AKS Safe Harbor Term |
Definition |
Coordination and management of care (or coordinating and managing care) |
Means the deliberate organization of patient care activities and sharing of information between two or more VBE participants, one or more VBE participants and the VBE, or one or more VBE participants and patients, that is designed to achieve safer, more effective, or more efficient care to improve the health outcomes of the target patient population. |
Digital health technology |
Means hardware, software, or services that electronically capture, transmit, aggregate, or analyze data and that are used for the purpose of coordinating and managing care; such term includes any internet or other connectivity service that is necessary and used to enable the operation of the item or service for that purpose. Limited technology participant |
Limited technology participant |
Means a VBE participant that exchanges digital health technology with another VBE participant or a VBE and that is:
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- A manufacturer of a device or medical supply, but not including a manufacturer of a device or medical supply that was obligated under 42 CFR § 403.906 to report one or more ownership or investment interests held by a physician or an immediate family member during the preceding calendar year, or that reasonably anticipates that it will be obligated to report one or more ownership or investment interests held by a physician or an immediate family member during the present calendar year (for purposes of this paragraph, the terms “ownership or investment interest,” “physician,” and “immediate family member” have the same meaning as set forth in 42 CFR § 403.902); or
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- An entity or individual that sells or rents durable medical equipment, prosthetics, orthotics, or supplies covered by a Federal health care program (other than a pharmacy or a physician, provider, or other entity that primarily furnishes services).
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Manufacturer of a device or medical supply |
Means an entity that meets the definition of applicable manufacturer in 42 CFR § 403.902 because it is engaged in the production, preparation, propagation, compounding, or conversion of a device or medical supply that meets the definition of covered drug, device, biological, or medical supply in 42 CFR § 403.902, but not including entities under common ownership with such entity. |
Target patient population |
Means an identified patient population selected by the VBE or its VBE participants using legitimate and verifiable criteria that:
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- Are set out in writing in advance of the commencement of the value-based arrangement; and
- Further the value-based enterprise’s value-based purpose(s).
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Value-based activity |
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- Means any of the following activities, provided that the activity is reasonably designed to achieve at least one value-based purpose of the value-based enterprise:
- The provision of an item or service;
- The taking of an action; or
- The refraining from taking an action; and
- Does not include the making of a referral.
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Value-based arrangement |
Means an arrangement for the provision of at least one value-based activity for a target patient population to which the only parties are:
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- The value-based enterprise and one or more of its VBE participants; or
- VBE participants in the same value-based enterprise.
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Value-based enterprise or VBE |
Means two or more VBE participants:
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- Collaborating to achieve at least one value-based purpose;
- Each of which is a party to a value-based arrangement with the other or at least one other VBE participant in the value-based enterprise;
- That have an accountable body or person responsible for financial and operational oversight of the value-based enterprise; and
- That have a governing document that describes the value-based enterprise and how the VBE participants intend to achieve its value-based purpose(s).
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Value-based enterprise participant or VBE participant |
Means an individual or entity that engages in at least one value-based activity as part of a value-based enterprise, other than a patient acting in their capacity as a patient. |
Value-based purpose |
Means:
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- Coordinating and managing the care of a target patient population; Improving the quality of care for a target patient population;
- Appropriately reducing the costs to or growth in expenditures of payors without reducing the quality of care for a target patient population; or
- Transitioning from health care delivery and payment mechanisms based on the volume of items and services provided to mechanisms based on the quality of care and control of costs of care for a target patient population.
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