Midweek Update

Employee Wellness Programs

Midweek Update

David Ermer–COVID-19, COVID-19 vaccine, Employee Wellness Programs, Rx coverage, U.S. Healthcare, Uncategorized–

From the Omicron and siblings front —

The Centers for Disease Control’s Advisory Committee on Immunization Practice meets Thursday to vote on recommending the Moderna Covid vaccine for younger folks aged 6 through 17. This drug would be an alternative Pfizer’s Covid vaccine for that age group. Assuming the ACIP votes in favor of the Moderna vaccine, then CDC Director must approve their recommendation for the health plan coverage with no cost-sharing mandate to kick in.

Medical Economics informs us

Electronic messages and postcards with primary care physicians’ (PCP) names got Black and Latino patients in the door for their COVID-19 vaccines.

Although the effects were “relatively modest,” if applied on a larger scale, an additional 238,000 Black and Latino older adults may have been vaccinated across the United States, according to a new study.

Kaiser Permanente Northern California’s Division of Research examined the effectiveness of standard and culturally tailored electronic messages and mailings from patients’ own PCPs encouraging COVID-19 vaccines from March 29 to May 20, 2021. The results were published in an original investigation, “Effect of Electronic and Mail Outreach from Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial,” in the journal JAMA Network Open.

The study involved 8,287 patients aged 65 years and older, around the California Central Valley, Fresno, South Sacramento and San Jose, divided into three groups.

This study again illustrates the value of health plans teaming with primary care providers.

From the nicotine front, the Wall Street Journal devined from the federal government’s Spring 2022 regulatory agenda, posted Tuesday, that

The Biden administration is moving forward on a plan to mandate the elimination of nearly all nicotine in cigarettes, a policy that would upend the $95 billion U.S. cigarette industry and, health officials say, prompt millions of people to quit smoking.

The plan, unveiled Tuesday as part of the administration’s agenda of regulatory actions, likely wouldn’t take effect for several years. The Food and Drug Administration plans to publish a proposed rule in May 2023, though the agency cautioned that date could change. Then the agency would invite public comments before publishing a final rule. Tobacco companies could then sue, which could further delay the policy’s implementation.

Also the Journal reports

The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.

The FDA could announce its decision as early as this week, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.

Uncertainty has clouded Juul since it landed in the FDA’s sights four years ago, when its fruity flavors and hip marketing were blamed for fueling a surge of underage vaping. The company since then has been trying to regain the trust of regulators and the public. It limited its marketing and in 2019 stopped selling sweet and fruity flavors.

The company’s legal actions likely are in development now.

From the Rx coverage front —

Fierce Healthcare calls to our attention expert opinions rendered on better controlling prescription drug costs at an AHIP conference. The experts agreed that all of the stakeholders need to be at the negotiating table.

Scott Gottlieb, M.D., former Food and Drug Administration commissioner, on a panel at AHIP’s 2022 conference * * * said the challenge for regulators looking to address drug prices is the fact that a one-size-fits-all solution will not work in this market. He said instead that policymakers should consider pharmaceuticals in three buckets: drugs that are in an active market with significant rebate activity; drugs that currently monopolize the market but will lose that monopoly in the near future; and drugs that are likely to monopolize a market in the long term.

“I think we need to think about the market as those three segments and think about different policy solutions for each of them,” [and attention should be focused on the third category] Gottlieb said.

The FEHBlog agrees with the experts about the importance of engaging all of the stakeholders. There are no bad guys here at least in the FEHBlog’s view.

From the preventive services front, Medscape reports

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the United States Preventive Services Task Force (USPSTF) concludes.

However, there are two vitamins — vitamin E and beta-carotene — that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos, it notes.

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer.

The statement is published in the June 21 issue of JAMA, along with an evidence report, editorial, and patient page.

Medscape adds that this USPSTF decision aligns with a 2014 recommendation on the same topic.

From the lab test coverage front, Fierce Healthcare reports

Optum is launching a new health plan solution that aims to reduce unnecessary testing and ensure that patients are receiving the screenings that are best for them.

The laboratory benefit management tool will assist insurers in aligning lab tests with clinical guidance and will automate large parts of lab benefit administration, Optum said in an announcement provided first to Fierce Healthcare.

The company estimates that insurers could save between $12 to $36 per member per year, or about $3 billion.

Tests that lack clinical indications can lead to unneeded sample collection form patients as well as a higher risk of false positive results, which can compound unnecessary healthcare costs. There is a dearth of industry standards and efficacy data around lab tests, making it common for results to be misinterpreted or tests to be misused.

Fierce Healthcare adds that Optum is selling this tool to all health plans.

