Accreditation program (ASM)

    
    

Marketing and Sales in the Biopharmaceutical Industry

Introduction: This module explores the marketing life cycle of a drug, looks at the role of marketing research in the biopharmaceutical industry, and describes the factors that can impact product pricing. It also discusses how product sales are tracked, describes common promotional strategies, and explains the role and responsibilities of national account managers.

Objectives:

1.	Describe the phases of the marketing life cycle of a drug product, particularly in terms of acceptance and sales.
2.	Explain the ways in which marketing research is used in the biopharmaceutical industry.
3.	Explain the supply, demand, value, and environmental factors that affect the pricing of biopharmaceutical drug products and their impact on patients.
4.	Explain how prescribing information is tracked by data monitoring systems.
5.	Describe product promotion strategies used by biopharmaceutical companies and restrictions on their use.
6.	Identify value-added services provided by biopharmaceutical companies.
7.	Explain the roles and the responsibilities of the national account management team.


    
    

Challenges Facing the Biopharmaceutical Industry

Introduction: This module discusses products, programs, and technologies that are in place to address the challenges presented by managed care attempts to address healthcare costs, globalization, and the growing problem of counterfeit biopharmaceuticals. These areas have all been targeted as significant and growing challenges to the biopharmaceutical industry today.

Objectives:

1.	Characterize the effect of managed care and the drive for value on the biopharmaceutical industry.
2.	Understand how government regulations and support of health information technology are being used to improve healthcare quality.
3.	List major factors related to globalization that have influenced the biopharmaceutical industry.
4.	Describe the threats posed by drug counterfeiting and steps the industry has taken to control it.
5.	Understand the continued popularity of pharmacy compounding and recent events.


    
    

Recent Legislation Impacting the Biopharmaceutical Industry

Introduction: This module discusses key laws and also provides an overview on the FDA OTC Drug Review and controls that have been implemented by the biopharmaceutical industry.

Objectives:

1.	Describe the Medicare Modernization Act of 2003 and its effect on the biopharmaceutical industry.
2.	Describe key provisions of the FDA Amendments Act of 2007 and its effects on the biopharmaceutical industry.
3.	Explain the implications of the Affordable Care Act of 2010 and other recent regulation to the biopharmaceutical industry.
4.	Describe the FDA’s OTC Drug Review of 1972 and its impact on the biopharmaceutical industry and recent legislation to regulate OTC drugs.
5.	Explain the source and content of voluntary controls within the biopharmaceutical industry.


    
    

Business Trends within the Biopharmaceutical Industry

Introduction: This module discusses business trends in the biopharmaceutical industry including, alliances and partnerships, management trends, regional business units, and the growing use of complementary and alternative medicines.

Objectives:

1.	Identify the types of alliances and partnerships occurring in the biopharmaceutical industry and explain the reasons for their implementation.
2.	Identify the management trends being implemented in many biopharmaceutical companies.
3.	Explain the growing popularity of regional business units (RBUs) in the biopharmaceutical industry.
4.	Explain the biopharmaceutical industry's interest in complementary and alternative medicine (CAM).


    
    

Skills for Navigating the Healthcare Industry in the 21st Century

Introduction: This module discusses some of the skills that healthcare sales professionals will require to grow and succeed in their territories and within their organizations. These skills include awareness of industry trends, an emphasis on customer service, effective partnering skills, negotiating skills, the ability to work as part of a team, knowledge of financial issues and strategic business planning, and technology skills.

Objectives:

1.	Describe the skills needed by a healthcare sales professional to build long-term customer relationships.
2.	Describe how a team approach to sales can create effective partnerships.


    
    

Alternative Healthcare Settings

Introduction: The emphasis on containing healthcare costs by reducing the length of hospital stays helped fuel the growth in alternative care settings. Such settings are important components of the continuum of care and are the focus of this module. They include long-term care facilities, hospice care, and ambulatory/outpatient settings.

Objectives:

1.	Describe the range of long-term care facilities available and the care they provide.
2.	Characterize palliative and hospice care, including the settings in which this type of care may be provided.
3.	Identify the services provided in ambulatory/outpatient settings, including home healthcare.


    
    

Hospitals--Accreditation, Types, and Key Personnel

Introduction: This module discusses hospital accreditation and describes the different types of hospitals within the healthcare community. It discusses key hospital personnel and highlights current trends in the hospital environment.

Objectives:

1.	Describe the role of the Joint Commission in hospital accreditation.
2.	Describe various attributes used to distinguish hospitals by their type.
3.	Explain the major functions and privileges of key hospital personnel.
4.	Describe current trends in the hospital environment.


    
    

Patient-Centered Care

Introduction: This module discusses the following topics: the patient's voice, a continuum of care, technologies that support patient-centered care, and measures of quality improvement in patient-centered care.

Objectives:

1.	Describe the areas in the healthcare industry that patients are influencing.
2.	Describe the components of a continuum of care.
3.	Identify some of the technologies used to support patient-centered care.
4.	Describe the potential consequences of poor health literacy.


    
    

Conducting Team Meetings and Managing Conflict

Introduction: This module focuses on how to plan for, run, and follow up a team meeting, as well as what causes conflicts among team members and how to resolve them.

Objectives:

1. Describe effective managerial skills for planning, conducting, and following up on team meetings.
2. Describe strategies for resolving or managing conflict between team members.


    
    

Appraising Employee Performance

Introduction: This module describes how to effectively appraise employee performance for the overall purpose of improving productivity. It addresses evaluating performance on an ongoing basis as well as conducting formal periodic reviews.

Objectives:

1. Describe methods for evaluating employee performance on an ongoing basis. 
2. List reasons for conducting a formal periodic review and identify commonly used performance appraisal systems. 
3. Explain the features of a hybrid performance appraisal system. 
4. Describe methods effective managers use to provide both positive and negative feedback, document behaviors, and keep records.


    
    

Coaching Employees

Introduction: This module describes the following elements involved in effective employee coaching: providing direction for employee development, providing employee support, giving and receiving feedback, listening effectively, and communicating on a personal level.

Objectives:

1. Describe how coaching can be used to provide direction to employees.
2. Compare and contrast the three types of support managers can provide to their employees through coaching.
3. Identify how effective managers give and receive feedback while coaching.
4. Describe effective listening traits of good coaches.
5. Identify communication skills that great coaches display and their benefits.


    
    

Communicating Within Teams

Introduction: This module describes various communication methods of communication from the more traditional memos and progress reports to contemporary methods that make communication with geographically dispersed members or virtual teams possible. These include e-mail, teleconferencing, videoconferencing, web conferencing, computerized discussion groups and online meetings, groupware, and other types of collaborative software.

Objectives:

1.	Describe how various communication methods can be used for effective communication within teams.


    
    

Developing Work Teams

Introduction: This module describes how to develop teams by understanding and applying the Tuckman model, which describes the stages of team evolution. Then, it explains how to successfully manage virtual teams. It also explains how to assign project responsibilities throughout the stages of team development and concludes by describing how team leaders and members can make effective decisions.

Objectives:

1. Describe the stages of team development outlined in the Tuckman model.
2. Describe how effective managers apply the Tuckman model to build and move their teams toward working efficiently and productively to reach their goals.
3. Describe the unique challenges and interventions associated with the successful management of virtual teams.
4. Summarize how project responsibilities are assigned to members throughout the stages of team development.
5. Describe common decision-making mistakes and the steps to sound decision making by teams and managers.


    
    

Hiring the Right Applicant

Introduction: This module describes the manager's role in developing an applicant pool by defining the open position and recruiting candidates. It also addresses some common interview problems and describes how to effectively prepare for, conduct, and gather information during interviews. The module concludes by describing how to evaluate information obtained during interviews and discussing legal considerations related to making a hiring decision.

Objectives:

1. Describe the process used by a hiring manager to effectively define an open position. 
2. Identify several methods for recruiting candidates. 
3. Describe common interview problems. 
4. Explain how a manager effectively prepares for, conducts, and gathers information during interviews. 
5. Describe how a manager effectively evaluates information obtained during interviews. 
6. Describe the laws regarding hiring practices that managers need to consider before offering a candidate a job.


    
    

Managing and Advocating Change in the Workplace

Introduction: This module describes several models that can be useful for understanding and managing change. It also explores strategies for championing change within an organization.

Objectives:

1. Describe common models for understanding and managing change.
2. Identify ways in which managers can effectively advocate change within their organizations.


    
    

Managing Diversity in the Workforce

Introduction: This module describes three paradigms--the discrimination-and-fairness paradigm, the access-and-legitimacy paradigm, and the emerging paradigm, which connects diversity to work perspectives. It concludes with additional suggestions for managing cultural diversity and tips for managing employees of different age groups.

Objectives:

1. Describe three paradigms for managing diversity.
2. Describe the conditions necessary for shifting from the discrimination-and-fairness paradigm or the access-and-legitimacy paradigm to an all-encompassing view.
3. Identify ways to successfully manage cultural diversity.
4. Describe effective management and communication techniques to use with employees in diverse age groups.


    
    

Motivating Employees

Introduction: This module describes how to identify what motivates individual employees and how different motivational tools can be used to maximize performance. It also lists some employee issues that necessitate counseling and explains the counseling skills required.

Objectives:

1. Compare and contrast various motivational tools that managers can use with employees.
2. Describe counseling skills managers can use to help employees who have issues that interfere with their work.


    
    

Setting Employee Goals and Objectives

Introduction: This module focuses on setting goals and objectives with employees to obtain better performance results. Specifically, it describes how to write appropriate goals and objectives, how to translate objectives into action plans that contain specific milestones, and how to periodically assess progress made.

Objectives:

1. Describe the elements that constitute an appropriate employee objective. 
2. Describe how an objective is translated into an effective action plan. 
3. Explain how effective managers assess progress made toward achieving objectives.


    
    

Supervising Employees

Introduction: This module describes how to effectively supervise employees by giving assignments and delegating tasks; setting goals, standards, and expectations; adopting the appropriate leadership style for the situation; monitoring progress; reviewing completed work and providing feedback; and making decisions that solve problems.

Objectives:

1. Describe the components of effective supervision.


    
    

Inside the C-Suite: Getting a Seat at the Table

Introduction: In integrated care organizations, decisions made in the C-Suite are applied across the care continuum. As these organizations are becoming central to our healthcare system, you are being asked increasingly to demonstrate your company's strategic value to their C-Suites. This module explains how integrated care organizations are reshaping the way life science sales teams conduct business. Then it describes a sales process that will help you succeed in the C-Suite environment.

Objectives:

1.	Describe how life science sales presentations to the C-Suite of integrated care organizations differ from calls on clinicians or P&T Committees.
2.	Outline the general account management process for establishing strategic partnerships within C-Suite organizations.
3.	Describe the purpose of and tasks involved in each step of the C-Suite sales process.


    
    

Inside the C-Suite: the Lay of the Land

Introduction: This module provides the foundation you need to succeed in the C-Suite environment. It examines the types of healthcare organizations that comprise a C-Suite target audience and identifies the key goals they share. It also profiles the C-Suite occupants and discusses how their individual goals connect with those of their organization.

Objectives:

1.	Describe the growth of IDNs and ACOs and the events and forces that have shaped decision-making in these integrated care organizations.
2.	Explain how integrated care organizations’ commitment to the Triple Aim can redefine value propositions.
3.	List the titles and roles of today’s C-Suite occupants and explain how their individual goals relate to their organizations’ larger concerns.


    
    

Impact of Pharmacoeconomics on the Formulary

Introduction: This module provides an overview of the P&T Committee: who its members are, what general guidelines the committee considers when planning a pharmacoeconomic study or evaluating an existing study, and how pharmaceutical sales professionals can best present pharmacoeconomic information to P&T Committees.

