The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more
A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more
On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect. The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that...more
6/2/2016
/ End-of-Life-Care ,
Health Care Providers ,
Healthcare Facilities ,
Immunity ,
Medical Records ,
New Legislation ,
Notice Requirements ,
Opt-Outs ,
Physicians ,
Prescription Drugs ,
Required Documentation
On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more