SGR’s authoritative knowledge and cross-discipline expertise help clients confidently navigate one of the most highly regulated and complex industries.
As the Health Care and Life Sciences industry becomes exponentially more complex each year, the pervasive risk of regulatory non-compliance and litigation combined with competitive threats and pressure to produce profits put more stress than ever before on administrators and practitioners. Smith Gambrell Russell’s (SGR’s) team of Health Care and Life Sciences attorneys counsel clients on the full spectrum of legal matters with a collaborative and cross-disciplinary approach that delivers comprehensive, creative and compliant advice on any issue.
Our client base includes hospitals, academic medical centers, long-term care facilities, assisted living facilities, skilled nursing facilities, pharmacies (including participants in the 340B program), laboratories, medical diagnostic technologies, physicians and physician groups, dentists and dental groups, therapists, clinical research companies, management companies, emerging and established biotechnology companies, pharmaceutical and drug delivery companies, nationally acclaimed research centers and universities, medical device companies, and investment, private equity, and venture capital firms targeting life science companies.
Areas of Expertise:
- Regulatory & Compliance
- Health Care Facility Governance and Medical Staff (Medical Staff Credentialing, Peer Review, Disputes, Bylaws, and Policies; Facility Governance Matters)
- Life Sciences/Biotechnology
- Drugs and Devices
- Intellectual Property
- Technology and Cybersecurity
- Health Care Real Estate and Construction
- Health Care Mergers, Acquisitions, and Other Transactions
- Employee Benefits and Executive Compensation
- Health Care Litigation
- International Clients
- Manufacturing and Supply Chain for Critical Medical Supplies
- Catholic Archdiocese of Atlanta
- Emory Healthcare
- HCA Healthcare
- Piedmont Healthcare
- Wesley Woods Senior Living
- Hemophilia of Georgia
- Montecito Medical Real Estate
- Augusta University Research Institute
- American Thrombosis and Hemostasis Network
- Summit Spine & Joint Centers
- McIntosh Clinic
- Nephrology Consultants of Georgia
- Tift County Hospital Authority
- Private Hospital Authority of DeKalb County
Regulatory & Compliance
Our team regularly advises facilities, individual and groups of practitioners, and other health care, biotech, and life sciences companies on all of their legal needs, including specialized assistance with issues related to:
- Facility permits and licensing
- Medicare/Medicaid provider enrollment
- Medicare/Medicaid audits and hearings
- HIPAA Privacy
- HIPAA Security
- The ACA & HITECH Act
- Anti-Kickback Statute
- Stark Law
- Government investigations
- Medical Staff Bylaws & Policies
- Joint ventures
- National Practitioner Data Bank
- Operational policies
- compliance with Conditions of Participation
- Self-disclosure protocols
- Credentialing and peer review
- Compliance plans and programs
- Medical & professional liability
- Certificate of Need; Determinations and Letters of Nonreviewability
- State licensure boards
- Risk management
- CDC recommendations
- Managed care matters
- FDA matters
- FQHCs, Rural Health Clinics
- 501(c)(3) requirements
- 340B Pharmacy requirements
- Clinical research agreements and IRB compliance
- HHS Provider Relief Fund Compliance
- Independent Contractor, Medical Director, Hospital-Based Physician, Physician Recruitment, and other operational agreements
- The Ethical and Religious Directives for Catholic Health Care Services
- CARES Act
SGR’s Health Care & Life Sciences Practice Group attorneys counsel clients on the wide variety of industry-specific regulatory and compliance matters such as those described above, whether they arise in connection with major projects or as a matter of day-to-day operations. We assist individual practitioners and entities with regulatory and licensing board hearings, investigations, disciplinary matters, licensing issues, litigation, strategizing on the most effective and expeditious path to required FDA approvals, and implementing clinical trials and protocols. Our team members have experience working as hospital general counsel and as government attorneys. The Firm also represents the Catholic Archdiocese of Atlanta, and our attorneys are well-versed in the Ethical and Religious Directives for Catholic Health Care Services. SGR’s regulatory and compliance experts also regularly work closely with colleagues specializing in other legal disciplines needed by Health Care and Life Sciences industry clients such as corporate, M&A, capital structures, litigation, employment, and international matters to find the best compliant solutions meeting the specific needs of each client’s business.
Health Care Facility Governance and Medical Staff (Medical Staff Credentialing, Peer Review, Disputes, Bylaws, and Policies; Facility Governance Matters)
These SGR attorneys have extensive experience assisting both Medical Staff organizations and individual practitioners with matters relating to the facility/Medical Staff credentialing, peer review, physician discipline and hearings, and development of facility and Medical Staff Bylaws and Policies (including representing medical professional societies in creating model Bylaws and Policies). For Medical Staff disciplinary hearings, we have experience as hearing officers, counsel for the Medical Staff, and counsel for the practitioner. Our attorneys have served on hospital boards, as in-house counsel, and in other governance roles, which provide them with unique insight on how best to assist clients with these matters.
Drugs and Devices
SGR attorneys work closely with clients to assist them with meeting FDA and other requirements applicable to manufacturing, importing, and distributing drugs and medical devices, including (during the COVID-19 pandemic period) assistance with frequently-changing requirements applicable to FDA Emergency Use Authorizations. We also structure agreements with principal investigators and sites and assist with IRB reviews as necessary, as well as assisting with corporate structuring, financing, and other related matters.
