Midweek Update

COVID treatment

Midweek Update

David Ermer–AHRQ, COVID treatment, COVID-19, HSA, Mental health care, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Wall Street Journal reports

Kevin McCarthy and his allies launched a new round of talks late Wednesday with a small but stubborn band of conservative holdouts who have blocked his bid for House speaker, as Republicans sought a path forward following a second day of votes without a winner.

Mr. McCarthy didn’t reach the majority in of three votes on Wednesday, deepening doubts about whether he would ever be able to bring enough Republicans to his side and fueling talk of alternatives.

Twenty GOP lawmakers remained opposed, along with all Democrats, blocking the California Republican from getting the necessary majority of the full House. After the sixth vote, the House adjourned and reconvened at 8 p.m. [at which point the House voted 216 to 214 to call it a day and convene at noon on Thursday.]

A flurry of meetings were taking place by early evening with Republicans shuttling between offices. In one major concession, a McCarthy-aligned super PAC, the Congressional Leadership Fund, agreed to stop picking candidates in primaries where the seat is expected to stay in Republican hands.

From the Omicron and siblings front, we have a man bites dog story.

First Nature informs us that “COVID drug Paxlovid was hailed as a game-changer. What happened?
Insufficient investment and fears about rebound and side effects are driving dowthe n use of a lifesaving antiviral.” The FEHBlog, who has had four Covid vaccinations, points his finger at the government for promoting vaccinations, which, while helpful for older and immunocompromised folks don’t prevent the illness yet, over Paxlovid, a treatment for virtually everyone.

Here’s the twist. CNBC reports

A new antiviral pill for Covid was found to be as effective as Paxlovid at curbing mild to moderate illness among people at high risk of severe disease in a Phase 3 trial in China.

The results, published Wednesday in The New England Journal of Medicine, suggest that the treatment had fewer side effects than Paxlovid, the go-to antiviral for high-risk patients. Around 67% of people who took the experimental pill, called VV116, reported side effects, compared to to 77% who took Paxlovid.

The new pill was also less likely than Paxlovid to cause unexpected side effects due to reactions with other medications, such as those for insomnia, seizures or high blood pressure.

“You have a medication that looks to be just as good as Paxlovid, but less cumbersome,” said Dr. Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

VV116 is similar to the antiviral remdesivir, which the Food and Drug Administration has approved as an IV infusion. But the team behind the new drug — pharma companies Junshi Biosciences and Vigonvita Life Science — tweaked the formula so that the body can absorb it in pill form, said Dr. Peter Gulick, an associate professor of medicine at Michigan State University. Gilead Sciences, which developed remdesivir, is testing a similar oral version of its drug.

From the Rx coverage front —

  • STAT News reports “Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday.” P.S. FEHB plans can only cover abortion drugs when abortion is necessary to save the life of the pregnant woman, or if the pregnancy arises from incest or rape.
  • The Drug Channels blog tells us

For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.

The factors behind declining drug prices will remain in the coming years—and become even stronger due to forthcoming changes in Medicare and Medicaid. Employers, health plans, and PBMs will determine whether patients will share in this ongoing deflation.

Read on for details and make up your own mind. And please pass the news along to the drug pricing flat earthers (#DPFE) who refuse to accept that brand-name drug prices are falling—or that prescription drug spending is a small and stable portion of overall U.S. healthcare expenditures.

  • Health Payer Intelligence tells us

Insulin costs vary based on insurance coverage type and coverage types that lead to high healthcare spending can force patients to ration their insulin supplies, a report from the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) uncovered.

Healthcare spending for individuals who have diabetes—including diabetes treatment, comorbidities, preventive care, and more—amounted to approximately $446 billion total in 2019. Drug costs, including spending on insulin, were responsible for nearly a third of that amount (32 percent).

Insulin users, who tend to be in a more severe stage of the disease, contributed 46 percent of the healthcare spending total among patients with diabetes. Average healthcare spending across the population of insulin users is 4.3 times higher than for non-institutionalized Americans. * * *

Medicare beneficiaries had the highest total out-of-pocket healthcare spending for the drug when compared to privately insured and uninsured individuals’ costs. Medicaid out-of-pocket healthcare spending on insulin was low and hard to estimate.

Most insulin users have either Medicare coverage (52 percent) or private insurance (33 percent). The remainder was covered by Medicaid or reported being uninsured.

It’s worth adding that Medicare covers insulin under Medicare Part B, not Part D.

From the U.S healthcare front —

  • The American Hospital Association relates “U.S. hospitals and health systems continued to experience negative operating margins through November 2022, Kaufman Hall reported today. Median operating margins were down 44% so far this year compared with 2021, as high labor and other costs continued to outpace revenues, according to data from over 900 hospitals.”
  • BioPharma Dive reports “Moderna said Wednesday it will pay $85 million to buy OriCiro Genomics, describing the company’s tools as “best in class” for the synthesis of plasmid DNA.”

From the telehealth front

  • The Agency for Healthcare Quality and Research released a report on the use of telehealth during the Covid era.
  • The Society for Human Resource Management reminds us “Employers [sponsoring health plans including FEHB plans] will have the option to provide pre-deductible coverage of telehealth services for people with high-deductible health plans for another two years [through December 31, 2024].

From the No Surprises Act front, Health Dive digs into the recent CMS report on first-year experience with the NSA’s arbitration process.

The report from regulators provides insight on how the arbitration system is faring so far. It helps paint a picture of how frequently the portal is being used and the types of services payers and providers found themselves fighting over. It also shows what providers have initiated the most disputes.

The vast majority of disputes originated from emergency room visits.

About 81% of disputes (excluding air ambulance services) started in the emergency room.

The entities that initiated the most [arbitrations] were mainly physician staffing and revenue cycle management firms, including TeamHealth and Envision Healthcare, private equity backed practices that staff emergency rooms around the country. As a business strategy, the two work out of network, which can lead to surprise billing if the hospital remains in network, according to a prior study from Yale researchers.

The 10 groups that submitted the most disputes accounted for 75% of all the disputes involving out-of-network emergency services and non-emergency items.

From the public health front, “the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which shows how people living in America reported about their experience with mental health conditions, substance use, and pursuit of treatment in 2021. The 2021 NSDUH national report includes selected estimates by race, ethnicity, and age group. It is the most comprehensive report on substance use and mental health indicators that SAMHSA has released to date.” This HHS announcement summarizes the survey’s findings.

