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In Brief: A Digest of Pharmacy Projects

Client Success
  • 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.
  • Assisted in the purchase and sale of pharmacies.
  • Successfully represented pharmacies in Board of Pharmacy proceedings in multiple jurisdictions.
  • Litigation
  • 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.

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