Will Home Infusion Become an Asset or a Battleground?

Dawn Holcombe, MBA, FACMPE, ACHE
Editor-in-Chief
President, DGH Consulting, South Windsor, CT

Over the past several decades, we have seen the delivery of chemotherapy shift from the hospital inpatient setting to the hospital outpatient setting to the specialized community practice setting. Now, amid the many seismic changes that have been occurring as a result of the COVID-19 pandemic, a battle has emerged over the question of whether a patient’s home should be a site of care for the infusion of certain chemotherapy drugs.

A Highly Regulated Industry

Historically, the home infusion industry has made it possible for other types of drugs to be administered in the home setting, through a combination of pumps and professional services. Each year, the National Home Infusion Association (NHIA) advocates for expansion of Medicare coverage and policies regarding home infusion therapy services. On October 31, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-1711-FC) with a comment period updating transitional payment rates for home infusion therapy services for the 2020 calendar year. This rule also finalized beneficiary eligibility requirement and payment provisions to be implemented in 2021, as required by the 21st Century Cures Act (Cures Act).1 Under this rule, a home health agency that did not have the staff required to furnish in-home skilled services for the safe and effective administration of a transitional home infusion drug was not allowed to bill for a non-homebound patient receiving the drug.

Section 5012 of the Cures Act created a separate Medicare Part B benefit category under Section 1861 of the Social Security Act, subsection (s)(2)(GG), for coverage of home infusion therapy services for certain drugs and biologics (including a payment category 3 for some chemotherapy drugs and biologics) through the use of a pump that is an item of durable medical equipment. This benefit is effective as of January 1, 2021.2 CMS intended to monitor these home infusion therapy services to collect data on the safety and access to care effects of these services.3

Pandemic-Driven Opportunity?

On April 6, 2020, CMS published an interim final rule with a comment period that outlined policy revisions in response to the COVID-19 Public Health Emergency.4 Starting on March 6, 2020, Medicare temporarily relaxed the provisions for home infusion therapy services related to the definition of “homebound” patients, billing, contracts with physicians, remote monitoring, and coverage determination. As the nation’s largest payer, the parameters and boundaries that Medicare has set on the provision of chemotherapy in the home have created a significant damper on the issue of shifting chemotherapy care to home infusion. With the relaxation of these rules, albeit under extraordinary circumstances, the question of home chemotherapy delivery has now become a very hot topic.

Recently, the NHIA announced that the CMS changes regarding home infusion therapy services do not go far enough, and that Medicare beneficiaries are being denied access to less costly home infusion therapies and forced into more costly infusion sites of care. According to the NHIA, “Medicare’s fee-for-service program (Parts A, B, and D) is the only major health plan in the country that has not recognized the clear benefits of adequately covering provision of infusion therapies in a patient’s home.”5 The association has several talking points regarding CMS policy, including the following:

“Patients with serious infections, cancer, heart failure, immune system diseases, and other conditions can receive treatment at home, where they are comfortable and can resume their personal and professional activities…. In 2018, CMS undermined the policy created by Congress [the 21st Century Cures Act] by issuing restrictive 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.”6

The NHIA supports H.R. 6218, the Preserving Patient Access to Home Infusion Act, a bill that was introduced in the US House of Representatives on March 12, 2020, which expands payment for home infusion therapy services whether or not a qualified home infusion therapy supplier was physically present in the home on the day billed.

