CurrentAlliance HealthPolicy Clinical Coverage Policy No: 5A-3

Nursing Equipment and Supplies (Durable Medical Equipment and Supplies)

State Medicaid clinical coverage policy describing coverage, exclusions, prior approval, documentation, and provider requirements for durable medical equipment (DME), nursing equipment and supplies, including specific sections for NPWT, external insulin infusion pumps, blood glucose monitors, and general DME rules.

Policy Summary

PayerAlliance Health

PolicyNursing Equipment and Supplies (Durable Medical Equipment and Supplies)

Policy CodePolicy Clinical Coverage Policy No: 5A-3

Change TypeHCPCS/coverage updates

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionProviders must obtain prior approval for items identified on the Durable Medical Equipment Fee Schedule using the CMN/PA form and submit requests and supporting health records to the DHHS Utilization Review Contractor.

POLICY UPDATE CHANGES

Numerous HCPCS code additions, deletions, replacements, and description updates across multiple revision dates (2003-2022) as detailed in the revision history

Removed prior authorization requirement for certain items (e.g., E0202 phototherapy light) and removed PA for some BGMs and CGM changes

Providers must submit PA requests for unlisted items through NCTracks (10/01/2019)

Added ICD-10 codes E10A0, E10A1, E10A2 to blood glucose monitors and related supplies effective 10/01/2024 (03/01/2025 revision).

Removed HCPCS codes A9276, A9277, A9278 and end dated coverage 01/31/2025 as replaced by A4238 and E2102 (03/01/2025 revision).

Coverage and quantity limits added for HCPCS codes A4271 and E2104 effective 04/01/2024 (03/01/2025 revision).

Added medical necessity criteria for replacement blood pressure cuffs (01/15/2024).

Removed prior authorization requirement for HCPCS code E0202 and updated maximum rental days from 30 to 31 (effective 11/01/2021; noted 05/15/2022 revision).

6 monthsInitial NPWT prior approval max duration

monthlyNPWT re-approval frequency

>=4/daySMBG frequency for pump candidates

30Reclamation days allowed

2003-2022Revision history span (years)

2025-05-01Last amended date

Coverage Summary

This policy covers Nursing Equipment and Supplies (Durable Medical Equipment and Supplies). It defines DME and supplies and describes covered categories including Inexpensive or Routinely Purchased, Capped Rental or Purchased Equipment, Equipment Requiring Frequent and Substantial Servicing, Related Supplies, Service and Repair, and Individually Priced Items (see Attachment A, Section C for HCPCS and fee schedule references). Prior approval for listed items is managed through NCTracks and items that require prior approval are identified on the Durable Medical Equipment Fee Schedule. For beneficiaries under age 21, EPSDT provisions apply (EPSDT exception to policy limitations) and EPSDT requests should be submitted as an EPSDT review via NCTracks. Key documentation thresholds include a face-to-face encounter within 6 months prior to initiation and clinician review of ongoing need at least annually.

Key thresholds

Face-to-face recencyDocumented face-to-face encounter within 6 months prior to initiation

NPWT initial durationInitial prior approval up to a maximum of 6 consecutive months

NPWT reapproval frequencyRe-approvals for continued coverage granted monthly (maximum 1 month per reapproval) with monthly wound assessment

SMBG frequency for pump candidatesDocumented average self-monitoring of blood glucose >=4 times per day (2-month average for new pump pathway; 1-month for prior pump owners)

WCD initial periodWCD is rental only; initial prior approval given for 3 months

Farrell valve limitsInitial prior approval: maximum 1 valve per day per beneficiary for up to 6 months; successive 6-month approvals require re-establishing medical necessity

Bilirubin therapy age windowCovered for treatment of hyperbilirubinemia within first 31 calendar days of life; maximum of 7 consecutive days

Reclamation windowProvider(s) may reclaim rental equipment within 30 calendar days after termination

Medical Necessity Criteria (Grouped)

General Coverage Criteria

Covered when ALL of the following criteria are met:

ALL of the following

Beneficiary meets Medicaid eligibility and is enrolled in the plan.
Item is durable medical equipment or supply defined in policy and appropriate for use in home or outpatient setting.
Item is ordered by a licensed prescriber for use by the beneficiary and the order includes diagnosis, length of need, and frequency of use.
Clinical documentation in the medical record supports medical necessity and non-availability of less costly alternatives of equivalent clinical benefit.

Not Covered & Exclusions

General Non-Coverage Criteria

Medicaid shall not cover the procedure, product, or service related to this policy when:

General Non-Coverage Criteria: The beneficiary does not meet eligibility in Section 2.0; does not meet criteria in Section 3.0; the procedure/product/service duplicates another provider's; or is experimental/investigational/part of clinical trial.

Specific Non-Coverage by Medicaid

Medicaid shall not cover devices and supplies when any of the following apply:

Specific Non-Coverage by Medicaid: Items provided for beneficiary or caregiver convenience; backup or duplication at various locations; provided in any setting where payment could be made under Medicaid for inpatient services including room and board unless discharge plan to residential setting established; items covered by another agency; items for diagnoses related to hospice care per clinical coverage policy 3D.

