BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       AB 2268                                      
          A
          AUTHOR:        Chesbro                                      
          B
          AMENDED:       April 20, 2010                              
          HEARING DATE:  June 9, 2010                                 
          2
          CONSULTANT:                                                 
          2
          Dunstan/                                                    
          6
                                                                       
                8                                                  
                                        
                                     SUBJECT
                                         
                             Alcohol and drug abuse

                                     SUMMARY  

          Authorizes physicians and surgeons in California who are  
          registered with the U.S. Attorney General, pursuant to  
          specified federal law, to provide addiction treatments that  
          are allowed under federal law.

                             CHANGES TO EXISTING LAW  

          Existing law:
          Establishes the Department of Alcohol and Drug Program  
          (DADP) to license treatment facilities that provide a broad  
          range of services in a supportive environment to adults who  
          are addicted to alcohol or drugs.  

          Requires DADP to license and inspect narcotic treatment  
          programs (NTPs), which use replacement narcotic therapy in  
          the treatment of addicted persons whose addiction was  
          acquired or supported by the use of a narcotic drug or  
          drugs not in compliance with a physician and surgeon's  
          legal prescription.

          Authorizes the following controlled substances for use in  
                                                         Continued---



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          replacement narcotic therapy by licensed NTPs:  methadone,  
          levo-alphacetylmethadol (LAAM), buprenorphine products or  
          combination products approved by the federal Food and Drug  
          Administration (FDA) for maintenance or detoxification of  
          opioid dependence and any other federally approved  
          controlled substances used for the purpose of replacement  
          narcotic therapy.


          Requires DADP to establish a program for the operation and  
          regulation of office-based opiate treatment (OBOT) programs  
          that are required to hold a primary NTP license or be  
          affiliated and associated with a primary licensed NTP.   
          Defines an OBOT program as a program in which interested  
          and knowledgeable physicians provide addiction treatment  
          services, and in which community pharmacies supply  
          necessary medication both to these physicians for  
          distribution to patients and through direct administration  
          and dispensing services. 

          Allows physicians in the office-based narcotic treatment  
          program to dispense or administer pharmacologic treatment  
          for narcotic addiction that has been approved by the  
          federal Food and Drug Administration such as LAAM or  
          methadone.

          This bill:
          Authorizes physicians and surgeons in California who are  
          registered with the U.S. Attorney General, pursuant to  
          specified federal law, to provide addiction treatments that  
          are allowed under federal law.
          

                                  FISCAL IMPACT  

          This bill is keyed nonfiscal.

                            BACKGROUND AND DISCUSSION  

          According to the author, AB 2268 will align California law  
          with the federal Drug Addiction and Treatment Act (DATA) of  
          2000, which authorizes federally certified physicians to  
          conduct office-based opioid treatment using certain  
          medications authorized by the FDA.  The author notes that  
          the effect of this change will be to allow physicians to  




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          prescribe buprenorphine, a medication for the treatment of  
          opioid addiction, from their office.  The author notes that  
          existing California law does not conform to the federal  
          DATA 2000, creating a legal risk to over 1,200 physicians  
          in California who are certified by the Center for Substance  
          Abuse Treatment (CSAT) under the Substance Abuse and Mental  
          Health Administration (SAMHSA) to conduct OBOT.  

          According to the sponsor, DADP, this bill is intended to  
          ensure California's physicians maintain their key role in  
          the treatment of addiction.  DADP notes that this bill  
          clarifies that existing law allowing NTPs and OBOT programs  
          to prescribe buprenorphine does not restrict the ability of  
          other physicians who are qualified to treat opioid  
          addiction, pursuant to federal law, and who are not  
          associated with these programs, to provide this treatment  
          option to their patients.  

           Background
          According to DADP, NTPs are licensed to provide replacement  
          narcotic therapy, the most widely known and well-researched  
          treatment for individuals who are addicted to such opioids  
          as morphine, oxycodone, and codeine.  Replacement therapy  
          is a comprehensive treatment with synthetic opiates  
          approved by the FDA for opiate-addicted patients.   
          Authorized narcotic replacement medications are methadone  
          and LAAM, which are available to patients receiving  
          treatment in a licensed NTP

          According to DADP, the majority of California's NTPs are  
          privately operated.  The remaining NTPs are operated by  
          local government agencies.  Treatment aspects of each  
          program are under the supervision of a medical director who  
          is a licensed physician and surgeon.  Overall program  
          operation is the responsibility of a designated program  
          director.  DADP is responsible for ensuring that patients  
          who enroll in NTPs receive therapeutic care and that the  
          health and safety of each patient is upheld. 

          OBOT programs provide medical addiction treatment services  
          in areas of California that currently lack these services  
          by allowing existing NTPs to contract with physicians to  
          provide addiction treatment in office-based settings under  
          the license and supervision of physicians in the primary  
          licensed NTP.  Physicians in the OBOT program and their  




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          patients are required to adhere to all current state and  
          federal regulations regarding urine testing, counseling,  
          restrictions on take-home medications, and medical use of  
          methadone and LAAM in the treatment of opiate addiction.   
          Physicians in OBOT programs are authorized under current  
          law to prescribe all FDA approved medication for the  
          treatment of opiate addiction, including buprenorphine.  

          Buprenorphine is used to treat addiction to opioids by  
          preventing withdrawal symptoms so that a person can stop  
          taking the opioid drug to which he or she is addicted.  In  
          October 2002, the FDA approved two buprenorphine products,  
          Subutex and Suboxone, for use in opioid addiction  
          treatment.  Subutex and Suboxone were the first narcotic  
          drugs available for the treatment of opiate dependence that  
          can be prescribed in an office setting under the federal  
          DATA of 2000.  Prior to DATA, opiate dependence treatments  
          like methadone could be dispensed in a limited number of  
          clinics that specialize in addiction treatment.  Under  
          DATA, medications for the treatment of opiate dependence  
          are subject to less restrictive controls.  Buprenorphine  
          can be prescribed in an office-based setting by specially  
          qualified physicians, and patients can obtain a 30-day  
          supply from a pharmacy. 
           
           Pursuant to the federal DATA, qualified physicians are  
          required to obtain a waiver from the federal Center for  
          Substance Abuse Treatment to prescribe buprenorphine.   
          Physicians seeking a waiver must have a current state  
          medical license and valid Drug Enforcement Agency number;  
          be certified in specialty or subspecialty addiction from  
          the American Board of Medical Specialties, American Society  
          of Addiction Medicine, or American Osteopathic Association;  
          and, complete appropriate training.  Once a physician  
          obtains the waiver, he or she may treat up to 30 patients  
          for narcotic addiction with buprenorphine.  Physicians may  
          increase their patient limit to 100 if they have had their  
          waiver for a year or more and request the higher limit in  
          writing.  
           
           Related bills
          AB 417 (Beall) requires buprenorphine services to be  
          included within the scope of Drug Medi-Cal services,  
          subject to certain requirements.  AB 417 is in Senate  
          Appropriations Committee.




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          Prior legislation
          AB 1055 (Chesbro) of 2009, similar to this bill, would have  
          clarified that current law regarding NTP-affiliated  
          office-based addiction services is not intended to restrict  
          the scope of practice of a physician who complies with the  
          federal DATA 2000 to practice office-based opioid treatment  
          but who is not affiliated or associated with an NTP.  AB  
          1055 was held on the Assembly Appropriations Committee  
          Suspense File.  

          SB 1838 (Chesbro), Chapter 862, Statutes of 2004, among  
          other provisions, authorizes for use in replacement  
          narcotic therapy by licensed NTPs the following controlled  
          substances:  methadone, LAAM, buprenorphine products or  
          combination products approved by the FDA for maintenance or  
          detoxification of opioid dependence, and any other  
          federally approved controlled substances used for the  
          purpose of narcotic replacement treatment.

          Arguments in support
          DADP writes that this bill will eliminate the legal risk to  
          over 1,200 qualified physicians in California who are  
          already prescribing buprenorphine in their offices, and may  
          not know that state law does not conform to the federal  
          DATA of 2002.  DADP states that this bill will clarify that  
          qualified physicians in California are authorized to treat  
          opioid dependence in their private practices as they would  
          any other illness, subject to the requirements of DATA, and  
          will substantially increase access to treatment for  
          underserved populations in rural areas that do not have  
          NTPs and have residents must use public transit and travel  
          hours to the nearest NTP.  


                                  PRIOR ACTIONS

           Assembly Health Committee                8-0
          Assembly Floor         71-0


                                         

                                   POSITIONS  
                                        




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          Support:  Department of Alcohol and Drug Programs (ADP)  
          (sponsor)

          Oppose:  None received




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