Our team includes attorneys who use their expertise in intellectual property to help pharmaceutical and biotechnology clients transform scientific research into real-world innovation and commercialization. Our patent attorneys have scientific and technical degrees and training in biology, chemistry, biochemistry, molecular biology, and other related fields. With our extensive research and development experience in the pharmaceutical and biotech industries, we use our legal expertise to help our clients – the scientists, inventors, universities, manufacturers, and innovators – protect the valuable work on new drugs and devices that gives them a competitive edge. Our patent/IP legal services include opinion work (such as patentability, clearance, infringement, and invalidity opinions), patent filings in the U.S. and coordination of filings in foreign patent jurisdictions, reexaminations and reissues, appellate and post-grant procedures, trademark searches, procurement, and oppositions, licensing and technology transfer, litigation and expert witness.
Technology and Cybersecurity
The Firm’s Technology Practice Group assists providers of technology products and services with a wide array of transactional matters and legal issues. For Health Care and Life Sciences industry clients, these include clinical study and clinical trial agreements, development and collaboration agreements, and venture capital and private equity financings. The HIPAA expertise of SGR’s Health Care Regulatory team is also complemented by the Technology Practice Group’s Cybersecurity expertise, through which Health Care and Life Sciences industry clients can obtain assistance with the security and privacy requirements of HIPAA as well as the applicable requirements of other applicable state, federal, and international laws.
Health Care Real Estate and Construction
We advise health care and life science clients on the full spectrum of their real estate legal needs, including those related to medical office buildings, urgent care clinics, nursing homes, assisted living facilities, hospitals, physician offices, laboratories, and other health care industry clients. We negotiate, perform due diligence and prepare contracts for purchasing property, development, construction, leasing, and a variety of other real estate matters that may arise, such as early termination of leases or amending the terms of leases. Our leasing experience includes representation of a wide range of clients, from large medical office building landlords to individual lessees. We also have extensive experience advising on the significant regulatory, safety, and building code requirements that apply to the construction of buildings in which health care services will be provided or drugs/devices will be manufactured. Our construction experience covers all aspects of building new or renovating existing health care and life sciences facilities, including contracting for design and construction, code compliance assistance, and construction dispute avoidance and resolution.
Employee Benefits & Executive Compensation
SGR’s Employee Benefits & Executive Compensation Group is well-versed in the employee benefit plan design and compliance considerations uniquely applicable to the Health Care and Life Sciences industry. SGR’s attorneys have significant experience designing benefit plans for both traditional and flexible workforces in compliance with ERISA, the Internal Revenue Code, and other federal regulations; tackling the additional HIPAA privacy and security obligations applicable to group health benefits offered to employees; and assisting with the establishment of onsite clinics, disease management programs, and wellness initiatives. As a complement to SGR’s Health Care Regulatory Practice, SGR’s attorneys also regularly advise health care industry clients on the employer and health plan implications of the Affordable Care Act, including the Act’s employer mandate, reporting, and plan design requirements.
Health Care Mergers, Acquisitions, and Other Transactions
The rapid pace of consolidation among health care providers continues. Our team has extensive experience in helping clients negotiate and structure mergers, acquisitions, divestitures, spin-offs, joint ventures, and integrated delivery systems. We also help clients with forming new entities, capital structuring, public financing such as tax exempt bonds, debt refinancing, restructuring, and bankruptcy protection. On any transaction, we provide support on due diligence, tax, employment, real estate, insurance, securities, and all other related corporate law matters in addition to matters related to health care regulatory compliance.
By combining the wealth of talent and experience of our Health Care and Life Sciences Practice Group with the Firm’s outstanding International Law practice, SGR provides international clients with detailed expertise on the requirements for doing business in the U.S. Health Care and Life Sciences industry. For clients wishing to locate their first or next production facility in the U.S., SGR’s Site Selection group works with strategic partners to help our clients assess potential sites, assists in the negotiation of a targeted incentive package, and facilitates the establishment of relationships with the state and local communities. Health Care and Life Sciences Practice Group attorneys also work closely with the Firm’s international clients to assist them with meeting FDA and other requirements applicable to manufacturing, importing and distributing drugs and medical devices; we work with SGR’s Immigration attorneys in assisting medical professionals and executives with specialized visa matters, and we provide health care regulatory compliance advise as part of the Firm’s team approach to providing coordinated advice to international clients. SGR is also helping clients navigate the evolving incentives and requirements relating to domesticating the manufacturing of medical supplies and equipment.
Health Care Litigation
When litigation inevitably occurs, SGR’s national team of litigation attorneys work aggressively on effective and efficient strategies to achieve favorable outcomes. We collaborate with clients to understand their risk tolerance and business objectives and tailor our approach to meet their needs. We often represent clients in federal and state lawsuits in jurisdictions across the country and appeals, administrative proceedings, and alternative dispute resolution forums such as arbitration and mediation. The range of our litigated matters includes, e.g., the defense of medical and professional liability lawsuits, the defense of individuals and organizations in “white collar” criminal matters, and representing our clients’ positions before administrative law judges in hearing and appeals of Certificate of Need-related matters, Medicare, and Medicaid.
Manufacturing and Supply Chain for Critical Medical Supplies
In response to increasing government initiatives intended both to expand domestic production of critical medical supplies and equipment and to prohibit the use of such equipment and materials from countries determined to be hostile to U.S. interests, SGR has created an Onshoring Initiative. Through the Onshoring Initiative, a wide spectrum of SGR attorneys assist both U.S. and international clients in taking advantage of increasing government incentives to open or expand domestic production of critical medical supplies and equipment.