BILL ANALYSIS                                                                                                                                                                                                    



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          Date of Hearing:   May 3, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          AB 1977  
          (Wood) - As Amended April 13, 2016


          SUBJECT:  Opioid Abuse Task Force.


          SUMMARY:  Establishes the Opioid Abuse Task Force (Task Force)  
          to develop recommendations to the Legislature regarding the  
          abuse and misuse of opioids in California.  Specifically, this  
          bill:  


          1)Requires health care service plans (health plan) and health  
            insurer representatives, in collaboration with advocates,  
            experts, health care professionals, and other entities and  
            stakeholders that they deem appropriate, to convene a Task  
            Force, on or before February 1, 2017, that will develop  
            recommendations regarding the abuse and misuse of opioids, as  
            specified. 


          2)Requires the Task Force to address all of the following:


             a)   Interventions that have been scientifically validated  
               and have demonstrated clinical efficacy; 


             b)   Interventions that have measurable treatment outcomes;








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             c)   Collaborative, evidence-based approaches to resolving  
               opioid abuse and misuse that incorporate both the provider  
               and the patient into the solution; 


             d)   Education that engages and encourages providers to be  
               prudent in prescribing opioids and to be proactive in  
               defining care plans that include a plan to taper and stop  
               opioid use; and,


             e)   Review and consider medication coverage policies and  
               formulary management and development of an  
               interdisciplinary case management program that addresses  
               quality, fraud, waste, and abuse.


          3)Requires the Task Force to submit a report detailing its  
            findings and recommendations to the Governor, President pro  
            Tempore of the Senate, Speaker of the Assembly, and the Senate  
            and Assembly Committees on Health, on or before December 31,  
            2017.


          4)Terminates the Task Force on June 1, 2018.


          5)Repeals the provisions of this bill on January 1, 2019, unless  
            a later enacted statute deletes or extends that date.


          EXISTING LAW:  


          1)Establishes the Knox-Keene Health Care Service Plan Act of  
            1975, which provides for the licensure and regulation of  
            health plans by the Department of Managed Health Care (DMHC),  








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            and provides for the regulation of health insurers under the  
            Insurance Code by the California Department of Insurance  
            (CDI).

          2)Mandates 10 federally required essential health benefits  
            (EHBs) in the individual and small group market and  
            establishes the Kaiser Small Group health plan as California's  
            EHB benchmark plan, including prescription drug benefits, as  
            specified, and incorporates by reference state law and  
            regulations related to outpatient prescription drug coverage.

          3)Classifies controlled substances into five designated  
            schedules, with the most restrictive limitations generally  
            placed on controlled substances classified in Schedule I, and  
            the least restrictive limitations generally placed on  
            controlled substances classified in Schedule V.

          4)Provides for the licensure and regulation of pharmacists by  
            the California Board of Pharmacy.

          5)Prohibits the delivery of Schedule II, III, or IV controlled  
            substances to a pharmacy unless a receipt for the merchandise  
            is signed by a pharmacist or authorized receiving personnel. 


          FISCAL EFFECT:  None.  


          COMMENTS:  


          1)PURPOSE OF THIS BILL.  According to the author, not enough is  
            being done to curb the growth of opioid abuse, and health care  
            providers and parents need tools to help guard against the  
            abuse of opioid medication.  The author cites education for  
            patients on the proper storage and disposal of opioids, as  
            well as the development and availability of abuse-deterrent  
            opioids, which are formulated to prevent manipulation of the  
            drug for the purpose of misuse, as strategies that should be  








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            encouraged to combat opioid abuse.  The Task Force will engage  
            various stakeholders to discuss such strategies to  
            specifically address the problems related to the abuse and  
            misuse of opioids.  The Task Force will then submit a report  
            detailing its findings and recommendations to the Legislature  
            for consideration of a hopefully more comprehensive approach  
            to deal with this issue.  


