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Dear Speaker Pelosi, Leader Schumer, Minority Leaders McCarthy and McConnell:

As organizations representing patients, health care professionals, laboratories, hospitals and health systems, and diagnostic manufacturers, we urge Congress to take immediate action to delay the harmful cuts to the Clinical Laboratory Fee Schedule (CLFS) and pause the next round of private payer data reporting that both take effect on January 1, 2022. While we are grateful that Congress delayed the implementation of CLFS cuts in 2021 as part of the Coronavirus Aid, Relief, and Economic Security Act, we urge you to extend this delay—for both the 2022 cuts and the next private payer data reporting period—as the Public Health Emergency has not ended, and laboratories must continue to respond.

As we approach the end of the second year of the COVID-19 pandemic, our nation’s clinical laboratories continue to work tirelessly on the front lines of the response. However, the flawed implementation of the Protecting Access to Medicare Act (PAMA) has resulted in drastic cuts to some of the most frequently ordered clinical laboratory tests. In just a few weeks, laboratories are scheduled to see cuts as large as 15 percent to some of the most common tests on their menus—basic clinical laboratory tests that are essential to the health and wellbeing of Americans.

Reducing access to clinical laboratory services drives up the cost of care for patients and taxpayers. Millions of Americans who are managing diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, opioid dependency, and countless other common diseases and conditions rely heavily on access to these routine lab tests to prevent costly interventions. Worse, these cuts will undermine the basic public health and clinical laboratory infrastructure that is needed to quickly respond to emerging and future public health threats.

PAMA cuts have had a detrimental impact on clinical laboratory infrastructure, particularly labs who serve rural and underserved communities. In addition, laboratories are not immune to general market conditions. As supplies and labor costs continue to grow, laboratories struggle to maintain and hire essential personnel. Further cuts will continue to damage the nation’s laboratory infrastructure at a time when it is needed most.

Laboratories also provide timely results daily to patients in long-term care facilities, many of whom require routine monitoring due to the increased risk of morbidity and mortality among older Americans. This same day turnaround helps identify any critical issues at an early stage, keeping patients healthier and preventing more costly interventions. Patients who are frail or reside in medically underserved communities, including rural areas, are at particular risk. These communities and patients rely on a shrinking number of smaller, local laboratories: laboratories that will face the brunt of these cuts.

Without action by Congress, Medicare patients could lose access to essential laboratory services. Without ready access to lab tests, patients risk missed or delayed diagnoses, increased barriers to maintaining their health, and forgoing the opportunity to prevent even worse health outcomes or disease. In a medical age where technology is pushing health care closer to patients, the bureaucratic policies implemented through PAMA will drive care and the promise of better health further away from patients.

We urge you to include a one-year delay to the 2022 Medicare CLFS cuts and private payer data reporting period in the continuing resolution that is currently being negotiated. If you have questions, please contact Erin Morton with the National Independent Laboratory Association ([email protected]) and Tom Sparkman with the American Clinical Laboratory Association ([email protected]).

Sincerely,

AdvaMedDx

American Academy of Family Physicians

American Association for Clinical Chemistry

American Association of Bioanalysts

American Clinical Laboratory Association

American Hospital Association

American Medical Technologists

American Society for Clinical Laboratory Science

American Society for Clinical Pathology

American Society for Microbiology

AMGA

Association for Molecular Pathology

Association of Public Health Laboratories

California Clinical Laboratory Association

Cancer Support Community

Caregiver Action Network

Caregiver Voices United

Infectious Diseases Society of America

Medical Group Management Association

National Association for the Support of Long Term Care (NASL)

National Consumers League

National Independent Laboratory Association

New York State Clinical Laboratory Association

Point of Care Testing Association

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