Compounded Medications
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Coverage criteria for compounded medications across SelectHealth Commercial, Medicare (CMS), and Community Care (Medicaid); specifies when compounded prescriptions are medically necessary and includes billing/coding and prior authorization guidance.
For Commercial Plan Policy, added four diagnostic tests to list of exclusions: RNAse L enzymatic activity assay or RNase L protein quantification; Gene expression profiling; Evaluation of mitochondrial disorders; Evaluation of enteric dysbiosis.
12/30/25: removed specialist requirement, updated list of conservative therapies, removed requirement concerning total knee replacement, removed requirement concerning chart notes being required, and clarified requirements in criterion #4d regarding intra-articular steroid injection timing and limits.
2/4/25: added SynoJoynt as an eligible viscosupplementation treatment option when criteria are met.
2/8/24: added new coverage criterion requiring failure of one preferred viscosupplement (Synvisc, Synvisc-One, or Euflexxa); noted that these preferred agents do not require prior authorization when administered for osteoarthritis of the knee.
10/12/23: removed previous criterion that required only certain providers administer this treatment.
Coverage Criteria
Medically Necessary Compounded Prescriptions
A compounded prescription is considered medically necessary when ALL of the following are met:
All conditions must be met for medical necessity.
Documentation must justify why commercially available product is unsuitable.
Covered diagnostic tests
Covered diagnostic tests for evaluation of suspected CFS when clinically indicated
Not medically necessary / investigational
Tests considered investigational and not covered for evaluation of CFS
Estradiol pellets (Commercial plan)
Commercial plan stance on estradiol pellet therapy
Commercial plan policy: not covered.
Lyme disease — IV antibiotic use
Lyme disease antibiotic coverage stance
Repeat or prolonged IV antibiotic therapy considered not medically necessary.
Medically necessary IV antibiotic therapy (up to 4 weeks)
Covered when ALL of the following are met:
All three core requirements must be satisfied.
One qualifying manifestation required in addition to core requirements.
Initial Therapy
Covered when ALL of the following are met
Patients outside this range considered case-by-case if otherwise eligible.
Not eligible for grade I or IV.
Functional impairment must be documented.
All listed conservative therapies must have been tried unless contraindicated.
Documentation of failure required for non-preferred agents.
Per-product quantity limits and course schedules apply.
Continuation and Quantity Limits
Limits and continuation rules
Applies to repeat courses.
Full list of product limits provided in the policy.
Initial therapy (medical necessity)
Covered when ALL of the following are met
Evidence (systematic reviews and RCTs) supports modest symptomatic benefit for HA in responders.
Continuation/repeat therapy
Covered when ALL of the following are met
Routine repeat treatments without documented prior response or outside per-product recommended intervals are not supported.
Updated Commercial Plan Coverage Criteria (summary)
Commercial Plan coverage updated over time; select material changes include:
These are material revisions recorded in the policy revision history.
Select Health does NOT cover compounded bio-identical hormone replacement therapy (BHRT). The policy states that compounded BHRT safety and efficacy have not been documented in clinical studies and that BHRT prescriptions are uniquely formulated; therefore coverage for these compounds is not provided under the Commercial Plan criteria.
As noted in the policy, compounded prescriptions are only covered when they meet all specified requirements (e.g., include at least one FDA-approved legend medication, contain therapeutic amounts, and have safety/effectiveness supported by literature); BHRT products do not meet these criteria and are explicitly excluded.
Drug compounding that is performed solely for convenience or nonmedical reasons is considered not medically necessary. The policy explains that compounding may be appropriate when a commercially available product does not meet a patient’s clinical needs (for example, unavailable strength, dosage form, or excipient allergy), but routine convenience-based compounding is not covered.
When a compound is similar to a commercially available product but differs only in dosage, form, or absence of nontherapeutic ingredients (e.g., dye, sweetener, preservative), the prescriber must provide clinical documentation justifying the medical need for the compound; absent such justification, coverage may be denied.
Select Health does not cover diagnostic tests for evaluation of chronic fatigue syndrome (CFS) that the policy lists as investigational. Examples include ELISA/ACT testing, evaluation of enteric dysbiosis, evaluation of mitochondrial disorders, functional elevation of NK cells, gene expression profiling, radionuclide scans (SPECT, PET), RNase L assays, serologic tests for Candida, viral serologies (except HIV), and several other specialized immune or molecular tests.
