{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T18:09:21Z","timestamp":1790878161701,"version":"4.1.0"},"reference-count":28,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n The Centers for Medicare &amp;amp; Medicaid Services implemented a National Coverage Determination (NCD) for genetic testing using next-generation sequencing (NGS) in March 2018 and amended it in January 2020. Little is known about how often NGS insurance claims are denied and what factors are associated with these denials.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To examine the prevalence of and factors associated with claim denials for NGS testing among Medicare enrollees.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This cohort study used a 20% random sample of Medicare claims data from January 1, 2016, to December 31, 2021. Statistical analysis took place from June to October 2024.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Claim denials were measured based on payment and denial data. Multivariable logistic regression models were estimated with patient and claim characteristics, including testing type, testing site, and time period indicators reflecting the presence and scope of the NCD: no NCD (period 1), first NCD (period 2), and amended NCD (period 3).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The study sample included 29\u202f919 cancer-related NGS claims among 24\u202f443 unique Medicare beneficiaries (51.8% males; 44.7% aged &amp;gt;75 years). The number of cancer-related NGS testing claims increased from 1912 in 2016 to 9177 in 2021. Claim denial occurred among 23.3% of the NGS claims in the sample. The claim denial rate was 16.8% before the NCD, 20.3% after the implementation of the NCD in 2018, and 27.4% after the amended NCD in 2020. Claims for NGS testing were more likely to be denied if they were performed in independent laboratories (odds ratio [OR], 2.76 [95% CI, 2.58-2.95];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) or other nonhospital sites (OR, 2.55 [95% CI, 2.12-3.07];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) vs a hospital or if they were for 50 or more genes vs 50 or fewer genes for solid tumors (OR, 1.32 [95% CI, 1.23-1.43];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The likelihood of a claim denial was higher in both time periods after the original 2018 NCD compared with before the NCD (period 2: OR, 1.23 [95% CI, 1.10-1.36];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; period 3: OR, 1.64 [95% CI, 1.49-1.80];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The claim denial likelihood for period 3 was significantly higher than period 2 (OR, 1.34 [95% CI, 1.24-1.44];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this cohort study of cancer-related NGS testing claims among Medicare enrollees, denial rates varied by testing type and testing site and increased over time. The findings suggest the continued existence of uncertainty regarding coverage for NGS, despite the NCD. Policy approaches to further reduce uncertainty regarding NGS coverage and raise awareness of potential financial liability warrant consideration.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.5785","type":"journal-article","created":{"date-parts":[[2025,4,18]],"date-time":"2025-04-18T11:30:39Z","timestamp":1744975839000},"page":"e255785","source":"Crossref","is-referenced-by-count":17,"title":["Claim Denials for Cancer-Related Next-Generation Sequencing in Medicare"],"prefix":"10.1001","volume":"8","author":[{"given":"So-Yeon","family":"Kang","sequence":"first","affiliation":[{"name":"Department of Health Management and Policy, Georgetown University School of Health, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilina","family":"Odouard","sequence":"additional","affiliation":[{"name":"Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carole Roan","family":"Gresenz","sequence":"additional","affiliation":[{"name":"Department of Health Management and Policy, Georgetown University School of Health, Washington, DC"},{"name":"McCourt School of Public Policy, Georgetown University, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2025,4,18]]},"reference":[{"issue":"7","key":"zoi250237r1","doi-asserted-by":"publisher","first-page":"614","DOI":"10.1038\/nbt.3912","article-title":"Payer coverage policies for multigene tests.","volume":"35","author":"Phillips","year":"2017","journal-title":"Nat Biotechnol"},{"issue":"35","key":"zoi250237r2","doi-asserted-by":"publisher","first-page":"2765","DOI":"10.1080\/14796694.2024.2390821","article-title":"Barriers and facilitators to next-generation sequencing use in United States oncology settings: a systematic review.","volume":"20","author":"Ferreira-Gonzalez","year":"2024","journal-title":"Future Oncol"},{"issue":"3","key":"zoi250237r3","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2022.0910","article-title":"Medical debt burdens millions of US adults.","volume":"3","author":"Stephenson","year":"2022","journal-title":"JAMA Health Forum"},{"issue":"3","key":"zoi250237r4","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1001\/jama.2016.16230","article-title":"Variation in the ratio of physician charges to Medicare payments by specialty and region.","volume":"317","author":"Bai","year":"2017","journal-title":"JAMA"},{"issue":"1","key":"zoi250237r7","doi-asserted-by":"publisher","first-page":"4","DOI":"10.20892\/j.issn.2095-3941.2018.0055","article-title":"Next-generation sequencing and its clinical application.","volume":"16","author":"Qin","year":"2019","journal-title":"Cancer Biol 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Chehade","year":"2024","journal-title":"JAMA Netw Open"},{"issue":"11","key":"zoi250237r13","doi-asserted-by":"publisher","first-page":"e1774","DOI":"10.1200\/OP.20.01023","article-title":"Association between Medicare\u2019s national coverage