Urological Supplies

None

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
• Refer to the Supplier Manual for additional information on documentation requirements.
• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

The statutory coverage criteria for coverage of urological supplies are specified in the related Policy Article.

The medical necessity for use of a greater quantity of supplies than the amounts specified in the policy must be well documented in the beneficiary's medical record and must be available upon request.

INDWELLING CATHETERS (A4311, A4312, A4313, A4314, A4315, A4316, A4338, A4340, A4344, and A4346)

No more than one catheter per month is covered for routine catheter maintenance. Non-routine catheter changes are covered when documentation substantiates medical necessity, such as for the following indications:

1. Catheter is accidentally removed (e.g., pulled out by beneficiary)
2. Malfunction of catheter (e.g., balloon does not stay inflated, hole in catheter)
3. Catheter is obstructed by encrustation, mucous plug, or blood clot
4. History of recurrent obstruction or urinary tract infection for which it has been established that an acute event is prevented by a scheduled change frequency of more than once per month

A specialty indwelling catheter (A4340) or an all silicone catheter (A4344, A4312, or A4315) is covered when the criteria for an indwelling catheter (above) are met and there is documentation in the beneficiary's medical record to justify the medical need for that catheter (such as recurrent encrustation, inability to pass a straight catheter, or sensitivity to latex(not all-inclusive)). In addition, the particular catheter must be necessary for the beneficiary. If documentation is requested and does not substantiate medical necessity payment for A4340, A4344, A4312, or A4315 will be denied as not reasonable and necessary.

A three way indwelling catheter either alone (A4346) or with other components (A4313 or A4316) will be covered only if continuous catheter irrigation is reasonable and necessary. (Refer to the section "Continuous Irrigation of Indwelling Catheters" for indications for continuous catheter irrigations.) In other situations, A4346, A4313 and A4316 will be denied as not reasonable and necessary.

CATHETER INSERTION TRAY (A4297, A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, and A4354)

One insertion tray will be covered per episode of indwelling catheter insertion. More than one tray per episode will be denied as not reasonable and necessary.

One intermittent catheter with insertion supplies (A4297, A4353) will be covered per episode of reasonable and necessary sterile intermittent catheterization (see below).

URINARY DRAINAGE COLLECTION SYSTEM (A4314, A4315, A4316, A4354, A4357, A4358, A5102, and A5112)

Payment will be made for routine changes of the urinary drainage collection system as noted below. Additional charges will be allowed for reasonable and necessary non-routine changes when the documentation substantiates the medical necessity, (e.g., obstruction, sludging, clotting of blood, or chronic, recurrent urinary tract infection).

Usual Maximum Quantity of Supplies:

Leg bags are indicated for beneficiaries who are ambulatory or are chair or wheelchair bound. The use of leg bags for bedridden beneficiaries would be denied as not reasonable and necessary.

If there is a catheter change (A4314, A4315, A4316, A4354) and an additional drainage bag (A4357) change within a month, the combined utilization for A4314, A4315, A4316, A4354, and A4357 should be considered when determining if additional documentation should be submitted with the claim. For example, if 1 unit of A4314 and 1 unit of A4357 are provided, this should be considered as two drainage bags, which is the usual maximum quantity of drainage bags needed for routine changes.

Payment will be made for either a vinyl leg bag (A4358) or a latex leg bag (A5112). The use of both is not reasonable and necessary.

The medical necessity for drainage bags containing absorbent material such as gel matrix or other material, which are intended to be disposed of on a daily basis has not been established. Claims for this type of bag will be denied as not reasonable and necessary.

INTERMITTENT IRRIGATION OF INDWELLING CATHETERS

Supplies for the intermittent irrigation of an indwelling catheter are covered when they are used on an as needed (non-routine) basis in the presence of acute obstruction of the catheter. Routine intermittent irrigations of a catheter will be denied as not reasonable and necessary. Routine irrigations are defined as those performed at predetermined intervals. In individual cases, a copy of the order for irrigation and documentation in the beneficiary's medical record of the presence of acute catheter obstruction may be requested when irrigation supplies are billed.

Covered supplies for reasonable and necessary non-routine irrigation of a catheter include either an irrigation tray (A4320) or an irrigation syringe (A4322), and sterile water/saline (A4217). When syringes, trays, sterile saline, or water are used for routine irrigation, they will be denied as not reasonable and necessary. Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. Irrigating solutions such as acetic acid or hydrogen peroxide, which are used for the treatment or prevention of urinary obstruction (A4321), will be denied as not reasonable and necessary.

