Medicare Limits Cancer Patients’ Access to Home Infusions. A New Bill Could Change That.

Home infusion of cancer treatments has gained traction in some pockets of the United States over the last few years, but reimbursement and benefit design within fee-for-service Medicare are creating barriers to greater use, according to proponents of cancer care at home.

Penn Medicine, which launched its Cancer Care @ Home program in 2019, administers about 5% to 10% of all cancer infusions or injections in patients’ homes.

However, that number could go as high as 20% while maintaining safety and effectiveness, according to Justin E. Bekelman, MD, an oncologist and director of the Penn Center for Cancer Care Innovation in Philadelphia.

Dr Bekelman explained that one of the barriers to expanding the Penn program, and to uptake of home infusion by other providers, is that Medicare covers most at-home cancer treatments through the Part D drug benefit.¹ This leaves patients with significantly higher out-of-pocket costs than if they received treatment in an ambulatory or hospital setting, which is covered under Part B.

“It’s not purposeful. It’s just a switch between government benefit design programs,” Dr Bekelman said. “We need creative solutions such that home cancer care and programs like it that are so patient-centric are not inadvertently disincentivized by reimbursement or benefit design issues.”

Medicare Home Infusion Benefit

Private insurers in the under-65 age market have embraced coverage of home infusions, but fee-for-service Medicare coverage is limited, said Connie Sullivan, BSPharm, president and CEO of the National Home Infusion Association (NHIA) in Alexandria, Virginia.

“For the most part, you don’t have the option to just choose home [care], even if it’s what works best for you because Medicare does not have a comprehensive benefit around your catheter supplies, the pump that’s needed, administration supplies, tubing, flush syringes, and then all the work that happens at the pharmacy to acquire the drug, prepare the drug, and coordinate with everybody who has to be involved,” Sullivan said. “It’s a benefit in name only.”

Although most cancer drugs administered at home are covered under the Part D drug benefit, the 21st Century Cures Act created a Medicare home infusion therapy benefit that covers the professional services for certain drugs and biologics administered either intravenously or subcutaneously through a pump.^1,2 The benefit, which went into effect in January 2021, covers nursing services, training and education, remote monitoring, and other monitoring provided by a qualified home infusion therapy supplier.

Overall, the benefit covers 34 drugs for home infusion, including 8 chemotherapy drugs.³ The most commonly provided chemotherapy treatment under the benefit is fluorouracil.

Proposed Legislation Could Close Coverage Gaps

Uptake of the Medicare home infusion therapy benefit by providers has been low, Sullivan said, because the benefit does not include coverage of pharmacy services or professional service fees on days when nurses are not physically present at the home.

Sullivan said NHIA is supporting proposed federal legislation that seeks to close some of those reimbursement gaps. The bill is called the Preserving Patient Access to Home Infusion Act (H.R. 4104/ S. 1976), and it was introduced by a bipartisan group of lawmakers in the US House and Senate in June.⁴

The Preserving Patient Access to Home Infusion Act would establish pharmacy services as part of covered home infusion therapy under Medicare, direct the Centers for Medicare and Medicaid (CMS) to pay 50% of the nursing rate on home infusion days when a nurse is not present, and allow nurse practitioners and physician assistants to set and review plans of care.

If the legislation is passed, Sullivan said, it would likely encourage more providers to participate in the benefit. She is optimistic about the bill’s chances of being included in an end-of-year congressional budget package.

“It really comes down to [Congressional Budget Office] scoring in this environment,”  Sullivan said. “We feel confident that, if it comes back as something that saves the program money, that it could very easily be included in an end-of-year package.”

Opposition to Home Infusion

While the Preserving Patient Access to Home Infusion Act has the support of several patient organizations, as well as provider and pharmacy groups and health systems, the Community Oncology Alliance (COA) opposes efforts to increase home infusion of cancer therapies.⁵

The COA became concerned when home infusion took off during the first year of the COVID-19 pandemic, said Ted Okon, executive director of COA in Washington, DC.

