BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: SB 999 Hearing Date: April 4, 2016 ----------------------------------------------------------------- |Author: |Pavley | |----------+------------------------------------------------------| |Version: |March 29, 2016 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Huchel | |: | | ----------------------------------------------------------------- Subject: Health insurance: contraceptives: annual supply SUMMARY: Authorizes a pharmacist to dispense a 12-month supply of United States Food and Drug Administration (FDA)-approved, self-administered hormonal contraceptives (SAHC) and requires insurance to cover the cost. Existing law: 1) Establishes the Board of Pharmacy (BOP) to administer the Pharmacy Law. (Business and Professions Code (BPC) Sections 4000 et seq.) 2) Authorizes a pharmacist to dispense 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 under certain circumstances. Prohibits a pharmacist from dispensing a greater supply if the prescriber indicates otherwise. (BPC § 4064.5) 3) Authorizes a pharmacist to furnish SAHC in accordance with standardized procedures or protocols. (BPC § 4052.3) This bill: 1) Makes findings related to the benefits of providing a 12-month supply of FDA-approved SAHC. SB 999 (Pavley) Page 2 of ? 2) Provides an exception to the prohibition on pharmacists dispensing no more than a 90-day supply of a dangerous drug for FDA-approved SAHC. 3) Requires that a prescription for FDA-approved SAHC be dispensed as provided on the prescription, including, but not limited to, a prescription for a 12-month supply. 4) Authorizes a pharmacist furnishing FDA-approved SAHC pursuant to a protocol to dispense, at the patient's request, up to a 12-month supply at one time. 5) Requires every health care service plan contract and every group or individual policy of disability insurance, except for a specialized health insurance policy, that is issued, amended, renewed, or delivered on or after January 1, 2017, to cover a 12-month supply of FDA-approved SAHC dispensed by a prescriber or pharmacy at one time to an enrollee. 6) States that if a 12-month supply of FDA-approved SAHC is dispensed onsite at a location licensed or otherwise authorized to dispense drugs or supplies, the health care service plan or insurer shall cover the 12-month supply. 7) States that no reimbursement is required by this bill pursuant to the California Constitution. FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by Legislative Counsel. COMMENTS: 1.Purpose. This bill is sponsored by Planned Parenthood Affiliates of California, California Family Health Council, and NARAL Pro-Choice California. According to the Author, "This bill seeks to address the lack of consistent access to prescription contraception in California. California has required insurance coverage for prescription medications since 1998, but many hurdles to providing consistent coverage remain. "Specifically, this bill addresses current barriers to SB 999 (Pavley) Page 3 of ? obtaining consistent, uninterrupted contraception. Under current law, health insurance companies and plans must limit their 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. Inadequate supplies of birth control are particularly problematic for many women who have unpredictable work hours, difficulty accessing transportation, or other barriers preventing them from getting to a pharmacy or clinic." 2.Background. Pharmacies are constrained by state law from providing more than a three-month supply of SAHC pursuant to a prescription. However, certain clinics that dispense SAHC through a Medi-Cal program, Family Planning, Access, Care and Treatment (PACT), may provide up to a year's supply. This provided an ideal environment to study the effects of an increase in SAHC supply on unintended pregnancies. The results were published in a 2011 edition of Obstetrics and Gynecology, the medical journal of the American College of Obstetricians and Gynecologists (ACOG). In the "Number of Oral Contraceptive Pill Packages Dispensed and Subsequent Unintended Pregnancies," researchers found that women who received a full year's worth of pills at one time were 30 percent less likely to have an unintended pregnancy than women who received either a one-month or three-month supply of pills. There was no definitive reason for this reduction in unintended pregnancies, but analysts believe that several factors contributed including: (1) having a larger supply on hand reduced the opportunity for lapse in dosages due to the need to restock, and (2) each visit to get more SAHC was an opportunity to reconsider taking it -- an extensive supply reinforced the idea that this method of birth control was effective and safe. Although a minority of women have complications from SAHCs, such as blood clots, AGOG determined in a 2012 report that the risk of getting a blood clot from a SAHC is less than it is for a clot during or immediately following pregnancy. If these results were to be borne across the state, significant individual health benefits and financial savings could be realized by preventing unintended pregnancies. SB 999 (Pavley) Page 4 of ? 