Beyond the Result: Digging Deeper into Diagnostic Stewardship and Test Reimbursement

Guests from the University of Pennsylvania and the MolDX program at Palmetto offer insights into the evolution of diagnostic stewardship principles, dealing with data, and managing reimbursement in a changing landscape

Diasorin’s Beyond the Result podcast is still going strong! In episodes five and six, Angelo Rago hosted discussions about diagnostic stewardship and reimbursement coverage trends. Guest experts were Kyle Rodino, PhD, Assistant Director of the Clinical Microbiology Laboratory at the Hospital of the University of Pennsylvania, and Gabriel Bien-Willner, MD, PhD, Medical Director of MolDX and Chief Medical Officer at Palmetto GBA.

We encourage you to watch or listen to each podcast, but for a quick overview, here are some highlights from the conversations.

Diagnostic stewardship is a team sport

Dr. Rodino, a champion of diagnostic stewardship efforts, noted that these programs cannot be achieved through the clinical laboratory alone. For optimal outcomes, and to ensure buy-in from other departments, diagnostic stewardship initiatives should include perspectives from hospital administration, patient-facing clinical care teams, and laboratory management. Also, communication is key for raising awareness about new testing best practices. This can come from healthcare providers or leadership members who advocate for the change, as well as from tip sheets and other materials developed by the lab team. “Building relationships is definitely a piece that is important if you’re going to be successful in stewardship,” Dr. Rodino said.

Conversations should always focus on what’s best for the patient, rather than on simply trying to cut costs, he added. That isn’t to say diagnostic stewardship has no effect on costs, however. For example, replacing a send-out test with an in-house one to generate faster results and enable better care for patients often has the added benefit of replacing a higher-cost test with a more economical one.

In his hospital system, Dr. Rodino’s lab team is helping clinicians choose the right test earlier in the patient care journey, which makes it possible to deliver diagnoses faster and get patients on an appropriate intervention sooner. “If we’re all doing our part, I think I can assume we’re headed towards the best speed of care, the best diagnostic outcome, the best treatment,” he said.

Honor the history, focus on the future

While diagnostic stewardship may seem like a recent buzzword, it’s rooted in principles that have been central to laboratory medicine for decades. Dr. Rodino raised a fascinating example from the first stewardship initiative at his institution, which was published in 1990. The study aimed to determine whether hospitalized patients receive any benefit from a stool culture administered more than three days into their stay. The answer is no, as the study found that community-acquired pathogens cannot be recovered at that point, and that patients did not receive improved care from those test results. That three-day rule is now almost universally observed at hospital facilities, Dr. Rodino said. In fact, a team at Johns Hopkins recently recreated this study with modern enteric pathogen panels and got the same result.

But stewardship studies of the past, and most of the current laboratory information systems, did not anticipate an era in which massive amounts of data would be available and would be more helpful when integrated and mined, Dr. Rodino added. And in an era of hospital mergers and acquisitions, labs often deal with information systems that do not play well together. Finding better ways to gather data and perform analyses might make diagnostic stewardship efforts even more effective. Ultimately, a more nuanced approach could bring together the concepts of diagnostic stewardship and precision medicine, using data-focused methods to pinpoint the best tests for each patient scenario, such as selecting the most appropriate subset of targets from a syndromic panel rather than running the entire panel.

Hear this and more from Dr. Rodino on Beyond the Result Episode 5 or wherever you find your podcasts.

The power of the purse: molecular diagnostic test reimbursement

In his podcast episode, Dr. Bien-Willner offered the payer’s perspective, sharing insights from his role at Medicare contractor Palmetto and efforts to educate payers on covering molecular diagnostic tests.

If you’ve ever wondered why tests need a Z identifier code, Dr. Bien-Willner provided a helpful explanation. At the lab test level, CPT codes are imprecise; payers can’t tell whether a genetic test panel covered five genes or 50 genes. Palmetto launched a test registry designed to give payers more detail about what a test does, how it’s run, and what results it produces. This registry, which gives each test a Z code, has been so successful that many other Medicare contractors now participate in the program. Overall, the goal is to let payers understand what service was rendered and why, Dr. Bien-Willner said.

The conversation also included our favorite analogy used on a Beyond the Result podcast so far: car repair pricing! In an explanation of Medicare’s “reasonable and necessary” threshold for providing coverage, Dr. Bien-Willner gave the example of two mechanics who examine a car and propose two different solutions with wildly different costs. It’s not that either mechanic is necessarily wrong about how to fix the problem, he said, just as two physicians might have very different approaches and costs for treating the same patient. Ultimately, he said, the payers’ power of the purse determines which services become successful and which never get ordered because they’re not covered.

Palmetto’s MolDX program is often the first to cover new tests, Dr. Bien-Willner said, encouraging the clinical laboratory community to speak with his team to get help meeting payer requirements. He also noted the importance of crafting coverage policies so they’ll keep up with a rapidly changing test landscape. One example of this in practice is Palmetto's local coverage determination for next-generation sequencing technology in cancer testing. It was written in 2018 and hasn’t required an update despite the many technical advances in the sequencing field since then. One of the first policies that wasn’t about a specific test from a specific company, it could serve as a model for other molecular diagnostic testing in the future, Dr. Bien-Willner added.

Hear this and more from Dr. Bien-Willner on Beyond the Result Episode 6 or wherever you find your podcasts.

Stay tuned!