ModifiedUnitedHealthcarePolicy CSOS7TN.M

Home Hemodialysis (for Tennessee Only)

Policy governs coverage of home hemodialysis (HHD) for Tennessee Medicaid and CoverKids members, including both unassisted HHD and staff‑assisted (skilled) HHD, and describes clinical eligibility and related coding references.

Policy Summary

PayerUnitedHealthcare

PolicyHome Hemodialysis (for Tennessee Only)

Policy CodePolicy CSOS7TN.M

Change TypeCoverage criteria revised

Effective DateJun 1, 2025

Next Review Date

Key ActionConfirm plan-specific authorization rules and benefit terms before proceeding with home hemodialysis without skilled care.

SourceLink

POLICY UPDATE CHANGES

Updated coverage criteria for home hemodialysis without skilled care as an alternative to facility-based hemodialysis for treating individuals with end-stage renal disease.

2 modalitiesCoverage addressed

3x/weekTypical in-center freq.

10NxStage assessment studies

349 vs 1,047Example matched cohort

3.76 vs 6.27

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All-cause mortality rate (Ok et al.)

Coverage Criteria for Home Hemodialysis

Medical necessity criteria for HHD

Covered when ALL of the following are met:

Unassisted (no skilled care) Home Hemodialysis: Individual or non-professional caregiver is able to perform and maintain home hemodialysis and has received comprehensive training regarding proper protocol; individual is stable on dialysis with no evidence that skilled care interventions are necessary during treatments; absence of complications and significant concomitant disease that would make HHD unsafe or unsuitable; individual has well-functioning vascular access.

Staff-assisted (skilled) Home Hemodialysis: Individual or non-professional caregiver is not capable of performing HHD; individual is stable on dialysis and not at increased risk as a result of having the procedure performed outside a dialysis center venue; individual has medical contraindications to leaving home for hemodialysis; staff-assisted HHD protocols generally match those provided in the hemodialysis center (i.e., typically 3 times per week; 3–4-hour treatments) with exact therapy determined by the attending nephrologist; individual has well-functioning vascular access.

Evidence summary relevant to coverage

Evidence highlights and implications:

Mortality and survival: Observational cohorts and meta-analyses frequently report lower mortality or improved long-term survival with HHD or intensive HD modalities (e.g., Ok et al. reported a 40% lower adjusted risk of all-cause mortality for extended HHD vs in-center HD), but randomized trial evidence is limited and overall strength of evidence is low; observational designs are subject to selection bias.

Observational designs and potential residual confounding noted.

Cardiovascular endpoints: Frequent hemodialysis (FHN Daily) demonstrated reductions in left ventricular mass and ventricular volumes and improved blood pressure control; nocturnal trials did not consistently show LV mass benefit. Improved volume control is a consistent mechanism for cardiovascular benefit.

Benefits larger in some subgroups (eg, low residual urine output or baseline LV hypertrophy).

Quality of life and recovery time: Frequent HD is associated with improvements in patient-reported general health and shorter time to recovery after sessions in several trials (FHN Daily), though results vary across settings and study designs.

Self-reported measures improved in some trials but not uniformly.

Home hemodialysis (without skilled care) — coverage rationale

Covered when ALL of the following are met:

Home HHD coverage criteria: Individual has end-stage renal disease AND home hemodialysis is being considered as an alternative to facility-based hemodialysis without skilled care; individual has well-functioning vascular access; individual meets the medical necessity criteria for unassisted HHD (ability/training to perform and maintain HHD, clinical stability on dialysis, and absence of complications or comorbidities that make HHD unsafe).

Policy rationale updated to allow home HHD without skilled care; wording changed to 'individual has well-functioning vascular access'.

Coverage for home hemodialysis requires demonstration that the patient or non‑professional caregiver can perform and maintain treatments and has completed comprehensive training. In addition, the individual must be clinically stable on dialysis with no evidence that skilled care interventions are necessary during treatments, have no complications or comorbid conditions that would render home therapy unsafe, and have well‑functioning vascular access. These conditions are required for unassisted HHD and are also reflected in staff‑assisted (skilled) HHD criteria where the attending nephrologist determines the exact therapy.

Randomized trials and systematic reviews report increased vascular access procedures and other access‑related harms with more frequent or longer hemodialysis compared with usual care. Trials of nocturnal or extended regimens noted trends toward more access interventions and accelerated loss of residual renal function, findings that may contraindicate intensive regimens in some patients and warrant careful documentation and monitoring.

The NKF/KDOQI Work Group stated that there are no randomized trials of home short frequent hemodialysis and therefore developed guidance only for in‑center short frequent HD. Given inconclusive efficacy data and potential for increased harms, the group made no firm recommendation in favor of home long frequent hemodialysis.

Systematic reviews that included trials of earlier dialysis initiation found that starting dialysis earlier in asymptomatic advanced CKD did not reduce all‑cause mortality compared with later initiation. These analyses concluded that earlier initiation and routine use of dialysis in asymptomatic patients are not supported by high‑quality evidence of improved survival.