Requests for these listed investigational tests submitted for routine evaluation of CFS will be denied because the policy considers them to lack sufficient evidence of diagnostic utility for confirming or excluding CFS.
Revision history documents that on 2/21/23 the Commercial Plan Policy explicitly added four diagnostic tests to the list of exclusions for CFS: RNase L enzymatic activity assay or RNase L protein quantification; gene expression profiling; evaluation of mitochondrial disorders; and evaluation of enteric dysbiosis.
Use of these newly listed tests as part of routine evaluation for CFS may therefore trigger denial under the Commercial Plan policy effective from that revision.
Select Health limits acceptable intravenous (IV) antibiotic agents for Lyme disease coverage to specified drugs: ceftriaxone, cefotaxime, or penicillin G, with azithromycin as an option for patients with beta-lactam allergy. Use of other IV agents (for example carbapenems, first‑generation cephalosporins, fluoroquinolones, or fluconazole) is considered investigational and is not covered.
The policy also clarifies that IV antibiotic therapy is appropriate only in defined clinical situations (e.g., Lyme arthritis, carditis, objective neurologic complications) and that use of nonlisted IV agents or indications outside the coverage criteria will not be authorized.
Home healthcare services related to the administration of IV therapy that is not covered (for example nursing visits to administer noncovered antibiotics, maintenance of central venous catheters, or home care supplies) are themselves not covered. If the IV antibiotic therapy is not authorized, associated home infusion services and supplies will also be denied.
Viscosupplementation is covered only for the knee. The policy states that viscosupplementation for any joint other than the knee (including TMJ, shoulder, elbow, wrist, hip, and ankle) is considered investigational/experimental and therefore not covered.
Knee viscosupplementation coverage requires meeting the policy’s knee-specific eligibility and diagnostic criteria and does not extend to other joints.
Available comparative evidence does not establish clear superiority of high‑molecular‑weight (HMW) versus low‑molecular‑weight (LMW) hyaluronan products. Systematic reviews and meta-analyses report a modest overall benefit of HA injections versus placebo, but heterogeneity among studies limits definitive conclusions about class-wide superiority.
Individual randomized trials have produced mixed results, and the policy summarizes that relative effectiveness within the HA class cannot be conclusively determined; product selection should therefore follow the policy’s per-product evidence, dosing limits, and documented clinical response rather than an assumption of HMW superiority.
The revision history records multiple material changes over time, including removal of some prior requirements and exclusions (for example, removal of the specialist-only administration requirement and of certain prior chart-note requirements) and addition of new requirements such as failure of a preferred viscosupplement prior to coverage of non‑preferred agents.
These changes indicate that certain previous exclusionary or administrative requirements have been eliminated from the current Commercial Plan criteria; providers should consult the current policy text and revision log for details when preparing authorization requests.
Reiterating policy intent, compounding for convenience is explicitly described as not medically necessary. The policy distinguishes clinically justified compounding (e.g., lack of commercially available strength, excipient allergy) from convenience compounding and will deny coverage for the latter.
When convenience-driven compounding is proposed, documentation demonstrating a medical need is required to support any coverage consideration; absent such documentation, claims are subject to denial.
The policy states that the investigational diagnostic tests listed do not confirm or exclude chronic fatigue syndrome (CFS) and are considered not medically necessary for routine evaluation. The IOM-referenced diagnostic threshold guidance is also cited elsewhere in the policy to support use of only clinically indicated, evidence-based testing.
Because these investigational tests lack validated diagnostic utility for CFS, their use for routine evaluation should not be expected to be covered under the policy.
Implantable estradiol pellets (compounded subcutaneous 17 beta‑estradiol pellets) are considered experimental/investigational and are not covered for commercial members. The policy cites the absence of FDA‑approved formulations, unpredictable serum release rates, concerns about reversibility and dosing, and safety risks such as bleeding and infection as reasons for noncoverage.
Given these unresolved safety and pharmacokinetic concerns, implantation of estradiol pellets for menopausal or hormonal indications is excluded from coverage.
