Monday Roundup

Congress

Monday Roundup

David Ermer–Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Medpage Today suggests that prior authorization practices are under Congress’s spotlight.

From the Omicron and siblings front–

  • The Wall Street Journal offers an interesting report on the ups and downs of Omicron and its siblings.
  • Govexec tells us about recent Safer Federal Workforce changes to “its COVID-19 protocols to draw more distinctions between the policies for vaccinated and unvaccinated workers, including those related to travel and paid leave.”

From the federal employment front, the Society for Human Resource Management explains how the federal government is “struggling mightily to recruit, retain and develop the talent it needs to succeed and earn the reputation of being a “model employer.” Agencies and their HR leaders are working to upgrade antiquated systems and processes. The new-hire process currently takes an average of 100 days to complete, double that of the private sector.” Good luck.

From the Rx coverage front, Prime Therapeutics announced last week

Leading pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime) analyzed its real-world data to assess clinical outcomes and drug waste differences between medically integrated dispensing (MID) and central specialty pharmacy dispensing of oral cancer therapies. This study of a Prime pilot program showed a potential average savings opportunity of $1,800 per medication dose change at a MID pharmacy compared to a central fill specialty pharmacy. Results reinforced Prime’s position of the advantages of the MID model, on which its IntegratedRx™ program is based.

With the MID model, care providers – including doctors and pharmacists – have access to prescribing history, test results and other important patient information in the EMR. This coordination informs the care team earlier than the traditional model. This early look has potential to help lower the number of 30-day prescriptions going to waste.

Prime’s MID pilot program was implemented in early 2021 within three oncology practices and across three Blue Plans’ commercially insured lives to prove the potential care and cost advantages with this distinct model compared to a centralized specialty pharmacy model. Study participants were prescribed oral drugs that did not require dispensing and shipment from a payer-directed specialty pharmacy to the oncologist (aka white bagging).

From the studies department —

  • Health Payer Intelligence informs us “More consumers reported that their health plans are offering transparency tools and overall consumer awareness about the availability of transparency tools has grown, according to a study conducted on behalf of HealthSparq.”
  • MedPage Today discusses a study finding that weight loss, even when achieved by bariatric surgery, will reduce the risk of obesity-related cancer. The FEHBlog wonders if weight loss produced by the current, effective weight loss drugs would have a similar health impact.
  • mHealth Intelligence notes that “To reduce the amount of time spent in a virtual waiting room, researchers from the University of California San Diego conducted a pilot that used text messaging to provide patients with a meeting link when their provider was ready to see them, finding it to be a successful alternative.”
  • The New York Times reports on a GlaxoSmithKline “checkpoint inhibitor” drug trial conducted on eighteen rectal cancer patients. The drug wiped out the cancer in all of those patients. Quite amazing. According to the Times experts indicate that the trial needs to be replicated.
  • BioPharma Dive reports “Twenty-four years ago, a drug called Herceptin changed how doctors treat breast cancer. Its approval in 1998 made it possible to target the aggressive breast tumors tied to a gene called HER2. Other drugs quickly followed Herceptin and, over the years since, have substantially improved survival for people with the disease. A quarter of a century later, another shift in treatment could be on the horizon. At the American Society of Clinical Oncology meeting, AstraZeneca and Daiichi Sankyo are presenting results proving that, for the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2. Clinical trial data revealed at ASCO and published in The New England Journal of Medicine Sunday show the drug, Enhertu, halved the risk of cancer progression compared to chemotherapy and reduced the risk of death by 36%.”
  • The Guardian tells us “Taller people have an increased risk of peripheral neuropathy, as well as skin and bone infections, but a lower risk of heart disease, high blood pressure and high cholesterol, according to the world’s largest study of height and disease. A person’s height raises and reduces their risk of a variety of diseases, according to the research led by Sridharan Raghavan of the Rocky Mountain Regional VA Medical Center in the US. The findings are published in the journal PLOS Genetics.”

