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CMS Approved Audit Issues

This list includes all CMS-approved audit issues.

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Details
HCPCS A4253: Blood Glucose Test or Reagent Strips
_0152
Complex
DME by Supplier/DME Physician
Region-5
5 - Nationwide
06/14/2019

HCPCS A4253: Blood Glucose Test or Reagent Strips

Issue Name: HCPCS A4253: Blood Glucose Test or Reagent Strips
Issue Number: _0152
Review Type Complex
Provider Type: DME by Supplier/DME Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 06/14/2019
Date Revised:
Dates Service: Claims that have a ‘claim paid date’ which is less than 3 years prior to the Additional Documentation Request.
Description: "The quantity of glucose test strips (A4353) that are covered depends upon the usual medical needs of the diabetic patient. Documentation will be reviewed to determine if the utilization guidelines for blood glucose test strips (A4253) were met. "
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 - Special Payment Rules 4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(j) - Requirements for Suppliers of Medical Equipment and Supplies 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 1861(s) - Medical and Other Health Services Definitions 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 §424.57- Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges 10. 42 CFR §424.57(c)- Application Certification Standards 11. 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 12. Medicare Program Integrity Manual, Chapter 4- Program Integrity, §4.26 Supplier Proof of Delivery Documentation Requirements Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110- Durable Medical Equipment- General 13. Medicare Program Integrity Manual, Chapter 5, Section 5.2 - Rules Concerning Orders, Physician Orders 14. Medicare Program Integrity Manual, Chapter 5, Section 5.2.1- Rules Concerning Orders, Physician Orders 15. Medicare Program Integrity Manual, Chapter 5, Section 5.2.2 – Verbal and Preliminary Written Orders 16. Medicare Program Integrity Manual, Chapter 5, Section 5.2.3- Rules Concerning Orders, Detailed Written Orders 17. Medicare Program Integrity Manual, Chapter 5, Section 5.2.7 - Requirements of New Orders 18. Medicare Program Integrity Manual, Chapter 5, Section 5.2.8 - Refills of DMEPOS Items Provided on a Recurring Basis 19. Medicare Program Integrity Manual, Chapter 5, Section 5.7- Documentation in the Patient’s Medical Record 20. Medicare Program Integrity Manual, Chapter 5, Section 5.8- Supplier Documentation 21. Medicare Program Integrity Manual, Chapter 5, Section 5.9- Evidence of Medical Necessity 22. CMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1 Coverage Determinations, Section 40.2 Home Blood Glucose Monitors 23. CMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1 Coverage Determinations, Section 190.20- Blood Glucose Testing 24. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Determination L33822-Glucose Monitors, Effective Date: 10/1/2015; Revised 01/12/2017 25. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A52464 Glucose Monitor - Policy Article, Effective Date: 10/01/2015; Revised: 06/07/2018 26. 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 08/28/2018"
Upper Limb Orthoses within the Reasonable Useful Lifetime (RUL)
_0155
Automated
DME by Supplier and DME by Physician
Region-5
5 - Nationwide
05/17/2019

Upper Limb Orthoses within the Reasonable Useful Lifetime (RUL)

Issue Name: Upper Limb Orthoses within the Reasonable Useful Lifetime (RUL)
Issue Number: _0155
Review Type Automated
Provider Type: DME by Supplier and DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 05/17/2019
Date Revised:
Dates Service: Claims that have a “paid claim date” which is less than 3 years prior to the Informational Letter date (automated review)
Description: Claims for upper limb orthoses with dates of service within 5 years of the date of service of a previously paid upper limb orthoses for the same beneficiary, for HCPCS codes identified as same, for the same anatomical site, will be denied as the reasonable useful lifetime requirement has not been met. Affected codes: L3650, L3660, L3670, L3671, L3674, L3675, L3677, L3678, L3702, L3710, L3720, L3730, L3740, L3760, L3761, L3762, L3763, L3764, L3765, L3766, L3806, L3807, L3808, L3809, L3900, L3901, L3904, L3905, L3906, L3908, L3912, L3913, L3915, L3916, L3917, L3918, L3919, L3921, L3923, L3924, L3929, L3930, L3931, L3956, L3960, L3961, L3962, L3967, L3971, L3973, L3975, L3976, L3977, L3978, L3980, L3981, L3982, L3984 and L3995
References: "1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e) - Payment of Benefits 2. Social Security Act, Section 1834 (a) [42 U.S.C. 1395m], Payment for Durable Medical Equipment. 3. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(a)(7)(C)(i),(ii) and (iii)- Payment for Other Items of Durable Medical Equipment 4. 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 5. 42 CFR §405.986- Good Cause for Reopening 6. 42 CFR §414.210- General Payment Rules 7. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 110.2.C 8. 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 08/28/2018"
Therapeutic Shoes and Inserts for Persons with Diabetes
_0141
Complex
DME by Supplier/ DME by Physician
Region-5
5 - Nationwide
04/26/2019

