Ambulance suppliers have felt an escalating need for industry guidance from the OIG, considering the new Medicare fee schedule for ambulance services, the varying ways in which ambulance services are furnished in the United States, and the multiple scenarios under which ambulance claims are billed. Moreover, arrangements with ambulance suppliers have been the focus of a number of OIG advisory opinions interpreting the applicability of the antikickback statute and related fraud and abuse laws to such arrangements. The OIG attempted to answer the industry's need with its compliance program guidance for ambulance suppliers. 68 Fed. Reg. 14,245 (Mar. 24, 2003). The OIG offers a useful discussion of arrangements and relationships that are particular to the ambulance supplier community, with specific references to the new, revised Medicare fee schedule. Ambulance services may be furnished either by proprietary, for-profit ambulance companies or by governmental ambulance suppliers. Among governmental ambulance suppliers, some function as Medicare suppliers billing that program and other payers, while others offer services as an arm of firefighting companies — both employed and voluntary. In addition, hospitals continue to play a major role in making ambulance services available, particularly air ambulance services and critical care ground/specialty-care transport services.

The Ambulance Guidance also provides direction with respect to the billing complexities of ambulance services. Some ambulance claims are billable to Medicare and Medicaid, while others are billed to other providers that are responsible for transport services as part of their own payment rate. Ambulance services that are not covered under Medicare and Medicaid either are billed to individuals or are provided through a governmental program to the public. Moreover, the fact that many, but not all, ambulance transports are provided through emergency medical services (EMS) protocols affects issues of choice and incentive.

It bears special observation that, notwithstanding the intensive focus on national security and the manner in which public safety agencies responded to the September 11th attacks, there is no national, uniform EMS system or template. The Ambulance Guidance is interesting because it cites and addresses a variety of relationships in which ambulance suppliers engage, irrespective of their particular services or geographic location.

The Ambulance Guidance follows the pattern of other, comparable guidance the OIG has furnished to other types of providers. It is comprised of five sections: an introduction, an outline of basic elements for a compliance program, a discussion of compliance and fraud and abuse risks for ambulance suppliers, special issues involving Medicaid transportation issues, and risks to ambulance suppliers under the antikickback statute.

Ambulance suppliers are advised to follow what has become the OIG's standard compliance program template: establishing compliance program policies and procedures; designation of a compliance officer or contact person; training and education; internal monitoring and reviews; responding to and correcting detected infractions; keeping open lines of communication; and enforcing discipline through well-publicized standards. The manner in which these elements are met will be dictated by the size and nature of the ambulance supplier. If the ambulance supplier functions as part of a larger organization, such as a hospital-based or affiliated entity, that already has a compliance program in place, that program should be reviewed to ensure it encompasses ambulance services - including training, education, and monitoring activities.

The Ambulance Guidance highlights examples of fraudulent practices the OIG has targeted in the past, including:

Situations in which individuals have other appropriate means of transportation;
Medically unnecessary trips;
Excessive claims;
Trips billed but not furnished;
Misrepresentation of the transport destination to secure coverage;
False documentation;
Individual billing of group transport claims, as if there were no group; and
Upcoding basic life support to advanced life support without proper supporting documentation.

Evaluation and Risk Analysis
Policy and Procedure Review
As the OIG has typically recommended in its other compliance program guidance, the ambulance supplier should review existing policies and procedures, contracts, and other relationships, as well as ongoing practices for which no policy or procedure exists. The OIG notes that policies and procedures should be practical. For example, a compliance program should not call for a review of all ambulance call reports if such a comprehensive review is not realistic for the supplier.

Compliance Training
The OIG also recommends that compliance training include training on both the compliance program itself and the performance of duties in accordance with policies and requirements, and encourages the use of live training — particularly by paramedics. Cross-training is encouraged as a way to ensure internal familiarity and scrutiny. Staff attendance at and completion of training should be documented.

