BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     SB 999


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          Date of Hearing:  June 14, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          SB  
          999 (Pavley) - As Amended April 18, 2016


          SENATE VOTE:  29-6


          SUBJECT:  Health insurance:  contraceptives:  annual supply.


          SUMMARY:  Requires coverage for up to a 12-month supply of Food  
          and Drug Administration (FDA) approved, self-administered  
          hormonal contraceptives (contraceptives) and permits pharmacists  
          to dispense these contraceptives consistent with existing  
          protocols and upon a patient's request.  Specifically, this  
          bill:  


          1)Requires health care service plan (health plan) contracts and  
            health insurance policies, issued, amended, renewed, or  
            delivered on or after January 1, 2017, to provide coverage for  
            up to a 12-month supply of FDA-approved contraceptives when  
            dispensed at one time for an enrollee by a provider,  
            pharmacist, or at a location licensed or otherwise authorized  
            to dispense drugs or supplies.  


          2)Prohibits construing this bill to require contraceptive  
            coverage by an out-of-network provider, pharmacy, or location  
            licensed or otherwise authorized to dispense drugs or  








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            supplies, except as otherwise authorized by state or federal  
            law or by the health plan's policies regarding out-of-network  
            coverage.


          3)Prohibits construing this bill to require a provider to  
            prescribe, furnish, or dispense 12 months of contraceptives at  
            one time.  


          4)Provides that a pharmacist furnishing self-administered  
            hormonal contraction pursuant to the Board of Pharmacy (BOP)  
            protocols may dispense, at the patient's request, up to a  
            12-month supply at one time.  


          EXISTING LAW:  


          1)Establishes the Department of Managed Care (DMHC) to regulate  
            health plans under the Knox-Keene Health Care Service Plan Act  
            of 1975 and the Department of Insurance (CDI) to regulate  
            health insurers under the Insurance Code.
          2)Establishes the Medi-Cal program, which is administered by the  
            State Department of Health Care Services (DHCS), under which  
            qualified low-income persons receive health care benefits and,  
            in part, governed and funded by federal Medicaid program  
            provisions.  


          3)Establishes the BOP to regulate the practice of pharmacy,  
            including the licensure of pharmacists.


          4)Requires a health plan contract, or a group or individual  
            policy of disability insurance, except for a specialized  
            health plan contract or a specialized health insurance policy,  
            that is issued, amended, renewed, or delivered on or after  
            January 1, 2016, to provide coverage for all of the following  








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            services and contraceptive methods for women:



             a)   All FDA-approved contraceptive drugs, devices, and other  
               products for women, including all FDA-approved  
               contraceptive drugs, devices, and products available over  
               the counter, as prescribed by the enrollee's or insured's  
               provider;



             b)   Voluntary sterilization procedures;



             c)   Patient education and counseling on contraception; and,



             d)   Follow-up services related to the drugs, devices,  
               products, and procedures, including, but not limited to,  
               management of side effects, counseling for continued  
               adherence, and device insertion and removal.


          5)Prohibits a health plan or disability insurer from imposing a  
            deductible, coinsurance, copayment, or any other cost-sharing  
            requirement on the coverage provided pursuant to contraceptive  
            coverage, except in the case of a grandfathered health plan.   
            Prohibits cost sharing from being imposed on any Medi-Cal  
            beneficiary. 
          6)Permits a religious employer to request a health plan contract  
            or disability insurance policy without coverage for  
            FDA-approved contraceptive methods that are contrary to the  
            religious employer's religious tenets, and requires a health  
            plan contract or disability insurance policy to be provided  
            without coverage for contraceptive methods, if requested.









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          7)Establishes as California's essential health benefits (EHBs)  
            as the Kaiser Small Group HMO plan, along with the following  
            10 federally mandated benefits under the Patient Protection  
            and Affordable Care Act (ACA), as well as other existing state  
            mandated benefits:


             a)   Ambulatory patient services;


             b)   Emergency services;


             c)   Hospitalization;


             d)   Maternity and newborn care;


             e)   Mental health and substance use disorder services,  
               including behavioral health treatment;


             f)   Prescription drugs;


             g)   Rehabilitative and habilitative services and devices;


             h)   Laboratory services;


             i)   Preventive and wellness services and chronic disease  
               management; and,


             j)   Pediatric services, including oral and vision care.