For Lyme disease, the policy considers repeat or prolonged IV antibiotic therapy beyond 4 weeks to be not medically necessary. Systematic evidence and randomized trials have not shown benefit for extended antibiotic courses and have demonstrated increased risk of harm, which informs the policy’s limitation on IV antibiotic duration.
Thus, requests for extended (>4 weeks) or repeated IV antibiotic courses for Lyme disease will generally be denied unless they meet the limited, policy-defined exceptions.
The policy enumerates an expanded list of Lyme disease clinical scenarios considered not medically necessary, including prophylactic treatment after a tick bite without clinical findings, treatment of chronic fatigue/fibromyalgia attributed to Lyme, initial treatment of Lyme arthritis without neurologic symptoms, antibiotic-refractory Lyme arthritis after specified prior courses, use of intramuscular antibiotics for Lyme disease, and use of non‑recommended IV agents or investigational tests to justify continued IV therapy.
Providers must document laboratory-confirmed Lyme disease and qualifying clinical manifestations per the policy to support authorization; many other clinical scenarios are excluded from coverage.
The policy requires radiographic confirmation of knee osteoarthritis with radiologic grade II or III (moderate disease) for eligibility; patients with grade I (mild) or grade IV (severe) disease are listed as not eligible for viscosupplementation coverage.
Functional impairment must also be at least moderate. These radiographic and functional thresholds are enforced when evaluating coverage requests for knee viscosupplementation.
Routine repeat viscosupplementation without prior documented response or outside the per-product recommended course/dosing is not supported. The policy requires documentation of prior symptomatic improvement following an initial course and adherence to per-product injection counts and interval recommendations for repeat treatments.
The revision history further clarifies operational updates (for example, preferred-agent sequencing and product additions), but the core requirement remains that repeat treatments be justified by prior documented benefit and conform to product-specific schedules.
The revision history shows that some prior explicit 'not medically necessary' statements or administrative requirements were removed or revised across updates (for example, removal of the specialist-only administration requirement and elimination of a chart‑notes requirement). The chunks provided here do not contain every previous NMN statement; therefore, absence of a specific NMN phrase in these chunks does not imply that a given scenario is covered.
Providers should consult the full, current policy and revision log for precise current NMN language and for operational details that affect authorization decisions.
Coding
| No specific CPT codes identified |
| J7999 | Compounded drug, not otherwise classified |
| 70551 | Magnetic resonance imaging, brain; without contrast material |
| 70552 | Magnetic resonance imaging, brain; with contrast material(s) |
| 70553 | Magnetic resonance imaging, brain; without contrast, followed by contrast and further sequences |
| 80048 | Basic metabolic panel (calcium, total) |
| 80050 | General health panel |
| 80051 | Electrolytes panel |
| 81000 | Urinalysis, dip stick or tablet reagent; non-automated, with microscopy |
| 81001 | Urinalysis, automated with microscopy |
| 81002 | Urinalysis, non-automated, without microscopy |
| 81003 | Urinalysis, automated, without microscopy |
| J0456 | Injection, azithromycin, 500 mg |
| J0696 | Injection, ceftriaxone sodium, per 250 mg |
| J0698 | Injection, cefotaxime sodium, per gm |
| J2540 | Injection, penicillin G potassium, up to 600,000 units [IV] |
| S9494 | Home infusion therapy, antibiotic, antiviral, or antifungal therapy; per diem |
| S9497 | Home infusion therapy; once every 3 hours; per diem |
| S9500 | Home infusion therapy; once every 24 hours |
| S9501 | Home infusion therapy; once every 12 hours |
| S9502 | Home infusion therapy; once every 8 hours |
| S9503 | Home infusion therapy; once every 6 hours |
| J3490 | Unclassified drug |
| J7318 | Hyaluronan or derivative, Durolane, for intra-articular injection, 1 mg |
| J7320 | Hyaluronan or derivative, GenVisc 850, for intra-articular injection, 1 mg |
| J7321 | Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose |
| J7322 | Hyaluronan or derivative, Hymovis, for intra-articular injection, 1 mg |
| J7323 | Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose |
| J7324 | Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose |
| J7325 | Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg |
| J7326 | Hyaluronan or derivative, gel-one, for intra-articular injection, per dose |
| J7327 | Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose |
Provider Actions & Requirements
Medicare & Program-Specific Coverage
Medicare and other program-specific coverage determinations take precedence where applicable. For Medicare members, follow CMS/NCD/LCD decisions; if CMS has not adopted a determination and InterQual criteria are unavailable, the SelectHealth Commercial policy applies. For Select Health Community Care (Medicaid), policies typically align with Utah Medicaid (including InterQual); NCD/LCD or SelectHealth Commercial criteria may be used in some situations.