determination and utilization of next-generation sequencing.","volume":"17","author":"Sheinson","year":"2021","journal-title":"JCO Oncol Pract"},{"issue":"1","key":"zoi250237r14","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1002\/jgc4.1459","article-title":"Influence of payer coverage and out-of-pocket costs on ordering of NGS panel tests for hereditary cancer in diverse settings.","volume":"31","author":"Lin","year":"2022","journal-title":"J Genet Couns"},{"issue":"16","key":"zoi250237r18","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2022.40.16_suppl.e13522","article-title":"A preliminary review of adoption of new HCPCS codes for NGS in CMS claims.","volume":"40","author":"Smart","year":"2022","journal-title":"J Clin Oncol"},{"issue":"9","key":"zoi250237r21","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.33316","article-title":"Social determinants of health and insurance claim denials for preventive care.","volume":"7","author":"Hoagland","year":"2024","journal-title":"JAMA Netw Open"},{"issue":"2","key":"zoi250237r22","doi-asserted-by":"publisher","first-page":"649","DOI":"10.1111\/1475-6773.12650","article-title":"Persistent variation in Medicare payment authorization for home hemodialysis treatments.","volume":"53","author":"Wilk","year":"2018","journal-title":"Health Serv Res"},{"issue":"6","key":"zoi250237r23","doi-asserted-by":"publisher","first-page":"1634","DOI":"10.1377\/hlthaff.26.6.1634","article-title":"Implementing evidence-based medicine through Medicare coverage decisions.","volume":"26","author":"Foote","year":"2007","journal-title":"Health Aff (Millwood)"},{"issue":"7","key":"zoi250237r24","doi-asserted-by":"publisher","first-page":"864","DOI":"10.1001\/jama.289.7.864","article-title":"Enrollee appeals of preservice coverage denials at 2 health maintenance organizations.","volume":"289","author":"Studdert","year":"2003","journal-title":"JAMA"},{"issue":"8","key":"zoi250237r26","doi-asserted-by":"publisher","first-page":"958","DOI":"10.1001\/jamadermatol.2022.2214","article-title":"Variation in ratios of submitted charges to allowed Medicare payment for dermatologic services.","volume":"158","author":"Gronbeck","year":"2022","journal-title":"JAMA Dermatol"},{"issue":"9","key":"zoi250237r28","doi-asserted-by":"publisher","first-page":"1395","DOI":"10.1377\/hlthaff.2021.00211","article-title":"Price differences to insurers for infused cancer drugs in hospital outpatient departments and physician offices: study examines differences in prices insurers pay for cancer drugs in hospital outpatient clinics compare with physician offices.","volume":"40","author":"Robinson","year":"2021","journal-title":"Health Aff"},{"key":"zoi250237r5","unstructured":"Data brief: Medicare Part B spending on lab tests increased in 2021, driven by higher volume of COVID-19 tests, genetic tests, and chemistry tests. U.S. Department of Health and Human Services, Office of Inspector General. Published December 2022. Accessed January 31, 2025. https:\/\/oig.hhs.gov\/oei\/reports\/OEI-09-22-00400.pdf"},{"key":"zoi250237r6","unstructured":"CMS\u2019s oversight of Medicare payments for the highest paid molecular pathology genetic test was not adequate to reduce the risk of up to $888 million in improper payments. U.S. Department of Health and Human Services, Office of Inspector General. Published June 21, 2023. Accessed January 31, 2025. https:\/\/oig.hhs.gov\/oas\/reports\/region9\/92203010.asp"},{"key":"zoi250237r8","unstructured":"Next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer. Centers for Medicare & Medicaid Services. Accessed January 31, 2025. https:\/\/www.cms.gov\/medicare-coverage-database\/view\/ncacal-tracking-sheet.aspx?NCAId=296"},{"key":"zoi250237r9","unstructured":"National coverage determination (NCD): next generation sequencing (NGS). Centers for Medicare & Medicaid Services. Published 2020. Accessed January 31, 2025. https:\/\/www.cms.gov\/medicare-coverage-database\/details\/ncd-details.aspx?NCDId=372"},{"key":"zoi250237r15","unstructured":"Consumer Price Index (CPI) databases: all urban consumers (current series). US Bureau of Labor Statistics. Accessed January 31, 2025. https:\/\/www.bls.gov\/cpi\/data.htm"},{"key":"zoi250237r16","unstructured":"Billing and coding: genetic testing for oncology. Centers for Medicare & Medicaid Services. Accessed January 31, 2025. https:\/\/www.cms.gov\/medicare-coverage-database\/view\/article.aspx?articleId=59125&ver=26"},{"key":"zoi250237r17","unstructured":"Billing and coding: MolDX: targeted and comprehensive genomic profile next generation sequencing testing in cancer. Centers for Medicare & Medicaid Services. Accessed January 31, 2025. https:\/\/www.cms.gov\/medicare-coverage-database\/view\/article.aspx?articleid=55197&ver=31&"},{"key":"zoi250237r19","unstructured":"Coding\/reimbursement policy\u2014next generation sequencing (NGS) genetic testing. University of Utah Health Plans. Published July 28, 2021. Accessed January 31, 2025. https:\/\/doc.uhealthplan.utah.edu\/medicalpolicy\/reimb-007.pdf"},{"key":"zoi250237r20","unstructured":"81445, 81450, 81455 (Genomic sequencing procedures and other molecular multianalyte assays). Maryland Department of Health. Accessed January 31, 2025. https:\/\/health.maryland.gov\/mmcp\/Documents\/Targeted%20Genomic%20Sequencing%20Clinical%20Criteria.pdf"},{"key":"zoi250237r25","unstructured":"Cottrill A, Cubanski J, Neumann T, Smith K. Income and assets of Medicare beneficiaries in 2023. KFF. Published February 5, 2024. Accessed January 31, 2025. https:\/\/www.kff.org\/medicare\/issue-brief\/income-and-assets-of-medicare-beneficiaries-in-2023\/"},{"key":"zoi250237r27","unstructured":"CMS Manual System. Pub 100-04 Medicare claims processing. 20.4.2: Site of service payment differential. Centers for Medicare & Medicaid Services. Published 2020. 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