A Comprehensive Survey of Key 注册ulations Impacting Arrangements Between 非营利医疗机构 and Physicians
医疗保健 and tax regulations require nonprofit healthcare organizations to consider fraud and abuse and private inurement issues when engaging with physicians. 收购医生拥有的实体, 就业协议, 服务协议, 许多其他安排可能涉及多个监管障碍. 遵从性需要考虑 公平市价 (FMV), commercial reasonableness (CR), and reasonable compensation (RC) when employing physicians.
无论是盈利性还是非盈利性, participation in government reimbursement programs requires organizations to comply with federal laws, 法规, 法规. 理解这些和相应的 FMV, CR, and RC requirements is key to evaluating arrangements and compliance. 如适用，也应考虑相关的州法规.
反回扣法规(AKS). 部的,[1]适用于任何人的推荐, protects patients and federal healthcare programs by making the knowing or willful exchange of renumeration in return for referrals (for services and items) illegal. 尽管这种安排的多重目的可能是合法的, if one purpose[2] of the renumeration is to improperly induce referrals, 这种安排违反了AKS。. 后果, including exclusion from federal healthcare programs and criminal and civil penalties, 可以适用于组织和个人吗. Several voluntary safe harbors require FMV and CR be met and should be principal considerations of organizations seeking to meet these safe harbors.
斯塔克法则(Stark).[3] Stark prohibits patient referrals for designated health services payable by Medicare or Medicaid to an entity with which a physician, 或者他们的直系亲属, 有经济关系. Likewise, claims for services from prohibited referrals may not be submitted for reimbursement. 作为严格的责任法规, 不需要意图证明, and violation may result in exclusion from Medicare and Medicaid plus civil (but not criminal) penalties. FMV和CR是满足若干强制性例外的要求, highlighting the importance of these considerations for compliance purposes.
商业合理性. Many of the Stark exceptions and AKS safe harbors require CR, but neither define it. CMS and the Department of Justice have provided commentary that CR means the particular arrangement furthers a legitimate business purpose of the parties and is on similar terms and conditions as like arrangements.[4]虽然一项安排可能是FMV，但它可能不是CR (e).g., multiple medical directors over a service line may be compensated at FMV, 但服务可能是重复的，因此不是CR).
公平市价. FMV是联邦法律、法规和规章的重要组成部分. Internal Revenue Ruling 59-60 defines FMV but does not reference referrals or business generated between the parties. 因此, 医疗非营利组织应该参考斯塔克名下的FMV, 它将FMV定义为公平交易的价值, 与一般市场价值一致, 不考虑转介而决定.[5] AKS does not define FMV, but several safe harbors require compensation be consistent with FMV.
Establishing FMV may require appraisers with expertise in compensation, 管理及专业服务, 营业和无形资产, 不动产, 和设备, 等.
虚假申报法(FCA). 根据FCA的规定，举报人可以提起诉讼 , tam lawsuits for false claims submitted as a result of arrangements in violation of either AKS or Stark. 举报人可能会获得部分赔偿. FCA规定的处罚是民事处罚.
协调医疗的监管冲刺. 2019年10月，美国政府宣布了一项新政策.S. Department of Health and Human Services issued proposed rules for Stark and AKS to advance the transition to value-based care, 减轻监管负担, 消除协调医疗的障碍. In many instances, the proposed revisions to Stark and AKS mirror one another. 主要的修订建议包括新的, 基于值的异常和安全港, FMV和CR的潜在新定义, 澄清基于wrvu的补偿是一种合理的方法, and clarification an arrangement may be CR even if it is not profitable. Nonprofit entities should be familiar with the proposed rules and anticipate more to come later this year.
非营利组织的规章制度强调私人保险, 超额利益交易, and RC with the risk of further penalties and potential revocation of tax-exempt status. 这些规定禁止向“内部人士”(即“内部人”)提供超额利益.e., those with substantial influence over an organization) which may include physicians.[6] To be reasonable, compensation cannot be excessive and must be properly structured.[7]超过FMV的支付可能违反这些规定. Determination of RC may contemplate amounts paid to others with similar roles and responsibilities at comparable organizations. 除了薪金和工资, nonprofit entities must also consider other forms of cash and noncash compensation (e.g.、附加福利、退休金计划、递延补偿等.).
实施最佳实践可以防止违反法规.
强调承包过程，并与之保持一致. Centralize compensation contracting oversight and formalize the process. Formal and methodical contract reviews may include CR, FMV, and RC evaluation policies. 识别高风险安排, 组织可能需要独立人员的专业知识, third-party valuator as well as consultation with in-house and outside counsel.
不断寻求理解合同组成部分和相关数据. 所有合同组成部分的要求是否可行.g.，总工作时数)? Have compensation limits been set for each component of service and for total contractual compensation? 服务是否与其他服务重复? 总报酬是否属于FMV，是否属于RC? 是否做过FMV, 如果是这样的话, what is the effective period of the valuation and when should it be updated? 当使用市场数据来支持补偿时, understand how the market compensation is calculated (may vary from source to source).
Commit to proper documentation and pay physicians according to the documentation. 要求医生记录每个角色的工作.g.，时间日志). 注册ularly audit the documentation and reconcile to services required and described in the contract.
As compensation arrangements of nonprofit healthcare organizations are under increasing regulatory scrutiny, organizations must make systematic efforts to document and comply with CR, FMV, 和RC确保遵守法规.
[1] 42 U.S.C. § 1320a-7b.
[2]美国v. 格雷伯，华氏760度.2d 68 (3d. 1985), cert. 否认, 474 U.S. 988 (1985).
[3] 42 U.S.C. § 1395nn.
[4]刘振民. 注册. 1700年(1月. 9, 1998); 69 Fed. 注册. 16093(3月. 26, 2004).
[5] 42 C.F.R § 411.351.
[6] I.R.C. § 501(c)(3).
[7] 26 C.F.R. § 53.4958-4.
