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FDA proposes codifying some medical device decision review deadlines
The FDA has proposed codifying procedures and timeframes of supervisory review of significant medical device decisions in the Center for Devices and Radiological Health (CDRH). These regulations will...
$350M judgment reversed, failure to maintain patient comprehensive care plans insufficient proof
A relator’s evidence at trial about a multi-facility nursing home operator’s failure to maintain comprehensive care plans as required by Medicaid regulations, was not sufficient to...
Regulatory agenda focuses on cost-sharing, over-the-counter drugs
HHS issued its Semiannual Regulatory Agenda, publishing abstracts of departmental rulemakings that are in process and that will continue in 2017. The abstracts describe agency actions in the Proposed...
Trump’s CMS endorses Medicaid work requirements
Blaming the previous administration for the expansion of Medicaid coverage to able-bodied adults under section 2001 of the Patient Protection and Affordable Care Act (ACA), the Trump Administration...
Record supports Medicare overpayment determination for elderly patient inpatient admission
The admission of an elderly patient as an inpatient was not medically necessary or reasonable in light of the record and, thus, the final decision issued by the acting Secretary of HHS that the...