BILL ANALYSIS                                                                                                                                                                                                    



                                                                     AB 623


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          Date of Hearing:   April 28, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


          AB 623  
          (Wood) - As Amended March 26, 2015


          NOTE:  This bill is double-referred, having been previously  
          heard by the Assembly Committee on Health on April 21, 2015 and  
          approved on a 15-4 vote.  


          SUBJECT:  Abuse-deterrent opioid analgesic drug products.


          SUMMARY:  Prohibits a health care service plan (plan) or health  
          insurer (insurer) from requiring the use of opioid drug products  
          that have no abuse-deterrent properties in order to access  
          abuse-deterrent opioid drug products;  requires pharmacists to  
          provide a patient receiving an opioid drug product information  
          about proper storage and disposal of the drug; and, mandates  
          that a plan and insurer may not prevent a provider from  
          prescribing a less than 30-day supply of opioids analgesic drugs  
          and to provide coverage, if otherwise covered, for the less than  
          30-day prescription.  


          EXISTING LAW:


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








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            Managed Health Care (DMHC), and provides for the regulation of  
            health insurers by the California Department of Insurance  
            (CDI). (Health and Safety Code (HSC) Sections 1340 et seq.)

          2)Pursuant to DMHC regulations, states that a plan may require  
            step therapy and requires a plan to have an expeditious  
            process in place to authorize exceptions to step therapy when  
            medically necessary.  (California Code of Regulation (CCR)  
            Title 28 Division 1 Section 1367.24(d)(2))



          3)Requires plans and insurers to include information on  
            cost-sharing tiers and utilization controls, including prior  
            authorization or step therapy requirements, for each covered  
            drug.  (28 CCR Section 1367.24(d)(2))

          4)Allows a plan to limit the amount of the drug dispensed at any  
            one time to a 30-day supply or, if the treatment is for less  
            than 30 days, for the medically necessary amount of the drug  
            and allows for the imposition of a requirement that  
            maintenance drugs be dispensed in a two months or greater  
            supply. (28 CCR Section 1367.24(d)(3))

          5)Prohibits health plans that cover prescription drugs from  
            limiting or excluding coverage for a drug on the basis that  
            the drug is prescribed for use different from that for which  
            the drug has been approved by the federal Food and Drug  
            Administration (FDA), provided that specified conditions have  
            been met, including that the drug is prescribed by a  
            participating licensed health care professional for the  
            treatment of a chronic and seriously debilitating condition,  
            the drug is medically necessary to treat that condition, and  
            the drug is on the plan formulary.  (HSC 1367.21)

          6)Prohibits health plans that cover prescription drugs from  
            limiting or excluding coverage for a drug for an enrollee if  
            the drug was previously approved for coverage by the plan for  
            a medical condition of the enrollee and the plan's prescribing  








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            provider continues to provide the drug for the medical  
            condition, provided that it is safe and effective for  
            treatment.  (HSC 1367.22)

          7)Provides for the licensure and regulation of pharmacists by  
            the California Board of Pharmacy (BOP).  (Business and  
            Professions Code (BPC) Section 4000 et seq.)

          8)Requires, under existing regulations, a pharmacist to provide  
            oral consultation to a patient in all care settings under the  
            following circumstances: (16 CCR 1707.2)

             a)   Upon request by the patient; or,

             b)   Whenever the pharmacist deems a consultation is  
               warranted in the exercise of his or her professional  
               judgment, and,

             c)   When the prescribed drug has not previously been  
               dispensed to a patient; or,

             d)   When the prescription drug is dispensed that has not  
               been previously dispensed to a patient in the same dosage,  
               strengths, or with the same directions.



          9)Gives the pharmacist the discretionary authority to provide  
            information during oral consultation relating to any special  
            directions for use and storage.  (16 CCR 1707.2)



          10)Allows a patient to waive the oral consultation with a  
            pharmacist under specified conditions.  (16 CCR 1707.2)  



          THIS BILL:








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          1)Requires a pharmacist to inform a patient receiving an opioid  
            analgesic drug product on proper storage and disposal of the  
            drug, and authorizes the information to be provided as part of  
            an oral consultation, as specified.


