Advocacy Update

February 7, 2023

In this Issue:

Cancer Leadership Council Wants Health Plans to Cover Molecular Diagnostic Tests

The Cancer Leadership Council, of which the CAP is a member, asked the Centers for Medicare & Medicaid Services (CMS) to ensure that health plan essential benefits include molecular diagnostic tests and chimeric antigen receptor (CAR) T-cell therapies. The council wants to ensure patients covered by these health plans cover cutting-edge cancer treatment options. The CAP has advocated to ensure patients have access to tests and new therapies.

In the January 31 letter, the Cancer Leadership Council outlined how health plans created under the Affordable Care Act (ACA) should improve their health care benefits offered to their beneficiaries. Specifically, the council noted current essential health care benefits benchmarks lag the scientific advancements for cancer treatments. The group identified two concerns related to cancer treatment advancements: molecular diagnostic tests and CAR T-cell therapies.

In the letter, the group said “[essential health care benefit] benchmark plans may not include coverage of molecular diagnostic tests that are required to fully characterize a patient’s cancer and to support treatment decision-making...Coverage and payment for these tests may not be available due to the limitations of EHB-benchmark plans and the ACA plans that rely on those benchmarks.”

Doing More with Less

Human factor engineering looks for how we design systems, work environments, and work processes that make it easier for workers to do the right thing, but also to be able to engineer barriers to prevent workers from doing the wrong thing, taking incorrect or erroneous actions, or shunting error pathways away from resulting in patient harm.

Learn how applying Human Factor Engineering can improve quality and streamline processes to increase efficiency, despite resource limitations in pathology and laboratory settings from Moira Larsen. MD, FCAP and Ethan Larsen, PhD by attending their course “Doing More with Less- Human Factors Engineering in Pathology” at the 2023 Pathologists Leadership Summit, April 15-18, 2023.

Register now

Rep. Bucshon and Other Lawmakers Review CAP Feedback on Medicare Pay Reform

In the wake of years of ongoing Medicare payment cuts and dwindling congressional relief, Rep. Larry Bucshon, MD, (R-IN) called for oversight hearings on Medicare physician payment reform as he works through stakeholder comments on flaws in the system set up by the Medicare Access and CHIP Reauthorization Act (MACRA) to find solutions with bipartisan support. The CAP, the American Medical Association (AMA) and over 100 organizations recently asked Congress to address substantive Medicare payment reform, recognizing that cuts will continue until broader reforms are implemented.

Rep. Bucshon and other legislators are reviewing responses they received from their request for information (RFI) from stakeholders on improving MACRA. A bipartisan group of eight House lawmakers, spearheaded by Rep. Ami Bera, MD, (D-CA) and Rep. Bucshon asked stakeholders how to fix MACRA without dramatically increasing Medicare spending.

The CAP has provided Congress with recommendations to improve Medicare’s payment program.

Advanced Alternative Payment Model Incentive Extended by CMS

Because of Congress’s actions in the December 2022 omnibus bill, the CMS announced that the incentives for the Advanced Alternative Payment Model (APM) will be extended until the payment year 2025 for participating physicians.

In December 2022, Congress enacted the APM Consolidated Appropriations Act, extending the APM Medicare incentive of a 3.5%through 2025. Without this there would have been a one-year gap with no statutory incentives for Advanced APM participation for the payment year 2025.

For the 2023 performance period and the associated 2025 payment year, the APM incentive will decrease from 5.0% to 3.5%. Additionally, the qualifying participant payment amount and patient count thresholds for participation in Advanced APMs will remain frozen at 50% and 35%, respectively, for the performance period 2023.

What Do I Need to Do to Receive the APM Incentive Payment?

If you meet the requirements to be a qualifying participant in the 2023 performance period, you will not need to do anything to receive your payment in 2025 unless the CMS cannot verify your Medicare billing information.

If you do not receive your payment after initial payments are made, a public notice will be posted with a list of names that indicates that you will need to verify your Medicare billing information. If you do not verify your Medicare billing information by the date in the notice, then the CMS will not be able to issue your APM incentive.

For more information, check out the Frequently Asked Questions on the QPP website or contact the Quality Payment Program at or 1-866-288-8292.

FDA Down Classifies AI Software Algorithm Devices

On February 2, the Food and Drug Administration (FDA) published a final order where the agency down-classified software algorithm devices to assist in digital pathology to class II. This action allows these devices to be subjected to less regulatory controls if risks are mitigated. The FDA’s class II categorization will enable manufacturers of such devices to go through a less burdensome process of obtaining FDA clearance than would otherwise be the case.

The AI software algorithms for devices provides information to the user about presence, location, and characteristics of areas of the image with clinical implications. That information from such devices is intended to assist the user in determining a pathology diagnosis. To mitigate the identified risk with software algorithm devices, the FDA is applying such as a statement with the device containing a description of situations in which the device may fail or may not operate at its expected performance level (eg, poor image quality or for certain subpopulations).

Georgia Pathologists, CAP Support Network Adequacy Bill

On February 1, the Georgia Association of Pathologists (GAP) in partnership with the CAP, urged the state legislature to support Senate Bill 20 requiring health plan network adequacy and adequate access to clinical laboratory services to ensure covered persons have full access to their plan’s covered benefits and health care services. The CAP works closely with state pathology societies to advocate for network adequacy laws requiring health plans to be evaluated by their state insurance departments for enrollee access to hospital-based physician specialists, inclusive of pathologists.

GAP President Lara Harik, MD, FCAP, wrote “The GAP and CAP believe that ensuring health plan network adequacy is indispensable to providing patients with in-network physician services, including pathology and clinical laboratory services. Pathology and clinical laboratory services are integral to patient diagnosis and treatment, and the failure of any health plan to adequately contract for those services, and provide enrollees with geographic and timely access, should be scrutinized, and monitored by the Insurance Department, as required under the legislation”

The GAP said “a health plan that does not have these services under contract for its enrollees is fundamentally deficient and may result in harm to Georgia patients.”

The CAP will work closely with GAP and the Medical Association of Georgia (MAG) to support Senate Bill 20.

New Month - New News Quiz

It’s February and that means a new News Quiz! Test your knowledge with the February Advocacy News Quiz. See how you compare against your fellow CAP members and brag about your top scores on social!

Take the news quiz