Responding to Medicare Audits of PCR Testing for UTIs in 2026

VI. Overview of Government Enforcement of PCR Testing for Urinary Tract Infections Claims:

From an enforcement standpoint, there is a wide range of CMS contractors and law enforcement groups that may conduct audits and investigations of your UTI laboratory testing claims. While most reviews of PCR testing for UTIs claims are handled as administrative audits, should the facts in a case warrant more serious review, the government may pursue civil penalties or criminal sanctions. These audit and enforcement options are discussed in more detail below.

A. Administrative Audits.

CMS has engaged a variety of contractors to review and audit Medicare Part B claims. While some of these CMS contractors are primarily involved in the processing of a provider’s claims, several others have been assigned a variety of program integrity functions. Unified Program Integrity Contractors (UPICs)^[38] are the primary program integrity contractors likely to audit your UTI testing claims. The primary denial reasons cited by UPICs when denying UTI testing claims have included the following:

• Lack of Medical Necessity. While your CMS contractor may word the denial differently, we are regularly seeing UPICs deny PCR urinary tract infection testing claims based on lack of medical necessity and stating:
  

  “The records failed to support how the lab tests would impact the treatment or management of the beneficiary’s medical conditions, and how they met, and did not exceed, the beneficiary’s medical needs.”

  To establish medical necessity for Medicare coverage, the UPIC has been looking for documentation in the patient’s Treatment Plan or Plan of Care that will tie the patient’s clinical condition to the need for UTI testing. A provider must clearly document that the test is reasonable and necessary for diagnosing or managing the patient’s specific clinical condition. This includes showing that the patient’s symptoms, risk factors, and/or prior diagnostic failures justify the use of PCR testing over standard methods (such as SUC testing). Additionally, the test must meet technical and administrative requirements, such as registration with the MolDX program (where applicable), and all claims must be supported by detailed medical records.

• Improper Billing and Coding Practices. There are a wide variety of ways that UTI testing claims can be improperly billed or coded. One of the more common improper coding practices cited by UPICs has been the incorrect use of Modifier 59. Sample denial language cited by a UPIC might read:
  

  “Most of the claim lines reviewed had modifier 59 appended to the claims lines to indicate that the services billed were distinct or independent from the other services billed on the same date, which was not supported in the documentation.”

  Unfortunately, Modifier 59 has a long history of being incorrectly billed by Medicare providers.^[39] Modifier 59 is only to be used when a provider is billing for a distinct procedural service that is separate from other services performed on the same day. Earlier this year, CMS issued detailed guidance on the use of Modifier 59, titled “Proper Use of Modifiers 59, XE, XP, XS & XU.”^[40]

  In the UTI testing context, a provider would need to document that urine tests performed on the same day involved one or more of the following: (1) Resulted from different patient encounters, (2) Were based on separate urine specimens, (3) Were collected at different collection sites, (4) Tests were performed at separate times on the same day, or (5) Were related to a different patient complaint or injury. Ultimately, a provider needs to document that the two UTI testing codes billed may look like they should be bundled, but are really separate and distinct specimens that qualify for payment.

• Excessive Testing. UPICs have regularly denied UTI testing claims on the basis that extensive PCR testing was unnecessary. Instead, the CMS contractor will argue that a standard urinalysis with culture and sensitivity (CPT Code 81001 or CPT Code 81003) would have been sufficient to meet the patient’s needs. Sample denial language cited by a UPIC might read:
  

  “Documentation did not provide a reason why extensive testing was needed and why a urinalysis with culture and sensitivity was insufficient. The notes did not support that the tests billed met, but did not exceed, the beneficiary’s medical need.”

• Unsupported or Incorrect Diagnosis Code. When a UPIC reviews your UTI testing claims, it will carefully assess the specific ICD-10 codes^[41] listed on the CMS Form 1500 to determine whether the codes cited are either codes for symptoms associated with a urinary tract infection or are associated with confirmed UTIs. Sample denial language cited by a UPIC might read:
  

  “The diagnosis is inconsistent with the procedure. This indicates a mismatch between the UTI testing CPT code and the submitted ICD-10 code(s) based on payer policy.”

UPICs have been especially critical in claims audits where the diagnosis code cited is “N39.0 Urinary tract infection, site not specified.” When making an initial diagnosis before completing additional testing, a provider may not be able to provide this level of specificity. However, if this information is known, a provider should document the specific location within the urinary system (kidneys, ureters, bladder, urethra) where the infection is located.

