sierra health and life omnibus CPT Category III/T — Coverage

inv-01: Code-level coverage conclusions

Coverage conclusions by code (excerpt):

Code conclusions: Each listed CPT/HCPCS code in this excerpt is followed by a one-word conclusion; the vast majority are 'Unproven'.

See individual code entries for descriptions and conclusions.

inv-02: Omnibus codes — general coverage conclusions

Services and codes listed in the Omnibus Codes section are concluded as follows in this excerpt:

General coverage stance for listed codes: The majority of listed codes in this section are concluded 'Unproven' (not medically necessary) due to insufficient evidence.

Most omnibus codes in chunks 5–30 are marked 'Unproven'.

Exceptions noted as 'Proven/Covered in certain circumstances': A very small number of codes in the broader omnibus listing may be concluded differently (e.g., some codes noted as 'Covered in certain circumstances' or 'Proven in certain circumstances').

See specific code entries (chunk 29 G0555 noted as 'Covered in certain circumstances').

inv-03: SFDI (0061U) — Not medically necessary

SFDI (0061U) coverage rationale

SFDI not medically necessary: Transcutaneous measurement of biomarkers using spatial frequency domain imaging (SFDI) (CPT 0061U) is considered unproven and not medically necessary due to insufficient evidence of clinical utility; FDA 510(k) clearance exists for the Clarifi system but does not establish evidence of improved patient outcomes.

Supported by ECRI assessment and small observational studies (Jett, Weinkauf) showing promising measurements but no demonstrated outcome benefit.

inv-04: Extracranial vertebral artery stenting — Not medically necessary

Extracranial vertebral artery stenting (0075T/0076T) coverage rationale

VA stenting concluded unproven here: Transcatheter placement of extracranial vertebral artery stent(s) (0075T/0076T) is considered unproven and not medically necessary due to insufficient evidence of efficacy; observational registry data suggest possible benefit in PCTL when performed during EVT within 24 hours but randomized trial evidence is lacking and guideline recommendations are cautious.24 hours (contextual)

Observational pooled BASILAR+PERSIST data suggest benefit but subject to selection bias; ESVS guidance does not support routine stenting for many presentations.

inv-05: Coverage considerations and evidence synthesis

Evidence and guideline-informed coverage considerations:

Observational evidence for acute extracranial VA stenting: Registry-based pooled analyses (BASILAR + PERSIST) of EVT for posterior circulation tandem lesions show adjusted associations of extracranial VA stenting with favorable 90-day and 1-year mRS shifts and reduced mortality without increased sICH, but these are nonrandomized and subject to selection bias.

Li et al. pooled registry data (chunks 36–37).

Randomized/systematic evidence context: Systematic reviews and randomized trials (eg, VIST, Cochrane review) do not demonstrate clear advantage of endovascular therapy plus medical therapy over medical therapy alone for vertebral artery stenosis in primary endpoints; post hoc signals for extracranial lesions warrant further study.

Xu et al. Cochrane review and VIST trial summaries (chunks 39, 41).

Guideline stance (ESVS 2023): ESVS 2023 recommends against routine intervention for asymptomatic vertebral lesions and does not recommend routine stenting for vertebrobasilar TIA/stroke with 50–99% stenosis; revascularization may be considered for recurrent symptoms despite best medical therapy and drug-eluting stents are preferred when stenting is performed.

inv-06: Not Medically Necessary — Blood-based CRC biomarker panels

Blood-based biomarker panels for CRC screening (e.g., BeScreened™-CRC)

Not covered - overall conclusion: Use of a biomarker panel-based algorithmic analysis test to screen for colorectal cancer or advanced adenomas (eg, BeScreened™/0163U) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy and absence from USPSTF screening recommendations.

Policy explicitly states 0163U is 'Unproven' (chunk 54).

inv-07: Not Medically Necessary — CAD for chest radiographs

Computer-aided detection (CAD) for chest radiographs

Not covered - overall conclusion: Computer-aided detection (CAD) of chest radiographs (0174T/0175T) is unproven and not medically necessary due to insufficient evidence that CAD improves diagnostic sensitivity or patient outcomes; randomized trial data show no improvement in sensitivity or false-positive rate in ED settings.

Hwang et al. RCT found no improvement with AI-CAD (chunk 64); systematic reviews are inconclusive (chunk 65).

inv-08: Not Medically Necessary — Eyelid thermal pulsation and wearable devices

Thermal pulsation and wearable open-eye eyelid heat devices for meibomian gland evacuation/evaluation

Not covered - overall conclusion: Thermal pulsation systems (eg, LipiFlow) and wearable open-eye eyelid heat devices (eg, TearCare) for meibomian gland evacuation or evaluation are considered unproven and not medically necessary due to limitations in evidence despite some RCTs and systematic reviews reporting short-term objective and symptom improvements; overall evidence quality, risk of bias, and heterogeneity preclude routine coverage.

Multiple RCTs and meta-analyses report improvements but studies are small, manufacturer-funded, and have methodological limitations (chunks 73–77, 80–85).

inv-09: Evidence summary

Clinical evidence summaries and trial outcomes informing coverage decisions

Evidence of benefit: Randomized trials and systematic reviews report that single-session VTPT/LipiFlow or TearCare procedures can improve objective measures (eg, MGS, TBUT) and symptom scores (eg, OSDI, SPEED) in short-term follow-up, with some studies reporting benefit up to 12 months; however many trials are small, unmasked, or industry-funded and conclusions are tempered by risk of bias and heterogeneity.

Refer to multiple RCTs and meta-analyses summarized in chunks 73–77 and 80–85.

inv-10: Atherectomy — coverage determination

Atherectomy for visceral/renal/abdominal/brachiocephalic arteries is considered:

Primary stance: Transluminal peripheral atherectomy of visceral, renal, abdominal, or brachiocephalic arteries (CPT 0234T–0237T) is unproven and not medically necessary due to insufficient evidence of safety and efficacy; published evidence is limited primarily to case reports and small case series.

Policy explicitly lists these codes as 'Unproven' with limited evidence (chunks 98–99).

inv-11: PreTRM / proteomic assay — coverage determination

Proteomic biomarker test (PreTRM) for predicting spontaneous preterm birth is considered:

Primary stance: The PreTRM serum-based proteomic biomarker test (IBP4/SHBG; reported via unlisted multianalyte code when applicable) for screening asymptomatic pregnant individuals to predict spontaneous preterm birth risk is unproven and not medically necessary due to insufficient evidence that screening and subsequent interventions improve clinical outcomes.

Clinical trials (TREETOP, Saade, Branch) and guideline assessments summarized show predictive signals but lack evidence of improved outcomes from screening-based management (chunks 101–108).

inv-12: Mobile / automated audiometry — clinical evidence

Mobile / automated audiometry — evidence summary (informational; no explicit coverage decision in this section):

Key findings: Mobile and automated audiometry systems demonstrate promising accuracy in many studies and meta-analyses (pooled sensitivity/specificity often high), and may be useful where conventional audiometry is unavailable; limitations include heterogeneity, variable accuracy in children and older adults, dependence on testing conditions and devices, and remaining questions about replacing standard pure-tone audiometry.

Systematic reviews and meta-analyses summarized in chunks 90–96 show overall favorable but heterogeneous results.

inv-13: Not Medically Necessary / Unproven

Coverage stance in cited text

Not medically necessary statements: Tear film imaging to monitor or assess tear film disorders and myocardial sympathetic innervation imaging with 123I‑MIBG for prognostic assessment in heart failure are described as unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Explicit statements in chunks 110 and 119.

inv-14: 123I‑MIBG imaging — prognostic evidence

Imaging prognostic use summarized; no coverage rules explicitly stated in this portion — evidence notes association but not demonstrated clinical benefit from imaging-guided decisions.

Prognostic association: 123I‑MIBG planar/SPECT imaging metrics (eg, heart-to-mediastinum [H/M] ratio, SPECT total defect score) are associated with risk stratification in heart failure cohorts (eg, ADMIRE-HF H/M <1.60 linked to higher mortality), but evidence does not demonstrate that imaging-guided management improves clinical outcomes; thus routine prognostic use is unproven.H/M < 1.60 associated with higher risk

ADMIRE-HF follow-up and other observational studies summarized (chunks 126–127).

inv-15: Automated VEPs — screening and diagnostic context

Automated and pattern VEPs — evidence and screening recommendations

VEP screening stance: Automated visual evoked potentials (VEPs) for population-based visual acuity screening are unproven and not medically necessary due to insufficient evidence; VEPs may have diagnostic or prognostic value as an objective acuity estimator in selected patients (eg, preverbal children or individuals with developmental impairments) when used with age‑stratified reference data.

Policy summarizes guideline and systematic review findings (chunks 129–131).

inv-16: Sinus tarsi implant — not medically necessary / unproven

Subtalar arthroereisis / sinus tarsi implant — coverage stance from evidence synthesis

Coverage stance for sinus tarsi implant: Use of a sinus tarsi implant (subtalar arthroereisis; CPT 0335T and related codes) is unproven and not medically necessary for any indication due to insufficient, low-quality evidence, heterogeneous outcomes, and substantial implant-related complication/removal rates reported in systematic reviews and case series.

Multiple systematic reviews and HTAs report limited, low-quality evidence and high implant removal rates (chunks 137–145).

inv-17: Subtalar arthroereisis — evidence and selection

Evidence-based stance and patient selection considerations from assessments and specialty guidance

Subtalar arthroereisis evidence: Existing evidence is low quality and heterogeneous; professional guidance recommends against use of subtalar implant as sole corrective procedure for certain adult AAFD stages and suggests limited use with special clinical governance or as adjunct to soft-tissue procedures; patient selection and informed consent are important when considered.

ACFAS consensus and NICE guidance cited; systematic reviews note implant removal rates and need for higher-quality studies (chunks 145–148).

inv-18: Renal denervation — coverage considerations

Renal denervation indications and evidence summary

RDN candidate selection: Candidate selection typically requires documented resistant or uncontrolled hypertension despite optimized lifestyle and pharmacologic therapy; RDN is considered an adjunct in selected patients after medication optimization and shared decision-making.resistant HTN = BP >130/80 on 3 meds

Regulatory approvals noted for specific systems; guidance recommends optimization before RDN (chunks 154–156, 159).

RDN efficacy evidence: Randomized sham-controlled trials and meta-analyses demonstrate modest short-term reductions in ambulatory and office systolic blood pressure for some devices (eg, RADIANCE II, SPYRAL series), with heterogeneity across trials and limited data on long-term clinical outcomes; additional high-quality studies are needed to confirm durability and effect on clinical endpoints.mean BP reductions ~4-6 mm Hg in pooled analyses

Systematic reviews and RCTs summarized (chunks 154–159, 166–169).

inv-19: Coverage summaries

Summary of coverage stance and evidence

RSA_not_covered: Radiostereometric analysis (RSA; CPT 0347T–0350T) is unproven and not medically necessary for routine clinical indications; although precise for research monitoring of implant micromotion, routine clinical benefit and effect on outcomes are not established.

RSA is used in research but lacks evidence for routine clinical utility (chunks 174–175, 179).

BIA_not_covered: Bioelectrical impedance analysis whole body composition assessment (CPT 0358T) is unproven and not medically necessary due to inconsistent accuracy, variability with hydration and obesity, and limited evidence of clinical utility.

Multiple systematic reviews and ECRI assessments summarized (chunks 180–186).

RDN_evidence_context: Renal denervation shows modest BP reductions in randomized trials and meta-analyses but limited evidence on clinical outcomes and long-term durability; some devices have FDA approvals as adjuncts in specific settings and candidate selection and documentation expectations apply.

See RDN evidence and approvals (chunks 154–159, 166–169).

inv-20: BIA — Not medically necessary

Bioelectrical impedance analysis (BIA) whole body composition assessment

Primary stance: BIA whole body composition assessment (0358T) is unproven and not medically necessary due to inconsistent accuracy across populations, sensitivity to hydration status, lack of standardization, and limited evidence linking results to improved clinical outcomes.

Systematic reviews and trials highlight variability and methodological concerns (chunks 180–186).

inv-21: Electronic brachytherapy — Not medically necessary / Limited use

High dose rate electronic brachytherapy (0395T)

Primary stance: High dose rate electronic brachytherapy (0395T) is unproven and not medically necessary for routine treatment of indications such as breast APBI, nonmelanoma skin cancer, and gynecologic cancers outside clinical trials or registries due to limited, low-quality evidence and concerns about comparative efficacy and dosimetry.

Professional society statements (ABS, AAD, NCCN) and ECRI assessments cited (chunks 189–194, 197–198).

inv-22: Coverage considerations

Coverage stance and clinical guidance:

Not medically necessary statement: Confocal laser endomicroscopy (CLE/pCLE) is judged unproven and not medically necessary for routine use due to insufficient evidence of safety and efficacy across multiple GI and pancreatobiliary indications.

Policy summary states CLE is unproven (chunk 202) though evidence shows diagnostic promise in select settings (chunks 209–216).

Adjunctive use in expert centers: CLE/pCLE may be considered as an adjunct in expert centers to target biopsies or evaluate indeterminate biliary strictures given favorable pooled sensitivity/specificity in meta-analyses, but data are primarily from specialized centers and do not support routine replacement of established biopsy protocols.

Meta-analyses and guideline updates summarized (chunks 209–216).

inv-23: Not Medically Necessary / Unproven Interventions

Coverage stance statements from the document

CCM coverage stance: Cardiac contractility modulation (CCM) implantable device therapy is described as unproven and not medically necessary for treating chronic heart failure due to insufficient high-quality evidence of safety and efficacy.

Policy explicitly lists CCM as unproven/not medically necessary (chunk 223).

Percutaneous cryoablation for chronic pain coverage stance: Percutaneous cryoablation/cryoneurolysis of peripheral nerves or plexuses for chronic pain is unproven and not medically necessary due to limited and conflicting evidence.

Policy states percutaneous cryoablation codes are unproven (chunk 233).

inv-24: Cryoneurolysis / iovera — evidence synthesis

Evidence summary regarding cryoneurolysis/iovera for knee OA and related pain:

Evidence characterization: Available randomized and nonrandomized studies of cryoneurolysis/iovera for knee OA and related indications show mixed results with methodological limitations; short-term pain reductions are reported in some sham-controlled trials but benefits may diminish over time and evidence quality is limited.

ECRI and Hayes assessments summarize conflicting results and need for larger high-quality trials (chunks 234, 237, 238).

inv-25: Other indications — limited evidence

Evidence for other indications (occipital neuralgia, phantom limb pain):

Small uncontrolled studies: Pilot and single-arm studies for other indications (eg, occipital neuralgia, phantom limb pain) report short-term pain reductions and technical feasibility but are limited by small sample sizes, lack of controls, and potential bias; further controlled trials are required.

Grigsby 2021, Prologo 2017 pilot studies summarized (chunks 236, 239).

inv-26: OCT middle ear imaging — evidence synthesis

Evidence summary regarding OCT for middle ear disorders and otoscopy:

Diagnostic performance: Small prospective and observational studies report that middle ear OCT can detect effusions and TM-adherent biofilms with high sensitivity/accuracy and may reduce antibiotic prescribing in early analyses; however evidence is limited by small sample sizes, manufacturer involvement, lack of independent large RCTs linking OCT use to improved patient outcomes, and technical acquisition failures in some patients.

Monroy 2018, Preciado 2020, Park 2018, interim RCT results indicate potential but insufficient evidence for routine coverage (chunks 246, 247, 249, 251–253).

inv-27: Summary criteria and limitations

Evidence-based coverage considerations (summary of reported study findings):

OCT detection of middle-ear biofilm validated: Intraoperative and in vivo handheld OCT identified TM‑adherent structures consistent with middle‑ear biofilm that were corroborated by confocal laser scanning microscopy and PCR in surgically sampled specimens in small studies, but clinical utility for routine diagnosis and management is unestablished.

Monroy et al. intraoperative sampling validated OCT findings in subsets (chunk 252).

OCT utility observations: Handheld OCT has been used to assess TM retraction, perforation margins, and postoperative healing and may differentiate effusion properties, but available studies are small and further validation is required.

Park 2018 and other small series report utility but limited evidence (chunks 252, 253, 255).

Technical limitations: OCT image acquisition can fail due to narrow/curved external auditory canal, profuse otorrhea, cholesteatoma material, cerumen, or poor cooperation, which may limit applicability in some patients.

Cho et al. documented acquisition failures (chunk 255).

