Thursday, February 23, 2017

CPT 95811, G0399, 95803 - Home sleep testing

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

G0398 HOME SLEEP STUDY TEST (HST) WITH TYPE II PORTABLE MONITOR, UNATTENDED; MINIMUM OF 7 CHANNELS: EEG, EOG, EMG, ECG/HEART RATE, AIRFLOW, RESPIRATORY EFFORT AND OXYGEN SATURATION

G0399 HOME SLEEP TEST (HST) WITH TYPE III PORTABLE MONITOR, UNATTENDED; MINIMUM OF 4 CHANNELS: 2 RESPIRATORY MOVEMENT/AIRFLOW, 1 ECG/HEART RATE AND 1 OXYGEN SATURATION

G0400 HOME SLEEP TEST (HST) WITH TYPE IV PORTABLE MONITOR, UNATTENDED; MINIMUM OF 3 CHANNELS

Group 2 Paragraph: CPT/HCPCS Codes Not Covered:


Group 2 Codes:

95803 ACTIGRAPHY TESTING, RECORDING, ANALYSIS, INTERPRETATION, AND REPORT (MINIMUM OF 72 HOURS TO 14 CONSECUTIVE DAYS OF RECORDING)

95811 POLYSOMNOGRAPHY; AGE 6 YEARS OR OLDER, SLEEP STAGING WITH 4 OR MORE ADDITIONAL PARAMETERS OF SLEEP, WITH INITIATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY OR BILEVEL VENTILATION, ATTENDED BY A TECHNOLOGIST



Coverage Indications, Limitations, and/or Medical Necessity

Sleep disorder clinics are facilities in which certain conditions are diagnosed through the study of sleep. Such clinics are for diagnosis, therapy, and research. Sleep disorder clinics may provide some diagnostic or therapeutic services which are covered under Medicare. These clinics may be affiliated either with a hospital or a freestanding facility. Whether a clinic is hospital-affiliated or freestanding, coverage for diagnostic services under some circumstances is covered under provisions of the law different from those for coverage of therapeutic services. (CMS publication 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 70)

The physician services related to home sleep testing are covered for the purpose of testing a patient for the diagnosis of obstructive sleep apnea if the home sleep testing is reasonable and necessary for the diagnosis of the patient’s condition, meets all other Medicare requirements, and the physician who performs the service has sufficient training and experience to reliably perform the service.

A home sleep test is covered only when it is performed in conjunction with a comprehensive sleep evaluation and in patients with a high pretest probability of moderate to severe obstructive sleep apnea.

Home sleep testing is not covered for persons with comorbidities (moderate to severe pulmonary disease, neuromuscular disease or congestive heart failure).

Home Sleep studies are only covered for the diagnosis of Obstructive Sleep Apnea. They are not covered for any other sleep disorders (central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, circadian rhythm disorders or narcolepsy) or for screening asymptomatic persons.


A. Medical Conditions for Which Testing is Covered

Sleep Apnea- Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation. This is a potentially lethal condition where the patient stops breathing during sleep. Three types of sleep apnea have been described (central, obstructive, and mixed). The nature of the apnea episodes can be documented by appropriate diagnostic testing.(CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 70).

Obstructive Sleep Apnea (OSA) is the collapse of the oropharyngeal walls and the obstruction of airflow occurring during sleep.

CMS PUB 100-03 NCD; 240.4.1 – Sleep Testing for Obstructive Sleep Apnea (OSA) finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA:

B. Covered Home Sleep Testing Devices

1. Type II sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA.
Type II monitors have a minimum of 7 channels (e.g., EEG, EOG, EMG, ECG-heart rate, airflow, breathing/respiratory effort, SaO2)-this type of device monitors sleep staging, so AHI can be calculated).

2. Type III sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA.
Type III monitors have a minimum of 4 monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation.

3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA.

Type IV devices may measure one, two, three or more parameters but do not meet all the criteria of a higher category device.

Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab
facility or attended in a sleep lab facility.


C. Physician and Technician Requirements for Home Sleep Testing:

The physician performing the service must meet one of the following:
be a diplomate of the American Board of Sleep Medicine (ABSM) and
Board Certified Pulmonologist, or a Board Certified Neurologist or

has a Sleep Certification issued by one of the following Boards:
American Board of Internal Medicine (ABIM),
American Board of Family Medicine (ABFM),
American Board of Pediatrics (ABP),
American Board of Psychiatry and Neurology (ABPN),
American Board of Otolaryngology (ABOto),
American Osteopathic Board of Neurology and Psychiatry (AOBNP),
American Osteopathic Board of Family Medicine, (AOBFP)
American Osteopathic Board of Internal Medicine, (AOBIM)
American Osteopathic Board of Ophthalmology and Otorhinolaryngology (AOBOO), or

be an active staff member of an accredited sleep center or laboratory. The sleep facility accreditation must be from the American Academy of Sleep Medicine (AASM), inpatient or outpatient, or the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation for Ambulatory care sleep centers.


Technician Credentials

The technician performing the service must meet one of the following:

American Board of Sleep Medicine (ABSM)
Registered Sleep Technologist (RST)

Board of Registered Polysomnographic Technologists (BRPT):
Registered Polysomnographic Technologist (RPSGT)

National Board for Respiratory Care (NBRC):
Certified Pulmonary Function Technologist (CPFT)
Registered Pulmonary Function Technologist (RPFT)
Certified Respiratory Therapist (CRT)
Registered Respiratory Therapist (RRT)

All centers billing sleep studies must maintain proper certification/ accreditation documentation as defined above, which include: Accreditation of sleep centers to include—AASM, or Joint Commission.


D. Actigraphy Testing:

Actigraphy measures movement of a limb. It can be measured as part of a sleep test but will not be paid for separately.

E. Home Sleep Testing (HST) is not covered in the following situations:

for the diagnosis of patients with chronic insomnia;
to preoperatively evaluate a patient undergoing a laser assisted uvulopalatopharyngoplasty without clinical evidence that obstructive sleep apnea is suspected;
to diagnose chronic lung disease (Nocturnal hypoxemia in patients with chronic, obstructive, restrictive, or reactive lung disease is usually adequately evaluated by oximetry. However, if the patient's symptoms suggest a diagnosis of obstructive sleep apnea, polysomnography is considered medically necessary);
in cases where seizure disorders have not been ruled out;
in cases of typical, uncomplicated, and non-injurious parasomnias when the diagnosis is clearly delineated
for patients with epilepsy who have no specific complaints consistent with a sleep disorder
for patients with symptoms suggestive of the periodic limb movement disorder or restless leg syndrome unless symptoms are suspected to be related to a covered indication
for the diagnosis of insomnia related to depression
for the diagnosis of circadian rhythm sleep disorders [i.e., rapid time-zone change (jet lag), shift-work sleep disorder, delayed sleep phase syndrome, advanced sleep phase syndrome, and non 24-hour sleep wake disorder].

Criteria for Coverage of Diagnostic Tests

All reasonable and necessary diagnostic tests given for the medical conditions listed in subsection B are covered when the following criteria are met:

The clinic is either affiliated with a hospital or is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder clinics may be covered even in the absence of direct supervision by a physician;

Patients are referred to the sleep disorder clinic by their attending physicians, and the clinic maintains a record of the attending physician’s orders; and

The need for diagnostic testing is confirmed by medical evidence, e.g., physician examinations and laboratory tests.

Diagnostic testing that is duplicative of previous testing done by the attending physician to the extent the results are still pertinent is not covered because it is not reasonable and necessary under §1862(a)(1)(A) of the Act.


Home sleep studies/home sleep test may be considered medically necessary in adult patients (>18years of age) who are at high pre-test probability for moderate to severe obstructive sleep apnea (OSA), when ALL of the following criteria are met:

Patients considered high pre-test probability for moderate to severe OSA must have at least two of the following:
*Habitual snoring or gasping/choking episodes associated with awakenings;
*Observed apneas;
Excessive daytime sleepiness as evidenced by one of the following:
Questionnaires (Epworth Sleepiness Scale >10, Berlin, Wisconsin, STOP or STOP BANG)
Inappropriate day time napping (e.g. during driving, conversation or eating), or
sleepiness that interferes with daily activities not explained by other conditions;
A body mass index > 30 kg/m2;
Increased neck circumference >17 inches for men or >16 inches in women;
Morning headaches;
Sleep fragmentation or frequent unexplained arousals from sleep;
Decreased concentration/memory loss;
Treatment resistant hypertension/unexplained hypertension.
*If no bed partner is available to report snoring or observed apneas, the patient must still meet the criteria as it relates to other signs and symptoms suggestive of OSA.

AND

In addition, those patients eligible for an unattended home sleep study must have no evidence of a co-morbid medical condition including but not limited to any of the following as they might alter ventilation or require alternative treatment;
Moderate to Severe Pulmonary Disease
Congestive Heart Failure
Obesity hypoventilation syndrome
Neuromuscular disease (Parkinson’s, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis).


AND

Must not be suspected of having other sleep disorders including but not limited to the following;
Central sleep apnea
Periodic limb movement disorder
Restless leg syndrome
Insomnia
Parasomnias
Narcolepsy.


AND

Any one of the following sleep monitoring devices;
sleep monitoring using a Type II device; or
sleep monitoring using a Type III device; or
sleep monitoring using a Type IV(A) device, which must measure a minimum of three channels and must provide measurement of apnea-hypopnea index (AHI).

Unsupervised (unattended) home sleep studies/home sleep testing for an asymptomatic individual is considered not medically necessary.

Sleep studies using devices that do not provide a measurement of apnea-hypopnea index (AHI) and oxygen saturation are considered not medically necessary because they do not provide sufficient information to prescribe treatment.


Notes

See Description information above for a full description of sleep monitoring devices.
Respiratory disturbance index (RDI) may be used in place of apnea/hypopnea index (AHI) in unattended sleep studies.

Unsupervised (unattended) home sleep study/home sleep test is typically performed over multiple nights with a single interpretation and is considered a single sleep study for purposes of reimbursement.

When a diagnosis of OSA is established following a home sleep study/home sleep test (portable study), home titration to determine a fixed CPAP pressure can be effectively completed using auto-titrating positive airway pressure. Evidence from several well-designed trials demonstrates that home PAP titration using APAP compared to in-facility titration results in similar outcomes in terms of improvement in AHI, Epworth Sleepiness scores, and CPAP acceptance and adherence. Therefore laboratory CPAP titration following unattended or home sleep testing is not considered medically necessary.


Repeat unsupervised (unattended) home sleep studies/home sleep testing may be considered medically necessary in adult patients for any of the following reasons;

To assess efficacy of surgery or oral appliances/devices.
A non-diagnostic home study within the past 3 months (e.g. technical complications or negative test with a high pretest probability of OSA).
Failure of resolution of symptoms or recurrence of symptoms during treatment.
To re-evaluate the diagnosis of OSA and need for continued PAP therapy (e.g. if there is a significant change in weight or change in symptoms suggesting that PAP therapy should be adjusted or possibly discontinued).



Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
N/A


ICD-10 Codes that Support Medical Necessity


ICD-10 CODE DESCRIPTION

G47.10 Hypersomnia, unspecified

G47.13 Recurrent hypersomnia

G47.14 Hypersomnia due to medical condition

G47.19 Other hypersomnia

G47.30 Sleep apnea, unspecified

G47.33 Obstructive sleep apnea (adult) (pediatric)

Friday, January 20, 2017

CPT CODE 82306, 82652 - Vitamin D Hydroxy

Procedure Codes and Description

Group 1 Paragraph: Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural (CPT) codes.

Group 1 Codes:
82306 VITAMIN D; 25 HYDROXY, INCLUDES FRACTION(S), IF PERFORMED
82652 VITAMIN D; 1, 25 DIHYDROXY, INCLUDES FRACTION(S), IF PERFORMED

Coverage Indications, Limitations, and/or Medical Necessity

Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay.

Indications:

Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with:

chronic kidney disease stage III or greater

cirrhosis

hypocalcemia

hypercalcemia

hypercalciuria

hypervitaminosis D

parathyroid disorders

malabsorption states

obstructive jaundice

osteomalacia

osteoporosis if
i. T score on DEXA scan <-2 .5="" nbsp="" or="" p="">ii. History of fragility fractures or
iii. FRAX > 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or
iv. FRAX > 3% (any fracture) with T-score <-1 .5="" or="" p="">v. Initiating bisphosphanate therapy (Vit D level should be determined and managed as necessary before bisphosphonate is initiated)

osteosclerosis/petrosis

rickets

vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment.

Measurement of 1, 25-OH Vitamin D, CPT 82652, level is indicated for patients with:

unexplained hypercalcemia (suspected granulomatous disease or lymphoma)

unexplained hypercalciuria (suspected granulomatous disease or lymphoma)

suspected genetic childhood rickets

suspected tumor-induced osteomalacia

nephrolithiasis or hypercalciuria

Limitations:

Testing may not be used for routine or other screening.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1,25 dihydroxy vitamin D deficiency exists; mostly, in those with renal disease. Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH vitamin D, such as stored D or diet-derived D, should not be billed separately.

Once a beneficiary has been shown to be vitamin D deficient, further testing may be medically necessary only to ensure adequate replacement has been accomplished. If Vitamin D level is between 20 and 50 ng/dl and patient is clinically stable, repeat testing is often unnecessary; if performed, documentation most clearly indicate the necessity of the test. If level <20 dl="" ng="" or=""> 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
014x Hospital - Laboratory Services Provided to Non-patients
018x Hospital - Swing Beds
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0300 Laboratory - General Classification
0301 Laboratory - Chemistry
0309 Laboratory - Other Laboratory