          2)Defines "opioid analgesic drug product" as a drug product in  
            the opioid analgesic drug class that is prescribed to treat  
            moderate to severe pain, or other conditions, whether in  
            immediate release or extended release or long-acting form and  
            whether or not combined with other drug substances to form a  
            single drug product or dosage form.


          3)Defines "abuse-deterrent opioid analgesic drug product" as a  
            brand or generic opioid analgesic drug product approved by the  
            FDA with abuse-deterrent labeling claims that indicate the  
            drug product is expected to result in a meaningful reduction  
            in abuse.


          4)Prohibits, where an abuse-deterrent opioid analgesic drug  
            product is available, a plan or insurer from requiring the use  
            of opioid analgesic drug products without abuse-deterrent  
            properties first before allowing access to abuse-deterrent  
            opioid analgesic drug products.


          5)Provides that this bill shall not be construed to prevent a  
            plan or insurer from applying prior authorization requirements  
            to abuse-deterrent opioid analgesic drug products, provided  
            that those same requirements are applied to versions of those  
            opioid analgesic drug products without the abuse-deterrent  
            properties.


          6)Mandates that a plan or insurer may not prevent a health care  








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            provider from prescribing a less than 30-day supply of an  
            opioid analgesic drug product and requires the plan or insurer  
            to cover a less-than 30-day supply if otherwise covered.


          7)Makes legislative findings and declarations relating to opioid  
            analgesic drug abuse.


          FISCAL EFFECT:  Unknown.  This bill is keyed fiscal by the  
          Legislative Counsel. 


          COMMENTS:


          1)Purpose.  This bill is sponsored by the  American Chronic Pain  
            Association  , the  Power of Pain Foundation  , and the  United  
            States Pain Foundation  .  According to the author, "As a health  
            care provider focused on the value of prevention, I believe  
            that not enough is being done to curb the growth of opioid  
            abuse.  Health care providers and parents need tools to help  
            guard against the abuse of medication by people who are not  
            necessarily the patient.  Curbing abuse will mean fewer  
            unintentional overdoses.  There is nowhere in the state that  
            is immune to the problem of opioid abuse, particularly among  
            young people.  In Mendocino County, the problem is so acute  
            that hospital admissions for narcotic overdoses are twice the  
            state average. . . .  Strategies like educating patients on  
            the proper storage and disposal should help protect  
            medications from being readily available and accessible for  
            those wanting to abuse.  Additionally, the development and  
            availability of new drugs, abuse deterrent formula (ADF),  
            which cannot be manipulated or crushed to intensify a high,  
            should be encouraged.  While it is estimated that these  
            methods (crushing or dissolving) account for 30% of the abuse,  
            this form of abuse is what results in the majority of ER  
            visits, hospitalizations and deaths. . . . The pressures on  
            cost in our health care system and huge and should not be  








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            ignored but there are times when it is obvious we either pay  
            now for something or pay later.   We are already paying the  
            price for abuse.  The more widespread ADF's become the more  
            positive an impact we can have on abuse.  The increased  
            availability and competition will also lead to reduced cost."


          2)Background.  Opioids are a class of narcotic drugs that  
            include medications such as hydrocodone (e.g. Vicodin),  
            oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian,  
            Avinza) codeine, and other related drugs.  Through the  
            Controlled Substances Act of 1970 (CSA), the Drug Enforcement  
            Administration (DEA) regulates the manufacture, distribution  
            and dispensing of controlled substances.  The CSA ranks into  
            five schedules those drugs known to have potential for  
            physical or psychological harm, based on three considerations:  
            1) their potential for abuse, 2) their accepted medical use,  
            and 3) their accepted safety under medical supervision.   
            Presently, the ADF formulations on the market and pending FDA  
            approval are Schedule II drugs.


