Navigating New York’s Evolving Healthcare Regulations in 2025
The 2025 healthcare landscape in New York is transforming, particularly for medical supplies providers and pharmacies. Emerging laws targeting durable medical equipment (DME), pharmacy benefit manager (PBM) oversight, and automation of dispensing systems are reshaping industry operations. Understanding these changes is critical for ensuring New York compliance, minimizing risk, and maximizing competitive advantage.
This article addresses key regulatory updates affecting your business—from DME audits to automated dispensing—while offering best practices for compliance and adaptability.
PBM Regulation & Durable Medical Equipment
Senate Bill S8098, introduced in May 2025, expands PBM oversight to include durable medical equipment. PBMs must now manage and administer benefits related to DME, comply with DME provider audit rules, and establish clear appeal processes.
Medical supplies companies and pharmacies that provide DME are now subject to greater scrutiny. PBMs are required to disclose cost-sharing obligations, substitution policies, and appeals procedures.
To remain compliant, businesses should:
Review contracts with PBMs for DME-specific clauses.
Implement transparent billing and appeals processes.
Conduct internal audits to monitor PBM practices related to DME reimbursement.
Medicaid Billing for Medical Supplies and DMEPOS
In January 2025, the NYS Department of Health released updated guidance that allows pharmacies and DME providers to bill for certain medical supplies and prosthetics under the NYRx Medicaid program.
This change presents a new revenue opportunity but also brings additional responsibilities. To align with the new guidelines:
Evaluate billing software and workflows for DMEPOS readiness.
Train staff on updated documentation standards and denial resolution procedures.
Ensure pricing structures meet Medicaid program requirements.
Automated Patient Dispensing Systems
Assembly Bill A5999 introduces strict oversight for automated patient dispensing and storage systems (APDSS) across healthcare facilities and pharmacies. These systems may be used to dispense prescribed medications or medical products, but only under regulated conditions.
Requirements include:
Prior patient consent for automated dispensing.
Pharmacist availability and oversight of the system.
Secure systems with camera monitoring and labeling compliance.
Monthly quality assurance reviews and documentation.
To meet compliance expectations:
Develop policies around patient consent, pharmacist involvement, and emergency access.
Train employees on machine operation, data logging, and review protocols.
Monitor and document monthly performance, as required by law.
Material Transactions and Acquisition Oversight
In 2025, the New York Department of Health clarified that pharmacies and medical supply companies are subject to material transaction reporting under Article 45‑A if they meet the $25 million annual gross revenue threshold in New York.
Transactions that fall under this rule include mergers, acquisitions, affiliations, and management service agreements. Businesses must provide 30-day advance notice and submit detailed documentation addressing the impact on cost, access, quality, equity, and competition.
To prepare:
Incorporate regulatory checks into your M&A due diligence process.
Maintain impact reporting templates for quick turnaround.
Monitor proposed legislation that may increase DOH review authority or introduce civil penalties.
Operational Compliance for 2025
Maintaining compliance in today’s regulatory environment requires a coordinated strategy that touches every part of your organization. Below are key recommendations to protect your business:
Focus AreaCompliance ActionsPBM ContractsEnsure DME clauses meet S8098 guidelines.Medicaid BillingUpdate systems to support NYRx DMEPOS billing.Dispensing SystemsEstablish SOPs for patient consent, security, and pharmacist oversight.M&A PlanningIntegrate DOH notification requirements into your transaction workflow.Staff TrainingProvide regular sessions on billing changes, automation rules, and reporting protocols.DocumentationMaintain logs and review checklists for PBM appeals, dispensing system QA, and Medicaid compliance.
Building Long-Term Resilience
New York’s regulatory environment will continue evolving throughout 2025 and beyond. Medical supplies companies and pharmacies that build robust compliance strategies today will be best positioned to succeed tomorrow. Staying informed, updating internal protocols, and adopting secure, transparent systems are essential steps.
We specialize in ensuring medical supplies compliance in New York 2025, guiding pharmacies and DME providers through the latest PBM, Medicaid, automated dispensing, and transaction regulations.
To learn more about how we can support your business, contact us.