- Medicare: follow CMS coverage determinations first; if absent and InterQual unavailable, apply SelectHealth Commercial policy.
- Community Care (Medicaid): align with State of Utah Medicaid and InterQual; may defer to NCD/LCD or SelectHealth Commercial when applicable.
Prior Authorization Requirements
Prior authorization (PA) is required for certain products and services and coverage is limited to the criteria listed in the applicable policy. Preferred viscosupplement agents (Synvisc, Synvisc‑One, Euflexxa) do not require prior authorization when administered for osteoarthritis of the knee. Non-preferred or variant commercial products and many IV antibiotic courses require PA and supporting documentation.
- Preferred viscosupplements (Synvisc, Synvisc‑One, Euflexxa): no PA required for knee OA when criteria met.
- Non-preferred hyaluronan products and J3490 billed hyaluronans: PA required; submit clinical documentation per product-specific schedules and quantity limits.
- IV antibiotics for Lyme disease: PA required; coverage limited to specified clinical criteria and duration (typically ≤4 weeks).
Prescriber Clinical Justification & Step Requirements
Prescribers must provide clinical justification when requesting compounded medications that differ from available commercial products (differences in dosage, dosage form, or omission of excipients). For variant commercial products or non‑preferred agents, the prescriber should document why the preferred agent is not appropriate or has failed.
- Clinical justification required when a compound or commercial variant differs from an FDA‑approved product (dose, form, excipient changes).
- For viscosupplementation beyond preferred agents, document failure of one preferred agent (Commercial plan) before approving non‑preferred products.
Investigational / Excluded Diagnostic Tests — Denial Risk
Be aware of specific investigational or excluded diagnostic tests and that use of these tests may trigger claim denials. Requests for tests listed as investigational/denied should be expected to be denied unless compelling, documented rationale is provided and falls within limited exceptions.
- Denied/excluded diagnostic tests for CFS include: RNAse L enzymatic activity assay or RNase L protein quantification; Gene expression profiling; Evaluation of mitochondrial disorders; Evaluation of enteric dysbiosis; and others listed in the CFS diagnostic testing policy.
- Use of excluded Lyme tests (e.g., PCR-based urine detection, genotyping/phenotyping, C6 peptide ELISA, CXCL13, direct probe/quantification techniques) is considered experimental/investigational and may be denied.
Documentation & Benefit Applicability
Document the clinical indication and relevant benefit information with all PA requests. Provide symptom history, prior treatments tried and outcomes, and applicable member benefit details. For Lyme disease IV therapy, include laboratory confirmation and involvement/diagnosis by a board‑certified infectious disease specialist when required.
- Include clinical indication, duration of symptoms, prior conservative therapies and responses, and member benefit/plan info with requests.
- Lyme IV antibiotics: provide lab-confirmed diagnosis and documentation that a board‑certified infectious disease specialist established the diagnosis when required.
- Viscosupplementation: include radiographic confirmation and radiologic grade II/III documentation and evidence of failure of conservative therapies; follow per-product quantity/course limits.
Quantity, Course Limits & Documentation Expectations
Follow published product quantity and course limits and reauthorization requirements. Failure to document required prior steps or preferred‑agent failure may lead to denial. Chart note requirements were removed in later revisions, but adhere to current criteria and documentation expectations.
- Adhere to per-product injection counts and course schedules (e.g., Euflexxa = 3 injections/course; Synvisc = 3 injections; Durolane = 1 injection).
- Subsequent viscosupplementation injections require reauthorization every 6 months.
- Not documenting failure of required conservative therapy or of one preferred viscosupplement (Commercial) is a common denial trigger.
