Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th hearing in which officials from the Health Resources and Services Administration (HRSA), the Government Accountability Office (GAO), and the Department of Health … Read more
On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A common thread ran through the testimony of the three testifying witnesses: Erin Bliss, Assistant Inspector General with HHS-OIG; Dr. Debra Draper, Director of Health … Read more
In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government safety net programs share in 340B savings.” I reasoned that CMS already knew that “Medicare pays more for 340B drugs than the covered … Read more
Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But with another winter storm aimed at Washington, the hearing was cancelled. The cancellation came after witnesses had submitted their written testimony to subcommittee … Read more
With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.” … Read more
The year 2014 looks to be a year of major developments for the 340B Drug Discount Program. We have seen (1) a first in terms of the Health Resources and Services Administration (HRSA) imposing sanctions on audited entities, (2) written arguments in a lawsuit over the rules governing 340B access to orphan drugs, and (3) … Read more
Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on its completed audits of 340B covered entities through July 12, 2013. While the new rule does shed light on when 340B entities can purchase orphan … Read more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. Through the 340B Program, qualified safety net providers obtain deep discounts on outpatient … Read more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. Through the 340B Program, qualified safety net providers obtain deep discounts on outpatient … Read more
In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations. But then, as I posted late last month, a federal district court invalidated HRSA’s earlier rulemaking involving the 340B … Read more