ICD-10 Codes that Support Medical Necessity


ICD-10 CODE DESCRIPTION

E20.0 Idiopathic hypoparathyroidism
E20.8 Other hypoparathyroidism
E20.9 Hypoparathyroidism, unspecified
E21.0 Primary hyperparathyroidism
E21.1 Secondary hyperparathyroidism, not elsewhere classified
E21.2 Other hyperparathyroidism
E21.3 Hyperparathyroidism, unspecified
E41 Nutritional marasmus
E43 Unspecified severe protein-calorie malnutrition
E55.0 Rickets, active
E55.9* Vitamin D deficiency, unspecified
E67.3 Hypervitaminosis D
E83.30 Disorder of phosphorus metabolism, unspecified
E83.31 Familial hypophosphatemia
E83.32 Hereditary vitamin D-dependent rickets (type 1) (type 2)
E83.39 Other disorders of phosphorus metabolism
E83.50* Unspecified disorder of calcium metabolism
E83.51 Hypocalcemia
E83.52 Hypercalcemia
E89.2 Postprocedural hypoparathyroidism
E89.820 Postprocedural hematoma of an endocrine system organ or structure following an endocrine system procedure
E89.821 Postprocedural hematoma of an endocrine system organ or structure following other procedure
E89.822 Postprocedural seroma of an endocrine system organ or structure following an endocrine system procedure
E89.823 Postprocedural seroma of an endocrine system organ or structure following other procedure
K74.1 Hepatic sclerosis
K74.2 Hepatic fibrosis with hepatic sclerosis
K76.9 Liver disease, unspecified
K90.0 Celiac disease
K90.1 Tropical sprue
K90.2 Blind loop syndrome, not elsewhere classified
K90.3 Pancreatic steatorrhea
K90.41 Non-celiac gluten sensitivity
K90.49 Malabsorption due to intolerance, not elsewhere classified
K90.89 Other intestinal malabsorption
K90.9 Intestinal malabsorption, unspecified
K91.2 Postsurgical malabsorption, not elsewhere classified
M81.0 Age-related osteoporosis without current pathological fracture
M81.8 Other osteoporosis without current pathological fracture
M83.0 Puerperal osteomalacia
M83.1 Senile osteomalacia
M83.2 Adult osteomalacia due to malabsorption
M83.3 Adult osteomalacia due to malnutrition
M83.4 Aluminum bone disease
M83.5 Other drug-induced osteomalacia in adults
M83.8 Other adult osteomalacia
M83.9 Adult osteomalacia, unspecified
M85.80 Other specified disorders of bone density and structure, unspecified site
M85.88 Other specified disorders of bone density and structure, other site
N18.3 Chronic kidney disease, stage 3 (moderate)
N18.4 Chronic kidney disease, stage 4 (severe)
N18.5 Chronic kidney disease, stage 5
N18.6 End stage renal disease
N25.81 Secondary hyperparathyroidism of renal origin
Q78.2 Osteopetrosis
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: E55.9* If more than one LCD-listed condition contributes to Vit. D deficiency in a given patient and/or is improved by Vit. D administration, coders should use: ICD-10 E55.9 UNSPECIFIED VITAMIN D DEFICIENCY.This code should not be used for any other indication.

E83.50* Use only for HYPERCALCIURIA
t

Group 2 Paragraph: The following ICD-10-CM codes support the medical necessity of CPT code 82652

Group 2 Codes:
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Group 2Codes

ICD-10 CODE DESCRIPTION
E55.0 Rickets, active
E55.9 Vitamin D deficiency, unspecified
E83.50* Unspecified disorder of calcium metabolism
E83.52* Hypercalcemia
M83.0 Puerperal osteomalacia
M83.1 Senile osteomalacia
M83.2 Adult osteomalacia due to malabsorption
M83.3 Adult osteomalacia due to malnutrition
M83.4 Aluminum bone disease
M83.5 Other drug-induced osteomalacia in adults
M83.8 Other adult osteomalacia
M83.9 Adult osteomalacia, unspecified
N20.0 Calculus of kidney
N20.1 Calculus of ureter
N20.2 Calculus of kidney with calculus of ureter
N20.9 Urinary calculus, unspecified
N22 Calculus of urinary tract in diseases classified elsewhere
Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: M83.9* Use only for tumor-induced osteomalacia
E83.50* Use only for unexplained hypercalciuria
E83.52* Use only for unexplained hypercalcemia
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Additional ICD-10 Information
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Saturday, January 14, 2017

CPT code j1569, j1459, J1572, J1599 - Injection immune globulin

Procedure codes and Description

J1459 INJECTION, IMMUNE GLOBULIN (PRIVIGEN), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1556 INJECTION, IMMUNE GLOBULIN (BIVIGAM), 500 MG

J1557 INJECTION, IMMUNE GLOBULIN, (GAMMAPLEX), INTRAVENOUS, NON-
LYOPHILIZED (E.G., LIQUID), 500 MG

J1561 INJECTION, IMMUNE GLOBULIN, (GAMUNEX-C/GAMMAKED), NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1566 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G., POWDER), NOT OTHERWISE SPECIFIED, 500 MG

J1568 INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1569 INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), NON-LYOPHILIZED, (E.G., LIQUID), 500 MG

J1572 INJECTION, IMMUNE GLOBULIN, (FLEBOGAMMA/FLEBOGAMMA DIF), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1599 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG



Coverage Indications, Limitations, and/or Medical Necessity

Note: Providers should seek information related to National Coverage Determinations (NCD) and other Centers for Medicare & Medicaid Services (CMS) instructions in CMS Manuals. This LCD only pertains to the contractor's discretionary coverage related to this drug.

IVIg is a solution of human immunoglobulins specifically prepared for intravenous infusion. Immunoglobulin contains a broad range of antibodies that specifically act against bacterial and viral antigens.

There may be acceptable off-label uses for IVIg in rare patient populations or in rare individual patient clinical scenarios which are not covered by this LCD. In such instances, a request for an individual patient consideration by the Medical Director should accompany the appeal of any denied claim.

There are several off-label uses for IVIg, especially in neurological disorders. There is good scientific evidence that supports use in a few of the disorders; in others, however, the evidence is either poor or absent. This policy addresses the off-label uses of IVIg in certain neurological conditions, and idiopathic thrombocytopenic purpura (ITP) in pregnancy. It also clarifies the conditions under which certain FDA-approved uses may be covered. This policy does not address the use of IVIg in any condition covered by a National Coverage Determination (NCD) or CMS manual instruction. (See attached article)

Idiopathic Thrombocytopenic Purpura (ITP) in Pregnancy:

Pregnant women with this disease are at risk for delivering thrombocytopenic infants. Protection of the fetus becomes an important consideration in management of a pregnant woman with immune thrombocytopenic purpura. IVIg may be recommended in the following:

1. Pregnant women who have previously delivered infants with autoimmune thrombocytopenia;
2. Pregnant women who have platelet counts less than 75,000/mm3 during the current pregnancy; or
3. Pregnant women with past history of splenectomy


In the presence of one of the above indications, the use of IVIg may be covered if one of the following situations is present:

Failure of or contraindications to other therapy; and/or

Rapidly progressive form of the disease;

All the conditions listed below (see Neurological Disorders) for Medicare coverage are met.

Neurological Disorders:
The use of IVIg in some neurological conditions has been associated with demonstrable clinical benefit. Studies with acceptable methodological bases have shown that IVIg may halt and/or reverse disease progression in Myasthenia Gravis, Guillain-Barre Syndrome and Chronic Inflammatory Demyelinating Neuropathy (CIDP). In a few neurological conditions, such as Polymyositis, Multiple Myeloma, Multifocal Motor Neuropathy (MMN), Dermatomyositis and Lambert-Eaton myasthenic syndrome, IVIg may be of benefit.

Medicare may provide coverage for the use of IVIg use in the above disease conditions if the following requirements are met.

For Guillain-Barre, Myasthenia Gravis, Acute or Chronic Inflammatory Demyelinating Neuropathy (see CIDP below for additional criteria), Dermatomyositis, and Relapsing-Remitting Multiple Sclerosis (MS), the use of IVIg may be covered if one of the following scenarios is present:

Failure of or contraindications to other therapy (absolute requirement for Dermatomyositis and MS); and/or

Rapidly progressive form of the disease.


The diagnosis of the disorder must be reasonably certain, based on a thorough history and examination as well as, when necessary, electromyography (EMG), spinal fluid tests, serum tests and biopsy findings.

The clinical record must document the medical necessity to initiate IVIg therapy, and the ongoing need as long as treatment continues. The reasons for prescribing IVIg must be clear and include all required information. For example, previous treatment failures must be recorded.

Once treatment is initiated, documentation of progress must be meticulous. If there is initial improvement and continued treatment is necessary, then some type of quantitative assessment to monitor and document the progress is required. Quantitative monitoring may include any accepted metric assessment such as MRC scale and activities of daily living (ADL) measurements. Changes in these measures must be clearly documented. Subjective or experiential improvement alone is insufficient to either continue IVIg or to expect coverage.

Clinical monitoring takes precedence over laboratory monitoring. If significant clinical improvement is evident, then laboratory monitoring, solely to guide IVIg therapy, is not medically necessary.

When improvement has occurred, attempts to decrease/wean the dosage must be made and documented. Following dosage reduction, if improvement is sustained, an attempt to discontinue IVIg must be made. If documentable improvement does not occur with IVIg administration, then infusions should not continue.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and its variants (multifocal motor neuropathy, multifocal acquired demyelinating polyneuropathy, multifocal motor neuropathy, pure sensory CIDP).

CIDP is an autoimmune disorder caused by an attack on peripheral nervous system myelin. Clinically CIDP follows a subacute onset of weakness and/or sensory loss, evolving progressively, or in a stepwise fashion, over several months. Reflexes are usually decreased or absent. Electrodiagnostic testing (EDX) reveals the classic features of demyelination, with prolonged distal latencies, conduction slowing, prolonged F-waves, conduction block, and temporal dispersion in most cases. Most patients have an elevated spinal fluid protein level. (Jonathan S. Katz, MD, Dept. of Neurology, Stanford University)

Chronic progressive painful peripheral sensory neuropathy, which is common with diabetes mellitus or toxins, may eventually show demyelinating features on electrodiagnostic testing. Typically, these cases have progressed for more than one year prior to electrodiagnostic testing. Many patients with CIDP are not seen until several years into their illness.

In patients with sensory or sensorimotor polyneuropathies, when a CIDP diagnosis is uncertain, a response to a therapeutic trial of prednisone (e.g. 30-60 mg/d or perhaps 50-100 mg/d for 2-4 months with a taper) should be helpful to increase the specificity of the diagnosis in order to help assure that IVIg will be effective. In the absence of other supporting information, a subjective response to a therapeutic trial of IVIg is not sufficient to validate the diagnosis of CIDP. The principal goal of the treatment is to improve motor function in most patients.

If a diagnosis of multifocal motor neuropathy is suspected, a trial of IVIg is recommended since this condition does not respond to prednisone.

Specific diagnostic criteria for CIDP should include:

In typical CIDP, symmetrical muscle weakness affects proximal and distal muscles of all four limbs. Sensory loss may affect the distal limbs and usually involves large fiber modalities. The clinical evolution tends to be gradually progressive, evolving over periods of more than 8 weeks although patients typically present to clinicians within 6 months of onset. Decreased or absent reflexes in affected nerve distributions occur in nearly all CIDP presentations, and develop during the acute phase typically within 8 weeks of symptom onset. The patient should have a neurologic function assessment score of at least 3 or greater on the Rankin Scale at the time of initial therapy. However, IVIg can be used in patients with rapidly worsening weakness regardless of the Rankin score.

A multifocal variant of CIDP (multifocal acquired demyelinating sensory and motor neuropathy or MADSAM) leads to sensory and motor dysfunction in multiple individual nerve distributions (for example, ulnar or median). Weakness may affect the upper or lower limbs, but it most commonly affects distal musculature and is more common in the hands. Progression tends to be step-wise with episodes of weakness compiling over time to cause gradually increasing debility.

Multifocal motor neuropathy (MMN) is a purely motor syndrome that tends to affect the hands. Like MADSAM, the weakness affects the distribution of individual nerves and tends to progress in a step-wise fashion over time. Patients may have subjective sensory complaints but objective sensory findings are not present. The diagnosis is generally made using motor and sensory nerve conduction studies. MMN responds to IVIg but not to Prednisone. Therefore, Prednisone is never indicated in this condition.

Occasionally, a patient with CIDP may have only sensory symptoms. The sensory loss may affect the upper or lower limbs and tends to be relatively symmetrical. Like more common sensory-motor CIDP presentations, patients typically seek medical attention within 6-9 months from onset. The sensory loss may begin relatively acutely and progresses in a stepwise or gradual fashion. The sensory distribution is usually not simply limited to the feet or in a stocking distribution, but takes on unusual patterns involving the trunk, arms, or proximal legs. The condition is rare compared with the relatively common purely sensory neuropathies such as distal diabetic, toxic, alcoholic, and idiopathic neuropathies. Pure sensory CIDP also must be distinguished from distal demyelinating neuropathies associated with an IgM paraprotein, which is not responsive to IVIg or prednisone.

Laboratory evidence of CIDP includes:


o Conduction block at sites not prone to nerve compression.

o Motor nerves characteristically show segmental conduction slowing and increased distal latencies consistent with a demyelinating polyneuropathy. This is present in typical CIDP, MADSAM, MMN, and purely sensory CIDP.

o Conduction slowing from a demyelinating neuropathy should be distinguished from conduction slowing secondary to moderate to severe axonal loss.

o Cytoalbuminologic dissociation in more than 90% of cases.

Serum tests may show:

o An IgG monoclonal gammopathy (e.g. on immunofixation electrophoresis); however, an IgM monoclonal gammopathy places the diagnosis in question.

o An elevation of a specific antibody to GM-1 increases the likelihood of MMN. Antibodies to myelin associated glycoprotein (MAG) or sulfatide may occur in patients with demyelinating neuropathies besides CIDP and place the diagnosis in question.

No other explanation for the diagnosis, such as

o HIV disease;

o Distally predominant diabetic neuropathy;

o Diabetic amyotrophy;

o Diabetic cachectic neuropathy;

o Distal acquired demyelinating symmetric neuropathy with an IgM paraprotein; or

No evidence of another treatable cause of the polyneuropathy;

No evidence of hereditary demyelinating neuropathy.

Special consultation recommendations for IVIg use for CIDP, CIDP variants, and MMN:

Before beginning the initial treatment (i.e. the induction dose) for CIDP, or, for patients currently on treatment for CIDP within 3 months of the effective date of this policy, a consultation is expected from a neurologist or rheumatologist who is an expert in the field of CIDP. This will help validate the diagnosis is correct and the IVIg treatment is reasonable and necessary. The consultation should include a comprehensive history and examination as defined in the CPT book, validate the diagnosis of CIDP, and clarify the need for IVIg treatment. The consultation should set forth the recommended treatment regimen, appropriate measures of therapeutic benefit, and any recommendation for follow-up consultation.

If the indication for IVIg treatment is principally for pain control in a patient with presumed CIDP predominantly affecting the sensory nerves, before beginning the initial treatment (i.e. the induction dose), the patient should have shown a measurable response to a therapeutic trial of prednisone. In addition, the consultation from a neurologist or rheumatologist who is an expert in the field of CIDP is expected. This consultation should help validate the need for IVIg treatment for pain control as opposed to other pain treatment options that do not include IVIg.

IVIg for CIDP following the initial treatment regimen:

Once treatment is initiated, the benefit of treatment must be measured. Quantitative monitoring may use any accepted metric as MRC scale and activities of daily living (ADL) measurements.

Subsequent treatment with IVIg will be covered only when the patient demonstrates significant improvement in clinical condition and, when relevant, a reduction in the level of sensory loss. For long-term treatment of stable patients, the dose must be periodically reduced or withdrawn, and the effects measured, in order to validate continued use.

There is no reimbursement for the use of IVIg in the treatment of the following neurological disorders: epilepsy, Amyotrophic Lateral Sclerosis (ALS), paraneoplastic neurological syndromes, undiagnosed neuropathy or weakness and malignancies with no casual link to coexisting neurological dysfunctions.