From the OPM front, Federal News Network reports on OPM’s plans to refresh its website, which in the FEHBlog’s opinion can’t come soon enough. “Aside from overhauling its main website, OPM is also planning to make more updates to its retirement services. It’s the area of the agency that encompasses the most legacy — or outdated — technology in all of OPM, [an OPM spokesperson] said. Bravo.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, FDA, Rx coverage, Uncategorized–
Photo by Josh Mills on Unsplash

The Washington Examiner reports that “President Joe Biden signed the nearly $2 trillion omnibus spending bill into law Thursday night while vacationing in St. Croix.”

The New York Times relates,

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.

The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documentsshowed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.

STAT News seconds the Times report:

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

STAT News also presents eight key takeaway‘s from the Congressional report on Aduhelm’s approval and reports

Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year. 

Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy. 

“The results from this long-awaited study are great news for hemophilia B patients that soon may have access to a second durable treatment option,” Luk Vandenberghe, a gene therapy expert at Harvard, said in a text message, after reviewing the results. 

Looking toward next year, STAT News discusses “three things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs.”

Consider the already-astronomical cost of chronic disease care in the United States: trillions of dollars devoted to diabetes, heart disease, kidney disease, cancer and other conditions, and still so many people unable to access necessary care and treatments. Consider the strain of Covid on the health care system, the decimation of public health staffing, and the scarcity of health care workers — and how all these costs make their way to patients. What bold moves can be made in 2023 to help reduce the cost of care? We’ll see.

Also, from the healthcare cost front, Beckers Hospital Review looks into “Questions about hospitals’ culture, leadership, survival and opportunity come with a trillion-dollar price tag given the importance of hospitals and health systems in the $4.3 trillion U.S. healthcare industry.” 

From the public health front, the Wall Street Journal reports

A measles outbreak among mostly unvaccinated children in Ohio that local health officials feared could take months to control has slowed in the past week, giving hope that what was expected to be a lengthy battle could be cut short.

The total number of cases since the outbreak began in November reached 82 on Thursday, but new cases have fallen off significantly in the last seven days or so, said Mysheika Roberts, Health Commissioner for the city of Columbus.

“It could be much worse,” Dr. Roberts said Thursday. “I’m hoping due to our outreach in the community, and the community’s willingness to roll up their sleeves and get vaccinated, that we might be starting to see the end of this. But obviously, it’ll take several weeks and days before we’ll know if this is actually over.”

From the Rx coverage front, Medscape tells us

Merck & Co Inc’s COVID antiviral molnupiravir speeds up recovery but does not reduce the hospitalisation or death rate in higher-risk vaccinated adults, detailed data from a large study showed on Thursday. * * *

When Merck originally tested molnupiravir, it was found 30% effective in reducing hospitalisations, but that was in unvaccinated patients.

In the latest study, led by University of Oxford researchers, nearly all of the more than 25,000 patients in the study had received at least three vaccine doses.

These results demonstrate that vaccine protection is so strong that there is no obvious benefit from the drug in terms of further reducing hospitalisation and deaths, said study co-author Jonathan Van-Tam from the University of Nottingham.

The drug was, however, effective in reducing viral load and can help hasten patient recovery by roughly four days, researchers estimated based on study data. 

In interesting social news,

About 2.6 million couples are saying “I do” this year [2022] — roughly 600,000 more than in prepandemic years, according to The Knot, a company that offers wedding-planning tools, a vendor marketplace and a gift-registry platform. 

The wedding boom is the byproduct of two years of the pandemic, when many ceremonies were postponed or pared down, says Lauren Kay, executive editor of The Knot. And ceremonies this year have a whole new vibe. Now, “people feel empowered to personalize, push the envelope—rules are out the window,” Mrs. Kay says. * * *

This year, “weddings are back, and people are excited to celebrate,” Mrs. Kay says. In 2023, weddings in the U.S. will likely return to prepandemic levels at 2.1 million, according to internal research from The Knot.

  • The Washington Post looks into “Why do people like being tipsy? Here’s how alcohol affects the brain. The buzz produced by alcohol comes from a cocktail of pharmacology and social ingredients, research shows.” The article also discusses how to enjoy alcoholic beverages responsibly.

Finally, the Department of Health and Human Services announced

a Notice of Proposed Rulemaking (NPRM), entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination. * * *

Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register.

The NPRM may be viewed here: https://www.hhs.gov/sites/default/files/conscience-rule-nprm.pdf – PDF

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, FDA, HSA, NIH, OPM, Rx coverage–

From Capitol Hill, the American Hospital Association tells us

The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.

The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.

The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.

The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”

In other 2023 Consolidated Appropriations Act or omnibus news

  • The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
  • Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
  • Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
  • The Wall Street Journal reviews the other omnibus provisions affecting businesses.

From the public health front —

Beckers Hospital Review informs us

While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times. 

COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.

“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”

Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.

Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.

“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS

The American Hospital Association tells us

The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.

“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”

STAT News reports

[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.

HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”

From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as

the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).

QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.

Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.

From the Rx coverage and medical research fronts –

MPR reports

The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ICER released evidence reports on Alzheimer’s Disease treatments (draft) and hemophilia A and B (final) STAT News explains

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.

Regarding hemophilia therapies, ICER observes

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).  

Key recommendations stemming from the roundtable discussion include:

  • The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
  • Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
  • At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

NIH announced

Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD). 

Amazing.

From the miscellany department, the Wall Street Journal and MedPage Today explore the new AI text tool known as ChatGPT. From the Journal article

If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.

We have a bipartisan Omnibus bill

David Ermer–Congress, COVID treatment, COVID-19, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Capitol Hill, the Washington Post reports

The Senate on Tuesday took the first formal step toward advancing a bipartisan, roughly $1.7 trillion deal to fund the U.S. government, as Democrats and Republicans raced to avert a shutdown in the final days of the year.

Lawmakers voted 70-25 to begin debate on the 4,155-page measure, known in congressional parlance as an omnibus, which would fund key elements of President Biden’s economic agenda, boost defense programs, and provision an additional $44.9 billion in emergency military and economic assistance for Ukraine.

The lumbering Senate sought to move with uncharacteristic haste after congressional leaders released the full text of the bill in the early hours of the morning, capping off months of intense legislating.

