MEDICAL POLICY

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APPENDIX
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Monitored Anesthesia Care (MAC)

Number 7.02.500

Effective Date April 14, 2014

Revision Date(s) 04/14/14; 05/13/13

Replaces 7.02.01

Policy

Use of monitored anesthesia care may be considered medically necessary for gastrointestinal endoscopy, bronchoscopy and interventional pain procedures, when there is documentation by the proceduralist or anesthesiologist that specific risk factors or significant medical conditions are present. Those risk factors or significant medical conditions that increase likelihood of complications or intolerance to moderate sedation anesthesia include any of the following:

  • Increased risk for complications due to severe comorbidity (ASA P3* or greater).
  • Morbid obesity (BMI >40).
  • Severe sleep apnea (oxygen or bi-pap required during sleep).
  • Inability to follow simple commands (cognitive dysfunction, intoxication, or psychological impairment).
  • Spasticity or movement disorder complicating procedure.
  • History or anticipated intolerance to standard sedatives, such as:
  • Patients with active medical problems related to drug or alcohol abuse.
  • Patients younger than 18 years or 70 years and older
  • Patients who are pregnant.
  • Patients with increased risk for airway obstruction due to anatomic variation, such as:
  • Dysmorphic facial features,
  • Oral abnormalities (e.g., macroglossia),
  • Neck abnormalities (e.g., neck mass), and
  • Jaw abnormalities (e.g., micrognathia).
  • Acutely agitated, uncooperative patients (e.g., delirium, organic brain disease, senile dementia)
  • Prolonged or therapeutic gastrointestinal endoscopy procedures requiring deep sedation. (See Policy Guidelines)

[*American Society of Anesthesiologists (ASA) physical status classification system for assessing a patient before surgery:

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 ]

Use of monitored anesthesia care is considered not medically necessary for gastrointestinal endoscopic, bronchoscopic, or interventional pain procedures in patients at average risk related to use of anesthesia and moderate sedation.

Related Policies

8.01.40

Manipulation Under Anesthesia

11.01.504

Adult Upper Gastrointestinal Endoscopy

Policy Guidelines

History of or anticipated intolerance to standard sedatives

The patient must be unable to tolerate standard sedatives (or it is anticipated that he/she will not be able to) due to chronic daily use of narcotic pain medication (opioids) or chronic daily use of prescription sedatives (benzodiazepines such as Valium®, Xanax®, Halcion®, Ativan®, Klonopin®) whose dosages and/or frequency would be expected to affect sedation requirements.

Standard use of psychiatric medications such as antidepressants or sleep aids does not confer high risk.

Prolonged Endoscopic Procedures

Examples of prolonged endoscopy procedures that may require deep sedation include adhesions post-abdominal surgery, endoscopic retrograde cholangiopancreatography, stent placement in the upper GI tract, and complex therapeutic procedures such as plication of the cardioesophageal junction. Prolonged procedures are generally greater than 60 minutes.

Monitored anesthesia care may also be considered medically necessary during the procedure to dilate an esophageal stricture.

Mallampati Score

The Mallampati score is considered a predictor of difficult tracheal intubation and is routinely used in preoperative anesthesia evaluation. (5) The score is obtained by having the patient extend the neck, open the mouth, and extend the tongue while in a seated position.

Patients with Class 3 or 4 Mallampati scores are considered to be at higher risk of intubation difficulty. While the Mallampati score does not by itself determine a need for monitored anesthesia care, it may be considered in determining risk for airway obstruction. Other tests to predict difficult tracheal intubation include the upper lip bite test, the intubation difficulty scale, and the Cormack-Lehane grading system.

Patients are scored from Class 1-4 as follows:

Class 1 the tonsils, uvula and soft palate are fully visible

Class 2 the hard and soft palate, uvula and upper portion of the tonsils are visible

Class 3 the hard and soft palate and the uvula base are visible

Class 4 only the hard palate is visible.

Description

Adequate sedation and analgesia are important parts of many diagnostic and therapeutic procedures. Various levels of sedation and analgesia (anesthesia) may be used, depending on the patient’s condition and the procedure being performed. This policy addresses the potential role of dedicated anesthesia providers during procedures performed in a properly-equipped and staffed outpatient setting.

Background

Monitored anesthesia care (MAC) refers to a service provided by anesthesia personnel who are present during a procedure, and does not implicitly indicate the level of anesthesia needed. The American Society of Anesthesiologists (ASA) has defined monitored anesthesia care (MAC). (1) The following is derived from ASA statements:

“Monitored anesthesia care is a specific anesthesia service for a diagnostic or therapeutic procedure. Indications for monitored anesthesia care include the nature of the procedure, the patient’s clinical condition and/or the potential need to convert to a general or regional anesthetic.”

MAC includes all aspects of anesthesia care – a preprocedure visit, intraprocedure care and postprocedure anesthesia management. During monitored anesthesia care, the anesthesiologist provides or medically directs a number of specific services, including but not limited to:

  • Diagnosis and treatment of clinical problems that occur during the procedure;
  • Support of vital functions;
  • Administration of sedatives, analgesics, hypnotics, anesthetic agents or other medications as necessary for patient safety;
  • Psychological support and physical comfort; and
  • Provision of other medical services as needed to complete the procedure safely.