The use of IVIg should be reserved for patients with serious defects of antibody function. The goal is to provide immune globulin to those who lack it. The following are certain FDA approved indications for IVIg, which are covered by Noridian.

Acute ITP:

Management of acute bleeding due to severe thrombocytopenia (platelet counts less than 30,000/mm3);

To increase platelet counts prior to invasive major surgical procedures (splenectomy); or

In patients with severe thrombocytopenia (platelet counts less than 20,000/mm3) considered to be at risk for intracerebral hemorrhage.


Chronic Refractory ITP:

First line treatment

o Pediatric ITP;
o In combination with steroids if rapid platelet response justified or to avoid splenectomy; or
o Contraindications to steroids

Second line treatment

o Following treatment with corticosteroids with splenectomy; or
o Platelet counts persistently at or below 20,000/mm 3.

Symptomatic Human Immunodeficiency Virus (HIV):

Indications for intravenous immunoglobulin would include:

1. Patients less than 13 years of age;
2. Entry CD4+ lymphocyte counts greater than or equal to 200/mm3; and
3. Clinically symptomatic or asymptomatic, but immunologically abnormal

Other Disorders:

a. Chronic Lymphocytic Leukemia with associated hypogammaglobulinemia. To initiate IVIg for this disease, the IgG level should be less than 600 mg/dl or there should be evidence of specific antibody deficiency and the presence of repeated bacterial infections.
b. Bone Marrow/Stem Cell Transplantation

o Transplantation must have been for a Medicare covered indication;

o Patients 20 years of age or older;

o Cytomegalovirus (CMV) seropositive before transplantation; or

o Cytomegalovirus (CMV) seronegative, had seropositive marrow donors, and were undergoing allogenic transplantation for hematologic neoplasms.

c. Kawasaki Disease (Mucocutaneous Lymph Node Syndrome)
d. Transplantation rejection, kidney or stem cell, antibody-mediated.
e. Autoimmune retinopathy (limited to three months unless there is improvement on therapy).

Immunoglobulin Deficiencies:
Individuals with agammaglobulinemia or hypogammaglobulin need lifelong antibody replacement, however, Ig replacement is unlikely to be necessary until the IgG levels fall below 200 mg/dl.


Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
085x Critical Access Hospital

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
The Section titled “Does the 'CPT 30% Rule' Apply?” needs clarification. This rule comes from the AMA (American Medical Association), the organization that holds the copyrights for all CPT codes. The rule states that if, in a given section (e.g., surgery) or subsection (e.g., surgery, integumentary) of CPT Manual, more than 30% of the codes are listed in the LCD, then the short descriptors must be used rather than the long descriptors found in the CPT Manual.
0636 Pharmacy - Drugs Requiring Detailed Coding





ICD-10 Codes that Support Medical Necessity


Group 1Codes

ICD-10 CODE DESCRIPTION
B20* Human immunodeficiency virus [HIV] disease
B25.0 Cytomegaloviral pneumonitis
B25.1 Cytomegaloviral hepatitis
B25.2 Cytomegaloviral pancreatitis
B25.8 Other cytomegaloviral diseases
C90.00 Multiple myeloma not having achieved remission
C90.02 Multiple myeloma in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
D59.0 Drug-induced autoimmune hemolytic anemia
D59.1 Other autoimmune hemolytic anemias
D61.01* Constitutional (pure) red blood cell aplasia
D69.3 Immune thrombocytopenic purpura
D69.42 Congenital and hereditary thrombocytopenia purpura
D69.49 Other primary thrombocytopenia
D80.0 Hereditary hypogammaglobulinemia
D80.1 Nonfamilial hypogammaglobulinemia
D80.5 Immunodeficiency with increased immunoglobulin M [IgM]
D81.0 Severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1 Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
D81.2 Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
D81.6 Major histocompatibility complex class I deficiency
D81.7 Major histocompatibility complex class II deficiency
D81.89 Other combined immunodeficiencies
D81.9 Combined immunodeficiency, unspecified
D82.0 Wiskott-Aldrich syndrome
D83.0 Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
D83.2 Common variable immunodeficiency with autoantibodies to B- or T-cells
D83.8 Other common variable immunodeficiencies
D83.9 Common variable immunodeficiency, unspecified
G25.82 Stiff-man syndrome
G35 Multiple sclerosis
G60.3 Idiopathic progressive neuropathy
G61.0 Guillain-Barre syndrome
G61.81* Chronic inflammatory demyelinating polyneuritis
G61.82 Multifocal motor neuropathy
G65.0 Sequelae of Guillain-Barre syndrome
G70.00 Myasthenia gravis without (acute) exacerbation
G70.01 Myasthenia gravis with (acute) exacerbation
G70.81 Lambert-Eaton syndrome in disease classified elsewhere
G73.1 Lambert-Eaton syndrome in neoplastic disease
G73.3 Myasthenic syndromes in other diseases classified elsewhere
M30.3 Mucocutaneous lymph node syndrome [Kawasaki]
M31.1 Thrombotic microangiopathy
M33.00 Juvenile dermatopolymyositis, organ involvement unspecified
M33.01 Juvenile dermatopolymyositis with respiratory involvement
M33.02 Juvenile dermatopolymyositis with myopathy
M33.09 Juvenile dermatopolymyositis with other organ involvement
M33.10 Other dermatopolymyositis, organ involvement unspecified
M33.11 Other dermatopolymyositis with respiratory involvement
M33.12 Other dermatopolymyositis with myopathy
M33.19 Other dermatopolymyositis with other organ involvement
M33.20 Polymyositis, organ involvement unspecified
M33.21 Polymyositis with respiratory involvement
M33.22 Polymyositis with myopathy
M33.29 Polymyositis with other organ involvement
M33.90 Dermatopolymyositis, unspecified, organ involvement unspecified
M33.91 Dermatopolymyositis, unspecified with respiratory involvement
M33.92 Dermatopolymyositis, unspecified with myopathy
M33.99 Dermatopolymyositis, unspecified with other organ involvement
M34.83 Systemic sclerosis with polyneuropathy
M36.0 Dermato(poly)myositis in neoplastic disease
T86.01 Bone marrow transplant rejection
T86.02 Bone marrow transplant failure
T86.09 Other complications of bone marrow transplant
T86.11 Kidney transplant rejection
T86.12 Kidney transplant failure
T86.19 Other complication of kidney transplant
T86.5 Complications of stem cell transplant
Z48.22 Encounter for aftercare following kidney transplant
Z94.0 Kidney transplant status
Z94.81 Bone marrow transplant status
Z94.84 Stem cells transplant status
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: *B20 is only payable for children under 13 years of age.
*D61.01 is only to be used when patient has failed all first line therapies.
*G61.81 is not payable when associated with diabetes mellitus, dysproteinemias, renal failure, or malnutrition.
Showing 1 to 74 of 74 entries in Group 1
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ICD-10 Codes that DO NOT Support Medical Necessity

Group 1 Paragraph: Any diagnosis codes other than those listed in the covered ICD-10-CM codes of this policy and those in the attached article will be denied as not reasonable and necessary and will be denied provider liable unless a non-coverage notice has been issued to the beneficiary prior to the test. Screening diagnoses will be denied as routine services.

Group 1 Codes: N/A




Additional ICD-10 Information
N/A

Tuesday, January 10, 2017

CPT CODE 88182, 88184, 88187, 88189

Procedure  Codes and Description

Group 1 Paragraph: Note: The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web. For CPT code long descriptors, refer to the current version of CPT.