Becker’s Hospital CFO Review, the American Hospital Association, and Politico Pulse offer healthcare takeaways from the omnibus. Of note, Congress laid the groundwork for a soft landing following the public health emergency by addressing Medicaid, the AMA’s concern about the impending Medicare Part B cut (“narrowing the cut to 2 percentage points in the year ahead with a scheduled cut of 3.25 percentage points in 2024″) and extending Medicare telehealth flexibilities and most other Pandemic tied flexibilities through 2024.

Govexec and Federal News Network provide omnibus insights on federal agency and employment issues. Of note, Congress implicitly gave the green light to a 4.6% raise for federal employees in 2023, broken out into a 4.1% across-the-board increase and the remainder allocated to locality pay.

Meanwhile, the FEHBlog wishes to point out that the omnibus includes the three now standard FEHB appropriations measures — the Hyde Amendment restrictions on abortion coverage (Division E summary at 63), the prohibition on applying full Cost Accounting Standards coverage to FEHB contracts (Division E summary, p. 93) and the contraceptive coverage mandate (Division E summary at 68).

What’s more, the OPM appropriations measures include the following

Exploring Tools for Prescription Drug Price Transparency in the Federal Employee Health Benefits (FEHB) Program.- OPM is directed to explore and evaluate the benefits and potential overall cost savings resulting from FEHB Carriers’ implementation of Internet-based self-service tools that deliver transparency and clinical decision support on prescription drug costs to its members. OPM is directed to report to the Committees one year after enactment of this Act, contingent on the availability of funding for this study.

In No Surprises Act news, the Internal Revenue Service issued guidance on calculating the qualifying payment amounts in 2023.

For qualifying payment amounts calculated by increasing the median contracted rate for 201913, the qualifying payment amounts for items and services furnished in 2023 are determined by taking the qualifying payment amounts calculated for items and services furnished in 2022 and multiplying the 2022 adjusted qualifying payment amounts by the percentage increase from 2022 to 2023, that is, 1.0768582128.

For example: An item is furnished in 2023. The median contracted rate for the item on January 31, 2019 was $1,500. The 2022 adjusted qualifying payment amount for the item was $1,597 ($1,500 x 1.0648523983). The 2023 adjusted qualifying payment amount for the item is $1,720 ($1,597 x 1.0768582128).

The notice also provides QPA adjustment guidance for plans that began after January 31, 2019.

From the Omicron and siblings front, the Institute for Clinical and Economic Review (ICER) released “an update to the health benefit price benchmark for nirmatrelvir/ritonavir (Paxlovid™, Pfizer) for the treatment of COVID-19.” 

Based on the current evidence, ICER’s health-benefit price benchmark (HBPB) for Paxlovid is $563-$906 per treatment course. 

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

Of course, at this time, the federal government is covering the cost of Paxlovid for Americans. That may change in 2023 because, contrary to the FEHBlog’s expectation, the omnibus does not appear to include additional funding for Covid vaccines and treatment. However, the FEHBlog is confident that the federal government will find the money if it wants.

From the U.S. healthcare business front, Healthcare Dive tells us

  • Looking to further boost its growing cell therapy business, Gilead Sciences on Wednesday said it plans to acquire Tmunity Therapeutics, a private biotechnology company trying to develop newer, better CAR-T treatments.
  • CAR-T uses genetically engineered T cells to help the body fight diseases like cancer. Gilead currently markets two such products, Yescarta and Tecartus, which it obtained through the $12 billion purchase of Kite Pharma in 2017. Combined, sales of Yescarta and Tecartus were just under $400 million in the third quarter, a nearly 80% increase from the same three-month period a year prior.
  • Gilead said that buying Tmunity should complement Kite’s cell therapy research capabilities by providing a new technology platform, a slate of preclinical- and clinical-stage programs, and a strategic partnership with the University of Pennsylvania. Financial terms of the acquisition weren’t disclosed. The companies expect their deal to close early next year.

In good news, Health Payer Intelligence informs us

The majority of Americans are satisfied with their employer-sponsored health insurance and cited it as the most important benefit an employer can offer, according to a poll conducted by Seven Letter Insight for the Protecting Americans’ Coverage Together (PACT) campaign.

The poll surveyed 2,334 individuals with employer-sponsored health plans between November 14 and November 19, 2022. * * *

Overall satisfaction with employer-sponsored coverage was also high. Most respondents (93 percent) said they were satisfied with their insurance, with 54 percent saying they were highly satisfied. Eighty-seven percent agreed that their plans were affordable, and 73 percent thought their insurance was worth what they paid.

When respondents were asked to describe their employer-sponsored coverage, affordable, high-quality, and comprehensive were the top descriptions, the survey noted.

From the miscellany department —

  • Medscape provides an in-depth look at the progress in the fight against aging.
  • Beckers Hospital Review identifies the top five patient safety issues for 2023.
  • Govexec reports on the progress the federal government’s Merit Systems Performance Board has made since Congress restored the Board’s quorum last May after five years without one.

Weekend update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Mental health care, Telehealth–

The House of Representatives and the Senate will be in session this week for limited Committee business and floor voting.

The Wall Street Journal explains

Lawmakers will return to the Capitol this week with a singular focus of passing a sweeping bipartisan spending bill to avert a shutdown and fund the government through September, despite opposition from many House Republicans.

The massive bill is expected to total around $1.7 trillion and could be released as early as Monday. It would fund government agencies and programs and allow those agencies to distribute grants and contracts to the private sector. 

Because it is the last piece of legislation that Congress will pass in this session, lawmakers have spent weeks lobbying to attach other bills, including funding for Ukraine, changes to tax policy and a measure to update how Congress deals with disputes over certifying presidential-election results. * * *

The Senate is expected to vote on the bill first. Senate Minority Leader Mitch McConnell (R., Ky.) has been part of the negotiations and set a deadline of Thursday to reach a deal—a day before the money runs out—but he said his patience was limited and that he wouldn’t allow talks to stretch past Christmas. 

From the Omicron and siblings front, NPR Shots provides insights on Paxlovid.

The Centers for Disease Control and Prevention recommends treatment for patients at risk of severe disease, hospitalization and death, which includes anyone who’s 50 and older (risk increases with age), people who are unvaccinated and people with certain medical conditions, such as obesity, chronic lung disease, heart disease or a weakened immune system.

