Ritalin Medication - Dosage, Description, Food effects, Indication and usage

 Ritalin


• The first ADHD medication used since 1950s

* Comes in 3 preparations

• Immediate release [IR] (lasting ~2-4 hours)

• Sustained release [SR] (~4-6 hours, seldom used)

• Long acting [LA] (~8 hours)

* Advantage of Ritalin LA versus Concerta is this may be opened and sprinkled on food

* Many times, the IR form will be used as a bridge for kids to get them through evenings and homework


Ritalin Dosing


• IR comes in 5 mg, 10 mg, 20 mg tabs

* Often patients will take every 4 hours if just using IR form

* Younger children often do better with smaller  amounts of IR medication if they cannot tolerate a  long-acting medication

• LA comes in 20 mg, 30 mg, 40 mg capsules

• Start low, generally do not exceed ~2 mg/kg/day




Stimulant and Related Medications: U.S. Food and Drug Administration-Approved Indications and Dosages for Use in Pediatric Patients

The therapeutic dosing recommendations for stimulant and related medications are based on U.S. Food and Drug Administration (FDA)-approved product labeling. Nevertheless, the dosing regimen is adjusted according to a patient’s individual response to pharmacotherapy. The FDA-approved dosages and indications for the use of stimulant and related medications in adults are provided in this table. All medication doses listed are for oral administration. Information on the generic availability of the stimulant and related medications can be found by searching the Electronic Orange Book at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm on the FDA website.


Medication Indication Age or Weight Dosing Information      Other Information       Generic Availability

methylphenidate ER (Ritalin LA®)†[20] 

ADHD 6 to 12 years

old Initial dose: 20 mg once a day; Maximum dose: 60 mg once a day in the morning.   

 May initiate treatment with 10 mg once a day based on clinical judgment; may increase daily dose by 10 mg at weekly intervals.                   

Yes


DESCRIPTION

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an extended-release

formulation of methylphenidate with a bi-modal release profile. Ritalin LA® uses the proprietary SODAS® (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Ritalin LA capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. Ritalin LA 10, 20, 30, and 40 mg capsules provide in a single dose the same amount of methylphenidate as dosages of 5, 10, 15, or 20 mg of Ritalin® tablets given b.i.d. 


CLINICAL PHARMACOLOGY

Pharmacodynamics

Methylphenidate hydrochloride, the active ingredient in Ritalin LA® (methylphenidate hydrochloride) extended-release capsules, is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the  release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. 


Pharmacokinetics Absorption


Ritalin LA produces a bi-modal plasma concentration-time profile (i.e., two distinct peaks approximately four hours apart) when orally administered to children diagnosed with ADHD and to healthy adults. The initial rate of absorption for Ritalin LA is similar to that of Ritalin tablets as shown by the similar rate parameters between the two formulations, i.e., initial lag time (Tlag), first peak concentration (Cmax1), and time to the first peak (Tmax1), which is reached in 1-3 hours. The mean time to the interpeak minimum (Tminip), and time to the second peak (Tmax2) are also similar for Ritalin LA given once daily and Ritalin tablets given in two doses 4 hours apart (see Figure 1 and Table 1), although the ranges observed are greater for Ritalin LA.


Ritalin LA given once daily exhibits a lower second peak concentration (Cmax2), higher interpeak minimum concentrations (Cminip), and less peak and trough fluctuations than Ritalin tablets given in two doses given 4 hours apart. This is due to an earlier onset and more prolonged absorption from the delayed-release beads (see Figure 1 and Table 1).


The relative bioavailability of Ritalin LA given once daily is comparable to the same total dose of Ritalin tablets given in two doses 4 hours apart in both children and in adults


Dose Proportionality

After oral administration of Ritalin LA 20 mg and 40 mg capsules to adults there is a slight upward trend in the methylphenidate area under the curve (AUC) and peak plasma concentrations (Cmax1 and Cmax2).


Elimination


In studies with Ritalin LA and Ritalin tablets in adults, methylphenidate from Ritalin tablets is eliminated from plasma with an average half-life of about 3.5 hours, (range 1.3 - 7.7 hours). In children the average half-life is about 2.5 hours, with a range of about 1.5 - 5.0 hours. The rapid halflife in both children and adults may result in unmeasurable concentrations between the morning and Reference ID: 2863882  mid-day doses with Ritalin tablets. No accumulation of methylphenidate is expected following multiple once a day oral dosing with Ritalin LA. The half-life of ritalinic acid is about 3-4 hours.


The systemic clearance is 0.40±0.12 L/h/kg for d-methylphenidate and 0.73±0.28 L/h/kg for lmethylphenidate. After oral administration of an immediate release formulation of methylphenidate, 78%-97% of the dose is excreted in the urine and 1%-3% in the feces in the form of metabolites within 48-96 hours. Only small quantities (<1%) of unchanged methylphenidate appear in the urine. Most of the dose is excreted in the urine as ritalinic acid (60%-86%), the remainder being accounted for by minor metabolites. 


Food Effects

Administration times relative to meals and meal composition may need to be individually titrated. When Ritalin LA was administered with a high fat breakfast to adults, Ritalin LA had a longer lag time until absorption began and variable delays in the time until the first peak concentration, the time until the interpeak minimum, and the time until the second peak. The first peak concentration and the extent of absorption were unchanged after food relative to the fasting state, although the second peak was approximately 25% lower. The effect of a high fat lunch was not examined.


There were no differences in the pharmacokinetics of Ritalin LA when administered with applesauce, compared to administration in the fasting condition. There is no evidence of dose dumping in the presence or absence of food.


For patients unable to swallow the capsule, the contents may be sprinkled on applesauce and administered (see DOSAGE AND ADMINISTRATION).


Special Populations

Age: The pharmacokinetics of Ritalin LA was examined in 18 children with ADHD between 7 and 12 years of age. Fifteen of these children were between 10 and 12 years of age. The time until the between peak minimum, and the time until the second peak were delayed and more variable in children compared to adults. After a 20-mg dose of Ritalin LA, concentrations in children were approximately twice the concentrations observed in 18 to 35 year old adults. This higher exposure is almost completely due to the smaller body size and total volume of distribution in children, as apparent clearance normalized to body weight is independent of age.


Gender: There were no apparent gender differences in the pharmacokinetics of methylphenidate between healthy male and female adults when administered Ritalin LA.


Renal Insufficiency: Ritalin LA has not been studied in renally-impaired patients. Renal insufficiency is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity.


Hepatic Insufficiency: Ritalin LA has not been studied in patients with hepatic insufficiency. Hepatic insufficiency is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body. 


INDICATIONS AND USAGE


Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).


The efficacy of Ritalin LA in the treatment of ADHD was established in one controlled trial of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).


A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type,

at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met. 


Need for Comprehensive Treatment Program


Ritalin LA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial

intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.


Long-Term Use

The effectiveness of Ritalin LA for long-term use, i.e., for more than 2 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Ritalin LA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). 



CONTRAINDICATIONS

Agitation

Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is contraindicated in marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.


Hypersensitivity to Methylphenidate

Ritalin LA is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product.


Glaucoma

Ritalin LA is contraindicated in patients with glaucoma.


Tics

Ritalin LA is contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome. (See ADVERSE REACTIONS.)


Monoamine Oxidase Inhibitors

Ritalin LA is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (hypertensive crises may result). 


Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm

less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In the double-blind placebo-controlled study of Ritalin LA® (methylphenidate hydrochloride) extended-release capsules, the mean weight gain was greater for patients receiving placebo (+1.0 kg) than for patients receiving Ritalin LA (+0.1 kg). Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 



Use in Children Under Six Years of Age


Ritalin LA should not be used in children under six years of age, since safety and efficacy in this agegroup have not been established.


Drug Dependence

Ritalin LA should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. 


Information for Patients


Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Ritalin LA. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.


Drug Interactions


Methylphenidate is metabolized primarily by de-esterification (nonmicrosomal hydrolytic esterases) to ritalinic acid and not through oxidative pathways. The effects of gastrointestinal pH alterations on the absorption of methylphenidate from Ritalin LA have not been studied. Since the modified release characteristics of Ritalin LA are pH dependent, the coadministration of antacids or acid suppressants could alter the release of methylphenidate. 


Pregnancy Category C


In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2  basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2

 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2  basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m2  basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (4 times the MRHD on a mg/m2  basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (equal to the MRHD on a mg/m2  basis).


Adequate and well-controlled studies in pregnant women have not been conducted. Ritalin LA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Nursing Mothers


It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Ritalin LA is administered to a nursing woman.


Pediatric Use

Long-term effects of methylphenidate in children have not been well established. Ritalin LA should not be used in children under six years of age (see WARNINGS).


In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13­ 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a

mg/m2  basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the MRHD on a mg/m2

 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2  basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.


ADVERSE REACTIONS


The clinical program for Ritalin LA® (methylphenidate hydrochloride) extended-release capsules consisted of six studies: two controlled clinical studies conducted in children with ADHD aged 6-12 years and four clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight. 



Methylphenidate Basics


• Medication inhibits Norepinephrine and Dopamine transporters

• Short ½ life: 2-4 hours

* First developed in 1944, Ritalin has been used in ADHD  since the 1960s

* Due to the short half-life, an industry has arisen trying to  get the medication to last longer and be delivered more  evenly



Metadate

• Very similar to Ritalin

* Controlled Dosing [CD] usually lasts ~8 hours and is comparable to Ritalin LA

• Can be opened and sprinkled

• Often insurance companies will approve one or the other

* Extended Release [ER] is comparable to Ritalin SR

• Lasts 4-6 hours

• Seldom used



CPT 44360, 44361, 44376, 44377, 44365, Enteroscopy codes

Code1 Code Description


44360   Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, not including ileum; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) $663.06


44361 Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, not including ileum; with biopsy, single or multiple $663.06


44376   Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, including ileum; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)


44377 Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, including ileum; with biopsy, single or multiple


44365 Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, not including ileum; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery 


Enteroscopy


A new definition and instructions for reporting antegrade transoral small intestine endoscopy (i.e., enteroscopy) have been added to the section guidelines. Enteroscopy is defined by the most distal segment of small intestine that is examined; coding does not reflect the technology used to perform the examination.

Codes in the 44360 family for enteroscopy, not including ileum (44360–44373), are endoscopic procedures to visualize the esophagus through the jejunum using an antegrade approach. Codes in the 44376 family for enteroscopy, including ileum (44376–44379), are endoscopic procedures to visualize the esophagus through the ileum using an antegrade approach.


If an endoscope cannot be advanced at least 50 cm beyond the pylorus, see the appropriate code in the EGD family (43233, 43235–43259, 43266, 43270). If an endoscope can be passed at least 50 cm beyond pylorus, but only into jejunum, see the appropriate code in the enteroscopy, not including ileum family (44360–44373).

To report retrograde examination of small intestine via anus or colon stoma, use 44799, Unlisted procedure, small intestine. 

There were no changes to the language of the individual CPT codes.


If an endoscopy or enteroscopy is performed as a common standard of practice when performing another service, the endoscopy or enteroscopy is not separately reportable. For example, if a small intestinal endoscopy or enteroscopy is performed during the creation or revision of an enterostomy, the small intestinal endoscopy or enteroscopy is not separately reportable.


Upper Endoscopy

• Esophagoscopy  Only view esophagus to LES

• Esophagogastroduodenoscopy

* Standard procedure

* Esophagus – stomach – duodenal bulb – 2 nd part

duodenum

• Push enteroscopy

* Using pediatric colonoscopy

* Advance to Jejunum



Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.



It is important to remember that surgical endoscopy always includes a diagnostic endoscopy (CPT® Code 43200). Therefore, when a diagnostic endoscopy is performed during the same session as a surgical endoscopy, the diagnostic endoscopy code is not separately reported. (CPT Assistant, October 2001)


BACKGROUND


Enteroscopy refers to endoscopic examination of the small intestine. Although limited small-bowel evaluation is undertaken during EGD and is possible during colonoscopy, enteroscopy typically refers to more extensive endoscopic examination of the small intestine, extending into the jejunum and/or ileum. Diagnostic evaluation of the small bowel can be performed by noninvasive imaging (CT or magnetic resonance enterography) or by wireless capsule endoscopy (WCE). Whereas these modalities currently lack therapeutic ability, they often precede and serve to guide and direct therapy via enteroscopy. WCE was discussed in a previous ASGE Technology Committee document.1 This document will focus on endoscopes, devices, and techniques used for enteroscopy and represents an update of a previous ASGE Technology Status Evaluation Report titled “Enteroscopes.”


TECHNOLOGY UNDER REVIEW

Push enteroscopy

This procedure may be performed with a specifically designed enteroscope or by using a colonoscope with or without an overtube. Typically evaluation is limited to

the proximal jejunum.

Device-assisted enteroscopy

Deeper evaluation of the small bowel can be accomplished with enteroscopes coupled with a specialized overtube apparatus. The procedure can be performed via an

antegrade approach (via the mouth) or via a retrograde approach (via the anus). In the United States, current options for device-assisted enteroscopes include doubleballoon enteroscopy (DBE), single-balloon enteroscopy (SBE), and spiral enteroscopy. A newer through-the-scope balloon-assisted device that allows “on-demand” enteroscopy is also available.


Intraoperative enteroscopy

This is a technique in which an endoscope is inserted orally or via an enterotomy and is guided through the small bowel with surgical assistance.


TECHNICAL CONSIDERATIONS


Certain general principles and techniques applicable to all forms of enteroscopy deserve consideration. Foremost, mucosal inspection should be accomplished during both

insertion and withdrawal because minor mucosal abrasions caused by instrumentation can mimic vascular or inflammatory lesions. Second, the use of fluoroscopy to assess

enteroscope and/or overtube position, and advancement varies and depends on many factors including the type of enteroscopy being performed, the approach (antegrade

vs retrograde), the indication, and endoscopist preference.


Although fluoroscopy was widely used previously, many endoscopists currently perform enteroscopy without fluoroscopic guidance. Finally, an important variable is the

use of CO2 for insufflation rather than air because studies specific to enteroscopy have shown enhanced insertion depth and better patient tolerance with CO2 insufflation.3-6 The technical specifications of push and deviceassisted enteroscopes and overtubes are listed in Tables 1 and 2.


