September 06, 2022

The HRSA-Supported Guidelines were initially released in 2019, and provided that:

• Contraceptive care should include contraceptive counseling, initiation of contraceptive use, and follow-up care (e.g., management and evaluation as well as changes to, and removal or discontinuation of, the contraceptive method); and
• Instruction in fertility awareness-based methods, including the lactation amenorrhea method should be provided for women desiring an alternative method.

HRSA updated the Guidelines in 2021 regarding breastfeeding services and supplies, well-woman preventive care visits, access to contraceptives and contraceptive counseling, screening for human immunodeficiency virus, and counseling for sexually transmitted infections. Under the 2021 guidelines, plans and issuers would need to include the updated preventive coverage with no cost-sharing effective January 1, 2023.

Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health (Dobbs) overturning the constitutional right to abortion services, President Biden issued an executive order on July 8, 2022 on protecting access to reproductive health care services. The Departments state that FAQs Part 54 is issued in response to this executive order and following reports of individuals having difficulty accessing contraceptive coverage without cost-sharing.

Overview of FAQs Part 54

Required Reproductive Preventive Care

• Plans and issuers must cover, without cost-sharing, items and services that are integral to the furnishing of a recommended preventive service, which includes contraceptive services under the HRSA-Supported Guidelines (Q/A#1). Examples include anesthesia necessary for a tubal ligation procedure or pregnancy tests needed before provision of certain forms of contraceptives such as intrauterine devices (IUDs), regardless of whether the items and services are billed separately.
• Plans and issuers must cover, without cost-sharing, contraceptive products and services that are not included in a category of contraception outlined in the HRSA-Supported Guidelines (Q/A#2). This coverage must include clinical services, including patient education and counseling, needed for the provision of a contraceptive product or service. The guidance further states that plans and issuers are required to cover, without cost-sharing, contraceptive services products that are not specifically listed in the HRSA-Supported Guidelines if determined by an individual’s provider to be medically necessary.
• The guidance confirms that under 2021 HRSA-Supported Guidelines, plans and issuers are required to cover instruction in fertility awareness-based methods (e.g., lactation amenorrhea) without cost-sharing (Q/A#4).
• The guidance also confirms that plans and issuers are required to cover FDA-approved emergency contraception, including over-the-counter (OTC) emergency contraception and including when the emergency contraception is prescribed by a provider. Although not required, the Departments encourage plans and issuers to cover without cost-sharing OTC emergency contraception that is purchased without a prescription.
• Although the FAQs note this is not required, the Departments encourage plans and issuers to consider covering a 12-month supply of contraception, such as oral contraceptives, without cost-sharing (Q/A#7).

Reasonable Medical Management

• Plans and issuers may use reasonable medical management techniques within a specified category of contraception only to the extent they are not specified by HRSA recommendations or guidelines (Q/A#3), and only if substantially similar services or products that are not included in a HRSA-described category are available and medically appropriate for the individual. The guidance reiterate that plans and issuers must cover without cost-sharing at least one form of contraception in each category described in the HRSA guidelines (or at lease one form in a group of substantially similar services or products).
• The FAQs also state that whether a medical management technique is reasonable depends on the relevant facts and circumstances. The Departments provide examples of unreasonable medical management techniques (Q/A#8), such as:
• Denying coverage for an FDA-approved brand name contraceptive that a provider has deemed medically necessary;
• Requiring an individual to “fail first” using contraceptive products within the same or a different category of contraception before approving coverage for a contraceptive product that is medically necessary; or
• Imposing an age limit on contraceptive coverage

Exceptions Process

• The guidance describes what the Departments will consider to be acceptable exception processes by plans and issuers (Q/A#9). The Departments encourage plans and issuers to develop and utilize a standard form and instructions for the exceptions process, and to make information on an exception process readily accessible electronically (e.g., on a website) and on paper.
• If plans and issuers utilize reasonable medical management techniques, the FAQs state (Q/A#10) that individuals cannot be required to appeal an adverse benefit determination using the plan or issuer’s internal claims and appeals process as the means to obtaining an exception would be unduly burdensome.

Account-based Group Health Plans (HSAs, HRAs, Health FSAs)

• The guidance confirms (Q/A#6) that health savings accounts (HSAs), health reimbursement arrangements (HRAs), and health flexible spending accounts (FSAs) may be used to reimburse the cost (or part of the costs) of OTC contraception obtained without a prescription to the extent the cost is not paid or reimbursed by another plan or coverage. Plans that choose to cover the cost of OTC contraceptives without a prescription should advise plan participants to not seek reimbursement from their account-based plan for the cost (or a portion of the cost) paid or reimbursed by the plan or issuer, and advise participants to not use their HSA, HRA, or health FSA debit cards to purchase contraceptives for which they will seek reimbursement from the plan or issuer.

Preemption and Enforcement

• The FAQs reiterate (Q/A#11) that federal law preempts any state law that would make it impossible to comply with the ACA contraceptive coverage mandate (e.g., a state law prohibiting insurers from covering an FDA-approved, cleared or granted contraceptive product or service).
• The guidance further explains (Q/A#12) that HHS can initiate an investigation if the Department becomes aware that a state may be enforcing a state law that is inconsistent with the ACA’s preventive services requirements, and notes that HHS may assume responsibility for enforcing the contraceptive coverage mandate within that state depending on their investigatory findings.
• The guidance also describes (Q/A#13) the scope of the DOL’s and Centers for Medicare and Medicaid Services’ (CMS) enforcement authorities.

What’s Next?

The ACA’s preventive services requirements – and the coverage of contraception without cost-sharing in particular – is an increasing area of attention and enforcement for employer-sponsored group health plans. Shortly following the Dobbs decision, the Departments sent a letter to employer group health plans and issuers calling for greater compliance with the contraceptive coverage requirements.

At the same time, a new lawsuit has been filed challenging the constitutionality of the ACA’s preventive services requirements. The case, Kelley v. Becerra, is being heard by a federal district court in Texas. At the time of writing, the judge hearing the case has not yet issued a ruling. While additional appeals and litigation is expected regardless of the ruling, employer plan sponsors should be aware of this ongoing challenge. Additionally, HHS is expected to announce a new proposed rule clarifying religious and moral exemptions to the ACA’s preventive care requirements. Business Group on Health will continue to monitor this rulemaking and legal activity and keep members updated on developments.

As the ACA’s preventive services and contraceptive coverage requirements remain in-force, employer plan sponsors should review FAQs Part 54 with legal counsel, TPAs, and health insurance carriers to confirm applicable ACA preventive care services (including contraceptive services and products) are provided without cost-sharing. Employer plan sponsors should also coordinate with their TPAs and health insurance carriers to ensure applicable medical management techniques are compliant with this latest guidance. Plan sponsors that offer HSAs, HRAs, and/or health FSAs may also want to consider reminding plan participants about the interaction between the ACA preventive care requirements and these account-based plans.

Resources

• ACA FAQs Part 54
• Tri-Departments: Press Release – HHS, DOL, and Treasury Issue Guidance Regarding Birth Control Coverage
• Tri-Departments: Letter to Plans and Issuers Regarding Access to Contraceptive Coverage
• White House: Executive Order on Protecting Access to Reproductive Healthcare Services
• ACA FAQs Part 51
• HRSA: Women’s Preventive Services Guidelines

If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.

We provide this material for informational purposes only; it is not a substitute for legal advice.

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Policy & Advocacy Affordable Care Act (ACA)