Biography

CHARLES C. DUNHAM, IV, is a Member of the Firm in the Health Care and Life Sciences practice at Epstein Becker Green, based in the firm’s New York and Houston offices. He provides counsel and representation to health care providers and health-related entities in a range of matters involving corporate formation and governance, business transactions and acquisitions, commercial arrangements, and health regulatory compliance. His national health law practice focuses on clinical and pathology laboratories, hospitals and health systems, physician group practices and networks, telehealth practitioners and providers, ambulatory surgery and infusion centers, and health information technology companies. He also advises private-equity firms and venture capitalists on health regulatory due diligence reviews and negotiated transaction documents in connection with acquisition and investiture in health care and health-related organizations.

Mr. Dunham is the co-author of Navigating the Telehealth Landscape: Legal & Regulatory Issues, the Telehealth Portfolio Series published annually by Bloomberg BNA, which is the go-to legal resource for telehealth business and regulatory guidance. He is the editor of Epstein Becker Green's TechHealth Perspectives blog, which covers and analyzes telehealth and telemedicine issues as well as privacy and security, health information technology, and state and federal regulatory matters. He also contributes to the firm's Health Law Advisor blog and Client Alerts on a regular basis.

Mr. Dunham’s range of experience includes the following:

  • Fraud and Abuse Counseling and Defense—providing legal analysis and written legal opinions on matters involving the federal Anti-Kickback Statute, Physician Self-Referral Laws (Stark Laws), and the False Claims Act and the equivalent state fraud and abuse laws and regulations
  • Business Transactions and Contracts—conducting due diligence and regulatory compliance reviews of target acquisitions; negotiating and drafting agreements for various transactions, including mergers, acquisitions, and joint ventures; and serving as post-closing counsel related to contractual and regulatory obligations
  • Commercial Arrangements—advising on legal risks and achieving regulatory compliance consistent with business goals, and negotiating and drafting agreements related to various commercial arrangements, including professional and management services, employee and independent contractor relations, equipment and space leases, marketing and sales, and software licensing and service arrangements
  • Payor Reimbursement; Billing and Collections—advising on Medicare and Medicaid enrollment, private network and managed care contracting, and out-of-network provider billing; counseling on reimbursement and overpayments, voluntary refunds, and self-disclosure protocols
  • Government Investigations and Payor Audits—providing representation in government investigations and whistleblower (qui tam) actions; government and accreditation organization surveys and sanctions; government audits (RAC, ZPIC, MAC and Medicaid) and overpayments, including issues based on medical necessity determinations and other payment requirements; and commercial payor (SIUs) audits and unilateral recoupment actions, including issues raised by out-of-network status, such as waiver of patient cost-sharing obligations
  • Patient Privacy and Cyber-Security—advising on HIPAA privacy and security standards and state privacy laws, conducting risk assessments and gap analyses, developing compliance policy and employee training programs, providing representation in complaint investigations and government audits, and counseling in privacy breach and remediation
  • Compliance Programs—counseling on federal and state health regulatory compliance, conducting internal compliance reviews and risk audits, developing and implementing corrective action strategies, developing compliance manual and control protocols, and performing training and education programs

Representative Experience

Clinical Laboratory Industry

  • Serves as outside general counsel to clinical, pathology, genetic, and other specialty laboratories regarding CLIA and state laboratory rules and enforcement, regulatory compliance matters, lab-to-lab referrals and reference lab arrangements, and government and commercial payor reimbursement policies
  • Represented multiple hospitals throughout the country in the sale of all or segments of their outreach laboratory programs and joint venture arrangements with independent laboratories
  • Represented multiple laboratories in successfully defending against CMS-imposed principal sanctions to suspend CLIA certificate and cancel Medicare payments
  • Counseled numerous laboratories on compliance with Medicare regulatory and compliance issues, including CMS Medicare Part B collection and reporting requirements under PAMA Section 216
  • Counseled biobank and cord blood banking organizations on federal and state health regulatory compliance and business initiatives

Telehealth/Telemedicine Industry

  • Serves as outside general counsel to telehealth practice groups and management companies on federal and state regulatory matters related to state licensure and standard of practice, corporate practice of medicine (CPOM) laws, remote prescribing rules, government and commercial payor reimbursement, and HIPAA and state privacy and security laws
  • Counseled a physician practice offering a blend of telemedicine and concierge services in multiple states, on corporate formation and regulatory compliance with federal and state laws

Other Health Care Matters

  • Represented numerous types of health care providers and suppliers in appealing Medicare and Medicaid exclusion, revocation, and deactivation of billing privileges and implementing changes to corporate and regulatory compliance protocol
  • Represented a physician group practice in a joint venture with an integrated health system under a mission support arrangement for hospitalist and outpatient specialty physician services
  • Represented an accountable care organization on corporate governance issues, provider participation arrangements, and the implementation of an integrated CMS compliance plan

Mr. Dunham was named to the Upstate New York Rising Stars list (2015) and New York Metro Rising Stars list (2016 and 2018) in the areas of Health Care and Business/Corporate. He takes a professional interest in understanding a client’s business and operations in order to meet the particular needs of that client. Mr. Dunham is adept at client management and endeavors to set realistic cost estimates and time frames for clients to receive a quality work product.

Education
  • Albany Law School (J.D., cum laude, 2008)
    • Health Law Concentration
    • Albany Law Review, Senior Editor
  • State University of New York at Albany (B.A., magna cum laude, 2004)
Bar Admissions
  • New York
  • Texas
Court Admissions
  • U.S. District Court, Northern District of New York
  • U.S. District Court, Southern District of New York
  • U.S. District Court, Southern District of Texas
  • U.S. District Court, Western District of New York
Memberships
  • American Bar Association, Health Section
  • American Health Lawyers Association
  • New York State Bar Association, Health Law Section
  • Houston Bar Association, Health Law Section
  • Clinical Laboratory Management Association (CLMA) (Legislative, Compliance and Regulatory Committee)