June 28, 2012—Human protein products manufacturer Octapharma USA has announced an initiative to make its octagam 5% immune globulin intravenous (IGIV) therapy for primary immune deficiency widely available to 340B covered entities. "Octapharma is committed to providing therapies to treat life-threatening conditions to all patients, including those who are treated in … [Read more...]
Fla. Lifts Inventory Barrier to 340B Contract Pharmacies
New law will end requirement for physically separate drug stocksJune 21, 2012—Effective July 1, Florida 340B contract pharmacies will no longer have to keep physically separate inventories for 340B and non-340B drugs, under legislation passed by state lawmakers and signed by Gov. Rick Scott (R) this spring.[ms-protect-content id="2799"] The Florida Hospital Association estimates that by allowing contract pharmacies to keep track of 340B … [Read more...]
Bristol-Myers Squibb Ends Bulk Replenishment for Plavix
Widely-used anti-coagulant came off patent on May 17June 21, 2012—Bristol-Myers Squibb's (BMS) patient assistance foundation has notified hospitals that the drug manufacturer's blockbuster anti-coagulant Plavix is no longer available for bulk replenishment. Plavix also is no longer listed on the foundation's Web site among the medications available at no cost to low-income and uninsured individuals.[ms-protect-content … [Read more...]
HRSA Publishes More Information About 340B Audits
Document does not include audit protocol or discuss appeals of adverse determinationsJune 21, 2012—The Health Resources and Services Administration (HRSA) has issued a document to give 340B stakeholders a clearer picture of what it is looking for when it audits a 340B covered entity and its overall process for conducting such reviews. The document, however, does not include the actual protocol that HRSA is using to conduct the audits. [ms-protect-content … [Read more...]
Senate Panel Once Again Approves 0.1% Fee on 340B Drug Purchases
Urges HRSA to release information about audit processes "as soon as possible"June 15, 2012—The Senate Appropriations Committee has passed a fiscal 2013 spending bill for federal health care programs that would maintain the Office of Pharmacy Affairs' (OPA) appropriation at its current $4.47 million and supplement it with another $6 million from a 0.1 percent user fee on 340B drug purchases. In the report that accompanies the bill, the committee … [Read more...]
HRSA Seeking Contractor to Advise OPA on 340B Audits
Duties will include providing feedback on issues identified during covered entity compliance reviewsJune 14, 2012—The Health Resources and Services Administration (HRSA) is seeking a contractor to review the Office of Pharmacy Affairs' (OPA) 340B covered entity audit reports and "provide feedback on any identified issues," according to a June 11 notice posted on the Federal Business Opportunities Web site. In addition, the "pre-solicitation" notice states that the … [Read more...]
Emails Shed Light on How 340B Inpatient Expansion Was Dropped From Health Reform
February 2010 exchange between PhRMA execs describe phone call that apparently sealed the dealJune 12, 2012—White House and pharmaceutical industry communications released by House Energy and Commerce Committee Republicans late last week shed light on the negotiations over closing the Part D "donut hole" and expanding the 340B drug discount program in the days leading up to final passage of the Affordable Care Act (ACA) in early 2010. According to a Feb. 21, 2010 … [Read more...]