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

Additional information and clarification is needed for the following points prior to enforcing the new COPD policy.
-A setting of AVAPS-AE can only be accomplished by a ventilator (not possible on a lesser device) and the prescribed max pressure may be less than 30
-BiPAPs top out at a pressure of 25, How are DMEs to handle a prescribed pressure between 26-30 without a ventilator
-Remove the 6-month re-evaluation period and requalification language (costly and not best use of physician time), consider performing at annual exam as a compromise)
-Consider the removal of the requirement for PaCO2 = 52 mmHg
-Clarification for the language stating “sleep apnea is not the predominant cause of the hypercapnia”
-Include other testing methods (VBG, EtCO2, TcCO2, and PFT) for qualifying and monitoring therapy
-Remove the 2-week waiting period to validate “persistent hypercapnia” before initiating services or treatment
-Remove prescriptive language such as “high intensity therapy,” specific pressure or breath rate requirements and minimum use requirements
-Remove the FiO2 requirements under the HMV provision section
-Consideration for "grandfathering" existing patients to receive these services and not require them to re-qualify or limit access to service

Thank you.

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Recent revisions to the draft National Coverage Determination (NCD) for Respiratory Assist Devices (RAD) and Home Mechanical Ventilation (HMV) introduce a number of new requirements. While aimed at standardizing care, these changes risk unintentionally restricting access to life-sustaining respiratory support, particularly for individuals with a chronic progressive disease who already face systemic barriers to care.

This brief outlines six key concerns and corresponding policy recommendations to support equitable, clinically sound, and administratively feasible implementation.

Key Concerns and Policy Implications

1. Use of Non-Comparable International Studies to Justify Policy

Issue: The clinical trials cited to support the draft policy are predominantly European, conducted in healthcare environments that differ significantly from the U.S. system. Devices classified as RADs or NIPPVs in Europe are not identical to those used in the U.S., and care models differ—particularly regarding the role of respiratory therapists, which are separately funded in Europe..

Impact: The cited evidence does not translate appropriately to the U.S. clinical, regulatory, or reimbursement context, weakening the policy foundation.

Policy Recommendation: Re-evaluate the evidence base supporting the policy and prioritize U.S.-based data or adjust policy expectations to reflect real-world practice and systemic differences in delivery of care.

2. Retrospective Documentation Requirements

Issue: Patients currently dependent on RAD or HMV may lack legacy documentation that meets the proposed NCD criteria.

Impact: Enforcing retroactive compliance could result in inappropriate removal of devices, leading to preventable harm.

Policy Recommendation: Allow clinician attestation of benefit or implement grandfathering for established users.

3. Six-Month Re-Evaluation Requirement

Issue: Requiring evaluations every six months places an undue burden on patients with chronic conditions, particularly in rural or underserved areas.

Impact: May result in avoidable disruptions in care due to limited access or affordability of frequent follow-ups.

Policy Recommendation: Extend the interval to 12 months and allow telemedicine visits..

4. Mandatory Arterial Blood Gas (ABG) Testing

Issue: Requiring invasive ABG tests every six months is clinically excessive, often unavailable in most areas in the outpatient setting and ignores alternative, less burdensome diagnostic tests such as venous blood gas (VBG) or end-tidal CO2 (ETCO2).

Impact: Patients in community settings may lose access to care due to facility limitations of not having the ability to perform an ABG test. Desperate patients could be forced to admit themselves into an Emergency Room in order to obtain an ABG test so their HMV isn't denied and taken away from them.

Policy Recommendation: Eliminate mandatory ABG Testing as it is redundant as it adds no value to patients clinical outcome or to reducing costs

5. Five-Hour Daily Utilization Requirement

Issue: The five-hour daily usage standard exceeds current clinical benchmarks and lacks evidence of additional benefit.

Impact: Could unjustly penalize patients and create significant logistical issues for device suppliers and clinicians.

Policy Recommendation: Align with established adherence criteria (=4 hours/night, 70% of nights over 30 consecutive days within the first 180 days).

6. Continued Usage Criteria for Capped Rental Devices

Issue: RADs (E0470, E0471) are capped rental items with ownership transferring to patients after 13 months. Requiring continued usage documentation for an item that is no longer renting is illogical.

Impact: Unnecessary documentation imposes confusion and burden without affecting reimbursement or care delivery.

Policy Recommendation: If continued usage requirements are needed then Reclassify RADs when used for CRF subsequent to COPD to the "frequently and substantially serviced" category, consistent with HMV (E0465, E0466).

7. Initial Coverage Criteria – Access to HMV for Mouthpiece Ventilation Users

Issue: The draft NCD lacks clarity and flexibility around initial qualification for HMV for individuals using mouthpiece ventilation—a common and essential method for those with COPD.

Impact: Patients who require mouthpiece ventilation but do not meet rigid nocturnal criteria may be excluded from accessing HMV, despite clinical necessity.

Policy Recommendation: Modify initial coverage criteria to explicitly recognize mouthpiece ventilation as a valid method for qualifying for HMV in appropriate clinical contexts.

8. Required Ventilator Usage Within 24 Hours Prior to Discharge

Issue: The current requirement for documented ventilator use within 24 hours of discharge lacks practical guidance and may be inconsistently interpreted.

Impact: Without clarity, this provision could delay discharge or impede therapy initiation due to documentation ambiguities.

Policy Recommendation: Revise the requirement to state that the supplier-provided HMV device must be applied and used by the patient in the hospital within 24 hours prior to discharge to document clinical effectiveness and tolerance of the provider supplied HMV.

Conclusion
The draft NCD introduces new challenges for access and continuity of care, especially for the most medically fragile populations. Thoughtful revisions are needed to ensure that coverage policy protects both the integrity of the Medicare program and the well-being of its beneficiaries.

We urge CMS to:

Prioritize patient safety and access to essential therapies,
Align policies with current clinical and reimbursement standards, and
Reduce administrative burdens on providers, patients, and suppliers.

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Re: CMS Proposed National Coverage Determination (NCD) for Noninvasive Positive Pressure Ventilation (NIPPV)

Barnes Healthcare Services, a fourth-generation, family-owned healthcare provider with over a century of experience serving patients across the Southeast, appreciates the opportunity to provide comment on the proposed NCD for NIPPV. We remain committed to our mission: to keep patients healthier, at home, and out of the hospital through responsible and clinically appropriate respiratory therapy.

While we support CMS’s goal to ensure effective and medically necessary use of NIPPV, we are deeply concerned that the policy as currently proposed will negatively impact patient outcomes, access, and healthcare sustainability—particularly in rural and underserved communities.

1. Continuity of Care – Grandfathering Must Be Included
The proposed policy does not address how patients currently on therapy—often for years—will be protected. Many do not have the retrospective documentation now being required. These patients have benefited immensely from this therapy, and removing it could result in rapid health decline, hospitalization, or death. A clear grandfathering provision must be included to safeguard continuity of care and avoid preventable harm.

2. Clinical and Administrative Burden – Impractical and Harmful
The six-month re-evaluation requirement and mandatory arterial blood gas (ABG) testing introduce significant administrative and clinical burdens that disproportionately affect the most vulnerable—those who are homebound, chronically ill, or living in rural areas with limited access to specialty care.

Further, requiring ABGs fails to align with modern clinical practice. The GOLD (Global Initiative for Chronic Obstructive Lung Disease) standards recognize Pulmonary Function Testing (PFT) as the gold standard for COPD staging and diagnosis. ABGs are invasive, burdensome, and unnecessary for many stable patients.

Alternative and less invasive tests—venous blood gases (VBGs) and end-tidal CO2 (ETCO2)—are widely used and should be considered acceptable in appropriate cases. CMS’s current proposal does not reflect this clinical reality and could deter physicians and patients alike from pursuing or continuing therapy.

3. Unrealistic Adherence Thresholds and Lack of Flexibility
The proposal’s requirement of 5 hours/day of use on average exceeds current CMS adherence benchmarks, which define adherence as =4 hours per night on 70% of nights within a 30-day period. The new threshold lacks clinical justification and will likely result in unnecessary therapy discontinuation, even among patients who are otherwise benefiting from therapy.

Equally problematic is the lack of exceptions for unavoidable interruptions, such as:

Hospitalizations
Short-term rehabilitation stays
Power outages due to natural disasters or storms
Patients cannot control these events, yet the proposed policy penalizes them, creating inequities and systemic failure in managing chronic respiratory disease.

4. Systemwide Impact – Higher Readmissions, Higher Costs, Lower Quality of Life
CMS’s intent to ensure the most cost-effective equipment is used must not override the need to ensure clinically appropriate therapy for each patient’s disease state. Many patients require high-intensity NIPPV—which is more costly but far more effective in preventing exacerbations and readmissions. Restricting access to these therapies will result in:

More frequent and severe hospital admissions
Increased emergency department visits
Strain on already overburdened hospitals
Worse quality of life for patients
Long-term financial loss to the Medicare system
We urge CMS to recognize that NIPPV—when deployed appropriately—keeps patients at home, reduces readmissions, and saves the healthcare system millions of dollars. Rather than destabilizing this infrastructure, CMS should bolster it with thoughtful, evidence-based policy.

Conclusion
Barnes Healthcare Services respectfully urges CMS to:

Include grandfathering provisions for existing patients
Align qualification criteria with current clinical standards
Adopt more flexible and practical documentation pathways
Phase in any major changes gradually with provider and stakeholder input
CMS has the opportunity to protect vulnerable patients while supporting innovation and sustainability in respiratory care. We urge CMS to revise this NCD in partnership with frontline providers who deliver this care every day.

Let’s not trade progress for policy.
Let’s build forward—together—with patients at the center.

Thank you for your time and attention.

Kelly Griffin, Director of Respiratory
Barnes Healthcare Services
We Take Care of People. We Impact Lives Every Day. We Are Leading the Transformation of Healthcare.

Supporting Clinical Evidence for Review
As Published in Chest, September 22, 2014

COPD Management Programs Utilizing NIPPV Reduce Hospital Admissions
Treatment of patients with chronic obstructive pulmonary disease (COPD) places a financial burden on the US healthcare system, with most of the cost resulting from hospitalizations for acute exacerbation of the disease. The use of non-invasive ventilation (NIV) in patients with severe COPD as a means of preventing subsequent hospitalization is currently controversial.

We retrospectively assessed the experience of one home care company (Barnes Healthcare Services, Valdosta, GA) whose program includes oxygen, NIV, education, nutrition counseling, and respiratory therapist (RT)-led respiratory care. As titration of NIV can be difficult, with limited expertise in this methodology being available in most US locations, Barnes elected to place patients on an auto-titrating non-invasive ventilator (Trilogy 100 from Philips Respironics) using the average volume assured pressure support mode with auto-expiratory positive airway pressure (AVAPS-AE). This device/mode:
a. Automatically titrates EPAP to eliminate sleep apnea if present.
b. Automatically regulates pressure support to a physician-defined target tidal volume, based on ideal body weight. This yields high-intensity NIV automatically.
c. Maximizes expiratory time to help avoid breath-stacking and adjusts the back-up rate based on the patient’s spontaneous rate.

Patients with severe COPD were placed on the Barnes program if they were hypercapnic (PaCO2 > 45mmHg) and had been hospitalized twice in a single year with an acute COPD exacerbation. 398 such patients entered the Barnes program and we compared their admission rates in the year before and after their enrollment. The Barnes program, using the AVAPS-AE mode of ventilation to deliver high-intensity ventilation, reduced the number of hospital admissions in these 398 COPD patients by 719 (87.7%) in the year following their enrollment (Table 1).

At the allowable reimbursement rate for NIPPV (E0464 - $1537.95/month), implementing the Barnes program over this year for all 398 COPD patients cost payers approximately $7.3 million. However, reducing hospital admissions by 719 saved an estimated $15.3 million at an inflation-adjusted 2014 cost per COPD admission of $21,323, delivering a total healthcare cost saving estimated at $8 million. In addition, the 1-year survival rate (82%) of this patient population was similar to that reported in patients using high-intensity NIV in a recent German trial (88%).

Number of Admissions % Patients Pre-Enroll % Patients Post-Enroll 0 0% 87.7% 1 0% 10.1% =2 100% 2.2% Table 1: Admissions amongst the 398 COPD patients enrolled in the Barnes program

Although there were a number of components to this COPD management program, the data suggests that utilizing AVAPS-AE may potentially improve health outcomes and survival in selected patients with COPD, while reducing healthcare costs.

Authors:
S. Coughlin, PhD – Director of Strategy, Health Economics and Reimbursement, Philips Respironics
A. Day – Barnes Healthcare Services, Valdosta, GA
W.E. Liang, PhD – Global Biostatistics, Clinical Affairs, Philips
D. White, MD – Professor of Medicine, Harvard Medical School, Division of Sleep Medicine

Contact:
Steven Coughlin, PhD – steven.coughlin@philips.com | Tel: +44 151.345.4329

References:

American Lung Association. COPD Fact Sheet. May 2014.
Barnes Healthcare Services Ventilation Management Program. Study MAH-14-0166 COPD. 2014. Data on file.
Storre JH et al. Respir Care. 2014;59(9):1389-1397.
Menzin J et al. Respir Med. 2008;102(9):1248-1256.
Köhnlein T et al. Lancet Respir Med. doi: 10.1016/S2213-2600(14)70153-5.

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As a longtime therapist working in the DME industry, I am urging you to postpone/delay your new proposed guidelines for NIV/HMV on the home. There are many issues with what is being proposed and lots of questions that are unclear in these new guidelines. Clinically there are several issues with how you are proposing these COPD patients causing them greater hardship as well as delays in getting them the appropriate treatment. This will also cause an increased burden on the providers, physicians, and hospitals in a system that is already struggling to treat patients with the increased cuts in reimbursement and denials from the insurance companies to provide the appropriate care for their patients. These guidelines are not reasonable and are setting these patients up for failure causing them increased hospitalizations with decreased quality of life.

There is also no mention of what is going to happen to existing patients that are using NIV/HMV that have been on this equipment for a long time and benefitted greatly from using it with proof that substandard pieces of equipment failed to adequately treat their hypercapnia. I am urging you to consider these patients as human beings and not just a way that you can cut costs. Treat them as your family member and how you would feel if it was them that is now having to give up equipment that has given them back their ability to be able to have a better quality of life. I am asking you to please grandfather these patients in.

There are many other issues that I feel need to be addressed but first and foremost, these proposed guidelines need to be delayed until there can be more clinical review and I would hope that you allow input from the respiratory therapists and pulmonologists that deal with these patients and equipment to help develop a more reasonable and beneficial means of treating the COPD population

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We appreciate the opportunity to provide feedback on the CMS Proposed Decision Memo (CAG-00465N). After careful review, we respectfully recommend that CMS maintain the existing RAD LCD and NIV NCD policies, which remain both clinically and operationally appropriate. The proposed decision memo, as currently written, presents several clinical and operational challenges that would result in eligible patients discontinuing therapy—putting them at risk of hospitalization, health deterioration, or death.

If CMS proceeds with implementing the current NCA, we urge a delay of at least one year to allow manufacturers, suppliers, and providers to update systems, specifications, and compliance protocols. This transition period is essential to prevent disruption of life-sustaining therapy for current patients and ensure access to appropriate equipment for future patients.

Additional Recommendations from DASCO:

April 10, 2025

Dr. Mehmet Oz
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Kimberly Long
Lead Analyst, 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 Dr. Oz and Ms. Long,

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 respiratory assist devices, home mechanical ventilators, and sleep therapy devices, to more than three-quarters of the Medicare beneficiaries who rely upon these therapies to maintain their independence and enhance their quality of life. The CQRC members also employ approximately 35,000 people in the United States.

The members of the CQRC prioritize patients being able to access the right equipment, at the right place, and at the right time. Every day 1.5 million Americans depend upon home respiratory therapy to maintain a high quality of life while receiving the health care treatments they need. In order to maintain this patient-centered approach, we work closely with physicians and those health care providers who prescribe respiratory therapy equipment that improves patients’ quality of life, reduces preventable hospitalizations and other medical complications, and reduces patients’ out-of-pocket costs, as well as overall Medicare spending.

In the case of NIPPV, several peer-reviewed studies using CMS data have demonstrated that when compared with those diagnosed with CRF consequent to COPD who do not receive a home mechanical ventilator (HMV), beneficiaries who have the therapy experience fewer emergency department visits, fewer hospitalizations, and lower mortality.[1] These studies find that the earlier the treatment begins, the better the outcomes for the patients. The most recent study conducted by Dobson & DaVanzo found that beneficiaries who received HMV within the first week of a CRF consequent to COPD diagnosis have $2,182 lower monthly health care costs than beneficiaries with the same diagnoses who did not receive the device.[2]

Given this strong evidence, it is imperative that the Trump Administration establish the right balance that provides clear and objective guidance to physicians prescribing HMV and other respiratory assist devices (RAD) that provide NIPPV, but also does not create such a burden on patients that Medicare has to expend otherwise unnecessary dollars for emergency department visits, hospitalizations, or additional health care services because patients could not access the right equipment to allow them to remain in their homes at the optimal time.

Thus, while we appreciate that the NCA seeks to bring clarity to the coverage requirements for RAD and HMV devices, we are concerned that the current draft decision memo creates unnecessary barriers that will restrict access to these devices for the very beneficiaries who medically require them. As a result, these patients will likely experience more hospitalization and higher overall health care costs. In addition, we are concerned that as currently drafted the policies do not allow physicians to properly manage CRF consequent to COPD at its earliest stages. Given the Trump Administration’s focus on addressing chronic disease in America, it would be short-sighted to adopt a policy that is so restrictive that it limits physicians’ ability to manage this chronic and deadly respiratory condition.

To address these concerns, the CQRC urges CMS to adopt the following recommendations as part of the final NCD memo. In brief, the CQRC asks CMS to:

• Grandfather coverage for existing NIPPV patients without requiring them to meet the new criteria;
• Establish the effective and implementation dates one year after the final memo is published to avoid potential gaps in coverage due to implementation barriers;
• State explicitly that CMS will adopt a clear and objective set of clinical data elements to be used in a paper or electronic “template” for contractors to use to document the criteria requirements;
• Adopt specific modifications to the proposed criteria:
  o Remove RAD pressures requirements to avoid unnecessarily treating patients with settings that may not be appropriate;
  o Revise the usage standard for RAD devices so that it requires use for at least 4 hours nightly, for 70% of the nights within a 30-day period;
  o Permit patients to use widely accepted tests for determining CO2 levels instead of permitting only the painful, invasive, and expensive ABG test;
  o Revise the ongoing assessment requirements to align with the capped rental period for RAD devices and establish a one-year assessment for patients prescribed HMV devices to address unnecessarily burdensome patient obligations and avoid gaps in coverage;
  o Permit physicians to prescribe RAD devices at a lower testing threshold, consistent with the American Thoracic Society (ATS) clinical guidelines and, if viewed as necessary to support such coverage, require evidence to be submitted to evaluate the clinical appropriateness, which would be similar to a coverage with evidence determination.

We provide details about each recommendation in the remainder of the letter.

I. Grandfather coverage for existing patients without requiring them to meet the new criteria.

The draft criteria are not aligned with current practice which means that few, if any, patients have medical records documenting that the new criteria have been met. Unless they are grandfathered in, these patients could lose access to their life-sustaining devices. That could create continuity of care problems, negatively impact their outcomes, and increase overall health care expenditures.

Similarly, if CMS were to require existing patients to requalify for devices they have already been prescribed and using, these patients could experience continuity of care problems as well. Patients who seek to requalify would have to incur otherwise unnecessary additional cost sharing. Some may be unable to schedule the necessary doctor’s appointment and undergo the invasive testing required in a short timeframe. Other may not meet the testing criteria, especially if they have been successfully managing the disease by using the prescribed device and their CO2 levels have dropped below the testing threshold. CRF consequent to COPD is not curable; patients are managed using the devices, not cured.[3] If they do not meet the new requirements, they would no longer have access to the life-sustaining equipment they have been prescribed which may result in otherwise preventable hospitalizations, complications, or death.

An analysis by Health Management Associates (HMA) of the CMS 5% File found that only about 2% of RAD/HMV patients had an office or outpatient visit where a blood gas test was conducted. The vast majority of those patients who were tested were only testing once during the calendar year. According to HMA, any policy requiring visits for blood gas testing will produce a significant burden on patients relative to current clinical practice.[4] As CMS has noted in other areas of payment and coverage, accessing physicians or hospital-based procedures (such as an ABG test) can be nearly impossible in rural areas, especially those living in medical deserts. Approximately 77 percent of rural counties in the United States are so-called medical deserts, owing to a shortage of primary care professionals, according to the National Rural Health Association.[5] Moreover, we have heard from physicians that once a patient begins using a device, if that device is removed or downgraded to a lower level device because of failing to meet new coverage requirements (which has occurred recently in the Medicare Advantage program), the vast majority of their patients have been hospitalized and died. While there may not yet be publicly available data to quantify this problem, CMS should take into account the dire consequences associated with removing existing patients from RAD and HMV devices.

Thus, even if CMS were to provide for a year of transition, it is unlikely that all of the existing patients would meet the new requirements. To protect beneficiaries who already rely upon these devices, we urge CMS to grandfather them into coverage and not require them to try to meet the new requirements.

II. Establish the effective and implementation dates one year after the final memo is published to avoid potential gaps in coverage due to implementation barriers.

Implementing the new requirements will require suppliers and manufacturers to work together to ensure that existing devices are equipped with the remote monitoring technology, which not all devices currently include. Manufacturers will have to create and disseminate new software which will require more effort than a common system upgrade. Based on our conversations with manufacturers, it could take a minimum six months to complete the basic programming and additional months to ensure that all of the reports typically provided to suppliers and physicians are complete. Moreover, suppliers would then have to update and/or replace the existing equipment to adjust to these modifications. We understand that a substantial number of patients use devices today that do not include the modules necessary for tracking usage and remote monitoring. In addition, some patients rely upon devices that do not have the ability to provide remote monitoring data and such devices will have to be upgraded. Some patients, especially in rural areas, may not have access to the broadband services necessary to support such monitoring. Suppliers will also need to update their practices and procedures and retrain staff to adhere to the new coverage requirements. To avoid patient disruptions in treatment, there needs to be sufficient time to implement these changes. Based on an estimate of our members that manufacture RAD and HMV devices, we recommend that the implementation period be one year from the data of publication of the final decision. This period will account for the time it will take to update equipment, software, and protocols to support a seamless transition to the new policies.

III. State explicitly that CMS will adopt a clear and objective set of clinical data elements to be used in a paper or electronic template for contractors to use to document the criteria requirements.

Our members agree that it is appropriate for patients to be able to access HMV without having to risk hospitalization or death by being placed on another device first or not having access to any device when their physicians believe the device is the most appropriate treatment option for the individual patient. However, documenting this discretion should not be left to faxed medical record chart notes. CMS should ensure that prescribers know what information is necessary to establish medical necessity.

Our experience with supplemental oxygen demonstrates that if physicians or other prescribers are not specifically told what data elements must be completed in a clear and objective manner, Medicare audit contractors will require suppliers to obtain highly personal and confidential medical record notes in their efforts to determine medical necessity as defined by the NCD. However, physicians rarely write notes that meet the contractors’ views of what is necessary to establish the coverage criteria. In the area of supplemental oxygen, CMS CERT data for the last ten years demonstrates that the vast majority of claims are denied as “improper payments” based on insufficient medical record notes, despite the patient actually meeting the coverage criteria.[6] When this situation occurs, suppliers are placed in an untenable situation: they can either remove the life-sustaining device (if the patient will even agree to that course) or allow the patient to maintain it, which could be an illegal inducement under federal and state law.

CMS should not allow this situation to occur in the case of RAD and HMV devices. While we appreciate that a final NCD is not the place to establish a specific template, the document could clearly delineate the specific data elements that will be required to establish medical necessity. For example, what is meant by the cognition requirement and how should that be documented? What evidence will be needed to support the physician’s discretion as discussed in the draft decision memo? We urge CMS to include a section or appendix that sets forth these clinical data elements in the final memo. If the final NCD includes these clinical data elements, then contractors, prescribers, and suppliers will have a clearer understanding of the requirements which will promote adherence to the policies without jeopardizing patient access.

IV. Adopt specific modifications to the draft criteria.

Based on conversations with the health care professionals with whom we work, the proposed criteria related to the high-intensity pressure requirement, usage minimums, the type of test permitted to evaluate patients, the testing thresholds, the ongoing in-person assessment requirements create significant access barriers to patients and will lead to higher Medicare costs without providing commensurate benefit. To address these concerns, the CQRC makes the following recommendations for modifying the proposed criteria in the draft decision memo.

a. Remove RAD pressures requirements to avoid placing patients on a device that is not appropriate.

Under the draft decision memo, a RAD with backup rate feature must be utilized in the high intensity mode (IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute). The proposal to restrict patients who cannot tolerate IPAP >20 to a RAD without a backup rate is without precedent and not based on clinical outcomes data. In fact, clinical literature supports not imposing such a limitation.[7] The inability to tolerate high IPAP should have no bearing on whether RADs with backup rate are covered.

The proposed policy would eliminate access for patients for whom the device could be used to delay the onset of a more severe form of this chronic disease and would make patients suffer needlessly. This outcome seems contrary to the stated goal of the Trump Administration and the Secretary to address the chronic disease epidemic in America. The draft criterion would prohibit access to RADs with back rate for patients who cannot tolerate the high intensity pressure, thus preventing them from accessing a treatment option that could address immediate symptoms and potentially delay the onset of later stages of this chronic disease. Denying access will force patients to suffer unnecessarily and lead to potentially higher health care costs.

This proposal also would prevent physicians from ordering volume assured pressure support (VAPS) for their CRF consequent to COPD patients with peak inspiratory pressures (PIP) less than 20 cmH2O, because this mode is not available in a RAD without backup rate. This would create further issues with access to care for patients who require the VAPS mode for therapy. Most importantly, the RAD without backup rate device is not intended for use to treat CRF or ventilation insufficiency. RAD with backup rate devices are intended to treat obstructive sleep apnea (OSA) and not to treat ventilation failure of any degree (see manufacturer clinical guides). This requirement places respiratory patients on devices that are not intended to treat COPD, CRF, or any ventilation insufficiency condition.

Thus, we ask that CMS revise this policy so that hypercapnic patients who qualify for RAD would have access to E0471 RAD with backup rate regardless of pressure or rate settings as long as their treating practitioner believes it is the appropriate medical treatment for the patient.

b. Revise the usage standard for RAD and HMV devices to require usage for at least 4 hours nightly, for 70% of the nights within a 30-day period.

The final policy should adopt the current usage standard for RAD devices of at least 4 hours nightly, for 70% of the nights within a 30-day period during the initial trial. The draft NCD memo would require “an average of at least 5 hours per 24-hour period.” While increased device usage generally correlates with better patient outcomes, raising the compliance threshold from 4 to 5 hours carries significant implications for patient management workflows and product updates, which could ultimately disrupt patient care.

Implementation of the 5-hour criterion would unfairly deny continued access to ventilation therapy for many patients who compliantly use and benefit from the device but do not meet the average hourly threshold. Such a result seems counterintuitive to the Trump Administration’s focus on reducing the high cost of chronic disease through better management. If patients cannot access a device until they need it 5 or more hours a day, they will experiences otherwise preventable morbidity and expensive care – including emergency department visits and hospitalizations – that could have been prevented if their physicians were permitted to management them with the appropriate device at the right time consistent with the individual patient’s prognosis.

c. Permit patients to use widely accepted tests for determining CO2 levels instead of limiting testing to only the painful, invasive, and expensive ABG test.

Another challenge with the draft decision memo relates to mandating a painful, invasive, and expensive test to confirm patient need when less intrusive and less costly test are available and relied upon today. Many patients do not have access to hospitals or specialty facilities that have the blood gas testing equipment. The growth of hospital deserts especially in rural America is well documented.[8] Some patients may not be able to afford the cost sharing associated with a hospital visit and an expensive ABG test. As a result, patients may not be assessed as the proposed policy envisions. If patients cannot access ABGs for continued coverage qualification, then suppliers would be forced to pick up the equipment or risk punishment under the inducement laws. As a result, patients would experience greater morbidity, lower quality of life and even risk death. The Medicare program would also incur the greater costs associated with these negative clinical outcomes.

There are other clinically acceptable tests, such as venous blood gas (VBG) test, transcutaneous tests, and ENTCO2 test, that would allow patients more flexibility and lower cost-sharing obligations when being evaluated. Clinical experts have indicated that these tests are appropriate when prescribing RAD and HMV devices for restrict thoracic disorder and neuromuscular diseases.[9] While ABGs may be the gold standard, physicians not working within a hospital setting currently use other tests to assess their patients. Some hospitals are using VBGs more frequently given the pressures associated with the Medicare bundled payments.

The CQRC supports using other objective test results as a criterion for determining hypercapnia and the appropriateness of prescribing a RAD or HMV. Medicare policy should not leave behind Americans living in rural America, especially those already experiencing limited access to health care services.

d. Revise the ongoing assessment requirements to align with the capped rental period for RAD devices and establish a one-year assessment for patients prescribed HMV devices to avoid gaps in coverage.

Under the draft policy, patients would be required to continue to see their doctor and obtain new test results 180 days after receiving a device and then at least every 6 months after, which includes having to undergo an ABG test each time. As noted in previous parts of this letter, many patients who rely upon RAD or HMV devices live in areas where they may not have easy access to a hospital setting to obtain an ABG. Many people, whether living in rural or urban areas, often experience substantial barriers to being able to make an appointment with their physician more than once a year. As noted above, this requirement would be an entirely new obligation on patients. As previously referenced, HMA found that only 0.011 percent of current patients see their physician every 6 months. The additional cost to Medicare and beneficiaries of adding a substantial number of physician visits every year, not taking into account the increased cost associated with the ABG tests, should be considered before finalizing this policy.

An ongoing assessment every 6 months is an excessive and unduly burdensome requirement for this patient population living with chronic, progressive respiratory disease. In-person pulmonology evaluations every 6 months will be especially difficult for elderly, ill patients with transportation challenges and those in rural areas, who often have limited access to specialists. If patients cannot access their physician, they would no longer qualify for the equipment. If the device is removed from their home, this chronic disease would continue to progress without proper management, leading to greater morbidity, more emergency department visits, more hospitalization, and even death. Not allowing physicians to help manage this chronic condition is antithetical to the stated desire of the Trump Administration to reduce the burden of chronic disease in America.

To reduce patient burden and incentivize compliance, we recommend that CMS modify the assessment in two ways. First, because RAD device reimbursement is capped at 13 months, it is unnecessary to require patients to be reassessed after that period ends. We recommend eliminating the assessment requirements for RAD devices after the end of the RAD capped rental period. For HMV, we ask that CMS rely upon an annual certification, which could include remote monitoring or telehealth, to lessen the burden on patients and promote patient compliance. These recommendations seek to ensure that patients will comply with appropriate medical assessment requirements by minimizing the burden and cost-sharing obligations patients incur when required to have more frequent appointments.

e. Permit physicians to prescribe RAD devices at a lower testing threshold, consistent with the American Thoracic Society (ATS) clinical guidelines and, if viewed as necessary to support such coverage, require evidence to be submitted to evaluate the clinical appropriateness similar to a coverage with evidence determination.

Finally, the CQRC is concerned that by focusing RAD and HMV coverage on patients with ABGs of 52 mmHg or greater, the policy creates a significant gap when it comes to treating this chronic disease. The ATS practice guidelines recommend beginning therapy for hypercapnic respiratory failure due to COPD when at FEV1/FVC??45 mmHg; not during exacerbation.[10] Yet the proposed testing threshold would prohibit patients from accessing a device, even if their physicians believes the patient would clinically benefit from using it. The draft decision memo would thwart efforts to manage the chronic disease earlier in the process.

We appreciate that there may be no direct randomized controlled trial (RCT) related to this threshold, but many procedures, devices, and drugs that Medicare covers do not have RCT support. We understand that some of the studies identified in the draft decision memo focused on patients with average testing values of 52 mmHg, but that should not preclude the option for patients to receive treatment at the earlier stages of the disease, especially because these devices can delay the onset of greater morbidity and reduce the need for emergency department visits and hospitalization. The positive patient outcomes and lower costs associated with the use of these devices identified by Dobson and DaVanzo include patients with values less than 52 mmHg because there is no such restriction in place today.

We believe CMS should prioritize patients and help them to adopt treatment options to manage this chronic condition. To that end, we recommend that CMS finalize a coverage pathway that allows physicians to prescribe and patients to access RAD and HMV devices at 45 mmHg, consistent with the ATS guidelines, with an evidence requirement to allow CMS to obtain additional data to allow for an ongoing evaluation of the devices at this level.

V. Conclusion

The CQRC’s preference would be for CMS to maintain alignment among the three disease states, which includes neuromuscular diseases, thoracic restrictive diseases, and CRF consequent to COPD, for which HMV devices are prescribed. That would mean not adopting the HMV-related policies in the draft decision memo, but rather retaining the current policy[11] which preserves physician discretion in prescribing these devices. To provide additional clarity, we are recommending the adoption an objective set of clinical data elements that contractors could rely upon to establish medical necessity. In terms of the RAD devices, we appreciate that some physicians have found it challenging to have their patients meet the current LCD criteria. However, the draft decision memo, as described above, includes coverage criteria for RAD devices that if implemented without change would not improve the situation. Therefore, if CMS were not willing to adopt the modifications suggested in this letter, the CQRC members would prefer maintaining the existing LCD and NCD to ensure that at least the current level of patient access is not eroded further. In sum, the CQRC remains concerned about several aspects of the draft decision memo, but supports the adoption of the RAD proposals if the modifications recommended in this letter are adopted.

Please do not hesitate to reach out to our executive director, Kathy Lester, if you have any further questions.

Sincerely,

Jeff Barnhard
Chairman
Council for Quality Respiratory Care

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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The COPD Foundation (COPDF) appreciates the opportunity to comment on the National Coverage Analysis Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (tracking number CAG-00465N). COPDF has long supported the reconsideration request that led to this analysis and we salute the Centers for Medicare and Medicaid Services (CMS) for the hard work and diligence invested since. Keeping coverage determinations in alignment with best practices and current evidence helps ensure that Medicare beneficiaries with COPD receive optimal, efficient care.

