This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
The COVID-19 pandemic has been catastrophic to health care in the US.
Much has been written about the impact on hospitals and on the health care professionals enduring horrific stress to support the acutely ill. These providers are heroes, and we are all indebted to them. But less attention has been paid to the indirect effects of the pandemic on health care, particularly the care delivered to those with chronic medical illnesses.
What has happened to cancer patients? Although we will be able to trace the course of the acute infectious elements of COVID, which play out over weeks and perhaps a couple of months, the impact on cancer care will likely play out over many months and even years.
These effects are important to address from several perspectives, including those of the patient, the provider, the payers, and the research enterprise. Potential lasting effects, both good and bad, need to be considered. What does cancer care look like now? And how will it be changed forever?
Absent screening and neglected symptoms
There is never a good time to get cancer. COVID has made it infinitely more complicated.
Depending on where the patient is on the cancer journey, the disruption has been either inconvenient or even life-threatening. Let’s start at the beginning. Although statistics are not readily available, people aren’t getting mammograms or colonoscopies. Cancer surgeries are also way down, even though one could debate as to whether these surgeries are really elective.
There is little doubt that patients are experiencing a delay in cancer diagnosis; to what degree this will impact outcomes is unclear.
We do know that when patients don’t undergo cancer screening, they present with later-stage cancers and are more likely to die of their disease. At this time, how long it will take to get past these delays in screening is also unclear.
Given the backlog, even if you want to get screened, the line may extend for quite some time. Skipping screening this year could be a really bad decision. In addition to patients forgoing or delaying screening during the pandemic, symptoms that are often a harbinger of cancer that would normally precipitate a visit to the doctor have been tolerated or ignored because of anxiety to leave home and a desire to comply with social distancing.
What will happen to the woman who feels a lump in her breast and decides the risk of seeking medical attention is too great? The natural consequence of patients presenting with neglected symptoms of cancer is an unfavorable outcome.
Active treatment, immunocompromise, and increased risk
Patients undergoing active treatment encounter an entirely different set of challenges. Almost all patients undergoing active therapy, and especially those receiving chemotherapy, are taught that they are immunosuppressed and at risk of infection.
This is often linked to the white count and periods of neutropenia and its associated risk. But the truth is that the immunosuppression in cancer patients is multi-factorial, being both treatment-related as well as disease-related. This is particularly true in hematological malignancies.
What is clear is that the very limited data that exists does suggest that this immunosuppression is potentially life-threatening when it comes to COVID, with a much higher risk of infection, a complicated clinical course and even death.
Patients who need therapy face a Hobson’s choice. Should they leave their relatively safe shelters, be exposed to other immunosuppressed patients in their doctor’s office, be exposed to the health care providers who are likewise multiply exposed, and face serious consequences? Will delaying therapy risk a poor cancer outcome?
Most authorities have favored moving ahead cautiously when the therapy is potentially curative or might result in significant clinical benefit. How often patients (or their providers) are delaying is not clear. Anecdotally, clinics have been maintaining their treatment volumes.
But there are certainly some therapies that are, for the most part, on hold, such as bone marrow transplant. And most bone marrow transplants are not elective procedures.
Support and management
Patients who have completed therapy or are receiving therapy (like hormonal therapy for breast cancer) that do not require close follow-up face yet another set of challenges.
Patients generally like seeing their oncologists at these visits. These visits are important for many reasons. They provide follow-up of the underlying malignancy as well as the ongoing or late toxicities of treatment. But they also provide an opportunity to reinforce health maintenance, like smoking cessation. And they reinforce an important personal bond between the care team and the patient.
They are reassuring and life-affirming. If there are problems, they offer an opportunity to intervene.
These visits have been the first to be eliminated during COVID. To some extent, they have been replaced by telehealth visits (more on telehealth later). But you cannot do a thorough breast exam or palpate lymph nodes on telehealth. You cannot check a CBC. And you cannot hold someone’s hand.
It will literally be impossible to measure the impact that cancelling these visits will have.