From the potpourri department, check out this NIH Newsletter for June 2022.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, SCOTUS, Telehealth, U.S. Healthcare–

Congress is back on Capitol Hill this week for floor voting and Committee business. Roll Call notes

Lawmakers return next week for a busy June, with Senate Republicans tested by politically wrought gun talks and President Joe Biden dealing with a spate of crises and headaches.

The Hill identifies the five “looming disputes” out of 33 pending disputes that the Supreme Court is expected to decide this month which typically is the last month of its October 2021 Term. Although not found among the Hill’s cases, here’s a Medicare secondary payer act case that has not been decided yet and could impact FEHBP.

Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc., No. 20-1641 [Arg: 03.1.2022 Trans./Aud.] 

Issue(s): (1) Whether a group health plan that provides uniform reimbursement of all dialysis treatments observe the prohibition provided by the Medicare Secondary Payer Act that group health plans may not “take into account” the fact that a plan participant with end stage renal disease is eligible for Medicare benefits; (2) whether a plan that provides the same dialysis benefits to all plan participants, and reimburses dialysis providers uniformly regardless of whether the patient has end stage renal disease, observe the prohibition under the Medicare Secondary Payer Act that a group health plan also may not “differentiate” between individuals with end stage renal disease and others “in the benefits it provides”; and (3) whether the Medicare Secondary Payer Act is a coordination-of-benefits measure designed to protect Medicare, not an antidiscrimination law designed to protect certain providers from alleged disparate impact of uniform treatment.

From the Omicron and siblings front —

The Wall Street Journal reports

The latest Covid-19 wave in the U.S. has shifted westward, hitting places like the San Francisco area, while pressure eases in recent Northeast hot spots.

The Western U.S. region, which includes mountain and coastal states, has recently eclipsed the Northeast to have the nation’s highest rate of known cases per 100,000 people, a Wall Street Journal analysis of CDC data shows. Recent increases in parts of the West come amid declines in the Northeast.

NPR Shots provides more background on the Novovax Covid vaccine that the FDA advisory committee will consider for emergency use authorization this Tuesday. NPR Shots adds

The federal government is trying to decide what kind of booster people should get in the fall to try to blunt the severity of a possible new wave of infections next winter. The panel of FDA advisers will meet late this month to consider which strains of the coronavirus should be targeted by updated vaccines.

From the mental health coverage front, the American Hospital Association released a TrendWatch about the pandemic’s adverse impact on mental health. Also, Healthcare Dive informs us that while telehealth use dropped in February and March 2022, according to a Fair Health study,

Teletherapy continued to remain robust, snagging the top procedure spot for telehealth visits in March and representing 26% of virtual claim lines, the report noted. Mental health conditions claimed 65% of diagnoses across all regions. Likewise, social workers remained the most popular specialty in telehealth claims for the second month in a row.

From the value-based care front, Health Payer Intelligence discusses how payers can move providers away from fee-for-service contracts to value-based contracts. It’s worth a read.

Midweek update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–

From Capitol Hill, A bipartisan PBM transparency bill was introduced by Senators Maria Cantwell (D Wash) and Charles Grassley (R Iowa) last week.

Sens. Chuck Grassley (R-Iowa), ranking member of the Judiciary Committee, and Maria Cantwell (D-Wash.), chair of the Committee on Commerce, Science and Transportation, have introduced legislation that would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.

The Pharmacy Benefit Manager Transparency Act of 2022 would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.

Healthcare Dive reports on a recent study supporting the goals of this bill.

From the Omicron and siblings front

Bloomberg Prognosis informs us

Turns out a third dose of messenger RNA vaccine provides a key boost to immunity against Covid regardless of the original shot.

That’s what scientists from the Chinese University of Hong Kong found after scouring 53 studies that contained at least 24 different vaccine regimens. 

Three mRNA doses offered the best protection against infection, the researchers found, though just one of those shots as a booster after other types of Covid-19 vaccines worked almost as well. 

