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HHS Limits Use of Guidance Documents in Civil Enforcement Actions and Issues First Good Guidance Practices Petition Response

USA - January 19 2021 On January 14, 2021, the Department of Health and Human Services (“HHS”) published the Transparency and Fairness in Civil Administrative Enforcement…

Jonah D. Retzinger

HHS Limits the Use of Guidance Documents in the Good Guidance Practices Rule and Advisory Opinion 20-05

USA - December 10 2020 On December 7, 2020, the Department of Health and Human Services (“HHS”) published the Good Guidance Practices final rule (“Rule”), which limits…

Jonah D. Retzinger

OIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework

USA - December 3 2020 On December 2, 2020, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") and the Centers for Medicare & Medicaid…

David E. Matyas, Jason E. Christ, Anjali N.C. Downs, Karen Mandelbaum, Teresa A. Mason, Jennifer E. Michael, Victoria Vaskov Sheridan, Carrie Valiant, Lesley R. Yeung

CMS Proposes to Expand the Scope of Medicare Coverage Determinations

USA - September 4 2020 On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would, for the first time, establish formal…

Medicare Expands Access to Genetic Diagnostic Tests for Certain Ovarian and Breast Cancers

USA - February 6 2020 On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare…

Machelle Dunavant Shields, Lesley R. Yeung