Happy First Day of Summer 2022

Happy First Day of Summer 2022

Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

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

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

STAT News tells us

Scientists around the world are discovering and tracking newer forms of the Omicron coronavirus variant, showing how even when a strain becomes globally dominant, it continues to evolve and can splinter into different lineages.

Case in point: Updated data released Tuesday showed that a burgeoning form of Omicron, called BA.2.12.1 —  itself a sublineage of the BA.2 branch of Omicron — now accounts for nearly one in five infections in the United States. It’s eating into the prevalence of the ancestral BA.2, highlighting the emergent virus’s transmission advantage over its parent. BA.2 now accounts for about 74% of cases, while the remaining 6% or so are from the BA.1 branch of Omicron, the first form of the variant that took over globally and whose prevalence has been falling as BA.2 became dominant.

The menagerie can be dizzying to track, especially because all these cases technically fall under the Omicron umbrella. But even as scientists closely monitor the divergence of Omicron, early signs suggest the different lineages don’t substantially differ in terms of how virulent they are or in their ability to evade the protection generated by immunizations. While some of the newer forms of the virus might be better spreaders than others, their emergence doesn’t necessarily result in huge increases in cases.

David Leonhardt adds in his New York Times morning column today

In several places where the number of cases has risen in recent weeks, hospitalizations have stayed flat. (In past Covid waves, by contrast, hospitalizations began rising about a week after cases did.) * * *

Even if hospitalizations do rise in coming weeks, a declining share of coronavirus cases that result in serious illness would be very good news, Dr. Craig Spencer, director of global health in emergency medicine at Columbia University, has pointed out.

I haven’t seen a Covid patient in the E.R. in weeks and go to work now expecting not to,” Spencer told me, “despite a swirl of Covid in the community.”

Among other things, a decoupling of cases and severe illness would mean that hospitals were less likely to become overwhelmed during future Covid surges. When hospitals avoid getting swamped, they can provide care to every patient who needs it — which becomes another factor that reduces bad health outcomes.

For these reasons, Mr. Leonhardt plans to shift his focus from new cases to new hospitalizations.

From the Covid vaccine front

Govexec explains

Because mRNA-based vaccines are a relatively new class of vaccines, they do not include the traditional adjuvants. The current mRNA vaccines used in the U.S. rely on small balls of fat called lipid nanoparticles to deliver the mRNA. These lipid molecules can act as adjuvants, but how precisely these molecules affect the long-term immune response remains to be seen. And whether the current COVID-19 vaccines’ failure to trigger strong long-lived antibody response is related to the adjuvants in the existing formulations remains to be explored.

While the current vaccines are highly effective in preventing severe disease, the next phase of vaccine development will need to focus on how to trigger a long-lived antibody response that would last for at least a year, making it likely that COVID-19 vaccines will become an annual shot.

STAT News adds

New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters.

At a hearing of a Food and Drug Administration advisory panel earlier this month, experts fretted about exactly how governments should make decisions about the composition of annual boosters. And they were adamant that governments, not pharmaceutical companies, should be deciding the strain composition of the shots, as the World Health Organization does for influenza shots. But these data are a reminder that those decisions can be tough. What would experts do when faced with booster shots with several different compositions? Will adding new strains work similarly for different types of vaccines? There are a huge number of open questions.

There’s also the biggest problem with annual flu shots: People don’t get them. Even with the current Covid boosters, this has been true. Data presented to the FDA panel said that 217 million Americans are vaccinated about Covid. But only 90 million people have received a booster dose. How many will turn out for a new booster next year?

Look at this comparison of winter 2019-2020 flu vs. 2020-2021 Covid

2019 – 2020 Winter CDC Fluview 3/28/202020-2021 Winter COVID-1910/1/2020 to 3/21/2021
Flu Deaths                       24,000 COVID-19 Deaths               332,636 
Flu Cases             39,000,000 COVID-19 cases        22,399,598 
Deaths over total cases0.06%1.49%

Who would look back on pre-Covid flu as the good old days? But comparatively, it is. We see millions more flu cases, but hundreds of thousands fewer flu deaths.

Kaiser Health News discusses the need for better ventilation in office buildings which could help tamp down Covid and flu cases. “The science is airtight,” said Joseph Allen, director of the Healthy Buildings program at Harvard University’s T.H. Chan School of Public Health. “The evidence is overwhelming.”

From the No Surprises Act front, Healthcare Dive reports

The online portal for resolving payment disputes between payers and providers for certain out-of-network charges is now open, the CMS said Monday. The portal initiates what’s known as the federal independent dispute resolution process, a key part of the No Surprises Act that outlaws balance bills in most cases. As a last resort, it allows payers and providers to resolve payment disputes using an arbitration style similar to the model adopted by Major League Baseball in salary negotiations.

From the transparency in coverage rule front, the Labor Department issued ACA FAQ 53 today. FAQ 53 provides guidance to health plans, including FEHB plans, on how to post three machine-readable pricing files on their website. The Labor Department will begin to enforce this requirement on July 1, 2022.

From the healthcare pricing front

Health Affairs reports

Commercial health plans pay higher prices than public payers for hospital care, which accounts for more than 5 percent of US gross domestic product. Crafting effective policy responses requires monitoring trends and identifying sources of variation. Relying on data from the Healthcare Provider Cost Reporting Information System, we describe how commercial hospital payment rates changed relative to Medicare rates during 2012–19 and how trends differed by hospital referral region (HRR). We found that average commercial-to-Medicare price ratios were relatively stable, but trends varied substantially across HRRs. Among HRRs with high price ratios in 2012, ratios increased by 38 percentage points in regions in the top quartile of growth and decreased by 38 percentage points in regions in the bottom quartile. Our findings suggest that restraining the growth rate of HRR commercial hospital price ratios to the national average during our sample period would have reduced aggregate spending by $39 billion in 2019.

Fierce Healthcare relates

Seniors save nearly $2,000 on average a year in total healthcare spending in Medicare Advantage (MA) compared to fee-for-service Medicare, a new study finds.

The study, published Tuesday, by the advocacy group Better Medicare Alliance finds that seniors spent $1,965 less including premiums and out-of-pocket costs on MA when compared to fee-for-service.

“We see particularly strong results for historically disadvantaged populations, including Black and Hispanic beneficiaries and those who are low-income,” said Allison Rizer, principal at the consulting firm ATI Advisory, which performed the study that examined 2019 Medicare Current Beneficiary Survey data.

From the healthcare business front, Fierce Healthcare tells us

UnitedHealth Group executives said Thursday that its Optum Health subsidiary, which is one of the country’s largest physician groups, is building out value-based care partnerships at a faster rate than was expected.

In its earnings report, the healthcare giant said it initially projected that 500,000 new patients would be treated in value-based arrangements. It’s upping that projection to 600,000. Wyatt Decker, M.D., CEO of Optum Health, said on the company’s earnings call that reflects Optum’s efforts to invest in technology, analytics and building networks are paying off.

“What you’re really seeing is a result of almost 10 years of building a flywheel that now has significant momentum,” Decker said. “All of that continues to yield benefits and, frankly, growth.”

From the research front —

MedPage Today announced

The severity of multiple sclerosis (MS) was linked with geographic latitude, an observational study showed.

Among 46,000 MS patients living in temperate zones, more severe disease was seen in those who lived above 40° latitude, reported Tomas Kalincik, MD, PhD, of the University of Melbourne, Australia, and co-authors.

The association was driven mainly, but not exclusively, by ultraviolet B (UVB) radiation exposure contributing to both MS susceptibility and severity, the researchers wrote in Neurology.

AHRQ discusses a study on “Geographic Variation in Inpatient Stays for Five Leading Substance Use Disorders, 2016-2018.” There are interesting State variations.

Thursday Miscellany

In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.

This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.

The Secretary of Labor who oversees OSHA commented that

“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation. 

“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”

In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:

Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.

The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.

The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.

Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.

In that regard, Bloomberg Law reports that

The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine. 

The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December. 

The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.

Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.

From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”

From the Covid vaccine front, the AP reports that

Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.

As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.

Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.

The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”

Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.

From the telehealth front, STAT News informs us that

A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move  companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.

Execs from companies like Heartbeat Health and Teladoc say they’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story

From the healthcare cost front, STAT News tells us that

— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.

— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.

— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.

