Liang F Z, Black B L
Am J Hosp Pharm. 1991 Nov;48(11):2434-7.
Specific business arrangements that are protected under legislation and regulations governing parties doing business with Medicare or Medicaid are discussed. Regulations implementing the Medicare and Medicaid Patient Protection Act of 1987 specify practices and activities that are not subject to criminal penalties under the antikickback provisions of the Social Security Act or to exclusion from Medicare or state health-care programs. As of July 29, 1991, all organized health-care settings that receive payments from either Medicare or state health-care programs must comply with these regulations. The final rule sets forth "safe harbors"--exceptions to prohibitions against (1) kickbacks, bribes, rebates, and other illegal activities involving remunerations for patient referrals and (2) inducements to purchase or lease goods paid for by Medicare or state health-care programs. The safe harbors comprise 11 broad categories--investment interests, space rental, equipment rental, personal services and management contracts, purchase of a medical practice, referral services, warranties, discounts, employees, group purchasing organizations, and waiver of deductibles and coinsurance. Implications for pharmacy are discussed. These regulations will affect the purchase of pharmaceuticals by institutional pharmacies. Each institution should review its current practices to determine whether they are within the safe harbors.
本文讨论了受与医疗保险或医疗补助计划相关方的法律法规保护的特定商业安排。1987年《医疗保险和医疗补助患者保护法》的实施条例规定了一些做法和活动，这些做法和活动不受《社会保障法》反回扣条款的刑事处罚，也不受医疗保险或州医疗保健计划的排除。截至1991年7月29日，所有从医疗保险或州医疗保健计划获得付款的有组织医疗保健机构都必须遵守这些规定。最终规则规定了“安全港”——即对以下两类禁止行为的例外情况：（1）回扣、贿赂、回扣以及其他涉及为患者转诊支付报酬的非法活动；（2）诱导购买或租赁由医疗保险或州医疗保健计划支付费用的商品。安全港包括11大类——投资利益、空间租赁、设备租赁、个人服务和管理合同、医疗业务收购、转诊服务、保修、折扣、员工、集团采购组织以及免赔额和共保的豁免。本文还讨论了对药学的影响。这些规定将影响机构药房的药品采购。每个机构都应审查其当前做法，以确定它们是否在安全港范围内。
