COVID, Cancer, and the Need for Rapid Regulatory Relief

Robert Graboyes interviews Cancer Treatment Centers of America’s CEO, Pat Basu, MD, MBA

By Robert Graboyes

One of the most stressful moments in American history is upon us, particularly for one population: cancer patients. Their COVID-19 story is worth telling. It’s a story of missed opportunities and unnecessary suffering, of regulation standing in the way of relief, of opportunities waiting to be taken.

Pat Basu, president and chief executive officer of Cancer Treatment Centers of America Global

The other day, I spoke with Pat Basu about the plight of cancer patients at this time. Pat is president and chief executive officer of Cancer Treatment Centers of America Global, which includes Cancer Treatment Centers of America (CTCA). He also is a renaissance man—a longtime innovator in the fields of medicine, business, and public policy. And though we’ve seldom been in the same room together, I consider him a friend, thanks to years of conversation and brainstorming via electronic communications.

Pat earned a B.S. in mechanical engineering from the University of Illinois, and an M.D. and M.B.A. from the University of Chicago. He was on the faculty at Stanford University, a White House Fellow, a venture capitalist, healthcare executive, and telemedicine pioneer.

Pat and I discussed how the current crisis is impacting cancer patients and so much more in a brief conversation. This interview is an expansion of our chat.

The following transcript has been lightly edited for clarity.

Basu: Bob, it is always great to connect, even if it is during these challenging times for the nation and the world.

Graboyes: Let’s start with a problem getting a lot of attention nationwide—the critical shortage of surgical face masks. You mentioned a problem with your hospitals getting shipments of N95 mask face masks. Could you elaborate?

Basu: I would be happy to elaborate. We are the only national oncology network in the United States, and caring for cancer patients remains our singular focus. As COVID-19 escalated around the world, in order to secure protection for our patients and clinicians, we increased our orders for N95 masks or equivalents (this is a certain standard for protecting against airborne pathogens). After an exhaustive search of suppliers with available product, we were set to receive an order of 30,000 N95 equivalent masks. However, just a few days before arrival, we learned in a letter from the Food and Drug Administration (FDA) to the industry that, due to the increase in several counterfeit versions, some masks were no longer going to be approved or cleared by the FDA, and we had to rush an order stop. The timing couldn’t have been worse, because only a few days earlier we had re-confirmed on the Centers for Disease Control and Prevention (CDC) website that we could use the mask as an alternative. The letter created more confusion because it directed the health care industry and manufacturers to the CDC link, where the masks were then listed as acceptable equivalents. Due to this, we were forced to scramble to procure masks at a 600 percent markup (at $3.40 per mask, while they were previously approximately $0.49 per mask). Even worse, the procurement process turned into something reminiscent of a 1930s market, where price and availability were fluctuating vastly by the hour.

Graboyes: How could we loosen that logjam?

Mercatus senior research fellow Robert Graboyes

Basu: There are several solutions to consider. First, consistency around what level of mask is required for this crisis. In addition to the FDA-CDC contradiction above, there are all sorts of government bodies making recommendations on when and what type of mask is appropriate, ranging from multiple re-uses of masks to various equivalents. Second, if a national standard is going to be mandated, some method of making them available is needed. The Strategic National Stockpile could be bolstered to meet this requirement and reduce its inventory expense. In addition, some sort of de facto set of US manufacturing capabilities could produce them in very short order. Finally, in the year 2020, we should invest in scaling 3D manufacturing capabilities to quickly produce these at low cost.

Graboyes: Now, let’s get to the meat of our discussion. COVID-19 and the virtual shutdown of American daily life poses a mortal risk to your patients. Why is that?

Basu: This is a crisis for cancer patients, who for years have been told that early, consistent and complete therapy is essential to battling this deadly disease. They are receiving mixed messages and experiencing disruptions in treatment and access during the COVID-19 crisis. As the second leading cause of death, taking nearly ten million lives annually worldwide and more than 600,000 in the United States alone, cancer is also a large public health crisis and, if care continues to be disrupted, one that will only get worse. At an individual level, it is causing a great deal of confusion, stress, and frustration. In most cases, the postponement or cancellation of a therapy is out of the patient’s control. An administrator, politician, or provider is telling them they don’t have room or that their care has been deemed non-essential. I want to be clear: not one of these individuals is intending to be difficult, they just might be out of beds, operating rooms, or clinician capacity from COVID-19. Finally, in the remainder of cases where it is the patient’s choice, they are choosing not to go to their general hospital because they are fearful it might be flooded with COVID-19 cases.

Graboyes: How serious are these delays in treatment for cancer patients—or those simply due for routine cancer screenings?

Basu: These are serious delays. I’ve spoken to patients who have had delays in cancer surgery, radiation therapy, and infusion of their chemotherapy. In many cases, the patients were told the delay might be a couple of weeks. However, there is no guarantee of that. In reality, the reasons cited for delay will only get worse over the course of a couple of weeks, and there will be major delays. Most estimates predict this virus being a source of respiratory illness for at least the next six months. Although cases of patients with active cancer are certainly the most urgent, eventually, patients undergoing screening and surveillance will be vastly delayed as well. As a system we can’t have it both ways. We can’t tell people to get treated consistently, get screened regularly, and get diagnosed early–except for right now when we’re telling you to wait six months.

Graboyes: In terms of deaths, what kind of numbers are we talking about?

