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Each week, the AUA publishes weekly updates on the latest insurance issues pertaining to urology. This week’s update includes revisions to Aetna’s tumor markers and urinary incontinence medical policies, as well as changes to the Sacral Nerve Stimulation (SNS) and Percutaneous Tibial Nerve Stimulation (PTNS) for Urinary and Fecal Incontinence; Urinary Retention medical policy that affects Amerigroup, Anthem, BCBS Georgia, BlueChoice HealthPlan of South Carolina, Community Connect Health Plan, Empire BCBS, Healthlink, and Unicare. AmeriHealth has updated its medical policies for Experimental/Investigational Services CPT/HCPCS Codes, Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia, and Telehealth Services. Furthermore, BCBS Rhode Island has added the drug Jevtana to its Prior Authorization (PA) list, Dean Health Plan and Premera updated their medical policies related to Genetic Testing for Hereditary Cancer Susceptibility, and Envolve Pharmacy Solutions has updated PA criteria for the drugs Eligard, Lupaneta Pack, Lupron Depot, and Lupron Depot-PED. Excellus and Univera Healthcare have added Erleada, Xtandi, Yonsa, and Zytiga to their list of drugs requiring PA, Humana has updated its policy related to Gene Expression Profiling, and Independent Health has updated PA criteria for the drug Xtandi. Nebraska Blue has released a draft policy concerning Adjustable Balloon Continence Devices, NC Medicaid has reviewed and updated its Extracorporeal Shock Wave Lithotripsy and Medically Necessary Circumcision medical policies, and United Healthcare West has updated its surgical code list. Finally, Wellmark has updated its requirements to prove medical necessity for Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy. Please see below for further information about each update.

Aetna

Tumor Markers: This policy was reviewed and updated with the following changes:

• Aetna considers the Mi-Prostate Score (MiPS) for detection of prostate cancer (Mi-Prostate Score (MiPS), an assay of TMPRSS2:ERG (T2:ERG) gene fusion, post-DRE urine expression of PCA3, and serum PSA (KLK3)) test to be experimental and investigational. The peer reviewed medical literature does not support these tests as having sufficient sensitivity or specificity necessary to define their clinical role.

Read the complete update.

Urinary Incontinence: This policy was reviewed and updated with the following changes to criteria, coding, and supporting information:

• Added that FemiLift (CO2 laser) for the treatment of urinary incontinence is considered experimental and investigational because its effectiveness has not been established.
• Removed cancer as an exclusion for the use of InterStim Continence Control Therapy/Sacral Nerve Stimulation.

Read the complete update.

Amerigroup Real Solutions, Anthem, BCBS Georgia, BlueChoice HealthPlan of South Carolina, Community Connect Health Plan, Empire BCBS, Healthlink, Unicare

Sacral Nerve Stimulation (SNS) and Percutaneous Tibial Nerve Stimulation (PTNS) for Urinary and Fecal Incontinence; Urinary Retention: This policy was reviewed and updated with the following additions to coding and supporting information:

• 0587T - Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

• 0588T - Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve

• 0589T - Electronic analysis with simple programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 1-3 parameters

• 0590T - Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 4 or more parameters

Read the complete update.

AmeriHealth, Independence Blue Cross

Experimental/Investigational Services CPT/HCPCS Codes: This policy has been reviewed and updated with the following changes to the effective date and coding that became effective January 27, 2020:

The following codes have been added:

• 31647 - Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe

• 31651 - Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure[s])

The following code has been removed:

• 53854 - Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy
  

AmeriHealth, Independence Blue Cross

Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia: This policy has been reviewed and updated with the following changes to coding:

• The HCPCS code C2596 - Probe, image-guided, robotic, waterjet ablation was added.

• The HCPCS code C9747 - Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance was changed from experimental to experimental/investigational.

Read the complete update.

Telehealth Services: This policy has been reviewed and updated with the following changes to criteria, coding, and supporting information:

