New Proposed Guidance on the 340B Drug Discount Program
On August 28, the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B program, issued
that is intended to clarify and in some cases establish rules for participating in the program. The proposed guidance demonstrate some of the administrative difficulty of the program for both participants and the government monitors.
NIH Identifies Priorities for Pediatric Therapeutics
In compliance with the Best Pharmaceuticals for Children Act (BPCA), NIH published a list of therapeutics identified by the agency as the highest priority for study in pediatric populations. The BPCA requires sponsors of drugs for adult indications to study pediatric indications if a disease occurs in children. NIH must update its priority list every three years.
NHLBI Releases Draft Strategic Research Priorities for Review and Comments
The National Heart, Lung and Blood Institute (NHLBI) released its draft strategic research priorities and is requesting additional input from the scientific community by August 28, 2015. The strategic planning process aims to identify compelling questions and critical challenges that should be addressed within the next decade. ASH submitted several research recommendations based on the ASH Agenda for Hematology Research and ASH Sickle Cell Priorities and is pleased to see many of them incorporated into the NHLBI's draft strategic research priorities. All ASH members are encouraged to review and comment by the deadline. Please see link above for more details.
Medicare Releases Proposed Payment Rates and Associated Policies for Physicians in 2016
On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) released its
governing payments for physician services and other associated policies covering the calendar year of 2016. This is the first physician fee schedule proposed rule following
the passage of the Medicare Access and CHIP Reauthorization Act (MACRA), which eliminated the sustainable growth rate formula that had long mandated cuts each year. Please follow the link above to learn more.