March 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. … [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...]
HRSA Issues Guidance on Billing Medicaid for 340B Drugs
Entities need to tell states when their inability to buy at 340B means rebate is availableFebruary 20, 2013—Providers that have decided to use 340B-discounted drugs for their Medicaid patients need to have a mechanism in place to let state Medicaid officials know whenever they are unable to purchase a drug at its 340B price, the Health Resources and Services Administration (HRSA) says in a recent guidance document. The new notification requirement, announced … [Read more...]
Drug Industry and Allied Groups Want Rollback of 340B
Report says discounts should be more narrowly focused toward the uninsured poorFebruary 13, 2013—A coalition representing drug manufacturers, pharmacy benefit managers, private practice oncologists, and independent pharmacies issued a report yesterday on hospital participation in the 340B drug discount program, arguing that hospitals have strayed from what the groups maintain is 340B's purpose of helping the uninsured poor "gain better access to … [Read more...]
HRSA Clarifies Policy on 340B Hospitals’ Use of GPOs
Gives hospitals 60 days to change their drug purchasing methodologiesFebruary 8, 2013—Hospitals that use 340B covered outpatient drugs in departments that treat both inpatients and outpatients cannot buy drugs for such units at group purchasing organization (GPO) prices and then replenish their inventories with drugs bought at 340B prices, the Health Resources and Services Administration (HRSA) said yesterday. Hospitals have used this … [Read more...]