Colorado Rocky Mountain Health Plans CPT/HCPCS Coverage

Codes labeled Unproven

Coverage conclusions for listed codes in these chunks

Omnibus code conclusions: Each CPT/HCPCS code listed in these sections is accompanied by the conclusion 'Unproven'.

Applies to all codes listed in the provided chunks

SFDI (0061U) — Not medically necessary

Codes and technologies within these chunks are assessed as follows:

SFDI (0061U): Transcutaneous measurement of biomarkers using spatial frequency domain imaging (SFDI) and multi-spectral analysis (0061U) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

FDA 510(k) clearance exists for the Clarifi Imaging System but clinical outcomes data are insufficient.

Extracranial vertebral artery stenting — Not medically necessary

Extracranial vertebral artery stenting (0075T/0076T): 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 (pooled BASILAR/PERSIST analyses) suggest possible benefit when performed during EVT for PCTL within 24 hours, but evidence is observational and guidelines (ESVS 2023) do not recommend routine stenting; consider revascularization only for recurrent symptoms despite best medical therapy with 50–99% stenosis.

Omnibus unproven codes — Not medically necessary

Numerous listed procedure, device, and supply codes:

Omnibus listed codes: Codes enumerated in these chunks are concluded to be unproven (not medically necessary) except where specifically noted (e.g., 63268 is 'Proven in certain circumstances').

Refer to individual code entries for descriptions and conclusions.

Coverage summaries

Coverage conclusions and criteria based on available evidence and guideline statements in the document:

Extracranial VA stenting during EVT for acute PCTL: Observational registry evidence (Li et al.) suggests association with improved 90-day and 1-year modified Rankin Scale and reduced mortality when extracranial vertebral artery stenting is performed during EVT for posterior circulation tandem lesions treated within 24 hours; evidence is observational, subject to selection bias, and randomized trials are lacking.treatment within 24 hours

Consider only when proceduralist documents anatomy, indication, and risks; guideline caution applies

Vertebral artery stenting for symptomatic stenosis: Randomized trials and systematic reviews (VIST, Cochrane) do not show consistent benefit of endovascular therapy plus medical therapy over medical therapy alone; ESVS 2023 recommends against routine stenting and advises revascularization only for recurrent vertebrobasilar symptoms despite best medical therapy with 50–99% extracranial stenosis.>=50% stenosis with recurrent symptoms despite medical therapy

Coverage may be restricted to patients failing best medical therapy and meeting localization/stenosis criteria

Blood-based biomarker panels — Not medically necessary

Not medically necessary when used for screening:

Blood-based CRC biomarker panels - Not medically necessary: Use of biomarker panel–based algorithmic blood tests (e.g., BeScreened™-CRC testing TDGF-1/Cripto-1, CEA, ECM combined with demographic data) for colorectal cancer or advanced adenoma screening is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Refer to USPSTF and systematic review summaries indicating limited evidence for serum tests in CRC screening.

CAD for chest radiographs — Not medically necessary

Not medically necessary when applied as an adjunctive tool for chest radiograph interpretation:

Chest radiograph CAD - Not medically necessary: Computer-aided detection (CAD) for chest radiographs (0173T-0175T and related AI/CAD) is unproven and not medically necessary due to insufficient evidence that CAD improves diagnostic performance or patient outcomes.

Randomized trial data show no improvement in sensitivity or false-positive rate; guideline assessments call for more research.

Thermal pulsation and wearable eyelid devices — Unproven / Not medically necessary

Coverage stance for eyelid thermal pulsation/wearable heat devices:

Eyelid thermal pulsation/wearable devices - Unproven/Not medically necessary: Thermal pulsation systems (e.g., LipiFlow) and wearable open-eye eyelid heating devices (e.g., TearCare) for evaluation or evacuation of meibomian glands are considered unproven and not medically necessary due to mixed, low-certainty evidence regarding sustained clinical benefit.

Some trials report short-term improvements; professional guidance may list device-based therapy as second-line but evidence is inconsistent and industry funding is common.

Summary of clinical effectiveness and evidence limitations

Evidence-based efficacy summaries and limitations from trials and systematic reviews

Overall evidence: Randomized trials and meta-analyses show vectored thermal pulsation and some wearable devices can improve objective signs (meibomian gland measures, TBUT) and patient-reported symptoms in the short term; some studies report sustained effect up to 12 months after single treatment.

Study quality limited by lack of masking, small samples, heterogeneous endpoints, and manufacturer funding in many trials.

Limitations: Many trials are manufacturer-funded, unmasked or single-center, with short follow-up and inconsistent unit-of-analysis handling (two eyes per participant); systematic reviews call for larger, well-designed RCTs to confirm benefits.

Cochrane and other reviews cite low or very low certainty evidence.

Atherectomy—Not Medically Necessary

Atherectomy of visceral/renal/abdominal/brachiocephalic arteries:

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

Effectiveness and safety versus established treatments have not been demonstrated.

PreTRM—Not Medically Necessary

PreTRM proteomic screening for spontaneous preterm birth:

PreTRM not covered: Use of the PreTRM serum-based proteomic biomarker algorithm (0247U / 81599) to screen asymptomatic pregnant individuals for risk of spontaneous preterm birth is unproven and not medically necessary due to insufficient evidence of clinical benefit; randomized trials have not demonstrated a reduction in sPTB <37 weeks.

Independent validation and further studies required before routine screening use.

Tear film imaging—Not Medically Necessary

Tear film imaging:

Tear film imaging not covered: Tear film imaging modalities (e.g., interferometry, meniscometry, OCT-based tear film imaging; CPT 0330T) to monitor or assess tear film disorders and dry eye are unproven and not medically necessary due to insufficient evidence of safety, repeatability, and clinical utility.

Studies show variable device agreement and correlations with clinical measures but no demonstrated diagnostic performance that changes outcomes; concurrent clinical examination should guide care.

Mobile Audiometry—Conditional/Informational

Mobile and automated audiometry:

Mobile audiometry—evidence summary: Multiple studies and systematic reviews report that some smartphone/tablet apps and automated audiometers can approximate conventional pure-tone audiometry with mean differences generally within clinically acceptable limits (commonly within ±10 dB) and pooled sensitivity/specificity estimates that are promising; however heterogeneity, limited pediatric validation, lack of bone-conduction/masking, and variable device validation limit replacement of formal audiometry.±10 dB considered clinically acceptable

Mobile audiometry may be useful for screening or monitoring where standard PTA is unavailable but should not replace full diagnostic audiometry when clinical decisions require bone conduction or masking.

Tear film imaging — Not medically necessary / Unproven

Tear film imaging coverage determination

Tear film imaging not medically necessary: Tear film imaging (0330T) to monitor or assess tear film disorders is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy; device outputs (LLT, TMH, NIBUT) lack validated diagnostic thresholds and show poor agreement across platforms.

If submitted for review include clinical correlation with slit‑lamp biomicroscopy and conventional tests (TBUT, Schirmer, OSDI).

123I‑MIBG imaging — Not medically necessary / Unproven

123I‑MIBG myocardial sympathetic innervation imaging coverage determination

123I‑MIBG unproven for routine prognostic use: Myocardial 123I‑MIBG imaging (0331T/0332T) is unproven and not medically necessary as a prognostic marker in heart failure because the evidence is largely single-center, uses heterogeneous analytic methods (planar H/M ratio, SPECT scores), and while associated with outcomes, there is insufficient evidence that imaging-based stratification alters management to improve clinical outcomes.H/M example threshold reported: 1.60

Larger multicenter studies and standardized analytic methods are needed before routine use.

Policy decision: Not medically necessary / Unproven

Coverage stance based on evidence synthesis

Not covered — overall conclusion: Sinus tarsi implants/subtalar arthroereisis are unproven and not medically necessary for any indication due to insufficient clinical evidence of safety and/or efficacy, high heterogeneity of studies, and notable complication/removal rates.

NICE recommends use only with special arrangements (governance/consent/audit/research) when considered; routine coverage is not supported.

Evidence limitations: Available studies for subtalar arthroereisis are low quality (case series, nonrandomized), heterogeneous in methods and outcomes, with limited prospective controlled data and variable implant removal rates (reports up to ~48%).

High-quality comparative trials are lacking.

Evidence summary — subtalar arthroereisis and renal denervation

Evidence-based stance and criteria summary from included excerpts

Subtalar arthroereisis evidence: Systematic reviews and HTAs report low-quality evidence for subtalar arthroereisis with inconsistent outcomes and notable implant removal and complication rates; improvements reported but confounding from concomitant procedures and study limitations prevent definitive efficacy conclusions.

Further well-designed comparative trials required.

RDN evidence: Randomized sham-controlled trials and meta-analyses demonstrate modest reductions in ambulatory and office systolic BP for selected renal denervation systems (e.g., RADIANCE II showed −6.3 mmHg daytime ambulatory SBP at 2 months for uRDN vs sham), but heterogeneity of results, short follow-up, and variable patient selection limit long-term conclusions; regulatory approvals exist for specific devices.

Consider RDN only after lifestyle/medical optimization and multidisciplinary evaluation; shared decision-making recommended.

RSA — Coverage determination

Not medically necessary — general statement

RSA not covered: Radiostereometric analysis (RSA) (0347T–0350T) is considered unproven and not medically necessary for routine clinical indications due to insufficient evidence of safety and/or efficacy despite precision in research settings.

RSA requires implantation of tantalum markers and specialized imaging/software; routinely used in research rather than standard clinical care.

Bioelectrical impedance analysis — Coverage determination

Not medically necessary — general statement

Bioelectrical impedance analysis not covered: Bioelectrical impedance analysis whole body composition assessment (0358T) is unproven and not medically necessary due to insufficient evidence of validity and clinical utility across populations.

Accuracy varies with device, equations, hydration and obesity; recommend use for group-level or standardized longitudinal monitoring rather than individual diagnostic decisions.

RSA — clinical stance

RSA is described as promising but limited by technical requirements and need for further validation.

RSA limitations: RSA may provide precise micromotion measurements for implants and fracture healing but requires implantation of tantalum markers, calibrated biplanar radiographs through a calibration cage, dedicated RSA software, and specialized radiographers; operational barriers limit routine adoption and marker-free methods need validation.

Current role is primarily research and phased introduction of implants rather than routine clinical use.

Bioelectrical impedance analysis (BIA) — coverage stance

BIA is generally considered unproven or limited; validity varies by device, population, and conditions.

BIA general conclusions: Bioelectrical impedance analysis (BIA) demonstrates variable agreement with reference methods; accuracy is affected by hydration, predictive equations, obesity, and device heterogeneity. It is unproven as a definitive clinical diagnostic tool and is better suited for group-level assessment or standardized longitudinal monitoring.

Systematic reviews and evaluations conclude limited clinical validity for many populations; standardization and device-specific validation needed.

Electronic brachytherapy — coverage stance

Electronic brachytherapy is unproven for most clinical indications due to limited and low-quality evidence; use is not recommended outside trials/registries for many sites.

Breast cancer: Evidence for electronic brachytherapy in breast APBI is limited and some randomized data report higher recurrence rates; guidance does not support routine use outside trials.

Randomized and long-term comparative data are lacking.

Skin cancer: For nonmelanoma skin cancers evidence is low quality and inconclusive; some bodies recommend use only in registries or trials rather than routine substitution for surgery.

