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04-77260-20

Original Effective Date: 11/15/10

Reviewed: 10/19/16

Revised: 01/01/17

Subject: Brachytherapy-Oncologic Applications

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Update    
           

DESCRIPTION:

Brachytherapy is a type of radiation therapy that utilized radioactive isotopes for internal treatment of malignancies or benign conditions by means of a radioactive source placed directly on the target surface, into a body cavity (intracavitary), within the body tissues (interstitial) or near the tumor or target tissue.

Intracavitary brachytherapy is performed by placement of applicators directly in a tumor or body cavity. The applicator is loaded with a radioactive isotope (e.g., radium, cesium, iridium). Interstitial brachytherapy is performed by placement of applicators directly within body tissues. Interstitial brachytherapy is performed with needles, ribbons, or wires containing radioactive materials. Brachytherapy that requires penetration of the skin or surgery for applicator insertion is considered interstitial. Surface application brachytherapy involves the application of radioactive materials that are placed directly on the skin or other external target surface. Some radioactive materials may be left in place permanently or temporarily.

Brachytherapy may be used alone as the sole treatment or as an adjunctive treatment with external beam radiation therapy (EBRT) or other modalities such as surgery or chemotherapy. Brachytherapy may be either temporary or permanent. Brachytherapy radiation dose may be delivered at a low-dose rate (LDR), high-dose rate (HDR), or pulsed dose-rate (PDR). Low-dose rate brachytherapy radioactive isotopes may be placed either temporarily or permanently and is manually or remotely loaded into applicators to deliver the prescribed treatment at a continuous rate over several hours or days. LDR brachytherapy is may be delivered at a continuous rate over several hours or days in a hospital setting or in an ambulatory or setting. High-dose rate brachytherapy radioactive isotopes are temporary and are delivered by remote after-loading. Pulsed dose-rate brachytherapy treatment delivery is similar to LDR, but occurs in periodic pulses, usually one per hour rather than continuously.

The clinical use of brachytherapy is complex and may involve multiple medical specialists (e.g., radiation oncologist, medical physicist, radiation therapists, dosimetrist). In addition to a radiation oncologist, brachytherapy may require that other specialists perform related but separate procedures before, during, or after brachytherapy.

POSITION STATEMENT:

Note: For Fractionation and Radiation Therapy, refer to Fractionation and Radiation Therapy, 04-77260-25.

Brachytherapy meets the definition of medical necessity for the following indications:

Breast Cancer

Brachytherapy for breast cancer meets the definition of medical necessity only when used to deliver any one of the following:

Intraoperative radiation therapy (IORT) meets the definition of medical necessity only for members who meet ALL of the following criteria:

• Age 50 or greater; AND

• Tumor less than or equal to 3 cm with grossly uninvolved surgical margins; AND

• Lymph nodes are grossly negative and negative on intraoperative frozen section if performed; AND

• Distance between the edge of the applicator and the skin is at least 6 mm.

Accelerated partial breast irradiation (APBI) meets the definition of medical necessity only for members who meet ALL of the following criteria:

• Age 45 or greater for invasive disease or greater than 50 for DCIS; AND

• Tumor less than or equal to 3 cm with pathologically negative surgical margins; AND

• Lymph nodes are negative or show only immunohistochemical involvement, N0 or N0 (i+); AND

• Distance between the edge of the applicator and the skin is at least 6 mm.

Note: If intraoperative radiotherapy was used at the time of surgery but the final pathologic evaluation reveals indications for whole breast irradiation, the IORT will be considered the boost portion of the treatment.

Ocular Lesions

Uveal Melanoma

Brachytherapy for uveal melanoma meets the definition of medical necessity when ALL of the following are met:

When apical height of the tumor is up to 10.0 mm; AND

• The maximal base diameter is 18.0 mm or less.

Retinoblastoma

Brachytherapy for retinoblastoma meets the definition of medical necessity when ALL the following are met:

When apical height of the tumor is up to 10.0 mm; AND

The maximal base diameter is 18.0 mm or less.

