BILL ANALYSIS Ó SB 999 Page 1 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 SB 999 Page 2 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 SB 999 Page 3 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. SB 999 Page 4 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. SB 999 Page 5 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 SB 999 Page 6 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 SB 999 Page 7 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 SB 999 Page 8 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 SB 999 Page 9 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 SB 999 Page 10 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 SB 999 Page 11 (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 SB 999 Page 12 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 SB 999 Page 13 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. SB 999 Page 14 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 SB 999 Page 15 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 SB 999 Page 16 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 SB 999 Page 17