Drug manufacturer Eli Lilly asked a 340B covered entity last week to promptly repay it for “duplicate 340B/Medicaid discounts” and evaluate all Lilly prescriptions that it or its contract pharmacies dispensed for the last three years.
Consultants and attorneys with
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Resolving 340B noncompliance can be a time-consuming task for 340B participants — and one of the greatest challenges in managing a 340B program. This guide outlines the five steps to successfully navigate resolving compliance issues requiring repayment to manufacturers, from discovery to resolution, and includes a solution to help streamline the refund process.
Step #1: Discovering 340B Program Noncompliance
Program noncompliance can be detected in four ways: self-audit, HRSA audit, manufacturer good faith inquiries or audits, and through normal day-to-day operations. Compliance issues are most commonly identified through self-audits conducted either by an internal audit department, pharmacy department, or an outside contractor hired by a covered entity.
“A compliance issue such as incorrect 340B accumulation quantities may be caused by systemic failures such as a data feed transmission error. In my experience as a 340B team member, we had analysts dedicated to reviewing specific program areas to monitor our program for noncompliance on an ongoing
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About a dozen people who advise, help run, or work at 340B covered entities are launching a nonprofit group, 340B Truth, to try to hammer out a covered entity consensus position on 340B reform and urge Congress to pass it
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A hearing is set for Thursday in the Louisiana House on a bill to stop drug manufacturers from impeding 340B covered entities’ use of contract pharmacies.
State Rep. Chris Turner (R) introduced House Bill 548, the Defending Affordable Prescription
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The U.S. Department of Health and Human Services Office of Inspector General said yesterday it has no comment on the status of referrals from the U.S. Health Resources and Services Administration to fine eight drug manufacturers for failing to offer
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The New York legislature on Monday passed a short-term state funding bill with $9 million in supplemental aid for Ryan White clinics that are losing 340B revenue due to the April 1 transfer of the state’s Medicaid managed care drug
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For 340B covered entities (CEs), a Health Resources and Services Administration (HRSA) audit is an inevitability. While you won’t be able to predict when HRSA comes calling, you can bank on sooner or later being one of the 200 CEs HRSA audits every year. That’s why Cloudmed recommends keeping your organization’s policies and procedures aligned with current 340B program guidance and expert interpretations. When the audit comes, you want to be one of the CEs with a clean outcome, not one of those saddled with findings that could jeopardize your program.
A critical component of a compliant 340B program is having your policies and procedures in good order before the audit. They must identify how you ensure key compliance measures are met for the 340B program, including patient definition, care setting, and other factors.
Beyond setting the applicable policies and procedures, you must ensure you
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New Mexico Gov. Michelle Lujan Grisham (D) signed a law April 7 to prevent pharmacy benefit managers and insurers from discriminating against 340B providers. The bill includes language that prohibits payers from reimbursing 340B covered entities at a lower rate
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A California state appeals court has affirmed a lower state court’s judgement that a 340B contract pharmacy overcharged the state Medicaid agency, Medi-Cal, nearly $2.5 million more than the pharmacy was entitled to receive for 340B drugs between May 2015
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