Pharmacy

Representative Experience

• Represented the Missouri Pharmacy Association for more than 25 years.
• Counseled a Fortune 15 pharmacy services company on prescription drug coverage, billing and reimbursement, pharmacy licensing, Medicare Part D, and health plan coordination of benefits.
• Advised pharmacies on privacy compliance under the Health Insurance Portability and Accountability Act (HIPAA), and Health Information Technology for Economic and Clinical Health Act (HITECH).
• Advised a specialty pharmacy on enrolling in all 50 states and the District of Columbia Medicaid programs, as well as ongoing compliance.
• Obtained pharmacy licenses in all 50 states and the District of Columbia.
• Negotiated network payer agreements and provided strategic legal counsel when disputes arose between payers and a specialty pharmacy.
• Facilitated initial licensure for pharmacies with state boards of pharmacy.
• Submitted pharmacy change of location applications to boards of pharmacy in 50 states and Washington, DC, and strategized timing to minimize potential lapses in licensure.
• Prepared pharmacy change of location notifications to the Drug Enforcement Administration (DEA) and state agencies handling controlled substance registration.
• Advised pharmacies on change of pharmacist-in-charge notifications, including preparing applications and compiling documentation.
• Advised pharmacies on legal issues related to the customer outreach programs, including the Telephone Consumer Protection Act (TCPA).
• Appealed Medicare and Medicaid claims denials in order to obtain payment for specialty medications.
• Successfully represented a national retail pharmacy chain in state Medicaid agency audits that resulted in reimbursement savings of several million dollars.
• Drafted and negotiated limited distribution pharmacy agreements, discount agreements, pharmacy services agreements, and patient assistance program agreements between a specialty pharmacy and pharmaceutical manufacturers.
• Counseled a specialty pharmacy on state Prescription Drug Monitoring Program reporting requirements, exemptions, and waivers.
• Developed Medicaid program compliance guidance for a specialty pharmacy.
• Reviewed, revised and developed 340B federal drug pricing program policies and procedures for a health clinic with in-house and contract pharmacies.
• Consulted with providers on state and federal controlled substance registration issues and compliance.
• Advised a pharmacy on security requirements for transporting drugs between pharmacy locations.
• Successfully represented pharmacies in Board of Pharmacy proceedings in multiple jurisdictions.
• Defended pharmacies accused of dispensing errors, including alleged misfills, delays, wrongful death, and negligent failure to warn claims.
• Advised and successfully defended specialty pharmacies on issues related to their right to make decisions to dispense or not dispense medications.
• Defended pharmacists and pharmacies in reimbursement and licensing disputes with the government.
• Successfully represented a pharmacy in a putative class action alleging the pharmacy placed pre-recorded calls without consent, in violation of the TCPA, and obtained summary judgment under the emergency purpose exception.
• Successfully defended a pharmacy benefit manager after it terminated a supplier where an investigation showed the supplier was waiving copayments, resulting in a favorable defense verdict.
• Obtained summary judgment on behalf of a mail-order pharmacy in a case alleging significant medical and personal injuries resulting from a patient’s failure to refill medications.
• Obtained a significant victory in a case filed by a doctor and his patients against our client, a pharmacy benefit manger and its specialty pharmacy.
• Successfully and strategically expanded specialty pharmacy provider to operate in all 50 states.
• Drafted and negotiated contractual arrangements of all types, including limited distribution pharmacy agreements, data sales agreements, discount agreements, pharmacy services agreements, and patient assistance program agreements between specialty pharmacy and pharmaceutical manufacturers.
• Successfully represented specialty pharmacy providers in administrative hearings involving adverse audit findings in Medicare and Medicaid billing matters.
• Assumed the role of outside general counsel for pharmaceutical services provider during a period of short staffing in the legal department.
• Reviewed and negotiated contracts for CRO services, pharmacovigilance services, REMS services, HUB/commercial services, nursing services, and Patient Assistance Program services.
• Represented a PBM in a dispute with a client regarding the alleged wrongful processing and payment of certain compound prescription drugs in federal court in Maryland. After negotiating an agreement to limit discovery, and prior to filing dispositive motions, the parties reached a favorable settlement.
• Prevailed for pharmacy benefit manager in massive multi-district litigation, obtaining both a dismissal with prejudice and an important decision defending the use of mail-order pharmacies to deliver medications.
• Represented infusion care provider and specialty pharmacy in dispute with insurance company over wrongful denial and underpayment of insurance claims.