Medicaid does not cover items when the beneficiary fails to meet policy eligibility or coverage criteria, for duplication, for items that are experimental or investigational, or for items provided for convenience or as backups. Items covered by another agency are not covered, and hospice-related exclusions apply per Clinical Coverage Policy 3D (Hospice Services). Experimental/investigational items, duplication of another provider's service, and items addressed under other policies or waivers are also excluded. Providers may use the unlisted-item review process (Attachment D) for items not listed on the fee schedule.

Coding (HCPCS / ICD / Modifiers) and Quantity Limits

HCPCS and local codes referenced historically/changed in revision historymixed

A4213	Insertion/maintenance supplies for enteral/parental feeding (historical reference)
A4217	Enteral feeding supply, syringe, single use (historical reference)
A4221	Enteral feeding supply, tubing, single use (historical reference)
A4222	Enteral feeding supply, adapter, single use (historical reference)
A4285	Enteral formula, oral, nutritionally complete, for special metabolic needs (historical reference)
A4286	Enteral formula, oral, nutritionally complete, for metabolic condition requiring energy dense formula (historical reference)
A4927	Enteral nutrition supply, enteral formula, modular component (historical reference)
A4930	Enteral nutrition supply, tube feeding formula, nutritionally complete (historical reference)
B4153	Amino acid-based infant formula, powder or liquid (historical reference)
B4154	Amino acid-based formula, for older infants/children (historical reference)

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HCPCS/CPT Codes with Lifetime Expectancy or Quantity LimitsHCPCS

A4213	Insertion/maintenance supplies for enteral/parental feeding
A4217	Enteral feeding supply, syringe, single use
A4221	Enteral feeding supply, tubing, single use
A4222	Enteral feeding supply, adapter, single use
A4285	Enteral formula, oral, nutritionally complete, for special metabolic needs — quantity/lifetime limits apply per Attachment A
A4286	Enteral formula, oral, nutritionally complete, energy-dense — quantity/lifetime limits apply per Attachment A
A4927	Modular enteral component — limits as specified in Attachment A
A4930	Enteral tube feeding formula, nutritionally complete — limits per Attachment A
B4153	Amino acid-based infant formula — quantity limits per Attachment A
B4154	Amino acid-based formula for older infants/children — limits per Attachment A

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Quantity-limited HCPCS/HCPCS-like supply codes and limitsHCPCSCovered

A4213	Insertion/maintenance supplies — quantity limits per 30-day or per-order as defined in Attachment A
A4217	Syringes for enteral feeding — quantity limits per beneficiary per month (see Attachment A)
A4221	Tubing sets — replacement frequency and quantity limits in Attachment A
A4222	Adapters — quantity limits per order in Attachment A
A4927	Modular formula components — quantity limited; prior authorization may be required
A4930	Tube feeding formula — quantity limits and coverage conditions specified in Attachment A
A4285	Oral enteral formula for special metabolic needs — quantity limits; PA required when exceeding standard supply
A4286	Energy-dense oral formula — quantity limits; see Attachment A for kcal/day thresholds
B4153	Amino acid-based infant formula — limited supply allowances; PA required for excess
B4154	Amino acid-based formula for older infants/children — quantity limits apply

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Miscellaneous / Attachment-specific codesmixedCovered

E0781	Enteral feeding pump — see Attachment B for pump models and rental/purchase rules
A4927	Modular enteral components — see Attachment A for definitive list and limits
A4930	Tube feeding formulas — Attachment A lists eligible products and limits

Procedure / HCPCS codes referencedHCPCS

E0781

Enteral feeding pump, infusion (procedure/hardware reference)

ICD-10 codes referencedICD-10

Z91.83	Patient's other specified feeding difficulty (example diagnosis referenced for enteral nutrition)
K90.0	Celiac disease (example comorbidity referenced)

Modifiers (including oral nutrition product modifiers)Modifier

GP	Services delivered under an outpatient physical therapy plan of care (example modifier)
JW	Amount of drug discarded/not administered (example)
RO	Right side (example)
Modifier for oral nutrition products	Use modifiers as specified in Attachment C for distinguishing enteral vs oral nutrition product billing

HCPCS/CPT Codes with Lifetime Expectancy or Quantity Limits (Definitive List in Attachment A)HCPCS

A4285	Enteral formula, oral, nutritionally complete, for special metabolic needs — see Attachment A for lifetime/quantity limits and PA requirements
A4286	Enteral formula, oral, nutritionally complete, energy-dense — limits and criteria in Attachment A
A4927	Modular enteral component — quantity limits in Attachment A
A4930	Enteral tube feeding formula, nutritionally complete — limits per Attachment A
B4153	Amino acid-based infant formula — quantity limits in Attachment A
B4154	Amino acid-based formula for older infants/children — limits in Attachment A
B4155	Amino acid-based formula, specialized — see Attachment A for limits
B4157	Amino acid-based elemental formula — limits in Attachment A
B4158	Amino acid-based formula, other specified — limits in Attachment A

