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UPDATE: May 21, 2021: On Thursday, drugmaker Eli Lilly filed a motion in an Indiana district court to halt 340B-related monetary penalties, three days after the Biden administration set a June 1 deadline for pharmaceutical companies to comply with new conditions in the drug discount program and allow hospital pharmacies access to discounted drugs.
The suit alleges a Monday letter from Diana Espinosa, acting head of the Health Resources and Services Administration, gives no legal explanation or justification for the arbitrary June 1 deadline.
Lilly filed an almost identical lawsuit in January 2020. The Indianapolis-based pharma said it expected the government to follow the briefing schedule outlined in that suit before mandating compliance with 340B and forcing it to pay substantial and irretrievable sums of money.
HHS to expand telehealth mental health services for kids
HHS to expand telehealth mental health services for kids
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HHS will spend more than $14 million to expand telehealth-based mental health services for children and adolescents, the agency said Thursday.
The additional funding will grow the Pediatric Mental Health Care Access program, which aims to integrate behavioral health services into pediatric primary care via telehealth, to new states and regions. About 22% of children have a behavioral health-related condition, but just 20% of them receive care from a specialized provider. Now more than ever, families need mental and behavioral healthcare for their children, but significant disparities in access to this treatment continue to exist. The expansion of the Pediatric Mental Health Care Access Program paves the way for more children to receive necessary mental health services, especially those in underserved communities, Health Resources and Services Administration
Dive Brief:
The U.S. Department of Health and Human Services has called out six pharmaceutical companies for violating rules under the 340B drug discount program, ordering them to repay affected healthcare providers for previous overcharges and warning of more penalties if they don t comply.
Last July, some drugmakers stopped giving the 340B ceiling price the maximum they can charge on products sold to covered entities and dispensed through contract pharmacies. Others limited sales by requiring specific data or selling products only after a covered provider demonstrated 340B compliance, according to the Health Resources and Services Administration, which administers the program.
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On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies.
Background
As regular readers of our blog know, for a number of years the 340B Program has been at a crossroads. The 340B Program, overseen by the Health Resources and Services Administration (HRSA), was intended to provide a safety net pipeline for individuals in need of access to out-patient drugs. However, the 340B Program grew by leaps and bounds over the last fifteen years and, for many larger hospital systems, it transformed into a major source of revenue s