High-Dose Rate Temporary Prostate Brachytherapy

POLICY NUMBER

A.8.01.33

DESCRIPTION

High-dose rate (HDR) temporary prostate brachytherapy is a technique for delivering a high-intensity radiation source directly to the prostate gland to treat cancer. The radiation source is administered through hollow catheters or needles inserted precisely into several areas of the prostate gland using ultrasound guidance and treatment planning computed tomography or ultrasound images. Radiation is applied to target areas until the prescribed dose is reached and is then removed. The goal of treatment is to induce direct tumor necrosis and reduce toxicity and surrounding tissue damage.

Prostate Brachytherapy

Brachytherapy for prostate cancer can be delivered in a variety of ways. Perhaps the most common technique uses radioactive seeds permanently implanted into the prostate tissue. These seeds contain isotopes that slowly emit radiation of relatively low energy. In contrast, temporary prostate brachytherapy involves the use of higher energy radioisotopes such as iridium 192. The latter isotopes deliver radiation at higher dose rates than permanent seeds and may be more effective in destroying rapidly dividing cancer cells. For implantation, needle catheters are placed into the prostate gland using transrectal ultrasound guidance. Once placed, a dosimetric plan is developed, and the radioactive source is inserted into each needle using an after-loading device. The radioactive source is left in the needle for a predetermined time, called the “dwell” time. The radiation usually is delivered once or twice daily over several days. The dwell time can be altered at various positions along the needle’s length to control dose distribution to the target volume and critical surrounding structures, such as the rectum or urethra. This strategy contrasts with permanent seed implantation in which dosimetry is calculated before needle placement and which cannot be altered after seed implantation. Treatment typically consists of delivering a dose of 4,000 to 5,000 centigray with external-beam radiotherapy (EBRT) to the prostate and periprostatic tissues, while high-dose rate (HDR) brachytherapy is used as the method of dose escalation to the prostate gland. Total boost doses vary. Additionally, studies are also being conducted using high-dose rate brachytherapy as the sole treatment modality (monotherapy) for prostate cancer.

It is accepted that increasing doses of radiotherapy are associated with improved biochemical control (i.e., stable levels of prostate-specific antigen), and thus there has been an interest in exploring different techniques of dose escalation, simultaneously limiting both early and late toxicities in surrounding tissues. In individuals with the locally advanced disease, it is hypothesized that local failure might be related to large tumor volume and radioresistant cell clones, both of which might respond to higher radiation doses. High-dose rate brachytherapy has been primarily investigated as an adjunct to EBRT for dose escalation. Other techniques for dose escalation include EBRT using intensity-modulated radiotherapy for treatment planning and delivery, proton beam therapy (which may also use intensity-modulated radiotherapy), or EBRT combined with brachytherapy using interstitial seeds.

A number of devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process to deliver high-dose rate brachytherapy to the prostate. The Martinez Prostate Template Set and the Photon Technologies HDR Prostate Template and Accessories are two examples of radiation application devices. These devices are intended as accessories to commercially available HDR remote afterloader systems for prostate brachytherapy.

Related policies:

• Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds

• Whole Gland Cryoablation of Prostate Cancer

POLICY

High-dose rate prostate brachytherapy may be considered medically necessary as monotherapy or in conjunction with external-beam radiotherapy in the treatment of localized prostate cancer.

High-dose rate prostate brachytherapy is considered investigational in the treatment of prostate cancer when used as salvage therapy.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

High-dose rate brachytherapy as monotherapy is being used in low- and intermediate-risk individuals with localized prostate cancer. High-dose rate brachytherapy combined with external-beam radiotherapy (3-dimensional conformal radiotherapy [3D-CRT], intensity-modulatedradiotherapy, or proton beam therapy) may be used for more advanced or aggressive prostate cancers. Adequate dose escalation should be achieved with combination high-dose rate temporary brachytherapy and 3D-CRT. Intensity-modulated radiotherapy should be limited only to cases in which 3D-CRT planning is not able to meet dose volume constraints for normal tissue tolerance. Permanent low-dose rate brachytherapy using only implanted seeds is generally used in individuals whose prostate cancer is considered low risk. Active surveillance is generally recommended for very low risk prostate cancer. Permanent brachytherapy combined with external-beam radiotherapy is used (sometimes along with androgen deprivation therapy) to treat higher-risk disease.