From the miscellany department —

  • The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
  • Biopharma Dive considers five questions facing gene therapy in 2022.
  • Fierce Healthcare notes that

As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.

The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.

  • AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.

While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).

  • Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.

Thursday Stats and More

Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s final weekly calendar for 2021 and it’s a stunner:

STAT News features a timely article captioned “Beyond Case Counts: What Omicron is teaching us.”

Brace yourself: Case counts are going to reach astounding heights. Already, reported infections have doubled in just a few weeks. The average daily number of infections is greater than 300,000. (It’s likely that our case counts will become increasingly less reliable as well, given both the shortcomings of our testing infrastructure and the growing use of at-home tests.)  

But, in large part because the immunological landscape today is far different than what it was two years ago, cases are less likely to result in severe disease than was the case at the start of the pandemic. 

Back then, a rise in cases inevitably led to an increase in hospitalizations and deaths. When vaccines went into wide use, those metrics started to become decoupled; cases could rise sharply but hospitalizations and deaths occurred at a lower level than before. In the current phase of the pandemic, the distance between those metrics is growing even greater. * * *

[A] key question relates to how long we’ll be in Omicron’s grasp. South Africa’s bellwether wave soared to extraordinary heights — then quickly began to ebb. Data from several European countries also suggest that Omicron waves may be short, sharp shocks compared to the waves that have preceded it. But too little is yet known to predict with any confidence whether the experience of a country with a relatively young population, such as South Africa, will hold true in a country with an older population, such as the United States. 

Here’s a link to the FEHBlog’s final weekly chart of new COVID deaths:

As cases have skyrocketed, deaths have ranged between 5,000 and 10,000 per week for over four months.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020, when the vaccinations became available to the public, and the 52nd week of 2021:

The number of administered COVID vaccines has dropped during the holidays. Currently, 72.8% of Americans aged 18 and older are fully vaccinated and 36.3% of that cadre are boostered. Nearly 50% of Americans aged 50 and older are boostered.

Also from the COVID vaccine front, the Hill reports that

The Food and Drug Administration (FDA) is expected to approve booster shots of Pfizer and BioNTech’s COVID-19 vaccine for 12- to 15-year-olds on Monday, people familiar with the agency’s plan told The New York Times.

In addition to that broadened policy, the FDA also intends to announce that both children and adults could seek their booster shot five months after their second dose, instead of the previously advised six months. Immunocompromised children ages 5 to 11 are also expected to be allowed boosters, according to the Times.

The Times reported that the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to meet next week to vote on approving the FDA’s policy changes, which CDC Director Rochelle Walensky is expected to endorse. 

From the No Surprises Act front, CMS has released a handy, comprehensive overview of the federal independent review process. Check it out.

From the Affordable Care Act front, Prof. Katie Keith writing in Health Affairs Forefront has released two of three articles on the ACA 2023 Notice of Benefit and Payment Parameters released earlier this week — link to Part 1 and link to Part 2. Part 1 includes a discussion of proposed changes to the medical loss ratio calculation and Part 2 discusses the standardized benefit requirements that the FEHB mentioned earlier this week.

From the health disparity front, the Agency for Healthcare Research and Quality issued its 2021 report on national healthcare qualities and disparities, the nineteen report in this series. Here’s a link to the report’s executive summary.

From the New Year’s Eve front, the New York Times made available this guidance:

“Many public health experts agree that you can celebrate with your favorite people as long as you’re taking precautions.
“To help you make a decision and gauge the level of risk, The Times has this quiz.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports that

The House and Senate are moving swiftly toward passing legislation introduced Tuesday that would limit Senate debate on debt limit legislation to 10 hours, creating a loophole in that chamber’s 60-vote legislative filibuster rules.in his Morning’s column in the New York Times andor a vote Tuesday night, Speaker Nancy Pelosi wrote in a letter to lawmakers, along with a revised fiscal 2022 defense policy bill that would be sent to the Senate separately.

The two legislative vehicles are unrelated bills that previously passed both chambers with amendments; using them to carry the budget and defense measures allows Senate leaders to avoid a time-consuming motion to proceed in that chamber. Instead, only one cloture vote per bill would be needed. 

