Insurance Coverage of Novel Therapies – Where Should We Draw the Line?

Insurance Coverage of Novel Therapies – Where Should We Draw the Line?

A highly publicized UHC denial of care led to more questions than answers.

By now many have read the ProPublica expose on how UnitedHealthcare (UHC) did nearly everything possible to avoid paying for the treatment of an insured patient with ulcerative colitis. If you have not read it, you can find the article here.

Let me start by saying that the behavior of the UHC employees, whether condoned by management or not, was inexcusable, and everyone hopes this leads to change. Many of us have heard from commercial insurers that their staffs, including their medical directors, are in no way incentivized to deny care. And this may be true, but what happened with this patient suggests that there may be more devious factors in play.    

But while the behavior of UHC is abhorrent, the case itself does raise an interesting issue. This patient was quite unique, with a disease that was refractory to all usual treatment regimens. He was clearly receiving the best of care, seeing a world-renowned gastroenterologist who works at what is often referred to as the best health system in the world: the Mayo Clinic. As the article describes, he was receiving two medications that are not normally used together, both at doses that are significantly higher than regularly prescribed. And while the article notes that “there was evidence that the treatment plan for McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe,” they provided no references. A recent literature review notes that “the overwhelming majority of the literature consists of case reports and case series.”   

In fact, the patient’s gastroenterologist was quoted as stating that “my treatment of Chris was not clinically inappropriate — as was shown by Chris’s positive outcome.” As is commonly noted, the plural of anecdote is not data. In other words, the response of one person, or even a few patients, does not prove that a regimen being used is both effective and safe. It certainly may be, but a proper clinical trial is required to be performed to test that hypothesis.

This case contrasts with a recent denial by Premera Blue Cross that went viral on Twitter and was covered by Medscape News; it was about approval for Keytruda, an immunotherapy for breast cancer. In this case, the treatment was supported by National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ACSO) guidelines for this patient. Clearly, the insurance company was wrong for denying coverage, and according to the article, the vice president of medical management reversed the denial when provided the references.

Even if guidelines and studies are not available, as often happens with cancer therapy, there are compassionate care programs that allow patients to access experimental therapies. Drug companies can, with Food and Drug Administration (FDA) approval, allow patients to receive medications that are not yet FDA-approved outside of a clinical trial. Most insurers and Medicare also provide coverage for cancer treatments that are not only FDA-approved, but also supported by clinical compendia or clinical trials published in peer-reviewed journals. And many pharmaceutical companies offer patient assistance programs for their medications when the patient has no coverage or inadequate coverage.

So, the lingering goal with this case is to define the obligation of insurance companies to pay for therapies that have not been properly studied. Certainly, in this situation, it may be difficult to find enough patients with such refractory disease in order to test the treatment in a trial. Should that play a factor? Should there be a definition for rare manifestations of diseases that forces insurers to pay for any treatment proposed by a licensed physician? Should it be based on the qualifications of the treating physician? While I will not address the controversies that manifested during the COVID-19 pandemic, it certainly illustrates the complexities of patients’ rights to access to treatments, and who is obligated to pay for that.

Let me make it clear: I am not a fan of insurance companies. I have written extensively about their tactics in avoiding paying for medically necessary care to maximize their profits. I honestly do not think there is a perfect solution to the issue of healthcare and am confident that no matter what system is tried, there will always be people who figure out how to cheat the system for their own benefit. For some diseases, the literature is clear on what care is beneficial and what care is not, as we see with use of implanted cardiac defibrillators. But if we have learned anything, it is that what may be perceived as beneficial may later prove to either provide no benefit or even cause harm, as with the use of Xigris for septic shock or tight control of diabetes in the frail elderly.

Do I have an answer here? Certainly not. This patient had the benefit of being able to see one of the most renowned gastroenterologists in the world for his treatment, so the decision to try this regimen would appear to have support – and probably obligated the insurance company to pay for it. But would this apply to a patient in another town who is being cared for by a physician who has never treated a patient with such severe disease, but thinks an untested regimen is worth trying? What if that treatment resulted in a catastrophic outcome? Who is responsible? I certainly know that the answer is not that only those who can generate enough social media attention should get their care covered.


Ronald Hirsch, MD, FACP, CHCQM, CHRI

Ronald Hirsch, MD, is vice president of the Regulations and Education Group at R1 Physician Advisory Services. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute-care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the Advisory Board of the American College of Physician Advisors, a member of the American Case Management Association, and a Fellow of the American College of Physicians. Dr. Hirsch is a member of the RACmonitor editorial board and is regular panelist on Monitor Mondays. The opinions expressed are those of the author and do not necessarily reflect the views, policies, or opinions of R1 RCM, Inc. or R1 Physician Advisory Services (R1 PAS).

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