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How New Cancer Treatments and Regulations Will Affect Your Future Facilities


Cancer prevalence is estimated to increase to 26.1 million in the United States by 2040 (Figure 1) along with increases in survivorship. Fueled by advances in the field of immunotherapy and new ways to manage and reduce dangerous side effects, cancer is becoming more like a chronic disease with fewer patients needing ED admission, intensive care, or new treatments. And new CMS regulations are creating incentives to retool how cancer care is delivered. Investing in new facilities like dedicated cancer centers and cancer urgent care clinics becomes a much more prudent endeavor.

Growth of Immunotherapy Programs

Immunotherapy is one of the newest ways doctors and researchers fight cancer. Normally, the immune system has many ways to deal with foreign invaders to the body, such as bacteria and viruses. With cancer, however, the immune system has difficulty targeting cancerous cells as they resemble the body’s normal cells. Immunotherapy is a form of treatment where the immune system is enhanced or re-engineered to function at a higher level. One newer form of cancer immunotherapy treatment involves removing patients’ own T cells, a white blood cell capable of killing foreign invaders, and through a laboratory process, inserting hybrid receptors that can selectively target and destroy cancerous blood cells back into the patients’ T cells. These hybrid receptors are known as Chimeric Antigen Receptors, thus calling the treatment CAR T cell therapy (Figure 2).


One operational challenge to healthcare providers happens before the CAR T cell therapy is administered. In order for patients to receive the treatment, they undergo a version of chemotherapy to prime their immune system. From an operational side, hospitals must align the infusion schedule with the CAR T cell process, which can be difficult to coordinate.


After treatment, CAR T cell therapy can affect the utilization of the hospital’s critical care units. One major side-effect to the therapy is called cytokine storm response, and is actually a sign that the treatment is working well. This is because when the modified T-cells target and destroy the cancerous cells, they create such massive amounts of debris and dead cancer cells that the body’s natural inflammatory response to debris goes into overdrive. This inflammatory response is characterized by a release of signaling proteins, cytokines, and causes difficult to manage side effects, such as fevers, low blood pressure, rapid heartbeat, and hallucinations. Following treatment, either out of necessity or out of precaution, hospitals have been admitting their treated patients to critical care units.


Even if patients do not exhibit dangerous side effects, the FDA, aware of the uncontrolled nature of the treatment, has mandated that hospitals become certified to give this treatment. As part of this certification, patients must remain within 2 hours of hospital where they received treatment for at least 4 weeks following infusion.


This mandate alone is spurring the development of new cancer urgent care centers.


New CMS Incentive to Keep Cancer Patients out of the Emergency Department

The Centers for Medicare & Medicaid Services (CMS) is adding a new claims-based outcome oncology measure, OP-35, to their Hospital Outpatient Quality Reporting (OQR) program. (QualityNet) This measure aims to reduce preventable emergency department (ED) visits and hospital admissions of cancer patients. In 2020, hospitals may be penalized for avoidable visits.

This new measure will:

  • Include Medicare fee for service (FFS) patients who are 18 or older and enrolled in Medicare FFS in the year before their first outpatient chemotherapy treatment.

  • Record the number of patients with an ED visit or hospital admission within 30 days of receiving outpatient chemotherapy by a hospital outpatient department (HOPD)

  • Count patients only if the ED visit or hospital admission is due to one of ten conditions: Anemia, Nausea, Dehydration, Neutropenia, Diarrhea, Pain, Emesis, Pneumonia, Fever, or Sepsis

  • Exclude patients who receive oral chemotherapy treatment and those with a diagnosis of leukemia

As patients may receive chemotherapy from more than one facility, treatment will be counted in each facility’s cohort, and the facility(s) that provides outpatient chemotherapy treatment will be accountable for that patient experiencing a qualifying outcome event within the 30-day window.


How One Health System Is Responding


Froedtert Health and the Medical College of Wisconsin network created a very successful 24-Hour Cancer Clinic (Figure 3). The system recognized that their cancer patients needed more specific care for complications of their disease. A busy ED was not the best option so they launched an after-hours clinic in November 2016 to prevent unnecessary ED visits and hospital admissions. The clinic is staffed by an oncology team to help manage side effects and provide additional treatment or monitoring. Unlike a typical urgent care clinic, the patients cannot arrive without an appointment and must contact their oncologist for instructions.

What You Should Do Now

  • If you do not have a dedicated cancer center now is the time to plan one. As the projections make clear prevalence is growing and regulations are creating incentives to create one. A local, dedicated cancer center will be a necessity.

  • Make your dedicated cancer center as convenient as possible. Ensure that your patients do not have to negotiate the labyrinth of your hospital; they are very sick and making access simple and accessible is a priority.

  • Establish a cancer urgent care clinic as part of the dedicated center

  • Consider creating your own cell manufacturing lab. Systems that treat a large number of patients and are using immunotherapy know that this treatment will grow. While only a few have their own manufacturing lab, several more are planning them to control the quality of the cell stock and access.



Cover Photo: “bispecific-antibodies-myeloma-immunotherapy” Celgene. October 13, 2016. https://www.celgene.com/redirecting-immune-cells-fight-myeloma/

Figure 1: Bluethmann, PhD, MPH, Shelley & B Mariotto, Angela & Rowland, Julia. (2016). Anticipating the "Silver Tsunami": Prevalence Trajectories and Comorbidity Burden among Older Cancer Survivors in the United States, Figure 1. Cancer Epidemiology Biomarkers & Prevention. 25. 1029-1036. 10.1158/1055-9965.EPI-16-0133.

Figure 2: “CAR T-cell manufacturing process”. June, 2018. https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FSHP1_CART_Factsheet_June2018_FINAL.pdf.

Figure 3: “Froedtert and MCW vistspmonth” AJMC, Walradt, Jessica. September 29, 2017. https://www.ajmc.com/contributor/jessica-walradt/2017/09/expanding-access-and-value-24-7-cancer-clinics.