Executive Summary
The Centers for Medicare & Medicaid Services (CMS) is instituting a new round of competitive bidding for Durable Medical Equipment (DME), following the conclusion of the previous program in 2023. This fresh restart introduces significant structural changes, most notably transitioning from a regionalized model to a nationalized framework. Targeting a full implementation date of January 1, 2028, the program aims to consolidate suppliers and reduce reimbursement rates across five specific product categories.
Key takeaways for industry stakeholders include:
- Nationalized Supply Chains: Contracts will be awarded to a small number of national suppliers rather than regional providers.
- Pricing Compression: Reimbursement rates are expected to drop significantly, determined by the 75th percentile of winning bids.
- Heightened Compliance Burdens: All DMEs, regardless of their participation in competitive bidding, are now subject to annual reaccreditation, a shift from the previous three-year cycle.
- Operational Shifts: The introduction of a Remote Item Delivery program allows for direct drop-shipping of products, reducing the need for on-site clinicians for the selected categories.
Core Framework of the New Competitive Bidding Program
The upcoming round of competitive bidding represents a departure from historical operations. Under standard operations, physicians send orders to any DME capable of supplying the product. Under the new competitive bidding rules, DMEs must bid on contracts for the right to carry specific products.
Transition from Regional to National
Previously, competitive bidding was regionalized (e.g., specific suppliers for the Southwest or Southeast). The new program is nationalized. CMS will award contracts to a limited number of suppliers who will service the entire country.
Remote Item Delivery Program
To ensure patient access despite the limited number of national suppliers, CMS is instituting a remote item delivery model. This allows DMEs to drop-ship products directly to patients across state lines without a direct physical interface or on-site setup. Although it is not confirmed why these product categories were chosen, CMS most likely selected the five impacted categories because they believe these items do not require an on-site professional, such as a respiratory therapist, for setup or patient education.
Impacted Product Categories & Pricing Mechanics
CMS has identified the initial categories subject to these competitive bidding rules. The bidding process utilizes a lead item strategy to determine reimbursement for an entire category of products.
Subject Product Categories
| Included Items |
Estimated Contracts |
| Class II Continuous Glucose Monitors and Insulin Pumps |
10 |
| Hydrophilic Urinary Catheters |
10 |
| Off-the-Shelf (OTS) Back Braces |
3 |
| OTS Knee Braces |
4 |
| OTS Upper Extremity Braces |
5 |
| Ostomy Supplies |
6 |
| Urological Supplies |
5 |
The numbers above represent expected contract awards. CMS may award additional contracts to support small suppliers and meet beneficiary demand.
The Lead Item Bidding Process
Suppliers do not bid on every individual HCPCS code within a category. Instead:
- Lead Item Selection: DMEs bid on a single flagship or high-cost item within a category.
- Fixed Ratios: CMS has predetermined the price ratio of the lead item to all accessory or secondary items in that category.
- Automatic Adjustments: When a DME submits a bid for the lead item, the prices for all related HCPCS codes in that category automatically adjust based on CMS's fixed ratios. There is no wiggle room for manufacturers if costs increase; the reimbursement remains fixed to the lead item's bid.
- Setting the Rate: The standard reimbursement rate for the program is set at the 75th percentile of all winning bids.
Primary Lead Items & Maximum Bid Thresholds
| Product Category |
Lead Item |
Bid Limit |
| Class II Continuous Glucose Monitors (CGMs) and Insulin Pumps |
A4239 |
$273.28 |
| Hydrophilic Urinary Catheters |
A4296 |
$8.86 |
| Ostomy Supplies |
A4385 |
$7.28 |
| Off-the-Shelf (OTS) Back Braces |
L0651 |
$855.26 |
| Off-the-Shelf (OTS) Knee Braces |
L1852 |
$691.80 |
| Off-the-Shelf (OTS) Upper Extremity Braces |
L3916 |
$591.58 |
| Urological Supplies |
A4352 |
$8.86 |
Operational Changes & Compliance Requirements
The new program introduces stricter administrative oversight and changes to how businesses qualify for contracts.
Annual Reaccreditation
In a significant regulatory shift, all DMEs, not just those winning competitive bids, must now reaccredit every year. Previously, this thick packet of documentation justifying a business license was required only every three years. This change increases the administrative burden on DMEs and heightens the risk of audits.
Eased Financial Documentation for Bidders
Unlike previous rounds that required extensive tax returns and balance sheets, CMS now generally accepts a credit report as sufficient proof of business viability for the bidding process.
Small Supplier Networks
To mitigate the risk of large national entities monopolizing the market, CMS is allowing small supplier groups. This allows multiple regional DMEs to form a network and submit a collective bid, acting as a single large entity to compete for national contracts.
Strategic Market Outlook & Challenges
The industry anticipates significant friction as the 2028 implementation date approaches.
- Race to the Bottom: Because contracts are awarded based on the lowest bids, there is intense pressure on margins.
- Supplier Displacement: If a DME currently supplying a product doesn’t win a bid, they lose the legal right to supply that product to Medicare patients. Patients would then have a six-month window to transition to a contracted national supplier.
- Lobbying and Pushback: Organizations such as AAHomecare and VGM are actively lobbying Congress to return to a regionalized structure. Concerns center on patient continuity of care and the belief that local DMEs provide better service than national drop-ship providers.
- The Compliance Imperative: With annual reaccreditation and the threat of lower margins, DMEs are prioritizing audit protection and documentation accuracy. Success in this landscape requires having all ducks in a row regarding hard documentation to satisfy CMS requirements.
Program Timeline
The following timeline reflects the current targets established by CMS:
| Date |
Milestone |
| February 27, 2026 |
Start of a six-month moratorium (no new DMEs allowed to open; no acquisitions permitted). |
| June 4, 2026 |
CMS released initial bid information and the lead item calculator. |
| Late Spring / Early Summer 2026 |
Lead items for each category officially announced. |
| Late Summer 2026 |
Bidder registration scheduled to open for DMEs. |
| Late Fall 2026 |
Bid window opens |
| Late Summer / Early Fall 2027 |
CMS announces winning suppliers and Single Payment Amounts (SPAs). |
| January 1, 2028 |
Target date for the program to take full effect. |