CPT 96150, 96152 - Health and behavior assessment

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

96150 Assess hlth/behave init
96151 Assess hlth/behave subseq
96152 Intervene hlth/behave indiv
96153 Intervene hlth/behave group
96154 Interv hlth/behav fam w/pt

Group 2 Paragraph: The following CPT code is not covered by Medicare.


Group 2 Codes:

96155 Interv hlth/behav fam no pt


Coverage Indications, Limitations, and/or Medical Necessity

Indications

The Health and Behavioral Assessment, initial (CPT code 96150) and Reassessment (CPT code 96151), and Intervention services (CPT codes 96152-96153) may be considered reasonable and necessary for the patient who meets all of the following criteria:

The patient has an underlying physical illness or injury, and

There are indications that biopsychosocial factors may be significantly affecting the treatment or medical management of an illness or an injury, and

The patient is alert, oriented and has the capacity to understand and to respond meaningfully during the face-to-face encounter, and

The patient has a documented need for psychological evaluation or intervention to successfully manage his/her physical illness, and activities of daily living, and

The assessment is not duplicative of other provider assessments

In addition, for a reassessment to be considered reasonable and necessary, there must be documentation that there has been a sufficient change in the mental or medical status warranting re-evaluation of the patient's capacity to understand and cooperate with the medical interventions necessary to their health and well being.

Health and Behavioral Intervention (with the family and patient present) (CPT code 96154) is considered reasonable and necessary for the patient if the family representative directly participates in the overall care of the patient.
Limitations

Health and Behavioral Assessment/Intervention will not be considered reasonable and necessary for the patient who:

Does not have an underlying physical illness or injury, or
For whom there is no documented indication that a biopsychosocial factor may be significantly affecting the treatment, or medical management of an illness or injury (i.e., screening medical patient for psychological problems), or
Does not have the capacity to understand and to respond meaningfully during the face to face encounter, because of:
Dementia that has produced a severe enough cognitive defect for the psychological intervention to be ineffective.
Delirium
Severe and profound mental retardation
Persistent vegetative state/no discernible consciousness,
Impaired mental status, e.g.,

Disorientation to person, time, place, purpose, or
Inability to recall current season, location of own room, names and faces, or
Inability to recall that he or she is in a nursing home or skilled nursing facility, or
Does not require psychological support to successfully manage his/her physical illness through identification of the barriers to the management of physical disease and activities of daily living, or
For whom the conditions noted under the indications portion of this section are not met.

Because it does not represent a diagnostic or treatment service to the patient, there is no coverage for CPT code 96155.

Examples of Health and Behavioral Intervention services not considered reasonable and necessary and not covered are:

Provide family psychotherapy or mediation
Maintain the patient's or family's existing health and overall well-being
Provide personal, social, recreational, and general support services. Although such services may be valuable adjuncts to care, they are not medically necessary psychological interventions.
Individual social activities
Teaching social interaction skills
Socialization in a group setting
Vocational or religious advice
Tobacco or caffeine withdrawal support
Teaching the patient simple self-care
Weight loss management
Maintenance of behavioral logs

Health and Behavioral Assessment/Intervention (CPT codes 96150-96154) may only be performed by a Clinical Psychologist (CP-Specialty Code 68).

Biofeedback is coded as 90901 and will not be covered as a health and behavioral intervention.


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.
999x Not Applicable

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.

99999 Not Applicable



CPT code for SNF in home health or hospice setting

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

G0299 DIRECT SKILLED NURSING SERVICES OF A REGISTERED NURSE (RN) IN THE HOME HEALTH OR HOSPICE SETTING, EACH 15 MINUTES

G0300 DIRECT SKILLED NURSING SERVICES OF A LICENSE PRACTICAL NURSE (LPN) IN THE HOME HEALTH OR HOSPICE SETTING, EACH 15 MINUTES

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Neurological conditions are associated with impairments, activity limitations, and disability. Their impact on any given individual depends on the individual’s over-all health status. Health status includes environmental factors, such as the availability of palliative care services. The objective of this policy is to present a framework for identifying, documenting, and communicating the unique health care needs of individuals with neurological conditions and thus promote the over-all goal of the right care for every person, every time.

Neurological conditions may support a prognosis of six months or less under many clinical scenarios. Medicare rules and regulations addressing hospice services require the documentation of sufficient clinical information and other documentation to support the certification of individuals as having a terminal illness with a life expectancy of 6 or fewer months, if the illness runs its normal course. The identification of specific structural/functional impairments, together with any relevant activity limitations, should serve as the basis for palliative interventions and care-planning. Use of the International Classification of Functioning, Disability and Health (ICF) to help identify and document the unique service needs of individuals with neurological conditions is suggested, but not required.

The health status changes associated with neurological conditions can be characterized using categories contained in the ICF. The ICF contains domains and categories (e.g., structures of the nervous system, mental functions, sensory functions and pain, neuromusculoskeletal and movement related functions, communication, mobility, and self-care) that allow for a comprehensive description of an individual’s health status and service needs. Information addressing relevant ICF categories, defined within each of these domains and categories, should form the core of the clinical record and be incorporated into the care plan, as appropriate.

Additionally, the care plan may be impacted by relevant secondary and/or comorbid conditions. Secondary conditions are directly related to a primary condition. In the case of neurological conditions, examples of secondary conditions could include dysphagia, pneumonia, and pressure ulcers. Comorbid conditions affecting beneficiaries with neurological conditions are, by definition, distinct from the primary condition itself, however, services aimed at the comorbid condition may indeed be related to the palliation and/or management of the terminal condition. An example of a comorbid condition would be Chronic Obstructive Pulmonary Disease (COPD).

The important roles of secondary and comorbid conditions are described below in order to facilitate their recognition and assist providers in documenting their impact. The identification and documentation of relevant secondary and comorbid conditions, together with the identification and description of associated structural/functional impairments, activity limitations, and environmental factors would help establish hospice eligibility and maintain a beneficiary-centered plan of care.




Secondary Conditions:

Neurological conditions may be complicated by secondary conditions. The significance of a given secondary condition is best described by defining the structural/functional impairments - together with any limitation in activity and restriction in participation - related to the secondary condition. The occurrence of secondary conditions in beneficiaries with neurological conditions results from the presence of impairments in such body functions as consciousness, attention, sequencing complex movements, ingestion (which includes chewing, manipulation of food in the mouth, and swallowing), muscle power, tone, and endurance. These impairments contribute to the increased incidence of secondary conditions such as dysphagia, pneumonia, and pressure ulcers observed in Medicare beneficiaries with neurological conditions. Secondary conditions themselves may be associated with a new set of structural/functional impairments that may or may not respond/be amenable to treatment.

Ultimately, in order to support a hospice plan of care, the combined effects of the primary neurological condition and any identified secondary condition(s) should be such that most beneficiaries with the identified impairments would have a prognosis of six months or less.