             Schedule I  controlled substances have a high potential for  
            abuse and have no generally accepted medical, use such as  
            heroin, ecstasy, and LSD. 


             Schedule II controlled substances have a currently accepted  
            medical use in treatment, or a currently accepted medical use  
            with severe restrictions, and have a high potential for abuse  
            and psychological or physical dependence.  Schedule II drugs  
            can be narcotics or non-narcotic.  Examples of Schedule II  
            controlled substances include morphine, methadone, Ritalin,  
            Demerol, Dilaudid, Percocet, Adderall, and Oxycontin.  In  
            October of 2014, the DEA as a response to the rising  
            prescription drug abuse epidemic promulgated a rule  
            rescheduling hydrocodone containing prescriptions (e.g.,  
            Vicodin) into this more tightly controlled category (21 Code  
            of Federal Regulations 1308).








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             Schedule III and IV  controlled substances have a currently  
            accepted medical use in treatment, less potential for abuse  
            but are known to be mixed in specific ways to achieve a  
            narcotic-like end product.  Examples include drugs include  
            Tylenol with Codeine, Ambien, Xanax, and other anti-anxiety  
            drugs.


             Schedule V  drugs have a low potential for abuse relative to  
            substances listed in Schedule IV and consist primarily of  
            preparations containing limited quantities of certain  
            narcotics.  Examples include Robitussin with Codeine and  
            Lomotil.


            Prescription Drug Abuse.  According the Drug Abuse Warning  
            Network, a division of the Substance Abuse and Mental Health  
            Agency, prescription drug misuse and abuse is the intentional  
            or unintentional use of medication without a prescription, in  
            a way other than prescribed, or for the experience or feeling  
            it causes. Results from the 2013 National Survey on Drug Use  
            and Health indicate that about 15.3 million people aged 12 or  
            older used prescription drugs non-medically in the past year,  
            and 6.5 million did so in the past month.  This issue is a  
            growing national problem in the United States.  Prescription  
            drugs are abused and misused more often than any other drug,  
            except marijuana and alcohol.  This growth is fueled by  
            misperceptions about their safety, increasing availability,  
            and varied motivations for their use from countering anxiety  
            and helping sleep problems to getting high. A 2011 analysis by  
            the Centers for Disease Control and Prevention found that  
            opioid analgesic sales increased nearly four-fold between 1999  
            and 2010; this was paralleled by an almost four-fold increase  
            in opioid overdose deaths and substance abuse treatment  
            admissions almost six times the rate during the same time  
            period.









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            Abuse can stem from the fact that prescription drugs are legal  
            and potentially more easily accessible, as they can be found  
            at home in a medicine cabinet.  Data shows that individuals  
            who misuse prescription drugs, particularly teens, believe  
            these substances are safer than illicit drugs because they are  
            prescribed by a health care professional and thus are safe to  
            take under any circumstances.  The National Institute on Drug  
            Abuse (NIDA) data indicates that in actuality, prescription  
            drugs act directly or indirectly on the same brain systems  
            affected by illicit drugs, thus, their abuse carries  
            substantial addiction liability and can lead to a variety of  
            other adverse health effects. 

            A 2008 report by the Coalition Against Insurance Fraud  
            estimates that the abuse of opioid analgesics results in more  
            than $72 billion in medical costs alone each year. This is  
            comparable to costs related to other chronic diseases such as  
            asthma and HIV.

            The Senate Committee on Labor held a hearing on March 20th,  
            2013 entitled Opioids and the Workers Compensation System: A  
            Discussion on Mitigating Abuse and Ensuring Access during  
            which the Committee reviewed a series of studies conducted by  
            the California Workers' Compensation Institute which  
            highlighted a rise in opioid analgesic prescriptions by  
            physicians in the state workers' compensation system.  The  
            studies identified trends in widespread, potent use of  
            Schedule II drugs by patients with low back pain; significant  
            growth in the prescribing of all Schedule II drugs in the  
            workers' compensation system; and found that 6.7 percent of  
            all prescriptions in the system for the first half of 2011  
            alone were for opioids.


