…contract pharmacies neither purchase 340B drugs, nor receive the 340B price. They merely dispense 340B drug to the patients of covered entities, while covered entities purchase and maintain title to…

…such products. 340B Ceiling Price—New 340B Drugs When new drugs enter the market, there are insufficient data available to calculate the AMP, and thereby, the 340B ceiling price. Therefore, HRSA…

…are admitted to the 340B Program and listed on the 340B Drug Pricing Program Database.  However, a children’s hospital will be eligible for retroactive discounts only to the extent that…

…reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. The 340B program, authorized under Section 340B of the Public Health Services Act and administered…

Beginning February 15, drug manufacturers will have a new price to report to the Federal government: 340B ceiling price. Under Section 340B of the Public Health Service Act, a manufacturer…

…proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the…

…found that the conditions set by Novartis and United Therapeutics on covered entities did not violate the 340B statute, although more restrictive conditions could violate the law. The 340B statute…

…340B Drug Discount Program since the Program was established in 1992.  This Program, authorized under section 340B of the Public Health Service Act, requires manufacturers who execute a Pharmaceutical Pricing…

…outpatient payment rates for 340B drugs at Average Sales Price (ASP) minus 22.5%. A brief history: Section 340B of the Public Health Service Act requires a manufacturer of covered outpatient…

…announced that it would initiate a survey of 340B drug acquisition costs for 340B hospitals for certain quarters of 2018 and 2019, which might then provide a basis under option…

…the U.S., are diverting drugs purchased at low 340B prices to non-340B patients, the companies are declining to sell drugs to 340B covered entities that use multiple contract pharmacies. When…

…Covered Entities profited too much from reimbursement for 340B discounted drugs, CMS reduced the payment amount for hospital outpatient separately payable 340B drugs to ASP minus 22.5%. The American Hospital…

…drugs when purchased by certain of these covered entities (the so-called “orphan drug exclusion”).  For readers not familiar with the 340B Program, section 340B of the Public Health Services Act…

…in violation of the 340B statute and their 340B agreements with HHS.  The letters request the manufacturer to submit to HRSA within 30 days a plan for providing refunds to…

…a number of key areas:  A.        340B Program eligibility and registration B.        Drugs eligible for purchase under the 340B program C.        Individuals eligible to receive 340B drugs D.        Covered Entity…