Claims Review
The OIG recommends that ambulance suppliers review a representative random sample of ambulance claims, either generally or targeted to an area of interest. As part of that review, the OIG suggests that ambulance suppliers review documentation on ambulance call reports, compliance with medical necessity requirements, coding, copayment collection, and the results of payer review and reimbursement. Such reviews can be conducted prior to the submission of claims, although the OIG notes that a review of paid claims can identify coding software and billing errors or can quantify problems otherwise discovered. The OIG urges ambulance suppliers to use independent claims reviewers to promote accuracy, effectiveness, and objectivity. The OIG also recommends using a baseline audit as a useful tool for ensuring that audit results are compared using comparable information and methodologies. The OIG notes that tracking of claims denials can also be an effective tool in assessing the ambulance supplier's claims process.

System Reviews
The Ambulance Guidance recommends that each ambulance service implement computer or system edits to ensure that minimum data requirements are met. For example, a system that does not capture point of pick-up by zip code, a key data element under the new Medicare fee schedule, would be problematic. Likewise, a system that does not flag claims that code an emergency pick-up where the point of delivery is not a hospital emergency department could allow improper claims to go undetected. (Ground ambulance suppliers will recognize that there will be scene calls at which the delivery point is a location where an air ambulance supplier picks up the patient, for which both ambulance suppliers will submit claims for their respective transports.) The OIG expresses concern about billing software that, for efficiency, automatically inserts information in a field where there may not be support for that presumption, such as a system that assumes a physician signature, when required in advance of a claim, has always been obtained.

Monitoring and Responding to Possible Risks
The OIG makes points regarding risk monitoring that are common among its compliance program guidances. For instance, an ambulance supplier should ensure it is not employing staff that is prohibited from rendering services by routinely checking the OIG's list of excluded individuals and entities. An ambulance supplier also should monitor relevant risk areas by checking OIG and industry guidance, and demonstrate by proactive response that identified problems are taken seriously.

Targeted Risk Areas
The Ambulance Guidance identifies a number of targeted risk areas for ambulance suppliers, based on past prosecutions and investigations.

Medical Necessity
The OIG has investigated transports billed for trips to noncovered destinations, as well as transports that were not medically necessary. For example, the use of an ambulance to transport a patient who has been sitting unaided in a chair all day or who could be transported by wheelchair would not qualify as medically necessary. Trip sheets that do not document a patient as bed-confined can lead to improper coding. The OIG also has prosecuted ambulance suppliers under allegations of upcoding, including billing at the advanced life support level when not merited, such as where there were no services from appropriately certified staff for the level of care billed. The Ambulance Guidance notes that a non-emergency transport will be reimbursed under the Medicare fee schedule if the patient is bed-confined with a medical condition such that other means of transportation are contraindicated, or if the beneficiary's medical condition, regardless of bed confinement, is such that ambulance transport is medically required. To be considered bed-confined, the patient must be unable to get out of bed without assistance, unable to ambulate, and unable to sit in a chair or wheelchair. Documentation must support these findings. If medical necessity is unclear, the OIG urges, the patient's condition should be documented.

Advanced beneficiary notices (ABNs) often are not required for ambulance transports, since they are not to be given to a patient under duress, such as during an emergency transport. However, the OIG notes that an ambulance supplier's compliance program should include a review of ABN compliance for noncovered non-emergent transports. The Ambulance Guidance warns that pre-signed or mass-produced physician certification statements can create the risk that transports would be mischaracterized as medically necessary. In addition, the OIG emphasizes that physician certification statements must be signed by a physician or other appropriate health care professional. The OIG cites to a past prosecution stemming from billing for routine transports to doctors' or dialysis appointments for the convenience of patients.

