Chapter 1

Question 1

What is the focus of a Compliance Program

Answer 1

following rules and regulations

Question 2

What is the focus of an Integrity Program?

Answer 2

values and doing the right thing

Question 3

Compliance activities already occurring

Answer 3

(EEOC) Equal Employment Opportunity Commission
(ERISA) Employee Retirement Income Security Act
Department of Labor wage and hour rule
(OSHA) Occupational Safety and Health Organization
Nuclear Regulatory Commission Requirements
Joint Commission
(AAAASF) American Association for Accreditation of Ambulatory Surgery Facilities

Question 4

What is a Compliance Program?

Answer 4

-Prevention, detection, collaboration, and enforcement
-System of policies, procedures and processes
-Should never be just a piece of paper
-Must be an ongoing process

Question 5

Who needs a Compliance Program?

Answer 5

-Physician Organizations
-Managed Care Organizations
-Ambulance or Transportation Suppliers
-Third Party Billing Companies
-Pharmaceutical Manufacturers
-Hospitals/Academic Medical Centers
-Laboratories
-Research Organizations
-DME Distibutors
-Home Health Agencies/Hospices/Skilled Nursing Facilities
-Behavioral Health Organizations
-Accountable Care Organizations
-Ambulance Providers
-Others

Question 6

Defense Industry Initiative

Answer 6

-Designed to help eliminate waste and bring prices in line
-voluntary self-regulatory guidelines
-Under June Gibbs Brown (IG) at the time
-1990s Health and Human Services (HHS) IG stated a similar process for healthcare

Question 7

Who is responsible for enforcing the rules and regulations under the Medicare and Medicaid Laws outlined as part of the Social Security Act and administered by CMS?

Answer 7

HHS Office of the Inspector General (OIG) with Justice Department

Question 8

What is the annual estimation of healthcare fraud?

Answer 8

tens of billions of dollars

Question 9

What are the benefits of a Compliance Program?

Answer 9

• Safeguard organizations legal responsibility
  -Demonstrates the organizations commitment to good corporate conduct
  -Identify and prevent criminal/unethical conduct
  -Improve quality of care
  -Create a centralized source of information on health care regulations
  -Develop a mechanism for reporting
  -Develop procedures have prompt, thorough investigations of alleged misconduct
  -Initiate immediate and appropriate corrective action
  -Reduce the organization’s exposure to civil damages and penalties, criminal sanctions, and administrative remedies

Question 10

What are Compliance Programs essential?

Answer 10

-Paybacks to fiscal intermediaries or carries may result in audited services
-Probation and court-imposed programs
-Government-designed programs
-Exclusion from governmental programs
-Reduced threat if qui tam (whistleblower) lawsuits

Question 11

Top 10 reasons to implement a Compliance Program

Answer 11

-Demonstrates a provider has commitment to honesty and responsible corporate citizenship
-Reinforce employees’ sense of right and wrong
-Fulfill its legal duty to government and private payors
-Cost effective
-Provides accurate view of employee and contractor behavior relating to fraud and abuse
-Enhances quality of care to patients
-Provides procedures to promptly correct misconduct
-May mitigate and sanction imposed by the government
-Voluntarily implementing a compliance program is preferable to waiting for an agency to impose a mandated compliance program
-May protect corporate directors from personal liability

Question 12

What does a code of conduct do?

Answer 12

Sets forth the company’s vision of itself as a health care provider

Question 13

Corporate Integrity Agreement (CIA)

Answer 13

-to avoid lengthy and expensive litigation, organizations admit no fault or liability but submits itself to a government plan for corrective action
-if no compliance program in place, OIG will develop one
-can be set for a period of time, such as 3-5 years, if not 8
-involve substantial oversight by the OIG
-follow up for CIAs are becoming more severe and involve more unannounced audits

Question 14

The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Answer 14

makes it a criminal offense to submit claims based on incorrect codes or medically unnecessary services

Question 15

The Balanced Budget Act of 1997

Answer 15

has a three strikes and you’re out clause, requiring permanent expulsion for any health care organization found guilty of fraud for a third time

Question 16

Without a Compliance Program what is an increased threat?

Answer 16

Qui tam (whistleblower) lawsuits

Question 17

The False Claims Act (FCA)

Answer 17

-Implemented during the Civil War to control war-time price gouging
-Allows private citizens to bring civil actions against an organization in the name of the United States
-Provides significant financial incentives for private citizens to come forward

Question 18

Qui Tam meaning and benefits

Answer 18

-Whistleblower - “he who brings the action for the king as well as for himself”
-DOJ assumes case - 15-25% of the governments award
-DOJ denies the case - 25-30% of total award
-Are rewarded whether they have tried to solve the problem internally or not

Question 19

Open letters to all providers

Answer 19

-February 27, 1997 the OIG encouraged health care organizations to implement compliance programs to protect themselves from fraud and abuse

Question 20

Federal Sentencing Guidelines (FSG)

Answer 20

-Part of the 1984 Congress enacted Sentencing Reform Act
-Include guidance for assessing fines and detailed methods for calculation of “Culpability Score”
-In 2004 Federal Sentencing Commission released “Chapter 8 Part B” to calculate the Culpability Score
-Possible sanctions include fines, restitution, forfeiture, and probation

Question 21

4 Aggravating Factors for Culpability Score

Answer 21

-An upper level employee has “participated in, condoned, or was willfully ignorant of the offense
-Violation is a repeat offense
-If the government was hindered during its investigation
-If awareness of and tolerance of the violation were pervasive

Question 22

4 Mitigating Factors for Culpability Score

Answer 22

-Organization had an effective Compliance Program
-Organization reported the violation promptly
-Organization cooperated with the government investigators
-Organization accepted responsibility for the violation

Question 23

Steps and organization must take to have an effective Compliance program

Answer 23

-If criminal conduct has an identifiable victim or victims, reasonable steps should include providing restitution and otherwise remedy the harm resulting from the criminal conduct
-self-reporting and cooperation with authorities is necessary
-Assessing the organization’s Compliance program and modifying if necessary to ensure effectiveness

Question 24

2 amendments to FSG

Answer 24

-January 21, 2010
-2 sections of Chapter 2 were amended
-Section 82B.1 are required steps for effective compliance program
-The amendments also enhance the importance of board oversight of a program
-Permits the reduction in culpability score despite the involvement of high-level personnel which created an exception to the exception of a 3-point reduction

Question 25

7 Fundamental Elements of an Effective Compliance Program

Answer 25

-Implementing written policies, procedures, and standards of conduct
-Establish oversight
-develop effective lines of communication and screening
-conduct effective training and education
-conduct internal auditing and monitoring
-enforce standards through well-publicized disciplinary guidelines
-respond promptly to detected offenses and undertaking corrective action

Question 26

10 Obstacles to Effective Compliance Implementation

Answer 26

• no commitment and buy-in from Board and Management
  -Lack of resources
  -dual roles for compliance professionals
  -unclear laws and regulations
  -lack of education and training
  -resistance to change
  -communication problems
  -fear of retaliation/retribution
  -culture of no accountability enforcement
  -territorial struggles amongst functions