Senate Minority Leader Mitch McConnell, who briefed his caucus at lunch on Tuesday, blessed the arrangement in comments to reporters. He said the new debt limit measure could pass as early as Thursday, after the Senate clears the bill to create an expedited process.

“I’m confident that this particular procedure coupled with the avoidance of Medicare cuts will achieve enough Republican support to clear the 60 vote threshold,” McConnell said.

If Congress accomplishes all of these actions, it may just call it quits at the end of this week which was the original schedule. A delay in Medicare cuts is extremely important to the medical facility and provider professional associations.

On the COVID vaccine mandate front, a federal district judge in Georgia today ordered a nationwide preliminary injunction against enforcement of the federal government contractor mandate per Govexec which adds

The Biden administration’s vaccine rule for private businesses and vaccine mandate for Medicare- and Medicaid-certified providers and suppliers are also temporarily blocked by courts. So far, the vaccine mandate for federal employees has not been stopped.

This PI applies to all FEHB plan contractors and subcontractors.

From the Delta variant front, David Leonhardt who is the FEHBlog’s go-to COVID columnists recommends in his Morning column in the New York Times today

For now, vaccinated people can reasonably continue to behave as they were — but many should feel urgency about getting booster shots. Older people and others who are vulnerable, like people receiving cancer treatment, should continue to be careful and ask people around them to test frequently.

Unvaccinated people remain at substantial risk of serious illness. About 1,000 Americans have been dying each day of Covid in recent weeks, the vast majority of them unvaccinated.

Look up case and deaths counts for your county here.

From the Rx coverage front, Drug Channels released its

annual deep dive into employer-sponsored coverage for prescription drugs. 

For 2021, employers backed away slightly from high-deductible health plans. However, their pharmacy benefit designs increased the use of coinsurance for specialty and fourth-tier drugs. These designs have significantly raised patients’ out-of-pocket obligations and are likely to have reduced adherence. 

Manufacturers’ patient support funds help offset patients’ higher expenses. But employer plans are rapidly adopting copay accumulators, which allow payers and PBMs to absorb these funds. 

From the health benefits trends front, the Society for Human Resource Management informs us that

Three-quarters of health insurers say that managing a health plan’s network of care providers is critical to controlling rising medical costs.

The finding is from consultancy Willis Towers Watson’s 2022 Global Medical Trends Survey, conducted from July through September 2021 among 209 leading insurers globally.

The plan features mostly likely to keep costs under control, insuers said, were:

— Contracting with high-quality, cost-competitive doctors and hospitals for in-network coverage (cited by 75 percent of respondents).

— Requiring preapproval for scheduled inpatient services (67 percent).

— Offering telehealth services (63 percent).

Telehealth or virtual care rose to the third spot from the fifth position last year, “a sign that more insurers see potential savings from remote options for diagnosing and treating patients,” according to the report.

Yesterday was the deadline for submitting public comments on the the second No Surprises Act interim final rule, which concerns the independent dispute resolution process. For a ying and yang take on the comments, here are links to American Hospital Association’s comments and to AHIP’s comments.

Let’s wrap it up with a bunch of HHS tidbits

  • HHS today announced its plan to “propose a national “Birthing-Friendly” hospital designation on the Hospital Compare section of the CMS Care Compare website, and also encourages states to provide 12 months postpartum coverage to people with Medicaid and CHIP.”
  • The National Institutes of Health reported that “Researchers identified brain cells that help suppress hunger and regulate food intake” and that “The findings may help lead to better treatments for excessive eating and obesity.”
  • NIH also announced “The winners of the National Institutes of Health’s Decoding Maternal Morbidity Data Challenge were announced today in conjunction with the White House “day of action” on maternal health. Twelve prizes were awarded to seven winners who proposed innovative solutions to identify risk factors in first-time pregnancies. Without a prior pregnancy for comparison, it is difficult to identify risks for adverse pregnancy outcomes. Early detection of these risks can help reduce pregnancy complications and prevent maternal deaths.”
  • The Agency for Healthcare Quality and Researched released

A final report on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ. Required by the Patient Safety Act of 2005, the report was made available for public review and comment and review by the National Academy of Medicine. It outlined several strategies to accelerate progress in improving patient safety, including using analytic approaches in patient safety research, measurement, and practice improvement to monitor risk; implementing evidence-based practices into real-world settings through clinically useful tools and infrastructure; encouraging the development of learning health systems that integrate continuous learning and improvement in day-to-day operations; and encouraging the use of patient safety strategies outlined in the National Action Plan by the National Steering Committee for Patient Safety

Access the final report, “Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005” (PDF, 1.16 MB).

  • The Centers for Disease Control “announced today that it has awarded $22 million to nearly 30 organizations around the world to combat antimicrobial resistance (AR) and other healthcare threats through the establishment of two new networks—the Global Action in Healthcare Network (GAIHN) and the Global AR Laboratory and Response Network (Global AR Lab & Response Network).”

Citing mounting evidence of ongoing harm, U.S. Surgeon General Vivek H. Murthy on Tuesday issued a public health advisory on the mental health challenges confronting youth, a rare warning and call to action to address what he called an emerging crisis exacerbated by pandemic hardships.

Symptoms of depression and anxiety have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms, according to Murthy’s 53-page advisory. There also appear to be increases in negative emotions or behaviors such as impulsivity and irritability — associated with conditions such as attention deficit hyperactivity disorder or ADHD.

And, in early 2021, emergency department visits in the United States for suspected suicide attempts were 51% higher for adolescent girls and 4% higher for adolescent boys compared to the same time period in early 2019, according to research cited in the advisory.

Tuesday’s Tidbits

From the Delta variant vaccination and treatment front, AHIP informs us that

The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.

The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.

The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks. 

Acting Food and Drug Commissioner Dr. Janet Woodcock announced

The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

Healthcare Dive informs us that

The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher ScientificQiagen and Lucira Health were quick to claim their tests can detect the emerging variant.    

The Wall Street Journal reports that

The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.

In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”

In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that

On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.

U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges. 

“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”

The New York Times adds

A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week. 

The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.

“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”

The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.

It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.

From the HIV front —

  • The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
  • The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
  • Here is a link to the CDC’s website on HIV treatment.

From the tidbits department —

  • Fierce Healthcare calls to our attention the fact that

The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.

For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.

  • The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
  • AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
  • Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare. 
  • HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.

Friday Stats and More

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the wee, here is the FEHBlog’s weekly chart of new COVID cases this year:

New cases plateaued this week. Weekly new COVID hospitalizations continue their down trend. For the latest week, the number of new admissions was 5,025 compared to a peak of 16,478 in the first week of 2021.

The number of COVID-related deaths continues it decline according the FEHBlog’s chart:

Distribution and administration of COVID vaccines was up sharply the past two weeks. At least one million doses were administered daily last week.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. Notably,

As of November 4, 2021, 426.7 million vaccine doses have been administered. Overall, about 222.6 million people, or 67% of the total U.S. population, have received at least one dose of vaccine. About 193.2 million people, or 58.2% of the total U.S. population, have been fully vaccinated.* About 21.5 million additional/booster doses in fully vaccinated people have been reported. As of November 4, 2021, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 1,510,524, a 55.8% increase from the previous week.

The best news is Pfizer’s announcement of a successful trial of antiviral pill to tame early COVID.

  • PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
  • In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
  • Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

The Merck pill that Great Britain approved this week and the FDA will consider this month had the following reporting efficacy in its trial —

  • At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died

The FEHBlog points this out to illustrate the strength of the Pfizer pill not to downplay the Merck pill.

The public health strategy for defeating COVID always has been a combination of testing, drugs, and vaccines. Nobody expected the vaccines to lead the pack, but the FEHBlog is grateful that testing and drugs finally are catching up to the wonderous vaccines. You combine these new drugs with rapid at home tests like the recently FDA approved FlowFlex on top of the vaccines, and you are left with endemic COVID in the FEHBlog’s view. As the FEHBlog is not a medical expert, let’s close this section with a squib from STAT News:

The development of oral medicines that can be used to treat Covid early on could blunt the impact of the pandemic.

Nahid Bhadelia, the founding director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, called oral antiviral pills “incredibly important” because existing treatments such as monoclonal antibodies must be given intravenously or as shots.

