June 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. … [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...]
Illinois Measure Will Bring Changes to 340B
State will require all eligible providers to enroll and forbid them from carving Medicaid outJune 5, 2012—Illinois is set to become the first state to require all of its 340B-eligible health care providers to participate in the federal drug discount program and then pass along to the state nearly all of their savings on 340B drugs administered or dispensed to Medicaid patients. Gov. Pat Quinn has said he will sign S.B. 2840, which state lawmakers sent to him on May … [Read more...]
340B Program Integrity Inquiry Continues
Members of Congress raise questions about a health system's and hospital's use of drug discountsMay 29, 2012—Members of Congress concerned about 340B oversight and program integrity are continuing their inquiries, turning their attention to a Georgia health system and an Alabama hospital. Two members of the House Energy and Commerce Subcommittee on Health recently sent a letter to the Health Resources and Services Administration (HRSA) asking it to audit … [Read more...]
OPA Publishes Two New Policy Releases
Updates non-discrimination policy and clarifies 340B eligibility within ACOsMay 25, 2012—The Office of Pharmacy Affairs (OPA) posted two new policy releases on its Web site yesterday. The first is an update to OPA’s non-discrimination policy requiring drug manufacturers to treat 340B providers the same as non-340B providers when manufacturers develop alternate allocation systems for drugs in short supply. OPA had issued a policy release on its … [Read more...]