Billing chart: Blue Cross highlights medical, benefit policy changes

81518, 81522   

Other established codes:
81519, 81520, 81521, 81523

Experimental codes:
S3854,** 0045U, 0153U, 81599,***
84999***

**Used to represent any gene panel test that isn’t in the established code section

Basic benefit and medical policy

Genetic testing to determine breast cancer prognosis

The safety and effectiveness of reverse-transcriptase polymerase chain reaction, or RT-PCR, assays (e.g., Oncotype DX^®, EndoPredict^®, Breast Cancer Index^®, MammaPrint^® and Prosigna^®) for determining whether to undergo adjuvant chemotherapy may be considered established. They are useful diagnostic tests for predicting the likelihood of early cancer recurrence (0 to 5 years) in individuals who meet the inclusionary guidelines.

The safety and effectiveness of Breast Cancer Index^® for prognosis of late (years 5 to 10) distant recurrence to determine extended adjuvant endocrine therapy may be considered established.

The use of other assays (e.g, Oncotype DX^®, EndoPredict^®, Breast Cancer Index^®, MammaPrint^® and Prosigna^®; this is not an all-inclusive list) to determine prognosis of late (years 5 to 10) distant recurrence to determine extended endocrine therapy is considered experimental.

Other genetic testing for determining the likelihood of distant cancer recurrence in women is experimental (refer to policy exclusions).

Inclusionary criteria have been updated, effective Sept. 1, 2022.

Payment policy:

• Not payable in an office location
• Modifiers 26 and TC not applicable

Inclusions:

Testing for recurrence risk and adjuvant chemotherapy

Node-negative breast cancer

Inclusions (must meet all):

The use of Oncotype Dx^®, EndoPredict^®, Breast Cancer Index^®, MammaPrint^® and Prosigna^® tests to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered established in women with node-negative breast cancer meeting all the following characteristics:

• Unilateral tumor
• Hormone receptor-positive (i.e., estrogen-receptor, or ER, positive or progesterone-receptor, or PR, -positive)
• Human epidermal growth factor receptor, or HER, 2-negative
• Tumor size 0.6-1 cm with moderate or poor differentiation or unfavorable features or tumor size larger than 1 cm
• Node negative (lymph nodes with micrometastases [less than 2 mm in size]  considered node negative for this policy)
• Who will be treated with adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors)
• When the test result will aid the patient in making the decision regarding chemotherapy (i.e., when chemotherapy is a therapeutic option).
• When ordered within six months after diagnosis, since the value of the test for making decisions regarding delayed chemotherapy is unknown

Or

For N1 (less than four nodes)

Inclusions:

The use of Oncotype Dx^®, EndoPredict^®, Breast Cancer Index^®, MammaPrint^® and Prosigna^® tests to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered established in women with N1 breast cancer meeting all the following criteria:

• Hormone receptor-positive (i.e., estrogen-receptor positive)
• Human epidermal growth factor receptor 2-negative
• Node positive (lymph nodes with micrometastases [more than 2 mm in size]) (pN1mi)

Or
N1 (< 4 nodes) and

• When ordered within 6 months after diagnosis

Extended endocrine therapy

Inclusions:

The Breast Cancer Index^® test may be considered established to predict the benefit of extended (5 to 10 years) adjuvant endocrine therapy in women who are recurrence-free at five years.

Exclusions:

• Use of more than one gene expression assay for determining recurrence risk for deciding whether to undergo adjuvant chemotherapy (e.g., Oncotype Dx and MammaPrint for the same individual to help determine if adjuvant chemotherapy would be beneficial)
• Use of assays (e.g., Oncotype DX DCIS, DCISionRT^® [this list is not all-inclusive]) in women who have ductal carcinoma in situ for decision-making regarding radiotherapy is considered experimental.
• The use of other gene expression assays (e.g., Mammostrat^® Breast Cancer Test, the BreastOncPx™, NexCourse^® Breast IHC4, BreastPRS™, etc.) for any indication is experimental.
• The use of gene expression assays in men with breast cancer is considered experimental.
• The use of gene expression assays to molecularly subclassify breast cancer (e.g., BluePrint^®) is considered experimental.
• The use of gene expression assays for quantitative assessment of ER, PR and HER2 overexpression (e.g., TargetPrint^®) is considered experimental.
• The use of Insight TNBCtype™ to aid in making decisions regarding neoadjuvant chemotherapy in women with triple-negative breast cancer is considered investigational.

Updates to the policy effective Nov. 1, 2022:

The italicized bullets in the exclusions section above were removed, as the tests are no longer available.

The following information regarding MammaPrint^® was added:

MammaPrint^®

The use of the MammaPrint assay to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive breast cancer meeting all of following characteristics:

• Unilateral tumor
• Hormone receptor-positive (i.e., estrogen receptor-positive or progesterone receptor-positive)
• Human epidermal growth factor receptor 2-negative
• Stage T1 or T2 or operable T3 at high clinical risk**
• 1 to 3 positive nodes
• Who’ll be treated with adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors)
• When the test result aids the patient in deciding on chemotherapy (i.e., when chemotherapy is a therapeutic option)
• When ordered within six months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.

**High risk:

• Grade: Well differentiated; tumor size, 2.1 cm to 5 cm
• Grade: Moderately differentiated; tumor size, any size
• Grade: Poorly differentiated or undifferentiated; tumor size, any size

31647, 31648, 31649, 31651

Basic benefit and medical policy

Bronchial valves

The insertion of endobronchial valves is established in adult patients with respiratory compromise from hyperinflation associated with severe heterogenous lung emphysema with little to no collateral ventilation.

The insertion of endobronchial valves is established for persistent bronchopleural air leak causing pneumothorax that isn’t improving five or more days after chest tube insertion. 

Exclusionary criteria have been updated, effective Nov. 1, 2022.         

Inclusions:

This procedure should be performed at a facility with the ability to admit. Admission should be based on perceived risks or complications.

Criteria for pleural air leak:

Bronchopleural air leak not improving five or more days after chest tube placement when site of air leak can be identified by balloon occlusion of the distal affected bronchus

Criteria for emphysema:

Respiratory insufficiency caused by bullous emphysema in a patient found after multidisciplinary evaluation not to be a candidate for lung volume reduction surgery

Inclusions:

• Ex-smokers
• Pulmonary function test:
• Post bronchodilator forced expiratory volume at 1 second 15 to 45%
• Total lung capacity ≥100%
• Right ventricular ≥175%

• Arterial blood gas with pCO2 <60
• Completed pulmonary rehabilitation program or enrolled in a pulmonary rehabilitation program of at least six to eight sessions or attestation from physician that the patient has received adequate pulmonary rehabilitation to proceed with surgery
• CT imaging confirming intact fissure between lobes

Exclusions:

• Any general contraindications to bronchoscopy or general anesthesia
• Lung findings:
• Pulmonary nodule requiring work up
• Giant bullae (>1/3 hemithorax)
• Cardiovascular event (e.g., myocardial infarction or heart failure) in the prior six months
• Recent cerebral vascular accident/stroke (three months)
• Evidence of uncontrolled pulmonary hypertension with systolic PAP >45 mmHg on transthoracic echocardiography

33340

Basic benefit and medical policy

Percutaneous LAA closure devices for stroke prevention

The safety and effectiveness of an FDA-approved percutaneous left atrial appendage closure device (e.g., Watchman™ Left Atrial Appendage Closure, Watchman FLX, Amplatzer™ Amulet™) for the prevention of stroke in patients with atrial fibrillation have been established. It may be considered a therapeutic option when indicated.

Coverage criteria have been updated, effective Nov. 1, 2022.

Inclusions:

FDA-approved percutaneous left atrial appendage closure devices are considered established when both the following criteria are met.

• There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc score and systemic. anticoagulation therapy is recommended
• The long-term risks of systemic anticoagulation outweigh the risks of the device implantation.

Policy guidelines:

The balance of risks and benefits associated with percutaneous implantation of an FDA-approved percutaneous LAAC device for stroke prevention (e.g., Watchman or Amplatzer Amulet), as an alternative to systemic anticoagulation, must be made on an individual basis.

Bleeding is the primary risk associated with systemic anticoagulation. A number of risk scores have been developed to estimate the risk of significant bleeding in patients treated with systemic anticoagulation. An example is the HAS-BLED score, which is validated to assess the annual risk of significant bleeding in patients with atrial fibrillation treated with warfarin. Scores range from 0 to 9, based on a number of clinical characteristics (see Table PG1).

Table PG1. Clinical Components of the HAS-BLED Bleeding Risk Score

Adapted from Pisters et al (2010) HAS-BLED: Hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR (international normalized ratio), elderly, drugs/alcohol concomitantly.

The risk of major bleeding in patients with scores of 3, 4 and 5 has been reported at 3.74 per 100 patient-years, 8.70 per 100 patient-years, and 12.5 per 100 patient-years, respectively. Scores of 3 or greater are considered to be associated with a high risk of bleeding, potentially signaling the need for closer monitoring of patients for adverse events, closer monitoring of international normalized ratio or differential dose selections of oral anticoagulants or aspirin.

Exclusions:

The use of a device with FDA approval for percutaneous left atrial appendage closure (e.g., the Watchman™, Watchman FLX, Amplatzer™ Amulet™) for stroke prevention in patients who don’t meet the above criteria is considered experimental.

The use of devices not approved by the FDA for percutaneous left atrial appendage closure (including but not limited to the Lariat Loop Applicator and Amplatzer Cardiac Plug devices) for stroke prevention in patients with atrial fibrillation is considered experimental.

93784, 93786, 93788, 93790

Basic benefit and medical policy

Ambulatory blood pressure monitoring

Ambulatory blood pressure monitoring is established as safe and effective and is a useful option when performed for the screening, diagnosis and management of hypertension when indicated.

Inclusionary and exclusionary criteria have been updated, effective Nov. 1, 2022.

Inclusions and exclusions:

Ambulatory blood pressure monitoring is established in any of the following circumstances:

• To screen for the presence of hypertension in pediatric and adult patients consistent with nationally accepted protocols (e.g., USPSTF)
• To confirm the diagnosis of hypertension before initiating pharmacotherapy when the diagnosis is uncertain
• When the information obtained by ambulatory blood pressure monitoring is necessary to determine the adequacy of antihypertensive management

Ambulatory blood pressure monitoring should be used to support clinical decision-making. ABPM isn’t medically necessary if clinical decision-making can be accomplished with the use of traditional methods of blood pressure measurement alone. The medical record should reflect the need and rationale for use of ABPM.

For pediatric patients, the principles of ABPM used to confirm a diagnosis of hypertension are the same as in adults, but there are special considerations as follows:

• A device should be selected that is appropriate for use in pediatric patients, including use of a cuff size appropriate to the child’s size.
• Threshold levels for the diagnosis of hypertension should be based on pediatric normative data, which use gender- and height-specific values derived from large pediatric populations.
• Recommendations from the American Heart Association concerning classification of hypertension in pediatric patients using clinic and ambulatory BP are given below:

Classification of ambulatory blood pressure levels in children and adolescents

Clinic systolic or diastolic blood pressure

<13 years of age:

• Normal BP: <95th percentile
• White coat hypertension: ≥95th percentile
• Masked hypertension: <95th percentile
• Ambulatory hypertension: ≥95th percentile

≥13 years of age:

• Normal BP: <130/80 mm Hg
• White coat hypertension: ≥130/80
• Masked hypertension: <130/80
• Ambulatory hypertension: ≥130/80

Mean ambulatory systolic or diastolic blood pressure

<13 years of age:

• Normal BP: <95th percentile or adolescent cut points^a
• White coat hypertension: <95th percentile or adolescent cut points^a
• Masked hypertension: ≥95th percentile or adolescent cut points^a
• Ambulatory hypertension: ≥95th percentile or adolescent cut points^a

≥13 years of age:

• Normal BP: <125/75 mm Hg over 24-h and <130/80 mm Hg while awake and <110/65 mm Hg while asleep
• White coat hypertension: <125/75 mm Hg over 24-h and <130/80 mm Hg while awake and <110/65 mm Hg while asleep
• Masked hypertension: ≥125/75 mm Hg over 24-h or ≥130/80 mm Hg while awake or ≥110/65 mm Hg while asleep
• Ambulatory hypertension: ≥125/75 mm Hg over 24-h or ≥130/80 mm Hg while awake or ≥110/65 mm Hg while asleep

^aIncluding 24 h, wake, and sleep blood pressure.
Note: Adapted from Flynn et al. (2022).

J9271

Basic benefit and medical policy

Keytruda (pembrolizumab)

Effective Feb. 4, 2022, Keytruda (pembrolizumab) is no longer payable for the following usage related to gastric cancer as a single agent for the treatment of patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 (Combined Positive Score ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

S9123, S9124

Basic benefit and medical policy

Private duty nursing

Private duty nursing may be considered established when specified criteria are met (refer to inclusions and exclusions).

The coverage guidelines have been updated, effective Nov. 1, 2022.

Payment policy:

This policy doesn’t address benefit, reimbursement or prior authorization requirements. Please verify member benefits before service.

