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Sen. Raphael Warnock, a sponsor of RESULTS.

参议员拉斐尔·沃诺克，RESULTS 的发起人。

NEW YORK — Congress on Wednesday introduced legislation that aims to reform the Protecting Access to Medicare Act by using a third-party database of private payor claims to establish Medicare payment rates for laboratory tests.

纽约 —— 周三，国会提出了一项立法，旨在通过使用第三方私人支付方索赔数据库来确定实验室测试的医疗保险支付费率，从而改革《保护医疗保险准入法》。

Titled the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, the bill would address the challenge of obtaining representative private payor lab reimbursement data, an issue that has hampered implementation of PAMA from the beginning.

这项名为《改革和加强实验室检测服务的可持续更新》（RESULTS）法案，旨在解决获取具有代表性的私人支付方实验室报销数据的挑战，这个问题从一开始就阻碍了PAMA的实施。

The RESULTS Act was introduced in the House of Representatives by Reps. Richard Hudson, R-N.C., Gus Bilirakis, R-Fla., Brian Fitzpatrick, R-Pa., Raja Krishnamoorthi, D-Ill., and Scott Peters, D-Calif., and in the Senate by Sens. Thom Tillis, R-N.C., and Raphael Warnock, D-Ga.

RESULTS法案由众议员理查德·哈德森（北卡罗来纳州共和党）、古斯·比利亚拉基斯（佛罗里达州共和党）、布赖恩·菲茨帕特里克（宾夕法尼亚州共和党）、拉贾·克里希纳穆尔蒂（伊利诺伊州民主党）和斯科特·彼得斯（加利福尼亚州民主党）在众议院提出，并由参议员汤姆·蒂利斯（北卡罗来纳州共和党）和拉斐尔·沃诺克（佐治亚州民主党）在参议院提出。

The new legislation would significantly revamp the process for establishing Medicare reimbursement rates for lab testing.

新立法将大幅改革确定实验室检测的医疗保险报销费率的流程。

Passed in 2014 and implemented in 2018 with an initial round of data reporting and price cuts, PAMA aimed to control Medicare spending on laboratory testing by basing its reimbursement rates on private payor rates, which were typically lower. The law required laboratories to collect and report data on payments received from private insurers, which was then used by Medicare to set its test reimbursement rates..

2014年通过并在2018年实施了初步的数据报告和价格削减，PAMA旨在通过基于私人支付方的费率来控制医疗保险在实验室检测上的支出，这些费率通常较低。该法律要求实验室收集并报告从私人保险公司收到的付款数据，然后由Medicare用这些数据来设定其测试报销费率。

The lab industry was broadly opposed to the law with a primary complaint being that much of the lab payment data was coming from large national laboratories, which typically receive lower reimbursement from private payors than do hospital and smaller independent labs. This, the industry claimed, led to inappropriately low Medicare payment rates under PAMA.

实验室行业普遍反对该法律，主要抱怨是大部分实验室支付数据来自大型全国性实验室，这些实验室通常从私人支付方获得的报销比医院和较小的独立实验室低。行业声称，这导致根据PAMA制定的医疗保险支付费率过低。

The US Centers for Medicare and Medicaid Services (CMS) also declined to enforce the law's reporting requirements by levying the penalties, including fines, available to it..

美国医疗保险和医疗补助服务中心 (CMS) 也拒绝通过实施包括罚款在内的处罚来强制执行法律的报告要求。

Aiming to reform the law, Congress in 2022 introduced the

旨在改革法律，国会在2022年推出了

Saving Access to Laboratory Services Act (

保存实验室服务准入法案 (

SALSA), which would have instituted a statistical sampling-based approach to collecting lab test pricing data under PAMA. Proponents claimed SALSA would both alleviate the administrative burden on labs and ensure that price data is collected from a more representative slice of the industry.

