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Set up 340B purchasing accounts with tighter wholesaler controls, cleaner split billing inputs, and invoice reconciliation that holds up under audit.
How covered entities use Medicaid exclusion files and claim-level controls to flag carve-out fee-for-service claims and avoid duplicate discounts.
Traceable 340B records aren't optional. They are what lets covered entities defend accumulations, replenishments, and claims when HRSA or manufacturers ask questions.
Build a 2026 340B policy framework for multi-site health systems that tracks eligibility logic, site controls, and cost report risk before audit trouble starts.
How orphan-drug exclusions work for RRCs, CAHs, and cancer hospitals, and what documentation supports compliant 340B purchasing.
Build a 340B savings reinvestment strategy that can survive eligibility shifts, board scrutiny, and compliance review while staying tied to community need.
How HRSA audit pressure, hospital eligibility shifts, and specialty pharmacy workflows collide inside today’s 340B compliance framework.
How HRSA ties 340B child-site eligibility to covered-entity operations and the records that usually make or break an audit.
How covered entities separate inpatient drug use from eligible outpatient 340B dispensing when patients move through admission, discharge, and follow-up.
How specialty and infusion pharmacy integration affects 340B compliance, patient support, and revenue integrity in the 2026 operating environment.
How HRSA registration, recertification, and change management work for 340B covered entities, with practical compliance advice grounded in current context.
How to build a 340B split-billing workflow that stands up to audit pressure, from charge capture through reconciliation and exception handling.
How to verify 340B ceiling prices, work pricing discrepancies, and document purchasing decisions without creating an audit problem.
340B Medicaid managed-care carve-in claims live or die on claim flags, state rules, and clean billing-status records that prevent duplicate discounts.
Inventory controls in 340B live or die on replenishment discipline, auditable records, and clean split-billing logic in 2026.
Manufacturer contract pharmacy restrictions turn on records, claim identification, and policy conflicts that covered entities can't afford to treat casually.
How patient status is established in 340B turns on documented care, outpatient drug use, and records that can survive audit review.
How split billing and replenishment work in 340B, with practical guidance on claim mapping, accumulations, and inventory records that can stand up to audit.
Medicaid exclusion file mistakes create duplicate discount risk. Here's what HRSA expects covered entities to document and reconcile.
Manufacturers' electronic portals like ESP redefine 340B oversight by verifying contract pharmacy claims and enforcing distribution limits.
HRSA expects 340B entities to maintain auditable dispensing, replenishment, and purchase-tracking systems that prove compliant virtual inventory use.
Covered entities face strict 340B documentation demands for insulin eligibility, contract pharmacy dispensing, and duplicate discount prevention.
How HRSA applies the 340B orphan drug exclusion for DSH hospitals and freestanding cancer centers, and what counts as eligible use.
How HRSA audits 340B covered entities for diversion, eligibility, and contract pharmacy compliance during site reviews in 2026.
Live headlines from leading pharma and regulatory news sources. Links open original articles.
Part of a wave of young biotechs employing AI to accelerate research, the company claimed in regulatory filings that its approach has the potential to "disrupt legacy drug discovery paradigms."
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in t
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
In a first, a subcutaneously administered RNA interference medicine crossed into the brain and plummeted levels of a protein implicated in the disease.
Rare Disease Regulatory Framework
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of d
On October 28, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to seek input related to the FDA’s Rare Di
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted d
Wall Street analysts believe Verastem's drug to now be "competitive" in what's quickly become one of the most active and crowded areas of oncology research.
Prosecutors say the company filled unnecessary prescriptions that fueled the opioid epidemic. A spokesperson for CVS said the company admitted to no wrongdoing and "strongly disagreed" with the case's
A 6% sell-off in J&J shares was viewed by one analyst as emblematic of broader market volatility. Elsewhere, Gilead is collaborating with Vir and a biotech's bid for a product expansion fell short
Discover why flow paths, tubing and connectors may limit your bioprocess performance
One lawyer involved noted how it's yet another example of Paragon and key investor Fairmount - which have helped transform the reputation for reverse mergers - quickly executing on a complicated deal.
An early data check showed the shot didn't delay tumor progression in a form of head and neck cancer, though BioNTech is holding out hope it might eventually extend survival.
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