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ABPS Administrative Medicine study materials
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ABPS Administrative Medicine practice questions

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Question 1Health Care Delivery Systems and Organization

Which payment model pays a provider a fixed amount per patient per month regardless of how many services that patient uses?

  1. Pay-for-performance
  2. Capitation Correct answer.
  3. Fee-for-service
  4. Bundled payment

Explanation

Capitation transfers utilization risk to the provider by paying a set per-member-per-month amount for a defined panel. Fee-for-service instead pays per unit of service delivered.

Question 2Health Care Delivery Systems and Organization

A health plan that contracts with physicians and hospitals and then assumes financial risk for enrollees is best described as which type of organization?

  1. A health maintenance organization Correct answer.
  2. A third-party administrator
  3. A preferred provider organization
  4. An accountable care organization

Explanation

An HMO both arranges and finances care for a defined population, accepting risk through capitated or prepaid arrangements. PPOs contract for discounted rates but generally do not assume population risk in the same way.

Question 3Health Care Delivery Systems and Organization

Under Medicare, which part covers outpatient physician services and durable medical equipment?

  1. Part C
  2. Part A
  3. Part B Correct answer.
  4. Part D

Explanation

Medicare Part B is the supplementary medical insurance component covering physician services, outpatient care, and durable medical equipment. Part A covers inpatient hospital care.

Question 4Health Care Delivery Systems and Organization

Which federal-state program provides health coverage primarily to low-income children and pregnant women, with eligibility set by each state?

  1. The Veterans Health Administration
  2. TRICARE
  3. CHIP Correct answer.
  4. Medicare

Explanation

CHIP is a joint federal-state program that extends coverage to children and pregnant women in families with incomes above Medicaid thresholds. States define eligibility and benefit design within federal parameters.

Question 5Health Care Delivery Systems and Organization

In the US health care system, which sector is the single largest payer of health care costs?

  1. Out-of-pocket spending
  2. State and local governments
  3. The federal government Correct answer.
  4. Private health insurance

Explanation

The federal government, through Medicare, Medicaid, and other programs, is the largest single payer of national health expenditures. Private insurance is large but smaller as a single payer.

Question 6Health Care Delivery Systems and Organization

What is the primary purpose of credentialing a physician for a health plan network?

  1. To assign the physician to a hospital call schedule
  2. To determine the physician's malpractice premium
  3. To set the physician's compensation level
  4. To verify qualifications and licensure before granting network participation Correct answer.

Explanation

Credentialing verifies licensure, training, and good standing so the plan can confirm a clinician meets participation standards. It is a verification process, not a compensation or scheduling function.

Question 7Health Care Delivery Systems and Organization

A physician group that owns its own facilities and contracts directly with employers and payers is best described as which model?

  1. A pharmacy benefit manager
  2. A staff-model HMO
  3. A management services organization
  4. An integrated delivery system Correct answer.

Explanation

An integrated delivery system links physicians, hospitals, and other facilities under common ownership to coordinate care across the continuum. It contracts with payers for the combined services.

Question 8Health Care Delivery Systems and Organization

Which entity typically administers Medicaid eligibility determinations and provider payment rates?

  1. The local hospital association
  2. The Centers for Medicare & Medicaid Services alone
  3. The state Medicaid agency Correct answer.
  4. The Joint Commission

Explanation

Medicaid is jointly financed but state-administered, so each state agency sets eligibility rules within federal limits and establishes payment rates. CMS provides federal oversight and matching funds.

Question 9Health Care Delivery Systems and Organization

A patient enrolls in a Medicare Advantage plan. Which statement best describes how that plan delivers benefits?

  1. It provides Part A and Part B benefits through a private plan, often with extra services Correct answer.
  2. It covers only prescription drugs
  3. It requires the patient to forgo Original Medicare enrollment permanently
  4. It replaces Part A with private hospital coverage only

Explanation

Medicare Advantage plans receive a capitated payment to deliver at least the Part A and Part B benefit package, and many add supplemental benefits. Enrollees retain Medicare rights and may return to Original Medicare during enrollment periods.

