美国联邦医疗保险要求专家权衡低剂量CT肺癌筛查

美国联邦医疗保险（Medicare）是否应当为特定患者接受计算机断层扫描（CT）肺癌筛查买单？一个专家顾问组于4月30日举行会议，分析证据并提出建议。

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Medicare & Medicaid服务中心（CMS）已接受了两项正式请求，开始分析全国低剂量CT（LDCT）肺癌筛查覆盖率。CMS明确要求其下属的Medicare证据发展与覆盖顾问委员会（MEDCAC）讨论下列事宜：

·可识别出筛查获益最大的Medicare患者的证据。

·筛查频率和持续时间。

·可使获益最优化、伤害最小化的筛查提供者特征。

·可确定检查结果阳性和假阳性结果影响的标准。

·随访检查或治疗。

CMS还试图了解，在Medicare获益人（包括老年人、较年轻的残疾人、终末期肾病患者，以及正在接受综合戒烟干预的目前吸烟者）中，这些因素将会对患者教育和知情同意产生怎样的影响。

去年12月份，美国预防服务工作组（USPSTF）建议，年龄55~80岁、有30包/年吸烟史的目前吸烟者或戒烟不足15年者应每年接受LDCT肺癌筛查。根据推荐意见，一旦戒烟达到15年或因出现健康问题而导致预期寿命缩短或难以接受治愈性肺部手术，则应停止筛查。

USPSTF的建议在很大程度上是基于一篇纳入2000~2013年期间若干项随机对照试验（包括全国肺部筛查试验）的系统综述。该研究纳入了超过50,000名无症状、年龄55~74岁的成人，结果显示接受LDCT筛查者的肺癌死亡率降低了16%，全因死亡率降低了6.7%。每筛查320人可避免1例肺癌死亡，每筛查219人可避免1例全因死亡。

CMS认为，要作出在全国覆盖预防服务的决定，需满足下列条件：预防或早期发现某种疾病或残疾是合理且必需的；USPSTF的A级或B级建议；适用于Medicare的A类或B类获益人。

CMS已要求该专家组投票决定，是否有足够证据表明LDCT肺癌筛查的获益超过伤害。CMS特别询问了，是否有足够证据表明LDCT在下列情况下能够改善健康转归：在无症状、年龄超过74岁的高风险成人中；每年进行3次以上的LDCT筛查；在临床研究之外实施筛查计划。

CMS还要求专家组权衡LDCT肺癌筛查在Medicare人群中造成的伤害，具体包括扫描本身（平均剂量为1.5 mSv）、对肺内和肺外进行随访评估，以及阳性和假阳性结果引起的治疗所带来的伤害。CMS还将要求专家组确定和讨论，在临床试验之外采用LDCT进行肺癌筛查方面是否存在任何有临床意义的差异。

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By: REBECCA KERN, Oncology Practice Digital Network

Should Medicare pay for low-dose computed tomography to screen certain patients for lung cancer? A panel of expert advisers will meet April 30 to review the evidence and make a recommendation.

The Centers for Medicare & Medicaid Services has accepted two formal requests to initiate a national coverage analysis on lung cancer screening with low-dose computed tomography (LDCT), which the U.S. Preventative Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

CMS is specifically asking its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss:

• the evidence that identifies which Medicare patients would benefit the most from the screening.

• screening frequency and duration.

• provider characteristics that optimize benefits and minimize harm.

• criteria to identify a test as positive and the impact of false-positive results.

• follow-up tests or treatments.

The agency also seeks to know how these factors will impact patient education and informed consent in Medicare beneficiaries, including the elderly, younger disabled populations, and patients with end-stage renal disease, and on integrating smoking cessation interventions for current smokers.

In order for CMS to issue a national coverage determination for a preventive service, the following criteria must be met: reasonable and necessary for prevention or early detection of an illness or disability; an A- or B-grade recommendation from USPSTF; and appropriate for Medicare Part A or Medicare Part B beneficiaries.

CMS has asked the panel to vote on whether there is adequate evidence to determine if the benefits of lung cancer screening with LDCT outweigh the harms. The agency will specifically ask if there is adequate evidence to determine if LDCT improves health outcomes: in asymptomatic, high-risk adults over 74 years old; with more than three annual LDCT screens; and if the screening program is implemented outside a clinical study.

The agency is also asking for panel input on the harms of lung cancer screening with LDCT in the Medicare population, specifically harms from the scan itself (an average dose of 1.5 mSv), harms from follow-up evaluation of findings in and outside the lungs, and harms from treatment as a result of positive and false-positive results.

CMS will also ask the panel to identify and discuss any clinically significant evidence gaps regarding the use of LDCT in lung cancer screening outside of a clinical trial.

Last December, the USPSTF recommended annual screening for lung cancer with LDCT in adults aged 55- 80 years who have a 30-pack-year smoking history and currently smoke or have quit in the past 15 years. The recommendation states that screening should be stopped once a person has stopped smoking for 15 years or develops a health problem limiting life expectancy or the ability to have curative lung surgery.

The USPSTF’s recommendations were based largely on a systematic review of several randomized, controlled trials published between 2000 and 2013, including the National Lung Screening Trial. That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT. One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

Under the Affordable Care Act, insurers are required to cover, with no copay requirements, preventative care and screening services that receive a grade A or grade B recommendation from USPSTF.