Objectives:

1.	Identify the typical members of a Pharmacy and Therapeutics (P&T) Committee and characterize the role of subcommittees.
2.	Describe the decision process that a P&T Committee follows when conducting and evaluating formulary submissions and supporting pharmacoeconomic studies.
3.	Describe strategies a pharmaceutical sales professional can use when presenting pharmacoeconomic information to a P&T Committee.


    
    

Structure of a Pharmacoeconomic Study

Introduction: This module describes the basic structure of a true pharmacoeconomic study and explains the role of each of its necessary components.

Objectives:

1.	Describe the components of a pharmacoeconomic study’s problem statement.
2.	Explain the factors that determine which costs and outcomes are examined by a pharmacoeconomic study, and how they are measured and analyzed.
3.	Identify the types of data sources used by pharmacoeconomic studies.
4.	Describe how modeling and data-analysis techniques—including decision trees, Markov models, Monte Carlo simulations, and regression analyses—are used in pharmacoeconomics.
5.	Describe how a study’s limitations, generalizability, and applicability can be defined for its audience.


    
    

Benefits of Pharmacoeconomic Research

Introduction: This module examines how pharmacoeconomic research can benefit all healthcare stakeholders, including third-party payers; pharmacy benefit management companies (PBMs); hospitals and other healthcare organizations; physicians; patients, their families, and employers; life science companies, and society as a whole. This module also explains the different perspectives these purchasers, providers, and patients may have regarding the objectives of pharmacoeconomic research.

Objectives:

1.	Identify ways in which pharmacoeconomic strategies influence government programs and other third-party payers.
2.	Explain how pharmacoeconomic research can benefit hospitals, other healthcare organizations, and physicians.
3.	Explain ways in which patients, their families, employers, and society may benefit from pharmacoeconomic research.
4.	Explain how pharmacoeconomic research can benefit life science companies and their sales professionals.
5.	Explain how the different perspectives of providers, payers, patients, and society affect the design and presentation of pharmacoeconomic studies.


    
    

Outcomes Research and Management

Introduction: To better understand what pharmacoeconomics is, it may help to view it in its larger research context: outcomes research, comparative effectiveness research (CER), pharmacoeconomics. Likewise, to better understand how pharmacoeconomics can improve healthcare delivery, it may help to view it in the larger context of outcomes management, and to see how it is applied to a subset of that discipline, disease management. This module provides that context, with a detailed look at outcomes research and comparative effectiveness research, and outcomes management, including disease management programs.

Objectives:

1.	Differentiate between outcomes research and outcomes management.
2.	Explain the concept of comparative effectiveness research (CER) and the role the federal government has played in its implementation.
3.	Explain the concept of disease management and describe how it relates to outcomes management and pharmacoeconomics.


    
    

Pharmacoeconomic Methods of Analysis

Introduction: This module describes the key components, and the advantages and disadvantages, of the four most frequently used pharmacoeconomic methods of analysis: • Cost-benefit analysis (CBA) • Cost-effectiveness analysis (CEA) • Cost-minimization analysis (CMA) • Cost-utility analysis (CUA)

Objectives:

1.	Describe the components, advantages, and disadvantages of a cost-benefit analysis (CBA).
2.	Differentiate between various factors, analyses, and outcomes used to measure costs in a cost-effectiveness analysis (CEA).
3.	Describe methods used to present results in a cost-effectiveness analysis (CEA).
4.	Distinguish between the appropriate and inappropriate use of a cost-effectiveness analysis (CEA).
5.	Explain the appropriate type of situation in which to use a cost-minimization analysis (CMA).
6.	Identify situations in which a cost-utility analysis (CUA) is an appropriate analysis to use.
7.	Describe various scales, indices, and methods used for measuring health-related quality of life.


    
    

Trends Influencing Pharmacoeconomic Research

Introduction: Current trends that will influence the direction of pharmacoeconomic research discussed in this module include: • More types of healthcare stakeholders are using pharmacoeconomic data, and for more varied purposes. • More standards and guidelines for pharmacoeconomic studies are available, globally and nationally. • Emerging technologies—notably specialty-drug biotechnologies, pharmacogenomics, and health information technologies—are providing new opportunities for, and challenges to, the use of pharmacoeconomics.

Objectives:

1.	Describe how different healthcare stakeholders are expanding their uses of pharmacoeconomic studies.
2.	List organizations that are developing and promoting standards and guidelines for pharmacoeconomic evaluations.
3.	Explain how emerging technologies, such as specialty drugs, pharmacogenomics and health information technologies, create new opportunities and challenges for pharmacoeconomics.


    
    

An Introduction to Specialty Drugs

Introduction: This module introduces you to specialty pharmaceuticals by addressing the following key questions: - Why are specialty drugs significant? - What are their key characteristics?

Objectives:

1.	Explain the significance of specialty drugs.
2.	List the key defining characteristics of specialty drugs and describe each characteristic's implications for the specialty marketplace.


    
    

Specialty Drugs: Distribution and Reimbursement

Introduction: This module describes how distribution and reimbursement differ under the medical ("buy-and-bill") and pharmacy benefit models. It explains why these models, which were designed for traditional drugs, become problematic when used to distribute and reimburse specialty drugs. It views these issues from the perspectives of payers, providers, and patients. Finally, it looks at current attempts to adapt and adjust these models to better fit the needs of the specialty drug supply chain.

Objectives:

1.	Explain the differences between the medical ("buy-and-bill") and pharmacy reimbursement models and why they present a dilemma for specialty drugs.
2.	Describe the three main methods of distributing and reimbursing provider-administered specialty drugs.
3.	Explain how reimbursement model choices impact payers, providers, and patients.
4.	Describe innovative attempts to adapt or replace traditional reimbursement models for specialty drugs.


    
    

The Dynamics of the Specialty Supply Chain

Introduction: To construct a persuasive value proposition for a specialty drug, you first need to understand the “business of specialty drugs.” This module describes the business systems that move specialty drugs through the market, including: • How specialty drugs are distributed and reimbursed through the medical benefit or pharmacy benefit. • How decisions are made in the supply chain. • The role support services play, such as in-patient adherence assistance and data management.

Objectives:

1.	Describe the ways in which specialty drugs’ complexity and cost “disrupt” the traditional pharmaceutical supply chain.
2.	Identify support services provided by specialty stakeholders.
3.	Describe the dynamics of supply chain decision-making.


    
    

Specialty Drugs: Stakeholders and Market Trends

Introduction: Many stakeholders are engaged in the specialty market. For example, physicians must carefully weigh the risks and rewards of “buy-and-bill” distribution of specialty drugs. This module explains some of the key players and issues in the specialty market by addressing the following key questions: • Who are the key specialty pharmaceutical stakeholders? • What direction is the specialty market taking?

Objectives:

1.	Identify the major specialty drug stakeholders and their respective priorities and concerns.
2.	Describe current and imminent trends in the specialty market.


    
    

Understanding Physicians through Relationship Selling

Introduction: This module looks at different motivations and personality traits of physicians. It describes the concept of relationship selling and explores what physicians want from sales professionals.

Objectives:

1. Explain how different motivations and personality traits of physicians can influence the sales approach.
2. Describe relationship selling and evaluate your strengths and weaknesses against the expectations physicians have of sales professionals


    
    

Role of Nonprimary Care Specialist in the 21st Century

Introduction: This module defines the term nonprimary care specialist, and looks at the relationship between primary care physicians and specialists. It describes the effect of managed care on specialists, looks at trends in specialty care, and considers the role of hospitalists.

Objectives:

1. Define the term nonprimary care specialist, and characterize the relationship between primary care physicians and specialists.
2. Describe the effect of managed care on specialty physicians.
3. Identify trends in specialty care medicine.
4. Describe hospitalists and how they influence care delivery.


    
    

Primary Care Physicians in the 21st Century

Introduction: This module defines primary care, describes the conditions these physicians typically treat, looks at their role in a managed care environment, and explores trends related to the interest in primary care among medical students.

Objectives:

1. Define primary care and list the responsibilities of primary care physicians.
2. Describe the conditions primary care physicians treat.
3. Describe the role of gatekeepers in managed care.
4. Explain trends related to medical students' interest in primary care.


    
    

Healthcare as a Business

Introduction: This module discusses what drives healthcare as a business, how physicians are responding to the evolving healthcare environment, and the ways in which information technology is shaping how physicians practice.

Objectives:

1. Discuss what drives medicine from a business perspective.
2. Describe how physicians are responding to the evolving 21st century healthcare environment.
3. Describe the various ways in which physician practices use technology.


    
    

Identifying Partnering Opportunities

Introduction: This module explores various opportunities for partnerships that can result in a competitive edge while helping physicians meet current challenges.

Objectives:

1. Describe how life science companies can help physicians overcome the challenges associated with managed care mechanisms, such as tiered formularies, disease management programs, and risk-sharing financial arrangements.
2. Describe how sales professionals and their managers can help physicians in a litigious environment.
3. Explain how sales professionals and their managers can help physicians meet patient-related challenges in areas associated with increased Internet research, patient privacy regulations, and aging of the population.


    
    

Key Issues Affecting Physician Practices

Introduction: This module introduces you to important aspects of the setting in which 21st century physicians practice.

Objectives:

1. Describe how the rising cost of healthcare influences physician practices.
2. Describe the effect of litigation on physician practices.
3. Describe the effect of information technology on physician practices.


    
    

Patient Physician Interactions

Introduction: This module discusses the impact of the Internet and the pros and cons of DTC advertising. It explores the communication skills patients want from their physicians, and describes how managed care plans affect patient/physician relationships.

Objectives:

1. Explain how informatics and the Internet affect patient-physician interaction.
2. Describe the arguments for and against direct-to-consumer (DTC) advertising, and characterize the regulatory efforts associated with DTC advertising.
3. Describe what patients look for in a physician.
4. Explain how elements of managed care can affect patient-physician interactions.


    
    

Effective Evidence-Based Medicine Oriented Sales Calls

Introduction: This module assumes the representative conducts pre-call planning with an EBM strategy (and objective) in mind.

Objectives:

1.	Characterize the various elements of an EBM-oriented sales call.
2.	Describe the effective use of clinical reprints when time constraints are significant.


    
    

Essential Elements of Clinical Trials

Introduction: This module provides a brief introduction to the general types of clinical trials, trial protocols, trial endpoints, underlying principles that govern trials, and the patient enrollment process. These are all important topics in the context of meeting with clinicians to discuss or compare the evidence that supports a specific therapy in patient management.

Objectives:

1.	Distinguish between the different types of clinical trials used in R&D.
2.	Describe the purpose of a trial protocol.
3.	Define endpoint and differentiate among the types of trial endpoints.
4.	Describe the general principles that guide the conduct of all clinical trials.
5.	Explain the concept of eligibility criteria as it applies to clinical trials.


    
    

Evaluating the Importance and Clinical Relevance of Study Results

Introduction: This module examines three questions that pertain to the real value and implications of a trial: What is the magnitude of the treatment effect? What is the precision of the treatment effect? Was the sample size large enough to achieve adequate statistical power?

Objectives:

1.	Distinguish between absolute risk reduction and relative risk reduction as measures of treatment effect.
2.	Describe the importance of effect size and confidence intervals.
3.	Describe the importance of sample size and statistical power in determining clinical relevance.


    
    

Evidence Based Medicine as a Sales Strategy

Introduction: This module looks at EBM as a sales strategy, considers the regulatory implications, and outlines an approach to planning an EBM sales call.