Therapeutic Shoes and Inserts for Persons with Diabetes

Issue Name: Therapeutic Shoes and Inserts for Persons with Diabetes
Issue Number: _0141
Review Type Complex
Provider Type: DME by Supplier/ DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 04/26/2019
Date Revised:
Dates Service: Claims having a “claim paid date” less than 3 years prior to the ADR date will be included.
Description: This review will determine if the documentation submitted for review meets Medicare’s coverage requirements for Diabetic Shoes and Inserts. Claims where the documentation submitted does not support the coverage requirements will be denied. Affected codes A5500, A5501, A5512, A5513
References: "1. SSA 1861(s)(12)- Definitions of Services, Institutions, Etc.; Medical and Other Health Services 2. SSA 1861(qq)(1)- Definitions of Services, Institutions, Etc.; Diabetes Outpatient Self-Management Training Services 3. SSA 1833(o)- Payment Of Benefits 4. Medicare Benefit Policy Manual, Chapter 15, §140, Therapeutic Shoes for Individuals with Diabetes 5. Medicare Program Integrity Manual, Chapter 4, §4.26, Supplier Proof of Delivery Documentation Requirements 6. Medicare Program Integrity Manual, Chapter 5, Section 5.2- Rules Concerning Orders 7. Medicare Program Integrity Manual, Chapter 5, Section 5.7- Documentation in the Patient's Medical Record 8. Medicare Program Integrity Manual, Chapter 5, Section 5.8- Supplier Documentation 9. Medicare Program Integrity Manual, Chapter 5, Section 5.9- Evidence of Medical Necessity 10. Local Coverage Determination L33369: Therapeutic Shoes for Persons with Diabetes -Effective Date 10/1/2015 Revision 10/01/2015, Revision 07/01/2016; Revision 01/01/2017 and Revision 04/01/2018. 11. Local Coverage Article A52501: Therapeutic Shoes for Persons with Diabetes - Effective Date 10/1/2015, Revision 10/01/2015, Revision 07/01/2016; Revision 10/01/2016, Revision 01/01/2017 and Revision 04/01/2018. 12. CMS Policy Article A55426: Standard Documentation Requirements for All Claims Submitted to DME MACs - Effective Date 01/01/2017, Revision 04/20/2017, Revision 05/25/2017, Revision 06/01/2017, Revision 11/20/2017, 12/21/2017, 05/07/2018 and 08/28/18. "
Knee Orthoses within the Reasonable Useful Lifetime (RUL)
_0148
Automated
DME by Supplier and DME by Physician
Region-5
5 - Nationwide
05/01/2019

Knee Orthoses within the Reasonable Useful Lifetime (RUL)

Issue Name: Knee Orthoses within the Reasonable Useful Lifetime (RUL)
Issue Number: _0148
Review Type Automated
Provider Type: DME by Supplier and DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 05/01/2019
Date Revised:
Dates Service: Claims that have a “paid claim date” which is less than 3 years prior to the Informational Letter date (automated review)
Description: Claims for knee orthoses with dates of service within the period of reasonable useful lifetime (RUL) of a previously paid knee orthoses for the same beneficiary, for the same anatomical site, will be denied as the reasonable useful lifetime (RUL) requirement has not been met. Affected codes: L1810, L1812, L1820, L1830, L1831, L1832, L1833, L1834, L1836, L1840, L1843, L1844, L1845, L1846, L1850, L1851, L1852, L1860
References: "1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e) - Payment of Benefits 2. Social Security Act, Section 1834 (a) [42 U.S.C. 1395m], Payment for Durable Medical Equipment. 3. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(a)(7)(C)(i),(ii) and (iii)- Payment for Other Items of Durable Medical Equipment 4. 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 5. 42 CFR §405.986- Good Cause for Reopening 6. 42 CFR §414.210- General Payment Rules 7. CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 110.2.C 8. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC- LCD L33318, Knee Orthoses, Effective Date 10/01/2015; Revision Effective Date 10/16/2017 9. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC- Local Coverage Article A52465 Knee Orthoses, Effective Date 10/01/2015; Revision Effective Date 01/01/2017 10. 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 08/28/2018"
Off-the-Shelf Knee Orthosis
_0144
Complex
DME by Supplier/ DME by Physician
Region-5
5 - Nationwide
03/15/2019

