Mid-week Update

NCQA

Mid-week Update

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, NCQA, NIH, OPM, Rx coverage, U.S. Healthcare–

Following up on this week’s posts

Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.

Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.

This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.

That’s not the case in the FEHB Program. Moreover,

The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.

That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.

From the Omicron and siblings’ front —

The Associated Press reports

The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.

Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *

So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”

The American Hospital Association informs us

The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.

MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”

In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is

Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus. 

From the medical research front —

Healthcare Dive reports

Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.

Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.

It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.

The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.

This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.

Kudos to the winners.

STAT News reports

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.

Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.

From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”

From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.

From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:

Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021

Friday Stats and More

David Ermer–CDC, COVID-19, NCQA, U.S. Healthcare, Uncategorized–

Based on the Centers for Disease Control’s (CDC) Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s 2022 weekly chart of new Covid cases:

The bulge on the left is the first strain of Omicron.

The CDC’s weekly interpretative summary adds,

As of September 14, 2022, the current 7-day moving average of daily new cases (59,856) decreased 15.9% compared with the previous 7-day moving average (71,190). 

CDC Nowcast projections* for the week ending September 17, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five lineages designated as Omicron: BA.5, BA.4.6, BA.4, BF.7, and BA.2.75. UPDATE: BF.7 has been separated from BA.5 and BA.2.75 sublineage is separated from BA.2 due to their positive growth rate. Until last week, these were aggregated with BA.5 and BA.2, respectively. The predominant Omicron lineage is BA.5, projected at 84.8% (95% PI 83.2-86.3%).

Here is the CDC’s chart of daily trends in new Covid hospitalizations:

The CDC’s weekly interpretative summary adds “The current 7-day daily average for September 7–12, 2022, was 4,371. This is a 6.1% decrease from the prior 7-day average (4,657) from August 31–September 6, 2022.”

Here’s the FEHBlog 2022 weekly chart of new Covid deaths

The CDC’s weekly interpretative summary adds, “The current 7-day moving average of new deaths (358) increased 3.9% compared with the previous 7-day moving average (344).”

The American Hospital Association points out that

In-hospital mortality among patients hospitalized primarily for COVID-19 fell from 15.1% during the delta period to 4.9% this April through June, the Centers for Disease Control and Prevention reported this week. 

“In-hospital mortality risk was substantially lower during the later Omicron period overall and for older adults, persons with disabilities, and persons with multiple underlying medical conditions, who accounted for a larger proportion of hospitalizations in this period than they did during previous periods and remained at highest risk for death,” the authors said.

Here’s the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 37th week of 2022. In the 37th week of this year, you will note a noticeable jump in distributions and administrations due to the release of bivalent mRNA booster.

The CDC’s weekly interpretative summary adds,

As of September 14, 2022, 612.8 million vaccine doses have been administered in the United States. Overall, about 263.4 million people, or 79.3% of the total U.S. population, have received at least one dose of vaccine. About 224.6 million people, or 67.7% of the total U.S. population, have been fully vaccinated.

Of those fully vaccinated, about 109.2 million people have received a booster dose,* but 50.0% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

The CDC’s Communities Levels experienced “Compared with last week, * * * a moderate decrease (−3.9 percentage points) in the number of high-level counties, a moderate decrease (-3.8 percentage points) in the number of medium-level counties, and a large increase (+7.4 percentage points) in the number of low-level counties.”

From the unusual viruses front —

  • The AP reports that the CDC warns providers against giving the only monkeypox treatment Tpoxx “to otherwise healthy adults who are not suffering severe symptoms. ‘For most patients with healthy immune systems, supportive care and pain control may be enough,’ agency officials said in a statement.”
  • The New York Times offers information on what parents should know about “the Latest Enterovirus Spike; The C.D.C. has issued an alert [to providers] about enterovirus D68, which has been linked to rare, polio-like paralysis.” In addition, the Times article advises soap and water handwashing and respiratory etiquette.

From the U.S. healthcare business front, we have two articles from Healthcare Dive.

  • “Hospitals are likely to lose “billions of dollars” due to continued depressed margins and heightened labor costs, according to a report Thursday prepared for the American Hospital Association by Kaufman Hall. Even in the report’s optimistic model, more than half of all hospitals could end the year with negative margins, driven by an expected $135 billion increase in expenses this year and an $86 billion rise in labor costs alone.” Here’s a link to the article.

