Description
Documentation will be reviewed to determine if a blood glucose monitor with integrated voice synthesizer meets Medicare coverage criteria, meets applicable coding guidelines, and/or is medically reasonable and necessary.
Affected Code(s)
E2100
Applicable Policy References
1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, §1833(e) - Payment of Benefits
2. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, §1834(a)(7)(C)(i), (ii) and (iii)- Replacement of Items; §1834(m)- Payment for Telehealth Services
3. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, §1842(p)(4)- Provisions Relating to the Administration of Part B
4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, §1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer
5. 42 CFR §405.929- Post-Payment Review
6. 42 CFR §405.930- Failure to Respond to Additional Documentation Request
7. 42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Initiated by a Contractor; and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party
8. 42 CFR §405.986- Good Cause for Reopening
9. 42 CFR §410.38- Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS): Scope and Conditions
10. 42 CFR §410.78- Telehealth Services
11. 42 CFR, §414.210(f)- Payment for Replacement of Equipment
12. 42 CFR §414.234(b)- Master List of Items Potentially Subject to Face-To-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements.
13. 42 CFR §414.65- Payment for Telehealth Services
14. Medicare National Coverage Determinations Manual, Chapter 1, §40.2, Home Blood Glucose Monitors
15. Medicare Benefit Policy Manual, Ch. 15- Covered Medical and Other Health Services, §110.2(C)- Repairs, Maintenance, Replacement, and Delivery
16. Medicare Benefit Policy Manual, Ch. 16- General Exclusions from Coverage, §180- Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare
17. Medicare Claims Processing Manual, Ch. 20- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), §50- Payment for Replacement of Equipment; §110- General Billing Requirements - for DME, Prosthetics, Orthotic Devices, and Supplies
18. Medicare Program Integrity Manual, Ch. 3- Verifying Potential Errors and Taking Corrective Actions, §3.2.3.8- No Response or Insufficient Response to Additional Documentation Requests, §3.3.1.1(B)- Medical Record Review; §3.3.2.1- Documents on Which to Base a Determination; §3.3.2.1.1- Progress Notes and templates; §3.3.2.1.2- DMEPOS Orders; §3.3.2.2- Absolute Words and Prerequisite Therapies; §3.3.2.4- Signature Requirements; §3.3.2.5- Amendments, Corrections and Delayed Entries in Medical Documentation §3.5- Postpayment Medical Record Review of Claims; §3.6.2.1- Coverage Determinations; §3.6.2.2- Reasonable and Necessary Criteria; and §3.6.2.4- Coding Determinations
19. Medicare Program Integrity Manual, Ch. 4- Program Integrity, §4.7.3.1- Supplier Proof of Delivery Documentation Requirements
20. Medicare Program Integrity Manual, Ch. 5- Items and Services Having Special DME Review Considerations, §5.1- Home Use of DME, Prosthetics, Orthotics, and Supplies (DMEPOS);§5.2- Rules Concerning Orders; §5.2.1- Physician Orders; §5.2.2- Verbal and Preliminary Written Orders; §5.2.4- Written Orders Prior to Delivery; §5.2.5- Face-to-Face Encounter Requirements; §5.2.5.1- Face-to-Face Encounter Conducted by the Physician; §5.2.5.2- Face-to-Face Encounter Conducted by a Nurse Practitioner, Physician Assistant or Clinical Nurse Specialist; §5.2.6- Date and Timing Requirements; §5.2.7- Requirement of New Orders; §5.2.8- Refills of DMEPOS Items Provided on a Recurring Basis; §5.3- Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs); §5.5- Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs; §5.6- Physician Assistant Rules Concerning Orders and CMNs; §5.7- Documentation in the Patient's Medical Record; §5.8- Supplier Documentation; §5.9 Evidence of Medical Necessity; (*Historical, for claims with Dates of Service prior to 01/01/2020)
21. Medicare Program Integrity Manual, Ch. 5- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Services Having Special DME Review Considerations, §5.1-Home Use of DME, Prosthetics, Orthotics, and Supplies; §5.2- Rules Concerning DMEPOS Orders/Prescriptions; §5.2.1- Standard Written Order/ Prescription (SWO); §5.2.2- Required Elements of a SWO; §5.2.3- Who can complete a SWO; §5.2.4- Timing of the Order/Prescription; §5.2.5- When a New Order/Prescription is Required; §5.2.6- Refills of DMEPOS Items Provided on a Recurring Basis; §5.3- Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and WOPD and/or Prior Authorization Requirements; §5.4- Face-to-Face Encounter Definition; §5.4.1- Timing of the Face-to-Face Encounter; §5.4.2- Documentation from the Face-to-Face Encounter; §5.5- Certificates of Medical Necessity (CMNs) and DME Information Forms (DIFs); §5.7- Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs; §5.8- Physician Assistant Rules Concerning Orders and CMNs; §5.9- Documentation in the Patient’s Medical Record; §5.10- Supplier Documentation; and §5.11- Evidence of Medical Necessity
22. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC LCD L33822- Glucose Monitors; Effective 10/01/2015; Revised 04/01/2024
23. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC LCA A52464- Glucose Monitor- Policy Article; Effective 10/01/2015; Revised 04/01/2024
24. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A55426: Standard Documentation Requirements for All Claims Submitted to DME MACs; Effective 01/01/2017; Revised 01/01/2024