BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       AB 1917
          AUTHOR:        Gordon
          AMENDED:       May 23, 2014
          HEARING DATE:  June 18, 2014
          CONSULTANT:    Boughton

           SUBJECT  :  Outpatient prescription drugs: cost sharing.
           
          SUMMARY  :  Establishes limits on the copayment, coinsurance, or  
          any other form of cost sharing for a covered outpatient  
          prescription drug for an individual prescription of 1/12  
          (equivalent to $529 for 2014) or  ($3,175 for 2014) of the  
          annual out-of-pocket limit (which is $6,350 for 2014), as  
          specified under the federal Patient Protection and Affordable  
          Care Act with respect to a non-grandfathered individual or group  
          health plan contract or insurance policy.
           
          Existing law:
          1.Regulates health plans through the Department of Managed  
            Health Care (DMHC) and health insurance policies through the  
            California Department of Insurance (CDI).  

          2.Mandates the 10 federally required Essential Health Benefits  
            (EHBs) and establishes Kaiser Small Group health plan as  
            California's EHB benchmark plan.
           
          3.Requires, on or after January 1, 2015, for non-grandfathered  
            health plan contracts or health insurance policies in the  
            individual and small group markets, to provide for a limit on  
            annual out-of-pocket expenses for all covered benefits that  
            meet the definition of EHB, including out-of-network emergency  
            care, as specified.  For large group, requires a  
            non-grandfathered health plan or health insurer to provide for  
            a limit on annual out-of-pocket expenses for covered benefits,  
            including out-of-network emergency care, as specified.   
            Requires this limit to only apply to EHBs that are covered  
            under the plan or policy to the extent that this provision  
            does not conflict with federal law or guidance on  
            out-of-pocket maximums.

          4.Requires the maximum out-of-pocket limit to apply to any  
            copayment, coinsurance, deductible and any other form of cost  
            sharing for all covered benefits that meet the definition of  
                                                         Continued---



          AB 1917 | Page 2




            EHB.  

          5.Limits the total maximum out-of-pocket limit for all EHBs to  
            the dollar amounts in effect under the Internal Revenue  
            Service, as specified, as adjusted by the Patient Protection  
            and Affordable Care Act (ACA), as specified.

          6.Excludes specialized health plans or insurance policies from  
            3) through 5) unless the plan contract or policy offers or  
            provides an EHB.

          7.Limits, for an individual or group health care service plan  
            contract or health insurance policy issued, amended, or  
            renewed on or after January 1, 2015, that provides coverage  
            for prescribed, orally administered anticancer medications  
            used to kill or slow the growth of cancerous cells, the total  
            amount of copayments and coinsurance an enrollee or insured is  
            required to pay for orally administered anticancer medications  
            to $200 for an individual prescription of up to a 30-day  
            supply.

          8.Establishes Covered California as California's health benefit  
            exchange where individuals and small employers can purchase  
            standardized health insurance from selectively contracted  
            qualified health plans (QHPs) based on bronze, silver, gold  
            and platinum actuarial level categories.  
          
          This bill:
          1.Limits with respect to a non-grandfathered individual or group  
            health plan contract or insurance policy, the copayment,  
            coinsurance, or any other form of cost sharing for a covered  
            outpatient prescription drug for an individual prescription to  
            the following:

                  a.        For a non-time-limited course of treatment or  
                    a time-limited course of treatment of more than three  
                    months, 1/12 of the annual out-of-pocket limit for a  
                    supply of up to 30 days; and, 
                  b.        For a prescription drug that has a  
                    time-limited course of treatment of three months or  
                    less,  of the annual out-of-pocket limit applicable  
                    for the time-limited course of treatment.

          2.Requires for a high deductible health plan or insurance  
            policy, in 1) above, to only apply once an enrollee's  
            deductible has been satisfied for the plan year.




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          3.Exempts health plan contracts or insurance policies for  
            Medicare from the provisions of this bill.

          4.Applies the cost-sharing limits to outpatient prescription  
            drugs covered by the contract or policy that constitute EHBs.

          5.Prohibits this bill from being construed to affect the  
            reduction in cost sharing for enrollees or insureds eligible  
            for cost-sharing reductions under the ACA.

