Saturday, March 9, 2019

cpt 43843, 43845, 43846 - 43888 - Bariatric surgery

CPT code and Descriptions


 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty
43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption
43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)
43886 Gastric restrictive procedure, open; revision of subcutaneous port component only
43887 Gastric restrictive procedure, open; removal of subcutaneous port component only
43888 Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only


Bariatric Surgery

Introduction


Bariatrics is the branch of medicine dealing with the causes and treatment of obesity. Clinically severe obesity (also known as morbid obesity) is when a person is excessively overweight. Obesity itself is a health hazard as it impacts the heart, lungs, muscles, and bones of the body. In addition, obesity is a known risk factor to develop type 2 diabetes, heart disease and high blood pressure. Many individuals are able to lose weight by changing their diet and increasing their exercise. The challenge for most people is keeping off the weight they have lost. For some people surgery may be needed. Bariatric surgery is often referred to as weight loss surgery or obesity surgery. Surgical approaches to support long-term weight loss have been developed over the past 20 years. For some individuals the surgery works very well, although even after surgery people may need to significantly change their eating habits. Surgery is not without risk, however. There are several different types of weight loss surgery that are done on the stomach, intestine or both. They generally fall into two main categories: surgeries that restrict the amount of food that may be eaten, and surgeries that restrict the body’s ability to absorb calories and nutrients. Not all plans cover obesity surgery. When plans have a benefit for obesity surgery, then this policy describes what information is needed by the health plan to determine if the surgery may be covered.


Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended fo providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Indication Coverage Criteria  Contract limitations Some health plan contracts do not have benefits to cover surgical treatment of morbid obesity, complications, or after effects associated with weight loss surgery. Refer to member contract language for benefit determination on weight loss surgery.

Patient selection criteria for adults (Must meet all 3 criteria) Bariatric (weight loss) surgery in an adult may be considered medically necessary when ALL of the following criteria are met:

* A body mass index (BMI) greater than 40 kg/m2 OR
* A BMI greater than 35 kg/m2 with at least ONE of the following conditions:
o Established Coronary Heart Disease, such as:
* History of angina pectoris (stable or unstable)
* History of angioplasty
* History of coronary artery surgery
* History of myocardial infarction
o Other Atherosclerotic Disease, such as:
* Abdominal aortic aneurysm
* Hypertension that is uncontrolled or resistant to treatment (medically refractory) with a blood pressure (BP) greater than 140/90 despite optimal medical management. Attempted medical management must have included at least 2 medications of different classes
* Peripheral arterial disease
* Symptomatic carotid artery disease
o Type 2 Diabetes uncontrolled by pharmacotherapy
o Obstructive sleep apnea as documented by a sleep study


Indication Coverage Criteria (polysomnography) (see Related Policies). AND

* Participation in a physician administered weight reductionprogram lasting at least six continuous months within the two year period before surgery is considered. o Evidence of active participation documented in the medical record includes:

* Weight

* Current dietary program (MediFast, OptiFast)

* Physical activity (eg, exercise/work-out program) OR

* Documentation of participation in a structured weight reduction program such as as Weight Watchers or Jenny Craig is an acceptable alternative if done in conjuction with physician supervision AND

* Psychological evaluation and clearance by a licensed mental health provider to rule out psychological disorders, inability to provide informed consent, or inability to comply with pre- and post-surgical requirements

Note: A physician’s summary letter alone is not sufficient documentation. Patient selection criteria for adolescents less than 18 years of age

Bariatric (weight loss) surgery in adolescents may be considered medically necessary when ALL of the following criteria are met:

* The health plan contract allows bariatric surgery for those younger than 18 years of age AND

* The adolescent meets the same patient selection criteria as an adult AND

* The facility has experienced staff to support adolescents including psychosocial and informed consent issues for bariatric surgery

Indication Coverage Criteria

Refer to member contract language for benefit determination on treatment of obesity for adolescents. Covered bariatric (weight loss) surgeries

The following bariatric (weight loss) surgery procedures may be considered medically necessary when criteria are met:
* Adjustable gastric banding–laparoscopic
* Biliopancreatic bypass (ie, the Scopinaro procedure) with duodenal switch–open or laparoscopic
* Gastric bypass using a Roux-en-Y anastomosis–open or laparoscopic
* Sleeve gastrectomy Surgeon and facility requirements
Bariatric (weight loss) surgery should be performed:
* By a surgeon with specialized training and experience in the bariatric surgery procedure used AND
* In an institution (facility or hospital) that includes a comprehensive bariatric surgery program AND
* Any device used for bariatric surgery must be FDA approved for that purpose and used according to the labeled indications Revision bariatric surgery to correct complications

Revision bariatric (weight loss) surgery (such as replacement and/or removal of an adjustable gastric band, surgical repair or reversal, or conversion to another covered bariatric surgical procedure) may be considered medically necessary to correct complications from the primary bariatric procedure including, but not limited to:
* Band erosion, slippage, leakage, herniation or intractable nausea/vomiting that cannot be corrected with manipulation or adjustment
* Hypoglycemia or malnutrition related to non-absorption
* Obstruction
* Staple-line failure (eg, Gastrogastric fistula)
* Stricture
* Ulceration
* Weight loss of 20% or more below ideal body weight
* Coverage for bariatric surgery is available under the individual’s


Indication Coverage Criteria current health benefit plan Reoperation bariatric  surgery for inadequateweight loss

In the absence of a technical failure or major complication, individuals with weight loss failure (not described above) must meet the initial medical necessity criteria for bariatric surgery Cholecystectomy Routine cholecystectomy (gallbladder removal) may be considered medically necessary when performed with bariatric surgery.

Hiatal hernia repair Repair of a hiatal hernia during bariatric surgery may be considered medically necessary for a preoperative diagnosis of hiatal hernia with clinical indications for surgical repair. Repair of a hiatal hernia performed at the time of bariatric surgery in the absence of preoperative clinical indications for surgical repairis considered not medically necessary Routine liver biopsy Routine liver biopsy during obesity surgery is considered not medically necessary in the absence of preoperative signs or symptoms of liver disease.(eg, elevated liver enzymes, enlarged liver)

Bariatric surgery for a BMI less than 35 kg/m2

Bariatric (weight loss) surgery is considered not medically necessary for patients with a BMI less than 35 kg/m2.

Bariatric surgery to treat conditions other than morbid obesity

Bariatric surgery is considered investigational for the treatment of any condition other than morbid obesity, including, but not limited to diabetes, gastroesophageal reflux disease (GERD), or gastroparesis

Non-covered bariatric surgeries/procedures

Vertical banded gastroplasty (stomach stapling) is considered not medically necessary as a treatment for obesity due to too many long-term complications.

