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The federal 340B Drug Pricing Program provides access to reduced-price drugs for eligible health care providers registered with the U.S. Department of Health and Human Services as “covered entities.” These covered entities include facilities that serve vulnerable communities.Under the program, 340B covered entities may purchase select outpatient and over-the-counter drugs at discounted prices. These prices are at least as low as the price state Medicaid agencies pay for the same drugs and are often lower. To receive 340B discounted drugs, an individual must be a patient of a 340B entity. In recent years, the number of 340B covered entities has increased dramatically.
The 340B Drug Pricing Program (340B Program) and the Medicaid Drug Rebate Program require manufacturers to provide discounts on outpatient drugs in order to have their drugs covered by Medicaid. These discounts take the form of reduced sales prices for covered entities participating in the 340B Program--eligible hospitals and federal grantees--and rebates on drugs dispensed to Medicaid beneficiaries, shared by states and the federal government. This book looks at important issues pertaining to the 340B Drug Pricing Program.
The Health Resources and Services Admin. (HRSA) oversees the 340B Drug Pricing Program, through which participating drug manufacturers give certain entities within the health care safety net -- known as covered entities (CE) -- access to discounted prices on outpatient drugs. CE include specified fed. grantees and hospitals. The number of CE sites has nearly doubled in the past 10 years to over 16,500. This study examines: (1) the extent to which CE generate 340B revenue, factors that affect revenue generation, and how they use the program; (2) how manufacturers' dist. of drugs at 340B prices affects CE or non-340B providers' access to drugs; and (3) HRSA's oversight of the 340B program. Charts and tables. A print on demand report.
"Health Resources and ServicesAdministration (HRSA), within in theDepartment of Health and HumanServices (HHS), oversees the 340BDrug Pricing Program, through whichparticipating drug manufacturers givecertain entities within the health caresafety net-known as coveredentities-access to discounted priceson outpatient drugs. Covered entitiesinclude specified federal grantees andhospitals. The number of coveredentity sites has nearly doubled in thepast 10 years to over 16,500.The Patient Protection and AffordableCare Act (PPACA) mandated that GAOaddress questions related to the 340Bprogram. GAO examined: (1) theextent to which covered entitiesgenerate 340B revenue, factors thataffect revenue generation, and howthey use the program; (2) howmanufacturers' distribution of drugs at340B prices affects covered entities' ornon-340B providers' access to drugs;and (3) HRSA's oversight of the 340Bprogram. GAO reviewed key laws andguidance, analyzed relevant data, andconducted interviews with 61 340Bprogram stakeholders selected torepresent a range of perspectives,including HRSA, 29 covered entities,10 manufacturers and representatives,and 21 others. Selection ofstakeholders was judgmental and thus,responses are not generalizable. "
Chapter 1 examines the actions of drug companies in raising prescription drug prices in the United States, as well as the effects of these actions on the Federal and state budgets, and on American families. Chapter 2 addresses frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The 340B Drug Pricing Program requires drug manufacturers to sell outpatient drugs at discounted prices to covered entitiesâeligible clinics, hospitals, and othersâin order to have their drugs covered by Medicaid. Covered entities are only allowed to provide 340B drugs to certain eligible patients. Chapter 3 reviews the Health Resources and Services Administration's (HRSA) oversight of the 340B Program to ensure compliance with program rules. In 2017, nearly 60% of U.S. adults aged 18â64 reported being prescribed medication in the past 12 months. Approximately 70% of prescription medications carry out-of-pocket costs. Strategies to reduce prescription drug costs at the individual level are discussed in chapters 4 and 5. Each year, Americans pay more for prescription drugs, and rising drug prices have a disproportionate impact on older Americans. Chapter 6 examines the history of rising drug prices for the brand-name drugs most commonly prescribed for seniors. Generic drugsâcopies of brand-name drugsâlead to significant cost savings. Before a generic drug can be marketed, FDA must approve the generic drug application. According to FDA, applications go through an average of three cycles of review before being approved, which may take years. Chapter 7 examines 1) the first review cycle approval rate of generic drug applications in recent years and factors that may have contributed to whether applications were approved; and 2) changes FDA has made to increase the first review cycle approval rate.
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
The creation of the commission was to study obtaining greater efficiencies and cost savings in public pharmaceutical costs through increased participation in the federal 340B Drug Pricing Program with particular emphasis on Medicaid and inmate populations.