December 16, 2011—Congressional negotiators last night approved a $1 trillion fiscal year 2012 spending agreement for much of the federal government that level-funds the Office of Pharmacy Affairs (OPA) at its current $4.48 million. The measure does not include a proposed user fee that was expected to raise an additional $5 million to finance 340B program integrity … [Read more...]
OPA-CMS Webinar Focuses on Preventing 340B Duplicate Discounts
Pedley reminds providers of their responsibility to keep OPA database up to date.December 15, 2011—With 340B covered entity audits just over the horizon, providers that use 340B drugs for Medicaid patients should double-check the accuracy of their information in the Office of Pharmacy Affairs (OPA) database lest they find themselves on the hook for a duplicate discount violation, the office's director recommended during a recent webinar. Also, auditors … [Read more...]
Sanofi Discontinues Its Institutional Patient Assistance Program
Providers says IPAP's demise will strain their budgets and could compromise patient care.December 9, 2011—Safety-net hospitals and free and charitable clinics say they are scrambling to replace formerly free bulk supplies of Sanofi U.S. medications, including the widely used anticoagulant Lovenox (enoxaparin), following the drug manufacturer's mid-November notice that it is discontinuing its entire institutional patient assistance program (IPAP) at the end of … [Read more...]
Senate Committee Seeks Answers on Drug Shortages
340B's role raised again, just as it was during House session a week earlier.December 8, 2011—A second congressional committee in as many weeks has heard expert testimony on what is causing critical shortages of generic injectable drugs, including whether 340B drug discounts are part of the problem and, if so, to what degree. The Dec. 7 Senate Finance Committee hearing came just eight days after the one held by the House Oversight and Government … [Read more...]
Experts Link Medicare Reimbursement to Drug Shortages
Witnesses at House hearing disagree over whether 340B contributes to the problem.December 2, 2011—Witnessesses testifying before a U.S. House subcommittee largely agreed that Medicare pharmacy reimbursement is one of the core reasons behind critical shortages of generic injectable drugs, but they differed over whether 340B discounts are a factor. [ms-protect-content id="2799"]The House Oversight Subcommittee on Health Care held the Nov. 30 session to … [Read more...]
HRSA Issues Three 340B Policy Clarifications
Documents cover manufacturer audits, allocation procedures during shortages, and penny pricing.November 22, 2011—The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued three documents late yesterday clarifying its policies in three areas: manufacturer audits of 340B covered entities, procedures for allocating 340B-priced drugs in short supply, and the office's "penny pricing" policy when the statutory 340B ceiling price formula … [Read more...]
Deficit Reduction Supercommittee Falters
Funding for 340B program integrity efforts is still up in the air.November 22, 2011—The joint congressional committee tasked with developing a $1-billion-plus deficit reduction plan announced yesterday that it had failed to reach a deal. What the collapse of the Joint Select Committee on Deficit Reduction means for the 340B program is not completely clear. The panel's failure to reach a bipartisan consensus triggers approximately $1.2 … [Read more...]