Table 2.

Challenges with potential solutions in rank order (based on percentage of panelists who selected the solution as ‘best to pursue’ in round four).

Challenges with potential solutions	Best to pursue (%)
Challenge A: Different payers have different evidentiary standards for assessing clinical utility, which leads to inconsistent policies on coverage and reimbursement for NGS-based tests
Multistakeholder consensus panels that include payers and patients should be convened to set evidentiary standards	37
Expert panels (e.g., ACMG, NAM, EGAPP, etc.) should develop recommendations for evidentiary standards for all payers to use	33
Fund research on methods of establishing standards, and pilot different approaches to determine the best one	15
All payers, public and private, should cooperate to develop consistent standards	7
No policy action needed. Accept variability in evidence standards and coverage inconsistency among payers and focus on other challenges	7
There should be a government or legislative mandate for payers to cover all NGS tests	0
There should be a legislative mandate for payers to cover FDA-approved or cleared tests only	0
Challenge B: Diagnostic companies are able to maintain proprietary databases on a substantial variety of clinically meaningful mutations found in patients. Refusal to share this type of information could impede the development of clinically useful NGS tests.
Make data sharing and the possibility of independent verification a condition of approval/clearance, certification or accreditation (specifically, a requirement set forth by FDA, CMS/CLIA and/or CAP)	54
Use positive-economic incentives so that payers reimburse more for tests from laboratories that share data	18
Use negative incentives. For example, payers refuse to pay, or healthcare providers refuse to order tests, if there is no data sharing	14
Make data sharing and sufficient transparency for independent verification a condition of funding (specifically, a requirement for NIH funding)	14
Public shaming of companies that do not share	0
Do nothing. You cannot or should not compel data disclosure in this space	0
Challenge C: There is a lack of consensus about what mechanisms should be used to address the clinical risks to patients from NGS-based laboratory-developed tests. For example, there is continued debate as to whether FDA oversight should be used to address these risks
Use FDA oversight as a mechanism to address the risks to patients from NGS-based LDTs	41
Use laboratory accreditation and proficiency testing by professional societies as a mechanism to address the risks to patients from NGS-based LDTs	1
Use payers to address certain risks to patients from NGS-based LDTs, specifically, restrict payment to accredited laboratories	7
Use payers to address certain risk to patients from NGS-based LDTS, specifically, condition coverage on consultation with a genetic counselor	7
Rely on state regulation to address the risks to patients from NGS-based LDTs	4
Use payers to address certain risks to patients from NGS-based LDTs, specifically, restrict reimbursement to FDA-approved or cleared tests	0
Rely on self-regulation to address the clinical risks to patients from NGS-based LDTs	0
Challenge D: There is a lack of standardization for reporting NGS test results (e.g., determining which results to report, how to effectively communicate findings, and to whom those findings should be communicated
A consensus panel could designate a general framework and nomenclature for how to present information (formatting reports)	82
No action at this point. It is premature to come out with any guidelines on formatting reports	14
Standardize communication to patients for providers and genetic counselors	4

ACMG: American College of Medical Genetics; CAP: College of American Pathologists; CLIA: Clinical Laboratory Improvement Amendment; CMS: Centers for Medicare and Medicaid Services; EGAPP: Evaluation of Genomic Applications in Practice and Prevention; NAM: National Academies of Medicine; LDT: Laboratory-developed test; NGS: Next-generation sequencing.