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Home Hemodialysis (HHD) — Coverage Criteria
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This policy governs coverage and medical necessity criteria for home hemodialysis (with and without skilled care) for individuals with end-stage renal disease under UnitedHealthcare Commercial and Individual Exchange plans.
Template updated in the Policy History/Revision Information.
Coverage Criteria for Home Hemodialysis
HHD without skilled care — medical necessity
Covered when ALL of the following are met:
HHD with skilled care (staff-assisted) — medical necessity
Covered when ALL of the following are met:
Evidence summaries relevant to coverage
Evidence summary relevant to coverage determinations
Findings often derive from observational data subject to residual confounding; randomized trials are smaller and show mixed results.
Effects on LV mass are plausibly mediated by improved volume and BP control.
Self-reported measures may be biased by lack of blinding and younger, healthier study populations.
Adverse event signals vary by regimen and study; small sample sizes limit inference.
Device-level evidence may inform coverage but is limited by study design and size.
Coverage for home hemodialysis requires that the patient be appropriate for treatment in the home setting. Individuals with complications or significant concomitant disease that would make home hemodialysis unsafe or unsuitable are not considered appropriate candidates until those issues are resolved. Similarly, a patient must have well‑functioning vascular access (for example, an arteriovenous fistula or other adequate access) because inadequate access or access‑related complications can increase infection and technical risk and therefore preclude safe HHD. These clinical exclusion considerations are part of the medical necessity determination and must be documented before authorizing HHD.
The policy does not list discrete procedural exclusions, but clinical trial findings warrant caution for certain nocturnal or extended regimens. In the FHN Nocturnal trial (Rocco et al.), participants randomized to nocturnal hemodialysis experienced a higher mortality signal during extended follow‑up compared with the conventional arm; the study authors recommended cautious interpretation and further investigation. This observation supports careful patient selection and individualized risk assessment for nocturnal/extended regimens rather than blanket adoption.
Guideline panels have noted that the evidence for some home long‑frequent regimens is inconclusive. The NKF/KDOQI Work Group reviewed available data and, given uncertainty about efficacy and signals for potential harm, stated that it could not make firm recommendations for home long frequent hemodialysis. This creates a cautionary context: lack of definitive guidance means clinicians and payers should weigh potential benefits against possible risks on a case‑by‑case basis.
The document does not enumerate explicit conditions labeled as "not medically necessary." However, randomized trials show mixed results: some frequent‑HD trials report improvements in surrogate and patient‑reported outcomes while others—particularly the nocturnal trial—reported adverse signals such as higher mortality and increased vascular access procedures. These mixed trial results provide context for medical necessity decisions and support individualized assessment when considering nocturnal or intensified regimens.
Procedure Codes, Devices, and Dosage Metrics
| 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 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents. |
| 90965 | End-stage renal disease (ESRD) related services for home dialysis per full month, for patients 12-19 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents. |
| 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, per day; 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, per day; for patients 2-11 years of age. |
| 90969 | End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12-19 years of age. |
| 90970 | End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; 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. |
| 2008K @ home | 2008K @ home ™ Hemodialysis Machine (Fresenius Medical Care) |
| NxStage System One | NxStage ® System One ™ (NxStage Medical, Inc.) |
| NxStage Versi | NxStage Versi ® HD with GuideMe software (NxStage Medical, Inc.) |
| Quanta | Quanta ™ Dialysis System (Quanta Dialysis Technologies, Ltd.) |
| Tablo | Tablo ® Hemodialysis System (Outset Medical, Inc.) |
Provider Actions, Documentation, and Authorization
Prior authorization may be required for HHD-related codes
Prior authorization may be required for home hemodialysis services billed with the listed ESRD, training, home-visit, and per-diem home therapy codes; coverage is contingent on meeting the policy's medical necessity criteria.
- Codes listed: 90963–90970 (ESRD home dialysis monthly/day), 90989 (dialysis training completed), 90993 (training per session, course not completed), 99512 (home visit for hemodialysis), S9335 (home therapy per diem).
- Ensure medical necessity criteria in the policy are met when requesting authorization.
Evidence elements that may be requested
Be prepared to provide device- and regimen-specific efficacy and safety data during review, including trial-level outcomes and predefined endpoints reported in device studies.
- Efficacy endpoints: weekly standard Kt/Vurea (e.g., ≥ 2.1), average weekly stdKt/V, spKt/V targets/delivery.