We are concerned that some elements of the current draft decision memo do not fully align with those best practices and have the potential to create significant barriers to accessing respiratory assist devices (RADs) and home medical ventilators (HMVs). Such barriers may have significant impacts on all aspects of care delivery, from increasing prescriber workloads to reducing availability of devices from suppliers to increasing beneficiaries’ risk of expensive emergency care and hospital admissions. Accordingly, we respectfully request CMS reconsider the following proposed elements of the decision memo:

High-Intensity Mode Requirement:
“High intensity ventilation” is a general concept with no consensus definition based on available evidence. Some established clinical practice guidelines (notably the Canadian Thoracic Society’s recommendations for the use of noninvasive ventilation in COPD https://cts-sct.ca/wp-content/uploads/2021/05/20210507_CTS-LT_NIV_COPD-Guideline-Publication.pdf) do use this terminology, but these recommendations are also stated to be conditional (indicating little agreement in published evidence) with low certainty (suggesting that a uniform approach for all patients is not necessarily indicated). Many patients need time to adapt to high inspiratory pressures, and starting immediately at the relatively high pressure called for in the decision memo will likely have a negative impact on tolerance and therefore adherence to therapy. In addition, a defined requirement limits the ability of prescribers to use their clinical judgment and expertise when designing an individualized treatment plan. We therefore recommend this requirement be struck from the final determination.

Re-evaluation Criteria:
COPD is often considered a “progressive” disorder, with symptoms gradually worsening until end of life. While this is a relatively simplistic view of what is increasingly recognized as the highly variable course of COPD, it is fair to say that for most people, symptoms generally do not “go away.” Thus, the requirement for patients to be re-evaluated every six months imposes significant financial and logistical demands on patients with no clear rationale. We recognize and support an initial re-evaluation 180 days after the initial prescription, but subsequent re-evaluations represent an unnecessary burden and should be removed from the final determination.

We also recommend reconsideration of the requirement for arterial blood gas (ABG) testing to determine blood CO2 levels. ABGs are admittedly the gold standard diagnostic tool for evaluating chronic hypoxemia and hypercapnia, they are more expensive, more painful, and more intrusive than other commonly-available tests that provide results with similar fidelity. In addition, the specialized testing equipment may not be readily available. This is especially true in rural settings, many of which are increasingly known as “medical deserts” (https://www.healthcare-brew.com/issues/rural-care-deserts). If patients are not able to obtain appropriate testing to maintain eligibility, suppliers would then be forced to remove beneficial therapy equipment at the risk of financial penalties and the patients themselves would be at greater risk for negative outcomes. Several other tests, including venous blood gas (VBG) sampling and end-tidal CO2 testing, are cost-effective, commonly available, and clinically equivalent; we therefore recommend these be added as testing options.

Implementation Strategy:
We encourage CMS to delay the effective date of the new NCD for one year after publication. Several of the new requirements will require close cooperation between equipment manufacturers and durable medical equipment suppliers to provide updated devices and/or software that are compliant with the updated policy. One calendar year should provide sufficient time to accomplish this, as well as to account for any other potential implementation issues. We further recommend that CMS permanently grandfather coverage for beneficiaries receiving RAD/HMV therapy at the time of implementation. We note that the draft criteria, while an appropriate step forward, do not align with current practice. Many patients may therefore not have appropriate documentation of clinical need for these devices and would be at risk of having their equipment removed. Similarly, the need for requalification may create significant care coordination and access issues, further increasing the risk of negative outcomes and increased healthcare utilization/costs. For patients who have been benefiting from these devices, this represents a wholly unnecessary risk with no foreseeable benefit.

COPDF believes these edits to the draft decision memo ensure that Medicare beneficiaries will receive evidence-based care to manage their chronic respiratory failure in a fashion that optimizes outcomes while minimizing burdens not only on them, but on prescribers, suppliers, manufacturers, and other stakeholders. We appreciate this opportunity to advocate on behalf of our community and to encourage the implementation of guidelines that will further address the impact of chronic disease on America’s healthcare infrastructure.

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The decision does not grandfather in patients already receiving RAD [respiratory assist devices] or HMV [home mechanical ventilators]. Patients already relying on these devices are unlikely to have the documentation required by the draft NCD in their medical records. If a physician/prescriber believes that the patient continues to benefit from the device, it would be inappropriate to remove the device from their home and risk hospitalization or death.

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. Many patients may not have the financial ability to cover the cost-sharing required by these additional visits. This could lead to delays or disruptions in critical treatment, worsening health outcomes.

Strict qualifying criteria, such as requiring a painful and invasive ABG draw is unnecessary and burdensome for this chronically ill patient population. Excluding the use of other reliable and less invasive tests like VBG or ETCO2 will further limit access to care, particularly in rural areas lacking specialty facilities.

The “five-hour” usage requirement is inconsistent with industry standards and policies. The proposed decision would require patients to use NIPPV for an average of five hours per day to remain compliant, but the requirement is not consistent with current industry standards and policies, which define adherence to therapy as using PAP for =4 hours per night on 70% of nights during a consecutive 30-day period anytime during the first three months of initial usage. Such a requirement would be burdensome on both the patient and provider given the lack of remote monitoring in usage on most NIV patients.

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Thank you for the opportunity to provide feedback regarding the proposed changes. First, please consider grandfathering in patients who are already on RAD or HMV therapy. Taking away a device that is working for them may cause detriment to a patient’s care.

RAD
1. The high intensity ventilation setting of IPAP > 20 cmh20 and back up rate of 14 has the potential to restrict treatment options for this patient population. Patients can still benefit from utilizing PAP with a lower pressure and rate to successfully maintain hypercapnia. This restriction does not take the unique patient needs into consideration. One example being tolerance of high PAP pressures. Why would we force a patient to be on higher pressure when they don’t clinically need them?
2. When discharging from a hospital, frequently the settings of hospital PAP devices can differ from the options/settings we can offer in the home. Using the settings for home for 24 hours prior to discharge may not be an option in the hospital.
3. Continued usage requirements at 6 months may be challenging depending on the patients access to follow up with their provider in addition to additional administrative burden and delay in payments to the DME. Options such as tele-health should be offered.
4. More clarity to the usage requirements should be given. 5 hours per night differs from what the industry uses as a standard with PAP.

HMV
1. Determining PaCo2 levels should not be limited to ABG’s. It should include VBG’s and ETCo2. All 3 are reliable sources to determine the PaCo2 levels.
2. Continued usage requirements at 6 months may be challenging depending on the patients access to follow up with their provider in addition to additional administrative burden and delay in payments to the DME. Options such as tele-health should be offered.

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The public comment submitted by Humana is deceptive and includes false and misleading information about the Department of Health and Human Services (“HHS”), Office of Inspector General’s (“OIG”) audit of VieMed HMV claims.[1] On appeal the HHS ALJ rejected OIG’s analysis and conclusion and confirmed the medical necessity of all appealed claims.[2] Humana complains of HMV overutilization and fraud, waste, and abuse by DME suppliers trying to provide lifesaving respiratory care to chronically ill patients. In doing so, Humana misses the opportunity to proactively develop its own HMV medical policies that would inevitably result in higher quality respiratory care for Humana beneficiaries at lower costs.

References:
[1] 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.
[2] Viemed Healthcare, Inc., Viemed Wins Complete Overruling of Appealed OIG Claims Resolving Multiyear Process With HHS and CMS, Press Release (January 23, 2023) (https://viemed2018if.q4web.com/news-releases/press-release-details/2023/Viemed-Wins-Complete-Overruling-of-Appealed-OIG-Claims-Resolving-Multiyear-Process-With-HHS-and-CMS/default.aspx).

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As a former Medicare Program Integrity Analyst and a former Medicare Congressional Liaison, I am writing to express my deep concerns regarding the proposed decision memo on Medicare coverage for Noninvasive Positive Pressure Ventilation (NIPPV) in the home for chronic respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD).

First and foremost, I strongly urge CMS to include a grandfather clause for NIPPV devices already in use by beneficiaries. Many patients have relied on this therapy for years with measurable improvement in quality of life and reduced hospitalizations. Removing access to these life-sustaining devices would not only jeopardize their health and well-being but also increase emergency department visits and hospital admissions—ultimately raising costs and straining an already overburdened healthcare system. A grandfather clause would protect these vulnerable patients and reflect Medicare’s commitment to its beneficiaries.

Secondly, the proposed six-month re-evaluation requirement presents unnecessary and unreasonable burdens for patients with chronic conditions. Many of these individuals already struggle with mobility and access to care. Mandating a biannual reassessment will disproportionately impact those with limited support systems or transportation, leading to lapses in therapy and preventable health deterioration.

Additionally, the requirement for arterial blood gas (ABG) testing as the sole method for reassessment is unnecessarily invasive. Alternative, clinically accepted options such as venous blood gas (VBG) testing or end-tidal CO2 monitoring should be permitted. These methods are far less burdensome and equally effective for monitoring patients’ respiratory status. Limiting providers and patients to a single testing option undermines the principle of patient-centered care. It should never be limited to only one option.

The proposed 5-hour daily usage requirement is also concerning. Currently, Positive Airway Pressure (PAP) therapy compliance is defined as use for at least 4 hours per night on 70% of nights. There is no clear rationale for deviating from this long-established standard. Physicians, who are most familiar with their patients’ individual needs and responses to therapy, should have the discretion to determine whether NIPPV is benefiting their patient, rather than relying on arbitrary hour-based metrics.

Lastly, I want to emphasize that Medicare is a program earned through a lifetime of payroll contributions. Beneficiaries deserve a healthcare system that supports—not limits—their ability to live with dignity and health in their later years. This proposal, as written, threatens to reverse years of progress in managing chronic respiratory conditions, particularly for our most vulnerable populations. The barriers it creates—whether through reassessment requirements, invasive testing, or arbitrary usage thresholds—run counter to the mission and values of Medicare.

NIPPV is a proven therapy that improves respiratory function and reduces hospitalization. To restrict access now, especially without accommodations for current users, is to risk increased morbidity, decreased quality of life, and greater financial burden on the healthcare system.

I respectfully urge CMS to reconsider this proposal in its current form. Your final decision will directly impact thousands of Medicare beneficiaries. Please ensure it supports their health, safety, and dignity.

Thank you for your time and thoughtful consideration.

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On behalf of the members and suppliers of the VGM Group, Inc. (“VGM”), we want to thank you for the opportunity to submit comments on the NCA for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for Treatment of Chronic Respiratory Failure to COPD (CAG-00465N).

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 collection 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 that allows the beneficiaries to be treated in their home while relieving stress on the inpatient hospital capacity.

During our review of the proposed NCA for NIPPV in the home for treatment of CRF secondary to COPD, the following lists recommendations and considerations:

The American Association for Homecare (“AAHomecare”) is providing the Centers for Medicare and Medicaid Services (“CMS”) comments on the Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD proposed NCA. There is a compelling need for CMS to make substantive changes to the Proposed NIPPV NCA, and delay implementation until those changes can be made. As drafted, the Proposed NIPPV NCA will create unnecessary barriers to essential care. This is due to proposed overly prescriptive criteria that will interfere with the physician’s ability to exercise their medical judgement and ensuing requirements for durable medical equipment (“DME”) suppliers that are virtually impossible to comply with.

If CMS does not address the identified issues before finalizing the policy, it will likely severely impact current service levels and compromise beneficiary access to ventilation therapy that saves dollars and avoids costly hospital readmissions, while decreasing mortality rates.

AAHomecare is the national association representing durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) suppliers, manufacturers, and other stakeholders in the home care/home medical equipment community. Our members manufacture, distribute and provide medically necessary DMEPOS items and services to patients in their homes.

Executive Summary:

If CMS does not address the following four critical parts of the proposed NCA, there will be a serious risk to these fragile patients’ ability to receive life-sustaining therapy.

Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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I do not think we should be making it more difficult to obtain NIV devices for patient with COPD or any other patient with chronic hypercapnic respiratory failure. These patients can have significant morbidity and mortality related to episodes of acute on chronic hypercapnic respiratory failure. They also end up having high utilization of healthcare resources through their multiple hospital admissions. It is unrealistic to get an in-lab polysomnography on these patients for multiple reasons. These patients are sick, and many times they cannot remain in the outpatient setting long enough to even make it to an appointment for an in-lab sleep study. The process also puts them at undue risk of having an exaxcerbation while waiting for the results of a study and for them to receive a device. It is much more cost-effective and efficacious (from a medical standpoint) to get these patients approved for NIV prior to leaving the hospital.

I also feel that using a RAD device is not an appropriate replacement for true NIV. I have found that using Average Volume Assured Pressure Support (AVAPS) ventilation is much more effective. This mode of ventilation allows us to better achieve minute ventilation and tidal volume goals. It also allows for the machine's settings to evolve with the patient. For instance, if a patient has Amyotrophic Lateral Sclerosis (ALS) and requires NIV, their settings are going to change over time because their neuromuscular weakness will worsen over time. Having a device that can adjust to the patient's ventilatory needs automatically ensures that the patient receives the ventilatory support they need without delays in care that would be incurred if they needed to have repeated sleep studies or titration studies.

Saving a few dollars up front by using RAD devices instead of portable home ventilators is not worth the increased healthcare costs related to exacerbations and subsequent hospitalizations, nor is it worth the negative health impacts that it may have on the patient's who require chronic ventilatory support.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Comment#1: Requirement for a COPD patient who required Bilevel w/ Back up Rate—-requiring that a patient meet "high intensity" therapy criteria for a back up rate IPAP of > 20 and a respiratory rate > 14 will only produce poor outcomes. There are no specific head to head trials that demonstrated decreased hospital admissions and increased patient compliance with therapy on higher pressures and higher back up rate. COPD patients pressure requirements are indivicual and many times require many adjustments lower and higher to maintain compliance at different stages in their disease process or during exacerbations. Requiring a specific pressure to qualify for a NIPPV with back up rate will potentially eliminate this mode of therapy for COPD patients who have difficulty tolerating a higher pressure, but require a back up rate and will decrease the chances that they will tolerate the use of the device for 5 hours, increasing hospital re-admissions .

Comment#2: It is already challenging in the home setting for patients to meet the 4hour of nightly use; Many of our COPD patients have comorbidities such as edema, anxiety and depression related to their symptoms and challenges that interfere with sleep and could prevent them from sleeping 5 hours per night immediatley disqualifying them for Bilevel therapy simply because they have other comorbidities.

Comment#3: Requiring invasive testing such as an ABG, to maintain coverage at 180 days is unrealistic especially in rural areas, the burden of travel in our area among the COPD population is very challenging, , with oxygen equipment, finding assistance for transportation, every 180 days for follow up and testing visits or even rural rides will prove difficult. Compliance data should be the driver for continued use of the equipment and increased follow up to keep the equipment should not be required. It is clearly documentated and cannot be altered. Not to mention the burden on suppliers to pick up and redeliver equipment when qualified, This challenge will likely push patients to decline therapy and increase hospital readmissions and exacerabations.

Comment#4: It is unrealistic to place a noninvasive ventilation patient on the same device that is in place in acute care. Many times higher level devices are placed in different modes to ahieve NIPPV settings and titrate the patient prior to discharge. The language should be updated to require the mode and settings, not the device, required just prior to discharge to maintain appropriate outcomes during admissions, which will at times also be less that 20cm of IPAP and < 14 bpm.
Noninvasive ventilation is working to help with COPD readmissions, making the rules so specific and not allowing individual determination of required pressures for best outcomes will likely increase re-admissions and decrease compliance.

Thank you.

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Subject: Comment on Proposed NCD for Noninvasive Positive Pressure Ventilation (NIPPV)
To Whom It May Concern:
My name is Robert A. Minicucci, and I serve as Vice President of Strategy at Health System Services (HSS), a respiratory care provider supporting patients across New York State. Our team includes registered respiratory therapists, discharge specialists, and operational leaders who engage daily with individuals who rely on RAD and NIV therapies—particularly those living with COPD and chronic respiratory failure.
We appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) for noninvasive positive pressure ventilation (NIPPV). The feedback below reflects our direct clinical experience and frontline observations from supporting patients, coordinating discharges, and managing ongoing therapy in the home.

________________________________________

1. High IPAP Threshold (=20 cm H2O) Is Too High for Many Patients
The IPAP threshold of 20 cm H2O is potentially too high to be tolerated by many patients, especially those new to therapy. This could lead to non-compliance and potential loss of coverage, even when therapy is clinically appropriate.
“An IPAP of 20 is not something we even start at in hospitals. It’s very high and rarely tolerated by patients, especially those who are frail or new to therapy.” — Emilia Heberle, RRT
These standards risk disqualifying patients who need a RAD with a backup rate but cannot tolerate such a high pressure setting, particularly elderly or underweight COPD patients.

________________________________________

2. Auto BiPAP Is Clinically Inappropriate for Many COPD Patients
The fallback pathway, “without backup rate,” effectively forces patients into either an overly aggressive 20 cm H2O threshold, or an auto BiPAP device which may be insufficient. But auto BiPAPs are designed to treat obstructive sleep apnea—not hypercapnic respiratory failure.
“Auto BiPAPs are designed to respond to upper airway collapse, typical of sleep apnea. The problem is, COPD is an obstructive disease, and these patients are trapping CO2. With an auto BiPAP, there would be no trigger for a pressure increase if patients aren’t getting enough breaths in. This could cause discomfort using the device, which decreases adherence to therapy—or even worse, cause the patient to become hypercapnic and be readmitted to the hospital.”
— Spencer Fritsch, Respiratory Therapy Manager
“If their CO2 levels go up, they could become obtunded or acidotic. It affects mental state, kidneys, organs—it’s not just about breathing.”
— Emilia Heberle, RRT
This mismatch could result in under-treatment, CO2 retention, and clinical deterioration—even when patients appear adherent on paper.

________________________________________

3. Hospital Discharge Provision
The policy states that home equipment must match the device used in the final 24 hours of inpatient care. This is disconnected from clinical reality:
“Hospitals often don’t have the right equipment available. Many use BiPAP ST by default because units like the Philips V30 are recalled and unavailable.”
— Rob Minicucci, VP Strategy
“They stabilize the patient on the floor with what’s available—not necessarily what they need long-term. Then we’re left trying to justify suboptimal therapy after they leave the hospital.”
— Emilia Heberle, RRT
This approach risks locking patients into incorrect therapy based solely on institutional limitations prior to discharge.

________________________________________

4. ABG Testing Requirement
Requiring a repeat ABG every six months is excessive and burdensome. ABGs are invasive, painful, and often not clinically necessary for stable patients. Additionally, these tests cannot be performed at widely accessible labs such as Quest Diagnostics, meaning patients must travel to specialty facilities, incurring additional time and cost. “ABGs are invasive and painful. They carry risks like hematomas and arterial spasms. And they’re not necessary for stable patients.”
— Emilia Heberle, RRT
“Even pulmonologists call us asking where they can send patients for outpatient ABGs. There are almost no outpatient options—certainly not in rural areas.”
— Spencer Fritsch, RT Manager
CMS should permit clinically accepted alternatives like venous blood gas (VBG), end-tidal CO2 (ETCO2), or transcutaneous CO2 (TCO2), which are less invasive and more accessible.

________________________________________

5. Six-Month Re-Evaluations Are Operationally Burdensome and Poorly Defined
The six-month re-evaluation mandate would be extremely difficult for many chronically ill patients to meet, particularly those living in rural areas or with limited mobility. Many already face challenges attending annual appointments. This increased burden could lead to lapses in care, unnecessary costs, and poorer health outcomes. “Patients in rural areas can’t make two visits a year. They may not have transportation, may need a caregiver to go with them, or may not be physically able.”
— Josh Bach, Director of Clinical Services
“Telehealth used to fill this gap, but right now the future of those rules are unclear. Right now, we don’t even know if telehealth visits will count.”
— Andrew Schultz, Compliance Analyst
Travel to appointments for excessive testing presents challenges to patients affected by social determinants of health, and causes further procedures that are billed to insurance.
Additionally, the policy is silent on whether this requirement ends after one re-evaluation—or continues indefinitely. That ambiguity could trigger an unsustainable compliance burden for providers and patients.

________________________________________

6. Usage Threshold of 5 Hours/Day Is Vague and Unfounded
The proposed requirement that patients use their device an average of 5 hours per 24-hour period introduces major confusion:
“Current PAP therapy compliance is 4 hours on 70% of nights over 30 days. Why would this be different? There’s no science showing that 5 hours is a better benchmark.”
— Andrew Schultz
“What does 5 hours per day even mean? Every single day? Any 30-day window?”
— Josh Bach
The nuance of 5 hours vs the current standard of PAP therapy compliance requirements creates unnecessary confusion and administrative burden. Meanwhile, compliance software isn’t even built to measure this. The effort of manually tracking these patients separately, or building the systems to accommodate this un-based requirement will be costly. Further, there are significant concerns that the unclear language could lead to arbitrary denials, audit risk, and widespread confusion during implementation, which would negatively impact patient access to therapy.

________________________________________

7. Lack of Grandfathering for Current Patients
The proposed policy lacks provisions to grandfather in patients currently using RAD or HMV therapies. These patients may not have documentation that satisfies the new criteria, despite long-term successful use.
“We don’t know if patients already on therapy will need to go through new evaluations, ABGs, or even get requalified for resupply.”
— Andrew Schultz
Forcing removal of their equipment risks a gap in care that could lead to hospitalization or worse—especially when their treating physicians confirm continued medical benefit from the device.

________________________________________

8. Downstream Concerns: Readmissions and Clinical Decline
We’ve seen firsthand what happens when appropriate therapy is delayed, denied, or removed:
“They come back confused, fatigued, short of breath. They miss meds. They wind up in the ED within days. This is how readmissions happen.”
— Emilia Heberle, RRT
These outcomes are not hypothetical—they are predictable, preventable, and deeply tied to equipment access and continuity of care.

________________________________________

Recommendations
To ensure patients retain access to medically appropriate, life-sustaining care, we urge CMS to revise the draft NCD as follows:
1. Lower or remove the =20 cm H2O IPAP threshold.
2. Acknowledge the limitations of auto BiPAP for COPD patients.
3. Remove the hospital discharge device-matching requirement.
4. Allow less invasive CO2 monitoring (VBG, ETCO2, TCO2).
5. Clarify and limit the six-month reevaluation requirement.
6. Align usage thresholds with existing PAP policies.
7. Include a grandfathering provision for current patients.
We support CMS’s efforts to improve respiratory care outcomes and align policy with best practices. But this proposal—if implemented as written—will reduce access, increase costs, and negatively impact patient health. Our team would welcome the opportunity to collaborate further.
Sincerely,
Robert A. Minicucci
Vice President, Strategy
Health System Services

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April 10, 2025

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

Comments on the Proposed Decision Memo Re: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD: CAG-00465N

Dear Ms. Syrek Jensen:

Lincare is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (“CMS”) proposed decision memo related to coverage of non-invasive ventilation. We share your commitment to patients living with chronic obstructive pulmonary disease (COPD) and our experience shows us that care provided to beneficiaries in their homes is both clinically efficacious and cost effective. We also know that the patients we have the honor to serve prefer to be in their homes and communities.

Lincare is one of the nation’s largest providers of oxygen and other respiratory therapy services to patients in the home. We provide services and equipment from over 717 operating locations in 48 U.S. states and employ approximately 11,000 people. The vast majority of the nearly 2 million patients we serve are Medicare beneficiaries.

In reviewing the proposed decision memo, a number of issues stand out to us as risks and operational impediments to providing Medicare beneficiaries with the high-quality respiratory care they need to maximize independence and quality of life. We will walk through each of these issues below, and we believe that CMS should provide the community with another opportunity to review and comment on changes made to the proposed decision memo before it takes effect, given the complexities of the patient care ecosystem these vulnerable beneficiaries rely upon. The home respiratory equipment supplier community, represented by the Council for Quality Respiratory Care (CQRC), the American Association for Homecare (AAHomecare), and the VGM Group, share our concerns and will be commenting separately as part of the NCD process.

Consistent with our industry partners, Lincare’s preference would be for CMS to maintain alignment among the three disease states (neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to COPD) for which home mechanical ventilators (HMV) are prescribed. That would mean not adopting the HMV-related policies in the draft decision memo, but rather retaining the current policy, published in the Medicare National Coverage Determinations Manual Chapter 1, Part 4, section 280.1, which preserves physician discretion in prescribing these devices. To provide additional clarity, we recommend adopting an objective set of clinical data elements that contractors could rely upon to establish medical necessity. In terms of the respiratory assistance devices (RAD), we note that some physicians have found it challenging to have their patients meet the current RAD LCD criteria. However, the draft decision memo, as described below, includes coverage criteria for RAD devices that if implemented without change would not improve the situation. Therefore, if CMS were not willing to adopt the modifications suggested below, Lincare recommends maintaining the existing RAD LCD and Medicare National Coverage Determination to ensure that the current level of patient access is not eroded further. Lincare remains concerned about several aspects of the draft decision memo and would only support its adoption if the modifications recommended in this letter are adopted.

In framing our overall analysis, we would draw your attention to a recent analysis of Medicare data completed by the health economics consulting firm Dobson DaVanzo. Their analysis, which will be submitted as a separate comment, shows that, as we would expect, patients receiving non-invasive ventilation at home (NIVH) achieve better health care outcomes than similar patients who do not receive NIVH treatment. NIVH patients enjoy lower risk of death, less frequent inpatient admissions, fewer emergency visits, and cost the Medicare program less.

Grandfathering Current Patients. The proposed decision memo does not include any information related to how existing patients will be affected by a new coverage policy. Given that the draft policy differs significantly from current practice, few, if any, of our current patients will have medical record documentation that satisfies new criteria. At a minimum, it is unlikely that qualified medical record documentation will be within the possession and control of the supplier responsible for submitting claims. We strongly urge that these patients be grandfathered in a final decision memo, so they remain covered and retain access to the life-sustaining devices on which they depend. The importance of ensuring continuity and stability for current patients cannot be overstated. Changing the rules for current patients would result in confusion, complexity and cost. We believe grandfathering current patients would also be consistent with precedent, as CMS permitted current CPAP and RAD users to retain their eligibility without retesting when CMS changed its coverage policy in 2011. Specifically, the 2011 Medicare policy for PAP (Positive Airway Pressure) compliance included provisions for grandfathering. This allowed patients who were already using PAP devices before the policy change to continue their treatment without being subject to the new compliance requirements. Grandfathering ensured that existing users wouldn't face disruptions or additional hurdles in their ongoing therapy.

If CMS were to require current patients to requalify, thousands of the elderly and disabled patients we serve would be subjected to the difficulties and inconveniences of additional doctor appointments and the related cost sharing burden, all in a very short timeframe. In many areas of the country, it could take patients up to 6 months to obtain an appointment time. Some of our patients who have been successfully managing their conditions may find that they do not meet testing criteria (unless they were to undertake the risk of discontinuing device usage to prepare to be retested. Failure to meet the new requirements would result in discontinued coverage which for this population will lead to preventable hospitalizations, complications and even unnecessary deaths.

Implementation Timeline. Our understanding is that CMS would envision implementing policy changes included in a final decision memo at the time of publication. We strongly urge CMS to delay implementation for at least one year from the date of final publication to allow suppliers and manufacturers the necessary time to update equipment, systems, programming and protocols needed to ensure a smooth transition. The new requirements will require suppliers and manufacturers to work together to ensure that existing devices are equipped with remote monitoring technology, which not all are today. Manufacturers will have to create and disseminate new software which will require more effort than a more common system upgrade. Moreover, some patients rely upon devices that do not have the ability to provide remote monitoring data, and such devices will have to be upgraded. During the COVID-19 pandemic, there was a shortage of modem devices used for remote monitoring of patient data that resulted in the purchase of many devices without remote monitoring capabilities.

Suppliers will also need to update their practices and procedures and retrain staff to adhere to the new coverage requirements. To avoid patient disruptions in treatment, there needs to be sufficient time to implement these changes. Sudden change will be disruptive to beneficiaries and clinicians. We also worry about device capacity for all the patients who will have to be quickly transitioned to new equipment. A controlled and collaborative transition will prevent confusion and abrasion.

Initial Coverage Criteria for RADs. The proposed decision memo would require that initial coverage of RADs would start with devices that have and utilize a high intensity ventilation mode (IPAP > 20 cmH2O and back up rate >14. Beneficiaries who cannot tolerate these settings could then move to a bilevel device without a backup rate, effectively decreasing the level of therapeutic intervention. This would have the effect of eliminating access for patients relying on ventilatory support to delay the onset of more severe stages of COPD by prohibiting access for those who cannot tolerate high intensity. Likewise, in order to be eligible for NIPPV therapy, the beneficiary would need to have essentially tried and failed RAD therapy and show a need for a higher level of support that could not be provided by the initial device dispensed. Typically, this would be the population of COPD patients on NIPPV to manage immediate symptoms with the longer-term goal of preventing disease progression. Not only does it prolong access to the necessary therapeutic benefit that can be derived from NIPPV therapy, but it also requires multiple equipment changes and acclimation periods for the beneficiary and would impact thousands of beneficiaries.

We would recommend that the high intensity mode criterion or any other tried and failed type criteria be removed from a final decision memo. Physicians should be the ones to prescribe appropriate respiratory interventions for their patients.

Consistent Use Definition. The proposed decision memo would define consistent use for RAD devices as 5 hours per 24-hour period. We agree that increased utilization generally correlates to better patient outcomes. However, we do have operational concerns related to patient management workflows and product updates, complicating compliance. Denying coverage to beneficiaries who consistently use their equipment but may find it difficult to stretch to an additional hour per day will put them at risk of negative health outcomes including emergency room visits and hospital admissions. We recommend that CMS adopt the 4 hours/70 percent of the time standard that is used for other respiratory devices.

Reducing Testing Burden. We have a number of recommendations that we would describe as reducing the burden of testing. Specifics include:

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As someone who works daily to improve processes and reduce barriers to care, I want to echo our team’s deep concern about the proposed NCD for NIPPV.

At Barnes Healthcare Services, we’ve been caring for patients across the Southeast for over 100 years, and we’ve seen firsthand how vital noninvasive positive pressure ventilation (NIPPV) can be—especially for patients in rural or underserved communities. While we understand CMS's intent to ensure appropriate use, the current draft would do more harm than good.

Patients already on therapy risk losing access due to documentation requirements that were never part of their original care. This could lead to hospitalizations—or worse.

The added testing and evaluation requirements (like ABGs every six months) are incredibly burdensome and often unrealistic for the homebound patients we serve. There are safer, simpler alternatives that should be accepted.

The new 5-hour/day adherence requirement doesn’t align with industry standards and could push more patients off therapy, even when they're benefiting from it.

The policy’s broader impact would be destabilizing. Providers like us, who focus on complex, long-term care in rural areas, would be hit hard—making it harder for patients to get what they need.

Barnes supports a smarter path forward—one that’s patient-centered, realistic, and phased in with support. We’re ready to partner with CMS to help make that happen.

Thanks for the opportunity to comment—and for listening to the people doing the work on the ground.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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CMS,

We believe the proposed NCD regarding NIPPV patients will be a burdensome administrative process that will negatively impact patients with significant respiratory challenges who depend on this life-sustaining care.

Our main concerns are:

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Dear CMS Decision-Making Committee,

On behalf of SuperCare Health, I appreciate the opportunity to comment on the proposed National Coverage Determination (NCD) concerning Non-Invasive Ventilation (NIV) and Home Mechanical Ventilation (HMV). While we support CMS’s intent to standardize and enhance care for individuals requiring ventilatory support, we respectfully request consideration of the following critical revisions to the policy to ensure patient access, clinical appropriateness, and alignment with evidence-based practice.

1. Removal of the PaCO2 = 52 mmHg Requirement
This specific threshold does not reflect clinical variability or the spectrum of chronic hypercapnic respiratory failure. Strict cutoffs may delay necessary intervention and fail to capture patients who would benefit significantly from earlier therapy.

2. Clarification or Removal of the Statement: “Sleep apnea is not the predominant cause of the hypercapnia”
This language is ambiguous and potentially exclusionary. Many patients present with overlapping conditions, including obesity hypoventilation syndrome (OHS) and sleep-disordered breathing. Excluding those with coexisting sleep apnea may restrict access for clinically appropriate candidates.

3. Inclusion of Alternative Testing Modalities
We urge CMS to accept additional diagnostic and monitoring tools—such as venous blood gases (VBG), end-tidal CO2 (EtCO2), transcutaneous CO2 (TcCO2), and pulmonary function testing (PFT)—in lieu of or alongside arterial blood gases (ABG). These are widely used, less invasive, and clinically validated in identifying hypercapnia and monitoring therapy.

4. Removal of the Two-Week Waiting Period to Validate “Persistent Hypercapnia”
Delaying treatment to reassess hypercapnia after two weeks could put patients at risk. There is strong evidence supporting early initiation of NIV, which reduces mortality, hospital readmissions, and healthcare costs.

5. Elimination of Prescriptive Language Regarding Therapy Settings and Usage Requirements
Terms like “high intensity therapy,” specified pressures or respiratory rates, and minimum use thresholds are overly prescriptive and may interfere with individualized, physician-directed care. Clinical judgment should guide therapy decisions based on patient response and tolerance.

6. Removal of the Six-Month Reevaluation and Requalification Requirement
Frequent reevaluations place unnecessary burdens on both patients and providers. Chronic respiratory failure is, by nature, a long-term condition. Requalification adds administrative complexity and risks disrupting ongoing care.

7. Removal of FiO2 Requirements in the HMV Provision
The requirement to document a minimum fraction of inspired oxygen (FiO2) for qualification may exclude patients with hypercapnic conditions who do not require supplemental oxygen but still benefit from ventilatory support.

8. Grandfathering Existing Patients
It is critical that patients currently receiving NIV or HMV not be required to requalify under the new policy. Disruption of established therapy may lead to deterioration in health and increased utilization of emergency and inpatient care.

9. Inclusion of CMS’s Own Data Demonstrating Early NIV Benefits
Recent studies, including those derived from CMS’s own datasets, have shown that early use of NIV significantly improves health outcomes, reduces healthcare costs, lowers mortality, and prevents readmissions. We strongly urge CMS to incorporate this body of evidence in its final policy formulation.

10. Request for Delay in Final Implementation
Given the scope of the proposed changes, we respectfully request a delay in implementation. This time is necessary to allow providers to prepare, train clinical teams, educate patients, and update systems to ensure safe, effective adoption of the new policy.

In closing, we appreciate CMS’s efforts to enhance care delivery for patients requiring ventilatory support and ask that you consider these recommendations to create a policy that promotes access, safety, and clinical efficacy.

Thank you for your thoughtful consideration.

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Summary of Dobson DaVanzo & Associates, LLC Analysis of Non-Invasive Ventilator (NIV) at Home for Selected outcomes
Results for Healthcare Common Procedure Coding System (HCPCS) E0466 Only for Fee for Service (FFS) and Medicare Advantage (MA) Beneficiaries

Dobson DaVanzo & Associates, LLC (Dobson|DaVanzo) is a health economics and policy consulting firm based in the Washington, D.C. metropolitan area

Contact information:
(703) 260-1760
al.dobson@dobsondavanzo.com
www.dobsondavanzo.com

Impact of NIV (HCPCS E0466) Use on Utilization and Clinical Outcomes of Fee for Service (FFS) and Medicare Advantage (MA) Beneficiaries
Objectives

Dear CMS Decision-Making Committee,

I am writing to respectfully request that CMS incorporate a more comprehensive evaluation of recent and relevant studies—particularly those leveraging CMS’s own data—into the final National Coverage Determination (NCD) decision on Non-Invasive Ventilation (NIV). These studies consistently demonstrate that early initiation of NIV is associated with significant improvements in patient outcomes, including reduced mortality, fewer hospital readmissions, lowered overall healthcare costs, and improved patient health status.

