FDA-Approved Contraceptive Covered With No Out-Of-Pocket Costs to Women

The US Department of Labor and the Health Resources and Services Administration (HRSA) both recently updated their guidance related to contraceptive access for women.

Under the new guidance most insurers and pharmacy benefit managers must provide coverage for US Food and Drug Administration (FDA)-approved contraceptive products prescribed by health care providers including a new hormone-free birth control, Phexxi, with no out-of-pocket costs to women.

"We believe this is a huge step forward toward ensuring contraceptive access for all women at zero copay under the Affordable Care Act (ACA), further reducing unintended pregnancies in the US, and helping women get access to Phexxi, an innovative hormone-free birth control," said Saundra Pelletier, CEO of Evofem Biosciences, in a press release. "We anticipate that millions more women will be able to access Phexxi at no cost—without overly burdensome denials or being forced to try other products first."

The US Department of Labor updates now state:

• “Plans are required to cover an FDA- approved, cleared, or granted contraceptive, if a provider deems it medically necessary, at $0 cost share, whether or not it is specifically identified in the current FDA Birth Control Guide.”

• “Plans may not require patients to try and fail multiple options within a method, or force trying and failing other methods, if a provider deems a product medically necessary.”

The HRSA Women’s Preventive Services Guidelines now state:

• “The full range of FDA- approved, -granted, or -cleared contraceptives, effective family planning practices, and sterilization procedures should be available as part of contraceptive care; and,

• The full range of contraceptives includes those currently listed in the FDA's Birth Control Guide and any additional contraceptives approved, granted, or cleared by the FDA.”

According to Evofem Biosciences, clear communication channels have been established by the Department of Labor for consumers with concerns about their plan’s compliance with HSRA requirements.

Reference:
Phexxi access to expand under new government guidance stating insurers must cover FDA-approved contraceptives with no out-of-pocket costs to women. Evofem Biosciences. January 12, 2022. Accessed January 18, 2022. https://evofem.investorroom.com/2022-01-12-Phexxi-Access-to-Expand-under-New-Government-Guidance-Stating-Insurers-Must-Cover-FDA-approved-Contraceptives-with-No-Out-of-Pocket-Costs-to-Women