In late August, the American Academy of Sleep Medicine (AASM) indefinitely suspended the requirement for accredited sleep centers to score hypopneas according to the 3% oxygen desaturation criterion.
The AASM continues to recommend scoring hypopneas using the 3% criterion. However, it is acceptable for accredited sleep centers to score hypopneas using an oxygen desaturation criterion of 4%. AASM-accredited sleep centers must document in the patient’s record whether hypopneas were scored using an oxygen desaturation criterion of 3% or 4%.
The new manual’s hypopnea scoring rule has significant changes, including the criterion that there “is a more than or equal to 3% oxygen desaturation from pre-event baseline or the event is associated with an arousal.” However, the coverage policies of a number of insurance payers, including Medicare, continue to require an oxygen desaturation of more than or equal to 4% when scoring hypopneas.
Payers can deny payment or deny patients their therapeutic equipment if documentation doesn’t comply with their requirements for diagnostic testing. Therefore, it is critical for sleep centers and DME suppliers to document compliance with payer requirements.
The AASM Board of Directors recognizes that it would be a significant burden for accredited sleep centers to be required to score sleep studies twice, using both the 3% and the 4% hypopnea desaturation criteria. Therefore, the AASM is suspending indefinitely the requirement for AASM-accredited sleep centers to score sleep studies using the 3% hypopnea criterion. This change is effective immediately.
“Any time a rule is changed, it causes some concern from an industry perspective because we have to modify our products to conform with a rule,” says Richard Bonato, PhD, president and CEO, Braebon Medical Corp, Ottawa, Canada. “We must follow strict government procedures that comply with FDA software development guidelines.
“The difficulty with the application of that particular rule is that the insurance payors were not on board,” continues Bonato. “So you have a clinical organization making one regulation, and another requirement from insurance payors, which presents a challenge to industry to balance the two.”