Given the strength and consistency of these findings, especially when derived from CMS’s own datasets, we urge CMS to ensure that such data are included and appropriately weighted in the final policy-making process. Doing so will align the NCD with evidence-based best practices and reinforce CMS’s commitment to data-driven decisions that prioritize both quality and value in healthcare.

Additionally, we respectfully request a delay in the implementation timeline of the final NCD. A brief postponement would allow healthcare providers and organizations the necessary time to properly prepare, operationalize the new requirements, and conduct essential provider education. Ensuring clarity and readiness will facilitate a smoother transition, enhance compliance, and ultimately support the success of the policy in improving patient care.

We appreciate your dedication to improving the standards of care and ensuring access to life-saving therapies. Thank you for your attention to these important considerations.

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The Centers for Medicare & Medicaid Services (“CMS”) issued proposed coverage criteria for Home Mechanical Ventilators (“HMV”) based on an incomplete review of the scientific literature, drew conclusions not supported by the literature it did review, and created coverage criteria that are inconsistent, confusing, and opaque. Sleep Management, LLC d/b/a VieMed (“VieMed”) and its Chief Medical Officer, Dr. William Frazier [1], have extensive experience in providing respiratory care and technology-enabled home medical equipment services and are convinced implementation of the proposed HMV coverage criteria as a new National Coverage Determination (“NCD”) as written will result in:

1. Immediate Harm to Patients currently receiving life-saving respiratory support via HMV who will no longer qualify for HMV coverage and to future patients who will be denied access to the established benefits of HMV treatment;
2. Increase in Medicare Spending on treating patients with Chronic Respiratory Failure (“CRF”) consequent to Chronic Obstructive Pulmonary Disease (“COPD”) due to increased hospital admissions;
3. Unsupported “Tried and Failed” Step Therapy in one pathway to initial HMV coverage wherein patients must fail treatment with, or be unlikely to achieve certain clinical outcomes on, a lessor device like BPAP (“RAD”) before being allowed to use HMV. This approach is contrary to the FDA approvals and labeling for RAD use and contradicts the established standard of care; and
4. Significant Provider and Supplier Confusion in managing existing patient populations, coordinating care with treating practitioners, and evaluating and incorporating new HMV coverage criteria into existing workflows, policies, and procedures all attributed to the unclear coverage criteria and nonexistent guidance regarding implementation.

Background:

On March 11, 2025, the Coverage Analysis Group (“CAG”) of CMS released a proposed decision memo detailing the National Coverage Analysis (“NCA”) for Noninvasive Positive Pressure Ventilation (“NIPPV”) in the Home Treatment of CRF Consequent to COPD (CAG-00465N). This memo was released 6 months after a request for public comment regarding reconsideration of NCD 280.1 pertaining to ventilator use in CRF consequent to COPD. VieMed and Dr. Frazier submitted a detailed comment on October 10, 2024.

Fundamentally, CMS CAG proposes to initially cover HMV for patients with CRF consequent to COPD, only when an arterial blood gas (“ABG”) demonstrates a PaCO2 = 52 mmHg, hypercapnic CRF is not caused by sleep apnea, and if at least one of four additional criteria that attempt to account for situations where treatment via RAD would be inadequate are met: (1) concurrent oxygen therapy using FIO2 of 36% or 4 liters of O2; (2) ventilatory support for more than 8 hours per day is required; (3) need for alarms and internal battery due to inability to breath unassisted for more than a few hours; or (4) likely failure of RAD treatment based on failing to achieve certain clinical outcomes during an adequate trial period of RAD therapy. Separately, CMS proposes to initially cover HMV for patients immediately upon hospital discharge if their needs exceed the capabilities of a RAD and they required usage of a ventilator within the 24-hour period prior to discharge. In addition, HMV patients must re-qualify every six months, requiring re-evaluation by their treating practitioner and demonstrate average HMV use of at least 5 hours per 24-hour period.

These proposed coverage criteria at best ignore: (1) the clinical realities for patients with CRF consequent to COPD; (2) current medical literature based on CMS’s own data examining large samples of Medicare beneficiaries; (3) the clinical capabilities of RAD devices vs. HMV devices and the respiratory conditions they are approved to treat; and (4) the chaos and confusion that will ensue due to the lack of implementation guidance in the proposed decision memo. Ultimately, CMS’s proposed coverage criteria limits patient access to life saving HMV equipment, based on outdated and inconclusive medical literature, under the guise of cost savings at the expense of these chronically ill patients’ health.

VieMed has concerns with the proposed coverage criteria. First, and most importantly, curtailing patient access to HMV will result in worse patient outcomes, including increases in mortality, and higher health care costs. Second, CMS relies on a limited set of outdated non-representative randomized controlled trails (“RCTs”) to support the proposed coverage criteria. Third, the requirement for minimum use threshold is arbitrary and unsupported by clinical data. Fourth, defining persistent hypercapnia as PaCO2 = 52 mmHg is also arbitrary and not supported by clinical data. Fifth, the requirement that certain clinical outcomes not be achieved with RAD treatment amounts to imposition of a “tried and failed” step therapy requirement. Sixth, the requirement that providers rule out hypercapnia caused by sleep apnea is nonsensical and confusing. Seventh, coverage of HMV upon hospital discharge only if “the beneficiary’s needs exceed the capability of a RAD and [the beneficiary] required usage of [HMV] within the 24-hour period prior to hospital discharge to avoid rapid symptom exacerbation or rise in PaCO2” is not supported by clinical data or clinical realities. Eighth, CMS invites chaos and confusion in patient care if the proposed decision memo is published without clear implementation guidance and a lengthy implementation timeframe.

Concerns:

1. Imposition of Unsupported Coverage Criteria Will Result in Increased Mortality and Hospitalizations and Higher Health Care Costs.

Implementation of the proposed arbitrary, unsupported, and confusing HMV coverage criteria discussed herein will result in significant numbers of current patients using HMV to no longer qualify for coverage. It is unclear, based on the lack of any guidance related to implementation, whether CMS intends to grandfather in these patients for coverage purposes. The importance of using HMVs to provide NIPPV was shown by 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.[2] Conversely, an RCT done in the U.K. showed no improvement in mortality when hypercapnic COPD-CRF patients were treated with BPAPs/RADs, which is likely why the overwhelming majority of BPAPs/RADs are not FDA approved for treatment of hypercapnic respiratory failure consequent to COPD.[3] These current patients, and all future patients, will be relegated to equipment that cannot provide the same level of respiratory support resulting in worse patient outcomes, increases in hospital admissions, and higher health care costs.

2. Reliance on Outdated, Non-Representative RCTs in Support of the Proposed Coverage Criteria.

The CMS National Coverage Analysis Evidence Review Guidance Document of August 7, 2024, provides guidelines for CAG to use when assessing the literature being relied on to formulate an NCD. While this document recognizes the important role RCTs may play in assessing outcomes, it also recognizes their limitations:

“[P]ost-market observational studies can be more representative of actual clinical practice, both in terms of patient populations and how care is delivered . . . Newer study design approaches and analytic techniques that handle bias continue to evolve and may improve the reliability and validity of observational study results. [Fit- for-purpose] observational studies aim to emulate the strengths of RCTs by taking advantage of these newer approaches and techniques.”[4]

Despite these guidelines for choosing relevant literature to review, three (3) peer reviewed studies published in 2020, 2021, and 2022, on HMV use in 500,000 Medicare beneficiaries with COPD-CRF were ignored by CAG when preparing the memo. These studies are large, real-world observational claims data analyses describing data from 2012-2020 and used the advanced statistical methods referred to above.[5] All the data was gleaned from CMS’s own Research Identifiable File (RIF). The studies reported robust decreases in mortality and hospitalizations in hypercapnic COPD-CRF patients prescribed HMV compared to identical patients who were not. Hypercapnia was defined as any elevation of PaCO2 above normal and the largest clinical benefits were seen in patients who began HMV as soon as possible following a diagnosis of hypercapnic COPD-CRF. Additionally, the providers prescribing NIPPV for Medicare beneficiaries chose HMV 92% of the time, as opposed to the memo’s required first choice of a BPAP with backup rate feature, which providers chose just 1% of the time (BPAP without backup rate feature made up the other 7% of NIPPV prescriptions in these studies).[6]

Four (4) RCTs were given great weight in the memo. These small trials were conducted in Europe between 1996 and 2016 and enrolled a combined 602 patients, 303 in the NIPPV groups and 299 in the control groups.[7] Three (3) of the studies used BPAPs with backup rate (the memo’s required initial device) to provide NIPPV and none of these reported an improvement in mortality.[8] The fourth study did show decreased mortality in the NIPPV group, but the specific device supplied to each of the 102 patients was not specified, so it is unclear if or how often RADs or HMV were used.[9]

Additionally, only about 50% of the patients in these 4 studies averaged more than 5 hours per 24-hour period of NIPPV usage.[10] This is the metric proposed in the memo as a minimum requirement for a patient to qualify for continued NIPPV coverage.[11] Importantly, none of these studies reported a correlation between hours of use and clinical outcomes. [12]

The CMS National Coverage Analysis Evidence Review Guidance Document goes on to say:

“[E]ven well-designed and well-conducted trials may not supply evidence relevant for CMS if study results do not apply to the Medicare beneficiary population. . . . To the extent that health systems and practice standards differ between countries, an outside the U.S. study may not be generalizable to the Medicare beneficiary population.”[13]

Obviously, the four (4) small, outdated, European RCTs relied on in the proposed decision memo are much less likely to represent outcomes in Medicare beneficiaries than are the three analyses based solely on CMS’s own data about this population.

3. Requirement for Minimum Usage Threshold is Arbitrary and Not Supported by Clinical Data.

CAG confusingly proposes two different minimum usage requirements for HMV coverage. The first pathway through which patients can qualify for initial coverage is to need ventilatory support for more than 8 hours per 24-hour period. This requirement is arbitrary and not supported by the medical literature or by common sense. As an initial matter, it seems impossible for a patient to demonstrate the need for ventilatory support for more than 8 hours per day prior to beginning treatment. Patients use of HMV will go up and down based on need and comfort with the HMV. To suggest a patient or practitioner can know or predict the exact number of hours necessary for the patient to achieve clinical benefit prior to commencement of HMV therapy suggests a significant disconnect between CAG’s understanding of HMV therapy and the clinical reality for doctors and patients.

Second, as a requirement for coverage beyond 180 days, patients must show HMV use of at least 5 hours per 24-hour period. Any minimum average hours of use (whether 8 hours per day or 5 hours per day) for initial or continued HMV coverage is arbitrary and not supported by published outcomes data. Therefore, the NCD should not include a minimum use threshold for initial or continued HMV coverage. In the four (4) RCTs discussed above, which were heavily relied on by CAG in formulating this proposed decision memo, approximately half the patients used NIPPV less than 5 hours daily. None of these four (4) studies reported that any specific number of hours of HMV use correlated with improved outcomes.

Additionally, the Technical Expert Panel Reconsideration Request, which prompted this NCA, states that NIPPV use in clinical trials averages <4 hours/day in at least 30% of patients.[14] It is likely the “real world” usage is even less. Nonetheless, the published “real world” claims data, which does not report hours of use, shows robust clinical improvements when HMVs are used to treat hypercapnic CRF-COPD.[15] Given the high mortality and morbidity seen in hypercapnic COPD-CRF and the lack of data on how much HMV use is necessary to reduce these risks, the most prudent course is to continue HMV therapy in those patients who, in agreement with their providers, wish to do so regardless of their pattern of use, while simultaneously mandating interventions to maximize compliance with therapy.

Also, from a practical implementation standpoint, the continuing coverage requirement lacks clarity. In what period is this required 5-hour average to be calculated? Is it the last 30 days of the 180-day period, or the best 30 days, or the average of the entire 180 days? Additionally, CAG fails to consider how hospital inpatient stays will skew usage data. If a patient’s condition exacerbates, they may require inpatient treatment at the hospital. Obviously, during the inpatient stay they will not use the HMV device at home. These potentially extended hospital stays will lead to reduced usage of their HMV. Will CAG incorporate an exception to the usage requirements with documentation of an inpatient hospital stay? These details are crucial to understanding the impact of this proposal.

In short, the imposition of any minimum use standard, whether qualifying for initial coverage or continued coverage, will only restrict access of HMV treatment to patients in need of this lifesaving respiratory therapy, resulting in increased mortality and hospital admissions, as well as higher medical costs.

4. Arbitrary Definition of Persistent Hypercapnia as PaCO2 = 52 mmHg Measured by Arterial Blood Gas (ABG).

CAG’s choice to define persistent hypercapnia as PaCO2 > 52 is arbitrary. Current data suggests that the benefits of NIPPV in COPD-CRF patients are limited to those who have a confirmed diagnosis of chronic hypercapnia, defined as an elevation above the normal value 45 mm Hg. There is no data showing the precise level of PaCO2 elevation necessary to achieve benefits from NIPPV.[16] 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.[17] This is consistent with a 2020 meta-analysis of NIPPV use in hypercapnic COPD-CRF patients, published in JAMA and commissioned by CMS CAG, which similarly concluded that:

“There were no significant differences in mortality or all-cause hospitalization admissions based on PaCO2 threshold initiation criteria.”[18]

The four (4) RCTs of NIPPV use in COPD-CRF patients relied on by CAG when formulating this NCA, limited enrollment to those with PaCO2 levels >52 mm Hg. While this has led some experts to suggest that NIPPV should be limited to such patients,[19] 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 > 52 mm Hg is an investigational trial design artifact and cannot be used to conclude that only this group of hypercapnic COPD-CRF patients benefit from NIPPV. The current evidence suggests any level of chronic hypercapnia above 45 mm Hg is sufficient to predict clinical benefits of NIPPV for patients with COPD-CRF.

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.[20]

5. Requirement that Certain Clinical Outcomes are Not Achieved with RADs Prior to HMV Approval Amounts to a “Tried and Failed” Step Therapy Requirement.

One pathway to HMV coverage requires: “None of the below [positive clinical outcomes] are likely to be achieved with consistent use of a RAD with backup rate feature for 5 hours per 24-hour period during an adequate trial period because the patient’s inspiratory pressure needs exceed the capabilities of a RAD as justified by the patient’s medical condition.” This requirement suggests a “tried and failed” approach where a patient must first fail a treatment trial with RADs before being approved for HMV. Alternatively, is CAG suggesting the ordering practitioner must attest that RAD treatment is unlikely to result in the positive clinical outcomes? The answer is not clear.

What is clear is that no medical literature exists supporting this practice and there are not generally accepted, objective, clinical criteria for determining what constitutes a RAD failure, despite the list provided in the proposed decision memo. Additionally, if CAG’s intent is only to require an ordering practitioner’s clinical note or attestation, no guidance is provided on how to prospectively determine if a patient is unlikely to achieve the listed clinical outcomes without first undergoing RAD treatment—resulting in a de facto “tried and failed” step therapy requirement.

Recent studies not considered by CAG show mortality reductions occur only if HMV begins within the first 30-60 days following a hypercapnic COPD-CRF diagnosis.[21] HMV coverage should not be conditioned on patients failing with RADs since that therapy has not been shown to be as effective as HMV. Due to the rapid reduction in mortality and hospitalization risks when HMV is started in hypercapnic COPD-CFR, a requirement of “tried and failed” step therapy will delay patients from receiving the most appropriate care, which will in turn increase hospitalizations and deaths.

A policy requiring the delay of HMV initiation until a patient fails on RADs is without scientific or medical basis, exposes patients to potential harm, and exposes providers to potential malpractice liability.

6. Exclusion of Hypercapnia Caused by Sleep Apnea is Nonsensical and Confusing.

Obstructive Sleep Apnea (“OSA”), in the absence of co-existing Obesity Hypoventilation Syndrome, almost never causes hypercapnia, so this criterion is immaterial and should be removed. Regardless, CAG proposed this criterion with no thought to the implication of implementation. How are practitioners to determine if a patient has OSA? Will a sleep study be required or will exclusion of OSA on clinical grounds be sufficient? Is CAG suggesting a patient with OSA and hypercapnic COPD-CRF receive treatment for OSA before they can qualify for life-saving HMV treatment? Clarity is needed.

7. Coverage of HMV Upon Hospital Discharge Only if HMV was Used within the Last 24 Hours of Hospitalization is Not Supported by Clinical Data or Clinical Realities.

CAG proposes to cover HMV as initial therapy for patients upon discharge from the hospital only when their needs exceed that which a RAD can provide and if they used a ventilator within 24 hours of discharge. This proposal has no basis in the literature or in the way pulmonary medicine is routinely practiced. A metric often used to assess a patient’s readiness for safe hospital discharge is when they can be removed from NIPPV for 24 hours without experiencing dangerous decompensation. This in no way implies a patient does not need chronic NIPPV therapy, only that they have some margin for safety as they transition home.

Also, the way providers are required to prove a hospitalized patient’s “needs exceeded the capabilities of a RAD” are unclear. Is this another attempt by CMS at instituting “tried and failed” step therapy, this time in critically ill COPD-CRF patients? Or is CAG suggesting the ordering practitioner can simply attest that RAD treatment will be inadequate in this unstable population? The answer to this vital question is not clear.

Again, CAG’s proposal demonstrates a disconnect from the clinical realties of treating patients with CRF consequent to COPD.

8. CMS Invites Chaos and Confusion by Publishing its Proposed Decision Memo Without Clear Guidance Regarding Implementation.

VieMed, and all Medicare enrolled DME suppliers, are entitled to clear guidance on how CMS’s proposed HMV coverage criteria will be implemented. VieMed expends significant effort and cost to provide HMV equipment, supplies and services to patients that qualify for HMV coverage under the current NCD. Some portion of these patients will no longer qualify for coverage under the proposed standards. Will these existing patients be grandfathered in for coverage purposes? If not, at what time will these patients need to meet the new coverage criteria or have their HMV equipment removed? Because HMV is lifesaving equipment, there are significant logistical and ethical implications for removing equipment from a patient.

So far, CMS has provided no guidance on when the proposed coverage criteria will be implemented. Statutorily, it is possible that the proposed coverage criteria will become effective June 9, 2025, when the final decision memo is published. Historically, CMS has delayed implementation of the coverage requirements to give both suppliers and its Medicare Administrative Contractors time to develop necessary processes and procedures to meet the new coverage requirements. Will CMS delay implementation of the final NCD? The lack of implementation guidance in the proposed decision memo again suggests a lack of appreciation for the severity of these patients’ respiratory condition and the effort required to provide respiratory equipment and continuous service.

Recommendations:

VieMed and Dr. Frazier respectfully request CMS reconsider the proposed coverage criteria for HMV and adopt a more inclusive approach that considers the diverse needs of patients with hypercapnic CRF consequent to COPD. Previously, VieMed and Dr. Frazier submitted recommendations for scientifically supported, rational, clear HMV coverage criteria as follows:

1. Indicate NIPPV coverage for hypercapnic COPD-CRF patients who have an elevation of PaCO2 above the upper limit of normal—PaCO2 >45 mm Hg with appropriate pH compensation.
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 that once a patient is diagnosed, they are unlikely to improve enough to not need HMV treatment in the future. 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.

References:

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The biggest issue with the proposed policy is that there is no "grandfathering" for existing equipment. Existing patients must have a means to keep their current equipment.

The six month re-evaluation- This requirement is too burdensome on patients. This will cause increased barriers and will cause additional cost for the patients. Also obtaining another ABG every 6 months is also very burdensome.

Requirement of 5 hours per day- This requirement contradicts the current requirement on the PAP policy. There needs to be the same. A new guideline such as this will only create more barriers to care.

The requirement of being at greater than 31 also cannot be adopted in the policy. Patients have different needs and this is setting a much higher threshold. Some patients need a vent at a lower pressure with a different setting that cannot be accomplished with a BiPAP.

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On behalf of the American Association for Respiratory Care (AARC), thank you for accepting our comments on the proposed decision memo for Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) consequent to Chronic Obstructive Pulmonary Disease (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 (DME) 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 covered under the DME benefit.

The AARC is a national professional organization with a membership of over 44,000 respiratory therapists who treat patients with acute and chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. Through our advocacy, we support more than 125,000 practicing respiratory therapists across the country.

Respiratory therapists are an integral part of the healthcare system, providing care for patients with a myriad of pulmonary diseases, including chronic obstructive pulmonary disease (COPD), asthma, bronchitis, emphysema, cystic fibrosis, and acute respiratory distress syndrome. Our members also provide therapy for patients suffering from neuromuscular diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, and sleep apnea. Finally, respiratory therapists provide care for patients suffering from trauma and provide support for premature infants. Respiratory therapists treat patients of all ages, and they use their training in pulmonary medicine to provide therapeutic care to patients suffering from pulmonary disease and other conditions that impair breathing.

The AARC thanks the agency for adopting many of the recommendations outlined in our national coverage analysis comment letter. Additionally, the goal of the original NCD revision request submitted on September 9, 2021 was to enhance access to noninvasive ventilators for patients with chronic respiratory failure due to COPD and other conditions, ensuring Medicare beneficiaries receive optimal care, and we believe that this proposed decision memo achieves that goal. The final details of the proposed decision memo are particularly important to ensure access to respiratory care by respiratory therapists by addressing the clinical needs of patients suffering from respiratory failure. We are extremely thankful to the agency for developing an NCD that meets the needs of the patients that our members treat.

Throughout this process, the AARC has continually supported the use of arterial blood gas measurement as a criterion in determining the need for an NIPPV and eliminating the requirement for nocturnal oximetry tests. We are pleased to see that CMS has adopted the use of arterial blood gas measurement of PaCO2 = 52 mm Hg as a primary clinical criterion for coverage.

Additionally, it has been our position to use bi-level positive airway pressure (BPAP) device with backup rate as the starting respiratory therapy rather than BPAP without backup. Non-invasive ventilation with a backup rate significantly reduces mortality and hospitalizations in patients with chronic hypercapnic respiratory failure from COPD. The proposed decision memo supports this position by recommending the use of BPAP-ST (spontaneous/timed) and volume-assured pressure support options. We are also pleased to see that the agency believes that device selection should be based on the patient’s specific condition (COPD, thoracic restrictive disease, etc.) and supported by clinical evidence.

We strongly urge CMS to include a grandfather clause for existing Medicare beneficiaries already using Respiratory Assist Devices (RADs) or Home Mechanical Ventilators (HMVs). Forcing these patients to requalify under newly established criteria could disrupt continuity of care and lead to unnecessary hardship. A clear transition policy will preserve therapeutic gains already achieved and maintain patient safety.

We are concerned that the proposed 5-hour nightly usage requirement places an undue burden on patients, physicians, and suppliers. This exceeds current adherence expectations for other respiratory therapies (e.g., 4 hours/night for CPAP) and may create unnecessary barriers to coverage. We recommend aligning the requirement with standard clinical practice: 4 hours per day on at least 70% of days in a 30-day period, which strikes a balance between patient capability and therapeutic efficacy. This more practical threshold has precedent and reflects realistic patient behavior.

Finally, AARC continues to support the coverage of a second 90-day adherence trial period and are disappointed that CMS did not include this in the proposed decision memo. The coverage of a second 90-day adherence trial period would provide patients more time to demonstrate adherence and clinical improvement. Some Medicare patients may need a longer period to reach conventional adherence definitions, and coverage of a second 90-day period may be essential to reaching the required levels of adherence and more importantly to show clinical improvement. We ask that the agency reconsider and revise the decision memo to include coverage for a second 90-day trial period.

The AARC thanks the CMS for its work on the revision to NCD, and we support the agency in these efforts, and thank you for the continued collaboration. If you have questions or would like to meet to discuss our comments, please contact Miriam O’Day, Senior Vice President of Government Affairs, AARC (Miriam.oday@aarc.org).

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Thank you for the opportunity to give feedback to the proposed changes to RAD and NIV qualification and re-qualification process.

I am only in favor of what brings patients a better quality of life while they are entrusting all of us with their care. I have a single question. Who is going to be liable when a patient is unable to qualify/re-qualify for (RAD) Respiratory Assist Device or (NIV) Non-Invasive Ventilator when the patient is unable (for whatever reason) to have an ABG obtained or doesn't meet the mandated 5 hours per day usage? If said patient has a negative outcome (i.e. death) because patient is unable to meet the rigorous rules and repeated qualification processes, who is going to be held ultimately responsible? It seems to me that having a physician or APP document that their patient has a diagnosis and what the prescribed treatment should be enough to qualify said patient for RAD and NIV. It has already been said, but I want to reiterate that a VBG is much less painful, and it will provide essentially the same CO2 as an ABG. Why make the process more difficult for patients who have to navigate the current process just to breathe? I am the one often calling the patient letting them know their DME provider has reached out to let them know that even though they have gone through the process, their claim has been denied. I want to be able to direct them to a person or phone number that someone will actually answer and know the answer to questions without reading a script.

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Thank you for the opportunity to submit comments and thoughts on the draft NCD.

After careful review and much discussion, I am respectfully writing to voice strong opposition to aspects of a draft National Coverage Determination (NCD) concerning Respiratory Assist Devices (RAD) and Home Mechanical Ventilation (HMV) therapies. The core arguments center around the potential negative impacts on current and future patients and the practicality of the proposed requirements.

Here's a breakdown of the key concerns:

Barnes Healthcare Services Official Comment on the Proposed NCD for NIPPV

Barnes Healthcare Services, a fourth-generation, family-owned provider serving patients throughout the Southeast for over a century, appreciates the opportunity to provide comment on the proposed National Coverage Determination (NCD) regarding noninvasive positive pressure ventilation (NIPPV).

While we understand and support CMS’s intent to ensure appropriate utilization and accurate qualification of patients, we are deeply concerned about the far-reaching and potentially devastating consequences of the proposed policy as currently written. Our comments reflect the real-world challenges faced by patients, caregivers, and providers—particularly in rural and under served communities—and emphasize the need for a thoughtful, phased-in, and non-burdensome approach that prioritizes patient outcomes and sustains our nation’s respiratory care infrastructure.

1. Patient Access and Grandfathering Provisions

The proposed NCD appears to overlook the critical importance of ensuring continuity of care for patients already on therapy. These patients, many of whom have benefited from this therapy for years, often lack the retrospective documentation now required. Removing these devices due to new qualification criteria poses serious risks, including hospitalization, rapid health deterioration, or even death. There must be a clear grandfathering provision to protect existing patients and avoid disrupting essential care if these new rules were to take effect.

2. Burden on Patients and Physicians

The increased administrative and clinical burdens—such as six-month re-evaluations and mandatory arterial blood gas (ABG) testing—are not only impractical but also counterproductive. In our experience, these requirements will disproportionately affect chronically ill, homebound, and rural patients, who already face challenges accessing their physicians. Many will simply be unable to meet these new standards, leading to loss of therapy and negative health outcomes up to and including loss of life.

Additionally, requiring repeat ABGs rather than allowing clinically appropriate alternatives like venous blood gas (VBG) or end-tidal CO2 (ETCO2) testing reflects an outdated and unnecessarily invasive approach. This not only places unnecessary strain on patients but also adds cost and complexity to the care process.

3. Adherence Thresholds Not Aligned with Standards
The proposed requirement for patients to utilize therapy on average for 5 hours per day diverges from longstanding adherence benchmarks. The industry standard defines adherence as =4 hours per night on 70% of nights in a 30-day window within the first 90 days of therapy. Deviating from this proven model undermines patient and provider confidence and will likely increase non-compliance due to unrealistic and unproven thresholds.

4. Impact on Infrastructure and Sustainability
The proposed NCD would upend a product and policy structure that has been in place for more than 15 years. The sudden overhaul threatens the sustainability of DME suppliers, particularly those like Barnes who serve high-needs, rural populations. Rather than destabilizing this infrastructure, we urge CMS to invest in and strengthen it. Any policy shift must be implemented gradually, with support for providers and physicians, and must not jeopardize the availability of care for vulnerable patients.

The proposed NCD, as currently written, risks dismantling critical respiratory care infrastructure across the country. Providers are already navigating workforce shortages, reimbursement constraints, and growing demand. We cannot absorb additional regulatory burdens that are divorced from patient realities without severe consequences to access and outcomes.

Conclusion

We respectfully urge CMS to reconsider the current proposal in favor of a more patient-centered, practical, and collaborative path forward. Policy improvements should be phased in over time and developed in partnership with stakeholders who have firsthand knowledge of patient care delivery.
Let’s not trade progress for policy. We are committed to advancing better outcomes and sustainable models of care, but that future must be built in partnership with the providers and patients whose lives and care depend on the appropriate, sustainable use of this therapy.

Thank you for the opportunity to comment.

Charlie Barnes
CEO
Barnes Healthcare Services

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During recent weeks I have read many well written pleas from physicians and clinicians to allow the provision of respiratory support for COPD in the home setting to be determined by the physician with input from clinicians. First and foremost, it must be understood by all involved decision makers that COPD is a TERMINAL DIAGNOSIS. COPD does not get better BUT improved quality of life and life span can be obtained if key factors are recognized and correct therapy is provided.

Rather than add to the Sa)2s, PaCO2s, ABG, BIPAP, HMV, CPAP jardon I choose to speak from the heart.

1) Grandfathering of existing home NIV patients is a must. A dear, long-time patient of mine passed away earlier this week. Several hours after hearing of his death from his emotional wife who voiced her appreciation of all the time spent with them and the support which was provided my thoughts turned to a sense of relief. Relief that I would not be having a conversation with him should the current proposed guidelines take effect. How sad that thought came to my mind. What kind of people are we becoming if a compliant (+8 years) patient will be told, "sorry but you gotta jump through hoops if there is any hope for you to keep the machine that you swear is what keeps you alive". Really, is that who/what we want to be? Have we no compassion? I challenge those making the decisions to grab a straw and place it in your mouth, pinch your nose and keep your lips sealed around the straw. The only way for you to breathe is through the straw. In and out, in and out, in and out. Take a stroll around the block while breathing this way. See how you feel. Imagine if you did this all day long, all night long every day of the week yet you no longer "qualify" for equipment that has helped you and it is suddenly taken away from you. Then go and get yourself an ABG. One of those will probably be enough.

2) Re-imbursement for the time RT's spend in the home should be considered. Having worked in a rehab setting for many years, I gained a deep respect for PTs and OTs and learned a lot from them. And I believe they would tell you it was a two way street. Why is their time reimbursed yet that of a RT is not recognized? It should not be assumed that PTs, OTs and nurses can address the respiratory needs of patients. I can teach someone how to use a transfer bench and how to perform ADLs but that is not within the scope of my practice just as technical respiratory is not within the realm of the forementioned practice grouops. RTs provice 24 hour support for home patients 7 days a week and 365(6) days per year. I have not heard of PTs and OTs rolling out of their warm bed to handle a call from a patient during the middle of the night or on Christmas Day. During recent disasters RTs rose to the occasion verifying patients were okay and walked them through the situation at hand. I do very much respect PTs, OTs and nurses and believe RTs should also be recognized for the value they bring to the table and re-imbursement should be implemented for RTs. What better time to do this as any changes will have a very large impact on RTs.

3) Please delay and reconsider the issues at hand with the current proposal. Listen to what people wiht far more intelligence and better technical speaking skills (than I have) have to say. Listen to those who "walk the walk". Time is on your side to postpone and re-evaluate before making a final decision. COPD patients with NIV needs will have their remaining time on this earth become more difficult if not deadly if the current guidelines become a reality. Certainly there is always room for improvement in what we do but let's not short change COPD patients, particularly those already using NIVs in the home. Please invite people to speak with you face to face so a better understanding of NIVs in the home setting is understood. I truly do no want to take a NIV out of a patient's home and tell him/her they don't have the numbers to justify the NIV when the reason they don't have the numbers is because the NIV is doing what it is designed to do. I cringe at the thought of shrugging my shoulders when they ask for help and all I can tell them to do is call a family member to take them to the ER. And to tell them to be sure to tell the driver of the car to quickly hit speeds fo 150mph so they can hand their head out the window in order to breathe. Hopefully they will make it to the ER alive.

4) I have seen many changes during my 52 years of working in respiratory therapy. Some good, some bad. I firmly believe the proposed guidelines and timeframes are in the bad category. Bad for the patients, doctors, ERs, hospitals and RTs. I respectfully ask for a delay while guidelines and timeframes are re-evaluated and ask that current home NIV patients continue to be home NIV patients and are grandfathered and allowed to continue their current therapy.

Thank you for your time and attention, I truly hope you and none of your family members are ever diagnosed with COPD. But if you are, I truly hope you have a caring and dedicated RT to help you.

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Policy Comment on Proposed Changes to RAD/NIV Coverage Criteria
Thank you for the opportunity to provide feedback on the proposed policy changes related to the coverage of Respiratory Assist Devices (RADs) and Non-Invasive Ventilation (NIV). We appreciate CMS’s efforts to ensure appropriate access to medically necessary therapy; however, we have significant concerns about several elements of the proposed policy, as outlined below:
1. Six-Month Reevaluation and Repeat ABG Requirement:
The proposed requirement for reevaluation, including a repeat Arterial Blood Gas (ABG) test every six months, introduces an undue administrative burden on patients, prescribers and HME suppliers. For Instance, suppliers dispense equipment based on a physician’s order but are held accountable for ongoing equipment maintenance and compliance until the patient obtains new test results and reviews them with their physician. This process may take days to months, during which therapy may be disrupted. CMS has established precedent in other policies (e.g., oxygen therapy) for continued coverage based on “continued use” and “continued need” without the necessity for repeat testing. We urge CMS to adopt the same standard here.
2. Invasive ABG Testing Every Six Months:
Requiring patients to undergo an invasive ABG test every six months is not only unnecessary but potentially harmful. Less invasive and clinically appropriate alternatives, such as Venous Blood Gas (VBG) analysis or End-Tidal CO2 (ETCO2) monitoring, are widely used and should be acceptable for ongoing assessment. For many patients, ABGs are painful, logistically difficult to obtain, and provide limited additional clinical value compared to these alternatives.
3. Proposed 5-Hour Daily Therapy Use Threshold:
The proposal to require an average of five hours of daily therapy use is more restrictive than current RAD policy. While clinical studies referenced in the National Coverage Analysis (NCA) report average patient use of five hours, there is no evidence to suggest that five hours offers greater clinical benefit compared to four hours. CMS should avoid setting arbitrary thresholds without demonstrated clinical value, and instead allow for continued use criteria consistent with current RAD policy.
4. Mandated Use of High-Intensity Modes:
The proposed requirement favoring high-intensity modes of therapy interferes with clinical judgment and may adversely affect patients who cannot tolerate these settings. Therapy modes should be selected based on individualized patient assessment, and physicians should retain the discretion to prescribe the most appropriate modality without undue restrictions.
5. Grandfathering of Current Patients:
The proposed policy does not address whether patients already receiving therapy under current guidelines will be grandfathered or required to requalify under the new criteria. It would be inappropriate and disruptive to require patients to requalify—regardless of whether they have been on therapy for one month or ten. These individuals initiated therapy in compliance with existing guidelines and under the supervision of their prescribers. We recommend that any new requirements apply prospectively and that existing patients be grandfathered based on their initial date of setup.
Conclusion:
We respectfully request that CMS reconsider the above provisions in the interest of patient safety, clinical appropriateness, and administrative feasibility. We support policies that are evidence-based, patient-centered, and allow for flexibility in clinical decision-making. Thank you for considering these comments as part of the policy development process.
Sincerely,
Melissa Cross

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LIMITS OF CMS’s RAD EVIDENCE

Köhnlein et al. (2014): Found a survival benefit (12% vs. 33%) using high-intensity NIV (mean IPAP 21.6 cm H2O). But the devices used were more consistent with U.S. HMVs, not RADs. Care was hospital-initiated and followed by structured home RT visits funded by Germany’s SHI. These conditions do not exist under Medicare.

