- Washington and Public Policy: The COVID-19 Pandemic
- Community Care Providers and COVID-19
- Real-World Evidence Supports Patient Navigation in Cancer
- Oncology Nursing and Cancer Care
- Patient Advocacy During the Pandemic
- Pharmaceutical Manufacturers’ Response to COVID-19
On April 3, 2020, the Association for Value-Based Cancer Care (AVBCC) held a webcast with healthcare experts representing major industry stakeholders to address the impact of the COVID-19 pandemic on oncology delivery systems and the management of patients with cancer. Below are highlights from the AVBCC webcast, representing some of the key presentations. The complete set of articles is available at www.TheOncologyNurse.com.
Jayson Slotnik, JD, MPH, Managing Partner, Health Policy Strategies
Mr Slotnik opened the discussion with an inside look at Washington, addressing some of the changes to oncology care policies and operations from the COVID-19 pandemic. He outlined a quick overview of the initiatives from the Centers for Medicare & Medicaid Services (CMS), including new guidelines and the easing of some restrictions on physicians’ options for telemedicine.
“CMS has done a very good job cataloging all their announcements and initiatives for loosening guidelines to allow patients to still access their physicians,” said Mr Slotnik. He noted that stakeholders from across the industry are focusing on helping patients with cancer gain access to their medicines amid a deeply changed healthcare provision environment. To that end, some experts are working with CMS to issue guidelines on home infusion and physician supervision in the outpatient setting.
“Industry and other stakeholders are helping CMS put out guidelines and instructions, billing guides, whatever they can, to help cancer patients get their drugs in the home and create a more robust home infusion opportunity for patients so they don’t miss any of their life-saving treatments,” Mr Slotnik said.
In addition, there are plans to relax the clinical criteria for drugs administered via durable medical equipment, and an expected broadening of the definition of “home-bound.” He is expecting the release of additional guidance on how to set up home infusion, a series of expanded frequently asked questions, and details on how providers should bill for a variety of arrangements that allow patients to continue to receive treatments at home. Mr Slotnik encouraged listeners to reach out to their legislators with ideas on how to broaden access for patients.
Scott Gottlieb, MD, Former FDA Commissioner
Dr Gottlieb provided an assessment of where the pandemic is heading over the next weeks. He started his discussion with an analysis of the epidemic curve in New York City, where the highest number of COVID-19 cases currently are.
Drawing on coronavirus data from Europe and Asia, Dr Gottlieb made an “optimistic” prediction that New York will reach the peak of new diagnoses in 1 or 2 weeks, followed by a week of deceleration and then a leveling off approximately another week later. The New York trajectory is similar to that of Spain and Italy, he said, and will likely follow a similar trend in the time from mitigation implementation to a slowdown in new cases.
Dr Gottlieb cautioned that although the number of new cases of COVID-19 infections will ease in the coming weeks, the number of hospitalizations and deaths will lag diagnoses, sometimes significantly. As data from China show, although the number of new cases peaked 6 weeks after Wuhan implemented its mitigation efforts, the number of new hospitalizations peaked 4 weeks later, and deaths continued to rise. The Chinese data showed an average of 9 to 12 days to hospitalization and an average time to death of 3 to 6 weeks.
Although no aggregated data are available for the United States, data from the United Kingdom showed shorter times to hospitalization and death than in China. Dr Gottlieb said he expects US data to follow the UK experience more closely, which means that the disease here may be more aggressive and briefer than in China, but because hospitalizations and deaths lag the peak in the epidemic, the healthcare system will continue to be overburdened, and hospitalizations and ICU admissions will increase for several weeks.
Thus, he said, it is important for policymakers and the public to understand that “just because you see a region declining in the number of new cases, the healthcare system is going to continue to be significantly pressed.”
Turning to what is happening in the rest of the country, Dr Gottlieb called it a “concerning situation.” Although the number of cases in the Pacific Northwest seems to be slowing, in many northern cities, including Philadelphia, Boston, and Detroit, the number of cases is accelerating, with new diagnoses doubling approximately every 3 to 4 days. However, he added, early mitigation efforts were followed more stringently in these regions and travel plummeted. As a result, he expects to see a leveling off of new cases in the coming weeks, even as they continue to rise in the short-term.
The situation is more troubling in areas outside of the Northeast and in some of the western states, because mitigation efforts did not occur, particularly in the Sun Belt states and in the Southeast.
“These regions look really concerning. We’ve been saying for weeks now that New Orleans looks really bad. I would put Florida in that camp as well, perhaps Georgia. And you have to be very concerned about Texas. These are big populated states that were late to mitigation and still haven’t implemented it with vigor…and have potential to have really large outbreaks,” Dr Gottlieb said.