          2)BACKGROUND.  


             a)   Opioids and opioid abuse.  Certain drugs are classified  
               under the federal Controlled Substances Act of 1970 (CSA)  
               into one of five schedules.  Placement in a given schedule  
               depends on whether a drug has a currently accepted medical  
               use, its relative abuse potential, and its likelihood of  
               causing either addiction or physical dependency when  
               abused.  The Attorney General, acting through the Drug  
               Enforcement Administration, is responsible for scheduling  
               controlled substances.  Most opioid analgesics are schedule  
               II drugs, in that they have a recognized medical use, but  
               also have a high potential for abuse which may lead to  
               severe psychological dependence or severe physical  
               dependence.  The CSA places a number of restrictions on  
               prescribers and pharmacies that dispense controlled  
               substances like opioids.  Additionally, refills are not  
               permitted and a new written prescription must be presented  
               each time the drug is dispensed.  


               Opioids are a class of narcotic drugs that include  
               medications such as hydrocodone, oxycodone, morphine,  
               codeine, and other related drugs.  Taken as prescribed,  
               opioids can be used to manage pain safely and effectively.   
               However, opioids may also produce other effects, and  
               according to the National Institute on Drug Abuse (NIDA),  
               some individuals experience a euphoric response to opioid  
               medications since these drugs affect the regions of the  








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               brain involving reward response.  


               NIDA states that those who abuse opioids may seek to  
               intensify their experience by taking the drug in ways other  
               than those prescribed.  For example, OxyContin is an oral  
               medication used to treat moderate to severe pain through a  
               slow, steady release of the opioid.  However, NIDA states  
               that people who abuse the drug may crush or dissolve the  
               drug in order to snort or inject it, thereby increasing  
               their risk for serious medical complications, including  
               overdose.  NIDA states that when abused, even a single  
               large dose of opioids can cause severe respiratory  
               depression and death.

               According to the California Department of Public Health  
               (DPH), in the past, prescription opioids were prescribed  
               for relieving short-term, acute pain.  However, today, they  
               are increasingly being used for long-term (chronic) pain  
               management.  As a result, sales of opioid pain relievers  
               quadrupled in the past 10 years.  By 2010, enough opioid  
               pain relievers were sold to medicate every American adult  
               (about 240 million people) every four hours for an entire  
               month.  DPH states that in California, deaths involving  
               opioid prescription medications have increased 16.5% since  
               2006.  In 2012, there were more than 1,800 deaths from all  
               types of opioids - 72% involved prescription opioids.
             b)   Prescription Opioid Misuse and Overdose Prevention  
               Workgroup.  In response to the national epidemic of  
               prescription medication misuse and overdose, DPH and its  
               state partners, including the Board of Pharmacy and the  
               Medical Board of California, convened a Prescription Opioid  
               Misuse and Overdose Prevention Workgroup in Spring 2014.   
               This workgroup is exploring opportunities to improve  
               collaboration and expand joint efforts among state  
               departments working to address this epidemic.  It has  
               identified two priorities:  expansion and strengthening of  
               prevention strategies and improvement of monitoring and  
               surveillance. 








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             c)   Opioid Safety Coalitions Network.  The California  
               HealthCare Foundation (CHCF) is currently providing  
               technical assistance to 16 Opioid Safety Coalitions in 24  
               counties across California.  Opioid Safety Coalitions  
               throughout the state bring together a broad group of  
               stakeholders committed to decreasing opioid overuse and  
               overdose deaths.  CHCF requested that the Opioid Safety  
               Coalitions identify and implement collective actions to  
               reduce the opioid overuse epidemic through at least one  
               intervention in each of the following federal priority  
               areas:  supporting safe prescribing practices; expanding  
               access to medication-assisted addiction treatment; and,  
               increasing naloxone access.  


             d)   Federal Responses.  Recently, President Obama introduced  
               a number of policy changes and new grant opportunities to  
               address the growing opioid abuse epidemic.  Among the new  
               steps announced, the Obama Administration is launching a  
               new task force on mental health parity aimed at ensuring  
               that 23 million people in Medicaid receive the same access  
               to mental health and drug addiction benefits as people with  
               private health plans. Additionally, President Obama  
               announced $120 million worth of grants, $94 million of  
               which had already been promised to community health centers  
               under the Patient Protection and Affordable Care Act.  Most  
               substantially, President Obama unveiled that the  
               Administration is aiming to expand access to  
               medication-assisted treatment by releasing a proposed rule  
               that changes restrictions on the amount of patients per  
               practitioner that may be prescribed medications that treat  
               opioid dependence.  Specifically, the proposal would raise  
               the existing limit of 100 patients per practitioner to 200  
               patients for a subset of practitioners, provided they  
               fulfill several additional requirements. 