The following weight loss (bariatric) surgery procedures are considered investigational for the treatment of morbid obesity:
* Biliopancreatic bypass without duodenal switch
* Gastric bypass using a Billroth II type of anastomosis (minigastric bypass)
* Laparoscopic gastric plication

Indication Coverage Criteria

* Long-limb gastric bypass procedure (ie, >150 cm)
* Single anastomosis duodenoileal bypass with sleeve gastrectomy
* Two-stage bariatric surgery procedures (eg, sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time)
* Vagus nerve blocking (eg, the VBLOC device or Maestro®) (See related medical policy 7.01.150)
* Endoscopic procedures as a primary bariatric procedure or as a revision procedure including but not limited to:
o Insertion of the StomaphyX™ device
o Insertion of a gastric balloon (eg, Orbera®)
o Endoscopic gastroplasty
o Use of an endoscopically placed duodenal-jejunal sleeve
o Aspiration therapy device (eg, AspireAssist®)

Documentation Requirements
The medical records submitted for review should document that medical necessity criteria are met. The record should include clinical documentation of ALL THREE (3) criteria:

1. A body mass index (BMI) greater than 40 kg/m2, or BMI greater than 35 kg/m2 with at least ONE (1) of the following conditions:
o Established coronary heart disease
o Other atherosclerotic disease
o Type 2 diabetes uncontrolled by medications
o Obstructive sleep apnea as documented by a sleep study
2. Completion of a physician administered weight-loss program that:
o Lasted for at least six (6) months in a row
o Took place within two (2) years before the proposed weight loss surgery
o Demonstrates in the medical record that the member actively took part in the program, as well as include member’s weight, the current dietary program (MediFast, OptiFast) and banded gastroplasty



Body Mass Index Calculation Morbid obesity, also known as clinically severe obesity, is measured using the body mass index (BMI). Severe obesity is weight-based and is defined as a BMI greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with obesity-associated health conditions. BMI is calculated by dividing a patient’s weight (in kilograms) by height (in meters) squared.
* To convert pounds to kilograms, multiply pounds by 0.45
* To convert inches to meters multiply inches by 0.0254
* Click here for BMI calculation.

Evidence Review Description

Bariatric surgery is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous surgical techniques available. While these techniques have different mechanisms of action,the result is a smaller gastric pouch that leads to restricted eating. However, these surgeries may lead to malabsorption of nutrients or eventually to metabolic changes .

Background

Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, prostate; for women: breast, uterine, ovarian), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as “those patients with a BMI of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes.”1 Resolution (cure) or improvement of type 2 diabetes (T2D) after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to the treatment of T2D.

The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional antidiabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, eg, glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. GIP acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. PYY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

Types of Bariatric Surgery Procedures

The following summarizes the most common types of bariatric surgery procedures.

Open Gastric Bypass

The original gastric bypass surgeries were based on the observation that postgastrectomy patients tended to lose weight. The current procedure involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (ie, a gastrojejunal anastomosis). Thus, the flow of food bypasses the duodenum and proximal small bowel. The procedure may also be associated with an unpleasant “dumping syndrome,” in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting. The dumping syndrome may further reduce intake, particularly in “sweets eaters.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications than with other gastric restrictive procedures, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia, all of which can be corrected by oral supplementation. Another concern is the ability to evaluate the “blind” bypassed portion of the stomach. Gastric bypass may be performed with either an open or laparoscopic technique.


Note: In 2005, the CPT code 43846 was revised to indicate that the short limb must be 150 cm or less, compared with the previous 100 cm. This change reflects the common practice in which the alimentary (ie, jejunal limb) of a gastric bypass has been lengthened to 150 cm. This length also serves to distinguish a standard gastric bypass with a very long, or very, very long gastric bypass, as discussed further here.

Laparoscopic Gastric Bypass

CPT code 43644 was introduced in 2005 and described the same procedure as open gastric bypass (CPT code 43846), but performed laparoscopically.

Adjustable Gastric Banding


Adjustable gastric banding (CPT code 43770) involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the gastric band; therefore, the rate-limiting stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions, if necessary, are relatively simple.

Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the Food and Drug Administration (FDA) for marketing in the United States. The first to receive FDA approval was the LAP-BAND (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND® system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame).

It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."


In 2011, FDA-labelled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m2 with at least 1 obesity-related comorbid condition. The second adjustable gastric banding device approved by FDA through the premarket approval process is the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are:

“Th[e REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

Sleeve Gastrectomy

A sleeve gastrectomy (CPT code 43775) is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion [BPD] with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum and avoiding the dumping syndrome (overly rapid transport of food through the stomach into intestines) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a 2-stage procedure for very high risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and, thus, reduce the risk of a subsequent more extensive malabsorptive procedure (eg, BPD).

Biliopancreatic Bypass Diversion

The BPD procedure (also known as the Scopinaro procedure; CPT code 43847) developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

a. A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
b. A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.
c. A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.
d. A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, ie, creating selective malabsorption. The length of the common segment will influence the degree of malabsorption.
e. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to BPD, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, several case reports have noted liver failure resulting in death or liver transplant.

BPD With Duodenal Switch

CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is a variant of the BPD previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the BPD, to create the alimentary limb. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum. The sleeve gastrectomy also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the BPD, ie, producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

Vertical-Banded Gastroplasty


Vertical-banded gastroplasty (VBG; CPT code 43842) was formerly one of the most common gastric restrictive procedures performed in the United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. In order to create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of the stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include  esophageal reflux, dilation, or obstruction of the stoma, with the latter 2 requiring reoperation. Dilation of the stoma is a common reason for weight regain. VBG may be performed using an open or laparoscopic approach.

Long-Limb Gastric Bypass (ie, >150 cm)

Variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures (CPT code 43847), which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways (eg, resection or stapling along the  horizontal or vertical axis). Unlike the traditional gastric bypass, which is a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb (<150 and="" apply="" br="" bypass.="" cm="" gastric="" gastroenterostomy="" long-limb="" not="" roux-en-y="" thus="" to="" would="">


Laparoscopic Malabsorptive Procedure CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the code does not specifically describe any specific malabsorptive procedure.

Weight Loss Outcomes

There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. EBW is defined as actual weight minus “ideal weight” and “ideal weight” is based on 1983 Metropolitan Life Insurance height-weight tables for medium frame.

These 2 reporting methods are generally preferred over the absolute amount of weight loss, because they reflect the ultimate goal of surgery: to reduce weight to a range that minimizes obesity-related morbidity. Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals. There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. Table 1 summarizes the variations in reporting weight loss outcomes.


Durability of Weight Loss Weight change (ie, gain or loss) at yearly intervals is often reported. Weight loss at 1 year is considered the minimum length of time for evaluating these procedures; weight loss at 3 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery. Short-Term Complications (Operative and Perioperative Complications <30 br="" days="">
In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative

complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary
complications (eg, pneumonia, myocardial infarction).
Reoperation Rate
Reoperation may be required to either “take down” or revise the original procedure.
Reoperation may be particularly common in VBG due to pouch dilation.


Long-Term Complications (Metabolic Adverse Events, Nutritional Deficiencies)

Metabolic adverse events are of particular concern in malabsorptive procedures. Other longterm complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric-banding surgeries. Improved Health Outcomes in Terms of Weight-Related Comorbidities Aside from psychosocial concerns, which may be considerable, one motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (ie, increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported.