Guideline bodies (ABS, AAD) advise caution and further research.

Gynecologic and other indications: Studies are small, retrospective or single-center and at high risk of bias; evidence does not show superiority over conventional brachytherapy for gynecologic sites and large trials are needed.

ABS and ECRI assessments call for further trials and long-term follow-up before routine adoption.

Indeterminate biliary strictures

Covered when ALL of the following are met

Indeterminate biliary strictures coverage criteria: 1) Indeterminate biliary stricture after standard diagnostic evaluation (e.g., ERCP with tissue sampling) AND 2) CLE (probe-based or endoscope-integrated) used adjunctively with cholangioscopy/ERCP to improve diagnostic accuracy AND 3) Procedure performed by or at a center with documented CLE expertise or documentation supporting clinical necessity and endoscopist proficiency.

Meta-analysis reports pooled pCLE sensitivity ~0.88 and specificity ~0.79; use limited to expert centers or when prior sampling nondiagnostic.

Barrett's esophagus (BE) surveillance / dysplasia

Covered as adjunctive imaging only when specific conditions are met

BE surveillance/dysplasia criteria: 1) CLE is used as an adjunct to high-definition white-light endoscopy (HDWL) and Seattle protocol biopsies in patients at high risk or in expert centers AND 2) Documentation of endoscopist proficiency and rationale for adjunctive imaging (e.g., prior inconclusive biopsies or need for targeted therapy planning).

Guidelines (ASGE/ACG) do not support routine replacement of Seattle protocol; multicenter RCT found no benefit adding pCLE to HDWL for residual BE detection.

Gastric cancer / targeted biopsy

May be considered in select cases

Gastric cancer evaluation: pCLE may be used to target biopsies of suspicious gastric lesions to increase tumor cell yield when performed by experienced operators and when standard endoscopic evaluation is inconclusive; documentation should include indication and prior imaging/endoscopy findings.

Meta-analyses report pooled sensitivity for gastric cancer detection ~87.9% but studies are largely from high-volume Asian centers; generalizability limited.

CLE clinical criteria

CLE / pCLE — evidence summary and coverage implications

CLE utility findings: CLE demonstrates high sensitivity when combined with ERCP for indeterminate biliary strictures (pooled sensitivity ~90%) and shows promising pooled sensitivity/specificity for colorectal and gastric neoplasms; evidence largely from specialized centers and heterogeneous studies limit generalizability.

CLE may increase diagnostic yield in expert settings but cannot replace standard biopsies in routine practice.

BE surveillance evidence: Systematic reviews conclude CLE can detect dysplasia when performed by proficient endoscopists but pCLE does not reliably replace Seattle protocol biopsies; a multicenter RCT found no improvement adding pCLE to HDWL for residual BE detection.

Adjunctive use may be appropriate in expert centers or specific clinical scenarios with documented need.

CCM (Optimizer) — Not medically necessary

Cardiac contractility modulation (CCM) — coverage stance

CCM coverage determination: Cardiac contractility modulation (Optimizer) is considered unproven and not medically necessary for treatment of chronic heart failure due to insufficient quality evidence demonstrating improvements in mortality or HF hospitalizations, despite FDA PMA for a specific subgroup.

If considered, documentation must show FDA-indicated population (NYHA class III, LVEF 25–45%, normal sinus rhythm, not CRT candidate) and prior guideline-directed medical therapy; prior authorization recommended.

CCM FDA-indicated population (context only): Optimizer received FDA approval for NYHA class III patients on guideline-directed medical therapy, in normal sinus rhythm, not CRT candidates, with LVEF 25–45% (context only).LVEF 25% to 45%

Policy stance remains not medically necessary due to evidence gaps.

Percutaneous cryoablation — Not medically necessary

Percutaneous cryoablation for peripheral nerves — coverage stance

Cryoablation for chronic pain: Percutaneous cryoablation/cryoneurolysis of peripheral nerves, nerve plexuses, or truncal nerves (0440T–0442T and related techniques, e.g., iovera°) is unproven and not medically necessary for chronic pain indications due to insufficient and inconsistent clinical evidence.

Randomized trials show short-term benefits in some settings (e.g., knee OA) but effects often diminish and evidence is limited by risk of bias; use generally should be limited to research or selective contexts.

Cryoneurolysis / iovera clinical evidence overview

Evidence summary for cryoneurolysis/iovera indicates:

evidence_overview: Evidence includes randomized sham-controlled trials and nonrandomized studies with limitations; some RCTs show short-term pain and function improvements for knee OA and post-TKA pain but benefits may diminish by 6 months and overall evidence is inconsistent.

Evolving evidence reviews (ECRI, Hayes) report unclear or minimal support and recommend further high-quality trials.

Other cryoneurolysis indications (occipital neuralgia, phantom limb pain)

Pilot and exploratory evidence for other indications:

occipital_and_phantom_pain: Small uncontrolled or pilot studies report short-term pain reduction for indications such as occipital neuralgia and phantom limb pain after cryoneurolysis, but evidence is limited by small size, lack of controls, and potential bias; larger randomized trials are needed.

Considered investigational outside research settings.

OCT otoscopy evidence overview

OCT middle ear evidence and utility:

diagnostic_accuracy: Multiple small studies and case series report high diagnostic accuracy (~90%) for OCT detecting middle ear effusion and biofilms and suggest OCT may influence antibiotic prescribing and management decisions; however studies are small, often device-manufacturer supported, and clinical outcome benefits remain unproven.

Interim RCT data suggest reduced antibiotic prescribing but larger independent trials with clinical outcomes are needed before routine adoption.

