Pharmacy Practice Chapter 6 Quiz
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Questions and Answers

What is the maximum penalty for a violation of the Anti-Kickback Statute (AKS)?

  • 5 years imprisonment and a $25,000 fine (correct)
  • 10 years imprisonment and a $50,000 fine
  • 1 year imprisonment and a $30,000 fine
  • 3 years imprisonment and a $15,000 fine

    • Which of the following activities could potentially violate the Anti-Kickback Statute?

  • Offering free consultations to patients
  • Providing educational grants to healthcare providers (correct)
  • Running a drug discount program
  • Accepting donations from patients for services

    • What does the Stark law primarily prohibit?

  • Patients from self-referring to specialists
  • Pharmacies from accepting kickbacks from drug manufacturers
  • Doctors from promoting off-label drugs
  • Healthcare providers from referring patients if they have a financial relationship (correct)

    • Is intent required to prove a Stark law violation?

    <p>No, intent is not required for proving a violation</p> Signup and view all the answers

    Which statement about Long-Term Care Facilities (LTCFs) and psychotropic medications is true?

    <p>Gradual dose reductions are required for improperly prescribed psychotropic medications</p> Signup and view all the answers

    What is the primary objective of the regulations surrounding medication management in LTCFs?

    <p>To ensure drug therapy is free from unnecessary medications</p> Signup and view all the answers

    Which of the following statements regarding medication dispensing in LTCFs is accurate?

    <p>CMS limits dispensing to a maximum of a 14-day cycle</p> Signup and view all the answers

    Which scenario is an example of a medication error that might be addressed under regulatory guidelines?

    <p>Dispensing a duplicated therapy without monitoring</p> Signup and view all the answers

    Which of the following is a potential violation of the False Claims Act related to pharmacy practice?

    <p>Submitting false information to obtain higher reimbursement rates</p> Signup and view all the answers

    What does the Anti-Kickback Statute aim to prevent within pharmacy practice?

    <p>Pharmacies paying for patient referrals or incentives</p> Signup and view all the answers

    Under what conditions might a pharmacy be in violation of Stark Law?

    <p>Entering agreements for services with a physician with whom they have a financial relationship</p> Signup and view all the answers

    Which of the following best describes a medication error management protocol in pharmacy practice?

    <p>Implementing a systematic process for identifying and preventing medication errors</p> Signup and view all the answers

    Which regulation requires pharmacies providing services to Long-Term Care Facilities to comply with specific requirements?

    <p>CMS guidelines for Long-Term Care Facilities</p> Signup and view all the answers

    What is a significant requirement under Medicaid prescription pad regulations?

    <p>Prescription pads must have tamper-resistant features</p> Signup and view all the answers

    Which of the following actions could be considered a violation of Medication Therapy Management (MTM) guidelines?

    <p>Conducting medication reviews without patient interaction</p> Signup and view all the answers

    How does the Sherman Antitrust Act relate to pharmacy practice?

    <p>It governs mergers and acquisitions among pharmacies to promote competition</p> Signup and view all the answers

    Which of the following statements about the reimbursement for pharmacies under Medicare Part D is true?

    <p>Pharmacies receive an ingredient cost reimbursement plus a dispensing fee per the plan's determination.</p> Signup and view all the answers

    Under the False Claims Act, which of the following is required for plans and pharmacies?

    <p>They must have policies to address fraud, waste, and abuse.</p> Signup and view all the answers

    Which scenario reflects a violation of the Anti-Kickback Statute?

    <p>A pharmacy offers cash incentives to healthcare providers for prescribing certain medications.</p> Signup and view all the answers

    What is a requirement for a pharmacy that supplies Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)?

    <p>The pharmacy must be accredited unless certain criteria are met.</p> Signup and view all the answers

    What is the purpose of the Medication Therapy Management (MTM) programs required by law?

    <p>To improve patient medication adherence and health outcomes for chronic conditions.</p> Signup and view all the answers

    Which statement accurately describes the current status of pharmacists under Medicare?

    <p>Pharmacists are not recognized as providers under Medicare, affecting their compensation.</p> Signup and view all the answers

    What does the Federal Upper Limit (FUL) program establish?

    <p>The reimbursement amount for specified multiple source drugs.</p> Signup and view all the answers

    Which of the following chronic conditions is NOT one of the core nine conditions targeted for MTM services?

    <p>Obesity</p> Signup and view all the answers

    Which part of Medicare primarily covers prescription drug benefits?

    <p>Part D</p> Signup and view all the answers

    What key feature must Medicare Part D plans provide regarding pharmacy access?

    <p>Access to a network of pharmacies</p> Signup and view all the answers

    Which law addresses the submission of false claims to government healthcare programs?

    <p>False Claims Act</p> Signup and view all the answers

    In Medicaid, what is the requirement for prescription pads to ensure compliance?

    <p>Tamper-resistant prescription pads</p> Signup and view all the answers

    Which provision prohibits physician referrals to entities in which they have a financial interest?

    <p>Stark Law</p> Signup and view all the answers

    What does the Anti-Kickback Statute primarily aim to prevent?

    <p>Inducements for referrals to federally funded healthcare programs</p> Signup and view all the answers

    Who administers Medicaid, and how is it funded?

