Previous Advocacy Updates

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 maintain the highest standards in diagnostic medicine, the CAP opposed several changes to the Centers for Medicare & Medicaid Services (CMS) staffing qualifications recommendations in a proposed 2023 CLIA regulation.

The Biden administration released the final surprise billing regulation, which follows a court decision that struck down an earlier policy related to the independent dispute resolution process.

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).

On August 4, the Biden administration declared the monkeypox outbreak a public health emergency, allowing for increased flexibility to dedicate the necessary resources to stop the virus’ spread.

The CAP and dozens of other medical associations are calling on Congress to take immediate action to mitigate Medicare payment cuts scheduled to go into effect on January 1, 2023.

In a letter to Congress on July 20th, the CAP and nearly 50 organizations representing physicians, patient advocates, and health care industry have asked Congress to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act’s in the FDA user fee reauthorization bill as key lawmakers negotiate a final version of the legislation.

The CAP demanded that Congress take action to stop health insurance companies from devaluing pathology services.

On July 7, the Centers for Medicare & Medicaid Services (CMS) released its proposed 2023 Medicare Physician Fee Schedule signaling an advocacy win for the payment of pathology technical component services.

Special Issue: On July 7, the Centers for Medicare & Medicaid Services issued the proposed 2023 Medicare payment regulations, including the proposed 2023 Medicare Fee Schedule and Quality Payment Program regulations.

The CAP signed a memorandum of understanding (MOU) with the Centers for Disease Control and Prevention (CDC) to provide assistance and expertise with diagnostic surge testing during public health emergencies.

The CAP signed a memorandum of understanding (MOU) with the Centers for Disease Control and Prevention (CDC) to provide assistance and expertise with diagnostic surge testing during public health emergencies.

The Senate Committee on Health, Education, Labor, and Pensions on June 14 approved a package of bills to reauthorize existing Food & Drug Administration (FDA) user fees and included new legislation (the VALID Act) which would authorize the FDA to regulate in vitro diagnostics (IVDs) including laboratory developed tests.

The Centers for Disease Control and Prevention (CDC) released specimen collection guidelines and PCR test procedures for monkeypox virus on May 31.

On May 17, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released the latest version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act as part of the next user fee authorization bill for the Food and Drug Administration (FDA). The latest version of VALID Act represented a positive step in the right direction on the oversight of laboratory-developed tests (LDTs) and captured several of the CAP’s long-held policy positions.

The CAP, the Leukemia and Lymphoma Society, and almost 90 other medical and health care professional organizations asked Congress to diversify medical clinical trials by including diversity as part of 2022 Food and Drug Administration (FDA) prescription drug user fee reauthorization legislation.

A record-breaking number of CAP members advocated to protect the value of pathology services while meeting with their federal legislators on May 3 during the CAP’s Hill Day. Hundreds of CAP members discussed how Congress can mitigate Medicare cuts, prepare for medical workforce shortages, and ensure funding for future pandemic preparedness.

CAP members discussed strategies for how they will engage their members of Congress at the Pathologists Leadership Summit on May 2.

On April 18, the Centers for Medicare & Medicaid Services (CMS) released the proposed 2023 Medicare Inpatient Prospective Payment System regulation, which outlined goals to improve health equity in health care. In the proposed regulation, the CMS asked for stakeholder input on social determinants of health, including the impact of new diagnostic codes and improvements in health data collection. The CAP has supported legislative efforts to understand the social determinants that drive health care disparities in the United States and will provide recommendations for the final 2023 regulation.

With the significant increase in the number of nontraditional testing sites since the COVID pandemic, the CAP urged the Centers for Medicare & Medicaid Services to consider the optimal oversight for nontraditional testing sites and point of care testing.