ModifiedUnitedHealthcarePolicy CSOS7PA.M

Home Hemodialysis (for Pennsylvania Only) - Coverage Criteria

Clinical policy governing coverage and medical necessity criteria for home hemodialysis (with and without skilled care) for Pennsylvania UnitedHealthcare members with end-stage renal disease.

Policy Summary

PayerUnitedHealthcare

PolicyHome Hemodialysis (for Pennsylvania Only)

Policy CodePolicy CSOS7PA.M

Change TypeCriteria revision and supporting information refresh

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests in Pennsylvania that document the patient meets all medical necessity criteria for home hemodialysis before coverage is approved.

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.

Supporting Information updated: Description of Services, Clinical Evidence, FDA, and References sections refreshed to reflect current information.

Archived previous policy version CSOS7PAL.

2025-06-01policy revision date

3-4 hrstypical session length

3x/wktypical frequency

Low–Very Low

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12procedure codes listed

Coverage Criteria for Home Hemodialysis

inv-01: Home hemodialysis without skilled care (Medically Necessary)

Covered when ALL of the following are met:

Home hemodialysis without skilled care - criteria: Individual undergoing hemodialysis or a non-professional caregiver has the ability to perform and maintain home hemodialysis and has received comprehensive training regarding proper protocol

Training and competency should be documented in the medical record; see applicable training codes (e.g., 90989, 90993).

Home hemodialysis without skilled care - criteria: Individual is stable on dialysis with no evidence that skilled care interventions are necessary during treatments

Stability should be assessed by the attending nephrologist and documented in the record.

Home hemodialysis without skilled care - criteria: Absence of complications and significant concomitant disease that would render home hemodialysis unsafe or unsuitable

Clinical contraindications to home therapy should be clearly documented.

Home hemodialysis without skilled care - criteria: Individual has well-functioning vascular access

Vascular access status should be documented and appropriate for home treatments.

inv-02: Staff-assisted Home Hemodialysis (Medically Necessary)

Covered when ALL of the following are met:

Staff-assisted Home Hemodialysis - criteria: Individual undergoing hemodialysis or non-professional caregiver is not capable of performing home hemodialysis

A need for staff assistance should be documented with reasons why non-skilled caregiver support is insufficient.

Staff-assisted Home Hemodialysis - criteria: Individual is stable on dialysis and not at increased risk as a result of having the procedure performed outside a dialysis center

Stability assessment and risk considerations should be documented by the attending nephrologist.

Staff-assisted Home Hemodialysis - criteria: Individual has medical contraindications to leaving home for hemodialysis

Clinical contraindications (e.g., mobility, transportation, comorbidities) should be specified in the record.

inv-03: Coverage considerations for frequent/long or home hemodialysis

Evidence-based considerations for more frequent or nocturnal hemodialysis:

Benefit evidence: Frequent in-center hemodialysis (e.g., six times per week) demonstrated improvements in composite outcomes (death or change in left ventricular mass; death or change in physical health) and secondary outcomes such as reduced LV mass and improved blood pressure in the FHN Daily Trial; frequent HD also reduced antihypertensive medication use and recovery time after dialysis

Chertow et al., FHN Daily Trial; Kotanko et al.

Harms and limitations: Frequent or nocturnal hemodialysis was associated with increased vascular access interventions and more intradialytic hypotensive events; the FHN Nocturnal Trial did not show significant benefit for co-primary outcomes and in extended follow-up higher mortality was observed in the nocturnal arm

Rocco et al., FHN Nocturnal Trial; Chertow et al.

Evidence quality and applicability: Overall strength of evidence across systematic reviews is low to very low for many outcomes; many trials enrolled younger, healthier participants and may not generalize to typical U.S. dialysis populations or to all home HD systems

inv-04: Device and modality evidence relevant to coverage

Device- and modality-specific evidence relevant to coverage decisions:

Tablo system evidence: A prospective multicenter study of the Tablo Hemodialysis System in 30 participants demonstrated high rates of achieving weekly standard Kt/Vurea targets and ultrafiltration delivery with no adverse events attributed to the device, supporting safety and efficacy for in-center and home use in the studied population

Plumb et al., 2020; Chertow et al., Tablo studies

Comparative survival evidence: Observational cohort studies reported mixed findings: some reported improved long-term survival for patients initiating HHD compared with in-center HD or PD, while others found similar early survival between modalities; these results are limited by observational design

Rydell et al.; Choi et al.; Kasza et al.

inv-05: Coverage Rationale (summary)

Summary of coverage rationale for the updated policy:

Updated coverage statement: Coverage criteria have been updated to allow home hemodialysis without skilled care as an alternative to facility-based hemodialysis for individuals with end-stage renal disease who meet the specified eligibility elements

The policy replacement clarified the vascular access wording to 'individual has well-functioning vascular access' and refreshed supporting information; full criteria details are documented in the policy. Providers should follow applicable plan prior authorization requirements.