Available evidence does not demonstrate a consistent mortality benefit for more frequent or extended hemodialysis. Some trials report improvements in intermediate outcomes (left ventricular mass, blood pressure, time‑to‑recovery, and patient‑reported measures), but the overall strength of evidence is low and multiple studies document increased vascular access interventions and other harms. Therefore, frequent or extended HD has not shown reduced mortality and may increase procedure‑related harms.

Applicable Codes and Device Listings

Referenced procedure/HCPCS/CPT codesmixed

90963	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients younger than 2 years of age
90964	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 2-11 years of age
90965	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 12-19 years of age
90966	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 20 years of age and older
90967	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, for patients younger than 2 years of age
90968	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, for patients 2-11 years of age
90969	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, for patients 12-19 years of age
90970	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, for patients 20 years of age and older
90989	Dialysis training, patient; including helper where applicable, any mode, completed course
90993	Dialysis training, patient; including helper where applicable, any mode, course not completed, per training session

1–10 of 12

1/2

FDA-listed devices for HHD (informational)mixed

NxStage System One	Device listed as 510(k) cleared for home hemodialysis
2008K home Hemodialysis Machine	Fresenius device listed as 510(k) cleared for home hemodialysis
NxStage Versie HD with GuideMe	NxStage device listed as 510(k) cleared for home hemodialysis
Tablo Hemodialysis System	Outset Medical device listed as 510(k) cleared for home hemodialysis
Quanta Dialysis System	Quanta device listed as 510(k) cleared for home hemodialysis

inv-11: Weekly standard Kt/Vurea — target value

Weekly standard Kt/Vurea threshold>= 2.1 (primary efficacy endpoint achieved in Tablo study: 99.5% in-center, 98.3% HHD measurements)

Average weekly stdKt/Vurea observedMean weekly stdKt/Vurea ~2.8 in both in-center and HHD periods in the Tablo study

Ultrafiltration delivery metricUF delivery within 10% of prescribed achieved in ~94% of treatments

inv-12: spKt/V target — target spKt/V = 1.4 per thrice-weekly session; minimum delivered spKt/V = 1.2

Target single-pool Kt/V (spKt/V)Target spKt/V = 1.4 per hemodialysis session for thrice-weekly treatment

Minimum delivered spKt/V

Provider Actions, Prior Authorization, and Documentation

Billing Rule

Applicable codes referenced

The following procedure, supply, and diagnosis codes are provided for reference only. Listing of a code does not imply coverage. Verify plan-specific reimbursement and coding requirements before submitting claims.

Covered and relevant CPT/HCPCS codes for ESRD and home dialysis (examples): 90963, 90964, 90965, 90966, 90967, 90968, 90969, 90970, 90989, 90993, 99512, S9335
Codes listed are illustrative and not exhaustive — providers must confirm applicable codes for the service rendered and the member's benefit plan

Prior Authorization

Prior authorization: treatment prescription and adequacy

Prior authorization may be required for home hemodialysis (HHD) or for more frequent/extended hemodialysis modalities. When requesting authorization, include the prescribed treatment frequency and duration, and documentation demonstrating treatment adequacy and ultrafiltration delivery.

Background and Context

Hemodialysis is an extracorporeal renal replacement therapy that removes fluid (ultrafiltration) and small‑molecule waste by diffusion across a dialyzer. Conventional in‑center HD is typically performed three times per week for about 3–5 hours per session. Home hemodialysis offers an alternative venue using machines designed for home use, but it requires a functioning vascular access (arteriovenous fistula, graft, or catheter), appropriate patient or caregiver training, and clinical stability to ensure safe delivery of therapy.

Key Definitions

inv-26: Vascular access — types and necessity

DefinitionVascular access is necessary to provide adequate blood flow to accomplish hemodialysis treatment (AVF, AVG, or indwelling dialysis catheter)

Preferred accessArteriovenous fistulas (AVFs) are the gold standard due to far fewer complications compared with AVGs or catheters

Requirement for HHD coveragePolicy requires the individual has well-functioning vascular access to be eligible for home hemodialysis

inv-27: More frequent HD — definition (four or more times per week)

DefinitionMore frequent hemodialysis: hemodialysis performed four or more times per week as defined in systematic reviews and trials

Typical comparisonCompared with usual care defined as in-center HD three times per week with <4 hours per treatment

Policy Summary

PayerUnitedHealthcare

PolicyHome Hemodialysis (for Tennessee Only)

Policy CodePolicy CSOS7TN.M

Change TypeCoverage criteria revised

Effective DateJun 1, 2025

Next Review Date

Key ActionConfirm plan-specific authorization rules and benefit terms before proceeding with home hemodialysis without skilled care.

SourceLink

On This Page

Adverse events and harms:

More frequent or longer HD is associated with increased vascular access interventions and intradialytic complications in multiple studies; nocturnal trials reported accelerated loss of residual renal function in some participants.

Access-related harms may offset benefits and require careful monitoring.

Treatment adequacy and device safety: Device-specific studies (eg, Tablo system) reported achievement of weekly standard Kt/Vurea >= 2.1 in most measurements and high rates of prescribed ultrafiltration delivery within 10%, but sample sizes were small and generalizability is limited.

