Skip to main content
Charles C. Dunham, IV

Charles Dunham is a business and health care attorney providing counsel in regulatory, corporate, transactional, reimbursement, compliance, 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 clinical laboratory and telehealth industries. He also advises private equity firms and venture capital groups on their investments in the health care industry involving regulatory due diligence reviews of target acquisitions, negotiated transaction documents, and general oversight of such investments with health regulatory compliance.

Charles represents a variety of clients:

  • 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 (criminal and civil).

Transactional; Mergers & Acquisitions. 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 matters He also works with management to negotiate and draft professional and executive employment agreements, sales and marketing services agreements, and vendor and supplier agreement.

Health Regulatory; Corporate Compliance. Charles works with a range of health care providers and suppliers to develop and implement 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, developing and implementing corrective action strategies, drafting a compliance manual with policies and procedures, and conducting training and education sessions. He also advises clients on responding to accreditation organization surveys and government inspections, resolving compliance issues and potential sanctions with 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 investigations (SIUs), payment withholds and unilateral recoupment, and civil litigation matters.

Capabilities

Experience

  • Outside general counsel to multiple clinical, pathology, genetic, and other specialty laboratories advising 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 throughout the country 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 CLIA certificate and cancel Medicare payments.
  • Advised clinical laboratories and private investors 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 Anti-Kickback Statute and Eliminating Kickbacks in Recovery Act (EKRA) and structuring compensation and billing arrangements with sales personnel
  • Counseled biobank and cord blood banking organizations on federal and state health regulatory compliance and business initiatives.°
  • Counseled hospital and pathology laboratories in the transfer or sale of excess diagnostic specimens for research and product development.
  • 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 cross-border formation and operations involving regulatory matters related to state licensure and standard of practice rules, corporate practice of medicine (CPOM), remote prescribing laws, government and commercial payor reimbursement, and HIPAA and state privacy and security laws.
  • Counseled multiple physician practices offering a blend of telemedicine and concierge services in multiple states on corporate formation, foreign registration, and regulatory compliance with federal and state laws.
  • Negotiated and drafted numerous telemedicine professional services agreements between hospitals and a telemedicine companies for virtual care and multi-specialty medical services via telemedicine services.
  • Counseled a private-equity firm on legal and regulatory requirements under federal and state law for healthcare providers to deliver and bill for remote patient monitoring (RPM) services and outline the coverage and reimbursement landscape under Medicare, Medicaid, and commercial health plans.
  • Advised numerous web-based companies that utilize telemedicine and remote patient monitoring to deliver consumer-initiated access to health consultations and testing services which require strategic partnerships and service delivery workflow and revenue stream compliant with federal and state rule 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.°

°The above representations were handled by Mr. Dunham prior to his joining Greenberg Traurig, LLP.

Recognition & Leadership

  • Super Lawyers Magazine
    • Selected, Super Lawyers New York Metro Rising Stars, 2016-2018
    • Selected, Super Lawyers Upstate New York Rising Stars, 2015
  • 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

Education
  • 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
Admissions
  • 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