Comorbid Conditions:

The significance of a given comorbid condition is best described by defining the structural/functional impairments - together with any limitation in activity and restriction in participation - related to the comorbid condition. For example, a beneficiary with a primary neurological condition such as Amyotrophic Lateral Sclerosis (ALS) and a comorbidity of COPD could have specific COPD-related structural and functional impairments of respiration (e.g., structural impairments of the bronchoalveolar tree resulting in increased respiratory rate, cough and impaired gas exchange) that contribute to the activity limitations and participation restrictions already present due to the respiratory muscle weakness often observed with ALS.

Such a combination could affect the palliative care plan by contributing to the individual’s dyspnea and impaired exercise tolerance. Further description/documentation using the activities and participation component of the ICF (e.g., mobility, self-care, and interpersonal interactions and relationships), would help complete the clinical picture. Palliative care aimed at relieving the dyspnea and improving the individual’s health status would be the goal.

Ultimately, in order to support a hospice plan of care, the combined effects of the primary neurologic condition and any identified comorbid condition(s) should be such that most beneficiaries with the identified impairments would have a prognosis of six months or less. The documentation of structural/functional impairments, together with the observed activity limitations, facilitate the selection of the most appropriate intervention strategies (palliative/hospice vs. long-term disease management) and provide objective criteria for determining the effects of such interventions. The documentation of these variables is thus essential in the determination of reasonable and necessary Medicare Hospice Services.




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.
N/A



Revenue Codes:

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

N/A





CPT code 92133, 92134 - SCODI

Procedure code and Description

Group 1 Paragraph: N/A

Group 1 Codes:

92132 SCANNING COMPUTERIZED OPHTHALMIC DIAGNOSTIC IMAGING, ANTERIOR SEGMENT, WITH INTERPRETATION AND REPORT, UNILATERAL OR BILATERAL

92133 SCANNING COMPUTERIZED OPHTHALMIC DIAGNOSTIC IMAGING, POSTERIOR SEGMENT, WITH INTERPRETATION AND REPORT, UNILATERAL OR BILATERAL; OPTIC NERVE


92134 SCANNING COMPUTERIZED OPHTHALMIC DIAGNOSTIC IMAGING, POSTERIOR SEGMENT, WITH INTERPRETATION AND REPORT, UNILATERAL OR BILATERAL; RETINA

Coverage Guidance


Coverage Indications, Limitations, and/or Medical Necessity

Medicare will consider scanning computerized ophthalmic diagnostic imaging (SCODI) medically reasonable and necessary in evaluating retinal disorders, glaucoma and anterior segment disorders as documented in this local coverage determination (LCD).

SCODI includes the following tests:

Confocal Laser Scanning Ophthalmoscopy (topography) uses stereoscopic videographic digitized images to make quantitative topographic measurements of the optic nerve head and surrounding retina.

Scanning Laser Polarimetry (nerve fiber analyzer) measures change in the linear polarization of light (retardation). It uses both a polarimeter (an optical device to measure linear polarization change) and a scanning laser ophthalmoscope, to measure the thickness of the nerve fiber layer of the retina.

Optical Coherence Tomography (OCT) a non-invasive, non-contact imaging technique.

OCT, especially SCODI, produces high resolution, cross-sectional tomographic images of ocular structures and is used for the evaluation of the optic nerve head, nerve fiber layer, and retina.
Scanning computerized ophthalmic diagnostic imaging allows earlier detection of glaucoma and more sophisticated analysis for ongoing management. These tests also provide more precise methods of observation of the optic nerve head and can more accurately reveal subtle glaucomatous changes over the course of time than visual fields and/or disc photos. This allows earlier and more efficient efforts of treatment toward the disease process.




Indications

Glaucoma

Glaucoma is a leading cause of blindness, and a disease for which treatment methods clearly are available and in common use. Glaucoma also is diagnostically challenging. Almost 50% of glaucoma cases remain undetected. Elevated intraocular pressure is a clear risk factor for glaucoma, but over 30% of those suffering from the disease have pressures in the normal range. 

Glaucoma commonly causes a spectrum of related eye and vision changes, including erosion of the optic nerve and the associated retinal nerve fibers, and also loss of peripheral vision. A diagnosis of glaucoma seldom is made on the basis of a single clinical observation, but instead relies upon analysis of an assemblage of clinical data, including: optic nerve, retinal nerve fiber, and anterior chamber structures, as well as looking for hemorrhages of the optic nerve, pigment in the anterior chamber, and, especially visual field loss. Each of these methods has its own strengths and limitations, thus the dependence upon multiple observations. Careful reliance upon all available clinical data can allow early treatment and can prevent unnecessary end-stage therapies.

Scanning Computer Ophthalmic Diagnostic Imaging (SCODI) allows earlier detection of those patients with normal tension glaucoma and more sophisticated analysis for ongoing management. Because SCODI detects glaucomatous damage to the nerve fiber layer or optic nerve of the eye, it can distinguish patients with glaucomatous damage irrespective of the status of intraocular pressure (IOP). It may separate patients with elevated IOP and early glaucoma damage from those without glaucoma.

Technological improvements have rendered SCODI as a valuable diagnostic tool in the diagnosis and treatment of glaucoma. These improvements enable discernment of changes of the optic nerve and nerve fiber layer, even in advanced cases of glaucoma. 

It is expected that only two (SCODI) exams/eye/year would be required to manage the patient who has glaucoma or is suspected of having glaucoma. 

Retinal Disorders

Retinal disorders are the most common causes of severe and permanent vision loss. Scanning computerized ophthalmic diagnostic imaging (SCODI) is a valuable tool for the evaluation and treatment of patients with retinal disease, especially macular abnormalities. SCODI is able to detail the microscopic anatomy of the retina and the vitreo-retinal interface. SCODI is useful to measure the effectiveness of therapy, and in determining the need for ongoing therapy, or the safety of cessation of that therapy.

Retinal thickness analysis is a non-invasive and non-contact imaging technique that takes direct cross-sectional images of the retina. These high resolution images capture ocular structures and provide data to create thickness maps of the retina. Retinal thickness is directly correlated to ocular disease, including retinal disorders and glaucoma. In contrast, Scanning Laser Polarimetry is not an appropriate diagnostic technique for the management of retinal disorders.

Long Term Use of Chlorquine (CQ) and or Hydroxychloroquine (HCQ)

Clinical evidence has shown that long-term use of chloroquine (CQ) and/or hydroxychloroquine (HCQ) can lead to irreversible retinal toxicity. Therefore, these two medications are deemed high risk, and scanning optical coherence tomography may be indicated to provide a baseline prior to starting the medication and as an annual follow-up. Clinical evidence shows that the resolution of time domain OCT instruments is not sufficient to detect early toxic retinal changes. Because of that, spectral domain-optical coherence tomography (SD-OCT) is expected to be used to detect retinal changes that are due to the use of CQ or HCQ. 

