The enactment of the Patient Protection and Affordable Care Act (PPACA)1 expands access to Medicaid services, including family planning, to millions of women. According to the Kaiser Family Foundation, there are currently 17 million uninsured women who may have access to coverage when the PPACA is fully implemented.2 A total of 6 to 7 million women will be new enrollees in Medicaid, with many more having access to family planning services through the new Medicaid State Option to expand eligibility for family planning services3 and through the health insurance exchanges. In addition, PPACA requires that certain preventive services be mandatory benefits provided without copayment in insurance products sold through the exchanges. On the basis of the recommendations of the Institute of Medicine, the Department of Health and Human Services (HHS) issued guidelines for women’s preventive services that all new private insurance plans must cover without cost-sharing beginning in August 2012.4 These covered preventive services include all Food and Drug Administration (FDA)–approved contraceptive methods. Also included are sterilization procedures and patient education and counseling for all women with reproductive capacity.4
Approximately 10% of women of reproductive age report using contraceptive methods that are available over the counter, including condoms and spermicides.5 In 2006, FDA approved the sale of emergency contraception over the counter (OTC). In addition, FDA has recently approved the sale of new contraceptive products, including the FC2 female condom and generic emergency contraception products, all of which are expanding the options of OTC contraceptives.6 While OTC status may make these methods more accessible to some users, public and private insurances often limit coverage of OTC drugs and devices, thus negating any potential improvement in access.
The American Public Health Association (APHA) has long endorsed universal access to reproductive health care, including contraception, as an important public health measure. In 2003, Policy Statement 200315, “Support of Public Education About Emergency Contraception and Reduction or Elimination of Barriers to Access,” expressed APHA support for OTC access to emergency contraception for all women, and in particular urged FDA “to make emergency contraception available over the counter for patients of all ages, including those under 18 who are still required to obtain a prescription under the FDA’s August 2006 ruling, so as to improve overall ease of patients’ access to this medication.”7 With Policy Statement 200611, “Ensuring That Individuals Are Able to Obtain Contraceptives at Pharmacies,” APHA adopted strong policy language aimed at ensuring that women and adolescents can obtain emergency contraception at pharmacies when pharmacists refuse to fill prescriptions.8 Neither of these policies focuses specifically on issues of financial access and insurance coverage of OTC contraceptives.
FDA’s decision to allow OTC sale of emergency contraception resulted in increased access for many women. It should be noted that while these products are approved for OTC sale without a prescription, there are some restrictions, including that they can only be sold in pharmacies and must be kept behind the counter. For the purpose of this policy, they are considered OTC products. In 2005, when emergency contraception was a prescription-only product, 23% of pharmacies reported being unable to dispense Plan B within 24 hours. Two years later, just 8% did.9 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 emergency contraception. The majority of public and private health insurance programs still require a prescription to obtain OTC contraception products, such as emergency contraception, if their plans and programs cover OTC methods at all. States have the option of covering OTC drugs in their state Medicaid programs10; however, in a recent study, only 31 or 32 states reported that they cover condoms, spermicides, or sponges in their family planning programs, and most require a prescription.11 Only 9 states currently provide true OTC access through their state Medicaid programs and allow women to obtain OTC emergency contraception without a prescription.12,13 These states (Hawaii, Illinois, Maryland, New Jersey, New Mexico, New York, Oklahoma, Oregon, and Washington) allow pharmacists to bill the state Medicaid program, but the claims are paid with state-only funds. In most states, the state Medicaid agency has agreed to include OTC coverage for emergency contraception in response to advocacy from reproductive health advocates and medical professionals. In Illinois and Oklahoma, for example, the state Medicaid agencies covered condoms without a prescription before emergency contraception was approved by FDA. In 2006, emergency contraception was added under the existing state policies. In New Mexico, at the request of the state legislature, the New Mexico Health Policy Commission conducted a study on access to emergency contraception, which recommended using state Medicaid funds to cover OTC emergency contraception.14 After New York approved Medicaid coverage of OTC emergency contraception without a prescription in 2007, 73% of Medicaid claims for emergency contraception were for the OTC product, and it is estimated that 300 to 500 unintended pregnancies were prevented.15
The federal Medicaid program requires coverage of “family planning services and supplies.” However, Medicaid rules require that the enrollee obtain a prescription for any drug or supply that is normally sold over the counter, including family planning drugs and supplies such as male and female condoms, spermicides, sponges, emergency contraception, and other OTC contraceptives.10 While the PPACA allows states to expand their family planning programs through a Medicaid state plan amendment, it did not change the prescription requirement. 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 FDA has deemed use of these products safe without the need for consultation with a health care provider; these prescription requirements are administrative and create barriers to, rather than facilitating safe and effective use of, contraception and prevention supplies. While the Medicaid prescription requirement is a barrier to access to a range of medically necessary drugs and supplies such as eye drops or iron supplements, it is particularly burdensome for anyone trying to prevent pregnancy and sexually transmitted infections (STIs). For example, emergency contraception is most effective when used as soon as possible after unprotected sex. The prescription requirement, in particular over weekends, can cause a significant delay in treatment.16 With few exceptions, most private health insurance plans do not currently cover OTC products.17 If the new HHS guidelines allow private insurers to require a prescription for FDA-approved OTC contraceptives, it will create a barrier for those with private insurance as well.4
The public health consequences of lack of access to contraceptives, including condoms, are well documented. Half of all pregnancies in the United States—over 3 million per year—are unintended.18 Some 17.5 million women in the United States depend on publicly funded family planning services to support their decisions about when and whether to have a child.19 STIs continue to be a serious public health problem, and their prevalence reflects significant health disparities. For example, infection with Chlamydia trachomatis, the most common bacterial STI, can result in pelvic inflammatory disease, ectopic pregnancy, infertility, premature rupture of membranes and preterm birth, and neonatal pneumonia.20 In 2008, Black adolescents aged 15 to 19, followed by Black women aged 20 to 24, had the highest rates of chlamydia; Latinas experienced chlamydia rates 3 times that of non-Latina White women.21 The annual cost of STIs to the US health care system is estimated to be as much as $15.9 billion.21 Access to barrier contraceptives is essential to improved maternal health and birth outcomes. In addition, pregnancy planning and preventing unintended pregnancy play a critical role in reducing poor birth outcomes for women with chronic diseases.22
In addition to family planning drugs and supplies that are currently approved for OTC sale, there is growing interest in considering whether oral contraceptives and possibly other hormonal methods might also be appropriate for a switch from prescription to over the counter.23,24 A growing body of evidence suggests that women could safely use oral contraceptives if they were available over the counter and that contraceptive uptake and continuation might increase if this method were available directly in a pharmacy.25-28 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.29 It is critical that insurance coverage policies not obstruct advances that otherwise might benefit the nation’s public health. Other possible concerns about making contraceptives available over the counter include the possibility that this would encourage risk-taking among adolescents. A review of the evidence on emergency contraception did not find that improving access to this method through education and advance provision increased adolescents’ sexual or contraceptive risk-taking behavior.30
Recognizing the public health benefit of improved access to contraception, including barrier methods to prevent STIs, APHA urges—
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