This policy applies only to the state of Pennsylvania. Requests for services that do not meet the criteria set forth in this policy will be evaluated on a case-by-case basis according to Pennsylvania exceptions (Refer to Pennsylvania Exceptions_Pennsylvania Code_Title 55_Chapter 1101).

No explicit exclusions are listed in the provided clinical evidence excerpts for this policy. Where exclusions would affect coverage, determinations should rely on the full policy, applicable benefit plan terms, and any state-specific rules.

The previously active policy version CSOS7PAL has been archived; the current policy revision replaces and supersedes that prior version.

Systematic reviews identified in the evidence base found that, during short follow-up, more than thrice-weekly hemodialysis (i.e., four or more sessions per week) and extended-length hemodialysis did not improve clinical outcomes compared with conventional thrice-weekly dialysis and were associated with a greater number of vascular access procedures (evidence rated very low quality).

The excerpts provided do not contain an explicit blanket statement labeling services as 'not medically necessary.' Coverage determinations should follow the plan's medical necessity criteria as described in this policy and must be reconciled with applicable federal, state, or contractual benefit plan terms when making final coverage decisions.

Applicable Codes and Targets

Applicable procedure codesCPT | HCPCS

90963	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients younger than 2 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development; and counseling of parents.
90964	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 2-11 of age to include monitoring for the adequacy of nutrition, assessment f growth and development; and counseling of parents years.
90965	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 12-19 of age to include monitoring for the adequacy of nutrition, assessment of growth and development; and counseling of parents years.
90966	End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 20 of age and older years.
90967	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per for patients younger than 2 years of age day;.
90968	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per for patients 2-11 years of age day;.
90969	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per for patients 12-19 years of age day;.
90970	End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per for patients 20 years of age and older day;.
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.

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Dialysis adequacy targets

Target spKt/V per sessionRecommend a target single-pool Kt/V (spKt/V) of 1.4 per hemodialysis session for patients treated thrice weekly, with a minimum delivered spKt/V of 1.2.

ApplicabilityApplies to patients treated with thrice-weekly hemodialysis sessions as the referenced target and minimum.

Documentation expectationClinical records may be expected to document delivered spKt/V values to demonstrate adequacy of dialysis.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Plan Governance

Prior authorization: Home hemodialysis services in Pennsylvania should meet the policy's medical necessity criteria prior to coverage. Providers must follow the plan's coverage criteria and any prior authorization processes required by the member's benefit plan; requests that do not meet the policy criteria may be evaluated on a case-by-case basis.

Prior authorization required per applicable plan/benefit contract — check member-specific requirements before providing HHD.
Requests not meeting standard criteria may be reviewed case-by-case for medical necessity.
Plan contract (federal, state, or contractual benefit terms) governs in case of conflict with this policy.

Documentation Required

Documentation Requirements

Documentation must demonstrate that the individual meets all medical necessity criteria for home hemodialysis (with or without skilled care) including, but not limited to: ability of the patient or identified non‑professional caregiver to perform and maintain HHD after comprehensive training; clinical stability without skilled-care interventions required during routine treatments (unless staff-assisted HHD is requested and justified); absence of contraindicating comorbidities; and presence of well‑functioning vascular access.

Background and Evidence Summary

Hemodialysis is a form of renal replacement therapy that removes fluid and small-molecule waste using an extracorporeal circuit. Conventional in-center hemodialysis is typically performed three times per week for approximately 3–4 hours per session. Home hemodialysis (HHD) enables treatment at home using suitable devices and training and may be appropriate for selected patients who meet the policy's medical necessity criteria.

Key Definitions

Arteriovenous fistula (AVF)

DefinitionArteriovenous fistula (AVF): a vascular access created by connecting an artery to a vein.

Clinical statusConsidered the gold standard for hemodialysis access due to fewer complications compared with grafts and catheters.

Patient training notePatients and caregivers should be encouraged to learn AVF cannulation for home hemodialysis when appropriate.

Dialysis training codes

CPT 90989Dialysis training, patient; including helper where applicable, any mode, completed course.

CPT 90993Dialysis training; patient; including helper where applicable, any mode, course not completed, per training session.

Policy Revision History

2025-06-01policy_revisionLatest

Updated coverage criteria to allow home hemodialysis without skilled care as an alternative to facility-based hemodialysis; revised vascular access wording and refreshed supporting information; archived prior policy version CSOS7PAL.

Policy Summary

PayerUnitedHealthcare

PolicyHome Hemodialysis (for Pennsylvania Only)

Policy CodePolicy CSOS7PA.M

Change TypeCriteria revision and supporting information refresh

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests in Pennsylvania that document the patient meets all medical necessity criteria for home hemodialysis before coverage is approved.