Monday, February 11, 2019

CPT 0075T, 0076T - Endovascular Therapies for Extracranial Vertebral Artery Disease

Coding Code Description CPT

0075T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel

0076T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure)


Endovascular Therapies for Extracranial Vertebral Artery Disease


Introduction


The vertebral arteries travel along the spine, up the back of the neck, and enter the brain. When one of these arteries is narrowed, blocked, or there is a bulge before it enters the brain, it’s known as extracranial vertebral artery disease. (Extracranial means outside the skull.) Treatment usually involves medication or surgery. Other techniques that are done inside the blood vessels are being studied. These techniques are known as endovascular therapies. An example of an endovascular therapy is placing a tiny tube inside a blocked artery to allow blood to flow through it. Endovascular therapy for extracranial vertebral artery disease is investigational. These techniques are still being studied to see if they are as effective as standard treatments.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

Service Investigational


Endovascular therapy Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery disease.

Note: The extracranial vertebral artery is considered to be segments V1-V3 of the vertebral artery from its origin at the subclavian artery until it crosses the dura mater.



Related Information N/A

Evidence Review

Description

Vertebral artery diseases, including atherosclerotic stenosis, dissections, and aneurysms, can lead to ischemia of the posterior cerebral circulation. Conventional management of extracranial vertebral artery diseases may include medical therapy (eg, antiplatelet or anticoagulant medications), medications to reduce atherosclerotic disease risk (eg, statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.

Background

Vertebrobasilar Circulation Ischemia


Ischemia of the vertebrobasilar or posterior circulation accounts for about 20% of all strokes. Posterior circulation strokes may arise from occlusion of the innominate and subclavian arteries, the extracranial vertebral arteries, or the intracranial vertebral, basilar, or posterior cerebral arteries. Compared with carotid artery disease, relatively little is known about the true prevalence of specific causes of posterior circulation strokes, particularly the prevalence of vertebral artery disease. A report from a stroke registry, Gulli et al (2013), estimated that in 9% of cases posterior circulation strokes are due to stenosis of the proximal vertebral artery.1 Patients who experience strokes or transient ischemic attacks of the vertebrobasilar circulation face a 25% to 35% risk of stroke within the subsequent 5 years. In particular, the presence of vertebral artery stenosis increases the 90-day risk of recurrent stroke by about 4-fold.

Relevant Clinical Anatomy and Pathophysiology

Large artery disease of the posterior circulation may be due to atherosclerosis (stenosis), embolism, dissection, or aneurysms. In about a third of cases, posterior circulation strokes are due to stenosis of the extracranial vertebral arteries or the intracranial vertebral, basilar, and posterior cerebral arteries. The proximal portion of the vertebral artery in the neck is the most common location of atherosclerotic stenosis in the posterior circulation. Dissection of the extracranial or intracranial vertebral arteries may also cause posterior circulation ischemia. By contrast, posterior cerebral artery ischemic events are more likely to be secondary to embolism from more proximal vessels.

The vertebral artery is divided into 4 segments, V1-V4, of which segments V1-V3 are extracranial. V1 originates at the subclavian artery and extends to the C5 or C6 vertebrae; V2


crosses the bony canal of the transverse foramina from C2 to C5; V3 starts as the artery exits the transverse foramina at C2 and ends as the vessel crosses the dura matter and becomes an intracranial vessel. The most proximal segment (V1) is the most common location for atherosclerotic occlusive disease to occur, while arterial dissections are most likely to involve the extracranial vertebral artery just before the vessel crosses the dura mater. Compared with the carotid circulation, the vertebral artery system is more likely to be associated with anatomic variants, including a unilateral artery.

Atherosclerotic disease of the vertebral artery is associated with conventional risk factors for cerebrovascular disease. However, risk factors and the underlying pathophysiology of vertebral artery dissection and aneurysms differ. Extracranial vertebral artery aneurysms and dissections are most often secondary to trauma, particularly those with excessive rotation, distraction, or flexion/extension, or iatrogenic injury, such as during cervical spine surgeries. Spontaneous vertebral artery dissections are rare, and in many cases are associated with connective tissue disorders including Ehlers-Danlos syndrome type IV, Marfan syndrome, autosomal-dominant polycystic kidney disease, and osteogenesis imperfecta type I.2

Management of Extracranial Vertebral Artery Disease
The optimal management of occlusive extracranial vertebral artery disease is not well defined. Medical treatment with antiplatelet or anticoagulant medications is a mainstay of therapy to reduce stroke risk. Medical therapy also typically involves risk reduction for classical cardiovascular risk factors. However, no randomized trials have compared specific antiplatelet or anticoagulant regimens.

Surgical revascularization may be used for vertebral artery atherosclerotic disease, but open surgical repair is considered technically challenging due to poor access to the vessel origin.

Surgical repair may involve vertebral endarterectomy, bypass grafting, or transposition of the vertebral artery, usually to the common or internal carotid artery. Moderately sized single-center case series of surgical vertebral artery repair from 2012 and 2013 have reported overall survival rates of 91% and 77% at 3 and 6 years postoperatively, respectively, and arterial patency rates of 80% after 1 year of follow-up.3,4 Surgical revascularization may be used when symptomatic vertebral artery stenosis is not responsive to medical therapy, particularly when bilateral vertebral artery stenosis is present or when unilateral stenosis is present in the presence of an occluded or hypoplastic contralateral vertebral artery. Surgical revascularization may also be considered in patients with concomitant symptomatic carotid and vertebral disease who do not have relief of vertebrobasilar ischemia after carotid revascularization.


The management of extracranial vertebral artery aneurysms or dissections is controversial due to uncertainty about the risk of thromboembolic events associated with aneurysms and dissections. Antiplatelet therapy is typically used; surgical repair, which may include vertebral bypass, external carotid autograft, and vertebral artery transposition to the internal carotid artery, or endovascular treatment with stent placement or coil embolization, may also be used. Given the technical difficulties related to surgically accessing the extracranial vertebral artery, endovascular therapies have been investigated for extracranial vertebral artery disease. Endovascular therapy may consist of percutaneous transluminal angioplasty, with or without stent implantation.