Prostate cancer risk is often defined using the following criteria (American Cancer Society):

• Low risk: PSA level of 10 ng/mL or less, Gleason score of 6 or less, and clinical stage T1c (very low risk) or T1 to T2a.

• Intermediate risk: PSA level greater than 10 but 20 ng/mL or less, or Gleason score 7, or clinical stage T2b to T2c.

• High risk: PSA level greater than 20 ng/mL or Gleason score 8 to 10, or clinical stage T3a for clinically localized disease and T3b to T4 (very high risk) for locally advanced disease.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2000: Approved by Medical Policy Advisory Committee (MPAC), CPT code 76872-76873 added.

5/23/2001: Code Reference section revised, CPT code 55860, 77326-77328, 77781-77784 added, ICD-9 procedure code 60.0, 92.27 added, ICD-9 diagnosis code 185,198.82, 233.4 added, HCPCS “All Codes - For brachytherapy needles and radioelements” added.

6/13/2001: Code Reference section updated, CPT code 76965, 77776-77778 added.

2/8/2002: Investigational definition added.

5/1/2002: Type of Service and Place of Service deleted.

9/20/2002: CPT codes 76872-76873 deleted.

8/16/2005: Code Reference section updated, CPT code 55859, 77761, 77762, 77763, 77790 added, CPT code 77326-77328 code range listed separately and description revised, CPT code 77776-77778, 77781-77784 code range listed separately, ICD-9 procedure code 60.99 added, ICD-9 procedure code 92.27 description revised, ICD-9 diagnosis code 185, 198.82, 233.4 deleted, HCPCS “All Codes - For brachytherapy needles and radioelements” deleted, HCPCS Q3001 added.

8/28/2006: Policy reviewed, no changes.

12/28/2006: Code reference section updated per the 2007 CPT/HCPCS revisions.

12/31/2008: Code reference section updated per the 2009 CPT/HCPCS revisions.

06/30/2009: Policy Description section updated to explain procedure; Policy Statement section updated to state monotherapy or in conjunction with external beam radiation therapy may be considered medically necessary while salvage therapy remains investigational; Non-Covered Codes Table removed, Covered Codes Table added, CPT code 76873 added to covered table, CPT codes 77761, 77762, and 77763 deleted from covered table, ICD-9 Diagnosis code 185 added to covered table, HCPCS code C1717 added to covered table, added statement to covered table regarding HCPCS C-codes.

4/12/2010: Description and policy statement reviewed, no changes. Code reference section updated. Description revised for CPT code 55876. CPT codes 77781, 77782, 77783, 77784 deleted from covered table due to codes were deleted as of 12-31-2008.

07/29/2011: Policy reviewed; no changes.

07/19/2012: Policy reviewed. Policy statement unchanged. Policy guidelines updated to add that adequate dose escalation should be achieved with combination permanent brachytherapy and 3D CRT. Therefore, IMRT should be limited only to cases in which 3D CRT planning is not able to meet dose volume constraints for normal tissue tolerance.

10/17/2013: Policy reviewed; no changes.

12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77316, 77317, and 77318.

08/31/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure codes 60.0 and 60.99, added ICD-9 procedure code 92.23, and removed HCPCS C1717.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to remove deleted CPT codes 77326, 77327, and 77328. Added new 2016 CPT codes 0395T, 77770, 77771, 77772, and 77799. Code description for CPT code 77778 revised with an effective date of 01/01/2016.

01/08/2016: Policy description updated regarding devices. Medically necessary policy statement updated to change "radiation therapy" to "radiotherapy." Sources section updated.

05/26/2016: Policy number A.8.01.33 added.

08/22/2016: Policy description updated. Policy statements unchanged.

08/11/2017: Policy description updated. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 77776, 77777, 77785, 77786, and 77787.

08/13/2018: Policy reviewed; no changes.

08/15/2019: Policy reviewed; no changes.

10/16/2020: Policy reviewed; no changes.

12/02/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/12/2022: Policy description and Policy Guidelines updated to change "patients" to "individuals." Policy statements unchanged.

08/11/2023: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

04/08/2025: Policy reviewed. Policy statements unchanged. Policy Guidelines updated.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.33

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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