Supplementary Material for: What is “advanced” Parkinson’s disease? Defining what determines Medicare coverage for deep brain stimulation in the United States

Background: The National Coverage Determination (NCD) by the Center for Medicare and Medicaid Services (CMS) for deep brain stimulation requires that a patient have “advanced idiopathic Parkinson’s disease (PD) as determined by Hoehn and Yahr (HY) stage or the Unified Parkinson’s Disease Rating Scale part III motor subscale (UPDRS III).” How to apply the HY or UPDRS III scales to define “advanced” PD is unclear.
Summary: There is an ongoing recovery audit by the CMS of deep brain stimulation cases that were covered by Medicare but are deemed not to have met the NCD requirements and therefore not to have been medically necessary. Whether a hospital is asked to refund Medicare often hinges upon whether medical documentation supports the diagnosis of advanced PD. However, neither the HY nor the UPDRS III scales use “advanced” to define or describe stages of PD. The NCD has an accompanying National Coverage Analysis that reviews the studies that inform the NCD. These studies use “advanced” as well as the HY and UPDRS III scales. This review identifies how the HY and UPDRS III scales were used to categorize advanced PD in the studies that were cited in the National Coverage Analysis.
Key Messages: In the studies used for the NCD for deep brain stimulation for PD, an HY score ≥3 or a UPDRS III score ≥30 was used to describe patient cohorts considered to have advanced PD.

背景：美国医疗保险和医疗补助服务中心（Center for Medicare and Medicaid Services, CMS）针对脑深部电刺激（deep brain stimulation）制定的医保覆盖范围判定（National Coverage Determination, NCD）要求患者罹患“经霍恩-亚尔（Hoehn and Yahr, HY）分期或统一帕金森病评定量表第三部分运动分项（Unified Parkinson’s Disease Rating Scale part III motor subscale, UPDRS III）评估为进展期特发性帕金森病（idiopathic Parkinson’s disease, PD）”。目前尚未明确如何通过HY分期或UPDRS III量表界定“进展期”帕金森病。
摘要：目前CMS正对一批符合既往医保覆盖政策的脑深部电刺激病例开展追溯审计：此类病例被认定未满足NCD要求，因此不属于医学必需的诊疗项目。医院是否被要求向医保基金退款，通常取决于医疗文书是否能够支撑进展期帕金森病的诊断。但HY分期与UPDRS III量表均未使用“进展期”一词来定义或描述帕金森病的分期。该NCD配套有医保覆盖分析报告，旨在梳理支撑该判定的相关研究；此类研究中同时使用了“进展期”表述以及HY、UPDRS III量表。本综述明确了医保覆盖分析报告引用的研究中，如何通过HY分期与UPDRS III量表对进展期帕金森病进行分类。
核心结论：在支撑帕金森病脑深部电刺激治疗NCD的相关研究中，学界采用HY评分≥3分或UPDRS III评分≥30分，来界定被纳入进展期帕金森病患者队列的人群。