The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. As used by Carelon, the Guidelines establish objective and evidence-based criteria for medical necessity determinations where possible. In the process, multiple functions are accomplished:

To establish criteria for when services are medically necessary (i.e., in general, shown to be effective in improving health outcomes and considered the most appropriate level of service)
To assist the practitioner as an educational tool
To encourage standardization of medical practice patterns
To curtail the performance of inappropriate and/or duplicate services
To advocate for patient safety concerns
To enhance the quality of health care
To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Relevant citations are included in the References section attached to each Guideline. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website twenty-four hours a day, seven days a week. Copies of the Carelon Clinical Appropriateness Guidelines are also available upon oral or written request. Although the Guidelines are publicly-available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

Providers may be required to submit clinical documentation in support of a request for services. Such documentation must a) be current enough to accurately reflect the clinical situation at the time of the requested service, and b) contain the elements necessary to determine compliance with guideline criteria without Carelon physician reviewers having to make assumptions or interpretations about an ordering provider’s clinical intent.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would supersede the requirements set forth above. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing at the same facility due to technical issues
Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered. For situations wherein ongoing services might be appropriate, requests for subsequent services may be denied until completion of the previously authorized services so that patient response to the previously authorized services can be considered.

Description

This guideline addresses healthcare interventions defined as drugs, devices, tests, and medical or surgical procedures that are not otherwise addressed by a more specific or relevant Carelon clinical guideline.

This guideline can be used for both Adult and Pediatric patients. See the coding section for a noninclusive list of codes included in this guideline.

Clinical Indications

A healthcare intervention is considered medically necessary when it meets the elements of Carelon’s clinical appropriateness framework including ALL of the following:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

References

Agency for Healthcare Research and Quality. Methods Guide for Medical Test Reviews. AHRQ Publication No. 12-EC017. Rockville, MD: Agency for Healthcare Research and Quality; 2012. p. 188.
American Medical Association. Specialty Guide: Pathology. Chicago, IL: American Medical Association; 2020. p. 4.
BMJ Best Practice. EBM Toolkit: What is GRADE? United Kingdom: BMJ Publishing Group Limited; 2023. https://bestpractice.bmj.com/info/us/toolkit/learn-ebm/what-is-grade/
Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Medical decision making : an international journal of the Society for Medical Decision Making. 1991;11(2):88-94.
Gazelle GS, Kessler L, Lee DW, et al. A framework for assessing the value of diagnostic imaging in the era of comparative effectiveness research. Radiology. 2011;261(3):692-8.
Herndon JH, Hwang R, Bozic KJ. Healthcare technology and technology assessment. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2007;16(8):1293-302.
Institute of Medicine (US) Committee for Evaluating Medical Technologies in Clinical Use. Assessing Medical Technologies. 3, Methods of Technology Assessment. Washington (DC): National Academies Press (US); 1985.
Lee DW, Neumann PJ, Rizzo JA. Understanding the medical and nonmedical value of diagnostic testing. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2010;13(2):310-4.
Singal AG, Higgins PD, Waljee AK. A primer on effectiveness and efficacy trials. Clinical and translational gastroenterology. 2014;5:e45.
Slomiany M, Madhavan P, Kuehn M, et al. Value Frameworks in Oncology: Comparative Analysis and Implications to the Pharmaceutical Industry. American health & drug benefits. 2017;10(5):253-60.
U.S. Preventive Services Task Force. U.S. Preventive Services Task Force Procedure Manual. Rockville, MD: U.S. Preventive Services Task Force; 2021.
World Health Organization. Health Technology Assessment – A Visual Summary. World Health Organization; 2021. https://www.who.int/data/stories/health-technology-assessment-a-visual-summary

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Non-specific or not otherwise classified codes may be subject to additional documentation requirements and review.

CPT/HCPCS

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

76497	Unlisted computed tomography procedure
76498	Unlisted magnetic resonance procedure
78499	Unlisted cardiovascular px dx nuclear medicine
81599	Unlisted multianalyte assay algorithmic analysis
84999	Unlisted chemistry procedure

ICD-10 Diagnosis

Refer to the ICD-10 CM manual

History

Status	Review Date	Effective Date	Action
Revised	01/24/2023	03/01/2023	Independent Multispecialty Physician Panel (IMPP) review. Address legal name change from AIM Specialty Health to Carelon Medical Benefits Management, Inc. Added language in the Description and Application of the Guidelines requiring use of FDA approved drugs, radiotracers, and devices in any intervention. Updated references.
Revised for Rehab	05/11/2020	12/01/2020	IMPP review. For use only with AIM Outpatient Rehabilitative and Habilitative Services guidelines, added to Clinical Appropriateness Framework: “Providers may be required to submit clinical documentation in support of a request for services…” and to Repeat Therapeutic Intervention: “For situations wherein ongoing services might be appropriate, requests for…”
Revised	05/11/2020	08/17/2020	IMPP review. Created separate document, added guideline scope, indications, and references. Added CPT codes 76497, 76498, 78499, 81599, 84999.
Revised	07/11/2018	03/09/2019	IMPP review. Renamed Administrative Guidelines to General Clinical Guideline for use across AIM solutions. Retitled Pretest Requirements to “Clinical Appropriateness Framework” to summarize the components of a decision to pursue diagnostic testing. To expand applicability beyond diagnostic imaging, retitled Ordering of Multiple Studies to “Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions” and replaced imaging-specific terms with “diagnostic or therapeutic intervention.” Repeated Imaging split into two subsections, “repeat diagnostic intervention” and “repeat therapeutic intervention.”
Revised	07/26/2016	10/31/2016	IMPP review. Revised to address pretest requirements for advanced imaging and ordering of multiple exams.
Created	03/30/2005	03/30/2005	Original effective date. Created Administrative Guidelines for application to AIM Diagnostic Imaging Utilization Management Guidelines.

Carelon Medical Benefits Management clinical appropriateness guidelines and cancer treatment pathways