Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges

Deverka, Patricia A.; Dreyfus, Jennifer C.

doi:10.1111/jlme.12160

Cited by 50 publications

(50 citation statements)

References 47 publications

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“…The advent of precision medicine brought forth much enthusiasm, but acceptance has been somewhat stagnant due to the shortage of payers willing to provide coverage and reimbursement. This problem is primarily due to the lack of evidence for clinical utility (5 ). Clinical utility unites effectiveness with benefits, which often stem from clinical trial results.…”

Section: Introductionmentioning

confidence: 99%

“…However, because this field is rapidly progressing in both the preclinical and clinical venues, the need for a higher level of specificity in identifying molecular markers for targeted therapies is imperative and continues to evolve. Recruitment and reporting of outcome data from biomarker-targeted clinical trials are aimed at fulfilling criteria for US Food and Drug Administration (FDA) 5 submission and could help establish evidence for payer reimbursement. The advent of precision medicine brought forth much enthusiasm, but acceptance has been somewhat stagnant due to the shortage of payers willing to provide coverage and reimbursement.…”

Section: Introductionmentioning

confidence: 99%

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Clinical Trials in Precision Oncology

et al. 2016

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BACKGROUND Availability of genomic information used in the management of cancer treatment has outpaced both regulatory and reimbursement efforts. Many types of clinical trials are underway to validate the utility of emerging genome-based biomarkers for diagnostic, prognostic, and predictive applications. Clinical trials are a key source of evidence required for US Food and Drug Administration approval of therapies and companion diagnostics and for establishing the acceptance criteria for reimbursement. CONTENT Determining the eligibility of patients for molecular-based clinical trials and the interpretation of data emerging from clinical trials is significantly hampered by 2 primary factors: the lack of specific reporting standards for biomarkers in clinical trials and the lack of adherence to official gene and variant naming standards. Clinical trial registries need specifics on the mutation required for enrollment as opposed to allowing a generic mutation entry such as, “EGFR mutation.” The use of clinical trials data in bioinformatics analysis and reporting is also gated by the lack of robust, state of the art programmatic access support. An initiative is needed to develop community standards for clinical trial descriptions and outcome reporting that are modeled after similar efforts in the genomics research community. SUMMARY Systematic implementation of reporting standards is needed to insure consistency and specificity of biomarker data, which will in turn enable better comparison and assessment of clinical trial outcomes across multiple studies. Reporting standards will facilitate improved identification of relevant clinical trials, aggregation and comparison of information across independent trials, and programmatic access to clinical trials databases.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical Trials in Precision Oncology

et al. 2016

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“…However, a key barrier to more wide-scale application remains: the lack of an operational infrastructure for logistics and revenue management in the clinical context. 10 Current models lack efficient processes for utilization management, regulatory compliance, clinical quality assurance, and results reporting. In addition, current attempts to use genomic sequencing have failed to achieve long-term financial sustainability 10 in that they do not include sufficient systems for adequate billing and reimbursement.…”

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confidence: 99%

“…10 Current models lack efficient processes for utilization management, regulatory compliance, clinical quality assurance, and results reporting. In addition, current attempts to use genomic sequencing have failed to achieve long-term financial sustainability 10 in that they do not include sufficient systems for adequate billing and reimbursement. In particular, clinical genomics requires navigating many nontechnical challenges beyond those required for research applications.…”

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confidence: 99%

“…Even those research-focused laboratories that have obtained a Clinical Laboratory Improvement Amendments certification generally have not overcome the more significant barrier related to effective integration of genomic results into clinical diagnosis and continuous patient management. 4,11 To overcome the nontechnical barriers currently limiting the scope and availability of clinical genomic sequencing, 10 we sought to define and implement systems and processes that could enable logistically scalable and financially sustainable clinical genomics. To facilitate the alignment of the numerous individuals and teams encompassing diverse skill sets and performing highly varied functions, we used an iterative development approach (Agile).…”

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Health Care Infrastructure for Financially Sustainable Clinical Genomics

Lennerz

McLaughlin

Baron

et al. 2016

The Journal of Molecular Diagnostics

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Next-generation sequencing has evolved technically and economically into the method of choice for interrogating the genome in cancer and inherited disorders. The introduction of procedural code sets for whole-exome and genome sequencing is a milestone toward financially sustainable clinical implementation; however, achieving reimbursement is currently a major challenge. As part of a prospective quality-improvement initiative to implement the new code sets, we adopted Agile, a development methodology originally devised in software development. We implemented eight functionally distinct modules (request review, cost estimation, preauthorization, accessioning, prebilling, testing, reporting, and reimbursement consultation) and obtained feedback via an anonymous survey. We managed 50 clinical requests (January to June 2015). The fraction of pursued-to-requested cases (n Z 15/50; utilization management fraction, 0.3) aimed for a high rate of preauthorizations. In 13 of 15 patients the insurance plan required preauthorization, which we obtained in 70% and ultimately achieved reimbursement in 50%. Interoperability enabled assessment of 12 different combinations of modules that underline the importance of an adaptive workflow and policy tailoring to achieve higher yields of reimbursement. The survey confirmed a positive attitude toward self-organizing teams. We acknowledge the individuals and their interactions and termed the infrastructure: human pipeline. Nontechnical barriers currently are limiting the scope and availability of clinical genomic sequencing. The presented human pipeline is one approach toward long-term financial sustainability of clinical genomics. (J Mol Diagn 2016, 18: 697e706; http://dx

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Yield of whole exome sequencing in undiagnosed patients facing insurance coverage barriers to genetic testing

Reuter

Kohler

Bonner

et al. 2019

Journal of Genetic Counseling

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Background Despite growing evidence of diagnostic yield and clinical utility of whole exome sequencing (WES) in patients with undiagnosed diseases, there remain significant cost and reimbursement barriers limiting access to such testing. The diagnostic yield and resulting clinical actions of WES for patients who previously faced insurance coverage barriers have not yet been explored. Methods We performed a retrospective descriptive analysis of clinical WES outcomes for patients facing insurance coverage barriers prior to clinical WES and who subsequently enrolled in the Undiagnosed Diseases Network (UDN). Clinical WES was completed as a result of participation in the UDN. Payer type, molecular diagnostic yield, and resulting clinical actions were evaluated. Results Sixty‐six patients in the UDN faced insurance coverage barriers to WES at the time of enrollment (67% public payer, 26% private payer). Forty‐two of 66 (64%) received insurance denial for clinician‐ordered WES, 19/66 (29%) had health insurance through a payer known not to cover WES, and 5/66 (8%) had previous payer denial of other genetic tests. Clinical WES results yielded a molecular diagnosis in 23 of 66 patients (35% [78% pediatric, 65% neurologic indication]). Molecular diagnosis resulted in clinical actions in 14 of 23 patients (61%). Conclusions These data demonstrate that a substantial proportion of patients who encountered insurance coverage barriers to WES had a clinically actionable molecular diagnosis, supporting the notion that WES has value as a covered benefit for patients who remain undiagnosed despite objective clinical findings.

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Clinical Integration of Next Generation Sequencing: Coverage and Reimbursement Challenges

Cited by 50 publications

References 47 publications

Clinical Trials in Precision Oncology

Clinical Trials in Precision Oncology

Health Care Infrastructure for Financially Sustainable Clinical Genomics

Yield of whole exome sequencing in undiagnosed patients facing insurance coverage barriers to genetic testing

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