Proton Beam Radiation Therapy denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) proton beam therapy given as 70 Gy in 28 fractions and (2) hydrogel spacer. Proton beam has unique properties compared to standard photon or x-ray beam in its ability to deposit radiation doses. The use of proton beams potentially results in fewer areas of low scattered radiation dose as fewer proton beams may be used to achieve a dose distribution similar to standard photon beams. Proton therapy is currently utilized and strongly indicated in settings where severe toxicities would result if normal tissue constraints cannot be met by photon beam. However, in the setting of early stage prostate cancer there has not been a demonstrable clinically significant improvement in either quality of life or reduction of high grade toxicities.

Findings: The physician reviewer found that The patient has requested authorization and coverage for proton beam therapy, transperineal placement of a hydrogel spacer, special medical radiation physics consultation, special treatment procedure, and/or guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed. On review of the current peer-reviewed medical literature and guidelines, the requested proton beam radiation therapy is not supported as medically necessary for treatment of this patient. The records provided for review document that this patient was appropriately referred to undergo a course of definitive radiation treatment for this favorable intermediate risk prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines.

Where the denial was upheld

Physician 1: The patient is a 50-year-old woman diagnosed with papillary thyroid cancer in July 1998. She underwent thyroidectomy followed by 150 mCi of iodine-131. A PET scan performed in December 2000 showed persistent disease. In January 2001, the patient underwent bilateral neck dissection followed by a second course of iodine-131 therapy, presumably 150 mCi. An MRI performed in October 2003 revealed a 2x 2.3 x 1.5 cm mass in the right inferior neck. In January 2004, the patient underwent a modified neck dissection and paratracheal mass excision. Post-operatively, the patient received 315 mCi of iodine-131. She was then referred for post-operative external beam irradiation, but it is not known if this took place. In January 2005, a follow-up PET scan was negative for any disease. It appears she has received 600 mCi of iodine-131 to date.

Physician 1: The patient is a 52-year-old male diagnosed with adenocarcinoma of the prostate, Gleason grade 3+3=6/10, PSA 16.8, and clinical stage T1c, based on the August 2006 consultation. Two of four cores from the right side of the prostate were positive involving 10% to 12% of the biopsy specimen. The pathology report did not indicate any other conditions such as benign prostatic hypertrophy (BPH) or chronic prostatitis. The metastatic workup included an MRI scan, bone scan, and CT scan of the pelvis with contrast. All were negative for evidence of metastatic disease. The consulting radiation oncologist recommended the combined treatment of photon and proton radiation.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Proton Beam Radiation Therapy, then check the rights and deadlines that apply to your plan.