LCD Addresses NAAT Panels for Infectious Disease Testing

Although Medicare is a federal program, the 50 states, plus the District of Columbia and Puerto Rico, are divided into 12 jurisdictions. Medicare then contracts with private companies to administer the program for those jurisdictions. These private contractors are called Medicare Administrative Contractors (MAC) or Carriers. Each MAC has flexibility in developing policies for payment protocols if the policies do not violate national Medicare guidelines. Each MAC is also responsible for responsibly protecting Medicare beneficiaries. The Centers for Medicare & Medicaid Services has an interactive map of Medicare jurisdictions showing state and MAC with contact information on the Medicare website:

Over the years, Medicare has encouraged MACs to develop location-based policies with input from state physicians working in conjunction with state medical organizations. The system has evolved. We understand that MACs are encouraged to communicate with each other to ensure consistency across jurisdictions when developing payment policies; however, they are not required to mimic payment policies developed for other jurisdictions. Medicare requires all MACs to adhere to updated processes to develop and publish a payment policy and participate in supporting a centralized policy locator tool; Medicare continues to develop national policies at the central level when deemed appropriate.

Under current Medicare protocol, carriers are permitted to develop Local Coverage Determinations (LCDs) based on current medical practice and the need to provide general coverage guidance for services provided to Medicare beneficiaries. Each LCD should be developed with active stakeholder participation and after being published as a proposed policy with a comment period before being finalized and adopted. MAC is required to respond to all comments submitted during the designated review period. After considering the comments, the MAC may revise and publish the policy.

The coding/billing instructions associated with an LCD are communicated in Local Coverage Articles (LCAs) because the LCD is intended to outlast any possible coding changes that might occur each year. A MAC may issue an ACL without a corresponding LCD to provide encoding direction for services that may not require a full LCD. LCDs and LCAs can be found on the Medicare coverage database and MAC websites.

On April 17, 2022, a Multi-Jurisdiction LCD for Multiplex Nucleic Acid Amplification Testing (NAAT) Panels for Infectious Disease Testing was released. This has not been adopted for all jurisdictions but rather for the following MACs: Wisconsin Physician Services Insurance Corporation; Directors CGS, LLC; Noridian Healthcare Services, LLC; and Palmetto GBA.

The LCD followed the Medicare protocol, with several national meetings with stakeholder participation in 48 states and Puerto Rico. Comments on the LCD originally published in 2021 resulted in an amended LCD based on feedback from stakeholders attending meetings and submitted separately during the designated comment period.

Each MAC also issued an associated ACL with encoding instructions and coverage limitations. All LCD and ACL affected states participate in the MolDX program administered by Palmetto GBA. The ACV includes coverage and coding instructions for using these 5+ tests per sample (often called PCR tests) for urinary tract infections (UTIs) and sexually transmitted infections.

In summary, each laboratory in these jurisdictions that performs infectious disease NAAT panels will need to request a Z code through the MolDX program. More specifically, each laboratory will have to request a unique Z code for each panel of tests ordered/performed.

For example, if a urology group has 3 separate UTI test panels, the group will need to get its own unique Z code for each test panel. For groups using a reference lab for such panels, the lab will need to request a Z code and request sharing. If a group has multiple lab locations and each lab performs the same test, only one request is required for the entity to which the clinical lab enhancement changes are assigned.

Once the application is submitted, MolDX will perform a technical assessment before issuing the Z-code. Once the technical assessment is complete and the Z-code is issued, the lab will receive a notification, Z-code, and billing instructions. Billing for a panel test is usually linked to a CPT type code and is not reported with the Z code issued. The following link will provide additional information on the process:

It should be noted that in the ACLs for each of the MACs, there is a reference – either in the article which came into effect on April 17, 2022, or in the comments in response to inquiries from those within the MAC – that there are no FDA-approved UTI panels. Billing for UTI NAAT (PCR) tests will not be allowed until the technical evaluation is complete and the Z code is issued, nor will the system allow retroactive billing for these tests.

The remaining MACs (First Coast Service Options, National Government Services and Novitas Solutions) do not participate in the MolDX program and therefore Z codes are not required. However, these MACs may implement these LCDs or the like if they choose to pursue this in the future. Instead of the Z codes for these states, panel tests will likely be reported under the Current Procedural Terminology (CPT) codes of Proprietary Laboratory Analysis (PLA). PLA codes can be obtained from CPT and are alphanumeric. Obtaining a PLA code does not take as long as standard CPT code applications. PLA codes are issued quarterly by the American Medical Association. PLA codes were designed to allow specific lab test protocols/panels to assign a bulk service code for accurate reporting and decision. If you practice in a jurisdiction served by one of the MACs that does not participate in the MolDX program and has not issued an LCD, you will not be required to change your current billing practices.

Regardless of location, MACs’ response to this issue indicates that charging for PCR services has been noted as a potential area for abuse. We have spoken with many practices considering and/or implementing this tool for the diagnosis and subsequent treatment of UTIs and other urological issues. Most groups understand the requirement, regardless of published billing protocols, that all claims submitted for payment must be medically reasonable and necessary. The number of tests ordered/performed and the patient’s complaint/condition should be accurately noted in the medical record. Many practices have also developed clinical guidelines for the appropriate use of PCR testing. As more published and peer-reviewed articles discuss these tests, we expect Medicare and other payers to adapt payment policy and coding guidelines to any new clinical findings. .

Send coding and refund questions to Rubenstein and Painter c/o Urology Time®to [email protected]

Questions of general interest will be selected for publication. The information in this column is designed to be authoritative and every effort has been made to ensure its accuracy at the time of writing. However, readers are encouraged to check with their carrier or private payers for updates and confirm that this information complies with their specific rules.

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