Agile provides update on actions to strength ACA’s no-cost contraceptive rule

Agile Therapeutics provided an update on the actions being taken to strengthen the Affordable Care Act’s no-cost contraceptive coverage requirement. Following several months of focus by the Biden Administration and lawmakers on contraception and reproductive healthcare access barriers, the House Committee on Oversight and Accountability issued a new report addressing the topic: Revised Federal Guidance Regarding Contraceptive Coverage Could Benefit Millions of Women. The report highlights the continued barriers to contraceptive care and inequalities that continue to impact women’s freedom to access the contraceptive that is best for them. The Company commends Rep. Jamie Raskin for his efforts to ensure that women have the healthcare and contraception that they need. Key highlights from the new report include: The report reinforces the urgent need for revisions to federal guidance. By implementing the Committee’s proposed guidance revisions, the Tri-Departments could potentially ensure that 49 million women of reproductive age have increased access to no-cost contraception. The report is a follow-up to, Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private Insurance, in which a House Committee investigation found that insurers and PBMs consistently imposed exclusions or cost-sharing requirements for contraceptive products. The previous investigation resulted in a recommendation that the administration update guidance to address coverage gaps by requiring that all contraceptives without a therapeutic equivalent are covered on plan formularies. This would ensure that all people have access to the most appropriate contraceptive products without out-of-pocket payment, as required by the ACA. This new report follows several recent noteworthy efforts from the Biden Administration and lawmakers to strengthen access to contraception as defined in President Biden’s June 23, 2023, Executive Order: Strengthening Access to Contraceptives. Recent efforts include: After an investigation led by the state finding systemic non-compliance with contraceptive coverage requirements, Vermont Lawmakers requested the Administration provide additional oversight and enforcement of the ACA Contraceptive requirements to ensure health plans and PBMs are following federal and state guidance. In a November 16, 2023, letter4 to the Secretaries of the Departments responsible for implementation of the ACA contraceptive coverage requirements; the Congressional leaders from Vermont, Senators Bernie Sanders and Peter Welch and Representative Becca Balint, requested information from the Departments regarding its efforts to enforce the Affordable Care Act’s no-cost contraceptive coverage requirement. The letter highlighted a recent state investigation that found three insurers in Vermont-BCBS VT, MVP Health Care, and Cigna Healthcare-had failed to provide patients with no-cost contraceptive services in violation of state and federal law and resulted in required restitution of almost $1.5M in inappropriate costs charged to consumers. The Biden Administration convened several meetings to discuss efforts to ensure robust implementation of the President’s Executive Order on Strengthening Access to Contraceptive Care. On October 27, 2023, the White House convened private sector leaders to discuss efforts to ensure access to affordable, high-quality contraception. Administration leaders emphasized the importance of continuing to build on the progress that has been made under the ACA. These efforts include robust implementation of the President’s third Executive Order on reproductive health care access, issued in June 2023, which directed federal agencies to “ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries.” On November 8, 2023, the U.S. Department of Health and Human Services Secretary Xavier Becerra, hosted a roundtable to hear directly from researchers on the ground about barriers to contraception care in the aftermath of the Dobbs Decision, and reaffirm commitment to expanding access to contraception. This roundtable marked the fourth meeting in a series hosted by the Secretary’s Task Force on Reproductive Health. Agile Therapeutics thanks the Administration for its continued efforts and directing the Secretaries to consider actions, to the greatest extent permitted by law, that will ensure coverage of comprehensive contraceptive care including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiarie