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Stark
[No comparable exception]
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Anti-Kickback
Safe harbor for patient engagement and support and CMS sponsored models 42 CFR 1001.952(hh)
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Remuneration does not include patient engagement tools or support furnished by a VBE participant to a patient in the target patient population of a value-based arrangement to which the VBE participant is a party
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The VBE participant is not:
(i) A pharmaceutical manufacturer, distributor, or wholesaler;
(ii) A pharmacy benefit manager;
(iii) A laboratory company;
(iv) A pharmacy that primarily compounds drugs or primarily dispenses compounded drugs;
(v) A manufacturer of a device or medical supply, unless the patient engagement tool or support is digital health technology;
(vi) 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, a manufacturer of a device or medical supply, or a physician, provider, or other entity that primarily furnishes services);
(vii) A medical device distributor or wholesaler that is not otherwise a manufacturer of a device or medical supply; or
viii) 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, even if the patient engagement tool or support is digital health technology (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).
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The patient engagement tool or support is furnished directly to the patient (or the patient's caregiver, family member, or other individual acting on the patient's behalf) by a VBE participant that is a party to the value-based arrangement or its eligible agent.
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The patient engagement tool or support:
(i) Is an in-kind item, good, or service;
(ii) That has a direct connection to the coordination and management of care of the target patient population;
(iii) Does not include any cash or cash equivalent;
(iv) Does not result in medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program;
(v) Is recommended by the patient's licensed health care professional; and
(vi) Advances one or more of the following goals:
(A) Adherence to a treatment regimen determined by the patient's licensed health care professional.
(B) Adherence to a drug regimen determined by the patient's licensed health care professional.
(C) Adherence to a followup care plan established by the patient's licensed health care professional.
(D) Prevention or management of a disease or condition as directed by the patient's licensed health care professional.
(E) Ensure patient safety.
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The patient engagement tool or support is not funded or contributed by:
(i) A VBE participant that is not a party to the applicable value-based arrangement; or
(ii) An entity listed in the safe harbor as being excluded from being a VBE participant for purposes of this safe harbor.
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The aggregate retail value of patient engagement tools and supports furnished to a patient by a VBE participant on an annual basis does not exceed $500, adjusted annually
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The VBE participant or any eligible agent does not exchange or use the patient engagement tools or supports to market other reimbursable items or services or for patient recruitment purposes.
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For a period of at least 6 years, the VBE participant makes available to the Secretary, upon request, all materials and records sufficient to establish that the patient engagement tool or support was distributed in a manner that meets the conditions of this paragraph.
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The availability of a tool or support is not determined in a manner that takes into account the type of insurance coverage of the patient.
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For purposes of this paragraph, the following definitions apply:
(i) Eligible agent means any person or entity that is not identified in the safe harbor as being excluded from being a VBE participant for purposes of this safe harbor.
(ii) Coordination and management of care, target patient population, value-based arrangement, VBE, VBE participant, manufacturer of a device or medical supply, and digital health technology shall have the meaning set forth in the care coordination arrangements safe harbor, 42 CFR 1001.952(ee).
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