Anterior Segment Disorders

SCODI may be used to examine the structures in the anterior segment structures of the eye. However, it is still seen as experimental/investigational except in the following:
Narrow angle, suspected narrow angle, and mixed narrow and open angle glaucoma

Determining the proper intraocular lens for a patient who has had prior refractive surgery and now requires cataract extraction

Iris tumor

Presence of corneal edema or opacity that precludes visualization or study of the anterior chamber

Calculation of lens power for cataract patients who have undergone prior refractive surgery. Payment will only be made for the cataract codes as long as additional documentation is available in the patient record of their prior refractive procedure. Payment will not be made in addition to A-scan or IOL master.

Limitations

The following codes/ procedures would generally not be necessary with SCODI. When medically needed the same day, documentation must justify the procedures.
92250 - Fundus photography with interpretation and report

92225 - Opthalmoscopy extended with retinal drawing (e.g. For retinal detachment, melanoma) with interpretation and report initial

92226 - Subsequent ophthalmoscopy

76512 - B-scan (with or without superimposed non-quantitative A-scan)




ICD-10 Codes that Support Medical Necessity 

ICD-10 CODE DESCRIPTION

C69.01 Malignant neoplasm of right conjunctiva

C69.02 Malignant neoplasm of left conjunctiva

C69.11 Malignant neoplasm of right cornea

C69.12 Malignant neoplasm of left cornea

C69.21 Malignant neoplasm of right retina

C69.22 Malignant neoplasm of left retina

C69.31 Malignant neoplasm of right choroid

C69.32 Malignant neoplasm of left choroid

C69.41 Malignant neoplasm of right ciliary body

C69.42 Malignant neoplasm of left ciliary body

C69.51 Malignant neoplasm of right lacrimal gland and duct

C69.52 Malignant neoplasm of left lacrimal gland and duct

C69.61 Malignant neoplasm of right orbit

C69.62 Malignant neoplasm of left orbit

C69.81 Malignant neoplasm of overlapping sites of right eye and adnexa

C69.82 Malignant neoplasm of overlapping sites of left eye and adnexa

D31.01 Benign neoplasm of right conjunctiva

D31.02 Benign neoplasm of left conjunctiva

D31.11 Benign neoplasm of right cornea

D31.12 Benign neoplasm of left cornea

D31.21 Benign neoplasm of right retina

D31.22 Benign neoplasm of left retina

D31.31 Benign neoplasm of right choroid

D31.32 Benign neoplasm of left choroid

D31.41 Benign neoplasm of right ciliary body

D31.42 Benign neoplasm of left ciliary body

D31.51 Benign neoplasm of right lacrimal gland and duct

D31.52 Benign neoplasm of left lacrimal gland and duct

D31.61 Benign neoplasm of unspecified site of right orbit

D31.62 Benign neoplasm of unspecified site of left orbit

D31.91 Benign neoplasm of unspecified part of right eye

D31.92 Benign neoplasm of unspecified part of left eye

H16.001 Unspecified corneal ulcer, right eye

H16.002 Unspecified corneal ulcer, left eye

H16.003 Unspecified corneal ulcer, bilateral

H16.011 Central corneal ulcer, right eye

H16.012 Central corneal ulcer, left eye

H16.013 Central corneal ulcer, bilateral

H16.021 Ring corneal ulcer, right eye

H16.022 Ring corneal ulcer, left eye

H16.023 Ring corneal ulcer, bilateral

H16.031 Corneal ulcer with hypopyon, right eye

H16.032 Corneal ulcer with hypopyon, left eye

H16.033 Corneal ulcer with hypopyon, bilateral

H16.041 Marginal corneal ulcer, right eye

H16.042 Marginal corneal ulcer, left eye

H16.043 Marginal corneal ulcer, bilateral

H16.051 Mooren's corneal ulcer, right eye

H16.052 Mooren's corneal ulcer, left eye

H16.053 Mooren's corneal ulcer, bilateral

H16.061 Mycotic corneal ulcer, right eye

H16.062 Mycotic corneal ulcer, left eye

H16.063 Mycotic corneal ulcer, bilateral

H16.071 Perforated corneal ulcer, right eye

H16.072 Perforated corneal ulcer, left eye

H16.073 Perforated corneal ulcer, bilateral

H18.11 Bullous keratopathy, right eye

H18.12 Bullous keratopathy, left eye

H18.13 Bullous keratopathy, bilateral

H18.20 Unspecified corneal edema

H18.211 Corneal edema secondary to contact lens, right eye

H18.212 Corneal edema secondary to contact lens, left eye

H18.213 Corneal edema secondary to contact lens, bilateral

H18.221 Idiopathic corneal edema, right eye

H18.222 Idiopathic corneal edema, left eye

H18.223 Idiopathic corneal edema, bilateral

H18.231 Secondary corneal edema, right eye

H18.232 Secondary corneal edema, left eye

H18.233 Secondary corneal edema, bilateral

H18.50 Unspecified hereditary corneal dystrophies

H18.51 Endothelial corneal dystrophy

H18.711 Corneal ectasia, right eye

H18.712 Corneal ectasia, left eye

H18.713 Corneal ectasia, bilateral

H18.721 Corneal staphyloma, right eye

H18.722 Corneal staphyloma, left eye

H18.723 Corneal staphyloma, bilateral

H18.731 Descemetocele, right eye

H18.732 Descemetocele, left eye

H18.733 Descemetocele, bilateral

H40.021 Open angle with borderline findings, high risk, right eye

H40.022 Open angle with borderline findings, high risk, left eye

H40.023 Open angle with borderline findings, high risk, bilateral

H40.031 Anatomical narrow angle, right eye

H40.032 Anatomical narrow angle, left eye

H40.033 Anatomical narrow angle, bilateral

H40.061 Primary angle closure without glaucoma damage, right eye

H40.062 Primary angle closure without glaucoma damage, left eye

H40.063 Primary angle closure without glaucoma damage, bilateral

H40.1110 Primary open-angle glaucoma, right eye, stage unspecified

H40.1111 Primary open-angle glaucoma, right eye, mild stage

H40.1112 Primary open-angle glaucoma, right eye, moderate stage

H40.1113 Primary open-angle glaucoma, right eye, severe stage

H40.1114 Primary open-angle glaucoma, right eye, indeterminate stage

H40.1120 Primary open-angle glaucoma, left eye, stage unspecified

H40.1121 Primary open-angle glaucoma, left eye, mild stage

H40.1122 Primary open-angle glaucoma, left eye, moderate stage

H40.1123 Primary open-angle glaucoma, left eye, severe stage

H40.1124 Primary open-angle glaucoma, left eye, indeterminate stage

H40.1130 Primary open-angle glaucoma, bilateral, stage unspecified

what is cost outlier - occurrence code OC 47, 70, 61

Definitions

Cost outlier -- an inpatient hospital discharge that is extraordinarily costly. Hospitals may be eligible to receive additional payment for the discharge. Section 1886(d)(5)(A) of the social security act provides for Medicare payments to Medicare-participating hospitals in addition to the basic prospective payments for cases incurring extraordinarily high costs.

• To qualify for outlier payment, a case must have costs above a fixed-loss cost threshold amount (a dollar amount by which the costs of a case must exceed payments to qualify for outliers).

• Total covered charges for an inpatient admission are $100,000 (hospital costs)

• The prospective payment system (PPS) threshold amount for the DRG is $65,000 (fixed-loss threshold amount)

• The Centers for Medicare & Medicaid Services (CMS) publishes the outlier threshold amounts in the annual inpatient prospective payments system (IPPS) final rule. Providers may access CMS' website to download the IPPS pricer.

• Inlier -- a case where the cost of treatment falls within the established cost boundaries of the DRG payment. To determine if the inpatient hospital claim meets the criteria for cost outlier reimbursement, two pieces of information are needed: 1) total covered charges and 2) PPS threshold amount. If the total covered charges exceed the PPS threshold amount, follow the coding rules for inpatient cost outlier claims.

• DRG cutoff day -- the "To" date or "End" date of the inlier period. Once the PPS threshold amount is known add the daily covered charges incurred by the patient until determining the day that covered charges reach the cost outlier threshold amount. Exclude days and charges during noncovered spans (e.g., occurrence span code 74 [noncovered level of care], 76 [patient liability], 79 [payer code] dates).

Occurrence code (OC) 47 -- a code that indicates the first day the inpatient cost outlier threshold is reached or the date after the DRG cutoff date. For Medicare purposes, a beneficiary must have regular coinsurance and/or lifetime reserve days available beginning on this date to allow coverage of additional daily charges for the purpose of making cost outlier payments. OC47 date cannot be equal to or during dates coded for occurrence span code 74, 76, or 79. Click here for an example. pdf file

Occurrence code A3 -- (Benefits Exhausted) the last date for which benefits are available and after which no payment can be made.

Occurrence span code 70 -- a code and span of time that indicates the from and through dates during the PPS inlier stay for which the beneficiary has exhausted all regular days and/or coinsurance days, but which is covered on the cost report. Click here for an example. pdf file

• Condition code 61 -- a code that indicates this bill is a cost outlier. Click here for an example. pdf file

• Condition code 67 -- a code that indicates the beneficiary has elected not to use lifetime reserve (LTR) days.

• Condition code 68 -- a code that indicates the beneficiary has elected to use lifetime reserve (LTR) days.


Q: When should occurrence span code (OSC) 70 be used?

A: OSC70 should be coded on the cost outlier claim when the beneficiary’s benefit days have exhausted and there are extra days within the inlier portion of the claim. The claim may be paid up to the diagnosis related group (DRG), as long as there are benefit days remaining for the claim.

Answering this question will assist in submitting the claim correctly. Did the beneficiary’s regular, coinsurance or life time reserve days exhaust during the inlier portion of the stay?

• If no -- submit claim as regular inpatient claim or follow guidelines for using occurrence code 47 and A3, if applicable.
• If yes --
• Did the regular benefit days exhaust during the inlier period?
• Indicate occurrence span code 70.
• Did life time reserve days exhaust during the inlier period? Note: Lifetime reserve days can be billed only in the inlier period when these are the only benefit days available at the time of admission.
• The from and through dates should represent the period of time during the prospective payment system (PPS) inlier stay for which the benefit days are exhausted.

If a beneficiary has at least one regular benefit day remaining in the benefit period available for use at the time of admission, the entire stay up to the DRG cutoff will be paid for by Medicare.

All charges for dates within the occurrence span code 70 should be billed as covered.

Definition

• OSC 70 -- Non-utilization dates (for payer use on hospital bills only). The from/through dates during a prospective payment system (PPS) inlier stay for which the beneficiary has exhausted all regular days and/or coinsurance days, but which is covered on the cost report.


Q: Should a claim be submitted as a cost outlier?

A: Yes, we encourage you to code the claim appropriately when submitting it the first time. You have access to the Centers for Medicare & Medicaid Services’ (CMS) PRICER software external link which helps you determine the prospective payment system (PPS) threshold. Once you determine the PPS threshold and confirm the claim can be submitted as a cost outlier, you should code the claim appropriately and forward to the fiscal intermediary standard system (FISS).

To determine if the inpatient hospital claim meets criteria for cost outlier reimbursement, you need two pieces of information:
• Total covered charges, and
• PPS threshold amount

If the total covered charges exceed the PPS threshold amount by CMS’ published standards for the current year, then you should follow the coding rules for inpatient cost outlier claims.


Occurrence code 47 -- indicates the first day the inpatient cost outlier threshold is reached or the date after the diagnostic related group (DRG) cutoff date. For Medicare purposes, a beneficiary must have regular coinsurance and/or lifetime reserve days available beginning on this date to allow coverage of additional daily charges for the purpose of making cost outlier payments. Occurrence code 47 cannot be equal to or during the dates of occurrence span code 74 or 76.

Occurrence span code 74 -- the from/through dates for a period at a non-covered level of care in an otherwise covered stay, excluding any period reported with occurrence span codes 76, 77, or 79. Codes 76 and 77 apply to most non-covered care. Used for leave of absence, or for repetitive part B services to show a period of inpatient hospital care or outpatient surgery during the billing period. Also used for home health association (HHA) or hospice services billed under part A, but not valid for HHA under prospective payment system (PPS).

Occurrence span code 76 -- the from/through dates for a period of non-covered care for which the provider is permitted to charge the beneficiary. Codes should be used only where the Medicare administrative contractor (MAC) or fiscal intermediary (FI)of the quality improvement organization (QIO) has approved such charges in advance and the patient has been notified in writing three days prior to the ‘from’ date of this period.


Q: When is it appropriate to use occurrence code 47 when submitting an inpatient cost outlier claim?

A: Reference the Outlier Flowchart pdf file after asking this question: Does the cost for an inpatient stay exceed the cost outlier threshold amount?
• If no -- submit claim as regular inpatient claim.
• If yes -- are there enough benefit days (regular or life time reserve) to cover the medically necessary days?
• If yes -- submit claims as regular inpatient claim. Do not indicate occurrence code 47.
• If no -- indicate occurrence code 47 and date of the first full day of cost outlier status (the day after the day that covered charges reach the cost outlier threshold).
• For Medicare purposes, cost outlier payments are paid for each day during the outlier period that the beneficiary has an available benefit day (regular, coinsurance, and/or life time reserve).
• Diagnosis related group (DRG) claims without cost outlier payments can never have regular benefit days combined with life time reserve benefit days. When regular benefit and life time reserve days are billed on the same claim, life time reserve usage begins on the cost outlier date (should be equal to occurrence code 47 date).