These states are also undertesting, said Dr Gottlieb, with Texas testing only 0.17% of their population, placing it 45th of 50 states for testing per capita. He referred to the grim predictions in the government modeling delivered by Anthony S. Fauci, MD, and Deborah M. Birx, MD. These models forecast possible deaths in excess of 200,000. Although he concedes that such an outcome is possible, the modeling depends on conditions in the South and southeastern states.
Dr Gottlieb believes that Florida and Texas are poised to have very high rates of infection. “It’s going to be a difficult month,” he said.
Dr Gottlieb predicts reaching the peak of infections in early May, with the possibility of lifting some mitigation steps in June. It is possible that the virus will have a seasonal component and will follow the course of the H1N1 epidemic in 2009, he said, where it was quiescent in July and August and re-emerged in September.
The question is, said Dr Gottlieb, “will we have a different enough toolbox…that allows us to go back to some semblance of our normal lives” come September?
Dr Gottlieb is confident that there will be an effective disease surveillance system in place by Fall, but he noted that it will take a drug to effectively change the contours of the risk profile of this pathogen. He added that although we are still learning about the virus, the statistics have been consistent globally. China may have underreported the severity of COVID-19 cases, but “we have a pretty good handle” on the disease morbidity, he said, with approximately 80% of infected patients having moderate disease, 15% needing hospitalization, 3% needing intensive care, and 1% succumbing to the infection.
“This is a virus that wants to infect 40% of the population,” Dr Gottlieb concluded. However, “the notion that there is a vast pool of people who have been exposed and seroconverted is not true. This is a long way of saying, we’re not going to have herd immunity.”
Ted Okon, MBA, Executive Director, Community Oncology Alliance (COA)
Jeff Patton, MD, President, Tennessee Oncology
Lucio Gordan, MD, President, Florida Cancer Specialists
Up to 65% of cancer care is delivered via community cancer centers that are not part of a hospital or academic center. These centers are feeling the impact of COVID-19 as the pandemic reshapes the way these facilities provide care to patients.
Each of the panelists represents a community-based provider and discussed some of the measures they have taken to ensure that they can continue to deliver care to patients during these extraordinary challenges.
“We can shut down the country; but we can’t shut down cancer. Cancer keeps going,” said Mr Okon. The aim of COA is to keep community facilities open and treating patients. COA quickly mobilized to deliver information and resources, including a Listserv and a resource webpage, to community-based providers.
Mr Okon said that practices are seeing a 20% to 30% reduction in visits, and telehealth has been important. COA worked to promote the implementation of telehealth for its individual practices and held webinars that focused on practical solutions for providers. COA has also lobbied for insurers to stop prior authorizations and offered guidance to practices on how to apply for governmental grants through the CARES Act.
Dr Patton said that the priority of community oncology is to care for fragile and vulnerable populations. But, he added, Tennessee Oncology also wants to protect providers, who are the heroes. To protect patients and providers, Tennessee Oncology has implemented a series of measures meant to limit exposure to the new coronavirus, keep its clinics open, and deliver oncology care.
“Our primary focus is on our active treatment patients,” Dr Patton said, adding they have been able to maintain their curative and palliative patients and deliver therapy during this time. To do this, Tennessee Oncology has adopted Centers for Disease Control and Prevention guidelines, including risk-assessment protocols; enhanced sanitation practices; and tightened screening for visitors, patients, and practitioners.
Although new patient visits are down 30%, Dr Patton said, “Because we are able to deliver our primary service, we think that our practices will be able to survive.”
“We are bracing for impact,” said Dr Gordan. “We are trying to prepare staff as in wartime; to deliver the best care and best quality” to more than 75,000 new patients annually.
Since the beginning of the pandemic in early March, Florida Cancer Specialists has reduced its infusion volume by approximately 7%, patient visits are down by 30%, and there has been a drop in new patient visits of approximately 24%. Dr Gordan expects this reduction in new patients to have an impact on the practices in the weeks ahead, because new patients are the mainstay of the oncology business.
Maintaining patient and staff health is the priority, and their practices have adopted a range of policies and protocols to ensure that. To promote physical and mental well-being among staff, sick leave has been extended and behavioral health services are available to all.
To keep patients safe, they have put social distancing measures in their infusion suites, placing chairs 6 feet apart and consolidating other spaces. Telehealth is being used wherever possible, and they are delaying nonurgent appointments.
“We are one community and we will prevail, but we need to work together,” noted Dr Gordan.
Robert Carlson, MD, CEO, National Comprehensive Cancer Network (NCCN)
Pat Basu, MD, MBA, President & CEO, Cancer Treatment Centers of America
Christian Downs, MHA, JD, Executive Director, Association of Community Cancer Centers
According to the NCCN, an alliance of 30 leading academic cancer centers in the United States, the data suggest that although patients with cancer are not more susceptible to infection from the new coronavirus than other people, they do have much worse outcomes. “Prevention is thus the key for oncology patients,” Dr Carlson said.
