Experimental/Investigational services are defined as a treatment, procedure, facility, equipment, drug, service or supply (“intervention”) that has been determined not to be medically effective for the condition being treated.
This policy addresses services considered to be experimental/investigational and, therefore, non-covered services.
Services meeting ANY of the following criteria are considered experimental/investigational:
Procedure codes identified within this policy are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of these services cannot be established by the available published peer-reviewed literature.
Nervous System
Procedure Code |
Description |
A4593 |
Neuromodulation stimulator system, adjunct to rehabilitation therapy regime |
A4594 |
Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each |
Eye
Procedure Code |
Description |
66683 |
Iris prosthesis Implantation |
92145 |
Corneal hysteresis determination, by air impulse stimulation, unilateral or bilateral, with interpretation and report |
95919 |
Quantitative pupillometry with physician or other qualified health care professional interpretation and report, unilateral or bilateral |
C1839 |
Iris prosthesis |
L8608 |
Miscellaneous external component, supply or accessory for use with the Argus II retinal prosthesis system |
Face, Head and Neck
Procedure Code |
Description |
93896 |
Vasoreactivity study of intracranial arteries performed with transcranial Doppler |
97007 |
Mechanical scalp cooling, including individual cap supply with head measurement, fitting, and patient education |
97008 |
Mechanical scalp cooling; including hair preparation, individual cap placement, therapy initiation, and precooling period |
97009 |
Mechanical scalp cooling; provided after discontinuation of chemotherapy, each 30 minutes (List separately in addition to code for primary procedure) |
Ear, Nose and Throat
Procedure Code |
Description |
30469 |
Repair of nasal valve collapse with low energy, temperature-controlled (ie, radiofrequency) subcutaneous/submucosal remodeling |
Respiratory System
Procedure Code |
Description |
C1601 |
Endoscope, single-use (i.e. disposable), pulmonary, imaging/illumination device (insertable) |
K1037 |
Docking station for use with oral device/appliance used to reduce upper airway collapsibility |
Gastrointestinal System
Procedure Code |
Description |
91022 |
Duodenal motility (manometric) study |
A4563 |
Rectal control system for vaginal insertion, for long term use, includes pump and all supplies and accessories, any type each |
A9268 |
Programmer for transient, orally ingested capsule |
A9269
|
Programable, transient, orally ingested capsule, for use with external programmer, per month |
C1748 |
Endoscope, single-use (i.e. disposable), upper GI, imaging/illumination device (insertable) |
C9779 |
Endoscopic submucosal dissection (ESD), including endoscopy or colonoscopy, mucosal closure, when performed |
C9901 |
Endoscopic defect closure within the entire gastrointestinal tract, including upper endoscopy (including diagnostic, if performed) or colonoscopy (including diagnostic, if performed), with all system and tissue anchoring components |
Skin and Subcutaneous Tissue
Procedure Code |
Description |
96931 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report, first lesion |
96932 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, first lesion |
96933 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, first lesion |
96934 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition and interpretation and report, each additional lesion (list separately in addition to code for primary procedure) |
96935 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; image acquisition only, each additional lesion (list separately in addition to code for primary procedure) |
96936 |
Reflectance confocal microscopy (RCM) for cellular and sub-cellular imaging of skin; interpretation and report only, each additional lesion (list separately in addition to code for primary procedure) |
C1832 |
Autograft suspension, including cell processing and application, and all system components |
C8002 |
Preparation of skin cell suspension autograft, automated, including all enzymatic processing and device components (do not report with manual suspension preparation) |
Cardiovascular System
Procedure Code |
Description |
33267 |
Exclusion of left atrial appendage, open, any method (i.e., excision, isolation via stapling, oversewing, ligation, plication, clip) |
33268 |
Exclusion of left atrial appendage, open, performed at the time of other sternotomy or thoracotomy procedure(s), any method (i.e., excision, isolation via stapling, oversewing, ligation, plication, clip) (list separately in addition to code for primary procedure) |
33269 |
Exclusion of left atrial appendage, thoracoscopic, any method (i.e., excision, isolation via stapling, oversewing, ligation, plication, clip) |
33440 |
