Billy Wynne

Agencies Launch an Updated Tool for Health App Developers to Learn About Relevant Federal Regulations The Department of Health and Human Services (HHS) Office of Civil Rights (OCR), HHS Office of the National Coordinator for Health Information Technology (ONC), Federal Trade Commission (FTC), and Food and Drug Administration (FDA) jointly created an updated tool to…

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…

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…

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,…

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.…

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…

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…

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…

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…

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…