Thursday Miscellany

Telehealth

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the American Hospital Association reports

The Senate today voted 72-25 to pass and send to the House a continuing resolution that would extend current federal funding levels for health care and other programs through Dec. 16. Current government funding expires at midnight Sept. 30.

The legislation also would extend through Dec. 16 two expiring programs that help maintain access to care in rural communities: the Medicare-dependent Hospital and enhanced Low-volume Adjustment programs. AHA will continue to advocate for long-term extension of these programs. Among other provisions, the continuing resolution would reauthorize the Food and Drug Administration’s user fee programs, and provide emergency funding for Ukraine and disaster assistance.

A proposal dealing with energy-permitting plans was dropped from the measure on Tuesday, speeding passage of the legislation. The House is expected to pass the measure by Friday. 

Roll Call provides more background on the CR.

The American Hospital Association also tells us

The House voted 220-205 today to pass legislation to hold employer-based health plans more accountable for improper denials of mental health and substance use benefits. The Mental Health Matters Act (H.R.7780) would give the Department of Labor more authority to enforce plan requirements under the Mental Health Parity and Addiction Equity Act and Employee Retirement Income Security Act, ban forced arbitration agreements when plans improperly deny benefits and ensure a fair standard of review by the courts. The bill also would provide grants to develop, recruit and retain school-based mental health professionals and link schools with local mental health systems, among other provisions.

Fierce Healthcare provides more color on this troubling bill.

The ERISA Industry Committee (ERIC)—which represents large employer plan sponsors—wrote a letter Monday to all House members calling for them to oppose (PDF) the Mental Health Matters Act when it comes up for a vote later this week. The letter comes as Congress is considering how to improve pay parity between behavioral and physical health amid reports of some insurers not following requirements in the Affordable Care Act. 

“This bill includes provisions that weaponize the Department of Labor (DOL) to sue employers rather than helping them come into compliance,” the letter said. * * *

[I]t remains unclear whether the Senate will take it up. The Senate Finance Committee is considering action to tackle pay parity but so far has not released any legislation. Chairman Ron Wyden, D-Oregon, previously told Fierce Healthcare that he is still working on legislation to tackle the issue, including taking aim at “ghost networks” where providers listed in directories don’t take new patients.

Earlier this month, Healthcare Dive reported that

The Senate Finance Committee released a bipartisan-supported discussion draft bill that aims to increase mental health access and improve mental health workforce shortages.

The draft bill proposes to fill the gap in mental healthcare worker shortages by funding training for 400 additional Medicare Graduate Medical Education psychiatric slots for residencies per year beginning Oct. 1, 2024. Over a decade, 4,000 psychiatric residencies would be supported by the funding, according to the bill.

The Senate’s focus on access to care makes much more sense than the House’s punitive approach, particularly considering the unnecessary complexity of the federal mental health parity law.

From the Omicron and siblings front, MedPage Today discusses nasally administered Covid vaccines now under development. “The idea is that mucosal vaccines could bolster immunity at these viral entry points, stopping the pathogen from implanting, multiplying, and transporting itself throughout the body.” Finger crossed.

From the monkeypox front, CNBC reports

A single dose of the two-dose monkeypox vaccine provides some protection against the virus, according to CDC data.

People at risk of monkeypox who have not received a shot are 14 times more likely to get infected, the preliminary data found.

These are the first real-world findings on how well the vaccine is working in the current outbreak.

 The CDC is still recommending that everyone at risk receive two doses of the vaccine.

From the Food and Drug Administration front —

STAT News informs us

The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease.

The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

Amylyx did not immediately disclose how much it will charge for Relyvrio. “Amylyx’s goal is that every person who is eligible for Relyvrio will have access as quickly and efficiently as possible,” the company’s co-CEOs said in a statement, “as we know people with ALS and their families have no time to wait.”

Healio relates

The FDA approved bevacizumab-adcd for the treatment of six cancer types, according to a press release from the biosimilar’s manufacturer.

Bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Genentech), is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and prohibits it from binding to VEGFR-1 and VEGFR-2 on the surface of endothelial cells.

FDA approved bevacizumab-adcd for metastatic colorectal cancer; recurrent or metastatic nonsquamous non-small cell lung cancer; metastatic renal cell carcinoma; recurrent glioblastoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

In medical research news, STAT News tells us

After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply.