          6.Applies this bill to a specialized health plan contract or  
            insurance policy that offers or provides an EHB.  Exempts from  
            this bill specialized health plan contracts or insurance  
            policies that do not offer or provide an EHB.

          7.Applies this bill to an individual health plan contract or  
            insurance policy issued, amended, or renewed on or after  
            January 1, 2016, and to a group health plan contract or  
            insurance policy that is issued, amended, or renewed on or  
            after July 1, 2015.

          8.Defines "outpatient prescription drug" as a drug approved by  
            the federal Food and Drug Administration, and prescribed by a  
            licensed health care professional acting within his or her  
            scope of practice, that is self-administered by a patient,  
            administered by a licensed health care professional in an  
            outpatient setting, or administered in a clinical setting that  
            is not an inpatient setting.

          9.Defines plan year for the group market as defined in federal  
            regulations, as specified, and for the individual market as  
            the calendar year.

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee

          1.One-time costs to CDI for oversight and review of $50,000 and  
            ongoing potential enforcement costs of $70,000 annually  
            (Insurance Fund). 

          2.One-time costs to DMHC for review and regulations of $80,000,  
            and potential ongoing enforcement costs averaging $25,000 per  
            year (Managed Care Fund).





          AB 1917 | Page 4




          3.Unknown employer-funded premium costs in the private insurance  
            market and premium expenditures by employees and individuals  
            purchasing insurance, potentially in the millions to tens of  
            millions of dollars.  Some of these increased costs will be  
            offset by reduced out-of-pocket expenditures.

          4.To the extent this bill improves adherence to costly  
            medication, payers may experience some level of reduced  
            utilization and cost for other health care services.  Poor  
            adherence to prescription drugs is associated with increased  
            hospitalizations and emergency department visits.  The extent  
            of potential savings associated with improved adherence  
            attributable to this bill, however, is unknown. 

           PRIOR VOTES  :  
          Assembly Health:    13- 5
          Assembly Appropriations:12- 5
          Assembly Floor:     48-25
           
          COMMENTS  :  
           
          1.Author's statement.  According to the author, the annual  
            out-of-pocket limit established last year is intended to protect  
            Californians from financial ruin by placing hard caps on how much  
            money patients will have to spend out of their own pocket for  
            health care services. This bill takes that goal a step further but  
            limits it to prescription drugs.  Patients with cancer, HIV/AIDS,  
            hepatitis, multiple sclerosis, and other serious and chronic  
            conditions need high cost specialty drugs, which can cost  
            thousands of dollars.  These Californians can often reach their  
            out-of-pocket limit in the first month of the plan year with only  
            one prescription drug.  Many Californians would find it difficult  
            to spend $6,350, let alone in one month.  Too many patients are  
            forced to choose between paying for their life-saving drugs and  
            paying for housing, child care, or food.  In turn, many are  
            suffering, and even face death, from illnesses that are treatable.  
             AB 1917 reduces the prescription drug cost sharing for patients  
            by capping the amount an individual pays based on a percentage of  
            the out-of-pocket limit.  This protects Californians and makes it  
            easier for them to realistically afford and pay for their health  
            care thereby increasing patients' access and medication adherence  
            to life-saving drugs.  

          2.California Health Benefits Review Program (CHBRP) analysis.  AB  
            1996 (Thomson), Chapter 795, Statutes of 2002, requests the  
            University of California to assess legislation proposing a  




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            mandated benefit or service and prepare a written analysis with  
            relevant data on the medical, economic, and public health impacts  
            of proposed health plan and health insurance benefit mandate  
            legislation. CHBRP was created in response to AB 1996.  Below are  
            major findings of CHBRP's analysis.

