Nelson Hardiman provides legal counsel to enable Federally Qualified Health Centers (FQHCs) to fulfill their critically important mission as local community healthcare providers. We guide non-profit community clinics through the complicated regulatory framework to form FQHCs. We have worked closely with these community-based organizations, including both Section 330 grantees and “look-alike” FQHCs, to maintain compliance while collaborating on creative solutions for advancing their mission.

We understand the unique challenges that FQHCs face in meeting the needs of stakeholders while complying with the myriad and nuanced requirements of multiple laws and agency regulations. These include the Health Resources and Services Administration (“HRSA”), the Internal Revenue Service (“IRS”), the California Department of Public Health (“DPH”) and the California Department of Health Care Services (“DCHS”). We go beyond traditional legal advice and engage with regulators, contracted and affiliated providers, strategic partners, and Risk Bearing Organizations (RBOs)/health plans. Nelson Hardiman lawyers cut through the complex legal challenges faced by FQHCs and empower our clients to excel at delivering essential primary and preventive healthcare.

Our Work Includes:

  •  340b and Contract Pharmacy Arrangements Counseled on strategic participation in the federal 340b drug discount program, and advised in the structuring of contract pharmacy arrangements and compliance with HRSA’s rules and guidelines for contract pharmacy agreements, including negotiating agreements with the contract pharmacies to ensure compliance and fair terms.
  • Compliance Advised on compliance with federal and state anti-kickback laws and HRSA requirements, including drafting policies and procedures.
  • Corporate formation Handled various aspects of corporate formation and scope of project for funding, including filings with the State and assistance with HRSA forms.
  • HIPAA Consulted on HIPAA and California privacy and security requirements.
  • HRSA Audit Advised on a HRSA audit that concerned whether the FQHC was meeting the requirements of the Section 340b drug program.
  • Medi-Cal Audit Dispute Successfully filed a petition for writ of mandate to overturn a Medi-Cal audit decision by DHCS about whether a clinic operated by a medical center qualified as a FQHC.
  • Nonprofit status Counseled a non-profit entity and its Board to ensure compliance with IRS rules and avoid private inurement or excess benefit transactions.
  • Practice Acquisitions Represented a clinic in the purchase of medical practices in connection with service site additions under HRSA and DPH. Handled all aspects of the transactions, including the purchase agreements and finance documents, due diligence, lease agreements, employment agreements and independent contractor agreements.