David E. Schweighoefer

Counsel

David is a highly experienced health care attorney who advises numerous clients regarding regulatory and corporate compliance program development, patient rights, informed consent policies, and procedure development. He has deep knowledge in designing and implementing Stark-compliant physician compensation programs, employment and recruitment contracts, and corporate compliance programs. David advises hospital providers on HCQIA Fair Hearing procedures, compliance audits for HIPAA, and HITECH policies. He creates procedures for hospitals and ambulatory surgery centers, as well as breach notification policies for providers. He also develops compliant health insurance programs and advises clients on matters related to The Affordable Care Act.

David has helped facilities and providers to operate successfully in changing regulatory environments, and achieve and maintain regulatory compliance with the Joint Commission Standards, AOA, CMS, ODMH, and the Ohio Department of Health. He also interprets Medicare Physician Fee Schedule issues and provides RAC audit compliance and overpayment recovery and appeal advice. He has experience in the design, development, and implementation of behavioral medicine services, as well as new construction and renovation of inpatient and outpatient programs. Prior to law school, David worked as a CEO at hospitals in Milwaukee and Northeast Ohio, and also served as the COO of a multi-hospital regional system.

Education & Admissions

Education

  • Michigan State University

    (B.S., 1972)

  • University of Michigan

    (M.A., 1978)

  • Cleveland-Marshall College of Law

    (J.D., 2002; LL.M in process)

Admissions

  • State of Ohio

Experience

  • Experience with a wide variety of health care matters, including RAC and ZPIC appeals, provider M&A transactions, vendor and employment agreements, DME and clinical laboratory compliance plans, security risk analysis and cybersecurity matters, and federal overpayment analysis.
  • Advises clients regarding regulatory compliance pertaining to the Anti-Kickback Statute; the Stark laws and False Claims statutes; medical device manufacturers and medical device re-manufacturers regarding FDA compliance and 501(k) certification; HIPAA and HITECH Privacy and Security Rule compliance and risk analysis; HIPAA breach notification policy and procedure development; Home Health Agency licensing; and EMTALA guidance.
  • Experience with Medicare and Medicaid provider enrollment, billing and Medicare secondary payer compliance, Medicare secondary payer issues and requirements in liability settlements, and appeals of Medicare Part B and D denials.
  • Experience with the design of Stark compliant physician compensation programs; independent practitioner contract review; corporate compliance program development and implementation; physician hospital integration strategies; pharmacy and laboratory compliance guidance; and managed care contracting guidance and contract review.
  • Represents Ohio licensed healthcare providers regarding licensing board investigations and complaints.
  • Experience revising and drafting close corporation documents for physician practices; revising hospital medical staff bylaws; assisting with the sale and acquisition of medical practices; and advising on IDTF lease and equipment agreements, joint venture creation and unwinding of corporate entities, and physician LLC formation.
  • Represents and provides valuable counsel to owners, operators, and managers of skilled nursing and assisted living facilities throughout the United States, and has experience developing review mechanisms for nursing home admissions agreements and related arbitration clauses.
  • Serves as outside general counsel for a nonprofit mental health agency, and was responsible for advising the Board of Directors and the CEO on issues regarding trustee duties and responsibilities, fiscal matters, debt refinancing, corporate compliance, quality improvement, risk management, employment and labor issues, and Board and Committee bylaws.
  • Serves as outside retained counsel for a large nonprofit, advising on corporate and governance matters; tax compliance; HIPAA and HITECH compliance programs; ethics; labor and employment matters; transactions and contract drafting for IT vendors; probate court matters; consents and waivers; and contract review for HUD related housing grants.
  • Facilitated the design and development of ACO structures for applicant hospitals and physician groups.

Publications & Presentations

Publications

  • “Considerations in Telemedicine Contracting,” Cleveland Metropolitan Bar Journal (March 2019)
  • “Protecting the Provider-Based Status of Your Satellite Outpatient Clinics,” Co-Author, Cleveland Metropolitan Bar Journal (March 2016)
  • “Doctor? It’s Time For Your Annual Check Up…” MD News (March 2016)
  • “ZPIC and RA Audit Appeals: Strategic Considerations,” Cleveland Metropolitan Bar Journal (March 2015)
  • “The Vendor Discount Dilemma,” Long Term Living Magazine (January 2015)
  • “Wracked by RACS?” Long Term Living Magazine (December 2014)
  • “Physician Conflicts of Interest and the Sunshine Act,” MD News (March/April 2014)
  • “The Physician Sunshine Act – Answers to the Five W’s,” Northern Ohio Physician Magazine (July 2013)
  • “Health Plans: Check Your Contracts!” Managed HealthCare Executive Magazine (July 2013)
  • “Medicaid: To Expand or Not to Expand?” Crain’s Cleveland Business Legal Guest Blog (June 2013)