Murphy et al. (2017): Showed reduced readmissions—but again, in an NHS system with robust follow-up and integrated homecare support.

Struik et al. (2014): Tested the same =52 mmHg PaCO2 threshold CMS now proposes—but found no difference in time to readmission or death (p = 0.85), despite Dutch homecare support. This suggests 52 mmHg may be too late for meaningful intervention.

These studies included HMVs, not just RADs, and focused on patients with severe hypercapnia. They largely excluded moderate cases. Tolerability was also an issue—high-intensity NIV (IPAP > 20 cm H2O) resulted in a ~20% dropout rate in some cohorts [6].

Notably, other studies, including Wilson et al. (2020) and Raveling et al. (2021), found benefits beginning at PaCO2 =45 mmHg—particularly when therapy was sustained and paired with clinical oversight. Similar findings were reported by Oscroft et al., who demonstrated that long-term NIV in COPD patients with persistent hypercapnia can improve outcomes when tailored to patient needs [10].

A EUROPEAN RECIPE IN AN AMERICAN KITCHEN

CMS’s clinical foundation draws heavily from European trials—Köhnlein et al. (2014), Murphy et al. (2017), and Struik et al. (2014)—each conducted within health systems that deliver hospital-initiated NIV supported by robust homecare services and publicly funded RTs through the SHI (Germany), NHS (UK), or Dutch thuiszorg (Netherlands) [1]. These studies combined RADs and HMVs under structured, RT-led follow-up.

By contrast, the U.S. Medicare system lacks this infrastructure. RADs (E0470/E0471) are reimbursed only through a capped rental ending at month 13, with no provision for RT support. HMVs (E0466, FSS) offer a bundled pathway that includes essential clinical oversight. The proposed RAD-centric framework assumes tools Medicare does not supply. HMVs often bridge this equity gap.

CAPPED RENTAL LIMITATIONS

Beyond lacking clinical support, RADs are constrained by a capped rental structure that does not accommodate the relapsing nature of chronic respiratory failure. Reimbursement drops by 25% after three months and ends at month 13, regardless of whether the patient discontinues and later restarts therapy. When patients attempt to reinitiate care (e.g., SNF admission), suppliers inherit the remaining months with no opportunity to reset. This makes continuity difficult, particularly for patients needing to change suppliers or re-enter therapy after a setback.

POLICY MISALIGNMENT: RADs, FSS, AND CLINICAL NEED

RADs were originally covered under Medicare for stable conditions like obstructive sleep apnea, patients who required minimal adjustment, and limited clinical oversight. The proposed policy removes OSA and shifts RADs toward a far sicker population, while still treating them as capped rentals. In contrast, HMVs are classified under Medicare’s own “Frequent and Substantial Service” (FSS) category, recognizing the need for sustained, hands-on support. CMS is now blurring that line, expanding RAD use while stripping it of its original purpose, and sidelining the only category (HMV + FSS) built to support patients with complex respiratory failure. Access to ventilation cannot be delayed. This bundled HMV model aligns with the care pathways described in the European studies CMS references.

TWO-WEEK DELAY CONCERNS

The proposed two-week delay before initiating home NIV is not supported by strong evidence. The trial behind it (Struik 2014) failed its primary endpoint, yet its protocol has been adopted as policy. For fragile COPD patients recovering from acute respiratory failure, delaying treatment can increase the risk of readmission or worse. Rather than imposing a fixed wait, CMS should allow clinicians to initiate therapy when medically appropriate.

RECOMMENDATIONS

1. Lower the PaCO2 threshold to =45 mmHg and allow use of TcCO2 or ETCO2 in place of ABG when appropriate.

2. Permit direct access to HMVs—without RAD trial—for patients with frequent exacerbations or severe CRF, especially when prescribed settings include IPAP 15–20 cm H2O, a backup rate, and sustained daily use.

3. Where RT funding is unavailable, allow bundled support through DME (E0466 + FSS) or defer to physician/RT discretion.

4. Grandfather current users to prevent care disruptions.

5. Implement changes over 12 months to ensure clinicians—particularly those serving underserved or high-need populations—have equitable opportunity to align care models.

FINAL THOUGHTS

CMS’s proposed approach places undue weight on studies conducted in different systems, using different tools, under conditions Medicare does not support. The current evidence does not justify a RAD-first, capped-rental pathway as the default. For many patients, HMVs represent the only viable way to deliver effective long-term NIPPV within Medicare’s constraints.

While CMS frames this policy as an expansion of access, the result may be the opposite: limiting access to sustained, effective therapy for the sickest and most vulnerable patients—those without private coverage, therapist support, or clinical flexibility.

Equity is not achieved by offering incomplete care pathways to all—it’s achieved by aligning coverage with real-world needs.

BIBLIOGRAPHY

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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. As a leading manufacturer of innovative NIPPV devices including Respiratory Assist Devices (RADs) and Home Mechanical Ventilators (HMVs), Resmed respectfully provides our insights and recommendations in response to this request for comment on the proposed decision memo.

As a pioneer in digital innovation, Resmed develops transformative solutions that not only improve care but also help keep people out of the hospital – empowering them to live healthier, higher-quality lives in the comfort of their own homes. We are focused on sleep and related chronic respiratory care, both of which we believe are globally underrepresented therapeutic areas, 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 respiratory diseases.

Resmed acknowledges and appreciates the immense efforts made by CMS to advance patient care and improve access for individuals with respiratory failure consequent to COPD ensuring patients have access to technologies which ensure optimal patient care. We appreciate CMS’ publication of a highly responsive and evidence-based proposed National Coverage Decision (NCD) regarding the use of RADs, including the removal of requirements for nocturnal oximetry study and sleep study to rule out OSA as the cause of hypercapnia from the National Coverage Analysis (NCA). Additionally, we agree with the proposed NCD’s mission of providing synchronous care to address different forms of noninvasive positive pressure ventilation (NIPPV), including both HMV and RADs, for the treatment of chronic respiratory failure consequent to COPD, in the home.

While we agree overall with the language in the proposed NCD with respect to RAD and HMV coverage criteria, Resmed respectfully suggests some critical primary changes necessary to ensure appropriate implementation of the NCD as well as secondary recommendations that can strengthen patient access to these devices while affirming the highest degree of program integrity.

We appreciate that CMS is receiving comments for making appropriate modifications in the best interest of advancing patient care and value the opportunity to submit this comment letter on the proposed NCD.

Critical Priorities: Device Mode Criteria, Hourly Usage Compliance, and NCD Implementation
Resmed believes the following recommendations given are of the utmost importance for the safety and care of all patients as they speak to the practical implementation of the proposed coverage policy.

Device Mode Criteria
Although Resmed understands and appreciates the intent to differentiate the types of devices used for noninvasive ventilation, physicians must have the flexibility to determine the appropriate pressures and modes of ventilation for each patient based on that patient’s clinical profile. We are concerned about the use of volume-targeted ventilation modes being a condition of coverage.

The American Academy of Sleep Medicine (AASM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo for “Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N).”

The AASM is the only professional organization dedicated exclusively to the medical subspecialty of sleep medicine with a combined membership of more than 11,000 accredited sleep centers and individual members. Many of our accredited 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 on the proposed decision memo.

The AASM appreciates that CMS has proposed an updated national coverage analysis (NCA) and revisions to the National Coverage Determination (NCD) based on the reconsideration request submitted by the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel (ONMAP TEP) and jointly supported by the AASM, American Thoracic Society (ATS), the American College of Chest Physicians (CHEST), the American Academy of Respiratory Care (AARC).

The AASM applauds CMS for the efforts that have contributed to this proposed NCA/NCD and the opportunity to advance evidence-based treatment that will lead to optimized outcomes in the management of chronic respiratory failure due to COPD.

Specifically, the AASM strongly supports CMS including the following proposed updates to the NCD, which modernizes the NCD to align with the current evidence and most recent clinical guidelines:

I definitely have some concerns regarding the recently proposed changes to coverage criteria, particularly as they relate to respiratory assist devices (RADs) and non-invasive ventilation (NIV). The modifications appear to have been implemented hastily and without adequate consultation or input from stakeholders within the home care industry.

Notably, several of the studies cited to support these changes are outdated and do not reflect the significant advancements in home ventilation technology or its proven role in reducing unnecessary hospital readmissions. The current evidence base fails to capture the real-world, patient-centered benefits that home ventilation provides in a post-acute care setting.

Two issues in particular raise concern:

RAD Device Compliance – While the changes appear to simplify initial qualification for RADs, they simultaneously impose stricter compliance and usage requirements. These requirements may be unrealistic for many patients and do not reflect individual clinical circumstances, potentially disqualifying patients who could benefit from continued therapy.

Barriers to NIV Access – The proposed reliance on biannual arterial blood gas (ABG) testing as a condition for continued NIV coverage is burdensome and potentially exclusionary, especially for patients with limited access to labs or transportation. Similarly, rigid adherence thresholds may penalize patients with complex conditions who cannot always meet usage expectations despite clear clinical need.

These changes should be evaluated through the lens of post-acute care and real-world outcomes. A patient-centered approach is critical—one that values clinical judgement, supports care in the home setting, and aligns with the goal of reducing hospital utilization and improving quality of life.

I strongly urge CMS to reconsider the proposal and meaningfully engage with providers, respiratory therapists, and patients before finalizing these policies.

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Patients with Chronic Respiratory Failure (CRF) due to advanced COPD often suffer from persistent hypercapnia, hypoventilation, and recurrent hospitalizations. Home mechanical ventilation, such as non-invasive ventilation (NIV) (e.g., BiPAP with backup rate), is not just a convenience—it is medically necessary and often life-extending.

Here’s why more restrictive CMS criteria would be harmful:

1. Clinical Benefit is Proven

Multiple studies, including randomized controlled trials, show that NIV reduces CO2 levels, improves quality of life, reduces hospital readmissions, and can extend survival in COPD patients with chronic hypercapnic respiratory failure.

2. Delaying NIV Increases Costs

Without access to home ventilation, these patients often return to the hospital with exacerbations, ICU stays, and frequent ED visits—which are far more costly to CMS than providing NIV at home.

3. Current Criteria Are Already Stringent

To qualify for home ventilation under current CMS policy, patients must:

Have documented hypercapnia (PaCO2 > 52 mmHg) in a stable state;

Often fail less invasive therapies like CPAP or oxygen alone;

Undergo significant testing and monitoring.

Tightening these rules further may delay or deny necessary therapy, even in clearly appropriate cases.

4. Patient Safety and Autonomy

Home ventilation helps keep patients in their homes, more independent, and engaged in their care. Reducing access pushes patients toward more institutional care or preventable deterioration, which undermines their quality of life and safety.

5. Equity and Access

Many patients—especially in rural or underserved areas—already face barriers to pulmonary care. Adding more layers to the approval process would widen the care gap and disproportionately affect vulnerable populations.

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We support all efforts to make healthcare more accessible and patient-centered, and we commend those involved in revising the National Coverage Determination (NCD) for Non-Invasive Positive Pressure Ventilation (NIPPV) for patients with COPD. We appreciate the proposed reduction in the burden of overnight polysomnography and the easing of documentation requirements.

However, the current proposed guidelines may introduce new, more significant barriers—such as the requirement for arterial blood gases and re-evaluation for re-qualification. These measures impose an unreasonable burden, particularly given the well-documented progression of disease in the affected patient populations. Such barriers disproportionately impact patients in rural areas and those with lower socio-economic status, potentially resulting in worse health outcomes, increased hospitalizations, and higher overall costs.

Policy should aim to eliminate unnecessary barriers, enabling patients to access care early in the course of their illness, which leads to better outcomes and more seamless care for the most critically ill. Drawing from lessons learned during the COVID-19 pandemic, policymakers should explore how technology can be leveraged to reduce administrative burdens. Robust clinical programs that incorporate remote patient monitoring and reliable data transmission from home devices are essential to supporting informed, timely care decisions. The integrity of healthcare hinges on the unwavering prioritization of patient access and care.

Thank you for the opportunity to contribute to this important discussion.

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I have 32 years of experience dealing with the COPD population in the post acute setting and because of My experience I am requesting the following.
-Removal of the requirement for PaCO2 = 52 mmHg
-Clarification or removal of the language stating “sleep apnea is not the predominant cause of the hypercapnia”
-Inclusion of alternative testing methods (e.g., VBG, EtCO2, TcCO2, and PFT) for qualifying and monitoring therapy
-Removal of the two-week waiting period to validate “persistent hypercapnia” before initiating services or treatment
-Removal of prescriptive language such as “high intensity therapy,” specific pressure or breath rate requirements, and minimum use requirements
-Removal of the six-month reevaluation period and requalification language
-Removal of FiO2 requirements under the HMV provision section
-Request that existing patients receiving these services are “grandfathered” and not required to requalify or limit access to service
Our ability to continue providing NIV for the COPD population is limited with this new policy which is bad for patients and bad for the industry

Thank you for your attention to this matter,
Gabriel Temblador RCP

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I would like to address several key points concerning the proposed changes, with the aim of ensuring both clarity and optimal patient care. Specifically, I would like to address: the removal of the PaCO2 = 52 mmHg requirement, clarification or removal of language stating that “sleep apnea is not the predominant cause of the hypercapnia,” the inclusion of alternative testing methods (e.g., VBG, EtCO2, TcCO2, and PFT) for qualifying and monitoring therapy, the removal of the two-week waiting period to validate “persistent hypercapnia” before initiating services or treatment, the removal of prescriptive language such as “high intensity therapy,” specific pressure or breath rate requirements, and minimum use requirements, the removal of the six-month reevaluation period and requalification language, and the removal of FiO2 requirements under the HMV provision section.

In addition, it would be greatly appreciated if existing patients receiving these services are “grandfathered” and not required to requalify or limit access to service. I also ask that more current studies that highlight CMS's own data in their final decision be included and considered. CMS data indicates NIV reduces cost, mortality, readmissions, and improves overall health when initiated at the early onset. Finally, I would like to request that the implementation be delayed to allow for proper preparation and provider education on the final NCD.

Your consideration of these requests is greatly appreciated.

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On behalf of the American Thoracic Society (ATS), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N).

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 in pulmonary, critical care and sleep medicine. In short, we are lung experts. As lung experts, we have considerable experience with the appropriate use of non-invasive ventilators and other respiratory assistive devices. Based on that expertise, we offer the following comments.

ATS supported this reconsideration request and we would like to thank CMS for the efforts that have contributed to this national coverage analysis and the opportunity to advance evidence-based treatment. ATS applauds CMS for developing essential improvements that will lead to optimized outcomes in the management of Chronic Obstructive Pulmonary Disease (COPD).

Please allow us to express our thanks for suggesting the following updates to the NCD, which we agree with:

ATS requests that CMS consider the following changes that we feel are critical to ensuring patient access to care and optimizing outcomes. Please note that our comments are in strong agreement with those of our sister organizations the American College of Chest Physicians (CHEST) and the American Academy of Sleep Medicine (AASM). In some sections, we provide additional justification.

Initial Coverage Criteria

Eliminate high intensity mode requirement – The recommendation for high intensity ventilation in the American Thoracic Society Guidelines is a conditional recommendation with low certainty evidence (cite). A conditional recommendation indicates there is uncertainty in the benefits and that different patients may require varying approaches. As noted in the guidelines, there is no clear definition of “high intensity” ventilation. Patients often need time to acclimatize to higher intensity settings with progressive adjustments, as was seen in the studies cited in the decision memo (Kohnlein, et al 2014, Murphy et al 2017, Coleman et al 2019). A requirement to initiate patients at these high intensity settings will negatively impact patient tolerance and adherence with the device. A logical outcome of the proposed language is that providers will order high settings, which will for the most part need to be adjusted lower almost immediately. We would suggest eliminating this requirement for RAD initiation and to instead consider settings at the re-evaluation at 180 days after initiation.

At 180 days, based on the prior literature, we would suggest an IPAP = 15 cmH2O with a backup rate of 14 bpm based on the cited 2014 meta-analysis (Struik et al 2014). These suggested settings also come from the pivotal Kohnlein study in which the mean inspiratory pressure was 21.6 +/- 4.6 cm of water and the backup rate was 16.1 +/- 3.6 (range 2-24) breaths per minute.

Define consistent use – We suggest consistent use in the continuing usage criteria for a RAD or HMV be defined as use of the device for an average of at least 4 hours per day on 70% of days within a 30-day period. Requiring 5 hours of usage every night for patients will be overly burdensome and is impractical. Patients may not have 100% daily usage for various reasons including acute illness or hospitalization. For example, more than 25% of patients had less than 4 hours of nightly usage at 6 and 12 months in the Murphy study. We believe a criterion of 4 hours per day on 70% of days within a 30-day period will streamline implementation given it is a logical extension of current practice.

In preparing these comments we also communicated with Professors Murphy and Hart, who kindly re-analyzed their data to assess the impact of adherence on outcomes using a more traditional 4 hours per day on 70% of days. Using this cutoff, there was still a statistically significant and clinically meaningful difference in time to first event (see Figure below, RED adherence >4 hours per night, 70% of nights, BLUE less than this threshold). These data provide a strong scientific rationale for the more traditional definition of adherence.

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Eliminate re-evaluation every 6 months for RAD and increase re-evaluation to every 12 months for HMV – While we agree with the recommendation for re-evaluation by day 180, we believe that requiring subsequent evaluation every 6 months thereafter is overly burdensome to patients and would worsen patient access to evidence based care. COPD is a chronic progressive disease and so the need for ventilatory support will not resolve in the absence of lung transplantation. For RAD therapy, the costs of ongoing coverage are minimal after 12 months and so the burden and costs of re-evaluation are greater than any potential cost savings. There does not appear to be any citable evidence to support the need for re-evaluation every 6 months beyond the initial 180 days. We would propose eliminating the need for an evaluation every 6 months for patients treated with a RAD device. For those with an HMV, we would propose every 12 months as a more reasonable alternative.

Additionally, we urge CMS to consider the following comments to further strengthen and align the proposed decision memo with evidence-based treatment to improve patient outcomes and reduce barriers to implementation:

We also suggest the addition of “sleep quality” as one of the patient symptoms associated with chronic hypercapnia that can improve as a result of either Bilevel PAP with BUR use or HMV use. (References: PMID 19672655; 25171686.)

Update sleep apnea criteria – We suggest a change in the language of the criteria regarding sleep apnea, where the treating clinician can determine sleep apnea is not the predominant cause of hypercapnia without having to perform sleep testing. This would be an extension of current practice based on the current NCD: “Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from sleep apnea.)”

Redefine stable COPD – We suggest a change in how stable COPD is defined. Requiring a 4-week period without change in pharmacologic management will be burdensome to the patient and could delay evidence-based care. Patients requiring a RAD for chronic respiratory failure in COPD might require more frequent changes to their medication regimen to achieve better symptom control. We feel that a 2-week period without a change in pharmacologic management is more reflective of clinical practice and will be less burdensome to patients.

Eliminate requirement for specific HMV mode – We suggest against the requirement of a specific volume targeted mode as HMV modes continue to evolve and there is a need to have a durable NCD for the foreseeable future. We believe the HMV should be used with the intent of providing high intensity therapy, which might be accomplished with a variety of modes.

Do not apply revised NCD to existing patients – We suggest that these revised NCD not apply to patients who already have a bilevel device with backup rate capability or a HMV. Ongoing adherent use of a device may make it difficult to meet the initial coverage conditions unless they stop a successful therapy.

Finally we suggest adding language to simplify documentation and reduce variability in interpretation, where possible, in the final NCD. As an example, we suggest removing the criterion for RAD and HMV use that: “The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist.” While we understand CMS intent with this language, we believe the burden on clinicians to consistently document physical and cognitive ability of the patient and/or caregiver will be high and inconsistent. Clinicians inherently assess the capability of the patient and their support structure to implement NIV. Furthermore, we are unaware that such language has been used in current and prior NCDs. Similarly, we suggest that, throughout the NCD, patient stability, potential for deterioration, etc., be determined and documented by the treating clinician.

To complement our comments above, we have also submitted (to the CAG Inquiries mailbox) a draft NCD with line-item changes. We do this in hopes that it may clarify our recommended changes and facilitate the creation of the final NCD for CMS officials.

ATS is confident that the adoption of these comments will advance evidence-based treatment and optimize outcomes in the management of COPD. We thank CMS for taking ATS's comments into consideration.

Sincerely,

Robert L. Owens MD, ATSF
Chair, ATS Sleep Respiratory and Neurobiology Assembly

Irina Petrache MD, ATSF
President, American Thoracic Society

Coleman JM, et al. Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019 Sep;16(9):1091-1098.
Emelie Ekkernkamp, Jan H Storre, Wolfram Windisch, Michael Dreher. Impact of intelligent volume-assured pressure support on sleep quality in stable hypercapnic chronic obstructive pulmonary disease patients: a randomized, crossover study. Respiration. 2014;88(4):270-6. doi: 10.1159/000364946. Epub 2014 Aug 22. PMID: 25171686
Ernesto Crisafulli 1, Giuseppe Manni, Marika Kidonias, Ludovico Trianni, Enrico M Clini. Subjective sleep quality during average volume assured pressure support (AVAPS) ventilation in patients with hypercapnic COPD: a physiological pilot study. Lung. 2009 Sep-Oct;187(5):299-305. doi: 10.1007/s00408-009-9167-1. PMID: 19672655
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 Sep;2(9):698-705.
Murphy PB, 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 Jun 6;317(21):2177-2186.
Struik FM, et al Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37.

Decision Summary

A. General

Respiratory assist devices (RADs) with bi-level capability, with or without a backup rate feature, are devices that use a non-invasive interface (mask) to deliver a higher level of airway pressure when the patient inhales than when the patient exhales. A backup rate feature enables the device to provide a prespecified respiratory rate if the patient’s spontaneous respiratory rate decreases below a set number.

Compared with RADs, home mechanical ventilators typically have additional ventilatory modes, monitoring, ventilator control, and safety, alarm, and backup power features (batteries).

B. Proposed Nationally Covered Indications

The Centers for Medicare & Medicaid Services (CMS) proposes to cover a RAD with backup rate feature in the home to deliver high intensity noninvasive ventilation (NIV) as treatment for an individual with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). A RAD with backup rate feature must be utilized with the intention of providing in the high intensity mode therapy(IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute). A RAD with backup rate feature is covered in the home for an initial 180-day period for individuals with COPD when all the following criteria are met:

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia; (as determined and documented by the treating clinician; no sleep testing is required);
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist, and
• The individual demonstrates one of the following characteristics:
  • Stable COPD as determined and documented by the treating clinician, without, defined as no increase in or new onset of more than one respiratory symptom (cough, sputum production, sputum purulence, wheezing, or dyspnea) lasting 2 or more days and no change of pharmacological treatment during the 24-week period before initiation of NIV, or
  • Persistent hHypercapnia present for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.

CMS proposes to cover a RAD without backup rate feature for an individual with CRF consequent to COPD who cannot tolerate high intensity NIV or for whom the backup rate feature is otherwise medically inappropriate. (High intensity continuation minimum defined as IPAP > or = 15 cmH2O and backup respiratory rate of at least 14 breaths per minute). A RAD without backup rate feature is covered in the home for an initial 180-day period for individuals with COPD when all of the following criteria are met:

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia (as determined and documented by the treating clinician; no sleep testing is required); and
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist.

CMS proposes that individuals receiving initial coverage for a RAD as described in (i), (ii) or (iii) above must be re-evaluated by day 180 after receiving a RAD, and at least every once 6 months thereafterlater, to establish that continued coverage by Medicare beyond the first 180-days and continued for another 180 days is medically necessary. Medicare will not continue coverage into the 7th and succeeding months of therapy until the required reevaluation is performed and establishes that continued coverage is medically necessary.

During a re-evaluation to establish that continued coverage is medically necessary, the practitioner must evaluate and verify that all the following usage requirements are achieved by the beneficiary in order to continue coverage of the device:

• Consistent use of the device for an average of at least 5 hours per 24-hour period4 hours per day on 70% of days within a 30 day period, and
• One or more of the following clinical outcomes has been achieved:
  • a normalization of PaCO2 (< 45 mmHg) or stabilization (current PaCO2 level is no worse than baseline), or
    • a 20% reduction in PaCO2 from baseline value, or
    • a reduction in COPD exacerbations requiring hospitalization due, at least in part, to device usage, or
    • an improvement of at least one of the following patient symptoms associated with chronic hypercapnia:
      • headache
      • fatigue
      • shortness of breath
      • confusion
      • sleep quality

Note, as described in (i) above, a RAD with backup rate feature must be utilized in the high with the intention of providing high intensity mode therapy (IPAP > or = 1520 cm H2O and backup respiratory rate of at least 14 breaths per minute).

CMS proposes that individuals receiving coverage for an HMV as described in (i) and (ii) above must be re-evaluated by day 180 after receiving an HMV, and at least every 126 months thereafterfollowing the initial usage, to establish that continued coverage by Medicare beyond the first 180-days is medical necessity. Medicare will not continue coverage into the 7th and succeeding months of therapy until the required re-evaluation is performed and establishes that continued coverage is medically necessary.

During a re-evaluation to establish that continued coverage is medically necessary, the practitioner must evaluate and verify that the HMV has been used for an average of at least 45 hours per 24-hour period day 70% of the time within a 30 day period in order to continue coverage of the device.

C. Nationally Non-Covered Indications

N/A

D. Other

Coverage of all other indications for RADs and HMVs used in the treatment of COPD, including subsequent attempts at their usage, not otherwise specified above as covered or non-covered, will be made by local Medicare Administrative Contractors under section 1862(a)(1)(A) of the Act.

See Appendix A for the proposed manual language.

Additionally, we propose to make conforming changes in Section 280.1 (Durable Medical Equipment List) of the National Coverage Determinations (NCD) Manual to add a cross reference to new NCD Section 240.9 (NIPPV in the Home for the Treatment of CRF Consequent to COPD).

CMS is seeking comments on our proposed decision pursuant to §1862(l)(3)(B) of the Act.

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Kimberly Long, Lead Analyst
Susan Miller M.D., Lead Medical Officer
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: NCA 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 the efforts of CMS to ensure that services and procedures are appropriate for the Medicare beneficiary through CMS’ consideration of the National Coverage Analysis (NCA) 280.1, to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices (RADS) for Medicare beneficiaries with Chronic Obstructive Pulmonary Disease (COPD).

Philips supports the importance of clear and comprehensive NCAs that establish well-defined clinical criteria to guide appropriate use. Such clarity is essential for both healthcare providers and Durable Medical Equipment (DME) suppliers to ensure the safe and effective use of RADs, NIPPVs, and related devices. However, we are concerned that the coverage guidelines outlined in the Proposed NCA may inadvertently create barriers to patient access and continuity of care resulting in an increase in hospitalizations and Medicare expenditures.

Overly stringent criteria for RADs or NIPPV may delay therapy initiation until patients experience significant clinical decline, which can lead to avoidable exacerbations, increased hospital admissions, and potentially higher mortality. These outcomes not only compromise patient health but also increase costs to the Medicare program. Philips urges CMS to ensure the final coverage criteria strike the appropriate balance of clinical data, treatment guidelines, and provider discretion that leads to timely access to support improved patient outcomes.

Philips is concerned that the proposed decision memo has the unintentional effect of reducing access to care without complete consideration of the standard of care. Therefore, we encourage CMS to collaborate jointly with the provider, clinical, supplier, and patient communities to revise the coverage criteria in a way that supports both positive patient outcomes and appropriate provider discretion to choose the most appropriate therapy.

Implementation Concerns

Grandfathering of Existing Patients
Philips is concerned that the draft criteria outlined in the Proposed NCA does not adequately address the needs of patients currently using NIPPVs or RADs. As written, the new criteria could disqualify beneficiaries who are stable and improving on therapy but may not meet the revised, more restrictive clinical thresholds. This creates a significant risk to continuity of care.
Many of these patients have demonstrated clinical benefit and rely on these devices to maintain their health and avoid acute events. Forcing discontinuation based on criteria that are misaligned with current clinical practice may lead to adverse outcomes, including exacerbations, hospitalizations, and increased mortality. Moreover, this shift would likely result in higher overall healthcare expenditures for the Medicare program.

Once a patient has started therapy on NIV, it is clinical practice to keep their therapy consistent when a patient has demonstrated clinical benefit. We are concerned there is no protection for patients already on NIV that once Medicare eligible, will be subject to the provisions of this NCA. In addition, as members change from Medicare fee for service to Medicare Advantage or enroll in a new Medicare Advantage plan, there needs to be a process in place to indicate the patient was on therapy prior to change in insurance coverage so not to interrupt their treatment. We urge CMS to ensure that the final NCA allows for appropriate clinical discretion particularly for existing patients whose providers have determined that ongoing use of these devices is medically necessary. Removing access in such cases would not only be clinically inappropriate but may also undermine CMS’s goals of improving outcomes and reducing avoidable costs. CMS should grandfather all patients currently on NIVs and ensure that if a patient changes plans or is newly eligible for Medicare they remain on their currently prescribed therapy to not disrupt continuity of care and increase the potential for exacerbation leading to hospitalization.

Changes in Equipment and Processes

Several provisions in the proposed NCA will require suppliers and equipment manufacturers to make changes to their processes or product configuration. Manufacturers may need to add new functions or develop software to ensure compliance with the NCA. This may include adding remote monitoring technology or functions that allow for documentation of the provisions outlined in the NCA. It is estimated that new equipment that incorporates the new provisions will take at least a year to develop and test.

Suppliers also need time to implement the provisions of the NCA. Suppliers will need to update their procedures and train staff on the new coverage requirements. To avoid disruptions in treatment, there needs to be sufficient time for manufacturers to update their devices if needed, for distributors to create new processes and train staff, and providers to adjust to the new criteria in the NCA. As a result, we ask CMS to implement the criteria one year after finalization of the NCA so that Medicare beneficiaries transition seamlessly without changes in therapy or equipment type.

Clinical Criteria Concerns

RAD General Eligibility Criteria

The NCA states a RAD with backup rate feature must be utilized in the high intensity mode (IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute). This over emphasis on high-intensity settings is not universally appropriate or applicable to every patient.

This requirement bypasses the clinical judgement of the physician and can lead to patient discomfort and reduced adherence that result in poor patient outcomes as many patients may not tolerate such high-pressure or high-rate settings. Moreover, therapeutic effectiveness does not rely on these pressures but rather on patient compliance, symptom relief, and physiological response. Imposing a specific setting requirement disregards the clinical judgment of the treating provider and may lead to patient discomfort, reduced compliance, and poorer outcomes. Philips encourages CMS to allow for flexibility in ventilator settings based on the provider’s medical assessment of each patient’s unique needs and disease progression. Enabling physicians to tailor therapy without being constrained by arbitrary numerical thresholds is critical to ensuring both appropriate utilization and positive patient outcomes.

Continuing Usage Criteria

In the NCA CMS proposes that individuals receiving therapy must be re-evaluated by day 180 and at least every six months thereafter to establish ongoing medical necessity. While Philips supports appropriate clinical oversight, we have significant concerns regarding the frequency and rigidity of this requirement.
For patients living with progressive respiratory conditions like COPD, in-person pulmonology evaluations every six months may create significant access barriers. In rural areas in-person pulmonology evaluations will be especially difficult for patients with limited mobility and transportation challenges. If a patient is not able to access their physician, they will no longer qualify for the equipment, and it will be subject to removal from the home. Removal of the equipment under these circumstances could lead to serious adverse outcomes, including increased morbidity, avoidable hospitalizations, and higher costs to the Medicare program.
Philips urges CMS to consider more flexible approaches to ongoing assessment, such as expanding the six-month reevaluation to allow for unavoidable delays in seeing a pulmonologist or allow evaluations via telehealth when clinically appropriate. This would help ensure continued access while minimizing unnecessary burden on patients, caregivers, and providers.

Recertification for RAD

The need for continuous recertification after 13 months of therapy is unnecessary. As RAD device reimbursement is capped at 13 months, patients should not be required to reassess their eligibility for the RAD device once the rental is capped nor should supplies such as masks and tubing be subject to the recertification. The need to recertify after 13 months should not be required and we suggest eliminating the assessment requirements for RAD devices after the end of the RAD capped rental period.

Requirement for Arterial Blood Gas (ABG)

The proposed 180-day re-evaluation and ongoing usage criteria requiring hours/day use and strict PaCO2 reductions may not be clinically meaningful for all patients. Many COPD patients experience gradual improvements or benefit from symptomatic relief such as reduced dyspnea and improved sleep without changes in blood gases. Requiring documentation of exact PaCO2 changes risks discontinuing effective therapy and places undue burden on both providers, patients, and their care givers.

Furthermore, for many patients, particularly those in rural or underserved areas, frequent re-testing is not feasible as they may not have easy access to a facility that provides the test and could result in disruption of therapy or even discontinuation of care. The true assessment of clinical benefit should be the patient's clinical care team.

Therefore, Philips recommends that CMS broaden the acceptable criteria for ongoing coverage to include additional diagnostic tools beyond ABGs, but most importantly, allow the clinical team to determine the patient’s need for therapy. This should include a comprehensive assessment of the clinical benefit of NIV by the clinical management team which may include measurement of PaCO2 if clinically appropriate. As part of this assessment, the provider could offer a statement of medical necessity certifying the patient requires therapy.

Time Used per Twenty-four Hours

Philips is concerned with the Proposed NCA requirement that during re-evaluation for continued coverage the practitioner must verify that the equipment has been used for an average of at least five hours per 24-hour period. While we fully support the goal of encouraging adherence, this threshold does not adequately account for individual patient variability, differing clinical scenarios, or the nature of progressive respiratory disease.