Codes in this policy excerpt that are labeled “Unproven” do not have positive coverage criteria provided in the text and are treated as lacking sufficient evidence to support routine medical necessity. The Coverage Summary lists each code followed by a one-word conclusion (for example, 0061U — Unproven, 0075T/0076T — Unproven, 0163U — Unproven), and the policy rationale sections summarize the evidence limitations that underlie those conclusions.

The excerpt does not provide explicit positive coverage criteria or specific exclusions beyond indicating that certain codes and services are Unproven. Where a code is concluded to be Unproven, the document describes insufficient evidence of safety and/or efficacy rather than listing alternative allowed indications or conditional coverage rules.

The policy explicitly describes retinal prosthetic devices (e.g., Argus II system procedures) and blood‑based multi‑protein CRC biomarker panels (example: BeScreened™, code 0163U) as unproven and not medically necessary. The document states that retinal prostheses are unproven for inducing visual perception in retinitis pigmentosa and that the 3‑protein ELISA biomarker panel for colorectal cancer screening is unproven due to insufficient evidence.

The policy notes that algorithmic blood‑based biomarker panels (for example, BeScreened™/0163U) are unproven and not medically necessary for colorectal cancer or advanced adenoma screening. It also records that USPSTF screening recommendations do not include serum tests, urine tests, or capsule endoscopy for CRC screening, reflecting limited evidence for these approaches.

Automated or self‑administered speech and audiometry tests (including smartphone/tablet apps and automated audiometry CPT entries) are discussed as studied technologies but are characterized in this excerpt as unproven and not medically necessary when self‑administered or administered by non‑audiologists. The evidence summary indicates promising accuracy in some studies but insufficient validation to replace audiologist‑performed testing.

Transluminal peripheral atherectomy codes for renal/visceral/abdominal/brachiocephalic arteries (0234T–0237T) and the PreTRM multianalyte proteomic assay (reported via unlisted algorithmic code 81599) are specifically characterized as unproven and not medically necessary in the excerpt because of insufficient evidence of safety and/or efficacy.

Tear film imaging technologies (e.g., tear film imaging CPT entries) and myocardial sympathetic innervation imaging with 123I‑MIBG are described in the policy as unproven and not medically necessary for monitoring/assessing tear film disorders and as a prognostic marker in heart failure, respectively, citing insufficient evidence to support routine clinical use.

Automated visual evoked potentials (VEPs) for population screening are identified as unproven and not medically necessary for routine visual acuity screening. Sinus tarsi implants (subtalar arthroereisis) are also described as unproven and not medically necessary given low‑quality, heterogeneous evidence and concerns about complication and reoperation rates.

Specialty guidance and evidence assessments raise concerns about using subtalar arthroereisis as a solitary corrective procedure in certain adult acquired flatfoot deformities. The ACFAS statement and systematic reviews cited in the excerpt recommend caution and note that arthroereisis is evolving; NICE guidance recommends use only with special arrangements for governance, consent, and audit or research.

Radiostereometric analysis (RSA) techniques and whole‑body bioelectrical impedance analysis (BIA, CPT 0358T) are explicitly labeled in the document as unproven and not medically necessary for routine clinical use. The policy notes RSA is used in research (implant migration/fracture healing) but lacks evidence for routine patient management, and BIA accuracy is limited by hydration and standardization issues.

Professional society assessments summarized in the excerpt indicate that electronic brachytherapy is not supported as equivalent to standard surgical management for many skin cancers; societies recommend surgical management as the most effective treatment and suggest electronic brachytherapy only be considered in special circumstances or within prospective registries or trials.

Confocal laser endomicroscopy (CLE/pCLE) is described as an investigational adjunct: the policy states CLE is unproven and not medically necessary for routine replacement of histopathologic biopsy protocols. The evidence synthesis indicates CLE may be useful as an adjunct in expert centers (for biliary strictures or targeted biopsies) but is not sensitive or well‑validated enough to replace established biopsy protocols such as the Seattle protocol for Barrett’s esophagus.

For surveillance of Barrett’s esophagus, pooled evidence summarized in the excerpt indicates CLE is not sufficiently sensitive to replace the standard Seattle biopsy protocol; randomized data do not support routine substitution of CLE for systematic biopsies, so CLE should not be used as a standalone replacement for established histopathologic surveillance.

Codes and CPT/HCPCS Listings

Example listed codes and descriptionsCPT

0061U	Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis.
0075T	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel.
0076T	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure).
0163U	Oncology (colorectal) screening, biochemical enzyme-linked immunosorbent assay (ELISA) of 3 plasma or serum proteins (TDGF-1 [Cripto-1], CEA, ECM), with demographic data using a proprietary algorithm and reported as likelihood of CRC or advanced adenomas.

Additional omnibus codesCPT

0174T	Computer-aided detection (CAD) with further physician review for interpretation and report, chest radiograph(s), performed concurrent with primary interpretation.
0175T	Computer-aided detection (CAD) with further physician review for interpretation and report, chest radiograph(s), performed remote from primary interpretation.
0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral.
0212T	Comprehensive audiometry threshold evaluation and speech recognition (0209T, 0211T combined), automated.
0330T	Tear film imaging, unilateral or bilateral, with interpretation and report.
0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA).
0348T	Radiologic examination, radiostereometric analysis (RSA); spine.
0350T	Radiologic examination, radiostereometric analysis (RSA); lower extremity(ies).
0358T	Bioelectrical impedance analysis whole body composition assessment, with interpretation and report.

Omnibus/Listed CodesmixedNot Covered

0640T	Noncontact near-infrared spectroscopy, image acquisition, interpretation, and report; first anatomic site.
0647T	Insertion of gastrostomy tube, percutaneous, with magnetic gastropexy, under ultrasound guidance.
0651T	Magnetically controlled capsule endoscopy, esophagus through stomach, including intraprocedural positioning of capsule, with interpretation and report.
0658T	Electrical impedance spectroscopy of 1 or more skin lesions for automated melanoma risk score.
0659T	Transcatheter intracoronary infusion of supersaturated oxygen in conjunction with PCI during AMI.
0664T	Donor hysterectomy, open, from cadaver donor.
0665T	Donor hysterectomy, open, from living donor.
0666T	Donor hysterectomy, laparoscopic or robotic, from living donor.
0667T	Recipient uterus allograft transplantation from cadaver or living donor.
0668T	Backbench standard preparation of uterine allograft.

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Procedure and Proprietary Test Codesmixed

0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy.
0472T	Device evaluation, interrogation, and initial programming of intraocular retinal electrode array (e.g., retinal prosthesis), in person, with iterative adjustment of the implantable device.
0473T	Device evaluation and interrogation of intraocular retinal electrode array, in person, including reprogramming and visual training.
L8608	Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System.
0163U	Oncology (colorectal) screening, biochemical ELISA of 3 plasma or serum proteins with demographic data using proprietary algorithm reported as likelihood of CRC or advanced adenomas.

Not covered / unproven molecular diagnostic codeHCPCSNot Covered

0163U

Oncology (colorectal) screening, biochemical enzyme-linked immunosorbent assay (ELISA) of 3 plasma or serum proteins with demographic data using a proprietary algorithm reported as likelihood of CRC or advanced adenomas.

Not covered / CAD chest radiograph codesHCPCSNot Covered

0174T	Computer-aided detection (CAD) with physician review, chest radiograph(s), performed concurrent with primary interpretation.
0175T	Computer-aided detection (CAD) with physician review, chest radiograph(s), performed remote from primary interpretation.

Not covered / meibomian gland evacuation codesHCPCSNot Covered

0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral.
0563T	Evacuation of meibomian glands, using heat delivered through wearable, open-eye eyelid treatment devices and manual gland expression, bilateral.

Automated audiometry CPT codes mentionedCPT

0208T	Pure tone audiometry (threshold), automated; air only.
0209T	Pure tone audiometry (threshold), automated; air and bone.
0210T	Speech audiometry threshold, automated.
0211T	Speech audiometry threshold, automated; with speech recognition.
0212T	Comprehensive audiometry threshold evaluation and speech recognition (0209T, 0211T combined), automated.

Atherectomy (listed codes)CPTNot Covered

0234T	Transluminal peripheral atherectomy; renal artery.
0235T	Transluminal peripheral atherectomy; visceral artery (except renal), each vessel.
0236T	Transluminal peripheral atherectomy; abdominal aorta.
0237T	Transluminal peripheral atherectomy; brachiocephalic trunk and branches, each vessel.

