The importance of mounting a robust response to urine PCR testing denials and clawbacks

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In recent years, the utilization of advanced diagnostic tools, such as multiplex polymerase chain reaction (PCR) urine testing, has increased dramatically. These tests may offer more precise and timely diagnoses, enabling clinicians to prescribe targeted antibiotic therapies and improve patient outcomes. However, health care providers often face significant financial and administrative challenges when payers deny claims or demand recoupments for urine PCR tests. Recently, Frier Levitt represented a urology and urogynecology group (the “Group”) that encountered such obstacles. Their experience highlights the critical importance of mounting a robust response to urine PCR testing denials and clawbacks.

Daniel B. Frier, Esq.
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Theresa M. DiGuglielmo, Esq.
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Nicole M. DeWitt, Esq.
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The Group’s largest payer (the “Payer”) conducted an audit and subsequently sought an aggregate overpayment for Medicare and Medicare Advantage urine PCR claims totaling nearly $500,000. After exhausting the Payer’s internal appeals process, the Payer’s position was unchanged. The Payer sought a 100% recoupment for the audited claims, and based on the expectation that future claims would be either denied or later recouped, our client had no choice but to curtail its use of urine PCR testing. Unwilling to let such an important patient care issue go unchallenged, the Group authorized our firm to initiate direct communications with the Payer’s legal counsel. Through this diplomatic channel, we successfully negotiated the following:

(i) a substantially reduced monetary settlement of past claims, without admission of wrongdoing by the Group or any of its individual providers;

(ii) a peer-to-peer conference with the Payer’s medical director to discuss the utility of urine PCR testing over standard urinalysis, establishing a positive line of communication for both this concern and future issues; and

(iii) the opportunity to have the client’s written clinical protocol for urine PCR testing validated by an independent review organization to establish clear coverage parameters, which the Payer agreed to follow for all future urine PCR testing claims, thus enabling our client to resume urine PCR testing and significantly reducing the risk of future claim denials and/or clawbacks of reimbursements.

The global resolution of this matter was an important financial and precedential win for the Group that could only have been accomplished with an out-of-the box approach. The outcome was also a win for the Payer, as a clear agreement on coverage parameters ultimately improves utilization and saves money. Broadly speaking, other providers who may have overutilized urine PCR testing will be more disciplined in ordering it, and providers who may have underutilized urine PCR testing out of fear of future audits and clawbacks will be more comfortable ordering the test for patients who will most benefit from it. In some cases, the test results inform treatment decisions and impact outcomes, which is of critical importance to both patients and payers. A result that enables the provider to prescribe a more precisely targeted antibiotic may prevent the life-threatening and expensive morbidities associated with recurrent urinary tract infections, such as kidney failure and/or sepsis.

Urology specialty providers are well advised to review each payer’s standards and policies pertaining to urine PCR testing and should consider challenging standards and policies that are not based on reliable clinical data and/or not in the best interest of patients. Practices that are not already facing denials and/or clawbacks of urine PCR testing reimbursements are at risk of experiencing these actions by payers in the future. Practices should mount a robust appeal to any denial of urine PCR testing claims or clawbacks of reimbursements and, when possible, initiate a proactive dialogue with the payer to establish reasonable conditions for future urine PCR claims. Payers count on stretched-thin providers having neither the time nor the patience to fight back, but passively accepting a payer’s determination deprives patients of the potentially significant benefits of the test and causes unnecessary financial hardship to the specialists who rely on urine PCR test results to inform treatment decisions.

Frier Levitt is a national boutique law firm dedicated to health care and the life sciences, with offices in northern New Jersey and New York City’s Financial District. www.frierlevitt.com. Daniel B. Frier, Esq., as co-founder of Frier Levitt and the chair of the firm’s Healthcare Group, has built a strong reputation for his knowledge representing healthcare organizations in transactional, regulatory and corporate matters. Theresa M. DiGuglielmo, Esq., is senior counsel to Frier Levitt’s Healthcare Department. Nicole M. DeWitt, Esq., an associate in Frier Levitt’s Healthcare Department, advises clients on contractual and regulatory compliance matters, while anticipating their long-term needs in the event of a future dispute.