Featured Analysis

HHS-HHS Finalizes Rule Change to Require HIPAA Covered Entities to Distinguish Partial and Full Refills of Schedule II Drugs for Transaction on the NCPDP Version D.0; Effective in 60 Days

The Department of Health and Human Services (HHS) has published a final rule that will enable covered entities using the Health Insurance Portability and Accountability Act (HIPAA) retail pharmacy transaction to clearly distinguish whether a prescription is a “partial fill” (where less than the full amount prescribed is dispensed) or a full refill. In 2009, HHS adopted the National Council... More (Cowey, 1/24/20) #Pharmacies, #Privacy, #Prescription Drugs, #Public Health, #Opioids

HHS-Department Issues Proposed Rule to Remove Obama-Era Anti-Discrimination Requirements Governing Faith-Based Social Service Agencies and Grantees

The U.S Department of Health and Human Services (HHS) recently announced the release of a proposed rule, titled “Ensuring Equal Treatment of Faith-Based Organizations,” that would remove requirements put in place by the Obama Administration regarding religious organizations that provide human services utilizing government funds. In part, the proposed rule implements President Trump’s Executive Order 13831, issued May 3, 2018, that... More (Cowey, 1/24/20) #Program Integrity, #Social Determinants of Health

Recent Analysis

Regulations | Grants | Studies and Reports | Commentary


HHS-OPTN Accepting Comments on 11 New Organ Allocation Proposals; Due March 24

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

CMS-In MLN Article, Agency Outlines New Add-On Payment for Innovative Antibiotics in Response to Growing Antimicrobial Resistance

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

FDA-Agency Finalizes Guidance on the Use of Minimal Residual Disease for Products to Treat Hematologic Malignancies

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


HHS-Office for Civil Rights Issues Notice of Violation to California for its Abortion Coverage Mandate

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

HRSA-Nominations Sought for Appointment to the Advisory Committee on Infant Mortality (ACIM); Due Feb. 24

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

NIH-Nominations Due Feb. 28 for the Muscular Dystrophy Coordinating Committee

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

HHS-Surgeon General Report on Smoking Cessation Supports Insurance Coverage for Cessation Treatment, Casts Doubt on E-Cigarettes as a Tool to Quit

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


Finance-CMS Administrator Responds to Chairman’s Inquiry on GME Spending and Oversight

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

Upcoming Events

HHS Meeting: Alzheimer’s

Mon January 27, 2020

HHS convenes a meeting of the Advisory Council on Alzheimer's Research, Care, and Services to discuss lessons from epidemiology on understanding current rates of dementia, future trends, and potential preventive... More #Chronic Diseases

Webinar: Social Determinants

Mon January 27, 2020

The National Institute for Health Care Management (NIHCM) Foundation hosts a webinar titled, “Social Determinants of Health: Technology and Workforce Approaches,” featuring Karen DeSalvo (MedPAC), Rivka Friedman (CMMI), among other... More #National Institutes of Health, #Social Determinants of Health

SAMHSA Meeting: Substance Use and Mental Health

Tue January 28, 2020

SAMHSA convenes a meeting of SAMHSA’s National Advisory Council. Details. #Mental and Behavioral Health

Hearing: Medical Leave

Tue January 28, 2020

The House Ways and Means Committee convenes a hearing to discuss legislative proposals for paid family and medical leave. Details. #Pediatrics, #Women’s Health

Hearing: Maternal and Infant Health

Tue January 28, 2020

The House Education and Labor Subcommittee on Health, Employment, Labor, and Pensions and Subcommittee on Workforce Protections convenes a hearing titled, “Expecting More: Addressing America’s Maternal and Infant Health Crisis.”... More #Pediatrics, #Women’s Health

PCORI Meeting: Clinical Research

Tue January 28, 2020

The Patient-Centered Outcomes Research Institute (PCORI) convenes a meeting of the Board of Governors to discuss PCORnet®, The National Patient-Centered Clinical Research Network. Details. #Delivery Reform

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