Tuesday’s Tidbits

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare reports

New bipartisan legislation introduced in the Senate aims to empower the Federal Trade Commission (FTC) to crack down on pharmacy benefit manager practices such as spread pricing.

The legislation, introduced Tuesday, comes as the PBM industry faces other areas of reform, including a proposed rule to get rid of clawback fees PBMs can charge pharmacies after the drug is dispensed.

Lawmakers said federal agencies need more power, though, to rein in PBM practices. 

From the No Surprises Act (“NSA”) front, AHIP and the Blue Cross Association inform us

A recent survey and analysis conducted by AHIP and the Blue Cross Blue Shield Association (BCBSA) found that in the first two months of 2022, the NSA prevented more than 2,000,000 potential surprise medical bills across all commercially insured patients. If only a fraction of these claims are ultimately disputed through IDR, it would still far exceed the government’s estimate. Should the trend hold, more than 12,000,000 surprise bills will be avoided in 2022 due to the NSA.

The law is working to protect millions of consumers from costly surprise bills and yet several hospital and provider organizations have filed lawsuits challenging the NSA regulations and legislation in order to increase their own profits at patients’ expense. Recent polling conducted by Morning Consult on behalf of the Coalition Against Surprise Medical Billing found that 8 in 10 voters, after learning about the NSA, are concerned that lawsuits from physician and hospital organizations could delay or overturn the patient protections in the Act.

The findings of the AHIP-BCBSA survey are important to demonstrate how many consumers have already benefitted from the NSA and to underscore the extent of total claims that could be impacted if the IDR process is not a predictable process with payment amounts that trend towards market rates.

That’s great news.

In public health news, the American Hospital Association tells us ‘

U.S. births rose 1% in 2021 to about 3.7 million, the first increase since 2014, according to preliminary data released today by the Centers for Disease Control and Prevention. Birth rates declined for women aged 15-24 and rose for women aged 25-49. The cesarean delivery rate rose 0.3 percentage point to 32.1%, while the preterm birth rate rose 4% to 10.48%, the highest rate since 2007, CDC said.

From the Omicron and siblings front

  • Reuters reports “The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc’s emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc’s vaccine for those aged 6 months through 4 years.”
  • Precision Vaccines tells us “The U.S. Centers for Disease Control and Prevention (CDC) issued today Health Alert Network Health Advisory CDCHAN-00467 to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 Rebound.”  COVID-19 Rebound cases have been reported to occur between two and 8 days after initial recovery. They are characterized by a recurrence of COVID-19 symptoms or a new positive viral test after testing negative.  A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the beta coronavirus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.” STAT News offers a more detailed article on this topic for those interested.

In other virus news, the Hill informs us

Officials for the Centers for Disease Control and Prevention (CDC) on Monday said the agency is releasing doses of a smallpox vaccine in response to the few recent cases of monkeypox that have been detected in the U.S. Jennifer McQuiston, the deputy director for the CDC’s Division of High Consequence Pathogens and Pathology, said during a press briefing that more than a thousand doses of the Jynneos smallpox vaccine are currently available in the U.S., with more doses expected to become available as production ramps up. * * * The vaccines will be designated for people who are most likely to benefit from them, McQuiston said, including those who are known to have had close contact with monkeypox patients, health care workers and people who would be at high risk of developing a severe case of the disease.

From the healthcare business front, Beckers Hospital News identifies Walmart’s 18 Centers of Excellence in the U.S.

In National Institutes of Health news, NIH Reseach Matters discusses antioxidant effects on dementia risk and how the health benefits of dietary fibers depend on the fiber type, the amount, and the individual.”

Weekend Update / Monday Roundup

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

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 recommendsimproving 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.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The Secretary of Health and Human Services has extended the Covid public health emergency for another 90 days. Bloomberg explains, “The declaration allows the US to grant emergency authorizations of drugs, vaccines and other medical countermeasures, as well as administer those products to millions of people at no out-of-pocket cost. It’s also enabled millions of Americans to get health coverage through Medicaid, among other benefits.” Bloomberg’s sources expect the declaration to be renewed again in July 2022.

The American Hospital Association informs us

The Food and Drug Administration today authorized a single Pfizer COVID-19 booster dose for children aged 5-11 who completed the Pfizer vaccine primary series at least five months before. FDA authorized the vaccine for this age group last October.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research.

