HAPPY NEW YEAR!
About Covid-19
FDA authorizes coronavirus vaccine boosters for 12- to 15-year-olds as schools reopen amid omicron surge: “The agency also said everyone at least 12 years old could get a booster dose five months after receiving the second Pfizer-BioNTech shot; previously, boosters were stipulated for six months. And it cleared booster shots for some children ages 5 to 11 who have compromised immune systems.
The FDA actions are expected to be reviewed by the Centers for Disease Control and Prevention and its panel of outside vaccine advisers this week. Assuming the Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday, signs off on the additional shots, CDC director Rochelle Walensky is expected to officially recommend them later that day.”
States report record COVID-19 cases entering 2022: “The United States reported 2.7 million new COVID-19 cases in the week ending with New Year's Eve on Friday, up 105% from the previous week, as the nation has reported a total of 54,771,160 infections and 825,561 coronavirus-related deaths since the start of the pandemic, according to data gathered by Johns Hopkins University.”
CMS releases guidance on healthcare worker vaccination mandate: “CMS has released guidance and survey procedures for the 25 states where its COVID-19 vaccination mandate for healthcare workers is not currently blocked…
The guidance does not apply to 25 states where the mandate is blocked: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming. However it does apply to the remaining 25 states.”
Fauci: CDC mulling COVID test requirement for asymptomatic: “Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant ‘pushback’ on its updated recommendations last week.
Under that Dec. 27 guidance, isolation restrictions for people infected with COVID-19 were shortened from 10 days to five days if they are no longer feeling symptoms or running a fever. After that period, they are asked to spend the following five days wearing a mask when around others.”
Israel now offering fourth covid shot to anyone 60 and older: “Israel on Monday began offering anyone over 60 a chance to get a fourth shot of a coronavirus vaccine, greatly expanding a double-booster effort that previously included just older residents with compromised immune systems and some health-care workers.”
About pharma
Private-equity firm interested in Walgreens' U.K. drugstore chain: “U.S. private equity firm Bain Capital recently approached Walgreens Boots Alliance Inc. about a potential purchase of its U.K. drugstore chain Boots, the Times of London reported, without saying where it got the information.
Bain is positioning itself as a front-runner for an upcoming auction of the unit, the newspaper said. Boots only owns about a quarter of its stores and may be worth 6 billion pounds ($8.1 billion) to 7 billion pounds, according to the report.”
New York PBMs must get licensure, registration under new law: “The legislation — S.3762/A.1396 — signed by Gov. Kathy Hochul Dec. 31, aims to improve transparency surrounding prescription drug costs and establishes a set of duties and obligations PBMs must follow when performing services, according to a news release. It also enables the department of financial services to enforce the law and receive complaints of PBM violations…
PBMs largely operate without regulation, with the bill marking the first such legislation in the country.”
Facebook ad ban may squelch medical research recruitment: “Under fire from critics over its privacy practices, Facebook is implementing a sweeping ban on advertisers targeting patients with messages based on their health conditions. And that could be bad news for drug development.
The decision by the social media giant, which takes effect in January, is part of a broader push to remove ad-targeting options for what it calls ‘sensitive’ topics and is getting measured praise from patient privacy advocates. But critics of the restrictions say the move could have an unintended side effect: Slowing biomedical research by making it harder to use Facebook to recruit people for clinical trials.”
This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020: “The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction.”
This action is one of many that rolled back the Trump administration’s healthcare initiatives.
About diagnostics
When They Warn of Rare Disorders, These Prenatal Tests Are Usually Wrong: This article is an excellent review of for-profit labs that earn significant revenues from performing tests for rare conditions, the results of which are highly inaccurate.
”To evaluate the newer tests, The Times interviewed researchers and then combined data from multiple studies to produce the best estimates available of how well the five most common microdeletion tests perform.
The analysis showed that positive results on those tests are incorrect about 85 percent of the time…
The Times reviewed 17 patient and doctor brochures from eight of the testing companies, including Natera, Labcorp, Quest and smaller competitors. Ten of the brochures never mention that a false positive can happen. Only one mentioned how often each test gets positive results wrong.”
About health insurance
HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule Fact Sheet: “Centers for Medicare & Medicaid Services (CMS) proposed standards for issuers and Marketplaces, as well as requirements for agents, brokers, web brokers, and issuers assisting consumers with enrollment through Marketplaces that use the federal platform.”
The provisions in this proposed rule fact sheet are too numerous to summarize, but the document can be read quickly to get an idea of its contents.