HEALTHCARE COMPLIANCE 2 – DISCUSSION – 1 PARAGRAPH Are fines enough? As dramatic as the $3 billion fine appears for GlaxoSmithKline, there are some who bel

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Are fines enough? As dramatic as the $3 billion fine appears for GlaxoSmithKline, there are some who believe it was not enough. There are those who advocate making the consequences of misconduct harsh leading to possible jail time and that the GSK executives should have been summarily dismissed. What are your thoughts?






Chapter 23

Pharmaceutical Manufacturers

Learning Objectives

Familiarity with largest drug companies and their record of fraud violations

7 elements of a mandatory compliance program

Role of the Compliance Officer

Purpose of policies and procedures on compliance

Areas of greatest drug company fraud risk

Analyze compliance program effectiveness

Questions & complaints about compliance


Drugs constitute 10% of health care spending

Reasons for continued growth in expenditures on drugs

Few factors slowing that growth

Pharmaceutical Manufacturers & Their Fraud Violation Records

Pharmaceutical industry composed of a few very large, highly competitive companies

Top 10 pharmaceutical companies based on their revenues in 2010 and 2011

Largest federal fraud settlements with pharmaceutical companies in last five years

Active Corporate Integrity Agreements with pharmaceutical companies in early-2013

Seven Elements of Effective Compliance

Implementing written policies and procedures

Designating a Compliance Officer and Committee

Conducting effective training and education

Developing effective lines of communication

Conducting internal monitoring and auditing

Enforcing standards through disciplinary guidelines

Responding to problems & taking corrective action

Designating a Compliance Officer and Compliance Committee

Compliance Officer – focal point for compliance activities, full-time, sufficient authority, staff & resources, direct access to CEO and BOD

OIG-prescribed responsibilities of the CO

Compliance Committee – advise and assist the CO, understand company operations, integrity, judgment, assertiveness, and accessibility

Written Policies and Procedures

Code of Conduct – fundamental principles and values to provide overall direction to employee work behavior

Policies and procedures – governing employee actions in areas of operations where there is the highest risk of potential liability under federal fraud and abuse laws

Risk areas defined by OIG Program Guidance for Pharmaceutical Manufacturers


Integrity of Data Used to Determine Government Reimbursement

Many federal and state health care programs base their reimbursement rates for drugs on price and sales data submitted by drug firms

Failure to submit high integrity data exposes a company to liability under the False Claims Act, the Civil Monetary Penalties Statute, and the Anti-Kickback Statute

Prices reported must reflect any adjustments made to prices charged to purchasers

Kickbacks and Other Illegal Remuneration

Violations of the Anti-Kickback Statute (AKS) may result in criminal penalties

Identify paying relationships with persons able to generate federal health care revenues for the company

Examine reasons for each of the relationships

Criteria for judging legal risk of a relationship

Modify the relationship or fit it into one of the “safe harbors”

Risky Relationships:
Purchasers and Their Agents

Discounts and other remuneration to purchasers

Product support services

Educational grants

Research funding

Risky Relationships: Persons Able to Make or Influence Referrals

Physicians are the best example – anything of value given to them is prohibited

Best protection is an AKS safe harbor

Otherwise, factors to be considered

PhRMA Code on Interactions with Healthcare Professionals

Its guidelines

High-risk manufacturer-physician relationships

Risky Relationships: Agents

Most drug company compliance problems start with sales and marketing personnel

Compliance training for marketing people

Educate about minimum PhRMA Code standards

Corrective action for misbehaving sales agents

Monitor sales force activities

Special issue – compensation for sales agents

Conducting Effective
Training and Education

Teach employees to follow compliance-friendly policies & procedures in performing their jobs

Topics to be covered


Required participation

Frequency of training

Condition of employment

Developing Effective Lines of Communication

Employees must have effective ways of asking questions about compliance, and reporting incidents that may violate compliance procedures and fraud & abuse laws.

Communication channels offering anonymity and freedom from retaliation, well-publicized

Typical channel media, including periodic surveys

Auditing and Monitoring

Watch over the functioning of the company’s compliance program, assess its effectiveness, and make recommendations for improvement

Regular monitoring of program operations

Periodic audits of its activities and the results they produce

Prospective and retrospective reviews

Topics to focus on

Enforcing Standards Through Well-Publicized Disciplinary Guidelines

Enforced against employees who fail to follow compliance policies and procedures

The level of discipline will depend on the severity of the employee’s misconduct

Discipline could range from oral or written warnings, through suspension, up to dismissal.

Responding to Detected Problems & Developing Corrective Action

Launch an immediate investigation

Violation of law or compliance program rules

Decisive steps to correct any problem

Report legal violations to government authorities – may mitigate any penalties

Review of a Typical Pharmaceutical Manufacturer Compliance Program

Compare the language in a typical drug company compliance program with recommendations made in this chapter and in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers.

In what ways is it better than the recommendations, and in what areas could it stand to be improved

Questions ???

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