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Compliance with 340B

Members of Robinson+Cole’s Health Care group are skilled in advising hospitals and health care systems on maintaining 340B program compliance in the face of evolving guidance and legal developments. Our lawyers view 340B program compliance within the wider context of hospital health care compliance, including pharmacy operations regulations, hospital-based outpatient locations, and fraud and abuse laws.

Our Services

Our team assists hospital and health care system clients with legal matters in the following areas:

  • Tracking 340B legal and policy-related developments, including with respect to:
    • Changes to reimbursement for 340B drugs;
    • Contract pharmacy restrictions;
    • Establishing policies and procedures defining eligible patients and providers;
    • Implications of various federal and state legislative efforts; and
    • Compliance with state Medicaid billing regulations.
  • Advising on 340B program compliance in general;
  • Reviewing and negotiating contract pharmacy agreements, third-party administrator agreements, specialty drug distributor agreements, and 340B consulting agreements;
  • Counseling in relation to drug manufacturer payment inquiries, Health Resources and Services Administration (HRSA) audit preparations, and related reviews of 340B policies and procedures;

Our Team

Attorneys in our Health Law group can provide multidisciplinary support at the intersection of regulatory compliance and transactional law for our 340B-covered entity clients.

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