Oral Contraceptive Pills
For over 50 years, American women have relied on oral contraceptive pills to prevent pregnancy. Oral contraceptives are now the most widely used form of contraception and are also commonly used to manage other health conditions. In the U.S., daily oral contraceptive pills have traditionally only been available with a prescription, but current legislative and advocacy efforts in some states have focused on broadening access to oral contraceptives by eliminating the requirement that women first have an in-person clinical visit. This factsheet provides an overview of oral contraception, discusses private insurance and Medicaid coverage, and reviews emerging strategies to promote and expand women’s access to oral contraceptives.
In 1960, the Food and Drug Administration (FDA) approved the sale of Enovid for use as the first oral contraceptive. Controversial from its earliest days, in 1965, the Supreme Court ruling in Griswold v Connecticut upheld married women’s rights to contraception, followed by Eisenstadt v Baird which extended the right to single, unmarried individuals.1
Oral contraceptive pills (OCP) consist of the hormones progestin and estrogen, or only progestin, and must be taken orally once per day in order to prevent pregnancy. Currently, there are three different types available on the market: the combination pill, the progestin-only pill, and the continuous use pill. The three formulations vary in their chemical hormonal composition as well as regimen for use (Table 1). Different brands further add to the diversity of OCP available by altering the type and/or dose of hormones. Emergency contraceptive pills are also a type of OCP, consisting of the progestin levonorgestrel, but are not intended for daily use. Rather, they are used to prevent pregnancy after unprotected sex.
|Table 1: Types, Composition and Regimen for Daily Oral Contraceptive Pills|
|Type and Composition||Regimen|
|Combined Pill:2 Consists of estrogen and progestin
Examples: Yaz, Yasmin, Loestrin (iron-containing)
|21-day packs: 1 pill per day for 21 days, followed by 7 days of nonuse for menstruation
28-day packs: consist of 21 or 24 hormonal pills, depending on the brand. The remaining pills either contain estrogen only or do not have any hormones.
|Progestin Only: Consists of progestin
Examples: Norenthindrone (Micronor), Norgestrel
|28 day packs, and all pills are active.
Suggested to be taken at the same time every day within a three hour window.
|Extended/Continuous Use:3 Consists of estrogen and progestin
Examples: Seasonale, seasonique, Lybrel
|90-day packs: 81 days of active hormone pills followed by 7 inactive pills, and/or low dose estrogen (results in 4 periods per year)
365 day pack: consist of 365 hormonal pills with no inactive pills.
Both the combined and progestin-only pills are highly effective with perfect use, with a failure rate (rate at which women become pregnant while using the contraceptive) less than 1%. However, the failure rate with “typical use” is 9%,4 which accounts for inconsistent or incorrect use.
The pill was the first FDA-approved contraceptive to be used in the U.S., and is still the most commonly used form of contraception. In 2013-2015, the most recent year for which there are national data, approximately a quarter (25.3%) of women age 15-44 who currently use contraception reported using the pill as their method of choice, a decline from 30.6% in 20025 (Figure 1). At the same time, there has been a rise in use of IUDs, which have been promoted by several medical groups in recent years.
Among women who use any form of contraception, OCP use is higher among younger women, with 44.5% of women ages 15-24 using the pill, compared to 24.9% of women ages 25-34, and 12.1% women ages 35-44. White women are more likely to use OCP than Hispanic or Black women. Use also increases with higher educational attainment (Figure 2).
