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The 340B Drug Discount Program is a U.S federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "()tretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services."〔340B Drug Pricing & Pharmacy Affairs http://www.hrsa.gov/opa/〕〔Veterans Health Care Act of 1992, Pub. L. No. 102-585 § 602, 106 Stat. 4943, 4967-4971 (1992).〕〔GAO, Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement, GAO (Washington, D.C.: Sep. 2011) at 1 (referred to as GAO 340B Report ).〕 Maintaining services and lowering medication costs for patients is consistent with the purpose of the program, which is named for the section authorizing it in the Public Health Service Act (PHSA)〔GAO 340B Report p. 1:''"Thirteen of the 29 covered entities we interviewed reported that they generated 340B program revenue that exceeded drug-related costs, which includes the costs of purchasing and dispensing drugs."''〕〔http://www.hrsa.gov/opa/index.html〕〔http://www.hrsa.gov/opa/340Bsurveyrpt.pdf〕 It was enacted by Congress as part of a larger bill signed into law by President George H. W. Bush. ==Program description and history== Congress created the Medicaid Drug Rebate Program in 1990. It required pharmaceutical manufacturers to provide rebates for medication purchases, based on sales to Medicaid beneficiaries, as a condition of having their products covered by Medicaid.〔 The amount of the rebates paid to the states were based on a "best price" calculation that did not take into account the discounted prices that manufacturers were offering directly to Federally funded clinics and public hospitals serving large numbers of low-income and uninsured patients.〔〔H.R. Rep. No 102-384 (II), at 10-11 (1992).〕 Congressional hearings in 1992 found that failing to exempt these voluntary discounts under the Medicaid Drug Rebate Program caused prices to rise "dramatically" for such facilities. According to a detailed study of the most widely used outpatient drugs at five public hospitals, hospital costs for the previously discounted drugs increased, on average, by 32 percent, far in excess of the historical 5 to 9 percent annual increases in drug prices experienced by public hospitals. The steep rise reflected the size of the discounts previously offered, and the dramatic shift once "best prices" were imposed in place of voluntary discounts.〔H.R. Rep. No 102-384 (II), at 10-11 (1992)〕 Consequently, Congress created the 340B program in November 1992 through the enactment of Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act (created under Section 602 of the Veterans Health Care Act of 1992).〔Veterans Health Care Act of 1992, Pub. L. No. 102-585 §602, 106 Stat. 4943, 4967-4971 (1992).〕 The law protected specified clinics and hospitals ("covered entities") from drug price increases and gave them access to price reductions.〔 This law requires pharmaceutical manufacturers participating in the Medicaid program to enter into a second agreement with the Secretary of HHS — called a pharmaceutical pricing agreement (PPA) — under which the manufacturer agrees to provide statutorily specified discounts on "covered outpatient drugs" purchased by government-supported facilities, known as covered entities, that are expected to serve the nation's most vulnerable patient populations.〔42 U.S.C. § 1396r-8(a)(1), (a)(5).〕 These discounts only apply to purchases of covered outpatient drugs.〔U.S. Government Accountability Office, (''Report to Committees: Drug Pricing'' (GAO-11-836) ), September 2011.〕 Covered entities are allowed to dispense the discounted medication both to uninsured patients, and patients covered by Medicare or private insurance. In cases where the covered entity treats an insured patient with discounted medication, the federal government or the patient’s private insurance routinely reimburses the entity for the full price of the medication, and the entity is able to retain the difference between the reduced price it pays for the drug and the full amount for which it is reimbursed.〔Andrew Pollack, Dispute Develops Over Discount Drug Program, N.Y. Times, Feb. 13, 2013.〕 The number of covered entity sites ("parent" sites plus off-site outpatient facilities, also referred to as "child" sites) that take advantage of the 340B program has grown from 8,605 in 2001 to 16,572 in 2011.〔GAO 340B Report, 8〕 From 2005-2011, the number of hospitals participating nearly tripled, from 591 to 1,673, and the number of hospital sites (separate locations of a given hospital that all participate in 340B) almost quadrupled, from 1,233 to 4,426.〔GAO 340B Report, 27-28〕 The program's growth can be attributed in part to three laws that Congress passed over the last decade.〔, 〕〔Deficit Reduction Act of 2005, Pub. L. No. 109-171, § 6004, 120 Stat. 4, 61 (2006) (amending 42 U.S.C. § 1296r-8(a)(5)(B)).〕〔Patient Protection and Affordable Care Act, Pub. L. 111-148, §§ 7101-3, 124 Stat. 119, 128 (2010).〕 Growth in the number of covered entity sites also stems from a recent federal policy change. In 2012, the Health Resources and Services Administration (HRSA) began requiring hospitals to register all offsite facilities using 340B drugs. Previously, hospitals had to register only those sites at separate addresses that received direct shipments of 340B drugs. Additionally, all clinics located off-site of the parent hospital, regardless of whether those clinics are in the same building, must register with HRSA as outpatient facilities of the parent 340B-eligible hospital if the covered entity purchases and/or provides 340B drugs to patients of those facilities.〔http://www.hrsa.gov/opa/faqs/index.html〕 Approximately one-third of all U.S. hospitals participate in the 340B program.〔GAO 340B Report, 20〕 Pharmaceuticals purchased at 340B pricing now account for 2 percent of all medicines purchased in the United States each year.〔U.S. Department of Health and Human Services, Health Resources and Services Administration, (''Fiscal Year 2014 Justifications for Estimates for Appropriation Committees ).〕 As of 2011 covered entities’ spending on 340B drug purchases was estimated to be about $6 billion annually.〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「340B Drug Pricing Program」の詳細全文を読む スポンサード リンク
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