Summary: Recent developments have spotlighted in vitro fertilization (IVF) coverage in Alabama and contraceptive coverage options generally. These developments, along with recent regulatory guidance, have sparked increased interest and inquiries about reproductive health coverage options in employer-sponsored group health plans.
Read on for more information.
In mid-February, three fertility clinics in Alabama suspended vitro fertilization (IVF) services in the wake of a recent Alabama state Supreme Court decision with respect to the legal status of frozen embryos. The Alabama Supreme Court decision held that embryos created through IVF are considered children based on an 1872 state law (known as “the Wrongful Death of a Minor Act"). The case was brought by plaintiffs whose frozen embryos were destroyed at the Alabama hospital storing the embryos.
Alabama Governor Kay Ivey signed legislation on March 6, 2024, shielding doctors and clinics from potential legal liability for providing IVF to patients in the state. As a result, IVF services have resumed in Alabama in at least two of the state’s fertility clinics.
The initial suspension of IVF services in Alabama received a flurry of media attention and garnered questions regarding IVF coverage in other states.
Given the high-profile nature of this state development, many employers sponsoring group health plans might be wondering what this recent Alabama decision could mean for their group health plans in connection with access to IVF and other covered fertility services.
At this point, it appears too early to speculate if access to IVF services outside of Alabama will be impacted. For those employers with employees in Alabama, IVF services have resumed (as noted above).
On the whole, fertility specialty vendors continue to support their clients with employees in Alabama on several fronts including monitoring access to covered network IVF services.
Fully Insured Plans: For fully insured plans, a host of states have passed fertility-related insurance coverage laws, and some include IVF coverage. Click here for the Resolve webpage[1] detailing state-specific fertility coverage information. New Jersey became the most recent state to expand coverage for infertility care, including IVF for groups of more than 50 people, in January 2024.
On the flip side, some states may consider additional regulations or legislation to limit IVF services availability, which could impact access of care for employers sponsoring fully insured plans in those states.
Self-Funded Plans: The impact of these laws and judicial decisions is more nuanced for self-funded plans. While ERISA generally preempts state insurance laws, the Alabama law at issue was a criminal law. Criminal laws aren’t preempted by ERISA unless they narrowly target benefit plans. The Alabama law did not target benefit plans, but IVF providers perceived that the court decision created the risk that they could face criminal prosecution for performing IVF services. This effectively rendered IVF services unavailable (albeit temporarily, as noted earlier) in the state of Alabama. As such, self-funded plans may consider enhancing their travel assistance benefit for employees to access IVF services if they become prohibited (directly or indirectly) in their state(s).
Similar compliance considerations could arise here as those that emerged in the wake of the Dobbs Supreme Court decision in mid-2022, which reversed Roe v. Wade. Click here for a previous Risk Strategies article detailing those compliance concerns.
Employers are advised to consult with their plan carriers or third-party administrator with immediate questions regarding access to IVF services as this landscape continues to evolve rapidly.
Opill, the first over-the-counter (OTC) birth control pill available in the United States (U.S.), will be available in stores and online later this month.
This OTC birth control pill will be available at major retailers and pharmacies, including Walgreens and CVS, and online with a suggested retail price of approximately $20 for a one-month supply and $50 for a three-month supply.
On July 13, 2023 the U.S. Food and Drug Administration (FDA) approved Opill. This approval arrives six decades after daily birth control pills were first introduced in the U.S.
With the FDA approval of Opill, the U.S. joins the ranks of approximately 100 other nations permitting the sale of OTC birth control pills.
Under the Affordable Care Act (ACA), non-grandfathered group health plans must cover women’s preventive services—including birth control—at no cost. However, that requirement only applies to prescription products since plans typically don’t cover OTC drugs and plans may require a prescription for oral contraceptives.
However, the cost related to purchasing Opill at a pharmacy is considered a medical expense[2] which may generally be paid for or reimbursed under employer-sponsored account-based plans such as a health savings account (HSA), health flexible spending arrangement (FSA), Archer medical savings account (Archer MSA) or health reimbursement arrangement (HRA).
On January 22, 2024, the Department of Health and Human Services (HHS), together with the Department of Labor (DOL) and the Department of the Treasury (collectively, the “federal agencies”), released new contraceptive coverage guidance in the form of FAQs.
The federal agencies released these FAQs in response to reports that individuals continue to have difficulty accessing free contraceptive coverage in accordance with the ACA.
As noted above, the ACA guarantees coverage of women’s preventative services, including birth control and contraceptive counseling, at no cost.
This most recent FAQ guidance largely reiterates and reinforces previous contraceptive coverage FAQ guidance released by the federal agencies in July 2022. Click here for a prior Risk Strategies article with more details on the July 2022 contraceptive coverage guidance.
A notable distinction in this most recent FAQ guidance is the inclusion of a new pathway for plans to comply with the ACA’s contraceptive coverage mandate by covering a broader range of FDA-approved contraceptive drugs and certain devices.
This new pathway permits plans to cover all FDA-approved contraceptive drugs and drug-led devices in a specified category (or group of substantially similar products), except those for which there is at least one therapeutic equivalent drug or drug-led device that the plan covers without cost-sharing.
A contraceptive drug or drug-led device is considered “therapeutically equivalent” to another drug or drug-led device if the drug products or drug-led devices are designated as therapeutic equivalents in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the Orange Book).
If plans use this new pathway, they are still required to provide an exceptions process allowing participants to access any medically necessary contraception method without participant cost-sharing.
This exceptions process potentially provides an administrative avenue for Opill (the first OTC birth control pill available in the U.S. as detailed above) to be covered under a group health plan without participant cost-sharing if a plan participant’s doctor determines that Opill is medically appropriate for that individual.
Employers sponsoring group health plans are advised to liaise with their health insurance carriers (for fully insured plans) or their third-party administrators/pharmacy benefit managers (for self-funded plans) to confirm their current contraceptive coverage and ensure that their exceptions process complies with this most recent FAQ guidance.
Finally, on a related development regarding prescription drugs in the reproductive health space, the Supreme Court announced it will hear oral arguments on March 26, 2024 on accessibility to mifepristone, a medication whose primary intent is to aid in medical termination of early pregnancy. Click here for a previous Risk Strategies article with more information regarding recent mifepristone litigation.
Risk Strategies continues to closely watch these developments and remains committed to keeping clients informed.
Contact us directly at benefits@risk-strategies.com.
[1] Resolve is The National Infertility Association, established in 1974.
[2] In accordance with Section 213(d)(1)(A) of the Internal Revenue Code.