川普总统关于获得可负担的救命药物的行政命令

川普总统在7月24日签署关于获得可负担的救命药物的行政命令: 胰岛素和可注射的肾上腺素是救命药物。但是,由于价格昂贵,许多患有糖尿病和严重过敏反应的美国人仍然很难获得这些药物。这个政策的目的是使无法通过商业保险或者联邦保险项目(例如Medicare和Medicaid)获得可负担得起的胰岛素和注射肾上腺素的美国人,通过FQHC(联邦合格健康中心),以该中心购买该药品的价格来购买这些药物。这是川普总统未来降低药价所签署的一系列行政命令之一。

Executive Order on Access to Affordable Life-saving Medications

关于获得可负担的救命药物的行政命令

HEALTHCARE   Issued on: July 24, 2020

医疗保健      发布日期: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:

根据美利坚合众国宪法和法律赋予我的总统权力,现命令如下:

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.

第一节. 目的. 胰岛素是一种至关重要的、可以挽救生命的药物。大概有800万美国人依靠胰岛素来管理糖尿病。同样的,可注射的肾上腺素也是一种挽救生命的药物;它可用于抑制严重的过敏反应。

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.

在过去十年内,美国的胰岛素价格急剧上涨。如今,一小瓶胰岛素的标价通常超过250美元,而大多数患者每月至少使用两小瓶。至于可注射的肾上腺素,最近竞争加剧导致价格压低。尽管如此,某些类型的注射肾上腺素价格仍超过600美元/套。虽然糖尿病患者和有严重过敏反应的美国人可通过商业保险或者联邦保险项目(例如Medicare和Medicaid)获得可负担的胰岛素和注射肾上腺素,但是许多美国人在购买这些产品时依旧有很大困难阻力。

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.

根据《美国社会保障法》(Social Security Act)第1905(I)(2)(B)(i)以及(ii)节的定义(经修订的《美国法典》第42卷第1396d(I)(2)(B)(i)和(ii)节),联邦合格健康中心(FQHCs, i.e., Federally Qualified Health Centers)可通过340B处方药项目(340B Prescription Drug Program)获得处方药的折扣价。近年来,许多胰岛素和某些类型的注射型肾上腺素的目录价格急剧上涨。因此,当这些产品分发给联邦合格健康中心时,其中许多产品可能会受到“一分钱定价”政策(“penny pricing” policy)的影响。这就意味着,联邦合格健康中心可能会以每计量单位一分钱的定价购买处方药。但是,美国低收入群体并不一定会在处方药销售点享受到这个大幅折扣。这些低收入美国人通常无法从保险公司、联邦或者州政府商定的折扣中受益,因此,他们可能会遇到高价的胰岛素和注射肾上腺素。

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.

第二节. 政策. 美国的政策目的是,使无法通过商业保险或者联邦保险项目(例如Medicare和Medicaid)获得可负担得起的胰岛素和注射肾上腺素的美国人,通过FQHC(联邦合格健康中心),以该中心购买该药品的价格来购买这些药物。

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:

  • have a high cost sharing requirement for either insulin or injectable epinephrine;
  • have a high unmet deductible; or

(c)  have no health care insurance.

第三节. 改善胰岛素和注射肾上腺素对于未投保人的可用性. 在法律允许的范围内,卫生和公共服务部长(Secretary of Health and Human Services)应采取行动,以确保未来根据《美国公共卫生服务法》(Public Health Service Act)第330(e)节(经修订的《美国法典》第42卷第254b(e)节)的可获得的拨款,以FQHCs(联邦合格健康中心)已建立的惯例为条件,以FQHCs受拨款人或次级受拨款人支付的折扣价提供胰岛素和注射型肾上腺素。此折扣价是根据340B处方药项目规定的折扣价(加上最低管理费),针对于此类低收入群体,并且是由HHS部长确定的,该个人应是:

  • 所要承受的对胰岛素或注射性肾上腺素分摊费用要求很高;

(b) 自付额很高; 或者,

(c) 没有医疗保险。

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.

第四节. 一般条款.

(a) 此命令中的任何内容均不得解释为会损害或以其他方式影响:

  • 法律授予执行部门或机构及其负责人的权力;

(ii) 管理和预算办公室主任拥有的有关预算、行政或立法提案的职能。

(b) 该命令的执行应符合现行法律,并受限于拨款情况而定。

  • 该法令无意于、也不会创造任何权利或利益,无论是实质性的还是程序性的,不能使得任何一方针对美国,其部门、机构或实体,其高级职员、雇员、代理商或任何其他人,从而在法律或衡平法下强制执行。

DONALD J. TRUMP

唐纳德 J. 川普

THE WHITE HOUSE, July 24, 2020.

白宫,2020年7月24日。

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