Federal action could help 56.8 million additional women of reproductive age gain true insurance coverage for over-the-counter contraceptives

Reproductive health, autonomy, and equity is critical

• The introduction of the first daily over-the-counter (OTC) oral contraceptive has great potential for reproductive health and autonomy in the United States—but only if it is affordable.

• Federal action on coverage of OTC contraception could greatly impact reproductive health, autonomy and equity, particularly in the wake of the Supreme Court’s Dobbs decision and in the face of other threats to reproductive rights.

Federal action on coverage would massively expand contraceptive affordability

• Federal officials have the authority under the Affordable Care Act and other laws to require nationwide coverage of OTC contraceptives without a prescription in private insurance plans, Medicaid and other public programs.

• Changes to federal policy would have an enormous impact. An additional 56.8 million women would gain true OTC coverage of contraceptives, including 42.5 million women aged 15-49 with private insurance, as well as 12.9 million with Medicaid or Children’s Health Insurance Program coverage and 1.4 million with Medicare, military or veterans coverage.

• There is precedent for mandating coverage of OTC contraceptives without a prescription. Already, policies in nine states require some OTC contraceptive coverage in state-regulated private insurance plans and/or Medicaid.

7.6 million uninsured women also need affordable contraception

• Policymakers must also act to make OTC contraceptives free or affordable for 7.6 million women aged 15-49 who are uninsured.

The Food and Drug Administration’s (FDA) July 2023 approval of Opill as the first daily OTC (OTC) oral contraceptive has the potential to be a major advance in reproductive health and autonomy. Opill, a progestin-only pill (POP) or “mini-pill,” is now the most effective method of contraception available without a prescription. A highly effective OTC contraceptive option should allow people to bypass major logistical and financial barriers that are often attached to prescription options, including finding a regular health care provider; taking time off from work or other responsibilities; the insurance cost-sharing or other out-of-pocket costs for an office visit; and any necessary expenses for travel and child care.

Another reason why the advent of a daily OTC oral contraceptive is revolutionary is because the pill is the most common reversible form of contraception, used by 21% of all regular contraceptive users. Notably, more than nine in 10 oral contraceptive users are currently using a combined oral contraceptive (COC or “the pill”) rather than a POP. At least one manufacturer is currently working to bring a COC over the counter in the next several years.

However, the full potential of Opill or any other OTC contraceptive options, current or future, will only be reached if they are affordable for consumers. Cost can be a severe barrier, particularly for many young people and people with low or no income, and studies have indicated that the potential demand for an OTC oral contraceptive is highly dependent on how much it would cost out of pocket.

Insurance coverage for OTC contraceptives—with no out-of-pocket costs and without a prescription—could help make these options affordable for the vast majority of people in the United States who need them, including the 90% of women of reproductive age (15-49) who had some form of private or public health coverage in 2022.

However, health insurance in the United States has not traditionally provided this standard of coverage for OTC products. Many health plans limit coverage to prescription drugs and devices. When plans do cover OTC products—such as when they are required to cover OTC contraceptives and other preventive OTC products under the Affordable Care Act (ACA)—they typically force enrollees to obtain a medically unnecessary prescription for the product to be covered. The prescription barrier for coverage becomes even more untenable now that the mini-pill is available without a prescription and the combined pill is currently under review at the FDA and expected to be available OTC soon.

Fortunately, the trend toward coverage for OTC contraception has been building in the states. Currently, nine states require state-regulated private insurance plans and/or Medicaid to cover some OTC contraception without a prescription. There is not a uniform standard for which methods to cover among these states – some policies are limited to emergency contraception or condoms, and some are broader. Other states have taken lesser steps toward this goal, such as facilitating coverage of OTC contraceptives by issuing a state-wide prescription (known as a “standing order”) for products such as specific emergency contraceptives, or by granting pharmacists the authority to prescribe certain contraceptives.

Moreover, federal policymakers have signaled that they may build on this precedent and require coverage of OTC contraceptives without a prescription for private insurance plans nationwide. A June 2023 executive order directed federal agencies to “promote increased access to affordable OTC contraception.” Signaling potential rulemaking, an Oct. 2023 Request for Information by the Departments of Health and Human Services, Labor and the Treasury sought to gather public input on the potential benefits, costs, logistics, and challenges of requiring coverage of OTC preventive items and services without a prescription. The federal government has the policy levers to advance such coverage in nearly all U.S. private health plans, as well as in numerous public insurance programs, such as Medicaid, Medicare, the Children’s Health Insurance Program (CHIP) and coverage for federal employees, the military, veterans and their families.

Policymakers in several states have taken steps in recent years to require coverage for OTC contraceptives, often specifying that a health plan may not require a prescription to trigger coverage.