Friday, January 4, 2019

CPT 33361, 33362, 33363- 33369 - Transcatheter Aortic Valve Implantation for Aortic Stenosis

Coding Code Description CPT

33361 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach

33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy)

33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy)

33367 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure)

33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure)

33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure)


Transcatheter Aortic Valve Implantation for Aortic Stenosis

Introduction


The aortic valve is a valve that separates the main pumping chamber of the heart (the left ventricle) from the large artery that takes oxygen rich blood away from the heart and out to the body (the aorta). If the valve doesn’t completely open, it is called aortic stenosis. Aortic stenosis decreases the amount of oxygenated blood getting out to the body. Open surgery is one method of replacing a damaged aortic valve. A newer procedure — known as transcatheter aortic valve replacement or transcatheter aortic valve implantation — has been developed. It allows a replacement valve to be threaded through an artery and into the heart without open heart surgery. A catheter (a long thin, tube) is threaded through an artery, either in the leg or in the chest, and into the heart. The replacement valve is then lodged into the defective aortic valve. The new valve is then expanded, pushing aside parts of the old valve. This policy describes when transcatheter aortic valve replacement may be considered medically necessary. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Procedure Medical Necessity Transcatheter aortic valve replacement

Transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)*approved transcatheter heart valve system, when performed via an approach consistent with the device’s FDA-approved labeling, may be considered medically necessary as a treatment for native valve aortic stenosis when ALL of the following criteria are met:
* Severe aortic stenosis (see the Definition of Terms section) with a calcified aortic annulus is present AND
* New York Heart Association (NYHA) heart failure class II, III or IV symptoms AND
* Left ventricular ejection fraction greater than 20% AND
* Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high or intermediate risk for open surgery (see the

Definition of Terms section)

Transcatheter aortic valve replacement with an FDA approved transcatheter heart valve system for repair of a degenerated bioprosthetic valve may be considered medically necessary

when ALL of the following criteria are met:
* Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve AND
* NYHA heart failure class II, III or IV symptoms AND
* Left ventricular ejection fraction greater than 20% AND
* Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high risk for open surgery (see the Definition of


Medical Necessity Terms section)

Transcatheter aortic valve replacement is considered investigational for all other indications and when criteria are not met.





Related Information Definition of Terms

Extreme risk or inoperable for open heart surgery: FDA definition of extreme risk or inoperable for open surgery:

* Predicted risk of operative mortality and/or serious irreversible morbidity 50% or higher for open surgery High Risk for open heart surgery: FDA definition of high risk for open surgery:
* Society of Thoracic Surgeons predicted operative risk score of 8% or higher; or
* Judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery Intermediate risk: FDA definition of intermediate risk is:
* Society of Thoracic Surgeons predicted operative risk score of 3% to 7%. Severe aortic stenosis: For the use of the Sapien or CoreValve devices, severe aortic stenosis is defined by the presence of one or more of the following criteria:
* An aortic valve area of less than or equal to 1 cm2
* An aortic valve area index of less than or equal to 0.6 cm2/m2
* A mean aortic valve gradient greater than or equal to 40 mm Hg
* A peak aortic-jet velocity greater than or equal to 4.0 m/s

Description

Transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement) is a potential treatment for patients with severe aortic stenosis. Many patients with aortic stenosis are elderly and/or have multiple medical comorbidities, thus indicating a high, often prohibitive, risk for surgery. This procedure is being evaluated as an alternative to open surgery, or surgical aortic valve replacement (SAVR), for high-risk patients with aortic stenosis and as an alternative to nonsurgical therapy for patients with a prohibitive risk for surgery.

Background

Aortic Stenosis


Aortic stenosis is defined as narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Progressive calcification of the aortic valve is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries.1 Congenital abnormalities of the aortic valve, most commonly a bicuspid valve, increase the risk for aortic stenosis, but aortic stenosis can also occur in a normal aortic valve. Risk factors for calcification of a congenitally normal valve mirror those for atherosclerotic vascular disease, including advanced age, male gender, smoking, hypertension, and hyperlipidemia.1 Thus, the pathogenesis of calcific aortic stenosis is thought to be similar to that of atherosclerosis, ie, deposition of atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification.

The natural history of aortic stenosis involves a long asymptomatic period, with slowly progressive narrowing of the valve until the stenosis reaches the severe stage. At this time, symptoms of dyspnea, chest pain, and/or dizziness and syncope often occur and the disorder  progresses rapidly. Treatment of aortic stenosis is primarily surgical, involving replacement of the diseased valve with a bio-prosthetic or mechanical valve by open heart surgery.

Disease Burden Aortic stenosis is a relatively common disorder in elderly patients and is the most common acquired valve disorder in the UnitedStates. Approximately 2% to 4% of people older than 65 years of age have evidence of significant aortic stenosis,1 increasing up to 8% of people by age 85 years.2 In the Helsinki Aging Study (1993), a population-based study of 501 patients ages 75 to 86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%.3 In the United States, more than 50,000 aortic valve replacements are performed annually due to severe aortic stenosis.

Aortic stenosis does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it becomes severe, there is an untreated mortality rate of approximately 50% within 2 years.4 Open surgical repair is an effective treatment for reversing aortic stenosis, and artificial valves have demonstrated good durability for periods of up to 20 years.4 However, these benefits are accompanied by a perioperative mortality of approximately 3% to 4% and substantial morbidity,4 both of which increase with advancing age.

Unmet Needs
Many patients with severe, symptomatic aortic stenosis are poor operative candidates. Approximately 30% of patients presenting with severe aortic stenosis do not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities.5 For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes.6 Balloon valvuloplasty can improve symptoms and increase flow across the stenotic valve but is associated with high rates of complications such as stroke, myocardial infarction (MI), and aortic regurgitation. Also, restenosis can occur rapidly, and there is no improvement in mortality. As a result, there is a large unmet need for less invasive treatments for aortic stenosis in patients who are at increased risk for open surgery.

Treatment

Transcatheter aortic valve implantation (TAVI) has been developed in response to this unmet needand was originally intended as an alternative for patients for whom surgery was not an option due toprohibitive surgical risk or for patients at high risk for open surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also  be done through the subclavian artery approach and transapically using mediastinoscopy. Balloon valvuloplasty is first performed to open up the stenotic area. This is followed by passageof a bioprosthetic artificial valve across the native aortic valve. The valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic valve annulus. The procedure is performed on the beating heart without the need for cardiopulmonary bypass.

Summary of Evidence
For individuals who have severe symptomatic aortic stenosis who are at prohibitive risk for open surgery who receive transcatheter aortic valve implantation (TAVI), the evidence includes a randomized controlled trial (RCT) comparing TAVI with medical management in individuals at prohibitive risk of surgery, a single-arm prospective trial, multiple case series, and multiple systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are not surgical candidates due to excessive surgical risk, the PARTNER B trial reported on results for patients treated with TAVI by the transfemoral approach compared with continued medical care with or without balloon valvuloplasty. There was a large decrease in mortality for the TAVI patients at 1 year compared with medical care. This trial also reported improvements in other relevant clinical outcomes for the TAVI group. There was an increased risk of stroke and vascular complications in the TAVI group. Despite these concerns, the overall balance of benefits and risks from this trial indicate that health outcomes are improved. For patients who are not surgical candidates, no randomized trials have compared the self-expandable valve with best medical therapy. However, results from the single-arm CoreValve Extreme Risk Pivotal Trial met trialists’ pre-specified objective performance goal. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at high risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals at high risk for surgery, multiple nonrandomized comparative studies, and systematic reviews of these studies. Relevant outcomes are overall survival, symptoms, morbid events, and  treatment-related mortality and morbidity.


