The SAVI SCOUT surgical guidance system has been adopted by hospitals throughout the country. Brought to you by the same team behind the SAVI brachytherapy applicator, SCOUT
®
 is a FDA-cleared medical device used to provide tumor localization and real-time guidance during breast surgery. 
 
 
If you would like to be kept up to date on the latest information and updates regarding SCOUT, including details on clinical experience and product availability, you are invited
 to join the SCOUT Report® community.
 
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June 2016 

Brachytherapy Clinical Evidence Update
New data presented at the ESTRO 35 meeting in Turin, Italy further reinforces treatment as a valid alternative to whole breast irradiation in patients with early breast cancer.
 
Clinical equivalence of accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) has already been demonstrated in a multicenter phase III randomized trial:
  • The Groupe Européen de Curiethérapie European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) trial administered APBI with multicatheter interstitial brachytherapy (published in the Lancet in October 2015).
The primary objective of the GEC-ESTRO trial was to assess the role of APBI brachytherapy alone compared to WBI with boost in a defined group of patients with invasive (stage I-IIA) breast cancer or ductal carcinoma in situ (DCIS; stage 0) who underwent breast-conserving surgery. Researchers evaluated a total of 1,184 patients aged 40 years and above who were randomized to a standardized treatment arm (WBI, n=551) or an investigational treatment arm (APBI, n=633). The median follow up in the study was 6.6 years.
Previously published findings from the study demonstrate that APBI with multicatheter interstitial brachytherapy has an equivalent rate of overall survival, disease-free survival and local and regional cancer control as compared to traditional WBI with boost after breast conserving surgery for selected patients with stage 0-II breast cancer. At five-year follow-up, cumulative recurrence rates for WBI and APBI were 1.44% and 0.92% (p=0.42) respectively. Five-year overall survival was 95.55% with WBI versus 97.27% for APBI and a low incidence of all serious late side effects (around 3% in both arms) was noted.
Additional insights from the GEC-ESTRO Trial focus on toxicities and cosmesis
The new data, presented at ESTRO 35 by Prof. Csaba Polgár, MD, PhD, MSc, Professor and Head of the Radiotherapy Center at the National Institute of Oncology in Budapest, Hungary, and co-lead study author, provide additional insights into the late side effect and cosmetic results. Among the 1,184 original study patients, five-year follow-up records on late toxicities and cosmetic results were available for 969 patients (82%).
The five-year toxicity profile was similar for patients treated with brachytherapy or conventional WBI with tumor bed boost. However, a trend towards fewer late skin side effects and better cosmetic results was observed in the APBI arm.
Key Findings
The cumulative incidence of grade 2-3 late skin toxicity at five years was 5.7% with WBI vs 3.2% with APBI (p=0.08).
The cumulative risk of grade 2-3 late subcutaneous tissue effects at five years was 6.3% with WBI vs 7.6% with APBI (p=0.53).
The cumulative incidence of severe (grade 3) fibrosis at five years was 0.2% with WBI and 0% with APBI (p=0.46).
The cumulative incidence of grade 2-3 breast pain was low in both the WBI and APBI arms (3.2% vs 1.4% (p=0.04).
The rate of excellent/good cosmetic results judged by patients was 87.2% with WBI vs 90.4% with APBI ,and 86.7% with WBI vs 88.2% with APBI (p=0.07) when scored by physicians. However, significantly more patients (43.6% vs 30.9%; p=00002) experienced excellent cosmetic results after APBI.

 


The data from the GEC-ESTRO trial further validates the established and growing body of clinical evidence supporting APBI with multicatheter interstitial brachytherapy as a safe and effective alternative to WBI. According to Prof. Polgár, “The convenience of this five-day treatment, coupled with excellent cosmetic outcomes, make this a very attractive treatment option for women with early breast cancer.”

Brachytherapy Reimbursement Changes for 2016: 
Payment values remain level despite coding changes

In 2016, the Centers for Medicare & Medicaid Services (CMS) issued several changes for breast brachytherapy procedure coding. According to Kathy Francisco, managing partner and owner of The Pinnacle Health Group, one of the nation’s leading reimbursement consulting groups, the changes signal “a growing shift toward more procedure packaging or bundling.”

For 2016, the list of radiation oncology coding changes primarily involves bundling basic dosimetry calculations into other procedure codes. For breast brachytherapy, code 77300 (basic radiation dosimetry calculation) can no longer be reported separately with HDR brachytherapy codes.

According to Francisco, payment levels haven’t changed significantly for any of the HDR therapies; nonetheless it’s important to make sure the correct codes are used to avoid reimbursement delays. CMS estimates that the overall effect of the 2016 changes to the Medicare Physician Fee Schedule will be 1 – 2% for radiation oncology practices and radiation therapy centers.

Reimbursement Comparisons

Breast brachytherapy procedures provide appropriate and adequate reimbursement for both the radiation oncologist and the surgeon. Other patient treatment options are radiation oncology-focused only; the surgeon receives no reimbursement, nor are they involved in the ongoing patient radiation following surgery.

For hospital-based radiation oncology departments, HDR brachytherapy offers an average Medicare reimbursement of $11,000 for a five-day treatment protocol. This is compared to $11,000 for standard whole breast radiation (seven weeks of treatment), $6,500 for hypofractionated whole breast irradiation (HF-WBI) (three weeks of treatment), and $7,500 for intraoperative radiation therapy (IORT) including the surgical procedure (single treatment fraction in the OR).

In the freestanding environment, average Medicare reimbursement for HDR brachytherapy $8,400 for a 5 day treatment, while standard seven-week whole breast radiation is approximately $18,000, and 3 week HF-WBI ($8,000).

“Physicians are being rewarded for providing more quality care to their patients,” says Francisco. “For many patients, brachytherapy is the best clinical option available. When comparing modalities, the reimbursement for five days of treatment [for brachytherapy] versus several weeks of treatment [for WBI] is greater per fraction than other treatments. We’re fortunate that this clinical decision continues to be supported with appropriate and adequate reimbursement.”

Key HDR brachytherapy procedure code changes effective Jan. 1, 2016

Three new codes for afterloading high dose rate radionuclide brachytherapy (CPT 77770-77772) replaced CPT codes 77785-77787. The new codes include basic dosimetry (dose calculation), so they cannot be reported with CPT 77300 (Basic radiation dosimetry calculation).

  • Report CPT 77770 for high-dose-rate radionuclide brachytherapy with the radioactive material placed within the lesion or diseased tissue (interstitial) or within a hollow organ (intracavitary) and remote afterloading using a single channel; the procedure includes basic dosimetry (dose calculation) when performed.
  • Report CPT 77771 for high-dose-rate radionuclide brachytherapy with the radioactive material placed within the lesion or diseased tissue (interstitial) or within a hollow organ (intracavitary) and remote afterloading using 2-12 channels; the procedure includes basic dosimetry (dose calculation) when performed.
  • Report CPT 77772 for high-dose-rate radionuclide brachytherapy with the radioactive material placed within the lesion or diseased tissue (interstitial) or within a hollow organ (intracavitary) and remote afterloading using more than 12 channels; the procedure includes basic dosimetry (dose calculation) when performed.