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Flashcards for reviewing Chapter Four: Regulation Issues, the Law, and Practice Management.
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How is healthcare characterized in terms of regulation in the United States?
Healthcare is one of the most heavily regulated industries in the U.S.
What is the definition of jurisdiction in practice management?
The governmental unit that is empowered to make & enforce regulations.
Legal issues in practice management fall under what two main categories?
General applications of the law and specific applications of the law.
Which level of government plays a major role in regulating healthcare according to the lecture notes?
States.
What license is required by most cities for businesses?
Business Licenses.

What actions are tracked under "Adverse Actions" in the National Provider Data Bank (NPDB)?
Actions against provider's license, privileges, or certifications.
What malpractice information is tracked by the National Provider Data Bank (NPDB)?
Medical Malpractice Payment (payments made for malpractice claims).
What types of criminal convictions are tracked by the National Provider Data Bank (NPDB)?
Federal or state convictions.
Name the parties and agreements mentioned as falling under Contract Law for medical practices.
Government payers, commercial payers (insurance companies), other healthcare organizations, medical supply companies, equipment leasing companies, and staff (in the form of employment agreements).
What is the general rule regarding local, state, and federal taxation for medical practices?
Medical practices are subject to ALL local, state & federal rules & regulations on taxation, which vary by state.
What does the Sherman Act prohibit?
Price-fixing & monopolistic practices.
What does the Clayton Act do regarding antitrust law?
Expands on the Sherman Act rules & enforcements.
What is the purpose of the Robertson-Patman Act?
Protects small businesses from unfair pricing practices.
What practices are outlawed by the Federal Trade Commission Act?
Unfair trade practices & unfair competition.
What requirement does the Hart-Scott-Rodino Act place on large corporations?
Requires large corporations to report mergers to the FTC.
What three main issues do labor laws address in employment?
Fair employment practices, wage and hour rules, and nondiscrimination in hiring & employment.
What protection does the Americans with Disabilities Act of 1990 provide?
Protects people with disabilities from discrimination in hiring/firing.
What is the role of the Occupational Safety and Health Administration (OSHA)?
Enforces regulations related to workplace health & safety.
What protection is provided by the Family and Medical Leave Act (FMLA)?
Offers protection for employees who request a leave of absence to deal with health-related issues.
Which three important laws governing medical practice are highlighted in Chapter Four?
False Claims Act, Anti-Kickback Statute, and Stark Law.
During what historical era was the False Claims Act created?
The Civil War.
What conduct is penalized by the False Claims Act?
Penalizes those who knowingly submit false claims to the U.S. government.
What does the Stark Law prohibit healthcare providers from doing?
Prohibits providers from referring patients to certain services in which they or their family have a financial interest.
Which agency is primarily responsible for enforcing the Stark Law?
Centers for Medicare & Medicaid Services (CMS).
To which programs does the Anti-Kickback Statute (AKS) apply?
All federal programs & those doing business with the government.
To which specific programs does the Stark Law apply?
Medicare & Medicaid programs.

How do the intent requirements compare between the Anti-Kickback Statute and the Stark Law in Exhibit 4.2?
For the Anti-Kickback Statute, intent must be proven (knowing and willful). For the Stark Law, there is no intent standard for overpayment (strict liability), but intent is required for civil monetary penalties for knowing violations.
What criminal penalties can be enforced under the Anti-Kickback Statute according to Exhibit 4.2?
Fines up to $25,000 per violation and up to a 5 year prison term per violation.
In what year was HIPAA enacted, and what does it establish accountability for?
Enacted in 1996, HIPAA establishes strict rules & accountability for protecting patient health information (PHI) in any form (written, oral, or electronic).
Under HIPAA, what three principal areas allow for sharing Patient Health Information (PHI) on an as-needed basis?
Treatment, Payment, and Healthcare Operations.
What activities are included under "Healthcare Operations" in HIPAA regulations?
Activities needed to run a medical practice, such as audits, quality improvement & business functions.
How is malpractice defined, and what two areas should practice leaders focus on to reduce malpractice risk?
Malpractice is defined as professional activity that is careless, illegal, or improper. To reduce risk, focus should be placed on Communications and Professional Commitment.
What are the key provisions and prohibitions of The Medical Practices Act?
It requires all practicing physicians in the U.S. to be licensed, prohibits splitting of bills for services between providers, and regulates marketing, management relationships, fee sharing, and related arrangements.
What is the primary purpose of Certificate of Need (CON) laws?
To encourage effective allocation of healthcare resources by requiring a CON for hospital or health system building projects that expand practice capacity.
Which five risk domains should be considered when establishing a risk mitigation program?
Malpractice risk, risk due to the physical environment, employee safety & security, financial risk, and compliance risk.
What are the three primary forms of medical malpractice insurance, and which is the most common?
Claims Made Coverage (most common), Occurrence Coverage, and Extended Reporting Endorsements.