Tuesday’s Tidbits

COVID-19

Tuesday’s Tidbits

David Ermer–COVID-19 vaccine–
Photo by Patrick Fore on Unsplash

From our Nation’s capital, the Wall Street Journal reports

President Biden said Tuesday he would nominate Julie Su, the No. 2 official at the Labor Department, to lead the agency, maintaining continuity within a department that played a prominent role in averting a rail strike last year.

Ms. Su, the current deputy secretary, was widely seen as the leading candidate to succeed departing Secretary Marty Walsh. Asian-American lawmakers and advocacy groups threw their support behind her, lobbying Mr. Biden to tap his first Asian-American cabinet secretary. Ms. Su, age 54, is Chinese-American.

The nomination now heads over to the Senate for its approval. The Secretary of Labor, the HHS Secretary, and the Treasury Secretary / IRS form the agencies responsible for the overseeing the Affordable Care Act.

From the Food and Drug Administration (FDA) front —

Endpoint News informs us

Pfizer and BioNTech are seeking full [FDA marketing] approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.

The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.

The move is in response to an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) vote last month, intended to clear up confusion around varying primary and booster dose formulations and utilize vaccines that better target currently circulating strains of Covid.

MedPage Today relates

In two somewhat close votes, an FDA panel of outside experts recommended the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, despite concerns over the potential risk for Guillain Barré syndrome.

By a tally of 7-4 for safety and efficacy (with one abstention in each case), the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the evidence favors the RSV prefusion F protein vaccine (RSVPreF) — which carries a proposed trade name of Abrysvo — for reducing RSV-related lower respiratory tract infections in adults 60 and up.

However, VRBPAC members showed reservations ranging from the largely health study population, rather than the more vulnerable group of older adults who need the vaccine most, to the limited number of events for the main outcomes.

The Wall Street Journal reports

Federal regulators approved a drug to treat a debilitating disease using data collected about patients over decades, creating an opening for researchers of other rare conditions who often struggle to prove their treatments work.

The Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s drug Skyclarys, or omaveloxolone, for treating the neurological disorder Friedreich’s ataxia in adults and adolescents age 16 and older.

The FDA last year said results from a single clinical trial didn’t sufficiently demonstrate the drug slows the progression of a disease that causes progressive damage to the spinal cord, muscle weakness, and movement problems and often kills people by age 35. Instead of running another trial, Reata submitted additional data including an analysis from a so-called natural history study that has continued to collect information about patients for more than two decades.

“Data created by patient communities can be regulatory grade,” said Annie Kennedy, chief of policy, advocacy and patient engagement at the EveryLife Foundation for Rare Diseases, a nonprofit advocacy group. “This approval is proof of that principle.”

MedPage Today adds

The FDA issued an import alert Tuesday to clamp down on the illegal importation of xylazine, an animal tranquilizer showing up more and more in illicit drugs.

“This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals,” the agency said in a press release.

Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects, the FDA noted. However, “it has been identified as a contaminant found in combination with opioids such as illicit fentanyl, and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.”

From the U.S. healthcare front —

The American Health Association points out

Hospitals continue to experience the same challenges that made 2022 the worst financial year since the start of the COVID-19 pandemic, including higher labor expenses and lower patient volumes, according to the latest report on hospital finances from Kaufman Hall. Hospital operating margins fell from -0.7% in December 2022 to -1% in January 2023, following persistent negative margins throughout last year. Notably, drug expenses have increased 12% compared to YTD 2020. 

“While we have seen a stabilization in operating margins over the past several months, the trendline continues to show that hospitals will be in a tough spot financially for the foreseeable future,” said Erik Swanson, senior vice president of data and analytics for Kaufman Hall. “With future COVID surges possible and challenging financial months ahead for hospitals, managing cash on hand will be critical to weathering the storm.”

The Wall Street Journal explains how doctors are diagnosing patients with artificial intelligence.

