Unit 3 Exam Flashcards
What has false claims, fraud, and abuse cost Medicare and Medicaid?
Billions of dollars.
What are the three laws that deal with false claims?
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.
Under the False Claims Act, what can happen if false representation was done knowingly and willfully?
The accused party can be served on the basis of criminal liability.
Are there any exceptions to the False Claims Act?
No.
What did the court hold in the case of the United States v. Kizek?
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.
Under the False Claims Act, a private citizen can bring what?
Qui tam actions for healthcare fraud.
A private citizen, referred to as a realtor, can sue the U.S. government and receive what?
A bounty of 15-30% of what the government recovers.
What does the Anti-Kickback Statute prohibit?
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.
What are the exceptions to the Anti-Kickback Statute called?
Safe Harbors
What did the court rule in the case of United States v. Greber?
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.
What types of action does the Anti-Kickback Statute have?
It has criminal and administrative action attached to it, as the government is the sole enforcer.
What are the Starks Laws?
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.
What was Stark II an expansion of?
Stark I prohibitions.
How many “designated health services” are covered by Stark?
11
What do the Stark Laws impose?
It imposes a civil fine of $15,000 per item billed and exclusion from Medicare/Medicaid participation.
What do the Stark Laws have exceptions for?
It has exceptions for self-referral arrangements that pose little risk of abuse.
What did the court hold in the case of Roe v. Wade?
In this case, the court held that a state may not, consistent with the Constitution, absolutely prohibit elective abortion.
What did the court hold in the case of Planned Parenthood of Southeastern Pennsylvania v. Casey?
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.
What did the court rule in the case of Smith v. Cote?
In this case, the court ruled that a “wrongful birth” cause of action exists, but a “wrongful life” cause of action does not.
What is an example of when the court refuses to enforce a surrogate mother contract due to ethical dilemmas?
The matter of Baby M.
What is an example of the court declining to order an individual to undergo a Caesarian section to save the baby’s life?
In Re A.C.
What did the court hold in the case of Safer v. Pack?
In this case, the court held that a physician has a duty to warn the child of a patient of a genetic risk.
There are cases dealing with discrimination based on genetic traits in what areas?
Insurance and Employment
The definition of death has what kind of interpretations?
Legal, medical, and religious.
What did the court hold in the case of Cruzan v. Missouri Dept. of Health?
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.
What did the court hold in the case of Bouvia v. Superior Court?
In this case, the court held that a competent adult may refuse force-feeding done to sustain life, even if not mentally ill.
What has to be established in “right to die” cases?
A patient’s capacity to make that choice has to be established.
In “right to die” cases, the patient must have the ability to do what?
1.) Communicate and understand the information involved.
2.) Reason and deliberate about the choice.
What occurred under the Uniform Health Care Decisions Act?
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.
Based on judicial determination, any healthcare decision will be made by the first person available in what hierarchy?
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.
In the absence of governing statutes, discovering the patient’s wishes depends on a determination of what?
The patient’s best interest.
What precedents are the determination of a patient’s self-interest based on?
1.) Conservatorship of Wendland
2.) In Re Conroy
3.) Guardianship of Shiavo
In other life and death decisions, physician assisted suicide has not been recognized as a constitutionally protected fundamental right based on what case?
Washington v. Glucksberg
What is the only U.S. state that has a Death with Dignity Act?
Oregon
The ethical rules in bioethics include what?
The Nuremberg Code, Declaration of Helsinki, and The Belmont Report.
Who can refuse life-saving medical treatment?
Competent Individuals
What happens when an individual is no longer competent?
An Advanced Health Directive may be activated.
What may a physician do during end-of-life issues?
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.
What is in place to prevent conflict of interest in bioethics and research?
An Institutional Review Board (IRB)
Under federal law, an institution must do what regarding conflict of interest?
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.
What are the special subjects in which rules are in place for?
1.) Pregnant Women
2.) Fetuses
3.) Neonates
4.) Minors
5.) Prisoners
An institution should minimize the possibility of what?
1.) Coercion
2.) Undue Influence
What must an institution consider having under the Dept. of HHS?
An institution must consider having an independent person involved in the consent process and/or monitoring.
What institutions have rules and regulations to prevent conflict of interest?
HHS, FDA, Public Health Service, and the National Science Foundation.
The Association of American Medical Colleges - AAMAC has adopted policies and guidelines for oversight of what?
Individual institutional financial interest in human subjects research.
What does the AAMAC require institutional policies be?
1.) Comprehensive
2.) Unambiguous
3.) Well-publicized
4.) Consistently applied and enforced.
What do other sources of guidance include?
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).
Failure to comply with regulatory requirements can lead to what?
Administrative sanctions from PHS and/or HHS.
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?
1.) Lack of Informed Consent
2.) Failure to Follow Federal Regulations
3.) Negligence
4.) Fraud - Concealment
Prudent risk management requires attention to what?
Compliance
There is also the potential exposure of what regarding risk management?
An Institution, Investigators, Supervisors, Institutional Review Board Members.
A primary role in the delivery of healthcare involves health information contained in what?
A paper health record, an electronic health record, or an abstract of patient-specific information.
Health information maintained in respective formats serves as the what?
A healthcare provider’s legal record of patient care.
Due to the multiple functions and uses of the health records, it is referred to as?
1.) Medical Record
2.) Hospital Chart
3.) Outpatient Record
4.) Clinical Record
5.) Electronic Health Record (EHR)
6.) Computerized Patient Record.
The health record is a document that contains a complete and accurate description of a patient’s history, which includes what?
1.) Condition
2.) Diagnosis
3.) Therapeutic treatment and the results of treatment.
Does the health record serve both clinical and non-clinical purposes?
Yes.
What can health records assist the public health community with?
The controlling of disease and the monitoring of the health status of a population.
What are the five legal requirements that govern health records?
1.) Statutory Provisions
2.) Regulations
3.) Accrediting Standards
4.) Institutional Standards
5.) Professional Guidelines
What are statutory provisions?
These may be federal or state laws, or municipal codes.
What are regulations?
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.
What are accrediting standards?
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.
What are institutional standards?
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.
What are professional guidelines?
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.
All entries in a health record must be what?
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.
In some localities, the licensing authority may consider authentication to include the use of what?
A rubber stamp signature by a medical staff member.
Controlling statutes and regulations may specify or recommend the method of what?
Method of destruction, i.e. shredding, burning, or recycling.
Some laws may require the hospital to do what prior to destroying patient records?
The creation of an abstract of patient data or the notification of the patient in question.
Under HIPAA’s Security Rule, when is data permitted to be destroyed?
Data are only destroyed after the retention period has expired, using only those methods specified in the information security policy.
What are the methods pertaining to the destruction of paper-based health records?
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.
What are the methods pertaining to the destruction of electronic health records?
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.
The obligation to properly destroy protected health information applies to what?
Computers, photocopy machines, fax machines, smart phones, and tablets if they contain protected health information.
The healthcare institution should retain permanent evidence of the record’s destruction such as what?
A certificate of destruction.
Destruction of health data may also occur because of what?
A change in ownership of a healthcare provider.
