Sunday, July 21, 2019

CPT S0390, 11055, 11056, 11057, 11719, 11721, G0127, - Routine Foot Care Services

Coding   code Description CPT

11055 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); single lesion

11056 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions

11057 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); more than 4 lesions

11719 Trimming of nondystrophic nails, any number

11720 Debridement of nail(s) by any method(s); 1 to 5

11721 Debridement of nail(s) by any method(s); 6 or more

G0127 Trimming of dystrophic nails, any number

S0390 Routine foot care; removal and/or trimming of corns, calluses and/or nails and preventive maintenance in specific medical conditions (eg, diabetes), per visit

Routine Foot Care Services


Introduction


Most adults are able to provide their own routine foot care, such as trimming nails or filing calluses. Therefore, this type of foot care is not covered under the medical benefits. However, for some individuals with certain medical conditions, it may be important to have professional help with routine foot care in order to prevent serious problems. Routine foot care includes services such as cutting corns and calluses or trimming, cutting, clipping, or removing part of the nail (debridement). This benefit coverage guideline discusses when routine foot care 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 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. 
Coverage Guideline 

Indication Medical Necessity

Conditions associated with poor blood flow to the legs and feet

Routine foot care may be considered medically necessary for patients with conditions associated with poor blood flow to the legs and feet such as peripheral vascular disease and/or numbness (desensitization). 


Indication Medical Necessity

Routine foot care Routine foot care, such as trimming nails or removing corns and calluses, does not typically require the skills of a qualified provider of foot care services and is therefore considered not medically necessary.



ICD-10 Diagnosis Codes - Covered
A52.16 Charcot's arthropathy (tabetic)
B35.1 Dermatophitosis (Tinea unquium)
B37.2 Candidiasis of skin and nail
B52.0 Plasmodium malariae with neuropathy
E08.00 – E13.9 Diabetes Mellitus
O24.011 – O24.93 Diabetes mellitus in pregnancy
G13.0 – G13.1 Systemic atrophy and neuropathy
G6281 – G65.2 Polyneuropathies


Code Description
G73.3 Myasthenic syndromes in other diseases classified elsewhere
G90.09 Peripheral neuropathy
G99.0 Autonomic neuropathy
I70.201 – I70.799 Atherosclerosis of arteries, lower extremities
I73.00 – I79.8 Peripheral vascular disease
I80.00 – I80.3 Phlebitis and thrombophlebitis, lower extremities
I82.501 – I87.9 Chronic embolism and thrombosis, lower extremities
I89.0 Lymphedema
I99.8 Circulatory system disorder
L02.415 – L03.129 Infections of skin and subcutaneous tissue, lower limb
L11.0 Acquired keratosis follicularis
L60.0 – L60.9 Nail disorders
L84 – L85.2, L86, L87.0, L87.2, L97.501 – L97.529
Disorders of skin and subcutaneous tissue
M05.571 – M05.59 Polyarthropathies
M14.671 – M14.69 Arthropathies, Charcot's joint, ankle and foot  
M20.10 – M02.12 Hallus valgus
M34.83 Systemic sclerosis with polyneuropathy
M90.561 – M90.59 Osteonecrosis, lower ley, ankle and foot
M90.861 – M90.89 Osteopathy, lower leg, ankle and foot
Q82.0 Hereditary lymphedema
R20.0 – R20.9 Disorders of skin and subcutaneous tissue
R60.0 – R60.9 Edema
Note:  CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).


This coverage guideline describes the clinical indications for routine foot care services.  

Routine foot care includes:

* Cutting or removal of corns and calluses
* Trimming, cutting/clipping and debridement of nails

Generally, routine foot care services are performed by the member or the caregiver. However, if certain medical conditions are present they may pose a hazard when foot care is performed by a non-professional. 