MAC may include varying levels of sedation, analgesia, and anxiolysis as necessary. The provider of MAC care must be prepared and qualified to convert to general anesthesia when necessary. If the patient loses consciousness and the ability to respond purposefully, the anesthesia care is a general anesthetic, irrespective of whether airway instrumentation is required.

In 2004, the ASA defined four levels of sedation/ analgesia as follows: (2)

  • Minimal sedation (Anxiolysis): is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilator and cardiovascular function are unaffected.
  • Moderate sedation/analgesia (“conscious” sedation): is 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 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.
  • General anesthesia: is a drug-induced depression of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilator function is often impaired. Patients often require assistance in maintaining a patent airway, and positive-pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Individuals administering moderate sedation/analgesia (conscious sedation) should be able to rescue patients who enter a state of deep sedation/analgesia, while those administering deep sedation/analgesia should be able to rescue patients who enter a state of general anesthesia.

According to the American Society of Anesthesiologists’ (ASA) standard for monitoring, MAC should be provided by qualified anesthesia personnel, including physicians and nurse specialists. (3) By this standard, the personnel must be in addition to the proceduralist, and present continuously to monitor the patient and provide anesthesia care. MAC may be used for varying levels of sedation, analgesia, and anxiolysis, including but not limited to moderate sedation. For patients at high risk of an unsuccessful procedure under moderate sedation, this allows for the safe continuation of the procedure under deep sedation or general anesthesia by trained personnel.

Moderate sedation can be achieved using pharmacologic agents for sedation, anxiolysis and analgesia. A frequently used combination is an opioid and benzodiazepine, for example fentanyl with midazolam, at doses individualized to obtain the desired sedative effect. Other combinations have also been utilized for this purpose. While both benzodiazepines and opioids can cause respiratory depression, effective reversal agents exist for both.

Propofol is an agent that has been used increasingly to provide sedation for procedures. Propofol is associated with a rapid onset of action and fast recovery from sedation. However, there have been concerns about potential side effects and safety when used by non-anesthesiologists. Propofol has the potential to induce general anesthesia, and there is no pharmacologic antagonist to reverse its action. ASA has offered practice guidelines for the provision of sedation by non-anesthesiologists, stating that personnel must be prepared to respond to deep sedation and loss of airway protection should these complications inadvertently occur during sedation. (4)

This policy only addresses anesthesia services for diagnostic or therapeutic procedures involving gastrointestinal (GI) endoscopy, bronchoscopy and interventional pain procedures performed in the outpatient setting.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

N/A

Rationale

Literature Review

This policy was created in 2009 and updated regularly with searches of the MEDLINE database. The most recent literature search was through January 2013. One updated systematic review on the use of propofol for sedation during colonoscopy has been published by the Cochrane Collaboration. One randomized controlled trial (RCT) has examined the use of moderate sedation with monitored anesthesia care (MAC) against moderate sedation without monitored care; it has been published in abstract form only. Many of the RCTs and comparative studies have focused on comparisons of agents for moderate sedation. Many recommendations for the indications for monitored anesthesia care come from narrative reviews and expert opinion. The following is a summary of the key literature to date:

Location of the Procedure

The American Society of Anesthesiologists (ASA) has recommended that any location providing MAC have the capability of cardiopulmonary resuscitation and monitoring equipment. (6, 7) In 2004, Fleisher and colleagues performed a retrospective claims data review on 564,267 outpatient surgical procedures: 360,780 at an outpatient department of a hospital, 175,288 at an ambulatory surgical center and 28,199 at a physician’s office. (8) The rates of all-cause death, emergency department visits and inpatient admissions within 7 days of the procedure were compared. The highest rates were seen among patients in the outpatient surgery department of the hospital, suggesting that patients evaluated to be at highest risk had their procedure in the location of lowest anesthesia risk. Multivariate analysis noted that increasing patient age, increasing procedural risk, and increasing past medical history of inpatient admissions were all independently predictive of adverse outcome.

Use of Monitored Anesthesia Care in Endoscopy

An extensive review of the literature related to sedation for gastrointestinal (GI) endoscopy was published through the American Gastroenterological Association (AGA) Institute in 2007. (9) Portions of their review were relevant to this policy. The review recommended that use of an anesthesia professional should be strongly considered for American Society of Anesthesiologists (ASA) physical status III through V patients. They noted that other possible indications for participation by an anesthesia specialist include patients with pregnancy, morbid obesity, neurologic or neuromuscular disorders, a history of alcohol or substance abuse, and patients who are uncooperative or delirious. They also noted that endoscopic procedures that may require an anesthesia specialist include endoscopic retrograde cholangiopancreatography (ERCP), stent placement in the upper GI tract, and complex therapeutic procedures such as plication of the cardio-esophageal junction. This review was used in formulating the conclusions of this policy.

Comparison of Sedative Agents Used in Endoscopy

Given the interest in use of propofol, additional details are provided concerning its use in GI endoscopy. A recent Cochrane review by Singh et al. in 2008 summarized the results of 20 RCTs comparing the use of propofol and traditional agents for use during colonoscopy. (10) This review encompassed and enlarged on a prior review by McQuaid and Laine in 2008, which reviewed a broader set of studies of all randomized trials of any agents used for sedation for endoscopic procedures. (11) The reviews come to largely similar conclusions, but certain comparisons were only performed in one or the other review.

