The first over-the-counter (OTC) oral contraceptive, Opill, officially hit the market in March 2024, and policymakers are grappling with how to ensure that this new birth control option is accessible and affordable for everyone. While the federal Affordable Care Act (ACA) requires prescription contraception to be covered by insurance under most plans, Opill and other contraception available OTC, such as emergency contraception and condoms, currently fall outside this requirement, unless the consumer first obtains a prescription. This requirement is counterproductive and contradictory, since the U.S. Food and Drug Administration (FDA) has made the determination that a prescription is not medically necessary for consumers to use these products safely and effectively.

Thankfully, federal officials are looking to correct this situation, and the federal government has the clear executive authority to fix the inconsistency of plans covering prescription contraception but not OTC contraception. In Oct. 2023, officials issued a Request for Information to gather feedback from stakeholders and the public about how coverage of OTC preventive products could be effectively implemented without a prescription. A year later, in Oct. 2024, the government announced proposed regulations that would build on the ACA’s birth control coverage policy by requiring health plans to cover OTC contraceptives without cost-sharing and without a prescription. A 60-day public comment period will extend through the end of December, and then officials will need to review those comments and issue final regulations. If the regulation is finalized as drafted, the new requirement would take effect beginning in 2026. 

 

States have long been ahead of the federal government in requiring insurance coverage of contraceptives, with the first state laws enacted in the late 1990s — more than a decade before the Affordable Care Act (ACA) and its birth control coverage requirement. Now, states have again blazed a trail on more recent policy innovations on contraception, including around coverage of OTC contraceptives.

 
 

In the meantime, governors and their administrations have not waited for the federal government to act. These officials are leveraging their authorities to advance access in their own states and to serve as “laboratories of democracy” — experimenting with policies that might be adopted and adapted in other states, and eventually nationwide. States have long been ahead of the federal government in requiring insurance coverage of contraceptives, with the first state laws enacted in the late 1990s — more than a decade before the Affordable Care Act (ACA) and its birth control coverage requirement. Now, states have again blazed a trail on more recent policy innovations on contraception, including around coverage of OTC contraceptives.

As these policy models are implemented, it will be helpful to the federal government to learn from them. In fact, the proposed federal regulations ask for public input on a wide array of issues around implementation of OTC coverage, and the experience of states that have moved quickly on this issue will be extraordinarily valuable input. Early state actions can help to demonstrate the range of policymakers’ options; raise questions and considerations that other policymakers and stakeholders should think about; and provide preliminary lessons about what might work in at least some circumstances. 

It is too early to know what OTC access strategies will be most achievable and successful, but a review of recent executive actions and interviews with officials in several states hint at some preliminary lessons.

Governors, insurance commissioners, Medicaid agency directors and other officials can take action now, based on their existing authority and influence, without waiting for the legislature or the federal government to act. Governors and officials in at least nine states (Arizona, California, Delaware, New Mexico, New York, North Carolina, Pennsylvania, Washington and Wisconsin) moved quickly in 2024 to improve coverage and access for OTC oral contraceptives, with only Delaware doing so through new legislation.

States have authority over a wide range of health plans, including private insurance plans for employers and other large organizations, private insurance plans for individuals and families, health plans for state employees, Medicaid and the Children’s Health Insurance Program (CHIP) and coverage and access at public colleges and universities. Policymakers may need to take separate, specific actions to address OTC contraceptive access under each of these types of health coverage. For example, when Arizona Gov. Katie Hobbs issued an executive order on OTC contraceptives in May 2024, she directed five different agencies to address state employee coverage, Medicaid and private insurance, and to educate pharmacists and consumers.

Policymakers do not need to wait for agreement on a comprehensive coverage requirement. Rather, they can take incremental steps based on their current authority and knowledge. These initial steps may have important limitations and trade-offs to consider, but they can build toward additional action later and provide the experience and data to show why more action is needed and why it would be effective. For example, Arizona Gov. Katie Hobbs’ executive order immediately expanded coverage for state employees, while instructing agencies to study future policy options for other types of health insurance. Similarly, under California Gov. Gavin Newsom, the state Medicaid program has expanded coverage for Opill via a process that involves counseling and evaluation by a pharmacist — something the state could do immediately under its existing authority — while exploring policy options that would lead to a more streamlined customer experience.