From the U.S. healthcare front, U.S. News and World Report offers 2022 rankings on the healthiest counties in the U.S. The FEHBlog recently moved from Montgomery County Maryland to Hays County Texas. Both counties score about 55 out of 100 in the rankings.

Weekend Update / Monday Roundup

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Mental health care, Telehealth, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

The Senate will and the House of Representatives will be engaged only in Committee business this coming week.

From the Omnicron and siblings front —

  • Fortune reports “The U.S. is experiencing a sixth wave of COVID, with over 90,000 confirmed new cases a day and a 20% increase in hospitalizations over the past two weeks. The actual number of new cases per day likely sits at a half-million or more, “far greater than any of the U.S. prior waves, except Omicron,” writes Dr. Eric Topol, the executive vice president of Scripps Research and a professor of molecular medicine, in a recent blog post on the maps.” It’s hard to argue against this point.
  • Bloomberg Prognosis offers a useful Q&A on when you can back to life after a case of Omicron. Here is a link to the CDC’s guidelines on isolation and quarantine due to Omicron.
  • The FEHBlog noticed that 75% of the American population age 12 and older is fully vaccinated against Covid.
  • The American Medical Association discusses how Covid telemonitoring sets the model for other acute conditions.

From the Aduhelm front, the Wall Street Journal reports

The commercial failure of Biogen Inc.’s drug Aduhelm is putting new focus on the state of research into the causes of Alzheimer’s disease.

More than six million people in the U.S. are living with the progressive type of dementia, according to the Alzheimer’s Association, an advocacy group. 

Aduhelm was hailed as a potential blockbuster that targeted a root cause of the disease by clearing a sticky protein known as amyloid from the brain. Abnormal accumulations of amyloid called plaque and tangles of another protein known as tau are characteristic features of the brains of people with Alzheimer’s.

“If you cut the brain open and amyloid plaque is absent, Alzheimer’s was not the cause of disease,” said Jeffrey Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas.

But research into the benefits of targeting amyloid in Alzheimer’s patients has been mixed. There are more questions than answers about the role amyloid plays in the development of the disease, neurologists say. 

“Alzheimer’s is a complex disease. It’s unlikely that a single mechanism is contributing to it,” said Maria Carillo, the Alzheimer’s Association’s chief science officer. * * *

More than 140 drugs are in the pipeline as potential Alzheimer’s treatments, including drugs that target tau and microglia function, according to a survey of registered clinical trials in the U.S. Three other amyloid-targeting monoclonal antibodies, which are in the same class as Aduhelm, are in development. One, called lecanemab, was submitted this month by co-developers Biogen and Japan-based Eisai Co. to the Food and Drug Administration for potential approval.

Time will tell.

From the preventive care wellness front —

  • Medscape reports an “alarming increase in esophageal cancers in middle-aged adults. The study’s author,  Bashar Qumseya, MD, MPH, recommends that people with multiple risk factors for these cancers, i.e., obesity, diet, and gastroesophageal reflux disease, should undergo an endoscopy at the time of their first colonoscopy at age 45.
  • The American Medical Association identifies steps that patients can follow to reverse pre-diabetes.

The FEHBlog just discovered that the Weekend Update did not go out on Monday morning. So here are Monday’s items that normally would have been posted in the Monday Roundup —

More from the Omicron and siblings front —

BioPharma Dive reports

Three doses of Pfizer and BioNTech’s COVID-19 vaccine met the Food and Drug Administration’s bar for success in a trial studying the shot in children younger than 5 years old, the companies said Monday. The FDA has tentatively scheduled a meeting of outside advisers to review the data in three weeks.

The agency delayed review of the vaccine in the youngest children earlier this year after a December review of data indicated a two-shot series didn’t spur an immune response that was likely to protect against disease. When Pfizer and BioNTech disclosed that data, they announced plans to test immune response and efficacy after three shots.

The announcement comes days after U.S. officials warned of a new surge of COVID-19 cases as mask mandates have been lifted and while immunity from vaccination and previous infections wanes. The FDA has granted emergency use authorization for as many as four shots of Pfizer and BioNTech’s vaccine — an initial two-dose series followed by two periodic boosters — for adults at least 50 years old.

Reuters adds U.S. “Health officials are considering extending the eligibility for a second COVID-19 vaccine booster dose to people under 50 amid a steady rise in cases, with the United States seeing a threefold increase over the past month.”

Bloomberg Prognosis recommends carrying around a portable carbon dioxide monitor to help prevent Covid or at least remind you to mask up and / or move along:

Carbon-dioxide monitors can assess how Covid-risky a space is because they help tell you whether you’re breathing in clean air. They measure the concentration of carbon dioxide, which people exhale when they breathe, along with other things like, potentially, virus particles. The more well-ventilated a space, the lower the reading on my monitor’s screen — meaning not only less carbon dioxide but also less of the stuff like Covid that might make people sick. 