Question 10Health Care Delivery Systems and Organization

A hospital accepts a single negotiated payment to cover all services for a knee replacement, from admission through 90 days post-discharge. This arrangement is best termed which of the following?

  1. Bundled payment Correct answer.
  2. Global budget
  3. Retrospective cost-based reimbursement
  4. Capitation

Explanation

Bundled payments set one price for a defined episode of care across multiple providers and settings. This creates incentives to coordinate care and avoid unnecessary post-acute utilization.

Question 11Health Care Delivery Systems and Organization

Under the Stark Law, which situation most clearly creates a prohibited financial relationship?

  1. A group practice pays employed physicians a productivity-based salary
  2. A hospital provides a physician with a recruitment loan under a written agreement
  3. A physician refers patients to a lab in which the physician has an ownership interest Correct answer.
  4. A hospital leases office space from a referring physician at fair market value

Explanation

The Stark Law bars physician self-referral for designated health services when the physician has a financial relationship with the entity, absent an exception. Ownership in a referral lab is a classic prohibited arrangement.

Question 12Health Care Delivery Systems and Organization

Which statement best describes the role of a primary care gatekeeper in a traditional HMO?

  1. The gatekeeper negotiates hospital rates
  2. The gatekeeper sets insurance premiums for the plan
  3. The gatekeeper adjudicates claims for the payer
  4. The gatekeeper approves specialist referrals and coordinates the patient's care Correct answer.

Explanation

In gatekeeping models, the primary care physician manages access to specialists and coordinates care to control utilization. This role is clinical and administrative at the point of care, not financial underwriting.

Question 13Health Care Delivery Systems and Organization

A health system wants to share in savings achieved by reducing avoidable readmissions for a Medicare population while meeting quality benchmarks. Which model fits this goal?

  1. Emergency Medical Treatment and Labor Act
  2. Clinical Laboratory Improvement Amendments
  3. Health Professional Shortage Area designation
  4. Medicare Shared Savings Program ACO Correct answer.

Explanation

The Shared Savings Program rewards ACOs that lower spending below benchmarks while meeting quality standards. It is the primary Medicare vehicle for accountable care savings arrangements.

Question 14Health Care Delivery Systems and Organization

Which of the following best characterizes a preferred provider organization (PPO) network?

  1. Enrollees are assigned a gatekeeper who authorizes all specialty care
  2. Enrollees may use out-of-network providers at a higher cost share Correct answer.
  3. Enrollees receive care only from salaried plan-employed physicians
  4. Enrollees must use network providers exclusively to receive any coverage

Explanation

PPOs contract discounted rates with a network but allow out-of-network use with reduced benefits or higher cost sharing. This flexibility distinguishes them from closed-panel HMO models.

Question 15Health Care Delivery Systems and Organization

What is the primary function of a health plan's utilization management program?

  1. To credential network physicians
  2. To review the medical necessity and appropriateness of care before or after it is delivered Correct answer.
  3. To set actuarial premium rates
  4. To recruit new members through marketing

Explanation

Utilization management applies criteria to evaluate whether requested services are medically necessary and appropriate. Common tools include prior authorization and concurrent review.

Question 16Health Care Delivery Systems and Organization

A rural county has too few primary care physicians relative to its population. Which federal designation is designed to address this shortage?

  1. Health Professional Shortage Area Correct answer.
  2. Medically Underserved Area
  3. Federally Qualified Health Center
  4. Accountable Care Organization

Explanation

HPSA designation identifies areas with shortages of primary, dental, or mental health professionals and supports recruitment incentives such as loan repayment. MUA designation addresses broader underservice but HPSA is the workforce-specific tool.

Question 17Health Care Delivery Systems and Organization

Which statement accurately describes the Emergency Medical Treatment and Labor Act (EMTALA)?