“With an oral antiviral, patients have more time and greater access to a treatment that will keep them out of the hospital,” Bhadelia said. “But the promise of oral antivirals will only be recognized if they’re available at your local pharmacy, and you can afford it, and you can get the test that tells you that you’re positive for Covid, so you can actually take advantage of this drug. So, the promise is there, but the rest of the pieces need to come together.”

From the tidbits department —

Morning Consult reports that

  • 72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
  • 53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.
  • Among the challenges for on-demand telehealth is getting coverage for the services, as traditional payers and providers roll out their own virtual care options.

The HHS Agency for Healthcare Quality and Research reports that

The Lehigh Valley Health Network (LVHN) used an AHRQ initiative to expand treatment for opioid use disorders in Pennsylvania. As a result, primary care physicians are now using medication-assisted treatment to care for their patients with opioid use disorders.  This new practice has been a success; as of fall 2021, 75 percent of patients who initiated treatment have returned in the following calendar month to continue treatment. With addiction treatment, this number of returning patients represents a major improvement, as most patients traditionally end treatment quickly.

With eight hospitals and numerous health centers, physician practices, rehabilitation locations, and other outpatient locations, LVHN serves patients in seven eastern Pennsylvania counties. LVHN used AHRQ resources to integrate treatment for opioid use disorder into primary care practice.

“In one visit, a patient can get his diabetes and blood pressure medications, plus his medication for opioid use disorder, without feeling the judgement of going to an addiction specialist,” noted Gillian A. Beauchamp, M.D., LVHN emergency physician. “When you’re sitting in a primary care waiting room, nobody knows why you’re there, so you don’t feel the stigma you might in another setting of care.”

Bloomberg tells us that

Even though the [COVID pandemic] upheaval increased risk factors for suicide like financial stress, the number of Americans who took their own lives decreased by 3% in 2020, the Centers for Disease Control’s statistical group reported this week

Suicides had increased steadily this century before peaking in 2018 with 48,000 annual deaths. That number declined slightly in 2019 and continued to drop in 2020, to less than 46,000, according to the CDC’s provisional data. In April, when shutdowns were most severe, the U.S. saw the lowest number of suicides in any month of 2020, 14% below the previous year’s total that month.

Federal News Network reports

In an ongoing effort to inject more young talent into the federal workforce, the Office of Personnel Management is out with yet another new hiring policy.

The latest policy, which OPM will publish as an interim rule Friday, is designed to help agencies more easily recruit and hire recent college graduates into administrative and professional positions in the federal government.

The new hiring policy means agencies can noncompetitively appoint qualified and eligible college graduates to permanent career positions at or below the General Schedule 11 level, OPM said. In a blog post on the new policy, OPM Director Kiran Ahuja said recent gradates have a chance to earn up to $72,000 a year under this new authority.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front —

Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:

“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Healthcare Dive tells us that

The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.

Fierce Pharma reports that

Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.

A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.

From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.

From the miscellany front

  • Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.). As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
  • The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.

The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.

Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.

60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.

  • Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”

Tuesday’s Tidbits

Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that “Top House Democrats said the chamber would move forward with voting on the budget blueprint for a $3.5 trillion healthcare, education and climate package next week, rebuffing demands from a group of centrist Democrats to first vote on a $1 trillion infrastructure bill and urging their caucus to stay unified around President Biden’s agenda” According to the article the centrist Democrats opposed the Speaker’s compromise approach discussed in Sunday’s Post and the much larger Democrat progressive causus pushed hard for this outcome. Speaker Pelosi can only afford to lose three of the nine Democrat centrists as the Republicans are expected to unanimously oppose the budget blueprint.

From the Delta variant front

  • Bloomberg reports that the Southern states continue to experience robust vaccination rates one month after the mid-July low point.
  • The Wall Street Journal informs us that “The Delta variant of the Covid-19 virus appears to be breaking through the protection vaccines provide at a higher rate than previous strains, a Wall Street Journal analysis found, though infections among the fully inoculated remain a tiny fraction of overall cases, and symptoms tend to be milder.”
  • Most significantly the New York Times reports tonight that

The Biden administration has decided that most Americans should get a coronavirus booster vaccination eight months after they received their second shot, and could begin offering third shots as early as the third week of September, according to administration officials familiar with the discussions.