States’ experience with earlier attempts to expand contraceptive access have highlighted the importance and difficulty of public education, and officials will need a communication strategy for any new policies they adopt. For example, Wisconsin Gov. Tony Evers used his Jan. 2024 State of the Union address to highlight his state’s actions to expand Medicaid coverage for OTC contraceptives without a prescription, and followed up with a press release in March when Opill hit the shelves and was added to Medicaid coverage. Both times, he described in simple terms how this coverage should work in practice at the drugstore. Officials from numerous states described their various communication efforts, such as texting and mailing Medicaid enrollees and issuing detailed bulletins to pharmacists, about expanded coverage for OTC contraception.

Health insurance has not been traditionally designed for OTC drugs and devices, and experience from prior state requirements has pointed to specific logistical problems for consumers, pharmacy staff and insurance plans. State officials will need to think up front about how to make their strategies for coverage of OTC contraceptives work as seamlessly as possible for everyone involved. For example, when the New Mexico Department of Health, under the direction of Gov. Michelle Lujan Grisham, found a pathway to cover OTC contraceptives under Medicaid (via a “standing order”; see below), it provided specific information to pharmacies about who was eligible, the specific products that were covered and procedures for billing insurance. Similarly, North Carolina’s Medicaid agency issued a bulletin in July 2024 that included detailed instructions about how to submit claims to the agency for Opill without a prescription (including how to address potential error messages); offered a $5 processing fee for the pharmacy; and specified that the drug could be dispensed in three-month supplies, with a maximum of 13 packs per year.

This is another clear lesson from earlier coverage expansions. Even a decade after the ACA’s contraceptive coverage requirement took effect, the federal government is still identifying problems with whether and how health plans are complying. For state officials to ensure that their policy changes have their intended real-world impact, it will require an investment of resources, personnel, planning, ongoing communication and dedication. For example, under Gov. Phil Scott, Vermont’s insurance regulator conducted a two-year audit of the state’s top three insurance companies, found that they had wrongly shifted more than $1.5 million in contraceptive care costs to enrollees, and ordered them to refund that money with interest. Similarly, in June 2024, New York Attorney General Letitia James announced a $1 million settlement for a health insurance company’s violations of the state’s contraceptive coverage requirements. Similar efforts will be needed for requirements related to OTC contraception.

Communication, implementation and oversight are complicated sets of tasks, but they can be eased by effective partnerships with stakeholder groups. Officials from numerous states said they leveraged existing relationships with pharmacy chains, insurance companies, industry associations, consumer groups, academic institutions and officials in other state agencies to get the word out about policy changes; figure out how best to implement them; and gather data and anecdotes about how well things are working. Regarding communication, for example, North Carolina’s Medicaid agency has encouraged pharmacies to post signs to inform Medicaid enrollees that they can obtain Opill without cost-sharing and without a prescription. New Mexico officials say they have worked with care coordinators to help educate Medicaid enrollees about OTC contraceptive coverage. Regarding implementation, Washington state officials say they are working with an outside organization that helps design health plan processes to address some of the difficulties that health plans and pharmacies have faced with implementing OTC contraceptive coverage. Finally, concerning oversight, Pennsylvania officials note that they conduct an annual survey of state-regulated insurers (in the form of a “supplemental template” that is part of insurers’ annual filings with the state), which can help assess and encourage compliance with contraceptive coverage requirements and other state rules.

There are clear, practical benefits to having a governor’s personal involvement in rolling out a state’s new coverage policy. For example, press outreach by a governor or other high-profile public figure will maximize media coverage and, as a result, help get the word out to consumers about the new policy, explain to them how OTC coverage should work and publicize resources like consumer hotlines. A public face like a governor can also wield pressure to influence the behavior of insurers and pharmacies, draw political blowback and shield public workers who are just doing their job. Notably, several governors — including North Carolina Gov. Roy Cooper, Pennsylvania Gov. Josh Shapiro and Wisconsin Gov. Tony Evers — announced OTC coverage expansions through public appearances to maximize potential press coverage and the likelihood that the information would reach the impacted population. Many states have reported low initial utilization from a lack of knowledge of new policies; media coverage stemming from a governor’s personal involvement can bridge this gap by helping consumers learn about new pathways to obtain contraception at no cost. 

Although governors and other state officials can do many things based on their existing authority, they may need to work with legislatures to expand that authority; to enact more comprehensive and effective health insurance requirements; and to ensure that new policies become permanent. In some cases, this can happen quickly: Delaware Gov. John Carney signed a new law in Aug. 2024 — just a few months after Opill became available for purchase — requiring state-regulated private health plans to cover OTC contraceptives without a prescription. Strong state laws can also allow officials to respond more quickly to changing circumstances: For example, strong existing contraceptive coverage requirements — including for OTC methods — allowed officials under California Gov. Gavin Newsom, New Mexico Gov. Michelle Lujan Grisham and Washington Gov. Jay Inslee to quickly clarify that Opill must be covered by many health plans in their states without patient out-of-pocket costs and without a prescription.

State-level policymakers and advocates have been working for years to require and facilitate coverage of OTC contraceptives, with an initial focus on OTC emergency contraceptives like Plan B, which has been available OTC for consumers of all ages since 2013. On a parallel track, many states have also expanded the authority of pharmacists to dispense oral contraceptives and other hormonal methods without a specific prescription from another health care provider. These policies have laid the groundwork for many states’ initial responses to the advent of an OTC oral contraceptive.

Prior to 2024, nine states already had policies in place that required state-regulated health plans and/or Medicaid plans to cover OTC contraceptives and, crucially, explicitly required them to do so without the enrollee first obtaining a medically unnecessary prescription from a health care provider. In six of these states, the policies appear to be written broadly enough to include OTC oral contraceptives. In the other states, the policies are limited to emergency contraception and/or condoms. Amending an existing contraceptive coverage requirement or adopting a new one would be perhaps the most obvious and direct way of ensuring that OTC oral contraceptives are affordable for people with state-regulated public and private health insurance. Delaware took just that step in Aug. 2024, amending an earlier state law (which was limited to emergency contraception and required either a prescription or a standing order) to require coverage for all forms of FDA-approved OTC contraceptives, whether with or without a prescription.

As an alternative to requiring coverage of OTC contraceptives without a prescription, some states have instead worked to negate the logistical hurdles that come with trying to obtain a prescription. One approach is a statewide “standing order”: effectively, a prescription written by a state health official for a specific product that applies to a defined group of potential consumers, such as all enrollees in a state’s Medicaid program or anyone in the state. A pharmacist can then dispense the OTC contraceptive and charge it to the customer’s insurance plan without the need for a patient-specific prescription — and without the patient having to visit a clinician to obtain that prescription (which the FDA has determined is not needed for Opill).


This statewide standing order model is particularly helpful under Medicaid, because the federal government has required that enrollees receive a prescription even for OTC drugs, if state Medicaid agencies want to receive federal reimbursement. A standing order counts for that requirement. Although state law varies in terms of whether statewide standing orders are authorized and in what circumstances, they have been used in the past by numerous states for levonorgestrel emergency contraception and naloxone (to treat opioid overdoses). Already in 2024, several states including New Mexico under Gov. Michelle Lujan Grisham and Wisconsin under Gov. Tony Evers have issued statewide standing orders for OTC progestin-only oral contraceptives.

Another way that states can help consumers reduce the burden of obtaining a prescription for OTC contraceptives is to enable pharmacists to prescribe and dispense self-administered hormonal contraceptives (often including the pill, patch, ring and shot). That means a consumer would only have to visit a pharmacy and not also a clinician’s office or clinic. The scope and mechanics of this prescribing authority varies from state to state. However, common denominators — and key ways that it differs from the statewide standing order strategy — are that it requires training for pharmacists; screening for consumers to identify potential risks; and a substantial amount of consumer-pharmacist interaction, such as counseling. In other words, it falls well short of true OTC access and coverage. 


Nevertheless, pharmacist prescribing may be a useful compromise for some consumers: not as convenient as buying an OTC product should be, but more affordable if they would otherwise be unable to use their insurance. About half of the states already allowed pharmacists to prescribe hormonal contraceptives prior to 2024, and several states including California under Gov. Gavin Newsom and New York under Gov. Kathy Hochul have leveraged these policies this year to expand access to hormonal contraceptives, including OTC oral contraceptives specifically.

