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

I am writing to express my concerns regarding the proposed changes to the Bipap and ventilator coverage for COPD patients. The current guidelines appear to prioritize cost-saving measures over patient needs, which is alarming given the critical role these treatments play in the management of COPD.

I strongly urge you to reconsider and delay the approval of these mandates to allow for further evaluation. It is essential to take into account the valuable feedback from the physicians and respiratory therapists who work directly with these patients daily and understand the profound benefits of Non-Invasive Positive Pressure Ventilation (NIPPV). This treatment not only improves the quality of life for COPD patients but also significantly reduces hospital readmissions, ultimately saving costs in the long term.

One of my primary concerns is the potential impact on current NIPPV users. The proposal does not address the issue of grandfathering existing patients who have been on this treatment for years. Should the new mandate apply to them, the required equipment may need to be reclaimed, despite the fact that it has substantially improved their health and well-being. I am deeply concerned about the potential negative health consequences these patients may face if their treatment is discontinued. Additionally, I would appreciate clarification regarding liability should patient outcomes deteriorate due to the discontinuation of essential therapy.

I also have reservations about the proposed mandatory higher pressure settings. These new requirements seem to overlook the individual needs of patients, especially when considering their ability to tolerate these settings. The decision regarding appropriate pressure levels should remain with the treating physician, who is best positioned to assess the patient's condition and adjust settings accordingly.

Moreover, I am unsure why there is a strict 5-hour daily usage requirement without consideration of patient compliance percentage, which is notably more flexible in the case of other conditions, such as Obstructive Sleep Apnea (OSA). It is unrealistic to expect 100% compliance, as there are numerous factors that could prevent consistent use, such as hospitalization, power outages, or temporary respiratory issues.

Another concern is the mandate requiring patients to be reevaluated every 6 months. COPD is a progressive and incurable disease, and re-evaluating patients every 6 months may not only be unnecessary but could also create additional burdens for patients who already struggle with regular visits. These evaluations could lead to the discontinuation of treatment based solely on CO2 levels, without considering the long-term benefits of continued NIPPV use. This could create a harmful cycle for patients and potentially result in higher costs for both the patient and CMS in the future.

Additionally, many patients in our region face challenges in attending appointments, and requiring two visits per year may further complicate their care. The frequency of invasive procedures, such as ABGs, which are not available in all doctors' offices, could also place an undue burden on both patients and healthcare providers. I would suggest considering reimbursement for respiratory therapists to conduct in-home assessments, providing a more convenient and cost-effective alternative for patients.

In conclusion, while I understand that CMS is tasked with balancing patient care and cost control, I believe the current guidelines require further consideration. I respectfully request that you delay the approval of these changes and gather more input from healthcare professionals on the ground who are directly involved in patient care.

Thank you for your attention to this matter. I trust that CMS will prioritize the well-being of patients in the final decision.

Sincerely,
Allison H. Still, RCP
Medical Comfort Systems

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The 6-month re-evaluation and its impact on the patient’s access to continued therapy
– The proposed six-month requirement will make it even harder for chronically ill patients, especially those in rural areas, to access essential ventilation therapy. Many patients already struggle to see their doctors annually, and more frequent visits will create additional barriers to care.

Dear CMS,

I respectfully request that you reconsider the proposed changes to the new policy. As a therapist with five years of experience, I have witnessed firsthand the significant benefits that patients experience from using home Non-Invasive Ventilation (NIV). I strongly urge you to consider grandfathering in patients who are currently using and benefiting from NIV therapy.

Should the new criteria result in the removal of home NIV for patients who do not meet the updated standards, it would be profoundly detrimental to both the patients and the Durable Medical Equipment (DME) suppliers.

Regarding follow-up appointments, many COPD patients face significant challenges with mobility and transportation. Therefore, requiring follow-up appointments every six months after the initial 180-day period, particularly when the patient has already demonstrated compliance with prescribed settings, seems unnecessary. This policy would impose an undue burden on patients, caregivers, and healthcare providers.

I appreciate your attention to these concerns and hope that you will take them into account when finalizing the policy changes.

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April 4, 2025

Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Boulevard Baltimore, MD 21244

Re: Comments on CMS Proposed Decision Memo – Noninvasive Positive Pressure Ventilation (NIPPV)

To Whom It May Concern,

On behalf of SuperCare Health, a leading provider of complex respiratory care and life-sustaining durable medical equipment across California and the Western United States, I am writing to express strong concern regarding the proposed changes to Medicare coverage criteria for Noninvasive Positive Pressure Ventilation (NIPPV) therapies for chronic respiratory failure due to COPD.

As a partner deeply engaged in the care of complex respiratory patients, we believe these changes will place severe and unnecessary burdens on a vulnerable population, disproportionately impacting the very patients CMS aims to protect. Our mission is to ensure access, continuity, and quality of care—and we fear that if implemented as proposed, the new policy will set back years of progress.

