The Biden administration extended the COVID-19 pandemic public health emergency (PHE) through July 15. The PHE declaration makes possible enhanced Medicaid funding — in exchange for states pausing eligibility redeterminations — and expanded telehealth flexibilities for Medicare and Medicaid beneficiaries. As a condition of receiving enhanced federal funds during the PHE, states are required to ensure continuous Medicaid and CHIP coverage for most enrollees, leading to a nearly 18% jump in Medicaid enrollment. CMS has promised to give states at least 60 days’ notice prior to ending the PHE and 12 months after the month in which the PHE ends to complete eligibility redeterminations. Ultimately, “with the recent rollover of COVID-19 hospitalization activity, we would not be surprised if this is the last extension of the COVID-19-related PHE by the Biden administration,” Citi analyst Jason Cassorla predicted.
Medicare will cover monoclonal antibodies targeting amyloid for Alzheimer’s disease treatment that receive traditional FDA approval under coverage with evidence development (CED), according to an April 7 final National Coverage Determination (NCD). In addition, for drugs that have not shown a clinical benefit or that receive accelerated approval, Medicare will cover them in FDA- or National Institutes of Health-approved trials. CMS will cover the medication and any related services for Medicare beneficiaries participating in these trials. The move follows a proposed NCD released Jan.11, which received more than 10,000 stakeholder comments.
Horizon Blue Cross Blue Shield of New Jersey filed a lawsuit (No. 1:22-cv-10493) against Regeneron Pharmaceuticals Inc. regarding Eylea (aflibercept), a medication approved for certain retinal diseases, including wet (neovascular) age-related macular degeneration. The suit alleges that Regeneron transferred funds to the Chronic Disease Fund, which offset patient out-of-pocket costs for Eylea but not its competitors. The lawsuit argues that this is an illegal kickback under the Racketeer Influenced and Corrupt Organizations (RICO) Act.
Former Centene Corp. CEO and Chairman Michael Neidorff died on April 7, just weeks after he ended his 26-year tenure at the helm of the nation’s largest Medicaid and individual market insurer. Neidorff stepped down from his role leading Centene on Feb. 24 for undisclosed medical reasons, and the insurer’s board appointed a prominent Neidorff deputy, former Optum executive Sarah London, as his successor on March 22. During his marathon tenure, Neidorff transformed Centene from a regional carrier into a publicly traded firm ranked No. 25 on 2021’s Fortune 500. Industry insiders also credit Neidorff with being the first executive to see both Medicaid managed care and the Affordable Care Act exchanges as lucrative businesses.
Just days before the planned start of Anthem, Inc.’s new contract to serve retired New York City workers and their dependents, the city’s comptroller declined to register the proposed contract and turned it back to Mayor Eric Adams (D) for a revised cost estimate. The move effectively freezes the city’s already delayed transition to a group Medicare Advantage contract, which would have nearly doubled the Anthem’s Employer Group Waiver Plan enrollment. “Due to the legal and budgetary uncertainties that remain while litigation over the City’s contract with Anthem Insurance Companies continues, the Comptroller’s office does not have sufficient information to register the proposed Medicare Advantage Plan contract at this time,” New York City Comptroller Brad Lander explained in a March 30 statement posted to the comptroller’s website. Subsequently, the city’s Office of Labor Relations posted that the transition to the NYC Medicare Advantage Plus Plan would not be implemented as of April 1 as planned and that all retirees “will remain in their current plans until further notice.”
The Affordable Care Act (ACA) exchanges have set new records for enrollment, with 14.5 million people enrolling or automatically reenrolling in health insurance during the 2022 open enrollment period, per CMS. New enrollments increased by 2.5 million, or 21%, compared to 2021. Due in part to the enhanced premium subsidies made available as part of the American Rescue Plan Act, the number of enrollees receiving advance premium tax credits (APTC) increased by 2.8 million compared to 2021. According to CMS, the average monthly 2022 premium for HealthCare.gov enrollees was $111. If consumers had not received the additional tax credits, the average monthly premium after APTC for HealthCare.gov consumers would have been 53% higher, or $170, per a press release issued on the ACA’s 12th anniversary. The enhanced APTCs are set to expire at the end of the 2022 plan year, though Congress has considered proposals to make them permanent.