From the medical research front, we have two articles from STAT News:

  • “CAR-T therapy isn’t exclusive to oncology: A half-dozen people with severe lupus, an autoimmune condition, have gone into remission after receiving an infusion of CAR-T cells, STAT’s Isabella Cueto reports. In lupus, B cells create antibodies against a person’s body, resulting in a vicious cycle of inflammation and immune attacks that lead to pain, fatigue, and organ damage. * * * Although the treatment has only been tested in six patients thus far, experts agree it is tantalizing.”
  • “There hasn’t been much in the pharmaceutical arsenal to help people who abuse methamphetamines. But STAT’s Lev Facher reports that researchers are now studying a new monoclonal antibody, which binds to meth molecules and helps prevent them from entering the brain. The antibody is showing early promise in the smattering of emergency rooms involved in the study. One Phase 2 study is testing if the monoclonal antibody can treat meth overdose, and another is measuring its efficacy in helping long-term recovery. Ideally, the drug could be used for both purposes. The drug’s development is overseen by the University of Arkansas for Medical Sciences and the biotech InterveXion.”

From the miscellany front

  • WTW released a study on how large employers are “doubling down on controlling healthcare costs and enhancing affordability.
  • The National Committee for Quality Assurance released its Measurement Year 2021 health plan ratings.
  • RevCycle Intelligence offers an interesting angle on a Health Affairs study of the efficacy of State No Surprise Billing laws in controlling out-of-network spending.

Midweek Update

David Ermer–CDC, COVID-19, Employee Wellness Programs, Federal employment benefits, NCQA, OPM, SDOH, Telehealth, U.S. Healthcare–
Photo by Mel on Unsplash

From the Omicron and siblings front

The Wall Street Journal reports

The seven-day moving average of new Covid-19 cases recently topped 94,000 a day, Centers for Disease Control and Prevention data show, nearly four times lows reached in late March. The true number of new cases is likely significantly higher, epidemiologists say, because so many people are self-testing at home or not testing at all. 

The rise in cases hasn’t translated thus far into major surges in severe illness. The seven-day average of confirmed cases in hospitalized patients reached about 18,550 on Wednesday, up from lows near 10,000 in mid-April, but far below a record peak above 150,000 in January. The numbers include people who test positive on routine screening after getting hospitalized for other reasons. The daily average of reported deaths has slipped under 300 a day, the lowest point since last summer.

But * * * the more an outbreak spreads, the more likely it will reach the most vulnerable including elderly people and others with compromised immune systems, the experts say, and the more likely the virus will continue to mutate.

Bloomberg Prognosis adds

As Covid-19 again surges across the US, many people are going without time-sensitive therapeutics like Paxlovid because doctors worried about shortages are reluctant to prescribe the drugs. But the situation has changed and supplies are now abundant.

The Food and Drug Administration has issued emergency-use authorizations for the drug to treat mild to moderate Covid-19 in people who are at high risk. The Centers for Disease Control and Prevention defines those as individuals ages 50 years or older, unvaccinated, or with certain medical conditions like kidney, liver, lung and heart disease, diabetes, cancer and HIV. It also recommends the drug for people who are immunocompromised, pregnant, obese, cigarette smokers or suffering from mood disorders.

You can find the one stop test to treat locations “by using the Department of Health and Human Services’ Test to Treat Locator or by calling 1-800-232-0233.”

Kaiser Health News recommends “improving ventilation and filtration of the air. ‘Ventilation matters a lot,’ said Dr. Amy Barczak, an assistant professor of medicine at Harvard Medical School. ‘If you’re taking care of someone at home, it’s really important to maximize all the interventions that work.’”

Viral particles float through the air like invisible secondhand smoke, diffusing as they travel. Outside the home, viruses are quickly dispersed by the wind. Inside, germs can build up, like clouds of thick cigarette smoke, increasing the risk of inhaling the virus.

The best strategy for avoiding the virus is to make your indoor environment as much like the outdoors as possible.

In related viral news, Beckers Hospital Review tells us

More than 400 children worldwide have developed unusual cases of acute hepatitis, and researchers are still searching for the cause of the outbreak, the World Health Organization said May 17.  

