Sleep landscape: An open letter to Marilyn Tavenner

Dear Ms. Tavenner: I write this letter based on my experience as the executive director of the American Sleep Apnea Association from May 2004 to March 2014. The opinions and recommendations expressed here are my own and not those held by the association.

During my tenure at the association, significant changes have come about in health care, in general, and for obstructive sleep apnea (OSA) in particular. The decision to allow for physician payment for prescription of positive airway pressure (PAP) therapy on the basis of a diagnostic sleep study done in the home of the patient has the potential to allow many more people—estimates are that 85% of 12 million to 18 million remain undiagnosed—to avoid the barrier of access to and the higher cost of in-lab polysomnography. I testified in 2004 and 2007 before CMS in support of out-of-center testing, as well as had a letter to the editor published in the Journal of Clinical Sleep Medicine on the subject.

The drafting of the national coverage decision to reflect this change in CMS policy was an opportunity to reform how OSA is managed. Like diabetes, OSA is a chronic disease and requires management to insure adherence. The opportunity was missed, however, and unintended consequences have resulted in additional expense to Medicare, both for OSA and overall healthcare costs.

The provision extending coverage beyond the first 90 days “for those beneficiaries diagnosed with OSA whose OSA improves as a result of CPAP during this 12-week period” places an undue burden on the patient and the provider to meet the “outcome” standard of using the therapy a minimum of four hours per night 70% of the nights in the first 90 days. Challenges to adapting to therapy due to pressure settings or mask fit or other issues could and have resulted in failure. Failure means denying therapy or starting the diagnostic process over again. This means added expense and the risk of the patient not restarting therapy due to frustration. Building in the requirement and a mechanism for follow-up during the first 90 days would significantly reduce the number of patients lost to therapy.

Competitive bidding

I can understand the decision, from an economic point-of-view, of including PAP therapy under competitive bidding—it ranked high on the list of expensive therapies provided to Medicare beneficiaries—but unlike all of the items with the exception, perhaps, of a wheelchair used for complex rehabilitation, PAP devices require more instruction than just how to plug it in. Providing the equipment at the lowest price does not necessarily mean the best level of service to the sleep apnea patient, especially those newly diagnosed.

Like the 90-day rule for continued therapy, patients are likely to become frustrated with difficulties associated with resupply and other aspects of maintaining treatment and quit.

While excluding PAP therapy from competitive bidding would be ideal, it is unlikely to happen. H.R. 4920, a bill that would, among other things, require providers to obtain bid bonds as part of future rounds of competitive bidding, would go a long way toward ensuring that OSA patients receive the appropriate services from providers committed to providing services.

Bundled payment model

Simple is certainly better in most things and providing DME providers a bundled payment for services for PAP therapy should simplify managing the equipment needs of the patient. But, to ensure the DME can provide the services over and above just the equipment, namely “the necessary information and instruction on how to use…” referenced in the National Coverage Determination 240.4, it can't be the lowest price provided by bidders in the CBA.

If the proposed rule (CMP1614-P) is adopted, I would encourage the definition of “services” to be expanded to include follow up on education for use of therapy and provisions for substitution of masks for within the estimate of monthly cost.

Closing thought

Just recently, legislation was proposed (H.R.5183) that would pilot the use of value-based insurance design (V-BID) in several regional Medicare Advantage programs to reduce beneficiary cost-sharing for selected high-value prescription medications, providers and clinical services related to chronic disease care.

I would respectfully suggest that when considering V-BID that treatment of OSA be included. There is substantial medical evidence to support that treating OSA can reduce the cost of healthcare by mitigating the cost of treating comorbidities.

Edward Grandi is the former executive director of the American Sleep Apnea Association. He can be reached at efgrandi@gmail.com.