In public health news —

  • The federal government’s Million Hearts campaign has launched a website discussing hypertensive disorders of pregnancy. The site explains “Hypertensive disorders of pregnancy are a leading cause of maternal mortality and can put both mother and baby at risk for problems during pregnancy.1 High blood pressure can also cause problems during and after delivery. Importantly, hypertensive disorders of pregnancy are often preventable and treatable.”
  • The Centers for Disease Control has updated its website discussing diabetes and heart disease. The FEHBlog knows from his PCP about the dangerous relationship between those two diseases.

In survey news —

  • Beckers Hospital Review relates that “The Lown Institute, a nonpartisan healthcare think tank, released its ranking May 17 of the best hospitals in the U.S. for avoiding overuse of low-value tests and procedures.”
  • Fierce Healthcare tells us, “Utah is the healthiest state for seniors this year, earning high marks for low prevalence of smoking and excessive drinking, according to a new report from the United Health Foundation. The philanthropic arm of UnitedHealth Group issued its annual America’s Health Rankings senior report Tuesday morning, which highlights state-specific performance across a slew of measures as well as progress, or lack thereof, on several key health issues facing seniors.”

From the healthcare business front

Fierce Healthcare reports

Private insurance plans paid hospitals on average 224% more compared with Medicare rates for both inpatient and outpatient services in 2020, a new study found. 

Researchers at RAND Corporation looked at data from 4,000 hospitals in 49 states from 2018 to 2020. While the 224% increase in rates is high, it is a slight reduction from the 247% reported in 2018 in the last study RAND performed. 

“This reduction is a result of a substantial increase in the volume of claims in the analysis from states with prices below the previous average price,” the study said. 

The report showed that plans in certain states wound up paying hospitals more than others. It found that Florida, West Virginia and South Carolina had prices that were at or even higher than 310% of Medicare. 

But other states like Hawaii, Arkansas and Washington paid less than 175% of Medicare rates. 

The American Hospital Association replies

The RAND Corporation’s latest hospital pricing report again “overreaches and jumps to unfounded conclusions based on incomplete data,” AHA President and CEO Rick Pollacksaid today. “The report looks at claims for just 2.2% of overall hospital spending, which, no matter how you slice it, represents a small share of what actually happens in hospitals and health systems in the real world. RAND also continues to ignore that hospitals are not all the same. Researchers should expect variation in the cost of delivering services across the wide range of U.S. hospitals — from rural critical access hospitals to large academic medical centers. Tellingly, when RAND added more claims as compared to previous versions of this report, the average price for hospital services declined. This suggests what we have long suspected: you simply cannot draw credible conclusions from such a limited and biased set of claims. 

“Further, the results highlight what even the Medicare Payment Advisory Commission (MedPAC) acknowledges: Medicare does not fully cover the cost of providing care to Medicare beneficiaries. Pinning commercial prices to inadequate Medicare rates would cause even more financial strain to hospitals already facing tremendous challenges as a result of the ongoing COVID-19 pandemic and rising inflation. The result could be reduced patient access to care.” 

I agree with the American Hospital Association that the problem is Medicare. Why Sen. Sanders continues to push Medicare for All is a mystery to the FEHBlog.

Also, Healthcare Dive informs us

Humana plans to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 through its second joint venture with private-equity firm Welsh, Carson, Anderson & Stowe, according to a Monday release from the payer.

The clinics will be managed and operated under Humana’s CenterWell Senior Primary Care brand, and WCAS will have majority ownership while Humana will have a minority stake.

The $1.2 billion expansion builds upon an existing venture with the same firm to open 67 clinics by early 2023.

From the Rx coverage front, Drug Channel reports on “The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22.”

I had the honor of presenting during the event’s general session: The Specialty Pharmacy Industry Update & Outlook. As in past years, I was joined by Doug Long from IQVIA. 

You can download our full slide deck here: https://drugch.nl/asembia22

From the mental healthcare front, Health Payer Intelligence discusses another angle considered in the UHG report on seniors mentioned above.

Over the last decade, seniors have experienced rising rates of mental healthcare needs, drug-related deaths, and early mortality, the UnitedHealth Foundation’s 2022 Senior Report shows.

“The 2022 Senior Report shows that the wellbeing of older adults was declining before the pandemic, which we know exacerbated many of these challenges,” Rhonda Randall, DO, executive vice president and chief medical officer of UnitedHealthcare Employer and Individual, said in the press release

“We urge people to help the seniors in your lives reconnect with the communities and activities they have enjoyed in the past but may not yet have returned to. We are focused on reducing disparities in the health care system for everyone, including older Americans.”

In webinar news — The Labor Department is holding a virtual event on May 25 concerning building mental health-friendly workplaces.

Monday Roundup

From the Omicron and siblings front —

  • Bloomberg observes “Covid hospitalitalization count makes vaccines seem less effective, Researchers say. The researchers point out that a patient who tests positive for Covid is a Covid hospitalization even if the patient is hospitalized for an unrelated reason.
  • In its recent review of Covid pills, the Institute for Clinical Review (ICER) gave a mildly favorable report on using an inexpensive anti-depressant fluvoxamine to treat Covid. This part of the ICER report was physician investigator-initiated. Those investigators sought FDA approval. Today, however, STAT News reports that “In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of the effectiveness of the drug, called fluvoxamine.” The investigators indicated that more fluvoxamine trials are ongoing as well as trials of other repurposed drugs.
  • The National Institutes of Health announced today that a research team is successfully using deidentified electronic health record data to better identify characteristics of persons with long Covid. “One reason long COVID is difficult to identify is that many of its symptoms are similar to those of other diseases and conditions. A better characterization of long COVID could lead to improved diagnoses and new therapeutic approaches.”
  • Roll Call delves into the use of wastewater surveillance to track Covid trends. Urban areas are good — rural areas are not so good.
  • Medpage Today offers an epidemiologist’s perspective on the occasionally observed Omicron rebound from Paxlovid, the Pfizer Covid pill. Reuters adds, “Pfizer has said that from more than 300,000 patients it is monitoring who received the 5-day treatment, around 1-in-3,000 – about 0.03% – reported a relapse after taking the pills.”

In other FDA news, MarketWatch informs us

The Food and Drug Administration on Monday authorized a test developed by Laboratory Corporation of America Holdings LH, -0.92% that allows people in the U.S. to self-test for respiratory syncytial virus (RSV), a type of common cold, as well as the flu and COVID-19. The test does not require a prescription. People swab at home and send the test by mail to a Labcorp lab. Results are then made available in an online portal. Teens and children are also authorized to test with the support of adults. The test kit costs $169 and may be covered by insurance, according to a spokesperson. It is expected to be available within the next three weeks. 

That’s helpful.

From the SDOH front —

  • Health Day informs us that “a new study shows that telemedicine has closed the gap in access to primary care between Black and non-Black Americans.”
  • Beckers Payers Issues tells us “Despite little change before the pandemic, the number of adults with medical debt, issues paying medical bills and medical debt in collections have declined since the pandemic began. New policies will be needed to sustain the decrease, according to a May 11 report from the Urban Institute.” 

From the preventive care front, Healio reports

A decrease in cervical cancer rates in the United States, most notably among younger women, may be associated with HPV vaccination approval, according to a retrospective, cross-sectional study published in JAMA Network Open

Researchers added that an increase in oropharyngeal and anal/rectal cancers, particularly among men, highlights a need for vaccination uptake among both men and women.

From the interoperability front, the Sequoia Project “selected by the Office of the National Coordinator for Health IT (ONC) as the Recognized Coordinating Entity (RCE) to support the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA), today released additional details regarding the process and requirements for becoming a Qualified Health Information Network (QHIN). The Sequoia Project is requesting feedback on these items before the final documents are released.” The Sequoia Project’s comment deadline is June 15, 2022, and “drafts are available on the RCE website.”

From the healthcare business front, Healthcare Dive reports

Hospitals’ labor costs rose by more than a third from pre-pandemic levels by March 2022, according to a report out Wednesday from Kaufman Hall.

Heightened temporary and traveling labor costs were a main contributor, with contract labor accounting for 11% of hospitals’ total labor expenses in 2022 compared to 2% in 2019, the report found.

Contract nurses’ median hourly wages rose 106% over the period, from $64 an hour to $132 an hour, while employed nurse wages increased 11%, from $35 an hour to $39 an hour, the report found.

