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Clinical Coverage Guidelines (CCGs) and Claims Edit Guidelines (CEGs)

View Experimental/Investigational CCG's.

Medicaid Clinical Coverage Guidelines (CCGs)

A

Acne vulgaris (acne) is the formation of comedones, papules, pustules, nodules, and/or cysts as a result of obstruction and inflammation of pilosebaceous units (hair follicles and their accompanying sebaceous gland).

Medically appropriate air ambulance transportation is a covered service regardless of the State or region in which it is rendered.

Aquatic therapy is an active therapeutic intervention that takes place in water.

B

OnabotulinumtoxinA (Botox) injections have been found to be effective in individuals with a variety of medical conditions.

The most common reason for breast reconstruction is to repair defects caused by breast cancer. Breast cancer is the second most frequently occurring cancer in the United States.

Johns Hopkins Health Library defines burns as a type of painful wound caused by thermal, electrical, chemical, or electromagnetic energy.

C

The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitor proven to significantly reduce heart failure hospital admissions and improve quality of life in New York Heart Association (NYHA) class III patients.

Chelation therapy is an established treatment for heavy metal poisoning.

Chiropractic manipulative treatment (CMT) is a form of manual treatment to influence joint and neurophysiological function.

Medical necessity guidelines for routine costs of clinical trials in accordance with Centers for Medicare & Medicaid (CMS) and the Patient Protection and Affordable Care Act (PPACA) requirements.

The FDA assigns a special identifier number that corresponds to each device granted an investigational device exemption (IDE).

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol.

Diabetes mellitus is characterized by hyperglycemia due to impaired pancreatic insulin secretion or inefficient use of insulin by the body.

This policy outlines medical necessity criteria for the replacement of cochlear implants and/or cochlear implant components.

Diagnostic Testing Guidelines for 2019 Novel Coronavirus HS-326

Cranial orthotic devices are used in infants for the treatment of positional plagiocephaly, deformation of the head that results from external pressure applied to the soft infant skull.

The American College of Physicians and the American Pain Society (ACP/APS) published a joint clinical guideline for the diagnosis and treatment of low back pain; spinal manipulation is recommended for patients who do not improve with self-care options.

D

Some medical conditions may result in a condition called lipoatrophy, characterized by facial wasting of fat under the skin of the face and other parts of the body.

Genetic testing can be performed for several reasons; predominantly among these reasons are 1) using genetic testing as a diagnostic tool, and 2) using testing as a mechanism for predicting the presence of a specific disease in those with a familial history.

Diaphragmatic/phrenic nerve stimulator devices are indicated for certain ventilator-dependent individuals who lack voluntary control of their diaphragm muscles to enable independent breathing without the assistance of a mechanical ventilator for at least four continuous hours a day.

The U.S. Food and Drug Administration (FDA) approved Duopa (a formula of carbidopa and levodopa) to treat a small subset of patients with advanced Parkinson’s disease.

Testing for drugs of abuse is performed to detect the use of prescription medications and illegal substances for the purpose of medical treatment.

E

Evidence from the reviewed studies indicates that exhaled NO demonstrates moderate to good accuracy in diagnosing asthma and may be useful in predicting and monitoring inflammatory responses indicative of asthma exacerbation before and during anti-inflammatory treatment.

The FDA describes Duchenne muscular dystrophy (DMD) as a rare genetic disorder characterized by progressive muscle deterioration and weakness.

This policy outlines general guidelines to use in determining coverage of experimental or investigational, or potentially experimental or investigational medical and behavioral health technologies.

Sudden cardiac death (SCD) is typically defined as unanticipated death due to cardiac causes that occur within 1 hour of the onset of acute symptoms.

F

Fecal incontinence defined as the uncontrolled passage of feces or gas over at least 1 month’s duration, in an individual of at least four years of age, who had previously achieved control.

Uterine fibroids (or leiomyomas) are benign soft tissue neoplasms that arise from smooth muscle. These lesions can develop wherever smooth muscle is present, but malignant transformation probably does not occur.

G

Services for gender affirmation most often include hormone treatment, counseling, psychotherapy, complete hysterectomy, bilateral mastectomy, chest reconstruction or augmentation as appropriate, genital reconstruction, facial hair removal, and certain facial plastic reconstruction

Gender reassignment therapy, either as male-to-female transsexuals (transwomen) or as female-to-male transsexuals (transmen), consists of medical and surgical treatment that changes primary or secondary sex characteristics.

