History of the project
The 2014 Florida Legislature appropriated $1 million in recurring General Revenue funds and $2 million in non-recurring funds to provide extended-release injectable naltrexone (VIVITROL®) to treat alcohol and opioid addicted offenders in community-based drug treatment programs. These funds were appropriated to the Office of the State Court Administrator (OSCA) who has contracted with the Florida Alcohol and Drug Abuse Association (FADAA) to establish a program enabling providers to access this medication. With dedicated resources made available by the Legislature to access this medication, there is an opportunity for providers to expand their clinical and medical protocols to use VIVITROL. FADAA has established a grant process for the selection of eligible providers and for the allocation and distribution of the funds.
From 2006 to 2008, FADAA in collaboration and under contract with the Florida Department of Children and Families, participated in a national initiative, the Advancing Recovery Grant, funded by the Robert Wood Johnson Foundation to increase the effective use of evidence-based practices (EBP), specifically medication-assisted treatment with VIVITROL. FADAA's role in this effort was three-fold:
- Identify and engage a specific number of providers to participate in the pilot;
- Organize and facilitate delivery of provider training on client selection, provider capacity requirements for participation, administration of the medication and developing a utilization and outcome tracking system; and,
- In conjunction with the Department, monitor the status of the project including identifying and remediating any local or state barriers to service delivery and to develop the infrastructure needed to implement the utilization of VIVITROL, such as identifying funding alternatives for the medication, including the use of the Indigent Drug Program.
The RWJ funded initiative resulted in positive client results, the creation of guidelines to approve provider agencies to access medications through the State Pharmacy, the development of procedures for medication purchase, and processes for identifying provider capacity to administer medication-assisted treatment. Subsequent to the end of the RWJ funded project, FADAA continued to work to sustain the use of VIVITROL with providers who participated in the RWJ pilot and to encourage the use of VIVITROL to additional providers. By 2009, the number of providers participating in the VIVITROL initiative increased by 50%.
For the past several years FADAA has been working with the Department of Corrections to establish a program to utilize VIVITROL for probationers in community drug treatment secure and non-secure residential treatment programs. FADAA worked with the Department of Corrections in developing a protocol to select providers that had the medical capacity to implement the program. With dedicated funding this past legislative session, FADAA is presently working with the Department to expand the number of providers utilizing the medication.
In addition, FADAA has been working with the Department of Children and Families to expand the number of providers utilizing the medication. In 2013, with FADAA's help in recruiting additional providers, the DCF doubled the number of providers utilizing this medication.
What is VIVITROL®?
Naltrexone is a non-addictive antagonist used in the treatment of opioid and alcohol dependence. As an antagonist, naltrexone does not mimic the effects of opioids. It simply blocks opioid receptor sites so that other substances present in a patient's system cannot bind to them. Naltrexone administered in an injectable long-acting formulation is marketed under the brand name of VIVITROL®) which is designed for once-monthly dosing. The U.S. Food and Drug Administration (FDA) approved this medication for use in individuals with opioid or alcohol use disorders to prevent relapse.
Naltrexone for alcohol dependence
As a non-addictive antagonist naltrexone is used to block opioid receptors so they cannot be activated. In people with alcohol dependence, it is believed that this blockade (opioid antagonism) diminishes craving for alcohol and leads to a greater ability to resist urges to drink excessively. Naltrexone is available in two forms: oral daily form (ReVia®, Depade®) and injectable monthly extended-release form (VIVITROL®). The later was approved by FDA for treatment of alcohol dependence in 2006.
Although the mechanism responsible for the reduction in alcohol consumption observed with treatment is not entirely understood, preclinical data suggests that occupation of the opioid receptors results in the blockade of the neurotransmitters in the brain that are believed to be involved with alcohol dependence. This blockade may result in the reduction in alcohol consumption observed in patients treated with naltrexone. (Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence. TIP 49, Chapter 4 (Oral Naltrexone), Chapter 5 (IM), SAMHSA.)
Naltrexone for opioid dependence
Naltrexone is a non-opioid medication that is approved for the treatment of opioid dependence. As an opioid receptor antagonist, naltrexone binds to opioid receptors, but instead of activating the receptors, it effectively blocks them. Through this action, it prevents opioid receptors from being activated by agonist compounds, such as heroin or prescription pain killers, and is reported to reduce craving and prevent relapse. As opposed to other medications used for opioid dependence (methadone and buprenorphine), naltrexone can be prescribed by any individual who is licensed to prescribe medicine (e.g., physician, doctor of osteopathic medicine, physician assistant, and nurse practitioner). Both the oral daily form and the monthly injectable monthly extended-release form (VIVITROL®) are FDA approved for treatment of opioid dependence. VIVITROL® was approved by FDA for this indication in 2010.
VIVITROL is the only extended-release medication approved by the FDA for this purpose. It is used by the Department of Veterans Affairs and is being utilized by numerous justice agencies across the country including the Departments of Corrections in California, Colorado, Florida, Missouri, and Pennsylvania and numerous jail systems including Los Angeles County and New York City at Riker's Island.
How does a provider enroll in this program?
Providers interested in participating in this project should first review the criteria for participation.
