Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD

I agree with the position and comments provided by SuperCare Health

The current policy limits access to ventilators for COPD patients and restricts physicians from making individualized decisions based on patient-specific needs. This highlights the pressing need for a revision in policy that better serves COPD patients. Ensuring consistent care across all DME MAC regions is essential for delivering equitable treatment. An updated NCD is vital to preserve access to necessary therapies, as managing high-acuity COPD patients at home greatly reduces healthcare costs and resource burdens. This access should be protected by revising the NCD, rather than leaving it up to the discretion of local MACs through LCD policies.

In response to the TEP recommendations for NCD 280.1, I offer the following points of support and concern:

Areas of Support:

I fully support eliminating pulse oximetry studies from the qualification criteria for home mechanical ventilation with or without supplemental O2.
Prescribing clinicians should have the authority to determine the timing of respiratory therapy initiation, especially in cases involving COPD and Chronic Respiratory Failure (CRF).
For COPD patients, eliminating the requirement for sleep studies to rule out obstructive sleep apnea (OSA) is critical.
I also support establishing separate coverage for respiratory therapist (RT) services provided in the home.
It's important to include criteria for coverage of HMV (NIV) to account for alarms, batteries, service needs, mouthpiece ventilation, and multiple preset therapy modes.

Areas of Concern:

Requiring an ABG of PaCO2 >52 mmHg to confirm COPD is too restrictive. A PaCO2 >45 mmHg should define hypercapnia, aligning with NIH guidelines.
The recommendations do not adequately explore alternative methods like End-Tidal CO2 (EtCO2), Transcutaneous CO2 (TcCO2), or Venous Blood Gas (VBG), which are becoming more common in clinical practice.

The requirement to "consider" OSA and CPAP therapy for COPD and CRF patients is unnecessary and may lead to delays in care. Prescribing physicians need the flexibility to use clinical judgment, especially in cases like "Overlap Syndrome," where patients have both COPD and sleep-disordered breathing.
The criteria for initiating HMV (NIV) should be determined solely by the patient's physician and based on the patient's specific condition. Recommendations that equate higher therapy pressures with greater disease severity are inappropriate, as effectiveness often relies more on device modes and synchronization features than pressure levels alone.
Metrics like oxygen flow (FIO2 >40% or 5 L/min nasally) should not be considered in the context of HMV (NIV) initiation, as COPD is primarily a ventilatory issue, not an oxygenation issue.
Lastly, the requirement for 10 hours of ventilator use per day is arbitrary. Usage duration should not limit access to necessary therapy, as decisions must be based on the physician’s assessment of the patient's needs.

Additional Comments/Recommendations:

I support separate reimbursement for clinical services provided to COPD patients in the home, as current Medicare coverage does not account for these services. The criteria for accessing ventilators should not be overly burdensome, as this would likely extend patient hospital stays and create barriers to timely care. Diagnostic criteria should not rely solely on ABG testing; other measures such as VBG, ETCO2, TcCO2, and relevant PFTs should be considered to provide a more comprehensive evaluation.
This policy revision is necessary to ensure that COPD patients receive appropriate care and that clinicians are empowered to make the best decisions for their patients' health and well-being.

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Thanks to all the everyone that weighed in on this issue.
The past 10 years we have perfected our care of our COPD population using Non-invasive ventilation (NIV) with Home Mechanical Ventilation (HMV). We are an integrated health system (6 hospitals in 2 states), so readmission rates matter to us as a DME. We all know that there appears to be a certain amount of the “set it and forget it mentality” with (HMV) that could end with bad outcomes, over utilization and fines. Through trial and error, we have devised a roadmap to ensure appropriate care and patient success.
Our quick facts
Admission requirements are similar to the ONMAP criteria
Patients admitted to our COPD NIV program have less than a 2% readmission rate to any hospital for the 8+ years we have been tracking our outcomes
Medicare, Medicaid and Insurance reap the benefits of fewer to no ER visits, ICU stays etc.
RTs help under-served patients get services to stabilize living conditions and/or services of palliative care team or hospice when that point is reached again keeping them out of the hospital
Stops patients from using ER for their healthcare which usually contributes to stabilizing their condition
Our patients report better quality of life,
Our patients that do not tolerate CPAP or BiPAP describe it as having your head out a car window on the highway. When HMV is applied the patients describe it as a gentle breeze assisting their breath. This population would have been in the ER or admitted.
Better Understanding of HMV modes by insurance and CMS that HMV modes are not CPAP and BiPAP. Modes are proprietary and this leads to confusion for CMS and insurance as to what the physician is ordering. CPAP, BiPAP and HMV are not interchangeable. We as a company battle that confusion daily when we send settings on our ventilator that is taken as BiPAP. Our PSSV mode is an HMV setting with all the sophisticated settings of any ICU ventilator with alarms batteries etc.
In closing we hope that CMS will use ONMAP criteria as well as clear up confusion over equipment and modes of ventilation

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As the Chairs and on behalf of the members of the TEP group that authored the document providing the basis for the current reconsideration of the NCD regarding chronic obstructive pulmonary disease (COPD), we want to thank CMS for this opportunity to comment on this most important National Coverage Analysis (NCA). Evidence first provided by the MEDCAC meeting of July 2020 and later within the ONMAP TEP Chest Sept 2021 COPD section publication made clear the need for some straightforward alterations to the current coverage policy. It has been a long process during which time, we remain most concerned that many Medicare beneficiaries were not provided reasonable and necessary care that in fact clearly improves survival. The national experts from the TEP along with several prominent medical societies including the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society are all in agreement with the following recommendations of the TEP:

1) Patients where COPD is the predominant condition causing stable hypercapnia should have direct access to RAD devices with a backup rate (E0471), and NOT be required to first try and fail the use of an E0470 device.

2) The requirement to undergo overnight oximetry to document hypoxemia prior to qualifying for RAD therapy should be completely abandoned. There was no clear scientific rationale to document hypoxemia in a patient with significant hypercapnia nor was this part of any inclusion criteria for the studies provided by the TEP supporting evidence.

Aspects of health disparities and equity are notably overlooked when additional and unnecessary testing is added for patients with limited availability, no ease of access, and technical difficulties augmenting disparities in care access and only serve as an inequitable barrier to coverage.

In the real world, COPD patients often have mixed problems of heart failure, obesity with hypoventilation, or perhaps even mild OSA. It is not necessary to create multiple vignettes and descriptors for need of less sophisticated devices (E0470- BPAP without a backup rate or E0601- CPAP) in the COPD patient with sufficient hypercapnia (> 52 mmHg) and severity of COPD if the treating physician can (and should) clearly document the following: “Severe COPD is the predominant condition accounting for the need of an E0471 device.” The appropriateness of this choice would be further reinforced by the 61-90 day follow-up visit whereby it is further documented: “The patient sees benefit from continued use and is using the device the required amount of time to satisfy continued reimbursement.”

The most striking and contentious component of the NCD over the years has been the obvious difficulty in defining the hypercapnic COPD patient severe enough to require a home mechanical ventilator (HMV). The current coverage system has continued with an archaic reimbursement criterion focused nearly exclusively on the presence of a preset volume mode. The criteria should more appropriately include a clear description of the most severe patient characteristics requiring more sophisticated equipment with necessary frequent and substantial servicing. The TEP made concerted efforts to outline both aspects of the device and the patient needs that better identify those beneficiaries in need of an HMV (those meeting any of the below criteria):

1. Daytime use
2. Inspiratory pressure higher than deliverable by E0471
3. Need for Fraction of inspired oxygen (FiO2) >40% or 5 liters/min nasally
4. Ventilator support for 10 hours per day or greater (i.e., daytime use), or the use of mouthpiece ventilation
5. Both sophisticated alarms and accompanying internal battery (high-dependency patient)
6. Persistence of hypercapnia with PaCO2 > 52 mm Hg despite adequate adherence to E0471 BPAP therapy

After the TEP publications were provided in 2021, further discussions with thought leaders and medical society leadership members have made evident that there are 2 most typical patient vignettes to describe the patient in need of an HMV. The most severe acute hypercapnic COPD patient initially presents during hospitalization for an episode of hypercapnic respiratory failure. Patients in need of direct access to HMV do not initially come to the attention of their physician in the outpatient setting. The acute on chronic respiratory failure patients are rescued with ventilator equipment in the ICU and then are attempted to be optimized during the hospitalization with RAD equipment. Some of these patients will fail a short-term trial of NIV with a RAD device with a backup rate in the hospital and either rapidly deteriorate or clearly fail to meet their therapeutic goals after several days as documented by the treating physician. Clearly, the patient hospitalized for hypercapnic respiratory failure with persistent hypercapnia, despite an attempt with an E0471 device in hospital, will need an HMV at time of discharge.

The second most typical avenue of presentation for the most severe chronic hypercapnic COPD patient is when they either require NIV for long hours (>10 daily), or requiring NIV during the day perhaps including mouthpiece support or their hypercapnia worsens despite adequate treatment with an E0471. Without an HMV with alarms or battery backup, and monitoring that allows careful and sophisticated ventilator setting adjustments, they are now at risk for severe clinical deterioration and prolonged repeated hospitalizations.

We again are very grateful for your attention to these issues which have too long been a severe burden standing in the way of optimal access to NIV therapy for Medicare patients with severe COPD to provide the ‘right device for the right patient at the right time.’

Peter C. Gay MD and Robert L. Owens, MD

Chairs, Technical Expert Panel for the Optimal NIV Medicare Access Promotion (ONMAP)

References:

1) Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive Summary: Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021 Nov;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074. Epub 2021 Jul 30. PMID: 34339685

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Introduction: Respire Home Medical Services is a company comprised of 4 regional DME suppliers that provide specialized services for patients with complex respiratory conditions (Med Emporium, Advent Home Medical, Life Tech, and AeraTech). We are writing to provide comments on Non-Invasive Positive Pressure Ventilation (NIPPV) in the home for the treatment of Chronic Respiratory Failure consequent to COPD [CAG-00465N]

Request: We urge CMS to hold off on making changes to the current NCD policy for coverage of NIPPV for patients with chronic respiratory failure (CRF) resulting from COPD until the DME MASs complete their review of the LCD for respiratory assist devices.

Points to consider:

There are reports of current policy creating barriers to the timely provision of these devices and this therapy to patients in their homes and the receipt of the care they require.

Current LCDs should be finalized before the current NCD considerations for ventilators are modified to ensure the two policies work together seamlessly. Doing so would likely create additional barriers to treatment for this vulnerable population, leading to increased morbidity, mortality, and preventable hospitalizations that improve patient care and reduces overall cost of care.

Clinical Concerns:

Trial and failure of lesser devices could and likely will lead to patient harm. What defines failure? Is it a hospitalization, intubation and placement on invasive support, or death? None of these are acceptable outcomes or in the best interest of the beneficiaries.

Consideration for in-home clinical care and monitoring by licensed RTs as required in most states. This clinical service is not otherwise available for patients in their homes and is an important part of the patient’s extended clinical care team.

On call support from the DME provider since these devices are never purchased and owned by the patient. Patients who own their PAP device do not receive 24 hour on-call support following the capped rental period.

There is substantial literature supporting the benefit of advanced therapy for patients with chronic respiratory failure over traditional PAP based therapy.

NIV through a ventilator has become the standard of care since the development of newer technologies that provide near hospital quality ventilation without the need for an invasive airway.

This therapy is dynamic and more comfortable to patients which leads to better adherence to therapy and leads to better outcomes as well as significantly improved quality of life. It provides variable therapeutic support based on monitoring of patient respiratory status and responds to changes as needed but does not require them to try to adapt to maximal support at all times that would be needed on PAP devices to meet worst case needs. By using less support when needs are lower and only adding higher support when needed based on more modern monitoring capabilities patients can be more comfortable and yet receive higher support than is available in PAP devices when needed. They get what they need when they need it, not more than they need when they don’t.

Patients who require ventilatory support benefit from backup battery systems in ventilators that are not available in PAP devices. In some cases, power outages will lead to hospitalization and possible patient harm.

The purpose of the newer technologies in ventilators is to reduce the pressure needed to support the patient. Excessive airway pressure can lead to decreased cardiac output, pulmonary barotrauma, and patient discomfort as discussed above.

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October 11, 2024

Tamara Syrek Jensen
Director, Coverage and Analysis Group Centers for Clinical Standards and Quality
Centers for Medicare & Medicaid Services 7500 Security Blvd.
Baltimore, MD 21244

Re: National Coverage Analysis for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure Consequent to Chronic Obstructive Pulmonary Disease (COPD) (CAG-00465N)

Dear Ms. Syrek Jensen,

On behalf of the Advanced Medical Technology Association (AdvaMed), we are submitting written comments in support of CMS’ decision to initiate a national coverage analysis for Noninvasive Positive Pressure Ventilation (NIPPV in the Home for the treatment of Chronic Respiratory Failure (CRF) consequent to Chronic Obstructive Pulmonary Disease (COPD). Home use of noninvasive ventilation therapy delivered via devices that include home mechanical ventilators (HMVs), bilevel positive airway pressure (BPAP)/Respiratory Assist Devices (RAD) and continuous positive airway pressure (CPAP) devices are important for the treatment of patient with chronic respiratory conditions.

AdvaMed member companies produce the medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. These technologies include those devices indicated to be under consideration in this national coverage analysis, inclusive of those that diagnose and treat sleep apnea, and chronic respiratory conditions like COPD. AdvaMed is committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

When updating the NCD, CMS should consider the need for ongoing support for patients being treated with home NIPPV to provide treatment adjustments to incorporate changes in a patient’s condition. Additionally, AdvaMed believes that CMS’ analysis should consider adding mobility and physical activity to further demonstrate the benefit of NIPPV in Medicare beneficiaries with COPD-induced CRF. COPD is associated with a decline in physical activity, exercise capacity, and lung function that continues to decline as the disease progresses and leads to a vicious cycle of deconditioning, dyspnea, and a further reduction in physical inactivity,[1,2,3,4,5,6,8,9] decreased quality of life[1,2,5,9] and increased mortality.[1,4,5,6,10] Increasing physical activity plays a crucial role in managing all stages of COPD and improving long-term outcomes.[1,3,5,9] Wearing a home mechanical ventilator while doing activity, including the activities associated with daily living, has been shown to improve short-term and long-term exercise tolerance by decreasing the work of breathing, improving oxygenation, decreasing hypercarbia which all ultimately improve the quality of life, and decreasing mortality.[1,9,10,11,12]

When prescribing home mechanical ventilation for the COPD patient, the patient’s level of dyspnea with exertion should also be considered as an important clinical factor as COPD patients with chronic exertional dyspnea may reduce or avoid physical activity, even in the early stages and may benefit from home mechanical ventilation with activity, even for shorter hours.[1,2,3,4,5,6,8,9] NIPPV can be applied during daily walking in addition to being used while at rest or during the night, thus alleviating dyspnea during exertion and maintaining physical activity, which is highly important in severe COPD.[10] An added benefit of a portable home mechanical ventilator that allows patients to wear the ventilator while being mobile inside and outside the home, offering a practical option for increasing activity and exercise tolerance in oxygen-dependent patients with COPD.[7]

The updated NCD needs to not only update the coverage criteria for NIPPV but it also needs to facilitate coverage to ensure equitable access for all eligible Medicare beneficiaries. Based on the Center for Disease Control and Prevention 2023 report on trends in the prevalence of COPD [13], the prevalence of COPD increases with increasing age, decreasing education level, and decreasing urbanicity. The NCD needs to ensure geographic access to NIPPV including rural communities.

AdvaMed is concerned, however, about CMS’ decision to limit the NCD reconsideration to only COPD and not the other important respiratory illnesses, as indicated by the requesting physicians and societies. Further, we respectfully request the agency take into account the interdependency between the current LCD reconsideration for the Bilevels/Respiratory Assist Devices (RADS). Before CMS makes any changes to this NCD, especially considerations of new qualification criteria specific to COPD patients that might create additional barriers without considering revised criteria to access bilevels/RADs, CMS should allow the time necessary to carefully assess the impact. We appreciate that the Coverage Analysis Group (CAG) has limited resources to both update NCDs and develop new NCDs and that a priority is to ensure that Medicare beneficiaries have access to innovative medical technologies. We recommend CMS develop a defined process, separate from reconsideration requests, with timeframes and criteria for revising and reviewing NCDs. This process would enhance CMS’ commitment to improve the transparency of the NCD process.

AdvaMed’s member companies are available to provide any additional information you may need. Please contact me at tburke@advamed.org with any questions. Thank you for the opportunity to submit comments.

Sincerely,

Tara Burke, PhD
Vice President, Payment & Healthcare Delivery Policy
AdvaMed

References
1. Xiang G, Wu Q, Wu X, Hao S, Xie L, Li S. Noninvasive ventilation intervention during exercise training in individuals with chronic obstructive pulmonary disease: a systemic review and meta-analysis. Annals of Physical and Rehabilitation Medicine. 2021;64(6):101460. doi:10.1016/j.rehab.2020.101460.
2. Nici L. Pulmonary Rehabilitation: Mechanisms of Functional Loss and Benefits of Exercise. Respiratory Care. 2023 Jun;68(6):640-50. doi: 10.4187/respcare.11705
3. Hanania NA, O'Donnell DE. Activity-related dyspnea in chronic obstructive pulmonary disease: physical and psychological consequences, unmet needs, and future directions. International Journal of Chronic Obstructive Pulmonary Disease. 2019;14:1127-38. doi:10.2147/COPD.S188141
4. O'Donnell DE, Milne KM, James MD, de Torres JP, Neder JA. Dyspnea in COPD: New Mechanistic Insights and Management Implications. Adv Ther. 2020 Jan;37(1):41-60. Doi: 10.1007/s12325-019-01128-9. Epub 2019 Oct 30.
5. Garcia IFF, Tiuganji CT, Simões MSMP, Santoro IL, Lunardi AC. Systemic effects of chronic obstructive pulmonary disease in young-old adults' life-space mobility. International Journal of Chronic Obstructive Pulmonary Disease.2017;12:2777-85. doi:10.2147/COPD.S146041
6. Celli BR, Cote CG. Predictors of mortality in COPD. Respiratory Medicine. 2010 Jun;104(6):773-9. doi: 10.1016/j.rmed.2009.12.017. Epub 2010 Apr 22.
7. Carlin BW, Wiles KS, McCoy RW, Brennan T, Easley D, Thomashow RJ. Effects of a Highly Portable Noninvasive Open Ventilation System on Activities of Daily Living in Patients with COPD. Chronic Obstr Pulm Dis. 2015;2(1):35-47.
8. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester CL. COPD and exercise: does it make a difference? Breathe (Sheff). 2016;12(2):e38-e49. doi:10.1183/20734735.003916
9. Ou Y, Chen H, Huang K, et al. Efficacy of non-invasive ventilation as a rescue therapy for relieving dyspnea in patients with stable severe COPD. Respir Med. 2016;121:74-80. doi:10.1016/j.rmed.2016.10.010
10. Dreher M, et al. Noninvasive ventilation during walking in patients with COPD: a randomized cross-over trial. Eur Respir J. 2007;29(5):930-936. doi:10.1183/09031936.00075806
11. Gurgun A, et al. The effect of adding noninvasive ventilation to supplemental oxygen during exercise training in severe COPD: a randomized controlled study. Chest. 2015;148(4):909A. Abstract.
12. Marrara K, et al. Noninvasive ventilation as an important adjunct to an exercise training program in subjects with moderate to severe COPD. Respir Care. 2018;63(11):1388-1398.
13. Liu Y, Carlson SA, Watson KB et al. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ? 18 Years – United States, 2011-2021. MMWR Morb Mortal Weekly Rep 2023:72;1250-1256.

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The American College of Chest Physicians (CHEST) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) national coverage analysis (NCA) for Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N). CHEST is a professional medical society representing 22,000 pulmonologists, critical care, and sleep medicine clinicians that seeks to advance the best health outcomes for patients with lung disease through education, advocacy, research, and philanthropy. A key aspect of advancing best health outcomes requires ensuring that our members have confidence that the therapies and interventions they prescribe will be appropriately accessible to their patients without challenge.

It is for this reason that CHEST was a signatory on the September 2021 reconsideration request, which derived its recommendations from the CHEST-convened Technical Expert Panel Report on Optimal NIV Medicare Access Promotion (1). We thank CMS for initiating this national coverage analysis (NCA) in an opportunity to improve patient access to evidence-based treatment, improve health equity, and optimize outcomes in the management of Chronic Obstructive Pulmonary Disease (COPD).

CHEST would request CMS to consider the following comments with regards to this national coverage analysis:

1 - Health Equity: The current national coverage determination (NCD) for noninvasive ventilation (NIV) in COPD requires overnight oximetry saturation = 88% for > 5 minutes with a minimum of nocturnal recording on 2 L/min of supplemental oxygen or the patient’s prescribed level, whichever is higher. This requirement has no medical basis and is not physiologically sound - patients with COPD have persistent hypercapnic respiratory failure with or without supplemental oxygen to treat hypoxemia.

Additionally, recent evidence (2) has shown clear bias in the measurement of oxygen levels with pulse oximetry, overestimating oxygen saturation in patients with darker skin. Including hypoxemia as measured by pulse oximetry as a criterion for NIV for COPD would only serve to exacerbate further inequities in COPD management. Furthermore, many COPD patients that could benefit from NIV may not have access to some of the tests required in the current NCD (e.g., polysomnography, sleep oximetry). We strongly urge CMS to remove the overnight oximetry criterion to prevent further exacerbating disparities in patient care.

2- Interrelation of Devices: As highlighted in the COPD article (3) in the broader report, strongly encourage CMS to consider a comprehensive policy that that ensures patient access to the correct device in a timely manner. Patients with chronic respiratory failure consequent to COPD should be considered for a bilevel positive airway pressure (BPAP) device with backup rate or home mechanical ventilator. There should be no requirement to first trial a BPAP device without a backup rate, as the studies showing benefit of NIV in these patients used BPAP devices with a backup rate. BPAP devices without a backup rate may not provide the necessary ventilatory support to treat the hypercapnic respiratory failure in these patients. Furthermore, patients with severe COPD that require a home mechanical ventilator should have access to these directly without having to first trial devices already known to be incapable of providing the support needed to treat their level of respiratory failure.

3- Pathway: We are aware that DME MACs is currently reviewing the LCDs for respiratory assist devices (RADS) and would encourage CMS to develop a comprehensive policy that ensures patient access to the most effective device based on their individual needs and requirements. The path forward needs to reconsider the system as a whole, integrating the RAD program with the HMV program so there is a more cohesive plan that ensures patients have access to the type of device that will optimize their outcomes. We are concerned that changing the E0466 criteria without updating the current RAD criteria could cause catastrophic inequities and access limitations for the most vulnerable patient populations.

