FDA officials: Payers should be more involved in evidence generation

Payers should be more involved in evidence generation because it will help bring about better coverage decisions, policies, and claims data for real-world evidence in medical product evaluation, staff from the US Food and Drug Administration (FDA) argued in a recent editorial.

“Evidence generation serves payers’ most important mission—to improve their beneficiaries’ health,” Ali B. Abbasi, and colleagues from the FDA, including FDA Commissioner Robert Califf, wrote in their special communication. “Although payers mainly accomplish this task through coverage of health care services and medical products, payers have a responsibility to participate in generating evidence that can help ensure the right patient gets the right treatment at the right time.”

FDA sees payers as “a crucial partner” for bridging gaps in evidence generation because they are uniquely suited to “shape the conduct of research in the context of health care delivery,” the authors said.

Steps payers can take to support evidence generation in a way that improves public health include increasing communication with health systems about evidence generation, developing strategies for greater involvement in clinical trials, and improving claims data quality. The authors said private payers could also learn from the lessons of public payers like the Centers for Medicare & Medicaid Services (CMS) to lower costs and improve public health.

“An important first step is increasing payer involvement in conversations about clinical trials,” they said. “Too often, payer representatives are not at the table during high-profile summits focused on improving the conduct of clinical trials. These meetings serve the important functions of identifying areas of shared interest and prioritizing opportunities for collaboration.”

Engagement in clinical trials

Payers should consider streamlining routine costs of care for participants in a clinical trial, deciding with investigators during a trial’s design phase to approve trial-related care elements, as opposed to the current environment where trial participants experience denials and delays for care that may discourage participation.

“Beyond covering routine care costs, payers could consider covering certain experimental interventions and may be particularly motivated to do so for clinical trials that reduce health expenditures,” the authors said. “[P]ayers could accelerate the generation of evidence that would help them make coverage decisions, reduce expenditures during the conduct of the trial, and answer important questions that affect the health of their covered population.”

Conducting some trials without payer involvement may prove difficult, the authors said. “Randomized trials have shown medical management to be as effective as surgical procedures for a number of indications, which is information that is important for coverage criteria. However, health systems and clinicians might be reluctant to participate in such trials because of lost surgical revenue, creating recruitment challenges for these trials and limiting the number of procedures that can be evaluated,” they noted. “To enable such trials, payers could implement payments for both medical and surgical treatments within the context of clinical trials.”

Concerning trial design, Abbasi and colleagues said payers could discuss data during the design phase of a clinical trial that would lead to coverage if a product received market approval. They noted that FDA is already encouraging discussions between payers and manufacturers through initiatives like the Total Product Life Cycle Advisory Program. “This step could potentially improve the efficiency of the premarket review process and facilitate rapid postmarket access to devices,” they said.

Improving claims data quality

Claims data have a number of limitations that payers could potentially address that would result in better coverage decisions and improvement of public health. For instance, payers could incorporate unique device identifiers in claims data to improve safety surveillance across the device’s life cycle. Payers could also increase the value of claims data by leveraging it for prospective clinical trials by streamlining the collection and processing of data to facilitate early access, and being more specific in their coding.

Another area payers could potentially see benefits is in using high-quality claims data to quickly process prior authorizations. The authors used the example of payers asking clinicians to document recurrence of cancer in claims data and then automating approval of future diagnoses and treatments.

They noted that CMS is attempting to improve the quality of data received from oncology clinicians and private payers through their voluntary CMS Enhancing Oncology Model, which requires reporting data to CMS that is not routinely captured in claims data. “If successful, this model could offer a template for future efforts to improve the quality of payer data,” they said.

“By joining these efforts and learning from the experience of public payers, private payers can contribute to better alignment of health care funding with strategies and interventions that improve health, demonstrated through robust evidence generation across the US health care system,” the authors concluded.

JAMA Abbasi et al.

FDA officials: Payers should be more involved in evidence generation

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