Stereotactic Body Radiation Therapy (L28366)
Contractor Information
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Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - FI - MAC |
LCD Information
L28366 LCD Title Stereotactic Body Radiation Therapy Contractor's Determination Number RAD-039 AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date For services performed on or after 07/16/2008 Original Determination Ending Date Revision Effective Date For services performed on or after 07/01/2011 Revision Ending Date |
Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim, which lacks the necessary information to process the claim.
Medicare National Coverage Determinations Manual, Publication 100-3, Chapter 1, Part 2, Section 160.4
Medicare Program Integrity Manual, Chapter 13.7.1 and Chapter 13.11, E, 3.
The adjective "stereotactic" describes a procedure during which a target lesion is localized relative to a known three dimensional reference system that allows for a high degree of anatomic accuracy and precision. Examples of devices used in SBRT for stereotactic guidance may include a body frame with external reference markers in which a patient is positioned securely, a system of implanted fiducial markers that can be visualized with low-energy (kV) x-rays, and CT-imaging-based systems used to confirm the location of a tumor immediately prior to treatment.
All SBRT is performed with at least one form of image guidance to confirm proper patient positioning and tumor localization. To minimize intra-treatment tumor motion associated with respiration or other motion, some form of motion control or "gating" should be used.
SBRT may be fractionated (up to 5 fractions). Each fraction requires an identical degree of precision, localization and image guidance. Since the goal of SBRT is to intensify the potency of the radiotherapy by completing an entire course of treatment within an extremely accelerated time frame, any course of radiation treatment extending beyond five fractions is not considered SBRT and is not to be billed using these codes.
This LCD addresses only CPT codes 77373 and 77435. Other radiation oncology services (professional and technical) are coded separately and are addressed in the separate LCDs: Radiation Oncology: External Beam/Teletherapy and Intensity Modulated Radiation Therapy. All other acceptable uses of CPT codes 77373 and 77435 are described in the companion LCD, Stereotactic Radiosurgery.
When billing for SBRT delivery, it is not appropriate to bill more than one treatment delivery code on the same day of service, even though some types of delivery may have elements of several modalities (for example, a stereotactic approach with IMRT). Only one delivery code is to be billed.
Indications
- SBRT for lung, liver, kidney, and, or pancreas neoplasms:
- The patient's general medical condition (notably, the performance status) justifies aggressive treatment to a primary cancer or, for the case of metastatic disease, justifies aggressive local therapy to one or more discreet deposits of cancer within the context of efforts to achieve total clearance or clinically beneficial reduction in the patient's overall burden of systemic disease. Typically, such a patient would have also been a potential candidate for alternate forms of intense local therapy applied for the same purpose (e.g. surgical resection, radiofrequency ablation, cryotherapy, etc).
- Other forms of radiotherapy, including but not limited to external beam and IMRT, cannot be as safely or effectively utilized, and
- The tumor burden can be completely targeted with acceptable risk to critical normal structures
- If the tumor histology is germ cell or lymphoma, effective chemotherapy regimens have been exhausted or are otherwise not feasible.
- Other forms of focal therapy, including but not limited to radiofrequency ablation and cryotherapy, cannot be as safely or effectively utilized.
- SBRT for Prostate Neoplasms
SBRT of the prostate is covered as monotherapy for patients with low risk and low/intermediate risk prostate cancer when: - The patient's general medical condition (notably, the performance status) justifies aggressive treatment to a primary cancer. Typically, such a patient would have also been a potential candidate for alternate forms of intense local therapy applied for the same purpose.
- Other forms of radiotherapy, including but not limited to external beam and IMRT or seed implantation, cannot be as safely or effectively utilized, and
- The tumor burden can be completely targeted with acceptable risk to critical normal structures
- Other Neoplasms:
Lesions of bone, breast, uterus, ovary and other internal organs not listed above are not covered for primary definitive SBRT as literature does not support an outcome advantage over other conventional radiation modalities, but may be appropriate for SBRT in the setting of recurrence after conventional radiation modalities.
-
Other Indications for SBRT:
Except as above, any lesion with a documented necessity to treat using a high dose per fraction of radiation. When using high radiation doses per fraction, high precision is required to avoid surrounding normal tissue exposure.
Lesions which have received previous radiotherapy or are immediately adjacent to previously irradiated fields, where the additional precision of stereotactic radiotherapy is required to avoid unacceptable tissue radiation will be covered when other conditions of coverage are met (see Limitations below) and this necessity is documented in the medical record.
- Treatment unlikely to result in clinical cancer control and/or functional improvement.
- Patients with wide-spread cerebral or extra-cranial metastases
- Patients with poor performance status (Karnofsky Performance Status less than 40), or ECOG Performance Status greater than 3) - see Performance Status scales below.
