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August 2021

Billing chart: Blues highlight medical, benefit policy changes

You’ll find the latest information about procedure codes and Blue Cross Blue Shield of Michigan billing guidelines in the following chart.

This billing chart is organized numerically by procedure code. Newly approved procedures will appear under the New Payable Procedures heading. Procedures for which we have changed a billing guideline or added a new payable group will appear under Updates to Payable Procedures. Procedures for which we are clarifying our guidelines will appear under Policy Clarifications. New procedures that are not covered will appear under Experimental Procedures.

You will also see that descriptions for the codes are no longer included. This is a result of recent negotiations with the AMA on use of the codes.

We will publish information about new BCBS groups or changes to group benefits under the Group Benefit Changes heading.

For more detailed descriptions of the BCBSM policies for these procedures, please check under the Medical/Payment Policy tab in Explainer on web-DENIS. To access this online information:

  • Log in to web-DENIS.
  • Click on BCBSM Provider Publications & Resources.
  • Click on Benefit Policy for a Code.
  • Click on Topic.
  • Under Topic Criteria, click on the drop-down arrow next to Choose Identifier Type and then click on HCPCS Code.
  • Enter the procedure code.
  • Click on Finish.
  • Click on Search.
Code* BCBSM changes to:
Basic Benefit and Medical Policy, Group
Variations Payment Policy, Guidelines
NEW PAYABLE PROCEDURES

33940, 33944, 33945, 47135, 47140, 47141, 47142, 47143, 47144, 47145, 47146, 47147

Basic benefit and medical policy

Combined heart‑liver transplantation

The safety and effectiveness of a combined heart‑liver transplant have been established. It may be considered a useful therapeutic option for carefully selected patients with end-stage heart and liver disease.

This policy is effective July 1, 2021.

Inclusionary and exclusionary guidelines:

Combined heart-liver transplants are established when transplantation of a single organ is precluded by severe disease in the other organ system, such that the patient’s prognosis after combined transplantation is felt to be better than sequential transplantation.

Inclusions:

Indications for heart‑liver transplantation include, but aren’t limited to, end stage heart and liver diseases that aren’t amenable to any other form of therapy such as:

  • Familial amyloidosis
  • Heart failure with associated cardiac cirrhosis
  • Familial hypercholesterolemia
  • Hereditary hemochromatosis
  • Homozygous B‑thalassemia
  • End-stage cardiac disease as indicated in related heart transplant policy
  • End-stage liver disease as indicated in related liver transplant policy

Exclusions:

  • Significant systemic or multisystemic disease (other than heart and liver failure)
  • Active alcohol or other substance abuse that interferes with compliance to the strict treatment regimen needed following transplant
  • Malignancies metastasized to or extending beyond the margins of the heart and/or liver

Potential contraindications for transplant or retransplant

Note: Final patient eligibility for transplant is subject to the judgment and discretion of the requesting transplant center.

Potential contraindications represent situations where proceeding with transplant isn’t advisable in the context of limited organ availability. Contraindications may evolve over time as transplant experience grows in the medical community. Clinical documentation supplied to the health plan should demonstrate that attending staff at the transplant center have considered all contraindications as part of their overall evaluation of potential organ transplant recipients and have decided to proceed.

  • Known current malignancy or history of recent malignancy
  • Untreated systemic infection making immunosuppression unsafe, including chronic infection
  • Other irreversible end-stage disease not attributed to heart or kidney disease
  • Systemic disease that could be exacerbated by immunosuppression
  • Psychosocial conditions or chemical dependency affecting ability to adhere to therapy as defined by the transplant program

All transplants must receive prior authorization through the Human Organ Transplant Program.

44799,** 45399**

**Used to report a not otherwise classified service

Basic benefit and medical policy

Double balloon enteroscopy

The safety and effectiveness of double balloon enteroscopy have been established. It may be considered a useful therapeutic or diagnostic option when indicated.

