August 14, 2013—Rural and cancer hospitals will get their first hands-on experience complying with the new 340B orphan drug exclusion regulation beginning next Monday, the start of the four-week period during which they and all other 340B hospitals must recertify their eligibility for the drug discount program. … [Read more...]

August 9, 2013—More than 100 members of Congress (84 representatives and 29 senators) have signed letters to leaders of their respective chambers expressing their "bipartisan support" for the 340B drug discount program. … [Read more...]

August 2, 2013—Sen. Orrin Hatch (R-Utah) has sent a letter to HRSA Administrator Mary Wakefield saying the agency's 340B orphan drug exclusion final regulation is "incorrectly interpreting the law" and diminishes incentives for orphan drug development. … [Read more...]

August 1, 2013—Sen. Charles Grassley (R-Iowa) sent a letter yesterday to Walgreens requesting detailed information about its participation in the 340B program as a contract pharmacy, including its financial arrangements with covered entities. … [Read more...]

Earlier today, HRSA published online its long-awaited final regulation to implement the 340B “orphan drug exclusion,” which limits 340B-purchasing for free-standing cancer hospitals, critical access hospitals, sole community hospitals, and rural referral centers participating in the 340B drug discount program. The final regulation mirrors HRSA’s May 2011 proposed rulemaking in … [Read more...]

July 17, 2013—The White House Office of Management and Budget (OMB) has finished its review of the long-awaited final regulation to implement health care reform’s partial limit on 340B discounts for orphan drugs, presumably clearing the rule for publication in the Federal Register. … [Read more...]

July 17, 2013—The Health Resources and Services Administration (HRSA) has released 16 more summaries of the findings from its audits of 340B covered entities in 2012. … [Read more...]