OCPs are primarily used for pregnancy prevention, but they can also be used to address other health conditions, particularly menstrual-related disorders such as menstrual pain, irregular menstruation, fibroids, endometriosis-related pain, and menstrual-related migraines. Use of combined pills for acne has been formally approved by the FDA for specific brands.6 While most (86%) women who use OCP take them to prevent pregnancy, 14% use them solely for non-contraceptive reasons.7
Oral contraceptives are safe for most women.8 Possible side effects include headache, nausea, breast tenderness, and breakthrough bleeding. The combined hormonal pills may be associated with a small increased risk of deep vein thrombosis, heart attack and stroke for some women.9 Findings from one study suggest small increases in the likelihood of first depression diagnosis with the use of hormonal contraception, including both oral combined and progestin-only pills.10
Insurance Coverage and Financing of Oral Contraceptives
While OCP have been available since the mid 1960’s, they were not always covered by insurance plans in the same way as other prescriptions drugs. In the early 1990’s this became the focus of legislative action, first at the state and then the federal level. State legislatures began passing “contraceptive equity” laws which typically required that plans offering prescription drug coverage also cover contraceptives on the same terms as other prescriptions. Some state laws went further to require that plans cover all FDA-approved contraceptives. However, these state laws only applied to plans that were regulated by the state but not self-funded or self-insured plans, which cover most workers with employer-sponsored insurance and are federally regulated through ERISA.11 Minimum coverage standards for employer-sponsored plans were established in 2000, when a federal ruling from the Employment Equal Opportunity Commission found it unlawful under the Civil Rights Act for plans to deny coverage for contraceptives if they covered other preventive prescription drugs and services.12 By 2010, 28 states required insurers that cover prescription drugs to provide coverage for the full range of FDA-approved contraceptives.13 These requirements, however, did not address cost sharing, and a 2010 study found that women had to pay 53% of cost of OCP under their private insurance plan.14
Private Insurance and the ACA
In 2010, the Affordable Care Act (ACA) took state laws further by requiring most private plans (including self-funded, small and large group, and individual plans) to cover a wide range of recommended preventive services, without cost to policyholders. In 2011, HRSA, following recommendations issued by the Institute of Medicine, added that all FDA-approved contraceptive methods and patient counseling for women with reproductive capacity, as prescribed by a health care provider be included as a preventive service.15
The policy requires that most private health insurance plans cover at least one form of each of the 18 FDA-approved contraceptive methods for women as prescribed without cost sharing.16 This means that plans must cover at least one of each of the three different types of oral contraceptives – the combined pill, the progestin-only pill and the continuous use pill – though it is up to an insurer’s discretion using reasonable medical management practices whether to cover a brand name or generic contraceptive if both are available.17 Insurers are required to cover other contraceptives if medically necessary, and must provide a process for policyholders to request coverage of a contraceptive that is not already covered without cost sharing by the plan. Insurers may also require step therapy and prior authorization before covering a different pill.18
Since the implementation of the ACA’s contraceptive coverage provision, fewer women are paying out of pocket for contraceptives.19 The share of reproductive age women experiencing out-of-pocket spending on oral contraceptive pills declined from 20.9% in 2012 to 3.6% in 2014. This decline accounts for nearly two-thirds (63%) of the drop in out-of-pocket spending on retail drugs during this time period.
Federal law has long required state Medicaid programs to cover family planning services and supplies without cost sharing and provides states with an enhanced federal match for providing these services. States that expanded Medicaid under the ACA must follow the ACA requirements for private plans and are required to cover all 18 FDA-approved contraceptive methods for women. There is no similar requirement for populations that were traditionally eligible for full-scope Medicaid or through a Medicaid family planning expansion program, and there is variation between states on the specific services that are covered.20
Since the passage of the ACA, some states have looked to strengthen its contraceptive coverage requirement. For example, in 2014 California passed the Contraceptive Coverage Equity Act of 2014 which extends the ACA’s coverage policy beyond private plan beneficiaries to all Medicaid managed care enrollees, regardless of whether they qualify as a result of the ACA expansion or through traditional pathways.
Coverage for oral contraceptives is also required in the Indian Health Service, the federal program that provides care on or near Indian reservations as well as in the Tricare program for active military personnel and their dependents. Coverage for oral contraceptives is not required under Medicare, the federal program for seniors 65 and older as well as younger adults with permanent disabilities. Medicare beneficiaries that have enrolled in private Medicare Advantage plans or who have opted in to the Medicare Part D prescription drug benefit may have coverage for oral contraceptives, but the scope of coverage varies between plans.
Expanding Access to Contraception
In recent years, there has been public debate and emerging state policy action to expand the availability of daily oral contraceptive pills through different mechanisms. Approaches that are being considered include: making OCP available over-the-counter without a prescription; expanding the ability of pharmacists to furnish OCP without the need for a clinical visit; extending the supply amount that is dispensed at one time; and using mail-based online services or smartphone applications.
Over the Counter (OTC)
In 2011, one third of women at risk for unintended pregnancy who tried to obtain a prescription for contraception reported having trouble doing so.21 Research suggests that OTC access would increase the use of contraception and facilitate continuity of use.22 It could also allow women to save time spent on travel, at doctor’s office, and off work. The American Academy of Family Physicians and the American Congress of Obstetricians and Gynecologists have endorsed the concept of making some oral contraceptives available OTC and the issue has garnered public support. In a national survey, 62% of women reported that they supported OTC access of OCP, and 37% said they would be likely to use it.23
The switch from prescription only to OTC availability requires FDA review and approval. This action is typically triggered by the manufacturer’s petition for an FDA review, can take upwards of three or four years, and a separate review is required for each product. In order for the FDA to approve the conversion to OTC status a drug must meet certain criteria:24 users can easily diagnose need for the drug and monitor use without clinician screening; the drug must have low toxicity and low potential for abuse or interactions with other drugs; the drug cannot have significant toxicity if overdosed; and the drug must not have properties that make it impractical for OTC use.