Cholangiocarcinoma

Brachytherapy meets the definition of medical necessity for cholangiocarcinoma when the following is met:

1. As adjuvant treatment after surgery for members with ANY of the following (a, b, OR c ):

a. R1 resection (positive margin); OR

b. R2 resection (gross residual disease after resection); OR

c. Carcinoma in situ found at the surgical specimen margin.

Esophageal Cancer

Brachytherapy meets the definition of medical necessity for esophageal cancer when ANY of the following are met:

To treat a gross residual tumor or unresectable luminal lesion; OR

For palliative treatment of an obstructing tumor.

Genitourinary

Penile Cancer

Brachytherapy meets the definition of medical necessity for penile cancer when the following are met:

Squamous cell carcinoma, confined to the glans or prepuce when:

Tumor size is less than or equal to 4 cm; AND

• Inguinal lymph nodes are uninvolved or unable to be assessed (N0 or NX).

Other Genitourinary Cancers

Brachytherapy meets the definition of medical necessity for the following:

• Bladder

• Urethral.

Gynecologic Cancers (cervical, uterine, and vulvar/vaginal)

Cervical Cancer

Brachytherapy meets the definition of medical necessity for cervical cancer when the following is met:

• To treat primary cervical cancer.

Uterine Neoplasms (endometrial carcinoma, uterine sarcoma, uterine carcinosarcoma)

Brachytherapy meets the definition of medical necessity for uterine neoplasms when the following is met:

• To treat members with cancer of the uterus, including uterine sarcoma and endometrial carcinoma.

Vulvar/Vaginal Cancer

Brachytherapy meets the definition of medical necessity for vulvar/vaginal cancer when the following is met:

To treat members with vaginal or vulvar cancer.

Prostate Cancer

Prostate Cancer Disease Definitions

Low-risk of recurrence (all must be present to qualify as low risk)

Stage T1-T2a; AND

Gleason less than or equal to 6; AND

Prostate-specific Antigen (PSA) below10 ng/mL

Intermediate-risk of recurrence (any one characteristic)

Stage T2b to T2c; OR

Gleason score of 7; OR

PSA 10-20 ng/mL

High-risk of recurrence (any one characteristic)

Stage T3a; OR

Gleason score 8-10; OR

PSA greater than 20 ng/mL

Localized disease

T stage of T1-3a (tumor has spread through the capsule on one or both sides but has not invaded the seminal vesicles

or other structures); AND

N0 (no lymph node involvement)

Locally advanced disease

Any T status with N1 disease (either no spread to lymph nodes or there has been spread to the regional lymph nodes); OR

T3b and above, no distant metastatic disease beyond local lymph nodes

Distant metastatic disease

Beyond the local lymph nodes

Low risk of recurrence

Brachytherapy meets the definition of medical necessity for prostate cancer for the following:

• Permanent low dose rate brachytherapy is used as monotherapy.

Note: Active surveillance is a reasonable alternative to radiation treatment in members with low risk prostate cancer.

Intermediate risk of recurrence

To treat a previously irradiated field

Brachytherapy in combination with external beam radiotherapy meets the definition of medical necessity for prostate cancer when ANY of the following are met:

Low-dose rate (LDR) brachytherapy; OR

High-dose rate (HDR) brachytherapy.

High or very high risk of recurrence

Brachytherapy meets the definition of medical necessity for prostate cancer when the following is met:

• Used in combination with external beam radiation.

Local Recurrence

Brachytherapy meets the definition of medical necessity for prostate cancer for local recurrence when the following is met:

Low-dose rate (LDR) OR High-Dose rate (HDR) brachytherapy

• To treat a local recurrence following external beam radiation or primary brachytherapy.

High Dose Rate Electronic Brachytherapy

High dose rate electronic brachytherapy is considered experimental or investigational for all indications, including, but not limited to the following. There is insufficient evidence in the published peer-reviewed medical literature regarding the safety and efficacy of high dose rate electronic brachytherapy and the impact on health outcomes.

• Breast cancer.

BILLING/CODING INFORMATION:

Note: Procedure and diagnoses codes may not be all inclusive.