Small sample sizes and sponsor involvement can limit certainty.

Population heterogeneity: Analyses report variation in short-term adjusted mortality by sex, race/ethnicity, and region among HHD patients; socioeconomic and geographic factors may influence outcomes though adjusted long-term survival can be comparable.

Heterogeneity suggests individualized assessment for HHD candidacy.

Evidence strength and policy implication: Overall strength of evidence is low to moderate; benefits for selected patients must be balanced against increased vascular access procedures and uncertain effects on total mortality, supporting targeted coverage with explicit clinical criteria and monitoring.

Minimum delivered spKt/V = 1.2

Context of recommendationNKF/KDOQI (2015) recommendation applies to patients treated thrice weekly; consider additional sessions or longer times for specific clinical needs

Specify prescribed regimen (e.g., conventional thrice-weekly HD vs. more frequent or extended HD; number of sessions/week; hours/session)
Provide objective adequacy metrics (e.g., weekly standard Kt/Vurea) and UF delivery performance
Document trial of conventional thrice-weekly HD where clinically appropriate prior to escalation

Step Therapy

Step approach before frequent/extended HD

Before approving or continuing coverage for more frequent or longer duration HD, consider a step approach starting with conventional thrice-weekly in-center HD unless contraindicated or documented as unsuitable for the member.

Recommend documented trial of conventional thrice-weekly HD prior to authorization of frequent/extended HD, unless clinical circumstances justify direct initiation of an alternate regimen

Denial Risk

Access-related adverse events

Clinical evidence indicates an increased risk of vascular access complications with more frequent or longer HD. Track and document access-related adverse events and factor these risks into authorization decisions.

Document any history of access complications (e.g., thrombosis, infections, procedures) when requesting authorization
Frequent/extended HD may be denied or limited if vascular access risks outweigh expected benefit

Documentation Required

Treatment adequacy and UF delivery metrics

Document treatment adequacy and ultrafiltration (UF) delivery when seeking authorization or as part of ongoing coverage. Use objective targets and report performance results.

Treatment adequacy target example: weekly standard Kt/Vurea ≥ 2.1 (as used in clinical studies)
Ultrafiltration delivery: report proportion of treatments achieving UF within ±10% of prescribed UF (e.g., Plumb et al. reported 94%)
Provide serial adequacy and UF data for initial authorization and periodic reassessment

Note

Required verification of benefit terms

Benefit coverage is governed by the member's federal, state, or contractual plan terms. This policy is informational and does not replace plan-specific benefit determinations.

Verify the member’s benefit plan terms and any applicable federal or state mandates prior to authorization
In case of conflict between this policy and the member's benefit contract, the federal/state/contractual requirements prevail
Providers are responsible for confirming eligibility, benefits, and prior authorization requirements with UnitedHealthcare before delivering services

Documentation Required

Providers must ensure documentation supports clinical need and patient/caregiver capability for home hemodialysis and that training (or reason it could not be completed) is recorded when requesting home-based services.

Include documentation of dialysis training completion (CPT 90989) or training sessions (CPT 90993) and assessment of patient/caregiver competency
If skilled assistance is required, provide rationale and documentation that the individual cannot safely perform HHD independently

Denial Risk

Benefit conflict and denial risk

Coverage decisions for more frequent or extended HD must balance potential clinical benefits against increased risks (particularly vascular access complications) and consider available evidence and device approvals.

Provide device-specific safety/efficacy data when applicable (e.g., Tablo system study outcomes) to support HHD requests
Be aware that some HHD systems used in practice may not have been evaluated in all RCT settings; supply pertinent evidence

Evidence noteSystematic review found low strength of evidence for mortality benefit of more frequent HD versus usual care

inv-28: Extended/longer HD — definition (>=4 hours per treatment or nocturnal/longer times)

DefinitionExtended/longer hemodialysis: session duration of 4 or more hours per treatment or nocturnal/longer weekly treatment times as studied in trials

ExamplesIncludes nocturnal long sessions (eg, 6–8 hours, multiple nights per week) referenced in NKF/KDOQI guidance and trial protocols

Clinical rationaleConsidered for patients needing better volume or metabolic control (large interdialytic weight gains, uncontrolled BP, hyperphosphatemia)

inv-29: Conventional hemodialysis frequency — usually 3 to 5 hours per session, 3 days per week

Typical regimenConventional hemodialysis is usually performed 3 to 5 hours per session, 3 days per week

SettingConventionally delivered in-center but may be performed at home when appropriate and trained

Clinical implicationsConventional thrice-weekly HD serves as the usual-care comparator in trials of frequent or extended HD

inv-30: spKt/V target — Target single-pool Kt/V = 1.4 per session for thrice-weekly treatment; minimum delivered spKt/V = 1.2

Target spKt/V per sessionTarget single-pool Kt/V = 1.4 per hemodialysis session for thrice-weekly treatment

Minimum delivered spKt/VMinimum delivered spKt/V = 1.2

Guideline sourceRecommendation from NKF/KDOQI (2015) hemodialysis adequacy guidelines