The Wall Street Journal tells us

Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to authorize three doses of their vaccine for children under 5 years.

The request Wednesday to the Food and Drug Administration comes after the companies said last month that three doses of the shot were 80% effective at preventing symptomatic Covid-19 and generated a robust immune response in children ages 6 months to 5 years old.

The Pfizer-BioNTech vaccine was also found to be safe and well-tolerated among the children in studies, according to the companies.

FDA clearance could come before the end of the month. If the Centers for Disease Control and Prevention signs off, the last remaining group of people in the U.S.—roughly 19 million young children—would get access to shots at doctors’ offices, pharmacies and other locations.

The FDA is scheduled to consider the Pfizer and Moderna emergency authorization requests for mRNA Covid vaccinations for children aged six months to five years.

The National Institutes of Health reveals

A National Institutes of Health-funded study has found that people with food allergies are less likely to become infected with SARS-CoV-2, the virus that causes COVID-19, than people without them. In addition, while previous research identified obesity as a risk factor for severe COVID-19, the new study has identified obesity and high body mass index (BMI) as associated with increased risk for SARS-CoV-2 infection. In contrast, the study determined that asthma does not increase risk for SARS-CoV-2 infection.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study also found that children ages 12 years or younger are just as likely to become infected with the virus as teenagers and adults, but 75% of infections in children are asymptomatic. In addition, the study confirmed that SARS-CoV-2 transmission within households with children is high. These findings were published today in the Journal of Allergy and Clinical Immunology.

From the healthcare business front

Fierce Healthcare reports

Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday.

Sources told the news outlet that the purchase from Webster Equity Partners would earn HCAT a $300 million enterprise value and earnings before interest, taxes, depreciation and amortization in the high teens. UnitedHealth Group, Optum’s parent company, has made overtures to purchase HCAT in the past, according to the report.

HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.

Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.

N.B. The FEHBlog is in Dallas today!

Fierce Biotech tells us

GSK is betting big to reenergize its fight for a share of the pneumococcal vaccine market, agreeing to pay $2.1 billion upfront to acquire Affinivax for a challenger to Pfizer’s blockbuster Prevnar franchise.

The British Big Pharma already has an approved pneumococcal vaccine, Synflorix, but has failed to turn it into a true rival to Pfizer’s incumbent. Sales of Synflorix fell (PDF) to 357 million pounds sterling ($450 million) last year, while the Prevnar range of vaccines still topped (PDF) $5 billion in the face of COVID-related headwinds and the timing of government purchases. Last year’s approval of Merck & Co.’s Vaxneuvance further intensified competition. 

From the studies department

  • Forbes informs us “The U.S. spends twice as much on cancer care than average for high-income countries but mortality rates are only slightly better than average for these countries, according to a new study.”
  • Fierce Healthcare reports on a Kaiser Family News projection of 2022 insurer rebates required by the Affordable Care Act.

Kaiser’s analysis—which is based on data reported by insurers to state regulators—predicts that individual market insurers will have to pay out $603 million in rebates for 2022, with small group markets sending out $275.5 million and $168.1 million for large group plans. The final rates will be released later this year.

The $603 million for individual market plans, which includes the ACA’s exchanges, is far below the $1.3 billion in rebates for 2021 and $1.7 billion for 2020. 

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, STAT News reports

The sweeping FDA funding bill unveiled by senators Friday would direct the FDA to stand up an “intra-agency coordinating council” to oversee its use of the controversial accelerated approval pathway, my colleague Lev Facher writes. The policy seems a clear response to the controversy over the FDA’s approval of Aduhelm — and it’s the latest sign that lawmakers are within striking distance of reforming the controversial pathway, which allows the FDA to greenlight drugs without clear evidence they extend patients’ lives. 

Accelerated approval not your bailiwick? There’s plenty more in the 433-page bill too, including a proposal from Sen. Elizabeth Warren that would force the FDA to finally release regulations meant to lower the cost of hearing aids. Conspicuously missing from the legislation? Any of the House’s proposals on clinical trial diversity. 

