MEDICAL POLICY

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SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea

Number 1.01.524

Effective Date April 14, 2015

Revision Date(s) 04/14/15; 07/14/14; 01/13/14; 02/11/13

Replaces N/A

Policy

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First Time Positive Airway Pressure (PAP) Device User

A continuous positive airway pressure (CPAP) device may be considered medically necessary for adult or pediatric patients* diagnosed with obstructive sleep apnea (OSA) when the following criteria are met:

  • A physician with training in sleep disorders evaluated the patient and ordered the CPAP device and
  • Prior to purchase there is documentation of adherence** to a 3-months (12 weeks) trial of rented PAP device use.

A bi-level positive airway pressure (BiPAP/BPAP) or auto-adjusting PAP (APAP) device may be considered medically necessary for patients diagnosed with OSA when the following criteria are met:

  • The trial of CPAP was ineffective in resolving OSA symptoms (see Definition of Terms) and
  • A physician with training in sleep disorders evaluated the patient and ordered the BiPAP device and
  • Prior to purchase there is documentation of adherence** to a 3-months (12 weeks) trial of rented BiPAP device use.

*NOTE: Children’s symptoms of OSA may differ from adults’ symptoms of OSA. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness. Usually an adenotonosillectomy surgery is the first-line treatment for OSA in children. CPAP is an option for those children who are not surgery candidates or who have an inadequate response to surgery.

** Adherence to therapy means:

  • The patient used the PAP device 4 or more hours on 70% of nights in any 30 day period during the first 3-months (12 weeks) of use.
  • A claim submitted with the KX modifier is considered documentation of adherence. (See Documentation section in Policy Guidelines and Coding section)

PAP Accessories and Supplies

Accessories and supplies may be considered medically necessary when used with a PAP device eligible for coverage benefits.

PAP Device Initiation with Titration

  • Unattended home based APAP titration of pressure may be considered medically necessary for adult patients diagnosed with OSA who do not have other health conditions.
  • Attended (facility/laboratory) PAP device titration may be considered medically necessary for patients when:
  • Unattended/home PAP titration fails to control OSA symptoms or
  • Unattended/home PAP titration is contraindicated due to other health conditions (see list below).

Health conditions that are contraindications to unattended titration include but are not limited to the following:

  • Central sleep apnea
  • Congestive heart failure
  • Hypo-ventilation syndrome
  • Moderate to severe pulmonary disease
  • Narcolepsy
  • Neuromuscular disease
  • Under 19 years of age

Facility/laboratory based PAP device titration is considered not medically necessary when adult patients meet criteria for unattended/home based titration.

Current PAP Device User

When a patient owned PAP device is accidently damaged, broken beyond repair, lost, or stolen, then replacement equipment may be eligible for benefits. (See Policy Guidelines)

Other Devices Used for OSA Treatment

  • Intra-Oral Devices

Intra-oral devices for treatment of obstructive sleep apnea are addressed in a separate medical policy. (See Related Policies)

  • Nasal Expiratory Positive Airway Pressure (EPAP) Device

EPAP devices are considered investigational to treat OSA. An example of this is The ProventĀ® Professional Sleep Apnea Therapy Device.

  • Oral Pressure Therapy (OPT) Device

OPT devices are considered investigational to treat OSA. An example of this is The Winx™ Sleep Therapy System.

NOTE: See Policy Guidelines for additional information about coverage eligibility for PAP devices.

Related Policies

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1.01.526

Durable Medical Equipment Repair/Replacement (Excluding Wheelchairs and C/BiPap Machines)

2.01.503

Polysomnography and Home Sleep Study for Diagnosis of Obstructive Sleep Apnea

2.01.532

Intra Oral Devices for Treatment of Obstructive Sleep Apnea

7.01.554

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Policy Guidelines

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PAP Device Coverage Eligibility – Rental/Purchase/Repair/Replacement

Rental

Coverage for Initial PAP Device Rental

For a patient who is new to using a PAP device, prior to purchase, the Company requires documentation of adherence to a 3-months (12 weeks) trial of rented PAP device use. (Definition of Terms for “adherence” and Replacement section for exception to the trial use/rental requirement is in following subheadings.)