The COA’s board of directors approved a position statement at that time opposing home infusion of chemotherapy, cancer immunotherapy, and supportive drugs for cancer patients due to a lack of support to handle potential adverse events.⁵

COA’s statement argues that a team of nurses, oncologists, pharmacists, and even social workers is needed to manage serious infusion reactions, and such a team is not available with home infusions.

“Many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening,” the COA statement reads. “Home infusion negates the benefits of the expertise and team approach to cancer care, which are the hallmarks of community oncology, within facilities specifically designed for safe and effective cancer drug infusion.”

Okon noted that a home care team would not have the time or expertise to respond to a rapid-onset cardiac event, for example. There are additional concerns, he added, such as ensuring that medications are kept at appropriate temperatures in extreme heat and can be properly stored in the home, as well as ensuring the safety of nurses or other providers who could be targeted as they transport expensive therapies.

“This is meant to be done under physician supervision in a facility that can handle it,” Okon said. “It’s that simple.”

Appropriate Use

Health systems that perform home infusions emphasize their record of safety and the numerous safeguards they put in place.

Duke Health’s home infusion program has been operating since the 1990s and currently operates in North Carolina, South Carolina, and Virginia. The program relies on its Pharmacological and Therapeutics committee, which includes pharmacists, RNs, and MDs, to review each medication before use in a home setting, considering black box warnings, drug-drug interactions, and specifics of administration such as infusion rates and monitoring parameters.

Additionally, all nurses receive special training that is refreshed annually, and patients are sent home with anaphylactic kits when receiving first-time doses in the home or specialty medications like monoclonal antibodies and intravenous immunoglobulin, according to Lisa Tuttle, RN, assistant chief nursing officer and senior director of clinical operations at Duke HomeCare & Hospice in Durham, North Carolina.

Tuttle said that, from July 2022 through June 2023, Duke administered infusion therapy to 2738 patients, with 497 patients receiving chemotherapy. Six patients (0.22%) had a therapy-related adverse event that resulted in a return to the hospital.

“We don’t have a lot of infusion patients readmitted to the hospital, and I think that’s because of all the education that’s provided to patients and caregivers by our infusion team,” Tuttle said.

At Penn Medicine, the focus is on making sure that both the patient and the medication are appropriate for at-home administration, Dr Bekelman said. For instance, if a patient has previously had an adverse reaction to a medication, they might be considered at higher risk and receive therapy in the clinic.

Clinicians also consider the side effect profile of the medication in question and whether any adverse events can be safely handled in the home; for example, with an anaphylaxis bag. In addition, clinicians consider the mechanism of transport and delivery to the home, the storage at the home, and the ability to deal with potential medication spills.

The ability to give treatments at home has the potential to dramatically increase access for patients who might otherwise find it difficult to come into the clinic, Dr Bekelman said, but it is never going to replace administration in the clinic or the hospital.

“This is not a wholesale substitution,” he said. “This is an important option that more patients across the US need access to for important reasons.” 

Disclosures: Dr Bekelman reported consulting work for Reimagine Care. Sullivan, Okon, and Tuttle have no relevant disclosures aside from their employment.

References

1. Medicare coverage of cancer treatment services. Medicare.gov. Accessed August 14, 2023.

2. Home infusion therapy services. Centers for Medicare and Medicaid Services. Accessed August 14, 2023.

3. HIT monitoring report. Centers for Medicare and Medicaid Services. Published February 2023. Accessed August 14, 2023.

4. H.R. 4104. The Preserving Patient Access to Home Infusion Act. Congress.gov. Accessed August 14, 2023.

5. COA’s position statement on home infusion. Community Oncology Alliance. Published April 8, 2020. Accessed August 14, 2023. 

This article originally appeared on Cancer Therapy Advisor