The following conditions may pose a risk to life or limb loss, so a qualified provider of foot care services should perform the routine foot care. Conditions that may require a qualified provider to perform routine foot care include but are not limited to any of the following:

* Arteriosclerosis of the extremities
* Buerger’s disease (ie, thromboangiitis obliterans)
* Chronic thrombophlebitis of lower extremities
* Diabetes
* Peripheral neuropathies
* Peripheral vascular disease

This policy only addresses routine foot care. It does not address the treatment of symptomatic diseases and medical conditions of the feet, which may include:
* Bunion
* Bursitis
* Hammer toe
* Heel spur
* Ingrown toenail
* Neuroma
* Plantar fasciitis
* Sprain/strain of the foot
* Warts, including

Monday, March 11, 2019

CPT 0008M, 81460, 81465, 81504, 81520 , S3854 - Patients with Breast Cancer

Code Description CPT

0008M Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk  score (Prosigna) (code terminated 1/1/18)

81460 Whole mitochondrial genome (eg, Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with  ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]), genomic sequence, must include sequence  analysis of entire mitochondrial genome with heteroplasmy detection 

81465 Whole mitochondrial genome large deletion analysis panel (eg, Kearns-Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy


Code Description  detection, if performed 

81504 Oncology (tissue of origin), micro-array gene expression profiling of >2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores 

81519 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score (Oncotype DX)

81520 Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score (new code effective 1/1/18)

81521 Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping genes, utilizing fresh frozen or formalin-fixed paraffinembedded tissue, algorithm reported as index related to risk of distant metastasis (new code effective 1/1/18)

HCPCS

S3854 Gene expression profiling panel for use in the management of breast cancer treatment 




Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer


Introduction
Breast cancer is a complex disease. Scientists are learning more about breast cancer every year. In the past decade research has shown that measuring certain genes or markers in breast cancer tissue may provide information about prognosis that can be used to make decisions about therapy. Therapies for breast cancer may include surgery, radiation and chemotherapy. The size of the cancer, whether lymph nodes are involved, and what markers or genes are present in the cancer are all factors that are used to select the best treatments for a person with breast cancer. A number of tests are now offered which are specifically for early-stage, hormone-receptorpositive breast cancer. These tests provide an estimate of how likely the cancer is to recur after treatment. Using these tests, some women may decide not to have chemotherapy as a treatment when there is a low risk of recurrence. This policy describes when genetic testing to help make decisions about adjuvant treatment after breast cancer surgery may be considered medically necessary and paid for by the health plan. It also describes which tests the plan covers. Some tests need more published studies to show that they accurately describe the risk of recurrence, and those tests are considered investigational by the plan, and would not be paid for.


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 

Test  Medical Necessity  21-Gene reverse transcriptase polymerase chain reaction (RT-PCR) assay:

* Oncotype DX® * EndoPredict® * Breast Cancer Index® * Prosigna®

These tests may be considered medically necessary to determine recurrence risk in women with primary, invasive breast cancer meeting ALL of the following characteristics: * Unilateral tumor * Hormone receptor*positive (that is, estrogen receptor [ER]+
(positive) , or progesterone receptor [PR]+ (positive)) * Human epidermal growth factor receptor 2 (HER2)*(negative)  * Tumor size 0.6 to 1 cm with moderate/poor differentiation or  unfavorable features OR tumor size larger than 1 cm * Node-negative (lymph nodes with micrometastases which are  <2 adjuvant="" are="" aromatase="" be="" br="" chemotherapy="" considered="" decide="" eg="" endocrine="" in="" individual="" inhibitors="" mm="" nbsp="" negative="" node="" of="" on="" size="" tamoxifen="" test="" the="" therapy="" to="" treated="" use="" used="" will="" with="">treat the patient’s breast cancer (when chemotherapy is a therapeutic option)
* The test is ordered within 6 months after diagnosis * Only one of the tests is covered per individual tumor
o In unusual circumstances such as test failure or testing two separate breast cancers, individual consideration is applied

The use of these tests for other indications not outlined above are considered investigational, including but not limited to the following:  * Determination of  recurrence risk in invasive breast cancer  patients with positive lymph nodes


Test  Medical Necessity

* Predicting recurrence risk in patients with noninvasive ductal carcinoma in situ(ie, Oncotype DX® DCIS)
* Patients with bilateral breast cancer * The use of gene expression assays in men with breast cancer * To consider length of treatment with tamoxifen

Test Investigational  MammaPrint® BluePrint®

Use of 70 gene signature (MammaPrint®) for any indication is considered investigational.  The use of BluePrint® in conjunction with MammaPrint® or alone is considered investigational.

