Alexandra B. Maulden
Associate
Alexandra (Alex) Maulden is a health care lawyer with 麻豆传媒 and a member of the firm鈥檚 Health Care Practice Group. Alex鈥檚 practice focuses on a broad range of federal and state regulatory compliance and business matters for health industry clients, including hospitals, health systems, provider practice groups, long-term care facilities, clinical laboratories, and telemedicine companies.
Alex has experience providing federal and state regulatory compliance guidance specifically related to fraud and abuse laws including anti-kickback statutes, physician fee-splitting statutes, and physician self-referral laws, as well as state licensure rules, government and commercial reimbursement issues, federal DEA and state-controlled substances laws. Her practice also includes conducting internal investigations, and operational matters like drafting contracts and compliance policies. In particular, Alex counsels clients in the substance use disorder space on licensing, regulatory compliance, general business matters, and the intersection of state and federal law. Drawing on her background in clinical research, Alex has also assisted in the development and maintenance of clinical trial compliance programs, and has drafted and reviewed clinical trial agreements and corporate policies on behalf of institutions, contract research organizations, and pharmaceutical聽clients.
During law school, Alex was selected for the Mayo-麻豆传媒 Health Law Fellowship, consisting of summer internships with the Mayo Clinic Legal Department in Rochester, Minnesota and 麻豆传媒鈥檚 Boston office. During this time, she assisted attorneys at both the Mayo Clinic and 麻豆传媒 with a broad range of regulatory compliance and transactional matters. While in law school, she also interned with the Whistleblower Law Collaborative where she researched a variety of issues relating to health care fraud and abuse, with a specific focus on the Coronavirus Relief Fund.
Before law school, Alex was a clinical research assistant in the Emergency Department at Boston Children鈥檚 Hospital, where she coordinated with medical staff to identify eligible research study patients and discussed study procedures with patients.
Presentations and Publications
- Co-author, 鈥淔DA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials,鈥 Health Care Law Today (Fenruary 3, 2025)
- Co-author, 鈥淒EA Tightens Buprenorphine Telemedicine Prescribing Rules,鈥 Health Care Law Today (January 16, 2025)
- Co-author, 鈥淢edicare Telehealth Flexibilities Get a Three-Month Lifeline,鈥 Health Care Law Today (December 23, 2024), republished in Chicago Medicine鈥檚 February 2025 issue
- Co-author, 鈥淔DA Clinical Investigations: New Guidance on Electronic Systems,鈥 Health Care Law Today (November 20, 2024)
- Co-author, 鈥淪ubstance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage,鈥 Health Care Law Today (July 29, 2024)
- Co-author, 鈥淐linical Trials: FDA Publishes Draft Guidance on Diversity Action Plans,鈥 Health Care Law Today (July 25, 2024)
- Co-author, 鈥淣ew Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers,鈥 Health Care Law Today (April 25, 2024)
- Co-author, 鈥淔DA Issues New Warning Regarding Compounded Ketamine,鈥澛Health Care Law Today聽(October 26, 2023)
- Co-author, 鈥淕ender Affirming Care in Florida: Current Rules of the Road,鈥 Health Care Law Today (August 23, 2023)
- Co-author, 鈥淕ender Affirming Care Restricted Under Missouri Bill,鈥 Health Care Law Today (May 16, 2023)
- Co-author, 鈥淔lorida鈥檚 Bill Targeting Gender Affirming Care Impacts Minors and Adults,鈥澛Health Care Law Today聽(May 9, 2023)
- Co-author, 鈥淔DA Publishes Framework for Digital Health Technologies in Clinical Trials,鈥澛Health Care Law Today聽(April 3, 2023)
- Author, 鈥淚gnoring the Experts: Implications of the FDA鈥檚 Aduhelm Approval鈥 48 American Journal of Law and Medicine 108-133 (July 11, 2022)
- Co-author, 鈥淯nited States,鈥澛The Healthcare Law Review聽(July 30, 2021)
- Author, 鈥淲earables and the FDA: Lessons from the COVID-19 Pandemic,鈥澛燚OME BLOG聽(June 28, 2021)
- Co-author, 鈥11th Circuit FCA Ruling Takes Practical Approach to Materiality,鈥 Law360 (July 8, 2020)
- Co-author, 鈥淒iagnostic Performance of C6 Enzyme Immunoassay for Lyme Arthritis,鈥 Pediatrics (January 1, 2020)
- Co-author, 鈥淧ositive 2-Tiered Lyme Disease Serology is Uncommon in Asymptomatic Children Living in Endemic Areas of the United States,鈥 Pediatric Infectious Disease Journal (May 2019)
- Author, 鈥淭wo-tier Lyme Disease Serology Test Results Vary By First-tier Test,鈥 Pediatric Journal of Infectious Disease Society (February 22, 2019)
- Co-author, 鈥淐-Reactive Protein or Erythrocyte Sedimentation Rate Results Reliably Exclude Invasive Bacterial Infections,鈥 The American Journal of Emergency Medicine (November 8, 2018)
- Co-author, 鈥淎ccuracy of Clinician Suspicion of Lyme Disease in the Emergency Department,鈥 Pediatrics (September 21, 2017)
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鈥淭he Great American Recovery Initiative鈥: What President Trump鈥檚 New Executive Order Means for Behavioral Health Providers
Medicare Advantage: New OIG Compliance Guidance Has Implications for Providers
Gender-Affirming Care: Multi鈥慡tate Lawsuit Challenges HHS Declaration
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Gender-Affirming Care for Minors: CMS and HHS Propose Limits on 鈥淪ex Rejection Procedures鈥 and Expanded Enforcement Pathways
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Health Care Marketing Enforcement: FTC Targets Telehealth Company for Deceptive Weight Loss Marketing Claims
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