B. Collateral Consequences of Administrative Audits.

• Revocation of Billing Privileges. Nevertheless, CMS is now routinely including “revocation” language in UPIC audit decision letters to providers. For example, one recent UPIC decision letter stated the following:
  

  “In addition, we remind you that our regulation at 42 CFR § 424.535 authorizes us to revoke Medicare billing privileges under certain conditions. In particular, we note that per 42 CFR § 424.535(a)(8)(ii),^[42] CMS has the authority to revoke a currently enrolled provider’s or supplier’s Medicare billing privileges if CMS determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements.”

  In recent years, CMS has been actively revoking providers’ Medicare billing privileges based on 42 CFR § 424.535(a)(8)(ii). This subsection of the Medicare revocation regulation is quite broad and is frequently cited by CMS program integrity contractors when a significant portion of the claims reviewed have been denied. From a practical standpoint, when CMS revokes a provider’s billing privileges, it is often for a period of 10 years. Depending on a provider’s payor mix, this may cause a provider to file for bankruptcy.

• UPIC Referrals to Law Enforcement. Although most UPIC audits result in administrative overpayment assessments, UPIC audits can result in referrals to the HHS, Office of Inspector General (OIG), or to the U.S. Department of Justice (DOJ) for review and prosecution. As discussed in the Medicare Program Integrity Manual:
  

  “ . . . If it is determined an investigation should be referred to LE, the UPIC shall refer the matter to the designated OIG/OI Special Agents-in-Charge (SAC), Department of Justice Assistant United States Trial Attorneys, or other parties identified during the case coordination discussion.” (Emphasis added).^[43]

C. Civil False Claims Act Liability.

• Washington. In this case, an urgent care clinic with multiple locations was alleged to have violated the False Claims Act. According to the settlement agreement, the defendant clinic was alleged to have fraudulently billed for PCR respiratory and urinary tract infection panel testing. These panel tests were a predetermined group of medical tests used to test for multiple pathogens from a single sample obtained from a patient. The government alleged that instead of billing for a single panel test, the defendant urgent care clinic improperly “unbundled” the panel test and billed for each individual test comprising the panel. This resulted in overbilling to Medicare and Medicaid programs. In addition, the State of Washington alleged that the defendant urgent care company improperly billed for panel tests that were more expensive and not medically necessary for individual patients. To resolve the False Claims Act allegations asserted, the defendant urgent care company agreed to pay more than $2.8 million.
• Missouri. In this case, a Missouri-based laboratory and its three owners (collectively referred to as “defendants”) were alleged to have violated the False Claims Act by submitting or causing the submission of claims to Medicare for lab tests that were not ordered by health care providers and were not medically necessary. More specifically, the government alleged that the defendants submitted claims for PCR urinary tract infection panel testing that was not ordered by the patients’ treating physicians. For example, when a treating physician ordered a basic urinalysis with culture and sensitivity, the laboratory was alleged to have performed and billed for a more complex (and more expensive) PCR urinary tract infection panel of tests. The government also alleged that the requisition forms used by the laboratory were structured in a way that did not allow physicians to opt out of the UTI PCR tests. To resolve these False Claims Act allegations, the defendants agreed to pay more than $13 million to the United States.
• Exclusion from Participation in Federal Health Care Programs. When settling a False Claims Act, the OIG may elect to exercise its permissive exclusion authority and exclude individuals and/or entities associated with the settlement. “Exclusion” is the most severe administrative sanction that can be imposed on a provider.
• New Developments on the False Claims Act Front. On December 1, 2025, the U.S. Court of Appeals for the First Circuit issued a favorable decision in United States ex rel. Omni Healthcare v. MD Labs,^[44] a significant False Claims Act case involving the alleged improper billing of PCR urinary tract infection testing. The appeals court ruled that laboratories may generally rely on a physician’s order as evidence that a test is “reasonable and necessary” for Medicare purposes. Laboratories are not expected to second-guess the medical judgment of licensed providers, unless there is evidence of fraud or improper conduct by the laboratory itself. This decision sets a strong precedent in the First Circuit -- diagnostic laboratories are protected from False Claims Act liability when acting in good faith on physician orders, unless there is clear evidence of knowledge or reckless disregard of medical necessity. However, this is not blanket immunity. Laboratories must still avoid submitting claims for tests they know to be unnecessary.

D. Criminal Liability.

Although we were unable to identify any criminal prosecutions based exclusively on PCR testing for urinary tract infection claims, there have been a number of cases where the government has alleged that ordering providers and associated sales representatives working for laboratories have violated the Federal Anti-Kickback Statute^[45] when promoting the services of a given laboratory. While the Anti-Kickback Statute is a criminal statute, it was amended as part of the Affordable Care Act to permit kickback violations to also be pursued as violations under the civil False Claims Act.