August 25, 2026
After receiving feedback from members, the association submitted comments to CMS on the proposed rule that includes implementation of the Joe Fiandra Access to Home Infusion Act as well as steps in the agency’s continued focus on fraud and abuse. Following is a brief summary by topic.
Expanding Infusion Under the Joe Fiandra Act
NHIA generally supported CMS’s implementation of the expanded DME benefit for infusion pumps and drugs and agreed with most of the definitions and criteria the agency proposed. However, the association’s principal concern is that the proposed rule does not specify how the need for an infusion pump is determined for drugs that qualify using the new criteria and is silent on how drugs added to the DME benefit will be assigned to categories under the Part B home infusion therapy services benefit. Without that link, patients cannot receive the professional services the statute requires for these drugs to be furnished safely in the home.
NHIA’s recommendation: CMS must describe, in sub regulatory guidance, how drugs added to the expanded DME benefit will be classified under the Part B home infusion therapy (HIT) services benefit; map each drug to the applicable HIT services HCPCS codes; notify DME and HIT suppliers through the DME and A/B MAC weekly updates; and maintain a public crosswalk of DME infused drugs to HIT categories on the CMS Home Infusion Therapy Services website.
Medicare Provider Enrollment and Program Integrity
NHIA also supported CMS’s program integrity objectives but urges CMS to ensure that these expanded enrollment authorities are narrowly tailored to target intentional fraud and abuse while preserving beneficiary access to care. In addition, NHIA strongly opposed revoking enrollment based solely on a provider’s geographic proximity to other providers.
NHIA’s recommendation: The agency should distinguish technical administrative non-compliance from conduct that presents a genuine program integrity risk, give providers notice and an opportunity to cure non-material deficiencies when appropriate, and ensure robust due process and appeal rights before imposing enrollment denials or revocations. This balanced approach will allow CMS to strengthen fraud prevention and protect the Medicare Trust Fund without imposing unnecessary burdens on compliant providers furnishing home infusion, DMEPOS, and pharmacy services to Medicare beneficiaries, particularly in rural and underserved areas.
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NHIA is a trade association that represents companies accredited to provide medically necessary infusion therapies to patients with acute and chronic health conditions, as well as companies that manufacture and supply infusion related products and services. Infusion therapy involves patient-specific compounded medications, supplies, and a range of pharmacy, nursing, and other clinical services for delivering care to patients in the home or suite setting.
NHIA commends CMS for listening to stakeholders and deciding not to move forward at this time with the proposed changes to HCPCS codes and billing units for immune globulin products.
This proposal to modify the criteria for the use of an infusion pump should not be viewed as a solution to the broader access challenges facing Medicare beneficiaries who could safely receive infusion therapy at home.
NHIA submitted comments to CMS on a new proposed rule on interoperability and prior authorization for drugs. While NHIA is mostly supportive of standardizing prior authorization (PA) processes for Medicare-covered drugs, it wants CMS to know that home infusion may not fit neatly into processes designed for medical and pharmacy benefits.