Quantity-limited HCPCS/HCPCS-like supply codes and limits (Operational / Covered)HCPCSCovered

A4213	Insertion/maintenance supplies for enteral/parental feeding — quantity limits per Attachment A; PA required for excess
A4217	Enteral feeding syringe, single use — covered with quantity limits
A4221	Enteral feeding tubing — covered with replacement frequency limits
A4222	Adapters/connectors — covered with quantity limits
E0781	Enteral feeding pump — covered; see Attachment B for rental vs purchase and lifetime limits

Miscellaneous / Attachment-specific codesmixedCovered

A4927	Modular enteral components — definitive items listed in Attachment A
A4930	Tube feeding formulas — specific products and NDC/HCPCS crosswalk in Attachment A
E0781	Enteral feeding pump models and billing rules — see Attachment B

Procedure / HCPCS codes referenced (small group)HCPCS

E0781

Enteral feeding pump — referenced for service definitions

ICD-10 codes referenced (small group)ICD-10

E46	Protein-energy malnutrition (example ICD-10 referenced in nutrition section)
K90.1	Tropical sprue (example)

See Attachment A for the definitive fee schedule, the authoritative HCPCS lists and quantity/lifetime limits, and which items require prior authorization. Attachment B contains pump-specific models and rental/purchase rules. Attachment C describes modifier usage for oral nutrition products and billing nuances. The fee schedule and Attachment A contain official effective dates and specify which items require prior authorization.

Provider Actions — Prior Authorization, Documentation, Billing

Prior Authorization

Prior approval required for listed DME items

Prior approval is required for items identified on the Durable Medical Equipment Fee Schedule. Providers must obtain prior approval using the CMN/PA form and submit the prior approval request and all supporting health records to the DHHS Utilization Review Contractor.

Documentation Required

Disclose ownership/control and criminal convictions

Providers shall disclose ownership and control information, including any owners or employees convicted of criminal offenses against Medicare, Medicaid, and Title XX programs.

Background and Definitions

Background: The policy defines Durable Medical Equipment (DME) and Supplies and groups them into categories: Inexpensive or Routinely Purchased; Capped Rental or Purchased Equipment (rented if anticipated need ≤ six months; ownership transfers when accrued rental payments reach the Medicaid allowable purchase price); Equipment Requiring Frequent and Substantial Servicing (rented, includes oxygen items); Related Supplies (supplies used with beneficiary-owned equipment); Service and Repair (covered over useful life); and Individually Priced Items (manually priced — see Attachment A, Section C). Attachment A lists HCPCS codes, lifetime expectancies, and quantity limits. EPSDT applies for beneficiaries under 21 and EPSDT reviews must be requested via NCTracks when applicable.

Attachments: Attachment A contains claims-related information including the authoritative HCPCS/ICD-10 tables, lifetime expectancies, quantity limits, fee schedule link, and Section D modifier guidance. Attachment B lists items to be provided on the date of discharge from specified facilities. Attachment C provides CMS-1500 claim completion instructions. Attachment D describes the process for requesting unlisted DME and supplies (including manual pricing and NCTracks submission). Refer to these attachments for specific coding, delivery, modifier, and prior approval instructions.

Definitionsmixed

Durable Medical Equipment (DME)	Primarily used to serve a medical purpose, not useful in absence of disability/illness, can withstand repeated use, reusable or removable.
Supplies	Consumable or disposable health-care related items required to address a medical disability, illness, or injury.
NPWT	Negative pressure wound therapy: use of an electrical pump to convey sub-atmospheric pressure to a specialized wound dressing to promote wound healing.
Non-therapeutic CGM	Adjunctive CGM systems that complement, not replace, standard BGMs and must be intermittently calibrated with fingerstick measurements; covered under DME benefit.
Therapeutic CGM	CGM systems approved by FDA for non-adjunctive use to replace BGMs for making diabetes treatment decisions; covered under Pharmacy benefit.
Capped rental	Rental arrangement where the beneficiary becomes owner when total rental payments reach the Medicaid allowable new purchase price.
CMN/PA	Certificate of Medical Necessity/Prior Approval form for DME.
N/A (Rental only)	Item is provided as a rental and not purchased; rental billing rules apply.
Per manufacturer's warranty	Lifetime expectancy or limitation is dictated by the device manufacturer's warranty period.
Manual pricing	Pricing method for items not on fee schedule; requires supporting documentation/quote with PA.

