Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Prostate Mapping Biopsy
Policy #:MA11.016a

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Prostate mapping biopsy is considered medically necessary and, therefore, covered for the following indications:
  • Men who are at high-risk for prostate cancer and who have had at least one or more (commonly two) conventional transrectal office-based biopsies of the prostate
  • Men at high risk for prostate cancer despite negative biopsies include rising PSA with a PSA velocity of > 1.5 ng/mL; and either
    • Intermediate histological findings on the first or second biopsy (such as atypia or prostatic intraepithelial neoplasia)
    • Persistent, or worsening suspicious digital rectal exam
  • Men who have a low level Gleason score, i.e., 6 or 3+3, and who are contemplating an Active Surveillance Program to ensure the need for an upgrade to the Gleason score.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, prostate mapping biopsy is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

Prostate mapping is performed after an initial diagnosis of prostate cancer when a prior needle biopsy has been performed. If a previous biopsy has not indicated prostate cancer, then a more extensive biopsy method is needed to rule out prostate cancer. It is also used if a traditional biopsy has revealed prostate cancer and the patient has elected focused treatment.

Saturation biopsy using prostate mapping is performed under general anesthesia to identify the exact location of each biopsy core. Each core (typically 20-40) is marked individually to identify the exact location and the extent of the tumor for further treatment of prostate cancer.

The 3D prostate mapping biopsy (PMB) is an ultrasound-guided biopsy procedure that takes the biopsies through the perineum (rather than the rectum as in the usual TRUS biopsy) using a brachytherapy grid system. The biopsies are taken every 5 millimeters throughout the gland, and each sample is labeled as to its location on the grid. When the results of the biopsy are reported, the grid overlay on a saved ultrasound of the prostate reveals the exact location of the cancer. 3D PM can effectively direct subsequent focal cryoablation and exclude patients with significant multifocal disease.

Active surveillance is a type of approach often used to monitor the cancer closely with prostate-specific antigen (PSA) blood tests, digital rectal exams (DREs), and ultrasounds at regular intervals to see if the cancer is growing. Prostate biopsies may be done as well to see if the cancer is becoming more aggressive. If there is a change in test results, the primary care provider then discusses treatment options.
References

American Cancer Society. Expectant management (watchful waiting) and active surveillance for prostate cancer. [ACS Web site]. March 2016. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-treating-watchful-waiting Accessed May 07, 2019.

Novitas, Inc. Local Coverage Determination (LCD). L35009 Prostate Mapping Biopsy. [Novitas, Inc. Web site]. Original 10/01/2015. Revised 10/01/2016. Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35009&ver=9&Keyword=prostate+mapping+biopsy&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAAAA%3d%3d&. Accessed May 07, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

55706


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY


C61 Malignant neoplasm of prostate

R97.21 Rising PSA following treatment for malignant neoplasm of prostate


For the indication of high risk prostate cancer, despite negative biopsies, the ICD-10-CM diagnosis code R97.20 must also be billed with an additional ICD-10-CM diagnosis code.

R97.20 Elevated prostate specific antigen [PSA]

ADDITIONAL CODES TO SUPPORT MEDICAL NECESSITY

N40.2 Nodular prostate without lower urinary tract symptoms

N40.3 Nodular prostate with lower urinary tract symptoms

R89.7 Abnormal histological findings in specimens from other organs, systems and tissues



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.016a
06/05/2019The policy has been reviewed and updated to communicate the Company’s continuing position for Prostate Mapping Biopsy.
07/03/2018Effective 07/03/2018, this policy has been reviewed and updated to communicate the Company’s continuing position for Prostate Mapping Biopsy.
09/27/2017The policy has been reviewed and updated to communicate the Company’s continuing position for Prostate Mapping Biopsy.
10/01/2016The following ICD-10 Diagnosis code has been deleted from this policy: R97.2
The following ICD-10 Diagnosis codes have been added to this policy: R97.20, R97.21

MA11.016
07/06/2016This policy has been reviewed and reissued to communicate the Company's continuing position for Prostate Mapping Biopsy.
08/19/2015This policy has been reviewed and reissued to communicate the Company's continuing position for Prostate Mapping Biopsy. ICD 10 codes have been added.
01/01/2015This is a new policy.




Version Effective Date: 10/01/2016
Version Issued Date: 10/01/2016
Version Reissued Date: 06/05/2019