SBRT is covered for primary and metastatic tumors of the lung, liver, kidney, or pancreas when and only when each of the following criteria are met, and each specifically documented in the medical record:
Limitations:
Coverage will be denied for each of the following:
Karnofsky Performance Scale (Perez and Brady, p 225)
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
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 needs
50 Requires considerable assistance and frequent medical care
40 Disabled; requires special care and assistance
30 Severely disabled; hospitalization is indicated although death not imminent
20 Very sick; hospitalization necessary; active supportive treatment is necessary
10 Moribund, fatal processes progressing rapidly
0 Dead
ECOG Performance Status (Am. J. Clin. Oncol. 5: 649-655, 1982)
0 Fully active, able to carry on all pre-disease performances 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 selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited selfcare, confined to bed or chair more than 50 % of waking hours.
4 Completely disables. Cannot carry on any self care. Totally confined to bed or chair
5 Dead
Coding Information
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: We have identified the Type of Bill (TOB) and Revenue Center (RC) codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all TOB and/or RC codes listed. CPT/HCPCS codes are required to be billed with specific TOB and RC codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.| 032X | Radiology - Diagnostic - General Classification |
| 0333 | Radiology - Therapeutic and/or Chemotherapy Administration - Radiation Therapy |
| 034X | Nuclear Medicine - General Classification |
| 035X | CT Scan - General Classification |
| 036X | Operating Room Services - General Classification |
| 040X | Other Imaging Services - General Classification |
| 049X | Ambulatory Surgical Care - General Classification |
| 061X | Magnetic Resonance Technology (MRT) - General Classification |
| 076X | Specialty Services - General Classification |
(Use of 77373 and 77435 are addressed in both this LCD and in the Stereotactic Radiosurgery LCD.)
77373 and 77435 are used in free standing facilities only (i.e. clinic or ASC)
| 77373 | STEREOTACTIC BODY RADIATION THERAPY, TREATMENT DELIVERY, PER FRACTION TO 1 OR MORE LESIONS, INCLUDING IMAGE GUIDANCE, ENTIRE COURSE NOT TO EXCEED 5 FRACTIONS |
| 77435 | STEREOTACTIC BODY RADIATION THERAPY, TREATMENT MANAGEMENT, PER TREATMENT COURSE, TO 1 OR MORE LESIONS, INCLUDING IMAGE GUIDANCE, ENTIRE COURSE NOT TO EXCEED 5 FRACTIONS |
In the Hospital Outpatient Setting use the following codes
| C9728 | PLACEMENT OF INTERSTITIAL DEVICE(S) FOR RADIATION THERAPY/SURGERY GUIDANCE (EG, FIDUCIAL MARKERS, DOSIMETER), FOR OTHER THAN THE FOLLOWING SITES (ANY APPROACH): ABDOMEN, PELVIS, PROSTATE, RETROPERITONEUM, THORAX, SINGLE OR MULTIPLE |
| G0251 | LINEAR ACCELERATOR BASED STEREOTACTIC RADIOSURGERY, DELIVERY INCLUDING COLLIMATOR CHANGES AND CUSTOM PLUGGING, FRACTIONATED TREATMENT, ALL LESIONS, PER SESSION, MAXIMUM FIVE SESSIONS PER COURSE OF TREATMENT |
| G0339 | IMAGE-GUIDED ROBOTIC LINEAR ACCELERATOR-BASED 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 SESSIONS PER COURSE OF TREATMENT |
Codes for the surgeons work
| 31626 | BRONCHOSCOPY, RIGID OR FLEXIBLE, INCLUDING FLUOROSCOPIC GUIDANCE, WHEN PERFORMED; WITH PLACEMENT OF FIDUCIAL MARKERS, SINGLE OR MULTIPLE |
| 32553 | PLACEMENT OF INTERSTITIAL DEVICE(S) FOR RADIATION THERAPY GUIDANCE (EG, FIDUCIAL MARKERS, DOSIMETER), PERCUTANEOUS, INTRA- THORACIC, SINGLE OR MULTIPLE |
| 49411 | PLACEMENT OF INTERSTITIAL DEVICE(S) FOR RADIATION THERAPY GUIDANCE (EG, FIDUCIAL MARKERS, DOSIMETER), PERCUTANEOUS, INTRA-ABDOMINAL, INTRA-PELVIC (EXCEPT PROSTATE), AND/OR RETROPERITONEUM, SINGLE OR MULTIPLE |
| 55876 | PLACEMENT OF INTERSTITIAL DEVICE(S) FOR RADIATION THERAPY GUIDANCE (EG, FIDUCIAL MARKERS, DOSIMETER), PROSTATE (VIA NEEDLE, ANY APPROACH), SINGLE OR MULTIPLE |
ICD-9 Codes that Support Medical Necessity
ICD-9-CM 197.8 is limited to secondary malignant neoplasms of pancreas and may not be used for other diagnoses.
