BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  AB 1917
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          Date of Hearing:  April 29, 2014

                            ASSEMBLY COMMITTEE ON HEALTH
                                 Richard Pan, Chair
                 AB 1917 (Gordon) - As Introduced:  February 19, 2014
           
          SUBJECT  :  Outpatient prescription drugs: cost sharing.

           SUMMARY  :  For nongrandfathered individual and group health  
          coverage which cover essential health benefits (EHBs), limits  
          enrollee cost sharing, such as copayments and coinsurance, for  
          outpatient prescription drugs to no more than 1/24 of the total  
          annual out-of-pocket limit for all EHBs, as specified.   
          Specifically,  this bill  :  

          1)Limits cost sharing for outpatient prescription drugs in  
            nongrandfathered, individual and small group health benefit  
            plans required to provide EHBs, and subject to statutory  
            maximum annual cost sharing charges, to no more than 1/24 of  
            the total annual out-of-pocket limit for all EHBs, for up to a  
            30 day supply. 

          2)For a high deductible health plan (HDHP), as defined under  
            federal tax rules, would require the cost sharing limit be  
            applied once an enrollee's deductible for the plan year is  
            satisfied.

          3)Limits the total cost sharing for individuals eligible for  
            cost sharing reductions (CSRs) under the federal Patient  
            Protection and Affordable Care Act (ACA) (Public Law 111-148)  
            to no more than 1/24 of the annual out-of-pocket limit in the  
            cost sharing reduction plan.

          4)Specifies that the requirements of 1) not be construed to  
            affect individuals entitled to ACA CSRs and excludes Medicare  
            health plans from the out-of-pocket limit in this bill.

          5)Defines outpatient prescription drugs for purposes of this  
            bill to mean, "a drug approved by the federal Food and Drug  
            Administration that is self-administered by a patient,  
            administered by licensed health care professional in an  
            outpatient setting, or administered in a clinical setting that  
            is not an outpatient setting."

           EXISTING LAW  :  








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          1)Establishes the Department of Managed Health Care (DMHC) to  
            regulate health plans and the California Department of  
            Insurance (CDI) to regulate health insurers.

          2)Requires health plans and insurers providing health coverage  
            in the individual and small group markets to cover, at a  
            minimum, EHBs, including the ten EHB benefit categories in the  
            ACA, (one of which is prescription drugs), and consistent with  
            California's EHB benchmark plan, the Kaiser Foundation Health  
            Plan Small Group HMO 30 plan (Kaiser benchmark), as specified  
            in state law.  EHB prescription drug coverage offered, sold  
            and renewed by health plans and insurers after January 1,  
            2014, is subject to specified California statutory and  
            regulatory standards which predated the ACA and applied to  
            health plans under the jurisdiction of DMHC, including the  
            Kaiser benchmark. 

          3)Requires, in 2014, non-grandfathered individual and group  
            coverage covering EHBs to limit annual out-of-pocket expenses  
            for covered EHBs (except for pediatric oral care) to $6,350  
            for an individual and $12,700 for family coverage.  For  
            specialized health insurance policies or health plan contracts  
            covering pediatric oral care, health plans and insurers must  
            limit the annual maximum to $1,000 for one child and $2,000  
            for more than one child.  In 2015 and subsequent years,  
            non-grandfathered individual and group coverage must limit  
            annual out-of-pocket expenses for covered EHBs (including  
            pediatric oral care) to the federal annual limit for  
            out-of-pocket expenses in health savings account (HSA)  
            coverage for 2014, adjusted annually based on the average  
            increase in health insurance premiums, pursuant to the ACA and  
            implementing federal rules.

          4)Establishes in federal law the ACA which, among other  
            provisions: 

             a)   Establishes federal premium tax credits and CSRs for  
               eligible low- and moderate-income individuals purchasing  
               coverage in state exchanges, and imposes specified annual  
               limits on consumer out-of-pocket costs unless the coverage  
               is specifically grandfathered in the ACA.

             b)   Requires issuers of individual and small group coverage  
               to, at a minimum, cover EHBs in the following 10  








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               categories: Ambulatory patient services, emergency  
               services, hospitalization, maternity and newborn care,  
               mental health and substance use disorder services,  
               including behavioral health treatment, prescription drugs,  
               rehabilitative and habilitative services and devices,  
               laboratory services, preventive and wellness services and  
               chronic disease management, and pediatric services,  
               including oral and vision care.

             c)   Requires states to select a "benchmark plan" to serve as  
               the minimum coverage standard for EHBs, choosing from among  
               specified employer plans offered in the state.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal  
          committee.

