Advocacy Update

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In This Issue:

The CAP has long advocated for cutting-edge laboratory technology standards with the Centers for Medicare & Medicaid Services (CMS). With rapid changes in technology and integration of the health care delivery system, clinical laboratories are an integral part of the health systems. The CAP participated at the November meeting of the Clinical Laboratory Improvement Advisory Committee as the CAP sought to ensure regulations keep up with new and emerging technologies.

As a leader in laboratory quality and advocacy, the CAP delivered a statement regarding guidance for bioinformatic and emerging technologies.

Next-Generation Sequencing (NGS) – Bioinformatics 

The CAP is dedicated to assuring the accuracy of next-generation sequencing (NGS)-based testing in clinical laboratories through its accreditation and proficiency testing programs. In ensuring the accuracy and reliability of NGS testing, the CAP requested that updated “CLIA certification should be required of any organization performing portions of [NGS] testing process.” Moreover, to ensure the accuracy of NGS tests, the CAP urged the CMS to revise CLIA personnel requirements for bioinformaticists, as these roles need a specialized expertise.

Emerging Technologies

New and emerging laboratory technologies and nontraditional testing workflow models have increased dramatically in clinical laboratory testing. In the statement, the CAP outlined how the organization’s Accreditation Program works to update the checklist to reflect advances in NGS technology. “Since 2012, the CAP revised the NGS checklist items six times to add recommended metrics and quality control parameters for this dynamic field. However, “under the current regulatory standards, clinical laboratories are unable to test their total test system if a portion of the tests is performed in a distributive testing model, making it difficult to assess the complete process and discourages a good quality indicator.”

The CAP urges the CMS to create new CLIA standards for emerging technologies.

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The Maryland Society of Pathologists (MSP) and the CAP asked the state’s insurance department to consider adding critical hospital-based physicians into their insurance networks. The MSP, along with the American College of Radiology, and the CAP, urged the Maryland Insurance Administration to amend a 2017 network adequacy rule to ensure it includes pathologists, radiologists, and other critical hospital-based physician specialties. This is the second time that the Maryland’s Insurance Administration is considering this regulation.

“It is important to underscore patient advocacy group support for holding insurance plans accountable for hospital-based physician network adequacy. As evidence of this support, we are submitting the attached National Declaration On Patient Access, endorsed by numerous national patient advocacy groups and multiple physician organizations. This document unequivocally calls upon state and federal regulators to adopt requirements to assess health plan network adequacy for patient access to in-network hospital and facility-based specialty physicians,” the groups stated in its November 4 comments submitted to the Associate Commissioner for Life and Health David Cooney at the Maryland Insurance Administration. The groups also cited comments submitted to the agency in 2017 by the office of the Maryland Attorney General.

Several states, including New Hampshire, Washington, and Louisiana, have adopted network adequacy provisions that specifically include the hospital-based physician specialties.

The CAP will continue to follow developments on this proposal.

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Members from the Virginia Society of Pathologists will receive an update from CAP Economic Affairs Committee Chair Stephen Black-Schaffer, MD, FCAP, on federal and state advocacy on November 16.

To strengthen the profession of pathology at the local level, the CAP supports state pathology societies to bolster advocacy efforts on issues such as private insurance, billing, and scope of practice. The CAP’s leaders also directly speak and visit with pathologists at several state pathology society meetings throughout the year.

On November 16, Dr. Black-Schaffer will review the CAP’s advocacy efforts to enact federal surprise billing legislation, protect the value of pathology services, and the upcoming Pathologists Leadership Summit, among other topics.

Check our state pathology societies webpage for more information about support the CAP provides to state societies.

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The CMS published the final the 2020 Medicare Physician Fee Schedule and the Quality Payment Program regulations, which will affect payment for pathology services in 2020. The CAP hosted a webinar where experts reviewed the final regulation changes that will impact your pay, your practice, and your participation in the Merit-based Incentive Payment System (MIPS).

Missed the webinar? Check out the recording and download the slides.

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Join over 50 of your fellow CAP members who have already taken the November Advocacy News Quiz. See how you compare to your fellow CAP members by sharing your results on social media.

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