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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.
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:
September 8, 2020
Posted follow up information.
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
8:20 - 8:35 AM
8:35 – 9:20 AM
9:20 – 9:50 AM
9:50 – 10:05 AM
10:05 – 11:05 AM
Public attendees, who have contacted the MEDCAC Coordinator prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.
11:05 – 11:30 PM
11:30 – 12:30 PM
12:30 – 1:30 PM
1:30 – 2:30 PM
2:30 – 2:45
2:45 – 3:45 PM
3:45 – 4:10 PM
4:10 – 4:30 PM
Download meeting minutes
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.
The types of NIPPV devices being referred to in the below questions are to be used in the home and are classified as:
All questions below pertain to Medicare beneficiaries with CRF consequent to COPD.
Discussion: If intermediate confidence (≥ 2.5) is present in Q1, please provide the selection criteria for the specific category of equipment.
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.
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.
Discussion: If intermediate confidence (≥ 2.5) is present in Q4, please provide the patient usage criteria for the specific category of equipment.
Peter Bach, MD, MAPP
Attending Physician & Director
Center for Health Policy and Outcomes
Memorial Sloan-Kettering Cancer Center
Joseph Ross, MD, MHS
Medicine and Public Health
Section of General Internal Medicine
Department of Medicine
Yale University School of Medicine
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
St. Elizabeth Hospital
Anita Fernander, PhD, ABPBC
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
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
Human Research Protections Program
Research Integrity Officer
Human Protections Administrator
University of Indianapolis
Joy Melnikow, MD, MPH
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
Division of Geriatrics & Clinical Gerontology
National Institute on Aging
National Institute of Health
Laura Mauri, MDVice PresidentGlobal Clinical Research and AnalyticsMedtronic
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
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
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
Joseph Chin, MDDeputy DirectorCoverage and Analysis Group
Tara HallCoverage and Analysis Group
Medicare Evidence Development & Coverage Advisory Committee
July 22, 2020
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