Unit 3 Exam

Question 1

What has false claims, fraud, and abuse cost Medicare and Medicaid?

Answer 1

Billions of dollars.

Question 2

What are the three laws that deal with false claims?

Answer 2

1.) False Claims Act - deals with lies and misrepresentations.
2.) Anti-Kickback Statute - deals with bribes and inducements for referral.
3.) Stark Laws - deal with perks and self-referrals.

Question 3

Under the False Claims Act, what can happen if false representation was done knowingly and willfully?

Answer 3

The accused party can be served on the basis of criminal liability.

Question 4

Are there any exceptions to the False Claims Act?

Answer 4

No.

Question 5

What did the court hold in the case of the United States v. Kizek?

Answer 5

In this case, the court held that if Medicare bills are submitted with reckless disregard as to their truth, this would be a violation under the False Claims Act.

Question 6

Under the False Claims Act, a private citizen can bring what?

Answer 6

Qui tam actions for healthcare fraud.

Question 7

A private citizen, referred to as a realtor, can sue the U.S. government and receive what?

Answer 7

A bounty of 15-30% of what the government recovers.

Question 8

What does the Anti-Kickback Statute prohibit?

Answer 8

Knowingly and willfully offering, paying for, soliciting, or receiving anything of value in exchange for referral of healthcare services billable to Medicare and Medicaid. It applies to both sides of an illegal transaction.

Question 9

What are the exceptions to the Anti-Kickback Statute called?

Answer 9

Safe Harbors

Question 10

What did the court rule in the case of United States v. Greber?

Answer 10

In this case, the court ruled that a payment to a referring physician, if done to induce future referrals, is illegal, even if the payment is compensatory.

Question 11

What types of action does the Anti-Kickback Statute have?

Answer 11

It has criminal and administrative action attached to it, as the government is the sole enforcer.

Question 12

What are the Starks Laws?

Answer 12

Stark I and Stark II prohibit physician referrals to clinical labs in which the physician or immediate family member has a financial interest that will generate a bill reimbursable by Medicare and Medicaid.

Question 13

What was Stark II an expansion of?

Answer 13

Stark I prohibitions.

Question 14

How many “designated health services” are covered by Stark?

Answer 14

11

Question 15

What do the Stark Laws impose?

Answer 15

It imposes a civil fine of $15,000 per item billed and exclusion from Medicare/Medicaid participation.

Question 16

What do the Stark Laws have exceptions for?

Answer 16

It has exceptions for self-referral arrangements that pose little risk of abuse.

Question 17

What did the court hold in the case of Roe v. Wade?

Answer 17

In this case, the court held that a state may not, consistent with the Constitution, absolutely prohibit elective abortion.

Question 18

What did the court hold in the case of Planned Parenthood of Southeastern Pennsylvania v. Casey?

Answer 18

In this case, the court held that a state may regulate abortion only when such regulation does place an undue burden on a woman’s ability to terminate her pregnancy before viability.

Question 19

What did the court rule in the case of Smith v. Cote?

Answer 19

In this case, the court ruled that a “wrongful birth” cause of action exists, but a “wrongful life” cause of action does not.

Question 20

What is an example of when the court refuses to enforce a surrogate mother contract due to ethical dilemmas?

Answer 20

The matter of Baby M.

Question 21

What is an example of the court declining to order an individual to undergo a Caesarian section to save the baby’s life?

Answer 21

In Re A.C.

Question 22

What did the court hold in the case of Safer v. Pack?

Answer 22

In this case, the court held that a physician has a duty to warn the child of a patient of a genetic risk.

Question 23

There are cases dealing with discrimination based on genetic traits in what areas?

Answer 23

Insurance and Employment

Question 24

The definition of death has what kind of interpretations?

Answer 24

Legal, medical, and religious.

Question 25

What did the court hold in the case of Cruzan v. Missouri Dept. of Health?

Answer 25

In this case, the court held that a state may require clear and convincing evidence of a comatose patient’s consent prior to a cessation of life support.

Question 26

What did the court hold in the case of Bouvia v. Superior Court?

Answer 26

In this case, the court held that a competent adult may refuse force-feeding done to sustain life, even if not mentally ill.

Question 27

What has to be established in "right to die" cases?

Answer 27

A patient’s capacity to make that choice has to be established.