Perhaps the impact on cancer survival will be negligible, but it will matter to patients. Some practices have been under the illusion that they would just bring these patients in when this is all over, but if the pandemic lasts a lot longer, they just won’t have the capacity.
These direct consequences are easy to articulate. There are many others. The impact on mental health, especially depression, which is always a risk in cancer patients will be profound. There are likely to be issues with substance abuse, including opioids and alcohol.
People will lose employer-sponsored health insurance as a consequence of losing their jobs, making access to care even more of a problem. The consequences of financial toxicity will be magnified.
There is little doubt that the COVID pandemic will increase mortality for cancer patients, even among those never infected with the virus.
Taking care of cancer patients is a hard job. COVID has made it much harder.
Many of the clinical challenges patients experience are also experienced by the oncologist. Making decisions about whom to treat and whom to delay are incredibly difficult. The impact of these decisions on patient outcomes is totally unknown and may well remain unknown for some time.
But for oncologists, particularly community oncologists, practical matters regarding keeping their practices safe and solvent are especially challenging.
Altering clinic PPE rations
A safe environment for patients and the care team has been taken as a given. Even complex issues like safe chemotherapy handling are executed in an almost matter-of-fact way by most practices.
But COVID is different. The risk of infecting patients and staff has mandated adoption of infection control procedures completely foreign to most practices.
From telephone screening of patients immediately prior to their visits, through triage at clinic entrances, to immediate quarantine and testing of suspected cases, to providing PPE/safe distancing/strict handwashing practices to safeguard staff, there is no such thing as business as usual.
Practices have consolidated sites of service. Visitors are excluded from the office. CDC guidance changes frequently and staffing, masking, and contact protocols are constantly changing. Rescheduling clinic patients and evolving staff working from home models cause recurring challenges clinically and administratively.
Testing availability is limited, and testing efficacy is suboptimal.
Practices are burdened with insufficient supplies of masks and other PPE, and the normal supply chain has been altered when production or competing need present obstacles to standard operating procedures.
The oncology office of today is nothing like the oncology office of yesterday. And the staff is feeling the stress, both of the risk of infection as well as the risk of losing their jobs.
For many patients, this has meant not coming to the office at all. To provide clinical services, practices have turned to telemedicine as an alternative.
Contrary to popular perception, this has not been a smooth transition. To start with, most physicians (especially older ones) are not particularly tech savvy. The mechanics of a telemedicine visit are different.
And patients are equally challenged. Data suggests as many as 40% of cancer patients do not have a smart phone or access to a computer at home. And there are clear limitations to a telehealth visit, including the inability to have a meaningful physical exam or check routine labs.
Patients do value interacting with their doctors, but whether a telehealth follow-up visit is as valuable as a clinic visit is purely speculative.
Medicare has helped a lot. Reimbursement for telehealth is at parity with office visits and HIPAA restrictions have been lessened. This provides significant and much needed revenue to practices. Telehealth is a life preserver in these challenging times, but its future after COVID remains uncertain.
To be certain, after COVID, the vetting of the various telemedicine solutions (which has not taken place in the typical fashion due to the crisis) will occur, as well as an analysis of the both the clinical as well as economic implications of managing specific patient subsets with this technology.
Foot traffic in most oncology offices is decreased substantially. Although there is regional variation, practices in hot spots have seen a 60 percent drop in visits.
Treatment visits are down as well, but to a lesser extent. New patient referrals have plummeted, which means patient volume will remain low even after shelter in place restrictions are lifted. Medical oncology is the subspecialty of medicine with the highest ratio of overhead to revenue, largely as a consequence of the cost of chemotherapy.
But labor costs in oncology practices are very high due to the number of oncology nurses as well as other support staff needed to support every oncologist. Jobs are in jeopardy.
Oncologists have access to at least three sources of revenue from the government. First, they can apply for the small business loans that provide payroll support. These loans are forgiven if staff is retained. They provide about ten weeks of payroll support.
