Highmark Medicare Services

12102, 12202, 12302, 12501, 12301, 12201

MAC Part A & B

L27530

Sleep Disorders Testing

L27530

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7).  This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

CMS Internet On-Line Manual Pub. 100-3, Chapter 1, Section 240.4 and Section 30.4.

CMS Internet On-Line Manual Pub. 100-2, Chapter 15, Section 70.

CMS Internet On-Line Manual Pub 100-2, Chapter 6, Section 50.

Coverage Decision Memorandum for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)

Pennsylvania, Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after 08/01/2008

08/31/2008

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

NOTE: This LCD does not address (1) diagnostic testing for non-sleep disorders performed in a sleep disorders clinic (e.g., nocturnal penile tumescence testing); and (2) diagnostic testing for sleep disorders in pediatric patients.

Normal nocturnal sleep in adults is a cyclic phenomenon consisting of two (2) distinct states: rapid eye movement (REM), also called dream sleep since most dreaming occurs in this state, and non-rapid eye movement (NREM).

Sleep studies and polysomnography refer to the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep for 6 or more hours with physician review, interpretation and report. Less than 6 hours of recording may be utilized if a definitive diagnosis can be made prior to that time. The studies are performed to diagnose sleep disorders and/or evaluate a patient’s response to therapies such as nasal continuous positive airway pressure (CPAP).

Per the CMS decision memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2), the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) is calculated on the average number of events per hour. If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing must be at minumum the number of events that would have been required in a 2 hour period.

Poloysomnography is defined to include, but is not limited to, the following:

Multiple sleep latency testing (MSLT) involves several 20 minute nap opportunities offered at 2 hour intervals. The MSLT is designed to objectively assess sleep tendency by measuring the number of minutes it takes the patient to fall asleep as well as premature occurences of REM sleep. To insure validity, interpretation of the MSLT should only be made following a PSG performed on the preceeding night. The mean sleep latency on the MSLT indicating excessive daytime sleepiness should be 8 minutes or less.

Covered Indications
All reasonable and necessary diagnostic tests provided in a sleep center are covered when the following criteria are met:

• The center is under the direction and control of a physician/Medical Director. Diagnostic testing routinely performed in sleep disorder laboratories may be covered even in the absence of direct supervision by a physician when data is interpreted by a physician.
• Patients are referred to the sleep disorder center by a physician, and the center maintains a record of the physician's orders and referral.
• The sleep test must have been ordered by the beneficiary's treating physician and furnished under appropriate physician supervision.
• The need for diagnostic testing is confirmed by medical evidence, e.g., physician histories and examinations (for example including the sleep history; and exams of the respiratory, cardiovascular, and neurological systems) and any applicable laboratory/diagnostic tests, all documented in the patient’s clinical records.

Diagnostic testing is covered only if the patient has the symptoms or complaints of one of the conditions listed below. Patients who undergo the diagnostic testing are not considered inpatients, although they may come to the facility in the evening for testing and then leave after their tests are over. The overnight stay is considered an integral part of these tests.

Sleep disorder testing performed during the acute phase of an illness or injury is not appropriate.

Narcolepsy. -- Narcolepsy is a neurologic disorder of unknown etiology characterized predominantly by abnormalities of REM, some abnormalities of NREM sleep and the presence of excessive daytime sleepiness often with involuntary daytime sleep episodes. Other associated symptoms of narcolepsy include cataplexy and other REM sleep phenomena, such as sleep paralysis and hypnogogic hallucinations.

Related diagnostic testing is covered if the patient has inappropriate sleep episodes or attacks (e.g., while driving, in the middle of a meal, in the middle of a conversation), amnesiac episodes or continuous disabling drowsiness. The sleep disorder clinic must maintain documentation that this condition is severe enough to interfere with the patient's well-being and health.

The diagnosis of narcolepsy is usually confirmed by overnight polysomnography followed by a multiple sleep latency test (MSLT) the next day. The following measurements are normally required to diagnose narcolepsy:

1. PSG assessment of the quality and quantity of night-time sleep;
2. mean sleep latency of 8 minutes or less for 4 or more naps in the MSLT; and
3. The presence of two or more sleep-onset REM periods during the MSLT.

