医疗保险和医疗补助服务中心的正压通气依从性标准可能会限制许多 Medicare 受益人的治疗。
Centers for Medicare and Medicaid Services Positive Airway Pressure Adherence Criteria May Limit Treatment to Many Medicare Beneficiaries.
机构信息
Pulmonary, Critical Care and Sleep Medicine, Geisinger Health System, Wilkes-Barre, Pennsylvania.
Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.
出版信息
J Clin Sleep Med. 2019 Feb 15;15(2):245-251. doi: 10.5664/jcsm.7626.
STUDY OBJECTIVES
Centers for Medicare and Medicaid Services (CMS) reimbursement for positive airway pressure (PAP) devices for obstructive sleep apnea treatment is dependent on patients meeting adherence expectations within the first 3 months on therapy. Adherence is defined as usage of the device for at least 4 hours per night on 70% of nights during a consecutive 30-day period. We hypothesize that the adherence pattern may be established beyond this initial period, which may limit the opportunity to treat many patients.
METHODS
Treatment and adherence data from PAP devices were monitored via wireless modems for 42 consecutive PAP-naïve military veterans who completed 1 year of nightly monitoring. Their baseline characteristics were as follows: age (mean ± standard deviation) 58.5 ± 12.5 years; body mass index 33.7 ± 5.7 kg/m; diagnostic apnea-hypopnea index (pretreatment) 28.1 ± 18.5 events/h; apnea-hypopnea index on PAP: 4.3 ± 3.3 events/h. We examined daily, monthly, quarterly, semiannual, and annual reports, and the best 30-day adherence report for each quarter.
RESULTS
In the first 3 months, 19 of 42 participants were adherent by CMS criteria, and 23 of 42 participants were not. Of the 19 adherent participants, 13 remained adherent and 6 became nonadherent or stopped PAP treatment for the remainder of the year. In the 23 initially nonadherent participants, 16 stopped PAP treatment, and 7 participants (30.4%) became adherent (using CMS criteria) during the rest of the year. Thus, PAP adherence during the first 3 months was predictive for the rest of the year in only 68.4%. PAP nonadherence during the first 3 months was predictive for further nonadherence in only 69.6% of the cases. Overall, this led to a 65% sensitivity and 72% specificity of using adherence at 3 months in predicting adherence at 1 year.
CONCLUSIONS
CMS adherence criteria affecting PAP coverage are restrictive and can result in the withholding of therapy in many patients who otherwise might become adherent.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov, Title: Remote Monitoring in Obstructive Sleep Apnea, Identifier: NCT01678560, URL: https:// clinicaltrials.gov/ct2/show/NCT01678560.
研究目的
医疗保险和医疗补助服务中心（CMS）对阻塞性睡眠呼吸暂停治疗的正压通气（PAP）设备的报销取决于患者在治疗的前 3 个月内达到预期的依从性。依从性定义为在连续 30 天的时间内，每晚使用设备至少 4 小时，且在 70%的夜晚使用。我们假设这种依从模式可能在最初的时间段之后建立，这可能限制了治疗许多患者的机会。
方法
通过无线调制解调器监测 42 名连续 PAP 治疗初治的退伍军人的治疗和依从性数据，这些患者完成了 1 年的夜间监测。他们的基线特征如下：年龄（平均值±标准差）58.5±12.5 岁；体重指数 33.7±5.7kg/m；诊断性睡眠呼吸暂停低通气指数（治疗前）28.1±18.5 次/小时；PAP 上的呼吸暂停低通气指数：4.3±3.3 次/小时。我们检查了每日、每月、每季度、每半年和每年的报告，以及每个季度最佳的 30 天依从性报告。
结果
在前 3 个月中，42 名参与者中有 19 名符合 CMS 标准的依从性，而 42 名参与者中有 23 名不符合。在 19 名依从性的参与者中，13 名仍保持依从性，6 名变为不依从或停止 PAP 治疗。在最初的 23 名不依从性参与者中，16 名停止 PAP 治疗，7 名（30.4%）在其余的时间内变得依从（使用 CMS 标准）。因此，在前 3 个月的 PAP 依从性仅能预测接下来一年中的 68.4%。在前 3 个月的 PAP 不依从性仅能预测接下来一年中进一步不依从的 69.6%。总体而言，这导致在前 3 个月使用依从性预测 1 年依从性的敏感性为 65%，特异性为 72%。
结论
影响 PAP 覆盖范围的 CMS 依从性标准具有限制性，可能导致许多原本可能依从的患者无法接受治疗。
临床试验注册
注册机构：ClinicalTrials.gov，标题：阻塞性睡眠呼吸暂停的远程监测，标识符：NCT01678560，网址：https://clinicaltrials.gov/ct2/show/NCT01678560。
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