BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      AB 1124


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          ASSEMBLY THIRD READING


          AB  
          1124 (Perea)


          As Amended  June 1, 2015


          Majority vote


           ------------------------------------------------------------------- 
          |Committee       |Votes |Ayes                  |Noes                |
          |----------------+------+----------------------+--------------------|
          |Insurance       |12-0  |Daly, Beth Gaines,    |                    |
          |                |      |Calderon, Cooley,     |                    |
          |                |      |Cooper, Dababneh,     |                    |
          |                |      |Frazier, Gatto,       |                    |
          |                |      |Gonzalez, Grove,      |                    |
          |                |      |Mayes, Rodriguez      |                    |
          |                |      |                      |                    |
          |----------------+------+----------------------+--------------------|
          |Appropriations  |12-0  |Gomez, Bonta,         |                    |
          |                |      |Calderon, Daly,       |                    |
          |                |      |Eggman, Eduardo       |                    |
          |                |      |Garcia, Gordon,       |                    |
          |                |      |Holden, Quirk,        |                    |
          |                |      |Rendon, Weber, Wood   |                    |
          |                |      |                      |                    |
          |                |      |                      |                    |
           ------------------------------------------------------------------- 


          SUMMARY:  Requires the Division of Workers Compensation to adopt a  
          prescription drug formulary for workers compensation benefits.   
          Specifically, this bill:  









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          1)Requires the Administrative Director of the Division of Workers  
            Compensation to develop a prescription drug formulary.


          2)Requires the Administrative Director to convene an advisory  
            committee to assist in the development of the formulary.


          3)Requires the recommendations of the advisory committee to  
            address the following issues:


             a)   Providing injured workers access to appropriate opioids  
               and other pain management drugs.


             b)   Providing workers receiving potentially addictive drug  
               treatment with gradual detoxification programs.


             c)   Ensuring timely updates to the formulary.


          EXISTING LAW:  


          1)Requires employers to provide medical treatment to an injured  
            worker that is reasonably required to cure or relieve an injury  
            that occurs on the job.


          2)Requires the Administrative Director to adopt a medical  
            treatment utilization schedule (MTUS) that addresses the  
            frequency, duration, intensity, and appropriateness of all  
            treatment procedures and modalities commonly performed in  
            workers compensation cases.










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          3)Provides that the MTUS is presumptively correct on the extent  
            and scope of treatment for workers' compensation patients.  This  
            presumption is rebuttable by proving with a preponderance of the  
            evidence that a treatment is reasonably required to cure or  
            relieve the injured worker.


          4)Requires pharmacies to dispense generic drug equivalents for  
            workers' compensation patients unless the prescriber expressly  
            prohibits it.


        FISCAL EFFECT:  According to the Assembly Appropriations Committee:


          1)$500,000 to the Division of Workers' Compensation for contract  
            expertise to develop a formulary (Workers Compensation  
            Administration Revolving Fund).  Annual ongoing costs are  
            expected to be similar. 


          2)A statewide formulary will likely result in significant savings,  
            from lower pricing and more appropriate and reduced utilization.  
             The California Workers Compensation Institute published a study  
            in November 2014 evaluating the potential impact of adopting a  
            workers' compensation formulary in California.  The study found  
            that applying the workers' compensation formularies adopted in  
            Texas and Washington could reduce California workers'  
            compensation payments for between $124 and $420 million per  
            year.  Both Texas and Washington adopted formularies in response  
            to sustained, double-digit growth in their workers' compensation  
            prescription drug costs. 


          COMMENTS:  


          1)Purpose.  According to the author, current law is unclear if the  
            Administrative Director has authority to establish a  








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            prescription drug formulary in the workers' compensation system.  
             This bill is needed to give the Administrative Director clear  
            authority to establish a formulary, control rising prescription  
            drug costs in California's workers' compensation system, limit  
            the over-prescribing of highly-addictive opioids, and ensure  
            injured workers get the necessary treatment needed to get back  
            to work. 


          2)Formularies.  Drug formularies have proven to be very effective  
            at managing the cost of prescription drugs.  Health plans have  
            been using formularies in California for decades and they are  
            commonly accepted as a useful cost control mechanism.  They  
            control costs by limiting the utilization of high priced drugs  
            and reducing the price of drugs.  Formularies are usually  
            developed by companies known as pharmaceutical benefits managers  
            (PBMs) who design formularies and manage prescription drug  
            benefits for a contracting health plan.  At the most basic level  
            a formulary is a list of drugs that a health plan or insurer  
            agrees to cover.  However, formularies are not simply arbitrary  
            limits on drug use.  Formularies must be broad enough to provide  
            drug treatment options when they are available, and formulary  
            decisions are guided substantially by the scientific evidence  
            regarding individual drugs.  However, in most cases there are  
            multiple drugs available to treat a given condition and  
            formularies are constructed to drive treatment choices to the  
            most cost-effective option.  


