CPT/HCPCS Codes

70450COMPUTED TOMOGRAPHY, HEAD OR BRAIN; WITHOUT CONTRAST MATERIAL

70460COMPUTED TOMOGRAPHY, HEAD OR BRAIN; WITH CONTRAST MATERIAL(S)

70470COMPUTED TOMOGRAPHY, HEAD OR BRAIN; WITHOUT CONTRAST MATERIAL, FOLLOWED BY CONTRAST MATERIAL(S) AND FURTHER SECTIONS


Coverage Indications, Limitations, and/or Medical Necessity

Computerized axial tomography (CAT) is a non-invasive neurodiagnostic tool that combines X-ray technology with computer capability to create a cross-sectional image. Scanning the head in successive layers by a narrow beam of X-rays enables the transmission of X-ray photons in each layer to be measured. A computer processes the accumulated X-ray photon data to construct a graphic image of a tomographic "slice". Normal intracranial structures and a wide variety of intracranial disorders may be demonstrated.

A diagnostic examination of the head performed by computerized tomography (CT) scanners is covered by Medicare if there is effective use of the scan for a specific condition, if it is reasonable and necessary for the individual patient, and if the scanning device is FDA approved. The use of the CCT scan must be found medically appropriate considering the patient’s symptoms and preliminary diagnosis.

A. A CCT scan is considered reasonable and necessary for the patient when the diagnostic exam is medically appropriate given the patient's symptoms and preliminary (or provisional) diagnosis.

B. CCT scans (as opposed to MRI evaluations) are used effectively in the following situations or conditions:

1. Patients who are not suitable candidates for MRI evaluation:

a) because of a pacemaker or intracranial metallic objects
b) because of extreme obesity
c) because of an inability to lie still


2. Patients whose condition requires the visualization of fine bone detail or calcification

3. Patients with the following conditions:

a) Acute CNS Hemorrhage
b) Strokes or encephalomalacia
c) New onset seizures, particularly if a focal component is present (contrast agent is appropriate for these patients)
d) Meningiomas or CNS lesions large enough to cause increased intracranial pressure (CCT scan is useful to determine gross margins between tumor and edematous brain)


C. There is no general rule that requires other diagnostic tests to be tried before CCT scanning is used. However, in individual cases it may be determined that use of a CCT scan as the initial diagnostic test was not reasonable and necessary because it was not supported by the patient’s symptoms or complaints as stated on the claim.

D. CCT imaging has not been useful in general for the evaluation of headache or dizziness and should be reserved for the patient whose presentation indicates a focal problem or who has experienced a significant change in symptomatology.

E. A CCT scan for the diagnosis of headache (ICD-10 code G44.1) can be allowed for the following:

1. After a head injury to rule out intracranial bleeding
2. Headache unusual in duration (greater than two weeks) not responding to medical therapy, to rule out the possibility of a tumor
3. A headache characterized by sudden onset and severity to rule out the possibility of an aneurysm, bleeding and/or arteriovenous malformation


F. A CCT Scan may be ordered without contrast, with contrast, or without contrast followed by contrast. Contrast administration is not without risk to the patient, and for some conditions, adds little or no benefit to the patient. The general indications for use of contrast CCT scanning (as opposed to non-contrast scanning) are to:

1. Assess perfusion (e.g. CVA)
2. Characterize a specific lesion
3. Detect defects in blood/brain barrier (e.g. infarct, tumor, infection, vasculitis)
4. Detect neovascularity (tumor), and
5. For staging of known lung cancer, breast cancer, and lymphomas likely to metastasize early to the brain


G. Intravenous contrast generally adds no information to CCT scans done secondary to head trauma (ICD-10 CM codes S02.XXA, S02.0XXB, S02.110A, S02.111A, S02.112A, S02.118A, S02.110B, S02.111B, S02.112B, S02.118B, S02.19XB, S02.2XXA, S02.2XXB, S02.69XA, S02.61XA, S02.62XA, S02.63XA, S02.64XA, S02.65XA, S02.66XA, S02.67XA, S02.69XA, S02.69XB, S02.61XB, S02.62XB, S02.63XB, S02.64XB, S02.65XB, S02.66XB, S02.67XB, S02.69XB, S02.411A, S02.412A, S02.413A, S02.411B, S02.412B, S02.413B, S2.411B, S02.412B, S02.413B, S02.3XXA, S02.3XXB, S02.42XA, S02.8XXA, S02.42XB, S02.8XXB, S06.6X0A, S06.6X1A, S06.6X2A, S06.6X3A, S06.6X4A, S06.6X5A, S06.6X6A, S06.6X7A, S06.6X8A, S06.6X0A, S06.5X0A, S06.5X1A, S06.5X2A, S06.5X3A, S06.5X4A, S06.5X5A, S06.5X6A, S06.5X7A, S06.5X8A, S06.5X0A, S06.4X0A, S06.4X1A, S06.4X2A, S06.4X3A, S06.4X4A, S06.4X5A, S06.4X6A, S06.4X7A, S06.4X8A, S06.340A, S06.350A, S06.341A, S06.342A, S06.351A, S06.352A, S06.343A, S06.344A, S06.353A, S06.354A, S06.345A, S06.355A, S06.346A, S06.347A, S06.348A, S06.356A, S06.357A, S06.358A, S06.890A, S06.1X0A, S06.2X0A, S06.810A, S06.820A, S06.890A, S06.1X1A, S06.1X2A, S06.2X1A, S06.2X2A, S06.811A, S06.812A, S06.821A, S06.822A, S06.891A, S06.892A, S06.1X3A, S06.1X4A, S06.2X3A, S06.2X4A, S06.813A, S06.814A, S06.823A, S06.824A, S06.893A, S06.894A, S06.1X5A, S06.2X5A, S06.815A, S06.825A, S06.895A, S06.1X6A, S06.1X7A, S06.1X8A, S06.2X6A, S06.2X7A, S06.2X8A, S06.816A, S06.817A, S06.818A, S06.826A, S06.827A, S06.828A, S06.896A, S06.897A, S06.898A). Additional symptoms suggesting a possible intracranial bleed may justify the use of contrast. These symptoms should be documented in the medical record, and if appropriate, included in the diagnostic codes listed on the claim.

H. More than one contrast CCT scan per episode of illness adds no information with the following exceptions:

1. CVA
2. Non-traumatic hemorrhage
3. TIA
4. Post-operative scan for residual tumor
5. Known brain tumor/metastases with a change in mental status



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.
012xHospital Inpatient (Medicare Part B only)
013xHospital Outpatient
085xCritical 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.

0250Pharmacy - General Classification
0254Pharmacy - Drugs Incident to Other Diagnostic Services
0255Pharmacy - Drugs Incident to Radiology
0258Pharmacy - IV Solutions
0351CT Scan - Head Scan


ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

A06.6Amebic brain abscess
A17.0Tuberculous meningitis
A17.1Meningeal tuberculoma
A17.81Tuberculoma of brain and spinal cord
A17.82Tuberculous meningoencephalitis
A17.83Tuberculous neuritis
A17.89Other tuberculosis of nervous system
A18.03Tuberculosis of other bones
A18.51Tuberculous episcleritis
A18.52Tuberculous keratitis
A18.53Tuberculous chorioretinitis
A18.54Tuberculous iridocyclitis
A18.59Other tuberculosis of eye
A18.6Tuberculosis of (inner) (middle) ear
A39.0Meningococcal meningitis
A39.1Waterhouse-Friderichsen syndrome
A39.2Acute meningococcemia
A39.3Chronic meningococcemia
A39.51Meningococcal endocarditis
A39.52Meningococcal myocarditis
A39.53Meningococcal pericarditis
A39.81Meningococcal encephalitis
A39.82Meningococcal retrobulbar neuritis
A39.83Meningococcal arthritis
A39.84Postmeningococcal arthritis
A39.89Other meningococcal infections
A50.32Late congenital syphilitic chorioretinitis
A50.39Other late congenital syphilitic oculopathy
A50.41Late congenital syphilitic meningitis
A50.42Late congenital syphilitic encephalitis
A50.43Late congenital syphilitic polyneuropathy
A50.44Late congenital syphilitic optic nerve atrophy
A50.45Juvenile general paresis
A50.49Other late congenital neurosyphilis
A50.51Clutton's joints
A50.52Hutchinson's teeth
A50.53Hutchinson's triad
A50.54Late congenital cardiovascular syphilis
A50.55Late congenital syphilitic arthropathy
A50.56Late congenital syphilitic osteochondropathy
A50.57Syphilitic saddle nose
A50.59Other late congenital syphilis, symptomatic
A50.6Late congenital syphilis, latent
A52.11Tabes dorsalis
A52.12Other cerebrospinal syphilis
A52.13Late syphilitic meningitis
A52.14Late syphilitic encephalitis
A52.15Late syphilitic neuropathy
A52.16Charcot's arthropathy (tabetic)
A52.17General paresis
A52.19Other symptomatic neurosyphilis
A52.2Asymptomatic neurosyphilis
A81.01Variant Creutzfeldt-Jakob disease
A81.09Other Creutzfeldt-Jakob disease
A81.1Subacute sclerosing panencephalitis
A81.2Progressive multifocal leukoencephalopathy
A81.81Kuru
A81.82Gerstmann-Straussler-Scheinker syndrome
A81.83Fatal familial insomnia
A81.89Other atypical virus infections of central nervous system
A83.0Japanese encephalitis
A83.1Western equine encephalitis
A83.2Eastern equine encephalitis
A83.3St Louis encephalitis
A83.4Australian encephalitis
A83.5California encephalitis
A83.6Rocio virus disease
A83.8Other mosquito-borne viral encephalitis
A84.0Far Eastern tick-borne encephalitis [Russian spring-summer encephalitis]
A84.1Central European tick-borne encephalitis
A84.8Other tick-borne viral encephalitis
A85.0Enteroviral encephalitis
A85.1Adenoviral encephalitis
A85.8Other specified viral encephalitis
A87.0Enteroviral meningitis
A87.1Adenoviral meningitis
A87.2Lymphocytic choriomeningitis
A87.8Other viral meningitis
A88.8Other specified viral infections of central nervous system
A92.31West Nile virus infection with encephalitis
B00.4Herpesviral encephalitis
B01.0Varicella meningitis
B01.11Varicella encephalitis and encephalomyelitis
B01.12Varicella myelitis
B01.2Varicella pneumonia
B01.81Varicella keratitis
B01.89Other varicella complications
B01.9Varicella without complication
B02.0Zoster encephalitis
B02.1Zoster meningitis
B02.21Postherpetic geniculate ganglionitis
B02.22Postherpetic trigeminal neuralgia
B02.23Postherpetic polyneuropathy
B02.24Postherpetic myelitis
B02.29Other postherpetic nervous system involvement
B02.31Zoster conjunctivitis
B02.32Zoster iridocyclitis
B02.33Zoster keratitis
B02.34Zoster scleritis
B02.39Other herpes zoster eye disease

CPT CODE                DESCRIPTION

78000 THYROID RAI UPTAKE

78001 THYROID, MULTIPLE UPTAKES

78003 THYROID SUPPRESS OR STIMULATION

78006 THYROID UPTAKE AND SCAN

78007 THYROID, IMAGE, MULTIPLE UPTAKES

78010 THYROID SCAN ONLY

78011 THYROID IMAGING WITH FLOW

78015 THYROID MET IMAGING

78016 THYROID MET IMAGING WITH ADDITIONAL STUDIES

78018 THYROID SCAN WHOLE BODY

78020 THYROID CARCINOMA METASTASES UPTAKE

78070 PARATHYROID NUCLEAR IMAGING

78075 ADRENAL NUCLEAR IMAGING

78099 UNLISTED ENDOCRINE PROCEDURE, DIAGNOSTIC NUCLEAR MEDICINE

78102 BONE MARROW IMAGING, LIMITED

78103 BONE MARROW IMAGING, MULTIPLE

78104 BONE MARROW IMAGING, WHOLE BODY

78110 PLASMA VOLUME, SINGLE

78111 PLASMA VOLUME, MULTIPLE SAMPLING

78120 RED CELL VOLUME DETERMINATION, SINGLE SAMPLING

78121 RED CELL VOLUME DETERMINATION, MULTIPLE SAMPLING

78122 WHOLE BLOOD VOLUME DETERMINATION, SEP PLASMA & RED CELL

78130 RED CELL SURVIVAL STUDY

78135 DIFFERENTIAL ORGAN / TISSUES KINETIC

78140 LABELED RED CELL SEQUESTRATION

78160 PLASMA RADIOIRON DISAPEARANCE

78162 RADIOIRON ORAL ABSORPTION

78170 RED CELL IRON UTILIZATION

78172 TOTAL BODY IRON ESTIMATION

78185 SPLEEN IMAGING W & W/O VAS FLOW

78190 PLATELET SURVIVAL, KINETICS

78191 PLATELET SURVIVAL

78195 LYMPH SYSTEM IMAGING

78199 UNLISTED HEMATOPOIETIC DIAGNOSTIC NUCLEAR MED

78201 LIVER IMAGING

78202 LIVER IMAGING WITH FLOW

78205 LIVER IMAGING SPECT (3-D)

78206 LIVER IMAGING SPECT W/ VASCULAR FLOW

78215 LIVER & SPLEEN IMAGING

78216 LIVER & SPLEEN IMAGING WITH FLOW

78220 LIVER FUNCTION STUDY

78223 HIDA SCAN

78230 SALIVARY GLAND IMAGING

78231 SERIAL SALIVARY GLAND

78232 SALIVARY GLAND FUNCTION EXAM

78258 ESOPHOGUS MOTILITY STUDY

78261 GASTRIC MUCOSA IMAGING

78262 GASTROESOPHAGEAL REFLUX EXAM

78264 GASTRIC EMPTYING STUDY

78270 VIT-B12 ABSORPTION EXAM

78271 VIT-B12 ABSORPTION EXAM, LF

78272 VIT-B12 ABSORPTION EXAM COMBINED

78278 GI BLEEDER SCAN

78282 GI PROTEIN LOSS EXAM

78290 MECKEL’S DIVERTICULUM IMAGING

78291 LEVEEN SHUNT PATENCY EXAM

79299 UNLISTED GASTROINTESTINAL

78300 BONE OR JOINT IMAGING LTD

78305 BONE OR JOINT IMAGING MULTIPLE

78306 BONE SCAN WHOLE BODY

78315 BONE SCAN 3-PHASE STUDY

78320 BONE JOINT IMAGING TOMO TEST

78350 BONE MINERAL, SINGLE PHOTON

78351 BONE MINERAL, DUAL PHOTON

78399 UNLISTED MUSCULOSKELETAL

78414 NON-IMAGING HEART FUNCTION

78428 CARDIAC SHUNT IMAGING

78445 RADIONUCLIDE VENOGRAM NON-CARDIAC

78455 VENOUS THROMBOSIS STUDY

78457 VENOUS THROMBOSIS IMAGING UNILATERAL

78458 VENOUS THROMBOSIS IMAGES, BILATERAL

78460 THALLIUM SCAN REST ONLY

78461 MYOCARDIAL PERF STRESS OR REST MULTIPLE STUDY

78464 HEART IMAGE (3-D) SINGLE

78465 MYOCARDIAL PERF W/SPECT MULTIPLE

78466 MYOCARDIAL INFARCTION SCAN

78468 HEART INFARCT IMAGE EF

78469 HEART INFARCT IMAGE 3-D


78472 GATED HEART, RESTING

78473 CARDIAC BLOOD POOL M

 REPORTING MEDICARE ON THE MEDICAID NURSING FACILITY CLAIM When reporting Medicare, nursing facilities must bill as outlined below.

* Covered Days

* Covered days must be reported using Value Code 80.

* Covered days are the days in which Medicare approves payment for the beneficiary’s skilled care. Covered days must be reported when the primary insurance makes a payment.

* Non-Covered Days

* Non-covered days must be reported using Value Code 81.

* Non-covered days are the days not covered by Medicare due to Medicare being exhausted or the beneficiary no longer requiring skilled care. Non-covered days must be reported in order to receive the proper Medicaid provider rate payment.

* When Medicare non-covered days are reported because Medicare benefits are exhausted, facilities must report Occurrence Code A3 and the date benefits were exhausted, along with Claim Adjustment Reason Code (CARC) 96 (Non-Covered Charges) or 119 (Benefit Maximum for the Time Period has been Reached).


* When Medicare non-covered days are reported because Medicare active care ended, facilities must report Occurrence Code 22 and the corresponding date Medicare active care ended, along with CARC 96 or 119.

* Coinsurance Days

* Medicare coinsurance days must be reported using Value Code 82.

* Coinsurance days are the days in which the primary payer (Medicare or Medicare Advantage Plan) applies a portion of the approved amount to coinsurance.

Coinsurance days must be reported in order to receive the proper coinsurance rate payment.

* When reporting Value Code 82, Occurrence Span Code 70 (Qualifying Stay Dates for SNF) and corresponding from/through dates (at least a three-day inpatient hospital stay which qualifies the resident for Medicare payment of SNF services) must also be
reported.

* Facilities billing for beneficiaries in a Medicare Advantage Plan must report CARC 2, and this must equal the Medicare Advantage Plan coinsurance rate times the number of coinsurance days. Facilities using CARC 2 must report it with the amount equal to the coinsurance rate times the number of coinsurance days reported.

* Medicare Advantage Plan coinsurance rates vary and do not always equal the Medicare Part A coinsurance rate. Providers must verify the beneficiary’s Medicare Advantage Plan coinsurance rate prior to billing Medicaid.

* Prior Stay Date

* If a SNF or nursing facility stay ended within 60 days of the SNF admission, Occurrence Span Code 78 and the from/through dates must be reported along with Occurrence Span Code 70 and the from/through dates.

* Nursing Facilities with Medicaid-Only Certified Beds Not Billing Medicare

* For nursing facilities with Medicaid-only certified beds not billing Medicare, claims submitted directly to Medicaid must be billed as outlined above. For example, for eneficiaries with Medicare coverage based on Medicaid’s TPL file, covered days
must be left blank if Medicare is not covering the service or benefits have exhausted as Medicare is the primary payer. The non-covered day must be completed and it must equal the service units billed for room and board revenue codes and/or leave
days revenue codes.

