川普總統關於獲得可負擔的救命藥物的行政命令

川普總統在7月24日簽署關於獲得可負擔的救命藥物的行政命令: 胰島素和可注射的腎上腺素是救命藥物。但是,由於價格昂貴,許多患有糖尿病和嚴重過敏反應的美國人仍然很難獲得這些藥物。這個政策的目的是使無法通過商業保險或者聯邦保險項目(例如Medicare和Medicaid)獲得可負擔得起的胰島素和注射腎上腺素的美國人,通過FQHC(聯邦合格健康中心),以該中心購買該藥品的價格來購買這些藥物。這是川普總統未來降低藥價所簽署的一系列行政命令之一。

Executive Order on Access to Affordable Life-saving Medications

關於獲得可負擔的救命藥物的行政命令

HEALTHCARE   Issued on: July 24, 2020

醫療保健      發布日期:2020年七月24日 

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

根據美利堅合眾國憲法和法律賦予我的總統權力,現命令如下:

Section 1.  Purpose.  Insulin is a critical and life-saving medication that approximately 8 million Americans rely on to manage diabetes.  Likewise, injectable epinephrine is a life‑saving medication used to stop severe allergic reactions.

第一節. 目的. 胰島素是一種至關重要的、可以挽救生命的藥物。大概有800萬美國人依靠胰島素來管理糖尿病。同樣的,可注射的腎上腺素也是一種挽救生命的藥物;它可用於抑制嚴重的過敏反應。

The price of insulin in the United States has risen dramatically over the past decade.  The list price for a single vial of insulin today is often more than $250 and most patients use at least two vials per month.  As for injectable epinephrine, recent increased competition is helping to drive prices down.  Nevertheless, the price for some types of injectable epinephrine remains more than $600 per kit.  While Americans with diabetes and severe allergic reactions may have access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs such as Medicare and Medicaid, many Americans still struggle to purchase these products.

在過去十年內,美國的胰島素價格急劇上漲。如今,一小瓶胰島素的標價通常超過250美元,而大多數患者每月至少使用兩小瓶。至於可注射的腎上腺素,最近競爭加劇導致價格壓低。儘管如此,某些類型的注射腎上腺素價格仍超過600美元/套。雖然糖尿病患者和有嚴重過敏反應的美國人可通過商業保險或者聯邦保險項目(例如Medicare和Medicaid)獲得可負擔的胰島素和注射腎上腺素,但是許多美國人在購買這些產品時依舊有很大困難阻力。

Federally Qualified Health Centers (FQHCs), as defined in section 1905(l)(2)(B)(i) and (ii) of the Social Security Act, as amended, 42 U.S.C. 1396d(l)(2)(B)(i) and (ii), receive discounted prices through the 340B Prescription Drug Program on prescription drugs.  Due to the sharp increases in list prices for many insulins and some types of injectable epinephrine in recent years, many of these products may be subject to the “penny pricing” policy when distributed to FQHCs, meaning FQHCs may purchase the drug at a price of one penny per unit of measure.  These steep discounts, however, are not always passed through to low-income Americans at the point of sale.  Those with low-incomes can be exposed to high insulin and injectable epinephrine prices, as they often do not benefit from discounts negotiated by insurers or the Federal or State governments.

根據《美國社會保障法》(Social Security Act)第1905(I)(2)(B)(i)以及(ii)節的定義(經修訂的《美國法典》第42卷第1396d(I)( 2)(B)(i)和(ii)節),聯邦合格健康中心(FQHCs, ie, Federally Qualified Health Centers)可通過340B處方藥項目(340B Prescription Drug Program)獲得處方藥的折扣價。近年來,許多胰島素和某些類型的注射型腎上腺素的目錄價格急劇上漲。因此,當這些產品分發給聯邦合格健康中心時,其中許多產品可能會受到“一分錢定價”政策(“penny pricing” policy)的影響。這就意味著,聯邦合格健康中心可能會以每計量單位一分錢的定價購買處方藥。但是,美國低收入群體並不一定會在處方藥銷售點享受到這個大幅折扣。這些低收入美國人通常無法從保險公司、聯邦或者州政府商定的折扣中受益,因此,他們可能會遇到高價的胰島素和注射腎上腺素。

Sec. 2.  Policy.  It is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from an FQHC at a price that aligns with the cost at which the FQHC acquired the medication.

第二節. 政策. 美國的政策目的是,使無法通過商業保險或者聯邦保險項目(例如Medicare和Medicaid)獲得可負擔得起的胰島素和注射腎上腺素的美國人,通過FQHC(聯邦合格健康中心),以該中心購買該藥品的價格來購買這些藥物。

Sec. 3.  Improving the Availability of Insulin and Injectable Epinephrine for the Uninsured.  To the extent permitted by law, the Secretary of Health and Human Services shall take action to ensure future grants available under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254b(e), are conditioned upon FQHCs’ having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:

(a) have a high cost sharing requirement for either insulin or injectable epinephrine;

(b) have a high unmet deductible; or

(c) have no health care insurance.

第三節. 改善胰島素和注射腎上腺素對於未投保人的可用性. 在法律允許的範圍內,衛生和公共服務部長(Secretary of Health and Human Services)應採取行動,以確保未來根據《美國公共衛生服務法》(Public Health Service Act)第330(e)節(經修訂的《美國法典》第42卷第254b(e)節)的可獲得的撥款,以FQHCs(聯邦合格健康中心)已建立的慣例為條件,以FQHCs受撥款人或次級受撥款人支付的折扣價提供胰島素和注射型腎上腺素。此折扣價是根據340B處方藥項目規定的折扣價(加上最低管理費),針對於此類低收入群體,並且是由HHS部長確定的,該個人應是:

  • 所要承受的對胰島素或註射性腎上腺素分攤費用要求很高;
  • 自付額很高; 或者,
  • 没有醫療保險。

Sec. 4.  General Provisions.  (a) Nothing in this order shall be construed to impair or otherwise affect:

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

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

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

(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.

第四節. 一般條款.

(a) 此命令中的任何內容均不得解釋為會損害或以其他方式影響:

  • 法律授予執行部門或機構及其負責人的權力;

(ii) 管理和預算辦公室主任擁有的有關預算、行政或立法提案的職能。

(b) 該命令的執行應符合現行法律,並受限於撥款情況而定。

(c) 該法令無意於、也不會創造任何權利或利益,無論是實質性的還是程序性的,不能使得任何一方針對美國,其部門、機構或實體,其高級職員、僱員、代理商或任何其他人,從而在法律或衡平法下強制執行。

DONALD J. TRUMP

唐納德 J. 川普

THE WHITE HOUSE, July 24, 2020.

白宮,2020年7月24日。

閱讀白宮網站原文

翻譯:【Cyndi】 校對:【RD16】編輯:【GM80】

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