One place I didn’t expect this to be an issue was airplanes, because you hear so much about their top-of-the-line air quality systems. But in fact, some of the highest carbon dioxide readings on my travels were taken on flights, specifically during the boarding process.

It turns out that during boarding and deplaning, air systems aren’t typically running. Those periods are risky because people are mingling more than they do during a flight, says Joe Allen, an associate professor at the Harvard T.H. Chan School of Public Health who carries around his own CO2 monitor.

“We’ve been warning about this,” Allen says. 

Fresh air is important for our health in ways that go well beyond Covid, but it’s also largely invisible. Carbon-dioxide monitors can change that. 

What will they think of next?

The FEHBlog confesses that he took his eye off the flu virus this year. Beckers Hospital Review informs us “The CDC estimates there have been at least 6.7 million flu illnesses, 69,000 hospitalizations and 4,200 flu-related deaths so far this season.”

In other virus news, Reuters reports “Infection with adenovirus, a common childhood virus, is the leading hypothesis for recent cases of severe hepatitis of unknown origin in children that have led to at least six deaths, U.S. health officials said on Friday [May 20]. Furthermore,

The Centers for Disease Control and Prevention (CDC) said it is continuing to investigate whether 180 cases identified in 36 states and territories since last October represent an increase in the rate of pediatric hepatitis or whether an existing pattern has been revealed though improved detection.

From the mental healthcare front, Fierce Healthcare tells us

Mental health concerns are on the rise among teens, and the impact on parents and families is an unmet need employers could address, new data from Cigna’s Evernorth show.

The pandemic has significantly worsened mental health among teens and young adults, with 25% experiencing depressive symptoms and 20% experiencing anxiety symptoms, a JAMA study shows. About 80% of the 1,000 parents included in Cigna’s survey said their children are struggling with their mental health.

Nearly one-fifth (18%) of parents say their child’s needs are negatively impacting their job performance and productivity, according to the survey. In addition, 55% said they do not have enough support from their employer, and 1 in 7 said they were forced to leave or stay out of the workforce to manage their teenager’s needs.

“I think there’s going to be a long tail for these kids and also their family members,” Stuart Lustig, M.D., national medical executive for behavioral health at Evernorth, told Fierce Healthcare. “I think we’re in this for the long haul.”

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.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill

Roll Call tells us

Senators negotiating a COVID-19 supplemental funding package have an “agreement in principle” to provide roughly $10 billion for the Department of Health and Human Services to stock up on waning domestic supplies for combating the virus, according to Sen. Roy Blunt, R-Mo.

Blunt, the top Republican on the Senate Labor-HHS-Education Appropriations Subcommittee, said both parties have tentatively agreed to offsets for the $10 billion that would repurpose unspent funds from prior pandemic relief laws.

The offsets negotiators agreed to include $2.2 billion from unused grant funds for venues like zoos and theaters and $2 billion in untapped assistance to the aviation and manufacturing industry, Blunt said. His comments to reporters came after a Republican Conference lunch in which lead GOP negotiator Sen. Mitt Romney of Utah briefed his colleagues on the agreement in principle. 

Fierce Healthcare informs us

The House [of Representatives] passed a bill on Thursday that caps the out-of-pocket cost of insulin at $35 a month for beneficiaries in Medicare Part D and for certain group and individual plans.

The Affordable Insulin Now Act, which passed the House via a 232 to 193 vote, comes as work in the Senate continues on a bipartisan alternative that could bring additional changes. * * *

Private plans would also be required to offer first-dollar coverage of insulin without any deductible, according to an analysis from the Congressional Budget Office. 

The cap on cost-sharing for private insurance plans would implement in 2023.

The Hill offers a related article explaining why insulin prices are so “troubling” high.

HR Dive reports

Among the provisions of this month’s $1.5 trillion omnibus spending bill, Congress included a revival of an exemption that allowed high-deductible health plans to cover telehealth before individuals meet their deductible.

The provision was originally created by the Coronavirus Aid, Relief, and Economic Security Act, which sunset at the end of 2021. The provision will resume April 1 but will again sunset at the end of this year.

From the Omicron and siblings front, the Wall Street Journal discusses the state of Covid treatments and offers its advice on who should seek out a second Covid booster besides the immunocompromised.

From the OPM front, Govexec projects OPM’s actions over the next 18 months based on the FY 2022 to FY 2026 strategic plan released last Monday. In short, “Hire, Hire, Hire.”

Govexec also discusses efforts underway by OPM, the Social Security Administration and the Thrift Savings Plan to improve the customer service experience of federal employees and retirees. Good luck with that.

