Friday, January 27, 2023

Axios Vitals: Vaccine changes

Plus, FDA says it can't regulate safety of CBD | Friday, January 27, 2023
 
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Axios Vitals
By Tina Reed · Jan 27, 2023

Happy Friday, Vitals readers. Today's newsletter is 983 words or a 3½-minute read.

Situational awareness: Gay and bisexual men in monogamous relationships will no longer be required to abstain from sex in order to donate blood under proposed changes to federal guidelines, the Washington Post reports.

 
 
1 big thing: States take aim at prior authorization

Illustration: Natalie Peeples/Axios

 

A push to overhaul the prior authorization process is hitting a crescendo in state legislatures, with at least 40 states expected to consider measures that would streamline the way doctors must get a sign-off from health plans before they can order procedures, tests or treatments, Axios' Arielle Dreher reports.

Why it matters: As the nation emerges from the pandemic, officials like Surgeon General Vivek Murthy are blaming administrative burdens like prior authorizations for physician and health worker burnout.

  • The Biden administration in December proposed rules to create an electronic process and shorten wait times for prior authorization in Medicare Advantage, Medicaid managed care, and Affordable Care Act exchange plans.

Driving the news: Clinicians say prior authorization has worsened in recent years, causing delays for patients who need treatments or care, even for chronic conditions that haven't changed in years.

The other side: Health insurers say prior authorization eliminates waste, saves money, and is necessary to ensure patients get the care they actually need.

  • "We believe it's critical to reduce that low-value and inappropriate care," Miranda Motter, vice president of state affairs at AHIP, told Axios. "We recognize that it can be burdensome."

Zoom in: So far, 26 prior authorization bills have been introduced in 16 states, Motter said.

  • Texas passed a law in 2021 allowing clinicians who have 90% of their prior authorization requests for a service or drug approved over six months to earn a "gold card" exempting them from prior authorization for that service.
  • In 2022, Louisiana and Michigan also passed gold-carding legislation, and Mississippi is looking to follow suit.
  • Others like New Jersey are weighing changes to speed up prior authorizations to one day from the current 15 days insurers can take to approve or deny a claim.

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2. FDA panel endorses primary COVID vaccine change

Photo: Sarah Silbiger/Getty Images

 

An FDA expert panel on Thursday unanimously recommended that the U.S. overhaul its pandemic vaccine strategy and replace initial doses of original COVID shots with bivalent ones that target specific Omicron subvariants, Axios' Oriana Gonzalez writes.

The big picture: So far, the U.S. COVID vaccine strategy has been developed and revised on the fly, leading at times to public confusion. With all available vaccines following one single composition, health experts argued that vaccination rates could increase.

  • Currently, monovalent vaccines based on the original COVID strain are still available as the primary series for the unvaccinated. People must then receive bivalent shots as boosters.
  • FDA officials and committee members said during the meeting of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, that there was a need to simplify vaccine composition, adding that the current differences make it harder for people to decide whether to get vaccinated.

What else happened: The FDA had requested that the panel consider a future immunization schedule and proposed a yearly one-dose schedule for the general population and another for "high risk" individuals that would called for at least two doses a year.

  • But the panel did not make a specific recommendation after members said they needed additional data on different population groups and dosage amounts to determine who needs one dose and who needs two.

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3. FDA declines to regulate CBD products
Illustration of a marijuana leaf on a scale

Illustration: Sarah Grillo/Axios

 

The FDA says its current rules for regulating drugs and supplements don't work for determining the safety of CBD products and is calling on Congress to help with a new approach.

What they're saying: "Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives," Woodcock said in the statement.

Why it matters: Walk into many retailers and it's not hard to find products — everything from oils, body lotions, lip balms, soaps, nail polish, makeup and bath bombs to candies, sparkling water and beer — containing CBD.

The big picture: The global cannabidiol market size is expected to top $22 billion by 2030, up from about $5.2 billion in 2021, according to Grand View Research.

  • Yes, but: "Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system," Woodcock's statement read.

The other side: "The FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail," U.S. Hemp Roundtable president Jonathan Miller said in a statement.

What to watch: The House Committee on Oversight and Accountability plans to investigate the decision, officials confirmed. The FDA did not respond to requests for comment.

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4. Data du jour: Drop in reported long COVID
Data: U.S. Census Household Pulse Survey; Chart: Axios Visuals

Among people who have ever had COVID, the share who say they currently or have ever had long COVID declined from 35% in June 2022 to 28% in January 2023, according to an analysis from KFF.

  • The decline was driven by a reduction in the share who currently reported active symptoms, which fell from about 1 in 5 people to about 1 in 10 people, per the analysis of data from the CDC's Household Pulse Survey.

Why it matters: It's a bit of encouraging data in what has been a mysterious, debilitating problem for millions.

  • However, long COVID remains a problem for many. As of Jan. 16, 15% of all adults in the U.S. report having had long COVID symptoms at some point, including 6% who had current symptoms.
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5. Catch up quick

💰 A look inside Medicare Advantage audits that could trigger billions in clawbacks from insurers. (KHN)

🏛 The feds charge dozens in an alleged nursing credential fraud scheme. (Modern Healthcare)

👉 Science journals ban listing of ChatGPT as co-author on papers (The Guardian)

👀 The sudden rise of the "died suddenly" COVID conspiracy theory (The Atlantic)

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6. Dog of the week

Jack. Photo: John and Gina Stephens

 

Meet Jack, a "mischievous" Jack Russell mix who lives in Olney, Maryland, with his humans John and Gina Stephens.

  • "It is amazing how a little guy of 24 pounds can fill a house," they write. "Jack hates being excluded from what he thinks may be a party at home or elsewhere, and will be the first in the car for an adventure." 
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Thanks for reading, and thanks to senior editor Adriel Bettelheim and senior copy editor Bryan McBournie for the edits.

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