           COMMENTS  :

           1)PURPOSE OF THIS BILL  .  According to information provided by  
            the author's office, this bill directly benefits Californians  
            by annualizing prescription drug cost sharing so that patients  
            with expensive medications will not be forced to pay high  
            upfront costs.  Instead, Californians will be given the  
            opportunity to budget and plan for these costs throughout the  
            year and will be protected from financial ruin.  Patients who  
            need high cost life-saving prescription drugs can reach the  
            limit in the first month of the plan.  This bill would help  
            Californians who live paycheck to paycheck as well as  
            individuals and families who do not qualify for any cost  
            sharing subsidies under the ACA (those who have an annual  
            income at or above 250% of the Federal Poverty Level (FPL)),  
            $29,175 annual income for a single individual and $59,625 per  
            year for a family of four.  

           2)BACKGROUND  .  

             a)   California Health Benefits Review Program.  The  
               California Health Benefits Review Program (CHBRP) reviewed  
               this bill at the request of this Committee.  The key  
               findings of the CHBRP report are:

                 i)       Enrollees covered.  CHBRP estimates that in  
                   2015, 11.7 million of 23.4 million Californians with  
                   state-regulated health insurance would have coverage  
                   that would be subject to this bill.  Medi-Cal managed  








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                   care plans and grandfathered plans and policies are not  
                   subject to this bill. 
                 ii)      Impact on expenditures.  This bill would  
                   increase expenditures in California by an estimated  
                   $106.1 million in the nongrandfathered group and  
                   individual market (excluding CSRs). 
                 iii)     Premiums.  Increases in per member per month  
                   premiums are estimated to range from an average of  
                   0.047% (for DMHC-regulated large-group plans) to an  
                   average of 0.661% (for CDI-regulated individual market  
                   policies). 
                 iv)      Enrollee out-of-pocket expenses.  This bill  
                   would shifts costs from enrollees to health plans and  
                   insurers. Enrollee out-of-pocket expenses would be  
                   reduced by an estimated $21.8 million. 
                 v)       Medical effectiveness.  Overall, there is strong  
                   evidence that persons who face higher cost sharing  
                   reduce use of both essential and nonessential services.  
                    For prescription drugs, there is evidence that as cost  
                   sharing increases for prescription drugs, including  
                   specialty prescription drugs, usage decreases. 
                 vi)      Benefit coverage.  This bill would apply to all  
                   outpatient prescription drugs; however, the mandate is  
                   estimated to have the greatest impact on high cost  
                   and/or specialty drugs.  All enrollees subject to this  
                   bill have coverage for outpatient prescription drugs,  
                   as broadly defined by this bill, and all have some form  
                   of cost sharing for these drugs. 
                 vii)     Utilization.  The limit on cost sharing in this  
                   bill would increase utilization of high cost and/or  
                   specialty drugs, both by enrollees using these  
                   prescription drugs premandate, as well as by new users  
                   who will being using these drugs due to the lower cost  
                   sharing levels postmandate. Utilization would increase  
                   2%, and there would be an estimated 947 new users  
                   (premandate, 45,410; postmandate, 46,357). 
                 viii)    Public health.  CHBRP projects no measurable  
                   public health impact due to the small percentage of  
                   enrollees utilizing high cost and/or specialty  
                   prescription drugs with cost sharing that would be  
                   lowered as a result of this bill (0.42%).  However,  
                   CHBRP recognizes that on a case-by-case basis, this  
                   bill may yield important health and quality of life  
                   improvements and could significantly impact disease  
                   progression and outcomes for affected individuals. 