The primary objective of the Cochrane review was to compare the relative effectiveness, patient acceptance, and safety of propofol compared to traditional sedatives for patients undergoing colonoscopy. (10) The secondary objective was to synthesize the studies comparing propofol administration by anesthesiologists to that by non-anesthesiologists for sedation during colonoscopy. This review is an update of a previously published Cochrane systematic review in 2008.The literature search for the updated review was undertaken up to December 2010. The outcome measures of interest were technical performance of colonoscopy (recovery time, discharge time, procedure time), patient satisfaction, pain control, and complication rates (cardio-respiratory events, colonic perforations and hospital admission rate after procedure, and death). (10)

Twenty-two studies met the inclusion criteria for the primary objective in this updated review. (10) Eight (of 22) eligible RCTs evaluated propofol as a single agent, and 7 trials were published in only abstract format, including the largest trial from 2000 (n=7,286 patients), which reported on different rates of colonic perforation. Only one trial published in 2006 was a double-blinded RCT, where all patients as well as all those involved in administering the medications and assessing the outcomes were not aware of the intervention in different arms of the trial. The agents administered in the control arms across these trials included benzodiazepines alone (diazepam, midazolam) or a combination of a benzodiazepine and a narcotic (pethidine, fentanyl, remifentanil or alfentanil). One trial published in 2003 included only a narcotic (remifentanil), and all patients in the control arm of this study remained awake throughout the procedure. The dosage of the agents used varied across trials. The intended level of sedation when stated was defined in most studies as that needed for patients tolerance of the procedure. Many of the studies had a potential of moderate to high risk of bias and combining data for some of the outcomes for meta-analysis was problematic. Most studies included only healthy outpatients.

Recovery time (reported in 11 studies; 776 patients) was shorter with propofol compared to the control arm (weighted mean difference [WMD]: -14.2 minutes; 95% confidence interval [CI]: -17.6, -10.8), with no significant heterogeneity (p=0.41). Discharge time (7 studies; 542 patients) was also reported to be shorter with use of propofol (WMD: -20.9 minutes; 95% CI: -30.9, 10.8); however, there was significant heterogeneity between studies (p<0.0001). There was higher patient satisfaction (10 studies, 819 patients) with use of propofol (odds ratio [OR]: for dissatisfaction 0.35; 95% CI: 0.23, 0.53). There was no difference in procedure time (9 studies; 736 patients) or complication rates. There was also no difference in pain control with non-patient controlled sedation (5 studies; 396 patients) between propofol and the control arm (OR: 0.90; 95% CI: 0.58, 1.39). (10)

The Cochrane review found only one RCT, reported in abstract format, for the secondary objective, comparison of propofol administration by anesthesiologists (Group A) to that by endoscopists (Group B). (12) This RCT has subsequently been published by Poincloux and colleagues. (12) Ninety adult patients (from a university center in France) undergoing colonoscopy were randomized into the above 2 groups. The goal of propofol administration by anesthesiologists was anesthesia and that by endoscopists was sedation. There was no difference in procedure time (16.7 minutes for Group A and 17.7 minutes for Group B) or patient satisfaction (average score on Visual Analog Scale, 90.8 vs. 89). A higher proportion of patients administered propofol by an anesthesiologist experienced hypoxia, but no patient required an intervention. (12)

There are numerous observational studies, and some of the representative publications are summarized here. Horiuchi et al. reported an observational study from Japan. (13) Low-dose propofol was administered by nurses supervised by the endoscopist during diagnostic endoscopy. In this study, 10,662 patients were observed following the receipt of an age-dependent standard dose protocol of propofol, which was administered by bolus injection, with additional doses given when required for adequate sedation prior to esophagogastroduodenoscopy (EGD). The incidence of respiratory depression was the primary outcome for this study, and further measures of successful completion of the procedure and patient satisfaction were analyzed. Twenty-eight patients required transient supplemental oxygen supply, while none required mask or endotrachael intubation. All procedures were successful and 79.1% diagnostic EGDs were completed with a single bolus of propofol. The authors conclude that low-dose nurse-administered propofol sedation is safe when supervised by the endoscopist, and practical for diagnostic EGD. The study is limited by the lack of a comparison group. Patients with ASA classification III and IV were excluded from the study, so these conclusions may not be generalized to that group.

Coté et al. reported another prospective observational study on 766 patients undergoing advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound and small-bowel enteroscopy who received propofol. (14) These procedures are notable for the duration and complexity of these procedures compared to diagnostic EGD. The primary outcome measure was airway modifications (AMs) with a comparison of defining characteristics of the group requiring at least one airway modification, such as chin lift or nasal airway, to those requiring no modification. No patients in the study required endotrachael intubation. Body mass index (BMI), male sex, and ASA class III or above were associated with a need for AM. Patients in this study received anesthesia from a certified registered nurse anesthetist (CRNA) and generally had a level of deep sedation, and thus continue to meet the definition of MAC.

Rex et al. reviewed case series of endoscopist-directed propofol sedation published in MEDLINE, CINAHL and EMBASE over the period of 1966 to 2008, resulting in 646,080 procedures in 28 studies published between 2002 and 2008. (15) Incidence of mask ventilations, endotrachael intubation, neurologic injuries and death were collected from the published studies and calculated to reveal a death rate 0.62 per 100,000 cases. A direct comparison group was not included in this review. The authors state this death rate compares favorably to published surveys of death rates of endoscopic procedures utilizing opioids and benzodiazepines of 11 per 100,000. They also compare this to published data on the general anesthesia overall death rate of 1-2 per 100,000. As mentioned, a direct comparison group is not available nor is death rates available for endoscopic procedures under MAC. However, the incidence of published adverse events appears to be low.

