Saturday, December 8, 2018

CPT 0345T, 0483T, 0484T, 33418, 33419 - Transcatheter Mitral Valve Repair

Code Description CPT

0345T Transcatheter mitral valve repair percutaneous approach via the coronary sinus

0483T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed (new code effective 1/1/18)

0484T Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical) (new code effective 1/1/18)

33418 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

33419 Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure)
 

Transcatheter Mitral Valve Repair

Introduction


The heart has four chambers, two upper and two lower. The mitral valve is between the upper and lower left chambers. After blood has been pumped from the upper left chamber to the lower left chamber, the mitral valve closes. The mitral valve is made up of small pieces of tissue called leaflets. If the leaflets don’t close properly when the left lower chamber pumps blood out to the body some of the blood can leak back into the upper left chamber. This is known as mitral valve regurgitation. Medication can be used to help manage the symptoms of mitral valve regurgitation. Open heart surgery is a treatment option. If a person is too sick for surgery, a nonsurgical procedure may be used to place a clip to close the leaky mitral valve. In this procedure, a long, hollow tube (a catheter) is threaded through a specific vein into the heart. The catheter then becomes the pathway for getting the clip to the mitral valve. Imaging is used to make sure the device is correctly placed. This policy describes when transcatheter mitral valve repair is 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.

Policy Coverage Criteria Service Medical Necessity Transcatheter mitral valve repair (eg, MitraClip® Clip Delivery System)

Transcatheter mitral valve repair using a device approved by the U.S. Food and Drug Administration for use in mitral valve repair may be considered medically necessary for patients with symptomatic, primary mitral regurgitation who are considered at prohibitive risk for open surgery. Prohibitive risk for open mitral valve repair surgery may be determined based on:


* The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR

* The documented presence of a logistic EuroSCORE of 20% or greater

Transcatheter mitral valve repair is considered investigational in all other situations.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* Name of the Food and Drug Administration (FDA) approved device to be used
* Documentation that patient has symptomatic primary mitral regurgitation AND
* Patient is at greater risk for open mitral valve repair surgery based on:
o The documented presence of a Society for Thoracic Surgeons predicted mortality risk of 12% or greater AND/OR
o The documented presence of a logistic EuroSCORE of 20% or greater


Related Information

Indications for Use


The FDA summary of safety and effectiveness data (SSED) from 2013 states the indications for use below: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR of 3+ or greater) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team that includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.12

Repair Device

MitraClip® Clip Delivery System has the U.S. Food and Drug Administration (FDA) approval for the treatment of severe symptomatic degenerative mitral regurgitation (see Regulatory Status).


Evidence Review Description

Transcatheter mitral valve repair (TMVR) is an alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized, particularly in patients with multiple comorbidities, suggesting that there is an unmet need for less invasive procedures for MV repair. One device, MitraClip, has approval from the U.S. Food and Drug Administration for the treatment of severe symptomatic MR due to a primary abnormality of the MV (primary MR) in patients considered at prohibitive risk for surgery.

Background

Mitral Regurgitation

Epidemiology and Classification


Mitral regurgitation (MR) is the second most common valvular heart disease, occurring in 7% of  people older than age 75 years and accounting for 24% of all patients with valvular heart disease.1-2

Patients with MR generally fall into 2 categories — primary (also called degenerative) and secondary (also called functional) MR. Primary MR results from a primary structural abnormality in the valve, which causes it to leak. This leak may result from a floppy leaflet (called prolapse) or a ruptured cord that caused the leaflet to detach partially (called flail).3 Because the primary cause is a structural abnormality, most cases of primary MR are surgically corrected. In contrast, secondary MR results from left ventricular dilatation due to ischemic or dilated cardiomyopathy. This causes the mitral value (MV) leaflets not to coapt or meet in the center.4 Because the valves are structurally normal in secondary MR, correcting the dilated left ventricular using medical therapy is the primary treatment strategy used in the United States.