From the mental health care front —

  • The Kaiser Family Foundation provides good news about the rapidly growing use of the 988 National Suicide Prevention and Crisis Hotline. “Since the launch of 988, Lifeline has received over 2.1 million contacts—consisting of over 1.43 million calls, over 416,000 chats, and more than 281,000 texts.” But, of course, the KKF study also notes some problems.
  • MedCity News tells us about a newly formed collaboration consisting of Bicycle Health, Wellpath and the Federal Bureau of Prisons that will provide virtual opioid use disorder services to those living in the Bureau’s residential reentry centers in 42 states.
  • STAT New discusses the downfall of Mindstrong, a mental health care tech / app company.
  • The Washington Post offers an intriguing look at how the human brain ages.

Monday Roundup

David Ermer–CMS, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the end of the public health emergency front –

CMS issued a comprehensive fact sheet titled “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Notwithstanding the title, the fact sheet includes sections on how the end of the PHE impacts

Private Health Insurance

Vaccines: Most forms of private health insurance must continue to cover COVID-19 vaccines furnished by an in-network health care provider without cost sharing. People with private health insurance may need to pay part of the cost if an out-of-network provider vaccinates them.

Testing: After the expected end of the PHE on May 11, 2023, mandatory coverage for over-the- counter and laboratory-based COVID-19 PCR and antigen tests will end, though coverage will vary depending on the health plan. If private insurance chooses to cover these items or services, there may be cost sharing, prior authorization, or other forms of medical management may be required.

Treatments: The transition forward from the PHE will not change how treatments are covered, and in cases where cost sharing and deductibles apply now, they will continue to apply.

Private Health Insurance and Telehealth

As is currently the case during the PHE, coverage for telehealth and other remote care services will vary by private insurance plan after the end of the PHE. When covered, private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.

For additional information on your insurer’s approach to telehealth, contact your insurer’s customer service number located on the back of your insurance card.

Fierce Healthcare reports

Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the  Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.

Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.

The DEA created a 30 day public comment period for this proposed rule.

From the U.S. healthcare business front, STAT News tells us about this surprising twist

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles. * * *

The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.

The FEHBlog’s guess is that drug manufacturers will be lined up at the bankruptcy courthouse door to place a bid on the company if allowed.

BioPharma Dive informs us

  • “Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said.
  • “Last summer, the Journal reported Seagen, a Washington-based company currently worth more than $30 billion, was considering selling to Merck & Co. for upwards of $40 billion. But as Bloomberg would later report, the deal stalled out because of disagreements over price. Since then, Seagen has brought on a new CEO, the longtime Novartis executive David Epstein, who played an integral role in ramping up the Swiss pharmaceutical giant’s cancer drug division.
  • “Should Pfizer acquire Seagen, it would gain access to a slate of experimental medicines as well as four marketed products that, together, generated $2 billion in revenue last year. Pfizer recorded $100 billion in product revenue in 2022, but estimates sales from its COVID-19 vaccine and Paxlovid therapy will fall significantly in the coming months. It also expects to lose around $17 billion in annual revenue between 2025 and 2030 due to the expiration of key patents.”

From the Rx coverage front —

  • The Wall Street Journal fills us in on the side effects of the new semaglutide weight loss drugs. For example, “Semaglutide spurs weight loss by stimulating the release of insulin and lowering blood sugar. It also delays stomach emptying, which causes people to feel full quickly and stay sated for longer stretches. When a patient comes off the drug, their normal appetite returns. * * * “People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism.”
  • The Journal also reports that “Amyloid Gains Converts in Debate Over Alzheimer’s Treatments; Dispute has far-reaching consequences, including whether Medicare will pay for new anti-amyloid drugs [e.g., Aduhelm and Leqembi].” Nevertheless, “Dr. [David] Knopman [,a Mayo Clinic neurologist,] said that Leqembi’s success is only a partial vindication of the amyloid hypothesis, which in the minds of many doctors promised to stop Alzheimer’s in its tracks or even reverse certain symptoms.” 

From the mental health care front, David Leonhardt, the New York Times Morning columnist, “examines the raging debate about smartphones and teenage mental health.”

I called Lisa Damour last week and asked what advice she would give to parents. Damour is a psychologist who has written two best-selling books about girls and just published a new book, “The Emotional Lives of Teenagers.” She is no anti-technology zealot. She thinks social media can have benefits for teenagers, including connections with peers. But she also sees reason for concern.

Her first piece of advice is not to blame teenagers. They didn’t invent smartphones, and earlier generations would have used those phones in the same ways that today’s teens are.