Inclusions:

• The member must have a need for skilled nursing care. The services are for the skilled needs of the member and not the family or caregiver or solely for respite purposes. Custodial care doesn’t qualify for PDN. The services are to be provided in the member’s home.
• The member must have a medically complex and or medically fragile condition that requires continuous assessments, observation and monitoring for 24 hours a day. Skilled nursing services need not be provided for 24 hours to meet this criterion. The need for such services is required to meet this criterion. The patient must be medically stable at the time of discharge from the hospital such that PDN services can be provided safely. The member’s need for skilled nursing exceeds that found in the Home Health Care benefit.
• At least eight hours of PDN per day are required to meet the needs of the patient.
• At least two caregivers (family, friend, etc.) must be trained and competent to give care when the nurse isn’t in attendance.
• The family or caregivers must provide at least eight hours of skilled care per day.
• The PDN services must be ordered by a physician, M.D. or D.O. who is involved in the ongoing care of the patient.

Specific clinical criteria (all must be met):

• Continuous assessment, observation and monitoring of a complex and or fragile clinical condition. Hourly documentation of the clinical information and services performed is required.
• Training and teaching activities by the skilled nurse to teach the patient, family or caregivers how to manage the treatment regimen is required and considered a skilled nursing service. Training is no longer appropriate if after a reasonable period of time the member, family or caregiver won’t or isn’t able to be trained. If the caregiver or family member can’t or won’t accept responsibility for the care, private duty nursing will be considered not medically necessary as the home would be deemed an unsafe environment.
• Criteria and documentation requirements for specific conditions, if present, in addition to the medically complex and or fragile condition of the patient:
• Tracheostomy tube suctioning is necessary for secretion control and required at least twice per eight-hour shift. (Tracheostomy tube changing is skilled; tracheostomy hygiene care isn’t.)
• Ventilator management recording initial settings of mode of ventilation, tidal volume, respiratory rate and wave form modifications, if any, (PEEP) and FIO2 at the beginning of the shift. Oxygen saturation must be measured continuously for ventilator patients and any changes from baseline recorded thereafter. Hourly observations of the patient’s clinical condition related to the ventilator management must be documented along with any changes in oxygen saturation.
• Management of tube drainage, complex wounds, cavities, irrigations require documentation of services on the record when they occur.
• Complex medication administration (excluding PO medications that would ordinarily be taken by self-administration) of drugs with potential for serious side effects or drug interactions require documentation and appropriate monitoring. This includes intravenous administration of drugs or nutrition.
• Tube feedings that require frequent changes in formulation or administration rate or have conditions that increase the aspiration risk requires documentation.

PDN for patients on ventilators:

• The PDN benefit is not a 24/7 or lifetime benefit. For members who are on ventilators after discharge or suffer an acute event, up to 30 days of PDN services can be used to transition members to the home or stabilized the member after an acute event. The goal is to transition care to family members or caregivers once the member is stable. Once the member is stable and family members or caregivers can provide routine ventilator care or wean (when appropriate) the member under the direction of their health care professional, ventilator management isn’t considered a skilled service requiring home nursing.

Exclusions:

Services of a private duty nurse are considered not covered in the following instances:

• The PDN is acting as a nurse’s aide.
• The primary duties are limited to bathing, feeding, exercising, homemaking, giving oral medications or acting as companion or sitter.
• The PDN is a member of your household or the care is provided by one of your relatives (by blood, marriage or adoption).
• It’s for maintenance care after the condition has stabilized (including routine ostomy care or tube feeding administration) or if the anticipated need is indefinite:
• Medical and nursing documentation shows that the member’s condition is stable, predictable, controlled, and a licensed nurse isn’t required to monitor the condition.
• Care plan indicates a licensed nurse isn’t required to be in continuous attendance.
• Care plan doesn’t require hands-on nursing interventions. (Note: Observation in case an intervention is required isn’t considered skilled care.)
• The care is for a person without an available caregiver in the home (24-hour private duty nursing isn’t covered).
• It’s for respite care (e.g., care during a caregiver vacation), the convenience of the family caregiver or so that the caregiver may attend work or school, or care for other family members.
• The caregiver or patients have demonstrated the ability to carry out the plan of care.
• The PDN is provided outside the home (e.g., school, nursing facility or assisted living facility).
• It’s a duplication or overlap of services (e.g., when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit).
• It’s for observational purposes only.
• The skilled nursing is provided as part time or intermittent and not continuous care.