TargetPrint® Use of gene expression assays for quantitative assessment of ER, PR, and HER2 overexpression (eg, TargetPrint®) is considered investigational.
Other gene expression assays

Coding 

The use of other gene expression assays (Mammostrat® Breast Cancer Test, BreastOncPx™, NexCourse® Breast IHC4, BreastPRS™) for any indication is considered investigational.


Related Information 

Note About Testing

This policy addresses gene expression profiling in women. No peer reviewed published medical literature on the use of gene expression profiling in men with breast cancer has been identified.

Suggested Testing Management

The 21-gene RT-PCR assay Oncotype DX should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (ie, the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician- patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted for testing. It is not necessary to conduct testing on each tumor; treatment is based on the most aggressive lesion  Unfavorable features that may prompt testing in tumors from 0.6 to 1 cm in size include the following: angiolymphatic invasion, high histologic grade, or high nuclear  grade.

The 21-gene reverse transcriptase polymerase chain reaction (RT-PCR) assay Oncotype DX® should not be ordered as a substitute for standard estrogen receptor, progesterone receptor, or human epidermal growth factor receptor 2 (HER2) testing. 

The current American Society of Clinical Oncology/College of American Pathologists joint guidelines on HER2 testing in breast cancer (Wolff et al, 2013) has defined positive, negative, and equivocal HER2 test results.

Evidence Review 

Description

Laboratory tests have been developed that detect the expression, via messenger RNA, of many different genes in breast tumor tissue and combine the results into a prediction of distant recurrence risk for women with early-stage breast cancer. Test results may help providers and patients decide whether to include adjuvant chemotherapy in postsurgical management of breast cancer or to alter treatment in patients with ductal carcinoma in situ (DCIS) , or to recommend extended endocrine therapy in patients who are recurrence-free at 5 years. This report summarizes the evidence of 5 tests, which are organized by indication: Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint, and Prosigna


Wednesday, February 13, 2019

CPT 37243, 75894, 79445, S2095 - Metastatic Tumors of the Liver

Code Description CPT

37243 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.

75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation

79445 Radiopharmaceutical therapy, by intra-arterial particulate administration

S2095 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using ytrrium-90 microspheres


Radioembolization for Primary and Metastatic Tumors of the Liver

Introduction


Embolization is procedure to block blood flow. Combined with radiation, it is a way to treat cancer in the liver in some situations. In this procedure a catheter (a long, thin, hollow tube) is inserted in an artery near the groin. It’s threaded to the tumor’s blood supply. Tiny radioactive particles are released into the artery that feeds the tumor. The particles travel into the tumor and block off — embolize — the blood supply feeding the tumor, causing it to shrink. The radiation works to kill the cancer cells. The radiation dissipates in a few weeks and the particles stay in the liver permanently. The radiation usually doesn’t affect the healthy liver tissue around the tumor very much. This policy describes when radioembolization may be considered medically necessary.




Policy Coverage Criteria


Service Medical Necessity 


Radioembolization Radioembolization may be considered medically necessary in the following situations: * Treatment of primary hepatocellular carcinoma that is  unresectable and limited to the liver (size of 3cm or larger, and patient with good performance status)   OR * Treatment of primary hepatocellular carcinoma as a bridge to  liver transplantation OR * Treatment of primary intrahepatic cholangiocarcinoma in  patients with unresectable tumors OR * Treatment of hepatic metastases from neuroendocrine tumors  (carcinoid and noncarcinoid) with diffuse and symptomatic disease when systemic therapy has failed to control symptoms. (symptoms related to excess hormone production)  OR * Treatment of unresectable hepatic metastases 

o From breast, colorectal or melanoma (ocular or cutaneous)       AND  o That are progressive and unresectable in patients with liver dominant disease
AND o That are refractory to chemotherapy or are not candidates  for chemotherapy   Service Investigational  Radioembolization Radioembolization is considered investigational for all other hepatic metastases except as noted in the Medical Necessity section above. 