How the Proposed Changes Will Harm Patients

The proposed requirements, though well-intentioned, will negatively impact patient access and outcomes in several critical ways:

Clinical and Financial Impact - Delaying or denying access to timely NIV treatment will result in:
-Higher rates of death and hospitalization
-Increased emergency department utilization
-Greater total Medicare expenditures

Peer-reviewed evidence and recent analysis from Dobson/Davanzo/Health Economist (April 2025) underscore that earlier intervention with NIV dramatically improves both health and cost outcomes.

Our Request to CMS and Congress

We urge CMS to reconsider and revise the proposed National Coverage Determination (NCD). Specifically, we request:

SuperCare Health supports CMS’s commitment to high-quality, evidence-based care. However, we believe these changes, as drafted, will result in real harm to patients and must be revised. We welcome continued dialogue and stand ready to provide data, patient stories, and operational insights to support a balanced and patient-centric policy.

Sincerely,

David Fein, MPPA
Sr. Vice President, Strategic Initiatives
SuperCare Health
16017 Valley Blvd, City of Industry, CA. 91744
dfein@supercare.com
562-753-7272

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With a long history of experience in this field, we strongly feel that the proposed NCD for non-invasive ventilation fails to account for the clinical realities and logistical challenges faced by patients with COPD and their care teams.

Most concerning is the absence of grandfathering provisions for patients already receiving RAD or HMV therapy, many of whom lack historical documentation that would comply with the new NCD, but who are clearly benefiting from treatment. In our company, specifically, we have seen patient’s lives completely change over the course of their RAD or HMV therapy. From hospital readmission on a frequent basis to being able to leave their home regularly and staying out of the hospital for an entire year, we have seen the firsthand benefit these devices can provide for COPD patients. Forcing removal of these devices due to documentation gaps, despite a clinician’s judgment, risks severe harm or death.

Additionally, the six-month re-evaluation requirement, paired with the mandate for repeat arterial blood gases, places an unnecessary and impractical burden on patients, particularly those in rural areas, by introducing access barriers, financial strain, and procedural discomfort. Due to an extreme shortage of physicians in rural areas, we talk to patients who have to wait more than 6 months just to get in to see a specialist when they try to make an appointment. This requirement will greatly impact these vulnerable patients.

Finally, the proposed five-hour daily usage threshold diverges from widely accepted adherence standards, threatening continuity of care for patients and creating confusion across the clinical and supplier landscape. To truly serve this population, the NCD must reflect clinical judgment, support continuity of care, and reduce—rather than introduce—barriers to essential, life-sustaining therapy.

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As a practicing pulmonary physician, I strongly oppose the proposed CMS guidelines for BiPAP and ventilator coverage in COPD patients. These guidelines reflect a concerning prioritization of cost-containment over clinical practicality and patient-centered care.

1. Unwarranted Preference for BiPAP over Home Mechanical Ventilation (HMV):
The strong favoring of BiPAP—even at IPAP settings as high as 30 cm H2O—fails to recognize real-world patient tolerance. Many patients will not tolerate these pressures due to discomfort, mask intolerance, or upper airway dynamics. This creates a clinical scenario where patients fail therapy not because they wouldn’t benefit from NIV, but because they are subjected to a poorly tolerated modality first. This risks discouraging patients from continuing or escalating therapy, ultimately leading to poor adherence and worse outcomes.

2. Stepwise Escalation Process Is Unrealistic:
Requiring a documented failure of BiPAP before allowing access to more advanced ventilatory support is clinically inefficient and unrealistic in busy outpatient pulmonary practices. The logistics of initiating, titrating, monitoring, and documenting failure of BiPAP before considering HMV adds significant burden to providers and delays appropriate care for patients with chronic hypercapnic respiratory failure.

3. Unsubstantiated Adherence Requirements:
The increase in minimum adherence from 4 to 5 hours per night has no evidence base. This arbitrary threshold ignores the variability in patient tolerance and clinical benefit. Many patients derive meaningful improvements with less than 5 hours of use per night, and strict cutoffs risk excluding patients who are benefiting from therapy.

4. Burdensome Requirement for Repeat Arterial Blood Gas Testing:
Mandating outpatient arterial blood gas (ABG) testing to assess response to therapy places unnecessary strain on pulmonary clinics and imposes a painful, invasive procedure on patients. ABGs are not routinely used in outpatient settings for this purpose, and safer, less invasive alternatives (such as transcutaneous or end-tidal CO2 monitoring, or clinical indicators) should be acceptable.

5. Guidelines Appear More Protective of Payers Than Patients:
Overall, the proposed rules appear less focused on improving clinical outcomes and more focused on limiting access to care. This is especially concerning in a population of chronically ill patients for whom timely and appropriate ventilatory support can significantly improve quality of life, reduce hospitalizations, and prolong survival.

