川普總統簽署有關取消中間商傭金以降低藥物價格的行政命令

川普總統於7月24日宣佈了取消中間商在藥物買賣當中的傭金及提成,以降低病人的藥物價格,並為病人縮減長期的自付藥物的支出。此行政命令將藥物的回扣轉而讓利予病人,而非中間商,使病人在購買藥物時得以節省大量的金錢。

通過廢除中間商傭金以降低病人藥物價格的行政命令

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

發佈於2020年7月24日

Issued on: July 24, 2020

行政命令

Executive Orders

根據《美利堅合眾國憲法》和美利堅合眾國法律賦予我之總統權力,茲命令如下:

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

第一則:目的

Section 1.  Purpose.  

眾多關係複雜的買家和協調商在購買藥品過程中經常將客戶與製造商區隔開,是導致美國藥物價格高昂的其中一個原因

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.

其結果就是病人在銷售點所看到的價格並未實際反映其所透過的保險公司和保險公司所僱用的中間人兩者所實際支付的價格。

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,這些中間商(即健康計劃贊助商和藥房福利經理(PBM))經協商後,得以在價格上取得大幅的折扣,有的折扣甚至高達藥物價格的百分之五十。

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.

醫療保險病人一般以藥物的標價為准而須分擔藥物的成本,於是病人因此須支付高於他們所原應支付的價格,而中間商則因此可獲取大筆的“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.

這些回扣的功能等同於傭金,並剝奪侵蝕了原可用於使用藥物的醫保病人身上的資源。

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,聯邦法規為此類折扣創造了一個安全港,並在法律上禁止將其視為傭金。

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

解決該問題即可讓醫保病人省下數十億美元。

Fixing this problem could save Medicare patients billions of dollars. 

衛生與公共服務部之總監察長辦公室發現,處於災難性的階段的醫療保險計畫D 部分的病人須自付高價藥物的費用由2010至2015年之間增加了47%,由每月$175美金漲至每月$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.

通過反回扣法令則可縮小提供這些折扣的額度,以讓醫保計劃D部分處方藥數百億美元的回扣可直接用於病患,並可讓病患每年在藥房處節省數百或數千美元。

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.

第二節:政策

Sec. 2.  Policy.  

根據美國的政策,處方藥的折扣應讓利於病人。

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

第三節:將藥物的回扣回饋予病人,而非中間商

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

衛生與公共服務部部長應完成立法程式,以便:

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

(a) 根據1128B(b)社會安全法,42 U.S.C. 1320a-7b中的反回扣法令,任何未适用的銷售點以追溯形式的价格折扣,以及藥物製造商提供執行醫療保險計畫D 部分的健康計劃贊助商、藥房或藥房福利經理們 (PBM) 其他形式的報酬,都將從安全港保護中剔除。

(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,以允許健康計畫贊助商、藥房以及藥房福利經理們給予病人的銷售點提供折扣,以減少病人的支出,並因此允許收取某種具善意的藥物福利經理 (PBM) 服務費。

(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.

第四節:維持低保費

Sec. 4.  Protecting Low Premiums.  

在實施此命令的第三節前,衛生於公共服務部部長應確保並公布所採取的行動並不會增加聯邦的支出、醫保受益人所需付的保費以及病人自付的總額。

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.

第五節:一般條文

Sec. 5.  General Provisions. 

(a) 此命令中的任何內容均不應意為損害,或以其他方式影響:

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

(i)法律授權的執行部門、機構或其負責人的權力; 亦或

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

(ii)行政管理和預算局局長及其預算、行政,或立法提案有關的職能。

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

(b) 此命令應按照適用的法律並在有撥款的情況下執行。

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

(c) 此命令並非意圖、亦不会赋予任何一方任何權力或利益,透过實質性或程序性的强制执行現行法或衡平法,以對抗美國或其任何部門、機構或實體、其官員、員工或任何仲介或任何個人。

(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.

唐納德 J.川普

DONALD J. TRUMP

白宮

THE WHITE HOUSE,

2020年7月24日

July 24, 2020.

白宫原文链接:https://www.whitehouse.gov/presidential-actions/executive-order-increasing-drug-importation-lower-prices-american-patients/

翻譯:【Alien】校對:【BIM 編輯:【GM31】

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