Baker Donelson's health law attorneys are experienced in all matters involving the Health Center Program, including HRSA Operational Site Visits and other governmental agency audits, regulatory compliance matters, billing and reimbursement issues, the 340B Drug Program, and Federal Tort Claims Act (FTCA) coverage.
Our attorneys also advise health centers on key transactional matters. We have advised FQHCs on collaboration opportunities with health systems and other health centers; establishing residency program collaboration; community affiliations; and expanding clinical capacity, including onsite urgent care centers.
Establishment of an FQHC and FQHC Look-Alike
- Assisting health centers development of new FQHCs, including Look-Alike entities
- Advising on compliance issues, including HRSA requirements for governance and board structure
- Assisting with preparation of necessary FQHC formation documents and HRSA applications
- Advising on and negotiating subgrantee agreements
- Developing hospital system/FQHC partnerships
- Developing integrated primary care/behavioral health programs
Governance/Corporate Structure
- Updating and revising bylaws, including board composition and board responsibilities
- Preparing and/or reviewing required policies and procedures
- Advising on board actions
- Attending board meetings and preparing board resolutions
- Advising subgrantees on requirements relating to relationships with sponsoring FQHCs
- Providing training and educational updates to board members
Compliance with FQHC Requirements/Operational Assistance
- Advising on HRSA Site Visit Protocols and health center program regulations
- Participating in strategic planning sessions with executive staff and board
- Advising on opportunities for federal/state grants and/or other sources of revenue
- Assisting in communications with HRSA
HRSA Site Visits
- Conducting pre-HRSA visit surveys and assisting with preparation for on-site visits
- Assisting with corrective actions from and responses to HRSA audits and site visits
340B Program and Pharmacy Operations
- Advising on contract pharmacy agreements and third-party administrator (TPA) agreements
- Developing 340B Compliance Program and internal audits
- Assisting with in-house pharmacy matters
Federal Tort Claims Act (FTCA)
- Advising on program coverage
- Reviewing claims
- Providing training and compliance for health center staff
- Providing litigation support
HIPAA/HITECH Compliance
- Conducting HIPAA Security Rule risk assessments
- Providing HIPAA security and privacy training
- Reviewing cybersecurity and ransomware issues
Contracts and Service Agreements
- Structuring arrangements with health care providers, business associates, and vendors
- Preparing and/or reviewing all types of contracts and services agreements, including, but not limited to:
- Employment agreements
- Professional services agreements, including coverage agreements
- Administrative services agreements
- Collaboration agreements
- Leases
- Business associate agreements
- Consulting agreements
- License agreements
- Grant agreements
- Loan agreements
- Referral arrangements