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What is a Compliance Program?
The Compliance Manual
Personnel Policy Compliance
ERISA Compliance
Billing and Reimbursement
OSHA Compliance
CLIA Compliance
Compliance has been on the top of healthcare-related news stories. The federal government has enacted a series of rules and regulations which affect the way healthcare providers interact with one another, bill for their services, and generally conduct their professional business lives. Physicians often think of compliance in terms of reducing fraudulent billing and reimbursement. The federal and even state governments have been given a series of tools to fight fraud and abuse in healthcare to include The Federal False Claims Act; The False, Fictitious Claims, Mail and Wire Fraud Act; Stark I and II; The Health Insurance Portability and Accountability Act; and The Balanced Budget Act. It is estimated that the enforcement war chest to fight fraudulent billing practices will top $340 million by 2003.
While compliance has its roots in law, it is really about how you conduct your business. Having a written compliance is still voluntary for medical practices. Yet given the severity of penalties involved (to include time in jail for violations), you are advised to develop a written compliance program which deals with all the various areas of your practice. These areas include, personnel policy, ERISA, Billing and Reimbursement, OSHA and CLIA. Each of these areas requires compliance with certain laws and regulations. As the owner of your practice, you are ultimately responsible for compliance.
You will need to develop a written compliance manual for your practice. Some, or all of the areas mentioned above, will need to be included. Ready-made manuals can also be purchased which can be modified for your individual practice. Your written Compliance Manual should deal with seven major issues:
- Expected Standards of Conduct which include the objective of your practice and how you plan to meet compliance standards
- Appointment of a Compliance Officer, who is an individual or committee which is empowered to develop, implement and enforce the Compliance Program
- Training and Education of all your staff on your Compliance Program to include reporting potential infractions
- Open Communications to the Compliance Officer to report potential violations. This is a written statement and a set of policies to ensure open communication takes place within your office to include confidentiality and keeping good records.
- Disciplinary Procedures which specify how violators will be handled within the practice
- On-going auditing and monitoring of the practice and updating the Program
- Investigations and corrective action which specifies that violations will be examined and states that the Compliance Officer will develop a corrective action plan to remedy the violations
Your practice should have a written personnel policy manual which is designed to inform employees of:
- Approved personnel policies (i.e., time off, overtime pay, fair employment, sexual harassment, etc.)
- Benefit plans the practice offers (to include attainment of eligibility as well as benefits and employer contributions )
Remember that all personnel policies should be in line with federal and applicable state laws.
The Federal government passed far-reaching legislation in 1974 dealing with the administration of pension and welfare benefit plans. Pension plans include a number of retirement-oriented plans such as profit sharing plans, money purchase pension plans, defined benefit plans, 401(k), and IRA. Welfare plans include a wide range of fringe benefit plans such as health insurance, vacation, severance, life insurance and disability plans (just to name a few). While ERISA applies to large employers, it would be wise for you to check your specific obligations for compliance with your attorney or pension administrator. Many physician retirement plans fall into trouble because the benefits are "top heavy" and may be interpreted to discriminate against rank and file employees.
This is often pointed to as the most important area within compliance for the medical practice because unintentional violations can often occur. Having written billing and coding policies and procedures in place is critical to ensure uniform compliance by all office staff. As in the case of all compliance areas, the section of billing and reimbursement should be distributed and your staff trained on your compliance policies and procedures.
The Federal Occupational Safety and Health Act is designed to develop a safe workplace. States have similar laws in place and it is important that your Compliance Manual reflect all relevant regulations and laws in this area. The requirements for OSHA compliance are extensive and involve many areas of workplace safety to include hazardous materials, exposure to pathogens, as well as many general office safety guidelines.
In 1988 Congress passed the Clinical Laboratory Improvement Act (CLIA) to ensure that there were standards in place regarding laboratory testing. With final regulations published in 1992, the elements of the Act are designed to ensure accuracy, reliability and timeliness of patient results whether the tests were performed in a hospital, an off-site lab, or your office. The regulations are based on the complexity of the tests performed which include waived complexity, moderate complexity, and high complexity. If your office lab "performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health", you must register with the CLIA program. Physician offices which are performing waived tests only must apply and obtain a Certificate of Waiver. Waived tests include (but are not limited to) Dipstick or Tablet Reagent Urinalysis for certain specified elements, fecal occult blood, and hemoglobin and erythrocyte sedimentation rate. If your office lab also performs microscopy procedures, you must obtain a Certificate for Provider Performed Microscopy. Oversight for CLIA is performed by the Health Care Financing Administration (HFCA).