II. Elements of a Compliance Program for Ambulance Suppliers

A. Basic Elements of a Compliance Program

The following basic components have become accepted as the building blocks of an effective compliance program:

1. Development of Compliance Policies and Procedures

The ambulance supplier should develop and distribute written standards of conduct, as well as written policies and procedures, that reflect the ambulance supplier’s commitment to compliance and address specific areas of potential fraud or abuse. These written policies and procedures should be reviewed periodically (e.g., annually) and revised as appropriate to ensure they are current and relevant.

2. Designation of a Compliance Officer

The ambulance supplier should designate a compliance officer and other appropriate bodies (e.g., a compliance committee) charged with the responsibility for operating and monitoring the organization’s compliance program. The compliance officer should be a high-level individual in the organization who reports directly to the organization’s upper management, such as the chief executive officer or board of directors. The OIG recognizes that an ambulance supplier may tailor the job functions of the compliance officer position by taking into account the size and structure of the organization, existing reporting lines, and other appropriate factors.

3. Education and Training Programs

A key element of a compliance program should be regular training and education of employees and other appropriate individuals. Training content should be tailored appropriately and should be delivered in a way that will maximize the chances that the information will be understood by the target audience.

4. Internal Monitoring and Reviews

Appropriate monitoring methods are essential to detect and identify problems and to help reduce the future likelihood of problems.

5. Responding Appropriately to Detected Misconduct

Ambulance suppliers should develop policies and procedures directed at ensuring that the organization responds appropriately to detected offenses, including the initiation of appropriate corrective action. An organization’s response to detected misconduct will vary based on the facts and circumstances of the offense. However, the response should always be appropriate to resolve and correct the situation in a timely manner. The organization’s compliance officer, and legal counsel in some circumstances, should be involved in situations when serious misconduct is identified.

6. Developing Open Lines of Communication

Ambulance suppliers should create and maintain a process, such as a hotline or other reporting system, to receive and process complaints and to ensure effective lines of communication between the compliance officer and all employees. Further, procedures should be adopted to protect the anonymity of complainants, where the complainants desire to remain anonymous, and to protect whistleblowers from retaliation.

7. Enforcing Disciplinary Standards Through Well-Publicized Guidelines

Ambulance suppliers should develop policies and procedures to ensure that there are appropriate disciplinary mechanisms and standards that are applied in an appropriate and consistent manner. These policies and standards should address situations in which employees or contractors violate, whether intentionally or negligently, internal compliance policies, applicable statutes, regulations, or other federal health care program requirements.

Developing and implementing a compliance program may require significant resources and time. An individual ambulance supplier is best situated to tailor compliance measures to its own organizational structure and financial capabilities. In addition, compliance programs should be reviewed periodically to account for changes in the health care industry, federal health care statutes and regulations, relevant payment policies and procedures, and identified risks.

B. Evaluation and Risk Analysis

It is prudent for ambulance suppliers conducting a risk analysis to begin by performing an evaluation of internal and external factors that affect their operations. These may include internal systems and management issues, as well as the federal health care program requirements that govern their business operations. In many cases, such evaluation will result in the creation and adoption or revision of written policies and procedures. The evaluation process may be simple and straightforward or it may be fairly complex and involved. For example, an evaluation of whether an ambulance supplier’s existing written policies and procedures accurately reflect current federal health care program requirements is straightforward. However, an evaluation of whether an ambulance supplier’s actual practices conform to its policies and procedures may be more complex and require several analytical evaluations to determine whether system weaknesses are present. Even more complex is an evaluation of an ambulance supplier’s practices in light of applicable statutes, regulations, and other program requirements, when there are no pre-existing written policies and procedures.

The evaluation process should furnish ambulance suppliers with a snapshot of their strengths and weaknesses and assist providers in recognizing areas of potential risk. We suggest that ambulance suppliers evaluate a variety of practices and factors, including their policies and procedures, employee training and education, employee knowledge and understanding, claims submission process, coding and billing, accounts receivable management, documentation practices, management structure, employee turnover, contractual arrangements, changes in reimbursement policies, and payor expectations.

1. Policies and Procedures

Because policies and procedures represent the written standard for daily operations, an ambulance supplier’s policies and procedures should describe the normal operations of the ambulance supplier and the applicable rules and regulations. Further, written policies and procedures should go through a formal approval process within the organization and should be evaluated on a routine basis, and updated as needed, to reflect current ambulance practices (assuming these practices are appropriate and comport with the relevant statutes, regulations, and program requirements). In addition, ambulance suppliers should review policies and procedures to ensure that they are representative of actual practices. For example, an ambulance supplier’s policy for reviewing ambulance call reports (ACRs) should not state that it will review 100 percent of its ACRs, unless the ambulance supplier is capable of performing and enforcing such comprehensive reviews.

2. Training and Education

Ensuring that a supplier’s employees and agents receive adequate education and training is essential to minimizing risk. Employees should clearly understand what is expected of them and for what they will be held accountable. Suppliers should also document and track the training they provide to employees and others.

