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 (C)</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 (C)</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 (A)</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 (B)</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 (C)</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 (C)</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 (D)</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 (A)</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 (A)</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 (B)</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 (D)</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 (A)</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 (A)</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. (D)</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. (D)</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. (D)</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. (C)</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. (B)</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. (B)</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. (B)</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 (A)</p> Signup and view all the answers

Which part of Medicare primarily covers prescription drug benefits?

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

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

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

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

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

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

<p>Stark Law (D)</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 (B)</p> Signup and view all the answers

Who administers Medicaid, and how is it funded?

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

Which group cannot access Medicare benefits based solely on age?

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

What defines the eligibility criteria for Medicaid?

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

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

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

Flashcards

Medicare Part D Enrollment Periods

Specific timeframes for Medicare beneficiaries to enroll in Part D prescription drug coverage.

Medicare Part D Pharmacy Access

Guidelines in place for beneficiaries to have access to participating pharmacies for prescription filling and coverage.

Medicaid Eligibility

Criteria that determines if a person or group is eligible to receive benefits under the Medicaid program.

Medicare/Medicaid Fraud and Abuse Laws

Legal regulations intended to prevent and address fraud activities related to receiving benefits under Medicare and Medicaid.

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False Claims Act

Federal law that addresses and prosecutes fraudulent claims made to obtain Medicare and Medicaid funds.

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Anti-Kickback Statute

Federal law that prohibits offering, paying, soliciting, or receiving remuneration to influence referrals for Medicare or Medicaid services.

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Medication Therapy Management (MTM)

Services provided by qualified professionals to improve the effectiveness and safety of prescriptions, especially regarding prescription drug costs.

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4 Groups Covered by Medicare

Specific groupings of people (e.g., the elderly) who often qualify.

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Beneficiary Drug Supply

Beneficiaries receive the same drugs at any community or mail-order pharmacy.

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Pharmacy Networks

Many insurance plans use preferred pharmacy networks, and some exclude pharmacies.

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Pharmacy Reimbursement

Pharmacies paid ingredient cost plus dispensing fee, with claims paid within 14 days.

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Medication Non-Coverage Notice

Pharmacies must give patients a printed notice if a prescription isn't covered.

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MTM Programs

Plans must offer Medication Therapy Management (MTM) programs, and pharmacists can get paid for these services.

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MTM Qualification

Beneficiaries only require 3 chronic diseases to qualify for MTM; the plan must offer MTM for at least 5 of 9 chronic conditions.

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Fraud and Abuse Prevention

Part D plans and pharmacies must address fraud, waste, and abuse; policies and training are required.

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DMEPOS Accreditation

Pharmacies supplying Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) must be accredited, but there are exceptions.

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AKS

The Anti-Kickback Statute; prohibits knowingly soliciting, receiving, offering, or paying remuneration for referrals or goods/services paid for by Medicare/Medicaid.

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Stark Law

Prohibits certain healthcare providers from referring Medicare/Medicaid patients to entities where the provider or family member has financial ties.

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LTCF

Long-Term Care Facilities. Federal rules impact drug storage, administration, and dispensing in LTCFs.

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Drug Manufacturer Programs (Violating AKS)

Programs that give incentives to providers for using their products may violate AKS. (e.g. educational grants, research funding, gifts, drug switching fees).

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Self-Administered Medications

Residents in LTCFs may self-administer medications if the interdisciplinary team approves it.

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Unnecessary Medications

Excessive doses, duration, or lack of monitoring, and/or adverse consequences, are considered unnecessary medications, hence these should be avoided

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Psychotropic Medications (LTCF)

Use of psychotropic medications in LTCFs is limited to documented diagnoses and gradually reduced/discontinued when not medically needed. PRN orders are limited to 14 days.

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14-Day Medication Cycle (LTCF)

Pharmacies servicing LTCFs are limited to dispensing medications for a maximum of 14 days at a time.

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Medicare Part A

Medicare part covering hospitalizations.

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Medicare Part B

Medicare part covering certain outpatient services.

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Medicare Part C

Medicare part offering managed care options.

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Medicare Part D

Medicare part providing prescription drug benefits.

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Medicare enrollment period

Specific timeframes for Medicare beneficiaries to enroll.

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False Claims Act (FCA)

Prohibits submitting false claims to government programs.

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Anti-Kickback Statute (AKS)

Prohibits inducements for referrals for covered services.

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Medicaid eligibility

Criteria for receiving Medicaid benefits based on income.

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Medicare Eligibility Groups

Medicare covers individuals aged 65+, those under 65 with disabilities, those with End-Stage Renal Disease (ESRD), and Amyotrophic Lateral Sclerosis (ALS).

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Medicare Part D Enrollment

Annual open enrollment from October 15 to December 7 for Medicare Part D plans.

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Medicaid Eligibility

Medicaid covers low-income individuals, families, children, pregnant women, and individuals with disabilities; eligibility is set by states based on federal guidelines.

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False Claims Act (FCA)

Federal law prohibiting knowingly submitting false claims for federal programs; penalties for violation include fines and treble damages.

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Anti-Kickback Statute (AKS)

Prohibits offering or accepting remuneration (payment) for referrals in federal programs like Medicare/Medicaid; safe harbors exist for discounts and personal service agreements.

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Robinson-Patman Act

Prevents price discrimination among buyers in competitive markets; exempts nonprofits using the "own use" doctrine.

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Sherman Antitrust Act

Prohibits agreements that restrain trade (e.g., price fixing) and monopolization or attempts to monopolize markets under Sections 1 and 2, respectively.

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Medication Therapy Management (MTM) for Part D

Medicare Part D plans must offer medication therapy management (MTM) for enrollees with multiple chronic conditions.

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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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