From the research front the National Institutes of Health announced

Scientists have published the first complete, gapless sequence of a human genome, two decades after the Human Genome Project produced the first draft human genome sequence. According to researchers, having a complete, gap-free sequence of the roughly 3 billion bases (or “letters”) in our DNA is critical for understanding the full spectrum of human genomic variation and for understanding the genetic contributions to certain diseases. The work was done by the Telomere to Telomere (T2T) consortium, which included leadership from researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health; University of California, Santa Cruz; and University of Washington, Seattle. NHGRI was the primary funder of the study.

Analyses of the complete genome sequence will significantly add to our knowledge of chromosomes, including more accurate maps for five chromosome arms, which opens new lines of research. This helps answer basic biology questions about how chromosomes properly segregate and divide. The T2T consortium used the now-complete genome sequence as a reference to discover more than 2 million additional variants in the human genome. These studies provide more accurate information about the genomic variants within 622 medically relevant genes. * * *

The now-complete human genome sequence will be particularly valuable for studies that aim to establish comprehensive views of human genomic variation, or how people’s DNA differs. Such insights are vital for understanding the genetic contributions to certain diseases and for using genome sequence as a routine part of clinical care in the future. Many research groups have already started using a pre-release version of the complete human genome sequence for their research.  

From the mental healthcare front, the American Hospital Association calls our attention to a new GAO report.

Consumers with health coverage experience challenges finding in-network mental health providers, who may not be accepting new patients or have long wait times to see them, according to a new report from the Government Accountability Office. Factors contributing to these challenges include low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks, GAO said. The report also looks at ongoing and planned federal efforts to address these challenges, for example by increasing the mental health workforce, mental health system capacity and oversight of health plan compliance with mental health parity laws.

This squib caused the FEHBlog to recall a comment that he heard at a conference — Four out of five doctors are in-network but only one out of five mental health providers are in-network with the notable exception of hub and spoke telemental services.

Yesterday the FEHBlog suggested that in return for three free primary care visits and three behavioral health visits, plan members should name and use their in-network primary care provider and primary mental health provider. The FEHBlog is sticking with this idea for the in-network primary care provider but he recognizes the idea may be premature for the in-network primary mental health provider. Of course, creating a looser standard for free mental health care compared to primary care is compliant with the federal health parity rule. The reverse would violate the often fuzzy non-quantitative treatment limitations created by the law.

From the miscellany department —

  • STAT News tells us “With Medicare expected to cover a projected 80 million people by 2030,He entrepreneurs and investors are cashing in on what analysts see as an inevitable shift in health care away from the hospital and into the homes of aging patients.” The publication identifies five related technology trends.
  • Fierce Healthcare reports “Virtual care startup Hims & Hers is teaming up with Carbon Health to offer patients in California with direct access to providers for in-person medical appointments at clinics. The collaboration will provide easy and comprehensive access to a broader range of care options through the Hims & Hers platform, company executives said.”
  • Health Payer Intelligence informs us “Large employers are investing more in their wellness program design in 2022 and their programs revolve around hybrid work environments, job satisfaction, and equity, the Business Group on Health found in a survey.”

Midweek update

David Ermer–CDC, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Piron Guillaume on Unsplash

In addition to being Wednesday, today is September 1 which marks the beginning of at least three healthcare related observances”

  • Each September, the American Medical Association’s (AMA) Women Physicians Section (WPS) honors physicians who have offered their time, wisdom and support to advance women with careers in medicine.
  • September is Sepsis Awareness Month. Here is a link to the Center for Disease Control’s Sepsis awareness page.
  • September is also National Recovery Month. The AMA identifies four ways that the Biden Administration can reduce the number of drug overdose deaths.

From the Delta variant front

The FEHBlog’s favorite newspaper columnist is David Leonhardt who writes a morning column for the New York Times. Mr. Leonhardt raises questions often on the FEHBlog’s mind after exploring the question with experts.This morning he pondered whether

the Delta-fueled Covid-19 surge in the U.S. finally peaked?

The number of new daily U.S. cases has risen less over the past week than at any point since June. * * *

Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern. * * *

In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as [University of Minnesota epidemiologist Michael] Osterholm says. Or as [Johns Hopkins epidemiologist Jennifer] Nuzzo puts it, “Our top goal has to be first shots in arms.”

Hope springs eternal.

Regading increasing the number of vaccinations, Bloomberg reports today that

Vaccine mandates are set to get more common in the workplace. 

A majority of U.S. employers — 52% — are planning or considering requirements for a Covid-19 shot by the end of the year, according to a survey released Wednesday by consultant Willis Towers Watson. That’s more than double the 21% of companies polled that currently have some form of mandate. 

The options vary, ranging from a strict order for all employees to limiting access to certain areas to inoculated workers. About 14% of respondents also said they are weighing a health-care surcharge for people who choose not to get the vaccine, while 1% are planning to impose one, according to the survey of 961 employers, conducted Aug. 18-25.

