Prior authorization of medical procedures, services, and medications has been a standard requirement of health-care providers for decades. Rising health-care costs, specifically the escalating prices of cancer drug therapies, have led to a new focus by payers, providers, and policymakers on prior authorization. In providers’ view, prior authorization puts an additional cost and time burden on office staff. Providers also raise legitimate concerns of delays in care, with 33% of physicians reporting that prior authorization has led to serious adverse events, in a recent poll by the American Medical Association.1
S. Monica Soni, MD
Andrew A. Hertler, MD, FACP
In payers’ view, prior authorization serves three purposes: (1) It provides some assurance to providers that their claims for expensive medications will be paid; (2) it controls waste; and (3) it monitors quality of care. It is our view that providers do not so much object to these goals, but rather object to a process that has become overly onerous and intrusive, leading to practice inefficiencies. Here we explore where oncology prior authorization is important and valuable and where it must be meaningfully improved.
Overwhelming Complexity of Medical Oncology Can Lead to Mistakes
Medical oncology has changed enormously over the past 2 decades. Dramatic innovation fueled by tumor genomics, targeted therapies, and immuno-oncology has led to an acceleration in drug approvals and a massive increase in the complexity of clinical decision-making. Therapeutic choices are now often guided by individual tumor genomics, and despite the proliferation of clinical pathways, there are generally multiple allowable treatment options for a single patient. Among these possible regimens are many high-dollar drugs that received accelerated approval by the U.S. Food and Drug Administration (FDA) based on surrogate endpoints, but they have not delivered the hoped-for outcomes.2
Practicing oncologists not only have to keep up with an overwhelming volume of clinical literature, expanded indications, and new approvals, but also the subsequent real-world data that can lead to drug withdrawals. It is unsustainable and impractical; no single oncologist can keep up with such a volume of data. Despite best intentions, providers do make mistakes and/or may not offer the level of quality we should expect.
For years, ASCO’s Choosing Wisely campaign has advised against aggressive treatment of patients with solid tumors and a low performance status.3 In a review, in 2022, of data collected through our portal at New Century Health, we identified more than 600 patients with solid tumors who had an Eastern Cooperative Oncology Group (ECOG) low performance status of 3 or 4 and had cancer-directed therapy planned by their oncologist. More than half (51%) of the patients in question had advanced disease, suggesting the benefit of the treatment regimen may not have outweighed the risk of toxicity and other adverse outcomes. A significant portion of these patients had received immune checkpoint inhibitors.
We have found the perception that immune checkpoint inhibitors are better tolerated than traditional cytotoxic therapy has led to oncologists using them less discriminately. However, recent studies have shown that patients with an ECOG performance status of 2 or higher have a significantly poorer prognosis and response rate than their counterparts with an ECOG performance status of 0 or 1.4
Technically, all these patients met compendia criteria for their requested regimen. However, when a patient is labeled by an oncologist as being severely impaired or completely disabled, there is a high likelihood the treatment will not lead to the intended outcome of helping the patient live longer or better. It is our view that a discussion with another oncologist of the pros and cons of therapy before proceeding with treatment of such patients is warranted.
Delivering for Patients
The increase in FDA-approved drugs and expanded indications has also led to the misapplication of therapies outside the contexts in which they were originally studied. Parikh et al found that immune checkpoint inhibitor monotherapy was preferentially used in trial-ineligible patients with organ dysfunction or poor performance status.5 Unfortunately, there was no survival benefit in this population and a concern for harm. These real-world findings are concerning. Although extrapolation is common across medicine, in oncology, it can lead to increased patient toxicity and a distraction from essential end-of-life planning.
In 2022, our team reviewed and intervened upon more than 1,200 chemotherapy and immunotherapy requests that did not meet any compendia (National Comprehensive Cancer Network [NCCN], Truven Micromedex, Elsevier Clinical Pharmacology, American Hospital Formulary Service, or Lexi-Drugs). This means patients were offered an unproven treatment plan, possibly thinking it was the standard of care. Patients expect more of us, and we must deliver, despite the information overload.
Because of the fast and ever-changing pace of medical oncology, organizations such as NCCN and ASCO have stepped in to fill the gap, publishing and endorsing guidelines as clinical decision support. However, multiple studies have shown significant deviation from these guidelines in imaging, genomic testing, use of supportive drugs, and chemotherapy choices. There appears to be selective adoption of guidelines, with physicians arguing that their individual patient warrants divergence.6-8
Although autonomy and patient-centered care are absolutely to be defended, lack of standardization and differential approaches can lead to inequitable outcomes. A review of our data at New Century Health showed that practicing outside the recommended guidelines was common among oncologists. Examples include cases in which:
- Myeloid growth factors were requested as primary prophylaxis for regimens posing low risk for febrile neutropenia
- No disease progression monitoring was performed after four cycles of therapy
- Patients with active multiple myeloma did not receive a bone-modifying agent.
We acknowledge that our vantage point may miss clinically appropriate variance at the point of care, but at a population level, the “exception” can quickly wrongly turn into the norm.
In the same way that multidisciplinary tumor boards have become a well-accepted and standard part of patient care, there is a growing role for collaboration among stakeholders. Purchasers, health plans, and at-risk primary care groups are important voices who want to be sure that patients are living longer or better in exchange for the mind-boggling cost of cancer therapy. And when there remain profound racial and ethnic disparities in mortality, despite equal access and screening for certain cancers, our communities also deserve to know there is sufficient clinical oversight in the treatment phase. Although there has been skepticism of the value of utilization management, and it has justifiably been flagged as a contributor to burnout and administrative waste, our experience has shown that overused, misused, and unwarranted variation is not slowing.
