Advocacy Update

August 16, 2022

In this Issue:

FDA Gives Update on Monkeypox Testing and LDTs

During an open call with laboratories on August 15, officials with the Food and Drug Administration (FDA) said laboratory-developed tests (LDTs) for monkeypox disease are under enforcement discretion and can be developed without notifying the FDA.

The CAP attended the Laboratory Outreach Communication System call managed by the Centers for Disease Control and Prevention (CDC). The clarification on LDTs follows the United States’ declaration of monkeypox as a public health emergency.

FDA Director of the Office of In Vitro Diagnostics Timothy Stenzel, MD, PhD, said the FDA is considering what processes and policies would be needed if the agency issued an emergency declaration. The FDA would release guidance documents similar to those released during the coronavirus pandemic. It would have a template for test submission requiring 30 positive and negative samples. However, due to the difficulty of obtaining samples, laboratories and manufacturers could use contrived specimens for validation.

If an LDT is currently on the market before an emergency use authorization (EUA) is issued, the LDT would be allowed to remain on the market as the FDA implements its monkeypox EUA testing guidance.

The CAP will monitor FDA activities and notify its members if the agency takes further action.

Previously, the Centers for Disease Control and Prevention (CDC) had released guidance on reporting test results and specimen collection. The government has worked to overcome issues with specimen collection as laboratories have reported enough capacity to test for the disease.

During the CDC call, officials said the US leads the world with more than 11,000 monkeypox cases. Along with reviewing guidance on specimen collection, the CDC provided resources on validation materials for the disease developed by the National Institute for Standards and Technology and BEI Resources.

CAP Asks Congress to Stop Clinical Laboratory Payment Cuts

The CAP and members of a laboratory coalition strongly urged congressional leaders to protect payment for clinical laboratory services by supporting the bipartisan and bicameral Saving Access to Laboratory Services Act (SALSA). The SALSA legislation would address the CAP’s concerns with clinical laboratory payment rates because of PAMA. Citing adverse impacts on laboratories and patients, the CAP advocates for improvements to how the Centers for Medicare & Medicaid (CMS) collects data from laboratories and stops next year’s 15% payment cut to more than 800 clinical laboratory tests. Absent congressional intervention, laboratories face a 15% cut in January of 2023. This will limit payment reductions in 2023 to 0%; to 2.5 in 2024, and for 2025 and each subsequent year, any reductions would be limited to 5%.

The CAP joined in this effort to urge Congress to act on PAMA reform to protect patient access to laboratory services.

In the August 15 letter, the coalition urged congressional leadership to pass the SALSA act as a “permanent solution that would set Medicare reimbursement for laboratory services on a sustainable path forward. SALSA will give the CMS new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services where previous data collection was inadequate. In addition, the bill ensures true private market rates are included, provides a much-needed reduction in reporting burden, and protects laboratories and Medicare from dramatic rate increases or decreases with a gradual phase-in approach going forward.”

The CAP has long expressed concern about PAMA’s burdensome reporting requirements and the CMS’ failure to include in payment reporting such a large portion of the laboratory market, resulting in a skewing of the PAMA payment rates. In the last three years, Congress has delayed clinical laboratory reporting periods and delayed cuts to Medicare clinical laboratory fee schedule (CLFS) services to maintain access to laboratory services for patients. However, without a sustainable solution, laboratories face CLFS cuts up to 15% in January of 2023.

Pathologists Who Rely on MIPS Facility-based Scores Must Urgently Find an Alternative for 2022

In the final 2023 Inpatient Prospective Payment System (IPPS) /Long-Term Care Hospital Prospective Payment System (LTCH PPS) regulation, the CMS phased out several measures in the Hospital Value-Based Purchasing (VBP) Program due to the effect of COVID-19 on measure performance. Therefore, the CMS will not calculate the MIPS facility-based scores for the 2022 MIPS performance year.

The CMS understands that calculating a total performance score in the Hospital VBP Program for hospitals using only data from the remaining measures would not result in a fair national comparison. Therefore, the CMS will not calculate a 2023 total performance score under the Hospital VBP Program for any hospital affecting the MIPS facility-based score.

The CMS will not calculate the MIPS facility-based scores for the 2022 MIPS performance year because the 2023 total performance score from the Hospital VBP Program won’t be available. Facility-based clinicians and groups must collect and submit MIPS quality measures to receive a score other than zero for the quality performance category.

If a pathology practice has used facility-based scoring, the practice will need a different mechanism to submit MIPS. Pathologists and their practices can check their MIPS eligibility.

Facility-based clinicians and groups without available and applicable measures can request performance category reweighting by submitting a 2022 MIPS Extreme and Uncontrollable Circumstances Exception application. For more information, please visit the CMS Quality Payment Program or contact with specific questions.

New Webinar Date: CAP Leaders Discuss LDT Oversight Updates on August 22

CAP President Emily E. Volk and Council on Government and Professional Affairs Chair Jonathan Myles will provide an update on the latest laboratory-developed testing oversight legislation during a member webinar.

On August 22 at 2PM ET/1 PM CT, CAP leaders will provide an update on the latest on congressional efforts to enact legislation for a new comprehensive regulatory framework for clinical laboratory tests, including laboratory-developed tests (LDTs) and the Verifying Accurate Leading-edge IVCT Development (VALID) Act.

Register for the webinar

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