               a.     Enrollees Covered:  CHBRP estimates that in 2015,  
                 11.7 million of 23.4 million Californians with state  
                 regulated health insurance would have coverage subject to  
                 this bill.  Enrollees eligible for cost-sharing  
                 reductions under the ACA have incomes between 100 percent  
                 and 250 percent of the federal poverty level and are  
                 enrolled in a silver metal-level QHP in Covered  
                 California.  Approximately, 730,000 in 2015 are estimated  
                 by CHBRP to have reduced cost sharing, including lower  
                 annual out-of- pocket maximums through Covered California
               b.     Impact on Expenditures:  In a revised analysis based  
                 only on the 1/12 cap, CHBRP indicates expenditures would  
                 increase in California by an estimated $43.3 million in  
                 the non-grandfathered group and individual market.   
                 Premium increases are estimated to range from an average  
                 of .02 percent for group plans to an average of .17  
                 percent for individual market policies.  Enrollee  
                 out-of-pocket expenses would be reduced by an estimated  
                 $7 million.  As for the amendment regarding time-limited  
                 prescriptions and not time-limited prescriptions, CHBRP  
                 is not able to quantitatively say by how much or what the  
                 magnitude, but the  limitation would likely result in  
                 additional reduction in expenditures.
               c.     Medical Effectiveness:  CHBRP states that overall  
                 there is strong evidence that persons who face higher  
                 cost sharing reduce use of both essential and  
                 non-essential services, and for prescription drugs, there  
                 is evidence that as cost sharing increases for  
                 prescription drugs, including specialty prescription  
                 drugs, usage decreases.
               d.     Benefit Coverage.  The mandate is expected to have  
                 the greatest impact on high cost and/or specialty drugs.   
                 According to CHBRP, the average cost sharing per  
                 outpatient prescription drug claim pre-mandate is  
                 $408.94, and post-mandate is $302.24.  This is lower than  
                 the cap of $529 because some people will hit their  
                 out-of-pocket maximum due to other additional expenses.   
                 CHBRP points out that there is no standard industry  
                 definition of specialty prescription drugs, but specialty  




          AB 1917 | Page 6




                 drugs are 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.  Examples of  
                 conditions that require treatment using specialty drugs  
                 include growth hormone disorders, rheumatoid arthritis,  
                 asthma, multiple sclerosis, hepatitis C, hemophilia,  
                 cancer and lupus.
               e.     Utilization.   According to CHBRP approximately  
                 25,582 enrollees have high cost/specialty prescription  
                 drug claims greater than the AB 1917 limit on cost  
                 sharing (1/12th).   The limit on cost sharing would  
                 increase utilization of high cost and/or specialty drugs  
                 by 1.35 percent and there would be an estimated 345 new  
                 users.
               f.     Public Health.  CHBRP projects no measurable public  
                 health impact due to the small percentage of enrollees  
                 (.24 percent) utilizing high cost and/or specialty  
                 prescription drugs with cost sharing that would be  
                 lowered.  However, 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.
               g.     Essential Health Benefits.  This bill would not  
                 exceed EHBs and would not require the state to defray the  
                 costs of this mandate for enrollees in QHPs.

          3.Covered California Standard Benefit Design.  For 2015, the  
            Covered California individual market silver plan the standard  
            prescription drug benefit and other benefits are shown in the  
            table below.  For prescription drug benefits the standards are  
            the same for the 70.30 percent actuarial value and the 69.90  
            percent actuarial value.  The difference in the actuarial  
            value is not attributable to the prescription drug benefits,  
            but instead to the design of other benefit cost sharing  
            designs.  For example, imaging subject to a 20 percent cost  
            share after the deductible in one standardized plan and a $250  
            copayment in the other.  

          
             -------------------------------------------- 
            |                  |Coinsurance| Copay Plan  |
            |                  |    Plan   |             |
            |------------------+-----------+-------------|
            |Actuarial Value   |   70.30   |    69.90    |




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            |                  |  percent  |   percent   |
            |------------------+-----------+-------------|
            |Deductibles       |           |             |
            |  Medical         |  $2,000   |   $2,000    |
            |  Brand Drugs     |   $250    |    $250     |
            |  Dental          |    $0     |     $0      |
            |Individual        |  $6,250   |   $6,250    |
            |out-of-pocket max |           |             |
            |                  |           |             |
            |------------------+-----------+-------------|
            |Generic           |    $15    |     $15     |
            |------------------+-----------+-------------|
            |Preferred Brand   |    $50    |     $50     |
            |copay after Drug  |           |             |
            |Deductible        |           |             |
            |------------------+-----------+-------------|
            |Non Preferred     |    $70    |     $70     |
            |Brand Drugs after |           |             |
            |Deductible        |           |             |
            |------------------+-----------+-------------|
            |Specialty Drugs   |20 percent | 20 percent  |
            |after Deductible  |           |             |
            |------------------+-----------+-------------|
            |Imaging           |20 percent |    $250     |
            |                  |subject to |             |
            |                  |deductible |             |
            |------------------+-----------+-------------|
            |Children's dental |           |             |
            |                  |20 percent |$25          |
            |  Amalgam Fill    |           |             |
             -------------------------------------------- 
            