Agostoni and colleagues evaluated a prospective database of 17,999 GI endoscopies performed under MAC during the period of October 2001 to December 2009. (16) The authors identified 6 variables predicting any sedation-related complication using multivariate logistic regression models: age (1-year OR: 1.02 [95% confidence interval [CI]: 0.01-1.02]), BMI (1-point OR: 1.03 [95% CI: 0.02-1.05]), ASA score (“3-4” vs. “1-2” OR: 1.69 [95% CI: 1.44-1.99]), Mallampati score (“3-4” vs. “1-2” OR: 1.33 [95% CI: 1.04-1.70]), emergency nature of the procedure (OR: 1.48 [95% CI: 1.13-1.94]), length of the procedure (OR: 2.00 [95% CI: 1.78-2.24]). The authors noted the Mallampati score is used to assess potential difficulty in tracheal intubation, and it is unclear why this score was predictive of any complication.

In a prospective cohort study of 470 ERCP patients receiving MAC, Berzin and colleagues reported adverse respiratory events were strongly associated with higher body mass index using multivariate regression models. (OR: 1.08; p=0.0006). (17) Patients with obesity experienced respiratory events almost twice as often as non-obese patients (p=0.03). Higher ASA class was not associated with adverse respiratory events under MAC (OR: 1.2; p=0.25) but was associated with cardiovascular events (OR: 2.88; p<0.0001).

Conclusions

The evidence base comparing different anesthetic methods is not robust, consisting primarily of non-randomized comparisons and observational studies. A single RCT comparing propofol administration by anesthesiologists to that by non-anesthesiologists for sedation during colonoscopy did not show any differences in procedure time or patient satisfaction, and reported a higher rate of hypoxia in patients treated with propofol. However, a Cochrane review of randomized studies concluded that recovery time, discharge time, and patient satisfaction were all improved with propofol compared to alternative agents. This review did not find any evidence of increased complications. However, this evidence base does not rule out an increased complication rate with propofol, since there is a low complication rate in general, thus making it difficult to discern differences in the absence of large RCTs.

Bronchoscopy

In 2009, Silvestri and colleagues published an RCT comparing two doses of the sedative agent fospropofol in patients undergoing diagnostic bronchoscopy. (18) The study was performed by pulmonologists without anesthesia supervision. Patients (n=252) were randomized to receive either 2 mg/kg or 6.5 mg/kg induction doses of fospropofol, followed by additional doses per protocol. All patients received a pre-procedural dose of fentanyl. The primary endpoint was sedation success using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S). A secondary endpoint was treatment success, as measured by percentage of patients who did not require alternate sedation or ventilation. The higher dose group had greater sedation success (88.7% vs. 27.5%, respectively; p < 0.001). Treatment success also favored the higher dose group (91.3% vs. 41.25, respectively; p < 0.001). Adverse events were higher for the higher dose group; for example, the number of patients requiring any type of airway assistance (33 vs. 14, or 21.5% vs. 13.6%, respectively). The trial does not compare alternate sedation approaches; that comparison is necessary to evaluate the clinical value of the fospropofol sedation strategy for bronchoscopic procedures.

The British Thoracic Society published guidelines for flexible bronchoscopy in 2001. (19) With respect to sedation, the guidelines state that sedation should be offered, patients should be monitored during and immediately after the procedure, and that at least two assistants, at least one a qualified nurse, should be in attendance. Resuscitation equipment should be readily available. The sedation agents are not specified.

Interventional Pain Management Procedures

In 2008, Bernards and colleagues published a review of the literature around neurologic complications of regional anesthesia in anesthetized or heavily sedated patients. (21) Some experts postulate that the inability of a sedated patient to express atypical symptoms during a regional block may lead to increased risk of injury. No comparative studies have been done, and limited information is available from registries. The American Society of Regional Anesthesia and Pain Medicine has acknowledged the scarce and conflicting literature on the topic, and recommends carefully weighing the risks and benefits in considering performing those procedures while the patient is heavily sedated or anesthetized. (22)

In 2005, the American Society of Anesthesiologist released a statement on anesthetic care during interventional pain procedures. (23) While recognizing that conditions exist which may make skilled anesthesia care necessary, most minor pain procedures, under most routine circumstances, do not require anesthesia care other than local anesthesia.

Other Procedures

Any procedure which may be complicated by patient characteristics noted in the policy statement may be appropriate for MAC.

Pregnancy

Concerns regarding procedures and sedation during pregnancy are two-fold: sensitivity of the fetus to the agents and/or procedural hypotension, and maternal factors that increase sensitivity to sedation and that make intubation more difficult in an emergency situation. In a large (n=720,000) Swedish registry of pregnant patients from the 1970’s and 1980’s, 5405 operations took place. (24) Congenital malformations and stillbirths were not increased in the offspring of women having an operation. Incidence of low birth weight infants was increased as a result of both prematurity and intrauterine growth retardation. Neonatal death was also increased in the patients who had an operation. No specific types of anesthesia or operation were associated with these outcomes. The contribution of the underlying condition which led to the need for surgery could not be separated from the effects of the surgery or sedation/anesthesia.