Coverage for Continued PAP Device Rental/Failed Initial PAP Device Trial

If a patient fails to meet the adherence criteria during the First 3-month trial rental period, a second 3-month (12 weeks) rental for a CPAP trial, when requested, may be considered if documentation is submitted showing:

  • The patient was re-evaluated by the treating physician or respiratory therapist and
  • Prior to purchase the patient adhered to using the PAP device during the Second 3-months (12 weeks) trial rental period.

If a CPAP device was used for more than 3 months without OSA symptom relief and the physician ordered a BiPAP device, a clinical re-evaluation must be completed before benefits are provided. There must be documentation of adherence to therapy during the 3-month (12 weeks) trial with the BiPAP device. (See Documentation Section)

Purchase

Purchase of a PAP device is eligible for coverage when medical necessity criteria, adherence to therapy and documentation requirements as stated in this policy are met.

Repair of PAP Device

Repair of a patient-owned PAP device is eligible for coverage when:

  • The member continues to meet the adherence requirement
  • Repairs are needed to make the device functional due to reasonable wear and tear or accidental damage due to a specific incident
  • The manufacturer’s warranty has expired

Replacement of PAP Device

  • Replacement during the 5 year reasonable useful lifetime (RUL)

Replacement of a patient-owned PAP device during the 5 year RUL because of loss, theft, or irreparable damage due to a specific incident is eligible for coverage.

Note: prior to purchase the patient does not need a new clinical evaluation, sleep test or 3-month rental period.

Replacement of a patient-owned PAP device during the 5 year RUL that does not meet the conditions above is eligible for coverage when:

  • The patient continues to meet the adherence requirement AND
  • The patient’s PAP device is not operating and unable to be repaired as reported by a supplier who has physically evaluated the device AND
  • The patient’s PAP device to be replaced is no longer covered by a warranty, AND
  • The replacement PAP device is dispensed by a qualified provider of PAP devices

Note: prior to purchase the patient does not need a new clinical evaluation, sleep test or 3-month rental period.

  • Replacement at or after the 5 year reasonable useful lifetime (RUL)

Replacement of a member-owned PAP device that has reached or exceeded the 5 year RUL is eligible for coverage. When the following criteria are met:

  • The patient continues to meet the adherence requirement (see Definition of Terms) AND
  • The patient’s PAP device is not operating and unable to be repaired as reported by a supplier who has physically evaluated the device AND
  • The patient’s PAP device to be replaced is no longer covered by a warranty, AND
  • The replacement PAP device is dispensed by a qualified provider of PAP devices

Note: prior to purchase the patient does not need a new clinical evaluation, sleep test or 3-month rental period.

Note: The RA modifier is submitted for replacement of member-owned PAP equipment that meets the above indications. (See Coding section)

Documentation

Medical records for re-evaluations should include detailed narrative notes about the face to face clinical assessment. This information does not have to be submitted with the claim but must be kept by the supplier and treating practitioner(s) and be available if requested. (See Definition of Terms for “adherence” and Coding Section for modifiers)

Re-evaluation

Documentation in the patient’s medical record of visits after PAP therapy starts should include the following:

  • Statement about PAP use adherence and effectiveness of resolving OSA symptoms
  • Plans for ongoing treatment
  • The specific interventions provided to help the patient use the equipment effectively and resolve any ongoing OSA symptoms
  • The reason(s) for a change from a CPAP to BiPAP device, if applicable.

Documentation of adherence

Documentation of adherence to PAP device therapy in the patient’s medical record should include the following:

  • Copy of a usage report from the PAP device’s memory.
  • A statement that the written report was reviewed by the treating physician, respiratory therapist or supplier.