Coverage stance — OCT for otitis media

Summary coverage stance based on available evidence in this excerpt

Primary stance: Optical coherence tomography (OCT) of the middle ear (0485T/0486T) is investigational/unproven and not medically necessary for routine diagnosis and management of otitis media or middle-ear biofilms due to limited evidence from small case series and lack of large controlled studies demonstrating improved patient outcomes.

If used, documentation should include imaging attempts, whether images were successfully obtained, and correlation with operative or specimen findings; AAO‑HNS guidelines do not currently endorse OCT for routine OME evaluation.

Prior authorization, documentation, and billing guidance

Prior Authorization

Code listing and prior-authorization overview

All CPT/HCPCS codes and services addressed in this policy section are listed with the policy conclusion for each code. Many listed codes are concluded to be Unproven / Not Medically Necessary; services billed with these codes may be denied. When a code is designated “Proven in certain circumstances” (e.g., 63268 laminectomy for excision/evacuation of intraspinal lesion other than), verify plan-specific prior authorization requirements before scheduling. Prior authorization is expected for requests involving services characterized as unproven or not medically necessary; when prior authorization is not specified in this document, contact the payer for confirmation.

Key unproven / not medically necessary codes are listed throughout the policy (examples: 0061U SFDI, 0100T retinal prosthesis placement — see code list).
Code 63268 is noted as Proven in certain circumstances — check plan-level PA rules and clinical criteria.
When requesting unproven services, include comprehensive documentation (see documentation callouts below) and expect prior authorization or potential denial.

Prior Authorization

Prior authorization expected for unproven services

Specific services and imaging modalities characterized as unproven or not medically necessary in this policy frequently require prior authorization when requested. Examples include transluminal peripheral atherectomy codes (0234T–0237T), PreTRM and other serum-based proteomic algorithmic panels (0247U, 81599), tear film imaging, 123I‑MIBG myocardial innervation imaging, radiostereometric analysis (0347T–0350T), bioelectrical impedance (0358T), electronic brachytherapy (0395T), sinus tarsi implant codes (0335T, 0510T, 0511T, S2117), drug-eluting ocular insert placement (0444T/0445T), middle ear OCT (0485T/0486T), eyelid thermal pulsation and wearable heat devices (0207T, 0563T), retinal prosthesis implantation and programming (0100T, 0472T, 0473T, L8608), CCM device implantation, and renal denervation procedures.

Prior authorization is recommended or expected for the above unproven services; coverage is not supported by the evidence summaries in this policy.
When a device has limited FDA approval/conditions (e.g., Optimizer CCM device indication limits; RDN PMA systems), prior-authorization review should verify that the patient meets the device-specific indications and supporting criteria.
For retinal prostheses and related device programming codes, verify device availability and FDA status; many retinal prosthesis systems remain investigational and manufacturing for some systems (Argus II) has ceased.

Prior Authorization

Prior authorization may apply for proven-in-certain-circumstances codes

Some procedures and technologies reviewed are associated with regulatory approvals or specific guideline‑based indications; these may be approved "in certain circumstances" and therefore prior authorization may be required to confirm indication and documentation. Examples: FDA PMA/PMA-approved renal denervation systems (Paradise, Symplicity Spyral) and CCM Optimizer device (approved for a defined NYHA and LVEF population).

For RDN devices with PMA approval, payer review should confirm conservative therapy attempts, antihypertensive regimen adequacy, and that shared decision‑making and registry/trial enrollment considerations are addressed.
For CCM devices, prior authorization should confirm NYHA class, LVEF range, rhythm (normal sinus), and that CRT is not indicated.
When a code is labeled Proven in certain circumstances, include documentation that all required clinical criteria are met.

Prior Authorization

Prior authorization required for unproven imaging and diagnostics

Some unproven imaging and diagnostic services require prior authorization and additional clinical correlation to support medical necessity when requested. Tear film imaging, 123I‑MIBG myocardial innervation imaging, optical coherence tomography (middle ear), and SFDI are cited as unproven; prior authorization should be obtained and requests should include clinical rationale and prior conservative testing.

Tear film imaging: include conventional diagnostic test results (slit‑lamp biomicroscopy, tear breakup time, ocular surface staining) and clinical correlation in the PA request.
123I‑MIBG imaging: provide HF staging, prior prognostic testing, and how the result would change management.
Middle ear OCT: include guideline-recommended diagnostics (tympanometry, pneumatic otoscopy) and clinical reasoning for OCT use.
SFDI (0061U): submit evidence that standard diagnostic alternatives were considered and why SFDI is necessary.

Note

When prior authorization is not specified

Some sections of the source content did not specify explicit payer-level prior authorization rules. When prior authorization is not specified in the policy text, providers must contact Colorado Rocky Mountain Health Plans to confirm prior‑authorization requirements or submit a clinical determination request.

Examples where no explicit PA guidance is provided: certain eyelid thermal pulsation guidance, wearable device recommendations, and some OCT middle ear studies.
Absence of explicit PA language in the policy does not guarantee coverage — submit a PA or medical review request when clinical uncertainty exists.

Denial Risk

Unproven services — coverage and denial risk

Anticipate denial risk for services characterized as unproven or not medically necessary. Policy conclusions identifying services as Unproven / Not Medically Necessary create a high risk of claim denial unless compelling documentation demonstrates coverage criteria or an exception.

Blood-based colorectal cancer biomarker panels (e.g., 0163U) — denial risk due to insufficient evidence.
Eyelid thermal pulsation and wearable devices (0207T, 0563T) — mixed evidence; some guideline societies list as second‑line or require step therapy; denial risk exists.
PreTRM proteomic preterm birth panel (0247U/81599) — denial risk; considered unproven.
Drug-eluting ocular inserts (0444T/0445T) and middle ear OCT (0485T/0486T) — likely denial without strong evidence of medical necessity.
Electronic brachytherapy (0395T) — potential denial; professional societies advise registry/trial use or deem evidence insufficient.

