Monday, April 24, 2017

Anesthesia CPT code that require authorization


Anesthesiologists are NOT required to request prior authorization. The surgeon must obtain prior authorization when required for procedures identified in the Medical and Surgical Procedure Code List included with the Utah Medicaid
Provider Manual for Physician Services.

The anesthesiologist is required to enter the prior authorization number obtained by the surgeon for the CPT code when billing an ASA code related to a CPT procedure for a hysterectomy, sterilization or abortion. The ASA procedure codes listed below are associated with surgical codes that may require prior authorization by Medicaid.

If federal requirements for obtaining prior authorization for a hysterectomy, sterilization or abortion are not met,Medicaid cannot reimburse either the physician or the anesthesiologist. Exceptions (to the requirement that the surgeon obtain Prior Authorization before the procedure is performed) can
be considered ONLY under one of the following circumstances:

1. The procedure was performed in a life-threatening or justifiable emergency situation.
2. Medicaid is responsible for the delay in prior authorization.
3. The patient is retroactively eligible for Medicaid.

Retroactive authorization for services related to these exceptions may be granted "after-the-fact" with appropriate documentation and review. If approved, the associated ASA code may also be reimbursed.

For additional information about the prior authorization process, refer to the Utah Medicaid Provider Manual, SECTION I, or contact Medicaid Information.

ASA Codes Associated with CPT Codes That May Require Prior Authorization

00402 Anesthesia for reconstructive breast procedures (reduction, augmentation, muscle flaps)

00580 Anesthesia for heart transplant or heart-lung transplant

00796 Liver transplant (recipient)

00840 Anesthesia for intraperitoneal procedures in lower abdomen (hysterectomy and sterilization)

00846 Anesthesia for radical hysterectomy

00848 Anesthesia for pelvic exenteration

00855 Anesthesia for cesarean hysterectomy

00922 Anesthesia for seminal vesicles

00926 Male, external genitalia; radical orchiectomy, inguinal

00928 Anesthesia for inguinal orchiectomy

00932 Anesthesia for complete amputation of penis

00934 Anesthesia for radical amputation of penis with bilateral inguinal lymphadenectomy

00936 Anesthesia for radical amputation of penis with bilateral inguinal and iliac lymphadenectomy

00940 Anesthesia for abortion procedures

00944 Anesthesia for vaginal hysterectomy

00952 Anesthesia for hysteroscopy

Concurrent Medically Directed Anesthesia Procedures

Concurrent Medically Directed Procedures

Concurrency is defined with regard to the maximum number of procedures that the physician is medically directing within the context of a single procedure and whether the other procedures overlap each other. Concurrency is not dependent on each of the cases involving a Medicare patient. For example, if an anesthesiologist directs three concurrent procedures, two of which involve non-Medicare patients and one Medicare patient, this represents three (3) concurrent cases.

The following example illustrates this concept and guides physicians in determining how many procedures are directed:
Procedures A through E are medically directed procedures involving CRNAs. The starting and ending times for each procedure represent the periods during which anesthesia times are counted.

Procedure A begins at 8:00AM and ends at 8:20AM
Procedure B begins at 8:10AM and ends at 8:45AM
Procedure C begins at 8:30AM and ends at 9:15AM
Procedure D begins at 9:00AM and ends at 12:00 noon
Procedure E begins at 9:10AM and ends at 9:55AM

Procedure     Number of Concurrent Medically Directed Procedures     Base Unit Reduction Percentage

A                           2                                                                                              10%
B                           2                                                                                              10%
C                           3                                                                                              25%
D                           3                                                                                              25%
E                           3                                                                                               25%

A physician who is concurrently directing the administration of anesthesia to not more than four (4) surgical patients cannot ordinarily be involved in rendering additional services to other patients. However, addressing an emergency of short duration in the immediate area,administering an epidural or caudal anesthetic to ease labor pain, or periodic, rather than continuous monitoring of an obstetrical patient, does not substantially diminish the scope of control exercised by the physician in directing the administration of anesthesia to the surgical patients.

It does not constitute a separate service for the purpose of determining whether the medical direction criteria are met. Further, while directing concurrent anesthesia procedures, a physician may receive patients entering the operating suite for the next surgery, check or discharge patients in the recovery room, or handle scheduling matters without affecting fee schedule payment.

However, if the physician leaves the immediate area of the operating suite for other than short durations or devotes extensive time to an emergency case or is otherwise not available to respond to the immediate needs of the surgical patients, the physician’s services to the surgical patients are supervisory in nature. No fee schedule payment is made.

The examples listed above are not intended to be an exclusive list of allowed situations. It is expected that the medically-directing anesthesiologist is aware of the nature and type of services he or she is medically directing, and is personally responsible for determining whether his supervisory capacity would be diminished if he or she became involved in the performance of a procedure. It is the responsibility of this medically-directing anesthesiologist to provide services consistent with these regulations.

Saturday, April 22, 2017

Monitored anesthesia cpt code list


CPT/HCPCS Codes

Group 1 Paragraph: These CPT codes are the Anesthesia and Moderate Sedation codes addressed for coverage in this LCD:

Modifiers used:
QS Monitored anesthesia care (MAC)
G8 Monitored anesthesia care (MAC) for deep, complex, complicated, or markedly invasive surgical procedure
G9 Monitored anesthesia care (MAC) for patient who has history of severe cardio-pulmonary condition

Use G8 modifier for the following CPT codes for MAC:
00100
00160
00300
00400
00532
00920


Group 1 Codes:

00100 ANESTHESIA FOR PROCEDURES ON SALIVARY GLANDS, INCLUDING BIOPSY

00124 ANESTHESIA FOR PROCEDURES ON EXTERNAL, MIDDLE, AND INNER EAR INCLUDING BIOPSY; OTOSCOPY

00148 ANESTHESIA FOR PROCEDURES ON EYE; OPHTHALMOSCOPY

00160 ANESTHESIA FOR PROCEDURES ON NOSE AND ACCESSORY SINUSES; NOT OTHERWISE SPECIFIED

00164 ANESTHESIA FOR PROCEDURES ON NOSE AND ACCESSORY SINUSES; BIOPSY, SOFT TISSUE

00300 ANESTHESIA FOR ALL PROCEDURES ON THE INTEGUMENTARY SYSTEM, MUSCLES AND NERVES OF HEAD, NECK, AND POSTERIOR TRUNK, NOT OTHERWISE SPECIFIED

00400 ANESTHESIA FOR PROCEDURES ON THE INTEGUMENTARY SYSTEM ON THE EXTREMITIES, ANTERIOR TRUNK AND PERINEUM; NOT OTHERWISE SPECIFIED

00410 ANESTHESIA FOR PROCEDURES ON THE INTEGUMENTARY SYSTEM ON THE EXTREMITIES, ANTERIOR TRUNK AND PERINEUM; ELECTRICAL CONVERSION OF ARRHYTHMIAS

00520 ANESTHESIA FOR CLOSED CHEST PROCEDURES; (INCLUDING BRONCHOSCOPY) NOT OTHERWISE SPECIFIED

00522 ANESTHESIA FOR CLOSED CHEST PROCEDURES; NEEDLE BIOPSY OF PLEURA

00524 ANESTHESIA FOR CLOSED CHEST PROCEDURES; PNEUMOCENTESIS

00530 ANESTHESIA FOR PERMANENT TRANSVENOUS PACEMAKER INSERTION

00532 ANESTHESIA FOR ACCESS TO CENTRAL VENOUS CIRCULATION

00702 ANESTHESIA FOR PROCEDURES ON UPPER ANTERIOR ABDOMINAL WALL; PERCUTANEOUS LIVER BIOPSY

00740 ANESTHESIA FOR UPPER GASTROINTESTINAL ENDOSCOPIC PROCEDURES, ENDOSCOPE INTRODUCED PROXIMAL TO DUODENUM

00810 ANESTHESIA FOR LOWER INTESTINAL ENDOSCOPIC PROCEDURES, ENDOSCOPE INTRODUCED DISTAL TO DUODENUM

00920 ANESTHESIA FOR PROCEDURES ON MALE GENITALIA (INCLUDING OPEN URETHRAL PROCEDURES); NOT OTHERWISE SPECIFIED

01420 ANESTHESIA FOR ALL CAST APPLICATIONS, REMOVAL, OR REPAIR INVOLVING KNEE JOINT

01730 ANESTHESIA FOR ALL CLOSED PROCEDURES ON HUMERUS AND ELBOW

01780 ANESTHESIA FOR PROCEDURES ON VEINS OF UPPER ARM AND ELBOW; NOT OTHERWISE SPECIFIED

01916 ANESTHESIA FOR DIAGNOSTIC ARTERIOGRAPHY/VENOGRAPHY

01920 ANESTHESIA FOR CARDIAC CATHETERIZATION INCLUDING CORONARY ANGIOGRAPHY AND VENTRICULOGRAPHY (NOT TO INCLUDE SWAN-GANZ CATHETER)

01922 ANESTHESIA FOR NON-INVASIVE IMAGING OR RADIATION THERAPY

01935 ANESTHESIA FOR PERCUTANEOUS IMAGE GUIDED PROCEDURES ON THE SPINE AND SPINAL CORD; DIAGNOSTIC

01936 ANESTHESIA FOR PERCUTANEOUS IMAGE GUIDED PROCEDURES ON THE SPINE AND SPINAL CORD; THERAPEUTIC

01999 UNLISTED ANESTHESIA PROCEDURE(S)

99151 MODERATE SEDATION SERVICES PROVIDED BY THE SAME PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS, REQUIRING THE PRESENCE OF AN INDEPENDENT TRAINED OBSERVER TO ASSIST IN THE MONITORING OF THE PATIENT'S LEVEL OF CONSCIOUSNESS AND PHYSIOLOGICAL STATUS; INITIAL 15 MINUTES OF INTRASERVICE TIME, PATIENT YOUNGER THAN 5 YEARS OF AGE

99152 MODERATE SEDATION SERVICES PROVIDED BY THE SAME PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS, REQUIRING THE PRESENCE OF AN INDEPENDENT TRAINED OBSERVER TO ASSIST IN THE MONITORING OF THE PATIENT'S LEVEL OF CONSCIOUSNESS AND PHYSIOLOGICAL STATUS; INITIAL 15 MINUTES OF INTRASERVICE TIME, PATIENT AGE 5 YEARS OR OLDER

99153 MODERATE SEDATION SERVICES PROVIDED BY THE SAME PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS, REQUIRING THE PRESENCE OF AN INDEPENDENT TRAINED OBSERVER TO ASSIST IN THE MONITORING OF THE PATIENT'S LEVEL OF CONSCIOUSNESS AND PHYSIOLOGICAL STATUS; EACH ADDITIONAL 15 MINUTES INTRASERVICE TIME (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY SERVICE)

99155 MODERATE SEDATION SERVICES PROVIDED BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL OTHER THAN THE PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS; INITIAL 15 MINUTES OF INTRASERVICE TIME, PATIENT YOUNGER THAN 5 YEARS OF AGE

99156 MODERATE SEDATION SERVICES PROVIDED BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL OTHER THAN THE PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS; INITIAL 15 MINUTES OF INTRASERVICE TIME, PATIENT AGE 5 YEARS OR OLDER

99157 MODERATE SEDATION SERVICES PROVIDED BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL OTHER THAN THE PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING THE DIAGNOSTIC OR THERAPEUTIC SERVICE THAT THE SEDATION SUPPORTS; EACH ADDITIONAL 15 MINUTES INTRASERVICE TIME (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY SERVICE)

G0500 MODERATE SEDATION SERVICES PROVIDED BY THE SAME PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL PERFORMING A GASTROINTESTINAL ENDOSCOPIC SERVICE THAT SEDATION SUPPORTS, REQUIRING THE PRESENCE OF AN INDEPENDENT TRAINED OBSERVER TO ASSIST IN THE MONITORING OF THE PATIENT'S LEVEL OF CONSCIOUSNESS AND PHYSIOLOGICAL STATUS; INITIAL 15 MINUTES OF INTRA-SERVICE TIME; PATIENT AGE 5 YEARS OR OLDER (ADDITIONAL TIME MAY BE REPORTED WITH 99153, AS APPROPRIATE)



Coverage Indications, Limitations, and/or Medical Necessity

Monitored Anesthesia Care

With advances in modern medical technology, there has been a shift in supplying some surgical and diagnostic services to an ambulatory, outpatient or office setting. Accompanying this, there has been a change in the provision of anesthesia services from the traditional general anesthetic to a combination of local, regional and certain mind-altering drugs. This type of anesthesia is referred to as monitored anesthesia care (MAC) if directly provided by anesthesia personnel. MAC requires careful and continuous evaluation of various vital physiologic functions and the diagnosis and treatment of any deviations. This type of anesthesia can be provided by a variety of qualified anesthesia personnel.

Coverage for MAC is allowed if the anesthesia service is medically reasonable and necessary and if the procedure for which MAC is given is itself a Medicare benefit and is medically reasonable and necessary.

1. In keeping with the American Society of Anesthesiologists' standards for monitoring, MAC should be provided by qualified anesthesia personnel, (anesthesiologists or qualified anesthetists such as certified registered nurse anesthetists or anesthesia assistants). These individuals must be continuously present to monitor the patient and provide anesthesia care.

2. During MAC, the patient's oxygenation, ventilation, circulation and temperature should be evaluated by whatever method is deemed most suitable by the attending anesthetist. Close monitoring is necessary to anticipate the need for general anesthesia administration or for the treatment of adverse physiologic reactions such as hypotension, excessive pain, difficulty breathing, arrhythmias, adverse drug reactions, etc. In addition, the possibility that the surgical procedure may become more extensive, and/or result in unforeseen complications, requires comprehensive monitoring and/or anesthetic intervention.

3. The following CMS requirements for this type of anesthesia should be the same as for general anesthesia with regards to the performance of pre-anesthetic examination and evaluation, prescription of the anesthesia care required, the completion of an anesthesia record, the administration of necessary oral or parenteral medications and the provision of indicated post-operative anesthesia care. Appropriate documentation must be available to reflect pre and post-anesthetic evaluations and intraoperative monitoring.

4. The MAC service rendered must be appropriate and medically reasonable and necessary.

5. Anesthesia procedures listed in the CPT/HCPCS section are usually provided by the attending surgeon and are included in the global fee and are not separately billable. In certain instances, however, MAC provided by anesthesia personnel may be necessary for these procedures. This is true if there are one or more of the co-existing conditions present that are listed below under the ICD-10-CM code list. In this situation, the appropriate MAC modifier is QS, which should be billed along with the appropriate ICD-10-CM Code for the co-existing condition(s). Second the MAC modifier G8 can be used with the anesthesia services listed below and indicates that the surgical procedure is deep, complex, complicated or markedly invasive. These services include only procedures on the face (00100 and 00160); head, neck, and posterior trunk (00300); breast (00400), or genitalia (00920) and for access to the central venous circulation (00532). These CPT codes themselves do not differentiate complexity. The MAC modifier G9 is used with an anesthesia code to indicate that the patient has a history of a severe cardiopulmonary condition.

In summary, MAC may be necessary and justified for the CPT/HCPCS procedures with the QS modifier if a co-existing condition exists, or if the procedure qualifies for a G8 modifier.

6. Reimbursement for MAC will be the same amount allowed for full general anesthesia services if all the requirements listed under these indications are met. No additional reimbursement is allowed with the use of modifiers (e.g., G8, G9). The provision of quality MAC is mandatory and requires the same expertise and the same effort (work) as required in the delivery of a general anesthetic. If the requirements are not fulfilled or the procedures are unnecessary, payment will be denied in full.