CPT Code:

0394T

High dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed (investigational)

0395T

High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed (investigational)

19296

Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy

19297

Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; concurrent with partial mastectomy (List separately in addition to code for primary procedure)

19298

Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time of or subsequent to) partial mastectomy, includes imaging guidance

20555

Placement of needles or catheters into muscle and/or soft tissue for subsequent interstitial radioelement application (at the time of or subsequent to the procedure)

41019

Placement of needles, catheters, or other devices(s) into the head and/or neck region (percutaneous, transoral, or transnasal) for subsequent interstitial and radioelement application

55875

Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy

55920

Placement of needles or catheters into pelvic organs and/or genitalia (except prostate) for subsequent interstitial radioelement application

57155

Insertion of uterine tandem and/or vaginal ovoids for clinical brachytherapy

57156

Insertion of vaginal radiation after loading apparatus for clinical brachytherapy

58346

Insertion of Heyman capsules for clinical brachytherapy

77280

Therapeutic radiology simulation-aided field setting; simple

77285

Therapeutic radiology simulation-aided field setting; intermediate

77290

Therapeutic radiology simulation-aided field setting; complex

77295

3-dimensional radiotherapy plan, including dose-volume histograms

77316

Brachytherapy isodose plan; simple (calculation(s) made from 1 to 4 sources, or remote afterloading brachytherapy, 1 channel), includes basic dosimetry calculation(s)

77317

Brachytherapy isodose plan; intermediate (calculation(s) made from 5 to 10 sources, or remote afterloading brachytherapy, 2-12 channels), includes basic dosimetry calculation(s)

77318

Brachytherapy isodose plan; complex (calculation(s) made from over 10 sources, or remote afterloading brachytherapy, over 12 channels), includes basic dosimetry calculation(s)

77424

Intraoperative radiation treatment delivery, x-ray, single treatment session

77425

Intraoperative radiation treatment delivery, x-ray, single treatment session

77469

Intraoperative radiation treatment management

77750

Infusion or instillation of radioelement solution

77761

Intracavitary radiation source application; simple

77762

Intracavitary radiation source application; intermediate

77763

Intracavitary radiation source application; complex

77767

Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter up to 2.0 cm or 1 channel

77768

Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter over 2.0 cm and 2 or more channels, or multiple lesions

77770

Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 1 channel

77771

Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; 2-12 channels

77772

Remote afterloading high dose rate radionuclide interstitial or intracavitary brachytherapy, includes basic dosimetry, when performed; over 12 channels

77778

Interstitial radiation source application; complex

77789

Surface application of low dose rate radionuclide source

77790

Supervision, handling, loading of radiation source

77799

Unlisted procedure, clinical brachytherapy

HCPCS Coding:

G0458

Low dose rate (LDR) prostate brachytherapy services, composite rate

Q3001

Radioelements for brachytherapy any type

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C00.0 – C00.9

Malignant neoplasm of lip

C01

Malignant neoplasm of base of tongue

C02.0 – C02.9

Malignant neoplasm of other and unspecified parts of tongue

C03.0 – C03.9

Malignant neoplasm of gum

C04.0 – C04.9

Malignant neoplasm of floor of mouth

C06.0 – C06.2

Malignant neoplasm of other and unspecified parts of m Malignant neoplasm of mouth

C06.80 – C06.89

Malignant neoplasm of overlapping sites of other and unspecified parts of mouth

C06.9

Malignant neoplasm of mouth, unspecified

C07

Malignant neoplasm of parotid gland

C08.0 – C08.9

Malignant neoplasm of other and unspecified major salivary Malignant neoplasm of glands