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Definitions_text_blockmixed

No codes listed

Medicare Determinations and References

Reference	Identifier	Type
CMS Home Health Final Rule (Title 42, §440.70)	Title 42, §440.70	Other (Medicare/CMS crosswalk for unlisted DME coverage)
NC Medicaid Clinical Coverage Policy No: 5A-3, Attachment D	Attachment D: Requesting Unlisted DME and Supplies for Adults	Medicaid crosswalk / prior approval process referencing CMS rule
Durable Medical Equipment Fee Schedule (NC Medicaid)	Durable Medical Equipment Fee Schedule (see Attachment A, Section C)	Medicaid fee schedule / list of codes and PA indicators

Revision History

03/01/2003code_replacement

HCPCS code changes: E0452/E0453 deleted and replaced with K0532/K0533 per revision history.

05/15/2002revision_history_note

Revision history documents numerous HCPCS code additions, deletions, replacements, and description updates across multiple dates (2003-2022).

10/01/2019process_change

Providers instructed to submit prior approval (PA) requests for unlisted items through NCTracks rather than directly to NC Medicaid clinical policy; language clarifications and PA-related updates to BGM supply rules.

Policy Summary

PayerAlliance Health

PolicyNursing Equipment and Supplies (Durable Medical Equipment and Supplies)

Policy CodePolicy Clinical Coverage Policy No: 5A-3

Change TypeHCPCS/coverage updates

Effective DateMay 1, 2025

Next Review DateN/A

On This Page

Prior authorization is obtained when required by the payer for the specific item or service.

Specific Criteria Covered for Durable Medical Equipment and Supplies

Covered when ALL of the following criteria are met for Durable Medical Equipment and Supplies:

ALL of the following

The item is primarily medical in nature and used to serve a medical purpose in the home or other ambulatory setting.
The item is not useful to a person in the absence of illness or injury and is not primarily for convenience of the beneficiary or caregiver.
The item is ordered by a qualified licensed provider and is reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member.
Documentation of initial assessment and ongoing need is maintained in the beneficiary’s medical record and available upon request.

Prior Approval Requirements (General)

Prior approval (PA) is required when ANY of the following apply:

ANY of the following

The item is listed on the payer’s prior approval code list.
High-cost devices (e.g., external insulin infusion pumps, wearable cardioverter defibrillators, NPWT devices) where coverage criteria include clinical thresholds or time-limited approvals.
Replacement or upgrade requests that exceed specified frequency or cost limits.
Requests for experimental or investigational devices or unlisted DME codes.
Requests where documentation is incomplete or there is lack of clinical justification for medical necessity.

Negative Pressure Wound Therapy (NPWT) Initial Coverage Criteria

Initial coverage for Negative Pressure Wound Therapy (NPWT) is covered when ALL of the following are met:

ALL of the following

Wound has been assessed by an appropriate clinician and documented in the medical record (type, size, depth, presence of infection).
Wound falls into covered categories such as chronic non-healing wounds (e.g., pressure ulcers stage 3-4, diabetic foot ulcers, venous stasis ulcers) or acute wounds when medically necessary.
Conservative wound care measures have been tried and documented unless contraindicated (e.g., standard dressings, debridement, infection control).
There is objective documentation the wound requires NPWT and that NPWT is expected to promote wound healing or manage exudate.
A plan of care with measurable goals, device settings, frequency of dressing changes, and follow-up monitoring is documented.

NPWT Contraindications (Not Medically Necessary)

Not Medically Necessary / Contraindications for NPWT (coverage denied when ANY apply):

ANY of the following

Wound with untreated osteomyelitis in the wound bed.
Presence of necrotic tissue with eschar not debrided.
Wounds with exposed blood vessels, nerves, organs, or anastomotic sites without appropriate protective measures.
Malignancy in the wound, unless NPWT is being used for palliative management and documented as such.
Active uncontained fistula to organ or body cavity.

NPWT Continued Coverage Criteria

Continued coverage for NPWT (monthly re-approval) is covered when ALL of the following are met:

ALL of the following

There is documented clinical improvement toward established goals (e.g., reduction in wound size or exudate) since prior authorization or last review.
Treatment continues to be reasonable and necessary for the wound and alternatives remain ineffective or inappropriate.
Ongoing plan of care and follow-up visits are documented, including dressing change frequency and device maintenance.
Prior approval is renewed as required by payer policy and documentation submitted supports continued medical necessity.

External Insulin Infusion Pump Coverage Criteria - Beneficiaries aged 0-20

External Insulin Infusion Pump — Coverage Criteria for beneficiaries aged 0-20:

ALL of the following

Diagnosis of type 1 diabetes mellitus documented by a qualified provider.
Demonstrated ongoing need for intensive insulin therapy as evidenced by suboptimal glycemic control (e.g., recurrent severe hypoglycemia or frequent blood glucose excursions) despite optimized MDI and education, or other clinical indications per clinical judgment.
Comprehensive diabetes education provided and documented, including training on pump use, carbohydrate counting, and hypoglycemia management.
Beneficiary and/or caregiver demonstrate ability and willingness to perform required pump management and monitoring tasks (documented competency).
Prescription includes pump model, supplies, anticipated frequency of supply replacement, and plan for remote or in-person follow-up.