MR severity is classified as mild, moderate, or severe disease on the basis of echocardiographic and/or angiographic findings (1+, 2+, and 3-4+ angiographic grade, respectively). MR with accompanying valvular incompetence leads to left ventricular volume overload with secondary ventricular remodeling, myocardial dysfunction, and left heart failure. Clinical signs and symptoms of dyspnea and orthopnea may also present in patients with valvular dysfunction.4 Standard Management

Medical Management

Medical management has a primary role in secondary MR. Patients with chronic secondary MR  should receive standard therapy for heart failure with reduced ejection fraction; standardmanagement includes angiotensin converting enzyme inhibitor (or angiotensin II receptor blocker or angiotensin receptor-neprilysin inhibitor), *-blocker and mineralocorticoid receptor antagonist, and diuretic therapy as needed to treat volume overload.3,4

Surgical Management

In symptomatic patients with primary MR, surgery is the main therapy. In most cases, MV repair is preferred over replacement, as long as the valve is suitable for repair and personnel with appropriate surgical expertise are available. The American College of Cardiology and the American Heart Association have issued joint guidelines for the surgical management of MV, which are outlined in Table 1.3

Table 1. Guidelines on Mitral Value Surgery Recommendation COR LOE

MV surgery is recommended for the symptomatic patient with acute severe MR. I B
MV surgery is beneficial for patients with chronic severe MR and NYHA functional class II, III, or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30) and/or end-systolic dimension greater than 55 mm. I B
MV surgery is beneficial for asymptomatic patients with chronic severe MR and mild-tomoderate
LV dysfunction, ejection fraction 0.30 to 0.60, and/or end systolic dimension greater than or equal to 40 mm. I B
MV repair is recommended over MV replacement in the majority of patients with severe chronic
MR who require surgery, and patients should be referred to surgical centers experienced in MV I C

Tuesday, November 27, 2018

CPT 33340 - Percutaneous Left Atrial Appendage Closure Devices

Coding Code Description CPT

33340 Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation


Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation

Introduction


The heart is divided into two upper and two lower chambers. Atrial fibrillation, also called a-fib, occurs when the heart’s upper chambers beat irregularly—and often rapidly. Because blood isn’t pumped out the way that it should be, blood tends to pool in these two upper chambers. Thepooling blood increases the risk of blood clots in the area of the heart called the left atrial appendage. If a blood clot comes loose, it may travel to the brain and cause a stroke. Blood thinners are the usual method of preventing blood clots in people with a-fib. If taking a blood thinner poses too much risk or a person can’t tolerate this medication, placing a device in the heart is a different way of helping to prevent stroke. This device seals off the left atrial appendage. Should a clot develop, the device blocks it from entering the bloodstream. This policy describes when a left atrial appendage closure device is 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.

Policy Coverage Criteria Device Medical Necessity Percutaneous left atrial appendage closure device (eg, the Watchman)

The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure (eg, the Watchman) may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when the following criteria are met:

* There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc score and systemic anticoagulation therapy is recommended AND

* The long-term risks of systemic anticoagulation outweigh the risks of the device implantation (see Related Information) The use of a device with FDA approval for percutaneous left atrial appendage closure (eg, the Watchman) for stroke prevention in patients who do not meet the above criteria is considered investigational.

Device InvestigationalOther percutaneous left atrial appendage closure devices

The use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered investigational.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include ALL of the following:
* Name of the Food and Drug Administration (FDA) device to be used
* CHADS2 or CHA2DS2-VASc score documenting patient’s increased risk of stroke and systemic embolism
* Documentation that systemic anticoagulation therapy is recommended AND the long-term risks of systemic anticoagulation outweigh the risks of the device implantation



Related Information

The balance of risks and benefits associated with implantation of the Watchman device for stroke prevention, as an alternative to systemic anticoagulation with warfarin, must be made on an individual basis.

Bleeding is the primary risk associated with systemic anticoagulation. A number of risk scores have been developed to estimate the risk of significant bleeding in patients treated with systemic anticoagulation. An example is the HAS-BLED score, which has been validated to assess the annual risk of significant bleeding in patients with atrial fibrillation treated with warfarin (Pisters et al, 2010). The score ranges from 0 to 9, based on a number of clinical characteristics (see Table 1).

Table 1: Clinical Components of the HAS-BLED Bleeding Risk Score Letter Clinical Characteristic Points Awarded

H Hypertension 1
A Abnormal renal and liver function (1 point each) 1 or 2
S Stroke 1
B Bleeding 1
L Labile international normalized ratios 1
E Elderly (>65 y) 1


Letter Clinical Characteristic Points Awarded D Drugs or alcohol (1 point each) 1 or 2 Adapted from Pisters et al (2010) Risk of major bleeding in patients with scores of 3, 4, and 5 has been reported at 3.74 per 100 patient-years, 8.70 per 100 patient-years, and 12.5 per 100 patient-years, respectively. Scores of 3 or greater are considered to be associated with a high risk of bleeding, potentially signaling the need for closer monitoring of patients for adverse risks, closer monitoring of international normalized ratio, or differential dose selections of oral anticoagulants or aspirin (January et al, 2014).

Evidence Review Description

Stroke prevention in atrial fibrillation (AF) is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Most embolic strokes originate from the left atrial appendage; therefore, occlusion of the left atrial appendage may offer a nonpharmacologic alternative to anticoagulant medications for this purpose. Multiple percutaneously deployed devices are being investigated for left atrial appendage closure (LAAC). One left atrial appendage device (the Watchman device) has approval from the U.S. Food and Drug Administration for stroke prevention in patients with AF.


Background

Stroke


Stroke is the most serious complication of atrial fibrillation (AF). The estimated incidence of stroke in nontreated patients with AF is 5% per year. Stroke associated with AF is primarily embolic in nature, tends to be more severe than the typical ischemic stroke, and causes higher  rates of mortality and disability. As a result, stroke prevention is one of the main goals of AF treatment.

Stroke in AF occurs primarily as a result of thromboembolism from the left atrium. The lack of atrial contractions in AF leads to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. The area of the left atrium with the lowest blood flow in AF, and, therefore, the highest risk of thrombosis, is the left atrial appendage (LAA). It has been estimated that 90% of left atrial thrombi occur in the LAA.

Treatment Pharmacologic

The main treatment for stroke prevention in AF is anticoagulation, which has proven efficacy. The risk for stroke among patients with AF is evaluated using several factors. Two commonly used scores, the CHADS2 and the CHADS2-VASc score, are described below in Table 2. Warfarin is the predominant anticoagulation agent in clinical use. A number of newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban, have recently received U.S.

Food and Drug Administration (FDA) approval for stroke prevention in nonvalvular AF and have demonstrated noninferiority to warfarin in clinical trials. While anticoagulation is effective for stroke prevention, it carries an increased risk of bleeding. Also, warfarin requires frequent monitoring and adjustments, as well as lifestyle changes. Dabigatran does not require monitoring. However, unlike warfarin, the antithrombotic effects of dabigatran are not reversible with any currently available hemostatic drugs. Guidelines from the American College of Chest Physicians (2012) have recommended the use of oral anticoagulation for patients with AF who are at high risk of stroke (ie, CHADS2 score =2), with more individualized choice of antithrombotic therapy in patients with lower stroke risk.1

Table 2. CHADS2 and CHADS2-VASc Scores to Predict Ischemic Stroke Risk in Patients with Atrial Fibrillation

Letter Clinical Characteristics Points

Awarded


C Congestive heart failure (signs/symptoms of heart failure confirmed with objective evidence of cardiac dysfunction) 1
H Hypertension (resting blood pressure >140/90 mmHg on at least 2 occasions or current antihypertensive pharmacologic treatment)
1 A Age =75 y


Bleeding is the primary risk associated with systemic anticoagulation. Risk scores have been developed to estimate the risk of significant bleeding in patients treated with systemic anticoagulation, such as the HAS-BLED score, which has been validated to assess the annual risk of significant bleeding in patients with AF treated with warfarin.3 The score ranges from 0 to 9, based on a number of clinical characteristics, including the presence of hypertension, renal and liver function, history of stroke, bleeding, labile international normalized ratios, age, and drug/alcohol use. Scores of 3 or greater are considered to be associated with high risk of bleeding, potentially signaling the need for closer monitoring of patients for adverse risks, closer monitoring of international normalized ratios, or differential dose selections of oral anticoagulants or aspirin.2

Surgery

Surgical removal, or exclusion, of the LAA is often performed in patients with AF who are undergoing open heart surgery for other reasons. Percutaneous left atrial appendage closure (LAAC) closure devices have been developed as a nonpharmacologic alternative to anticoagulation for stroke prevention in AF. The devices may prevent stroke by occluding the LAA, thus preventing thrombus formation.

Several versions of LAA occlusion devices have been developed. The Watchman Left Atrial Appendage System (Boston Scientific) is a self-expanding nickel titanium device. It has a polyester covering and fixation barbs for attachment to the endocardium. Implantation is performed percutaneously through a catheter delivery system, using venous access and transseptal puncture to enter the left atrium. Following implantation, patients receive anticoagulation with warfarin or alternative agents for approximately 1 to 2 months. After this period, patients are maintained on antiplatelet agents (ie, aspirin  and/or clopidogrel)

indefinitely. The Lariat Loop Applicator is a suture delivery device that is intended to close a variety of surgical wounds in addition to LAAC. The Cardioblate® closure device (Medtronic) is currently being tested in clinical studies. The Amplatzer cardiac plug (St. Jude Medical), is FDAapproved for closure of atrial septal defects but not for LAAC. A second-generation device, the Amplatzer Amulet, has been developed. The Percutaneous LAA Transcatheter Occlusion device (ev3) has also been evaluated in research studies but has not received FDA approval. The Occlutech® (Occlutech) Left Atrial Appendage Occluder has received a CE mark for coverage in Europe.

Outcome Measures

The optimal study design for evaluating the efficacy of percutaneous LAAC for the prevention of stroke in AF is a randomized controlled trial that includes clinically relevant measures of health outcomes. The rate of ischemic stroke during follow-up is the primary outcome of interest, along with rates of systemic embolization, cardiac events, bleeding complications, and death. For the LAAC devices, the appropriate comparison group could be oral anticoagulation, no therapy (for patients who have a prohibitive risk for oral anticoagulation), or open surgical repair.

Although the Watchman device and other LAAC devices would ideally represent an alternative to oral anticoagulation for the prevention of stroke in patients with AF, during the postimplantation period, the device may be associated with increased thrombogenicity and, therefore, anticoagulation is used during the periprocedural period. Most studies evaluating the Watchman device have included patients who are eligible for anticoagulation. Summary of Evidence

For individuals who have AF who are at increased risk for embolic stroke who receive the Watchman percutaneous LAAC device, the evidence includes 2 RCTs and meta-analyses of these trials. Relevant outcomes are overall survival, morbid events, and treatment-related morbidity.

The most relevant evidence comes from 2 industry-sponsored RCTs that compared the Watchman device with anticoagulation alone. One trial reported noninferiority on a composite outcome of stroke, cardiovascular/unexplained death, or systemic embolism after 2 years o follow-up, with continued benefits with the Watchman device after 4 years of follow-up.

The second trial did not demonstrate noninferiority for the same composite outcome but did demonstrate noninferiority of the Watchman device to warfarin for late ischemic stroke and systemic embolization. Patient-level meta-analyses at 5-year follow-up for the 2 trials reported that the Watchman device is noninferior to warfarin on the composite outcome of stroke, systemic embolism, and cardiovascular death. Also, the Watchman was associated with lower rates in major bleeding, particularly hemorrhagic stroke, and mortality over the long term. The evidence also indicates that the Watchman device is efficacious in preventing stroke in the subset of patients with AF who are at increased risk for embolic stroke. When it is determined on an individualized basis that the long-term risk of systemic anticoagulation exceeds the procedural risk of device implantation, the net health outcome will be improved. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have AF who are at increased risk for embolic stroke who receive a percutaneous LAAC device other than the Watchman device (eg, the Lariat or Amplatzer), the evidence includes uncontrolled case series. Relevant outcomes are overall survival, morbid events, and treatment-related morbidity. Case series of these devices have reported high procedural success, but also numerous complications. Also, these devices do not have Food and Drug Administration approval for LAAC. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this policy are listed in Table 3

Thursday, November 8, 2018

CPT code Prolotherapy therapy (proliferative therapy) - 20999


Introduction

Prolotherapy therapy (proliferative therapy) is a method to try to heal joints and connective  tissue. A solution is injected in the area. The solution irritates the tissue, causing inflammation.  This inflammation is supposed to stimulate the body’s natural healing response. These injections  are repeated over time. The hope is to gradually build up new issue in the injured area and  restore strength. Prolotherapy is investigational (unproven). The studies that have been done are  small and don’t show substantial improvement. There’s not enough medical evidence to show if  this technique works.

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 

Coding Code Description

CPT 20999 Unlisted procedure,  musculoskeletal system, general

HCPCS  Description

Prolotherapy  describes a procedure  intended for healing and strengthening ligaments and  tendons by injecting an agent that induces inflammation and stimulates endogenous repair  mechanisms.  Prolotherapy may also be referred to as proliferant injection, prolo, joint  sclerotherapy, regenerative injection therapy, growth factor stimulation injection, or nonsurgical  tendon, ligament, and joint reconstruction M0076 Prolotherapy

Background

The goal of prolotherapy is to promote tissue repair or growth by prompting release of growth  factors, such as cytokines, or by increasing the effectiveness of existing circulating growth  factors due to injection of an irritant solution. The mechanism of action is not well - understood  but may involve local irritation and/or cell lysis. Agents used with prolotherapy have included  zinc sulfate, psyllium seed oil, combinations of dextrose , glycerin , and phenol, or dextrose alone, often combined with a local anesthetic. Polidocanol and  sodium morrhuate, vascular sclerosants,  have also been used to sclerose areas of high intratendinous blood flow associated with  tendinopathies.  Prolotherapy typically involves multiple injections per session conducted over a  series of treatment sessions.

A similar treatment approach involves the injection of autologous platelet - rich plasma, which  contains a high concentration of platelet - derived growth factors.Treatment of musculoskeletal  pain conditions (eg, tendinopathies) with PRP is discussed in a sepa rate policy (see  Related  Policies ).

Summary of Evidence

For  individuals who have musculoskeletal pain (eg, chronic neck, back pain),  osteoarthritic pain,  or  tendinopathies of the upper or lower limbs includes ,the evidence includessmall randomized trials with inconsistent results. Relevant outcomes are symptoms, functional outcomes, and quality of life. The strongest evidence evaluates the use of prolotherapy for the treatment of  osteoarthritis, but the clinical significance of  the  therapeutic  results is  uncertain. The evidence is  insufficient to determine the effects of the technology on health outcomes

Practice Guidelines and Position Statements

American Association of Orthopaedic Medicine


The American Association of Orthopedic Medicine currently has a recommendation posted  online for the use of prolotherapy for back pain. The Association has indicated that “...prolotherapy should be considered a valid treatment option in a selected group of chronic low back pain patients.”Medicare National Coverage The Coverage Issues Manual #35 - 13 states that prolotherapy, joint sclerother apy, and  ligamentous injections with sclerosing agents are not covered, noting that the medical effectiveness of these therapies has not been verified by scientifically controlled studies. In 1999,  on request for reconsideration of coverage of prolotherapy for treatment for chronic low back pain, Medicare retained its noncoverage decision for prolotherapy, citing a lack of scientific  eviden ce on which to base a decision.

Regulatory Status

Sclerosing agents have been approved by the U.S. Food and Drug Administration for use in  treating spider and varicose veins. These sclerosing agents include Asclera® (polidocanol),  Varithena® (an injectable polidocanol foam), Sotradecol® (sodium tetradecyl sulfate), Ethamolin® (ethanolamine oleate), and Scleromate® (sodium morrhuate). These agents are not  currently approved as joint and ligamentous sclerosing agents

Wednesday, October 24, 2018

CPT CODE 0398T, 0071T, 0072T - Magnetic resonance procedure

Introduction

Magnetic resonance - guided  high - intensity ultrasound uses two technologies: magnetic  resonance imaging (MRI) and ultrasound. It is a noninvasive procedure, which means  the skin is  not cut .  MRI uses a magnetic field, radio frequency, and a computer to create detailed images of  organs, tissues, and bones. Ultrasound uses sound waves  at a higher frequency  than a person  can hear.  Ultrasound is usually used to create images of  body  structures to help diagnose  illnesses.  But in this treatment, the ultrasound beams are at a different frequency and are  focused on one area.  Heat is created at the point where the high frequency beams meet , and  the heat ablates ( destroys )  unhealthy tissue . The MRI is used to both guide the location of the  ultrasound beams and  to  monitor treatment. This policy discusses when magnetic resonance - guided high - intensity ultrasound ablation may be considered medically necessary and covered  by the health plan.

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.

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should  include the following:
* Documentation that the requested service is for pain control  that has failed  for patient  with bone  metastases, or not a candidate for radiotherapy
OR
* Documentation that patient has essential tremors not responding to medication (such as beta - blockers or anticonvulsants)

Coding Code Description CPT

0398T Magnetic resonance image guided high intensity focused ultrasound (MRgFUS),  stereotactic ablation lesion, intracranial for movement disorder including stereotactic  navigation  and frame placement when performed
0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total  leiomyomata volume of less than 200 cc of tissue
0072T Focused ultrasound ablation of uterine leiomyomata, including MR guidance;  total  leiomyomata volume greater or equal to 200 cc of tissue
53899 Unlisted procedure, urinary system
55899 Unlisted procedure, male genital system
76999 Unlisted ultrasound procedure (eg diagnostic, interventional

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).

Magnetic resonance - guided high - intensity ultrasound ablation of uterine fibroids is  specifically  identified by the following category III CPT codes:
* 0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total  leiomyomata volume of less than 200 cc of tissue
* 0072T As above, but with total leiomyomata volume great er or equal to 200 cc of tissue.

These CPT codes should not be used with 51702 (insertion of temporary indwelling bladder  catheter, simple) or 77022 (magnetic resonance imaging guidance for, and monitoring of,  visceral tissue ablation). Before the introduc tion of the specific category III CPT codes, the  procedure may have been coded using several codes describing the individual components of  the procedure. CPT codes 0071T - 0072T describe the comprehensive service.

The procedure may be performed in a magnetic resonance imaging suite with an open magnetic  resonance scanner, which might not be available at many institutions. The procedure is  performed in an outpatient setting, with the patient under conscious sedation. There are no specific CPT codes for the use of magnetic resonance - guided high - intensity  ultrasound ablation in metastatic bone cancer. An unlisted code would be used based on the  anatomic location of the metastasis being treated (eg, 23929 for the clavicle) or perhaps an  unlisted radiation oncology code (eg, 77299 or 77499)

Consideration of Age
Magnetic resonance*guided focused ultrasound (MRgFUS) is considered medically necessary for  bone metastases in adult patients, age 18 and older.
This is based on the randomized controlled  trial that studied the use of MRgFUS in  patients with  bone metatsase

Evidence Review Description
An integrated system providing magnetic resonance*guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids and pain palliation of bone  metastases. MRgFUS is also being investigated as a treatment of other benign and malignant  tumors.

Background
Uterine Fibroids

Uterine fibroids are one of the most common conditions affecting women in the reproductive  years. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain.

Treatment
Several approaches currently available to treat symptomatic uterine fibroids include: hysterectomy, abdominal myomectomy, laparoscopic and  hysteroscopic myomectomy,  hormone therapy, uterine artery embolization, and watchful waiting. Hysterectomy and various  myomectomy procedures are considered the  criterion standard treatment.

Metastatic Bone Disease
Metastatic bone disease is one of the most common causes of cancer pain.  Treatment Existing treatments include conservative measures ( eg, massage,  exercise) and pharmacologic  agents ( eg, analgesics, bisphosphonates, corticosteroids). For patients who  do not respond to  these treatments, standard care is external - beam radiotherapy. However, a substantial  proportion of patients have residual pain after radiotherapy, and there is a need for alternative
treatments for these patients.   One option, radiofrequency a blation, is addressed in a  related policy.

Essential Tremors
Essential tremor (ET) is the most common movement disorder, with an estimated prevalence of 5% worldwide. ET most often affects the hands and arms, may affect the head and voice, and rarely includes the face, legs, and trunk. ET is heterogeneous among patients, varying in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits

Treatment
The neuropathology of ET is uncertain, with some evidence suggesting that ET is localized in the  brainstem and cerebellum. If patients with ET experience intermittent or persistent disability due  to the tremors, initial therapy is with  drugs (*-blockersor anticonvulsants). For medicine-refractory patients, surgery (deep brain stimulation or thalamotomy) may be offered, though high rates of adverse events have been observed

Magnetic Resonance*Guided Focused Ultrasound
 
Magnetic resonance - guided focused ultrasound  ( MRgFUS ) is a noninvasive treatment that  combines  2  technologies : focused ultrasound and magnetic resonance imaging (MRI). The  ultrasound  beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. Ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. Ultrasound waves from each sonication are  directed  at a focal point that has a  maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid  rise in temperature (ie , to 65°C - 85°C), which is sufficient to  ablate  tissue at the focal point. In  addition to providing guidance, the associated MRI can provide online thermometric imaging, a  temperature “map” , to confirm the ther apeutic effect of the ablation treatment and allow for real - time adjustment of the treatment parameters

The U.S. Food and Drug Administration (FDA) has approved the ExAblate MRgFUS system (InSightec) for two indications : treatment of uterine fibroids (leiomyomata) and palliation of pain associated with tumors metastatic to bone. The ultrasound equipment is specially designed to be compatible with magnetic resonance magnets and is integrated into standard clinical MRI  units; it also includes a patient table, which  has  a cradle  that houses  the focused  ultrasound transducer in  water or  a  light oil bath. Some models have a detachable cradle; only certain  cradle types can be used for palliation of pain associated with metastatic bone  cancer. For  treating pain associated with bone metastases, the aim of MRgFUS is to destroy nerves in the  bone surface surrounding the tumor. MRgFUS is also being investigated for treatment of other tumors, including breast, prostate,  brain , and desmoid tumors as well as nonspinal osteoid osteoma.(For prostate cancer see Related Policy8.01.61 Focal Treatments for Prostate Cancer)

Summary of Evidence


For individuals who have uterine fibroids who receive MRgFUS, the evidence includes  2  small RCT s , nonrandomized comparative studies, and case series. Relevant outcomes are symptoms,  quality of life, resource utilization, and treatment - related morbidity.  One RCT (N=20)  has  reported some health outcomes, but its primary purpose was to determine the feasibility of a  larger trial. It did not find statistically significant differences in quality of life outcomes between  active and sham treatment groups, but it did find lower fibroid volumes after active treatment.  This trial  did not have an  active comparator , the clinical significance of the primary outcome was  unclear, and there were no follow - up data beyond 1 year.  The second RCT (N=49) is ongoing;  preliminary results at 6 weeks posttreatment, comparing MRgFUS with uterine artery  embolization  have shown that the 2 groups  are comparable in medication use and symptom  improvement following treatments. Patients in the MRgFUS group reported recovering  significantly faster than patients in the
uterine artery embolization  group, as measured by  time  to return to work and time to normal activities. In  a separate  2013 comparative study, outcomes  appeared to be better with uterine artery embolization than with MRgFUS.  Long - term data on  the treatment effects, recurrence rates, and impact on future fertility and pregnancy are lacking .  The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals  with  metastatic bone cancer who failed or are not candidates for radiotherapy who receive MRgFUS, the evidence includes a sham- controlled randomized trial and several case  series . Relevant outcomes are symptoms, functional outcomes, health status measures, quality  of life, and treatment - related morbidity. The RCT found statistically significant improvements after MRg FUS in a composite outcome comprised of reduction in pain and morphine use, and in  pain reduction as a stand - alone outcome. A substantial proportion of patients in the treatment  group experienced adverse events, but most  events were  transient and not severe.  The case  series reported reductions in pain following MRgFUS treatment, consistent with the RCT.  The  evidence is sufficient to determine that the technology results in a meaningful improvement in  the net health outcome

Friday, August 24, 2018

Basics of Dental Billing and vision care billing in APG payments


DENTAL BILLING:

Dental services provided in the clinic setting (hospital or free-standing) are to be billed using the APG payment methodology. The only exception to this policy is orthodonture, which is to be billed to the dental practitioner fee schedule and not to APGs. Orthodontic procedures are identified as those D codes grouping to APG 371 – Orthodontics. Again, APG 371 is a non-payable APG. Providers will continue to be required to obtain prior approval for orthodontic procedures. E&M codes should not be billed for any dental services. All dental services should be billed using only D codes Effective January 1, 2010, medical visits will no longer package with dental procedures or exams. When a patient has a medical visit (i.e., with a practitioner other than a dentist) and a dental visit on the same day, both the medical visit and the dental exam will pay at the line level.

Effective February 1, 2010, dental professional services are included in the APG payment to the facility and may not be billed by dentists using the Medicaid dental fee schedule. Specifically, no D codes (other than those used for orthodonture) are billable against the practitioner fee schedule. Dentists and/or oral surgeons should not bill Medicaid fee-for-service for non orthodontic D codes but may submit a claim for their professional services to the facility (i.e., the APG biller). If a practitioner is enrolled in Medicaid as both a dentist and a physician he/she may submit a separate [non-APG] professional claim for services payable off the physician schedule. If a procedure requires three encounters to complete, a clinic should claim for the applicable procedure code for each distinct date of service. However, APGs 373 Level I Dental Film, 374 Level II Dental Film, and 375 Dental Anesthesia will not pay if there are no other procedures claimed for the applicable date of service. For dates of service beginning January 1, 2009, when multiple dental procedures are performed on the same date of service, the highest weighted procedure will pay at 100% and all other dental procedures will be discounted (at 50%). This will be the case even for procedures that group to the same APG. Multiple same APG consolidation has been eliminated for dental services.

The procedure code for dental sealants (D1351), should be coded once for each tooth that is sealed on a single date of service. If four teeth are sealed during a visit, the code D1351 should appear on each of four claim lines, each with the same date of service. Beginning on January 1, 2011, dental sealants will become a units-based procedure, to be coded on only a single claim line – with the number of teeth sealed shown in the units field. The following are the dental ancillary procedure APGs: 373 Dental Film, 374 Level II Dental Film, 375 Dental Anesthesia, 376 Diagnostic Dental Procedures, and 377 Preventive Dental Procedures. All dental ancillaries pay at the line level. Multiple ancillaries that group to the same APG will be discounted by 50%, whereas multiple ancillaries that group to different APGs will be paid at 100%.

For APG dental billing the 837i claim format must be used, not the 837d claim form.

Dental code D9920 -- behavior management (for patients with mental retardation or a developmental disability) groups to APG 999 and will not pay under the APG reimbursement methodology.

Reimbursable services provided to recipients with recipient exception codes 81 or 95 will receive a 20% higher operating payment. This rate enhancement will begin July 1, 2010 for hospital clinics (using rate code 1501 for visit billing or 1489 for episode billing). Immediately upon the D&TCs transition to the APGs, and retroactive to September 1, 2009, free-standing clinics will receive the 20% rate enhancement for MR/DD/TBI patients under rate code 1435 (the MR/DD/TBI episode rate code 1425 is pended due to the lack of CMS approval of the Dec. 2009 D&TC State Plan Amendment).

Effective April 1, 2010, oral sedation in dentistry (D9248- Sedation (non-iv)) will be paid based on a procedure based weight. This code is to be used only for MR/DD/TBI recipients (as defined by recipient exception codes 81 or 95). Since there are currently no edits in place relative to this code, it is possible to improperly bill for this code. As with any violations of Medicaid billing policy, improper claims are subject to take back accompanied by possible legal action. Please check for the recipient eligibility prior to billing D9248.

VISION CARE BILLING:

Most vision care services are covered in the APG payment methodology. However two vision care services; “the fitting of spectacles: monofocal, bifocal, or multifocal” , “the fitting of spectacles and the eyeglass materials” are carved out of APGs and are billed using rate codes 1226 and 1227 respectively.

4.4 ANCILLARY LABORATORY SERVICES AND RADIOLOGY PROCEDURES: Under the new APG payment methodology, payment for laboratory and radiology services ordered by practitioners in hospital-based outpatient clinics is made to the clinic. When the hospital or D&TC patient receives the ancillary service from someone other than the clinic, the clinic is responsible for paying the individual or entity providing the ancillary service, even in the absence of a contractual relationship between the two parties. The ancillary service provider may not bill Medicaid directly for lab or the technical component of radiology services related to an APG-reimbursed visit and therefore must bill the ordering clinic for the service provided to clinic patients. This ancillary billing policy will be implemented prospectively in DTCs, effective January 1, 2011.

For example, when a practitioner in Clinic A orders a lab test or radiology service that it is not able to provide and the patient goes to Provider B (separate hospital, lab or a radiology group) to receive the service, Clinic A will be responsible for billing eMedNY for the ancillary service and making arrangements to pay Provider B for the delivery of the service. Clinic providers may wish to develop or revisit existing contractual arrangements with laboratory and radiology providers to ensure the availability of ancillary services for their patients and to avoid payment issues upon the implementation of the new APG payment methodology. This payment policy also applies to hospital ED units in the event that the ED physician orders an ancillary laboratory or radiology service that is provided to the patient subsequent to the ED visit.

Hospitals are and effective January 1, 2011 D&TCs will be responsible for advising outside lab and radiology service providers on the order for the service when the payment for the ancillary service is subject to APG reimbursement and the APG ancillary billing policy. They must also advise radiology service providers if they want the provider to “read” the radiology results and bill Medicaid directly for these professional services. Alternatively, if the hospital provider plans to bill for “reading” the radiology result, the hospital should advise the radiology vendor not to bill for the professional component of the radiology service. Only one professional component per radiology procedure per recipient may be billed to Medicaid.

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