Under the authority granted it by the Patient Protection and Affordable Care Act, the Health Resources and Services Administration (HRSA) is moving forward to laying the groundwork for imposing civil monetary penalties on manufacturers that overcharge covered entities under the
To Be or Not to 340B Blog
Legal Updates on the 340B Program
The "To Be or Not to 340B Blog," published by Quarles & Brady LLP, focuses on legal and regulatory developments related to the 340B Drug Pricing Program. The blog covers topics such as manufacturer rebate models, contract pharmacy restrictions, dispute resolution processes, and federal and state legislative changes impacting 340B covered entities. It analyzes the implications of policy shifts, litigation, and administrative rules on hospitals, health systems, and other eligible providers participating in the 340B Program. The blog also discusses enforcement actions, compliance challenges, and the evolving landscape of drug pricing and reimbursement under the 340B statute.
Latest from To Be or Not to 340B Blog - Page 5
Key Dates Approaching for Title X Family Planning Grantees in the 340B Program
Mark your calendars! Calling all Title X Family Planning clinics that participate in the 340B Program—recertification opens May 13, 2015 and that means 340B Participant Change Forms must be submitted before that date.
Online 340B Participant Change Forms take between…
340B Reform Legislation: Is Anything in the Offing?
As readers of this blog already know, manufacturers and some legislators believe the 340B program has grown too large, suffers from mission creep and needs reform. They argue that the program’s purpose is simply to reduce drug costs for the…
340B Program Covered Entities: Some Items for Your Worry List
When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them.
Orphan Drugs
There is a possibility that the orphan drug issue will be resolved unfavorably to…
The Message Is Clear from OPA Director Pedley
Covered entities should be constantly preparing for audit. That was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast at the recent Winter Conference of the 340B Coalition in San Francisco.…
340B Covered Entities: What to Expect When OPA Comes Knocking
Now that OPA has ramped up its audit activities, covered entities should not be surprised to find themselves on the receiving end of a 340B program review conducted by HRSA/OPA. The likelihood of this may be increased if the entity…
340B Program Participants: It’s Time to Ramp Up Compliance
340B covered entities need to revisit and perhaps ramp up their compliance efforts. The director of the Health Resources and Services Administration’s Office of Pharmacy Affairs has been very open in touting the fact that HRSA has invested in program…
340B and the OIG Work Plan
By Jaya White
OIG’s recently issued FY 2015 Work Plan has made duplicate discounts a new focus for FY 2015. OIG “will assess the risk of duplicate discounts for 340B-purchased drugs paid through Medicaid managed care organizations (MCOs) and describe States’ efforts to…
Controversy Continues to Swirl Around the 340B Program
Although the 340B program accounts for only two percent of over $300 billion in annual drug purchases in the US, there continues to be a lot of ink spilled over the question of whether the 340B program is serving its…
The Mega Rule is Dead! Long Live the Interpretive Guidance Documents!
HRSA/OPA announced the withdrawal of the so-called mega rule last November. This major piece of legislative rulemaking had been over four years in the works. The rule had spent the past six months at the Office of Management and Budget,…