By Leila Sullivan and Amy Killelea
In late October, the Departments of Health and Human Services, Labor and Treasury (the “tri-agencies”) published a proposed rule that would expand coverage of preventive services without cost sharing in the commercial market. Specifically, the proposed rule aims to reduce barriers to contraceptive services, including over-the-counter (OTC) contraceptives, and clarify allowable medical management techniques to better ensure consumers receive recommended preventive services without cost-sharing. Group health plans and health insurers would have to provide their enrollees with more choices of covered contraceptives, and for the first time ever, many health insurers and group health plans would be required to cover OTC contraceptives without a prescription or cost sharing. Furthermore, this proposed rule emphasizes the responsibility of plans and insurers to cover birth control methods without cost sharing at a time where many consumers report facing barriers to contraceptive coverage, including step therapy protocols and overly burdensome administrative processes.
In addition to the proposed rule, the tri-agencies also released new guidance for health plans and insurers, aimed at strengthening preventive services protections and increasing plan compliance. Together, the proposed rule and the guidance signal a strong commitment to increasing access to preventive services without cost sharing. However, whether the next Administration will continue this push – particularly given the political discourse surrounding reproductive health – is unclear. Legal challenges to the ACA’s preventive services requirements are also making their way through the courts, with potential to undercut the entire preventive services mandate, including any expansion to OTC coverage.
Background
The Affordable Care Act (ACA) requires group health plans and insurers to provide coverage for preventive services that have been recommended by the United States Preventive Services Task Force (USPSTF), the Health Resources and Services Administration (HRSA), and the Advisory Committee on Immunization Practices (ACIP), without consumer cost sharing. Many of the covered preventive services for women relate to contraception, sterilization procedures, and “patient education and counseling for women with reproductive capacity, as prescribed by a health care provider.”
More than ten years later, the impact of the ACA’s preventive services provision has been dramatic. In 2020, the Assistant Secretary for Planning and Evaluation (ASPE) estimated that almost 152 million people in the United States were enrolled in private health insurance plans covering preventive services with no cost-sharing, and several studies have found that the contraceptive coverage requirement substantially reduced out of pocket (OOP) spending for consumers obtaining contraceptives. Utilization of long-acting reversible contraception (intrauterine devices, arm implants, etc.) has increased, along with short-term birth control methods such as birth control pills and patches. However, the tri-agencies have received complaints that some plans and insurers are failing to provide required coverage. At the same time, since the ACA was enacted, the Food & Drug Administration has approved innovative new contraceptive medications and devices that can help people gain and maintain control over their reproductive health. This, in turn, has prompted the tri-agencies to propose further amended regulations and guidance.
What’s new with the proposed rule?
First, these proposed rules would require plans and insurers to cover recommended OTC contraception without cost sharing or a prescription. Currently, health plans and insurers must cover OTC products without cost sharing when prescribed; this proposed rule would remove the prescription requirement. The tri-agencies cite recent developments in the reproductive health care realm as their reasoning for focusing on contraception, but state that they have not forgotten other preventive services. The tri-agencies are requesting comment on whether to limit the OTC coverage mandate to contraceptives or to apply the policy to all preventive services that have OTC options, including tobacco cessation products and breastfeeding supplies, among others. The Preamble to the rule also raises a number of logistical hurdles that could hinder access to OTC preventive services without cost sharing, including how to ensure that consumers do not have to foot the bill for the OTC product upfront and submit for reimbursement later (as was the case with COVID-19 at-home test kits).
Second, the Departments are proposing that guidance on the use of “reasonable medical management techniques” by insurers be codified, and that these techniques, when used with respect to recommended preventive services, be easily accessible, transparent, and expedient throughout the exceptions process, allowing individuals to use products and services without cost sharing that their provider deems medically necessary for them, even if it is not usually covered by their plan.
Third, these rules would require plans and insurers to disclose that contraceptives are covered without cost sharing, OTC or otherwise, through a self-service tool, and provide a phone number and internet page where enrollees can learn more about the specifics of their coverage.
Billing and coding guidance to increase plan compliance with preventive services mandate
On the same day the tri-agencies released the proposed rule expanding coverage of OTC preventive services, they also released guidance (in the form of Frequently Asked Questions) aimed at improving compliance with the ACA’s preventive services coverage and cost-sharing requirements. The guidance addresses a growing challenge hidden in the billing and coding nuances of how insurance plans determine that a claim is, in fact, preventive. To get paid, providers and labs must submit a set of procedure and diagnosis codes to the insurance plan. The plan then reviews the codes to determine if the service meets coverage requirements, including whether the service qualifies as preventive. This process can get tricky when plans review services that are sometimes covered as preventive (no cost sharing) and sometimes as diagnostic (with cost sharing). For instance, a colonoscopy is considered preventive for people ages 45 years and older and therefore has to be provided free of cost sharing. But for individuals under 45, a colonoscopy is diagnostic and does not have to be covered without cost sharing. Similarly, there are a range of lab services that need to be provided for someone to be prescribed a pre-exposure prophylaxis (PrEP) medication to prevent acquisition of HIV. Those labs (which include sexually transmitted infection and kidney function tests) are free when they are provided as part of a PrEP prescription, but often have cost sharing if they are provided outside of a PrEP prescription. The process by which plans determine when a service is indeed preventive is anything but uniform, which means that many people are getting surprise cost sharing bills for services that should be coded as preventive.
In publishing the FAQ, the tri-agencies recognize and try to correct two related compliance challenges: 1) Providers must code claims correctly for a payer to know if a service is preventive or diagnostic, and 2) payers have variable rules and criteria for determining what constellation of procedure and diagnosis codes will be accepted to adjudicate a claim as preventive with zero cost sharing. The FAQ spells out the obligations plans have to accept industry coding standards that define a service as preventive (e.g., recognizing a modifier appended to a code to flag it as preventive). It also places the onus on a payer to request additional information if it cannot adjudicate a claim as preventive, rather than automatically denying the claim. Finally, the FAQ goes through a number of illustrative examples – including for PrEP, colonoscopies, contraceptives, and mammograms – to indicate the appropriate approach to evaluating claims as preventive.
Conclusion
The proposed rule has the potential to further reduce barriers to access and cost of care for people enrolled in health insurance, and the FAQ is welcome news for consumers who are fed up with getting surprise bills for services they thought would be free. This proposed rule, if finalized, would be the largest expansion of contraception coverage under the ACA since its inception, but only time will tell if this rule and the accompanying guidance will solve the widespread compliance challenges for the ACA preventive services requirements. Furthermore, the political environment surrounding reproductive health and the change in Administration introduce uncertainty into whether the rule will be finalized as written, or at all. However, state regulators can play a role, particularly through oversight of insurers to ensure that plans are complying with these important consumer protections.
Comments on the proposed rule must be submitted by December 27, 2024.