Documentation Required

Documentation requirements and suggested elements

Documentation expectations: when requesting prior authorization for investigational or conditionally covered services, submit clear clinical rationale, prior conservative therapies, diagnostic test results, imaging and reports, device-specific indication confirmation, informed consent and shared decision‑making notes, and identity of treating specialist. Suggested clinical outcome documentation and technical workflow details are included below to support review.

Suggested documentation elements: clinical history & indication; prior treatments and response (conservative therapy trials); relevant objective test results (e.g., BP recordings and medication history for RDN; LVEF and NYHA class for CCM; tear-film conventional testing for tear imaging); imaging reports and operative notes when device implantation is proposed.
Consent and governance documentation: informed consent describing investigational nature and alternatives; participation in prospective registries or clinical trials when applicable (e.g., electronic surface brachytherapy).
RSA/BIA/OCT technical notes: include acquisition method, calibration, operator qualifications, and how results will change management.
Mobile audiometry and SFDI: include device validation, operator credentials, and clinical correlation with standard tests.
Required documentation when using OCT for middle ear: tympanometry/pneumatic otoscopy results, indication for surgical intervention if applicable, and how OCT findings will alter care.

Step Therapy

Step therapy and conservative-therapy expectations

Stepwise care and conservative‑therapy expectations: many investigational procedures should be considered only after standard, guideline-recommended conservative care has been attempted. Payers will expect documentation of prior therapies and sequencing before authorization of device-based or invasive interventions.

Dry eye / MGD: conventional eyelid hygiene and warm compresses are first-line; TFOS and AAO guidance support thermal pulsation only as second-line in select situations. Provide documentation of prior conservative management before seeking authorization for thermal pulsation or wearable heat devices.
Renal denervation: document lifestyle interventions and adequate trials of antihypertensive pharmacotherapy (three‑drug regimens when applicable) prior to PA for RDN.
Cryoneurolysis / iovera and similar device therapies: expect step‑therapy documentation showing failure of conservative care prior to authorization.

Note

Use with special arrangements (registries, trials)

Special arrangements and trial/registry enrollment: where professional societies or regulatory guidance recommend use only in registries or clinical trials (e.g., electronic surface brachytherapy for skin cancer), documentation of enrollment or intent to enroll and IRB/consent materials should be provided. NICE and other guidance noting special arrangements should be highlighted in requests.

Electronic surface brachytherapy: provide registry/trial enrollment details or institutional review documentation if considering use outside standard surgical options.
When manufacturers or regulatory bodies recommend limited use (e.g., HDE conditions, post‑approval study commitments for retinal prostheses), include evidence of meeting those commitments.

Codes and services requiring prior authorization or special review

Documentation Required

Document indication, prior therapy, and how intervention changes management

When requesting prior authorization or exceptional review for an unproven service, include documentation of indication, prior standard diagnostics or therapies, relevant study details or guidelines, and how results would change patient management.

For vascular interventions (e.g., vertebral artery stenting during EVT), document timing relative to estimated occlusion, anatomy, prior best medical therapy, and registry/trial references when applicable.

Prior Authorization

Prior auth and documentation elements for retinal prosthesis requests

All requests for retinal prosthesis implantation or device programming should undergo prior authorization review given the device status and the policy’s unproven/not medically necessary conclusion; include device availability, HDE criteria if applicable, and post‑approval study compliance in documentation.

Document HDE criteria (age ≥25, bare light/no light perception, prior useful form vision, lens status, ability for follow‑up) if asserting coverage for Argus II.

Documentation Required

Submit clinical rationale and evidence for unproven technologies

Requests for coverage of technologies the policy designates as unproven (e.g., blood‑based CRC panels, CAD for CXR, eyelid thermal pulsation devices) should include clinical rationale and peer‑reviewed evidence; absent strong evidence, these requests may be denied.

Include device/test name, comparator data, trial design, and outcomes when submitting PA for investigational diagnostics or devices.

Prior Authorization

PA review expected for atherectomy, PreTRM, and tear film imaging

Atherectomy (0234T–0237T), PreTRM (0247U/81599), and tear film imaging (0330T) are described as unproven and not medically necessary; prior authorization review for these services should be expected and may result in denial.

When requesting coverage, submit trial data and clear justification for deviation from policy conclusions.

Prior Authorization

Prior authorization required for tear film imaging and 123I‑MIBG

The policy explicitly requires prior authorization for tear film imaging and 123I‑MIBG myocardial sympathetic innervation imaging when requested because both are considered investigational/unproven and not medically necessary without strong justification.

0330T, 0331T, 0332T — include clinical correlation to standard exams and how imaging will alter management in PA submissions.

Prior Authorization

RDN — verify local PA; include BP and medication history

For renal denervation (Paradise, Symplicity), the policy excerpts do not specify payer prior authorization; local payer rules may require authorization for device procedures — verify member plan criteria prior to scheduling.

Document prior antihypertensive therapy attempts, ambulatory BP confirmation, and multidisciplinary evaluation if requesting authorization.

Prior Authorization

PA likely required for BIA and electronic brachytherapy (investigational)

Bioelectrical impedance analysis (0358T) and high‑dose‑rate electronic brachytherapy (0395T) are described as investigational/unproven; prior authorization is likely required and should reflect noncoverage or investigational status.

Provide device/model details and clinical evidence if requesting exceptional coverage for these services.

Prior Authorization

PA recommended for CLE outside expert centers; document proficiency

Confocal laser endomicroscopy (CLE) should be prior‑authorized when requested as adjunctive diagnostic imaging outside documented expert centers or for routine surveillance; documentation should show operator proficiency and prior standard diagnostic steps.

Include evidence of endoscopist CLE training/experience and prior ERCP/Seattle protocol biopsies when applicable.