          Taken as prescribed, opioids analgesic can be used to manage  
            pain safely and effectively.  However, opioids may also  
            produce other effects, and according to the NIDA, some  
            individuals experience a euphoric response to opioid  
            medications since these drugs affect the regions of the brain  








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            involving reward response.  



          The 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, the 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.  The  
            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 (CDPH),  
            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.  The  
            CDPH states that in California, deaths involving opioid  
            prescription medications have increased 16.5 percent since  
            2006. In 2012, there were more than 1,800 deaths from all  
            types of opioids - 72 percent involved prescription opioids.
            Abuse-deterrent opioids. According to the FDA, opioid products  
            can be abused in a number of ways, including being swallowed  
            whole; crushed in order to be swallowed, snorted, smoked; and,  
            dissolved and injected.  Opioids formulated with  
            abuse-deterrent properties are designed to be more difficult  
            to abuse, while retaining the same clinical effectiveness.   
            For example, abuse-deterrent opioids may be formulated in ways  
            that prevent chewing, crushing, grating, or grinding.  Others  
            may be formulated with agents that can make the drug resistant  
            to dissolving by turning the drug into a gel-like substance  
            when manipulated.  Other formulations can reduce or defeat  
            euphoria associated with the drug, or result in an unpleasant  








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            effect if the drug is manipulated.



            The FDA released industry guidance on April 1, 2015 regarding  
            the evaluation and labeling of abuse-deterrent opioids, citing  
            the development of abuse-deterrent opioids as a potentially  
            important step toward the goal of creating safer opioid  
            analgesics, and considers the development of abuse-deterrent  
            opioids a high public health priority.  The FDA also noted  
            that abuse-deterrent technologies developed to date have not  
            yet proven successful at deterring the most common form of  
            abuse - swallowing a number of intact capsules or tables to  
            achieve a feeling of euphoria.  Further, the FDA stated that  
            the science of abuse deterrence is relatively new, and both  
            the formulation technologies and the analytical, clinical, and  
            statistical methods for evaluating the technologies are  
            rapidly evolving.

            Four opioids have been approved for abuse-deterrent labeling  
            and there are a number of generic and brand opioid products  
            with different types of abuse-deterrent technologies that seek  
            labeling.  One of the four currently approved is OxyContin,  
            which, in 2010, was reformulated as an abuse-deterrent opioid.  
             It was approved for ADF labeling in April 2013, indicating  
            that the product has physical and chemical properties that are  
            expected to make abuse via injection difficult and to reduce  
            abuse via snorting.  OxyContin's manufacturer replaced the  
            original OxyContin formulation in 2010 with its  
            abuse-deterrent formulation, and upon approval of the labeling  
            in 2013, the FDA stopped accepting applications for generics  
            that rely upon the approval of original formulation of  
            OxyContin.  
            Potential Public Health Impact.  In terms of the public health  
            impact of abuse-deterrent opioids, the author cites research  
            published in April 2014 in the Journal of Medical Economics  
            which estimated that abuse-deterrent formulation of OxyContin  
            reduced overall health care costs by $430 million annually in  
            the U.S., with an indirect cost savings of $605 million.   








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            Using health insurance claims data, government reports and  
            literature, the study estimated that these savings represented  
            1.8percent of $58.4 billion in overall societal costs of  
            prescription opioid abuse.  





