Advocacy Update

September 13, 2022

In this Issue:

FDA Requires Emergency Use Authorization for Monkeypox Tests

On September 7, the Food and Drug Administration declared a public emergency requiring clinical laboratory tests for monkeypox to obtain emergency use authorization (EUA) before offering the test clinically. To assist developers in the EUA submission process, the FDA published guidance for monkeypox tests to address the ongoing public health emergency. The guidance describes the FDA’s review priorities for requests for monkeypox tests and what laboratories need to do when developing tests to diagnose the disease. Moreover, the guidance document states that laboratory-developed tests (LDTs) are not required to submit an EUA if these laboratories notify the FDA. The CAP is engaged with the FDA on the new guidance and urges the agency to ensure it takes the necessary steps so laboratories can expeditiously offer and test patients for monkeypox.

What the FDA’s Emergency Declaration on Monkeypox Means for Laboratories

At this time, a CLIA-certified laboratory may develop and perform monkeypox tests that meets the requirements to perform tests of high complexity where:

  • The test uses molecular PCR technology;
  • The test uses lesion swabs;
  • The test has been appropriately validated; and,
  • The laboratory notifies the FDA of validation within five business days of offering the test (or, for currently-offered tests within this scope, notifies the FDA within five business days from the date of the guidance) that it has appropriately validated such test (by email to with a subject line “FDA Notification of Development and Validation of Monkeypox Test”).

The policy does not apply to laboratory-developed tests (LDTs) with home specimen collection or at-home tests or tests using specimen types other than lesion swabs or technologies other than PCR. However, on a case-by-case basis, the FDA would consider if academic medical centers can offer such tests using a different specimen type or a different technology for laboratories directly involved in patient care.

CAP Asks CMS to Finalize Increased Clinical Laboratory Labor Pricing in 2023

The CAP had advocated to increase clinical labor pricing in 2023 and asked the Centers for Medicare & Medicaid Services (CMS) to finalize it in the final regulation. Additionally, the CAP urged the CMS to finalize the prices of certain supplies and equipment, clarify the MIPS Value Pathway requirements, reinstate MIPS bonus points for high-performing physicians and clarify the pathology quality measures for the 2023 Quality Payment Program. The CAP continues to fight for fair reimbursement and reduce reporting burdens for pathologists.

Medicare Physician Fee Schedule

In the September 2 letter, the CAP urged the CMS to finalize clinical labor pricing rates that it spent the last year advocating to correct. The CAP asked the CMS to finalize the increased clinical labor rates, which will be phased in over the next three years. The CAP specifically asked the CMS to finalize the histotechnologist’s labor rate increase which would be greater than 16% of what the CMS previously finalized. Additionally, the CAP requested that the CMS finalize a pricing update of six supplies and two equipment items in the proposed 2023 Medicare Physician Fee Schedule to enhance the accuracy of the costs associated with several pathology services.

Quality Payment Program (QPP)

The CAP appreciated that CMS is limiting changes to the MIPS program but encouraged CMS not to finalize changes to scoring on measures that make it harder for pathologists to reach the scoring threshold. To that end, the CAP strongly urged the CMS to reinstate the MIPS bonus points for high-priority measures and asked that the CMS maintain the 3-point floor for quality measures, especially considering the removal of bonus points for high-priority and outcome measures. Additionally, the CAP urged the agency to remove the proposed Screening for Social Drivers of Health measure from the proposed 2023 pathology measure set as it does not align with non-patient-facing pathology practice.

The CAP also encouraged the CMS to ensure that independent pathology practices can be successful as the QPP evolves. However, until such time as the new MIPS Value Pathways (MVPs) allow single-specialty, independent pathology practices to be successful, the CMS should continue traditional MIPS.

New Additions to Federal Information Blocking Regulations Have Minor Impact on Pathologists

Starting October 6, 2022, the Information Blocking Regulation outlined in the Cures Act final regulation expands to all electronic health information (EHI) that all physicians, including pathologists, must comply with. The Information Blocking requirements originally went into effect on April 5, 2021, for a narrow definition of EHI. The October 2022 date expands the EHI definition subject to the Information Blocking requirements. Because the definitions within the regulation include all forms of electronic sharing of information, faxing pathology reports continues to be an acceptable practice.

The Information Blocking Regulation requires all physicians to make their office notes, final laboratory results, and other final diagnostic reports available to patients as soon as the physician’s office receives an electronic copy. However, most pathologists do not have to change the way they report, and they can continue to report finalized reports from the laboratory information system (LIS) to ordering systems—with reasonable turnaround time.

Nevertheless, the regulation continues to specify that pathologists should not delay the release of laboratory and pathology results until the ordering clinician’s review. There are case-by-case exceptions to this rule (such as to prevent harm to a patient), though there are no blanket exceptions. Physicians have no monetary penalties yet, but the regulatory rulemaking process in the future will determine those.

The CAP has a fact sheet available for pathologists on how to comply with this regulation.

CAP and Laboratory Groups Demand Congress Stop Clinical Laboratory Payment Cuts

The CAP and 25 other organizations asked congressional leaders to protect payment for clinical laboratory services by supporting the bipartisan and bicameral Saving Access to Laboratory Services Act (SALSA). Citing adverse impacts on laboratories and patients, the CAP advocates for improvements to how the CMS collects laboratory data and stops next year’s 15% payment cut to more than 800 clinical laboratory tests.

In the September 8 letter, the coalition, led by the American Clinical Laboratory Association and including the American Medical Association, urged congressional leadership to pass the SALSA act as a solution that would set Medicare reimbursement for laboratory services. In addition, the SALSA act would provide the CMS power to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services.

The SALSA legislation would also address the CAP’s concerns with clinical laboratory payment rates because of PAMA. Absent congressional intervention, laboratories face a 15% cut in January of 2023.

The CAP has long expressed concern about PAMA’s burdensome reporting requirements and the CMS’ failure to include such a large portion of the laboratory market in payment reporting, resulting in skewing PAMA payment rates.

The CAP Urges CMS to Maintain Current APC level for CPT Code in Final Hospital Outpatient Regulation

The CAP asked the Centers for Medicare & Medicaid Services (CMS) to reevaluate the ambulatory payment classification (APC) for cytopathology CPT code 88121 in the proposed 2023 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center Payment System regulations. The CAP advocates fair payment for all services pathologists provide—actively representing pathologists’ interests in nearly every payment-related policy discussion.

In the September 13 letter to the CMS, the CAP outlined how the proposed recalibration of APC Relative Payment Weights for CPT Code 88121 would be a detrimental rate-setting issue for pathologists. The data will not reflect the actual cost of these specific and complex diagnostic procedures by recalibrating and grouping several services or procedures into appropriate clinically and economically homogeneous APCs. “The costs associated with performing this service is nearly three times the cost of an APC 5672 “Level 2 Pathology” service, based on physician fee schedule technical component cost differences. This proposed reassignment creates a resource cost rank order anomaly with other physician services and the technical costs will not be fully recovered from each unit of service,” the CAP stated. Therefore, the CAP wants to CMS to maintain the assignment of APC 5673 for CPT code 88121.

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