In closing, we thank CMS for responding to the reconsideration request and for working with the community to create a pathway to treatment of chronic respiratory failure consequent to COPD that takes easing current barriers as its goal. At the same time, as acknowledged in the 2021 publication “Executive Summary Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society,”¹ the coverage of NIV for people suffering from other diseases, including thoracic restrictive diseases, hypoventilation syndromes, central sleep apnea, and obstructive sleep apnea remains equally burdensome. CHEST looks forward to collaborating with CMS to ensure the appropriate provision of physician-prescribed devices to all populations who benefit.

(1) Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive Summary: Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021 Nov;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074. Epub 2021 Jul 30. PMID: 34339685
(2) Jamali H, Castillo LT, Morgan CC, et al. Racial Disparity in Oxygen Saturation Measurements by Pulse Oximetry: Evidence and Implications. Ann Am Thorac Soc. Dec 2022;19(12):1951-1964. doi:10.1513/AnnalsATS.202203-270CME
(3) Hill NS, Criner GJ, Branson RD, Celli BR, MacIntyre NR, Sergew A; ONMAP Technical Expert Panel. Optimal NIV Medicare Access Promotion: Patients With COPD: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021 Nov;160(5):e389-e397. doi: 10.1016/j.chest.2021.06.082. Epub 2021 Jul 30. PMID: 34339684

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Areas of Support:

I support the following recommendations outlined in the TEP recommendations:

? Elimination of pulse oximetry studies from any qualification criteria for home mechanical ventilation with or without supplemental O2.

? The prescribing clinician should have the authority to determine the appropriate timing for initiating a specific respiratory therapy device. NIPPV should be based on the discretion of the prescribing clinician where COPD and Chronic Respiratory Failure (CRF) are concerned.

? For patients with a diagnosis of COPD, elimination of the requirement for a sleep study to rule out obstructive sleep apnea (OSA).

? Establishment of separate coverage and reimbursement for respiratory therapist (RT) services provided in the home.

? Inclusion of criteria for coverage of HMV (NIV) when the need for alarms, batteries, service, mouthpiece ventilation, and/or multiple preset prescription therapy modes.

Areas of Concern:

I do not support the following recommendations outlined in the TEP recommendations as they are currently written:

ABG of PaCO2> 52 mmhg to confirm COPD

A PaCO2 of >45 mmHg should be utilized to define hypercapnia, in accordance with NIH guidelines.

The TEP recommendations fail to adequately consider the use of alternative post-acute methods for assessing CO2 levels, such as End-Tidal CO2 (EtCO2), Transcutaneous CO2 (TcCO2), or Venous Blood Gas (VBG). Even in acute care settings, many facilities now prioritize VBG over Arterial Blood Gas (ABG) as a primary measure for patient evaluation.

OSA and CPAP “Considered” Requirement

The diagnosis and management of obstructive sleep apnea (OSA) and the use of CPAP therapy should not be considered relevant for patients with COPD and Chronic Respiratory Failure (CRF). A requirement to “consider” these issues as it relates to the determination to prescribe NIPPV is not for this population should be removed.

The recommendations put forth by the TEP may lead to delays in care or create confusion for prescribing physicians, particularly in cases of "Overlap Syndrome," where a patient is affected by both sleep-disordered breathing and COPD. Such situations require nuanced clinical judgment, and overly rigid guidelines could hinder timely and appropriate treatment decisions.

HMV Consideration Criteria Concerns

Initiation of HMV (NIV) should be solely at the discretion of the patient's physician and aligned with the specific disease burden and progression of the patient. While on the surface the recommendations below make sense, I do not agree with the following recommendations as written for the following reasons:

The formal request does not define the number of clinical criteria for coverage of an HMV (NIV); it should be first at the discretion of the physician, but secondarily to “one or more” of the outlined criteria

Higher pressures than those deliverable by E0471

Equating the pressure settings of a therapy device with the severity of a patient's condition is not appropriate, as higher pressure levels do not necessarily correspond to increased severity of COPD.

The effectiveness of the device may be more influenced by its modes and advanced settings, which enhance synchronization between the device and the patient, as well as the availability of multiple preset therapy modes, rather than by pressure levels alone.

FIO2 higher than 40% or 5 L/min nasally, which is greater than can be supplied by E0471

COPD is a ventilatory issue, not an oxygenation issue. As such, consideration for initiation of HMV (NIV) treatment for COPD should not even take into account oxygen liter flow. While oxygen dependency often goes hand in hand with COPD treatment, it is not an indication of the severity of the ventilator defect. HMV (NIV) is indicated to improve and stabilize gas exchange in COPD patients with chronic respiratory failure. This is a very different clinical strategy compared to prescribing supplementary oxygen which only improves blood oxygen saturation levels but does not improve gas exchange by lowering blood carbon dioxide levels and stabilizing blood pH.

Ventilator support for 10 h per day or greater (ie, daytime use)

The figure of “10 h” per day is a somewhat arbitrary figure that is not clinically supported. The 10 hour metric should not restrict patients who demonstrate less usage from receiving HMV(NIV) should their physician determine it as necessary therapy to address the condition.

Additional Comments/Recommendations:

Clinical Services Reimbursement

I support separate coverage and payment for clinical services in the home for this patient population. At present, however, there is no separate Medicare coverage and payment available to a DME provider for clinical services provided to patients in the home. CMS should consider updating policy to include payment for services associated with the complex and comprehensive management of patients in the home.

Timely Access to Therapy

The criteria should not be so burdensome as to create a barrier that effectively prevents the use of a ventilator and a clinician’s ability to order the ventilation therapy. Burdensome criteria will likely increase patient length of stay, disrupting the discharge process.

Diagnostic Criteria

Clinical and/or acceptance criteria should not be limited to available objective testing such as ABG. Recommend using other measures as well, such as:

VBG, ETCO2, or TcCO2

PFT (with other qualifying indicators – ex. chart notes documenting of Chronic Resp Failure and PFT)

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Areas of Support:

I support the following recommendations outlined in the TEP recommendations:

? Elimination of pulse oximetry studies from any qualification criteria for home mechanical ventilation with or without supplemental O2.

? The prescribing clinician should have the authority to determine the appropriate timing for initiating a specific respiratory therapy device. NIPPV should be based on the discretion of the prescribing clinician where COPD and Chronic Respiratory Failure (CRF) are concerned.

? For patients with a diagnosis of COPD, elimination of the requirement for a sleep study to rule out obstructive sleep apnea (OSA).

? Establishment of separate coverage and reimbursement for respiratory therapist (RT) services provided in the home.

? Inclusion of criteria for coverage of HMV (NIV) when the need for alarms, batteries, service, mouthpiece ventilation, and/or multiple preset prescription therapy modes.

Areas of Concern:

I do not support the following recommendations outlined in the TEP recommendations as they are currently written:

ABG of PaCO2> 52 mmhg to confirm COPD

A PaCO2 of >45 mmHg should be utilized to define hypercapnia, in accordance with NIH guidelines.

The TEP recommendations fail to adequately consider the use of alternative post-acute methods for assessing CO2 levels, such as End-Tidal CO2 (EtCO2), Transcutaneous CO2 (TcCO2), or Venous Blood Gas (VBG). Even in acute care settings, many facilities now prioritize VBG over Arterial Blood Gas (ABG) as a primary measure for patient evaluation.

OSA and CPAP “Considered” Requirement

The diagnosis and management of obstructive sleep apnea (OSA) and the use of CPAP therapy should not be considered relevant for patients with COPD and Chronic Respiratory Failure (CRF). A requirement to “consider” these issues as it relates to the determination to prescribe NIPPV is not for this population should be removed.

The recommendations put forth by the TEP may lead to delays in care or create confusion for prescribing physicians, particularly in cases of "Overlap Syndrome," where a patient is affected by both sleep-disordered breathing and COPD. Such situations require nuanced clinical judgment, and overly rigid guidelines could hinder timely and appropriate treatment decisions.

HMV Consideration Criteria Concerns

Initiation of HMV (NIV) should be solely at the discretion of the patient's physician and aligned with the specific disease burden and progression of the patient. While on the surface the recommendations below make sense, I do not agree with the following recommendations as written for the following reasons:

The formal request does not define the number of clinical criteria for coverage of an HMV (NIV); it should be first at the discretion of the physician, but secondarily to “one or more” of the outlined criteria

Higher pressures than those deliverable by E0471

Equating the pressure settings of a therapy device with the severity of a patient's condition is not appropriate, as higher pressure levels do not necessarily correspond to increased severity of COPD.

The effectiveness of the device may be more influenced by its modes and advanced settings, which enhance synchronization between the device and the patient, as well as the availability of multiple preset therapy modes, rather than by pressure levels alone.

FIO2 higher than 40% or 5 L/min nasally, which is greater than can be supplied by E0471

COPD is a ventilatory issue, not an oxygenation issue. As such, consideration for initiation of HMV (NIV) treatment for COPD should not even take into account oxygen liter flow. While oxygen dependency often goes hand in hand with COPD treatment, it is not an indication of the severity of the ventilator defect. HMV (NIV) is indicated to improve and stabilize gas exchange in COPD patients with chronic respiratory failure. This is a very different clinical strategy compared to prescribing supplementary oxygen which only improves blood oxygen saturation levels but does not improve gas exchange by lowering blood carbon dioxide levels and stabilizing blood pH.

Ventilator support for 10 h per day or greater (ie, daytime use)

The figure of “10 h” per day is a somewhat arbitrary figure that is not clinically supported. The 10 hour metric should not restrict patients who demonstrate less usage from receiving HMV(NIV) should their physician determine it as necessary therapy to address the condition.

Additional Comments/Recommendations:

Clinical Services Reimbursement

I support separate coverage and payment for clinical services in the home for this patient population. At present, however, there is no separate Medicare coverage and payment available to a DME provider for clinical services provided to patients in the home. CMS should consider updating policy to include payment for services associated with the complex and comprehensive management of patients in the home.

Timely Access to Therapy

The criteria should not be so burdensome as to create a barrier that effectively prevents the use of a ventilator and a clinician’s ability to order the ventilation therapy. Burdensome criteria will likely increase patient length of stay, disrupting the discharge process.

Diagnostic Criteria

Clinical and/or acceptance criteria should not be limited to available objective testing such as ABG. Recommend using other measures as well, such as:

VBG, ETCO2, or TcCO2

PFT (with other qualifying indicators – ex. chart notes documenting of Chronic Resp Failure and PFT)

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UnitedHealthcare (UHC) is responding to the National Coverage Analysis request for comments regarding the Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure Consequent to Chronic Obstructive Pulmonary Disease (COPD).

Current device-based payments create financial incentives to promote the use of one device over another, even if they have the same clinical benefit. Especially with pulmonary devices that are used for an extended period of time, a more expensive device can lead to a significantly higher cost to the Medicare program and for members over the life of the device.

UHC recommends basing device reimbursement on the treatment settings instead of the type of device. This will save money for the Medicare program and for members through lower coinsurance, with no difference in clinical outcomes.

In order to remain in compliance with federal requirements, the only viable means of utilizing a Home Mechanical Ventilator (HMV) to deliver continuous or intermittent positive pressure settings is to reimburse based on how the noninvasive ventilation (NIV) devices are used. As such, the positive pressure settings can remain in a capped rental fee structure and the vent settings in the Frequently and Substantially Serviced structure. We recommend extending the reimbursement for the Positive Airway Pressure (PAP) and Respiratory Assist Devices (RAD) to include the backward compatible HMV’s and have it be agnostic to the device. The vendor may deliver a RAD or an HMV set to the appropriate RAD setting.

There is a precedent in Medicare where the same make and model device is able to provide more than one treatment. In the area of Pneumatic Compression, for example, the same device, based on use, is coded as follows: “Use E0652 for Lymphedema. Use E0675 for Arterial Insufficiency. Use E0676 for DVT. Use E0217 for Cold Therapy. Use E0218 for Hot Therapy.

Some stakeholders may argue that Respiratory Assist Devices (Bi-Level PAP) should not be used to deliver Bi-Level therapy because they do not have sufficient alarms and back-up batteries. Understanding most current model E0471 devices have a comprehensive suite of monitors and alarms, alarms and back-up services are considered under the Social Security Act (SSA) as precautionary and not a benefit. CMS only moves services to the Frequently and Substantially Serviced (FSS) category if a service has a need for contingency plans and back-up features that are necessary to avoid risk to the patient health, and it has not been the case for Bi-Level RAD since 2006 or delivering the equivalent of RAD therapy through an HMV in present day. This was specifically addressed in the transmittal, “Pub. 100.4, Transmittal: 825, Feb 1, 2006, Change Request 4223,” and they were subsequently paid in the DME payment category for capped rental items.

UHC appreciates your consideration of basing device reimbursement on the treatment settings instead of the type of device. Additionally, we would like to express support for the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel’s recommendations.

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VGM Group

Comments - CMS Opening of NCA-Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for Treatment of Chronic Respiratory Failure consequent to Chronic Obstructive Pulmonary Disease (COPD) (CAG-00465N)

Introduction

VGM Group, Inc. (“VGM”) was founded in 1986 and is the nation’s largest and most comprehensive Member Service Organization (MSO) for post-acute healthcare suppliers. VGM’s array of services include DME/HME, Respiratory, Sleep, Wound Care, Complex Rehab, Women’s Health, Home Modifications, and Orthotic and Prosthetics suppliers. Over 2,500 suppliers with nearly 7,000 NPI locations rely on VGM to connect them to a valuable array of resources every single day. The HME industry plays an integral role in the lives of millions of Americans. We are commenting on behalf of our thousands of home medical equipment suppliers that continue to serve the sick and injured high risk population within their homes.

The home medical equipment suppliers have been on the front lines within the beneficiaries’ home providing access to the respiratory equipment prescribed in order to keep the beneficiaries at home while relieving stress on the inpatient hospital capacity.
The reconsideration proposes changes to two different NCDs (RAD and HMV). Before CMS makes any changes to the current ventilator (HMV) NCD, especially any restrictions which would compromise beneficiaries’ access to the most clinically appropriate device (such as the initiation of NIPPV with a home mechanical ventilator (HMV)), CMS should allow the time necessary to carefully assess the impact. While an important step, the current 30-day comment period is simply not enough time for a complete review, particularly in light of the current review of the RAD LCDs that interact with the NCD.

We urge CMS to pause the reconsideration related to the HMV NCD to allow time for technical assessment with more clinical data. In addition, the industry needs to understand the potential changes to the RAD NCD and LCD before any recommendations and comments can be made to a separate NCD for HMV.

During our review of the RAD reconsideration, we agree with the following recommendations:
1. When there is a diagnosis of COPD, eliminate the overnight oximetry-saturation requirement.
2. Hypoventilation should not be referred to in the CSA category.
3. To allow CPAP as therapy for CSA when it is shown to be effective.
4. To remove any requirements that a beneficiary must first try a BIPAP with a backup rate.
5. To remove the requirement of a sleep study to rule out OSA when there is a diagnosis of COPD.

VGM wants to thank you for providing us with the opportunity to submit comments. Some of our members are clinicians, but most are home medical equipment suppliers who engage daily with patients and their families to support the treatment modalities selected by their physicians and practitioners. We are the ones working the physicians and patients to provide access to the therapy necessary to treat the patients in their home 24/7.

Most importantly, CMS should prioritize patient access over cost concerns in relation to the initiation of NIPPV therapy with an HMV device to avoid the serious morbidity, additional hospitalizations, and increased mortality associated with patients failing to respond to treatment.

CMS should avoid adopting new policies in isolation of the RAD LCDs reconsideration.

We welcome the opportunity to participate in the ongoing dialogue to ensure that beneficiaries receive the right treatment, at the right location, and at the right time.

Sincerely,
Ronda Buhrmester
on behalf of The VGM Group
ronda.buhrmester@vgm.com

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The American Association for Homecare (AAHomecare) appreciates the opportunity to provide CMS with comments on CMS’ opening of the above captioned National Coverage Analysis (“NCA”). AAHomecare is the national association representing durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers, manufacturers, and other stakeholders in the homecare community. Our members are proud to be part of the continuum of care that assures Medicare beneficiaries receive cost effective, safe and reliable home care products and services. AAHomecare members serve approximately 80% of the Medicare beneficiaries with home care respiratory needs.

1. Summary of Comments

AAHomecare strongly urges CMS to establish clear and objective medical need criteria for coverage of NIPPV in the home for the treatment of chronic respiratory failure consequent to COPD. When medical professionals prescribe this therapy for their patients, it is important that the clinician community can provide objective medical record documentation that DME suppliers can rely upon to substantiate the individual’s medical need for the therapy. Without coverage criteria clarity, prescribers will not be able to know whether Medicare will support coverage for the individual’s particular medical need, and DME suppliers will be financially liable in the event of later audits.

For our detailed comments, AAHomecare convened a workgroup of its members, including clinicians, to comment on the Technical Expert Panel’s (“TEP’s”) September 9, 2021, “TEP Formal Request for CMS to reconsider the national coverage analysis for ventilators,” which we will refer to as the “TEP Formal Request.” Our comments on the “TEP Formal Request” recommendations, as they pertain to the treatment of chronic respiratory failure consequent to COPD, follow.

2. AAHomecare Comments on September 9, 2021, CHEST, AASM, AARC and ATS TEP Formal Request for Reconsideration of 280.1, Durable Medical Equipment Reference List: Ventilators, Pub. 100-03, Part 4, Chapter 1

A. Clinical Considerations

AAHomecare agrees with the TEP Formal Request’s proposed policy change, as they apply to coverage criteria for home mechanical ventilation:

1. Removal of pulse oximetry studies from any qualification criteria for home mechanical ventilation.
2. The prescribing clinician should determine the timing of when to start a particular respiratory therapy device.
3. Removal of any requirement that a beneficiary first tries a BPAP without a backup rate.
4. When there is a diagnosis of COPD, removal of a sleep study requirement to rule out obstructive sleep apnea (OSA).
5. The need for separate coverage and payment for respiratory therapist (RT) services in the home.
6. Inclusion criteria for use of HMV (NIV) for coverage the need of alarms, batteries, service, mouthpiece ventilation, and/or multiple pre-set prescription therapy modes.

B. AAHomecare’s Concerns with TEP Formal Request for Reconsideration

The following comments are AAHomecare’s response to the September 9, 2021, CHEST, AASM, AARC and ATS TEP Formal Request for Reconsideration of 280.1, Durable Medical Equipment Reference List: Ventilators, Pub. 100-03, Part 4, Chapter 1.

1. Medicare, clinicians and the industry are employing different terminology to describe the same technology. “Home mechanical ventilation, “non-invasive ventilation, “non-invasive positive pressure ventilation,” and other terms appear to be used interchangeably and inconsistently. The “TEP Formal Request” also appears to use the term non-invasive ventilator (NIV) to mean a BPAP (BILEVEL or BiPAP) with a backup rate, inconsistently with industry practice. AAHomecare therefore recommends that CMS establish specific terms for specific respiratory technology and define these terms to ensure consistency and uniformity. The HCPCS codes already contain defined terms for the different respiratory therapy devices. For example, non-invasive ventilators are described/defined by HCPCS code E0466 as “Home ventilator, any type, used with non-invasive interface (e.g., mask, chest shell).” AAHomecare recommends that CMS adopt terminology consistent with what exists in current HCPCS codes. Terminology clarification is also required for RAD/BPAP/Bi-level devices described by HCPCS codes E0470 and E0471.

2. There should be adequate access to HMV (NIV) for the treatment of patients with concurrent medical conditions.

Patients with “Overlap Syndrome”
“Overlap Syndrome” is when an individual with COPD also has sleep disordered breathing issues. From a coverage perspective, home mechanical ventilation should not be ruled out for these COPD patients; instead, the totality of the patient’s condition must be considered for potential coverage for HMV (NIV). AAHomecare is concerned that patients with suspected/confirmed OSA and COPD (overlap syndrome) may have their claims denied for HMV (NIV), even though the patient was undergoing COPD treatment. Chronic respiratory failure comorbidity with OSA is a complex and challenging condition that requires the proper respiratory device. The prescribing clinician should make the decision when to use the proper device HMV (NIV) or bilevel to treat COPD with chronic respiratory failure.

Patients with CRF and COPD
AAHomecare recommends that the PaCO2>45mmHg be used to determine hypercapnia. For consideration of alternative post-acute friendly methods of determining CO2 levels; EtCO2, TcCO2, or VBG. Even in the acute space, many facilities are defaulting to VBG instead of ABG as a primary metric for patient assessment. Any follow-up requirements to assess treatment response should take into account access to care challenges and allow for less invasive, widely accepted methods of monitoring outcomes EtCO2, TcCO2, and the prescribing physician’s evaluation.

3. The TEP Formal Request recommendation does not define “severe COPD.” Therefore, for documentation clarity and in the event of audits, there should be a clear definition. AAHomecare recommends, instead of using only arterial blood gas tests, qualification tests can be performed using VBG or noninvasive diagnostic devices for criteria such as EtCO2, TcCO2, and PFT, or using the most recent GOLD standard for severity of COPD including exacerbations of symptoms and hospital readmissions or emergency room and clinic visits. AAHomecare recommends that COPD severity should follow the GOLD severity classification scale of 1-4, patient medical history, exacerbations of symptoms, emergency room and clinic visits, and pulmonary function testing (PFT).

4. The TEP Formal Request recommends that coverage for HMV (NIV) occur when the patient requires higher pressures than those deliverable by E0471 (BiPAP) devices.

Equating pressure of the therapy with the severity of disease is not appropriate (high pressure doesn’t necessarily equate to severity of COPD).

It may not be the pressure that limits the efficacy of the device but the modes and advanced settings that assist with synchrony of the device with the patient, and the need for multiple pre-set therapy modes.

5. Regarding the TEP Formal Request recommendation that HMV (NIV) be covered for patients with an FiO2 higher than 40% or 5 L/min nasally. This is because this is greater than what can be supplied by an E0471 device in the home with the currently available technology.

E0471 is not an appropriate device if the patient has a need for oxygen over 4LPM, and, therefore, HMV (NIV) must be used as the appropriate device in this case of using oxygen.

COPD is a ventilatory issue, not only an oxygenation issue. As such, consideration for initiation of HMV (NIV) treatment for COPD should not consider oxygen liter flow. While oxygen dependency often goes hand in hand with COPD treatment, it is not an indication of the severity of the respiration or gas exchange defect. HMV (NIV) is indicated to improve and stabilize gas exchange in COPD patients with chronic respiratory failure. This is a very different clinical strategy compared to prescribing supplementary oxygen which only improves blood oxygen saturation levels but does not improve gas exchange by lowering blood carbon dioxide levels and stabilizing blood pH.