PreTRM / proteomic assayCPTNot Covered

81599

Unlisted multianalyte assay with algorithmic analysis (when used to report PreTRM).

Other listed HCPCS/CPT-III/Category III codes mentionedmixed

0247U	Obstetrics (preterm birth), insulin-like growth factor-binding protein 4 (IBP4), sex hormone-binding globulin (SHBG), quantitative measurement by LC-MS/MS.
0330T	Tear film imaging, unilateral or bilateral, with interpretation and report.

Tear film imaging CPT (listed)CPT

0330T

Tear film imaging, unilateral or bilateral, with interpretation and report.

123I-MIBG imaging CPT (listed)CPT

0331T	Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment.
0332T	Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment; with tomographic SPECT.

VEP Related CPT/Category IIICPT

0333T

Visual evoked potential, screening of visual acuity, automated, with report.

Sinus tarsi implant / subtalar arthroereisisCPT | HCPCS

0335T	Insertion of sinus tarsi implant.
0510T	Removal of sinus tarsi implant.
0511T	Removal and reinsertion of sinus tarsi implant.
S2117	Arthroereisis, subtalar.

Covered CPT Codes (listed in document)CPT

0338T	Transcatheter renal sympathetic denervation, percutaneous approach; unilateral.
0339T	Transcatheter renal sympathetic denervation, percutaneous approach; bilateral.

Radiostereometric analysis (RSA) CPT Category III codesCPTNot Covered

0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA).
0348T	Radiologic examination, radiostereometric analysis (RSA); spine.
0349T	Radiologic examination, radiostereometric analysis (RSA); upper extremity(ies).
0350T	Radiologic examination, radiostereometric analysis (RSA); lower extremity(ies).

Bioelectrical impedance analysis (BIA)CPTNot Covered

0358T

Bioelectrical impedance analysis whole body composition assessment, with interpretation and report.

Not medically necessary / Unproven CPT CodesCPTNot Covered

0358T

Bioelectrical impedance analysis whole body composition assessment, with interpretation and report.

Not medically necessary / Unproven CPT CodesCPTNot Covered

0395T

High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed.

Optical endomicroscopy / CLE related codesCPT

0397T	ERCP with optical endomicroscopy (list separately in addition to code for primary procedure).
43206	Esophagoscopy, flexible, transoral; with optical endomicroscopy.
43252	Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy.
88375	Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session.

CCM device/procedure codesCPT/HCPCS

0408T	Insertion or replacement of permanent cardiac contractility modulation system; pulse generator with transvenous electrodes.
0409T	Insertion or replacement of permanent cardiac contractility modulation system; pulse generator only.
0410T	Insertion or replacement of permanent cardiac contractility modulation system; atrial electrode only.
0411T	Insertion or replacement of permanent cardiac contractility modulation system; ventricular electrode only.
0412T	Removal of permanent cardiac contractility modulation system; pulse generator only.
0413T	Removal of permanent cardiac contractility modulation system; transvenous electrode (atrial or ventricular).
0414T	Removal and replacement of permanent cardiac contractility modulation system pulse generator only.
0415T	Repositioning of previously implanted cardiac contractility modulation transvenous electrode (atrial or ventricular lead).
0416T	Relocation of skin pocket for implanted cardiac contractility modulation pulse generator.
0417T	Programming device evaluation (in person) with iterative adjustment of the implantable device; implantable CCM system.

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Percutaneous cryoablation codesCPT

0440T	Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve.
0441T	Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve.
0442T	Ablation, percutaneous, cryoablation, includes imaging guidance; nerve plexus or other truncal nerve.

Drug-eluting ocular insert CPT II/T codesCPTNot Covered

0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids, including fitting, training, and insertion, unilateral or bilateral.
0445T	Subsequent placement of a drug-eluting ocular insert under one or more eyelids, including re-training, and removal of existing insert, unilateral or bilateral.

Middle ear OCT codesCPTNot Covered

0485T	Optical coherence tomography (OCT) of middle ear, with interpretation and report; unilateral.
0486T	Optical coherence tomography (OCT) of middle ear, with interpretation and report; bilateral.

Wireless LV pacing CPTs (cardiac)CPT

0515T	Insertion of wireless cardiac stimulator for left ventricular pacing, complete system.
0516T	Insertion of wireless cardiac stimulator for left ventricular pacing, electrode only.
0517T	Insertion of wireless cardiac stimulator for left ventricular pacing, pulse generator components only.
0518T	Removal of pulse generator for wireless cardiac stimulator; battery component only.
0519T	Removal and replacement of pulse generator for wireless cardiac stimulator; both components.
0520T	Removal and replacement of pulse generator; battery component only.
0521T	Interrogation device evaluation (in person) for wireless cardiac stimulator.
0522T	Programming device evaluation (in person) for wireless cardiac stimulator.
0861T	Removal of pulse generator for wireless cardiac stimulator; both components.
0862T	Relocation of pulse generator; battery component only.

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Study sample sizes referenced

Jett et al.299 limbs from 154 patients (observational SFDI study).

Weinkauf47 patients (94 limbs).

ContextSample sizes reflect small-to-moderate observational cohorts cited to support early SFDI feasibility and diagnostic comparisons rather than definitive outcomes evidence.

Resistant hypertension definition

Definition (clinical threshold)Resistant hypertension: blood pressure > 130/80 mm Hg despite treatment with three medications at maximally tolerated doses.

Medication contextMedications should be from classes with outcomes data (ACEi/ARB, calcium channel blocker, thiazide diuretic, or beta blocker).

Selection implicationRDN is considered only after lifestyle modification and medication optimization have failed to control BP.

Situations Considered (Investigation vs Coverage)

inv-194: Procedure-specific descriptions only; no approved indications in this excerpt

Procedure-specific descriptions only; no approved indications in this excerpt

Procedure-specific descriptions: The omnibus procedure listings provide descriptive ICD/CPT language and intended anatomic/technical context but, within this excerpt, do not establish positive coverage criteria; most are designated 'Unproven'.

See omnibus code listings (chunk 8 and surrounding chunks).

inv-195: Assessment of tissue oxygenation and microvascular disease in the foot

Assessment of tissue oxygenation and microvascular disease in the foot

SFDI assessment context: SFDI is described as an optical method to map superficial tissue oxygenation and hemoglobin content and has been studied to stratify microvascular disease severity in the foot, but clinical utility for improving wound or limb outcomes is unproven; prospective outcome studies are needed.

Jett and Weinkauf observational studies and ECRI assessment summarized (chunks 32–34).

inv-196: Extracranial vertebral artery stenting during EVT for posterior circulation tandem lesion stroke

Extracranial vertebral artery stenting during EVT for posterior circulation tandem lesion stroke

PCTL EVT with VA stenting consideration: In acute posterior circulation tandem lesion stroke treated with EVT within 24 hours, observational registry data suggest extracranial vertebral artery stenting during mechanical thrombectomy may improve functional outcomes and reduce mortality, but evidence is nonrandomized and insufficient to support routine coverage; randomized trials are needed.24 hours

Li et al. pooled BASILAR+PERSIST registry data report adjusted favorable outcomes but limitations include selection bias (chunks 36–37).

inv-197: Acute posterior circulation tandem lesion (PCTL) stroke — consideration of extracranial vertebral artery stenting during EVT

Acute posterior circulation tandem lesion (PCTL) stroke — consideration of extracranial vertebral artery stenting during EVT

PCTL EVT with consideration of extracranial VA stenting: For acute PCTL causing AIS treated with mechanical thrombectomy within approximately 24 hours of estimated occlusion time, clinicians may consider extracranial vertebral artery stenting during EVT on a case-by-case basis given registry signals of benefit, but lack of randomized evidence and guideline caution mean routine coverage is not supported.24 hours

Observational data suggest benefit but are nonrandomized; ESVS guidance cautions routine stenting (chunks 36–38).

inv-198: Use of CAD or AI-assisted interpretation for chest radiographs is not supported as standard of care

Use of CAD or AI-assisted interpretation for chest radiographs is not supported as standard of care for improving diagnostic sensitivity or outcomes based on current evidence.

CAD/AI chest radiograph stance: Current evidence does not support routine use of CAD or AI-assisted interpretation for chest radiographs to improve diagnostic sensitivity or outcomes; randomized and systematic review data are inconclusive and at least one RCT showed no improvement in sensitivity or false-positive rates.

