February 8, 2013—Sixteen out of the 18 federal 340B covered entity audits completed thus far found no violations of program requirements, the Health Resources and Services Administration (HRSA) reported today. Two audits—of a Texas health center and a Florida cancer hospital—found inaccuracies in the providers' entries in the 340B covered entity database, HRSA's Office of … [Read more...]
HRSA Issues Two 340B Policy Releases
Guidance documents address GPO prohibition and Medicaid exclusion fileFebruary 7, 2013—The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) issued two 340B program policy releases this morning regarding (1) the prohibition against obtaining "covered outpatient drugs" through a group purchasing organization (GPO) for disproportionate share (DSH), children's, and free-standing cancer hospitals and (2) the use of … [Read more...]
OPA Asks 340B Hospitals About Botox Use
Known for smoothing wrinkles, drug is widely prescribed for multiple medical conditionsFebruary 7, 2013—The Office of Pharmacy Affairs (OPA) sent letters to 340B hospitals in late January requesting details about their use of the Allergan drugs Botox and Botox Cosmetic. Although Botox is perhaps best known for its cosmetic use, it is widely used medically to treat specific neuromuscular conditions affecting the upper limbs, eyes, and neck. … [Read more...]
HRSA Sends 340B Orphan Drug Final Rule to OMB for Clearance
Timetable for such reviews suggests regulation might be published by May 1February 4, 2013—The Health Resources and Services Administration (HRSA) has sent the White House Office of Management and Budget (OMB) its draft final regulation to clarify the Affordable Care Act’s (ACA) restriction on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under health care reform. OMB's Office of Information and Regulatory … [Read more...]
Lawmakers Seek Information From HRSA About 340B Audits and Recertification
Agency "turned a blind eye" to ineligible providers, they assertFebruary 1, 2013—Six Republican members of Congress asked the Health Resources and Services Administration (HRSA) late yesterday for details about its audits and recertification of 340B covered entities. In a Jan. 31 letter, the lawmakers—Sens. Chuck Grassley (Iowa), Orrin Hatch (Utah), Lamar Alexander (Tenn.) and Michael Enzi (Wyo.) and Reps. Joe Pitts (Pa.) and Bill … [Read more...]
340B Providers Losing an Ally in Senator Harkin
Program champion will retire in 2014January 30, 2013—Sen. Tom Harkin (D-Iowa), who has championed health care safety-net issues as the chairman of two important Senate committees, has decided not to seek reelection in 2014. Senator Harkin, 73, announced his decision on Jan. 26, explaining that after serving 40 years in Congress in both the House and Senate, "I just feel it's someone else's turn." … [Read more...]
340B Health Center Recertification Will Begin on Feb. 5
Failure to recertify will lead to loss of discounts, group reminds its membersJanuary 18, 2013—Federally qualified health centers (FQHCs) will have three weeks beginning Feb. 5 to recertify their eligibility for 340B drug discounts, the National Association of Community Health Centers (NACHC) is reminding its members. NACH posted the alert on its blog on Jan. 18. … [Read more...]