CONTINUOUS IRRIGATION OF INDWELLING CATHETERS

Supplies for continuous irrigation of a catheter are covered if there is a history of obstruction of the catheter and the patency of the catheter cannot be maintained by intermittent irrigation in conjunction with reasonable and necessary catheter changes. Continuous irrigation as a primary preventative measure (i.e., no history of obstruction) will be denied as not reasonable and necessary. Documentation must substantiate the medical necessity of catheter irrigation and in particular continuous irrigation as opposed to intermittent irrigation. The records must also indicate the rate of solution administration and the duration of need. This documentation must be available upon request.

Covered supplies for reasonable and necessary continuous bladder irrigation include a 3-way Foley catheter (A4313, A4316, and A4346), irrigation tubing set (A4355), and sterile water/saline (A4217). More than one irrigation tubing set per day for continuous catheter irrigation will be denied as not reasonable and necessary.

Irrigation solutions containing antibiotics and chemotherapeutic agents (A9270) will be denied as non-covered. Payment for irrigating solutions such as acetic acid or hydrogen peroxide will be based on the allowance for sterile water/saline (A4217).

Continuous irrigation is a temporary measure. Continuous irrigation for more than 2 weeks is rarely reasonable and necessary. The beneficiary's medical records should indicate this medical necessity and these medical records must be available upon request.

INTERMITTENT CATHETERIZATION

Intermittent catheterization is covered when basic coverage criteria are met and the beneficiary or caregiver can perform the procedure.

For each episode of covered catheterization, Medicare will cover:

1. One catheter (A4351, A4352) and an individual packet of lubricant (A4332); or
2. One catheter (A4295, A4296); or,
3. One sterile intermittent catheter kit (A4297, A4353) if additional coverage criteria (see below) are met.

Intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-5):

1. The beneficiary resides in a nursing facility,
2. The beneficiary is immunosuppressed, for example (not all-inclusive):
   • on a regimen of immunosuppressive drugs post-transplant,
   • on cancer chemotherapy,
   • has AIDS,
   • has a drug-induced state such as chronic oral corticosteroid use,
   • has a diagnosis of spinal cord injury at any level. (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article).
3. The beneficiary has radiologically documented vesico-ureteral reflux while on a program of intermittent catheterization,
4. The beneficiary has had distinct, recurrent urinary tract infections, while on a program of sterile intermittent catheterization with either A4295/A4296 with no sterile lubricant (A4332), or A4351/A4352 with sterile lubricant (A4332), twice within the 12-months prior to the initiation of sterile intermittent catheter kits.

A beneficiary would be considered to have a urinary tract infection if they have a urine culture with greater than 10,000 colony forming units of a urinary pathogen AND concurrent presence of one or more of the following signs, symptoms or laboratory findings:

• Fever (oral temperature greater than 38º C [100.4º F])
• Systemic leukocytosis
• Change in urinary urgency, frequency, or incontinence
• Appearance of new or increase in autonomic dysreflexia (sweating, bradycardia, blood pressure elevation)
• Physical signs of prostatitis, epididymitis, orchitis
• Increased muscle spasms
• Pyuria (greater than 5 white blood cells [WBCs] per high-powered field)

Usual Maximum Quantity of Supplies:

Refer to Coding Guidelines section of the related Policy Article for contents of the kit (A4297, A4353). A4297 or A4353 should not be used for billing if the components are packaged separately rather than together as a kit. Separately provided components do not provide the equivalent degree of sterility achieved with an A4297 or A4353. If separate components are provided instead of a kit (A4297, A4353) they will be denied as not reasonable and necessary.

The maximum quantity of sterile catheterization kits (A4297, A4353) is 200 units per month. Billing more than 200 units per month total for A4297 and A4353 will be denied as not reasonable and necessary.

When a Coude tip catheter (A4296, A4352) is used, there must be documentation in the beneficiary's medical record of the medical necessity for that catheter. An example would be the inability to catheterize with a straight tip catheter. This documentation must be available upon request. If documentation is requested and does not substantiate medical necessity, claims will be denied as not reasonable and necessary.