            Formularies use a number of strategies to control costs driven  
          by utilization including:


             a)   Quantity Restrictions - formularies commonly prohibit  
               dispensing a greater quantity of the drug than is typically  
               necessary.  Antibiotics and opioids are examples of drug  
               categories where there have been historical patterns of  
               overprescribing and abuse that can be addressed by quantity  
               restrictions.








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             b)   Refill Restrictions - formularies commonly will not allow  
               a prescription to be refilled until the period of time that  
               the initial prescription was expected to last has elapsed.  


             c)   Use of Generics - formularies commonly will not include a  
               name brand drug if there is a generic version of that drug  
               available.  Generic drugs are chemically identical to a name  
               brand drug but typically are available at dramatically lower  
               prices.  


             d)   Category Restrictions - formularies can also exclude some  
               categories of drugs entirely, generally because there are  
               drugs in other categories that are more effective.  


             e)   Prior Authorization - formularies also commonly impose  
               prior authorization requirements on certain drugs because of  
               the high cost of the drug or because some drugs have common  
               non-therapeutic uses.  Drugs requiring prior authorization  
               are covered by the formulary, but only after the prescriber  
               has established a medical need for the drug.  Prior  
               authorization is commonly used for expensive biotech drugs  
               prescribed for serious conditions and for drugs that have  
               common cosmetic or recreational uses.


             f)   Step-therapy - formularies commonly require that a  
               prescriber begin therapy with the lowest cost drug in a  
               category and demonstrate the drug failed to remediate the  
               problem before prescribing higher cost drugs in the category.  
                In many categories there are less expensive (generally  
               older) but comparable drugs available and step-therapy  
               requirements push treatment to these drugs but allow for a  
               more expensive (generally newer) drug if the cheaper drug  
               doesn't work for the individual patient.  








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             g)   Co-Payments - formularies outside of workers compensation  
               almost always include a patient "co-payment" for each  
               prescription.  In the mainstream world of health plans, a  
               tiered structure of co-payments is commonly used where the  
               lowest co-payment is for generic drugs, a higher co-payment  
               is for the preferred branded drug, and non-preferred branded  
               drugs are subject to a still higher co-payment.  Typically  
               these co-payment structures are steeply slanted to create  
               financial incentives for patients to choose a generic or  
               lower cost branded drugs over higher cost alternatives.  This  
               structure is also commonly referred to as an "open"  
               formulary.  


            Formularies are constructed to drive treatment to the most  
            cost-effective options for treating the group of patients as a  
            whole.  However, formularies do generally include provisions for  
            prescribing outside the formulary after the prescriber has  
            established that the formulary restrictions are not appropriate  
            for an individual patient.  


            In addition to using these strategies designed to control the  
            utilization of drugs, PBMs also use formulary construction to  
            reduce the price of drugs.  By aggregating the purchasing power  
            of multiple health plans, a PBM can negotiate discounts from  
            competing drug manufacturers.  By making a particular drug in a  
            category the preferred drug on the formulary, the PBM can  
            increase the sales volume of that particular drug and many  
            manufacturers are prepared to offer favorable pricing to secure  
            the added volume of sales.  The combination of utilization  
            controls and the exercise of market power to reduce pricing has  
            been effective and made formularies a pillar of managed care.  


          3)Why A Formulary?  Drug costs have been growing significantly in  
            the workers compensation system in recent years (especially the  








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            cost of opioids which is discussed in greater detail below) and  
            formularies have a proven track record of reducing drug costs in  
            other states.  As noted above, formularies work both by both  
            restricting utilization of higher cost drugs and reducing the  
            cost of drugs and present a logical alternative to restrain the  
            increasing cost of drugs in the workers compensation system.   
            This would be particularly true for workers' compensation as  
            there is no financial incentive for prescribers or patients in  
            the system to control drug utilization or to have cost factor  
            into prescribing decisions.  The absence of copayments in the  
            workers' compensation system also means that the tiered  
            copayment structure (what is also referred to as an open  
            formulary) will be ineffective in the workers' compensation  
            system.  However, a closed formulary does not rely on the  
            financial incentive of a copayment to influence drug utilization  
            and would be required for any formulary to be effective in  
            workers' compensation. 


          4)CWCI Study.  The California Workers Compensation Institute (a  
            highly regarded industry research organization) published a  
            study in November of 2014 that evaluated the potential impact of  
            adopting a workers compensation formulary in California.  The  
            study found that applying the workers compensation formularies  
            adopted in Texas and Washington could reduce California workers'  
            compensation payments for non-formulary drugs between $124 and  
            $420 million per year.  Both Texas and Washington adopted  
            formularies in response to sustained, double-digit growth in  
            their workers' compensation prescription drug costs. 


            The Texas formulary was phased in beginning in September 2011,  
            with initial implementation for new injuries and subsequent  
            expansion to legacy claims.  It had an immediate impact.  In the  
            first year, non-formulary drug payments fell by 82% (from 17% to  
            4% of total drug expenditures) and the number of prescriptions  
            fell 74%. 










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            Washington implemented its formulary in 2004, and it also had a  
            significant effect on the utilization and cost of workers'  
            compensation prescription drugs.  A 2011 Workers' Compensation  
            Research Institute (WCRI) study found average prescription  
            payments per claim in Washington were significantly lower than  
            the median cost in 17 other states.  According to the WCRI,  
            Washington has lower drug prices for several reasons, including:  
            a pharmacy fee schedule; mandatory generic substitution; and a  
            formulary, which mandated substitution of generic alternatives  
            when no generic equivalents are available.  The WCRI study also  
            looked at prescription drug payments from California's workers  
            compensation system and found that the California exceeded the  
            average prescription payment per claim of the 17 other study  
            states by 80%.


          5)Opioids.   CWCI has also produced a significant volume of  
            research documenting the rapid escalation in the use (and  
            associated cost) of opioids in workers' compensation.  Opioids  
            include powerful painkillers such as morphine, fentanyl,  
            oxycodone, codeine, and hydrocodone.  Opioid use has been rising  
            nationwide and there is a well-documented problem with abuse of  
            and addiction to these prescription painkillers, and workers'  
            compensation patients are not excluded from this phenomenon.   
            According to a recent CWCI report,  


                The findings show that in the first half of 2013, Schedule  
               II opioids, which include powerful narcotics such as  
               oxycontin, fentanyl and morphine, have grown to 7.3 percent  
               of California workers' compensation prescriptions - nearly  
               6 times the proportion noted in 2002.  Over the same  
               period, payments for these drugs have increased from 4.7  
               percent to 19.6 percent of California workers' compensation  
               prescription dollars.  The data also suggest that the use  
               of Schedule II drugs in workers' compensation may have  
               stabilized near this record level, as over the most recent  
               3-1/2 years these drugs have accounted for between 6.5 and  
               7.3 percent of all prescriptions dispensed to injured  








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               workers, while over the most recent 4-1/2 years Schedule II  
               drug payments have represented about 1 out of every 5  
               dollars paid for workers' compensation prescriptions in  
               California.  The findings also show that since 2002, less  
               powerful Schedule III opioids - primarily Vicodin or other  
               forms of hydrocodone compounded with a non-steroidal drugs  
               such as acetaminophen - have accounted for a much more  
               consistent share of workers' compensation prescription  
               drugs, generally representing around 20 percent of all  
               prescriptions dispensed to injured workers and 10 to 11  
               percent of the overall drug spend.


            A workers' compensation formulary would likely have a powerful  
            impact on the spiraling use of opioids.  The utilization control  
            mechanisms such as quantity and refill restrictions, prior  
            authorization requirements, and step therapy requirements are  
            all likely to be very effective at weeding out cases with  
            excessive opioid use and potential abuse.  Pain medication is  
            always going to be present at a meaningful level in occupational  
            medicine given the nature of occupational injuries, but there is  
            compelling evidence that there are far more workers on long  
            term, high-dose opioid therapy than would is consistent with  
            sound medical practice.  In this area a formulary is likely to  
            both reduce costs and improve the quality of care received by  
            workers suffering from chronic pain.


          6)Work In Progress.  Most stakeholders agree that a  
            well-constructed formulary for workers' compensation has the  
            prospect of controlling costs and providing quality care to  
            injured workers.  Like any change to a very complicated workers'  
            compensation system of providing healthcare, establishing a  
            formulary is a complex venture and will require stakeholders to  
            work over the coming months to arrive a fully formed solution.   
            This perspective is not universally subscribed to.  The  
            California Applicants Attorneys Association argues that  
            establishing a formulary is just another in a long line of take  
            aways from injured workers.








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          Analysis Prepared by:                                               
          Paul Riches / INS. / (916) 319-2086  FN: 0000791