Objectives:

1.	Describe how an EBM sales strategy can facilitate valuable interactions between healthcare representatives and clinicians.
2.	Describe the regulatory implications for EBM as a sales strategy.
3.	Characterize the pre-call planning process for defining and implementing EBM objectives.


    
    

Experimental Designs

Introduction: This module describes the most common experimental designs, including prospective and retrospective studies, cohort studies, case-control studies, and randomized-controlled trials (RCTs). The module also distinguishes systematic reviews from meta-analyses and looks at the relationship between research design and the level of evidence.

Objectives:

1.	Distinguish between prospective and retrospective studies.
2.	Describe the nature of and reasons to conduct cohort studies.
3.	Describe the nature of and reasons to conduct a case-control study.
4.	Describe randomized controlled trials and distinguish between parallel and crossover designs.
5.	Differentiate between a systematic review and a meta-analysis.
6.	Describe healthcare data analyses and cost-effectiveness models.
7.	Describe the level of evidence that results from different study designs.


    
    

Factors that Affect the Validity of Trial Results

Introduction: This module helps you answer several relevant questions: Were patients randomly assigned to the different study groups? Were all patients accounted for at the conclusion of the study? Were the patients, clinicians, and study trial personnel blinded to the condition(s) to which patients were enrolled? Were characteristics of the groups similar at baseline? Were the groups treated equally, except for the investigational intervention? Can the diagnostic tests used be validated against a gold standard?

Objectives:

1.	Explain the significance of randomization.
2.	Describe the effect of withdrawal rates on the validity of study results.
3.	Describe the use of blinding to reduce bias.
4.	Explain the importance of knowing each study group’s baseline characteristics.
5.	Explain the roles of sensitivity and specificity in validating a test.


    
    

History and Definition of Evidence-Based Medicine

Introduction: This module describes the historical background of EBM and defines the term as it is used today. It also describes the three main components of EBM and how they can be integrated with a patient-centric approach to care.

Objectives:

1.	Describe the history of evidence-based medicine and the factors that have contributed to its development and evolution.
2.	Define evidence-based medicine and describe its primary objective in clinical practice applications.
3.	Characterize the three main components of evidence-based medicine.


    
    

Methods of Controlling Bias in Clinical Trials

Introduction: This module explores how control groups, placebos, and blinding help to minimize bias.

Objectives:

1.	Describe important attributes of control groups and explain how they reduce bias.
2.	Distinguish among other forms of controlling bias, including blinding, double dummy, and open label designs.


    
    

Opportunities Behind the Clinician's Evidence-Based Medicine Challenge

Introduction: This module looks at why clinicians often find it challenging to integrate evidence-based medicine (EBM) into clinical decision-making, and how their challenge can become your opportunity. Clinicians are more likely to be responsive to your product message if you become skilled at examining trial results from their viewpoint and providing evidence through study reprints and other support materials.

Objectives:

1.	Describe the challenges clinicians face in the implementation of EBM.
2.	Evaluate trial results from a clinician’s perspective.
3.	Describe how the package insert and other evidence-based support materials can be of value in the context of an EBM call strategy.


    
    

Postmarketing Drug Research

Introduction: This module looks at the types of research that occur typically as postmarketing investigations—ie, when the drug is approved and in wide-scale clinical use. Such investigations include - FDA postmarketing surveillance (Phase IV) investigations to confirm a product’s ongoing safety and Studies to evaluate a product’s value in relation to alternative approved therapies - Comparative effectiveness research (CER), Pharmacoeconomic studies, and Non-inferiority studies.

Objectives:

1.	Describe the FDA’s postmarketing surveillance program, including the roles of FAERS and MedWatch.
2.	Describe postmarket studies of a product’s relative value, including comparative effectiveness research (CER), pharmacoeconomic studies, and non-inferiority studies.  


    
    

Research Protocols

Introduction: This module discusses the makeup of a research protocol and introduces you to several important concepts related to study design.

Objectives:

1.	Describe the essential components of a research protocol and the concepts that are applied in protocols.


    
    

Research Reports and the Role of Statistical Analysis

Introduction: This module discusses the benefits that published literature brings to the healthcare community and helps you determine which publications are likely to be most credible. It also sets the stage for understanding the contents of a research report by explaining the role of statistics in establishing a significant difference and the types of errors that may occur in statistical analysis.

Objectives:

1.	Describe the benefits of literature published in peer-reviewed journals to the practice of evidence-based medicine in clinical decision-making.
2.	Describe the role of statistics and statistical tests as applied to the concept of significant difference.
3.	Describe the risk of error and distinguish between false positive errors and false negative errors in study results.


    
    

Sources of R and D Funding

Introduction: This module looks at where the funding comes from and distinguishes grants from contracts.

Objectives:

1.	Describe the major types of organizations that currently fund research for the development of interventions that prevent, treat, or manage disease conditions.
2.	Distinguish between research grants and research contracts.
3.	Distinguish between “upstream” and “downstream” research.


    
    

The Anatomy of a Clinical Reprint

Introduction: This module discusses the six standard sections of a clinical reprint—Abstract, Introduction, Methods, Results, Discussion, References. Your familiarity with these sections will help you: Navigate as needed within your own clinical reprints; Link clinical reprints with issues of interest to clinicians; Respond to clinical questions with trial-based evidence; Bring new focus to your interactions with clinicians.

Objectives:

1.	Differentiate among the various sections of a clinical reprint relative to purpose, general content, and significance.


    
    

The Current Status of Evidence Based Medicine

Introduction: This module considers the current status of EBM in the context of the challenges it aims to help clinicians face, and the shortcomings of traditional clinical decision-making support solutions.

Objectives:

1.	Describe the challenges today’s healthcare providers face in making informed clinical decisions.
2.	Explain the shortcomings of traditional approaches to clinical decision-making.
3.	Describe the current status of evidence-based medicine in clinical use, including its challenges and limitations.


    
    

The Drug Development Process

Introduction: This module provides an overview of the process involved in taking a new drug from the laboratory to clinicians’ offices.

Objectives:

1.	Describe the stages of drug development that occur before studies can be conducted on human subjects.
2.	Describe the NDA/BLA approval process, including FDA expedited approval options.
3.	Differentiate between Phase I, II, and III clinical trials according to their purpose, design, and number and types of study participants.


    
    

Trial Design from a Clinical Perspective

Introduction: This module looks at study design from a clinical perspective. It explains which types of studies apply most appropriately to various kinds of clinical inquiry and explores the comparative elements that are unique to therapeutic trials, making them especially valuable in EBM discussions.

Objectives:

1.	Determine which types of research design are best suited to answering different kinds of clinical questions.
2.	Distinguish between comparative concepts in therapeutic trial design, including superiority, equivalence, and non-inferiority.
3.	Explain the concept of dose-response relationship.


    
    

Understanding the Evidence-Based Medicine Process

Introduction: This module describes the steps that comprise the evidence-based medicine (EBM) process. A case example demonstrates how EBM can enhance clinical decision-making and improve patient outcomes.

Objectives:

1.	List and describe the five steps involved in the process of evidence-based medicine.


    
    

Protecting Market Access as Biosimilars Emerge

Introduction: The entry of biosimilars into the US marketplace will likely create a more competitive environment that could affect market access for all products in a therapeutic category. This module describes some of the strategies that biopharmaceutical companies might use to protect market access and identifies opportunities for sales teams to continue to serve their customers in the face of greater competition.

Objectives:

1.	Discuss pricing, coverage, and payment of biosimilars in the US.
2.	Describe some of the strategies that biopharmaceutical companies may use with payers to protect market access when selling for or against biosimilars.
3.	Identify some of the strategies that biopharmaceutical companies may use with providers to protect market access when selling for or against biosimilars.
4.	Understand what sales teams can do as biosimilars become more prevalent.


    
    

The Entry of Biosimilars into the US Market

Introduction: More biosimilars are expected to enter the US market in the coming years, potentially creating a more competitive market for biologic products and other competitive products. Understanding the basics of biosimilars is crucial for sales teams with products that treat conditions such as rheumatoid arthritis, anemia, inflammatory bowel disease, skin conditions, and some cancers. This module explains how biosimilars are developed and the key concept of interchangeability. It also describes how customers view the emergence of biosimilars, including their expectations for how the products could affect healthcare costs in the US.

Objectives:

1.	Define what biosimilars are and how they are made.
2.	Explain the concept of interchangeability as it relates to biosimilars.
3.	Identify some of the key federal and state regulations affecting biosimilars in the US.
4.	Describe lessons learned from the introduction of biosimilars in other countries.
5.	Explain why customers are interested in biosimilars and how biosimilars could affect the US market.


    
    

Crisis in US Healthcare--Costs, Access, and Quality

Introduction: This module discusses three significant healthcare challenges–cost, quality, and access – and provides an overview of business management practices being adopted in healthcare to address these challenges.

Objectives:

1.	Discuss the primary contributors to high healthcare costs.
2.	Explain why access to care and quality of care are still challenges.
3.	Highlight how clinician well-being contributes to high-quality care and high costs.
4.	Describe how the adoption of business management practices in healthcare can help to control costs and improve the quality of medical care.


    
    

Current Issues in Managing Healthcare

Introduction: This module explores issues facing healthcare stakeholders as they make decisions related to managing and improving healthcare.

Objectives:

1.	Describe concepts and tools that guide value-based decision making in healthcare.
2.	Describe how healthcare organizations are managing the purchasing process.


    
    

Impact of Value-Based Healthcare on the Sales Environment

Introduction: This module reviews the implications of managed care for sales professionals. It looks specifically at how value-based approaches to healthcare are impacting the sales process and the sales professionals’ role.

Objectives:

1.	Describe ways in which the managed care environment, including the emphasis on value-based care, impacts the sales efforts of sales professionals.
2.	Explain the impact of various streamlining approaches in healthcare on sales professionals.
3.	Summarize how streamlining in the life science industry has affected the role of sales professionals.


    
    

Improving Quality through CMS Initiatives, Benchmarking, and Customer Relationship Management

Introduction: This module discusses quality improvement initiatives undertaken by the Center for Medicare and Medicaid Services (CMS). It describes the concepts of benchmarking and customer relationship management (CRM), and gives examples of how these approaches are used in healthcare.

Objectives:

1.	Describe various improvement initiatives by the Centers for Medicare and Medicaid Services (CMS).
2.	Explain the term benchmarking, describe its process, and give examples of how it’s used in healthcare.
3.	Describe customer relationship management (CRM) and explain how it is used in healthcare.


    
    

Managed Care--An Evolving Approach

Introduction: This module explores the evolution of managed care from an approach that restricted choices and options, mainly as a way to control costs, to a broader performance improvement methodology that focuses on managing the quality, experience, and cost of care provided to a defined population of patients or members.

Objectives:

1.	Describe the general concept and features of managed care and how this approach has evolved.
2.	Characterize the types of managed care organizations.
3.	Describe the evolving impact of managed care on the life science industry.


    
    

Streamlining Healthcare through Integration, Alliances, and Outsourcing

Introduction: This module discusses three strategies (integrated delivery networks, alliances, and outsourcing) that are borrowed from business management to streamline healthcare delivery.

Objectives:

1.	Characterize healthcare integration and cite examples of it, including integrated delivery networks and ACOs.
2.	Explain how alliances are used in the healthcare industry and the benefits they can offer.
3.	Describe outsourcing in healthcare organizations, including its advantages and risks.


    
    

Streamlining Healthcare through Reengineering and Consolidation

Introduction: This module reviews two streamlining strategies (reengineering and consolidation) that are borrowed from business management.

