Insights From a Temporal Assessment of Increases in US Private Payer Coverage of Tumor Sequencing From 2015 to 2019

Trosman, Julia Rachel; Douglas, Michael P.; Liang, Su‐Ying; Weldon, Christine B.; Kurian, Allison W.; Kelley, Robin Kate; Phillips, Kathryn A.

doi:10.1016/j.jval.2020.01.018

Cited by 10 publications

(21 citation statements)

References 26 publications

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“…These findings are in line with a recent study of NGS coverage, which found that private payers implemented coverage policies at a higher pace after the Medicare NCD than before the NCD. 8 Although other studies have shown that private payers may not always follow a Medicare NCD, 13 payers have stated their intent to at least consider the contents for the Medicare NGS NCD, along with other criteria, for their own policy decisions. 20 The repeat testing component of the Medicare NCD was a point of concern with the implementation of the NCD.…”

Section: Discussionmentioning

confidence: 99%

Association Between Medicare's National Coverage Determination and Utilization of Next-Generation Sequencing

Sheinson¹,

Wong²,

Flores

et al. 2021

JCO Oncology Practice

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PURPOSE: In 2018, Medicare issued a national coverage determination (NCD) providing reimbursement for next-generation sequencing (NGS) tests for beneficiaries with advanced or metastatic cancer and no previous NGS testing. We examined the association between NCD implementation and NGS utilization trends in Medicare beneficiaries versus commercially insured patients. METHODS: This was a retrospective study of patients with advanced non–small-cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC), or advanced melanoma with a de novo or recurrent advanced diagnosis from January 1, 2011, through December 30, 2019, using a nationwide US electronic health record–derived deidentified database. Patients were classified by insurance and by advanced diagnosis date. NGS testing was assessed by receipt of first NGS test result ≤ 60 days of advanced diagnosis. Interrupted time series analysis assessed NGS utilization pre- and post-NCD effective date by insurance type. RESULTS: The utilization and repeat NGS testing analysis included 70,290 and 4,295 patients, respectively. Use of NGS rose from < 1% in 2011 to > 45% in Q4 2019 in aNSCLC while remaining < 20% in mBC and advanced melanoma. Among patients with aNSCLC, mCRC, or mBC, NGS testing increased post-NCD versus pre-NCD ( P < .05). There was no significant difference in trends pre- and post-NCD between Medicare beneficiaries and commercially insured patients in any tumor. Repeat NGS testing was similar before the NCD (Medicare v commercial: 24.8% v 28.5%). Post-NCD, fewer Medicare beneficiaries had repeat NGS testing (27.7% v 36.0%; P < .01). CONCLUSION: Trends in NGS utilization significantly changed post-NCD, although the magnitude of change was not significantly different by insurance type, indicating private insurers may also be incorporating NCD guidance. Implementation of the NCD may have limited use of repeat NGS testing in Medicare beneficiaries.

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Section: Discussionmentioning

confidence: 99%

Association Between Medicare's National Coverage Determination and Utilization of Next-Generation Sequencing

Sheinson¹,

Wong²,

Flores

et al. 2021

JCO Oncology Practice

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“…21 In fact, there was a significant surge in private payer policy coverage of genetic testing after the release of these guidelines. 22 Although some initial work, most commonly in the NSCLC space, has been conducted evaluating the impact of large-panel testing on treatment selection and outcomes, further research and the influence on outcomes is warranted. 16 , 23 , 24 …”

Section: Discussionmentioning

confidence: 99%

Novel Approach Using Administrative Claims to Evaluate Trends in Oncology Multigene Panel Testing for Patients Enrolled in Medicare Advantage Health Plans

