CMS Signals Preventive Services Coverage Update With Pending Rule

Changing coverage requirements for a slew of preventive services may be coming to health plans, as CMS eyes an update to Affordable Care Act provisions that may eventually extend to insurance markets beyond the federal and state marketplaces. On August 30, a new proposed rule, Enhancing Coverage of Preventive Services under the Affordable Care Act, was posted to the Office of Management and Budget’s (OMB) dashboard. The release date of the rule remains uncertain, but it may contain new coverage requirements for preventive services such as contraceptive care and vaccines, Richard Hughes IV, health care lawyer with Epstein Becker Green in Washington, D.C., tells AIS Health, a division of MMIT. The appearance of the proposed rule comes as the ACA’s preventive services coverage mandates are entwined in legal proceedings. The Braidwood v. Becerra lawsuit, which focuses on the constitutionality of Section 2713 of the ACA, continues to move through the federal court system. Section 2713 of the ACA requires all non-grandfathered group and individual health plans to offer no-cost coverage of preventive services recommended by the U.S. Preventive Services Task Force, the Advisory Committee on Immunization Practices, and the Health Resources and Services Administration. The Braidwood suit also challenges coverage mandates for specific preventive care on religious freedom grounds. After a decision from the U.S. Court of Appeals for the Fifth Circuit in June failed to resolve the Braidwood suit, the Dept. of Justice (DOJ) is pushing for the Supreme Court to take up the case, according to Hughes. The DOJ’s petition to the Supreme Court is due by Sept. 19, and the case is likely to be considered between that date and the Thanksgiving holiday, he adds. Contraceptive Care, Vaccines May Be at Center One of the bedrocks of the ACA, the roster of no-cost preventive services that insurers must cover provides access to screenings, counseling for mental health and substance abuse, routine vaccinations, and counseling and screening services for pregnant women. The law also covers contraceptive care, as well as treatment for HIV, requiring coverage among all group and individual health plans. Hughes points out that the new proposed rule, which would come with a comment period before the release of a final rule, will be issued solely by CMS. Prior rules addressing ACA-related preventive services, including a 2023 version that fizzled out, have been co-presented by the Dept. of Labor and the Treasury Dept. The fact that CMS is the lone backer “could indicate it is limited in applicability to the marketplace rather than the entire commercial market,” Hughes says, though he adds that the scope of coverage requirements remains unclear. “Maybe CMS is putting it forward and the other agencies will join in,” he says. The 2023 proposed rule that stalled introduced an “individual contraceptive arrangement,” which would have allowed individuals to circumvent their health plan and obtain contraceptive services at no cost-sharing, even if they are enrolled in health plans sponsored by employers that objected to contraceptive coverage. “Without health insurance or other health coverage for or access to contraception at no cost, contraception can be prohibitively expensive, and the cost may deter individuals from obtaining needed care,” CMS stated at the time of the 2023 rule’s release. The agency also said the proposed rule “would create a mechanism, independent from the employer, group health plan, plan sponsor, institution of higher education, or issuer, through which individuals could obtain contraceptive services at no cost from a willing provider of contraceptive services.” While contraceptive care is likely to be an area of focus in the newly posted proposed rule, other coverage areas could emerge as well. Pre-exposure prophylaxis (PrEP), a treatment regimen to prevent HIV, has been a focus for CMS in recent months. In addition to potential coverage updates in the proposed rule, the agency is planning to release a national coverage determination on PrEP treatment by late September. Coverage of PrEP is shifting from Medicare Part D to a Part B benefit. Among other possible targets for CMS, Hughes hopes that the agency will clarify the scope of immunization policies. “The current language is confusing,” he says. The use of the term “routine immunizations” in ACA parlance has muddied the coverage requirements for as long as the ACA has been around, Hughes says. Because the ACA speaks more to “whole groups of people at large” for eligibility criteria, it can miss the “individualized risk factors” that might make more sense for the broad roster of immunizations and screenings. CMS has “a lot of opportunity to improve access, remove barriers and improve clarity,” Hughes says. Other areas that CMS may focus on include access issues such as eligibility for preventive services across settings and the current restrictions on in-network care. Hughes says that he would like to see CMS “eliminate the ‘primary purpose’ and ‘in-network’ requirements that limit access to preventive services.” He argues that doing so would enable more beneficiaries to take advantage of preventive care, such as an individual walking into a neighborhood pharmacy for a seasonal vaccine without having to worry about network status. Also in play are mandatory coverage timelines, which could speed up if CMS chooses to address the adoption period. Hughes, for one, would like to see CMS eliminate the one-year minimum wait period that health plans currently have to cover all required services. Instead, he believes it would be in patients’ best interest to have an immediate coverage policy upon release of any changing preventive service rules. CMS also may take a stab at clarifying “permissible forms of reasonable medical management,” Hughes says. Doing so may ban health plans from relying on utilization management or formulary management that supersedes a provider’s medical decision-making and the patient’s right of choice. To date, just one stakeholder, the American Family Association, has scheduled a meeting with CMS to discuss the proposed rule. Interested parties can schedule an executive order meeting with the agency to provide input on the proposed rule by visiting this website. by Richard Scott