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.
Let ASH Know About Difficulties in Obtaining Guaranteed Coverage for Clinical Trials
Guaranteeing access to clinical trials for cancer patients has long been a priority for ASH. Recently, the Departments of Health and Human Services and Labor (which are both responsible for implementing the various provisions of the health reform law)
there would not be federal regulations to implement the clinical trials coverage provision of the health reform law. The agencies determined the statutory language was self-implementing, and indicated that the Departments do not expect to issue regulations in the near future. Please follow the link above to learn more about this issue.