川普总统通过废除中间商佣金以降低病人药物价格的行政令

川普总统于7月24日宣布了取消中间商在药物买卖当中的佣金及提成,以降低病人的药物价格,并为病人缩减长期的自付药物的支出。此行政令将药物的回扣转而让利予病人,而非中间商,使病人在购买药物时得以节省大量的金钱。

通过废除中间商佣金以降低病人药物价格的行政令

Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen

发布于2020年7月24日

Issued on: July 24, 2020

行政令

Executive Orders

根据《美利坚合众国宪法》和美利坚合众国法律赋予我之总统权力,兹命令如下:

By the authority vested in me as President by the Constitution and the laws of the USA, it is hereby ordered as follows:

第一则:目的

Section 1.  Purpose.  

众多关系复杂的买家和协调商在购买药品过程中经常将客户与制造商区隔开,是导致美国药物价格高昂的其中一个原因

One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process.

其结果就是病人在销售点所看到的价格并未实际反映其所透过的保险公司和保险公司所雇用的中间人两者所实际支付的价格。

The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs.

反之,这些中间商(即健康计划赞助商和药房福利经理(PBM))经协商后,得以在价格上取得大幅的折扣,有的折扣甚至高达药物价格的百分之五十。

Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.

医疗保险病人一般以药物的标价为准而须分担药物的成本,于是病人因此须支付高于他们所原应支付的价格,而中间商则因此可获取大笔的“回扣”支票。

Medicare patients, whose cost sharing is typically based on list prices, pay more than they should for drugs while the middlemen collect large “rebate” checks.

这些回扣的功能等同于佣金,并剥夺侵蚀了原可用于使用药物的医保病人身上的资源。

These rebates are the functional equivalent of kickbacks, and erode savings that could otherwise go to the Medicare patients taking those drugs.

但是目前,联邦法规为此类折扣创造了一个安全港,并在法律上禁止将其视为佣金。

Yet currently, Federal regulations create a safe harbor for such discounts and preclude treating them as kickbacks under the law.

解决该问题即可让医保病人省下数十亿美元。

Fixing this problem could save Medicare patients billions of dollars. 

卫生与公共服务部之总监察长办公室发现,处于灾难性的阶段的医疗保险计划D 部分的病人须自付高价药物的费用由2010至2015年之间增加了47%,由每月$175美金涨至每月$257美金。

The Office of the Inspector General at the Department of Health and Human Services has found that patients in the catastrophic phase of the Medicare Part D program saw their out-of-pocket costs for high-price drugs increase by 47 percent from 2010 to 2015, from $175 per month to $257 per month.

通过反回扣法令则可缩小提供这些折扣的额度,以让医保计划D部分处方药数百亿美元的回扣可直接用于病患,并可让病患每年在药房处节省数百或数千美元。

Narrowing the safe harbor for these discounts under the anti-kickback statute will allow tens of billions in dollars of rebates on prescription drugs in the Medicare Part D program to go directly to patients, saving many patients hundreds or thousands of dollars per year at the pharmacy counter.

第二节:政策

Sec. 2.  Policy.  

根据美国的政策,处方药的折扣应让利于病人。

It is the policy of the United States that discounts offered on prescription drugs should be passed on to patients.

第三节:将药物的回扣回馈予病人,而非中间商

Sec. 3.  Directing Drug Rebates to Patients Instead of Middlemen.  

卫生与公共服务部部长应完成立法程序,以便:

The Secretary of Health and Human Services shall complete the rulemaking process he commenced seeking to:

(a) 根据1128B(b)社会安全法,42 U.S.C. 1320a-7b中的反回扣法令,任何未适用的销售点以追溯形式的价格折扣,以及药物制造商提供执行医疗保险计划D 部分的健康计划赞助商、药房或药房福利经理们 (PBM) 其他形式的报酬,都将从安全港保护中剔除。

(a)  exclude from safe harbor protections under the anti-kickback statute, section 1128B(b) of the Social Security Act, 42 U.S.C. 1320a–7b, certain retrospective reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and

(b) 建立新的安全港,以允许健康计划赞助商、药房以及药房福利经理们给予病人的销售点提供折扣,以减少病人的支出,并因此允许收取某种具善意的药物福利经理 (PBM) 服务费。

(b)  establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient’s point-of-sale in order to lower the patient’s out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.

第四节:维持低保费

Sec. 4.  Protecting Low Premiums.  

在实施此命令的第三节前,卫生于公共服务部部长应确保并公布所采取的行动并不会增加联邦的支出、医保受益人所需付的保费以及病人自付的总额。

Prior to taking action under section 3 of this order, the Secretary of Health and Human Services shall confirm — and make public such confirmation — that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.

第五节:一般条文

Sec. 5.  General Provisions. 

(a) 此命令中的任何内容均不应意为损害,或以其他方式影响:

(a) Nothing in this order shall be construed to impair or otherwise affect:

(i)法律授权的执行部门、机构或其负责人的权力; 亦或

(i)the authority granted by law to an executive department or agency, or the head thereof; or

(ii)行政管理和预算局局长及其预算、行政,或立法提案有关的职能。

(ii)the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) 此命令应按照适用的法律并在有拨款的情况下执行。

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) 此命令并非意图、亦不会赋予任何一方任何权力或利益,透过实质性或程序性的强制执行现行法或衡平法,以对抗美国或其任何部门、机构或实体、其官员、员工或任何中介或任何个人。

(c)  This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

DONALD J. TRUMP

唐纳德 J.川普

THE WHITE HOUSE,

白宫

July 24, 2020.

2020年7月24日

白宫原文连结: https://www.whitehouse.gov/presidential-actions/executive-order-lowering-prices-patients-eliminating-kickbacks-middlemen/

翻译:【Alien】校对:【BIM 编辑:【GM31】

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joop12345
6 月 之前

谢谢

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