CMS has finalized a significant expansion of the 36-month rule that will apply to all DMEPOS suppliers, beginning January 1, 2026.
While the rule itself has existed in various forms, its broader application introduces new compliance considerations for suppliers across the DMEPOS landscape.
The DME 36-month rule establishes expectations around supplier stability, enrollment continuity, and operational consistency over a defined period. With the 2026 effective date, CMS will apply this framework uniformly rather than limiting its impact to select scenarios. For many suppliers, this requires earlier planning and closer attention to enrollment and ownership records.
Understanding how the rule works and how it intersects with existing CMS oversight programs is essential well before enforcement begins.
What is the Purpose of the DME 36-Month Rule?
The DME 36-month rule is designed to reduce fraud, abuse, and instability among DMEPOS suppliers. CMS uses the rule to evaluate whether a supplier has demonstrated sustained operations and compliance over time.
Rather than assessing suppliers based on isolated snapshots, CMS reviews activity across a rolling 36-month window. This approach places greater emphasis on continuity and transparency and less tolerance for unexplained changes or gaps in enrollment.
The rule applies regardless of supplier size or product focus. Its intent is to establish a baseline expectation of operational stability.
So, What Changes Take Effect on January 1, 2026?
Beginning January 1, 2026, the DME 36-month rule applies to all DMEPOS suppliers. This expansion increases the number of suppliers subject to enrollment and stability review.
Key elements of the expanded rule include:
- Uniform applicability across all DMEPOS suppliers
- Greater scrutiny of enrollment timelines
- Increased review of ownership and control changes
- Stronger linkage between operational continuity and billing eligibility
Suppliers that previously experienced minimal impact from the rule will now need to incorporate it into compliance planning.
Enrollment and Revalidation Impact
Enrollment and revalidation processes are directly affected by the DME 36-month rule. CMS evaluates whether suppliers have maintained continuous enrollment and compliant operations over the preceding 36 months.
This evaluation can influence:
- Initial enrollment approvals
- Revalidation timelines and outcomes
- Location additions or closures
- Supplier billing privileges
Inaccurate or incomplete enrollment records increase the likelihood of delays or requests for additional information. Suppliers should ensure that all CMS enrollment data reflects actual operations.
Ownership and Structural Changes
Ownership changes present increased compliance risk under the expanded rule. CMS reviews whether changes in ownership or control disrupt operational continuity or introduce new risk factors.
Suppliers considering mergers, acquisitions, or restructuring should evaluate how timing and documentation affect their 36-month compliance profile. Poorly documented or closely timed changes can complicate enrollment reviews and interrupt billing.
Advanced planning helps reduce disruption and ensures that transactions align with CMS expectations.
Operational Continuity Expectations
The rule reinforces CMS’s focus on sustained operations. Interruptions, unexplained closures, or inconsistent documentation can raise questions during review.
Suppliers should maintain:
- Continuous enrollment for each business location
- Current licensure and accreditation
- Consistent operational documentation
- Accurate reporting of changes
Operational discipline reduces the likelihood of adverse enrollment actions or compliance findings.
Documentation and Record Retention
As CMS expands application of the rule, documentation expectations increase. Suppliers must be able to demonstrate compliance across the full 36-month window.
This includes maintaining records related to enrollment, ownership, accreditation, and business operations. Fragmented or manual recordkeeping makes it difficult to respond to CMS requests efficiently.
Centralized record management supports timely and accurate responses during enrollment or audit reviews.
Relationship to Other CMS Oversight Programs
The DME 36-month rule intersects with accreditation requirements, revalidation cycles, and audit activity. Issues identified during enrollment review may trigger additional scrutiny elsewhere.
Suppliers should view the rule as part of a broader compliance framework. Consistency across enrollment, billing, and operational practices reduces cumulative risk.
Preparing Before the 2026 Effective Date
If possible, preparation should begin well ahead of January 1, 2026. Because CMS reviews historical data, late corrections may not fully mitigate risk.
Preparation efforts typically include:
- Reviewing enrollment histories for accuracy
- Documenting ownership and control changes
- Verifying accreditation and licensure continuity
- Establishing internal compliance review processes
Early action allows time to identify and address gaps.
Risks of Delayed Preparation
Suppliers that delay preparation may encounter enrollment delays, billing interruptions, or heightened scrutiny once enforcement begins. Because CMS evaluates prior activity, issues close to the effective date may be difficult to resolve quickly.
The expanded rule rewards transparency and stability over time.
The Bottom Line
The expansion of the DME 36-month rule effective January 1, 2026, represents a meaningful shift in CMS oversight of DMEPOS suppliers. While the rule itself is familiar, its broader application increases the importance of enrollment accuracy, ownership transparency, and operational continuity.
Suppliers that maintain consistent records and plan structural changes carefully are better positioned to navigate the transition without disruption. Those that treat enrollment and compliance as periodic tasks face higher operational risk.
The DME 36-month rule reinforces CMS’s expectation that supplier stability is demonstrated continuously vs intermittently.