Ongoing Concerns

While NHIA and other agencies are seeking expansion of home infusion therapy services to include chemotherapy, some physicians are seeking to limit the scope of chemotherapy infusion in the home. On April 8, 2020, the Community Oncology Alliance (COA) published the following statement opposing the delivery of chemotherapy in the home:

“Home infusion by a provider–who may or may not be a trained oncology nurse–and may not recognize and be prepared to treat any adverse reactions–whether simple, significant, or even lethal–that may occur as a common part of an infusion of cancer drugs is of significant concern. 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.”7

The COA cites the fact that chemotherapy treatments are among the top entries for spontaneous adverse drug reports in the FDA Adverse Event Reporting System. It also references the importance of having a team of oncologists, nurses, pharmacists, and even social workers available to manage serious infusion reactions and ensure patient safety, adding that such teams are not available in the home environment.7

Some Steps in the Right Direction

The National Comprehensive Cancer Network (NCCN) issued a Best Practices publication (revised as of March 31, 2020) that listed guidance for transitioning certain oncology treatments from the inpatient to the outpatient setting.8 On April 9, 2020, the agency shared new guidance for optimal cancer management during the COVID-19 crisis, which included converting in-person visits to telemedicine visits when possible; switching from infusional therapy to oral oncolytics if an equivalent formulation is available; and transitioning outpatient care to care-at-home whenever possible (eg, pump disconnection, administration of growth factors at home).9

In the meantime, other providers are embracing the chemotherapy home infusion concept. In the fall of 2019, the University of Pennsylvania, Philadelphia, launched Cancer Care at Home, a pilot program for home-based chemotherapy delivered through its own Penn Home Infusion Therapy program by a hospital-employed oncology-trained nurse. Within 6 months, 40 patients had been treated in the pilot program. Then came the COVID-19 pandemic and along with it, mandated travel restrictions. In the span of 5 weeks (from the beginning of March 2020 to April 7, 2020), 175 patients were treated in the program. More chemotherapies were added, which brought the total to 7 treatments, and more are under review.

“We are not the pilot anymore–we’re the standard of care,” said Amy Laughlin, MD, a hematology-oncology fellow involved with the program, in a recent interview.

Cancer Care at Home uses a series of criteria for determining which chemotherapy treatments may be appropriately added to the home-based program, including whether the patient has previously tolerated the therapy; the stability of the drug to temperature and movement for transport and use in the home setting; if there is a low level of toxicity that can be readily managed in the home setting; and if the patient is capable of following a medication chart. The first 2 regimens deemed appropriate for use in the home setting were etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone for lymphoma, and leuprolide acetate injections for either breast or prostate cancer. Regimens recently added to the program include bortezomib (Velcade), lanreotide (Somatuline Depot), zoledronic acid (Reclast), and denosumab (Xgeva). More than a dozen other regimens are currently under review, and it is likely that rituximab and pembrolizumab for lung cancer and neck cancer will soon be added.10

Before the COVID-19 crisis occurred, the world was moving rapidly in the direction of value-based care, with an emphasis on determining the right setting for the right care at the right time. Identifying alternative sites of care was a challenge, given the payer coverage policies for reimbursement at the time, especially for care in the home. There was, however, a conventional “wisdom” that home care should be less costly than other settings and may be a growth market. Commercial health plans, medical benefit managers, and their partners have already sought to encourage transitions to lower cost sites of care by offering reduced patient cost-sharing or prior authorizations that favor preferred sites, changing benefit structures to support certain sites of care, and using white-bagging to shift utilization of specialty pharmacies.

Home infusion specialty services have been integrated into payer infrastructures and are poised for expansion into chemotherapy. CVS acquired Coram Specialty Infusion Services and advertises chemotherapy infusion therapy as available for safe delivery in the home or at one of its ambulatory infusion suites.

David Wichmann, Chief Executive Officer, UnitedHealth, noted the following in his April 15, 2020, First Quarter Earnings Call:

“The spread of the virus has created a significant health risk for those receiving life-sustaining infusion services traditionally administered in the hospital or hospital clinic settings. For these patients, we’re providing infusion services through our Optum Infusion ambulatory suites and in their homes through our nurse infusion specialists.”11

The COVID-19 pandemic has led to many innovations in healthcare, and although we have seen temporary policy and coverage adjustments to Medicare and private insurance policies to accommodate the current challenges, the impact of those changes is likely to be far-reaching even after the crisis has passed. In-home infusion chemotherapy may well have reached its coming of age. There are many advantages to receiving care in the home, but it is not a solution for all patients, settings, or treatments. Therefore, we must strive to find an appropriate balance.