(See Definition of Terms below for the definition of adherence).

Definition of Terms

For the purpose of this policy, the following definitions apply:

  • Ineffective therapy is defined as documented failure to meet therapeutic goals using a CPAP device during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).
  • Adherence to therapy is defined as use of a PAP device for 4 or more continuous hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months/12 weeks of initial usage.
  • A claim submitted with the KX modifier is considered documentation of adherence. (See Documentation section in Policy Guidelines)
  • Obstructive sleep apnea (OSA) is caused by obstruction of the upper airway. Symptoms include repeated pauses in breathing during sleep and are usually associated with a reduction in blood oxygen saturation.
  • Polysomnogram also known as a “sleep study” is a diagnostic test for obstructive sleep apnea. The patient is connected to a variety of monitoring devices that record at least 4 physiologic variables while sleeping (e.g. heart rate, sleep/wake activity, blood oxygen saturation, respiratory effort monitoring).
  • Titration of a PAP device is required to find the right airflow pressure settings of the equipment to keep the patient’s airway open yet allow the patient to sleep. The airflow pressure of the PAP device is “titrated” (increased/decreased) to discover a single fixed pressure that works for the individual. In the home setting a device is used that can perform this titration task automatically.

Description

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There are various types of positive airway pressure devices (i.e., fixed continuous positive airway pressure [CPAP], bi-level positive airway pressure [BPAP], or auto-adjusting positive airway pressure [APAP]). (1) This policy only addresses the use of PAP devices for medical management of obstructive sleep apnea after a sleep study and clinical evaluation confirm the diagnosis. Sleep studies are addressed in a separate policy (see Related Policies).

CPAP involves the administration of air usually through the nose by an external device at a fixed oxygen pressure to maintain the patency of the upper airway.

BPAP is similar to CPAP but these devices are capable of generating two adjustable pressure levels that may be more comfortable for the patient compared to the fixed oxygen level.

APAP adjusts the level of pressure based on the level of resistance, and thus administers a lower mean level of positive pressure during the night. Both BPAP and APAP are considered by some specialists to be more comfortable for the patient, and thus might improve usage compliance or acceptance.

Regulatory Status

A number of CPAP devices have received 510(k) clearance since 1977. BiPAP devices were first cleared for marketing by FDA in 1996. FDA product codes: BZD, MNT

Scope

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Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

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N/A

Rationale

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Giles and colleagues reported that Cochrane reviews concluded that both CPAP and oral appliances resulted in objective and subjective improvements in those with obstructive sleep apnea. (2) Thirty-six randomized trials involving 1,718 people met the inclusion criteria for comparison of nocturnal CPAP with an inactive control or oral appliances in adults with obstructive sleep apnea (defined as AHI greater than 5 per hour). The authors concluded that CPAP is effective in reducing symptoms of sleepiness and improving quality of life measures in people with moderate and severe obstructive sleep apnea. It is more effective than oral appliances in reducing respiratory disturbances but subjective outcomes are more equivocal. Certain people tend to prefer oral appliances to CPAP where both are effective. Short-term data indicate that CPAP leads to lower blood pressure than control. Long-term data are required for all outcomes in order to determine whether the initial benefits seen in short-term clinical trials persist.

Skomro et al. (2010) published results of a randomized controlled trial with 102 subjects consisting of home-based level 3 testing followed by 1 week of auto-CPAP and fixed-pressure CPAP. (3) The outcome measures were measured by daytime sleepiness (ESS), sleep quality (Pittsburgh Sleep Quality Index {PSQI}), quality of life (Calgary Sleep Apnea Quality}, 36-Item Short-Form Health Survey {SF-36}, BP, and CPAP adherence after 4 weeks. Their conclusions stated that compared with the home-based protocol, diagnosis and treatment of OSA in the sleep laboratory does not lead to superior 4-week outcomes in sleepiness scores, sleep quality, quality of life, BP, and CPAP adherence.

