Health Care Law News and Insights

On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance1 for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the Medicare Conditions of Participation (CoPs). The draft co-location guidance is a long-awaited clarification of CMS's views...

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Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next "Capitol Hill Healthcare Update" will be posted on June 3. LAWMAKERS QUESTION DEMOCRATS' STRATEGY ON DRUG PRICING...

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In January 2019, FDA issued an update to the Working Model for its Software as a Medical Device ("SaMD") Precertification Program. Readers are encouraged to read Finnegan's summary of the initial Working Model. Along with this version of the Working Model, FDA also issued two separate companion documents: the Regulatory Framework for conducting...

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