SourceLink

On This Page

Staff-assisted Home Hemodialysis - criteria: Staff-assisted home hemodialysis protocols generally match those provided in the hemodialysis center (e.g., 3 times per week, 3–4 hour treatments), with exact therapy determined by the attending nephrologist

Document prescribed schedule and nephrologist rationale for staff-assisted home regimen.

Staff-assisted Home Hemodialysis - criteria: Individual has well-functioning vascular access

Vascular access status should be documented and appropriate for staff-assisted home treatments.

Shafi et al.; Mathew et al.

Document training completion (CPT 90989 or 90993 as appropriate) and competency assessments.
If caregiver will perform HHD, document caregiver identification and ability to perform required tasks.
For staff-assisted HHD, document medical contraindication to leaving home and rationale for skilled assistance.

Documentation Required

Dialysis Adequacy and Clinical Indications for Frequency/Duration Changes

Dialysis adequacy and clinical rationale for treatment frequency or duration changes must be documented. Include objective dialysis adequacy metrics (e.g., weekly standard Kt/Vurea, delivered spKt/V, ultrafiltration delivery vs prescribed UF), clinical indications for increased frequency or longer sessions, and supporting evidence from the treating nephrologist.

Report recent weekly standard Kt/Vurea and spKt/V values and target thresholds (NKF/KDOQI targets: spKt/V target 1.4 per session, minimum delivered 1.2 for thrice-weekly regimens).
Document UF delivery performance and any deviations from prescribed UF.
State clinical indications for additional sessions or longer treatment times (e.g., large interdialytic weight gains, high ultrafiltration rates, poorly controlled blood pressure, difficulty achieving dry weight, poor metabolic control such as hyperphosphatemia, metabolic acidosis, or hyperkalemia).
Note that more frequent or extended dialysis is associated with increased vascular-access procedures; document risk/benefit discussion.

Note

Modality Sequencing and Clinical Preference

Modality sequencing and preference: consider patient preference and clinical suitability when selecting HHD modalities. NKF/KDOQI suggests offering in‑center short frequent HD or home long HD for patients preferring those therapies; the attending nephrologist determines the exact dialysis therapy on an individual basis.

Consider home long hemodialysis (6–8 hours, 3–6 nights/week) for lifestyle-preference candidates.
Document residual native kidney function (Kru) monitoring if reducing dialysis dose due to significant Kru.

Step Therapy

No step therapy: there are no step therapy requirements specified in this policy. No step therapy language is present in the plan-scope instructions for home hemodialysis.

Providers should not be required to complete step-therapy sequences under this Medical Policy.
Verify member plan documents for any plan-specific utilization management controls beyond this policy.

Documentation Required

Plan Contract and Documentation Verification

Documentation and plan check: Before initiating services, providers should verify member-specific federal, state, and contractual benefit plan terms. UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administration. In the event of conflict, federal/state/contractual requirements govern coverage decisions.

Check prior authorization portals and member benefits for Pennsylvania-specific rules and requirements.
Retain all clinical records, training logs, adequacy measurements, and nephrologist orders to support coverage determinations.

Related training servicesUse these codes to report patient (or helper) dialysis training and to support documentation of training activity for HHD initiation.

More frequent or longer hemodialysis

More frequent HDDefined as four or more treatments per week in the referenced systematic review (Shafi et al., 2020).

Longer HDDefined as four or more hours per treatment in the referenced systematic review.

Evidence considerationsSystematic reviews found low-strength evidence of some physiologic benefits but increased vascular access complications; benefits must be balanced against harms.

Conventional hemodialysis

Typical scheduleConventional in-center hemodialysis is most commonly performed three times per week.

Session durationSessions typically last about 3–5 hours per treatment in-center.

Clinical roleConventional HD remains the most common treatment worldwide and is the comparator for frequent/long HD studies.

Conventional in-center hemodialysis (HD)

DefinitionConventional in-center hemodialysis (HD): standard facility-based dialysis usually performed for 3 to 5 hours per treatment on 3 days per week.

Guideline contextNKF/KDOQI and other guideline sources use conventional in-center HD as the baseline for adequacy and modality comparisons.

Patient selection notePatients should be offered modality choices (home or in-center) informed by clinical considerations and preferences.

FDA 510(k)-cleared home hemodialysis devices

Examples of 510(k)-cleared HHD devicesNxStage System One; 2008K@home Hemodialysis Machine (Fresenius); NxStage VersaHD with GuideMe; Tablo Hemodialysis System; Quanta Dialysis System.

Regulatory noteList is informational; FDA 510(k) clearance is not by itself a basis for coverage decisions.

Implication for home useThese devices have been cleared for home hemodialysis use and are cited as examples in the policy.