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          8)Permits a pharmacist to dispense no more than a 90-day supply  
            of a dangerous drug other than a controlled substance pursuant  
            to a valid prescription that specifies an initial quantity of  
            less than a 90-day supply followed by periodic refills of that  
            amount, if specified requirements are satisfied, such as the  
            patient has completed an initial 30-day supply of the  
            dangerous drug.  Prohibits a pharmacist from dispensing a  
            greater supply of a dangerous drug if the prescriber  
            personally indicates, either orally or in his or her own  
            handwriting, "No change to quantity," or words of similar  
            meaning.
          9)Permits a pharmacist to furnish self-administered hormonal  
            contraceptives in accordance with standardized procedures or  
            protocols developed and approved by both the BOP and the  
            Medical Board of California in consultation with the American  
            Congress of Obstetricians and Gynecologists (ACOG), the  
            California Pharmacists Association, and other appropriate  
            entities. 


          10)   Requires the standardized procedure or protocol in 9)  
            above to require that the patient use a self-screening tool  
            that will identify patient risk factors for use of  
            self-administered hormonal contraceptives, based on the  
            current United States Medical Eligibility Criteria for  
            Contraceptive Use developed by the federal Centers for Disease  
            Control and Prevention (CDC), and that the pharmacist refer  
            the patient to the patient's primary care provider or, if the  
            patient does not have a primary care provider, to nearby  
            clinics, upon furnishing a self-administered hormonal  
            contraceptive, or if it is determined that use of a  
            self-administered hormonal contraceptive is not recommended.


          11)   Requires the pharmacist to provide the patient a  
            standardized fact sheet that includes, but is not limited to,  
            the indications and contraindications for use of the drug, the  
            appropriate method for using the drug, the need for medical  








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            follow-up, and other appropriate information, developed, as  
            specified.  


          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee:

          1)Minor costs to review information from health insurers by the  
            CDI (Insurance Fund).



          2)No significant costs are anticipated to review health plan  
            information by the DMHC (Managed Care Fund).

          3)No significant costs or savings are projected for the Medi-Cal  
            program (General Fund (GF) and federal funds).  According to  
            an analysis of the bill by the California Health Benefits  
            Review Program (CHBRP), utilization of hormonal contraceptives  
            by Medi-Cal enrollees is not expected to increase  
            significantly.  This is because Medi-Cal already covers up to  
            a 12-month supply of oral contraceptives and utilization of  
            the other covered forms of contraception is very low.   
            Therefore, there is no significant increase in utilization  
            anticipated nor is there an anticipated reduction in health  
            care services related to unintended pregnancy. 



          4)Annual premium savings to the California Public Employees'  
            Retirement System of about $2 million per year, due to reduced  
            health care costs associated with unintended pregnancies (GF,  
            special funds, local funds).  About half of those savings  
            would accrue to the GF and special funds and half would accrue  
            to local governments.



          5)No state costs to subsidize coverage through Covered  








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            California are anticipated.  Under federal law, the costs of  
            any state-imposed benefit mandate that exceeds the EHBs  
            included in the state's benchmark plan is a state  
            responsibility.  In other words, if the state imposes a new  
            benefit mandate on health plans or health insurers that sell  
            coverage through Covered California, the state is obligated to  
            pay for the cost to subsidize that benefit mandate for  
            enrollees receiving federal subsidies.  Because the bill does  
            not impose a new benefit mandate, but only changes the terms  
            of an existing mandate to cover contraceptives, this bill does  
            not expand the state's EHBs.



          COMMENTS:

          1)PURPOSE OF THIS BILL.  According to the author, California has  
            required insurance coverage for FDA-approved contraception  
            since 1998, but many hurdles remain.  Under current law,  
            health insurance companies and plans must limit coverage of  
            birth control to a one or three month supply.  This practice  
            can lead to unwanted gaps in birth control use and an  
            increased incidence of unintended pregnancies.  The author  
            cites a University of California (UC) San Francisco study that  
            found that women who received a full year's worth of birth  
            control pills at one time were 30% less likely to have an  
            unintended pregnancy than women who received a one or three  
            month supply.  The author states that there is growing  
            momentum nationwide to provide annual dispensing.  For  
            example, in 2013, the CDC recommended that women be provided  
            with a year's supply of self-administered hormonal  
            contraceptives.  Also, in January 2015, ACOG issued guidelines  
            that recommended that payment and practice policies support  
            annual dispensing of contraceptives.  


            Additionally, the author notes that the language in this bill  
            requires health plans to cover up to a 12-month supply of  
            contraception and what is ultimately dispensed is the product  








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            of a conversation between the patient and the provider.  This  
            bill mandates that insurers cover instances when providers  
            conclude that dispensing 12 months at one time is in the best  
            interests of the patient.  Finally, the author notes other  
            states enacting similar laws, including Oregon, and cites to  
            the Oregon Health Plan and the Oregon Contraception Care  
            Program which found that it was rare for annual dispensing to  
            result in an oversupply of contraception.  