Private insurance plans

As of the beginning of 2024, seven states require state-regulated private insurance plans to cover at least some OTC contraceptives without a prescription: California, Colorado, Maryland, New Jersey, New Mexico, New York and Washington. Collectively, these laws benefit about 7.5 million women aged 15-49: That is the number of such women (as of 2022, the most recent year of data available) living in those seven states who had state-regulated private health insurance.

Six of those seven state laws—covering 6.1 million women aged 15-49—are written broadly enough to cover Opill and other future OTC oral contraceptives. (New York’s requirement is the exception, limited to emergency contraception.)

State-regulated private insurance plans include fully insured plans bought by employers on behalf of their employees, as well as private plans purchased by individuals or families on the ACA’s health insurance marketplaces or through other means. Notably, state laws do not apply to health plans from employers that self-insure, which accounted for about 55% of enrollees in employer-sponsored plans in 2022. Only federal law can regulate self-insured employer plans.

Medicaid

The situation is similar for Medicaid: As of the beginning of 2024, seven states require Medicaid to cover at least some OTC contraceptives without a prescription: California, Illinois, Maryland, Michigan, New Jersey, New York and Washington. These laws benefit about 6.0 million women aged 15-49.

However, only California and Washington’s laws—covering 2.8 million women 15-49—would clearly cover OTC oral contraceptives. (The other five laws are limited to emergency contraceptives and/or condoms.)

Summary

In total, this means that 13.5 million women aged 15-49 in nine states already have coverage for at least some forms of OTC contraceptives, without out- of-pocket costs and without having to obtain a prescription. This coverage may not yet be the national standard, but there is significant evidence of a growing trend that recognizes the importance of covering OTC contraception without a prescription.

As detailed previously, federal policymakers have the authority under the ACA to require coverage of OTC contraceptives, without cost-sharing and without a prescription. However, the federal government has not exercised that authority, instead recommending but not requiring that health plans eliminate the prescription requirement.

If federal policymakers updated the ACA requirement to explicitly require coverage of OTC contraceptives without a prescription, the benefits would be enormous. Of the 48.6 million women aged 15-49 with private insurance, 6.1 million in six states have state-regulated health insurance that is required to meet this standard of coverage for OTC oral contraceptives. That means that a new federal requirement to cover OTC oral contraceptives without a prescription just under the ACA would directly benefit 42.5 million women aged 15-49 nationwide.

That number includes all women aged 15-49 in self-insured employer plans, as well as those in state-regulated private plans in 44 states and the District of Columbia. It also includes enrollees in the Federal Employees Health Benefits Program, which is not technically governed by the ACA’s contraceptive coverage requirement but which has nevertheless consistently followed those rules.

The ACA requirement extends beyond private insurance coverage to also include many people enrolled in Medicaid—most notably, everyone enrolled in the ACA’s major Medicaid expansion, covering adults with family incomes under 138% of the federal poverty level. Forty states and the District of Columbia have adopted and implemented this expansion, as of April 2024. These expansions accounted for roughly one-quarter of all Medicaid enrollees nationwide in 2022.

Moreover, an updated ACA requirement would likely benefit most or all of the remaining Medicaid enrollees as well, because states have generally aligned their contraceptive coverage practices across their entire Medicaid program. The federal government has additional policy levers it could use to require or facilitate coverage for OTC contraceptives without a prescription throughout the entire Medicaid program and the related CHIP.

So in practice, an updated ACA requirement to cover OTC oral contraceptives without a prescription, along with additional federal action, might benefit as many as 12.9 million women aged 15-49 with Medicaid or CHIP coverage living in 48 states and the District of Columbia. (That would be in addition to the 2.8 million in California and Washington who already have this coverage.)

Finally, federal officials have opportunities to require or facilitate the coverage and availability of OTC contraceptives without a prescription in other federal programs, including Medicare, the Military Health System and the programs run by the Department of Veterans Affairs. An additional 1.4 million women aged 15-49 rely on these programs for contraception coverage.

Altogether, federal action has the potential to reach 56.8 million women of reproductive age, including those in private plans, Medicaid and other federal coverage programs.

There is one group that would not be helped by federal or state action to require health plans and coverage programs to cover OTC contraceptives without a prescription: the uninsured. The ACA dramatically reduced the number of uninsured people in the United States, but it could not close those gaps entirely. Millions of people—including 7.6 million women aged 15-49 in 2022—remain without health insurance.

One avenue for addressing this problem would be federal and state efforts to further expand health coverage. Such actions could include state ballot initiatives and other efforts to adopt the ACA’s Medicaid expansion in the remaining 10 states; offering further subsidies for ACA marketplace coverage to address affordability concerns; eliminating policies that exclude many immigrants from coverage; and helping people learn about and enroll in subsidized marketplace and Medicaid coverage for which they are eligible but not using. 

