaluation that was done by the Institute for Clinical System Improvements) “First, in patients with high pretest probability of sleep apnea, [emphasis

added] unattended portable recording is an acceptable alternative to standard PSG. They also said, talking about accessibility issues and talking about it stated, employment of portable monitoring as a second best option is not likely to result in harm to patients with high pretest probability of sleep apnea and may result in effect in less risk than leaving the condition undiagnosed.”

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Executive Summary on the Systematic Review andpractice Parameters for Portable Monitoring in theInvestigation of Suspected Sleep Apnea in Adults, October 2003

From a clinical point of view it is important to recognize that evidence-based medicine will always be behind the curve of progress. New ideas generate new technologies and methods of health care delivery. These advances must await the collection and analysis of data before their role can be established with scientific certainty. Today’s option or guideline may become tomorrow’s standard or be rejected on the basis of accumulated evidence. We are fortunate that our pluralistic system of medical care allows room for innovation and simultaneously demands evidence to justify what we do. The clinical demand for tests that investigate possible sleep-disordered breathing is rising. It is apparent from the findings of this report that there is an urgent need for additional high-quality studies to clarify the performance and role of portable monitors in the diagnosis and management of sleep apnea.

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In-Home Sleep Testing: Is It a Sleeper? What are the drivers:

Financial Costs

Payors Patient?

Opportunity Medical health care providers Manufacturers

Access What are the requirements:

Technology Validated

Coverage Clinical acceptance

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In-Home Sleep Testing: Is It a Sleeper?

Not necessarily As a clinical entity we have responsibilities to

validate what we do Strategies

Start with the payor Kill two birds with one stone

Cost reductions and “research funding” Start out with a manageable population Validate you findings Manage the treatment outcomes Publish your results

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In-Home Sleep Testing: Is It a Sleeper?

Thank You!

Nick Macmillan