Author: Claire H. Topp

Claire H. Topp

Claire works in three diverse sectors – health care, tax exempt organizations, and standards development organizations.

Claire is a frequent lecturer on governance best practices, private foundation excise taxes, Stark II, Medicare/Medicaid fraud and abuse and negotiating employment agreements for physicians, dentists and advanced practice nurses.

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“Pathways to Success” – CMS Finalizes Overhaul of National ACO Program

Claire H. Topp

On December 21, 2018, CMS announced a final rule, subsequently published in the December 31 issue of the federal register, significantly overhauling the Medicare Shared Savings Program (“MSSP”). Among the important changes in the final rule is a redesign of MSSP’s participation options. Under MSSP, providers of services and suppliers participating in an Accountable Care...

FDA Testing New Approaches for Review of Digital Health Device Applications

Claire H. Topp

On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program (“Pre-Cert”). Pre-Cert was originally announced in 2017 as part of the FDA’s Digital Health Innovation Action Plan. The FDA envisions the program as a streamlined process...

OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement

Claire H. Topp

On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction...