Under current Medicare law and regulations, the Center for Medicare and Medicaid Services (CMS) has a confusing mix of rules that is complicated to understand and certainly contrary to the current standards of practice. Earlier this year, NAMDRC, CHEST, and about a dozen other societies wrote to CMS citing problems:
• Medicare does not recognize FDA classifications of devices as ventilators. Therefore, while one agency within the Department of Health & Human Services is specifically charged with the responsibility for determining safety and efficacy of medical devices and providing strict rules for labeling, a sister agency in the same department is not bound to accept those determinations. This has the effect of CMS stating that “just because FDA calls a device a ventilator does not make it a ventilator.”
Phil Porte
This bizarre scenario is undoubtedly tied to a current statute that requires CMS to pay for certain ventilators under the “frequent and substantial servicing” payment methodology rather than the “capped rental” payment methodology. If CMS believes it might pay too much for home mechanical ventilators, it simply says that the worrisome device is actually a “respiratory assist device,” a term it has created for payment purposes.
• In 2001, CMS issued a Decision Memo that has the effect of signaling that in order to receive home mechanical ventilation, there must be the presence of an artificial airway AND removal of the device would lead to death. This principle is fraught with problems from various perspectives. First, even though the memo explicitly states “contractor discretion,” the key Medicare contractors have repeatedly signaled they have no flexibility and must adhere to that principle.
Secondly, with the advent of noninvasive mechanical ventilation, CMS created codes for processing such devices through the payment system, even though the 2001 Decision Memo refers to the need for an artificial airway. The inconsistency in these policies have led to confusion from ordering physicians and suppliers as well.
• Now, in 2015, the state-of-the-art of home mechanical ventilation is a world apart from 2001, and no policies have been updated related to home mechanical ventilation. Respiratory assist devices (RADs) or bilevel devices to everyone except Medicare recipients, are part of the problem. Because access to RADs are covered by very strict, inflexible Medicare rules, physicians and suppliers often find it easier to prescribe a ventilator for treatment of respiratory failure.
Possible solutions: Crafting solutions might seem relatively easy, but we want to ensure that rules we might agree to today need to be flexible enough to address innovations 2, 3, or 5 years from now. Therefore, the pathway of a national coverage determination (NCD) might not be the best approach because once an NCD is set into policy, it is a challenging effort to modify it, even if CMS agrees that problems with the relatively new policy need adjustment. Therefore, NAMDRC is working with other societies to craft some important principles and shape those principles into new policies that CMS could adopt outside of the NCD framework. Those principles include the following:
• A specific definition of “respiratory failure” that can be used to guide physicians, suppliers, and payers. Under this principle, if a diagnosis of respiratory failure meets the clinical definition and the physician certifies the medical necessity of treating respiratory failure, part of the treatment plan, by definition, includes a home mechanical ventilator.
• We see little need to distinguish between invasive and noninvasive home mechanical ventilation for coverage purposes. The principle outlined in the 2001 Decision Memo is outdated and no one genuinely believes that, by definition, the most critically ill must have a trach in order to survive. Let the physician determine the best approach; and in the case of many patients, particularly in the neuromuscular arena, a patient might use invasive mechanical ventilation nocturnally and noninvasive ventilation at other times. Importantly, most devices today can accommodate either approach.
• CMS’s RAD policy should be reshaped to provide greater flexibility to ensure that bilevel devices are available to those patients where less intensive therapy is appropriate.
We are hopeful that a revamped set of policies could be in place by the end of the year or early in 2016.