For patients who are high risk for open surgery and are surgical candidates, the PARTNER A trial reported noninferiority for survival at 1 year for the balloon-expandable valve compared with open surgery. In this trial, TAVI patients also had higher risks for stroke and vascular complications. Nonrandomized comparative studies of TAVI versus open surgery in high-risk patients have reported no major differences in rates of mortality or stroke between the 2 procedures. Since publication of the PARTNER A trial, the CoreValve High Risk Trial demonstrated noninferiority for survival at 1 year and 2 years for the self-expanding prosthesis. This trial reported no significant differences in stroke rates between groups. In an RCT directly comparing the self-expandable with the balloon-expandable valve among surgically high-risk patients, the devices had similar 30-day mortality outcomes, although the self-expandable valve was associated with higher rates of residual aortic regurgitation and requirement for a new permanent pacemaker. Evidence from RCT and nonrandomized studies has suggested that TAVI with a self-expanding device is associated wit higher rates for permanent pacemakers postprocedure. However, survival rates appear to be similar between device types, and the evidence does not clearly support the superiority of one device over another in all patients. Two sex-specific studies were also identified in a literature search with the objective of observing mortality rates in women undergoing TAVI or SAVR. Results were varied, and further study is needed. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at intermediate risk for open surgery who receive TAVI, the evidence includes 3 RCTs comparing TAVI with surgical repair including individuals at intermediate surgical risk, 2 RCTs only in patients with intermediate risk, and multiple systematic reviews and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Five RCTs have evaluated TAVI in patients with intermediate risk for open surgery. Three of them, which included over 4000 patients combined, reported noninferiority of TAVI vs SAVR for their composite outcome measures (generally including death and stroke). A subset analysis of patients (n=383) with low and intermediate surgical risk from a fourth trial reported higher rates of death at 2 years for TAVI vs SAVR. The final study (N=70) had an unclear hypothesis and reported 30-day mortality rates favoring SAVR (15% vs 2%, p=0.07) but used a transthoracic approach. The rates of adverse events differed between groups, with bleeding, cardiogenic shock, and acute kidney injury higher in patients randomized to open surgery and permanent pacemaker requirement higher in patients randomized to TAVI. Subgroup analyses of meta-analyses and the transthoracic arm of the Leon et al RCT has suggested that the benefit  of TAVI may be limited to patients who are candidates for transfemoral access. Although several RCTs have 2 years of follow-up postprocedure, it is uncertain how many individuals require reoperation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at low risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals selected without specific surgical risk criteria but including patients at low surgical risk, systematic reviews, and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Limited data are available comparing SAVR with TAVI in patients who had severe aortic stenosis with low risk for open surgery. A systematic review including the low surgical risk patients of these 2 RCTs, and 4 observational studies, with propensity score matching, reported that the 30-day and inhospital mortality rates were similar for TAVI (2.2%) and SAVR (2.6%). However, TAVI was associated with increased risk of mortality with longer follow-up (median, 2 years; 17.2% vs 12.7%). TAVI was associated with reduced risk for bleeding, renal failure and, an increase in vascular complications and pacemaker implantation compared with SAVR. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have valve dysfunction and aortic stenosis or regurgitation after aortic valve repair who receive transcatheter aortic “valve-in-valve” implantation, the evidence includes case series (largest included 459 patients) and systematic reviews of case series. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. These case series have reported high rates of technical success of valve implantation and improvement in heart-failure symptoms for most patients. However, they have also reported high rates of shortterm complications and high rates of mortality at 1 year postprocedure. There is a lack of evidence comparing valve-in-valve replacement with alternative treatment approaches. The evidence is insufficient to determine the effects of the technology on health outcomes.

Thursday, November 1, 2018

CPT 82310, 84590, 82725, 86353, 88348 - Calcium, Vitamin A procedurces


Code Description CPT

82310 Calcium; total
82725 Fatty acids, nonesterified
84590 Vitamin A
84591 Vitamin, not otherwise specified
84999 Unlisted chemistry procedure
86353 Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis
88348 Electron microscopy, diagnostic


Introduction
Micronutrients are essential vitamins and minerals. Getting enough of them is important for good health. It’s rare in the United States to have medical conditions caused by lack of nutrients like vitamins A, B1, B12, C, and D, and selenium. Most people get enough vitamins and minerals through their diet or over-the-counter vitamins. Blood samples are a proven way to measure the level of essential nutrients. Other tests have been created that look at nutrient levels inside cells.

These tests are unproven. There are no published medical studies showing whether the cell tests are more accurate or useful than standard blood tests at measuring levels of vitamins or minerals. There are also no randomized controlled trials — studies that randomly put people in different study groups — exploring whether the cell tests are effective to screen for or diagnose nutrient deficiencies.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.



When reviewing intracellular micronutrient panel testing, the entire panel is to be reviewed as a whole versus the individual elements of the panel.

Reference Laboratories (see Benefit Application)
IntraCellular Diagnostics
IntraCellular Diagnostics uses electron microscopy for which CPT code 88348 might be reported.

SpectraCell Laboratories

According to SpectraCell Laboratories, their total antioxidant function testing (SPECTROX®) is reported using CPT code 86353.

Benefit Application

This testing is currently only available through two reference laboratories: SpectraCell Laboratories (Houston, TX) and IntraCellular Diagnostics (Medford, OR).

Evidence Review Description

Commercial laboratories offer panels of tests evaluating intracellular levels of micronutrients (essential vitamins and minerals). Potential uses of these tests include screening for nutritional deficiencies in healthy people or those with chronic disease and aiding in the diagnosis of disease in patients with nonspecific symptoms.
Background

Vitamin Deficiencies

“Micronutrients” collectively refer to essential vitamins minerals necessary in trace amounts for health. Clinical deficiency states (states occurring after prolonged consumption of a diet lacking the nutrient and is treated by adding the nutrient to the diet) have been reported for vitamins A, B1, B12, C, and D, selenium, and other micronutrients. Classic nutritional deficiency diseases are uncommon in the United States; most people derive sufficient nutrition from their diets alone or in combination with over-the-counter multivitamins. Laboratory tests are available for individual micronutrients and are generally used to confirm suspected micronutrient deficiencies. Testing is performed by serum analysis using standardized

values for defining normal and deficient states. In addition, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.

Diagnostic Testing

This policy evaluates novel laboratory tests that measure the intracellular levels of micronutrients. This testing, also known as intracellular micronutrient analysis, micronutrient testing or functional intracellular analysis is claimed to be superior to serum testing because intracellular levels reflect more stable micronutrient levels over longer time periods than serum levels and because intracellular levels are not influenced by recent nutrition intake. However, the relation between serum and intracellular levels of micronutrients is complex. The balance of intra- and extracellular levels depends on a number of factors, including the physiology of cellular transport mechanisms and the individual cell type.