Prior Authorization

PA to verify FDA‑indicated population for CCM implants

Prior authorization for implantable CCM devices should verify that the patient meets the FDA‑indicated population (NYHA class III, LVEF 25–45%, normal sinus rhythm, not a CRT candidate) and that guideline‑directed medical therapy has been attempted; the policy characterizes CCM as unproven/not medically necessary overall.

PA submissions should include NYHA class documentation, LVEF measurement, rhythm documentation, and prior medical therapy details.

Prior Authorization

PA and exceptional review advised for OCT middle ear and ocular insert codes

The policy indicates OCT middle‑ear (0485T/0486T) and drug‑eluting ocular insert placement (0444T/0445T) are unproven and not medically necessary; prior authorization should be used to reflect noncoverage or require exceptional review with supporting clinical evidence.

When requesting PA, document attempts at standard diagnostics (tympanometry/pneumatic otoscopy) and include operative correlation or specimen confirmation if available.

Key terms and device/test definitions

Unproven — definition

Definition'Unproven' indicates the policy conclusion for the listed code, denoting the procedure or service is not supported by sufficient evidence of safety and/or efficacy and is considered not medically necessary in this policy section.

ImplicationServices coded with codes labeled 'Unproven' may be denied or considered not medically necessary when submitted for coverage.

ScopeApplies to the CPT/HCPCS codes enumerated in the policy table (examples include 0061U, 0075T, 0163U) which are assigned the conclusion 'Unproven'.

Spatial Frequency Domain Imaging (SFDI)

TechniqueSpatial Frequency Domain Imaging (SFDI) is a non-contact optical imaging technique that quantitatively measures superficial tissue biomarkers (e.g., tissue oxygenation StO2, oxy‑ and deoxyhemoglobin) using multi‑spectral analysis.

Device exampleClarifi® Imaging System (Modulated Imaging, Inc.) reports 2D/3D maps of StO2, ctHbO2, ctHbR and related hemoglobin concentrations for superficial tissues.

Intended useIntended as part of a larger assessment battery to characterize superficial tissue perfusion in patients with potential circulatory compromise, not as a standalone diagnostic or treatment decision tool.

Extracranial vertebral artery stenting — definition

DefinitionExtracranial vertebral artery stenting is the transcatheter placement of stent(s) in the extracranial vertebral artery to revascularize stenotic or occluded segments, often performed during endovascular therapy for posterior circulation stroke.

ContextDescribed in registry analyses of posterior circulation tandem lesions (PCTL) treated with EVT; evidence is observational and limited by potential selection bias.

Policy conclusionAssigned conclusion 'Unproven' (not medically necessary) in this policy due to insufficient evidence of efficacy across indications.

PCTL — Posterior circulation tandem lesion

TermPCTL = Posterior circulation tandem lesion (an intracranial posterior circulation occlusion with concomitant extracranial vertebral artery stenosis/occlusion)

Clinical contextPCTLs are considered in studies of EVT where extracranial vertebral artery stenting may be performed during mechanical thrombectomy.

Evidence noteRegistry data suggest potential benefit when treated within 24 hours, but randomized trial evidence is lacking and selection bias may confound results.

Argus II HDE criteria

Device/ApprovalArgus II Retinal Prosthesis System received an FDA Humanitarian Device Exemption (HDE) for select patients with severe to profound retinitis pigmentosa.

HDE criteria (selected)Age ≥25; bare light or no light perception in both eyes (with intact inner retinal function if no light perception); prior useful form vision; ability to comply with post‑implant follow‑up and rehabilitation.

Operational noteManufacturing of Argus II has ceased; post‑approval study commitments included extended follow‑up and multicenter studies per FDA HDE requirements.

BeScreened™‑CRC biomarker panel — definition

Test descriptionBeScreened™‑CRC is an ELISA‑based multiplexed CLIA laboratory‑developed test measuring three plasma/serum proteins (TDGF‑1/Cripto‑1, CEA, ECM) combined with demographic data and a proprietary algorithm to report likelihood of colorectal cancer or advanced adenomas.

Intended useProposed for colorectal cancer screening/advanced adenoma risk assessment as an algorithmic blood‑based biomarker panel.

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

CAD for chest radiographs — definition

DefinitionComputer‑aided detection (CAD) for chest radiographs is a computer algorithm analysis of digital chest x‑ray images that generates adjunctive findings for physician review (codes 0173T‑0175T referenced).

OutputProvides algorithm‑identified candidate lesions or areas of interest as an adjunct to, not a replacement for, radiologist interpretation.

Policy conclusionCAD for chest radiographs is assessed as unproven and not medically necessary due to insufficient evidence that it improves outcomes.

Eyelid thermal pulsation — definition

DefinitionEyelid thermal pulsation refers to device‑based application of localized heat and intermittent pressure (e.g., LipiFlow, iLUX) to evacuate meibomian glands and treat meibomian gland dysfunction (MGD).

ExamplesDevices include LipiFlow Vectored Thermal Pulsation (VTP) and iLUX, intended to improve gland expression and ocular surface parameters.

Evidence noteProfessional guidance lists thermal pulsation as a second‑stage option; randomized and observational studies report mixed results and many are manufacturer‑sponsored.

Vectored thermal pulsation (VTP) — definition

DefinitionVectored thermal pulsation (VTP) is a specific device‑based procedure (e.g., LipiFlow) delivering vectored heat and pulsation to the eyelids to express meibomian glands and treat MGD.

Typical useSingle 12‑minute VTP treatments have been evaluated for short‑ and mid‑term improvement in gland function and symptoms, with some studies reporting effects up to 12 months.

Evidence limitationsKey studies are often unmasked, single‑center, or manufacturer‑funded; independent randomized trials are limited or lacking.

