Question 1

Powers granted to both the federal and state governments are known as what?&#10;A) Conditional powers&#10;B) Concentric powers&#10;C) Concurrent powers&#10;D) Conflicting powers

Accepted Answer

Concurrent powers are given to both the federal and state governments at the same time, such as the ability to regulate the privacy of PHI.

Question 2

By what legal code or precedent are powers not granted to the federal government reserved by the states?&#10;A) HIPAA&#10;B) HITECH&#10;C) The 10th Amendment to the U.S. Constitution&#10;D) The Stark Law

Accepted Answer

The 10thAmendment to the U.S. Constitution, known as the reserved powers clause, reads as follows: "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

Question 3

Which is true of guidance documents?&#10;A) They are official agency publications.&#10;B) They are identical to regulations and rulemaking.&#10;C) They are legally binding.&#10;D) They come from the U.S. Congress.

Accepted Answer

Guidance documents may resemble rulemaking, but they are non-legally binding documents produced by agencies, in order to help subjects understand and comply with specific regulations.

Question 4

Which of the following is true regarding administrative enforcement?&#10;A) There is an additional route of appeal if a decision is issued in an administrative proceeding as opposed to a federal court proceeding.&#10;B) There are fewer routes of appeal if a decision is issued in an administrative proceeding as opposed to a federal court proceeding.&#10;C) Administrative settlement agreements include the finding of liability against an entity.&#10;D) An administrative proceeding is more formal than a court proceeding.

Accepted Answer

Administrative proceedings and court proceedings are functionally equivalent. The same remedies are available to both the federal court judge and the administrative law judge. However, the administrative system offers an additional route of appeal regarding decisions, when compared to the court system.

Question 5

E-mailing fraudulent claims from an office in Houston, Texas, to a Medicare facility in Washington, D.C., for medical care not actually performed would constitute what?&#10;A) A civil but not criminal infringement&#10;B) Wire fraud as well as a violation of the False Claims Act&#10;C) Only wire fraud&#10;D) Unbundling

Accepted Answer

Such interstate e-mailing of fraudulent information would be wire fraud as well as a breach of the False Claims Act. Such a breach could be a civil as well as criminal case. Unbundling involves fraudulently increasing revenue by separately billing for individual parts of a typically bundled service, which isn't what is happening in the question.

Question 6

A vendor provided all advanced practice registered nurses with free mobile devices to stimulate referrals. Which regulation is being violated?&#10;A) The Anti-Kickback Statute&#10;B) The Stimulus Act&#10;C) The HITECH Act&#10;D) HIPAA

Accepted Answer

The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a federal healthcare program. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a federal healthcare program, the Anti-Kickback Statute is violated.

Question 7

Which of the following would be regulated by the FDA?&#10;A) A health information website&#10;B) An app that functions as a medical device&#10;C) A FitBit&#10;D) Google Glasses

Accepted Answer

Only mHealth applications that are considered medical devices, such as electrocardiograms, can be regulated by the FDA.

Question 8

Which agencies can accredit hospitals for participation in Medicare and Medicaid programs? (Select all that apply.)&#10;A) The Joint Commission&#10;B) Det Norske Veritas&#10;C) Safe Harbors&#10;D) Federal Trade Commission&#10;E) National Coordinator for Health Information

Accepted Answer

The Joint Commission (TJC) and Det Norske Veritas (DNV) are the only two agencies that the Center for Medicare and Medicaid Services has authorized to accredit hospitals.

Question 9

The Stark Law considers which of the following Designated Health Services? (Select all that apply.)&#10;A) Physical therapy services&#10;B) Housecleaning and janitorial services&#10;C) Home health services&#10;D) Prosthetic devices and supplies&#10;E) Medical language translation services

Accepted Answer

The Stark Law governs physician self-referral for Medicare and Medicaid patients. Its "Designated Health Services" cover a variety of topics, including physical therapy, home health, and prosthetic devices. It does not involve language translation or any kind of housekeeping services that convalescing patients may need.

Question 10

Which of the following would the FDA consider a Class II medical device? (Select all that apply.)&#10;A) A device of medium safety risk&#10;B) A callus remover&#10;C) A powered wheelchair&#10;D) Items needing premarket approval&#10;E) A titanium implant

Accepted Answer

Class II devices are considered medium risk by the FDA and require general controls as well as special controls. A powered wheelchair falls in this category. A callus remover would be a Class I low-risk device, whereas an implant meant to be surgically placed inside a patient would be considered a Class III high-risk device.

Deck 25: Legal Issues, Federal Regulations, and Accreditation