            Additionally, the table shows that for both standardized  
            plans, a person with a high cost specialty drug that has costs  
            of $10,000 per month would have to first meet the deductible  
            of $250 and then pay 20 percent or $1,950 for that  
            prescription for a total of $2,200 for the first month and  
            $2,000 per month after that.  If the individual has other  
            medications or other medical needs the individual would  
            out-of-pocket liability up to the maximum of $6,250.  If the  
            person had no other cost sharing liability, he or she would  
            pay $2000 in months two and three for the specialty drug and  
            in month four only $50 because the out-of-pocket maximum would  
            have been reached.  The person would have no cost sharing for  
            that drug and any covered benefits for the rest of the year.   




          AB 1917 | Page 8




            Under this bill, a person with a $10,000 per month specialty  
            drug cost share would only pay $529 per month for 11 months  
            and $181 in the 12th month because the out-of-pocket maximum  
            would have been reached.   

          4.Specialty drugs.  According to a February 2014 issue brief  
            published by America's Health Insurance Plans (AHIP), 25  
            percent of U.S. spending on prescription drugs in 2012 was on  
            specialty drugs.  Specialty drugs are structurally complex and  
            often require special handling or delivery mechanisms and are  
            priced much higher than traditional drugs.  The treatment  
            regimen for some of the most expensive specialty drugs can  
            cost $750,000 per year.  Because of the comparatively high  
            cost of these drugs, the commercial trend for pharmaceutical  
            spending in 2012 was driven almost entirely by increases in  
            the unit cost of specialty drugs.  Spending on specialty drugs  
            has shown no signs of abating; similar double digit increases  
            are forecast for 2013-2015.  In 2013, 60 percent of the drugs  
            approved by the federal Food and Drug Administration are  
            expected to be specialty drugs.  While these drugs offer  
            tremendous promise when medically necessary, their high costs  
            and extended use has put a strain on the health system and  
            health plans, employers and other stakeholders are searching  
            for ways to restrain cost growth while maintaining access to  
            safe and effective drugs for patients.  According to the  
            brief, based on 2010 data the following conditions had the  
            following average cost per treatment member per year:   
            Inflammation Conditions - $14,455, Multiple Sclerosis -  
            $24,118, Cancer - $11,089, Pulmonary Hypertension - $32,570,  
            and Respiratory Conditions - $18,550.  
          
          5.Related legislation. SB 1176 (Steinberg), requires a health  
            plan or health insurer to track the accumulation of cost  
            sharing for covered EHBs and makes a health plan or insurer  
            responsible for notifying the enrollee or insured when the  
            maximum accrual limit has been reached and requires the plan  
            or insurer to reimburse the enrollee or insured if cost  
            sharing exceeds annual limits.  SB 1176 is set for hearing on  
            June 17, 2014 in Assembly Health Committee.
          
            AB 2418 (Bonilla), requires health plans and insurers to allow  
            enrollees to opt out of any mandatory mail order prescription  
            program, allows for the synchronization of prescription  
            refills, and permits early refill of topical ophthalmic  
            medications, effective January 1, 2016. AB 2418 is set for  
            hearing on June 25, 2014 in this Committee.




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          6.Prior legislation.  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  
            anticancer medications to $200 for an individual prescription  
            of up to a 30-day supply.  Governor Brown wrote in a message  
            approving AB 219 that this policy is not without the potential  
            for unintended consequences and that placing a price cap on a  
            specific class of drugs for a specific class of diseases might  
            not be a policy for the ages.  A sunset on the bill allows for  
            examination of intended and unintended consequences before  
            embracing the policy long term.

