Blogs

Each week, the AUA publishes weekly updates on the latest insurance issues pertaining to urology. This week’s update includes new policies from AlohaCare and UPMC, revisions to current policies from Aetna, AmeriHealth, BCBS North Carolina, BlueAdvantage, Horizon, and HealthNet, and updates in Prior Authorization (PA) criteria from ArchCare, BCBS Minnesota, Highmark, Premera, and Tufts Health Plan. Also, there are two Local Coverage Articles (LCAs) from WPS Government Health Administrators. Please see below for additional details on each policy update.

Aetna

Aetna has reviewed and updated its ablative procedures for prostate cancer medical policy with the following changes to criteria and supporting information:

• Added the following to the list of experimental and investigational ablative procedures:

  • Dual-fiber laser ablation
  • Photothermal ablation with copper sulfide nanoplates

Read the complete update.

AlohaCare

AlohaCare has created a new medical policy to address provider-preventable conditions. The procedure is as follows:

• AlohaCare monitors provider billing to identify and disallow payment for medical care that is needed solely to treat a Provider Preventable Condition (PPC). This includes any item on the CMS list of Health Care Acquired Conditions as of the date of service that occur in an inpatient setting, and Other Provider Preventable Conditions which occur in any healthcare setting.
• When a condition is present on admission, or at the time the provision of health care is initiated to that patient by that provider, it is not considered a PPC for purposes of that encounter. The claim should include a present on Admission (POA) modifier for any HCAC or OPPC that was present prior to initiation of care of the specific patient by the specific provider.
• When a claim is submitted with the knowledge that it includes charged for a PPC, the appropriate modifier must be included on the claim. No payment will be made for the portion of the claim that can be isolated which is directly related to treatment for the PPC.
• AlohaCare will monitor all claims for the inclusion of services directly related to treatment for, and related to, the PPC. This includes prepayment and post payment methodology.
• When a claim for a service directly related to treatment for a PPC is identified prior to payment for that claim, the amount of the payment will be reduced by that amount.
• When a claim for a service directly related to treatment for a PPC is identified after the claim has been paid, the amount of the payment will be recouped by AlohaCare.

AmeriHealth, Independence Blue Cross

AmeriHealth has reviewed and updated its gonadotropin-releasing hormone agonist pharmacy policy with the following changes to criteria, coding, and supporting information:

• Added a Medicare local coverage determination statement that Leuprolide acetate, 3.75 mg (HCPCS J1950) and Leuprolide acetate, 7.5 mg (HCPCS J9217) are covered when the following criteria are met:
  • Leuprolide acetate, 3.75 mg (HCPCS J1950) represents Lupron Depot and will only be
    covered for non-oncologic diagnoses as described in this policy.
  • Although Lupron Depot (leuprolide acetate) has been approved by the US FDA for prostate cancer and Compendia supports the use of Lupron Depot for certain cancers, Eligard (leuprolide acetate) is considered to be the lower-cost alternative.
  • Leuprolide acetate, 7.5 mg (HCPCS J9217) represents Eligard and Lupron Depot will be
    covered for both oncologic and non-oncologic diagnoses as described in this policy.
• Added criteria for head and neck cancers, specifically salivary gland tumors, stating that leuprolide acetate for injection is considered medically necessary and therefore covered for the treatment of androgen-receptor positive recurrent disease with distant metastases in individuals with a performance status of 0-3.
• Revised criteria for invasive breast cancer, changing language for endocrine therapy to “recurrent or stage IV (M1) disease.”
• Revised criteria for ovarian cancer in the following way:
  • Added the specifying phrase “clinical relapse” to the criterion on epithelial ovarian, fallopian tube, and primary peritoneal cancers.
  • Specified that it is used as a single agent for clinical relapse in individuals with stage II-IV granulosa cell tumors.
• Revised criteria for prostate cancer extensively, including, but not limited to, the following:
  • Added criteria for adjuvant androgen deprivation treatment if lymph node metastasis found during pelvic lymph node dissection in the following cases:
    • In the favorable or unfavorable intermediate risk group and greater than or equal to 10 year expected survival.
    • In the high or very high risk groups and greater than 5 year expected survival.
  • Added criteria for ADT as a single agent or in combination with a first-generation antiandrogen for M0 Prostate-Specific Antigen persistence/recurrence:
    • After radical prostatectomy in combination with EBRT if studies negative for distant metastatic disease.
    • Positive digital rectal examination after EBRT if biopsy negative and studies negative for distant metastatic disease.
    • Positive DRE after EBRT in individuals who are not candidates for local therapy (especially if bone scan positive).
  • Added indication of castration-naive disease.
  • Added indication of M0 or M1 castration-resistant disease.

Read the complete update.

ArchCare

ArchCare has updated its master PA Criteria that applies to PACE Medicaid-Medicare Dual Eligible beneficiaries for the prostate cancer drug Nubeqa with the following changes to criteria:

• Prior Authorization Group: Nubeqa
• Drug Name: Nubeqa
• Covered Uses: All FDA-approved indications not otherwise excluded from Part D
• Coverage Duration: Plan Year

Read the complete update.