Objectives:

1.	Define the term reengineering and describe the steps involved in this process.
2.	Explain how reengineering and innovation may be applied to healthcare.
3.	Describe consolidation as it has occurred among various healthcare entities.


    
    

The Evolving Structure of Life Science Sales

Introduction: This module looks at how horizontal management and its emphasis on teamwork, as well as the changing landscape of decision makers, are influencing life science sales.

Objectives:

1.	Explain how horizontal management in life science sales influences the sales process and the sales professionals’ role.
2.	Identify current decision makers and how they may influence the sales process.
3.	Recognize how behavioral economics affects decision making in today’s value-conscious environment.


    
    

Using Continuous Quality Improvement and High-Reliability Approaches to Improve Healthcare

Introduction: This module discusses two well-known quality improvement strategies that healthcare has adapted from the business community: continuous quality improvement (CQI) and Six Sigma.

Objectives:

1.	Characterize continuous quality improvement (CQI), including the concept of rapid cycle improvement, and explain the benefits and drawbacks of CQI.
2.	Identify and describe the basic tools used in CQI.
3.	Describe a high-reliability organization and the various approaches used to attain high reliability, including Six Sigma.


    
    

Selling in a Value Conscious Environment

Introduction: This module discusses how disease management, technology, and value-based services and products can contribute to win-win partnerships.

Objectives:

1.	Explain the emphasis on quality and the value of supporting disease management in a quality-conscious environment.
2.	Describe various ways in which technology is enhancing the quality of healthcare.
3.	Identify particular ways in which the products and services of life science companies can be of value to quality-conscious healthcare organizations.


    
    

Ethics in Life Science Marketing and Advertising

Introduction: This module describes the US regulations regarding marketing and advertising; the ways in which the FDA seeks to ensure that advertising is accurate, fair, and balanced; and the guidelines on consumer advertising issued by PhRMA for its members.

Objectives:

1. Describe the FDA's framework for regulating medical product marketing, including key definitions and requirements, and communications and enforcement mechanisms. 
2. Describe key ethical issues of direct-to-consumer (DTC) advertising, and FDA and industry responses to them.


    
    

Late 19th and 20th Century US Legislation

Introduction: Early US legislation laid the groundwork for the establishment of the FDA and its mission?to prevent misbranding and commerce in adulterated, unsafe, or ineffective products. A process for licensing medicines began to take shape. In response to tragic events, the federal government set standards of proof of efficacy and safety that pharmaceutical manufacturers must provide before they can market their medicines in the US. New laws and older ones were used to address emerging problems, such as drug abuse and Medicare/Medicaid fraud. The first regulations regarding promotion of products became law. This module describes how these early laws helped shape the present regulatory environment in the US.

Objectives:

1. Identify the key features of late 19th and 20th century US laws regulating and influencing the life science industry.


    
    

Ethical Dimensions of Research Decisions

Introduction: This module discusses the ethical issues that underlie practical research decisions, as well as the Statements of Principle and Good Clinical Practice (GCP) documents that aim to help guide such ethical choices.

Objectives:

1. Describe the types of ethical decisions that life science companies must make in planning and designing clinical research.
2. Describe the purpose, scope, and impact of statements of ethical principles such as the Declaration of Helsinki, the Belmont Report, and PhRMA Principles.
3. Describe the purpose, scope, and impact of the ICH and ISO Good Clinical Practice (GCP) guidelines.


    
    

Ethical Issues Related to Drug Safety Monitoring, Pricing, and Off-Label Promotion

Introduction: Life science companies have ethical responsibilities beyond compliant advertising and promotional activities. Increasingly, manufacturers are being held accountable for the safety of their products once they have entered the marketplace. In addition to reporting issues associated with their products, companies may be required by the FDA to take additional risk mitigation steps. Companies doing business with certain federal programs must comply with pricing rules, but they must also consider the broader ethical implications of the prices they charge for their products, weighing public good against the needs of the organization and future product development. Sales professionals must also be familiar with their companies' policies on the issue of off-label promotion - what they can and cannot do when a prescriber asks about using a medicine for an indication not specifically approved by regulatory authorities. This module examines regulatory and industry response to these issues.

Objectives:

1. Describe ethical and regulatory obligations related to the task of pharmacovigilance.
2. Describe ethical issues regarding pricing of medical products, and life science industry responses to them.
3. Describe regulatory restrictions on off-label promotion of medical products.


    
    

Ethical Responsibilities when Conducting Clinical Trials

Introduction: This module discusses ethical issues that are of importance during and subsequent to the conduct of a clinical trial.

Objectives:

1. Describe the Common Rule and its basis in the Belmont Report.
2. Describe the role and constitution of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs).
3. Discuss issues associated with obtaining informed consent from clinical trial participants.
4. Describe the purpose and process of safety reporting during a clinical trial.
5. Discuss attempts to ensure the complete and accurate publication of clinical trial data.


    
    

Ethics in Interactions with Healthcare Professionals

Introduction: This module focuses on these issues, including a discussion of promotional gifts and educational support. It also discusses industry guidelines for interactions between life science sales representatives and healthcare professionals, which aim to prevent abuse of promotional practices.

Objectives:

1. Describe the ethical challenges of financial relationships between manufacturers and healthcare providers, and legislative responses to them.
2. Explain the ethical issues raised by product sampling, and how the Prescription Drug Marketing Act (PDMA) addresses them.
3. Describe the different perspectives of ethical codes of life science and healthcare provider associations.


    
    

Key International Regulatory Bodies and Groups Associated with Ethics and Compliance

Introduction: This module focuses on international groups involved in such harmonization efforts. This includes government agencies that implement regulations and monitor compliance in the European Union (EU), Japan and the US, whose governments have been most active in international efforts to harmonize life science industry regulations. We then focus on international associations that articulate ethical goals and work to translate those goals into globally accepted standards and practices.

Objectives:

1. Identify and describe the purposes and processes of international organizations that generate ethical guidelines and regulatory mandates.


    
    

Key US Regulatory Bodies and Groups Associated with Ethics and Compliance

Introduction: This module focuses on the US-based groups involved in influencing, generating, and enforcing mandates in the life science industry, including the government agencies that implement regulations and monitor compliance. It then discusses the professional and industry associations that issue voluntary guidelines to ensure ethical behavior among their members.

Objectives:

1. Identify and describe the purposes and processes of US government agencies that generate ethical guidelines and regulatory mandates, including the FDA, HHS, and DEA.
2. Identify and describe the professional and industry associations that develop ethical guidelines, including PhRMA, AdvaMed, the AMA, and the ACCME.


    
    

Late 20th and 21st Century US Legislation

Introduction: Trends in recent US legislation have focused on increasing transparency in promotional activities of life science companies, protecting patient privacy, reducing drug costs, addressing opioid abuse, and finding a balance between improving patient safety and speeding access to innovative medical products. This module focuses on legislation that has been enacted at the federal level, such as the Prescription Drug Marketing Act, HIPAA, FDAAA, the Affordable Care Act (ACA), the 21st Century Cures Act, the Bipartisan Budget Act of 2018, and the SUPPORT for Patients and Communities Act. Trends in federal legislation and state and local laws are also discussed.

Objectives:

1. Identify the key features of US laws regulating and influencing promotional and other activities of the life science industry.
2. Characterize trends in federal and state legislation.


    
    

Regulatory and Ethical Compliance in the Life Sciences

Introduction: This module describes the sources and scope of mandates affecting the life science industry, their purpose, the risks of noncompliance to companies and individuals, and the steps pharmaceutical manufacturers take to ensure and demonstrate compliance.

Objectives:

1. Describe the variety of ethical precepts, regulations, and guidelines with which sales professionals must comply.
2. List the fundamental goals of regulatory and ethical mandates.
3. Explain the risks of noncompliance with regulatory and ethical mandates.
4. Describe the strategies employed by life science manufacturers to ensure and document compliance.


    
    

Analyzing the Sales Situation

Introduction: This module discusses the importance of accurate business analyses and the various tools and processes that might be used to analyze a territory and forecast sales.

Objectives:

1.	Describe how district managers use sales data from various services to analyze current sales situations.
2.	Describe the purpose of future situation analyses and identify the factors that could influence future sales.


    
    

Attracting Appropriate Candidates for Sales Roles

Introduction: Since the success of district managers depends upon the success of their sales team, they coordinate recruiting activities with Human Resources. They should become as involved as the company allows when healthcare sales professionals who will be working in their districts are being recruited.

Objectives:

1.	Explain the purpose and components of an effective job description.
2.	Explain how a candidate profile can be used in attracting qualified candidates and differentiate between required skills and desired skills.
3.	Describe effective recruiting options and activities for district managers.


    
    

Facilitating District Meetings

Introduction: This module focuses on facilitating formal group or district meetings. It begins with discussion of the district manager’s roles regarding planning meetings and then describes the characteristics of successful face-to-face district meetings.

Objectives:

1.	Describe the key aspects of planning for district meetings.
2.	Describe the characteristics of successful district meetings.


    
    

Collaborating Within and Beyond Your District

Introduction: This module focuses on the role of district managers in working effectively with sales and other departments within the company and possibly outside the company, such as co-promote partners.

Objectives:

1.	Identify key elements of successful collaborations.
2.	Explain the role of district managers in working with the Sales Department and other departments and divisions within their companies.
3.	Explain how district managers can work successfully with co-promote partners.


    
    

Managing Resources in Your District

Introduction: This module focuses on three important resources available to district managers—time, finances, and technology/automation.

Objectives:

1.	Describe techniques district managers use to manage their own time efficiently and assist healthcare sales professionals with time management.
2.	Describe the process that district managers should follow to obtain budgets and manage expenses in an efficient manner.
3.	Describe how the use of technology and automation can assist with efficient management of resources.


    
    

Creating and Implementing a Business Plan

Introduction: The business plans of healthcare sales professionals represent cooperative efforts between the sales professional and district manager, who guides the sales professional in plan development, approves the plan, and monitors its implementation. In addition, district managers must write their own plans. This module discusses the content and process for creating both types of plans.

Objectives:

1.	Describe the components of a business plan.
2.	Describe how a district manager's business plan differs from that of their healthcare sales professionals.


    
    

Leadership: The Most Important District Manager Competency

Introduction: This module begins by characterizing leadership and then discusses leadership behaviors and the ways in which leadership skills can be assessed. It concludes with a description of leading theories and models of leadership.

Objectives:

1.	Identify key characteristics of leaders.
2.	Describe the behaviors and actions typical of a leader.
3.	Explain how leadership skills can be evaluated.
4.	Compare and contrast leadership styles and models.


    
    

Managing Dynamic Change at the District Level

Introduction: This module describes a model for managing change, including the role of district managers during the various phases of change. Then, it discusses how district managers can help manage change related to some specific internal and external factors, including mergers and acquisitions, the managed care environment, evolving practices, and pressures to make healthcare products more accessible to patients.

Objectives:

1.	Describe the Transition Model for managing change and the role of effective district managers during each phase.
2.	Describe the role of the district manager during mergers or acquisitions.
3.	Identify factors that can impact product sales in a managed care environment.
4.	Describe how district managers can help their sales professionals respond to the needs of healthcare providers.
5.	Explain how district managers can prepare their sales professionals to respond to objections about product pricing and access.


    
    

Measuring Performance of Healthcare Sales Professionals

Introduction: This module discusses the benefits of appraising performance, describes the rating systems commonly used, and offers suggestions for planning and conducting appraisal meetings.

Objectives:

1.	Describe the benefits of performance appraisals.
2.	Identify the key features of current appraisal systems.
3.	Explain how effective district managers prepare for and conduct performance appraisal meetings.