For more on the package, check out Lev’s story here. 

From the Omicron and siblings front

AP tells us

The coronavirus mutant [BA 2.12.1] that is now dominant in the United States is a member of the omicron family but scientists say it spreads faster than its omicron predecessors, is adept at escaping immunity and might possibly cause more serious disease.

Why? Because it combines properties of both omicron and delta, the nation’s dominant variant in the middle of last year. 

A genetic trait that harkens back to the pandemic’s past, known as a “delta mutation,” appears to allow the virus “to escape pre-existing immunity from vaccination and prior infection, especially if you were infected in the omicron wave,” said Dr. Wesley Long, a pathologist at Houston Methodist in Texas. That’s because the original omicron strain that swept the world didn’t have the mutation.

Tricky little devil.

The Wall Street Journal adds that

Most people with Covid-19 will still test positive on a rapid test at five days, and a “fairly large percentage” test positive after 10 days, CDC spokeswoman Jasmine Reed said. Infectiousness drops significantly at eight days, with few people remaining contagious at 10 days, she said. 

The CDC guidance also takes symptoms into account as a factor to gauge contagiousness, she said, noting that people should only leave isolation after five days if their symptoms are improving. The CDC recommends that everyone wear a well-fitted mask and avoid travel and being around high-risk people for 10 days, no matter when the person leaves isolation. * * *

At the beginning of an infection, when a person’s viral load is rising, it might take a few days before tests turn positive. That is why health authorities recommend that people with symptoms and negative rapid-test results wait and retest or get a more sensitive lab-based PCR test.

As a person’s viral load drops, rapid tests are a better indicator of who is no longer infectious, public-health experts said. * * *

Immunocompromised people and those who get severely ill can be contagious even longer than 10 days, studies suggest, and patients who experience rebounding symptoms or who test positive again after taking Pfizer Inc.’s Paxlovid pill should also assume that they are contagious, infectious-disease experts said.

David Leonhardt writes about the benefits of one-way masking in his New York Times column today. “Because masks work and mandates often don’t, people can make their own decisions. Anybody who wants to wear a snug, high-quality mask can do so and will be less likely to contract Covid.” That makes sense to the FEHBlog.

In healthcare business new, the American Hospital Association informs us

According to a report by Kaufman Hall, hospitals faced decreases in both patient volume and revenue in April. Year-to-date hospitals have struggled to rebound from winter surges and new spikes in COVID-19. Median operating margins declined for the fourth straight month with patient volume down 6.5%, revenue down 7%, and expenses continued to climb well above pre-pandemic levels and 9.6% year-to-date higher than 2021.

Healthcare Dive reports

* In its latest earnings report, Change Healthcare highlighted its momentum heading into the next fiscal year, outlining what 2023 could look like for the data analytics company as a standalone business in the event its controversial $13 billion merger with UnitedHealth falls through.

* In previous quarters, Change has not provided formal forward-looking guidance given the pending transaction. But in fourth-quarter results released last week, Change said it expects between 2% to 4% growth in its core Solutions business in 2023, moderately below analysts’ consensus, and roughly flat earnings before interest, taxes, depreciation and amortization margins.

* Change noted the flat margins are due to some wage pressure, lower volume-driven revenues as COVID-19 cases drop and client attrition due to its proposed merger with UnitedHealth’s health services arm, Optum. 

The trial over the Justice Department’s challenge to this merger begins in August.

In public health news Medscape explains

Each day between 2017 and 2019, nearly 2,300 adolescents and young adults became new daily tobacco users — a figure that mirrors statistics from 1989 to 1993.

According to a longitudinal study, the total number of daily vape (or e-cigarette) users under 21 years of age rose to more than 1 million by 2019. Of those, 56.3% used Juul products in particular, reported cancer prevention researcher John Pierce, PhD, of the University of California San Diego in La Jolla, and colleagues in Pediatrics.