Fetal heart rate monitoring is considered to be a more sensitive indicator of placental perfusion and fetal oxygenation than observations of maternal hemodynamic stability alone. The American College of Obstetricians and Gynecologists (ACOG) has recommended that the use of intermittent or continuous fetal monitoring during surgery be individualized. (25)

Physiologic changes in pregnancy may require changes in standard doses of anesthetic or sedative agents. However, propofol does not generally require a change in loading dose for induction. (26) Physiologic changes in pregnancy may warrant MAC when airway protection may become necessary, due to additional difficulties noted with emergent intubation in pregnant patients and the urgency to restore full oxygenation to the maternal and fetal patients. (27) Thus MAC can be considered medically necessary for procedures performed during pregnancy.

Ongoing Clinical Trials

A search of online site Clinicaltrials.gov did not identify any open studies evaluating predictive factors for risks of sedation-related adverse events.

Practice Guidelines and Position Statements

In 2004, and amended in 2009, the American Society of Anesthesiologists released a statement on the safe use of propofol:

“The Society believes that the involvement of an anesthesiologist in the care of every patient undergoing anesthesia is optimal. However, when this is not possible, non-anesthesia personnel who administer propofol should be qualified to rescue patients whose level of sedation becomes deeper than initially intended and who enter, if briefly, a state of general anesthesia.” (28)

Recent guidelines regarding sedation during endoscopy were released by the American Society for Gastrointestinal Endoscopy (ASGE). (29) These guidelines indicate “Adequate and safe sedation can be achieved in most patients undergoing routine esophagogastroduodenoscopy [EGD] and colonoscopy by using an intravenous benzodiazepine and opioid combination.” These guidelines also include a discussion of use of propofol for routine endoscopy, and their overall conclusion is that “clinically important benefits in average-risk patients undergoing upper endoscopy and colonoscopy have not been consistently demonstrated with regard to patient satisfaction and safety. Therefore, the routine use of propofol in average-risk patients cannot be endorsed.” In addition to addressing the efficacy and safety of propofol, the guidelines discuss the issue of who is qualified to give propofol. The ASGE endorses gastroenterologist-directed propofol use when adequate training for its use has been achieved. Numerous case series studies were cited showing very low rates of clinical adverse events when propofol was administered by registered nurses under gastroenterologist supervision.

The American Society for Gastrointestinal Endoscopy guideline titled Modifications in Endoscopic Practice for Pediatric Patients recommends the use of general anesthesia or MAC for pediatric endoscopy, usually based upon age or anticipated patient intolerance for the procedure. In pediatric patients, there is an increased risk of adverse events and the pediatric patient is often psychologically traumatized by this invasive procedure. Therefore, the policy statement is amended to include all patients age 18 and younger.

Wang and colleagues performed a retrospective cohort analysis of the number of polyps found on colonoscopy when using moderate conscious sedation or deep sedation. (30) The study has several flaws that limit its reliability. First, according to Table 1 in the study, there were differences in the rates of administration of deep sedation versus moderate conscious sedation according to race, gender, age, practice setting, and ASA classification. It is noted that a higher percentage of patients receiving deep sedation were ASA classification level 3 (9.4% vs 3.5% in the moderate sedation group). Interpretation of results when baseline characteristics of the populations being compared differ on so many important factors is generally regarded as unreliable in the scientific community. As such, the comparison of these two populations is unreliable and no meaningful conclusions can be drawn. Secondly, the study design is a retrospective cohort study. There was no control for the criteria that were used to determine whether or not patients received moderate conscious sedation or deep sedation. As such, it is impossible to extrapolate any conclusions or recommendations about when moderate conscious sedation or deep sedation is appropriate. Lastly, the authors actually report higher rates of polyp detection with moderate conscious sedation and more advanced lesions were found with deep sedation. However, because the study design does not have a way to establish the true rate of polyps, it is impossible to determine if the results demonstrate a difference in the actual rate of detection of polyps that existed at the time of the procedure. The study uses the number of patients receiving colonoscopy as a determinant of the rate of polyp detection rather than the number of actual polyps. There could be selection bias involved in the choice of patients undergoing deep sedation rather than moderate conscious sedation that skews the actual prevalence rate of advanced lesions in that population. This would be expected if endoscopists applied the AGA guidelines noted above. Therefore, the true rate of detection of polyps or advanced lesions is unknown. The authors acknowledge the limitations of this study, concluding: “… this retrospective design has limitations that necessitate follow-up with prospective studies. These follow-up studies would be essential to support any change in the standard practices of sedation.”

In a randomized controlled trial, Paspatis and colleagues reported on 520 individuals undergoing colonoscopy for the detection of polyps. (31)They were randomized to either deep sedation (n=258) or moderate sedation (n=262) with the hypothesis that deep sedation may increase the rate of polyp detection compared to moderate sedation which would enhance the quality of the colonoscopy. Secondary objectives included the patient’s and the endoscopist’s satisfaction, recovery time and the adverse events related to sedation between the two groups. There were no differences between the two groups in the following three areas: (1) The overall detection of polyps, (2) polyp size ≥ 10 mm, and (3) polyp size < 10 mm. There was no significant difference in the rate of adenoma detection. There were no differences in levels of participant satisfaction between the two groups. However, the endoscopist's satisfaction rating was greater in the deep sedation group compared to the moderate sedation group. The authors concluded that the study demonstrated no difference in the detection of polyps by colonoscopy using deep or moderate sedation.

