To: Administrative File: CAG-00052N
Respiratory Assist Devices (RADs) with Backup for Chronic Obstructive Pulmonary Disease (COPD) Patients
From: Sean Tunis, MD, MSc
Director, Coverage and Analysis Group
John Whyte, MD, MPH
Acting Director, Division of Items and Devices
Health Insurance Specialist, Division of Items and Devices
Health Insurance Specialist, Division of Items and Devices
Program Evaluation Officer, Division of Items and Devices
Madeline Ulrich, MD
Medical Officer, Division of Items and Devices
Subject: National Coverage Decision
Date: June 29, 2001
This memorandum serves four purposes: (1) describes briefly COPD and respiratory assist devices (RADs); (2) reviews the history of Medicare's coverage policy on RADs;(3) analyzes the scientific and clinical literature relating to RADs, and (4) delineates the reasons for maintaining contractor discretion on RADs for COPD patients.
RADs provide noninvasive positive pressure respiratory assistance (NPPRA). Note that some studies in the literature refer to this as noninvasive positive pressure ventilation (NPPV).
Description and Background of COPD and RADs
COPD is a heterogeneous group of slowly progressive diseases, including both emphysema and chronic bronchitis. COPD, which is most frequently associated with a history of smoking, may be asymptomatic in its early stages. Once symptoms become apparent, they frequently include chronic cough and dyspnea. It is the fourth leading cause of death in the U.S.
Exacerbations of COPD, mainly the result of viral or bacterial infection, may cause increased sputum production, and marked hypoxemia and hypercapnia with a concurrent need for oxygen supplementation. Exacerbations can progress to acute respiratory failure, requiring hospitalization and respiratory support. As COPD progresses, respiratory failure may become chronic even in the absence of an acute event, making intermittent respiratory support useful in ameliorating the long-term effects of prolonged hypoxemia and hypercapnia.
NPPRA is the administration of positive air pressure, using a nasal and/or oral mask interface which creates a seal, avoiding the use of more invasive airway access. It may sometimes be applied to assist insufficient respiratory efforts in the treatment of conditions that may involve sleep-associated hypoventilation. It is distinguished from the invasive ventilation administered via a securely intubated airway, in a patient for whom interruption or failure of respiratory support leads to death.
The codes for the RADs in this discussion are K0532 (without backup) and K0533 (with backup). A RAD without backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs. A RAD with backup rate differs in that it has a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.
Patients with restrictive thoracic disorders, which may make it impossible to spontaneously expand the thoracic cage to take an adequate breath, may sometimes require the NPPRA with backup rate. COPD does not predominantly involve restriction of thoracic cage movement. Thus, the rationale for providing respiratory assistance with backup is not due to a restrictive airway, but rather the impact of hypoventilation, secondary to supply/demand imbalance, predisposing to chronic respiratory muscle fatigue.
History of Medicare's Coverage Policy on RADs
Section 60-9 of the Medicare Coverage Issues Manual provides that ventilators are "covered for treatment of neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease. This includes both positive and negative pressure types." There are no national coverage guidelines on RADs specifying criteria for meeting the conditions for its intended use.
The National Association for Medical Directors of Respiratory Care (NAMDRC) hosted a multi-disciplinary consensus conference addressing specific applications for NPPRA in February 1998. The conference was convened to more clearly discern the appropriate indications for these devices. There had been a marked increase in utilization of NPPV, specifically for patients with COPD and patients with obstructive sleep apnea (OSA), who were unable to use continuous positive airway pressure (CPAP) machines. The overview of the consensus conference stated:
"Currently, there are no controlled randomized clinical data available on the benefits of NPPRA on COPD subjects or on the selection criteria for patients who are most likely to benefit from ventilation therapy. There also is controversy concerning the role of formal sleep studies in identifying subjects and monitoring treatment. Additional research studies and clinical trials are imperative for selection of appropriate candidates and to determine outcomes and cost effectiveness of noninvasive positive pressure ventilation in patients with COPD."
Despite the lack of data, participants believed there were some populations of patients that could benefit from this therapy. As a result, they attempted to find some agreement and therefore developed through consensus the following clinical indicators for use of NPPRA in patients with COPD:
1. Disease documentation:
- Before considering a COPD patient for NPPRA a physician with skills and experience in NPPRA must establish and document an appropriate diagnosis on the basis of history, physical examination and diagnostic tests and ensure optimal management of COPD with such treatments as bronchodilators, oxygen when indicated, and optimal management of other underlying disorders (such as performing a multi channel sleep study to exclude associated sleep apnea if clinically indicated).
- The most common obstructive lung diseases would include chronic bronchitis, emphysema, bronchiectasis and cystic fibrosis.
