NAMD: Breakthrough Pathways In 'Cures' Draft Pose Safety Concerns For Medicaid Patients

State Medicaid directors complain that proposals in House lawmakers' draft Cures bill to expedite approval of drugs and devices through “breakthrough” designations could pose safety risks for Medicaid patients. The National Association of State Medicaid Directors wrote to House Energy and Commerce Chair Fred Upton (R-MI) and Ranking Democrat Frank Pallone (NJ) last week that “lowered evidentiary standards” for FDA approval would make Medicaid patients, who tend to be “sicker and frailer” than other populations, a “captive market” for adverse...