ePolicy News November 2023

FDA Rejects Requests to Extend LDT Proposed Rule Comment Period
The U.S. Food and Drug Administration is rejecting requests from ASCP and others seeking an extension of the 60-day comment period on the agency’s proposed rule claiming oversight of laboratory developed tests (LDTs). As it stands now, the deadline to submit comments is Dec. 4. Read more.

Podcast Examines the Impact of the FDA’s Proposed Rule on Laboratory Developed Tests
A recent ASCP podcast about laboratory developed tests (LDTs) is being made available as a resource for members to learn about LDTs and how they affect the medical laboratory. A panel of ASCP experts also weighed in on how proposed new regulation on LDTs by the Food and Drug Administration will affect the delivery of patient care. Read more.

CMSS Grant Supports Development of Best Practices for Guidelines in the Communication of New Cancer Diagnoses
ASCP has received a $100,000 grant from the Council of Medical Specialty Societies (CMSS) to fund an initiative to undertake a thorough review of current guidelines regarding the notification of patients of a cancer diagnosis and to develop a set of best practices to make sure these results are communicated in an effective, consistent, and timely manner. Read more.

ASCP 2023 Features CDC OneLab Virtual Reality Training on Pandemic Preparedness
During the ASCP 2023 Annual Meeting, laboratory visibility and representation of a unified laboratory workforce took center stage. ASCP, through a cooperative agreement with the Centers for Disease Control and Prevention (CDC) in support of the CDC OneLab Initiative, presented training designed to assist the laboratory workforce in responding more effectively to future pandemics. Read more.

Alliance for Women’s Health and Prevention Awards Inaugural Grant to ASCP to Examine Cervical Cancer Screening in Women from Diverse Populations in the U.S.
Physicians in the U.S. are seeing an alarming increase in the number of advanced cervical cancer cases diagnosed, particularly among Black and Hispanic women in lower socioeconomic backgrounds who may not have access to adequate healthcare coverage. ASCP has received a $750,000 grant from the Alliance for Women’s Health and Prevention to analyze recent trends in cervical cancer screening and detection among a diverse population of women who are underrepresented in the data used by the U.S. government to set screening guidelines, with a goal of advancing policy that drives equitable access to health care among all women and girls. Read more.

ASCP, AMA Urge Support for Medicare PFS Budget Neutrality Legislation
ASCP, the American Medical Association (AMA), and other medical societies are encouraging congressional leaders to support legislation to reform the budget neutrality policies applied to the Medicare Physician Fee Schedule (PFS). The legislation would provide much needed stability to the PFS, which affects reimbursement to pathologists and the laboratory. Read more.

 House Committee Considers Medicare Reimbursement Legislation
On Oct. 19, the House Energy and Commerce Subcommittee on Health held a hearing titled “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors.” The hearing was intended to address “fine-tuning Medicare payment to best serve seniors and strengthen the program.” During the hearing, two bills supported by ASCP were discussed. Read more.

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