Cigna Anesthesia Services for Interventional Pain Management Procedures in an Adult - (0551) Form

Coverage Policy

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients.

Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based.

For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits.

Medical directors are expected to exercise clinical judgment where appropriate and have discretion in making individual coverage determinations. Where coverage for care or services does not depend on specific circumstances, reimbursement will only be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s).

Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy (see “Coding Information” below). When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted Medical Coverage Policy:0551 for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines.

In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

This Coverage Policy addresses the administration of moderate sedation or anesthesia for interventional pain management procedures in an adult.

The policy does not apply to children under 18 years of age. Interventional pain management procedures include but are not limited to, diagnostic or therapeutic nerve blocks, diagnostic or therapeutic injections, and percutaneous image guided procedures.

For the intent of this medical coverage policy, interventional pain management procedures include the following:

• trigger point injections
• epidural steroid injection
• epidural blood patch
• facet joint injection
• peripheral and/or spinal nerve root block
• sacroiliac and other joint injection (e.g., knee, shoulder, hip)
• radiofrequency ablation
• implantation of spinal cord stimulator
• implantation of an intrathecal infusion device

The coverage criteria in this Medical Coverage Policy are based on recommendations from published practice parameters, recommendations, and professional society/organization consensus guidelines which support the use of moderate sedation and monitored anesthesia care for individuals undergoing outpatient interventional pain procedures who have certain risk factors or significant medical conditions that decrease safety during the procedure (e.g., severe anxiety).

For the intent of this coverage policy, severe anxiety is defined as being under active medical management (with psychotropic medication and/or cognitive therapy).

Coverage Policy MODERATE SEDATION

Moderate sedation for an adult (age 18 or over) undergoing an interventional pain management procedure is considered medically necessary when EITHER of the following criteria is met:

1. The interventional pain procedure requires the individual to remain motionless for a prolonged period of time or in a painful position (e.g., sympathetic blocks, plexus blocks, radiofrequency ablation procedures, implantation of spinal cord stimulator, implantation of an intrathecal infusion device)
2. Both of the following criteria are met:
   • Any of the following interventional pain procedures is being performed:
     • epidural steroid injection
     • epidural blood patch
     • peripheral and/or spinal nerve root block
     • sacroiliac joint injection
     • facet joint injection
   • Severe anxiety under active medical management with psychotropic medication and/or cognitive therapy, or other severe psychiatric condition(s), or severe cognitive impairment(s) that would risk putting the individual’s safety at risk during the planned procedure.

Moderate sedation for an adult (age 18 or over) undergoing an interventional pain management procedure is not covered or reimbursable for ANY other indication, including the following:

• Trigger point injection
• Peripheral joint injection (e.g., knee, shoulder, wrist)

MONITORED ANESTHESIA CARE

Monitored anesthesia care (MAC), including use of general anesthesia (i.e., intravenous anesthetic without a secured airway) for an adult (age 18 or over) undergoing an interventional pain management procedure is considered medically necessary when EITHER of the following criteria are met:

1. The interventional pain procedure requires the individual to remain motionless for a prolonged period of time or in a painful position (e.g., sympathetic blocks, plexus blocks, radiofrequency ablation procedures, implantation of spinal cord stimulator, implantation of an intrathecal infusion device)
2. Both of the following criteria are met:
   • One of the following interventional pain procedures is being performed:
     • epidural steroid injection
     • epidural blood patch
     • facet joint injection
     • peripheral and/or spinal nerve root block
     • sacroiliac joint injection
   • Presence of ANY of the following:
     • Increased risk for complications due to ASA physical status III or above
     • Any of the following comorbidities that increase risk for complications:
       • severe cardiac disease and/or pulmonary disease (e.g., severe hypotension [systolic < 90mm hg, major cardiac dysfunction)
       • documented sleep apnea
       • morbid obesity (body mass index [BMI] greater than or equal to 40 kg/m2)
       • chronic renal failure [GRF < 60ml/min for more than 3 months or stage 3A]
       • chronic liver disease [end stage liver disease score >10]
       • age > 70 years
     • Severe anxiety under active medical management with psychotropic medication and/or cognitive therapy, or other severe psychiatric condition(s), or severe cognitive impairment(s) that would risk putting the individual's safety at risk during the planned procedure.
     • Spasticity or movement disorder (e.g., cerebral palsy, dystonia, brain injury, stroke)
     • Individuals at risk of airway obstruction due to anatomical variation (e.g., neck mass, jaw abnormality, abnormality of oral cavity, neck tumor, neck edema, tracheal deviation)
     • Anticipated tolerance or physical dependence to sedatives/monitored sedation (e.g., chronic opioid or benzodiazepine use)
     • History of or active illicit drug or alcohol abuse

Note: The presence of a stable, treated condition, of itself, is not necessarily sufficient to support the need for MAC. The American Society of Anesthesiologists (ASA) physical status classification system for assessing a patient before surgery is defined as follows:

• P1 – A normal, healthy patient
• P2 – A patient with mild systemic disease
• P3 – A patient with severe systemic disease
• P4 – A patient with severe systemic disease that is a constant threat to life
• P5 – A moribund patient who is not expected to survive without the operation
• P6 – A declared brain-dead patient whose organs are being harvested

Monitored anesthesia care for an adult (age 18 or over) undergoing an interventional pain management procedure is not covered or reimbursable for ANY other indication, including ANY of the following:

• When no anesthetic is administered
• Trigger point injection
• Peripheral joint injection (e.g., knee, shoulder, wrist)

General Background

Interventional pain procedures are invasive interventions used to control acute or chronic pain conditions.

