NHI Healthcare Regulations & Compliance 5 — Questions and Answers
Question 1: Which consent is required before a patient can be enrolled in a research study under federal regulations?
- Implied consent
- Informed consent with IRB-approved documentation (Correct answer)
- Verbal consent witnessed by two staff members
- Physician consent on behalf of the patient
Correct answer: Informed consent with IRB-approved documentation
Federal regulations (45 CFR Part 46) require written informed consent approved by an Institutional Review Board (IRB) before enrolling subjects in research studies.
Question 2: A patient bill of rights in a healthcare facility typically does NOT include the right to:
- Receive care without discrimination
- Access their medical records
- Demand experimental treatments not approved by their insurer (Correct answer)
- Be informed about treatment options
Correct answer: Demand experimental treatments not approved by their insurer
Patient rights include non-discrimination, record access, and informed consent for approved treatments, but do not guarantee access to experimental or non-covered treatments.
Question 3: Which of the following best describes a 'Conditions of Participation' (CoP) for Medicare?
- Financial eligibility requirements for Medicare beneficiaries
- Health and safety standards healthcare organizations must meet to receive Medicare payment (Correct answer)
- Rules governing how Medicare premiums are calculated
- Guidelines for Medicare Advantage plan enrollment
Correct answer: Health and safety standards healthcare organizations must meet to receive Medicare payment
Conditions of Participation are health and safety standards established by CMS that healthcare organizations must meet to be certified to participate in Medicare and Medicaid.
Question 4: Under HIPAA, a healthcare provider MAY disclose PHI without patient authorization for which of the following purposes?
- Marketing a new medication to the patient
- Sharing with an employer for workplace injury assessment unrelated to workers' comp
- Reporting to public health authorities to prevent disease spread (Correct answer)
- Selling patient data to a pharmaceutical research firm
Correct answer: Reporting to public health authorities to prevent disease spread
HIPAA permits disclosure of PHI to public health authorities for activities such as disease surveillance, prevention, and control without patient authorization.
Question 5: The minimum necessary standard under HIPAA requires covered entities to:
- Collect only the minimum data needed for billing purposes
- Limit PHI access to the minimum needed to accomplish the intended purpose (Correct answer)
- Provide patients with the minimum amount of information about their diagnosis
- Use the minimum number of staff to handle PHI
Correct answer: Limit PHI access to the minimum needed to accomplish the intended purpose
The minimum necessary standard requires covered entities to make reasonable efforts to limit PHI use, disclosure, and requests to what is minimally necessary for the purpose.
Question 6: Which of the following scenarios represents a potential Stark Law violation?
- A physician refers a patient to a specialist in the same medical group
- A physician refers Medicare patients to a lab in which the physician holds a financial interest, with no applicable exception (Correct answer)
- A hospital employs physicians under a fair market value compensation arrangement
- A physician orders tests at a hospital-owned outpatient facility
Correct answer: A physician refers Medicare patients to a lab in which the physician holds a financial interest, with no applicable exception
A physician referring Medicare patients to a laboratory where the physician has a financial interest, without an applicable Stark Law exception, violates the physician self-referral prohibition.
Question 7: Which document serves as the legal authority for a designated person to make healthcare decisions on behalf of an incapacitated patient?
- Living Will
- Do Not Resuscitate (DNR) Order
- Durable Power of Attorney for Healthcare (Correct answer)
- POLST Form
Correct answer: Durable Power of Attorney for Healthcare
A Durable Power of Attorney for Healthcare (DPAHC) designates a healthcare proxy or agent with legal authority to make medical decisions when the patient lacks decision-making capacity.
NHI Healthcare Regulations & Compliance 5
Which consent is required before a patient can be enrolled in a research study under federal regulations?