February 11, 2014—Halts or slowdowns in manufacturing to address quality problems are the leading immediate cause of drug shortages, especially among generic sterile injectable products, the Government Accountability Office (GAO) concluded in a long awaited report yesterday. It recommended that the Food and Drug Administration (FDA) strengthen its internal controls over its … [Read more...]
OPA Focusing on 340B Drug Pricing Transparency and Accuracy
Pedley describes various initiatives in talk to stakeholdersFebruary 7, 2014—The Health Resources and Services (HRSA) Office of Pharmacy Affairs (OPA) is developing ways to improve 340B pricing transparency and accuracy by drug manufacturers, OPA Director Cmdr. Krista Pedley said yesterday during the 340B Coalition winter conference in San Diego. Pedley addressed the gathering of more than 900 stakeholders remotely from HRSA … [Read more...]
“Vigilant” 340B Contract Pharmacy Oversight Is Critical, Pedley Says
OPA director issued statement in Washington and spoke via video at 340B conference in San DiegoFebruary 6, 2014—Contract pharmacies "can enable 340B covered entities to expand the type and volume of care they provide to vulnerable patient populations," the director of the Health Resources and Services Administration (HRSA) Office of Pharmacy (OPA) said today in a public statement, but audits have shown that entities' oversight of contract pharmacies "did not always meet … [Read more...]
OIG Issues Report on 340B Contract Pharmacy
Says findings suggest "lack of clarity" about patient definitionFebruary 5, 2014—Hospitals and health care centers vary in how they ensure compliance with 340B requirements for prescriptions filled at contract pharmacies, leading to different decisions about patient eligibility, the Department of Health and Human Services Office of Inspector concludes today in a much-anticipated report. … [Read more...]
CMS Delays Two-Midnight Rule Until After Sept. 30
Outpatient/inpatient designation has ramifications for 340B complianceFebruary 3, 2014—The Centers for Medicare and Medicaid Services (CMS) is once again delaying enforcement of its new "two-midnight rule" for deciding whether a patient is an inpatient for Medicare billing purposes. … [Read more...]
OIG Is Working on Three 340B Studies
Reports coming on contract pharmacy, manufacturer overcharges, passing savings to MedicareFebruary 3, 2014—The Department of Health and Human Services Office of Inspector General (OIG) plans to issue three important studies about the 340B program by this fall on contract pharmacy, overcharging by drug manufacturers, and passing savings along to Medicare. … [Read more...]
340B Ally Rep. Henry Waxman Retiring
Played a key role in program's creation, expansion, and oversightJanuary 30, 2014—Rep. Henry Waxman (D-Calif.), a driving force behind the 340B program's creation and one of its strongest defenders, has decided not to seek reelection in the fall and will retire at the end of this year. … [Read more...]