• Added that telehealth services for the purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke are not subject to the location criteria.
• Revised policy statement to specify that the policy does not describe telehealth services that are provided by a telemedicine vendor.
• Updated originating site criteria, changing independent renal dialysis facilities from ineligible to eligible.
• The he following eligible originating sites have been added:
  • Home of beneficiaries with end-stage renal disease receiving home dialysis
  • Home of individuals receiving treatment for a substance use disorder or a co-occurring mental health disorder
  • Mobile Stroke Units
• Removed coverage statement for asynchronous, store and forward telemedicine.
• The following codes have been added (note: this is not a complete list of codes added to this policy):
  • 90785 - Interactive complexity (list separately in addition to the code for primary procedure)
  • 90792 - Psychiatric diagnostic evaluation with medical services
  •  90832 - Psychotherapy, 30 minutes with patient
  • 90951 - End-stage renal disease (ESRD) related services monthly, for patients younger than 2 years of age to include monitoring for the adequacy of nutrition, assessment of growth and development, and counseling of parents; with 4 or more face-to-face visits by a physician or other qualified health care professional per month
  • 96116 - Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, eg, acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities), per hour of the psychologist's or physician's time, both face-to-face time with the patient and time interpreting test results and preparing the report
  • 96150 - Health and behavior assessment (eg, health-focused clinical interview, behavioral observations, psychophysiological monitoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment
  • 96160 - Administration of patient-focused health risk assessment instrument (eg, health hazard appraisal) with scoring and documentation, per standardized instrument
  • 97802 - Medical nutrition therapy; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes
  • 99201 - Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: a problem focused history; a problem focused examination; straightforward medical decision making. counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. usually, the presenting problem(s) are self limited or minor. typically, 10 minutes are spent face-to-face with the patient and/or family.
  • 99307 - Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: a problem focused interval history; a problem focused examination; straightforward medical decision making. counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. usually, the patient is stable, recovering, or improving. typically, 10 minutes are spent at the bedside and on the patient's facility floor or unit.
  • G0108 - Diabetes outpatient self-management training services, individual, per 30 minutes
  • G0459 - Inpatient telehealth pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy
  • G0506 - Comprehensive assessment of and care planning for patients requiring chronic care management services (list separately in addition to primary monthly care management service)
• The following codes have been removed (note: this is not a complete list of codes added to this policy):
  • 99446 - Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review
  • 99452 - Interprofessional telephone/Internet/electronic health record referral service(s) provided by a treating/requesting physician or other qualified health care professional, 30 minutes
  • G0459 - Inpatient telehealth pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy
    

BCBS Rhode Island

Prior Authorization of Drugs: The prostate cancer drug Jevtana (J9043) has been added to the list of drugs that require prior authorization. Jevtana is included in a list of Injectable Oncology drugs and lists the recommended dosage at 20 mg/m² administered as a one-hour intravenous infusion every three weeks for the treatment of metastatic castrate-resistant prostate cancer.
Read the complete update.

Dean Health Plan, Prevea360

Genetic Testing for Hereditary Cancer Susceptibility: This policy has been reviewed and updated with the following additions to coding:

• 0012M - Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma

• 0013M - Oncology (urothelial), mRNA, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma

Read the complete update.

Envolve Pharmacy Solutions

Eligard, Lupaneta Pack, Lupron Depot, Lupron Depot-PED: It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that leuprolide acetate injection, Eligard, Lupaneta Pack, Lupron Depot, and Lupron Depot-Ped are medically necessary when the following criteria are met:

• Prostate Cancer (must meet all):
  • Diagnosis of prostate cancer;
  • Request is for leuprolide acetate injection (generic), Eligard, or Lupron Depot (7.5 mg, 22.5 mg, 30 mg, or 45 mg);
  • Prescribed by or in consultation with an oncologist or urologist;
  • Age ≥ 18 years;
  • Request meets one of the following (a, b, or c):*
    • Leuprolide acetate injection (SC): Dose does not exceed 1 mg per day;
    • Eligard (SC)/Lupron Depot (IM): Dose does not exceed 7.5 mg per month, 22.5 mg per 3 months, 30 mg per 4 months, 45 mg per 6 months;
    • Dose is supported by practice guidelines or peer reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval duration: 12 months

*Prescribed regimen must be FDA-approved or recommended by NCCN

Read the complete update.

Excellus, Univera Healthcare

Oncology Clinical Review Rx Drugs – Prior Authorization (PA) Criteria: This policy has been reviewed and updated with the following changes to criteria:

Erleada

• Must be prescribed by a urologist or oncologist AND
• Must be ≥ 18 years of age AND
• Must have a diagnosis of non-metastatic, castration-resistant prostate cancer
  • Must have had serious side effects with Nubeqa AND
  • If patient has not had a bilateral orchiectomy, must also use an LHRH agonist or antagonist in combination OR
• Must have a diagnosis of metastatic, castration-sensitive prostate cancer
  • Must have had serious side effects or drug failure with abiraterone acetate 250 mg AND
  • If patient has not had a bilateral orchiectomy, must also use an LHRH agonist or antagonist in combination
• Recommended dosing is 240mg (four 60mg tablets) administered orally once daily
• Quantity limit of 120/30 days

