A clinical review is any structured evaluation of medical care, treatment decisions, or health-related evidence to determine whether the care provided (or requested) meets accepted standards. The term appears across several distinct areas of healthcare: hospitals use clinical reviews to catch errors and improve patient safety, insurance companies use them to decide whether a treatment is medically necessary, and regulatory agencies like the FDA use them to evaluate whether new drugs should be approved. The common thread is a systematic look at clinical evidence to make a judgment about quality, necessity, or safety.
Clinical Review for Patient Safety
In hospitals, clinical review is the process of retrospectively examining potential errors or gaps in medical care, with the goal of improving future practice. This type of review goes by several names depending on the setting: peer review, adverse event review, sentinel event review, or root cause analysis. Regardless of the label, the purpose is the same. A committee of physicians examines what happened during a patient’s care and determines whether the treatment met prevailing standards.
This practice gained urgency after the Institute of Medicine’s 1999 report “To Err is Human” estimated that 44,000 to 98,000 deaths occur annually in the United States as a result of medical errors. That report was a turning point in how healthcare organizations think about mistakes. Rather than treating errors as individual failures, hospitals began building systems to detect patterns, identify weaknesses, and fix problems before they cause serious harm.
Today, clinical peer review is mandated across all U.S. hospitals and is required by The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for hospital accreditation. The majority of this peer review happens through retrospective chart review, where a committee evaluates a physician’s clinical work after the fact. Reviews can also be triggered by specific concerns, such as substandard physician performance or questionable care decisions. Some states, like Oregon, extend the review framework beyond diagnosis and treatment to include factors like professionalism and communication skills.
Clinical Review in Insurance Decisions
When your health insurance company reviews a request for treatment or a submitted claim, that process is also called clinical review. In this context, it’s part of utilization management, where the insurer determines whether a proposed service is medically necessary and covered under your plan. This is the version of clinical review that most people encounter personally, often when they need prior authorization for a procedure, medication, or specialist visit.
The review can happen at three different points:
- Prospective review takes place before you receive the service. This is what happens during prior authorization: your provider submits a request with supporting medical documentation, and the insurer makes an affirmed or non-affirmed decision before treatment begins.
- Concurrent review happens during your course of treatment, typically for hospital stays or ongoing therapies, to determine whether continued care is still necessary.
- Retrospective review occurs after services have already been rendered, when the insurer evaluates whether the completed treatment was appropriate for payment.
Reviewers at insurance companies use standardized, evidence-based criteria to make these decisions. Two of the most widely used guideline sets are MCG Care Guidelines and InterQual criteria. MCG, for example, is used by thousands of hospitals, a majority of health plans, and many state and federal government agencies. These guidelines cover inpatient care, ambulatory care, behavioral health, post-acute care, chronic care, and transitions of care, giving reviewers a consistent framework for evaluating whether a specific treatment fits the clinical situation.
Who Performs Clinical Reviews
Clinical reviewers are licensed healthcare professionals, not administrative staff. For organizations like IPRO, which conducts reviews for Medicare and other programs, reviewers must hold a current, non-restricted medical license in a U.S. state, be board-certified by the American Board of Medical Specialties, maintain active hospital privileges, and have at least five years of active clinical practice following subspecialty residency. Proof of academic appointments and published work may also be required.
In insurance settings, initial reviews are often handled by registered nurses working from established criteria, with physician reviewers stepping in for cases that don’t clearly meet guidelines or involve a denial. The principle is that someone with relevant clinical training and experience evaluates the medical evidence, not someone without a healthcare background.
Clinical Review at the FDA
The FDA uses clinical review as a core part of its drug approval process. When a pharmaceutical company submits a new drug application, a team of physicians, statisticians, chemists, and pharmacologists reviews the company’s clinical trial data and proposed labeling. The review follows a structured framework with three main components.
First, the team analyzes the target condition and the existing treatments available, which provides context for evaluating whether the new drug adds value. Second, they assess the benefits and risks shown in clinical data. The FDA generally expects results from two well-designed clinical trials to confirm that findings aren’t due to chance or bias, though for rare diseases where multiple trials aren’t feasible, convincing evidence from a single trial can be sufficient. Third, the team evaluates strategies for managing the drug’s risks, which can range from clear labeling to formal Risk Evaluation and Mitigation Strategies for higher-risk medications. A drug is approved when its health benefits outweigh its known risks.
What Happens When a Review Results in a Denial
If a clinical review leads your insurer to deny a claim or refuse coverage for a requested treatment, you have the right to appeal. Insurers are required to tell you why they denied the claim and how to dispute the decision.
There are two appeal pathways. An internal appeal asks the insurance company to conduct a full and fair review of its own decision. If the case is urgent, the company must expedite this process. If the internal appeal doesn’t resolve the issue, you can request an external review, where an independent third party evaluates the claim. External review is significant because it takes the final decision out of the insurance company’s hands entirely. These rights apply to most health plans under the Affordable Care Act.
How Technology Is Changing the Process
Artificial intelligence is beginning to reshape clinical review workflows, particularly in research-oriented reviews like systematic reviews of medical literature. AI tools can now automate study screening, data extraction, and quality assessment. For example, tools using natural language processing can identify relevant sections of clinical trial reports and extract key findings with high accuracy. One evaluation found that a large language model achieved 96% specificity and 93% sensitivity when screening studies against inclusion and exclusion criteria.
In the insurance and hospital quality space, automation is being used to flag cases that need human review, pre-populate clinical data for reviewers, and reduce the time spent on routine administrative steps. The clinical judgment still comes from a licensed professional, but the volume of paperwork involved in getting to that judgment is shrinking.