    
    

Motivating Healthcare Sales Professionals

Introduction: This module describes the district manager’s role in using tangible motivators to reward positive results. It discusses the varied factors that motivate individuals and concludes with basic guidelines for motivating others.

Objectives:

1.	Describe how district managers can use tangible and intangible motivators appropriately to achieve the best sales results.
2.	Identify basic guidelines for district managers to motivate their sales professionals to improve performance.


    
    

Sales and Management Competencies

Introduction: This module provides an overview of sales and management competencies. It begins with a review of important sales competencies. It then points out the differences and similarities between competencies companies expect of their healthcare sales professionals and those they expect of their district managers.

Objectives:

1.	Describe important healthcare sales professional competencies.
2.	Describe important district manager competencies.
3.	Compare and contrast the competencies of sales professionals and district managers.


    
    

Screening and Selecting Candidates for Sales Roles

Introduction: This module discusses how district managers should screen and select the best candidates for the healthcare sales professional position. Screening involves reviewing r�sum�s, conducting interviews, and checking references and other related information to select the most qualified candidate who will work effectively with other members of the sales team.

Objectives:

1.	Explain approaches that district managers should follow when screening candidates via resumes or telephone interviews.
2.	Characterize important aspects of traditional and nontraditional interviewing techniques, including appropriate and inappropriate questions.
3.	Describe approaches that district managers can use to help make a final hiring decision.


    
    

District Team Development and Management

Introduction: This module describes district managers' responsibilities during the stages of team development and how district managers can create effective working environments. It also discusses territory alignment and deployment of the sales professionals who make up district teams. It concludes with a discussion of how district managers can empower their teams.

Objectives:

1.	Compare the role of district managers during each stage of team development as defined in the Tuckman model of team development.
2.	Explain the role of the district manager in creating a team culture.
3.	Describe the factors that district managers must consider when aligning territories and deploying healthcare sales professionals.
4.	Describe techniques that district managers can use to empower their district teams.


    
    

Training, Coaching, and Mentoring Healthcare Sales Professionals

Introduction: This module focuses on district managers' responsibilities in the areas of training, coaching, and mentoring.

Objectives:

1.	Describe the roles and responsibilities of district managers during the induction and initial training stages for newly hired healthcare sales professionals.
2.	Explain district managers' ongoing responsibilities in terms of coaching, mentoring, and ongoing testing.
3.	Describe the current recommendations in sales management literature for maximizing the benefits of training, coaching, and mentoring.


    
    

Administering the Pharmacy Benefit

Introduction: This module begins with a discussion of the role of prescription drugs in the delivery of healthcare services and what is meant by the pharmacy benefit. It then discusses the role of PBMs in managing the pharmacy benefit and how financial risk is influencing the pharmacy benefit.

Objectives:

1.	Explain the role of prescription medicines in healthcare delivery compared with other treatment alternatives.
2.	Describe the functions of PBMs.
3.	Explain the purpose of specialty pharmacies.
4.	Describe how pharmacy-related financial risks can be managed through pharmacy benefit design and by partnering with prescribers.


    
    

Medicare and Medicaid Formularies

Introduction: This module explores the role of formularies in controlling healthcare costs under two major public programs—Medicare and Medicaid.

Objectives:

1.	Describe formulary use by Medicare.
2.	Explain how Medicaid programs use formularies.


    
    

Criteria for Product Approval to the Formulary

Introduction: This module focuses on the formulary approval process in both managed care organizations and hospitals, and how decisions are made regarding which drugs are approved for formulary inclusion.

Objectives:

1.	Describe the key criteria used in determining product approval to the formulary.
2.	Describe the tools that have been developed to assist in the formulary decision-making process.


    
    

Formulary Design

Introduction: This module describes three major formulary design concepts: open, closed, and multi-tier, and discusses an emerging approach to formulary structure: value-based formulary design.

Objectives:

1.	Describe the three common types of formulary design: open, closed, and multi-tiered formularies.
2.	Describe the concepts underlying value-based formulary design.


    
    

Hospital and Managed Care Formularies

Introduction: This module discusses the use of formularies in hospital and managed care organizations (MCOs).

Objectives:

1.	Describe the purpose, development, implementation, and maintenance of hospital formularies.
2.	Explain how formularies are used in managed healthcare organizations.


    
    

Role of Clinicians and Pharmacists in Managing the Pharmacy Benefit

Introduction: This module focuses on the role of clinicians and pharmacists in pharmacy benefit management.

Objectives:

1.	Describe the role of the clinician in pharmacy benefit management.
2.	Explain how pharmacists can be involved in pharmacy benefit management.


    
    

Selling in the Formulary Environment

Introduction: This module discusses how pharmaceutical companies have responded to and are succeeding in a formulary environment. Their strategies include negotiating with buying groups, creating new departments within the company, expanding research initiatives, and ensuring representatives are prepared to prosper in this complex setting.

Objectives:

1.	Describe various strategies that pharmaceutical companies use to attain formulary status.
2.	Identify the representative’s role in the formulary system.
3.	Recommend actions that can help maintain a drug on formulary.
4.	Suggest appropriate responses for when a drug is not approved for formulary.


    
    

Strategies for Managing the Pharmacy Benefit

Introduction: This module describes the key methods used by health plans, insurers, and hospitals to manage the pharmacy benefit.

Objectives:

1.	Describe how formularies are used to share the cost of the pharmacy benefit with patients.
2.	Describe strategies used to influence clinicians' prescribing habits and pharmacies' dispensing of prescriptions.
3.	Describe how formulary control measures, including prior authorization and generic substitution and therapeutic interchange, are used to change product use levels and patterns in MCOs.
4.	Describe the DUE process and the different types of DUEs.
5.	Describe how clinical practice guidelines, step care, and disease management programs can influence which drugs are approved for the formulary.
6.	Describe the possible effects of an overly restrictive formulary.


    
    

Why Formularies

Introduction: This module discusses the rationale behind formularies and considers the advantages and disadvantages that come with their use.

Objectives:

1.	Explain the rationale for implementing a formulary.
2.	Identify advantages and disadvantages associated with formularies.


    
    

Overview of the 340B Drug Pricing Program

Introduction: This module will help you to understand the history of the program, how it is monitored, and recent changes that have occurred since the adoption of the Affordable Care Act (ACA). You also will learn how to determine the impact of the program in your market.

Objectives:

1.	Explain the history of the 340B program, and describe key terms and criteria related to the program.
2.	Describe how the 340B program is monitored.
3.	Explain how the ACA impacted growth of the 340B program and describe additional updates to the 340B program.
4.	Identify and describe challenges associated with oversight of the 340B program.
5.	Describe the impact of the 340B program on the pharmaceutical industry and identify resources for staying informed on a territory level.


    
    

Understanding MACRA and Its Impact on Physicians

Introduction: The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is radically changing how physicians receive payment from Medicare, the largest payer in the US. This module explains the most relevant aspects of MACRA and how they affect physicians. This module also describes value-based selling strategies in this changing environment.

Objectives:

1.	Understand the key goals of MACRA and how it transforms Medicare payment for physicians.
2.	Define the Merit-Based Incentive Payment System (MIPS).
3.	Describe advanced alternative payment models (APMs) under MACRA.
4.	Understand the strategies that physicians are using to be successful under MACRA.
5.	Identify opportunities for life science companies to deliver value to physicians during the MACRA transition.


    
    

The Oncology Care Model - Implications for Oncologists and the Industry

Introduction: The Centers for Medicare & Medicaid Services’ Oncology Care Model (OCM) is transforming how oncologists are paid for providing services to Medicare patients. This module explains the most relevant aspects of OCM and how they affect oncologists. This module also describes value-based selling strategies for life science companies in this changing environment.

Objectives:

1.	Understand the key goals of the Oncology Care Model and how it affects payment for physicians.
2.	Understand the strategies that will help physicians achieve success under the Oncology Care Model.
3.	Describe the implications for the life science industry and opportunities for sales professionals to deliver value to physicians participating in the Oncology Care Model.


    
    

A Profile of Management and Leadership

Introduction: This module clarifies the concepts of management and leadership. It discusses management and leadership characteristics and behaviors found in effective managers and provides an overview of the many roles that effective managers fulfill.

Objectives:

1. Explain how effective managers are also leaders and identify the benefits of effective management.
2. Characterize leadership and provide examples of when leadership is required.
3. Define and characterize a "systems approach" to management.
4. Describe the day-to-day work of managers and identify the roles they commonly fulfill.


    
    

How Leaders Create a Coaching Culture

Introduction: This module distinguishes these two important roles while focusing on how leaders can create a coaching culture.

Objectives:

1.	Explain the purpose of coaching and describe the steps involved in the process.
2.	Distinguish mentoring from coaching and describe how it helps to create leaders.


    
    

Decision Making as a Function of Leadership

Introduction: This module explores different approaches to decision making and considers the factors that influence the extent to which employees should be part of the decision-making process.

Objectives:

1.	Differentiate between prescriptive and descriptive approaches to decision making.
2.	Explain the continuum of employee involvement and the benefits of involving employees in decision making.
3.	Explain the Vroom-Jago model for managing employee involvement.
4.	Understand how biases can affect decision making.
5.	Explain how leaders use big data to make decisions.


    
    

Effective Communication for Leaders

Introduction: This module looks at how successful leaders promote an environment for effective communication and discusses specific avenues of communication, including business writing and e-mail, meetings, and presentations.

Objectives:

1.	Explain how leaders can promote effective communication through fostering a climate of communication and listening actively.
2.	Describe the effective use and purpose of business communication tools including memos and email.
3.	Explain how effective leaders prepare for, run, and follow up after meetings.
4.	Describe how leaders prepare and deliver effective presentations.


    
    

How Leaders Manage Teams

Introduction: This module discusses when teams are most useful and describes how they are developed and managed for maximum effectiveness.

Objectives:

1.	Explain when it is most useful to accomplish work through a team approach.
2.	Describe the Tuckman model of team development.
3.	Describe the steps effective leaders take to lead teams through the stages of development toward goal achievement.


    
    

How Leaders Optimize their Human Resources

Introduction: This module discusses how leaders make good hiring decisions and describes the ways in which they retain high performers, for example, through employee empowerment and effective delegation.

Objectives:

1.	Explain how effective leaders make good hiring decisions.
2.	Describe how leaders avoid high turnover and identify the resulting benefits.
3.	Explain how leaders successfully empower their teams and describe effective delegation as a form of empowerment.


    
    

How Leaders Solve Problems

Introduction: This module explores problem solving, which is a common task for leaders. It distinguishes formal from informal problem solving, looks at how groups can be used to solve problems, and considers how to successfully negotiate conflict when it occurs in the problem-solving process.

Objectives:

1.	Characterize common problems in the workplace.
2.	Describe types of problem solving including informal, formal, or in a group.
3.	Describe models for negotiating conflict and identify keys to effective win-win negotiations.


    
    

Self-Management for Leaders

Introduction: This module looks at the important skills of time and priority management, delegation, and stress management for leaders. It also explores how leaders can improve their effectiveness by learning from their experiences.

Objectives:

1.	Explain how effective leaders use time management and priority management to achieve their goals.
2.	Explain how delegating work can increase a leader’s productivity.
3.	Identify common causes of stress for leaders and suggest tips for managing stress.
4.	Explain how leaders can improve their effectiveness by learning from their experiences.


    
    

Project and Resource Management for Leaders

Introduction: This module discusses the steps that contribute to a productive planning process and looks at planning in the context of two important management skills—managing projects and managing resources.