At least 2 commercial laboratories offer intracellular testing for micronutrients. Laboratories perform a panel of tests evaluating the intracellular level of a variety of micronutrients (eg, minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics evaluates epithelial cells from buccal swabs and assesses levels of intracellular mineral electrolyte (ie, magnesium, calcium, potassium, phosphorous, sodium, chloride). SpectraCell Laboratories offers a panel of tests that evaluates the intracellular status of micronutrients within lymphocytes in blood samples. The micronutrients measured by the test include:

* Vitamins: A, B1, B2, B3, B6, B12, C, D, K; biotin, folate, pantothenic acid
* Minerals: calcium, magnesium, zinc, copper
* Antioxidants: alpha lipoic acid, coenzyme Q10, cysteine, glutathione, selenium, vitamin E
* Amino acids: asparagine, glutamine, serine
* Carbohydrate metabolism: chromium, fructose sensitivity, glucose-insulin metabolism
* Fatty acids: oleic acid
* Metabolites: choline, inositol, carnitine

The SpectraCell micronutrient panel also includes an evaluation of total antioxidant function.

Summary of Evidence

For individuals who have chronic diseases or nonspecific generalized symptoms who receive intracellular micronutrient analysis, the evidence includes observational studies. Relevant  outcomes are test accuracy, symptoms, and change in disease status. No studies were identified that evaluated clinical validity or clinical utility of intracellular micronutrient testing compared with standard testing for vitamin or mineral levels. Limited data from observational studies are available on correlations between serum and intracellular micronutrient levels. No randomized controlled trials or other comparative studies were identified evaluating the direct health impact of intracellular micronutrient testing. Moreover, there are insufficient data to construct a chain of evidence that intracellular micronutrient testing would likely lead to identifying patients whose health outcomes would be improved compared with alternative approaches to patient management. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing snd Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2018 did not identify any ongoing or unpublished trials that would likely influence this review. Practice Guidelines and Position Statements No guidelines or statements were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

Monday, August 20, 2018

Visit payment and Episode claiming

VISIT PAYMENT POLICIES AND THE TRANSITION OF EPISODE CLAIMING:

A “visit” is defined as a unit of service consisting of all the APG services preformed for a patient that are coded on the same claim and share a common date of service. There may be multiple APGs associated with a visit, depending on the services provided. Upon initial APG implementation (Dec. 2008), the “visit” was the basic unit for payment.

As of July 1, 2009, for hospitals, most ancillary laboratory or radiology services associated with a medical visit and/or a significant procedure billed under the APG payment methodology became the fiscal responsibility of the APG provider and had to be included on the APG claim, even if the ancillary services were provided by outside vendors or on different dates of service. This ancillary policy will also apply to D&TCs prospectively effective January 1, 2011. Consistent with this change, new rate codes were issued for hospital OPDs and will be issued for DT&C clinics which enable the APG Grouper/Pricer to recognize an “episode” of care. An “episode” is defined as a unit of service consisting of all services on a claim, regardless of the coded dates of service. Under episode billing an episode shall consist of all medical visits and or procedures that are provided by a clinic to a patient on a single date of service plus any associated non-carved out ancillary laboratory or radiology services, regardless of the date of service of those ancillaries. Under episode claiming, multiple episodes should not be coded on the same claim or the payment could be subject to excessive packaging, consolidating, and/or discounting.

For emergency departments, the significant procedures and/or medical visits comprising the non-carved out ancillary services portion of an episode need not be on a single date of service and may instead be on consecutive dates of service.

USE OF VISIT AND EPISODE RATE CODES:

The EAPG Grouper/Pricer is programmed to use two grouping mechanisms for billing purposes. The “visit” grouping mechanism applies APG packaging, consolidation, and discounting to all services on a claim with the same date of service. With visit billing there can be more than one visit on the claim and each visit will process separately through the grouper/pricer based on the coded dates of service. The “episode” grouping mechanism applies APG packaging, consolidation, and discounting to all services on a claim regardless of the date of service.

Therefore, on an episode claim there can be only one visit/episode on the claim and date of service is ignored by the grouper/pricer.

Visit Rate Codes and Ancillaries: When using visit rate codes to claim for a visit, all associated ancillary or radiology services must be reported on the same claim as the medical visit or significant procedure that generated the ancillary service. For claiming purposes, providers must reassign the dates of ancillary lab or radiology services to correspond with the date of the medical visit or significant procedure that generated the ancillary service. If the dates of the ancillaries are not reassigned, it is likely that they will be viewed by the grouper/pricer as “if stand alone, do not pay procedures” and no payment will be made. To avoid the reassignment of dates that can be necessary under visit claiming, NYS DOH implemented the episode claiming option, whereunder correct dates of service can be coded for the ancillaries and they will still group with, and be paid with, the relevant/associated medical visit or significant procedure. While multiple visits may be reported on the same claim when using visit rate codes, the Grouper/ Pricer will apply the APG grouping logic to all services and procedures with the same date of service.

All services and procedures provided to a patient with the same date of service and rate code (based on servicing provider type – i.e. OPD, Ambulatory Surgery Center, ED, and D&TC) must be billed together on one claim. If two claims are submitted for the same patient with the same rate code, same date of service, and same provider (hospital or D&TC), only the first claim submitted will result in payment. The second claim will be denied. If a patient returns to the clinic for multiple visits on the same date of service, all the procedures must be billed on one claim with the appropriate APG rate code (1400 for hospital OPDs or 1407 for DTCs). If the provider attempts to submit multiple APG claims for that rate code for the same recipient/same date of service, only one claim will be paid.

All others will be denied as duplicative claims. If a patient is initially seen in the hospital emergency room and the visit ultimately results in the provision of a same-day ambulatory surgery service outside of the emergency room, the hospital should bill the visit only under the ambulatory surgery rate code. Episode Rate Codes: As described above, for purposes of APG reimbursement an “episode of care consists of a medical visit and/or significant procedure that occurred on a single date of service and all the associated ancillary laboratory or radiology services that occurred on or after the date of the medical visit or significant procedure. When using an episode rate code to claim for an episode of care, providers must include a “from” and “to” date in the claim header to reflect the episode of care as well as specific dates at the line level for each service provided as part of the “episode of care.

All procedure codes related to an episode of care should be reported on a single claim with their actual dates of service. This includes the medical visit and or procedures that occurred on a single date of service and all associated ancillary laboratory or radiology services on or after the medical visit or significant procedure, regardless of the provider or date of service. When using an episode rate code, the Grouper/Pricer will apply the APG grouping logic to all services and procedures on the claim, regardless of the dates of service. If procedures from two different episodes of care are coded on the same claim, unwarranted discounting or consolidation may occur, resulting in underpayment to the APG biller.

As with use of the visit rate code, if two claims are submitted by the same APG provider for the same patient, using the same episode rate code and the same “from” date for the episode of care, only the first claim submitted will result in payment. The second claim will be denied.

Note: Implementation of the ancillary billing policy described above will be delayed for DTCs until January 1, 2011.

Therefore, upon implementation of APGs in DTCs through December 31, 2010, ancillary laboratory and radiology services which have historically been referred by DTCs to outside providers or vendors may continue to be billed directly to EMedNY by the ancillary service provider using the appropriate Medicaid fee schedule. During this time period, these ancillary services are not the financial responsibility of the DTC and should not be reported on the

APG claim. However, any ancillary laboratory or radiology service provided directly by the DTC clinic or historically included in the clinic’s former threshold or specialty (e.g. as with former PCAP rate codes) payment should be reported on the APG claim, even those that map to “a never pay APG” or an “if stand alone do not pay APG.”. The ancillary billing policy will be implemented prospectively in DTCs, effective January 1, 2011. Additional guidance on the ancillary billing policy will be issued at that time. In the interim, see Section 4.4 for more information on the APG ancillary billing policy.