But exceptions can be made. A colleague who is under 50 told her doctor she was feeling worse each day after her positive COVID test and had a history of pneumonia. The doctor wrote a Paxlovid prescription. * * *

[In addition to you doctor or pharmacist, t]he federal government has a “Test to Treat” locator to see where you can be tested for free and, if you test positive and are eligible, leave with the drug. Spots include community health centers and some pharmacies. 

Pharmacies may also send the pills to your home for prescriptions the doctor calls in. Walgreens just announced free Paxlovid delivery via Door Dash and UberEATS; CVS will send it the same day for a fee. * * *

Since Paxlovid has to be taken within five days of symptoms starting to work, you might contact your doctor’s office to find out what steps to take if you test positive and think you need the drug. * * *

Paxlovid is the best option for reducing the risk of severe disease. The last monoclonal antibody treatment for COVID-19 lost its FDA authorization last month because it is ineffective against currently circulating variants. That leaves Paxlovid; remdesivir, which requires an outpatient infusion over three days at a hospital or treatment center; and molnupiravir [the other pill], which studies put at only 30% effective in treating the virus. In addition, some doctors are treating immunocompromised patients with convalescent plasma.

Bloomberg Prognosis discusses expiration dates on at-home Covid tests.

The Food and Drug Administration has extended the shelf-lives of 14 brands of tests. Consumers can look up their specific brand and even the lot number to see the correct expiration dates. Brands including iHealth, from a subsidiary of Andon Health in China, Abbott Laboratories’ BinaxNow and ACON Labs Inc.’s Flowfex now last up to 12  months, 15 months and 21 months, respectively. The FDA advises against using at-home Covid tests past their expiration date.

Health plans and Medicare continue to provide at-home Covid tests at no cost, and the federal government resumes mailing out free at-home Covid tests tomorrow.

From the telehealth front —

mHealth Intelligence tells us

Implementing a telehealth navigator program helped improve video visit attendance, providing clinics with a positive financial return, according to a new study published in JAMA Network Open.

The COVID-19 pandemic dramatically drove up the use of telehealth. Like many other healthcare provider organizations, Boston-based Beth Israel Deaconess Medical Center implemented and scaled telehealth visits. But they found that technical issues could hamper video visits, prompting some video visits to be converted into audio-only visits via the telephone, according to the study authors.

The medical center implemented a patient navigator pilot program to reduce barriers to video visit attendance. Through the program, a patient navigator contacted patients one day before their video visit appointment to provide technical support. The navigator went through the steps required for the patient to connect to their visit and addressed frequently asked questions.

The Wall Street Journal reports

Remote treatment of mental-health problems surged in the pandemic, as in-person treatment became difficult while pandemic-driven isolation increased anxiety and depression.

Digital mental-health companies plunged in, promising to provide millions with access to high-quality care by video, phone, and messaging.

Many of the businesses, however, put a premium on growth. Investor-backed, they deployed classic Silicon Valley tactics such as spending heavily on advertising and expansion while often using contractors instead of employees to control costs. A strategy designed for mundane businesses such as food delivery, the formula can be badly suited to the sensitive activity of treating mental-health problems.

No bueno. The article is focused on stand-alone telemental health services.

In the spirit of the Season, Bloomberg Prognosis tackles the question of “Eggnog Made With Raw Eggs Safe.”

“Eggnog may be safely made at home by using egg substitutes, whole, liquid or pasteurized eggs,” Darin Detwiler, a food-safety expert at Northeastern University, says. “These products need no further cooking to kill harmful bacteria.”

Pasteurized eggs are gently heated in their shells to a high-enough temperature to kill any bacteria without cooking the egg. They are pretty widely available, though the texture isn’t always exactly the same as an unpasteurized egg.  

If you are making eggnog the old-fashioned way, Detwiler has some advice for that, too.

“Cook the egg mixture to 160℉ and refrigerate it quickly in several small containers,” he says. “Then it will cool quickly.”

Jingle bells, all.

Monday Roundup

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Federal employment benefits, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the Federal Times offers a detailed report on FEHB infertility coverage. The article answered one of the FEHBlog’s outstanding questions:

In October, the White House Office of Personnel Management, which acts the human relations department for the federal workforce, unveiled four new plan options that will provide some form of assisted reproductive technology, or ART, for a total of 18 FEHB plan options in 2023.

Those are offered by carriers Triple S-Salud, UPMC Health Plan, Indiana University Health Plan, Foreign Service Benefit Plan, and Health Net of California Southern.

One new plan option, under CDPHP, will provide a non-FEHB benefit for discounted ART.

From the Omicron and siblings front —

The New York Times tells us “People who took the antiviral drug Paxlovid within a few days after being infected with the coronavirus were less likely to be experiencing long Covid several months later, a large new study found.” The federal government should be promoting Paxlovid and flu treatments at least as much as it promotes vaccines.

Because winter is coming the Centers for Disease Control reminds us about the importance of home ventilation.

Improving ventilation can help you reduce virus particles in your home and keep COVID-19 from spreading. You may or may not know if someone in your home or if a visitor to your home has COVID-19 or other respiratory viruses. Good ventilation, along with other preventive actions, can help prevent you and others from getting and spreading COVID-19 and other respiratory viruses.

Health IT Analytics reports

Researchers from New York University’s Machine Learning for Good Laboratory (ML4G Lab), Carnegie Mellon University, and the New York City Department of Health and Mental Hygiene (NYC DOHMH) have developed an automated machine-learning system designed to detect rare or previously unseen disease clusters.

According to the press release shared with HealthITAnalytics via email, current automated systems used to identify public health threats rely on “syndromic surveillance” to detect existing threats but can fall short of identifying new ones.

“Existing systems are good at detecting outbreaks of diseases that we already know about and are actively looking for, like flu or COVID,” said NYU Professor Daniel B. Neill, PhD, director of the ML4G Lab, in the press release. “But what happens when something new and scary comes along? Pre-syndromic surveillance provides a safety net to identify emerging threats that other systems would fail to detect.”

Bravo.

With the new year less than two months away, Med City New informs us “Consumer research firm Forrester recently predicted major trends that would shape healthcare in 2023. Healthcare stakeholders should prepare for key changes, such as care becoming even more inaccessible for rural patients[, more remote patient monitoring for chronically ill patients] and additional retail entrants into the clinic space.

On a related note, Becker’s Hospital Review identifies the ten states with the most rural hospitals at immediate risk of closure — 1. Mississippi 24; 2. Tennessee 17, and 3. Kansas 16.

In other U.S. healthcare business news

Healthcare Dive reports

  • VillageMD has agreed to acquire medical practice Summit Health for $8.9 billion including debt, the primary care provider announced Monday.
  • VillageMD, which is majority owned by pharmacy chain Walgreens, and Summit Health, the parent company of CityMD, plan to combine their provider locations and VillageMD’s experience with value-based care to help accelerate the transition to risk for payer clients.
  • Cigna’s health services division Evernorth is also taking a stake in the deal, and will become a minority owner in VillageMD at the deal’s close, expected in the first quarter of 2023.

Fierce Healthcare summarizes 3rd quarter earnings reports from major health insurers.

Fierce Healthcare also announced its ten 2022 Women of Influence in Health award winners.

This year’s honorees cover the breadth of the industry, from providers to payers to health tech, and represent some of the industry’s largest companies as well as up-and-coming innovators. Each has been pivotal in helping their organizations—and their patients—navigate some of the most complicated years that we’ve ever faced.

Kudos to the winners.

The Goverment Accountability Office released a report titled “Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets.”

Several companies may be selling health insurance in a given market, but, as we previously reported, most people usually enroll with one of a small number of insurers. Known as market concentration, this can result in higher premiums due to less competition in the market.

We found this pattern continued in 2019 and 2020, with the markets for individuals and for small employers generally becoming more concentrated. Specifically, three or fewer health insurers held at least 80% of the market share for both of these markets in at least 42 states.

From the healthcare quality front, the HHS Agency for Healthcare Quality and Research released

  • a draft Evidence Map of Social and Structural Determinants of Health Risk Factors for Maternal Morbidity and Mortality; the public comment deadline is December 4, 2022.

Also, Fierce Healthcare tells us

The Center for Medicare and Medicaid Innovation (CMMI) released a report Monday updating its strategic vision for implementing value-based care, including detailing its progress since the vision was released last year. One of the key new strategies focused on creating greater care coordination between primary care doctors and specialists, especially surrounding the types of models the center puts out.

From the mental healthcare front, the National Institutes of Health’s NIH in the News for November 2022 features an article on clinical depression for patients.

From the medical device front, the Wall Street Journal reports

A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a closely watched study, but not significantly beyond what medications achieved.

The device cut a crucial measure of blood pressure by only about two points more than the average reduction in study volunteers who didn’t get the procedure, researchers said Monday.

Despite falling short of the study’s main efficacy goal, Medtronic said it has completed its application to the Food and Drug Administration for approval of the device, based on its safety and ability to meet certain secondary goals in the latest study as well as positive data from earlier studies.

If the FDA approves it, the device could offer a new, nonmedication treatment option for people with blood pressure that remains high despite treatment with drugs. It could also be a big-selling product for Medtronic. * * *

Medtronic’s experimental device, Symplicity Spyral, is used to perform a minimally invasive procedure known as renal denervation. 

In renal denervation, doctors insert a spiral-shaped catheter into an artery near the patient’s groin, through which a generator delivers radio-frequency energy to nerves in arteries near the kidneys. These nerves can become overactive and fuel high blood pressure. The device essentially burns these nerves so that they don’t contribute to high blood pressure.

Renal denervation has potential to be a one-time treatment, though researchers are still following patients to see how the benefit lasts.

Weekend update

David Ermer–ACA, Congress, COVID treatment, COVID-19, Rx coverage–
Photo by Dane Deaner on Unsplash

Happy New Year. Shanah Tovah.

The House of Representatives and the Senate are scheduled to be in session this week for Committee business and floor voting. Congress is set to go on an election break on September 30, the end of the federal fiscal year. Due to the incentive to get on the campaign trail, the FEHBlog expects Congress to wrap up by the end of next weekend a continuing resolution funding the federal government through December 16. The Senate version of the continuing resolution will be released tomorrow as negotiations are ongoing.

From the Omicron and siblings front, the Department of Health and Human Services announced how the federal government supports the Covid treatment market as its funding shifts to the private sector.

From the Rx coverage front, STAT News tells us

Brand-name drugmakers increased wholesale prices by 4.9% in the second quarter this year, up slightly from 4.4% a year ago. But when accounting for inflation, wholesale prices fell by 3.7%. Inflationary pressures are likely to push wholesale prices still higher, STAT writes, citing a new analysis. At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.8%, but after considering inflation, net prices actually fell 7.9% compared with 3.8% in this year’s first quarter. This was the largest quarterly decline in real terms seen by analysts at SSR Health, which conducted the analysis.

From the litigation front, Health Affairs Forefront provides helpful background on a September 7 decision from a Texas district federal court holding the Appointments clause of the U.S. Constitution bars the federal government from treating U.S Preventive Services Task Force recommendations as binding on health plans. The lawsuit also involves a Religious Freedom Restoration Act (“RFRA”)claim. The Court has reserved a ruling on appropriate remedies. The FEHBlog expects that the Appointments clause challenge will not survive appellate review but who knows what can happen with an RFRA claim. Another remaining issue is the plaintiffs’ challenge to the contraceptive mandate.

From the maternal care front, MedCity News informs us

Racial disparities in maternal health complications grew amid Covid-19, BCBS report finds
Pregnancy-related complications increased 9% between 2018 and 2020 among all women, but the rate of change is even more significant among women of color. The disparities exist regardless of having commercial insurance or Medicaid. * * *

The fact that racial disparities exist regardless of commercial insurance or Medicaid coverage suggests that the issues are due to broader health challenges, including underlying conditions, racial inequities and biases in the healthcare system, according to the report.

To combat these disparities, BCBS listed several actions players in the healthcare industry can take. This includes adding nurse-midwives and birthing centers to provider networks, expanding coverage for postpartum care to one year after giving birth and using value-based contracts for maternal health.

BCBS doesn’t just call on healthcare leaders to act, but the government as well. In the report, the payer urges Congress to pass the Congressional Black Maternal Health Caucus’ Momnibus package, which provides steps to improve health outcomes for pregnant women and mothers of color. BCBS also asks for states to extend Medicaid coverage from 60 days to a full year postpartum, an option provided through the American Rescue Plan Act.

One’s race or ethnicity should not determine how likely you are to suffer from pregnancy-related complications. We must address deep-rooted issues like implicit bias and systemic racism that cause these disparities in the first place,” [Dr. Adam] Myers said in a news release.