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               The House Committee on Oversight and Government Reform  
               recently convened a hearing to discuss ways to improve the  
               federal response to the heroin and opioid abuse problem as  
               the House considers a path forward on bipartisan  
               legislation.  This hearing follows Senate passage of a bill  
               earlier this year, the Comprehensive Addiction and Recovery  
               Act (S. 524) (CARA), which would authorize the  
               Administration to offer grants to states to expand their  
               treatment offerings and increase access to naloxone, an  
               overdose prevention drug.  CARA would also give the U.S.  
               Department of Justice additional tools to combat drug  
               trafficking.


               Additionally, the Centers for Disease Control and  
               Prevention (CDC) issued new prescribing guidelines for  
               opioids, which may help doctors and patients better  
               understand the risks associated with prescription  
               painkiller use.  In addition to the CDC guidelines, the  
               Obama Administration requested more than $1 billion in new  
               mandatory funding in next year's budget to address opioid  
               drug abuse.  The Food and Drug Administration (FDA)  
               announced changes to the safety warnings that are required  
               on the labels of prescription painkillers - the labels must  
               now include a boxed warning about risks of misuse,  
               addiction, overdose, and death.  FDA also revealed new  
               steps to scrutinize applications for prescribing opioids.


             e)   Legislation in other states.  According to the National  
               Conference of State Legislatures, there are approximately  
               32 bills introduced in 2016 having to do with opioid drug  
               abuse.  In 2015, Tennessee enacted legislation that  
               requires the commissioner of mental health and substance  
               abuse services to convene a working group to examine the  
               problem of opioid abuse in the state and the potential  
               impact of the use of FDA-approved abuse-deterrent opioids  
               and the issue of prescription drugs.









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               Massachusetts became the first state to establish a  
               seven-day limit on first-time opioid prescriptions.  The  
               new law, An Act Relative to Substance Use, Treatment,  
               Education and Prevention, was passed unanimously by the  
               Massachusetts state legislature, and requires a seven-day  
               supply limit on initial opioid prescriptions for adults and  
               all opioid prescriptions for minors.


          3)SUPPORT.  The County Behavioral Health Directors Association  
            of California states that this bill is consistent with federal  
            initiatives, like the Mental Health and Substance Use Disorder  
            Parity Task Force, and takes an important step toward  
            addressing opioid abuse by establishing a statewide Task  
            Force.  The County Health Executives Association of California  
            (CHEAC), the California State Sheriffs' Association (CSSA),  
            and the California Primary Care Association supported a  
            previous version of this bill.  CHEAC notes that with the  
            inclusion of abuse-deterrent opioids, physicians in California  
            would have the option to prescribe drugs that would  
            effectively manage patient pain while also minimizing the risk  
            of abuse and diversion.  CHEAC also states that local health  
            departments support efforts to reduce and prevent drug  
            addiction and related problems.  The California State  
            Sheriffs' Association (CSSA) notes that the abuse of  
            prescription drugs continue to increase and particularly  
            alarming is the frequency with which minors use medicine meant  
            for therapeutic purposes and/or for other persons for  
            non-medical reasons.  


          4)NEUTRAL.  The America's Health Insurance Plans was previously  
            opposed to this bill and is now neutral and appreciates the  
            author's leadership role in addressing the issue of opioid  
            abuse and looks forward to continuing a constructive dialogue  
            regarding how best to address this growing epidemic.  










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          5)OPPOSE UNLESS AMENDED.  The California Medical Association  
            (CMA) opposed a previous version of this bill and states that  
            effective solutions require a sustained, cooperative effort on  
            the part of all stakeholders, including physicians, patients,  
            law enforcement, regulatory agencies, insurers, and the  
            pharmaceutical industry.  


          6)OPPOSITION.  California Association of Health Plans (CAHP),  
            the Association of California Life and Health Insurance  
            Companies, and America's Health Insurance Plans were opposed  
            to a previous version of this bill and contend that health  
            insurance mandates threaten the efforts of all health care  
            stakeholders to provide consumers with meaningful health care  
            choices and affordable coverage options.  CAHP also states  
            that more work also needs to be done in finding a pathway to  
            lower-cost options in the opioid market.  Kaiser Permanente  
            (Kaiser) was also opposed to a previous version of this bill  
            and states that abuse-deterrent drugs are fairly new, quite  
            costly, and there is insufficient evidence about their  
            efficacy in deterrence and prevention of abuse.  Blue Shield  
            of California (Blue Shield) was also opposed to a previous  
            version of this bill and states that coverage of  
            abuse-deterrent formulations on a health plan's formulary at  
            the lowest copayment or coinsurance does little to address the  
            underlying causes of opioid overuse and abuse.  It should be  
            noted that all the provisions that were opposed have been  
            deleted from this bill.  

