Past CMS and FDA Head Discusses Challenges in U.S. Health-Care Policy and Possible Solutions

A Conversation With Mark McClellan, MD, PhD

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Mark McClellan, MD, PhD

Mark McClellan, MD, PhD

As evidenced at this year’s ASCO20 Virtual Scientific Program, oncology science, technology, and clinical practice are evolving at a rapid pace, bringing new challenges to the efficient and ethical practice of cancer care at all levels. To shed light on some of the large-scale public health and policy issues that affect the oncology community, The ASCO Post spoke with Mark McClellan, MD, PhD, Director of the Robert J. Margolis Center for Health Policy at Duke University. Over the course of Dr. McClellan’s career in public health, he has served as U.S. Food and Drug Administration (FDA) Commissioner under President George W. Bush and subsequently as Administrator for the Centers for Medicare & Medicaid Services (CMS).

Current Role

Please tell the readers about your current work.

I’m Director of the Robert J. Margolis Center for Health Policy at Duke University, and our mission is to develop better policies and solutions to address health and health care on a national level. In doing this, we bring together a variety of disciplines. I’m a physician, and even though a lot of our faculty are also from the medical realm, we try to take a broader approach to policy that includes economics, business, ethics, public policy, and a range of other fields. One of our research teams is based in Washington, DC, because we want to focus on practical approaches that are implementable and can make a difference, not just research that makes for good publications, important as that is.

Making Value-Based Choices

You’ve written about incentivizing value in health care. Is value-based care feasible in the fee-for-service payment model that predominates in the United States?

First, I need to emphasize how important it is to pay for lifesaving cancer treatments and not let some of the rising costs of new drugs, for instance, confuse us about their value. In fact, some of my earlier work looking at the interface of economics and medicine was about the absolute value derived from high-quality cancer care. So, as a society, we do need to pay more for better treatments, but there are some very real challenges in a fee-for-service payment system. For instance, payments may not be accurately aligned with the best clinical needs of the patient.

One of the goals of developing payment models that are not based on volume is so oncologists can put the resources where they make the most difference. If that means using the more expensive drug or therapy, then we should not hesitate to pay for the clinical choice that provides the best outcomes. I’d like to emphasize that this is not about incentivizing waste, but about making value-based choices.

Most oncologists across the country are working hard to deliver the best care possible for their patients, operating in a very challenging environment. I’ve seen many examples in practices that we have worked with, in which 24/7 teleconference help lines are put in place, and members of the oncology team have access to a patient’s full medical information. Valuable communications can obviate the need for an emergency room visit because the crisis can be dealt with at home or via an extended office visit. That’s a better and less expensive option for the patient and the health-care system, but one that is not properly reimbursed in our traditional payment model.

“One of the goals of developing payments models that are not based on volume is so oncologists can put the resources where they make the most difference.”
— Mark McClellan, MD, PhD

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This is but one example of payment problems we need to solve. To that end, there are efforts underway at CMS to create reimbursement models that align the needs of patients and providers. During these discussions, it’s important to note that the oncology community is on board with value-based care, but we also need to understand that many hard-working oncologists are facing economic challenges. There is no easy one-size-fits-all solution, but I’m hopeful we’re moving in a smart direction.

Drug Costs

A study presented at the 2018 ASCO Annual Meeting found that a month’s worth of chemotherapy for metastatic colorectal cancer cost twice as much per patient in the United States as it did in Canada, and survival was no better on the U.S. side of the border.1 Is there a way to find middle ground on pricing?

There are a lot of proposals intended to create stronger price negotiations for payers, whereby they can refuse to cover a particular treatment if they feel it is overpriced according to its clinical value. When we compare prices between the United States and Canada, it’s important to note that much of that discussion might be driven out of frustration. But saying we want the same prices as Canada isn’t a way to bring about stronger negotiations. For example, Medicare is required to cover every oncology drug in Part B for the average price the manufacturer charges. Perhaps a smarter way is to let Medicare negotiate the price according to a drug’s value, as determined by evidence-based medicine.