Monday Roundup

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, NIH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omnicron and siblings front —

The Wall Street Journal and STAT News consider when the Covid pandemic will be over in the United States in response to the President’s comment to a 60 Minutes interviewer Sunday night.

STAT News also offers an interview with the President’s science advisor Francis Collins, MD. Dr. Collins “revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.”

The Wall Street Journal adds

More than a year-and-a-half after the first Covid-19 vaccines became available, people are trickling in every day to get their first doses. 

As health officials and physicians roll out retooled boosters targeting substrains of the Omicron variant, federal data suggest there are still thousands of people a day getting shots of the original vaccines for the first time. 

All together, the seven-day average for adults getting first shots each day ranged between roughly 15,000 and 18,000 in late August, according to a Wall Street Journal analysis of data from the U.S. Centers for Disease Control and Prevention. 

The data can overestimate first-shot recipients, because there are times where the agency can’t link follow-up shots, including boosters, to people who received an initial series. The same effect can lead to an undercount of booster shots, according to the CDC.

People who recently got the first jab cited a range of reasons. Some said they were ordered to do so, such as to start a new job or travel for a vacation. Others waited until a vaccine using a more-traditional technology, instead of the newer mRNA versions, became available. Some went ahead after getting sick with Covid-19, or after a family member vouched that the shots worked. 

Perhaps this news will reassure Dr. Collins.

Moreover, Paxlovid helps people who contract Omicron whether or not they are vaccinated. However, STAT News cautions that advances in treating the sickest Covid patients have stalled since February 2021.

From January 2020 to February 2021, researchers proved four different effective therapies for patients hospitalized with Covid-19 — a lightning pace for drug research, where progress is often measured in decades.

That picture has changed starkly. Advances in treating the sickest Covid patients have stalled. Since February 2021, no new therapies for the hospitalized have emerged as decisively effective, even as over 2,000 patients continue to die daily around the globe, including 300 to 500 in the U.S. * * *

[The stall is due to the fact that m]ost trials have been too small to generate decisive results. Breakthroughs in treating hospitalized patients have come exclusively from large coordinated studies run by governments, NGOs, or consortiums, often testing multiple therapies at once. 

As severe Covid grows rarer, those large studies become harder to do. The U.K.’s landmark Recovery trial, which early on demonstrated steroids were effective and hydroxychloroquine was not, is still ongoing and has expanded to new countries. But it hasn’t issued results since May and hasn’t shown a new therapy was effective since 2021. 

Quite a conundrum.

In monkeypox news, Fierce Healthcare tells us

New cases of monkeypox are down 50% since early August, the Center for Disease Control and Prevention announced in a press briefing.

The nation’s seven-day average for new cases peaked on Aug. 10, with 461 cases, and on Sept. 14 was 170, according to federal health officials. Credit for the decrease was given to education and vaccination efforts.

“We approach this news with cautious optimism,” said Rochelle Walensky, M.D., director of the CDC, at a Sept. 15 press briefing. “We continue to closely monitor data on this outbreak, those at risk, and how prevention measures are being used.”

Walensky stated that while overall growth was down, geographical pockets of the U.S. still showed an increase in cases. Over 23,000 cases of the virus have been confirmed in the U.S. as of Sept. 16.

From the maternal health front, the American Hospital Association reports

An estimated 84% of pregnancy-related deaths in 36 states between 2017 and 2019 were preventable, according to a new Centers for Disease Control and Prevention report based on data from interdisciplinary committees that review deaths during and up to one year after pregnancy.

Among deaths with information on timing, 22% occurred during pregnancy, 25% on or within seven days of delivery, and 53% seven days to one year after pregnancy. The leading underlying causes of pregnancy-related death were cardiac and coronary conditions among Black people, mental health conditions among Hispanic and white people, and hemorrhage among Asian people.

The first data released under a CDC-funded program to support these Maternal Mortality Review Committees, the report “paints a much clearer picture of pregnancy-related deaths in this country,” said Wanda Barfield, M.D., director of CDC’s Division of Reproductive Health at the National Center for Chronic Disease Prevention and Health Promotion. “The majority of pregnancy-related deaths were preventable, highlighting the need for quality improvement initiatives in states, hospitals, and communities that ensure all people who are pregnant or postpartum get the right care at the right time.”

From the healthcare costs front, Health Leaders Media discusses a Buck Consultants survey of health insurers and administrators finding rising costs in employer-sponsored plans.

In US healthcare business news –

The Wall Street Journal reports

A federal judge Monday ruled against a Justice Department antitrust challenge to UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc., rejecting government claims that the deal would unlawfully suppress competition and limit innovation in health-insurance markets.

U.S. District Judge Carl Nichols ruled for the companies in an opinion that he kept under seal for now because he said it “may contain competitively sensitive information.” The judge said he would release a redacted public version of the ruling in the coming days. In a one-page public order, he denied the Justice Department’s request to block the companies from completing the deal.

The lawsuit, filed in February, is an early blow to stepped-up antitrust enforcement by the Biden administration. The department didn’t immediately respond to a request for comment.

The decision is a triumph for UnitedHealth, which owns the largest U.S. health insurer and a healthcare operation that comprises thousands of doctors as well as clinics, surgery centers and other assets, along with a powerful conglomeration of health data.

Healthcare Dive adds

Humana expects to pay between $450 million and $550 million to acquire the first group of senior-focused primary care centers that it developed through a joint venture with Welsh, Carson, Anderson & Stowe, Chief Financial Officer Susan Diamond said Friday during the insurer’s investor day.

The agreement inked with Welsh Carson in 2020 included options for Humana to acquire the private equity firm’s interest in the joint venture in stages over the next five to 10 years. The venture was expected to open 67 clinics by early 2023. “We are planning for the full acquisition of centers built in partnership with Welsh Carson through our put and call options beginning in 2025,” Diamond said.

In mid-May, Humana and Welsh Carson announced a second joint venture that will spend up to $1.2 billion to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 under the CenterWell Senior Primary Care brand.

From the Medicare front, STAT News relates

Chronic kidney disease, already a problem affecting millions of Americans, is only expected to become more prevalent as the country ages. For those with end-stage disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine.

