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Date Printed: October 21, 2017: 11:32 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

04-77260-25

Original Effective Date: 05/01/16

Reviewed: 09/28/17

Revised: 10/15/17

Subject: Fractionation and Radiation Therapy

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:

Metastasis to the bony skeleton is a common site of spread for many solid tumors including breast, prostate and lung cancers. Bone metastases can be seen with any cancer histology and affects more than 2500,000 patients per year in the United States. It has been estimated that up to 80% of patients with solid cancers will develop painful bone metastases to the pelvis, spine or extremities during the course of their illness. Metastases to the bone can cause accelerated bone breakdown which may result in pain, pathologic fracture and nerve or spinal cord compression resulting in sensory loss or motor weakness. Laboratory abnormalities may include hypercalcemia and myelosuppression. Radiation therapy has long been used to palliate pain and other symptoms of bone metastases with excellent results. Following initial treatment with radiation therapy for bony metastasis, some patients will develop recurrent or progressive symptoms for which additional radiation therapy is indicated. Studies have shown repeat radiation therapy to be effective in reducing pain in approximately 48% of patients. Responders have been shown to have improved quality of life. When a given site is re-treated, the effect of prior irradiation on the surrounding normal tissues must be taken into account. This is especially important when treating vertebral lesions where to cumulative dose to the spinal cord must be minimized.

Whole breast irradiation (WBI) is a well-established and integral component of breast conservation therapy (BCT). When given after lumpectomy, WBI has been shown to result in equivalent survival when compared to mastectomy. When compared to lumpectomy alone, the addition of radiation therapy significantly reduces the risk of local recurrence and has even been shown to improve overall survival in some patients. Conventionally fractioned WBI usually consists of treatment to doses of 45 to 50 Gy in daily doses of 1.8-2 Gy. Additional “boost” treatment to the tumor bed has been shown to further decrease the risk of local recurrence in several randomized trials, especially in younger women and those with high grade lesions. Adjuvant radiotherapy is an important component of treatment for ductal carcinoma in situ (DCIS). For external beam WBI, 3D conformal planning techniques are commonly used to achieve a uniform dose distribution throughout the breast. Reasonable cosmesis can be achieved and toxicity can be limited using standard wedges, electronic compensation or forward planned field-in-field segments with custom blocking. There is a growing body of evidence that selected women with early state breast cancer and favorable anatomy are suitable candidates for accelerated whole breast irradiation (AWBI). Benefits of AWBI include a decrease in the number of visits for daily treatment and a reduction in the overall cost of care. Intraoperaive radiotherapy (IORT) is a form of accelerated partial breast irradiation (APBI) in which the entire partial breast treatment is delivered at the time of lumpectomy. Several systems have been approved to deliver treatment with either electrons or 50 kV x-rays.

POSITION STATEMENT:

Bone Metastases

Single fraction radiation treatment for bone metastases meets the definition of medical necessity in members who meet any of the following criteria:

• Poor performance status, defined as **Karnofsky (KPS) Performance Scale ≤ 50 or *ECOG performance status 3-4; OR

• Goal of therapy is pain relief

Fractionated radiotherapy for bone metastases, 2 to 10 fractions meets the definition of medical necessity only for members who meet the following criteria:

Fair to good performance status, defined as **Karnofsky (KPS) Performance Scale ≥ 60 or *ECOG performance status 0-2 and any of the following:

• Pathologic fracture; OR

• Soft tissue involvement by tumor; OR

• Spinal cord compression; OR

• Spine metastasis; OR

• Presence of oligometastatic disease (1-5 lesions) when the goal of treatment is long term stabilization of disease.

Fractionation for bone metastases beyond 10 treatments does not meet the definition of medical necessity.

