November 16, 2012—Expectations are growing that a bill may be introduced in Congress soon that would exempt certain generic injectable drugs from 340B drug discounts for possibly up to seven years. Rep. Bill Cassidy (R-La.), a member of the House Energy and Commerce Subcommittee on Health, has drafted drug shortage legislation that includes the 340B discount exemption and … [Read more...]
Suit Filed Over Reduced-Price Vaccines Through 340B Prime Vendor
For-profit clinic says voluntary discounts for safety-net providers are unfairNovember 14, 2012—A private, for-profit immunization clinic in Las Vegas has filed a federal lawsuit seeking to stop GlaxoSmithKline (GSK) from selling vaccines to a Nevada local public health entity at voluntarily discounted prices negotiated by the 340B Prime Vendor Program (PVP). In an Oct. 25 complaint filed in federal district court in Las Vegas, The Vaccine Center … [Read more...]
Mylan to Issue Refunds for 340B Overcharges
Providers, meanwhile, begin receiving overcharge refunds from GSKNovember 7, 2012—Drug manufacturer Mylan will soon be mailing refunds to 340B providers for overcharges on all products sold by its Dey Pharma subsidiary from late 1994 through late 2006, according to an announcement on the Office of Pharmacy Affairs (OPA) home page. In its statement on the OPA Web site, Mylan said the need to provide refunds to 340B covered entities "arises … [Read more...]
OPA Activates 340B Disaster Flexibilities Policy for N.Y. and N.J.
Notice now on Web site lacks earlier discussion of patient eligibilityNovember 7, 2012—The Office of Pharmacy Affairs (OPA) significantly revised its 340B "flexibilities during disasters" policy yesterday just four days after activating it in New York and New Jersey in the wake of Hurricane Sandy. Under the revised policy, it is no longer clear whether OPA will give hospitals, health centers, and other providers affected by the storm … [Read more...]
HRSA Requests Comments on 340B Reporting Requirements
Input Requested on Audits and Dispute Resolution Burdens, Due by Dec. 25October 26, 2012—HRSA has issued a request for comment on proposed forms relating to audits and dispute resolution. Earlier this year, HRSA launched a number of audits of covered entities to determine if they are in compliance with program requirements.[ms-protect-content id="2799"] The agency has also discussed the possibility of auditing manufacturers. The dispute resolution … [Read more...]
OPA Removes FAQs and Tightens Enrollment Rules
Latest Changes Follow Earlier Web Site RedesignOctober 26, 2012—After thoroughly overhauling its web site earlier this month, Office of Pharmacy Affairs (OPA) has continued to make changes to its online content. As reported earlier in The Monitor, the changeover occurred during the evening of Oct. 4-5. Initially, OPA included a newly-reorganized FAQ section. Several days after unveiling the new web site, however, OPA … [Read more...]
New 340B Claims Identification Code Is Cleared for Takeoff
NCPDP's advisory against usage expires on Oct. 15October 12, 2012—A voluntary embargo on the use of a new billing code to flag prescriptions filled with 340B discounted drugs ends early next week, clearing the way for the code's wide-scale implementation. Although the code, developed by the National Council for Prescription Drug Programs (NCPDP), has been available for over a year, NCPDP advised parties not to use it until … [Read more...]