Rise in home infusion therapy leads to questions on safety, cost

Patient demand, specialty drug availability and workforce shortages have driven increases in home infusion therapy. Health systems and specialty companies can administer prescription drugs intravenously in a home setting to sidestep overhead fees on brick-and-mortar operations and to reserve clinical space for more acute cases. Payers also tout potential savings.

As the practice grows, however, industry watchers are raising questions about whether cost and safety considerations could undermine its possible advantages.

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“Even though the drug and the regimen may be the right thing, some patients aren’t well-suited for home infusion,” said Lisa O’Connor, senior managing director in the health solutions segment at FTI Consulting.

Minding the cost

Around 900 providers and 1,500 pharmacies offer home and specialty infusion therapy to 3.2 million patients annually, according to estimates from the National Home Infusion Association. Clinicians travel to patients’ homes to place intravenous lines and administer treatments, often for chemotherapy, antibiotics or nutrition purposes. Patients are then responsible for maintaining upkeep of the IV line and sometimes self-administering medication between clinician visits, with providers using remote monitoring technology to keep tabs on their physiological conditions.

Before starting the process, providers vet patients based on a variety of factors, such as whether their necessary treatment can be safely administered at the home or whether a patient can correctly use related medical equipment such as infusion pumps and catheters. A clean living space, patient mobility and family caregiver availability also play roles in the decision.

“Not all patients want to be seen in the home, and not all homes are the appropriate site of care for a patient,” said Keith Hartman, CEO of specialty infusion services provider ContinuumRx.

Health systems contacted by Modern Healthcare declined to specify which medications or patient demographics were suited—or unsuited—for home infusion, saying the treatment is individualized. They use it to address chronic conditions such as cancer, gastrointestinal diseases, heart failure, immune deficiencies, hemophilia, multiple sclerosis and rheumatoid arthritis.

The practice translates to possible savings. In the home setting, providers don’t incur overhead costs, meaning no facility fees or ancillary service charges for which patients could be responsible down the line.

“There’s almost no more expensive way to get care than in a hospital-based facility,” said O’Connor.

Registered nurses typically oversee the home infusion process, but in some cases, lower-cost employees such as licensed practical nurses can step in.

“By moving the patients to the outpatient setting and at home, it allows for us to save chairs in the infusion center and save beds in the inpatient [setting], so there are cost savings that way as well,” said Caroline Jones, a clinical pharmacist at Charlottesville, Virginia-based UVA Health.

Some infusion specialists say the at-home model can have diminishing returns, however, especially in rural areas where nurses may not be able to get to patients as quickly.

ContinuumRx is moving away from its original home infusion business model to open more ambulatory infusion clinics with scheduled appointments across its three-state footprint. Nurses doing home visits average three to four patients a day, while those in the clinics average 20 patients over an eight-hour shift, Hartman said, balancing out any overhead costs. About 15% to 20% of ContinuumRx’s patients are treated in the clinics, he said.

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Reimbursement gaps also pose complications. Medicare began offering home infusion therapy coverage as a permanent benefit in 2021. While this has made it easier for more patients to access home infusion treatment, Medicare per-diem rates don’t always account for the rising price tag of drugs and equipment, said Connie Sullivan, president and CEO of the National Home Infusion Association.

For some therapies like parenteral nutrition, where patients are fed intravenously, shortages have raised drug prices by 50% since 2016, according to a 2021 report by the association.

“Cost increases have been really difficult for [the home infusion industry] because our reimbursement for supplies is bundled into a per-day payment that has to cover all the services [and] delivery costs, overhead of running a cleanroom facility, all the supplies you send to the patient for administration, and wages have gone up significantly,” Sullivan said.

Insurance companies should ensure their benefits are keeping pace with industry shifts, she said.

“We need Medicare to catch up and offer a benefit to beneficiaries that’s comparable to what younger patients have,” she said. “Patients that age into the Medicare program and have relied on home infusion for years are shocked to find that they lose their benefits when they turn 65 if they don’t enroll in a Medicare Advantage plan that offers that benefit.”

Commercial insurance payment for home infusion services is typically more well-established, offering fee-for-service reimbursement for supplies, clinical monitoring and pharmacist time with separate payments for drugs and nursing visits. But there can be gaps in some payers’ coverage, said Noah Franz, director of home infusion at Froedtert and the Medical College of Wisconsin based in Milwaukee.

“Not all plans have built in appropriate payments for an alternate site of care such as the home,” he said. “That doesn’t mean they can’t do it, but it’s just not built into their payment model where it makes it feasible … from a financial perspective to take those patients.”

