A technical expert panel (TEP) on optimal noninvasive ventilation (NIV) issued recommendations for improved access to noninvasive ventilation for certain Medicare patients by updating CMS’s national coverage determinations (NCDs) for NIV.
The panel, conducted by the American College of Chest Physicians, the American Academy of Sleep Medicine, the American Association for Respiratory Care, and the American Thoracic Society, lay out considerations to revise NCDs for NIV use in patients with thoracic restrictive disorders (TRD), COPD, and hypoventilation syndromes (HS).
Current NCDs were formulated in 1998, the panel noted. However, “new original research, updated formal practice guidelines, and current consensus expert opinion have accrued that are in conflict with the existing NCDs,” they wrote in an executive summary published with the recommendations in Chest. They also added that technology advancements warrant a revision of the existing NCDs. “Thus, these and related NCDs relevant to bilevel positive airway pressure for the treatment of obstructive sleep apnea (OSA) and central sleep apnea (CSA), need to be updated to ensure the optimal health of patients with these disorders,” they wrote.
According to the organizations, the panel was convened in response to the ongoing and growing concern that lifesaving equipment is being denied payment because of rigid criteria in local coverage determinations and that the existing coverage provided by CMS is not reflective of rapidly evolving technology in the field. “In an effort to remove these regulatory barriers and support coverage of necessary medical equipment, stakeholders initiated a patient-focused advocacy initiative for respiratory care called the Optimal NIV Medicare Access Promotion (ONMAP).
“CMS was wanting rigorous scientific support necessary to clarify the ‘reasonable and necessary’ role of these new mechanical therapeutic modalities where there was none in order to move forward,” said Peter C. Gay, MD, MS, FCCP, HPAC committee member. “What we have done is create a pathway to simplify the maze of regulation and perhaps most importantly, remove the obstacles that currently exist.”
The published reports in Chest will support a formal request for review of the CMS coverage determinations for the delivery of NIV therapy to Medicare beneficiaries. The five focus areas are designed to enable access to improved treatment for people suffering from a broad range of disorders, including (1) thoracic restrictive disorders, (2) COPD, (3) central sleep apnea, (4) hypoventilation syndromes and (5) Obstructive Sleep Apnea (OSA).
“We were able to gather the top experts in all of these fields who could summarize the best evidence. And, more importantly, we identified ways that current coverage was hindering the ability to get the right device to the right patient at the right time,” said Robert Owens, MD, HPAC committee member.
Patients who are paired with the right medical device experience a better quality of life and better management of their condition. These patients are often medically fragile, so timing and streamlined approvals are critical.
The organizations will file a formal NCD reconsideration for improved NIV access in each of the five focus areas. If deemed necessary, the rules governing the reconsideration process include an opportunity for public comment.
“We encourage all involved parties to read the published journal reports and be prepared to advocate for these necessary changes. For this to be successful, we need the support of the membership of each of the organizations, representatives from patient advocacy groups and all of the clinicians whose patients are impacted by the present restrictions to access to durable medical equipment,” said Steven Q. Simpson, MD, FCCP, President of Chest.