Centene Corp. has named Sarah London as its new CEO after its longtime chief executive, Michael Neidorff, took a medical leave of absence ahead of his planned retirement. London, who was serving as Centene’s vice chairman, will take the helm immediately. In her previous management role, London was responsible for a “portfolio of companies independent of Centene’s health plans, designing differentiated platform capabilities, and delivering industry-leading products and services to third-party customers,” per a March 22 press release. Before coming to Centene, she worked for UnitedHealth Group’s venture capital arm, Optum Ventures, and its data solutions division, Optum Analytics. London’s appointment comes at a time when Centene is planning an overhaul of its PBM assets, with a request for proposal seeking an external vendor due this summer. The firm in recent months has paid millions of dollars to settle accusations by states that its PBM operations overcharged their Medicaid programs for prescription drugs. During Centene’s Feb. 8 conference call to discuss fourth-quarter and full-year financial results, London told analysts that “the strategy here is to outsource administrative PBM functions to an external partner, thereby allowing us to reduce our three PBM platforms down to one and to focus...[on] clinical member and provider engagement.”
Biden administration officials during the annual Healthcare Information and Management Systems Society (HIMSS) Conference said CMS intends to revamp its interoperability regulations. CMS Administrator Chiquita Brooks-LaSure said the Interoperability and Patient Access final rule issued in 2020 “did not quite hit the mark” because it didn’t require standardized application programming interfaces (APIs), FierceHealthcare reported. “Our interoperability rule wasn’t interoperable enough, and it led to many open questions about how data should be exchanged,” she added.
New research from the Kaiser Family Foundation (KFF) indicates that 36% of outpatient mental health and substance use disorder visits were delivered via telehealth in the six months ending in August 2021. Those visits spiked because of flexibilities and social distancing requirements implemented during the peak of the COVID-19 pandemic, KFF concluded.
If shareholders approve, Anthem, Inc. will change its name to Elevance Health Inc. The rebranding is meant to show that Anthem is moving beyond mainly offering health insurance products. “Elevance Health represents who we are today. Powered by industry-leading capabilities and a digital platform for health, Elevance Health’s companies will serve people across the entire care journey, connecting them to the care, support, and resources they need to lead healthy lives,” President and CEO Gail Boudreaux said in a March 10 press release. While Anthem’s affiliate health plans won’t change their names, the company “does expect to streamline the number of other brands in the market.”
Teva Pharmaceuticals Ltd. launched the first generic version of Bristol Myers Squibb unit Celgene Corp.’s Revlimid (lenalidomide) in 5 mg, 10 mg, 15 mg and 25 mg strengths in the United States on March 7. The FDA approved the drug from Teva U.S. affiliate Arrow International Ltd. and Natco Pharma Ltd. on May 21, 2021. The companies have tentative approval for the 2.5 mg and 20 mg strengths due to an exclusivity issue: The FDA has approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide for those dosages. The product is approved for three indications: (1) multiple myeloma in combination with dexamethasone, (2) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities and (3) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib. The launch is limited, and through an agreement with Celgene, the companies are allowed to sell “mid-single-digit percentages” of Revlimid’s total volume this month, a figure that gradually will increase to one-third of the volume. Beginning Jan. 31, 2026, Teva can sell the drug without volume limitation. Multiple companies are expected to launch Revlimid generics in the U.S. this year.
Elixir, Rite Aid Corp.’s PBM business, has joined the Pharmaceutical Care Management Association (PCMA) trade group. According to a March 1 press release, Elixir Chief Operating Officer Chris DuPaul will also serve on the PCMA board of directors. Rite Aid changed the name of its subsidiary EnvisionRxOptions to Elixir in March 2020, saying at the time that the company plans to significantly invest in the rebranded division’s technology platform.