Question 28

In "right to die" cases, the patient must have the ability to do what?

Answer 28

1.) Communicate and understand the information involved. 2.) Reason and deliberate about the choice.

Question 29

What occurred under the Uniform Health Care Decisions Act?

Answer 29

Under this legislation, an individual may choose an Advanced Healthcare Directive, which is a Power of Attorney for healthcare. Decisions may also be made by a surrogate or a guardian.

Question 30

Based on judicial determination, any healthcare decision will be made by the first person available in what hierarchy?

Answer 30

1.) The patient, if competent. 2.) The patient through an individual instruction. 3.) An agent appointed by the patient in a written power of attorney for healthcare, unless the court has explicitly given this authority to a guardian. 4.) A guardian appointed by the court. 5.) A surrogate appointed orally by the patient. 6.) A surrogate selected from the list of family members and others who can make decisions on behalf of the patient.

Question 31

In the absence of governing statutes, discovering the patient’s wishes depends on a determination of what?

Answer 31

The patient's best interest.

Question 32

What precedents are the determination of a patient's self-interest based on?

Answer 32

1.) Conservatorship of Wendland 2.) In Re Conroy 3.) Guardianship of Shiavo

Question 33

In other life and death decisions, physician assisted suicide has not been recognized as a constitutionally protected fundamental right based on what case?

Answer 33

Washington v. Glucksberg

Question 34

What is the only U.S. state that has a Death with Dignity Act?

Answer 34

Oregon

Question 35

The ethical rules in bioethics include what?

Answer 35

The Nuremberg Code, Declaration of Helsinki, and The Belmont Report.

Question 36

Who can refuse life-saving medical treatment?

Answer 36

Competent Individuals

Question 37

What happens when an individual is no longer competent?

Answer 37

An Advanced Health Directive may be activated.

Question 38

What may a physician do during end-of-life issues?

Answer 38

In end of life issues, a physician may declare brain death based on neurological criteria, whereas a family may insist that based on religious belief a person cannot be declared brain-dead unless they stop breathing.

Question 39

What is in place to prevent conflict of interest in bioethics and research?

Answer 39

An Institutional Review Board (IRB)

Question 40

Under federal law, an institution must do what regarding conflict of interest?

Answer 40

1.) Establish criteria for defining Conflicts of Interest. 2.) Establish a Conflict of Interest committee. 3.) Train members about Conflict of Interest issues. 4.) Include individuals from outside the institution in review and oversight. 5.) Remind members of conflict of interest policies at each meeting. 6.) In human-based research, there may be waivers, FDA “Emergency Research” expectations.

Question 41

What are the special subjects in which rules are in place for?

Answer 41

1.) Pregnant Women 2.) Fetuses 3.) Neonates 4.) Minors 5.) Prisoners

Question 42

An institution should minimize the possibility of what?

Answer 42

1.) Coercion 2.) Undue Influence

Question 43

What must an institution consider having under the Dept. of HHS?

Answer 43

An institution must consider having an independent person involved in the consent process and/or monitoring.

Question 44

What institutions have rules and regulations to prevent conflict of interest?

Answer 44

HHS, FDA, Public Health Service, and the National Science Foundation.

Question 45

The Association of American Medical Colleges - AAMAC has adopted policies and guidelines for oversight of what?

Answer 45

Individual institutional financial interest in human subjects research.

Question 46

What does the AAMAC require institutional policies be?

Answer 46

1.) Comprehensive 2.) Unambiguous 3.) Well-publicized 4.) Consistently applied and enforced.

Question 47

What do other sources of guidance include?

Answer 47

1.) Association of American Universities Task Force Report 2.) American Society of Law, Medicine and Ethics 3.) American Society of Gene Therapy 4.) American College of Emergency Physicians (Financial Conflicts of Interest in Biomedical Research, June 2002).

Question 48

Failure to comply with regulatory requirements can lead to what?

Answer 48

Administrative sanctions from PHS and/or HHS.

Question 49

Failure to comply with regulatory requirements may also lead to civil liability based on undisclosed conflicts. The theories of liability may be based on what?

Answer 49

1.) Lack of Informed Consent 2.) Failure to Follow Federal Regulations 3.) Negligence 4.) Fraud - Concealment

Question 50

Prudent risk management requires attention to what?