          2)BACKGROUND.  


             a)   CHBRP analysis.  AB 1996 (Thomson), Chapter 795,  
               Statutes of 2002, requests UC to assess legislation  
               proposing a 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.  SB 125 (Hernandez),  
               Chapter 9, Statutes of 2015, added an impact assessment on  
               EHBs, and legislation that impacts health insurance benefit  
               designs, cost sharing, premiums, and other health insurance  
               topics.  CHBRP states in its analysis of this bill the  
               following:


               i)     Enrollees covered.  CHBRP estimates that in 2016,  
                 25.2 million Californians have state-regulated coverage  
                 that would be subject to this bill. 


               ii)    Impact on expenditures.  CHBRP estimates that total  
                 net annual expenditures would decrease by $42.8 million  
                 or 0.03% for enrollees with DMHC-regulated plans and  
                 CDI-regulated policies.  This represents the anticipated  
                 savings in 2017 due to the avoidance of unintended  
                 pregnancies (leading to reduced delivery, miscarriage,  
                 and abortion costs) and the reduced number of office  








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                 visits in the first year postmandate.  The decrease in  
                 total expenditures is due to a $24 million decrease in  
                 total health insurance premiums paid by employers and  
                 enrollees, along with a decrease in enrollee  
                 out-of-pocket expenditures ($18.7 million), for an  
                 overall net decrease of $42.8 million. 


               iii)   EHBs.  This bill does not constitute a new benefit  
                 but rather, alters the terms and conditions (i.e., supply  
                 dispensed) of an existing benefit (coverage for  
                 self-administered hormonal contraceptives).  This bill  
                 does not exceed the EHBs. 


               iv)    Medical effectiveness.  There is a preponderance of  
                 evidence to indicate that dispensing oral contraceptives  
                 in larger quantities leads to a reduction in unintended  
                 pregnancy and related outcomes.  However, fewer studies  
                 examine the effect of the amount of dispensed supply of  
                 self-administered hormonal contraceptives, the primary  
                 impact of this bill.  There is a preponderance of  
                 evidence from studies with moderate research designs that  
                 conclude that dispensing oral contraceptives in larger  
                 quantities leads to a reduction in unintended pregnancy  
                 and related outcomes.  There was no known literature on  
                 the impact of dispensing patterns for vaginal ring and  
                 contraceptive patch.  Two studies were conducted  
                 examining data on women receiving oral contraceptive  
                 pills through the California Family PACT (Planning,  
                 Access, Care and Treatment) Program to compare pregnancy  
                 rates between women given a 12-month supply to those  
                 given a one or three month supply (Foster et al., 2011;  
                 Foster et al., 2006b).  The results indicated that women  
                 who were given a 12-month supply had reduced rates of  
                 unintended pregnancy (1.2% of women who received a  
                 12-month supply and 3.3% of women who received a three  
                 month supply) (Foster et al., 2011).  There was an  
                 associated 30% decrease in the odds of having an  








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                 unintended pregnancy, as well as a 46% decrease in the  
                 odds of an abortion when dispensing a 12-month supply  
                 compared to dispensing 1- or 3 month supplies (Foster et  
                 al., 2011).


               i)     Benefit coverage.  CHBRP estimates that coverage for  
                 an annual supply of self-administered hormonal  
                 contraceptives (including oral contraceptive pill, patch,  
                 and ring) would increase from 0% to 100% of enrollees of  
                 DMHC-regulated plans and CDI-regulated policies. 


               ii)    Utilization.  Postmandate, CHBRP estimates that the  
                 number of active self-administered hormonal contraceptive  
                 prescriptions will remain the same, but more women will  
                 receive a 12-month supply at once and office visits are  
                 expected to decrease. 


               iii)   Public Health.  As a result of SB 999, CHBRP  
                 estimates a decrease in unintended pregnancies of 15,000  
                 (which includes 6,000 fewer live births, 2,000 fewer  
                 miscarriages, and 7,000 fewer abortions).  Obtaining a  
                 12-month supply of self-administered hormonal  
                 contraceptives at one time reduces the potential for  
                 delays in refills between cycles.  Consistent, continuous  
                 contraceptive use helps to prevent any extension of the  
                 usual hormone-free interval; extension of this interval  
                 results in an increased possibility of unintended  
                 pregnancy.  CHBRP estimates that among the 744,000  
                 enrollees using self-administered hormonal  
                 contraceptives, 280,000 enrollees will shift to using a  
                 12-month prescription postmandate (resulting in 285,000  
                 total enrollees using a 12-month supply).  Among the  
                 285,000 enrollees using a 12-month prescription for  
                 self-administered hormonal contraceptives, CHBRP  
                 estimates that this bill will result in 15,000 averted  
                 unintended pregnancies.  Based on estimates by Kost  








