Detailed overview of Health information technology

What Is Health IT? 

The  term  “health  information  technology”  (health  IT)  refers  to  the  electronic systems health care professionals – and increasingly, patients – use to store, share, and analyze health information. Health IT includes: 

▪ Electronic  health  records  (EHRs).  EHRs  allow  doctors  to  better  keep track of your health information and may enable them to see it when you have a problem even if their office is closed. EHRs also make it easier for your doctor to share information with specialists, so that specialists who need your information have it available when it’s needed. 

▪ Personal  health  records  (PHRs).  A  PHR  is  a  lot  like  an  EHR,  except  that  you  control  what  kind  of  information  goes  into  it.  You  can use a PHR to keep track of information from your doctor visits, but the PHR can also reflect your life outside the doctor’s office and your health priorities, such as tracking what you eat, how much you exercise, and your blood pressure. Sometimes, your PHR can link with your doctor’s EHR. 

▪ Electronic prescribing (E-prescribing). A paper prescription can get lost or misread. E-prescribing allows your doctor to communicate directly with your pharmacy. This means you can go to the pharmacy to pick up medicine without having to bring the paper prescription. 

▪ Privacy and security. All of these electronic systems can increase the protections of your health information. For example, electronic information  can  be  encrypted  so  that  only  authorized  people  can  read it. Health IT can also make it easier to record and track who has accessed your information. 

HEALTH INFORMATION TECHNOLOGY (HIT)

A. CCBHC providers must have HIT systems in place that:

1. Include Electronic Health Records (EHRs);

2. Capture demographic information, diagnoses and medications lists;

3. Provide clinical decision support;

4. Electronically transmit prescriptions to the pharmacy;

5. Allow reporting on data and quality measures required by the CCBHC program;

6. Allow the system to conduct activities such as population health management, quality improvement, disparity reduction, outreach and research; and

7. If the HIT is newly established, can also send and receive the full common data set for all summary of care records to support capabilities including transitions of care, privacy and security and to meet the Patient List Creation criterion (45 CFR 170.314(a)(14)) established by the Office of the National Coordinator (ONC) for ONC’s Health IT Certification Program.

QUALITY ASSURANCE

A. CCBHCs must have in place a HCQC approved written Continuous Quality Improvement (CQI) Plan. CCBHCs must:

1. Comply with this plan and all other HCQC requirements to ensure on-going quality care;

2. Ensure the plan includes a description of how the public is made aware of the availability of CCBHC services;

3. Submit all required and requested data, quality and fidelity measures reports to comply with the requirements of the CCBHC program timely; and

4. Provide oversight and monitoring of all their DCOs to ensure services provided meet the requirements of the CQI plan; they are enrolled as an Ordering,

PROVIDER QUALIFICATIONS

A. CCBHC services are provided by qualified individuals in an interdisciplinary treatment team approach. The CCBHC treatment team is comprised of individuals who meet the qualifications of direct care providers under the relevant MSM chapter and who collaborate to provide and coordinate medical, psychosocial, emotional, therapeutic and recovery support services to the recipients served. All direct care providers of CCBHC services must be able to provide services under the CCBHC delivery model and meet the qualification as specified in the relevant MSM chapter.

B. CCBHCs must also ensure all DCO providers are qualified and compliant with the requirements of the CCBHC program, this chapter and all relevant MSM Chapters and the Addendum.

TARGET POPULATIONS

The CCBHC target populations are the primary populations of focus. These groups include: COD, Seriously Emotionally Disturbed (SED)/Non-SED, Severely Mentally Ill (SMI)/Non-SMI and

SUD. SED/Non-SED and SMI/Non-SMI are defined in the MSM Addendum. COD and SUD are defined above.

 RECIPIENT ELIGIBILITY

A. Admission Criteria: To be eligible for CCBHC services, a recipient must meet criteria for one of the six target groups.

B. Continuing Stay Criteria: The recipient continues to meet admission criteria and needs restoration for the best possible functioning or is at risk of relapse and a higher level of care.

C. Discharge Criteria: The recipient no longer meets admission and continuing stay criteria; no longer wishes to receive services; or their care has been transferred, the discharge summary has been provided and the coordination of care has been completed with the new provider.

Health IT covers following areas; 

1.EMR/EHR/PHR all are one and same with little difference 2.Telemedicine 3.Digital health knowledge resource e.g. Digital Medical Library 4.Hospital Information management system 5.e-learning technologies and application in health Science 6.Biomedical informatics for biomedical research applications 7.Artificial Intelligence in clinical medicine and health management 8.Public health informatics 9.Medical Internet 10.Virtual Reality and Simulation for health

cpt 33477 - Transcatheter Pulmonary Valve Implantation

Coding Code Description CPT


33477 Transcatheter pulmonary valve implantation, percutaneous approach, including prestenting of the valve delivery site, when performed




Transcatheter Pulmonary Valve Implantation


Introduction

Congenital heart disease is a term that means a person was born with heart problems. These difficulties affect the heart’s function and structure. Congenital heart disease can range from mild, which may not need treatment, to severe, which often does. One congenital heart defect is known as right ventricular outflow tract (RVOT) dysfunction. Essentially, it’s a problem with how the blood flows as it leaves the heart and goes to the lungs. Repairing it requires reconstructing certain areas of the heart and placing a tube (conduit) to allow the blood to flow correctly. Over a long period of time the conduit can become narrowed or a specific valve can become leaky. A second valve replacement surgery may be needed in this situation. This second surgery is usually done as an open surgery. However, surgery using a long, thin tube (a heart catheter) instead of open heart surgery can be done in certain situations. This policy describes when an additional RVOT surgery using a catheter may be considered medically necessary.


Transcatheter pulmonary valve implantation (TPVI)

Transcatheter pulmonary valve implantation is considered medically necessary for patients with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:
* Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation OR
* Individuals with native or patched RVOT with at least moderate pulmonic regurgitation OR
* Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis  (mean RVOT gradient at least 35 mm Hg) OR
* Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg). Transcatheter pulmonary valve implantation is considered investigational for all other indications.


Evidence Review Description

Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to open surgical pulmonary valve replacement or reconstruction for right ventricular outflow tract (RVOT) obstruction. Percutaneous pulmonary valve replacement may be indicated for congenital pulmonary stenosis. Pulmonary stenosis or regurgitation in a patient with congenital heart disease (CHD) who has previously undergone RVOT surgery are additional indications. Patients with prior CHD repair are at risk of needing repeated reconstruction procedures.

Background

Congenital Heart Disease

Congenital heart disease, including tetralogy of Fallot, pulmonary atresia, and transposition of the great arteries, is generally treated by surgical repair at an early age. This involves reconstruction of the right ventricular outflow tract (RVOT) and pulmonary valve using a surgical homograft or a bovine-derived valved conduit. These repairs are prone to development of pulmonary stenosis or regurgitation over long periods of follow-up.

Because individuals with surgically corrected congenital heart disease are living into adulthood, RVOT dysfunction following initial repair has become more common. Calcification of the RVOT conduit can lead to pulmonary stenosis, while aneurysmal dilatation can result in pulmonary regurgitation. RVOT dysfunction can lead to decreased exercise tolerance, potentially fatal arrhythmias, and/or irreversible right ventricular dysfunction.1

Treatment

Interventions for RVOT dysfunction often require numerous repeat open heart procedures for patients who live into adulthood. Treatment options for pulmonary stenosis are open surgery with valve replacement, balloon dilatation, or percutaneous stenting.1 Interventions for pulmonary regurgitation are primarily surgical, either reconstruction of the RVOT conduit or replacement of the pulmonary valve. The optimal timing of these interventions is not well understood.2

Transcatheter pulmonary valve replacement offers a less invasive treatment option for patients with prior surgery for congenital heart disease and RVOT dysfunction. It is possible that a less invasive valve replacement technique could spare patients from multiple repeat open heart procedures over long periods of follow-up.

Summary of Evidence

For individuals who have a history of congenital heart disease (CHD) and current right  ventricular outflow tract (RVOT) obstruction who receive transcatheter pulmonary valveimplantation (TPVI) with a Food and Drug Administration (FDA)-approved device and indication, the evidence includes prospective, interventional, noncomparative studies and multiple prospective and retrospective case or cohort series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. Results of the case series have indicated that there is a high rate of procedural success and low procedural mortality, although the rates of serious procedural adverse events reported ranges from 3.0% to 7.4%. Most valves have demonstrated competent functioning by Doppler echocardiography at 6- to 12-month follow-ups, but complications (eg, stent fractures, need for re-interventions) were reported in an FDA analysis to occur at rates of 18% and 7%, respectively. Other publications with longer follow-up have reported stent fractures in up to 26% of patients; however, most stent fractures did not required reintervention. Studies with follow-up extending to a maximum of 7 years postprocedure have suggested that the functional and hemodynamic improvements are durable, but a relatively high proportion of patients (20%-30%) have required reintervention on the pulmonary valve. No comparative studies were identified, and there is no direct evidence that TPVI reduces future open heart procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have a history of CHD and current RVOT obstruction who receive TPVI with a non-FDA-approved device or indication, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity and mortality. There is limited evidence on the off-label use of TPVI, including the use of a non-FDA-approved valve, or use of an approved valve for a non-FDAapproved indication. The published case series enrolled relatively few patients and are heterogeneous regarding devices used and indications for TPVI. The evidence is insufficient to determine the effects of the technology on health outcomes.

CPT 0195T, 0309T, 22586, 22899 - Lumbosacral Interbody Fusion

Coding Code Description CPT

0195T Arthrodesis, pre-sacral interbody technique, disc space preparation, discectomy, without instrumentation, with image guidance, includes bone graft when performed;

L5-S1 interspace
0196T Arthrodesis, pre-sacral interbody technique, disc space preparation, discectomy, without instrumentation, with image guidance, includes bone graft when performed;

L4-L5 interspace (List separately in addition to code for primary procedure)

0309T Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft, when performed, lumbar, L4-L5 interspace (List separately in addition to code for primary procedure) (code terminated 1/1/18, replaced with 22899)

22586 Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, L5-S1 interspace.

22899 Unlisted procedure, spine


Lumbosacral Interbody Fusion



Introduction

Fusing the bones at the lowest part of the back may be one choice to treat lower back (lumbar) pain. When this kind of fusion is needed, it’s usually done by making an opening (an incision) through the back muscles and other tissue. In axial lumbar interbody fusion, the incision is made in the buttock. A tube, long enough to reach the spine, is inserted upwards along a specific path. Special tools are then threaded through the tube to reach the disc that sits between the bones.

The surgeon cuts way the damaged disk and removes it through the tube. The tube also guides the path for the bone graft material and a small implant. The bone graft material promotes bone growth, and over time the two bones grow together and are permanently joined. Because more studies are needed to determine the risks and benefits of this procedure compared to other methods of lumbar fusion, this service is considered unproven (investigational).

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 Axial lumbosacral interbody fusion

Axial lumbosacral interbody fusion is considered investigational.


Evidence Review Description

Axial lumbosacral interbody fusion (LIF; also called presacral, transsacral or paracoccygeal interbody fusion) is a minimally invasive technique designed to provide anterior access to the L4-S1 disc spaces for interbody fusion, while minimizing damage to muscular, ligamentous, neural, and vascular structures. It is performed under fluoroscopic guidance.

Background

Interbody fusion is a surgical procedure that fuses 2 adjacent vertebral bodies of the spine. Lumbar interbody fusion may be performed in patients with spinal stenosis and instability, spondylolisthesis, scoliosis, following discectomy, or for adjacent-level disc disease.

Axial Lumbosacral Interbody Fusion

The procedure for 1-level axial LIF is as follows1: Under fluoroscopic monitoring, a blunt guide pin introducer is passed through a 15-mm to 20-mm incision lateral to the coccyx and advanced along the midline of the anterior surface of the sacrum. A guide pin is introduced and tapped into the sacrum. A series of graduated dilators are advanced over the guide pin, and a dilator sheath attached to the last dilator is left in place to serve as a working channel for the passage of instruments. A cannulated drill is passed over the guide pin into the L5-S1 disc space to rest on the inferior endplate of L5. It is followed by cutters alternating with tissue extractors, and the nucleus pulposus is debulked under fluoroscopic guidance. Next, bone graft material is injected to fill the disc space. The threaded rod is placed over the guide pin and advanced through the sacrum into L5. The implant is designed to distract the vertebral bodies and restore disc and neural foramen height. The additional graft material is injected into the rod, where it enters into the disc space through holes in the axial rod. A rod plug is then inserted to fill the cannulation of the axial rod. Percutaneous placement of pedicle or facet screws may be used to provide supplemental fixation.

An advantage of axial LIF is that it allows preservation of the annulus and all paraspinous soft tissue structures. However, there is an increased need for fluoroscopy and an inability to address intracanal pathology or visualize the discectomy procedure directly. Complications of the axial approach may include perforation of the bowel and injury to blood vessels and/or nerves.

Summary of Evidence

For individuals with degenerative spine disease at the L4- S1 disc spaces who receive axial LIF the evidence includes comparative systematic review of case series and a retrospective comparative study. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review found that fusion rates were higher following transforaminal LIF than following axial LIF, although this difference decreased with use of bone morphogenetic protein or pedicle screws. The findings of this systematic review were limited by the lack of prospective comparative studies and differences in how fusion rates were determined. Studies suggest that complication rates may also be increased with 2-level axial LIF. Controlled trials with clinical outcome measures are needed to better define the benefits and risks of this procedure compared with treatment alternatives. The evidence is insufficient to determine the effects of the technology on health outcomes.


Clinical Input Received from Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In response to requests, input was received from 2 specialty medical societies and 3 academic medical centers while this policy was under review in 2011. The input considered axial LIF to be investigational.

Practice Guidelines and Position Statements

North American Spine Society
The North American Spine Society published guidelines on the treatment of degenerative spondylolisthesis in 2014.12 The Society gave a grade B recommendation for surgical decompression with fusion in patients with spinal stenosis and spondylolisthesis. The guideline discussed posterolateral fusion, 360° fusion, and minimally invasive fusion; it did not address axial lumbosacral interbody fusion.

American Association of Neurological Surgeons

The American Association of Neurological Surgeons published guidelines for interbody techniques for lumbar fusion in 2005 (part 11).13 There was insufficient evidence to recommend a treatment standard. Minimally invasive procedures were not reviewed.

National Institute for Health and Clinical Excellence

The National Institute for Health and Clinical Excellence provided guidance on transaxial interbody fusion in the lumbar spine in 2011.14 The guidance stated that current evidence on the efficacy of transaxial interbody lumbosacral fusion is “limited in quantity but shows symptom relief in the short term in some patients. Evidence on safety shows that there is a risk of rectal perforation.” The Institute encouraged “further research into transaxial interbody lumbosacral fusion. Research outcomes should include fusion rates, pain and functional scores, quality-of-life measures, and the frequency of both early and late complications.”

CPT code 31660, 31661 - Bronchial Thermoplasty

Coding Code Description CPT

31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe

31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes


Bronchial Thermoplasty


Introduction

Asthma is a long-term lung condition causing the airways of the lung to become inflamed. Inhaling certain substances such as tobacco smoke, pet dander, and dust mites can set off a chain reaction. One thing that happens during this chain reaction is that muscles around the airways constrict (tighten). This makes the airways narrower, which means less air gets into the lungs. This results in wheezing, tightness in the chest, coughing, and shortness of breath. Bronchial thermoplasty is one proposed treatment for asthma. The idea is that if there was less smooth muscle tissue around the airways, there would also be less airway constriction and fewer asthma attacks. Heat, delivered through an instrument known as a bronchoscope, is used to destroy the smooth muscle tissue. Bronchial thermoplasty is investigational (unproven). There are no long-term studies to show how well this treatment works. Longer studies are needed to see if it’s safe and effective.

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.


Service Investigational Bronchial thermoplasty Bronchial thermoplasty for the treatment of asthma is considered investigational.



Evidence Review Description

Bronchial thermoplasty is a potential treatment option for patients with severe persistent asthma. It consists of radiofrequency energy delivered to the distal airways, with the aim of decreasing smooth muscle mass believed to be associated with airway inflammation.


Background Asthma

Asthma, a chronic lung disease, affects approximately 8.3% of adults and 8.3% of children in the United States and, in 2017, accounted for approximately 1.7 million emergency department visits and 3615 deaths.1 Asthma symptoms include episodic shortness of breath that is generally  associated with other symptoms such as wheezing, coughing, and chest tightness. Objective clinical features include bronchial hyperresponsiveness, airway inflammation, and reversible airflow obstruction (at least 12% improvement in forced expiratory volume in 1 second postbronchodilator, with a minimum of 200 mL improvement). However, there is substantial heterogeneity in the inflammatory features of patients diagnosed with asthma, and this biologic diversity is responsible, at least in part, for the variable response to treatment in the asthma population.

Management

Management of asthma consists of environmental control, patient education, management of comorbidities, and regular follow-up for all affected patients, as well as a stepped approach to medication treatment. Guidelines from the National Heart, Lung and Blood Institute have defined 6 pharmacologic steps: step 1 for intermittent asthma and steps 2 through 6 for persistent asthma.2 The preferred daily medications: step 1: short-acting ?-agonists as-needed;
step 2: low-dose inhaled corticosteroids (ICS); step 3: ICS and long-acting ?-agonists (LABA) or medium-dose ICS; step 4: medium-dose ICS and LABA; step 5: high-dose ICS and LABA; and
step 6: high-dose ICS and LABA, and oral corticosteroids.

Despite this multidimensional approach, many patients continue to experience considerable morbidity. In addition to ongoing efforts to implement optimally standard approaches to asthma treatment, new therapies are being developed. One recently developed therapy is bronchial thermoplasty, the controlled delivery of radiofrequency energy to the heat tissues in the distal airways. Bronchial thermoplasty is based on the premise that patients with asthma have an increased amount of smooth muscle in their airways and that contraction of this smooth muscle is a major cause of airway constriction. The thermal energy delivered via bronchial thermoplasty aims to reduce the amount of smooth muscle and thereby decrease musclemediated bronchoconstriction with the ultimate goal of reducing asthma-related morbidity. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma (ie, steps 5 and 6 in the stepwise approach to care).


Bronchial thermoplasty procedures are performed on an outpatient basis, and each session lasts approximately 1 hour. During the procedure, a standard flexible bronchoscope is placed through the patient’s mouth or nose into the most distal targeted airway, and a catheter is inserted into the working channel of the bronchoscope. After placement, the electrode array in the top of the catheter is expanded, and radiofrequency energy is delivered from a proprietary controller and used to heat tissue to 65?C over a 5mm area. The positioning of the catheter and application of thermal energy is repeated several times in contiguous areas along the accessible length of the airway. At the end of the treatment session, the catheter and bronchoscope are removed. A course of treatment consists of 3 separate procedures in different regions of the lung scheduled about 3 weeks apart.

Summary of Evidence

For individuals who have asthma refractory to standard treatment who receive bronchial thermoplasty added to medical management, the evidence includes 3 RCTs and observational studies. Relevant outcomes are symptoms, quality of life, hospitalizations, and treatment-related morbidity. Early studies (RISA, AIR) investigated safety outcomes, finding similar rates of adverse events and exacerbations between the bronchial thermoplasty and control groups. These trials were limited by their lack of sham control. The AIR2 trial is the largest of the 3 published RCTs, and the only one double-blinded and sham-controlled, with sites in the United States. Over 1 year, bronchial thermoplasty was not found to be superior to sham treatment on the investigator-designated primary efficacy outcome of mean change in the quality of life score but was found to be superior on a related outcome, improvement in the quality of life of at least 0.5 points on the AQLQ. There was a high response rate in the sham group of the AIR2 trial, suggesting a large placebo effect, particularly for subjective outcomes such as quality of life.

There are no long-term sham-controlled efficacy data. Findings on adverse events from the 3 trials have suggested that bronchial thermoplasty is associated with a relatively high rate of adverse events, including hospitalizations during the treatment period, but not in the posttreatment period. Safety data up to 5 years have been reported in the RCTs for patients treated with bronchial thermoplasty but not for control patients. Safety data from a U.K. registry study, published in 2016, found that 20% of bronchial thermoplasty procedures were associated with a safety event (ie, procedural complications, emergency respiratory readmissions, emergency department visits, and/or postprocedure overnight stays). Conclusions cannot be drawn about the effect of bronchial thermoplasty on the net health outcome due to the limited amount of sham controlled data (1 RCT) on short-term efficacy, the uncertain degree of treatment benefit in that single sham-controlled trial, the lack of long-term sham controlled data in the face of a high initial placebo response, and the presence of substantial adverse events. Also, there is a lack of data on patient selection factors for   this procedure and, as a result, it is not possible to determine whether there are patient subgroups that might benefit. The evidence is insufficient to determinethe effects of the technology on health outcomes.

CPT 61885, 61886, 64553 - 54570 - L8679 - L8689

Coding Code Description CPT

61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays
64553 Percutaneous implantation of neurostimulator electrodes; cranial nerve
64568 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator
64569 Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator
64570 Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator

HCPCS

L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
L8682 Implantable neurostimulator radiofrequency receiver
L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes
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
L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only
L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only


Occipital Nerve Stimulation

Introduction
The occipital nerves run through the muscles on the back of the head and over the scalp. Irritation to these nerves can create shooting or tingling pain, usually on one side of the head or near one eye. The scalp can also can be very painful to the touch. Occipital nerve stimulation is a being studied as a technique for migraines and other headaches that don’t respond to medication. Occipital nerve stimulation aims to treat pain with electrical signals. Wires are implanted at the base of the skull. The wires are connected to a small power source surgically placed below the skin, usually in the upper chest. The power source generates the electricity, which then sends the signal through the wires to stimulate the occipital nerve. It’s thought that the electrical signals block or scramble the pain signals from the nerves. Because more studies are needed to see if this technique is effective, occipital nerve stimulation is considered investigational (unproven).

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 Occipital nerve stimulation Occipital nerve stimulation is considered investigational for all indications.



Evidence Review Description

Occipital nerve stimulation delivers a small electrical charge to the occipital nerve in an attempt to prevent migraines and other headaches in patients who have not responded to medications.

The device consists of a subcutaneously implanted pulse generator (in the chest wall or abdomen) attached to extension leads that are tunneled to join electrodes placed across one or both occipital nerves at the base of the skull. Continuous or intermittent stimulation may be used.

Background Headache

There are 4 types of headache: vascular, muscle contraction (tension), traction, andinflammatory. Primary (not the result of another condition) chronic headache is defined as headache occurring more than 15 days of the month for at least 3 months. An estimated 45 million Americans experience chronic headaches. For at least half of these people, the problem is severe and sometimes disabling. Herein, we only discuss types of vascular headache, including migraine, hemicrania continua, and cluster.

Migraine

Migraine is the most common type of vascular headache. Migraine headaches are usually characterized by severe pain on one or both sides of the head, an upset stomach, and, at times, disturbed vision. One-year prevalence of migraine ranges from 6% to 15% in adult men and from 14% to 35% in adult women. Migraine headaches may last a day or more and can strike as often as several times a week or as rarely as once every few years.

Treatment

Drug therapy for migraine is often combined with biofeedback and relaxation training. Sumatriptan is commonly used for relief of symptoms. Drugs used to prevent migraine include amitriptyline, propranolol and other ß-blockers, topiramate and other antiepileptic drugs, and verapamil.

Hemicrania Continua

Hemicrania continua causes moderate pain with occasionally severe pain on only one side of the head. At least one of the following symptoms must also occur; conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, or ptosis and/or miosis. Headache occurs daily and is continuous with no pain-free periods. Hemicrania continua occur mainly in women, and its true prevalence is not known.


Treatment

Indomethacin usually provides rapid relief of symptoms. Other nonsteroidal anti-inflammatory drugs, including ibuprofen, celecoxib, and naproxen, can provide some relief from symptoms. Amitriptyline and other tricyclic antidepressants are effective in some patients.

Cluster Headache

Cluster headache occurs in cyclical patterns or clusters of severe or very severe unilateral orbital  or supraorbital and/or temporal pain. The headache is accompanied by at least one of thefollowing autonomic symptoms: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of 1 headache every other day up to 8 attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies by person, but most people have 1 or 2 cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is common in men than in woman. One-year prevalence is estimated to be 0.5 to 1.0 in 1000.

Treatment

Management of cluster headache consists of abortive and preventive treatment. Abortive treatments include subcutaneous injection of sumatriptan, topical anesthetics sprayed into the nasal cavity, and strong coffee. Some patients respond to rapidly inhaled pure oxygen. A variety of other pharmacologic and behavioral methods of aborting and preventing attacks have been reported with wide variation in patient response.
Peripheral Nerve Stimulators

Implanted peripheral nerve stimulators have been used to treat refractory pain for many years, but have only recently been proposed to manage craniofacial pain. Occipital, supraorbital, and infraorbital stimulation have been reported in the literature.


Summary of Evidence

For individuals with migraine headaches refractory to preventive medical management who receive occipital nerve stimulation, the evidence includes randomized controlled trials (RCTs), a systematic review of RCTs, and observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Systematic review identified 5 sham-controlled RCTs. Findings from pooled analyses of these RCTs were mixed. For example, compared to placebo, response rates to occipital nerve stimulation did not differ significantly but did reduce the number of days with prolonged moderate-to-severe headache. Occipital nerve stimulation was also associated with a substantial number of minor and serious adverse events. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have non-migraine headaches (eg, hemicrania continua, cluster headaches) who receive occipital nerve stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many of the case series had small sample sizes; series with over 25 patients were available only for treatment of cluster headache. Although the case series tended to find that a substantial number of patients improved after occipital nerve stimulation, these studies lacked blinding and comparison groups. RCTs are needed to compare outcomes between occipital nerve stimulation and comparators (eg, to control for a potential placebo effect). The evidence is insufficient to determine the effects of the technology on health outcomes.

HOSPITAL-GRADE ELECTRIC BREAST PUMP - Medicaid Guide

Definition A hospital grade electric breast pump is heavy duty, piston-operated, and is capable of being used frequently on a daily basis.

Standards of Coverage

A hospital grade electric breast pump may only be covered for a beneficiary with a Neonatal Intensive Care Unit (NICU) infant, up to three months of age, when one of the following applies:

* The infant has a severe feeding problem secondary to cleft lip and/or palate.

* The infant has a severe feeding problem due to oral motor dysfunction, secondary to prematurity.

* The infant is hospitalized resulting in a physical separation of the mother and infant.

* The infant or mother is hospitalized, resulting in a physical separation of the mother and infant; and all of the following applies:

* The pump has an adjustable suction pressure at the breast shield during use between 30 mm Hg and 250 mm Hg (suction just at the low or high end is not acceptable);

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma;

* The pump has an adjustable/varying pumping speed no less than 30 cycles per minute and capable of reaching up to a maximum of 60 cycles per minute;

* The pump must be able to operate on a 110-volt household current and be UL listed;

* The pump must not weigh over 12 pounds; and

* The pump is registered and cleared with the FDA.

For continued coverage beyond the initial three months, additional documentation must be provided.

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

* Diagnosis/medical condition of the infant relating to the need for a breast pump.

* Infant's age (gestational age, if premature).

* Mother's discharge date.

* Anticipated duration of need.

* An order signed by the treating physician or non-physician practitioner.

* The International Classification of Diseases (ICD) diagnosis code(s) related to birth or pregnancy.

* Documentation of mother’s intent to breastfeed.

Documentation must be kept in the beneficiary’s file and made available upon request.

PA Requirements PA is not required when the Standards of Coverage are met.


PA is required for coverage beyond three months

Payment Rules A breast pump is considered a rental only item and is inclusive of the following:

* All related accessories necessary to use the equipment. (To obtain additional reimbursement for the initial breast pump kit, report the "KH" modifier with HCPCS code E0604 for the first month of rental only.)

* Education on the proper use and care of the equipment.

* Routine servicing and all necessary repairs or replacements to make the unit functional.

The rental pump may be billed using the infant's Medicaid ID number if the need for the hospital grade pump meets the standards of coverage and the mother loses Medicaid eligibility.

Rental of the hospital-grade electric breast pump will not be made if a personal use double electric breast pump or a manual breast pump was purchased for the beneficiary within the Standards of Coverage frequency limitations.


PERSONAL USE DOUBLE ELECTRIC BREAST PUMP

Definition A personal use double electric breast pump is defined as a double electric (AC and/or DC) pump, intended for a single user, capable of being used frequently on a daily basis.

Standards of Coverage

A personal use double electric breast pump may be covered once per five years for a beneficiary when all of the following criteria are met:

* The mother expresses the desire to breastfeed;

* The pump has been registered and cleared by the FDA;

* The pump has a minimum of a one-year manufacturer’s warranty;

* The pump has an adjustable suction pressure at the breast shield during use between 30 mm Hg and 250 mm Hg (suction just at the low or high end is not acceptable);

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma;

* The pump has an adjustable/varying pumping speed no less than 30 cycles per minute and capable of reaching up to a maximum of 60 cycles per minute;

* The pump must be able to operate on a 110-volt household current and be UL listed;

* The pump must not weigh over 12 pounds; and

* The pump collection bottle must be bisphenol-A (BPA) and DHEP-free.



Documentation Must be less than 30 days old and include all of the following:

* An order signed by the treating physician or non-physician practitioner.

* The International Classification of Diseases (ICD) diagnosis code(s) related to birth or pregnancy.

* Infant’s age (gestational age, if premature).

* Mother’s hospital discharge date or infant’s hospital discharge date.

* Documentation of mother’s intent to breastfeed.

Documentation must be kept in the beneficiary’s file and made available upon request. PA Requirements PA is not required when the Standards of Coverage are met. PA is required for circumstances beyond the Standards of Coverage and Payment Rules.

Payment Rules All personal use double electric breast pumps are purchase only. Payment includes:

* Education for the proper use, care of the equipment, and storage of breast milk.

* Supplies necessary for operation of the pump (pump, adapter/charger, breast shields, bottles, lids, tubing, locking ring, connectors, valves, filters and membranes.

The pump may be billed using the infant’s Medicaid ID number if the need for the pump meets the Standards of Coverage and the mother loses Medicaid eligibility. Medicaid will not purchase a personal use double electric breast pump during the rental period of a hospital-grade electric breast pump or if a manual breast pump was purchased within the Standards of Coverage frequency limitations.

Replacement parts are covered after the manufacturer’s warranty has expired for included parts. Refer to the Medical Supplier database and the Medicaid Code and Rate Reference tool for covered replacement parts, code descriptions, coverage limitations and reimbursement.

 MANUAL BREAST PUMP

Definition A manual breast pump typically consists of a single breast shield, a collection device, and a hand-controlled lever to create suction and express milk. Manual breast pumps are intended for a single user.


Standards of Coverage

A manual breast pump may be covered once per birth. For a beneficiary who has had a multiple birth delivery, only one pump is covered. Coverage of a manual breast pump may be provided when all of the following criteria have been met:

* The mother expresses the desire to breastfeed.

* The pump has been registered with the FDA.

* The pump has a minimum of a one year manufacturer’s warranty.

* The pump has a mechanism to prevent suction beyond 250 mm Hg to prevent nipple trauma.

* The pump collection bottle must be bisphenol-A (BPA) and DHEP-free.


Definition Diabetic shoes, inserts and related modifications include, but are not limited to, depth inlay shoes, multi-density inserts, roller or rocker bottoms, wedges, metatarsal bar, and offset heel.


Standards of Coverage

Diabetic shoes, inserts, and/or modifications may be covered for individuals who have, due to complications with diabetes mellitus, one of the following conditions:

* History of previous foot ulcerations or pre-ulcerative calluses.

* Established peripheral neuropathy or sensory impairment.

* Peripheral Vascular Disease with an ankle brachial index at rest of 0.5 or less following exercise.

* Loss of a toe or portion of the foot due to amputation arising from diabetes.

A custom-molded diabetic shoe is covered only if the depth shoe cannot accommodate a foot anomaly.

Inserts are covered if the beneficiary requires a depth shoe or custom-molded diabetic shoe. For a depth shoe, three inserts would be separately reimbursable in addition to the noncustomized one included with the shoe. For a custom-molded shoe, two inserts would be separately reimbursable. Modifications to a custom-molded or depth shoe may be covered rather than an additional insert.


Documentation Documentation must be less than 30 days old and include all of the following:

* Diagnosis/medical condition related to the service requested.

* Medical reasons for specific shoe type and/or modification.

PA Requirements PA is not required for the following inserts if the Standards of Coverage are met:

* Multiple density insert, direct formed, molded to foot with external heat source.

* Multiple density insert, direct formed, compression molded to patient's foot without external heat source.

* Multiple density insert, custom fabricated and custom-molded from model of patient's foot.

* Depth inlay shoes.

* Modifications if an additional insert is not provided.



PA is required for:

* Medical need beyond the Standards of Coverage.

* Replacement within one year.

* Quantity beyond established limits.

* Custom-fabricated shoes and other inserts not included above. Payment Rules All items are considered purchase only.

Which provider can bill Daily care, ANCILLARY PHYSICAL AND OCCUPATIONAL THERAPY, SPEECH PATHOLOGY

DAILY CARE

The following providers may bill for daily care and must enter the appropriate revenue code that identifies the specific daily care accommodation being billed:

* Nursing Home Facilities

* County Medical Care Facilities

* Hospital Long Term Care Units

* Hospital Swing Beds

* Ventilator Dependent Units

The NUBC Manual provides the revenue codes to be used for Michigan Medicaid.



ANCILLARY PHYSICAL AND OCCUPATIONAL THERAPY, SPEECH PATHOLOGY

The following providers may bill physical/occupational therapy and speech pathology:

* Nursing Home Facilities

* County Medical Care Facilities

* Hospital Long Term Care Units

* Outpatient County Medical Care Facilities

When billing on the NUBC claim form, facilities must use the revenue codes and HCPCS codes identified on the MDHHS Therapy Services Database available on the MDHHS website. (Refer to the Directory Appendix for website information.)

* Each ancillary service must be billed on a separate claim line. Series billing is not allowed.

* Each claim line requires a:

* Date of service

* Revenue code and a HCPCS code

* PA number on the claim

Dual-use therapy codes may be billed by a physical therapist and an occupational therapist on the same date of service when both professionals provide covered therapy services on the same day under their corresponding treatment plans. The codes are identified on the MDHHS Therapy Services Database with required modifiers GO and GP. The appropriate modifier must always be used on the claim line to avoid a claim rejection when billing a dual-use code.

* Occupational therapy modifier: GO

* Physical therapy modifier: GP


OUTPATIENT COUNTY MEDICAL CARE FACILITIES

* When billing for therapies, outpatient county medical care facilities must indicate the Type of Bill as 23X.

* Each service must be billed on a separate claim line. Series billing is not allowed.

* Each claim line requires a revenue code and a CPT/HCPCS code.

* Each claim requires a PA number to be reported in the appropriate form locator or electronic segment.