BMTA News Recent Symposiums David Barone, Principal of BMTA, has recently participated as a panelist…
2025 December Newsletter
| Happy Holidays! Best wishes for Peace, Health, and Prosperity for you, your family, and your organization. David Barone, Zvi Ladin and the team at Boston MedTech Advisors |
Reimbursement Updates
| Important 2026 Update on RTM Billing Codes As of January 1, 2026, the Centers for Medicare & Medicaid Services (CMS) has expanded and revised the Remote Therapeutic Monitoring (RTM) code set, offering new flexibility that healthcare providers and device manufacturers should note. What changed: – New RTM device-supply codes (CPT 98984-98985) allow billing when patients transmit data 2-15 days in a 30-day period (in addition to the existing 16-30 day codes). – A new treatment management code (CPT 98979) allows billing for shorter monthly check-ins (10-19 minutes/month) – useful for brief remote interactions, data reviews, or quick follow-ups that wouldn’t meet the old 20-minute minimum. Lower data-transmission thresholds expand the potential user base for RTM devices (including wearables, sensors, or therapeutic tracking tools), making these products viable in more clinical scenarios – from short-term rehab to follow-up care. CMS 2026 OPPS / ASC Final Rule: Key Updates On November 21, 2025, CMS released the 2026 final rule for the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System, with several important changes effective January 1, 2026. In addition to an overall 2.6% payment increase, the list of procedures eligible to be performed in ASCs has been expanded significantly, with CMS revising criteria and adding several hundred procedures. The agency is also phasing out the Inpatient-Only (IPO) list over the next three years, with many musculoskeletal, cardiovascular, and other services shifting to outpatient and ASC settings. CMS also finalized updates to packaging and separate payment for certain items and services. As a result, practices and facilities should revisit supply-bundling policies and separate-payable determinations (e.g., skin substitutes) to ensure that coding and billing processes align with the new payment structure. BMTA helps manufacturers and providers develop reimbursement strategies for new and existing technologies. |
Regulatory Updates
| FDA Updates Small Business Fee Waiver Program for FY2026 FDA has updated its Reduced or Waived Medical Device User Fees program with new guidance detailing timing, submission windows, and administrative procedures for Fiscal Year 2026. Notably, the agency introduced a waiver for the Annual Establishment Registration Fee for qualifying small businesses beginning in FY2026. Companies with gross receipts or sales of no more than $30 million may continue to receive a first premarket application fee waiver, while those with less than $1 million in receipts and demonstrated financial hardship may now qualify for a registration fee waiver if they paid the prior year’s fee. While the updated guidance expands access to fee relief, it also introduces tighter deadlines and added administrative hurdles. FDA Enhances Safety Transparency Through Real-Time Reporting and Expanded Recall Communications FDA continues to strengthen its postmarket safety infrastructure through two major initiatives. On August 22, 2025, the agency began publishing adverse event data from its FDA Adverse Event Reporting System (FAERS) on a daily basis, marking a shift toward real-time public reporting. FDA is also seeking vendors to develop a modernized Adverse Event Management system to consolidate multiple legacy reporting tools and streamline data access. In a related move, on September 29, 2025, the Center for Devices and Radiological Health (CDRH) expanded its communications pilot to include all medical devices, aiming to improve the timeliness and clarity of recall and safety alerts. Together, these actions underscore FDA’s broader effort to enhance transparency, accelerate safety communications, and ensure stakeholders receive timely, centralized access to critical product information. FDA Publishes Guidance on Computer Software Assurance for Production and Quality System Software On September 24, 2025, the FDA released final guidance designed to help manufacturers ensure software used in production or quality systems complies with the Quality System regulation. This guidance supersedes the “Section 6” portion of the older “General Principles of Software Validation” guidance. Recognizing that software testing alone is often insufficient to establish confidence in software fitness, the guidance emphasizes a risk-based “software quality assurance” approach focused on preventing defects during development. By applying a risk-based methodology, manufacturers can better target quality assurance activities, ensure product quality, and meet validation requirements while fostering the adoption of innovative technologies. BMTA supports manufacturers in compliance with FDA requirements including risk-based software for quality assurance and medical device safety reporting. |
| About Boston MedTech Advisors Since 2004, BMTA’s multidisciplinary team of highly experienced consultants has supported more than 400 medical technologies and life sciences companies around the world to achieve their business goals. BMTA offers valuable, ethical, result-oriented, professional, and cost-effective insights that recognize the multi-faceted aspects of today’s healthcare markets and the client’s unique business needs. Market Analysis and Business Strategy Business Development Regulatory Affairs and Clinical Trial Management Reimbursement and Contracting Strategies Financing SupportOther Services Boston MedTech Advisors provides practical business services to: Established and growing medical technology companiesHealthcare providersStartups and entrepreneursPrivate and institutional investors |
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