As it reads currently, the Centers for Medicare & Medicaid Services’ national coverage analysis (NCA) for noninvasive positive pressure ventilation (NIPPV) “will create unnecessary barriers to essential care,” the American Association for Homecare said in comments submitted April 10.
AAHomecare released its official comments on April 16. The public comments period closed on April 10, though comments are still viewable.
Request for changes, delayed implementation
AAHomecare asked CMS to “make substantive changes to the proposed NIPPV NCA and delay implementation until those changes can be made.” The problems, the association said, stem from “overly prescriptive criteria that will interfere with the physician’s ability to exercise their medical judgment and ensuring requirements for durable medical equipment (DME) suppliers that are virtually impossible to comply with.”
The association asked CMS to make the national coverage determination (NCD) “consistent with medical practice” and “both practical and implementable.” AAHomecare also asked CMS to postpone implementation and the effective date “for a year from the publication of the final NCD to ensure appropriate continued access to NIPPV therapy.”
“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 said in its comments.
AAHomecare lists its concerns
AAHomecare objected to the following, as proposed in the NCA:
— Patient re-evaluation every six months to remain qualified for NIPPV. AAHomecare said that requiring such frequent re-evaluations “will make it even harder for chronically ill patients, especially those in rural areas, to access essential ventilation therapy.”
— Requiring an arterial blood gas (ABG) test as part of the six-month re-evaluation. AAHomecare called ABG testing “painful and invasive,” as well as unnecessary because “other reliable and less invasive tests approved by the prescribing physician that can confirm hypercapnia” do exist.
— Requiring the patient to use NIPPV for an average of five hours daily. That five-hour period “is more restrictive than any other Medicare policy regarding device usage and 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,” AAHomecare said. The association added that current NIPPV devices “are not equipped to track or report this metric without the addition of expensive modems,” making it more difficult for patients to comply.
AAHomecare asked this compliance requirement to align with current CPAP and RADs [respiratory assist devices] requirements — at least four hours per day for 70% of days in any 30-day period — or to allow the beneficiary’s physician to document the patient’s ongoing medical need.
— Requirement for “RADs without backup rate feature” is “inconsistent with the FDA [U.S. Food and Drug Administration]-approved indications for use for these devices.” AAHomecare noted that RADs are currently approved by the FDA only for obstructive sleep apnea: “They are not approved for use for respiratory insufficiency.”
— The absence of the ability to grandfather patients receiving NIPPV before the effective NCD date. AAHomecare recommended that these patients retain access “to prevent disruptions to their life-saving/life-sustaining therapy.”
Study using Medicare data shows NIV benefits
In its comments, AAHomecare referenced the 2025 Dobson DaVanzo study that examined how noninvasive ventilator (NIV) use at home impacted Medicare patients.
Summarizing the study, the association said patients who received NIV treatment “had better outcomes than beneficiaries without NIV treatment,” and added that the sooner a patient began using NIV, the lower the risk of death. Patients who quickly started NIV use were also less likely to be hospitalized or need to make hospital emergency department visits. These patients also cost Medicare less overall.
“We encourage CMS to leverage its own claims data to inform policy decisions regarding the NCD,” AAHomecare said in its comments.
AAHomecare added “it will be important” for CMS to inform Medicare Advantage (MA) plans of the final NCA “and exercise oversight to ensure that MA plans provide coverage for these medical devices consistently with the national coverage criteria. Our members’ experiences confirm that MA plans often fail to follow Medicare FFS [fee-for-service] coverage for NIPPV services, resulting in significant delays in patient care and, in some cases, denials of therapy.”
Repeatedly in its comments, AAHomecare advocated for allowing physicians to decide the best course of treatment for their patients.
For example, when a hospital patient is discharged home, “CMS proposed 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 [chronic respiratory failure] due to COPD [chronic obstructive pulmonary disease] 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 proposed NCA said. “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.”
“AAHomecare recommended removing this requirement to allow the physician to prescribe the appropriate device for the patient’s medical needs in the home,” the association said in its comment. “Hospitals utilize different medical devices than what are available for home-based care, and
there is no basis in clinical literature for this requirement.”
And if CMS refuses to make the changes suggested by AAHomecare, the association “would prefer that CMS maintain the existing LCD [local coverage determination] and NCD to ensure that at least the current level of patient access is not further eroded.”
The comments were signed by AAHomecare President/CEO Tom Ryan.
Ryan — along with AAHomecare’s Kim Brummett and Mina Uehara, general counsel Cara Bachenheimer, and other industry leaders — also met with CMS on April 7 to discuss the proposed NCD.
“Given the potential impacts on patient health that could follow from implementing the provisions in the NCD, AAHomecare will continue to engage CMS and Capitol Hill on this issue to help arrive at NIPPV coverage, testing and administrative processes that allow our industry to deliver the most effective care to individuals with significant respiratory challenges,” the association said.
