Hythiam's PROMETA(TM) Protocol for Alcoholism to Be Evaluated towards Third-Party Reimbursement; Third Party Payor Provides Assurances That Standardized Treatment Outcomes Achieved with PROMETA(TM) Will Receive Reimbursement When Verified.
Treatment for alcohol dependency and treatment outcomes vary greatly within third party payor networks and in the general treatment community. While certain providers are able to deliver good treatment outcomes, they can be limited in capacity and outcomes are not often replicable across multiple sites or among large numbers of patients. With healthcare costs associated with untreated alcohol dependency estimated at $175 billion per year, up to 40% of general hospital beds in the United States are occupied by patients under treatment for alcohol-related illnesses. These costs outpace healthcare costs associated with dependency on nicotine and use of other illicit drugs.
"As standardized treatment outcomes are significant for the third party payor community, we feel confident that based upon assurances we have received from Parallax and its third party payor partners, validation in this study will lead toward direct reimbursement for PROMETA(TM) and ultimately, will allow for a solution which they can replicate and scale across their entire networks. If successful, our intent is to leverage these initial results nationwide for use as a template that other managed care providers can rapidly integrate into their networks," said Terren S. Peizer, Hythiam's Chairman and CEO.
Standard treatment outcomes for alcohol dependency may reduce the frequency of other healthcare claims, making pharmacoeconomic studies of treatments like PROMETA(TM), which can be standardized and deployed across multiple providers within a third party payor's network, an ongoing priority of third party insurers.
Commenting on the study, Dr. Ockert said, "We look forward to comparing our current protocol with PROMETA(TM) in order to find a solution that best serves the needs of our patients and managed care providers. If PROMETA(TM) compares favorably, it may offer considerable improvements to the medical aspects of our treatment program and allow us to more rapidly stabilize patients in early abstinence to help them more effectively utilize the behavioral phase of their recovery. We hope to be in a position to offer better outcomes over a greater patient population.
"Also, for our third party payors outcomes are difficult to standardize and replicate across the many treatment centers to which they send patients. If PROMETA(TM) is validated in this study it could represent a welcome solution for managing this disease -- one that may benefit both the treatment providers, as well as their managed care partners."
A total of 60 patients will participate in the study that will be conducted at the Parallax Center. Patients who receive the Parallax treatment will receive none of the medications used in the PROMETA(TM) protocol. Additionally, Antabuse(TM) and Campral(TM), medications that are commonly used to maintain abstinence from alcohol and to prevent relapse, will not be given to PROMETA(TM) patients.
The first 15 patients to be recruited will receive the Parallax treatment protocol, including medications for treatment of psychiatric disorders such as antidepressants along with Antabuse(TM) and Campral(TM). Intensive outpatient aftercare treatment including group and family therapy, psychiatric evaluation, cognitive-behavioral relapse prevention therapy methods, and community-based support programs will be utilized as a part of the Parallax Treatment Protocol. Average length of participation in the Parallax treatment program is 73 days.
The second 30 study participants will receive the PROMETA(TM) protocol along with the same outpatient aftercare provided to those in the Parallax Treatment Protocol group. The last 15 patients will receive the same treatment provided to the first 15 patients. Treatment seeking patients who meet the criteria for alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV), will be candidates eligible for the study. Patients will not be required to be alcohol abstinent prior to the enrollment.
Outcomes to be measured for both treatment protocols over the course of the study will be:
--Self report of alcohol abuse
--Biological markers of alcohol abuse
--Utilization of aftercare treatment services
--Economic outcomes (e.g. pre-treatment cost of utilizing healthcare to deal with adverse effects of alcohol dependency)
--Lost labor costs
--Quality of life outcomes
About David M. Ockert, PhD
David M. Ockert, PhD, is the founder and Executive Director of the Parallax Center in New York City. Dr. Ockert is a trained clinician, researcher and statistician with extensive experience developing and evaluating integrated behavioral and pharmacological treatments. Dr. Ockert has developed and elaborated on methodologies for out-patient detoxification and stabilization from alcohol, opiates, benzodiazepines, stimulants, and other drugs of abuse.
Dr. Ockert was awarded a National Institute of Mental Health (NIMH) Research Training Fellowship for Columbia University. Dr. Ockert has had graduate level teaching appointments at New York University and Columbia University and has lectured at the Center for Alcohol Studies, Rutgers University. He has provided consulting, clinical research, medical and technical advisory services for many organizations and has published six journal articles and four chapters specifically regarding lowered drug use recidivism following psychotropic medication (alcohol, opiates, and stimulants) and most recently co-authored a chapter on the treatment of stimulant dependence for Guilford Press (2004).
About the Parallax Center and the Parallax Treatment Protocol
The Parallax Center is a medically supervised substance abuse treatment program in New York City, operating since 1984. The Office of Alcoholism and Substance Abuse Services of the State of New York licenses two treatment services within the Parallax Center: medically-supervised ambulatory withdrawal services and outpatient chemical dependence treatment services. The Parallax Center treats dependence on alcohol, opiates, stimulants, sedatives/tranquilizers, and all other common substances of abuse.
The treatment uses a coordinated delivery of services to address biological, psychological and social needs during acute withdrawal, stabilization and early recovery periods. In addition to the utilization of pharmaceutical interventions (e.g. Antabuse(TM), Campral(TM)), the Parallax Treatment Protocol also provides individual, group, and family therapy provided by trained counselors and social workers, and psychiatric evaluation and medication management by physicians with addiction and psychiatric expertise. The psychosocial treatment modality of the Parallax Treatment Protocol is a combination of cognitive-behavioral relapse prevention therapy methods and community-based support program attendance.
Hythiam's PROMETA(TM) treatment protocols are designed for use by healthcare providers seeking to treat individuals diagnosed with dependencies to alcohol, cocaine or methamphetamines, as well as combinations of these drugs. The PROMETA(TM) protocols include medically supervised procedures designed to address both the neurochemical imbalances in the brain and some of the nutritional deficits caused or worsened by substance dependence. Changes in brain chemistry and function play an important role in the physical and behavioral symptoms of substance dependence, including tolerance, withdrawal symptoms, craving and relapse. The PROMETA(TM) protocols also provide for one-month of prescription medication and nutritional supplements, combined with psychosocial or other recovery-oriented therapy chosen by the patient in conjunction with their treatment provider. As a result, PROMETA(TM) represents an innovative approach to managing alcohol, cocaine or methamphetamine dependence that is designed to address physiological, nutritional and psychosocial aspects of the disease, and is thereby intended to offer patients an opportunity to achieve sustained recovery.
About Hythiam, Inc.
Hythiam(R) is a healthcare services management company, focused on delivering solutions for those suffering from alcoholism and other substance dependencies. Hythiam researches, develops, licenses and commercializes innovative physiological treatment protocols that seek to address substance dependence. Additionally, Hythiam provides proprietary administrative services to assist physicians and facilities with staff education, marketing and sales support, and outcomes tracking for data analysis. For further information, please visit www.hythiam.com.
Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history and lack of statistically significant formal research studies, the risk that treatment protocols might not be effective, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and substantial regulation in the healthcare industry; and additional risks factors as discussed in the reports filed by the company with the Securities and Exchange Commission, which are available on its website at http://www.sec.gov.
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|Date:||Dec 15, 2005|
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