An ambulance supplier should consider offering two types of compliance training: compliance program training and job-specific training. If an ambulance supplier is implementing a formal compliance program, employees should be trained on the elements of the program, the importance of the program to the organization, the purpose and goals of the program, what the program means for each individual, and the key individuals responsible for ensuring that the program is operating successfully. Compliance program education should be available to all employees, even those whose job functions are not directly related to billing or patient care.

Ambulance suppliers should also train employees on specific areas with regard to their particular job positions and responsibilities, whether or not as part of a formal compliance plan. The intensity and the nature of the specific training will vary by employee type. Training employees on the job functions of other people in the organization may also be an effective training tool. Appropriate cross-training can improve employees’ overall awareness of compliance and job functions, thereby increasing the likelihood that an individual employee will recognize non-compliance. Training should be provided on a periodic basis to keep employees current on ambulance supplier requirements, including, for example, the latest payor requirements. Ambulance suppliers should conduct or make available training for employees at least yearly, and more often if needed.

Generally, employees who attend interactive training better comprehend the material presented. Interactive training offers employees the chance to ask questions and receive feedback. When possible, ambulance suppliers should use ‘‘real’’ examples of compliance pitfalls provided by personnel with ‘‘real life’’ experience, such as emergency medical technicians and paramedics.

The OIG is cognizant that offering interactive, live training often requires significant personnel and time commitments. As appropriate, ambulance suppliers may wish to consider seeking, developing, or using other innovative training methods. Computer or internet modules may be an effective means of training if employees have access to such technology and if a system is developed to allow employees to ask questions. The OIG cannot endorse any commercial training product; it is up to each ambulance supplier to determine if the training methods and products are effective and appropriate.

Whatever form of training ambulance suppliers provide, the OIG also recommends that employees complete a post-compliance training test or questionnaire to verify comprehension of the material presented. This will allow a supplier to assess the effectiveness and quality of its training materials and techniques. Additionally, training materials should be updated as appropriate and presented in a manner that is understandable by the average trainee. Finally, the OIG suggests that the employees’ attendance at, and completion of, training be tracked and appropriate documentation maintained.

3. Assessment of Claims Submission Process

Ambulance suppliers should conduct periodic claims reviews to verify that a claim ready for submission, or one that has been submitted and paid, contains the required, accurate, and truthful information required by the payor. An ambulance claims review should focus, at a minimum, on the information and documentation present in the ACR, the medical necessity of the transport as determined by payor requirements, the coding of the claim, the co-payment collection process, and the subsequent payor reimbursement. The claims reviews should be conducted by individuals with experience in coding and billing and familiar with the different payors’ coverage and reimbursement requirements for ambulance services. The reviewers should be independent and objective in their approach. Claims reviewers who analyze claims that they themselves prepared or supervised often lack sufficient independence to accurately evaluate the claims submissions process and the accuracy of individual claims. The appearance of a lack of independence may hinder the effectiveness of a claims review.

Depending on the purpose and scope of a claims review, there are a variety of ways to conduct the review. The claims review may focus on particular areas of interest (e.g., coding accuracy), or it may include all aspects of the claims submission and payment process. The universe from which the claims are selected will comprise the area of focus for the review. Once the universe of claims has been identified, an acceptable number of claims should be randomly selected. Because the universe of claims and the variability of items in the universe will vary, the OIG cannot specify a generally acceptable number of claims for purposes of a claims review. However, the number of claims sampled and reviewed should be sufficient to ensure that the results are representative of the universe of claims from which the sample was pulled.

Ambulance suppliers should not only monitor identified errors, but also evaluate the source or cause of the errors. For example, an ambulance supplier may identify through a review a certain claims error rate. Upon further evaluation, the ambulance supplier may determine that the errors were a result of inadequate documentation. Further evaluation may reveal that the documentation deficiencies involve a limited number of individuals who work on a specific shift. It is the ambulance supplier’s responsibility to identify such weaknesses and to correct them promptly. In this example, at a minimum, additional employee training should be required and any identified overpayment repaid. A detailed and logical analysis will make claims reviews useful tools for identifying risks, correcting weaknesses, and preventing future errors.

Ambulance suppliers should consider using a baseline audit to develop a benchmark against which to measure performance. This audit will establish a consistent methodology for selecting and examining records in future audits. Comparing audit results from different audits will generally yield useful results only when the audits analyze the same or similar information and when matching methodologies are used.

As part of its compliance efforts, an ambulance supplier should document how often audits or reviews are conducted and the information reviewed for each audit. The ambulance supplier should not only use internal benchmarks, but should utilize external information, if available, to establish benchmarks (e.g., data from other ambulance suppliers, associations, or from payors). Additionally, risk areas may be identified from the results of the audits.

