HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
E-20-038
Topic:
Devices Used for the Treatment of Obstructive Sleep Apnea in Adults
Section:
Durable Medical Equipment
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
April 2023
 
 

Positive airway pressure (PAP) devices are indicated for use in the treatment of obstructive sleep apnea (OSA). PAP devices may improve quality of life in individuals with OSA in adults. Close follow-up for PAP device usage and problems in individuals with OSA by appropriately trained health care providers is indicated to establish effective utilization patterns and remediate problems if needed.

Policy Position

Auto-titrating Positive Airway Pressure (APAP) or Continuous Positive Airway Pressure (CPAP)

An APAP device or a CPAP device may be considered medically necessary for the treatment of obstructive sleep apnea (OSA) in adults and covered as durable medical equipment when the following criteria are met:

APAP

  • APAP during a two (2) week trial to initiate and titrate CPAP in adult individuals with a confirmed diagnosis of OSA.

CPAP

  • Individuals have confirmed diagnosis of OSA (confirmed via a positive facility-based polysomnogram (PSG) or with a positive home/portable sleep test); and
  • Apnea/hypopnea index (AHI) as follows:
    • Greater than or equal to 15 events per hour of sleep in an asymptomatic individual; or
    • Greater than five (5) events per hour of sleep in a symptomatic individual (e.g., sleepiness, fatigue, and inattention); or
    • Signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses).

APAP or CPAP devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

E0601

 

 

 

 

 

 




Bi-level Positive Airway Pressure (BiPAP) without back-up rate

BiPAP without back-up rate may be considered medically necessary for the treatment of OSA in adults and may be considered as durable medical equipment when the following criteria are met:

  • Individual has confirmed diagnosis of OSA (confirmed via a positive facility-based PSG or with a positive home/portable sleep test); and
  • AHI greater than or equal to 15 events per hour of sleep in an asymptomatic individual, or
    • Five (5) events per hour of sleep in a symptomatic individual (e.g., sleepiness, fatigue, and inattention) ;or
    • Signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses) and ONE (1) of the following:  
      • Individual has failed a prior trial of CPAP. If the individual is uncomfortable or intolerant of high pressures on CPAP; the individual may be tried on BiPAP. If there are continued obstructive respiratory events at 15 cm H2O of CPAP during the titration study, the individual may be switched to BiPAP; or
      • For whom BiPAP is found to be more effective in the sleep lab.

BIPAP without back-up rate devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

E0470

 

 

 

 

 

 




BiPAP with back-up rate

A BiPAP device with back-up rate is considered not medically necessary with the primary diagnosis of OSA in adults.

E0471

 

 

 

 

 

 




Intra-Oral Appliances

Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) may be considered medically necessary in adult individuals with OSA when ALL of the following criteria are met:

  • AHI greater than or equal to 15 events per hour of sleep in an asymptomatic individual or greater than five (5) events per hour of sleep in a symptomatic individual (e.g., sleepiness, fatigue, and inattention) or signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses); and
  • A trial with CPAP has failed or is contraindicated; and
  • The device is prescribed by a treating physician; and
  • The device is custom-fitted by qualified dental personnel; and
  • There is absence of temporomandibular dysfunction or periodontal disease.

Intra-oral devices not meeting the criteria as indicated in this policy are considered not medically necessary. 

There are many different types of appliances that basically fit into one of two categories, tongue retaining appliances, and mandibular repositioning appliances. Payment may be made for one (1) appliance. Additional appliances are considered not medically necessary. However, replacement of an oral appliance may be considered medically necessary when the item has reached the end of its five (5) year reasonable use lifetime, or when wear and tear renders the item non-functioning and not repairable, and the item is no longer under warranty. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation.

Over-the-counter (OTC) or prefabricated intra-oral appliances to treat OSA are not considered to be appropriate therapy for OSA in any clinical situation and, therefore, are non-covered. 