In other government news —

  • The Department of Health and Human Service is marking the 10th anniversary of the National Plan to Address Alzheimer’s Disease. “HHS is commemorating the Anniversary through a series of publications and presentations highlighting the Department’s accomplishments in addressing Alzheimer’s disease and related dementias (ADRD), including those at the Centers for Disease Control and Prevention (CDC), Administration for Community Living (ACL), National Institutes of Health (NIH), Indian Health Service (IHS), and other HHS agencies. HHS will also sponsor a state policy roundtable to hear from state leaders about their work to address ADRD.  All events and materials will be shared on the 10th Anniversary HHS page.”
  • The Society for Human Resource Management relates that “An FAQ explains that the EEOC will permit employers to submit their EEO-1 Reports after the May 17 deadline, during what the agency is calling the “failure to file” phase. The EEOC stated, “All filers who have not submitted and certified their mandatory 2021 EEO-1 Component Report(s) by the Tuesday, May 17, 2022, published deadline will receive a notice of failure to file instructing them to submit and certify their data as soon as possible, and no later than Tuesday, June 21, 2022.”  All FEHB carriers must file this report.

Weekend update

The House of Representatives and the Senate to continue to be engaged in Committee business and floor voting this coming week.

From the omicron and siblings front, Bloomberg Prognosis reports

People who are vaccinated and then get infected with omicron may be primed to overcome a broad range of coronavirus variants, early research suggests.  

A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks.

The researchers have found the silver lining in the Omicron cloud.

In other encouraging healthcare news, BioPharma Dive informs us

The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients’ blood sugar and, potentially, help them lose weight as well.

Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other types of therapies. The company recorded $9 billion in diabetes drugs sales last year.

Mounjaro works by stimulating two hormones, called GLP-1 and GIP, that control insulin production. In clinical testing, the drug outperformed several other diabetes medicines, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was more effective in controlling blood sugar than two types of insulin as well. * * *

The drug’s approval will heighten competition between Lilly and Novo, which have battled for market share in the U.S. for years. Novo, for instance, has recently had success by launching a similar, once-weekly shot to Lilly’s top-selling drug Trulicity, as well as a daily pill that works the same way.

Novo is testing a dual-acting competitor to tirzepatide, but it’s only in Phase 2 testing, well behind Lilly’s drug. Both companies are also trying to develop a once-weekly insulin shot, with similar programs in Phase 3 development.

The next frontier for both companies is in obesity, where they are working to prove their drugs’ worth as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.

The article adds that Lilly did not disclose pricing for its newly approved drug on Friday.

The FEHBlog also noticed that Katie Keith’s latest article on the Affordable Care Act delves into the recent guidance on posting three machine reading pricing files on health plan websites by July 1. The discussion may be found in the closing paragraphs of the article.

Friday 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 weekly chart of new Covid cases from the 27th week of 2021 through the 19th week of 2022.

The CDC’s weekly review of its Covid statistics notes

As of May 11, 2022, the current 7-day moving average of daily new cases (84,778) increased 30.7% compared with the previous 7-day moving average (64,863). A total of 82,087,117 COVID-19 cases have been reported in the United States as of May 11, 2022.

Here’s the CDC’s weekly chart of new Covid hospitalizations

The CDC’s weekly review of Covid hospitalization notes, “The current 7-day daily average for May 4–10, 2022, was 2,629. This is a 17.5% increase from the prior 7-day average (2,238) from April 27–May 3, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths from the 27th week of 2021 through the 19th week of 2022:

The CDC’s weekly review notes “The current 7-day moving average of new deaths (273) has decreased 15.4% compared with the previous 7-day moving average (322). As of May 11, 2022, 996,376 COVID-19 deaths have been reported in the United States.”

Finally, here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era through the 19th week of 2022.

Per the CDC’s weekly review, “As of May 11, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 390,306, an 11.1% decrease from the previous week.”

76% of the U.S. population aged 18 and older are fully vaccinated against Covid, and 50% of that cadre has received the first booster. Likewise, 90% of the U.S. population aged 65 and older is fully vaccinated, and 70% of that cadre has received the first booster. There is work still to be done but the public health community and the U.S citizenry deserves credit for these accomplishments.

To wrap up this week’s Covid stats, let’s include the CDC’s latest Communities report:

As of May 12, 2022, there are 137 (4.25%) counties, districts, or territories with a high COVID-19 Community Level, 453 (14.07%) counties with a medium Community Level, and 2,630 (81.68%) counties with a low Community Level. This represents a small (+1.77 percentage points) increase in the number of high-level counties, a moderate (+4.10 percentage points) increase in the number of medium-level counties, and a corresponding (−5.87 percentage points) decrease in the number of low-level counties. Eight (15.38%) of 52 jurisdictions had no high- or medium-level counties this week.

To check your COVID-19 Community Level, visit COVID Data Tracker.

NPR Shots offers a valuable article describing three ways to get the Paxlovid pill if diagnosed with Covid. The key takeaway from the FEHBlog’s perspective is the need to have a primary care provider in your life.

For those with health insurance and access to their primary care providers or health care team, you can make an in-person or telehealth appointment to get tested (or share your positive test results), assessed for risks and medications and, if eligible, obtain a prescription for the pills. 

You’d then get the prescription filled at a nearby pharmacy

Having a provider that knows your medical history, as well as the details of your current situation, can be very helpful, says Dr. Ulrika Wigert, a family medicine physician at CentraCare in Sauk Center, Minnesota. “Did you test the first day [of symptoms]? Did you test the second day? How sick were you when you tested?” And, if you’re starting to feel better by the time you get the medication, do the benefits of taking the medication outweigh any risks? “Having a provider help navigate that on the individual patient basis” can help guide you through an appropriate course of care, she says. 

STAT News addresses three burning questions about the future of prescribing drugs using telehealth services (not for a PCP visit).

Research by Lori Uscher-Pines, a senior policy researcher at RAND, suggests that providers are starting to prescribe buprenorphine — a controlled substance used to treat opioid use disorder — without in-person visits. But they’re typically more comfortable continuing the prescriptions virtually for patients they’ve already met, compared to taking on new patients virtually.

Still, “very few studies of medication treatment for opioid use disorder via telehealth have shown safety or diversion concerns,” she said. And she noted that one recent study suggested that relaxed restrictions have improved treatment retention for opioid use disorder patients.

Telehealth prescription could help patients in regions with acute clinician shortages — especially of mental health providers — obtain critical medication.

“A key question going forward is how to strike a balance between increasing access to important medications on the one hand and limiting the potential for misuse on the other,” Uscher-Pines said.

In the past, federal and state regulations have required clinicians to frequently examine patients in-person to guard against misuse, addiction, or fraud. “But are there other ways to accomplish this, perhaps ways that actually leverage telehealth rather than restrict it?” she asked.

A better system might involve hybrid care: In-person exams for certain types of prescriptions blended with virtual follow-ups, for instance. But Schwamm cautioned against over-regulating telehealth prescriptions, given that clinical guidelines evolve faster than federal and state policies typically do.

“Whenever you put these kinds of restrictions in place, you are restricting access to care,” he said. “Do we need to require, and is it good medical practice, to require by regulation that the person come in-person? I would argue that we just don’t know.”

It’s complicated.

Thursday Miscellany

Photo by Josh Mills on Unsplash

The Hill reports

White House COVID-19 coordinator Dr. Ashish Jha issued a dire warning Thursday that the U.S. will be increasingly vulnerable to the coronavirus this fall and winter if Congress doesn’t swiftly approve new funding for more vaccines and treatments.

In an Associated Press interview, Jha said Americans’ immune protection from the virus is waning, the virus is adapting to be more contagious and booster doses for most people will be necessary — with the potential for enhanced protection from a new generation of shots.

STAT News offers this ray of sunshine

Epidemiologist David Dowdy of Johns Hopkins’ Bloomberg School of Public Health said that, despite the case increases, hospitalization and death rates overall remain relatively low compared with earlier periods in the pandemic — a reflection of how much immunity there is in the population.

“In some ways, this is encouraging, in that we’re starting to see a divergence between the number of cases and the number of hospitalizations and deaths,” Dowdy said. “But it’s also a little bit discouraging that we’ve been through all this and we’re still seeing a flat line and an uptick in the number of people getting admitted to the hospital and in people dying.”

In the FEHBlog’s view, the coordinator should stop fighting the Delta pandemic by focusing attention on better government distribution of Pfizer’s Paxlovid, which can cure the Omicron if taken timely. Kaiser Health News discusses this continuing and vexing distribution problem.

Unquestionably a need to focus attention on vaccinations and boosters remains essential. Govexec and Kaiser Health News ask why one-third of Americans over 65 have not received the first booster. Nearly all Americans over 65 are fully vaccinated. The article explains

People 65 and older account for about 75% of U.S. covid deaths. And some risk persists, even for seniors who have completed an initial two-dose series of the Moderna or Pfizer vaccine or gotten one dose of the Johnson & Johnson vaccine. Among older people who died of covid in January, 31% had completed a first vaccination round but had not been boosted, according to a KFF analysis of CDC data

FEHB plans are well-positioned to help with this effort, given their demographics.

