1 1 1 1 1 1 1 1 0 1 0 1 A: Removing Barriers to Over-the-Counter Contraception for Low-Income Women The American Public Health Association (APHA) has long endorsed universal access to reproductive health care, including contraception, as an important public health measure. 1 The APHA has supported over-the-counter (OTC) access to emergency contraception (EC), and in particular urged the U.S. Food and Drug Administration (FDA) to make emergency contraception available over the counter for patients of all ages, including those under 1 who are still required to obtain a prescription under the FDA's August 00 ruling, so as to improve overall ease of patients' access to this medication. A federal Court recently ordered the FDA to review its decision to place age restrictions and other restrictive conditions on the sale of EC. The FDA s decision to allow over-the-counter sale of EC in 00 resulted in increased access for many women. In 00, when EC was a prescription-only product, percent of pharmacies reported being unable to dispense Plan B within hours. Two years later, just percent did. However, coverage is still out of reach for many women who cannot afford to pay out-of-pocket for the high cost of obtaining OTC EC. The majority of public and private health insurance programs still require a prescription to obtain OTC contraception products, such as EC, if their plans and programs cover OTC methods at all. States have the option of covering OTC drugs in their state Medicaid programs, however, in a recent study, only 1- states reported that they cover condoms, spermicides or sponges in their family planning programs, and the majority require a prescription. Only nine states currently provide true over-the-counter access through their state Medicaid programs and allow women to obtain EC OTC without a prescription. The federal Medicaid program requires a prescription for family planning drugs and supplies that are normally sold over-the-counter, including male and female condoms, spermicides, sponges and other OTC contraceptives. The prescription requirement adds costly and unnecessary clinic and doctor visits, and creates barriers to OTC family planning drugs and supplies for Medicaid beneficiaries, resulting in unequal access to contraception and other prevention supplies and widening health disparities for low-income populations and communities of color. By definition, OTC access indicates that the FDA has deemed use of these products safe without the need for consultation with a health care provider; these prescription requirements are administrative and A-1
1 1 1 1 1 1 create barriers to rather than facilitating safe and effective use of contraception and prevention supplies. The public health consequences of lack of access to contraceptives are well-documented. Half of all pregnancies in the U.S. are unintended over million per year. 1. million women in the U.S. depend on publicly funded family planning services to support their decisions about when and whether to have a child. Sexually transmitted infections (STIs) continue to be a public health threat, and their prevalence reflects significant health disparities. For example, Chlamydia is the most common reportable infectious disease in the U.S. Risks to women of this infection include pelvic inflammatory disease, ectopic pregnancy, premature rupture of membranes and pre-term birth, and neonatal pneumonia. Each year,000 women become infertile due to Chlamydia. In 00, black adolescents age 1-1, followed by black women age 0-, had the highest rates of Chlamydia; Latinas experienced Chlamydia rates three times that of non-latina white women. The annual cost of STIs to the U.S. health care system is estimated to be $1. billion. 1 In addition, preventing unintended pregnancy and pregnancy planning play a critical role in reducing poor birth outcomes for women with chronic diseases. 1 Access to contraceptives is essential to improved maternal health and birth outcomes. 1 1 0 1 Medicaid and insurance coverage of OTC family planning drugs and supplies without a prescription will reduce unintended pregnancies and STIs. Implementing true over-the-counter access to emergency contraception, condoms including the new FDA-approved female condom, and other contraceptive drugs and supplies will reduce health care costs, and promote health and well-being and healthier pregnancies when and if women decide to become parents. 1 0 1 In addition to family planning drugs and supplies that are currently approved for OTC sale, there is growing interest to consider whether oral contraceptives (OCs) and possibly other hormonal methods might also be appropriate for a prescription-to-otc switch. 1,1 A growing body of evidence suggests that women could safely use OCs if they were available OTC and that contraceptive uptake might increase if this method were available directly in a pharmacy. 1,1 However, concerns about the financial impact on Medicaid beneficiaries, who might lose coverage for an OTC product, make some question the utility of an OTC switch. 1 It is critical that insurance A-