Inclusions:

  • Evaluation and treatment/therapeutic interventions for patients with obscure or occult gastrointestinal bleeding or suspected small bowel pathology, when esophagogastroduodenoscopy and capsule endoscopy have failed to provide a diagnosis (or if capsule endoscopy is contraindicated).
  • A positive finding on capsule endoscopy requiring a biopsy or therapeutic intervention
  • For the removal of entrapped foreign bodies in the small bowel (e.g., retained video capsule)
  • For use in conjunction with endoscopic retrograde cholangiopancreatography, or ERCP, in individuals with surgically altered upper GI anatomy
  • For evaluation of the colon in the case of or history of incomplete colonoscopy
UPDATES TO PAYABLE PROCEDURES

J3490

J3590

Basic benefit and medical policy

Cabenuva (cabotegravir + rilpivirine)

Cabenuva (cabotegravir + rilpivirine) is payable for its FDA‑approved indications when billed with procedure code J3490 or J3590, effective Jan. 22, 2021. Cabenuva (cabotegravir + rilpivirine) should be reported with procedure code J3490 or J3590 and the appropriate national drug code until a permanent code is established.

URMBT groups are excluded from coverage of this drug. 

Cabenuva (cabotegravir + rilpivirine) is a two‑drug co-packaged product of cabotegravir, a human immunodeficiency virus type‑1 integrase strand transfer inhibitor, or INSTI, and rilpivirine, an HIV‑1 non‑nucleoside reverse transcriptase inhibitor, or NNRTI, is indicated as a complete regimen for the treatment of HIV‑1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV‑1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Dosage and administration:
Before initiating treatment with Cabenuva, oral lead‑in dosing should be used for approximately one month to assess the tolerability of cabotegravir and rilpivirine.

  • For intramuscular gluteal injection only.
  • Recommended dosing schedule: Initiate injections of Cabenuva (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of oral lead‑in and continue with injections of Cabenuva (400 mg of cabotegravir and 600 mg of rilpivirine) every month thereafter.

Dosage forms and strengths:
Cabotegravir extended-release injectable suspension and rilpivirine extended release injectable suspension, co‑packaged as follows:

Cabenuva 400 mg/600 mg kit:

  • Single‑dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir
  • Single‑dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine

Cabenuva 600 mg/900 mg kit:

  • Single‑dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir
  • Single‑dose vial of 900 mg/3 mL (300 mg/mL) rilpivirine

Q2041

Basic benefit and medical policy

Yescarta (axicabtagene ciloleucel)

Yescarta (axicabtagene ciloleucel), procedure code Q2041, is approved for its new FDA indication, effective March 10, 2021.

Indications have been updated to include treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
POLICY CLARIFICATIONS

0174T, 0175T, 71250, G0296

Basic benefit and medical policy

Screening for lung cancer using computed tomography scanning or chest radiographs

The safety and effectiveness of low‑dose CT scanning of the lung as a screening tool for lung cancer have been established. It’s a useful therapeutic option for patients meeting patient selection guidelines.

Routine chest radiographs, including computer‑aided detection, or CAD, analysis of the X‑ray, for the purpose of screening patients for lung cancer is experimental. They haven’t been shown to improve long-term patient clinical outcomes.

Inclusionary criteria have been updated, effective July 1, 2021.

Inclusions:

Low‑dose CT scanning, no more frequently than annually, may be appropriate as a screening technique for lung cancer in individuals who meet all the following criteria, which are based on the results of the National Lung Screening Trial, or NLST:

  • Between 50 and 80 years of age
  • History of cigarette smoking of at least 20 pack‑years (A “pack-year” is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. One pack year is the equivalent of 365.24 packs of cigarettes or 7,305 cigarettes.)
  • Currently smokes or has quit within the past 15 years

Screening should be discontinued once a person hasn’t smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.

Exclusions:

  • Low‑dose CT scanning as a screening technique for lung cancer in all other situations where the above selection guidelines aren’t met
  • Routine chest radiographs when used as a screening technique for ruling out lung cancer

43644, 43645, 43770, 43771, 43772, 43773, 43774, 43775, 43843, 43845, 43846, 43847, 43848, 43886, 43887,
43888, 43999, 44130, 96130, 96131, 96136, 96137, 96138, 96139, S2083

Not covered:
43842, 43999,** 96146

**When used to indicate any of the following procedures:

  • Loop gastric bypass gastroplasty - also known as mini-gastric bypass
  • Stomach stapling
  • SADI‑S
  • SIPS
  • Endoscopic procedures to treat weight gain after bariatric surgery
  • Natural Orifice Transluminal Endoscopic Surgery (NOTES™)

Basic benefit and medical policy

Bariatric surgery

The safety and effectiveness of laparoscopic and open gastric restrictive procedures, including, but not limited to, gastric-band, Roux-en-Y, gastric bypass, sleeve gastrectomy and biliopancreatic diversion have been established. They may be considered useful therapeutic options when specified criteria are met.
 