In other virus news, the American Hospital Association tells us

The Centers for Disease Control and Prevention yesterday updated its testing guidance for clinicians treating children with hepatitis of unknown cause. The agency is investigating 109 potential hepatitis cases of unknown cause in U.S. children since last October, including five deaths. More than 90% of the patients were hospitalized, 14% received liver transplants and more than half had a confirmed adenovirus infection, but officials still don’t know the actual cause of their hepatitis and cautioned that it may take time to assess the evidence and learn more. Potential cases also have been reported in the United Kingdom and other countries. 

Following up on last night’s hospital system merger news, Healthcare Dive reports

The Advocate Aurora Health and Atrium Health merger is likely to get a close review from the Federal Trade Commission as the Biden administration has taken a tougher stance on healthcare consolidation, antitrust and legal experts say. * * *

“I don’t think anything of this size in a healthcare transaction today is going to get rubber stamped,” said Bill Horton, a partner at Jones Walker who focuses on healthcare transactions. * * *

“Historically, the FTC concern in hospital and healthcare institution mergers has been the geographic overlap,” Horton said.

Advocate Aurora and Atrium do not have any geographic market overlap. The systems span six separate states through the Midwest and South.

“It doesn’t raise the same red flags, but it doesn’t mean that it gets waved through,” said Leemore Dafny, a Harvard Business School professor and former deputy director of healthcare and antitrust at the FTC.

The FTC is likely to examine whether the two systems negotiate with the same insurers even if they’re in different geographic locations, Dafny said.

From the interoperability front, Health Data Management offers an interesting take on government efforts to meet lofty public health goals for Data Modernization Initiative.

From the mental health care front, and to end on a high note, Health Payer Intelligence informs us

Consumers reported having positive experiences with their employer-sponsored mental and behavioral healthcare coverage during the coronavirus pandemic, a survey conducted on behalf of AHIP discovered.

“Health insurance providers are working every day to support Americans by helping them find the mental health support and counseling they need at a price they can afford,” Matt Eyles, president and chief executive officer of AHIP, said in a press release.

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Capitol Hill, Roll Call reports

Third time’s a charm. Or so Democrats hope as they attempt to negotiate a third COVID-19 funding deal after their previous two bipartisan agreements — one for $15.6 billion in domestic and international aid, and a second for $10 billion in only domestic funds — stalled out. 

The House is taking the lead on the latest iteration. But it’s not yet clear whether they’ll hold out for a bipartisan, bicameral agreement or attempt to move a Democrat-led version that would provide more funding, closer to President Joe Biden’s original $22.5 billion request. 

“All the options are on the table,” House Majority Leader Steny H. Hoyer, D-Md., said Wednesday. “But it’s critical to get it done. And the fastest way to get it done is have an agreement on the four corners.” 

From the No Surprises Act front, the U.S. Court of Appeals for the Fifth Circuit has granted the federal government/appellant’s “unopposed motion to stay further proceedings in this court pending ongoing rulemaking proceedings involving provisions of the No Surprises Act, with a status report due every sixty (60) days.” It’s worth noting that the final independent dispute resolution rule has not yet appeared on the OMB’s Office of Regulatory Affairs reginfo.gov site.

From the Omicron and siblings front, Fierce Healthcare tells us

Reported cases of COVID-19 and hospitalizations for the disease are on the rise across most of the U.S., with the Centers for Disease Control and Prevention (CDC) recently shifting many counties in the Northeast to medium or high levels of community risk. * * *

COVID-19 hospitalizations—which have become the CDC and other public health experts’ preferred metric for decisionmaking—have similarly begun to tick upward over the past month.

After reaching a seven-day average low of 1,426 daily admissions in early April, national admissions have continually increased and exceeded the seven-day average of 2,400 daily hospitalizations late last week. These new admissions represented an 11% increase over the previous week’s seven-day average, according to the agency, but were still nearly 90% below the January peak of more than 21,500 average daily admissions.

From the opioid epidemic front, the Wall Street Journal reports

Drug-overdose deaths in 2021 topped 100,000 for the first time in a calendar year, federal data showed, a record high fueled by the spread of illicit forms of fentanyl throughout the country.

More than 107,000 people in the U.S. died from drug overdoses last year, preliminary Centers for Disease Control and Prevention data released Wednesday showed, roughly a 15% increase from 2020. The proliferation of the potent synthetic opioid fentanyl has been compounded by the destabilizing effects of the Covid-19 pandemic on users and people in recovery, according to health authorities and treatment providers. 

The U.S. has recorded more than one million overdose deaths since 2000, and more than half of those came in the past seven years. 