Replacement, aortic valve; by translocation of autologous pulmonary valve and transventricular aortic annulus enlargement of the left ventricular outflow tract with valved conduit replacement of pulmonary valve (Ross-Konno procedure) |
64654 |
Initial open implantation of baroreflex activation therapy (BAT) modulation system, including lead placement onto the carotid sinus, lead tunnelling, connection to a pulse generator placed in a distant subcutaneous pocket (ie, total system), and intraoperative interrogation and programming |
64655 |
Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; lead only |
64656 |
Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; pulse generator only |
64657 |
Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator |
64658 |
Removal of baroreflex activation therapy (BAT) modulation system; lead only |
64659 |
Removal of baroreflex activation therapy (BAT) modulation system; pulse generator only |
75577 |
Quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease, derived from augmentative software analysis of the data set from a coronary computed tomographic angiography, with interpretation and report by a physician or other qualified health care professional |
93145 |
Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); without programming |
|
|
93146 |
Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming, including optimization of tolerated therapeutic level setting |
93895 |
Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral |
C1736 |
Catheter(s), intravascular for renal denervation, ultrasound, including all single use system components |
C1825 |
Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s) |
C7568 |
Catheter placement in coronary artery(ies) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation, with intravascular doppler velocity and/or pressure derived coronary flow reserve measurement (initial coronary vessel or graft) during coronary angiography including pharmacologically induced stress |
C7569 |
Percutaneous transluminal coronary angioplasty, single major coronary artery or branch with endoluminal imaging of initial coronary vessel or graft using intravascular ultrasound (ivus) or optical coherence tomography (oct) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report |
C7570 |
Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with intraprocedural coronary fractional flow reserve (ffr) with 3d functional mapping of color-coded ffr values for the coronary tree, derived from coronary angiogram data, for real-time review and interpretation of possible atherosclerotic stenosis(es) intervention (list separately in addition to code for primary procedure) |
C7571 |
Percutaneous transluminal coronary angioplasty, single major coronary artery or branch with percutaneous transluminal coronary lithotripsy |
C8004 |
Simulation angiogram with use of a pressure-generating catheter (e.g., one-way valve, intermittently occluding), inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the angiogram, for subsequent therapeutic radioembolization of tumors |
C9758 |
Blinded procedure for NYHA class III/IV heart failure; transcatheter implantation of interatrial shunt or placebo control, including right heart catheterization, trans-esophageal echocardiography (tee)/intracardiac echocardiography (ice), and all imaging with or without guidance (e.g., ultrasound, fluoroscopy), performed in an approved investigational device exemption (ide) study |
C9759 |
Transcatheter intraoperative blood vessel microinfusion(s) (i.e., intraluminal, vascular wall and/or perivascular) therapy, any vessel, including radiological supervision and interpretation, when performed |
C9760 |
Non-randomized, non-blinded procedure for nyha class II, III, IV heart failure; transcatheter implantation of interatrial shunt, including right and left heart catheterization, transeptal puncture, trans-esophageal echocardiography (tee)/intracardiac echocardiography (ice), and all imaging with or without guidance (i.e., ultrasound, fluoroscopy), performed in an approved investigational device exemption (IDE) study |
C9780 |
Insertion of central venous catheter through central venous occlusion via inferior and superior approaches (i.e., inside-out technique), including imaging guidance |
C9782 |
Blinded procedure for New York Heart Association (NYHA) class ii or iii heart failure, or Canadian cardiovascular society (ccs) class iii or iv chronic refractory angina; transcatheter intramyocardial transplantation of autologous bone marrow cells (e.g., mononuclear) or placebo control, autologous bone marrow harvesting and preparation for transplantation, left heart catheterization including ventriculography, all laboratory services, and all imaging with or without guidance (e.g., transthoracic echocardiography, ultrasound, fluoroscopy), performed in an approved investigational device exemption (ide) study |
C9783 |
