SEVEN ELEMENTS OF COMPLIANCE POLICIES

I. Standards of Conduct / Policies and Procedures

Code of Conduct:

The Code of Conduct, first and foremost, demonstrates the practice's ethical attitude and its "system-wide" emphasis on compliance with all applicable laws and regulations. The code is meant for all employees and all representatives of the practice, not just those most actively involved in compliance issues such as coding and billing. This includes vendors, suppliers, and independent contractors, frequently overlooked groups. From the board to volunteers, everyone will receive, read, understand, and agree to abide by the standards of the code of conduct. For this reason the code is written plainly and concisely in an accessible style. Plain and concise does not mean generic, however. The contents of the code of conduct will be tailored to the practice's culture, business, and corporate identity.

Whereas a code of conduct provides guidelines for business decision-making and behavior, the compliance policies and procedures are specific and address identified areas of risk. The practice’s policies and procedures will be developed in such a way that they are integrated into existing organizational standards, taking care that they are realistic and measurable.

Policies and Procedures:

The practice’s policies and procedures will begin with areas of risk. Your Practice should target those areas that apply to the practice specifically and addressed them in the policies and procedures (and educational plan).  The OIG identified Policies and Procedures that your practice should include in its Compliance Plans:

• Record retention (where as well as how long);
• Self-disclosure
• Regular Medicare sanction checks (GSA and OIG (Office of Inspector General)
• Billing policies
• Credit balance
• No charge visits
• Incomplete/unsuccessful procedures
• Documentation requirements

Policies and procedures, like the code of conduct, must be living documents, not

just a binder on a shelf. This is assured through being actively involved in the

Compliance Program.

II. The Compliance Officer

The OIG calls for the designation of a compliance officer "to serve as the focal point for compliance activities.

The main focus of the Compliance Officer/Contact is in the implementation, administration, and oversight of the Compliance Program. Our primary responsibilities, will include:

• Overseeing and monitoring the implementation of the compliance program;
• Reporting on a regular basis to the practice’s governing body
• Revising the compliance program periodically as appropriate
• Developing, coordinating, and participating in a multifaceted educational and training program
• Ensuring that independent contractors and agents are aware of the organization's compliance program requirements
• Ensuring that appropriate background checks are done to eliminate sanctioned individuals and contractors
• Assisting with internal compliance review and monitoring activities; and Independently investigating and acting on matters related to compliance.

III. Education

Education and training are the first and possibly the most important lines of defense for a compliance program. In a field where the pages of regulations number in the thousands, education is the best strategy for prevention. All OIG model guidance identifies the need for education and training. We suggest training be separated into two session types, the first a general session on compliance for all employees.  The second type of session will cover more specific information and be provided to the appropriate level of personnel.

• The body of legal and regulatory knowledge guiding all compliance activity
• Your organization's specific compliance philosophy
• How to handle compliance communication within and outside of your organization
• How compliance violations are defined and how they should be reported
• Policies regarding patient confidentiality handling of patient-specific information
• Claims submission -the activity most at risk for compliance exposure
• Only qualified individuals will be permitted to perform diagnosis and procedure coding
• Physician documentation is the primary determinant of claim submission
• Vendors will be held to the same compliance standards as staff
• Employees involved in compliance violations will be disciplined

IV. Monitoring and Auditing

An effective compliance program is a process of constant evaluation. No one can expect 100% compliance from the first day. The key is to strive for and demonstrate a process for continually improving on compliance activities. The OIG's emphasis on the importance of evaluation is evident in that all corporate integrity agreements call for regular monitoring at least annually. Moreover, all OIG compliance program guidance state that ongoing evaluation is critical to a successful compliance program

Audits should focus on programs or divisions, including external relations with third party contractors, especially those with substantive exposure to government enforcement actions.

• Anti-kickback and self-referral issues
• Credit balances
• Bad debts
• Claim development and submission 
• Record retention
• Cost Reporting
• Marketing
• Compliance Program Processes

Other functions to be reviewed will depend on the risk identified in the Risk Assessment.  Audits will also take into account the practice’s compliance in relation to the OIG Work Plan and any relevant OIG Fraud Alerts. 

Data collection and tracking are the heart and soul of review because they provide trend analysis and a measure of progress. Compliance Officers or reviewers must consider the following techniques when providing monitoring services:

• On site reviews
• Interviews with personnel involved in management, operations, coding, claims development and submission, patient care, and other related activities
• Questionnaires developed to solicit impressions of broad cross-section of the employees and staff
• Reviews of written medical and financial records and other source documents that support claims for reimbursement and Medicare Cost reports
• Review of written material and documentation prepared by the different specialties
• Trend analyses, or longitudinal studies, that seek deviations, positive or negative, in specific areas over a given period
• Job descriptions and job evaluations
• Posing compliance related questions in exit interviews

V. Reporting and Investigation

There are a variety of methods for employees to report potential problems or to raise concerns. The OIG stresses the importance of communication in the compliance process: "An open line of communication between the compliance officer and personnel is equally important to the successful implementation of a compliance program and the reduction of any potential fraud, abuse and waste.”  The most important reporting system is and open door, and best reporting system is on where the employee feels comfortable approaching his or her supervisor and openly discussing any potential problem. As suggested by the OIG, a hotline or help line may be utilized as one of its reporting methods. Other possible options include: e-mail, a drop box and a monthly newsletter.  These systems ensure that 1-800-HHS-TIPS is not the employees’ only option available.