6. Regarding the TEP Formal Request’s recommendation that the patient demonstrate compliance, adherence to therapy (> 4 h per day), and there be a clinician evaluation 31 to 90 days after initiation of therapy, we note that:

The usage requirement of a minimum of 4 hours per day is an arbitrary value that has not been proven with data to be clinically beneficial for the COPD/CRF patient. The prescriber should be responsible for determining whether the patient is using and benefiting from the therapy by clinical follow up. The prescriber should be responsible for determining whether the patient is using and benefiting from the therapy. There are no known usage parameters that correlate with positive outcomes for this population.

7. Regarding the TEP Formal Request’s recommendation that coverage for a HMV (NIV) occur when the patient has a need of the therapy for 10 hours per day or greater (i.e., daytime use):

This is a poor qualifier for HMV (NIV) because we are not aware of any clinical evidence that points to 10 hours or greater as having a significant clinical impact. Any time a patient is using ventilatory support this should improve clinical outcomes.

AAHomecare supports the consideration of patient usage during activities of daily living (ADLs) and ambulation. BPAP units do not have battery capabilities and are therefore not portable, so a patient who requires ventilatory support whilst engaging in normal activities of daily living including physician visits must have a ventilator to maintain their mobility and activities of daily living. BPAP or RAD devices have limited capabilities as compared to HMV (NIV) devices. These limitations include, but are not limited to, mode limitations, pressure limitations, volume limitations, the inability to set multiple preset prescriptions for both day and night respiratory support, and alarms.

AAHomecare supports multiple pre-set prescription therapy modes. Multiple pre-set prescription therapy modes enable the physician to prescribe multiple modes of ventilatory support strategies to support the changing therapy needs of the patient. BPAP units are able to offer one mode or configuration of settings at a time. HMV (NIV) units have multiple modes of therapy to meet patients’ changing needs, the presets allow caregivers/patients to change the modes of therapies easily in the home setting.

B. Additional Key Considerations

1. The criteria should not be so burdensome as to create a barrier that effectively prevents the use of a ventilator and a clinician’s ability to order the ventilation therapy. Burdensome criteria will likely increase patient length of stay, disrupting the discharge process.

2. Clinical and/or acceptance criteria should not be limited to available objective testing such as ABG for both BiPAP and HMV qualification. AAHomecare recommends using other measures as well, such as:

VBG, ETCO2, or TcCO2

PFT

chart notes documenting chronic resp failure

GOLD classification for COPD

3. Potential Access Issues:

In developing a new NCD, it is important to understand the potential access issues that may result from the creation of new and potentially burdensome requirements for clinicians. Not all COPD patients have ready access to a pulmonologist on their care team or a doctor that is familiar with all the criteria for BPAP (NIPPV) or HMV (NIV). In addition, there may be a lack of access to a clinic to perform certain testing (e.g., ABGs). It is also important to note that many tests (such as PFT, EtCO2, and TcO2) can be performed in the patient’s home, which will require appropriate coverage and payment for the RT services.

If a coverage policy requires additional clinician and clinic visits (e.g., multiple follow-up visits), patients often have difficulty scheduling timely visits due to demand and transportation issues. These access issues are particularly pronounced in rural areas with fewer clinicians and clinic locations, and where travel time and distance from the patient’s home to the clinic are significant.

Telehealth can be a solution to facilitate clinician/patient communications and assessments but access issues are prevalent due to limited coverage and payment for these services. Some physician groups do not have access to telehealth. Large hospital organizations’ firewalls do not allow for easy access to the monitoring platforms, leaving the physician to contact the DME supplier to provide copies of the data. In rural areas, there is limited telehealth access to cloud-based monitoring. Also, the price of data platforms can be very expensive.

C. Operational Considerations

AAHomecare has some significant concerns with the recommended guidelines. Excessive, vague and subjective documentation requirements will only place the DME supplier at financial risk. For example, the TEP Formal Requests recommends a requirement for a “clinician evaluation for day 31-90 after initiation.” It is unclear what kind of clinician can complete the evaluation. The responsibility for evaluating the patient should fall on the treating practitioner, in collaboration with the patient to demonstrate use and clinical benefit. These parameters should be clearly and objectively defined to facilitate consistent and measurable outcomes.

D. Reimbursement Considerations

1. AAHomecare supports separate coverage and payment for RT services in the home for these patients. At present, however, there is no separate Medicare coverage and payment for RT services provided to patients in the home. It would be financially untenable to require DME suppliers to pay for these services without any corresponding reimbursement.

2. AAHomecare is concerned about increased documentation and other obligations that will increase suppliers’ costs. Increasing suppliers’ costs of doing business through increased monitoring and clinician services without increasing reimbursement will make it challenging for suppliers. If CMS considers increasing the number of follow up visits, as suggested by the TEP Formal Request, clinician visit reimbursement should be an important topic to address in order to accomplish any of the suggested follow up visits.

3. Support of Other Comments

AAHomecare specifically supports the comments that others are submitting to CMS that, in summary, recommend that a revised, updated NCD for NIPPV use to treat COPD-CRF should:

1. Indicate HMV (NIV) coverage for hypercapnic COPD-CRF patients who have an elevation of PaCO2 above the upper limit of normal.
2. State that HMV (NIV) should be initiated as soon as possible following the diagnosis of hypercapnic COPD-CRF.
3. State that the choice of device is at the discretion of the prescribing healthcare provider, and not require patients to try and fail BPAP/RAD therapy before coverage is provided for an HMV (NIV).
4. Not require an arbitrary “hours of use” metric for continued NIV(HMV) coverage. While adherence to HMV (NIV) is important to optimize outcomes, the minimal usage necessary to achieve this is unknown. Any use is enough use for the patient to keep the equipment.
5. Not require patients to requalify for HMV (NIV). Hypercapnic COPD-CRF is a persistent disease with no known cure, so requalification is an unnecessary burden and wastes health care resources.
6. Not require overnight oximetry or sleep tests to qualify hypercapnic COPD-CRF patients for HMV (NIV).
7. Not implement requirements that stand to worsen health equity among Medicare beneficiaries. Hypercapnic COPD-CRF is more common in African Americans and in economically disadvantaged people. Any NCD changes that limit access to HMV (NIV) will disproportionately affect these groups.

4. Additional Comments

a. Clinical Decisions Should Not Be Driven by Cost Considerations

The most cost-effective patient care will ensue when each patient receives the most medically appropriate medical device for that patient’s particular clinical needs in their home. We urge CMS to focus on the most clinically appropriate respiratory therapy, rather than on the costs of any therapy in any revision to the Medicare national coverage policy for HMVs (NIVs).

b. Need for Clear and Objective Criteria

In order to ensure beneficiary access to the most appropriate respiratory therapy, coverage criteria for HMV (NIV) must be based on objective and clear clinical criteria. Therefore, there should be specific testing criteria for beneficiaries to qualify for HMV (NIV) therapy that are separate from criteria for other respiratory devices.

Access to NIV therapy should be available to those whose testing meets the criteria, and the prescriber has identified that HMV (NIV) is their therapy of choice.

Historical experience demonstrates that insufficient documentation is typically the number one reason for high improper payment rates for DME, not medical need. CMS’ 2023 CERT report identified that only 1.8% of the ventilator error rate was due to medical necessity, with an overall error rate of 24.3% of which insufficient documentation made up the majority.

5. Conclusion

We appreciate the opportunity to provide these comments. Please feel free to reach out with any questions, or if you would like additional information at tomr@aahomecare.org.

Sincerely,

Tom Ryan
President and CEO
American Association for Homecare

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CMS,
We are the largest locally owned and operated DME provider in the PNW. We work very closely with our medical community on a daily basis to provide both NIV and RAD devices. We are asking that you hold off on making changes to the current NCD policy for coverage of NIPPV until the DME MACs complete their review of the LCDs for respiratory assist devices.
The current RAD policy is very challenging for patients to meet criteria and has many barriers to patient access of these devices. Delays in patient home care are all too common and frustrating with the RAD policy. The grey area between RAD and NIPPV policy is unfortunate and a hardship for all involved parties (patient, doctor, DME, Medicare). The policies should work together and not compound the confusion. Having the LCDs finalized before the NCDs for ventilators are modified is critical to achieve this goal. We need to get this right. By creating policy out of this sequence, it is likely that more barriers will arise for patients to gain access to timely homecare.
Patient access to NIV, especially for the COPD population given the prevalence in our county, is absolutely vital to healthcare as a whole. These devices keep people out of the hospital, reducing costs and let them live their lives in their homes. We have seen numerous insurers lately delay or deny care for ventilators due to arbitrary clinical guidelines they are self-imposing, such as "tried and failed techniques" or ridiculous usage requirements that stem from CPAP guidelines. COPD patients and neuromuscular patients are much different than sleep patients and often need access much quicker. Having them try another device that everyone within the care community knows is not going to treat their ailment is a simple barrier we can remove. We are imploring you to use common sense in these decisions. This is a great opportunity to improve access, clarify guidelines and get everyone on the same page for how to provide the right device at the right time.

Thank you.

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October 11, 2024

Tamara Syrek Jensen Director, Coverage and Analysis Group Centers for Clinical Standards and Quality Centers for Medicare & Medicaid Services 7500 Security Blvd. Baltimore, MD 21244

Re: NCD 280.1 - National Coverage Analysis for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure Consequent to Chronic Obstructive Pulmonary Disease (COPD)

Philips is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Philips’ diagnostic and therapeutic solutions – sleep and respiratory care, diagnostic imaging, image-guided therapy, and cardiac monitoring – are utilized in the care of Medicare beneficiaries.

Philips appreciates CMS’ reconsideration of National Coverage Decision (NCD) 280.1, to establish coverage policies for the use of noninvasive home mechanical ventilators (NIPPV) and respiratory assist devices for Medicare beneficiaries with Chronic Obstructive Pulmonary Disease (COPD). We are pleased CMS accepted the NCD reconsideration request from the clinical experts - The American College of Chest Physicians (CHEST), the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

An NCD based on clinical expert experience and peer-reviewed clinical evidence to justify the selection of devices used in the treatment of Medicare beneficiaries with COPD will help identify the appropriate care for each patient and allow for a more evidence-based approach. This growing body of evidence supports the improved care and outcomes for patients who will benefit from these devices, necessitating an update to the coverage policies to reflect current clinical practice and technology innovations.

We recognize CMS’ history of engaging with providers to improve coverage policies for NIPPV. Since 2014, the pulmonology community has collaborated with CMS’ Coverage and Analysis Group (CAG), MEDCAC, and AHRQ to address gaps in access to this critical therapy for various patient populations, including those with COPD. In the last four years, there have been several activities and recommendations made by respected government agencies that provide valuable support for revision of the NCD.

In response, the relevant medical societies convened their own Technical Expert Panel (TEP) to thoroughly evaluate these clinical coverage policies. The TEP recognized that advancements in home mechanical ventilation, bilevel positive airway pressure (BPAP) devices, and continues positive airway pressure (CPAP) devices, along with evolving clinical evidence, have expanded the applicability of these technologies across a broader range of clinical scenarios.

The TEP brought together clinical experts from the pulmonary, sleep, and respiratory care fields to provide guidance on the appropriate use of NIPPV devices for chronic obstructive pulmonary disease (COPD), neuromuscular diseases, and obesity hypoventilation syndrome. Specifically, the Optimal NIV Medicare Access Promotion (ONMAP) guidelines focus on improving access to NIPPV for Medicare patients, particularly those with chronic respiratory conditions like COPD. The ONMAP findings in COPD revealed that NIPPV can play a significant role in managing patients with COPD. This peer-reviewed evidence supports the improved care and outcomes for patients who benefit from these devices, necessitating an update to the coverage policies to reflect current clinical practice and technology innovations.

A clear and comprehensive NCD will establish well-defined criteria for clinical use and ensure that patients who meet specific medical guidelines receive the therapy. Clear clinical guidelines within an NCD provide crucial direction for both practitioners and Durable Medical Equipment (DME) providers, helping them avoid unintentional misuse of NIPPV and related devices. By outlining the proper indications, clinical requirements, and usage scenarios, the NCD will help healthcare providers deliver the most appropriate care to the patients they serve.

Patients from underserved populations, including racial and ethnic minorities, low-income groups, and those in rural areas, often face barriers to accessing advanced respiratory care. Expanding coverage for NIPPV ensures that patients with chronic respiratory conditions like COPD, neuromuscular diseases, or obesity hypoventilation syndrome can receive appropriate treatment. NIPPV can be used to manage chronic respiratory failure at home, reducing the need for emergency hospital visits and readmissions. By enabling patients to receive care in the home setting, it can help address disparities in healthcare access, particularly for those in remote areas with limited access to specialized care facilities.

Philips encourages CMS consider the peer-reviewed literature and the recommendations of the clinical experts - CHEST, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society recommendations and align Medicare coverage with the ONMAP guidelines in COPD. Thank you for the opportunity to provide input into NCD 280.1 - National Coverage Analysis for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure Consequent to Chronic Obstructive Pulmonary Disease (COPD).

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Apria is a leading provider of home healthcare equipment and related services. We have 275 locations nationwide and serve more than 2 million patients, including large populations of traditional Medicare beneficiaries and Medicare Advantage members. Our valuable services enable patients to avoid hospitalization, live more mobile and independent lives, and improve their quality of life at home.

We appreciate the opportunity to provide feedback regarding the request by the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel (TEP) for CMS’ reconsideration of coverage policies relative to the use of non-invasive positive pressure ventilation (NIPPV) in the home for the treatment of CRF consequent to COPD.

Apria has carefully reviewed the TEP request and agrees with many of its positions, however we strongly urge CMS to consider our additional recommendations below. By providing clear and objective medical criteria that updates the RAD LCD in conjunction with the NIPPV NCD, we believe many of the COPD care access issues will be addressed and the appropriate care can be provided with the right device, to the right patient, at the right time, as determined and prescribed by the patient’s physician.

Apria agrees with the TEP’s recommendation to remove any requirement for use of a BPAP without a backup rate. By removing this requirement, COPD patients would have immediate access to appropriate devices equipped with a backup rate that is intended to support patients with ventilation insufficiency or failure issues. As indicated in the manufacturers’ user manuals, BPAP without rate devices are intended to treat Obstructive Sleep Apnea (OSA). Therapy settings should be determined by the prescribing physician, whereas the device determination (E0471 vs E0466) would be dependent on the pressure requirements, therapy mode or setting requirements, and home safety considerations. The TEP also recognizes the BPAP device limitations and includes indications for home mechanical ventilation (HMV) in their recommendations for the most appropriate device. Apria has provided additional suggestions for the home mechanical ventilation (HMV) recommendations from the TEP.

We also agree with many other recommendations proposed by the TEP, such as having the physician determine when to initiate BPAP or home mechanical ventilation (HMV), the use of clinical criteria to determine need, the removal of the nocturnal pulse oximetry requirement for all ventilation access qualification requirements, sleep studies not being required to rule out OSA for the diagnosis of COPD for home mechanical ventilation and the important role of respiratory therapists. We also have several suggestions to enhance the panel’s recommendations to ensure that the clinical needs of this vulnerable patient population are met.

Clinical Coverage Criteria
We support the use of objective clinical qualification criteria for HMV therapy, as it will eliminate confusion among physicians, auditors, and suppliers, and ensure beneficiary access to the appropriate respiratory therapy for their medical needs.

We believe that arterial blood gases (ABG) should not be the only indicator when a patient is being evaluated for hypercapnia with COPD and recommend evaluating all testing that may expose ventilation failure or insufficiency, such as venous blood gas (PvCO2) and end-tidal CO2 (ETCO2 tests). Additionally, we recommend lowering the qualifying ABG to a PACO2 > 45 mmHg. We also strongly recommend that patients with overlapping conditions of COPD and OSA be allowed to follow the COPD pathway without restriction. A patient’s COPD treatment needs should not be ignored just because he/she also has an OSA diagnosis. The right device will treat both conditions and this needs to be determined by the physician in the prescribed therapy.

We strongly disagree with the TEP recommendation for clinical evaluation of the BPAP 31-90 days after initiation. Physicians should be allowed to determine if the patient is benefitting from the therapy at any time and should not need to wait before transitioning the patient to the appropriate device for their condition. Additionally, we do not agree with an hourly adherence threshold requirement. Patients who are on ventilation devices have synchrony issues that need ongoing monitoring and adjustments because COPD is a progressive disease with constantly changing lung conditions. See citations (1) and (2) below. Patients may not be able to achieve adherence >4 hrs./day if they need setting adjustments or are failing on this device and need to transition to HMV. Hourly adherence should not be used as a threshold to determine continued coverage. Any use of the device should be sufficient for a physician to determine if the device is appropriate for the patient or needs to be adjusted accordingly.

We propose the following revisions to the TEP process flow for COPD patients:
For Severe COPD, we recommend a combined pathway that addresses both BPAP & HMV access:

If criteria 1 and 2 below apply, patient would qualify for BPAP with rate.

If criteria 1, 2 and 3 below apply, patient would qualify for HMV.
If ventilation goals are not met with the BPAP with rate, at any time, patients may transition to HMV as prescribed.
1. Testing while awake breathing usual FiO2 demonstrates hypercapnia with any of the following:

PaCO2 >45 mmHg

PvCO2 >51 mmHg

ETCO2 >45 mmHg

TcCO2 >45 mmHg
2. Obstructive Sleep Apnea has been considered and excluded (formal sleep testing not required). Note: This OSA exclusion requirement does not apply to patients with overlapping syndrome of OSA and COPD; these patients should also follow the COPD pathway as outlined without restriction when the patient also has an OSA diagnosis.
3. Patient requires any of the following:

Daytime use

Inspiratory pressure higher than those deliverable by E0471

Need for FiO2>0.40 or >4 L/min bled in while in a VAPS mode

Need for mouthpiece ventilation during the day or any other multi-preset settings

Need for battery backup/advanced alarm requirement

Physician order for auto adjusting EPAP settings

The patient’s weight is less than the intended weight for use as dictated by the BPAP manufacturer’s manual

Reimbursement for Clinical Services
We concur with the TEP that respiratory therapists (RT) are a critical element of care for ventilated Medicare beneficiaries in the home. However, although the TEP proposal emphasizes the importance of these services and recommends increased monitoring, they do not provide a clear pathway for clinical reimbursement. The DME Quality Standards require respiratory therapists to evaluate therapy efficacy, perform assessments, and be available for home visits and pressure setting adjustments, although there is no coding or policy for reimbursement for billing home RT services. Requiring suppliers to expand clinician services and monitoring without providing reimbursement is fiscally challenging for suppliers, especially in these inflationary times when suppliers are faced with rising costs in other areas such as product acquisition, staffing, delivery, and operations.

Therefore, we urge CMS to allow payment to DME suppliers for respiratory therapy services (in-person and via telehealth) with services time (for each visit) that is comparable with CPT 99349 (2.33 wRVU value; Home Visit Services Moderate level MDM or at least 40 minutes total time). Consistent follow up by a clinician for patients needing ventilation support and intervention is critical to improved care and outcomes, and DME suppliers should be reimbursed for providing these important and costly services.

COPD Patient Monitoring
We disagree with the TEP’s proposal to include all of the following elements in NIV patient follow up:
1. Targeted clinical assessment by experienced personnel familiar with the diagnosis and consequences of COPD and use of NIV
2. ABG PaCO2 to determine response to therapy and help adjust the ventilator to the evolving needs of the patient
3. Nocturnal pulse oximetry as a dynamic complement (for monitoring only, not initiation) to ABG
4. Trend report from ventilator software that is now available in most modern devices; these provide information on patterns of use, synchrony and triggered breaths, respiratory rate, tidal volume, and minute volume and leaks

We recommend the removal of the ABG testing requirement and think it is inappropriate to require this for patients to remain on therapy. The patient’s physician should be able to determine if he/she is benefitting from therapy without this invasive testing. Patients who develop Hypercapnic Respiratory Failure with COPD who have started on HMV will rarely improve to a point where they no longer need ventilation support. Requiring patients to repeatedly justify their need for this therapy with PACO2 testing is extremely invasive and burdensome to a vulnerable patient population with a degenerative disease state. Furthermore, many of these patients already have access to care issues and this requirement could be very difficult for them to accomplish. This additional testing requirement is a waste of health resources and the Medicare Trust Fund.

We are also concerned about the requirement to obtain trend reporting from ventilator software. Suppliers have the option of obtaining these reports via manual download or electronically via external ventilator modems, which have monthly non-reimbursable supplier service fees, and may be challenging to obtain due to potential patient wi-fi access issues. We therefore recommend that this requirement be changed to: Trend report from ventilator software, if available.

Additionally, as stated above, we urge CMS to allow payment to DME suppliers for any monitoring activities requiring respiratory therapists.

Adherence
The TEP indicated, “The single most important factor associated with a poor outcome was low adherence (NIV use <4 h/day). For this reason, we recommend adaptation of adherence criteria as proposed in the other TEP reports, including the second 90-day trial period for those patients not meeting initial adherence criteria for continued coverage who return at least twice to a treating physician and see benefit from continued use.”

Studies have shown that poor adherence is tied to health literacy and is worse in lower socioeconomic groups. We believe this policy would accentuate existing healthcare disparities. See citations (3) and (4) below.

We disagree with a minimum usage requirement and any trial periods. Any usage by a patient on NIV therapy should allow ongoing coverage to continue while the clinician modifies synchrony and pressure settings to meet the patient’s ventilation demands. Withholding reimbursement from DME suppliers while clinicians are working with patients puts administrative and financial burdens on the supplier and is not an approach that would facilitate positive clinical outcomes for the patient. Clinical involvement with patients who show effort but do not meet a minimum standard of usage are the patients who should be actively supported to make the necessary therapy and setting changes that will properly address patient tolerance with the device.

Thank you for your consideration of our comments and recommendations. Please feel free to contact me at pbernocchi@byramhealthcare.com if you have any questions.

Sincerely,
Perry Bernocchi, Chief Executive Officer

__________________________________________________________________________________________________________

Citations
(1) DR., Hess. "Patient-ventilator interaction during noninvasive ventilation." Respir Care. (2011 Feb;): 56(2):153-65; discussion 165-7. doi: 10.4187/respcare.01049. PMID: 21333176. doi: 10.4187/respcare.01049. PMID: 21333176.

(2) Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. "Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation:." A Randomized Clinical Trial. JAMA. . (2017 Jun 6): 317(21):2177-2186. doi: 10.1001/jama.2017.4451. PMID: 28528348; PMCID: PMC5710342.

(3) Pandey A, Mereddy S, Combs D, Shetty S, Patel SI, Mashaq S, Seixas A, Littlewood K, Jean-Luis G, Parthasarathy S. "Socioeconomic Inequities in Adherence to Positive Airway Pressure Therapy in Population-Level Analysis." J Clin Med. (2020 Feb 6): ;9(2):442. doi: 10.3390/jcm9020442. PMID: 32041146; PMCID: PMC7074027.