Presentations

  • “Appeal Strategies for ZPIC and RAC Audits,” Ohio Health Care Association Annual Meeting (May 2016)
  • “Revenue Cycle, Compliance, and Audits,” Annual Medical/Legal Summit, Cleveland Metropolitan Bar Association Conference (March 2016)
  • “Billing and Audits Roundtable,” Medical Legal Summit sponsored by the Cleveland Metropolitan Bar Association, The Academy of Medicine Education Foundation, and The Academy of Medicine of Cleveland and Northern Ohio (March 2016)
  • “HIPAA for Self-Insurance,” Roundstone Medical Captive Forum (August 2015)
  • “Access to Treatment: Barriers and Strategies,” LAM Foundation International Patient and Family LAMposium (March 2015)
  • “Fraud and Abuse in Healthcare Operations,” The Impact of Healthcare Reform on Mental Health Services, Association for Ambulatory Behavioral Healthcare, 46th Annual National Conference (July 2014)
  • “The Affordable Care Act,” Continuing Legal Education presentation at the Cleveland-Marshall College of Law (May 2014)
  • “Overview of the Affordable Care Act,” Government Intervention: the “Free Market” Health Care Industry and the Affordable Care Act Seminar (March 2014)
  • “Leadership/Partnerships Across the Care Continuum,” Ohio Hospital Association and the Ohio Department of Mental Health (December 2013)
  • “The Affordable Care Act, What We Know Now,” Council of Small Business Enterprises Annual Convention (October 2013)
  • “Driving, Employment and Medicolegal Aspects of Epilepsy: Case Discussions,” The International Epilepsy Colloquium, a joint initiative between the University Hospitals Case Medical Center, the Marburg Epilepsie Zentrum in Germany, the Lyon University Hospital Institute for Children and Adolescents with Epilepsy – IDEE, and the Grenoble University Hospital in France (May 2013)
  • “The Affordable Care Act: Guidance for Public Employers,” program for public employer clients (April 2013)
  • “The Affordable Care Act: Guidance for Employers,” program for large private sector employer clients (March 2013)
  • “The ACA: Impact on Municipalities,” Ohio Municipal Attorneys Association (March 2013, May 2013)
  • “What Employers Need to Know About Healthcare Reform and Other Major Developments in Employment Law,” (November 2012)
  • “The Affordable Care Act,” Institute of Management Accountants Annual Controllers Workshop (November 2012)
  • “Summary of Benefits & Coverage Webinar,” program hosted by Dawson Companies, Health Care Reform Legislative Review (September 2012)
  • “Ethics and Compliance,” Mental Health Services, Inc. training seminar (2012-2013)
  • “EMTALA and the Psychiatric Patient,” Greater Cincinnati Health Council training seminar (2011)

Involvement

PROFESSIONAL AFFILIATIONS

  • Cleveland State University Cleveland-Marshall College of Law (Adjunct Professor of Health Law I, Health Law II, Psychiatry and the Law, Fraud and Abuse in Health Care, HIPAA, and Law in Medicine, 2006-present)
  • Cleveland-Marshall College of Law Advisory Council for Health Law & Public Policy Center (2009-present)
  • Cleveland Metropolitan Bar Association
  • Ohio State Bar Association
  • American Health Lawyers Association (Vice-Chair, Publications; Behavioral Medicine Task Force)
  • University of Pittsburgh School of Law (Adjunct Professor of Professional Judgment and Ethics, 2017)
  • Cleveland State University School of Nursing Visiting Committee (2017)
  • Lake Erie College (Adjunct Professor of Psychology and the Law and Landmark Cases in Mental Health Law, 2011 to 2013)
  • Ohio Hospital Association (Member; Chair, Behavioral Medicine Work Group, 2004-2005)

COMMUNITY INVOLVEMENT

  • Koinonia (Board of Directors, 2019-present)
  • Emergency Medical Services Outreach Fund of Hudson (Co-Founder, 2010-present)
  • Hudson Community Foundation (Board of Directors, 2010-2013)
  • The Free Clinic (Board of Directors, 2008-2013)
  • Leadership Hudson (Class of 2009-2010)
  • Mental Health Services, Inc. (Board of Directors, 2007-2008)

Honors

  • The Best Lawyers in America©, Health Care Law (2015-2019)
  • Cleveland-Marshall College of Law, Judge Richard Markus Adjunct Faculty Award (2016)
  • Best Lawyers in Northeast Ohio (2016)
  • Cleveland-Marshall College of Law, Health Law Society, Pioneers of Excellence in Health Care Award (2011)