Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Experimental/Investigational Services

Policy #:12.01.01ar

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

This policy addresses those specific services that are determined by the Company to be experimental/investigational based on the definition in the Company's benefit contracts. The services that are listed in Attachments A, B, and C are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these services cannot be established by review of the available published peer-reviewed literature.

The list of services in Attachments A, B, and C are not all-inclusive. Attachments A, B, and C do not list those services determined by the Company to be experimental/investigational that are contained in a separate medical policy. Additions and deletions will be made as changes occur or if the experimental/investigational status of a service changes. The services that are listed do not include services that have split-coverage decisions based on criteria.

The following is a summary of the definition of the terms experimental/investigational and experimental/investigative, found in benefit contracts. For the purposes of this policy, experimental/investigational will be the preferred term and will be used throughout this document. This summary is provided for illustrative purposes only. Please consult the applicable health benefit plan contract for the specific definition of experimental/investigational.

The term experimental/investigational is used to describe services that address a drug, biological product, device, medical treatment, diagnostic test, or procedure that meets any of the following criteria:
  • Is the subject of ongoing Clinical Trials;
  • Is the research, experimental, study, or investigational arm of an ongoing Clinical Trial(s) or is otherwise under a systematic, intensive investigation to determine its maximum tolerated dose, its toxicity, its safety, its effectiveness, or its effectiveness as compared with a standard means of treatment or diagnosis;
  • Is not of proven benefit for the particular diagnosis or treatment of the Covered Person’s particular condition;
  • Is not generally recognized by the medical community, as clearly demonstrated by Reliable Evidence, as effective and appropriate for the diagnosis or treatment of the Covered Person’s particular condition;
  • Is generally recognized, based on Reliable Evidence, by the medical community, as a diagnostic or treatment intervention for which additional study regarding its safety and effectiveness for the diagnosis or treatment of the Covered Person’s particular condition is recommended.

The term Reliable Evidence is used to describe peer-reviewed reports of clinical studies that have been designed according to accepted scientific standards such that potential biases are minimized to the fullest extent, and generalizations may be made about safety and effectiveness of the technology outside of the research setting. Studies are to be published or accepted for publication in medical or scientific journals that meet nationally recognized requirements for scientific manuscripts and that are generally recognized by the relevant medical community as authoritative. Furthermore, evidence-based guidelines from respected professional organizations and governmental entities may be considered Reliable Evidence if generally accepted by the relevant medical community.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, services listed in Attachment A are not eligible for payment under the medical benefits of the Company’s products because the services are considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Description

Experimental and investigational services (e.g., devices, drugs, procedures, supplies, technologies, treatments) are services whose safety or efficacy is not known, or are services that are used in a way that departs from generally accepted standards of practice in the medical community.
References


Company Benefit Contracts.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

See Attachments A, B and C


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

See Attachments A, B and C


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Experimental/Investigational Services
Description: Experimental/Investigational Services Represented by a Specific Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) Code.

Attachment B: Experimental/Investigational Services
Description: Experimental/Investigational Services without a Specific Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) Code.

Attachment C: Experimental/Investigational Services
Description: Experimental/Investigational services with a specific Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) Code, that are reported for other services.




Policy History

Revisions from 12.01.01ar:
01/01/2019The following CPT codes are considered Experimental/Investigational and have been added to Attachment A of this policy: 33274, 33289, 53854, 64632, 64640, 83722, 93264, 0511T, 0512T, 0513T, 0514T, 0515T, 0516T, 0517T, 0519T, 0520T, 0521T, 0522T, 0523T, 0525T, 0526T, 0527T, 0528T, 0529T, 0533T, 0534T, 0535T, 0536T, 0541T, 0542T, 0080U, 0083U

The following CPT codes have been termed and have been removed from Attachment A of this policy: 0159T, 0195T, 0196T, 0337T, 0387T, 0388T, 0389T, 0390T, 0391T

The following CPT code has been removed from Attachment A of this policy because it is considered Medically Necessary: 83993

The following CPT narrative has been revised in Attachment A of this policy: 0335T

The following HCPCS codes are considered Experimental/Investigational and have been added to Attachment A of this policy: A4563, C8937, C9751, C9752, C9753, L8701, L8702

The following HCPCS codes have been termed and have been removed from Attachment A of this policy: C9741, C9748, C9750

The following HCPCS code has been removed from Attachment A of this policy because it is considered Medically Necessary: A9584

The following HCPCS code has been removed from Attachment A of this policy because its coverage position is now communicated in MP 08.00.18 Nutritional Formulas, Enteral Nutrition, Medical Foods, Low-Protein Modified Food Products, and Donated Breast Milk: Q9994

The following service is represented by unlisted code 19499 and is considered Experimental/Investigational, and has been added to Attachment B of this policy:
  • Use of the Savi Scout Surgical Guidance System

The following services are represented by unlisted code 64999 and are considered Experimental/Investigational, and have been added to Attachment B of this policy:
  • Spenopalatine ganglion (SPG) block
  • Use of the Tx360® Nasal Applicator
  • Use of the SphenoCath®

The following services are represented by unlisted code E1399 and are considered Experimental/Investigational, and have been added to Attachment B of this policy:
  • Freespira®
  • Savi Scout Surgical Guidance System
  • Tx360® Nasal Applicator
  • SphenoCath®

The following services are represented by unlisted code 28899 and have been removed from Attachment B of this policy because they are now reported with CPT codes 0512T and 0513T:
  • Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; initial wound
  • Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; each additional wound (List separately in addition to code for primary procedure)