(4) May AM, Patel SR, Yamauchi M, Verma TK, Weaver TE, Chai-Coetzer CL, Thornton JD, Ewart G, Showers T, Ayas NT, Parthasarathy S, Mehra R, Billings ME. "Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds:An Official American Thoracic Society Policy Statement." Am J Respir Crit Care Med. (2023 Feb 1): 207(3):244-254. . doi: 10.1164/rccm.202210-1846ST. PMID: 36722719; PMCID: PMC9896653.

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October 11, 2024

Kimberly Long
Lead Analyst
Center for Coverage and Analysis
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Susan Miller, M.D.
Lead Medical Officer
Center for Coverage and Analysis
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (Tracking Number: CAG-00465N).

Dear Ms. Long and Dr. Miller,

On behalf of the members of the Council for Quality Respiratory Care (CQRC), I want to thank you for providing us with the opportunity to submit comments on the National Coverage Analysis (NCA) entitled: “Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD” (Tracking Number: CAG-00465N). Consistent with the request, our comments will focus on NIPPV in the home for the treatment of Chronic Respiratory Failure (CRF) consequent to Chronic Obstructive Pulmonary Disease (COPD).

The CQRC is a coalition of the nation’s six leading home oxygen therapy provider and manufacturing companies: AdaptHealth, Apria, Lincare, Philips, ResMed, and Rotech Healthcare. Together, CQRC members provide in-home patient services and respiratory equipment including liquid oxygen, oxygen concentrators, and sleep therapy devices, to more than 600,000 of the more than one million Medicare beneficiaries who rely upon home oxygen therapy to maintain their independence and enhance their quality of life. The CQRC members also employ approximately 35,000 people in the United States.

In our effort to respond to the specific request for additional data, we reference peer-reviewed literature published after the studies referenced in the Agency for Healthcare Research and Quality (AHRQ) Technical Assessment entitled “Noninvasive Positive Pressure Ventilation in the Home” (Technical Assessment). The Technical Assessment relied on studies from 1998 to 2006 and included a recommendation for further studies. Several studies have been published since 2006, which suggests that it would be prudent for CMS to take additional time to update the assessment before initiating changes in the current National Coverage Determination (NCD) CMS is reviewing in this NCA. While the attached letter requesting reconsideration includes some additional information, there are other studies not referenced.

In addition, we understand that the Durable Medicare Equipment (DME) Medicare Administrative Contractors (MACs) have begun reviewing the related Local Coverage Determinations (LCDs) related to the use of Respiratory Assist Devices (RADs) for the treatment of CRF consequent to COPD as well. As discussed below, the inter-related nature of the LCDs and NCD argue for not opening the reconsideration of the current NCD until the LCDs have been updated.

Moreover, as noted in more detail in Section I, it is important that CMS recognize the inequities many Americans have faced when it comes to appropriate diagnosis and management of COPD and the follow-on condition of CRF consequent to COPD. Before making changes to the current NCD, especially any limitations that could create additional barriers restricting beneficiary access to the appropriate device (such as the initiation of NIPPV with a home mechanical ventilator (HMV) for specific patients), CMS should take the time necessary to carefully assess the potential impact of this policy change on minority populations, including people of color, who are more susceptible to respiratory diseases and suffer the burden of untreated conditions (1).

While an important step, the current 30-day comment period is simply not enough time for a complete review, particularly in light of the current review of the RAD LCDs that need to interact with the NCD to avoid patients “falling through the cracks.” Thus, the CQRC urges CMS to pause this NCD reconsideration request to allow for the review of the LCDs and additional time to update the technical assessment with more recent clinical data and additional consideration of how changes in the current policy could expand existing health inequities.

COPD, which prevents airflow to the lungs causing severe respiratory problems, is a leading cause of death in the United States (2). Those most at risk for COPD are individuals who often experience health inequities and experience lower socio-economic status. They generally have encountered significant barriers when it comes to accessing health care. These at-risk individuals include:

• Women;
• American Indian or Alaska Native populations and people of more than one race;
• People who are unemployed, unable to work, retired, a homemaker or a student; and
• People with less than a high school education (3).

Individuals with COPD who develop CRF consequent to COPD experience poor health outcomes and significant mortality; one study reported mortality among this population to be nearly 20 percent within three-years of diagnosis (4).

Given recent findings of racial bias in pulse oximetry measurement (5), it seems likely (although we acknowledge that more analysis is needed) that people of color (particularly Black Americans) are less likely to be diagnosed in the early stages of COPD which can lead to a delay in the onset of treatment. In turn, any delay in an initial diagnosis allows COPD to progress more rapidly to CRF. While there is no cure for CRF consequent to COPD, making sure that individuals once diagnosed receive the right treatment without experiencing further access barriers is essential to preventing the perpetuation of the inequities many of these patients have already experienced.

Without a curative option, physicians primarily prescribe positive airway therapies to reduce the risk of exacerbations, hospitalizations, and death in individuals with CRF consequent to COPD (6). Physicians treating these individuals can prescribe one of three types of devices to deliver different types of positive airway therapy: Continuous positive airway pressure (CPAP), Bi-level positive airway pressure (BPAP), or Home Mechanical Ventilators (HMV). The latter two devices (BPAP and HMV) deliver noninvasive positive pressure ventilation (NIPPV) to the patient in different ways.

As the AHRQ TA states BPAP equipment is “a machine 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). Sometimes these devices are referred to as RAD” (7). The currents LCDs for RAD set the coverage rules for BPAP devices. The literature review reported in the Technology Assessment noted that NIPPV when delivered by a BPAP device (when compared to a patient without a device) “was associated with lower mortality, intubations, and hospital admissions” (8). A 2022 study reported in The American Journal of Medicine found that the initiation of BPAP has been shown to reduce mortality (9).

The AHRQ TA states that HMV equipment is “a machine capable of delivering pressure targeted, volume targeted, and/or volume present ventilation outside of the hospital setting…Compared to BPAP machines, HMVs typically have additional monitoring, ventilator control, safety, and backup power features that may be appropriate for particular COPD patients that are not suited for treatment with BPAP machines. For example, HMVs are classified by the Food and Drug Administration (FDA) as ‘life support devices.’” (10). The NCD on which this comment is directed governs HMV equipment. The Technical Assessment noted that NIPPV delivered by an HMV was associated with fewer hospitalizations when compared to individuals with a BPAP, CPAP, or no device (11). The more recent 2022 retrospective analysis of administrative claims data of hospitalizations in patients with COPD (a study comparing the association between device use and hospitalization using different devices) supports the conclusion that treatment with an HMV results in significantly fewer hospitalizations than treatment with a BPAP device (12). The findings from this study may offer insights to the clinical community into what could possibly occur for patients in a home setting.

In our view physician judgement remains essential to determining when to prescribe a BPAP or HMV for home use. Several studies have begun to assess the presence of certain clinical characteristics that would argue against initiating therapy with a BPAP device in all patients in hospital (13); these studies may support the conclusion that patients with these characteristics should begin therapy with an HMV and not be forced to use a BPAP device first because of the likelihood the treatment will fail with resulting hospitalization. Additional studies are needed before a national policy modifying or limiting access to HMV in the home is considered.

Medicare plays a unique role in the treatment of COPD and CRF consequent to COPD because those most at risk for COPD are adults 65 and older (14). As a result, its coverage criteria will determine whether or not the vast majority of individuals with CRF consequent to COPD will have access to the medical device that will most likely reduce their risk of morbidity and mortality, as well as reduce their risk of hospitalization. If Medicare’s coverage criteria are too restrictive or require starting all patients on one device regardless of their physician’s best medical judgment on device choice, then these patients will be at risk for increase morbidity, hospitalization, and mortality. Given the significance of this decision and its impact on patient outcomes, we urge CMS to pause the reconsideration of this NCA to allow the DME MACs to complete their review of the LCDs governing RADs (including BPAPs) first to avoid unnecessary barriers to patients accessing the device that in the judgment of their physician will best treat that patient’s disease.

The current NCD relies upon a physician’s determination that an HMV is the right device for each patient diagnosed with CRF consequent to COPD. As the current NCD recognizes, CRF consequent to COPD includes “conditions that can vary from severe and life-threatening to less serious forms.” As a result, a physician may select a BPAP, which is governed by the RAD LCD or an HMV (also known as a non-invasive ventilatory (NIV)) governed by the current NCD. In 2017, CMS noted that the “[c]hoice of an appropriate treatment plan, including the determination to use a ventilator vs. bilevel PAP device, is made based upon the specifics of each individual beneficiary’s medical condition.” (15) Given the state of current clinical literature, it is imperative that CMS does not act so quickly that it creates unnecessary barriers to accessing HMV by putting in place additional coverage limitations that are not grounded in peer-reviewed literature.

Clinical, peer-reviewed literature supports the current approach that physicians use their best judgment based “each individual beneficiary’s medical condition” when selecting the appropriate device. Several clinical studies have demonstrated that patients with certain risk factors are more likely to experience BPAP “failure” (meaning the patient does not respond to the BPAP treatment) if NIPPV therapy is initiated with that device rather than an HMV. Most recently in 2022, Mosher et al. reaffirmed these findings and identified four additional clinical factors that physicians should consider when choosing between a BPAP and HMV in hospitalized patients. These include age (older patients are more likely to fail BPAP), BMI (patients with higher BMIs were at greater risk of treatment failure when started on BPAP), bicarbonate levels, and creatinine (which is associated with a greater risk of kidney disease as well) (16). While more work needs to be done in this area of research, these studies show that there are clinical differences that may make starting a patient on an HMV appropriate. CMS policy should continue to support physician judgment when it comes to determining which device to selection for the initiation of NIPPV given the current state of clinical literature.

For example, public policy in the form of reimbursement should not force a patient to use a BPAP if in the judgment of his/her physician it would be more appropriate for the patient to initiate therapy using an HMV. No patient should have to endure the negative physical and emotional impact of being placed on a device that may not help the patient achieve the desired outcomes as defined by their physician. For a patient, “failing” on a BPAP device means potentially experiencing COPD exacerbation. During an exacerbation, a patient cannot breathe because of increased airway and systemic inflammation and physiological changes, especially the development of hyperinflation (17). Often, patients must be hospitalized to address the clinical problems. If not treated in time, the patient may die. One study estimates that the average time it takes a patient to fail when placed on BPAP instead of HMV in a hospital is approximately eight hours. The same study, however, recognizes that it may take up to 48 hours for failure to be recognized (18). For a patient at home, experiencing a failure of this nature not only has significant negative health outcomes, but also creates a traumatic experience. If a physician anticipates a BPAP will not work for a particular patient, the patient should be treated with the device chosen by the physician, not reimbursement policy.

Because COPD exacerbations are a major cause of morbidity, mortality, and reduced health status, they also are a costly and substantial burden on the health-care system (19). A patient who “fails” with a BPAP must also pay additional co-insurance and other costs that result from being placed on the inappropriate device for their condition. If a physician believes based on the diseases status and other characteristics of an individual patient that initiating NIPPV therapy using an HMV is the best treatment strategy, federal policy should support that conclusion and not create additional barriers to accessing the HMV that could result in harmful patient outcomes.

We acknowledge that there are many outstanding questions when it comes to the clinical factors that indicate when NIPPV treatment should be initiated using an HMV device. The current NCD recognizes that fact and focuses on the diagnosis of CRF consequent to COPD rather than trying to establish other diagnoses or clinical characteristics that must also be present. As studies defining these factors continue to emerge, it may be appropriate to reopen the NCD.

Despite positioning from some clinicians, we do not believe the current data are sufficient to do that at this time. Based on the request to reopen the NCD, it appears that clinicians are concerned the current restrictions/limitations on ordering BPAP devices, and establishing a standard in the LCD process, is the key goal. As noted, we understand that the DME MACs are reviewing these LCDs. Given the inter-related nature of BPAP and HMV, we urge CMS to allow the DME MACs to complete their task, which includes providing an opportunity for public review and comment, before reopening the NCD for HMV. Finalizing an NCD policy prior to addressing the clinicians’ concerns with the LCDs could result in significant access barriers for individuals accessing either of these devices.

On behalf of the CQRC, I want to thank you for providing us with the opportunity to submit comments. While not clinicians, our members engage daily with patients and their families/care partners to support the treatment modalities selected by their physicians. We urge CMS to tread carefully to ensure that federal policy does not aggregate already serious health inequities many individuals with CRF consequent to COPD already face. The agency should also avoid adopting new policies in isolation of the RAD LCDs reconsideration. Most importantly, CMS should prioritize patient access over cost concerns in relation to the initiation of NIPPV therapy with an HMV device to avoid the serious morbidity, additional hospitalizations, and increase mortality associated with patients failing to respond to treatment. We welcome the opportunity to participate in the ongoing dialogue with you and your team to ensure that beneficiaries receive the right treatment, at the right location, and at the right time.

Sincerely,

Kathy Lester
Executive Director
Council for Quality Respiratory Care

1. The NHLBI Working Group. “Respiratory Diseases Disproportionately Affecting Minorities.” 108 CHEST, , 1380 - 1392 (Nov. 1995).
2. Centers for Disease Control & Prevention (CDC). “Chronic Obstructive Pulmonary Disease (COPD): About COPD.” CDC Website, May 15, 2024.
3. Id.
4. Carone, M., Antoniu, S., Baiardi, P., Digilio, V. S., Jones, P. W., & Bertolotti, G. (2015). Predictors of Mortality in Patients with COPD and Chronic Respiratory Failure: The Quality-of-Life Evaluation and Survival Study (QuESS): A Three-Year Study. COPD: Journal of Chronic Obstructive Pulmonary Disease, 13(2), 130–138. https://doi.org/10.3109/15412555.2015.1067294.
5. Sjoding, M.W.; Dickson, R.P.; Iwashyna, T.J.; Gay, S.E.; Valley, T.S. Racial bias in pulse oximetry measurement. N. Engl. J. Med. 2020, 383, 2477–2478.
6. Vasquez, M. M., McClure, L. A., Sherrill, D. L., Patel, S. R., Krishnan, J., Guerra, S., & Parthasarathy, S. (2017). Positive Airway Pressure Therapies and Hospitalization in Chronic Obstructive Pulmonary Disease. The American journal of medicine, 130(7), 809–818. https://doi.org/10.1016/j.amjmed.2016.11.045; Frazier, W. D., Murphy, R., & van Eijndhoven, E. (2021). Non-invasive ventilation at home improves survival and decreases healthcare utilization in medicare beneficiaries with Chronic Obstructive Pulmonary Disease with chronic respiratory failure. Respiratory medicine, 177, 106291. https://doi.org/10.1016/j.rmed.2020.106291; Köhnlein, T., Windisch, W., Köhler, D., Drabik, 7. A., Geiseler, J., Hartl, S., Karg, O., Laier-Groeneveld, G., Nava, S., Schönhofer, B., Schucher, B., Wegscheider, K., Criée, C. P., & Welte, T. (2014). Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. The Lancet. Respiratory medicine, 2(9), 698–705. https://doi.org/10.1016/S2213-2600(14)70153-5; Murphy, P. B., Rehal, S., Arbane, G., Bourke, S., Calverley, P. M. A., Crook, A. M., Dowson, L., Duffy, N., Gibson, G. J., Hughes, P. D., Hurst, J. R., Lewis, K. E., Mukherjee, R., Nickol, A., Oscroft, N., Patout, M., Pepperell, J., Smith, I., Stradling, J. R., Wedzicha, J. A., … Hart, N. (2017). Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA, 317(21), 2177–2186. https://doi.org/10.1001/jama.2017.4451.
7. AHRQ. “Noninvasive Positive Pressure Ventilation in the Home: Final Technology Assessment” (Feb. 4, 2020).
8. Id. at iii.
9. Vasquez, supra note 5.
10. AHRQ, supra note 6.
11. Id. at iii.
12. Vasquez, supra note 5.
13. Mosher, C. L., Weber, J. M., Adagarla, B. S., Neely, M. L., Palmer, S. M., & MacIntyre, N. R. (2022). Timing of Treatment Outcomes and Risk Factors for Failure of BPAP in Patients Hospitalized for COPD Exacerbation. Respiratory care, 67(12), 1517–1526. https://doi.org/10.4187/respcare.10155.
14. CDC, supra, note 2.
15. LCD. “Respiratory Assist Devices (L33800).” (2017).
16. Mosher, supra note 12.
17. Wedzicha, J. A., & Seemungal, T. A. (2007). COPD exacerbations: defining their cause and prevention. Lancet (London, England), 370(9589), 786–796. https://doi.org/10.1016/S0140-6736(07)61382-8.
18. Mosher, supra note 12.
19. Seemungal TAR, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998;151:1418–1422.

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With regards to the ONMAP TEP published in CHEST 2021 for patients with COPD, I support 1) the removal of overnight oximetry as a qualification requirement and 2) the ability to include a back-up rate when prescribing NIV. The current guidelines have created barriers to care for our most vulnerable patients.
There are additional important considerations. The choice of device should be made by the physician who has a relationship with the patient. Patients with COPD and chronic respiratory failure have proven to be ill-suited to trial-and-error stepwise therapy requirements. Another crucial aspect of device choice is the clinical and technical support provided by a qualified respiratory therapist. Also, arbitrary adherence metrics adopted from sleep apnea therapy, such as requiring at least four hours of nightly use, are not suitable for this population.
Dr. Frazier eloquently addressed these points with peer-reviewed publications as referenced in his comments. I am hopeful that further revisions to the guidelines for all causes of chronic respiratory failure will ease the burden on those caring for a patient population that has faced impediments and inequity in the current environment.

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The American Academy of Sleep Medicine (AASM) is responding to the Centers for Medicare & Medicaid Services (CMS) request for public comments concerning its National Coverage Analysis (NCA) for the reconsideration of NCD 280.1, which addresses coverage policies for the use of non-invasive home mechanical ventilators and respiratory assist devices (RAD) for Medicare beneficiaries with various respiratory conditions. We understand that CMS has accepted a request to examine the indications for chronic obstructive pulmonary disease (COPD) and plans to develop a new NCD section.

The AASM is the only professional organization dedicated exclusively to the medical subspecialty of sleep medicine with a combined membership of 11,000 accredited sleep centers and individual members. Many of our member centers and health care professionals are actively involved in the initiation, titration, and longitudinal support of noninvasive ventilatory (NIV) support in patients in COPD. The AASM appreciates the opportunity to provide comments.

In 2020-2021, the AASM joined with American Thoracic Society (ATS), the American College of Chest Physicians (CHEST), the American Academy of Respiratory Care (AARC) to convene a group of thirty experts, the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel (ONMAP TEP), to examine NIV in COPD. In alignment with the latest clinical evidence, that group submitted the request that modifications to the current NCD are required for COPD patients to ensure that the right COPD patient obtains the right NIV device at the right time.^1-3 The AASM strongly agrees with the proposed changes to the CMS NCD made by ONMAP TEP.

Approximately 24 million Americans are living with COPD. Tragically, COPD remains the 4th leading cause of death in the United States with the Medicare program covering an estimated annual cost of $10.8 billion to treat beneficiaries.4 COPD patients with hypercapnia, defined as a PaCO2 > 45 mmHg, are at increased risk of mortality, particularly when PaCO2 levels rise above 52 mm Hg.^5-7 These concerns have led clinicians to utilize NIV for patients with stable, chronic hypercapnic COPD to reduce hospital admissions, improve patient-reported outcomes, and prolong survival.

Recent clinical trials have demonstrated that patients with stable, chronic hypercapnic COPD treated with high intensity NIV have increased survival, reduced hospitalization, and/or improvements in health-related quality of life.^{2, 3} High intensity NIV is characterized by use of high levels of pressure support (e.g. > 15 cm H2O) in combination with a backup rate (BUR). The positive outcomes observed in these trials have been primarily attributed to the intentional reduction in PaCO2 using this high intensity NIV approach. Recent systematic reviews⁸ and current clinical practice guidelines^{9, 10} recommend the use of high intensity NIV in patients with stable, chronic hypercapnic COPD to target reductions of PaCO2 levels.

Although current CMS coverage policies allow prescribing a RAD without a BUR (E0470), the same policies make it exceedingly difficult to order a RAD with a BUR (E0471), presenting a barrier in achieving optimal outcomes for stable, chronic hypercapnic COPD patients. Patients with stable, chronic hypercapnic COPD only qualify for an E0471 device if they: 1) are on a E0470 device for at least 2 months, 2) demonstrate their PaCO2 remains greater than 52 mm Hg, and 3) sleep oximetry while using the device done while breathing oxygen at 2lpm or the beneficiary’s usual FiO2, whichever is higher. Since the most recent trials demonstrate benefit utilizing E0471 devices, the AASM strongly supports the recommendation to drop the requisite trial of an E0470 device and allow severe COPD patients immediate access to E0471 devices. In addition, as noted by the ONMAP TEP report, the nocturnal oxygen requirement and threshold is not appropriate. Oxygen supplementation during sleep typically restores oxygen to normal levels,¹¹ and would not be expected to correct hypercapnia. Rather moderate-severe hypercapnia persists and is known to be associated with increased mortality risk. Furthermore, clinical trials of NIV in stable, chronic hypercapnic COPD patients have NOT used the CMS sleep oximetry requirement as a study inclusion criterion.^{8, 10} For these reasons, the AASM strongly encourages that the NCA considers elimination of the sleep oximetry requirement.

Clinicians seeking to provide optimal care for these patients have often resorted to prescribing more expensive home mechanical ventilators using non-invasive interfaces (HMV; E0466) due to less restrictive CMS policy criteria, when a E0471 device with volume targeted mode would likely have been sufficient. Nevertheless, there are instances when stable, chronic hypercapnic COPD patients would likely benefit from an HMV device (E0466) including:
1) Persistent hypercapnia > 52 mm Hg despite being on RAD with a BUR (E0471)
2) Respiratory dyssynchrony while using the device
3) Higher oxygen requirements than a RAD device can support
4) Pressure requirements exceed what can be provided in a RAD
5) Requiring backup battery for their device
6) The need for > 10h of respiratory support per day and/or need for mouthpiece ventilation, or
7) When more advance monitoring and sophisticated alarms is necessary.

For these reasons, the AASM strongly encourages that the NCA continue to cover HMV with modifications described in the reconsideration request submitted by the ONMAP TEP on COPD.¹

The NCA also requested commentary on aspects of health disparities and health equity that should be considered in their review. The AASM would highlight several important points. First, the current requirement for use of sleep oximetry to qualify for a RAD with a BUR (E0471) can result in health disparities and inequities. Oximetry has been demonstrated to systematically overestimate oxygen saturation in people with darker skin tones.^12-14 The consequences could be quite significant and could result in false negative determinations of eligibility more frequently in those of Black and/or Hispanic background and result in denials of appropriate therapy. This is another reason why the AASM advocates for elimination of the sleep oximetry requirement.