“We’ve never seen anything like this,” said Robert Anderson, chief of the mortality-statistics branch at the CDC’s National Center for Health Statistics, regarding fentanyl’s impact on the numbers.

From the telehealth front, Healthcare Dive informs us

Telehealth visits for COVID-19 diagnoses fell in February, mirroring the sharp decline in new cases of the virus reported to the Centers for Disease Control and Prevention after January’s omicron-driven peak, according to Fair Health’s monthly telehealth claims tracker.

Overall telehealth use also slowed, falling 9.3% in February across the country. Virtual visits were 4.9% of all medical claim lines, down from 5.4% in the prior month.

With declining COVID-19 cases generating fewer telehealth sessions, mental health conditions accounted for a greater share of all diagnoses conducted via virtual platforms, according to the Fair Health data released Monday. Mental health diagnoses rose to about 64% of telehealth claims, up from 60% in January.

The FEHBlog is happy that people are using telehealth for mental healthcare,e which strikes the FEHBlog as a good, productive fit.

From the healthcare business front, Healthcare Dive reports

Advocate Aurora Health and Atrium Health said Wednesday they plan to merge, creating one of the nation’s largest nonprofit health systems with $27 billion in combined revenues and 67 hospitals across six states.

Board members from both systems unanimously approved the agreement, which is subject to regulatory review. The combined entity will be led by both CEOs for the first 18 months, at which time Advocate’s CEO Jim Skogsbergh will retire, leaving Atrium’s CEO Eugene Woods as sole leader.

Advocate and Atrium will have an equal number of board seats. Atrium’s board chair Edward Brown will first serve as chair until the end of 2023, followed by a two-year term for Advocate’s chair Michele Richardson.

The health systems’ joint press release adds

The new organization will have a combined footprint across Illinois, Wisconsin, North Carolina, South Carolina, Georgia and Alabama. It will serve 5.5 million patients, operate more than 1,000 sites of care and 67 hospitals, employ more than 7,600 physicians and nearly 150,000 teammates, and have combined annual revenues of more than $27 billion.

That’s an interesting combination.

Health Payer Intelligence calls attention to

Six technology vendors [who] were highlighted for their abilities to address one of the six main points of friction between payers and providers that leading healthcare organizations strive to address, according to a KLAS report that is part of the KLAS Payer/Provider Initiative.

KLAS launched the Payer/Provider Initiative to identify points of friction between payers and providers and to highlight strong collaboration case studies.

The six payer-provider challenges that leading healthcare organizations tackled were prior authorization, value-based care, payer-provider interoperability, denials, credentialing, and patient billing.

From the OPM front, Federal News Network tells us

Agencies have to choose two out of four new focus areas to help improve their workforce over the next four years.

Deciding which options are most impactful gives agencies flexibility in how they approach new workforce objectives from the Office of Personnel Management.

Although OPM’s federal workforce priorities report, released on May 10, asks agencies to focus on only two of the four focus areas, implementing all four can help agencies resolve bigger workforce issues.

Among four primary priorities and four enabling priorities, OPM hopes agencies can implement proactive approaches to common issues, such as recruitment challenges.

From OPM’s federal workforce priorities report via Federal News Network

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

  • The Wall Street Journal has updated its article on Covid boosters.
  • The Institute for Clinical and Economic Review (ICER) today released “a Final Evidence Report assessing the comparative clinical effectiveness and value of [specific] outpatient treatments for COVID-19 [, principally Pfizer’s pill Paxlovid and Merck’s pill molnupiravir ].

A majority (11-2) found current evidence is not adequate to demonstrate a net health benefit when molnupiravir is compared to symptomatic care alone.

All panelists (13-0) found that current evidence is adequate to demonstrate a net health benefit when Paxlovid is compared to symptomatic care alone.

Due to uncertainty in the net health benefit for molnupiravir, a majority of panelists voted that it represents “low-to-intermediate” long-term value for money.

A majority of panelists found that Paxlovid represents “high” long-term value for money.

  • ICER presented at the OPM/AHIP carrier conference last month. ICER “is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.”
  • Speaking of the Covid pills, STAT News discusses the use of telehealth services to prescribe them. The upshot, as the FEHBlog understands it, is while using telehealth for this purpose is convenient for patients, experts are unsure whether the telehealth service provides adequate follow-up care to the patient.

Also, from the Rx coverage front, the Food and Drug Administration issued a news roundup today.