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                 (2015) that 45% of unintended pregnancies in California  
                 end in abortion and 13% result in miscarriage, CHBRP  
                 estimates that 7,000 abortions and 2,000 miscarriages  
                 would be averted due to decreases in unintended  
                 pregnancies resulting from SB 999.


               iv)    Long-term impacts.  CHBRP projects that SB 999 would  
                 result in a decrease in the rate of unintended  
                 pregnancies and abortions over the long term, resulting  
                 in a corresponding decrease in the risk of maternal  
                 mortality, adverse child health outcomes, behavioral  
                 problems in children, and negative psychological outcomes  
                 associated with unintended pregnancies for both mothers  
                 and children.  Avoiding unintended pregnancies also helps  
                 women to delay childbearing and pursue additional  
                 education, spend additional time in their careers, and  
                 have increased earning power over the long term.


             a)   California Family Planning Program.  Family PACT is a  
               reproductive health program for clinical family planning  
               services.  Family PACT provides comprehensive family  
               planning services to women and men including all  
               FDA-approved forms of contraception, emergency  
               contraception, pregnancy testing with counseling,  
               preconception counseling, male and female sterilization,  
               limited infertility services, sexually transmitted  
               infection testing and treatment, cancer screening, and HIV  
               screening. Individual client reproductive health education  
               and counseling is an ongoing component of all services.  
               Family PACT clients are female and male residents of  
               California with a family income at or below 200% of the  
               federal poverty level with no other source of family  
               planning coverage. Clients are individuals with a medical  
               necessity for family planning services who do not have  
               Medi-Cal and do not have access to health insurance.  
               Medi-Cal clients with an unmet share of cost may also be  
               eligible. Eligibility determination and enrollment are  








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               conducted at the provider's office with point of service  
               activation of a client membership card.

             b)   Medi-Cal requirements.  According to a recently revised  
               All Plan Letter (APL) issued by DHCS, effective May 1,  
               2016, Medi-Cal managed care plans (MCPs) must pay for up to  
               13 cycles of oral contraceptives, up to 12 patches in a 90  
               day period, and up to four vaginal rings in a 90 day period  
               if such quantity is dispensed in an onsite clinic and  
               billed by a qualified family planning provider, including  
               out-of-plan providers.  A qualified provider is a provider  
               who is licensed to furnish family planning services within  
               their scope of practice, is an enrolled Medi-Cal provider,  
               and is willing to furnish family planning services to an  
               enrollee, as specified in regulation.  A physician,  
               physician assistant (under the supervision of a physician),  
               certified nurse midwife, and nurse practitioner are  
               authorized to dispense medications.  Pursuant to current  
               state law, if these contraceptives are dispensed by a  
               registered nurse (RN), the RN must have completed required  
               training, and the contraceptives must be billed with  
               Evaluation and Management procedure codes, as specified.

             The APL also states that under federal law, a primary care  
               case management system, a health maintenance organization,  
               or a similar entity shall not restrict the choice of the  
               qualified person from whom the individual may receive such  
               services under 1396d(a)(4)(C) of Title 42.  Therefore MCP  
               beneficiaries must be allowed freedom of choice of family  
               planning providers, and may receive such services from any  
               qualified family planning provider, including out-of-plan  
               providers, without prior authorization.

             c)   Other states.  Currently, only Oregon and the District  
               of Columbia have laws in effect that are similar to this  
               bill.  In 2015, Oregon became the first state in the  
               country to require that private insurers cover a 12-month  
               supply of contraceptives, including oral contraceptives,  
               the patch, and the ring dispensed at one time.  Following  








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               Oregon, the District of Columbia passed similar  
               legislation.  At the time of CHBRP's publication of its  
               analysis, several other states have considered such  
               legislation, including Alaska, New York, Rhode Island,  
               Washington, and Wisconsin.  Additionally, some state  
                   Medicaid programs and state family planning programs for  
               low-income residents already require a 12-month supply of  
               contraceptives to be dispensed at one time, including the  
               Oregon Contraceptive Care program. 