1 1 1 1 1 1 1 1 0 1 0 1 coverage policies not obstruct advances that otherwise might benefit the nation s public health. Recognizing the public health benefit of improved access to contraception, the American Public Health Association urges: 1. Congress and federal agencies to enact legislation and policies that will provide federal Medicaid coverage for all family planning drugs and supplies that are FDA-approved for sale over-thecounter, and not to require a prescription for such coverage.. Health insurers and managed care organizations to include in their insurance products coverage for all family planning drugs and supplies that are FDA-approved for sale over-the-counter, and not to require a prescription for such coverage.. State legislative bodies and agencies, in the absence of federal Medicaid funding, to provide state-funded Medicaid coverage for all family planning drugs and supplies that are FDA-approved for sale over-the-counter, and not to require a prescription for such coverage. Submitted by Susan Berke Fogel, JD On behalf of the Section on Population, Reproductive and Sexual Health Contact: fogel@healthlaw.org or 1.1. References: 1. American Public Health Association, APHA Policy Statement No. 00, Ensuring that Individuals are able to Obtain Contraceptives at Pharmacies. Washington D.C.: American Public Health Association. Nov., 00.. American Public Health Association, APHA Policy Statement No. 001: Support of Public Education about Emergency Contraception and Reduction or Elimination of Barriers to Access. Washington D.C.: American Public Health Association. Nov. 1, 00.. Tummino v. Torti, 0 F. Supp. d 1, -0 (E.D.N.Y. 00).. Gee RE, Shacter HE, Kaufman EJ, Long JA, Behind-the-counter status and availability of emergency contraception Am J Obstet Gynecol. 00 Nov;1():.e1-. Epub 00 Jun 1.. U.S.C. 1r-(k)().. Ranji U, Salganicoff A, State Medicaid Coverage of Family Planning Services. Washington D.C.: Kaiser Family Foundation. Nov. 00; accessed at A-
1 1 1 1 1 1 1 1 0 1 0 1 http://www.kff.org/womenshealth/upload/01.pdf.. National Institute for Reproductive Health, Expanding Public Health Insurance Coverage for EC on the State Level: Updated February 0. New York, New York: National Institute for Reproductive Health. Feb 0; National Health Law Program, Over the Counter or Out of Reach; A Report on Evolving State Medicaid Policies for Covering Emergency Contraception. Washington D.C.: National Health Law Program. June 00.. Guttmacher Institute, Facts on Publicly Funded Contraceptive Services in the United States. Washington D.C.: Guttmacher Institute. Feb. 00; accessed at http://www.guttmacher.org/pubs/fb_contraceptive_serv.html.. Centers for Disease Control and Prevention, Sexually Transmitted Diseases, Chlamydia: CDC Fact Sheet, accessed at http://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm.. Centers for Disease Control and Prevention, Pelvic Inflammatory Disease: CDC Fact Sheet. page last modified Apr., 00; accessed at http://www.cdc.gov/std/pid/stdfact-pid.htm.. Centers for Disease Control and Prevention, Sexually Transmitted Diseases in the United States, 00: National Surveillance data for Chlamydia, Gonorrhea and Syphilis. Nov 00:. 1. Centers for Disease Control and Prevention, Sexually Transmitted Diseases in the United States, 00: National Surveillance data for Chlamydia, Gonorrhea and Syphilis. Nov 00: 1. 1. Centers for Disease Control and Prevention. Recommendations to Improve Preconception Health and Health Care - United States: a report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR 00 April 1:1-. 1. New York State determined that eliminating the federal requirement for a prescription order prior to dispensing over-the-counter emergency contraception (and using state funds to pay for these drugs) would yield a conservative gross annual cost savings of $. million (with an estimated $1. million in savings each for the state and federal governments). The methodology was based on avoiding the cost of prenatal care, delivery, and associated delivery costs in New York State, by providing emergency contraception OTC instead. N.Y. Reg., Jan., 00:. 1. Trussell J, Stewart F, Potts M, Guest F, Ellertson C. Should oral contraceptives be available without prescription? Am J Public Health 1;():-. 1. Grossman D, Ellertson C, Abuabara K, Blanchard K, Rivas FT. Barriers to contraceptive use in product labeling and practice guidelines. Am J Public Health. 00;():1-. 1. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self- A-
screening for contraindications to combined oral contraceptive use. Obstet Gynecol 00;():-. 1. Landau SC, Tapias MP, McGhee BT. Birth control within reach: a national survey on women's attitudes toward and interest in pharmacy access to hormonal contraception. Contraception 00;():-0. 1. Grossman D. Should the contraceptive pill be available without prescription? Yes. BMJ. 00;:a0. doi:./bmj.a0. A-