We’re Here To Answer Your 340B Questions
Beyond standard diversion and duplicate discount checks, what advanced audit preparedness strategies are essential to pass a high-stakes HRSA review on patient definition, particularly for complex referral streams?
Passing a HRSA audit hinges on demonstrating defensible, iron-clad patient definition compliance, especially within mixed-use areas and off-site clinics. Cooper Strategy implements a proprietary pre-audit methodology that simulates HRSA’s rigorous patient-by-patient tracking to identify and remediate patient eligibility exceptions, including scrutinizing claims with a tenuous medical record link to the covered entity. We focus on hardening the entire audit trail—from provider documentation in the EHR to the TPA claims match—ensuring total process integrity for Cooper Strategy’s clients.
How can a Disproportionate Share Hospital (DSH) proactively mitigate the heightened risk of manufacturer-initiated 340B contract pharmacy restrictions and maintain program integrity?
The current regulatory ambiguity necessitates a proactive defense posture focused on the patient definition integrity across all dispensing modalities. Cooper Strategy advises DSH clients on establishing an auditable chain of referral capture documentation and leveraging internal specialty pharmacies where economically feasible. This approach creates an independently controlled dispensing channel, substantially insulating the covered entity from unilateral manufacturer-imposed dispensing limitations, an increasingly critical defense of 340B program viability.
What is the optimal strategy for a covered entity to "carve-in" Medicaid billing compliantly while rigorously preventing duplicate discounts and maximizing 340B capture?
The decision to carve-in Medicaid is a complex financial and compliance calculation. The optimal strategy, which Cooper Strategy helps clients implement, involves a sophisticated split-billing engine configuration, precise maintenance of the Medicaid Exclusion File (MEF), and a robust reconciliation process to prove to HRSA that a manufacturer is never rebated for a drug already purchased at the 340B ceiling price. Cooper Strategy ensures this delicate balance is managed to compliantly maximize savings potential without incurring manufacturer repayment liabilities.
Given the increased scrutiny on the use of Third-Party Administrators (TPAs), how can a covered entity ensure continuous, independent oversight of TPA performance to safeguard compliance?
Reliance on a TPA does not absolve the covered entity of responsibility for 340B compliance; it heightens the need for active, documented oversight. Cooper Strategy helps clients establish a robust governance framework that includes a quarterly TPA performance scorecard, independent transaction testing outside the TPA system, and validation of the TPA’s change management process. This ensures Cooper Strategy’s clients maintain ultimate, auditable control over their entire 340B transaction stream.
What are the legislative and regulatory forecasting implications of current manufacturer litigation on the long-term financial stability of the 340B program for large hospitals?
Current manufacturer-led litigation and regulatory challenges create significant program uncertainty, requiring covered entities to develop dynamic financial models. Cooper Strategy provides critical, forward-looking intelligence on potential HRSA rulemakings and court decisions, enabling clients to model worst-case scenarios and develop contingency strategies, thus protecting the substantial financial benefit derived from the program and allowing for long-term strategic planning.
When should a covered entity strategically transition from a third-party contract pharmacy network to developing an in-house specialty pharmacy to optimize 340B savings on high-cost therapies?
The transition to an in-house specialty pharmacy is a capital-intensive decision driven by the rising spend on high-cost, limited distribution specialty drugs. Cooper Strategy conducts a specialized ROI analysis that considers the CE’s patient volume, payer mix, and the complexity of managing specialty drug accreditation and inventory. We advise that the transition is strategically optimal when the captured 340B savings significantly outweigh the operational complexity and cost, giving Cooper Strategy’s clients a powerful tool for patient care.
How does the Orphan Drug Exclusion (ODE) impact non-hospital covered entities, and what sophisticated mechanisms must be in place to ensure compliance across all dispensing locations?
The ODE’s applicability to certain non-hospital covered entities adds a layer of complexity to purchasing and dispensing, as it restricts 340B pricing for specific orphan drugs. Cooper Strategy implements an advanced formulary and inventory management solution that segment ODE-eligible covered entities’ purchasing to exclude the discounted orphan drugs, while ensuring that the covered entity can still procure these drugs via non-340B channels when necessary for patient care, thereby guaranteeing seamless compliance.
What are the key considerations for achieving 340B eligibility at newly acquired off-site outpatient facilities, especially in demonstrating the requisite relationship to the main covered entity?
Establishing 340B eligibility for a newly acquired off-site clinic is a compliance-heavy undertaking that requires meticulous adherence to HRSA’s OPAIS requirements. Cooper Strategy guides clients through the complex process of verifying listing on the Medicare Cost Report (MCR), ensuring that facility costs and patient revenue are correctly captured, and submitting the necessary documentation to HRSA for OPAIS registration—a critical step that Cooper Strategy manages to lock in eligibility from the earliest possible date.ds a layer of complexity to purchasing and dispensing, as it restricts 340B pricing for specific orphan drugs. Cooper Strategy implements an advanced formulary and inventory management solution that segment ODE-eligible covered entities’ purchasing to exclude the discounted orphan drugs, while ensuring that the covered entity can still procure these drugs via non-340B channels when necessary for patient care, thereby guaranteeing seamless compliance.
How can a covered entity utilize the 340B program revenue to quantifiably expand patient services to meet the program's legislative intent and prepare for potential transparency mandates?
The legislative intent requires that 340B savings be used to stretch federal resources to benefit vulnerable patients. Cooper Strategy assists clients in developing a formalized, quantifiable Community Benefit Report that transparently tracks 340B revenue utilization toward uncompensated care, patient assistance programs, and expanded clinical services. This proactive, data-driven transparency helps Cooper Strategy’s clients demonstrate their commitment to the program’s mission and anticipate future regulatory reporting requirements.
Does Cooper Strategy integrate with specialized electronic health record (EHR) and inventory systems to ensure a singular source of truth for all 340B transactions?
Yes, Cooper Strategy specializes in complex integration architecture, recognizing that a compliant and optimized 340B program hinges on flawless data interoperability between the EHR, the wholesaler, and the TPA. We employ a vendor-agnostic approach, designing customized interface solutions that guarantee accurate capture of prescriber, location, and patient eligibility data at the point of prescribing, ensuring a singular, auditable source of truth for all 340B transactions managed by Cooper Strategy.