Group 1 Codes:

88182 Cell marker study
88184 Flowcytometry/ tc 1 marker
88185 Flowcytometry/tc add-on
88187 Flowcytometry/read 2-8
88188 Flowcytometry/read 9-15
88189 Flowcytometry/read 16 & >


Coverage Indications, Limitations, and/or Medical Necessity

Flow cytometry (FCM) is a complex process to examine blood, body fluids, CSF, bone marrow, lymph node, tonsil, spleen and other solid tissues. The use of peripheral blood and fine needle aspirate material avoids more invasive procedures for diagnosis.

A flow cytometer evaluates the physical and/or chemical characteristics of single cells as the cells pass individually in a fluid stream through a measuring device. Surface receptors, intracellular molecules, and DNA bind with fluorescent dyes that allow detection and evaluation.

When light of one wave length excites electrons of certain chemicals to energy levels above their ground state and upon return to ground state emits light of a longer wavelength, fluorescence is produced. A flow cytometer detects cell characteristics by measuring the fluorescence produced by fluorochromes conjugated either directly with cell components or conjugated to antibodies directed against cell components.

Indications
Cytopenias and Hypercellular Hematolymphoid Disorders

Hematolymphoid neoplasia can present with cytopenias (anemia, leucopenia and/or thrombocytopenia) or elevated leukocyte counts. If medical review and preliminary laboratory testing fails to reveal a cause, bone marrow aspiration and biopsy are indicated to rule out an infiltrative process or a stem cell disorder. FCM is essential to evaluate hematolymphoid lineages. Although anemia commonly occurs in nonneoplastic diseases, anemia alone should not automatically trigger FCM.

FCM may be useful in hypercellular hematolymphoid disorders to differentiate reactive conditions from neoplastic conditions. In the absence of blasts, neutrophilic leukocytosis is not generally an indication for FCM. Isolated polycythemia and basophilia are not sufficient to warrant FCM.

Lymphomas 

In the current WHO classification, all non-Hodgkin lymphomas (NHLs) are distinct clinicopathologic entities defined by their clinical features, morpholology, immunophenotype and, where appropriate, their genetic abnormalities. Immunophenotyping by FCM allows multiparameter evaluation of single cells and the ability to work on very small samples.

Most new cases of suspected NHL undergo initial immunophenotypic analysis as part of the routine handling of a specimen. A standard lymphoma panel is designed to identify abnormal populations of B cells, T cells and/or NK cells. A standard lymphoma panel might include a combination of markers from the following categories: T cells (CD2, CD3, CD4, CD5, CD7, CD8); B cells (CD19, CD20, CD23); Kappa and lambda surface immunoglobulins light chains; plasma cells (CD38 and CD138); CALLA (CD10); CD45; CD56: FMC-7, CD103, CD11b, CD13, CD14, CD15, CD16 and CD34.

The immunophenotypes of lymphomas are widely known and FCM allows appropriate classification of most cases. However, atypical patterns occur and pose significant diagnostic difficulties where aberrant antigen expression patterns must be reconciled with morphology. Additional markers may be required to characterize the abnormal population of cells including markers of immature cells (HLA-DR), B cells (CD22) and myeloid cells (CD14, CD15, CD33, CD64, CD117).

Acute Leukemia

The diagnosis and management of acute leukemia depend on the detection, identification and characterization of leukemic cells. The identification of leukemic cells is straightforward in most occasions. However, each acute leukemia subgroup has heterogeneous biologic characteristics, many of which are associated with a different response to therapy.

As part of a routine diagnostic workup, most suspected acute leukemia cases undergo initial multiparameter immunophenotypic analysis, combined with morphology, cytochemistry, cytogenetics, and molecular biology.

A standard acute leukemia FCM panel is designed to determine whether leukemic blasts are of myeloid or lymphoid origin, and then to further classify the neoplastic cells (myeloid blasts, B lymphoblasts, abnormal promyelocytes, monoblasts, etc). An acute leukemia panel might include a combination of cell markers from the following categories: stem cell lineage (CD34), immature cell lineage (HLA-DR, CD 10); T cell (CD2, CD3, CD4, CD5, CD7 and CD8); B cell (CD19, CD20); myeloid cell (CD13, CD14, CD15, CD 33, CD 64 and CD17); CD38, CD45, and CD56.

When the routine panel is insufficient to characterize the leukemic cells, additional antibodies including erythroid markers (CD71 and glycophorin A), megakaryocytic markers (CD41, CD61) or cytoplasmic markers may be indicated.

Chronic Lymphocytic Leukemia (CLL) & Other Chronic Lymphoproliferative Diseases (CLPD)

The history, physical exam (lymphadenopathy, splenomegaly and/or hepatomegaly) laboratory findings (lymphocytosis, granulocytopenia, anemia, thrombocytopenia), and lymphocyte morphology are suggestive of CLL. The diagnosis is established by paradoxical co-expression of CD5 on peripheral lymphocytes that express B cell markers (CD19, CD20, CD21 and CD 23) with Kappa or lambda immunoglobulin light chain restriction. Additional markers such as CD38 and ZAP70 may provide important prognostic information.

FCM can distinguish CLL, the peripheral counterpart of small lymphocytic lymphoma, often diagnosed in lymph node biopsies, from other indolent lymphocytic malignancies including prolymphocytic leukemia, Waldenstrom’s macroglobulinemia, leukemic phase of lymphomas, hairy cell leukemia, T-cell CLL, adult T-cell leukemia, large granulocytic leukemia and cutaneous T-cell lymphoma and natural killer (NK) disorders including KIR expression.


Plasma Cell Disorders

Plasma cell disorders are often identified through a combination of clinical, laboratory studies (urine or serum gamma globulins), morphologic, and radiologic findings. FCM immunophenotyping is useful to identify abnormal plasma cells, and the distinction between lymphoid and plasma cell neoplasms, and between reactive plasma cells and neoplastic plasma cells.

The initial FCM workup for a plasma cell disorder may include the basic lymphoma panel markers with additional markers such as CD28 and CD117.

Myelodysplastic Syndromes (MDS)

The gold standard for an MDS diagnosis is assessment of bone marrow smears for dysplastic changes. FCM may assist in MDS determination through the identification of abnormal maturing myeloid cells. An abnormal phenotype by FCM is a minimal diagnostic MDS criteria to establish a definitive diagnosis.

MDS has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Chronic Myeloproliferative Disorders (CMPD)

Although genetic (Philadelphia chromosome and BCR/abl) and molecular studies (Jak 2) are the accepted cornerstone for the identification and classification of CMPDs, FCM may assist in the distinction from reactive hematopoietic proliferations and is important in the enumeration of blasts in the distinction from acute leukemia and an accelerated phase of CMPD.

CMPD also has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Mast Cell Neoplasms

Mast cell neoplasms are uncommon disorders. Mast cells coexpress multiple markers including CD9, CD33, CD45, CD68, CD117, but also lack several myelomonocytic antigens including CD14, CD15, CD16 and most T- and B- cells antigens. Neoplastic mast cells have a similar antigen profile, but also can coexpress CD2 and CD25, which helps in distinguishing malignant mast cells from mastocytosis.

Paroxysmal hemoglobinuria (PNH)

PNH is a rare clonal hematopoietic disorder of stem cells. This condition is caused by genetic mutation that results in the absence of over a dozen surface antigens on red and white blood cells. FCM can diagnose PNH by assessing both the red and white blood cells for the absence of these antigens.

Minimal Residual Disease (MRD)

FCM analysis for MRD must identify phenotypic features characteristic of the disease of interest. The MRD flow analysis should not rely on an exact match between the phenotype of the residual disease and the original diagnostic specimen because phenotypes can change over time and with treatment. The antibody combinations should be chosen to maximize detection of disease, limit the impact of phenotypic variation, and permit detection of disease following antibody directed therapy.