Off-the-Shelf Knee Orthosis

Issue Name: Off-the-Shelf Knee Orthosis
Issue Number: _0144
Review Type Complex
Provider Type: DME by Supplier/ DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 03/15/2019
Date Revised:
Dates Service: Less than 3 years and on or after October 1, 2015
Description: Off-the-Shelf Knee Orthoses may have been provided to beneficiaries where all Medicare coverage requirements were not met. This review will determine if the orthoses is reasonable and necessary for the patient’s condition based on the documentation in the medical record. Claims that do not meet the indications of coverage and/or medical necessity requirements will be denied. Affected codes: L1812, L1820, L1830, L1831, L1833, L1836, L1848, L1850, L1851 and L1852
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 - Special Payment Rules 4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(j) - Requirements for Suppliers of Medical Equipment and Supplies 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 1861(s) - Medical and Other Health Services Definitions 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 §424.57- Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges 10. 42 CFR §424.57(c)- Application Certification Standards 11. 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 12. Medicare Program Integrity Manual, Chapter 4- Program Integrity, §4.26 Supplier Proof of Delivery Documentation Requirements 13. Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110- Durable Medical Equipment- General 14. Medicare Program Integrity Manual, Chapter 5, Section 5.2 - Rules Concerning Orders, Physician Orders 15. Medicare Program Integrity Manual, Chapter 5, Section 5.2.1- Rules Concerning Orders, Physician Orders 16. Medicare Program Integrity Manual, Chapter 5, Section 5.2.2 – Verbal and Preliminary Written Orders 17. Medicare Program Integrity Manual, Chapter 5, Section 5.2.3- Rules Concerning Orders, Detailed Written Orders 18. Medicare Program Integrity Manual, Chapter 5, Section 5.2.7 - Requirements of New Orders 19. Medicare Program Integrity Manual, Chapter 5, Section 5.2.8 - Refills of DMEPOS Items Provided on a Recurring Basis 20. Medicare Program Integrity Manual, Chapter 5, Section 5.7- Documentation in the Patient’s Medical Record 21. Medicare Program Integrity Manual, Chapter 5, Section 5.8- Supplier Documentation 22. Medicare Program Integrity Manual, Chapter 5, Section 5.9- Evidence of Medical Necessity 23. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC Local Coverage Determination (LCD) L33318, Knee Orthoses; Effective Date: 10/01/2015; Revision Effective Date 10/16/2017 24. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC Local Coverage Article A52456, Knee Orthoses; Effective Date: 10/01/2015; Revision Effective Date: 01/01/2017 25. 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 08/28/2018"
Issue Name Pneumatic Compression Device
_0131
Complex
DME Supplier and DME by Physician
Region-5
5 - Nationwide
01/23/2019

Issue Name Pneumatic Compression Device

Issue Name: Issue Name Pneumatic Compression Device
Issue Number: _0131
Review Type Complex
Provider Type: DME Supplier and DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 01/23/2019
Date Revised:
Dates Service: Exclude from review claims having a “claim paid date” which is more than 3 years prior to the ADR date and prior to 12/01/2015
Description: Pneumatic Compression Devices, HCPCS Codes E0651 and E0652, may have been provided to patients where all Medicare coverage criteria were not met. This review will determine if the pneumatic compression device is reasonable and necessary for the patient’s condition based on the documentation in the medical record. Claims that do not meet the indications of coverage and/or medical necessity will be denied. Affected code E0651 and E0652
References: Title XVIII, Social Security, §1833(e) ; Title XVIII of the Social Security Act (SSA): Section 1862(a)(1)(A); Code of Federal Regulations, 42 CFR sections 405.980 (b) & (c) and section 405.986; Code of Federal Regulations, 42 CFR; section 410.38(g)(3); Code of Federal Regulations, 42 CFR; section 410.38(g)(4); Code of Federal Regulations, 42 CFR; section 424.57 (12); Medicare Benefit Policy Manual, Chapter 15, Section 110, Durable Medical Equipment – General; Medicare National Coverage Determination (NCD) Manual, (IOM) Publication 100-03, Chapter 1, Part 4, Section 280.6, Pneumatic Compression Devices; Medicare Claims Processing Manual, (IOM) Publication 100-04, Chapter 30 Section 50.13.4, Supplier’s Right to Recovery Resalable Items for Which Refund Has Been Made; Medicare Program Integrity Manual, (IOM) Publication 100-8, Chapter 4, Section 4.26, Supplier Proof of Delivery Documentation Requirements; Medicare Program Integrity Manual, (IOM) Publication 100-8, Chapter 5, Section 5.2.4 – 5.2.8, 5.7, 5.8, and 5.9; Local Coverage Determination (LCD) L33829 – Pneumatic Compression Devices; Effective 10/01/2015; Revised 01/01/2017; MAC Policy Article A52488 – Pneumatic Compression Devices; Effective 10/01/2015; Revised 01/01/2017; CMS Policy Article for Standard Documentation Requirements for All Claims Submitted to DME MACs (A55426), Effective 1/1/2017; Revised 05/07/2018
Spinal Orthosis (TLSO/ LSO) within the Reasonable Useful Lifetime (RUL)
_0128
Automated
DME by Supplier and DME by Physician
Region-5
5 - Nationwide
01/01/2019