Her second piece of advice might be summarized as: less. She believes teenagers should rarely have their phones in their bedrooms, especially not at night. A phone is too disruptive to sleep, and sleep is too important to mental health.

Parents can also introduce digital technology in stages, recognizing that a 13-year-old brain is different from a 17-year-old brain. For younger teens, Damour suggests a phone that can send and receive texts but does not have social media apps.

From the miscellany department –

  • Beckers Hospital Review provides details on the business model of One Medical, which became part of Amazon last week.
    • The company employs primary care providers across more than 125 clinics in 19 markets, according to its website. One Medical then partners with local hosptials and health systems to provide specialty care.
    • One Medical offers a subscription-based membership — for $199 a year (though Amazon is now offering a promotion for $144 annually) — that gives patients access to its digital health platform, with 24-7 access to virtual care and online appointment booking and prescription renewals. The company still bills those patients’ insurance for the visits.
  • Govexec reports “The federal employees appeals board is setting new precedents restricting when agencies can fire employees who were injured on the job, issuing new rulings on cases that languished for years while the agency was rendered partially incapacitated.”
  • The Wall Street Journal tells us “The White House said there is no consensus within the Biden administration over the origins of the Covid-19 virus, a day after the disclosure of an Energy Department assessment that the pandemic likely originated with a leak from a Chinese lab.” 

Weekend update

David Ermer–Congress, COVID-19, Electronic health records, FDA, SDOH–
Photo by JOSHUA COLEMAN on Unsplash

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

As we close out Black History Month, let’s join the Trust for American Health in celebrating notable African American in public health.

From the Covid front, the Wall Street Journal reports

The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.

The shift by the Energy Department, which previously was undecided on how the virus emerged, is noted in an update to a 2021 document by Director of National Intelligence Avril Haines’s office.

The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.

From the miscellany department —

  • Fortune Well provides us with insights on how to manage a life-threatening diagnosis.
  • Health Payer Intelligence tells us what payers can expect to find in the proposed CMS electronic prior authorization rule. The public comment deadline on the rule is March 13, 2023

Friday Factoids

David Ermer–CDC, COVID-19, Electronic health records, FDA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.

From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.

The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.

Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
 
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
 
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
 

There you go.

From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].

Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.

The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”

Meanwhile, the Food and Drug Administration announced issuing

an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. 

In other public health news

  • Healio informs us
    • People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
    • “We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
  • The Washington Post reports
    • One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
    • Inflammation in the body may be triggering or exacerbating depression in the brains of some patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
    • The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments. While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
  • The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.

From the wearables front —

  • mHealth Intelligence relates
    • In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
    • Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
    • The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
    • Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
    • Of those who said they used health apps and wearables, most use them daily.
  • Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”

From the miscellany department

  • Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”

Midweek Update

David Ermer–CMS, COVID treatment, FDA, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Affordable Care Act front, the WTW consulting firm informs us

Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.

Also following up on recent posts, Healthcare Dive tells us that

Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.

and

UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.

In other U.S. healthcare business news, Forbes points out that

Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program. 

In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.

In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.

From the medical research front, MedPage Today reports

Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.

Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *

Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.

Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.

and

An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.

The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.

The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.

.From the Rx coverage front —

  • Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”

while

  • The Wall Street Journal reports
    • Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
    • Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
    • The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said.  * * *
    • Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high. 
  • Biopharma Dive tells us
    • By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
    • [A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
    • When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
  • Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.

From the miscellany department –

  • The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
  • Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
  • Health Payer Intelligence reports
    • While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
    • The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
    • Between 2019 and 2023, Medicare Advantage enrollment has grown by 2.1 percent. As of January 2023, 46 percent of all Medicare beneficiaries are enrolled in Medicare Advantage, translating to 29.5 million people. * * *

Happy Presidents’ Day

David Ermer–Congress, COVID treatment, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Mount Rushmore

The House of Representatives and the Senate are on District/State work breaks this week.

Govexec alerts us, “Labor Secretary Marty Walsh will be leaving the Biden administration in mid-March to become executive director of the National Hockey League Players’ Association.” 

Federal News Network offers an update on implementing the Postal Service Health Benefits Program that takes effect on January 1, 2025. The article expresses concern about a tight timeline for implementation. The article does not consider OPM’s January 2023 decision to allow FEHB plans to offer Medicare Part D EGWPs in 2024. That welcome decision puts the new PSHBP and the existing FEHB on a similar footing.

While the new PSHBP will be more tightly integrated with Medicare Part B., the benefits of that phased in change will develop over time. For example, although the Postal Services will offer a one-time, penalty-free Part B Special Open Enrollment Period next year for annuitants over 65 who did not elect Part B, early retirees under 65 and active employees over age 64 on January 1, 2025, will be exempt from the PSHBP’s mandatory Part B election requirement.

In other FEHB news, AHIP has made available a topic overview for the March 29 – 30 OPM AHIP FEHB Carrier Conference.

In OPM news, Meritalk breaks down last week’s inaugural DEIA Annual Report from OPM’s Office of Diversity, Equity, Inclusion, and Accessibility (ODEIA).

From the Omicron and siblings front, the Wall Street Journal and Fierce Healthcare report on the Covid death rate. The Journal points out, “Deaths caused by Covid are heavily concentrated among the elderly, an analysis of CDC data shows. In recent weeks people 75 years and older have represented about seven of every 10 Covid-19 deaths.” Fierce Healthcare provides this perspective:

The JAMA Network Open study concluded that “COVID-19 due to the Omicron variant was associated with a higher risk of in-hospital mortality compared with patients with influenza. This indicates that the SARS-CoV-2 Omicron variant should still be taken seriously, and improved prevention and treatment strategies are still highly relevant, although overburdening of the health care system has become less likely over time.”

Fortune Well tells us about the importance of cardiac care following even a mild case of Covid.

In a bid to determine why and how COVID can affect the heart, Dr. Andrew Marks, a cardiologist and biophysics professor at Columbia University, and Steven Reiken, a research scientist in his lab, studied heart tissue from people who died of COVID, in addition to the hearts of mice that had been infected with COVID.

Among their findings, which they’ll present Monday at the 67th Annual Biophysical Society Meeting in San Diego:

  • Heart tissue from humans shows increased levels of oxidative stress and inflammation, and changes in calcium levels due to damage to the system that regulates them in the heart. Such alterations can lead to arrhythmia or heart failure, according to the researchers.
  • Chest pain and tachycardia, or an unusually fast heartbeat, are common long-term among COVID survivors.
  • Heart tissue from mice shows an increased percentage of fibrosis and dilation of fibers—a common signal of early cardiomyopathy, which makes it more difficult for the heart to pump blood and can result in heart failure.
  • The death of heart cells and blood clots in the hearts of mice who had been infected with COVID-19 were also observed.

“Doctors should be aware of heart changes related to COVID-19 infections and should be looking for them,” Marks says. He hopes his research leads to increased awareness among medical providers of the virus’s potentially stealthy cardiac fallout—and, eventually, treatments for those whose hearts have been damaged by the pathogen.

MedPage Today adds

People who took the antiviral Paxlovid to treat COVID-19 infections were not more likely to get back-to-back bouts of the virus, a new study shows.

The findings offer clarity amid concerns that the use of Paxlovid, which works by stopping the spread of the virus in the body, increased the risk of COVID-19 rebound.

“Rebound is a re-emergence of symptoms and an uptick in viral load after a period of recovery,” the Center for Infectious Disease Research and Policy explained in a summary of the study.

Researchers found that patients who received Paxlovid, another antiviral called Lagevrio, or no antiviral medication had rebounds at similar rates, ranging from 4.5% to 6.6%.

From the medical research front, the Wall Street Journal reports

A fist that opened and shut. A once-limp arm that moved from her side. Two women whose strokes left them with partial paralysis for years saw life trickle back to their limbs when electric pulses were delivered to the back of their spinal cord as part of a pilot study. 

Neurologists said the approach, reported Monday in the journal Nature Medicine, could be transformative for stroke survivors, many of whom have some arm impairment after the event.

“I think it is amazing,” said Helmi Lutsep, a neurologist at Oregon Health & Science University, who wasn’t involved with the study. “I think patients will be thrilled if this comes to fruition.” 