Sleep Apnea. -- Sleep Apnea is a respiratory dysfunction resulting in cessation or near cessation of respiration during sleep. These cessations of breathing may be due to either an occlusion of the airway (obstructive sleep apnea), absence of respiratory effort (central sleep apnea), or a combination of these factors (mixed sleep apnea). Central sleep apnea is a relatively rare entity. Obstructive sleep apnea (OSA) is caused by one of the following: (1) reduced upper airway caliber due to obesity, adenotonsillar hypertrophy, mandibular deficiency, macroglossia, or upper airway tumor; (2) excessive pressure across the collapsible segment of the upper airway; or (3) activity of the muscles of the upper airway insufficient to maintain patency.

The diagnosis of sleep apnea may be made using the following modalities:

1. Polysomnography (PSG) performed in a sleep laboratory; or
2. unattended home sleep monitoring device of type II; or
3. unattended home sleep monitoring device of type III; or
4. unattended home sleep monitoring device of type IV, measuring at least 3 channels (CAG-00093R2)

A positive test for obstructive sleep apnea (OSA) is established if either of the following criteria using the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) are met:

• AHI or RDI greater than or equal to 15 events per hour, or
• AHI or RDI greater than or equal to 5 and less than or equal to 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.

The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour.

If the AHI or RDI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a 2 hour period (CAG-00093R2).

CPAP is a non-invasive technique for providing single levels of air pressure from a flow generator, via a nose mask. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in OSA.

The use of CPAP devices is covered under Medicare when ordered and prescribed by the licensed treating physician to be used in adult patients with OSA if either of the criteria noted above are met.

Documentation supporting a diagnosis of OSA must be available upon request by Medicare.

Repeat PSG for diagnosing sleep apenea requires documentation justifying the medical necessity for the repeat test.

The supplier of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device. A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate the CPAP device.

Follow up polysomnography is indicated for any of the following:

• to evaluate the response to treatment (CPAP, oral appliances, surgical intervention);
• after substantial weight loss has occurred in patients on CPAP for treatment of sleep-related breathing disorders to ascertain whether CPAP is still needed at the previously titrated pressure;
• after substantial weight gain has occurred in patients previously treated with CPAP successfully, who are again symptomatic despite the continued use of CPAP, to ascertain whether pressure adjustments are needed;
• when clinical response is insufficient or when symptoms return despite a documented good initial response to treatment with CPAP; or
• when there has been a significant change in cardiorespiratory status, such as the development or worsening of CHF or LV dysfunction.

Coverage with Evidence Development (CED): Medicare provides the following limited coverage for CPAP in adult beneficiaries who do not qualify for CPAP coverage based on the criteria listed above. A clinical study seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must address one or more of the following questions:

1. In Medicare aged subjects with clinically identified risk factors for OSA, how does the diagnostic accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying subjects with OSA who will respond to CPAP?

2. In Medicare aged subjects with clinically identified risk factors for OSA who have not undergone confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm?

   The study must meet the following additional standards:

3. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.

4. The research study is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

5. The research study does not unjustifiably duplicate existing studies.

6. The research study design is appropriate to answer the research question being asked in the study.

7. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.

8. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is FDA-regulated, it also must be in compliance with 21 CFR Parts 50 and 56.

9. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.

10. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.

11. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life-threatening as defined in 21 CFR § 312.81(a) and the patient has no other viable treatment options.

12. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.

13. The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. However, a full report of the outcomes must be made public no later than three (3) years after the end of data collection.

14. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.

15. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Parasomnias include the following conditions: confusion arousals, sleepwalking (Somnambulism), sleep terrors, REM sleep behavior disorder, sleep-related epilepsy, sleep bruxism, sleep enuresis, and miscellaneous (nocturnal headbanging, sleep talking, restless leg syndrome, periodic limb movement disorder, and nocturnal leg cramps).