“The large increase in daily use among U.S. adolescents could presage future health consequences and needs urgent additional action from the [FDA],” the authors wrote.

From the mental health coverage front, the Society for Human Resources Management discusses how employers are grappling with a surge in employee mental health issues.

Also the Biden Administration marks the end of mental health awareness month by listing its accomplishments and plans, including

In addition to facilitating access to comprehensive telebehavioral health benefits through the Federal Employees Health Benefits Program, the Office of Personnel Management (OPM) is working to reinvigorate Employee Assistance Programs provided by all federal agencies to better meet employees’ behavioral health needs, while disseminating best practices and new ideas for improving federal workplace mental health.

From the medical research front, STAT News reports

Bay Area biotech Ultima Genomics on Tuesday claimed that its technology can sequence a whole human genome for $100, making it a surprise player in the race to read DNA quickly, accurately, and cheaply.

The company didn’t provide specifics or immediately reply to an inquiry from STAT as to how it calculated that cost. But a $100 genome would represent a major drop in price, one that could help researchers unlock sequencing’s potential to unravel the mysteries of undiagnosed diseases, spot early signs of cancer, and better understand human health. That’s because while the cost of reading a full human genome has plummeted from around $95 million in 2001 to about $560 in 2021, according to the National Human Genome Research Institute, sequencing is still too pricey to be routinely used in health care and research.

That’s an intriguing development.

Memorial Day Weekend Update

David Ermer–CDC, Congress, COVID-19, Patient safety, U.S. Healthcare, Uncategorized–
Photo of a Fallen or Missing Comrades Table
by Selena Morar on Unsplash

Today as we remember those who have fallen for our Country, let’s also note that today is the 100th anniversary of the dedication of the Lincoln Memorial located on the Mall in Washington DC.

The Senate and the House of Representatives are holding a State / District work period this week. Insurance News Net adds that the House Oversight and Reform Committee has “requested information regarding insurers’ and PBMs’ compliance with the ACA and CMS guidance [on contraceptive coverage] by June 8, 2022.

From the Omicron and siblings front —

The Wall Street Journal reports

Pfizer’s antiviral drug, called Paxlovid, totaled more than 412,000 prescriptions through May 6, compared with about 110,000 prescriptions of molnupiravir, an antiviral from Merck & Co. and Ridgeback Biotherapeutics LP [called Lagevrio], according to drug-data firm Iqvia Holdings Inc. * * *

“Now that Paxlovid has become much easier to obtain, by and large relative to where it was before, Paxlovid is mine and the majority of my colleagues’ first choice,” said Ali Khan, chief medical officer of value-based strategy at Oak Street Health Inc., which has more than 140 primary-care clinics in 20 states across the U.S. * * *

“Doctors have become more comfortable with Paxlovid and more regularly prescribing the more effective drug,” said Zenobia Brown, medical director of health solutions at Northwell Health, a major New York healthcare provider.

Paxlovid, like Lagevrio, has been shown through lab studies to remain effective against Omicron and its subvariants. That has allowed doctors to prescribe it and reserve antibody treatments for other people who can’t take Paxlovid because of the potentially harmful drug interactions.

Federal News Network tells us

The White House earlier this month announced that households can now order a third round of free COVID-19 rapid tests on COVIDTest.gov.

Households can now receive eight new tests, double what households could order in the previous two rounds. USPS has delivered at least 380 million free tests through the program so far.

Bravo, USPS.

