Alexandra B. Maulden

Associate

Alexandra B. Maulden

Associate

Alexandra (Alex) Maulden is an associate with Foley & Lardner LLP and a member of the firm’s Health Care Practice Group in the Boston office.

During law school, Alex was selected for the Mayo-Foley Health Law Fellowship, consisting of summer internships with the Mayo Clinic Legal Department in Rochester, Minnesota and Foley’s Boston office. During this time, she assisted attorneys at both the Mayo Clinic and Foley 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’s Hospital, where she coordinated with medical staff to identify eligible research study patients and discussed study procedures with patients.

 

Presentations and Publications

  • Co-author, “FDA Issues New Warning Regarding Compounded Ketamine,” Health Care Law Today (October 26, 2023)
  • Co-author, “Gender Affirming Care in Florida: Current Rules of the Road,” Health Care Law Today (August 23, 2023)
  • Co-author, “Gender Affirming Care Restricted Under Missouri Bill,” Health Care Law Today (May 16, 2023)
  • Co-author, “Florida’s Bill Targeting Gender Affirming Care Impacts Minors and Adults,” Health Care Law Today (May 9, 2023)
  • Co-author, “FDA Publishes Framework for Digital Health Technologies in Clinical Trials,” Health Care Law Today (April 3, 2023)
  • Author, “Ignoring the Experts: Implications of the FDA’s Aduhelm Approval” 48 American Journal of Law and Medicine 108-133 (July 11, 2022)
  • Co-author, “United States,” The Healthcare Law Review (July 30, 2021)
  • Author, “Wearables and the FDA: Lessons from the COVID-19 Pandemic,” DOME BLOG (June 28, 2021)
  • Co-author, “11th Circuit FCA Ruling Takes Practical Approach to Materiality,” Law360 (July 8, 2020)
  • Co-author, “Diagnostic Performance of C6 Enzyme Immunoassay for Lyme Arthritis,” Pediatrics (January 1, 2020)
  • Co-author, “Positive 2-Tiered Lyme Disease Serology is Uncommon in Asymptomatic Children Living in Endemic Areas of the United States,” Pediatric Infectious Disease Journal (May 2019)
  • Author, “Two-tier Lyme Disease Serology Test Results Vary By First-tier Test,” Pediatric Journal of Infectious Disease Society (February 22, 2019)
  • Co-author, “C-Reactive Protein or Erythrocyte Sedimentation Rate Results Reliably Exclude Invasive Bacterial Infections,” The American Journal of Emergency Medicine (November 8, 2018)
  • Co-author, “Accuracy of Clinician Suspicion of Lyme Disease in the Emergency Department,” Pediatrics (September 21, 2017)
07 February 2024 Health Care Law Today

Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities

On February 1, 2024, the Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs as part of the Biden Administration’s Overdose Prevention Strategy.
02 February 2024 Health Care Law Today

Behavioral Health: CMS Innovation Model Outlines Changes for the Delivery of Integrated Behavioral and Physical Health Care

On January 18, 2024, the Centers for Medicare & Medicaid Services announced a new innovation model designed to improve quality of care and behavioral and physical health outcomes for Medicaid and Medicare patients with moderate to severe mental health conditions and substance use disorders.
10 November 2023 Health Care Law Today

CMS Expands Access to Behavioral Health Services; Physician Fee Schedule Expands Billing Providers and Flexibilities

On November 2, 2023, the Centers for Medicare and Medicaid Services issued its 2024 Physician Fee Schedule final rule (Final Rule) for calendar year 2024 that will, in part, implement some of the most important changes to improve access to behavioral health care in Medicare’s history.
31 October 2023 Health Care Law Today

FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On October 23, the FDA issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on its website.
30 October 2023 Health Care Law Today

FDA’s New Enforcement Policy: A Win for Remote Patient Monitoring and Remote Therapeutic Monitoring Manufacturers

On October 19, 2023, the FDA issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.
26 October 2023 Health Care Law Today

FDA Issues New Warning Regarding Compounded Ketamine

On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products.