MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
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 January 21, 2014

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

Replaces N/A

Policy

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Initial Coverage

The Company requires a 3 month rental prior to the initial purchase of CPAP equipment.

Note: The only exception is replacement equipment submitted with the RA modifier.

A positive airway pressure device [CPAP, APAP (HCPC E0601) or BPAP (HCPC E0470)] is considered medically necessary for the treatment of obstructive sleep apnea (OSA) if criteria A through C are met:

  1. The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea.
  2. The patient has a sleep test (as defined in a separate medical policy) that meets either of the following criteria (1 or 2):
  1. 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 during the entire sleep test; or,
  2. 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 during the entire sleep test and documentation of:
  1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
  2. Hypertension, ischemic heart disease, or history of stroke.
  1. The patient and/or their caregiver have received instruction from the supplier of the device in the proper use and care of the equipment.

Note: The presentation of OSA in children may differ from that of adults. Children frequently exhibit behavioral problems or hyperactivity rather than daytime sleepiness, and an apnea/hypopnea index (AHI) 1.5 is considered abnormal. In addition, the first-line treatment in children is usually adenotonosillectomy. CPAP is an option for those children who are not candidates for surgery or who have an inadequate response to surgery.

A positive airway pressure device (CPAP, BPAP, APAP) is considered not medically necessary if criteria A through C have not been met.

A bi-level respiratory assist device (BPAP) (HCPC E0470) is considered medically necessary for patients with OSA who meet criteria A through C above and criteria D (below).

  1. A CPAP device has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

A BPAP device is considered not medically necessary if criteria A through D have not been met.

Continued Coverage Beyond the First 3 Months of Therapy

Continued coverage of a PAP device and related accessories is considered medically necessary when no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician conducts a clinical re-evaluation and either the physician or the PAP supplier documents that the patient has improved symptoms using PAP therapy, and is adherent with PAP usage for at least 4 hours/night for more than 70% of nights during any 30 day period in the first 3 months of rental..

Accessories used with a PAP device are considered medically necessary when coverage criteria are met. (See Policy Guidelines.)

Related Policies

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1.01.526

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

2.01.503

Diagnosis of Obstructive Sleep Apnea Syndrome

7.01.101

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Policy Guidelines

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

Ineffective” 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).

If a CPAP device is tried and found ineffective during the initial facility-based titration or home trial, substitution of a BPAP device does not require a new initial face-to-face clinical evaluation or a new sleep test.

Adherence” to therapy is defined as use of PAP > 4 continuous hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.

Patients who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have a face to face clinical re-evaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and proof of effectiveness and adherence (compliance) demonstrated when they re-try.

If a CPAP device is tried and found ineffective during the initial facility-based titration or home trial, substitution of a BPAP does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of a CPAP and objective documentation of adherence on the BPAP would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the CPAP.

If a CPAP device was used for more than 3 months and the patient was then switched to a BPAP, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the BPAP. There would also need to be documentation of adherence to therapy during the 3 month trial with the BPAP.

Coding

HCPCS

Positive Airway Pressure Device

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)

E0601

Continuous positive airway pressure (CPAP) device

Accessories

Maximum Reasonable and Necessary

A4604

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

1 per 3 months

A7027

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

1 per 3 months

A7028

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

2 per 1 month

A7029

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

2 per 1 month

A7030

Full face mask used with positive airway pressure device, each –

1 per 3 months

A7031

Face mask interface, replacement for full face mask, each –

1 per 1 month

A7032

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

2 per 1 month

A7033

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

2 per 1 month

A7034

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

1 per 3 months

A7035

Headgear used with positive airway pressure device

1 per 6 months

A7036

Chinstrap used with positive airway pressure device

1 per 6 months

A7037

Tubing used with positive airway pressure device

1 per 3 months

A7038

Filter, disposable, used with positive airway pressure device

2 per 1 month

A7039

Filter, nondisposable, used with positive airway pressure device

1 per 6 months

A7046

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

1 per 6 months

Patient Compliant Monitoring Devices

A9279

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

Integral to PAP; not eligible for separate reimbursement.

Humidifier

E0561

Humidifier, nonheated, used with positive airway pressure device

Covered when used with allowed E0470 or E0601*

E0562

Humidifier, heated, used with positive airway pressure device

Covered when used with allowed E0470 or E0601*

Modifiers

KX

On initial claims (first through third months) and continued coverage (beyond first 3 months), suppliers must add a KX modifier to codes for PAP equipment. **

Covered when used with allowed E0470 or E0601*

RA

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

Note: RA only needs to be appended to first month claim, and claims should include a narrative explaining the reason for the replacement.

Covered when used with allowed E0470 or E0601*

*When ordered by treating physician and coverage criteria are met.

**If the supplier does not obtain information from the physician that the member has demonstrated improvement in their OSA symptoms and is adhering to PAP therapy in time for submission of the fourth or succeeding months’ claims, the supplier may still submit the claims, but a KX modifier must not be added.

Replacement

If a PAP device is replaced during the 5 year reasonable useful lifetime (RUL) because of loss, theft, or irreparable damage due to a specific incident, there is no requirement for a new clinical evaluation, sleep test, or trial period.

Replacement PAP devices do not need to be rented for three months prior to purchase.

Documentation

Medical records should include detailed narrative notes on the face to face clinical evaluations and re-evaluations. For the initial evaluation, 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.

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

Physical Exam

  • Focused cardiopulmonary and upper airway system evaluation
  • Neck circumference
  • Body mass index (BMI)

For re-evaluation visits after starting PAP therapy, chart notes should document pertinent usage and effectiveness information about how well treatment is working for the patient, along with ongoing plans for treatment.

Documentation of adherence to PAP therapy is shown by a usage report obtained from the PAP machine’s memory. Documentation is provided in a written report format to be reviewed by the treating physician or supplier and included in the member’s medical record (kept by supplier and treating practitioners). This information does not have to be submitted with the claim but must be kept on file and be available upon request.

Description

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CPAP involves the administration of air usually through the nose by an external device at a fixed 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, thought to be more comfortable for the patient. 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. It has been hypothesized that both BPAP and APAP are more comfortable for the patient, and thus might improve patient compliance or acceptance.

There are various types of continuous positive airway pressure (CPAP) (i.e., fixed CPAP, bilevel positive airway pressure [BPAP], or auto-adjusting CPAP [APAP]). This policy only addresses the use of PAP devices for medical management of obstructive sleep apnea.

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.

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. 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. 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.

American Academy Sleep Medicine

Practice parameter on the use of APAP (2008). (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.

Practice parameter for the use of portable monitoring devices (2003). Portable monitoring may be used as an alternative to polysomnography (PSG) for the diagnosis of OSA in patients with a high pretest probability of moderate to severe OSA.

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 September 13, 2012.
  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. Morgenthaler TI; Aurora RN; Brown T; et al.; Standards of Practice Committee of the AASM. Practice parameters for the use of autotitrating 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. http://www.aasmnet.org/Resources/PracticeParameters/PP_Autotitrating_Update.pdf Last accessed September 25, 2012.
  5. Chesson AL Jr., Berry RB, Pack A. American Academy of Sleep Medicine; American Thoracic Society; American College of Chest Physicians. Practice parameters for the use of portable monitoring devices in the investigation of suspected obstructive sleep apnea in adults. Sleep 2003;26(7):907-13.

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 10/01/14)

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)

 

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.


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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