On Sept. 18, 2008, the Centers for Medicare and Medicaid Services issued a revised policy in regard to an earlier Local Coverage Determination for positive airway pressure devices for the treatment of obstructive sleep apnea. Some portion of this new policy will affect all providers of PAP therapy in one form or another.
The following summarizes these changes and what you as a provider must now adhere to in order to be in compliance.
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CMS now requires that in order for PAP coverage to continue after 90 days, a follow-up face-to-face visit with the treating physician must occur.
The treating physician must document that symptoms of OSA have improved as a result of PAP therapy and compliance to utilizing the therapy is evidenced. This face-to-face visit must occur between the 31st and 91st day from the initiation of therapy.
This is an expansion of time from between the 61st and 91st day as outlined in the initial LCD. Documentation of compliance does not have to accompany the claim but must be available if requested.
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Documentation of compliance benefitted from the most recent CMS LCD revision. Compliance can now be accomplished through visual inspection through the use of the hour meter as well as direct download.
This documentation must be put in a written format and submitted to the treating physician. Prior to this revision, downloadable PAP devices were the only option, so now providers are not forced to buy the more expensive devices. However, being able to document from an hour meter that compliance was at least four hours per night is difficult to ascertain, so further clarification is needed.
In order for coverage to continue, the time of PAP usage must be ≥ 4 hours per night on 70 percent of the nights during a consecutive 30-day period anytime during the first three months of usage. The use of these parameters is troubling as they are based on the Kribbs study published in 1993.
Subsequent research such as that from Patricia Lloberes, MD, et al, “Predictive Factors to Quality of Life Improvement and Continuous Positive Airway Pressure use in Patients with Sleep Apnea-Hypopnea Syndrome” states: “Although increased use of CPAP could be presumed to produce greater improvement, our results suggest that regular users of CPAP achieve benefits despite the number of hours of CPAP use, since patients using CPAP for ≥ 4h or ≤ 4 h showed a similar [quality of life] and somnolence improvement. The minimum therapeutic usage of CPAP remains unknown.”
As a result, the American Association for Homecare is asking CMS why the Kribbs study is being used as the benchmark for coverage when subsequent studies suggest favorable outcomes are achieved based on a usage of less than four hours.
When it has been determined that the PAP device was tried and found to be ineffective during the initial three-month home trial, substitution of a respiratory assist device can be tried. This does not require a new physician visit or sleep test. If this substitution occurs with less than 30 days remaining during the trial period, the clinical evaluation must occur before the 120th day following the initiation of PAP therapy to document adherence to therapy.
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Another change as a result of the most recent LCD is in the calculation of the AHI or RDI.
Previously, two hours of continuously recorded sleep was required that demonstrated an AHI or RDI of 15 or more events per hour or an AHI or RDI of between 5 and 14 with documented related symptoms.
The revised coverage allows for less than two hours of continuous sleep as long as the total number of recorded events used to calculate the AHI or RDI is at least the number of events that would have been required in a two-hour period. As before, the documentation must reflect > 30 events without symptoms or > 10 events with symptoms.
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The new LCD also prohibits payment to “a supplier or its affiliate that is directly or indirectly the provider of the sleep test used to diagnose a beneficiary with OSA.” CMS goes on to say “… the individual or entity that directly or indirectly administers the sleep test and /or provides the sleep test device used to administer the test has a self-interest in the result of that test if that provider, or its affiliate, is also the supplier of the CPAP device.”
As the LCD stands now, direct ownership of a sleep lab by a DMEPOS supplier would result in the PAP referral being prohibited, and also puts hospital-based HME providers who accept referrals from their hospital's diagnostic sleep lab in jeopardy.
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Regarding home sleep studies, the newly revised LCD as it reads now basically takes home medical equipment providers out of the market. No aspect of a home sleep test, including but not limited to delivery and pick up of the device, may be performed by an HME provider.
In addition, any patient instruction as to the use of portable sleep monitoring devices must be provided by the entity conducting the HST and may not be performed by the HME provider.
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Finally, interpretation of all HSTs must be interpreted by a physician who holds either:
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Current certification in sleep medicine by the American Board of Sleep Medicine (ABSM); or
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Current subspecialty certification in sleep medicine by a member board of the American Board of Medical Specialties (ABMS); or
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Completed residency or fellowship training by an ABMS member board and has completed all requirements for subspecialty certification in sleep medicine except the examination itself and only until the time of reporting of the first examination for which the physician is eligible; or
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Active staff membership of a sleep center or laboratory accredited by the American Academy of Sleep Medicine (AASM) or the Joint Commission.
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As with the initial issue of most LCDs, questions and concerns arise. Clarifications are being asked for, and revisions are likely forthcoming. However, what is abundantly obvious is that CMS does not want HME companies involved in any way with home sleep testing.
Bob Hoffman, RRT, is director of the VGM Group's Nationwide Respiratory alliance for respiratory providers. Formerly, Hoffman was founder and manager of Allen Memorial Hospital's Medical Equipment Services in Waterloo, Iowa. He also developed an HME business for Waterloo's Covenant Medical Center, owned an HME company and was a hospital staff RT. Hoffman has a Bachelor of Arts degree in business management from St. Cloud State University in Minnesota and graduated from the Mayo Clinic School of Respiratory Therapy. You can contact him at bob.hoffman@vgm.com.
