Proposed Rule Issued for Investigational New Drug Application Annual Reporting; Comments Due March 9

Proposed Rule Issued for Investigational New Drug Application Annual Reporting; Comments Due March 9

The Food and Drug Administration (FDA) issued a proposed rule to establish a new annual reporting requirement for investigational new drug applications (INDs), known as the FDA development safety update report (DSUR).  Additional details of the proposed rule follow: The FDA asserts that the proposed FDA DSUR would require these sponsors to provide an annual report that is more comprehensive… (Slifer, December 8, 2022) #Food and Drug Administration, #Prescription Drugs

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FNS Announces $60 Million in Round Two TEFAP Reach and Resiliency Grants

FNS Announces $60 Million in Round Two TEFAP Reach and Resiliency Grants

The Department of Agriculture (USDA) Food and Nutrition Service (FNS) announced $60.58 million in funding for round two Reach and Resiliency grants in The Emergency Food Assistance Program (TEFAP). The funding will be used by state TEFAP agencies to better serve individuals in remote, rural, tribal, and other low-income areas through creative and unique solutions like mobile food pantries and… (McClurg, December 7, 2022) #Health Equity, #Nutrition

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Agency Proposes Rule to Enhance Interoperability and Streamline Prior Authorization; Includes New Data Exchange Requirements and 5 RFIs

Agency Proposes Rule to Enhance Interoperability and Streamline Prior Authorization; Includes New Data Exchange Requirements and 5 RFIs

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule to improve the electronic exchange of health care data and streamline prior authorization (press release; fact sheet).  The regulations apply to Medicare Advantage (MA) organizations, Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally… (McClurg, December 6, 2022) #Health Information Technology

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Agency Issues the March 2022-September 2022 Semiannual Report to Congress

Agency Issues the March 2022-September 2022 Semiannual Report to Congress

The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released the Semiannual Report to Congress providing an overview of the Agency’s activities from March 2022 through September 2022. The report includes data on OIG’s reports, audits, investigations, and other statistics. The report describes OIG’s work on identifying significant problems, abuses, deficiencies, remedies, and investigative outcomes… (Colocho, December 6, 2022) #Costs, #COVID-19, #Drug Pricing, #Hospitals, #Opioids, #Public Health

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Agency Announces A New Center of Excellence to Study Nutrition and Chronic Diseases

Agency Announces A New Center of Excellence to Study Nutrition and Chronic Diseases

The Department of Agriculture (USDA) announced a new virtual Agricultural Science Center of Excellence for Nutrition and Diet for Better Health (ASCEND for Better Health) that will accelerate research on diet-related chronic diseases. The new center will connect existing resources, people, and programs to increase coordination and cooperation in research. USDA will also focus on better understanding the needs of… (McClurg, December 5, 2022) #Chronic Diseases, #Health Equity, #Nutrition

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HHS Extends Enforcement Discretion for Good Faith Estimates; NPRM Scheduled for Jan. 2023 Likely to Propose New Applicability Date

HHS Extends Enforcement Discretion for Good Faith Estimates; NPRM Scheduled for Jan. 2023 Likely to Propose New Applicability Date

The Department of Health and Human Services (HHS) extended enforcement discretion, pending future rulemaking, for the requirement that convening providers and facilities provide good faith estimates (GFEs) for uninsured (or self-pay) individuals of expected charges from co-providers and co-facilities. The enforcement discretion was set to expire on December 31, 2022. We anticipate that a forthcoming proposed rule, scheduled for January… (Llamas, December 5, 2022) #Insurance Reform, #Transparency

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Agency Reminds Hospitals of Duty to Protect Staff and Patients from Workplace Violence

Agency Reminds Hospitals of Duty to Protect Staff and Patients from Workplace Violence

The Centers for Medicare & Medicaid Services (CMS) released a Quality, Safety & Oversight memo on workplace violence in hospitals. The memo reiterated the regulatory obligation Medicare certified hospitals have under the Medicare Hospital Conditions of Participation (CoP) (§482.13(c)(2)), including the Medicare Hospital Emergency Preparedness CoP (§482.15(a)). Briefly, the agency highlights the following expectations:   Adhere to current standards of… (Testa, November 28, 2022) #Hospitals, #Program Integrity

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Updated Clinical Guideline for Prescribing Opioids for Pain Released

Updated Clinical Guideline for Prescribing Opioids for Pain Released

The Centers for Disease Control and Prevention (CDC) issued clinical practice guideline for prescribing opioid for pain. The 2022 edition updates and expands the 2016 version and provides evidence-based recommendation for clinicians who provide pain care, including those prescribing opioids, for acute pain, subacute pain, and chronic pain. The guideline provides recommendations in the following areas: Determining whether or not… (Slifer, November 18, 2022) #Opioids

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FNS Proposes Changes to WIC Food Packages

FNS Proposes Changes to WIC Food Packages

The Department of Agriculture (USDA) Food and Nutrition Service (FNS) released a proposed rule with changes to the food packages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) (proposed rule; press release). The updates reflect science-based revisions and incorporate recommendations from the National Academies of Science, Engineering, and Medicine (NASEM) and the Dietary Guidelines for Americans,… (McClurg, November 18, 2022) #Nutrition, #Pediatrics

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Task Force Releases Annual Report on High-Priority Evidence Gaps Focused on Healthy Behaviors

Task Force Releases Annual Report on High-Priority Evidence Gaps Focused on Healthy Behaviors

The US Preventive Services Task Force (USPSTF) released its annual Report to Congress on high-priority evidence gaps for clinical preventive services. USPSTF is an independent, volunteer panel of experts that makes recommendations about preventive services. This report focuses on research gaps related to promoting healthy behaviors across the lifespan, especially for individuals in Black, Hispanic and Latino, American Indian and… (McClurg, November 17, 2022) #Chronic Diseases, #Primary Care

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