From the unusual viruses front —

  • STAT News updates us on monkeypox. “The ongoing monkeypox outbreak currently poses a moderate risk to global public health, the World Health Organization said Sunday in a statement that nevertheless raised the specter of the virus becoming entrenched as a pathogen that spreads from person to person. * * * To date most of the [257 confirmed] cases have been diagnosed in Europe and North America. The United States had detected 12 cases as of Friday. “Currently, the overall public health risk at [a] global level is assessed as moderate considering this is the first time that monkeyp ox cases and clusters are reported concurrently in widely disparate WHO geographical areas,” the global health agency said.”
  • The World Health Organization updates us on “Six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children [that] have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The majority of reported cases (n=374; 58%) are from the WHO European Region (22 countries), with 222 (34%) cases from the United Kingdom of Great Britiain and Northern Ireland alone. Probable cases and cases pending classification have also been reported from the Region of the Americas (n=240, including 216 cases in the United States of America) * * *.

From the miscellany department

  • The American Medical Association offers an article about what doctors wish their patients knew about living with migraines.
  • MedPage Today informs us “Using artificial intelligence (AI) during screening colonoscopy could be a cost-savings strategy that also could boost the prevention of colorectal cancer (CRC) incidence and mortality, a researcher reported.”
  • MedPage also tells us “Physical therapy-based rehabilitation frequently leads to better outcomes using fewer resources for patients with MSK pain when compared to operative procedures. But physical therapy must be a part of the treatment conversation early on, while surgery should be positioned as a last resort with the patient made well aware of surgery’s risks and complications. This is currently not the case in many patient-provider interactions.”

Thursday Miscellany

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

From Capitol Hill, Roll Call reports

Lawmakers are facing increased pressure to pass a comprehensive mental health and substance use package but are unlikely to make an initial goal of advancing legislation before the implementation of a three-digit suicide hotline in July.

At least four congressional committees have committed to advancing a swath of bipartisan mental health bills under their jurisdiction, but lawmakers have not yet unlocked the puzzle of how to incorporate a growing laundry list of programs to authorize and establish existing and new programs dedicated to treatment, prevention, education, crisis care, drug interdiction and the workforce.

One of those four committees is the Senate Finance Committee which announced today

Senate Finance Committee Chair Ron Wyden (D-Ore.), Ranking Member Mike Crapo (R-Idaho), Senator Ben Cardin (D-Md.) and Senator John Thune (R-S.D.) today released a discussion draft for telehealth policies as a part of the committee’s ongoing work to improve mental health care across the nation, which has included a public call for comments and three hearings to help develop these initiatives. * * *

The discussion draft includes policies that would:

* Remove Medicare’s in-person visit requirement for tele-mental health services.

* Establish benefit transparency for mental health care services delivered via telehealth to inform Americans with Medicare how and when they can access telehealth.

* Preserve access to audio-only mental health coverage in Medicare when necessary and appropriate.

* Direct Medicare and Medicaid to promote and support provider use of telehealth.

* Incentivize states to use their CHIP programs to establish local solutions to serve behavioral health needs in schools, including through telehealth.

From the Omicron and siblings front

Beckers Hospital Review informs us

A highly contagious sublineage of the BA.2 omicron subvariant is now the nation’s dominant strain, according to the CDC’s latest variant proportion estimates. 

The sublineage, BA.2.12.1, accounted for 57.9 percent of all U.S. COVID-19 cases in the week ending May 21, CDC data shows. BA.2, which became the nation’s dominant strain in mid-March, now accounts for an estimated 39.1 percent of all cases.

BA.2.12.1 is estimated to have a 25 percent growth advantage over BA.2, which is already more transmissible than the original omicron strain. The newer omicron sublineage has been gaining traction in the U.S. over the last month. In the week ending April 23, BA.2.12.1 accounted for just 24.1 percent of U.S. COVID-19 cases. 

Health officials are also monitoring another omicron subvariant — BA.1.1.529 — which currently accounts for an estimated 2.8 percent of cases.  

“Epidemiologically, it doesn’t appear as if we’re seeing more severe disease in places that are having more cases,” CDC Director Rochelle Walensky said of the sublineages during an April 26 news conference. “So we are not anticipating more severe disease from some of these subvariants, but we are actively studying it.”

CBS News reports

As many as one in four seniors and one in five adults under 65 experienced “long COVID” or “post-COVID” symptoms after surviving a coronavirus infection, a new study from the Centers for Disease Control and Prevention reported Tuesday. 

