July 16, 2014—Rep. Henry Waxman (D-Calif.), one of the original authors of the bipartisan 340B drug discount program, reiterated his support for 340B in remarks earlier this week in Washington. … [Read more...]
Stakeholders Awaiting “Interpretive” 340B Orphan Drug Rule
Court filing reaffirms OPA director's July 14 announcementJuly 16, 2014—Federal government lawyers affirmed in a court filing late Monday night that the Health Resources and Services Administration intends "to issue a further interpretive rule or guidance" allowing 340B rural and cancer hospitals to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for … [Read more...]
Patients Tell How 340B Providers Cared for Them in Times of Great Need
Drug discount program "had a big hand in giving me [my life] back,” one saysJuly 16, 2014—Three uninsured patients described how 340B providers took care of them during a time of need in deeply emotional accounts yesterday at the 340B Coalition annual meeting in Washington. … [Read more...]
HRSA Publishing “Interpretative” 340B Orphan Drug Rule
Agency will pursue drugmakers that don't provide discounts to rural and cancer hospitalsJuly 14, 2014—The Health Resources and Services Administration is publishing a new 340B program rule in the Federal Register requiring drug manufacturers to give rural and free-standing cancer hospitals discounts on orphan drugs when used for non-orphan indications, Office of Pharmacy Affairs Director Cmdr. Krista Pedley said today. … [Read more...]
Senators Launch Inquiry Into Sovaldi’s Pricing
Drug's cost could dramatically increase federal spending, including health care for prisoners, they sayJuly 11, 2014—The Senate Finance Committee's Democratic chairman and a senior Republican member want Gilead Sciences to justify the $1,000-a-day price of its hepatitis C virus drug Sovaldi. … [Read more...]
Some Hospitals Report Glitch in 340B Registration
HRSA believes it has fixed the Issue, which is limited to certain web browsersJuly 8, 2014—The Health Resources and Services Administration says it believes it has resolved technical issues that prevented hospitals using older versions of the Internet Explorer web browser from registering parent and child sites in 340B due to their browser's incompatibility with HRSA's revamped hospital registration interface. … [Read more...]
HRSA Limits 340B Entities’ Ability to Dispute Adverse Audits
Will no longer issue preliminary reports to audited providersJuly 7, 2014—The Health Resources and Services Administration has truncated the 340B audit dispute process, ending one of two opportunities health care providers had to challenge adverse findings. … [Read more...]