          3)SUPPORT.  Planned Parenthood Affiliates of California (PPAC)  
            states that consistency is essential for birth control to be  
            effective.  Additionally, for many women, particularly those  
            who live in low income rural areas, receiving only a short  
            supply of contraception can impede their ability to use birth  
            control on a consistent basis.  PPAC states that studies show  
            that dispensing a 12-month supply of birth control at one time  
            reduces a woman's odds of having an unintended pregnancy by  
            30%.


          4)OPPOSE UNLESS AMENDED.  The Association of California Life and  
            Health Insurance Companies (ACLHIC) and California Association  
            of Health Plans (CAHP) are concerned with the potential for  
            pharmaceutical waste, and are therefore requesting this bill  
            be amended to allow an insurer to request that a patient be  
            stabilized on the medication prior to the 12-month supply  
            being filled.  Additionally, ACLHIC and CAHP are requesting  
            that the implementation date be extended to January 1, 2018,  
            to allow health plans and insurers the necessary time to  
            integrate this new process into their systems and update their  
            policies to reflect the change in their products.  


          5)OPPOSITION.  The California Right to Life Committee, Inc.  








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            states that they oppose any measure that expands access to  
            abortifacients (drugs causing abortions).  


          6)DOUBLE-REFFERAL.  This bill was heard in the Senate Business,  
            Professions and Economic Development Committee on April 4,  
            2016 and was approved with a vote of 7-2.  This bill will also  
            be heard in the Assembly Business and Professions Committee.  


          7)RELATED LEGISLATION.  AB 1954 (Burke) creates the Direct  
            Access to Reproductive Health Care Act which prohibits health  
            plans or health insurance policies from requiring an enrollee  
            or insured to receive a referral before receiving coverage of  
            services for reproductive or sexual health care.  AB 1954 is  
            currently pending in the Senate.


          8)PREVIOUS LEGISLATION.  


             a)   SB 1053 (Mitchell), Chapter 576, Statutes of 2014,  
               requires a health plan contract or health insurance policy  
               issued, amended, or renewed on or after January 1, 2016, to  
               provide coverage for women for all prescribed and  
               FDA-approved female contraceptive drugs, devices, and  
               products, as well as voluntary sterilization procedures,  
               contraceptive education and counseling, and related  
               follow-up services.  Prohibits a nongrandfathered plan  
               contract or health insurance policy from imposing any  
               cost-sharing requirements or other restrictions or delays  
               with respect to this coverage, as specified.  


             b)   SB 493 (Hernandez), Chapter, 469, Statutes of 2013,  
               authorizes advanced practice pharmacists to perform other  
               functions, including, among other things, furnishing  
               self-administered hormonal contraceptives, nicotine  
               replacement products, and prescription medications not  








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               requiring a diagnosis that are recommended for  
               international travelers, as specified.


          REGISTERED SUPPORT / OPPOSITION:




          Support


          California Family Health Council (co-sponsor)
          NARAL Pro-Choice California (co- sponsor)
          Planned Parenthood Affiliates of California (co-sponsor)
          Alameda County Board of Supervisors
          American Civil Liberties Union of California
          American Congress of Obstetricians and Gynecologists, District  
          IX California
          American Medical Women's Association
          Asian Law Alliance
          Bayer Corporation
          Black Women for Wellness
          California Academy of Family Physicians
          California Academy of Physician Assistants
          California Medical Association
          California Pan-Ethnic Health Network 
          California Primary Care Association
          California Religious Coalition for Reproductive Choice
          California Women's Law Center
          Citizens for Choice
          Community Action Fund of Planned Parenthood of Orange and San  
          Bernardino Counties
          Community Clinic Association of Los Angeles County
          El Proyecto del Barrio, Inc.
          Forward Together
          Having Our Say Coalition
          Health Access California 
          Jewish Family Service of Los Angeles 








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          Kaiser Permanente
          Local Health Plans of California
          March of Dimes Foundation in California
          National Association of Social Workers, California Chapter
          Northeast Valley Health Corporation
          Physicians for Reproductive Health
          Planned Parenthood Action Fund of Santa Barbara, Bentura, & San  
          Luis Obispo Counties
          Planned Parenthood Action Fund of the Pacific Southwest 
          Planned Parenthood Advocacy Project Los Angeles County 
          Planned Parenthood Advocates Pasadena and San Gabriel Valley
          Planned Parenthood Affiliates of California
          Planned Parenthood Mar Monte
          Planned Parenthood Northern California Action Fund
          Secular Coalition for California
          


          Opposition


          America's Health Insurance Plans 
          Association of California Life and Health Insurance Companies
          California Association of Health Plans
          California Catholic Conference, Inc.
          California Right to Life Committee 
          




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














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