News Briefs

CMS is growing increasingly concerned that people, particularly children, are being disenrolled from Medicaid and Children’s Health Insurance Program (CHIP) coverage even though they still meet eligibility requirements. The agency said it sent a letter to officials in all 50 states, Washington, D.C., Puerto Rico and the U.S. Virgin Islands requiring them to determine if they have an eligibility systems issue and, if so, to correct the problem and reinstate coverage to the affected people. Since states were allowed to resume Medicaid redeterminations in April after a multiyear pause due to the COVID-19 pandemic, CMS said it “has learned of additional systems and operational issues affecting multiple states, which may be resulting in eligible individuals being improperly disenrolled. These actions violate federal renewal requirements and must be addressed immediately.”

CVS Health Corp. on Aug. 23 launched a subsidiary called Cordavis, which will work with drug manufacturers to “commercialize and/or co-produce biosimilar products.” CVS said it has contracted with Sandoz to bring Hyrimoz, a Humira biosimiliar, to market in the first quarter of 2024 under a private Cordavis label. The list price of Cordavis Hyrimoz, the company said, will be “more than 80% lower than the current list price of Humira.” Sandoz launched a branded, high-concentration formulation of Hyrimoz on July 1, joining several other Humira biosimilars that launched in the same month.

On Aug. 21, Pfizer Inc.’s Abrysvo became the first vaccine approved by the FDA for use in pregnant people to prevent respiratory syncytial virus (RSV) in infants. The vaccine, which is administered in one dose, is approved for use at 32 through 36 weeks gestational age of pregnancy, and it can prevent lower respiratory tract disease caused by RSV in infants from birth through six months old. In May, the FDA approved Abrysvo for the prevention of lower respiratory tract disease cause by RSV in people age 60 and older. The FDA in July approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) for preventing RSV in infants, and the Centers for Disease Control and Prevention in early August recommended the vaccine be given to all infants under 8 months and some older babies at increased risk of severe illness starting this fall.

Independence Blue Cross has convened a group of hospitals and providers in Pennsylvania and New Jersey that will evaluate 15 clinical decision support tools “that adjust results based on a person’s race, potentially causing delays and inequities in care,” according to an Aug. 10 press release. The companies plan on eliminating the use of race as a variable in some of those tools and discussing alternatives that “do not reinforce a biological understanding of race.” The group is called the Regional Coalition to Eliminate Race-Based Medicine and includes Children’s Hospital of Philadelphia, Doylestown Health, Grand View Health, Jefferson Health, Main Line Health, Nemours Children’s Health, Penn Medicine, Redeemer Health, St. Christopher’s Hospital for Children, Temple Health, Trinity Health Mid-Atlantic and Virtua Health.

Sen. Mike Lee (R-Utah) reintroduced the Biosimilar Red Tape Elimination Act (S. 2305), his office said on July 13. The legislation is focused on increasing competition among biologics and lowering consumer costs for them. He first introduced the bill, which would do away with the FDA requirement for switching studies for biosimilars seeking the interchangeability designation, on Nov. 17, 2022. The legislation has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Clearway Health is working with The Brooklyn Hospital Center to help improve access to specialty pharmacy drugs for underserved patients, Clearway Health said on Aug. 2. The company, which partners with hospitals and health systems to build or improve their own specialty pharmacy programs, said it will help the hospital by broadening its services, decreasing patients’ financial responsibilities, improving patient adherence and boosting clinical outcomes.

In March, the national uninsured rate hit an all-time low of 7.7%, according to new data from the Centers for Disease Control and Prevention. Citi analyst Jason Cassorla wrote in an Aug. 3 investor note that the low rate “is not surprising” since Medicaid continuous enrollment provisions enacted during the pandemic were still in effect at that time – as were enhanced Affordable Care Act marketplace subsidies and the “generally stable to improving employment rate.” However, now that states have been permitted to restart Medicaid eligibility checks, the uninsured rate is almost certain to go back up, he pointed out.

Amazon.com., Inc. is expanding its virtual care offering, Amazon Clinic, to all 50 states and the District of Columbia. “In addition to message-based consultations in 34 states, Amazon Clinic now supports video visits nationwide,” the retail giant said in an Aug. 1 press release. Amazon first rolled out Amazon Clinic last November, but it was not available in all states at that time. Customers using the Amazon Clinic can access services via the Amazon website or mobile app, where they can “compare response times and prices from multiple telehealth provider groups, complete an intake form, and connect with their chosen provider,” the release stated. Patients do not need insurance to access the Amazon Clinic’s services and it doesn’t accept insurance; but the release noted that “medication prescribed by clinicians may be covered by insurance.”