Documentation and Billing
In guiding ambulance suppliers on documentation requirements, the OIG identifies key data elements that should be captured:

Any dispatch instructions;
Circumstances contraindicating other modes of transport;
Information to confirm the patient is bed-confined;
The person ordering the transport;
Duration of the transport;
Dispatch, arrival, and destination times;
Mileage, noting that only "loaded miles," i.e., with the patient on board, are reimbursable;
Pick-up and destination codes;
Zip codes, which are used to determine the point of pick-up so as to determine applicable reimbursement, including the address for verification; and
Services provided, including drugs and supplies.

With respect to coding, the OIG cautions that past medical history and conditions are not relevant unless related to the patient's condition at the time of transport. The Ambulance Guidance notes that Medicare only pays for transports to the closest appropriate facility, such that the beneficiary may be responsible for payment for any additional mileage. (This comment is notable in that it confirms that a transport to another facility at the patient's request does not result in the entire transport not being covered.) Verification of the proper point of pickup by zip code must be documented. Ambulance suppliers should have, as part of their compliance programs, a clear understanding of circumstances under which payment for ambulance transports provided "under arrangements" with another provider is included under that provider rate and therefore should not be billed separately.

Medicaid Ambulance Coverage
In discussing compliance standards concerning Medicaid coverage, the OIG cites to specific issues that should be addressed through the compliance process. The Ambulance Guidance confirms that Medicaid programs may cover services that Medicare does not reimburse, depending on the state plan. These include, for example, coverage for wheelchair vans, ambulances and cabs, and transportation to medical appointments.

Antikickback Concerns
The Ambulance Guidance includes a separate discussion of the antikickback statute that cites specific areas of scrutiny applicable to ambulance suppliers, based on past investigations and prosecutions. The OIG highlights referral sources for ambulance services such as 9-1-1 centers and other EMS dispatch arrangements, private dispatch arrangements, first responders, hospitals, nursing facilities, assisted living facilities, home health agencies, physician offices, and patients. The OIG acknowledges that "ambulance suppliers — particularly those furnishing emergency services — have relatively limited abilities to generate business for other providers or to inappropriately steer patients to particular emergency providers." 68 Fed. Reg. at 14,252. Nonetheless, and notwithstanding that ambulances are often called by an EMS dispatcher or may be mandated by a local EMS protocol, a physician order, or the patient's medical condition to transport a patient to a particular facility, the OIG provides examples of when an ambulance supplier may be a source of referrals. The OIG names hospitals and other receiving facilities, as well as "second responders," as examples of entities receiving referrals from ambulance suppliers.

With respect to contracting and other relationships that may implicate the antikickback statute, the OIG offers three rules of thumb. The first is to engage in transactions with referral sources based on fair market value in arm's-length transactions without taking into consideration referrals or other business generated between the parties, disclosing and structuring discounts to comply with the applicable safe harbor. The second is to avoid "swapping," i.e., providing services under a lower-than-cost payment arrangement (such as "under-arrangement contracting" when an ambulance supplier provides services another provider has to cover under its own payment rate) in exchange for an opportunity to provide services for which the ambulance supplier may bill directly. The third is to avoid exchanges of remuneration such as gifts (for more than nominal value) or free items and services in exchange for referrals.

Certain arrangements merit review with "particular care" according to the Ambulance Guidance:

EMS contracts with cities or municipal services: The OIG expresses caution about seeking inflated payments from ambulance suppliers that exceed the city or municipality's costs of providing services to the ambulance supplier, in exchange for access to the EMS system under 9-1-1 or comparable systems. A city or other political subdivision (including fire districts) may not require the waiver of copayments for residents but may pay uncollected out-of-pocket copayments on behalf of residents — through lump-sum or periodic payments that reasonably approximate uncollected copayments in the aggregate.
Restocking arrangements: It is interesting that the Ambulance Guidance commences a discussion of restocking arrangements with a statement that EMS restocking arrangements are "common" with respect to supplies and drugs used in transporting patients to hospitals and emergency facilities. It refers ambulance companies to the restocking safe harbor regulation as a way to eliminate risk, which is consistent with the concept that arrangements that are not fully compliant with a safe harbor may not be illegal. Nonetheless, the OIG cautions that, aside from any antikickback issues, an ambulance supplier can be responsible for the cost of drugs under the applicable rate under the ambulance fee schedule. The Ambulance Guidance refers suppliers to their payors during the ambulance fee schedule transition period. Greater guidance, therefore, may be needed if the implication of this language is that, under the new Medicare fee schedule for ambulance services, ambulances should be responsible for drugs and supplies that are restocked because of the way the new fee schedule rates are set. It should be noted that the ambulance fee schedule rates were established based on a congressionally imposed aggregate base-year ceiling on Medicare reimbursement. That is, the total amount Medicare reimbursed for ambulance services was the starting point for the fee schedule negotiated rulemaking process that resulted in the current methodology. If the OIG appropriately acknowledges that restocking arrangements have been "common" in the past, this would mean that the costs of the drugs and supplies often provided by hospitals and emergency facilities in the past to ambulance suppliers were omitted from the base-year amount on which the new Medicare fee schedule was based. Thus, if CMS takes the position that such items are included in the fee schedule rates in a way that affects restocking, this may present a reimbursement challenge. Greater discussion on this aspect of the Ambulance Guidance may be needed.
Arrangements with other responders: The OIG's guidance in this respect is interesting because it recognizes that fair-market-value payment from an ambulance supplier to a first responder may be appropriate but not in a manner that reimburses for making or influencing the referral to the transporting ambulance service. (Recent CMS Program Memorandum guidance requires such arrangements to be in writing before one ambulance supplier may bill at a higher code based on services rendered by another responder. See Program Memorandum AB-02-131 (Sept. 27, 2002).)
Arrangements with hospitals and nursing facilities: Hospitals and nursing facilities are "key" sources of referrals. They also often require transports for which payment must be made by the facility and not through a Medicare Part B claim.
Arrangements with patients: HIPAA prohibits remuneration to a patient to induce the patient to select a particular provider submitting a claim to Medicare or a state health care benefit program such as Medicaid, including, for example, routine waivers of copayments, "insurance programs" in which coverage is only available for the ambulance services of a particular supplier, and free goods and services. Financial hardship waivers are permitted on a case-by-case basis so long as they are not advertised.
Pronouncements of death: Claims submitted for a patient who has died are subject to three billing rules: (1) if the patient is pronounced dead before the ambulance is called there is no payment; (2) if the patient is pronounced dead before the ambulance that was called arrives, payment is at the basic life support (BLS) rate; and (3) if the patient dies after being transported the payment is as if the patient were alive.
Multiple-patient transports: Payment for multiple-patient transport historically has been based on local carrier policy, but the new Medicare fee schedule has allocation rules under which the ambulance supplier is paid a percentage of the applicable base rate.
Multiple ambulances respond: Only the transporting ambulance may bill when multiple ambulances respond to a call. Fair-market-value payment may be arranged between the responding suppliers for their respective services.
Billing substantially in excess of usual charges: The OIG has the authority to exclude an ambulance supplier for submitting claims that are substantially in excess of the supplier's actual charges. Even under the new Medicare fee schedule, Medicare pays the lower of the fee schedule and the ambulance supplier's actual charges. If the ambulance supplier so routinely discounts its actual charges that its median charge for non-Medicare and non-Medicaid claims is less than the fee schedule, the supplier's actual charge may be less than the amount represented and Medicare may be entitled to the lower actual charge than the fee schedule payment that would otherwise be due. Suppliers should review and update their charges and discounting practices accordingly.

Conclusion
In issuing the Ambulance Guidance, the OIG acknowledges the challenges that ambulance suppliers face with respect to compliance issues. While the guidance generally tracks that offered to other providers, the OIG has sought to adapt the Ambulance Guidance to the new fee schedule, to which suppliers are beginning to adjust. The Ambulance Guidance also highlights particular practices that are relevant to the disparate way in which ambulance services in general, and EMS services in particular, are made available to communities around the nation.