Note: CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for individuals with severe OSA, as oral appliances have been shown to be less efficacious in individuals with severe OSA than they are in individuals with mild-moderate OSA. Therefore, it is particularly important that individuals with severe OSA should have an initial trial of CPAP and that all reasonable attempts are made to continue treatment with CPAP, prior to the decision to switch to an oral appliance.

E0485

E0486

 

 

 

 

 




Nasal Expiratory Positive Airway Pressure (EPAP)

Nasal EPAP devices (e.g., Provent™, Theravent™) are considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. 

E1399

 

 

 

 

 

 




Oral Pressure Therapy (OPT) 

OPT devices (e.g., Winx® Sleep Therapy System) are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

A7002

A7047

E0600

 

 

 

 




Daytime Electrical Stimulation Devices

Daytime electrical stimulation (eXciteOSA) of the tongue is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-review literature. 

E0490

E0491

K1028

K1029

 

 

 




Sleep Positioning Trainer

 

Sleep positioning trainer with vibration is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-review literature. 

K1001

 

 

 

 

 

 




Payment for the rental of a PAP device

Payment will be made for the rental of a PAP device for the first three (3) months (rental period) from the original start date of therapy, when the above clinical criteria are met. Device expenses incurred during the first three (3) months of rental will be applied to the purchase price. Payment will be made for the purchase of the device when EITHER of the following criteria is met:

  • Documented compliance with objective findings (i.e., compliance chip, tele monitoring, computer software) of device usage for three (3) consecutive months; or
  • The individual is experiencing success in treatment.

Throughout the PAP device rental period, the durable medical equipment (DME) supplier must check that the individual is compliant with use of the device. If the device isn’t being used as prescribed, the DME supplier should contact the individual's physician and discuss removal of the device. If the physician agrees that removal of the machine is warranted, the supplier must remove the machine and discontinue billing for the rental. However, if the individual is found to be using the PAP device as directed and is achieving the desired results, the DME supplier must contact the individual's physician near the end of the rental period and ask the doctor to prescribe the purchase of the device. Non-compliance, with the prescribed PAP therapy will render the PAP device as a non-covered service.

Compliance monitoring equipment for CPAPs, APAPs, or BiPAPs (e.g., smart card, compliance chip, tele monitoring, and computer software) is considered an integral component of the function of the device and is not eligible for separate reimbursement.

Continued use beyond the first three (3) months of therapy
The medical records must also document objective findings of compliance information, (i.e. compliance chip, tele monitoring, computer software), confirming that the individual has been adhering to PAP therapy and is benefiting from its use. Adherence to therapy is defined as use of PAP greater than or equal to four (4) hours per night on 70% of nights during a consecutive 30-day period anytime during the first three (3) months of initial usage.

Replacement of PAP Devices
Replacements of PAP devices for individuals with an existing diagnosis of OSA do not need a compliance chip if documentation of previous compliance, (i.e., compliance chip, tele monitoring, computer software), has been confirmed in the medical record.

E0470

E0471

E0601

 

 

 

 




Cleaning Devices

PAP devices have directions from the manufacturing company included for cleaning. CPAP sanitizer cleaning systems are considered convenience items and therefore non-covered. 

E1399

 

 

 

 

 

 




Accessories

Accessories used with a positive airway pressure (PAP) device may be considered medically necessary when the criteria for the device are met. If the criteria are not met, the accessories are considered not medically necessary.

Liners
Liners are not interfaces for use with a PAP mask. Liners are products placed between the individual's skin and the PAP mask interface and are made of cloth, silicone or other materials. These are not considered “interfaces” as defined in this policy.

Liners must not be billed as replacement interface for a PAP mask or as a replacement cushion for use on nasal mask interface.

A liner used in conjunction with a PAP mask is considered a comfort and convenience item and is considered a non-covered item or service. 

There is no additional payment for liners used with a PAP mask.

A replacement cushion/pillow is not billable when supplying an ongoing replacement of the frame with cushion/pillow. Billing for each individual component is considered unbundling of these supplies. The allowance of a replacement mask interface every month is considered an exception and documentation should support the medical necessity.

Note: See table below  for the usual maximum amount of accessories considered to be medically necessary. A replacement device is not covered if due to misuse or abuse and is considered a non-covered service. 