Push enteroscopes


Push enteroscopy may be performed with dedicated enteroscopes or by using colonoscopes. Push enteroscopes are longer versions of standard endoscopes with a working

length of 200 to 250 cm, external diameters of 10.5 to 11.7 mm, and channel diameters of 2.8 to 3.8 mm. However, the length of the instrument does not necessarily correlate with deeper insertion or improved diagnostic yield.7 The use of overtubes has been proposed to allow for greater insertion depth during push enteroscopy; however, it is again unclear whether this results in a greater diagnostic yield.8-10 Overtubes are not routinely used because of greater patient discomfort and reported adverse events related to their use.9-12 Overtubes have been detailed in a separate ASGE Technology Committee document.13


Technique. The endoscope is introduced through the mouth and advanced into the small bowel as far as possible until looping limits forward progression. Torque

and withdrawal are performed to reduce loops, and the endoscope is then re-advanced and the process is repeated. If the endoscope cannot be advanced further

with these maneuvers, patient position can be changed and abdominal pressure can be applied. If a variablestiffness colonoscope is used, stiffening of the instrument

may allow further advancement. In procedures in which an overtube is used, it is backloaded up to the hub of the endoscope before insertion. The endoscope is then

advanced to the second or third portion of the duodenum, and loop reduction is then performed. The overtube is then advanced to the level of the tip of the endoscope,

and the endoscope is then re-advanced further. Fluoroscopy may guide loop reduction, assessment of endoscope position, and advancement.


Device-assisted enteroscopy

Double-balloon enteroscopes. DBE was first introduced in 2001 and was developed for evaluation of the entire jejunum and ileum. DBE uses a specially coupled enteroscope and overtube apparatus with latex balloons mounted on the distal ends of each component. The balloons are intended to anchor the endoscope in position during insertion to allow for pleating of the bowel over the endoscope shaft, reducing loop formation and allowing for greater insertion depth. Three DBE systems are currently available. The most commonly used system is an enteroscope with a 9.4-mm diameter, a 2.8-mm working channel, and a 200-cm working length (EN-450T5; Fujinon, Saitama, Japan). DBE systems designed with a smaller diameter (EN-450P5/20) and shorter length (EC-450BI5) are detailed in Table 1. The smaller diameter system may be used for pediatric patients and for diagnostic procedures in adults. The shorter length system has been used to perform ERCP in patients with postsurgical anatomy.

The soft overtube of the most commonly used DBE system (EN-450T5; Fujinon) has a length of 145 cm, an outer diameter of 13.2 mm, and a specifically designed pump for inflating and deflating the latex balloon at its tip. Additional available overtubes used with the smaller diameter and shorter length DBE enteroscopes are detailed in Table 2.


A balloon pump controller (PB-20; Fujinon) controls the internal dilation pressure of both enteroscope and overtube balloons, monitoring it and setting it at 5.6 kPa. Increased pressure within the balloon triggers an alarm. If the alarm is not acknowledged and silenced by the endoscopist or assistant, autodeflation of both balloons occurs.


Technique. DBE is a 2-person procedure, requiring an endoscopist and an assistant. After the overtube is loaded onto the enteroscope, a soft latex balloon is attached to the tip of the enteroscope. The balloons are deflated at the initiation of the procedure. For the antegrade approach, the endoscope and overtube are advanced to the duodenum past the major papilla, and the overtube balloon is inflated to maintain a stable position. The enteroscope is then advanced up to 40 cm distal to the overtube tip, and its balloon is inflated to anchor the enteroscope. The overtube balloon is then deflated, and the overtube is advanced toward the tip of the enteroscope. The overtube balloon is then reinflated such that the entire apparatus is secured to the intestine with both balloons inflated. The enteroscope-overtube apparatus is then retracted simultaneously so as to pleat the intestine along the overtube like an accordion. This sequence is repeated, and the device is advanced through the intestine in 40-cm increments (Fig. 1). When the desired or maximum insertion distance is reached, a submucosal tattoo is often placed to mark the distal extent of the evaluation.


Withdrawal of the apparatus is generally performed in short segments to allow for careful mucosal inspection. Withdrawal is initiated with the endoscope balloon inflated and the overtube balloon deflated. After withdrawal of the overtube, the overtube balloon is reinflated. Endoscope retraction is always performed with the overtube secured by its inflated balloon to prevent uncontrolled loss of depth of insertion.14,15 A circumferential white marking on the enteroscope 140 cm proximal to the balloon represents a marker beyond which the overtube should not be advanced or the enteroscope withdrawn. This is to prevent the overtube from shearing off the enteroscope balloon during insertion or withdrawal (Fig. 2). DBE was often performed previously with fluoroscopic guidance, although this is currently less commonly used.


For retrograde DBE, a colonoscopy preparation is required. The enteroscope and overtube are advanced to the cecum either directly or by using the previously described push-pull technique. With the overtube balloon inflated, the enteroscope is advanced across the ileocecal valve and its balloon inflated within the ileum. The overtube is then advanced into the ileum with its balloon deflated. Subsequently, the advancement steps are identical to those of the antegrade DBE technique previously described. DBE may allow complete enteroscopy, defined as endoscopic evaluation of the entire small bowel with a single approach or by combining antegrade and retrograde approaches.


Single-balloon enteroscopes. SBE was introduced in 2007, and it uses an enteroscope with an overtube (SIF-Q180; Olympus America Inc, Center Valley, Pa) and an electronic balloon inflation control device that allows automatic pressure control. In contrast to DBE, only the disposable overtube has a nonlatex balloon at its distal end. The enteroscope has a working length of 200 cm, an outer diameter of 9.2 mm, and a 2.8-mm diameter working channel. The overtube (ST-SB1; Olympus) is 140 cm long with a 13.2-mm outer diameter, and its distal end has an inflatable silicone balloon. The balloon is controlled by pressing buttons on the front panel of the Olympus balloon control unit or on a remote control. The balloon pressure is regulated to 5.4 kPa. The internal surface of the overtube is hydrophilic, and lubrication between the outer surface of the enteroscope and the inner surface of the overtube is facilitated by flushing the internal surface of the overtube with water.


Technique. The technique for SBE is similar to that for DBE. The overtube is backloaded onto the enteroscope, and the enteroscope is advanced as far as possible into

the small bowel, then anchored by using its flexible tip (as opposed to enteroscope tip balloon-assisted anchoring used in DBE). Subsequently, the overtube is advanced with its balloon deflated to the tip of the enteroscope. The overtube balloon is then inflated while keeping the enteroscope tip flexed. The entire apparatus is then withdrawn to allow pleating of the small bowel over the enteroscope and overtube. The enteroscope is then re-advanced while keeping the overtube balloon inflated to prevent slippage of the proximal bowel that has been pleated on the overtube. When the enteroscope cannot be advanced further, its tip is again flexed to anchor the enteroscope. The overtube balloon is then deflated, and the overtube is again advanced to the tip of the enteroscope. This sequence is repeated until the apparatus has advanced to the maximal, or to the desired extent within the small intestine (Fig. 3). The point of final enteroscope advancement can be marked with a submucosal tattoo.


Spiral enteroscopes. Spiral enteroscopy was developed in 2007 potentially to provide a simpler and faster technique compared with balloon-assisted enteroscopy. It uses a disposable overtube with a soft raised spiral ridge that is designed to pleat the small bowel. The overtube is 118 cm long with soft raised spiral helix at its distal end that is either 4.5 mm (low profile) or 5.5 mm (standard profile) in height. The overtube is compatible with enteroscopes that are 200 cm in length and between 9.1 and 9.5 mm in diameter. Two different overtubes are available for antegrade (Endo-Ease Discovery SB; Spirus Medical Inc, Stoughton, Mass) or retrograde (Endo-Ease Vista; Spirus Medical Inc) examinations. The overtube has a coupling device on its proximal end that affixes itself to the enteroscope. This allows for free rotation of the overtube independent of the enteroscope but prevents independent movement of the enteroscope (advancement or withdrawal) relative to the overtube. When the overtube is uncoupled, the enteroscope can then be advanced or withdrawn independent of the overtube. A motorized spiral enteroscopy system is in development.


