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--- STAFF ANALYSIS OF ASSEMBLY BILL 2268 (Chesbro) Page 2 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 STAFF ANALYSIS OF ASSEMBLY BILL 2268 (Chesbro) Page 3 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 STAFF ANALYSIS OF ASSEMBLY BILL 2268 (Chesbro) Page 4 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. STAFF ANALYSIS OF ASSEMBLY BILL 2268 (Chesbro) Page 5 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 STAFF ANALYSIS OF ASSEMBLY BILL 2268 (Chesbro) Page 6 Support: Department of Alcohol and Drug Programs (ADP) (sponsor) Oppose: None received -- END --