Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Ambulance Replenishing

Stark
[No comparable exception]

Anti-Kickback
Safe harbor for all ambulance replenishing programs

The ambulance that is replenished must be used to provide emergency ambulance services an average of three times per week, as measured over a reasonable period of time. Drugs and medical supplies (including linens) initially used by a first responder and replenished at the scene of the illness or injury by the ambulance provider that transports the patient to the hospital or other receiving facility will be deemed to have been used by the ambulance provider.

Under no circumstances may the ambulance provider (or first responder) and the receiving facility both bill for the same replenished drug or supply. Replenished drugs or supplies may only be billed (including claiming bad debt) to a Federal health care program by either the ambulance provider (or first responder) or the receiving facility.

All billing or claims submission by the receiving facility, ambulance provider or first responder for replenished drugs and medical supplies used in connection with the transport of a Federal health care program beneficiary must comply with all applicable Federal health care program payment and coverage rules and regulations. Compliance with this paragraph will be determined separately for the receiving facility and the ambulance provider (and first responder, if any), so long as the receiving facility, ambulance provider (or first responder) refrains from doing anything that would impede the other party or parties from meeting their obligations under this paragraph.

The receiving facility or ambulance provider, or both, must: a) maintain records of the replenished drugs and medical supplies and the patient transport to which the replenished drugs and medical supplies related; b) provide a copy of such records to the other party within a reasonable time (unless the other party is separately maintaining records of the replenished drugs and medical supplies); and c) make those records available to the Secretary of HHS promptly upon request. A pre-hospital care report (including, but not limited to, a trip sheet, patient care report or patient encounter report) prepared by the ambulance provider and filed with the receiving facility will meet the requirements of this paragraph, provided that it documents the specific type and amount of medical supplies and drugs used on the patient and subsequently replenished. For purposes of this paragraph, documentation may be maintained and, if required, filed with the other party in hard copy or electronically. If a replenishing arrangement includes linens, documentation need not be maintained for their exchange. If documentation is not maintained for the exchange of linens, the receiving facility will be presumed to have provided an exchange of comparable clean linens for soiled linens for each ambulance transport of a patient to the receiving facility. Records required under this section must be maintained for 5 years.

The replenishing arrangement must not take into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under any Federal health care program (other than the referral of the particular patient to whom the replenished drugs and medical supplies were furnished.

The receiving facility and the ambulance provider otherwise comply with all Federal, State, and local laws regulating ambulance services, including, but not limited to, emergency services, and the provision of drugs and medical supplies, including, but not limited to, laws relating to the handling of controlled substances.

The arrangement must satisfy all of the standards in one of three categories: general replenishing, fair market value replenishing, or government-mandated replenishing.

A receiving facility is a hospital or other facility that provides emergency medical services. An ambulance provider is a provider or supplier of ambulance transport services that provides emergency ambulance services. The term does not include a provider of ambulance transport services that provides only non-emergency transport services. A first responder includes, but is not limited to, a fire department, paramedic service or search and rescue squad that responds to an emergency call (through 911 or other emergency access number) and treats the patient, but does not transport the patient to the hospital or other receiving facility. An emergency ambulance service is a transport by ambulance initiated as a result of a call through 911 or other emergency access number or a call from another acute care facility unable to provide the higher level care required by the patient and available at the receiving facility. Medical supplies includes linens, unless otherwise provided.

Stark
[No comparable exception]

Anti-Kickback
Safe harbor for ambulance replenishing programs - General replenishing

The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements.

The receiving facility must replenish medical supplies or drugs on an equal basis for all ambulance providers that bring patients to the receiving facility in any one of the following categories: a) all ambulance providers that do not bill any patient or insurer (including Federal health care programs) for ambulance services, regardless of the payor or the patient's ability to pay (i.e., ambulance providers, such as volunteer companies, that provide ambulance services without charge to any person or entity); b) all not-for-profit and State or local government ambulance service providers (including, but not limited to, municipal and volunteer ambulance services providers); or c) all ambulance service providers.

A receiving facility may offer replenishing to one or more of the categories and may offer different replenishing arrangements to different categories, so long as the replenishing is conducted uniformly within each category. For example, a receiving facility may offer to replenish a broader array of drugs or supplies for ambulance providers that do no not charge for their services than for ambulance providers that charge for their services. Within each category, the receiving facility may limit its replenishing arrangements to the replenishing of emergency ambulance transports only.

The replenishing arrangement must be conducted in an open and public manner. A replenishing arrangement will be considered to be conducted in an open and public manner if one of the following two conditions are satisfied: a) a written disclosure of the replenishing program is posted conspicuously in the receiving facility's emergency room or other location where the ambulance providers deliver patients and copies are made available upon request to ambulance providers, Government representatives, and members of the public (subject to reasonable photocopying charges). The written disclosure can take any reasonable form and should include the category of ambulance service providers that qualifies for replenishment; the drugs or medical supplies included in the replenishment program; and the procedures for documenting the replenishment. No written contracts between the parties are required; or b) the replenishment arrangement operates in accordance with a plan or protocol of general application promulgated by an Emergency Medical Services (EMS) Council or comparable entity, agency or organization, provided a copy of the plan or protocol is available upon request to ambulance providers, Government representatives and members of the public (subject to reasonable photocopying charges). While parties are encouraged to participate in collaborative, comprehensive, community-wide EMS systems to improve the delivery of EMS in their local communities, nothing in this paragraph shall be construed as requiring the involvement of such organizations or the development or implementation of ambulance replenishment plans or protocols by such organizations.

Disclosure of confidential proprietary or financial information related to the replenishing arrangement (including, but not limited to, information about cost, pricing or the volume of replenished drugs or supplies) to ambulance providers or members of the general public is not required.

Stark
[No comparable exception]

Anti-Kickback
Safe harbor for fair market value ambulance replenishing programs

The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements

The ambulance provider must pay the receiving facility fair market value, based on an arms-length transaction, for replenished medical supplies.

If payment is not made at the same time as the replenishing of the medical supplies, the receiving facility and the ambulance provider must make commercially reasonable payment arrangements in advance.

Stark
[No comparable exception]

Anti-Kickback
Safe harbor for government mandated ambulance replenishing programs

The arrangement meets all of the requirements for applicable to all ambulance restocking arrangements.

The replenishing arrangement is undertaken in accordance with a State or local statute, ordinance, regulation or binding protocol that requires hospitals or receiving facilities in the area subject to such requirement to replenish ambulances that deliver patients to the hospital with drugs or medical supplies (including linens) that are used during the transport of that patient.