Technique. Two operators are required to perform the procedure: an endoscopist and an assistant to operate the overtube. Before insertion, the inner lining of the overtube is generously lubricated with the proprietary lubricant supplied with the device. The overtube is then backloaded onto the enteroscope so that about 20 cm of the enteroscope protrudes past the distal tip of the overtube. When the overtube and enteroscope are coupled, the overtube should be rotated clockwise for advancement and counterclockwise for withdrawal. For antegrade examination, the overtube and enteroscope are advanced slowly with clockwise rotation of the overtube until the enteroscope tip ideally reaches the ligament of Treitz. It is important to minimize insufflation of air or CO2, which decreases the chance of loop formation in the stomach and allows for better contact of the spiral helix to the small intestine to initiate movement and pleating of the intestine onto the overtube. Resistance to rotation of the overtube is usually due to loop formation in the stomach. This can be countered by continued slow clockwise rotation of the overtube while gently pulling back (withdrawing) the overtube. This reduction maneuver along with application of external abdominal pressure or splinting can be used to advance the overtube-enteroscope unit into the small intestine. When resistance to further clockwise overtube rotation is encountered and deeper advancement is not thought to be possible, the enteroscope can be uncoupled from the overtube and further advanced to its maximal depth. Withdrawal of the enteroscope is performed by pulling back the enteroscope so that its tip is 20 cm distal to the overtube tip. At this point, it is recoupled, and further withdrawal is done by counterclockwise rotation of the overtube. For retrograde examinations, the technique is similar to antegrade examination.


On-demand enteroscope. The NaviAid (SMART Medical Systems Ltd, Ra’anana, Israel) is a newer device that consists of a disposable balloon component that is advanced through the working channel of an endoscope or colonoscope (NaviAid AB and NaviAid ABC) and an air supply unit. The NaviAid AB has a working length of 350 cm with a balloon diameter of 40 mm. The minimum endoscope working channel diameter needed for passage of the device is 3.8 mm. The inflation/deflation of the balloon is controlled by an air supply unit, and balloon pressure is regulated at 6 kPa. The balloon device can be advanced through the instrument channel of the endoscope only when deep enteroscopy is needed. It does not require any specific premounting or preprocedural preparation.


Technique. The procedure technique is conceptually similar to balloon-assisted enteroscopy with an overtube. The balloon is advanced beyond the tip of the endoscope through its instrument channel and inflated to anchor itself to the small intestine. Subsequently, repetitive push-pull maneuvers are performed with the endoscope sliding over the catheter as a rail until it reaches the inflated balloon distally. The balloon catheter can be removed to allow for therapeutic interventions as needed and reinserted for further advancement.


Intraoperative enteroscopy. Intraoperative enteroscopy is the most invasive of the enteroscopy techniques but can allow for complete evaluation of the small intestine. Due to significant advancements in noninvasive imaging and device-assisted enteroscopy, it is performed less frequently. The technique can be quite variable with regard to the location of endoscope insertion, the type of endoscope used, and the approach to intra-abdominal access (laparotomy vs laparoscopy). It is performed in the operating room with the assistance of a surgical team while the endoscopist performs the enteroscopy. The surgeon pleats segments of intestine over the enteroscope via a laparotomy or with laparoscopic techniques. Lesions can be treated endoscopically or marked for surgical resection.


INDICATIONS


The most common indication for all types of enteroscopy is the diagnosis and/or therapy of obscure overt or occult intestinal bleeding, ie, bleeding without an etiology found on standard upper endoscopy and colonoscopy with terminal ileoscopy.8 Other indications include evaluation of imaging abnormalities raising concern for small-bowel Crohn’s disease, strictures, ulcers, celiac disease, malabsorption, polyps, masses, lymphoma, and other infiltrative diseases.24-30 Therapeutic indications in addition to hemostasis include polypectomy, retrieval of foreign bodies, enteral stricture dilation, placement of jejunal feeding tubes, treatment of early postoperative small-bowel obstruction, and performance of ERCP in patients with postsurgical anatomy.


EFFICACY AND COMPARATIVE STUDIES


Push enteroscopy

Push enteroscopy offers the advantage of wide availability because it does not require specialized equipment or training. Currently, it is usually performed for investigation of upper small-bowel lesions up to the proximal jejunum as determined by previous imaging or not within reach of standard EGD. The average depth of intubation at push enteroscopy can be estimated from reports without standardized methodologies. The extent of jejunal intubation has been reported to be approximately 45 to 60 cm beyond the ligament of Treitz with a colonoscope, 25 to63 cm with an enteroscope, and 46 to 80 cm with an enteroscope through an overtube.7,9,35-42 The diagnostic yield of push enteroscopy for obscure GI bleeding ranges from 20% to 80%.43 However, many lesions found during push enteroscopy are within reach of a standard gastroscope,44 and the true diagnostic yield of push enteroscopy may be more in the 15% to 40% range.45 Overt bleeding has been found to be predictive for positive findings at push enteroscopy, which can change management in 40% to 75% of patients in this setting.46-51 Studies evaluating long-term outcomes of patients undergoing push enteroscopy have shown conflicting results. One study indicated that recurrent rebleeding occurs in 33% of patients, with a trend toward frequent rebleeding in patients with angioectasias.52 Some studies indicate that therapy of angioectasias can reduce transfusion requirements and improve quality of life,50,53-55 but others have not shown similar results.


Several studies compared push enteroscopy with WCE. In compiled comparative studies that included 216 patients with bleeding of unknown origin or suspected small-bowel disease, a diagnosis was made with push enteroscopy in 29% of patients and with WCE in 68% of patients.38-40,58-60 Clinical management was changed in 9% and 39% of patients diagnosed with push enteroscopy and WCE, respectively.39,40,58 In 2 series, all lesions diagnosed by push enteroscopy were also seen by WCE, but most of the lesions seen by WCE and not by push enteroscopy were distal to the reach of the enteroscope.39,58 However, in a study of patients with familial adenomatous polyposis, push enteroscopy detected many more polyps than WCE, even though the latter examined far more of the intestine. WCE did not visualize the ampulla of Vater in all patients and missed many polyps larger than 10 mm as well as large submucosal tattoos.61 In a separate study with follow-up of 1 year or more after diagnosing small-bowel disease, the sensitivity and specificity of push enteroscopy were 48% and 80%, respectively, and for WCE, they were 92% and 69%, respectively (P < .01).62

Meta-analysis data also indicate that capsule endoscopy is superior to push enteroscopy for the diagnosis of smallbowel pathology, with a 35% to 40% incremental yield and a number needed to treat of 3.


