Despite the proven value of polymerase chain reaction (PCR)-based syndromic panels, inconsistent reimbursement policies throughout the United States have created geographic disparities in treating people with complicated urinary tract infections (cUTIs) and other illnesses.
At the heart of the issue is the lack of reimbursement for syndromic PCR panels containing six or more pathogens in regions governed by the Molecular Diagnostic Services Program (MolDX), a coverage policy program adopted by four Medicare Administrative Contractors (MACs) across 28 U.S. states. By contrast, MACs outside the MolDX bill syndromic panels under standard rules, allowing only one syndromic panel per beneficiary per day, and specifically deeming panels that exceed medical-necessity criteria “not reasonable and necessary.”
Although PCR tests used to be more broadly covered, beginning in April 2022, MolDX explicitly separated targeted panels—those that test for five pathogens or fewer—from expanded syndromic panels that test for at least six pathogens, and imposed strict coverage limits on the latter (MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing. CMS.gov. Apr 17, 2022. bit.ly/CMS_PCR).
The policy means that while smaller panels are reimbursed, the larger, more comprehensive panels necessary for complicated cases routinely are denied coverage. Although the policy was intended in part to curb perceived overuse of the testing by general practitioners, it often results in blanket denial—even when the panels are prescribed by specialists.
“In practical terms, this means that laboratories in MolDX jurisdictions must navigate a far more onerous preapproval and documentation process for expanded syndromic panels,” said Moustafa Kardjadj, PhD, the data management and biostats lead at the consulting firm Dicentra, in Toronto. “This creates a scenario where two patients with identical clinical presentations receive different access to advanced diagnostics solely based on MAC jurisdiction.”
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The downstream effect of such reimbursement gaps is clear, Dr. Kardjadj said. Patients in MolDX-covered regions may go undiagnosed or be misdiagnosed due to limited panel use, resulting in prolonged illness, recurrent infections and suboptimal outcomes. Meanwhile, patients in non-MolDX states benefit from broader access and more personalized treatment decisions. This can be particularly challenging when managing older patients, who are often covered by Medicare and can be susceptible to recurrent and cUTIs.
Dr. Kardjadj has seen the benefit of PCR in his own research. In one study, he and his co-investigators found that PCR testing led to diagnoses that culture and sensitivity had missed in patients with cUTIs (Diagn Microbiol Infect Dis 2025;111[3]:116646).
Losing Tools From the Toolbox
At the clinic level, losing the ability to ensure coverage for once-used, well-proven tests is creating frustration, particularly when clinicians in neighboring states may be asked to follow a different set of regulations.
“Meeting medical necessity has never been an issue, and I don’t have a problem with it being in the hands of specialists to decide who should receive the expanded panels,” said Michael Dukes, the practice administrator at Albany Urology Clinic, in Georgia. “What I don’t think is appropriate is not being allowed to use these tests simply because we are in a MolDX state.
“It’s like we’re being given a toolbox and then told we can only use some of the available tools,” Mr. Dukes said.
The ramifications of the current MolDX policy are extending beyond Medicare. Since private insurers often model coverage decisions based on Medicare policies, several also are declining reimbursement now for extended syndromic panels, focusing coverage on small, targeted multiplex tests used in high-risk settings.
“This cautious stance by both public and private insurers is causing providers to abandon routine use of expanded syndromic panels despite their proven clinical advantages,” Dr. Kardjadj told Infectious Disease Special Edition.
Raising Awareness
Efforts are ongoing to encourage MolDX to recognize the convincing peer-reviewed evidence demonstrating improved patient outcomes with syndromic panel use and to approve reimbursement. However, Dr. Kardjadj stressed that raising awareness among healthcare professionals regarding the existing coverage disparities is critical.
“Until Medicare and commercial payors align their policies with the strong clinical evidence supporting broad molecular testing, patients requiring respiratory or GI syndromic panels will continue to encounter the same access challenges seen in cUTI care,” he said.
The current policy, Dr. Kardjadj continued, creates discrimination and inequality.
“It’s really about making sure the right patients get the right care—no matter where they live,” he said.
Mr. Dukes and Dr. Kardjadj reported no relevant financial disclosures.
This article is from the August 2025 print issue.