Growth Hormone Deficiency (GHD) is a rare disorder characterized by the inadequate secretion of growth hormone (GH) from the anterior pituitary gland, a small gland located at the base of the brain that is responsible for the production of several hormones.

H

Hearing aids are electronic amplifying devices designed to bring sound more effectively into the ear.

Hyperbilirubinemia is the most common condition requiring medical attention in newborns.

Non-invasive ventilation (NIV) refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube).

Per CMS, for purposes of coverage under Medicare, hyperbaric oxygen therapy (HBOT) is a modality in which the entire body is exposed to oxygen under increased atmospheric pressure.

I

The implanted device measures and monitors daily pulmonary artery (PA) pressure. The data is used by physicians for heart failure management with the goal of reducing heart failure hospitalizations.

J

Hemophilia A, factor VIII deficiency, is a recessive X-chromosome linked inherited coagulation factor deficiency that result in a lifelong bleeding disorder.

The individual has engaged in an act of sexual abuse to another individual within the past 90 days (or more, if delay occurs due to delayed discovery or legal system.) or patient has a history of having committed a sexual offense, is in outpatient treatment, and is demonstrating behavior suggesting to the treating clinician that new offending behavior is imminent.

L

On December 19, 2017 The US Food and Drug Administration (FDA) approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat a rare form of inherited vision loss that can lead to blindness.

M

Makena® (hydroxyprogesterone caproate injection) is a progestin medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Mechanical stretching devices are used for the prevention and treatment of joint contractures of the extremities, with the goal to maintain or restore range of motion (ROM) to the joint.

The neonatal risks of late preterm (34 0/7 – 36 6/7 weeks of gestation) and early-term (37 0/7 – 38 6/7 weeks of gestation) births are well established.

N

NMES involves the use of a device which transmits an electrical impulse to the skin over selected muscle groups by way of electrodes.

O

Multiple sclerosis (MS) is an immune-mediated disease in which an abnormal response of the body’s immune system is directed against the central nervous system, brain, spinal cord and optic nerves.

The term "feeding disorder" refers to a condition in which a patient is unable or refuses to eat, or has difficulty eating, resulting in failure to grow normally.

Orthognathic surgery is the surgical correction of abnormalities of the mandible, maxilla, or both.

Of the estimated 5.6 million fractures that occur annually in the United States, approximately 5% to 10% will demonstrate signs of delayed or impaired healing.

Optic nerve (ON) sheath decompression involves direct decompression (fenestration) of the ON sheaths just behind the globe. The approach and technique for an ON sheath fenestration varies. This policy describes the medical necessity requirements for ON decompression surgery.

P

Obstructive sleep apnea syndrome (OSAS) is a disorder of breathing in which prolonged partial upper airway obstruction and/or intermittent complete obstruction occurs during sleep disrupting normal ventilation and normal sleep patterns.

Amplification with hearing instruments should be considered for a child who demonstrates a significant hearing loss, including sensorineural, conductive, or mixed hearing losses of any degree.

Diabetes mellitus is characterized by hyperglycemia due to impaired pancreatic insulin secretion or inefficient use of insulin by the body.

Developmental disability is defined as an inability to perform age-appropriate functional skills as indicated by standard test scores less than 85, scaled score less than 7, percentile less than 16, Z-score less than −1.00 or developmental quotient (DQ) less than 80.2.

Mycosis fungoides and Sézary syndrome are diseases in which lymphocytes become malignant and affect the skin.

Prolastin-C is an Alpha1-Proteinase Inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary alpha1-antitrypsin deficiency.

Post–acute care refers to a wide range of services, which include skilled nursing facilities, inpatient rehabilitation facilities, home health aides, outpatient physical and occupational therapy, and long-term care facilities.

R

On May 5, 2017 The U.S. Food and Drug Administration approved Radicava® (edaravone) as a treatment for patients with ALS.

On October 15, 2018, the United States Food and Drug Administration (FDA) approved Revcovi™ (elapegademaselvlr), a second-generation medication therapy for ADA.

Reduction mammoplasty is the surgical reduction of breast size. It was developed as a means of alleviating physical and emotional symptoms associated with excessive breast size and breast ptosis.

HP Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Respite Care is short-term inpatient care provided to the individual only when necessary to relieve the family members or other persons caring for the individual at home.

Beneficiaries may have a combination of developmental, neurological and medical conditions necessitating the need for certain dental services to be provided in an operating room as an outpatient hospital service.