Many oncology practices have applied for these loans. But the application process has been onerous. Further, as of this writing, the initial appropriation has been depleted.
Second, the practices are eligible for a grant via the Cares Act. These grants provide an award based on last year’s Medicare billing. There are conditions the practice must attest to in order to qualify, including agreeing to take care of COVID patients.
Unfortunately, it is almost impossible to figure out how much money each practice is entitled to. CMS has provided a rough calculation, but it is impossible to figure out how CMS arrived at the number.
Finally, practices can request accelerated and advance payments from Medicare. This allows practices to request prepayment for services they expect to provide over the next three months; any invoices submitted for services actually rendered will be reconciled against the prepayment.
If this sounds confusing, it is. Practices, frankly, have enough on their plates without trying to manage this ledger, although it is possible that hospitals might be interested.
Hospitals face even greater challenges.
The demands on hospitals to transform their existing organizations into massive emergency rooms and ICUs has been challenging and expensive. COVID patients, especially Medicare patients, consume a lot of health care resources that are not adequately reimbursed.
And the most lucrative patients, especially those undergoing elective surgical procedures, have disappeared.
The staff that serviced these elective surgical patients are expensive to employ, and they are idle. The balance sheet is not pretty. Hospitals are hemorrhaging money.
The Cares Act gets hospitals money from Medicare. But even with this grant, hospitals have been forced to furlough staff, or significantly reduce their compensation in the non-ER and non-ICU space. Given the incredible stress that hospital staff is already experiencing, this adds insult to injury.
The point of this long discourse is that practices are financially strapped and have significant staff commitments. The government is genuinely trying to help, but this money in no way can offset loss of revenue from care administered to commercial health plan patients.
Like many other businesses in America, they are endangered.
The payer perspective
The effect of the COVID pandemic on payers has been difficult to evaluate.
Patients hospitalized with severe COVID-related illness are very expensive. Medicare is shielded from these costs, because they pay the DRG that is billed (which does not even come close to the cost of care, a burden borne by the hospitals).
Some commercial payers pay hospitals on a DRG basis, but many more pay a percent of billed charges. As a consequence, each COVID patient represents a million-dollar expenditure. However, for any given payer, the number of these patients is relatively small.
But health plans are protected by stop-loss insurance. And these costs are more than offset by the dramatically reduced numbers of patients undergoing elective procedures.
Recently, some payers have released first-quarter earnings, and this offset has preserved their profit margin.
Not everything is rosy. Employees are losing employer-sponsored health insurance, and as a consequence, the payer is losing the premium dollars. Some payers have extended the grace period for premium payments for 30-60 days, but some employers will go out of business and others won’t be able to afford the health care premiums for their workers.
It is to be expected that as the country recovers, the demand for these elective procedures will increase, but it won’t happen overnight. There is precedent. During the recession in 2008, health care expenditures dropped substantially, and the upward trend resumed as soon as the financial crisis resolved.
But it took time.
More importantly, from an oncology perspective, the inertia that had built up behind alternative payment models in oncology has been halted. Although CMMI has not publicly announced a delay in the transition from the Oncology Care Model to the Oncology Care First Model, it is impossible to imagine them moving forward.
In fact, it seems obvious that they will need to somehow adjust the two-sided risk requirement of the Oncology Care Model due to the potentially catastrophic impact of the cost of a COVID patient attributed to any practice in the OCM. Commercial payers, likewise, have been forced to put programs on the back burner.
Practices are simply too engaged in responding to COVID to consider the effort required to succeed.
Finally, discussions regarding trying to control the costs of prescription drugs have gone totally silent.
In fact, the national sentiment that an anti-viral or a vaccine, which almost certainly be the product of intense R&D activity in the life sciences sector makes it difficult to envision a time when resurrecting this debate will be politically possible.
The research perspective
COVID has been devastating to clinical trials.
This disruption has included a delay in opening new trials, a suspension of new accruals for ongoing trials, and challenges with continuing therapies on patients in the middle of the trial.