As of May 15, the WHO reported 429 probable cases in 22 countries, up from 348 cases a week prior, according to Philippa Easterbrook, MD, a senior scientist in the global hepatitis program at the WHO. Another 40 cases are still under investigation, and 75 percent of all affected children are under age 5. 

Twelve countries are reporting more than five cases, double the amount from last week. Of these 12 countries, nine are in Europe. In total, six children have died in the outbreak and 26 have required liver transplants, according to Dr. Easterbrook. 

As of May 17, researchers were still investigating the cause of the hepatitis outbreak. The leading hypothesis is that an adenovirus and SARS-CoV-2, the virus that causes COVID-19, may be causing hepatitis in children. Scientists are exploring “how these two infections may be working together as co-factors either by enhancing susceptibility or creating an abnormal response,” Dr. Easterbrook said. 

From the healthcare policy front, AHIP today launched

Healthier People through Healthier Markets, a new policy roadmap and set of solutions to improve health care affordability and access for every American. The effort is focused on boosting competition in health care markets and reining in harmful practices that hurt American families. With the launch of this policy roadmap, AHIP sent letters to President Biden and the leadership of Congress that lay out a detailed set of legislative and regulatory enforcement actions to increase competition in health care, drive down costs, and improve health care access for patients.

The FEHBlog supports this approach.

From the mental healthcare front, Govexec reports

The Office of Personnel Management on Wednesday urged federal agencies to ensure their employees are aware and can access the mental health benefits provided to federal workers, in light of May being Mental Health Awareness Month.

In a memo to agency heads, OPM Director Kiran Ahuja noted that promoting the federal workforce’s wellbeing, including mental health, is a priority in President Biden’s management agenda.

“We want to make sure that all federal employees understand the supports available to them and underscore that there should be no shame or stigma for taking care of their mental health,” Ahuja wrote. “[As] a reminder, employee assistance programs and Federal Employees Health Benefits health plans offer mental health services to employees and their family members. We encourage agencies to proactively communicate to their workforces about their options and encourage employees to contact their agency benefits officers or EAP coordinator to learn more.”

The FEHBlog encourages OPM to better coordinate mental health care services among FEHB plans, EAPs and wellness programs.

From the telehealth front

  • mHealth Intelligence informs us “In the second half of 2020, only 14.1 percent of children used telehealth due to the pandemic, but use was higher among those with asthma, a developmental condition, or a disability, the Centers for Disease Control and Prevention (CDC) found.”

From the survey department, Beckers Payer Issues advises that “Castlight Health analyzed more than 160 million commercial medical claims nationwide to reveal insights about healthcare utilization patterns from 2018 to 2021.” Castlights report ranks the fifty States and DC based on average medical spending per member in 2021.  

From the miscellany department —

  • Beckers Payer Issues reports “Anthem shareholders voted at their annual meeting May 18 to change the company’s name to Elevance Health.”
  • Federal News Network discusses the Postmaster General’s plans to close and consolidate Postal facilities across the delivery network. “The network transformation initiative will impact nearly 500 network mail processing locations, 1,000 transfer hubs and 100,000 carrier routes. It will also impact 10,000 delivery units, which USPS defines as post offices, stations, branches or carrier annexes that handle mail delivery functions.”
  • FedSmith tells us “Starting May 26, 2022, federal retirees will notice a new process for signing into the OPM Retirement Services Online website. The login process will now be managed through the federal government’s Login.gov website and will require you to create a new username and password at login.gov if you do not currently have one.”

Midweek update

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, NCQA, OPM, Rx coverage, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

From the Omicron and siblings front

The American Hospital Association informs us

COVID-19 vaccinations prevented an estimated 107,000 Medicare hospitalizations between January and May 2021, resulting in $2.6 billion in savings for Medicare and Medicare Advantage plans, according to a new report by the Department of Health and Human Services. The report estimates the impact of COVID-19 vaccination during a five-month period shortly after the first vaccine was authorized and recommended for health care workers and elderly people in long-term care facilities. Future analyses will examine hospitalizations prevented by vaccination during the delta and omicron waves, HHS said.

Bloomberg Prognosis tells us

Pfizer Inc. executives said patients who suffer a relapse in Covid-19 symptoms after taking a full course of Paxlovid should take more of the treatment, though current U.S. guidelines limit use to five consecutive days.

