Medicare Contractor Proposes Coverage of Urine Biomarker Tests for Microhematuria

Novitas Solutions, a Medicare administrative contractor, has proposed covering urine-based biomarker tests used to help decide whether patients with microscopic blood in the urine need a cystoscopy. The proposed local coverage determination (LCD), titled Urine-based Biomarkers in Patients with Microhematuria (DL40378), was posted to the Medicare Coverage Database on May 14, according to the CMS record.

Test maker Pacific Edge said on May 15 that the companion billing and coding article (DA60424) explicitly lists its Cxbladder Triage (0363U) and Cxbladder Triage Plus (0420U) tests as proposed to be reimbursable. "No other urine-based biomarkers are included in the draft coding article," the company said.

A narrow covered population

Under the draft, a urine biomarker test used to aid risk stratification in microhematuria is considered reasonable and necessary only when all listed conditions are met. The patient must have microhematuria with other causes ruled out, no current or previous urothelial or other urologic cancer, and be considered intermediate risk under published guidelines. The patient must not have had a cystoscopy or the same or a similar test in the previous six months, and must have been counseled and intend to forgo cystoscopy depending on the test result.

The draft lists as not reasonable and necessary any use in patients classed as low risk or high risk under specialty society guidelines, use within six months of a cystoscopy and repeat testing within six months. Tests must also show accurate risk stratification to inform the cystoscopy decision, documented clinical validity in peer-reviewed literature, and sensitivity or specificity for detecting urothelial carcinoma equal or superior to other accepted methods, according to the draft. Novitas said it evaluated the published evidence using the GRADE methodology.

In its rationale, quoted by Pacific Edge, Novitas wrote that "limited coverage for UBB testing is supported when applied within a narrowly defined clinical context."

What Pacific Edge expects

Pacific Edge said the draft distinguishes microhematuria patients from those covered by an existing Novitas non-coverage LCD, Genetic Testing in Oncology: Specific Tests (L39365), which it described as applying to patients with cancer or a substantiated suspicion of cancer. The company said it will engage with Novitas to seek claim-by-claim reimbursement for both tests while the policy is in draft.

"This new draft LCD establishes hematuria evaluation as a covered Medicare benefit for the first time," said Chief Executive Peter Meintjes. The company said the Medicare price for Triage Plus is US$1,328 per test, compared with the US$760 it received for its legacy Cxbladder products.

According to Pacific Edge, publication starts a notice-and-comment period of at least 45 days during which Novitas will hold a public meeting and accept written comments. Novitas then has 12 months to publish a final LCD or withdraw the draft, and a final LCD would take effect 45 days after publication, the company said. Novitas convened a Contractor Advisory Committee meeting on the evidence on February 19, according to Pacific Edge.

The announcement came as Pacific Edge was raising money: the company said a NZ$25.4 million share placement closed on May 12 and a retail offer of up to NZ$6 million to existing New Zealand shareholders opened on May 14.