Monday Roundup

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From the COVID variant front, David Leonhardt writes in the New York Times as follows:

Covid-19 is once again in retreat.

The reasons remain somewhat unclear, and there is no guarantee that the decline in caseloads will continue. But the turnaround is now large enough — and been going on long enough — to deserve attention.

These declines are consistent with a pattern that regular readers of this newsletter will recognize: Covid’s mysterious two-month cycle. Since the Covid virus began spreading in late 2019, cases have often surged for about two months — sometimes because of a variant, like Delta — and then declined for about two months. * * *

The recent declines, for example, have occurred even as millions of American children have again crowded into school buildings. * * *

I need to emphasize that these declines may not persist. Covid’s two-month cycle is not some kind of iron law of science. * * *

Eventually, immunity will become widespread enough that another wave as large and damaging as the Delta wave will not be possible. “Barring something unexpected,” Dr. Scott Gottlieb, a former F.D.A. commissioner and the author of “Uncontrolled Spread,” a new book on Covid, told me, “I’m of the opinion that this is the last major wave of infection.”

The New York Times reports that

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection.

NBC Boston discusses where the regulators stand in terms of approving a Moderna booster. Moderna submitted its emergency use application on September 1. “Adding to the complexity of further decisions on booster shots, Moderna wants its third dose to be half of the original shots.”

The Food and Drug Administration announced

[issuing] an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.

Today’s authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.

The manufacturer’s press release adds that

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing.

Flowflex COVID-19 tests are already available in many countries outside the U.S., including widespread distribution in the UK through the National Health Service (NHS). The international popularity of this test has led ACON to greatly expand global production capacity at multiple manufacturing sites. This emergency use authorization will now allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

STAT News discusses the pricing considerations for Merck’s pill under development to treat COVID at its symptomatic onset. The article notes

Last June, the U.S. government signed a $1.2 billion deal with Merck for 1.7 million doses, which works out to a $712 unit cost for a five-day treatment course, according to the contract. This assumes the U.S. Food and Drug Administration will authorize emergency use of the pill. Separately, the company has indicated there are plans to produce 10 million doses by the end of this year.

This action suggests to the FEHBlog that Merck can charge a substantially lower price for subsequently manufactured pills.

In today’s column David Leonhardt reminds us that COVID has been a national tragedy, which is unquestionably true in the FEHBlog’s opinion. In that regard, Kaiser Health News explains how COVID deaths have struck rural, black, Hispanic, and Native Americans harder than others which also happens to be the pattern of opioid pandemic deaths as the FEHBlog recalls.

From the COVID regulatory front, the federal departments that regulate the Affordable Care Act and related laws issued ACA FAQ 50. AHIP helpfully explains

The first two FAQs address the recent ACIP and CDC announcements regarding booster doses. The FAQ is intended to notify plans and issuers that the December 12, 2020 ACIP recommendation is the applicable recommendation for purposes of the definition of qualifying coronavirus preventive services under section 3203 of the CARES Act and its implementing regulations.

Plans must cover COVID-19 vaccines and their administration, without cost sharing, immediately once the particular vaccine becomes authorized or approved under an Emergency Use Authorization (EUA) or approved under a Biologics License Application (BLA). This coverage must be provided consistent with the scope of the EUA or BLA for the particular vaccine, including any EUA or BLA amendment, such as to allow for the administration of an additional dose to certain individuals, administration of booster doses, or the expansion of the age demographic for whom the vaccine is authorized or approved.

The prior Q8 in FAQs Part 44 is superseded to the extent it provides that the coverage requirement effective date is related to the vaccine-specific recommendations of ACIP.

In response to stakeholder questions around COVID-19 vaccine incentives and surcharges, the Departments released three FAQs:

Premium discounts for COVID-19 vaccinations are permitted if they comply with applicable wellness program regulations including the requirement to provide a reasonable alternative standard to qualify. The vaccine incentive program must not exceed 30 percent of the total cost of employee-only coverage and must give individuals eligible for the program the opportunity to qualify for the reward under the program at least once per year.

Plans and issuers may not discriminate in eligibility for benefits or coverage based on whether or not an individual obtains a COVID-19 vaccination.

Wellness incentives that relate to the receipt of COVID-19 vaccinations are treated as not earned for purposes of determining whether employer-sponsored health coverage is affordable. However, vaccine surcharges would not be disregarded in assessing affordability.

The FEHBlog had called attention to the 15 day deadline for plans to convert their systems to accomodate the new vaccine. The regulators have removed that grace period which likely reflects COVID reality.

Also, Becker’s Hospital Review informs us that “To clear up a lot of misinformation surrounding COVID-19 vaccines and HIPAA, HHS published guidelines Sept. 30 for employees and employers to better understand the privacy rule.”

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