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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.
Untangle New Requirements and Strengthen Your 340B Drug Program The 340B Program Handbook: Integrating 340B into the Health-System Pharmacy Supply Chain The 340B Drug Program Handbook is the comprehensive guide for pharmacy leaders, hospital administrators, legal counsel, and pharmacy managers. Developed by Andrew L. Wilson, PharmD, FASHP, this practical, clear-cut reference provides the most up-to-date information needed to implement and keep a high-performing program running well, including: · Complying with 340B requirements · Maintaining technical supply chain efficiency · Meeting effectiveness goals · Achieving heath-system financial objectives
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.
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.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) The Law Library presents the complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition). Updated as of May 29, 2018 The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). This book contains: - The complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) - A table of contents with the page number of each section
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition) The Law Library presents the complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition). Updated as of May 29, 2018 The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). This book contains: - The complete text of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (US Health Resources and Services Administration Regulation) (HRSA) (2018 Edition) - A table of contents with the page number of each section
In 1992, Congress created the 340B Drug Pricing Program that requires drug manufacturers to provide outpatient drugs to participating hospitals with substantial discounts. Although the intent of the program is to allow covered entities to increase access to care for more vulnerable patients, hospitals are not required by law to pass on the discounts. Therefore, a concern is that hospitals might over-prescribe. This dissertation includes three chapters to study the effects of the 340B program on hospitals’ behavior changes: Chapter 1 uses state aggregate hospital service spending data from the Centers for Medicare and Medicaid Services (CMS) to study the nation-wide impact of state 340B hospital participation on state hospital service spending. Controlling for state fixed effects, time fixed effects and state specific time trends, I find, on average, a 1 percentage point increase in state 340B hospital share leads to a 12.8% increase in state hospital service spending per capita. With only hospital spending data, analysis in this chapter cannot distinguish between a scenario where hospitals increase their spending to improve quality of care, consistent with the intent of the 340B program, and a scenario where hospitals are simply increasing spending without improving quality to maximize profit. Chapter 2 complements the analysis in Chapter 1 by exploring the causal impact of the 340B program on hospitals' medication cost, patient mix and quality of care. Working with 15 million ambulatory visits to Florida hospitals from 2005 to 2015, I use a series of difference-in-difference (DID) and synthetic control methods (SCM) based on the 2010 340B eligibility expansion, I find an average increase of $111.35 in medication cost per visit due to the 2010 expansion. Quantile regressions reveal that hospitals with the highest proportion of charity care and uninsured patients keep medication cost low and on the most expensive visits, they significantly reduce medication cost for patients. The remaining newly eligible hospitals significantly raise medication cost after the expansion. The increase becomes larger the more expensive the treatment is. Finally, I find some indications that newly eligible hospitals increased Medicaid patient mix and improved quality of care, but the evidence is not strong enough to be conclusive. Chapter 3 further extends the analysis by examining the impact of market power on 340B hospitals' behavior changes. Using the CMS nation-wide state aggregate data, I find the positive relationship between the state's 340B hospital share and state aggregate hospital service spending is stronger when hospitals' market share is higher. Working with the Florida data, using a series difference-in-difference-indifference (DDD) regressions, complemented by DID and SCM estimations, I find the 340B hospitals with low market shares seem to fulfill the mission of the program by keeping medication cost low, treating more low-income patients covered by Medicaid and Medicaid managed care and provide more charity to the communities. Compared to them, hospitals with high market shares significantly raise additional medication cost, treat fewer low-income patients but substantially more commercially insured patients. There are some signs of post-expansion quality improvement among all the newly eligible hospitals, measured by the post-operative adverse reaction rates, but heterogeneity exists in hospitals' length of stay and nonroutine discharge rates. Hospitals with high market shares seem to treat more patients in their own outpatient facilities with a shorter length of stay. While the ones with low market shares experience increased length of stay, possibly due to worse health conditions among the additional Medicaid and Medicaid managed care patients they treat. As a summary, this dissertation finds the average 340B hospital raise their medication cost upon participation in the program, but heterogeneity exists that some of them seem to fulfill the mission of the program. There are signs of quality improvement in the data, but future research could adopt more quality measures to study the cost-effectiveness on the price increase, as well as the welfare influence on the cost reduction.
Drug Discount Program: Status of GAO Recommendations to Improve 340B Drug Pricing Program Oversight