Medical Ethics

Medical ethics and biomedical ethics and the Standard of Care regarding:

    • Patient privacy under HIPAA, Hybrid Entities under HIPAA and the Privacy Shield Standard as well as State privacy standards
    • Conflicts of interest in serving as a Independent Review Organization (IRO) for the provider’s own patients
    • Payments and inducements to provide vaccinations to non-U.S. citizens
    • Conflicts of interest and self-referral under Stark Law and the Anti-Kickback Statute

Autonomy, beneficence, non-maleficence and justice, the four main principles of bioethics, are often utilized to shape our decision making within the medical field. While one does not take precedence over another, the concept of autonomy or self-rule has become the basis of patient decision making. Respecting autonomy allows patients to make decisions that are in their best interests, as they are usually the best judges of those interests.[i]   In medicine a patient’s autonomy is the basis of decision making, but there remain many other factors that the physician is responsible for in this process. The physician needs to ensure the patient truly understands, taking the time when needed to counsel and listen to patients so that they can make informed decisions that correspond with their goals and values. [ii]

At the same time, there are many personal factors (e.g., commitment to the Hippocratic principles of beneficence and non-maleficence, surgeon autonomy in the operating room, non-abandonment) the surgeon faces that while not always discussed with their patients impact the surgeon, especially when contemplating surgical intervention in advanced illness. For surgeons taking care of patients facing the prospect of a palliative procedure or any surgical intervention at the end-of-life, there remains a lack of scientific data to guide decision making. Once a decision has been made, the surgeon retains a sense of responsibility to the patient to care for them not just during the operation, but afterwards. The unfortunate reality for patients in these situations is the poor outcomes many face and even though surgeons’ strongest desires are to fix their patients, death cannot be ‘fixed’. Ultimately, one must remember that often what patients near the end-of-life need most is for their physicians and surgeons to be sources of support during this time. [iii]

These ethical Standards apply to patient referrals and transfers to care.[iv]

[i] Wancata, L. M., & Hinshaw, D. B. (2016). Rethinking autonomy: decision making between patient and surgeon in advanced illnesses. Annals of translational medicine, 4(4), 77.

[ii] Id.

[iii] Id.

[iv] XNnate D. A. (2021). Treatment withdrawal of the patient on end of life: An analysis of values, ethics and guidelines in palliative care. Nursing open, 8(3), 1023–1029.  “Owing to his underlying health condition, a further assessment of James’ mental status showed that he seemed to lack capacity to express his preferences for care and a suggestion was to be made on transferring him to a hospice for end of life care. Although there was no formal advance statement about his future care needs, it was made known to the charge nurse by a relative that James wished not to spend his last days in a hospice but in his home. In such a situation, relatives who are not legally appointed as the patient’s welfare guardian may give relevant information about the patient’s previously expressed wishes, beliefs, values and preferences”

Michael F. Arrigo

Michael Arrigo, an expert witness, and healthcare executive, brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health I.T., and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations that provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and billing, fraud damages, and electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, malpractice, and insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software S.A. (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for the top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls I.T. audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto-economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and published in Healthcare I.T. News. Mr. Arrigo serves as a member of the board of directors of a publicly traded company in the healthcare and data analytics industry, where his duties include: member, audit committee; chair, compensation committee; member, special committee.

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