3.Endorsements and Other States' Practices. a) The United States Centers for Disease Control (CDC) recommended that women be provided with a year's supply of SAHC in its publication, "U.S. Selected Practice Recommendations for Contraceptive Use, 2013: Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition." b) ACOG recommended that payment and practice policies support providing individuals with a 3- to 13-month supply of oral contraceptives in January 2015. c) On February 5, 2015, the California Department of Health Care Services began requiring all Medi-Cal managed care and their delegates to pay for 12 month dispensing for SAHC. d) Oregon and the District of Columbia passed laws in 2015 authorizing a 12 month supply of SAHC. 4.Arguments in Support. Planned Parenthood Affiliates of California write, "On behalf of Planned Parenthood Affiliates of California and the more than 115 health centers throughout the state, we are pleased to support SB 999 (Pavley). This bill would require all health care service plans and health insurers to cover up to 12-months of FDA-approved self-administered hormonal contraceptives when dispensed at one time. "This bill will improve access to contraceptives by allowing a woman to receive a year's supply of prescribed hormonal contraceptives rather than requiring her to return every 30 to 90 days to obtain a refill. For birth control to be effective, consistency is essential. For many women, particularly those who live in low income rural areas, receiving only short supply of contraception can impede their ability to use birth control on a consistent basis. Additionally, 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%. "This bill makes dispensing a 12-month supply of birth control a best practice in the commercial and Medi-Cal managed care settings and for these reasons, we strongly SB 999 (Pavley) Page 5 of ? support SB 999 (Pavley) and urge your AYE vote when it is heard in the Senate Business, Professions and Economic Development Committee." 5.Arguments in Opposition. The California Catholic Conference, Inc. writes, "SB 999 would reduce the standard of care for women seeking help and information regarding the variety of proven contraception methods available. If the author's rationale for this bill is to reduce the number of pregnancies in our state, then women ought to also be made aware of other safe and effective pregnancy-prevention methods, such as natural family planning, which is a medically endorsed tool for couples to making parenting decisions, especially those struggling with contraceptive-related infertility issues. Natural techniques respect the dignity of the human person through emphasizing shared responsibility, intimate communication, and mutual respect." Association of California Life and Health Insurance Companies writes, "While we appreciate the author's intent and are supportive of medication adherence, we do not believe that dispensing a full year of birth control at one time is a practical solution. The consequences of this measure could very well result in the duplication of coverage by different insurers, and an increase in wasted medication. "Additionally, for similar reasons as stated above, we are concerned that the bill does not specify that for new medication, an insurer may require a patient to try an initial 30 or 90 day supply prior to filling the 12 month supply. Without incorporating a mandatory trial period, it is inevitable that we will see a rise in unused medication as some women will choose to switch medications due to unexpected side effects, or even a change in the desire or need to use contraceptives. In all of these instances the 12 month supply would likely end up either partially used or altogether unused, which inevitably would increase the amount of pharmaceutical waste." 6.Related Legislation. SB 1193 (Hill) extends the sunset date on the BOP until 2021. ( Status : This bill is pending in Senate Business, Professions and Economic Development SB 999 (Pavley) Page 6 of ? Committee.) 7.Prior Related Legislation. SB 493 (Hernandez, Chapter 469, Statutes of 2013) expanded the scope of practice of a pharmacist to recognize an "advanced practice pharmacist"; permited pharmacists to furnish certain hormonal contraceptives, nicotine replacement products, and prescription medications for travel, as specified; and authorized pharmacists to independently initiate and administer certain vaccines and treatments for severe allergic reactions. NOTE : Double-referral to the Senate Committee on Health which will address the health insurance implications of this measure. SUPPORT AND OPPOSITION: Support of bill as introduced 2/10/16: Planned Parenthood Affiliates of California (Sponsor) California Family Health Council (Sponsor) NARAL Pro-Choice California (Sponsor) American Civil Liberties Union of California American College of Obstetricians and Gynecologists American Medical Women's Association Asian Law Alliance Bayer California Academy of PAs California Medical Association 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 Health Access California National Association of Social Workers, California Chapter Physicians for Reproductive Health Planned Parenthood Action Fund of Santa Barbara, Ventura, and San Luis Obispo Planned Parenthood Advocates Pasadena and San Gabriel Valley SB 999 (Pavley) Page 7 of ? Planned Parenthood Mar Monte Planned Parenthood Northern California Action Fund Opposition to bill as introduced 2/10/16: Association of California Life and Health Insurance Companies California Association of Health Plans California Catholic Conference, Inc. California Right to Life Committee America's Health Insurance Plans -- END --