Double-balloon enteroscopy


Most published data on balloon-assisted enteroscopy come from DBE studies. Most studies have focused on patients with obscure GI bleeding, but a few have compared

DBE with other small-bowel imaging modalities.14,15,24,28,42,65-73 The mean reported procedure times range from 73 to 123 minutes.24,65,71,74,75 The estimated depth of insertion for the antegrade approach is reported to be between 220 to 360 cm and for the retrograde approach between 124 to 183 cm.24,65,71,74,75 Reported rates of complete enteroscopy vary widely. Whereas Japanese studies have reported complete enteroscopy rates in the 70% to 86% range, Western series have generally reported lower rates.14,65,74-80 Reported diagnostic yields have ranged from 40% to 80%, with therapeutic yields of 15% to 55%.24,65,71,74,75,81 A large study of 2245 DBEs performed in 1765 patients revealed that diagnostic yield varied with the indication. Rates were highest for patients with PeutzJeghers syndrome and lowest when the indication for the procedure was diarrhea.79 In patients with angioectatic lesions, DBE has been shown to allow effective treatment, although recurrent bleeding is common.82,83 In 1 study of 50 patients, 88% of whom were treated for angioectasias and followed for a mean duration of 55 months, mean hemoglobin levels increased from a pretreatment level of 7.6 to 11.0 g/dL after treatment. There was an associated significant decrease in transfusion requirements. However, the rebleeding rate was 48% in patients treated with argon plasma coagulation.82 In another study of 98 patients with treated angioectasias, rebleeding occurred in 46% of patients at 36 months. Factors associated with increased rates of rebleeding were the presence of a larger number of angioectasias and underlying cardiac disease.83


Some studies compared DBE with capsule endoscopy and push enteroscopy. A comparative meta-analysis of DBE and capsule endoscopy indicated a similar yield of clinically significant small-bowel findings (60% and 57%).84 Comparison of DBE and push enteroscopy indicates a superior diagnostic yield with DBE that is thought to be related to higher rates of complete small-bowel visualization.


Single-balloon enteroscopy

The efficacy of SBE is generally similar to that of DBE. Reported diagnostic yields have ranged from 41% to 65% and therapeutic yields from 7% to 50%.85-94 The reported range for depth of insertion is 133 to 270 cm for antegrade examinations and 73 to 199 cm for retrograde examinations.86,89,91,92,94 Studies suggest that the rate of total enteroscopy with SBE may be lower than that with DBE by 0% to 24%.86-88,93 This may be because of the difficulty in maintaining enteroscope position in the small bowel as the overtube is advanced due to lack of a specific anchoring mechanism for the SBE enteroscope.


Spiral enteroscopy

Reports on spiral enteroscopy suggest decreased procedure times compared with balloon-assisted enteroscopy.92,95-99 Data from 3 studies including a total of 183 patients (of whom 171 successfully underwent the procedure) indicated mean depths of insertion ranging from 175 to 262 cm, mean procedure times of 34 to 37 minutes,

and diagnostic yields of 12% to 59%.95-97 With regard to diagnostic yield, in 1 of these studies, the primary indication was diarrhea; hence, the diagnostic yield was low at 12%.96 The other 2 studies indicated diagnostic yields of 33% and 59%.95,97


A comparison study of WCE and spiral enteroscopy in 56 patients who had positive capsule findings indicated that the yield of spiral enteroscopy was 54%. The type of finding on capsule endoscopy was associated with reproducibility on spiral enteroscopy, with fresh bleeding being the most reproducible, followed by angioectasias.100 Another study that examined long-term outcomes in 78 patients who underwent spiral enteroscopy for obscure GI bleeding found that deep small-bowel spiral enteroscopy was safe and effective and led to a statistically significant reduction in the incidence of overt bleeding from 62% to 26%.101


CPT code for Esophagogastroduodenoscopy (EGD) - 43235 - 43259

 What is an Esophagogastroduodenoscopy (EGD)?


It is an endoscopic procedure that visualizes the upper part of the gastrointestinal tract up to the duodenum.

CPT© codes in this series (43235- 43259) identify services performed during an esophagogastroduodenoscopy.



CPT Codes for Esophagogastroduodenoscopy


CPT Code Code Descriptor


43235 Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed

43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43237 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures

43238 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine-needle aspiration/biopsy(s), (includes endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures) 

43239 Esophagogastroduodenoscopy, flexible, transoral; biopsy; single or multiple

43240 Esophagogastroduodenoscopy, with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed)

43241 Esophagogastroduodenoscopy, flexible, transoral; insertion of intraluminal tube or catheter

43242 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine-needle aspiration/biopsy(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis)

43243 Esophagogastroduodenoscopy, flexible, transoral; injection sclerosis of esophageal/gastric varices

43244 Esophagogastroduodenoscopy, flexible, transoral; band ligation of esophageal/gastric varices

43245 Esophagogastroduodenoscopy, flexible, transoral; with dilation of gastric/duodenal stricture(s) (eg, balloon, bougie)

43246 Esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube

43247 Esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body(s)

43248 Esophagogastroduodenoscopy, flexible, transoral; insertion of guide wire followed by passage of dilator(s) through esophagus over guide

43249 Esophagogastroduodenoscopy, flexible, transoral; transendoscopic balloon dilation of esophagus (<30 mm)

43233 Esophagogastroduodenoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed)

43250 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps

43251 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

43252 Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy

43253 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided transmural injection of diagnostic or therapeutic substance(s) (eg, anesthetic, neurolytic agent) or fiducial marker(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis) 

43254 Esophagogastroduodenoscopy, flexible, transoral; with EMR (endoscopic mucosal resection)

43255 Esophagogastroduodenoscopy, flexible, transoral; with control of bleeding, any method

43256 43256 has been deleted. To report, use 43266

43266 Esophagogastroduodenoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and postdilation and guide wire passage, when performed)

43257 Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease

43258 43258 has been deleted. To report, use 43270

43270 Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed)

43259 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination, including the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis.


Esophagogastroduodenoscopy (EGD) – CPT© Codes 43235-43270


The American Society for Gastrointestinal Endoscopy (ASGE) works to ensure that adequate methods are in place for gastroenterology practices to report and obtain fair and reasonable reimbursement for procedures, tests and visits. To assist practices in understanding and implementing GI-specific coding, ASGE has developed coding sheets.The purpose of the coding sheet is to provide a high-level overview to support practices in there coding and reimbursement for 2018.


GUIDELINES

This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.



DESCRIPTION


Upper gastrointestinal (GI) endoscopy, or esophagogastroduodenoscopy (EGD) is usually performed to evaluate symptoms of persistent upper abdominal pain, nausea, vomiting, and difficulty swallowing or bleeding from the upper GI tract. EGD is more accurate than x-ray films for detecting inflammation, ulcers, or tumors of the

esophagus, stomach and duodenum and can detect early cancer, as well as distinguish between benign and malignant conditions when biopsies of suspicious areas are obtained.


Esophagogastroduodenoscopy (EGD) uses a flexible fiber-optic scope with a light and camera to examine the upper part of the GI system. The scope is inserted through the mouth into the upper GI tract allowing for direct visualization of the esophagus, stomach, and duodenum through the camera. This document does not address

upper gastrointestinal (GI) endoscopy in children, wireless capsule endoscopy, virtual endoscopy or in vivo analysis of gastrointestinal lesions via endoscopy.



Gastroenterological procedures included in CPT code ranges 43753-43757 and 91010-91299 are frequently complementary to endoscopic procedures. Esophageal and gastric washings for cytology when performed are integral components of an esophagogastroduodenoscopy (e.g., CPT code 43235). Gastric or duodenal intubation with or without aspiration (e.g., CPT codes 43753, 43754, 43756) shall not be separately reported when performed as part of an upper gastrointestinal endoscopic procedure. Gastric or duodenal stimulation testing (e.g., CPT codes 43755, 43757) may be facilitated by gastrointestinal endoscopy (e.g., procurement of gastric or duodenal specimens).