What concerns me about the current debate is that we are not really focusing on price negotiations according to value. Assessing the value of cancer drugs across patient populations is not easy, but given our growing databases and technologies, we should be able to move toward common ground between cost and value-based reimbursement.

Coverage Decisions

In deciding whether to cover an item or service, CMS must determine whether that it is “reasonable and necessary” for the treatment of Medicare beneficiaries. Please shed some light on that process.

Since the 1960s, CMS has been covering services and procedures that it deems reasonable and necessary for the treatment of an illness, which was a pretty narrow and outdated model about what can actually influence patient outcomes. So, we needed to add prescription drug coverage, which wasn’t initiated until 2006—way behind the time it should have been included. Since then, legislative actions have tried to add preventive measures, such as colon and breast cancer screening, to the definition of reasonable and necessary services covered by CMS.

One limitation is in the area of new personalized medicine, simply because the definition of reasonable and necessary is increasingly personalized. The challenge in implementing a reasonable and necessary coverage definition in a Medicare fee-for-service payment program is in getting the necessary details properly aligned. This is one of the reasons why we should consider a value-based payment approach, such as an oncology care model or other payment reform model. The increasingly complex and personalized treatments in cancer care challenge the traditional coverage model, so again, determining value needs a specialized approach, one that I believe we are moving toward.

Obesity in America

Obesity is arguably the nation’s greatest challenge in public health care. The National Cancer Institute has identified at least a dozen obesity-related cancers, yet there seems to be a lack of urgency in addressing this problem. Please share your thoughts on this issue.

Along with many other serious health problems, the association between obesity and various cancer morbidities is well documented, which not only burdens at-risk individuals but also our health-care system. Unfortunately, there is no silver-bullet answer to this public health crisis. There are some regulatory measures and messaging that help, but this is a problem with deep root causes.

We know that behaviors around diet and exercise are developed in childhood, are long-lasting, and are difficult to mediate. Much of this also has to do with socioeconomic challenges that go beyond messaging about eating more salads and power walking to people who are working two jobs merely to pay the rent.

That said, we are not going to remedy this issue by putting money into the downstream consequences of obesity. We see an example of that in cancer, where we are constantly moving away from simply treating the sequalae of the disease to instead focus on early detection, molecular identification, and treatment at earlier stages. There are an increasing number of health-care programs like food prescription services that make it easier for low-income patients and their families to access the fresh fruits and vegetables they need to ensure they are eating balanced, healthy diets.

We could also keep health-care costs down and redirect those resources into innovative initiatives to tackle this issue. The obesity problem in America evolved over generations in a changing society, and it’s going to take years of concerted efforts to reverse that trajectory.

Impact of the COVID-19 Pandemic

What are your thoughts on the state of our health-care system during the current COVID-19 pandemic.

In a fee-for-service payment model, physicians across the nation are being financially challenged in a way we’ve not seen. One good thing in this very difficult time has been the rise and use of telemedicine, which, even in oncology, has cut costs and improved care in certain settings. For instance, in Pennsylvania, a program for moving cancer drug administration into the home along with a growing number of home-managed services has been developed.

The restrictions imposed by the COVID-19 pandemic will ease and eventually end, but it’s important to use these circumstances as a learning experience, one that has forced us to provide care with fewer resources under stressful situations. We can come out of this with a more streamlined and better delivery system. 

DISCLOSURE: Dr. McClellan has been employed by Brookings Institute, has served in a leadership position for Health Care Innovation and Value Initiative, and has served in a consulting or advisory role for Johnson & Johnson.


1. Yezefski T, Le D, Chen L, et al: Comparison of chemotherapy use, cost, and survival in patients with metastatic colorectal cancer in Western Washington and British Columbia. 2018 ASCO Annual Meeting. Abstract LBA3579. Presented June 3, 2018.