C09.0 – C09.9

Malignant neoplasm of tonsil

C10.0 – C10.9

Malignant neoplasm of oropharynx

C11.0 – C11.9

Malignant neoplasm of nasopharynx

C13.0 – C13.9

Malignant neoplasm of hypopharynx

C14.0 – C14.8

Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

C15.3 – C15.9

Malignant neoplasm of esophagus

C22.1

Intrahepatic bile duct carcinoma

C24.0

Malignant neoplasm of extrahepatic bile duct

C30.0 – C30.1

Malignant neoplasm of nasal cavity and middle ear

C31.0 – C31.9

Malignant neoplasm of accessory sinuses

C32.0 – C32.9

Malignant neoplasm of larynx

C34.00 – C34.02

Malignant neoplasm of main bronchus

C34.10 – C34.12

Malignant neoplasm of upper lobe, bronchus or lung

C34.2

Malignant neoplasm of middle lobe, right bronchus or lung

C34.30 – C34.32

Malignant neoplasm of lower lobe, bronchus or lung

C34.80 – C34.82

Malignant neoplasm of overlapping sites of bronchus and lung

C34.90 – C34.92

Malignant neoplasm of bronchus or lung

C49.0

C49.10 – C49.12

C49.20 – C49.22

C49.3 – C49.9

Malignant neoplasm of other connective and soft tissue

C50.011 – C50.929

Malignant neoplasm of breast

C51.0 – C51.9

Malignant neoplasm of vulva

C52

Malignant neoplasm of vagina

C53.0 – C53.9

Malignant neoplasm of cervix uteri

C54.0 – C54.9

Malignant neoplasm of corpus uteri

C55

Malignant neoplasm of uterus, part unspecified

C57.7

Malignant neoplasm of other and specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C60.0 – C60.9

Malignant neoplasm of penis

C61

Malignant neoplasm of prostate

C69.20 – C69.22

Malignant neoplasm of retina

C69.40 – C69.42

Malignant neoplasm of ciliary body

C73

Malignant neoplasm of thyroid gland

C76.0

Malignant neoplasm of head, face and neck

C78.00 – C78.02

Secondary malignant neoplasm of lung

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.81

Secondary malignant neoplasm of breast

C79.82

Secondary malignant neoplasm of genital organs

D00.1

Carcinoma in situ esophagus

D05.00 – D05.92

Carcinoma in situ breast

Z08

Encounter for follow-up examination after completed treatment for malignant neoplasm

Z51.5

Encounter for palliative care

Z98.89

Other specified postprocedural states

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, plan of treatment and reason for brachytherapy.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Plan of treatment

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Note: Coverage for brachytherapy performed and billed in an outpatient or office location will be handled through the Radiation Oncology program for select products. AIM Specialty Health will determine coverage for brachytherapy for select products. Refer to member's contract benefits.

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Fraction: a single session of radiation treatment delivered to a specific area of interest at one setting.

Fractionation: the schedule of fractions of treatment as it is delivered. This is usually expressed as the number of fractions or treatment sessions delivered over a specific period of time.

RELATED GUIDELINES:

Intravascular Brachytherapy for Prevention and Management of Restenosis after Percutaneous Transluminal Angioplasty (PTA), 04-77260-14
Selective Internal Radiation Therapy, 04-777260-21

OTHER:

Other names used to describe brachytherapy:

Implant radiation therapy
Internal radiation therapy
Plaque brachytherapy
Radiation brachytherapy

REFERENCES:

  1. AIM Specialty Health Clinical Appropriateness Guidelines: Radiation Oncology Bone Metastases, Breast Cancer, Central Nervous System Cancers, Colorectal and Anal Cancers, Gastrointestinal Cancers and Non-Colorectal, Genitourinary (Penile and Testicular) Cancers, Gynecologic Cancers, Head and Neck Cancers, Lung Cancer (Small Cell and Non-Small Cell), Other Tumor Types (including Sarcomas, Pediatrics and Other Malignancies) and Prostate Cancer, 2016.
  2. American Brachytherapy Society Brachytherapy Guideline: Breast 10/07/08.
  3. American Brachytherapy Society Brachytherapy Guideline: Cervical Cancer (accessed 09/29/11).
  4. American Brachytherapy Society Brachytherapy Guideline: Prostate High-Dose-Rate (accessed 09/29/11).
  5. American College of Radiology: Practice Guideline for the Performance of High-Dose-Rate Brachytherapy, 2010.
  6. American College of Radiology: Practice Guideline for the Performance of Low-Dose-Rate Brachytherapy, 2010.
  7. American College of Radiology: Practice Guideline for Transperineal Permanent Brachytherapy of Prostate Cancer, 2005.
  8. American Society of Breast Surgeons Consensus Statement for Accelerated Partial Breast Irradiation, 10/07/08.
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  13. Blue Cross Blue Shield Association Medical Policy Reference Manual-Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds (8.01.14), 05/14/09 05/12/11.
  14. Blue Cross Blue Shield Association Medical Policy Reference Manual-High-Dose Rate Temporary Prostate Brachytherapy (8.01.33), 04/14/11.
  15. Blue Cross Blue Shield Association Medical Policy Reference Manual-Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas or Metastasis to the Brain (8.01.15), 04/08/10.
  16. Blue Cross Blue Shield Association Medical Policy Reference Manual-Endobronchial Brachytherapy (8.03.11), 02/2011.
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  22. Crook JM, Jezioranski J,Grimard L et al. Penile brachytherapy: results for 49 patients. International Journal of Radiation Oncology Biology, Physics 2005; 62(2): 460-467.
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  27. First Coast Service Options Medicare Part B Local Coverage Determination-Accelerated Partial Breast Irradiation (APBI), (L29052), 02/02/09.
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  37. Melia M, Moy CS, Reynolds SM et al. Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the collaborative ocular melanoma study: COMS QOLS report no.3. Archives of Ophthalmology 2006; 124(2):226-238.
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  44. Park, CC, Bevan A, Podgorsak MB et al. Emerging technology committee report on electronic brachytherapy: Electronic brachytherapy working group evaluation subcommittee of ASTRO’s emerging technology committee, 05/23/08:1-34.
  45. Petera J, Neumanova R, Odrazka K et al. Perioperative hyperfractionated high-dose rate brachytherapy combined with external beam radiotherapy in the treatment of soft tissue sarcoma. Tumori 2005; 91(4): 331-334.
  46. Petera J, Soumarova R, Ruzickova J et al. Perioperative hyperfractionated high-dose rate brachytherapy for the treatment of soft tissue sarcoma: multicentric experience. Annals of Surgical Oncology 2010;17: 206-210.
  47. Phan TP, Syed Am Puthawala A et al. High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. The Journal of Urology 2007; 177 (1): 123-127.
  48. Rogers LR, Rock JP, Sills AK et al. Results of a phase II trial of the GliaSite radiation therapy system for the treatment of newly diagnosed, resected single brain metastases. Journal of Neurosurgery 2006; 105 (3):375-384.
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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/19/16.

GUIDELINE UPDATE INFORMATION:

11/15/10

New Medical Coverage Guideline.

01/01/11

Annual HCPCS coding update; added 57156. Revised 57155 code descriptor.

02/15/11

Updated Medicare Advantage program exception.

04/01/11

First quarter HCPCS update; deleted S2270.

10/01/11

Revision; formatting changes.

12/15/11

Annual review; maintain position statements. Updated references.

04/01/12

Update; added related ICD-10 codes.

01/01/13

Annual HCPCS coding update; added G0458.

05/11/14

Revision: Program Exceptions section updated.

01/01/15

Annual HCPCS code update. Deleted 77326, 77327 and 77328. Added 77316, 77317 and 77318.

10/01/15

Revision; updated ICD9 and ICD10 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS code update. Added 0394T, 0395T, 77767, 77768, 77770, 77771, 77772, 77776 and 77777. Deleted 0182T, 77785, 77786 and 77787. Revised 77789 code descriptor. Updated program exceptions.

05/01/16

Revision; added/revised indications: breast cancer, central nervous system (CNS) cancers (intracranial, spinal, ocular, and neurologic indications), gastrointestinal cancers, non-colorectal (cholangioangiocarcinoma, esophageal, gastric, liver, and pancreatic), genitourinary, penile, gynecologic cancers (cervical, uterine, and vulvar/vaginal), and prostate cancer); added 77280, 72285, 77290, 77295, and 77799; updated ICD-10 codes; updated program exception; updated references.

08/15/16

Updated program exceptions.

08/31/16

Formatting change to Position Statement; APBI

11/15/16

Revision; revised position statement. Added 77424, 77425 and 77469. Updated references.

01/01/17

Annual HCPCS code update. Revised 19296, 19297 and 19298 code descriptor.

Date Printed: June 26, 2017: 01:26 AM