Response to Comments: Respiratory Pathogen Panel Testing

Comments were submitted on behalf of an industry stakeholder pointing out that while the LCD focuses on Medicare Part B, the contractor information at the start of the LCD includes both Part A and Part B. The commenter requests that the final LCD only include the Part B contractor numbers to ensure clarity and avoid any unintended billing complications. Additionally, the commenter requested that a comment be added to the billing and coding article to indicate that the LCD is not applicable to providers submitting claims on an institutional claim form. The commenters also suggested that creating an upper limit on panel size of 5 pathogens is an arbitrary coverage decision and not supported by evidence citing the Medicare Program Integrity Manual, Chapter 13. The commenters have requested that the upper limit be removed. Clarification in the language to clarify the clinical scenarios for coverage was requested. The commenters agree that testing should provide actionable information to the clinician and they have suggested clarifying the first criterion to focus on management of the patient rather than timeliness. Further, the commenters suggest the language in the second criterion for coverage be changed to reflect that the clinician plans to guide management with the intent to improve outcomes based on the test results. Lastly, the commenters recommended providing some examples of circumstances in which respiratory testing may be considered medically reasonable and necessary.

Thank you for your comment, as noted by the language in the LCD, this LCD is only pertinent to Medicare Part B. Upon finalization of the LCD we will ensure that only the Part B contractor numbers display. Clarification will be added to the billing and coding article to make it clear that this LCD does not apply to Part A. Regarding the upper limit of pathogens, the overall studies suggest that other than testing for influenza and the importance of identifying COVID-19, testing for multiple pathogens has not proven to impact clinical decision making resulting in improved patient outcomes in the outpatient setting. The commenter provided no evidence to the contrary. Based on the studies we believe that testing for more than 5 pathogens in the outpatient setting would be rare and as such these rare situations should be handled through the redetermination process. We appreciate the recommended language clarification for the coverage criterions and have provided clarification consistent with the evidence and the goal of improved health outcomes in the Medicare population. We believe including examples of respiratory testing that would be considered medically reasonable and necessary are more a function of clinical guidelines and provider decision making in that specific circumstance, and if included could be interpreted as confusing or limiting. We believe clinicians are the best ones to judge when respiratory testing is needed in a given patient, based on current guidelines which are consistent with this evidence review.

Comments were received from an industry stakeholder explaining the BioFire respiratory panel targets and usefulness and requesting that the panel be covered. The commenter indicated that a comprehensive panel has the potential to increase the likelihood of a definitive diagnosis which can influence appropriate medical management of a patient. It is felt that at least 9 pathogens are necessary to detect for public health and isolation protocols. Early and accurate diagnosis of SARS-CoV-2 is important for proper isolation, contact tracing and other measures to slow the spread of the virus. A negative result for SARS-CoV-2 in conjunction with a positive result for a less serious virus allows patients to avoid isolation and resume their essential activities. The commenter pointed out that the Centers for Medicare & Medicaid Services (CMS) has stated that testing for differential COVID-19 diagnoses should be a covered service. It was noted that the benefits of receiving a positive result for a respiratory pathogen include appropriate prescribing or withholding of antimicrobials, potential avoidance of follow-up tests due to a negative result, appropriate isolation or avoidance of isolation and physician and patient satisfaction that appropriate action was taken. The commenter maintains that statistically speaking the greater the number of targets included on a diagnostic panel the greater the likelihood of receiving a definitive diagnosis to guide therapy. Based on this, several associations have voiced their support for universal coverage of comprehensive respiratory panels and have petitioned this view to CMS. The comment went on to point out that the proposed LCD states “general consensus from the CAC panel is that there is accuracy and reliability in these respiratory pathogen panels and that the results of this testing may improve patient health outcomes” and this statement is at odds with a more limited coverage. A lengthy list of references was noted in the comment, but no full-text articles were submitted for review.

Thank you for the in depth comment. The overall studies suggest that other than testing for influenza and the importance of identifying COVID-19, testing for multiple pathogens has not proven to impact clinical decision making resulting in improved patient outcomes in the outpatient setting. We agree that CMS has advocated for coverage of COVID-19 testing, but we maintain that testing for multiple pathogens in the outpatient setting has not yet demonstrated an impact on clinical decision making. While the proposed LCD states “general consensus from the CAC panel is that there is accuracy and reliability in these respiratory pathogen panels and that the results of this testing may improve patient health outcomes,” it goes on to state "The CAC panel also noted that there is a gap in the literature when it comes to patient health outcomes related to the results and how it affects patient treatment and/or management especially with pathogens of lower prevalence that some of the respiratory pathogen panels include." We reviewed the full text articles that were submitted along with the comments, and determined there was no new evidence in form of clinical trials, guidelines, etc. to support that multiple pathogen testing in the outpatient setting would impact clinical decision making resulting in improved patient outcomes. The reconsideration process as outlined on our website may be used to submit any new full-text articles/evidence once the LCD becomes effective.

The Association for Molecular Pathology (AMP) and the College of American Pathologists (CAP) urged “NGS to postpone implementing its proposed LCD for Respiratory Pathogen Panel Testing pending the completion of Palmetto’s proposed LCD so that NGS may consider further evidence and information relevant to larger panels for use within the framework of its own coverage policy for infectious disease testing in the outpatient setting.”

Thank you for your comment. The evidence review did examine all outpatient evidence including immunocompromised patients and the LCD analysis came to this conclusion: "In the immunocompromised, where concerns are great for poor outcomes, the data comes primarily from the inpatient setting. In the inpatient setting, results are inconsistent."^23,24 To further help clinical decision-making, Ramirez 2020 addresses initial treatment of the immunocompromised, as defined in the document, and recommends a low threshold for hospitalization, with the suggestion of a comprehensive individualized microbiological work-up. The document does not address outpatient microbiological studies. We encourage providers with any new literature that may support the use of more than 5 pathogens in the outpatient setting to submit the full-text literature via the reconsideration process outlined on our website once the LCD has become effective. No changes will be made to the LCD or article at this time.

One individual commented that studies have demonstrated a positive impact on multiplex respiratory panels (>5 analytes) in decreasing unnecessary antibiotic use.

We agree with the presenter and Brittain-Long 2011, BMC Medicine, that rapid results play a great role in outcomes of patients and have reflected so in our policy. We however disagree with the conclusion of the presenter that because the panel used in papers referenced was >5, then that is what is needed. Echavaria et al in the discussion referred to RSV and Influenza detection making the most difference in patient outcomes and these are included in panels ≤5 which we cover in this policy. No changes will be made to the LCD or article at this time.