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CMS proposal threatens entire landscape for home mechanical ventilators


 

CMS announced in a [press release in mid-March that as it revamped the competitive bidding program for durable medical equipment, it would move to include no invasive ventilation (NIV) in the revamped program, slated to take effect January 1, 2021.

While the implementation date is still more than 18 months in the future, the regulatory timetable for a formal announcement, as well as time for CMS to introduce its revamped bidding process, actually creates a relatively short window for aggressive action to thwart the CMS proposal.

In late November 2018, when CMS was seeking public comment on the idea of such a move, CHEST, NAMDRC and numerous other societies submitted strongly worded comments opposed to the recommendation, citing a wide array of clinical risks associated with such a proposal. The comments also highlighted CMS’ total failure to revamp its own coverage policies, frequently cited by the pulmonary medicine community and the Office of the Inspector General as the primary root cause for significant problems.

Background: Under current law, Medicare is required to pay for certain ventilators under a “frequent and substantial servicing” payment methodology, with payment continuing as long as medical necessity is documented. Nearly 2 decades ago, CMS (then HCFA) sought to circumvent those statutory requirements by declaring that some ventilators are really not ventilators (as FDA classifications indicate) but are actually “respiratory assist devices.” The long-term impact of that unilateral policy decision has been ongoing chaos, as well as flawed coverage policies. For example, it is much more challenging for a physician to order a cheaper bi-level device than to order a ventilator for treatment of “respiratory failure.” As there are no limitations or qualifying criteria tied to “respiratory failure,” the community has responded with the path of least resistance while pleading with CMS to restructure their coverage policies to reflect the standards of care for home mechanical ventilation.

Since 2014, the community has repeatedly tried to convince CMS of the importance, and cost savings, associated with such a revamp, to no avail. Given 5 years of well documented efforts, it is likely that the only genuine solution will be a legislative one that forces CMS to behave in certain ways.

The challenges: There are complicating variables that the clinical community will need to address:

1. If the term “ventilator” is included in any legislative effort, CMS could expand its infamous concept “just because FDA calls a device a ventilator doesn’t make it one.” Using particular CPT or HCPCS codes would open the door for CMS to simply change coding to circumvent legislative intent.

2. If a legislative effort receives serious support, it ought to include specific guidance to CMS to force it to change its coverage policies for home mechanical ventilation to reflect standards of care and state-of-the-art devices.

For example, because devices are designed today to serve a wide range of respiratory issues, one device may be used to provide critical life support for an ALS patient, while that same device could also be used to provide nocturnal or intermittent support for other neuromuscular or COPD patients. Because the durable medical equipment benefit is focused on devices, CMS’ move to change to focus from a device to a patient is questionable.

3. Forcing CMS to move in a particular direction regarding coverage and device usage must be flexible enough to allow for technological and medical innovations; after all, no one wants to recommend legislative policies that would have to be revisited to address potential/likely advances in this field.

Broad strategies: While the durable medical equipment community is also challenging this proposal, they agreed that the medical and patient communities should take the lead. And, in principle, we agree. But implementation of that effort is a bit of a challenge as it requires a significant grassroots effort from concerned physicians, as well as patient groups to contact their legislators in Congress. After all, the worst case scenario is for a Senator to say, “How come I haven’t heard from any constituents about this problem if it is as bad as you say it is?” That is a fair and common refrain, and we must be prepared to engage the broad physician and patient communities to ensure success in this effort.

Once there is formal introduction of a proposal to move this matter forward, there will be outreach to physicians and respiratory therapists across the country to urge support of the legislation. Keep watching for such requests for action!

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