The pilot study was convincing but it would take much larger studies and a decade or more to know if stroke patients generally could benefit, according to Nick Ward, a neurologist at the University College London who wasn’t involved with the study.  

From the U.S. healthcare business front, the Wall Street Journal informs us why “Walgreens CEO Bets on Doctors Over Drugstores in Search for Growth; Rosalind Brewer is shifting the chain’s focus to medical clinics,” like Village MD.

The strategy is guided by Ms. Brewer’s belief that the nation’s second-largest drugstore chain is in a business that she says no longer works. Industry growth is chronically slow, she said. Meanwhile, a shortage of workers is further cutting into revenue because the chain has had to reduce pharmacy hours.  

Friday Factoids

David Ermer–COVID-19, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

    From the Omicron and siblings front —

    The CDC’s Covid Data Tracker shows all news cases, hospitalizations and deaths statistics trending down.

    Health Day informs us, “Natural immunity from a COVID infection confers protection on par with that from mRNA vaccines, but patients run the risk of hospitalization and death during their initial infection.”

    “The vaccines and boosters are still the safest way to acquire immunity, mainly for those who are in high-risk populations,” said study co-author Caroline Stein, a postdoctoral researcher at the University of Washington’s Institute for Health Metrics and Evaluation.

    In fact, the best protection now appears to come from “hybrid immunity,” the combination of an actual infection and vaccination, said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.

    From the public health front —

    • The CDC’s weekly Fluview reports, “Seasonal influenza activity is low nationally.”
    • The Fluview also discusses the risk that avian flu H5N1 poses to humans.
      • “The current public health threat to people from the H5N1 virus is low. The current H5N1 outbreak in poultry and birds continues to be mostly an animal health issue. However, people should avoid direct and close contact with sick or dead wild birds, poultry, and wild animals. People should not consume uncooked or undercooked poultry or poultry products, including raw eggs. Consuming properly cooked poultry, poultry products, and eggs is safe. Other preventive measures are available at Bird Flu: Current Situation Summary “
    • Health Day tells us, based on a recent CDC study, that “Far too many young kids aren’t eating enough fruits and vegetables, even as they consume plenty of sugary sodas.” No bueno.
    • The Wall Street Journal considers “How Common is Depression After a Stroke? Sen. John Fetterman’s Treatment Prompts Question. Depression can often follow a major medical issue or chronic illness. Here’s what to know.”
      • “Overall, between 20% and 30% of people with a chronic illness experience depression, says Karina Davidson, a clinical psychologist and dean of academic affairs at Northwell Health’s Feinstein Institutes for Medical Research.”
    • The Mercer consulting firm explains how new approaches are filling gaps created by obstetric unit closings.
      • “As the access to obstetrics care dwindles, employers can and should be looking for additional solutions to help keep their pregnant members and their newborns healthy. Whether that’s exploring new digital tools [such as Pregnascan and HeraMED] coming to market or just expanding coverage on their health plans to include doulas, community doulas, midwives, and birthing centers, any effort will be an important step forward in the fight to reduce maternal mortality and poor health outcomes in the US.”

    From the No Surprises Act front, a colleague reminded the FEHBlog today that the deadline for health plans and air ambulance providers to submit their first NSA air ambulance report, March 31, 2023, is closing in. While the federal government has made available draft information on preparing this report, no sign of an official submission portal has appeared online. The clock continues clicking.

    From the Miscellany Department —

    • Medscape offers an excellent article on the cost of gene therapies. Remember to click pages.
    • Mercer also delves into the abortion pill coverage quandary. (While FEHB plans must cover contraceptive pills, including the Plan B pill, abortion pills are excluded from coverage unless the mother’s life would be endangered if the fetus were carried to term or when the pregnancy is the result of an act of rape or incest.”
    • The American Hospital Association puts a favorable spin on a recent CMS report on health system compliance with the federal government’s hospital pricing transparency rule.
    • CMS is pleased “to provide you with the recording (password: 4%2M!3c?) and slides of the February 9, 2023, virtual education session hosted by the CMS Office of Burden Reduction and Health Informatics on the Advancing Interoperability and Improving Prior Authorization Processes proposed rule.
      • As a reminder, we welcome your feedback on the proposed policies introduced in the CMS Advancing Interoperability and Improving Prior Authorization Processes proposed rule (CMS-0057-P). Comments must be received within the 90-day comment period, which closes on March 13, 2023. When commenting, please refer to file code: CMS-0057-P.”
    • Beckers Hospital Review reports, “The Federal Trade Commission has welcomed the State University of New York Upstate Medical University and Crouse Health System’s decision to abandon their proposed merger, which it said would have left Syracuse with just two hospital systems — Upstate and St. Joseph’s Health — and given the combined entity a 67 percent share of commercially insured inpatient services in Onondaga County.”

