Recent Analysis
Regulations | Grants | Studies and Reports | Commentary
Regulations
The Organ Procurement and Transplantation Network (OPTN) recently announced that it is offering 11 separate proposals for public comment through March 24, 2020. These include: Addressing medically urgent candidates in new kidney allocation policy (details); Modifications to released kidney and pancreas allocation (details); Distribution of kidneys and pancreata from Alaska (details); HLA equivalency tables update 2020 (details); Enhancements to the... More (Cowey, 1/24/20) #Hospitals, #Delivery Reform
The Centers for Medicare & Medicaid Services (CMS) released a Medicare Learning Network (MLN) article outlining an alternative New Technology Add-On Payment (NTAP) for innovative antibiotics for use in the hospital inpatient setting. CMS is making this change in response to growing antimicrobial resistance (AMR), which poses a particular risk for seniors. To qualify for additional payments under an NTAP,... More (LaRosa) #Physicians, #Public Health
The Food and Drug Administration (FDA) issued final guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The guidance is intended to help sponsors who plan on using minimal residual disease (MRD) as a biomarker in clinical trials conducted under a investigational new drug (IND) application or to... More (Slifer, 1/24/20) #Food and Drug Administration, #Prescription Drugs
Grants
On January 24, 2020, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Violation to the state of California, regarding the state’s universal abortion coverage mandates for health insurance plans and issuers. In August 2014, the California Department of Managed Health Care (DMHC) ordered that all health plan issuers under its jurisdiction... More (Cowey, 1/24/20) #Women’s Health, #Health Equity, #Coverage Decisions
The Health Resources and Services Administration (HRSA) has announced it is seeking the nominations of candidates for appointment to the Advisory Committee on Infant Mortality (ACIM). Established in 1991, the ACIM provides advice to the Health and Human Services (HHS) Secretary on activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants.... More (Cowey, 1/24/20) #Pediatrics, #Women’s Health, #Public Health
The National Institute of Neurological Disorders and Strokes (NINDS) is seeking nominations for non-federal members to serve on the Muscular Dystrophy Coordinating Committee (MDCC). The MDCC is a federal advisory committee that coordinates activities relating to muscular dystrophy across the National Institutes and with other federal health programs. The NINDS is seeking four non-federal, public members and nominations are especially... More (Slifer, 1/24/20) #Chronic Diseases
Studies and Reports
The U.S. Surgeon General issued a new report (full report; summary; press release) on the importance of smoking cessation. The report expands on and updates the findings from a 1990 report on the same topic, and includes: updated findings on nicotine addiction and genetic factors that may impact smoking behaviors; immediate and long-term health and economic benefits of smoking cessation... More (Cowey, 1/24/20) #Prevention, #Public Health
Commentary
CMS Administrator Seema Verma’s responded to SFC Chairman Grassley’s inquiry made last October on GME spending and oversight. In the letter, Administrator Verma highlights the GME reform proposal in the President’s FY 2020 Budget as a solution to address concerns regarding the “fragmented funding streams” and statutory funding limits of GME. The GME reform proposal would consolidate federal GME spending... More (Llamas, 1/24/20) #Graduate Medical Education (GME), #Hospitals, #Physicians
|