In 2011, the Agency for Healthcare Research and Quality (AHRQ) conducted a comparative effectiveness review (CER) on the diagnosis and treatment of OSA in adults. (4) The review found that based on the strength of the evidence that CPAP is rated as moderate for being an effective treatment to alleviate sleep apnea signs and symptoms. The strength of the evidence that mandibular advancement devices improve sleep apnea signs and symptoms was rated moderate, and there was moderate evidence that CPAP is superior to mandibular advancement devices in improving sleep study measures.

Practice Guidelines and Position Statements

American Academy Sleep Medicine (AASM)

In 2008, AASM published Practice parameters (5, 6) on the use of APAP as detailed below:

  1. APAP devices are not recommended to diagnose OSA;
  2. patients with congestive heart failure, patients with significant lung disease such as chronic obstructive pulmonary disease; patients expected to have nocturnal arterial oxyhemoglobin desaturation due to conditions other than OSA (e.g., obesity hypoventilation syndrome); patients who do not snore (either naturally or as a result of palate surgery); and patients who have central sleep apnea syndromes are not currently candidates for APAP titration or treatment;
  3. APAP devices are not currently recommended for split-night titration;
  4. certain APAP devices may be used during attended titration with polysomnography to identify a single pressure for use with standard CPAP for treatment of moderate to severe OSA;
  5. certain APAP devices may be initiated and used in the self-adjusting mode for unattended treatment of patients with moderate to severe OSA without significant comorbidities (CHF, COPD, central sleep apnea syndromes, or hypoventilation syndromes);
  6. certain APAP devices may be used in an unattended way to determine a fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities (CHF, COPD, central sleep apnea syndromes, or hypoventilation syndromes);
  7. patients being treated with fixed CPAP on the basis of APAP titration or being treated with APAP must have close clinical follow-up to determine treatment effectiveness and safety; and
  8. a reevaluation and, if necessary, a standard attended CPAP titration should be performed if symptoms do not resolve or the APAP treatment otherwise appears to lack efficacy.

American College of Physicians (ACP)

The ACP 2013 Guidelines on the management of OSA in adults recommend that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight (strong recommendation, low quality evidence). (7) ACP recommends CPAP as initial therapy for patients diagnosed with OSA (strong recommendation; moderate-quality evidence), and mandibular advancement devices as an alternative therapy to CPAP for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with CPAP (weak recommendation, low-quality evidence). (See Related Policies)

Medicare National Coverage

The use of CPAP devices are covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adults with OSA if either of the following criteria using the AHI or RDI are met:

  • AHI or RDI of 15 events per hour or more, or
  • AHI or RDI between 5 and 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

Additional details of Medicare coverage and updates on PAP devices are available online. (8)

References

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  1. Noridian Administrative Services. Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L171). DME Jurisdiction D. Last accessed March, 2015.
  2. Giles TL, Lasserson TJ, Smith BH et al. Continuous positive airways pressure for obstructive sleep apnea in adults. Cochrane Database Syst Rev. 2006 Jul 19;3:CD001106.
  3. Skomro RP, Gjevre J, Reid J et al. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010 Aug, 138(2):257.
  4. Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32 (Prepared by Tufts Evidence-based Practice Center under Contract No. 290-2007-100551) AHRQ Publication No. 11-EHC052-EF. Rockville MD: Agency for Healthcare Research and Quality Jul 2011.
  5. Morgenthaler TI; Aurora RN; Brown T; et al. Standards of Practice Committee of the AASM. Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: An update for 2007. SLEEP 2008;31(1):141-147. Available at: http://www.aasmnet.org/Resources/PracticeParameters/PP_Autotitrating_Update.pdf Last accessed March, 2015.
  6. Kushida CA, Littner MR, Hirchkowitz M; et al. Practice parameters for the use of continuous and bi-level positive airway pressure devices to treat adult patients with sleep-related breathing disorders. SLEEP 2006; (29) 3: 375-380. Available at: http://www.aasmnet.org/Resources/PracticeParameters/PP_PositiveAirwayPressure.pdf. Last accessed March, 2015.
  7. Qaseem A, Holty JE, Owens DK, et al. Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Sept 2013; 159(7):471-83. Available at: http://annals.org/article.aspx?articleid=1742606. Last accessed March, 2015.
  8. Centers for Medicare and Medicaid Services (CMS). National coverage determination for continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA); 240.4. Available at: http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf. Accessed March, 2015.
  9. BlueCross BlueShield Association (BCBSA). Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome. Medical Policy Reference Manual, Policy No. 2.01.18, 2014