Hwang et al. RCT and systematic reviews summarized (chunks 64–65).

inv-199: Mobile/automated audiometry applications and devices

Mobile/automated audiometry applications and devices

Mobile audiometry evidence: Mobile and automated audiometry demonstrate promising accuracy and high pooled sensitivity/specificity in meta-analyses and may be useful where conventional audiometry is unavailable, but heterogeneity, age-related accuracy differences (children/elderly), and study quality limitations mean they are investigational as replacements for standard pure-tone audiometry.

Systematic reviews and meta-analyses summarized in chunks 90–96.

inv-200: Dry eye disease / tear film assessment (investigational)

Dry eye disease / tear film assessment (investigational)

Tear film imaging investigational: Tear film imaging techniques (interferometry, meniscometry, high-speed video topography, OCT) are under investigation for evaluation and monitoring of dry eye disease and meibomian gland dysfunction; studies show variable repeatability and device disagreement and do not establish clear diagnostic performance or outcome benefit, therefore tear film imaging is investigational.

AAO guidelines do not endorse routine use; small comparative studies report correlations but not definitive clinical utility (chunks 111, 113, 117).

inv-201: Prognostic assessment in heart failure (investigational)

Prognostic assessment in heart failure (investigational)

123I‑MIBG prognostic context: 123I‑MIBG planar/SPECT imaging has been associated with prognostic stratification in heart failure cohorts using H/M ratio and SPECT total defect scores, but evidence is observational and insufficient to support routine prognostic-guided management decisions; further multicenter outcome studies are needed.H/M <1.60 indicates higher risk in ADMIRE-HF follow-up

OPAR and ADMIRE-HF follow-up studies report associations but not demonstrated management benefit (chunks 120, 123, 126–127).

inv-202: 123I‑MIBG planar/SPECT for prognostic assessment in heart failure

123I‑MIBG planar/SPECT for prognostic assessment in heart failure

Prognostic imaging note: Use of 123I‑MIBG planar/SPECT to measure heart‑to‑mediastinum (H/M) ratio and SPECT total defect score can stratify mortality and arrhythmic risk in HF cohorts (eg, ADMIRE‑HF H/M <1.60 associated with higher mortality), but routine clinical use to guide therapy is unproven.H/M <1.60

Observational follow-up analyses summarized (chunks 126–127).

inv-203: VEPs for objective acuity estimation in selected patients

VEPs for objective acuity estimation in selected patients

VEP diagnostic use: Pattern and transient VEPs can estimate visual acuity objectively and may be useful diagnostically or prognostically in preverbal children or individuals with motor/learning impairments when interpreted using age‑stratified reference data; they are not supported for routine population screening.

Systematic review and clinical guidance summarized (chunks 130–132).

inv-204: Subtalar arthroereisis considered only after conservative therapy; not supported as routine definitive treatment

Subtalar arthroereisis considered only after conservative therapy; not supported as routine definitive treatment

Arthroereisis caution: Subtalar arthroereisis (sinus tarsi implant) has been used for symptomatic flexible pes planus after failure of conservative care, but evidence quality is low, complication and implant removal rates are substantial in some reports, and professional guidance recommends against its use as a sole corrective procedure for certain adult AAFD stages; thus it is not supported as routine definitive treatment.

Systematic reviews and consensus statements summarized (chunks 138–145).

inv-205: Implant migration monitoring and fracture healing assessment (research/registry contexts)

Implant migration monitoring and fracture healing assessment (research/registry contexts)

RSA research use: Radiostereometric analysis (RSA) is routinely used in clinical research and phased implant introduction to monitor early implant migration and fracture healing with high precision, but routine clinical utility and evidence that RSA-based decisions improve outcomes are not established.

RSA technical requirements and research utility described (chunks 175, 177–179).

inv-206: Breast cancer (APBI) — not recommended outside trials

Breast cancer (APBI) — not recommended outside trials

APBI electronic brachytherapy stance: Electronic brachytherapy for accelerated partial breast irradiation (APBI) is not recommended for routine use outside prospective clinical trials or registries due to randomized data showing higher recurrence and insufficient long‑term follow up.

ABS, ECRI and randomized trial evidence cited (chunks 191–195).

inv-207: Nonmelanoma skin cancer — limited/experimental

Nonmelanoma skin cancer — limited/experimental

NMSC electronic brachytherapy stance: Electronic surface brachytherapy for nonmelanoma skin cancer has insufficient long‑term comparative evidence and is considered limited/experimental; use is recommended only in clinical trials or registries.

ECRI and professional society statements summarized (chunks 193–195).

inv-208: Gynecologic cancers — investigational

Gynecologic cancers — investigational

Gynecologic EBT stance: Evidence for electronic brachytherapy in gynecologic cancers is limited to small case series at high risk of bias and does not demonstrate superiority to conventional brachytherapy; use remains investigational.

ECRI assessment noted inconclusive data (chunk 197).

inv-209: Situations where CLE/pCLE has been studied

Situations where CLE/pCLE has been studied

pCLE study contexts: CLE/pCLE has been studied for biliary strictures, Barrett's esophagus surveillance, gastric and colorectal lesion characterization, and other GI mucosal/neoplastic disease; pooled analyses show high sensitivity for some indications but evidence is heterogeneous and primarily from specialized centers.

Meta-analyses and systematic reviews summarized (chunks 208, 209, 216).

inv-210: Use of CLE for diagnostic evaluation of GI mucosal/neoplastic disease

Use of CLE for diagnostic evaluation of GI mucosal/neoplastic disease

CLE diagnostic contexts: CLE may improve per‑lesion detection of neoplasia in select settings and shows high pooled sensitivity for biliary strictures when combined with ERCP, but trials do not support routine replacement of standard biopsy protocols (eg, Seattle protocol) and benefit is greatest in expert centers.

Systematic reviews and RCT data summarized (chunks 216–218).

inv-211: OCT for evaluation of suspected middle ear effusion/biofilm and structural assessment of the tympanic membrane

OCT for evaluation of suspected middle ear effusion/biofilm and structural assessment of the tympanic membrane

OCT middle ear study indications: Studies have evaluated OCT for detection/characterization of middle ear effusion, identification of TM‑adherent biofilms, assessment of TM perforation/retraction margins, and postoperative healing; preliminary data show promising diagnostic accuracy but are limited in size and do not yet establish clinical outcome benefit.

Preciado, Monroy, Park studies summarized (chunks 251–253).

inv-212: OCT of the tympanic membrane/middle ear — investigational

OCT of the tympanic membrane/middle ear — investigational

OCT investigational stance: Handheld and intraoperative OCT imaging of the tympanic membrane/middle ear remain investigational; while imaging correlates with surgical/pathologic findings in small series, larger prospective trials demonstrating impact on management and outcomes are needed.

Monroy and Park studies and AAO‑HNS guideline absence noted (chunks 252, 254, 255).

inv-213: MPOD measurement by HFP — unproven/not medically necessary

MPOD measurement by HFP — unproven/not medically necessary

Primary stance: Heterochromatic flicker photometry measurement of macular pigment optical density (MPOD; CPT 0506T) is unproven and not medically necessary due to methodological concerns and limited evidence of clinical utility.

Studies highlight measurement assumptions and potential biases (chunks 258, 260).

inv-214: Near-infrared dual imaging of meibomian glands — unproven/not medically necessary

Near-infrared dual imaging of meibomian glands — unproven/not medically necessary

Primary stance: Near‑infrared dual imaging of meibomian glands (CPT 0507T) is unproven and not medically necessary due to insufficient evidence that imaging improves diagnostic decision‑making or patient outcomes; professional guidance is lacking.

Manufacturer descriptions exist but clinical effectiveness is not established (chunks 263–264).

Prior Authorization, Documentation, and Billing Implications

Prior Authorization

Prior Authorization for Listed Codes

Prior authorization expectations and billing/denial implications for the services and codes addressed in this policy: claims for codes designated "Unproven" or "Not medically necessary" may require prior authorization or will be subject to medical necessity review and potential denial. Providers should document indication-specific clinical information, device regulatory status, prior conservative therapy, and trial/registry participation where noted to support medical necessity reviews.

Document code-specific conclusions from the Coverage Summary when submitting claims.
Expect prior authorization or pre-service review for investigational device implants or device-based procedures (for example, retinal prosthesis implantation, CCM systems, RDN devices) as appropriate to the payer.
Governance/audit processes may require prior authorization records, registries, or trial identifiers when coverage is contingent on study or registry participation.

