Home
»
Market Trend Reports
»
Durable Medical Equipment-Monthly Monitoring Report

Durable Medical Equipment - Monthly Monitoring Report

Published: Nov, 2025
Report ID: GVR-MT-100490
Format: PDF/Excel databook

No. of Pages/Datapoints: 60
Report Coverage: 2024 - 2030

Objective:

To provide a subscription-based monthly monitoring service that tracks key trends and developments in the durable medical equipment market, including product approvals, HCPCS code updates, indication changes, FDA submission and approval timelines, and evolving market trends. The subscription can be customized based on client interest or specific research requirements.

Comparison of Key Provisions and Policy Shifts Between CY 2026 Proposed and CY 2024 Final Medicare (U.S.)

Section	CY 2026 Proposed Rule	CY 2024 Final Rule	Key Difference / Summary
Objective	Proposes updates to the Medicare Home Health Prospective Payment System (HH PPS) for CY 2026, including payment adjustments, behavioral modifications, and technical policy updates.	Finalizes routine updates to Medicare Home Health payment rates for CY 2024 in line with statutory requirements.	CY 2026 focuses on proposed policy refinements; CY 2024 finalized payment and regulatory codifications.
Payment Methodology	Introduces permanent and temporary behavioral adjustments, recalibrates case-mix weights, updates LUPA thresholds, functional impairment levels, and comorbidity subgroups.	Finalizes market basket rebasing, labor-related share revision, and payment-related adjustments to HH PPS rates.	CY 2026 emphasizes recalibration; CY 2024 focused on rate finalization.
Behavioral Adjustments	Proposes continued evaluation and permanent adjustment mechanisms for PDGM behavioral assumptions.	Implements finalized behavioral adjustment of –2.89% for CY 2024.	CY 2026 re-evaluates methodology; CY 2024 completed adjustment implementation.
Home Health QRP (Quality Reporting Program)	Proposes removal of COVID-19 vaccine measure and certain assessment items; updates reconsideration policies; introduces feedback on digital quality measures (dQMs) and FHIR adoption.	Finalizes inclusion of two new quality measures, establishes 90% OASIS data threshold, and updates HH QRP reporting structure.	CY 2026 moves toward digital modernization; CY 2024 finalized existing data and measure requirements.
Home Health Value-Based Purchasing (HHVBP)	Proposes additional measure removal/addition, revised weighting, and feedback on new performance metrics.	Finalizes updates to HHVBP model baseline year and measure composition.	CY 2026 extends measure development and refinement; CY 2024 solidified program implementation.
Conditions of Participation (CoPs)	Proposes minor technical revisions aligning with all-payer OASIS data submission.	Finalizes similar OASIS technical clarification.	CY 2026 continues technical alignment.
Provider & Supplier Enrollment	Proposes enhanced screening, expanded revocation grounds, and clarifies Medicaid enrollment standards.	Finalizes stricter screening, including ownership verification and shortened deactivation periods.	CY 2026 strengthens enforcement and compliance authority; CY 2024 finalized structural reforms.
DMEPOS Competitive Bidding Program (CBP)	Proposes administrative and technical updates to improve CBP implementation.	Finalizes inclusion of lymphedema compression treatment items in CBP.	CY 2026 updates administrative structure; CY 2024 expanded coverage scope.
DMEPOS Refill Policy	Proposes clarification of beneficiary confirmation and refill timelines.	Finalizes DMEPOS refill documentation and beneficiary affirmation requirements.	CY 2026 strengthens policies finalized in CY 2024.

Source: FederalRegister.gov

Key Impact

CY 2026 Proposed Rule: Focuses on behavioral recalibration, digital reporting transitions, and expanded DMEPOS compliance and accreditation frameworks.
CY 2024 Final Rule: Focused on implementation and codification - introducing new benefits, hospice oversight, and DMEPOS documentation standards.
Overall Trend: CMS is moving from policy establishment (2024) to program optimization and modernization (2026).