The study — published in the CDC’s Morbidity and Mortality Weekly Report — is the latest to try and quantify how many of the millions of Americans who have now tested positive for the virus are facing long-term issues caused by their infection. 

By comparing electronic health records in a large national database of patients, the study’s authors found 38.2% of COVID-19 survivors “experienced at least one incident condition” — a list that includes heart, lung, kidney and gastrointestinal problems, pain, fatigue, loss of smell or taste, mental health issues, and more —  in the months after their infection. By contrast, just 16% of other people were diagnosed with such conditions.

The Wall Street Journal adds

Vaccination reduces your risk of developing long Covid, but not by much on average, new research suggests. 

A Veterans Affairs study out Wednesday found that vaccinated people with breakthrough Covid-19 infections had a 15% reduction in experiencing persistent or new symptoms and health conditions up to six months after infection compared with those who were unvaccinated and got Covid. 

Most of the vaccinated people had received two doses of the Pfizer or Moderna vaccine, while 8% received one dose of the Johnson & Johnson vaccine. The study didn’t look at people who had received boosters.

Bloomberg discusses the risks of contracting Covid while pregnant.

Canada’s first dual specialist in infectious diseases and obstetrics/gynecology, Deborah Money, MD comments “For the most part, women in communities even with Covid circulating do well,” she says. “The majority of babies are fine.”

But that’s just part of the story. Their analysis of data from 6,012 people in six Canadian provinces who tested positive for the virus during their pregnancy found a substantial increase in hospitalizations and ICU admissions compared with reproductive-age, non-pregnant females infected with the coronavirus. Their study in the May 2 issue of the JAMA medical journal also found that 11.1% of Covid–affected pregnancies resulted in preterm birth, compared with 6.8% among all unaffected Canadian pregnancies. * * *

Money says it underscores the need for obstetricians to carefully monitor their pregnant patients who become infected with SARS-CoV-2, and for expecting moms to get vaccinated and boosted.

“That’s the biggest thing they can do,” she says. “It really does look like vaccine is preventative for the serious outcomes.” 

From the studies front —

  • The Medical Group Management Association informs us “Despite multiple waves of disruption in 2021, medical practices navigated through the “new normal” of COVID-19 to restore a sense of normalcy in productivity and compensation last year.”
  • Milliman released its 2022 Medical Index (MMI). “In 2022, the cost of healthcare for a hypothetical American family of four covered by an average employer sponsored PPO plan is $30,260,” 4.6% above 2021.
  • HR Dive tells us “[a] 2019 IRS notice expanded the list of medications and health services Health Savings Account-eligible health plans may cover prior to meeting a patient’s deductible. Employers that take advantage of the expansion could cover these treatments with little to no increases in patient premiums, according to an Employee Benefits Research Institute report published May 19.”

Commercial insurance members’ satisfaction with their plans stayed flat between 2021 and 2022, according to a new survey from J.D. Power.

Satisfaction was on a steady climb over the past five years, the survey found, but plateaued in the past year amid declines in how well members’ expectations for customer service were met and dissatisfaction with their plan designs and network providers.

Health plans that were perceived by members as responsive enjoyed higher scores than those that were not, J.D. Power found. The Kaiser Foundation Health Plan and regional Blues insurers were consistently ranked as the highest scoring in the study’s 22 geographic regions.

From the mental healthcare front, the International Foundation of Employee Benefit Plans notes

The U.S. Department of Labor (DOL) published new guidance on obtaining job protected leave under the Family and Medical Leave Act (FMLA) for workers seeking mental health support. The guidance clarifies that eligible employees are able to take FMLA leave for their own serious health condition or to care for a spouse, child or parent because of their serious health condition, and that a serious health condition can include a mental health condition.

