Q: We are a new ASC interested in offering prostate brachytherapy. What are the regulatory requirements/logistics behind offering it? What are the support staff requirements? Do our nurses and staff members need extra radiation-related training?
Randy Whaley: There are several areas you will need to address before you can and should perform prostate brachytherapy in your center.
1. RAM license. You will need a radioactive materials (RAM) license. That submission is a rather healthy document that needs to be submitted to the state. It can take 90-120 days to navigate through the regulatory pathway of the state submission process for a radioactive materials license. You should prepare the submission under the direction and supervision of a radiation oncologist (radonc) and medical physicist to make sure your documentation is complete, accurate and thorough; this submission should comply to state regulations and document your quality assurance and policy and procedure processes of your program.
2. Radiation training. You have to deploy a radiation safety training program for your staff. There are specific ingredients that the state is going to look for but these are specific to the state. It is recommended that you work with a radonc and a medical physicist that is familiar with your state regulatory requirements.
3. Storage area. You have to be prepared to identify and secure a safe storage area for the radioisotope delivered to your center. While this doesn’t require major shielding,, most states will expect a secured area for the receipt of the isotope and for its storage until use.
4. Necessary staff. Your medical team will likely consist of a radonc, medical physicist, urologist and, in some cases, an ultrasound technologist. Sometimes the radonc and medical physicist will elect to run the ultrasound equipment and will not want an ultrasound tech, but in a lot of cases an ultrasound tech can offer extra value and make for a more efficient implantation.
5. Anesthesia. For most prostate brachytherapy cases (about 80-90 percent), a spinal is usually performed; general anesthesia is not often required.
6. Capital equipment. You’re going to need some major capital equipment. You’re going to need an ultrasound machine, all of the radiotherapy measuring devices such as calibration devices, shielding and loading apparatuses. You’re going to need dwell meters to be able to take a survey of the room and the local implant environment to make sure a radioactive element has not hit the floor and is hidden somewhere.
Since the brachytherapy implants are delivered through ultrasonic guidance; you’re probably looking at $150,000 worth of capital and you’re also going to have to have treatment planning software and hardware so that the medical physicist can prepare the treatment plan. The radonc will endorse the treatment plan after the medical physicist has prepared it.
7. Billing and coding. Billing and coding is also another important factor to address when considering adding prostate brachytherapy. It’s a complex billing methodology. Where most procedures involve just a few CPT codes, for prostate brachytherapy there’s multiple codes that break out in treatment sequences — pre-implant planning to day-of implant to post-implant dosimetry. This is done to verify that there was a good coverage and measures the quality of the implant against the prescribed dose.
The coding and billing is probably going to be much more difficult than anything most centers have done before. You’re going to have to rely on a person in your center that’s either really proficient at billing and coding or outsource this work to a company that specializes in radiation oncology billing.
Note: Read about the 2008 ASC coding changes for prostate brachytherapy.
Additional resources
For additional prostate brachytherapy resources, visit the following Web sites.
- www.theraseed.com
- www.americanbrachytherapy.org
- www.rtanswers.org
- www.oncura.com/prostate-brachytherapy.html
— Randy Whaley is director of business development for United Medical Systems, a mobile services company that has recently announced the launching of a “turnkey” brachytherapy program for ASCs in selected areas of the country. Contact Mr. Whaley at rwhaley@ums-usa.com . Learn more about United Medical Systems by visiting www.ums-usa.com.
