华盛顿远程医疗规则

上周,,联邦地方法院卫生与公众服务部(HHS)的秘书在必威官网betbetway体育app减少医疗保险门诊预期支付系统(OPPS)报销对于340B计划下购买的大多数单独支付的药物,医院的支付率接近30%。之后第二次开庭的法院the first lawsuit was dismissed for being premature-决定其现在拥有标的物管辖权,因为已提出付款要求。On the merits,法院站在原告一边,认为卫生和公众服务部部长有权调整“reimbursement rates does not justify"基本和基本变化”对单独支付的药物的OPPS补偿方法。

法院的裁决是原告和340家医院的重大胜利,可能会进一步挑战CMS的OPPS规则,包括对有争议的医疗保险的挑战site-neutrality付款调整。然而,340B家医院将需要等待,以确定他们可以获得哪些财政救济。尤其是,法院批准了原告的永久性强制令请求,但裁定无法决定强制令的实施方式,或原告有权获得的其他救济(包括经济补偿);直到收到各方的进一步简报。必威体育网站a quagmire that may be impossible to navigate,“部分原因是,340亿美元的削减是以预算中立的方式实施的,意味着受影响340B药物的付款减少增加了医疗保险OPPS下其他服务和非340B医院的付款。因此,betway体育app法院正在考虑的救济可能包括对所有Opps提供商的付款调整。

法院的命令要求在30天内就适当的补救措施提供补充简报,并指示各方在补充简报提交后14天内提供答复简报。未来的裁决将决定法院命令将产生什么后果,and may line up further appeals of the court's decision to the D.C.巡回法庭

进一步用尽补救措施将是徒劳的,法庭说

作为一个基本问题,the court's rejection of the procedural arguments raised by HHS against review represents a considerable victory for plaintiffs.在第一轮诉讼中,the government asserted that plaintiffs were not entitled to bring their claims in court because they had not exhausted their administrative remedies as required by 42 U.S.C.第405(g)条。这一次,地方法院不同意禁止索赔。

法院首先注意到,原告提出了利益要求,从而有意义地改变了他们的立场,thereby meeting the jurisdictional first element of Section 405(g).  The court then reasoned that it could waive the second element—that the administrative remedies prescribed by the Secretary be exhausted—because it was"很明显”在这种情况下,需要精疲力竭是徒劳的。法院认为,该案提出的纯粹是法律问题特别有说服力,没有理由相信卫生和公众服务部会改变主意,因为它已经考虑并驳回了原告在年提出的法律论点。通知和评论程序与规章的修订有关。正如法院另外观察到的,卫生和公众服务部也没有对此提出异议。”任何行政审查机构都无权改变或偏离。”from the final rule's requirement,特别明确行政救济的无效性。

医疗保险法不能取消对越权行为索赔

政府还辩称,《医疗保险法》中的具体规定排除了司法审查340B种药物的Opps价格调整。法院拒绝解决双方在这一点上的法定解释冲突。相反,它依据的原则是,医疗保险法对司法审查的排除可以延长不超过秘书的法定授权审查中的调整。正如法院解释的,特区判例法巡回法院明确表示,即使在机构采取行动时,法律禁止根据《行政程序法》进行司法审查的情况下,也可以进行司法审查。越权行为,或超过法定权限。越权行为review as a narrow exception that allows otherwise unchallengeable agency action to be reviewed when it represents a patent violation of agency authority,the Court turned to an analysis on the merits with the understanding that a substantive finding that the Secretary plainly exceeded his statutory authority would mean that the court was not precluded from judicial review.

“Adjustment"Authority Is Not Plenary Power to Change Rates

关于案情的争论的关键在于部长是否有权调整“平均销售价格(ASP)加上6%的基准药物偿付率,使他有权将340亿种药物的偿付率降至ASP减去22.5%。具体的“调整“被选中根据Medpac对340亿药物医院采购成本的估计.  The court dismissed the Secretary's argument that his adjustment sought to mimic an alternative statutory reimbursement formula based on acquisition costs;在法庭看来,“the statutory scheme is clear that if the Secretary does not have [the necessary] data"以购置成本为基础进行补偿,“他必须参照药物计算报销率。average sales price.““

法院的底线是”利率下调的幅度及其广泛适用性必然导致部长从根本上改变了国会制定的法定方案。”and thereby exceeded his"调整“权威。

国会对政策有最后决定权

诉讼和CMS的OPPS削减都是在关于340B计划范围和未来的持续争议的背景下发起的。在其决定中,必威体育网站法院承认卫生和公众服务部对340B计划和340B药品的支付表示政策关注,包括该机构认为,340亿药物医院的巨大利润率导致了不必要的使用,that rising prices for certain drugs have unfairly increased cost sharing for Medicare beneficiaries,这就是“inappropriate for Medicare to subsidize other activities through Medicare payments for separately payable drugs."Ultimately,然而,这些论点对法院没有影响,写下了这句话”国会很可能会选择不同于其他单独支付的药物的医疗保险补偿来处理340B药物的医疗保险补偿,但事实并非如此。”注意到秘书有权选择收集必要的数据,以根据购置成本确定付款率,或提出其与国会的政策分歧,法院批评了它所认为的企图结束国会的明确任务。”“

下一步是什么??

Both 340B and non-340B hospitals should carefully monitor how these remedies are applied,as the relief has the potential to redistribute billions of dollars in revenue among Medicare-participating hospitals.  The court's ruling is likely to also affect the additional cuts CMS for 340B hospitals that CMS has included in2019 OPPS,并且可能增加国会通过立法解决340B计划的压力。法院的救济裁决一经下达,该决定可向美国哥伦比亚特区上诉法院提出上诉。