SALSA），该法案将根据PAMA采用基于统计抽样的方法来收集实验室测试定价数据。支持者声称，SALSA既可减轻实验室的行政负担，又能确保从更具行业代表性的部分收集价格数据。

Congress did not pass SALSA, however, choosing instead to pass a series of one-year delays to PAMA implementation. Some in the industry have suggested the bill struggled in part due to the complexity of its statistical sampling-based approach as well as its continued reliance on lab-reported price data.

然而，国会并未通过SALSA法案，而是选择了一系列为期一年的PAMA实施延迟。行业中的有些人认为，该法案之所以遇到困难，部分原因在于其基于统计抽样的方法过于复杂，并且仍然依赖实验室报告的价格数据。

Over the last year, stakeholders including the American Clinical Laboratory Association (ACLA) and the College of American Pathologists (CAP) have .

在过去的一年中，包括美国临床实验室协会（ACLA）和美国病理学家学会（CAP）在内的利益相关者已经。

indicated they were

表明他们是

exploring

探索

alternative legislative approaches

替代性立法方法

to PAMA reform.

致PAMA改革。

By relying on a third-party database, the RESULTS Act looks to streamline the data collection process, reducing the administrative burden on clinical laboratories while also ensuring that price data is collected from a broadly representative group of labs.

通过依赖第三方数据库，RESULTS法案旨在简化数据收集流程，减轻临床实验室的行政负担，同时确保从具有广泛代表性的实验室群体中收集价格数据。

'From experience, we understand very clearly that relying on labs to report the data when CMS does not enforce that requirement is going to result in lackluster data,' ACLA President Susan Van Meter told

“从经验中，我们非常清楚地知道，当CMS不强制要求时，依赖实验室报告数据将会导致数据不尽如人意，”ACLA主席苏珊·范·米特表示。

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. 'SALSA would have applied a statistical sampling model but still would have relied on labs to report the data' used by the model.

“SALSA 本会应用一种统计抽样模型，但仍然依赖实验室报告模型所使用的数据。”

'We really want to address two things here,' she said. 'To reduce the reporting burden on labs but also to ensure that you have data that are comprehensive coming into CMS.'

“我们真的想在这里解决两个问题，”她说。“减轻实验室的报告负担，同时也确保你能获得提交给CMS的全面数据。”

The bill sets out criteria for any third-party database to be used for setting payment rates including that it contain at least 50 billion claims from more than 50 private payors and claims administrators, including claims 'with respect to widely available' lab tests; that it 'is a statistically significant repository of claims data that is representative for all 50 states and the District of Columbia;' that its data is validated by quality assurance processes; and that it complies with state and federal privacy and security requirements..

该法案规定了任何第三方数据库用于设定支付费率的标准，包括至少包含来自50多个私人支付方和理赔管理员的500亿条理赔记录，其中包括涉及广泛可用的实验室测试的理赔；该数据库“是一个具有统计学意义的、能够代表全美50个州及哥伦比亚特区的理赔数据存储库”；其数据经过质量保证流程验证；并且符合州和联邦隐私及安全要求。

Van Meter cited Fair Health, a New York-based not-for-profit as one organization that maintains a private payor claims database that could be a suitable source under the RESULTS Act.

范·米特引用了总部位于纽约的非营利组织 Fair Health，该组织维护一个私人支付者索赔数据库，可能成为《RESULTS 法案》下的合适来源。

A third-party database would be used to set rates only for 'widely available' tests, which the bill defines as tests for which more than 100 providers have submitted claims. For tests falling below this threshold, labs will still be required to submit payment data, which will be used to calculate Medicare payment rates.

第三方数据库将仅用于设定“广泛可用”测试的费率，法案将此类测试定义为超过100家供应商已提交索赔的测试。对于低于此门槛的测试，实验室仍需提交支付数据，这些数据将用于计算医疗保险支付费率。

The pricing process for Advanced Diagnostic Laboratory Tests (ADLTs), which .

