0012 - Blood Glucose Monitors: Medical Necessity and Documentation Requirements

Issue Name
0012 - Blood Glucose Monitors: Medical Necessity and Documentation Requirements
Date
Review Type
Complex
Provider Type
DME Physician/ DME Supplier
MAC Jurisdiction
All DME MACs

Description

When the indications of coverage and/or medical necessity are not met and/or when the item delivered has not been correctly coded according to the Pricing, Data Analysis and Coding (PDAC) contractor, the blood glucose monitor with integrated voice synthesizer (HCPCS code E2100) will be denied.

Affected Code(s)

E2100

Applicable Policy References

1. Title XVIII, Social Security, §1833(e)- Payment of Benefits
2. Title XVIII of the Social Security Act (SSA): §1862(a)(1)(A)- Exclusions from Coverage and Medicare as Secondary Payer
3. Code of Federal Regulations, 42 CFR §405.980 (b) & (c)- Reopening of Initial Determinations, Redeterminations, and Reconsiderations, Hearings and Reviews
4. Code of Federal Regulations, 42 CFR §405.986- Good Cause for Reopening
5. Medicare Program Integrity Manual, Chapter 4- Program Integrity, §4.26- Supplier Proof of Delivery Documentation Requirements
6. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.2.3- Rules Concerning Orders, Detailed Written Orders
7. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.2.8- Rules Concerning Orders, Refills of DMEPOS Items Provided on a Recurring Basis
8. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.3-  Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs)
9. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.7- Documentation in the Patient’s Medical Record
10. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.8- Supplier Documentation
11. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.9- Evidence of Medical Necessity 
12. Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §3.2.3.8- No Response or Insufficient Response to Additional Documentation Requests
13. Medicare Program Integrity Manual, Chapter 3- Verifying Potential Errors and Taking Corrective Actions, §3.3, Policies and Guidelines Applied During Review
14. Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110, Durable Medical Equipment – General
15. Medicare National Coverage Determinations Manual, Chapter 1, §40.2, Home Blood Glucose Monitors
16. CGS and Noridian Healthcare Solutions LCD L33822- Glucose Monitors, Effective 10/01/2015; Revised 1/01/2019
17. CGS  and Noridian LCA A52464- Glucose Monitor, Effective 10/012015; Revised: 01/01/19
18. CGS  and Noridian Local Coverage Article: Standard Documentation Requirements for All Claims Submitted to DME MACs A55426 – Effective 01/01/2017; Revised 01/01/2020