The National Home Infusion Association (NHIA) says the July 1 prospective payment system rate update is a step forward in recognizing home infusion providers’ expertise — but fails to resolve “broader access challenges facing Medicare beneficiaries who could safely receive infusion therapy at home.”
NHIA’s statement on July 2 followed the Centers for Medicare & Medicaid Services’ (CMS) proposed “Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS),” released July 1.
A CMS fact sheet also released July 1 said about home infusion, “CMS is proposing to amend the definition of durable medical equipment (DME) at 42 CFR 414.202 to implement Section 6222(a) of the Consolidated Appropriations Act, 2026 (CAA, 2026), which expands coverage under the DME benefit to certain external infusion pumps and associated home infusion drugs that would be considered appropriate for home use if certain criteria are met, such as the requirement for the drug to be administered by or under the supervision of a healthcare professional. The effective date of this provision is April 1, 2027.”
Defining home infusion healthcare professionals
The proposed rule recommends changing “the definition of DME at section 1861(n) of the Act to include coverage of external infusion pumps and associated home infusion drugs (as defined in subsection (iii)(3)(C) of the Act) or other associated supplies” that do not meet the “appropriate for use in the home requirement applied to the definition of DME under §414.202 if the following criteria added as new paragraphs (1), (2), and (3) of Section 1861(n) of the Act are satisfied.”
The criteria are that the prescribing information approved by the U.S. Food & Drug Administration (FDA) for the home infusion drug associated with the infusion pump “instructs that the drug should be administered by or under the supervision of a healthcare professional; that a qualified home infusion therapy supplier administer or supervise the administration of the drug or biological in a safe, effective manner within the patient’s home; and that the prescribing information indicates that the drug should be infused at least 12 times per year intravenously or subcutaneously, or at infusion rates that the secretary of the U.S. Department of Health & Human Services (HHS) determines would require the use of an external infusion pump.”
The proposed rule also discusses the definition of “healthcare professional” affiliated with home infusion treatments and recommended that those professionals be defined as “a registered nurse, clinical nurse specialist, nurse practitioner, physician assistant or physician. In addition, we are proposing that the requirement that the drug be infused at least 12 times per year means at least once per month to reflect how dosing of drugs is normally prescribed.”
NHIA responds to proposed changes
NHIA said it appreciated “CMS’s recognition … that registered nurses and other qualified clinicians are well equipped to safely manage the monitoring and potential adverse effects associated with infusion therapies furnished in the home. This acknowledgement reflects decades of clinical experience demonstrating that home infusion providers routinely deliver complex intravenous medications safely through comprehensive patient assessment, education, monitoring and coordination with prescribing clinicians. CMS appropriately reinforces what home infusion providers, physicians and patients have long known — that clinically appropriate infusion care can be delivered safely in the home with qualified healthcare professionals overseeing patient care.”
But the proposed rule falls short, NHIA said, of removing obstacles that prevent too many Medicare beneficiaries from receiving home infusion therapy.
“The overwhelming majority of Medicare beneficiaries continue to lack meaningful access to home infusion because of fundamental flaws in the Medicare home infusion benefit,” the NHIA statement said. “As a result, thousands of beneficiaries receiving intravenous anti-infectives, hydration, immune globulin, biologics and other infused medications continue to be directed to hospital outpatient departments and skilled nursing facilities despite home infusion often being the clinically appropriate, lower-cost and patient-preferred setting.”
NHIA compared commercial insurers’ policies on home infusion to Medicare’s.
“The limited impact of this proposal underscores the much larger disparity that continues to exist between Medicare and the commercial insurance market,” NHIA said. “Today, over 350 infused drugs are routinely administered safely in patients’ homes under commercial insurance coverage. By contrast, CMS acknowledges in the proposed rule that only a single drug is expected to newly qualify for Medicare coverage under the revised external infusion pump criteria. While NHIA supports expanding access for any beneficiary who may benefit from this policy, the proposal fails to meaningfully narrow the significant access gap between Medicare beneficiaries and commercially insured patients.”
NHIA continued to urge Congress to enact H.R. 2172 and S. 1058, the Preserving Patient Access to Home Infusion Act bills currently in the U.S. House and Senate.
“Passage of this legislation would substantially expand access, improve patient choice, reduce unnecessary utilization of higher-cost sites of care, and better align Medicare policy with today’s clinical standards,” NHIA said.
Connie Sullivan, NHIA’s president/CEO, answered questions about the capabilities of home infusion for Medicare beneficiaries during a Jan. 8 U.S. House Energy & Commerce Health subcommittee meeting.
“Every year, over a million patients rely on home infusion to treat serious infections, immune disorders, cancer, heart failure and other complex conditions,” Sullivan told subcommittee members, adding that receiving infusion treatments at home “is strongly preferred by patients because it helps them get the IV medications they need with the least disruption to their daily lives, allows earlier discharge from the hospital, and lowers the risk for complications such as drug-resistant infections. Home infusion is a mainstream part of modern health care delivery.”
