UHMS Announces a Cost-Effectiveness Study of HBO2 for Radiation-Induced Cystitis and Proctitis
In July 2018, a working group with members from two committees of the Undersea and Hyperbaric Medical Society (UHMS) initiated a cooperative study with Dobson DaVanzo & Associates, LLC, to carry out an investigation of the cost effectiveness of HBO2 when applied as a treatment for radiation-induced cystitis and proctitis.
“Dobson and DaVanzo (D&D) is a health economics and policy consulting firm based in Vienna, Virginia, with an impressive track record in providing consulting services to groups conducting medical research, especially when the intent is to access and analyze large databases,” noted Dr. John Feldmeier, co-chair of the UHMS Research Committee. “These consultants have already purchased access to CMS records from 2012 to 2017, which we will employ in accomplishing the study,” he added. The study is being funded through an unrestricted grant from Healogics, Inc.
Who & What
The UHMS working group is composed of Drs. John Feldmeier and John Kirby, co-chairs of the UHMS Research Committee, and Drs. Helen Gelly, Marc Robins and Caroline Fife of the Quality, Utilization, Authorization and Reimbursement Committee.
“It was our QUARC colleagues who brought forward the concept of employing CMS data to complete a cost-effectiveness review of hyperbaric oxygen treatments for late tissue damage from radiation,” said Feldmeier.
The initial thrust was to investigate mandibular radiation necrosis treatment and prevention. Ultimately, however, the working group concurred that radiation injuries to the bladder and rectum would be the best objects of this study design.
Access to Data
The rationale for this choice includes the fact that many patients with mandibular osteoradionecrosis have an oral surgeon as the managing clinician. “We were concerned that many of the charges would not be accessible in the CMS database because if care was provided by a dental specialist, some costs may not be submitted to Medicare,” noted Feldmeier. Charges could be submitted to dental insurance providers or be cash billings.
“Also, we felt that we would have more success in stratifying and matching patients according to the severity of their radiation injuries for bladder and rectum by identifying procedural and surgical interventions commonly applied to these injuries,” said Feldmeier. One of the obvious restrictions of using CMS billing data is that the corresponding medical records are not available because of HIPAA restrictions.
Refining the Process
This working group, along with consultants from D&D, have met on a regular basis since July 2018. The biggest challenge they have reported has been to develop surrogate measures of severity for patients in both the hyperbaric-treated group and non-hyperbaric group to ensure that both cohorts of patients comprised patients with comparable severity. The dilemma, Feldmeier notes, is how to match these comparative groups without access to the clinical records. However, by stratifying both groups using billing codes that indicate interventions consistent with severe radiation injury, the team can more readily identify those patients who are intended to be the object of the study.
Both radiation-induced cystitis or proctitis vary significantly in the severity of involvement. A single episode of blood in the stool or urine after radiation therapy might be coded as radiation proctitis or cystitis but would likely progress to complete resolution spontaneously or with minimal intervention. The team’s intent is to compare two groups of patients who have a substantial injury that is likely to progress without effective therapy. The approach will be to restrict the study to patients who require interventions such as frequent transfusion or a surgical corrective procedure indicative of the severity of their injury.
The team’s expectation is that this study will be presented at next year’s annual meeting in Puerto Rico, with publication in a peer-reviewed journal shortly thereafter.
“Those of us who have treated radiation injuries with hyperbaric oxygen have seen consistent dramatic clinical response,” said Feldmeier. “If we can make the case that hyperbaric oxygen is not only an effective clinical intervention but also effective in reducing the cost of managing these difficult disorders, we believe that CMS and other third-party payors will take note of the cost savings and readily approve hyperbaric oxygen as appropriate for patients suffering from serious manifestations of radiation-induced rectal or bladder damage.”
— Based on an original UHMS article in by Dr. John Feldmeier at: https://www.uhms.org/publications/pressure/fourth-quarter-pressure-2018/viewdocument.html