Reduction mammoplasty is the surgical reduction of breast size. It was developed as a means of alleviating physical and emotional symptoms associated with excessive breast size and breast ptosis.

S

Fecal incontinence is defined as the involuntary loss of solid or liquid feces.

Sclerotherapy is a minimally invasive procedure to diminish abnormally dilated and symptomatic veins.

Observation care is a well-defined set of specific, clinically appropriate services, which include ongoing short term treatment, assessment, and reassessment before a decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital.

Soliris® (eculizumab) is a complement inhibitor which inhibits the terminal part of the complement cascade, a part of the immune system that, when activated in an uncontrolled manner, plays a role in serious rare disorders like paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis (MG).

Speech therapy is the study, diagnosis and treatment of speech, language and communication in people of all ages to enable them to communicate to the best of their ability.

Stem-cell transplantation refers to the transplantation of hematopoietic stem cells (HSCs) into a patient.

According to the Centers for Medicare & Medicaid Services (CMS), chronic wounds of the lower extremities, including venous stasis ulcers (VSU), venous leg ulcers (VLU), Diabetic foot ulcers (DFU) and pressure sores, are a major public health problem.

Spinal Muscular Atrophy (SMA) disorders are characterized by degeneration of the anterior horn cells in the spinal cord and motor nuclei in the lower brainstem.

T

Telehealth and telemedicine are often used interchangeably; WellCare uses the following distinction

Implantable testosterone pellets may be indicated as second-line testosterone replacement therapy for males.

DiGeorge syndrome (DGS) is a disorder in which there is a defect in the development of the pharyngeal pouch system. The syndrome is most commonly caused by a chromosomal deletion at 22q11.2.

The health plan may implement directed quality improvement initiatives that require the coordination and use of community resources such as transportation services that may or may not be a component of the member’s benefit structure.

Nausea and vomiting of pregnancy, commonly known as “morning sickness,” affects approximately 80 percent of pregnant women.

Lymphedema is an accumulation of lymphatic fluid in the interstitial tissue, principally in the subcutaneous fatty issues.

Trogarzo™ (ibalizumab) is a humanized monoclonal antibody developed for the treatment of multidrug resistant HIV-1 infection.

U

V

Vagus nerve stimulation (VNS) has been used in the treatment of epilepsy and has been studied for the treatment of refractory depression and other indications

VANTAS® (histrelin implant) is a sterile, non-biodegradable, diffusion-controlled HYDRON® polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH), also known as luteinizing hormone releasing hormone (LH-RH), possessing a greater potency than the natural sequence hormone.

The artificial larynx, is frequently used to restore speech in post-laryngectomy patients. There are two types of artificial larynx devices: neck and intraoral. The neck type is placed against the skin on the side of the neck, under the chin, or on the cheek.

W

Wound care includes, but is not limited to ulcers, pressure ulcers, open surgical sites, fistulas, tube sites and tumor erosion sites when the skills of a licensed therapist, qualified wound care nurse, nurse or physician/physician extender are required to safely and effectively provide the care necessary for their treatment.

X

Z

Spinal Muscular Atrophy (SMA) disorders are characterized by degeneration of the anterior horn cells in the spinal cord and motor nuclei in the lower brainstem.

Medicare Clinical Coverage Guidelines (CCGs)

B

Johns Hopkins Health Library defines burns as a type of painful wound caused by thermal, electrical, chemical, or electromagnetic energy.

C

Chelation therapy is an established treatment for heavy metal poisoning.

The FDA assigns a special identifier number that corresponds to each device granted an investigational device exemption (IDE).

The American College of Physicians and the American Pain Society (ACP/APS) published a joint clinical guideline for the diagnosis and treatment of low back pain; spinal manipulation is recommended for patients who do not improve with self-care options.

D

Some medical conditions may result in a condition called lipoatrophy, characterized by facial wasting of fat under the skin of the face and other parts of the body.

Diaphragmatic/phrenic nerve stimulator devices are indicated for certain ventilator-dependent individuals who lack voluntary control of their diaphragm muscles to enable independent breathing without the assistance of a mechanical ventilator for at least four continuous hours a day.

Testing for drugs of abuse is performed to detect the use of prescription medications and illegal substances for the purpose of medical treatment.

The U.S. Food and Drug Administration (FDA) approved Duopa (a formula of carbidopa and levodopa) to treat a small subset of patients with advanced Parkinson’s disease.

A joint contracture is characterized by chronically reduced range of motion (ROM) secondary to structural changes in non-bony tissues including muscle, tendons, ligaments, and skin.

E

Evidence from the reviewed studies indicates that exhaled NO demonstrates moderate to good accuracy in diagnosing asthma and may be useful in predicting and monitoring inflammatory responses indicative of asthma exacerbation before and during anti-inflammatory treatment.

Sudden cardiac death (SCD) is typically defined as unanticipated death due to cardiac causes that occur within 1 hour of the onset of acute symptoms.

F

Uterine fibroids (or leiomyomas) are benign soft tissue neoplasms that arise from smooth muscle. These lesions can develop wherever smooth muscle is present, but malignant transformation probably does not occur.

G

Gender reassignment therapy, either as male-to-female transsexuals (transwomen) or as female-to-male transsexuals (transmen), consists of medical and surgical treatment that changes primary or secondary sex characteristics.

Diabetes mellitus is characterized by hyperglycemia due to impaired pancreatic insulin secretion or inefficient use of insulin by the body. Members with insulin-dependent (type 1) diabetes require chronic treatment with exogenous insulin.

Growth Hormone Deficiency (GHD) is a rare disorder characterized by the inadequate secretion of growth hormone (GH) from the anterior pituitary gland, a small gland located at the base of the brain that is responsible for the production of several hormones.

H

Hearing aids are electronic amplifying devices designed to bring sound more effectively into the ear.

J

Hemophilia A, factor VIII deficiency, is a recessive X-chromosome linked inherited coagulation factor deficiency that result in a lifelong bleeding disorder.

N

NMES involves the use of a device which transmits an electrical impulse to the skin over selected muscle groups by way of electrodes.

O

Multiple sclerosis (MS) is an immune-mediated disease in which an abnormal response of the body’s immune system is directed against the central nervous system, brain, spinal cord and optic nerves.

The term "feeding disorder" refers to a condition in which a patient is unable or refuses to eat, or has difficulty eating, resulting in failure to grow normally.

Orthognathic surgery is the surgical correction of abnormalities of the mandible, maxilla, or both.

Of the estimated 5.6 million fractures that occur annually in the United States, approximately 5% to 10% will demonstrate signs of delayed or impaired healing.

P

Post–acute care refers to a wide range of services, which include skilled nursing facilities, inpatient rehabilitation facilities, home health aides, outpatient physical and occupational therapy, and long-term care facilities.

Poteligeo® is considered medically necessary and a covered benefit for treatment of relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS)

The Peristeen® Anal Irrigation System is intended to instill water into the colon through a rectal catheter, which incorporates an inflatable balloon, inserted into the rectum to promote evacuation of the contents of the lower colon.

R

On May 5, 2017 The U.S. Food and Drug Administration approved Radicava® (edaravone) as a treatment for patients with ALS.

On October 15, 2018, the United States Food and Drug Administration (FDA) approved Revcovi™ (elapegademaselvlr), a second-generation medication therapy for ADA.

HP Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Beneficiaries may have a combination of developmental, neurological and medical conditions necessitating the need for certain dental services to be provided in an operating room as an outpatient hospital service.

S

Fecal incontinence is defined as the involuntary loss of solid or liquid feces.

There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure.

Speech therapy is the study, diagnosis and treatment of speech, language and communication in people of all ages to enable them to communicate to the best of their ability.

T

Implantable testosterone pellets may be indicated as second-line testosterone replacement therapy for males.

The health plan may implement directed quality improvement initiatives that require the coordination and use of community resources such as transportation services that may or may not be a component of the member’s benefit structure.

Lymphedema is an accumulation of lymphatic fluid in the interstitial tissue, principally in the subcutaneous fatty issues.

U

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare hematopoietic stem cell disorder of the X chromosome. It is estimated that there are as many as 1 to 10 cases per million, however, it is thought that many cases go undiagnosed.

V

VANTAS® (histrelin implant) is a sterile, non-biodegradable, diffusion-controlled HYDRON® polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH), also known as luteinizing hormone releasing hormone (LH-RH), possessing a greater potency than the natural sequence hormone.

W

Wound care includes, but is not limited to ulcers, pressure ulcers, open surgical sites, fistulas, tube sites and tumor erosion sites when the skills of a licensed therapist, qualified wound care nurse, nurse or physician/physician extender are required to safely and effectively provide the care necessary for their treatment.

X

Each year in the United States, more than 30,000 patients undergo back surgery for lumbar spinal stenosis, an abnormal narrowing or constriction of spaces in the back that provide pathways for spinal nerves.

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Last Updated On: 11/20/2020