Advocacy Update

• Medicare Includes Diagnostic Codes for Social Determinants of Health in Inpatient Regulation
• New CDC Center to Forecast Future Pandemics
• FDA Warns About Risks of Non-Invasive Prenatal Screening Tests
• 2022 Pathologists Leadership Summit Keynote Speaker Announcement
• Test Your Advocacy News Intelligence

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.

In the proposed regulation, the CMS asked for specific information on how including diagnosis codes on hospital patients’ social determinants of health on Medicare claims could improve equity. The CMS wants to understand the impact of diagnosis codes on social determinants of health, which could better understand the severity or complexity of certain issues, such as housing and access to food.

The CMS also asked for input to improve its current data collection and analysis to understand disparities better. The agency asked for stakeholder input on improved data stratification and data measurement, including which measures of disparity should be prioritized and used for data reporting.

Other items in the proposed 2023 Inpatient Hospital Regulation include:

• Payment adjustment for domestically sourced supplies. The CMS is considering adding a payment adjustment for hospitals that source their N95 respirators from domestic manufacturers.
• Hospital inpatient quality-reporting program. The CMS is seeking to add 10 new measures, including one that assesses a hospital's commitment to equity, one on opioid-related adverse events and one that captures screening of social determinants of health.
• Hospital readmissions reduction program. The CMS proposed to resume the measure that tracks and penalizes hospitals for 30-day readmissions after pneumonia hospitalization beginning in fiscal 2024.

The CAP is reviewing the proposed 2023 regulation and will provide feedback by June 17.

On April 19, the White House held an event announcing the new Center for Forecasting and Outbreak Analytics under the CDC. The new center, which the CAP supports, will provide forecasting for infectious diseases. The CAP had urged the federal government to centralize resources to counter the current pandemic and prepare for future ones, especially those elements concerning diagnostic testing.

The Center for Forecasting and Outbreak Analytics aims to improve outbreak and public health threat response by using infectious disease modeling and analytics to enable timely, effective decision-making by leaders at federal, state, and local levels. The CDC began planning to create the center in August 2021, with $200 million of initial funding coming from the American Rescue Plan Act. In addition, the agency has awarded $26 million to federal partners and academic institutions to improve modeling and forecasting methodologies.

On April 19 the Food and Drug Administration (FDA) issued a warning about the risks of false results from genetic non-invasive prenatal screening (NIPS).

While health care providers widely use NIPS tests, none have yet been authorized or cleared by the FDA. The agency notes that NIPS test are screening tests, which may only tell you the risk of the fetus having certain genetic abnormalities, but that they are not diagnostic tests, which would confirm or rule out a genetic abnormality.

The NIPS tests currently being offered are laboratory-developed tests (LDTs) that analyze small fragments of fetal DNA circulating in a pregnant person’s blood to determine the risk that the fetus has certain genetic abnormalities.

The FDA said it is aware of reports that patients and health care providers have made critical health care decisions based on results from these screening tests alone and without additional confirmatory testing. Specifically, pregnant people have ended pregnancies based only on the results of NIPS tests.

In January, The New York Times published a story questioning the accuracy of the tests. Dozens of congressional Republicans then wrote the FDA and asked questions regarding the agency’s awareness of problems with the tests.

In the FDA warning, the agency recommended that patients talk to a genetic counselor or other health care provider before deciding to have prenatal testing and discuss which tests to use, including genetic screening tests such as NIPS test.

In addition, the agency urged patients not to use the results of screening tests alone to make decisions about their pregnancy because the results of the tests may not accurately reflect whether the fetus has a genetic abnormality. Additional testing may require invasive procedures to obtain a sample, such as amniocentesis or chorionic villous sampling, which carry a small risk of miscarriage.

The FDA recommended that health care providers discuss with their patients the benefits and risks of prenatal tests, including genetic screening tests such as NIPS tests. Providers should not use the results of screening tests alone to diagnose chromosomal abnormalities or disorders.

The CAP is pleased to announce that The New York Times best-selling author and former ABC News anchor Dan Harris will be the keynote speaker during the Spring House of Delegates meeting at the Pathologists Leadership Summit.

Dan Harris will be the keynote on Saturday, April 30 at the 2022 House of Delegates Spring Meeting—kicking off the Pathologists Leadership Summit. A leader in mental wellness, Mr. Harris is the former co-anchor for the weekend edition of Good Morning America on ABC News. He is also the author of 10% Happier, a #1 New York Times best-selling book about wellness. As an exclusive member event, there is no fee to register for the Pathologists Leadership Summit.

This is the last week to register for this hybrid event. Want to learn more? Check out this preview podcast of the Pathologists Leadership Summit from Jonathan Myles, MD, FCAP, chair of the CAP’s Council of Government and Professional Affairs.

Learn more and register

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