The following service represented by CPT codes 90875, 90876, and 90901 is considered Experimental/Investigational, and has been added to Attachment C of this policy:
  • Biofeedback using capnometry guided respiratory intervention (CGRI) (e.g., Freespira®)

Revisions from 12.01.01aq:
10/01/2018The following CPT codes are considered Experimental/Investigational and have been added to Attachment A of this policy: 0062U, 0063U, 0066U

The following HCPCS code is considered Experimental/Investigational and has been added to Attachment A of this policy: C9750

The following services are represented by unlisted code 19499 and are considered Experimental/Investigational, and have been added to Attachment B of this policy:
  • Radiofrequency Spectroscopy
  • MarginProbe®
  • Handheld Radiofrequency Spectroscopy

The following CPT code is considered Medically Necessary and has been removed from Attachment A of this policy: 55874

The following HCPCS code is considered Medically Necessary and has been removed from Attachment A of this policy: S2107

Revisions from 12.01.01ap:
07/23/2018The following CPT codes have been removed from Attachment A of this policy because their Experimental/Investigational coverage position is communicated in Medical Policy 07.02.21 Ambulatory Electrocardiography (AECG) Monitoring and Mobile Cardiac Outpatient Telemetry (MCOT) Monitoring: 0497T, 0498T

The following diagnostic tests are considered Experimental/Investigational and have been added to Attachment B of this policy:
  • WATS3D® by CDx® Diagnostics™
  • OralCDx® Brush Biopsy (or Brush Test®) by CDx® Diagnostics™
  • EndoCDx® TNE: Transnasal Esophagoscopy (or EndoCDx® brush biopsy) by CDx® Diagnostics™
  • EndoCDx® LP - Laryngeal (or Transepithelial Laryngeal Brush Biopsy) by CDx® Diagnostics™

Revisions from 12.01.01ao:
07/01/2018The following CPT codes have been added to Attachment A of this policy: 0333T, 0506T, 0507T, 0052U, 0061U

Code B9998, used to report Relizorb, has been deleted from Attachment B of this policy, and replaced with HCPCS code Q9994 in Attachment A.

Revisions from 12.01.01an:
04/01/2018The following CPT codes have been added to Attachment A of this policy: 62280, 62281, 62282, 62292

On 03/29/2018 the policy in Notification was updated with medical codes effective 04/01/2018.

The following CPT codes are considered Experimental/Investigational, and have been added to Attachment A of this policy:
  • 0497T
  • 0498T
  • 0043U
  • 0044U

The following HCPCS code is considered Experimental/Investigational, and has been added to Attachment A of this policy:
  • C9749

The following CPT code has been removed from Attachment A of this policy because its coverage position is communicated in Medical Policy 05.00.39 Ankle-Foot/Knee-Ankle-Foot Orthoses:
  • A9285

The following CPT code has been removed from Attachment A of this policy:
  • 27279

Revisions from 12.01.01am:
01/01/2018This version of the policy will become effective 01/01/2018.

This policy has been identified for the CPT / HCPCS code update.

The following CPT codes have been added to Attachment A of this policy: 64912, 64913, 0483T, 0484T, 0485T, 0486T, 0487T, 0489T, 0490T, 0491T, 0492T, 0493T, 0499T, 0024U, 0025U

The following HCPCS code has been added to Attachment A of this policy: C9748

The following CPT code has been removed from Attachment A of this policy and is replaced by the following CPT code:
    REMOVED: 0438T
    REPLACED WITH: 55874

The following CPT codes have been removed from Attachment A of this policy and are replaced by the following NOC code (in Attachment B):
    REMOVED: 0178T, 0179T, 0180T
    REPLACED WITH: 93799

The following CPT codes have been removed from Attachment A of this policy and are replaced by the following NOC code (in Attachment B):
    REMOVED: 0299T, 0300T
    REPLACED WITH: 28899

The following CPT code has been removed from Attachment A of this policy and is replaced by the following NOC code (in Attachment B):
    REMOVED: 0301T
    REPLACED WITH: 19499

The following CPT code has been removed from Attachment A of this policy and is replaced by the following NOC code (in Attachment B):
    REMOVED: 0309T
    REPLACED WITH: 22899

The following CPT code has been removed from Attachment A of this policy and is replaced by the following NOC code (in Attachment B):
    REMOVED: 0310T
    REPLACED WITH: 64999

The following CPT codes have been termed and removed from Attachment A of this policy: 0255T, 0293T, 0294T, 0302T, 0303T, 0304T, 0305T, 0306T, 0307T

The following CPT narrative has been revised in Attachment A of this policy: 0254T

The following service is represented by unlisted code 43499 and is considered Experimental/Investigational, and has been added to Attachment B of this policy: Per-Oral Endoscopic Myotomy (POEM)

The following service is represented by unlisted codes 44799 and 45399 and is considered Experimental/Investigational, and has been added to Attachment B of this policy: Chromoendoscopy

The following service is represented by unlisted code 69799 and is considered Experimental/Investigational, and has been added to Attachment B of this policy: Balloon dilation of eustachian tube

The following services represented by CPT code 83516 are considered Experimental/Investigational, and have been added to Attachment C of this policy:
  • InflammaDry
  • Matrix Metalloproteinase-9 (MMP-9) when used as an inflammatory marker to detect dry eye disease


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/22/2019
Version Reissued Date: N/A

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