Clinical Evidence Assessment

Independent, unbiased expertise to support evidence-based coverage decisions on new, emerging, and existing medical devices, drugs, procedures, and care processes

Assessment service for medical coverage policy determinations

Medical technology is constantly evolving, and payers need to keep up with the latest changes to make informed coverage decisions. ECRI can help payers save time and resources by providing unbiased, third-party, rapid clinical evidence review to inform medical policy coverage decisions.

ECRI is a nonprofit organization that conducts clinical research on healthcare products and interventions to inform coverage and reimbursement determinations. ECRI experts help payers assess clinical and economic evidence for new medical technologies so payers can make informed decisions on coverage.

Payers are often short-staffed, but still need to review hundreds of medical policies annually, develop new policies, and respond to challenges from providers. ECRI reports can save them 40 hours of research time per topic. In addition to researching the evidence on medical technologies, ECRI provides information on cost-effectiveness, safety, and more. This information helps payers make informed decisions quickly and respond to medical-necessity challenges from providers.

ECRI’s Clinical Evidence Assessment membership services provides evidence that enables you to make informed decisions on coverage, efficiently and confidently, whether a technology topic is new and emerging, or has become a standard of care.

ECRI analysts are available for consultation to help you understand clinical pathways, proven assessment methods, and how to frame key questions, so you consider patient-oriented health outcomes that are critical for making optimal decisions.

ECRI supports payers’ needs for evidence-based information through key capabilities:

Highest standards

Evidence reviews are conducted by doctoral-level clinical research analysts trained in the GRADE methodology of rating evidence strength. This expertise led to the development of ECRI’s proprietary Evidence Bar™, which provides at-a-glance conclusions on key patient outcomes and adverse events.

In-depth evidence analysis

ECRI's in-depth evidence analysis arms payers with comprehensive overviews of new and emerging medical treatments and procedures, as well as new uses for existing medical equipment and technologies. We develop each clinical evidence report through the evaluation of peer-reviewed studies and clinical practice guidelines that we identify through literature searches spanning numerous international databases.

Our research staff employs a range of analyses, including systematic review, recalculation of published data, original statistical data analyses of published study results, and patient and clinical registries. When evidence is sparse, we offer a critical qualitative review of knowns and unknowns. These succinct reports include executive summaries that typically take fewer than five minutes to read , which positions you for efficient coverage decision-making.

Extensive library

ECRI clients have access to a searchable, browsable repository of 2,500-plus reports on new and emerging technologies and standards of care. We publish short descriptions of new drug, device, and biologic approvals with labeled indications and links to FDA approval letters.

With more than 2,500 reports on new, emerging, and standard-of-care drugs, devices, and procedures, no other Health Technology Assessment organization has ECRI’s breadth or depth of topics and expertise. Custom reports are available upon request to support your coverage policy decision process.

Custom research

All clients receive full access to ECRI's library of relevant research. These publications include searchable content on more than 2,500 topics commissioned by payers and providers, with new and updated reports posted weekly.

However, for an added layer of tailored support, choose a membership level that includes custom research. These clients can submit clinical research requests to ECRI’s research team and receive tailored reports on their specified topics.
The process is easy and effective. First, members receive ECRI’s consultation services, during which we work with them to identify key research questions, define the PICOTS, (Patient population, Intervention, Comparators, Outcomes, time frame, Setting of care) and create a project timeline that meets client needs. Then, our master’s-level medical librarians undertake clinical literature searches, and our analysts synthesize information into rapid assessments of the relevant evidence on the topic. We deliver our assessments in several report formats, depending on the subject matter and available clinical literature.

Evidence ratings and peer review

Evidence ratings and peer reviews provide another significant advantage for ECRI members over other Health Technology Assessment organizations. Peer review is a critical step in the development of any evidence report. At ECRI, our team of clinicians and methodologists evaluate each report to ensure that the findings are accurate and clinically relevant. The reports are then rated on relevant factors, including the strength of evidence, consistency of results, and clinical impact. The peer review process relies on ECRI’s network of more than 250 subject matter experts, who help identify potential inaccuracies and provide consensus on our conclusions. The process also helps to identify research topics that are clinically relevant to our members.

Peer reviews and evidence ratings are an important part of our commitment to evidence-based medicine. By ensuring that our reports are accurate, unbiased, and clinically relevant, we're able to provide our clients with the best available evidence to make coverage decisions.

Membership includes access to a broad spectrum of resources and ECRI’s industry experts.

ECRI builds on the discipline and rigor of being 1 of only 9 Evidence-Based Practice Centers designated by AHRQ to provide unbiased, trustworthy, evidence-based clinical reports.

Benefits of membership

  • Unlimited users within the client organization
  • Training/orientation for all users on ECRI evidence tools Educational webinars on methods of health technology assessment and various medical technology topics
  • Access to ECRI experts in evidence analysis and patient safety
  • Custom research requests on topics of interest

Online resources and custom support

  • Searchable, browsable repository of more than 2,500 clinical evidence assessments on new and emerging technologies (including custom reports upon request)
  • Armchair consultations from our research staff about evidence interpretation
  • Technical advisory support for coverage policy meetings

The trusted source of evidence-based information and advice

  • Science-based and backed by ECRI’s 50-plus years of health services research and experience
  • Expertise provided by multidisciplinary evidence-based practice staff, consisting of doctoral-level scientists, clinicians, methodologists, clinical engineers, and master’s-level medical librarians
  • Strict conflict-of-interest rules prohibit ECRI staff and the organization investing in medical device, pharmaceutical, or health insurance companies; consulting for device or pharmaceutical firms, or accepting grants, gifts, or advertising from such companies

Genetic Test Assessment

Genetic breakthroughs are driving increased use of genetic tests and greater complexity of test selection and interpretation. Payers have experienced the inappropriate ordering of genetic tests, resulting in unnecessary and avoidable costs. As a result of this growth and the demand for genetic tests by physicians and consumers, health plans face growing utilization of genetic tests, often with limited data to provide insight into whether a test is clinically useful or appropriate.

Make confident coverage and utilization decisions about genetic and genomic tests with evidence-based assessments and data-driven guidance that other health technology assessment organizations simply cannot provide.

Genetic Test Assessment is a resource that guides clinical coverage policy and utilization decisions about genetic, genomic, and proteomic tests. This curated database of the most clinically relevant genetic tests provides regulatory and coverage status, insight into clinical validity and clinical utility, and useful overviews on a wide range of tests to support coverage policy development and implementation of clinical practice guidelines. ECRI experts continuously monitor the rapidly expanding genetic test marketplace to help payers quickly determine appropriate test coverage and laboratory contract. Membership enables you to:

  • Access a curated database of genetic tests, including multigene panels and companion diagnostics
  • Use ECRI’s visual decision-making tool, The Evidence Bar™, which provides the bottom line on clinical validity and clinical utility evidence
  • Compare up to four genetic tests based on 25 attributes, including coverage and CPT® codes
  • Access relevant guidelines and standards along with evidence-based test reviews
  • Access ECRI’s directory of genetic test labs with key contact information
  • Request custom evidence reviews

ECRI’s genetic counselors and doctoral-level experts in molecular and cell biology help you answer questions such as:

  • Which tests are best and which should be avoided?
  • Which tests have robust clinical utility evidence?
  • How will a test benefit a given patient?
  • Which payers cover a specific test?

For more than half of the lives covered in the United States, ECRI’s technology assessments serve as key coverage decision-making resources for government payers and commercial health plans.

Interested in learning more?

Setup a consultation with an ECRI expert to learn more about how to inform medical policy coverage decisions.