Following the Paspatis study, Metwally and colleagues performed a retrospective study to determine if anesthesiologist-monitored use of propofol results in improved detection of adenomas when compared with routine conscious sedation. (32) This study was conducted at two separate hospital-based endoscopy units where approximately 12,000 endoscopic procedures are performed annually, with one endoscopy unit exclusively using anesthesiologist-monitored propofol. Three thousand two hundred and fifty-two patients underwent initial screening or surveillance colonoscopies. The primary end point was the adenoma detection rate, defined as the number of patients in whom at least one adenoma was found, associated with the type of sedation. Three thousand two hundred and fifty-two outpatient colonoscopies were performed by five selected endoscopists. At least one adenoma was detected in 27.6% of patients with no difference in the detection rate between the anesthesiologist-propofol group and the gastroenterologist-midazolam/fentanyl group. As with the Paspatis study, they concluded that the type of sedation used during colonoscopy does not affect the number of patients in whom adenomatous polyps are detected.

Liu and colleagues noted that the use of an anesthesiologist or nurse anesthetist for low-risk colonoscopies and upper gastroenterology procedures is rapidly increasing, with recent data suggesting a 24% rate in 2007 and a projected increase to 53% by 2015. (33) They stated: “It is unknown at this point what drives the increase in anesthesia use during endoscopies and to what degree the increase reflects potentially discretionary spending, which may present an opportunity to reduce cost”. The authors performed a retrospective analysis of claims data to determine the frequency with which anesthesiologists or nurse anesthetists provide sedation for gastrointestinal endoscopies, especially for low-risk patients, and the regional variation. They sampled 1.1 million adults in the Medicare population 5.5 million commercially insured patients between 2003 and 2009. Their main outcome measure was the total number of upper gastrointestinal endoscopies and colonoscopies, proportion of gastroenterology procedures with associated anesthesia claims, payments for gastroenterology anesthesia services, and proportion of services and spending for gastroenterology anesthesia delivered to low-risk patients (American Society of Anesthesiologists physical status class 1 or 2). They found that the number of gastroenterology procedures per million enrollees remained largely unchanged in Medicare patients, but increased more than 50% in commercially insured patients from 2003 to 2009. In both populations, the proportion of procedures using anesthesia services increased from approximately 14% in 2003 to more than 30% in 2009, and more than two-thirds of anesthesia services were delivered to low-risk patients. In addition, there was substantial regional variation in the proportion of low-risk procedures using anesthesia services in both populations, ranging from 13% in the West to 59% in the Northeast. Payments for gastroenterology anesthesia services doubled in Medicare patients and quadrupled in commercially insured patients. The authors state that the substantial regional variation in gastroenterology anesthesia use for low-risk patients suggests that a significant share of the spending for gastroenterology anesthesia may be considered potentially discretionary. Supporting the hypothesis of potentially discretionary use is the 4-fold difference in use between the lowest-use and the highest-use regions. They felt that this variation is unlikely to be fully explained by regional difference in patient risk.

Summary

Monitored anesthesia care (MAC) is the use of anesthesia personnel during a procedure to provide various levels of sedation and analgesia (anesthesia) depending on the patient’s condition and the procedure being performed. This policy addresses the potential role of dedicated anesthesia providers during diagnostic or therapeutic procedures involving gastrointestinal endoscopy, bronchoscopy, and interventional pain procedures performed in the outpatient setting.

Comparative evidence supporting the use of monitored anesthesia care in specific procedures is limited. Patient characteristics, such as comorbidities, airway features or the ability to cooperate with the proceduralist, are more indicative of the need for this service. Physician-directed moderate sedation is a safe and effective alternative to MAC for the majority of patients undergoing procedures for which deep sedation or anesthesia is unnecessary, such as gastrointestinal endoscopy, bronchoscopy, and interventional pain procedures. Propofol may be used both for general anesthesia and moderate sedation. The principal differences between propofol and the traditional agents used in these clinical trials of moderate sedation are a shorter recovery period (a mean of 14.2 minutes), shorter discharge time, and higher overall satisfaction scores. Pain control and incidence of complication rates appear to be similar overall, but the available evidence does not rule out small differences in these outcomes. The use of MAC may be considered medically necessary in specific cases of high risk of potential complications related to moderate sedation as outlined in the policy statement.