Spinal Orthosis (TLSO/ LSO) within the Reasonable Useful Lifetime (RUL)

Issue Name: Spinal Orthosis (TLSO/ LSO) within the Reasonable Useful Lifetime (RUL)
Issue Number: _0128
Review Type Automated
Provider Type: DME by Supplier and DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 01/01/2019
Date Revised:
Dates Service: Claims that have a “claim paid date” which is less than 3 years prior to the informational Letter date (automated review)
Description: Claims for more than one spinal orthosis within the reasonable useful lifetime (Spinal Orthosis within the Reasonable Useful Lifetime [RUL]), will be denied. Affected codes: L0627, L0631, L0637, L0642, L0648, L0650
References: 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; Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e) - Payment of Benefits; Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834 - Special Payment Rules; Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(j) - Requirements for Suppliers of Medical Equipment and Supplies; 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; Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1861(s) - Medical and Other Health Services Definitions; 42 CFR §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, Decisions, and Reviews, (b)- Timeframes and Requirements for Reopening Initial Determinations and edeterminations Initiated by a Contractor;  and (c)- Timeframes and Requirements for Reopening Initial Determinations and Redeterminations Requested by a Party; 42 CFR §405.986- Good Cause for Reopening; 42 CFR §414.210- General Payment Rules; 42 CFR §424.57- Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges; 42 CFR §424.57(c)- Application Certification Standards; Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110- Durable Medical Equipment- General; 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; Medicare Program Integrity Manual, Chapter 4- Program Integrity, §4.26 Supplier Proof of Delivery Documentation Requirements ; Medicare Program Integrity Manual, Chapter 5, Section 5.2 - Rules Concerning Orders, Physician Orders; Medicare Program Integrity Manual, Chapter 5, Section 5.2.7 - Requirements of New Orders; Medicare Program Integrity Manual, Chapter 5, Section 5.2.8 - Refills of DMEPOS Items Provided on a Recurring Basis; Medicare Program Integrity Manual, Chapter 5, Section 5.7- Documentation in the Patient’s Medical Record; Medicare Program Integrity Manual, Chapter 5, Section 5.8- Supplier Documentation; Medicare Program Integrity Manual, Chapter 5, Section 5.9- Evidence of Medical Necessity; 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 08/28/2018
Durable Medical Equipment Billed during Hospice Period
_0114
Automated
DME Supplier/DME by Physician
Region-5
5 - Nationwide
09/20/2018

