Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Cryosurgical Ablation of the Prostate Gland
Policy #:MA11.022a

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.

MEDICALLY NECESSARY

Cryosurgical ablation of the prostate gland is considered medically necessary and, therefore, covered for either of the following:
  • As primary treatment for individuals with localized prostate cancer, stages T1-T3
  • As salvage therapy for recurrent prostate cancer for individuals with localized disease, when both of the following criteria are met:
    • Primary treatment with a trial of radiation therapy has failed
    • The individual's test results are consistent with at least one of the following:
      • Stage T2B or below
      • Gleason score less than 9
      • Prostate-specific antigen (PSA) less than 8 ng/mL


EXPERIMENTAL INVESTIGATIONAL

Subtotal prostate cryoablation is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

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

The following list classifies stages of prostate cancer (T1-T3) based on physical examination, pathology, laboratory, or radiology results:

T1Digitally unrecognized tumor
T1ALess than 5 percent of the transurethral resection of the prostate
(TURP) specimen, or low-to-medium grade tumor
T1BGreater than 5 percent of the TURP specimen, or high-grade tumor
T1CTumor detected by elevated prostate-specific antigen (PSA)
T2Digitally palpable tumor confined to the prostate
T2ALess than 1/2 of one lobe
T2B
T2C
Greater than 1/2 of one lobe
Tumors involve both lobes
T3
T3A
T3B
Cancer extending beyond the prostate capsule
Tumor extends outside of the prostate, but not the seminal vesicles
Tumor has spread to the seminal vesicles

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

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cryosurgery of the prostate 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

The prostate is a gland located around the urinary outlet of the bladder in the male body. About the size of a chestnut, the prostate is composed of two side-by-side lobes connected in the front by a narrowed part of the gland and from behind by a middle lobe that lies above and between the ejaculatory ducts. The gland secretes a milky fluid that is discharged by excretory ducts into the prostatic urethra at the time of emission of semen.

Cryosurgical ablation of the prostate (CSAP), also known as cryosurgery of the prostate gland, reduces the size of the prostate gland by using extremely cold temperatures to destroy abnormal prostate tissue. Cryosurgical ablation of the prostate is performed by inserting a probe through an opening in the perineum to apply a freezing agent, such as liquid nitrogen, to the prostate gland and the probe is guided by transrectal ultrasonography.

The procedure modality involves either complete ablation of the prostate or focal ablation (subtotal cryoablation) only targeting diseased tissue while leaving normal tissue intact. In 2017, the American Urological Association, along with the American Society for Radiation Oncology and the Society for Urologic Oncology updated their joint guidelines on the management of clinically localized prostate cancer which included recommendations on focal treatment for low-risk and intermediate risk prostate cancer patients stating that focal therapy is not a standard care option because comparative outcome evidence is lacking. In addition, focal therapy for men with high-risk localized prostate cancer is not recommended outside of a clinical trial.

In 2001, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) indicating that CSAP was medically necessary and appropriate as a primary treatment for patients with clinically localized prostate cancer, Stages T1 - T3. Additionally, salvage CSAP for recurrent cancer was deemed medically necessary and appropriate only for patients with localized disease who have failed a trial of radiation therapy as their primary treatment and have either of the following conditions: Stage T2B or below, a Gleason score less than 9, or a Prostate-specific antigen (PSA) less than 8 ng/mL.
References

American Urolgical Association (AUA). Clinically localized prostate cancer: AUA/ASTRO/SUO Guideline. [AUA Web site]. 2017.Available at: https://www.auanet.org/guidelines/prostate-cancer-clinically-localized-(2017). Accessed May 07, 2019.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 230.9: Cryosurgery of prostate. [CMS Web site]. 07/01/01. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=123&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=cryosurgery&KeyWordLookUp=Title&KeyWordSearchType=And&ncd_id=230.9&ncd_version=1&basket=ncd*3a%24230.9*3a%241*3a%24Cryosurgery+of+Prostate&bc=gAAAACAAAAAAAA%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)

55873


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)

THE FOLLOWING CODE REPRESENTS PRIMARY TREATMENT OF PROSTATE CANCER:
C61 Malignant neoplasm of prostate



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.022a

06/05/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Cryosurgical Ablation of the Prostate Gland.
10/24/2018This policy became effective 04/08/2015. It has been reviewed and reissued to communicate the Company’s continuing position on Cryosurgical Ablation of the Prostate Gland.
03/29/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Cryosurgical Ablation of the Prostate Gland.
07/06/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Cryosurgical Ablation of the Prostate Gland.
04/08/2015This version of the policy becomes effective 04/08/2015.

The company's Experimental/Investigational coverage position on Subtotal Cryoablation was added to the policy.

MA11.022
01/01/2015This is a new policy.




Version Effective Date: 04/08/2015
Version Issued Date: 04/08/2015
Version Reissued Date: 06/05/2019