The guidance includes:

* Fact Sheet #28O: Mental Health Conditions and the FMLA, and

* Frequently Asked Questions on the FMLA’s mental health provision

From the federal employee benefits front, benefits consultant Tammy Flanagan writes in Govexec about Federal Employee Group Life Insurance Program options for federal and postal annuitants. What’s more, Fedweek explains how FEHBP fills Medicare coverage gaps for those fine folks.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, NIH, No Surprises Act, U.S. Healthcare–
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

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.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID-19, Federal employment benefits, Medicare, Mental health care, OPM–

From Capitol Hill, The Hill informs us

Photo by Josh Mills on Unsplash

A growing number of Senate Democrats say they’re ready to take a tough vote on an amendment to keep the Title 42 health order in place at the U.S.-Mexico border if that’s what’s needed to move a stalled COVID-19 relief package. 

Senate Majority Leader Charles Schumer (D-N.Y.) has held the bill from the floor because Republicans are insisting on voting on a bipartisan amendment to overrule the Biden administration’s decision to lift Title 42, a pandemic order that has stopped thousands of immigrants from entering the country on asylum claims.   * * *

Without giving in to the Republicans’ demand for a vote on the hot-button issue of securing the border, COVID-19 relief could be stalled until after the November election.  

The amendment is expected to fail but it’s a tough vote for vulnerable Senate Democrats. 

More likely, in the FEHBlog’s view, the Majority Leader is waiting until the Title 42 health order is lifted later this month to see what happens.

From the Omicron and siblings front —

The Wall Street Journal informs us

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized Covid-19 booster shot from Pfizer Inc. and BioNTech SE.

Following the recommendation Thursday, many of the nation’s doctors, pharmacies and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children in the age group.

The shots are to be given five months after the second dose. The extra dose is one-third the amount that those 12 years old and above receive.

Also Thursday, the CDC said it was strengthening its recommendation that people 12 years and older who are immunocompromised, or who are 50 and older, should receive a second booster dose at least four months after their first.

This means that health plans must start covering the booster with no member cost-sharing pursuant to ACA FAQ 50.

The Journal adds

Moderna Inc.’s leader said it is possible the company would be able to start shipping its Covid-19 vaccine for use in young children as soon as early June, pending a decision by U.S. regulators.

“We are ready from a manufacturing standpoint,” Moderna Chief Executive Stéphane Bancel said during a virtual appearance Thursday at The Wall Street Journal’s Future of Everything Festival.

The FDA/CDC decision is expected next month.

In other virus news, STAT News interviewed a top CDC expert on monkeypox. From the FEHBlog’s standpoint, the key takeaway is that monkeypox is not Covid.

I think we can take away a lot from what we know about monkeypox in Congo Basin and in West Africa. Even if human-to-human transmission is documented, it is generally documented among very close contacts. So family members, people taking care of ill patients. Or health care providers.

In funding news, the Department of Health and Human Services announced today a $1.5 billion funding opportunity under the State Opioid Response

SOR grant program provides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.

From the miscellany department

  • Today “the U.S. Office of Personnel Management (OPM) released guidance regarding the implementation of EO 13932; Modernizing and Reforming the Assessment and Hiring of Federal Job Candidates.  OPM’s guidance represents a major step towards the federal government’s adoption of skills-based hiring practices and is an important innovation in federal hiring, which has historically relied on education and candidate self-assessments as a proxy for a candidate’s ability to perform in a job. This new approach helps hiring managers recognize and value skills regardless of where they were acquired, whether in a formal degree program, on the job, or on one’s own.”
  • Employee Benefit News identifies the ten most popular mental health and wellness apps.
  • Benefits consultant Tammy Flanagan discusses federal employee life insurance benefits in Govexec.
  • Health Payer Intelligence reports that CMS has updated the Medicare.gov website “to include new features such as highlighting pages that answer popular questions and spotlighting key steps that consumers should take related to Medicare coverage.”

Weekend update

David Ermer–ACA, Congress, COVID-19, Rx coverage, U.S. Healthcare–

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.