The reason Medicare is not covering the service (e.g., benefits exhausted) must also be reported.

* Claim Examples

* Nursing facility claim examples on how to report Medicare and commercial insurance on the Medicaid nursing facility secondary claim can be found on the MDHHS website

CRISIS SERVICES

Crisis Interventions Crisis Interventions are unscheduled activities conducted for the purpose of resolving a crisis situation requiring immediate attention. Activities include crisis response, crisis line, assessment, referral, and direct therapy.

The standard for whether or not a crisis exists is a "prudent layperson" standard. That means that a prudent layperson would be able to determine from the beneficiary’s symptoms that crisis services are necessary. Crisis means a situation in which an individual is experiencing the signs and symtoms of a serious behavioral health disorder, and one of the following applies:

* The individual can reasonably be expected within the near future to physically injure himself or another individual, either intentionally or unintentionally;

* The individual is unable to provide himself food, clothing, or shelter, or to attend to basic physical activities such as eating, toileting, bathing, grooming, dressing, or ambulating, and this inability may lead in the near future to harm to the individual or to another individual; or

* The individual’s judgment is so impaired that he is unable to understand the need for treatment and, in the opinion of the behavioral health professional, his continued behavior as a result of the behavioral health disorder can reasonably be expected in the near future to result in physical harm to the individual or to another individual.

If the beneficiary developed a crisis plan, the plan is followed with permission from the beneficiary.

Crisis Residential Services

Crisis residential services are intended to provide a short-term alternative to inpatient psychiatric services for beneficiaries experiencing an acute psychiatric crisis when clinically indicated. Services may be used to avert an inpatient psychiatric admission or to shorten the length of an inpatient stay. Additionally, these services are designed for a subset of beneficiaries who meet the ASAM Criteria for Level 3.7 Medically Monitored Intensive Inpatient Services admission criteria or are at risk of admission, but who can be appropriately served in settings less intensive than a hospital. This service is also designed for beneficiaries who are intoxicated and at risk of admission to an acute setting or another level of care but can be appropriately served in this less intensive setting. The goal of crisis residential services is to facilitate reduction in the intensity of those factors that lead to crisis residential admission through a personcentered/ individualized and recovery-oriented approach.



* Population: Services are designed for a subset of beneficiaries who meet psychiatric inpatient/substance use disorder residential admission criteria or are at risk of admission to a high level of care setting but who can be appropriately served in a less intensive setting.

* Covered Services: Services must be designed to resolve the immediate crisis and improve the functioning level of the beneficiary to allow them to return to less intensive community living as soon as possible. Covered crisis residential services include:

* Psychiatric supervision (for programs providing mental health services and/or co-occurring disorders);

* Therapeutic support services;

* Medication management/stabilization and education;

* Behavioral services;

* Milieu therapy; and

* Nursing/medical services (on-site nursing services are required for those beneficiaries who are in the detoxification process, and who require medications to manage the current crisis).

Beneficiaries who are admitted to crisis residential services must be offered the opportunity to explore and learn more about crises, mental health disorders, substance use disorders, identity, values, choices and choice-making, recovery and recovery planning. Recovery and recovery planning is inclusive of all aspects of life, including relationships, where to live, training, employment, daily activities, and physical well-being.

The program must include on-site nursing services (Registered Nurse [RN] or Licensed Practical Nurse [LPN] under appropriate supervision).

* For settings of 6 beds or fewer: on-site nursing must be provided at least one hour per day, per resident, seven days per week, with 24-hour availability on-call.

* For 7-16 beds: on-site nursing must be provided eight hours per day, seven days per week, with 24-hour availability on-call.

* Provider Criteria: The PIHP must seek and maintain MDHHS approval for the crisis residential program in order to use Healthy Michigan Plan funds for program services. Healthy Michigan Plan crisis residential programs may choose to provide a program for serious mental illness, intellectual/developmental disabilities, substance use disorders or a combined program. A program offering services for substance use disorders must be licensed for residential substance use disorder treatment services per the Administrative Rules for Substance Use Disorder Programs and appropriately accredited through one of the organizations identified in the Substance Abuse Services subsection of the Mental Health/Substance Abuse Chapter. Established residential programs that purport to offer this service for individuals with substance use disorders will be required to seek re-approval of the program by MDHHS when appropriate licensing and accreditation has been obtained. Programs currently approved to provide services for mental health and/or intellectual/developmental disabilities by MDHHS through the delivery of Medicaid State Plan, Habilitation Supports Waiver (HSW), or additional/B3 services do not require re-approval.

* Qualified Staff: Treatment services must be clinically supervised by a psychiatrist. A psychiatrist need not be present when services are delivered but must be available by telephone at all times. The psychiatrist must provide psychiatric evaluation or assessments at the crisis residential home. Medication reviews performed at the crisis residential home must be performed by a physician, physician assistant or a nurse practitioner under the clinical supervision of the psychiatrist. The covered crisis residential services must be supervised onsite eight hours a day, Monday through Friday (and on call at all other times). Supervision must be by a behavioral health professional (Mental Health Professional [MHP] and/or a Substance Abuse Treatment Specialist [SATS] depending on the scope of services being provided) possessing at least a master’s
degree in human services and one year of experience providing behavioral health services to individuals with serious mental illness and/or substance use disorders; or a bachelor’s degree in human services and at least two years of experience providing behavioral health services to individuals with serious mental illness and/or substance use disorders.


Treatment activities may be carried out by paraprofessional staff who have at least one year of satisfactory work experience providing behavioral health services to individuals with mental illness and/or substance use disorders, or who have successfully completed a PIHP/ MDHHS-approved training program for working with individuals with mental illness and/or substance use disorders.

Peer support specialists and/or recovery coaches may be part of the multidisciplinary team and can facilitate some of the activities based on their scope of practice, such as facilitating peer lead support groups, assisting in transitioning beneficiaries to less intensive services, and by mentoring beneficiaries towards recovery.

* Location of Services: Services must be provided to beneficiaries in licensed crisis residential foster care, group home settings not exceeding 16 beds in size, or in a licensed substance use disorder residential treatment program (when providing services for substance use disorders). Homes/settings must have appropriate licensure from the State and must be approved by MDHHS to provide specialized crisis residential services. Services must not be provided in a hospital
or other institutional setting.

 Admission Criteria: Crisis residential services may be provided to beneficiaries who are assessed by, and admitted through, the authority of the local PIHP.

Beneficiaries must meet psychiatric inpatient admission or residential substance use disorder level of care criteria but have symptoms and risk levels that permit them to be treated in such alternative settings. Services are designed for beneficiaries with mental health or substance use disorders, beneficiaries with a co-occurring mental health and substance use disorder, or beneficiaries with intellectual/developmental disabilities. For beneficiaries with a concomitant disorder with an intellectual/developmental disability, the primary reason for service must be mental illness or substance use disorder.

* Duration of Services: Services may be provided for a period up to 14 calendar days per crisis residential episode. Services may be extended and regularly monitored, if justified by clinical need, as determined by the interdisciplinary team. For substance use disorders, beneficiaries should be moved to another ASAM Level of Care within 14 days; however, services may be extended if justified by clinical need, medical necessity, and as determined by the interdisciplinary team.

* Individual Plan of Service/Treatment Plan: Services must be delivered according to an Individual Plan of Service (IPOS) or appropriate treatment plan process for substance use disorder beneficiaries (refer to the Treatment Planning subsection of the Mental Health/Substance Abuse Chapter) based on an assessment of immediate need. The IPOS/treatment plan must be developed within 48 hours of admission and signed by the beneficiary (if possible), the guardian, the psychiatrist, and any other professionals involved in the treatment planning process as determined by the needs of the beneficiary. If the beneficiary has an assigned case manager, the case manager must be involved in the treatment as soon as possible, and must also be involved in follow-up services.


The IPOS/treatment plan must contain:

* Clearly stated goals and measurable objectives, derived from the assessment of immediate need, stated in terms of specific observable changes in behavior, skills, attitudes, or circumstances, structured to resolve the crisis;


* Identification of the activities designed to assist the beneficiary to attain his goals and objectives; and

* Discharge plans, the need for aftercare/follow-up services, and the role of, and identification of, the case manager.

If the length of stay in the crisis residential program exceeds 14 days, an interdisciplinary team must develop a subsequent plan based on comprehensive assessments. The team is comprised of the beneficiary, the guardian, the psychiatrist,the case manager and other professionals whose disciplines are relevant to the needs  of the beneficiary, including the individual Assertive Community Treatment (ACT) team, outpatient services provider, when applicable. If the beneficiary did not have a case manager prior to initiation of the intensive/crisis residential service and the crisis episode exceeds 14 days, a case manager must be assigned and involved in treatment and follow-up care. (The case manager may be assigned prior to the 14 days
according to need.)



Intensive/Crisis Stabilization Services

Intensive/crisis stabilization services are structured treatment and support activities provided by a multidisciplinary team and designed to provide a short-term alternative to inpatient psychiatric services and/or substance use disorder residential treatment in a community setting. Services may be used to avert a psychiatric admission, residential substance use disorder admission, or to shorten the length of an inpatient or substance use disorder residential stay when clinically indicated.
Crisis situation means a situation in which an individual is experiencing the signs and symptoms of a serious behavioral health disorder, and one of the following applies:


* The individual can reasonably be expected within the near future to physically injure himself or another individual, either intentionally or unintentionally;

* The individual is unable to provide himself food, clothing, or shelter, or to attend to basic physical activities such as eating, toileting, bathing, grooming, dressing, or ambulating, and this inability may lead in the near future to harm to the individual or to another individual; or

* The individual’s judgment is so impaired that he is unable to understand the need for treatment and, in the opinion of the behavioral health professional, his continued behavior as a result of the behavioral health disorder can reasonably
be expected in the near future to result in physical harm to the individual or to another individual.


* Approval: The PIHP must seek and maintain MDHHS approval for the intensive/crisis stabilization services in order to use Healthy Michigan Plan funds for program services. A program that will be offering services for substance use disorders must be licensed for outpatient substance use disorder treatment services per the Administrative Rules for Substance Use Disorder Programs and appropriately accredited through one of the organizations identified in the Substance Abuse Services subsection of the Mental Health/Substance Abuse Chapter. Established crisis stabilization service programs that purport to offer this service for individuals with substance use disorders will be required to seek reapproval of the program by MDHHS when appropriate licensing and accreditation has been obtained. Programs currently approved to provide services for mental health and/or intellectual/developmental disabilities by MDHHS through the delivery of Medicaid State Plan, Habilitation Supports Waiver (HSW), or additional/B3 services do not require re-approval.


* Population: These services are for beneficiaries who have been assessed to meet criteria for psychiatric hospital admissions and/or substance use disorder residential/inpatient treatment but who, with intense interventions, can be stabilized and served in their usual community environments. These services may also be provided to beneficiaries leaving inpatient psychiatric services and/or substance use disorder residential/inpatient treatment if such services will result
in a shortened stay. Beneficiaries must have a diagnosis of mental illness, substance use disorder or mental illness with a co-occurring substance use disorder, or intellectual/developmental disability.

* Services: Intensive/crisis stabilization services are intensive treatment interventions delivered by an intensive/crisis stabilization treatment team under the supervision of a psychiatrist. Component services include:

* Intensive individual counseling/psychotherapy;

* Assessments (rendered by the treatment team);

* Family therapy;

* Psychiatric supervision; and

* Therapeutic support services by trained paraprofessionals.

* Qualified Staff: Intensive/crisis stabilization services must be provided by a treatment team of behavioral health professionals under the supervision of a psychiatrist. The psychiatrist need not provide on-site supervision at all times, but must be available by telephone at all times. The treatment team providing intensive/crisis stabilization services must be Mental Health Professionals and/or Substance Abuse Treatment Specialists. Nursing services/consultation must be available.

The treatment team may be assisted by trained paraprofessionals under appropriate supervision. Trained paraprofessionals must have at least one year of satisfactory work experience providing services to individuals with behavioral health disorders. Activities of trained paraprofessionals include assistance with therapeutic support services. In addition, the team may include one or more peer support specialists and/or recovery coaches.

* Location of Services: Intensive/crisis stabilization services may be provided where necessary to alleviate the crisis situation, and to permit the beneficiary to remain in, or return more quickly to, his usual community environment.

Intensive/crisis stabilization services must not be provided exclusively or predominantly at residential programs.

Exceptions: Intensive/crisis stabilization services may not be provided in:

* Inpatient settings;

* Jails or other settings where the beneficiary has been adjudicated; or

* Crisis residential settings.

* Individual Plan of Service/Treatment Plan: Intensive/crisis stabilization services may be provided initially to alleviate an immediate behavioral health crisis. However, following resolution of the immediate situation (and within no more than 48 hours), an intensive/crisis stabilization services IPOS or appropriate treatment plan process for substance use disorder beneficiaries (refer to the Treatment Planning subsection of the Mental Health/Substance Abuse Chapter) must be developed. The intensive/crisis stabilization IPOS/treatment plan must be developed through a person-centered planning process in consultation with the psychiatrist. Other professionals may also be involved if required by the needs of the beneficiary. The case manager (if the beneficiary receives case management services) must be involved in the treatment and follow-up services.

The IPOS/treatment plan must contain:

* Clearly stated goals and measurable objectives, derived from the assessment of immediate need, and stated in terms of specific observable changes in behavior, skills, attitudes, or circumstances structured to resolve the crisis.

* Identification of the services and activities designed to resolve the crisis and attain the beneficiary's goals and objectives.

* Plans for follow-up services (including other behavioral health services where indicated) after the crisis has been resolved. The role of the case manager must be identified, where applicable.

EXPERIMENTAL OR INVESTIGATIONAL PROCEDURES


Any drug, device or medical treatment or procedure and related services that are experimental or investigational as defined by BCBSKS are non-covered services.

Experimental or investigational refers to the status of a drug, device or medical treatment or procedure:

A. if the drug or device cannot be lawfully marketed without approval of the U.S. Food and Drug Administration and approval for marketing has not been given at the time the drug or device is furnished and the drug or device is not Research-Urgent as defined except for prescription drugs used to treat cancer when the prescription drug is recognized for treatment of the indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature; or
B. if Credible Evidence shows that the drug, device or medical treatment or procedure is the subject of ongoing phase I, II, or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis and the trials are not Research-Urgent as defined except for prescription drugs used to treat cancer when the prescription drug is recognized for treatment of the indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature; or

C. if Credible Evidence shows that the consensus among experts regarding the drug, device or medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with the standard means of treatment or diagnosis and the trials are not Research-Urgent as defined except for prescription drugs used to treat cancer when the prescription drug is recognized for treatment of the indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature; or

D. if there is no Credible Evidence available that would support the use of the drug, device, medical treatment or procedure compared to the standard means of treatment or diagnosis except for prescription drugs used to treat cancer when the prescription drug is recognized for treatment of the indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature.

Credible evidence shall mean only published reports and articles in the authoritative medical and scientific literature; the written protocol(s) used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device or medical treatment or procedure; or the written informed consent used by the treating facility or by another facility studying substantially the same drug, device or medical treatment or procedure.

Research-Urgent shall mean a drug, device, medical treatment or procedure that may be covered (even though otherwise excluded by the contract as experimental or investigational) providing the specified criteria outlined in the contract is met.

Contracting providers shall notify the patient when services to be rendered are considered experimental or investigational and may not be covered under the member’s contract. Any patient being billed for services considered experimental or investigational must have a signed waiver in his/her file. The provider must discuss this with the patient in advance, document this in the medical record, and include the GA modifier (waiver on file) on the claim form (electronic or paper). (See Section X. WAIVER FORM) Failure to discuss and obtain a signed waiver in advance of the service will result in provider write-off.

UNIFORM PROVIDER CHARGING PRACTICES


Occasionally BCBSKS receives questions about what constitutes a provider’s usual charge when a provider offers cash customers a discount and what amount to bill BCBSKS. The term “usual charge” is defined in our Contracting Provider Agreements, but to specifically address this question, our policy is as follows:

A. Provider discounts or charging practices based upon individual patients’ situations (for example: patient hardship or professional courtesy) are acceptable and are not considered the provider’s usual charge. If a provider gives a patient a discount for cash, they must bill BCBSKS the same amount.

B. If a provider gives a lower charge to every patient who does not have health insurance, we consider that lower charge to be the “usual charge.”

Because a contracting provider agrees to not bill a BCBSKS member at the time of service, there should never be a circumstance in which a BCBSKS member pays anything other than a deductible, copayment, coinsurance, or non-covered procedure at the time of service. As an additional matter in regard to this point, our payments are timely enough that they are essentially cash for all practical purposes. If we are in fact late with payments, then the remedy is stated under the Prompt Payment law.

C. Agencies such as community mental health centers and county health departments would be allowed to use a sliding scale for charging practices due to agency regulations.

Introduction

There are generally two types of plastic surgery, cosmetic and reconstructive. Cosmetic surgery is performed to improve appearance, not to improve function or ability. The plan does not cover cosmetic surgery. Reconstructive surgery focuses on reconstructing defects of the body or face due to trauma, burns, disease, or birth disorders. Reconstructive surgery is designed to restore or improve function associated with the presence of a defect. This policy outlines when reconstructive surgery may be covered

Note:
The Introduction section is for your general knowledge and is not to be  taken as policy coverage criteria . The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for  providers . A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered

Coding Code Description Medically Necessary Services  CPT
17106 Destruction of cutaneous vascular proliferative lesions (eg,laser technique; less than 10 sq cm
17107 Destruction of cutaneous vascular proliferative lesions (eg , laser technique; 10.0 to 50.0  sq cm
17108 Destruction of cutaneous vascular proliferative lesions (eg , laser technique); over 50.0 sq cm
21125 Augmentation, mandibular body or angle; prosthetic material
21127 Augmentation, mandibular body or angle; with bone graft,  onlay or interpositional (includes obtaining autograft)
21137 Reduction forehead; contouring only
21138 Reduction forehead; contouring and application of prosthetic material or bone graft  (includes obtaining autograft)
21139 Reduction forehead;  contouring and setback of anterior frontal sinus wall
65760 Keratomileusis
65765 Keratophakia
65767 Epikeratoplasty

Cosmetic Services CPT
11920 Tattooing, intradermal introduction of insoluble opaque pigments to correct color  defects of skin, including micropigmentation; 6.0 sq cm or less
11921 Tattooing, intradermal introduction of insoluable opaque pigments to correct color  defects of skin, including micropigmentation; 6.1 sq cm to 20.0 sq cm
11922 Tattooing, intradermal introduction of insoluable opaque pigments to correct color  defects of skin, including micropigmentation; each additional 20.0 sq cm, or part  thereof (List separately in addition to code for primary procedure)
11950 Subcutaneous injection of filling material (eg , collagen); 1cc or less
11951 Subcutaneous injection of filling material (eg , collagen); 1.1 to 5.0 cc
11952 Subcutaneous injection of filling material (eg , collagen); 5.1 to 10.0 cc
11954 Subcutaneous injection of filling material (eg, collagen); over 10.0 cc
11960 Insertion of tissue expander(s) for other than breast, including subsequent expansion
15780 Dermabrasion; total face (eg, for acne scarring, fine wrinkling, rhytids, general  keratosis)
15781 Dermabrasion;  segmental, face
15782 Dermabrasion; regional, other than face
15783 Dermabrasion; superficial, any site, (eg, tattoo removal)
15786 Abrasion; single lesion (eg keratosis, scar)
15787 Abrasion; each additional four lesions or less (List separately in  addition to code for  primary procedure)
15819 Cervicoplasty
15824 Rhytidectomy; forehead
15825 Rhytidectomy; neck with platysmal tightening (platsymal flap, P - flap)
15826 Rhytidectomy; glabellar frown lines
15828 Rhytidectomy; cheek, chin, and neck
15829 Rhytidectomy; superficial musculoapneurotic system SMAS flap
15832 Excision, excessive skin and subcutaneous tissue (includes lipectomy); thigh
15833 Excision, excessive skin and subcutaneous tissue (includes lipectomy); leg
15834 Excision, excessive skin and subcutaneous tissue (includes lipectomy); hip
15835 Excision, excessive skin and subcutaneous tissue (includes lipectomy); buttock
15836 Excision, excessive skin and subcutaneous tissue (includes lipectomy); arm
15837 Excision, excessive  skin and subcutaneous tissue (includes lipectomy); forearm or hand
15838 Excision, excessive skin and subcutaneous tissue (includes lipectomy); submental fat pad
15839 Excision excessive skin and subcutaneous tissue (includes lipectomy); other areas
15847 Excision, excessive skin and subcutaneous tissue (includes lipectomy), abdomen (eg , abdominoplasty) (includes umbilical transposition and fascial plication) (List separately  in addition to code for primary procedure)
15876 Suction assisted lipectomy;  head and neck
15877 Suction assisted lipectomy; trunk
15878 Suction assisted lipectomy; upper extremity
15879 Suction assisted lipectomy; lower extremity
19355 Correction of inverted nipples
21120 Genioplasty; augmentation (autograft, allograft,  prosthetic material)
21121 Genioplasty; sliding osteotomy, single piece
21122 Genioplasty; sliding osteotomies, 2 or more osteotomies (eg , wedge excision or bone  wedge reversal for asymmetrical chin)
21123 Genioplasty; sliding, augmentation with  interpositional bone grafts (includes obtaining  autografts)
40500 Vermilionectomy (lip shave), with mucosal advancement
54360 Plastic operation on penis to correct angulation
56620 Vulvectomy simple; partial
69300 Otoplasty, protruding ear, with or  without size reduction

HCPCS
Q2026 Injection, Radiesse, 0.1 ml
Q2028 Injection, sculptra, 0.5 mg

Cosmetic / Reconstructive CPT

11970 Replacement of tissue expander with permanent prosthesis
11971 Removal of tissue expander(s)  without insertion of prosthesis
19316 Mastopexy
19324 Mammaplasty, augmentation; without prosthetic implant
19325 Mammaplasty, augmentation; with prosthetic implant
19328 Removal of intact mammary implant
19330 Removal of mammary implant material
19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in  reconstruction
19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy or in  reconstruction
19350 Nipple/areola reconstruction
19357 Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion
19366 Breast reconstruction with other technique
19370 Open periprosthetic capsulotomy, breast
19371 Periprosthetic capsulectomy, breast
19380 Revision of reconstructed breast
21088 Impression and custom preparation; facial prosthesis
21188 Reconstruction midface, osteotomies (other than LeFort type) and bone grafts  (includes obtaining autografts)
21280 Medial canthopexy (separate procedure)
21282 Lateral canthopexy

Non - covered Services
CPT
17380 Electrolysis epilation, each 30 minutes
69090 Ear piercing

Note :
CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) . HCPCS  codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Definition of Terms

When specific definitions are not present in a member’s plan, the following definitions will be  applied.

Cosmetic:
In this policy, cosmetic services are those which are primarily intended to preserve or  improve appearance. Cosmetic surgery is performed to reshape normal structures of the body in  order to improve the patient’s appearance or self- esteem.

Physical functional impairment:In this policy, physical functional impairment means a limitation from normal (or baseline level) of physical functioning that may include, but is not  limited to, problems with ambulation, mobilization, communication, respiration, eating,  swallowing, vision, facial expression, skin integrity, distortion of nearby body part(s) or obstruction of an orifice. The physical functional impairment can be due to structure, congenital  deformity, pain, or other causes. Physical functional impairment excludes social, emotional and psychological impairments or potential impairments

Reconstructive surgery:

In this policy, reconstructive surgery refers to surgeries performed on abnormal structures of the body, caused by congenital defects, developmental a bnormalities, trauma, infection, tumors or disease. It is generally performed to improve function. Determination of Eligibility for Coverage The final determination of eligibility for coverage should be based on application of the specific contract language based on the etiology of the defect and the presence or absence of documented physical functional impairment .

Administering the Contract Language ( also seeBenefit Application)

The  following general principles describe the issues to be determined in properly administering  the contract language.

1.The eligibility of a service for coverage may be based on either a specific benefit addressing cosmetic or reconstructive services or on its specific exemption or exclusion for cosmetic or  reconstructive services or both.

2. Cosmetic services are usually considered to be those that are primarily to restore  appearance and that otherwise do not meet the definition of reconstructive.

The definition  of reconstructive may be based on two distinct factors:

o Whether the service is primarily indicated to improve or correct a functional impairment or is primarily to improve appearance; and
o The etiology of the defect (eg, congenital anomaly, anatomic variant, result of trauma, post-therapeutic intervention, disease process).

3.  The presence or absence of a functional impairment is a critical point in interpreting coverage eligibility. For musculoskeletal conditions, the concept of a functional impairment is straightforward. However, when considering dermatologic conditions, the function of the skin is more difficult to define. Procedures designed to enhance the appearance of the skin are typically considered cosmetic
 

CPT Code - Description

0301T Destruction/reduction of malignant breast tumor with externally applied focused microwave, including interstitial placement of disposable catheter with combined temperature monitoring probe and microwave focusing sensocatheter under ultrasound thermotherapy guidance

19499 Unlisted procedure, breast

32998 Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, radiofrequency, unilateral

32999 Unlisted procedure, lungs and pleura

47382 Ablation, 1 or more liver tumor(s), percutaneous, radiofrequency

47399 Unlisted procedure, liver

49999 Unlisted procedure, abdomen, peritoneum and omentum

50592 Ablation, 1 or more renal tumor(s), percutaneous, unilateral, radiofrequency

53899 Unlisted procedure, urinary system (for renal tumors)

60699 Unlisted procedure, endocrine system (for adrenal or thyroid tumors)

76940 Ultrasound guidance for, and monitoring of, parenchymal tissue ablation





Microwave Tumor Ablation

Introduction
Ablation refers to destroying tumors without removing them. Microwave ablation is a method of trying to treat tumors using microwave energy. A small probe is placed into the tumor. The probe sends out microwave energy. The microwaves cause enough heat to kill tumor cells. Medical studies show that while this technique can destroy tumors at a particular location, cancer recurrence at other sites is common, depending on the stage and type of cancer. More studies are needed to show which patients would benefit the most from this treatment, as well as explaining why this treatment should be used instead of other proven methods. For these reasons, microwave ablation of tumors is considered investigational (unproven).

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Service Investigational Microwave ablation (MWA) Microwave ablation (MWA) of primary and metastatic tumors is considered investigational. Coding

According to an American Medical Association publication (Clinical Examples in Radiology, 2012, 8, [3}), “microwave is part of the radiofrequency spectrum, and simply uses a different part of the radiofrequency spectrum to develop heat energy to destroy abnormal tissue.” Therefore, AMA recommends that microwave ablation should be reported using the CPT codes for radiofrequency ablation as noted in the coding table below.

Related Information
This policy does not address MWA for the treatment of splenomegaly or ulcers or as a surgical coagulation tool. Evidence Review

Description

Microwave ablation (MWA) is a technique that is used to destroy tumors and soft tissue. It generates microwave energy to create thermal coagulation and localized tissue necrosis, and has been used to treat tumors not amendable to resection. It has also been used to treat patients ineligible for surgery due to age, comorbidities, or poor general health. MWA may be performed as an open procedure, laparoscopically, percutaneously, or thoracoscopically under image guidance (eg, ultrasound, computed tomography, magnetic resonance imaging) with sedation, or local or general anesthesia. This technique is also referred to as microwave coagulation therapy.

Background
MWA is a technique that uses microwave energy to induce an ultra-high speed, 915 MHz or 2.450 MHz (2.45 GHz), alternating electric field, which causes water molecules to rotate and create heat. This results in thermal coagulation and localized tissue necrosis. In MWA, a single microwave antenna or multiple antennas connected to a generator are inserted directly into the tumor or tissue to be ablated; energy from the antennas generates friction and heat. The local heat coagulates the tissue adjacent to the probe, resulting in a small, 2- to 3 -cm elliptical area  (5 x 3 cm) of tissue ablation. In tumors greater than 2 cm in diameter, 2 to 3 antennas may be used simultaneously to increase the targeted area of MWA and shorten operative time. Multiple antennas may also be used simultaneously to ablate multiple tumors. Tissue ablation occurs quickly, within 1 minute after a pulse of energy, and multiple pulses may be delivered within a treatment session, depending on tumor size. The cells killed by MWA are typically not removed but are gradually replaced by fibrosis and scar tissue. If there is local recurrence, it occurs at the margins. Treatment may be repeated as needed. MWA may be used to:

1. Control local tumor growth and prevent recurrence
2. Palliate symptoms
3. Extend survival duration

MWA is similar to radiofrequency (RFA) and cryosurgical ablation. However, MWA has potential advantages over RFA and cryosurgical ablation. In MWA, the heating process is active, which produces higher temperatures than the passive heating of RFA and should allow for more complete thermal ablation in less time. The higher temperatures reached with MWA (>100°C) can overcome the “heat sink” effect in which tissue cooling occurs from nearby blood flow in large vessels, potentially resulting in incomplete tumor ablation. MWA does not rely on the conduction of electricity for heating and, therefore, does not flow electrical current through patients and does not require grounding pads, because there is no risk of skin burns. Additionally, MWA does not produce electric noise, which allows ultrasound guidance during the procedure without interference, unlike RFA. Finally, MWA can take less time than RFA, because multiple antennas can be used simultaneously.

Adverse Events

Complications from MWA are usually considered mild and may include pain and fever. Other potential complications associated with MWA include those caused by heat damage to normal tissue adjacent to the tumor (eg, intestinal damage during MWA of the kidney or liver), structural damage along the probe track (eg, pneumothorax as a consequence of procedures on the lung), liver enzyme elevation, liver abscess, ascites, pleural effusion, diaphragm injury or secondary tumors if cells seed during probe removal. MWA should be avoided in pregnant women because potential risks to the patient and/or fetus have not been established. It should also be avoided in patients with implanted electronic devices such as implantable pacemakers that may be adversely affected by microwave power output.

Applications

MWA was first used percutaneously in 1986 as an adjunct to liver biopsy. Since then, MWA has been used to ablate tumors and other tissues in order to treat many conditions. These have included hepatocellular carcinoma, breast cancer, colorectal cancer metastatic to the liver, renal cell carcinoma, renal hamartoma, adrenal malignant carcinoma, non-small-cell lung cancer, intrahepatic primary cholangiocarcinoma, secondary splenomegaly and hypersplenism, abdominal tumors, and other tumors not amenable to resection. Well-established local or systemic treatment alternatives are available for each of these malignancies. The potential advantages of MWA for these cancers include improved local control and other advantages common to any minimally invasive procedure (eg, preserving normal organ tissue, decreasing morbidity, shortening length of hospitalization). MWA also has been investigated as primary and/or palliative treatment for unresectable hepatic tumors, and also as a bridge to liver transplantation. In the latter setting, MWA is being assessed to determine whether it can reduce the incidence of tumor progression while awaiting liver transplantation and thus maintain a patient’s candidacy for the transplant.

Summary of Evidence

For individuals who have an unresectable primary or metastatic tumor (eg, breast, hepatic [primary or metastatic], pulmonary, renal) who receive MWA, the evidence includes case series, observational studies, cohort studies, randomized controlled trials (RCTs), and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, symptoms, quality of life, and treatment-related mortality and morbidity. Available studies have shown that MWA results in a wide range of complete tissue ablation (50%-100%) depending on tumor size, with complete ablation common and nearing 100% with smaller tumors (eg, less than or equal to 3 cm). Tumor recurrence rates at ablated sites are very low. However, tumor recurrence at nonablated sites is common and may correlate with disease state (eg, in hepatocellular carcinoma). Intraoperative and postoperative minor and major complications are low, especially when tumors are smaller and accessible. Patient selection criteria and rationale for using MWA over other established techniques (eg, surgical resection, radiofrequency ablation) are needed. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials

Code Description CPT

0078U Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder (new code effective 10/1/18)

81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)

81226 CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6)

81291 MTHFR (5,10-methylenetetrahydrofolate reductase) (eg, hereditary hypercoagulability) gene analysis, common variants (eg, 677T, 1298C)

81479 Unlisted molecular pathology procedure



Pharmacogenetic Testing for Pain Management

Introduction

When it comes to treating pain, there are a lot of different choices. These include things like over-the-counter remedies like acetaminophen and ibuprofen, medications that are rubbed onto the skin, and prescription drugs known as opioids. Antidepressants and antiseizure medications are also sometimes used to help with pain. Managing acute (sudden and intense) and chronic (long lasting) pain can be challenging.  Each person not only has a different response to pain, but they may also have a different response to pain medication. In short, what works for one person may not work for another. A person’s genetics may affect pain perception and how the body processes medications. Genetic tests have been developed to try to find out how a person might respond to drugs to treat pain. These genetic tests are investigational (unproven). There is not enough medical evidence in published studies to show whether these genetic tests will improve overall health results.

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 



Policy Coverage Criteria 

Service Investigational
Genetic testing for pain management

Genetic testing for pain management is considered investigational for all indications.
This policy does not address testing for congenital insensitivity to pain.
This policy is not intended to address testing that is limited to cytochrome P450 genotyping, which is addressed in a separate medical policy, (see Related Policies).
Commercially-available genetic tests for pain management consist of single-nucleotide variants (SNVs) or (less commonly) individual SNV testing. SNVs implicated in pain management include the following (see also Table 1):

* 5HT2C (serotonin receptor gene)
* 5HT2A (serotonin receptor gene)
* SLC6A4 (serotonin transporter gene)
* DRD1 (dopamine receptor gene)
* DRD2 (dopamine receptor gene)
* DRD4 (dopamine receptor gene)
* DAT1 or SLC6A3 (dopamine transporter gene)
* DBH (dopamine beta-hydroxylase gene)
* COMT (catechol O-methyltransferase gene)

* MTHFR (methylenetetrahydrofolate reductase gene)
* *-aminobutyric acid (GABA) A receptor gene
* OPRM1 (µ-opioid receptor gene)
* OPRK1 (*-opioid receptor gene)
* UGT2B15 (uridine diphosphate glycosyltransferase 2 family, member 15)
* Cytochrome p450 genes: CYP2D6, CYP2C19, CYP2C9, CYP3A4, CYP2B6, CYP1A2


 Evidence Review 

Description 

While multiple pharmacologic therapies are available for the management of acute and chronic pain, there is a lot of variability in the person’s response to pain, particularly in the management of chronic pain, and in the presence of adverse events (AEs). This has prompted interest in better targeting pain therapies through the use of pharmacogenetic testing of genes relevant to analgesic pharmacokinetics or pharmacodynamics. A number of panels of genetic tests for genes that have shown some association with the pharmacokinetics or pharmacodynamics of analgesic medications have been developed to aid in the management of pain.

Background

Pain is a universal human experience and an important contributor to outpatient and inpatient medical visits. The Institute of Medicine (IOM) reported in 2011 that common chronic pain conditions affect at least 116 million adults in the United States.
1
 Chronic pain may be due to cancer or chronic noncancer conditions. These noncancer conditions may include migraines, low back pain, or fibromyalgia. Multiple therapeutic options exist to manage pain, including pharmacotherapies, behavioral modifications, physical and occupational therapy, and complementary/alternative therapies. Nonetheless, the IOM has reported that many individuals receive inadequate pain prevention, assessment, and treatment. Given that pain is an individual and subjective experience, assessing and predicting response to pain interventions, including pain medications, is challenging.

Pain Management

A variety of medication classes are available to manage pain. These include non-opioid analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), and opioid analgesics which target central nervous system pain perception. Adjuvant medications such as antiepileptic drugs (eg, gabapentin, pregabalin), antidepressants (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors), and topical analgesics have also been used. The management of chronic pain has been driven, in part, by the World Health Organization’s analgesic ladder for pain management, which was developed for the management of cancer-related pain but has been applied to the management of other forms of pain. The ladder outlines a stepped approach to pain management, beginning with non-opioid analgesia and proceeding to a weak opioid (eg, codeine), with or without an adjuvant for persisting pain. If these fail to control pain, the next step is a strong opioid (eg, fentanyl, morphine), with or without an adjuvant for persisting or worsening pain. Various opioids are available in short- and long-acting preparations and administered through variety of routes, including oral, intramuscular, subcutaneous, sublingual, and transdermal.



Pharmacologic Treatment

For acute pain management, particularly postoperative pain, systemic opioids and non-opioid analgesics remain the mainstay of therapy. However, there has been growing interest in using alternative, nonsystemic treatments in addition to or instead of systemic opioids. These options include neuraxial anesthesia, a type of regional anesthesia including epidural or intrathecal opioid injection. This type of anesthesia may be managed by a patient-controlled anesthesia pump. Postoperative peripheral nerve blocks may also be used.

While available pain management therapies are effective for many patients, there is a great deal of variability in pain response, particularly in the management of chronic pain. In addition, many opioids have a significant risk of adverse events (AEs), ranging from mild (eg, constipation) to severe (eg, respiratory depression) and are associated with a risk of dependence, addiction, and abuse. Limitations in currently available pain management techniques have led to interest in the use of pharmacogenetics to improve the targeting of therapies in order to predict and avoid AEs.

Genetics of Pain Management

Genetic factors may influence many aspects of pain and pain control, including predisposition to conditions that lead to pain, pain perception, and the development of comorbid conditions that may affect pain perception. The currently available genetic tests relevant to pain management look at single-nucleotide variants (SNVs) in single genes potentially related to pharmacokinetic or pharmacodynamic processes. 

Broadly speaking, genes related to these clinical scenarios include those involved in neurotransmitter uptake, clearance, and reception; opioid reception; and hepatic drug metabolism. Panels of genetic tests have been developed and have been proposed for use in the management of pain. Genes identified as being relevant to pain management and that are included in currently available panels are summarized in Table 1.



Commercially Available Genetic Tests for Pain Management
Several test labs market panels of tests or individual tests designed to address one or more aspects of pain management, including but not limited to drug selection, drug dosing, or prediction of AEs. Specific variants included in the panels are shown in Table 2.
* GeneSight® Analgesic (Assurex Health, Mason, OH) is a genetic panel test that is intended to analyze “how patients’ genes can affect their metabolism and possible response to FDA [U.S. Food and Drug Administration]-approved opioids, NSAIDs and muscle relaxants commonly used to treat chronic pain.”

Results are provided with a color-coded report based on efficacy and tolerability, which displays which medications should be used as directed, used with caution, or used with increased caution and more frequent monitoring.


The company’s website does not specify the testing methods. Publications describing other tests provided by the company specify that testing is conducted via SNP sequencing performed via multiplex polymerase chain reaction.

* Proove Biosciences (Irvine, CA) offers several genetic panels that address pain control. The Proove® Opioid Risk Panel is a panel of 11 genes that is intended to predict opioid abuse and failure of opioid therapy. Genetic testing results are provided along with an overall “Dependence Risk Index.”

The company also markets the Proove® Pain Perception panel, which is a panel test for SNPs in several genes related to pain perception, including COMT and at least 3 other genes. Results are provided with a report which stratifies patients’ pain sensitivity based on COMT haplotype.

In addition, Proove offers panels designed to predict good and poor responders to opioid therapies and non-opioid pain therapies. These are the Proove® Opioid Response

Coding 

The use of circulating tumor DNA and/or circulating tumor cells is considered investigational for all indications (see Table 1 for examples of liquid biopsy tests).

Code Description CPT

81479 Unlisted molecular pathology procedure

86152 Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood);

86153 Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when required





Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)

Introduction
Liquid biopsy is a when a blood sample (rather than a piece of tissue) is used to test for cancer cells or small genetic cancer pieces mixing in the blood. The blood sample is taken from the arm and is tested for cells or genetic pieces that cancers shed into the bloodstream. Identifying tumor cell material in the blood might help to diagnose cancer, track changes in a cancer over time or help select the right type of cancer treatment. However, there is not enough information from clinical studies to be certain that this works as well as a tissue biopsy in most people, because we don’t yet know that this works as well as tissue biopsy. This treatment is not yet proven.

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 
Policy Coverage Criteria 

Procedure Investigational

Circulating Tumor DNA, Circulating Tumor Cells 



Related Information 

This policy does not address the use of blood-based testing for epidermal growth factor receptor variants in non-small-cell lung cancer or the use of AR-V7 circulating tumor cells for metastatic prostate cancer.


Description

Circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) in peripheral blood, referred to as “liquid biopsy,” have several potential uses for guiding therapeutic decisions in patients with cancer or being screened for cancer. This policy evaluates uses for liquid biopsies not addressed in a separate policy. If a separate policy exists, then conclusions reached there supersede conclusions here.

Background
Liquid biopsy refers to analysis of circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) as methods of noninvasively characterizing tumors and tumor genome from the peripheral blood.

Circulating Tumor DNA

Normal and tumor cells release small fragments of DNA into the blood, which is referred to as cell-free DNA (cfDNA). cfDNA from nonmalignant cells is released by apoptosis. Most cell-free tumor DNA is derived from apoptotic and/or necrotic tumor cells, either from the primary tumor, metastases, or CTCs.

Unlike apoptosis, necrosis is considered a pathologic process, and generates larger DNA fragments due to incomplete and random digestion of genomic DNA. The length or integrity of the circulating DNA can potentially distinguish between apoptotic and necrotic origin. ctDNA can be used for genomic characterization of the tumor.

Circulating Tumor Cells 

Intact CTCs are released from a primary tumor and/or a metastatic site into the bloodstream. The half-life of a CTC in the bloodstream is short (1-2 hours), and CTCs are cleared through extravasation into secondary organs.

Most assays detect CTCs through the use of surface epithelial markers such as EpCAM and cytokeratins. The primary reason for in detecting CTCs is prognostic, through quantification of circulating levels.


Detecting ctDNA and CTCs

Detection of ctDNA is challenging because ctDNA is diluted by nonmalignant circulating DNA and usually represents a small fraction (<1 approaches="" are="" cfdna.="" eg="" methods="" more="" nbsp="" needed.="" of="" p="" sanger="" sensitive="" sequencing="" standard="" than="" the="" therefore="" total="">
Highly sensitive and specific methods have been developed to detect ctDNA, for both singlenucleotide mutations (eg, BEAMing [which combines emulsion polymerase chain reaction [PCR] with magnetic beads and flow cytometry] and digital PCR) and copy-number variants. Digital genomic technologies allow for enumeration of rare mutant variants in complex mixtures of DNA.

Approaches to detecting ctDNA can be considered targeted, which includes the analysis of known genetic mutations from the primary tumor in a small set of frequently occurring driver mutations, which can impact therapy decisions or untargeted without knowledge of specific variants present in the primary tumor, and include array comparative genomic hybridization, next-generation sequencing, and whole exome and genome sequencing.

CTC assays usually start with an enrichment step that increases the concentration of CTCs, either by biologic properties (expression of protein markers) or physical properties (size, density, electric charge). CTCs can then be detected using immunologic, molecular, or functional assays.


Summary of Evidence

For individuals who have advanced cancer who receive testing of ctDNA to select targeted treatment, the evidence includes observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess ctDNA, the clinical validity of each commercially available test must be established independently, and these data are lacking. Published studies reporting clinical outcomes and/or clinical utility are lacking. The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether variant analysis of ctDNA can replace variant analysis of tissue. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have advanced cancer who receive testing of CTCs to select targeted treatment, the evidence includes observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess CTCs, the clinical validity of each commercially available test must be established independently, and these data are lacking. Published studies reporting clinical outcomes and/or clinical utility are lacking. The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether the use of CTCs can replace variant analysis of tissue. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cancer who receive testing of ctDNA to monitor treatment response, the evidence includes observational studies. Relevant outcomes are overall survival, diseasespecific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess ctDNA, the clinical validity of each commercially available test must be established independently, and these data are lacking. Published studies reporting clinical outcomes and/or clinical utility are lacking. The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether the use of ctDNA should be used to monitor treatment response. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cancer who receive testing of CTCs to monitor treatment response, the evidence includes a randomized controlled trial, observational studies, and systematic reviews of observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess CTCs, the clinical validity of each commercially available test must be established independently, and these data are lacking. The available randomized controlled trial found no effect on overall survival when patients with persistently increased CTC levels after first-line chemotherapy were switched to an alternative cytotoxic therapy. Other studies reporting clinical outcomes and/or clinical utility are lacking.

The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether the use of CTCs should be used to monitor treatment response. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have received curative treatment for cancer who receive testing of ctDNA to predict risk of relapse, the evidence includes observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess ctDNA, the clinical validity of each commercially available test must be established independently, and these data are lacking. Published studies reporting clinical outcomes and/or clinical utility are lacking. The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether the use of ctDNA should be used to predict relapse response. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have received curative treatment for cancer who receive testing of CTCs to predict risk of relapse, the evidence includes observational studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, morbid events, and medication use. Given the breadth of methodologies available to assess CTCs, the clinical validity of each commercially available test must be established independently, and these data are lacking. Published studies reporting clinical outcomes and/or clinical utility are lacking. The uncertainties concerning clinical validity and clinical utility preclude conclusions about whether the use of CTCs should be used to predict relapse response. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are asymptomatic and at high risk for cancer who receive testing of ctDNA to screen for cancer, no evidence was identified. Relevant outcomes are overall survival, diseasespecific survival, test accuracy, and test validity. Published data on clinical validity and clinical 1>

Code Description CPT

81200 ASPA (aspartoacylase) (eg, Canavan disease) gene analysis, common variants (e.g., E285A, Y231X)

81223 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; full gene sequence

81255 HEXA (hexosaminidase A [alpha polypeptide]) (eg, Tay-Sachs disease) gene analysis, common variants (eg, 1278insTATC, 1421+1G>C, G269S)

81257 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis, for common deletions or variant (eg, Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2,

81599 Unlisted multianalyte assay with algorithmic analysis

89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for preimplantation genetic diagnosis); less than or equal to 5 embryos

89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for preimplantation genetic diagnosis); greater than 5 embryos

89398 Unlisted reproductive medicine laboratory procedure

Specific CPT codes describe the embryo biopsy procedure (89290-89291). Additional CPT codes will be required for the genetic analysis and will vary by technique used to perform the genetic analysis. 




Preimplantation Genetic Testing in Embryos


Introduction
In vitro fertilization is the process of combining eggs and sperm in a lab dish to create a fertilized egg (an embryo) and later implanting it into the uterus to complete the pregnancy. Before implantation, one or more cells from the embryo may be tested to see if there are problems with its genes or chromosomes. “Preimplantation genetic diagnosis” testing looks at the genes to see if the embryo carries a genetic disease such as cystic fibrosis. “Preimplantation genetic screening” looks to see if there are too few or too many chromosomes. This policy describes when either type of preimplantation genetic testing may be considered medically necessary.  

Note:   The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. 



Policy Coverage Criteria 

Procedure Medical Necessity

Preimplantation genetic diagnosis (PGD)

The procedure to obtain the cell sample for PGD (ie, the embryo biopsy) is considered medically necessary when the criteria below for PGD are met. However, the IVF procedure (ie, the procedures and services, including intracytoplasmic sperm injection [ICSI], required to create the embryos to be tested and the transfer of the appropriate embryos back to the uterus after testing) is covered only for persons with assisted fertility benefits for IVF. Please check the member contract and benefit descriptions for coverage of assisted fertility techniques such as IVF.  Preimplantation genetic diagnosis (PGD) may be considered medically necessary as an alternative to amniocentesis or chorionic villus sampling in couples undergoing IVF who meet one of the following criteria: * For evaluation of an embryo at an identified elevated risk of a
genetic disorder such as when: o Both partners are known carriers of a single-gene
autosomal recessive disorder o One partner is a known carrier of a single-gene autosomal
recessive disorder and the partners have an offspring who has been diagnosed with that recessive disorder 
o One partner is a known carrier of a single-gene autosomal dominant disorder
o One partner is a known carrier of a single X-linked disorder OR * For evaluation of an embryo at an identified elevated risk of
structural chromosomal abnormality such as if one parent has a balanced or unbalanced chromosomal translocation.


Procedure Medical Necessity
Preimplantation genetic screening (PGS), gender selection


Note: When the specific criteria noted above are met, the Plan will cover the embryo biopsy procedure to obtain the cell and genetic test associated with PGD under the medical benefit.

Preimplantation genetic screening (PGS) is considered not medically necessary when testing embryos solely for nonmedical gender selection or selection of other nonmedical traits.
Procedure Investigational
Preimplantation genetic diagnosis (PGD)
Preimplantation genetic screening (PGS)

Coding 
 
Preimplantation genetic diagnosis (PGD) as an alternative to amniocentesis or chorionic villus sampling is considered investigational in patients/couples who are undergoing IVF in all situations other than those specified above.

Preimplantation genetic screening (PGS) as an alternative to amniocentesis or chorionic villus sampling is considered investigational in patients/couples who are undergoing IVF in all situations when used to screen for potential genetic abnormalities in couples without a specific known inherited disorder.


Related Information 

Additional Information
In some cases involving a single X-linked disorder, determination of the gender of the embryo provides sufficient information for excluding or confirming the disorder.
The severity of the genetic disorder is also a consideration. At present, many cases of preimplantation genetic diagnosis (PGD) have involved lethal or severely disabling conditions with limited treatment opportunities, such as Huntington chorea or Tay-Sachs disease. Cystic fibrosis is another condition for which PGD has been frequently performed. However, cystic fibrosis has a variable presentation and can be treatable. The range of genetic testing that is performed on amniocentesis samples as a possible indication for elective abortion may serve as a guide.

This policy does not address the myriad ethical issues associated with preimplantation genetic testing (PGT) that, it is hoped, have involved careful discussion between the treated couple and the physician. For some couples, the decision may involve the choice between the risks of an in vitro fertilization procedure and deselection of embryos as part of the PGT treatment versus normal conception with the prospect of amniocentesis and an elective abortion.



Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA  Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence  Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.


Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex.

Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review 

Description
Preimplantation genetic testing (PGT) involves analysis of biopsied cells as part of an assisted reproductive procedure. It is generally considered to be divided into 2 categories:
1. Preimplantation genetic diagnosis (PGD) is used to detect a specific inherited disorder in conjunction with in vitro fertilization (IVF) and aims to prevent the birth of affected children to couples at high risk of transmitting a disorder
2. Preimplantation genetic screening (PGSin conjunction with in vitro fertilization (IVF)  involves testing for potential genetic abnormalities for couples without a specific known inherited disorder.

Background
Preimplantation Genetic Testing

Preimplantation genetic testing (PGT) describes various adjuncts to an assisted reproductive procedure in which either maternal or embryonic DNA is sampled and genetically analyzed, thus permitting deselection of embryos harboring a genetic defect before implantation of an embryo into the uterus. The ability to identify preimplantation embryos with genetic defects before implantation provides an alternative to amniocentesis, chorionic villus sampling(CVS), and selective pregnancy termination of affected fetuses. Preimplantation genetic testing  is generally categorized as either diagnostic (preimplantation genetic diagnosis [PGD]) or screening (preimplantation genetic screening [PGS]). PGD is used to detect genetic evidence of a specific inherited disorder, in the oocyte or embryo, derived from mother or couple, respectively, that has a high risk of transmission. PGS is not used to detect a specific abnormality but instead uses similar techniques to identify a number of genetic abnormalities in the absence of a known heritable disorder. This terminology, however, is not used consistently (eg, some authors use PGD when testing for a number of possible abnormalities in the absence of a known disorder).

Biopsy

Biopsy for PGD can take place at 3 stages: the oocyte, cleavage stage embryo, or the blastocyst. In the earliest stage, both the first and second polar bodies are extruded from the oocyte as it completes the meiotic division after ovulation (first polar body) and fertilization (second polar body). This strategy thus focuses on maternal chromosomal abnormalities. If the mother is a known carrier of a genetic defect and genetic analysis of the polar body is normal, then it is assumed that the genetic defect was transferred to the oocyte during meiosis.

Biopsy of cleavage stage embryos or blastocysts can detect genetic abnormalities arising from either the maternal or paternal genetic material. Cleavage stage biopsy takes place after the first few cleavage divisions when the embryo is composed of 6 to 8 cells (ie, blastomeres). Sampling involves aspiration of one and sometimes 2 blastomeres from the embryo. Analysis of 2 cells may improve diagnosis but may also affect the implantation of the embryo. In addition, a potential disadvantage of testing at this phase is that mosaicism might be present. Mosaicism refers to genetic differences among the cells of the embryo that could result in an incorrect interpretation if the chromosomes of only a single cell are examined.

The third option is sampling the embryo at the blastocyst stage when there are about 100 cells. Blastocysts form 5 to 6 days after insemination. Three to 10 trophectoderm cells (outer layer of the blastocyst) are sampled. A disadvantage is that not all embryos develop to the blastocyst phase in vitro and, when they do, there is a short time before embryo transfer needs to take place. Blastocyst biopsy has been combined with embryonic vitrification to allow time for test results to be obtained before the embryo is transferred.



Analysis and Testing

The biopsied material can be analyzed in a variety of ways. Polymerase chain reaction or other amplification techniques can be used to amplify the harvested DNA with subsequent analysis for single genetic defects. This technique is most commonly used when the embryo is at risk for a specific genetic disorder such as Tay-Sachs disease or cystic fibrosis. Fluorescent in situ hybridization (FISH) is a technique that allows direct visualization of specific (but not all) chromosomes to determine the number or absence of chromosomes. This technique is most commonly used to screen for aneuploidy, sex determination, or to identify chromosomal translocations. FISH cannot be used to diagnose single genetic defect disorders. However, molecular techniques can be applied with FISH (eg, microdeletions, duplications) and, thus, single-gene defects can be recognized with this technique. Performing PGS using FISH is known as PGS version 1.

Another more recent approach is array comparative genome hybridization testing at either the 8-cell or, more often, the blastocyst stage, also known as PGS version 2. Unlike FISH analysis, hybridization allows for 24 chromosome aneuploidy screening, as well as more detailed screening for unbalanced translocations and inversions and other types of abnormal gains and losses of chromosomal material. Other PGS version 2 methods include single nucleotide variant microarrays and quantitative polymerase chain reaction.

Next-generation sequencing such as massively parallel signature sequencing has potential applications to prenatal genetic testing and is grouped with PGS version 2 techniques in some literature and referred to as PGS version 3 in other literature.

Embryo Classification

Three general categories of embryos have undergone preimplantation genetic testing, which are discussed in the following subsections.

Embryos at Risk for a Specific Inherited Single Genetic Defect 
Inherited single-gene defects fall into 3 general categories: autosomal recessive, autosomal dominant, and X-linked. When either the mother or father is a known carrier of a genetic defect, embryos can undergo PGD to deselect embryos harboring the defective gene. Sex selection of a female embryo is another strategy when the mother is a known carrier of an X-linked disorder for which there is no specific molecular diagnosis. The most common example is female carriers of fragile X syndrome.
In this scenario, PGD is used to deselect male embryos, half of which would be affected. PGD could also be used to deselect affected male embryos. While there is a growing list of single genetic defects for which molecular diagnosis is possible, the most common indications include cystic fibrosis, ß-thalassemia, muscular dystrophy, Huntington disease, hemophilia, and fragile X disease. It should be noted that when PGD is used to deselect affected embryos, the treated couple is not technically infertile but is undergoing an assisted reproductive procedure for the sole purpose of PGD. In this setting, PGD may be considered an alternative to selective termination of an established pregnancy after diagnosis by amniocentesis or chorionic villus sampling.

Embryos at a Higher Risk of Translocations

Balanced translocations occur in 0.2% of the neonatal population but at a higher rate in infertile couples or in those with recurrent spontaneous abortions. PGD can be used to deselect embryos carrying the translocations, thus leading to an increase in fecundity or a decrease in the rate of spontaneous abortion.

Identification of Aneuploid Embryos 

Implantation failure of fertilized embryos is common in assisted reproductive procedures; aneuploidy of embryos is thought to contribute to implantation failure and may also be the cause of recurrent spontaneous abortion. The prevalence of aneuploid oocytes increases in older women. These age-related aneuploidies are mainly due to nondisjunction of chromosomes during maternal meiosis. Therefore, PGS has been explored as a technique to deselect aneuploid oocytes in older women and is also known as PGD for aneuploidy screening. FISH analysis of extruded polar bodies from the oocyte or no blastomeres at day 3 of embryo development was  initially used to detect aneuploidy (PGS version 1). A limitation of FISH is that analysis is limited to a restricted number of proteins. More recently, newer PGS methods have been developed and are known collectively as PGS version 2. These methods allow for all chromosomes analysis with genetic platforms including array comparative genomic hybridization and single-nucleotide variant chain reaction analysis. Moreover, in addition to older women, PGS has been proposed for women with repeated implantation failures.

Code Description CPT

81201 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence

81202 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; known familial variants

81203 APC (adenomatous polyposis coli) (eg, familial adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants

81210 BRAF (v-raf murine sarcoma viral oncogene homolog B1) (eg, colon cancer), gene analysis, V600E variant

81288 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis 

81292 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81293 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants

81294 MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants

81295 MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary nonpolyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis

81296 MSH2 (muts honolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, known familial variants

81297 MSH2 (muts honolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, duplication/deletion variants

81298 MSH2 (muts honolog 2, colon cancer, nonpolyposis type 1) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, full sequence analysis

81299 MSH6 (muts honolog 6 [e. coli]) (eg, hereditary non-polyposis colorectal cancer, lynch syndrome) gene analysis, known familial variants

81300 MSH6 (muts honolog 6 [e. coli]) (eg, hereditary non-polyposis colorectal cancer, lynch syndrome) gene analysis, duplication/deletion variants

81301 Microsatellite instability analysis (eg, hereditary non-polyposis colorectal cancer, lynch syndrome) of markers for mismatch repair deficiency (eg, BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed

81317 PMS2 (postmeiotic segregation increased 2 [ s. cerevisiae]) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, full sequence analysis

81318 PMS2 (postmeiotic segregation increased 2 [ s. cerevisiae]) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, known familial variants

81319 PMS2 (postmeiotic segregation increased 2 [ s. cerevisiae]) (eg, hereditary nonpolyposis colorectal cancer, lynch syndrome) gene analysis, duplication/deletion variants

81406 Molecular pathology procedure, Level 7 (eg, analysis of 11-25 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 26-50 exons, cytogenomic array analysis for neoplasia)

81435 Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2

81436 Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis polyposis); duplication/deletion gene analysis panel, must include analysis of at least 8 genes, including APC, MLH1, MSH2, MSH6, PMS2, EPCAM, CHEK2, and MUTYH


Genetic Testing for Lynch Syndrome and Other Inherited Colon Cancer Syndromes


Introduction

Five to ten percent of all cancers may be inherited. Several genes have been identified that are associated with colon cancer and are passed from parents to children. Genetic testing may help determine the risk of colon cancer in family members and guide the frequency of colon cancer screening tests. This policy describes when those tests are covered based on the latest scientific studies. Some of these tests need to be pre-approved by the health plan. See Coverage Criteria for more specific information.

Note:  The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Testing Medical Necessity Lynch Syndrome(Also known as hereditary non-polyposis colorectal cancer or HNPC)
Initial screening Screening for Lynch syndrome as an initial evaluation of tumor tissue: * ALL cases of colorectal cancer, regardless of age screened for
Genetic testing  (eg, COLARIS® (Myriad))

Lynch Syndrome using either microsatellite instability (MSI) or immunohistochemical (IHC), with or without BRAF/MLH1 promoter methylation testing, may be considered medically necessary as an initial evaluation of tumor tissue .

Note: MSI/IHC testing prior to actual genetic testing for Lynch syndrome is recommended, but not required.
Genetic testing for Lynch syndrome (MLH1, MSH2, MSH6, PMS2 sequence analysis) may be considered medically necessary when the member meets ANY ONE of the following criteria: * A colon cancer diagnosis with a positive result from MSI/IHC
test (see Lynch syndrome initial screening, above) OR * Colorectal carcinoma (CRC) diagnosed in a patient who is less
than 50 years old OR * Endometrial cancer diagnosed in a patient who is less than 50
years old OR * All of the Amsterdam II clinical criteria are met (see below) OR * One of the revised Bethesda guidelines are met (seebelow) OR * One first-degree or second-degree relative* with a Lynch
syndrome mutation (genes MLH1, MSH2, MSH6, PMS2) OR * Personal history of endometrial cancer diagnosed at age 51-60

and one first-degree relative diagnosed with a Lynchassociated cancer.**
*For the purposes of familial assessment, first- or second-degree relatives are blood relatives on the same side of the family (maternal or paternal). The maternal and paternal sides of the


Testing Medical Necessity

family should be considered independently for familial patterns of cancer. *First-degree relatives are parents, siblings, and offspring. Second-degree relatives are aunts, uncles, grandparents, niece, nephews or half-siblings.
**Lynch-associated cancers include colorectal, endometrial, gastric, ovarian, pancreas, bladder, ureter and renal pelvis, brain (usually glioblastoma as seen in Turcot syndrome), and small intestinal cancers, as well as sebaceous gland adenomas and keratoacanthomas in Muir-Torre syndrome.
 Genetic testing for Lynch syndrome is considered investigational when the member has not met at least one of the criteria listed above.
Familial Adenomatous Polyposis (FAP) and Associated Variants
Adenosis polyposis coli (APC) (eg, Colaris AP® (Myriad))
MYH/MUTYH-Associated Polyposis (MAP)
Adenosis polyposis coli (APC) genetic testing is considered medically necessary for ANY ONE of the following indications: * Personal history of greater than 10 cumulative colonic
adenomatous polyps OR * One first-degree relative diagnosed with familial adenomatous

polyposis (FAP) or with a documented APC mutation.  o If feasible, the specific APC mutation should be identified in
the affected first-degree relative with FAP prior to testing the member see (see below).
o “Full sequence” APC genetic testing is considered medically necessary only when the affected family member is unavailable or unwilling to be tested.
Note: First-degree relatives are parents, siblings, and offspring.
 APC genetic testing is considered investigational when the member has not met at least one of the criteria listed above.
MYH/MUTYH-Associated Polyposis (MAP) Genetic Testing may be considered medically necessary for ANY ONE of the following indications: * Personal history of 10 to 20 cumulative adenomatous polyps,
OR
with negative APC mutation testing and no family history of adenomatous polyposis




Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

General Guidelines for Lynch and FAP Syndromes

1. Testing may be done to distinguish between a diagnosis of Lynch syndrome versus Familial Adenomatous Polyposis (FAP). Whether testing begins with the “MLH1, MSH2, MSH6, PMS2” mutations or the “APC” mutations depends upon the clinical presentation. 

2. In ideal situations, initial genetic testing for FAP or Lynch syndrome is performed in an affected family member so that testing in unaffected family members can focus on the mutation found in the affected family member. When this was not done, the following guidelines apply.

Lynch-Specific Guidelines

1. For patients with colorectal cancer being evaluated for Lynch syndrome, it is recommended that either the microsatellite instability (MSI) test, or the immunohistochemistry (IHC) test,  with or without BRAF gene mutation testing, be used as an initial evaluation of tumor tissue prior to MLH1, MSH2, MSH6, PMS2 sequence analysis. (Note that MSI/IHC testing may not be feasible if no tumor tissue is available.) Consideration of proceeding to MLH1, MSH2, MSH6, PMS2 sequencing would depend on the results of MSI or IHC testing. IHC testing in particular may help direct which Lynch syndrome gene likely contains a mutation, if any, and may also provide some additional information if Lynch syndrome genetic testing is inconclusive.


2. Several Clinical Laboratory Improvement Amendments (CLIA)*licensed clinical laboratories offer gene mutation testing for Lynch syndrome. The GeneTests website (available online at: http://www.ncbi.nlm.nih.gov/sites/GeneTests/lab/clinical_disease_id/2622*db=genete sts) lists 21 U.S.-located laboratories that offer this service. Lynch syndrome mutation testing is packaged under a copyrighted name by at least one of these. The COLARIS® test from Myriad Genetic Laboratories includes sequence analysis of MLH1, MSH2, MSH6, and PMS2; large rearrangement analysis for MLH1, MSH2, PMS2, and MSH6 large deletions/ duplications; and analysis for large deletions in the EPCAM gene near MSH2. Two versions of this test, the COLARIS (excludes PMS2 testing) and COLARIS Update (includes PMS2 testing) are available. Testing is likely done in stages, beginning with the most common types of mutations. Individualized testing (e.g., targeted testing for a family mutation) can also be requested.

3. Amsterdam II clinical criteria are the most stringent criteria for defining families at high risk for Lynch syndrome. ALL of the following criteria must be fulfilled:

o 3 or more relatives have been diagnosed with an associated cancer (colorectal cancer, or cancer of the endometrium, small intestine, ureter or renal pelvis)
o 1 of the 3 should be a first-degree relative of the other 2
o 2 or more successive generations are affected
o 1 or more relatives were diagnosed before the age of 50 years
o Familial adenomatous polyposis (FAP) should be excluded in cases of colorectal carcinoma
o Tumors should be verified by pathologic examination
o Modifications:
* EITHER: very small families, which cannot be further expanded, can be considered to have HNPCC with only 2 colorectal cancers in first-degree relatives if at least 2 generations have the cancer and at least 1 case of colorectal cancer was diagnosed by the age of 55 years;
OR
* In families with 2 first-degree relatives affected by colorectal cancer, the presence of a third relative with an unusual early-onset neoplasm or endometrial cancer is sufficient.

4. The revised Bethesda guidelines are less strict than the Amsterdam criteria and are intended to increase the sensitivity of identifying at-risk families. The Bethesda guidelines are also felt to be more useful in identifying which patients with colorectal cancer should have their tumors tested for microsatellite instability and/or immunohistochemistry. Fulfillment of any of the following criterion meets guidelines:
o Colorectal carcinoma (CRC) diagnosed in a patient who is less than 50 years old
o Presence of synchronous (at the same time) or metachronous (at another time, i.e., a recurrence of) CRC or other Lynch syndrome*associated tumors, regardless of age
o CRC with high microsatellite instability histology diagnosed in a patient less than 60 years old
o CRC diagnosed in 1 or more first-degree relatives with a Lynch syndrome-associated tumor,( colorectal, endometrial, gastric, ovarian, pancreas, bladder, ureter and renal pelvis, brain (usually glioblastoma as seen in Turcot syndrome), and small intestinal cancers, as well as sebaceous gland adenomas and keratoacanthomas in Muir- Torre syndrome) with one of the cancers being diagnosed at younger than 50 years of age

o CRC diagnosed with 1 or more first-degree relatives with an HNPCC-related tumor (colorectal, endometrial, stomach, ovarian, pancreas, bladder, ureter and renal pelvis, biliary tract, brain [usually glioblastoma as seen in Turcot syndrome], sebaceous gland adenomas and keratoacanthomas in Muir-Torre syndrome, and carcinoma of the small bowel), with one of the cancers being diagnosed at younger than age 50 years, OR CRC diagnosed in 2 or more first- or second-degree relatives  with HNPCC-related tumor, regardless of age

Description

Genetic testing is available for both affected individuals and those at risk for various types of hereditary cancer. This review evaluates genetic testing for hereditary colorectal cancer and polyposis syndromes, including familial adenomatous polyposis, Lynch syndrome (formerly known as hereditary nonpolyposis colorectal cancer), MUTYH-associated polyposis, and Lynch syndrome*related endometrial cancer.


Background  Hereditary Colorectal Cancers

There are currently 2 well-defined types of hereditary colorectal cancer, familial adenomatous polyposis (FAP) and Lynch syndrome (formerly hereditary nonpolyposis colorectal cancer or HNPCC).

Familial Adenomatous Polyposis (FAP) and Associated Variants

FAP typically develops by age 16 years and can be identified by the appearance of hundreds to thousands of characteristic, precancerous colon polyps. If left untreated, all affected individuals will go on to develop colorectal cancer. The mean age of colon cancer diagnosis in untreated individuals is 39 years. FAP accounts for 1% of colorectal cancer and may also be associated with osteomas of the jaw, skull, and limbs; sebaceous cysts; and pigmented spots on the retina, referred to as congenital hypertrophy of the retinal pigment epithelium (CHRPE). FAP associated with these collective extra-intestinal manifestations is sometimes referred to as Gardner syndrome. FAP may also be associated with central nervous system (CNS) tumors, referred to as Turcot syndrome.

Germline mutations in the adenomatous polyposis coli (APC) gene, located on chromosome 5, are responsible for FAP and are inherited in an autosomal dominant manner. Mutations in the APC gene result in altered protein length in about 80% to 85% of cases of FAP. A specific APC gene mutation (I1307K) has been found in subjects of Ashkenazi Jewish descent that may explain a portion of the familial colorectal cancer occurring in this population. 

A subset of FAP patients may have attenuated FAP (AFAP), characterized by fewer than 100 cumulative colorectal adenomas occurring later in life than in classical FAP.
In AFAP, colorectal cancer occurs at an average age of 50-55 years, but there is a high lifetime risk of colorectal cancer of about 70% by age 80 years. The risk of extra-intestinal cancer is lower in AFAP compared to classical FAP, but it is still high at an estimated cumulative lifetime risk of 38% compared to the general population.

Only 30% or fewer of AFAP patients have APC mutations. Instead, some of these patients have mutations in the MUTYH (formerly MYH) gene and are then diagnosed with MUTYH-associated polyposis (MAP). MAP occurs with a frequency approximately equal to FAP, with some variability among prevalence estimates for both. While clinical features of MAP are similar to FAP or AFAP, a strong multigenerational family history of polyposis is absent. Bi-allelic MUTYH mutations are associated with a cumulative colorectal cancer risk of about 80% by age 70, whereas mono-allelic MUTYH mutation-associated risk of


colorectal cancer appears to be relatively minimal, although it is still under debate.

Thus, inheritance for high-risk colorectal cancer predisposition is autosomal recessive in contrast to FAP. When relatively few (i.e., between 10 and 99) adenomas are present and family history is unavailable, the differential diagnosis may include both MAP and Lynch syndrome. Genetic testing in this situation could include APC, MUTYH if APC is negative for mutations, and screening for mutations associated with Lynch syndrome.

It is important to distinguish among classical FAP, attenuated FAP, and MAP (mono- or bi-allelic) by genetic analysis because recommendations for patient surveillance and cancer prevention vary according to the syndrome

Lynch Syndrome

Patients with Lynch syndrome have a predisposition to colorectal cancer and other malignancies as a result of an inherited mutation in a DNA mismatch repair (MMR) gene. Lynch syndrome includes those with an existing cancer and those who have not yet developed cancer. The term “HNPCC” originated prior to the discovery of explanatory MMR mutations for many of these patients, and now includes some who are negative for MMR mutations and likely have mutations in as-yet unidentified genes.

For purposes of clarity and analysis, the use of Lynch syndrome in place of HNPCC has been recommended in several recent editorials and publications.

Lynch syndrome is estimated to account for 3% to 5% of colorectal cancer and is also associated with an increased risk of other cancers such as endometrial, ovarian, urinary tract, and biliary tract cancer. Lynch syndrome is associated with an increased risk of developing colorectal cancer by age 70. After correction for ascertainment bias, the risk is approximately 27% to 45% for men, and 22% to 38% for women.

Lynch syndrome patients who have colorectal cancer also have an estimated 16% risk of a second primary within 10 years.

Lynch syndrome is associated with any of a large number of possible mutations in 1 of several MMR genes, known as MLH1, MSH2, MSH6, PMS2, and rarely MLH3. Risk of all Lynch syndromerelated cancers is markedly lower for carriers of a mutation in the MSH6 and PMS2 genes, although for most cancers it is still significantly higher than that of the general population.

Coding   Code Description CPT

0028U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis (new code effective 1/1/18)

0029U Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823) (new code effective 1/1/18)

0031U CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7) (new code effective 1/1/18)

0069U Oncology (colorectal), microrna, rt-pcr expression profiling of mir-31-3p, formalin-

0070U fixed paraffin-embedded tissue, algorithm reported as an expression score
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN)
0071U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence (List separately in addition to code for primary procedure)

0072U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (List separately in addition to code for primary procedure)

0073U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (List separately in addition to code for primary procedure)

0074U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (List separately in addition to code for primary procedure)

0075U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5’ gene duplication/multiplication) (List separately in addition to code for primary procedure)

0076U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3’ gene duplication/ multiplication) (List separately in addition to code for primary procedure)

81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug


81226 CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6)

81230 CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22) (new code effective 1/1/18)

81231 CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *7) (new code effective 1/1/18)

81402 Molecular pathology procedure, Level 3 (eg, >10 SNPs, 2-10 methylated variants, or 210 somatic variants [typically using non-sequencing target variant analysis], immunoglobulin and T-cell receptor gene rearrangements, duplication/deletion variants of 1 exon, loss of heterozygosity [LOH], uniparental disomy [UPD]) includes:




Cytochrome P450 Genotype-Guided Treatment Strategy


Introduction

Metabolism is the term for how the body processes substances. Just as the body processes (metabolizes) foods, it also metabolizes medications. One gene in particular, cytochrome P450 (also called CYP450), is known to be involved in processing a large number of drugs. Certain changes, called mutations, may affect how well or poorly a drug is metabolized. Medical studies have shown that genetic testing for certain CYP450 gene mutations is helpful in determining how a person would metabolize some drugs. For example, drugs like clopidogrel for heart disease, eliglustat for Gaucher disease, and tetrabenazine for Huntington disease. However, reliable and large studies have not yet shown that this type of genetic testing is useful for other drugs. This policy describes when CYP450 genetic testing is covered.



Policy Coverage Criteria 

Test Medical Necessity
CYP450 genotyping (including CYP2C19 and CYP2D6 genes)

CYP450 genotyping for the CYP2C19 gene may be considered medically necessary for the following indication: * To aid in the choice of clopidogrel (Plavix®) versus alternative
anti-platelet agents OR * To determine optimal dosing for clopidogrel  CYP2D6 genotyping to determine drug metabolizer status may be considered medically necessary for the following indications: * Patient with Gaucher disease considering treatment with
eliglustat (Cerdelga™) OR * Patient with Huntington disease considering treatment with
tetrabenazine (Xenazine®) in a dosage greater than 50 mg per day
Test Investigational
CYP450 genotyping (including CYP2C19 and CYP2D6 genes)

CYP450 genotyping (including CYP2C19 and CYP2D6 genes)to determine drug choice or dose for all other drugs not listed in the Medical Necessity section above is considered investigational, unless noted otherwise in a  separate policy (see Related Medical Policies).  The use of genetic testing panels that include multiple CYP450 variants/mutations/polymorphisms is considered investigational. 
Note: Multigene testing panels that include CYP450 and other non CYP450 genes are addressed in other policies. (See Related Medical Policies) This policy only addresses individual genetic tests for CYP450 (including CYP2C19, and CYP2D6 genes).


Related Information 

Definition of Terms
Cytochrome P450: This refers to a family of 60 different enzymes involved in drug and toxin metabolism.
Genotype testing: This is a type of testing used to determine the DNA sequence in genes.
Metabolize: This is a term that refers to breaking down a molecule into smaller units. If a drug is metabolized, it is no longer clinically active.
Polymorphisms: This is a genetic variation between individuals resulting in differences in form or gene expression, in this case differing activity of various enzymes.

Genetics Nomenclature Update 

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.
The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology*“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”*to describe variants identified that cause Mendelian disorders.


Previous  Updated  Definition

variant
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.


Description

The cytochrome P450 (CYP450) family is involved in the metabolism of many currently administered drugs, and genetic variants in cytochrome P450 are associated with altered metabolism of many drugs. Testing for cytochrome P450 variants may assist in selecting and dosing drugs affected by these genetic variants.

Background  Drug Efficacy and Toxicity 

Drug efficacy and toxicity vary substantially between individuals. Because drugs and doses are typically adjusted, if needed, by trial-and-error, clinical consequences may include a prolonged time to optimal therapy. In some cases, serious adverse events may result.
Multiple factors may influence the variability of drug effects, including age, liver function, concomitant diseases, nutrition, smoking, and drug-drug interactions.
Inherited (germline) DNA sequence variation in genes coding for drug-metabolizing enzymes, drug receptors, drug transporters, and molecules involved in signal transduction pathways also may have major effects on the activity of those molecules and thus on the efficacy or toxicity of a drug.

Pharmacogenomics studies how an individual’s genetic inheritance affects the body’s response to drugs. It may be possible to predict therapeutic failures or severe adverse drug reactions in individual patients by testing for important DNA variants (genotyping) in genes related to the metabolic pathway (pharmacokinetics) or signal transduction pathway (pharmacodynamics) of the drug. Potentially, test results could be used to optimize drug choice and/or dose for more effective therapy, avoid serious adverse events, and decrease medical costs.

Cytochrome P450 System

The cytochrome P450 (CYP450) family is a major subset of all drug-metabolizing enzymes; several CYP450 enzymes are involved in the metabolism of a significant proportion of currently administered drugs. CYP2D6 metabolizes approximately 25% of all clinically used medications (eg, dextromethorphan, ß-blockers, antiarrhythmics, antidepressants, morphine derivatives), including most prescribed drugs. CYP2C19 metabolizes several important types of drugs, including proton pump inhibitors, diazepam, propranolol, imipramine, amitriptyline, and clopidogrel.

Some CYP450 enzymes are highly polymorphic, resulting in some enzyme variants that have variable metabolic capacities among individuals, and some with little to no impact on activity. Thus, CYP450 enzymes constitute an important group of drug-gene interactions influencing the variability of the effect of some CYP450-metabolized drugs.

Individuals with 2 copies (alleles) of the most common (wild-type) DNA sequence of a particular CYP450 enzyme gene resulting in an active molecule are termed extensive metabolizers (EMs; normal). Poor metabolizers (PMs) lack active enzyme gene alleles, and intermediate metabolizers, who have 1 active and 1 inactive enzyme gene allele, may experience to a lesser degree some of the consequences of PMs. Ultrarapid metabolizers (UMs) are individuals with more than 2 alleles of an active enzyme gene. There is pronounced ethnic variability in the population distribution of metabolizer types for a given CYP enzyme.

UMs administered an active drug may not reach therapeutic concentrations at usual recommended doses of active drugs, while PMs may suffer more adverse events at usual doses due to reduced metabolism and increased concentrations. Conversely, for administered prodrugs that must be converted by CYP450 enzymes into active metabolites, UMs may suffer adverse events, and PMs may not respond.

Many drugs are metabolized to varying degrees by more than 1 enzyme, either within or outside of the CYP450 superfamily. Also, the interaction between different metabolizing genes, the interaction between genes and environment, and interactions among different nongenetic factors also influence CYP450-specific metabolizing functions. Thus, identification of a variant in a single gene in the metabolic pathway may be insufficient in all but a small proportion of drugs to explain interindividual differences in metabolism and consequent efficacy or toxicity.

Determining Genetic Variability In Drug Response

Genetically determined variability in drug response has been traditionally addressed using a trial-and-error approach to prescribing and dosing, along with therapeutic drug monitoring for drugs with a very narrow therapeutic range and/or potentially serious adverse events outside that range. However, therapeutic drug monitoring is not available for all drugs of interest, and a cautious trial-and-error approach can lengthen the time to achieving an effective dose.

CYP450 enzyme phenotyping (identifying metabolizer status) can be accomplished by administering a test enzyme substrate to a patient and monitoring parent substrate and metabolite concentrations over time (eg, in urine). However, testing and interpretation are timeconsuming and inconvenient; as a result, phenotyping is seldom performed.


The clinical utility of CYP450 genotyping (ie, the likelihood that genotyping will significantly improve drug choice, dosing, and patient outcomes) may be favored when the drug under consideration has a narrow therapeutic dose range, when the consequences of treatment failure are severe, and/or when serious adverse reactions are more likely in patients with gene sequence variants. Under these circumstances, genotyping may direct early selection of the most effective drug or dose, and/or avoid drugs or doses likely to cause toxicity. For example, warfarin, some neuroleptics, and tricyclic antidepressants have narrow therapeutic windows and can cause serious adverse events when concentrations exceed certain limits, resulting in cautious dosing protocols. The potential severity of the disease condition may call for immediate and sufficient therapy; genotyping might speed up the process of achieving a therapeutic dose and avoiding significant adverse events.FDA has required the package insert for clopidogrel carry a black box warning concerning possible worse outcomes with clopidogrel treatment in patients with genetic variants. The FDA warning suggests changes in doses or changes in drug.

2019 CPT codes offer payment for Digital Medicine

Reflecting the reality that physicians and their staff spend an increasing amount of time engaging with technology to enhance and improve patient care, the 2019 Current Procedural Terminology (CPT®) code set that takes effect Jan. 1 provides health professionals the codes they need to get paid for emerging services.

Among the changes in the 2019 CPT code set are three new remote patient monitoring codes that reflect how health professionals can more effectively and efficiently use technology to connect with their patients at home to gather data for care management and coordination. Specifically:

99453 - Remote monitoring of physiologic parameter(s), (for example, weight, blood pressure, pulse oximetry, respiratory flow rate) initial; setup and patient education on equipment use.

99454 - Device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.

99457 - Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.

There also are two new interprofessional internet consultation codes to reflect the increasing importance of using non-verbal communication technology to coordinate patient care between a consulting physician and treating physician. Specifically:

99451 - Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician, including a written report to the patient’s treating/requesting physician or other qualified health care professional, 5 minutes or more of medical consultative time.

99452 - Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or other qualified health care professional, 30 minutes.

Medicare’s acceptance of the new codes would signal a landmark shift to better support physicians participating in patient population health and care coordination services that can be a significant part of a digital solution for improving the overall quality of medical care.


ADDITIONAL COVERAGE REQUIREMENTS FOR THE USE OF THESE CPT CODES INCLUDE:

• Advance patient consent: practitioners must obtain advanced consent for the service and document in the patient’s record.

• 30-day reporting period: billing limited to once in a 30-day period.

• Use with other services: billing is permitted for the same service period as chronic care management (CCM) (CPT  codes 99487-99490), transitional care management (TCM) (CPT codes 99495-99496), and behavioral health integration  (BHI) (CPT codes 99484, 99492-99494).

• The Medicare program will be issuing additional guidance on the type of remote patient monitoring technology that  will be permitted under 99454.

• CPT code 99457 and 99091 may not be billed together for same billing period and beneficiary.



Interprofessional Telephone/Internet Consultations - Uhc Guidelines

UnitedHealthcare follows CMS guidelines effective for services rendered on or after January 1, 2019, which  considers interprofessional telephone/Internet assessment and management services reported with CPT codes 99446 - 99449  and  99451 - 99452 eligible for reimbursement
according to the CMS Physician Fee Schedule (PFS).

Digitally Stored Data Services/Remote Physiologic Monitoring

UnitedHealthcare follows CMS guidelines effective for services rendered on or after January 1, 2019, which  considers digitally stored data services or remote physiologic monitoring services reported with CPT codes 99453, 99454, 99457 ,  and 99091  eligible fo r reimbursement accord ing to the CMS Physician Fee Schedule (PFS).


Modernizing Medicare Physician Payment by Recognizing Communication Technology Based Services


CMS is finalizing its  proposals to pay separately for two newly defined physicians’ services  furnished using communication technology:

• Brief commu nication technology -based service, for example,  virtual check -in  (Healthcare Common Procedure  Coding System (HCPCS) code G2012)

• Remote evaluation of recorded video and/or images submitted by an established patient  (HCPCS code G2010) 

CMS is also finalizing policies to pay separately for new coding describing chronic care remote  physiologic monitoring (Current Procedural Terminology  ( CPT )  codes 99453, 99454, and MLN Matters  99457) and interprofessional internet consultation (CPT codes 99451, 99452, 99446, 99447,  99448 , and 99449).




CY2019 PFS: CPT 99446, 99447, 99449, 99451, 99452

• Interprofessional internet consultation (telephone/internet/electronic health  record)


– CPT 99451  - Assessment and management service provided by a  consultative physician  (WRVU 0.70)

• 5 or more minutes of medical consultative time


–
CPT 99452  - Referral service(s) provided by a treating/requesting  physician or qualified health care professional  (WRVU 0.70)
• 30 minutes
• Includes a verbal and written report to the patient's treating/requesting physician or other qualified health care professional
• Billing limited to practitioners that can independently bill Medicare for E/M  services

Code Description CPT 

81223 CFTR (cystic fibrosis transmembrane conductance regulator) (e.g., cystic fibrosis) gene analysis; full gene sequence

81257 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis, for common deletions or variant (eg, Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2, alpha20.5, and Constant Spring) (effective 1/1/18)

81258 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; known familial variant (effective 1/1/18)

81259 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; full gene sequence (effective 1/1/18)

81269 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; duplication/deletion variants (effective 1/1/18)

81412 Ashkenazi Jewish associated disorders (eg, Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at least 9 genes, including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, and SMPD1

81479 Unlisted molecular pathology procedure


What are MoPath Codes?

MoPath codes are labels for molecular diagnostics tests that enable payers (i.e., Medicare, Medicaid, private insurance companies) to properly identify and bill for services. In 2012, the AMA CPT estab-lished a new set of analyte-specific MoPath codes to replace the methodology-based codes (CPT 83890-83914; 88384-88386) that previously allowed labs to bill different coding combinations (also known as “code stacks”) for tests evaluating the same analyte. These “stacking” codes were retired as of January 1, 2013. Labs are now required to report tests using the analyte-specific  MoPath codes.

The MoPath codes are categorized into Tier 1 and Tier 2 codes:

•  Tier 1 codes represent the majority of commonly performed single-analyte molecular tests.

•  Tier 2  codes represent procedures that are generally performed in  lower volumes than Tier 1 procedures (e.g., when the incidence of  the disease being tested is rare), and correspond to nine ascending levels of technical resources and interpretive work performed by the  physician or other qualified healthcare professional


Coverage

In general, CF genetic testing is widely covered for both carrier  screening and confirmatory diagnostic testing (Figures 1 and 2). Private payers generally separate coverage guidelines for CF carrier screening versus confirmatory diagnostic testing. For both indica-tions, the majority of payers have either issued positive coverage policies or no policies at all. The absence of a coverage policy does not necessarily indicate non-coverage, but implies that the procedure may be covered if medical necessity can be justified.


Based on private payer coverage guidelines, CF carrier screening is generally covered for individuals who meet any of the following criteria:

• Couples seeking prenatal care

•  Couples who are planning a pregnancy

•  Persons with a family history of CF

•  Persons with a 1st degree relative identified as a CF carrier

•  Reproductive partners of persons with CF Additionally, CF diagnostic testing is typically covered for individuals

who meet any of the following criteria:

• Individual who exhibits symptoms of CF but has a negative sweat test

• Infant with meconium ileus or other symptoms indicative of CF who is too young to produce inadequate volumes of sweat for a sweat chloride test 

•  Male infertility from either of the following:

- Congenital bilateral absence of vas deferens (CBAVD)

- Azoospermia or severe oligospermia  (i.e., < 5 million sperm/milliliter) with palpable vas deferens The majority of state Medicaid agencies do not have policies specifi-cally addressing coverage for CF genetic testing (carrier screening  or diagnostic testing), but instead have general coverage policies for  laboratory services performed by CLIA-approved labs.


Payment
For 2013, the Centers for Medicare & Medicaid Services (CMS) assigned the local Medicare Administrative Contractors (MACs) the responsibility of setting regional fee schedule amounts for the new MoPath code set (including payment rates for CF testing) via gapfilling.Gapfilling is used when a comparable test does not exist. CMS instructs local MACs to establish payment rates in the first year based on charges and routine discounts to charges, resources required, and other payers’ payment rates. For reimbursement in the second year and beyond, CMS calculates a national payment rate by using the median of the local MAC fee schedules.On September 30, 2013, CMS released the 2014 national Medicare fee schedule amounts for the MoPath codes, which were based on the final gapfill rates determined by each MAC

.  However, the national fee schedule did not include any payment rates for the cystic fibrosis testing codes. Since payment rates will vary by payer (both private and public), laboratories are encouraged to contact individual payers directly to clarify the fee schedule amounts for these codes in 2014.


Preconception Screening for Carrier Status of Genetic Diseases

Introduction

Genetic tests are laboratory tests that measure changes in human DNA, chromosomes, genes or gene products (proteins). Blood, skin, cheek swabs, and amniotic fluid are some common samples that can be tested. Genetic testing for carrier status is done on people planning a pregnancy. The goal is to see if they have a potential disease that could be passed on to their offspring. For certain disorders, a carrier state can exist where a person has no symptoms of the disease, but has the potential to pass the disease on to their children because they carry a gene for the disease. Often it takes at least two copies of the gene for the disease to cause symptoms. Usually carrier testing is done before conception when individuals are planning a pregnancy, but it may also be done in the early stages of pregnancy.



Policy Coverage Criteria 

This policy applies only if there is not a separate policy that outlines specific criteria for carrier testing. If a separate policy exists, then criteria for medical necessity in that policy supersedes the guidelines in this policy (see Related Policies).
Note: Usually carrier testing is done before conception when individuals are planning a pregnancy, but it may also be done in the early stages of pregnancy.
Test Type Medical Necessity Expanded Carrier

Expanded Carrier Screening Panels

Expanded carrier screening panels which test for mutations on many different genes are considered not medically necessary. Based on the individual tested, a subset of tests within the panel may be covered when the policy criteria are met.

The names of expanded carrier panels, and their individual mutation components, are rapidly evolving. Examples of panels addressed in this policy include but are not limited to: * Counsyl™ (Counsyl) * GoodStart Select™ (GoodStart Genetics) * Inherigen™ (GenPath) * InheriGen Plus * Inheritest™ (LabCorp) * Natera One™ Disease Panel (Natera)  Genetic Disease Medical Necessity The General Population  Cystic fibrosis (CPT 81220) Covered for all individuals with a panel that tests the most common genes 

Note: Carrier testing for cystic fibrosis using CPT 81223 “CFTR (eg, cystic fibrosis) gene analysis; full gene sequence” is considered not medically necessary for carrier testing.


Genetic Disease Medical Necessity  Spinal muscular atrophy (CPT 81400, 81401)

Covered for all individuals

Genetic Disease Medical Necessity Specific Groups or Populations

The following genetic testing may also be considered medically necessary due to an increased frequency of certain disorders in groups or populations
Ashkenazi Jewish founder mutations:

* Bloom syndrome  * Canavan disease  * Cystic fibrosis  * Familial dysautonomia  * Fanconi anemia (group C)  * Gaucher disease * Mucolipidosis IV  * Niemann-Pick (type A)

* Tay-Sachs disease

FMR1 variants (including Fragile-X syndrome)

Ashkenazi Jewish founder mutations may be considered medically necessary when the individual meets one of the following criteria: * Ashkenazi Jewish ancestry consisting of a minimum of one
Jewish grandparent * If the Jewish partner has a positive carrier test result, the other
partner (regardless of ethnic background) should be screened only for that identified mutation

Genetic testing for Ashkenazi Jewish founder mutation is considered not medically necessary for all other uses.