  1. It guarantees payment for all emergency care provided to uninsured patients
  2. It permits transfer of unstable patients without any physician involvement
  3. It requires hospitals with emergency departments to screen and stabilize patients regardless of ability to pay Correct answer.
  4. It applies only to federally owned hospitals

Explanation

EMTALA imposes a screening and stabilization duty on Medicare-participating hospitals with emergency departments, independent of insurance status. Transfers of unstable patients require appropriate medical certification and stabilization within capability.

Question 18Health Care Delivery Systems and Organization

A state expands Medicaid eligibility under the Affordable Care Act. Which financing structure applies to the expansion population?

  1. Private insurer funding through premium taxes
  2. Enhanced federal matching that phases down to a standard match over time Correct answer.
  3. Block grants set by the state legislature
  4. Full state funding with no federal match

Explanation

The ACA provided enhanced federal matching for expansion populations, with the match rate stepping down over time to a higher-than-standard level. States retain some share of the cost thereafter.

Question 19Health Care Delivery Systems and Organization

Which of the following is the best example of a prospective payment system?

  1. Paying physicians a percentage of collected charges
  2. Paying a hospital a fixed amount per diagnosis-related group before care is delivered Correct answer.
  3. Paying a bonus based on patient satisfaction scores
  4. Reimbursing a hospital for actual costs after discharge

Explanation

Prospective payment sets a predetermined rate per case category, such as a DRG, before services are rendered, shifting utilization risk to the provider. Cost-based retrospective reimbursement works in the opposite direction.

Question 20Health Care Delivery Systems and Organization

A large employer self-funds its health plan but hires a company to process claims and manage the network. That company is best described as which of the following?

  1. A pharmacy benefit manager
  2. A third-party administrator Correct answer.
  3. A captive insurer
  4. A health maintenance organization

Explanation

A third-party administrator handles claims processing and network management for a self-funded plan without bearing insurance risk. The employer retains the financial risk.

Question 21Health Care Delivery Systems and Organization

Which of the following best describes the concept of a closed panel in managed care?

  1. Care is delivered by a defined group of contracted or employed physicians Correct answer.
  2. Enrollees pay no premiums and only copayments
  3. Enrollees may see any licensed provider in the state
  4. Providers are paid solely through retrospective cost reimbursement

Explanation

A closed panel restricts care to a defined set of physicians, often employed or exclusively contracted, which supports utilization control. Open panels allow broader provider choice.

Question 22Health Care Delivery Systems and Organization

A payer shifts from volume-based to value-based contracts. Which combination of measures would most directly align with that shift?

  1. Increased service volume and higher utilization targets
  2. Quality metrics plus total cost of care for an attributed population Correct answer.
  3. Higher fee schedule rates with no quality reporting
  4. Longer inpatient lengths of stay as a performance goal

Explanation

Value-based contracts tie payment to quality performance and total cost of care for a defined population, rewarding outcomes rather than volume. This structure shifts risk toward providers who manage utilization and quality.

Question 23Health Care Delivery Systems and Organization

In a risk-adjusted capitation arrangement, why does the plan adjust payments based on enrollee diagnoses?

  1. To reward providers for ordering more tests
  2. To eliminate the need for quality reporting
  3. To compensate providers for predictable differences in expected resource use across patient populations Correct answer.
  4. To ensure every provider receives an identical payment

Explanation

Risk adjustment accounts for differences in illness burden so providers caring for sicker panels are not unfairly penalized under capitation. It aims to make payments reflect expected resource needs.

Question 24Health Care Delivery Systems and Organization

Which of the following most accurately describes the relationship between Medicare Parts A and B and a Medicare Advantage plan?

  1. The MA plan receives a capitated payment and must provide at least the A and B benefit package Correct answer.
  2. The MA plan pays providers using unmodified fee-for-service rates set by CMS
  3. The MA plan may exclude hospital coverage to reduce premiums
  4. The MA plan replaces Medicare entirely and enrollees lose all Medicare rights

Explanation

CMS pays MA organizations a risk-adjusted capitated rate, and plans must deliver coverage at least equivalent to Parts A and B. Plans may add benefits and use their own network and payment arrangements.