7. The presence of an underlying condition alone, as reported by an ICD-10-CM code, may not be sufficient evidence that MAC is necessary. The medical condition must be significant enough to impact the need to provide MAC, such as the patient being on medication or being symptomatic, etc. The presence of a stable, treated condition of itself is not necessarily sufficient.

The following quote is from Guidelines for the use of deep sedation and anesthesia for GI endoscopy, Gastrointestinal Endoscopy, Volume 56, No. 5, 2002, p. 616. "The routine assistance of an anesthesiologist for average risk patients undergoing standard upper and lower endoscopic procedures is not warranted and is cost prohibitive." This position of the gastrointestinal endoscopy community justifies this LMRP/LCD's position that, to allow payment, MAC for these procedures must be justified by the presence of one of the listed conditions.

Moderate (Conscious) Sedation

Anesthesia services range in complexity. The continuum of anesthesia services, from least intense to most intense in complexity is as follows: local or topical anesthesia, moderate (conscious) sedation, regional anesthesia and general anesthesia. Prior to 2006, Medicare did not recognize separate payment if the same physician provided the medical or surgical procedure and the anesthesia needed for the procedure.

Moderate sedation is a drug induced depression of consciousness during which the patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Moderate sedation does not include minimal sedation, deep sedation or monitored anesthesia care. In 2017, the CPT added new codes 99151-99153, 99155-99157 and G0500 for moderate or conscious sedation.

CPT codes 99151 to 99153 describe moderate sedation provided by the same physician performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patient’s level of consciousness and physiological status. Appendix G has been removed. The value related to moderate sedation has been removed from the codes previously listed in Appendix G. CPT codes 99155 to 99157 describe moderate sedation provided by a physician other than the health care professional performing the diagnostic or therapeutic service that the sedation supports. G0500 describes moderate sedation by the same practitioner when that practitioner is performing an endoscopy service (the pertinent codes are 43200 through 45398, G0105 and G0121).

If the anesthesiologist or CRNA provides anesthesia for diagnostic or therapeutic nerve blocks or injections and a different provider performs the block or injection, then the anesthesiologist or CRNA may report the anesthesia service using CPT code 01991. The service must meet the criteria for monitored anesthesia care. If the anesthesiologist or CRNA provides both the anesthesia service and the block or injection, then the anesthesiologist or CRNA may report the anesthesia service using the conscious sedation code and the injection or block. However, the anesthesia service must meet the requirements for conscious sedation and if a lower level complexity anesthesia service is provided, then the conscious sedation code should not be reported.

If the physician performing the medical or surgical procedure also provides a level of anesthesia lower in intensity than moderate or conscious sedation, such as a local or topical anesthesia, then the conscious sedation code should not be reported and no payment should be allowed by the carrier. There is no CPT code for the performance of local anesthesia and as payment for this service is considered in the payment for the underlying medical or surgical service.

Medicare will cover the codes 99151–99153, 99155-99157 and G0500 under the following conditions:

1. Moderate Sedation should be provided by a qualified physician (as defined by Medicare and within the scope of practice of the state). The physician must be continuously present to monitor the patient and personally provide care.

2. During Moderate Sedation, the patient's oxygenation, ventilation, circulation and temperature should be evaluated by whatever method is deemed most suitable by the attending physician. Close monitoring is necessary to anticipate the need for general anesthesia administration or for the treatment of adverse physiologic reactions such as hypotension, excessive pain, difficulty breathing, arrhythmias, adverse drug reactions, etc. In addition, the possibility that the surgical procedure may become more extensive, and/or result in unforeseen complications, requires comprehensive monitoring and/or anesthetic intervention.

3. The following CMS requirements for Moderate Sedation should be the same as for MAC and general anesthesia with regards to the performance of pre-sedation examination and evaluation, prescription of the sedation care required, the completion of a record, the administration of necessary oral or parenteral medications and the provision of indicated post-operative care. Appropriate documentation must be available to reflect pre and post-sedation evaluations and intraoperative monitoring.

4. The Moderate Sedation service rendered must be appropriate and medically reasonable and necessary.

5. The presence of an underlying condition alone, as reported by an ICD-10-CM code, may not be sufficient evidence that Moderate Sedation is necessary. The medical condition must be significant enough to impact the need to provide Moderate Sedation. The presence of a stable, treated condition of itself is not necessarily sufficient.

6. The above conditions of coverage must be met, however, diagnostic criteria as listed in this LCD will not be applied to Moderate Sedation services.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.




ICD-10 Codes that Support Medical Necessity



ICD-10 CODE DESCRIPTION

A18.84 Tuberculosis of heart
A37.01 Whooping cough due to Bordetella pertussis with pneumonia
A37.11 Whooping cough due to Bordetella parapertussis with pneumonia
A37.81 Whooping cough due to other Bordetella species with pneumonia
A37.91 Whooping cough, unspecified species with pneumonia
A40.3* Sepsis due to Streptococcus pneumoniae
A48.1 Legionnaires' disease
B25.0 Cytomegaloviral pneumonitis
B44.81 Allergic bronchopulmonary aspergillosis
D65 Disseminated intravascular coagulation [defibrination syndrome]
D66 Hereditary factor VIII deficiency
D67 Hereditary factor IX deficiency
D68.0 Von Willebrand's disease
D68.1 Hereditary factor XI deficiency
D68.2 Hereditary deficiency of other clotting factors
D68.311 Acquired hemophilia
D68.312 Antiphospholipid antibody with hemorrhagic disorder
D68.318 Other hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors
D68.32 Hemorrhagic disorder due to extrinsic circulating anticoagulants
D68.4 Acquired coagulation factor deficiency
D68.8 Other specified coagulation defects
D68.9 Coagulation defect, unspecified
E00.0 Congenital iodine-deficiency syndrome, neurological type
E00.1 Congenital iodine-deficiency syndrome, myxedematous type
E00.2 Congenital iodine-deficiency syndrome, mixed type
E00.9 Congenital iodine-deficiency syndrome, unspecified
E01.8 Other iodine-deficiency related thyroid disorders and allied conditions
E02 Subclinical iodine-deficiency hypothyroidism
E03.0 Congenital hypothyroidism with diffuse goiter
E03.1 Congenital hypothyroidism without goiter
E03.2 Hypothyroidism due to medicaments and other exogenous substances
E03.3 Postinfectious hypothyroidism
E03.8 Other specified hypothyroidism
E03.9 Hypothyroidism, unspecified
E05.00 Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm
E05.01 Thyrotoxicosis with diffuse goiter with thyrotoxic crisis or storm
E05.10 Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm
E05.11 Thyrotoxicosis with toxic single thyroid nodule with thyrotoxic crisis or storm
E05.20 Thyrotoxicosis with toxic multinodular goiter without thyrotoxic crisis or storm
E05.21 Thyrotoxicosis with toxic multinodular goiter with thyrotoxic crisis or storm
E05.30 Thyrotoxicosis from ectopic thyroid tissue without thyrotoxic crisis or storm
E05.31 Thyrotoxicosis from ectopic thyroid tissue with thyrotoxic crisis or storm
E05.40 Thyrotoxicosis factitia without thyrotoxic crisis or storm
E05.41 Thyrotoxicosis factitia with thyrotoxic crisis or storm
E05.80 Other thyrotoxicosis without thyrotoxic crisis or storm
E05.81 Other thyrotoxicosis with thyrotoxic crisis or storm
E05.90 Thyrotoxicosis, unspecified without thyrotoxic crisis or storm
E05.91 Thyrotoxicosis, unspecified with thyrotoxic crisis or storm
E08.01 Diabetes mellitus due to underlying condition with hyperosmolarity with coma
E08.11 Diabetes mellitus due to underlying condition with ketoacidosis with coma
E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy
E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
E08.319 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema
E08.36 Diabetes mellitus due to underlying condition with diabetic cataract
E08.39 Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication
E08.65 Diabetes mellitus due to underlying condition with hyperglycemia
E08.69 Diabetes mellitus due to underlying condition with other specified complication
E08.8 Diabetes mellitus due to underlying condition with unspecified complications
E09.01 Drug or chemical induced diabetes mellitus with hyperosmolarity with coma
