Arielle T. Miliambro

Clients turn to Arielle Miliambro for creative, practical solutions to their legal issues. Arielle is a Partner in the Healthcare & Life Sciences Departments with a focus on regulatory and transactional law. She represents pharmacies, diagnostic laboratories, practitioners, manufacturers, and healthcare technology and management companies on regulatory matters related to digital and telehealth, data privacy and security, and fraud, waste and abuse compliance.

Arielle routinely counsels clients on the Anti-Kickback Statute, Federal Stark Law, Healthcare Fraud Statute, and applicable state analogues, including issues related to professional fee splitting. In this capacity, Arielle has also prepared and submitted requests for OIG Advisory Opinions related to novel healthcare arrangements.

Arielle provides guidance to various stakeholders in telehealth and digital health models, including practitioners, ancillary providers, private equity investors, marketers, and management and technology companies, through all stages of development. In addition to fraud, waste and abuse matters, common topics at issue include the corporate practice of licensed professions, management services organization creation and implementation, virtual modality requirements for creating bona fide provider-patient relationships, prescribing limitations, reimbursement of remote care, and due diligence of existing telehealth models.

She also counsels health care, life sciences, and technology clients on a broad range of privacy and data security issues, including HIPAA Privacy Rule and Security Standards & HITECH, FTC data privacy for personal health records not protected by HIPAA, and state privacy protections for medical records and sensitive health information. Arielle regularly assists clients with data security incident response and mitigation, federal and state breach reporting, information blocking, and the permissible access, use, de-identification and commercialization of data.  Arielle counsels pharmacy clients on remote prescription processing and central fill arrangements, hub model compliance, compounding pursuant to 503A/503B, delegation of professional and administrative services, prior authorization processing, manufacturer sponsored copayment assistance and cash direct programs, manufacturer rebate compliance, wholesaler and distributor relationships, pharmacy acquisition and sale, and other pharmacy practice considerations. Arielle also assists pharmacy clients with licensing board matters, including audits and preliminary investigations, disciplinary proceedings, and notifications related to changes in pharmacy ownership, oversight, location, and control.

Additionally, Arielle advises practitioners on in-office dispensing, scope of practice, collaboration and supervision of midlevels, and clinical integration.

Arielle works closely with her clients on corporate transactional matters including drafting HIPAA compliance manuals, web terms of use and privacy policies, and agreements for management services, data services, professional services, software development, licensing, marketing, non-disclosure, clinical research organization principal investigators, employment, and asset and stock purchase.

Education

  • Seton Hall University School of Law, Juris Doctor, Health Law Concentration
  • Seton Hall University School of Law, Certificate in Healthcare Compliance
    Comments Editor – Seton Hall Journal of Sports and Entertainment Law
  • Fordham University, Bachelor of Arts 
    Member, Phi Sigma Tau, International Honor Society in Philosophy

Admissions

  • State of New Jersey
  • State of New York

Achievements

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