In the constantly evolving world of medical research and development, cutting-edge treatments start out in a clinical trial setting and, if proven safe and effective, will become acceptable in the day-to-day practice settings of health care providers.
Some advanced cancer treatments and biological therapies are just two examples of treatment methods that will pass through the well-worn phases of accepted therapies. After considerable research, a treatment will go through trials, reviews, more trials, studies and, finally, it may gain approval from the Food and Drug Administration (FDA) to treat a targeted disease or condition.
However, not all potential therapies gain clearance for treatment, and some services or procedures remain experimental and investigational (E&I) due to insufficient evidence to grant coverage.
Independent review organizations (IROs) are often called on to handle medical reviews involving E&I services or procedures.
Guided By Scientific Evidence
When it comes to E&I services, instances of rare diseases or conditions, brand-new biological drugs hitting the market and treatment methods that use an FDA-approved drug for a non-approved disease state are some examples of challenging E&I review cases, says Seth Lewin, M.D., vice president and chief medical officer with NYCHSRO/MedReview Inc. in New York, N.Y.
When conducting E&I reviews, approvals for a treatment or procedure in question hinge on several factors, but having the reviewers find “sufficient scientific evidence to support the safety and efficacy of the issue under review is of great importance to the review process,” says Joyce Muller, president and CEO of IMEDECS, an IRO based in Harleysville, Pa.
When taking up challenging E&I cases, IROs adhere to diligent standards that include:
- Licensed, credentialed and active clinical reviewers. IROs have immediate access to physicians and allied health care practitioners who are at the vanguard of medical treatments and services. These physicians are active in medical practice and stay up-to-date on the latest evidence-based studies and services in their field of specialty.
- Decisions that are supported by the latest evidence in peer-reviewed medical literature. Clinical reviewers are considered experts in their field, and many IRO reviewers are affiliated with or have relationships with medical centers of excellence and research hospitals, linking them to the latest knowledge and resources of accepted medical practices and treatments. After reviewing a case, IRO written determinations and rationale are supported with references from peer-reviewed medical research literature.
- Advanced, ongoing education and training. The rigorous credentialing and reviewer training programs for IROs are designed to ensure access to reviewers who are knowledgeable about the most current peer-reviewed literature and evidence-based medicine.
In addition to assessing whether the recommended service or treatment has been approved by the FDA for the patient’s condition, IROs also determine whether “the expected benefits of the recommended or requested health care service or treatment is more likely than not to be beneficial to the covered person than any available standard health care services or treatment,” according to the NAIC Uniform Health Carrier External Review Model Act, a blueprint for evidence-based medical reviews.