I urge CMS to revise this proposal by:

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I see many problems with this particular document. First of all, how are we to prove ongoing need with PCO2 >52 and also prove improvement in or normalizing of CO2 levels? These are contradictory. Once a patient reaches a certain degree of COPD and develops CO2 retention at baseline, it is unlikely to self-resolve without treatment (such as with NIV). I am not sure patients are going to be willing to start NIV therapy knowing they will require ABG testing every 6 months in perpetuity (as long as they have NIV therapy or until death). I am not sure what is meant by restricting RAD devices to patients who require higher max pressures, as it is the minute ventilation that improves hypercapnia, which is a function of rate and tidal ventilation - somewhat driven by pressures, but not completely? I am sure there are other issues...

Heather

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As a physician with over 15 years of experience caring for patients with chronic respiratory failure, I urge reconsideration of this proposal. Based on my clinical experience, this policy would not only delay life-prolonging care but also increase healthcare costs.

Patients with COPD who require noninvasive ventilation have exceptionally high hospitalization rates. Any delay in necessary ventilatory support would further elevate this risk. Moreover, the proposal is neither aligned with good clinical practice nor supported by the best available data. Additionally, many of the proposed requirements are not feasible for patients in such critical condition.

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There are several concerns regarding this proposed change. The requirement of IPAP > 20 cmH2O does not directly correlate with the severity of a patient’s disease. Tidal volume delivery depends on lung compliance and airway resistance, and a fixed pressure setting poses risks of both under- and over-ventilation. A more effective approach for home ventilation involves targeted tidal volume delivery through an automated device that adjusts pressure based on physiological parameters.

This approach is supported by the published study:
"Randomized trial of ‘intelligent’ autotitrating ventilation versus standard pressure support non-invasive ventilation: Impact on adherence and physiological outcomes"
Julia L. Kelly, Jay Jaye, Rachel E. Pickersgill, Michelle Chatwin, Mary J. Morrell, Anita K. Simonds

Additionally, the decision to initiate assisted ventilation should be driven by the patient’s disease state. Utilizing the GOLD staging for COPD would provide a more accurate method for determining the need for home ventilation.

Another critical issue in managing these patients is the lack of reimbursement for respiratory care in the home setting. Clinical follow-ups by a respiratory therapist (RT) are financially viable only when a patient qualifies for home non-invasive ventilation (NIV), as reimbursement rates for NIV are higher than for BiPAP. As these are fragile patients having a specialized clinician in the home has shown to improve compliance and decrease hospital admissions.

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I am a Respiratory Therapist with 27 years experience in the field. I currently work in home care. Most of my patients are COPD patients that have Chronic Respiratory Failure due to this pulmonary disease. I have seen the undeniable benefits that these patients receive using these devices. Not only have they been able to decrease the number of extended hospitalizations, but their quality of life is unequivocally better than before being on NIV/HMV. I have concerns about the Medicare proposal regarding these patients.

The requirements for COPD patients with chronic respiratory failure must be clearly defined and consistently applied by both Durable Medical Equipment (DME) providers and insurers across all Medicare variations, including all Advantage plans. Chronic respiratory conditions contribute to substantial costs associated with hospitalizations and unscheduled physician visits, which can be combatted through compliant use of Non-Invasive Ventilation (NIV), along with, appropriate medication management and early intervention.

To optimize patient access to NIV therapy, it is recommended that the qualifying Arterial Blood Gas (ABG) criterion be revised to a PaCO2 > 45 mmHg. Also, a patient's COPD treatment needs should not be compromised due to an overlapping OSA diagnosis (which these patients often have); the selection of an appropriate device to address both conditions should be determined by the physician.

Physicians should have the authority to assess patient benefit from therapy at any time and be able to switch patients to the most suitable device without unnecessary delays. Additionally, the 5 hour rule for compliance is not supported. Patients on ventilation devices often display issues necessitating ongoing monitoring and adjustments, particularly given the progressive nature of COPD and other lung conditions. Adherence rates may be affected by the need for setting adjustments or device transitions; therefore, “5 hours of usage per 24 hours” should not be a sole determinant for continued coverage. Any device usage should provide all the information needed to evaluate device appropriateness and make necessary changes. The physician, who is specifically trained in the management of this disease, should be the one to make these prescribed changes.

Proposing these, or similar, requirements…
If ventilation goals are not achieved from utilization of BiPAP with rate, patients should be able to transition to HMV (or NIV) at any time, once prescribed by the physician. The following should constitute when a patient would need to switch to a HMV (or NIV) versus a BiPAP with rate…
1. Testing during wake breathing would need to demonstrate hypercapnia with a PaCO2 >45 mmHg, as shown via ABG. (Normal PaCO2 levels are 35-45 mmHg.) and
2. Patient requires any of the following:

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I am a respiratory therapist with 26 years of experience in the home care field. Throughout my career, I have witnessed firsthand the significant benefits of HMV, including reduced hospitalizations and a decline in mortality rates among our patient population. Thank you all for the opportunity to send in comments on this proposal.

