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The Biden-Harris Administration recently re-launched the Cancer Moonshot, setting ambitious goals to cut the rate of cancer deaths by half over the next quarter century and to improve the clinical experience for individuals diagnosed with cancer. An important component of this far-reaching initiative is a strong recommitment to reduce the well-established disparities in the prevention, diagnosis and treatment of cancer. The timing of this announcement is noteworthy, as a spark is sorely needed to jumpstart the restoration of the millions of cancer screenings and treatments that were missed or postponed due to the COVID-19 pandemic.
This version of the Moonshot pays careful attention to cancer screening and early detection, calling for solutions that support patients through the entire cancer screening process until a diagnosis of cancer is made (or not). It also urges the development of innovative screening tools, particularly those that expand the number of cancers detected, as nearly 50 percent of cancer diagnoses and deaths occur in cancers that currently do not have a recommended screening test.
Accordingly, in the Moonshot call for action, Federal agencies led by the National Cancer Institute, will develop a focused program to expeditiously study and evaluate multi-cancer detection tests (MCEDs) that are designed to detect cancers at earlier stages when they may be more effectively treated. While the potential upside for MCEDs to improve patient-centered outcomes is considerable, the available evidence is insufficient to establish meaningful clinical benefits.
Manufacturers of currently available MCEDs are now conducting trials to develop the evidence needed to fully assess the benefits and harms and therefore, to support applications for regulators and payer. Recognizing that, until that threshold is met, many commercial insurers and the Medicare program may not cover these tests, though some may engage in pilot programs. And without payer coverage, the use of currently available MCED screening tests – and their potential health benefits – will likely be limited to more affluent individuals who can afford to pay out of pocket.
A March 2022 Health Affairs article by Patricia A. Deverka and colleagues articulates the significant evidentiary requirements for manufacturers and the complex challenges faced by payers as they deliberate a coverage determination for these novel precision techniques that screen for multiple cancers simultaneously. They must balance the many years it will take for trials enrolling tens of thousands of randomly assigned patients to demonstrate a net survival benefit of adding MCEDs to standard screening against the potential harms of delaying their use – for example, lives lost due to cancer. In the interim, the potential use of intermediate endpoints to assess tests’ net survival benefit should be explored to guide decision-making.
Deverka et al. raised a very important and often underappreciated point. Even when an initial cancer screening test, such as a MCED test, is fully covered, patients may face high out-of-pocket expenses for necessary follow-up diagnostic services. Constrained access to clinically indicated follow-up testing is not unique to MCEDs. It applies to all cancer screening, since an abnormal result from an initial screen such as a mammogram or low dose CT scan typically leads to a recommended sequence of clinical interventions to determine whether a definitive diagnosis of cancer can be established. Because certain demographic patient groups at high risk for cancer may have difficulty paying substantial out of pocket costs for essential care, generous payer coverage for the follow-up diagnostic testing is needed to avoid exacerbating disparities in cancer screening and early cancer diagnoses.
Access to MCEDs provides additional opportunities to enhance equity. The convenience associated with a single blood test to screen for multiple cancers may lead to a reduction in disparities because of the proposed ability to detect more aggressive tumors that disproportionately affect minority patients. Moreover, although the impact of the availability of MCEDs on recommended cancer screening rates is unknown, there is potential that the increased convenience of a MCED blood test can lead to a “teachable moment” in which eligible individuals, not yet up to date on recommended screenings, increase their use.
Conversely, as Deverka et al point out, it is also possible that overall, recommended screening rates might decline, as some people may feel that a MCED is ‘enough’. This could happen despite manufacturers’ strong emphasis that MCEDs are to be used in conjunction with, and not as a substitute for, recommended screenings. Researchers and policy makers must closely follow this interaction between MCED availability and recommended screening rates as the use of MCEDs evolves in various patient groups.
In addition to advocating for the expansion of the armamentarium of cancer screening tools, this latest iteration of the Moonshot explicitly calls for interventions that increase uptake of currently recommended cancer screenings. There is robust evidence that screening average risk populations for breast, cervical, colorectal and lung cancer have led to impressive net clinical benefits. To increase uptake and help ensure equitable access, policy makers should consider strategies such as supporting more convenient screening options (for example, at-home stool based tests for colorectal cancer) and increasing access, especially for underserved populations.