    Thursday Miscellany

    David Ermer–CMS, Congress, COVID-19, Electronic health records, FDA, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From our Nation’s capital

    • Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity.  A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
    • “The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
    • The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
    • The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
    • The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
      • In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”

    From the medical research front

    • STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.” 
    • Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
    • The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
    • The All of Us program shared its research roundup, focusing on heart disease this month.
    • The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
    • The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

    From the U.S. healthcare business front —

    • Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
    • Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.”  A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
    • According to Healthcare Dive
      • CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
      • The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
      • CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
    • Also from Healthcare Dive
      • Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
      • LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
      • Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction. 
      • Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
    • The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA. 
    • Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”

    From the miscellany department —

    • Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
    • CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below.  Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
    • WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”

    Midweek Update

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

    From Washington D.C., Roll Call tells us

    The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.

    The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.

    [A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May. 

    STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up

    What is the AMA stance on implementation of the law to end surprise medical bills for patients?

    There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.

    There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.

    What nonsense!

    Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.

    The National Academies issued a report on “Achieving Whole Health.”

    Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”

    The Office of Personnel Management released

    its inaugural report: Government-wide DEIA: Our Progress and Path Forward to Building a Better Workforce for the American People. This report highlights accomplishments aligned with the Government-wide Strategic Plan to Advance DEIA in the Federal Workforce and preview priorities for 2023 consistent with Executive Order (EO) 14035.

    “Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”

    Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit  Managers.”

    This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.

    From the Omicron and siblings front —

    STAT News reports

    In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.

    The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.

    The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *

    A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.

    No doubt about the validity of AHIP’s point.

    Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”

    From the public health front —

    • The White House announced
      • “the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
    • The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed, as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
    • The National Cancer Institute posts on a variety of cancer topics. For example
      • “The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”

    In other health care cost news —

    Beckers Payer Issues relates

    Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found. 

    Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020. 

    For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron. 

    For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were  54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs. 

    Read the full study here. 

    Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.

    Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”

    From the U.S. healthcare business front

    Beckers Payers Issues advises

    The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members.
    Commercial includes fully- and self-insured members

    Commercial enrollment rankings in 2022:

    1. Elevance Health: 31.4 million
    2. UnitedHealth Group: 26.7 million
    3. Cigna: 22 million
    4. CVS Health (Aetna): 17 million
    5. Centene: 2.5 million
    6. Humana: 986,000

    Healthcare Dive reports

    • After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas. 
    • The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
    • In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.

    and

    Elevance has closed its deal to acquire specialty pharmacy BioPlus, the insurer announced Wednesday, after first announcing the buy in November 2022.

    The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.

    Beckers Hospital Review tells us

    Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.

    Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.

    Medly raised $100 million in 2020, positioning itself as a digital competitor to retail pharmacies such as Walgreens and CVS.

    Tuesday Tidbits

    David Ermer–CDC, CMS, COVID treatment, Electronic health records, FDA, Medicare, Mental health care, NCQA, Rx coverage, Telehealth–
    Photo by Laura Ockel on Unsplash

    From the Omicron and siblings front, HealthDay tells us

    Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows

    The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it

    Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1

    From the public health front —

    • Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
    • MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
    • The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.

    From the healthcare quality front

    • Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
    • The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.

    From the Medicare front —

    • The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
      • “Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
    • Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
    • Fierce Healthcare informs us
      • “Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
      • “Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
    • STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
      • Speaking of which, USA Today reports
        • One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
        • The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
        • Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness. 

    In hospital pricing transparency news —

    • Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
    • Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.

    From the HR department

    • The Society for Human Resource Management tells us
      • “Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
      • “All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
    • HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act? 
    • HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”

    From the tidbits department

    • Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
    • MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”