Health Highlights: Dec. 22, 2020
Below are newsworthy items compiled by the HealthDay staff:
FDA Sends Warning Letter to Whole Foods
Undeclared allergens were the leading cause of dozens of recalls by Whole Foods, which "engaged in a pattern of receiving and offering for sale misbranded food products," the U.S. Food and Drug Administration says in a warning letter to the company's co-founder and chief executive officer, John Mackey.
The FDA said it reviewed Whole Foods' history of recalls and found that the company recalled 32 food products due to undeclared allergens between October 2019 and November 2020, Fox Business News reported.
There were similar recall patterns in previous years, according to the agency.
The FDA told Whole Foods it's "responsible" for investigating and determining the causes of each recall, and must take "prompt action" to correct the violations if it hasn't already.
Failure to do so may result in further enforcement, including seizures or injunctions, said the FDA, which gave the company 15 working days to respond.
Whole Foods takes food safety very seriously and is working "closely with the FDA to ensure all practices and procedures" in its stores "meet if not exceed food safety requirements," a Whole Foods Market spokesperson told Fox Business News.
Fauci, Other Top U.S. Health Officials Get COVID-19 Shots
Some top U.S. health officials got their first dose of the Moderna COVID-19 vaccine on Tuesday.
They included Dr. Anthony Fauci, the nation's top infectious disease expert, Health and Human Services Secretary Alex Azar, National Institutes of Health Director Dr. Francis Collins, as well as several NIH Clinical Center frontline health workers, CBS News reported.
After getting his shot, Fauci gave a thumbs-up.
"This, what we're seeing now, is the culmination of years of research which have led to a phenomenon which is truly unprecedented -- and that is to go from the realization that we're dealing with a new pathogen, a virus that was described in January of this year, to less than one year later to have vaccines that are going into the arms of so many people, including myself. And so I consider it an honor to be part of this process," Fauci said, CBS News reported.
The Moderna vaccine received emergency use authorization from the Food and Drug Administration last Friday and the company started delivering doses on Monday. A similar Pfizer-BioNTech vaccine was approved by the FDA a week earlier and distribution began last week.
It's "nothing short of miraculous" to have a safe, effective vaccine in less than a year, according to Azar.
"Americans can be confident in this vaccine and each vaccine the FDA authorizes for COVID-19. These vaccines are going to save so many lives and help bring this pandemic to an end," Azar said.
He added that as "extraordinary as this scientific achievement is, getting this vaccine is more or less just like any other vaccine we receive. We have to follow the right mask wearing and social distancing precautions today, but otherwise, this is just like NIH health care workers or HHS employees getting their annual flu shots."
Americans' Surprise Medical Bills Could Be Reduced by COVID-19 Relief Package
Measures to reduce surprise medical bills for Americans are included in the COVID-19 relief bill passed by Congress.
It's estimated that about 1 in 5 emergency visits and 1 in 6 inpatient admissions lead to surprise bills that can run from hundreds to tens of thousands of dollars, the Associated Press reported.
Under the new rules, the amount patients can be billed for out-of-network services will be limited to a fee based on in-network charges. The amount would count toward patients' in-network annual deductible.
Disagreements between insurers and service providers will be submitted to an independent dispute resolution process, the AP reported.
Patients will be protected from surprise bills related to emergency medical care if they're seen at an out-of-network facility or treated by an out-of-network clinician at an in-network hospital. In both situations, patients' bills would be based on their plan's in-network rate.
Patients admitted to an in-network hospital for a planned procedure are also protected when an out-of-network clinician gets involved. For example, when a surgeon is called in to assist in the procedure, or if the anesthesiologist on duty is not part of the patient's plan, the AP reported.
Out-of-network service providers will generally have to give patients 72-hour notice of their estimated charges. Patients would have to agree to receive out-of-network care to be billed.
Air ambulance services won't be able to send patients surprise bills for more than the in-network cost sharing amount. Ground ambulance services will not face the same restrictions, but the legislation calls for more examination of their billing practices, the AP reported.
The main provisions of the legislation would take effect Jan. 1, 2022.
"This has been a profoundly distressing pocketbook issue for families for years," Karen Pollitz, a health insurance expert with the Kaiser Family Foundation, told the AP. "Some of these bills are onerous, and they all strike people as completely unfair."
EU Approves Pfizer COVID Vaccine
The Pfizer COVID-19 vaccine was approved by the European Union (EU) on Monday and should soon be available in all 27 member nations.
Deliveries of the vaccine are expected to begin this weekend, with shots beginning across the EU between Dec. 27 and Dec. 29, the Associated Press reported.
"As we have promised, this vaccine will be available for all EU countries at the same time, on the same conditions," said European Commission President Ursula von der Leyen. "This is a very good way to end this difficult year, and to finally start turning the page on COVID-19."
The vaccine is already being given to high-risk people in the United States and Britain, the AP reported.
NBA Should be Able to Complete New Season: Commissioner
NBA Commissioner Adam Silver is confident the league can complete its planned 72-game regular season despite the surging coronavirus pandemic.
The league begins play on Tuesday with special health and safety protocols in place, but Silver did say he expects some problems, the Associated Press reported.
"I think we are prepared for isolated cases; in fact, based on what we've seen in the preseason, based on watching other leagues operating outside a bubble, unfortunately, it seems somewhat inevitable," Silver said Monday. "We're prepared for all contingencies."
It's possible that games could be postponed or canceled, and if there are issues that can't be controlled by the health and safety protocols, the season could be suspended, Silver told the AP.
Care Rationing Being Considered by California Hospitals
Plans for rationing lifesaving care are being considered by some hospitals in California as the state struggles with overwhelming numbers of COVID-19 patients.
California has more than twice as many hospitalized COVID-19 patients as it did at its previous peak in July, and models suggest there could be 75,000 patients by mid-January, the Associated Press reported.
In an attempt to deal with the deluge, hospitals are creating makeshift extra beds for COVID-19 patients, and four Los Angeles hospitals are considering what to do if faced with a shortage of beds or staff.
No plans for rationing care are in place, but could be needed because "the worst is yet to come," said Los Angeles County's health services director Dr. Christina Ghaly, the AP reported.