EXTERNAL CATHETERS/URINARY COLLECTION DEVICES

Male external catheters (condom-type) or female external urinary collection devices are covered for beneficiaries who have permanent urinary incontinence when used as an alternative to an indwelling catheter.

The utilization of male external catheters (A4349) generally should not exceed 35 per month. Greater utilization of these devices must be accompanied by documentation of medical necessity.

Male external catheters (condom-type) or female external urinary collection devices will be denied as not reasonable and necessary when ordered for beneficiaries who also use an indwelling catheter.

Specialty type male external catheters (A4326) such as those that inflate or that include a faceplate or extended wear catheter systems are covered only when documentation substantiates the medical necessity for such a catheter. If documentation does not justify the medical need claims will be denied as not reasonable and necessary.

For female external urinary collection devices, more than one meatal cup (A4327) per week or more than one pouch (A4328) per day will be denied as not reasonable and necessary.

INITIAL COVERAGE FOR THE INFLOW DEVICE

The inFlow device (A4341) is considered to be reasonable and necessary as an alternative to intermittent catheterization for beneficiaries with Permanent Urinary Retention (PUR) due to Impaired Detrusor Contractility (IDC).

One (1) inFlow device may be covered no more than once every 29 days. Claims for the inFlow device billed more than once every 29 days will be denied as not reasonable and necessary.

CONTINUED COVERAGE FOR THE INFLOW DEVICE BEYOND THE FIRST THREE MONTHS OF THERAPY

Continued coverage of the inFlow device beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must conduct a clinical re-evaluation and document that the beneficiary continues to use and is benefiting from the inFlow device.

Documentation of use and clinical benefit is demonstrated by:

1. An in-person encounter by the treating practitioner with documentation that urinary symptoms are improved; and,
2. The treating practitioner verifies the beneficiary’s adherence to use of the inFlow device.

If the above criteria are not met, continued coverage of the inFlow device and related accessories will be denied as not reasonable and necessary.

If the practitioner re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the beneficiary is benefiting from the inFlow device as defined in criteria 1 and 2 above, continued coverage of the inFlow device will commence with the date of that re-evaluation.

If there is discontinuation of usage of the inFlow device at any time, the supplier is expected to ascertain this and stop billing for the equipment and related accessories and supplies.

MISCELLANEOUS SUPPLIES

Appliance cleaner (A5131) is covered when used to clean the inside of certain urinary collecting appliances (A5102, A5105, A5112). More than one unit of service (16 oz.) per month is rarely reasonable and necessary.

One external urethral clamp or compression device (A4356) is covered every 3 months or sooner if the rubber/foam casing deteriorates.

Tape (A4450, A4452) which is used to secure an indwelling catheter to the beneficiary's body is covered. More than 10 units (1 unit = 18 sq. in.; 10 units = 180 sq. in. = 5 yds. of 1 inch tape) per month will be denied as not reasonable and necessary.

Adhesive catheter anchoring devices (A4333) and catheter leg straps (A4334) for indwelling urethral catheters are covered. More than 3 per week of A4333 or 1 per month of A4334 will be denied as not reasonable and necessary. A catheter/tube anchoring device (A5200) is covered and separately payable when it is used to anchor a covered suprapubic tube or nephrostomy tube. If code A5200 is used to anchor an indwelling urethral catheter, the claim will be denied as not reasonable and necessary.

Urethral inserts (A4336) are covered for adult females with stress incontinence (refer to the ICD-10 Codes section in the LCD-related Policy Article for applicable diagnoses) when basic coverage criteria are met and the beneficiary or caregiver can perform the procedure. They are not indicated for women:

• With bladder or other urinary tract infections (UTI)
• With a history of urethral stricture, bladder augmentation, pelvic radiation or other conditions where urethral catheterization is not clinically advisable
• Who are immunocompromised, at significant risk from UTI, interstitial cystitis, or pyelonephritis, or who have severely compromised urinary mucosa
• Unable to tolerate antibiotic therapy
• On anticoagulants
• With overflow incontinence or neurogenic bladder

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary, and document an affirmative response, prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are expected to end, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee and document an affirmative response, prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request and an affirmative response from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) - month quantity at a time.