I want to start by respectfully disagreeing with the assertion that a patient exhibiting persistent hypercapnia, as demonstrated by a PaCO2 = 52 mmHg, is the only candidate requiring HMV therapy. While hypercapnia is indeed a crucial factor in assessing the need for such therapy, there is insufficient evidence to suggest that a COPD/CRF patient with a PaCO2 greater than 45 mmHg is not experiencing a chronic exacerbation that warrants HMV. Continuous monitoring and trend analysis over time are recommended to better assess the patient's condition.

Additionally, the combination of Pulmonary Function Tests (PFTs) and Arterial Blood Gases (ABG) will provide a more comprehensive picture of the patient's needs. Allowing for the inclusion of Venous Blood Gas (VBG) and End-Tidal CO2 (EtCO2) testing would be beneficial, particularly in outpatient settings. Limiting testing to values that can only be assessed in a hospital setting unnecessarily increases costs.

Furthermore, the statement that an individual must consistently use the prescribed device for at least 5 hours per day in a 24-hour period may not fully capture the patient's adherence. Adherence should be evaluated in terms of both duration and efficacy to ensure that the therapy is effectively achieving the intended therapeutic outcome. It is also important to consider how patients can be expected to adhere to the 5-hour per day requirement if they contract an upper respiratory infection or experience a power outage due to a storm. It is critical that we get clarification on the required duration of use per day, similar to the guidelines outlined in the Positive Airway Pressure (PAP) adherence Local Coverage Determination (LCD).

I would also like to address a concern regarding Medicare Advantage plans, including Humana and United Healthcare (UHC), which are currently denying coverage for HMV devices used in AVAPS-AE or iVAPS-AE modes of therapy, citing the classification under E0471. This classification reflects a lack of understanding regarding the functionality of these modes, ultimately impeding access to critical patient care. Both AVAPS-AE and iVAPS-AE modes enable volume-targeted ventilation, and the use of an HMV device allows for higher pressure and flow compared to an E0471 device. Additionally, these modes while used on HMV provide essential features such as backup battery support, alarms, and breath synchronization—features that are not available with E0471 devices. By limiting coverage for these modes, Medicare Advantage plans are depriving patients of vital therapeutic benefits.

Lastly, I believe that the requirement for oxygen therapy with an FiO2 = 36% or = 4L is not appropriate. A more individualized and tailored approach, considering fluctuations in the patient's condition, would be more suitable. It is important to recognize that COPD patients often require higher flow and volume for effective ventilation, which is not necessarily correlated with oxygenation needs. Excessive oxygenation in these patients can lead to detrimental effects, such as impaired CO2 elimination and suppression of the hypoxic drive, resulting in increased hypoventilation. I recommend removing the clause regarding the oxygen therapy requirement with an FiO2 = 36% or = 4L.

I urge that our treating physicians are allowed to complete a thorough evaluation of the patient's treatment plan to ensure that HMV is both appropriate and tailored to their patients' specific needs. Failure to provide treatment may lead to increased Emergency Room visits, potential hospital admissions, or premature mortality.

Thank you for considering my perspective on this matter.

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The rule restricts clinicians’ ability to prescribe optimal treatments based on their professional judgment.
It enforces specific, restrictive device choices and invasive testing requirements, ignoring less invasive and clinically effective alternatives commonly utilized in U.S. practice.

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As a respiratory therapist with over 50 years experience, I have worked with many patients dealing with chronic respiratory failure and have seen the positive results that this therapy offers, e.g., decreased unplanned medical encounters, decreased hospital admissions and length of stays and decreased morbidity. The patients that benefited experienced:

1. Two or more unplanned medical encounters, physician office and/or urgent care/emergency room visits and/or hospital admissions due to chronic respiratory failure associated with COPD, advancing neuromuscular disease or restrictive thoracic syndrome
2. Arterial blood gas results revealing persistent hypercapnea where arterial PaCO2 level was greater than 50 mmHg with elevated HCO3 levels
3. All other less costly options had been tried and failed and/or determined to be inappropriate given patient condition and comorbidities.
4. Patient was prescribed appropriate oxygen therapy and noninvasive ventilation capable of delivering and measuring weight appropriate tidal volumes
5. Patient were monitored for clinically appropriate compliance and therapy effectiveness by both specialty-trained in home and telehealth respiratory care professionals.
6. Outcomes consistently demonstrated 30 and 90-day decrease in hospital readmissions, 1 to 5 year decrease in mortality rates and overall improvement of quality of life.
7. Overall cost of care burden was significantly decreased.
8. This model proved to be extremely easy to implement, was cost-effective and had consistent reproducible results

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As discussed in the March 11, 2025 National Coverage Analysis (NCA) Proposed Decision Memo CAG-00465N, CMS is soliciting public comment on its proposed National Coverage Determination (NCD) titled Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD).

Humana appreciates CMS’ efforts to further define coverage criteria in this area, since as recognized by the Department of Health and Human Services Office of Inspector General (“OIG”), certain features of these types of devices can create opportunities for fraud, waste, and abuse. (OIG, Sleep Management, LLC: Audit of Claims for Monthly Rental of Noninvasive Home Ventilators, A-04-18-04066 (May 2021), available at https://oig.hhs.gov/oas/reports/region4/41804066.pdf.)