It is unclear over what timeframe the average use is measured or how periods of illness, hospitalization, or initial acclimation to therapy are accounted for. Patients often require a gradual acclimation period, and rigid adherence criteria early in therapy could lead to premature discontinuation despite potential long-term benefits. Overly strict hour-based adherence requirements risk penalizing patients who benefit from nocturnal use alone or those with progressive disease. Patients’ needs for NIPPV vary, and rigid criteria regarding daily use may exclude individuals who experience positive outcomes with shorter but still effective patterns of use. To better align with other established coverage policies and clinical practice, Philips recommends that CMS revise the daily usage requirement to an average of at least four hours per 24-hour period. This adjustment would provide necessary flexibility while still supporting adherence and ensuring that beneficiaries continue to receive medically necessary, effective care.

In closing, Philips is concerned that the draft NCA as currently written may unintentionally restrict access to clinically appropriate and medically necessary therapy for Medicare beneficiaries. The input and recommendations of leading professional societies (American College of Chest Physicians (CHEST), the American Association for Respiratory Care (AARC), the American Academy of Sleep Medicine (AASM), and the American Thoracic Society (ATS)) should be central to shaping policy that reflects real-world patient care. To conclude, we encourage CMS to continue to work with the provider, clinical, and patient communities to revise the coverage criteria in a way that supports both positive patient outcomes and appropriate provider discretion to choose the most appropriate clinical treatment for their patient.

Thank you for the opportunity to provide input into NCA 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). If you have any questions regarding our concerns, please contact me at susan.slaton@philips.com.

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I strongly urge you to not pass the new proposed guidelines for NIV. There are several factors that play into patient safety of COPD patient's. The new proposal is not going to be feasible with that population and will end up in more patients going to the hospital for treatment instead of where we can treat them in the home. I have been a respiratory therapist for 10 years and I have seen patient's lives changed through NIV.

The proposal forces the use of certain high-intensity modes rather than allowing the physician to prescribe the mode that best suits the patient’s need. In my expereince, many patients cannot tolerate the high-pressures and can be harmed if it is mandated. For patients with chronic hypercapnia due to COPD, volume-targeted ventilation, considering factors like gender, height, and condition, is often preferred over pressure-targeted ventilation, and should not be based solely on a minimum IPAP (inspiratory positive airway pressure) setting. When a patient's desired tidal volume is met, respiratory guidelines state pressure support of 8-10 cmH2O above the peak inspiratory pressure (PIP), and exceeding this, especially requiring a minimum IPAP (Inspiratory Positive Airway Pressure) over 30 cmH2O, may not provide relief, lead to noncompliance, and potentially harm the lungs.

Requiring regular arterial blood gas (ABG) tests every 6 months for non-invasive ventilation (NIV) patients is problematic due to the invasiveness, pain, and difficulty in obtaining them, especially in rural areas where patients often receive care at home. The positive impact of compliant non-invasive ventilation (NIV) on patients' lives is evident in their improved appearance, reduced hospitalizations, and increased energy levels, demonstrating its effectiveness in managing respiratory conditions.

Delaying ventilation prescriptions, including a 14-day waiting period after hospitalization and a four-week wait after pharmacological adjustments, is detrimental to patients with chronic respiratory failure, potentially leading to further decompensation or death, and should be avoided. Many hospital Bilevel machines can only be set with a back up rate, which means that patients being discharged on Bilevel will automatically have to be placed on a home RAD device with back up rate and high intensity settings.

In chronic hypercapnic patients, ventilation is crucial, and high FiO2 (4lpm or greater) should be avoided as it can reduce the drive to breathe, leading to further hypercapnia. A chronic hypercapnic patient needs to maintain an SPO2 88-92%.

The failure to grandfather existing NIV patients who are stable and benefiting from their therapy risks massive disruptions in continuity of care. Forcing these individuals to requalify under new, more burdensome criteria will almost certainly result in therapy discontinuation, exacerbation of symptoms, and higher healthcare utilization.

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In regards to the proposed changes. Bilevel therapy is not a comparable mode to NIV PC or VC therapy. Using a bilevel to treat hypercapnic respiratory disease in COPD patients is like comparing apples to oranges.

Most often a patient is treated on bilevel unit in the hospital. This is not comparable to a home bilevel unit. A hospital unit has bias flows upwards of 200lpm where as a home bilevel unit has bias flows at 60-80lpm maximum. This alone will result in bilevel failure in the home with hypercapnia. Secondly a bilevel only provides a back-up rate with apneas. Were as a ventilator provides a set rate when placed in proper modes for treating hypercapnia. Because of this a bilevel unit will not adequately control hypercapnia as we are treating CO2, not apneas.

In a published abstract completed with our patient population in 2013 titled Non-Invasive Ventilation: Reducing Re-Hospitalization Through a Clinical Drive Pathway we noted a significant hospital readmission for COPD in a 2 year study period. Our initial 20 patients which included treatment on bilevel experienced 104 hospital readmissions for COPD in 12 months prior to starting NIV therapy with an average combined total readmission cost of $873,600. Following set-up on NIV with these 20 patients in the proceeding year readmissions for COPD decreased to 4 with an average combined readmission cost of $33,600.

The results seen with this initial 20 patients has remained true with our current patient population receiving NIV therapy with COPD. With this we have also seen insurance deny NIV therapy and require patients to be placed on bilevel and bilevel with rate devices. Patients have failed bilevel therapy with increased hospital readmissions, ER visits and physician office visits. With failure we have been able to place patients back on NIV and eliminate readmissions.

Successful NIV therapy can be obtained at pressures less than 31. Increased pressures on both bilevel and NIV result in non compliance and skin breakdown trying to achieve seal. Rarely are pressure >25 needed to treat hypercapnic respiratory failure. Again we are treating CO2, not obstructions.

I would encourage CMS to reach out to any patient who has used bilevel and NIV. There is a significant difference and impacts the patient greatly when they must bump down to a bilevel patient. Our respiratory therapists and pulmonologists in this area can attest to this and would be more than willing to openly discuss outcomes with CMS and how this decision would negatively impact the care patients receive.

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Dear Centers for Medicare & Medicaid Services,

I am writing to express my strong concerns regarding the proposed National Coverage Determination (NCD) for Noninvasive Positive Pressure Ventilation (NIPPV) in the home for individuals with chronic respiratory failure (CRF) due to COPD, as published on March 11, 2025. While I understand the intent to ensure appropriate utilization, I believe that certain aspects of the proposed policy will create unnecessary barriers to care and negatively impact patient outcomes.  

Frequency of Re-evaluation:

The requirement for re-evaluation every 6 months poses a significant challenge for both patients and the healthcare system. In my experience, many pulmonologists currently have waiting periods of 6 to 9 months due to the shortage of specialists in this country. This problem is even more pronounced in rural areas, where access to pulmonologists is severely limited. Requiring patients to be seen every 6 months for the sole purpose of re-evaluation will create an unmanageable burden on the healthcare system and will likely result in delays and disruptions in care.  

Arterial Blood Gas (ABG) Requirement:

The proposed policy mandates that a repeat arterial blood gas (ABG) test be conducted every 6 months as part of the re-evaluation. ABGs are invasive and painful procedures that are not always necessary for monitoring patients with stable COPD. Furthermore, in order to obtain an ABG, patients often need to be seen by their pulmonologist to get a referral for the test. Given the long waiting times to see a pulmonologist, this requirement is impractical and will further delay access to necessary care. Excluding other reliable and less invasive tests will further limit access to care, particularly in rural areas lacking specialty facilities.  

Access to Continued Therapy:

I am deeply concerned that these proposed changes will negatively impact patients' access to continued therapy. If a physician believes that a patient is benefiting from their respiratory assist device or home mechanical ventilator, it is inappropriate to remove that support. Discontinuing treatment can lead to rapid deterioration, increased hospitalizations, and potentially higher mortality rates. CMS must clarify that the new policy will only apply to beneficiaries with new dates of service.  

Timeliness of Treatment and Implementation Timeline:

Timely access to noninvasive ventilation is crucial for effective management of chronic respiratory failure. Evidence shows that earlier intervention leads to better outcomes, including reduced risk of death, hospitalization, and emergency department visits, as well as lower overall Medicare spending. To ensure that stakeholders have sufficient time to understand and adapt to the new policy, I urge CMS to delay implementation until January 1, 2026.  

Thank you for considering my comments. I believe that revising the proposed NCD to address these concerns will help ensure that patients with chronic respiratory failure receive the care they need in a timely and effective manner.

Sincerely,

Bradley Szasz

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Breas Medical appreciates 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 dedicated manufacturer supplying RAD and HMV devices to hospitals, nursing facilities and home medical equipment (HME) providers, we would like to share our perspective on the proposed changes and the potential impact on patient care. This is feedback we have received from our customers and Clinicians within our organization, it centers around 3 main areas:

1. Requirement for re-evaluation every 180 days
2. Requirement for a repeat Arterial Blood Gas every 6 months
3. Coverage of RAD device with /without a Backup Rate

While we understand the need for ongoing assessments to confirm medical necessity, requiring re-evaluation every one-hundred and eighty (180) days could place an undue burden on both patients and providers. We recommend continued use should be determined based on clinical need defined by the prescriber, rather than specific timelines.

We also would request some further evaluation of the requirement that a repeat Arterial Blood Gas (ABG) is obtained every six (6) months as part of the re-evaluation. Arterial blood gases for measurement of PaCO2 are not readily obtained in routine home visits nor in most physician office visits given the need to process the sample in a time sensitive manner with a blood gas analyzer. The proposed regulations would require patients to visit a hospital or a qualified laboratory, and therefore, create scheduling and transportation challenges as well as additional cost to the patient and health system. In addition, it should be noted that performing an ABG may lead to complications¹.

We would like CMS to strongly consider End Tidal CO2 (EtCO2) and Transcutaneous CO2 (TcCO2) as a reliable, accessible and non-invasive alternative.

We agree that a PaCO2 value derived from an ABG is considered the gold standard, however, this measurement reflects a snapshot in time and may not be a true reflection of a homecare patient living under their normal daily routine. ETCO2 and TcCO2 can be used to monitor and trend CO2 values on a breath-by-breath basis and can be easily performed in a pulmonary physician’s office or at the patient’s home. 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^2,3 TcCO2 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^4-7

The final area that we would like to suggest further consideration is on the proposal to cover a RAD device without a backup rate feature for an individual with CRF consequent to COPD who cannot tolerate “High Intensity NIV” (IPAP > 20 cmH2O and RR > 14). High Intensity NIV is restrictive and could be uncomfortable or intolerable for the patient and may cause decreased compliance. A RAD device without a backup rate is not intended for use to treat chronic respiratory failure therefore putting the patient at risk secondary to “off label use” of a device. Furthermore, this proposal prevents physicians from ordering volume assured pressure support (VAPS) for their COPD patients with peak inspiratory pressures (PIP) lower than 20 cmH2O because the VAPS mode is not available in a RAD without rate device. Studies support that VAPS use is a more comfortable mode that provides constant auto adjustment of pressure support to achieve a target ventilation that is determined by the patient’s needs and is often a preferred mode for treating COPD⁸.

The CMS proposed NCA will eliminate this preferred, often prescribed mode of ventilation and restricting access to care for a vulnerable patient population.

In conclusion, the guidelines proposed by CMS could be considered a step in the right direction for the patient by removing qualifiers such as polysomnography (PSG) and pulmonary function (PFT) studies, we should not add other burdens to the patient or prescriber preventing the most appropriate care and ultimately impacting clinical outcomes. Breas encourages CMS to carefully consider all comments from the public, industry advocates, prescribers, and caregivers to improve and/or enhance the proposed guidelines. Through working together, we ensure patient centered outcomes and benefits. We thank you for your time and careful consideration of our comments.

References:
1) Rowling SC, Fløjstrup M, Henriksen DP, Viberg B, Hallenberg C, Lindholt JS, Alberg-Fløjborg A, Nanayakkara PWB, Brabrand M. Arterial blood gas analysis: as safe as we think? A multicentre historical cohort study. ERJ Open Res. 2022 Feb 28;8(1):00535-2021. doi: 10.1183/23120541.00535-2021. PMID: 35237684; PMCID: PMC8883174.
2) Babu, DG A, Rajesh DL, Vemula DAP, Pelluri D S. and Reddy DB S. (2024) Correlation Between End Tidal Co2 and Partial Pressure of Carbon dioxide In Arterial Blood in Patients Presenting with Respiratory Distress, European Journal of Cardiovascular Medicine 14(5), pp. 120-123
3) Ladde JG, Stacie Miller S, Chin K, Feffer C, Gulenay G, Kepple K, Hunter C, Thundiyil JG, Papa L. (2023) End-tidal carbon dioxide measured at emergency department triage outperforms standard triage vital signs in predicting in-hospital mortality and intensive care unit admission. Acad Emerg Med. 2023; 30: 832-841. doi:10.1111/acem.14703 -.
4) Lambert LL, Baldwin MB, Gonzalez CV, Lowe GR, Willis JR. Accuracy of Transcutaneous CO2 Values Compared With Arterial and Capillary Blood Gases. Respir Care. 2018 Jul;63(7):907-912. doi: 10.4187/respcare.05936. Epub 2018 May 8. PMID: 29739856.
5) Aarrestad S, Tollefsen E, Kleiven AL, Qvarfort M, Janssens JP, Skjønsberg OH. Validity of transcutaneous PCO2 in monitoring chronic hypoventilation treated with non-invasive ventilation. Respir Med. 2016 Mar;112:112-8. doi: 10.1016/j.rmed.2016.01.017. Epub 2016 Jan 27. PMID: 26874895.
6) Sørensen KM, Leicht RV, Carlsson CJ, Elvekjaer M, Porsbjerg C, Aasvang EK, Meyhoff CS. Agreement Between Transcutaneous Monitoring and Arterial Blood Gases During COPD Exacerbation. Respir Care. 2021 Oct;66(10):1560-1566. doi: 10.4187/respcare.08510. Epub 2021 Jun 1. PMID: 34074743.
7) Setar L, Lee JG, Sanchez-Pinto LN, Coates BM. Accuracy and Interpretation of Transcutaneous Carbon Dioxide Monitoring in Critically Ill Children. Pediatr Crit Care Med. 2024 Sep 1;25(9):e372-e379. doi: 10.1097/PCC.0000000000003564. Epub 2024 Jun 27. PMID: 39288436; PMCID: PMC11368163.
8) Yarrarapu SNS, Saunders H, Sanghavi DK. Average Volume-Assured Pressure Support. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–. PMID: 32809435.

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On behalf of the American College of Chest Physicians (CHEST), we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N).

CHEST supported this reconsideration request and we would like to thank CMS for the efforts that have contributed to this national coverage analysis and the opportunity to advance evidence-based treatment. CHEST applauds CMS for developing essential improvements that will lead to optimized outcomes in the management of Chronic Obstructive Pulmonary Disease (COPD).

CHEST would request CMS to consider the following that we feel are critical to ensuring patient access and optimizing outcomes:

Initial Coverage Criteria

High intensity mode requirement – The recommendation for high intensity ventilation in the Canadian Thoracic Society Guidelines is a conditional recommendation with low certainty evidence. A conditional recommendation indicates there is uncertainty in the benefits and that different patients may require varying approaches. As noted in the guidelines, there is no clear definition of “high intensity” ventilation. Patients often need time to acclimatize to higher intensity settings with progressive adjustments, as was seen in the studies cited in the decision memo (Kohnlein, et al., 2014, Murphy, et al., 2017, Coleman, et al., 2019). A requirement to initiate patients at these high intensity settings will negatively impact patient tolerance and compliance with the device. We would suggest eliminating this requirement for initiating a RAD and to instead consider it a possible goal of therapy. While we do not feel specific settings should be specified, if this is necessary, we would suggest a goal IPAP = 18 cmH2O with a backup rate of 14 based on the cited 2014 meta-analysis (Struik, et al., 2014).

Continuing Usage Criteria

Consistent use – We suggest consistent use in the continuing usage criteria for a RAD or HMV be defined as use of the device for an average of at least 4 hours per day on 70% of days within a 30-day period. Requiring 5 hours of usage every night for patients will be overly burdensome and is impractical. Patients may not have 100% daily usage for various reasons including acute illness or hospitalization. For example, more than 25% of patients had less than 4 hours of nightly usage at 6 and 12 months in the Murphy study (Murphy, et al., 2017). We believe a criterion of 4 hours per day on 70% of days within a 30-day period will streamline implementation given it is a logical extension of current practice.

Re-evaluation for RAD – While we agree with the recommendation for re-evaluation by day 180, we feel that requiring subsequent evaluation every 6 months thereafter is overly burdensome to patients and would worsen patient access to evidence based care. There does not appear to be any citable evidence to support the need for re-evaluation every 6 months beyond the initial 180 days. We would propose eliminating the need for an evaluation every 6 months. If it is necessary to specify a time interval for re-evaluation, we would propose every 12 months as a more reasonable alternative.

Additionally, we urge CMS to consider the following comments to further strengthen and align the proposed decision memo with evidence-based treatment to improve patient outcomes and reduce barriers to implementation:

Sleep apnea – We suggest a change in the language of the criteria regarding sleep apnea, as an extension of current practice based on the current LCD: “Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).”

Stable COPD – We suggest a change in how stable COPD is defined. Requiring a 4-week period without change in pharmacologic management will be burdensome to the patient and could delay evidence-based care. Patients requiring a RAD for chronic respiratory failure in COPD might require more frequent changes to their medication regimen to achieve better symptom control. We feel that a 2-week period without a change in pharmacologic management is more reflective of clinical practice and will be less burdensome to patients.

CHEST is confident that the adoption of these comments will advance evidence-based treatment and optimize outcomes in the management of COPD. We thank CMS for taking CHEST's comments into consideration.

References:
Coleman JM, et al. Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019 Sep;16(9):1091-1098.
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 Sep;2(9):698-705.
Murphy PB, 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 Jun 6;317(21):2177-2186.
Struik FM, et al Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. Respir Med. 2014 Feb;108(2):329-37.

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Medical Comfort Systems operates four locations specializing in the care of patients with complex respiratory conditions. We are submitting comments regarding Non-Invasive Positive Pressure Ventilation (NIPPV) for the treatment of Chronic Respiratory Failure (CRF) in patients with Chronic Obstructive Pulmonary Disease (COPD) in the home setting.

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Request for Pause in Reconsideration of the HMV NCD: We urge CMS to pause the reconsideration of the Home Mechanical Ventilation (HMV) National Coverage Determination (NCD) to allow further technical assessments and the inclusion of additional clinical data, ensuring decisions are based on comprehensive evidence.

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Daily Use Requirement: The proposed five-hour daily use benchmark for HMV therapy is unsupported by clinical evidence. Patients’ needs vary, and rigid criteria may exclude those who benefit from shorter, effective usage patterns. We advocate flexibility, allowing providers to document the clinical benefits specific to each patient. This approach is supported by clinical research, such as the study published in the American Journal of Respiratory and Critical Care Medicine, which emphasizes the importance of individualized care in respiratory therapy to optimize patient outcomes (https://www.atsjournals.org/doi/10.1164/rccm.202006-2382ST).

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Pressure Limitations for Qualification: The proposed pressure limitations for qualifying HMV therapy are not appropriate. The effectiveness of HMV depends more on therapy modes and settings than on pressure levels alone. HMVs provide higher peak airflow and inspiratory pressure than BiPAPs/RADs, which is crucial for effective ventilation and minimizing lung injury.

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Definition of Hypercapnia: We recommend adopting a PaCO2 level of >45 mmHg to define hypercapnia, aligning with NIH guidelines and maintaining consistency in clinical practice.

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Physician Discretion for HMV Use: HMV therapy decisions should be made by the patient’s physician, considering disease progression and individual patient needs. Licensed respiratory therapists (RTs) should also be recognized as integral members of the clinical care team for home care and monitoring.

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Apria is a leading supplier of home medical equipment and related services, with over 270 locations nationwide serving more than 2 million patients per year, including large populations of traditional Medicare beneficiaries and Medicare Advantage members. Our valuable services enable patients to avoid hospitalization, live healthier and independent lives, and improve their quality of life at home.

We appreciate the opportunity to provide feedback regarding the proposed decision memo discussing NIPPV for the treatment of chronic respiratory failure consequent to COPD. However, we are extremely concerned about the harmful impacts that these proposed policies will have on patient care. Although these changes were intended to streamline eligibility and curb unnecessary device usage, the proposal dangerously limits patient access to life-supporting therapy, compromises physician autonomy, and burdens healthcare providers with excessive regulation. The proposal’s overly restrictive qualification criteria, rigid device mandates, and unnecessary testing requirements restrict physicians’ treatment options for patients who need ventilation support. If implemented, these changes will delay life-supporting care and put these vulnerable patients at risk for negative health outcomes.

We therefore strongly urge CMS to rescind this rule without delay. After this rule is rescinded, we propose additional review and input from the administration on the potential impact of government expenditures due to rehospitalization of our most vulnerable patients and putting patients at risk.

Our key concerns and recommendations are as follows:

Coverage criteria are based on a small subset of clinical evidence:
The proposed rule imposes excessive medical micromanagement by dictating overly restrictive eligibility criteria, rigid device mandates, and unnecessary testing limitations that restrict physicians’ treatment options for chronically ill patients who need ventilation support. Many of the coverage requirements proposed in the policy are based solely on European studies from many years ago. While we acknowledge that the cited studies are valuable, they represent only a few of the many studies regarding ventilation, and exclusive reliance on them overlooks other studies such as those using recent CMS data collected in the Research Identifiable File [1,2,3], among others. There is no evidence that one study or therapy is superior to the other given varying times in which the studies were conducted, varying methodologies, and differences in populations and device types. As a result, there is true clinical equipoise based on cited literature which requires the judgment of the treating physician to adjudicate on a case-by-case basis. The need for clinical judgement is particularly acute since many of the parameters set on home mechanical ventilators require significant clinical nuance to properly match the needs of each patient.

Studies that suffer from significant threats to external validity should not be used to create treatment rule sets and restrict device access that would interfere with physicians’ clinical judgement and limit their ability to personalize patient care and decisions.

Initial qualification criteria are excessive and therefore limit access to life supporting treatment:
• PROPOSED: The individual exhibits persistent hypercapnia as demonstrated by PaCO2 = 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2.

o COMMENTS: Hypercapnia, by definition, is the increase in partial pressure carbon dioxide (PaCO2) above 45 mmHg [4]. By restricting coverage to hypercapnic patients with PaCO2 = 52mmHg, this proposal prevents physicians from properly treating all hypercapnic patients and denies treatment for those with PaCO2 levels between 46-51 mmHg who would benefit from ventilation therapy [5,6].

Worse, hypercapnia is often a dynamic value, while the standard set by CMS is rigid, static, and inflexible. When patients are hypercapnic, as judged by clinical and objective data such as CO2 values, physicians should be able to make clinical decisions and order appropriate ventilation support to match the needs of each patient.

Additionally, the proposal limits testing to an arterial blood gas (ABG) which is painful and invasive, and not available in all locations where care is provided to hypercapnic patients. There are other tests that should be used and that can reliably confirm hypercapnia with less patient discomfort [7,8,9,10].

o RECOMMENDATIONS:
1) Lower the qualifying threshold for both RAD and HMV to PaCO2 > 45 mmHg
2) Accept other tests if approved by the prescribing physician that confirm hypercapnia, such as but not limited to, PvCO2, ETCO2, transcutaneous PCO2, and CBG to meet RAD and HMV testing criteria

• PROPOSED: Sleep apnea is not the predominant cause of hypercapnia.

o COMMENTS: COPD with OSA comorbidity can lead to more severe nocturnal hypoxemia and worse clinical outcomes compared to either condition alone. Proper device access for ventilation support to treat COPD patients should not be limited or restricted just because the patient also has sleep apnea. These patients require a comprehensive approach that addresses both conditions appropriately. This proposal will create access issues for the patient population with co-morbid COPD and sleep apnea.

o RECOMMENDATION:
The reference to sleep apnea should be removed from the proposal to avoid misinterpretation and the potential for restricted access to therapy for COPD patients who also have sleep related comorbidities.

• PROPOSED: The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist.

o COMMENTS: Including this subjective requirement as a qualification criterion will create unnecessary denials, further limiting access to care. The prescribing physician should be trusted to determine the best therapy for a given patient, using their judgement to perform any needed holistic evaluations. Additionally, Medicare already requires DMEPOS suppliers to ensure that the beneficiary and/or caregiver can use the equipment properly and safely as part of the equipment set-up, thus a specific additional regulatory requirement is confusing, redundant, and duplicative.

o RECOMMENDATION:
Remove this requirement and allow the physician to determine the best therapy and the DME supplier to ensure proper training.

• PROPOSED: The individual demonstrates one of the following characteristics: stable COPD, defined as no increase in or new onset of more than one respiratory symptom (cough, sputum production, sputum purulence, wheezing, or dyspnea) lasting 2 or more days and no change of pharmacological treatment during the 4-week period before initiation of NIV, or persistent hypercapnia for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.

o COMMENTS:
It is unreasonable to mandate “no change of pharmacological treatment during the 4-week period before initiation of NIV.” Physicians must be allowed to change pharmacological treatment if warranted for the patient’s condition without causing a delay in the patient’s access to ventilation treatment.

It is also unreasonable to mandate “persistent hypercapnia for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.” To require persistent hypercapnia for at least 2 weeks post hospital discharge after an exacerbation (before the physician can order NIV treatment via HMV) is an example of regulatory involvement in mandated medical management and interference with physician decision making. Given that even expert guidelines are uncertain about the best approach to the treatment of patients recovering from acute exacerbations, physicians must be allowed to determine the best approach for each patient.

Furthermore, the proposed rule discusses NIPPV for the treatment of chronic respiratory failure consequent to COPD. Limiting the rule to COPD omits other chronic restrictive lung diseases that also require ventilation therapy.

o RECOMMENDATIONS:
1) Given the potential for significant harm to patients including hospitalization, recurrent exacerbation leading to loss of lung function, and death, we request the removal of both requirements: “no change of pharmacological treatment during the 4-week period before initiation of NIV” and “persistent hypercapnia for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.”

2) We request that the coverage criteria for NIPPV (including RAD and NIV via HMV) include other chronic restrictive lung conditions such as but not limited to Idiopathic Pulmonary Fibrosis (IPF), Interstitial Lung Disease (ILD), Sarcoidosis, Coal Worker’s Pneumoconiosis (Black Lung disease or CWP), etc.

The 24-hour hospital device usage requirement has no clinical basis and restricts the physician’s ability to prescribe the appropriate device and settings for home use:
• PROPOSED: CMS proposes to cover a RAD with or without backup rate feature in the home immediately upon hospital discharge for an initial 180-day period for individuals with acute CRF due to COPD, if the individual required a RAD within the 24-hour period prior to hospital discharge to avoid rapid symptom exacerbation or rise in PaCO2. The type of RAD covered (with or without backup rate feature) must be the same as that used during the last 24 hours of the inpatient admission.

o COMMENTS: This proposal has no basis in the literature or in the way pulmonary medicine is routinely practiced. A metric often used to assess a patient’s readiness for safe hospital discharge is when they can be removed from ventilation for 24 hours without experiencing a dangerous, ICU requiring decompensation. This ability to temporarily reduce their ventilatory support does not imply that patients can be completely weaned from ventilation or that they require adjustments in ventilation in the 24 hours prior to hospital discharge. Additionally, when in a hospital, physicians, nurses, and respiratory therapists continually monitor patients and adjust device settings based on testing, tolerance, protocols, etc. These same settings should not be mandated for home use where the patient does not have 24-hour patient monitoring and adjustment. The physician should be given the ability to prescribe the right modes, settings, and interfaces for use in a home setting which often differ quite notably from the settings used in a hospital. Furthermore, the requirement to align home settings with a hospital setting can result in artificially prolonged hospitalizations where physicians are prevented from discharging patients due to inability to ensure safe, appropriate home mechanical ventilation due to the need to match settings to those prescribed in the outpatient setting.

o RECOMMENDATION:
Allow physicians to change the device settings at discharge and remove the requirement mandating that the RAD device must be the same as that used during the last 24 hours of inpatient admission.

RAD “High Intensity” requirement is not clinically sound and forces patients to use devices not intended to treat ventilation insufficiency:
• PROPOSED: A RAD with backup rate feature must be utilized in the high intensity mode (IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute).

o COMMENTS: The proposal to restrict patients who can’t tolerate IPAP >20 to a RAD without a backup rate is without precedent and is not based on clinical outcomes data. The inability to tolerate high Peak Inspiratory Pressure (PIP) should have no bearing on whether RADs with backup rate are covered. Furthermore, this proposal also prevents physicians from ordering volume assured pressure support (VAPS) for their COPD patients with peak inspiratory pressures (PIP) lower than 20 cmH2O because the VAPS mode is not available in a RAD without rate device. VAPS is a more comfortable mode that provides constant auto adjustment of pressure support to achieve a target ventilation that is determined by the patient’s needs and is often a preferred mode for treating COPD [11,12,13]. The CMS proposal is taking away this preferred, often prescribed mode of ventilation and restricting access to care for a vulnerable patient population.

Most importantly, the RAD without backup rate device is not intended for use to treat chronic respiratory failure or ventilation insufficiency. The high-pressure requirement forces patients with pressures < 20 cmH2O and rates < 14 to use a RAD without rate, contradicting clinical indications and FDA-approved labeling for the device. RAD with backup rate devices are intended to treat obstructive sleep apnea (OSA) and not to treat ventilation failure of any degree as defined in the “Indicated Use” section for each E0470 RAD without rate user manual [14,15,16]. CMS’ proposed requirement for COPD patients therefore mandates inappropriate use of respiratory therapy devices that are not intended to treat COPD, CRF, or any ventilation insufficiency condition. Hypercapnic patients who qualify for RAD must therefore have access to E0471 RAD with backup rate regardless of pressure or rate settings.

o RECOMMENDATIONS:
1) Remove the high intensity pressure and rate requirements for RAD with backup rate (E0471).
2) Remove requirements that force physicians to prescribe the RAD without backup rate device (E0470) for off-label use; allow them the autonomy to prescribe the appropriate device based on their clinical judgement.

Continued coverage requirements for RAD are overly burdensome for DME suppliers and can be very challenging for patients (especially those in rural communities):
• PROPOSED: Patients must be re-evaluated by day 180 after receiving a RAD, and at least every 6 months thereafter, to establish that continued coverage by Medicare beyond the first 180 days is medically necessary.

o COMMENTS: Ongoing re-evaluation every 6 months is an excessive and unduly burdensome requirement for a patient population with chronic, progressive respiratory disease. In-person pulmonology evaluations every 6 months will be especially difficult for elderly, ill patients with transportation challenges and those in rural areas, who often have limited access to specialists.

o RECOMMENDATIONS:
1) Remove the ongoing 6-month assessment requirement
2) Require annual medical need documentation within the preceding 12 months consistent with CMS’ Standard Documentation Requirements Policy Article [17]

• PROPOSED: Consistent use of the device for an average of at least 5 hours per 24-hour period

o COMMENTS: This arbitrary five-hour average use requirement, which is more restrictive than any other Medicare policy regarding device usage, is not supported by clinical research (including the clinical trials referenced in the proposal, which did not report correlation between hours of device use and improved outcomes). Implementation of this criterion would unfairly deny continued access to ventilation therapy for many patients who compliantly use and benefit from the device but don’t meet the average hourly threshold, leading to potentially negative clinical outcomes, emergency room visits, hospitalizations, etc.

While there's no specific literature stating a requirement for 5 hours of NIV usage, studies suggest that improvements in respiratory parameters and outcomes are often observed with lower levels of NIV usage [18,19].

Initial coverage criteria for HMV need to be clarified and expanded to ensure patient access to care:
• PROPOSED:
The individual demonstrates at least one of the following characteristics:
(1) Requires oxygen therapy at an FiO2 = 36% or = 4L nasally; or
(2) Requires ventilatory support for more than 8 hours per 24-hour period; or
(3) Requires the alarms and internal battery of a HMV, because the patient is unable to effectively breathe on their own for more than a few hours and the unrecognized interruption of ventilatory support is likely to cause a life-threatening condition if the patient or caregiver cannot be otherwise alerted.
(4) None of the below are likely to be achieved with consistent use of a RAD with backup rate feature for 5 hours per 24-hour period during an adequate trial period because the patient’s inspiratory pressure needs exceed the capabilities of a RAD as justified by the patient’s medical condition:
? normalization of PaCO2, or
? a 20% reduction in PaCO2 from baseline value, or
? a reduction in COPD exacerbations requiring hospitalization due, at least in part, to device usage has occurred, or
? an improvement of at least one of the following patient symptoms associated with chronic hypercapnia: headache, fatigue, shortness of breath, confusion

o COMMENTS: The proposed rule attempts to provide a clear pathway to NIV via HMV; however, the list of qualifying characteristics is confusing and missing important criteria which can lead to inappropriate denials.

o RECOMMENDATIONS: Revise the above section for clarification and accuracy as follows:
The individual demonstrates at least one of the following characteristics:
(1) “Requires oxygen therapy at an FiO2 =36% or = 4L bled into the device; or”
(2) “Requires ventilatory support for more than 8 hours per 24-hour period or is prescribed multiple pre-set pressures by the physician; or”
(3) “Requires alarms and/or an internal battery as determined by the physician; or”
(4) “Requires Peak Inspiratory Pressures (PIP) that exceed the capabilities of a RAD device as determined by the physician; or”
(5) “Patients who weigh less than the minimum weight requirements on a RAD (as outlined in the device’s Clinical Guide); or”
(6) “Patients who require modes or settings that a RAD device is not capable of delivering.”

Coverage upon hospital discharge:
• PROPOSED: CMS proposes to cover an HMV used in a volume targeted mode immediately upon hospital discharge for an initial 180-day period for individuals with acute on chronic respiratory failure due to COPD if the beneficiary’s needs exceeded the capabilities of a RAD (with or without backup rate feature) and required usage of a ventilator within the 24-hour period prior to hospital discharge to avoid rapid symptom exacerbation or rise in PaCO2.

o COMMENTS: Similar to our concerns expressed in previous sections regarding the 24-hour period requirement for RADs, the physician should not be restricted from prescribing the appropriate device upon discharge based on their clinical judgment and the patient’s care needs in the home.

o RECOMMENDATIONS:
Omit the required usage of a ventilator within the 24-hour period prior to hospital discharge mandate.