Blinded procedure for transcatheter implantation of coronary sinus reduction device or placebo control, including vascular access and closure, right heart catheterization, venous and coronary sinus angiography, imaging guidance and supervision and interpretation when performed in an approved investigational device exemption (ide) study |
C9793 |
3D predictive model generation for pre-planning of a cardiac procedure, using data from cardiac computed tomographic angiography with report |
K1030 |
External recharging system for battery (internal) for use with implanted cardiac contractility modulation generator, replacement only |
Q0035 |
Cardiokymyography (CKG) |
S3902 |
Ballistocardiogram |
S9025 |
Omnicardiogram/cardiointegram |
Musculoskeletal System
Procedure Code |
Description |
77089 |
Trabecular bone score (tbs), structural condition of the bone microarchitecture; using dual x-ray absorptiometry (dxa) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture-risk |
77090 |
Trabecular bone score (tbs), structural condition of the bone microarchitecture; technical preparation and transmission of data for analysis to be performed elsewhere |
77091 |
Trabecular bone score (tbs), structural condition of the bone microarchitecture; technical calculation only |
77092 |
Trabecular bone score (tbs), structural condition of the bone microarchitecture; interpretation and report on fracture-risk only by other qualified health care professional |
97037 |
Low-level laser therapy for post-operative pain reduction |
C1734 |
Orthopedic/device/drug matrix for opposing bone-to-bone or soft tissue-to bone (implantable) |
C1762 |
Connective tissue, human (includes fascia lata) |
C8003 |
Implantation of medial knee extraarticular implantable shock absorber spanning the knee joint from distal femur to proximal tibia, open, includes measurements, positioning and adjustments, with imaging guidance (eg, fluoroscopy) |
E3200 |
Gait modulation system, rhythmic auditory stimulation, including restricted therapy software, all components and accessories, prescription only |
S2348 |
Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple |
L8701 |
Powered upper extremity range of motion assist device, elbow, wrist, hand with single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated |
L8702 |
Powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated |
M0076 |
Prolotherapy |
Endocrine System
Procedure Code |
Description |
Injection
Procedure Code |
Description |
Genitourinary System
Procedure Code |
Description |
52284 |
Cystourethroscopy, with urethral mechanical dilation and drug delivery by drug-coated balloon catheter |
53451 |
Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance |
53452 |
Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance |
53453 |
Periurethral transperineal adjustable balloon continence device; removal, each balloon |
53454 |
Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume |
57465 |
Computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect (list separately in addition to code for primary procedure) |
E2001 |
Suction pump, home model, portable or stationary, electric, any type, for use with external urine management system and/or fecal management |
Miscellaneous
Procedure Code |
Description |
36837 |
Percutaneous arteriovenous fistula creation, upper extremity, separate access sites of the peripheral artery and peripheral vein, including fistula maturation procedures (e.g., transluminal balloon angioplasty, coil embolization) when performed, including all vascular access, imaging guidance and radiologic supervision and interpretation |
C8000 |
Support device, extravascular, for arteriovenous fistula (implantable) |
C9807 |
Nerve stimulator, percutaneous, peripheral (e.g., sprint peripheral nerve stimulation system), including electrode and all disposable system components, non-opioid medical device (must be a qualifying medicare non-opioid medical device for post-surgical pain relief in accordance with section 4135 of the caa, 2023) |
C9810 |
Water circulating motorized cold therapy device (e.g., iceman) including all system components (e.g. pads, console, disposable parts), non-opioid medical device (must be a qualifying medicare non-opioid medical device for post-surgical pain relief in accordance with section 4135 of the caa, 2023) |
E0683 |
Non-pneumatic, non-sequential, peristaltic wave compression pump |
E0767 |
Intrabuccal, systemic delivery of amplitude-modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories |
E3000 |
Speech volume modulation system, any type, including all components and accessories |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475
, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697
(TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association. Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania. Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York]. All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