Also Fierce Biotech explores what’s next in the mRNA pipeline. Principally for the two COVID mRNA vaccine companies with large war chests

Moderna executives tout the company’s pipeline often—so we’ll be brief here. A cytomegalovirus candidate is the furthest along in the company’s prophylactic vaccine program, while other mid-stage assets include a personalized cancer vaccine and a localized regenerative therapeutic for the heart condition myocardial ischemia.

BioNTech, meanwhile, has dozens of assets in development for a host of common conditions: malaria, tuberculosis and even certain allergies. But where the German biotech is really making a mark is in oncology, where dozens of vaccines and therapeutics are in development. Just one is in phase 2: the Roche-partnered melanoma therapy BNT122. That drug is combined with Merck & Co.’s blockbuster Keytruda to treat metastatic melanoma in a study conducted with Roche’s Genentech.

The article also discusses where other large drug manufacturers stand in the developing market.

From the bankruptcy front, the Wall Street Journal reports that

OxyContin maker Purdue Pharma LP won court approval of a $4.5 billion bankruptcy settlement that shields its owners, members of the Sackler family, from lawsuits accusing them of contributing to the nation’s opioid epidemic in exchange for providing funding to combat the crisis.

Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., said Wednesday he will confirm a restructuring plan that will transform Purdue into a public benefit company and settle civil lawsuits filed by governments and opioid victims against the drugmaker and its owners. 

The ruling can be appealed by the handful of federal and state authorities that opposed Purdue’s bankruptcy-exit plan and argued at trial that the settlement structure is unconstitutional and the Sacklers aren’t contributing enough of their wealth. Purdue’s family owners collected more than $10 billion from the company between 2008 and 2017, about half of which went to taxes or was reinvested in the business.

From the miscellany front

  • Homeland Security Today informs us that “The Biden Administration, in a collaboration between the General Services Administration, the White House Office of Management and Budget, the Office of Personnel Management, the Cybersecurity and Infrastructure Security Agency, and the White House Office of Science and Technology Policy, announced the U.S. Digital Corps, a new two-year fellowship that will recruit early-career technologists to contribute to high-impact efforts across the federal government. This program will work to advance the Administration priorities of coronavirus response, economic recovery, cybersecurity, and streamlining government services.” Best of luck with this initiative.
  • The Washington Post reports that “Childhood obesity rose significantly during the pandemic,according to a new study. The greatest change was among children ages 5 to 11, who gained an average of more than five pounds, adjusted for height, according to the study published in Journal of the American Medical Association (JAMA) Network. For the average 5-year-old (about 40 pounds), that’s a 12.5 percent weight gain. For the average 11-year-old (about 82 pounds), it’s a 6 percent weight gain, according to the study. Before the pandemic, about 36 percent of 5- to 11-year-olds were considered overweight or obese, and that increased to 45.7 percent. ‘Significant weight gain occurred during the covid-19 pandemic among youths in Kaiser Permanente Southern California, especially among the youngest children,’ the study concluded. ‘These findings, if generalizable to the U.S., suggest an increase in pediatric obesity due to the pandemic.’” No bueno.
  • Employee Benefits News offers an engaging article titled “Affordable ways to help your employees tend to their mental health.

Monday Roundup

David Ermer–COVID-19, Employee Wellness Programs, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Bloomberg reports that

The Covid-19 variant that’s become the dominant strain in the U.S isn’t as deadly as earlier research indicated, although it’s confirmed to be faster-spreading than other versions, according to a study.

Among 339 patients with the coronavirus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published Monday in the Lancet Infectious Diseases journal, compared with 38% of those who had non-B.1.1.7 infections.

“We’re not saying it’s nothing, but it’s not worse in terms of outcome in our study, in our setting,” said Eleni Nastouli, a co-author of the study and an associate professor at University College London. She noted that the study differed from some earlier research, looking at patients in hospitals, rather than in the community, and making precise identifications of variants with whole-genome sequencing.

Earlier data released by a U.K. advisory group and cited by the U.S. Centers for Disease Control and Prevention indicated that B.1.1.7 might be as much as a third more deadly than other variants of the virus. 

FLASH: Bloomberg reports Tuesday morning that

U.S. health officials recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine on concerns about rare and severe blood clotting side effects. A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said Tuesday in a joint statement. As of April 12, more than 6.8 million doses of the vaccine have been administered, the agencies said.

If you had to pause one of the vaccines this would be the week to pause the Johnson & Johnson vaccine due to the manufacturing / distribution problems. Fingers crossed for a short pause.