            The author also cites a May 2105 study in Econostats that  
            compared the financial impact between generic opioids without  
            abuse-deterrent properties.  The article cites, "That the  
            average cost and most expensive cost for a one-month supply  
            for patented opioids on the market as of July 2012 was $373  
            and $692, respectively.  The average cost and least expensive  
            cost for a one-month supply of generic opioids on the market  
            as of July 2012 was $233 and $48, respectively.  The price gap  
            between the average patented cost and the average generic cost  
            was $140."  When looking at the overall costs of opioid abuse,  
            "The current evidence shows that abuse-deterrent opioids will  
            reduce the costs of opioid abuse per opioid patient by $4,568  
            to $4,645, depending upon the patient's insurance status.   
            Accounting for the estimated additional cost of  
            abuse-deterrent opioids (between $612 and $2,811), these  
            medicines are associated with a net economic benefit between  
            $1,757 and $4,033."





            In a July 2012 article, the New England Journal of Medicine  
            determined, "Interviews with patients who abused both  
            formulations of OxyContin indicated a unanimous preference for  
            the older version. Although 24 percent found a way to defeat  
            the tamper-resistant properties of the abuse-deterrent  
            formulation, 66 percent indicated a switch to another opioid,  
            with "heroin" the most common response. These changes appear  
            to be causally linked, as typified by one response: 'Most  








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            people that I know don't use OxyContin to get high anymore.  
            They have moved on to heroin [because] it is easier to use,  
            much cheaper, and easily available." It is important to note  
            that there was no evidence that OxyContin abusers ceased their  
            drug abuse as a result of the abuse-deterrent formulation.  
            Rather, it appears that they simply shifted their drug of  
            choice.'"
            Step Therapy.  According to the Centers for Medicare and  
            Medicaid Services (CMS), step therapy is defined as:  A health  
            service plan or insurer may require you to first try one drug  
            before they will cover another drug for that condition. For  
            example, if Drug A and Drug B both treat your medical  
            condition, a plan may require your doctor to prescribe Drug A  
            first. If Drug A does not work for you, then the plan will  
            cover Drug B.  For example, before your insurance company will  
            pay for a prescription of Hysingla (a brand name  
            extended-release ADF formulation of hydrocodone (commonly  
            known as Vicodin or Norco)), an insurer can currently require  
            that your have tried regular hydrocodone formulation like  
            Vicodin or Norco which have none of the ADF properties. 





            Other States.  This year, at least fifteen other bills  
            relating to abuse-deterrent opioids have been introduced in  
                                                   other states, including Colorado, Connecticut, Florida,  
            Kansas, Maryland, Mississippi, Oklahoma, Rhode Island,  
            Tennessee, Vermont, and Virginia.  In 2014, legislation on  
            this topic was introduced in New Jersey.  The requirements of  
            the bills vary across states, with some bills containing  
            similar requirements as those proposed in this bill, but  
            overall, the bills aim to expand coverage and access to  
            abuse-deterrent opioids.  Additionally, there is an abundance  
            of legislation nationwide relating to various aspects of the  
            prescription drug abuse epidemic including increasing access  
            to naloxone (opioid overdose antidote), medication take-back  
            programs, tighter regulations for identification requirements  








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            prior to dispensing opioids, and improving prescription  
            monitoring programs.  





          Current Related Legislation.  ACR 26 (Levine), Chapter 16,  
            Statutes of 2015, proclaimed the month of March 2015 as  
            Prescription Drug Abuse Awareness Month and encourages all  
            citizens to actively participate in prevention programs and  
            activities, and to safely store and dispose of their  
            medications on a continual basis.


          AB 73 (Waldron) of the current legislative session, provides  
            that drugs in specified therapeutic drug classes that are  
            prescribed by a Medi-Cal beneficiary's treating provider are  
            covered Medi-Cal benefits and requires that a Medi-Cal managed  
            care plan cover the drug upon demonstration by the provider  
            that the drug is medically necessary and consistent with  
            federal rules and regulations for labeling and use.  (STATUS:  
            This bill is pending in the Assembly Health Committee.)