ICD-9-CM 990 may only be used where prior radiation therapy to the site is the governing factor necessitating SBRT in lieu of other radiotherapy. An ICD-9-CM code for the anatomic diagnosis must also be used.
radiotherapy. An ICD-9-CM code for the anatomic diagnosis must also be used.
| 155.0 | MALIGNANT NEOPLASM OF LIVER PRIMARY |
| 155.1 | MALIGNANT NEOPLASM OF INTRAHEPATIC BILE DUCTS |
| 155.2 | MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY |
| 157.0 - 157.9 | MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED |
| 162.0 - 162.9 | MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED |
| 185 | MALIGNANT NEOPLASM OF PROSTATE |
| 189.0 | MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS |
| 189.1 | MALIGNANT NEOPLASM OF RENAL PELVIS |
| 194.0 | MALIGNANT NEOPLASM OF ADRENAL GLAND |
| 194.6 | MALIGNANT NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA |
| 197.0 | SECONDARY MALIGNANT NEOPLASM OF LUNG |
| 197.7 | MALIGNANT NEOPLASM OF LIVER SECONDARY |
| 197.8 | SECONDARY MALIGNANT NEOPLASM OF OTHER DIGESTIVE ORGANS AND SPLEEN |
| 198.0 | SECONDARY MALIGNANT NEOPLASM OF KIDNEY |
| 198.89 | SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES |
| 227.6 | BENIGN NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA |
| 234.8 | CARCINOMA IN SITU OF OTHER SPECIFIED SITES |
| 237.3 | NEOPLASM OF UNCERTAIN BEHAVIOR OF PARAGANGLIA |
| 990 | EFFECTS OF RADIATION UNSPECIFIED |
Diagnoses that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Any not listed above
General Information
The patient's record must support the necessity and frequency of treatment. Medical records should include not only the standard history and physical but also the patient's functional status and a description of current performance status (Karnofsky Performance Status). See Karnofsky Performance Status listed under Indications and Limitation of Coverage and/or Medical Necessity above.
Documentation should include the date and the current treatment dose. A radiation oncologist must evaluate the clinical and technical aspects of the treatment, and document this evaluation as well as the resulting management decisions.
All documentation must be available upon request of the Medicare contractor.
When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.
The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
- with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.
- CPT 77435 will be paid only once per course of treatment of SBRT.
- CPT 77373 will be paid only once per day of treatment regardless of the number of sessions or lesions.
American Society of Therapeutic Radiation and Oncology and American American Society of Therapeutic Radiation and Oncology and American College of Radiology (ACR) Radiation Oncology Carrier Advisory Committee "Model" Policy
American Association of Neurological Surgeons/Congress of Neurological Surgeons and American Society for Therapeutic Radiology and Oncology and American College of Radiology
Perez CA, et al (Eds.), Principles and Practice of Radiation Oncology, 4th Ed., Philadelphia, Lippincott-Raven, 2003.
Kavanagh, B.D. and Timmerman, R.D.(Eds.); Stereotactic Body Radiation Therapy, Philadelphia, Lippincott Williams & Wilkins, 2005.
Murphy, Martin J.; Tracking Moving organs in Real Time; Seminars in Radiation Oncology, Vol. 14,
No 1, January 2004, 91-100
Murphy, Martin J. et al; The effectiveness if Breath Holding to Stabilize Lung and Pancreas Tumors During Radiosurgery; Int. J. Radiation Oncology Biol. Phys., Vol. 53, No 2 2002, 475-482
Murphy, Martin J. et al, Image-Guided Radiosurgery for Spine and Pancreas; Computer Aided Surgery Vol. 5, 2000 278-288
Schlaefer, A, et al; Feasibility of Four Dimensional Conformal Planning for Robotic Radiosurgery, Medical Physics, Vol. 32, No 12, December, 2005
Amgad, El-Sherif, et al; New Therapeutic Approaches for Early Stage Non-small Cell Lung Cancer; Surgical Oncology, Vol. 14, 2005, 27-32
Koong, Albert C., et al; Phase I Study of Stereotactic Radiosurgery in Patients with Locally Advanced Pancreatic Cancer; Int. J Radiation Oncology Biol. Phys. Vol. 58, No 4; 2004 1017-1021
Koong, Albert C., et al; Phase II Study to Assess the Efficacy of Conventionally Fractionated Radiotherapy Followed by a Stereotactic Radiosurgery Boost in Patients with locally Advanced Pancreatic Cancer; Int. J Radiation Oncology Biol. Phys.; Vol. 63, No. 2, 2005, 320-323
Derweesh, Ithaar H. et al ; Small renal Tumors: Natural History, Observation Strategies, and emerging Modalities of Energy Based Tumor Ablation; The Canadian Journal of Urology; Vol. 10, June 2003
Madsen, Berit L. et al; Stereotactic HypoFractionated Accurate Radiotherapy of the Prostate (SHARP), 33.5GY in Five Fractions for Localized Disease: First Clinical Trial Results; Int. J Radiation Oncology Biol. Phys.; Vol. 67, No. 4, 2007 1099-1105
Brenner, David J.; Hypofractionation for Prostate Cancer Radiotherapy - What are the Issues? (Editorial)
Int. J Radiation Oncology Biol. Phys.; Vol. 57, No. 4 2003, 912-914
Brenner, David J.; Direct Evidence that Prostate Tumors Show High Sensitivity to Fractionation (Low α/β Ratio), Similar to Late Responding Normal Tissue; Int. J Radiation Oncology Biol. Phys., Vol. 52, No.1, 2002, 6-13
Grills, Inge S., et al; High dose Rate Brachytherapy as Prostate Cancer Monotherapy Reduces toxicity Compared to Low Dose Rate Palladium Seeds; The Journal of Urology, Vol.171, March 2004, 1098- 1104
*Freeman, Debra E; King Christopher R; Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes; Radiat Oncol. 2011; 6: 3. Published online 2011 January 10.