Officials are planning to announce the decision on Wednesday at the White House. Their goal is to let Americans who received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the Delta variant, which is causing caseloads to surge across much of the nation. But the new policy will depend on the Food and Drug Administration authorizing additional shots.

Recipients of the Johnson & Johnson vaccine, which was authorized as a one-dose regimen, will also most likely require an additional dose, the officials said. But they are waiting for results, expected this month, from a clinical trial that provided participants with two doses. So far, only about 14 million people in the United States have gotten the Johnson & Johnson shot, which the government began offering in March. The first Pfizer and Moderna vaccines were given in December.

The first boosters would probably go to nursing home residents, health care workers and emergency workers, who were the first to be vaccinated last winter. They would likely be followed by other older people, then by the general population. Officials envision giving people the same vaccine they originally received.

On the federal employment front, Federal News Network tells us that OPM is promulgating an interim final rule that will allow agencies to “hire [bachelors degree or graduate] students to a temporary appointment of a year or a term appointment of one-to-four years. Students will work for their agency at the General Schedule 11 level or below while in school. Students who finish their degrees and meet a series of other requirements are eligible for a permanent position at the same agency, OPM said.”

From the federal guidance front

  • The National Law Review informs us that “OSHA’s Revised COVID-19 Guidance [released August 13] Adopts CDC’s Latest Recommendation on Masks for Vaccinated Employees, Advocates for Vaccination, and Suggests Periodic Testing for Unvaccinated Employees.” “Although OSHA disclaims that its recommendations are legally binding on employers, the agency also includes language that signals that failure to adhere to the recommendations could be legally significant for the employer.  Specifically, OSHA prefaces its guidance by stating: “The recommendations are advisory in nature and informational in content and are intended to assist employers in providing a safe and healthful workplace free from recognized hazards that are causing or likely to cause death or serious physical harm.”
  • The tri-agencies issued Affordable Care Act FAQ 48 informing interested parties that in response to litigation they are working on an amending the “2018 final regulations that expanded exemptions for entities with religious or moral objections to the contraceptive coverage requirement to which their health plans would otherwise be subject.” That rulemaking of course will lead to more litigation and so on.

On the drug news front, STAT News reports that

A new study found that the number of adults who used two widely prescribed stimulants nearly doubled in recent years, raising concerns about a potential wave of abuse since both medicines can be highly addictive.

Specifically, an estimated 4.1 million adults reported using amphetamines and methylphenidate in 2018, an increase of nearly 80% from 2013. Measured by total prescriptions, the use of amphetamines rose 119% during that time, while the use of methylphenidate grew about 39%, according to the study, which was published in BMJ Open.

The article warns that this surge could turn into another epidemic.

On the healthcare utilization front, Fierce Healthcare reports that

Hospitals did not experience a major rebound in deferred care in the first part of 2021, foretelling that such care may not be coming back, a new analysis finds.

The analysis from Kaiser Family Foundation and the Epic Health Research Network, released Tuesday, found hospital spending was 4.1% below expected levels in June. It is the latest evidence of how the lingering impact of the pandemic could affect hospital finances, especially as the highly transmissible delta variant is causing new surges in most states.

“Several factors may be contributing to the lower-than-expected number of hospital admissions in early 2021,” the analysis said. “For example, the economic effects of the pandemic may depress the number of people seeking services.”

Researchers explored data from 250 hospitals across 47 states and 112 million patients through April 9, 2021.

Hospital admission rates were nearly 90% of what were expected if the pandemic did not happen, the analysis found.

From the tidbits department

  • Health Day tells us that “A small, new study suggests that getting out of your chair every half hour may help improve your blood sugar levels and your overall health.”
  • Fierce Healthcare informs us that “New York City-based Unite Us announced this morning [August 17] the acquisition of Carrot Health, a consumer data and predictive analytics platform offering engagement insights to payer and provider customers. With its new purchase, the social determinants of health software platform said it will be better positioned to help healthcare organizations identify patients with unmet social needs and connect them to community resources across all 50 states. Unite Us did not disclose the terms of the deal, which has already closed.”
  • In this week’s NIH Director’s blog, Dr. Francis Collins discusses how advanced brain scanning can help guide neurosurgeons.
  • Last but certainly not least the HHS Agency for Healthcare Quality and Research issued a call to action on achieving health equity.