March 13, 2013—The Health Resources and Services Administration (HRSA) has added additional detail to its policy on the criteria that hospitals that are not publicly owned or operated must meet to be eligible for 340B drug discounts. In its September 2011 report on 340B, the Government Accountability Office called on HRSA to further specify 340B eligibility criteria for such … [Read more...]
“Significant Changes” Coming to 340B Contract Pharmacy Registration
OPA holding webinar for covered entities on March 20March 12, 2013—The Office of Pharmacy Affairs (OPA) is making "significant changes" to the way that health care providers register contract pharmacies in the 340B drug discount program, the office says in an email that providers began receiving late last week. According to the notification, the changes, which were not described in the email, take effect with the next … [Read more...]
HRSA and OPA Brace for Automatic Spending Cuts
Sequestration's possible effect on 340B program still isn't knownMarch 5, 2013—The Health Resources and Services Administration (HRSA) will have its funding reduced by $605 million for the seven months remaining in fiscal 2013 after Congress and the White House failed to prevent government-wide automatic cuts from taking effect. The effects on the 340B drug discount program, if any, are not yet clear.[ms-protect-content … [Read more...]
340B Recertification Deadline Extended to March 15
Extra time granted to health and hemophilia centers and five other entity typesMarch 5, 2013—The Office of Pharmacy Affairs (OPA) has extended the 340B recertification deadline for community health centers, hemophilia treatment centers, and five other types of covered entities to March 15. OPA announced the extension on its 340B covered entity database homepage today.[ms-protect-content id="2799"] It said the extra time to recertify 340B eligibility … [Read more...]
Two New FAQs on 340B Group Purchasing Prohibition
OPA and Apexus both issue guidance addressing 340B drugs in mixed-use settingsMarch 1, 2013—The Office of Pharmacy Affairs (OPA) and Apexus/340B Prime Vendor Program (PVP) have each issued lengthy FAQs fleshing out OPA's new interpretation of the 340B statute's "GPO prohibition." The 340B law prohibits disproportionate share (DSH), children's, and free-standing cancer hospitals from participating in group purchasing organizations for 340B drugs, which … [Read more...]
Significant Number of Health Centers Missed 340B Recertification Deadline
OPA, meanwhile, drops 340B component from grantees' A-133 auditsFebruary 27, 2013—A "significant number" of community health centers did not recertify their eligibility for 340B drug discounts by a Feb. 25 deadline and might become ineligible for the program effective April 1, the National Association of Community Health Centers (NACHC) said yesterday. Recertification is part of the Health Resource Services Administration’s (HRSA) efforts … [Read more...]
A 340B Provider Audit by a Manufacturer Reaches Final Report Stage
Information released in response to questions about notice in Federal RegisterFebruary 22, 2013—One of the four audits of 340B covered entities being conducted by drug manufacturers has reached the final report stage, the Health Resources and Services Administration (HRSA) said yesterday. HRSA, responding to questions about a Federal Register notice yesterday regarding 340B audits and dispute resolution, said it has received six audit work plans from … [Read more...]