As a medical treatment, dialysis is a stopgap measure that fails to fix a chronic problem (average life expectancy on dialysis is five to 10 years). As an industry, dialysis has significant flaws, including a lag in home dialysis use. Critics argue dialysis clinics have for decades shirked a responsibility to help patients get on the kidney transplant waitlist and receive organs from living donors — the gold standard. 

Now federal health officials are trying to fix those problems with a big policy experiment, using one of their biggest hammers: how dialysis providers are paid. 

That should get the dialysis providers’ attention.

From the National Institutes of Health front, the NIH Center for Alzheimer’s and Related Dementias issued an update on its work and operations.

Midweek update

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Omicron and siblings front —

The New York Times reports

The Food and Drug Administration on Wednesday [August 31] authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.

The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.

With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.

The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.

Here’s a link to the CDC’s 2021 U.S. life expectancy report which was released today.

Reuters adds

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday [September 1] to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant.

A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE , as well as Moderna Inc is expected to pave the way for a rollout next week.

Medpage Today offers background on tomorrow’s CDC Advisory Committee on Immunization Practices meeting.

ACIP will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.

While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.

That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.

David Leonhardt, writing in his Morning column for the New York Times, provides his latest Covid poll which finds all Americans trending toward placing Covid in the rear view mirror.

A growing number of very liberal Americans have decided that it’s time to treat Covid as an unpleasant but manageable part of life, much as many other Americans — as well as people in other countries — decided months ago.

While the FEHBlog was pleased with the Times poll results, he thinks that Forbes hits the nail on the head with its opinion piece on how America can bring down its Covid death rate which took 383 lives yesterday.

Tragically, the vast majority of Covid-19 deaths are now preventable – if all Americans were up to date with vaccines, and if high-risk individuals got treated promptly after testing positive. If all that were to happen, Covid deaths in the U.S. would be nearly zero, as White House Covid-19 Response Team Coordinator Dr. Ashish Jha told the U.S. Chamber of Commerce Foundation recently.

What can the nation do to make that happen? Put simply, we must embrace the notion that Covid-19 deaths are largely preventable, not inevitable. Instead of trying to put those deaths out of mind, we should focus on what we can do to stop them.

Why are 400 Americans still dying each day? For starters, 15 million seniors have not received their first booster, and only 33% of Americans over 50 and 40% over 65 have received their second booster. In addition, over 20% of adults have not completed their primary vaccination series.

The health impacts of that inaction are sizable. The CDC estimates that among those 50 and older, the unvaccinated had a 29-fold increased risk of dying from Covid-19 and vaccinated people with only one booster had a 4-fold increased risk compared to those with two or more booster doses.

Meanwhile, access to the oral antiviral medication Paxlovid – which reduces the rates at which high-risk people get severe cases of Covid-19 or die from it – is the most limited in zip codes in which people were highly vulnerable to the virus. Moreover, access to and awareness of Evushield – which reduces the risk that immunocompromised people will develop symptomatic Covid-19 for up to six months – remains limited.

To keep Covid-19 and its impact in public consciousness, local health officials should publicly recognize when citizens in their communities lose their lives to the virus. For the same reason, local print and broadcast media should provide coverage of community memorials to those who have died. That should inspire citizens within communities to help each other fully access and use the tools available to all Americans, whether vaccines or treatments.

Local faith organizations, businesses, and other community leaders who have the trust of the population should redouble their efforts reminding individuals that their actions with respect to Covid-19 testing, vaccination, and treatment can make a tangible difference for their community.

Health care professionals should use every office visit, even if unrelated to Covid-19, to remind patients about the need to stay up to date with their vaccinations and have a plan to access treatment if they test positive and are eligible for treatment. The medical community’s attention to preventing and managing chronic conditions such as obesity and diabetes is now even more vital given their detrimental impact on Covid-19 outcomes.

Amen to that. Honestly, while the FEHBlog falls into the senior category, he has been delaying his second booster in order to receive the bivalent vaccine (or the Novovax booster which hasn’t been approved yet). The FEHBlog plans to make an appointment for the bivalent vaccine next week.

Finally, Healthcare Dive informs us

Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to Dawn O’Connell, Assistant Secretary for Preparedness and Response at the HHS.

The announcement comes after the HHS hosted over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies in a planning meeting on Tuesday.

“While the federal government has been pleased to play this role, we have always known that we would not be in this business forever,” O’Connell said in a post on the ASPR site. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.”

Read that as health plans may have to pay for their members’ Covid vaccinations next year. Conceding that the FEHBlog is not a Hyde amendment expert, he does not understand why the Senate leadership did not ram through more Covid funding in the massive budget reconciliation act.

Moving onto the country’s fentanyl crisis

CBS News tells us

The Drug Enforcement Administration issued an advisory Tuesday about an “emerging trend” of “brightly-colored” fentanyl pills being used to lure children and young people. What is often called “rainbow fentanyl” has been seized by law enforcement agencies in 18 states just this month, the DEA said.

The drugs, made to look like candy, comes in several forms, including “pills, powder and blocks that resembles sidewalk chalk,” the DEA said.

“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement.

Regulatory Focus adds

The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.
 
On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.
 
In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.

In U.S. healthcare business news, Healthcare Dive reports

Walgreens Boots Alliance has completed its majority stake acquisition in at-home care technology platform CareCentrix, the retail pharmacy giant announced Wednesday.

The $330 million investment gives Walgreens a 55% ownership of CareCentrix. Walgreens has the option to acquire the remaining equity in the future.

The investment, first announced in October, expands Walgreen’s reach in the health sector, especially in the areas of primary care, specialty pharmacy, post-acute and home care, the company said in a Wednesday release.

STAT News observes

Employers, who provide health coverage to roughly half the U.S. population, are acutely aware of where health care’s current cost trajectory is headed. In a recent survey of executives at 300 of the country’s largest employers, nearly 90% said they believe the cost of providing health benefits will become unsustainable within five to 10 years.

Yet instead of finding new ways to manage costs and help sustain this critical lifeline for America’s workers, many health systems continue to increase the prices they charge commercial insurers. And they can because, in many cases, newly consolidated health systems are the only game in town.

Employers and private insurers pay, on average, 224% of what Medicare would have paid for the same service at the same facility, despite new data showing that hospitals require payments that represent just 127% of Medicare to cover their expenses.

In federal employee compensation news, Federal News Network reports

President Joe Biden has formally announced his plans to give civilian federal employees a pay raise next year, starting on Jan. 1, 2023.

