Key Legal Frameworks in Healthcare and Research Ethics

Americans with Disabilities Act (ADA)

The Americans with Disabilities Act (ADA) was passed on July 26, 1990. Prohibits discrimination against peoples with disabilities.

ADA National Network

The ADA is a civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the public.

Protected Class

Individuals with disabilities are members of a protected class, which is a group of individuals to whom Congress or a state legislature has given legal protection against discrimination or retaliation.

Healthcare Workers and ADA

Health care workers need to understand issues around the application of the ADA beyond physical access, including their roles in providing accommodations to ensure equal access to health care for people with disabilities.

Barriers in Accessing Healthcare Services

Barriers include transportation to access healthcare services, parking, accessibility to buildings, and inadequate access to health care information - health literacy intervention.

Accessibility in Healthcare Services

Healthcare providers must make services accessible through effective communication, accommodating service animals, and ensuring equal access.

Effective Communication

Healthcare providers must provide services to deaf patients through a qualified interpreter.

Accommodating Service Animals

In a hospital, there may be certain areas where having a service animal could jeopardize safety, such as in the sterile environment of an operating room.

Fraud Enforcement and Recovery Act

The intent of the Fraud Enforcement and Recovery Act is to reduce fraud involving federal funds and property.

False Claims Act

The Fraud Enforcement and Recovery Act clarifies that the FCA covers false claims for government money or property, regardless of whether the claim was presented to a government employee or official.

Grounds for Liability under Fraud Act

The Fraud Enforcement and Recovery Act expands the definition of 'Claim' to include false records or claims made to the Government or to a contractor or other recipients of federal funds.

Reverse False Claim

The Fraud Enforcement and Recovery Act explicitly states that it is a violation to improperly avoid or decrease an obligation to pay or transmit money or property to the Government.

Definition of Obligation

The Fraud Enforcement and Recovery Act expands the definition of 'Obligation' to include an established duty arising from the retention of any overpayment.

Major Antitrust Laws

The major Antitrust Laws include the Sherman Act, Federal Trade Commission Act, and The Clayton Act.

Purpose of Antitrust Laws

The purpose of the Antitrust Laws is to protect the process of competition for the benefit of consumers, ensuring strong incentives for businesses to operate efficiently, keep prices down, and maintain high quality.

Sherman Act Prohibition

The Sherman Act outlaws monopolistic business practices, including entering into contracts or conspiring to restrain trade.

Common Violations under Sherman Act

Common violations under the Sherman Act include competing individuals or competing companies fixing prices, dividing markets, or rigging bids.

Price Fixing

An agreement (written, verbal, or inferred) among competitors to raise, lower, or stabilize prices or competitive terms.

Market Division

When competitors divide the markets among themselves.

Bid Rigging

When competitors agree in advance who will win a bid.

Criminal penalties for violating the Sherman Act

Up to $100 million fine for corporations; up to $1 million fine for individuals or 10 years in prison (or both).

Federal Trade Commission Act (FTC Act)

Bans unfair methods of competition and unfair or deceptive acts or practices.

Violations of the Sherman Act under the FTC Act

All violations of the Sherman Act also violate the FTC Act, with additional activities or conduct that do not meet the standards of the Sherman Act being violations of the FTC Act.

Enforcers of Antitrust Laws

Both the FTC and the U.S. Department of Justice (DOJ) Antitrust Division enforce federal antitrust laws.

Prosecutors of antitrust violations in health care

The FTC prosecutes antitrust violations in health care, pharmaceuticals, professional services, food, energy, and high-tech industries.

DOJ jurisdiction in certain industries

The DOJ has sole antitrust jurisdiction in industries like telecommunications, banks, railroads, and airlines.

Clayton Act

Addresses specific practices that the Sherman Act does not clearly prohibit, such as mergers and interlocking directorates.

Clayton Act prohibitions

Prohibits mergers and acquisitions where the effect may substantially lessen competition or tend to create a monopoly.

Large companies under the Clayton Act

Large companies must notify the government of their plans in advance of mergers.

Private companies under the Clayton Act

Private companies and individuals may sue for triple damages when they have been harmed by conduct that violates either the Sherman or Clayton Act.

Stark Law

Prohibits physicians from referring patients to receive designated health services payable by Medicare or Medicaid from facilities with which the physician or an immediate family member has a financial relationship, unless an exception applies.

Financial relationship under Stark Law

Includes ownership/investment interest and compensation arrangements.

Consequence of violating the Stark Law

Results in a false claim under the False Claims Act.

Intent under the Stark Law

Proof of intent to violate the Stark Law is not required for prosecution.

Anti-Kickback Statute (AKS)

Prohibits the knowing and willful payment to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs.

Remuneration

Includes anything of value, such as cash, free rent, hotel stays, meals, excessive compensation for work, or other services.

AKS

Under the AKS, both the payers of kickbacks and the recipients of the payment, or individuals who solicit payment for referrals, may be prosecuted.

Intent under AKS

Intent is a key element of liability under the AKS.

Violation of AKS

Violation of the AKS results in a false claim under the False Claims Act.

Sarbanes-Oxley Act (SOX)

The Sarbanes-Oxley Act of 2002 is intended to increase the accountability of corporate executives and board members for their actions by implementing a checks and balances system.

SOX requirements for corporate managers

SOX requires corporate managers and executives to personally attest to the accuracy of their company's financial statements.

Fraudulent financial statements under SOX

Managers and executives who sign fraudulent statements can be prosecuted.

National Research Act of 1974

The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Belmont Report creation

The Tuskegee Syphilis Study led to the creation of the Belmont Report after it was revealed that the U.S. Public Health Service conducted unethical research on black men without informed consent.

Three basic ethical principles for research

Respect for Persons, Beneficence, Justice.

Application of ethical principles in research

Informed Consent, Assessment of Risk and Benefits, Selection of Subjects, Research Compliance.

Respect for Persons

Individuals should be treated as autonomous agents and are entitled to protection if their ability to govern themselves is diminished.

Principle of Beneficence in research

The principle of Beneficence is an obligation to secure the well-being and protect from harm research subjects.

Assessing risks and benefits

The assessment must include the gathering of systematic and comprehensive information about proposed research to determine if the risks are justified.

MOLST in New York State

The Medical Orders for Life-Sustaining Treatment (MOLST) is used for patients with serious health conditions who want to avoid or receive life-sustaining treatment.

Health Care Proxy Law

A living will is a written statement of an individual's wishes about healthcare treatment. A health care proxy must carry out the wishes in a living will.

Family Health Care Decisions Act (FHCDA)

The Family Health Care Decisions Act allows a close friend or family member to make health care decisions for a patient who has not signed a health care proxy.

Never Events in healthcare

Never events are errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, indicating a real problem in safety and credibility.

Penalties for failure to report in New York

Anyone who fails to report suspected child abuse or maltreatment may be charged with a Class A misdemeanor and subject to criminal penalties.