Profil
Nicole Galli Baptista is a member of the Health Care & FDA Practice in Greenberg Traurig’s Washington, D.C. office. Nicole regularly assists physician groups, home health agencies, residential care facilities, med spas, and laboratories with issues related to licensing, billing/coding, reimbursement, telehealth, and the corporate practice of medicine. Nicole also assists manufacturers and distributors of pharmaceutical, medical device, food/beverage, dietary supplement, and cosmetic products on complying with FDA and FTC regulations. Nicole’s services include, but are not limited to: providing regulatory counseling, conducting compliance audits, drafting contracts and policies, submitting licensing applications, and conducting due diligence for mergers and acquisitions.
Kompetencje
Doświadczenie
- Conducted external audits evaluating compliance with the Anti-Kickback Statute, Stark law, and EKRA.
- Prepared health care regulatory disclosure schedules for acquisitions of laboratories and home health agencies.
- Submitted state licensing application for a residential care facility following a change in ownership.
- Drafted delegation and collaboration agreements for physician assistants and advanced practice nurses.
- Advised accountable care organizations on permissible incentive payments for Medicare beneficiaries.
- Counseled med spas on risks related to prescribing and administering compounded pharmaceuticals.
- Researched state licensing requirements for wholesale distributors of Rx medical devices and OTC drugs.
- Advised device manufacturers on FDA labeling and packaging requirements for convenience kits and accessories.
- Requested orphan drug exemption from PDUFA program fees for small manufacturer of a rare disease drug.
- Prepared 510(k) submissions for remote monitoring devices and for software as a medical device.
- Advised foreign food producer on facility registration, prior notice of importation, and GRAS requirements.
- Researched co-development and cross-labeling requirements for a drug-biologic combination regimen.
- Health Law Research Assistant, University of Georgia School of Law, 2020-2021
- Client Advocate, Tennessee Justice Center, 2018-2019
- Health Law Extern, American Bar Association, Center on Children and the Law, 2022
- Legal Extern, HHS Office of the General Counsel, Centers for Disease Control and Prevention, 2021
- Legal Intern, Atlanta Legal Aid Society, Health Law Partnership, 2021
- Policy Research Intern, ThinkTennessee, 2017
- Undergraduate Intern, Broward County State’s Attorney Office, 2017
Sukcesy i wyróżnienia
- Recognized, State Bar of Georgia, “Alan Rumph Memorial Health Law Fellowship,” 2021
- Member, District of Columbia Bar Association, 2022-Present
- Member, American Health Law Association, 2020-Present
Kwalifikacje
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J.D., cum laude, University of Georgia School of Law
- President, Health Law Society
- Member, Moot Court Team
- B.A., Vanderbilt University
- District of Columbia
- Portuguese, biegły
- hiszpański, Proficient
- francuski, konwersacyjny