高级诊断实验室测试（ADLTs）的定价过程，其 。

is separate

是分开的

from the larger PAMA regime, will be unchanged.

来自更大的PAMA机制，将保持不变。

Van Meter said the requirement that labs submit data for non-widely-available tests would ensure that pricing data exists for low-volume tests and proprietary tests, which might not be present in the third-party database.

范·米特表示，要求实验室提交非广泛可用测试的数据，将确保低频测试和专有测试的定价数据存在，而这些数据可能不会出现在第三方数据库中。

'You want to make sure you are giving labs that control to be able to report data,' she said. 'Our membership and [labs] outside of our membership told us they really want that control, particularly on proprietary tests, to report their own data.'

“你希望确保提供给实验室的控制权能够报告数据，”她说。“我们的会员和非会员实验室告诉我们，他们非常希望拥有这种控制权，特别是在专有测试方面，以报告他们自己的数据。”

The RESULTS Act also caps the price cuts a test can see under PAMA at 5 percent a year, down from 15 percent. It does not place a cap on the rise in price a test can see in a year. SALSA had included a 5 percent cap annual price increases along with a 5 percent cap on annual price cuts.

RESULTS法案还将PAMA下测试价格的年度降幅限制在5%，低于之前的15%。该法案并未对测试价格的年度涨幅设置上限。SALSA则包含了5%的年度价格涨幅上限以及5%的年度价格降幅上限。

The bill would also push the next data collection period under PAMA to Jan. 1, 2027 and implementation of new pricing based on that data to the beginning of 2029. Under current law, new Medicare lab pricing will go into effect at the beginning of 2026 calculated on data collected during the first six months of 2019..

该法案还将把PAMA下的下一个数据收集期推迟至2027年1月1日，并基于该数据实施新的定价至2029年初。根据现行法律，新的Medicare实验室定价将于2026年初生效，计算依据为2019年上半年收集的数据。

Some have expressed skepticism that Congress will manage to pass the bill before the end of the year. Speaking at the Next Generation Dx conference in Washington, D.C., last month, Rachel Stauffer, a principal with healthcare consulting firm McDermott+, said that she believes it is unlikely.

一些人对国会是否会在年底前通过该法案表示怀疑。上个月在华盛顿特区举行的下一代诊断会议上，医疗咨询公司McDermott+的负责人雷切尔·斯陶弗表示，她认为这不太可能。

'The calendar is pretty short for congressional action before the end of the year,' she said, noting that Congress still has to deal with appropriations and other issues.

“国会在年底前采取行动的日程相当紧张，”她指出，国会仍然必须处理拨款和其他问题。

In each of the last six years, Congress has passed a one-year delay to PAMA reporting and reimbursement cuts. This is a possibility again this year, though some have suggested it may be a harder lift than in the past.

在过去的六年中，国会每年都通过了一项为期一年的PAMA报告和报销削减延迟。今年再次出现这种可能性，尽管有人认为这可能比以往更难实现。

In past years, the Congressional Budget Office (CBO) has produced preliminary estimates scoring one-year delays as saving money, in some cases as much as $3.26 billion over 10 years. This has made passing one-year delays an attractive option for Congress as the savings could be used to offset other spending.

近年来，国会预算办公室（CBO）已经给出了初步的估算，将一年的延期评分节省资金，在某些情况下，十年内可节省高达32.6亿美元。这使得通过一年的延期成为国会的一个有吸引力的选择，因为节省下来的资金可以用来抵消其他支出。

It is unclear, however, where CBO will land in its scoring of a delay this year..