cpt code 88341, 88342, 88360

Procedure code and Description

88312 SPECIAL STAIN INCLUDING INTERPRETATION AND REPORT; GROUP I FOR MICROORGANISMS (EG, ACID FAST, METHENAMINE SILVER)

88313 SPECIAL STAIN INCLUDING INTERPRETATION AND REPORT; GROUP II, ALL OTHER (EG, IRON, TRICHROME), EXCEPT STAIN FOR MICROORGANISMS, STAINS FOR ENZYME CONSTITUENTS, OR IMMUNOCYTOCHEMISTRY AND IMMUNOHISTOCHEMISTRY

88341 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH ADDITIONAL SINGLE ANTIBODY STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

88342 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; INITIAL SINGLE ANTIBODY STAIN PROCEDURE

88344 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH MULTIPLEX ANTIBODY STAIN PROCEDURE

88360 MORPHOMETRIC ANALYSIS, TUMOR IMMUNOHISTOCHEMISTRY (EG, HER-2/NEU, ESTROGEN RECEPTOR/PROGESTERONE RECEPTOR), QUANTITATIVE OR SEMIQUANTITATIVE, PER SPECIMEN, EACH SINGLE ANTIBODY STAIN PROCEDURE; MANUAL

88361 MORPHOMETRIC ANALYSIS, TUMOR IMMUNOHISTOCHEMISTRY (EG, HER-2/NEU, ESTROGEN RECEPTOR/PROGESTERONE RECEPTOR), QUANTITATIVE OR SEMIQUANTITATIVE, PER SPECIMEN, EACH SINGLE ANTIBODY STAIN PROCEDURE; USING COMPUTER-ASSISTED TECHNOLOGY

Coverage Guidance
Coverage Indications, Limitations, and/or Medical Necessity

This policy does not designate specific special histochemical stains (aka special stains) and/or immunohistochemical (IHC) stains that should be used in the differential diagnosis of tissues or neoplasms because this information is readily available in text books and various scientific publications. This policy identifies the medically necessary criteria for the use of special stains and/or IHC stains and addresses, based on claims review, the scenarios that may be driving medically unnecessary over-utilization or incorrect billing of these services including:
Reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist; or

Use of special stains and/or IHC stains without clinical evidence that the stain is actionable or provides the treating physician with information that changes patient management, or

Use of added stains when the diagnosis is already known based on morphologic evaluation of the primary stain.


Background

Routine hematoxylin and eosin (H&E) staining is the corner stone of tissue-based microscopic diagnosis. Thin sections of tissue are stained with H&E to visualize the tissue morphology. Hematoxylin dye stains the cell nuclei blue and the eosin dye stains other structures pink/red. H&E staining provides excellent detail required for tissue-based diagnosis and is NOT a separately billable service, as reimbursement for pathology services includes routine H&E staining. At least one lab has touted “acid hematoxylin” as a special stain for purposes of billing Medicare and private payers. Given that all hematoxylin stains are acidic and that this stain has never been recognized by the Biological Stain Commission, it is incorrect coding to present claims for this stain as a special stain. Hematoxylin and eosin (H&E) staining is included in the billing CPT code and is not a separately billable service.

Special stains are called “special” because they are dyes used to stain particular tissues, structures or pathogens such as bacteria that may not be visible by routine H&E staining. Special stains can identify whether a substance is present or absent, where the substance is located in the tissue specimen, and frequently, how many or how much of a substance is present. There are special stains to identify bacteria, yeast and fungi; for connective tissue, muscle, collagen, lipid and fibrin; for nuclei acids; and multi-purpose stains to identify basement membranes, mucins, and various other cellular constituents. Two major AMA CPT coding categories for special stains are recognized: One is specifically for microorganisms; the second code is for all other purposes (not microorganisms) and specifically excludes detection of enzyme constituents.

IHC is a powerful tool for identifying substances and cells in tissue sections using the specificity of antigen-antibody reactions, where the antibody is linked to a colored indicator (stain) that can be seen with a microscope. More than 400 distinct antibody targets are currently available with varying sensitivity and specificity for a given target. A major use of IHC is to identify poorly differentiated malignant neoplasms (tumors) such as a carcinoma, lymphoma, melanoma and sarcoma. Some IHC stains are useful in determining the primary site of a metastatic neoplasm, and others are used to guide specific therapies (e.g., Her2 IHC to determine potential response to trastuzumab).

Medical Necessity of Services Performed

There are many different relationships that exist in providing the provision of pathology services in the United States. Some physicians, groups, laboratories and hospitals submit global claims for the services described in this policy. In other instances, there are separate individuals or entities providing the professional (-26) and the technical services (-TC). It is the obligation of each billing party to recognize that they are responsible for the medical necessity of the charges submitted. For example, when a physician or physician group bills for the professional component of services described in this policy and another entity bills for the technical services, it is the obligation of each entity to independently assure the medical necessity of the services rendered and billed.

Special Stains/IHC Medical Necessity

The IOM, Benefit Policy Manual (CPT15, §80.6.5) specifies “…there may be additional tests, such as special stains, that the pathologist may need to perform, even though they have not been specifically requested by the treating physician/practitioner. The pathologist may perform such additional tests under the following circumstances:
Services are medically necessary so that a complete and accurate diagnosis can be reported to the treating physician/practitioner;

Results of the tests are communicated to and are used by the treating physician/practitioner in the treatment of the beneficiary; and

Pathologist documents in his/her report why additional testing was done.”


The above citation means that reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine hematoxylin and eosin (H&E) stain by the pathologist are not reasonable and necessary. A pathologist must first review the H&E stain prior to ordering special stains or IHC.

Exceptions do exist and are recognized standards of care in the practice of pathology. These exceptions include but are not limited to renal, liver, and neuromuscular biopsies, and for the suspicion of an infectious disease, particularly in an immune compromised patient. In certain clearly defined circumstances, it may be reasonable to perform some IHC on sentinel lymph nodes when the frozen sections show they are free of tumor.

The medical necessity for the special stain or IHC studies, and the results of the stain or IHC, must be documented in the surgical pathology report.

IHC for Breast Pathology

The clinical care of patients with breast cancer depends upon the accurate diagnosis and the assessment of biomarkers. Hormone receptor assays and Her2 testing are recommended on all primary invasive breast cancers, and on recurrent or metastatic cancers. At the current time, there is no recommendation for Her2 testing on in situ breast lesions outside of a clinical trial. While there are a number of promising additional biomarkers, such as Ki-67, PI3K and gene expression assays, the College of American Pathologists (CAP), the American Society of Clinical Oncologists (ASCO) and the National Comprehensive Cancer Network (NCCN) have not recognized these markers in patient treatment pathways.

Estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (Her2) are well-established prognostic markers in invasive breast cancer management. The triple negative breast carcinoma subtype (ER-/PR-/Her2-) has been associated with worse overall prognosis in comparison with other subtypes in study populations consisting of ethnic minorities and young women.