“COVID-19 changed cancer care almost overnight,” he said. The care delivery centers in the NCCN are together taking an aggressive approach to screening for the virus and are sharing approaches and best practices. Comprehensive evaluation of patients and visitors to the cancer centers includes temperature monitoring, symptom screening, contact screening, and triage to an evaluation unit. Some facilities are not allowing patients to have accompanying visitors and are requiring masks for everyone entering treatment centers.
The NCCN centers have also implemented changes in the care delivery paradigm, including delaying appointments, using telehealth for follow-up and surveillance appointments, prioritization of care, and the separation of coronavirus-positive patients to specialized units.
The workforce and workplace are also having to adapt to the new circumstances, said Dr Carlson. In addition to shortages of equipment, the workforce is being depleted by infection or quarantine, and the physical and emotional stress of the pandemic is taking a toll.
Dr Basu said that providers are seeing a tremendous amount of confusion by patients about the messaging during this crisis. As a result, providers are fielding hundreds and thousands of phone calls on a broad range of questions about what patients have seen in the news.
Another area of concern is the shortage of provider protective equipment (PPE); consequently, we’re seeing price gouging for PPE that is so crucial to the protection of healthcare providers. Dr Basu said that in some cases, there has been an 800% markup on critical items, such as N95 masks.
Finally, he said that some large community oncology centers are engaged in debates as they confront new situations, including how to handle patients who have crossed state lines for care and whether to treat patients from neighboring hot spots.
“This is really a time for providers to band together to show the nation how we take care of patients,” he said.
Mr Downs discussed the concerns of smaller healthcare systems and hospitals, and the impact the virus is having on their operations.
Smaller systems have different needs and challenges than larger systems, he said. Many small healthcare systems are already overextended and are having difficulty maintaining operating margins and staying fully staffed. Some are struggling with new challenges in understanding telehealth or adapting to new testing procedures and care coordination across departments.
Many systems have large populations of patients who require social services and patients experiencing difficulties with insurance coverage or clinical matters, all of which further strain limited resources. This will become a crisis if the predictions in the acceleration of cases bear out.
“We want to keep the big picture in view,” Mr Downs said.
Lillie Shockney, RN, BS, MAS, HON-ONN-CG, Founder, Academy of Oncology Nurse & Patient Navigators (AONN+)
Brenda Nevidjon, MSN, RN, FAAN, CEO, Oncology Nursing Society (ONS)
Oncology nurses and nurse navigators are positioned on the front lines of cancer care, playing an integral role in patients’ battles against cancer. Ms Shockney and Ms Nevidjon discussed the rapidly changing world that oncology nurses are facing because of COVID-19.
“We’ve got this time crunch now for being able to provide the patient education and the psychosocial support, and the majority of that is being done through telehealth, not with the patient face to face,” Ms Shockney said.
She explained that oncology nurse navigators have a unique position in supporting patients with cancer, including identifying and addressing barriers to care. Such barriers have only increased during the COVID-19 pandemic, especially in relation to financial barriers and delays in care.
“We’re relying more on our nonclinical patient navigators,” Ms Shockney noted, for connecting patients with financial resources and for supportive services.
COVID-19 has delayed at least 2 important aspects of cancer care, she said. Approximately 80% of cancer screenings have been halted amid the crisis, as has community outreach. The crisis has also called on navigators to adapt their roles.
According to Ms Shockney, oncology nurse navigators are performing many of their former duties as an oncology nurse to fill the increasing need for nurses. “But the navigation doesn’t go away, so they’re wearing both hats at this particular point in time,” she said.
According to Ms Nevidjon, this is true for all oncology nursing, with oncology nurses now deployed based on nursing needs within health systems, which are not limited to oncology.
“I think the strength of what has happened among the oncology nursing community is that we know that first we’re a nurse, and then we’re an oncology nurse,” Ms Nevidjon said. “One of the things we’re concerned about as an association is the potential of a nurse being floated one day to a COVID-19 treatment unit and the next back to the oncology inpatient unit.”
According to Ms Shockney, there is a “crisis method of management” in cancer care, which applies specifically to patients with advanced cancers. “Time won’t stand still for them,” she said. With many patients too immunocompromised to receive their next treatment, referrals to hospice and palliative care are happening sooner, which, ironically, is something AONN+ advocates for.
“The patients will live longer, we know that from research, and they will have better quality of life as one of the outcomes of this ironic change,” Ms Shockney added.
Another concern is continuing cancer treatments for patients with COVID-19, Ms Nevidjon said. The current recommendation is to try to move their appointments to the end of the day and to conduct a deep cleaning overnight. The full recommendations are updated regularly on the ONS website.
