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Fixing Medicare’s Part B HIT Services Benefit

While Congress intended to create a comprehensive Medicare home infusion benefit for Part B DME drugs in the 21st Century Cures Act, flawed implementation by CMS has led to major access issues for Medicare beneficiaries.  The Preserving Patient Access to Home Infusion Act would restore congressional intent and promote access to home-based care by mirroring the successful model employed by nearly every commercial plan.

Legislative Background

  • Certain patients with serious infections, cancer, heart failure, immune system diseases, and other conditions who need IV therapies, can receive their medications in their own home rather than institutional settings such as a hospital or nursing home.
  • When given the option, patients overwhelmingly prefer to receive their infused drugs at home, where they are most comfortable and can resume their personal and professional lives. Additionally, research shows that 98% of patients who receive their infusions at home are highly satisfied with the service.
  • Home infusion has also proven to be highly safe and effective. In fact, studies have concluded home infusion demonstrates clinical outcomes that are as good or better than institutional settings—including lowering rates of infections that present risks in hospitals and other facilities.
  • Commercial payers have long recognized that home infusion is an efficient and cost-effective site of care. As a report from the GAO recently concluded, “providing infusion therapy at home generally costs less than treatment in other settings… and is largely free from inappropriate utilization and problems in quality of care.”
  • The Congressional Budget Office (CBO) has consistently concluded that enhanced patient access to home infusion will create savings for the Medicare program.
  • An analysis from The Moran Company estimates that the bill would save $93M over 10 years.
  • Cost savings generated through commercial plan site-of-care optimization programs are passed on to the patient in the form of lower copays and reduced out-of-pocket costs.
  • Home infusion services are coordinated by specialized pharmacies that meet specific accreditation standards for offering medically necessary infusion therapies in the home. When enrolling a patient in home infusion, the pharmacist works closely with the referring physician and discharge planner to develop a transition plan, facilitate nursing services, and initiate patient and caregiver education.
  • The pharmacist maintains responsibility for the patient 24/7. Their key responsibilities include case management, customizing the medication plan, sterile drug preparation (including clean room operations), clinical assessments and monitoring, coordination with the patient’s other health care providers, delivering equipment and supplies, and providing 24/7 patient support.
  • A nurse conducts periodic in-person visits to educate the patient, perform physical assessments, and maintain the vascular access device.
  • Congress included provisions in the 21st Century Cures Act and the Bipartisan Budget Act of 2018 requiring CMS to create an infusion services benefit for Medicare Part B DME drugs. The intent of the legislation was to ensure all services (i.e., pharmacy and nursing) required to facilitate safe infusions in the home would be supported by a daily payment to the pharmacy for each day an infusion occurs.
  • In implementing this legislation, however, CMS issued regulations that limit reimbursement to days when a nurse is physically present in the patient’s home rather than each day the drug is infused. In practice, the physical presence requirement only acknowledges face-to-face visits from a nurse—failing to account for the extensive services provided remotely by a pharmacist.
  • As Congress has pointed out in multiple letters to the agency, “this physical presence requirement contradicts [the] intent in drafting and enacting this legislation and makes the reimbursement required by the bill inadequate.”
  • A report issued in February 2023 by CMS concludes there has been low utilization of Medicare’s home infusion therapy (HIT) benefit

– On average, only 1,250 beneficiaries are receiving Part B HIT services per quarter—a small fraction of the patients eligible for the service, and an anomaly compared to the over 3 million patients that receive home infusion therapy on an annual basis.

– Due to CMS’ policy, utilization of the benefit decreased during the public health emergency despite an increase in utilization amongst commercial and other government payers.

  • CMS’ report also reveals that only a small portion of eligible providers are participating in the benefit. Just 65 providers billed for HIT services in Q1 2022, despite there being nearly 1,000 home infusion pharmacies, 11,000 home health agencies, and a wide range of other providers capable of providing these services.

Our Solution

NHIA has drafted legislation with the help of our Congressional champions to permanently fix the Part B home infusion therapy services benefit. The legislation (S.2652; H.R. 5067), first introduced in August 2021 (and pending re-introduction in 2023), will accomplish the following if passed:

  • Require CMS to pay home infusion providers for professional services each day the drug is administered.
  • Remove the requirement that a skilled professional be present in the home for billing to occur.
  • Define the covered pharmacy professional services.

If passed, this legislation would restore congressional intent and encourage patient access to home infusion, consistent with the successful model employed by nearly every commercial plan.

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