APG billers assigned episode rate codes (hospital OPDs, D&TCs, and SBHCs) are expected to use episode rate codes for all claims effective January 1, 2011, except when billing for Medicare/Medicaid dual eligibles or for services routinely billed on a monthly basis. In the interim, APG billers may use either the appropriate visit based rate codes (1400, 1407,1435) or the appropriate new episode of care rate codes( 1432, 1422,1425). After January 1, 2011, visit based rated codes may only be used for claims for Medicare/Medicaid dually eligible patients or for services that are billed for a patient on a monthly basis. The SDOH strongly encourages providers to use episode rate codes as episode rate codes enable more accurate reporting with respect to the date of ancillary lab and radiology services and, when used properly, episode rate codes will always result in as much or more payment than use of a visit rate code for the same bundle of services.

UNITS OF SERVICE:

Generally, the APG reimbursement system does not recognize units of service. However, effective January 1, 2010, providers may bill multiple units of service for a limited group of procedures including physical andoccupational therapy. Additional units-based procedures include nutrition counseling (e.g., CPT 97802 medical nutrition, indiv., 15 min.), crisis management (e.g., CPT H2011 crisis intervention service, 15 min.), patient education including diabetes and asthma self management services rendered by CDEs & CAEs , and health/behavioral assessments (e.g., CPT 96150 assess health behavior, initial).

Providers should not code multiple lines on a single claim with the same HCPCS code (except for dental procedures such as multiple teeth sealed, multiple fillings, etc. – see section 4.2) to signify the provision of multiple units of a single procedure/service. Rather, they should include the HCPCS code on one line along with the number of units of the service provided on that same line. For physician administered drugs and all other services billed in multiple units, providers should bill for each drug  or service on a single claim line and identify the units provided on that line. Drug APGs are set to pay for the average units billed for each APG. Generally drugs are grouped into APGs based on the costs of a typical dosage. When multiple immunizations are rendered on the same date of service, the APG claim should include multiple codes for the administration of vaccine. The first administration code will pay at 100%; subsequent codes will be discounted at 50%.

For a complete list of units-based procedures and their respective unit maximums, please
visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/units_based_procedures.pdf.

3.7 EMERGENCY ROOM – EPISODE OF CARE
:

If a patient enters the Emergency Department (ED) before midnight and leaves after midnight, the Grouper/Pricer  will treat the ED visit as a single episode of care. A single claim should be filed for each ED visit (episode of care) and the actual dates of service for each procedure should be reported on the claim. All ED services should be billed using the ED rate code, 1402.

3.9 UTILIZATION THRESHOLDS:

The Utilization Threshold Program continues to apply to clinic services billed as visits or episodes of care under APGs. Under the Utilization Threshold Program, it is necessary for clinic providers to obtain an authorization from the Medicaid Eligibility Verification System (MEVS) to render services to Medicaid patients. This authorization to render services will be given unless a recipient has reached his/her utilization threshold limit. If the individual’s threshold has been reached, the clinic physician must submit a “Threshold Override Application” (TOA) in order to obtain approval for the additional services.

The Utilization Threshold Program has been revised to provide individual thresholds, which are refreshed quarterly, for every Medicaid recipient based on their health risk status. These new thresholds will be implemented in 2009. Notification of these changes will be forthcoming in a Medicaid Update article. As of March 1, 2010, revised TOA forms must be used. These forms may be obtained by calling the eMedNY call center at (800) 343-9000. The Utilization Threshold Guide is available online at: www.emedny.org/HIPAA/provider_training/training.html.

3.10 REMITTANCE:

The 835 remittance will include line level detail including the APG code, APG full weight, APG allowed percentage, APG paid amount, the payment based on existing operating reimbursement (the blend amount), “combined with CPT” (if reimbursement for a particular CPT/APG has been consolidated or packaged within another CPT/APG, this field indicates the CPT/APG to which payment has been consolidated/packaged), capital add-on amount, and the total payment for the claim. The 835 Companion Guide, which provides detail for all the APG remittance changes, is now available on the www.eMedNY.org website under NYHIPAADESK.

Wednesday, May 9, 2018

Billing guideline for resident physicians, locum tenens provider

SERVICES PROVIDED BY NON-PHYSICIANS AND RESIDENT PHYSICIANS

A. All non-physicians, who are defined as eligible providers under the member’s BCBSKS contract and who are providing services as defined in their Kansas licensure or certification, shall bill their charges to BCBSKS under their own National Provider Identifier (NPI) or specific performing provider number, if applicable. The name of the ordering provider, when applicable, (including NPI, except when exempt by law) must appear on every claim.

B. A physician may bill for the services of a licensed nurse, other than an APRN, if there is an employer/employee relationship and the services are supervised by the physician (supervision means the patient recognizes the supervising physician as his/her physician and there is a periodic review of the records by the physician). These services must be an integral part of the physician's professional service, included in the physician's bill, and be of the type that are commonly furnished in the physician's office or clinic.

C. Independently practicing Advanced Practice Registered Nurses (APRNs) who are providing services as defined in their Kansas licensure or certification, shall bill their charges to BCBSKS under their own NPI or specific performing provider number. The name of the ordering provider, when applicable, (including NPI, except when exempt by law) must appear on every claim.

D. Services of a Resident Physician are billed under the attending Faculty Physician’s NPI or specific performing provider number if done in connection with the Residency Program.

E. If the Resident Physician is providing services outside of the Residency Program, all Blue Shield Policy Memos apply and services shall be billed under his/her own NPI or specific performing provider number.

F. BCBSKS will not pay for any services performed and billed by an independent provider who does not meet applicable state or national licensure registration or certification requirements to perform that service or who is not defined as an eligible provider in the member’s contract.

G. BCBSKS will not pay for outpatient services connected with a nervous and mental diagnosis when provided by an unlicensed provider, or a licensed provider with a licensure other than designated in the member’s contract as eligible to provide nervous and mental benefits. Supervision of an unlicensed provider, a licensed counselor, or one not designated as eligible in the member’s contract does not constitute a service being rendered by an eligible provider. The exception to this would be if the service was rendered through a state licensed alcohol or drug abuse treatment facility, a hospital, psychiatric hospital, or a community mental health center. Eligible non-physician psychiatric providers include APRNs, certified psychologists, licensed specialist clinical social workers, licensed clinical marriage and family therapists, licensed clinical professional counselors, and licensed clinical psychotherapists.

