Kicking off an industry update webinar on Dec. 15, Tom Ryan, president/CEO of the American Association for Homecare (AAHomecare), had two messages.
The first: The home medical equipment (HME) industry’s campaign to change the home health proposed rule — which will restart Medicare competitive bidding — was unprecedented and scored major wins.
Second: Much work still remains to protect beneficiary access to the medical equipment and supplies they need.
“Yes, we may have destroyed the asteroid that was headed to Planet HME, but let’s be clear — the fight is not over,” Ryan told stakeholders during the webinar. “The threat is still there out there, and it’s aimed directly at patient access.”
An all-out industry effort
“This competitive bidding campaign wasn’t just big, it was bold, it was strategic,” Ryan said of industry efforts that began when the home health proposed rule was published July 2 in the Federal Register and continued during and after the public comment period ended in August. “It was disciplined and effective. We showed the nation what happens when our industry speaks with one voice and invests in coordinated advocacy. We prove we can move the needle in Washington.”
Most notably, CMS’s next Medicare competitive bidding round will feature a slimmed-down list of product categories.
“CMS not including the 13 legacy product categories in this next round of competitive bidding did not come in a vacuum,” Ryan said. “This was the most ambitious advocacy campaign our industry has ever mounted, combining lobbying, grassroots mobilization, public relations on an unprecedented scale. We weren’t just reacting, we were shaping the narrative, coordinating across stakeholders, driving policy conversations at the highest levels.”
Ryan added that AAHomecare spent more than $2 million on the campaign, “not just lobbying, but media outreach, coalition coordination and grassroots activation. That investment translated into more than 35 million media touches, a level of visibility that helped elevate our message far beyond the Beltway. We worked part tirelessly to align the industry’s voice, ensuring our legislative and regulatory requests were consistent, credible and reinforced across all channels.”
Despite the successful exclusion of continuous positive airway pressure (CPAP) devices, oxygen, standard manual wheelchairs, and other categories long associated with competitive bidding, AAHomecare executives emphasized that the final rule does contain policies that threaten beneficiary access.
Webinar speakers criticized CMS’s new Remote Item Delivery (RID) process that seeks to slash the number of suppliers currently providing, for example, urological supplies, ostomy supplies and off-the-shelf braces. Hundreds of suppliers now serve Medicare beneficiaries in each of those product categories. The RID process could lower that number to fewer than 10 per category.
“This so-called RID category is nothing more than a consolidation scheme,” Ryan said. “It threatens to strip away choice, limit innovation and put patients at risk. We will not stand by while access is jeopardized to every stakeholder in these product categories. Know this: We are focused, relentless, back on the field with passion and a plan.”
Mina Uehara, senior director of regulatory affairs for AAHomecare, said the competitive bidding fact sheet — originally released on the same day as the final rule — was “later updated” by CMS “to clarify that only new remote item delivery products will be included in the next round of bidding. So this means that legacy items, such as oxygen, wheelchairs and hospital beds, which were part of the previous competitive bidding rounds, will not be included.”
Webinar speakers later confirmed that enteral nutrition and supplies, which have been competitively bid in the past, are excluded from the next bidding round.
But ostomy and urological supplies — as well as, possibly, tracheostomy supplies — are now in.
“And this is a significant change,” Uehara said. “It is important because medical supplies have traditionally been excluded from the competitive bidding program, and by redefining medical equipment to include these supplies, CMS is now creating a pathway for them to become eligible for competitive bidding moving forward.”
New product categories
Kim Brummett, AAHomecare’s senior vice president of regulatory affairs, said the association is “compiling questions and clarifications” for CMS, including the question of whether tracheostomy supplies are included — and how they will be included.
“I think the only option at this point would be for CMS to include [tracheostomy supplies] in the ostomy supplies product category,” said Cara Bachenheimer, an industry policy expert and shareholder at Brown & Fortunato. “The only reason we suspect that is because CMS, when they redefine their definition of items to be included, they basically say, ‘Tracheostomy supplies are just like ostomy supplies. So we don’t have to, in our regulatory text, separately identify them.’”
CMS is also including continuous glucose monitors (CGMs) on its product categories list.
“CMS has made clear their intention to include CGMs and to reintroduce insulin pumps into competitive bidding program,” Uehara said. “Specifically under the new RID competitive bidding program, the final rule outlines how CMS will bring these product categories into [the] future bidding round, and the proposed approach is a significant shift from what we see today when including these items.
“CMS intends to change the payment category for CGMs and insulin pumps. So today, CGMs are paid as an inexpensive or routinely purchased item, and insulin pumps as a capped rental item. Under the RID competitive bidding program, CMS will reclassify them both as ‘frequently and substantial servicing items’ (FSS). What that means in practice is that CGMs and their supplies, as well as insulin pumps and their associated supplies, will move to a bundled, ongoing rental payment model, and under the structure, the supplier will retain ownership of the device, rather than the patient owning it.”
Uehara said CMS has expressed interest in combining CGMs and insulin pumps into one product category, which raises additional questions.
“This is unique because they are under distinct policy areas, so separate LCDs [local coverage determinations],” Uehara said. “We have really not seen this before, with the legacy items and in the market. Currently, many suppliers furnish one product but not the other. So combining them into a single category [and] requiring the winner to provide both products is just a major departure from what we see today in the market. CMS further notes that if CGMs and pumps are combined into one product category, CGMs would serve as the lead item.”
Uehara adds that CMS will be keeping an eye on the reimbursement rates that result: “While Class III CGMS are excluded from competitive bidding, CMS makes it clear in the final rule that it intends to use the Class II CGM competitive bidding rates as a reference point to ensure payments for Class III CGMS are not significantly higher. Based on its claims analysis, CMS anticipates awarding approximately seven to 10 suppliers per medical supplies product category nationwide.”
Next advocacy steps
Jay Witter, senior vice president of public policy at AAHomecare, thanked webinar attendees for “participating in this massive campaign. As Tom indicated at the beginning — the level of support of the industry, all the groups, the financial commitments, but also the work and using relationships to advance our cause were tremendous. It was a 24/7 advocacy effort, and I’m proud to say that everybody had a piece of it, from small providers to huge manufacturers to other groups.”
Witter also thanked industry organizations from the Advanced Medical Technology Association (AdvaMed) to the Council for Quality Respiratory Care (CQRC) and the National Coalition for Assistive & Rehab Technology (NCART).
And while conversations didn’t go smoothly with all policymakers, “We’ve discovered a lot of allies in the administration that were concerned about moving forward.”
As for next advocacy steps: “Obviously, it was a relief that the 13 legacy items categories were not included, but it was devastating that they continued to move forward with very little change [from the proposed rule] to ostomy, urologicals, CGMs and the accreditation requirements [and] enrollment requirements,” Witter said. “So once we had analyzed the impact of the regulations, we started working with our folks, with our leadership, working with other groups on a legislative, political path forward. And there is a path forward.”
Advocacy efforts could include new legislation, hearings, Congressional letters and Congressional meetings. “Thank you for all your past work,” Witter said. “But the work is not over.”
Ryan added that consumer stakeholder groups, including the ITEM Coalition, are “very, very much aligned with us that this program, as finalized, is devastating to access. So they’ll be great advocates for us, and we’ll be working with those groups to continue to make sure we’re all going in the right direction.
“We want to take the lead that we are a constructive partner. We’re here to work together. But there are certain things that [CMS] has done that are just devastating. As I said, we’re rolling up our sleeves. We’re determined, we’re resilient, we’re fighting even harder.”
