Perspectives From TEP Participants

FEBRUARY 2021

Perspectives From TEP Participants

From Robert Owens, MD, and Peter Gay, MD, FCCP: Patients who require noninvasive ventilation are medically complex and struggle with severe nocturnal sleep-disordered breathing disorders. Unfortunately, clinicians who care for such patients often face additional hurdles when trying to get patients the ventilator devices they need and regulations have not been updated to reflect new science and technologic advances.

In addition to noninvasive ventilation for COPD and neuromuscular disease, the panel also addressed patients with obesity-related hypoventilation, CPAP-intolerant obstructive sleep apnea, and central sleep apnea. While the TEP members were the expert clinicians, the summit also included viewpoints from representatives of industry and durable medical equipment companies who provided valuable input, and it was attended by members from CMS.

The overarching goal is to formulate recommendations that will allow the “right device to the right patient at the right time.” The TEP has met regularly to continue to refine its ideas and policies, which we hope will ultimately influence payors via updated national coverage determinations. Our executive summary and constituent documents are being drafted and will be reviewed for publication shortly. While focused on ventilation for a variety of disorders, the structure and purpose of the TEP may be a model for future advocacy and change.

From the American Association for Homecare: AAHomecare appreciates CHEST’s leadership in bringing together clinician and respiratory therapy stakeholders to develop policy recommendations for home-based noninvasive ventilators (NIV). The presentations and discussion at the October 2020 Technical Expert Panel on NIV demonstrated the high degree of clinical knowledge and commitment to improving standards of patient care of the groups involved in the process. AAHomecare supports efforts to reach a durable consensus on policies to ensure the best outcomes for patients utilizing NIV or other respiratory therapies. We believe that such policies should: 1) be driven by patients’ needs over cost considerations; 2) maintain a single NCD for NIVs; 3) include clear and objective clinical criteria for using NIV, including specific testing criteria for beneficiaries to qualify for NIV therapy and separate criteria for utilizing other treatments; and 4) employ a uniform Clinical Data Elements (CDE) format to capture objective criteria for treatment. AAHomecare looks forward to continuing to work with CHEST and the organizations sharing their expertise to the benefit of individuals who require respiratory support.

From the Council for Quality Respiratory Care: CQRC appreciates CHEST’s efforts to provide clinical guidance to physicians prescribing access to noninvasive ventilators (NIV) to patients. As the pandemic has demonstrated, patient access to NIV is essential to protect patients and address public health infrastructure challenges. This clinical clarity should support individualized shared decision-making between physicians and patients and avoid cost considerations. Any coverage decision should be developed in partnership with patients, suppliers, caregivers, and manufacturers, as well, to ensure that documentation requirements do not create barriers to patient access. CQRC believes coverage criteria should be:

• Clearly defined and based on objective, clinically appropriate tests.
• Avoiding “tried and failed” language, so patients do not endure ineffective treatments.
• Practical to obtain and not limited to a single care setting.
• Avoiding requiring physicians sharing patient medical records with the government.
• Not including “usage” requirements but permitting flexibility to meet individual patient needs.
• Addressing noninvasive ventilators and respiratory assist devices separately.

From ResMed: ResMed sincerely appreciates CHEST’s convening of this Technical Expert Panel to develop clinical consensus recommendations on noninvasive ventilation outside of the hospital. CHEST’s willingness to lead this discussion and gather a distinguished group of physicians, stakeholders, and industry leaders to tackle these issues is vital to protect patient access and drive improved quality of care in the home. We relay our utmost thanks to the panel and co-chairs, Drs. Peter Gay and Robert Owens, for the invitation to participate in this robust discussion, and reiterate our support for policies that are not administratively burdensome, maintain objective criteria, and enable physician flexibility and clinical decision making. ResMed looks forward to the continued partnership between patients, suppliers, clinicians, and manufacturers as we work to ensure patients have access to the right device at the right time, as determined clinically appropriate by their physician.

From Hillrom: Hillrom appreciates the opportunity to provide feedback on this important coverage development process. We value the transparency, inclusion of diverse perspectives, and the careful consideration of critical factors impacting patients and relevant stakeholders. We acknowledge the important role we play in the revision process of current CMS regulations for home mechanical ventilation. As both a medical device manufacturer and a direct patient provider, Hillrom’s input throughout this process was intended to provide technical and regulatory considerations, as well as real-world experience in the utilization of noninvasive ventilation at home. Our recommendations were rooted in evidenced-based clinical practice, clinical studies, and patient experiences. With the overarching goal of improving patient care for all, our hope is that consideration is also given to those patients with specific clinical and lifestyle needs where specific therapy modalities, such as mobile noninvasive ventilation, are also included.

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