Wearable open‑eye eyelid heat device (TearCare) — definition

DefinitionWearable open‑eye eyelid heat device (TearCare) is a software‑controlled wearable system that delivers targeted, adjustable heat to the tarsal plates/meibomian glands while the eye remains open to facilitate gland expression.

Intended effectDesigned to heat the tarsal plate and meibomian glands to liquefy secretions and facilitate manual/automated gland expression as part of MGD treatment.

Evidence noteAvailable RCTs and observational studies are limited, often manufacturer‑funded, and additional larger blinded trials are needed to confirm comparative effectiveness.

Mobile audiometry / smartphone audiometry — definition

DefinitionMobile audiometry/smartphone audiometry refers to hearing threshold measurement performed using smartphone or tablet applications or software (sometimes with external transducers), intended for self‑ or clinician‑administered screening or monitoring outside conventional audiology booths.

CapabilitiesSome validated apps approximate conventional pure‑tone audiometry with frequency‑specific thresholds generally within ±10 dB in studies; limitations include lack of bone conduction/masking and variable device validation.

Policy stanceMobile audiometry is informational/conditional: promising for screening or monitoring but not a full replacement for clinical pure‑tone audiometry in many settings.

PreTRM test — definition

DefinitionPreTRM is a serum‑based proteomic biomarker test measuring the ratio of IBP4 to SHBG (reported via LC‑MS/MS and combined with clinical data) to stratify risk for spontaneous preterm birth in asymptomatic pregnant individuals.

Intended useProposed as a screening tool to predict risk of spontaneous preterm birth to guide preventive interventions or closer monitoring.

Policy conclusionThe policy designates PreTRM as unproven and not medically necessary for screening due to insufficient evidence of clinical benefit.

Tear film imaging output measures (LLT, TMH, NIBUT)

OutputsTear film imaging devices report measures including Lipid Layer Thickness (LLT), Tear Meniscus Height (TMH), and Non‑invasive Tear Break‑Up Time (NIBUT) as quantitative outputs of tear film characteristics.

Clinical correlationReported LLT, TMH, and NIBUT correlate variably with conventional clinical tests (TBUT, Schirmer, slit‑lamp exam) and devices may not be interchangeable; concurrent clinical assessment is recommended.

Policy stanceTear film imaging is considered unproven and not medically necessary due to limited evidence of diagnostic performance and variable device reproducibility.

Heart/mediastinum (H/M) ratio — definition

DefinitionHeart/mediastinum (H/M) ratio is a semi‑quantitative planar 123I‑MIBG measure comparing myocardial to mediastinal tracer uptake used in prognostic stratification in heart failure studies.

Example thresholdADMIRE‑HF follow‑up reported an H/M threshold of 1.60, with H/M <1.60 associated with higher mortality in cohort analyses; however, clinical utility to guide management remains unproven.

Policy stance123I‑MIBG imaging is designated unproven and not medically necessary as a routine prognostic tool in heart failure because evidence that imaging changes management or improves outcomes is lacking.

Subtalar arthroereisis (SA) — definition

DefinitionSubtalar arthroereisis (SA) is a surgical procedure placing an implant in the sinus tarsi (commonly titanium or resorbable PLLA) to limit excessive subtalar joint motion and correct flexible pes planovalgus (flexible flatfoot).

Indications/contextUsed to treat symptomatic flexible flatfoot after conservative measures have failed; often performed with concomitant procedures in adults and children.

Evidence noteSystematic reviews report low‑quality heterogeneous studies with notable implant removal and complication rates (e.g., implant removal up to ~29% in some series), supporting an unproven policy stance.

Flexible pes planovalgus (flexible flatfoot) — definition

DefinitionFlexible pes planovalgus (flexible flatfoot) is loss of the medial longitudinal arch with forefoot abduction and subtalar eversion; it may be symptomatic or asymptomatic and addressed with conservative or surgical options.

Clinical managementInitial management includes conservative measures (rest, orthotics, physical therapy); surgery considered when symptomatic and refractory to conservative therapy.

Relation to arthroereisisSubtalar arthroereisis is one surgical approach intended to limit excessive subtalar motion in flexible flatfoot but is considered unproven by this policy due to low‑quality evidence and complication/removal concerns.

Subtalar arthroereisis — definition

DefinitionSubtalar arthroereisis refers to surgical insertion of a sinus tarsi implant (arthroereisis) intended to limit excessive subtalar motion and correct flexible flatfoot deformity.

Implant typesImplants are commonly titanium or resorbable poly‑L‑lactic acid (PLLA) materials and may be used alone or with additional reconstructive procedures.

Policy/complication noteAvailable studies are low quality and report substantial rates of sinus tarsi pain and implant removal, contributing to the policy's 'not medically necessary' position.

Renal denervation (RDN) — definition

DefinitionRenal denervation (RDN) is a catheter‑based procedure (radiofrequency or ultrasound) that ablates renal sympathetic nerves to reduce sympathetic drive and lower blood pressure in patients with resistant hypertension.

Devices/examplesExamples include the Paradise™ Ultrasound Renal Denervation system (PMA) and the Symplicity Spyral™ Renal Denervation System (PMA); regulatory clearances exist for specific systems.

Evidence noteRandomized sham‑controlled trials demonstrate modest BP reductions for some devices, but guidance and evidence summaries recommend continued evaluation; patient selection and multidisciplinary assessment are emphasized.

Radiostereometric analysis (RSA) — definition

DefinitionRadiostereometric analysis (RSA) is a technique using implanted tantalum markers and calibrated biplanar x‑rays analyzed with RSA software to calculate 3‑D micromotion (maximal total point motion) between implant and bone for precise assessment of implant migration or fracture healing.