Gestational Diabetes - External Insulin Infusion Pump

External Insulin Infusion Pump — Gestational diabetes coverage criteria:

ALL of the following

Gestational diabetes requiring insulin that cannot be managed with multiple daily injections (MDI) or where MDI is contraindicated or not tolerated.
Clinical documentation that intensive insulin therapy via pump is expected to improve glycemic control and pregnancy outcomes.
Close obstetrical and endocrinology follow-up is arranged and documented.
Pump use is time-limited to the period of pregnancy unless ongoing medical necessity after pregnancy is documented.

External Insulin Infusion Pump Prior Approval Requirements (All Beneficiaries)

External Insulin Infusion Pump — Prior approval requirements (all beneficiaries):

ALL of the following

A completed prior authorization request form specific to insulin infusion pumps submitted with current clinical documentation.
Documentation of diagnosis, prior therapies tried (including MDI), reasons MDI is ineffective/contraindicated, and objective measures of glycemic control (e.g., HbA1c, records of hypoglycemic events).
Evidence of diabetes self-management education and training and demonstration of competency by beneficiary/caregiver.
Detailed equipment order including pump model, consumable supplies and quantities, and expected replacement schedule.
Plan for ongoing monitoring and supplies provisioning, including device malfunction and replacement policies.

External Insulin Infusion Pump Replacement Criteria

External Insulin Infusion Pump — Replacement criteria:

ALL of the following

Replacement of pump or major components is covered when the device is no longer functional due to normal wear and tear, and repair is not feasible; documentation of device failure is required.
Replacement for loss or theft may require prior authorization and supporting documentation (police report for theft may be requested).
Routine upgrades or replacements for convenience are not covered unless clinically indicated and prior authorized.
Supplies replacement frequency follows payer-defined quantities and requires documentation when exceeding standard allowances.

Standard Blood Glucose Monitors (BGMs) and Related Supplies - Medically Necessary

Standard blood glucose monitors (BGMs) and related supplies are medically necessary when ALL of the following are met:

ALL of the following

There is a diagnosis of diabetes mellitus requiring blood glucose monitoring and a licensed prescriber’s order for the monitor and supplies.
The chosen monitor is appropriate to the beneficiary’s clinical needs and abilities (e.g., visual impairment, dexterity concerns).
Supplies (test strips, lancets, control solution) quantities ordered are consistent with expected clinical use and payer quantity limits.
Documentation supports need for the monitor and frequency of testing; education on proper use is provided and documented.

BGM with Integrated Voice Synthesizer - Additional Criteria

BGMs with integrated voice synthesizer — additional/modified criteria:

ALL of the following

All standard BGM medical necessity criteria are met.
Beneficiary has severe visual impairment or blindness documented and a BGM with integrated voice synthesizer is required to permit safe, independent self-monitoring of blood glucose.
Alternative accommodations (e.g., caregiver assistance, other accessible devices) are insufficient to meet the beneficiary’s needs or are impractical; documentation required.
Training on the specific voice-capable device is provided and documented in the medical record.

BGMs with Integrated Voice Synthesizer - Medically Necessary

BGMs with integrated voice synthesizer are medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of diabetes mellitus with a prescriber order for an accessible BGM device.
Documented severe visual impairment that prevents use of standard displays and requires voice output for safe monitoring and treatment decisions.
Documentation that beneficiary can use the voice-capable device or has a caregiver who will assist as needed.

Non-therapeutic CGM - First Redetermination

Non-therapeutic Continuous Glucose Monitoring (CGM) — First redetermination (renewal) criteria:

ANY of the following

At least one of the following demonstrates ongoing need: documented improvement in glycemic control attributable to CGM (e.g., HbA1c reduction, fewer hypoglycemic events).
Clinical documentation shows continued frequent hypoglycemia or glycemic variability despite optimized therapy.
Beneficiary/caregiver demonstrates ongoing ability to use the CGM device and adhere to monitoring plan, with documentation of follow-up visits and device data review.
For beneficiaries who met initial criteria based on specific clinical events, documentation that these events continue to occur or that CGM remains clinically indicated.
If initial coverage was limited by time, request for continued coverage must document progress toward goals and plan for continued management.
If initial criteria were met by combination logic (e.g., 1 + 7), documentation must address both branches used at approval.
OR: At least one documented justification that ongoing CGM use remains medically necessary (e.g., continued hypoglycemia unawareness) when other criteria are not applicable.

Non-therapeutic CGM - Annual Redetermination

Non-therapeutic Continuous Glucose Monitoring (CGM) — Annual redetermination criteria:

ANY of the following

Documentation of continued clinical benefit (e.g., improved HbA1c, reduced severe hypoglycemia, improved glycemic variability) since last approval period.
Ongoing documentation of beneficiary engagement, device use, and data review by provider.
If clinical status has changed, documentation supporting continued medical necessity based on current condition and therapy plan.
Requests must include device download or summary data showing usage and impact on management when available.