The Department of Health and Human Services today

marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. A new data brief shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months post-partum and disruptions in Medicaid coverage often lead to periods of uninsurance, delayed care, and less preventive care. The American Rescue Plan provides an easier pathway for states to extend Medicaid postpartum coverage from 60 days to 12 months.

Secretary Becerra also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. For the first time, applicants are required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

For more information on the fourth Black Maternal Health Week, check out the Black Mamas Matter Alliance’s website.

From the prescription drug front —

  • Cigna’s Evernorth unit, which includes the Express Scripts PBM, has released its 2020 Drug Trends report. The report’s by the numbers webpage is quite illuminating.
  • STAT News informs us that

Patrizia Cavazzoni has been named the permanent leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, the agency’s acting commissioner, Janet Woodcock, announced Monday morning. The position of CDER director is one of the most influential at the sprawling agency. Cavazzoni, who is in her late 50s, was handpicked by Woodcock to join the agency in 2018 and has been leading the drug center in an acting role since last spring. Cavazzoni is known as a problem-solver who has taken on some of the FDA’s most pressing problems, former top FDA officials told STAT last year.

From the healthcare technology front —

Healthcare Dive lets us know that

Microsoft is acquiring clinical documentation and artificial intelligence company Nuance Communications for $19.7 billion, two years after first inking an R&D partnership with the speech-to-text market leader. The Redmond, Washington-based tech giant said Monday it has entered into a definitive agreement to acquire Nuance for $56 a share — a hefty price tag, representing a 23% premium on the closing price on Friday. Nuance develops conversational artificial intelligence and cloud-based ambient clinical intelligence for doctor’s offices and hospitals.

Jingle bells to Nuance Communications. Healthcare AI is obviously a big deal.

  • Becker’s Hospital Review reports that “Google is in the early stages of a new project that aims to explore and develop a new consumer-facing health records tool for Android users, according to an April 9 STAT report. * * * The project could support the development of a medical records tool similar to Apple’s Health Records app, according to the report.”

Finally here’s an interesting smoking cessation twist from Healio:

A parental smoking intervention was effective and “inexpensive” to implement in pediatric primary care practices, with costs per quit that were comparable to other interventions, according to researchers. * * * “The impetus for screening parents for tobacco use in the pediatric setting is to protect children from exposure to secondhand smoke,” Douglas E. Levy, PhD, MPH, associate professor of medicine at Harvard Medical School and associate investigator at the Mongan Institute Health Policy Center at Massachusetts General Hospital, told Healio Primary Care. “Parents may be more receptive to smoking cessation messages when the recommendation comes from pediatric health care providers because the benefits are framed in terms of protecting their child’s health.”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Bloomberg reports that “President Joe Biden said [today] he wants all American adults eligible for a coronavirus vaccine by April 19, two weeks earlier than his previous goal. All but two states are already set to meet that goal, with Oregon and Hawaii having planned to open up vaccines to all non-minors on May 1.”

Yesterday, the Centers for Disease Control (“CDC”) released a report finding that “The principal mode by which people are infected with SARS-CoV-2 (the virus that causes COVID-19) is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low.” As this BBC News article illustrates, last Spring we were quite worried about contracting COVID-19 from contaminated surfaces. In any event, thank heavens that we have the vaccines.

Federal News Network reports that front line federal employee access to the COVID-19 vaccine depends upon their employing agency.

If you are a federal employee working in the field, like Food and Drug Administration inspectors, Forest Service rangers or Custom and Border Protection officers, getting a COVID-19 vaccine from your agency isn’t a sure thing.

The Department of Homeland Security is making an all-out effort to vaccinate all 300,000 employees.

Other agencies like the Agriculture Department or the IRS are asking employees to take a path through their state and local governments.

This inconsistent application of agency support for “frontline” workers to receive one of the three inoculations has the potential to create a have and have nots among agencies.

Hopefully as the COVID-19 vaccine supply continues to expand and access restrictions are removed, these unfortunate quirks in the process will be ironed out quickly.

In other healthcare related tidbits

  • On April 12, the CDC will be sponsoring its decennial meeting on healthcare associated infections.
  • The Food and Drug Administration released a COVID-19 update today. The FEHBlog wonders when the FDA will take up granting full marketing approval for the Pfizer and Moderna vaccines and when AstraZeneca will file an emergency use authorization with the FDA for its COVID-19 vaccine. Those steps take us closer to ironing out the process quirks.
  • MedPage Today reports that

A personalized, hands-on care strategy for patients struggling with addiction was effective at reducing hospital readmission, a randomized trial found. In a comparison of hospitalized adults with substance use disorder involving opioids, cocaine, or alcohol, those who received Navigation Services to Avoid Rehospitalization (NavSTAR) care saw far better outcomes than those who simply received treatment as usual, according to Jan Gryczynski, PhD, of the Friends Research Institute in Baltimore, and colleagues.