2. Indications for use:
- Symptoms (such as fatigue, dyspnea, morning headaches, etc.) and
- Physiologic criteria:
- PaCO2≥ 55 millimeters of Mercury (mm Hg)
- PaCO2 50-54mm Hg and nocturnal desaturation (SpO2)≤ 88% for five continuous minutes while on oxygen therapy ≥ 2 liters/minute
- PaCO2 50-54mm Hg and hospitalization related to recurrent ≥ 2 in a 12 month period) episodes of hypercapnic respiratory failure
Based on this information, the Durable Medical Equipment Regional Carriers(DMERCs) developed a regional medical review policy (RMRP) for RADs effective October 1, 1999. (As previously indicated, RADs are to be distinguished from the invasive ventilation administered via a securely intubated airway, in a patient for whom interruption or failure of respiratory support leads to patient's death). For a RAD to be covered under the RMRP, the treating physician must fully document in the patient's medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc. RADS used to administer NPPRA therapy are covered for those patients with the following clinical disorder group: (1) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (2) severe chronic obstructive pulmonary disease, (3) central sleep apnea (CSA), and (4) OSA.
In addition to the above required clinical disorders, the RMRP for RADs used for COPD patients requires that the patients also meet all of the following criteria:
- An arterial blood gas carbon dioxide reading (PaCO2), done while awake and breathing the patient's usual FIO21, is ≥ 52 mm Hg, and
- Sleep oximetry demonstrates oxygen saturation ≤ 88% for at least five continuous minutes, done while breathing the patient's usual FIO2, and
- Prior to initiating therapy, obstructive sleep apnea (and treatment with continuous positive airway pressure) has been considered and ruled out.
If all of the above criteria for patients with COPD are met, a RAD without backup will be covered. A RAD with backup will not be covered for a patient with COPD during the first two months, because therapy with a RAD without backup with proper adjustments of the device's settings and patient accommodation to its use will usually result in sufficient improvement without the need of a backup rate.
For COPD patients who qualified for a RAD without backup, if at a time no sooner than 61 days after initial issue and compliant use of a RAD without backup, the treating physician believes the patient requires a RAD with backup, the RAD with backup will be covered if all of the following criteria are met:
- an arterial blood gas PaCO2, repeated no sooner than 61 days after initiation of compliant use of the RAD without backup, done while awake and breathing the patient's usual FIO2, still remains ≥ 52mm Hg;
- a sleep oximetry, repeated no sooner than 61 days after initiation of compliant use of a RAD without backup, and while breathing with the RAD without backup, demonstrates oxygen saturation ≤ 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient's usual FIO2 (whichever is higher);
- a signed and dated statement from the treating physician, completed no sooner than 61 days after initiation of the RAD without backup, declaring that the patient has been compliantly using the RAD without backup (at least an average of 4 hours per 24 hour period) but that the patient is NOT benefiting from its use;
- a Medicare beneficiary statement completed by the patient no sooner than 61 days after initiation of the RAD without backup documenting that specified coverage criteria have been met.
The RMRP reflected all but one of the recommendations of the consensus conference, with exception of use of the device for severe COPD patients. Industry representatives and others expressed concern with the prerequisite trial waiting period of NPPRA ventilation without backup before use of a noninvasive ventilation with a backup for COPD patients. We have received inquiries from manufacturers, clinicians, and professional associations and groups, expressing concerns and requests for changes in the regional medical review policy for NPPRA used for patients with severe COPD.
On February 17, 2000, we announced our intent to review the current policy regarding use of RADs in COPD applications and if necessary develop a national coverage policy. Throughout the past year, we have met with representatives of the Coalition of Respiratory Care Manufacturers and the American Association for Homecare, NAMDRC, industry groups, and patients on numerous occasions.
The Coalition requested that the scope of this review be more narrowly defined to include a small subgroup of very severely ill COPD patients, who require RAD with backup rate. In subsequent meetings and conversations, they proposed the following criteria:
"For group II patients (COPD), a K0533 ventilator will be covered without the need for completion of a prerequisite trial with a K0532 device if the following criteria are met: 1) During a hospitalization for acute hypercapnic respiratory failure (PaCO2≥ 52mm Hg), the patient requires treatment with a ventilator using backup rate to maintain clinical stability. Evidence would include worsening hypercapnia, acidosis, or increased respiratory distress while the patient uses a ventilator without a backup rate at the usual FIO2 or persistent oxygen desaturations less than 90% for at least 10% of recording time (minimum 2 hrs), and 2) The patient fails to respond adequately during the prerequisite period using a K0532 device, as evidenced by worsening daytime hypoventilation (i.e increased PaCO2 decreased pH, or recording time, (minimum 2 hr) despite use of the K0532 device and functional status or sustained nocturnal oxygen desaturations (<90% for > 10% of the usual FI02."