There is an on-line application available on FADAA's website which will need to be submitted along with your medical protocol or indication that you will use FADAA's medical protocol in the application. FADAA's sample medical protocol can be found on our website at the following URL: http://www.fadaa.org/vivitrol/documents/VivitrolProtocolDRG.pdf
After the application is completed, it can be submitted electronically and will be reviewed by FADAA. When the application is approved, the provider will receive a Memorandum of Agreement (MOA) with FADAA. You can review a sample of the agreement here.
The Agency Director must sign the agreement and return it to FADAA for signature by the CEO of FADAA. The agreement is not final until signed by both parties.
Providers will also need to establish a business credit account with Besse Medical, the specialty pharmacy that is providing the drug for agencies enrolled in this project. There is an on-line application at http://businessapplication.besse.com/ which can be submitted electronically or completed and faxed to Besse at (1-888-375-0030). You will be notified within 48 hours and will receive a Besse account number. You will also need to complete an Uninsured Provider Certification form and submit it to Alkermes.
On the provider certification form, please be sure to include your Besse account number and be sure the DEA number on the certification form matches the DEA number on the Besse account. The form should be faxed to (1-952-513-4826).
After the agreement is final and your account is established you will be able to enroll participants in the program.
Who is a good candidate for the program?
- Alcohol dependent patients
- Opioid dependent patients
- Leaving jail or prison
- Probationers and parolees
- Young adults ages 18-25
- Healthcare professionals
- Severe alcohol dependent patients
- Severe opioid dependent patients
- Patients with private insurance
- Patients with public coverage
- Patients preparing to leave rehabilitation
- Individuals leaving detox and those leaving detox at high relapse risk
- Unable to receive or not appropriate for agonist medications or unwilling to use agonist medications
- Not stabilizing on methadone or buprenorphine treatment
- Both alcohol and opioid dependent
Citation: Medication-Assisted Treatment for Substance Use Disorders:
Extended-Release Naltrexone (XR_NTX; VIVITROL®, Webinar, David R. Gastfriend M.D.,
Reimbursement from FADAA for VIVITROL Purchased From Besse
Once you have established a credit account with Besse Medical and have purchased and administered the medication to clients, you will need to submit invoices to FADAA to be paid for the medication and services included in the bundled rate. FADAA will reimburse providers monthly for the costs of the medication, screening and education, medical assessment, and medication support for clients served the previous month. Costs are calculated using the following bundled rate:
- Naltrexone Screening/Medication Education - Unit Price $150
- Naltrexone Assessment (Physical Examination, Lab Work) - Unit Price $540
- Administration of Medication (Medication Management, Medication Administration, Lab Work, and Medication) - Unit Price $1,331
Providers should submit an invoice to FADAA at the following address:
Florida Alcohol and Drug Abuse Association
2868 Mahan Drive, Suite 1
Tallahassee, FL 32308
ATTN: Angie Durbin
The invoice must contain the following information. (Sample invoice)
- Agency Name
- Agency Address
- Contract Number
- Project Title: Extended-Release Injectable Naltrexone
- Invoice Number
- Dates of Service
- Service Provided
- Number of Clients
- Number of Units
- Unit Cost and Total Amount of Each Unit
- Total Clients Served
- Total Amount Billed
Data Collection Requirements
As agreed to in the MOA with FADAA, providers are required to submit monthly program reports. The data required by these reports will be aggregated by FADAA, submitted to OSCA, and will serve as documentation for continued funding. A web-based data reporting and analysis system is in development and should be deployed by April 1, 2015. Providers must assign each client a unique, de-identified client number for reporting purposes.
Required data elements are:
- Monthly medication inventory reports for VIVITROL including number of doses on hand at the beginning of each month(-)less the number administered (+)plus the number received from the designated specialty pharmacy (=)equals the number of doses on hand at the end of the month;
- Monthly client data program activity and outcomes. Data will include, but may not be limited to:
- Number of clients screened and educated on the use, benefits, and risks of extended-release injectable naltrexone;
- Number of clients assessed (received physical exam and/or lab work) for use of extended-release injectable naltrexone;
- Number of clients who received one or more doses of extended-release injectable naltrexone;
- Number of clients screened, educated, and/or assessed who did not receive one or more doses of extended-release injectable naltrexone and reason for not receiving.
- At the provider level only: Demographics of individuals served (first, middle, and last name; date of birth; race; ethnicity; gender; social security number; state identification number; Florida Department of Corrections number, if applicable; county with court jurisdiction of case; current charge(s); court case number; type of problem-solving court, if applicable; alcohol or opioid as drug of choice; and current treatment modality, including outpatient, inpatient, and/or aftercare. This data must be aggregated by the provider before it is submitted to FADAA.
- Client outcomes including, urge to drink and/or use opiates; number days in the month that client drank or used opiates; number of admissions to inpatient treatment; number of days client participated in treatment (treatment retention); increase or decrease in observed or reported symptoms; and changes in social and occupational functioning.
- Number of clients who received at least one dose of extended-release injectable naltrexone and completed the prescribed course of treatment with the total number of doses received by client.
- Number of clients who received at least one dose of extended-release injectable naltrexone and did not complete the prescribed course of treatment with the total number of doses received by client.
- Average number of doses for alcohol users and average number of doses for opioid users
- The annual number of offender treatment referrals you anticipate receiving from the local court system and an estimate of the projected number of these individuals who would be appropriate for medication-assisted treatment using VIVITROL.