Some of the more common, uncomplicated, noninjurious parasomnias, such as typical disorders of arousal, nightmares, enuresis, somniloquy, and bruxism can usually be diagnosed by clinical evaluation alone. A clinical history, neurologic exam and routine EEG obtained while the patient is awake and asleep are often sufficient to establish the diagnosis and permit the appropriate treatment of sleep related epilepsy.

Polysomnography, including video recording and additional EEG channels in an extended bilateral montage, is routinely indicated to assist with the diagnosis of paroxysmal arousals or other sleep disruptions that are thought to be seizure related when the initial clinical evaluation and results of a standard EEG are inconclusive. Polysomnography is not routinely indicated for patients with epilepsy who have no specific symptoms consistent with a sleep disorder.

Polysomnography is indicated to provide a diagnostic classification or prognosis when both of the following exist: the clinical evaluation and results of standard EEG have not demonstrated a seizure disorder; and there is a history of repeated violent or injurious episodes during sleep. Normally when polysomnography is performed for the diagnosis of parasomnias, the following measurements are obtained: sleep-scoring channels (EEG, EOG, chin EMG); EEG using an expanded bilateral montage; EMG for body movements; and audiovideo recording and documented technologist observations.

Polysomnography for Chronic Insomnia

Evidence at the present time is not convincing that polysomnography in a sleep disorder clinic for chronic insomnia provides definitive diagnostic data or that such information is useful in patient treatment or is associated with improved clinical outcome. The use of polysomnography for the diagnosis of patients with chronic insomnia is not covered under Medicare because it is not reasonable and necessary.

Polysomnography for Snoring

Polysomnography may be indicated for severe snoring when other evidence of sleep disordered breathing is present

Snoring and nasal obstructive signs and symptoms are not, in and of themselves, indications for polysomnography, however, they may be indications of sleep apnea when other findings are also present.

Coverage of THERAPEUTIC services in a sleep disorder clinic

Sleep disorder centers may at times render therapeutic as well as diagnostic services. Therapeutic services may be covered in a hospital outpatient setting or in a freestanding facility provided they meet the pertinent requirements for the particular type of services, are reasonable and necessary for the patient.

Pursuant to 42 CFR 410.32(a), diagnostic tests that are not ordered by the beneficiary's treating physician are not considered reasonable and necessary. Pursuant to 42 CFR 410.32(b), diagnostic tests payable under the physician fee schedule that are furnished without the required level of supervision by a physician are not reasonable and necessary.

Coverage Limitations

Diagnostic testing that is duplicative of previous sleep testing, to the extent the results are still pertinent, is not covered if there have been no significant clinical changes in medical history since the previous study.

Polysomnography, cardiorespiratory sleep studies, and MSLTs are not covered in the following situations:

• For the diagnosis of patients with chronic insomnia;
• To preoperatively evaluate a patient undergoing a laser assisted uvulopalato-pharyngoplasty without clinical evidence that obstructive sleep apnea is suspected;
• To diagnose chronic lung disease (Nocturnal hypoxemia in patients with chronic, obstructive, restrictive, or reactive lung disease is usually adequately evaluated by oximetry. However, if the patient’s symptoms suggest a diagnosis of obstructive sleep apnea, polysomnography is considered medically necessary);
• In cases of typical, uncomplicated, and noninjurious parasomnias when the diagnosis is clearly delineated;
• For patients with epilepsy who have no specific complaints consistent with a sleep disorder;
• For patients with symptoms suggestive of the periodic limb movement disorder or restless leg syndrome unless symptoms are suspected to be related to a covered indication.

Screening tests, in the absence of associated signs, symptoms or complaints will be denied.

Effective for dates of service on or after March 13, 2008, Medicare will allow for coverage of CPAP therapy based upon a diagnosis of OSA by home sleep testing.