HIV Infection

HIV-1 infection causes significant changes in the number of CD4 and CD8 positive lymphocytes. CD4 count falls roughly 30% while CD8 count increases within 6 months after seroconversion, causing a decrease in the CD4/CD8 ratio

Following HIV-1 diagnosis, FCM should include enumeration of mature T cells (CD3), helper T cells (CD4) and suppressor T cells (CD8) to ensure all major T cell subsets are accounted for (the sum of helper CD4 and suppressor CD8 T cells is roughly close to the total number of CD3 positive T cells). This ensures that the absolute CD4 is not artificially decreased due to sample degradation or other artifact.

A WBC count with differential also needs to be performed to calculate the absolute CD4 count (absolute lymphocyte count times CD4%).

Organ Transplants

In order to differentiate early rejection, immunosuppressive therapy toxicity or infection, FCM may be indicated to monitor postoperative organ transplants. CD3 is useful to monitor the effectiveness of certain immunosuppressive therapies. When the transplant patient demonstrates symptoms for the above conditions, repeated analysis may be required.

DNA Analysis

Carcinoma, Non-hematolymphoid Tumors
DNA analysis of tumor for ploidy and percent S-phase cells may be necessary for a few selective patients with carcinomas. When the obtained prognostic information will affect treatment decisions in patients with low stage (localized) disease, FCM results are useful.

Molar Pregnancy

FCM is useful to evaluate molar and partial molar pregnancies. Using a method to quantify DNA, similar to that used for evaluation of carcinomas, partial moles (triploid), can be distinguished from normal placenta and complete molar (diploid) pregnancies.

Primary Immunodeficiencies(PIDS)

PIDs are rare disorders that reflect inherited abnormalities in the development and maturation of cells responsible for immune function. More than 120 inherited immunodeficiency disorders are currently recognized. Affected individuals are prone to repeated infections, allergies, autoimmune disorders, and malignancies. Diagnosis typically occurs at an early age.

FCM may be indicated for diagnostic purposes and is usually limited to T (CD3, CD4, CD8), B (CD20) and NK cell (CD56) markers. Additional disease specific markers may be indicated.

Primary Platelet Disorders, Non-neoplastic

FCM is used for platelet analysis in quantitative and qualitative disorders such as Glanzmann Thrombasthenia (GT) and Bernard-Soulier Disease (B-S). GT is a rare inherited or acquired platelet disorder. Hereditary GT is defined by platelets with decreased expression or absence of the GPIIa/GPIIIb receptor. This receptor is responsible for the initial platelet plug at the site of endothelial injury. Absence if the receptor may result in increased bleeding.

Acquired GT is likely an autoimmune phenomenon with the presence of GPIIb/GPIIIa blocking antibodies. FCM may be used to determine the functional effect and identity the molecular targets of these antibodies.

B-S is another rare inherited disorder that prevents the initial binding of platelets at the site of endothelial injury by absence of or presence of abnormal surface GPIa/V/IX receptor. Abnormalities of this receptor prevent attachment of platelets to subendothelial or free von Willebrand’s factor with subsequent tendency to bleed.

FCM may be used to measure antibodies directed at specific loci of the GPIa/V/IX receptor, which include GPIb (CD42b), GPIX (CD42a), and GPV (CD42d). FCM is also used to assess the size of platelets in the initial evaluation of B-S disease. In B-S disease, platelets are generally larger than normal. FCM can distinguish B-S platelets from fragmented RBCs and debris by antibodies directed to the GPIb/IX/V receptor.

Red Cell and White Cell Disorders, Non-neoplastic

FCM is a valuable tool to establish abnormal or defective red blood cell, leukocyte and lymphocyte surface receptors, transmembrane molecules, and intracellular DNA.
It may be used in acquired and congenital red cell conditions such as in quantifying fetomaternal hemorrhage and hereditary spherocytosis, hereditary elliptocytosis, and hereditary persistence of fetal hemoglobin in the context of compound hemoglobinopathy syndromes.

FCM is a sensitive and specific method to identify leukocyte receptor abnormalities for the diagnosis of chronic granulomatous disease and CD11b deficiency.
It is an efficient method to identify lymphocytes HLA B27 associated with uveitis, ankylosing spondylitis, Reiter’s syndrome and sacroiliitis.

Limitations:

Since FCM immunophenotypes for most common lymphomas and leukemias are well characterized, Noridian does NOT consider it “reasonable and necessary” to perform more than 24 markers in a panel. When atypical or unusual FCM results are obtained, the selective addition of more markers may be indicated.

The flow report must document the specific indication for each marker over the 24 marker limit.

The FCM report must document the specific indication for each marker over the 24-marker limit. FCM reports without clear justification for each marker over 24 will be denied.


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
014x Hospital - Laboratory Services Provided to Non-patients
018x Hospital - Swing Beds
021x Skilled Nursing - Inpatient (Including Medicare Part A)
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
071x Clinic - Rural Health
077x Clinic - Federally Qualified Health Center (FQHC)
085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0300 Laboratory - General Classification
0302 Laboratory - Immunology
0309 Laboratory - Other Laboratory



Group 2 Paragraph: Quantitative Codes in immunology section:


Group 2 Codes:

86355 B cells total count
86356 Mononuclear cell antigen
86357 Nk cells total count
86359 T cells total count
86360 T cell absolute count/ratio
86361 T cell absolute count
86367 Stem cells total count



