New Medicare CPAP Guidelines Effective April 1, 2002

Medicare Reviews CPAP Coverage

The U.S. Office of Clinical Standards and Quality, at the Centers for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration (HCFA) is reviewing Medicare coverage for Continuous Positive Airway Pressure (CPAP).

Several organizations interested in sleep, including the National Sleep Foundation and the American Academy of Sleep Medicine (AASM), among many others, submitted a letter of support, authored by the American Academy of Sleep Medicine (AASM). The letter asked that proposed coverage standards replace the current policy, which is a restrictive definition of sleep apnea.

The current policy is based on the apnea-hypopnea index (AHI). The AHI uses a per-hour basis to determine eligibility. It counts the combination of apneas (a complete or an almost complete cessation of airflow for 10 seconds or more) and hypopneas (an abnormal respiratory event lasting at least 10 seconds and resulting in reduced airflow and blood-oxygen desaturation) that occur, per hour, for the determination.

AASM recommends Medicare coverage for CPAP when there is an AHI equal to or greater than five per hour, the definition used in the NIH Sleep Heart Health Study, which, along with prospective results of the Wisconsin Sleep Cohort Study, found a clear association between sleep-disordered breathing and the development of hypertension.

AASM is specifically challenging several issues in current Medicare coverage. The first challenge is to have the current Medicare requirement of 30 episodes of apnea with no allowance for hypopneas removed, saying it is a disadvantage to patients who primarily experience hypopneas, but who experience significant sleep disturbance and disability.

The AASM letter also argued "coverage for CPAP should be allowed for patients with apneas, and patients with obstructive hypopneas, since both events have similar pathophysiologic results. Most private insurers, including managed care organizations recognize hypopneas in their criteria for CPAP coverage."

In its letter to CMS officials, the AASM argued the requirement for a minimum of six hours of recorded sleep should be removed. The AASM said this requirement could also prove to be a disadvantage to many patients with poor sleep during the initial sleep study, as well as in the a sleep study when nasal CPAP is initiated after several hours of sleep.

Another point raised by the AASM is that CMS should be removed the current definition of moderate or severe apnea which says surgery is a likely alternative treatment. The AASM argued that the current definition "is totally inconsistent with current sleep medicine practices and should be removed."

Details of the Medicare Decision Tracking Sheet
Medicare Coverage Policy ~ Decisions
Continuous Positive Airway Pressure (CPAP) Therapy Used in the Treatment of Obstructive Sleep Apnea (OSA) (#CAG-00093A)
Tracking Sheet

Issue

HCFA is reviewing the use of CPAP for the treatment of OSA to determine if the national coverage guidelines should be revised. CPAP is a non-invasive technique for providing low levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in OSA. The current diagnostic criteria for OSA require the documentation of at least 30 episodes of apnea, each lasting a minimum of 10 seconds, during 6-7 hours of recorded sleep. The use of CPAP is covered under Medicare when used in adult patients with moderate or severe OSA for whom surgery is a likely alternative to CPAP.

Background

We have received inquiries from manufacturers, clinicians, professional associations and groups, expressing concerns and requesting changes in the national coverage policy for CPAP in the treatment of OSA. We have been informed that the national coverage policy criteria for establishing the diagnosis of OSA are inconsistent with current diagnostic techniques and standards.

There is also some discussion over the definition and significance of partial cessation of breathing (hypopneas). The medical necessity criteria may be too narrow, e.g., surgery is not the option it once was, hypopnea is more widely used and accepted as a diagnostic criteria.

We have been asked to revise the national coverage policy for CPAP to include BiPAP, as well as the diagnostic criteria for OSA to include consideration for hypopneas in the diagnosis of patients with moderate or severe obstructive sleep apnea.

We are seeking any clinical trials, or other medical literature that would assist in revising the current national coverage policy.

Benefit Category:
§1861(n) Durable Medical Equipment

Requestor(s) Name:
Durable Medical Equipment Regional Carriers (DMERCs)

Date of Request:
June 4, 2001

Current Due Date:
September 4, 2001

Lead Analyst(s):
Francina Spencer
(410) 786-4614

Medical Officer:
Joseph Chin, MD
(410) 786-4371