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«18 September 2008 Dear Physician, Supplier, Specialty Group: The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical ...»

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Durable Medical Equipment

Medicare Administrative Contractor

18 September 2008

Dear Physician, Supplier, Specialty Group:

The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical Equipment

Medicare Administrative Contractors (DME MACs) the task of developing and updating medical policies

for the purpose of processing and reviewing Medicare claims for Durable Medical Equipment, Prostheses,

Orthoses and Supplies (DMEPOS). The DME MACs are proposing a new policy for Oral Appliances for Obstructive Sleep Apnea.

We are soliciting comments on this draft policy from physicians, manufacturers, suppliers and other professionals involved in the ordering or provision of these items. We recommend that you send this draft policy to selected members of your organization for review and comment. If you disagree with any aspect of the policy, you should be very specific and, if possible, offer an alternative indication, guideline, etc. You should provide a clinical rationale for your position including references from the published clinical literature (e.g. standard textbooks, peer-reviewed journals, etc.). We would also encourage a written response if you agree with this policy.

When comments of this policy have been received, they will be reviewed and revisions to the policy will be considered. The revised policy will be published in the CMS Medicare Coverage Database and on individual DME MAC websites, allowing for adequate notice before the policy’s effective date.

Please submit your comments to each DME MAC medical director by mail at the addresses below no later than November 3, 2008. Comments may also be submitted via e-mail through each DME MAC’s web site. In addition, a public meeting for receiving comments will be conducted by each of the DME MACs. Information regarding submission of email comments and the open meeting may be obtained from the DME MAC web sites.

Thank you for your participation in our policy development process.

Sincerely yours, Robert D. Hoover, Jr., MD, MPH, FACP Paul J. Hughes, M.D.

Medical Director, DME MAC, Jurisdiction C Medical Director, DME MAC, Jurisdiction A NHIC CIGNA Government Services 75 Sgt. William B. Terry Drive 2 Vantage Way (795) Hingham, MA 02043 Nashville, TN 37228 www.medicarenhic.com www.cignagovernmentservices.com Adrian M. Oleck, M.D. Richard W. Whitten, MD, MBA Medical Director, DME MAC, Jurisdiction B Medical Director, DME MAC, Jurisdiction D Nationa

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LCD Title Oral Appliances for Obstructive Sleep Apnea Contractor's Determination Number AMA CPT / ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2005 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors, and other data contained therein) is copyright by the American Dental Association.

© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy None

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Oversight Region CMS Consortium DMERC Region LCD Covers Original Determination Effective Date For services performed on or after xxxxxxxxxxxxxxx Original Determination Ending Date Revision Effective Date Revision Ending Date Indications and Limitations of Coverage and/or Medical Necessity For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

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A The patient has a face-to-face clinical evaluation by the treating physician (MD or DO) prior to the sleep test to assess the patient for obstructive sleep apnea.

B The patient has a Medicare-covered sleep test that meets either of the

following criteria (1 or 2):

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C The patient is not able to tolerate a positive airway pressure (PAP) device or the treating physician determines that the use of a PAP device is contraindicated.

D The device is provided by a licensed dentist (DDS or DMD).

If all of these criteria are not met, the oral appliance will be denied as not medically necessary.

A custom fabricated oral appliance (E0486) is covered only if there is an anatomical abnormality of the mouth, jaw, or throat that cannot be accommodated by a prefabricated appliance (E0485). If this criterion is not met but the general coverage criteria (A-D above) are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0485.

Definitions Apnea is defined as the cessation of airflow for at least 10 seconds.

Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device.

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airway pressure device.

If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2 hour period (i.e., must reach ≥30 events without symptoms or ≥10 events with symptoms).

Sleep Tests

Coverage and Payment rules for sleep tests may be found in the local coverage determinations (LCDs) for the applicable Medicare Part A or Part B contractor.

There may be differences between those LCDs and the DME MAC LCD. For the purposes of coverage of PAP therapy, the DME MAC coverage, coding and payment rules take precedence.

Coverage of an oral appliance for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a Medicare-covered sleep test (Type I, II, III, IV). A Medicare-covered sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or a home sleep test (HST) (Types II, III, or IV). The test must be ordered by the beneficiary’s treating physician and conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

A Type I sleep test is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It is facility-based and must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), submental electromyogram (EMG) and electrocardiogram (ECG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. It may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

An HST is performed unattended in the beneficiary’s home using a portable monitoring device. A portable monitoring device for conducting an HST must

meet one of the following criteria:

A. Type II device – Monitors and records a minimum of seven (7) channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory movement/effort and oxygen saturation; or,

B. Type III device – Monitors and records a minimum of four (4) channels:

respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or, C. Type IV device – Monitors and records a minimum of three (3) channels that allow direct calculation of an AHI or RDI as defined above. Devices that record channels that do not allow direct calculation of an AHI or RDI may be considered as acceptable alternatives if there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an DRAFT 5 of 13 5 AHI or RDI. This determination will be made on a device-by-device basis. Currently there is no device that indirectly measures AHI or RDI that meets this criterion.

All beneficiaries who undergo a HST must, prior to having the test, receive instruction on how to properly apply a portable sleep monitoring device. This instruction must be provided by the entity conducting the HST and may not be performed by a DME supplier. Patient instruction may be accomplished by


1. Face-to-face demonstration of the portable sleep monitoring device’s application and use; or,

2. Video or telephonic instruction, with 24-hour availability of qualified personnel to answer questions or troubleshoot issues with the device.

All HSTs (Type II, III, or IV) must be interpreted by a physician who holds


1. Current certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM); or,

2. Current subspecialty certification in Sleep Medicine by a member board of the American Board of Medical Specialties (ABMS); or,

3. Completed residency or fellowship training in a program approved by an ABMS member board and has completed all the requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible; or,

4. Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

For oral appliances with dates of service on or after January 1, 2010, physicians interpreting facility-based polysomnograms (Type I) must meet one of the requirements listed above (1-4) for credentialing.

No aspect of an HST, including but not limited to delivery and/or pickup of the device, may be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests Coverage Topic DME

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EY - No physician or other licensed health care provider order for this item or service.

KX - Specific required documentation on file.


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ICD-9 Codes that Support Medical Necessity 327.23 – Obstructive Sleep Apnea (Adult) (Pediatric) Diagnoses that Support Medical Necessity All diagnosis that are specified in the preceding section.

ICD-9 Codes that DO NOT Support Medical Necessity All ICD-9 codes that are not specified in the preceding section ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

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All diagnoses that are not specified in the preceding section.

General Information Documentation Requirements Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

The ICD-9 code that justifies the need for these items must be included on the claim.

Suppliers must add a KX modifier to a code only if all of the criteria in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.

Physicians shall document the face-to-face clinical evaluations in a detailed narrative note in their charts in the format that they use for other entries. The report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation.


• Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches;

• Duration of symptoms

• Validated sleep hygiene inventory such as the Epworth Sleepiness Scale (see Appendices) Physical Exam

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Refer to the Supplier Manual for additional information on documentation requirements.



How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently try to work out how they would have affected you.

Use the following scale to choose the most appropriate number for each


0 = would never doze or sleep.

1 = slight chance of dozing or sleeping 2 = moderate chance of dozing or sleeping 3 = high chance of dozing or sleeping

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