Compliance, Regulatory Changes 13 Jan 2025 healthcare, health facilities, grant programs-health, hospitals, payment systems, diseases, privacy, medicare, medicaid, health insurance, administrative practice and procedure, reporting and recordkeeping requirements, compliance, regulations

🏥Medicare and Medicaid Payment System Corrections for 2025

This document corrects technical and typographical errors in the final rule with comment period that appeared in the November 27, 2024 Federal Register titled "Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities".

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Grant Opportunities, Financial Assistance 13 Jan 2025 mental health, grant, funding, healthcare, samsha, technical assistance

💰FY 2025 SAMHSA Supplemental Funding Opportunity for Mental Health

This notice is to inform the public that Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements in scope of the parent award for the five (5) eligible grant recipients funded under the FY 2020 National Consumer and Consumer Supporter Technical Assistance Centers, Notice of Funding Opportunity (NOFO) SM-20-001. The total available funding is $1,806,000 and each of the five recipients may receive up to $361,200. This supplemental funding will extend the project period by 12 months to March 30, 2026, as SAMHSA completes the agency's efforts to update the program for the field's current needs. Recipients will use the funding to continue to provide technical assistance to promote evidence-based care for adults with serious mental illness within the scope of their active grant award.

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Compliance, Regulation 13 Jan 2025 compliance, healthcare, regulation, medicare, medicaid, hospice, joint commission, accreditation

🏥Medicare and Medicaid Hospice Accreditation Regulations Notice

This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

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Compliance, Financial Assistance, Regulatory Requirements 10 Jan 2025 healthcare, cms, information collection, federal regulations, rural community hospitals

🏥CMS Proposes Information Collection on Rural Hospital Program

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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Regulatory Compliance, Consumer Trends, Professional Events 10 Jan 2025 healthcare, regulation, medicare, medicaid, chip, virtual meeting, consumer education

🏥Advisory Panel Meeting on Health Education Strategies - Feb 2025

This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg],\1\ Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public. ---------------------------------------------------------------------------

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Regulatory Notice 10 Jan 2025 regulatory compliance, healthcare, information collection, public comment, department of defense

📋Proposed Information Collection by the Department of Defense

In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency (DHA) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

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Compliance, Professional Events 8 Jan 2025 healthcare, regulations, public health, cdc, hepatitis c, diagnostics

🩺CDC's Road Map for Accelerated HCV Diagnosis

The Centers for Disease Control and Prevention (CDC) announces a two-day convening hosted and facilitated by the Association of Public Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders from public health, laboratory, medical, academic, and industry sectors will have the opportunity to provide individual input, without building a consensus, on accelerating the diagnosis of current hepatitis C virus (HCV) infection. Members of the public with interest and expertise in diagnosing HCV infection are also invited to provide individual input. Specifically, the convening will focus on how to leverage the following hepatitis C diagnostic methods: same-day diagnosis and treatment, and viral-first testing. The goal of the convening will be for each person to give their individual input, and not to build consensus. No discussions, recommendations, or advice to CDC will occur or be provided at the meeting. Day 1 will focus on the utility of point-of- care (POC) testing for accelerating same-day HCV diagnosis and rapid treatment i.nitiation. Day 2 will focus on the utility of viral-first testing strategies for accelerating HCV diagnosis and treatment initiation in the United States. Following the meeting, APHL will prepare a meeting report summarizing the discussion and public comment received through regulations.gov, developed and documented as individual input to ensure thorough and complete input from partners. CDC and APHL will disseminate the APHL-prepared report as a reference for partners and industry to follow in developing and implementing future hepatitis C testing strategies. The final report will be added to docket CDC-2025-0002 once it is available.

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Regulatory Compliance, Healthcare Initiative 8 Jan 2025 compliance, healthcare, public health, data collection, cdc, hiv testing

💼Proposed Data Collection on HIV Testing by CDC

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Greater Access and Impact with NAT (GAIN) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point- of-Care Nucleic Acid Tests (NATs). This study will identify facilitators and barriers with implementation of HIV point-of-care (POC) nucleic acid tests (NATs) in clinical settings, estimate the sensitivity and specificity of the HIV POC NAT, and assess the impact of the test in decreased time to receipt of HIV prevention and care.

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Compliance, Regulatory Requirements 8 Jan 2025 compliance, healthcare, information collection, cdc, cancer prevention
Compliance, Regulatory 8 Jan 2025 healthcare, fda, drug development, clinical trials, optical imaging

🩺FDA Draft Guidance on Developing Drugs for Optical Imaging

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.

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