Patricia J. Goldsmith, CEO, CancerCare
Daniel Klein, President and CEO, Patient Access Network (PAN) Foundation
Patient advocacy organizations regularly field and fulfill requests for assistance from patients with a serious illness, such as cancer. In the face of COVID-19, such requests have increased exponentially. Ms Goldsmith and Mr Klein outlined their organizations’ efforts to meet patients’ needs.
“Many patients with cancer, chronic disease, or rare disease were already seriously challenged, and the COVID-19 pandemic has just added to that challenge,” said Mr Klein.
Ms Goldsmith agreed, saying that CancerCare has garnered recognition for its efforts after funding from Bristol-Myers Squibb and Merck allowed for the creation of a model disaster relief program in partnership with 18 organizations. Even with that foresight, however, CancerCare had not prepared for a pandemic, she said.
“To give you some sense of the magnitude of what the organization is experiencing, as of March 30, we received 6009 calls from individuals looking for guidance, practical assistance, and financial assistance,” Ms Goldsmith noted. “There is a lot of desperation out there,…I think even higher than the levels we experienced during 9/11.”
In response, CancerCare mobilized the 3 pillars of its organization: psychosocial support, education, and financial assistance. Along with creating a resource webpage on COVID-19 for patients and caregivers, CancerCare hosted a virtual workshop on the virus for people with cancer, she said. The organization also created a fund for patients with cancer undergoing treatment who have COVID-19. The fund provides $300 grants to offset living costs. The CancerCare Copayment Assistance Foundation has been inundated with requests.
At the end of March, CancerCare partnered with the LUNGevity Foundation to provide $500 grants to patients receiving active treatment for lung cancer. In addition, CancerCare launched a program to help patients cover pet expenses during treatment, so far disbursing more than $41,600.
The PAN Foundation has also been working hard to meet patients’ needs via the PAN COVID-19 Assistance Fund, which provides $300 grants to patients diagnosed with or who self-quarantine because of the novel coronavirus, Mr Klein said.
The goal of these programs is “to add additional support to patients who are already struggling with out-of-pocket costs and with access and affordability issues,” he said.
More than 85% of the PAN Foundation’s grant recipients are >300% below the federal poverty level and many are Medicare beneficiaries, so the organization is focused on copayment assistance, noting that House Speaker Nancy Pelosi has proposed “putting a moratorium on out-of-pocket costs during the pandemic.”
“Coupled now with the pandemic, the amount of financial burden that is hitting vulnerable patients is tremendous,” Mr Klein said.
Julie Gerberding, MD, Chief Patient Officer, Communications, Global Policy, and Population Health, Merck
Brian Morrissey, VP, Strategic Customer Group Oncology, Pfizer
Eric Dozier, VP, Oncology North America, Lilly Oncology
The healthcare supply channel is dependent on drug manufacturers and their innovation and production. Representing 3 of the major biopharmaceutical companies, Dr Gerberding, Mr Morrissey, and Mr Dozier discussed the drug manufacturers’ response to the COVID-19 pandemic, announcing a recent collaboration in the fight against the novel coronavirus.
Through the “first care responders” program, these 3 companies are encouraging their employee clinicians to volunteer on the front lines in hospitals, where their clinical skills can help to care for patients during this crisis. The companies will pay the salaries of their employees who donate time to the effort.
“There is no silver lining to coronavirus, but in some sense, this is a real opportunity for the biopharmaceutical industry to step up to the plate and be the very best we can be,” said Dr Gerberding.
According to Dr Gerberding, the first priorities at Merck are ensuring the safety of its employees, sustaining the supply of medicines and vaccines, and taking care of patients enrolled in clinical trials.
Dr Gerberding noted the unprecedented response to the pandemic crisis, with clinical trials already off the ground, and that there has never been a more rapid mobilization to find treatments and vaccines. She added that Merck’s contribution is not limited to scientific interventions, and that the company has donated items such as 500,000 N95 masks to hard-hit areas in New York and New Jersey.
Mr Morrissey said that Pfizer has not seen a disruption in the supply of medicines they manufacture, and in fact, the company has stepped up its shipping. In addition, Pfizer has undertaken initiatives to relieve pressure on the supply system.
Through its “5 Promises,” Pfizer is also committed to encouraging scientific innovation in the field and vows to help smaller companies with promising therapies or vaccines scale up production to meet demand and get the medications to as many patients as possible.
Mr Dozier said that Lilly also has an effort underway to prevent undue stress on the system. Lilly has paused most of its clinical trials programs, with the exception of some pivotal trials, and pulled its sales force from the field early on.
Mr Dozier said that the goal at Lilly Oncology is to make sure that patients have access to their medicines and that they are affordable.
“The focus at Lilly has been on finding solutions and bringing them to bear quickly,” said Mr Dozier.