Durable Medical Equipment Billed during Hospice Period

Issue Name: Durable Medical Equipment Billed during Hospice Period
Issue Number: _0114
Review Type Automated
Provider Type: DME Supplier/DME by Physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 09/20/2018
Date Revised:
Dates Service: Claims that have a “claim paid date” which is less than 3 years prior to the informational letter date (automated review).
Description: All DME billed after the admit date of a patient to Hospice services and before the discharge date of a patient from Hospice services or any claims billed after the admit date of a patient to Hospice services and null discharge date (when patient status code is 30), will be denied as inclusive to Hospice services if after comparing principal diagnoses, the DME claim is related to the Hospice diagnosis. This review also excludes claims with the GW modifier. Affected codes: See Appendix D.
References: "1. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1833(e) - Payment of Benefits 2. Social Security Act (SSA), Title XVIII, §1861(dd)(1) of the Social Security Act- Hospice Care; Hospice Program 3. 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 4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1861(s) - Medical and Other Health Services Definitions 5. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(j) - Requirements for Suppliers of Medical Equipment and Supplies 6. 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 7. 42 Code of Federal Regulations (CFR) §405.980- Reopening of Initial Determinations, Redeterminations, Reconsiderations, and Reviews 8. 42 Code of Federal Regulations (CFR) §405.986- Good Cause for Reopening 9. Code of Federal Regulations 42, Section 418.202 (f), Hospice Care, Covered Services, Medical Appliances and Supplies, Including Drugs and Biologicals 10. 42 CFR §424.57- Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges 11. 42 CFR §424.57(c)- Application Certification Standards 12. Medicare Benefit Policy Manual, Chapter 9- Coverage of Hospice Services Under Hospital Insurance, Section 10- Requirements- General 13. Medicare Claims Processing Manual, Chapter 11- Processing Hospice Claims, Section 10- Overview, Section 30.3- Data Required on the Institutional Claim to A/B MAC (HHH), Section 40.2- Processing Professional Claims for Hospice Beneficiaries 14. Medicare Claims Processing Manual- Chapter 20- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), Section 10.2- Coverage Tables for DME Claims"
Custom Fabricated Knee Orthosis: Medical Necessity
_0107
Complex
DME by supplier; DME by physician
Region-5
5 - Nationwide
09/14/2018

Custom Fabricated Knee Orthosis: Medical Necessity

Issue Name: Custom Fabricated Knee Orthosis: Medical Necessity
Issue Number: _0107
Review Type Complex
Provider Type: DME by supplier; DME by physician
Region: Region-5
State: 5 - Nationwide
Date Approved: 09/14/2018
Date Revised:
Dates Service: Less than 3 years
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 codes L1844 - KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED; L1846 - KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED
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 - Special Payment Rules 4. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(a)(4) - Payment for Certain Customized Items 5. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(a)(6) - Payment for Other Items of Durable Medical Equipment 6. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h) - Payment for Prosthetic Devices and Orthotics and Prosthetics 7. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h)(1) - General Rule for Payment 8. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h)(1)(F) - Special Payment Rules for Certain Prosthetics and Custom Fabricated Orthotics 9. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h)(1)(F)(ii) - Description of custom-fabricated item. 10. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(h)(1)(F)(iii) - Qualified practitioner defined 11. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1834(j) - Requirements for Suppliers of Medical Equipment and Supplies 12. 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 13. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1861(n) - Durable Medical Equipment Definition 14. Social Security Act (SSA), Title XVIII- Health Insurance for the Aged and Disabled, Section 1861(s) - Medical and Other Health Services Definitions 15. 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 16. 42 CFR §405.986 - Good Cause for Reopening 17. 42 CFR §424.57 - Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges 18. 42 CFR §424.57(c) - Application Certification Standards 19. Medicare Benefit Policy Manual, Chapter 15- Covered Medical and Other Health Services, §110- Durable Medical Equipment- General 20. Medicare Program Integrity Manual, Chapter 3 - Verifying Potential Errors and Taking Corrective Actions, §3.3.2.4- Signature Requirements 21. 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 22. Medicare Program Integrity Manual, Chapter 5, Section 5.2 - Rules Concerning Orders, Physician Orders 23. Medicare Program Integrity Manual, Chapter 5, Section 5.2.1- Rules Concerning Orders, Physician Orders 24. Medicare Program Integrity Manual, Chapter 5, Section 5.2.2 – Verbal and Preliminary Written Orders 25. Medicare Program Integrity Manual, Chapter 5, Section 5.2.3- Rules Concerning Orders, Detailed Written Orders 26. Medicare Program Integrity Manual, Chapter 5, Section 5.2.7 - Requirements of New Orders 27. Medicare Program Integrity Manual, Chapter 5, Section 5.7- Documentation in the Patient’s Medical Record 28. Medicare Program Integrity Manual, Chapter 5, Section 5.8- Supplier Documentation 29. Medicare Program Integrity Manual, Chapter 5, Section 5.9- Evidence of Medical Necessity 30. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Determination L33318: Knee Orthoses: Effective Respiratory Assist Device, Effective 10/01/2015; Revised 1/01/2019 31. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC , Local Coverage Article: Knee Orthoses - Policy Article A52465: Effective 10/1/2015, Revision 01/01/2019 32. 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 01/01/2019"