- Ultrafiltration delivery metrics: percentage of treatments with UF delivered within 10% of prescribed UF.
- Safety endpoints: prespecified adverse events (number and relatedness), vascular access interventions, intradialytic hypotension.
- Patient-reported outcomes and trial results: time to recovery (TTR), general health status (EQ-5D), sleep quality, randomized trial composite outcomes and mortality data.
Prior authorization governed by member plan
This policy is informational and does not itself prescribe prior authorization codes, processes, or requirements; verify prior authorization rules with the member's specific benefit plan and any applicable tools UnitedHealthcare may use.
- Member-specific benefit plan governs in the event of conflict with this policy.
- UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administering benefits.
Document clinical justification aligned to policy criteria
When initiating or changing to HHD, document clinical justification that aligns with policy criteria and the member's plan, including stability on dialysis, training status, vascular access function, and any medical contraindications to in-center dialysis.
- State whether HHD is being requested with or without skilled care and reference the corresponding medical necessity criteria.
- Record consideration of member-specific benefit plan terms and applicable federal/state mandates.
No step therapy specified
No step therapy mandates are specified in this policy.
- Providers should still verify member-specific plan rules for any plan-level step therapy requirements.
Minimum documentation expectations
Maintain documentation that supports the member meets minimum policy expectations for HHD initiation or continuation.
- Evidence of clinical stability on dialysis (notes showing no need for skilled interventions during treatments).
- Training records: CPT 90989 for completed dialysis training course or CPT 90993 per training session if course incomplete.
- Confirmation of well-functioning vascular access documented in clinical notes.
- If staff-assisted HHD is requested, documentation of medical contraindications to leaving home and rationale for skilled care.
Suggested documentation elements from device study
From device studies, document predefined safety and efficacy endpoints that support home use of a specific HHD system.
- Weekly standard Kt/Vurea results (e.g., proportion of measurements ≥ 2.1 and mean weekly stdKt/V).
- Ultrafiltration delivery performance (e.g., percent of treatments with UF within 10% of prescribed UF).
- Number and description of prespecified adverse events and assessment of relatedness to the device.
- Patient-reported outcomes: time to recovery (TTR), EQ-5D general health scores, sleep quality measures.
- Study context: sample size, duration, and participant age distribution to assess generalizability.
Document plan-specific verification
Verify and document review of the member-specific benefit plan and any applicable federal or state mandates before applying this policy to a coverage decision.
- Record the member-specific plan document reference and note any applicable mandates or exceptions.
- If conflicts exist between this policy and the member's plan, the member-specific benefit plan governs—document how the conflict was resolved.
Denial triggers for HHD coverage
Coverage may be denied if the member does not meet the policy's medical necessity criteria or if safety concerns exist for home therapy.
- Not stable on dialysis or requires skilled care interventions during treatments.
- Individual or caregiver lacks ability or training to perform and maintain HHD.
- Presence of complications or significant concomitant disease that make HHD unsafe or unsuitable.
- Lack of well-functioning vascular access.
Study limitations that may affect coverage
Study limitations may affect extrapolation of safety and efficacy to broader populations and could influence coverage decisions.
- Small sample sizes and brief study periods limit confidence in long-term outcomes.
- Participants in device studies were on average younger than typical U.S. dialysis populations, reducing generalizability.
Reference member-specific benefits
Always reference the member-specific benefit plan document and applicable federal or state mandates when determining coverage; in the event of a conflict, the member-specific plan governs.
- Document the benefit plan used to make the decision and note any deviations from this policy based on plan terms.
- Check for Medicare NCDs/LCDs or other applicable coverage guidance when relevant (Medicare MA applicability noted).
Background — Hemodialysis and Home Therapies
Hemodialysis (HD) is an extracorporeal renal replacement therapy that removes fluid and small‑molecule waste products by circulating blood through a dialyzer. Conventional in‑center HD is typically delivered three times per week for about 3–4 hours per session. Home hemodialysis (HHD) permits delivery of dialysis in the patient’s residence using home‑capable machines and requires patient and/or caregiver training, adequate home setup, and reliable vascular access; HHD prescriptions may vary in frequency and duration but must be individualized by the treating nephrologist.
Definitions and Key Terms
Policy Revision History
Template update to the Policy History/Revision Information; no clinical coverage changes stated.
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