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                 ix)      EHBs.  State rules related to cost sharing do  
                   not meet the definition of state benefit mandates that  
                   could exceed EHBs under the ACA; therefore, this bill  
                   would not exceed EHBs and would not require the state  
                   to defray the costs of this mandate for enrollees in  
                   the exchange. 
                 x)       CSRs.  Enrollees eligible for CSRs under the ACA  
                   have incomes between 100-250% of FPL and must enroll in  
                   a silver metal level qualified health plan in Covered  
                   California.  These products have reduced cost sharing,  
                   including a lower annual out-of-pocket maximum.  CHBRP  
                   estimates there will be 730,000 enrollees in CSRs in  
                   California in 2015.  The monthly cost sharing limit on  
                   all covered benefits required by this bill would change  
                   the benefit design of these products, potentially  
                   bringing them out of compliance with ACA requirements.   
                   Therefore, CHBRP cannot estimate the impact of this  
                   bill on benefit coverage, utilization, cost, and public  
                   health for CSRs. 

             b)   Specialty drugs and cost sharing tiers.  According to  
               CHBRP, prescription drug benefits are a specific type of  
               covered benefit usually subject to cost sharing as part of  
               the medical benefit or a separate outpatient prescription  
               drug benefit.  The separate drug benefit designs can be  
               characterized by the number of tiers (up to four) into  
               which drug classes and specific medications are assigned.   
               Each tier has a distinct cost sharing level and/or form;  
               the lower tiers are less costly to both the enrollee and to  
               the health plan or insurer.  Some payers use a four-tier  
               system which includes life-style drugs and specialty drugs  
               in the fourth tier; typically these are the most costly  
               drugs.  The four-tier design frequently results in greater  
               enrollee out-of-pocket expenses.  CHBRP notes that there is  
               no standard industry definition of specialty prescription  
               drugs, but it is generally recognized by many payers as  
               prescription drugs with an average minimum monthly cost of  
               $1,150.  Other criteria may include prescription drugs that  
               treat a rare disease, require special handling, or have a  
               limited distribution network.  Most of the conditions  
               targeted by these specialty drugs tend to be chronic and  
               progressive in nature and can impact quality of life, along  
               with morbidity and mortality.  Examples include growth  
               hormone disorders, rheumatoid arthritis, asthma, multiple  
               sclerosis, hepatitis C, hemophilia, cancer, and lupus.  








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             In 2013, the annual California HealthCare Foundation employer  
               benefits survey found that 66% of covered California  
               workers had a three- or four-tier cost sharing formula for  
               prescription drugs.  Nationally, 82% of covered workers  
               were subject to three- or four-tier formulas.

             c)   CSRs.  Under the ACA, CSRs reduce deductibles,  
               copayments, coinsurance and total out-of-pocket spending  
               limits for people with incomes up to 250% FPL ($59,625 for  
               a family of four in 2014).  CSRs will be applied  
               automatically for consumers who qualify based on their  
               income, but only if they buy a silver-level plan, the ACA  
               benchmark for premium tax credits and CSRs.   Silver plans  
               are one of the four levels of coverage (in addition to  
               catastrophic coverage), sometimes referred to as the  
               precious metals (bronze, silver, gold, and platinum), being  
               offered in the reformed individual and small group markets,  
               including the exchange, based on actuarial values of the  
               coverage at each level.  A silver plan will generally pay  
               70% of covered medical expenses, leaving the consumer  
               responsible for 30% (bronze (60%), gold (80%) and, platinum  
               (90%)).  

             The federal CSRs essentially increase the insurers' share of  
               covered benefits, resulting in reduced out-of-pocket  
               spending for lower-income consumers. Insurers will be  
               reimbursed by the federal government for the CSRs.  A  
               family of four whose income is between 100% and 150% FPL  
               ($23,850 to $35,775) will be responsible for paying 6% of  
               covered expenses out-of-pocket compared with the 30% that a  
               family not getting CSRs would owe in a silver plan.  A  
               family with an income between 150% and 200% FPL ($35,775 to  
               $47,700) will be responsible for 13% of expenses, and  
               families between 200% and 250% FPL ($47,700 to $59,625)  
               will be responsible for 27% of expenses. 

             In addition, people who earn 250% FPL eligible for CSRs will  
               have their maximum out-of-pocket spending capped at lower  
               levels than will be the case for others who buy plans on  
               the exchange.  In 2014, the out-of-pocket limits for most  
               plans will be $6,350 for an individual and $12,700 for a  
               family but people who qualify for CSRs will see their  
               maximum out-of-pocket spending capped at $2,250 or $4,500  
               for single or family coverage, respectively, if their  








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               incomes are less than 200% FPL, and $5,200 or $10,400 if  
               their incomes are between 200% to 250% FPL.  

