Description
Claims for Custom Fabricated Knee Orthoses that do not meet indications of coverage and/or medical necessity outlined in the references listed above will be denied
Affected Code(s)
L1844, L1846
L2385, L2390, L2395, L2397, L2405, L2415, L2492, L2755, L2785, L2795, L2800
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: 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 Benefit Policy Manual, Ch. 15- Covered Medical and Other Health Services, §110.2(C)- Repairs, Maintenance, Replacement, and Delivery
15. 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
16. 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
17. 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
18. Medicare Program Integrity Manual, Ch. 4- Program Integrity, §4.26- Supplier Proof of Delivery Documentation Requirements (*Historical, for claims with Dates of Service prior to 10/12/2021)
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- 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
21. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME, §5.17- Definition of Customized DMEPOS
22. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Determination L33318: Knee Orthoses; Effective 10/01/2015; Revised 1/01/2020
23. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A52465: Knee Orthoses - Policy Article; Effective 10/1/2015, Revised 07/20/2023
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 4/6/2020 (*Historical, for claims with Dates of Service prior to 01/01/2023)
25. 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
26. HCPCS Level II Codebook