          Previous Related Legislation.  AB 1535 (Bloom), Chapter 326,  
            Statutes of 2014, authorizes a pharmacist to furnish naloxone  
            hydrochloride (opioid overdose antidote) in accordance with  
            standardized procedures or protocols developed and approved by  
            both the BOP and the Medical Board of California.  


          AB 1814 (Waldron) of 2014, would have established that a  
            prescriber's reasonable professional judgment prevails over  
            the policies and utilization controls of the Medi-Cal program,  
            including the utilization controls of a Medi-Cal managed care  
            plan, in prescribing a pharmaceutical from specified  
            therapeutic drug classes.  (NOTE: This bill was held in the  
            Assembly Appropriations Committee.)








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          AB 831 (Bloom) of 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.  (NOTE: This bill was held in the Assembly  
            Appropriations Committee.)


          AB 889 (Frazier) of 2013, would have prohibited a plan and  
            insurer that provides coverage for medications pursuant to  
            step therapy or fail first protocol from requiring an enrollee  
            or insured to try and fail more than two medications before  
            allowing the enrollee or insured access to the medication  
            originally prescribed by their provider, and would have  
            required plans and insurers to have an expeditious process in  
            place for step therapy exceptions and that the duration of  
            step therapy be consistent with up-to-date evidence-based  
            outcomes and current published peer-reviewed medical and  
            pharmaceutical literature.  (NOTE: This bill was held in the  
            Senate Appropriations Committee.)


          AB 369 (Huffman) of 2012, would have prohibited plans and  
            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.  (NOTE: This bill was vetoed by Governor Brown  
            with a 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.)  









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          AB 1826 (Huffman) of 2010, would have required a plan or 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 drug or product.  (NOTE: This bill was held in the  
            Senate Appropriations Committee.)


          AB 1144 (Price) of 2009, would have required plans and insurers  
            to report to DMHC and CDI specified information related to  
            chronic pain medication management, including when the plan or  
            insurer requires an enroll 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.  (NOTE:  
            This bill was held in the Assembly Appropriations Committee.)


          ARGUMENTS IN SUPPORT: 


          The  US Pain Foundation  (sponsor) writes a letter in support and  
          notes, "Both the persistent lack of access to opioids by  
          patients with legitimate, chronic pain and the rate of  
          prescription opioid abuse exist side-by-side.  Sadly, they also  
          continue to rise.  This is why abuse-deterrent formulations are  
          needed - to help maintain access while reducing abuse risk."


          The  Power of Pain  (co-sponsor) writes a letter in support and  
          reports, "Opioids are an important and well-established  
          component of pain management.  However, misuse and abuse of  
          opioids is a growing public health problem that is driving up  
          healthcare, criminal justice, and workplace costs.  We need to  
          change our policies to develop a strong, lasting solution to  
          this health crisis.  To help combat the problem, a new approach  
          has emerged with the development of opioids with technological  








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          advancements that either prevent physical alterations to the  
          pills or inhibit the euphoric effects of opioids when abused.  
          ADF technology represents a significant opportunity to reduce  
          misuse and abuse of opioids."


          The  California Healthcare Institute  writes a letter in support  
          and highlights, "The innovative technology of Abuse Deterrent  
          Formulations (ADFs) medications provide the same pain relief as  
          conventional opioids but they contain physical or chemical  
          properties that make crushing, cutting or dissolving for  
          injection difficult.  With these new breakthroughs, the FDA  
          considers the development of these products a high public health  
          priority."


           Biocom  writes a letter in supports and cites, "It is  
          unconscionable that a plan could make a recovering addict or an  
          individual at risk of becoming an addict take medication without  
          the abuse deterrent to save a few dollars."


          The  Alliance for Patient Access  writes a letter in support and  
          notes, "Insurances policies should acknowledge physicians'  
          judgment about which formulation a patient needs.  Imposing  
          prior authorization requirements or "fail first" policies to  
          deter physicians from prescribing abuse-deterrent formulations  
          does not serve patients' best interests."