Criteria surrounding the six-month period of a supervised weight-loss program have been removed, effective July 1, 2021.

Inclusions:

The surgical procedures for severe obesity, including sleeve gastrectomy, are considered established treatment options if all the following criteria are met:

  • The patient has a BMI >40 or a BMI of >35 with one or more co‑morbid conditions, including, but not limited to:
    • Degenerative joint disease (including degenerative disc disease)
    • Hypertension
    • Hyperlipidemia, coronary artery disease
    • Presence of other atherosclerotic diseases
    • Type 2 diabetes mellitus
    • Sleep apnea
    • Congestive heart failure 
  • All patients 18 to 60 years of age with conditions above. 
  • Patients above age 60 may be considered if it’s documented in the medical record that the patient’s physiologic age and co‑morbid conditions result in a positive risk/benefit ratio.
  • Criteria for bariatric surgery for patients younger than 18 years of age are similar: 1. BMI ≥40 kg/m2 (or 140% of the 95th percentile for age and sex, whichever is lower); 2. BMI ≥35 kg/m2 (or 120% of the 95th percentile for age and sex, whichever is lower) with clinically significant comorbidities, and should include documentation that the primary care provider has addressed the risk of surgery on future growth, the patient’s maturity level and the patient’s ability to understand the procedure and comply with postoperative instructions, as well as the adequacy of family support.
  • The patient has undergone multidisciplinary evaluation by an established bariatric treatment program to include medical, nutritional and mental health evaluations to determine ultimate candidacy for bariatric surgery. Such an evaluation should include an assessment of the patient’s likely ability and willingness to cooperate effectively with a rigorous post‑operative program. This should include documentation of past participation in a non‑surgical weight loss program. 
  • The non‑surgical program participation and multidisciplinary evaluation must have occurred within four years of the date of surgery. 
  • A psychological evaluation must be performed as a pre-surgical assessment by a contracted mental health professional to establish the patient’s emotional stability, ability to comprehend the risk of surgery and to give informed consent, and ability to cope with expected post‑surgical lifestyle changes and limitations. Such psychological consultations may include a total of one unit of psychological testing for purposes of personality assessment (e.g., the MMPI‑2 or adolescent version, the MMPI‑A).
  • In cases where a revision of the original procedure is planned because of failure due to anatomic or technical reasons (e.g., obstruction, staple dehiscence, etc.), or excessive weight loss of 20% or more below ideal body weight, the revision is determined to be medically appropriate without consideration of the initial preoperative criteria. The medical records should include documentation of:
    • The date and type of the previous procedure
    • The factors that precipitated the failure or the nature of the complications from the previous procedure that mandate (necessitate) the takedown
  • If the indication for the revision is a weight gain or a failure of the patient to lose a desired amount of weight due to patient non‑adherence, then the patient must re‑qualify for the subsequent procedure and meet all of the initial preoperative criteria.

Exclusions:

The following surgical procedures are considered experimental because their safety or effectiveness haven’t been proven:

  • Loop gastric bypass gastroplasty using a Billroth II type of anastomosis, also known as mini gastric bypass
  • Biliopancreatic bypass without duodenal switch
  • Long‑limb gastric bypass procedure (i.e., >150 cm)
  • Stomach stapling (vertical banded gastroplasty)
  • Endoscopic/endoluminal procedures, including, but not limited to, insertion of the StomaphyX™ device, insertion of a gastric balloon, endoscopic gastroplasty or use of an endoscopically placed duodenojejunal sleeve) as a primary bariatric procedure or as a revision procedure, (e.g., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches).
  • Any bariatric surgery for patients with Type 2 diabetes who have a BMI of less than 35
  • Laparoscopic gastric plication
  • Vagus nerve blocking (See separate policy, “Vagus Nerve Blocking for Morbid Obesity.”)
  • Single anastomosis duodenoileal bypass with sleeve gastrectomy (SADI‑S)
  • Stomach intestine pylorus sparing, or SIPS, surgery
  • Bariatric surgery for pre-adolescents
  • Intragastric balloons
  • Aspiration therapy device
  • Natural Orifice Transluminal Endoscopic Surgery, or NOTES™

Established:
81519, 81520, 81521, 84999*

Experimental:
S3854, 0045U, 0153U, 81518, 81522, 84999**

**Used to report a not otherwise classified service. Only established when used for Oncotype 70 gene panel test.

Basic benefit and medical policy

Gene expression profiling for prognosis of breast cancer

The safety and effectiveness of the use of the 21‑gene reverse transcriptase-polymerase chain reaction (RT‑PCR) assay (i.e., Oncotype DX®, the EndoPredict®, the Breast Cancer Index℠, MammaPrint and Prosigna™ tests) to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy have been established. They are useful diagnostic tests for determining the likelihood of distant cancer recurrence in women for patients who meet the inclusionary guidelines.

The use of the 21‑gene reverse transcriptase‑polymerase chain reaction assay (e.g., Oncotype DX, the EndoPredict, the Breast Cancer Index, MammaPrint and Prosigna tests, this isn’t an all‑inclusive list) to determine hormonal therapy after five years is considered experimental.

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

Exclusionary criteria have been updated, effective July 1, 2021.

Inclusions (must meet all):

The use of Oncotype Dx, the EndoPredict, the Breast Cancer Index, MammaPrint and Prosigna tests to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy may be considered established in women with breast cancer meeting all the following characteristics:

  • Unilateral tumor
  • Hormone receptor‑positive (that is, 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/poor differentiation or unfavorable features or tumor size larger than 1 cm
  • Node negative (lymph nodes with micrometastases [less than 2 mm in size] are considered node negative for this policy).
  • Who will be treated with adjuvant endocrine therapy, i.e., tamoxifen or aromatase inhibitors
  • When the test result will aid the patient in making the decision regarding chemotherapy (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

Use of multigene assay to assess prognosis and determine chemotherapy benefit for node‑positive, ER+, HER2‑ breast cancer with pN1mi (≤2 mm axillary node metastasis) or N1 (<4 nodes) is established.

These tests should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria. For instance, the test shouldn’t be ordered on a preliminary core biopsy. The test should be ordered in the context of a physician‑patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who otherwise meet the above characteristics but who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histological characteristics should be submitted for testing. It’s not necessary to conduct testing on each tumor; treatment is based on the most aggressive lesion.

Exclusions:

  • Gene expression assays when used in tandem with other similar assays is considered experimental, only a single assay should be used (i.e., Oncotype DX and MammaPrint shouldn’t be ordered on the same patient).
  • Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ, or DCIS, (i.e., Oncotype DX® DCIS) to inform treatment planning following excisional surgery 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 chemotherapy in women with triple-negative breast cancer is considered experimental.

95782, 95783, 95800, 95805, 95806, 95807, 95808, 95810, 95811, E0486, G0398, G0399 

Not covered:

95801, A7047, E0485, E1399, G0400

Basic benefit and medical policy

Diagnosis of sleep disorders

The exclusionary criteria for the use of home sleep studies to diagnose obstructive sleep apnea have been updated, effective July 1, 2021.

Exclusions:

Due to the length of the complete policy guidelines, only the updates are included here. Below are the changes that were made to the diagnosis section regarding unattended (unsupervised) home sleep studies.

Exclusions and contraindications:

  • Younger than 18 years of age
  • Morbid obesity, defined as a body mass index >40 kg/m2 or the patient is 100 pounds over the ideal body weight for his or her height
  • Obesity hypoventilation syndrome
  • Narcolepsy
  • Periodic limb disorder during sleep
  • Central sleep disorder
  • Parasomnias
  • Nocturnal seizures
  • REM behavior disorder
  • Moderate or severe congestive heart failure ‑ New York Heart Association class III or IV
  • Congestive heart failure with a history of ventricular fibrillation or sustained ventricular tachycardia in a patient who doesn’t have an implanted defibrillator
  • Moderate or severe chronic pulmonary disease ‑ forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) less than or equal to 0.7 and FEV1 less than 80% of predicted
  • Documented neuromuscular disease (e.g., Parkinson’s, myotonic dystrophy, ALS)
  • History of stroke, severe insomnia or chronic opioid use
  • Impairment that results in inability to apply the home sleep testing equipment
  • Oxygen dependence

Please reference the medical policy for complete coverage guidelines on other services related to the diagnosis and management of obstructive sleep apnea.

96000, 96001, 96002, 96003, 96004

Basic benefit and medical policy

Comprehensive gait analysis

The safety and effectiveness of comprehensive gait analysis (the use of sophisticated quantitative and video capture devices) have been established. It may be considered a useful diagnostic option in specified situations.

Inclusionary and exclusionary criteria have been updated, effective July 1, 2021.

