Healthcare Compliance 101

Archive for the month “October, 2011”

Evaluating and Improving a Compliance Program

Evaluating and Improving a Compliance Program

Health care is one of the most highly regulated industries in the United States.  Thousands of health care entities have been excluded from participating in federal programs, such as Medicare and Medicaid, for violating laws.  Government agencies, such as the Federal Bureau of Investigation (FBI), Office of Inspector General (OIG), Department of Justice (DOJ) and Centers for Medicare and Medicaid Services (CMS) target health care fraud and abuse as high priority areas to conduct inquiries and investigations.  In light of the proliferation of fraud and abuse legislation and enforcement activities directed at the health care industry, it is becoming imperative for health care organizations to implement compliance programs not only to prevent violations but also to reduce the potential for liability should violations occur.

What is the Purpose of a Compliance Program?

The purpose of a compliance program is aimed at ensuring that the organization, its employees, and associates comply with applicable laws, regulations, and standards.  Health care compliance programs should outline a comprehensive strategy to ensure the submission of accurate claims to federal, state, and commercial payers.  The compliance program should include policies and procedures to comply with other applicable laws and regulations relating to the delivery of health care products and services. 

What Makes a Compliance Program Work?

Programs that work are about two things: a management commitment to do the right thing, and effective management steps to make that happen.  It is about making sure that all those who work for the organization know what to do, and believe that the organization is serious about acting legally and ethically.  

Compliance Program Foundation

The Office of the Inspector General, “OIG,” has spoken authoritatively on the basic elements of an effective compliance program.  The Federal Sentencing Guidelines have defined an effective compliance program as “a program that has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal conduct.”(1)  The Sentencing Guidelines outlines seven key elements of a compliance program.

 1.  Compliance Standards  “The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations.” Comment 3.(k)(1).

2.  High Level Responsibility “Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with the standards and procedures and have sufficient resources and authority to assure compliance.” Comment 3.(k)(2).

3.  Trustworthy Individuals  “The organization must have used due care not to delegate substantial dicretionary authority to individuals whom the organization knew, or should have know through the exercise of due diligence, had a propensity to engage in illegal activities.” Comment3.(k)(3).

4.  Education  “The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.” Comment3.(k)(4).

5.  Monitoring and Auditing  “The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations by its employees and other agents.” Comment3.(k)(5).

6.  Enforcement and Discipline  “The standards must be consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.” Comment 3.(k)(6).

7.  Response and Prevention  “After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses. including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations.” Comment3.(k)(7).

Health care organizations have recognized that compliance programs are important because the regulatory environment in which they operate is exceedingly complex, and they have a fundamental obligation to their patients and the public to ensure that participation in government and private reimbursement systems and the operation of health care organizations are consistent with applicable laws and regulations.

Healthcare Compliance Consulting, Inc. (HCC) has been providing consulting services and compliance programs to health care providers for almost a decade.  Our clients include medical doctors, cardiologists, allergy physicians, dermatologists, chiropractors, home health agencies and dentists. 


(1) Federal Sentencing Guidelines, §8A.2. Comment 3.

Healthcare Compliance Consulting, Inc.
Developers of Healthcare Compliance for Less Than $2.00 Per Day.
5755 Heather Ridge Drive
St. Paul, Minnesota 55126          
Phone: (651) 484-4303
Fax: (651) 484-6213
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