Noninvasive Positive Pressure Ventilation in the Home for Chronic Respiratory Failure Consequent to Chronic Obstructive Pulmonary Disease

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=77 | meeting_date=2020-07-22

On July 22, 2020, the Centers for Medicare & Medicaid Services (CMS) will conduct a Virtual Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting. The MEDCAC Panel will review the evidence specific to the home use of noninvasive positive pressure ventilation by patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). Devices to be considered are home mechanical ventilators (HMVs), bi-level positive airway pressure (BPAP) devices and continuous positive airway pressure (CPAP) devices. We are seeking the MEDCAC’s recommendations regarding the characteristics that define patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD. The MEDCAC will specifically focus on the scientific evidence associated with the outcomes most pertinent to the affected patient population. Outcomes of interest will include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, increased time to hospital re-admission for respiratory related disease, and improved function and quality of life. MEDCAC panels do not make coverage determinations, but CMS benefits from their advice.

Actions Taken: June 10, 2020 CMS posts MEDCAC meeting announcement. Posted questions to panel. July 15, 2020 Posted agenda , roster and speaker list for meeting. Also posted presentations and written comments/background materials . July 21, 2020 To view Virtual MEDCAC meeting please register below: Registration September 8, 2020 Posted follow up information. Meeting Minutes Transcript Scoresheet WebEx recording Morning Block: https://letsmeet.webex.com/letsmeet/lsr.php?RCID=a4762e1c44258f28f4b968f56b075c20 Password - jKNSX6dB Afternoon Block: https://letsmeet.webex.com/letsmeet/lsr.php?RCID=1b41a19fb0d01c25a580537cf632c95c Password - BmKBi3kS Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee July 22, 2020 8:00 AM - 4:30 PM Virtual Meeting Peter Bach, MD , Committee Chair Joseph Ross, MD , Committee Vice-Chair Joseph Chin, MD , Deputy Director, Coverage and Analysis Group Tara Hall , MEDCAC Coordinator 8:00 - 8:20 AM Opening Remarks - Tara Hall/ Joseph Chin, MD /Peter Bach, MD 8:20 - 8:35 AM CMS Presentation - Rachel Katonak, PhD, RN 8:35 - 9:20 AM Michael Wilson, MD - Assistant Professor of Medicine Mayo Clinic Evidence Based Practice Center, Mayo Clinic Division of Pulmonary and Critical Care Medicine Issue: On July 22, 2020, the Centers for Medicare & Medicaid Services (CMS) will conduct a Virtual Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting. The MEDCAC Panel will review the evidence specific to the home use of noninvasive positive pressure ventilation by patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). Devices to be considered are home mechanical ventilators (HMVs), bi-level positive airway pressure (BPAP) devices and continuous positive airway pressure (CPAP) devices. We are seeking the MEDCAC’s recommendations regarding the characteristics that define patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD. The MEDCAC will specifically focus on the scientific evidence associated with the outcomes most pertinent to the affected patient population. Outcomes of interest will include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, increased time to hospital re-admission for respiratory related disease, and improved function and quality of life. MEDCAC panels do not make coverage determinations, but CMS benefits from their advice. Minutes: Download meeting minutes Other Material: Transcript 1 Panel Voting Questions: Download scoresheet . Medicare Evidence Development & Coverage Advisory Committee Home Use of Noninvasive Positive Pressure Ventilation in Patients with Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD) July 22, 2020 Chronic obstructive pulmonary disease (COPD) is a progressive disease that can cause acute and chronic respiratory failure which interferes with the ability to breathe. Its prevalence is common in the Medicare population. Respiratory failure is a condition that may be treated with various methods, both pharmacologic and non-pharmacologic. In certain individuals, noninvasive positive pressure ventilation (NIPPV) may be safely provided in the home to improve the clinical condition. For the administration of such treatment, it is possible to choose from a selection of equipment that for the purposes of Medicare, may be broadly classified into three categories: home mechanical ventilators (HMVs), bi-level positive airway pressure (BPAP) devices and continuous positive airway pressure (CPAP) devices. The Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Durable Medical Equipment (DME) Reference List (280.1) states that ventilators may be covered for neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure (CRF) consequent to COPD. However, when necessary, each of these diseases may also be treated with other types of respiratory equipment. The choice of an appropriate treatment plan, including the determination to use a ventilator versus a bi-level or CPAP device, is made based upon the specifics of each individual beneficiary's medical condition. Currently, there is substantial variability regarding the prescribing patterns, guidelines and policies for these types of devices. Yet, the inappropriate prescription of such devices in those who have need can lead to clinical deterioration, poor quality of life and ultimately death. Therefore, the Centers for Medicare and Medicaid Services is conducting a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel to examine the scientific evidence pertaining to the use of various types of NIPPV equipment in order to assess the characteristics that define the patient selection criteria, usage parameters, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD. Voting Questions: For each voting question, please use the following scale identifying your level of confidence with a score of 1 being low or no confidence and 5 representing high confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence The types of NIPPV devices being referred to in the below questions are to be used in the home and are classified as: Home mechanical ventilator (HMV): A machine capable of delivering pressure targeted, volume targeted, and/or volume preset ventilation outside of the hospital setting. HMVs are usually the machine of