Second, the requirement for demonstration of RAD use for >4 h per night for >70% of nights in a 30-day period can also result in health disparities and inequities. PAP and NIV are the only therapies where CMS requires documentation of adherence therapy in order to pay a durable medical equipment (DME) company on behalf of the Medicare beneficiary.¹⁵ Much of the data to consider comes from the literature with respect to PAP therapy for obstructive sleep apnea (OSA) and is summarized in a recent policy statement published by the ATS.¹⁵ Several studies have noted reduced PAP adherence in Black vs. non-white participants.^16-19 Furthermore, lower socioeconomic status has also been associated with reduced PAP adherence.²⁰ In addition, regional geographic disparities in PAP adherence has been demonstrated, which may indicate broad systemic issues in geographic variation in availability of resources.²¹ The presence of these disparities in PAP use by racial, ethnic, socioeconomic, or regional status may then require more time to achieve adherence. In addition, and although specific to PAP use for OSA, there are data to support that adherence at lower levels (e.g. >2 h of use/night) can still result in improvement in patient symptoms.^22-25 For these reasons, CMS should consider policy revisions to provide longer periods of time for RAD acclimation. As recommended by the ONMAP TEP and the ATS, a reasonable threshold would be demonstration of use of RAD for at least a mean of 2h/night over two 90-day trial periods would be reasonable before denial of continued coverage of therapy. Furthermore, the AASM also strongly supports the ONMAP TEP’s call for CMS to provide ongoing home support by skilled qualified clinicians (e.g. respiratory therapists) to help patients navigate the intricacies of NIV initial set-up and continuing use, whether E0471 or E0466.

We appreciate the opportunity to provide comments on the NCA solicited by CMS. We strongly encourage CMS, in the future, to also adopt the ONMAP TEP recommendations for revisions to the NCD for coverage of NIV as related to thoracic restrictive disorders, central sleep apnea, and hypoventilation syndrome. We are greatly encouraged that CMS is taking the initiative to consider revisions to the NCD for CMS beneficiaries with chronic, stable hypercapnic COPD in order to improve patient outcomes and healthy equity concerns.

References

1. Hill NS, Criner GJ, Branson RD, et al. Optimal NIV Medicare Access Promotion: Patients With COPD: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021;160(5):e389-e97.
2. Kohnlein T, Windisch W, Kohler D, et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014;2(9):698-705.
3. Murphy PB, Rehal S, Arbane G, et al. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017;317(21):2177-86.
4. Mannino DM, Roberts MH, Mapel DW, et al. National and Local Direct Medical Cost Burden of COPD in the United States From 2016 to 2019 and Projections Through 2029. Chest. 2024;165(5):1093-106.
5. Ahmadi Z, Bornefalk-Hermansson A, Franklin KA, Midgren B, Ekstrom MP. Hypo- and hypercapnia predict mortality in oxygen-dependent chronic obstructive pulmonary disease: a population-based prospective study. Respir Res. 2014;15(1):30.
6. Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996;109(3):741-9.
7. Foucher P, Baudouin N, Merati M, et al. Relative survival analysis of 252 patients with COPD receiving long-term oxygen therapy. Chest. 1998;113(6):1580-7.
8. Wilson ME, Dobler CC, Morrow AS, et al. Association of Home Noninvasive Positive Pressure Ventilation With Clinical Outcomes in Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis. JAMA. 2020;323(5):455-65.
9. Ergan B, Oczkowski S, Rochwerg B, et al. European Respiratory Society guidelines on long-term home non-invasive ventilation for management of COPD. Eur Respir J. 2019;54(3).
10. Macrea M, Oczkowski S, Rochwerg B, et al. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(4):e74-e87.
11. Kim C MN, Criner GJ. Nocturnal hypercapnia and acidosis despite normoxemia in patients hospitalized for exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2016;193:A5190.
12. Burnett GW, Stannard B, Wax DB, et al. Self-reported Race/Ethnicity and Intraoperative Occult Hypoxemia: A Retrospective Cohort Study. Anesthesiology. 2022;136(5):688-96.
13. Fawzy A, Wu TD, Wang K, et al. Clinical Outcomes Associated With Overestimation of Oxygen Saturation by Pulse Oximetry in Patients Hospitalized With COVID-19. JAMA Netw Open. 2023;6(8):e2330856.
14. Jamali H, Castillo LT, Morgan CC, et al. Racial Disparity in Oxygen Saturation Measurements by Pulse Oximetry: Evidence and Implications. Ann Am Thorac Soc. 2022;19(12):1951-64.
15. May AM, Patel SR, Yamauchi M, et al. Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds: An Official American Thoracic Society Policy Statement. Am J Respir Crit Care Med. 2023;207(3):244-54.
16. Billings ME, Auckley D, Benca R, et al. Race and residential socioeconomics as predictors of CPAP adherence. Sleep. 2011;34(12):1653-8.
17. Hsu N, Zeidler MR, Ryden AM, Fung CH. Racial disparities in positive airway pressure therapy adherence among veterans with obstructive sleep apnea. J Clin Sleep Med. 2020;16(8):1249-54.
18. Wallace DM, Williams NJ, Sawyer AM, et al. Adherence to positive airway pressure treatment among minority populations in the US: A scoping review. Sleep Med Rev. 2018;38:56-69.
19. Ye L, Pack AI, Maislin G, et al. Predictors of continuous positive airway pressure use during the first week of treatment. J Sleep Res. 2012;21(4):419-26.
20. Platt AB, Field SH, Asch DA, et al. Neighborhood of residence is associated with daily adherence to CPAP therapy. Sleep. 2009;32(6):799-806.
21. Dunietz GL, Yu Y, Levine RS, et al. Obstructive sleep apnea in older adults: geographic disparities in PAP treatment and adherence. J Clin Sleep Med. 2021;17(3):421-27.
22. Antic NA, Catcheside P, Buchan C, et al. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011;34(1):111-9.
23. Gaisl T, Rejmer P, Thiel S, et al. Effects of suboptimal adherence of CPAP therapy on symptoms of obstructive sleep apnoea: a randomised, double-blind, controlled trial. Eur Respir J. 2020;55(3).
24. McMillan A, Bratton DJ, Faria R, et al. A multicentre randomised controlled trial and economic evaluation of continuous positive airway pressure for the treatment of obstructive sleep apnoea syndrome in older people: PREDICT. Health Technol Assess. 2015;19(40):1-188.
25. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-9.

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From the physicians of the COPD program at the University of Pennsylvania:

We are writing to strongly advocate for removing the nocturnal hypoxemia criterion for qualification of bi-level positive airway pressure (BPAP) devices. There is a growing body of literature suggesting improved patient outcomes (including lower hospitalization rates and possibly reduced mortality) for hypercapnic COPD outpatients receiving high-intensity non-invasive positive pressure ventilation, such as BPAP, which target lowering of carbon dioxide levels. Our group specializes in the treatment and management of patients with COPD, and our clinical practice consists of a large proportion of patients with chronic hypercapnic COPD who would benefit from BPAP devices.

We agree with the prior CMS expert panel reviewing the use of respiratory assist devices (RAD) in COPD (September 2020), noting overuse of home mechanical ventilators, rather than simpler and less expensive BPAP devices which would likely suffice in most patients. Yet, we feel this overuse of home mechanical ventilators is driven by difficulty in meeting CMS criteria for BPAP, specifically the requirement for nocturnal hypoxemia. Thus, we would like to strongly echo the comments of Dr. John Coleman that the solution to the overuse of home mechanical ventilators lies in simplification of the criteria to obtain BPAP devices in COPD, with removal of the nocturnal hypoxemia criterion.

The hypoxemia criterion ignores the fact that hypercapnic respiratory failure is a highly morbid condition, even in the absence of hypoxia on low flow oxygen. In clinical practice, we commonly see patients with significant chronic hypercapnia (defined as PaCO2 =52) with recurrent episodes of acute on chronic respiratory failure requiring intensive care unit admission, but WITHOUT sufficient hypoxemia to meet the current criteria for BPAP qualification. When clinicians encounter such patients, they are left with no choice but to pursue a home non-invasive ventilator or offer no mechanical respiratory support, which is dangerous and life-threatening in these patients.

Simplifying the qualification criteria for BPAP by removal of the hypoxemia on nocturnal oximetry criterion would result in improved outcomes for hypercapnic COPD patients and a reduction in the use of more costly and often unnecessary home mechanical ventilators, which instead should be reserved for patients failing a trial of BPAP.

Respectfully,
The COPD Program at the University of Pennsylvania Health System

Michael W. Sims, MD
Audreesh Banerjee, MD
Maria Basil, MD
Joshua Brotman, MD
Joanna Hart, MD
Janae K. Heath, MD
Arshad A. Wani, MD

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ResMed appreciates the opportunity to provide input in response to the Center for Medicare & Medicaid Services (CMS) Coverage and Analysis Group (CAG) National Coverage Analysis (NCA) request for comment on Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) consequent to COPD.

ResMed is a pioneer of digital innovative solutions that transform care to treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives at home. We are focused on sleep and related chronic respiratory care, both of which we believe are globally underpenetrated, and where we believe our products can improve patient outcomes, create efficiencies for our durable medical equipment “DME” customers, help physicians and providers better manage chronic disease and reduce overall healthcare system costs. Our cloud-connected medical devices and digital health technologies transform care for people with sleep apnea, chronic obstructive pulmonary disease (COPD), and other chronic diseases.

As a leading manufacturer of innovative NIPPV technology, we respectfully provide our insights and recommendations in response to this request for comment to ensure a comprehensive understanding of the best available clinical evidence to guide prescribing and usage of these life-enhancing devices for Medicare beneficiaries. Our comments are intended to support CMS’ efforts by emphasizing the importance of the clinical relationship between the range of ventilation technology that provide NIPPV therapy.

Full Spectrum of Technology Solutions Available for a Broad Range of Clinical Scenarios
A growing body of peer-reviewed literature supports the provision of Home Noninvasive Positive Pressure Ventilation (NIPPV) to patients with COPD and CRF, based on proven clinical outcomes such as improved gas exchange, better quality of life, reduced hospital readmissions as well as reduced mortality.^1,2 NIPPV, refers to a method of providing breathing support without the need for invasive procedures or interfaces. The term NIPPV was previously used to distinguish it from noninvasive negative-pressure ventilation ³, but given the latter's rarity nowadays, the simpler term Noninvasive Ventilation (NIV) is more convenient and will be the one used throughout our comments.

NIV can be delivered to patients through a variety of therapy modes and different devices that can broadly be classified in 2 groups – Bilevel devices (BPAP or RADs as termed by Medicare HCPCS codes E0470, E0471, E0472) and Home Ventilators (HMV - HCPCS codes E0465, E0466, E0467, E0468).⁴ Patients with COPD and chronic hypercapnia are known to vary in their level of ventilator dependence. Many patients are non-dependent and receive ventilation to suppress COPD symptoms and minimize the risk of exacerbation ^5,6 However, device dependency can increase as the disease worsens, and some patients progress to become severely or totally dependent on mechanical ventilation as a form of life support.^6,7 While the average patient may be recommended for = 4 hours of NIV therapy per day, highly dependent patients may require ventilation for =10 hours per day.⁸ Stronger airflow may also be needed to counteract more severe airway obstruction associated with advanced disease.⁹

The relationship between bilevel devices (identified as Respiratory Assist Devices (RADs) by CMS) for treatment of respiratory insufficiency and home mechanical ventilators for treatment of chronic respiratory failure are inextricably linked. Some Medicare beneficiaries may need a home mechanical ventilator without any previous use of a bilevel device; likewise, clinical outcomes can be achieved with the use of bilevel devices for other Medicare beneficiaries. There is also a significant portion of the Medicare population that experiences a shift in the level of mechanical support needed as their illness(es) progress.

The respiratory support needs of these patients may vary depending on environmental factors, activity levels, comorbidities and progression of disease. Chronic respiratory failure, as defined and documented, occurs across different Medicare populations at different rates and access to different types of equipment specific to the patient is medically reasonable and necessary. Patients with chronic and progressive respiratory disorders require advanced ventilatory capabilities as their disease progresses. Selection and administration of NIPPV devices in an efficient, evidence-based manner—as directed by clinicians—is important in striking an optimal balance between quality and effectiveness of care and cost.

This is a complicated area of medical practice and therefore, the broad range of clinical scenarios and coverage policies must be flexible and considered in totality to ensure patients have access to the right device at the right time as determined clinically appropriate by the physician.

Consideration of Recent Evidence and Guidelines
In patients with chronic hypercapnic COPD, NIV plays a critical role in reducing the work of breathing and improving respiratory mechanics through several pathophysiologic abnormalities present in severe COPD.¹⁰ Pharmacological interventions for COPD have limited benefit for patients with chronic hypercapnia; primarily aiming to control symptoms and reduce the frequency of exacerbations to a modest extent.¹¹ Home NIV is then often prescribed for stable hypercapnic COPD patients, at heightened risk of severe exacerbations and mortality. Long-term NIV offers clear benefits in terms of symptom relief, improved survival, and reduced number of hospitalizations due to exacerbations for patients with advanced COPD and chronic hypercapnia.^12,13,14

Recent scientific knowledge, clinical experience and technological innovations have substantially advanced our understanding of the role of NIPPV in the management of COPD for patients with CRF. While HMV and BPAP are distinct devices with different technical features, they have overlapping capabilities that can offer significant benefits to patients with COPD and CRF. The key to optimizing outcomes lies in selecting the right devices and configuration based on each patient’s unique clinical profile. It is not solely the features of the BPAP or HMV that provide the benefit, but the tailored application of features in those devices to meet specific patient needs, such as disease severity, rate of disease progression, respiratory mechanics, and tolerance to therapy. Given that no direct controlled, prospective studies exist comparing bilevel devices to HMVs we suggest caution against extrapolating conclusions based on indirect comparisons. Nonetheless, evidence shows that home use of bilevel therapy compared to no device significantly reduces mortality and hospital admissions. Similarly, the use of HMVs has been associated with lower hospital admissions rates when compared to no device.¹²

Comments on Step Therapy Protocols and Criteria
We believe it would be clinically inappropriate to presume that there is a standard amount of pressure, time, or other therapy features applicable to all Medicare beneficiaries. The reality is that CRF consequent to COPD has disparate causes, and patients are heterogeneous in their response to treatment. Patient usage parameters will vary depending on their clinical manifestations, disease progression, and underlying comorbidities.¹³ Clinicians must have the ability to choose appropriate equipment for each patient. COPD is a chronic disease that worsens over time; a patient’s needs will change over time. Therefore, we respectfully suggest that requiring all patients with CRF due to COPD to start on a bilevel device and only when it proves to be inappropriate, be granted access to an HMV, is not an inclusive or equitable policy.

Notably, current guidelines on the use of Home NIV for patients with COPD and CRF do not provide recommendations on the patient usage parameters necessary to achieve success and desired clinical outcomes.^14,15 In the absence of evidence that a one-size-fits-all approach exists for this patient population, defining patient usage parameters will unnecessarily limit patient access to treatments without improving outcomes. Clinical stakeholders have uniformly criticized length of usage as a criterion for qualification for therapy initiation or continuity.¹⁶

When used inappropriately (for example solely to manage cost of care), step therapy protocols can delay necessary treatment and lead to adverse reactions that ultimately increase rather than lower health care costs. Early Initiation of non-invasive ventilation at home improves survival and reduces healthcare costs in COPD patients with chronic hypercapnic respiratory failure.¹⁷ Step therapy bypasses what the physician believe is the best, clinically appropriate treatment for their patient. It can also increase the administrative burden of denials and appeals.

CMS Should Consider LCD and NCD Together
The importance of a personalized approach is the anchoring belief of all the ONMAP (Optimal NIV Medicare Access Promotion) articles, which we understand formed the basis of this reconsideration request, to provide processes to obtain the “right device for the right patient at the right time.” ¹⁸ To that end ResMed respectfully requests that the Centers for Medicare & Medicaid Services consider reviewing and addressing the Local Coverage Determination (LCD) for Respiratory Assist Devices (RADs) before finalizing any changes to the National Coverage Determination (NCD) for Non-Invasive Positive Pressure Ventilation (NIPPV); in our view the two policies should go hand in hand.
HMV and BPAP devices are covered under different coverage policies. To appropriately address this question across the spectrum of NIPPV technology, both the national coverage determination (NCD) ¹⁹ for HMVs and the local coverage determinations (LCDs) must be addressed together.²⁰

The LCD governing RADs plays a critical role in the management of patients with COPD-CRF. Given the overlap in clinical usage and the potential implications of NCD revisions, we believe it is important to first evaluate the existing RAD LCD to ensure that its provisions align with the most current clinical evidence and patient needs. This sequential review would allow CMS to approach NIPPV coverage decisions with a clearer understanding of how RADs are being utilized, particularly in COPD patients, and whether any gaps or redundancies exist between these two policies. Ignoring this critical intersection of policy may lead to harmful access issues for Medicare patients.

Closing
In closing, ResMed appreciates CMS' careful consideration of the complexities surrounding the use of Noninvasive Positive Pressure Ventilation (NIPPV) for patients with chronic respiratory failure (CRF) resulting from COPD. We believe that maintaining flexibility in coverage policies, along with an evidence-based approach, will allow physicians to tailor therapy to each patient’s unique needs, ensuring equitable access to life-enhancing technologies. We respectfully urge CMS to align its coverage determinations across both national and local policies to support optimal patient outcomes and reduce healthcare costs. Thank you for the opportunity to provide these comments in support of Medicare beneficiaries' health and quality of life.

References
1. Orr, JE. Home Noninvasive Ventilation for COPD. Respir Care. 2023; 68(7): 1013–1022.
2. Köhnlein, T et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014; 2(9):698-705.
3. Gong Y, et al. Noninvasive Ventilation. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK578188/
4. Coleman 3rd, JM et al. Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019;16(9):1091-1098.
5. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2024.
6. Collaborators GBDCRD. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med 2017; 5(9): 691-706.
7. G. B. D. Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100): 1151-210.
8. Purro A, Appendini L, De Gaetano A, Gudjonsdottir M, Donner CF, Rossi A. Physiologic determinants of ventilator dependence in long-term mechanically ventilated patients. Am J Respir Crit Care Med 2000; 161(4 Pt 1): 1115-23.
9. Janssens JP, Michel F, Schwarz EI, et al. Long-Term Mechanical Ventilation: Recommendations of the Swiss Society of Pulmonology. Respiration 2020: 1-36.
10. Csoma, B, et al. Hypercapnia in COPD: Causes, Consequences, and Therapy. J Clin Med. 2022; 11(11): 3180.
11. Lee HW, Park J, Jo J, Jang EJ, Lee CH. Comparisons of exacerbations and mortality among regular inhaled therapies for patients with stable chronic obstructive pulmonary disease: Systematic review and Bayesian network meta-analysis. PLoS Med 2019; 16(11): e1002958.
12. Wilson, ME, et al. Association of Home Noninvasive Positive Pressure Ventilation with Clinical Outcomes in Chronic Obstructive Pulmonary Disease. A Systematic Review and Meta-analysis. JAMA. 2020;323(5):455-465.
13. Rennard, SI. COPD Heterogeneity: What This Will Mean in Practice. Respiratory Care 2011; 56 (8) 1181-1187
14. Macrea M, et al. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;15;202(4): e74-e87.
15. Ergan B, Oczkowski S, Rochwerg B, et al. European Respiratory Society Guideline on Long term Home Non-Invasive Ventilation for Management of Chronic Obstructive Pulmonary Disease. European Respiratory Journal 2019; 28;54(3):1901003
16. May AM, et al. Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds: An Official American Thoracic Society Policy Statement. Am J Respir Crit Care Med 2023; 207 (3): 244- 254
17. Frazier WD, et al. Early Initiation of non-invasive ventilation at home improves survival and reduces healthcare costs in COPD patients with chronic hypercapnic respiratory failure: A retrospective cohort study. Respiratory Medicine 2022; (200) 106920
18. Hill NS, et al. Optimal NIV Medicare Access Promotion: Patients With COPD. A Technical Expert Panel Report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. CHEST 2021; 160 (5): e389 - e397
19. Centers for Medicare & Medicaid Services. National Coverage Analysis (NCA) for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N) [Internet]. Baltimore: Centers for Medicare & Medicaid Services; c2024 [updated 2024 Sep 11; cited 2024 Oct 9]. Available from: https://www.cms.gov/medicare-coveragedatabase/view/nca.aspx?ncaid=315&doctype=all&timeframe=30&sortBy=updated&bc=21
20. Centers for Medicare & Medicaid Services. Local Coverage Determination (LCD): Respiratory Assist Devices (L33800) [Internet]. Baltimore: Centers for Medicare & Medicaid Services; c2024 [revision effective date 2024 Jan 01; cited 2024 Oct 9]. Available from: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33800

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I am strongly supporting alterations in the current guidelines for covering use of EO470 devices for patients with hypercapnic stable COPD (PaCO2 >or= to 52 mmHg. Specifically, I support removing the requirements that nocturnal oximetry reveal a cumulative 5 min with O2sat Less

MEDICARE COUNCILS’ A, B, C and D RESPIRATORY WORKGROUP

The Councils for all four jurisdictions are responding to CMS’ request for comments related to the RAD reconsideration.

The reconsideration proposes changes to two different NCDs. Before CMS makes any changes to the current ventilator NCD, especially any restrictions that could create additional barriers which restrict beneficiaries to accessing the appropriate device (such as the initiation of NIPPV with a home mechanical ventilator (HMV)), CMS should allow the time necessary to carefully assess the impact.

While an important step, the current 30-day comment period is simply not enough time for a complete review, particularly in light of the current review of the RAD LCDs that interact with the NCD.

The council urges CMS to pause the reconsideration related to the HMV NCD to allow time for technical assessment with more clinical data. In addition, the industry needs to understand the potential changes forthcoming to the RAD NCD and LCD before any recommendations and comments can be made to a separate NCD for HMV.

During the councils review of the RAD reconsideration, the council agrees with the following recommendations:

1. When there is a diagnosis of COPD, to eliminate the overnight oximetry-saturation requirement.
2. Hypoventilation should not be referred to in the CSA category.
3. To allow CPAP as therapy for CSA when it is shown to be effective.
4. To remove any requirements that a beneficiary must first try a BIPAP with a backup rate.
5. Remove the requirement of a sleep study to rule out OSA when there is a diagnosis of COPD.

The Councils want to thank you for providing us with the opportunity to submit comments. Some of our members are clinicians, but most are home medical equipment suppliers who engage daily with patients and their families to support the treatment modalities selected by their physicians and practitioners. We are the ones working the physicians and patients to provide access to the therapy necessary to treat the patients in their home 24/7.

Most importantly, CMS should prioritize patient access over cost concerns in relation to the initiation of NIPPV therapy with an HMV device to avoid the serious morbidity, additional hospitalizations, and increased mortality associated with patients failing to respond to treatment.

CMS should avoid adopting new policies in isolation of the RAD LCDs reconsideration.

