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Brachytherapy is a procedure in which a radioactive source (eg, ≥1 radioisotope "seed[s]") is permanently or temporarily implanted into the prostate to treat localized prostate cancer. The radiation in brachytherapy penetrates only short distances and is intended to deliver tumoricidal radioactivity directly to the tumor to improve local control, while sparing surrounding normal tissue. Focal (subtotal) prostate brachytherapy is a form of organ-preserving therapy for small localized prostate cancers. This policy only reviews permanent low-dose rate (LDR) brachytherapy in prostate cancer.
Brachytherapy is a procedure in which a radioactive source (eg, radioisotope "seeds") is used to treat localized prostate cancer. With brachytherapy, the radiation penetrates only short distances; this procedure is intended to deliver tumoricidal radioactivity directly to the tumor and improve local control, while sparing surrounding normal tissue. Local tumor control has been reported to be associated with lower distant metastasis rates and improved patient survival. Seeds can be permanently or temporarily implanted. Permanent (LDR) brachytherapy is generally used for those with low-risk disease; temporary (high-dose rate [HDR]) brachytherapy is typically reserved for intermediate- or high-risk patients. This policy only reviews permanent LDR brachytherapy in prostate cancer.
The proposed biologic advantages of brachytherapy compared with external beam radiotherapy (EBRT) are related to the dose delivered to the target and the dose-delivery rate. The dose rate of brachytherapy sources is generally in the range of 40 to 60 cGy/h, whereas conventional fractionated EBRT dose rates exceed 200 cGy/min. Enhanced normal tissue repair occurs at the LDRs. Repair of tumor cells does not occur as quickly, and these cells continue to die during continued exposure. Thus, from a radiobiologic perspective, LDR radiation causes ongoing tumor destruction in the setting of normal tissue repair. In addition, brachytherapy is performed as a single procedure in the outpatient setting, which may represent a patient preference issue compared with the multiple sessions required to deliver EBRT. The total doses of radiotherapy (RT) that can be delivered may also vary between EBRT and brachytherapy, especially with newer forms of EBRT such as 3-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated radiotherapy (IMRT).
Brachytherapy, generally, is not indicated for patients with a large prostate or those with a urethral stricture, as the procedure results in short-term swelling of the prostate, which can lead to urinary obstruction. As with all forms of RT, there are concerns regarding the long-term risk of treatment-related secondary malignancies. Reports also suggest that the clinician’s level of experience with brachytherapy is correlated with disease recurrence rates.
Studies of permanent brachytherapy have generally used either iodine-125 or palladium-103. Use of cesium-131 is also being studied. Use of iodine-125 requires more seeds, thus reducing dosimetric dependence on any single seed. Postimplant dosimetric assessment should be performed to ensure the quality of the implant and optimal source placement )ie, targeted tumor areas receive the predetermined radiation dosages while nearby structures and tissue are preserved).
Permanent brachytherapy may be used alone as monotherapy or may be combined with EBRT (together known as combined modality therapy [CMT]) as a way to boost the dose of RT delivered to the tumor. CMT can be performed with permanent or temporary brachytherapy. The brachytherapy boost is typically done 2 to 6 weeks after completion of EBRT, although the sequence can vary.
Focal or subtotal prostate brachytherapy is a form of more localized, organ-preserving therapy for small localized prostate cancers. Brachytherapy “seeds” are placed only in the areas where the tumor has been identified rather than throughout the whole prostate gland. The aim of focal therapy is to reduce the occurrence of adverse events that may be associated with brachytherapy, including urinary, bowel, and sexual dysfunction.
A large number of permanently implanted seeds for brachytherapy of prostate cancer have become available since 1999. The U.S. Food and Drug Administration (FDA) has cleared these devices through its 510(k) process, including I-Seed® (Theragenics Corp.), Proxcelan™ Cs-131 (IsoRay Medical), and BrachySource® Brachytherapy Seed Implants (C.R. Bard). The FDA device classification is: Source, Brachytherapy Radionuclide. FDA product code: KXK.
See also High-Dose Rate Temporary Prostate Brachytherapy, Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT), Cryoablation of Prostate Cancer, Charged-Particle (Proton or Helium) Ion Radiation Therapy, Intensity-Modulated Radiatiotherapy (IMRT) of the Prostate
POLICYBrachytherapy using permanent transperineal implantation of radioactive seeds may be considered medically necessary in treatment of localized prostate cancer when used as monotherapy or in conjunction with external beam radiotherapy (EBRT) (See Policy Guidelines).
Focal or subtotal prostate brachytherapy is considered investigational in the treatment of prostate cancer.