For the purposes of this policy, these include trigger point injections, epidural steroid injections, nerve blocks, other joint injections, radiofrequency ablation, and implantation of a spinal cord stimulator or implantation of an intrathecal infusion device. Anesthesia produces pain control, relief of anxiety, and muscle relaxation during surgical procedures.

Interventional pain procedures are frequently performed with local anesthesia and do not require supplemental sedation. When supplemental sedation is necessary, most often the physician performing the procedure administers minimal or moderate (i.e., conscious) sedation as part of the procedure; moderate sedation is not intended to impair the patient’s respiratory function or ability to maintain his or her airway. When using moderate sedation the physician has a dual role: performing the procedure and supervising the sedation.

Over-sedation may result in the inability of a patient to respond adequately to pain, discomfort, or paresthesia during a procedure and warn the physician accordingly of a potential impending serious complication (e.g., spinal cord injury) (Schneider, et al., 2018).

The American Society of Anesthesiologists (ASA) has defined the levels of sedation /analgesia as including minimal sedation, moderate sedation/analgesia (conscious sedation), deep sedation/analgesia and general anesthesia (ASA, 2014).

According to the ASA moderate sedation/analgesia (conscious sedation) is defined as a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Deep sedation/analgesia is defined by the ASA as a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

For most interventional procedures,

deep sedation and/or general anesthesia is considered as unsafe, since the patient cannot communicate acute injury-related pain and/or changes in symptoms (Kaye, et al., 2019). Although a majority of individuals require only local or moderate anesthesia, when undergoing interventional pain procedures a limited number of patients may require more extensive management of moderate or deep sedation by a second provider (ASA, 2018).

Monitored anesthesia care (MAC) is a service rendered by an anesthesia practitioner (i.e., anesthesiologist, certified registered nurse anesthetist CRNA]) who is not involved in the diagnostic or procedural service being performed. The ASA defines MAC as a specific anesthesia service for a diagnostic or therapeutic procedure which may include varying levels of sedation, analgesia, and anxiolysis as necessary.

While the anesthesia professional may administer sedation they are focused exclusively on airway, hemodynamic, and physiologic stability and must be prepared (and qualified) to convert to general anesthesia if necessary (ASA, 2018).

When monitored anesthesia care is provided, the anesthesia practitioner oversees many related services.

• Preprocedural assessment and management of patient comorbidity and periprocedural risk
• Diagnosis and treatment of clinical problems that occur during the procedure.

• Support of vital functions inclusive of hemodynamic stability, airway management and appropriate management of the procedure induced pathologic changes as they affect the patient’s coexisting morbidities.
• Administration of sedatives, analgesics, hypnotics, anesthetic agents or other medications as necessary for patient safety
• Psychological support and physical comfort
• Provision of other medical services as needed to complete the procedure safely.

Professional Societies/Organizations

Centers for Disease Control and Prevention (CDC): Recommendations for prescribing opioids for chronic pain have been published by the CDC (Dowell, Haegerich, Chou, 2016). Within these guidelines the CDC defines long term opioid therapy as “use of opioids daily or near daily for three months or greater.”

American Society of Anesthesiologists (ASA): The ASA has several documents available on their website regarding anesthesia recommendations. Please refer to the ASA references listed in the reference section of this Coverage Policy for further detail.

In a published statement on anesthetic care during interventional pain procedures for adults, the ASA states that interventional pain management procedures such as epidural steroid injections, epidural blood patch, trigger point injections, shoulder, hip, sacroiliac, facet and knee joint injections, medial branch nerve blocks, and peripheral nerve blocks do not require sedation (ASA, 2021).

However, for individuals with significant anxiety, when required to be motionless for prolonged periods of time, when required to remain in a painful position (e.g., nerve blocks, sympathetic blocks, radiofrequency ablation, spinal cord stimulator implantation, vertebral augmentation) or when less than 18 years of age moderate sedation may be necessary (ASA, 2021).

American Society of Interventional Pain Physicians (ASIPP): ASIPP published guidelines in 2019 for sedation and fasting status of patients undergoing interventional pain management procedures (ASIPP, 2019). Regarding levels of sedation, given that patients undergoing pain procedures typically are anxious and in pain, mild to moderate sedation is acceptable for many patients. Deeper sedation should only be undertaken in the presence of anesthesia providers and for patients who have high anxiety, complex pharmacotherapy, or a low pain threshold when undergoing more painful interventional pain procedures. In special cases, the risk of patient movement during a procedure resulting in potential inadvertent injury may justify a deeper anesthetic state.

U.S. Food and Drug Administration (FDA): Although pharmaceutical agents administered for analgesia and anesthesia are regulated by the FDA, monitored sedation and MAC is not.

The American Board of Internal Medicine’s (ABIM) Foundation Choosing Wisely® Initiative:

No relevant information found.

Use Outside of the US

European Society of Anaesthesiology and European Board of Anaesthesiology: In 2018, the European Society of Anaesthesiology and European Board of Anaesthesiology published guidelines for procedural sedation and analgesia in adults (Hinkelbein, et al., 2018). Evidence was evaluated using GRADE methodology and included assessment of 482 articles (systematic reviews, randomized controlled trials, cohort studies, and case control studies) in addition to existing guidelines.

Within this document the authors report that the following comorbidities require evaluation and management of procedural sedation and analgesia by an anesthesiologist:

• Severe cardiovascular disease
• Obstructive sleep apnea
• Morbid obesity (BMI > 40 kg/m²)
• Chronic liver disease (model for end-stage liver disease score ≥10)
• Age greater than 70 years
• American Society of Anesthesiologists physical status III to IV
• Abnormalities of/altered upper airway patency