Answer 50

Compliance

Question 51

There is also the potential exposure of what regarding risk management?

Answer 51

An Institution, Investigators, Supervisors, Institutional Review Board Members.

Question 52

A primary role in the delivery of healthcare involves health information contained in what?

Answer 52

A paper health record, an electronic health record, or an abstract of patient-specific information.

Question 53

Health information maintained in respective formats serves as the what?

Answer 53

A healthcare provider’s legal record of patient care.

Question 54

Due to the multiple functions and uses of the health records, it is referred to as?

Answer 54

1.) Medical Record 2.) Hospital Chart 3.) Outpatient Record 4.) Clinical Record 5.) Electronic Health Record (EHR) 6.) Computerized Patient Record.

Question 55

The health record is a document that contains a complete and accurate description of a patient’s history, which includes what?

Answer 55

1.) Condition 2.) Diagnosis 3.) Therapeutic treatment and the results of treatment.

Question 56

Does the health record serve both clinical and non-clinical purposes?

Answer 56

Yes.

Question 57

What can health records assist the public health community with?

Answer 57

The controlling of disease and the monitoring of the health status of a population.

Question 58

What are the five legal requirements that govern health records?

Answer 58

1.) Statutory Provisions 2.) Regulations 3.) Accrediting Standards 4.) Institutional Standards 5.) Professional Guidelines

Question 59

What are statutory provisions?

Answer 59

These may be federal or state laws, or municipal codes.

Question 60

What are regulations?

Answer 60

They are enacted by executive branch agencies and are found at both the federal and state levels. These regulations vary between: 1.) General statements that a health record be maintained 2.) Broad listings of content requirements. 3.) Specific, detailed provisions that govern content. At the federal level, an example of a detailed provision was enacted by the Dept. of HHS as a Condition of Participation in the Medicare program.

Question 61

What are accrediting standards?

Answer 61

They are frequently used to establish the standard of care in negligence suits against healthcare providers. Voluntary accrediting body is the American Osteopathic Association’s Healthcare Facilities Accreditation Program.

Question 62

What are institutional standards?

Answer 62

Where no specific statute or regulation specifically addresses the existence or content of a health record, healthcare institutions may create their own standards or adopt the standards issued by an accrediting agency.

Question 63

What are professional guidelines?

Answer 63

Professional Health Organizations publish guidelines that address the existence and content of health records . Example: The American Health Information Management Association publishes position papers and practice briefs about health record content. Health records need to be timely and complete.

Question 64

All entries in a health record must be what?

Answer 64

1.) Authored: Authorship identifies the healthcare provider who made the entry, either in writing, by dictation, by keyboard, or by keyless data entry. 2.) Authenticated: Authentication confirms the content of the entry, either by written signature, initials, or computer-generated signature code.

Question 65

In some localities, the licensing authority may consider authentication to include the use of what?

Answer 65

A rubber stamp signature by a medical staff member.

Question 66

Controlling statutes and regulations may specify or recommend the method of what?

Answer 66

Method of destruction, i.e. shredding, burning, or recycling.

Question 67

Some laws may require the hospital to do what prior to destroying patient records?

Answer 67

The creation of an abstract of patient data or the notification of the patient in question.

Question 68

Under HIPAA's Security Rule, when is data permitted to be destroyed?

Answer 68

Data are only destroyed after the retention period has expired, using only those methods specified in the information security policy.

Question 69

What are the methods pertaining to the destruction of paper-based health records?

Answer 69

Dissolving the records in acid or burning, pulverizing or shredding the records such that the data is unreadable or cannot be reconstructed before being discarded.

Question 70

What are the methods pertaining to the destruction of electronic health records?

Answer 70

The methods may include clearing using software or hardware to overwrite nonsensitive data, purging by magnetic means, and destruction of the electronic media by disintegration, pulverization, melting, incinerating, or shredding.

Question 71

The obligation to properly destroy protected health information applies to what?

Answer 71

Computers, photocopy machines, fax machines, smart phones, and tablets if they contain protected health information.

Question 72

The healthcare institution should retain permanent evidence of the record’s destruction such as what?

Answer 72

A certificate of destruction.

Question 73

Destruction of health data may also occur because of what?

Answer 73

A change in ownership of a healthcare provider.