Phototherapy - Bilirubin Light Therapy

Phototherapy (Bilirubin light therapy) is covered when ALL of the following are met:

ALL of the following

Indication is neonatal hyperbilirubinemia with bilirubin levels meeting established treatment thresholds per age in hours and risk factors (per AAP guidelines or equivalent).
Order is from a qualified provider with documentation of bilirubin level, postnatal age in hours, and relevant risk factors.
Appropriate monitoring is arranged and documented (bilirubin rechecks, hydration and feeding status).

Phototherapy - Ultraviolet Light Therapy

Phototherapy (Ultraviolet light therapy) is covered when ALL of the following are met:

ALL of the following

Diagnosis and documentation that UV phototherapy is indicated for specific dermatologic conditions (e.g., psoriasis, vitiligo) after failure or contraindication to topical/systemic therapies as appropriate.
Treatment plan includes frequency, duration, and monitoring for adverse effects with dermatology follow-up.
Prior authorization obtained when specified by payer policy or for home phototherapy equipment.

Oral Nutrition - Age and Specifics

Oral Nutrition Products (metabolic formulas) — Age and specifics:

ALL of the following

Formulas indicated for metabolic disorders are covered when there is a documented diagnosis of an inborn error of metabolism or other clinically appropriate condition requiring a therapeutic formula.
Age-specific allowances apply; pediatric formulas for infants and children must be ordered by a pediatric specialist when required by policy.
Coverage for standard oral nutrition supplements for non-metabolic indications follows general nutrition policy limits and documentation rules.
EPSDT rules may allow exceptions for beneficiaries under 21 when medically necessary and documented.

Oral Nutrition - Documentation & Re-certification

Oral Nutrition Products — Documentation and re-certification:

ALL of the following

Prescriber order must include medical diagnosis, specific product name, caloric/protein needs, and duration of need.
Initial authorization periods and subsequent re-certifications require documentation of clinical response, weight trends, tolerance, and continued need for the product.
Requests for ongoing coverage must include recent clinical notes and any laboratory or growth data supporting continued use; EPSDT beneficiaries require demonstration of medical necessity per pediatric growth/ development goals.

Enteral Nutrition - Equipment Acquisition Rules

Enteral Nutrition (EN) — Equipment acquisition rules (rental vs purchase):

ALL of the following

Durable enteral pumps and durable equipment are provided according to payer rules for rental versus purchase (e.g., short-term use typically rental; long-term or continuous home use may be purchased when cost-effective).
Clinical justification for purchase rather than rental must be documented, including anticipated duration of need and cost comparison when required by payer.
Accessories and disposable supplies are typically supplied on a consumable basis and quantity limits apply per clinical use and payer schedules.

In-line Digestive Enzyme Cartridges (Relizorb) Coverage Criteria

In-line digestive enzyme cartridges (Relizorb) are covered when ALL apply:

ALL of the following

Beneficiary is receiving enteral tube feeding and has documented exocrine pancreatic insufficiency or demonstrated fat malabsorption attributable to lack of enteral digestion enzyme activity despite optimized pancreatic enzyme replacement therapy when oral enzymes cannot be delivered effectively via the tube.
Prescriber documents expected benefit and plan for monitoring response (weight gain, stool characteristics, fat absorption measures).
Prior authorization obtained when required and detailed orders for cartridge use frequency supplied.

Wearable Cardioverter Defibrillator (WCD) - Ordering, Monitoring, and Prior Approval

Wearable Cardioverter Defibrillator (WCD) — Ordering, monitoring, and prior approval requirements:

ALL of the following

WCD is ordered by an appropriate specialist (e.g., cardiologist) with documentation of indication (e.g., temporary risk of sudden cardiac death while awaiting ICD placement or while condition is reversible).
Prior authorization is required; submitted documentation must include diagnosis, estimated duration of high risk, and plan for transition to permanent therapy if indicated.
Provider must document plan for monitoring adherence, data review from the WCD, and follow-up visits; lack of adherence may affect continued coverage.
Contraindications, device limitations, and any reason for denial must be documented; limits on total rental period apply per payer rules.

Incontinence, Ostomy, and Urinary Catheter Supplies - Coverage

Incontinence, ostomy, and urinary catheter supplies — Coverage criteria:

ALL of the following

Supplies are covered when ordered by a prescriber and when documentation supports medical necessity (e.g., incontinence requiring management, ostomy care after surgery, chronic urinary retention requiring catheterization).
Quantities requested must align with expected clinical use and payer quantity limits; documentation required for higher than typical allowances.
Training and education for beneficiary/caregiver on use and care of supplies should be documented.

Manual Pump-Operated Enema System (e.g., Peristeen) - Coverage

Manual pump-operated enema systems (e.g., Peristeen) — Coverage criteria:

ALL of the following

Indication documented such as neurogenic bowel dysfunction with failed conservative therapy.
Prescriber provides training plan and documentation that beneficiary/caregiver can use the system safely and effectively.
Prior authorization required when specified by payer; documentation of prior conservative measures and expected benefit required.