In addition, there may be more narrowly tailored ways of making OTC contraceptives free or affordable for people without health coverage, including availability for free or at a discount at publicly supported health clinics, drug companies’ patient assistance programs, or coupons offered by new government programs or private entities.

There is clear momentum toward a reality where health insurance in the United States would routinely include coverage for contraceptive products obtained over the counter without a prescription. Already, 13.5 million women aged 15-49 in nine states have private or Medicaid coverage for one or more types of OTC contraception, without having to obtain a prescription.

The federal government can and should turn this momentum into a nationwide standard for private insurance, Medicaid and other public insurance programs. Doing so via updates to the ACA’s contraceptive coverage requirement would benefit 42.5 million women aged 15-49 across the country who rely on private insurance. That policy change, in combination with other federal actions, could similarly extend coverage of OTC oral contraceptives without a prescription to 12.9 million women aged 15-49 with Medicaid or CHIP coverage. Other policy changes could benefit 1.4 million women with Medicare, military or veterans coverage. Altogether, federal policy changes could extend coverage of OTC oral contraceptives without a prescription to an additional 56.8 million women.

Beyond these steps, the federal government should also work to extend coverage and/or make OTC contraceptives free or affordable for the millions of U.S. residents who remain uninsured. And it should devote attention and resources to implementation, education and enforcement efforts, to make sure that coverage requirements translate into coverage that works.

Doing all of this could help millions of people overcome current barriers to consistent and effective contraceptive use. That, in turn, would result in more reproductive autonomy and would enable enrollees to avoid unplanned pregnancies, to better time and space their pregnancies, and to reduce their chances of an unhealthy pregnancy and birth, thereby improving health outcomes. These steps would also advance the goal of reproductive equity, because barriers to contraceptive use fall hardest on people of color, young people, immigrants, LGBTQ+ people, low-income people and people with disabilities, among others.

Affordable new contraceptive options are particularly salient in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which eliminated the federal constitutional right to abortion. The Biden administration has made a strong commitment to protecting and expanding access to contraceptive services and supplies post-Dobbs, and requiring private and public health plans to cover OTC contraceptives without cost-sharing and without a prescription would be a significant action toward its stated goals.

In addition, federal requirements would provide additional protections against potential state-level restrictions. Given the long history of state restrictions on reproductive rights, including policies targeting contraceptive coverage, access and funding, it is fair to expect that conservative state policymakers might attempt to restrict coverage for and access to OTC oral contraceptives, now that the first such product has been approved by the FDA. Such restrictions might take the form of excluding OTC contraceptives from Medicaid or private insurance coverage or imposing an age restriction or identification requirement to purchase OTC contraceptives. At least some of these types of potential restrictions would be preempted by a federal requirement for health plans to cover OTC contraceptives without cost-sharing and without a prescription.

Finally, a well-communicated, -implemented and -enforced requirement for health plans to cover OTC contraceptives could be an opportunity to help transform the broader health insurance system. Health plans do not exclude coverage for OTC products because they are medically unnecessary or ineffective; they exclude these healthcare products because doing so helps plans to shift costs to consumers and maximize their own profits. This status quo—with its arbitrary distinction between prescription and OTC products—is antithetical to the goals of the ACA of improving consumers’ health coverage and health outcomes.

For a more extensive glossary, see healthcare.gov

Affordable Care Act (ACA) 

A 2010 federal law that expanded eligibility for various types of private and public health insurance and established new federal requirements for health insurance.

Combined oral contraceptive (COC or “the pill”) 

The most commonly used type of hormonal birth control pills in the United States. This oral contraceptive contains both estrogen and a progestin. (See “Progestin-only pill” for the other type of birth control pill).

Fully insured employer plan

A type of health plan in which an employer purchases coverage for their employees from an insurance company, paying monthly premiums in exchange for the insurance company taking on the risk of unexpected costs; can be regulated by both federal and state governments.

Over-the-counter (OTC) product 

A medication or medical device that has been approved by the U.S. Food and Drug Administration to be sold to consumers without a prescription from a medical provider.

Progestin-only pill (POP or “the mini-pill”) 

One of two main types of hormonal birth control pills.  The POP is an oral contraceptive that only contains progestin; the first over the counter oral contraceptive, Opill, is a progestin-only pill. (See “combined oral contraceptive” for the other type of birth control pill).

Self-insured employer plan

A type of health plan in which an employer itself takes on the responsibility and risks of paying medical claims for employees (with or without assistance from an outside company in administering the plan); can be regulated only by the federal government.

State-regulated private insurance

Includes fully insured plans bought by employers on behalf of their employees, as well as private plans purchased by individuals or families on the ACA’s health insurance marketplaces or through other means.

The blue shading in this table indicates the number of individuals who fall under state requirements for coverage of OTC oral contraception in state-regulated private insurance plans. The green shading in this table indicates the number of individuals who fall under state requirements for coverage of OTC oral contraception in Medicaid plans. Because these individuals are already subject to state-level requirements, they are not included in the totals in the final column, which indicates those who would benefit from new federal requirements.

