Approaching Medicare's New Infusion Benefit

CMS has deemed a new infusion benefit that can be an opportunity for DME pharmacies. But it's important to understand how the benefit works and how accreditation plays a role.

Effective Jan. 1 of this year, Medicare began covering the provisioning of infusion therapy-associated services and devices in the home. This has created new opportunities for DME pharmacies that have long been providing care and DME items to homecare patients in their communities.

So what makes home infusion so unique? Many infusion therapies are provided by a specialist provider’s office or in an ambulatory infusion center, but for many homecare patients, ambulatory infusion is difficult or not desirable, so home infusion therapy is available.

However, up until this year, Medicare did not cover home infusion therapy services. The 21st Century Cures Act changed all that. Signed into law in December 2016 by then Pres. Obama, the Act said that effective Jan. 1, 2021, Medicare would cover intravenous or subcutaneous administration of drugs or biologicals through a pump that is an item of DME in the home setting. The law added that the new home infusion therapy should include professional services (including nursing services); training and education (not otherwise included in the payment for the DME); and remote monitoring, and other monitoring services for the home infusion therapy.

So how do DME pharmacies interested in this new benefit approach this new benefit?

It begins with understanding the benefit and how to qualify for providing to Medicare beneficiaries, explains Sandy Canally, RN, founder and CEO of accrediting organization The Compliance Team ( says that the new benefit represents a solid opportunity for enterprising DME pharmacies looking to expand their revenues, and the pathway toward tapping into it is not that difficult to negotiate.

The first thing to understand: like being a pharmacy or providing DMEPOS for Medicare, it requires accreditation.

“Providers that want to bill for home infusion and get paid must be accredited by one of the recognized accrediting organizations,” Canally says, adding that her organization, The Compliance Team, is deemed by Medicare for accrediting home infusion. “So, anyone who is interested in getting into that sector of care, you need to make sure that you’ve been dealing with an AO that they are, in fact, recognized by CMS for home infusion.”

It’s important to note that home infusion accreditation has been around a long time (people have obliviously needed home infusion for as long as the care has been around), and there are many AOs such as The Compliance Team, that go way back in accrediting home infusion.

“What has changed is that is a benefit has come into play,” Canally says.

Also, when it comes to this new benefit and infusion care for Medicare beneficiaries, there are three roles that are played in provisioning home infusion that DME pharmacies need to keep in mind:

  • The durable medical equipment element, which is the pump.
  • The drug that needs to be infused, which means a pharmacy needs to be in the mix.
  • The administration of the infusion therapy to the patient, which is typically carried out by nurses.

“Now, any one of those three entities could be the billing provider,” Canally explains. “In which case, the other two might be a subcontractor to that providers. Or, a DME provider or a pharmacy could be the subcontractor to a nursing agency.”

Or, if a DME pharmacy is involved, “They might do it all,” Canally says. “They might have their own nurses, which most of the pharmacies that we’ve accredited for infusion — going back quite a few years — have actually had all of those components.”

(At this point, a light bulb most likely just lit up over your head.)

So for any DME pharmacy that is considering Medicare’s new infusion benefit as a way to drive new revenue and care services, what’s the best way to approach the opportunity. Canally says a solid way to get started is to look for local partnerships. If a DME pharmacy isn’t ready to offer pumps, it could partner up with a local DME provider. Or if it offers the pumps but doesn’t have nurses on staff, then it could partner with a nursing agency that specializes in infusion.

For the accreditation component of the service, Canally says her business looks at all aspects of the business seeking accreditation.

“If you’re interested in home infusion and getting accredited, the one thing that you need to have prior to a visit from the accrediting organization are patients that are actually being served in the home,” she says. “Ambulatory infusion, which a lot of providers do and that we’ve been accrediting for years, does not come into play here. This benefit is only about patients getting infusion therapy in the home.”

This article originally appeared in the DME Pharmacy December 2021 issue of HME Business.