Coding

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Codes

Number

Description

CPT

94799

Unlisted pulmonary service or procedure

ICD-9-CM Diagnosis

327.23

Obstructive sleep apnea (Adult) (Pediatric)

ICD-10-CM
(effective 10/01/15)

G47.33

Obstructive sleep apnea (Adult) (Pediatric)

HCPCS

E0470

Respiratory assist device, Bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)

 

E0471

Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)

 

E0601

Continuous airway pressure (CPAP) device

   

ACCESSORIES

 

A4604

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

 

A7027

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

 

A7028

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

 

A7029

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

 

A7030

Full face mask used with positive airway pressure device, each

 

A7031

Face mask interface, replacement for full face mask, each

 

A7032

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

 

A7033

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

 

A7034

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

 

A7035

Headgear used with positive airway pressure device

 

A7036

Chinstrap used with positive airway pressure device

 

A7037

Tubing used with positive airway pressure device

 

A7038

Filter, disposable, used with positive airway pressure device

 

A7039

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

 

A7044

Oral interface used with positive airway pressure device, each

 

A7045

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

 

A7046

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

 

A9279

Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified

 

E0561

Humidifier, non-heated, used with positive airway pressure device

 

E0562

Humidifier, heated, used with positive airway pressure device

   

MODIFIERS

 

KX

Requirements specified in the medical policy have been met

 

NU

New equipment

 

RA

Replacement of patient-owned DMEPOS due to the expiration of the equipment’s RUL or to loss, irreparable damage, or when the item has been stolen

 

RR

DME rental

Appendix

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N/A

History

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Date

Reason

10/9/2012

New DME policy. Information on CPAP extracted from 2.01.503 to create this policy. The policy has a 90-day hold for provider notification and is effective 2/11/13.

01/24/2013

Removed code E0471. Revised description of continued coverage with modifiers.

08/15/13

Update Related Policies. Change policy title to 2.01.503.

09/11/13

Update Related Policies. Add 1.01.526.

10/16/13

Update Related Policies. Change policy title to 2.01.503.

01/21/14

Revised. Added modifier RA and explanation for use. Clarified replacement language. Clarified continued coverage language.

07/14/14

Interim update. Added titration information. Added Nasal Expiratory Positive Airway Pressure Device and Oral Pressure (Winx) Device information. Policy will be effective October 23, 2014 to correspond with updates to 2.01.532 which are effective on that date.

10/23/14

Reissue policy as updates are now effective; previous version removed from websites.

12/17/14

Coding update. HCPCS code E0471 added to the policy. No other changes.

04/14/15

Annual Review. Policy reviewed with literature search through February 2015. Policy extensively rewritten and reformatted for usability. Policy statements simplified with removal of detailed criteria about the apnea hypoxia index (AHI) and respiratory disturbance index (RDI). Policy Guidelines reformatted and rewritten for ease of use; Purchase and Repair subsections added. Coding table removed from Policy Guidelines. Medicare NCD information added. Reference 6, 7, 8 added; others renumbered. Policy statements simplified as noted.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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