References

  1. American Society of Anesthesiologists (ASA). ASA position on monitored anesthesia care. Amended September 2, 2008. Last accessed April 2, 2014.
  2. American Society of Anesthesiologists (ASA). Levels of sedation/analgesia. Amended October 29, 2009. Last accessed April 2, 2014.
  3. American Society of Anesthesiologists (ASA). Distinguishing monitored Anesthesia care ("MAC") from moderate sedation/analgesia. Amended October 21, 2009. Last accessed April 2, 2014.
  4. American Society of Anesthesiologists (ASA). Statement on qualifications of anesthesia provides in the office-based setting. Amended October 21, 2009. Last accessed April 2, 2014.
  5. Mallampati SR, Gatt SP, Gugino LD et al. A clinical sign to predict difficult tracheal intubation: a prospective study. Canadian Anaesthetists Society Journal 1985; 32(4):429-34.
  6. American Society of Anesthesiologists. Statement on nonoperating room anesthetizing locations. Amended October 2008. Last accessed April 2, 2014.
  7. American Society of Anesthesiologists. Guidelines for ambulatory anesthesia and surgery. Amended October 2008. Last accessed April 2, 2014.
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  10. Singh H, Poluha W, Cheung M et al. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev 2008; (4):CD006268.
  11. McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc 2008; 67(6):910-23.
  12. Poincloux L, Laquiere A, Bazin JE et al. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liv Dis 2011; 43(7):553-8.
  13. Horiuchi A, Nakayama Y, Hidaka N et al. Low-dose propofol sedation for diagnostic esophagogastroduodenoscopy: results in 10,662 adults. Am J Gastroenterol 2009; 104(7):1650-5.
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  16. Agostoni M, Fanti L, Gemma M et al. Adverse events during monitored anesthesia care for GI endoscopy: an 8-year experience. Gastrointestinal Endoscopy 2011; 74(2):266-75.
  17. Berzin TM, Sanaka S, Barnett SR et al. A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administered sedation. Gastrointestinal Endoscopy 2011; 73(4):710-7.
  18. Silvestri GA, Vincent BD, Wahidi MM et al. A phase 3, randomized, double-blind study to assess the efficacy and safety of fospropofol disodium injection for moderate sedation in patients undergoing flexible bronchoscopy. Chest 2009; 135(1):41-7.
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  20. British Thoracic Society Guidelines. Available online at: http://www.brit-thoracic.org.uk/guidelines.aspx. Last accessed April 2, 2014.
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  23. American Society of Anesthesiology (ASA). Statement on anesthetic care during interventional pain procedures for adults. Amended October 22, 2005. Last accessed April 2, 2014.
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Coding

Codes

Number

Description

CPT

00520

Anesthesia for closed chest procedures; (including bronchoscopy) not otherwise specified

 

00635

Anesthesia for procedures in lumbar region; diagnostic or therapeutic lumbar puncture

 

00740

Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum

 

00810

Anesthesia for lower intestinal endoscopic

 

01936

Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic

 

01991

Anesthesia for diagnostic or therapeutic nerve blocks and injections (when block or injection is performed by a different provider); other than prone position

 

96373

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intra-arterial

 

96374

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance or drug

 

99143

Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status; younger than 5 years of age, first 30 minutes intra-service time

 

99144

Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status; age 5 years or older, first 30 minutes intra-service time

 

99145

Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient's level of consciousness and physiological status; each additional 15 minutes intra-service time (List separately in addition to code for primary service)

 

99148

Moderate sedation services (other than those services described by codes 00100-01999), provided by a physician other than the health care professional performing the diagnostic or therapeutic service that the sedation supports; younger than 5 years of age, first 30 minutes intra-service time

 

99149

Moderate sedation services (other than those services described by codes 00100-01999), provided by a physician other than the health care professional performing the diagnostic or therapeutic service that the sedation supports; age 5 years or older, first 30 minutes intra-service time

 

99150

Moderate sedation services (other than those services described by codes 00100-01999), provided by a physician other than the health care professional performing the diagnostic or therapeutic service that the sedation supports; each additional 15 minutes intra-service time (List separately in addition to code for primary service)

ICD-9-CM Diagnosis

152.0

Malignant neoplasm of small intestine, duodenum

 

152.1

Jejunum

 

152.2

Ileum

 

152.3

Meckel's diverticulum

 

152.8

Other specified sites of small intestine

 

152.9

Small intestine, unspecified

 

153.0

Malignant neoplasm of colon, Hepatic flexure

 

153.1

Transverse colon

 

153.2

Descending colon

 

153.3

Sigmoid colon

 

153.4

Cecum

 

153.5

Appendix

 

153.6

Ascending colon

 

153.7

Splenic flexure

 

153.8

Other specified sites of large intestine

 

153.9

Colon, unspecified

 

154.0 – 154.8

Malignant neoplasm of rectum, rectosigmoid junction and anus, code range

 

155.1

Malignant neoplasm of intrahepatic bile ducts

 

156.1-156.9

Malignant neoplasm of gallbladder and extrahepatic bile ducts, code range

 

157.0

Malignant neoplasm of pancreas; head of pancreas

 

157.1

Body of pancreas

 

157.2

Tail of pancreas

 

157.3

Pancreatic duct

 

157.4

Islets of Langerhans

 

157.8

Other specified sites of pancreas

 

157.9

Pancreas, part unspecified

 

162.2 – 162.9

Malignant neoplasm of bronchus and lung, code range

 

211.3

Benign neoplasm of colon

 

338.11 – 338.19

Acute pain, code range

 

338.21 – 338.29

Chronic pain, code range

 

338.3

Neoplasm related pain

 

338.4

Chronic pain syndrome

 

574.00

Calculus of gallbladder with acute cholecystitis, without mention of obstruction

 

574.01

Calculus of gallbladder with acute cholecystitis and obstruction

 

574.10

Calculus of gallbladder with other cholecystitis, without mention of obstruction

 

574.11

Calculus of gallbladder with other cholecystitis and obstruction

 

574.2

Calculus of gallbladder without mention of cholecystitis

 

574.3

Calculus of bile duct with acute cholecystitis

 

574.4

Calculus of bile duct with other cholecystitis

 

