As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.

The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.

After informing three local plans of its decision to ignore the findings of an administrative law judge (ALJ) and move forward with statewide long-term care contracts awarded to Centene Corp. and UnitedHealth Group, the Arizona Health Care Cost Containment System (AHCCCS) on Sept. 12 in a surprise move extended existing agreements for one year. “Members continue to be the agency’s primary focus throughout this process,” stated AHCCCS, just days after insisting that its procurement process was applied “fairly to all bidders, including the non-awarded health plans.”

In the “Director’s Decision” posted Sept. 9, however, the state Medicaid agency said it was denying the appeals of Mercy Care, Blue Cross Blue Shield of Arizona, and Banner-University Family Care, and it defended its request for proposals (RFP) process, which the ALJ concluded was flawed and should be redone. That was after, according to a statement from AHCCCS, more than one managed care organization “submitted additional information for the Director to consider following the ALJ’s Decision.” AHCCCS said that information was “neither reviewed nor considered in developing the Director’s Decision.”

As insurers await the October release of the 2025 Star Ratings, Chicago-based insurer Zing Health is pursuing a lawsuit stemming from CMS’s calculation of the 2024 Star Ratings, which prompted an unprecedented redo and resubmission of 2025 bids. Based on the third year of poor performance from that initial calculation, CMS in December 2023 informed Zing that it intended to terminate its Medicare Advantage Prescription Drug (MA-PD) contract serving approximately 3,000 enrollees at the end of this year. Although termination was avoided when CMS recalculated the 2024 Star Ratings, the insurer has a few demands of CMS for the “irreparable harm” caused by its initial calculation.

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.

Otezla (apremilast) is available in the U.S. for the treatment of pediatric patients 6 to 17 years of age and weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, Amgen Inc. said Aug. 20. The FDA approved the agent for that use on April 25 while also registering an additional packaging facility to support new packaging configurations for the pediatric population.

Elevance Health, Inc. will offer Affordable Care Act exchange plans in three new states next year. The insurer’s Wellpoint-branded plans will expand into Florida, Maryland and Texas — all states where it has a managed Medicaid presence. According to AIS’s Directory of Health Plans, Elevance Health has approximately 1 million members enrolled in ACA exchange plans, making it the insurer’s smallest market segment. As of 2024, the insurer offered exchange plans in 10 states, with California, Virginia and New York representing its three largest markets.

The value of Affordable Care Act marketplace plans decreased from 2014 to 2023, according to a Paragon Health Institute report published on Sept. 3. The authors — actuaries Daniel Cruz and Greg Fann — noted that just 11% of exchange customers were enrolled in plans with broad provider networks in 2023, down from 36% in 2014. During that same period, gross premiums in the individual marketplace increased 50% more than premiums for people enrolled in employer plans. The authors argued that “the ACA insurance rules caused premiums to increase and led insurers to offer narrower and more restrictive networks over time” and that “the design of the ACA premium tax credits has also incentivized enrollees to select lower-quality plans.”

CVS Health Corp.’s insurance division, Aetna, on Aug. 27 revealed that it became the first major U.S. insurer to update its fertility treatment coverage policy nationally. In what Aetna called a “landmark policy change,” members of eligible plans will now be able to access intrauterine insemination (IUI) as a medical benefit, regardless of their sexual orientation or partner status.

Yet the insurer did not mention in its press release that it agreed to execute a similar policy change as part of a proposed settlement in a case filed by LGBTQ+ enrollees who claimed Aetna’s fertility treatment coverage policies are discriminatory. In fact, Aetna and other insurers are facing several similar lawsuits, says Alison Tanner, senior litigation counsel at National Women’s Law Center (NWLC).

L.A. Care Health Plan and Health Net announced on Aug. 28 they have launched two programs that will collectively invest $90 million over five years to help people experiencing homelessness receive access to care. The health plans will invest $60 million in the L.A. County Field Medicine Program, in which 19 providers will provide coordinated care. They also will invest $30 million in the Skid Row Care Collaborative, which will include harm reduction services, extended hours for urgent care and pharmacies, and onsite specialty medical services in Los Angeles’s Skid Row neighborhood. The programs could assist about 85,000 Los Angeles residents, according to L.A. Care and Health Net, which is a division of Centene Corp.

A federal district judge on Aug. 26 ruled in favor of TennCare beneficiaries who alleged the state’s Medicaid program caused thousands of residents to lose coverage after the introduction in 2019 of an electronic eligibility determination system, Fierce Healthcare reported on Aug. 28. “After years of litigation, plaintiffs have proven TennCare violated their rights under the Medicaid Act, the Due Process Clause of the Fourteenth Amendment, and the Americans with Disabilities Act,” the judge wrote. Fierce noted the state may appeal the court’s ruling. The Tennessee Justice Center, National Health Law Program and National Center for Law and Economic filed the lawsuit in March 2020.

An audit from the HHS Office of Inspector General (OIG) released on Aug. 14 found that MMM Healthcare received an estimated $59 million in net Medicare Advantage overpayments in 2017. Elevance Health, Inc. acquired the Puerto Rico-based MMM in June 2021 when MMM had more than 275,000 MA members and more than 314,000 Medicaid beneficiaries. OIG noted in its report that MMM “did not submit some diagnosis codes to CMS for use in the risk adjustment program in accordance with federal requirements.” Although the insurer received $59 million in overpayments, OIG said it recommended a refund of just $165,312, which was based on a sample of 200 enrollees, “because of federal regulations that limit the use of extrapolation in RADV [Risk Adjustment Data Validation] audits for recovery purposes to payment years 2018 and forward.”

In what whistleblower attorneys say is a novel case, Humana Inc. has agreed to pay $90 million to settle False Claims Act allegations related to the Medicare Part D contracting process. The case was brought by a former employee who alleged Humana engaged in a “reverse-engineering” scheme to submit actuarially equivalent bids to CMS for Prescription Drug Plan (PDP) business that were based on inflated assumptions about the use of preferred pharmacies by low-income subsidy (LIS) members. Humana did not admit wrongdoing and stands by the merit of its assumptions.

The suit, U.S. ex rel. Steven Scott v. Humana Inc. (3:18-CV-00061-GNS-CHL), was originally filed in January 2016 in the U.S. District Court for the Central District of California. It remained under seal until 2017, after the U.S. Dept. of Justice (DOJ) declined to intervene.