BCBS Minnesota

BCBS Minnesota has published PA criteria for self-administered oncology agents for Medicaid beneficiaries. Target Agent(s) will be approved when ALL of the following are met:

• ONE of the following:
  • Information has been provided that indicates the patient is currently being treated with the requested agent OR
  • The prescriber states the patient is being treated with the requested agent AND is at risk if therapy is changed OR
  • ALL of the following:
    • ONE of the following:
      • The patient has an FDA approved indication for the requested agent OR
      • The patient has an indication that is supported by compendia for the requested agent. (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1,IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) [i.e., this indication must be supported by ALL requirements in the compendia (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy, etc.)] for the requested agent or the prescriber has submitted additional documentation supporting the requested therapeutic use (approval by the Clinical Review Pharmacist required) AND
    • ONE of the following:
      • ALL of the following:
        • The requested indication requires genetic/specific diagnostic testing per FDA labeling or compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested agent AND
        • Genetic/specific diagnostic testing has been completed AND
        • The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate OR
      • The requested indication does NOT require genetic/specific diagnostic testing per FDA labeling or supported by compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested agent AND
        • ONE of the following:
          • The requested agent is approved for use as monotherapy in the FDA labeling or compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested indication OR
          • The requested agent will be used with all agent(s) and/or treatments (e.g., radiation) listed for concomitant use in the FDA labeling or compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested indication AND
        • ONE of the following:
          • The requested agent is FDA labeled or supported by compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) as a first-line agent for the requested indication OR
          • The patient has tried and had an inadequate response to the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling or compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested indication OR
          • The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling or compendia (NCCN 1, 2A, or 2B recommended use, AHFS, DrugDex level of evidence of 1, IIa, or IIb, Wolters Kluwer Lexi-Drugs level of evidence A, Clinical Pharmacology) for the requested indication AND
        • The patient does not have any FDA labeled contraindications to the requested agent AND
        • The patient does not have any FDA labeled limitation(s) of use that is otherwise not supported in National Comprehensive Cancer Network (NCCN) to the requested agent AND
        • ONE of the following:
          • Quantity limit does NOT apply to the requested agent OR
          • The requested quantity (dose) does NOT exceed the program quantity limit OR
            • ALL of the following:
              • The requested quantity (dose) is greater than the program quantity limit AND
              • The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
              • The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
            • ALL of the following:
              • The requested quantity (dose) is greater than the program quantity limit AND
              • The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
              • The prescriber has submitted information in support of therapy with a higher dose for the requested indication

Length of Approval: Up to 3 months for dose titration requests over the program quantity limit and Vitrakvi. Up to 12 months for all other requests.

Read the complete update.

BCBS North Carolina

BCBS NC has reviewed and updated its prostatic urethral lift medical policy to reflect the following changes to required criteria and supporting information:

• Revised medical necessity criterion regarding appropriate screening for prostate cancer within the past year; clarified that the testing results should exclude diagnosis of prostate cancer.
• Updated policy guidelines and references sections.
• Reviewed by Specially Matched Consultant Advisory Panel on 11/20/2019.

Read the complete update.

BlueAdvantage Administrators of Arkansas

BlueAdvantage Administrators of Arkansas has reviewed its intensity-modulated radiotherapy of the prostate medical policy for Walmart Associate's Medical Plan beneficiaries to reflect the following changes:

• Intensity-modulated radiotherapy (IMRT) may be considered medically necessary in the treatment of localized prostate cancer.
• IMRT may be considered medically necessary after radical prostatectomy when criteria are met.
• Criteria include the following:
  • Adjuvant therapy when there are adverse pathologic findings at prostatectomy or with a persistently detectable prostate-specific antigen level after prostatectomy
  • Salvage therapy when there is evidence of biochemical or local recurrence when there is no evidence of distant metastatic disease

Read the complete update.

Horizon BCBS New Jersey

Horizon BCBS NJ has updated its gene expression profiling and protein biomarkers for prostate cancer management medical policy to reflect following changes to supporting information:

• Added the following CPT code:

o   81542 Prostate oncology, mRNA, microarray gene expression profiling

• Updated literature review with a search through October 8, 2019; revised rationale section.

Read the complete update.

HealthNet

HealthNet has reviewed and updated its medical policy for the prostate cancer drug Erleada to reflect the following changes to criteria and supporting information:

• Revised initial approval criterion for Erleada for prostate cancer requiring that the member is diagnosed with non-metastatic and castration-resistant prostate cancer (CRPC) with evidence of disease progression despite bilateral orchiectomy or other androgen replacement therapy, adding that the member may be diagnosed with metastatic and castration-sensitive prostate cancer as an alternate requirement.
• Revised initial and continuation approval criteria for Erleada for prostate cancer requiring that the dose does not exceed 240 mg (4 tablets) per day, adding that the dose may be supported by practice guidelines or peer-reviewed literature for the relevant off-label use as an alternate requirement. Added footnote stating that the prescribed regimen must now be FDA-approved or recommended by NCCN.
• Revised continuation approval criterion for Erleada for prostate cancer requiring that the member is responding positively to therapy with no evidence of metastases, adding the specification that the requirement that there is no evidence of metastases is applicable only to members with CRPC.
• Revised FDA-approved indications and general information sections.