Research shows that OTC oral contraception generally meets these requirements,25 and women can effectively use checklists to identify contraindications.26 One study found 96% of cases demonstrated agreement between women’s assessment of contraindications using the checklist and a clinician’s independent evaluation.27 Currently, Plan B emergency contraception and its generic equivalents, which contain a higher dose of progestin only (found in OCP), is available OTC.28 In December 2016, HRA Pharma and Ibis Reproductive Health announced that they jointly were in partnership to submit an application to make a progestin-only pill available for OTC use in the U.S. The progestin-only pills have fewer and more rare contraindications than combined pills, making them a better candidate for FDA approval for OTC use.
The ACA currently requires no-cost coverage for contraceptives, but only when the method is prescribed. Legislation at the federal or state level, or administrative changes to the ACA’s preventive services policy would be needed to define coverage to include non-prescribed contraceptives, and members of Congress have introduced legislation addressing this issue.29 At the state level, Maryland became the first state to enact such a law, effective January 2018, requiring insurers to cover OTC contraceptives without a prescription with the same cost-sharing rules that apply to prescription contraceptives. Illinois and Oregon have passed similar laws since then.
Another avenue that is gaining support in some states allows pharmacists to furnish or dispense OCP without first requiring an in-person medical visit to a physician. As of August 2017, eight states and D.C. allow pharmacists to prescribe certain self-administered contraceptives to women (Figure 3). All of these states allow pharmacists to prescribe at least oral contraceptives, but states vary in other details, such as a minimum age requirement, the type of contraceptive that pharmacists can prescribe, the length of the supply, and if the patient needs a prior prescription from a physician. In Oregon30 and Colorado31, women can obtain self-administered oral or transdermal contraceptives (i.e. the pill or the patch) at a pharmacy, but individuals younger than 18 must obtain their first contraceptive prescription from a physician, and subsequently may obtain contraception from a pharmacist.32 State laws in California, Hawaii, Maryland, and New Mexico33 do not pose age restrictions or require prior prescriptions from physicians and apply to all self-administered contraception including Depo Provera. Washington and Tennessee state policies allow pharmacists to prescribe oral contraceptives under collaborative therapy agreements. 34,35
Another approach to facilitate access to oral contraceptives involves increasing the dispensing period of contraceptives to 12 months per prescription. Currently, dispensing patterns vary by insurer, with many plans limiting supply of pills to one-to-three month periods.36 Providing women with a longer lasting supply of pill packs may lead to more consistent contraceptive use.37 Women who receive a one-year supply have been found to be 30% less likely to have an unintended pregnancy compared to women receiving a one to three month supply.38 In 2015, Oregon heralded the movement of extended supply and passed a law requiring insurers to pay for a three-month supply of contraceptives when first prescribed, followed by a 12-month supply of contraceptives.39 Laws requiring coverage for 12 months of oral contraceptives have since been enacted in California, Colorado, D.C., Hawaii, Illinois, Maine, Nevada, New Mexico, New York, Vermont, Virginia, and Washington.
Online Services and Smartphone Applications
A new intermediary market has emerged between health care providers and the patient that may decrease barriers to obtaining the pill. Certain online services and web applications offer options for patients to speak with providers by video, get prescriptions, and order birth control pills through mail delivery. However, full coverage of the cost is not consistent between companies. One app, Nurx, partners with physicians, pharmacies and health insurers to ship OCP free of charge for women with insurance, or for a fee for women without insurance. Other services, such as Maven and Planned Parenthood’s application, require individuals to have a video consultation with a physician before receiving the prescription. The cost varies based on the app, and often are a flat fee per consultation.
Oral contraceptives are the most commonly used form of prescription contraception in the U.S. As a result of the ACA, women with private insurance and Medicaid receive no-cost coverage for OCPs. Nationally there has been some discussion of making OCP available over-the-counter, but this has not been approved by the FDA. Some states are now considering policies to further enhance access, particularly through pharmacies and insurance coverage for longer lasting supplies.
The ruling in Eisenstadt v Baird established that the Massachusetts law barring unmarried individuals from contraception while giving married couples that right was a violation of the Equal Protection Clause of the Fourteenth Amendment.
U.S. Food and Drug Administration. Birth Control: Medicines to Help You. December 2015.
U.S. Food and Drug Administration. Office of Women’s Health. Birth Control Guide.
Trussell J. Contraceptive failure in the United States. Contraception. May 2011; 83(5):397-404.