Objectives:

1.	Explain the importance of planning and differentiate between long-range and strategic planning.
2.	Explain the general process of effective planning and implementation.
3.	Describe the phases of effective project management.
4.	Explain planning as a part of resource management and budgeting.


    
    

How Leaders Drive High Performance

Introduction: This module discusses how effective leaders build a culture of high performance by establishing productive relationships with employees, managing performance, measuring performance, and following up with appropriate actions.

Objectives:

1.	Explain how leaders build productive working relationships through trust, respect, and a willingness to learn from top performers.
2.	Describe important elements of performance management.
3.	Explain how effective leaders measure and track performance through goal setting, appraisals, and outcomes-based measurement.
4.	Identify the types of actions that may be appropriate based on performance outcomes.


    
    

Theories and Principles of Leadership

Introduction: This module discusses several leadership theories and the research that helps explain their underlying principles. The study findings support the notion that leaders can apply these principles to improve employee motivation and commitment.

Objectives:

1.	Summarize the general principles associated with leadership theories and explain how they have changed over time.
2.	Describe widely used leadership models and theories.
3.	Describe leadership concepts that are used to build and sustain leadership.


    
    

How Leaders Achieve a Diverse and Inclusive Workforce

Introduction: This module describes the benefits of a diverse workforce and explores how leaders can achieve a climate of diversity in their departments and functions. It also encourages leaders to pay close attention to the laws and regulations that help protect workers’ rights.

Objectives:

1.	Describe the benefits of diversity and how a high-functioning climate of diversity and inclusion can be created within a department or function.
2.	Explain how federal, state, and local regulations regarding discriminatory practices may impact leaders.


    
    

Communication Strategies: Targeting Providers

Introduction: The marketing department is responsible for developing and implementing effective marketing strategies for products and services, which are carried out in the marketplace by deploying a marketing mix of coordinated promotional and communications efforts. The marketing mix—and how its elements are marshalled and coordinated—is laid out in the marketing plan. Based on the plan’s research and situational analysis, the department sets objectives, and establishes a strategy, including the tactical decisions of how best to use the marketing mix elements. This module describes those elements of the marketing mix that are designed to reach and persuade prescriber/provider target markets.

Objectives:

1. Explain how marketing mix elements are strategically coordinated to create a unified marketing campaign.
2. Explain how today’s sales presentations use tools such as sampling and e-detailing to meet the informational needs and schedules of providers.
3. Describe other marketing mix elements that target providers—including journal ads and reprints and education programs.


    
    

Evolution of Biopharmaceutical Marketing

Introduction: This module discusses the shift in product development drivers from purely professional and academic concerns to commercial forces, and how that has increased the importance of marketing.

Objectives:

1.	Describe the circumstances leading to the birth of the biopharmaceutical marketplace in the late 19th century.
2.	Describe the key developments of the first half of the 20th century that affected the potential profitability of biopharmaceutical products.
3.	Explain how a slowdown in new product introductions helped increase the role of marketing in the biopharmaceutical industry in the 1960s.
4.	Explain how rational product design and increased competition helped shape the biopharmaceutical industry in the 1970s.
5.	Describe the impact of blockbuster products in the late 1970s and early 1980s.
6.	Explain how events and trends of the late 20th century set the stage for 21st century developments. 
7.	Explain how economic, legislative, and technological events changed the roles of physicians, patients, and manufacturers in the 21st century.


    
    

Market Research in the Life Science Industry

Introduction: This module discusses types of research methods and data and the various applications of market research.

Objectives:

1.	Describe the differences between secondary and primary market research.
2.	Describe the differences between qualitative and quantitative market research.
3.	Explain the various applications of market research.


    
    

Regulations Governing Life Science Marketing

Introduction: This module discusses how advertising and promotional materials are regulated by the US and by international associations. Regulations and self-regulatory guidelines within the United States and abroad are then described.

Objectives:

1.	Describe the need for regulation in life science advertising and promotion.
2.	Explain the regulatory system governing biopharmaceutical advertising and promotion in the United States.
3.	Describe the international regulations that affect biopharmaceutical advertising and promotion.
4.	Describe trade association guidelines, including life science industry self-regulatory efforts.


    
    

The Marketing Department Staff and Environment

Introduction: This module discusses the types of personnel involved in marketing activities, their positions within the marketing organization, and the type of environment that enables them to work most effectively.

Objectives:

1.	List the types and functions of key in-house marketing managers, and how they are positioned within marketing organizations.
2.	Describe the personnel and agencies who perform support functions for the marketing department.
3.	Describe the learning environment that characterizes the marketing department.


    
    

The Role of Marketing across the Product Life Cycle

Introduction: This module describes the role of the life science marketing department, the unique challenges it faces, and the key instruments it uses to carry out its mission across the product lifecycle—notably the marketing plan, marketing strategy, and marketing mix. The module also describes the stages of the product lifecycle and the forces that affect a product’s movement through the various stages.

Objectives:

1.	Describe the role and unique challenges of the life science marketing department.
2.	Describe the role of the marketing plan and its key components, including marketing strategy and marketing mix.
3.	Explain the transition to the SAVE marketing mix model and describe its key components.
4.	Explain the marketing lifecycle of pharmaceutical products.


    
    

Trends in Life Science Marketing

Introduction: This module describes current trends in life science marketing, which include direct-to-consumer advertising, use of the Internet, the application of pharmacoeconomic data, and copromotion agreements.

Objectives:

1.	Describe the latest trends in direct-to-consumer advertising and how such advertising affects patient/physician relationships.
2.	Explain the evolving role of the Internet in marketing.
3.	Explain the applications of pharmacoeconomic data in marketing.
4.	Explain how copromotion agreements can have an impact on marketing departments.


    
    

Marketing to the New Managed Care Marketplace

Introduction: This module addresses the marketing shifts that occur in response to an evolving managed care marketplace, driven by legislation, new decision-makers, disease management programs, research, and technology.

Objectives:

1.	Describe the impact of managed care changes on the healthcare marketplace.
2.	Describe the impact of recent healthcare legislation on managed care and on life science marketing.
3.	List the stakeholders in the purchasing decision-making process and explain their roles.
4.	Describe disease management programs and their role in healthcare marketing.
5.	Explain the role of decision-support technologies in managed care and life science marketing.


    
    

Cost-Containment Strategies in Managed Healthcare

Introduction: This module describes cost-containment strategies developed by managed care organizations (MCOs) to reduce the unnecessary use of healthcare resources and associated costs.

Objectives:

1.	Describe the role of care management in controlling healthcare costs.
2.	Describe how value-based payment arrangements are making providers more attentive to costs.
3.	Describe how benefit design contributes to cost control.
4.	Describe the various drug management strategies being used to help control drug costs.
5.	Describe the functions performed by pharmacy benefit management companies (PBMs).
6.	Describe a total systems approach to healthcare in relation to reducing total costs of care.


    
    

Evaluating and Improving the Quality of Managed Care

Introduction: This module highlights some of the key organizations and approaches being used to evaluate and improve the quality of care in MCOs, including: • The Institute for Healthcare Improvement’s Triple Aim • Federal quality-related initiatives • Accrediting organizations, including The National Committee for Quality Assurance (NCQA) and the Joint Commission • Performance measurement and transparency • Clinical guidelines

Objectives:

1.	List the three goals of the Triple Aim.
2.	Characterize the value-related initiatives being deployed on the federal level to meet the National Quality Strategy.
3.	Describe accreditation, certification, and recognition programs.
4.	Define how performance measurement is being used to improve and draw attention to quality.
5.	Define evidence-based care and how clinical practice guidelines contribute to evidence-based care.


    
    

How Trends and Forces in Managed Care are Impacting the Pharmaceutical Industry

Introduction: This module discusses four major managed care trends that are influencing the pharmaceutical industry: 1. A growing focus on outcomes research and management fueled, in part, by concerns over costs/value. 2. Increased use of clinical practice guidelines, disease management programs, evidence-based medicine, and personalized medicine. 3. New contractual relationships. 4. New business-oriented decision makers and a consumer-focused market.

Objectives:

1.	Explain how the pharmaceutical industry is adapting to the growing focus on outcomes research and management.
2.	Describe the impact of clinical practice guidelines, disease management, evidence-based medicine, and personalized medicine on the role of the pharmaceutical industry.
3.	Describe the new contractual relationships being implemented among pharmaceutical companies and their managed care customers.
4.	Describe the various decision makers that influence drug purchasing and utilization in healthcare organizations, and the implications of a consumer-focused market.


    
    

An Overview and History of Managed Healthcare

Introduction: This module provides an overview of healthcare costs and quality, as well as the tools, approaches, and financial incentives used in managed care to improve value. The module also gives a brief history of managed care, including relevant federal legislation and describes various types of managed care plans and organizations.

Objectives:

1.	List the factors influencing healthcare costs and quality.
2.	Describe how managed care approaches, incentives, and tools are used to control healthcare costs and improve clinical quality and the care experience.
3.	Describe key historical developments and important federal legislation that spurred the growth of managed care.
4.	List and describe different types of managed care organizations and plans.


    
    

Disease Management as a Component of Managed Care

Introduction: This module discusses the key elements of disease management systems and explores how disease management programs are evaluated.

Objectives:

1.	Explain key elements of disease management systems (population demographics, clinical practice guidelines, implementation techniques, patient data monitoring, and outcomes assessment).
2.	Describe how disease management programs are evaluated and identify some keys to the success of disease management programs.
3.	Identify how population health management differs from disease management.


    
    

Hospitals and Post-Acute Providers in the Managed Care Environment

Introduction: This module discusses the changing role of acute care hospitals and the growing role of post-acute providers, especially home care, hospice, and skilled nursing facilities.

Objectives:

1.	Describe current trends in managed care which are changing the role of acute and post-acute providers.
2.	Identify the various types of acute care hospitals and characterize how hospitals are organized.
3.	Describe long-term care facilities.
4.	Characterize home healthcare and hospice.


    
    

Information Technology in Managed Healthcare

Introduction: This module describes the various functions and capabilities of health IT while highlighting some of the remaining challenges and obstacles.

Objectives:

1.	Describe specific types of health IT, including electronic health records (EHRs), e-prescribing, portals, data storage and analysis, and health information exchange.
2.	Explain the ways IT can be leveraged to achieve the goals of managed care.
3.	Characterize the IT challenges that the industry is facing, including patient rights under HIPAA, interoperability, provider-patient communication issues, usability, patient confidentiality, and security.


    
    

Integrated Delivery Networks and Accountable Care Organizations

Introduction: This module focuses on the increased integration and consolidation occurring among provider organizations and insurers. As described in this module, integrated delivery networks (IDNs), sometimes referred to as integrated delivery systems or provider networks, come in all different shapes and sizes, and they are formed through various types of formal legal structures as well as informal partnerships. This module will compare IDNs to Accountable Care Organizations (ACOs). It describes the features of these models.

Objectives:

1.	Explain why providers and some health plans are integrating.
2.	Identify distinguishing features of IDNs, including horizontal versus vertical integration, insuring and non-insuring IDNs, virtual versus full integration, functional versus physician versus clinical integration, and regional versus national.
3.	List and describe key elements of integrated delivery networks.
4.	Describe the characteristics of the most common IDN models.
5.	Define and characterize accountable care organizations.


    
    

Managed Care and the Expanding Care Team

Introduction: This module looks at the trends in managed care that affect and influence physicians, as well as the evolving and expanding care team, which includes nurse practitioners, physician assistants, pharmacists, and case managers.

Objectives:

1.	Characterize how trends in managed care are changing the roles of primary care physicians and specialists.
2.	Describe the expanding and evolving care team, including the roles of nurse practitioners, physician assistants, pharmacists, and case managers in managed care organizations.