Spinal cord injury (SCI) is commonly viewed as a problem of motor control and sensory loss, resulting in at least partial paralysis.¹ Traumatic SCI also impairs sensorimotor and autonomic function, resulting in a constellation of life-long health complications.² Emerging data show that pathogens more easily infect individuals with SCI; because, SCI disrupts neural and humoral control of immune cells, culminating with the development of "SCI-induced immune deficiency syndrome" (SCI-IDS).³ It is believed that SCI-IDS is associated with exaggerated activation of sympathetic preganglionic neurons (SPNs) i.e., sympathetic hyperreflexia. As the post-injury survival time lengthens, mass recruitment and anomalous sprouting of excitatory interneurons within the spinal cord increase spinal sympathetic reflex excitability, resulting in an excess sympathetic output that disrupts the immune response.⁴

Mechanisms for SCI in the Medicare population may be traumatic or non-traumatic. Non-traumatic causes include epidural abscesses, epidural hematomas, metastatic disease with epidural spinal cord compression, intradural tumors, and surgical complications.⁵ Between 2013 and 2018, the number of Medicare patients with non-traumatic spinal cord injury (SCI) increased by more than 22% from 14,149 to 17,275.⁶ Data describing the levels of spinal cord injury were not reported.

Falls are the leading cause of SCI in patients over 65 years of age.⁵ Within the context of a growing geriatric population, the rising number of falls has led to an increase in the median age of patients with initial traumatic SCI. Other leading causes of trauma-related SCI include motor vehicle accidents (MVA) and sports and recreation accidents.⁵ Between 2002 and 2005, the number of Medicare fee-for-service cases (65 years or older) was 608 and 840, respectively. This represented an increase of 38.1%.⁷ The distribution of traumatic spinal injury levels in this study reported that approximately 30% of patients had an incomplete C01 to C04 injury, and approximately 28% had an incomplete C05 to C08 injury. The next most frequent diagnoses were lumbar injury (~12%) and incomplete injuries within the T07 to T12 levels (~9%).

In a comprehensive systematic review and meta-analysis, the immune status difference between individuals with and without traumatic SCI was investigated by examining their peripheral immune cells and markers.⁸ A total of 90 studies, eight focused on the impact on the urinary tract, were included in the review. Of these, 54 (60%) studies were suitable for meta-analysis including three that were related to the urinary tract. In sum, 22 immune biomarkers were obtained from 3191 study participants in the meta-analysis. The results broadly support the diminished immune status of individuals with SCI compared to those without SCI. The findings showed that in contrast to individuals without SCI, individuals with SCI had significantly higher mean peripheral leukocyte concentration, significantly higher mean peripheral cytokine concentrations, and significantly lower peripheral immune cell functions in the chronic phase. However, the findings are mostly based on cross-sectional studies, which should be interpreted cautiously due to the potential risk of reverse causality. Additionally, the discrete effects of studies focused on the urinary tract could not be singled out.

Emerging data suggest that a dysfunctional immune response in the bladder may significantly contribute to the propensity to develop infections after SCI. Research using animal studies has shown rats with neurogenic bladder (NGB) due to SCI are more susceptible to urinary tract infections (UTIs), take longer to clear infections, and display a heightened inflammatory response to infection at late time points compared to normal voiding controls.⁹ Clinical studies have also shown that individuals with SCI are particularly susceptible to infectious diseases.⁴ Patients with SCI average 2.5 symptomatic UTIs per year.¹⁰ Persons with SCI experience twice as many hospitalizations as the general population.¹¹ Genitourinary pathologies (eg, UTIs) are the single most common secondary medical complication after SCI.^12-14

Some preclinical research studies suggest that the magnitude and consequences of neurogenic-mediated immune suppression vary due to the spinal injury level. For example, SCI occurring at or above the thoracic 6 (T6) spinal level causes greater immunological impairment with more frequent and severe infections, than if a spinal injury were to occur below T6.^15,16 These spinal-level dependent differences implicate a break in autonomic control over immune function as a principal component of SCI-IDS.¹⁷ In contrast, an animal model study showed increased sensitivity to viral infection is not injury-level dependent; mice with high (T3) and low (T9) SCI had increased viral load and increased mortality in comparison to uninjured mice when exposed to an infectious challenge (mouse hepatitis virus).¹⁸