Methods

State contraceptive coverage policies: The first step in this analysis was to identify and analyze state-level policies requiring coverage of OTC contraceptives in either state-regulated private health insurance plans and/or the state’s Medicaid program. CAI’s analysis built on prior work by KFF, Power to Decide and the Guttmacher Institute in tracking and analyzing state contraceptive coverage policies. We identified all relevant policies that had been put in place by January 2024 and assessed whether they would apply to an OTC oral contraceptive specifically.

Insurance coverage for women of reproductive age: In order to determine how many women were impacted by current state coverage policies, we needed state-level data on insurance coverage for women of reproductive age (aged 15-49). We started with a KFF analysis of 2022 data from the Census Bureau’s American Community Survey (ACS), the most recent year available. That analysis included six categories of insurance coverage: Employer, Non-Group, Medicaid (including CHIP), Medicare, Military (including Veterans Administration) and Uninsured.

We then split the Employer category into two groups — fully insured employer plans and self-insured employer plans — using a KFF analysis of 2022 data from the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey.

Women impacted by state coverage requirements: To estimate the number of women aged 15-49 impacted by state requirements on private health insurance policies, we included all in a given state who were either in fully insured employer plans or in non-group plans (which includes private plans purchased by individuals or families on the ACA’s health insurance marketplaces or through other means). For women aged 15-49 impacted by state Medicaid policies, we included all in a given state with Medicaid coverage.

Women impacted by potential federal action: Finally, we looked at three possible categories of federal action. For potential impact on privately insured women via a change to the rules governing the ACA’s contraceptive coverage requirement, we included women aged 15-49 nationwide who were in fully insured employer plans, self-insured employer plans, or non-group plans. We then subtracted out privately insured women in six states who were already subject to a state-level requirement to cover OTC oral contraceptives without a prescription.

For potential impact on women in Medicaid and CHIP, we included women aged 15-49 nationwide who were in these programs. We then subtracted out women in two states who were already subject to a state-level Medicaid requirement to cover OTC oral contraceptives without a prescription.

For potential impact on women in other federal programs, we included women aged 15-49 nationwide who had Medicare coverage or Military coverage (which also includes coverage through the Veterans Administration).

Limitations: These estimates are not a precise accounting of the number of people who might be affected by state or federal policies. First, women aged 15-49 are a group especially likely to benefit from coverage for OTC contraceptives, but other people (including people who identify as men and people outside of that age range) may also benefit.

Second, the insurance categories used in this analysis do not always match up perfectly with state and federal policy requirements. For example, the ACS data include CHIP enrollees under the Medicaid category, but state and federal Medicaid policies do not automatically apply to some CHIP enrollees. Similarly, the ACS data on employer coverage include enrollees in the Federal Employees Health Benefits Program, which is not technically governed by the ACA’s contraceptive coverage requirement.

Third, these estimates do not account for people whose health insurance is exempted from federal or state coverage requirements. For example, we were unable to account for people in ACA grandfathered plans, which are exempt from the ACA’s contraceptive coverage requirement. Similarly, we were unable to account for people in plans with religious exemptions to the federal ACA requirement and/or state-level contraceptive coverage requirements.

Finally, these estimates are based on state and federal policies as written in statute, regulation, or other form. We were unable to account for whether these policies are being fully enforced as written. As noted above, oversight and enforcement is critical to ensuring that these policies have their intended impact.

Adam Sonfield

Adam Sonfield is the owner of Sonfield Policy Solutions LLC, where he provides consulting services on health care policy and sexual and reproductive rights. He has expertise on Medicaid and private insurance coverage for reproductive health services, the Title X national family planning program, and religious and moral exemptions to providing coverage and care. He worked for 24 years at the Guttmacher Institute, serving as executive editor for the organization’s policy analysis work and as a policy analyst, advocate, writer, editor, researcher and spokesperson.

Dana Singiser

Dana Singiser, co-founder of CAI, is a partner at Keefe Singiser Partners where she largely represents progressive non-profit organizations. She is a reproductive health care policy expert with over 25 years of policy, political, campaign and legal experience. Prior to Keefe Singiser Partners, Dana served as senior vice president for Policy, Campaigns, and Advocacy at Planned Parenthood Federation of America. Dana also served in the Obama White House, where she worked as the special assistant to the president and a key member of the team that helped pass the Affordable Care Act.

Contraceptive Access Initiative

The nonprofit Contraceptive Access Initiative (CAI) works to increase access to contraception for all, free from stigma, bias or coercion. Our affordability campaign advances access for all, including no-cost access to over-the-counter contraceptives.

For more information about the over-the-counter affordability campaign, and to see the affordability explainer video, see www.thepillotc.org/affordability

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