Coverage, Contact & Provider Actions
For questions about member benefits or policy interpretation, contact SelectHealth Provider Relations or Member Customer Service. Always verify member eligibility and specific benefit coverage prior to submitting authorization requests.
- Members: call the phone number on the member ID card for benefit questions.
- Providers: contact SelectHealth Provider Relations at (801) 442‑3692 for policy or PA questions.
- Verify member-specific benefit coverage and plan type (Commercial, Medicare, Community Care) before proceeding.
Step Therapy & Placement After Conservative Treatment
Step‑therapy placement: viscosupplementation is considered after failure of conservative therapies (weight loss/activity modification, physical therapy, prescription NSAIDs, and intra‑articular steroid—limit 2 injections). For Lyme disease, oral therapy is preferred; IV therapy is reserved for specified cardiac, neurologic, or oral‑therapy‑failure situations.
- Viscosupplementation considered only after documented failure/intolerance of listed conservative measures.
- Lyme disease: reserve IV antibiotics for myocarditis with conduction block, persistent/recurrent arthritis after oral therapy, or neurologic involvement, or when oral therapy fails or is not tolerated.
Background
Drug compounding is defined in the policy as the preparation, mixing, or alteration of medications by a pharmacist or physician to meet an individual patient’s needs; it may be appropriate when commercial products are unavailable in required strengths or forms or when patients have allergies to excipients.
However, the policy emphasizes that compounding must address a documented medical need to be considered for coverage; routine compounding for convenience is explicitly not covered.
Definitions
Initial Therapy Criteria
Guideline-based initial therapy
Preferred initial therapy and durations per clinical guidelines
Select Health aligns coverage with guideline indications for IV use.
Initial Therapy Requirements
Initial coverage requirements
Initial Therapy
Initial course coverage
Evidence reviews report modest benefit for HA versus placebo; single-course treatment supported when prior therapies failed.
Preferred-agent initial therapy
Preferred-agent sequencing and authorization notes from revision history.
Derived from the 2/8/24 and 2/4/25 revision history entries.
Continuation Criteria
Continuation Therapy
Reauthorization and product-specific courses
Continuation therapy
Repeat treatment permitted when prior response documented and timing consistent with product evidence
Evidence for repeat treatment safety/effectiveness is limited; Synvisc may have higher local inflammatory reactions.
Step Therapy
| Step | Requirement | Notes |
|---|---|---|
| 1 | IV therapy may be authorized when oral therapy has failed or is not tolerated and qualifying clinical criteria are met | Qualifying manifestations include myocarditis with advanced AV block; persistent/recurrent arthritis after a 1-month trial of oral antibiotics; or acute/chronic CNS or PNS neurologic disease (e.g., meningitis, CSF pleocytosis, severe peripheral neuropathy). Documentation must include laboratory-confirmed Lyme disease and specialist diagnosis. |
| Step | Requirement | Notes |
|---|---|---|
| 1 | Trial of a preferred viscosupplement required before coverage of other products | Preferred agents are Synvisc, Synvisc-One, and Euflexxa; these preferred agents do not require prior authorization for osteoarthritis of the knee. |
| Plan | Requirement | Notes |
|---|---|---|
| Commercial Plan | Must try and fail one preferred agent (Synvisc, Synvisc-One, or Euflexxa) before coverage of other viscosupplements | Requirement added in 2/8/24 revision; preferred agents are exempt from prior authorization for knee OA. Documentation of failure should follow policy conservative-therapy and product-specific criteria. |
Quantity Limits
Site of Care
Home health services for noncovered IV therapy are not covered
Home health services (nursing visits, catheter maintenance, supplies) for administration of IV therapy that is not covered are not covered and may be denied.
- Select Health does not cover home healthcare services related to noncovered IV antibiotic therapy.
Revision History
Removed specialist requirement; updated conservative therapies list; removed total knee replacement requirement; removed chart notes requirement; clarified intra-articular steroid injection timing and limits (at least 1-month trial within past 6 months; limit of 2 injections).
For the Commercial Plan, added four diagnostic tests to the exclusions list for evaluation of chronic fatigue syndrome: RNase L enzymatic activity assay or RNase L protein quantification; gene expression profiling; evaluation of mitochondrial disorders; and evaluation of enteric dysbiosis.
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