Two Blues affiliates allegedly avoided hundreds of millions of dollars in taxes between 2016 and 2020, a whistleblower said in a complaint filed with the Internal Revenue Service (IRS). Blue Shield of California is alleged to have evaded $111 million in taxes during that period, and Elevance Health's California division allegedly avoided paying $60 million. According to a Stat report, “If the IRS finds Blue Shield violated tax laws, the insurer could owe more than $300 million, an amount that would include the unpaid taxes as well as penalties for committing fraud. Elevance could owe $165 million. If successful, whistleblowers are eligible to receive between 15%-30% of whatever the IRS collects.” The same whistleblower, Michael Johnson, “also filed a similar complaint about Blue Shield in 2018,” per Stat, which the IRS ultimately dismissed.

The Kraft Heinz group has sued Aetna, alleging the insurer “leveraged its role as the third-party administrator or ‘TPA’ to enrich itself to Kraft Heinz’s detriment” and breached its fiduciary duties to the employer. The lawsuit contends that Aetna “(a) paid millions of dollars in provider claims that never should have been paid, (b) wrongfully retained millions of dollars in undisclosed fees, and (c) engaged in claims-processing related misconduct to the detriment of Kraft Heinz,” which contracted with the insurer to provide medical and dental benefits for the company’s employees, retirees and their family members. The firm is asking the court to force Aetna to reimburse it for losses linked to the insurer’s alleged fiduciary breach, along with any related profits.

Blue Cross Blue Shield insurers are again set to collect major payouts from the Affordable Care Act’s risk adjustment program, STAT reported based on an analysis of new federal data. The risk adjustment program transfers funds from ACA marketplace insurers that have lower-risk enrollees to those with higher-risk enrollees. STAT found that more than two dozen Blues insurers are projected to collect over $4.7 billion in risk-adjustment transfers for 2022, with Florida Blue, Health Care Service Corp. and Blue Shield of California due the largest amounts.

On June 30, Blueprint Medicines Corp. revealed that partner Genentech USA, Inc., a member of the Roche Group, will voluntarily withdraw Gavreto’s (pralsetinib) indication for the treatment of people at least 12 years old with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer who require systemic therapy. The FDA gave the indication accelerated approval on Dec. 1, 2020. Genentech said the decision, which was made in consultation with the FDA, was not due to new safety or efficacy data but rather due to the “feasibility” of conducting the Phase III confirmatory trial required for full approval. Confirmatory studies to convert the other indications of the kinase inhibitor, all of which have accelerated approval, to full approval are ongoing.

CMS on July 7 unveiled a long-awaited regulation that would crack down on short-term, limited-duration insurance (STLDI), which some consumer advocates — and the Biden administration — refer to as “junk plans.” Designed to fill a temporary gap in insurance coverage, STLDI plans are exempt from the Affordable Care Act’s rules for comprehensive coverage, allowing them, for example, to deny coverage for preexisting conditions and set lifetime and annual dollar limits on coverage. The Obama administration capped the duration of such plans at three months and limited their renewability, but a 2018 rule from the Trump administration allowed STLDI plans to cover individuals for up to 364 days and be renewed for up to 36 months. If finalized, the Biden administration’s notice of proposed rulemaking would return to the Obama-era three-month limit for SLTDI plans’ initial contract period, and it would set the maximum coverage period at four months, taking into account any renewals or extensions.

As of June 27, at least 1.5 million Medicaid enrollees had lost coverage since eligibility redeterminations started back up, according to the Kaiser Family Foundation (KFF) Medicaid Enrollment and Unwinding Tracker. States have been permitted to restart the process of disenrolling Medicaid beneficiaries since April 1; before that, they were barred from conducting routine eligibility checks and purging their rolls as a condition of receiving enhanced federal matching funds during the COVID-19 public health emergency. KFF noted that there is “wide variation” across the 26 states (plus the District of Columbia) reporting data, with a disenrollment rate as low as 16% in Virginia and as high as 81% in South Carolina. Overall, 73% of people kicked off Medicaid so far in the reporting states have lost coverage due to procedural reasons — like not completing their coverage-renewal paperwork — rather than being deemed ineligible.