Question 25Health Care Delivery Systems and Organization

A hospital and a physician group form a joint venture and structure it to fit within a Stark exception. Which factor is most essential for the arrangement to qualify?

  1. The venture must pay physicians based on the volume of referrals
  2. The arrangement must be documented in writing and reflect fair market value Correct answer.
  3. The hospital must guarantee a minimum referral volume
  4. The physicians must refer only to the joint venture

Explanation

Stark exceptions generally require written agreements, fair market value compensation, and no link between compensation and referral volume. These elements prevent the arrangement from rewarding referrals.

Question 26Health Care Delivery Systems and Organization

Which type of health care organization is owned and governed by its members and historically emerged to provide prepaid care to enrolled populations?

  1. A preferred provider organization
  2. A nonprofit community health center
  3. A staff-model health maintenance organization
  4. A health care cooperative Correct answer.

Explanation

Health care cooperatives are member-owned and member-governed entities in which enrollees hold voting control over the organization. This member ownership distinguishes them from investor-owned or employer-sponsored plans.

Question 27Health Care Delivery Systems and Organization

Which federal agency is responsible for administering the Medicare program at the national level?

  1. The Health Resources and Services Administration
  2. The Food and Drug Administration
  3. The Agency for Healthcare Research and Quality
  4. The Centers for Medicare & Medicaid Services Correct answer.

Explanation

The Centers for Medicare & Medicaid Services (CMS) is the federal agency within the Department of Health and Human Services that administers Medicare and also oversees Medicaid at the federal level. The other agencies have different public health and research missions.

Question 28Health Care Delivery Systems and Organization

A payer wants to measure how often its diabetic enrollees receive recommended retinal eye exams. Which of the following best describes the type of measure this represents?

  1. An outcome measure of disease control
  2. A structural measure of network capacity
  3. A cost-efficiency measure of resource use
  4. A process measure of care quality Correct answer.

Explanation

A process measure assesses whether a recommended service or intervention was delivered, such as a screening exam. Outcome measures capture health status results, while structural measures describe capacity and resources.

Question 29Health Care Delivery Systems and Organization

A health plan and a hospital negotiate a contract in which the hospital receives a fixed per-member-per-month payment to provide all inpatient care for the plan's enrollees. Which payment arrangement does this describe?

  1. A case rate payment arrangement
  2. A per diem payment arrangement
  3. A fee-for-service payment arrangement
  4. A capitation payment arrangement Correct answer.

Explanation

Capitation pays a fixed amount per enrollee per period regardless of how many services are used, shifting utilization risk to the provider. Per diem and case rates are tied to units of service or episodes rather than to enrolled members over time.

Question 30Health Care Delivery Systems and Organization

A state wants to move its Medicaid program to a model in which private plans receive a fixed monthly payment per enrollee and bear financial risk for the covered population. Which structural consideration most directly affects whether the state achieves budget predictability under this approach?

  1. Whether participating plans are accredited by a national accrediting body
  2. Whether enrollees are permitted to change plans during an open enrollment period
  3. Whether the state sets actuarially sound rates that reflect the health risk of enrollees Correct answer.
  4. Whether the plans are required to report HEDIS quality measures annually

Explanation

In Medicaid managed care, the state's budget predictability depends on setting actuarially sound capitation rates that accurately reflect the acuity and risk mix of the enrolled population. If rates are mispriced, plans may face losses, exit the market, or the state may face corrective rate adjustments. Quality reporting, accreditation, and enrollment flexibility are important but do not directly determine the fiscal predictability of the capitated arrangement.

Question 31Health Policy, Law, and Regulation

Under the federal Emergency Medical Treatment and Labor Act (EMTALA), a hospital with an emergency department must provide which of the following to any person who presents for emergency care, regardless of ability to pay?