Technical requirementsRequires implantation of small tantalum markers, postop biplanar x‑rays through a calibration cage, specialized RSA software, and trained radiographers; CT‑based RSA methods are being explored in research.

Policy noteRoutinely used in research but considered unproven and not medically necessary for routine clinical use due to limited evidence of clinical utility and operational barriers.

Bioelectrical impedance analysis (whole body composition) — definition

DefinitionBioelectrical impedance analysis (BIA) estimates whole‑body composition noninvasively by measuring electrical impedance to derive total body water, fat‑free mass, and fat mass; code 0358T describes whole body composition assessment with interpretation and report.

LimitationsAccuracy and clinical validity vary by device, population, hydration status, predictive equations, and obesity; recommended primarily for group‑level or standardized longitudinal monitoring rather than definitive individual diagnosis.

Policy stanceBIA whole body composition assessment is designated unproven and not medically necessary due to insufficient evidence of clinical benefit.

Electronic brachytherapy — definition

DefinitionElectronic brachytherapy uses a miniaturized X‑ray source to deliver high‑dose radiation internally or adjacent to target tissues as an alternative to radionuclide brachytherapy.

ApplicationsInvestigationally used for skin, breast, endometrial, cervical, and other sites; aims to avoid radionuclide source handling and waste.

Policy stanceConsidered unproven and not medically necessary for most indications due to limited and low‑quality evidence; recommended only in trials/registries per evidence assessments.

Confocal laser endomicroscopy (CLE) / optical endomicroscopy — definition

DefinitionConfocal laser endomicroscopy (CLE), also called optical endomicroscopy or optical biopsy, is an endoscopic technique (probe‑based or integrated) using blue laser light and fluorescein to obtain high‑resolution in vivo microscopic images of the mucosal layer during endoscopy.

ModalitiesIncludes probe‑based CLE (pCLE) inserted via the endoscope accessory channel and endoscope‑integrated CLE systems for real‑time optical histology.

Clinical roleCLE can augment diagnostic evaluation (e.g., biliary strictures, gastric/colorectal lesions, Barrett's esophagus) when performed by experienced operators, but routine replacement of standard biopsy protocols is not supported by current evidence.

pCLE — definition

DefinitionpCLE (probe‑based confocal laser endomicroscopy) is a CLE modality delivered via a probe passed through the endoscope accessory channel to provide in‑vivo microscopic imaging for real‑time assessment and targeting of biopsies.

PerformanceMeta‑analyses report high pooled sensitivity for select indications (e.g., biliary strictures sensitivity ~88–90%) but study heterogeneity and center expertise limit generalizability.

Policy implicationpCLE may be considered adjunctive in expert centers for indeterminate biliary strictures or targeted biopsy but is not recommended as routine surveillance or replacement of Seattle protocol for Barrett's esophagus.

CCM — definition

DefinitionCardiac contractility modulation (CCM) is therapy delivered via an implanted pulse generator and leads that provide non‑excitatory electrical signals during the absolute refractory period to enhance myocardial contractility.

Device/exampleOptimizer™ implantable CCM system (FDA PMA P180036) is indicated for select NYHA class III patients with LVEF 25–45%, in normal sinus rhythm, not indicated for CRT.

Policy stanceDespite FDA approval for a specific subgroup, CCM is considered unproven and not medically necessary in this policy due to evidence gaps in long‑term outcomes and overall quality concerns.

Iovera° system (cryoneurolysis) — definition

DefinitionIovera° system is an FDA‑cleared cryoneurolysis system that applies targeted cold to peripheral nerves to produce analgesic lesions; indicated for relief of knee osteoarthritis (up to ~90 days) and to facilitate target nerve localization with compatible stimulators.

MechanismDelivers freezing cold to peripheral nerves to block pain transmission temporarily via cryoneurolysis.

Evidence noteRandomized sham‑controlled trials show short‑term benefit for knee OA and post‑TKA pain but long‑term efficacy and broader indications require further study; policy characterizes cryoneurolysis as unproven for many peripheral indications.

OCT otoscope — definition

DefinitionOCT otoscope is a handheld, noninvasive optical coherence tomography device configured as an otoscope to produce micron‑scale, depth‑resolved cross‑sectional images of the tympanic membrane and middle ear.

Potential findingsCan detect middle‑ear effusion, tympanic membrane thickness, and TM‑adherent biofilms in small studies, providing depth‑resolved structural information not visible with standard otoscopy.

Policy stanceOCT otoscopy shows promising diagnostic accuracy in small studies but is considered investigational/unproven for routine management of otitis media pending larger trials demonstrating clinical utility and outcome benefit.

0061U	Transcutaneous measurement of five biomarkers using spatial frequency domain imaging (SFDI) and multi-spectral analysis
0075T	Transcatheter placement of extracranial vertebral artery stent(s); initial vessel
0076T	Transcatheter placement of extracranial vertebral artery stent(s); each additional vessel
0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy
0163U	Oncology (colorectal) screening ELISA of 3 plasma/serum proteins with proprietary algorithm
0174T	Computer-aided detection (CAD) of chest radiograph(s), concurrent with primary interpretation
0175T	Computer-aided detection (CAD) of chest radiograph(s), remote from primary interpretation
0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
0208T	Pure tone audiometry (threshold), automated; air only
0209T	Pure tone audiometry (threshold), automated; air and bone

OpenPayer

Omnibus/new CPT/HCPCS codes (coverage stance)

Coverage determinations and evidence summaries

CPT / HCPCS code listings and statuses

Situations where use may be considered medically necessary

Prior authorization, documentation, and billing guidance

Codes and services requiring prior authorization or special review

Explicit not-covered statements

Key terms and device/test definitions

Frequency and use limitations

Contrast and adjunctive agent guidance

Policy background and scope

Policy revision history