*Eastern Cooperative Oncology Group (ECOG) Performance Status

**Karnofsky Performance Scale (KPS)

Breast Cancer

Whole breast irradiation (WBI)

Whole breast irradiation (WBI): 17 to 28 fractions of WBI meet the definition of medical necessity only for members who meet any one of the following criteria:

• Age less than 50; OR

• Tumor greater than 5 cm; OR

• Lymph node involvement requiring treatment the supraclavicular or internal mammary nodal regions; OR

• Mastectomy or breast reconstruction have been performed; OR

• Treatment will be delivered with 3D conformal radiotherapy and the treatment plan results in dose inhomogeneity of greater than 7% in the central axis (for example, if the plan is normalized to 95%, the maximum dose is greater than 112%); OR

• Concurrent chemotherapy or transtuzumab will be administered.

For members not meeting one of these criteria, up to 16 fractions of WBI meets the definition of medical necessity.

Breast boost irradiation

• An additional boost of up to 8 fractions of WBI meets the definition of medical necessity when the member has fulfilled the above criteria for 17-28 fractions of WBI.

• For members not meeting the above criteria for WBI, an additional boost of up to 5 fractions of WBI meet the definition of medical necessity.

More than 36 fractions of radiation (including whole breast irradiation and boost irradiation) do not meet the definition of medical necessity.

Note: If high risk features such as a positive surgical margin or lymph node involvement are present on the final pathology, then the intraoperative treatment will be considered the boost therapy and the member should offered whole breast irradiation.

Accelerated partial breast irradiation (APBI)

Accelerated partial breast irradiation (APBI) delivered with up to 10 fractions of radiation delivered twice daily meet the definition of medical necessity.

Accelerated partial breast irradiation (APBI) delivered with more than 10 fractions of radiation do not meet the definition of medical necessity.

Intraoperative radiation therapy (IORT)

Intraoperative radiation therapy (IORT) delivered as a single fraction of radiation meets the definition of medical necessity.

Intraoperative radiation therapy (IORT) delivered as more than one fraction of radiation does not meet the definition of medical necessity.

BILLING/CODING INFORMATION:

CPT Code:

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

77301

Intensity modulated radiotherapy plan, including dose – volume histograms for target and critical structure partial tolerance specifications

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)

77338

Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan

77373

Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions

77385

Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple

77386

Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex

77435

Stereotactic body radiation therapy, treatment management, per treatment course, to one or more lesions, including image guidance, entire course not to exceed 5 fractions

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

HCPCS Coding:

G0339

Image guided robotic linear accelerator base stereotactic radiosurgery, complete course of therapy in one session, or first session of fractionated treatment

G0340

Image guided robotic linear accelerator based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five session per course of treatment

G6015

Intensity modulated treatment delivery, single or multiple fields/arcs,via narrow spatially and temporally modulated beams, binary, dynamic mlc, per treatment session

G6016

Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session

ICD-10 Diagnosis Codes That Support Medical Necessity:

C50.011 – C50.929

Malignant neoplasm of breast

C79.51 – C79.52

Secondary malignant neoplasm of bone and bone marrow

C79.81

Scondary malignant eoplasm of the breast

D05.00 – D05.92

Carcinoma in situ breast

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 fractionation and radiation therapy.

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 special treatment procedure and special physics consult 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 imaged-guided radiation therapy 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 reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Brachytherapy (Oncologic Applications), 04-77260-20
Stereotactic Body Radiotherapy, 02-77371-02

Stereotactic Radiosurgery (Intracranial), 02-77371-01

OTHER:

Functional Status Tools

The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is used to quantify the functional status of cancer patients and is a factor in determining prognosis in a number of malignant conditions. The PS describes the status of symptoms and functions with respect to ambulatory status and need for care. PS 0 means normal activity, PS 1 means some symptoms, but still near fully ambulatory, PS 2 means less than 50%, and PS 3 means more than 50% of daytime in bed, while PS 4 means completely bedridden.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Performance Status (PS) Score

ECOG

0

Fully active, able to carry on all predisease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work)

2

Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited self-care, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

5

Dead

Adapted from: Blagden SP, Charman SC, Sharples LD et al 2003. Performance status score: do patients and their oncologists agree? British Journal of Cancer 2003; 89(6): 1022-1027

The Karnofsky Performance Scale (KPS) allows patients to be classified as to their functional impairment. The scale relates to physical ability and covers 11 stages, ranging from normal health to death, with each stage scored as a percentage. A score between 0 and 100 is assigned by a healthcare professional after observing a patient perform a tasks and/or activity of daily living. A score of 100% means that the patient has normal physical abilities with no signs of disease, decreasing percentage means that the patient has less ability to perform activities of daily living. The Karnofsky Performance Scale can be used to compare effectiveness of different therapies and to assess patient’s prognosis.

