LCD/NCD Portal

L28620

 

ORAL APPLIANCES FOR OBSTRUCTIVE SLEEP APNEA

 

Region IV

DME

Jurisdiction C

 

07/01/2012

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o Meet all other applicable Medicare statutory and regulatory requirements.

o 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 detailed written order (DWO) must be received by the supplier before a claim is submitted.

o If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

• A custom fabricated mandibular advancement oral appliance (E0486) used to treat obstructive sleep apnea (OSA) is covered if criteria A - D are met.

• The beneficiary has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the beneficiary for obstructive sleep apnea testing.

• The beneficiary has a Medicare-covered sleep test that meets either of the following criteria (1 - 3):

o The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,

o The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:

 Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,

 Hypertension, ischemic heart disease, or history of stroke; or,

 If the AHI >30 or the RDI >30 and meets either of the following (a or b):

• The beneficiary 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.

• The device is ordered by the treating physician following review of the report of the sleep test.

o (The physician who provides the order for the oral appliance could be different from the one who performed the clinical evaluation in criterion A.)

• The device is provided and billed for by a licensed dentist (DDS or DMD).

• If all of these criteria (A-D) are not met, the custom fabricated oral appliance (E0486) will be denied as not reasonable and necessary.

• Refer to the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the Policy Article for information about coverage for appliances that achieve their effect through positioning of the tongue (A9270).

• A prefabricated oral appliance (E0485) will be denied as not reasonable and necessary.

o There is insufficient evidence to show that these items are effective therapy for OSA.

• Custom fabricated mandibular advancement devices that have not received a written coding verification from the Pricing, Data Analysis and Coding (PDAC) contractor will be denied as not reasonable and necessary.

 

• Definitions

o As used in this policy, physician refers to a licensed MD, DO, nurse practitioner, clinical nurse specialist, or physician's assistant working within their scope of practice. The term physician does not include a dentist (DDS or DMD).

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

o 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.

o 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.

 For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI.

 Sleep time can only be measured in a Type I (facility-based polysomnogram) or Type II sleep study (see descriptions below).

o The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device.

 For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI.

 The RDI is reported in Type III, Type IV, and Other home sleep studies.

o 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).

 Projections of AHI or RDI based upon shorter testing times and/or fewer events are not acceptable for use in determining eligibility for payment.

 

• Sleep Tests

o 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 oral appliances used to treat OSA, the DME MAC coverage, coding and payment rules take precedence.

o 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, Other).

 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, IV, Other).

 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.

o 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)

• electro-oculogram (EOG)

• submental electromyogram (EMG)

• Electrocardiogram (ECG).

 It must also include at least the following additional parameters of sleep:

• Airflow

• respiratory effort

• 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.

o 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:

 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,

 Type III device – Monitors and records a minimum of four (4) channels: respiratory movement/effort, airflow, ECG/heart rate and oxygen saturation; or,

 Type IV device - Monitors and records a minimum of three (3) channels, one of which is airflow; or,

 Other - Devices that monitor and record a minimum of three (3) channels that include actigraphy, oximetry and peripheral arterial tone and for which there is substantive clinical evidence in the published peer-reviewed medical literature that demonstrates that the results accurately and reliably correspond to an AHI or RDI as defined above.

• This determination will be made on a device-by-device basis

o (WatchPAT (Itamar Medical) is currently the only approved device in this category).

o 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. Beneficiary instruction may be accomplished by either:

• Face-to-face demonstration of the portable sleep monitoring device's application and use; or,

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

o All sleep tests must be interpreted by a physician who holds either:

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

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

 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,

 Active staff membership of a sleep center or laboratory accredited by

• the American Academy of Sleep Medicine (AASM), Accreditation Commission for Health Care (ACHC) or

• The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations – JCAHO).

o 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.

 

 

Bill Type Codes:

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

Revenue Codes:

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

CPT/HCPCS Codes

 

• The appearance of a code in this section does not necessarily indicate coverage.

 

 

HCPCS MODIFIERS:

 

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

 

GA - Waiver of liability statement issued, as required by payer policy

 

GZ - Item or service expected to be denied as not reasonable and necessary

 

KX - Requirements specified in the medical policy have been met

 

 

HCPCS CODES:

 

A9270 NON-COVERED ITEM OR SERVICE

E0485 ORAL DEVICE/APPLIANCE USED TO REDUCE UPPER AIRWAY COLLAPSIBILITY, ADJUSTABLE OR NON-ADJUSTABLE, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

E0486 ORAL DEVICE/APPLIANCE USED TO REDUCE UPPER AIRWAY COLLAPSIBILITY, ADJUSTABLE OR NON-ADJUSTABLE, CUSTOM FABRICATED, INCLUDES FITTING AND ADJUSTMENT

E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS

 

ICD-9 Codes that Support Medical Necessity

 

• The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on Indications and Limitation of Coverage and/or Medical Necessity for other coverage criteria and payment information.