          The  Partnership for Drug-Free Kids  writes a letter in support  
          and cites, "Many have suffered the ultimate tragedy [of misuse  
          or abuse of prescription drugs], the loss of a daughter or son.   
          While advancements like abuse deterrent formulations are not the  
          only solution to solving the nation's prescription drug abuse  
          problem, it is one common-sense approach to potentially help  
          another family from losing a child to addiction."










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          The  California Pharmacists Association  writes a letter in  
          support and notes, "Ensuring the pharmacists inform patients  
          receiving opioid analgesics of the need to store them away from  
          children, adolescents, and other at risk for diversion, and  
          informing patients of the need to properly dispose of controlled  
          substances, will help reduce the number of diverted drugs."


           Healthy African American Families II  writes a letter in support  
          and states, "Having a greater share of the controlled substances  
          in America's medicine cabinets formulated with abuse deterrent  
          properties would be an important step forward to curbing  
          prescription drug abuse while ensuring that these medicines  
          remain available to those who need them for a legitimate medical  
          purpose under a physician's care."


          The  Lupus Foundation of Southern California writes a letter in  
          support and points out, "While AB 623 will not completely stop  
          the abuse of prescription drugs, it does contain some important  
          steps that will reduce it."


          The  California Hepatitis C Task Force  writes a letter in support  
          and claims, "AB 623 will prevent countless deaths from substance  
          abuse alone which includes suicides and accidental overdoses but  
          also consider the secondary impact from communicable, infectious  
          and chronic diseases." 


          ARGUMENTS IN OPPOSITION:


           California Retailers Association  writes a letter in opposition  
          and caution, "While we support innovations to prevent  
          prescription drug abuse, we need to be cautious of mandating the  
          dispensing of these drugs without consideration for efficacy and  
          cost.  Although technological innovations have been developed to  
          prevent opioid medications such as Oxycontin from being crushed,  








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          dissolved, chewed, or cut, this does not entirely prevent abuse  
          and potential overdose because an individual can still ingest  
          opioids without limitation."


           California Chamber of Commerce  writes a letter in opposition and  
          notes, ". . . even though AB 623 allows issuers [sic] to require  
          pre-authorization and apply for other utilization review  
          management protocols to opioids generally, this does not  
          necessarily mean that the measure will not have negative  
          consequences for purchasers and patients.  For example,  
          physicians may increase the rate at which they prescribe opioids  
          over other types of pain medications if they know issuers [sic]  
          are required to cover abuse-deterrent formulations."


           California Association of Health Plans  writes a letter in  
          opposition and cites, "The New England Journal of Medicine  
          concluded in its study of the issue that 'abuse-deterrent  
          formulations may not be the 'magic bullets' that many had hoped  
          they would be in solving the growing opioid problem.'  As such,  
          the overall value of abuse-deterrent drugs is still being  
          evaluated by the FDA."


           Pharmaceutical Management Association  writes a letter in  
          opposition and notes, "AB 623 is part of a nationwide effort to  
          force the use of abuse-deterrent opioid analgesic drug products  
          by disallowing generic substitution of existing opioid drug with  
          an available generic.  The fact is, Abuse Deterrent Formulations  
          (ADFs) are not a quick fix for opioid abuse and will raises  
          costs."


          POLICY ISSUES FOR CONSIDERATION:


          California Health Benefits Review Program (CHBRP) Review.  The  
          Assembly Health Committee referred this bill to the CHBRP for a  