Karnofsky Performance Scale (KPS)

General Category

%

Criteria

• Able to carry on normal activity and work

• No special care needed

100

Normal no complaints; no evidence of disease.

90

Able to carry on normal activity; minor signs or symptoms of disease.

80

Normal activity with effort; some signs or symptoms of disease.

• Unable to work

• Able to live at home and care for most personal needs

• Varying amount of assistance needed

70

Cares for self; unable to carry on normal activity or to do active work.

60

Requires occasional assistance, but is able to care for most of his personal needs.

50

Requires considerable assistance and frequent medical care.

• Unable to care for self

• Requires equivalent of institutional or hospital care

• Disease may be progressing rapidly

40

Disabled; requires special care and assistance.

30

Severely disabled; hospital admission is indicated although death not imminent.

20

Very sick; hospital admission necessary; active supportive treatment necessary.

• Terminal state

10

Moribund

 

0

Dead

Adapted from: Crooks V, Waller S, Smith T et al. The Use of the Karnofsky Performance Scale in Determining Outcomes and Risk in Geriatric Outpatients. The Journals of Gerontology 1991 Jul; 46(4): M139-M144

REFERENCES:

  1. AIM Specialty Health Clinical Appropriateness Guideline: Radiation Oncology Bone Metastases, 09/17.
  2. AIM Specialty Health Clinical Appropriateness Guideline: Radiation Oncology Breast Cancer, 09/17.
  3. American Society of Breast Surgeons Consensus Statement for Accelerated Partial Breast Irradiation, revised 08/15/2011.
  4. Blagden SP, Charman SC, Sharples LD et al 2003. Performance status score: do patients and their oncologists agree? British Journal of Cancer 2003; 89(6): 1022-1027.
  5. Crooks V, Waller S, Smith T et al. The Use of the Karnofsky Performance Scale in Determining Outcomes and Risk in Geriatric Outpatients. The Journals of Gerontology 1991 Jul; 46(4): M139-M144.
  6. Expert Panel on Radiation Oncology –Bone Metastases: Kim EY, Chapman TR, Ryu S et al. American College of Radiology ACR Appropriateness Criteria® non-spinal metastases, 2014.
  7. Expert Panel on Radiation Oncology –Bone Metastases: Lo SS, Lutz ST, Chang EL et al. American College of Radiology ACR Appropriateness Criteria® spinal metastases, 2012.
  8. Lutz S, Berk L, Chang E et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. International Journal Radiation Onoclogy, Biology, Physics 2011; 79(4): 965-976.
  9. Moran MS, Schnitt SJ, Giuliano AE et al. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Journal of Clinical Oncology 2014; 88(3): 553-564.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Bone Cancer. Version 2.2016.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer. Version 2.2017-April 6, 2017.
  12. Smith BD, Arthur DW, Buchholz TA et al. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). International Journal Radiation Onoclogy, Biology, Physics 2009; 74(4): 987-1001.
  13. Smith BD, Bentzen SM, Correa CR et al. Fractionation for whole breast irradiation: an American Society for Radiation Oncology (ASTRO) evidence-based guideline. International Journal Radiation Onoclogy, Biology, Physics 2011; 81(1): 59-68.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/28/17.

GUIDELINE UPDATE INFORMATION:

05/01/16

New Medical Coverage Guideline

01/01/17

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

10/15/17

Revision; revised position statement. Updated references.

Date Printed: October 21, 2017: 11:32 AM