ATLANTA--In the latest development on PAP testing and policy, last week the four DME MACs delayed the Sept. 1 implementation date of their recent local coverage determinations on positive airway pressure devices.
“In July, the DME MACs published an LCD on PAP devices for obstructive sleep apnea. Some criteria in that policy were to take effect for dates of service on or after Sept. 1. All criteria with a Sept. 1, 2008, implementation date are being delayed,” read an announcement from the MACs.
Following CMS' national coverage determination on coverage of sleep therapy--issued March 13--which opened the door for home sleep testing, HME providers were caught off guard when the MACs’ LCD prohibited them from conducting HSTs. And while the LCD offered policy clarification, it also included additional restrictions on coverage criteria that raised questions, notably a 12-week patient compliance requirement.
Among other stakeholders, the American Association for Homecare sent an 11-page comment letter to the four MAC jurisdiction medical directors Aug. 14 asking for a delay in implementation of the policy because the LCD “makes extensive and substantive revisions to the existing LCD for PAP devices, including new conditions of coverage,” the association said, adding:
“AAHomecare’s concern is that the new PAP LCD was published without a comment period even though it contains significant new and detailed coverage criteria that restrict access to PAP therapy and limit who is eligible to furnish diagnostic test interpretations, which are Medicare-covered services.”
Excerpts of AAHomecare’s letter follow:
“The new LCDs were published in July 2008 with an implementation date of Sept. 1, 2008, and make extensive and substantive revisions to the existing LCD for CPAP devices. Specifically, the policy adds new conditions of coverage, including medical necessity criteria without identifying the research sources on which the new coverage criteria are based. The LCD also limits the types of physicians eligible to furnish Medicare-covered services and creates unnecessary hurdles to care for Medicare beneficiaries requiring treatment with PAP devices. We are requesting that the four DME MACs substantially revise the LCD to address our concerns and open the new LCD for public comments so that all stakeholders who are affected by the new policy have an opportunity to comment. We also request a delay in the implementation of the policy in all four DME MAC jurisdictions to ensure that physicians and HME suppliers are educated on the new policies and have sufficient time to achieve compliance for the benefit of their patients ...
"It also seems as though the rule strategically picks and chooses when a supplier can and cannot provide clinical and diagnostic data. For example, the rule requires the HME supplier to obtain [data] for proof of adherence and therefore payment but is prohibited from participating in the initial diagnostic home sleep test ... Patient services will suffer due to the confusion and contradictions of who is responsible for what regarding the differences between the DME MAC LCDs and the NCD."
Items in the LCD originally published with the Sept. 1 effective date that are now subject to the delay include:
--The requirements of the face-to-face clinical evaluation by
the referring physician required to include history, Epworth and
physical exam including BMI;
--Face-to-face demonstration of the portable testing device by the
entity performing the test, not a DME;
--Sleep tests must be read by an MD boarded by AASM or ABMS or by
an active employee of a JCAHO or AASM accredited sleep lab or
center;
--Continuing coverage of the PAP device beyond 90 days requires a
new face-to-face evaluation by the MD;
--Continuing coverage also requires, by direct download, objective
compliance measurement of 4 hours or more for 70 percent of the
nights (21) in a consecutive 30-day period within the first 90
days; and
--Criteria for switching to RAD device within and after the 90-day
trial. RAD requirements in effect prior to 9/1/08 will apply.
According to the MAC announcement, “A revised LCD will be
published in the near future and will include a new effective date
for those criteria.”