On 30 June 2025, the Australian Government introduced new TGA regulations to strengthen medical device patient safety. Since March 2026, all hospitals must report medical device-related injuries to the TGA, improving the early detection of safety issues. The Unique Device Identification (UDI) System, mandatory for implanted devices from July 2026, will require manufacturers to include barcodes on packaging and submit product data to the TGA, enhancing traceability and patient transparency through integration with hospital systems and the MyHealth Record. New recall procedures have also been introduced to simplify and accelerate product safety actions. These reforms collectively improve device tracking, patient safety, and regulatory responsiveness in Australia.

“I encourage all healthcare facilities, surgeons and GPs to explore the powerful capabilities of UDI and the valuable opportunities it presents for enhancing patient care and clinical data systems. UDI is set to play a vital role in empowering patients with full transparency regarding their medical devices, ultimately supporting safer and more informed healthcare decisions”.- Professor Robyn Langham, Chief Medical Advisor with the TGA.

Key Impact on the Market

The UDI system, which will be mandatory from July 2026, will require all DME manufacturers and suppliers to label products with standardized identifiers. This will improve traceability across the supply chain and boost patient and provider confidence.
Manufacturers and distributors will face additional costs for barcode integration, database submissions, and compliance audits, which will influence pricing strategies and procurement dynamics.
Smaller or non-compliant suppliers may exit the market due to regulatory burdens, while established players investing in regulatory readiness and data systems will gain a competitive edge.
Greater transparency through public UDI databases and improved recall systems will enhance patient trust in DME devices, supporting brand reputation and adoption of high-quality products.

Comprehensive Coverage of Recent HCPCS Code Revisions within the DME Monthly Monitoring Report

With CMS continually updating and revising HCPCS codes such as the new wheelchair accessory codes effective April 2025 the durable medical equipment (DME) monthly monitoring report provides critical insights to help industry professionals stay ahead of change.

This report tracks monthly updates in coding, reimbursement, and regulatory trends, ensuring manufacturers, distributors, and healthcare providers can respond quickly to new compliance requirements.

By monitoring these developments, valuable insights:

Proactive awareness of new and revised HCPCS codes
Improved billing accuracy and reduced claim denials
Timely insights into market and policy shifts affecting DME categories
Strategic visibility for portfolio planning and pricing decisions

The DME monthly monitoring report transforms complex regulatory updates into intelligence, helping maintain compliance, protect revenue, and stay competitive in a rapidly evolving reimbursement environment.

Effective Date: April 1, 2025

HCPCS Code	Description (Updated/New)	Type of Change	Notes
E1028	Wheelchair accessory, manual swing away, retractable or removable mounting hardware, other	Revised	Existing code description updated; use for ongoing capped rentals prior to April 1, 2025
E1032	Wheelchair accessory, manual swing away, retractable or removable mounting hardware used with joystick or other drive control interface	New	Bill only for new items dispensed on or after April 1, 2025
E1033	Wheelchair accessory, manual swing away, retractable or removable mounting hardware for headrest, cushioned, any type	New	Included in capped rental payment category
E1034	Wheelchair accessory, manual swing away, retractable or removable mounting hardware for lateral trunk or hip support, any type	New	Included in capped rental payment category

Source: CMS – Joint DME MAC Publication

Conclusion:

The April 2025 HCPCS code revisions for wheelchair accessories are expected to improve billing accuracy, simplify reimbursement processes, and reduce claim rejections. By enhancing coding clarity and alignment with product use, these updates will strengthen compliance, increase operational efficiency, and support more transparent pricing and procurement across the DME market.

Monthly Moniteriang Update September, 2025

GVR Added Date

Product Manufacturer

Product Name

Device Category

Device Sub-Category

Device Class*

Old HCPC (if known)

New HCPC code

Product description

Indication

Market Surveillance Notes

Market Potential -2022 (in millions)

Similar Products

FDA Submission Date

FDA Submission Type

FDA / Market Status

FDA Expected/Approval Date

10/15/25

Dongguan E-test Technology Co., Ltd

Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

Monitoring and Therapeutic Devices

Other’s Equipment

Class II

A4670

No Change

The Automatic Upper Arm Blood Pressure Monitor uses a non-invasive oscillometric method with an electronic pressure sensor to measure systolic, diastolic pressure, and pulse rate. It features Bluetooth for data transfer to an app, which can also control measurements. The device alerts users to low battery and supports power via 4 AA batteries or a DC 6.0V adapter. There are 18 models: 13 arm-type (BA-831X to BA-855X) and 5 tunnel-type (BA-835 to BA-856), differing only in appearance and cuff size. Arm-type models come with 6 cuff sizes to fit various arm circumferences.