Urinary catheters are a mainstay management strategy for patients with NGB after SCI. Clean intermittent catheterization (CIC) is the preferred drainage method in patients with NGB if their dexterity, caretaker support, and body habitus allow access. However, CIC increases the risk of UTI caused by catheter contamination resulting in the introduction of external microorganisms into the bladder environment.^10,19 A high antibiotic resistance rate and an increasing prevalence of infection with multidrug-resistant (MDR) bacteria in the SCI inpatient population have been strongly correlated with the use of CIC.^20,21

Kopp, et al (2023) conducted an international prospective multicenter cohort study (SCIentinel; n = 111 patients) to investigate the hypothesis that SCI causes an acquired lesion-dependent (neurogenic) immune suppression as an underlying mechanism to facilitate infections.²² The study was designed to distinguish neurogenic from general trauma-related effects on the immune system. To differentiate SCI-related, neurogenic effects from stress-associated effects after trauma, both patients with acute traumatic SCI and vertebral fractures without SCI were included. SCI patients were grouped by differing neurological level i.e., high SCI (T4 or higher); low SCI (T5 or lower), and severity (complete SCI; incomplete SCI) and were compared with a reference group of vertebral fracture (VF) patients without SCI. Strict eligibility criteria were established to reduce immunological, traumatological, and pharmacological confounding.

The primary outcome was quantitative monocytic Human Leukocyte Antigen-DR expression (mHLA-DR, the number of anti-HLA-DR antibodies bound per monocyte), a validated marker for immune suppression in critically ill patients associated with infection susceptibility.²³ The mean quantitative mHLA-DR [ln (antibodies/cell)] levels at the primary endpoint 84 hours after injury indicated all groups dropped into the range indicating immune suppression i.e., below the normative value of 9.62. The results were further differed by neurological level: high SCI [8.95 (98.3% confidence interval, CI: 8.63 - 9.26), n = 41], low SCI [9.05 (98.3% CI: 8.73 - 9.36), n = 29], and VF without SCI [9.25 (98.3% CI: 8.97 - 9.53), n = 41, P = 0.003].

Post hoc analysis accounting for SCI severity revealed the most substantial mHLA-DR decrease [8.79 (95% CI: 8.50- 9.08)] in the complete, high SCI group [9.08 (95% CI: 8.82- 9.38)] and showing a difference from the VF controls of −0.43 (95% CI: −0.66 to −0.20) at 14 days. Low mHLA-DR levels in the range of borderline immunoparalysis (below 9.21) were positively associated with the occurrence and earlier onset of infections.

Additional regression analyses showed no significant differences in the results associated with patient sex or age. A sensitivity analysis found that the results were very similar to those after multiple imputation for the primary endpoint at 84 hours and in the post hoc analysis.

Immunosuppression in patients with SCI:

The body of evidence shows individuals diagnosed with SCI experience immune suppression, which is directly and indirectly consequential to spinal cord damage. While the magnitude is greatest at higher spinal levels, immunosuppression occurs regardless of the vertebral level affected or the severity of SCI.

Addition of HCPCS codes A4295, A4296, A4297:

The First Biannual (B1), 2024 HCPCS Coding Cycle includes HCPCS Level II coding decisions related to intermittent urinary catheters. The Centers for Medicare and Medicaid Services (CMS) finalized a decision to revise existing HCPCS Level II codes A4351 and A4352 to remove language related to hydrophilic coating. Three new HCPCS Level II codes were established for intermittent urinary catheters with hydrophilic coating: A4295 (Intermittent urinary catheter; straight tip, hydrophilic coating, each), A4296 (Intermittent urinary catheter; coude (curved) tip, hydrophilic coating, each), and A4297 (Intermittent urinary catheter; hydrophilic coating, with insertion supplies).²⁴ A hydrophilic catheter is a type of (not same as) pre-lubricated catheter having a polymer coating that binds water to the catheter to make it slippery. The hydrophilic coating on a catheter is intrinsic to the catheter product (i.e., you cannot wipe the coating off).²⁵ Because hydrophilic catheters are self-lubricating, the use of a separate lubrication product is not necessary.

