ePolicy News September 2020

August 31, 2020

Find a list of the stories in the September 2020 edition of ePolicy News below.

ASCP CSTP Chair Joins National Testing Implementation Forum
Gary Procop, MD, MS, MASCP, Chair of the ASCP Commission on Science, Technology and Public Policy, has joined the Trump Administration’s newly-created National Testing Implementation Forum. The forum is the Administration’s response to ASCP’s call for the creation of a National Testing Task Force. Dr. Procop attended the panel’s August 13 meeting, where laboratory experts offered input to federal leaders about COVID-19, laboratory testing and diagnostics.

Read more.

Trump Administration Urged to Prioritize COVID-19 Testing
The demand on clinical laboratories for coronavirus testing is outpacing test capacity. In response, ASCP, the American Medical Association and several other medical associations are urging the U.S. Department of Health and Human Services to revise its guidelines so that COVID-19 diagnostic testing is prioritized for those with the greatest need.

ASCP Articulates Serious Concerns with ACS Cervical Cancer Guidelines
The American Cancer Society’s recently revised cervical cancer guidelines have drawn concern from ASCP. The guidelines recommend that individuals with a cervix initiate cervical cancer screening at age 25 years and undergo primary HPV testing every 5 years through age 65 as the preferred screening method.

HHS Reverses Course on LDTs, Bars FDA from Requiring Premarket Review
In a surprising reversal, the U.S. Department of Health and Human Services has declared that the Food and Drug Administration does not have the authority to require clinical laboratories to seek pre-market approval of laboratory tests they have created.

Highlights of ASCP 2020 Annual Meeting Virtual
Be sure to join us for ASCP 2020 Virtual from Sept. 9-12. In this exclusively virtual experience, you’ll have the opportunity to easily attend, interact and experience the same unique, timely education while connecting with a global community.

CMS to Resume Routine Laboratory Inspections
The Centers for Medicare & Medicaid Services is resuming routine inspections and surveys of healthcare facilities, including clinical laboratories.

ASCP Supports Consistent Terms in Testing in Precision Medicine
ASCP is pleased to announce its support for A White Paper on the Need for Consistent Terms for Testing in Precision Medicine. The paper represents the collective effort of a working group comprised of patient advocacy organizations, professional societies and industry partners dedicated to identifying and adopting consistent biomarker and germline genetic testing terminology for patient communication.

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

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ASCP ePolicy News is supported by an unrestricted grant from Hologic.

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