            SB 639 (Hernandez), Chapter 316, Statutes of 2013 places in  
            California law provisions of the ACA relating to 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. Applies health plan enrollee and insured  
            out-of-pocket limits to specialized products that offer EHBs.   
            Allows carriers in the small group market to establish an  
            index rate no more frequently than each calendar quarter.  

            AB 1000 (Perea), of 2011, would have required a health plan  
            contract or health insurance policy that provides coverage for  
            prescription drugs and cancer chemotherapy treatment to limit  
            enrollee out-of-pocket costs for prescribed, orally  
            administered anti-cancer medications.  AB 1000 was vetoed by  
            Governor Brown, stating that the bill doesn't distinguish  
            between health plans and insurers who make these drugs  
            available at a reasonable cost and those who do not.  
               
            SB 961 (Wright), of 2010, which was virtually identical to AB  
            1000, was vetoed by Governor Schwarzenegger, who stated in his  
            veto message that the bill would have added costs to  
            increasingly expensive health insurance premiums and it was  
            unnecessary in light of federal health reform.
               
          7.Support.  Health Access California writes that the emergence  
            of very high cost specialty drugs as well as drugs  
            administered on an outpatient basis, such as chemotherapy, has  
            led health plans and insurers to impose high copays and  
            coinsurance on these drugs.  Such high cost drugs are often on  
            a fourth tier of a drug formulary with coinsurance of 10  




          AB 1917 | Page 10




            percent or 20 percent so a patient may exhaust their annual  
            out-of-pocket limit with a single prescription in the first  
            month.  Asking someone to spend $6,000 for a single  
            prescription upfront is unrealistic.  This bill directly  
            benefits Californians by spreading the cost of prescription  
            drugs so that patient with expensive medications will not be  
            forced to pay high upfront costs.  Western Center on Law and  
            Poverty states that consumers may be able to work out payment  
            plans if they do not have money to pay for a medication, but  
            all too often the answer is that they simply cannot purchase  
            the medication.  The intent of this bill is to protect insured  
            Californians from financial ruin.  
          
          8.Opposition.  America's Health Insurance Plans writes that this  
            bill further confuses the benefit design for consumers and  
            makes it more difficult to provide affordable health plans  
                                                that consumers want to purchase.  In order to keep the  
            actuarial value in balance, health plans would need to make an  
            adjustment to some other type of cost sharing in the benefit  
            design to off-set the reduction if a separate cost-sharing  
            limit is established for prescription drugs.  Imposing  
            separate cost-sharing limits for prescriptions does nothing to  
            address the problem of increasing health care costs.   
            Opponents, such as the California Chamber of Commerce,  
            indicate this bill will increase the usage of the most costly  
            specialty medications, which already account for  25 percent  
            of all spending for prescription drugs.  The ACA and SB 639  
            help shield individuals and families from the ever rising cost  
            of health care, setting additional limits that encourage use  
            of costly prescription drugs at the expense of other health  
            care products and services, will dramatically increase health  
            care spending and will force individuals and employers to pay  
            higher premiums.
          
          9.Amendment.  The bill should be amended to clarify that the  
            out-of-pocket limit referenced in the bill is the limit for an  
            individual and not for the family.  
          
          
           SUPPORT AND OPPOSITION  :
          Support:  Health Access California (sponsor)
                    American Cancer Society Cancer Action Network
                    California Alliance for Retired Americans
                    California Healthcare Institute
                    California Teachers Association
                    CALPIRG




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                    Hemophilia Council of California
                    Los Angeles Gay & Lesbian Center
                    National Alliance on Mental Illness California
                    National Multiple Sclerosis Society
                    Project Inform
                    Western Center on Law and Poverty

          Oppose:   Aetna
                    America's Health Insurance Plans
                    Anthem Blue Cross
                    Association of California Life and Health Insurance  
                    Companies
                    California Chamber of Commerce
                    California Association of Health Plans
                    California Association of Health Underwriters
                    California Association of Joint Powers Authorities
                    California Manufacturers and Technology Association
                    Molina Healthcare of California
                    National Federation of Independent Business
                    Pharmaceutical Care Management Association




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