Inclusions:

Comprehensive gait analysis is considered established when used:

  • As an aid in surgical planning in patients with gait disorders associated with cerebral palsy

Exclusions:

  • Gait analysis that doesn’t meet definition of comprehensive
  • Gait analysis that is used for purposes other than surgical planning for individuals with cerebral palsy, including but not limited to:
    • Gait disorders associated with conditions other than cerebral palsy (e.g., club foot)
    • Postoperative evaluation of surgical outcomes
    • Evaluation or planning for rehabilitation for any reason

E0787, S1034, S1035, S1036, S1037

Basic benefit and medical policy

Artificial pancreas device system

The safety and effectiveness of a U.S. Food and Drug Administration‑approved artificial pancreas device systems with a low glucose suspend feature and hybrid closed loop systems may be considered established in patients with insulin‑requiring diabetes who meet specified patient selection criteria. It’s a useful therapeutic option for selected patients.

Inclusionary criteria have been updated, effective July 1, 2021.

Inclusions:

Use of FDA‑approved artificial pancreas device systems with a low‑glucose suspend feature may be considered established in patients with insulin‑requiring diabetes who meet all the following criteria:

  • Age 6 or older
  • Insulin requiring diabetes
  • Individuals with demonstrated hypoglycemia unawareness

Use of an FDA‑approved automated insulin delivery system (artificial pancreas device system) designated as hybrid closed‑loop insulin delivery system (with low glucose suspend and suspend before low features) is considered established in patients with insulin requiring diabetes who meet all the following criteria:

  • Age 6 and older
  • Insulin requiring diabetes
  • Individuals with demonstrated hypoglycemia unawareness

or

  • Age 2 to 6 years and:
    • Clinical diagnosis of Type 1 diabetes for three months or more
    • Used insulin pump therapy for more than three months
    • Glycated hemoglobin level <10.0%
    • Minimum daily insulin requirement (total daily dose) of greater than or equal to 8 units

Exclusions:

  • Use of an artificial pancreas device system is considered experimental in all other situations.
  • Use of an artificial pancreas device system not approved by the FDA is experimental.

Experimental
E0830, E0941, E1399**

**Used to report a not otherwise classified service

Basic benefit and medical policy

Lumbar traction devices for treatment of low back pain

The use of mechanical, autotraction, gravity‑dependent (axial spinal unloading) and pneumatic lumbar traction devices are experimental in any setting. These devices haven’t been scientifically demonstrated to be safe and effective for the treatment of low back pain, herniated disc or other indications and haven’t been shown to improve patient outcomes.

Exclusionary criteria have been updated, effective July 1, 2021.

Exclusions:

Non-established lumbar traction devices include, but aren’t limited to:

  • Pneumatic lumbar traction devices (e.g., Saunders Lumbar HomeTrac, Saunders STx, Orthotrac Pneumatic Vest)
  • Autotraction devices (e.g., the Spinalator Spinalign massage intersegmental traction table, the Arthrotonic stabilizer, the Quantum 400 intersegmental traction table and the Anatomotor)
  • Axial spinal unloading (gravity‑dependent traction) devices (e.g., LTX 3000, Triton DTS, Z‑Grav Spinal Decompression Table)
  • Conventional lumbar traction using a pelvic harness attached to pulleys and weights, now considered to be obsolete
  • Mechanical traction devices (e.g., Chattanooga New Lumbar Home Traction, Saunders Lumbar Hometrac and the Enshey Traction Bed)
  • Pettibon System (i.e., spine and posture correction and muscular development, therapeutic wobble chair, lumbar traction devices, weighting system)
  • Lumbar lordotic curve‑controlled traction devices (e.g., Kinetrac‑9900)

J0180

Basic benefit and medical policy

Fabrazyme (agalsidase beta)

Effective March 11, 2021, Fabrazyme (agalsidase beta) is covered for the following FDA‑approved indications: 

Fabrazyme is a hydrolytic lysosomal neutral glycosphingolipid‑specific enzyme indicated for the treatment of adult and pediatric patients age 2 years and older with confirmed Fabry disease.