Once a complaint is received or a question rose, it is investigated. Remembering, to the OIG, documentation is everything. All complaints must be logged in and tracked.  The log sheet is  supplemented with a complaint specific issue form which is a nice way to meet the OIG requirements. Noting that a complaint was received is not enough. A clearly stated procedure must be developed and implemented.

VI. Enforcement and Discipline

Fair, equitable, and consistent are the watchwords for enforcing the standards of conduct and the policies and procedures. The place to start with enforcement is back at the beginning with the standards of conduct and the policies and procedures. As suggested by the OIG, compliance program should include a written policy statement setting forth the degrees of disciplinary actions that may be imposed upon corporate officers, managers, employees, physicians and other health care professionals for failing to comply with the standards and policies and applicable statues and regulations.

5 Basic Points to consider:

• Noncompliance will be punished
• Failure to report noncompliance will be punished
• An outline of disciplinary procedures
• The parties responsible for appropriate action
• A promise that discipline will be fair and consistent 

Enforcement is not just about discipline, of course. Goals and objectives for individuals and departments can include specific references to compliance. Achievement of those goals, especially when celebrated, is a positive reinforcement that encourages support for and enforcement of the compliance program. Performance appraisals need not focus solely on issues of noncompliance. They can, for example, make note of favorable or improved audit or review outcomes.

VII. Response and Prevention

If there should ever be reason to believe that misconduct or wrongdoing has actually occurred, the ability to respond appropriately is vital. Failure to respond or to engage in lengthy delay can have serious consequences. Since the OIG notes that violations of the compliance program and other types of misconduct threaten an organization's status as a reliable, honest, and trustworthy provider capable of participating in federal health care programs. Detected but uncorrected misconduct can seriously endanger the mission, reputation, and legal status of the provider.  However daunting it may feel to be faced with the possibility of misconduct, remember that one of the goals of a compliance program is detection. Having found a problem is an indication the program is working.

Detailed documentation is critical. If it should be necessary to defend in a criminal or civil trial, a clear paper trail will make the process much easier. Our process of documentation will include:

• A description of the potential misconduct and how it was reported
• A description of the investigative process
• List of relevant documents reviewed
• List of employees interviewed
• Employee interview questions and notes
• Changes to policies and procedures, if appropriate
• Documentation of any disciplinary actions
• Investigation final report with recommended remedial actions

FRAUD & ABUSE EXCERPTS

DOLLARS LOST TO FRAUD 

People often ask how much fraud, waste and abuse there is in health care, and how much it impacts them personally. The General Accounting Office estimates 10 percent of Medicare dollars are lost to fraud. The latest Office of Inspector General (OIG) study indicates about 7 percent of Medicare's payments or nearly $13 billion per year are inappropriate. This can be due to innocent but wasteful errors, systematic abuse, or outright fraud. These numbers have dropped since 1996, but still represent a serious concern. The sheer magnitude of the numbers means that the problem negatively impacts on each and every one of us, not just Medicare beneficiaries. This loss to the Medicare Trust Fund is not acceptable and all of us need to continue our joint activities to reduce it and help assure that our beneficiaries continue to receive needed care in the future. 

OPERATION RESTORE TRUST 

The OIG has been partnering with the Administration on Aging, the Health Care Financing Administration (HCFA), and others for several years in an initiative called Operation Restore Trust. ORT is a Secretarial long-term initiative to reduce the incidence of fraud and abuse in Medicare and Medicaid. It has two distinct phases: 1) the 2-year demonstration limited to five States and specific program areas which ended in March 1997; and 2) a multi-year continuation which institutionalized the "best practices" refined during the demonstration project and includes all program areas with a few initially selected for special attention. ORT was and continues to be an effective tool in fighting fraud and abuse, but there are many other areas where the OIG, in conjunction with other agencies inside and outside HHS, is attacking fraud. Some of these areas will be discussed in subsequent articles. 

June Gibbs Brown, Inspector General – October 1, 1998 - March 31, 1999 Inspector General’s Semi-Annual Report on Fraud & Abuse.

"As most of you are aware, the Congress greatly increased the resources and authorities of my office to combat health care fraud, and an intensified crackdown is being pursued with the full support of the Administration. We are bolstering our investigative and audit staffs, formulating new anti-fraud strategies, and strengthening our collaboration with the Health Care Financing Administration, the Department of Justice, and other Federal, state, and local law enforcement offices. As Inspector General, I am committed to vigorously pursue civil and criminal action against those who defraud this nation's health care programs."