Electric Breast Pumps - Coverage

Electric breast pumps — Coverage criteria:

ALL of the following

Medically-necessary electric breast pumps are provided in accordance with state and payer-specific lactation benefit policies; prescriber or lactation consultant order may be required per payer.
Coverage may be for a single pump per pregnancy/birth event or as specified by payer limits; replacement rules apply if malfunction documented.
Education on pump use and safe breastfeeding practices should be documented in the medical record.

Miscellaneous DME and Supplies - Medical Necessity Examples

Miscellaneous DME examples that may be medically necessary when documented:

ANY of the following

Specialized beds or support surfaces for pressure injury prevention or treatment when ordered and documented by prescriber.
Braces, orthoses, or walkers when there is functional limitation and documentation supports need.
Nebulizers and respiratory aids when ordered for chronic respiratory conditions and clinical documentation supports home use.
Other DME items determined to be reasonable and necessary based on individual clinical circumstances and supporting documentation.

Provision of DME on Date of Discharge

Provision of DME and supplies on date of discharge from specified facilities:

ALL of the following

For beneficiary discharge from inpatient acute care, inpatient rehab, or skilled nursing facility, DME and supplies ordered at discharge to allow safe transition to home may be provided per policy rules.
Orders must be written prior to discharge and documentation must support medical necessity at the time of discharge.
Quantity and delivery arrangements must follow payer discharge supply limits and documentation requirements.

Amount of Service and Limits

Amount of service and limits:

ALL of the following

Quantities provided for DME and supplies follow payer-established limits and frequency rules unless prior authorized with supporting documentation.
Routine replacement intervals apply; earlier replacement requires documentation of device failure, clinical change, or extraordinary circumstances.
Requests exceeding typical quantities or frequency require prior authorization and clinical justification.

Diabetic Supply Override Process

Diabetic supply override process:

ALL of the following

When beneficiaries require supplies in excess of standard allowances due to clinical need, providers must submit a prior authorization request with documentation explaining the override need (clinical rationale, frequency of testing, special circumstances).
EPSDT beneficiaries may qualify for exception to limits when medically necessary; documentation must demonstrate medical necessity relative to pediatric needs.

Monitoring Enteral Nutrition (EN) - Provider Responsibilities

Monitoring Enteral Nutrition (EN) — Provider responsibilities:

ALL of the following

Providers must document baseline assessment, ongoing monitoring of weight, tolerance, and relevant laboratory studies as clinically indicated.
Regular follow-up visits and communication with DME supplier regarding supplies and equipment functioning are required.
Re-certification requests must include documentation of continued need and any adjustments to formula, caloric goals, or tube feeding regimen.

Changing Suppliers for Rental Items Other Than Oxygen

Changing suppliers for rental items other than oxygen — process and rules:

ALL of the following

Beneficiary may change supplier after initial rental period specified by payer; request should include reason for change and documentation that rental item is in good working order unless change due to documented service issues.
Supplier-to-supplier transfer requires coordination to avoid gaps in service and appropriate return/reclamation of equipment by original supplier per payer rules.

Provider Eligibility and Qualifications to Bill

Provider eligibility and qualifications to bill for DME/EN services:

ALL of the following

Billing providers must meet payer enrollment requirements for DME suppliers and be appropriately licensed and accredited where applicable.
Providers must adhere to documentation, billing, and coding requirements and maintain records to support medical necessity and claims for audit.

Provider Qualifications for DME Enrollment

Provider qualifications for DME enrollment (minimum requirements):

ALL of the following

Suppliers must possess required state licenses, federal DMEPOS accreditation when applicable, and comply with payer enrollment policies.
Staff providing training or durable medical equipment services must be qualified and documented in personnel records.

Home Infusion Therapy (HIT) Providers and Enteral Nutrition (EN)

Home Infusion Therapy (HIT) providers and Enteral Nutrition (EN) — requirements:

ALL of the following

HIT providers furnishing EN must be appropriately licensed and follow payer clinical and billing requirements for home infusion-related enteral services.
Coordination between prescribing clinician, home infusion provider, and DME supplier for supplies and equipment is required and documented.

Accepting Payment

Accepting payment:

ALL of the following

Providers must accept payment in accordance with payer contracts and not balance-bill beneficiaries for covered services beyond copays or cost-sharing allowed by program rules.
Providers should identify and pursue other payers where appropriate (e.g., Medicare coordination) before billing the payer when other primary coverage exists.

Record Keeping Requirements

Record keeping requirements:

ALL of the following

Providers must maintain complete medical records that document medical necessity, orders, delivery, training, and follow-up for DME/EN services for the time period required by law and payer policy.
Records must be made available upon request for audits and prior authorization reviews.

Reclamation of Equipment

Reclamation of equipment (supplier responsibilities):

ALL of the following

Suppliers must attempt to reclaim reusable equipment when rental terminates or when beneficiaries change suppliers; documentation of attempted reclamation must be retained.
Failure to return equipment may result in billing for purchase if allowed by payer rules; suppliers must follow payer guidance for reclamation and disposal of equipment.

