LCD/NCD Portal

L31510

 

RADIATION THERAPY FOR T1 BASAL CELL AND SQUAMOUS CELL CARCINOMAS OF THE SKIN

 

10/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

 

External Beam Radiation Therapy (EBRT)

 

Medicare Administrative Contractor (MAC) jurisdiction 9 (J9) will consider medically reasonable and necessary radiation therapy (RT) for Stage T1 (≤2 cm) basal cell carcinoma (BCC) and Stage T1(≤ 2 cm) squamous cell carcinoma (SCC) lesions treated with EBRT when the documented standard process of care supports the indications as outlined below:

• As a primary or secondary treatment for lesions located on the eyelid, nose, ear, lip, face, hands, genitalia, or feet if surgical treatment is not indicated due to function, cosmetic outcome or patient preference.

• Radiation therapy (RT) of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) on the torso may be considered medically reasonable and necessary when the patient is already receiving RT for BCC or SCC for the areas outlined above.

• Radiation therapy (RT) of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) on the torso, scalp, or below the knee may be considered medically reasonable and necessary if the patient has co-morbidities that would prevent surgical intervention of the lesion (e.g., MRSA; current anticoagulation or anti platelet treatment that cannot be discontinued).

• Radiation therapy (RT) for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) below the knee, or on the scalp may be considered medically reasonable and necessary when surgical intervention to remove the lesion would require a skin graft and/or the closure would be complicated, for example due to chronic heart failure with lower extremity edema or due to difficult closure on the scalp.

• For the above indications, accepted treatment protocols for single daily fraction EBRT include planned doses in the 3500 to 6400 cGy range with electrons/photons in 5-32 fractions.

• It is the expectation that fractionated protocols may not be reasonable and necessary for certain patients.

o For example, to relieve symptoms (palliative treatment) or to improve quality of life of patients with certain performance status (ECOG 3 or 4 related to other medical conditions), a complete fractionated protocol may exceed the patient’s medical need.

o For such patients, one fraction of 1000-2000 cGy dose (one treatment delivery) should be considered the treatment of choice.

 

High Dose Rate (HDR) Brachytherapy

 

Medicare Administrative Contractor (MAC) jurisdiction 9 (J9)will consider radiation therapy (RT) for Stage T1 (≤2 cm) basal cell carcinoma (BCC) and Stage T1 (≤2cm) squamous cell carcinoma (SCC) lesions treated with HDR brachytherapy medically reasonable and necessary when the documented standard process of care supports the indications as outlined below:

• As a primary or secondary treatment for lesions located on the:

o Eyelid.

o Nose.

o Ear.

o Lip.

o Face.

o Hands.

o Genitalia.

o Feet.

o if surgical treatment is not indicated due to function, cosmetic outcome or patient preference

Or

• Radiation therapy (RT) of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) on the torso may be considered medically reasonable and necessary when the patient is already receiving RT for BCC or SCC for the areas outlined above.

Or

• Radiation therapy (RT) of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) on the torso, scalp, or below the knee may be considered medically reasonable and necessary if the patient has co-morbidities that would prevent surgical intervention of the lesion (e.g., MRSA; current anticoagulation or anti platelet treatment that cannot be discontinued).

Or

• Radiation therapy (RT) for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) below the knee, or on the scalp may be considered medically reasonable and necessary when surgical intervention to remove the lesion would require a skin graft and/or the closure would be complicated. (For example due to chronic heart failure with lower extremity edema or due to difficult closure on the scalp.).

• Accepted full treatment protocols for HDR brachytherapy include planned doses of 4200 cGy in 6 fractions or up to 5000 cGy in 20 fractions. The typical case is 10 fractions or less.

• As noted under EBRT indications, it is the expectation that fractionated protocols (EBRT or HDR) may not be reasonable and necessary for certain patients.

o For example, to relieve symptoms (palliative treatment) or to improve quality of life of patients with certain performance status (ECOG 3 or 4 related to other medical conditions), a complete fractionated protocol may exceed the patient’s medical need.

o For such patients, one fraction of 1000-2000 cGy dose (one treatment delivery) should be considered the treatment of choice.

 

• Eastern Cooperative Oncology Group: Performance Scale

o Grade and ECOG

 0- Fully active, able to carry on all pre disease activities without restriction.

 1- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, for example light housework/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 limited self-care, confined to bed or chair 50% or more of waking hours.

 4- Completely disabled; cannot carry on any self-care; totally confined to bed or chair.

 5- Dead.