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO
• Medical Record Information (including continued need/use if applicable)
• Correct Coding
• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

MISCELLANEOUS

APPENDICES

UTILIZATION GUIDELINES

Refer to Coverage Indications, Limitations, and/or Medical Necessity

1. DiSabato DJ, Marion CM, Mifflin KA, et al. System failure: Systemic inflammation following spinal cord injury. Eur J Immunol. 2024;54(1):e2250274. doi:10.1002/eji.202250274
2. Platt JA, Nagata S, Zahl M, Li J, Rosenbluth JP. Problematic secondary health conditions among adults with spinal cord injury and its impact on social participation and daily life. J Spinal Cord Med. 2016;39(6):693-698. doi:10.1080/10790268.2015.1123845
3. Rodgers KA, Kigerl KA, Schwab JM, Popovich PG. Immune dysfunction after spinal cord injury - A review of autonomic and neuroendocrine mechanisms. Curr Opin Pharmacol. 2022;64:102230. doi:10.1016/j.coph.2022.102230
4. Yang P, Bian ZQ, Song ZB, Yang CY, Wang L, Yao ZX. Dominant mechanism in spinal cord injury-induced immunodeficiency syndrome (SCI-IDS): sympathetic hyperreflexia. Rev Neurosci. 2023;35(3):259-269. Published 2023 Oct 30. doi:10.1515/revneuro-2023-0090
5. Arul K, Ge L, Ikpeze T, Baldwin A, Mesfin A. Traumatic spinal cord injuries in geriatric population: etiology, management, and complications. J Spine Surg. 2019;5(1):38-45. doi:10.21037/jss.2019.02.02
6. Deutsch A, Burns J, Potelle J, Kessler A. Trends in the characteristics and outcomes of older patients with non-traumatic spinal cord injury treated in inpatient rehabilitation facilities: 2013-2018. J Spinal Cord Med. Published online April 8, 2024. doi:10.1080/10790268.2024.2335414
7. Deutsch A, Almagor O, Rowles D, Pucci D, Chen D. Characteristics and outcomes of aged Medicare beneficiaries with a traumatic spinal cord injury: 2002-2005. Top Spinal Cord Inj Rehabil. 2011;16(4):17-26. doi.org/10.1310/sci1604-17
8. Valido E, Boehl G, Krebs J, et al. Immune Status of Individuals with Traumatic Spinal Cord Injury: A Systematic Review and Meta-Analysis. Int J Mol Sci. 2023;24(22):16385. Published 2023 Nov 16. doi:10.3390/ijms242216385
9. Balsara ZR, Ross SS, Dolber PC, Wiener JS, Tang Y, Seed PC. Enhanced susceptibility to urinary tract infection in the spinal cord-injured host with neurogenic bladder. Infect Immun. 2013;81(8):3018-3026. doi:10.1128/IAI.00255-13
10. McKibben MJ, Seed P, Ross SS, Borawski KM. Urinary Tract Infection and Neurogenic Bladder. Urol Clin North Am. 2015;42(4):527-536. doi:10.1016/j.ucl.2015.05.006
11. Herrity AN, Castillo C, Isakov RV, et al. Health Care Utilization and Cost Associated With Urinary Tract Infections in a Privately Insured Spinal Cord Injury Population. Top Spinal Cord Inj Rehabil. 2023;29(1):108-117. doi:10.46292/sci22-00022
12. Cardenas DD, Hoffman JM, Kirshblum S, McKinley W. Etiology and incidence of rehospitalization after traumatic spinal cord injury: A multicenter analysis. Arch Phys Med Rehabil. 2004;85:1757-1763.
13. DeJong G, et al. Rehospitalization in the first year of traumatic spinal cord injury after discharge from medical rehabilitation. Arch Phys Med Rehabil. 2013;94:S87-97.
14. Van Kerrebroeck PE, Koldewijn EL, Scherpenhuizen S, Debruyne FM. The morbidity due to lower urinary tract function in spinal cord injury patients. Paraplegia. 1993;31(5):320-329. doi:10.1038/sc.1993.56
15. Brommer B, Engel O, Kopp MA, et al. Spinal cord injury-induced immune deficiency syndrome enhances infection susceptibility dependent on lesion level. Brain. 2016;139(Pt 3):692-707. doi:10.1093/brain/awv375
16. Lucin KM, Sanders VM, Jones TB, Malarkey WB, Popovich PG. Impaired antibody synthesis after spinal cord injury is level dependent and is due to sympathetic nervous system dysregulation. Exp Neurol. 2007;207(1):75-84. doi:10.1016/j.expneurol.2007.05.019
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