0208-Enteral Nutrition Therapy with Dates of Service on/after September 5 2021: Medical Necessity and Documentation Requirements

Dynamic List Information
Dynamic List Data
Issue Name
0208-Enteral Nutrition Therapy with Dates of Service on/after September 5 2021: Medical Necessity and Documentation Requirements
Review Type
Complex
Provider Type
DME Physician/DME Supplier
MAC Jurisdiction
All DME MACs
Date
2021-12-07
RAC Type
Approved

Description

Enteral nutrition is considered reasonable and necessary for a patient with a functioning gastrointestinal tract who, due to pathology to, or non-function of, the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength commensurate with his or her general condition. Documentation will be reviewed to determine if claims for enteral nutrition, with dates of service on or after September 5, 2021, meet coverage criteria and/or are medically reasonable and necessary. 

Affected Codes

B4034, B4035, B4036, B4081, B4082, B4083, B4087, B4088, B4149, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, B4162, B9002

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 Benefit Policy Manual, Ch. 15- Covered Medical and Other Health Services, §110.2(C)- Repairs, Maintenance, Replacement, and Delivery; §120- Prosthetic Devices
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- 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; §5.2.3- Detailed 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.    Medicare National Coverage Determination Manual, NCD Section 180.2- Enteral and Parenteral Nutrition Therapy (*Historical, for claims with Dates of Service Prior to 01/01/2022)
23.    Medicare National Coverage Determination Manual, NCD Section 180.2- Enteral and Parenteral Nutrition Therapy; Revised 01/01/2022; Retired 4/10/2023- Effective January 1, 2022, the Centers for Medicare & Medicaid Services determined that no national coverage determination (NCD) is appropriate at this time for Enteral and Parenteral Nutritional Therapy. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the Social Security Act.
24.    CGS Administrators, LLC and Noridian Healthcare Solutions, LLC, LCD L38955- Enteral Nutrition, Effective 9/5/2021; Revised 7/02/2023
25.    CGS Administrators, LLC and Noridian Healthcare Solutions, LLC, Local Coverage Article A58833- Enteral Nutrition- Policy Article, Effective 9/5/2021; Revised 7/02/2023
26.    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)
27.    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 01/01/2023