Despite outreach and other efforts, the full potential of evidence-based screening programs in terms of reduced cancer morbidity and mortality has not been achieved; this is largely due to suboptimal adherence. The Patient Protection and Affordable Care Act (ACA) requires group and individual health insurance plans to provide coverage without patient cost-sharing for the initial screening test for breast, cervical, colorectal and lung cancer. This provision, designed and implemented to prevent financial barriers from deterring patients from seeking necessary and evidence-based preventive care, does not require that insurance plans cover the necessary follow up after the initial test to establish the presence or absence of a diagnosis of cancer. Recent updates from the United States Preventive Services Task Force (USPSTF) for colorectal and lung cancer screening have since expanded eligible populations, paying specific consideration to women and Black and Brown communities.
A 2021 review examining the impact of the ACA preventive care mandate reported that a majority of published studies showed increases in use of fully covered services following the elimination of cost sharing; results varied widely depending on the specific services. Importantly, studies that included socioeconomic status reported more substantial increases in utilization of preventive services in financially vulnerable patients as compared to those with higher incomes, suggesting that the policy reduced disparities in the delivery of preventive care.
These enhanced coverage requirements have proven to be extremely impactful. A 2022 Office of the Assistant Secretary for Planning and Evaluation report updated estimates of the number of Americans benefiting from these provisions: 150 million with private insurance, 61 million Medicare beneficiaries, and approximately 20 million Medicaid adult expansion enrollees. The report also describes trends in utilization of preventive services, and related clinical outcomes.
Still, as the Cancer Moonshot insists, we must go further, making additional investments in the infrastructure necessary to better implement the USPSTF screening recommendations and enhance equity.
For example, recent studies of patients needing follow-up care after initial (no cost) screening for breast, cervical, colorectal and lung cancer reported significant out-of-pocket costs borne by average risk individuals with an abnormal initial screening test (Exhibit 1). Failure to complete a screening process could allow cancer to progress, leading to worse patient outcomes and higher medical costs. The presence of financial barriers to fully complete a screening/diagnostic process undermines the primary goal of cancer screening, which is to detect those individuals who could benefit from early detection and receipt of effective treatment.
Source: Author’s analysis of recent research including: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8371567/ ; https://journals.lww.com/greenjournal/Fulltext/2022/01000/Out_of_Pocket_Costs_forColposcopy_Among.16.aspx; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786794 ; https://pubmed.ncbi.nlm.nih.gov/34600897/
The 2021 update to the USPSTF colorectal cancer screening recommendation explicitly recognized that “to achieve the benefits of screening, abnormal results from stool-based tests, CT colonography, and flexible sigmoidoscopy should be followed up with colonoscopy”. This statement provided input to a 2022 guidance released by the Biden-Harris Administration as part of the Affordable Care Act Implementation Frequently Asked Questions Part 51.
This new federal rule removes cost sharing for a colonoscopy following a positive non-invasive colorectal cancer screening test. By eliminating out of pocket costs, this policy will help hundreds of thousands of people avoid the dilemma of having to decide if they can afford to follow up on their initial positive colorectal screening test.
This new regulation – aligned completely with the goals of the Center Moonshot – is a victory for patients. Currently limited only to those with commercial insurance, it provides a template for a similar policy for Medicare beneficiaries who are not included in the recent colorectal cancer guidance. A 2021 study reported that over three quarters of Medicare claims for follow-up colonoscopy after a stool-based test had associated non-trivial amounts of cost sharing, averaging from $99 to $231 depending on the original screening test used. The out-of-pocket costs were even higher when polyps were removed during the procedure, suggesting increased colorectal cancer risk.
The successful creation of a national regulation that removes financial barriers for the entire colorectal cancer screening process warrants that similar policies be quickly put into place for individuals who need follow up care after an abnormal initial screening test for breast, cervical and lung cancer. And because these malignancies disproportionally impact women and people who identify as Black, Brown Indigenous and Hispanic, the benefits of increased screening uptake and completion would help achieve the Moonshot aim of reducing cancer disparities.
The latest liftoff of the Cancer Moonshot aspires to develop trailblazing diagnostic technologies and therapies. While substantial time and resources are devoted to these reach-for-the-stars advances, the federal government and other payers should also rapidly take ‘one small step’ to remove barriers that deter patients from completing the cancer screening processes already within reach.
This feasible, low-cost policy has potential to a be a ‘giant leap’ for health equity. After all, the available evidence suggests that reducing consumer out of pocket costs can increase cancer screening uptake, enhance equity and ultimately reduce cancer morbidity and mortality, especially for patient groups that underutilize these potentially life-saving interventions.
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