Caplan

Wong²,

Ferries

et al. 2021

JCO Precision Oncology

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PURPOSE To develop an approach to identify and evaluate recent use of multigene panel testing over time. METHODS We conducted a retrospective database analysis using medical and pharmacy claims data. Medicare Advantage Prescription Drug Plan members diagnosed with select malignant solid tumors were identified. The pattern of somatic genetic testing for each patient was evaluated from January 2016 through December 2018. Tests were classified by the number of genes tested in the panel: < 50 (small or medium) and ≥ 50 (large). RESULTS An initial feasibility study using our novel approach for identifying panel tests resulted in 2.4 and 1.2 times more large and medium panels, respectively, identified compared with using procedure codes alone. A total of 121,675 eligible patients were identified, with 131,915 unique cancer cases. Overall, 5,457 (4.5%) patients received any panel test from 2016 to 2018. We found the number of tests performed each quarter increased from 238 in Q1 of 2016 to 755 in Q4 of 2018. The highest number of cases were genitourinary cancers; however, the highest proportion of cancer-related genetic testing was among patients with respiratory cancer. Across all tumor types, the proportion of large-panel tests performed as a function of all multigene panel tests increased from 20.7% of tests in Q1 of 2016 to 46.4% of tests in Q4 of 2018. The three cancer categories with the highest count of cancer-related panel tests, respiratory cancer, GI cancer, and female reproductive cancer, had a consistently greater proportion receiving a panel test at any point postindex. CONCLUSION Across a variety of cancers, use of somatic, large-panel cancer-related genetic testing, as a proportion of all somatic cancer-related genetic testing, increased from 2016 to 2018, although testing overall was low.

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“…Although the national BCBSA issued a technology assessment for "Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management," 18 BCBSA plans operate independently and each plan determines its own policies. 10,19 One complexity of private payer coverage is that payers structure their policies in many ways, ranging from policies focusing on very specific clinical conditions, genes, and brand-named tests to broad policies that cover many conditions and generic tests. This wide variation reflects the fact that private payers vary greatly in how they develop and structure their coverage policies.…”

Section: Discussionmentioning

confidence: 99%

“…13 However, our recent study of next-generation tumor sequencing coverage policies found that half of private payers were not providing coverage for such tests as of mid-2019. 19 Implications and Future Research 7 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for NSCLC indicate that ctDNA testing can be considered when a patient is medically unfit for invasive tissue sampling or if, after pathologic confirmation of an NSCLC diagnosis, there is insufficient material for molecular analysis. 23 In addition, studies that support clinical utility will likely result in greater consistency among coverage policies.…”

Section: Discussionmentioning

confidence: 99%

Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019

Douglas¹,

Gray

Phillips

2020

Journal of the National Comprehensive Cancer Network

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Background: Clinical adoption of the sequencing of circulating tumor DNA (ctDNA) for cancer has rapidly increased in recent years. This sequencing is used to select targeted therapy and monitor nonresponding or progressive tumors to identify mechanisms of therapeutic resistance. Our study objective was to review available coverage policies for cancer ctDNA–based testing panels to examine trends from 2015 to 2019. Methods: We analyzed publicly available private payer policies and Medicare national coverage determinations and local coverage determinations (LCDs) for ctDNA-based panel tests for cancer. We coded variables for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered. Descriptive analyses were performed. Results: We found that 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. Most private payer policy coverage was highly specific: 87% for non–small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests. There were 8 final, 2 draft, and 2 future effective final LCDs (February 3 and March 15, 2020) that covered non–FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies to cover pan-cancer use. Conclusions: Coverage of ctDNA-based panel testing for cancer indications increased from 2015 to 2019. The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage. We found that Medicare coverage policies are evolving to pan-cancer uses, signifying a significant shift in coverage frameworks. Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.

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Insights From a Temporal Assessment of Increases in US Private Payer Coverage of Tumor Sequencing From 2015 to 2019

Cited by 10 publications

References 26 publications

Association Between Medicare's National Coverage Determination and Utilization of Next-Generation Sequencing

Association Between Medicare's National Coverage Determination and Utilization of Next-Generation Sequencing

Novel Approach Using Administrative Claims to Evaluate Trends in Oncology Multigene Panel Testing for Patients Enrolled in Medicare Advantage Health Plans

Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019

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