Xtandi

• Must be prescribed by a urologist or oncologist AND
  • Must be ≥ 18 years of age AND
  • Must have a diagnosis of metastatic castration-resistant prostate cancer
    • Must have had serious side effects or drug failure with abiraterone acetate 250mg – UNLESS pt has visceral metastases (liver, lung, adrenal, peritoneal, and brain mets; soft tissue/lymph node sites are not considered visceral mets) AND
      • Used in combination with LHRH agonist or antagonist OR
    • Must have a diagnosis of non-metastatic castration-resistant prostate cancer
      • Must have had serious side effects with Nubeqa AND
      • Used in combination with LHRH agonist or antagonist OR
    • Must have a diagnosis of metastatic castration-sensitive prostate cancer
      • Must have had serious side effects or drug failure with abiraterone acetate 250mg AND
      • Used in combination with LHRH agonist or antagonist – unless patient has had orchiectomy, can then be used as single agent
    • Approval will be for 1 year at a time. Continuation of therapy will not be approved if there is evidence of disease progression or unacceptable toxicity.
    • Xtandi will not be approved in patients who have a history of seizure or have predisposing factors for seizure because safety and efficacy in these patients has not been established.
    • Quantity limit of 120/30 days.
    • Please note: for applicable lines of businesses (Commercial, Exchange, Child Health Plus), a split-fill program will apply to new starts only. An override to bypass the split-fill program will be provided for existing users that have been maintained on Xtandi

Yonsa

• Must be prescribed by a urologist or oncologist AND
• Must have had serious side effects with abiraterone acetate 250mg AND
• Must have a diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
  • Must be used in combination with methylprednisolone OR
• The safety of Yonsa in patients with LVEF<50% or NYHA Class III or IV heart failure has not been established and therefore will not be approved.
  • Recommended dosage is 500mg (four 125mg tablets) administered once daily in combination with methylprednisolone 4mg administered orally twice daily
  • Patients with moderate base line hepatic impairment (Child-Pugh Class B) should be started at a reduced dose of 125mg once daily. Dose should be increased to 500mg twice a day for patients on CYP3A4 inducers for the co-administration period. Reduce dose back to the previous dose and frequency once concomitant strong CYP3A4 inducer is discontinued
  • Quantity limit of 120/30days. A QL of 240/30 days will be allowed if documentation is received that a strong CYP3A4 inducer must be co-administered
  • Please note: for applicable lines of businesses (Commercial, Exchange, Child Health Plus), a split-fill program will apply to new starts only. An override to bypass the split-fill program will be provided for existing users that have been maintained on Yonsa

Zytiga

• Must be prescribed by a urologist or oncologist AND
• Must be ≥ 18 years of age AND
• Requests for brand Zytiga must have had serious side effects with abiraterone acetate 250mg AND
• Must have a diagnosis of metastatic castration-resistant prostate cancer (mCRPC) OR a diagnosis of metastatic high-risk castration-sensitive prostate cancer (mCSPC)
  • Must be used in combination with prednisone or methylprednisolone and an LHRH agonist or antagonist
• The safety of Zytiga in patients with LVEF<50% or NYHA Class III or IV heart failure has not been established and therefore will not be approved.
• Patients with moderate base line hepatic impairment (Child-Pugh Class B) should be started at a reduced dose of 250mg once daily
• Quantity limit of 120/30days for 250mg tablet, 60/30 days for 500mg tablet
• Please note: for applicable lines of businesses (Commercial, Exchange, Child Health Plus), a split-fill program will apply to new starts only. An override to bypass the split-fill program will be provided for existing users that have been maintained on Zytiga

Read the complete update.

Humana

Gene Expression Profiling: This policy has been reviewed and updated with the following addition to CPT coding:

• 81542 - Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score.

Please note: this is a non-covered procedure.

Independent Health

Xtandi PA Criteria: This policy has been reviewed and updated with the following changes to criteria, dosing, coding, and supporting information:

• Removed initial approval criterion for prostate cancer stating that the member has previously tried and failed treatment with Zytiga.
• Revised renewal approval criterion stating that disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread to change “tumor response” to “disease response” and specify treatment is defined by the treatments.
• Added 160 mg per day to dosing limits for medical benefit max units.
• Removed the following HCPCS code:
  • C9399 - Unclassified drugs or biologicals (Hospital Outpatient Use Only)

Read the complete update.

Nebraska Blue

Adjustable Balloon Continence Devices: Nebraska Blue has released a draft policy stating that permanent adjustable balloon continence devices are considered investigational and not covered for all indications. The Permanent Adjustable Balloon Continence Devices (e.g. ACT and ProACT therapy system) for females and males are considered Investigational for the treatment of urinary incontinence because its effectiveness has not been established.

Read the complete update.

North Carolina Medicaid

Extracorporeal Shock Wave Lithotripsy: This policy has been reviewed and updated with changes to criteria:

• General Criteria - Medicaid and NCHC shall cover the procedure, product, or service related to this policy when medically necessary, and:
  • the procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the beneficiary’s needs;
  • the procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide; and
  • the procedure, product, or service is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.
• Specific Criteria Covered - Medicaid and NCHC cover ESWL as follows:
  • for the disintegration of upper urinary tract stones in the kidney and the ureter above the true pelvis.
  • for renal calyx stones, renal pelvic stones, or upper ureteral stones only.
  • Other treatments modalities such as percutaneous lithotripsy, dissolution therapy, or conventional surgery may be used in conjunction with ESWL.