CPAP for adults is covered when diagnosed using a clinical evaluation and a positive:

• PSG performed in a sleep laboratory; or
• unattended home sleep monitoring device of type II; or
• unattended home sleep monitoring device of type III; or
• unattended home sleep monitoring device of type IV, measuring at least 3 channels

Peformance of home sleep testing is limited to FDA approved devices furnished with adequate patient instruction and support to assure successful completion and reliable results. Provision of the device, patient instruction and support can be provided by sleep centers, physicians, and Independent Diagnostic Testing Facilities who can demonstrate use of FDA approved devices, inspection of the devices, and the patient education and support necessary.

Diagnostic Tests and X-Rays

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.

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.

N/A

All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient’s medical record and available to the contractor upon request.
   
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
   
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.

The clinic must maintain a record of the attending physician's order/referral.

The medical record must document signs and symptoms to support reasonable and necessary indications for performing a sleep study and must be available to Medicare upon request. These signs or symptoms include, but are not limited to:

• daytime somnolence
• witnessed apneic episodes
• reports of sleeping/napping during the day
• falling asleep at work or when driving
• witnessed nocturnal motor activity (flailing)

A detailed patient history of sleep disorder (as noted), as well as a detailed physical exam, specifically noting at least:

• nose, throat, pharynx exam;
• cardio-vascular exam;
• neurological exam; AND
• general exam, body habitus and weight, vital signs.

In addition, the functional limitations related to sleep disturbance must be clearly documented in the patient's record.

The necessity for diagnostic testing should be confirmed by medical evidence, e.g., patient history and physical examinations.

Medical record documentation must be supplied to the contractor as indicated in the "Indications and Limitations of Coverage" section of this policy and/or as requested.

For a study reported as a polysomnogram, sleep must be recorded and staged.

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Expected utilization of sleep testing is provided in the "Indications and Limitations and/or Medical Necessity" section of this policy. If additional nights of testing are claimed, documentation to support the medical necessity of the additional tests should accompany the claims.

CMS Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2), released March 13, 2008.

AARC-APT (American Association of Respiratory Care-Association of Polysomnography Technologists) clinical practice guideline. Polysomnography. Respir Care. 1995 Dec;40(12):1336-43.

Boehlecke B. Controversies in monitoring and testing for sleep-disordered breathing. Curr Opin Pulm Med. 2001 Nov;7(6):372-80.

Chesson AL Jr, Ferber RA, Fry JM, Grigg-Damberger M, Hartse KM, Hurwitz TD, Johnson S, Kader GA, Littner M, Rosen G, Sangal RB, Schmidt-Nowara W, Sher A. The indications for polysomnography and related procedures. Sleep. 1997 Jun;20(6):423-87. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Kushida CA, et.al. Practice Parameters for the Indications for polysomnography and Related Procedures: Update 2005. Sleep, Vol. 28, No. 4, 2005.

Littner M, Johnson SF, McCall WV, Anderson WM, Davila D, Hartse SK, Kushida CA, Wise MS, Hirshkowitz M, Woodson BT. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep. 2001 Jun 15;24(4):451-66. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Manser RL, Rochford P, Pierce RJ, Byrnes GB, Campbell DA. Impact of different criteria for defining hypopneas in the apnea-hypopnea index. Chest. 2001 Sep;120(3):909-14.

(No authors listed) Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep.1999 Aug 1;22(5):667-89.

Thorpy MJ. et al. The Clinical Use of the Multiple Sleep Latency Test. Sleep. 1992 Jun;15(3):268-76. (Endorsed by American Academy of Sleep Medicine www.aasmnet.org/practiceparameters.htm)

Watanabe T, Kumano-Go T, Suganuma N, Shigedo Y, Motonishi M, Honda H, Kyotani K, Uruha S, Terashima K, Teshima Y, Takeda M, Sugita Y. The relationship between esophageal pressure and apnea hypopnea index in obstructive sleep apnea-hypopnea syndrome. Sleep Res Online. 2000;3(4):169-72.

Other Contractors' policies

Highmark Medicare Services Contractor Medical Directors 

05/15/2008

05/23/2008

L27530

07/31/2008

There are no attachments for this LCD.