Service Investigational

Documentation Requirements


Radioembolization is considered investigational for all other indications not described in the Medical Necessity section above.

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include office visit notes that contain the relevant history and physical supporting ANY of the following situations: * Patient with primary liver cancer that cannot be removed by surgery and limited to the liver  (size of 3 cm or larger, and patient with good performance status) * Treatment for hepatocellular carcinoma before a liver transplant *
Treatment of primary   intrahepatic cholangiocarcinoma that cannot be removed by surgery * Treatment of hepatic metastases from neuroendocrine tumors (carcinoid and noncarcinoid)  with diffuse and symptomatic disease when systemic therapy has failed to control symptoms (symptoms related to excess hormone production)

* Treatment of hepatic metastases that cannot be removed by surgery: o From breast, colorectal, or melanoma (ocular or cutaneous)

AND o That are progressive and unresectable in patients with liver dominant disease ND * Has failed chemotherapy or are not candidates for chemotherapy




Related Information


In general, radioembolization is used for unresectable hepatocellular carcinoma that is greater than 3 cm.

There is little information on the safety or efficacy of repeated radioembolization treatments or about the number of treatments that should be administered.

Radioembolization should be reserved for patients with adequate functional status (Eastern Cooperative Oncology Group Performance Status 0-2), adequate liver function and reserve, Child-Pugh class A or B, and liver-dominant metastases.

Symptomatic disease from metastatic neuroendocrine tumors refers to symptoms related to excess hormone production.

Definition of Terms

Child-Pugh Score: This score is used to assess the prognosis of chronic liver disease, usually cirrhosis. 

Eastern Cooperative Oncology Group (ECOG): The ECOG performance status is used to assess the patient’s disease progression and how the disease impacts the patient’s activities of daily living (ADLs). http://www.ecog.org/  (Accessed September 2018)


Description

Radioembolization (RE), also referred to as selective internal radiotherapy, delivers small beads (microspheres) impregnated with yttrium 90 intra-arterially via the hepatic artery. The microspheres, which become permanently embedded, are delivered to tumors preferentially, because the hepatic circulation is uniquely organized, whereby tumors greater than 0.5 cm rely on the hepatic artery for blood supply while the normal liver is primarily perfused via the portal vein. Radioembolization has been proposed as a therapy for multiple types of primary and metastatic liver tumors.

Background

Treatments for Hepatic and NeuroEndocrine Tumors


The use of external-beam radiotherapy and the application of more advanced radiotherapy approaches (eg, intensity-modulated radiotherapy) may be of limited use in patients with multiple diffuse lesions due to the low tolerance of normal liver to radiation compared with thehigher doses of radiation needed to kill the tumor.

Various nonsurgical ablative techniques have been investigated that seek to cure or palliate unresectable hepatic tumors by improving locoregional control. These techniques rely on extreme temperature changes (cryosurgery or radiofrequency ablation), particle and wave physics (microwave or laser ablation), or arterial embolization therapy including chemoembolization, bland embolization, or radioembolization.

Radioembolization

Radioembolization, (radiotherapy in older literature) delivers small beads (microspheres) impregnated with yttrium 90 intra-arterially via the hepatic artery. The microspheres, which become permanently embedded, are delivered to tumors preferentially because thehepatic circulation is uniquely organized, whereby tumors greater than 0.5 cm rely on the hepatic arteryfor blood supply while normal liver is primarily perfused via the portal vein. Yttrium-90 is a pure beta-emitter with a relatively limited effective range and short half-life that helps focus the radiation and minimize its spread. Candidates for radioembolizationare initially examined by hepatic angiogram to identify and map the hepatic arterial system. At that time, a mixture of technetium 99-labeled albumin particles is delivered via the hepatic artery to simulate  microspheres. Single-photon emission computed tomography is used to detect possible shunting of the albumin particles into gastrointestinal or pulmonary vasculature.

Currently 2 commercial forms of yttrium-90 microspheres are available: a glass sphere, (TheraSphere) and a resin sphere (SIR-Spheres). Noncommercial forms are mostly used outside the United States. While the commercial products use the same radioisotope (yttrium-90) and have the same target dose (100 Gy), they differ in microsphere size profile, base material (ie, resin vs glass), and size of commercially available doses. The physical characteristics of the active and inactive ingredients affect the flow of microspheres during injection, their retention at the tumor site, spread outside the therapeutic target region, and dosimetry calculations. The  Food and Drug Administration (FDA) granted premarket approval of SIR-Spheres for use in combination with 5-floxuridine chemotherapy by hepatic arterial infusion to treat unresectable hepatic metastases from colorectal cancer. In contrast, TheraSphere’s glass sphere was approved under a humanitarian device exemption for use as monotherapy to treat unresectable hepatocellular carcinoma. In 2007, this humanitarian device exemption was expanded to include patients with hepatocellular carcinoma who have partial or branch portal vein thrombosis. For these reasons, results obtained with 1 product do not necessarily apply to other commercial (or non-commercial) products (see Regulatory Status section). 

Thursday, January 17, 2019

CPT 43647,43648, 43881, 43882, E0765 - laparoscopy gastric nerostimulaor

Coding Code Description CPT

43647 Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
43648 Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum
43881 Implantation or replacement of gastric neurostimulator electrodes, antrum, open
43882 Revision or removal of gastric neurostimulator electrodes, antrum, open

HCPCS

E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting
L8680 Implantable neurostimulator electrode, each
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

Introduction
Gastroparesis is a condition in which the normal movement of food from the stomach to the small intestine is drastically slowed or has stopped. This can lead to nausea and vomiting.

Gastric electrical stimulation (GES) is a treatment that sends weak electrical signals to the nerves and smooth muscles in the lower stomach. This treatment helps decrease nausea and vomiting caused by gastroparesis. A small battery-powered device is surgically placed in the skin in the lower belly area. Wires are then placed in the area to be stimulated. This policy discusses when GES may be considered medically necessary. It has also been proposed as a treatment for obesity. The one published medical study that looked at using GES for obesity did not show it improved weight loss. GES for obesity is considered investigational (unproven) because more medical studies are needed.

 Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. Therest 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.


Service Medical Necessity Gastric electrical stimulation

Gastric electrical stimulation may be considered medically necessary in the treatment of chronic, intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology when ALL of the following criteria are met:

* Significantly delayed gastric emptying as documented by standard scintigraphic imaging of solid food AND
* Patient is refractory or intolerant of prokinetic medications and antiemetic medications AND
* Patient’s nutritional status is sufficiently low that total parenteral nutrition is likely to become medically necessary Gastric electrical stimulation is investigational for the treatment of obesity and all other indications.

Documentation Requirements

The medical records submitted for review should document that medical necessity criteria are met. The record should include clinical documentation of ALL of the following:
* Member has chronic, intractable nausea and vomiting secondary to gastroparesis (inability to empty food) caused by diabetes or for an unknown reason
* Significantly delayed gastric emptying confirmed by standard scintigraphic imaging (gastric emptying scan) of solid food
* Member has not responded or is intolerant to the use of prokinetic (antireflux) and antiemetic (antinausea and vomiting) medications
* The need for parenteral nutrition is likely to become medically necessary because of member’s inadequate nutritional status.




Description

Gastric electrical stimulation (GES) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic, postsurgical or idiopathic etiology. The device may be referred to as a gastric pacemaker.

Background

Gastric electrical stimulation (GES, also referred to as gastric pacing) has been investigated primarily as a treatment for gastroparesis. Currently available devices consist of a pulse generator which can be programmed to provide electrical stimulation at different frequencies.

The pulse generator is connected to intramuscular stomach leads, which are implanted during laparoscopy or open laparotomy (see Regulatory Status section). Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal from the stomach. Symptoms include bloating, distension, nausea, and vomiting.

When severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status, and poor glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathologic conditions. Some cases may not be associated with an identifiable cause, and are referred to as idiopathic gastroparesis. Treatment of gastroparesis includes prokinetic agents such as cisapride and metoclopramide, and antiemetic agents such as metoclopramide, granisetron, or ondansetron. Severe cases may require enteral or total parenteral nutrition. GES has also been investigated as a treatment of obesity. It is used to increase a feeling of satiety with subsequent reduction in food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neurohormonal modulation and/or stomach muscle stimulation.

Summary of Evidence

For individuals who have gastroparesis who receive gastric electrical stimulation (GES), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. Five crossover RCTs have been published. A 2017 meta-analysis of these 5 RCTs did not find a significant benefit of GES on the severity of symptoms associated with gastroparesis. Patients generally reported improved symptoms at follow-up whether or not the device was turned on, suggesting a placebo effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

A Hayes Medical Technology Directory report analyzed the evidence (n=10 studies) for GES for the treatment of gastroparesis. The report evaluated controlled studies (n=7studies/18-241 patients) and uncontrolled studies (n=3 studies/131-233 patients). The controlled trials included RCTs (n=3 studies), prospective (n=2), and retrospective studies (n=2). Patients were selected who had symptomatic gastroparesis refractory to medical treatment with diagnoses of diabetic gastric neuropathy or idiopathic gastroparesis. Exclusion criteria included the structural cause of symptoms, psychogenic vomiting, chemical dependency, previous gastric surgery, and pregnancy. Outcomes measured were gastroparesis symptom severity and gastric retention assessed by scintigraphy. Additional outcomes included the need for nutritional support, and changes in antiemetic and/or prokinetic medications. Follow-up timeframe varied among studies, the longest follow-up being four years. The report found poor to fair quality evidence indicating that GES may improve gastroparesis symptoms and gastric emptying as well as decrease the need for nutritional support in some patients with refractory gastroparesis. Overall, GES was found to be safe with the device removal rate ranging from 7%-12% in most studies, primarily due to lack of symptom improvement. It was noted that despite the low quality of the supportive evidence, GES may be an option for patients with debilitating gastroparesis that is refractory to medical treatment (Hayes, 2016 update).

Overall, the evidence for gastric electrical stimulation is not very strong. However, this Premera policy requires that the patient has tried and failed other treatments and that their nutritional status is so depleted that total parenteral nutrition (TPN) may soon become medically necessary. TPN is invasive and not without its own risks. Therefore, even though the evidence for gastric electrical stimulation is not strong and the Enterra Therapy System had only been approved by the FDA under a Humanitarian Device Exemption (HDE), GES may be helpful and allow the patient to avoid the risks associated with receiving ongoing TPN.

For individuals who have obesity who receive GES, the evidence includes 1 published RCT. Relevant outcomes are change in disease status and treatment-related morbidity. The SHAPE trial did not show significant improvement in weight loss with GES compared to sham stimulation. The evidence is insufficient to determine the effects of the technology on health outcomes.

Thursday, December 20, 2018

cpt 43201, 43210, 43236,43257 -Transesophageal Endoscopic Therapies

CPT Coding - Code Description

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43210 Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed

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

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

43499 Unlisted procedure, esophagus



Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Introduction

GERD — gastroesophageal reflux disease — is a long-term medical condition. It’s a digestive problem that affects the ring of muscles between the esophagus (the tube that carries swallowed food to the stomach) and the stomach. When food is swallowed, the muscles at the end of the esophagus open so food can pass into the stomach. The muscles then close to prevent acid and stomach contents from backing up into the esophagus. In GERD, however, the ring of muscles is too weak, and acid can leak back up into the esophagus. GERD is usually treated with changes to lifestyle and diet, or medications, or in some cases a surgery called fundiplication. A number of other treatments have been studied. These include a procedure that is done through the mouth that wraps the upper part of the stomach around the esophagus, the use of radiofrequency energy to try to improve the barrier between the stomach and the esophagus, and the placement of implants or fillers in the esophagus. These procedures are investigational (unproven). More studies are needed to determine if they are as effective as other 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

Transoral incisionless fundoplication (TIF)

Transoral incisionless fundoplication (TIF)(ie, Esophyx®) is considered investigational as a treatment of gastroesophageal reflux disease.