Medical Consultants
Contractor Medical Directors
Other contractor policies.
Wisconsin 01/18/2008
Michigan 01/09/2008
Illinois 01/16/2008
Minnesota 01/31/2008
J 5 A and B MAC 5 2008
Legacy A N/A
8/10/2009 - The description for Revenue code 0760 was changed
8/10/2009 - The description for Revenue code 0761 was changed
8/10/2009 - The description for Revenue code 0762 was changed
8/10/2009 - The description for Revenue code 0769 was changed
01/01/2010 HCPCS update which replaced NOC codes for surgeon work with true codes; 07/01/2008 Added ECOG scale and Part A information
8/1/2010 - Bill Type Code 0 was deleted
8/1/2010 - Revenue code 0343 was added to the code range 0340 - 0349
8/1/2010 - Revenue code 0344 was added to the code range 0340 - 0349
8/1/2010 - The description for Revenue code 0320 was changed
8/1/2010 - The description for Revenue code 0321 was changed
8/1/2010 - The description for Revenue code 0322 was changed
8/1/2010 - The description for Revenue code 0323 was changed
8/1/2010 - The description for Revenue code 0324 was changed
8/1/2010 - The description for Revenue code 0329 was changed
8/1/2010 - The description for Revenue code 0333 was changed
8/1/2010 - The description for Revenue code 0340 was changed
8/1/2010 - The description for Revenue code 0341 was changed
8/1/2010 - The description for Revenue code 0342 was changed
8/1/2010 - The description for Revenue code 0349 was changed
8/1/2010 - The description for Revenue code 0350 was changed
8/1/2010 - The description for Revenue code 0351 was changed
8/1/2010 - The description for Revenue code 0352 was changed
8/1/2010 - The description for Revenue code 0359 was changed
8/1/2010 - The description for Revenue code 0360 was changed
8/1/2010 - The description for Revenue code 0361 was changed
8/1/2010 - The description for Revenue code 0362 was changed
8/1/2010 - The description for Revenue code 0367 was changed
8/1/2010 - The description for Revenue code 0369 was changed
8/1/2010 - The description for Revenue code 0400 was changed
8/1/2010 - The description for Revenue code 0401 was changed
8/1/2010 - The description for Revenue code 0402 was changed
8/1/2010 - The description for Revenue code 0403 was changed
8/1/2010 - The description for Revenue code 0404 was changed
8/1/2010 - The description for Revenue code 0409 was changed
8/1/2010 - The description for Revenue code 0490 was changed
8/1/2010 - The description for Revenue code 0499 was changed
8/1/2010 - The description for Revenue code 0610 was changed
8/1/2010 - The description for Revenue code 0611 was changed
8/1/2010 - The description for Revenue code 0612 was changed
8/1/2010 - The description for Revenue code 0614 was changed
8/1/2010 - The description for Revenue code 0615 was changed
8/1/2010 - The description for Revenue code 0616 was changed
8/1/2010 - The description for Revenue code 0618 was changed
8/1/2010 - The description for Revenue code 0619 was changed
8/1/2010 - The description for Revenue code 0760 was changed
8/1/2010 - The description for Revenue code 0761 was changed
8/1/2010 - The description for Revenue code 0762 was changed
8/1/2010 - The description for Revenue code 0769 was changed
11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
55876 descriptor was changed in Group 3
04/25/2011 Annual review
07/01/2011 Merged Legacy A coverage into this LCD and expanding coverage for Legacy A to include prostate cancer
LCD Attachments
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Page Last Updated: Thursday, 07-Jul-2011 16:36:21 CDT
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