Status: Created Effective Date: 12/30/2023
Doc ID: SUR01-1223.1 Last Review Date: 04/12/2023
Clinical Appropriateness Guidelines
“Site of Care,” “Site of Service” or another term such as “Setting” or “Place of Service” may be terms used in benefit plans, provider contracts, or other materials instead of or in addition to “Level of Care” and, in some plans, these terms may be used interchangeably.
© 2023 Carelon Medical Benefits Management, Inc. All rights reserved.
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.
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.
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.
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.
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
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.
“Site of Care,” “Site of Service” or another term such as “Setting” or “Place of Service” may be terms used in benefit plans, provider contracts, or other materials instead of or in addition to “Level of Care” and, in some plans, these terms may be used interchangeably.
Over the past several decades, services that were previously rendered solely in hospital settings have become available at non-hospital locations, such as freestanding facilities and physician offices. This shift in site of care, particularly for surgical and endoscopic procedures, has been fueled by the development of less invasive surgical approaches, improvement in anesthetic techniques, availability of portable equipment, and patient demand for the convenience of neighborhood services. The lower cost of non-hospital services and the economic advantage of global billing (from a provider perspective) have also contributed to the increased availability of non-hospital sites of care. Procedures rendered in non-hospital settings are reported to result in better patient outcomes compared to those performed in hospitals. However, there is a paucity of randomized data, and patient (and physician) selection may impact these outcomes.
This guideline applies to a limited list of outpatient procedures which are routinely performed at either a hospital outpatient department or in a non-hospital setting. The purpose of this guideline is to define the clinical scenarios in which hospital-based care is required and, by exclusion, when it is clinically reasonable to provide services in a non-hospital setting. This guideline does not address the clinical appropriateness of individual procedures but rather restricts its focus to the selection of optimal site of care where the service is rendered. Some procedures may also be subject to clinical appropriateness review; in which case, a separate clinical guideline will be used to adjudicate clinical appropriateness. The discussion applies to outpatients since site of care selection does not apply to those who are already hospitalized. The guideline does not address provider (or ancillary staff) qualification or credentialing to perform any procedure, nor does it attempt to define the adequacy of facilities or equipment used in rendering procedures. Although the accreditation and licensing of surgical facilities are not addressed in this document, it is assumed that facilities where services are rendered meet all required state and national requirements.
Nonhospital: Freestanding surgical facility or provider office that is not owned/operated by a hospital
Surgical procedure: For purposes of this guideline, this term encompasses procedures (see list) that can be safely rendered outside the hospital outpatient setting, including traditional surgical procedures (e.g., cataract extraction) and both diagnostic and therapeutic endoscopic procedures. The term excludes procedures that routinely require post-procedure admission to the hospital.
Acute coronary syndrome: Acute myocardial infarction (either ST elevation or non-ST elevation) or unstable angina pectoris
Asthma – moderate or severe: When any of the following are present, the patient can be considered to have moderate or severe asthma:
- Daytime symptoms every day
- Nocturnal symptoms at least once per week
- At least daily use of “rescue” inhaler to relieve symptoms
- FEV1 < 80% of predicted despite medical management
Chronic obstructive airways disease (COPD) – moderate or severe: Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of ≤ 0.7 and FEV1 < 80% of predicted
Diabetes – poorly controlled: Diabetes with hemoglobin A1c > 9 for more than one year, hospitalization for management of diabetic ketoacidosis within the past 6 months or requiring treatment for hypoglycemia within the past month
Hypetension – treatment resistant: Persistent hypertension in a patient taking three or more antihypertensive medications
Increased bleeding risk: Prior history of abnormal bleeding, established diagnosis of a condition which predisposes to bleeding (e.g., thrombocytopenia, hemophilia, prolonged INR despite treatment with vitamin K, need to continue anticoagulants or antiplatelet agents through to perioperative period), anticipated need for blood transfusion, blood products or other substances to control bleeding risk.
New York Heart Association (NYHA) Functional Classification: Symptom-based classification of the severity of heart failure as outlined below:
- Class I. Individuals with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; symptoms only occur on severe exertion.
- Class II. Individuals with cardiac disease resulting in slight limitation of physical activity; they are comfortable at rest; ordinary physical activity (e.g., moderate physical exertion, such as carrying shopping bags up several flights of stairs) results in fatigue, palpitation, dyspnea, or anginal pain.
- Class III. Individuals with cardiac disease resulting in marked limitation of physical activity; they are comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
- Class IV. Individuals with cardiac disease resulting in inability to carry on any physical activity without discomfort; symptoms of heart failure or the anginal syndrome may be present even at rest; if any physical activity is undertaken, discomfort is increased.
Obstructive sleep apnea (OSA) – moderate or severe: OSA diagnosed by either polysomnography or home sleep testing with Apnea Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) ≥ 15
Percutaneous coronary intervention: Coronary revascularization procedure (any combination of balloon angioplasty, coronary stent placement or coronary atherectomy) performed via a catheter inserted percutaneously. The term applies to intervention on either native coronary arteries or coronary bypass grafts.
Renal disease – end-stage: Patient is on regular dialysis or has glomerular filtration rate of < 15 mL/min per 1.73 m2
A hospital outpatient department (HOPD) is considered an appropriate location for services that meet medical necessity criteria (as applicable*) when ANY of the following conditions apply:
- Age ≤ 18 or ≥ 75 years
- Body mass index (BMI) ≥ 40
- Treatment resistant hypertension
- Poorly controlled diabetes
- End-stage renal disease
- Stroke or transient ischemic attack (TIA) within the prior 3 months
- Coronary artery disease with ANY of the following:
- Acute coronary syndrome within the prior 3 months
- Currently taking dual antiplatelet therapy which cannot be temporarily discontinued safely for the proposed surgical procedure
- Ongoing ischemic symptoms
- Established diagnosis of severe valvular heart disease
- Sustained, symptomatic cardiac arrhythmia despite treatment
- NYHA Class III or IV congestive heart failure
- Moderate or severe asthma
- Moderate or severe COPD
- Moderate or severe OSA
- Liver cirrhosis (with MELD score > 8)
- Duration of surgical procedure is expected to exceed 3 hours
- Increased bleeding risk
- Mental status change
- Intellectual disability or cognitive impairment
- Anticipated difficulty with establishment or maintenance of an airway based on preoperative airway assessment, prior history of difficult intubation, craniofacial abnormalities, limitation of neck extension, etc.
- Prior unanticipated surgical or anesthetic complication resulting in instability requiring unplanned admission or additional care beyond what is routinely rendered for that procedure (e.g., resuscitation, management of hemodynamic instability, prolonged observation, transfusion, etc.)
*Not all procedures that are subject to Site of Care review also require medical necessity review of the procedure itself
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. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.
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.
See link below for CPT code list.
Refer to the ICD-10 CM manual
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04/12/2023, 08/31/2021, 07/08/2020
Independent Multispecialty Physician Panel (IMPP) review. Added medical necessity language for clarification. Added reference. Added site of service terminology disclaimer. Original effective date.