Continued coverage requirements for HMV are unclear and imply that ongoing ABG testing is required every 6 months, subjecting elderly, ill patients to an invasive and painful procedure:
• PROPOSED: CMS proposes that individuals receiving coverage for an HMV as described in (i) and (ii) above must be re-evaluated by day 180 after receiving an HMV, and at least every 6 months thereafter, to establish that continued coverage by Medicare beyond the first 180-days is medically necessary.

o COMMENTS: The reference to section “(i)” which mandates ABG testing, implies that this painful, invasive testing is required every 6 months for continued coverage.

o RECOMMENDATIONS:
1) Remove any reference requiring ABG testing for continued coverage.
2) Apply the same evidence of continued use and medical need within the preceding 12 months consistent with CMS’ Standard Documentation Requirements Policy Article.
3) Remove the ongoing 6-month assessment requirement.
4) Remove the 5-hour usage requirement and apply the same evidence of continued use and medical need within the preceding 12 months consistent with CMS’ Standard Documentation Requirements Policy Article.

Unfunded mandates harm businesses with complicating, costly regulation:
The proposed rule would have a significant negative financial impact on DME suppliers, who would be responsible for managing burdensome administrative procedures which would increase operational expenses and divert resources away from direct patient care. To ensure proper billing and reimbursement, suppliers would be required to purchase additional device monitoring tools and expand staff to monitor, procure, and maintain medical record documentation to verify continued coverage every 6 months. This would be especially costly when RAD devices convert to sale, as the supplier would only be reimbursed for the provision of supplies.

Additionally, suppliers would be at a high risk of losing reimbursement for equipment that is still in the patient’s possession under a physician’s order if the patient is unable to meet with their physicians within the required re-evaluation timeframe. In these scenarios, suppliers would be prohibited from picking up equipment without a physician’s discharge order or an Against Medical Advice (AMA) document signed by the patient. This is especially concerning as the rule indicates, “Medicare will not continue coverage into the seventh and succeeding months of therapy unless the re-evaluation is performed.” This leaves suppliers with providing equipment to patients that will not be reimbursed until the re-evaluation is completed while they also continue to incur operational costs to procure medical documentation.

Although the proposed rule would significantly increase supplier costs, there is no mention in the proposal for increased supplier reimbursement rates to help cover these additional expenses. Therefore, reimbursement rates for these devices must be increased to ensure the financial viability of DME suppliers, many of which are small business owners.

ADDITIONAL RECOMMENDATION:
Once the policy is revised and finalized, we recommend that CMS implement standardized electronic clinical data element templates for RAD and HMV identifying initial and ongoing coverage criteria.

CMS should ensure that prescribers know what information is necessary to establish medical necessity and provide an easy tool for physicians to provide the necessary documentation rather than relying on medical record chart notes. Physicians rarely write notes that meet Medicare auditors’ views of what is necessary to establish coverage criteria. This often results in inappropriate denials based on insufficient medical record notes, despite patients meeting the coverage criteria.

CONCLUSION:
The proposed rule will dramatically interfere with physician decision making, overburden suppliers with administrative requirements, catastrophically worsen already challenging healthcare access issues, and exacerbate already significant treatment delays. This will inevitably result in poor health outcomes and costly hospital readmission for CMS beneficiaries. Patients requiring NIPPV therapy are chronically ill with progressive diseases and should not be subjected to excessive and unnecessary regulations that could deny them access to life-supporting treatment.

Therefore, we strongly urge the immediate rescinding of this policy so it can be thoughtfully rewritten with clear, common-sense guidelines designed specifically to benefit patients, physicians, and providers alike - elevating standards of care, enhancing patient outcomes, and responsibly reducing healthcare costs for all Americans.

Thank you for your consideration of our comments and recommendations. Please feel free to contact me at perry.bernocchi@owens-minor.com if any questions arise or you wish to discuss the above.

Sincerely,
Perry Bernocchi, Chief Executive Officer

______________________________________________________________________________________________________

REFERENCES:

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Please don't make these changes.

Hospital readmits will increase, NIV therapy has proven to decrease readmits.
Home ventilation therapy has proven to decrease in patient stays.
Repeated blood gas study. The repeated test every 6 months may cause a false negative. While the patient is using the NIV, his/her CO2 levels will decrease. Is the expectation to have the patient office the prescribed method of treatment for 24-72 hours before the new gas study? This requirement seems a bit reckless.

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Seeing a doctor every 6 months isn’t unreasonable for most patients, some already do because they have COPD and their doctor wants to see them that often. However, some patients struggle to get out of the house because they are bed-bound. My one invasive patient has no smoking history, but weighs over 600 pounds. His doctor comes to him at home, but it’s not a pulmonologist.

The ABG requirement is unfair to the patients because it is invasive and difficult to have done, as it requires a visit to the hospital because typical lab companies like LabCorp do not perform arterial blood draws. ETCO2 monitoring is more reasonable as it doesn’t require the patient making yet another trip to a facility and spares them the pain of being stuck by that large bore needle.

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Frontier Home Medical, Inc. greatly appreciates the opportunity to provide feedback during the open period regarding the proposed RAD/NIV NCD for our patient population with a COPD diagnosis. Our concerns are below.

• GRANDFATHERING of current RAD/NIV Users
o In the proposal there does not appear to be any guidance for our current RAD/NIV patients. We are very concerned that the proposed NCD does not “grandfather” patients who are currently using and benefiting from RAD or NIV devices. Many of these patients will not have the historical documentation required under the newly proposed guidance, despite clearly benefiting from their current therapy. Forcing them stop or removing their current therapy because of missing paperwork- rather than clinical need- could lead to hospitalization, deterioration of health or potentially death. We feel strongly that physicians should be trusted to determine ongoing medical necessity without risking the removal of life-sustaining equipment specifically in these patients that are already utilizing this equipment.
• Therapy Use Threshold (5-Hour Average Per Day)
o The proposed requirement that patients average 5 hours of daily device use is inconsistent with established standards. Current adherence definitions-such as 4 hours per night on 70% of nights over a 30-day period over the 1st 90 days- are widely accepted and clinically supported to allow the patient time to assimilate to their other sleep therapies. Raising the threshold could disqualify patients from still benefiting from therapy and will likely create confusion and disruption across the continuum of care, from patients to suppliers to manufacturers. We feel there must be more robust details if any sort of adherence guidelines is required.

• Re-Evaluation Burden in Six-Month Intervals
o We service the state of Nebraska which has a large area of extremely rural population centers. The current proposal requiring a re-evaluation every six months creates an unnecessary and unrealistic burden, particularly for patients in a rural or underserved area. These individuals frequently struggle to access even annual care. Increasing the frequency to allow this life-sustaining equipment coverage will introduce additional barriers. Additionally, the financial strain placed on these patients because of additional appointments and potential co-pays could prevent patients from continuing treatment, thus potentially resulting in worsened health outcomes.
o In addition to the complexity of additional visits, the proposed requirement for ABG testing every 6 months adds another level of complexity in the rural population base as access to ABG draws are often unavailable in the rural settings outside of the in-patient hospital scenario. Additionally, ABGs are invasive and often a painful procedure even when access is available. Many providers have moved away from routine ABG testing for chronic disease management and instead rely on less invasive and clinically valid alternatives, such as end tidal C02 monitoring. Excluding these potential methods of continued need assessment will create a significant barrier for patients who depend on long-term ventilation therapy.
o Furthermore, the proposed C02 threshold of >/52 mmHg is concerning among clinicians. Research and clinical experience indicate that hypercapnia can become clinically significant at levels of 46-51 mmHg. By setting the threshold too high, the proposed policy risks excluding patients with a clear clinical need for therapy but may not meet this arbitrary cutoff. Again, this approach may result in delayed care/benefit of this therapy resulting in a worsened long term health outcome in a patient with established chronic respiratory condition.

• Challenges with Hospital Discharge to Home Transitions
o The proposed requirement for patients to be on the “same or similar” device within 24 hours of discharge poses a significant challenge. In many acute care settings, the ventilators which are used differ from the equipment used in the home setting. Enforcing this requirement could delay or even prevent timely access to the appropriate home-based device, threatening patient safety, continuity of care and likely adding additional expenses to the health care system. This could impact delay of discharge and potentially long-term health of these chronic patients worsening if they were to be discharged without therapy.
o Additionally, discharge readiness and planning rarely align perfectly with strict coverage timelines. Requiring precise coordination between hospital clinical protocols and payer policies for home therapy creates unnecessary confusion for clinicians and equipment providers. This could result in delaying life-sustaining therapy at a very critical point in the patient’s recovery.

In summary, we again appreciate the opportunity to provide feedback regarding our concerns. We do feel moving forward with the proposed NCD as written would cause multiple issues as outlined above. Each of these issues could result in both a reduction in patient health outcomes and additional expense to our health care system both in cost related to new requirements and a deterioration of chronic patient health resulting in more acute care costs.

Sincerely,

Corey Keezer RRT
Executive Director
Frontier Home Medical, Inc

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Requiring arterial blood gas (ABG) testing every six months is non-sustainable. This would require a costly unnecessary visit for the blood draw and lab testing as well as provider time to review the results. Also, ABG testing is invasive and can be painful for patients. Many patients who don’t live near specialty medical facilities, especially in rural areas, will find it difficult to meet this requirement causing them to not have the equipment available to help maintain a normal lifestyle with their disease.

The proposal also forces the use of certain high-intensity modes rather than allowing the physician to prescribe the mode that best suits the patient’s need. In my expereince, many patients cannot tolerate the high-pressures and can be harmed if it is mandated. This decision should be left to the doctor.

The current standard for therapy is for a patient to use the device for for =4 hours per night on average. Moving to a the 5 hour average will disrupt patient care for some. Many with respiratory diseases, do not sleep a full night due to their condition.

Patients already using NIV devices may not meet the new clinical coverage criteria required in the draft NCD. If a physician believes that the patient continues to benefit from the device, it would be inappropriate to remove the device from them and risk hospitalization and/or death. CMS MUST clarify that the new policy will only apply to beneficiaries with new dates of service.

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As the Director of Clinical Services at a manufacturer and distributor of respiratory therapy devices and a Respiratory Therapist with over 15 years of clinical experience, I would like to address several areas related to the proposed NCD on behalf of Movair. Clarification to help determine when certain devices are appropriate is necessary and overdue. I agree that there should be clearly defined pathways for patients to be prescribed the appropriate ventilation device without tried-and-failed policies that unnecessarily delay patient care. Removing the overnight oximetry testing requirement for RAD devices would also be appreciated. However, there are several concerns with the proposal that I would like to address:

1) Proposed testing requirements accept only arterial blood gases (ABGs) to establish a patient’s hypercapnia. ABGs are an invasive and often painful blood test. This raises patient access concerns, as hospital labs or inpatient stays are the only places to perform this test. Venous Blood Gas (VBG) testing, transcutaneous CO2, or capnography (EtCO2) should be considered viable alternatives. Additionally, FEV1 values from spirometry have been used in the past to establish the severity of COPD. Spirometry is useful for diagnosing COPD and quantifying respiratory failure and is used in other international guidelines.1 The ATS Guidelines from 2020 also evaluate patients based on PFT decompensation and hypercapnia at PaCO2 levels >45mmHg.2 The panel is requested to re-evaluate restrictive, painful testing criteria to be more inclusive and prevent patient access issues.

2) Requiring patients who need RAD or HMV devices to have used and benefitted from an equivalent device within 24 hours of discharge is an undue burden. Discharge requirements vary from hospital to hospital, and patients are often trialed for a period of time without devices as a prerequisite to discharge. Hospital devices are also not equivalent to home devices, and terminology is often obfuscated in charting, leading to inaccurate equipment requests and delays in care for vulnerable patients. Request that this requirement be removed and replaced in RAD and HMV sections by language supporting provider expertise and clinical judgment in the appropriate prescription of ventilation devices.

3) While initial determination between RAD with backup rate and HMV is appreciated, we suggest that a patient should also qualify for HMV units if there is a need for multiple prescriptions and/or daytime ventilation. The recently convened Technical Expert Panel report cited the need for mouthpiece ventilation to help determine between using a RAD with backup rate or a HMV device.3 Mouthpiece ventilation has been proven to be an effective supplement to nighttime therapy settings and was listed as non-inferior to nasal NIV in improving outcomes in COPD patients.4 Because homecare RAD devices cannot provide multiple pressure prescriptions or mouthpiece ventilation, this must be a consideration for moving directly to a HMV device without having to try and fail a RAD device with or without backup rate. Recommend immediate access to HMV if one or more of the following is true:

1. Patient requires daytime ventilation modes or multiple pressure settings
2. Patient requires complex alarms and/or backup battery
3. Patient requires pressures higher than a RAD device can provide
4. Patient requires settings or modes not available on RAD devices
5. Patient requires oxygen equal to or greater than 4L/min or 36% FiO2
6. Persistence of hypercapnia or inability to tolerate RAD despite adequate adherence to BPAP therapy as determined by any acceptable testing

4) Requiring that RAD with backup rate be used only with “High Intensity” settings (IPAP>20cmH2O, RR>14) is based on small European studies and does not meet the needs of the patient population for US Medicare. There are times that a RAD device would be beneficial at lower IPAP, lower RR, or both, and limiting these devices to a narrow pressure range and high RR requirement will likely cause more patients to be prescribed RAD devices without backup rates. A RAD device with rate or HMV device should be prescribed if a patient requires a backup rate of any frequency. Per their instructions for use, RADs without backup rates are intended to treat OSA, not COPD. We recommend removing the language around “high intensity” settings and prescribing devices at the treating physician’s discretion.

5) Including a 14-day waiting period after hospitalization before prescribing any ventilation is unnecessary and contributes to significant delays in care. Additionally, it is unreasonable to suggest that a patient must wait four weeks after pharmacological adjustments before being prescribed a RAD or HMV device. Patient’s medications are adjusted and reconciled as a routine part of hospitalization and discharge. This rule, as proposed, essentially mandates a four-week wait between hospitalization and prescription of ventilation, putting patients at risk for further decompensation, illness, or death. A recent study suggests that delaying appropriate care after diagnosis of chronic respiratory failure is detrimental to patients and limits the positive effects of ventilation.5 These devices should be made available to patients immediately after a qualified order is processed, without unnecessary delays in care.

6) We are unaware of clinical justification for requiring 5 hours of use per 24-hour period. There is no reasonable case for use requirements to be more restrictive than current Medicare PAP compliance guidelines. Device usage varies, particularly as patients are initially beginning therapy. Additionally, hospitalizations are common in this population and would adversely affect compliance information. If this is not based on defined research, we suggest removing the requirement and allowing ongoing needs to be determined at the discretion of the managing physician. If compliance guidelines must be initiated, they should not be more restrictive than current PAP guidelines.

7) We request clarification on the 180-day follow-up guideline for devices. Staffing shortages and long wait times may cause an undue burden to patients in rural areas as well as prescribers and providers of medical equipment. We suggest that this requirement be made once a year and that additional, invasive ABG testing is not included. Face-to-face documentation, via in-person or telehealth visits on a yearly basis, is suggested. This is in line with re-assessment guidance in other areas of CMS policy.

Thank you for the opportunity to comment on these important guidelines.

Sincerely,
Dan Dunmire, RRT
Director of Clinical Services
Movair

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To Whom It May Concern-
I urge you not to pass the new proprosed guidelines for NIV. There are several factors that play into this for the safety and well being of the COPD patiennts. A pressure at 30cm is an extreme amount of pressure for someone to tolerate. COPD patients need a constant back up rate which also a Bipap ST does not offer. Patients that have a high CO2 need a comfortable pressure, a true back up rate to be able to wear the NIV for compliance and to try to elimate hospitalizations. The new proposal is not going to be feasible with that population and will end up in more patients going to the hospital for treatment instead of where we can treat them in the home. Please also discuss with the clinicans that deal with it on a daily basis.
Copd and sleep apnea are not treated the same way. Instead of making it impossible for companies to get reimbursed for treatment on patients, please put the patients, caregivers and clinicals above anything. If you are living with COPD you may feel differently. Also, would you want to wear a mask, risk barotrauma at a pressure of 30cm??
ABG's, and documenation should be all that is needed to prove the respiratory failure and allow DME companies to take care of patients in the home. Look at the cost vs benefit.
Thank you,

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To whom it may concern:

Requirement of IPAP >20 for RAD with a backup rate does not consider the individuals lung compliance or physiology when attempting to decrease PCO2 below the 52mmHg threshold. Lower IPAP pressures could still be effective when combined with a set respiratory rate to achieve the desired Minute Ventilation allowing for a decrease in the patient’s hypercapnic state. This LCD does not take into consideration volume targeted modes which allow for a range of pressures to meet a targeted volume specifically ordered for each individual patient and based on the patient’s physiological state. See study below:

Magdy, D.M., Metwally, A. Effect of average volume-assured pressure support treatment on health-related quality of life in COPD patients with chronic hypercapnic respiratory failure: a randomized trial. Respir Res 21, 64 (2020). https://doi.org/10.1186/s12931-020-1320-7
Requiring PCO2 = 52 puts rural patients who may not have access to facilities capable of completing ABGs at a significant disadvantage. ABGs are an invasive and often painful procedure. EtCO2 should be included as an acceptable option for estimating the patient’s hypercapnic state for both RAD and HMV criteria. See study below:
Defilippis V, D'Antini D, Cinnella G, Dambrosio M, Schiraldi F, Procacci V. End-tidal arterial CO2 partial pressure gradient in patients with severe hypercapnia undergoing noninvasive ventilation. Open Access Emerg Med. 2013 Jun 19;5:1-7. doi: 10.2147/OAEM.S43070. PMID: 27147867; PMCID: PMC4806812.

PFTs should be included as an acceptable alternative to PCO2, showing the decrease in specific lung functions which can be measured non-invasively and trended over time. PFT results are already widely accepted in criteria for RAD and HMV in Neuromuscular patients as well as OHS patients. PFTs are utilized for a wide range of pulmonary diagnosis and used to guide treatment and measure results.

Classification of Stable COPD should include the option of a normal pH (7.35-7.45) indicating a normal acid-base balance along with an elevated HCO3- and elevated PCO2 as an indication of a stable chronic COPD state.

Thank you for your consideration,

Joni Cazee, CRT
Respiratory Therapy Manager
Williams Brothers Healthcare Pharmacy

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The proposed rule does not address patients currently on therapy – either the RAD or HMV. Given that most of these patients have achieved therapeutic benefits for years and are normalized on the therapy, I would suggest grandfathering these patients from the new requirements in the proposed NCD. Adding new requirements to patients in a stable therapy will cause many to fall off which will certainly increase the number of acute care admissions.

Also the proposed rule does not give any variance for usage as current PAP and RAD policy does: 70% of usage for 4 hours or more in a 30 day period to achieve compliance to therapy. By not allowing the usage variance from 100%, new patients to the therapy will struggle with adherence simply because of initial discomfort for many. The requirement of 5 hours per 24-hour period appears arbitrary and out of sync with current industry standards. Requiring 5 hours instead of 4 and not allowing a 30% variance in a 30-day period will add a layer of complexity to all involved in the direct care of the patient which could potentially disrupt patient therapy.

The continued use criteria for the RAD does not indicate the methodology for measuring either normalization or reduction of PaCO2 from the baseline. It would be extremely difficult to achieve these measurements using ABGs every 6 months. Would VBG or EtCO2 be acceptable measurements for continuing usage?

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CMS suggested new coverage requirement comments:

-If changes are made, can CMS please consider grandfathering in the current pts on service?

-We have many patients that are home bound and have difficulty getting out to see a Dr, let alone every 6 months to continue with NIV therapy, could CMS allow for video dr appts if this goes through? Pulmonary dr offices wait time for an appt can be more than 30 days to get scheduled.

- we have a lot of rural area patients – they sometimes have to go to a city to get to the pulmonary Dr and the PCP’s don’t really know how to care for these pts on the NIV.

-the ABG requirement post set up is going to be difficult also, the patient needs an Rx to get these done, they can be painful and are a higher risk for arterial draw versus venous blood draw and then they cannot go to a lab to get this one done, it has to be completed at the hospital and they are not inpatient so it may be difficult to get that scheduled. Can it be documented as symptoms, instead of ABG – brain fog, confusion, lethargy, ect.

- increasing the minimal use to 5 hours for compliance can be a good thing for the patient health, but most of these patients have difficulty using it 4 hours as they don’t sleep for long periods of time and there can be a struggle to get the patient to use it during the day because that does not promote mobility and we know that COPD patients do better when they are more mobile.

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The ONMAP TEP appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo for “Noninvasive Positive Pressure Ventilation in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD (CAG-00465N).”

The ONMAP TEP emerged from the Virtual Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on July 22, 2020, assembled by the Centers for Medicare & Medicaid Services (CMS). The MEDCAC Panel reviewed the evidence specific to the home use of noninvasive positive pressure ventilation by patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). There was prevailing evidence that Medicare beneficiaries with COPD were not receiving the right devices for optimal benefit.

In addition, the experts convened at the meeting felt there were regulatory barriers further constricting access to appropriate care that required urgent attention. Conversation with CMS officials after the meeting made them aware of the great concern from the experts convened at the meeting that other critical issues and patient populations including patients with Complicated Obstructive Sleep Apnea, Hypoventilation Syndromes, Central Sleep Apnea, and Restrictive Lung Diseases required reconsideration. CMS officials also indicated that this level of review would require review from a technical expert panel, and we subsequently offered to assemble such a group.

The ONMAP TEP initial meeting organized by the American College of Chest Physicians in October 2020 assembled twenty-seven of the nation’s most widely acclaimed experts. This led to the eventual peer reviewed publications with detailed recommendations (P Gay, R Owens. ONMAP TEP Executive Summary CHEST 2021). For the purposes of this discussion, this included a specific subcommittee addressing recommendations for the COPD patients (N Hill, G Criner ONMAP: Patients With COPD CHEST 2021).

The ONMAP TEP chairs specifically appreciate that CMS has proposed an updated national coverage analysis (NCA) and revisions to the National Coverage Determination (NCD) based on the reconsideration request submitted by the ONMAP TEP. At the outset, we specifically praise the efforts that we expect to advance evidence-based treatment that will lead to optimized outcomes in the management of chronic respiratory failure due to COPD. Most notable in the proposed divisions include the following:

• Establishment of a clear pathway to a bilevel positive airway pressure (BPAP) device with a backup rate, for BOTH patients initiating therapy in the clinic or on discharge from the hospital.
• Addition of a clear pathway to home mechanical ventilation (HMV), for BOTH patients in the clinic and on hospital discharge.
• Adjustment of the initial period of adherence evaluation to 180 days. The additional time is essential to achieve the higher pressures and backup respiratory rate that define high intensity therapy. This is critical given that the prior clinical trials often hospitalized patients for > 5 days to acclimate patients more rapidly to settings believed necessary to stabilize or reduce carbon dioxide levels.
• Elimination of the need for overnight oximetry.
• Continuation of the existing policy that no formal sleep testing is required for qualification.
• Allow for provision of additional interface (mask), if daytime ventilation is used.

The ONMAP TEP requests that CMS consider the suggested revisions from the ATS, AASM, and CHEST also submitted as we are in strong agreement with those most particularly with the added comments from the AASM an ATS. We feel these are critical to ensuring patient access to care and optimizing outcomes. To complement our comments below, we have supplemented the proposed revisions in the commentaries with the line-item changes to the draft NCD. We do this in hopes that it may clarify our perception of the recommended changes and facilitate the creation of the final NCD for CMS officials.

Finally, the chairs of the TEP understand the wording in section D stating that the NCD decision summary is exclusively related to COPD. However, we take particular note that Section D later states that “all other indications for RADS and HMV... will be made by local Medicare administrative contractors,” which we feel is of critical importance for the ONMAP TEP. Implicit in this statement is first, the fact that the LCD reconsideration for COPD must be imminent. Secondly, we ask that the CMS office assist as possible to encourage the MACs to address COPD changes AND additional indications for RADS and HMV for patients with other medical conditions. This includes Medicare beneficiaries suffering from suboptimal access to equipment particularly for Hypoventilation Syndromes and Restrictive Lung diseases. This again has all been well documented by the ONMAP TEP publications previously cited. The efforts put forth by CMS with the current COD NCD reconsideration will serve as a well-constructed template for the other disease conditions requiring critical attention. The process outlined therein of determining criteria for initial and continued coverage for both RAD and HMV devices is excellent. This contains a concise and more simplified model to apply throughout and will lend very well to consistent and more easily understandable reimbursement criteria. Physicians will again be able to concentrate on being caregivers rather than burdened by deciphering coverage language followed by extensive documentation requirements. We the chairs of the ONMAP TEP are most grateful that CMS has taken this initial step.

Peter C Gay and Robert L Owens
Co-Chairs ONMAP TEP

References

1. Peter C. Gay and Robert L Owens. 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; 160(5):1808-1821
2. Nicholas S Hill, Gerard J Criner 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.

Recommended Revisions for Reconsideration

Decision Summary

A. General

Respiratory assist devices (RADs) with bi-level capability, with or without a backup rate feature, are devices that use a non-invasive interface (mask) to deliver a higher level of airway pressure when the patient inhales than when the patient exhales. A backup rate feature enables the device to provide a prespecified respiratory rate if the patient’s spontaneous respiratory rate decreases below a set number.

Compared with RADs, home mechanical ventilators typically have additional ventilatory modes, monitoring, ventilator control, and safety, alarm, and backup power features (batteries).

B. Proposed Nationally Covered Indications

The Centers for Medicare & Medicaid Services (CMS) proposes to cover a RAD with backup rate feature in the home to deliver high intensity noninvasive ventilation (NIV) as treatment for an individual with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). A RAD with backup rate feature must be utilized with the intention of providing in the high intensity mode therapy (IPAP > 20 cm H2O and backup respiratory rate of at least 14 breaths per minute).. A RAD with backup rate feature is covered in the home for an initial 180-day period for individuals with COPD when all the following criteria are met:

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 = 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia (as determined and documented by the treating clinician; no sleep testing is required);
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist, and
• The individual demonstrates one of the following characteristics:
  • Stable COPD as determined and documented by the treating clinician, without defined as no increase in or new onset of more than one respiratory symptom (cough, sputum production, sputum purulence, wheezing, or dyspnea) lasting 2 or more days and no change of pharmacological treatment during the 24-week period before initiation of NIV, or
  • Persistent hHypercapnia present for at least 2 weeks post hospitalization after resolution of an exacerbation of COPD requiring acute NIV.

CMS proposes to cover a RAD without backup rate feature for an individual with CRF consequent to COPD who cannot tolerate high intensity NIV or for whom the backup rate feature is otherwise medically inappropriate. (High intensity continuation minimum defined as IPAP > or = 15 cmH2O and backup respiratory rate of at least 14 breaths per minute). A RAD without backup rate feature is covered in the home for an initial 180-day period for individuals with COPD when all of the following criteria are met:

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia (as determined and documented by the treating clinician; no sleep testing is required)
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist.

CMS proposes that individuals receiving initial coverage for a RAD as described in (i), (ii) or (iii) above must be re-evaluated by day 180 after receiving a RAD, and at least every once 6 months thereafterlater, to establish that continued coverage by Medicare beyond the first 180-days and continued for another 180 days is medically necessary. Medicare will not continue coverage into the 7th and succeeding months of therapy until the required re-evaluation is performed and establishes that continued coverage is medically necessary.

During a re-evaluation to establish that continued coverage is medically necessary, the practitioner must evaluate and verify that all the following usage requirements are achieved by the beneficiary in order to continue coverage of the device:

• Consistent use of the device for an average of at least 5 hours per 24-hour period 4 hours per day on 70% of days within a 30 day period, and
• One or more of the following clinical outcomes has been achieved:
  • a normalization of PaCO2 (< 45 mmHg) or stabilization (current PaCO2 level is no worse than baseline), or
  • a 20% reduction in PaCO2 from baseline value, or
  • a reduction in COPD exacerbations requiring hospitalization due, at least in part, to device usage, or
  • an improvement of at least one of the following patient symptoms associated with chronic hypercapnia:
    • headache
    • fatigue
    • shortness of breath
    • confusion
    • sleep quality

Note, as described in (i) above, a RAD with backup rate feature must be utilized in the high with the intention of providing high intensity mode therapy (IPAP > or = 15 20 cm H2O and backup respiratory rate of at least 14 breaths per minute).

CMS proposes to cover a home mechanical ventilator (HMV) used in a volume targeted mode with the intent to provide high intensity therapy as treatment for an individual with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD) who exhibits certain clinical characteristics.

• The individual exhibits persistent hypercapnia as demonstrated by PaCO2 = 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2;
• Sleep apnea is not the predominant cause of the hypercapnia (as determined and documented by the treating clinician; no sleep testing is required);
• The individual exhibits the physical and cognitive ability to support home ventilation or has a caregiver who can assist; and
• The individual demonstrates at least one of the following characteristics:
  • Requires oxygen therapy at an FiO2 ≥36% or ≥ 4L nasally, or
  • Requires ventilatory support for more than 8 hours per 24-hour period, 70% of the time within a 30 day period, or
  • Requires the alarms and internal battery of an HMV, because the patient is unable to effectively breathe on their own for more than a few hours and the unrecognized interruption of ventilatory support is likely to cause a life-threatening condition if the patient or caregiver cannot be otherwise alerted as documented by the treating clinician, or
  • None of the below are likely to be achieved with consistent use of a RAD with backup rate feature for 45 hours per 24 hour period day 70% of the time within a 30 day during an adequate trial period because the patient’s inspiratory pressure needs exceed the capabilities of a RAD as justified by the patient’s medical condition:
    • Normalization (PaCO2 < 45 mmHg) or stabilization (PaCO2 no higher than baseline on initiation or at Hospital discharge) of PaCO2, or
      • a 20% reduction in PaCO2 from baseline value, or
      • a reduction in COPD exacerbations requiring hospitalization due, at least in part, to device usage has occurred, or
      • an improvement of at least one of the following patient symptoms associated with chronic hypercapnia:
        • headache
        • fatigue
        • shortness of breath
        • confusion
        • sleep quality

CMS proposes to cover an HMV used in a volume targeted mode immediately upon hospital discharge for an initial 180-day period for individuals with acute on chronic respiratory failure due to COPD if the beneficiary’s needs exceeded the capabilities of a RAD (with or without backup rate feature) and required usage of a ventilator within the 24-hour period prior to hospital discharge to avoid rapid symptom exacerbation or rise in PaCO2 as determined and documented by the treating clinician.

CMS proposes that individuals receiving coverage for an HMV as described in (i) and (ii) above must be re-evaluated by day 180 after receiving an HMV, and at least every 126 months following the initial usage, to establish that continued coverage by Medicare beyond the first 180-days is medical necessity. Medicare will not continue coverage into the 7th and succeeding months of therapy until the required re-evaluation is performed and establishes that continued coverage is medically necessary.

During a re-evaluation to establish that continued coverage is medically necessary, the practitioner must evaluate and verify that the HMV has been used for an average of at least 45 hours per 24-hour period day 70% of the time within a 30 day period in order to continue coverage of the device.

C. Nationally Non-Covered Indications

N/A

D. Other

Coverage of all other indications for RADs and HMVs used in the treatment of COPD, including subsequent attempts at their usage, not otherwise specified above as covered or non-covered, will be made by local Medicare Administrative Contractors under section 1862(a)(1)(A) of the Act.

See Appendix A for the proposed manual language.

Additionally, we propose to make conforming changes in Section 280.1 (Durable Medical Equipment List) of the National Coverage Determinations (NCD) Manual to add a cross reference to new NCD Section 240.9 (NIPPV in the Home for the Treatment of CRF Consequent to COPD).

CMS is seeking comments on our proposed decision pursuant to §1862(l)(3)(B) of the Act.

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As a hospital based DME we have many COPD patients that could be impacted by the proposed changes. It is up to this body to decide if the impact will be positive or negative. The way the current policy is written we see the potential for this policy to have a negative impact if not thought out properly. We have several concerns with the way the policy is currently written.

1. Allowing for the inclusion of Venous Blood Gas (VBG) and End-Tidal CO2 (EtCO2) testing would be beneficial, especially in outpatient settings. 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.

2. We disagree with the criteria of (High intensity pressure of over 20) for RAD with a rate. This can be very aggressive for patient's that need a rate to reduce pco2 but are unable to tolerate higher pressures. Patients with COPD are extremely frail and are normally not able to tolerate higher pressures. The pressure and rate need to be tailored to the patient's needs and shown by a reduction of symptoms. Higher pressures do not equal a higher tidal volume or minute ventilation for every patient.

3. The proposed initial coverage range and subsequent re-evaluation every 180 days will be unrealistic for most COPD patients. This is especially true in todays healthcare climate where access to provider appointments is limited as specialty providers are already overtaxed and unable to see all of the patients that need care in a timely manner. Having patient's be re-evaluated every 6 months will be difficult at best, especially if Tele-Health visits are no longer a viable option after September of 2025.

Thank you for your consideration.

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Title: Chief Medical Officer
Organization: React Health
Date: 4/8/2027
RE: Comment on proposed NCD, Submitted: CMS.gov
Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

React Health is a U.S.-based healthcare manufacturer with a robust portfolio in Sleep, Ventilation, Connectivity, and Oxygen products. Our Chief Medical Officer, Dr. Colleen Lance, MD, brings over three decades of patient care experience, with the past twenty-five years focused on sleep medicine and noninvasive positive pressure ventilation (NIPPV). Her background includes leadership roles as medical director for home medical equipment providers and service on committees at the American Academy of Sleep Medicine, including the Payor Policy Review Committee prior to her time with React Health.

We commend CMS for its efforts to revise the National Coverage Determination (NCD) for NIPPV in chronic respiratory failure (CRF) due to Chronic Obstructive Pulmonary Disease (COPD). Notably, the removal of requirements for hypoxemia documentation, pulmonary function testing, polysomnography, and overnight oximetry signifies progress toward reducing barriers to essential therapy. However, several proposed provisions could significantly delay or limit access to life-saving interventions.

Reducing the time to treatment for patients with COPD-CRF is known to reduce mortality, but only if initiated in the first 30 days after diagnosis, with mortality rate reduction benefit decreasing after the first 7 days after diagnosis (Frazier et al., 2022). Overall Medicare expenditures have significant reduction if therapy is initiated in the first 15 days after diagnosis, with the largest savings if initiated in the first 7 days (Frazier et al., 2022). The NCD in its current form would result in increased time to or an absence of life-saving treatment. The following are points in the revised NCD that lack compelling evidence, and would increase burden on patients, providers, and home medical equipment companies (HMEs).

1. 5-Hour Nightly Use Requirement
The proposed adherence threshold of 5 hours per night is based on protocol stipulations in prior studies (Köhnlein et al., 2014; Clini et al., 2002) rather than real-world outcomes. This rigid threshold does not account for the high degree of sleep disruption, nor the degree sleep variability experienced by COPD patients with nightly sleep durations ranging from 3.4 to 6.73 hours (Klink & Quan, 1987; Cormick et al., 1986; Budhiraja et al., 2012). The presumed requirement of 100% of nights for adherence fails to reflect the variability seen in real-world patient behavior and stands in contrast to adherence rates for COPD pharmacotherapy, which range from 10% to 40%. (Hometowska et al., 2022). The proposed adherence metric lacks clinical practicality and fairness where a flexible outcomes-based approach is warranted.