Permanent brachytherapy using only implanted seeds is generally used in patients whose prostate cancer is considered low risk. Active surveillance is generally recommended for very low-risk prostate cancer. Permanent brachytherapy combined with EBRT (3D-conformal radiotherapy, intensity-modulated, or proton) is used, sometimes along with androgen deprivation, to treat higher risk disease. Adequate dose escalation should be achieved with combination permanent brachytherapy and 3D-CRT. Intensity-modulated radiotherapy (IMRT) should be limited only to cases in which 3D-CRT planning is not able to meet dose volume constraints for normal tissue tolerance.
Prostate cancer risk is often defined using the following criteria:
Permanent low-dose rate (LDR) brachytherapy, as monotherapy, in the treatment of localized prostate cancer may be best used in men older than 60 years with small volume cancer of low-risk disease (Gleason sum, <7; PSA score, <10 mg/mL; stage T1c). Patients in their 50s or younger may not be considered ideal candidates for brachytherapy based on concerns regarding the durability of treatment and quality-of-life outcomes. However, favorable outcomes in men 60 years or younger treated with brachytherapy for localized prostate cancer have been reported. Ideally, the cancer should be within a prostate with a volume of less than 60 mL. Patients with locally advanced prostate cancer may be undertreated by permanent brachytherapy alone.
The procedure is usually performed in 2 stages; a prostate volume study (CPT code 76873) followed at a later date by the implant itself, which is performed in the operating room with the patient under general or epidural anesthesia. Iodine or palladium are the typical isotopes used; and the selection of isotope is usually based on physician preference. A CT scan is usually performed at some stage after the procedure to determine the quality of the seed placement.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/1997: Approved by the Medical Policy Advisory Committee (MPAC)
8/1999: Addition of medically necessary indication approved by MPAC
5/21/2001: Code Reference section updated, CPT code 55859, 76965 added, ICD-9 procedure code 60.0, 92.28, 92.29 added
7/13/2001: Policy exception for FEP added
2/14/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
3/7/2003: Code Reference section updated, HCPCS G0256, G0261 added
8/3/2005: Code Reference section updated, CPT code 76873, 77326, 77327, 77328, 77761, 77762, 77763, 77776, 77777, 77778 description revised, CPT code 77799 added, ICD-9 procedure code 60.99 added, ICD-9 procedure code 60.0 deleted, ICD-9 diagnosis code 233.4 description revised, HCPCS Q3001 added, HCPCS G0256, G0261 deleted
12/27/2006: Code Reference section updated per the 2007 CPT revisions
6/26/2007: Code Reference section updated per quarterly HCPCS and Category III revisions
6/18/2009: Policy description updated, policy statement updated. CPT4 codes 77402, 77403 and 77406 added to the covered table. HCPC codes C1715, C 2638,C2639, C2640 and C2641 added to covered table.
7/10/2009: CPT code 77404 added to covered table. CPT code 55859 deleted from the covered table due to the code is a deleted code as of 12-31-2006.
7/16/2009: Policy revisions approved by Medical Policy Advisory Committee (MPAC)
3/22/2010: Code reference section updated. Description revised for CPT code 55876.
08/03/2011: Policy reviewed. Policy statement unchanged. Deleted outdated references from the Sources section.
07/19/2012: Added the following policy statement: Focal or subtotal prostate brachytherapy is considered investigational in the treatment of prostate cancer. Policy guidelines updated regarding the use of IMRT.
12/21/2012: Added the following new 2013 CPT code to the Code Reference section: G0458.
10/23/2013: Policy reviewed; no changes.
08/11/2014: Policy title changed from "Brachytherapy for Prostate Cancer" to "Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds." Policy reviewed; description revised. Policy statements unchanged. Policy guidelines updated regarding active surveillance and prostate cancer risk criteria.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77316, 77317, 77318. CPT code description for 77402 revised; effective 01/01/2015. Added the following new 2015 HCPCS codes G6003, G6005, G6006.
08/25/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 92.23. Removed ICD-9 procedure codes 60.99 and 92.28 from the Code Reference section. Added HCPCS codes C2636, C2637, C2642, C2643, C2698, and C2699.
11/02/2015: Policy description updated regarding devices. Medically necessary policy statement updated to change "radiation therapy" to "radiotherapy." Policy guidelines updated regarding permanent low-dose rate brachytherapy in the treatment of localized prostate cancer. Medically necessary and investigative definitions added.
12/31/2015: Code Reference section updated to add new 2016 CPT code 0395T. Removed deleted CPT codes 77326, 77327, 77328, 77404, and 77406. Code description revised for CPT codes 77778 and 77789 with an effective date of 01/01/2016.
05/25/2016: Policy number added.
SOURCE(S)Blue Cross & Blue Shield Association policy No. 8.01.14
CODE REFERENCEThis 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.