  • Health Payer Intelligence informs us that

A digital therapeutic weight loss program led to major medical cost savings, according to a Rally Health Inc. study that points to wellness programs as cost-effective strategies to tackle the obesity epidemic. The study published in Obesity examined program data over a three-year period to analyze medical cost trends for those participating in Rally Health’s Real Appeal weight loss intervention program.

Researchers compared medical costs for a group of participants in the digital therapeutic wellness program with costs for a control group of non-participants. The control group was selected to match the intervention group in terms of health risk, baseline medical costs, age, gender, geographic region, and chronic conditions.

The study found that the wellness programming resulted in significant weight loss. There was an average weight loss of 3 percent for 4,790 program participants who attended at least one session over a 52-week period. In addition to providing positive member outcomes, the wellness program lowered medical expenditures significantly. Costs for the intervention cohort were 12 percent less than costs for the control group. What’s more, the savings of the wellness program cohort were 2.3 times more than program costs, marking significant return on investment.

  • Adam Fein reports in his Drug Channels blog that

The drug channel is consolidating, both vertically and horizontally. For evidence, look no further than Drug Channels Institute’s estimates of pharmacy benefit manager (PBM) market share, which are shown in the chart below. For 2020, DCI estimates that the three biggest PBMs [CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group] accounted for more than three-quarters of total equivalent prescription claims. * * * This concentration helps plan sponsors and payers, which can maximize their negotiating leverage by combining their prescription volumes within a small number of PBMs. 

Thursday Miscellany

David Ermer–CDC, COVID-19, Employee Wellness Programs, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

In a welcome spurt of cautious optimism, Bloomberg reports this evening

The U.S. vaccine supply is poised to double in the coming weeks and months, according to an analysis by Bloomberg, allowing a broad expansion of doses administered across the country. * * * A review of drugmakers’ public statements and their supply deals suggests that the number of vaccines delivered should rise to almost 20 million a week in March, more than 25 million a week in April and May, and over 30 million a week June. By summer, it would be enough to give 4.5 million shots a day.  * * * The analysis assumes drugmakers will meet their new delivery targets — not a guarantee in a year-old pandemic where much has gone wrong.

The FEHBlog’s bet, for what it’s worth, is that Bloomberg’s analysis proves correct.

The urgency of rapid COVID-19 vaccine distribution is reinforced by the Centers for Disease Control’s report today that U.S. life expectancy dropped by one year during the first six months of last year.

For perspective, take a look at the American Medical Association’s interview of John Barry, the author of the Great Influenza. To wit –

In 1918, people didn’t buy the government’s take on the pandemic. They saw what was happening. The disease was much more virulent, killing between 50 million and 100 million people. That would be between 225–450 million people today after adjusting for population. In Philadelphia, Barry said, priests would drive horse-drawn carts down the street calling for people to bring out their dead.

Mr. Barry urges truth telling by all parties holding public trust. By the way, the Great Influenza is fascinating reading.

In regulatory news —

  • Fierce Healthcare informs us that “President Joe Biden has chosen Chiquita Brooks-LaSure to lead the Centers for Medicare & Medicaid Services (CMS), according to a report in The Washington Post.” This post requires Senate confirmation.
  • The National Law Journal reports that “The U.S. Equal Employment Opportunity Commission (EEOC) announced last Friday that it was withdrawing two proposed rules regarding the incentives employers can provide their employees as part of a wellness program without violating the Americans with Disabilities Act (ADA) or Genetic Information Nondiscrimination Act (GINA). Originally, the proposed rules had stated that, for the most part, employers could offer only “de minimis” incentives for employees participating in a wellness program—incentives that potentially could apply to employees receiving a coronavirus (COVID-19) vaccine. With the withdrawal of those rules, employers have little guidance in terms of what incentives, if any, they may offer employees”
  • The Health and Human Services Inspector General announced a court ordered delay in effective date of the Trump Administrations’ rule banning prescription drug rebates in Medicare Part D (but not the FEHBP) to January 1, 2023.
  • The Internal Revenue Service issued guidance implementing the following cafeteria plan changes created by the Consolidated Appropriations Act, 2021. The new law

Provides flexibility with respect to carryovers of unused amounts from the 2020 and 2021 plan years;

Extends the permissible period for incurring claims for plan years ending in 2020 and 2021;

Provides a special rule regarding post-termination reimbursements from health FSAs during plan years 2020 and 2021;

Provides a special claims period and carryover rule for dependent care assistance programs when a dependent “ages out” during the COVID-19 public health emergency; and

Allows certain mid-year election changes for health FSAs and dependent care assistance programs for plan years ending in 2021.

This notice also provides additional relief with respect to mid-year elections for plan years ending in 2021. 