Humana respectfully requests that CMS explicitly state in the Proposed NCD that HMV devices that are capable of the AVAPS-AE and IVAPS-AE modes, be classified as a RAD, when they are being used strictly in these modes. The current language could benefit from additional clarity in this regard to avoid misinterpretation, inappropriate clinical decisions, or misuse in prescribing devices that are only suitable for specific diagnoses or health conditions.

For instance, some bi-level PAP (BiPAP) machines offer average volume-assured pressure support (AVAPS) and volume-targeted pressure support modes.
However, only AVAPS can be provided by a BiPAP RAD; iVAPS, iVAPS-AE, and AVAPS-AE are proprietary modes available only on specific HMVs (E0466), yet they are still bi-level modes. Additionally, current guidance under L33800 states that devices classified under E0466 used exclusively in bi-level PAP or CPAP mode are not eligible for reimbursement for any of the conditions described in L33800 even though the ventilator equipment may have the capability of operating in a bi-level PAP (E0470, E0471) mode. Moreover, a comprehensive literature review does not support the efficacy of iVAPS or 'AE' modes compared to BiPAP or AVAPS.

These same devices can also be used in true vent modes; therefore, we are not requesting that the device itself is classified as a RAD, but only when that device is strictly prescribed or used in those AVAPS-AE and IVAPS-AE modes for the duration of use.

Alternatively, if CMS classifies devices with those modes as an HMV regardless of the modes in which they are used, then Humana recommends that the coverage criteria include parameters around the modes themselves and under which conditions they are reasonable and necessary. For instance, patients would need to have first shown failure with a regular bi-level device with a backup rate before coverage of the more advanced apparatus is warranted.

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I think the only thing DME suppliers like us can ask for, is to please grandfather patient's who are already established with this equipment prior to your new effective date. There is nothing more difficult and damaging for patient's then ripping equipment that they are already comfortable with and are benefitting from. You kind of did that with Oxygen when those rules changed and it was super helpful.

Also asking for patients and Physicians to evaluate every six months seems excessive. It will create crippling work flows for small DMEs like us. We are a local non national company and asking for a follow up team for every six months is outrageous in our opinion. And you are asking for Medicare to pay for multiple office visits. Why can we just do annuals like Oxygen and CPAP supply users? I understand you are "stopping the bleeding" with unethical providers out there ordering these, but they are really life savers. Also asking suppliers to hand out E0470 & E0471 devices and then have to take it back when they fail and supply them vents.

We also need to recognize that Hospital BIPAPs(also a vent but always documented as BIPAP) and Home BIPAPs are completely different. Home BIPAPs Autos are designed for OSA— If that's not a factor, but they are hypercapnic, how can we justify that?? The Peak Flow is completely different. I think there needs to be more clinical evaluation before deciding clinical fate on that alone.

Thank you so much for your time and allowing us to give feedback.

Meagan P.

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Current CPAP and RAD continuing usage criteria include a criterion not only for number of hours per night (4 hrs) but a proportion of nights (70%). It is unlikely that patients will use a RAD or noninvasive HMV 100% of nights - patients may be hospitalized and not able to use their device, or may have an upper respiratory infection that precludes usage for a certain number of nights. In remote areas there may also be issues with data transmission. Recommend specifying a proportion of nights for which usage must be 5 hours/24 hours or more in the continuing usage criteria. Based on prior experience with the 70% of nights criterion, 70% is a logical extension of current policy.

The continuing usage criteria include PaCO2 improvement or normalization as two possibilities for demonstrating efficacy. Arterial blood gases for measurement of PaCO2 are not readily obtained in most office visits and cannot be obtained in most routine laboratories, given the need to process the sample in a time sensitive manner with a blood gas analyzer. Recommend that transcutaneous CO2 trend over time also be accepted as a demonstration of efficacy. Transcutaneous CO2 monitoring is frequently used in polysomnography and is an acceptable modality for justifying prescription of RAD or HMV across a variety of conditions that result in sleep related hypoventilation. Although there have been concerns about the accuracy of tcCO2 compared to ABG in recent studies, those same studies have supported the usefulness of the trend in tcCO2 values over time (Lambert et al.; Aarrestad et al.; Sørensen et al.; Setar et al.). It would thus be appropriate to use those values for ongoing monitoring, if not for initial qualification and diagnosis of hypercapnia.

References

Aarrestad, Sigurd, et al. “Diagnostic Accuracy of Simple Tools in Monitoring Patients with Chronic Hypoventilation Treated with Non-Invasive Ventilation; a Prospective Cross-Sectional Study.” Respiratory Medicine, vol. 144, Nov. 2018, pp. 30–35. PubMed, https://doi.org/10.1016/j.rmed.2018.09.015.