             In Covered California, in 2014, a standard silver plan has a  
               $2,000 deductible, a $6,400 maximum out-of-pocket limit and  
               a $45 copayment for a primary care office visit.  CSR  
               eligible individuals whose income is between 150% and 200%  
               FPL, on the other hand, has a silver plan with a $500  
               deductible, a $2,250 maximum out-of-pocket limit and $15  
               copays for primary care doctor visits.  This bill would  
               reduce the monthly out-of-pocket limit for individuals on  
               CSR plans to 1/24 of the cost sharing limit. 

             d)   High deductible health plan.  An HDHP is a health plan  
               product that combines an HSA or a Health Reimbursement  
               Arrangement with traditional medical coverage, providing a  
               tax benefit for covered individuals.  The Internal Revenue  
               Service announced that for calendar year 2014, a "high  
               deductible health plan" is defined as a health plan with an  
               annual deductible that is not less than $1,250 for  
               self-only coverage or; $2,500 for family coverage; and,  
               annual out-of-pocket expenses (deductibles, co-payments,  
               and other amounts, but not premiums) do not exceed $6,350  
               for self-only coverage or $12,700 for family coverage.   
               HDHP coverage levels are adjusted annually by the IRS.

           3)SUPPORT  .  Health Access California, sponsor of this bill,  
            offers that the emergence of very high cost specialty drugs  
            which are increasingly offered on an outpatient basis, such as  
            chemotherapy, has led health plans and insurers to impose high  
            copayments and coinsurance on the necessary medications.   
            Californians with HIV/AIDS, hepatitis, cancer, multiple  
            sclerosis, or other serious conditions often face costs of  
            thousands of dollars where fourth-tier drug coinsurance can be  
            10%-20% of the drug costs.  Under these conditions, patients  
            must exhaust their entire annual out-of-pocket limit in the  
            first month.  According to Health Access, asking someone to  
            spend $6,000 for a single prescription upfront is unrealistic.  
             This is particularly true for those who make less than  
            $45,000, the median income in California.  Spreading these  
            costs out over the course of a year is reasonable and allows  
            Californians to budget and plan for the cost of their care,  
            and will prevent financial hardship and bankruptcy, the intent  
            of the ACA and the out-of-pocket limit provision.  Patient  
            advocacy groups support this bill stating that the cost burden  








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            for specialty drugs adds to the challenges of dealing with  
            life threatening and chronic diseases. These organizations  
            point out that people with serious and chronic diseases have  
            very high medical expenses and make frequent health care  
            visits.  For example, there are 10 injectables and three oral  
            medications used to help manage multiple sclerosis.  The  
            medications have no generic substitutes and are typically  
            placed on specialty drug tiers with higher cost sharing.   
            Western Center on Law and Poverty writes in support of this  
            bill that sometimes individuals can work out payment plans  
            with health plans or providers but in many cases they do not  
            have the money to purchase the medication and must go without.  
             

          4)SUPPORT IN CONCEPT  .  The California Chronic Care Coalition  
            (Coalition) has adopted a position of support in concept on  
            this bill.  The Coalition agrees with the basic premise of  
            this bill that many specialty medications are so expensive  
            that the average patient either cannot afford to purchase the  
            medications or does purchase them at the exclusion of other  
            needs such as rent, the mortgage, or even food.  These life or  
            death issues are made by thousands of Californians every day.   
            The Coalition states that this bill deals with the most  
            visible part of the problem - the cost to the patient - but  
            just as important are the resulting potential added costs to  
            health plans, insurance companies, the Medi-Cal program,  
            employers, employees, pharmacists, providers, medical groups,  
            pharmaceutical companies, HR managers, labor unions (which  
            represent employees in bargaining for health and wage  
            benefits), and the taxpayer.  The Coalition is also concerned  
            that the proposed maximum monthly in this bill, $250 to $265 a  
            month for a single prescription, is too high.  The Coalition  
            cites a Prime Therapeutics study released on April 2, 2014  
            which found that pharmacy plan members with specialty drug  
            out-of-pocket costs less that $250 are more likely to start  
            taking their medication than those with higher out-of-pocket  
            expenses.  As costs rise, the study found consumers are more  
            likely to abandon taking their medication as prescribed  
            leaving them at risk.  The Coalition would like to see this  
            bill kept alive in the legislative process so it can be used  
            as a vehicle for major reforms after a Coalition- sponsored  
            stakeholder forum on specialty medications scheduled for May  
            29, 2014.

