Health & Medical
Medicare, Medicaid, HIPAA, ACA, prescription drugs, and FDA regulation.
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Recent Law Changes
Amendment of Class E5 Airspace Over Elizabeth City, NC
This amendment changes the airspace regulations over Elizabeth City, North Carolina. Previously, there was no specific mention of Class E airspace extending upward from 700 feet above the surface within a 6-mile radius around Sentara Albemarle Medical Center Heliport. Now, this area is designated as part of Class E5 airspace due to new instrument approach procedures for the heliport. This change affects pilots and air traffic controllers operating in or near this airspace. The amendment takes effect on July 9, 2026.
Updated Insurance Requirements for Multi-Family Housing Programs
This law updates insurance requirements under the USDA's Rural Development Multi-Family Housing Direct Loan and Grant programs. Before this change, insurance coverage types, amounts, and deductibles were not aligned with industry standards. Now, these will be adjusted to match affordable housing norms, simplifying coverage and deductible limits for better customer experience. The changes affect those involved in MFH programs, including property owners and tenants. This new rule takes effect on May 20, 2026.
Classification of Circulating Tumor Cell Enrichment Device
This new regulation classifies a medical device called the circulating tumor cell enrichment device into Class II under FDA regulations. Previously, there was no specific classification for this type of device. The special controls identified in this order will ensure its safety and effectiveness. This change affects manufacturers who produce these devices as well as patients who may benefit from improved access to innovative diagnostic tools. It takes effect immediately.
Classification Change for Corneal Storage Medium With Preservatives
The Food and Drug Administration (FDA) has classified corneal storage medium with preservatives including antifungals into class II. This means these devices will now be subject to special controls identified by the FDA, which are designed to ensure their safety and effectiveness. The change is expected to enhance patient access to beneficial innovative devices while reducing regulatory burdens on manufacturers. This classification takes effect immediately.
New Classification for Medical Devices Preserving Microbial Nucleic Acids
The FDA has classified a new type of medical device designed to preserve and stabilize microbial nucleic acids in clinical samples into Class II. This classification means the device will now be subject to special controls, which are detailed regulations aimed at ensuring its safety and effectiveness. The change is expected to enhance patient access to innovative devices by reducing regulatory burdens on manufacturers. This new regulation takes effect immediately.
New Controlled Substances Added to Schedule I
This law adds four new synthetic substances—4F-MDMB-BUTICA, ADB-4en-PINACA, 5F-EDMB-PICA, and MMB-FUBICA—to Schedule I of the Controlled Substances Act. Before this change, these substances were not regulated under federal drug laws. Now, anyone who manufactures, distributes, imports, exports, conducts research or instructional activities with, or possesses these substances will face administrative, civil, and criminal sanctions. This law takes effect immediately.
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