As noted above, the federal government requires a prescription (a patient-specific one or something like a standing order) to leverage the federal portion of the reimbursement that Medicaid programs normally receive for medications, including select OTC drugs. States have the flexibility to forgo the federal portion of reimbursement when federal requirements are not met: They can pay for something solely with state dollars. For example, 17 states use state-only dollars to pay for abortions for people enrolled in Medicaid, because the Hyde Amendment bars federal dollars from being used for abortion in almost all circumstances. Similarly, many states use state-only dollars to provide Medicaid-equivalent coverage to certain immigrants who are ineligible for federally funded coverage.

States could use this same strategy to cover OTC oral contraceptives for Medicaid enrollees and expand access by not requiring a prescription. For example, Washington has taken that step using its existing funding authority. This is made easier by the fact that OTC oral contraceptives are inexpensive and are unlikely to become a dominant contraceptive option in the near future. 

States can leverage their own money to expand access by requiring coverage of OTC oral contraceptives without a prescription in the plans offered to state employees. This policy would directly benefit state employees and their dependents, and could have indirect benefits for other state residents by acting as a model for other health plans (some of which may be administered by the same companies that administer state employee plans). Arizona Gov. Katie Hobbs took this step in May 2024 via an executive order.

Under the ACA, states choose a “benchmark plan” from a list of options (such as a popular state employee plan or small group insurance plan). That plan serves as a model for what counts as the essential health benefits (EHBs) that individual and small-group insurance plans in the state must cover, including those sold on the ACA’s marketplaces. Under the ACA, these health plans must provide benefits that are “substantially equal” to the benchmark plan, including covered benefits and any limitations on these benefits. These individual and small group health plans are allowed to make substitutions within each of the 10 EHB categories, although states have the authority to set stricter standards that limit or prevent these sorts of substitutions. 

In practice, this means that a state can use changes to its benchmark plan as a way of influencing — or, in some states, setting requirements for — the scope and limitations of individual and small group health plans, potentially including coverage of OTC contraceptives without a medically unnecessary prescription. Arizona Gov. Katie Hobbs’ May 2024 executive order required state officials to explore new requirements for coverage of OTC contraceptives via a new EHB benchmark plan.

In cases where state officials may not have immediate authority to require health plans to cover OTC contraceptives without a prescription, they may still have other levers to encourage plans to change their coverage practices. That might include public or behind-the-scenes pressure from a governor or insurance commissioner, or guidance to health plans about best practices. For example, in April 2024, Pennsylvania Gov. Josh Shapiro and his insurance department publicly urged the state’s health plans to cover OTC contraceptives without a prescription. They announced that under new insurance guidance, plans choosing not to cover OTC contraceptives would need to explain why not and “provide additional information to verify compliance with federal law and regulations.” Later in the month, the governor issued a second press release, touting the rapid move by two major insurers in the state to cover OTC contraceptives without a prescription. With the encouragement of state officials, an example “best practice” issued through form filing guidance and follow-up with each insurer during the annual form filing review, most of the state’s other insurers have followed suit. Notably, one of the first companies to take this step, in Pennsylvania and beyond, was CVS Health, which announced that many of its health plans nationwide and its massive pharmacy benefit manager (PBM) would cover Opill without cost-sharing and without a prescription.

As state policymakers consider their options for requiring, encouraging and facilitating coverage of OTC contraceptives without a prescription, it is clear that they will need to take into account numerous issues and complications. Initial conversations with policymakers and other stakeholders have identified a sizable list.

One basic constraint for state policymakers is the scope of their authority. The balance between the executive authority of the governor and state agencies versus interventions that require state legislative action will vary from state to state, depending on the state’s constitution and statutes. For example, some state officials may have authority to set new coverage requirements for private health plans, Medicaid plans and/or state employee plans; while in other cases, the legislature must set those requirements. Similarly, some state laws provide officials with wide latitude to issue statewide standing orders, while other state laws tightly limit that authority in ways that make it unsuitable for expanding access to OTC contraception. Political and partisan divisions can also act as constraints, if the legislature and governor — and, in some states, an elected insurance commissioner — are not in agreement over their views about contraceptive coverage.

One concern that applies to the full range of potential state actions on OTC contraceptive coverage is the need to educate consumers, pharmacists, insurers and other stakeholders. Some of that education could be broad-based and public, such as through press releases, advertising campaigns and mass media appearances by the governor or other high-level officials. These types of public education can raise general awareness about the state’s policy; help consumers understand the basic process for accessing OTC contraceptives; and head off confusion over how OTC coverage might vary across types of insurance. Stakeholder education could also involve outreach and education for pharmacies, insurance companies and professional associations to help them understand the policy, work out implementation details and provide necessary training for pharmacists and other key staff.

