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At ASM Microbe, Stakeholders Discuss Reimbursement Issues for Multiplex Infectious Disease Tests

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SAN FRANCISCO (GenomeWeb) – Data demonstrating better patient outcomes are the key missing piece needed in order for multiplex infectious disease tests to be covered by Medicare, according to stakeholders who presented at the American Society for Microbiology's annual Microbe meeting here on Sunday.

In a presentation, Paul Gerrard, medical director at Palmetto GBA and the MolDx director of clinical science, explained the Medicare administrative contractor's decision last year to deny coverage of large respiratory panels. Gerrard said that diagnostic tests had to "change patient management in a way that improves patient outcomes," and that if a test doesn't hit that bar, then it doesn't meet the "reasonable and necessary" requirement for Medicare to cover it.

Gerrard noted that when Palmetto was evaluating multiplex infectious disease tests, and, in particular, the large panels for respiratory viruses, "the evidence we became concerned with was not the ability to detect pathogens but the ability to detect pathogens and then do something actionable with that information that improved patient outcomes."

For instance, he said, while some test developers have argued that diagnosing a virus in a patient can help avoid the use of antibiotics or can enable clinicians to decide to stop the use of antibiotics in that patient, there isn't data that shows that improves outcomes for that patient. In fact, he said, patients may be coinfected with both a viral and bacterial pathogen. Professional societies have also not weighed in to say that that "the presence of a virus can be used to avoid treatment with antibiotics," he said.

However, during a subsequent question and answer session, several attendees questioned this reasoning. For instance, one attendee said that rapid viral diagnostics are an integral part of antimicrobial stewardship programs, and so the decision by Medicare to not cover multiplex tests for respiratory viruses conflicted with goals set by the US Department of Health and Human Services toward antimicrobial stewardship and reducing the use of unnecessary antibiotics.

Nonetheless, Gerrard said that although while reducing the inappropriate use of antibiotics is important, the data and published peer-reviewed studies have not shown that reducing the use of antibiotics in patients who have been found to test positive via a multiplex respiratory viral panel do better when antibiotics are stopped or reduced. However, he said, that's simply because the data doesn't follow up with patients long enough to show either benefit or harm.

"In many cases, the longitudinal follow up is just at the point of physician decision making," Gerrard said. "Whether that decision making was to the benefit of the patient, is unknown."

Gerrard added that Palmetto would consider covering such tests if there were professional guidelines suggesting that they were appropriate to be used in patient management, but those don't yet exist.

Another attendee questioned why Palmetto didn't take into consideration the potential benefit not only to the specific patient receiving the test, but to other Medicare beneficiaries in a long-term care facility, for instance, who could benefit from such rapid multiplex tests, since they could enable infection control measures to be implemented. Gerrard said that such considerations were not Palmetto's purview but should be addressed by public health departments.

Stephanie Ibbotson, director of market access and reimbursement affairs at Luminex, said that the Palmetto LCD decision on multiplex testing spurred Luminex to rethink how the firm develops tests.

"For a long time, 'the bigger the better' was the mentality," she said during a presentation at ASM Microbe. She noted that previously Luminex would design tests based on feedback from its clinical lab customers, which prioritized assay performance as well as broad coverage of targets. But, those priorities were at complete odds with what payors value, Ibbotson said, which is clinical utility data and evidence that testing changes treatment and patient outcomes.

Now, she said, Luminex takes the payor perspective into consideration as well. And in an attempt to balance the opposing needs of the two stakeholders, she said that Luminex has sought to develop a more flexible model where testing can be done depending on a patient's risk category. A low-risk outpatient may need a different test than a high-risk inpatient, for instance.

Ibbotson said that in the future it will be important for clinical labs to understand their payor mix and how that impacts their business. For instance, she said while the Palmetto decision on multiplex panel tests has caused some consternation among clinical labs that had been offering such tests, other payors do, in fact, cover them. So, depending on the clinical lab's payor mix, the impact of the MolDx coverage decision will vary, she said.

Frederick Nolte, director of clinical laboratories at the Medical University of South Carolina, discussed his lab's experience using BioFire's multiplex respiratory panel and the impact of the Palmetto decision. He noted that about one-third of the lab's patient population is covered by Medicare, Medicaid, and private insurance each.

Following the issuance of the LCD, he said, there was some confusion about how to code for testing. The laboratory worked with its local Medicare contractor, private insurers, and its own billing and compliance staff to ensure that the lab's coding follows the current recommendations and requirements.

Prior to the LCD, Nolte said that the lab used CPT codes that totaled around $644. After the LCD, he said that following a discussion with Palmetto, the lab determined that while it could still run the BioFire expanded panel, it could only bill for the three to five targets that were covered, so CPT codes dropped to $288.

Going forward, Gerrard, Ibottson, and Nolte all noted that it will be important for researchers, test developers, and clinical labs to work together to ensure that the appropriate clinical utility studies are done that include outcomes data. In addition, reimbursement will likely continue to be a challenge as technology advances beyond multiplex PCR testing. Metagenomic sequencing, for instance, is starting to be implemented for clinical infectious disease testing for certain acutely ill patients.

Gerrard acknowledged that it occurred to him at this meeting that metagenomics is a "problem we'll have to deal with in the not too distant future."