Transesophageal radiofrequency  Transesophageal radiofrequency to create submucosal thermal lesions of the gastroesophageal junction (ie, Stretta® procedure) is considered investigational as a treatment of gastroesophageal reflux disease.

Endoscopic submucosal implantation of a prosthesis or injection of a bulking agent

Endoscopic submucosal implantation of a prosthesis (ie, Gatekeeper™ Reflux Repair System) or injection of a bulking agent (eg, polymethylmethacrylate beads [PMMA], zirconium oxide spheres [ie, Durasphere®]) is considered investigational as a treatment of gastroesophageal reflux disease.



Evidence Review Description


Transesophageal endoscopic therapies are being developed for the treatment of gastroesophageal reflux disease (GERD). A variety of procedures are being evaluated, including transesophageal (or transoral) incisionless fundoplication (TIF), application of radiofrequency  (RF) energy, and injection/implantation of prosthetic devices or bulking agents. Background

GERD is a common disorder characterized by heartburn and other symptoms related to reflux of stomach acid into the esophagus. Nearly all individuals experience such symptoms at some point in their lives; a smaller number have chronic symptoms and are at risk for complications of GERD. The prevalence of GERD has been estimated to be 10% to 20% in the Western world, with a lower prevalence in Asia.1

Pathophysiology


The pathophysiology of GERD involves excessive exposure of the esophagus to stomach acid, which occurs for several reasons. There can be an incompetent barrier between the esophagus and stomach, either due to dysfunction of the lower esophageal sphincter (LES) or incompetence of the diaphragm (eg, a hiatal hernia). Another mechanism is abnormally slow

clearance of stomach acid. In this situation, delayed clearance leads to an increased reservoir of stomach acid and a greater tendency to reflux.

In addition to troubling symptoms, some patients will have more serious disease, which results in complications such as erosive esophagitis, dysphagia, Barrett esophagus, and esophageal carcinoma. Pulmonary complications may result from aspiration of stomach acid into the lungs and can include asthma, pulmonary fibrosis and bronchitis, or symptoms of chronic hoarseness, cough, and sore throat.

Treatment Guidelines on the management of GERD emphasize initial medical management. Weight loss, smoking cessation, elevating the head of the bed, and elimination of food triggers are all recommended in recent practice guidelines.1 Proton pump inhibitors (PPIs) have been shown to be the most effective medical treatment. In a 2010 Cochrane systematic review, PPIs demonstrated superiority to H2-receptor agonists and prokinetics in both network metaanalyses and direct comparisons.

2 Surgical Treatment

The most common surgical procedure used for GERD is laparoscopic Nissen fundoplication. Fundoplication involves wrapping a portion of the gastric fundus around the distal esophagus to increase LES pressure. If a hiatal hernia is present, the procedure also restores the position of the LES to the correct location. Laparoscopic fundoplication was introduced in 1991 and has been rapidly adopted because it avoids complications associated with an open procedure. Although fundoplication results in a high proportion of patients reporting symptom relief, complications can occur and sometimes require conversion to an open procedure. Patients who have relief of symptoms of GERD after fundoplication may have dysphagia or gas-bloat syndrome (excessive gastrointestinal gas).

Other Treatment Options

Due in part to the high prevalence of GERD, there has been interest in creating a minimally invasive transesophageal therapeutic alternative to open or laparoscopic fundoplication or chronic medical therapy. Three types of procedures have been investigated.

1. Transesophageal endoscopic gastroplasty (gastroplication, TIF) can be performed as an outpatient procedure. During this procedure, the fundus of the stomach is folded and then held in place with staples or fasteners that are deployed by the device. The endoscopic procedure is designed to recreate a valve and barrier to reflux

2. Radiofrequency (RF) energy has been used to produce submucosal thermal lesions at the gastroesophageal junction. (This technique has also been referred to as the Stretta procedure.) Specifically, RF energy is applied through 4 electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction. The mechanism of action of the thermal lesions is not precisely known but may be related to ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissuetightening effect related to heat-induced collagen contraction and fibrosis.

