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NAMDRC Legislative and Regulatory Agenda Once Again Focuses on Patient Access


 

NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.


Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

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