“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.

In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.”

As noted in the article, the fly in the ointment is that the FDA emergency use authorization does not expressly approve a second course of the medication.

From the Rx coverage front

MedCity News reports on Bristol Myers Squibb’s (BMS) NEX-T program to improve CAR-T treatments.

The company has described NEX-T as changes to manufacturing driven by the translational insights it has gleaned from treating thousands of patients with its CAR T therapies. In addition to a faster turnaround time, the strategy is intended to reduce the costs of the overall process.

One of the key goals for the next-generation of cell therapies is treating solid tumors.

Another strategy that BMS is pursuing is going after two targets with a single therapy, reducing the risk that a tumor escapes from the treatment

Looking at the flip side of this coin, Forbes reports

Health plans and pharmacy benefit managers (PBMs) that manage drug costs speaking at this year’s Asembia Specialty Pharmacy Summit in Las Vegas say specialty drugs now account for 50% or greater of the total prescription spending they manage. In some cases, employer clients are seeing specialty costs account for 60% or even greater of their total drug spending.

“It really is frightening for our clients,” Lucille Accetta, senior vice president of pharmacy benefit management and specialty product development at CVS Health told hundreds of attendees at the Asembia event, which runs through Thursday and drew more than 5,000 people from the healthcare industry. “We have to be the best purchaser for our clients.” * * *

To reign in the costs of prescription drugs while maintaining access to life-saving treatments, health plans and pharmacies say they are more closely monitoring patients as soon as they are on the drug, said Rina Shah, group vice president of pharmacy operations and services at Walgreens.

The Forbes article adds

Abarca Health [is] an independent PBM that manages more than $5 billion in drug costs annually for more than four million Americans has executives at this week’s Asembia meeting talking up its efforts to better manage specialty pharmacy costs.

The company’s Assura solution launched earlier this year “guarantees the net cost of drugs, including specialty medications, by offering an annual fixed per script cost for a health plan’s entire population,” Abarca said in announcing the new pricing solution earlier this year. The guarantee, Abarca CEO Jason Borschow says, is adjusted each year based on drug benefit coverage changes.

From the healthcare business front

Healthcare Dive informs us

Even as COVID-19’s benefit waned, new plan members across multiple product lines helped drive CVS to $2.3 billion in profit in the first quarter, slightly higher than the $2.2 billion brought in at the same time last year.

In results published Wednesday, the company beat Wall Street expectations on earnings and revenue, with a topline of $76.8 billion, up 11% year over year.

Fierce Healthcare explains how CVS has shifted from a retail to a digital marketing focus.

The Wall Street Journal reports

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RN

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax. * * *

Moderna is the latest drugmaker to show surging sales due to demand for Covid-19 vaccines and treatments, following recent reports fromEli Lilly & Co., Merck & Co. and Pfizer Inc.

From the health risks front, MedPage Today explains that

Seven risk factors, some modifiable and some not, accounted for the vast majority of risk for first-time acute myocardial infarction (MI) in young adults, according to a case-control study.

The seven factors — diabetes, depression, hypertension, smoking, family history of premature MI, low household income, and hypercholesterolemia — were responsible for 83.9% of the total acute MI risk in young women and 85.1% of the risk in young men, reported Harlan Krumholz, MD, SM, of Yale New Haven Hospital in New Haven, Connecticut, and colleagues.

The UPI reports

Older adults who obtain a flu shot are less likely to suffer a heart attack or stroke and are at lower risk for death from heart-related health events in the year after getting vaccinated, an analysis published Friday found.

Just under 4% of older adults vaccinated against the seasonal virus experienced a “cardiovascular event” within the next year compared to just over 5% of those who did not receive the shot, data published Friday by JAMA Network Open showed.

From the meetings department,

  • HHS provides a readout of a high-level meeting among Labor Department, health insurance and business executives “to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic, as the nation observes Mental Health Awareness Month.”
  • The National Committee for Quality Assurance reviews the presentations at last week’s Quality Talks conference.

From the federal employee benefits front, FedWeek discusses OPM’s planned improvement to processing retirement applications as unveiled in the Fiscal Year 2023 budget document. Processing federal retirement benefits will be a heavy lift for OPM until Congress simplifies the pension calculation.