    <p>States, with shared funding and federal oversight</p> Signup and view all the answers

    What does the Sherman Antitrust Act aim to ensure in pharmacy practices?

    <p>Fair competition and prevention of monopolistic practices</p> Signup and view all the answers

    Which group cannot access Medicare benefits based solely on age?

    <p>Individuals under 65 with certain disabilities</p> Signup and view all the answers

    What is a requirement for pharmacy plans under Medicare Part D?

    <p>Offering Medication Therapy Management (MTM) for chronic conditions</p> Signup and view all the answers

    What defines the eligibility criteria for Medicaid?

    <p>Income level determined by federal guidelines</p> Signup and view all the answers

    What is one major focus of the Stark Law in terms of healthcare practices?

    <p>Completely banning self-referral for designated services</p> Signup and view all the answers

    Which act includes penalties such as treble damages for submitting false claims?

    <p>False Claims Act (FCA)</p> Signup and view all the answers

    What aspect of pharmacy operations is directly addressed by the Anti-Kickback Statute?

    <p>Provision of kickbacks for legitimate referrals</p> Signup and view all the answers

    Which of these statements regarding the Sherman Antitrust Act is true?

    <p>Section 1 prohibits agreements that restrain trade</p> Signup and view all the answers

    Which of the following best describes the funding structure of Medicaid?

    <p>Jointly funded by state and federal governments</p> Signup and view all the answers

    Study Notes

    Federal Regulation of Pharmacy Practice

    • Required reading: Pharmacy Practice and the Law, 10th Ed.
    • Chapter 6: Federal Regulation of Pharmacy Practice (pp. 275-285, 289-294, 300-309)
    • Additional material from pp. 275-312 will be covered in class.
    • Excluded pages won't be on the RAT (Review Assessment Tool).

    Overview

    Class Format

    • 10-question iRAT/tRAT (in-class assessment)
    • Application exercises following the tRAT

    Learning Objectives (Book Objectives):

    • Basic drug and pharmacy provisions of Medicare and Medicaid
    • Medicare/Medicaid fraud and abuse laws
    • CMS requirements for long-term care facilities (LTCFs)
    • Sherman Antitrust Act application to pharmacy practice
    • Robinson-Patman Act application to pharmacy practice

    Additional Targeted Objectives (for RAT):

    • Four groups covered by Medicare
    • Medicare Part D:
      • Enrollment periods
      • Pharmacy access
      • Notice required when claims aren't covered
      • Medication therapy management (MTM) requirements

    Other Topics (Page 2):

    • Fraud and abuse implications for pharmacies/pharmacists
    • Medicaid eligibility requirements & funding
    • Prescription drug coverage under Medicaid
    • Prescription pad requirements
    • False Claims Act violations
    • Anti-Kickback Statute and Stark Law violations
    • Sherman Antitrust Act (application; Sections 1 and 2)
    • Robinson-Patman Act (application; own use doctrine)

    Selected Book Take-Away Points (Page 2):

    • Medicare Parts A, B, C (Advantage), and D
    • Prescription drug benefits (part D)
    • Open enrollment periods
    • Formularies (must include 2 drugs in each therapeutic category/class)
    • Mail-order pharmacies vs community pharmacies
    • Preferred pharmacy networks

    Pharmacy Reimbursement and Regulations (Page 3):

    • Ingredient cost + dispensing fee reimbursement
    • Claim payment deadlines
    • Printed notices for non-covered prescriptions
    • Medication Therapy Management (MTM) programs
    • Fraud, waste, and abuse policies and procedures
    • Pharmacy employee training programs
    • DMEPOS accreditation exemptions
    • Pharmacist provider status under Medicare (APHA's ongoing support for federal legislation change)

    Medicaid Administration and Federal Regulations (Page 3):

    • Administration by the states
    • Joint federal/state funding
    • Federal approval and regulation
    • MAC (Managed Care) and FUL pricing programs
    • Medicaid drug reimbursement calculation
    • "Retail Community Pharmacy" definition exclusions
    • Average Price Measures (AMP)
    • Calculation of the FUL price

    Additional Regulations (Pages 4 and 5):

    • Pharmacy reimbursement from Medicare Part D
    • False Claims Act (FCA) violations
    • Anti-Kickback Statute (AKS) violations
    • Stark Law prohibitions
    • Requirements for long-term care facilities (LTCFs) (drug dispensing and storage, clinical appropriateness of medications, psychotropic medication limits, medication error rates)
    • Consultations with pharmacists in LTCFs
    • Sherman Antitrust Act (monopoly analysis, rule of reason, per se rule, activities like price-fixing, boycotting, tying arrangements)
    • Pharmacy benefit managers (PBMs)
    • Purchasing cooperatives and competitive pro-active activities
    • 340B drug pricing regulations.
    • Patient Safety and Quality Act (PSQIA)
    • Patient safety events reporting and privacy

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    2024 Pharmacy Law - Week 12 PDF

    Description

    Test your knowledge on Federal Regulation of Pharmacy Practice based on Chapter 6 of 'Pharmacy Practice and the Law'. This quiz covers key provisions related to Medicare and Medicaid, as well as important laws impacting pharmacy practice. Perfect for understanding the regulatory landscape in the pharmacy field.

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