Centers for Disease Control and Preventive. National Health Statistics Reports. Current Contraceptive Use and Variation by Selected Characteristics Among Women Aged 15-44: United States. 2011-2013.
Maguire K, & Westhoff C. The state of hormonal contraception today: established and emerging noncontraceptive health benefits. American Journal of Obstetrics and Gynecology. June 2011.
Guttmacher Institute. Beyond Birth Control: The Overlooked Benefits of Oral Contraceptive Pills. November 2011.
American Congress of Obstetricians and Gynecologists. FAQs: Combined Hormonal Birth Control: Pill, Patch, and Ring. July 2014.
Skovlund C, Morch L, Kessing L, & Lidegaard O. Association of Hormonal Contraception with Depression. JAMA Psychiatry. September 2016.
Kaiser Family Foundation and Health Research Educational Trust. Employer Health Benefits Survey 2000 Annual Report. September 2000.
U.S. Equal Employment Opportunity Commission. Decision- Contraception. December 2000.
Sobel L, Beamesderfer A, & Salganicoff A. Private Insurance Coverage of Contraception. Kaiser Family Foundation. July 2015.
Guttmacher Institute. The Case for Insurance Coverage of Contraceptive Services and Supplies Without Cost-Sharing. March 2011.
Grandfathered plans are exempt from this requirement. These are plans in existence prior to March 23, 2010 that have not made significant changes in coverage policies. In 2015, 25% of covered workers were in grandfathered plans.
Kaiser Family Foundation. Minimum Contraceptive Coverage Requirements Clarified by HHS Guidance. May 2015.
Sobel L, Salganicoff A, & Kurani N. Coverage of Contraceptive Services: A Review of Health Insurance Plans in Five States. Kaiser Family Foundation. April 2015.
Cox C, Damico A, Claxton G, & Levitt L. Examining high prescription drug spending for people with employer sponsored health insurance. Kaiser Family Foundation. October 2016.
Ranji U, Bair Y, & Salganicoff A. Medicaid and Family Planning: Background and Implications of the ACA. Kaiser Family Foundation. February 2016.
Grindlay K & Grossman D. Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy. Journal of Women’s Health; 25(3): 249-254. March 2016.
Potter JE, McKinnon S, Hopkins K, Amastae J, Shedlin MG, Powers DA, & Grossman D. Continuation of prescribed compared with over the counter oral contraceptives. Obstetrics and Gynecology; 117(3): 551-557. March 2011.
Grossman D, Grindlay K, Li R, Potter JE, Trussell J, & Blanchard K. Interest in over-the-counter access to oral contraceptives among women in the U.S. Contraception; 88(4): 544-552. October 2013.
Jacobs, L. Prescription to Over-the-Counter Drug Reclassification. American Academy of Family Physicians. May 1998.
Grossman D. Over-the-counter access to oral contraceptives. Obstetrics and Gynecology Clinics of North America. December 2015.
Xu H, Eisenberg DL, Madden T, Secura GM, & Peipert JF. Medical contraindications in women seeking combined hormonal contraception. American Journal of Obstetrics and Gynecology; 210(3): 210.e1-210.e5. March 2014. Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, & Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstetrics and Gynecology; 112 (3): 572-578. September 2008.
Shotorbani S, Miller L, Blough DK, & Gardner J. Agreement between women's and providers' assessment of hormonal contraceptive risk factors. Contraception; 73(5): 501-506. May 2006.
U.S. Food and Drug Administration. FDA News Release. FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential. June 2013.
Pharmacists use patient self-administered surveys and patient interaction to determine which contraceptive is suitable. Oregon State Pharmacy Association, FAQs.
Colorado Department of Regulatory Agencies. State Board of Pharmacy: News.
This requirement sunsets in two years.
New Mexico Regulation and Licensing Department. Protocol for Pharmacist Prescription of Hormonal Contraception.
State of Tennessee, Public Chapter No. 942, Senate Bill No. 1677. Tennessee state law also pertains to women 18 and older.
Guttmacher Institute. Moving Oral Contraceptives to Over-the-Counter Status: Policy Versus Politics. November 2015.
Steenland MW, Rodriguez MI, Marchbanks PA, & Curtis KM. How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other measures of consistent and correct use? A systematic review. Contraception; 87(5):605-610. May 2013.
Foster DG, Hulett D, Bradsberry M, Darney P, & Policar M. Number of Oral Contraceptive Pill Packages Dispensed and Subsequent Unintended Pregnancies. Obstetrics and Gynecology; 117(3):566-572. March 2011.
Oregon Legislative Assembly, 2015 Regular Session, HB3343- Relating to Contraceptives.