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          comprehensive analysis of the overall impact of the bill.  The  
          committee submitted a request to CHBRP, housed within the  
          University of California, to review this bill and perform an  
          analysis of the clinical efficacy, cost-effectiveness, and  
          public health impact of its provisions.  CHBRP is established in  
          state statute to assess legislation that proposes or repeals a  
          mandated benefit or service for public health, medical and  
          financial impact.  CHBRP's independent analysis will likely  
          provide valuable information about the potential impact of this  
          bill and inform the Legislature on key policy questions  
          regarding the bill.  For example, as a part of its role in  
          determining the cost-effectiveness and public health impacts of  
          the bill, the CHBRP analysis may estimate the cost implications  
          of requiring brand name abuse-deterrent opioids over generic  
          opioids without abuse-deterrent properties.  Additionally, the  
          bill would not require abuse-deterrent drugs to actually  
          demonstrate reduced abuse in the community before requiring  
          plans to cover them where available.  As such, the CHBRP  
          analysis may provide insight into the actual or potential public  
          health impact of abuse-deterrent opioids in the community  
          through an evaluation of a broader set of available evidence.


          Pharmacist Education Provision.  This bill would mandate a  
          pharmacist provide to a patient receiving an opioid analgesic  
          drug product information regarding proper storage and disposal  
          of the drug.  This provision provides that the pharmacist may  
          include this information as part of the mandated oral  
          consultation.  However, the current regulations with limited  
          exceptions allow the patient to waive the oral consultation.    
          After discussion with the BOP, the language of this provision  
          may not result in this information being distributed to every  
          patient being prescribed these medications.  For example, since  
          this provision does not require that the information be placed  
          in written materials, known as a Fact Sheet, a patient receiving  
          a prescription for an opioid drug and who waives the oral  
          consultation might not receive this important information.   
          Because the BOP recognizes the prescription drug abuse epidemic,  
          it is considering tightening regulations relating to  








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          consultation requirements relating to opioids.  After  
          discussions with the author and the sponsors, the committee  
          recommends and the author agrees to amend this section directing  
          the BOP to promulgate regulations so that this information is  
          effectively distributed to targeted patients.  


          30-day Supply Provision.  Currently there is no requirement in  
          existing law that gives a plan or insurer the authority to  
          require a health care provider to write for a certain amount of  
          medication.  The health care provider is free to prescribe a  
          quantity as deemed medically necessary and within the standard  
          of care.  However, the DEA limits Schedule II controlled  
          substances to less than a 90-day supply and requires a new  
          prescription for continuation of the medication.  Notably, there  
          is a provision in the insurance regulations that gives a plan or  
          insurer the authority to require a 60-day or more supply for  
          maintenance medication.  To be clear, this regulation does not  
          prevent a health care provider from writing a prescription for  
          any amount as deemed necessary for the condition being treated  
          but could be grounds for denial of payment for a prescription  
          for a maintenance opioid that is prescribe for less than sixty  
          days.  The language in the bill suggests that a plan or insurer  
          has the ability to mandate the prescribing habits of health care  
          providers.  After several discussions with the author, the  
          sponsors, the Medical Board of California, BOP, and the  
          California Medical Association, the origin and intent of this  
          section remains unclear and confusing.  At this point, the  
          author would appreciate more time to investigate the intent of  
          this section and agrees to clarify the language or delete these  
          sections as appropriate. 


          AMENDMENTS:


          On page 3, line 15-17 strike out This information may be  
          included as part of the oral consultation required under Section  
          1707.2 of Title 17 of the California Code of Regulations.  and  








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          following the period after the word "drug" insert:  The Board  
          shall promulgate regulations to implement this section.  
          


          REGISTERED SUPPORT:  


          US Pain Foundation (sponsor)


          Power of Pain (co-sponsor)


          Biocom


          Alliance for Patient Access


          California Healthcare Institute


          California Hepatitis C Task Force


          California Pharmacists Association


          California State Sheriffs' Association


          Healthy African American Families II


          Lupus Foundation of Southern California


          Partnership for Drug-Free Kids








                                                                     AB 623


                                                                     Page 22









          REGISTERED OPPOSITION:  
          California Retailers Association


          California Chamber of Commerce


          California Association of Health Plans


          Pharmaceutical Management Association




          Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301,   
          Christian Jagusch / B. & P. / (916) 319-3301