  1. A referral to a primary care physician within 72 hours
  2. Free prescription medications for 30 days after discharge
  3. A medical screening examination and stabilizing treatment for an emergency medical condition Correct answer.
  4. A guarantee of inpatient admission for at least 24 hours

Explanation

EMTALA requires Medicare-participating hospitals with emergency departments to perform an appropriate medical screening examination and to stabilize an emergency medical condition before transfer or discharge, without regard to insurance or payment. It does not mandate admission, free medications, or outpatient referral timelines.

Question 32Health Policy, Law, and Regulation

A physician group wants to know which federal law primarily governs the privacy and security of protected health information held by covered entities. That law is:

  1. The Emergency Medical Treatment and Labor Act
  2. The Occupational Safety and Health Act
  3. The Clinical Laboratory Improvement Amendments
  4. The Health Insurance Portability and Accountability Act Correct answer.

Explanation

HIPAA, through its Privacy Rule and Security Rule, sets national standards for protecting individually identifiable health information held by covered entities and their business associates. CLIA governs laboratory testing, OSHA governs workplace safety, and EMTALA governs emergency care access.

Question 33Health Policy, Law, and Regulation

A patient with decision-making capacity refuses a recommended blood transfusion. The most appropriate administrative response is to:

  1. Honor the refusal after documenting informed consent discussion Correct answer.
  2. Obtain a court order authorizing treatment over the refusal
  3. Administer the transfusion because it is life-sustaining
  4. Transfer the patient to another facility that will transfuse

Explanation

A competent adult has the legal right to refuse medical treatment, including life-sustaining treatment, based on informed consent and bodily autonomy doctrines. The clinician should document the discussion and the patient's decision. Overriding a capacitated refusal requires exceptional legal grounds not present here.

Question 34Health Policy, Law, and Regulation

Which of the following best describes the purpose of the Medicare Conditions of Participation?

  1. They set minimum health and safety standards that hospitals must meet to participate in Medicare Correct answer.
  2. They determine malpractice liability standards for participating providers
  3. They define eligibility criteria for Medicare beneficiaries
  4. They establish physician fee schedules for Medicare reimbursement

Explanation

Conditions of Participation are regulatory requirements that providers must satisfy to be eligible for Medicare payment, focusing on patient health and safety, quality, and organizational governance. Fee schedules, malpractice standards, and beneficiary eligibility are governed by other mechanisms.

Question 35Health Policy, Law, and Regulation

A hospital's peer review committee is evaluating a physician's clinical performance. Which legal protection is most commonly invoked to shield peer review deliberations from discovery in litigation?

  1. The False Claims Act public disclosure bar
  2. The doctrine of respondeat superior
  3. The Health Care Quality Improvement Act immunity provisions Correct answer.
  4. The Stark Law self-referral exceptions

Explanation

The Health Care Quality Improvement Act provides limited immunity from damages for peer review participants acting in good faith and following required procedural safeguards, and many states add peer review privilege statutes. Respondeat superior, Stark, and the FCA address different legal issues.

Question 36Health Policy, Law, and Regulation

Under the Anti-Kickback Statute, which arrangement is most likely to be lawful?

  1. A lab paying physicians a per-test fee for each referral
  2. A hospital giving free office space to referring physicians
  3. A medical director stipend that is fair market value and documented for actual services Correct answer.
  4. Waiving a referring physician's copay in exchange for referrals

Explanation

The Anti-Kickback Statute prohibits remuneration intended to induce referrals of federally payable items or services, but a fair market value stipend for bona fide services under a written agreement fits within a safe harbor. Per-referral payments, free rent, and copay waivers tied to referrals raise clear inducement concerns.

Question 37Health Policy, Law, and Regulation

The Stark Law primarily prohibits which of the following?