Prior Authorization

Prior Authorization — Noted Codes

Certain codes and procedures listed in the policy are explicitly noted as "Unproven" or "Not medically necessary." When these services are proposed, prior authorization may be required but is unlikely to be approved unless robust supportive evidence and documentation are provided. Providers should anticipate preauthorization requests and possible denial if documentation is insufficient.

Examples of noted codes: 0061U, 0075T–0076T, 0100T, 0163U, 0234T–0237T, 0347T–0350T, 0358T, 0395T, 0444T–0445T, 0485T–0486T, 0640T, 0647T, 0651T, 0658T, 0659T, 0664T–0668T, 77424, 0174T–0175T, 0207T, 0563T, 0234T–0237T, 81599 (PreTRM).
Prior authorization should reference the specific code conclusion from the policy (e.g., "Unproven").

Prior Authorization

Argus II — Prior Authorization / Approval Considerations

Argus II (retinal prosthesis) implantation is associated with Humanitarian Device Exemption (HDE) criteria and postapproval study obligations; prior authorization or case review should verify that FDA HDE indications and required documentation are met before approval.

Required documentation to support authorization: patient age (≥25 years), evidence of severe-to-profound retinitis pigmentosa with bare light or no light perception in both eyes (or documented intact inner retinal function if no light perception), prior history of useful form vision, lens status (aphakic/pseudophakic or plan for lens removal if phakic), and willingness/ability to attend postimplant follow-up, device fitting, and visual rehabilitation.
Document device regulatory status (HDE) and participation in any required post‑approval studies or registry; note that manufacturing of Argus II has ceased and device availability/market status should be confirmed.
Include outcome measures and testing results used in trials (e.g., square localization, direction of motion, grating visual acuity) when available.

Prior Authorization

Prior Authorization Implication

When policy conclusions label technologies as unproven or not medically necessary, prior authorization implications typically include pre-service denial or requirement for extensive supporting documentation. Providers should expect insurers to require evidence that a service meets medical necessity criteria or falls within an FDA-approved indication before authorizing services.

Document any attempts at conservative management and rationale for proceeding to the proposed procedure.
If the procedure/device has an FDA approval or HDE with specific indications (e.g., RDN systems, CCM), include device PMA/HDE identifiers and confirm the indication matches patient presentation.
For services considered appropriate only in the context of clinical trials or registries (e.g., electronic brachytherapy, certain novel imaging), include trial/registry identifiers and consent documentation when available.

Denial Risk

Prior Authorization Expectation for Unproven Services

For services described as unproven or not medically necessary (e.g., biomarker panels, automated VEPs, PreTRM, CAD of chest radiographs, eyelid thermal pulsation/wearable devices, BIA, electronic brachytherapy, percutaneous cryoablation of peripheral lesions where noted), prior authorization is likely to be denied absent strong peer-reviewed evidence or inclusion in a recognized prospective registry or clinical trial.

BeScreened™-type biomarker CRC panels (0163U) — anticipated denial unless evidence beyond proprietary algorithm demonstrates clinical utility for screening.
PreTRM (81599 used to report) — considered unproven for predicting preterm labor; expect denial without convincing prospective validation.
Automated VEPs for acuity screening — unproven; anticipate denial for screening indications.
Thermal pulsation (0207T/0563T) and wearable eyelid heat devices — unproven; prior authorization unlikely to be approved.
Computer-aided detection (0174T/0175T) for chest radiographs — unproven; expect denial for routine use.

Prior Authorization

Prior Authorization Likely for Unproven Indications

Some unproven indications (e.g., sinus tarsi implants, radiostereometric analysis, whole-body BIA) are likely to trigger preauthorization requirements for implants or procedures that involve devices or durable equipment; documentation of conservative therapy and indication-specific evaluation is expected.

Sinus tarsi implant procedures (0335T, 0510T, 0511T, S2117) — unproven; prior authorization expected for implant placement and likely denial unless compelling evidence and failure of conservative management are documented.
Radiostereometric analysis codes (0347T–0350T) and whole-body BIA (0358T) — unproven; expect pre-service review and likely denial for routine clinical use.

Prior Authorization

Prior Authorization Likely for Renal Denervation

Renal denervation (RDN) systems have evolving FDA regulatory statuses; when proposed as treatment for hypertension, prior authorization should verify that patient selection aligns with device-specific approvals and that medical therapy optimization has been attempted.

Document device regulatory status and PMA number when applicable (e.g., Paradise™ Ultrasound system, Symplicity Spyral™).
Optimize medications before RDN: document trials of lifestyle modification and multidrug antihypertensive regimens with maximally tolerated doses (per SCAI/NKF and trial protocols).
RDN documentation expectations: baseline ambulatory and office BP values, medication list and adherence, contraindications, anatomical suitability, shared decision-making notes, and consideration of registry/trial enrollment when available.

Documentation Required

Coding and Coverage Stance

Coding and coverage stance: the policy designates many listed CPT/HCPCS codes as Unproven or Not Medically Necessary; providers must reference these code-specific conclusions when requesting authorization or appealing denials.

Document the exact code(s) and corresponding policy conclusion on all authorization requests and claims submissions.
When a code is marked unproven, expect denial risk and include all supporting clinical evidence and rationale if requesting exception or coverage.

Prior Authorization

Prior Authorization May Be Required

Authorization may be required for device implants, high-cost therapeutic procedures, or tests intended for clinical decision-making; when a policy notes registry/trial-preferred use (e.g., electronic brachytherapy, novel implants), prior authorization should include trial or registry participation details.

For therapies recommended only in registries/clinical trials, include the registry name/ID and documentation of informed consent and enrollment.
For cardiac contractility modulation (CCM) or other implantable device procedures, include FDA approval/PMA details and device recall status if applicable (e.g., Optimizer recall notification).

Denial Risk

Ocular Insert Codes and Middle-Ear OCT — Not Medically Necessary

Certain ocular insert and middle-ear OCT codes are explicitly considered not medically necessary; expect denial and/or preauthorization requirements for placement or imaging devices absent strong evidence or specific indications.

Drug-eluting ocular inserts (0444T, 0445T) — placement considered unproven and not medically necessary; prior authorization requests will likely be denied without robust RCT evidence.
Middle ear OCT (0485T, 0486T) — unproven for diagnosing/managing middle ear disorders; prior authorization and denial risk for routine use.
Include documentation of standard diagnostic steps (e.g., tympanometry, pneumatic otoscopy per AAO‑HNS) before considering OCT.

Denial Risk

Denial Risk for Unproven Codes and Services

Denial risk for services labeled Unproven: claims submitted for listed CPT/HCPCS codes may be denied or considered not covered when codes are designated as Unproven or Not Medically Necessary; providers should supply clear, code-specific clinical rationale and supporting literature if appealing.

Policy examples with high denial risk: 0163U (BeScreened-type biomarker panel), 81599 (PreTRM), 0174T/0175T (CAD chest radiograph), 0207T/0563T (thermal pulsation/wearable eyelid devices), 0347T–0350T (RSA), 0395T (electronic brachytherapy).
Denial risk also applies to unlisted or omnibus codes used to report investigational procedures (e.g., 64999, 81599).

Denial Risk

Examples of Denial Triggers for Unproven Services

Specific denial triggers called out in the policy include biomarker panels for colorectal cancer screening, eyelid thermal pulsation/wearable devices, PreTRM proteomic test, CAD for chest radiographs, and various imaging-based diagnostics; submitters should expect claim denial absent validated clinical utility evidence.

BeScreened™-type biomarker panels (0163U) — denial trigger for CRC screening use.
Thermal pulsation/wearable eyelid heat devices (0207T, 0563T) — denial trigger for MGD/DED treatment claims.
PreTRM (81599) — denial trigger for preterm labor risk screening.
CAD for chest radiographs (0174T/0175T) — denial trigger for routine radiograph interpretation.

Documentation Required

Documentation to Support Medical Necessity Reviews

Documentation expectations and clinical support to reduce denial risk: provide indication documentation, prior conservative therapy, imaging metrics and confirmatory correlation, device regulatory status, and supportive clinical evidence including outcome measures reported in studies.

