November 9, 2010—The Republican takeover of the U.S. House last week could slow down efforts to expand 340B discounts to the inpatient setting. Its effect, however, on efforts to reverse a provision in reform barring newly eligible 340B hospitals from buying orphan drugs at 340B-discounted prices is less clear.
As of Nov. 9, the GOP had 239 seats in the House to the Democrats’ 189 with seven races still undecided. Democrats retained control of the Senate but lost six seats to the GOP. Alaska’s Senate race is still undecided but Sen. Lisa Murkowski, the Republican incumbent running as a write-in candidate, is expected to be declared the winner. If that occurs, the Democrats will have 53 Senate seats to the GOP’s 47. Overall, Congress will have more than 90 new members next year.
Lame Duck Session
Congress returns for a post-election lame duck session on Nov. 15. It is unclear if lawmakers will be able to agree on much more than a temporary funding measure called a continuing resolution to keep the government running. Under Democratic control earlier this year, the House passed legislation twice to lift the orphan-drug ban but it never gained traction in the Senate. A group of Republican senators led by Scott Brown (R-Mass.) recently introduced a bill, S. 11, to repeal the ban for children’s hospitals, but in the current political climate its fate is uncertain.
Other legislation proposed by House Democrats to establish a limited inpatient drug discount program called 340B-1 is now very much up in the air.
If Congress passes the continuing resolution, the Office of Pharmacy Affairs’ budget will remain stuck at its fiscal 2010 $2.2 million level. OPA officials have warned that they will not implementa new 340B dispute resolution process or another to impose civil monetary penalties on drug manufacturers that knowingly overcharge 340B providers if they do not get additional funding. Public comments to help guide OPA’s drafting of those rules are due Nov. 19.
OPA began the rulemaking process for those two provisions because Congress gave it deadlines to do so in health care reform. If no additional money to implement reform is coming from Congress, it is unclear when or even if the office will begin drafting other 340B-related rules pursuant to the Affordable Care Act.
De-Funding of Reform Expected
With President Obama still in office and the Senate still under Democratic control, total repeal of health care reform is unlikely. House Republicans, however, are widely expected to try to deny funding to various aspects of reform. Whether 340B-related elements will be included remains to be seen.
One element likely to survive is the congressionally mandated study of 340B by the Government Accountability Office (GAO). Requested by Sens. Orrin G. Hatch (R-Utah) and Mike Enzi (R-Wyo.), the study will address whether 340B should be expanded, whether mandatory sales of certain products by the 340B program could hinder patients’ access to those therapies through any provider, and whether income from the 340B program is being used by 340B providers to further the program’s objectives.
GAO staff members have already interviewed many 340B stakeholders and are currently collecting information about the program.