Ki-67 expression is a biomarker for proliferation and has been associated with response to therapy, but methods of measurement are controversial. In December, 2013, the CAP reported that there is “a lack of consensus on scoring, definition of low versus high expression, an appropriate cut point for positivity, or which part of the tumor should be scored (e.g., leading edge, hot spots, overall average). There is also paucity of data on the effects of pre-analytical variables (e.g., ischemic time, length of fixation, antigen retrieval) on Ki-67 staining. For these reasons, routine testing of breast cancers for Ki-67 expression is not currently recommended by either ASCO or the NCCN." Consequently, Ki-67 is not reasonable and necessary for breast cancer and will not be covered by Medicare.

The clinical utility of testing for hormone receptors in in-situ breast cancer differs from those of invasive disease. Guidelines and the peer reviewed literature support the use of ER testing for in-situ breast neoplasia and PR testing only when the ER status is negative (Lester, personal communication). Clinical guidelines have not been established for the use of Her2 or other biomarkers in patients with non-invasive breast neoplasia.

In the absence of professional guidelines based on proven scientific literature, standing orders from clinicians for such tests as Ki-67 and EGFR on every breast cancer are not reasonable and necessary, and are not a covered Medicine service.

In addition, basal phenotype markers (e.g., IHC for CK5) are not routinely necessary. Neither are IHC stains such as E-cadherin, p27, or high molecular weight cytokeratin to distinguish ductal from lobular differentiation necessary on every breast case, nor are myoepithelial cell markers such as p63 or smooth muscle myosin heavy chain necessary on every case.

Special Stains and/or IHC for GI Pathology

Pathologists are often called upon to microscopically diagnose abnormalities seen on endoscopic exam of the esophagus, stomach, duodenum and colon. Biopsy specimens constitute an important diagnostic patient service. Most normal and abnormal conditions of these organs can be detected by the use of routine H&E stain.

Ordering special stains or IHC stains prior to review of the routine H&E stain is not reasonable and necessary. For most esophageal, gastric and duodenal specimens, it is not reasonable or necessary to perform special stains such as alcian blue – periodic acid Schiff (AB-PAS), or other mucin stains, such as diastase – PAS (D-PAS), or IHC stains such CDX-2 to determine if clinically meaningful intestinal metaplasia is present. In addition, it is not usually reasonable and necessary to perform special stains or IHC to determine the presence of H. pylori organisms.

Other examples of special stains or IHC that are not reasonable and necessary on every specimen include:

Esophagus – fungal stains, trichrome, DPAS, CDX-2 or other mucin stains

Gastric – AB-PAS, D-PAS, CDX-2 or other mucin stains, or special stains or IHC for H. pylori, or neuroendocrine markers such as synaptophysin or chromogranin

Duodenum – AB-PAS, D-PAS, CD3, and trichrome, or other mucin stains

Colon – CD3, p53 trichrome

Hyperplastic polyps – Ki67, CK20, p53, CEA, BRAF

Tubular or tubulovillous adenoma – Ki-67, CK20, CEA, p53, MMR


If special stains or IHC are needed in addition to the routine H&E for gastric specimens, specific documentation to justify the medical necessity for the stain is required in the pathology report. Cases that may require special stains or IHC include but are not limited to the following:

Detection of H pylori in an appropriate milieu when organisms are not seen on H&E stained slides;

Evaluating atrophic gastritis for evidence of autoimmune etiology and for enterochromaffin-like (ECL) cell hyperplasia/carcinoid tumor

Characterizing a carcinoma, lymphoma, melanoma or sarcoma

Defining a GIST tumor and to distinguish it from mimics

Ki-67 by IHC in the differential diagnosis of certain neuroendocrine tumors of the gut


Scientific data demonstrates that the combined number of gastric biopsies requiring special stains or IHC is roughly 20% of biopsies received and examined in a pathology practice. GI specialty practices with a large GI referral base or GI consultant pathologists may sometimes exceed this relative number of special stains/IHC, but one would not expect to see routine high utilization of special stains or IHC.

Over-utilization of special stains has also been observed with duodenal biopsies where CD3 and AB/D-PAS are reportedly used to help exclude intraepithelial lymphocytosis and gastric metaplasia. Both of these conditions, if present, are easily recognizable on H&E morphology. Mucin stains such as AB-PAS or DPAS would be reasonable and necessary in limited circumstances, and rarely is CD3 warranted on duodenal biopsies which show villous architectural abnormalities.

Architectural and histologic features define colonic polyps including hyperplastic, inflammatory, and adenomatous lesions. Special stains and/or IHC stains are not reasonable and necessary for colon polyps despite text books noting, for example, thickened subepithelial collagen demonstrated by trichrome or collagen staining in hyperplastic polyps, or carcinoembryonic antigen (CEA) overexpression in hyperplastic polyps. While the information is of academic interest, special stains are not reasonable and necessary to make the diagnosis of various colonic polyps.

Lynch Syndrome tumor screening for DNA mismatch repair (MLH1, MSH2, MSH6 and PMS2) by qualitative IHC and/or microsatellite instability (MSI) is considered medically necessary and covered by Medicare for the following indications:

All individuals with colorectal cancer diagnosed at age =70 years of age, and those > 70 years of age who meet the revised Bethesda guidelines OR

Individuals with endometrial cancer


No definitive algorithm for LS screening has been recommended. However, if IHC is done first and is abnormal, MSI testing is not warranted. If IHC is normal, MSI may be warranted. IHC testing Lynch syndrome is qualitative and does not require the use of tumor morphometry.

Special Stains and/or IHC for Prostate Pathology

The accuracy of the pathologic diagnosis of prostate cancer is critical for optimal patient care. The diagnosis can usually be made on morphologic features such as growth pattern, nuclear atypia and the absence of basal cells. However, it may be difficult to reach a firm diagnosis by routine H&E stain for small foci of cancer in needle biopsies because many benign conditions can mimic prostate cancer.

The immunohistochemical diagnosis of prostate cancer largely depends on panels of markers because no absolutely specific and sensitive marker for prostate cancer has yet been identified. These panels usually include at least one basal cell marker, such as high-molecular-weight cytokeratin (HMWCK) or p63, and the prostate cancer-specific marker, alpha-methyl-CoA-Racemase (AMACR). Although AMACR is considered a useful IHC marker for prostate cancer, because of non-standardized immunostaining protocols, interpretation criteria and heterogeneous staining pattern, there is wide variation in the sensitivity and specificity of AMACR immunoreactivity in prostate biopsies. Furthermore, because AMACR expression has been demonstrated in high-grade PIN, atypical adenomatous hyperplasia/adenosis and nephrogenic adenoma, it is recommended that AMACR is best restricted to the evaluation of morphologically highly suspicious foci in which negative immunoreactivity of basal cell markers alone is insufficient to establish a diagnosis of cancer.

PTEN and MYC may provide some prognostic information but neither is part of any standard treatment protocol and neither should be routinely performed. ERG is another IHC that is more likely to be positive in cancer than in benign tissue, but it does not add information to conventional PIN4 testing. Similarly, neuroendocrine markers, such as IHC for synaptophysin, may be indicated in cases of recurrent/metastatic prostate carcinoma that have undergone small cell transformation after hormone therapy. The latter marker is only necessary for high grade, undifferentiated tumors and should not be used routinely.

PIN4 is an IHC cocktail of CK5/14, p63 and P504S that is used primarily to differentiate normal and neoplastic epithelial tissues. In prostate tissue, CK5 and CK14 are detected in basal cells of normal glands and prostatic intraepithelial neoplasia (PIN) which is a precursor lesion to prostatic adenocarcinoma. However, expression of CK5 and CK14 is not identified in invasive prostatic adenocarcinoma. P63 is detected in nuclei of basal epithelium in normal prostate glands, but is not expressed in malignant prostate tumors. Because P504S (aka AMACR) is not specific for prostatic adenocarcinoma, the use of PIN4 is best restricted to evaluation of morphologically highly suspicious foci.

It is not reasonable and necessary to bill for IHC testing (either single antibody or antibody cocktails) on cases with morphologically negative cores. It is not reasonable and necessary to bill for IHC testing in a negative or a suspicious core biopsy when obvious prostate cancer is present in other cores. While the pathologist may choose to confirm a suspicious focus in one or more cores in a case where the diagnosis of cancer has already been made, it is not a Medicare covered service because it provides no additional actionable information to the treating physician.

Prostate cases that may require reasonable and necessary IHC staining include but are not limited to the following:
Indeterminate/suspicious focus and no other cores are positive for cancer;

Single worrisome core with minimal percent tumor (roughly <5 p="">
Worrisome core(s) contralateral to a positive core(s);

o In a multi-part biopsy with Gleason 3+3=6 cancer in 1 part, and atypical small acinar proliferation (ASAP) suspicious for Gleason 3+3=6 cancer in other part(s); the number of positive biopsy sites and % core involvement of these sites can affect therapeutic choices for active surveillance (AS), focal therapy or surgery;
o In a multi-part biopsy with 4+3=7 or 4+4=8 cancer in 1 part, and ASAP suspicious for the same grade cancer in other part(s); workup is justified since the extent of high grade cancer affects treatments;

Identify tumor invasion of adjacent structures;

Determine origin of undifferentiated/poorly differentiated neoplasm, such as bladder vs prostate;

Other unexpected results when specific cell stains would be necessary


Prostate cases when IHC workup is Not Reasonable and Necessary include the following:
In a multi-part biopsy with = 3+4=7 cancer in 1 part, and ASAP suspicious for 3+3=6 cancer in other part(s), because stains are unlikely to change treatment; or


In a multi-part biopsy with = 4+3=7 cancer in 1 part, and "atypical cribriform lesson" (ACL) suspicious for intra-ductal carcinoma versus invasive, Gleason pattern 4 cancer in other part(s), because intra-ductal carcinoma is almost always closely associated with invasive high-grade cancer.


The International Society of Pathology (ISUP) recommendations state that at the current time, there are no prognostic IHC or molecular studies that are recommended to be routinely performed on biopsy or resection specimens.

The surgical pathology report is expected to designate the specific block(s) upon which IHC testing is performed, the reason for IHC testing, the specific markers, and whether single antibody(ies) or a cocktail of antibodies is utilized. A statement alone in the pathology report that states “IHC confirms the diagnosis” will not be covered as reasonable and necessary.

Special Stains and/or IHC for Lung Cancer

The diagnostic challenge of a lung biopsy can often prompt the need for additional stains to define the neoplasm. Two important considerations need to be considered in this regard:
The diagnosis of squamous cell cancer can often be made without the use of any special stains, and

The diagnosis of non-small cell carcinoma often requires additional stains but it is essential that tumor tissue be carefully triaged to allow the patient’s sample to be tested for molecular markers (EGFR, ALK, and others) when clinically indicated.


Experts in pulmonary pathology recommend starting the evaluation of non-small cell carcinomas with a combination of TTF-1 and p40 or p63 IHCs. Often these two stains are all that are needed to come to a reasonable diagnosis and retain enough tumor sample to complete molecular studies. In rare patients, a few additional IHCs or mucin stains may be needed.

Ki-67/MIB-1

Ki-67 and MIB-1 monoclonal antibodies are directed against different epitopes of the same proliferation-related antigen. These stains are used to determine the proliferative rate of a tumor. Ki-67 antigen or protein (hereafter Ki-67) is present during all active phases of the cell cycle (G1, S, G2, and mitosis), but is absent from resting cells (G0). By measuring the amount of tumor cells expressing Ki-67, an estimate of DNA synthesis can be determined which has been found comparable to a mitotic count performed on a standard H&E slide. Furthermore, Ki-67/MIB-1 antibodies have suffered from a lack of international standardization which has limited their clinical usefulness. This is noted above in the discussion of breast cancers.

Classification of lung neuroendocrine (NE) tumors is a step-wise process with four tumor categories being identified by morphology, namely:
Typical carcinoid (TC),

Atypical carcinoid (AC),

Large cell NE carcinoma, and

Small cell lung carcinoma (SCLC).


Ki-67 has potential usefulness in a narrow range of pathologic lung cases. Namely, it allows better classification of atypical and typical lung carcinoid tumors, and in pulmonary neuroendocrine tumors with extensive crush artifact. (As noted above, Ki-67 may be useful in the classification of some gut neuroendocrine tumors.)

Ki-67 by IHC has clinical utility in the workup of lymphomas. Ki-67 has several established applications including:

Final confirmation for the diagnosis of any low-grade lymphoma. A number of publications show a worse prognosis for follicular lymphomas which appear to be grade 1 or 2 but demonstrate high Ki-67 labeling. Similarly, small lymphocytic lymphomas/CLL with a high proliferative rate (“prolymphocytic progression”) may be best detected with Ki-67.

Distinguishing higher versus lower grade mantle cell lymphoma. A small percentage of cases behave as low grade rather than intermediate grade, and Ki-67 is the most accurate means to detect this subgroup. In addition, distinguishing the highly aggressive blastoid variant is aided by Ki-67 IHC testing.

Recognizing Burkitt and Burkitt-like grouping as distinct from diffuse large B-cell type. One of the most important qualifying criteria is Ki-67 labeling at greater than 90%.

Plasma cell myeloma proliferative rate has long been established as one of the most accurate prognostic markers.


IHC for Chemosensitivity and Resistance Tumor Profiling

ER, PR, and Her2 hormonal receptor status have demonstrated clinical utility in invasive breast cancer, as well as ER, and PR when appropriate, for in-situ breast cancer. ER and PR are performed by IHC specifically for tamoxifen therapy. Her2 testing has proven clinical utility in esophago-gastric and gastric cancers to determine response to trastuzumab. ER, PR and Her2 testing for the purpose of identifying patients likely to respond to hormonal therapy, biologics or chemotherapy is a covered Medicare service when medically necessary for breast and gastric adenocarcinoma.