The Automatic Upper Arm Blood Pressure Monitor is designed for medical or home use to measure and display systolic, diastolic blood pressure, and pulse rate in adults using a cuff on the left upper arm.

Dongguan E-test Technology Co., Ltd. (TST Testing) is a major third-party testing and certification body that provides comprehensive "one-stop" quality monitoring and testing services, covering a wide range of industries including electronics, textiles, and consumer products, holding numerous international accreditations

$4,500.00

DONGGUAN E-TEST TECHNOLOGY CO., LTD/Automatic Upper Arm Blood Pressure Monitor
Model: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819

1-Aug-25

510(k) premarket notification

Approved

3-Sep-25

10/15/25

AViTA Corporation

AViTA Arm Type Blood Pressure Monitor Cuff

Monitoring and Therapeutic Devices

Other’s Equipment

Class II

A4663

No Change

The AViTA blood pressure cuff features an inflatable bladder and a fabric outer layer with a hook-and-loop fastener. It wraps securely around the upper arm for accurate measurements with AViTA monitors.

The cuff is a reusable, non-sterile accessory for non-invasive blood pressure monitors, intended for adult use by both healthcare professionals and laypersons at home.

The company is a Taiwan-based specialist in the R&D and manufacturing of electronic medical devices for home care, with core products being thermometers, blood pressure monitors, and nasal aspirators.

$4,500.00

Shenzhen SINO-K Medical Technology Co., Ltd /Reusable NIBP Cuff

4-Aug-25

510(k) premarket notification

Approved

3-Sep-25

10/15/25

Shanghai Berry Electronic Tech Co., Ltd

Pulse Oximeter

Monitoring and Therapeutic Devices

Oxygen Equipment

Class II

E0445

No Change

The BM20 Pulse Oximeter is a compact, lightweight, and portable device for spot-checking SpO2, pulse rate, plethysmogram, PI, and battery status in adults, adolescents, and children. It features low power consumption, a lithium battery, and a battery level display. Designed for use in healthcare facilities or at home under physician supervision, it is reusable but not for continuous monitoring or use during motion or low perfusion.

The Pulse Oximeter is for spot-checking SpO2 and pulse rate in adults, adolescents, and children, used in hospitals and home healthcare settings.

The company is a medical electronics company that focuses on developing and selling monitoring instruments, such as oximeters, patient monitors, and sleep apnea screening devices.

$2,048.91

Beijing Choice Electronic Technology Co., Ltd. /Fingertip Pulse Oximeter

19-Aug-25

510(k) premarket notification

Approved

25-Sep-25

Source: GVR Analysis, FDA, U.S. Department of Health & Human Services

DME monthly monitoring provides an overview of FDA 510(k) cleared medical devices tracked by each month. The update captures regulatory progress and market activities across multiple DME categories, including Monitoring and Therapeutic Devices and Personal Mobility Devices.

The table above highlights recently cleared products such as automatic blood pressure monitors, pulse oximeters, wearable breast pumps, mobility scooters, and electric wheelchairs, along with details on device classification, HCPCS codes, product descriptions, market potential, and expected approval timelines. This compilation reflects the ongoing advancements and compliance efforts undertaken by manufacturers to align with U.S. FDA standards.

The durable medical equipment–monthly monitoring report serves as a strategic resource for manufacturers, distributors, healthcare institutions, investors, and policy stakeholders, offering timely data on:

Regulatory approvals and clearance trends across various device categories
Changes or updates in HCPCS codes relevant to reimbursement policies
Market potential and surveillance insights indicating emerging opportunities
Product innovation patterns influencing competitive positioning

By this report, stakeholders can stay informed of evolving regulatory scenarios, anticipate reimbursement implications, and make data-driven decisions in areas such as product development, market entry planning, and compliance management. Access to continuous monthly updates ensures that industry participants remain aligned with the latest developments shaping the DME market landscape.

Request a Free Sample

GET A FREE SAMPLE

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself.

Or view our licence options:

NEED A CUSTOM REPORT?

We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.