If a material deficiency is identified that could be a potential criminal, civil, or administrative violation, the ambulance supplier may disclose the matter to the OIG via the Provider Self-Disclosure Protocol. The Provider Self-Disclosure Protocol was designed to allow providers/suppliers to disclose voluntarily potential violations in their dealings with the federal health care programs. In all cases, identified overpayments should be reported to the appropriate payor.

a. Pre-Billing Review of Claims

As a general matter, ambulance suppliers should review claims on a pre-billing basis to identify errors before claims are submitted. If there is insufficient documentation to support the claim, the claim should not be submitted. Pre-billing reviews also allow suppliers to review the medical necessity of their claims. If, as a result of the pre-billing claims review process, a pattern of claim submission or coding errors is identified, the ambulance supplier should develop a responsive action plan to ensure that overpayments are identified and repaid.

b. Paid Claims

In addition to a pre-billing review, a review of paid claims may be necessary to determine error rates and quantify overpayments and/or underpayments. The post-payment review may help ambulance suppliers in identifying billing or coding software system problems. Any overpayments identified from the review should be promptly returned to the appropriate payor in accordance with payor policies.

c. Claims Denials

Ambulance suppliers should review their claims denials periodically to determine if denial patterns exist. If a pattern of claims denials is detected, the pattern should be evaluated to determine the cause and appropriate course of action. Employee education regarding proper documentation, coding, or medical necessity may be appropriate. If an ambulance supplier believes its payor is not adequately explaining the basis for its denials, the ambulance supplier should seek clarification in writing.

4. System Reviews and Safeguards

Periodic review and testing of a supplier’s coding and billing systems are also essential to detect system weaknesses. One reliable systems review method is to analyze in detail the entire process by which a claim is generated, including how a transport is documented and by whom; how that information is entered into the supplier’s automated system (if any); coding and medical necessity determination protocols; billing system processes and controls, including any edits or data entry limitations; and finally the claims generation, submission, and subsequent payment tracking processes. A weakness or deficiency in any part of the supplier’s system can lead to improper claims, undetected overpayments, or failure to detect system defects.

Each ambulance supplier should have computer or other system edits to ensure that minimum data requirements are met. For example, under CMS’s new fee schedule, each transport claim that does not have an originating zip code listed should be ‘‘flagged’’ by the system. Other edits should be established to detect potentially improper claims submissions. A systems review is especially important when documentation or billing requirements are modified or when an ambulance supplier changes its billing software or claims vendors. As appropriate, ambulance suppliers should communicate with their payor when they are implementing significant changes to their system to alert the payor to any unexpected delays, or increases or decreases in claims submissions.

Ambulance suppliers should ensure that their electronic or computer billing systems do not automatically insert information that is not supported by the documentation of the medical or trip sheets. For example, billing systems targeting optimum efficiency may be set with defaults to indicate that a physician’s signature was obtained following an emergency room transport. If information is automatically inserted onto a claim submitted for reimbursement, and that information is false, the ambulance supplier’s claims will be false. If a required field on a claim form is missing information, the system should flag the claim prior to its submission.

5. Sanctioned Suppliers

Federal law prohibits Medicare payment for services furnished by an excluded individual, such as an excluded ambulance crew member. Accordingly, ambulance suppliers should query the OIG and General Services Administration (GSA) exclusion and debarments lists before they employ or contract with new employees or new contractors. Additionally, ambulance suppliers should periodically (at least yearly) check the OIG and GSA web sites to ensure that they are not employing or contracting with individuals or entities that have been recently convicted of a criminal offense related to health care or who are listed as debarred, suspended, excluded, or otherwise ineligible for participation in federal health care programs. The OIG and GSA Web sites are listed at

http://oig.hhs.gov and http://www.gsa.gov/Portal/gsa/ep/contentView.do?P=VXX&contentId=19944&contentType=GSA_BASIC respectively, and contain specific instructions for searching the exclusion and debarment databases.

C. Identification of Risks

This ambulance CPG discusses many of the areas that the ambulance industry, the OIG, or CMS have identified as common risks for many ambulance suppliers. However, this CPG does not identify or discuss all risks that an ambulance supplier may itself identify. Moreover, the CPG may ascribe more or less risk to a particular practice area than an ambulance supplier would encounter based on its own internal findings and circumstances. Because there are many different types of risk areas, ambulance suppliers should prioritize their identified risks to ensure that the various areas are addressed appropriately. Apart from the risks identified in this CPG, ambulance suppliers of all types (e.g., small, large, rural, emergency, non-emergency) should evaluate whether they have any unique risks attendant to their business relationships or processes. For example, a small, rural not-for-profit ambulance supplier may identify risk areas different from those of a large, for-profit ambulance chain that serves a primarily urban area. To stay abreast of risks affecting the ambulance and other health care industries, the OIG recommends that ambulance suppliers review OIG publications regarding ambulance services, including OIG advisory opinions, OIG fraud alerts and bulletins, Office of Evaluation and Inspections (OEI) reports, and Office of Audit Services reports, all located on the OIG’s Web site at http://oig.hhs.govA review of industry-specific trade publications will also help ambulance suppliers remain current on industry changes.

D. Response to Identified Risks

An ambulance supplier should develop a reasonable response to address identified risk areas, including written protocols and reasonable time frames for specific situations. Developing timely and appropriate responsive actions demonstrates the supplier’s commitment to address problems and concerns. Determining whether identified problems respond to corrective actions may require continual oversight.

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