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Notice and Comment Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA)

Latham & Watkins LLP

HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

Latham & Watkins LLP on

The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

Holland & Knight LLP

CMS Proposes Transitional Coverage for Emerging Technologies

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more

Foley & Lardner LLP

EUAs for LDTs no Longer Required, but at the Expense of PREP Act Immunity

Foley & Lardner LLP on

On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more

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