Oscar Health, Inc. will cease operations in Arkansas and Colorado at the end of this plan year. Chief Financial Officer Scott Blackley defended the decision by saying “they’re really small” markets for the firm in response to a question from Goldman Sachs analyst Nathan Rich during the startup insurer’s latest earnings call, according to the Motley Fool. He added that “they don’t have a significant or even close to material effect [on profits.] There is a benefit though from just reducing…compliance work.” The firm has yet to post a profit, prompting criticism from managed care insiders.
TG Therapeutics, Inc. said April 15 that it voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma. The company said it made the decision based on updated overall survival data from the UNITY-CLL Phase III trial. The company also said that it voluntarily withdrew Ukoniq from sale for two indications: (1) for adults with marginal zone lymphoma who have received at least one anti-CD20-based regimen, and (2) for adults with follicular lymphoma who have received at least three prior systemic therapies. The FDA gave the drug accelerated approval for those indications on Feb. 5, 2021. On Feb. 3, 2022, the company disclosed that the FDA was investigating a possible increased risk of death with Ukoniq based on initial findings from the UNITY clinical trial. The FDA had scheduled an April 22 meeting to discuss the sNDA for the combination therapy, as well as Ukoniq’s accelerated approvals. Following TG Therapeutics’ withdrawal of the BLA/sNDA and Ukoniq’s existing indications, the agency cancelled the meeting. The FDA is expected to make a decision on the BLA for ublituximab in relapsing forms of multiple sclerosis by Sept. 28, 2022.
UnitedHealthcare will restrict access to Aduhelm (aducanumab) across all of its books of business, arguing that “Aduhelm is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to company documents obtained by Stat News. The decision from the insurance branch of UnitedHealth Group, the largest private carrier in the country, follows a controversial move by CMS to restrict access to the drug mainly to patients who are participating in clinical trials. In a National Coverage Determination, CMS said the Medicare program will cover Biogen Inc.’s Aduhelm only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. For Medicare patients to be prescribed Aduhelm, they also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.
As part of its PBM restructuring efforts, Centene Corp. will sell two pharmacy benefits subsidiaries, Magellan Rx and PANTHERx, for approximately $2.8 billion in separate deals. Magellan Rx will be sold to Blue Cross and Blue Shield affiliate-owned PBM Prime Therapeutics for $1.35 billion, while specialty pharmacy PANTHERx will be sold to a group of private equity firms that includes The Vistria Group, General Atlantic and Nautic Partners for $1.45 billion. Both prices are preliminary and the deals must undergo antitrust review. The PANTHERx sale “is expected to close in the next two to four months,” according to a Centene press release, while Magellan Rx “is expected to close in the fourth quarter of 2022.” Centene executives have sought to sell the firm’s PBM assets for some time; new CEO Sarah London said in February that the firm planned to “reduce our three PBM platforms down to one and to focus...[on] clinical member and provider engagement.” After the deals, Centene will retain PBM Envolve Health, presumably to fulfill those functions. Meanwhile, Centene has spent millions to settle claims by state Medicaid programs that it overcharged them for prescription drugs.
News Briefs: New CMS Report Finds Non-White Medicare Advantage Enrollees Continue to Receive Worse Care
A new report looking at disparities in care for Medicare Advantage beneficiaries by race, ethnicity and sex found that non-white MA enrollees generally received worse care in 2020 than their white counterparts. Racial and ethnic differences were more glaring for clinical care measures than for patient experience measures, with scores for Black MA enrollees falling below the national average for 14 out of 36 clinical care measures, according to the April report, which was prepared by The RAND Corp. for the CMS Office of Minority Health. Researchers relied on Consumer Assessment of Healthcare Providers and Systems (CAHPS) data collected from March to May 2021 and the Healthcare Effectiveness Data and Information Set reflecting care received from January to December 2020. White enrollees reported care that was in line with the national average on all patient experience measures from the CAHPS survey, while their scores were similar to the national average on 31 clinical care measures and above average on five measures. Scores for American Indian and Alaska Native MA enrollees were also below the national average on 14 clinical care measures, and scores for Hispanic MA beneficiaries were worse than average on 11 such measures.
CMS on April 28 finalized the 2023 Notice of Benefit and Payment Parameters for Affordable Care Act exchange plans, cementing its proposal to require insurers to offer standardized plans on HealthCare.gov. In a provision opposed by the insurance industry at large, the Biden administration will require issuers offering Qualified Health Plans (QHPs) on the federal exchange to offer standardized plan options at every network type, at every metal level and throughout every service area where non-standardized options are offered, starting in 2023. Those plans also will be differentially displayed on HealthCare.gov “to help consumers make more informed choices about their coverage.” Another major provision included in the annual omnibus rule governing the ACA exchanges is the addition of new network adequacy standards that require QHPs to “ensure that certain classes of providers are available within required time and distance parameters.”
AllianceRx Walgreens Prime — a specialty and home delivery pharmacy business owned by Walgreens Boots Alliance — is rebranding to AllianceRx Walgreens Pharmacy. The move comes after Walgreens assumed full ownership of the business; previously, it was a joint venture between Walgreens and the PBM Prime Therapeutics. In addition to the company’s name change, it promoted Tracey James, R.Ph., from the role of senior vice president to chief operating officer.
Rite Aid Corp. must pay Humana Inc. $123 million after an arbitrator found that the retail pharmacy chain inflated reimbursement claims above the “usual and customary” prices for drugs, Stat reported. Rite Aid’s rival Walgreens Boots Alliance Inc. faces a similar lawsuit brought by several Blue Cross and Blue Shield affiliates. In both cases, the payers allege that the pharmacy chain systematically charged the health plans inflated prices for generic prescription fills. The health plans claim that their contracts with the pharmacies entitled them to reimburse the pharmacies for drug fills at the lowest price that the pharmacies charged for the drug in question, an arrangement called “usual and customary” pricing. However, the health plans say that the pharmacies charged cash-paying customers less than the “usual and customary” price submitted to health plans for reimbursement. Rite Aid plans to ask a federal court to vacate the arbitrator’s decision in the Humana case, per Stat, while the Walgreens-Blues suit is pending.
Humana Inc. will spin off subsidiary Kindred at Home’s hospice and personal care divisions, with private equity fund Clayton, Dubilier & Rice taking majority ownership in exchange for $2.8 billion cash. Humana will retain a minority share in the new hospice company, which the deal values at $3.4 billion. David Causby, president and CEO of the divisions in question, will lead the new firm. “We are excited by the new strategic partnership structure with Humana and look forward to working closely with CD&R to pursue growth,” said Causby.
Former CMS Administrator Leslie Norwalk resigned from Centene Corp.’s board, citing “the governance process surrounding a recent important decision.” Norwalk in her resignation letter said that process “fell egregiously short of what I and a number of other Board members considered appropriate for making an informed decision.” Norwalk added that the board did not debate the move in question. Her resignation comes shortly after the death of longtime CEO Michael Neidorff, whom Sarah London replaced in March.
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.