December 9, 2010—The U.S. House gave final approval to legislation today reversing the provision in health care reform that denied children’s hospitals access to 340B discounts on so-called “orphan drugs” for their patients, many of whom require expensive, long-term or complicated care.
The Senate passed the measure late yesterday. President Obama has indicated that he will sign the bill, H.R. 4994.
In addition to ending the ban for children’s hospitals, the measure makes clear that such hospitals are entitled to retroactive relief if they were denied 340B discounts.
Focus Turns to Rural and Cancer Hospitals
Hospital groups are continuing to urge Congress to repeal a related ban on discounts for orphan drugs affecting rural and free-standing cancer hospitals that gained eligibility for 340B under health care reform.
“These institutions also spend a significant portion of their drug budget on these therapies,” said Safety Net Hospitals for Pharmaceutical Access (SNHPA) Executive Director Ted Slafsky. “It is imperative that they be able to access affordable medications for their patients.” SNHPA represents more than 600 hospitals enrolled in 340B.
Several manufacturers recently began denying 340B pricing on orphan drugs to these institutions and children’s hospitals as well. SNHPA has asked these companies to resume the discounts pending guidance from federal health officials, which is reportedly forthcoming.
Pharmaceutical Research and Manufacturers of America (PhRMA) released a statement yesterday saying it did not oppose lifting the ban on orphan drug discounts for children’s hospitals. BIO, the trade group for biotechnology companies, had no comment on the legislation.
The National Association of Children’s Hospitals (NACH) issued a statement in response to the Senate’s action late yesterday, NACH President and CEO Lawrence McAndrews noted that his group’s members “use most of the 347 approved orphan drugs on a daily basis.” He said they are used to treat conditions including cystic fibrosis, pediatric cancers, respiratory distress in premature infants, juvenile arthritis and cerebral palsy.
“Allowing children’s hospitals to continue to purchase orphan drugs at discounted prices will help protect access to life-saving treatments for children,” said McAndrews.