2. High-Intensity Therapy
ATS guidelines emphasize the low certainty of evidence supporting high-intensity NIPPV aimed at normalizing CO2 (Macrea et al., 2020). Prescribing minimum IPAP > 20 cm H2O and respiratory rate of at least 14 breaths/min risks intolerance, asynchrony, and ineffective ventilation (Fanfulla et al., 2007). Multiple studies demonstrate that significant CO2 reduction can be achieved using lower pressures (Hatipoglu et al., 2024; Struik et al., 2014; Jiang et al., 2024). A bilevel device without backup rate as the proposed solution to intolerance of high-intensity therapy is an inadequate solution. An individualized, tolerance-based approach to therapy is recommended.

3. Arterial Blood Gas Testing (ABG)
ABG testing presents logistical challenges, particularly in rural or underserved areas, and lacks consistent evidence of clinical utility in this context (Macrea et al., 2020). Patients admitted with PaCO2 levels > 60 mmHg may not show improvement in CO2 levels after 12 months of therapy (Hatipoglu et al., 2024), raising further questions about the rationale for CO2 reduction or normalization as a criterion for continued care.

4. Clarification
The NCD should clarify that home mechanical ventilation (HMV) may be prescribed as the initial therapy when clinically indicated. Any implication of mandatory step therapy or trial periods with bilevel devices is inappropriate and may lead to treatment delays and increased morbidity. Further clarification is needed regarding the term “volume targeted mode” for HMV at the time of discharge as this may have various interpretation, making the use of standardized terminology helpful. Clinical discretion should guide mode selection as there is no compelling data in the literature comparing modes. Note is made that three of the studies cited in the NCD were prescribed pressure-controlled mode (Köhnlein et al., 2014; Struik et al., 2014; Murphy et al., 2017).

5. Logistical considerations
Mandating the use of the same device 24 hours pre-discharge imposes undue strain on institutions with limited inventories, prolonging hospital stays and increasing costs. Moreover, reevaluation every 180 days with ABG as a core component, exacerbates system burdens, especially in regions with limited healthcare infrastructure (Chatterjee, 2022). Providers must be afforded latitude in prescribing devices compatible with available home support, and noninvasive CO2 monitoring methods should be accepted for reassessment purposes.

The proposed NCD also places an inordinate burden on home medical equipment providers (HMEs), particularly in managing the reevaluation process. HMEs are responsible for significant administrative duties, including managing documentation, coordinating with provider offices, and maintaining communication with patients. Furthermore, the process of retrieving and reissuing devices for patients who do not meet onerous reevaluation criteria is wasteful and counterproductive, especially for a progressive disease like COPD that will only worsen.

Recommendations
To optimize access to care and reduce administrative burdens, we respectfully urge CMS to:

Encore Healthcare and Zach Gantt, RRT, FAARC, respectfully submit the following comments in response to the Centers for Medicare & Medicaid Services (CMS) proposed National Coverage Determination (NCD) for Home Mechanical Ventilation (HMV). While we appreciate CMS’ intent to standardize access to noninvasive ventilation (NIV) and align policy with current clinical evidence, we believe the draft policy, as written, relies on a narrow and incomplete interpretation of the literature, introduces unclear and sometimes contradictory clinical criteria, and creates operational challenges to Providers that do not reflect the realities of care delivery in the home setting.

As a nationally recognized provider of technology-enabled respiratory care solutions, Encore Healthcare software currently manages over 40,000 patients with chronic respiratory conditions, particularly those with Chronic Respiratory Failure (CRF) due to Chronic Obstructive Pulmonary Disease (COPD). Based on our clinical experience and outcomes data over 7 years and 137,000 patients, we are deeply concerned that the proposed policy, if implemented without meaningful revisions, could lead to the following unintended consequences:

1. Disruption of Care for Current Patients: Many beneficiaries who are stable and dependent on NIV or HMV may no longer meet qualification requirements under the proposed criteria, potentially resulting in interruptions to life-sustaining therapy.

2. Upward Pressure on Medicare Spending: By narrowing access to proven, cost-effective home ventilation with in-home access to respiratory therapists as part of the frequently serviced category, the policy would very likely increase acute care utilization, including emergency department visits and hospital admissions for respiratory decompensation.

3. Misalignment with Clinical Practice Standards: Some proposed pathways imply a stepped approach to therapy (e.g., requiring failure on bilevel devices before initiating HMV), which contradicts standard medical practice, physician judgment, and the intended use of FDA-cleared devices.

4. Operational Complexity for Providers and Suppliers: The combination of vague definitions, increased documentation burdens, and limited guidance on implementation is likely to generate confusion and administrative delays for both prescribers and durable medical equipment (DME) suppliers.

The comments that follow are organized into three core areas of concern:

I. Risk to Patients and Access to Care

II. Challenges to Practical Implementation

III. Compliance and Documentation Implications

We respectfully urge CMS to consider a delay in implementation to allow for thoughtful revision, further stakeholder input, and alignment with best practices in respiratory care. Our recommendations are intended to support the development of a policy that both preserves access for vulnerable patients and enables sustainable, clinically sound service delivery by the HME community.

I. Risk to Patients / Access to Care

As a respiratory disease management organization dedicated to patient outcomes, Encore Healthcare is deeply concerned that the proposed NCA, as drafted, poses serious and immediate risks to Medicare beneficiaries, particularly those with Chronic Respiratory Failure (CRF) due to COPD. These patients are among the most vulnerable in the Medicare population. They deserve coverage policies that reflect clinical realities and do not impose arbitrary thresholds that compromise access to essential care.

A. Arbitrary Clinical Criteria Create Barriers to Life-Saving Therapy
-The requirement that a patient must demonstrate a PaCO2 = 52 mmHg via arterial blood gas (ABG) testing is overly prescriptive, especially when alternative, less invasive, and clinically accepted tests such as venous blood gas (VBG), end-tidal CO2 (ETCO2), and transcutaneous CO2 (TcCO2) exist and are regularly used in clinical practice. Requiring ABGs every six months imposes unnecessary procedural risk and increased cost to both the patient and the system. Many of these tests must be conducted in hospital settings—not primary care—causing access inequities for rural and underserved patients.

B. Reevaluation Every 6 Months is Logistically and Financially Impractical
-Requiring a clinical re-evaluation every six months—especially including invasive testing and documentation—will impose substantial barriers for patients who may already struggle with mobility, transportation, and caregiver access. Many Medicare beneficiaries are homebound, live in rural areas (25% of E0466 Beneficiaries), or lack access to pulmonology specialists. This reevaluation requirement may lead to therapy interruption, hospital readmissions, and worsening of chronic disease.

C. Lack of Grandfathering Puts Thousands at Risk
-The failure to grandfather existing NIV patients who are stable and benefiting from their therapy risks massive disruptions in continuity of care. Encore Healthcare manages thousands of patients across the country who are thriving with NIV. Forcing these individuals to requalify under new, more burdensome criteria will almost certainly result in therapy discontinuation, exacerbation of symptoms, and higher healthcare utilization.

D. Poorly Defined Access Pathways Post-Hospital Discharge
- The proposed policy restricts post-hospital initiation of NIV to only those who used a device within the 24 hours prior to discharge. This not only ignores standard discharge planning practices but also jeopardizes safe transitions to the home. In many cases, inpatient devices and home equipment differ. Requiring one to match the other lacks clinical justification and removes physician discretion.

II. Inability to Operationalize by the HME Community

Encore Healthcare works in close partnership with HME suppliers and understands the operational realities of delivering high-quality care in the home. The proposed policy includes requirements that are unworkable, will strain an already overburdened HME infrastructure, and could unintentionally shut down access due to logistical and cost constraints.

A. Compliance Monitoring Not Supported by Device Capabilities
-The requirement that suppliers verify an average use of 5 hours per 24-hour period is not supported by current NIV device technology. Most devices do not report average daily use over time, and certainly not in a format aligned with CMS’ proposed compliance standards. Additionally, the proposal lacks clarity around how usage should be calculated (e.g., best 30 days? rolling average?). This ambiguity makes enforcement inconsistent and legally risky for providers. Modem connectivity is difficult in some areas; for example in Alabama in 1Q25 only 42.8% of the vents were connected via modem.

B. Unfunded Mandates Will Dismantle Respiratory Programs
-The post-cap rental requirements will force suppliers to provide ongoing clinical support, troubleshooting, and documentation—without reimbursement. Encore has extensive experience supporting patients on long-term therapy and can confirm that sustaining high-level respiratory care post-13-month cap demands significant resources (clinical staff, software, compliance monitoring, communication with physicians). Without reimbursement for these services, many suppliers will exit the NIV space entirely, collapsing access in some regions.

C. Documentation Requirements Extend Beyond Supplier Capabilities
-The policy places unreasonable burdens on DME suppliers to collect and verify clinical outcomes—PaCO2 reduction, symptom resolution, hospitalization data—which they do not generate or control. Unlike hospitals or physician practices, DMEs lack real-time access to EHRs or lab systems. Expecting them to validate medical necessity based on external metrics is administratively infeasible.

D. Conflicting Criteria Add to Operational Chaos
-The policy contains inconsistencies between the initial coverage criteria and post-discharge qualifications, particularly around timing (e.g., 2-week post-exacerbation delay vs. 24-hour discharge device use). These inconsistencies will confuse prescribers, delay therapy, and increase the risk of claim denials due to policy misinterpretation.

E. FDA guidelines not being met by CMS policy
-Moving from RAD with backup rate to RAD without backup rate after failure due to high intensity therapy is not appropriate and is against FDA 510k approval of use on RAD E0470 devices. These devices are designed for sleep apnea and respiratory insufficiency, not ongoing treatment of Respiratory Failure.

III. Compliance / Utilization

Encore Healthcare is a nationally recognized leader in respiratory therapy adherence and outcomes tracking. Through partnerships with payers and providers, we have demonstrated that personalized care plans and flexible compliance metrics yield the best patient outcomes. The proposed NCA’s rigid, one-size-fits-all compliance model is deeply flawed.

A. Five-Hour Minimum Usage is Arbitrary and Not Supported by Clinical Data
-The 5-hour/day usage requirement lacks support in peer-reviewed research. Even in the four RCTs cited by CMS, up to 50% of patients used therapy for less than 5 hours per night and still saw clinical benefits. There is no validated evidence that 5 hours is a “magic number” for clinical efficacy in COPD-CRF.
-The 4 hours on 70% of nights metric (used for CPAP/RAD) is more feasible and aligned with industry experience and manufacturers' web-based software compliance algorithms. This metric also accounts for individual variability and allows providers to develop customized adherence interventions, especially in patients with comorbidities or those new to therapy.

B. Reevaluation Every Six Months is Excessive and Will Erode Utilization
-The frequent reevaluation requirement will result in care disruptions when appointments cannot be scheduled in time, especially for rural or high-needs patients. Missed reevaluations will trigger non-coverage, requiring DME providers to retrieve life-sustaining devices. This compliance cliff is ethically and clinically unacceptable.
-Annual reevaluation is sufficient and consistent with other DME policies. Telehealth should be explicitly allowed to reduce access barriers.

C. Overemphasis on Outcomes Metrics Ignores Patient Complexity
- The policy’s focus on outcomes like reduced exacerbations, improved symptoms, or specific PaCO2 thresholds fails to account for the unpredictable progression of COPD. Patients may not show textbook improvements, but still rely on NIV for stability and symptom control. These metrics also lack baseline references and are not routinely captured or standardized in clinical practice.
- For example, a patient whose symptoms worsen due to disease progression may still need NIV to prevent hospitalization. Removing therapy because a symptom worsens, without physician discretion, is counter to standard clinical care.

Closing Remarks
Encore Healthcare and Zach Gantt, RRT, FAARC urge CMS to substantially revise the proposed NCA to align with clinical best practices, ensure sustainable operations for the HME community, and protect access to essential therapy for the patients who need it most.

Key Recommendations:
1. Grandfather all current NIV patients to avoid life-threatening disruptions.
2. Remove the ABG-only requirement and allow alternative, less invasive CO2 testing.
3. Eliminate the 5-hour/day average usage rule in favor of existing CPAP-style metrics.
4. Move to annual reevaluations instead of every six months.
5. Ensure DME suppliers are not financially responsible post-cap rental without reimbursement mechanisms.
6. Allow physician discretion in setting and selecting the device modality, including RAD with backup rate, high-intensity NIV, and HMV modes.

We would happily discuss these concerns further and offer insights from our data and patient experiences.

Sincerely,
Zach Gantt, RRT, FAARC
President & CEO
Encore Healthcare

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Thoughts regarding new CMS proposed requirements for NIV and RAD. Although I can see the need to request these additional requirements, I have some concerns for our patients. I feel some of the proposed requirements are creating additional barriers for these already fragile patients.

RE: Centers for Medicare and Medicaid Services (CMS) regarding the proposed National Coverage Analysis (NCA) on Noninvasive Positive Pressure Ventilation (NIPPV) in the Home (CAG-00465N).

As a Respiratory Director and Respiratory Therapist with over 20 years of experience in acute, post-acute, and population health, specifically focusing on COPD and Chronic Respiratory Failure (CRF), I both appreciate the opportunity for public comment and have significant concerns about certain aspects of the proposed policy. I am particularly pleased to see the removal of the oximetry testing requirements, which will allow physicians more autonomy when prescribing RAD devices. However, I have several concerns regarding language that is either overly vague or prescriptive, resulting in requirements that are nearly impossible to comply with and will likely create serious barriers to patient access.

Summary of Requested Revisions:
-Removal of the requirement for PaCO2 = 52 mmHg
-Clarification or removal of the language stating “sleep apnea is not the predominant cause of the hypercapnia”
-Inclusion of alternative testing methods (e.g., VBG, EtCO2, TcCO2, and PFT) for qualifying and monitoring therapy
-Removal of the two-week waiting period to validate “persistent hypercapnia” before initiating services or treatment
-Removal of prescriptive language such as “high intensity therapy,” specific pressure or breath rate requirements, and minimum use requirements
-Removal of the six-month reevaluation period and requalification language
-Removal of FiO2 requirements under the HMV provision section
-Request that existing patients receiving these services are “grandfathered” and not required to requalify or limit access to service

Key Concerns and Detailed Explanations:
-Re-evaluation Frequency: The proposed six-month re-evaluation frequency is impractical and burdensome, particularly for patients in rural areas. Annual recertification, with face-to-face documentation via in-person or telehealth visits, should be sufficient and in line with other CMS policies.
-Arterial Blood Gas (ABG) Testing: ABG testing is invasive, painful, and not widely available, this is not limited to rural areas, but is true for metropolitan areas as well. Alternative, less invasive tests such as VBG, EtCO2, or transcutaneous CO2, or PFT should be accepted as viable alternatives. Requiring repeated ABG testing every six months adds unnecessary burden, particularly for chronically ill patients. COPD does not disappear, but rather worsens, any improvement in CO2 levels would be a direct correlation to the therapy benefits.
-Pulmonary Function Tests (PFTs): PFTs, including spirometry, are vital and accessible for diagnosing and managing COPD and assessing the likelihood of hypercapnia. They should be used alongside clinical assessment and other tests outside of or in addition to ABG’s
-PaCO2 Levels: Setting a strict PaCO2 threshold of = 52 mmHg for NIPPV therapy initiation and continuation is arbitrary and does not reflect clinical evidence. Studies have shown benefits for chronic hypercapnia treatment even with lower PaCO2 levels, and restrictive thresholds could limit access to necessary therapy.
-Removal of FiO2 Requirements: Not all COPD/CRF patients need >4 L/min oxygen. Ventilation therapy should be based on the patient's ventilatory needs rather than arbitrary oxygen flow restrictions. The current devices also lack the capability to support higher oxygen flow, making such requirements impractical.
-Minimum Usage Requirements: Requiring an average of 5 hours of device use per day is unreasonable and unsupported by clinical evidence. Device usage varies, especially at the beginning of therapy, and this requirement should not be more stringent than current PAP compliance guidelines.
-Prescriptive Language: Restricting RAD devices with backup rates to patients unable to tolerate high pressures (e.g., IPAP > 20) is not clinically justified and could limit access to effective treatment options like VAPS, which is often preferred for COPD patients.

-Clarification on Sleep Apnea Diagnosis: We recommend that CMS clarify the policy to state that physicians can document the intent to use RAD/HMV for COPD treatment, not for OSA. Patients with both OSA and COPD/CRF should not be denied access to necessary therapy due to the presence of OSA. Sleep apnea, except in cases of Obesity Hypoventilation Syndrome, rarely causes hypercapnia, and the OSA-related exclusion criteria should be removed.
-RAD Use Upon Hospital Discharge: The requirement that patients must have used and benefited from an equivalent device within 24 hours of discharge creates undue burden and delays. Hospital devices are not equivalent to home devices, and this requirement should be replaced by language supporting provider expertise and clinical judgment.
-Waiting Periods: A 14-day waiting period after hospitalization before prescribing any ventilation therapy is unnecessary and could delay essential treatment. Additionally, requiring a four-week wait after pharmacological adjustments before initiating NIV/HMV is unreasonable and could lead to further decompensation and adverse outcomes.
-180-Day Follow-Up Guideline: The six-month follow-up guideline is an undue burden, particularly for patients in rural areas. We recommend a one-year follow-up with face-to-face or telehealth visits, in line with other CMS policies.
Additional Remarks:
CMS has relied on older studies and ignored more recent studies that utilize their own data sets, which demonstrate the benefits of early intervention with NIV therapy. The over-reliance on outdated studies based on the European healthcare model does not align with the care management process in the U.S. Additionally, recommendations in the proposed policy conflict with CMS’s other STAR goals for Medicare Advantage plans, such as optimizing medications and reducing readmissions. Physicians may face the dilemma of choosing between optimizing medication therapies or providing timely NIV to prevent readmission. Timely NIV/HMV use offers significant benefits to both patients and the healthcare system, providing cost savings and improving patient outcomes. This policy restricts the ability to provide advanced care in the home, contradicting industry trends toward "hospital-in-the-home" models and limiting care for the COPD population.

References:
-Centers for Medicare & Medicaid Services. (2023). 2025 Medicare Advantage and Part D Star Ratings. CMS.gov. https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-star-ratings
-Frazier WD, DaVanzo JE, Dobson A, Heath S, Mati K. (2022). 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, 200: 106920. https://doi.org/10.1016/j.rmed.2022.106920
-Hill NS, Criner GJ, Branson RD, Celli BR, MacIntyre NR, Sergew A; ONMAP Technical Expert Panel. (2021). Optimal NIV Medicare Access Promotion: Patients With COPD. Chest, 160(5): e389–e397. https://doi.org/10.1016/j.chest.2021.06.082
-Kaminska M, Rimmer KP, McKim DA, Nonoyama M, Giannouli E, Morrison DL, O’Connell C, Petrof BJ & Maltais F. (2021). Long-term non-invasive ventilation in patients with chronic obstructive pulmonary disease (COPD): 2021 Canadian Thoracic Society Clinical Practice Guideline update. Canadian Journal of Respiratory, Critical Care, and Sleep Medicine. https://doi.org/10.1080/24745332.2021.1911218
-Macrea M, Oczkowski S, Rochwerg B, Branson RD, Celli B, Coleman JM 3rd, et al. (2020). Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 202(4): e74–e87. https://doi.org/10.1164/rccm.202006-2382ST
-Nicolini A, Santo M, Ferrari-Bravo M, Barlascini C. (2014). Open-mouthpiece ventilation versus nasal mask ventilation in subjects with COPD exacerbation with mild to moderate acidosis: a randomized trial. Respiratory Care, 59(12): 1825–1831.
-Osadnik CR, Povey AJ, Ellis SJ, et al. (2024). Early home initiation of non-invasive ventilation in COPD patients with persistent hypercapnia: a real-world data analysis. BMC Pulmonary Medicine, 24, Article 151. https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03151-1

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1. Will existing patients be grandfathered in if they are currently using and benefitting from NIV/HMV. Taking away the therapy or transitioning them to a less advanced device would be detrimental to their health and potentially cause more frequent hospitalizations.
2. Will there be a retroactive continued coverage of services for a late FTF visits with timely satisfaction of usage/benefit requirements.
3. Regarding the below criteria. How many days over what period of time is considered sufficient evidence to satisfy "average usage" requirements?
   - Consistent use of the device for an average of at least 5 hours per 24-hour period,

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These new proposed requirements would be detrimental to patients diagnosed with CRF and COPD. To demand that patients re-evaluate every 6 months with an invasive ABG test makes it nigh impossible for patients to qualify for therapy that benefits their lives. It will be particularly difficult for patients that live in rural areas who travel great distances to visit their Pulmonologists, who often have appointment wait times of over 6 months.
NIV therapy has proven to be beneficial to patients with these diagnoses. Unlike standard BIPAP therapy, an NIV can be set to meet the individual patients needs, with multiple modes, and added benefit of more interface options available.
I hope these proposed changes will be reconsidered, and that the final decision will be in the spirit of benefiting these patients lives and well being.

Thank you

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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.

The proposed requirement that a repeat Arterial Blood Gas (ABG) must be obtained every 6 months as part of the re-evaluation – Strict qualifying criteria, such as requiring a painful and invasive ABG draw is unnecessary and burdensome for this chronically ill patient population. Excluding the use of other reliable and less invasive tests like VBG or ETCO2 will further limit access to care, particularly in rural areas lacking specialty facilities

The proposed requirement for a patient to utilize the therapy on average 5 hours per day – The requirement is not consistent with current clinical and industry standards and policies. The implementation of a new measure has the potential to disrupt patient care, especially considering the complexities of adoption that will be faced by suppliers and device manufacturers.

The proposed NCA does not specify that beneficiaries receiving RAD or HMV therapies prior to the effective date will be grandfathered — Patients already using these devices are unlikely to meet the new clinical coverage criteria required in the draft NCD. Moreover, if a physician/prescriber believes that the patient continues to benefit from the device, it would be inappropriate to remove the device from them and risk hospitalization and/or death. CMS must clarify that the new policy will only apply to beneficiaries with new dates of services.

Timely noninvasive ventilation treatment is crucial in ensuring patients are receiving the care that the need to live. Peer Reviewed studies and an April 2025 Dobson/Davanzo/Health Economist study show: The sooner a patient receives noninvasive ventilation treatment, (1) the lower the risk of death, (2) the less likely they are to be admitted to any inpatient setting, (3) the less likely they are to visit the American Association for Homecare

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There will be possible dramatic impacts of CMS proposed changes to NIPPV. First, I feel that this will cause increase costs associated with copays and out of pocket expenses for additional physician visit, lab work, and travel or transportation, especially for patients living in outlying areas. I think that scheduling will play a large factor, as many specialty physicians, like pulmonologists are scheduling out farther than 6 months, at the earliest. For those who do not drive themselves, this will cause complications getting transportation scheduled, and some to get insurance to accept some of the cost and for patients who are unable to leave home or are bed bound, this could pose complications in getting ambulette services more frequently and/or allowing visiting physicians time to meet the increased demand. This will also increase the chances of exposure to illness. The physicians’ offices are treating all types of patients, will all types of viruses & bacterial infections. Finally, ABGs for validation of benefit to the prescribed therapy can be obtained in a much less invasive manner, with End Tidal CO2 monitoring or venous blood gas draws. These are both adequate tests to monitor ongoing therapy.

I don’t know that making a change to 5 hours daily usage would offer any additional benefit, as I feel that RTs educate that therapeutically the patient would be best served if wearing the equipment for a full night sleep.

I do support that the beneficiaries receiving RAD or NIV prior should be grandfathered.

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I have been a therapist in critical care for 10 years and ABGs are an invasive procedure that shouldn't be done on a frequent or scheduled basis, aside from hospital treatment. I've only been in DME for a year and a half but this one rule or standard being place on patients who need the therapy at home is very extreme to me. First a lot of doctors' offices aren't able to schedule that far in advance or they are booked farther out then 6 months so it would make it hard for patients to get scheduled exactly 6 months at a time. Second what about the patients who have physicians or pulmonologists out of town or even state, it would be hard for them to physically travel every 6 months or even to afford a trip every 6 months just for a checkup. Third and I believe this is the most important is this could actually delay or stop patient care and that is a huge no to me as a medical professional.

I could go on and on about why this suggested idea could negatively impact our patients, but it is our job as medical professionals to advocate for our patients!

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egarding the proposed changes to the NIPPV Coverage Criteria, Testing, Re-evaluations, and Device Selections. I have the following comments and advise that this policy should seriously be reconsidered.

1. The Policy does not specify whether or not certain beneficiaries that are currently receiving the NIV therapies prior to the effective date will be grandfathered in. They must be. The impact to thousands of COPD patients lives will be at risk as they are unable to be tested, see their MD's, undergo ABG in-hospital testings, may not qualify and subject to collections, they would be responsible for their ventilators, equipment will be pulled from their homes, their oxygen tied in to their ventilation would be compromised.

2. The request to perform repeated Arterial Blood Gas (ABG) every 6 months as part of re-evaluation is unnecessary and very invasive for our COPD patients especially for our rural patients lacking hospitals or other specialty faciltieis. ABG's can rarely be done in the doctors offices or Labs.

3. Finally, the proposed requirement for a patient to utilize therapy for 5 hours a day on average is not consistent with industry standards. For example, PAP therapy is greater than and equal to 4 hours per night on 70% of the nights and for a 30 day period. This also has a potential to disrupt patient care, especially considering that much of this equipment does not have modems from many of the manufacturers available.

Thank you for your serious consideration to modify this criteria and to NOT create patient harm.

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My first instinct, as with most practitioners with big hearts, is how can we help the patient. How can we make things easier for them? Healthcare was hard for us in our programs so that we could make healthcare easier for others. By having patients have to acquire not just an ABG, sounds simple to anyone who doesn’t work in the medical field. But it’s not that simple. Patients must get approved for a doctors appt, then get the order, then hopefully can drive to said place for the order (which is usually a hospital), then sit through a painful and invasive procedure, then repeats the process back home, then waits for results to get back to their doctor who then hopefully has enough time to write the RX for machines that the patient desperately needs, then DME companies receive it, review it… this is a long process. A solution to this would be 1) to listen to the advice all LICENSED practitioners have since they’ve been to school for years for this exact thing 2) instead of ABG which is only needed to assess oxygen levels, let’s do a VBG as venous blood is a small amount worth of a difference in results. Since CO2 is the main focal point, oxygen levels do not matter if that’s not what you’re measuring. Now some doctors, may be very particular over that small difference, but again we all need to be asking ourselves “what’s best for the patient?” And we all need to keep in mind our medical oaths to do no harm. Why go out of our way to cause a patient harm when we can get accurate numbers on our patient in other ways? It is far easier for a patient to go to an outpatient clinic to get venous lab draws and have a VBG be a part of that. There’s more nurses in clinics to facilitate that than there are RTs. Why cost our sick patients yet another hospital bill? By making ABG results mandatory, we are DELAYING our patients their care. How can we call ourselves healthcare professionals by doing this? We should be advocating for our patients and being their voice now to make their future easier. Some patients who even have access to quick medical care still refuse to go since they know the routine of difficulty breathing in the ER: constant breathing Tx’s, ABGs sometimes 2 or 3 within an hour, strapped to the BiPAP with the feeling of suffocation and if it’s really intense, intubation… by delaying patient care, our actions could lead a patient to be apathetic in seeking care knowing this would be their fate in the ER. Why would we put patients in this situation. Patients are first always, are you as an organization putting them first? Do you have the clinical knowledge and understanding to be speaking FOR medical professionals and are you prepared to carry that weight if your protocol results in more patient harm? Is what you’re proposing MORE beneficial to the patient? Are you allowing yourself to be open-minded to those who’ve been in this environment for years? And are you willing to take away the voice of the same healthcare “heroes” who sacrificed so much during the respiratory pandemic?
During COVID I think a lot of healthcare staff questioned whether or not to stay and serve their community while mentally suffering at the hand of it… we felt as though we had NO voice, NO rights, some lost jobs, family, children, parents and grandparents. Are you willing to create this space of restrictions for patients and healthcare professionals just to save a buck or two? Is that what really matters to you? Be the voice for patients and healthcare providers, don’t be another organization to strip that away. Taking that away, takes away the heart of those putting their health on the line every day to take care of strangers. I urge you to genuinely ask yourselves these questions and remember that your actions could tip the scales in justice and injustice. I encourage you to think about WHO all can be affected by the decisions YOU make… I appreciate you giving me a platform to express my thoughts on this matter. I hope you can hear us all out and come to the morally/ethically right decision to make and not just the financial aspect of it. Thank you and have a wonderful day.

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To Whom It May Concern,

I am writing to express my concerns regarding the CMS Proposed National Coverage Determination (NCD) for Noninvasive Positive Pressure Ventilation (NIPPV) in the home for the treatment of Chronic Respiratory Failure (CRF) due to Chronic Obstructive Pulmonary Disease (COPD).

While I commend CMS for acknowledging the importance of NIPPV in managing chronic hypercapnia and supporting patients post-discharge, I respectfully oppose several aspects of the proposed decision due to their potential to limit timely access to critical therapy, impose unrealistic operational barriers, and fail to fully account for the clinical complexity of managing CRF in COPD patients.

1. Restrictive Criteria Will Limit Access for Clinically Appropriate Patients
The proposed requirement of PaCO2 = 52 mmHg during awake hours on prescribed FiO2 risks excluding a large subset of patients with CRF who exhibit clinical benefit from NIPPV despite lower PaCO2 thresholds. There is robust clinical evidence that even patients with moderate hypercapnia benefit from early intervention with NIPPV, leading to fewer hospitalizations, improved quality of life, and reduced mortality. A rigid threshold may inadvertently delay treatment until patients worsen unnecessarily.

2. Overemphasis on “High-Intensity” NIPPV Settings May Not Be Universally Appropriate
The mandate to use a RAD with IPAP >20 cm H2O and a backup rate of =14 bpm overlooks the reality that such “high-intensity” settings are not tolerated by all patients. Moreover, the therapeutic effectiveness of NIPPV does not solely rely on these pressures but rather on patient compliance, symptom relief, and physiological response, which may vary significantly. This inflexible requirement may lead to patient discomfort, reduced adherence, and poorer outcomes.

3. Arbitrary Re-evaluation Timeframes and Usage Requirements Are Burdensome and Clinically Unnecessary
The proposed 180-day re-evaluation and ongoing usage criteria requiring =5 hours/day use and strict PaCO2 reductions may not be clinically meaningful for all patients. Many COPD patients experience gradual improvements or benefit from symptomatic relief (such as reduced dyspnea and improved sleep) without dramatic changes in blood gases. Requiring documentation of exact PaCO2 changes risks discontinuing effective therapy and places undue burden on both providers and patients.

4. Post-Discharge Coverage Limitations Ignore Clinical Realities
The restriction that post-discharge home use must mirror the device used in the final 24 inpatient hours lacks clinical flexibility. Patients often experience rapid respiratory shifts during recovery. Physicians should retain the ability to adjust the type or settings of NIPPV devices post-discharge based on the evolving needs of the patient, not be locked into a device based on an arbitrary administrative timeframe.

5. Local Coverage Should Be Preserved Where National Guidance is Too Narrow
Many clinical scenarios fall outside this proposed national policy—such as patients with overlapping obstructive sleep apnea and COPD (the “overlap syndrome”), or those who experience exacerbation-triggered CRF. Local Medicare Administrative Contractors (MACs) must retain flexibility to cover NIPPV in these situations under Section 1862(a)(1)(A), and CMS should explicitly affirm this discretion in the final NCD.

Conclusion
We urge CMS to reconsider elements of this proposed policy that, while well-intended, may create access barriers, delay therapy, and impose rigid requirements that are not aligned with the realities of treating COPD-related chronic respiratory failure. We recommend broader clinical inclusion criteria, more flexible usage thresholds, and allowance for physician-directed decisions post-discharge.

Thank you for the opportunity to comment. We hope CMS will revise the proposed NCD to better support clinicians and the patients we serve.

Sincerely,
Toni Cline RRT
Clinical Manager
Life DME

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The new mandatory re-evaluation will not only create a clinical burden but will also negatively impact our patients. Many of our patients already struggle to see their physician once a year, and now requiring biannual follow-ups will create significant access issues, particularly for patients in underserved and rural areas.

Additionally, the proposal to require an ABG test every six months to maintain therapy is both painful and unnecessary, especially when less invasive options, such as VBG and end-ETCO, are clinically more appropriate and more practical for home settings.

The proposed requirement of 5 hours of use per day is out of step with current clinical practice. A patient's benefit from therapy isn't always directly tied to a specific number of hours, and this metric risks disqualifying patients who are clinically improving with less use.

Please reconcider and/or re-evaluate the proposed guidelines.

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To whom it may concern,

I deeply appreciate CMS's efforts to improve access to noninvasive ventilation (NIV) patients, but I am troubled by aspects of the proposed rules that could negatively impact patients and providers:

Daily Use Requirement: Requiring patients to use NIV for at least 5 hours daily is overly rigid and disregards individual patient needs. This could unfairly deny care to those who benefit from shorter usage times.

Oxygen Threshold: Restricting NIV access to patients requiring more than 4 LPM of oxygen excludes many who could greatly benefit, particularly those with chronic conditions like COPD.

Frequent Follow-Ups: Mandating visits every six months, regardless of patient stability, adds unnecessary stress for patients and healthcare providers.

Administrative Burden: Increased provider responsibilities without additional compensation could compromise care quality and strain resources.

CO2 Testing Challenges: The requirement for unreimbursed, costly CO2 testing at home after discharge creates financial and logistical barriers for patients needing NIV.

Contradictory CO2 Standards: Requiring persistently high CO2 levels to justify ongoing NIV use conflicts with the treatment's goal of lowering CO2, which seems counterproductive.

I urge CMS to reconsider these rules, as they may inadvertently limit patient care and create undue burdens for providers. I hope CMS will collaborate with experts to craft guidelines that truly meet patient needs.

Thank you for your attention to these important concerns.
Katelyn Fincher

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As a respiratory therapist I have provided NIV therapy in more than one DME for the last 6 years. I also have lived with more than one family member with COPD. I have concerns with the new CMS proposed rules

For a proposed ABG every 6 months: They may have a more normalized result if they are compliant with their current therapy, are you going to disqualify someone for this? If they are in an exacerbation of the COPD that might be a different outcome, but our goal is to avoid this. An ABG is an invasive test that even in a hospital setting we tried to avoid performing repeatedly on a patient. The risks can include excessive bleeding, hematoma, infection. There are other less invasive ways to monitor the risks associated with an increased CO2 level.