When performed concurrent with an upper gastrointestinal endoscopy, CPT code 43755 or 43757 should be reported with modifier 52 indicating that a reduced level of service was performed.


GI Topics of Discussion


• Anatomy of the Upper Gastrointestinal Tract

• Esophagoscopy

• Esophageal Dilation

• Esophagogastroduodenoscopy

• EGD with procedures

• Anatomy of the Lower Gastrointestinal Tract

• Colonoscopy

• Colonoscopy with procedures

Upper Gastrointestinal Endoscopy

• Esophagogastroduodenoscopy

* Acronym = EGD

* Direct visual examination of the upper gastrointestinal tract by means of a flexible fiberoptic endoscope

* EGD describes a procedure in which the pyloric channel is traversed with the endoscope

* Code range 43235 - 43259



Deleted Codes


Three codes have been deleted in the esophagoscopy family.

Code 43219 – Stent or tube placement has been deleted; use new code 43212 to report Esophagoscopy, flexible, transoral; stent placement. The new code specifies the inclusion of pre- and post-dilation and guide wire passage when performed and includes moderate sedation as indicated by the moderate sedation symbol.

Code 43228 – Ablation of tumor has been deleted. A new code has been established for ablation of tumors with esophagoscopy (43229). The new code include pre- and post-dilation and guide wire passage when performed. Moderate sedation is included, as indicated by the moderate sedation symbol.

Code 43234, which described a simple primary upper endoscopy, has been deleted. To report a diagnostic esophagogastroduodenoscopy, 43235 should be reported, or one of the three diagnostic esophagoscopy codes as appropriate.


Guide Wire and Dilation


The EGD family includes a code for insertion of guide wire followed by dilation over guide wire. Insertion of guide wire code 43248 has been revised to describe passage of dilator(s) over a guide wire rather than dilation. Codes 43248 and 43249 (dilation codes) should not be reported with codes 43266 and 43270, as these codes (stent, ablation) include dilation.


Endoscopic Ultrasound (EUS)


Endoscopic ultrasound (EUS) examination codes 43237 and 43238 have been revised to describe EUS limited to the esophagus, stomach or duodenum and adjacent structures. Endoscopic ultrasound codes 43242 and 43259 have been revised to include examination of a surgically altered stomach where the jejunum is examined distal to the anastomosis. Clarification language has been included to address the extent of performance of the EUS examination as distinguished from the extent of the endoscopic visualization.


Pseudocyst Drainage


In addition to transmural drainage of pseudocyst as described in the current code 43240, EGD with transmural drainage of pseudocyst has been revised to specify that it includes endoscopic ultrasound, transmural drainage and placement of stent(s) to facilitate drainage, when performed.


Dilation Procedures

Dilation procedure codes have been added, revised and deleted to better describe current practice. EGD code 43249 has been revised to specify transendoscopic balloon dilation of less than 30 mm in diameter. Code 43233 (>30mm balloon, e.g., achalasia) includes fluoroscopic guidance, when used. Code 43245 has been revised

to describe dilation of gastric/duodenal stricture(s) and the guide wire example has been removed from the examples in parentheses. Code 43233 includes moderate sedation, as indicated by the moderate sedation symbol.


Control of Bleeding

The parentheticals for code 43255, EGD with control of bleeding code 43255 have been revised. Code 43255 should not be reported for treatment of esophageal/gastric varices, which are reported with more specific codes 43243 (sclerotherapy) or 43244 (banding). Code 43236, submucosal injection, would also not be reported if injection was part of the control of bleeding procedure.


New Codes

Balloon Dilation of Esophagus

EGD code 43233 (out of sequence) has been established to report balloon dilation of 30 mm in diameter or larger. This dilation procedure includes fluoroscopic guidance, when used. 



Endoscopic Mucosal Resection


Code 43254 has been established to report endoscopic mucosal resection (EMR) with EGD. Code 43254 includes removal of tumor(s), polyp(s) or other lesion(s) by snare technique (43251); directed submucosal injection(s) (43236); and band ligation (43254), so these services are not separately reportable when performed on the same

lesion during the same session. Biopsy (43239) performed on the same lesion as EMR is not separately reportable. Code 43254 includes moderate sedation, as indicated by the moderate sedation symbol.


Ultrasound-Guided Injections / Placement of Fiducial Markers


Code 43253 has been established to describe ultrasound-guided transmural injection of substances (e.g., celiac axis injection) or fiducial markers. This code includes endoscopic ultrasound (EUS) of the esophagus, stomach, and either the duodenum or a surgically-altered stomach where the jejunum is examined distal to the anastomosis.

Ablation of Tumors A new code has been established for EGD with ablation (43270). The new code includes pre- and post-dilation and guide wire passage when performed. Separate reporting of pre- or post-dilation or guide wire passage when performing ablation of the same lesion during the same session would not be appropriate. Ablation procedures are reported without a reduced services modifier 52, even if all three components (pre-dilation, post-dilation or guide wire passage) are not performed during the same session.


Placement of Stent

Revised code descriptor language for placement of an endoscopic stent in the esophagus states “pre-and postdilation and guide wire passage, when performed”. Code 43266, EGD with placement of stent is reported without a reduced services modifier 52, even if all three components (pre-dilation, post-dilation, and guide wire passage) are not performed during the same session. Separate reporting of pre-dilation, post-dilation or guide wire passage of the same lesion during the same session would not be appropriate.



Modifier 33 – Preventive Services usage and guideline policy

 Modifier code and Description


Modifier 33 – Preventive Services: 


Preventive Services: When the primary purpose of the service is the delivery of an evidence based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be identified by adding 33 to the procedure. For separately reported services specifically identified as preventive, the modifier should not be used.


Tips for Billing CPT Modifier 33


The modifier 33 was created to aid compliance with the Affordable Care Act (ACA) which prohibits member cost sharing for defined preventive services for nongrandfathered health plans. The appropriate use of modifier 33 reduces claim adjustments related to preventive services and your corresponding refunds to members.


Modifier 33 is applicable to CPT codes representing preventive care services. CPT codes not appended with modifier 33 will process under the member’s medical or

preventive benefits, based on the diagnosis and CPT codes submitted.


Modifier 33 should be appended to codes represented for services described in the US

Preventive Services Task Force (USPSTF) A and B recommendations, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and

Prevention (CDC), and certain guidelines for infants, children, adolescents, and women supported by the Health Resources and Services Administration (HRSA) Guidelines.


The CPT® 2016 Professional Edition manual shares the following information regarding the billing of modifier 33, “When the primary purpose of the service is the delivery of an evidence based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive mandates (legislative or regulatory), the service may be identified by adding 33 to the procedure. For separately reported services specifically identified as preventive, the modifier should not be used.”


1. What is modifier 33?


Modifiers are the exceptions to the rule and they are “the additional information”. They are appended directly to the applicable CPT code. In this webinar we introduced the Modifier 33, but there are others. See the following resources for a list and definition of other modifiers: http://www.codingahead.com/2009/08/list-of-modifiers.html.


Modifier 33 is applied to indicate that a preventive or screening service has taken place. The modifier may waive a patient's co-pay, deductible, and co-insurance so that there is no cost sharing. This modifier is only used on claims for commercial payers (BCBS, CIGNA, TUFTS etc). The modifier 33 does not have to be appended to those services that are inherently preventive (annual exams and preventive counseling).


Below is a list of services that the modifier 33 could be applied to. The modifier (as in all modifiers) is appended directly to the applicable CPT code.


*Services rated A or B by the U.S. Preventive Services Task Force (USPSTF);


*Immunizations for routine use in children, adolescents, and adults as recommended by the Advisory Committee on Immunization Practices of the U.S.

Department of Health and Human Services;


*Preventive care and screenings for children as recommended by the Bright Futures program of the American Academy of Pediatrics and the newborn screening recommendations of the American College of Medical Genetics as supported by the Health Resources and Services Administration (HRSA); and


*Preventive care and screenings provided for women (not included in the task force recommendations) in the comprehensive guidelines supported by the

HRSA.


Example: High-risk (for STI) patient presents to the clinic for screening but has some complaints as well. The primary reason service is screening. You bill a 99213 (append the 33 modifier) and the Z codes utilized might be Z11.3 (screening for STIs) and Z72.51 (high-risk heterosexaul behavior). 



 Anesthesia Furnished in Conjunction with Colonoscopy


Section 4104 of the Affordable Care Act defined the term “preventive services” to include “colorectal cancer screening tests” and as a result it waives any coinsurance that would otherwise apply under Section 1833(a)(1) of the Act for screening colonoscopies. In addition, the Affordable Care Act amended Section 1833(b)(1) of the Act to waive the Part B deductible for screening colonoscopies. These provisions are effective for services furnished on or after January 1, 2011.


In the CY 2015 PFS Proposed Rule, CMS proposed to revise the definition of “colorectal cancer screening tests” to include anesthesia separately furnished in conjunction with screening colonoscopies; and in the CY 2015 PFS Final Rule with comment period, CMS finalized this proposal. The definition of “colorectal cancer screening tests” includes anesthesia separately furnished in conjunction with screening colonoscopies in the Medicare regulations at Section 410.37(a)(1)(iii). As a result, beneficiary coinsurance and deductible does not apply to anesthesia services associated with screening colonoscopies.


As a result, effective for claims with dates of service on or after January 1, 2015, anesthesia professionals who furnish a separately payable anesthesia service in conjunction with a screening colonoscopy (HCPCS code 00810 performed in conjunction with G0105 and G0121) shall include the following on the claim for the services that qualify for the waiver of coinsurance and deductible:


* Modifier 33 – Preventive Services: when the primary purpose of the service is the delivery of an evidence based service in accordance with a USPSTF A or B rating in

effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be identified by adding 33 to the

procedure. For separately reported services specifically identified as preventive, the modifier should not be used. 


In addition, deductible is not applied to claim lines with HCPCS 00810 services that are billed with the PT modifier for services on or after January 1, 2015. The deductible is also not applied when the PT modifier is appended to at least either one of the CPT codes within the surgical range of CPT codes (10000-69999) or HCPCS codes G6018-G6028 on the claim for services that were furnished on the same date of service as the procedure. But, MACs will apply deductible and coinsurance to claim lines for HCPCS 00810 services billed without modifier 33 or modifier PT.


When to use modifier 33: preventive service modifier


Modifier 33 was created in response to the preventive service requirements associated with the PPACA. When the primary purpose of the service is the delivery of an evidence-based service in accordance with a U.S. Preventive Services Task Force A or B rating in effect, and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be identified by appending modifier 33, preventive service, to the procedure code.


For services represented by codes which may be used for either diagnostic, therapeutic or preventive services, modifier 33 must be appended to that code on the claim when the service was used for the preventive indication.


• For example, CPT code 45378, colonoscopy, may be performed for the 50-year-old asymptomatic individual as a routine screening for colorectal cancer. In this case, the colonoscopy is performed for preventive screening and modifier 33 should be appended, in addition to a well-person diagnosis code, such as V76.51.

• However, a colonoscopy, using this same code, may be performed in response to symptoms which a person exhibits. In that case, this service represents diagnostic colonoscopy.  The diagnosis code would be one which would signify the symptoms exhibited and modifier 33 would not be appended. 


When a separately submitted service is inherently preventive, modifier 33 is not used.


• Routine immunizations recommended for persons living in the United States to prevent communicable diseases are inherently preventive. Therefore modifier 33 would not be appended to these codes.

• Preventive medicine services (office visit services) represented by codes 99381-99387, 99391-99397, 99401- 99404, and 99406-99412 are distinct from problem-oriented

evaluation and management office visit codes and are inherently preventive. Therefore, modifier 33 would not be utilized with these codes.

• The CPT code for screening mammography is inherently preventive and therefore modifier 33 would not be used.


Billing Guidelines


Modifiers 33 and PT are key components to submitting accurate preventive services claims; as such, it’s important to review and become familiar with the following billing guidance.

 

Modifier 33*The appropriate use of modifier 33 will help reduce claim adjustments related to preventive services and your corresponding refunds to members. Modifier 33 applies to commercial lines of business only.


*CPT modifier 33 is applicable to preventive services that do not have a unique code for such services (e.g., E&M codes such as, 99401 would not require modifier 33 as this code already indicates a preventive medicine service. However, code 99213 would require modifier 33 when the provider indicates that the service was preventive).


*If multiple preventive medicine services are provided on the same day, then the modifier is appended to the codes for each preventive service rendered on that day.


*Modifier 33 should be used when only preventive services were rendered on that date, not when combined with other non-preventive services.


*CPT codes not appended with modifier 33 will process under the member’s medical or preventive benefits, based on the diagnosis and CPT codes submitted.


*CPT codes identified as inherently preventive, (e.g., screening mammography) should not be appended with modifier 33.


*This modifier may be used to identify when a service was initiated as a preventive service, which then resulted in a conversion to a therapeutic service. The most notable example of this is screening colonoscopy (code 45378), which results in a polypectomy (code 45383).


Modifier PT *Modifier PT applies to Medicare products only (Medicare Advantage and Medicare Supplemental). To determine the appropriate use of modifier PT, it’s important to know why the member is presenting for treatment.


Modifier PT indicates that a colorectal cancer screening test was converted to a diagnostic test or other procedure (impacts colonoscopy and sigmoidoscopy codes). The appropriate use of modifier PT will help reduce claim adjustments related to colorectal screenings and your corresponding refunds to members.

Please see the following scenarios for guidance:


*Screening exam only: In a situation where a member presents for treatment solely for the purpose of a screening exam, without any signs or symptoms of a disease, then such a procedure should be considered a screening. The appropriate use of diagnosis codes and screening procedure codes is valuable in promoting appropriate adjudication of the claim. The use of the modifier PT in conjunction with a CPT procedure or HCPCS code that is defined as a screening based on that code’s description is not necessary.


*Treatment due to signs or symptoms to rule out or confirm a suspected diagnosis:


In the instance that a member presents for treatment due to signs or symptoms to rule out or confirm a suspected diagnosis, such an encounter should be considered a diagnostic exam, not a screening exam. In such a situation, the modifier PT should not be used and the sign or symptom should be used to explain the reason for the test. 


*Screening colorectal exam converted to a diagnostic service: In a circumstance where a member presents for a screening exam (without signs or symptoms), and an issue is encountered during that preventive exam, then such a circumstance would warrant the use of the PT modifier. The procedure and diagnosis codes that would typically be used in such an instance may not clearly demonstrate that the service began as a screening procedure, but had to be converted to a diagnostic procedure due to a pathologic finding (e.g., polyp, tumor, bleeding) encountered during that preventive exam. The use of the PT modifier in the instance of a screening colorectal exam being converted to a diagnostic service would clarify that despite the end result the service began as a screening service.