Most civilian employees under the General Schedule, as anticipated, will receive an average 4.6% federal pay raise in 2023, according to the alternative pay plan Biden submitted to congressional leaders Wednesday afternoon.

The president is specifically recommending a 4.1% across-the-board pay raise for federal employees in 2023, with an additional 0.5% average locality pay adjustment — resulting in a 4.6% average pay increase.

Biden said his alternative pay plan would help federal pay stay competitive with what workers with critical skills could earn in the private sector.

Thursday Miscellany

David Ermer–COVID treatment, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the omicron and siblings front, MedPage Today provides us with good news.

Older patients treated with nirmatrelvir boosted by ritonavir (Paxlovid) for COVID-19 had lower rates of hospitalization and death compared with those not treated with the antiviral during the Omicron wave, according to an observational retrospective cohort study from Israel.

Among patients ages 65 and older, the rate of hospitalization due to COVID was 14.7 cases per 100,000 person-days for the 2,484 patients who received nirmatrelvir compared with 58.9 cases per 100,000 person-days for the 40,337 untreated patients (adjusted HR 0.27, 95% CI 0.15-0.49), reported Ronen Arbel, PhD, of Clalit Health Services in Tel Aviv, and colleagues.

Death occurred in two nirmatrelvir-treated patients and in 158 untreated patients (aHR 0.21, 95% CI 0.05-0.82), they said in the New England Journal of Medicine.

Herd safety, indeed.

From the Rx research and development front, NBC News reports

Two doses of psilocybin pills, along with psychotherapy, helped people with alcohol use disorder reduce drinking for at least eight months after their first treatments, results from the largest clinical trial of its kind show. 

During the eight-month trial, 93 men and women ages 25 to 65 were chosen to receive either two psilocybin doses or antihistamine pills, which the researchers used as a placebo. They all also participated in 12 psychotherapy sessions.

All of the volunteers were averaging seven alcoholic drinks at a time before the trial. 

More than 80% of those who were given the psychedelic treatment had drastically reduced their drinking eight months after the study started, compared to just over 50% in the antihistamine control group, according to results published Wednesday in JAMA Psychiatry. At the end of the trial, half of those who received psilocybin had quit drinking altogether, compared to about one-quarter of those who were given the antihistamine.

STAT News reports

A vaccine Pfizer is developing protected older adults against the respiratory syncytial virus, or RSV, which is a common cause of hospitalization and death in the U.S., the company said Thursday.

The experimental vaccine, known as RSVpreF, is considered a key product in Pfizer’s pipeline of experimental drugs. Right now drug companies are close to launching several different products against RSV, focused on protecting both older adults and infants.

BioPharma Dive tells us

BioMarin, a California-based biotechnology company, said Wednesday that its gene therapy for hemophilia has been cleared for market by European regulators, marking a first-of-its-kind approval.

The therapy, known as Roctavian, was given conditional marketing authorization as a treatment for certain patients with hemophilia A, the more common version of the rare bleeding disorder. Specifically, Roctavian is to be used in adults with “severe” disease — hallmarked by exceedingly low levels of a blood-clotting protein called Factor VIII — who don’t have a history of developing antibodies that attack this protein.

With approval in hand, BioMarin is now working to secure reimbursement across the European Commission’s various member states. Jeff Ajer, the company’s chief commercial officer, said on a conference call Thursday that the plan is to immediately launch Roctavian in Germany, followed by France. The company expects Roctavian’s list price in Europe to be “around” 1.5 million euros, or roughly $1.5 million, net of all discounts, he said. 

Ajer added that BioMarin expects to disclose the specific European list price in October, a number that will be in-line but lower than the comparable net price in the U.S.

From the mental healthcare front —

Fierce Healthcare tells us

Employers view long-term mental health as the key healthcare issue coming out of COVID-19, according to a new survey.

Nearly half (44%) of employers surveyed by the Business Group on Health said they have seen this trend in their workforces, and another 44% expect to see worsening mental health in the future. Most (85%) said they anticipate enhanced mental health benefits launched under the pandemic to continue.

Mental health conditions also ranked sixth on the survey’s list of conditions driving healthcare costs, with 17% of those surveyed saying it was a major driver. This is a marked increase from 9% in 2020 and 14% in 2021.

Brenna Shebel, vice president of the Business Group on Health, said during a briefing with reports Tuesday that many employers are tackling mental health challenges “at all different angles.”

Forbes adds

AHIP, which stands for America’s Health Insurance Plans, issued a statement and “advocacy vision” at a time its member health plans are looking beyond paying and coordinating just medical care but also integrating behavioral health care into benefit plans for their government, commercial and employer clients. * * * Further details of the policy proposals and commitments can be found here.

From the U.S. healthcare business front, we learn about financial results for two health systems involved with the FEHB Program.

Becker’s Hospital Review reports that ” Intermountain Healthcare [based in Utah and serves surrounding states] saw its revenues increase in the first half of this year, and its merger with SCL Health fueled a significant increase in net income, according to recently released financial documents. The financial documents are the first Intermountain has filed since completing a merger with Broomfield, Colo.-based SCL Health in April. 

Beckers Hospital CFO Report tells us, “UPMC reported higher revenue in the first half of this year than in the same period of 2021, but the Pittsburgh-based health system’s operating income declined year over year, according to financial documents released Aug. 23. * * * “Throughout 2022, the continued effect of COVID-19, along with conditions in the labor and supply markets have resulted in cost growth in employment, staffing and other operating expenses in excess of revenue growth,” UPMC management wrote in the financial filing.”

Finally STAT News delves into why so many large healthcare companies are interested in Signify Health. Quite simply,

The bidding war over Signify Health — a health technology business that could fetch multibillion-dollar offers from Amazon, CVS, and UnitedHealth Group — is not about its dazzling software or a blockbuster AI algorithm.

The crush of corporate interest, experts said, stems from something much bigger: the opportunity to move medical services back into the home. In-home care is quickly becoming the biggest battlefield in America’s biggest business, with a huge array of companies seeking to move health care outside the institutional walls that have confined it for much of the last century.

Signify Health is among those at the forefront of the quest. The Texas-based company, founded in 2017 as the result of a merger, has built its business around delivering highly detailed assessments of patients by visiting with them in their bedrooms and living rooms, creating better visibility — and clearer data — about their lives and health status.