‘Gold-Carding’: Squeezing the Balloon
The “gold-carding” legislation introduced in many states to help minimize the burdens associated with prior authorization in Medicare Advantage plans is a solution with the potential for unintended impacts, both in lower quality of care of enrollees as well as significantly increased cost for that care. The bill, H.R. 7995 Getting Over Lengthy Delays in Care as Required by Doctors Act of 2022, or GOLD CARD Act of 2022, would exempt physicians from Medicare Advantage plan prior authorization requirements if 90% of the physicians’ requests were approved in the preceding 12 months, which lends significant risk to the enrollee for the 10% or less of services that were denied for not meeting medical necessity. Proper denials prevent unnecessary services from being rendered, including services that could do harm.
The health-care industry should strive for the highest standards of quality. Consider the negative response if the 90% threshold were applied to other industries in which consumers rely heavily on experts. For example, airlines certainly do not pause or eliminate any quality checks regardless of the percentage of passing the check(s). To do so would be negligent and potentially have devastating consequences. Accepting a 10% denial rate is simply not the level of quality that should be acceptable for sensitive, high-risk services and procedures in health care.
Replacing prior authorization for such sensitive, high-risk services and procedures with a post-service/pre/post-pay oversight approach also falls well short of expectations to maintain oversight of efficacy, since the procedures have already been administered to the patient. Reviewing a service at the claim level simply does not prevent potential harm from being done.
Finally, although a post-service claim review is often used for fraud, waste, and abuse purposes, applying this to a gold-carding approach increases the amount of back-end review already done. Ultimately, this approach prolongs, and does not alleviate, the administrative burden of a provider needing to share clinical documentation by shifting from the front end of the process to the back end. There has already been qualitative feedback from providers in states such as Texas, where such an approach has gone live, that this back-end scrutiny is just as unwelcome and burdensome.
Additionally, although prior authorization may contribute to provider burden and administrative costs when applied extensively, limiting or eliminating prior authorization actually is more prone to increase costs. Recent research on drug utilization by the National Bureau of Economic Research found that to deter the same amount of care, an insurer can either charge a patient $227 per year in copayments or induce a provider to spend $22 in administrative costs.9 That $227 in copayments is also only a fraction of what it costs plans to reimburse the care. This shows that patients do need additional help price shopping, and the extra work that is put on providers via prior authorization is perhaps a significantly more cost-effective way to restrict costs compared with greater patient cost-sharing.
Proposing a Path Forward
Rather than eliminating utilization management, efforts should be made to streamline the processes, decreasing the provider burden. This can be accomplished through the development of interoperability between utilization management systems and electronic medical records with the use of Fast Healthcare Interoperability Resources (FHIR) Health Level Seven International® (FL7) standard for exchanging health-care information electronically. This, in conjunction with the use of natural language processing and artificial intelligence, holds promise of an almost passive prior authorization process in which providers are alerted to prior authorization decisions without even entering a portal and submitting a request.
When a request does not meet medical necessity, a peer-to-peer consultation should be conducted with another oncologist, with the goal of collaborating and determining the best treatment for that patient. Given that oncology treatment plans frequently include multiple drugs, the plan should be looked at in its entirety rather than by the individual drug, which is the common procedure in traditional prior authorization.
Finally, limiting or gold-carding prior authorization could be made available to practices willing to engage in alternative payment models in which they share a portion of the risk in partnership with the payer, who can provide decision support tools and analytic support. Much of the current antagonism between providers and payers would be eliminated if there were shared common goals, each desiring the success of the other. Such a path forward will necessitate all parties to cooperate on how to navigate the labyrinth of oncology care for the benefit of our shared patients.
DISCLOSURE: Dr. Soni and Dr. Hertler own stock in Evolent Health, the parent company of New Century Health. Dr. Soni also is an advisor for Waymark.
REFERENCES
1. American Medical Association: 2022 AMA prior authorization physician survey. Available at www.ama-assn.org/system/files/prior-authorization-survey.pdf. Accessed May 11, 2023.
2. Kim C, Prasad V: Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: An analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med 175:1992-1994, 2015.
3. ASCO: Choosing Wisely: Ten Things Physicians and Patients Should Question. Available at www.choosingwisely.org/wp-content/uploads/2015/02/ASCO-10things-list_2021-Update_2.pdf. Accessed May 11, 2023.
4. Krishnan M, Kasinath P, High R, et al: Impact performance status on response and survival among patients receiving checkpoint inhibitors for advanced solid tumors. JCO Oncol Pract 18:e175-e182, 2022.
5. Parikh RB, Min EJ, Wileyto EP, et al: Uptake and survival outcomes following immune checkpoint inhibitor therapy among trial-ineligible patients with advanced solid cancers. JAMA Oncol 7:1843-1850, 2021.
6. Bernicker EH, Xiao Y, Abraham A, et al: Adherence to National Comprehensive Cancer Network ALK testing guidelines for patients with advanced non-small cell lung cancer in U.S. community medical centers. Oncologist 26:e1050-e1057, 2021.
7. Gomez DR, Liao KP, Giordano S, et al: Adherence to national guidelines for antiemesis prophylaxis in patients undergoing chemotherapy for lung cancer. Cancer 119:1428-1436, 2012.
8. Shah LM, Carino TV, Hanger M, et al: Barriers to clinical practice guidelines adherence in the community oncology setting. 2011 ASCO Annual Meeting. Abstract e19687.
9. Brot-Goldberg ZC, Burn S, Layton T, et al: Rationing medicine through bureaucracy: Authorization restrictions in Medicare. National Bureau of Economic Research. Available at https://www.nber.org/papers/w30878. Accessed May 11, 2023.
Dr. Soni is Associate Chief Medical Officer of New Century Health in Los Angeles. Dr. Hertler is Chief Medical Officer at Evolent Health in Arlington, Virginia.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