We welcome the opportunity to participate in the ongoing dialogue to ensure that beneficiaries receive the right treatment, at the right location, and at the right time.

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Introduction:

Re: COMMENTS IN RESPONSE TO CMS’ REQUEST FOR PUBLIC COMMENT REGARDING RECONSIDERATION AND REVISION OF § 280.1 OF THE NATIONAL COVERAGE DETERMINATIONS MANUAL, DURABLE MEDICAL EQUIPMENT REFERENCE LIST: VENTILATORS, (PUB. 100-03, PART 4, CHAPTER 1)

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Jensen,

My name is Nicole Rodriguez, and I bring 20 years of experience in the post-acute care sector, with firsthand knowledge of the significant benefits that patients derive from in-home respiratory medical devices such as Home Mechanical Ventilators (HMV). Throughout my career, I have witnessed substantial improvements in patients' disease burden and overall health outcomes, particularly those suffering from chronic respiratory conditions such as COPD, through the effective provision and management of these devices.

The current policy restricts access to ventilators for COPD patients and limits physicians' ability to make individualized determinations based on their patients' needs, highlighting the critical need for policy adjustments to better serve this population. Consistent care across all DME MAC regions is crucial to ensuring fair and just treatment for all patients. Therefore, an updated NCD is essential to safeguard access to these vital therapies. The ability to manage high-acuity COPD patients in the home setting significantly reduces the overall cost and resource burden on the healthcare system [1} . This access must be protected through updates to the NCD and not left to the discretion of local MACs via LCD policies.

The following remarks are provided in response to the recommendations submitted by the TEP concerning NCD 280.1

Areas of Support:
I support the the following recommendations outlined in the TEP recommendations:

1. Elimination of pulse oximetry studies from any qualification criteria for home mechanical ventilation with or without supplemental O2.
2. The prescribing clinician should have the authority to determine the appropriate timing for initiating a specific respiratory therapy device. NIPPV should be based on the discretion of the prescribing clinician where COPD and Chronic Respiratory Failure (CRF) are concerned.
3. For patients with a diagnosis of COPD, elimination of the requirement for a sleep study to rule out obstructive sleep apnea (OSA).
4. Establishment of separate coverage and reimbursement for respiratory therapist (RT) services provided in the home.
5. Inclusion of criteria for coverage of HMV (NIV) when the need for alarms, batteries, service, mouthpiece ventilation, and/or multiple preset prescription therapy modes.

Areas of Concern:
I do not support the following recommendations outlined in the TEP recommendations as they are currently written:

1. ABG of PaCO2> 52 mmhg to confirm COPD
   1. A PaCO2 of >45 mmHg should be utilized to define hypercapnia, in accordance with NIH guidelines.
   2. The TEP recommendations fail to adequately consider the use of alternative post-acute methods for assessing CO2 levels, such as End-Tidal CO2 (EtCO2), Transcutaneous CO2 (TcCO2), or Venous Blood Gas (VBG). Even in acute care settings, many facilities now prioritize VBG over Arterial Blood Gas (ABG) as a primary measure for patient evaluation.
2. OSA and CPAP “Considered” Requirement
   1. The diagnosis and management of obstructive sleep apnea (OSA) and the use of CPAP therapy should not be considered relevant for patients with COPD and Chronic Respiratory Failure (CRF). A requirement to “consider” these issues as it relates to the determination to prescribe NIPPV is not for this population should be removed.
   2. The recommendations put forth by the TEP may lead to delays in care or create confusion for prescribing physicians, particularly in cases of "Overlap Syndrome," where a patient is affected by both sleep-disordered breathing and COPD. Such situations require nuanced clinical judgment, and overly rigid guidelines could hinder timely and appropriate treatment decisions.
3. HMV Consideration Criteria Concerns
   Initiation of HMV (NIV) should be solely at the discretion of the patient's physician and aligned with the specific disease burden and progression of the patient. While on the surface the recommendations below make sense, I do not agree with the following recommendations as written for the following reasons:
   1. The formal request does not define the number of clinical criteria for coverage of an HMV (NIV); it should be first at the discretion of the physician, but secondarily to “one or more” of the outlined criteria
   2. Higher pressures than those deliverable by E0471
      1. Equating the pressure settings of a therapy device with the severity of a patient's condition is not appropriate, as higher pressure levels do not necessarily correspond to increased severity of COPD.
      2. The effectiveness of the device may be more influenced by its modes and advanced settings, which enhance synchronization between the device and the patient, as well as the availability of multiple preset therapy modes, rather than by pressure levels alone.
   3. FIO2 higher than 40% or 5 L/min nasally, which is greater than can be supplied by E0471
      1. COPD is a ventilatory issue, not an oxygenation issue. As such, consideration for initiation of HMV (NIV) treatment for COPD should not even take into account oxygen liter flow. While oxygen dependency often goes hand in hand with COPD treatment, it is not an indication of the severity of the ventilator defect. HMV (NIV) is indicated to improve and stabilize gas exchange in COPD patients with chronic respiratory failure. This is a very different clinical strategy compared to prescribing supplementary oxygen which only improves blood oxygen saturation levels but does not improve gas exchange by lowering blood carbon dioxide levels and stabilizing blood pH.
   4. Ventilator support for 10 h per day or greater (ie, daytime use)
      1. The figure of “10 h” per day is a somewhat arbitrary figure that is not clinically supported. The 10 hour metric should not restrict patients who demonstrate less usage from receiving HMV(NIV) should their physician determine it as necessary therapy to address the condition.

Additional Comments/Recommendations:

1. Clinical Services Reimbursement
   1. I support separate coverage and payment for clinical services in the home for this patient population. At present, however, there is no separate Medicare coverage and payment available to a DME provider for clinical services provided to patients in the home. CMS should consider updating policy to include payment for services associated with the complex and comprehensive management of patients in the home.
2. Timely Access to Therapy
   1. The criteria should not be so burdensome as to create a barrier that effectively prevents the use of a ventilator and a clinician’s ability to order the ventilation therapy. Burdensome criteria will likely increase patient length of stay, disrupting the discharge process.
3. 3. Diagnostic Criteria
   1. Clinical and/or acceptance criteria should not be limited to available objective testing such as ABG. Recommend using other measures as well, such as:
   2. VBG, ETCO2, or TcCO2
   3. PFT (with other qualifying indicators – ex. chart notes documenting of Chronic Resp Failure and PFT)

Support for Previous Comments:
I also endorse the following comments and references submitted by others to CMS, recommending an update to the NCD for the use of NIPPV in the treatment of COPD with Chronic Respiratory Failure:

1. Indicate NIPPV coverage for hypercapnic COPD-CRF patients who have an elevation of PaCO2 above the upper limit of normal.
2. State that NIPPV should be initiated as soon as possible following the diagnosis of hypercapnic COPD-CRF.
3. State that the choice of device is at the discretion of the prescribing healthcare provider, and not require patients to try and fail BPAP/RAD therapy before coverage is provided for an HMV (NIV).
4. Not require an arbitrary “hours of use” metric for continued NIPPV coverage. While adherence to NIPPV is important to optimize outcomes, the minimal usage necessary to achieve this is unknown. Any use is enough use for the patient to keep the equipment.
5. Not require patients to requalify for NIPPV. Hypercapnic COPD-CRF is a persistent disease with no known cure, so requalification is an unnecessary burden and wastes health care resources.
6. Not require overnight oximetry or sleep tests to qualify hypercapnic COPD-CRF patients for NIPPV.
7. Not implement requirements that stand to worsen health equity among Medicare beneficiaries. Hypercapnic COPD-CRF is more common in African Americans and in economically disadvantaged people. Any NCD changes that limit access to NIPPV will disproportionately affect these groups.

Conclusion:
I appreciate the opportunity to provide feedback regarding the current TEPs recommendations. The goal for the entire clinical community should be to provide efficient and effective care to patients impacted by chronic illness. CMS should support, not limit, therapies in the post acute space that create margin for the system, through reduced readmissions and improved patient outcomes.
Sincerely,
Nicole Rodriguez, RCP
Director of Respiratory Care
Supercare Health

References:

1) Coughlin S, Peyerl FW, Munson SH, Ravindranath AJ, Lee-Chiong TL. Cost Savings from Reduced Hospitalizations with Use of Home Noninvasive Ventilation for COPD. Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2017;20(3):379–87

2)Amilkar Almaza-Hurtado et al., Hypercapnia from Physiology to Practice, Int. J. Clin. Pract. (2022) https://doi.org/10.1155/2022/2635616.

3) Peter C. Gay and Robert L. Owens, Formal Request for Reconsideration of § 280.1, Durable Medical Equipment Reference List: Ventilators, Pub 100-03, Part 4, Chapter 1 (September 9, 2021) chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cms.gov/files/document/id315.pdf.

4) Schwartz W.B., Brackett N.C., Jr., Cohen J.J., The response of extracellular hydrogen ion concentration to graded degrees of chronic hypercapnia: the physiologic limits of the defense of pH, J Clin Invest. (1965) https://dm5migu4zj3pb.cloudfront.net/manuscripts/105000/105143/JCI65105143.pdf.

5) William D. Frazier et al., Early Initiation of non-invasive ventilation at home improves survival and reduces healthcare costs in COPD patients with chronic hypercapnic respiratory failure: A retrospective cohort study Resp Med (2022) https://doi.org/10.1016/j.rmed.2022.106920.

6) Michael E. Wilson et al., Association of Home Noninvasive Positive Pressure Ventilation with Clinical Outcomes in Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis, 323 JAMA 455, 461 (2020).

7) Nicholas S. Hill et al., Optimal Noninvasive Medicare Access Promotion: Patients with COPD: Technical Expert Panel Report from the American College of Chest Physicians, the Association for Respiratory Care, the American Academy of Sleep Medicine, American Thoracic Society, 160 CHEST J. E389 (2021).

8) Madalina Macrea et al., Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease: An Official American Thoracic Society Clinical Practice Guideline, 202 Am. J. of Respiratory & Critical Care Med. 74, 2183 (2020).

9) Marieke L. Duiverman et al., Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: A randomized controlled trial, 12 Respir. Res. 112 (2011).

10) Marieke L. Duiverman et al., Nocturnal non-invasive ventilation in addition to rehabilitation in hypercapnic patients with COPD, 63 Thorax 1052 (2008).

11) Marieke L. Duiverman et al., Impact of High-Intensity-NIV on the heart in stable COPD: a randomised cross-over pilot study, 18 Respir. Res. 76 (2017).

12) V. Dura et al., Chronic respiratory failure in patients with chronic obstructive pulmonary disease under home noninvasive ventilation: Real-life study, 24 Pulmonology 280 (2018).

13) Patrick B. Murphy et al., Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial, 317 JAMA 2177, 2181-84 (2017).

14) William D. Frazier et al., Non-invasive Ventilation at Home Improves Survival and Decreases Healthcare Utilization in Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease with Chronic Respiratory Failure, 177 Respiratory Med. 106291, 106293-95 (2020).

15) Kohnlein et al., Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease: A Prospective, Multicentre, Randomised, Controlled Clinical Trial, 2 Lancet Respiratory Med. J 698 (2014)

16) Grace McDowell, et al., Assistive Technologies for Home NIV in Patients with COPD: Feasibility and Positive Experience with Remote-Monitoring and Volume Assured Auto-EPAP NIV Mode, 8 BMJ Open Respiratory Research 000828 (2021)

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Thank you for the opportunity to comment on this important recommendation document. Please consider the following:

1. As a device manufacturer we applaud the focus on patient safety. It is well known that reduced paperwork burden, reduced administrative complexity, and broader reliance on the judgement of physicians as opposed to overly specific regulations promotes better health outcomes.
2. We endorse the concept that treatment decisions and associated reimbursement should be based on the specifics of individual patients and their clinical complexities rather than the device utilized to optimally treat them. This means that appropriate reimbursement for physicians, respiratory therapists and other skilled caregivers should be available throughout the continuum of care, including at home. Providers of home care (DME providers and home health providers) are a crucial part of the continuum of care in the US healthcare system and any decision should align with reliable reimbursement pathways and more reasonable administrative burden.
3. We endorse the concept that management of hypercapnia should be a primary focus of management of COPD patients and persistent daytime hypercapnia should promote of escalation of care. Recurrent hospitalizations requiring management of hypercapnia should also be a qualifier for escalation of care.
4. We encourage CMS to avoid being highly prescriptive in the modalities or range(s) of settings for devices, rather to focus on capacity to achieve desired clinical performance. While developing technology should never step backward in clinical capability, requiring future devices to adhere to exact engineering specifications of current devices could inadvertently limit innovation.
5. We remind CMS of the dangers of being highly specific regarding devices in a market of collapsing numbers of manufacturers where the dangers of such specificity in supply chains was so recently made evident. Given the additional safety inherent in associated FDA regulatory processes, questions of reimbursement should remain focused on clinical application and outcomes.
6. We encourage consideration of expansion of the frequent and substantial servicing (FSS) reimbursement pathway. While it is well accepted that more complex machines require service, it is also true that patients with more complicated disease processes require more frequent and skilled care regardless of the devices they use. Providing this service early and at home is not only better for the patient’s clinical outcomes and quality of life, but it is also more cost effective for the health care system.
7. It is well known that COPD is a progressive disease without cure, which renders “requalification” an exercise in administrative burden. Requirements for overnight sleep studies, requalification, and any other barriers which are likely to disproportionately impact vulnerable populations including those in more challenged socioeconomic classes, rural populations, and/or persons of color should be removed.

Thank you for your dedication to patient care.

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Based on the scientific evidence, I support the ONMAP recommendations published in CHEST 2021. Their mantra of getting the right patient the right device at the right time will improve patient care and reduce cost. This approach will reduce rehospitalization in patients with hypercapnic severe COPD and will also reduce cost because clinicians will order less home mechanical ventilators in favor of cheaper devices that can deliver volume-targeted pressure support or bilevel PAP with a back up rate (RAD devices).

I would like to eliminate the need for overnight O2 testing.

Lastly, I believe the changes proposed by ONMAP for patients with obesity hypoventilation syndrome should also be implemented in order to reduce the burden of obtaining appropriate RAD devices (volume targeted pressure support with back up rate or bilevel PAP ST). The proposed changes by the TEP ONMAP will reduce rehospitalizations in patients with hypoventilation and will reduce the need for clinicians to order more expensive home mechanical ventilators.

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The COPD Foundation represents the millions of Americans who have been diagnosed with COPD and the millions more living with the condition who are not yet diagnosed. We support the revision of section 280.1 of the National Coverage Determinations (NCD) Manual (Pub. 100-03, Part 4, Chapter 1) regarding coverage of noninvasive positive pressure ventilation (NIPPV) in the home for the treatment of chronic respiratory failure consequent to COPD (reference code CAG-00465N) as requested by our colleagues on the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel (TEP). Current qualification criteria place an undue burden on clinicians and do not represent current best practices with evidence-based care. These issues place Medicare beneficiaries at risk for additional morbidity, unnecessary utilization of the healthcare system, and death.

As noted in the revision request, the requirement for a beneficiary to be chronically hypoxemic has no basis in physiology. While continuous positive airway pressure (CPAP) therapy has some utility in remediating hypoxemia, the primary goal of NIPPV is to decrease PaCO2 levels and reduce the load on the respiratory musculature. This is particularly important in patients with more advanced cases of COPD as it allows them to have more effective rest, thereby reducing their daytime symptom burden. Many people with elevated PaCO2 (hypercapnia) never desaturate, which would exclude them from accessing this therapy despite clinical and scientific evidence supporting the likelihood of benefit.

In addition, hypercapnia has been demonstrated to have deleterious effects on airway inflammation, immune response, and pulmonary circulation (notably, increasing the risk of pulmonary hypertension), as well as a variety of systemic effects (Csoma et al., https://doi.org/10.3390/jcm11113180). This places patients at much higher risk for worsening symptoms, acute exacerbations of COPD, and the development of additional comorbid conditions. We therefore assert that the eligibility criterion requiring evidence of hypoxemia is economically unwise, clinically unwarranted, and ethically unsound.

We also support the TEP’s request for more flexibility with device selection. As they note, the term “respiratory assist device” is solely an administrative construct and it is increasingly difficult to categorize modern ventilation equipment distinctly as either bilevel positive airway pressure support devices or home mechanical ventilators. Maintaining this artificial separation creates another unnecessary barrier to providing the most appropriate therapy at the most appropriate time. As stated above, such barriers can substantially increase the risk of adverse events and negative effects on a patient’s quality of life.

Finally, we reinforce the TEP’s call for establishing a methodology for providing ongoing clinical support for patients receiving NIPPV. COPD with chronic hypercapnia is a complex condition and this population is medically fragile. Adapting to NIPPV often requires significant training, frequent adjustment, and encouragement to optimize adherence. Face-to-face support from experienced clinical experts (such as respiratory therapists) is essential to optimize outcomes. In addition, these additional touchpoints can potentially help people better manage other aspects of their condition, leading to greater improvements in health status. It is the standard of care in both clinical research and clinical practice in most of the world. Medicare beneficiaries deserve no less.

We appreciate the opportunity to comment on this National Coverage Analysis and advocate on behalf of the sickest and most vulnerable people in the COPD population. We hope that these comments will help inform policies that improve access to care and better align this NCD with the ongoing reviews of Local Coverage Determinations being undertaken by DMEMACs across the country.

Thank you for your consideration.

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October 10, 2024

Tamara Syrek Jensen, JD Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244

Submitted via: Medicare Coverage Data Submit Public Comments

Re: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD

Dear Ms. Jensen,

On behalf of the American Thoracic Society, thank you for the opportunity to comment on the National Coverage Determination process for Noninvasive Positive Pressure Ventilation (NIPPV). The American Thoracic Society is the world's leading medical society dedicated to accelerating the advancement of global respiratory health through multidisciplinary collaboration, education, and advocacy. Core activities of the Society’s more than 16,000 members are focused on leading scientific discoveries, advancing professional development, impacting global health, and transforming patient care. Key areas of member focus include developing clinical practice guidelines, hosting the annual International Conference, publishing four peer-reviewed journals, advocating for improved respiratory health globally, and developing an array of patient education and career development resources. Our members are thought leaders in the treatment of pulmonary disease, critical care illness and sleep disordered breathing. As experts in pulmonary, critical care illness and sleep disordered breathing our patients are directly impacted by Medicare coverage policy for all NIPPV devices.

We offer the following comments on the CMS proposed NIPPV NCD.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality in the world and is the fifth leading cause of death in the United States. Despite progress in the treatment of symptoms and prevention of acute exacerbations, few advances have been made to ameliorate disease progression or decrease mortality. To date, the only therapeutic interventions known to reduce mortality in COPD are smoking cessation and long-term treatment with continuous supplemental oxygen for patients who have severe hypoxemia at rest. However, there is renewed interest in the use of non-invasive ventilation for those with chronic stable hypercapnia, as recent randomized controlled trials (RCTs) show improved mortality and quality of life. For example, the landmark high quality RCT by Kohnlein and colleagues (Lancet Respiratory Medicine) found mortality was substantially (and significantly) lower in patients using nocturnal bi-level positive airway pressure (BPAP) compared to those who were otherwise optimally medically managed without BPAP (1 year mortality 12% in the BPAP group vs. 33% in the control group) (1). In addition, BPAP also improved quality of life. Similar robust findings in the HOT-HMV trial (2) led the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to recommend the use of non-invasive ventilation for those with stable hypercapnic COPD in clinical practice guidelines.(3,4) The ATS and ERS clinical practice guidelines use a rigorous process to survey and interpret the literature, which aligns with best practices set forth by the National Academy of Medicine. In addition, well-done systematic reviews and meta-analyses have also confirmed the effectiveness of non-invasive ventilation among patients with stable hypercapnic COPD.(5) Non-randomized but real world studies in the US have confirmed that early use of non-invasive ventilation (NIV) is associated with reduced emergency department (ED) visits, hospitalizations and mortality.(6) It is important to note that unlike earlier studies on BPAP in hypercapnic COPD patients that did not clearly demonstrate a therapeutic benefit (e.g. McEvoy RD et al Thorax 2009(7)), recent trials including Kohnlein and Murphy utilized a more aggressive ventilatory support strategy (high inspiratory pressures and respiratory rates with an E0471 device) with a goal to normalize the partial pressure of carbon dioxide (PaCO2). In contrast to an E0470 device which does not permit the manipulation of respiratory rate, an E0471 device enables setting a high back-up respiratory rate to achieve normal PaCO2 levels. As such, both the ATS and ERS clinical practice guidelines have recommended the use of an aggressive strategy to normalize PaCO2 that requires use of an E0471 device.

In 2020-2021, The ATS, the American College of Chest Physicians (CHEST), the American Academy of Sleep Medicine (AASM), and the American Academy of Respiratory Care sponsored a technical expert panel of thirty experts to address the use of NIV in COPD as well as other illnesses. This panel convened and specifically considered best practices for the use of NIV in COPD and proposed changes to the CMS national coverage determinations to ensure optimal care for patients, reflecting the latest scientific evidence. (See references 8,9.) Thus, national experts thoroughly familiar with the literature made the following recommendations that the ATS strongly supports:

1) The most recent clinical trials showing benefit utilized BPAP devices with a backup rate (E0471). Thus, we strongly recommend that patients meeting criteria for NIV therapy have immediate access to such devices, and NOT be required to first try (and fail) the use of an E0470 device.

2) Current guidelines require patients to undergo overnight oximetry to document hypoxemia prior to qualifying for BPAP therapy. There is no clear scientific rationale to document hypoxemia in a patient with demonstrated hypercapnia. Patients with COPD and elevated resting PaCO2 (>52mmHg) show persistent hypercapnia despite supplementary oxygen to address hypoxemia.(10) Moreover, there was no oximetry requirement imposed for treatment in the HOT-HMV or other RCTs that have clearly demonstrated a treatment benefit with NIV therapy. Further, the availability, ease of access, and technical limitations of oximetry testing may serve as a barrier by augmenting disparities in care. The use of oximetry may also perpetuate racial disparities in treatment of COPD with respiratory failure. Oximetry systematically overestimates oxygen saturation in people with dark skin tones. As a result, unrecognized low blood oxygen saturation or “occult hypoxemia” is roughly twice as common in Black vs. White patients.(11,12) Consequently, for the same severity of illness, the National Coverage of Determination (NCD) oximetry requirement leads to false negative eligibility assessments, disproportionately more so in Black and Hispanic patients, resulting in a greater risk of denial for appropriate therapy. We therefore strongly recommend eliminating the criterion for overnight oximetry as a requirement to qualify for BPAP therapy.