然而，目前尚不清楚CBO对今年这一延迟的评分将会落在何处。

Perhaps anticipating challenges moving either permanent reform or a temporary delay through Congress, at the end of July several legislators — Reps. Richard Hudson, R-N.C., Brian Fitzpatrick, R-Pa., Neal Dunn, R-Fla., Gus Bilirakis, R-Fla., and John Joyce, R-Pa. —

也许预料到在国会推动永久性改革或暂时延迟都将面临挑战，七月底，几位立法者——理查德·哈德森、布莱恩·菲茨帕特里克、尼尔·邓恩、古斯·比利拉基斯和约翰·乔伊斯——

wrote a letter

写了一封信

to CMS head Mehmet Oz requesting the agency to use its rulemaking authority to delay the upcoming PAMA price cuts and reporting requirements.

向CMS负责人梅赫梅特·奥兹请求该机构运用其规则制定权，推迟即将到来的PAMA价格削减和报告要求。

In the letter, the legislators said that while PAMA 'prohibits a rate reduction that exceeds the applicable percent' calculated under the law, it 'does not require CMS to reduce the payment for a test code by exactly the applicable percent.'

在信中，这些立法者表示，虽然PAMA“禁止降低超过法律规定的适用百分比的费率”，但“并未要求CMS将测试代码的支付减少恰好等于适用的百分比。”

This, they argue, means CMS has the authority to reduce test payment rates by less than the amount calculated under the law, and they ask that CMS use this authority to 'reduce [test payment] rates in 2026 by zero percent' for test codes facing cuts under PAMA.

他们认为，这意味着 CMS 有权将测试支付费率减少的幅度低于法律规定的计算金额，并请求 CMS 行使这一权力，对根据 PAMA 面临削减的测试代码，“在 2026 年将[测试支付]费率减少百分之零”。

The legislators also ask that CMS delay reporting requirements for one year, noting that the agency has in the past used its authority to delay reporting periods. Additionally, they asked that CMS change the upcoming data collection period from Jan. 1, 2019-June 30, 2019, to Jan. 1, 2025-June 30, 2025, as this would provide more complete and up-to-date payor rates and test volumes..

立法者还要求 CMS 将报告要求推迟一年，并指出该机构过去曾使用其权力延迟报告期。此外，他们要求 CMS 将即将来临的数据收集期从 2019 年 1 月 1 日至 2019 年 6 月 30 日更改为 2025 年 1 月 1 日至 2025 年 6 月 30 日，因为这将提供更完整和最新的支付方费率及测试量。

Last month, Robert Hearn, a healthcare attorney with law firm Epstein Becker Green, told

上个月，爱泼斯坦·贝克尔·格林律师事务所的医疗保健律师罗伯特·赫恩告诉

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that CMS, could, if it chooses, take action to forestall PAMA cuts in a matter of days, possibly allowing for a two-track process in which it could give Congress a chance to pass either the RESULTS Act or a temporary delay before moving on its own.

该中心如果愿意，可以在数天内采取行动阻止《患者访问和医保责任法案》的削减措施，可能允许一个双轨进程，即可以给国会机会通过《RESULTS法案》或在自行推进之前进行暂时延迟。

Van Meter said that ACLA, which consulted with legislators on the proposal in the CMS letter, views it as in line with the Trump administration's larger emphasis on deregulation including the president's January executive order requiring that federal agencies reduce regulatory costs.

范·米特表示，ACLA就CMS信函中的提案与立法者进行了磋商，认为其与特朗普政府更大的放松监管方向一致，包括总统一月发布的要求联邦机构降低监管成本的行政命令。

'This seemed to us something that was squarely within the scope of [those] deregulatory efforts,' she said. 'It's a dual track. Let's lean in appropriately on the deregulatory priorities the administration has and then also push for foundational reform via legislation.'

“这对我们来说显然是[那些]放松监管努力范围内的事情，”她说。“这是一条双轨路线。让我们在政府的放松监管优先事项上适当投入精力，同时通过立法推动基础性改革。”

Lab organizations including ACLA and the National Independent Laboratory Association (NILA) released statements on Wednesday in support of the RESULTS Act.

包括ACLA和国家独立实验室协会（NILA）在内的实验室组织周三发表声明支持RESULTS法案。