 

Limitations

• Pre cancer skin lesions such as but not limited to actinic or solar keratosis are not covered.

o Cancers limited to the epidermis- Tis, for basal cell carcinoma (carcinoma in situ) of the skin and for squamous carcinoma (squamous carcinoma in situ or Bowen's disease) of the skin can be covered if indications in the coverage section are met and the documentation supports the use of radiation therapy in lieu of other standard interventions.

o Claims for Tis lesions may be subject to medical review.

• Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin > 2cm are not addressed by this LCD, though it is the expectation that radiation therapy for such lesions would meet standards of care and all aspects of the relevant Medicare regulations.

 

• External Beam Radiation Therapy (EBRT)

o It is not expected that the treatment delivery codes 77407, 77408, 77409, 77411, 77412, 77413, 77414, and 77416 will be utilized for treatment of BCC or SCC stage T1 lesions.

 Claims for such services may be developed (records requested when claims submitted) for prepayment medical review.

o Hyperfractionation (BID treatment delivery) is non-covered for treatment of BCC or SCC stage T1 lesions.

o Grenz rays (< 30 KV) are non-covered for any skin cancer condition.

o Radiation treatment delivery, superficial and/or ortho voltage is defined as 50 KV or greater. Energies less than 50 KV are non-covered.

o Intensity modulated radiation therapy (IMRT) (77418) for the treatment of BCC or SCC stage T1 is non-covered.

o Stereotactic radiation treatment delivery and proton beam treatment delivery for the treatment of BCC or SCC stage T1 is non-covered.

 

• High Dose Rate (HDR) Brachytherapy

o Electronic brachytherapy (0182T) describes HDR brachytherapy that delivers radiation from a non-radionuclide source and is currently non-covered for any skin cancer indication.

o Hyperfractionation (BID treatment delivery) is non-covered for treatment of BCC or SCC stage T1 lesions.

o CPT code 77787 (Remote afterloading high dose rate radionuclide brachytherapy; over 12 channels) is non-covered for treatment of BCC or SCC stage T1 lesions.

 

• Additional limitations

• In order to be covered under Medicare, a service shall be reasonable and necessary.

o When appropriate, contractors shall describe the circumstances under which proposed LCD for the service is considered reasonable and necessary under 1862 (a) (1) (A).

o  Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:

 Safe and effective; not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).

And

 Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:

 Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.

 Furnished in a setting appropriate to the patient’s medical needs and condition.

 Ordered and furnished by qualified personnel.

 One that meets, but does not exceed, the patient’s medical need.

 At least as beneficial as an existing and available medically appropriate alternative.

 

• Supervision and Training

o The CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 13.5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) outlines that “reasonable and necessary” services are “ordered and/or furnished by qualified personnel.”

 Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

o A qualified physician for this service is defined as follows: Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty.

o Free standing facilities (office or clinic), hospital based practices and mobile delivery units affiliated with a Place of Service (POS) must meet Federal and local (FL, PR, USVI) radiation protection guidelines in regard to patient safety and quality assurance as well as the Medicare physician supervision requirements.

 For example, regulations require a medical physicist presence for HDR brachytherapy and direct supervision by the Radiation Oncologist.

 For teletherapy, regulations require qualified physician supervision and the presence of a qualified medical physicist.

 It is expected that all personnel involved in administering, supervising, and treating patients for the indications outlined in this LCD meet the regulations set forth for the state of Florida and for Puerto Rico and for the U.S. Virgin Islands as well as Medicare and the Nuclear Regulatory Commission (NRC), as applicable.

 These personnel include the radiation oncologist or other qualified physician, radiation/medical physicist, radiation technologist and radiation assistant.

 These regulations include:

 Chapter 468, Part IV, Florida Statutes and Chapter 64E-3 and 64E-5, Florida Administrative Code

 http://www.myfloridaeh.com/radiation/

 Law # 74 for Puerto Rico

 http://www.lexjuris.com/lexlex/Leyes2008/lexl2008074.htm

 Law # 79 for Puerto Rico

 http://www.salud.gov.pr/Services/SaludRadiologica/Documents/Ley79.pdf

 

 

CPT/HCPCS Codes

 

77401 RADIATION TREATMENT DELIVERY, SUPERFICIAL AND/OR ORTHO VOLTAGE

77402 RADIATION TREATMENT DELIVERY, SINGLE TREATMENT AREA, SINGLE PORT OR PARALLEL OPPOSED PORTS, SIMPLE BLOCKS OR NO BLOCKS; UP TO 5 MEV

77403 RADIATION TREATMENT DELIVERY, SINGLE TREATMENT AREA, SINGLE PORT OR PARALLEL OPPOSED PORTS, SIMPLE BLOCKS OR NO BLOCKS; 6-10 MEV