Conclusions

My personal belief is that there is a place for home-based chemotherapy infusion for treatments that have been carefully vetted for medically driven criteria and that are delivered by specially trained medical personnel in close contact with the treating physician, for patients in settings that are mitigated for risk. This will probably mean that the locus for home-based chemotherapy infusion must reside in the medical organization treating the patient and under close supervision. It may also mean that chemotherapy should not be delivered in the home by entities with no contractual relationship or oversight by the treating provider, a scenario that may hamper the expansion of home-based chemotherapy infusions by members of the NHIA or payer-owned specialty infusion providers.

It is clear that the battle over the management of treatments for patients with cancer in the home setting is heating up faster than before, and that treating physicians—whether private or hospital-based—will be well served by becoming part of the solution. It will be essential to build criteria and narrow the breadth of potential treatments and regimens that may lend themselves to careful oversight in the alternative home setting. Programs, such as the one at the University of Pennsylvania, together with NCCN guidance, may provide a good start to building the necessary criteria and parameters. We cannot just shut down the potential for home-based chemotherapy infusion. Our patients—and society as a whole—will demand continued expansion into this arena for the purposes of convenience, value, and logical care. The next steps are up to us. We must engage in this dialogue before others take it and run with it in ways that do not protect our patients and their quality of care.


References

  1. Centers for Medicare & Medicaid Services. Home infusion therapy services. February 5, 2020. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview. Accessed May 12, 2020.
  2. H.R.34. 21st Century Cures Act. www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. Accessed May 13, 2020.
  3. Department of Health and Human Services. Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020; notice requirement for non-federal governmental plans. May 14, 2020. https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-10045.pdf. Accessed May 12, 2020.
  4. Federal Register. Medicare and Medicaid programs; policy and regulatory revisions in response to the COVID–19 public health emergency. April 6, 2020. www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf. Accessed May 12, 2020.
  5. National Home Infusion Association. About home and specialty infusion. www.nhia.org/about-infusion-therapy/. Accessed May 12, 2020.
  6. National Home Infusion Association. CMS policy threatens access to home infusion, undermines congressional intent. www.nhia.org/wp-content/uploads/2020/03/CMS_Policy_Threatens_Access_to_Home_Infusion.pdf. Accessed May 12, 2020.
  7. Community Oncology Alliance. COA’s position statement on home infusion. April 9, 2020. https://communityoncology.org/coas-position-statement-on-home-infusion/. Accessed May 12, 2020.
  8. NCCN Best Practices Committee Infusion Efficiency Workgroup. Toolkit: providing oncology treatments in the outpatient setting. Updated March 31, 2020. www.nccn.org/covid-19/pdf/NCCN_Toolkit_Updated_for_COVID-19.pdf. Accessed May 12, 2020.
  9. Cinar P, Kubal T, Freifeld A, et al. Safety at the time of the COVID-19 pandemic: how to keep our oncology patients and healthcare workers safe. J Natl Compr Canc Netw. April 15, 2020. Epub ahead of print.
  10. Mulcahy N. Home-based chemo skyrockets at one U.S. center: major organization opposes concept. April 10, 2020. www.the-hospitalist.org/hospitalist/article/220594/coronavirus-updates/home-based-chemo-skyrockets-one-us-center. Accessed May 12, 2020.
  11. Seeking Alpha. UnitedHealth Group’s (UNH) CEO David Wichmann on Q1 2020 results – earnings call transcript. April 15, 2020. https://seekingalpha.com/article/4337791-unitedhealth-groups-unh-ceo-david-wichmann-on-q1-2020-results-earnings-call-transcript?page=3. Accessed May 12, 2020.

Related Articles

Subscribe to
Oncology Practice Management

Stay up to date with oncology news & updates by subscribing to recieve the free OPM print publications or weekly e‑Newsletter.

I'd like to recieve: