Pacemakers are intended to be used as a substitute for the heart’s intrinsic pacing system to correct cardiac rhythm disorders. Conventional pacemakers consist of 2 components: a pulse generator and electrodes (or leads). Pacemakers are considered life-sustaining, life-supporting class III devices for individuals with a variety of bradyarrhythmias. Even though the efficacy and safety profile of conventional pacemakers are excellent, in a small proportion of individuals , they may result in lead complications and the requirement for a surgical pocket. Further, some individuals are medically ineligible for conventional pacemakers due to lack of venous access and recurrent infection. Leadless pacemakers are single-unit devices that are implanted in the heart via femoral access, thereby eliminating the potential for complications as a result of leads and surgical pocket. The Micra and Aveir single-chamber transcatheter pacing systems and the Aveir dual-chamber pacing system are the only commercially available leadless pacemakers in the U.S. approved by the U.S. Food and Drug Administration.

Central sleep apnea (CSA) is characterized by sleep-disordered breathing due to diminished or absent respiratory effort. Central sleep apnea may be idiopathic or secondary (associated with a medical condition, drugs, or high altitude breathing). The use of positive airway pressure devices is currently the most common form of therapy for CSA. An implantable device that stimulates the phrenic nerve in the chest is a potential alternative treatment. The battery-powered device sends signals to the diaphragm in order to stimulate breathing and normalize sleep-related breathing patterns.

Myocardial strain refers to the deformation (shortening, lengthening, or thickening) of the myocardium through the cardiac cycle. Myocardial strain can be measured by tissue Doppler imaging or, more recently, speckle-tracking echocardiography. Speckle-tracking echocardiography uses imaging software to assess the movement of specific markers in the myocardium that are detected in standard echocardiograms. It is proposed that a reduction in myocardial strain may indicate sub-clinical impairment of the heart and can be used to inform treatment before the development of symptoms and irreversible myocardial dysfunction.

Stroke prevention in patients with atrial fibrillation (AF) is an important goal of treatment. Treatment with anticoagulant medications is the most common approach to stroke prevention. Because most embolic strokes originate from the left atrial appendage, occlusion of the left atrial appendage may offer a nonpharmacologic alternative to anticoagulant medications to lower the risk of stroke. Multiple percutaneously deployed devices are being investigated for left atrial appendage closure (LAAC). Two types of left atrial appendage devices (the Watchman and Amplatzer Amulet devices) have approval from the U.S. Food and Drug Administration (FDA) for stroke prevention in patients with AF.

Ultrafiltration is used to remove excess fluid from patients with volume overload and heart failure. It removes fluid from the blood by using pressure differentials with dialysis equipment or similar filtration devices.

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. Two devices, MitraClip™ and PASCAL™, have 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. MitraClip is also approved for patients with heart failure and moderate-to-severe or severe symptomatic secondary MR despite the use of maximally tolerated guideline-directed medical therapy. The Edwards SAPIEN 3 transcatheter heart valve has been approved by the U.S. Food and Drug Administration for transcatheter mitral valve-in-valve replacement (TMViVR) in patients with a failing surgical bioprosthetic mitral valve who are at high or greater risk for repeat surgery.

Optical coherence tomography (OCT) is an imaging technique that uses near-infrared light to image the coronary arteries. Potential applications in cardiology include evaluating the characteristics of coronary artery plaques for the purpose of risk stratification and following coronary stenting to determine the success of the procedure. OCT has some advantages over intravascular ultrasound (IVUS) for imaging coronary arteries. It has a higher resolution and provides greater detail for accessible structures compared with IVUS. Case series have demonstrated that OCT can be performed with a high success rate and few complications. Head-to- head comparisons of OCT and IVUS have reported that OCT picks up additional abnormalities not detected by IVUS, implying that OCT is a more sensitive test than IVUS. As an adjunct to percutaneous coronary intervention (PCI), OCT may improve on the ability of IVUS to pick up clinically relevant abnormalities, and this may lead to changes in management. A single small randomized controlled trial did not report any advantage of OCT over IVUS for achieving optimal stent placement. Several noncomparative studies have addressed whether an OCT-guided treatment strategy involving deferred stenting is feasible. However, no comparative studies have been conducted to demonstrate improved clinical outcomes with such a strategy. Overall, the current evidence is limited and includes relatively small numbers of patients who have been evaluated by OCT. As a result, it is not possible to determine the degree of improvement with OCT, or the clinical significance of this improvement. Therefore, the use of OCT as an adjunct to PCI is considered investigational. For the indications of risk stratification of coronary plaques and follow-up of stenting, OCT may also be more accurate than IVUS for imaging of superficial structures. However, the clinical utility of IVUS has not been demonstrated for these indications, because test results do not lead to changes in management that improve outcomes. Therefore, clinical utility has not been demonstrated for OCT for the same reasons. As a result, OCT is considered investigational for risk stratification of coronary plaques and for follow-up poststent implantation.

A wearable cardioverter defibrillator (WCD) is a temporary, external device that is an alternative to an implantable cardioverter defibrillator (ICD). It is primarily intended for temporary conditions for which an implantable device is contraindicated, or for the period during which the need for a permanent implantable device is uncertain.

Various devices are available for outpatient cardiac rhythm monitoring. These devices differ in the types of monitoring leads used, the duration and continuity of monitoring, the ability to detect arrhythmias without patient intervention, and the mechanism of delivering the information from patient to clinician. These devices may be used to evaluate symptoms suggestive of arrhythmias (eg, syncope, palpitations), and may be used to detect atrial fibrillation (AF) in patients who have undergone cardiac ablation of AF or who have a history of cryptogenic stroke.

Atrial fibrillation frequently arises from an abnormal focus at or near the junction of the pulmonary veins and the left atrium, thus leading to the feasibility of more focused ablation techniques directed at these structures. Catheter-based ablation, using radiofrequency ablation or cryoablation, is a treatment option for various types of AF. Pulsed field ablation is a novel ablation technique for atrial fibrillation.

Progenitor cell therapy describes the use of multipotent cells of various cell lineages (autologous or allogeneic) for tissue repair and/or regeneration. Progenitor cell therapy is being investigated for the treatment of damaged myocardium resulting from acute or chronic cardiac ischemia and for refractory angina.

Hypertrophic cardiomyopathy is a complex cardiac disease associated with diverse clinical, morphologic, and pathophysiologic manifestations. However, one of the most characteristic abnormalities is a hypertrophied and nondilated left ventricle, which may impair diastolic filling. When the hypertrophy results in left ventricular outflow obstruction, dyspnea, angina, syncope, or the development of congestive heart failure may occur. Pharmacologic therapies include beta-blockers or calcium-channel blockers to decrease the heart rate with a consequent prolongation in diastole and increased passive ventricular filling. If medical therapy is insufficient to control symptoms, strategies to reduce the outflow obstruction may be considered. Surgical reaction focuses on removing a small amount of myocardium at the base of the septum (myotomy-myomectomy). Dual-chamber pacing has also been explored as a means of decreasing the pressure gradient in the outflow tract, although results of randomized trials have been disappointing. Transcoronary ablation of septal hypertrophy (TASH) has been explored as an alternative to open surgical septal resection. The technique involves infusion of ethanol through an angioplasty catheter threaded into the septal perforator branches of the left anterior descending artery to infarct and subsequently thin the bulging septum. A key component of the procedure is the identification of the target vessels. A balloon catheter is introduced into the septal branches. The balloon is inflated and contrast injected into the balloon lumen to delineate the area supplied by the septal branch and to ensure that the balloon inflation would prevent spillage of the subsequent injection of alcohol into the left anterior descending artery. Myocardial contrast echocardiography has also been used to target septal vessels. Echocardiographic contrast material may be injected into the balloon catheter and, using ultrasonography, the perfused area of the myocardium can be imaged from several different positions. TASH may also be referred to as ethanol septal ablation. <a id="

A variety of outpatient cardiac hemodynamic monitoring devices are intended to improve quality of life and reduce morbidity for patients with heart failure by decreasing episodes of acute decompensation. Monitors can identify physiologic changes that precede clinical symptoms and thus allow preventive intervention. These devices operate through various mechanisms, including implantable pressure sensors, thoracic bioimpedance measurement, inert gas rebreathing, and estimation of left ventricular end-diastolic pressure by arterial pressure during the Valsalva maneuver.

Patent foramen ovale (PFO) and atrial septal defects (ASDs) are relatively common congenital heart defects that can be associated with a range of symptoms. PFOs may be asymptomatic but have been associated with higher rates of cryptogenic stroke. PFOs have also been investigated for a variety of other conditions, such as a migraine. Depending on their size, ASDs may lead to left-to-right shunting and signs and symptoms of pulmonary overload. Repair of ASDs is indicated for patients with a significant degree of left-to-right shunting. Transcatheter closure devices have been developed to repair PFO and ASDs. These devices are alternatives to open surgical repair for ASDs or treatment with antiplatelet and/or anticoagulant medications in patients with cryptogenic stroke and PFO.

End-diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. Timed, sequential inflation during the end-diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic fluid. The available evidence, which consists of case series, is insufficient to determine if there is a role for enddiastolic pneumatic compression therapy in the treatment of peripheral vascular disease or lymphedema and its associated complications. Randomized controlled trials comparing outcomes with currently available treatments are required. Therefore, the treatment is considered investigational.

Ambulatory blood pressure (BP) monitors (24-hour sphygmomanometers) are portable devices that continually record BP while the patient is involved in daily activities. There are various types of ambulatory monitors; this evidence review addresses fully automated monitors, which inflate and record BP at preprogrammed intervals. Ambulatory blood pressure monitoring (ABPM) has the potential to improve the accuracy of diagnosing hypertension and thus improve the appropriateness of medication treatment.

Enhanced external counterpulsation (EECP) is a noninvasive treatment used to augment diastolic pressure, decrease left ventricular afterload, and increase venous return. EECP has been studied primarily as a treatment for patients with refractory angina and heart failure.

Catheter ablation is a technique for eliminating cardiac arrhythmias by selectively destroying a portion of myocardium or conduction system tissue that contains the arrhythmogenic focus. A variety of different energy sources can be utilized with catheter ablation, such as radiofrequency and/or cryotherapy. Supraventricular Arrhythmia For individuals who have supraventricular arrhythmias who receive catheter ablation, the evidence includes a randomized controlled trial (RCT) and numerous case series and uncontrolled trials. Relevant outcomes are overall survival, symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. Clinical series of paroxysmal supraventricular tachycardia have reported very high success rates at well over 90%. Serious complications, mainly atrioventricular block requiring pacemaker insertion, occur in approximately 1% of patients. High success rates are also reported for atrial flutter and focal atrial tachycardia. There are few comparative or trial data. The RCT assessing catheter ablation of the accessory pathway confirmed that incidence of arrhythmic events is greatly reduced with catheter ablation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Ventricular Arrhythmia For individuals with drug- and implantable cardioverter defibrillator (ICD)-refractory ventricular tachycardia (VT) due to structural heart disease who receive catheter ablation, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are overall survival, symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. Across 10 individual RCTs that compared catheter ablation with usual care (medical management) and 1 RCT that directly compared escalation of antiarrhythmic medications with catheter ablation in patients who had VTs and an automatic ICD, the evidence has shown that procedural success is 80% to 90%, and that catheter ablation is successful at reducing the number of VT episodes by about 30%. The evidence has further shown that catheter ablation is associated with approximately a 50% reduction in inappropriate ICD interventions compared with usual medical management alone. The rate of serious procedural adverse events is low. Late recurrences do occur, but most patients treated with ablation remain free of VT at 1- to 2-year follow-ups and 40% to 50% remain VT-free after 6 years of follow-up. The trial directly comparing catheter ablation with the escalation of medication found a 28% lower rate of a composite of death, VT storm, and appropriate ICD shock among patients undergoing catheter ablation vs those receiving an escalation in antiarrhythmic drug therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals who have idiopathic VT refractory to drug therapy and ICD placement who receive catheter ablation, the evidence includes a few case series. Relevant outcomes are overall survival, symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. There are no comparative or trial data and, given the rarity of the disease, such RCTs are unlikely. Case series have reported high success rates and low adverse event rates with catheter ablation. However, the body of literature is small. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have VT storm who have failed pharmacologic treatment who receive catheter ablation, the evidence includes a few case series. Relevant outcomes are overall survival, symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. Serious complications have been reported at reasonably low rates, and mortality from the procedure was reported to be 0.6% in a meta-analysis of case series. There are no comparative or trial data. Because of the emergent nature of this condition, RCTs are not expected to be performed. In these situations, morbidity and mortality are expected to be extremely high in patients who have failed pharmacologic therapy; therefore, catheter ablation is expected to reduce morbidity and mortality. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. Clinical input obtained in 2012 has supported the use of catheter ablation to treat VT and other ventricular arrythmias.

Cardiac resynchronization therapy (CRT), which consists of synchronized pacing of the left and right ventricles, is intended to treat individuals with heart failure and dyssynchronous ventricular contractions. Treatment involves placement of a device that paces both ventricles and coordinates ventricular pacing to maximize cardiac pumping function and left ventricular ejection fraction (LVEF).

Complete Appendix to Guidelines available at http://journals.aace.com. Endocr Pract. Apr 02 2017; 23(4): 479-497. PMID 28156151″>33,

The electrocardiogram (ECG or EKG) is a noninvasive test that is used to reflect underlying heart conditions by measuring the electrical activity of the heart. By positioning leads (electrical sensing devices) on the body in standardized locations, information about many heart conditions can be learned by looking for characteristic patterns on the EKG. Routine EKG: A routine EKG is defined as one that is performed without there being documentation in the medical record of medical necessity. Medical Necessity: Those services that a doctor, exercising his prudent clinical judgment, provides to his patients. These services must be based on the standards accepted in the medical practice and must be the product of scientific evidence published by peers, recommendations from the different recognized specialties. Must be appropriate and effective services that are not provided primarily for the convenience of the patient or provider and not more expensive than an alternate service similar or equivalent. Sedation: Drug-induced state of consciousness where the patient responds normally to intentional verbal commands, and where cognitive function and coordination may be impaired. Cardiovascular and ventilatory functions they are not affected. Analgesia: The use of medicines usually derived from opium, to reduce feeling of pain and/or nociceptive stimu (pain receptors in the skin). Monitoring: Monitoring is the continuous evaluation of the patient, before, during and after theadministration of sedatives and/or analgesics used in preparation for the endoscopic procedure <a id="

The electrocardiogram (ECG or EKG) is a noninvasive test that is used to reflect underlying heart conditions by measuring the electrical activity of the heart. By positioning leads (electrical sensing devices) on the body in standardized locations, information about many heart conditions can be learned by looking for characteristic patterns on the EKG. EKG services are covered diagnostic tests when there are documented signs and symptoms or other clinical indications for providing the service. Coverage includes the review and interpretation of EKGs only by a physician. There is no coverage for EKG services when rendered as a screening test or as part of a routine examination unless performed as part of the one-time, "Welcome to Medicare" preventive physical examination under section 611 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. <a id="

A ventricular assist device (VAD) is mechanical support attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. Both the VAD and TAH may be used as a bridge to heart transplantation or as destination therapy. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.

Primary percutaneous transluminal coronary angioplasty (PTCA), also referred to as direct, immediate, or infarct angioplasty, is one method to intervene with acute myocardial infarction symptoms. It is intended to be performed within 6 to 12 hours of the onset of acute myocardial infarction symptoms. It was developed as an alternative to thrombolytic therapy (thrombolytic drugs administered to dissolve thrombi). <a id="

High-intensity laser therapy (HILT) is a Class IV therapeutic non-surgical laser device with a power output >500 mW that is capable of transmitting energy beyond the skin to deep musculoskeletal tissues.  HILT is proposed for use in the office setting for various indications including musculoskeletal disorders and Bell’s palsy. 

Digital health technologies is a broad term that includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device, and include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). The scope of this review includes only those digital technologies that are intended to be used for diagnostic application (detecting the presence or absence of a condition, the risk of developing a condition in the future, or treatment response [beneficial or adverse]) and meet the following 3 criterion- 1) Must meet the definition of "Software as a medical device" which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information. 2) Must have received marketing clearance or approval by the U.S. Food and Drug Administration either through the de novo premarket process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider.

While peanut allergy is the most common cause of food allergy among children in the United States, deaths from accidental peanut exposure are rare. Approximately 80% of individuals who develop peanut allergy early in childhood do not outgrow their allergy, and over half of them suffer from additional food allergies. Diagnosis of peanut allergy is made with an unequivocal history of an immediate allergic reaction following peanut ingestion, use of a skin prick test, and peanut-specific IgE levels. Strict allergen avoidance is the standard of care. Peanut (Arachis hypogaea) allergen powder-dnfp is a defatted, slightly roasted peanut flour with a characterized peanut allergen profile, and gradually increasing doses are given orally to desensitize patients.

Trigger points are discrete, focal, hyperirritable spots within a taut band of skeletal muscle fibers that produce local and/or referred pain when stimulated. Tender points also produce local pain when stimulated but lack the taut band of tissue and hyperirritability when palpated. Injection of an anesthetic agent or botulinum toxin into trigger points and tender points is being evaluated for the management of a variety of pain syndromes.

OR (95% CI): 3 mos: 0.69 (0.22 to 2.17) 6 mos: 0.57 (0.18 to 1.81) 12 mos: 1.23 (0.37 to 4.12) Mean Treatment Difference (95% CI): 3 mos: -3.7 (-11.5 to 4.0) 6 mos: -6.4 (-11.9 to 0.3) 12 mos: 3.7 (-4.3 to 11.6) Mean Treatment Differences (95% CI): 3 mos: -6.5 (-13.4 to 0.4) 6 mos: -3.6 (-10.7 to 3.5) 12 mos: -1.2 (-8.2 to 5.9) Mean Treatment Differences (95% CI): 3 mos: -0.1 (-1.2 to 1.1) 6 mos: 0.3 (-0.9 to 1.5) 12 mos: -0.1 (-1.2 to 1.1) NR Mahler et al (2018)17,; Ende et al (2020)19, OMERACT-OARSI WOMAC Pain WOMAC Function PGA LDRT (n=27) 3 mos: 44% 6 mos: 41% 12 mos: 52% Any reaction: 10 (37%) Skin reactions: 5 (19%) Nail reactions: 4 (15%) Fatigue: 6 (22%) Other reactions: 3 (11%) Serious AEs: 0% Sham (n=27) 3 mos: 43% 6 mos: 35% 12 mos: 44% Any reaction: 10 (36%) Skin reactions: 5 (18%) Nail reactions: 3 (11%) Fatigue: 4 (14%) Other reactions: 4 (14%) Serious AEs: 3 (11%) <td style="padding-left: 8px; padding-top: 4px; padding-bottom: 4px; line-height: 1.2; font-weight: normal !important; background-color: rgb(255, 255, 255) !important; font-size: 9pt !important; color: rgb(0, 0, 0) !important; border: 1px solid rgb(128, 0, 0); font-family: Arial; text-align: left !important; width: 265.094px;" width="96"

Vitiligo is an idiopathic skin disorder that causes depigmentation of sections of skin, most commonly on the extremities. Topical corticosteroids, alone or in combination with topical vitamin D3 analogues, are common first-line treatments for vitiligo. Alternative first-line therapies include topical calcineurin inhibitors, systemic steroids, and topical antioxidants. Treatment options for vitiligo recalcitrant to first-line therapy include, among others, ultraviolet B, light box therapy, and psoralen plus ultraviolet A (PUVA). Targeted phototherapy is also being evaluated.

Epidural steroid injections (ESIs) are a treatment for neck or back pain that has not responded to conservative measures. Local steroid injections may improve pain by reducing inflammation, thus relieving pressure on nerve roots or other structures that may be the origin of pain.

Fecal microbiota transplantation (FMT) involves the administration of intestinal microorganisms via the transfer of stool from a healthy person into a diseased individual, with the intent of restoring normal intestinal flora. Fecal transplant is proposed for treatment-refractory Clostridioides (formerly Clostridium) difficile infection (CDI) and other conditions, including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), pouchitis, constipation, multi-drug resistant organism (MDRO) infection, or metabolic syndrome.

Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for individuals to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure that uses the oral cavity as a natural orifice entry point to perform myotomy of the lower esophageal sphincter (LES). This procedure is intended to reduce the total number of incisions needed and thus the overall invasiveness of surgery. Gastric peroral endoscopic myotomy (G-POEM) is a similar procedure with the exception that it myotomizes the pylorus rather than LES.

Confocal laser endomicroscopy (CLE), also known as confocal fluorescent endomicroscopy and optical endomicroscopy, allows in vivo microscopic imaging of cells during endoscopy. Confocal laser endomicroscopy is proposed for a variety of purposes, especially as a real-time alternative to biopsy/polypectomy and histopathologic analysis during colonoscopy and for targeting areas to undergo biopsy in individuals with inflammatory bowel disease or Barrett esophagus.

Neural therapy involves the injection of a local anesthetic such as procaine or lidocaine into various tissues such as scars, trigger points, acupuncture points, tendon and ligament insertions, peripheral nerves, autonomic ganglia, the epidural space, and other tissues to treat chronic pain. Neural therapy has been proposed for other chronic illness syndromes such as allergies, infertility, tinnitus, multiple sclerosis, depression, and chronic bowel problems. When the anesthetic agent is injected into traditional acupuncture points, this treatment may be called neural acupuncture.

Biofeedback is a technique to teach individuals self-regulation of physiological processes not generally considered to be under voluntary control; a variety of approaches and devices are available. Among possible indications, biofeedback is proposed as a treatment for fecal incontinence and constipation.

Dizziness, vertigo, and balance impairments can arise from a loss of vestibular function. A number of established laboratory-based tests are used to evaluate whether the symptoms are due to dysfunction of the semicircular canals. These tests are based on the vestibulo-ocular reflex, which is an involuntary movement of the eyes (nystagmus) in response to vestibular stimulation. Established laboratory tests include electronystagmography and videonystagmography test batteries, caloric stimulation, and rotational chair testing. Vestibular evoked myogenic potentials (VEMPs), triggered by sound and vibration, are also being evaluated for the diagnosis of otolith dysfunction.

Onychomycosis is a common fungal infection of the nail. Currently, available treatments for onychomycosis, including systemic and topical antifungal medications, have relatively low efficacy and require a long course of treatment. Laser systems are proposed as another treatment option.

Photodynamic therapy (PDT) refers to light activation of a photosensitizer to generate highly reactive intermediaries, which ultimately cause tissue injury and necrosis. Photosensitizing agents are being proposed for use with dermatologic conditions such as actinic keratoses (AKs) and nonmelanoma skin cancers.

Biofeedback is a technique to teach individuals self-regulation of physiologic processes not generally considered to be under voluntary control; a variety of approaches and devices are available. Biofeedback, in conjunction with pelvic floor muscle training, is proposed as a treatment of urinary incontinence.

Description – Intro Neurofeedback describes techniques for providing feedback about neuronal activity, as measured by electroencephalogram biofeedback, functional magnetic resonance imaging, or near-infrared spectroscopy, to teach patients to self-regulate brain activity. Neurofeedback may use several techniques in an attempt to normalize unusual patterns of brain function in patients with various psychiatric and central nervous system disorders.

Navigated transcranial magnetic stimulation (nTMS) is a noninvasive imaging method for evaluating eloquent brain areas (eg, those controlling motor or language function). Navigated TMS is being evaluated as an alternative to other noninvasive cortical mapping techniques for presurgical identification of eloquent areas.

Polysomnography records multiple physiologic parameters relevant to sleep. Video recording may also be performed during polysomnography to assess parasomnias such as rapid eye movement sleep behavior disorder.

Intra-articular injection of hyaluronan into osteoarthritic joints is proposed to reduce pain and improve function. It is thought to replace endogenous hyaluronan and restore the viscoelastic properties of the synovial fluid. Most studies to date have assessed hyaluronan injections for knee osteoarthritis, the U.S. Food and Drug Administration approved indication. Other joints (eg, hip, shoulder) are being investigated for intra-articular hyaluronan treatment of osteoarthritis.

Gazyva (obinutuzumab) is an antineoplastic agent, anti-CD20 monoclonal antibody. For individuals who have NHL who receive obinutuzumab alone or combined with chemotherapy, the evidence includes RCTs. Relevant outcomes are overall survival, change in disease status, quality of life, and treatment-related morbidity. Obinutuzumab was approved by the Food and Drug Administration for the treatment of FL in patients who have relapsed or are refractory to a rituximab-containing regimen; the drug was also approved for use in combination with chlorambucil for previously untreated CLL in combination with bendamustine. These indications are based on positive results in phase 3 trials that compared combination therapy with monotherapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Pembrolizumab (Keytruda®) is a programmed death receptor-1 (PD-1) blocking antibody that enhances T-cell immune responses against tumor cells. It is FDA-approved for multiple malignancies including melanoma, NSCLC, mesothelioma, HNSCC, Hodgkin lymphoma, PMBCL, urothelial carcinoma, MSI-H/dMMR solid tumors, gastric/GEJ adenocarcinoma, esophageal carcinoma, cervical cancer, hepatocellular carcinoma, biliary tract cancer, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, TMB-H tumors, cutaneous squamous cell carcinoma, triple-negative breast cancer, and others. >

Opdivo® (nivolumab) is a PD-1 inhibitor indicated in multiple solid tumors and hematologic malignancies. It improves overall survival, progression-free survival, and response rates, in monotherapy or in combination. The subcutaneous formulation (Opdivo Qvantig™) was approved in 2025. <a id="

Portable devices have been developed to provide point-of-care (POC) nerve conductions studies (NCSs). These devices have computational algorithms thatcandrive stimulus delivery, measure and analyze the response, and report study results. Automated nerve conduction couldbe usedin various settings, including primary care, without the need for specialized training or equipment. For individuals who have entrapment carpal tunnel syndrome who received automated POC NCSs, the evidence includes studies on the diagnostic accuracy and clinical outcomes from industry-sponsored trials, nonrandomized trials, and registry data. Relevant outcomesare testaccuracy and validity, symptoms, and functional outcomes. Four RCTs have reported on the diagnostic accuracy of automated POC nerve conduction testing to diagnose carpal tunnel syndrome. Sensitivity testing has suggested there could be diagnostic value in detecting carpal tunnel syndrome; specificity testing was inconsistent across trials. No reference ranges werevalidated,and normative valueswere not definedin these studies. No validation testing by trained medical assistantsvstrained specialistwas reportedin the studies. The evidence on clinical outcomes is limited to a single nonrandomized clinical trial and NeuroMetrix registry data. Neither reported health outcomes assessing patient symptoms or changes in functional status. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals with lumbosacral radiculopathy who received automated POC NCSs, the evidence includes industry-sponsored trials and a nonrandomized study of diagnostic accuracy. Relevant outcomesare testaccuracy and validity, symptoms, and functional outcomes. The evidence onthediagnostic accuracy of POC NCS in this population has shown variable test results across reported trials. No normative valueswere defined. Weaknesses of the studies included lack of applicable or valid reference ranges for testing, and variable test results validating or confirming pathology. The results of the2studies on diagnostic performance were inconclusive, with high false-positive results in a single trial. No trials on health outcomes assessing patient symptoms or changes in functional statuswere identified. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals with diabetic peripheral neuropathy who received automated POC NCSs, the evidence includes industry-sponsored observational trials and nonrandomized studies on the diagnostic accuracy.Relevant outcomesare testaccuracy and validity, symptoms, andfunctional outcomes. Of 3studies reporting evidence on diagnostic accuracy, two used NC-stat DPNCheck. Sensitivity testing has suggested there could be diagnostic value in detecting diabetic peripheral neuropathy in symptomatic patients; the evidence to detect patients whoare suspectedof disease but who have mild symptoms was inconsistent. No reference ranges werevalidated,and normative valueswere not definedin 2 of the3studies. No validation testing by trained medical assistantsvstrained specialistwas reportedin the studies. No trials on health outcomes assessing patient symptoms or changes in functional statuswere identified. The evidence is insufficient to determine the effects of the technology on health outcomes. <a id="

Morton neuroma is a common and painful compression neuropathy of the dorsal foot that is also referred to as intermetatarsal neuroma, interdigital neuroma, interdigital neuritis, and Morton metatarsalgia. Morton neuroma is usually treated with conservative measures, surgery, or minimally invasive procedures. Alcohol injection is a minimally invasive alternative to open surgery to treat Morton neuroma. Alcohol causes chemical neurolysis through dehydration, necrosis, and precipitation of the treated area, ultimately destroying the lesion after multiple injections. For individuals who have Morton neuroma who receive intralesional alcohol injection(s), the evidence includes retrospective case series. Relevant outcomes are symptoms, resource utilization, and treatment-related morbidity. The body of evidence is limited, consisting of case series reporting on the treatment response of patients with refractory Morton neuroma. The available series have generally reported that some patients experience pain relief and express satisfaction with the procedure. Some evidence has suggested that surgery after failed cases of alcohol injections is more complex and challenging than in untreated patients due to the presence of fibrosis. There is a lack of controlled trials comparing alcohol injections with alternative therapies, and there are no controlled studies comparing outcomes for alcohol injections with those for surgery in surgical candidates. The evidence is insufficient to determine the effects of the technology on health outcomes.

An ingestible pH and pressure-sensing capsule (SmartPill GI Monitoring System) measures pH, pressure, and temperature changes to signify the passage of the capsule through portions of the gastrointestinal tract. It is proposed as a means of evaluating gastric emptying for diagnosis of gastroparesis, and colonic transit times for the diagnosis of slow-transit constipation. For individuals who have suspected disorders of gastric emptying or suspected slow-transit constipation who receive diagnostic testing with an ingestible pH and pressure capsule, the evidence includes studies of test characteristics and case series of patients who have undergone the test. Relevant outcomes are test validity, other performance measures, symptoms, functional outcomes, and health status measures. The available studies have provided some comparative data on the SmartPill ingestible pH plus pressure-sensing capsule and other techniques for measuring gastric emptying. This evidence primarily consists of assessments of concordance with available tests. Because the available tests (eg, gastric emptying scintigraphy) are imperfect criterion standards, it is not possible to determine the true sensitivity and specificity of SmartPill. The results of the concordance studies have revealed a moderate correlation with alternative tests, but have provided only limited additional data on the true accuracy of the test in clinical care. Evaluation of cases with discordant results would be of particular value and, ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes. The evidence to date on the clinical utility of testing is lacking, consisting of a small number of retrospective studies. It is not possible to determine whether there is net improvement in health outcomes using SmartPill vs standard diagnostic tests. The evidence is insufficient to determine the effects of the technology on health outcomes.

Low-frequency ultrasound in the kilohertz range may improve wound healing. Several noncontact low-frequency ultrasound (NLFU) devices have received regulatory approval for wound treatment.

The use of platelet-rich plasma has been proposed as a treatment for various musculoskeletal conditions and as an adjunctive procedure in orthopedic surgeries. The potential benefit of platelet-rich plasma has received considerable interest due to the appeal of a simple, safe, low-cost, and minimally invasive method of applying growth factors.

Chronic intermittent intravenous insulin therapy (CIIIT) is a technique for delivering variable-dose insulin to diabetic patients with the goal of improved long-term glycemic control. Through an unknown mechanism, CIIIT is postulated to induce insulin-dependent hepatic enzymes to suppress glucose production.

Hypnosis is an induced state in which there is an increased amenability and responsiveness to suggestions and commands. Hypnosis is not intended to cure disease but rather to relieve symptoms of illness <a id="

Secondary lymphedema may develop following treatment for breast cancer. Bioimpedance, which uses resistance to electrical current to compare the composition of fluid compartments, could be used as a tool to diagnose lymphedema.

Chromoendoscopy refers to the use of dyes or stains during endoscopy to enhance tissue differentiation or characterization. When used with colonoscopy, the intent is to increase the sensitivity of the procedure by facilitating the identification of mucosal abnormalities. There are 2 types of chromoendoscopy: 1 involves actual spraying of dyes or stains through the working channel of an endoscope; the other, known as virtual chromoendoscopy, uses a computer algorithm to simulate different colors of light that result from dye or stain spraying.

Light therapy for psoriasis includes phototherapy with ultraviolet B (UVB) light boxes, targeted phototherapy, and photochemotherapy with psoralen plus ultraviolet A (PUVA). Targeted phototherapy describes the use of ultraviolet light focused on specific body areas or lesions. PUVA uses a psoralen derivative in conjunction with long-wavelength ultraviolet A light (sunlight or artificial) for photochemotherapy of skin conditions. For individuals who have mild localized psoriasis who receive targeted phototherapy, there is little evidence. The relevant outcomes are symptoms, change in disease status, quality of life (QOL), and treatment-related morbidity. The evidence is lacking on the use of targeted phototherapy as the first-line treatment of mild psoriasis. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have mild psoriasis that is resistant to topical medications who receive targeted phototherapy, the evidence includes small within-subject studies. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. The available pre-post studies have shown that targeted phototherapy can improve mild localized psoriasis (<10% body surface area) that has not responded to topical treatment. Targeted phototherapy is presumed to be safer or at least no riskier than whole body phototherapy, due to risks of exposing the entire skin to the carcinogenic effects of UVB light. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals who have moderate-to-severe localized psoriasis who receive targeted phototherapy, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. Systematic reviews of small RCTs and non-RCTs in patients with moderate-to-severe psoriasis have found that targeted phototherapy has efficacy similar to whole-body phototherapy and supports the use of targeted phototherapy for the treatment of moderate-to-severe psoriasis comprising less than 20% of body surface area for which narrowband UVB or phototherapy with PUVA are indicated. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals who have generalized psoriasis who receive PUVA, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. RCTs and systematic reviews of RCTs have found that PUVA is more effective than narrowband UVB, topical steroids, or ultraviolet A without psoralens in patients with generalized psoriasis. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Biofeedback is frequently used in conjunction with other therapies (eg, relaxation, behavioral management, medication) to reduce the severity and/or frequency of headaches.

Home oxygen therapy is used to treat and prevent symptoms and manifestations of hypoxemia. Home oxygen therapy can be indicated in severe pulmonary diseases like chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease, cystic fibrosis, bronchiectasis or lung cancer. Oxygen therapy can also be indicated in conditions with hypoxia symptoms like pulmonary hypertension, erythrocytosis, recurring heart failure due to chronic cor pulmonale. Short term therapy can be indicated in pneumonia, asthma, bronchitis or bronchiolitis. Hypoxemia needs to be demonstrated with an arterial blood gas (ABG) test. This test should be done at room air unless medically contraindicated. Oxygen therapy frequency, flow and duration needs to be prescribed by a physician when starting therapy. Therapy long term necessity needs to be evaluated with pulse oximetry every three months, each time an increase in oxygen is required or when equipment type change is needed. <a id="

Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes that are otherwise impossible or extremely difficult to control. This review focuses on the use of biofeedback for treating miscellaneous indications-specifically, indications other than urinary and fecal incontinence, headache, and chronic pain.

Sublingual immunotherapy (SLIT) is a potential alternative to subcutaneous immunotherapy (SCIT) for providing allergen-specific therapy. SLIT is proposed as a more convenient alternative delivery route for treating a variety of allergic disorders.

In Barrett esophagus (BE), the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia. Intestinal metaplasia is a precursor to adenocarcinoma and may be treated with mucosal ablation techniques such as radiofrequency ablation (RFA) or cryoablation.

Transcranial magnetic stimulation (TMS) is a noninvasive method of delivering electrical stimulation to the brain. The technique involves the placement of a small coil over the scalp and the passing of a rapidly alternating current through the coil wire. The electrical current produces a magnetic field that passes unimpeded through the scalp and bone and stimulates neuronal function. Repetitive TMS is being evaluated for the treatment of treatment-resistant depression (TRD) and other psychiatric and neurologic disorders. A variety of TMS modalities have been developed, which differ on parameters including stimulation intensity, frequency, pattern, and site of the brain stimulation. In conventional TMS, high frequency stimulation is delivered over the left dorsolateral prefrontal cortex (DLPFC) or low frequency stimulation over the right DLPFC. In bilateral TMS, both procedures are performed in the same session. Deep TMS employs an H-coil helmet designed to encompass a broader surface area and stimulate deeper brain structures than conventional TMS. Theta burst stimulation is administered at lower intensities and shorter intervals than conventional TMS.

Dynamic posturography tests an individual's balance control in situations intended to isolate factors that affect balance in everyday experiences. Posturography provides quantitative information on the degree of imbalance present but is not intended to diagnosis specific types of balance disorders.

Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Electromyography biofeedback has been evaluated as a method to reduce chronic or recurrent pain of musculoskeletal or psychosomatic origin.

Actigraphy refers to the assessment of body movement activity patterns using devices, typically placed on the wrist or ankle, during sleep, which are interpreted by computer algorithms as periods of sleep and wake. Sleep-wake cycles may be altered in sleep disorders, including insomnia and circadian rhythm sleep disorders. Also, actigraphy could be used to assess sleep/wake disturbances associated with other disorders.

The standard treatment of problem fractures or osseous defects has been an autologous cancellous bone graft harvested from the iliac crest. Limitations of this approach include morbidity at the graft site and the lack of adequate bone stock in some patients. Autologous bone graft is considered the gold standard because it includes components of all 3 processes considered to be essential for bone healing: osteoconductivity (i.e., a support structure), osteoinductivity (i.e., ability of graft to induce nondifferentiated stem cells to differentiate into osteoblast) and osteogenic cells. Therefore, bone graft substitutes, used either alone or in combination are designed to reproduce these components. The extracellular bone matrix includes a wide range of bone growth factors, proteins, and other bioactive materials necessary for osteoinduction. These factors can be removed from allograft bone by using a demineralizing agent, resulting in demineralized bone matrix (DBM). Several different preparations of DBM are commercially available, including putty, gel, and paste, which can be used as an adjunct to a variety of open surgical procedures. In contrast, the Ignite™ ICS product consists of a DBM that is designed to be injectable, thus enabling percutaneous treatment. Autologous bone marrow aspirate is designed to provide marrow stromal cells and osteogenic cells, and has been investigated as a stand-alone treatment of fracture, or in conjunction with demineralized bone marrow. The Ignite™ ICS product is specifically designed to be used in conjunction with bone marrow aspirate, and has the following labeled indication: “After the powder is mixed with autologous bone marrow aspirate, the resultant composite material can then be injected into the defect site. Ignite™ ICS is indicated only for bone voids or gaps that are not intrinsic to the stability of the bony structure. Ignite™ ICS is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.” Various different preparations of DBM are commercially available, regulated by the U.S. Food and Drug Administration (FDA) as either human tissue or cleared through the 510(k) marketing clearance process. An example of a DBM preparation that is regulated as a human tissue is Osteotech’s Grafton® and 3 preparations that have received 510(k) marketing clearance are the Wright Medical Allomatrix®, Exactech Resorbable Bone Paste, and DBX® from the Musculoskeletal Transplant Foundation. Bone morphogenetic protein (BMP) is another bone graft alternative and consists of a bioengineered equivalent of 1 of the components of bone matrix. Various BMP preparations have been FDA approved through the more rigorous PMA process, which does require evidence of clinical efficacy. BMP is discussed in MPRM Policy No.7.01.100. <a id="