574.5

Calculus of bile duct without mention of cholecystitis

 

574.01

Calculus of gallbladder with acute cholecystitis and obstruction

 

574.6

Calculus of gallbladder and bile duct with acute cholecystitis

 

574.7

Calculus of gallbladder and bile duct with other cholecystitis

 

574.8

Calculus of gallbladder and bile duct with acute and chronic cholecystitis

 

574.9

Calculus of gallbladder and bile duct without cholecystitis

 

575.0

Acute cholecystitis

 

575.1

Other cholecystitis

 

575.2

Obstruction of gallbladder

 

575.3

Hydrops of gallbladder

 

575.4

Perforation of gallbladder

 

575.5

Fistula of gallbladder

 

575.6

Cholesterolosis of gallbladder

 

575.8

Other specified disorders of gallbladder

 

575.9

Unspecified disorder of gallbladder

 

576.0

Postcholecystectomy syndrome

 

576.1

Cholangitis

 

575.8

Other specified disorders of gallbladder

 

576.2

Obstruction of bile duct

 

576.3

Perforation of bile duct

 

576.4

Fistula of bile duct

 

576.5

Spasm of sphincter of Oddi

 

576.8

Other specified disorders of biliary tract

 

576.9

Unspecified disorder of biliary tract

 

577.0

Acute pancreatitis

 

577.1

Chronic pancreatitis

 

577.2

Cyst and pseudocyst of pancreas

 

577.8

Other specified diseases of pancreas

 

577.9

Unspecified disease of pancreas

 

V12.60 – V12.69

Personal history of diseases of the respiratory system, code range

 

V12.72

Diseases of digestive system, colonic polyps

 

V16.0

Family history of malignant neoplasm, gastrointestinal tract

 

V16.1

Family history of malignant neoplasm, trachea, bronchus, and lung

 

V18.51

Digestive disorders, colonic polyps

 

V76.0

Special screening for malignant neoplasms; respiratory organs

 

V76.51

Special screening for malignant neoplasms, colon

ICD-10-CM
(effective 10/1/14)

C15.3-C26.9

Malignant neoplasm of digestive organs, code range

 

C34.00-C34.92

Malignant neoplasm of bronchus and lung, code range

 

D01.0-D01.9

Carcinoma in situ of other and unspecified digestive organs, code range

 

D02.20-D02.22

Carcinoma in situ of bronchus and lung code range

 

D12.0-D13.9

Benign neoplasm of digestive system, code range

 

D14.30-D14.32

Benign neoplasm of bronchus and lung, code range

 

G56.40-G56.42

Causalgia of upper limb code range

 

G57.70-G57.72

Causalgia of lower limb code range

 

G89.0-G89.4

Pain, not elsewhere classified code range

 

G90.50-G90.59

Complex regional pain syndrome I code range

 

J40-J47.9

Chronic lower respiratory diseases code range

 

J96.09-J99

Other diseases of the respiratory system code range

 

K80.00-K87

Disorders of the gallbladder, biliary tract and pancreas, code range

 

M25.50-M25.579

Pain in joint code range

 

M54.00-M54.9

Dorsalgia code range

 

M79.60-M79.676

Pain in limb, hand, foot, fingers and toes code range

 

Z12.0 – Z12.13

Encounter for screening for malignant neoplasm of stomach or intestinal tract, code range

 

R52

Pain, unspecified

 

Z12.0 - Z12.13

Encounter for screening for malignant neoplasm of respiratory organs

 

Z12.2

Encounter for screening for malignant neoplasm of respiratory organs

 

Z13.811

Encounter for screening for lower gastrointestinal disorder

 

Z13.83

Encounter for screening for respiratory disorder NEC

 

Z80.0

Family history of malignant neoplasm of digestive organs

 

Z80.2

Family history of malignant neoplasm of other respiratory and intrathoracic organs

 

Z82.5

Family history of asthma and other chronic lower respiratory diseases

 

Z83.6

Family history of other diseases of the respiratory system

 

Z83.71 – Z83.79

Family history of diseases of the digestive system, code range

 

Z85.00-Z85.048

Personal history of malignant neoplasm of digestive organs code range

 

Z85.110-Z85.118

Personal history of malignant neoplasm of trachea, bronchus and lung code range

 

Z86.010

Personal history of colonic polyps

Appendix

N/A

History

Date

Reason

12/11/12

New policy. Replaces 7.02.01. This policy differs in that the policy statement is revised: Severe sleep apnea criterion previously requiring both oxygen and bi-pap now allows either oxygen or bi-pap as medically necessary. Further, for clarification, history of sleep apnea or stridor removed as an indication of anatomic variation. Policy Guidelines clarified with no significant change. Rationale and Reference sections updated.

05/13/13

Replace policy. Policy updated with literature review to January 16, 2013. The following policy statement was changed: The bullet point on patients of extreme age was changed to “patients younger than 18 years or 70 years or older”. Policy Guideline on “History of or intolerance to standard sedatives” clarified to state that chronic use of narcotic pain medication or prescription sedatives must be in dosages and/or frequency which would be expected to affect sedation requirements. References 12 and 20 added.

06/14/13

Update Related Policies. Add 11.01.504.

04/14/14

Interim review. Policy statement updated to indicated documentation from either the proceduralist “or” the anesthesiologist is sufficient, rather than from both. One record is acceptable now.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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