Reimbursement Information: 


Modifiers may be appended to CPT/ HCPCS code(s) if the service or procedure is clinically supported for use of modifiers. A claim should be submitted with the correct modifier-to-procedure code combination. Modifiers should not be appended to a CPT/HCPCS code(s) to circumvent a National Correct Coding Initiative (NCCI)

Procedure to Procedure (PTP) edit if the service or procedure is not clinically supported for the use of a modifier. Claim submissions may be denied if a claim contains an inappropriate modifier-to-procedure code combination. In this case, a corrected claim submission with the correct modifier-to-procedure code combination will be necessary to be considered for reimbursement. Medical records or other documentation should accompany the claim to ensure appropriateness of claim reimbursement.


If billing with more than one modifier, list the modifier that will impact reimbursement first.

The modifiers listed below may appear in some of the material on the applicable state plan’s provider website. The following is not an all-inclusive list and modifiers may be added or removed with appropriate notice.


MODIFIER DESCRIPTION WHEN TO APPEND A MODIFIER

33 Preventive services Append to codes represented for evidence-based services in accordance with a US Preventive Services Task Force A and B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory).

• Modifier 33 should be used for CPT codes representing preventive care services. 

CPT code S5100, S5110,S5102, S5105, S5115 - Day and home care services

Procedure code and Description


 S5100 Day care services, adult; per 15 minutes

S5110 Home care training, family; per 15 minutes

S5102    Day care services, adult; per diem

S5105    Day care services, center-based; services not included in program fee per diem

S5115 Home care training, nonfamily; per 15 minutes 


DEFINITIONS


Please check the definitions within the member benefit plan document that supersede the definitions below.


Custodial Care: Services that are any of the following non-Skilled Care services:


• Non-health-related services, such as help with daily living activities. Examples include eating, dressing, bathing, transferring and ambulating.


• Health-related services that can safely and effectively be performed by trained non-medical personnel and are provided for the primary purpose of meeting the personal needs of the patient or maintaining a level of function as opposed to improving that function to an extent that might allow for a more independent existence.


Place of Residence: Wherever the member makes his/her home. This may include his/her dwelling, an apartment, a relative's home, home for the aged, or a Custodial Care facility. Skilled Care: Skilled nursing, skilled teaching, skilled habilitation, and skilled rehabilitation services when all of the following are true:


• Must be delivered or supervised by licensed technical or professional medical personnel in order to obtain the specified medical outcome, and provide for the safety of the patient

• Ordered by a Physician

• Not delivered for the purpose of helping with activities of daily living, including dressing, feeding, bathing or transferring from a bed to a chair

• Requires clinical training in order to be delivered safely and effectively

• Not Custodial Care, which can safely and effectively be performed by trained non-medical personnel



Indications for Coverage


• Skilled Care in the member’s Place of Residence. Skilled Care includes:

o Skilled nursing

o Skilled teaching

o Skilled rehabilitation (physical therapy, occupational therapy and speech therapy)

• For Skilled Care to be covered in the member’s Place of Residence, the following criteria must be met:

o A plan of care must be established and periodically reviewed and updated by the treating practitioner or specialist

o Be ordered and directed by a licensed practitioner or specialist (M.D., D.O., P.A. or N.P)

o It must not be Custodial Care

o The care must be delivered or supervised by a licensed nurse, technical or professional medical personnel in order to obtain a specified medical outcome

o The care requires clinical training in order to be delivered safely and effectively

o The member’s condition must be documented to be such that they cannot receive the Skilled Care in a setting other than the member’s Place of Residence



OVERVIEW

Adult medical day care services in community-based facilities provide structured, individualized programs to meet the physical and/or cognitive health needs of adults with disabilities, living at home, who are unable to care for themselves for long periods of time. Adult day programs provide a variety of care management, including nursing, nutritional, therapeutic, personal care, educational and family support services in a protective, medically supervised setting during daytime hours. Members return to their home and caregiver(s) at the end of the day. Nursing, functional and social supports are tailored to meet the unique needs of program participants and their family caregivers. Members need to meet, at a minimum, a preventive level of care, as determined by the RI Executive Office of Health and Human Services (EOHHS) Office of Long Term Service Supports, in order to receive adult day care services:


• Member has a chronic illness or disability that requires, at a minimum: 


- Supervision with 2 or more activities of daily living (ADLs) such as, bathing, eating, dressing, toileting, and ambulation/transfers

OR

- Extensive or greater assistance with at least 3 instrumental activities of daily living (IADLs) such as meal preparation, laundry, shopping, and cleaning.

• There must be no other person or agency available to perform these services.

• The criteria will be based on (1) a physician or other licensed practitioner’s assessment and (2) a DHS caseworker or EOHHS nurse’s assessment.

Providers will need to check Member Eligibility on the Healthcare Portal to determine if the recipient is entitled to Adult Day Care Services. If the recipient is enrolled in one of the following waivers then the person qualifies to receive the service: Preventive, Core Community, DEA Community, Habilitation Community, Shared Living and Intellectual Disabilities


CLINICAL COVERAGE CRITERIA


1. The Member must have a medical or mental dysfunction that involves one or more physiological systems and indicates a need for nursing care, supervision, therapeutic services, support services, and/or socialization.


2. The Member must require services in a structured adult day health setting.


3. The Member must have personal physician that can attest to the Member’s need.


4. Adult day health service provider must complete a health assessment for admission; establish an oversight and monitoring process for the program that involves a licensed nurse; and provide standard and ad hoc reporting on this project.


There are two levels of adult day care, basic and enhanced.


– Basic is the provision of services by the ADC provider of an organized program of supervision, health promotion, and health prevention services that include the availability of nursing services and health oversight, nutritional dietary services, counseling, therapeutic activities and case management.


Enhanced is the provision of services by the ADC provider when the participant meets at least one of the five requirements:


• Daily assistance, on site in center, with at least two activities of daily living


• Daily assistance, on site in center, with at least one skilled service, by registered professional nurse (RN) or licensed practical nurse (LPN)


• Daily assistance, on site in center, with at least one ADL which requires a two-person assist to complete the ADL


• Daily assistance, on site in center, with at least 3 ADL’s when supervision and cueing are needed to complete the ADL’s identified


• An individual who has been diagnosed with Alzheimer’s disease or other related dementia, or mental health diagnosis, as determined by a physician, and, requires regular staff interventions due to safety concerns related to elopement risk or other behaviors and inappropriate behaviors that adversely impact themselves or others. Such behaviors and interventions must be documented in the participant’s care plan and in the required progress notes.


Definitions:


Activities of daily living (ADL’s) are defined as basic tasks of everyday life, such as eating, bathing, dressing, toileting, and transferring. Instrumental activities of daily living (IADL’s) are defined as a range of activities that are more complex than those needed for ADLs, including meal preparation, shopping, housework, using the telephone, and taking medications.


*Daily assistance= every day of attendance


Exclusions:


• Individuals who reside in a facility-based setting

• Days or portion of day(s) not attended by Member

• If admission of the individual to adult day health services would result in the individual receiving duplicative or substantially identical services as those provided by any other Medicaid funded service that the individual has chosen, then the individual will not be eligible for adult day health services. Ambulatory care settings include but are not limited to, the home, personal care attendant services, a physician’s office, a hospital outpatient department, a partial care/partial

hospitalization program, and an adult day training program.


• An adult who has partial care/partial hospitalization program services on a particular day is not eligible for adult day health services on the same day.

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