Advocacy Update

• New CAP Webinar Series: Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory
• CMS Incorporates CAP Recommendations in Expedited Medicare Coverage of Some Breakthrough Medical Devices
• CDC Issues Alert to Immediately Discard Affected BD BACTEC MGIT 960 PZA Kits
• CDC Warns of Increased Oropouche Virus Activity and Associated Risk to Travelers

The CAP is launching a six-part webinar series to help the pathology and laboratory community understand and prepare for the Food and Drug Administration (FDA) oversight rules for laboratory-developed tests. The webinar series begins on September 18 and will focus on the FDA risk classification system.

Last April, the FDA released its regulation on the oversight of LDTs, which the CAP opposes and is advocating to stop from going into effect. Laboratories and pathologists—many having never worked with the FDA—now have questions and concerns as they face implementation of the LDT regulation’s first phase in May 2025.

The first webinar in our series on September 18, Noon-1 PM CT, will help laboratories understand FDA risk classification systems. We will discuss differences in classifications used by the FDA and CLIA, requirements under the FDA risk categories, and what activities the FDA includes in its general and special controls. Our experts will also discuss examples of common tests and how the FDA requirements will apply to them.

Whether you attend live or watch the on-demand recording at a time more convenient for you, register today for the first event in the series and save the dates for the upcoming webinars through July 2025.

Register now!

Future webinar topics:

• November 7, 2024, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement

• January 9, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Corrective Action and Removal Reporting

• March 20, 2025, Noon–1:00 PM CT, Ready Your Laboratory for the FDA’s Stage 1: Rules for Quality System Complaint Processes

• May 8, 2025, Noon–1:00 PM CT, How Enforcement Discretion Categories & Modification Rules Apply to Your LDTs

• July 10, 2025, Noon–1:00 PM CT, Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency

On August 7, the Centers for Medicare & Medicaid Services (CMS) issued a final notice on the Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite national coverage of some FDA-designated breakthrough devices. In August 2023, the CAP offered several recommendations on the proposed TCET pathway. The final notice implemented these recommendations from the CAP:

• Ensure diagnostic tests are included in the TCET pathway. In the final notice, the CMS decided laboratory diagnostic tests will continue to be made by Medicare Administrative Contractors (MAC) through existing local coverage pathways.
• Increased transparency of unspecified criteria used by the CMS to prioritize innovative technologies and transparency of pathway timelines. The CMS agreed to provide this information on a public dashboard that will be updated regularly including quarterly (instead of annual) reviews of the TCET nominations, pre-emptive endpoint reviews, and convening MEDCAC panels to examine the data that has been collected.
• Ensure the protection of a developer or manufacturer’s proprietary information about a device that it has developed if a manufacturer withdraws from the process during the premarket stage. CMS said it will not divulge the identity of specific manufacturers or devices in the TCET pathway prior to the opening of an NCD. However, the CMS said it is important to provide transparency on devices that are accepted into the pathway.

The pathway uses existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage for devices where the evidence is promising but does not yet satisfy the reasonable and necessary standard for Medicare coverage. A breakthrough device is defined as a novel medical device that has the potential to provide more effective treatment or diagnosis, and meets the criteria outlined under the 21st Century Cures Act. On average, it takes approximately five years after a device is authorized by the FDA to receive national Medicare coverage, while TCET coverage may be provided within six months of FDA authorization.

Manufacturers interested in the TCET pathway need to notify the CMS of their interest in TCET and may self-nominate to participle in the pathway. The CMS will soon release the proposed factors it will use to prioritize TCET nominations. The public will have an opportunity to provide comments on the CMS’ proposed prioritization factors. In the meantime, the CMS will prioritize TCET candidates based on the magnitude of the potential impact on the Medicare program and its beneficiaries and staffing resources.

On August 16, the Centers for Disease Control and Prevention (CDC) sent out an alert regarding the removal of affected BD BACTEC™ MGIT™ 960 PZA Kits. The kits may intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. The current list of affected lots can be found here.

Laboratories should immediately inspect their inventory and destroy affected product subject to the recall following their institution’s process of destruction. There are no recommendations for retesting or reviewing previous patient test results.

BD recall related questions can be sent to: BDRC12@bd.com.

On August 16, the CDC issued a health advisory to notify clinicians and public health authorities of an increase in Oropouche virus, a disease transmitted by small flying insects and mosquitoes in the Americas region, originating from endemic areas in the Amazon basin and new areas in South America and the Caribbean. Between January 1 and August 1, 2024, health agencies reported more than 8,000 cases of Oropouche virus disease, including two deaths and five cases of vertical transmission associated with fetal death or congenital abnormalities. In the United States and Europe in 2024, travel-associated cases have been identified in travelers returning from Cuba and Brazil.

Approximately 60% of people infected with Oropouche virus become symptomatic. The incubation period is typically 3–10 days. Initial clinical presentation is similar to diseases caused by dengue, Zika, and chikungunya viruses, with acute onset of fever, chills, headache, myalgia, and arthralgia. Other symptoms can include retroorbital (eye) pain, photophobia (light sensitivity), nausea, vomiting, diarrhea, fatigue, maculopapular rash, conjunctival injection, and abdominal pain.

Clinical laboratory findings can include lymphopenia and leukopenia, elevated C-reactive protein (CRP), and slightly elevated liver enzymes. Initial symptoms typically resolve after a few days, but a high proportion (about 70%) experience recurrent symptoms days to weeks after resolution of their initial illness. Read more about Oropouche Virus from the CDC.