Unlisted DME and Supplies Request Requirements (Adults)

Unlisted DME and supplies — request requirements (adults):

ALL of the following

Requests for unlisted DME codes must include clinical justification, item description, manufacturer documentation, and cost information compared to standard alternatives.
Prior authorization is required for unlisted items; requests should include photographs, product specifications, and rationale why no listed code applies.

Submitting Unlisted DME Requests

Submitting unlisted DME requests — operational requirements:

ALL of the following

Use payer-specific prior authorization forms and submission portals; include complete clinical documentation and supplier quotes or invoices as applicable.
Allow sufficient lead time for review; incomplete submissions will be returned and may delay service provision.

CMS-1500 Claim Completion Rules for DME/EN Services

CMS-1500 claim completion rules for DME/EN services:

ALL of the following

Claims must include correct HCPCS/CPT codes, modifiers, accurate dates of service, place of service, and supporting documentation as required by payer.
Supplier National Provider Identifier (NPI), supplier tax ID, beneficiary identifiers, and prescriber information must be included per CMS and payer requirements.
Use of appropriate revenue codes and linkage to prior authorization approvals (when required) must be documented on claim submission.

Billing Rule

Bill third parties before Medicaid

If a third party (e.g., Medicare or private insurer) is liable, providers shall bill the third party before billing Medicaid and follow NCTracks provider guidance.

Prior Authorization

Submit prior approval requests via NCTracks for unlisted items

Providers must submit PA requests for unlisted DME and supplies via NCTracks per the Attachment D instructions; if no HCPCS exists use E1399/W4047 (non-wheelchair) or K0108/W4005 (wheelchair accessories).

Submit completed CMN/PA and supportive documentation through NCTracks
Use E1399/W4047 or K0108/W4005 when no specific HCPCS exists

10/15/2020pa_removal_and_coverage_update

Removed prior authorization requirement for blood glucose monitors with integrated voice synthesizer and updated CGM coverage rules (therapeutic CGM moved to Pharmacy benefit; non-therapeutic CGM covered under DME).

05/15/2022pa_removal

Removed prior authorization requirement for HCPCS E0202 (phototherapy bilirubin light); updated monthly supply day counts to 31 days for some items.

11/01/2016policy_alignment

Mirrored Medicare shipping/delivery and oxygen recertification policies and extended some initial authorizations (e.g., NPWT initial auth extended to 6 months).

07/01/2017organizational_renumbering

Policy split into categorical policies (5A-1, 5A-2, 5A-3) for alignment with CMS rules; change was technical with no substantive coverage change.

03/01/2023code_additions_and_limits

Added coverage and quantity limits for multiple HCPCS codes (examples: A4238, E2102 added earlier; various EN and supply codes added/updated per Attachment A changes).

01/15/2024clinical_criteria_added

Added medical necessity criteria for replacement blood pressure cuffs and updated related coverage/lifetime expectancy entries in Attachment A.

03/01/2025terminology_standardization_and_icd_updates

Standardized terminology from 'prior authorization' variants to 'prior approval', updated CMN/PA block references, added Clinical Coverage Policy 3D (Hospice), and added ICD-10 codes E10A0/E10A1/E10A2 effective 10/01/2024.

03/01/2025code_removal_replacement

Removed HCPCS codes A9276/A9277/A9278 and end-dated coverage 01/31/2025 as replaced by codes A4238 and E2102; added coverage/quantity limits for A4271 and E2104 effective 04/01/2024 and A4332 effective 02/01/2025.

03/01/2025 (amended May 1, 2025)terminology_and_submission_changeLatest

Policy language standardized to 'prior approval'; NCTracks is the required submission portal for PAs (including unlisted item requests); multiple Attachment A code updates and modifier clarifications included in March 2025 amendments.

03/01/2025code_additionLatest

Added ICD-10 codes E10A0, E10A1, E10A2 to blood glucose monitors and related supplies (effective 10/01/2024) as part of the 03/01/2025 update.

03/01/2025code_end_dateLatest

End-dated HCPCS codes A9276, A9277, A9278 (coverage ended 01/31/2025) with replacement coding via A4238 and E2102 per Attachment A revisions.

04/01/2024 (noted in 03/01/2025 revision)quantity_limits_added

Coverage and quantity limits added for HCPCS codes A4271 and E2104 effective 04/01/2024 (documented in March 2025 updates).

02/01/2025 (noted in 03/01/2025 revision)code_addition

Coverage and quantity limits added for HCPCS code A4332 effective 02/01/2025 (recorded in March 2025 revision notes).

05/15/2022 (effective 11/01/2021)rental_day_adjustment

Updated maximum rental days for certain items from 30 to 31 calendar days (e.g., E0202 rental days updated to 31; PA removal for E0202 noted).

05/15/2022examples_surface

Examples surfaced in revision notes include code replacements (E0452/E0453 -> K0532/K0533), PA removals (E0202), code additions (E0482, T4544), and many other HCPCS updates across revision history.