J1599

Basic benefit and medical policy

Panzyga (immune globulin intravenous, human‑ifas)

Effective Feb. 18, 2021, Panzyga (immune globulin intravenous, human‑ifas) is covered for the following updated FDA‑approved indication:

  • Chronic inflammatory demyelinating polyneuropathy, or CIDP, in adults

Dosage and administration:

Indication: CIDP in adults

Dose ‑ loading dose: 2 g/kg (20 mL/kg), divided into two daily doses of 1 g/kg (10 mL/kg) given on two consecutive days

Maintenance dose: 1‑2 g/kg (10‑20 mL/kg) every three weeks divided in two doses given over two consecutive days
 
Initial infusion rate: 1 mg/kg/min (0.01 mL/kg/min)

Maximum infusion rate (as tolerated): 12 mg/kg/min (0.12 mL/kg/min)

J2547

Basic benefit and medical policy

Rapivab (peramivir)

Effective Jan. 28, 2021, Rapivab (peramivir) is covered for the following updated FDA‑approved indication:

Rapivab (peramivir) is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than two days.

Dosage and administration:

  • Administer Rapivab as a single dose within two days of onset of influenza symptoms.
  • Administer Rapivab by intravenous infusion for a minimum of 15 minutes.

Recommended dosage:

Adults and adolescents 13 years and older, single dose: 600 mg

Pediatric patients 6 months to 12 years, single dose: 12 mg/kg (up to 600 mg)

Recommended dosage adjustments in patients with altered creatinine clearance

Adults and adolescents, 13 years and older:

  • Creatinine clearance (mL/min) ≥ 50: 600 mg
  • Creatinine clearance (mL/min) 30‑49: 200 mg
  • Creatinine clearance (mL/min) 10‑29: 100 mg

Pediatric patients,** 2 to 12 years of age:

  • Creatinine Clearance (mL/min) ≥ 50: 12 mg/kg
  • Creatinine Clearance (mL/min) 30‑49: 4 mg/kg
  • Creatinine Clearance (mL/min) 10‑29: 2 mg/kg

**Up to maximum dose of 600 mg

Note: No recommendation for dosage adjustment can be made for pediatric patients 6 months to less than 2 years with creatinine clearance less than 50 mL/min.

J3490

J3590

Basic benefit and medical policy

Nulibry (fosdenopterin)

Effective Feb. 26, 2021, Nulibry (fosdenopterin) is covered for the following FDA‑approved indication:

Nulibry (fosdenopterin) is cyclic pyranopterin monophosphate, or cPMP, indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency, or MoCD, Type A.

J3490

J3590

Basic benefit and medical policy

Restylane Defyne (hyaluronic acid)

Restylane Defyne (hyaluronic acid) is considered experimental for the following indications:

  • Mid to deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in adults older than 21 years
  • The augmentation and correction of mild to moderate chin retrusion for adults older than 21 years.

The service isn’t payable for these indications. This change is effective Feb. 1, 2021.

J9119

Basic benefit and medical policy

Libtayo (cemiplimab‑rwlc)

Effective Feb. 9, 2021, Libtayo (cemiplimab‑rwlc) is covered for the following updated FDA‑approved indications:

Basal cell carcinoma, or BCC

  • For the treatment of patients with locally advanced BCC (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
  • For the treatment of patients with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate**

**The mBCC indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for mBCC may be contingent upon verification and description of clinical benefit.

Non‑small cell lung cancer, or NSCLC

  • For the first‑line treatment of patients with NSCLC whose tumors have high PD‑L1 expression (Tumor Proportion Score, or TPS, ≥ 50%) as determined by an FDA‑approved test, with no EGFR, ALK or ROS1 aberrations and are locally advanced where patients aren’t candidates for surgical resection or definitive chemoradiation or metastatic

Dosage and administration:
 
The recommended dosage of Libtayo is 350 mg as an intravenous infusion over 30 minutes every three weeks. 

Dosage forms and strengths:

Injection: 350 mg/7 mL (50 mg/mL) solution in a single‑dose vial.

J9144

Basic benefit and medical policy

Darzalex Faspro (daratumumab and hyaluronidase‑fihj)

Effective Jan. 11, 2021, Darzalex Faspro (daratumumab and hyaluronidase‑fihj) is covered for the following updated FDA‑approved indications:

  • Multiple myeloma in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.
  • Light chain amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients. This indication is approved under accelerated approval, based on response rate.
EXPERIMENTAL PROCEDURES

30468, 30999**

**Used to report a not otherwise classified service

Basic benefit and medical policy

Absorbable nasal implants

The insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse is considered experimental. The positive impact on clinical outcomes hasn’t been definitively demonstrated, effective July 1, 2021.

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*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2020 American Medical Association. All rights reserved.