Lambert, Laura L., et al. “Accuracy of Transcutaneous CO2 Values Compared With Arterial and Capillary Blood Gases.” Respiratory Care, vol. 63, no. 7, July 2018, pp. 907–12. PubMed, https://doi.org/10.4187/respcare.05936.

Setar, Leah, et al. “Accuracy and Interpretation of Transcutaneous Carbon Dioxide Monitoring in Critically Ill Children.” Pediatric Critical Care Medicine: A Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, vol. 25, no. 9, Sept. 2024, pp. e372–79. PubMed, https://doi.org/10.1097/PCC.0000000000003564.

Sørensen, Kasper M., et al. “Agreement Between Transcutaneous Monitoring and Arterial Blood Gases During COPD Exacerbation.” Respiratory Care, vol. 66, no. 10, Oct. 2021, pp. 1560–66. PubMed, https://doi.org/10.4187/respcare.08510.

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As a respiratory therapist and representative of a company that provides NIPPV in the home for patients with chronic respiratory failure consequent to COPD, we have two concerns to submit.
1. As clinicians, we disagree with the "high intensity" pressure limitation to qualify patients for an E0471. The two most important settings on these devices are the pressure support (the difference between the inhalation and exhalation pressures, which creates the tidal volume) and the respiratory rate. This combination removes excess CO2 in this patient population. There are many patients who benefit from a combination of both of these settings but may not need (or be able to tolerate) an IPAP of more than 20 cmH2O. If the other qualifications are met, the patient should not be excluded from a device with a rate because the ordered IPAP is less than 20 cmH2O.
2. We need clarification on the coverage of the nasal mask or mouthpiece for mouthpiece ventilation. Currently, ventilator (E0466) supplies are not covered separately from the ventilator rental. The supplies for E0471 devices are covered, however you cannot achieve mouthpiece ventilation on that type of that device. Will all ventilator supplies now be separately billable from the rental? And the "extra" interface will also be covered for patients who need and qualify for MPV?

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I am writing to respectfully request that you consider incorporating End Tidal Capnography (ETCO2) into the proposed CMS policy for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD.
Patients suffering from chronic respiratory failure due to COPD often have severe comorbidities, are homebound, and may not have access to transportation. As arterial blood gases (ABGs) are not performed at home, obtaining these measurements poses a significant challenge for this patient population in terms of coverage eligibility.
ETCO2 provides a reliable and accessible alternative. It can be easily performed in a pulmonary physician’s office or at the patient’s home by a Medicare-approved Independent Diagnostic Testing Facility (IDTF). Additionally, clinical studies have demonstrated a strong correlation between ETCO2 and ABG measurements, supporting its validity as an effective tool for monitoring and managing these patients.
Please find below relevant clinical studies supporting the use of ETCO2 in this context.
Thank you for your time and consideration. I look forward to your response.
Please find the below clinical studies:

https://healthcare-bulletin.co.uk/article/correlation-between-end-tidal-co2-and-partial-pressure-of-carbon-dioxide-in-arterial-blood-in-patients-presenting-with-respiratory-distress-2398/

https://cejsh.icm.edu.pl/cejsh/element/bwmeta1.element.ojs-doi-10_15584_ejcem_2022_3_9

https://pubmed.ncbi.nlm.nih.gov/37799184/

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I am writing to respectfully request that you consider incorporating End Tidal Capnography (ETCO2) into the proposed CMS policy for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD.
Patients suffering from chronic respiratory failure due to COPD often have severe comorbidities, are homebound, and may not have access to transportation. As arterial blood gases (ABGs) are not performed at home, obtaining these measurements poses a significant challenge for this patient population in terms of coverage eligibility.
ETCO2 provides a reliable and accessible alternative. It can be easily performed in a pulmonary physician’s office or at the patient’s home by a Medicare-approved Independent Diagnostic Testing Facility (IDTF). Additionally, clinical studies have demonstrated a strong correlation between ETCO2 and ABG measurements, supporting its validity as an effective tool for monitoring and managing these patients.
Please find below relevant clinical studies supporting the use of ETCO2 in this context.
Thank you for your time and consideration. I look forward to your response.
Please find the below clinical studies:

https://healthcare-bulletin.co.uk/article/correlation-between-end-tidal-co2-and-partial-pressure-of-carbon-dioxide-in-arterial-blood-in-patients-presenting-with-respiratory-distress-2398/

https://cejsh.icm.edu.pl/cejsh/element/bwmeta1.element.ojs-doi-10_15584_ejcem_2022_3_9

https://pubmed.ncbi.nlm.nih.gov/37799184/

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Dear CMS Policy Team,

I appreciate the opportunity to provide feedback on the proposed decision memo regarding Medicare coverage for noninvasive positive pressure ventilation (NIPPV) in the home for chronic respiratory failure (CRF) due to chronic obstructive pulmonary disease (COPD). As a provider in the home medical equipment (HME) industry, I would like to share my perspective on the proposed changes and their potential impact on patient care.