choice for patients with tracheostomy, but may also be used in patients via a noninvasive interface. Compared to BPAP machines, HMVs typically have additional monitoring, ventilator control, safety, and backup power features. Continuous positive airway pressure (CPAP): A machine that delivers a single level of positive airway pressure throughout the entire respiratory cycle (inspiration and expiration). Bi-level positive airway pressure (BPAP): A device that delivers two levels of positive airway pressure. On inspiration, the machine delivers an inspiratory positive airway pressure (IPAP). On expiration, the machine delivers an expiratory positive airway pressure (EPAP). All questions below pertain to Medicare beneficiaries with CRF consequent to COPD. How confident are you that the evidence is sufficient to determine the patient selection criteria that will improve health outcomes (e.g. laboratory values, co-morbidities, frequency of exacerbations requiring ER or hospital admission, hospital discharge timing, pulmonary function tests, etc.) when used with any category of home NIPPV device? Discussion: If intermediate confidence (≥ 2.5) is present in Q1, please provide the selection criteria for the specific category of equipment. How confident are you that the evidence is sufficient to determine the NIPPV equipment parameters necessary to promote successful patient-related outcomes (e.g. decreased mortality, decreased frequency of exacerbations requiring ER or hospital admission, increased time to hospital re-admission for respiratory related disease, and improved physical function and quality of life)? Discussion: Are there any outcome measures that should be considered other than those noted above? Discussion: If intermediate confidence (≥ 2.5) is present in Q2, please provide the equipment parameters for the specific category of equipment. How confident are you that any improved patient-related outcomes noted above made with any type of NIPPV device in the home, can be attributed to the use of the equipment alone as opposed to the concomitant provision of other support services like home respiratory therapists, home medication reconciliation and repeated elective hospital admissions? Discussion: If intermediate confidence (≥? 2.5) of improved patient-related outcomes are present in Q3 for any type of home NIPPV device, please state that outcome and the associated category of equipment. How confident are you that the evidence is sufficient to provide the patient usage parameters that are necessary to achieve the successful patient outcomes in Q2? Discussion: If intermediate confidence (≥ 2.5) is present in Q4, please provide the patient usage criteria for the specific category of equipment. Roster: Committee Chair Peter Bach, MD, MAPP Attending Physician & Director Center for Health Policy and Outcomes Memorial Sloan-Kettering Cancer Center Committee Vice-Chair Joseph Ross, MD, MHS Associate Professor Medicine and Public Health Section of General Internal Medicine Department of Medicine Yale University School of Medicine MEDCAC Members Timothy J. Barreiro, DO, MPH, FCCP, FACOI Professor of Internal Medicine, Northeast Ohio Medical University Clinical Professor of Critical Care Medicine Ohio University Heritage College of Osteopathic Medicine Pulmonary Health & Research Center Mercy Health St. Elizabeth Hospital Anita Fernander, PhD, ABPBC Associate Professor Director of Graduate Studies Chair, Lexington Fayette-County Health Disparities Coalition Department of Behavioral Science College of Medicine University of Kentucky Michael J. Fisch, MD, MPH, FACP, FAAHPM National Medical Director Medical Oncology AIM Specialty Health Melissa M. Garrido, PhD, BS Research Associate Professor Department of Health Law, Policy & Management Boston University School of Public Health Research Health Science Specialist Partnered Evidence-Based Policy Resource Center (PEPReC) Boston VA Healthcare System Kim Kuebler DNP, APRN, ANP-BC Director, Multiple Chronic Conditions Resource Center Medical Team Leader, Ortho-Sport and Spine Physicians Adjunct Graduate Nursing Faculty Greg Manship, DBe, Mdiv, MA Director Human Research Protections Program Research Integrity Officer Human Protections Administrator University of Indianapolis Joy Melnikow, MD, MPH Professor Department of Family and Community Medicine School of Medicine University of California, Davis Lawrence J. Ellison Ambulatory Care Carla Perissinotta, MD, MPH Associate Professor of Medicine School of Medicine University of California, San Francisco - Due to unforeseen circumstances, Dr. Perissinotta is unable to attend the meeting. Marcel Salive, MD, MPH Medical Officer Division of Geriatrics & Clinical Gerontology National Institute on Aging National Institute of Health Industry Representative Laura Mauri, MD Vice President Global Clinical Research and Analytics Medtronic Guest Panel Members Gerard J. Criner, MD, FACP, FACCP Chair and Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University Director, Temple Lung Center Peter C. Gay, MD Professor of Medicine Consultant Pulmonary, Critical Care, Sleep Medicine Mayo Clinic American College of Chest Physicians American Academy of Sleep Medicine Neil MacIntyre, MD Professor of Medicine Duke University Medical Center Invited Guest Speakers John M. Coleman III, MD Assistant Professor Division of Pulmonary & Critical Care Medicine Northwestern University Feinberg School of Medicine Michael E. Wilson, MD Assistant Professor of Medicine Mayo Clinic Evidence Based Practice Center Mayo Clinic Division of Pulmonary and Critical Care Medicine CMS Liaison Joseph Chin, MD Deputy Director Coverage and Analysis Group MEDCAC Coordinator Tara Hall Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee July 22, 2020 SPEAKER LIST *8 MINUTES PER SPEAKER* Robert Owen, MD , Associate Professor of Medicine at University of California San Diego Representing: The American Thoracic Society Carlos Nunez, MD , Chief Medical Officer (CMO) of ResMed Lisa Wolfe, MD , CHEST - Health Policy and Advocacy Committee, Associate Professor of Medicine and Neurology, Northwestern University, Chicago Illinois, Feinberg School of Medicine William D. Frazier MD, FCCP , Chief Medical Officer of VieMed Kunwar Praveen Vohra, MD, MBA, FAASM, FCCP , Chair, Payer Policy Review Committee American Academy of Sleep Medicine Gregory A. Holt, PhD RRT FAASM , Diplomate, American Board of Sleep Medicine Director of Operations and Polysomnography