Regulations and Regulatory Advocacy

The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk.
CMS鈥 proposal mandating the disclosure of negotiated charges between health plans and hospitals is the wrong approach, exceeds the Administration's legal authority and should be abandoned, AHA told the agency today.
The United States Pharmacopeia (USP) today notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards.
The United States Pharmacopeia (USP) recently finalized revisions to general chapter <797> (Pharmaceutical Compounding and Sterile Preparations). In addition, USP in 2016 finalized a new general chapter, <800> (Hazardous Drugs Handling in Healthcare Settings). Both general chapters have鈥
The AHA and five other hospital groups today filed a friend-of-the court brief urging the U.S. District Court for the Eastern District of Washington to prevent the Department of Homeland Security鈥檚 public charge rule from taking effect Oct. 15.
The AHA and five other hospital groups filed a friend-of-the court brief urging the U.S. District Court for the Eastern District of Washington to prevent the Department of Homeland Security鈥檚 public charge rule from taking effect Oct. 15. 
The AHA today urged the Centers for Medicare & Medicaid Services to withdraw its proposal to rescind a 2015 rule that requires states to develop and submit access monitoring review plans for certain Medicaid services.
The rule would force millions of immigrants 鈥渢o choose between accepting public services and accepting a green card 鈥 an impossible choice,鈥 the brief states. 
The AHA and five other hospital groups September 11, 2019, filed a friend-of-the court brief urging the U.S. District Court for the Northern District of California to prevent the Department of Homeland Security鈥檚 public charge rule from taking effect Oct. 15.