77404 RADIATION TREATMENT DELIVERY, SINGLE TREATMENT AREA, SINGLE PORT OR PARALLEL OPPOSED PORTS, SIMPLE BLOCKS OR NO BLOCKS; 11-19 MEV

77406 RADIATION TREATMENT DELIVERY, SINGLE TREATMENT AREA, SINGLE PORT OR PARALLEL OPPOSED PORTS, SIMPLE BLOCKS OR NO BLOCKS; 20 MEV OR GREATER

77785 REMOTE AFTERLOADING HIGH DOSE RATE RADIONUCLIDE BRACHYTHERAPY; 1 CHANNEL

77786 REMOTE AFTERLOADING HIGH DOSE RATE RADIONUCLIDE BRACHYTHERAPY; 2-12 CHANNELS

77789 SURFACE APPLICATION OF RADIATION SOURCE

 

 

ICD-9 Codes that Support Medical Necessity

 

140.0 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER

140.1 MALIGNANT NEOPLASM OF LOWER LIP VERMILION BORDER

140.3 MALIGNANT NEOPLASM OF UPPER LIP INNER ASPECT

140.4 MALIGNANT NEOPLASM OF LOWER LIP INNER ASPECT

140.5 MALIGNANT NEOPLASM OF LIP UNSPECIFIED INNER ASPECT

140.6 MALIGNANT NEOPLASM OF COMMISSURE OF LIP

140.8 MALIGNANT NEOPLASM OF OTHER SITES OF LIP

140.9 MALIGNANT NEOPLASM OF LIP UNSPECIFIED VERMILION BORDER

173.01 BASAL CELL CARCINOMA OF SKIN OF LIP

173.02 SQUAMOUS CELL CARCINOMA OF SKIN OF LIP

173.11 BASAL CELL CARCINOMA OF EYELID, INCLUDING CANTHUS

173.12 SQUAMOUS CELL CARCINOMA OF EYELID, INCLUDING CANTHUS

173.21 BASAL CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.22 SQUAMOUS CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.31 BASAL CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.32 SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.51 BASAL CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM

173.52 SQUAMOUS CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM

173.61 BASAL CELL CARCINOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER

173.62 SQUAMOUS CELL CARCINOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER

173.71 BASAL CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP

173.72 SQUAMOUS CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP

173.91 BASAL CELL CARCINOMA OF SKIN, SITE UNSPECIFIED

173.92 SQUAMOUS CELL CARCINOMA OF SKIN, SITE UNSPECIFIED

230.0* CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX

232.0* CARCINOMA IN SITU OF SKIN OF LIP

232.1* CARCINOMA IN SITU OF EYELID INCLUDING CANTHUS

232.2* CARCINOMA IN SITU OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

232.3* CARCINOMA IN SITU OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

232.5* CARCINOMA IN SITU OF SKIN OF TRUNK EXCEPT SCROTUM

232.6* CARCINOMA IN SITU OF SKIN OF UPPER LIMB INCLUDING SHOULDER

232.7* CARCINOMA IN SITU OF SKIN OF LOWER LIMB INCLUDING HIP

232.9* CARCINOMA IN SITU OF SKIN SITE UNSPECIFIED

*May be subject to prepayment medical review

 

Note: The above diagnosis codes only apply when the radiation therapy delivery codes listed in this LCD apply to the treatment of T1 BCC or SCC Carcinomas of the Skin. For the purposes of this LCD the CPT codes listed in the section of the LCD titled “CPT/HCPCS codes”, are appropriate in the treatment of other modalities that are outside the scope or intent of this LCD”.

 

 

Documentation Requirements

• The following documentation must be included in the patient’s medical record and be made available to Medicare upon request:

o History and Physical.

o Any consultation notes.

o Pathology report.

o Physician note that outlines planned process of care for the lesion being treated which will include the planned modality, dose and duration.

o A digital photo of lesion with ruler should be available on request.

o Necessity and frequency of treatment must be supported in the patient's medical record.

o Medical record documentation of the patient’s functional status and a description of current performance status (Eastern Cooperative Oncology Group [ECOG] Performance Scale).

 See the ECOG Performance Scale listed under the Indications and Limitations of Coverage and/or Medical Necessity section of the LCD above.

o The patient’s record demonstrates why EBRT or HDR brachytherapy is considered the treatment of choice for the individual patient.

 Specifically, the record must address the lower risk to normal tissue, the lower risk of disease recurrence, and the advantages of the treatment over destruction or surgery.