Support for Coverage Expansion
The inclusion of Respiratory Assist Devices (RADs) with and without a backup rate, as well as home mechanical ventilators (HMVs), is a step in the right direction to ensure that COPD patients with CRF receive the care they need. Expanding access to high-intensity NIV and HMVs upon hospital discharge can significantly reduce hospital readmissions and improve long-term outcomes.

Concerns Regarding 180-Day Reevaluation Requirements
While I understand the need for ongoing assessments to confirm medical necessity, requiring reevaluations every 180 days places a burden on both patients and providers. Many COPD patients struggle with mobility and transportation, making frequent in-person evaluations challenging. I recommend that CMS consider allowing remote or telehealth evaluations to meet this requirement. Additionally, clear guidance is needed on what constitutes sufficient documentation to ensure continued coverage.

Clarification on RAD Usage Criteria
The requirement for “consistent use of the RAD for at least five hours per 24-hour period” may not fully reflect real-world patient adherence patterns. Some patients benefit from lower usage but still achieve clinical improvements. I urge CMS to consider flexibility in usage requirements, taking into account individual patient needs and provider documentation of clinical benefits beyond strict hourly adherence.

Reimbursement Considerations for HMVs and Related Supplies
The proposed inclusion of mouthpiece ventilation or an additional nasal mask for daytime use is important for patient adherence, but reimbursement policies must align to ensure that providers can supply these necessary accessories. CMS should clarify that additional supplies essential for HMV use, including tubing, filters, and humidification, will be covered appropriately.

Conclusion
Overall, this proposal represents progress in recognizing the value of NIPPV in managing COPD-related CRF. However, I encourage CMS to refine policies around reevaluation requirements, usage criteria, and reimbursement for necessary supplies to enhance access and ensure patient adherence. Thank you for considering these comments.

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I would like to express my support for the proposed decision memo on Medicare coverage for noninvasive positive pressure ventilation (NIPPV) to treat chronic respiratory failure due to COPD. These guidelines represent an important advancement in enhancing access to critical respiratory care for patients in need.

I appreciate the proposed coverage for both Respiratory Assist Devices (RAD) with and without backup rate features, acknowledging the diverse treatment needs of COPD patients. However, I strongly recommend that the follow-up evaluations required for continued coverage be specifically conducted by a licensed respiratory therapist for all device types. Their specialized training and expertise can ensure that patients receive optimal care tailored to their unique respiratory needs.

Moreover, it is crucial that reimbursement for RAD devices is sufficient to allow durable medical equipment companies to employ respiratory therapists to perform setups and follow-ups for these patients. Insufficient reimbursement could lead to reduced support and poorer patient outcomes. Adequate funding is necessary to ensure that patients receive the respiratory therapy they require, including the essential guidance of RTs in managing their equipment and addressing any challenges.

Additionally, with the growing prevalence of high-flow therapy integrated into modern home mechanical ventilators, I urge CMS to include high-flow therapy within the usage criteria. The clinical benefits of high-flow therapy are well-documented and can significantly enhance patient outcomes when used alongside noninvasive ventilation. Recognizing this in the guidelines could provide a more comprehensive approach to managing chronic respiratory conditions.

Thank you for considering my comments as you finalize these vital policies. Your efforts are crucial to improving the quality of care for patients with chronic respiratory failure.

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Current CPAP and RAD continuing usage criteria include a criterion not only for number of hours per night (4 hrs) but a proportion of nights (70%). It is unlikely that patients will use a RAD or noninvasive HMV on 100% of nights - patients may be hospitalized and not able to use their device, or may have an upper respiratory infection that precludes usage for a certain number of nights. Recommend specifying a proportion of nights for which usage must be 5 hours/24 hours or more in the continuing usage criteria. Based on prior experience with the 70% of nights criterion, 70% is a logical extension of current policy.

The continuing usage criteria include PaCO2 improvement or normalization as two possibilities for demonstrating efficacy. Arterial blood gases for measurement of PaCO2 are not readily obtained in most office visits and cannot be obtained in most routine laboratories, given the need to process the sample in a time sensitive manner with a blood gas analyzer. Recommend that transcutaneous CO2 trend over time also be accepted as a demonstration of efficacy. Transcutaneous CO2 montoring is frequently used in polysomnography and is an acceptable modality for justifying prescription of RAD or HMV across a variety of conditions that result in sleep related hypoventilation. Although there have been concerns about the accuracy of tcCO2 compared to ABG in recent studies, those same studies have supported the usefulness of the trend in tcCO2 values over time(Lambert et al.; Aarrestad et al.; Sørensen et al.; Setar et al.). It would thus be appropriate to use those values for ongoing monitoring, if not for initial qualification and diagnosis of hypercapnia.

