Description
This review will determine if the submitted documentation supports Medicare’s coverage criteria and reasonable and necessary requirements for nebulized drugs.
Affected Code(s)
J2545, J7605, J7606, J7608, J7611, J7612, J7613, J7614, J7620, J7626, J7631, J7639, J7644, J7669, J7677, J7682, J7686, Q0474, K0730, E0574, Q0513, Q0514
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 National Coverage Determinations Manual, Chapter 1, Part 4, §200.2- Nebulized Beta-Adrenergic Agonist Therapy for Lung Diseases
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, §4.26- Supplier Proof of Delivery Documentation Requirements (*Historical, for claims with Dates of Service Prior to 10/12/2021)
20. Medicare Program Integrity Manual, Ch. 4- Program Integrity, §4.7.3.1- Supplier Proof of Delivery Documentation Requirements
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, 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)
23. 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 01/01/2024
24. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Determination L33370: Nebulizers; Effective 10/01/2015; Revised 01/01/2024
25. CGS Administrators, LLC, and Noridian Healthcare Solutions, LLC, Local Coverage Article A52466: Nebulizers- Policy Article; Effective 10/01/2015; Revised 01/01/2024
26. HCPCS level II Codebook