FDA Finalizes Rule on Laboratory-Developed Tests
What’s happening: The Food and Drug Administration (FDA) finalized a regulation of laboratory-developed tests (LDTs), effective July 5.
What else to know: The final rule amends FDA regulations to make explicit that in vitro diagnostic (IVD) products, which include LDTs, are devices under the Federal Food, Drug, and Cosmetic Act.
CMS Finalizes Rule on Access to Medicaid Services
What’s happening: The Centers for Medicare & Medicaid Services (CMS) finalized a rule meant to improve access to care and services for the people enrolled in the Medicaid program.
What else to know: The rule is effective July 9.
CMS Finalizes Medicaid Managed Care Rule on Access, Finance, and Quality
What’s happening: The Centers for Medicare & Medicaid Services (CMS) finalized the Medicaid and Children’s Health Insurance Program Managed Care Access, Finance, and Quality rule.
What else to know: The rule finalizes significant changes and clarifications regarding managed care delivery and finance.
CMS Finalizes Skilled-Nursing Facility Staffing Standards
What’s happening: The Centers for Medicare & Medicaid Services (CMS) issued a final rule establishing new staffing standards for long-term care facilities, including skilled-nursing facilities (SNFs) and SNFs operated as distinct-part units of acute care hospitals.
What else to know: The regulations are effective June 21. Compliance with overall ratios is required beginning May 2026.
HRSA Implements Long-Awaited Dispute Resolution Process
What’s happening: The Health Resources and Services Administration (HRSA) finalized requirements and procedures for the 340B Drug Discount Program’s administrative dispute resolution (ADR) process.
What else to know: The regulation is effective June 18.
Summary: FFY 2025 Inpatient Psychiatric Facility Medicare Payment Proposed Rule
What’s happening: A summary of the inpatient psychiatric facility (IPF) prospective payment system (PPS) proposed rule is available.
What else to know: Comments on the proposed rule are due by May 28.
CMS Proposes Inadequate Inpatient Payment Update
What’s happening: The Centers for Medicare & Medicaid Services’ (CMS) proposed fiscal year (FY) 2025 inpatient prospective payment system (IPPS) rule falls short of what hospitals need to keep up with rising costs and health care needs.
What else to know: The rule includes a net market basket update of 2.6%. As a result of all proposed changes, CMS estimates that hospital inpatient payments will increase by $3.2 billion in FY 2025. Comments are due June 10.
CHA-Opposed “Neglect” Bill Not Moving Forward This Year
What’s happening: A CHA-opposed Assembly bill that would have expanded the definitions of elder abuse and neglect will not move forward this year.
What else to know: Assembly Bill (AB) 2800 (Kalra, D-San Jose) would have expanded the types of conduct that constitute elder abuse and lowered the standard of proof a plaintiff must meet to recover on such claims. CHA’s opposition to this bill centered on its undermining of the stabilizing influence of the Medical Injury Compensation Reform Act (MICRA).
Summaries: FFY 2025 Hospice, Inpatient Rehabilitation Facility, Skilled-Nursing Facility Medicare Payment Rules
What’s happening: Summaries of the hospice wage index, inpatient rehabilitation facility (IRF) prospective payment system (PPS), and skilled-nursing facility (SNF) PPS proposed rules are now available.
What else to know: Comments on the proposed rules are due by May 28.
Summary: Finalized Policy Changes for MA Plans in Contract Year 2025
What’s happening: A summary of the finalized changes to Medicare Advantage (MA) and Part D programs for contract year 2025 is now available.
What else to know: The regulation is effective June 3.