 Dosimetric evidence of reduced normal tissue toxicity and/or improved tumor control must be included.

• In addition, it is expected that documentation demonstrating the certification and qualifications required by Federal and State regulations as well as Medicare with regards to training and supervision of all personnel involved in the radiation treatment are maintained and made available to Medicare upon request.

• This LCD includes the radiation treatment delivery codes that are appropriate for the treatment of certain T1 BCC and SCC skin cancers if indications are met.

o Other radiation oncology procedures performed during the episode of care must be consistent with the standard process of care for the radiation therapy of T1 lesions.

o These procedures must be reasonable and necessary for the care of the patient and meet CPT as well as ASTRO/ACR coding guidelines.

o Documentation should support the professional and technical components (as applicable) by identifying the place of service, the date of service, the supervising physician, and the proof of work.

 

Treatment Logic

• There are several treatment options for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin including surgical excision and radiation therapy.

o This local coverage determination (LCD) will focus solely on radiation therapy (RT) for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) stage T1 (see ‘Limitations’ section for statement on Tis lesions). Stage T1 lesions are defined as lesions ≤2 cm.

• Non-melanoma skin cancers (NMSC), also known as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are the most common forms of skin cancer.

o Basal cell carcinoma develops from the deep epidermis skin cells and can most commonly be found on sun exposed areas such as the face, ears, hands and forearms.

o Basal cell carcinomas are generally slow growing.

o Squamous cell carcinoma, like basal cell, typically are found on sun exposed areas of the skin, but can also occur on areas of the skin that have had previous trauma (burns, scars) or areas that have inflammatory conditions.

o Squamous cell carcinoma develops from the middle layer of the epidermis and can be slow or fast growing and can invade surrounding structures.

• External beam radiation therapy (EBRT), also known as teletherapy, is therapy aimed at the lesion/tumor from an x-ray source outside the patients’ body, usually a linear accelerator (“linacs”) which produce X-rays (photons) or electrons.

o Electrons are useful in treating superficial lesions because the dose is aimed at the surface and dissipates as it goes deeper, thus sparring underlying tissue.

o Electrons usually have an energy range from 4-25 MV.

o Therapeutic x-rays (photons) can have energies in the kV range (at least 50 kV or greater) or, more typically, in the MV range.

o EBRT treatment is usually given over a series of daily treatments called fractions that can span over a few weeks (2-9).

o There are several methods used to administer EBRT: conventional, 3D conformal, intensity modulated radiation therapy (IMRT), tomographic, and stereotactic radiosurgery.

• Brachytherapy unlike EBRT administers radiation therapy within or in contact with the body.

o Brachytherapy can be low dose rate (LDR) or high dose rate (HDR).

 LDR involves placing the radiation source directly into or next to the tumor.

 HDR treatment is delivered with dose rates greater than or equal to 1200 cGy per hour.

• The high intensity radio elements used in HDR have a radioactivity level high enough that prevents manual handling and loading of the applicator.

 

Sources of Information and Basis for Decision

 

American Association of Physicists in Medicine.(2010) http://www.aapm.org/medical_physicist/fields.asp#therepeautic

 

The American Society for Therapeutic Radiology and Oncology (ASTRO)/American College of Radiology (ACR) Guide to Radiation Oncology Coding. (2010). American Society of Radiation Oncology and the American College of Radiology.

 

Eastern Cooperative Oncology Group: Performance Scale and corresponding Karnofsky Rating (Cancer Medicine 5th ed).

 

FCSO LCD 31510, Radiation Therapy for T1 Basal Cell and Squamous Cell Carcinomas of the Skin, 10/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Florida Statues Radiological Personnel Certification http://www.myfloridaeh.com/radiation/

 

Law # 79 for Puerto Rico

http://www.salud.gov.pr/Services/SaludRadiologica/Documents/Ley79.pdf

 

Law # 74 for Puerto Rico http://www.lexjuris.com/lexlex/Leyes2008/lexl2008074.htm

 

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology V.1.2010. Basal Cell and Squamous Cell Skin Cancers.

 

Radiation therapy for skin cancer. Accessed through http://www.rtanswers.org/treatmentinformation/cancertypes/skin/types.aspx

 

Radiation therapy for skin cancer. Accessed through http://www.rtanswers.org/treatmentinformation/treatmenttypes/brachytherapy.aspx

 

Radiation therapy for skin cancer. Accessed through http://www.rtanswers.org/treatmentinformation/treatmenttypes/skin/externalbeam.aspx

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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.

 

CMS LCD L31510 Radiation Therapy for T1 Basal Cell and Squamous Cell Carcinomas of the Skin