Indication documentation: presenting symptoms, diagnostic test results, and prior treatments attempted (conservative treatment before surgery where applicable).
Imaging and confirmatory correlation: include relevant imaging reports, test metrics (e.g., ambulatory BP readings for RDN), and any confirmatory pathology or functional testing.
Device regulatory status: include FDA PMA/HDE numbers, recall notices, and device availability.
Studies report outcome measures such as: functional scores (e.g., mRS for stroke, 6-minute walk for CCM), blood pressure reductions (office and ambulatory systolic/diastolic for RDN), visual function tests (square localization, grating visual acuity for Argus II), and safety/adverse event rates; include these when relevant to support medical necessity.
Supporting references: cite key trials, systematic reviews, PMA/HDE documentation, and guideline statements referenced in the policy when submitting prior authorization requests or appeals.

Documentation Required

Imaging and Test-Specific Documentation Requirements

Testing-specific documentation expectations: certain imaging and diagnostic tests require particular pretest and posttest documentation to support clinical utility (e.g., 123I‑MIBG imaging, myocardial sympathetic innervation imaging; pCLE results; automated VEPs). Include test descriptions, intended clinical question, and how results will change management.

Test description: describe the test modality, purpose, and how results will be used to guide care.
123I‑MIBG imaging: document indication (prognostic evaluation in heart failure) and correlation with other clinical and imaging data; note that policy considers it unproven as a prognostic marker.
pCLE/CLE: when used as adjunct diagnostic testing (e.g., indeterminate biliary strictures), include comparison to ERCP tissue sampling and explain how pCLE findings will impact management; expect preauthorization for experimental use.
Automated VEPs: include age-appropriate screening rationale, expected impact on management, and supporting literature; policy deems automated VEPs unproven for visual acuity screening.

Step Therapy

Conservative Treatment and Therapy Sequencing Expectations

Procedure sequencing and conservative care expectations: many device- or procedure-based interventions require documentation of conservative therapy prior to approval; follow guideline-recommended steps and document attempts at optimal medical therapy where specified.

Medical therapy before revascularization and therapy sequencing with optimal medical therapy (OMT) should be documented for vascular interventions (e.g., vertebral artery stenting).
Conservative treatment before surgery: document nonoperative management attempts where applicable (e.g., sinus tarsi implant considered only after failed conservative care).
Eyelid thermal pulsation — step therapy note: document prior conventional treatments (warm compresses, lid hygiene, manual expression) before considering automated thermal/evacuation devices; policy stance remains unproven.
Optimize medications before RDN: provide medication lists, dosages, adherence evidence, and attempts at lifestyle modification as per SCAI guidance.

Note

Technical Acquisition Limitations and Operational Notes

Operational and technical limitations that affect authorization and billing: some diagnostics (e.g., middle-ear OCT) may fail to acquire usable images in specific anatomic or clinical situations; record technical acquisition limitations in the chart to explain incomplete studies.

Technical acquisition limitations for middle-ear OCT: narrow/curved external auditory canal, profuse otorrhea, cholesteatoma material, cerumen, and poor patient compliance can prevent image acquisition — document these when OCT images are unavailable.
No explicit prior authorization or billing steps are specified for certain services in the policy; however, absence of explicit preauthorization requirements does not preclude medical necessity review or retrospective denial.

Policy Scope and Rationale

This policy provides concise coverage conclusions for many recently introduced Category III, T, and U CPT/HCPCS codes. For each listed code the excerpt reports a one‑word coverage conclusion (often “Unproven”) and gives a brief clinical description and rationale where available; the intent is to document UnitedHealthcare’s assessment of evidence for routine coverage of these newer/omnibus codes.

0061U — SFDI description (definition)

Code descriptor0061U: Transcutaneous measurement of five biomarkers (StO2, ctHbO2, ctHbR, ctHb1, ctHb2) using spatial frequency domain imaging (SFDI) and multi-spectral analysis.

ModalitySpatial Frequency Domain Imaging (SFDI): non-contact optical technique producing 2D/3D maps of tissue oxygenation and hemoglobin metrics.

Intended use noteReported to assess superficial tissue oxygenation in patients with potential circulatory compromise; intended as part of a larger assessment battery, not a standalone diagnostic.

0174T / 0175T — CAD for chest radiographs (definition)

Code descriptors0174T/0175T: Computer-aided detection (CAD) for chest radiographs — algorithmic analysis with subsequent physician review; concurrent (0174T) or remote (0175T) implementation.

ProcessAlgorithm identifies candidate lesions on digital chest radiograph images; physician performs further review and issues interpretation/report.

Coverage stanceDeclared Unproven and not medically necessary due to insufficient evidence that CAD improves diagnostic outcomes.

SFDI definition — Spatial Frequency Domain Imaging

TechniqueSpatial Frequency Domain Imaging (SFDI): an optical method that quantitatively characterizes turbid (multiple-scattering) tissues and maps tissue oxygenation and hemoglobin content.

OutputsGenerates approximate values of oxygen saturation, oxyhemoglobin, and deoxyhemoglobin presented in 2D/3D visual maps.

Device exampleClarifi® Imaging System uses SFDI and multispectral analysis for non-contact tissue oxygenation measurement.

Clarifi Imaging System — definition/clearance note

DeviceClarifi® Imaging System: a non-contact, noninvasive tissue oxygenation measurement system using SFDI and multispectral analysis.

Regulatory statusManufacturer describes it as providing approximate oxygenation and hemoglobin metrics; intended as part of a larger clinical assessment and not for standalone diagnosis.

Clinical noteFDA 510(k) clearance noted for related systems but clearance does not establish clinical utility per policy evidence synthesis.

PCTL — definition for posterior circulation tandem lesion

DefinitionPCTL (posterior circulation tandem lesion): concurrent extracranial vertebral artery lesion and intracranial posterior circulation occlusion treated during endovascular therapy (EVT).

Clinical contextConsideration arises when performing mechanical thrombectomy for acute posterior circulation ischemic stroke within ~24 hours of occlusion onset.

ImplicationRegistry data suggest potential benefit of extracranial VA stenting during EVT in PCTL but randomized trials are lacking.

HDE — Humanitarian Device Exemption definition and relation to Argus II

DefinitionHumanitarian Device Exemption (HDE): an FDA regulatory pathway permitting limited device approval for rare conditions, with required post-approval studies noted for Argus II.

Argus II contextArgus II received HDE approval for severe-to-profound retinitis pigmentosa with specified criteria (age ≥25, bare/no light perception, prior useful vision, willingness for follow-up); manufacturing has ceased.

ImplicationHDE approval does not imply broad clinical effectiveness; post-approval study requirements apply.

BeScreened™-CRC / 0163U — brief test description

TestBeScreened™-CRC (0163U): ELISA-based multiplexed plasma/serum three-protein panel (TDGF-1/Cripto-1, CEA, ECM) combined with demographic data and a proprietary algorithm to report likelihood of colorectal cancer or advanced adenomas.

Intended useReported as a screening likelihood score for CRC/advanced adenomas rather than definitive diagnosis.

Coverage stanceConsidered unproven and not medically necessary for CRC screening due to insufficient evidence.

CAD for chest radiographs — algorithm with physician review

Algorithm + physician reviewCAD for chest radiographs performs automated lesion detection followed by physician review of algorithm-identified findings prior to final interpretation.

Implementation modesCan be performed concurrently with primary interpretation (0174T) or remotely (0175T).

Evidence notePolicy concludes CAD for chest radiographs is unproven and not medically necessary based on insufficient evidence of improved diagnostic outcomes.

Evacuation of meibomian glands — codes 0563T / 0207T definition

Codes0563T / 0207T: Evacuation of meibomian glands using heat-delivery devices (wearable open-eye or automated thermal pulsation).

Procedure descriptionAutomated thermal pulsation applies localized heat and intermittent pressure; wearable devices apply blink-assisted localized heat typically followed by manual expression.

Policy stanceThese procedures are considered unproven and not medically necessary for evaluation or evacuation of meibomian glands.

VTPT / LipiFlow — definition

VTPT / LipiFlowVectored thermal pulsation treatment (VTPT, LipiFlow): a single-session device-delivered thermal pulsation intended to relieve meibomian gland obstruction and improve tear film metrics.

Typical effect durationSome studies report sustained improvement in signs/symptoms up to 12 months after a single treatment; evidence limited by small trials and risk of bias.

Evidence limitationsMany trials are small, manufacturer-funded, and lack long-term, independently replicated outcomes.