Electromyography and nerve conduction studies, also collectively known as an electrodiagnostic assessment, evaluate the electrical functioning of muscles and peripheral nerves. These tests are diagnostic aids for the evaluation of myopathy and peripheral neuropathy by identifying, localizing, and characterizing electrical abnormalities in the skeletal muscles and peripheral nerves.

Conventional laser therapy has been used in Europe for more than 25 years. Up to this moment, this therapy has consisted in the use of low or medium intensity devices. Their results have raised interest, although their effectiveness has not been proven by studies of long-term controlled results. Its use has been limited to superficial tissues since the doses of energy necessary to treat deep tissues induce thermal damage to these. <a id="

Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in individuasl with symptoms of, or the potential for, neurologic damage or disease. Types of sensory testing include current perception threshold testing, pressure-specified sensory testing, vibration perception testing (VPT), and thermal sensory testing. Information on sensory deficits identified using QST has been used in research settings to better understand neuropathic pain. It could be used to diagnose conditions linked to nerve damage and disease, and to improve patient outcomes by impacting management strategies.

Intracranial arterial disease includes thromboembolic events, vascular stenoses, and aneurysms. Endovascular techniques have been investigated for the treatment of intracranial arterial disease. Endovascular therapy is used as an alternative or adjunct to intravenous tissue plasminogen activator and supportive care for acute stenosis and as an adjunct to risk-factor modification for chronic stenosis. For cerebral aneurysms, stent-assisted coiling and the use of flow-diverting stents have been evaluated as an alternative to endovascular coiling in patients whose anatomy is not amenable to simple coiling.

Electrostimulation (electrical stimulation) refers to the application of electrical current through electrodes placed directly on the skin. Electromagnetic therapy involves the application of electromagnetic fields, rather than direct electrical current. Both are proposed as treatments for wounds, generally chronic wounds.

Acne is a condition of the pilosebaceous follicular glands that affects mainly adolescents and young adults and that can be classified as inflammatory and non-inflammatory. Acne is characterized by the presence of comedones, nodules and rashes of papules, pustules and nodulocystic lesions. The lesions are found in areas of higher concentration of sebaceous glands such as face, neck and upper trunk. The four main causal factors are; 1. Sebaceous glandular hyperplasia with excess production of sebum, mediated by androgens. 2. Abnormal follicular keratinization that promotes clogging of the follicles and the formation of comedones. 3. Proliferation of propionibacterium acne (P. acne). Inflammation occurs as a result of P.acnes products. 4. Genetic factors, diet, and stress can contribute to the development and severity of acne. The treatment consists of good skin care, benzoyl peroxide, antibiotics and retinoids. Active acne must be differentiated from acne scarring, since it represents the residual damage to the tissue after the inflammation disappears. The pulse laser has been used in the treatment of acne scarring. Recently it has been tried in the treatment of the active phase of acne. Laser therapy at different levels of radiation has been used to destroy active acne lesions and enlarged sebaceous glands. It is postulated that the laser improves the injuries of active acne, reducing the presence of P. acnes that contains porphyrins that are destroyed when exposed to specific wave lengths. Laser also has anti- inflammatory effects and can reduce or limit the healing potential that can occur in severe cases. The FDA has approved several devices for the treatment of acne: · Candela Smoothbeam ™ · CoolTouch® use light in the 1320nm band · Radiancy ClearTouch ™ · MED flash II · Ellipse I2PL in the band of 590-1200nm (intense pulsed light) and those that emit violet or blue light · Band of 414nm and pink light · 633nm band · Aura ™ · Clearligth · Dermillume respectively The indications of each type of light vary according to the type of acne.D <a id="

A noninvasive procedure that records the summation of muscle electrical activity, paraspinal surface electromyography (SEMG) has been investigated as a technique to evaluate the physiologic functioning of the back. Additionally, this procedure has been studied as a technique to evaluate abnormal patterns of electrical activity in the paraspinal muscles in individuals with back pain symptoms, such as spasm, tenderness, limited range of motion, or postural disorders.

Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen at pressures between 1.5 and 3.0 atmospheres. It is generally applied systemically with the patient inside a hyperbaric chamber. HBOT can also be applied topically; ie, the body part to be treated is isolated (eg, in an inflatable bag and exposed to pure oxygen). HBOT has been investigated for various conditions that have potential to respond to increased oxygen delivery to tissue.

Rosacea is a chronic, inflammatory skin condition without a known cure; the goal of treatment is symptom management. Nonpharmacologic treatments, including laser and light therapy as well as dermabrasion, which are the focus of this evidence review, are proposed for patients who do not want to use or are unresponsive to pharmacologic therapy.

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.