More than 20% of cancer-related claims for next-generation sequencing (NGS) from Medicare beneficiaries were denied between 2016 and 2021. Findings from a cohort study published in JAMA Network Open suggested that there is continued uncertainty about the boundaries of coverage for NGS, even with the implementation of a Medicare national coverage determination (NCD) in 2018.
Denial rates were varied by testing type and site, and the rates of denials increased over time, in line with the increase in NGS testing claims.
“We expected that there would be more certainty around how NGS services are covered with the NCD in 2018, but what we found is that there is a lot of uncertainty still, and potentially even growing uncertainty,” said lead study author So-Yeon Kang, PhD, MBA, Assistant Professor in the Department of Health Management and Policy at the Georgetown University School of Health. “Additional efforts to reduce uncertainty around NGS coverage and raise awareness of potential financial consequences are necessary.”
Study Methods and Results
The Centers for Medicare & Medicaid Services (CMS) implemented an NCD for NGS in March 2018, which initially focused on somatic testing and was limited to patients with recurrent, relapsed, refractory, metastatic, or advanced cancer. In January 2020, the NCD was amended and expanded to include germline testing for individuals with a risk for or diagnosis of breast or ovarian cancer.
Uncertainty about coverage standards and associated reimbursement challenges have challenged the expansion of NGS testing.
The study authors analyzed a 20% random sample of Medicare claims data for cancer-related NGS testing from between January 1, 2016, and December 31, 2021. Claim denials were based on payment and denial data. Denial rates were assessed before the NCD, after the initial NCD, and after the NCD was amended in January 2020.
The study included 29,919 total cancer-related NGS claims among 24,443 Medicare beneficiaries. There were 1,912 claims in 2016, which increased to 9,177 in 2021. A total of 23.3% of the claims in the sample were denied. The denial rate was 16.8% before the NCD, 20.3% after the NCD was initially implemented, and 27.4% after the NCD was amended.
“Providers may have been slow to modify how they use advanced genetic testing for cancer in response to the Medicare coverage decision,” said Dr. Kang. “We’ve seen evidence of limited responsiveness to national coverage determinations in other contexts.”
Claims were more likely to be denied if they were performed at an independent laboratory (odds ratio [OR] = 2.76; 95% confidence interval [CI] = 2.58–2.95; P < .001) or at other nonhospital sites (OR = 2.55; 95% CI = 2.12–3.07; P < .001). Additionally, they were more likely to be denied if the testing claim was for at least 50 genes for solid tumors (OR = 1.32; 95% CI = 1.23–1.43; P < .001).
The potential for a claim to be denied was higher both after the NCD was initiated and amended compared with before the NCD was put into place.
“As more advanced NGS testing replaces lower cost, lower value diagnostic alternatives, we need to know how much this will impact the outcomes of cancer care, which is a key question,” Dr. Kang concluded.
Going forward, Dr. Kang is investigating the financial impact that value-based precision medicine has had.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
