Per a Food and Drug Administration press release,
Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.
The CDC will take up the matter on Wednesday and assuming that CDC approval is given, then health plans will become obligated to cover the full cost of administering the vaccine to this new age group fifteen days later.
The Wall Street Journal adds FAQs:
Do we need to vaccinate children?
Yes, according to most infectious-disease experts. Children can and do get sick from Covid-19, though research shows they typically experience milder cases and are much less likely than adults and the elderly to be hospitalized or die from the virus. As of late March, more than 3.4 million children had been infected with Covid-19, according to the American Academy of Pediatrics, including nearly 14,000 hospitalizations and 279 deaths. The emergence of more-contagious variants, including the B.1.1.7 variant that was first identified in the U.K. and is now dominant in the U.S., appears to be sending younger patients to the hospital with a higher frequency, making vaccines in young adults and adolescents all the more urgent, some doctors and scientists say. In addition, scientists say children need to be vaccinated to achieve the communitywide, or herd, immunity that renders spread of the virus unlikely. “Vaccines give us the opportunity to really turn the tide on this pandemic, and children and teens really need to be a part of that strategy,” said Lisa Costello, a pediatrician and president of the West Virginia chapter of the American Academy of Pediatrics.
Monday continues to be a good day for COVID-19 vaccine news.
In other news —
- Healthcare Dive reports that “Kaiser Permanente generated a profit of $2 billion in the first quarter of 2021, the integrated health system reported Friday, bouncing back from a staggering $1.1 billion loss in the first quarter of last year, largely tied to investment losses amid the stock market slide spurred by the COVID-19 pandemic.”
- The Internal Revenue Service announced 2022 inflation adjustments for (a) minimum deductibles and maximum out of pocket cost sharing in high deductible health plans (“HDHP”) associated with health savings accounts {“HSA”) and (b) maximum health savings account contributions. The Journal of Accountancy explains
The annual limitation on deductions under Sec. 223(b)(2)(A) for an HSA with self-only coverage is $3,650, an increase of $50 over 2021; the corresponding amount for family coverage is $7,300, up $100 from 2021. Sec. 223(b)(3) allows an additional $1,000 annual contribution for individuals age 55 or older before the end of the tax year.
The high-deductible health plan (HDHP) that must accompany an HSA also has inflation adjustments, for its minimum plan deductible amount and its maximum annual out-of-pocket limitation. The deductible for 2022 must be at least $1,400 for self-only and $2,800 for family coverage, both the same as for 2021. The out-of-pocket maximums are $7,050 for self-only coverage and $14,100 for family coverage, increases of $50 and $100, respectively, from 2021.
- The Department of Health and Human Services overruled the Trump Administration’s narrow interpretation of sex discrimination for purposes of the Affordable Care Act’s individual non-discrimination provision known as Section 1557. “Consistent with the Supreme Court’s decision in Bostock and Title IX, beginning today, [HHS’s Office for Civil Rights] will interpret and enforce Section 1557’s prohibition on discrimination on the basis of sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity. This interpretation will guide OCR in processing complaints and conducting investigations, but does not itself determine the outcome in any particular case or set of facts. In enforcing Section 1557, as stated above, OCR will comply with the Religious Freedom Restoration Act, 42 U.S.C. § 2000bb et seq., and all other legal requirements.
- Federal News Network reports that “Few aspects of federal retirement seem to be trending down more than a year after the pandemic first hit the U.S. According to numbers released by the Office of Personnel Management, new claims, processed claims, processing times and the overall claims backlog were all higher in April 2021 than April 2020.”
- Fierce Healthcare informs us that “COVID-19 has only worsened social isolation, but [Blue Cross licensee] Anthem is addressing senior’s loneliness through a “wrap-around” program that encourages them to reach out. Through Member Connect, seniors are assigned a social care partner, who assists with connecting them to community services to address their social needs. They also have a phone pal, a volunteer Anthem associate who reaches out to them weekly. Many members (78%) said they either agreed or strongly agreed that participating in the program led to more meaningful connections with people. In addition, 66% said they are happy or very happy when taking into account all facets of their life in the past seven days.”