Read the complete update.

North Carolina Medicaid

Medically Necessary Circumcision: General criteria - Medicaid and NCHC shall cover the procedure, product, or service related to this policy when medically necessary, and:

• the procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the beneficiary’s needs;
• the procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide; and the procedure, product, or service is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.

Specific Criteria - Specific criteria covered by both Medicaid and NCHC

• Medically Necessary Circumcision for Non-Newborns: Medicaid and NCHC cover circumcision for beneficiaries beyond the newborn period only when the procedure is medically necessary. Examples of medical necessity for non-newborn circumcision include, but are not limited to, the following conditions:
  • Young males with a documented prior history of recurrent urinary tract infections.
  • Males with documented vesicoureteral reflux of at least a Grade III.
• Paraphimosis.
• Recurrent balanoposthitis.
• True phimosis causing urinary obstruction, hematuria or preputial pain for beneficiaries ages 6 and older. True phimosis is defined as pathological scarring of the tip of the prepuce preventing sufficient retraction of the prepuce to visualize the meatus and does not include congenital or acquired preputial adhesions to the glans proximal to the meatus.
• Secondary or acquired phimosis causing urinary obstruction, hematuria or preputial pain unresponsive to medical therapy.
• Condyloma acuminatum.
• Malignant neoplasm of the prepuce.

Lysis or Excision of Penile Post-Circumcision Adhesions: Medicaid and NCHC cover lysis or excision of penile post-circumcision adhesions when medically necessary.

• Refer to Attachment A, Section C for the specific CPT code when adhesions are severe enough to require anesthesia or analgesia stronger than topical analgesia and an instrumented release under sterile conditions.
• Refer to Attachment A, Section C for the specific CPT code if adhesions require only foreskin manipulation, including lysis of preputial adhesions and stretching.

Repair of Incomplete Circumcision: Medicaid and NCHC cover the repair of incomplete circumcision when excessive residual prepuce remains after a previous medically necessary circumcision.

Medicaid Additional Criteria Covered

• Medically Necessary Circumcision for Newborns: Medicaid covers medically necessary circumcision for newborns. The conditions justifying medical necessity are extremely rare (i.e., certain congenital obstructive urinary tract anomalies, neurogenic bladder, spina bifida, or urinary tract infections) and are subject to individual review.

Note: “Newborn” is interpreted as the first 28 days of life.

Read the complete update.

United Healthcare West

Surgical Code List: UHC West has updated its surgical code list to include C2596 – Probe image guided robotic waterjet ablation. This was not the only surgical code added to the list. Please review the complete update for a full list of surgical codes.

Read the complete update.

Wellmark

Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: Stereotactic radiosurgery (SRS) using a gamma ray or linear accelerator or Stereotactic Body Radiotherapy (SBRT) may be considered medically necessary for the following indications:

• Arteriovenous malformations;
• Acoustic neuromas;
• Pituitary adenomas;
• Nonresectable, residual, or recurrent meningiomas;
• Craniopharyngiomas;
• Glomus jugulare tumors;
• Solitary or multiple brain metastases in patients having good performance status and no active systemic disease;
• Primary malignancies of the central nervous system (CNS), including, but not limited to, high-grade gliomas (initial treatment or treatment of recurrence);
• Trigeminal neuralgia refractory to medical management;
• Base of skull chordomas and chondrosarcomas;
• ligometastases involving lung, adrenal glands and/or, bone
• Patients with stage T1 or T2a non-small-cell lung cancer (not >5 cm) showing no nodal or distant disease and who are not candidates for surgical resection;
• Spinal or vertebral body tumors (metastatic or primary) in patients who have received prior radiotherapy.
• Spinal or vertebral metastases that are radioresistant (eg, renal cell carcinoma, melanoma, sarcoma).
• Primary head and neck stage IV tumor (Any N1, M0, M1 and G) with limited tumor bulk amenable to local therapy
• Hepatocellular Carcinoma, and secondary metastasis to the liver that is considered unresectable
• Pancreatic Cancer without invasion of bowel or stomach
• Kidney Cancer in the following clinical scenario:
  • Relapse or Stage IV and
  • Unresectable and
  • Symptomatic Metastases
• Cervical cancer in isolated metastatic sites only

• For prostate cancer when all of the following criteria (1-4) are all met:

• Low grade prostate cancer defined by a Gleason score less than or equal to 6 and prostate-specific antigen (PSA) less than 10 ng/mL; and

• Minimal disease defined as less than four cores positive; and

  • No evidence of extra prostatic disease; and
  • Life expectancy of greater than 10 years.

Read the complete update.