 

327.23 OBSTRUCTIVE SLEEP APNEA (ADULT) (PEDIATRIC)

 

 

Documentations 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."

o It is expected that the beneficiary's medical records will reflect the need for the care provided.

o The beneficiary'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.

 

 

• PRESCRIPTION (ORDER) REQUIREMENTS

• GENERAL (PIM 5.2.1)

o All items billed to Medicare require a prescription.

 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 dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

 

• DISPENSING ORDERS (PIM 5.2.2)

o Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery.

 A dispensing order may be verbal or written.

 The supplier must keep a record of the dispensing order on file.

 It must contain:

• Description of the item

• Beneficiary's name

• Prescribing Physician's name

• Date of the order and the start date, if the start date is different from the date of the order

o Physician signature (if a written order) or supplier signature (if verbal order)

o For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

o Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

o The dispensing order must be available upon request.

o For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

 

• DETAILED WRITTEN ORDERS (PIM 5.2.3)

o A detailed written order (DWO) is required before billing.

 Someone other than the ordering physician may produce the DWO.

 However, the ordering physician must review the content and sign and date the document.

 It must contain:

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if start date is different from the date of the order

• Detailed description of the item(s) (see below for specific requirements for selected items)

• Physician signature and signature date

o For items provided on a periodic basis, including drugs, the written order must include:

 Item(s) to be dispensed

 Dosage or concentration, if applicable

 Route of Administration

 Frequency of use

 Duration of infusion, if applicable

 Quantity to be dispensed

 Number of refills

o For the "Date of the order" described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

o Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed.

 Reimbursement shall be based on the specific utilization amount only.

 Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

o The detailed description in the written order may be either a narrative description or a brand name/model number.

o Signature and date stamps are not allowed.

 Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

o The DWO must be available upon request.

o A prescription is not considered as part of the medical record.

 Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

 

 

• MEDICAL RECORD INFORMATION

• GENERAL (PIM 5.7 - 5.9)

o The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contain numerous reasonable and necessary (R&N) requirements.

 The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified.

 Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

o Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs.

 The medical record is not limited to physician's office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive).

 Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

 

• PROOF OF DELIVERY (PIM 4.26, 5.8)

o Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files.

 For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement.

 Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

o Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary

• (i.e., acting as a designee on behalf of the beneficiary).

 The signature and date the beneficiary or designee accepted delivery must be legible.

o For the purpose of the delivery methods noted below, designee is defined as any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary.

o Proof of delivery documentation must be available to the Medicare contractor on request.

 All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested.

 Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

 Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

• Delivery directly to the beneficiary or authorized representative

• Delivery via shipping or delivery service

• Delivery of items to a nursing facility on behalf of the beneficiary

 

• Method 1—Direct Delivery to the Beneficiary by the Supplier

• Suppliers may deliver directly to the beneficiary or the designee.

o In this case, POD to a beneficiary must be a signed and dated delivery slip. The POD record must include:

 Beneficiary's name

 Delivery address

 Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

 Quantity delivered

 Date delivered

 Beneficiary (or designee) signature and date of signature

o The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee.

 In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

 

• Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

• If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary.

o An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information.

o The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary.

o The POD record must include:

 Beneficiary's name

 Delivery address

 Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

 Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

 Quantity delivered

 Date delivered

 Evidence of delivery

o If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

o Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

 

• Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

• When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

• When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

• Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by the beneficiary must be available upon request.

 

 

• POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

 

• 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.

o If the requirements for the KX modifier are not met, the KX modifier must not be used.

• If all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the oral appliance.

o When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

o Claim lines billed without a GA, GZ, or KX modifier will be rejected as missing information.

• Physicians shall document the face-to-face clinical evaluation in a detailed narrative note in their charts in the format that they use for other entries.

o The report would commonly document pertinent information about the following elements, but may include other details.

o Each element would not have to be addressed in every evaluation.

 History

 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

 Focused cardiopulmonary and upper airway system evaluation

 Neck circumference

 Body mass index (BMI)

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

 

• Appendices

o PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8.

 

 

• EPWORTH SLEEPINESS SCALE

o 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.

o Use the following scale to choose the most appropriate number for each situation:

 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



Situation  Chance of Dozing or Sleeping

Sitting and reading  ____

Watching TV  ____

Sitting inactive in a public place  ____

Being a passenger in a motor vehicle for an hour or more  ____

Lying down in the afternoon  ____

Sitting and talking to someone  ____

Sitting quietly after lunch (no alcohol)  ____

Stopped for a few minutes in traffic while driving  ____

Total score (add the scores up)

(This is your Epworth score)  ____

0-9 – Average score, normal population

o Epworth Sleepiness Scale reprinted with permission of the Associated Professional Sleep Societies (Johns MW; A New Method for Measuring Daytime Sleepiness:

o The Epworth Sleepiness Scale. SLEEP 1991;14(6):540-545).

 

Sources of Information and Basis for Decision

 

A50454 - Oral Appliances for Obstructive Sleep Apnea - Policy Article - Effective July 2012

 

Local Coverage Determination (LCD) for Oral Appliances for Obstructive Sleep Apnea (L28620)