Given the capital and resources required, FTI Consulting’s O’Connor said some providers find it more operationally feasible to partner with third parties that already offer home infusion services, rather than attempting to stand up or expand their own operations. UVA Health, for example, turns to other companies when patients have out-of-network insurance or live in other states.

Keeping patients safe

Some providers view implementation of a home infusion model as too potentially risky, said Dr. Felix Matthews, managing director and national lead for the academic health and research leaders practice at consulting firm Deloitte. Adverse effects, such as extravasation, or when the drug ends up outside of the vein, may not be noticed quickly enough and lead to serious—and costly—health complications.

Patients can also encounter problems if infusion sites aren’t cleaned properly, or if they experience negative symptoms as a result of the treatment.

Froedtert and the Medical College of Wisconsin’s patients have 24/7 phone access to nurses and a pharmacist in case of such issues, which can also include allergic reactions or infusion site infections, Franz said.

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The system provides home infusion for more than 650 patients, most of whom begin their treatments in a hospital setting to rule out severe side effects before moving to the home. As the home infusion program expands, Franz said the health system is working to offer more specialty infusions for oncology, neurology and rheumatology patients receiving chronic lifelong therapies.

After patients are screened, the health system sends a nurse to the patient’s house to reiterate the care plan and show how to manage the pump and infusion line, Franz said. Patients also receive weekly home visits to reinforce safety precautions like hand hygiene, sterilization and infusion site cleaning.

If a problem can’t be solved with a call, the health system typically sends out a clinician or, in cases of severe issues, directs them to urgent care or an emergency department. Any adverse safety events involving actual or potential patient harm are documented by the pharmacy department’s safety officer through an organizational reporting system. The quality committee determines if follow-up actions are necessary, Franz said. He declined to share statistics, citing the in-progress collection of data.

At Banner Health, based in Phoenix, in-house pharmacists check in with patients virtually or in-person on a weekly basis about treatment plan adherence, said Kim Blandford, senior director of home infusion and home medical equipment services. The system’s clinicians are required to provide patients with a workshop on how to administer the infusions and a handbook with contact information and instructions on what to do if a dose is missed or other things go wrong.

Once the pharmacist hears from the patient about symptoms, cleaning practices and remaining doses, they will review notes from the nurse’s weekly home visit to see if there are any discrepancies, Blandford said.

“The nurses know they can always call the pharmacist and vice versa with whatever they need, whatever concerns they have,” she said. “It’s a lot of communication in home infusion, but it works.”

Even with measures in place, some safety professionals are still apprehensive about what they perceive as a lack of broader oversight in home infusion treatment.

The Centers for Medicare and Medicaid Services and the Leapfrog Group do not include data from home infusions as part of their quality reporting.

“We really don’t have any good idea of what the true impact is with infections in this arena because [hospitals] are not mandated to report anything,” said Patricia Jackson, president of the Association for Professionals in Infection Control and Epidemiology.

Jackson also noted the need for individuals dedicated to preventing healthcare-associated infections to be involved in home infusion settings, especially when agencies are providing the treatments.

Although hospital staff undergo training to monitor patients for central line-associated bloodstream infections, a qualitative study published in the American Journal of Infection Control of five major home infusion therapy agencies found that many staffers did not report formal training on this type of infection monitoring. Instead, most learned on the job or relied on prior experience.

Clinicians who participated in the study cited the need for resources like user-friendly toolkits and access to professional development opportunities related to infection prevention.

Still, some research points to increased safety benefits. A 2022 qualitative study by CMS on intravenous immune globulin therapy for more than 2,000 patients cited reports that in-home therapy led to better treatment compliance, fewer missed doses, reduced risk of infection and improved infusion monitoring by clinicians.

Despite hurdles, healthcare experts expect home infusion to keep gaining traction, as the rewards of savings and patient convenience outweigh the risks in many cases.

Deloitte’s Matthews said a mail-order pharmacy model could extend to specialty home infusion drugs if safety and regulatory concerns are addressed, including whether a patient can safely self-administer treatment or whether the drug will be stored properly in transit.

Home infusion could also expand beyond chronic disease treatments into post-acute care services, said So Yeon Kang, a doctoral candidate of health policy and management at the Johns Hopkins Bloomberg School of Public Health who previously worked in the pharmaceutical industry and has published research in several journals on pharmaceutical policy and manufacturers’ behaviors.

She said insurers, consulting agencies and tech companies may see home infusion as an attractive market—though they’ll need a solid understanding of all aspects of the business to be successful.

“Certainly there is a great opportunity for these [disruptor] companies,” Kang said. “Several years ago, [the industry’s] definition of provider was very strict … but now we see a lot more flexibility around the definition of the providers and the payment policy.”