Meeting the Challenges of Office-Based Opioid Treatment, For The Issues You Face Daily ...

We Stand by Your Commitment to Safe, High Quality Care

We Provide the Support You and Your Patients Can Count On

You Focus on Quality Patient Care and Safety ...

Others Manage the Insurance, the Billing and the Costs





WHO WE ARE  

WHY A SAFETY PROGRAM  

WHY LABORATORY TESTING  

WHY YOU NEED A BUPRENORPHINE SAFETY PROGRAM  

HOW TO GET STARTED  

WHAT THE ALETHEIA BUPRENORPHINE SAFETY PROGRAM OFFERS  

CUSTOMER SERVICE  







WHO WE ARE  

Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program

Our company was founded by a group of experts in medication-assisted substance abuse treatment, clinical laboratory testing and toxicology. We have a proven track record of successful implementation of clinical and laboratory programming.

OUR MISSION IS YOUR MISSION:

To minimize the patient, practice and community risks associated with office-based opioid treatment and opioid abuse/dependence.

OUR GOALS ARE YOUR GOALS:





WHY A SAFETY PROGRAM?   

Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program







RISKS TO PATIENTS AND PROVIDERS ARE REAL

"Buprenorphine is an effective treatment for opioid dependence but can be misused and diverted, causing potential risk to patients and the public."



- Judith Martin, MD, American Society for Addiction Medicine (ASAM) Physician Clinical Support System-Buprenorphine (PCCS-B) Mentor Program (2)



"Chad liked to drink. That was his thing," said his father, Art Bessette. "But when he had to work, he'd get up and go right to work." But on the morning of April 23, 2006, after a night of heavy drinking at a bachelor party, Bessette didn't wake up.

The medical examiner initially found in Bessette's body a high level of alcohol and a muscle relaxer, cyclobenzaprine, but did not determine a cause of death. After learning from Bessette's family that he had taken someone's buprenorphine pill that night, the examiner ordered a test that detected the substance. Bessette died from "acute intoxication - combined effects of ethanol, Cyclobenzaprine (Flexeril) and Buprenorphine," the death certificate reads."


From The Bupe Fix. Fred Schulte and Doug Donovan. The Baltimore Sun December 16, 2007 (1)




"In buprenorphine treatment, appropriate tests for illicit drug use should be administered as part of patient assessment ...

... Initial and ongoing drug screening should be used to detect or confirm the recent use of drugs (e.g., alcohol, benzodiazepines, barbiturates) that could complicate management of a patient on buprenorphine."



- CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40 (9)



In the Center for Substance Abuse Treatment's (CSAT) 2006 Assessment of Emerging Indicators of Abuse and Diversion of Buprenorphine (3), experts speculated:





"... the largest part of the diverted drug supply likely comes from buprenorphine prescribed by physicians - either for addiction or for pain ... "

* * *

"For six hours, they combed through his records, seizing 72 patient charts and confiscating his drug-dispensing permit. The charge? "



"None so far, but the assumption is that he is suspected of improperly prescribing narcotic drugs. Despite a distinguished professional record spanning more than four decades, Nelson has had to spend $20,000 on lawyers, fearing that the government will indict him if it turns out that one of his patients has misused his medicine. "



"'My practice is sunk,' says the physician ... "


- Time Magazine-Canada reported on July 25, 2005 "Why Is The DEA Hounding This Doctor?" (5)




WHY LABORATORY TESTING?   



"In buprenorphine treatment, appropriate tests for illicit drug use should be administered as part of patient assessment ...

... Initial and ongoing drug screening should be used to detect or confirm the recent use of drugs (e.g., alcohol, benzodiazepines, barbiturates) that could complicate management of a patient on buprenorphine."




- CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40 (9)



Even When Point of Care Testing is Done ...

A Confirmatory Test is Necessary












"A negative test does not necessarily mean that the patient is not using an opioid.

It may mean that the patient has not used an opioid within a period of time sufficient to produce measurable metabolic products or that the patient was not using the drug for which he or she was tested.

Thus, as with any patient, the physician is alerted to a spectrum of possibilities and works with the patient using the information collected from the toxicology screen."



- CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40 (10)






WHY YOU NEED A BUPRENORPHINE SAFETY PROGRAM ...   
THE PROVIDER ROLE IN MINIMIZING RISK


Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program



"45% of physicians report knowing of diverted buprenorphine

11% of physicians know of "doctor shopping" to obtain buprenorphine

Physician impressions of diverted buprenorphine related to:"



- Elinore F. McCance Katz, M.D., Ph.D., Professor of Psychiatry UCSF and President, American Academy of Addiction Psychiatry
�Emerging Clinical Challenges in Prescribing Buprenorphine, � - citation of a Surveillance Report on Emerging Issues from CRS Associates - December 2007 (8)


"Physicians who prescribe or dispense buprenorphine or buprenorphine/naloxone should monitor for diversion of the medications."



- CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP)




HOW TO GET STARTED   

    Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program





CALL CUSTOMER SERVICE at 866-476-7776

to arrange for a Safety Liaison to visit your office OR

COMPLETE the Visit Request Form Below

Practice Name:
Contact Person:
Phone:
Street Address:
City:
State:
Zip:
Email Address:
   
Best Day to Call/Visit (M-F):
 




Your Laboratory Options   

Aletheia’ s Buprenorphine Safety Program offers a choice of three different Laboratory Testing Options. All of these have the capability to obtain in-office Rapid Results™ and confirmations. Your practice can tailor the testing approach to your clinical preferences, patient population, insurance demographics, staffing and business model to meet your clinical and business goals. More than one testing option and collection method can be offered simultaneously in your office.

Aletheia’ s program is unique in that it offers a choice of Laboratory Partner – You can choose the Laboratory Partner that best fits your practice needs, rather than adjusting your testing program to match one laboratory’s offerings.

Laboratory Costs Your office will do no billing for services provided by your Lab Partner. Third (3rd) party billing for services provided by your Buprenorphine Safety Program Laboratory Partner will be provided at no cost to you. - Claims/bills will be submitted directly to Medicare, Medicaid, commercial insurance plans and to self-pay patients. Patient Assistance A Patent Assistance Program is available within the Buprenorphine Safety Program to help those patients in financial need meet the laboratory testing requirements of the practices where they receive their treatment. Your Buprenorphine Safety Program Liaison and Customer Service will assist with access to the necessary forms to apply for assistance.


WHAT THE ALETHEIA BUPRENORPHINE SAFETY PROGRAM OFFERS   

Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program

Our safety program is designed to incorporate many of recommended measures to minimize misuse, abuse and diversion of buprenorphine as outlined by

The Center for Substance Abuse Treatment (CSAT) Final Report on the Abuse and Diversion of Buprenorphine - 2006

ENROLLMENT IN A DEDICATED BUPRENORPHINE SAFETY PROGRAM BRINGS SO MUCH MORE TO OFFICE- BASED OPIOID TREATMENT THAN TESTING ALONE… Outreach to the patients who are right for your practice Help identifying and engaging those in your general practice who might benefit from buprenorphine treatment *NOTE: These items are all recommendations from Diversion and Abuse of Buprenorphine: A Brief Assessment of Emerging Indicators Final Report Submitted to the Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment Division of Pharmacologic Therapies November 30, 2006



State-of-the-Art Testing with:

• Point of Contact Rapid Results Testing
• Prompt Confirmation



Buprenorphine Treatment Experts:

• Clinical Case Consultation
• Practice Management
• Updated Information



Medical Review Officer & Expert Toxicologists:

• To Assist You with Interpretation of Results
• Translating the Science to Patient Care Effectively



Focus on Your Practice Priorities:

• Access Collector Services when testing work volume starts to detract from best practice



Easy Monitoring and Management from Your Secure, HIPAA-Compliant Web Site:

• Test Results and Trends
• Appointments and Adherence
• Practice Tools and more ...



The Advantage of External Support to Ensure Safety and Adherence with Assisted Connection to:

• External Monitoring Program (where available)
• Your Local Treatment Advocacy Network



A Dedicated Buprenorphine Safety Liaison will work with your practice to identify opportunities to:

• Enhance Buprenorphine Safety
• Simplify the Risk Minimization Process



Education & Training

There are no fees associated with the training necessary to implement the components of the Aletheia Buprenorphine Safety Program provided by Buprenorphine Safety Liaisons. Some additional third party education and training (as recommended or as desired) is available to participants at no or low cost. Other third party training may involve charges to the participants. The availability of continuing educational credits and costs will vary from training to training. Please ask sponsoring organizations for details on related cost and continuing education credit.

Education & Training will be provided to maximize the benefits you receive from the program features:

• In-Office Training, Reference & Practice Tools
• On-Line Training, On Your Schedule
• Access to Live Trainings and Meetings
• Conference Calls, Newsletters & Email Alerts



The Satisfaction of Caring for Patents Looking for Quality Treatment with Facilitated Access to a Confidential Matching System:

• Patients who “fit” your practice
• Your practice provides what they need to succeed



Counseling and Consulting Services

We make sure you have access to what you and your patients need. Fees and Billing for third party counseling services, third party clinical and/or practice consultation are matters between the patient, the practice and those with whom they contract directly. The Aletheia Buprenorphine Safety Program does not provide these direct services.

Counseling Access – provide this key element through:

• Face–to-Face Services through a confidential matching system or On-Line
• On-Line Services with eGet-Going®



CUSTOMER SERVICE   

    Aletheia Medical Safety and Health Systems | Buprenorphine Safety Program



Aletheia Customer Service is Available to Assist You and Your Patients. We are happy to handle questions:

From Your Practice

From Your Patients

Insurance, Billing, Testing, Supplies

Weekday Business Hours 9AM- 5PM Eastern Time

Call 1-866-476-7776

Email: customerservice@aletheiamedical.com



References  



  1. Schulte, Fred and Donovan, Doug. The Bupe Fix, A 3 Part Series. The Baltimore Sun Baltimore. December 16-17, 2007
  2. Martin, Judith, MD. PCSS-B Guidance on Adherence, Diversion and Misuse of Sublingual Buprenorphine Physician Clinical Support System-Buprenorphine (PCCS-B). American Society for Addiction Medicine (ASAM) Updated 6/27/08, accessed 10/01/09.
  3. JBS International, Inc. Assessment of Emerging Indicators of Abuse and Diversion of Buprenorphine. Center for Substance Abuse Treatment’s (CSAT) 2006 accessed 10/01/09 http://buprenorphine.samhsa.gov/Buprenorphine_FinalReport_12.6.06.pdf
  4. JBS International, Inc., Final Report on the Abuse and Diversion of Buprenorphine Center for Substance Abuse Treatment (CSAT) USDHHS SAMHSA. 2006 http://buprenorphine.samhsa.gov/Buprenorphine_FinalReport_12.6.06.pdf
  5. Roosevelt Margot. Why Is The DEA Hounding This Doctor? Time Magazine-Canada July 25, 2005. Accessed 10-12-09 http://www.mapinc.org/newscsdp/v05/n1171/a04.html
  6. Drugs and Chemicals of Concern - US DOJ DEA. Accessed 10/01/09 http://www.deadiversion.usdoj.gov:80/drugs_concern/buprenorphine.htm
  7. McNicholas et al. CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40. USDHHS SAMHSA CSAT. 2004. P. xviii
  8. McCance Katz, Elinore F. M.D., Ph.D. “Emerging Clinical Challenges in Prescribing Buprenorphine,” citation of a Surveillance Report on Emerging Issues from CRS Associates - December 2007. Accessed 10/01/09 http://buprenorphine.samhsa.gov/presentations/McCance-Katz.pdf
  9. McNicholas et al. CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40. USDHHS SAMHSA CSAT. 2004. P.35
  10. McNicholas et al. CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40. . USDHHS SAMHSA CSAT. 2004. P.35
  11. JBS International. Diversion and Abuse of Buprenorphine: A Brief Assessment of Emerging Indicators - Final Report. Submitted to the SAMHSA Center for Substance Abuse Treatment Division of Pharmacologic Therapies November 30, 2006
  12. McNicholas et al. CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40. USDHHS SAMHSA CSAT. 2004. P.35
  13. McNicholas et al. CLINICAL GUIDELINES FOR THE USE OF BUPRENORPHINE IN THE TREATMENT OF OPIOID ADDICTION TREATMENT IMPROVEMENT PROTOCOL (TIP) 40. USDHHS SAMHSA CSAT. 2004. P.35
  14. JBS International, Inc., Diversion and Abuse of Buprenorphine: A Brief Assessment of Emerging Indicators, Final Report Submitted to the Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment Division of Pharmacologic Therapies November 30, 2006 Accessed 10/01/09
  15. Suboxone® is registered trademark of Reckitt Benckiser Pharmaceuticals