0013 - Ankle-Foot Orthoses and Knee-Ankle-Foot Orthoses: Medical Necessity and Documentation Requirements

Issue Name
0013 - Ankle-Foot Orthoses and Knee-Ankle-Foot Orthoses: Medical Necessity and Documentation Requirements
Date
Review Type
Complex
Provider Type
DME Physician/DME Supplier
MAC Jurisdiction
All DME MACs

Description

Ankle-Foot Orthosis and Knee-Ankle-Foot Orthosis must meet basic coverage criteria at initial purchase as outlined in CMS Publications and Local Coverage Determination (LCDs) for AFO/KAFO Orthoses. Medical documentation will be reviewed to determine that services were reasonable and necessary

Affected Code(s)

L1900, L1904, L1907, L1920, L1940, L1945, L1950, L1960, L1970, L1980, L1990, L2106, L2108, L4631, L2000, L2005, L2010, L2020, L2030, L2034, L2036, L2037, L2038, L2126, L2128

Applicable Policy References 

1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1862(a)(1)(A)- Exclusions from Coverage and Medicare as a Secondary Payer
2. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e)- Payment of Benefits
3. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(a)- Payment for Durable Medical Equipment, (1)(E)(i)(ii)- Clinical Conditions for Coverage; (4)- Payment for Certain Customized Items; (7)(C)(i), (ii) and (iii)- Payment for Other Items of Durable Medical Equipment
4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h) (1) (F) (i) (ii)- Payment for Prosthetic Devices and Orthotics and Prosthetics
5. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1842(p)(4)- Provisions Relating to the Administration of Part B
6. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1847(a)(2)- Competitive Acquisition of Certain Items
7. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1861(s)(9)- Medical and Other Health Services
8. 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
9. 42 CFR §405.986- Good Cause for Reopening 
10. 42 CFR §410.38- Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS): Scope and Conditions
11. 42 CFR §414.210(f)- Payment for replacement of equipment
12. 42 CFR §414.402- Definitions
13. 42 CFR §424.57- Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges, (c)- Application Certification Standards, (12) 
14. Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110- Durable Medical Equipment- General
15. Medicare Claims Processing Manual, Chapter 20- Durable Medical Equipment, Prosthetics, Orthotics and Supplies, Section 100.2- General Documentation Requirements- Certificates of Medical Necessity
16. Medicare 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
17. Medicare Program Integrity Manual, Chapter 4- Program Integrity, §4.26- Supplier Proof of Delivery Documentation Requirements
18. Medicare Program Integrity Manual, Chapter 5- Items and Services Having Special DME Review Considerations, §5.2.1- Physician Orders, §5.2.3- Detailed Written Orders, §5.2.4- Written Orders Prior to Delivery, §5.2.5- Face to Face Encounter Requirements, §5.2.6- Date and Timing Requirements, §5.2.7- Requirement of New Order, §5.2.8- Refills of DMEPOS Items Supplied on a Recurring Basis, §5.7- Documentation in the Patient’s Medical Record, §5.8- Supplier Documentation, and §5.9- Evidence of Medical Necessity.
19. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Determination L33686- Ankle-Foot/ Knee-Ankle-Foot Orthosis, Effective 10/01/2015; Revised 1/01/2020
20. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Policy Article A52457- Ankle-Foot/ Knee-Ankle-Foot Orthoses, Effective 10/01/2015; Revised 1/01/2019
21. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article: Standard Documentation Requirements for All Claims Submitted to DME MACs A55426 – Effective 01/01/2017; Revised 01/01/2020