Profile
Charles Dunham is a corporate healthcare attorney providing counsel in business, regulatory, compliance, reimbursement, and white-collar defense matters. He represents an array of healthcare providers, suppliers, and other health-related entities with a distinct focus on the laboratory and telehealth industries. He advises private equity firms and venture capital groups on their investments in the healthcare industry, including due diligence reviews of target acquisitions, negotiated contracts, and ongoing regulatory compliance advice related to such investments.
Charles represents a variety of healthcare providers and suppliers:
- Clinical laboratories and pathology group practices
- Telehealth providers and management companies
- Digital health technology companies
- Biotechnology and medical device companies
- Hospitals and health systems
- Physician group practices and networks
- Ambulatory surgery and infusion centers
- Post-acute and long-term care providers
Fraud and Abuse. Charles has a depth of experience in fraud and abuse counseling and white-collar defense matters, involving the federal Anti-Kickback Statute (AKS), Physician Self-Referral Law (Stark Law), False Claims Act (FCA), Eliminating Kickbacks in Recovery Act (EKRA) and analogous state fraud and abuse laws. He utilizes this knowledge to advise clients on structuring compliant ownership, financial, and referral arrangements that are consistent with their business goals. He also represents individuals and entities in federal and state government audits, investigations, and enforcement (civil and criminal).
Mergers & Acquisitions; Commercial Arrangements. Charles represents emerging and established companies on corporate and securities matters, including mergers and acquisitions, public and private securities offerings, equity arrangements, and general corporate formation and operational matters. He also negotiates and drafts professional and executive employment agreements, sales and marketing agreements, and vendor and supplier agreements.
Health Regulatory; Corporate Compliance. Charles assists in developing and implementing compliance programs and training seminars to educate directors, officers, employees, and agents. This includes counseling on federal and state health regulatory compliance, conducting internal compliance reviews and risk audits, designing corrective action strategies, drafting compliance manuals with policies and procedures, and conducting training and education sessions.
Government Licensure and Surveys. Charles advises healthcare providers and suppliers on federal and state licensure and registration requirements to operate and deliver services. He also advises clients responding to surveys and inspections by a government agency or accreditation organization, resolving compliance issues and potential sanctions with government regulators, and challenging enforcement actions in administrative hearings.
Credentialing; Reimbursement; Audits. Charles advises on credentialing and enrollment, network participation and managed care contracting, coverage and reimbursement policies, billing and coding rules, medical necessity and overpayments determinations, and collection of patient responsibility issues. He also represents healthcare providers and suppliers in commercial payor audits and special investigations, payment withholds and unilateral recoupment, and civil litigation matters.
Capabilities
Experience
- Outside general counsel to numerous clinical, pathology, genetic, and other specialty laboratories.
- Advised on CLIA and state laboratory licensure and standards, regulatory compliance and enforcement matters, lab-to-lab referrals and reference lab arrangements, and government and commercial payor reimbursement policies.
- Represented multiple hospitals in the sale of all or segments of their outreach laboratory programs and joint venture arrangements with independent laboratories.
- Represented numerous laboratory owners and directors in responding to and appealing CMS imposed sanctions to suspend or revoke CLIA certification and cancel Medicare payments.
- Advised on FDA oversight of laboratory developed tests (LDTs) and specimen collection kits.
- Counseled on CMS Medicare Part B collection and reporting requirements under PAMA Section 216.
- Counseled on compliance with the federal AKS and EKRA laws and structuring compensation and billing arrangements with sales personnel.
- Counseled hospital and pathology laboratories in the transfer or sale of clinical data and excess diagnostic specimens for research and product development.
- Counseled biobank and cord blood banking organizations on federal and state health regulatory compliance and business initiatives.°
- Outside general counsel to numerous national and regional telemedicine practice groups and management companies offering telemedicine, digital health, remote patient monitoring, and/or virtual care services.
- Advised on state licensure and standard of practice rules, corporate practice of medicine (CPOM) and nursing (CPON) rules, remote prescribing laws, and HIPAA and state privacy and security laws.
- Counseled multiple physician practices on corporate formation, foreign registration, and regulatory compliance with state laws to offer a blend of telemedicine and concierge services by physicians and advanced practitioners in all 50 U.S. states.
- Drafted terms of service, website privacy statements, notice of privacy practices, informed consent and patient authorization forms, disclaimers, and end-user licenses for numerous web-based platforms and apps offering virtual care services.
- Negotiated and drafted numerous professional services agreements related to virtual care and multi-specialty telemedicine services.
- Designed numerous delivery models chronic care management (CCM), remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), and principal care management (PCM) services in compliance with regulatory and reimbursement requirements under Medicare, Medicaid, and commercial health plans.
- Advised numerous web-based companies that utilize telemedicine and digital health technology to deliver consumer-initiated access to remote consultations and laboratory testing or prescription medication services to structure strategic contractual partnerships and workflow that are compliant with federal and state rules and regulations.
- Advised private equity firms on investments in professional practices (ophthalmology, pain management, dermatology, and dental) and formation of management services organizations and operations in compliance with federal and state laws, including corporate practice of medicine, fee-splitting and professional conduct rules, and fraud and abuse laws.
- Represented numerous clients in government and commercial payor claim audits and overpayment demand disputes based on allegations of lack of medical necessity, billing errors, and fraudulent activities.
- Represented a variety 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.
- Counseled 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.°
- Advised an accountable care organization on corporate governance issues, provider participation arrangements, and the implementation of an integrated CMS compliance plan.°
- Represented numerous clients (e.g., hospitals, nursing homes, laboratories) in appealing immediate jeopardy citations through administrative challenges before Administrative Law Judges (ALJs) and the Departmental Appeals Board (DAB).
°The above representations were handled by Mr. Dunham prior to his joining Greenberg Traurig, LLP.
Recognition & Leadership
- Listed, Chambers USA Guide, Healthcare, 2022-2024
- "Up and Coming," 2022-2023
- Super Lawyers Magazine
- Selected, Super Lawyers Houston Rising Stars, 2021
- Selected, Super Lawyers New York Metro Rising Stars, 2016-2022
- Selected, Super Lawyers Upstate New York Rising Stars, 2015
- Member, Center for Telehealth Education and Learning (CTeL)
- CTeL Legal Resource Team Member, 2021-Present
- Advisory Board Member, WBAF USA, 2020-Present
- Member, Clinical Laboratory Management Association (CLMA)
- Member, Legislative, Compliance and Regulatory Committee, 2018-Present
- Member, American Health Lawyers Association
- Member, American Telemedicine Association
- Member, Houston Bar Association
- Member, Health Law Section
- Member, American Bar Association
- Member, Health Section
- Member, New York State Bar Association
- Member, Health Law Section
- Co-Chair, E-Health & Information System Committee, 2014-2017
Credentials
-
J.D., cum laude, Albany Law School
- Health Law Concentration
- Senior Editor, Albany Law Review
- B.A., magna cum laude, State University of New York at Albany
- New York
- Texas
- U.S. District Court for the Northern District of New York
- U.S. District Court for the Southern District of New York
- U.S. District Court for the Western District of New York
- U.S. District Court for the Southern District of Texas
- U.S. Court of Appeals for the Fifth Circuit