From the Delta variant front, Health Magazine informs us that “Former FDA Chief Scott Gottlieb, MD, calls for research into UK Surge of New Delta Plus Variant, AY.4.2 While not yet singled out as a concern in the US, the new Delta subtype prompted a reminder that the world needs ‘robust systems’ to identify up-and-coming threats.” Ruh roh?
The Wall Street Journal reports that
The Food and Drug Administration [FDA] is moving to soon allow people to receive booster shots that are different from their first Covid-19 vaccine doses, people familiar with the matter said.
The FDA won’t recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people familiar with the matter said.
The FDA is seeking to authorize mixing and matching as soon as this week, the people familiar with the matter said. The FDA is also expected to approve Moderna Inc. and Johnson & Johnson boosters this week, according to a person familiar with the matter.
If you find the last sentence somewhat confusing, at this point, only the FDA’s vaccine advisory committee has approved the Moderna and Johnson & Johnson boosters. The acting FDA commissioner Janet Woodcock has to act on that guidance. Once Dr. Woodcock acts then her decision moves to the Centers for Disease Control for its decision.
The FEHBlog noticed today that the Office of Management and Budget’s Office of Information and Regulatory Affairs has held twenty five stakeholder listening sessions so far on the OSHA vaccination screening program rule that will apply to businesses with 100 or more employees. The rule arrived at OIRA last Tuesday October 12. The large number of listening sessions suggests to the FEHBlog that OIRA wants to wrap up its work expeditiously. The OIRA approved rule will be published in the Federal Register.
From the federal employee benefits front, Federal News Network informs us that
The Office of Personnel Management has proposed expanding eligibility for the Federal Employees Dental and Vision Insurance Program (FEDVIP) to include certain temporary and seasonal workers, among others.
OPM will publish a draft rule Tuesday in the Federal Register, which will describe several recommended FEDVIP changes, including new clarifications and provisions designed to make it easier for certain employees to alter their enrollment with the program outside of the traditional open season window.
Federal employees on temporary, seasonal or intermittent schedules — specifically those who work 130 hours a month for at least 90 days — [plus seasonal firefighters] would become eligible to enroll in FEDVIP under OPM’s draft policy.
OPM expanded eligibility for the Federal Employees Health Benefits Program (FEHBP) to this group back in 2014, and the agency’s proposed rule would simply allow temporary and seasonal workers to enroll in FEDVIP as well.
[T]o give [the 86,000] federal and USPS workers on temporary, seasonal and intermittent schedules a chance to enroll for the first time in FEDVIP, OPM envisions giving newly eligible employees a 60-day window after the date that it finalizes this new policy.
The preamble to the proposed rule notes that “As of August 3, 2021, FEDVIP has 5.4 million enrollees with approximately 7.3 million covered individuals.” The FEHB Program’s enrollment is evenly split between 2 million employed enrollees and 2 million retired enrollees plus 4 million eligible family members for a grand total of eight million. The FEHBlog understands why they are more enrollees in FEDVIP because Congress recently added certain TRICARE eligible folks to the FEDVIP program. But why does FEDVIP have the only half the number of eligible family members found in the FEHB Program? Does the FEHB Program offer adequate dental coverage for children? The FEHBlog has never explored that angle.
OPM has bulked up the family member status information and documentation found on its FEHB eligibility website.
From the Rx coverage front, the FDA today approved for marketing “the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses.” Humira is a blockbuster drug which suggests big health system savings from this action. However, STAT News adds that those savings will not be realizable until June 2023 due to a Humira patent settlement. Furthermore
The FDA approved a biosimilar version that will only be available in low-dose concentrations. But three years ago, AbbVie began shifting patients to high-dose concentrations of Humira, which contain fewer excipients that often cause burning and discomfort when the medicine is injected. In fact, high-dose concentrations now account for 80% of the market, according to Bernstein analyst Ronny Gal.
The situation “is not so straightforward,” Evercore ISI analyst Josh Schimmer wrote in an investor note.
In its view, however, Boehringer Ingelheim believes Cyltezo should be considered to have the same “strength” as the corresponding original concentration and high-concentration versions of Humira, because they contain the same total drug content per container.
Nothing is simple when it comes to specialty drugs.
From the benefit design front, STAT News tells us that
The pandemic prompted a mad dash to figure out how to deliver health care virtually. As the dust settles, UnitedHealthcare, the country’s largest insurer, is laying the foundation for the future with a health plan built primarily around telemedicine services designed to be more affordable and accessible.
Called NavigateNOW, the new virtual-first plan will offer care for common services without a copay, including both in-person and virtual primary and behavioral health care, virtual urgent care, and most generic medications. UnitedHealthcare said plan premiums will be about 15% cheaper. The new offering, announced Monday, comes as both legacy insurers and startups are beginning to offer new flavors of health plans that combine conventional and digital services to offer a hybrid kind of care.
NavigateNOW enrollees will have 24-hour access to a virtual health team that includes primary, behavioral, and urgent care through UnitedHealth Group subsidiary Optum, which will also provide in-person care when necessary. Unlike some competitors, United will use its homegrown technology infrastructure to deliver the virtual care.
On a related note Healthcare Dive reports that
Seven months after announcing plans to merge, virtual care company Doctor on Demand and clinical navigator Grand Rounds are launching a new brand for their combined company: Included Health.
The name is meant to stress how the entity offers mental and behavioral healthcare, primary care, chronic care, specialty care, care for LGBTQ individuals and patient navigation tools all under the same roof, Included President Robin Glass and Chief Medical Officer Ian Tong told Healthcare Dive.
The inspiration for the rebrand came from Included Health, a care navigation platform for the LGBTQ community, which Doctor on Demand and Grand Rounds acquired in May in a bid to strengthen their offerings for the underserved population. Included, which covers just under 100 million members, declined to share how much it is investing in the rebrand.