  1. Paying employees below the prevailing wage
  2. Sharing patient records with business associates without a contract
  3. Physician referrals of designated health services to entities with which the physician has a financial relationship, absent an exception Correct answer.
  4. Billing Medicare for services that are not medically necessary

Explanation

The Stark Law (Physician Self-Referral Law) bars physicians from referring Medicare-designated health services to entities in which they or immediate family members have a financial relationship unless a regulatory exception applies. Medical necessity, wage rules, and business associate contracts are governed elsewhere.

Question 38Health Policy, Law, and Regulation

A hospital discovers a breach of unsecured protected health information affecting 800 individuals in one state. Under HIPAA, which action is required?

  1. Notify only the affected individuals within 30 days
  2. Notify affected individuals, the HHS Secretary, and prominent media outlets without unreasonable delay and no later than 60 days after discovery Correct answer.
  3. Post a notice on the hospital website in lieu of individual notification
  4. Notify the state medical board within 10 days

Explanation

For breaches affecting 500 or more residents of a state or jurisdiction, HIPAA requires notification to affected individuals, HHS, and prominent media outlets without unreasonable delay and no later than 60 days after discovery. Website posting alone is insufficient.

Question 39Health Policy, Law, and Regulation

The primary purpose of a Certificate of Need (CON) program is to:

  1. Authorize hospitals to bill Medicaid for inpatient care
  2. Regulate capital expenditures for certain health facility services to control costs and avoid duplication Correct answer.
  3. Verify that hospitals meet Medicare Conditions of Participation
  4. Certify physicians' clinical competence for licensure

Explanation

CON laws require providers to obtain state approval before establishing or expanding certain services or capital projects, aiming to align capacity with community need and control costs. They do not license physicians, substitute for Medicare certification, or authorize Medicaid billing.

Question 40Health Policy, Law, and Regulation

Which entity is responsible for maintaining the National Practitioner Data Bank?

  1. The Health Resources and Services Administration Correct answer.
  2. The Food and Drug Administration
  3. The Federal Trade Commission
  4. The Drug Enforcement Administration

Explanation

The NPDB is administered by the Health Resources and Services Administration within HHS and collects reports on malpractice payments and adverse actions against practitioners. The FDA, FTC, and DEA have unrelated regulatory missions.

Question 41Health Policy, Law, and Regulation

A state legislature wants to expand the scope of practice for nurse practitioners to include independent prescribing. Which body has the primary authority to make this change?

  1. The hospital medical staff executive committee
  2. The federal Centers for Medicare & Medicaid Services
  3. The Joint Commission
  4. The state legislature through statute or delegation to the board of nursing Correct answer.

Explanation

Scope of practice is governed by state law, typically through statutes and regulations adopted by state licensing boards such as the board of nursing. Federal agencies, accreditors, and hospital committees do not set the statutory scope of practice for a profession.

Question 42Health Policy, Law, and Regulation

Under the doctrine of corporate negligence, a hospital may be held liable when it:

  1. Declines to admit a patient who lacks insurance
  2. Fails to exercise reasonable care in selecting, credentialing, or supervising its medical staff Correct answer.
  3. Provides charitable care to indigent patients
  4. Employs a physician who commits malpractice outside the hospital

Explanation

Corporate negligence, also called corporate liability, holds a hospital directly liable for breaching its own duties to patients, such as reasonable care in credentialing, privileging, and overseeing staff and facilities. Vicarious liability for employee acts is a distinct theory.

Question 43Health Policy, Law, and Regulation

The Medicare physician fee schedule is updated annually through which regulatory process?

  1. Congressional appropriation only
  2. Notice-and-comment rulemaking by CMS Correct answer.
  3. Executive order of the President
  4. Direct negotiation between hospitals and insurers

Explanation

CMS updates the physician fee schedule through the administrative rulemaking process, publishing proposed and final rules with a public comment period. Congress sets some payment parameters by statute, but the schedule itself is updated by regulation.

Question 44Health Policy, Law, and Regulation

Which of the following is a core requirement of the HIPAA Privacy Rule's minimum necessary standard?