ICD-10 Codes that Support Medical Necessity


ICD-10 CODE DESCRIPTION

A18.01 Tuberculosis of spine
B20 Human immunodeficiency virus [HIV] disease
B97.33 Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere
B97.34 Human T-cell lymphotrophic virus, type II [HTLV-II] as the cause of diseases classified elsewhere
B97.35 Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere
C15.3 Malignant neoplasm of upper third of esophagus
C15.4 Malignant neoplasm of middle third of esophagus
C15.5 Malignant neoplasm of lower third of esophagus
C15.8 Malignant neoplasm of overlapping sites of esophagus
C16.0 Malignant neoplasm of cardia
C16.1 Malignant neoplasm of fundus of stomach
C16.2 Malignant neoplasm of body of stomach
C16.3 Malignant neoplasm of pyloric antrum
C16.4 Malignant neoplasm of pylorus
C16.8 Malignant neoplasm of overlapping sites of stomach
C17.0 Malignant neoplasm of duodenum
C17.1 Malignant neoplasm of jejunum
C17.2 Malignant neoplasm of ileum
C17.8 Malignant neoplasm of overlapping sites of small intestine
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.1 Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C22.0 Liver cell carcinoma
C22.2 Hepatoblastoma
C22.3 Angiosarcoma of liver
C22.4 Other sarcomas of liver
C22.7 Other specified carcinomas of liver
C22.9 Malignant neoplasm of liver, not specified as primary or secondary
C23 Malignant neoplasm of gallbladder
C24.0 Malignant neoplasm of extrahepatic bile duct
C24.1 Malignant neoplasm of ampulla of Vater
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C26.1 Malignant neoplasm of spleen
C26.9 Malignant neoplasm of ill-defined sites within the digestive system
C30.0 Malignant neoplasm of nasal cavity
C30.1 Malignant neoplasm of middle ear
C31.0 Malignant neoplasm of maxillary sinus
C31.1 Malignant neoplasm of ethmoidal sinus
C31.2 Malignant neoplasm of frontal sinus
C31.3 Malignant neoplasm of sphenoid sinus
C31.8 Malignant neoplasm of overlapping sites of accessory sinuses
C32.0 Malignant neoplasm of glottis
C32.1 Malignant neoplasm of supraglottis
C32.2 Malignant neoplasm of subglottis
C32.3 Malignant neoplasm of laryngeal cartilage
C32.8 Malignant neoplasm of overlapping sites of larynx
C33 Malignant neoplasm of trachea
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.2 Malignant neoplasm of middle lobe, bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C37 Malignant neoplasm of thymus
C38.1 Malignant neoplasm of anterior mediastinum
C38.2 Malignant neoplasm of posterior mediastinum
C38.4 Malignant neoplasm of pleura
C38.8 Malignant neoplasm of overlapping sites of heart, mediastinum and pleura
C40.01 Malignant neoplasm of scapula and long bones of right upper limb
C40.02 Malignant neoplasm of scapula and long bones of left upper limb
C40.11 Malignant neoplasm of short bones of right upper limb
C40.12 Malignant neoplasm of short bones of left upper limb
C40.21 Malignant neoplasm of long bones of right lower limb
C40.22 Malignant neoplasm of long bones of left lower limb
C40.31 Malignant neoplasm of short bones of right lower limb
C40.32 Malignant neoplasm of short bones of left lower limb
C40.81 Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb
C40.82 Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb
C41.0 Malignant neoplasm of bones of skull and face
C41.2 Malignant neoplasm of vertebral column
C41.3 Malignant neoplasm of ribs, sternum and clavicle
C41.4 Malignant neoplasm of pelvic bones, sacrum and coccyx
C44.01 Basal cell carcinoma of skin of lip
C44.02 Squamous cell carcinoma of skin of lip
C44.09 Other specified malignant neoplasm of skin of lip
C44.112 Basal cell carcinoma of skin of right eyelid, including canthus
C44.119 Basal cell carcinoma of skin of left eyelid, including canthus
C44.122 Squamous cell carcinoma of skin of right eyelid, including canthus
C44.129 Squamous cell carcinoma of skin of left eyelid, including canthus
C44.192 Other specified malignant neoplasm of skin of right eyelid, including canthus
C44.199 Other specified malignant neoplasm of skin of left eyelid, including canthus
C44.212 Basal cell carcinoma of skin of right ear and external auricular canal

Tuesday, January 3, 2017

Ordering/Referring Physician Documentation Responsibility

Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program. (f) Maintaining and providing access to documentation.

(1) A provider or a supplier who furnishes covered ordered DMEPOS or referred home health, laboratory, imaging, or specialist services is required to maintain documentation for 7 years from the date of service and, upon the request of CMS or a Medicare contractor, to provide access to that documentation. The documentation includes written and electronic documents (including the NPI of the physician who ordered the home health  services and the NPI of the physician or the eligible professional who ordered or referred the DMEPOS, laboratory, imaging, or specialist services) relating to written orders and requests for payments for items of DMEPOS and home health, laboratory, imaging, and specialist services.

(2) A physician who ordered home health services and a physician and an eligible professional who ordered or referred items of DMEPOS or laboratory, imaging, and specialist services is required to maintain documentation for 7 years from the date of the order, certification, or referral and, upon request of CMS or a Medicare contractor, to provide access to that documentation. The documentation includes written and electronic documents (including the NPI of the physician who ordered the home health services and the NPI of the physician or the eligible professional who ordered or referred the DMEPOS, laboratory, imaging, or specialist services) relating to written orders or requests for payments for items of DMEPOS and home health, laboratory, imaging, and specialist services.

The Office of the Inspector General (OIG) U.S. Department of Health and Human Services provides physician educational resources on physician relationships with payers and vendors. These resources are found here: http://oig.hhs.gov/compliance/physician-education/index.asp. The educational information discusses maintaining and providing documentation as well as the importance of legitimate prescriptions for patients.

As a billing provider/supplier, if you are asked and/or required to pay for or refused documentation by a referring/ordering physician, please report the incident as potential fraud and/or abuse. As a referring/ordering physician, if you are asked to sign or write prescriptions for Medicare beneficiaries by a provider/supplier for unnecessary services/items or for patients you do not know, please report the incident.

Executive Summary

When physicians believe their patients may require the expertise of another physician, effective, timely and informative communication between all physicians is essential to ensure appropriate use of specialty care services. The results of physician surveys indicate a lack of informative referral communication exists in Canada. Significant variation exists in referral request processes*. This is contributing to the poor access to specialty care that many patients are experiencing.

Some of this variation is necessary, however, which means that a single, standardized solution to improve the entire referral and consultation process is not feasible. Nonetheless, while communication processes and information requirements for referral requests vary considerably, the communication and information needs in consultant responses is essentially the same for all referring physicians. Unfortunately, provision of this information is often lacking. This problem can be addressed through standard communication protocols because all referring physicians benefit from receiving the same types of information in response to referral requests; for example, acknowledgement of referral receipt or patient consult reports.

Furthermore, when referrals are initiated, specific types of requests can benefit from standardization of communication methods and information requirements. Such activities are already underway in Canada in select areas. These successful initiatives, used together as complementary approaches to address the varying needs of referral requests, should be adopted throughout the country.

RECOMMENDATIONS

** All stakeholders, especially physicians, but also, where appropriate, office assistants, nurses, other health care providers as well as patients, must be engaged in an early and meaningful way regarding any initiative that has a goal to improve referral or consultation processes.

** There is no single best way to access specialist expertise; as a result, a combination of complementary initiatives (e.g., formal consultation systems, standardized referral processes with central intake systems and/or physician directories) should be implemented to reduce variation in the approaches that are used and to facilitate more timely access to specialty care for patients.

** While acknowledging the referring physician’s ability to interpret certain test results, the referral must be accompanied by appropriate information to allow the consulting specialist to fully assess the request, and the referring physician must be informed of what is “appropriate”.

** The referring physician (and family physician if different), as well as the patient, should be kept informed, in a timely fashion, of the status of the referral request, using standardized procedures, minimum information requirements and timelines.

** Physician and/or physician practices should receive compensation and support in recognition of the time and effort undertaken to communicate appropriate information regarding referral requests as well as to conduct electronic or real-time consultations.

The most appropriate method of communication differs depending on the degree of specialist involvement that is required. There are no standards about which method of communication is the most appropriate or effective, or what information is required, for each situation. Referral request processes† vary significantly; not only across specialties but among specialists within a particular specialty and even within a geographic region.

Examples of this variation include: some consulting specialists will accept referrals only if the referring physician has used their specific referral form; others accept referrals using only one particular communication method (e.g., by fax); and others accept referrals on just one day each month. Such variation creates inefficiencies because referring physicians must familiarize themselves with each request process that is required by each consulting specialist.

The range and quality of information provided in a referral request also varies considerably; for example, too little information (i.e. no reason for referral provided), insufficient information (i.e. out-of-date or a lack of lab or imaging tests), or to too much information (i.e. noncontributory family history).

This lack of standardization is problematic. In this context, standardization means simplification rather than obligation. Standardized processes facilitate communications for referrals by removing ambiguities about which method is most appropriate for each situation.

Communication methods and the types of information that are transferred between referring physicians and consulting specialists vary based on numerous factors, ranging from those beyond the control of physicians such as regulations and available technology, to those completely within their control such as their own individual preferences.

An effective way to facilitate appropriate and timely access to specialty care that is within the control of the health care profession is to explore the rationale behind these varying communication and information preferences and address these variations by developing, with meaningful participation and approval from physicians and their administrative staff, standard processes for requesting a specialist referral and for communicating back to the referring physician.

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