3) Similarly, some patients are simply too sick to consider the use of an E0471 BPAP device, and require a home mechanical ventilator. The expert panel suggested that a home mechanical ventilator could be considered when any of the following is needed:
a. Higher inspiratory pressures than those deliverable by E0471
b. Fraction of inspired oxygen (FiO2) higher than 40% or 5 liters/min nasally
c. Ventilator support for 10 hours per day or greater (i.e., daytime use), or the use of mouthpiece ventilation
d. Both sophisticated alarms and accompanying internal battery (high-dependency patient)
e. Persistence of hypercapnia with PaCO2 > 52 mm Hg despite use of E0471 BPAP therapy

We appreciate your attention to this matter. To improve the health and well-being of our patients, we must increase access to long-term non-invasive ventilation among patients with stable hypercapnic COPD.

Robert L. Owens, MD
Chair, Sleep and Respiratory Neurobiology Assembly
American Thoracic Society

References:

1) Kohnlein T, Windisch W, Kohler D, et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicenter, randomized, controlled clinical trial. Lancet Respir Med. 2014;2(9): 698-705.
2) Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
3) Macrea M, Oczkowski S, Rochwerg B, et al; on behalf of the American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease. An official American Thoracic Society Clinical Practice Guideline: executive summary. Am J Respir Crit Care Med. 2020;202(4):e74-e87.12.
4) Ergan B, Oczkowski S, Rochwerg B, et al. European Respiratory Society guidelines on long-term home non-invasive ventilation for management of COPD. Eur Respir J. 2019;54(3):1901003.
5) Wilson ME, Dobler CC, Morrow AS, et al. Association of home noninvasive positive pressure ventilation with clinical outcomes in chronic obstructive pulmonary disease: a systematic review and meta-analysis. JAMA. 2020;323(5):455-465.
6) Frazier WD, Murphy R, van Eijndhoven E. Non-invasive ventilation at home improves survival and decreases healthcare utilization in Medicare beneficiaries with chronic obstructive pulmonary disease with chronic respiratory failure. Respir Med. 2021;177:106291.
7) McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12. PMID: 19213769.
8) Hill NS, Criner GJ, Branson RD, Celli BR, MacIntyre NR, Sergew A; ONMAP Technical Expert Panel. Optimal NIV Medicare Access Promotion: Patients With COPD: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021 Nov;160(5):e389-e397. doi: 10.1016/j.chest.2021.06.082. Epub 2021 Jul 30. PMID: 34339684
9) Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive Summary: Optimal NIV Medicare Access Promotion: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest. 2021 Nov;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074. Epub 2021 Jul 30. PMID: 34339685
10) Kim C, Marchetti N, Criner GJ. Nocturnal hypercapnia and acidosis despite normoxemia in patients hospitalized for exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2016;193:A5190.
11) Burnett GW, Stannard B, Wax DB, et al. Self-reported Race/Ethnicity and Intraoperative Occult Hypoxemia: A Retrospective Cohort Study. Anesthesiology. May 1 2022;136(5):688-696. doi:10.1097/ALN.0000000000004153
12) Jamali H, Castillo LT, Morgan CC, et al. Racial Disparity in Oxygen Saturation Measurements by Pulse Oximetry: Evidence and Implications. Ann Am Thorac Soc. Dec 2022;19(12):1951-1964. doi:10.1513/AnnalsATS.202203-270CME

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I appreciate this important matter being reconsidered. The now long-standing decision guidelines for coverage have not served our patients well, and in particular create inequities to care due to non-clinical or demographic issues. I support the recommended changes by the ONMAP Technical Expert Panel published in CHEST 2021 for patients with COPD. In particular this includes: 1) removal of overnight oximetry as a qualification for NIV 2) ability to prescribe NIV with back-up rate capabilities. I further would encourage that the coverage criteria be re-examined to provide a way to best-evidence therapy for patients with chronic respiratory failure due to the other conditions (specified by the TEP in their publications) including restrictive lung disease or hypoventilation syndromes.

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October 11, 2024

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Submitted via: Medicare Coverage Data Submit Public Comments

Re: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD

Dear Ms. Jensen,

Thank you for the opportunity to submit comments on the National Coverage Analysis (NCA) for Durable Medical Equipment Reference List (280.1) to include Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD. As one of the organizations that submitted the formal request to amend §280.1 of the National Coverage Determinations (NCD) Manual, (Pub. 100-03, Part 4, Chapter 1) regarding coverage of positive and negative pressure ventilators as part of the Durable Medical Equipment Reference List, we appreciate the agency opening the review of both positive and negative pressure ventilators for the treatment of chronic respiratory failure (CRF) consequent to COPD as an equipment category that is coverable under the DME benefit.

The American Association for Respiratory Care (AARC) is a national professional organization with a membership of 44,000 respiratory therapists who specialize in providing pulmonary diagnostics and treatment for patients with chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. Respiratory therapists also provide care for patients with pneumonia, lung trauma and other respiratory related diagnosis such as those associated with viral and bacterial infections. Through our work we support more than 170,000 practicing respiratory therapists across the country.

AARC thanks the agency for adopting aspects of the Optimal NIV Medicare Access Promotion (ONMAP) Technical Expert Panel (TEP) Report which is a comprehensive review of the current coverage guidelines for noninvasive ventilation (NIV) in patients with Chronic Obstructive Pulmonary Disease (COPD). The goal is to enhance access to noninvasive ventilators for patients with chronic respiratory failure due to COPD and other conditions, ensuring Medicare beneficiaries receive optimal care. This reconsideration is particularly important in the context of ensuring equitable access to respiratory care by respiratory therapists for all populations, addressing both clinical needs and health disparities.

We recognize that CMS is seeking scientific evidence, specifically any peer-reviewed literature, that describes the role of BPAP or HMVs in the home management of chronic respiratory failure in patients with COPD. The agency is also interested in understanding the relationship that health disparities and health equity have on the access to care for COPD patient. AARC would like to point out that there is no new scientific evidence on the role of BPAP or HMVs in the home management of COPD and thus will focus our recommendations on the aspects of health disparities and health equity.

The formal reconsideration request submitted by the Optimal Noninvasive Ventilation Medicare Access Promotion (ONMAP) Technical Expert Panel (TEP) seeks to address and revise §280.1 of the National Coverage Determinations (NCD) Manual related to positive and negative pressure ventilators in the Durable Medical Equipment (DME) Reference List.

The request outlines issues with the existing coverage policies and proposes comprehensive changes to ensure appropriate care and device selection for patients requiring noninvasive ventilation. Below is an overview of the key elements discussed in the request:

Optimal NIV Medicare Access Promotion (ONMAP)" Technical Expert Panel (TEP) Report

Key Findings and Recommendations:

1. Background: The request was initially submitted on March 25, 2016, for ventilators and BPAP used in the treatment of Chronic Obstructive Pulmonary Disease (COPD).

2. TEP Members: The Technical Expert Panel (TEP) consisted of representatives from major respiratory and sleep-related societies: American Association for Respiratory Care, American College of Chest Physicians, American Academy of Sleep Medicine, and American Thoracic Society.

3. Segmented Patient Populations: The TEP identified several patient populations that benefit from Noninvasive Positive Pressure Ventilation (NIPPV): Chronic Obstructive Pulmonary Disease, Thoracic Restrictive Disease, Hypoventilation Syndromes, Central Sleep Apnea, and Obstructive Sleep Apnea.

4. Barriers in Current Coverage:

• Current guidelines focus primarily on oxygenation (O2 saturation) rather than ventilation. This approach fails to recognize the primary importance of managing hypercapnia (elevated CO2 levels) in COPD patients.
• The nocturnal oximetry test requirement (to show oxygen saturation below 88%) excludes many patients from receiving NIV, especially since supplemental oxygen can mask or worsen the underlying CO2 retention.

5. Proposed Changes to CMS Coverage Policies:

• Eliminate the requirement for nocturnal oximetry tests in determining eligibility for NIV. The focus should be on arterial blood gas (ABG) results showing PaCO2 = 52 mm Hg.
• Allow initiation of therapy with BPAP devices with backup rate capability rather than starting with BPAP without backup, which may be insufficient for many patients.
• Introduce a second 90-day adherence trial period to allow patients additional time to demonstrate adherence and clinical improvement.
• Clear guidelines should be established for when HMVs are required based on specific clinical needs, such as higher oxygen requirements, persistent hypercapnia despite BPAP therapy, and the need for advanced alarms or backup power.

6. Need for Clinical Support:

• Successful implementation of NIV at home requires ongoing clinical support, often from respiratory therapists. The report highlights the need for face-to-face home visits to ensure that the devices are correctly set-up, adjusted, and the patients are adhering to therapy.
• Despite the clear benefit of such support, current CMS reimbursement policies do not cover the services of respiratory therapists, which leads to poorer patient outcomes and higher healthcare costs.

7. Health Disparities and Specific Issues:

• Pulse Oximetry Oxygen Saturation Accuracy: One of the health disparities discussed is that oxygen saturation measurements (with pulse oximetry) are less accurate in people of color. This has been a well-documented issue where darker skin tones can lead to less accurate readings, which can result in underestimating hypoxemia (low oxygen levels). In Black patients, SpO2 often overestimates SaO2, potentially denying patients from qualifying for home oxygen therapy which can improve quality and prolong life. This presents a challenge in managing conditions like COPD or sleep apnea in diverse populations.
• Need for Sleep Studies: The reconsideration also addresses the importance of sleep studies (polysomnography) to properly diagnose and manage sleep apnea in patients. Sleep studies are essential for differentiating between obstructive and central sleep apnea, which require different treatment modalities. The reconsideration seeks to improve the coverage and accessibility of sleep studies, especially for vulnerable populations.

8. Technological Advances and Evidence:

• The use of volume-assured pressure support and other newer ventilation modes blur the line between BPAPs and HMVs, creating confusion around device classification and reimbursement.
• Randomized controlled trials have shown that NIV with a backup rate significantly reduces mortality and hospitalizations in patients with chronic hypercapnic respiratory failure from COPD.
• The panel emphasizes the importance of high inspiratory pressure settings and backup rates for optimal long-term management of COPD, which should be covered under CMS guidelines.
• Device Selection:
  The TEP emphasizes that device selection should be based on the patient’s specific condition (COPD, thoracic restrictive disease, etc.) and supported by clinical evidence. BPAP and CPAP devices should be covered based on clinical necessity, not broad or restrictive criteria.

The goal is to enhance access to noninvasive ventilators for patients with chronic respiratory failure due to COPD and other conditions, ensuring Medicare beneficiaries receive optimal care. These changes will help ensure that the right device is provided to the right patient at the right time. The proposed adjustments will reduce barriers to care, improve patient outcomes, and promote equity in access to life-saving respiratory therapies for Medicare beneficiaries with chronic respiratory conditions such as COPD.

Thank you for the opportunity to provide our comments. If the agency requires additional information or would like to meet to discuss our comments, please contact please contact Miriam O’Day, Senior Vice President of Government Affairs, AARC (Miriam.oday@aarc.org.). We look forward to working with the agency on these critical issues.

Sincerely,

The AARC President

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COMMENT IN RESPONSE TO CMS’ REQUEST FOR PUBLIC COMMENT REGARDING RECONSIDERATION AND REVISION OF § 280.1 OF THE NATIONAL COVERAGE DETERMINATIONS MANUAL, DURABLE MEDICAL EQUIPMENT REFERENCE LIST: VENTILATORS, (PUB. 100-03, PART 4, CHAPTER 1)

Sleep Management, L.L.C., d/b/a VieMed, a national leader in respiratory care and technology-enabled home medical equipment services (“VieMed”), and Dr. William Frazier, M.D., VieMed’s Chief Medical Officer, [1] hereby submit this formal comment and recommendations (this “Comment”) regarding the reconsideration and revision of NCD 280.1 as it relates to noninvasive positive pressure ventilation (“NIPPV”) in the home for the treatment of chronic respiratory failure (“CRF”) consequent to chronic obstructive pulmonary disease (“COPD”). [2] Per NCD 280.1, Medicare covers home mechanical ventilators (“HMVs,” HCPCS E0466) [3] for the treatment of CRF consequent to COPD (“COPD-CRF”), thoracic restrictive diseases, and neuromuscular diseases.

A 2021 technical expert panel (“TEP”) report [4] made recommendations for an HMV NCD reconsideration for these disorders and for hypoventilation syndromes, obstructive sleep apnea (“OSA”), and central sleep apnea (“CSA”) (the “TEP Reconsideration Request”). In response to the TEP Reconsideration Request, on September 11, 2024, the Centers for Medicare & Medicaid Services’ (“CMS”) requested public comments “that include scientific evidence, specifically any peer-reviewed literature, that describes the role of BPAPs [5] or HMVs in the home management of chronic respiratory failure in patients with COPD [, and] aspects of health disparities and health equity that should be considered in the review.” [6]

Dr. Frazier and VieMed have carefully reviewed the TEP request and agree with several of its recommendations. However, Dr. Frazier and VieMed believe recent studies, including several published since the 2021 TEP report, concerning the use of HMVs to treat COPD-CRF suggest that updated recommendations are appropriate. Please note that this Comment is limited to revisions of NCD 280.1 as it relates to the treatment of COPD-CRF with NIPPV.

VieMed’s NCD Recommendations for NIPPV Coverage in Patients with CRF-COPD

With respect to the optimal treatment of COPD-CRF with NIPPV, new research findings, updated formal practice guidelines, and current consensus expert opinion have converged. This consensus intractably conflicts with existing Medicare coverage requirements. Reconciling the science and the realities of clinical practice with Medicare coverage standards necessitates CMS’s revision of NCD 280.1 to clarify and narrow HMV coverage for patients with COPD-CRF. The research underpinning each of the recommended changes is set forth below.

1. The NCD should limit NIPPV coverage to patients with hypercapnic COPD-CRF, defined as a PaCO2 >45 mm Hg, with appropriate pH compensation determined by a treating healthcare provider to establish chronicity, as measured by an arterial blood gas.

Current data suggests that the benefits of NIPPV in COPD-CRF patients are limited to those who have a confirmed diagnosis of chronic hypercapnia. Hypercapnia is defined as an elevation of PaCO2 > 45 mm Hg in the bloodstream. [7] There is no data showing the precise level of PaCO2 elevation necessary to achieve these demonstrable benefits from NIPPV treatment for COPD-CRF patients.

Appropriate pH compensation in mild to moderate chronic hypercapnia (PaCO2 between 45- and 60-mmHg) exists at a pH at or slightly below the lower limit of normal (e.g., pH 7.33 to 7.35). In severe chronic hypercapnia (PaCO2 between 61- and 100-mmHg), appropriate pH compensation exists at much lower values (e.g. pH 7.15 to 7.25). Figure 5 in “Response to Graded Degrees of Chronic Hypercapnia” shows the 95% significance bands for plasma pH and H+ and HCO3- concentrations in chronic hypercapnia, which demonstrates the variability in pH values for a given value of PaCO2. [8] Importantly, these pH value ranges are general principles and may be influenced by the presence of mixed and complex acid-base disturbances. Given the wide range of pH values that can be seen in compensated hypercapnic COPD-CRF cases, the NCD should not require an exact maximum or minimum pH to qualify for NIPPV. Instead, the treating health care provider who is prescribing NIPPV is in the best position to determine what level of pH compensation proves hypercapnia is chronic for each individual COPD-CRF patient, given their awareness of the influences of numerous other medical conditions that may affect the proper pH compensation required for a complex condition such as COPD-CRF.

Medicare claims data analysis, published in 2022, shows that any level of chronic hypercapnia was associated with decreased mortality and hospitalization risks when NIPPV was used to treat COPD-CRF. [9] This is consistent with a 2020 meta-analysis of NIPPV use in hypercapnic COPD-CRF patients, published in JAMA, which similarly concluded that:

At the time of the 2021 TEP report, almost all the published prospective studies of NIPPV use in COPD-CRF patients limited enrollment to those with PaCO2 levels greater than or equal to 52 mm Hg, leading some experts to suggest that NIPPV should be limited to such patients. [11] However, there is no published data showing that patients with a PaCO2 between 45 and 51 mm Hg fail to benefit from NIPPV use. That these older studies included only individuals with PaCO2 > 51 mm Hg appears to be merely an experimental artifact and cannot be used to conclude that only this group of hypercapnic COPD-CRF patients benefit from NIPPV.

The current best and statistically relevant evidence suggests any level of chronic hypercapnia above 45 mm Hg is sufficient to predict clinical benefits of NIPPV for patients with COPD-CRF. Simply put, any level of hypercapnia is enough. If this qualifying metric—PaCO2 >45 mm Hg with appropriate pH compensation—had been in place from 2016-2020, NIPPV use would have decreased by 46%, the percentage of NIPPV treated patients who had non-hypercapnic COPD-CRF, resulting in substantial savings to Medicare. [12]

2. The NCD should state that initiation of NIPPV coverage is appropriate at any time following confirmation of a qualifying diagnosis, including immediately following an acute exacerbation of hypercapnic COPD-CRF or during a hospitalization.

Some experts recommend a two to four week waiting period after an acute exacerbation of hypercapnic COPD-CRF before initiating NIPPV. [13] This opinion is based on outdated studies undertaken between 2008 and 2018, which showed better outcomes in the “delayed start” cohort. [14, 15, 16, 17, 18] Even then, not all the data supported a “delayed start” strategy. For example, a 2017 prospective study showed that hypercapnic COPD-CRF patients delaying NIPPV initiation for two to four weeks had no decrease in mortality compared to those given only home oxygen. [19]

Three more recent studies of Medicare claims data, published between 2020 and 2022, show that the earlier NIPPV begins after a diagnosis of hypercapnic COPD-CRF is made, the greater the clinical benefits and cost savings. [20, 21, 22] These three studies show that if NIPPV treatment is delayed by more than 30 to 60 days, the reduction in mortality and cost savings benefits—though not the reduction in hospitalizations—disappear. It is increasingly clear that when initiating HMV for hypercapnic COPD-CRF patients, the sooner treatment begins, the better.

3. The NCD should state that the device initially used to provide NIPPV in hypercapnic COPD-CRF should be chosen by the healthcare provider and the patient, and that there is no “tried and failed” step therapy requirement.

In the U.S. Medicare population, NIPPV for COPD-CRF is overwhelmingly provided by HMVs, not by BPAPs or by time-cycled BPAPs termed “respiratory assist devices” (“RADs”, HCPCS E0471). Analysis of the Medicare fee-for-service claims data showed that from 2016 to 2020, 7,937 COPD-CRF Medicare beneficiaries were prescribed NIPPV at home. Of these patients, 7,329 (92%) received HMVs, 512 (7%) received BPAPs and just 96 patients (1%) were prescribed RADs. [23] The overwhelming adoption of HMVs by physicians who prescribe NIPPV for hypercapnic COPD-CRF establishes this device as the standard of care for treating these high-risk patients.

The significant differences in HMVs and BPAPs/RADs likely explain the overwhelming preference U.S. physicians have for HMVs. The notable differences between HMVs and BPAPs/RADs include FDA classifications, manufacturing specifications regarding turbine power, and published clinical outcomes.

A. FDA Classification

The FDA classifies HMVs as life-sustaining devices. As such, they are required to have backup batteries and alarms to signal device disconnection. These can be critical features for vulnerable patients’ safety since HMVs can operate during power outages and notify patients and caregivers if they are unintentionally disconnected. The same is not true for BPAPs/RADs, which do not have battery backup or alarms, and they are not classified as “life sustaining devices.”

Another example of the differences in the way the FDA views HMVs and BPAPs/RADs is reflected in an April 2024 consent decree between the FDA and Philips Respironics, which forbids Philips from selling BPAPs/RADs in the U.S. but allows them to continue selling HMVs, since HMVs are classified as “medically necessary devices” while BPAPs/RADs are not. [24]

B. Manufacturing Specifications Regarding Turbine Power

HMVs are manufactured with powerful turbines to provide the high peak airflow and maximal pressures that are the heart of mechanical ventilation. BPAPs/RADs deliver a maximum inspiratory pressure of approximately 25 cm/H20 with a peak airflow of < 90 liters per minute. HMVs deliver a maximum inspiratory pressure of 50cm/H20 with a peak airflow of >180 liters per minute, meaning HMVs are approximately twice as powerful as BPAPs/ RADs. The more powerful turbines allow HMVs to reliably provide the flow rates and maximal pressures necessary to keep up with the rapidly changing conditions of a COPD-CRF patient’s lung mechanics and mask leaks.

Rapid changes in delivered airflow ensures the correct tidal volume is delivered the appropriate number of times per minute to optimize ventilation, while minimizing lung injury. These are the goals of mechanical ventilator support. Because BPAPs/RADs generate much lower peak airflows and maximal pressures, they may not compensate quickly enough for the changing patient conditions and respiratory needs detailed above. These differences in performance likely explain the different outcomes reported between BPAPs/RADs and HMVs when used to treat COPD-CRF.

C. Published Clinical Outcomes

Research published during the past ten years confirms that higher pressures and higher flow rates are essential to optimally treat hypercapnic COPD-CRF patients. This approach is called high intensity ventilation. It was only after this concept was introduced in 2014 that the benefits of NIPPV for hypercapnic COPD-CRF became apparent. [25] The importance of using HMVs to provide NIPPV was shown in three recent papers demonstrating large, statistically significant reductions in mortality, hospital admissions, and overall healthcare spending in Medicare beneficiaries with hypercapnic COPD-CRF who were treated with HMVs compared to those who were not. [26] Conversely, a randomized trial done in the U.K. showed no improvement in mortality when hypercapnic COPD-CRF patients were treated with BPAPs/RADs. [27] Interestingly, a more recent paper from the U.K. using HMVs in hypercapnic COPD-CRF reported a significant mortality reduction. [28]

While no head-to-head studies directly comparing HMVs to BPAPs/RADs for the treatment of COPD-CRF exist, the studies referenced herein consistently report significant reductions in mortality and hospitalizations when using HMVs. No such data exists for BPAP/RAD use in a Medicare COPD-CRF population. It is the opinion of Dr. Frazier that the use of BPAPs/RADs in hypercapnic COPD-CRF should be confined to clinical trials until they have been shown to be as safe and effective as HMVs.

Dr. Frazier is also not aware of any published data supporting “tried and failed step therapy” wherein patients must first fail a treatment trial with BPAPs/RADs before being approved for HMV. Moreover, there are no generally accepted, objective, clinical criteria for determining what constitutes a BPAP/RAD failure. The imposition of a “tried and failed step therapy” coverage criteria forces COPD-CRF patients to utilize BPAP/RAD devices that likely cannot compensate quickly or effectively enough for their changing conditions and respiratory needs. Due to the nature of COPD-CFR, an artificial requirement of “tried and failed step therapy” will likely jeopardize patient health, reduce a COPD-CRF patient’s quality of life, and increase the risk of premature death.