    
    

Major Healthcare Payers and Managed Care Payment

Introduction: This module provides an overview of the major payers and payment arrangements. As payers continue to try and contain healthcare costs, they are shifting from traditional indemnity or fee-for-service payment arrangements with providers to various risk-based arrangements, including capitation, bundled payment, and shared savings. Many of these arrangements—which are sometimes called value-based payment—also incentivize providers to improve clinical quality and the patient experience.

Objectives:

1.	Characterize the complexity of the healthcare payment system and the evolution to value-based payment that is occurring in the industry.
2.	Identify common types of fee-for-service and value-based payment arrangements.
3.	Characterize how providers are reimbursed for drugs.
4.	Describe how the major payers—Medicare, Medicaid, commercial health plans, and employers—are using managed care approaches.


    
    

The Managed Care Pharmacy

Introduction: This module discusses current strategies for managing pharmacy coverage, the changing role of the pharmacist, and the role of pharmacy benefit management (PBM) companies.

Objectives:

1.	Describe current methods for managing formularies and pharmacy coverage.
2.	Describe how the role of the pharmacist is changing.
3.	Describe the pharmacy benefit services frequently offered by PBMs and the role of specialty pharmacies.


    
    

Opportunities for Representatives in Managed Healthcare

Introduction: This module describes the emergence of managed care divisions in many pharmaceutical companies and the implications it has for field sales. The module also discusses several aspects of a representatives’ job that are critical to success in today’s marketplace.

Objectives:

1.	Describe the trend by pharmaceutical companies to create managed care divisions and the implications it has for the field sales force.
2.	Describe the changing focus of the healthcare representative and the types of skills that will help a representative succeed in today's healthcare environment.


    
    

Creating Business Presentations that Make an Impact

Introduction: This module begins with a description of the advantages and disadvantages of presentations and when they should be the communication tool of choice. It then discusses the process of making a business presentation, including planning, organizing, selecting visual aids, and delivering the presentation.

Objectives:

1.	Describe the advantages and disadvantages of business presentations.
2.	Describe the steps involved in planning an effective presentation.
3.	Explain how to effectively organize a business presentation.
4.	State the purposes of visual aids and describe the various types.
5.	Describe how to effectively deliver a business presentation.
6.	Discuss considerations for making webinar presentations successful.


    
    

Managing by Communicating

Introduction: This module focuses on the advantages of good communication and common communication problems in business.

Objectives:

1.	Identify potential positive outcomes related to the development of effective communication skills.
2.	Identify common communication problems that exist in business.


    
    

Communicating with a Diverse Workforce

Introduction: This module focuses on workplace diversity—differences arising from influences such as culture, gender, age, socioeconomic status, cognitive styles and physical and mental abilities. It offers tools for better understanding the nature of such differences and describes the issues managers face in improving communication in a diverse workforce. It also explains how communication that is sensitive to diversity can enhance an organization’s ability to work effectively in a global market.

Objectives:

1.	Define workplace diversity and describe the key challenges and opportunities it presents to a global organization.
2.	Define culture in terms of its dimensions and layers and explain how these affect communication in a culturally diverse organization.
3.	Explain how demographic differences such as gender, age, and socioeconomic status require different communications approaches for different employees.
4.	Describe how effective managers take different cognitive and learning styles into consideration in communicating with employees, colleagues, and representatives from other organizations.


    
    

The Role of Accountable Care Organizations in Healthcare Delivery

Introduction: This module covers the establishment of accountable care organizations and explores their potential impact on biopharmaceutical and device companies.

Objectives:

1.	Define the term accountable care organization (ACO), describe its basic features, and examine its evolution to date.
2.	Explain how ACOs differ from integrated delivery networks (IDNs) and managed care organizations (MCOs).
3.	Describe how ACOs measure quality and share savings and risk.
4.	Examine the implications of ACOs for biopharmaceutical and device companies.
5.	Describe other coordinated care approaches being piloted in the healthcare system.


    
    

Measuring the Patient Experience: The Connection to Quality

Introduction: This module describes how providers are measuring and trying to improve the patient experience. Healthcare sales professionals will gain insight into how they can support their customers in these efforts.

Objectives:

1.	Describe the benefits of a positive patient experience for providers and their patients.
2.	Explain how the Triple Aim and value-based payment models are driving provider interest in improving the patient experience.
3.	Explain the most common methods used in the US to measure the patient experience.
4.	Discuss strategies that providers are using to improve the patient experience.
5.	Identify opportunities for life science companies to help improve the patient experience.


    
    

Selling in a Hospital Environment

Introduction: As healthcare delivery in hospitals continues to adapt to rapid market changes, the approach to selling in hospitals must also adapt. You already know the driving forces, an emphasis on cost and outcomes, coordinated patient care, value-based payment models, financial penalties, "meaningful use" EHRs, and population health management (PHM), to name a few. This module explores today's hospital environment and what it means for selling life-science products and services. Throughout, you will be asked to consider the impact to your own accounts.

Objectives:

1. Explain how hospital selling is influenced by the emphasis on coordinated care, the care continuum, and changing models of reimbursement.
2. Characterize the basic structure of a hospital and identify the various departments commonly found in hospitals.
3. Distinguish between the different titles and roles one might encounter among physicians and nurses in a hospital setting.
4. Describe important steps you can take to maximize your success when selling in a hospital environment.


    
    

The Affordable Care Act and Its Implications for the Life Science Industry

Introduction: This module looks at the main aspects of healthcare reform set forth by the ACA, including expanding access to insurance coverage, closing the Medicare Part D coverage gap, and improving transparency between the industry and physicians. The module also explores the implications of these reforms for the life science industry.

Objectives:

1.	Define the Affordable Care Act (ACA) and describe its key goals.
2.	Explain key provisions of healthcare reform under the ACA.
3.	Discuss possible implications of healthcare reform for the life science industry.


    
    

The Health Insurance Marketplace

Introduction: This module looks at the main features of the market and how state health insurance exchanges are evolving amid political uncertainty. The module also explores the implications of exchanges for various stakeholders, including life science companies.

Objectives:

1.	Describe the basic features of health insurance exchanges and how and why they are evolving as a result of healthcare reform.
2.	Examine the implications of health insurance exchanges for patients, health plans, employers, providers, and life science companies.


    
    

Today's Medical Groups and the Transition to Value-Based Care

Introduction: This module discusses the trends affecting medical groups and how life science companies can build more meaningful partnerships with these important customers to help protect market access.

Objectives:

1.	Understand how consolidation and integration are affecting medical groups.
2.	Explain how the role of medical groups is evolving as more care shifts from inpatient to outpatient settings.
3.	Describe emerging factors affecting physician compensation, including the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
4.	Understand how medical practices are using health IT, clinical pathways, and other tools for population health management.
5.	Identify opportunities for life science companies to offer more value to medical groups as payment models evolve.


    
    

Value-Based Care and the Changing Healthcare Delivery Model

Introduction: This module discusses different types of value-based payment and how providers are preparing for the transition from fee-for-service medicine to value-based care. Healthcare sales professionals will gain insight into how they can be valued partners by offering products and services that support their customers’ focus on value.

Objectives:

1.	Define the concept of value in healthcare and how it relates to the Triple Aim.
2.	Describe the key goals of value-based care, including reducing practice variation, controlling costs, and enhancing quality.
3.	Explain different types of value-based payment.
4.	Discuss strategies that providers are using to prepare for the shift to value-based care.
5.	Identify opportunities for the industry in a value-based care environment.


    
    

EHRs and Health Information Technology: Opportunities for Sales and Marketing

Introduction: This module looks at how legislation set the wheels in motion. It explores how the use of HIT is being fueled by the adoption of “meaningful use” (now known as “promoting interoperability”) certified electronic health records (EHRs) and discusses the challenges associated with implementing EHRs. This module also clarifies the difference between EHRs and electronic medical records (EMRs), which arrived on the scene in many clinical practices before the nationwide commitment to EHRs.

Objectives:

1.	Describe how legislation has urged the development of health information exchange (HIE) and identify the benefits.
2.	Explain the purpose and focus of the “Promoting Interoperability” program (formerly the “Meaningful Use” program).
3.	Distinguish between electronic medical records (EMRs) and electronic health records (EHRs).
4.	Characterize the challenges associated with implementing EHRs.
5.	Discuss the potential opportunities associated with EHRs for the biopharmaceutical and medical device industries.


    
    

Population Health Management: A Strategy for Higher Quality and Lower Costs

Introduction: This module outlines current approaches to population health management, including patient-centered medical homes (PCMHs), perioperative surgical homes (PSHs), and accountable care organizations (ACOs). The module also discusses the implications of population health management for biopharmaceutical and device companies.

Objectives:

1.	Define population health and identify the factors that can influence population health.
2.	Discuss the key reasons providers and payers are interested in population health.
3.	Describe the main components of population health management.
4.	Describe approaches to population health management, such as patient-centered medical homes (PCMHs), perioperative surgical homes (PSHs), and accountable care organizations (ACOs).
5.	Examine the implications of population health management for biopharmaceutical and device companies.



    
    

Strategies for Effective Account Management

Introduction: This module explores the activities that are essential to effective account management.

Objectives:

1.	Describe the roles and competencies of account managers.
2.	Discuss the major issues influencing product-related decisions for health plans, pharmacy benefit managers (PBMs), health systems, and ACOs.
3.	Explain the strategies these accounts use to control pharmaceutical costs.
4.	Identify the key decision makers in these accounts and anticipate their various perspectives.
5.	Examine an account management process that will set the stage for success.
6.	Identify various approaches account managers can use to build relationships through value-based collaborations.


    
    

Understanding ICD-10

Introduction: In October of 2015, US healthcare providers and other industry stakeholders, such as health plans, began using the ICD-10 code sets to report medical diagnoses and inpatient procedures. This module helps you understand ICD-10 and how it impacts your customers.

Objectives:

1.	Describe ICD-10 and discuss the benefits of the conversion from ICD-9 to ICD-10.
2.	Discuss the challenges providers faced during the transition to ICD-10.
3.	Identify the implications of ICD-10 for healthcare sales professionals.


    
    

Cost and Resource Utilization Analyses

Introduction: This module discusses how healthcare organizations are using cost and resource utilization analyses to improve efficiency.

Objectives:

1.	Explain how healthcare organizations use cost and resource utilization analyses to help evaluate economic outcomes and differentiate among common compensation methods/cost categories.


    
    

Evolution of the Outcomes Movement

Introduction: This module describes the evolution of today’s outcomes movement in healthcare, including key milestones in its development, and key ways in which researchers and organizations have used outcomes measurement to help establish standards for quality delivery of healthcare.

Objectives:

1.	Describe key milestones in the development of the outcomes movement.
2.	Describe how outcomes research has been used to reduce variation in clinical practice.
3.	Describe the role of outcomes research in helping to maintain or improve the quality of healthcare.


    
    

Focus of Outcomes Management

Introduction: This module begins with a discussion of the various ways that healthcare organizations are attempting to manage clinical, economic, and humanistic outcomes. It then discusses the roles of stakeholders in outcomes management..

Objectives:

1.	Describe the various types of outcomes management programs that can be implemented by healthcare organizations.
2.	Characterize the roles of stakeholders involved in the field of outcomes management.


    
    

Forces Shaping Today's Outcomes Movement

Introduction: This module will look at forces shaping the 21st century outcomes movement, particularly from the perspectives of healthcare delivery organizations, patients, and payers (including Medicare and Medicaid, the nation’s largest payers).

Objectives:

1.	Explain how outcomes research has helped healthcare delivery organizations achieve strategic goals.
2.	Describe the evolving role of the federal government in outcomes research, measurement, and management.
3.	Explain how developments in health information technology have impacted outcomes research, measurement, and management.


    
    

Health Plan Accreditation and Related Performance Measures

Introduction: This module describes the primary organizations involved in the accreditation (and accreditation-related performance measures) of health plans, which include: • The Joint Commission. • The National Committee for Quality Assurance (NCQA). • URAC. • The National Alliance of Healthcare Purchaser Coalitions. It also describes the role of the Healthcare Effectiveness Data and Information Set (HEDIS®) in quality programs and the impact it is having on healthcare organizations.

Objectives:

1.	Discuss the key characteristics of the primary organizations involved in the accreditation of health plans.
2.	Explain the role of HEDIS in measuring the outcomes of healthcare organizations.
3.	Describe the relationship between CMS quality measures and the efforts of accrediting organizations.


    
    

Health-Related Quality of Life (HRQOL) Measures

Introduction: This module describes the components of HRQOL measures and the use of instruments for measuring general health status, as well as disease-specific instruments. The module concludes with examples of how HRQOL data are being gathered and applied within healthcare organizations.

Objectives:

1.	Identify common dimensions of health-related quality of life measures.
2.	Differentiate between the uses of general health status instruments and disease-specific instruments.
3.	Discuss the scoring systems for the three types of health-related quality of life instruments—health profile, health index, and health battery.
4.	Explain how health-related quality of life data can benefit healthcare organizations.


    
    

Pharmacoeconomic Analyses

Introduction: This module describes the five major types of pharmacoeconomic analyses: • Cost-minimization. • Cost-consequence. • Cost-benefit. • Cost-effectiveness. • Cost-utility. The module also discusses the importance of identifying the perspective of pharmacoeconomic analyses.

Objectives:

1.	Discuss the most common types of pharmacoeconomic analyses and explain their applications.


    
    

Role of Outcomes in Clinical Practice Guidelines and Disease Management

Introduction: This module provides an overview of how clinical practice guidelines are developed and implemented. It also discusses the key elements of disease management, including outcomes assessments.

Objectives:

1.	Describe the issues involved in the development and implementation of clinical practice guidelines.
2.	Describe the key elements of disease management plans.


    
    

Role of Structure, Process, and Outcomes in Quality Management

Introduction: This module discusses how structure, process, and outcomes are interrelated in quality management. It also discusses the role of the ECHO model in outcomes research.

Objectives:

1.	Explain the roles of structure, process, and outcomes in quality management.
2.	Explain how the ECHO model is used in outcomes research.


    
    

Stakeholder Perspectives on Outcomes

Introduction: This module discusses the perspectives of stakeholders in outcomes research and management.

Objectives:

1.	Characterize the varying perspectives on outcomes of different stakeholders, including healthcare providers, patients, third-party payers, hospitals, and healthcare delivery organizations.


    
    

The Life Science Industry and Outcomes Management

Introduction: This module discusses how life science companies are collaborating with managed care and integrated care customers and pharmacy benefit managers (PBMs) to participate in outcomes research and management. It also describes the role of key decision-makers within healthcare organizations who are interested in outcomes management.

Objectives:

1.	Explain the benefits that life science companies can offer to healthcare organizations interested in outcomes management.
2.	Explain potential roles of life science companies, PBMs, ACOs, and MCOs in outcomes management.
3.	Discuss the various types of financial arrangements that life science companies and PBMs may offer healthcare organizations interested in outcomes management.
4.	Characterize the key decision-makers in healthcare organizations who are likely to have an interest in outcomes management.


    
    

The Role of the Field Sales Team in Outcomes Management

Introduction: This module discusses how healthcare sales professionals can help meet the outcomes management needs of their customers.

Objectives:

1.	Explain how the field sales team can help healthcare organizations identify their outcomes management needs and coordinate these programs.
2.	Explain how healthcare sales professionals and account managers can help build relationships with employers interested in implementing outcomes management programs.
3.	Identify the skills that would benefit healthcare sales professionals or account managers interested in participating in the outcomes management efforts of their company.


    
    

Understanding the Basics of Risk Contracting

Introduction: This module discusses the basics of risk contracting as more life science companies consider this strategy to build more meaningful partnerships with their customers.

Objectives:

1.	Understand common concepts in risk and risk sharing.
2.	Identify the key factors driving the shift to risk sharing across the healthcare industry.
3.	Describe several examples of risk-based arrangements in the healthcare industry today.
4.	Understand the nature of risk and how it applies to the insurance business.
5.	Identify opportunities for life science companies participating in risk contracts with payers and providers.


    
    

Project Management Tools

Introduction: This module describes various tools that are available to help you manage groups of tasks involved in your project. You can select those that intuitively feel most helpful to you and appropriate to the project. There is no right or wrong choice.

Objectives:

1. Distinguish among basic tools used for various project management tasks.2. Recognize when more sophisticated project management tools may be helpful.


    
    

Tools for Economic Evaluation

Introduction: The tools discussed in this module make sense of data, provide theoretical constraints within a given set of assumptions or parameters, and provide a sense of order and certainty through mathematical and analytical processes. However, their predictability must be balanced against a broad understanding and perspective of the economic issue or problem being considered, and allowance must be made for unintended consequences.

Objectives:

1. Describe how return-on-investment (ROI) analysis is used in the healthcare setting.
2. Distinguish between net present value (NPV) and economic value added as forms of economic analysis.
3. Describe common methods of pharmacoeconomic analysis.


    
    

Generic Competition and Over-the-Counter Drugs

Introduction: In this module, we will review the impact of generic drugs on the pharmaceutical industry, and then describe some of the strategies companies are adopting to offset the impact of this competition, including transfer of drugs to over-the-counter status.

Objectives:

1.	Describe the impact of generic drugs on brand-name prescription drug sales.
2.	Explain the strategies pharmaceutical companies may adopt to offset generic competition.
3.	Explain the rationale for switching a prescription drug to an over-the-counter product.


    
    

Pharmaceutical Prices: Balancing Innovation with Access and Affordability

Introduction: The pharmaceutical industry’s innovative products have transformed lives while generating strong financial returns for companies and investors. Yet in today’s value-conscious environment, pharmaceutical prices are frequently under scrutiny. This module begins by discussing the importance of industry profitability. The discussion will then provide an overview of current trends in prescription drug spending. The module will also cover issues related to access and affordability as companies aim to demonstrate the value of their drugs.

Objectives:

1.	Explain why it is important for pharmaceutical companies to be profitable.
2.	Describe current and future trends affecting drug pricing.
3.	Explain the impact that advertising has on drug prices.
4.	Describe factors that contribute to increased spending on pharmaceuticals and how patient assistance programs can reduce patient costs.
5.	Explain the current status of private and government insurance coverage for pharmaceutical products.
6.	Describe the arguments for and against price controls as a means of achieving affordable prescription drug prices.


    
    

Advances and Innovations in Medications

Introduction: This module describes the role of medications, particularly new drugs, in saving and extending patients' lives, as well as improving their quality of life.

Objectives:

1.	Describe how medications, as compared to general medical care, help increase life expectancy.
2.	Describe the ways in which medications help to improve quality of life for patients.


    
    

Factors Influencing Prescription Drug Pricing

Introduction: To understand the rationale for pricing prescription drugs, it is necessary to appreciate the new expanded role for pharmaceuticals. Thus, this module begins with a discussion of the price of prescription medications in overall healthcare costs. This is followed by a description of the factors involved in setting drug prices.

Objectives:

1.	Explain how the price of pharmaceuticals compares to overall healthcare costs.
2.	Describe the costs involved in researching and developing a new drug.
3.	Describe the factors that contribute to the costs of prescription drugs, including discounts, competition, patient issues, liability, value-added services, drug shortages, corporate philanthropy, and orphan drug status.
4.	Identify the phases of a drug's marketing life cycle and explain how each phase can influence drug pricing.


    
    

Overview of Pharmaceutical Drug Patents

Introduction: This module describes pharmaceutical drug patents and discusses the impact of patent expiration on the sales and price of a drug.

Objectives:

1.	Define a patent and describe the criteria for obtaining one.
2.	State the typical patent life of a prescription drug.


    
    

Pharmacoeconomic Outcomes

Introduction: This module discusses how the application of pharmacoeconomics can demonstrate the value of prescription drugs. It also discusses the role of the ECHO model in pharmacoeconomic outcomes research.

Objectives:

1.	Explain the role of pharmacoeconomic studies in demonstrating the value of prescription drugs.
2.	Describe the ECHO model of outcomes and give examples of how pharmaceuticals have improved economic, clinical, and humanistic outcomes.


    
    

The Role of Pharmaceutical Companies In Determining Price and Value

Introduction: This module discusses some of the reasons why the value of a drug may not be attained and describes what pharmaceutical companies can do to help ensure that the value of their drugs is achieved as well as government mandated actions intended to improve health outcomes which most experts feel will lead to a reduction in healthcare spending. It then discusses the ways in which pharmaceutical companies can illustrate the value of prescription drugs to their customers.

Objectives:

1.	List the reasons why the value of a prescription drug may not be realized.
2.	Describe what pharmaceutical companies can do to help ensure that the value of their drugs is achieved.
3.	Describe how patient-centered outcomes research can play a role in containing healthcare costs while providing better health outcomes.
4.	Describe the methods that pharmaceutical companies can use to demonstrate the value of prescription drugs to physicians.


    
    

The Cost of Specialty Drugs

Introduction: The cost of specialty drugs has come under scrutiny from payers, providers, and the public. To address these concerns, you first need to understand what contributes to the cost—and how that cost is managed. This module describes some of the key issues, including: • The factors that contribute to higher specialty drug costs. • How payers manage these costs. • The implications for sales teams.

Objectives:

1.	Identify critical issues concerning the high cost of specialty drugs.
2.	Identify industry cost containment strategies and explain why they are difficult to employ successfully in the specialty market.
3.	Describe the kinds of questions professional sales teams need to be able to answer to succeed in the specialty marketplace.


    
    

Understanding Buy and Bill

Introduction: This micro-course outlines five quick facts you should know about drug distribution and the reimbursement model, offering a foundational understanding of the Buy-and-Bill model.

Objectives:

1. Explain that a specialty drug can be reimbursed as a medical benefit through the buy-and-bill model or as a pharmacy benefit.
2. Describe the key roles of providers and distributors in the buy-and-bill model.
3. Explain the workarounds some health plans have developed with specialty pharmacies to reimburse provider-administered specialty drugs under the pharmacy benefit, rather than through the buy-and-bill model.
4. Describe what type of organizations the buy-and-bill model appeals to.
5. Explain how the buy-and-bill model is becoming less common as more payers choose to use specialty pharmacies and reimburse drugs under the pharmacy benefit.


    
    

Communication Strategies: Targeting Patients and Multiple Audiences

Introduction: The marketing department is responsible for developing and implementing effective marketing strategies for products and services, which are carried out in the marketplace by deploying a marketing mix of coordinated promotional and communications efforts. The marketing mix—and how its elements are marshalled and coordinated—is laid out in the marketing plan. This module describes those marketing mix elements designed to reach and persuade patient/consumer target markets and those that target both patients and providers.

Objectives:

1.	Explain how marketing mix elements are strategically coordinated to create a unified marketing campaign.
2.	Describe the marketing mix elements that target patients/consumers, collectively known as DTC advertising.
3.	Describe the marketing mix elements that target both patients and providers, including direct mail, web-based and social media channels.