STEPHANIE HALES is a partner in the Healthcare and Government Strategies groups. Stephanie regularly counsels clients on healthcare legislative and regulatory developments and their impact, providing strategic advice, analysis and advocacy targeted to clients’ internal leadership and personnel as well as to courts, Congress, policymakers at federal and state agencies and other stakeholders. She focuses her practice on healthcare regulatory, compliance and legislative matters, including strategic counseling in connection with public policy proposals and implementation issues.
Stephanie has experience in healthcare coverage, coding and reimbursement issues; government price reporting; administrative litigation; managed care and market access matters; healthcare contracting; healthcare compliance; government agency and congressional investigations; and health information privacy and security. She advises clients on a broad range of issues and provisions under Medicare, Medicaid, the 340B Drug Pricing Program and the Affordable Care Act (ACA). She has deep knowledge and experience relating to the legislative and regulatory history of the ACA, ongoing ACA implementation issues and related legal challenges. Areas of experience include the law’s changes to the Medicare, Medicaid and 340B programs; development and implementation of the ACA-created Exchanges and Essential Health Benefits package; enforcement of the ACA’s nondiscrimination provisions; amendments to HIPAA requirements; increased transparency obligations under the Sunshine Act; and other reforms, regulations and litigation affecting government healthcare programs and the commercial insurance market. Stephanie also recently served as adjunct faculty at the University of Pennsylvania for a health policy course titled “The Future of the American Health Care System: Health Policy and the Affordable Care Act,” offered through the Department of Medical Ethics & Health Policy.
Stephanie’s clients have included pharmaceutical, biologics and medical device manufacturers, durable medical equipment suppliers, patient advocate organizations, clinical laboratories, diagnostic test manufacturers, healthcare professional societies and trade associations, health plans and insurers, health IT companies, financial institutions, hospitals and physician practices, among others. She also has represented individuals and organizations on a pro bono basis in matters challenging Medicaid coverage denials, appealing disability benefits denials, advocating on healthcare public policy issues and seeking relief relating to criminal justice issues. In connection with her work on healthcare coverage and access issues, Stephanie was named an “Autoimmune Hero” by the American Autoimmune Related Diseases Association in 2016 and was a recipient of Disability Rights Maryland’s 2019 Legal Advocacy Award. Stephanie is also the recipient of the District of Columbia Bar Association’s Laura N. Rinaldi Pro Bono Lawyer of the Year award for 2020.