Ethical Allocation of Proton Therapy and the Insurance Review Process

Abstract

Purpose

The purpose of this study was to delineate a scoring system to maximize the ethical allocation of proton beam therapy (PBT) and determine what factors are associated with receipt of PBT, including the role of specific insurance providers.

Methods and Materials

Our scoring system was developed in collaboration with a multidisciplinary panel of experts. Patients submitted for PBT consideration were assigned a score by committee at a weekly peer-reviewed session at a time when our center was operating at capacity. Univariate analysis and multivariable analysis of initial and final insurance response were performed.

Results

One hundred ninety-seven patients were prospectively reviewed. Ninety-three percent of patients with Medicaid coverage, 88% of patients with Medicare, and 78% of patients with private insurance were ultimately approved for PBT. Median time to final insurance response was 12 days (interquartile range, 9-18 days) for patients who were ultimately denied PBT coverage. Having primary provider C (odds ratio [OR], 14; 95% confidence interval [CI], 1.20-1.96; P = .033) or third party providers A (OR, 4.22; 95% CI, 1.71-10.9; P = .002) or B (OR, 5.28; 95% CI, 1.56-17.2; P = .006) was significantly associated with final insurance denial for PBT on univariate analysis. Total score (OR, 0.79; 95% CI, 0.67-0.90; P = .002) and having coverage through third party provider A (OR, 24.2; 95% CI, 9.51-68.9; P < .001) were associated with final insurance response on multivariable analysis.

Conclusions

Our scoring system was significantly associated with receipt of proton beam therapy. Certain insurance providers are less likely to approve PBT for patients, all else being equal. Such a scoring system could be implemented effectively at other PBT facilities, and additional work is needed in ensuring patients with the most to gain from PBT will be approved by their insurance providers.

Introduction

Since the first proton beam therapy (PBT) facility came online in 1954, over 130,000 patients have been treated using this technology.¹ Research over the past 65 years has shown improved outcomes for specific populations of patients treated with PBT versus the more ubiquitous photon-based radiation therapy (XRT). This improvement in patient-related outcomes is due largely to the improved spatial dose distribution afforded by PBT and its ability to spare normal adjacent tissues while delivering effective doses of radiation to target volumes.² This normal-tissue sparing effect of PBT is due primarily to the phenomenon known as the Bragg peak, wherein accelerated protons are able to enter a volume and deposit energy with virtually no exit dose.² Well-accepted indications for PBT include treatment for a host of malignancies in pediatric patients as well as some forms of adult malignancies (eg, skull-base chordoma and chondrosarcoma).3, 4, 5 However, there remains heated debate among experts in the field of radiation oncology regarding the appropriateness of PBT, especially for patients in instances where the benefit of PBT over XRT has yet to be definitively elucidated.¹

This debate has manifested itself in the health care marketplace, with insurance companies who have often been reluctant to authorize PBT for beneficiaries, citing a lack of evidence of superior outcomes and the often-higher costs associated with PBT over XRT. This is despite evidence that PBT can be cost-effective when used appropriately, given the lower rate of acute and long-term toxicities that are associated with PBT.⁶ Not only has PBT been associated with a reduction in toxicity compared with traditional XRT, the improved precision associated with PBT has also cleared the way for investigation into dose escalation, with the goal of improving local control in aggressive tumors such as chordoma.⁷

If a patient is initially denied insurance approval for PBT, they can either appeal the decision, pay for PBT out-of-pocket, pursue alternative treatment, or decline treatment altogether. For the percentage of patients who choose to appeal their denial of PBT coverage, their treatment is often delayed significantly while they await the results of their appeal(s). As the vast majority of patients seeking PBT insurance approval are doing so for the definitive treatment of a malignancy, this delay in treatment can result in increased morbidity and mortality for many patients.⁸ The difficulty in deciding which patients are appropriate for PBT, and which should receive insurance authorization, is further exacerbated by the limited number of active proton facilities relative to photon facilities. Additionally, many providers face a dilemma regarding prioritization of patients in the setting of centers operating at full capacity while attempting to meet the needs of geographically large catchment areas.

The clinical ethical principles of beneficence and nonmaleficence require that providers should submit for insurance approval only those patients for whom benefit from PBT can be reasonably expected. However, providers must weigh any potential benefit derived from PBT against potential harms caused by treatment delay due to the insurance approval process. The latter of these 2 ethical judgments is often more difficult and subjective, as it relies on a provider’s ability to make predictions about the behaviors of insurance companies. Ideally, there would be an objective system or set of criteria to aid providers in identifying which patients would derive benefit from PBT, while also minimizing delays in care secondary to insurance denials and appeals. Other centers have attempted to address such dilemmas by creating novel scoring systems and correlating them with the likelihood of their patients receiving PBT.^9,10 However, the application and generalizability of such previously described systems remain difficult to discern.

At our institution, we operate a single-vault proton facility at full capacity, 16 hours daily. To address the problems of PBT appropriateness, insurance authorization, and treatment-slot prioritization within our facility, we have developed a novel scoring system with the goal of ethically allocating PBT to patients with the greatest need and appropriateness. Concurrently, we have prospectively collected data regarding patients who were submitted for insurance authorization for PBT and characteristics associated with receiving PBT. The primary goal of this study was to both delineate our methodology in developing a novel scoring system designed to maximize the ethical allocation of PBT and determine whether this scoring system could be used as a tool to predict a patient’s likelihood of ultimately receiving PBT. Secondary goals of this study were to determine specific patient characteristics that have the greatest effect on patients’ ability to get insurance authorization for PBT and whether factors other than physician- determined clinical need, including insurance provider, would influence how an individual patient was treated.