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February 2022 State Regulatory Developments

New Jersey Healthcare Blog

For 2023 the healthcare cost growth benchmark is 3.5%, for 2024 3.2%, for 2025 3%, for 2026 2.8%, for 2027 2.8%. 203(a), the Office of the Governor issued Executive Order 280 declaring that a Public Health Emergency, established in Exec Order No. On February 7, 2022, at 54 N.J.R. 103, continues to exist in NJ. 13:34-13.1(d),

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From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

Hall Render

Stage 2: Effective May 6, 2026 Two years after the Final Rule’s publication, the FDA will expand its regulatory scope to include establishment registration and listing, labeling and investigational use requirements. Part 820), providing added oversight over the quality management of LDTs.

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CMS Approves a New 1115 Waiver Amendment:  The New York Health Equity Reform (NYHER) Program

NY Health Law

That application, which is the successor to the state’s Delivery System Reform Incentive Payment (DSRIP) Program that expired in March 2020, was first described in a concept paper issued by the Department of Health (DOH) in August 2021, and was filed with CMS in September 2022.

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Healthcare Reforms Under the IRA: Expanding Access to Care

Healthcare Law Blog

After 2026, the timing for publication is standardized – the February 1 st two years prior to the price applicability date will be the drug publication date. Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Negotiation-Eligible Drugs.

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Health Provider News

Hall Render

Vincent, Indianapolis Colts announce new partnership Franciscan Health launches 24/7 ambulance to help patients in rural counties Lilly to make $1.8B Federal Grant to Study Eye Disease UAMS Study to Address Maternal, Infant Deaths with $2.4M

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.

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SQA Regulatory Surveillance Summary for May and June 2024

SQA

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

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