Benzinga | Jan 12, 2022 05:33PM EST

Agile Therapeutics CEO Comments On New Gov't. Guidance Reinforcing Requirement To Cover Contraceptives Determined To Be Medically Appropriate For No Cost

On January 10, 2022, the tri-agencies, Department of Labor (DOL), Health and Human Services (HHS) and Treasury issued new guidance that supports women's access to U.S. Food and Drug Administration (FDA) approved contraceptive products. Additionally, on January 11, 2022, the Health Resources and Services Administration (HRSA) updated the Women's Preventative Services Guidelines including contraception services.

In their guidance, the tri-agencies reminded plans and issuers of their responsibility to fully comply with the requirements of the Affordable Care Act and the HRSA Guidelines, including the requirement that, if an individual and their attending provider determine that a particular service or FDA-approved, cleared, or granted contraceptive product is medically appropriate for the individual (whether or not the item or service is identified in the current FDA Birth Control Guide), the plan or issuer must cover that service or product without cost sharing.

They also provided a path for consumers to report concerns if they experience issues obtaining the contraceptive deemed most medically appropriate for them.

The updated HRSA Women's Preventive Services Guidelines, which take effect for plan years beginning 2023, restates the requirement that women have access to the full range of FDA-approved, granted or cleared contraceptives as part of preventative services available without cost sharing.

"Birth control is a very individual decision, and we agree that women should have access to the contraceptive product determined to be most appropriate for them based on discussions with their healthcare provider. The recent guidelines and recommendations will help reduce barriers by providing women with access to the birth control most appropriate for them at no cost." said Kimberly Whelan, Agile Therapeutics Vice President, Policy, Advocacy and Market Access.

Agile Therapeutics Chairman and CEO Al Altomari added, "We agree with the recent recommendations that will help eliminate barriers to contraceptive access for women and we will work with the plans and issuers to achieve this goal."