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

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

July 15, 2020

July 21, 2020

September 8, 2020

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

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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.

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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

Download scoresheet.

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:

1. 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.
2. Continuous positive airway pressure (CPAP): A machine that delivers a single level of positive airway pressure throughout the entire respiratory cycle (inspiration and expiration).
3. 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.

1. 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.

2. 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.

3. 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.

4. 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.

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

• 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