          7)RELATED LEGISLATION.  AB 2592 (Cooper) creates within DPH a  
            pilot program that would award grants to eligible pharmacies  
            for the purpose of supplying medicine locking closure packages  
            to patients with prescriptions for opioids.  AB 2592 is  
            currently pending in the Assembly Appropriations Committee.


          8)PREVIOUS LEGISLATION.  

             a)   AB 623 (Wood) from 2015 would have prohibited a health  








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               plan or health insurer from requiring the use of opioid  
               drug products that have no abuse-deterrent properties in  
               order to access abuse-deterrent opioid drug products;  
               required pharmacists to provide a patient receiving an  
               opioid drug product information about proper storage and  
               disposal of the drug; and, authorized a provider to  
               prescribe a less than 30-day supply of opioids analgesic  
               drugs.  AB 623 was held in the Assembly Appropriations  
               Committee.

             b)   AB 831 (Bloom) from 2013 would have required, until  
               January 1, 2016, the California Health and Human Services  
               Agency (CHHSA) to convene a temporary working group to  
               develop a state plan to reduce the rate of fatal drug  
               overdoses and appropriates $500,000 from the General Fund  
               to CHHSA to provide grants to local agencies to implement  
               drug overdose prevention and response programs.  This bill  
               was held in the Assembly Appropriations Committee. 


             c)   AB 369 (Huffman) of 2012 would have prohibited health  
               plans and health insurers that restrict medications for the  
               treatment of pain from requiring a patient to try and fail  
               on more than two pain medications before allowing the  
               patient access to the pain medication, or its generic  
               equivalent, prescribed by his or her physician.  This bill  
               was vetoed with the Governor's veto message stating that a  
               doctor's judgment and a health plan's clinical protocols  
               have a role in ensuring prudent prescribing of pain  
               medications, and any limitations on the practice of step  
               therapy should better reflect a health plan or insurer's  
               legitimate role in determining the allowable steps.  


             d)   AB 1826 (Huffman) of 2010 would have required a health  
               plan or health insurer that covers prescription drug  
               benefits to provide coverage for a drug that has been  
               prescribed for the treatment of pain without first  
               requiring the enrollee or insured to use an alternative  








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               drug or product.  This bill was held in the Senate  
               Appropriations Committee.


             e)   AB 1144 (Price) of 2009 would have required health plans  
               and health insurers to report to DMHC and CDI specified  
               information related to chronic pain medication management,  
               including when the health plan or health insurer requires  
               an enrollee or insured to use of more than two formulary  
               alternative medications prior to providing access to a pain  
               medication prescribed by a provider, or to use pain  
               medication other than what was prescribed for more than  
               seven days prior to providing access to the prescribed pain  
               medication.  This bill was held in the Assembly  
               Appropriations Committee.


          REGISTERED SUPPORT / OPPOSITION:




          Support


          California District Attorneys Association


          California Health Executives Association of California (previous  
          version)


          California Narcotic Officers' Association (previous version)


          California Primary Care Association (previous version)


          California State Sheriffs' Association (previous version)








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          County Behavioral Health Directors Association of California


          L.A. Care


          Pharmaceutical Care Management Association


          Public Policy Advocates




          Opposition


          America's Health Insurance Plans (previous version)


          Association of California Life and Health Insurance Companies  
          (previous version)


          Blue Shield of California 


          California Association of Health Plans (previous version)


          California Association of Joint Powers Authorities (previous  
          version)


          California Chamber of Commerce (previous version)










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          California Retailers Association (previous version)


          California Medical Association (previous version)


          CVS Health (previous version)


          Express Scripts Holding Company (previous version)


          Kaiser Permanente 


          Pharmaceutical Care Management Association (previous version)







          Analysis Prepared by:Kristene Mapile / HEALTH / (916) 319-2097