Modern Healthcare - - LATE NEWS -

The Medi­care Pay­ment Ad­vi­sory Com­mis­sion last week voted 15-0 to rec­om­mend that Congress en­act new drug re­im­burse­ment laws through sev­eral pro­pos­als that would de­crease Medi­care spend­ing by as much as $750 mil­lion in the first year of im­ple­men­ta­tion and $5 bil­lion over five years. But drug­mak­ers and providers have pre­vi­ously and suc­cess­fully lob­bied hard against any such changes to the Medi­care Part B pro­gram. MedPAC was sug­gest­ing cut­ting whole­sale prices and ne­go­ti­at­ing drug prices to help curb the ris­ing drug costs for the Part B pro­gram, which hit $26 bil­lion in 2015.

A bi­par­ti­san House bill is try­ing to stop drug­mak­ers from block­ing generic and biosim­i­lar com­peti­tors. The bill could save an es­ti­mated $5.4 bil­lion a year in re­duced drug costs by clos­ing a reg­u­la­tory loop­hole, ac­cord­ing to Premier, a Char­lotte, N.C.-based group pur­chas­ing or­ga­ni­za­tion and per­for­mance im­prove­ment com­pany that sup­ported the bill. Some drug­mak­ers have barred com­peti­tors from ac­cess­ing prod­uct sam­ples they need to de­ter­mine if their prod­ucts are equiv­a­lent to the brand-name ver­sion. The Food and Drug Ad­min­is­tra­tion re­quires generic- and biosim­i­lar-drug mak­ers to con­duct those stud­ies be­fore their drugs are ap­proved.

A Ge­or­gia jury has awarded more than $20 mil­lion to a re­tired kinder­garten teacher and her hus­band who claimed that drug­maker Akorn failed to in­clude a warn­ing on a pre­scrip­tion drug la­bel that it would harm­fully in­ter­act with an­other drug she was tak­ing. Ann Pope lapsed into a coma and suf­fers from per­ma­nent cog­ni­tive dam­age af­ter she was given methy­lene blue dur­ing a surgery at Perry (Ga.) Hospi­tal. The Food and Drug Ad­min­is­tra­tion in 2011 warned that the drug could cause se­ri­ous cen­tral-ner­vous sys­tem re­ac­tions when used with a drug she was tak­ing. Ac­cord­ing to court doc­u­ments, Akorn knew about that FDA warn­ing.

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