Thursday Miscellany

Photo by Josh Mills on Unsplash

Today is Earth Day. AHRQ offers “A new AHRQ Views blog post in recognition of Earth Day 2022 highlights the Agency’s emerging efforts to reduce the impacts of climate change.”

From the FEHB front, Fedweek warns federal employees to think hard before rejecting FEHB coverage late in a career. As explained in the article you can lose out on one of the best fringe benefits for federal and postal employees — continuing their FEHB coverage into retirement with the full government contribution.

From the Omicron and siblings front —

STAT News informs us

Experts who advise the CDC met yesterday to discuss a thorny issue: Covid vaccine boosters, specifically the new policy to allow people 50 and older and people who are immunocompromised to get a second booster. By the end of the meeting — during which members of the Advisory Committee on Immunization Practices expressed frustration with the lack of clarity about the goal of the U.S. booster policy — it wasn’t entirely clear why people are being offered a second booster at this time. Data presented by CDC experts suggested the protection that immune-competent people have received from their primary series and first booster is holding up and the expected benefits from the fourth shots are modest at best. ACIP member Beth Bell raised concerns about “booster fatigue” and said offering another dose now could undercut confidence in vaccines that are working well at protecting people from severe Covid. The policy to offer the fourth doses was made without consulting ACIP.

What’s more,

Among the many views expressed around vaccine mandates, one theme persists: the idea that Covid-19 infection protects unvaccinated people against reinfection. While CDC says “getting a Covid-19 vaccination is a safer and more dependable way to build immunity to Covid-19 than getting sick with Covid-19,” a research letter in JAMA Network Open tested the concept of natural immunity by analyzing data from more than 121,000 patients receiving health care in the western U.S. from October 2020 through November 2021, before the Omicron variant took hold. Unvaccinated people who’d been sick with Covid had an 85% lower risk of acquiring Covid again compared to unvaccinated individuals without prior Covid. That level is similar to what mRNA vaccines deliver. Previous infection conferred 88% protection against hospitalization after reinfection and 83% protection against reinfection that did not require hospitalization. The authors conclude natural immunity works as well against both mild and severe illness. One difference: Natural immunity didn’t wane, but mRNA vaccines’ protection did. “This study may have important implications for vaccine policy and public health,” they write.

It is illogical to downplay natural immunity when the worst flu epidemic in U.S. history, the 2018 pandemic, was resolved by a combination of deaths and natural immunity. This is not intended to downplay vaccines. In the FEHBlog’s view, the CDC should be paying more attention to natural immunity from Covid.

From the Covid anti-fraud front, Healthcare Dive reports

The Department of Justice has charged 21 people across the U.S. for pandemic-related healthcare fraud, federal prosecutors said Wednesday.

Defendants — including doctors, medical business executives and fake vaccination card manufacturers — caused nearly $150 million in false billing to federal programs, the DOJ alleged.

The prosecution effort involves some of the “largest and most wide-ranging pandemic-related frauds detected to date,” said Kevin Chambers, the DOJ’s director for COVID-19 fraud enforcement.

From the Food and Drug Administration front —

The American Hospital Association tells us

The Food and Drug Administration seeks comments through June 21 on a potential change that would require outpatient settings to dispense opioid pain medications with prepaid mail-back envelopes and pharmacists to provide patient education on safe disposal of opioids.

“This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events,” the agency said.

Good idea. Also

Health care providers should not use non-invasive prenatal screening tests alone to diagnose genetic abnormalities due to the potential for false results, the Food and Drug Administration warned last week. Also known as cell-free DNA tests or non-invasive prenatal tests, these laboratory developed tests in most cases are not reviewed by the FDA.

“Patients and health care providers should be aware of the risks and limitations of using these genetic prenatal screening tests and that they should not be used alone to diagnose chromosomal (genetic) abnormalities,” FDA said, citing reports that some patients and providers have made critical health care decisions based on the results without additional confirmatory testing. 

From the Rx coverage front, STAT News reports

Thanks to Covid-19 vaccines and therapies, U.S. spending on pharmaceuticals rose 12% in 2021 as use reached record levels and new prescriptions for acute and chronic care largely recovered from the slowdown seen during the pandemic, according to a new analysis.

Meanwhile, out-of-pocket costs paid by patients hit $79 billion, a $4 billion rise from the year before and the same level seen in 2018 after two years of declining costs. Overall, these costs were relatively low — less than $20 per prescription — but about 1% of all prescriptions filled, or 64 million, ran patients $125, underscoring ongoing barriers to affordability. In fact, 81 million prescriptions were not filled last year.

“We’re not in a very different situation from where we were five years ago except for the intensified, competitive market dynamics. But there are no major changes from a major legislative or policy perspective,” said Murray Aitken, senior vice president and executive director of the IQVIA Institute for Human Data Science, which conducted the analysis.

He also noted that the overall use of health services has returned to pre-pandemic levels, but has not yet made up for the backlog in missed patient visits, screenings and diagnostics, elective procedures, and new prescription starts — which IQVIA called a “concerning gap in preventive and treatment services.”

From the opioid epidemic front, the White House announced today

President Biden sent his Administration’s inaugural National Drug Control Strategy to Congress at a time when drug overdoses have taken a heartbreaking toll, claiming 106,854 lives in the most recent 12-month period. The Strategy delivers on the call to action in President Biden’s Unity Agenda through a whole-of-government approach to beat the overdose epidemic.

The Strategy focuses on two critical drivers of the epidemic: untreated addiction and drug trafficking. It instructs federal agencies to prioritize actions that will save lives, get people the care they need, go after drug traffickers’ profits, and make better use of data to guide all these efforts.

Here is a link to the full report