           5)OPPOSITION  .  Health plans and insurers oppose this bill  








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            arguing it will increase health insurance premiums,  
            arbitrarily require changes in the Covered California standard  
            benefit designs and do nothing to control the dramatic rise in  
            prescription drug costs. The California Association of Health  
            Plans (CAHP) writes in opposition to this bill because it  
            legislatively sets a per-prescription cap for all outpatient  
            drugs. This across-the-board price regulation is not related  
            to the underlying cost of health care and is unreasonable  
            considering the very high cost of many drugs and services.   
            CAHP points out that prescription drugs represent a  
            significant 16% of the health care premium dollar and the  
            underlying cost of drugs deserves immediate attention.   
            According to CAHP, drug spending in California nearly doubled  
            from 1991 to 2009, reaching $24.4 billion (10.5% of all health  
            care spending).  CAHP notes that the high-cost of specialty  
            medications to treat complex and rare conditions could outpace  
            all of the recent savings from the expanded use of generic  
            drugs for common conditions like high cholesterol and high  
            blood pressure.  The Pharmaceutical Care Management  
            Association opposes this bill because it will increase costs  
            both inside and outside of Covered California, gives branded  
            drug manufacturer's a free ride on endless price increases,  
            and the requirements of this bill would be extremely complex  
            and costly to administer. Association of California Life and  
            Health Insurance Companies (ACLHIC) that under the ACA  
            actuarial value standards lowering cost sharing for one  
            benefit will necessarily increase cost sharing for other  
            services.  ACLHIC believes that this bill will only shift the  
            burden and socialize the costs of expensive drugs to all rate  
            payers. 

           6)PREVIOUS LEGISLATION  .  

             a)   SB 639 (Ed Hernandez), Chapter 316, Statutes of 2013,  
               enacts implementing state law related to ACA out-of-pocket  
               limits on health plan enrollee and insured cost sharing,  
                                                                                            health plan and insurer actuarial value coverage levels and  
               catastrophic coverage requirements, and requirements on  
               health insurers with regard to coverage for out-of-network  
               emergency 
             services. 

             b)   AB 219 (Perea), Chapter 661, Statutes of 2013, limits  
               the total amount of copayments and coinsurance an enrollee  
               or insured is required to pay for orally administered  








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               anticancer medications to $200 for an individual  
               prescription of up to a 30-day supply.

             c)   SB 842 (Speier), Chapter 791, Statutes of 2002, required  
               DMHC to develop standards for health plan that cover  
               prescription drugs, including standards to be used by DMHC  
               in reviewing a health plan's request for approval of  
               proposed copayment, deductible, limitations, or exclusions  
               for prescription drug benefits.

           7)TECHNICAL AMENDMENTS.   The definition of outpatient drugs in  
            this bill does not specify that the drug must require and be  
            dispensed by a prescription, or be covered by the contract or  
            policy, to be subject to the cost sharing limits in this bill.  
             The definition of outpatient prescription drugs in this bill  
            should be amended to make those clarifying changes.

           8)AUTHOR'S AMENDMENTS  .  The author intends to offer the  
            following amendments in Committee: 

             a)   Eliminate the limit on out-of-pocket costs for  
               individuals eligible for ACA CSRs;
             b)   Spread the cost sharing out over the course of  
               treatment;
             c)   Clarify that the limits on out-of-pocket costs in  
               specialized health plan contracts and insurance policies  
               (dental-only, vision-only, mental health-only, etc.) only  
               applies if the specialized health plans covers EHBs; and
             d)   Authorize DMHC and CDI to adjust the requirements in  
               this bill if necessary to comply with federal or state  
               actuarial value requirements; and,
             e)   Delay the effective date of this bill until July 1, 2015  
               for the group market and until January 1, 2016 for the  
               individual market.

           REGISTERED SUPPORT / OPPOSITION  :  

           Support 
           
          Health Access California (sponsor)
          American Federation of State, County and Municipal Employees,  
          AFL-CIO
          California Healthcare Institute
          California Pharmacists Association
          California Teachers Association








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          CALPIRG
          National Alliance for the Mentally Ill, California
          National Multiple Sclerosis Society, California Action Network
          Western Center on Law and Poverty

           Opposition 
           
          Aetna
          America's Health Insurance Plans
          Anthem
          Association of California Life and Health Insurance Companies
          California Association of Health Plans
          California Chamber of Commerce
          Pharmaceutical Care Management Association

          
          Analysis Prepared by  :    Deborah Kelch / HEALTH / (916) 319-2097