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Commissioners Support Recommendation that Would Allow Medicaid to Leverage Medicare NCDs for Prescription Drugs

The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a session on Medicaid coverage drug coverage based on Medicare National Coverage Determinations (NCDs). Principal Analyst Chris Park offered the following policy recommendation for Commissioner consideration: Congress should amend § 1927(d)(1)(B) of the Social Security Act to allow states to exclude or otherwise restrict coverage of a covered outpatient drug… (Slifer, December 8, 2022) #Coverage Decisions, #Prescription Drugs

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 help health app developers learn about federal regulations that apply to their software. The tool is intended to help developers… (McClurg, December 8, 2022) #Health Information Technology, #Privacy

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

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

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

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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