Pharmaceutical and Device Florida AHCA Submits Concept Paper to HHS Thomas Sullivan Sep 12, 2019 0 Recently, the Florida Agency for Health Care Administration (AHCA) recently submitted a “concept paper” to the United States…
FDA FDA Finalizes Revised Guidance on REMS Revisions and Modifications Thomas Sullivan Sep 11, 2019 0 The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation…
FDA Industry Reaction Mixed to FDA Draft Guidance on Real World Data and… Thomas Sullivan Sep 10, 2019 0 In May, the US Food and Drug Administration (“FDA”) released a draft guidance outlining its current thinking on real-world data…
Events CMS to Host Public Meeting to Address Opioid Epidemic Thomas Sullivan Sep 9, 2019 0 On Wednesday, August 28, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will host a public meeting…
Accountable Care Organizations HHS OIG Reports Policy Changes Affect the Efficiencies of ACO’s Thomas Sullivan Sep 6, 2019 0 There’s been interesting news lately in the accountable care organization (ACO) world. CMS recently announced that participants in…
CMS CMS Proposed Physician Fee Schedule Calls for Revoking Medicare Billing… Thomas Sullivan Sep 5, 2019 0 CMS' proposed 2020 Medicare Physician Fee Schedule includes substantial changes to the rules for obtaining and maintaining…
Accountable Care Organizations CMS Advanced Payment Model Physician Participation Doubling 2017-2018 Thomas Sullivan Sep 4, 2019 0 The number of doctors participating in advanced payment models (APMs) nearly doubled in 2018 to 183,306 compared to 99,076 doctors…
CMS Medicare Issues Proposed Payment Rule Including Changes to Bundled Payments… Thomas Sullivan Sep 3, 2019 0 The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that would update payment policies for the Medicare…