TearCare / earCare — wearable open-eye eyelid thermal system definition

TearCare / earCareWearable open-eye eyelid thermal systems (e.g., TearCare, earCare) deliver targeted heat to the tarsal plates/meibomian glands with blink-assisted application, often followed by manual gland expression.

Device comparisonsRandomized trials compare TearCare to LipiFlow or other controls with mixed results; evidence gaps and potential manufacturer bias exist.

Policy conclusionThese wearable devices are considered unproven and not medically necessary for evaluation or evacuation of meibomian glands.

Atherectomy — definition reference

DefinitionAtherectomy: endovascular removal of atheromatous plaque by cutting, drilling, shaving, pulverizing, lasing, or sanding to improve vessel lumen and compliance.

Device typesIncludes directional, rotational, orbital, intravascular lithotripsy, excimer laser, and chronic total occlusion recanalization systems.

Evidence noteFor visceral/renal/abdominal/brachiocephalic arteries, published evidence is limited to case reports; effectiveness and safety versus standard treatments not established.

PreTRM (IBP4/SHBG) — definition

PreTRM (IBP4/SHBG)Serum-based proteomic biomarker test measuring IBP4 and SHBG to predict risk of spontaneous preterm birth; reported via multianalyte algorithm (PreTRM).

Intended useProposed for screening asymptomatic pregnant individuals to stratify preterm birth risk for potential targeted interventions.

Policy stanceConsidered unproven and not medically necessary due to insufficient evidence for screening utility and clinical benefit.

Tear film imaging techniques definition

DefinitionTear film imaging: collection and processing of reflected light or images (interferometry, meniscometry, high-speed video topography, OCT) to evaluate ocular surface and tear film dynamics.

PurposeInvestigational tools to characterize tear film and meibomian gland function for dry eye disease assessment and monitoring.

Evidence limitationsGuidelines (AAO) do not currently endorse routine use; studies show variability, poor device agreement, and small sample sizes.

123I-MIBG H/M ratio and TDS metric definitions

H/M ratio and TDS123I‑MIBG metrics: heart-to-mediastinum (H/M) ratio on planar imaging and total defect score (TDS) on SPECT — used as prognostic imaging markers of myocardial sympathetic innervation.

Clinical meaningLower late H/M ratios are associated with higher all-cause and cardiac mortality in observational cohorts (e.g., ADMIRE-HF stratification at H/M <1.60).

LimitationPrognostic associations do not establish that imaging-guided management improves outcomes; methods require standardization.

heart/mediastinum (H/M) ratio definition

H/M ratioHeart/mediastinum (H/M) ratio: planar imaging metric of cardiac 123I‑MIBG uptake comparing heart counts to mediastinal background; lower values indicate poorer sympathetic innervation.

Prognostic thresholdADMIRE-HF follow-up used H/M < 1.60 vs ≥ 1.60 to stratify mortality risk; H/M <1.60 associated with higher mortality.

ReportingDocumentation should specify imaging method (planar vs SPECT), H/M ratio calculation, and scoring methodology to support prognostic claims.

sinus tarsi implant (arthroereisis) definition

Sinus tarsi implant (arthroereisis)A surgical implant placed in the sinus tarsi adjacent to the subtalar joint intended to limit excessive subtalar motion and correct flexible flatfoot deformity.

Implant materialsCommonly titanium or resorbable poly-L-lactic acid (PLLA) devices; often used alone or with adjunct procedures.

Evidence concernsStudies heterogeneous; implant-related pain and variable removal rates reported; routine use not supported by high-quality comparative data.

complication causing implant removal in subtalar arthroereisis studies — sinus tarsi pain

Complication leading to removalSinus tarsi pain: the most common complication reported in subtalar arthroereisis studies and a frequent reason for implant removal (reported removal rate ~29% in one review).

Clinical impactHigh rates of implant-related pain and removal reduce the durability and acceptability of the procedure in some cohorts.

Evidence qualityFindings based on case series and small studies; comparative outcome data lacking.

uRDN definition — ultrasound renal denervation

uRDN definitionUltrasound renal denervation (uRDN): an endovascular procedure delivering focused ultrasound energy (e.g., Paradise system) to renal artery adventitial nerves to reduce sympathetic activity and lower blood pressure.

Procedure detailsParadise system delivers 2–3 doses of 360° ultrasound energy per main renal artery with HydroCooling™ to protect the arterial wall.

Regulatory statusParadise and Symplicity systems received FDA approvals as adjunctive options when lifestyle and medications have not adequately controlled BP.

RSA definition — Radiostereometric analysis explanation

RSA definitionRadiostereometric analysis (RSA): imaging technique using implanted tantalum markers and calibrated biplanar x-rays (through a calibration cage) analyzed with specialized software to compute 3D micromotion between implant and bone.

Use caseRoutinely used in clinical research to measure implant migration and fracture healing with high precision; CT-based RSA being explored.

Clinical limitationEvidence for routine clinical utility is lacking; requires specialized markers, imaging, software, and trained personnel.

BIA definition — Bioelectrical impedance analysis description

BIA definitionBioelectrical impedance analysis (BIA): method that measures electrical impedance of body tissues to estimate total body water, derive fat-free mass, and calculate body fat.

LimitationsResults are sensitive to hydration status, recent fluid intake, and measurement conditions; standardization is required for accuracy.

Policy stanceWhole-body BIA (0358T) is considered unproven and not medically necessary due to inconsistent accuracy and lack of standardized methods.

CLE / pCLE definition — Optical endomicroscopy explanation

CLE / pCLE definitionConfocal laser endomicroscopy (CLE/pCLE): endoscopic technique using fluorescence and confocal imaging (probe-based or integrated) to obtain in vivo microscopic images of mucosa (optical biopsy) to guide targeted biopsies or diagnosis.

ModesProbe-based (pCLE) passed through the endoscope channel or integrated endoscope-based systems providing real-time microscopic imaging during endoscopy.

Clinical contextStudied for biliary strictures, Barrett's esophagus, gastric and colorectal lesions; evidence promising for some indications but overall insufficient for routine replacement of standard biopsy protocols.

CCM definition — Cardiac contractility modulation summary

CCM definitionCardiac contractility modulation (CCM): nonexcitatory electrical signals delivered during the cardiac refractory period via an implanted device intended to enhance myocardial contractility without altering rhythm.

Device/regulatory noteOptimizer system received FDA premarket approval for a narrow NYHA Class III HF subgroup; device recalls and safety advisories have occurred (2025 recall noted).

Evidence contextTrials assess CCM as adjunct to optimal medical therapy; overall policy views CCM as unproven/not medically necessary for chronic HF due to insufficient quality evidence.

OCT definition — Optical coherence tomography description

OCT definitionOptical coherence tomography (OCT): noninvasive imaging using low-intensity light to produce depth-resolved, micron-scale structural images of the middle ear and tympanic membrane, differentiating air from fluid and characterizing fluid scattering properties.

Handheld OCT otoscopePortable OCT configured as an otoscope to image the tympanic membrane and adjacent middle ear structures in outpatient and intraoperative settings.

Evidence noteSmall studies report high diagnostic accuracy for effusion and ability to detect biofilms, but clinical utility and impact on outcomes remain unproven; acquisition failures occur with anatomical/technical limitations.

Middle-ear biofilm definition from CLSM/PCR surgical samples

Middle-ear biofilm definitionClustered bacteria forming a biofilm adherent to the mucosal surface of the tympanic membrane confirmed by confocal laser scanning microscopy (CLSM) and PCR in surgically sampled specimens.

ValidationMonroy et al. (2018) reported CLSM evidence of clustered bacteria in 32 of 33 samples and PCR-detected bacterial DNA in 20 of 31 samples from surgically collected specimens correlated with OCT imaging.

Clinical implicationIdentification of middle-ear biofilms by OCT is investigational; larger studies needed to establish diagnostic utility and outcome benefit.

Handheld OCT otoscope — portable device definition

Handheld OCT otoscopeA portable OCT device configured as an otoscope to capture high-resolution images of the tympanic membrane and middle ear structures for bedside or intraoperative use.

Use casesReported uses include detection of effusion, TM retraction/perforation margins, and postoperative monitoring; image acquisition may fail in narrow canals, otorrhea, cholesteatoma, or poor compliance.

Evidence statusClinical trials are small and device use remains investigational; routine clinical adoption not supported by current evidence.

OpenPayer

Omnibus/new CPT Category III/T codes — coverage conclusions

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Explicitly Not Medically Necessary / Unproven Services

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