3. Submucosal injection or implantation of a prosthetic or bulking agent to enhance the volume of the lower esophageal sphincter has also been investigated. One bulking agent, pyrolytic carbon-coated zirconium oxide spheres (Durasphere®), is being evaluated.

The Gatekeeper™ Reflux Repair System (Medtronic, Shoreview, MN) uses a soft, pliable, expandable prosthesis made of a polyacrylonitrile-based hydrogel. The prosthesis is implanted into the esophageal submucosa, and with time, the prosthesis absorbs water and expands, creating bulk in the region of implantation.

U.S. Food and Drug Administration (FDA)product code: DQX. Endoscopic submucosal implantation of polymethylmethacrylate beads into the lower esophageal folds has also been investigated.

Summary of Evidence

For individuals who have GERD and hiatal hernia of 2 cm or less that is not controlled by PPIs who receive TIF (eg, EsophyX), the evidence includes 2 RCTs comparing TIF with PPI therapy, nonrandomized studies comparing TIF with fundoplication, and case series with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The highest quality RCT (RESPECT) was a sham-controlled together with PPI therapy while the other RCT (TEMPO) compared TIF with maximum PPI therapy. Both trials found a significant benefit of TIF on the primary outcome measure in about 65% of patients, but the sham-controlled trial found improvement in 45% of the sham-

controlled group and no benefit on secondary subjective outcome measures. The nonblinded RCT found significant improvements in subjective measures but no difference in objective outcome measures when compared with PPI therapy. Together, these trials suggest a strong placebo effect of the surgery and a modest benefit of TIF in patients whose symptoms are not controlled by PPIs. For these patients, the most appropriate comparator is laparoscopic fundoplication. Studies comparing TIF with fundoplication have limitations that include earlier TIF procedures and unequal groups at baseline and are inadequate to  determine relative efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have GERD and hiatal hernia of 2 cm or less that is controlled by PPIs who receive TIF (eg, EsophyX), the evidence includes 2 RCTs and observational studies with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. A sham-controlled trial found that the time to resume PPI therapy was longer following TIF and the remission rate was higher, indicating that TIF is more effective than no therapy. The nonblinded RCT found a benefit of TIF compared with continued PPI therapy for subjective measures, but not for the objective measures of pH normalization and esophagitis. These results raise questions about a possible placebo effect for the procedure. Also, observational studies have indicated a loss of treatment effectiveness over time. Adverse events associated with the procedure (eg, perforation) may be severe. At present, the available evidence does not support the use of this intervention in patients whose symptoms are adequately controlled by medical therapy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have GERD who receive endoscopic radiofrequency energy (eg, Stretta), the evidence includes 4 small RCTs, a nonrandomized comparative study, and observational studies with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCTs report improvements in symptoms and quality of life following treatment with RF energy compared with sham controls, however, objective measures of GERD and a meta-analysis of these studies found no significant improvement in outcomes, raising questions about the mechanism of the symptom relief. Symptom relief is reported to be lower than after fundoplication, and reoperations greater. Larger RCTs with longer follow-up, preferably compared with fundoplication, are needed to better define the risks and benefits of this procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have GERD who receive esophageal bulking agents, the evidence includes an RCT and case series. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCT for a single product was  terminated early due to lack of efficacy, while other products have only case series to support use. High-quality data from large RCTs are needed to compare bulking procedures with both sham controls and with the currently accepted treatments for GERD (ie, drug therapy, laparoscopic fundoplication). Well-designed trials should use standardized outcome measures to examine whether subjective improvement (eg, discontinuation of medication therapy, GERD– Health-Related Quality of Life scores) is supported by objective improvement (eg, esophageal acid exposure). The evidence is insufficient to determine the effects of the technology on health outcomes.

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