E09.11 Drug or chemical induced diabetes mellitus with ketoacidosis with coma
E09.21 Drug or chemical induced diabetes mellitus with diabetic nephropathy
E09.311 Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema
E09.319 Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema
E09.36 Drug or chemical induced diabetes mellitus with diabetic cataract
E09.39 Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complication
E09.65 Drug or chemical induced diabetes mellitus with hyperglycemia
E09.69 Drug or chemical induced diabetes mellitus with other specified complication
E09.8 Drug or chemical induced diabetes mellitus with unspecified complications
E10.10 Type 1 diabetes mellitus with ketoacidosis without coma
E10.11 Type 1 diabetes mellitus with ketoacidosis with coma
E10.21 Type 1 diabetes mellitus with diabetic nephropathy
E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E10.36 Type 1 diabetes mellitus with diabetic cataract
E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication
E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified
E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E10.65 Type 1 diabetes mellitus with hyperglycemia
E10.69 Type 1 diabetes mellitus with other specified complication
E10.8 Type 1 diabetes mellitus with unspecified complications
E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)
E11.21 Type 2 diabetes mellitus with diabetic nephropathy
E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.319 Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema
E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E11.65 Type 2 diabetes mellitus with hyperglycemia
E11.69 Type 2 diabetes mellitus with other specified complication
E11.8 Type 2 diabetes mellitus with unspecified complications
E15 Nondiabetic hypoglycemic coma
E16.0 Drug-induced hypoglycemia without coma
E16.1 Other hypoglycemia
E16.3 Increased secretion of glucagon
E16.4 Increased secretion of gastrin
E16.8 Other specified disorders of pancreatic internal secretion
E16.9 Disorder of pancreatic internal secretion, unspecified
E20.0 Idiopathic hypoparathyroidism
E20.8 Other hypoparathyroidism
E20.9 Hypoparathyroidism, unspecified
E21.0 Primary hyperparathyroidism
E21.1 Secondary hyperparathyroidism, not elsewhere classified
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: * A40.1 - A41.9 Acute sepsis supported by diagnosis
* E05.00 - E89.00-Severe metabolic disorders
* E86.0-E87.8 Electrolyte imbalance supported by sodium, potassium or calcium levels, etc, outside normal limits
* E66.01 Two times ideal body weight
* F01.50-F25.8 Brain syndrome/dementia with confusion or combative behavior and various type psychoses (supported by diagnosis)
* F41.0-F41.8 Supported by diagnosis, type and need for and response to sedative medication
* F11.20-F19.288 Acute detoxification state
* F10.10-F10.129 Acute drunkenness
* F12.10-F12.90 Acute detoxification state
* F16.10–F16.90 Acute detoxification state
* F13.10–F13.90 Acute detoxification state
* F11.10–F11.90 Acute detoxification state
* F14.10–F14.90 Acute detoxification state
* F15.10–F15.90 Acute detoxification state
* F19.10–F19.90 Acute detoxification state
* I10 Unstable (systolic pressure over 180, or diastolic over 110 and on more than two anti-hypertensive medications)
* I11.0–I11.9 Acute, multiple medications, etc.
* I60.01-I167.841 Acute condition supported by diagnosis and treatment
* K70.11-K76.89 Hepatic failure (bilirubin greater than 3)
* K92.2) Massive gastrointestinal bleeding (over 500 cc blood loss by history as an example)
* Z93.0 Supported by history, diagnosis
* Z79.891 Use of high-risk medication when that medication may affect the choice of anesthesia

Saturday, April 15, 2017

Immune Globulin Injection cpt codes - j1569


CPT/HCPCS Codes

Group 1 Codes:

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.



ICD-10 Codes that Support Medical Necessity


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

Friday, April 7, 2017

CPT code Flow cytometry


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.


CPT/HCPCS Codes

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 & >

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

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