There is also a question about diversion of funds earmarked for cancer R&D to COVID-related projects.
Why is this a problem? Most oncologists believe that in many cases, enrollment on a clinical trial offers the best treatment option; this is particularly so if the trial is examining an exciting novel therapy in a disease in which conventional treatment options are poor.
Further, trials (particularly registration trials) are the path to access post regulatory action. In many cases, these novel therapies represent a significant improvement over standard of care. And if the pipeline is shut off at the source (due to reallocation of resources), the outcome cannot be good, though it may be impossible to measure.
The biggest problem, however, will be faced by those drugs that have ongoing registration trials. How will we be able to analyze efficacy and toxicity when doses are skipped and evaluations are missed? How will the FDA mange this aberration in trial performance?
Again, the indirect damage of interrupting what has been a tremendously successful research enterprise on the downstream beneficiaries, i.e. cancer patients, cannot be good
Surely, the vast majority of cancer patients and cancer doctors would love to wake up tomorrow and find COVID was just a bad dream. We dare say most oncologists would jump at the chance to have things the way they used to be. Are there any silver linings in these clouds?
There are at least two:
We will rethink routine care.
Although we may pretend that oncology is scientific and evidence-based, much of what we do is more related to habit.
For example, how often is it appropriate to see a woman receiving adjuvant hormonal therapy for early-stage breast cancer? How often should an oncologist see a woman receiving trastuzumab for a year? How about a CML patient on imatinib?
The answer to these questions is that there is no answer. Practice is arbitrary and often transactional. And there is some evidence, particularly for patients with serious cancer receiving therapy, these interactions do not really happen when patients need them, because of toxicity or symptom burden.
The emergence of telehealth as well as remote patient monitoring may change this. Prior to COVID, there was some interest in moving these forward, with new billing codes and an emergence of technology.
But COVID has accelerated this. There is tremendous potential to use these technologies to dramatically change how we engage our patients. It is easy to see how this might improve care. This will not replace the office visit; it will supplement it.
There will still be a need for the physical exam and the lab monitoring and the personal touch. How far this might go is a little tough to predict.
Recently, CMS allowed home infusion of intravenous cancer therapies. Of course, the rule is complicated and full of restrictions. It requires an accredited home care agency. It requires tele-monitoring during the infusion. It requires a complicated financial relationship between the physician and the home care agency providing the infusion.
The overwhelming majority of infusion therapies for cancer require direct physician supervision. Adverse events, like allergy or clinical decompensation, occur frequently in an infusion room and require physician intervention.
But the patient receiving the trastuzumab for a year, or one receiving denosumab for bone health, or leuprolide for prostate cancer could easily be managed at home. They key to the realization of this remote monitoring and therapy is the payers.
What will CMS do after COVID?
Can we get commercial payers on the same page?
While one can argue that telehealth cannot replace an in-person visit, it will find its niche. Telemedicine can offer acute care, follow-up, advanced care planning, survivorship, genetic screening, supportive care, and palliative care.
If supportive telehealth policies continue after the pandemic, telemedicine can serve patients by providing more comprehensive services without patients having to travel. It makes comprehensive cancer care easier.
Many have opined that clinical trials need an overhaul and COVID has proven that. Clinical trials do not meet the patient where they are. They are designed for the convenience of the physician investigator and the study sponsor.
It is insensitive to patient challenges. A lot of this can be done at home, and it should be.
Again, telehealth can perform as the primary modality for many study visits. The ability to simplify the process of participating in a trial will help accrual markedly and speed completion of trials. COVID should lead to intense reflection on the potential benefits of clinical trial evolution using telehealth.
COVID has been devastating to health care.
Cancer care has been collateral damage. Irrespective of the public health wisdom of opening America, we need to be able to resume caring appropriately for cancer patients. We need to build on the enhanced patient engagement we have seen during COVID.
The oncology community has very high expectations for the quality of care delivered. Until we emerge from this dark time, we need to be nimble and evolve to serve our most vulnerable patient population.