LCD addresses NAAT panels for infectious disease testing

Jonathan Rubenstein, MD

Although Medicare is a federal program, the 50 states, along with 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 policy development for payment protocols if the policies do not violate national Medicare directives. Each MAC is also charged with responsibly guarding the beneficiaries within the Medicare program. The Centers for Medicare & Medicaid Services has an interactive Medicare Jurisdiction Map noting state and MAC with contact information on the Medicare website: https://go.cms.gov/3xXOyg6.

Mark Painter

Over the years, Medicare has encouraged the MACs to develop policies based on location with input from physicians in the state working in conjunction with state medical organizations. The system has evolved. It is our understanding that MACs are encouraged to communicate with one another to provide some consistency across jurisdictions as they develop payment policies; however, they are not required to mimic payment policies developed for other jurisdictions. Medicare requires all MACs to adhere to updated processes for developing and releasing payment policy and to participate in supporting a centralized policy location tool; Medicare centrally continues to develop national policies when deemed appropriate.

Under current Medicare protocol, carriers are allowed to develop local coverage determinations (LCDs) based on current medical practice and necessity to provide general coverage guidance for services provided to Medicare beneficiaries. Each LCD must be developed with active stakeholder input and after being issued as a proposed policy with comment period before it is finalized and adopted. The MAC is required to respond to all comments submitted during the designated review period. After consideration of the comments, the MAC can revise and publish the policy.

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

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

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

Each MAC has also issued an associated LCA with coding instructions and limitations on coverage. All states affected by the LCD and LCA participate in the MolDX program administered by Palmetto GBA. The LCA includes coverage and coding instructions for the use of these greater than 5 tests per specimen (often referred to as PCR testing) for urinary tract infections (UTI) and sexually transmitted infections.

In summary, each laboratory within these jurisdictions that performs NAAT panels for infectious diseases will need to apply for a Z code through the MolDX program. More specifically, each lab will need to apply for a unique Z code for each panel of tests being ordered/performed.

For example, if a urology group has 3 separate test panels for UTIs, the group will be required to obtain its own unique Z code for each test panel. For those groups using a reference lab for such panels, the lab will need to apply for a Z code and request sharing. If a group has multiple lab locations and each lab is performing the same test, only 1 application is required for the entity to which the Clinical Laboratory Improvement Amendments are assigned.

Once the application is submitted, MolDX will perform a technical assessment prior to issuing the Z code. After the technical assessment is completed and the Z code is issued, the lab will receive notification, Z code, and billing instructions. Billing for a panel test is usually cross-walked to a CPT type code and not reported with the Z code issued. The following link will provide additional information on the process: https://bit.ly/3rVAf7U.

It should be noted that within the LCAs for each of the MACs there is a reference—either in the article that became effective April 17, 2022, or in the comments in response to requests 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 assessment is complete and the Z code is issued, nor will the system allow for retroactive billing of these tests.

The remaining MACs (First Coast Service Options, National Government Services, and Novitas Solutions) do not participate in the MolDX program and Z codes are therefore not required. However, these MACs can implement these LCDs or similar ones if they choose to pursue this in the future. Instead of Z codes for these states, panel tests will likely be reported under Proprietary Laboratory Analyses (PLA) Current Procedural Terminology (CPT) codes. PLA codes can be obtained from CPT and are alphanumeric. Obtaining a PLA code is not as time consuming 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 be assigned a grouped service code for accurate reporting and adjudication. 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 one’s location, the response by the MACs to this issue indicates that billing 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 diagnosis and subsequent treatment of UTIs and other urologic problems. Most groups understand well the requirement, regardless of published billing protocols, that all claims submitted for payment must be medically reasonable and necessary. Number of tests ordered/performed and presenting complaint/condition of the patient must be accurately noted in the medical record. Many practices have also developed clinical guidelines for the appropriate use of PCR testing. As more published peer-reviewed articles address these tests, we would expect Medicare and other payers to adapt payment policy and coding guidance to any new clinical findings.

Send coding and reimbursement questions to Rubenstein and Painter c/o Urology Times®, at UTeditors@mjhlifesciences.com.

Questions of general interest will be chosen 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 it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.