Whether for-profit or nonprofit, 参与政府报销计划要求组织遵守联邦法律, 法规, 法规. Understanding these and corresponding FMVCR和RC需求是评估安排和遵从性的关键. Related state 法规 should also be considered, as applicable.
Anti-Kickback Statute (AKS). 部的,[1] applicable to referrals from anyone, 保护患者和联邦医疗保健计划,将知情或故意换取转诊(服务和项目)的报酬定为非法行为. Even though multiple purposes for the arrangement may be legitimate, 如果报酬的目的之一[2]是不恰当地诱导转介, the arrangement violates AKS. 后果, 包括被排除在联邦医疗保健计划之外,以及受到刑事和民事处罚, can apply to organizations and individuals. 一些自愿安全港要求满足FMV和CR,这应该是寻求满足这些安全港的组织的主要考虑因素.
斯塔克法则(Stark).[3]斯塔克禁止将病人转介到由医疗保险或医疗补助支付的指定医疗服务的实体, or their immediate family member, has a financial relationship. 同样,禁止转诊的服务索赔不得提交报销. As a strict liability statute, proof of intent is not required, 违反规定可能会导致被排除在医疗保险和医疗补助计划之外,并受到民事(但不是刑事)处罚. FMV and CR are requirements to meet several mandatory exceptions, 强调这些考虑对于遵从性目的的重要性.
Commercial reasonableness. 许多明显的例外和AKS安全港都要求CR,但都没有定义它. CMS和司法部的评论认为,CR是指特定安排促进了双方的合法商业目的,并且与类似安排的条款和条件相似.[4] Although an arrangement may be FMV, it may not be CR (e.g., 同一服务线上的多名医务主任可在FMV获得补偿, but the services may be duplicative and hence not CR).
公平市价. FMV is a key element of federal laws, 法规, 法规. 《明升app》第59-60条对FMV进行了定义,但并未提及双方之间的推荐人或业务. 因此, healthcare nonprofit organizations should refer to FMV under Stark, which defines FMV as the value in arm’s-length transactions, consistent with the general market value, and determined without consideration of referrals.[5] AKS没有定义FMV,但一些安全港要求补偿与FMV一致.
建立FMV可能需要具有补偿专业知识的评估师, management and professional services, business and intangible assets, 不动产, 和设备, 等.
False Claims Act (FCA). Under the FCA, whistleblowers can file , tam 由于违反AKS或Stark的安排而提交的虚假索赔诉讼. Whistleblowers may receive a share of any recovery. Penalties under the FCA are civil.
注册ulatory Sprint to Coordinated Care. In October 2019, the U.S. 卫生与公众服务部发布了斯塔克和AKS的拟议规则,以推进向基于价值的护理的过渡, ease regulatory burdens, and remove barriers to coordinated care. 在许多情况下,对Stark和AKS的拟议修订是相互镜像的. Key proposed revisions include new, value-based exceptions and safe harbors, potential new definitions of FMV and CR, clarification of wRVU-based compensation as a reasonable method, 澄清一个安排可能是CR,即使它不盈利. 非营利机构应该熟悉拟议的规则,并预计今年晚些时候将出台更多规则.