Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more
3/16/2017
/ Affordable Care Act ,
Drug Pricing ,
Executive Orders ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Repeal ,
Section 340B ,
Trump Administration
Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more
The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more
Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more
On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date,...more
In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...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...more
Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...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...more
For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....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...more
In a blow to government efforts to regulate the 340B Drug Discount Program, U.S. District Judge Rudolph Contreras has ruled that HRSA lacks regulatory authority to promulgate regulations expanding access to 340B discounts for...more
On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...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,...more
For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers.
As we previously wrote, Senator Grassley has been among the most vocal of critics in...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...more
In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more
Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more
After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more