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 health care 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 health regulatory compliance by such investments post-closing.
Charles represents a variety of health care providers and suppliers:
- Clinical laboratories and pathology groups
- Telehealth providers and management 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; Transactional. 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 works with management to negotiate and draft professional and executive employment agreements, sales and marketing services agreements, and vendor and supplier agreements.
Health Regulatory; Corporate Compliance. Charles assists in developing and implementing strong 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 health care 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, billing and coding rules, medical necessity and overpayments determinations, and collection of patient responsibility issues. He also represents health care 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 rules and enforcement, regulatory compliance 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 defending against CMS imposed principal sanctions to suspend or revoke CLIA certification and cancel Medicare payments.
- Advised on FDA and CLIA requirements and oversight of laboratory developed tests (LDTs).
- Counseled on compliance with Medicare regulatory and compliance issues, including 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 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 federal and state laws to offer a blend of telemedicine and concierge services in all 50 U.S. states.
- Negotiated and drafted numerous professional services agreements for virtual care and multi-specialty telemedicine services.
- Designed numerous platforms for delivering remote patient monitoring (RPM) services in compliance with regulatory and reimbursement requirements under Medicare, Medicaid, and commercial health plans.
- Advised numerous web-based companies that utilize telemedicine and RPM to deliver consumer-initiated access to telemedicine consultations and laboratory testing services which require strategic 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, professional conduct rules, and fraud and abuse laws.
- Advised large and small medical device companies (including many in vitro diagnostic companies), clinical laboratories, and trade associations in the life sciences industry with compliance with the Food, Drug, and Cosmetic Act and FDA Guidance documents.
- 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 a variety of health care providers and suppliers (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) of the U.S. Department of Health and Human Services.
°The above representations were handled by Mr. Dunham prior to his joining Greenberg Traurig, LLP.
Recognition & Leadership
- Listed, Chambers USA Guide, Healthcare, "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), 2021-Present
- CTeL Legal Resource Team Member
- Advisory Board Member, WBAF USA, 2020-Present
- Member, Clinical Laboratory Management Association (CLMA), 2018-Present
- Member, Legislative, Compliance and Regulatory Committee, 2018-Present
- Member, American Health Lawyers Association, 2016-Present
- Member, Houston Bar Association, 2016-Present
- Member, Health Law Section, 2016-Present
- Member, American Bar Association, 2015-Present
- Member, Health Section
- Member, New York State Bar Association, 2009-Present
- Member, Health Law Section, 2010-Present
- 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