From the healthcare business front, BioPharma Dive reports

Pfizer has agreed to acquire Biohaven Pharmaceuticals for $11.6 billion in a deal that turns an existing alliance on a fast-selling migraine drug into a big bet on its future growth.

Pfizer will pay $148.50 per share in cash for each Biohaven share it doesn’t already own, representing a roughly 79% premium to the company’s Monday closing price and a 33% premium to its average share price of $111.70 over the last three months. The deal, which is expected to close early next year, is by far the biggest biotech buyout of 2022, according to data compiled by Biopharma Dive.

Announced Tuesday, the acquisition hands Pfizer full rights to Nurtec ODT, a pill that’s approved in the U.S. and other countries for the treatment and prevention of migraines. Biohaven’s pipeline also includes an experimental nasal spray for migraines, zavepegant, that’s been submitted to U.S. regulators, as well as five additional, preclinical treatments that block the same protein target.

From the mental health parity front, the Labor Department’s Employee Benefits Security Administration announced that the agency will be holding a mental health parity compliance assistance webcast on May 24 from 2-3 pm ET. Here is a link to the announcement which explains how to register for the webcast.

From the patient safety front, the Leapfrog Group “released the spring 2022 Leapfrog Hospital Safety Grade, which assigns a letter grade to nearly 3,000 U.S. general hospitals based on over 30 measures of patient safety.”

At HospitalSafetyGrade.org, the public can find detailed information about a hospital’s performance on patient experience and other safety measures used to grade hospitals.

Across all states, highlights of findings from the spring 2022 Leapfrog Hospital Safety Grade include:

Thirty‐three percent of hospitals received an “A,” 24% received a “B,” 36% received a “C,” 7% received a “D,” and less than 1% received an “F.”

Five states with the highest percentages of “A” hospitals are North Carolina, Virginia, Utah, Colorado, and Michigan.

There were no “A” hospitals in Wyoming, West Virginia, the District of Columbia, or North Dakota.

From the medical research department, Medscape informs us

Eight modifiable risk factors were linked to more than one in three cases of Alzheimer’s disease and related dementia in the U.S., a cross-sectional analysis showed.

The eight risk factors — midlife obesity, midlife hypertension, physical inactivity, depression, smoking, low education, diabetes, and hearing loss — were associated with 36.9% (95% CI 36.5-37.3) of Alzheimer’s and dementia cases, reported Roch Nianogo, MD, PhD, of the University of California Los Angeles, and Deborah Barnes, PhD, MPH, of the University of California San Francisco, and co-authors.

The factors most prominently associated with Alzheimer’s and dementia were midlife obesity, at 17.7% (95% [Confidence Interval] CI 17.5-18.0); physical inactivity, at 11.8% (95% CI 11.7-11.9); and low educational attainment, at 11.7% (95% CI 11.5-12.0).

“We published a similar study a little more than 10 years ago, and the most important risk factors then were physical inactivity, depression, and smoking,” Barnes told MedPage Today.

“Today, the top three risk factors are midlife obesity, physical inactivity, and low education,” she observed. “This is important because it suggests that the growing number of people who are obese in the U.S. could have a major long-term impact on dementia rates.”

From the clarification front, the FEHBlog often reminds folks that federal employees who retired under the Civil Service Retirement System before 1984 are not eligible for free Medicare Part A. The FEHBlog dug into this issue today, and he discovered this 2013 Reg Jones Q&A on this topic that the Federal Times published.

Q. I retired in 2009 under CSRS. I am close to 65, and the answer to one of the questions asked states that people in CSRS are not eligible for Medicare because they didn’t pay into Social Security.

I was in CSRS before the change to FERS and stayed with CSRS. I had Medicare deductions taken from my pay from 1983-84 till I retired in 2009.

Do the Medicare funds I paid since 1983 make me eligible for Medicare or just part of it?

So which is right? I need to know so I can do what needs to be done — enroll or not. I’m currently insured under federal BCBS.

A. CSRS employees who retired before Dec. 31, 1983, aren’t eligible for Medicare Part A. Nor are CSRS employees who retired after that date but before having Medicare deductions taken from their pay for 10 years.

On the other hand, they are eligible to enroll in Medicare Part B, which is open to everyone 65 or older.

Consequently, the cadre of 65 and older federal annuitants without Medicare A is larger than the FEHBlog understood. This cadre is relevant to the Postal Reform Act because that law keeps Postal annuitants over aged 65 without Medicare Part in the legacy FEHBP.