If Johnson & Johnson moves forward with its plan to undermine the 340B Drug Pricing Program by unilaterally imposing a rebate model rather than the longstanding upfront discount model, the Health Resources and Services Administration should take "immediate enforcement action," including assessing civil monetary penalties on Johnson & Johnson for intentionally overcharging 340B hospitals, the AHA said Aug. 28 in a letter to HRSA.
"J&J is yet again engaging in 340B vigilantism," AHA's General Counsel Chad Golder wrote. "J&J's adoption of this rebate model is yet another example of a drug company seeking to squeeze every possible penny from the hospitals and health systems that care for America's underserved patients."
On Aug. 23, J&J announced that it would be upending its approach to 340B pricing for two of its most popular products, Stelara and Xarelto. Historically, J&J offered upfront discounts to 340B hospitals when they purchase these drugs. Starting on Oct. 15, however, J&J will require all disproportionate share hospitals participating in the 340B Drug Pricing Program to purchase these drugs at full price and apply for a rebate from J&J. Under the new program, these hospitals will be required to submit certain data to J&J when they purchase the drugs at full price. After J&J verifies the drug's 340B status, it will send disproportionate share hospitals a rebate for the difference between the amount paid and the discounted 340B price.
AHA said that J&J's new policy is a fundamental shift in how the 340B program has operated for over 30 years and "could jeopardize patients' access to these drugs." In addition, disproportionate share hospitals, which already operate on the thinnest of margins, will be forced to develop pricey administrative mechanisms to make and track rebate requests.
"And J&J will essentially transform itself into the ultimate arbiter of whether a rebate should be approved and paid, with the likely consequence of J&J denying rebates to hospitals that they appropriately owe," AHA said. "While J&J may contend that this new policy is needed to improve program transparency, Congress did not permit drug companies to take the law into their own hands.... This new rebate policy — like the drug companies' contract pharmacy policies that preceded it — is a money-making scheme dressed up as a program integrity measure."
如果强生公司继续实施破坏 340B 药品定价计划的计划，单方面实施回扣模式，而不是长期存在的预付折扣模式，美国卫生资源和服务管理局 (HRSA) 应采取“立即执法行动”，包括对强生公司故意向 340B 医院收取过高费用的行为处以民事罚款，AHA 在 8 月 28 日致 HRSA 的一封信中表示。
AHA 总法律顾问 Chad Golder 写道。“强生公司采用这种回扣模式是制药公司试图从为美国服务不足的患者提供医疗服务的医院和医疗系统榨取每一分钱的又一例子。”
8 月 23 日，强生公司宣布将改变其两种最受欢迎的产品 Stelara 和 Xarelto 的 340B 定价方法。从历史上看，强生公司在购买这些药品时会向 340B 医院提供前期折扣。然而，从 10 月 15 日开始，强生公司将要求所有参与 340B 药品定价计划的不成比例份额医院以全价购买这些药品，并向强生公司申请回扣。根据新计划，这些医院在以全价购买药品时必须向强生公司提交某些数据。在强生公司核实该药品的 340B 状态后，它将向不成比例份额医院提供回扣，回扣金额为支付金额与折扣后的 340B 价格之间的差额。
AHA 表示，强生公司的新政策是 340B 计划 30 多年来运作方式的根本性转变，“可能会危及患者获得这些药品的机会。”此外，利润已经非常微薄的不成比例的医院将被迫开发昂贵的行政机制来提出和跟踪回扣请求。
“强生公司将基本上成为是否应批准和支付回扣的最终仲裁者，其可能的后果是强生公司拒绝向他们应得的医院提供回扣，”AHA 表示。“虽然强生公司可能认为这项新政策是提高计划透明度所必需的，但国会并没有允许制药公司自行制定法律……这项新的回扣政策——就像制药公司之前的合同药房政策一样——是一种伪装成计划完整性措施的赚钱计划。”
