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JANUARY 23, 2019
 
 
 
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Healthcare Legal News
In house attorneys looking for a better way to organize, vet and easily retrieve legal news created the National Law Review on-line edition.

Around the clock, the National Law Review's editors screen and classify breaking news and analysis authored by recognized legal professionals and our own journalists.

There is no log in to access the database and new articles are added hourly.
 
 
 
 
With the recent scoop from Politico that the Trump Administration is considering giving states the ability to implement Medicaid block grants, there has been considerable speculation on what the Administration is planning. Although we don’t know exactly what the Administration has in mind, there increasing skepticism on the legality of this move. So we are laying out the fundamentals and past history as we await the final guidance. More on Block Grants Here >
 
 
 
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On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability… [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1] More on FDA Guidance Here >
 
 
 
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On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients in financial need (Arrangement). OIG noted that the Arrangement did not meet the regulatory exception for permitted waivers of cost-sharing amounts under the Civil Monetary Penalties Law (CMP) but ultimately decided not to impose administrative sanctions in connection with the Arrangement.  More on OIG Advisory Opinion Here >
 
 
 
 
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