Genetic testing for FMR1 variants may be considered medically necessary when any of the following criteria are met: * Parent of either sex with intellectual disability, developmental delay, or autism spectrum disorder * Parent with a family history of fragile X syndrome or a family  history of undiagnosed intellectual disability  * Prenatal testing of fetuses of mothers  who are known carriers   to determine whether the fetus inherited the normal or mutant FMR1 gene

* Affected individuals or first- and second- degree relatives   of affected individuals who have had a positive cytogenetic fragile X test (less accurate historic test) result who are seeking further counseling related to the risk of carrier status

Genetic testing for FMR1 variants (including Fragile-X syndrome) is considered not medically necessary for all other

Genetic Disease Medical Necessity  uses.  Alpha-thalassemia

preconception (carrier) testing

Preconception (carrier) testing for alpha-thalassemia in prospective parents may be considered medically necessary when all of the following criteria are met: * At least one parent is of a high-risk ethnic group, such as
Southeast Asian, African or Mediterranean ancestry * At least one parent has had abnormal biochemical testing
which may include ANY of the following: o Anemia o Microcytosis (a low MCV – small blood cells) o Hypochromia (a low MCH or MCHC – red blood cells with
less hemoglobin) o Abnormal hemoglobin electrophoresis

Genetic testing for hemoglobinopathies, except for alphathalassemia, is considered not medically necessary.
Genetic Disease Medical Necessity Other Inherited Disorders

Carrier testing of specific disorder

May be considered medically necessary when ONE of the following criteria are present: * One or both parents have a first-  or second-degree relative*
who has the disorder * One parent is or both parents are a known carrier of the
disorder. 

Note: 1st-degree relatives are parents, siblings, and children. 2nd-degree relatives are grandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings. 

AND all of the following criteria must also be met: * The natural history of the disease is understood and the
disease is likely to result in severe health problems * Other biochemical or clinical tests to diagnose carrier status are


Genetic Disease Medical Necessity Coding not available, or are less accurate than genetic testing * The genetic test has adequate sensitivity and specificity to guide clinical decision making  o The American College of Medical Genetics and Genomics (ACMG) recommends testing for specific mutations, which will result in carrier detection rate of 95% or higher for most disorders.

* A clear association of the genetic change with the disorder has been established Genetic testing for other specific disorders is considered not medically necessary when the criteria above are not met.




Related Information 

If there is no family history of, risk based or ethnic predilection for a disease, carrier screening is not recommended when the carrier rate is less than 1% in the general population.

ACMG has defined expanded panels as those that use next-generation sequencing to screen for variants in many genes, as opposed to gene-by-gene screening (eg, ethnic-specific screening or pan-ethnic testing for cystic fibrosis).
Expanded panels may include the diseases that are present with increased frequency in specific populations, but typically include testing for a wide range of diseases for which the patient is not at risk of being a carrier.
Carrier screening should only be performed in adults. 

For individuals who are at risk due to an established family history of fragile X syndrome, DNA testing alone is sufficient. If the diagnosis of the affected relative was based on previous cytogenetic testing for fragile X syndrome, at least one affected relative should have DNA testing.
Prenatal testing of a fetus should be offered when the mother is a known carrier to determine whether the fetus inherited the normal or mutant FMR1 gene. Ideally DNA testing should be performed on cultured amniocytes obtained by amniocentesis after 15 weeks’ gestation. DNA testing can be performed on chorionic villi obtained by chorionic villus sampling at 10 to 12 weeks’ gestation, but results must be interpreted with caution because the methylation status of the FMR1 gene is often not yet established in chorionic villi at the time of sampling. follow-up amniocentesis may be necessary to resolve an ambiguous result.


Definition of Terms


1st-, 2nd-, or 3rd-degree relative: For the purpose of familial assessment, 1st-, 2nd-, or 3rddegree relatives are blood relatives on the same side of the family (maternal or paternal). The maternal and paternal sides of the family should be considered independently for familial patterns of inherited disorders. 

* 1st-degree relatives are parents, siblings, and children.
* 2nd-degree relatives are grandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings.
* 3rd-degree relatives are great-grandparents, great-aunts, great-uncles, great-grandchildren, and first cousins 
Carrier testing: Carrier genetic testing is performed on people who display no symptoms for a genetic disorder but may be at risk for passing it on to their children.
A carrier of a genetic disorder has one abnormal allele for a disorder.  Carriers of an autosomal recessive mutation are typically unaffected.  Offspring who inherit the mutation from both parents usually manifest the disorder. When associated with an autosomal dominant or an Xlinked dominant disorder, the individual may be affected with the disorder or be at high risk of developing the disorder later in life. Women with an X-linked recessive mutation are usually unaffected. Males receiving a chromosome with an X-linked recessive mutation usually manifest the disorder.
Compound heterozygous: The presence of two different mutant alleles at a particular gene locus, one on each chromosome of a pair.

Expressivity/expression: The degree to which a penetrant gene is expressed within an individual.
Genetic testing: A test that analyzes chromosomes, DNA, RNA, genes, or gene products to detect inherited (germline) or non-inherited (somatic) genetic variants related to disease or health

Homozygous: Having the same alleles at a particular gene locus on homologous chromosomes (chromosome pairs).
Penetrance: The proportion of individuals with a mutation that causes a particular disorder who exhibit clinical symptoms of that disorder.

Residual risk: The risk that an individual is a carrier of a particular disease, but genetic testing for carrier status of the disease is negative (eg, if the individual has a disease-causing mutation that wasn’t included in the test assay).

Testing sequence: Testing sequence of carrier testing for genetic diseases is generally done on the mother or affected partner first, and if positive, then the other parent is tested.

Genetics Nomenclature Update

Human Genome Variation Society (HGVS) nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). HGVS nomenclature is recommended by HGVS, the Human Variome Project, and the HUman Genome Organization (HUGO).

The American College of Medical Genetics and Genomics (ACMG) and Association for Molecular Pathology (AMP) standards and guidelines for interpretation of sequence variants represent expert opinion from ACMG, AMP, and the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA
Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence

Variant Classification Definition 

Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology. providing a diagnosis eliminates the need for further diagnostic workup. A chain of evidence supports improved outcomes following FMR1 variant testing.. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have a personal or family history of FXS who are seeking reproductive counseling, the evidence includes studies  evaluating the clinical validity of FMR1 variant testing and the effect on reproductive decision making. Testing the repeat region of the FMR1 gene in the context of reproductive decision making may include individuals with either a family history of FXS or a family history of undiagnosed intellectual disability, fetuses of known carrier mothers, or affected individuals or their relatives who have had a positive cytogenetic fragile X test result who are seeking further counseling related to the risk of carrier status among themselves or their relatives. DNA testing would accurately identify premutation carriers and distinguish premutation from full mutation carrier women. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Procedure Code(s) and Description

76705 Ultrasound, abdominal, real time with image documentation; limited (eg, single organ, quadrant,  follow-up)

76706  Ultrasound Screening Study for Abdominal Aortic Aneurysm


Preventive Benefit Instructions

Age 65 through 75 (ends on 76thbirthday). Requires at least one of the diagnosis codes listed in this row

Diagnosis Code(s)- covered ICD 10 codes

F17.210, F17.211, F17.213, F17.218, F17.219, Z87.891


Medicare guidelines for using AAA screen


Effective for services furnished on or after January 1, 2017, the following code and modifiers, are used for AAA screening services:76706: Ultrasound, abdominal aorta, real time with image documentation, screening study for abdominal aortic aneurysm (AAA). (For screening ultrasound or duplex ultrasound of the abdominal aorta other than screening, see 76770, 76775, 93978, 93979.)

Short Descriptor:  Us abdl aorta screen AAA

Modifiers:  TC, 26


Fee amount for technical and professional component

CPT 76705
Professional $30.24
Technical $63.72
Global$93.96


CPT 76706
Professional $28.44
Technical$68.40
Global$96.84


Documentation Requirements

Ultrasound performed using either a compact portable  ultrasound or a console ultrasound system are reported  using the same CPT codes as long as the studies that were  performed meet all the following requirements:

• Medical necessity as determined by the payer
• Completeness
• Documented in the patient’s medical record

A separate written record of the diagnostic ultrasound  or ultrasound-guided procedure must be completed and  maintained in the patient record.7 This should include a  description of the structures or organs examined and the  findings and reason for the ultrasound procedure(s).  Diagnostic ultrasound procedures require the production and retention of image documentation. It is recommended that permanent ultrasound images, either electronic or hardcopy, from all ultrasound services be retained in the patient record  or other appropriate archive.


Coverage

Use of ultrasound-guided procedures may be a covered benefit if such usage meets all requirements established by the particular payer. In many cases, because the use of ultrasound guidance is an emerging technology, it may be considered investigational and may not be a covered procedure.It is advisable that you check with your local Medicare Contractor. Also, it is essential that each claim be coded appropriately and supported with adequate documentation in the medical record.

Coverage by private payers varies by payer and by plan with respect to which medical specialties may perform ultrasound services. Some payers will reimburse ultrasound procedures to all specialties while other plans will limit reimbursement for ultrasound procedures to specific types of medical specialties.


In addition, there are plans that require providers to submit applications requesting these services be added to the list of services performed in their practice. It is important that you contact the payer prior to submitting claims to determine their requirements

CPT code and Description

H0001 Alcohol and/or drug assessment
H0004 Behavioral health counseling and therapy (15 min)
H0002 Behavioral health screening to determine eligibility for admission to treatment program 
H0005 Alcohol and/or drug services; group counseling by a clinician
H0046 Mental Health Services, Not Otherwise Specified (60 Min)
H0047 Alcohol and/or other drug abuse services, not otherwise specified


Billing Guidelines

CPT H0046- Direct communications with the client and/or collaterals designed to help an enrolled individual attain goals as prescribed in his/her individual service plan. Usage is limited to medically necessary contacts less than 10 minutes that cannot otherwise be reported elsewhere. (Excludes: reminder (non-therapeutic) phone calls, listening to voice mails, e-mails)

For example, a clinician providing a half-hour of individual psychotherapy may code the service as 90832 (Psychotherapy, 30 min with patient and/or family member). If, however, the client leaves after 10 minutes, coding 90832 for that service would not meet fidelity for that code. It would not only be difficult to contend that insight-oriented, behavior modifying or supportive psychotherapy had been provided during such a short time, and CPT guidelines specifically require a minimum of 16 minutes for the use of this code. The service could be coded and reported using H0046, “Mental Health Services Not Otherwise Specified,” which can be reported in minutes. See Individual Treatment services modality for H0046 usage limitations.

CPT H0047 - Direct communications with the client and/or collaterals designed to help an enrolled individual attain goals as prescribed in his/her individual service plan. (Excludes: reminder (non-therapeutic) phone calls, listening to voice mails, e-mails) For Medicaid funded services, this service may only be provided by a CDP or CDPT.

If H0046 (Mental health services, not otherwise specified) is provided for 9 minutes, report 9 minutes.

If H0047 (Alcohol and/or other drug abuse services, not otherwise specified) is provided for 7 minutes, report 7 minutes.

CPT H0001 - Must be doneface-to-face. Provider type - 20-Chemical Dependency Professional  21-Chemical Dependency Professional Trainee

CPT H004 - 10 Minutes minimumfor first unit - Provider type - 20-Chemical Dependency Professional  21-Chemical Dependency Professional Trainee. 01-RN/LPN  02-ARNP/PA   03-Psychiatrist/MD   04-MA/Ph.D.   05-Below Masters Degree  09-Bachelors Level w/Exception Waiver   10-Master Level w/Exception Waiver.



Reimbursement Guidelines from UHC insurance


Documentation maybe reviewed for appropriate coding, existence of a more appropriate code, coverage, reimbursement allowance and prior notification if needed. Unlisted codes that do not have documentation will be denied.

Texas 

Documentation and review not needed for:
** 99429,State requires providers to bill unlisted code 99429 whenproviding dental varnish
** A4335 when billed with an U9 modifier
** H0046when billed by an FQHC for Texas MMP
** H0046 when billed for Texas Chip, Star Kidsand Star Plus** B9998 when billed with modifiers U1-U5



SUBSTANCE ABUSE PROCEDURE CODES

H0001  Alcohol  and/or  drug  assessment  – means  the  evaluation  of  an  individual  by  a clinician to determine the presence, nature, and extent of substance use disorder with the goal of formulating a plan for services (if such services are offered) and treating the client in the most appropriate treatment environment.

H0003 Alcohol and/or drug screening; laboratory analysis of specimens for presence of alcohol and/or drugs – means the laboratory testing of client specimens to detect the presence of alcohol and other drugs.

H0005  Alcohol  and/or  drug  services;  group  counseling  by  a  clinician –  means services   provided   by   a   clinician   to   assist two or more individuals and/or their families/significant  others  to  achieve  treatment  objectives  through  the  exploration  of substance use disorders and their ramifications, including an examination of attitudes and feelings, and considering alternative solutions and decision making with regard to alcohol and other drug related problems.

H0006 Alcohol and/or drug services; case management – means services provided to link individuals to, or to assist and support clients in gaining access to or to develop their skills  for  gaining  access  to  needed  medical,  social,  educational  and  other  services essential to meeting basic human needs, as appropriate; to train the individual in the use of  basic  community  services;  and  to  monitor  treatment  progress  and  overall  service delivery. 

H0007 Alcohol and/or drug services; crisis intervention (outpatient) – means a face-to-face response to a crisis or emergency situation experienced by an individual, family member and/or significant others related to substance use disorders.

H0008 Alcohol and/or drug services; sub-acute detoxification (hospital inpatient) –  means face-to-face interactions with an individual for the purpose of medically managing and  monitoring  withdrawal  symptoms  from  alcohol  and/or  drug  addiction  in  a  hospital with appropriate accreditation, certification, and licensure, staffed with a registered nurse on  the  premises  twenty-four  hours  per  day  and  a  licensed  physician  on  call  twenty-four hours per day. Detoxification services must be supervised by a licensed physician. 



Q:Will UnitedHealthcare reimburse more than one presumptive and/or one definitive drug test on the same date of service if a modifier is appended?
A:No, each of the presumptive and definitive drug codes define a single manual or automated laboratory service that is reported once per day, per patient,irrespective of the number of Drug Classes, sample validations, or Specimen Validity Testsperformed related to that service on any date of service. In accordance with the CPT and CMS guidelines UnitedHealthcare will not reimburse more than one presumptive and/or one definitive drug test per dayregardless of the number of billing providers.


Presumptive Codes

H0003  Alcohol and/or drug screening; laboratory analysis of specimens for presence of alcohol and/or drugs(The H  codes are used by those state Medicaid agencies that are mandated by state law to establish separate codes for identifying mental health services that include alcohol and drug treatment services.)



Prenatal and Postnatal Psychosocial Counseling  

Psychosocial evaluation is provided as a prenatal and postnatal service to identify members and families with high psychological and social risks, to develop a psychosocial care plan and provide or coordinate appropriate intervention, counseling or referral necessary to meet the identified needs of each family.  
Counseling may be provided by one of the following licensed Medicaid providers:

**   Licensed Clinical Social Worker
**   Clinical Psychologist
**   Marriage and Family Therapist

The service is reported using HCPCS H0046 Mental Health Services, Not Otherwise Specified.  Limited to twelve (12) visits during any 12-month period. 

CPT CODE and Description

H1000  PRENATAL CARE, AT-RISK ASSESSMENT
H1001 Prenatal care, at-risk enhanced service; antepartum management
H1003 Prenatal care, at-risk enhanced service; education



HCPCS Code  H1000 - Prenatal care atriskassessm


Risk Assessment 

Risk assessment is the systematic review of relevant member data to identify potential problems and determine a plan for care.  Early identification of high risk pregnancies with appropriate consultation and intervention contributes significantly to an improved perinatal outcome and lowering of maternal and infant morbidity and mortality.   A care plan for high risk members, in addition to standard care, includes referral to or consultation with an appropriate specialist, individualized counseling and services designed to address the risk factor(s) involved.  A care plan for low risk members includes primary care services and additional services specific to the needs of the individual.  

Risk Assessments may be provided by one of the following licensed Medicaid providers:

**   Physician
**   Certified Nurse Practitioner
**   Certified Nurse-Midwife

The service is reported using HCPCS H1000 Prenatal Care, At Risk Assessment for a low risk assessment or HCPCS H1001 Prenatal Care, At Risk Enhances Service; Antepartum Management for high risk assessment.  Limited to two (2) assessments during any 10-month period.

Single Prenatal Visit(s) Other than Initial Visit

A single prenatal visit other than the initial visit is a single prenatal visit for an established member who does not return to complete care for unknown reasons.  The initial assessment visit was completed, a plan of care established, one or two follow-up visits completed, without further care provided.

Single Prenatal Visit may be provided by one of the following licensed Medicaid providers:

**   Physician
**   Certified Nurse Practitioner
**   Certified Nurse-Midwife 

The service is reported using an appropriate CPT E/M code.  Limited to three (3) visits in any 10-month period.  The service may be billed only when the member is lost to follow up for any reason.  


Prenatal Assessment Visit (Initial Visit Only)

The initial prenatal assessment visit is a single prenatal visit for a new patient with a confirmed pregnancy, providing an evaluation of the mental and physical status of the patient, an in depth family and medical history, physical examination, development of the medical data and initiation of a plan of care.  
Prenatal Assessment Visit may be provided by one of the following licensed Medicaid providers:

**   Physician
**   Certified Nurse Practitioner
**   Certified Nurse-Midwife 

The service is reported using an appropriate CPT E/M code.  Limited to one (1) visit in any 10-month period, to be used only when the patient is referred immediately to a community practitioner because of identified risks or otherwise lost to follow-up because the patient does not return. 

