When Will Recalls, Competitive Bidding and Public Health Emergency End?

PHOENIX, Arizona (April 5, 2022)—The three biggest issues facing home medical equipment (HME) providers in the coming year are really holdovers from 2021: the continuation of Philips Respironics’ device recall, the open-ended fate of competitive bidding and the question of when the public health emergency will end, experts said at Medtrade West.

And there aren’t significant answers to any of those three items, Cara Bachenheimer and Jeff Baird said in a presentation at the conference.

“To be honest, there’s no great update,” Bachenheimer, who is head of the Government Affairs Practice at Brown & Fortunato, said in reference to Philips’ recall of CPAP and other devices, which was announced mid-2021. “Philips is plodding through the process. It is a long process… This is going to be a long slog; the newest estimate is by year-end, things will be resolved.”

Bachenheimer and Baird, who is chairman of the Health Care Group at Brown & Fortunato, addressed attendees at Medtrade West on “Hot Button Legal Issues Facing DME Suppliers in the Next 12 Months.” 

She encouraged providers to check the Food and Drug Administration website every few week for updates. She also said that if providers are using devices that have temporary FDA approval due to the public health emergency (PHE), they should be in close communication with the manufacturer on their plans for full approval after the PHE comes to a close.

Question marks are still swirling about when that will happen. Earlier this year, there were rumors it might close in July, but now that has come into question.

Experts are also trying to read the tea leaves on plans by the Centers for Medicare & Medicaid Services (CMS) to launch a new round of Durable Medical Equipment, Prosthetics, Orthotics and Supplies competitive bidding program in 2024.

“CMS will not tell you anything officially,” Bachenhemer said. “Unofficially, several months ago they indicated they’d be changing the program.” But what that change means—and when it might happen—is unclear. Bachenheimer said that in the past, the Centers for Medicare & Medicaid Services have usually made an initial announcement about the program in the first week of March—four weeks earlier than now. And if there’s not a proposed rule by July or August, it’s unlikely there will be one.

“I know it’s not a lot of crystal clarity but that’s sort of the way with a lot of these policy issues in D.C.,” she said.