XIX. LOCUM TENENS PROVIDER

In situations in which the regular provider is unavailable, a locum tenens can be used to provide a visit/service. The locum tenens must be the same type of provider as for whom the locum is substituting (for example, a physician can only authorize another physician as a locum tenens, an APRN/PA can only authorize another APRN/PA, etc.) and the locum tenens must be licensed in Kansas and only perform within his/her scope of license. The locum tenens must not provide services during a continuous period of longer than 60 days. For situations extending beyond 60 days, BCBSKS must be contacted to discuss billing arrangements.

In billing for services provided by a locum tenens, the claim must be filed using the NPI or specific performing provider number of the provider for whom the locum tenens is substituting and a Q6 modifier must be used. In addition, the medical record must indicate the services were provided by a locum tenens.

Monday, January 8, 2018

Enteral Nutrition Billing Guide


ENTERAL NUTRITION

Enteral nutrition is nutrition administered by tube or orally into the gastrointestinal tract. Enteral nutrition is classified into categories that possess similar characteristics. Categories for enteral nutrition are listed by HCPCS codes on the MDHHS Medical Supplier/DME/Prosthetics and Orthotics Fee Schedule on the MDHHS website. For the appropriate HCPCS code, products are listed on the enteral nutrition product classification list on the website for the Medicare Pricing, Data Analysis and Coding (PDAC) contractor. If the formula is not listed in the covered HCPCS codes, the provider must contact the PDAC contractor for a coding determination. (Refer to the Directory Appendix for website and contact information.)



ENTERAL NUTRITION (ADMINISTERED ORALLY)

Standards of Coverage

Enteral nutrition (administered orally) may be covered for beneficiaries under the age of 21 when:

* A chronic medical condition exists resulting in nutritional deficiencies, and a threemonth trial is required to prevent gastric tube placement; or

* Supplementation to regular diet or meal replacement is required, and the beneficiary's weight-to-height ratio has fallen below the fifth percentile on standard growth grids; or

* Physician documentation details low percentage increase in growth pattern or trend directly related to the nutritional intake and associated diagnosis/medical condition.

For CSHCS coverage, a nutritionist or appropriate pediatric subspecialist must indicate that long-term enteral supplementation is required to eliminate serious impact on growth and development.

For Healthcare Common Procedure Coding System (HCPCS) code B4162, the beneficiary must have a specified inherited disease of metabolism identified by the International Classification of Diseases (ICD).


For beneficiaries age 21 and over:

* The beneficiary must have a medical condition that requires the unique composition of the formula nutrients that the beneficiary is unable to obtain from food; or

* The nutritional composition of the formula represents an integral part of treatment of the specified diagnosis/medical condition; or

* The beneficiary has experienced significant weight loss. For Healthcare Common Procedure Coding System (HCPCS) code B4157, the beneficiary must have a specified inherited disease of metabolism identified by the International Classification of Diseases (ICD).

Documentation Documentation must be less than 30 days old and include:

* Specific diagnosis/medical condition related to the beneficiary's inability to take or eat food.

* Duration of need.

* Amount of calories needed per day.

* Current height and weight, as well as change over time. (For beneficiaries under 21, weight-to-height ratio.)

* Specific prescription identifying levels of individual nutrient(s) that is required in increased or restricted amounts.

* List of economic alternatives that have been tried.

For continued use beyond 3-6 months, the CSHCS Program requires a report from a nutritionist or appropriate pediatric subspecialist.


PA Requirements PA is required for all enteral formula for oral administration.

The following HCPCS codes require authorization via a telephone authorization process:

B4034 B4035 B4036 B4081 B4082 B4083 B4087 B4088 B4102 B4149 B4150 B4152 B4153 B4154 B4155 B4157 B4158 B4159 B4160 B4161 B4162 B9000 B9002 B9998

Refer to the Directory Appendix for Telephone Prior Authorization Contractor information.


ENTERAL NUTRITION (ADMINISTERED BY TUBE)

Standards of Coverage

Enteral formula are covered when the diagnosis/medical condition requires placement of a gastric tube and nutrition is administered by syringe, gravity, or pump.

Documentation Documentation must be less than 30 days old and include:

* Specific diagnosis/medical condition requiring tube feeding.

* Duration of treatment.

* Amount needed per day.

* If a pump is required, the medical reason why syringe or gravity method could not be used.

PA Requirements PA is not required for standard formula for enteral tube feedings provided up to the program's established quantity limits per month. (Applies only to specific enteral formula and related supplies and equipment. Refer to the Medicaid Code and Rate Reference tool for additional information.)

PA is required for the following:

* All specialized enteral formula requests for tube feedings.

* Over-quantity requests for standard formula enteral tube feedings.

* Medical need beyond Standards of Coverage.

The following HCPCS codes require authorization via a telephone authorization process:

B4034 B4035 B4036 B4081 B4082 B4083 B4087 B4088 B4102 B4149 B4150 B4152 B4153 B4154 B4155 B4157 B4158 B4159 B4160 B4161 B4162 B9000 B9002 B9998

Refer to the Directory Appendix for Telephone Prior Authorization Contractor information.



ENTERAL NUTRITION PAYMENT RULES

When billing for enteral formula (administered orally or by tube), the appropriate formula HCPCS code should be billed on a monthly basis with total calories used (divided by 100) as the unit amount. (To calculate the appropriate number of caloric units, combine total calories of all cans to be used and divide by 100.) Medicaid will reimburse for a maximum quantity of up to 900 units for any combination of approved formula.

Providers should refer to the following chart for additional assistance:

Formula 100 calories = 1 unit (u) 6 (8 oz) cans a day

1 month = 30 days

6 months = 180 days

5.00 cost/8 oz liquid or packet or can Standard @ 250 calories/8 oz 250 cals/100 =2.5 units 2.5 u x 6 = 15 units a day
15 u x 30 = 450 units a month 15 u x 180=2700 units for 6 months $5.00 ÷ 2.5 u = $2.00 per unit Caloric Dense @ 355
calories/8 oz 355 cals/100 =3.55 units 3.55 u x 6= 21 units a day 21 u x 30 = 630 units a month 21 u x 180 =
3780 units for 6 months $5.00 ÷ 3.55 u = $1.41 per unit Powder, 1 package = 150 calories 150 cals/ 100
= 1.5 units 1.5 u x 6 = 9  nits a day 9 u x 30 = 270 units a month 9 u x 180 =1620 units for 6 months $5.00 ÷ 1.5 u =
$3.33 per unit Powder, 1# can = 112 oz when mixed @ 20 calories/oz* = 2240 calories for the entire can

(*can vary with physician orders) 2240 cals/100 = 22.4 units 6 cans per month = 22.4 u x 6 = 134 units a month 134 u x 6 months = 804 units for 6 months $5.00 ÷ 22.4 u = $0.30 per unit

The necessary equipment and supply code for enteral tube feedings should be billed up to specified quantity limits. Feeding bags, anchoring devices, syringes, drain sponges, cotton tip applicators, tape, adaptors, and connectors used in conjunction with a gastrostomy or enterostomy tube are included in the supply kit codes and should not be billed separately.

Dietary formula for oral feedings may be obtained from either a medical supplier or a pharmacy.

Dietary formula for tube feedings are covered only through the medical supplier.

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