Billing Guidelines from Uhc

Florida
** Prenatal care must be billed separately from the delivery and postpartum care.
** FL providers are to submit prenatal codes H1001 and/or H1000.
** Up to 10 visits are allowed for prenatal care.** Up to two postpartum visits are allowed within 90 days following delivery, per recipient.
** Delivery of two or more infants from a single pregnancy, by different delivery method, separately.  Same delivery method is non-covered


BCBS insurance Guidelines

Pre-term Birth Prevention Services

Blue Cross will reimburse for certain pre-term birth prevention serviceswhen the patient’s contract covers these services.

CODE                     NARRATIVE               BILLING
H1001       Prenatal care, at-risk enhancedservice; antepartum management        If the patient isidentified via the assessment as high risk. This code may be billed once.

H1003       Prenatal care, at-risk enhanced                            If the patient isidentified via the assessment as high risk. This code may be billed once.




The services represented by the prenatal care at-risk codes H1002, H1004 and H1005 are already included in the provider’s normal prenatal care and not separately reimbursed.



All Prenatal visits must be billed using the appropriate E&M code for each prenatal visit.  Specific CPT and  HCPCS  Codes  are  listed.   MFC  has  included  a  list  of  CPT  Codes  provided  by  MDH.   This  list  is subject to change at any time without notice when MDH updates their On-Line information.

** Delivery services can be billed 1 of 2 ways: o Delivery Service + Post Partum Care o Delivery Services Only

** Providers may bill: o H1000 (Risk Assessment) once per pregnancy o H1003  (Enhanced  Services)  once  per  visit  for  Maryland  Medicaid  members.   Providers  must document in the medical record that health education and counseling appropriate to the needs of the pregnant woman was provided.

** OBs must bill for circumcisions under the infant’s own name and Medicaid Number /MFC Number.** For procedure codes with a global value MMM, the global period equals 56 days.

** When a provider bills a delivery + post partum care at the time of delivery, the provider must rebill using the exact same codes when the post partum visit actually takes place and adding the modifier TH to the claim.  Use of this modifier however will indicate he date that the postpartum visit actually occurred.  The postpartum visit has to occur on or between 21 and 56 days after delivery. ** If the provider bills the delivery only code, and then later bills the delivery + postpartum code to indicate that  the  postpartum  visit  occurred,  the  original  delivery  only  payment  is  retracted  and  the  delivery  + postpartum code billed is paid

Timeliness of Prenatal Care

Measurement: Deliveries  that  received  prenatal  care  visit  in  the  first  trimester  or  within  42  days of enrollment in a health plan.

Required documentation in the medical record for PRENATAL care visit:

1)A basic physical obstetrical examination that includes

** Auscultation for fetal heart tone, or ** Pelvic exam with obstetric observations, or
** Measurement of fundus height (a standardized prenatal flow sheet may be used)

2)Prenatal Care Procedure: Could be:
** Screening test/obstetric panel or ** TORCH antibody panel alone, or
** A rubella antibody test/titer with an Rh incompatibility (ABO/Rh) blood typing, or
** Ultrasound/Echography of a pregnant uterus

3)Documentation  of  LMP  or  EDD  with either prenatal  risk  assessment  &  counseling/education, or complete obstetrical history

Required coding for PRENATAL care visit:

Stand Alone Prenatal Visits
CPT: 59425, 59426,99201-99205, 99211-99215, 99241-99245, 99500
CPT II: 0500F, 0501F, 0502F
HCPCS: H1000, H1001, H1002, H1003, H1004

Anesthesia Services

Anesthesia services must be submitted with a CPT anesthesia code in the range 00100-01999, excluding 01953 and 01996, and are reimbursed as time-based using the Standard Anesthesia Formula. Refer to the attached Anesthesia Codes list for all applicable codes. For purposes of this policy the code range 00100-01999 specifically excludes 01953 and 01996 when referring to anesthesia services. CPT codes 01953 and 01996 are not considered anesthesia services because, according to the ASA RVG®, they should not be reported as time-based services.

Modifiers Required

Anesthesia Modifiers

All anesthesia services including Monitored Anesthesia Care must be submitted with a required anesthesia modifier in the first modifier position. These modifiers identify whether a procedure was personally performed, medically directed, or medically supervised. Consistent with CMS, UnitedHealthcare will adjust the Allowed Amount by the Modifier Percentage indicated in the table below.

Reimbursement Percentage

AA Anesthesia services performed personally by an anesthesiologist. 100%

AD Medical supervision by a physician: more than four concurrent anesthesia procedures. *For additional information, refer to Standard Anesthesia Formula with Modifier AD under Reimbursement Formula 100%

QK Medical direction of two, three, or four concurrent anesthesia procedures involving qualified individuals. 50%

QX Qualified nonphysician anesthetist with medical direction by a physician 50%

QY Medical direction of one qualified nonphysician anesthetist by an anesthesiologist 50%

QZ CRNA service; without medical direction by a physician. 100%

Additional anesthesia billing guidelines to consider::

• Gateway processes anesthesia services based on anesthesia procedure codes only.

• All services must be billed in minutes. Fractions of a minute should be rounded to whole minutes (30 seconds or greater: round up; less than 30 seconds: round down).

• Physical status modifiers, P1-P6, will not allow any additional payment. These are informational modifiers only and should be submitted after the pricing modifier.

• The claim should include ONLY the primary anesthesia code except when there is an addon code that should be reported along with the primary anesthesia service.


• If you provide pain management services, continue to bill with surgical codes.

• If you provide medical procedures such as Swan Ganz, Laryngoscopy Indirect with Biopsy, Venipuncture Cutdown, Placement of Catheter or Central Vein, then continue to bill with the medical procedure code.

• When billing OB anesthesia codes 01960, 01961, 01962, 01963, and 01967 you do not need to add an additional hour for patient consultation. The Department of Human Services has already added 4 to the relative value unit for these codes.

• When billing anesthesia for all obstetrical procedures, use the anesthesia procedure codes as defined in the Anesthesia section of the CPT4 manual. Should you have any questions about this communication please contact your Provider Relations Representative or Gateway’s Customer Service Department. Customer Service is available 8:30 am to 4:30 pm Monday through Friday by calling 1-800-392-1147 for Medicaid or 1-800-685-5209 for Medicare Assured.


Preventative Medicine and Sick Visits

As per AMA CPT Guidelines, Gateway shall allow reimbursement for a medically necessary sick visit Evaluation and Management (E/M) Service at the same visit as a Preventative Medicine Service (CPT 99381

– 99429) when it is clinically appropriate. Providers shall use CPT codes 99201 – 99215 to report a sick visit E/M with CPT modifier 25 to indicate that the E/M is a significant, separately identifiable service from the Preventative Medicine code reported. If modifier 25 is not appended, the sick visit will deny. Please verify with the Medicaid Fee Schedule for reimbursable Preventative Medicine Service codes.

Modifier 25 vs Modifier 57

As per AMA CPT Guidelines, Gateway will reimburse E/M Services on the same day as a global surgical procedure for the following circumstances: Modifier 25 – Significant evaluation and management service by same physician on date of global procedure

• E/M Service that is significant and separate on the day of a procedure with a 0 or 10-day global surgical periodModifier 57 – Decision for surgery made within global surgical period

• E/M Service that is the decision for surgery on the day of or on the day before a procedure with a 90-day global surgical procedure

The modifiers should be appended to the E/M Service. Absence of the modifiers will cause the E/M Service will deny as global to the procedure.


Reimbursement Formula

Base Values:

Each CPT anesthesia code is assigned a Base Value by the ASA, and UnitedHealthcare uses these values for determining reimbursement. The Base Value of each code is comprised of units referred to as the Base Unit Value.

Time Reporting: Consistent with CMS guidelines, UnitedHealthcare requires time-based anesthesia services be reported with actual Anesthesia Time in one-minute increments. For example, if the Anesthesia Time is one hour, then 60 minutes should be submitted.

Reimbursement Formulas:

Time-based anesthesia services are reimbursed according to the following formulas: Standard Anesthesia Formula without Modifier AD* = ([Base Unit Value + Time Units + Modifying Units] x Conversion Factor) x Modifier Percentage. Standard Anesthesia Formula with Modifier AD* = ([Base Unit Value of 3 + 1 Additional Unit if anesthesia notes indicate the physician was present during induction] x Conversion Factor) x Modifier Percentage.

*For additional information, Refer to Modifiers.

Qualifying Circumstances

Qualifying circumstances codes identify conditions that significantly affect the nature of the anesthetic service provided. Qualifying circumstances codes should only be billed in addition to the anesthesia service with the highest Base Unit Value. The Modifying Units identified by each code are added to the Base Unit Value for the anesthesia service according to the above Standard Anesthesia Formula.


ANESTHESIA MODIFIERS


Miscellaneous

Anesthesia Services Provided by the Operating Surgeon

Local infiltration, digital block, or topical anesthesia administered by the operating surgeon is included in the unit value for the surgical procedure.

If the attending surgeon administers anesthesia, the value shall be the lesser of the basic unit value without benefit for time or 25 percent of the total dollar value of the surgery. (See modifier 47\ for guidelines on reporting administration of anesthesia by the attending surgeon.)

Major regional anesthesia administered by the surgeon, such as a spinal epidural or major peripheral nerve block, shall be reimbursed the basic anesthesia value only without benefit for time. (See modifier 47 for guidelines on reporting administration of anesthesia by the attending surgeon.)

If the surgeon or attending physician administers a local or regional block for anesthesia during a procedure, the bill should so indicate with the use of a modifier NT for “no time.”

Nerve Block

For diagnostic or therapeutic nerve block, see 62310–62319 and 64400–64530.

For diagnostic or therapeutic nerve blocks performed by the surgeon, anesthesiologist, or CRNA, only one reimbursement per procedure shall be allowed, regardless of the time required (e.g., see codes 62310–62319, 64400–64530).

Field Avoidance

Any procedure around the head, neck, or shoulder girdle that requires field avoidance or any procedure compromising the anesthesia administration (e.g., requiring a position other than supine or lithotomy) has a minimum basic value of 5.0 units regardless of any lesser basic value assigned to such procedures. In this case, modifier 22 is required.

Multiple Procedures

Anesthesia reimbursement for multiple procedures is based on the procedure with the highest base value, plus modifying units (if appropriate), plus total time units for all combined surgical procedures.

No additional base value shall be reimbursed for anesthesia rendered during additional surgical procedures (other than the primary procedure) performed on the same day during the same operative setting.

 Procedure codes and Description

97530 Therapeutic activities, direct (one-on-one) patient contact by the provider (use of dynamic activities to improve functional performance), each 15 minutes

97532 Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact by the provider, each 15 minutes

97533 Sensory integrative techniques to enhance sensory processing and promote adaptive responses to environmental demands, direct (one-on-one) patient contact by the provider, each 15 minutes

97535 Self-care/home management training (eg, activities of daily living (ADL) and compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct one-on-one contact by provider, each 15 minutes

97537 Community/work reintegration training (eg, shopping, transportation, money management, avocational activities and/or work environment/modification analysis, work task analysis, use of assistive technology device/adaptive equipment), direct one-on-one contact by provider, each 15 minutes

97542 Wheelchair management (eg, assessment, fitting, training), each 15 minutes

Policy Overview

This policy describes Optum’s documentation requirements for reimbursement of the Physical Medicine and Rehabilitation (PM&R) CPT codes which make up the timed, skilled, direct one-on-one component of treatment. Specifically CPT codes, 97110- 97140, 97530-97542, 97750-97762.

In cases that a state determines a procedure code that is not identified by CPT as a timed therapeutic procedure will be reimbursed as a timed therapeutic procedure, the documentation requirements described in this policy will apply

Reimbursement Guidelines

Documentation Requirements – Timed Therapeutic Intervention

Optum will align timed therapeutic treatment documentation requirements with the American Physical Therapy Association’s Defensible Documentation for Patient/Client Management document and Centers for Medicare and Medicaid Services (CMS) National Policy.

Background Information

The CPT section devoted to “therapeutic procedures” contains many of the CPT codes utilized by rehabilitation providers to describe the skilled, direct one-on-one component of treatment. These codes describe the bulk of hands-on, skilled care typically provided by rehabilitation providers.

CPT defines Therapeutic Procedures 97110-97140, 97530-97542, 97750-97762 as follows:

• A manner of effecting change through the application of clinical skills and/or services that attempt to improve function.

• Physician or therapist required to have direct (one-on-one) patient contact.

• Therapeutic procedure, one or more areas, each 15 minutes;

Additionally, the definition of CPT codes 97750-97755, Therapeutic Procedures, Tests and Measurement includes, “with written report, each 15 minutes.”

In the case of the timed therapeutic CPT codes, documentation should reflect the thought process and skilled decision making of the licensed therapy provider. As such, documentation of patient/client care needs to be more than a litany of procedures related to a date of service. Documentation must include evidence of knowledge and skill related to the procedures performed. It also should provide verification of professional judgment. This concept of clinical decision making can be incorporated into clinical documentation.

General Guidelines

In addition to the documentation requirements referenced in Optum’s Guideline for Record Keeping policy, there are specific requirements that must be evident in the patient medical record for reimbursement of certain time-based therapeutic procedure interventions. Documentation of certain timed-based procedures should be recorded on the day of the patient visit and include both of the following:

A. Substantiation that the skilled services of a licensed therapy provider or physician were required.

B. Substantiation that services met the one-on-one timed-based requirement.

40. Skilled Intervention

1. Documentation to support skilled intervention is required. Demonstration of skilled care requires documentation of the type and level of skilled assistance given to the patient, clinical decision making or problem solving, and continued analysis of patient progress. This may be documented by recording both the type and amount of manual, visual, and/or verbal cues used by the licensed therapy provider to assist the patient in completing the exercise/activity completely and

correctly. Skilled care may also be documented through explanation regarding rationale for choosing the interventions and/or the rationale for the continued use of the intervention. Another way of documenting skilled care may be to provide documented observation regarding responses before, during, and after an intervention as well as the patient’s specific response to the intervention.

2. Services related to activities for the general good and welfare of patients, e.g., general exercises to promote overall fitness and flexibility and activities to provide diversion or general motivation, do not constitute skilled physical medicine and rehabilitation services. Services provided by practitioners/staff who are not qualified licensed therapy providers are not skilled intervention services. Unskilled services are palliative procedures that are repetitive or reinforce previously

learned skills, or maintain function after a maintenance program has been developed.

3. The services shall be of such a level of complexity and sophistication or the condition of the patient shall be such that the services required can be safely and effectively performed only by a licensed therapy provider. Services that do not require the skill of a licensed therapy provider are not considered skilled services, even if they are performed or supervised by a qualified professional.

4. While a patient’s particular medical condition is a valid factor in deciding if skilled physical medicine and rehabilitation services are needed, a patient’s diagnosis or prognosis should never be the sole factor in deciding that a service is or is not skilled. The key issue is whether the skills of a licensed therapy provider are needed to treat the illness or injury, or whether the services can be carried out by unskilled personnel. 

Timed and Untimed Codes

When reporting service units for HCPCS codes where the procedure is not defined by a specific timeframe (“untimed” HCPCS), the provider enters “1” in the field labeled units. For timed codes, units are reported based on the number of times the procedure is performed, as described in the HCPCS code definition.

EXAMPLE: A beneficiary received a speech-language pathology evaluation represented by HCPCS “untimed” code 92521. Regardless of the number of minutes spent providing this service only one unit of service is appropriately billed on the same day.

Several CPT codes used for therapy modalities, procedures, and tests and measurements specify that the direct (one on one) time spent in patient contact is 15 minutes. Providers report these “timed” procedure codes for services delivered on any single calendar day using CPT codes and the appropriate number of 15 minute units of service.

EXAMPLE: A beneficiary received a total of 60 minutes of occupational therapy, e.g., HCPCS “timed” code 97530 which is defined in 15 minute units, on a given date of service. The provider would then report 4 units of 97530.

Utilization Guidelines and Maximum Billable Units per Date of Service

Rarely, except during an evaluation, should therapy session length be greater than 30-60 minutes. If longer sessions are required, documentation must support as

medically necessary the duration of the session and the amount of activities/procedures performed.

The following timed modalities and procedures should be reported no more than 4 (four) units per code per day per discipline; additional units require supportive

documentation.

97032, 97110, 97112, 97113, 97116, 97124, 97140, 97530, 97532, 97533, 97535, 97537, 97542, 97760, 97761, 97762. 

General Guidelines for Therapeutic Procedures

(CPT codes 97110, 97112, 97113, 97116, 97124, 97139, 97140, 97150, 97530, 97532, 97533, 97535, 97537, 97542, 97750, 97755, 97760, 97761 and 97762)

Therapeutic procedures are procedures that attempt to reduce impairments and restore function through the applications of clinical skills and/or services.

CPT codes 97110, 97112, 97113, 97116, 97124, 97139 and 97140 are designed for one or more areas.

Use of these procedures requires the physical therapist to have direct (one-on-one) patient contact. Only the actual time of the provider’s direct contact with the patient proving a service which requires the skills and expertise of that provider is considered for coverage. Supervision of a previously taught exercise or exercise

program, patients performing an exercise independently without direct contact by the provider, or use of different exercise equipment without requiring the

intervention/skills of the therapist are not covered. The patient may be in the facility longer than that period of time, but only the time the provider is actually providing direct, one-on-one, patient contact which requires the skills of a therapist is considered covered time for these procedures, and only those minutes of treatment should be recorded.

Use of these procedures is expected to result in improvement of the limitations/deficits in a reasonable and generally predictable amount of time.

Under Medicare, time spent in documentation of services (medical record production) is part of the coverage of the respective CPT code.

CPT codes 97110, 97112, 97113, 97116, and 97530 describe several different types of therapeutic interventions. The expected goals documented in the treatment plan,

effected by the use of each of these procedures, will help define whether these procedures are reasonable and necessary. Therefore, because any one or a

combination of these procedures may be used in a treatment plan, documentation must support the use of each procedure as it relates to a specific therapeutic goal.

On each treatment visit the treatment record must support the codes billed and must specify which exercise/activity is being performed for each code billed.

Documentation must also justify the coverage of multiple services/units of each code. In general, no more than 1-2 services/units of time for each code are needed

on a date of service. Similarly, no more than 2-3 of these different codes are generally covered on a visit date. Documentation must support each code and the

number of services/units of time. For example, 10 units of time for 5 different codes would be unlikely.