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Employee Wellness Programs–
Photo by Sven Read on Unsplash

The Centers for Medicare and Medicaid Services has released a COVID-19 Vaccine Toolkit for health insurance issuers and Medicare Advantage plans. The toolkit’s purpose is as follows:

CMS is committed to ensuring that the private health insurance industry has the necessary tools to respond to the COVID-19 public health emergency (PHE). As safe and effective COVID- 19 vaccines become available, CMS issued this toolkit to help health insurance issuers and Medicare Advantage plans identify the issues that need to be considered and addressed in order to provide coverage and reimbursement for vaccine administration. Because COVID-19 vaccines will be federally purchased, this toolkit primarily focuses on vaccine administration. CMS remains available to provide technical assistance to issuers, Medicare Advantage plans, and other stakeholders. This toolkit:
• Provides a list of operational considerations for issuers and Medicare Advantage plans as they design their approach to promoting COVID-19 vaccinations and information on how issuers and Medicare Advantage plans can communicate with providers and enrollees on vaccinations and coverage;
• Outlines legislative and regulatory provisions applicable to issuers that ensure that enrollees can receive a COVID-19 vaccine in a convenient setting, with no out-of-pocket costs;
• Encourages issuers and Medicare Advantage plans to implement streamlined processes to quickly administer COVID-19 vaccine coverage; and • Describes how issuers and Medicare Advantage plans can maximize the number of their enrollees who get vaccinated once a COVID-19 vaccine becomes available

Meanwhile the Centers for Disease Control have released facts sheets on what to expect after you receive your first dose of COVID-19 vaccine and how to improve ventilation in your house during the great hunkering down.

Benefits Pro reports that the Equal Employment Opportunity Commission is poised to release proposed rules addressing the level of incentives employers may lawfully offer to encourage employee participation in wellness programs that require disclosure of medical information. “

Because the {Americans with Disabilities Act] ADA and [Genetic Information Non-Discrimination Act] GINA do not define “voluntary,” the NPRM proposes that in order to comply with the acts, employers may offer no more than a “de minimis” incentive to encourage participation in wellness programs. The exception would be for “wellness programs that are part of, or qualify as, group health plans and that require employees to satisfy a standard related to a health factor to receive a reward or avoid a penalty,” according to the proposed rule under the ADA.

Under the GINA regulation, the proposed rule makes an exception that would allow incentives for genetic information “when a wellness program offers an employee an incentive in return for his or her family member providing information about the family member’s manifestation of disease or disorder.”

Midweek update

David Ermer–COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Uncategorized–
Photo by Manasvita S on Unsplash

More good COVID-19 vaccine news today. The Wall Street Journal reports that following up on Monday’s favorable initial report on the phase three study of their COVID-19 vaccine, Pfizer and BioNTech announced the final report on that study.

Pfizer Inc. said it will ask health regulators to authorize its experimental Covid-19 vaccine within days, after reporting the shot was 95% effective in its pivotal study and showed signs of being safe. The company’s plans, announced Wednesday, mean the shot is on track to go into distribution by the end of the year, if the regulators permit.

Pfizer and BioNTech said that of the nearly 44,000 adults in the U.S. and in other countries who took part in the study, 170 developed Covid-19 with at least one symptom. Out of those, just eight had taken the vaccine, while 162 had received a placebo. The resulting 95% effectiveness rate puts the shot’s performance on par with shingles and measles vaccines. It is also consistent with last week’s peek at how it did in an analysis of the first 94 subjects to fall sick.

The infected subjects included 10 severe cases of Covid-19, with nine in the placebo group and one in the vaccine group. The vaccine was effective across different ages, races and ethnic groups, and it was more than 94% effective in adults over 65 years old, the companies said. About 42% of the trial participants are from racial or ethnic minority groups, while 41% are ages 56 to 85, the companies said.

Moreover, medical device manufacturer Lucira Health announced today that

Late yesterday the U.S. Food and Drug Administration (FDA) authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. The FDA issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results. The Lucira™ COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers.

Healthcare Dive indicates that the initial price for the test will be about $50.

Benefits Pro points us to a CIGNA report titled “Health and Wellness in Workplaces: What Works? ROI Analysis of Health and Wellness Interventions” which “is the largest global review of the impact of workplace wellness interventions, according to researchers.” Top line findings are that focused wellness programs deliver the greatest impact for employers and that mental health interventions yield the most significant return on the employer’s investment.

Fierce Healthcare reports that the American Medical Association’s House of Delegates is on the warpath against employer sponsored high deductible plans. “In 2010, about 25.3% of people were enrolled in a high-deductible plan, with that number rising to 40% in 2016.” The article overlooks the important fact that participating in such a plan is the key to opening a triple tax free health savings account.