December 13, 2025 This week Antitrust Centers for Medicare & Medicaid Services Data Privacy and Breach HIPAA Non-Competes Telehealth Antitrust U.S. Judge Jeffrey Cummings denied the Federal Trade Commission’s request to block GTCR LLC’s $627 million acquisition of Surmodics Inc. on November 10. The FTC, joined by Illinois and Minnesota, argued the merger would give GTCR control of more than 50% of the U.S. outsourced hydrophilic coatings market, as GTCR already owns Biocoat, the second...
11 days ago • 4 min read
December 13, 2025 This week 340B Artificial Intelligence Cybersecurity Drugs & Devices Fraud & Abuse Hospitals Medicare Part 2, Substance Abuse Workforce 340B HRSA has approved plans from 10 manufacturers to participate in the 340B Rebate Model Pilot Program, which will inform the development of future models consistent with the 340B statute. The participating manufacturers include Bristol Myers Squibb (Eliquis), Immunex Corporation (Enbrel), AstraZeneca (Farxiga), Pharmacyclics (Imbruvica),...
18 days ago • 10 min read
December 13, 2025 This week 340B Anti-Kickback Statute Data Privacy & Governance Drug & Device Fraud & Abuse HIPAA Medicare & Medicaid Mergers & Acquisitions Mobile Devices Pharmacy Benefit Managers Revenue Cycle Management Substance Use Disorder (42 CFR Part 2) Workplace 340B 340B covered entities face new rebate models and Medicare Part D claims reporting requirements starting January 1, 2026. The rebate models extend to all 340B covered entity types, all payors, and all dispensing...
25 days ago • 10 min read
December 13, 2025 This week 340B Artificial Intelligence Breach Notification Compliance Programs Drugs & Devices False Claims Act Gender-Affirming Care HIPAA Medicaid Physician Fee Schedule Reproductive Rights Rural Hospitals Weight Loss and GLP-1 340B HRSA has finalized the 340B Rebate Model Pilot Program with nine manufacturers approved to participate starting January 1, 2026. The approved manufacturers include Bristol Myers Squibb, Immunex Corporation, AstraZeneca AB, Pharmacyclics, Merck...
about 1 month ago • 8 min read
December 13, 2025 This week Cybersecurity Drugs and Devices Laboratories Mergers & Acquisitions Private Equity Reproductive Rights Cybersecurity Healthcare remains the sector with the costliest data breaches, with incidents averaging $7.42 million in damages and marking the 12th consecutive year the industry topped breach costs. Health records sell for up to $250 on the dark web. It is projected that ransomware will impact 40% of US healthcare systems by 2026, causing care delivery...
about 1 month ago • 6 min read
December 13, 2025 This week Artificial Intelligence Civil Investigative Demands Compliance Data Privacy Fraud & Abuse GLP-1 Marketing Medicare Reimbursement Mergers & Acquisitions Value-Based Care Wearables Artificial Intelligence Insurance companies face lawsuits alleging AI algorithms denied patient care without human oversight. UnitedHealth Group, Cigna, and Humana are defending against claims that their AI programs led to denied care, though the companies deny using AI for coverage...
about 2 months ago • 8 min read
December 13, 2025 This week AI Governance Biotech Cybersecurity Federal Drug Administration Fraud & Abuse GLP-1 Intellectual Property Private Equity & Startups Medicaid Reimbursement Telehealth Texas Medical Board AI Governance Joint Commission and the Coalition for Health AI released the first national guidance for responsible AI implementation in U.S. healthcare systems. The guidance establishes policies for local validation, monitoring, and use that healthcare organizations can integrate...
about 2 months ago • 10 min read
December 13, 2025 This week AI Governance Antitrust Cybersecurity Data Breach Data Privacy Devices Enforcement Fraud & Abuse HIPAA Joint Ventures Medicare Reimbursement Mergers & Acquisitions Regenerative Medicine Reproductive Rights Tariffs & Taxation AI Governance Health systems possess the expertise to monitor AI tools but lack the infrastructure to implement comprehensive governance at scale. The Joint Commission and Coalition for Health AI released guidance covering AI policies, data...
2 months ago • 13 min read
December 13, 2025 This week Complementary and Alternative Medicine Devices & Wearables Emerging Tech Fraud & Abuse HIPAA Marketing Medicare Advantage Mergers & Acquisitions Patient Safety Pharmaceuticals Telehealth Complementary and Alternative Medicine Texas Medical Board now requires physicians to obtain structured consent before providing complementary and alternative medicine therapies. Effective January 2025, the rules apply to any non-conventional treatment including peptides, stem...
2 months ago • 8 min read