Stephanie P. Hales

STEPHANIE HALES 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.

Representative matters have included:

• Advocacy with Congress and federal agencies in connection with Medicare, Medicaid, 340B Program, and Affordable Care Act issues and developments, including high-priority legislative proposals and regulatory actions.
• Representation in connection with a broad range of Medicare national and local coverage determination policies, including analyzing and preparing comments to proposed national coverage policies and draft local coverage determinations, as well as developing and advancing reconsideration requests and challenges to existing policies at the agency level and through administrative litigation.
• Assistance with 340B Program compliance matters, policies and procedures reviews and audits. 
• Successful applications and related advocacy to secure New Technology Add-on Payments (NTAP) for innovative new products under the Medicare Hospital Inpatient Prospective Payment System. 
• Successful applications and related advocacy to establish new and/or revised coding under the Healthcare Common Procedure Coding System (HCPCS), the Current Procedural Terminology (CPT) code set, and the ICD-10 code sets.
• Developing, drafting, and filing regulatory comments; preparing and delivering presentations to federal agencies; and collaborating with other stakeholders regarding proposals and policies affecting coverage, coding, reimbursement, and compliance issues under various federal and state healthcare laws, programs, and regulations.
• Analysis and advice in connection with new product launches and pipeline product development, including risks and opportunities for coverage, coding, and payment; pricing and price reporting considerations; and other issues affecting market access and regulatory requirements for new drugs, biologicals, devices, durable medical equipment, clinical laboratory and diagnostic tests, and other healthcare items and services.

Before joining the firm, Stephanie served as a law clerk to the Honorable Diane P. Wood of the U.S. Court of Appeals for the Seventh Circuit (2007–2008 term). She graduated cum laude from the University of Pennsylvania Law School in 2007. During law school, she was an executive editor of the University of Pennsylvania Law Review and an advocate, shift supervisor, and board member for the Custody & Support Assistance Clinic at Philadelphia Legal Assistance, a family law clinic where a number of cases involved providing support and services to individuals and families experiencing domestic violence and abuse.

While completing her law degree, Stephanie also earned a Master of Biomedical Ethics (M.B.E.) from the Department of Medical Ethics and Health Policy (formerly the Center for Bioethics) based in the in Perelman School of Medicine at the University of Pennsylvania.

• Stephanie serves on the Board of Directors for Whitman-Walker Health clinic and is Secretary of the Board and Chair of the Audit & Compliance Committee. Stephanie also serves on the Board of Directors for Pathways to Housing DC and is Chair of its Governance Committee. She serves as Chair of the Advisory Board for DC’s Children’s Law Center (CLC) and as a member of CLC’s Board of Directors. Additionally, Stephanie serves on the Board of Directors for Network for Victim Recovery of DC (NVRDC) and is an adviser to the Board for the Autoimmune Association.
• Stephanie is a member of Sidley’s Pro Bono and Public Interest Law Committee and is a member and former co-chair of the Washington, DC chapter of SidleyWomen. She is also a former firmwide co-chair of Sidley’s Committee on Summer Associate Programs and a former co-chair of the Washington, DC chapter of Sidley’s Committee on Summer Associate Programs.
• Stephanie is a member of the ABA’s Health Law Section and Administrative Law and Regulatory Practice Section.

Representative pro bono matters have included:

• Representation and negotiation of a favorable settlement for an individual challenging denial of coverage for a specific benefit under the client’s Medicaid insurance.
• Working with Disability Rights Maryland (DRM), successful advocacy for a statewide regulatory change resulting in codification of Maryland Medicaid coverage of hearing aids, cochlear implants, and related services for adults. In 2019, Stephanie received DRM’s Breaking Barriers Legal Advocacy Award on behalf of the Sidley team that worked in collaboration with DRM on this matter.
• Public policy advice, strategic counseling, legislative and regulatory analysis, and advocacy work for leading national nonprofit patient advocacy organizations and coalitions representing patients with rare, serious, and/or chronic conditions.
• Co-authorship of five briefs filed in the U.S. Supreme Court, addressing various criminal justice and civil rights issues — such as, for example, in United States v. Windsor, representing as amici two former Secretaries of Defense, many other retired military leaders, former U.S. Senators and Representatives, and veterans’ organizations who filed a brief in support of Ms. Windsor’s successful constitutional challenge to Section 3 of the Defense of Marriage Act.
• Assistance to a nonprofit healthcare clinic with review, analysis, revision, and further development of compliance policies, procedures, training presentations, and related materials.
• Ongoing representation of a client on death row in Alabama to challenge his death sentence, as part of Sidley’s Capital Litigation Project.
• Successful representation of an individual with HIV and diabetes who appealed denial of SSI/SSD benefits, including an award of back benefits as well as well as benefits going forward.

In 2020, Stephanie received the District of Columbia Bar Association’s Laura N. Rinaldi Pro Bono Lawyer of the Year award, which the D.C. Bar presents to a lawyer for excellence, achievement, and commitment to providing legal services to D.C.’s low income and/or disadvantaged individuals and/or organizations serving such individuals.