The six criteria the 2021 TEP Reconsideration Request suggest the NCD should require before COPD-CRF patients are allowed to switch from BPAPs/RADs to HMVs [29] are not supported by published outcomes data. These criteria are subjective, unnecessary, and unduly burdensome for patients and providers alike. Recent data from studies conducted in 2020 to 2022 shows mortality reductions occur only if HMV is begun within the first 30-60 days following a hypercapnic COPD-CRF diagnosis. [30] HMV coverage should not be conditioned on patients failing with BPAPs/RADs when that therapy has not been shown to be as effective as HMV. A policy requiring the delay of HMV initiation until a patient fails on BPAPs/RADs is without scientific or medical basis and exposes patients to potential harm and providers to potential malpractice liability.

4. The NCD should not include a minimum use threshold for continued NIPPV coverage.

The 2021 TEP recommendation that a minimum average use of four hours per day should be required for continued NIPPV coverage is arbitrary and should not be included in the NCD. As the TEP Reconsideration Request documents, NIPPV use in clinical trials averages <4 hours/day in at least 30% of patients. [31] It is likely the “real world” usage is even less. Nonetheless, the published “real world” data detailed herein, which does not report hours of use, shows robust clinical improvements when HMVs are used to treat hypercapnic COPD-CRF. [32]

Given the high mortality and morbidity seen in hypercapnic COPD-CRF and the lack of data on how much NIPPV use is necessary to reduce these risks, the most prudent course is to continue NIPPV therapy in those patients who wish to do so regardless of their pattern of use, while simultaneously mandating interventions to maximize compliance with therapy.

5. The NCD should require durable medical equipment suppliers to provide “frequent and substantial servicing” by respiratory therapists in the home for NIPPV patients.

Chronic respiratory failure is a life-threatening disorder and its treatment with HMV is necessarily complex. To achieve optimal clinical outcomes, a close partnership between patients and in-home based, easily accessible respiratory professionals well versed in HMV therapy, is essential. As stated in a recent technical expert report on HMV:

While all providers recommend regular use of HMV in COPD-CRF patients, no reliable data exists validating a minimal use criterion below which the benefits disappear. Nonetheless, it stands to reason that increased compliance with HMV will increase the probability of improving clinical outcomes.

Due to the challenges of maximizing compliance with HMV, the NCD should require “frequent and substantial servicing” including in-home and virtual visits by respiratory therapists as often as needed and at least monthly. These visits should include ongoing training on appropriate HMV use and an objective measurement of HMV compliance with a detailed plan on increasing compliance if needed.

6. The NCD should not require requalification of hypercapnic COPD-CRF patients for NIPPV.

COPD has no cure and is often progressive. Once a patient develops hypercapnic COPD-CRF and qualifies for NIPPV, there is little chance that they will improve enough to no longer need this therapy. Demanding that patients repeatedly prove they are sick enough to warrant NIPPV by requiring repeated PaCO2 measurements or other requalification metrics is a waste of health care resources and serves only as an impediment to patients receiving this life prolonging and cost-effective therapy.

7. The NCD should not require overnight oximetry or a sleep study for approval of NIPPV to treat hypercapnic COPD-CRF.

Overnight oximetry showing hypoxia should not be necessary for COPD-CRF patients to qualify for NIPPV. Additionally, a sleep study should not be necessary prior to beginning NIPPV. These tests only add to health care costs and no clinical rationale or published data support their use in this setting.

8. The NCD should not implement requirements that stand to worsen health equity among Medicare beneficiaries.

African Americans and economically disadvantaged Americans are much more likely to have hypercapnic COPD-CRF than other groups of Medicare beneficiaries (p<.0001). [34] Moreover, African Americans with COPD have “significantly worse respiratory symptoms and quality of life and have higher risks of severe exacerbations” compared to white Americans with COPD. [35] These populations also disproportionately struggle with securing access to care and sustaining treatment. They will be disproportionately affected if a new NCD limits access to NIPPV.

If a new NCD mandates a “tried and failed” coverage requirement for BPAP/RAD use prior to HMV use, the increased mortality and hospitalization risks associated with BPAPs/RADs will be disproportionately borne by these vulnerable populations. These populations will be similarly impacted if the new NCD requires annual or semi-annual requalification or extensive pre-coverage testing. Given the high risk to patients’ health posed by denial of an HMV, utilization management tactics such as testing and re-evaluation must be supported by overwhelming scientific and clinical evidence. That is simply not the case here.

Rulemaking which mandates disadvantaged populations navigate scientifically unsupported and clinically unnecessary medical procedures and testing to access and maintain life-sustaining NIPPV coverage creates unnecessary and harmful barriers to needed healthcare and will disproportionally affect these vulnerable populations. To the extent such a rule results in denials of coverage that disproportionately affect a specific racial or ethnic group it would raise serious civil rights concerns. [36]

Such restrictions are also unnecessary on costs grounds. As noted earlier, costs can be effectively contained without harming patients by limiting NCD coverage to patients with a PaCO2 >45 mm Hg who have appropriate pH compensation. As noted previously, had this metric been in place from 2016-2020, NIPPV use would have decreased by 46% without harming appropriate patients’ access to life-sustaining care and, therefore, resulting in substantial savings to Medicare. [37]

Summary and Conclusion

In summary, a revised, updated NCD for NIPPV use to treat COPD-CRF should:

1. Indicate NIPPV coverage for hypercapnic COPD-CRF patients who have an elevation of PaCO2 above the upper limit of normal.
2. State that NIPPV should be initiated as soon as possible following the diagnosis of hypercapnic COPD-CRF.
3. State that the initial device chosen to deliver NIPPV may be an HMV, a BPAP, or a RAD, that the choice of device is at the discretion of the prescribing healthcare provider, and not require patients to try and fail BPAP/RAD therapy before coverage is provided for an HMV.
4. Require frequent and substantial servicing of NIPPV and require all NIPPV service providers to adhere to detailed clinical standards aimed at optimizing device utilization, which are set forth in the NCD.
5. Not require an arbitrary “hours of use” metric for continued NIPPV coverage. While adherence to NIPPV is important to optimize outcomes, the minimal usage necessary to achieve this is unknown. Any use is enough use for the patient to keep the equipment.
6. Not require patients to requalify for NIPPV. Hypercapnic COPD-CRF is a persistent disease with no known cure, so requalification is an unnecessary burden and wastes health care resources.
7. Not require overnight oximetry or sleep tests to qualify hypercapnic COPD-CRF patients for NIPPV.
8. Not implement requirements that stand to worsen health equity among Medicare beneficiaries. Hypercapnic COPD-CRF is more common in African Americans and in economically disadvantaged people. Any NCD changes that limit access to NIPPV will disproportionately affect these groups.

With this Comment, VieMed and Dr. Frazier recommend that CMS revise NCD 280.1, in accordance with the above recommendations, to clarify and narrow Medicare coverage of HMVs for COPD-CRF patients. When such patients have objectively confirmed chronic hypercapnia, their prognoses can be greatly improved by life-sustaining HMV therapy.

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Endnotes:

1 Dr. Frazier is a pulmonologist with over thirty years of clinical experience treating COPD-CRF. He is board certified in Pulmonary Medicine, Sleep Disorders Medicine, and Critical Care Medicine. His work as the Chief Medical Officer of VieMed has afforded him the unique opportunity to closely observe thousands of COPD-CRF patients using NIPPV. Dr. Frazier leads VieMed’s clinical research program, which has published three peer-reviewed publications since 2021 reporting outcomes using HMVs to provide NIPPV to Medicare patients with COPD-CRF.

2 DEP’T OF HEALTH AND HUMAN SERVS., CTRS. FOR MEDICARE & MEDICAID SERVS., Medicare National Coverage Determinations Manual; Durable Medical Equipment Reference List, Medicare Coverage Database, Publication 100-3 Section 280.1 (May 5, 2005) https://www.cms.gov/regulations-and-guidance/guidance/manuals/internet-only-manuals-ioms-items/cms014961; (hereinafter, CMS, NCD 280.1).

3 Contextually, references herein to “HMV” may refer either to the process of “home mechanical ventilation” or the devices known as “home mechanical ventilators.”

4 Peter C. Gay and Robert L. Owens, Formal Request for Reconsideration of § 280.1, Durable Medical Equipment Reference List: Ventilators, Pub 100-03, Part 4, Chapter 1 (September 9, 2021) chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cms.gov/files/document/id315.pdf.

5 In this context, and throughout this Comment, the term “BPAPs” refers to bi-level positive airway pressure devices (HCPCS E0470).

6 DEP’T OF HEALTH AND HUMAN SERVS., CTRS. FOR MEDICARE & MEDICAID SERVS., National Coverage Analysis (NCA), Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD, CAG-00465N (Sept. 11, 2024) https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=315.

7 Amilkar Almaza-Hurtado et al., Hypercapnia from Physiology to Practice, Int. J. Clin. Pract. (2022) https://doi.org/10.1155/2022/2635616.

8 Schwartz W.B., Brackett N.C., Jr., Cohen J.J., The response of extracellular hydrogen ion concentration to graded degrees of chronic hypercapnia: the physiologic limits of the defense of pH, J Clin Invest. (1965) https://dm5migu4zj3pb.cloudfront.net/manuscripts/105000/105143/JCI65105143.pdf.

9 William D. Frazier et al., Early Initiation of non-invasive ventilation at home improves survival and reduces healthcare costs in COPD patients with chronic hypercapnic respiratory failure: A retrospective cohort study Resp Med (2022) https://doi.org/10.1016/j.rmed.2022.106920.

10 Michael E. Wilson et al., Association of Home Noninvasive Positive Pressure Ventilation with Clinical Outcomes in Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis, 323 JAMA 455, 461 (2020).

11 Nicholas S. Hill et al., Optimal Noninvasive Medicare Access Promotion: Patients with COPD: Technical Expert Panel Report from the American College of Chest Physicians, the Association for Respiratory Care, the American Academy of Sleep Medicine, American Thoracic Society, 160 CHEST J. E389 (2021).

12 Frazier et al., supra note 9.

13 Madalina Macrea et al., Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease: An Official American Thoracic Society Clinical Practice Guideline, 202 Am. J. of Respiratory & Critical Care Med. 74, 2183 (2020).

14 Michael Dreher et al., High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: A randomised crossover trial, 65 Thorax 303 (2010).

15 Marieke L. Duiverman et al., Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: A randomized controlled trial, 12 Respir. Res. 112 (2011).

16 Marieke L. Duiverman et al., Nocturnal non-invasive ventilation in addition to rehabilitation in hypercapnic patients with COPD, 63 Thorax 1052 (2008).

17 Marieke L. Duiverman et al., Impact of High-Intensity-NIV on the heart in stable COPD: a randomised cross-over pilot study, 18 Respir. Res. 76 (2017).

18 V. Dura et al., Chronic respiratory failure in patients with chronic obstructive pulmonary disease under home noninvasive ventilation: Real-life study, 24 Pulmonology 280 (2018).

19 Patrick B. Murphy et al., Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial, 317 JAMA 2177, 2181-84 (2017).

20 William D. Frazier et al., Non-invasive Ventilation at Home Improves Survival and Decreases Healthcare Utilization in Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease with Chronic Respiratory Failure, 177 Respiratory Med. 106291, 106293-95 (2020).

21 William D. Frazier et al., Non-invasive Ventilation at Home Reduces Mortality in COPD with CRF, 27 Am. J. Managed Care e308, e313 (2021).

22 Frazier et al., supra note 9.

23 Id.

24 U.S. Food and Drug Administration, Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines (April 9, 2024) https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-philips-respironics-following-recall-certain-sleep.

25 Kohnlein et al., Non-invasive Positive Pressure Ventilation for the Treatment of Severe Stable Chronic Obstructive Pulmonary Disease: A Prospective, Multicentre, Randomised, Controlled Clinical Trial, 2 Lancet Respiratory Med. J 698 (2014).

26 Frazier et al., supra note 9; Frazier et al., supra note 20; Frazier et al., supra note 21.

27 Murphy et al., supra note 19.

28 Grace McDowell, et al., Assistive Technologies for Home NIV in Patients with COPD: Feasibility and Positive Experience with Remote-Monitoring and Volume Assured Auto-EPAP NIV Mode, 8 BMJ Open Respiratory Research 000828 (2021).

29 Gay & Owens, supra note 4 at 13-14 (The six criteria identified by TEP are: (1) Higher inspiratory pressures than those deliverable by E0471; (2) FiO2 >40% or 5 L/min nasally; (3) Ventilator support for =10 h/day (i.e., daytime use); (4) Both sophisticated alarms and accompanying internal battery (high-dependency patient); (5) Mouthpiece ventilation during the day; (6) Persistence of hypercapnia with PaCO 2 =52 mm Hg despite adequate adherence to BPAP therapy).

30 Frazier et al., supra note 9; Frazier et al., supra note 20; Frazier et al., supra note 21.

31 Macrea, supra note 13.

32 Frazier et al., supra note 9; Frazier et al., supra note 20; Frazier et al., supra note 21.

33 Hill et al., supra note 11, at E395-96.

34 Frazier et al., supra note 9.

35 Chinedu O. Ejike et al., Contribution of Individual and Neighborhood Factors to Racial Disparities in Respiratory Outcomes, Am. J Respir. Crit. Care Med. (2021) https://doi.org/10.1164/rccm.202002-0253OC.

36 42 U.S.C. § 2000d.

37 Frazier et al., supra note 9.

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A motto of the American Lung Association is, “When you can’t breathe, nothing else matters.” People who have severe COPD struggle to breathe. The present Medicare coverage rules puts unnecessary roadblocks in their way of accessing the treatment that they immediately need; that being noninvasive ventilation with a timed backup rate. Also, the coverage rule of requiring oxygen monitoring with specific results during a sleep study is another roadblock that should be eliminated; it is not necessary & also wastes Medicare money. Please follow the evidence based recommendations of the physician experts from the American College of Chest Physicians. This will save lives & reduce suffering for many Medicare beneficiaries.

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I am writing in response to the CMS request for public comments regarding the reconsideration of National Coverage Determination (NCD) 280.1, specifically focusing on the use of noninvasive positive pressure ventilation (NIPPV) in the home for patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD).

For the degree of COPD in American population ( and the world ) , the number of good quality , controlled, studies, showing all options of support, and degree of successful ( and meaningful ) help with COPD & Hypercapnia, is clearly disappointingly small.
The few, but often cited (see below ) studies show support for our current complex & expensive NIV home ventilators. Unfortunately, there are not head-to-head studies , with less complex and costly RAD PAP machines, such as an E0471 device. The cost to tax payers & society can exponentially less ( or inversely, potential coverage expanded by 10x ) if an E0471 device is first considered, and found successful.
In this age of finite CMS / Medicare resources, to rely on a few incomplete and limited NIV/NIPPV/RAD/PAP device studies, to make historic decisions… is alarming. There are no good studies showing, that starting home NIV treatment for COPD, with a less costly and complex RAD E0471 device, allows any harm or loss of health. It is clear however, that starting home NIV COPD support, with the most complex and costly NIV support device ( an E0466 ) , begins a very costly journey for both the member ( in co pays ) & to CMS/Medicare.
Importantly, we should not ignore the recent findings , of a lawsuit filed and won, against NIV DME Vendors, for there mis coding & billing, for the expensive E0466 Home NIV device ( when the settings were clearly in a PAP PS RAD support mode ).
https://www.justice.gov/usao-sdny/pr/us-attorney-announces-255-million-settlement-durable-medical-equipment-supplier
This clearly shows that this is a ripe area for waste , fraud and abuse, by both ordering Providers, and DME vendors, whom Champion the use of the most costly & complex device ( E0461 ) , while rarely providing objective data, that a less complex & costly E0471 device, has failed to help a member with COPD.
To turn back the clock , and allow an E0466 device, for every CMS member with “ COPD”, will immediately escalate & hasten, the bankruptcy of this institution. A new NCD, must include language that promotes( or requires ) the initial trial, or testing, of a less complex/costly E0471 RAD home machine, before automatically granting an E0466 device.

Respectfully submitted

scientific references below:
JAMA Network Study on NIPPV and Outcomes in COPD https://jamanetwork.com/journals/jama/fullarticle/2760390
Respiratory Research Study on NIPPV in Home Settings https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-12-112
European Respiratory Society Guidelines on Long-term NIPPV https://erj.ersjournals.com/content/54/3/1901003

OIG-supported investigation leads to $25.5 million settlement in durable medical equipment case April 17, 2024 WASHINGTON — A durable medical equipment provider agreed on February 15, 2024, to a $25.5 million settlement with the United States to resolve claims that it violated the False Claims Act by fraudulently continuing to bill health care programs, to include Amtrak’s, for the rental of costly non-invasive ventilators when patients no longer needed or used the devices. According to a press release from the U.S. Attorney’s Office, Southern District of New York, Lincare Inc, the provider, agreed to pay a total sum of $25.5 million, of which $24,228,517.96 will be paid to the United States and the remainder will be paid to various states. The settlement also resolved claims that Lincare violated the Anti-Kickback Statute by waiving coinsurance payments to induce certain Medicare and TRICARE beneficiaries to rent its ventilators. Lincare also admitted that it received reimbursement from health care programs for some ventilator rental claims that did not comply with all of those programs’ billing rules and guidance, and that it continued to seek monthly payments when it was aware that patients were not using the devices.
Philips Respironics has agreed to pay more than $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to durable medical equipment (DME) suppliers. The affected programs were Medicare, Medicaid, and TRICARE.
The settlement resolves allegations that Respironics caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment that were false because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers physician prescribing data free of charge that could assist their marketing efforts to physicians.
The lawsuit resolved by this settlement is captioned United States, et al., ex rel. Respiratory Care., LLC v. Respironics, Inc., et al., Case No. 2:19-cv-02913-BHH (D.S.C). The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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Having worked for over 45 years in the field of Respiratory Care, I have setup and managed over 1000 non-invasive ventilators and have seen the vast majority of compliant patients benefit greatly from the benefits provided. As a diagnosis driven modality, requirements need to be clear cut and adhered to by both DMEs and insurers. This should be across the board with all variations of Medicare required to follow. This includes Red, White and Blue AND Medicare Advantage plans.
Chronic respiratory conditions account for inordinately large costs for hospitalizations and unscheduled physician visits, both of which are proven to be reduced by compliant use of NIV in conjunction with proper medication management and early intervention.

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I appreciate that this topic is being considered as a new NCD section, however I feel strongly that other conditions need to be considered for NCD coverage as well that constitute the need for NIPPV usage in the home. There should be clinical coverage guidelines for providers to follow for neuromuscular conditions and thoracic restrictive conditions. Often times, there is a fine line of what diagnosis should be considered as "thoracic restrictive", as many providers can consider obesity hypoventilation syndrome restrictive. There needs to be a list of qualifying covered and or noncovered diagnoses for NIPPV usage in the home. There should be lists of tests and value that are qualifying for NIPPV coverage. There also needs to be clarification on compliant usage for NIPPV, as often times the RAD guidelines intermix for ventilators however, ventilators do not have specific rulesets to follow and this makes it very difficult for providers to be certain if all documentation requirements are met in the case of an audit. There should also be a strong ruleset for the Medicare Advantage plans to follow, as a majority of them are NOT following CMS guidelines, but are following the RAD guidelines when determining vent qualifications. Not having an NCD or LCD's for NIPPV has done a huge disservice to both beneficiaries and providers.

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Often patients have comorbidities. While doing sleep studies, I often saw providers ordering sleep studies in hopes that patients would have sleep apnea as well as their COPD. They were desperately looking to provide support to ventilation at home. They were hoping NCPAP could provide at least "something". The criteria for home ventilation have made it too hard to qualify patients until they are end of life. Earlier NIPPV treatment will reduce hospitalizations, and visits to the ER. Easy access to NIPPV will also have the potential to reduce procedures like tracheostomies to provide invasive ventilation. This will also cut down on readmission with infections from tracheostomies. Lower PCO2 and higher PO2 will provide patients improved cognition and mobility which can also lead to less falls, less broken bones, and decreased hospital admissions. Increasing this area of treatment in the home surely will improve quality of life and reduce hospitalizations.

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Public Comment on CMS Reconsideration of NCD 280.1: Home Noninvasive Positive Pressure Ventilation (NIPPV) for Chronic Respiratory Failure Due to COPD
I am writing in response to the CMS request for public comments regarding the reconsideration of National Coverage Determination (NCD) 280.1, specifically focusing on the use of noninvasive positive pressure ventilation (NIPPV) in the home for patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD).
Clinical Efficacy and Benefits of Home NIPPV
There is substantial evidence supporting the clinical efficacy of long-term home NIPPV in patients with chronic respiratory failure due to COPD. Multiple studies demonstrate that home use of bilevel positive airway pressure (BPAP) and home mechanical ventilators (HMVs) significantly reduces mortality rates, decreases hospital admissions, and delays the need for invasive mechanical ventilation. A meta-analysis including 51,085 patients showed that BPAP reduces mortality (odds ratio 0.66), lowers the frequency of hospital admissions (odds ratio 0.22), and decreases the need for intubation (odds ratio 0.34)?(JAMANetwork). Furthermore, a study examining long-term nocturnal noninvasive ventilation found improvements in health-related quality of life (HRQoL) and reductions in exacerbation rates when added to rehabilitation programs?(BioMed Central).
Improved Outcomes Through Hypercapnia Management
Managing hypercapnia is a key intervention for improving outcomes in COPD patients with chronic respiratory failure. The European Respiratory Society (ERS) provides evidence-based guidelines recommending long-term home noninvasive ventilation (LTH-NIV) to improve outcomes by reducing carbon dioxide levels in these patients. Such management is associated with fewer COPD exacerbations, lower mortality rates, and improved HRQoL?(ERS Journals). These guidelines underscore the importance of using NIPPV in patients with hypercapnic COPD as part of a comprehensive treatment strategy.
Addressing Health Disparities and Health Equity
It is essential to consider health disparities when evaluating access to home NIPPV for patients with COPD. Patients from underserved communities often face challenges in accessing specialized respiratory care, which can exacerbate outcomes in chronic respiratory failure. The availability of home NIPPV can play a crucial role in reducing emergency room visits and hospital readmissions in these populations, improving overall care access and reducing disparities in health outcomes.
Conclusion
Based on the clinical evidence, it is clear that NIPPV, particularly BPAP and HMV, is a critical intervention for managing chronic respiratory failure in COPD patients. Home NIPPV has been shown to improve survival rates, reduce hospitalizations, and enhance the quality of life for these patients. CMS should consider expanding coverage to ensure equitable access to these therapies, particularly for vulnerable populations at greater risk of adverse outcomes.
Please find detailed scientific references below:
JAMA Network Study on NIPPV and Outcomes in COPD https://jamanetwork.com/journals/jama/fullarticle/2760390
Respiratory Research Study on NIPPV in Home Settings https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-12-112
European Respiratory Society Guidelines on Long-term NIPPV https://erj.ersjournals.com/content/54/3/1901003
Thank you for considering this evidence in the development of the new NCD section.

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