References

Aarrestad, Sigurd, et al. “Diagnostic Accuracy of Simple Tools in Monitoring Patients with Chronic Hypoventilation Treated with Non-Invasive Ventilation; a Prospective Cross-Sectional Study.” Respiratory Medicine, vol. 144, Nov. 2018, pp. 30–35. PubMed, https://doi.org/10.1016/j.rmed.2018.09.015.
Lambert, Laura L., et al. “Accuracy of Transcutaneous CO2 Values Compared With Arterial and Capillary Blood Gases.” Respiratory Care, vol. 63, no. 7, July 2018, pp. 907–12. PubMed, https://doi.org/10.4187/respcare.05936.
Setar, Leah, et al. “Accuracy and Interpretation of Transcutaneous Carbon Dioxide Monitoring in Critically Ill Children.” Pediatric Critical Care Medicine: A Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, vol. 25, no. 9, Sept. 2024, pp. e372–79. PubMed, https://doi.org/10.1097/PCC.0000000000003564.
Sørensen, Kasper M., et al. “Agreement Between Transcutaneous Monitoring and Arterial Blood Gases During COPD Exacerbation.” Respiratory Care, vol. 66, no. 10, Oct. 2021, pp. 1560–66. PubMed, https://doi.org/10.4187/respcare.08510.

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To Whom It May Concern,

As a dedicated supplier of Durable Medical Equipment (DME), we appreciate the Centers for Medicare & Medicaid Services' (CMS) efforts to improve coverage criteria for noninvasive positive pressure ventilation (NIPPV) in the home setting. However, we have several critical concerns regarding the proposed rules that we believe require further consideration and revision to ensure fair access to care, appropriate clinical outcomes, and sustainable provider practices.

Arbitrary Daily Use Requirement:
The proposed requirement of five hours of continuous daily use as a benchmark for compliance appears arbitrary and unsupported by clinical evidence. We request clarification on the origin of this metric and the data used to establish it as a necessary threshold for effective treatment. Patients' needs vary significantly, and setting such a rigid criterion may inadvertently exclude those who benefit from shorter but equally effective usage patterns.

Continuous Oxygen Requirement:
Requiring patients to be on >4 liters per minute (LPM) of continuous oxygen alongside NIPPV imposes an unnecessarily restrictive criterion. Many patients with chronic respiratory failure due to COPD may not require that level of supplemental oxygen while still benefiting from NIPPV. This requirement could inadvertently deny appropriate therapy to those who do not meet this oxygen threshold but who nonetheless demonstrate a clinical need for noninvasive ventilation.

Unnecessary Six-Month Follow-Up:
The mandate for six-month follow-ups after the initial 180-day treatment period appears redundant for patients who have demonstrated compliance with the prescribed therapy. If a patient is adhering to the proposed five-hour daily use rule and showing clinical improvement, imposing additional follow-up visits every six months places an unnecessary burden on patients, caregivers, and providers. We propose that continued use should be determined based on clinical need rather than an arbitrary timeline.

Increased Provider Burden Without Reimbursement:
The proposed rules place significant administrative and financial burdens on DME suppliers without offering any corresponding increase in reimbursement. Compliance training, ongoing monitoring, six-month follow-ups, and additional interventions by licensed respiratory therapists represent substantial costs. These unfunded mandates threaten the viability of providers and may ultimately reduce access to care for patients in need.

Impractical Testing for Persistent Hypercapnia:
Requiring proof of persistent hypercapnia two weeks post-discharge is impractical and unrealistic. Conducting capnography in the home setting to obtain these measurements would require equipment and staffing that are not reimbursed under the current or proposed rules. Expecting DME providers to bear these costs is unsustainable and creates an unreasonable barrier to care.

Contradictory Requirement Regarding Hypercapnia:
Finally, noninvasive ventilation is specifically designed to treat and correct hypercapnia. Requiring ongoing proof of persistent hypercapnia to justify continued use contradicts the very purpose of the therapy. Successful treatment would naturally result in reduced hypercapnia, making it counterproductive to require proof of a condition that the intervention aims to resolve.

In conclusion, while we support CMS’s intention to enhance access to NIPPV, the proposed rules introduce several barriers that could negatively impact patient care and place undue burdens on providers. We urge CMS to reconsider these provisions and work collaboratively with stakeholders to develop guidelines that are both clinically sound and operationally feasible.

Thank you for your time and consideration.

Sincerely,

Tyler Riddle
MRS Homecare Inc.

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Patients with primary hypercapnic (excessive carbon dioxide; carbon dioxide retention) disease (COPD, Emphysema, and Obesity Hypoventilation Syndrome) can have dangerous Pc02 (Carbon dioxide) levels while maintaining a clinically appropriate PaO2 (Oxygen) level. It is important to recognize the medical need for mechanical respiration (non-invasive ventilation and BiPAP treatment) in patients with this disease process to avoid C02 toxicity, necrosis, and death. In studies completed over the last 5 years, NIPPV and BiPAP are the primary recommendation for hypercapnic disease. I have linked a study provided by a national ventilator supplier as well as a peer-reviewed journal article.

https://www.atsjournals.org/doi/10.1513/AnnalsATS.202009-1171AG
https://www.viemed.com/studies/

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