The national average for the cost of an ABG is $279 a Medicare patient with no secondary may end up paying approx. $55 for testing, and another Pulmonary apt could mean another co-pay of possibly $20 Many of these patients miss appointments due to cost.

Getting to another appointment may be an issue for our homebound patients I have several who have a visiting physician service that writes the ongoing script for therapy once they leave the hospital, if a Pulmonologist is required every 6 months, they may require an ambulette for transportation these services are difficult to schedule, and expensive. The ABG would need to be a separate appointment and another trip out for patients, leaving home often causes such high anxiety they can't go, if you can’t breathe you are scared to leave home This begins the vicious cycle that can cause an exacerbation. I watched my spouse live through this he was afraid to leave home, he missed many appointments and refused to go to hospitals for treatment he recently died from complications of COPD. There are long waits currently for a new Pulmonologist appointment, this will cause a delay for patients who may have more critical needs. Trusting the partnership between the respiratory therapist and the treating physician taking care of these fragile patients should have some relevancy in these decisions.

I would ask these proposed guidelines would be evaluated with the concerns of the delicate lives of those needing the therapies we provide, and the separate need for appointments and services that go along with it. Please allow the prescribers and the companies providing equipment and services the time to smoothly implement the new guidelines so no one does without lifesaving therapy.

Thank you

Sandy

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Statement in Support of Coverage for Non-Invasive Ventilation at Home (NIVH) – HCPCS Code E0466 – and Concerns Regarding Proposed NCD Changes

As a Registered Respiratory Therapist working in the home care setting, I respectfully urge the Centers for Medicare & Medicaid Services (CMS) to maintain—and ideally expand—access to Non-Invasive Ventilation at Home (NIVH) under HCPCS code E0466 for Medicare Fee-for-Service (FFS) beneficiaries. Additionally, I strongly encourage CMS to reconsider certain aspects of the proposed National Coverage Determination (NCD) changes, which could inadvertently jeopardize patient outcomes and increase overall healthcare costs.

The study "Impact of Non-Invasive Ventilation at Home (NIVH) on Select Outcomes for Medicare Fee-for-Service Beneficiaries" provides compelling evidence that NIVH significantly reduces hospitalizations, emergency department visits, and mortality among patients with chronic respiratory failure. NIVH not only improves quality of life but also results in measurable cost savings for Medicare.

However, several aspects of the proposed changes to the NCD raise significant concerns:

After reading through the proposed changes being made to NIPVV coverage I feel compelled to reach out and voice my concerns.

I fore see many patients struggling with the proposal of requiring patients to be seen every six months for re-evaluation of therapy. I care for patients that live in multiple communities throughout Illinois, however a large portion of the patients I see live in either Champaign County or Vermilion County. Both counties have many people that are living in poverty. Champaign County has 19% of its population that live in poverty and Vermilion County has 17% of its population that live in poverty (Illinois State Poverty Percentage Map | Illinois State Census Data Center | Illinois Extension | UIUC). Not only is there a large percentage of poverty, but there are many rural areas where patients do not have access to public transportation and accessing medical care is challenging in itself. It can be difficult for patients to do this annually but by adding a second required visit each year this creates more roadblocks for the patients to get adequate care that they deserve.

Adding the second required visit with a provider each year will not only put a financial and transportation strain on patients that require NIPVV but will negatively affect all patients that need to see a Pulmonologist. Prior to this proposed change, the average wait time to see a medical provider across the country is 27-70 days ( In the U.S., wait times to see a doctor can be agonizingly long | Association of Health Care Journalists). Adding the additional required appointments will add more burden to our healthcare system and make accessing medical care for everyone more difficult.

The proposed requirement of ABG’s must be obtained every 6 months is also very concerning. ABG’s are not a painless procedure. Arteries are surrounded by nerves, and it can be a very uncomfortable procedure for the patient. It is not uncommon for arteries to spasm due to the patient’s anxiety of having this sample obtained, which makes the patients’ blood sample more difficult to obtain. It is an invasive procedure that puts the patient at unnecessary risk of permanent nerve damage and infection. ABG’s must be processed in a timely fashion (within 10 minutes with the sample being rotated to prevent clots forming) or the results will not be accurate. In rural settings this may be a challenge that patients face, as not all facilities are able to obtain or process these samples. This would again require patients to travel to facilities that are able to properly collect these samples and process them quickly. Again, many of these patients are living in a rural setting and many do not have easy access to transportation.

I am very concerned about the proposed change requiring patients to have a CO2 level of 52 mmHg to qualify for NIPVV. The American Thoracic Society’s clinical practice guidelines include a recommendation of treatment at 45 mmHg. By CMS increasing the CO2 level requirements many patients with chronic lung disease will be left without treatment. As a result, the patient’s disease will continue to progress, and their quality of life will decrease.

I find it very concerning that the proposal is forcing the use of high-intensity modes. Not all patients are the same and the settings should be determined by a provider that is treating the patient. Mandating settings is dangerous and could result in harming patients. Causing additional damage to their lungs. Pulmonologists are specially trained in managing this delicate population and settings should only be prescribed by them.

Patients that have been on NIPVV for years should also be grandfathered in and not be required to completely change their requirements for continued use of their therapy. The proposed changes could result in them losing access to a therapy they are dependent upon and drastically shorten their life.

I foresee many of the concerns I have addressed resulting in more frequent hospitalizations due to COPD exacerbations, resulting in more cost for the healthcare system but also the patients. I foresee patient’s lives being shortened by these proposed changes and my sincerest hope is that you will reconsider the proposed changes.

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CMS PROPOSED CHANGES FOR NIV AND RAD PATIENTS

I have been in the RT field for almost 30 years and have been in contact with many respiratory patients. Dealing with COPD patients and their abilities to maintain a healthy and somewhat normal life. We become their advocates to keep them from being re-admitted to the hospital several times throughout the year, which will increase the cost of health care and all the expenses that go with it.

6-month re-evaluation: Most of my NIV patients that I now see do have follow ups scheduled with their MD every 6 months. I do see a problem though for some who are not able to get out of their home environment on a regular basis. These patients utilize the option to video chat with their physician, which makes the ability to be in contact with their physician much easier for them. This helps in the long run to be able to make sure the patient is compliant with all of the treatments that they are currently on.

Repeat ABG’s every 6 months: This portion of the proposal I would see being a deterrent for the patient. Most of the patients do not like having this procedure done. It is an invasive procedure that really is not necessary on a routine basis to obtain the data that would be needed to make sure the patient is getting good benefit from the treatment(s) they are on. This procedure would require most of the patients to be required to have a prescription from their physician, have an appointment, arrange transportation, which could be mostly an out-of-pocket cost to the patient themselves. This procedure is not able to be done at the local “LAB”, it is required to be done by a Respiratory Therapist. This would also mean that you would have to have a Respiratory Therapist dedicated to being available for “outpatient procedures” at the hospital. Once again, this is going to drive the cost of health care up.

Increase average usage to 5 hours per day: This proposal could also be a deterrent for the patients. It is also an educational issue. If we educate our patients and families on the benefits of the NIV unit this might not be such a shock for the patient. Some patients struggle with using the NIV, because they feel they are tied down. If we keep harping on the patients that they “need” to do stuff, they tend to do the opposite. Again, it is all in the education.

High-Intensity Modes: The mode the patient is prescribed should be left up to the physician and the respiratory therapist. This should not be delegated by insurance. We were educated for many years to be able to treat and help the patients with their disease process. We have a better understanding of how the process works and functions.

Grandfathered patient’s: If patients are not going to be grandfathered in, I foresee this proposal being very detrimental to the patient. I have seen this first hand. I had a patient who had been on the NIV unit for over 2 years, it had kept him from being admitted to the hospital for over them 2 years. He recently was reevaluated by insurance to approve his NIV and was denied. We had the physician do an appeal, even sent the documentation that he was tried on a RAD and failed, had a repeat ABG done, and based on the criteria he no longer qualified for either. So the NIV had helped him for over 2 years, his COPD disease process was kept at a level he was able to maintain a somewhat normal lifestyle. Now that we took the NIV, he is going to end up back in the hospital with multiple visits.

I currently am involved with my patients regularly. They feel very comfortable with the goals we set. These patients do not handle stress well, they get very anxious when criteria is changed.

There needs to be more “free” educational opportunities for these patients.

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To CMS,

Regarding the proposed changes to the NIPPV Coverage Criteria, Testing, Re-evaluations, and Device Selections. I have the following comments as to why this policy should seriously be reconsidered.

1. The Policy does not specify whether or not certain beneficiaries that are currently receiving the NIV therapies prior to the effective date will be grandfathered in. They must be. The impact to thousands of COPD patients lives will be at risk as they are unable to be tested, see their MD's, undergo ABG in-hospital testings, may not qualify and subject to collections, they would be responsible for their ventilators, equipment will be pulled from their homes, their oxygen tied in to their ventilation would be compromised.

2. The request to perform repeated Arterial Blood Gas (ABG) every 6 months as part of re-evaluation is unnecessary and very invasive for our COPD patients especially for our rural patients lacking hospitals or other specialty faciltieis. ABG's can rarely be done in the doctors offices or Labs.

3. Finally, the proposed requirement for a patient to utilize therapy for 5 hours a day on average is not consistent with industry standards. For example, PAP therapy is greater than and equal to 4 hours per night on 70% of the nights and for a 30 day period. This also has a potential to disrupt patient care, especially considering that much of this equipment does not have modems from many of the manufacturers available.

Thank you for your serious consideration to modify this criteria and to NOT create patient harm.

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I strongly support CMS efforts to update coverage for home non-invasive ventilation (NIV) or home mechanical ventilation (HMV) in COPD-related chronic respiratory failure, recognizing significant patient benefits demonstrated in recent clinical studies. However, I have few concerns and recommendations:

• Concerns Regarding Fixed PaCO2 Thresholds:
  • Fixed PaCO2 thresholds do not reflect clinical variability. PaCO2 levels fluctuate based on disease state, diurnal variation, and recent interventions (1).
  • The HOT-HMV trial (Murphy et al., 2017) demonstrated that home NIV reduced hospital readmissions and mortality in COPD patients with persistent hypercapnia, but emphasized clinical assessment over strict thresholds (2).
  • International guidelines, including the ERS/ATS clinical practice guidelines (2019), recommend initiating home NIV in stable hypercapnic COPD patients post-exacerbation, without enforcing a rigid PaCO2 cutoff to accommodate individual variability (3).
  • Strict PaCO2 requirements risk excluding patients who would benefit from early or preventative intervention.
  • Requiring rigid PaCO2 thresholds delays access for symptomatic patients, prolonging suffering, increasing risk of readmission, and missing opportunities for proactive care.
• Recommendation to broaden acceptable CO2 measurements: CMS should consider accepting alternative validated measures of CO2, including venous blood gas (VBG) or transcutaneous CO2 monitoring (TcCO2), which are less invasive, more accessible in outpatient settings, and correlate well with PaCO2 trends in stable chronic respiratory failure (4,5).
  • These methods reduce patient burden and increase diagnostic access, particularly in rural and under-resourced settings where ABG may not be readily available.
  • For frail, elderly, or homebound patients, frequent ABGs increase procedural burden, discomfort, and healthcare costs.
• Concerns Regarding Continued Coverage Requirements:
  • Requiring repeat arterial blood gases (ABGs) to demonstrate ongoing hypercapnia risks penalizing effective therapy, as successful NIV often lowers PaCO2 (6).
  • Repeated ABGs are invasive, burdensome, and provide limited value after initial stabilization.
  • Patients stabilized by therapy should not undergo unnecessary repeat invasive testing, which may cause anxiety, pain, and additional logistical hurdles.
  • The CHEST consensus statement (2023) recommends using clinical outcomes such as reduced healthcare utilization, improved symptoms, patient-reported outcomes, and therapy adherence to guide continuation of home NIV (7).
• Concerns Regarding Proposed Average Use Requirement (=5 hours per 24-hour period):
  • While adherence to therapy is important, a rigid requirement of =5 hours average daily use does not account for individual patient variability and clinical benefit below this threshold.
  • Lack of clarity in the proposed rule: It is unclear over what timeframe the “average use” is measured (e.g., weekly, monthly) or how periods of illness, hospitalization, or initial acclimatization are handled.
  • Patients often require a gradual acclimatization period, and rigid adherence criteria early in therapy could lead to premature discontinuation despite potential long-term benefits.
  • Studies such as Struik et al. (2014) show that even lower levels of adherence (e.g., 3–4 hours per night) can yield improvements in gas exchange and reduce exacerbations in select patient populations (8).
  • Overly strict hour-based adherence requirements risk penalizing patients who benefit from nocturnal use alone or those with progressive tolerance issues (e.g., mask discomfort, comorbidities limiting duration of use).
  • CMS should consider a more flexible, outcomes-focused approach that emphasizes demonstrated clinical benefit and patient-reported outcomes over fixed hourly use metrics.
• Recommendations for CMS Policy Improvement:
  • Allow flexibility in PaCO2 criteria to reflect clinical variability and patient-specific factors.
  • Expand acceptable methods of CO2 measurement to include venous blood gas (VBG) and transcutaneous CO2 monitoring, which are less invasive, widely available, and correlate well with ABG in chronic respiratory failure management.
  • Use outcomes-based measures for continued coverage, including:
    • Therapy adherence (without rigid or unclear hourly thresholds).
    • Reduced hospitalizations or exacerbations.
    • Improvements in quality of life or respiratory symptoms.
    • Physician clinical assessment confirming ongoing benefit.
  • Clarify and reconsider the usage measurement period to avoid penalizing patients during adjustment periods or episodes of acute illness.
  • Align CMS policy with established, evidence-based international guidelines for the management of chronic respiratory failure in COPD.

Revising the PaCO2 criteria, accepted testing methods, usage time requirements, and continued coverage criteria will promote patient access to life-sustaining ventilatory support, reduce hospital readmissions, and align CMS policy with contemporary clinical evidence and expert guidance.

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The new requirements qualifying a patient for NIV are overdue. This is a highly abused area made possible by a lack of guidelines by CMS. I am in favor of most of these. Just decide on the new guidelines and announce an effective date. The only 3 areas of concern:
1) As I understand the proposal, existing patients will be subjected to all these new guidelines to continue coverage. I believe there should be a 6-month grace period for existing patients to allow them time to be requalified under the new requirements. I agree with requiring continued coverage and documentation of compliance.
2) The mandatory minimum RAD settings seem to be a bit aggressive and incomplete. There is no guidance regarding tidal volume. Tidal volume X rate is what equates to ventilation on the machine. If you are going to mandate a minimum IPAP and back up rate setting, I believe a tidal volume setting is necessary, as well. Without it, the machine will not provide the proper ventilation. If you are not providing tidal volume minimums, you should not provide the other settings. The minimum back up rate of 14 seems to be a bit aggressive when compared to typical settings A back up rate of 8 seems more in line with what we normally see from physicians.
3) There is no provision for patients with diagnosed sleep related hypercapnia. You only deal with COPD patients. The policy as written, restricts the ability of the physician to treat these patients using the same equipment as hypercapnic patients who happen to be awake.

I understand these new rules are aimed to make it more difficult to prescribe NIV. You may phrase it differently, but that is the net effect. Again, I understand. This has been highly abused.

One more offering I have...if you want to reduce the prescribing and usage of this therapy by people who are not serious about improving their health, mandate that a patient cannot continue NIV if they continue to smoke or vape. A patient diagnosed with COPD and CRF that continues to smoke or vape is not cooperating with the physician, thus should not qualify as a compliant patient. Medicare can save untold millions of dollars with this one policy revision.

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To Whom It May Concern,

I am writing to express my appreciation for the Centers for Medicare and Medicaid Services’ (CMS) efforts to improve coverage criteria for noninvasive positive pressure ventilation (NIPPV) in the home setting. With 30 years of experience as a Respiratory Therapist, the majority of which has been focused on durable medical equipment (DME) and homecare, I feel it is imperative that coverage criteria for COPD patients with chronic respiratory failure be clearly defined for DME providers and insurers across all Medicare variations, including all Medicare Advantage plans. However, l believe it is essential to address several key concerns regarding the proposed rules. These concerns, if unaddressed, could significantly impact patient access to care, clinical outcomes, and the sustainability of provider practices.

Criteria for Hypercapnia:

The requirement for an arterial blood gas (ABG) with a PaCO2 >52 to confirm hypercapnia is overly restrictive and arbitrary. A PaCO2 >45 mmHg should be considered conclusive evidence of hypercapnia, aligning with established guidelines from the National Institutes of Health (NIH). This threshold more accurately reflects ventilatory deficit or respiratory insufficiency and would ensure a more appropriate and timely intervention for patients in need of NIPPV.

Oxygen Requirement:

The stipulation that patients must be on continuous oxygen at >4 liters per minute (LPM) while using NIPPV is similarly restrictive. Oxygen therapy is appropriate for patients experiencing hypoxemia, but this requirement does not account for the fact that some patients may be hypoxic without being hypercapnic. For example, many patients with severe COPD may require only 2-3 LPM of oxygen to resolve hypoxemia but may still present with hypercapnia and thus require ventilatory support. A more flexible and clinically reasonable oxygen requirement would ensure that these patients have access to appropriate treatment.

Six-Month Follow-Up:

The proposed requirement for re-evaluation by day 180, and every six months thereafter, as a condition for continued coverage of a RAD/HMV, is redundant and burdensome. Chronic respiratory conditions, such as Chronic Respiratory Failure and COPD, require long-term management, and patients who have demonstrated initial clinical benefit should not be subject to arbitrary timelines for continued coverage. Instead, continued coverage should be based on clinical need, as determined by the treating physician’s attestation. Furthermore, the criteria for improved clinical outcomes, such as the normalization of PaCO2 or a 20% reduction in PaCO2 from baseline, necessitate the use of ABG testing. This imposes an additional burden on patients, particularly in rural areas where ABG testing may not be readily available. Given that RAD/HMV devices are capped rental items for COPD patients, these additional requirements could potentially undermine access to essential care.

Daily Use Requirement:

The proposed requirement of 5 hours of daily use as a benchmark for compliance and continued coverage lacks strong clinical justification. Under the current guidelines, CMS requires 4 hours of daily use for 70% of the time within the initial 90-day coverage period for E0601. The introduction of a 5-hour daily use requirement seems to be driven by reimbursement considerations, rather than clinical evidence supporting improved outcomes. Patients’ needs for NIPPV vary, and rigid criteria regarding daily use may exclude individuals who experience positive outcomes with shorter but still effective patterns of use.

IPAP Requirement:

Imposing the criteria of inspiratory pressures greater than or equal to 31cm H20 for coverage of a HMV does not seem to be supported by clinical evidence. It seems to be applied in this case as solely a criterion and a barrier to patients receiving an appropriately therapeutic device as those are currently reimbursed at a higher rate. COPD patients require volume and higher flows rather than high inspiratory pressures to assist their ventilatory needs.

Patients Currently treated with HMV:

I respectfully request that strong consideration be given to COPD patients currently receiving therapy and benefiting from the use a HME. It is not immediately clear from the proposed criteria how these existing patients would be impacted. Additionally, I have concerns about any potential liability should these patients be harmed if not provided the opportunity to continue with their current therapy.

In conclusion, while I commend CMS for its ongoing efforts to improve patient care, I urge you to strongly consider delaying this decision. I encourage further revisions to these proposed rules to ensure they reflect a more balanced, patient-centered approach. I hope that my concerns are considered thoughtfully in the final decision-making process to better serve both patients and providers.

Thank you for your time and consideration.

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Accept please find a comment letter from Cleveland Clinic.

March 19, 2025

Centers for Medicare and 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

Submitted via: CMS.gov

Cleveland Clinic is a not-for-profit, integrated healthcare system dedicated to patient-centered care, teaching, and research. With a footprint in Northeast Ohio, Florida, and Nevada, Cleveland Clinic Health System operates 23 hospitals, including a main campus near downtown Cleveland, with more than 6,690 beds, and 276 outpatient locations. Cleveland Clinic employs over 5,700 physicians and researchers, and 16,500 nurses. Last year, our system cared for 3.3 million patients, including 13.7 million outpatient visits and 323,000 hospital admissions and observations.

We reviewed the proposed decision memo by CMS and the decisions to eliminate the nocturnal desaturation criterion for device eligibility and the need to demonstrate failure of respiratory assist devices (RAD) without backup rate. We found the document to be well crafted and in line with the TEP recommendations. Nonetheless, there are several areas that may pose challenges for beneficiaries and physicians detailed below.

Contemporary randomized controlled trials using high intensity non-invasive ventilation (NIV) and one year follow-up, have all selected backup rates of at least 14 [1-3]. Nevertheless, we would recommend removal of the requirement for that specific cut-off in the initial coverage period. Specifically, there is a risk of asynchronies with the use of an excess backup rate, most notably the development of ineffective triggering which may defeat the intent of effective ventilation. In a study cataloguing the types of asynchronies with NIV, objectively assessed with a parasternal electromyography(EMG), 6-25% of the nocturnal breaths in patients with chronic obstructive pulmonary disease (COPD) were ineffective [4]. Importantly, ineffective triggering was associated with the aggressive settings planned for COPD, including higher respiratory rate and levels of inspiratory support, and may defeat the purpose of providing effective ventilation [5]. The requirement for a minimal backup rate of 14 may frustrate effective support, and limit options for clinicians who recognize asynchronies on clinical or polysomnographic evaluations. As currently written in the proposed memo, the fallback option for such patients would be to use no backup rate at all, which is distinctly suboptimal. The goal is reduction of the partial pressure of carbon dioxide in arterial blood (PaCO2) with NIV rather than the use of arbitrary settings.

To that end, proposing a specific threshold of inspiratory positive airway pressure IPAP >20 cm H2O imposes an unnecessary restriction. As alluded to, high intensity ventilation is a mechanical ventilation strategy that aims to reduce blood carbon dioxide tension. The goal of carbon dioxide reduction can be achieved by different combinations of tidal volume (achieved via pressure or volume control) and respiratory rate. As long as the goal is reached, the ventilator mode with which this is attained should be immaterial [6]. In a meta-analysis of individual patient data from seven randomized control trials, Struik and colleagues concluded that an IPAP level l=18 cm H2O is required for achieving high intensity ventilation [7]. More recently, Jiang and colleagues were able to achieve carbon dioxide reduction to within normal levels or by at least 10 mmHg with an average IPAP of 16 cm H2O [8]. Our experience is also aligned with these reports that an average IPAP of 18 cm H2O is sufficient in reducing PaCO2 by 20% [9]. We believe that a suggestion of settings, e.g. IPAP =18 cm H2O, RR> 13/min) rather than an imposition would be more helpful.

We also note that CMS proposes to cover home mechanical ventilation (HMV) used in a volume targeted mode particularly upon hospital discharge. "Volume targeted mode" is an ambiguous term and may mean volume-controlled modes or pressure-controlled modes with adaptive targeting scheme (e.g. average volume-assured pressure support (AVAPS) or pressure-regulated volume control, (PRVC)). We recommend using standard terminology when referring to modes [10]. Importantly, there are no data in the literature that indicate superiority of volume versus pressure control or targeting in achieving high-intensity ventilation. In fact, modes that have been used in the three- seminal trials [1-3] were all pressure controlled. We recommend removing the ambiguous term “volume targeted mode” and discourage use of specific modes. A recommendation to use pressure-controlled intermittent mandatory ventilation may better reflect the current state of knowledge.

The increase in adherence requirement from a usual four hours to five hours may severely curtail the ability of patients to adapt to the device. Higher pressures may improve adherence compared to lower pressures [11], but adherence can still be low with one study showing only five of nine patients using the device for at least four hours per night post despite efforts at improving adherence [12]. A cutoff of at least five hours results in better improvement in PaCO2 [13]. However, a large study of patients with hypercapnic respiratory failure (19% of which had obstructive lung disease) managed with NIV, and followed over six years, adherence for more than four hours per day was associated with a lower mortality (HR 0.64, 95% CI 0.51 to 0.79) [14]. Raising the requirement to five hours may result in the removal of a device with potential survival benefits.

Finally, there are compelling arguments to provide a pathway to provide NIV on discharge following a hospitalization for COPD exacerbation [15]. Data from the home oxygen therapy, home mechanical ventilation (HOT HMV) trial suggest that out of 2021 admitted with a COPD exacerbation and decompensated respiratory failure, 419 (21%) had no hypercapnia (PaCO2 <53 mm Hg) and/or no hypoxemia (PaO2 > 60 mm Hg) 2-4 weeks after resolution of the decompensated state [2]. Therefore, a substantial proportion would remain hypercapnic > 53 mmHg in a follow up stable state. This may be especially true for those with a hospital PaCO2 > 60 mmHg which may encompass over 40% of patients, of which 88% may still qualify for NIV on follow up [16]. We would advocate for maintaining the recommendations of the Technical Expert Panel to leave that decision to the physician’s discretion [17].

Thank you for conducting a thoughtful process that allows us to provide input on such important issues and for your consideration of this information. Should you need any further information, please contact us at aboussl@ccf.org and hatipou@ccf.org.

Sincerely,

Dr. Loutfi S. Aboussouan
Director, Restrictive Thoracic Disorders Program
Integrated Hospital Care Institute, Cleveland Clinic

Dr. Umur Hatipoglu
Enterprise Medical Director of Respiratory Therapy, Cleveland Clinic
Director, COPD Program
Professor of Medicine, Cleveland Clinic Lerner College of Medicine,
Case Western Reserve University School of Medicine
Integrated Hospital Care Institute- Cleveland Clinic

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Hello,

I am writing in regard to the recent CMS changes. These updates will significantly impact our current COPD population, as ongoing ABG testing can be both painful and burdensome particularly for chronically ill patients who have limited mobility and are unable to leave their homes frequently.

Additionally, the proposed six-month re-evaluation requirement presents a challenge. As someone working in DME, I witness firsthand the difficulties these patients face in securing even an annual follow-up with their physicians.

Timely access to noninvasive ventilation is critical to ensuring these individuals receive the life-sustaining care they need.

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The proposed changes for the NCD covering NIV/RAD for COPD will present a large burden for patients with a disease that causes crippling changes to quality of life.

Requiring a patient to undergo a every six-month follow-up visit and repeat ABG will challenge patients due to several issues:
1- Lack of transport for appointments especially those living more than 30 miles from their physician.
2- Increased costs including: fuel, lab fees, physician visits on top of already high rental copays.
3- Difficulties/delays in arranging care; many specialized physicians have limited appointment availability and ABG testing often requires a hospital visit.
4- Exposure to infection. Visiting locations where other patients may have acute illnesses increases the risk of community acquired infection.
5- ABGs are a very invasive test with many possible negative effects. Other testing, specifically VBGs/EtCO2 monitoring, are adequate to monitor for changing disease states (pH and bicarbonate values).

I also encourage a grandfathering provision allowing patient currently using therapy to avoid the time and expense of news testing/visits.

Please considering delaying any new rule until concerns have been adequately examined and resolved.

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I have a number of concerns regarding this proposal. I list list for easy review
- 90 ABG testing is painful for patients and difficult to arrange. Doctors have backlogs for appointments and creates an undue on the patient to travel in rural areas for testing. There are easier noninvasive solutions like capnography to achieve the same results.
- 5 hours of daily use is high and seems arbitrary. Pap therapy only requires 4 hours and many patient benefit from much less to help control CO2 levels.
- High pressure setting requirements are also seem arbitrary. While many patients benefit from high pressure this is not required for all patient to see the benefits of therapy
- 6 Month re-evaluations also create a burden on the system. Patients struggle for appointment access as it is. This will only serve to exacerbate that issue.
- No grandfathering. There are thousands of stable patients benefitting from the therapy that may not qualify under these guidelines. Their testing values are improved as a result of the ongoing therapy and achieving the very goals set out by the therapy.
- CMS's own data clearly shows that with early initiation of non invasive ventilation therapy there is reduced hospitalization. It increases life expectancy and lowers overall expenditures

Please reconsider these proposals. They are short sighted and will end up costing the system more in the long run.

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If this new rules is adopted, thousands of patients will be forced into the Critical Care / Hospital system who are currently cared for in the homecare setting. This will cost Medicare and other payors BIG. This is especially true in rural areas such as Alaska where access to specialists, testing, and follow up is challenging particularly for patients who are fragile such as these.

Adherence to at least 5 hours a night creates yet another level of regulatory control and cost to a system that is already heavily regulated and burdened with regulations and requirements. Additionally, 5 hours appears to be a random requirement which is not based on any kind of clinical criteria but rather another bureaucratic hurdle.

Requirements to repeat blood gas every 6 months is ridiculous. These are Chronic patients who's BASELINE condition is not expected to improve. The goal for patients like this is to prevent frequent re hospitalizations for the remainder of their lives and hopefully provide some quality of life. Additionally, access to specialists and facilities to achieve these tests is near impossible in rural settings such as Alaska.

Requirements to re evaluate every six months carries the same concerns as repeat blood gas every 6 months.

There is no pathway for grandfathering in existing patients which is very concerning.

If adopted as is, this proposed NCD will overwhelm the critical care system/long term care system and place thousands of patients at risk. This is wreckless and insane.

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I submitted a comment before and forgot the most essential part that needs to be addressed. Treating Hypercapnic Respiratory Failure and COPD with nighttime Respiratory Assist Devices will not cover the entire 24-hour period of the patient's medical necessity to treat their symptoms. We need to address the issue of daytime therapy and CO2 retention. Two-thirds of the 24-hour therapy period would be predominantly ignored. This should be added to the CMS HMV criteria that these patients can have the daytime therapy mode, which I address in this comment.

It is critically vital that CMS does not require an oxygen liter flow of 4 LPM or more as a criterion to qualify for home mechanical ventilation (HMV). Most medical professionals aim to reduce CO2 retention and oxygen dependency through proper HMV ventilation therapy. If done right, with a great care plan, these patients can reduce the need for higher flow oxygen. We are not treating a sleep disorder like most CMS RAD LCDs point out. Please read on:

Patients with hypercapnic respiratory failure and COPD, who meet all diagnostic qualifications, are prescribed ventilator support because the goal is to reduce both CO2 levels and oxygen flow requirements.

One major issue CMS has yet to address is the daytime medical need for Mouthpiece Ventilation (MPV). What is MPV? It’s a form of therapy designed to help patients quickly reduce the daytime CO2 retention during episodes of respiratory stress through a mouthpiece and prescribed high flows of air to fill up the lungs and recruit parts of the lungs that have not been accessed for a long time. CMS continues to confuse this as just a nighttime therapy need. It is a 24-hour medical necessity to keep these patients out of expensive hospital ICU or main floor stays. With MPV, the ventilator can remain on all day, silent and inactive, ready to be used only when needed. Instead of calling 911 during a panic episode, vasoconstriction occurs, and patients can self-administer ventilation to ease their symptoms, often avoiding dangerous oxygen increases that can worsen outcomes in COPD. Turning up the oxygen flow during a CO2 crisis is like pouring gas on a fire. This is because the patient cannot ventilate fast enough. It is part of the diagnosis name, Chronic OBSTRUCTIVE Pulmonary Disease. When we breathe in room air, the oxygen is sent to all areas of the body to provide the necessary oxygen and picks up the CO2 to allow us to breathe this out through the lungs and, in chronic cases, even through the urine or sweat.

I am the CEO and have been a respiratory care practitioner for over 30 years, and I’ve seen the power of a well-structured Plan of Care for managing COPD with HMV. Unfortunately, a major gap in our industry is that patients are often placed on HMV or NIV with no plan of care in place, leaving them vulnerable to repeat hospitalizations due to unmanaged respiratory medications prescribed by most physicians.

Let me share a true success story. I was introduced to a patient nicknamed “Skip” in August. He had already been hospitalized six times since January and was on 8 LPM of oxygen. When I asked why he kept returning, he said, “I feel like I can’t breathe, so I call 911.”

I told Skip what a well-known Utah pulmonologist once told me—somewhat bluntly—that “the stupidest patients to exist are COPD patients.” I was shocked, but he explained: “They’re not getting enough oxygen to the brain because they won’t follow the Plan of Care.”

So I laid one out for Skip:

1. Use MPV for 5–20 minutes before each nebulizer treatment.
2. Administer the nebulizer treatment.
3. Wait 20 minutes.
4. Use MPV again for another 5–20 minutes.

5. Skip promised to follow the plan. Just two and a half weeks later, he called with excitement:
   “I have great news! My physician dropped my oxygen from 8 to 2 liters per minute!”
   This is just one of many success stories I’ve seen. With proper daytime MPV use and consistent home ventilation at night, patients can reduce oxygen dependence and avoid unnecessary hospital visits.
   CMS must recognize the importance of MPV and comprehensive respiratory care plans to support patients with chronic respiratory failure.

   Please remove the requirement for oxygen flow greater than 4LPM. I get my patients to more manageable oxygen flow rates within the first 30 days. Taking away a home mechanical ventilator would only be a massive setback for my patients.

   Remember, this therapy is to help patients stay out of hospitals and remain at home, where they can manage their diagnosis more affordably. An HMV will cost way less than 1 or more hospital stays for a whole year.

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On behalf of the California Association of Medical Product Suppliers (CAMPS), we appreciate the opportunity to comment on the CMS Proposed Decision Memo (CAG-00052R2) regarding revised national coverage criteria for Noninvasive Positive Pressure Ventilation (NIPPV) devices.

CAMPS is a statewide association representing home medical equipment (HME) providers and respiratory care suppliers that serve thousands of patients across California, including vulnerable populations with chronic respiratory conditions such as COPD. We are deeply concerned that the proposed coverage revisions, as written, would significantly reduce patient access to medically necessary respiratory care, create undue administrative burden for providers, and introduce clinical requirements that are not aligned with current practice guidelines or patient realities.

Key Concerns:
1. Six-Month Re-Evaluation and Repeat ABG Requirement
The proposed requirement for a six-month re-evaluation and repeat Arterial Blood Gas (ABG) is both clinically unnecessary and logistically burdensome. For many patients—particularly those in rural or underserved areas—frequent re-testing is not feasible and would likely result in disruption of therapy or even discontinuation of care.
2. Five-Hour Daily Usage Requirement
The proposed five-hour minimum daily use threshold does not reflect the individualized nature of therapy for chronic respiratory failure. Many patients benefit from use at night only, and applying a blanket requirement may result in unjustified denials of ongoing coverage.
3. Lack of Grandfathering for Existing Patients
There is no clear provision for grandfathering patients who are currently receiving NIPPV under existing criteria. This raises serious concerns about continuity of care and could result in abrupt and harmful discontinuation of therapy for patients who are stable and clinically benefiting from current treatment.
4. Implementation and Operational Challenges
The proposed changes present significant challenges in documentation, clinical coordination, and billing—especially for small and mid-sized suppliers. Without clear implementation timelines and support, the burden of compliance could drive providers out of this vital service area, further limiting patient access.

CAMPS urges CMS to:

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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