Similarly, the efficacy of imatinib, a CD117 inhibitor, is determined by the mutation status of CD117 expression (c-KIT mutation). CD117 by IHC has a proven clinical benefit in gastrointestinal stromal tumors (GIST), some advanced dermatofibrosarcoma protuberans (DFSP), some lymphoblastic and myeloid leukemias, and mast cell tumors, and is a covered Medicare service when medically necessary.

However, IHC testing as above is distinctly different from chemotherapy sensitivity and/or resistance testing profiles offered by some labs to assist physicians in their selection of specific chemotherapeutic agents based on IHC antigen or protein expression in individual tumors. The goal stated by these profiles is to select a drug or combination of drugs from a panel of drugs to which a tumor has greater expression, and to avoid drugs to which the tumor has less expression.

Neither the ASCO nor the NCCN has endorsed chemosensitivity tumor profile testing by IHC. ASCO has stated, "the use of CSRA's (chemosensitivity and resistance assays) to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting." While the NCCN's Guidelines for Ovarian Cancer (V3.2014) states "chemosensitivity/resistance and/or other biomarker assays are being used in some NCCN member institutions for decisions related to future chemotherapy in situations where there are multiple equivalent chemotherapy options available. The current level of evidence is not sufficient (Category 3) to supplant standard of care chemotherapy." The NCCN panel also stated that in vitro chemosensitivity testing is choose a chemotherapy regimen for recurrent disease should not be recommended due to lack of demonstrated efficacy. Such IHC panels include but are not limited to the following biomarkers for specific drugs:
ALK for crixotinib, penetrexed

Androgen receptor (AR) for goserelin, leuprolide, gonadorelin, flutamide, bicalutamide, abiraterone;

Androgen receptor for bicalutamide, flutamide, abiraterone and enzalutamide;

AREG for cetuximab, panitumumab

BRAF for venurafenib and dabrafenib

BRCA1 for cisplatin, carboplatin

cKIT for sorafenib, sunitinib, imatinib

cMET for erlotinib, gefitinib

EGFR for gefitinib, panitumumab, erlotinib, cetuximab, FOLFIRIEGFRVIII

EGFRvIII, GNA11, GNAQ, IDH2 – for clinical trials

ER and PR for tamoxifen, gefitinib, toremifene, fulvestrant, letrozole, anastrozole, exemestrane, megestrol acetate, erlotinib, panitumumab, medroxyprogesterone;

ERCC1 for oxaliplatin, cisplatin, carboplatin, CAPOX, FOLFOX

EREG for cetuximab, panitumumab

Her2 (ErbB2), PGP and TOP2A (topoisomerase IIA) for doxorubincin, liposomal-doxorubicin, epirubicin;

Her2 or labatinib; epirubicin, pertuzumab, trastuzumab, liposomal doxorubicin, doxorubicin,

KRAS for panitumumab, cetruximab, gefitinib, erlotinib, sorafenib

MGMT for temozolomide and dacarbazine

MRP1 for vinorelbine, vincrisxtine, doxorfubicin, epirubicin, vinblastine, methotrexate

NRAS for cetuximab, panitumumab

PDGFRA for imatinib

PGP (aka MDR1 and ABCB1) for doxorubicin, vincristine, vinblastine, eptoposide, liposomal doxorubicin, paclitaxel , docetaxel, vinorelbine, epirubicin;

PIK3CA for lapatinib, panitumumab, trastuzumab, cetuximab, temsirolimus

PTEN for getitinib, cetuximab, erlotinib, trastuszumab, panitumumab, everolimus, temsirolimus

RET for vandetanib

ROS1 for crizotinib

RRM1 for gemcitabine;

SPARC (monoclonal and polyclonal) for nab-paclitaxel;

TLE3, TUBB3 for docetaxel, paclitaxel;

TOPO1 for irinotecan, topotecan, FOLFIRI;

TS (thymidylate synthase or TYMS) for fluorouracil, capecitabine and pemetrexed


Chemosensitivity profile tumor panels, regardless of whether it is performed by IHC or chromogenic in-situ hybridization (CISH), is not reasonable and necessary for the reasons cited above, and is not a Medicare covered service.

Note, some of these markers are legitimate biomarkers for specified drugs when performed by mutation analysis or FISH testing.

IHC for Cervical/Gyn/Bladder/Kidney Tumors

A variety of IHC stains have found limited use in cervical, gynecologic, and urologic tumor settings. In unusual cases of cervical dysplasia, markers or surrogate markers for HPV may be useful where the diagnosis on conventional H&E stain cannot be made with certainty. These markers are clearly not reasonable and necessary on all biopsies. Claims data indicate combinations of gram stain, PAS, Ki-67, p16 and ProExC stains on all cervical biopsies from select pathology practices, and combinations of p53, Ki-67, CD20 and CD44 on bladder biopsies from select pathology practices.

Similarly, it is rare to need stains to prove that an endometrial or ovarian cancer is a serous cancer or that a kidney neoplasm is an oncocytoma or an eosinophilic or chromophobic renal cell cancer. The use of IHC stains in these circumstances requires adequate documentation in the pathology report, such as “Because the differential histologic diagnosis is between an endometrioid carcinoma and a serous carcinoma, I performed an xxx stain. The controls worked appropriately and the results were positive indicating the tumor is a yyy.”

IHC for Skin & Cutaneous/Soft Tissue/CNS & Peripheral Nervous System Lesions

It is well recognized that most skin lesions are diagnosed with routine H&E slides. That is the case for most melanomas and other pigmented lesions as well. A minority of skin lesions require immunostains (e.g., atypical fibroxanthomas, Merkel cell lesions, lymphomas). Most common skin lesions (e.g., seborrheic keratosis) do not require IHC stains. Use of IHC morphometric codes for skin lesions is incorrect coding.

Similarly, most soft tissue lesions do not require IHC stains or other “special” stains. Soft tissue masses may require stains (e.g., smooth muscle differentiation in a malignant mass) but the most do not.

Many CNS and peripheral nervous system lesions are readily diagnosed with routine stains. It is unusual for a meningioma to require an IHC. The primary role of IHC for CNS and peripheral nervous system lesions is to differentiate primary from metastatic lesions.

IHC for Bone Marrow Samples

Most bone marrow samples are diagnosed with the use of Wright’s stained smears and the use of H&E stained slides with an iron stain supplementing the battery. The use of IHC stains may assist in the interpretation of cases where flow cytometry (FC) does not fit with the routine slide interpretation, when flow cytometry was not obtained or for the evaluation of cell types that are not detected or significantly underrepresented in FC studies, such as large lymphocytes, plasma cells and Reed-Sternberg cells. IHC stains are generally not needed to confirm the results of FC and cytogenetic studies. When medically indicated, justification for the use of both methods must be stated in the pathology report and billed accordingly.



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.
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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.

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