Read the complete update.

Highmark Inc.

Highmark Inc. has created PA criteria for the prostate cancer drugs Erleada, Nubeqa, and Xtandi for Pennsylvania and West Virginia Medicare beneficiaries. These drugs may be considered medically necessary when criteria are met.

Criteria include, but are not limited to, the following:

• For Xtandi, the member has a diagnosis of castration-resistant prostate cancer.
• For Erleada, the member has had a bilateral orchiectomy.
• For Nubeqa, the member has a diagnosis of non-metastatic castration-resistant prostate cancer.

Read the complete update.

Premera

Premera has reviewed and updates its Medicare Part D master PA criteria to reflect the following changes to criteria.

• Drug Names: Erleada
• Covered Uses: All medically accepted indications not otherwise excluded from Part D.
• Exclusion Criteria: N/A
• Required Medical Information: The requested drug will be used in combination with a gonadotropin-releasing hormone (GnRH) analog OR after bilateral orchiectomy.
• Age Restrictions: N/A
• Prescriber Restrictions: Prescribed by or in consultation with an oncologist or urologist.
• Coverage Duration: 12 months
• Other Criteria: Approve for continuation of prior therapy.

Read the complete update.

Tufts Health Plan

Tufts Health Plan has reviewed and updated its Medicare preferred PA medical necessity guidelines - master PA criteria to reflect the following changes to criteria for the prostate cancer drug Xtandi:

• Drug Name: Xtandi
• Covered Uses: All FDA-approved indications not otherwise excluded from Part D.
• Exclusion Criteria: None
• Required Medical Information: The member must have a documented diagnosis of castration-resistant prostate cancer
• Age Restrictions: None
• Prescriber Restrictions: The prescribing physician must be an oncologist or urologist.
• Coverage Duration: FDA-approved duration, balance of contract year or clinically appropriate duration
• Other Criteria: None

Read the complete update.

UPMC Health Plan

UPMC Health Plan has created a new medical policy for ostomy supplies. Ostomy supplies may be considered medically necessary when criteria are met.

• Ostomy supplies  are only  medically  necessary for use  on a patient with  a surgically created opening  (stoma)  to divert  urine,  or fecal  contents  outside  the  Ostomy supplies are only appropriately used for colostomies, ileostomies or urinary ostomies. The  quantity  of  ostomy  supplies  needed  by a patient is  determined  primarily  by the type of ostomy,  its  location,  its  construction,  and  the condition  of the skin  surface  surrounding the  stoma. There will be variation according to individual patient need and their needs may vary over time. The  explanation  for use  of a greater  quantity  of supplies  than  the  amounts  listed  must  be clearly  documented  in  the patient’s medical  record. If  adequate  documentation  is  not provided  when  requested,  the excess  quantities  will  be denied  as not reasonable  and medically necessary.
• When a liquid barrier is necessary, either liquid or spray (A4369) or individual wipes or swabs (A5120) are appropriate. The use of both is not reasonable and necessary.
• Patients with  continent  stomas  may  use the  following  means  to prevent/manage drainage:  stoma  cap (A5055), stoma  plug  (A5081), stoma  absorptive  cover  (A5083) or gauze  pads (A6216).
• No more than one of these types of supply would be reasonable and necessary on a given day. Patients with urinary ostomies may use either a bag (A4357) or bottle (A5102) for drainage at night. It is not medically necessary to have both.

Read the complete update.

WPS Government Health Administrators

WPS Government Health Administrators has published a new article for decipher biopsy prostate cancer classifier assay for men with very low and low risk disease to address billing and coding that complement the corresponding Local Coverage Determination (LCD). To report a Decipher^® Prostate Cancer Classifier Assay service, please submit the following claim information:

• Select CPT^® code 81479
• Enter 1 unit of service (UOS)
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
  • Loop 2400 or SV101-7 for the 5010A1 837P
  • Box 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
  • Line SV202-7 for 837I electronic claim
  • Block 80 for the UB04 claim form
• Select ICD-10-CM code C61

Read the complete update.

WPS Government Health Administrators has published a new article for oncotype DX AR-V7 nucleus detect for men with metastatic castrate resistant prostate cancer (MCRPC) (MoIDX) to address billing and coding that complement the corresponding LCD. To report an Oncotype DX AR-V7 Nucleus Detect service, please submit the following claim information:

• Select CPT code 81479
• Enter 1 unit of service (UOS)
• ·         Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
  • Loop 2400 or SV101-7 for the 5010A1 837P
  • Box 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
  • Line SV202-7 for 837I electronic claim
  • Block 80 for the UB04 claim form
• Select the appropriate ICD-10-CM code

Read the complete update.