The main attraction of coverage for OTC contraception is its potential simplicity and convenience: A consumer walks into a drugstore, picks up a package of Opill, Plan B or condoms off the shelf, shows their insurance card at the pharmacy counter and leaves the store with their birth control paid for by their insurance plan. To make that work smoothly, state officials, pharmacies and insurance plans will need to streamline and standardize how this all works at the pharmacy.

For example, there needs to be agreement about how to fill out insurance forms, including what to use in place of the usual ID number for the health care provider who writes the prescription. For policy options like pharmacist prescribing, state officials will need to minimize the time that customers and pharmacists need to spend unnecessarily on counseling and health assessments — for example, by making counseling optional, if possible, when the consumer already knows that they want to use a specific OTC contraceptive product.

Another potential complication is that pharmacies will likely need to be part of the consumer’s health insurance network in order for OTC contraceptives to be covered without out-of-pocket costs under any of the models discussed above. And under a pharmacist prescribing model, the individual pharmacist will also need to be in-network — and will need to be compensated by the health plan for time spent on patient counseling and screening. State officials may need to work with health plans and pharmacy chains to make sure that stakeholders understand and appropriately address these potential hurdles.

For strategies that involve coverage under Medicaid plans and state employee plans, state officials may need to take specific action to get Opill and other OTC contraceptive products on the appropriate drug formularies. Officials may also need to set quantity and frequency limits for these OTC products to balance the benefit of obtaining extended supplies with any potential fraud and abuse. It is well documented that a patient’s ability to obtain an extended supply of their contraception leads to significantly better adherence and lower unintended pregnancy rates. About half of the states have policies in place requiring insurance plans to cover an extended supply (most often a 12-month supply) of contraceptives at one time. In these states, the quantity and frequency limits for OTC coverage of contraceptives should be set so that they allow for this extended supply.

In choosing a strategy for improving OTC access, state officials will need to factor in and possibly expand their state’s laws and regulations around health care providers’ allowed scope of practice. For example, they will need to make sure that a state health official has clear authority to issue a standing order (and to renew it periodically, if necessary) and that they are appropriately protected against legal liability for doing so. Policymakers may also need to think about warding off potential backlash from anti-contraception activists and politicians. For example, it may help for the governor to be the face of any new policy, so that career health officials are not exposed to political attacks.

State officials will need to think up front about how to make sure that any new policy strategy on OTC access is implemented correctly and successfully. That begins with gathering information from health plans about their coverage policies and collecting statistics about how many pharmacies are participating, how many consumers are getting their OTC contraceptives covered and other key metrics. Officials may also want to set up telephone or email hotlines for consumers to report problems with OTC coverage. And they might work with researchers and stakeholder groups to identify implementation problems, disparities in consumer access and other issues, and figure out how to address them.

 

States are serving as innovative policy labs to test out promising policy models and to identify potential challenges and complications.

 
 

Governors and other officials in many states have rapidly responded to the opportunity of the first OTC oral contraceptive pill by taking steps to ensure that it is covered by state-regulated insurance plans without a medically unnecessary prescription. As they so often do, states are serving as innovative policy labs to test out promising policy models and to identify potential challenges and complications. Their efforts are laying the groundwork for other states to take action and are building a knowledge base to help the federal government implement a nationwide floor of coverage.

The authors thank Christina Chang, executive director of the Reproductive Freedom Alliance, and Julia Spiegel, founder and CEO of GovAct, for their advice and assistance with this report. Special thanks are due to the numerous officials from states across the country who provided information about their work on OTC contraceptive coverage, including officials from California, Illinois, Massachusetts, New Mexico, New York, North Carolina, Pennsylvania, Washington and Wisconsin.

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 Contraceptive Access Initiative (CAI), is a partner at Keefe Singiser Partners where she largely represents progressive nonprofit 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 watch CAI’s affordability explainer video, see www.thepillotc.org/affordability 

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* A “con” that applies to all of these actions done using executive authority is that a future governor could simply undo the action. State legislative action is more durable, but takes more time. Ultimately, a federal requirement to cover OTC contraception without a prescription would negate the need for states to act.