In addressing the issue of the role of RAD and the need for a backup rate for patients with severe COPD, the following analytic question arises:
Is there evidence that demonstrates that severely ill COPD patients should have direct placement on a RAD with backup rate without first having a trial of a respiratory assist device without a backup rate;
Despite an exhaustive literature search and review of all literature submitted by the requestors, we were unable to find any studies directly relating to this analytic question. Most of the articles found were limited to evaluations of devices, defining COPD exacerbation, the conditions of patients best suited for respiratory assistance, and portability studies (which devices were suited for home use vs. institutional use, ease of use, suitability for patients, etc.). A few recent studies are noteworthy in that they also emphasize the need for additional research in this area.
Criner at al (1999) evaluated the acute and chronic effects of NPPV on gas exchange, functional status, and respiratory mechanics in patients with chronic respiratory failure related to COPD or restrictive ventilator disorders. 2 NPPV was initiated in a noninvasive respiratory care unit geared toward the evaluation and treatment of NPPV and followed patients after discharge in a comprehensive outpatient program in order to maximize compliance with chronic NPPV therapy. He concluded that "future studies, preferably conducted in a prospective, randomized, and controlled fashion, are required to determine the subgroups of COPD patients who may best benefit from NPPV therapy." As noted earlier, this article does not include comparisons of the use of RADs with and without backup, nor does it offer criteria, which could be used to determine whether a backup rate is needed by any specific group of COPD patients.
Casanova et al (2000) attempted to determine one-year efficacy of NPPV added to long-term oxygen therapy in patients with severe COPD.3 The authors randomized 52 patients with severe COPD (FEV1 < 45%) to either NPPV plus standard care, or to standard care alone. Outcomes measured included rates of acute COPD exacerbations, hospital admissions, intubations, and mortality at 3,6,and 12 months. At the conclusion of the study, there were no differences in mortality, number of acute exacerbations, or number of hospital admissions.
Hillberg et al (1997) published a review article, finding that patients most likely to benefit from noninvasive ventilation are those with acute or chronic respiratory failure. 4 Noninvasive ventilation can be used as maintenance therapy in patients with intrinsic lung disease and marked hypercapnia (e.g. partial pressure of carbon dioxiode greater than 60 mm Hg). Short- term use of this therapy for a few hours per day improves the respiratory pattern and blood gases in patients with stable COPD who have chronic hypercapnia. Long-term use of NPPV has been shown to be beneficial in some hypercapnic patients with COPD but he did not show that NPPV with backup is used for severe COPD patients.
Jones et al (1998) stated that there is increasing interest in the use of non-invasive nocturnal intermittent positive pressure ventilation (NIPPV) in the management of patients with chronic hypercapneic respiratory failure. 5 Although this treatment enables patients requiring mechanical ventilatory support to be treated more readily at home, few studies have been done to demonstrate its long term benefits in COPD and the application of NIPPV in these circumstances remains controversial.
In theory, there may be a small subset of severely ill COPD patients who need a RAD with backup, and therefore be exempt from a prerequisite trial. Despite an exhaustive search of the medical (scientific and clinical) literature, we were unable to identify the small subset of severely ill COPD patients who would conclusively need RAD with back-up rate. There were no studies that compared health outcomes between patients treated with RAD with backup, versus without backup. In addition, the criteria proposed by the Coalition relate to acute episodes that are hospital based. It is difficult to determine what a patient needs at discharge based on what he/she presented with upon/during admission. As a result, we will maintain contractor discretion. We would be interested in revisiting this issue in 1-2 years, or as additional information becomes available about the immediate need for a backup rate. Given the lack of data and clinical consensus, we will not make a national coverage decision at this time. Contractor discretion allows the contractors to make individual coverage determinations, including exceptions. We invite interested parties to share information with us and the carriers concerning appropriate study designs and outcome measures.
No national decision warranted. Contractor discretion.
1 FIO2 is the fractional concentration of oxygen, delivered to the patient for inspiration. For the purpose of the DMERC RMRP, the patient's usual FIO2 refers to the oxygen concentration the patient normally breathes when not undergoing testing to qualify for coverage of NPPRA therapy.
2 Criner GJ, Brennan K, Travaline JM, and Kreimer D. Efficacy and compliance with noninvasive positive pressure ventilation in patients with chronic respiratory failure. Chest 1999;116:667-675.
3 Casanova C, Cecil B, Tost L, et al. Long-term controlled trial of nocturnal nasal positive pressure ventilation in patients with severe COPD. Chest 2000;118:1582-1590.
4 Hillberg, Robert E.; Johnson, Douglas C. Current Concepts: Noninvasive Ventilation. New England Journal of Medicine 1997; 337: 1746-1752.
5 Jones, S.E.; Packham, S.; Hebden, M; Smith AP. Domiciliary nocturnal intermittent positive pressure in patients with respiratory failure due to severe COPD: long term follow up and effect on survival. Thorax 1998;53:495-498.