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Electronic Brachytherapy for Skin Cancer – a Viable Economic Model?

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Superficial Radiotherapy (SRT) for skin cancers is an office based treatment that has become increasingly popular with patients and clinicians. However, it has not been widely adopted by office based practices for reasons of costs and regulations. It appears that electronic brachytherapy offers a viable economic model and greater acceptance at least for the immediate future.

The essence of economic viability resides in the AMA CPT code 0182T. The code is defined as high-dose rate electronic brachytherapy (HDR eBx). Axxent Electronic Brachytherapy System (eBx) initially approved in 2005 was intended to provide brachytherapy when the physician chose to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer. In 2009, the CPT code was assigned New Technology Ambulatory Payment Classification (APC) allowing reimbursement outside the hospital setting. CMS assigned a payment of $770 per fraction given the cost of the Axxent eBx radiation source. Although, the Axxent miniaturized radiation source was initially intended as intraoperative radiation therapy, it was adapted as an external radiation therapy device for skin cancers. The manufacturer, Xoft Inc, then chose to market their device for that purpose but recommended coding it as electronic brachytherapy.

 

Xoft Axxent Controller

Xoft Axxent Controller

Defining Brachytherapy

The word brachytherapy means “short (distance) treatment” – placed on or near the target / tumor. By using the device intended for electronic brachytherapy as an external radiation source, does it make the treatment brachytherapy? Rationale for that exists in the history of brachytherapy. Originally, Iridium radioisotopes were used as radioactive sources for interstitial and contact brachytherapy. Contact brachytherapy, also known as external and surface brachytherapy was used for skin cancers. The radiation source was placed directly on the skin for a period of time. Source-to-skin distance (SSD) of Xoft Axxent device is 25 mm – not quite contact but still short compared with traditional 15 cm of superficial radiotherapy machines (SRT). At what distance then, does the treatment with an x-ray source become brachytherapy? If a lower energy smaller SRT X-ray device is created and it treats at a shorter distance than 15 cm, should it be considered brachytherapy? Nucletron’s Esteya did just that obtaining FDA approval this September. Their device is a nondisposable 70 kV x-ray source (vs Xoft’s 50 kV) located 6 cm from the surface. It is being marketed by Nucletron as brachytherapy.

Xoft Axxent Skin Applicator

Xoft Axxent Skin Applicator

Xoft Axxent HDR X-Ray source

Xoft Axxent HDR X-Ray source

Defining High Dose Rate

Does skin cancer treatment qualify as high dose rate (HDR)? Original approval for Xoft’s Axxent HDR electronic brachytherapy was intended as a single intraoperative intracavitary high dose radiation treatment following lumpectomy. When utilized for skin cancer, standard fractionation schedule is used, with smaller doses delivered over 10 to 15+ fractions – a stretch of the high dose rate (HDR) definition. Historically, low dose radiation has been used in brachytherapy but in a setting of a low-energy decaying isotope implanted permanently into the tumor.

Coding Hurdles

FDA approval of eBX for skin cancer should not be confused as a validation of a coding strategy. 0182T is a code created for eBx with appropriate reimbursement. But is that an appropriate code when used as external radiation therapy for skin? This can be tested in a historical comparison to the use of Cobalt-60 as a source of radiation treatment. Although Cobalt was used in needles for interstitial brachytherapy treatment, when used as an external source in fractionated treatment plans it was defined as external beam radiation therapy. In other words, the source of radiation did not define the nature of radiation delivery. However, the reimbursement level of 0182T reflects the cost of the Xoft Axxent disposable radiation source and appears somewhat justifiable. Nucletron’s Esteya pushes this thought experiment to the extreme – a nondisposable low cost radiation source close to the skin surface – should that be coded as 0182T?

Thus, to code with 0182T, the clinician and coder must be comfortable with two definitions.
1. Fractionation scheme represents a high dose rate.
2. The X-ray source to surface distance represents brachytherapy – short distance.

Esteya

Esteya Electronic Brachytherapy machine

Esteya Electronic Brachytherapy machine

Esteya Electronic Brachytherapy machine

Economic Viability

What cannot be questioned is the economic viability of the high dose rate electronic brachytherapy (0182T) reimbursement by Medicare. It exceeds the superficial radiotherapy coding reimbursement on average by 6 fold. This makes the economic model of electronic brachytherapy very successful in patients 65 and older. Here are the Medicare numbers.

External beam radiation therapy with superficial and orthovoltage energies (Xstrahl 100, Sensus SRT-100) reimburses $27 per fraction. With simulation, treatment planning, supervision, and custom shielding codes, reimbursement up to $2200 per lesion can be achieved, with the simplest treatment at $1300, an average of $2000 per lesion.

High-dose electronic brachytherapy at $770 per fraction, reimburses $8700 – $9500 for a 2 week daily treatment, up to $12,500 for a 3 week treatment, and up to $16,500 for a 4 week treatment.

This level of reimbursement affords generous and legal fee splitting between the treating clinician and the supervising radiation oncologist. This is necessary, because, unlike superficial radiotherapy (Xstrahl 100, Sensus SRT-100), brachytherapy requires radiation oncologist supervision. The supervision removes the challenges of adoption of radiation therapy in skin cancer practices. The barriers of clinical inexperience, physicist management, and licensure and licensure exams (California only) are eliminated with the relationship with the radiation oncologist. The model and its economic viability are the drivers of current eBx popularity.

Superficial Radiotherapy - Xstrahl 100

Superficial Radiotherapy – Xstrahl 100

The Future

Xoft’s eBx was the pioneer of this model. In the future, lower cost x-ray sources will replace this disposable catheter design created for intraoperative tumor bed treatment. Nukletron’s Esteya may have improved on the concept while pushing the limits of brachytherapy definition. But is all this financially viable long term from payors’ perspective? It is widely accepted within the industry that Medicare will end this level of reimbursement at a certain point. Private insurers are not covering eBx under the pretense of investigational / experimental, although it has clearly been shown as safe and effective in the literature. Of course, if private insurers decide to cover eBx for skin cancer, it will likely be at SRT reimbursement rates and not at brachytherapy rates.

The most exciting aspect of this technology is wider acceptance of superficial radiotherapy for skin cancers by dermatologist. It has been long coming since the days of radiation machines in many dermatology offices in the 1970’s. This wider acceptance will also drive technological innovations such as miniaturization of X-ray emitters. Even if and when CMS will judge the current electronic brachytherapy coding strategy as defunct, the awareness of radiation treatment for skin cancers among clinicians and patients will remain. And that is a good thing.

References

CMS 0182T Definition

American Society for Radiation Oncology brachytherapy definition

Aetna website electronic brachytherapy policy

Health Net website electronic brachytherapy policy


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