HHS de­fends ex­panded 340B drug dis­counts

Modern Healthcare - - NEWS - By Jaimy Lee

HHS is stick­ing to its po­si­tion that the health­care re­form law re­quires dis­counts on ex­pen­sive or­phan drugs de­spite the drug in­dus­try’s le­gal vic­tory on the is­sue last month.

In a court fil­ing last week, HHS said it is mulling whether to ap­peal a federal rul­ing strik­ing down or­p­hand-rug reg­u­la­tions on the federal 340B drug dis­count pro­gram, or else is­sue guid­ance that would re­place the rule and com­pel drug­mak­ers to pro­vide the dis­counts. The Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­ica, a trade group for the drug in­dus­try, ar­gued in a law­suit last year that HHS mis­in­ter­preted the drug dis­count pro­vi­sion in the Pa­tient Pro­tec­tion and Af­ford­able Care Act and over­stepped its rule­mak­ing author­ity.

Or­phan drugs, des­ig­nated to treat con­di­tions or dis­eases that af­fect fewer than 200,000 Amer­i­cans, are some of the prici­est drugs on the mar­ket. But it’s com­mon for drug­mak­ers to seek broader in­di­ca­tions for these drugs.

Safety net hos­pi­tals want the govern­ment to keep its cur­rent or­phan-drug pol­icy “so ru­ral and cancer hos­pi­tals are not faced with sig­nif­i­cant drug price in­creases,” said a spokesman for Safety Net Hos­pi­tals for Phar­ma­ceu­ti­cal Ac­cess. With the re­cent and rapid ex­pan­sion of the 340B pro­gram, which pro­vides 20% to 50% mark­downs on out­pa­tient drugs, drug­mak­ers ar­gue that some par­tic­i­pat­ing providers and phar­ma­cies are abus­ing the pro­gram by not us­ing 340B sav­ings or rev­enue to im­prove care for poor, unin­sured and in­di­gent pa­tients as in­tended. On June 5, Ge­nen­tech stopped pro­vid­ing dis­counts on

It’s com­mon for drug­mak­ers to seek broader in­di­ca­tions for or­phan drugs.

or­phan drugs for the four types of par­tic­i­pat­ing hos­pi­tals—free-stand­ing cancer cen­ters, crit­i­cal-ac­cess hos­pi­tals, ru­ral re­fer­ral cen­ters and sole com­mu­nity hos­pi­tals—that gained ac­cess to 340B un­der the re­form law.

The judge’s rul­ing could af­fect whether HHS’ Health Re­sources and Ser­vices Ad­min­is­tra­tion can move for­ward this month with plans to re­lease new pro­posed reg­u­la­tions sent to the Of­fice of Man­age­ment and Budget for re­view in May. “HRSA is as­sess­ing the im­pact of the re­cent U.S. District Court rul­ing on the pro­posed 340B pro­gram om­nibus rule,” a HRSA spokesman said.

The rul­ing also could mean that fewer providers en­roll or re­main en­rolled in the pro­gram. The Safety Net Hos­pi­tals for Phar­ma­ceu­ti­cal Ac­cess spokesman said that with­out the dis­counts on or­phan drugs, some hos­pi­tals may re­con­sider 340B par­tic­i­pa­tion.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.