Accessories

A4604

1 per 3 months

Tubing with integrated heating element for use with positive airway pressure device

A7027

1 per 3 months

Combination oral/nasal mask, used with continuous positive airway pressure device, each

A7028

2 per 1 month

Oral cushion for combination oral/nasal mask, replacement only, each

A7029

2 per 1 month

Nasal pillows for combination oral/nasal mask, replacement only, pair

A7030

1 per 3 months

Full face mask used with positive airway pressure device, each

A7031

1 per 1 month

Face mask interface, replacement for full face mask, each

A7032

2 per 1 month

Cushion for use on nasal mask interface, replacement only, each

A7033

2 per 1 month

Pillow for use on nasal cannula type interface, replacement only, pair

A7034

1 per 3 months

Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap

A7035

1 per 6 months

Headgear used with positive airway pressure device

A7036

1 per 6 months

Chinstrap used with positive airway pressure device

A7037

1 per 3 months

Tubing used with positive airway pressure device

A7038

2 per 1 month

Filter, disposable, used with positive airway pressure device

A7039

1 per 6 months

Filter, non-disposable, used with positive airway pressure device

A7044

1 per 3 months

Oral interface used with positive airway pressure device, each

A7045

1 per 3 months

Exhalation port with or without swivel used with accessories for positive airway pressure devices, replacement only

A7046

1 per 6 months

Water chamber for humidifier, used with positive airway pressure device, replacement, each


** Allowing for a three (3) month supply* Allows for a 10 day delivery before run-out

Quantities of supplies greater than those identified as the usual maximum amounts are considered not medically necessary.

Regardless of utilization, a supplier must not dispense more than a three (3) month quantity at a time.

Either a heated humidifier or a non-heated humidifier may be considered medically necessary for use with a covered PAP device when prescribed by the treating physician to meet the needs of the individual.  

A4604

A7027

A7028

A7029

A7030

A7031

A7032

A7033

A7034

A7035

A7036

A7037

A7038

A7039

A7044

A7045

A7046

A7049

A9270

E0561

E0562

E1399

S8186

 

 

 

 

 




Related Policies

Refer to Medical Policy E-34, Respiratory Assist Devices for additional information.

Refer to Medical Policy Z-8, Diagnosis and Treatment of Obstructive Sleep Apnea for Adults for additional information. 

Refer to Medical Policy Z-64, Diagnosis and Treatment of Obstructive Sleep Apnea in Children for additional information.

Refer to Reimbursement Policy RP-070, Continuous Rental of Life Sustaining DME, for additional information.


Professional Statements and Societal Positions Guidelines

According to the American Academy of Sleep Medicine (AASM) obstructive sleep apnea (OSA) in adults is defined as either:

  • More than fifteen (15) apneas, hypopneas, or respiratory effort related arousals (RERAs) per hour of sleep (i.e., an apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) greater than fifteen (15) events/hr) in an asymptomatic individual; or
  • More than five (5) apneas, hypopneas, or RERAs per hour of sleep (i.e., an AHI or RDI greater than five (5) events per hour) in an individual with symptoms (e.g., sleepiness, fatigue, and inattention), or signs of disturbed sleep (e.g., snoring, restless sleep, and respiratory pauses). More than 75% of the apneas or hypopneas must have an obstructive pattern.

The AASM classifies mild, moderate, and severe OSA as:

  • Mild OSA: AHI of 5-15
    • Involuntary sleepiness during activities that require little attention, such as watching TV or reading.
  • Moderate OSA: AHI of 15-30
    • Involuntary sleepiness during activities that require some attention, such as meetings or presentations.
  • Severe OSA: AHI of greater than 30
    • Involuntary sleepiness during activities that require more active attention, such as talking or driving.


Covered Diagnosis Codes for procedure code E0601

G47.33

 

 

 

 

 

 

 

 

Non-Covered Diagnosis Codes for procedure code E0471

G47.33

 

 

 

 

 

 

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

A device used for the treatment of obstructive sleep apnea in adults is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.