September 26, 2013 — Summary of "Insurance and Access Implications of an Over-the-Counter Switch for a Progestin-Only Pill," McIntosh et al., Perspectives on Sexual and Reproductive Health, September 2013.
Over-the-counter access to a progestin-only oral contraceptive has been proposed as a strategy to reduce unintended pregnancies, but "concerns have been raised that overall access to oral contraceptives may be hindered if such a change negatively affects insurance coverage for other prescription oral contraceptives or creates new barriers to obtaining these products," according to a commentary by Jennifer McIntosh, a visiting research professor at the Hospital Clinic's Department of Pharmacy in Spain, and colleagues.
The authors also note that such a policy "would be unlikely to help women in insurance plans that do not cover [OTC] contraceptives or that require prescriptions for reimbursement." These barriers to access could potentially create "a two-tiered system, in which those who can afford to pay out of pocket have immediate, convenient access to effective contraceptives, while those unable to afford the expenditure are forced to obtain an unnecessary prescription or opt for a less effective [OTC] method," they write.
"To ensure that all women can reap the full benefit of an [OTC] progestin-only pill -- and to make certain that such a pill achieves its ultimate goal of reducing unintended pregnancy by improving contraceptive access for all women -- certain policy and practice barriers need to be addressed before a product is introduced to the market," the authors write.
Justification for a Change in Policy
The authors explain that an OTC oral contraceptive could be "an important option for uninsured women" while also serving "as a critical stopgap for women who run out of pills, forget them when travelling or have a coverage gap while switching insurers." They note that while oral contraceptives are the "leading form of pregnancy prevention" in the U.S., one study found that 28% of women have "experienced difficulties obtaining or filling a prescription for contraceptives," while another "found that running out of pills was a common reason for inconsistent oral contraceptive use."
The authors argue that a progestin-only pill "is an excellent candidate for the first [OTC] oral contraceptives in the United States primarily because it has fewer contraindications than combined oral contraceptives." Progestin-only pills do not contain estrogen -- which has been associated with rare but potentially serious complications, such as stroke and pulmonary embolism -- and women can self-screen for the few contraindications that the pills do have. In addition, the authors note that FDA's prior approval for OTC sales of a progestin-only emergency contraceptive "may make it easier to obtain approval for an [OTC] progestin-only pill than for a combined oral contraceptive product."
However, they note that the "relatively low use" of progestin-only pills -- about 4% of U.S. pill users -- "indicates a need for both provider and patient education if a progestin-only pill becomes available [OTC]."
Insurers Increasingly Offer Coverage for OTC Medications
McIntosh and colleagues note that while insurers have not traditionally covered OTC medications, "[a]n increasing number of private and public insurers now offer some coverage of [OTC] medications, though most require a prescription for reimbursement." A 2010 survey found that 66% of HMOs covered at least some OTC products, up from about 29% in 2000.
The authors note that levonorgestrel EC is "the only hormonal contraceptive pill currently available [OTC], and limited data on private insurance coverage indicate that coverage may vary by state." Twenty-eight states require insurers to cover prescription contraceptives but lack similar requirements for OTC products, according to the authors.
They note that coverage of and access to OTC drugs also varies significantly in government-sponsored programs. For example, a 2007-2008 survey of state Medicaid programs found that two states covered no OTC contraceptives and only 26 of 44 responding states covered OTC EC, compared with nearly all states (46) offering coverage for such products prior to OTC availability. In addition, the survey found that other OTC "contraceptive methods -- spermicide, sponges and condoms -- were covered by Medicaid in 32, 31 and 31 states, respectively."
In addition, the authors note that the Department of Veterans Affairs covers many OTC products, including EC and condoms, but all products "must be prescribed by a VA provider, and all prescriptions must be filled at a VA pharmacy" to qualify for coverage.
The authors add that while both public and private insurers are finally recognizing the benefits of some OTC product coverage, "the fact that this coverage is almost universally tied to a prescription limits the convenience of [OTC] access." Further, the small scale of strategies designed to address these limitations indicates "the need for broader adoptions of similar policies by both public and private insurers," they write.
ACA's Impact on OTC Contraceptive Access
Under the Affordable Care Act (PL 111-148), "group and individual insurance plans created after March 23, 2010, have to cover designated preventive health services as of August 1, 2012, with no cost sharing," including all FDA-approved contraceptive methods "as prescribed," the authors write.
"By requiring coverage and eliminating cost sharing, the ACA promises to improve access to [OTC] methods," but "the fact that a prescription is required may inhibit access to [OTC] contraceptives," they argue.
Additional Contraceptive Access Barriers
The authors outline several other barriers to contraceptive access and potential policy solutions. For example, they suggest that insurers develop and implement new "strategies that allow insurers to track member use while simultaneously facilitating patient access," instead of enforcing prescription requirements that aim to curtail fraud and facilitate billing but also limit patient access. They point to several successful billing mechanisms employed in various states, "illustrating that other private and public insurers could feasibly adopt practices for processing claims without a prescription."
McIntosh and colleagues also note that ACA provisions that allow insurers to apply "'reasonable medical management techniques' to promote the use of less expensive medications" could potentially prevent women from using their first-choice contraceptive method if a progestin-only pill is made available OTC. They note that studies have found these formulary restrictions -- such as preferred drug lists, prior authorization and step-therapy approvals -- can be associated "with delays or interruptions in consumers' medication therapy."
In addition, the authors note that some health plans -- including certain religious employers' plans, grandfathered plans and certain Medicaid plans -- do not have to comply with the ACA's contraceptive coverage rules. They urge clinicians, researchers and advocates to closely monitor the OTC contraceptive access among applicable plans to ensure they meet ACA requirements, while also pursuing efforts to allow states to receive federal reimbursement through Medicaid for OTC contraceptives.
The authors reiterate that plans should be closely monitored for ACA compliance so that women can "reap the full benefits of the legislation." In addition, policies and billing procedures should be developed and implemented "that remove or modify rules that could limit the potential of an [OTC] progestin-only pill to improve contraceptive access and reduce unintended pregnancy for all women," they write.
If a progestin-only pill becomes available OTC, it would be "the most effective contraceptive method ever to become available [OTC] in the United States," the authors write. They conclude, "Working now to pursue a mix of policy-focused and insurer-targeted strategies to get public and private insurance coverage of [OTC] contraceptives, ideally without a prescription, will set the stage for improve access to an [OTC] progestin-only pill in the future."