  1. Covered entities must disclose all records requested by any licensed clinician
  2. Business associates must be granted unrestricted access to patient records
  3. Covered entities must make reasonable efforts to limit uses and disclosures of protected health information to the minimum necessary for the purpose Correct answer.
  4. Patients must obtain employer approval before accessing their records

Explanation

The minimum necessary standard requires covered entities to make reasonable efforts to limit protected health information used, disclosed, or requested to the least amount needed to accomplish the intended purpose, with exceptions such as treatment disclosures. It does not require or permit unrestricted access.

Question 45Health Policy, Law, and Regulation

A physician receives a subpoena for a patient's medical records in a malpractice case. The most appropriate initial step is to:

  1. Release the record only after the patient pays outstanding bills
  2. Immediately release the complete record to the requesting attorney
  3. Refuse all subpoenas as a matter of policy
  4. Verify the subpoena's validity and confirm that patient authorization or a court order satisfies legal requirements before disclosure Correct answer.

Explanation

Before disclosing protected health information in response to a subpoena, a provider must confirm that the request is legally sufficient and that HIPAA requirements, such as a valid authorization or satisfactory assurances through a court order or qualified protective order, are met. Immediate release or blanket refusal is inappropriate.

Question 46Health Policy, Law, and Regulation

The False Claims Act imposes liability primarily on parties that:

  1. Charge patients more than the Medicare fee schedule
  2. Fail to maintain accreditation with a private body
  3. Submit or cause the submission of false or fraudulent claims to the federal government Correct answer.
  4. Employ physicians without hospital privileges

Explanation

The False Claims Act prohibits knowingly presenting, or causing to be presented, false or fraudulent claims for payment to the federal government and provides for treble damages and civil penalties. It does not regulate accreditation status, charge caps, or privileging.

Question 47Health Policy, Law, and Regulation

Which of the following best describes the legal significance of a hospital's medical staff bylaws?

  1. They set the hospital's Medicare reimbursement rates
  2. They form a contract-like framework governing appointment, privileging, and discipline of medical staff members Correct answer.
  3. They replace state licensure requirements for physicians
  4. They are advisory documents with no enforceable effect

Explanation

Medical staff bylaws establish binding governance for staff membership and privileges and are generally treated as enforceable, contract-like obligations between the hospital and its medical staff. They do not supersede licensure or set payment rates.

Question 48Health Policy, Law, and Regulation

A patient is injured by a defective medical device. Under product liability law, the manufacturer may be held liable under which theory even without proof of negligence?

  1. Breach of fiduciary duty
  2. Strict liability for a defective product Correct answer.
  3. Res ipsa loquitur
  4. Intentional infliction of emotional distress

Explanation

Strict product liability allows recovery for injuries caused by defective products without proof that the manufacturer was negligent, focusing on the condition of the product. Res ipsa loquitur is an evidentiary inference, and fiduciary duty and intentional torts address different relationships and conduct.

Question 49Health Policy, Law, and Regulation

Which federal agency has primary responsibility for approving new prescription drugs for marketing in the United States?

  1. The Centers for Disease Control and Prevention
  2. The Agency for Healthcare Research and Quality
  3. The Food and Drug Administration Correct answer.
  4. The National Institutes of Health

Explanation

The FDA reviews and approves new drug applications and oversees drug labeling and safety. The CDC focuses on public health surveillance, NIH on research, and AHRQ on health services research.

Question 50Health Policy, Law, and Regulation

A physician wants to prescribe a controlled substance for a patient with chronic pain. Which requirement is most directly imposed by the Controlled Substances Act?

  1. Registration with the DEA to dispense controlled substances Correct answer.
  2. Approval by the hospital pharmacy and therapeutics committee
  3. Certification by the American Board of Internal Medicine
  4. Membership in the state medical society

Explanation

The Controlled Substances Act requires practitioners who dispense controlled substances to register with the DEA and comply with corresponding state requirements. Board certification, society membership, and P&T approval are not federal statutory prerequisites.