Basu: Globally, approximately 26,000 patients will die of cancer every single day. In the United States alone, nearly 5,000 patients will get a new diagnosis of cancer every single day. In severity, scope and scale, cancer is one of the most horrific diseases to impact humankind. We can’t afford to turn our backs on cancer patients or their battle for a single moment.

Graboyes: A few days ago, I read that COVID-19 presents a terrible dilemma for therapists working with patients with obsessive-compulsive disorder. One of the common strategies of OCD therapy, I read, is persuading patients to avoid repetitive hand-washing. Now, those same therapists have to reverse years of advice and ask their patients to wash their hands frequently, potentially undermining years of therapeutic advice. You mentioned that there are similar problems with respect to cancer patients. What would those be?

Basu: Cancer is a physical disease that also creates distress and can affect emotional well-being. One of the reasons for our excellent outcomes (as measured in survival rate and satisfaction) is our approach to whole-person care. In addition to our staff who help with the emotional and social determinants of health, we encourage friends, family and visitors to come with our patients for their care and our patients to keep up as much of their social contact as possible. Both of those must be modified in this current time. However, we are doing all we can to continue providing integrative care, including behavioral health, through different mediums, such as telephone support and educational materials.

Graboyes: I was particularly intrigued by your idea of shifting cancer patients from large general hospitals to smaller specialty hospitals, such as the ones you run. Could you explain the logic of such an arrangement?

Basu: Imagine a simplistic model where there are 200 beds in an area (100 cancer specific beds at our hospital and 100 beds at a general hospital) and of the 100 cancer patients in the region, normally 50 will be seen at our hospital, and 50 will be seen at the general hospital. But now, the general hospital needs every one of those beds, and then some, to care for COVID-19 patients. Furthermore, if those hospital clinicians are getting exposed to COVID-19, it is difficult to imagine their immune-deficient cancer patients not being at risk--so they’ve closed all their beds to any cancer patients. Now, similarly for us, we aren’t set up to be a COVID-19 center nor would we be able to. But even if we’re seeing 50 of our own patients, we can temporarily take care of those 50 patients from the other hospital. We can collaborate on records, continuity of care, and follow up, and return those patients to their providers when appropriate.

Graboyes: You also mentioned that non-cancer patients—such as those destined for neurological surgery—could be moved into cancer hospitals. Could you please explain that logic, as well?

Basu: The proposal above is tailor-made for the current situation. But with some ingenuity we could try to help the situation even more. Even though our clinicians exclusively focus on cancer care, we have the advanced facilities, devices, and other staff to take care of other complex cases (i.e. cardiac, orthopedic surgery). In this case, if we collaborated, we could partner with other providers to credential their physicians (e.g. a cardiac surgeon, orthopedic surgeon) to care for their urgent cases at our hospital and have their patients recover in our beds. So, in the model above, let’s imagine we had 50 cancer patients and 25 cancer patients from another provider, we could help them out by creating opportunities to see 25 more of another type of case if their doctors came over to do those cases.

Graboyes: I’m a medical layman, but those sound like great ideas to me. What’s stopping you from making such arrangements?

Basu: There are several contributing factors that cut across government and industry, including anti-kickback statues that limit the ability of hospitals to cooperate freely to send patients to the right places during a crisis, particularly where the transfer of care is temporary. There are arcane state border issues and insurance barriers that prevent access. In the model above if some of the patients above aren’t in network and that restriction isn’t lifted during the crisis, they may have another barrier to getting lifesaving care. Primitive telehealth restrictions inhibit our ability to deliver safe care during an emergency and ease the burden on the communities we serve. In addition, you have restrictions or certificate-of-need regulations (CONs) around specialty hospitals, which in their current state provide a much better environment at the macro and patient level to decompress the general, acute care facilities and treat patients in a safer environment away from COVID epicenters.

Graboyes: What are some public policy solutions that could improve the lives of your hospitals’ patients and the work of your providers?

Basu: I believe there are several solutions to this, including easing the transfer of care from acute, general hospitals to cancer-specific hospitals through better communication, better coordination, and better policies. Insurers should lessen their insistence on in/out of network distinctions with little or no reimbursement for patients who could otherwise be seen. Governments at all levels need to relieve telehealth restrictions: despite the Centers for Medicare and Medicaid Services (CMS) reimbursing this to some extent, state medical boards have continued to maintain a protectionist, guild mentality requiring a state license to do so—this prevents access and raises costs. In their effort to contain the spread, various elected officials implementing travel bans and recommending cancer patients stay home have inadvertently blocked access to necessary care for many who need it. This can be solved through more advanced discussion around what is emergent, additional thought behind the language of guidelines (with special attention to the use of ‘emergency’), and maintaining an emphasis on individual doctor-patient risk-benefit assessment.

Graboyes: When we first met, you were a telehealth entrepreneur. Could you elaborate on the role telemedicine can play in helping your cancer patients—particularly with those fearful of contracting Covid-19?

Basu: Absolutely. Cancer patients have an increased risk of not only contracting the COVID-19 infection but developing more severe symptoms. There are several reasons for this, including cancer’s impact on the body, the type of cancer diagnosed and certain treatments. The role telehealth plays to ensure provider-patient connectivity, care continuity, and protection of patients and clinical teams is critical. CTCA has greatly enhanced its telehealth capabilities across service lines and subspecialties, recently scheduling more than 1,000 telehealth appointments to provide patient support. This is incredibly helpful in the near-term, but cancer patients still need fast access to the surgical, radiation and chemotherapies that are critical to saving their lives.