The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced. The cost of generating this data has dropped, too, from about $5 per billion DNA bases on Illumina’s last line of high-end sequencers to as low as $2 on the new products.

That will bring the cost of reading a whole human genome on the company’s equipment from about $600 to $200, which could help make sequencing more mainstream in everyday medicine. While the price of sequencing isn’t the only obstacle to using genomics to improve human health, it remains a major factor.

Intriguing.

From the Medicare front, the Centers for Medicare and Medicaid Services (CMS) announced 2023 Medicare Advantage plan and Part D prescription drug plan premiums in advance of the Medicare Open Enrollment, which runs from October 15 through December 7, 2022.

The projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.

[T]he average basic monthly premium for standard Part D coverage is projected to be $31.50, compared to $32.08 in 2022. 

To view the premiums and costs of 2023 Medicare Advantage and Part D plans, please visit: https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin. Select the various 2023 landscape source files in the downloads section of the webpage. 

For state-by-state information, important dates and enrollment resources for Medicare Advantage and Part D in 2023, please visit: https://www.cms.gov/files/document/2023-medicare-advantage-and-part-d-state-state-fact-sheets.pdf

For more information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation, please visit: https://innovation.cms.gov/innovation-models/vbid.

From the telehealth front, the Wall Street Journal reports a tragic story —

Cerebral treated a 17-Year-Old without His parents’ consent. They found out the day he died.
Telehealth startup didn’t use software to flag minors, according to employees and documents; company says it complies with state rules and the case is an outlier.

Anthony Kroll signed up for Cerebral in December and uploaded his Missouri intermediate driver’s license showing he was 17. Missouri law prohibits clinicians from providing mental-health treatment to people under 18 without parental consent. 

Anthony told a Cerebral clinician he had suicidal thoughts, and she prescribed him an antidepressant that carries a warning label for adolescents, according to medical records reviewed by the Journal. Cerebral didn’t notify his family. 

His parents, Wendi and Todd Kroll, said they didn’t know their son was suicidal or was seeking mental-health treatment. “I had no idea he was even on [medication] until the day he died,” Mrs. Kroll said, adding that she found the pill bottle at their home a few hours before her son died by suicide.

A Cerebral spokesman said Anthony misrepresented his age, the company regrets he received care without parental consent, and the treatment he received was appropriate. “This case is an unfortunate outlier,” the spokesman said. “Any loss of life is tragic, and we extend our deepest condolences to the family.” 

From the miscellany department

  • The GAO released a report titled “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics.” ” Machine learning technologies can help identify hidden or complex patterns in diagnostic data to detect diseases earlier and improve treatments. We identified such technologies in use and development, including some that improve their own accuracy by learning from new data. But developing and adopting these technologies has challenges, such as the need to demonstrate real-world performance in diverse clinical settings.”
  • Federal News Network tells us

Agencies may soon get some more specific guidance on how best to implement President Joe Biden’s sweeping executive order on diversity, equity, inclusion and accessibility in the federal workforce.

The Chief Diversity Officers Executive Council, a governmentwide panel composed of agencies’ chief diversity officers and led by the Office of Personnel Management, held its first-ever meeting on Sept. 29.

“This has been a really long time coming,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

Tuesday’s Tidbits

David Ermer–CMS, Congress, Medicare, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports

Sen. Joe Manchin (D., W.Va..) on Tuesday threw in the towel on including his contentious proposal to speed up permitting of energy projects in a must-pass funding bill, clearing the way for the Senate to advance the legislation needed to keep the government open. 

With the permitting language out, the Senate voted 72 to 23 to advance the stopgap bill, which would extend current government funding levels until Dec. 16 and prevent a partial shutdown this weekend, when the fiscal year ends. The bill now moves to final passage in the Senate and will also need approval in the House, which returns Wednesday, before heading to President Biden’s desk. * * *

The resolution would also reauthorize the Food and Drug Administration’s user-fee agreements for prescription drugs, generic drugs and medical devices, preserving their access to U.S. patients. The legislation has to pass by the end of September to avoid funding gaps for the FDA.

The resolution includes funding for assistance to Ukraine but not for Covid and monkeypox expenses, also requested by the White House.

From the monkeypox front, STAT News reports that responding to the disease is stretching thin the resources of public health clinics serving the LGBTQ+ communities.

Today was filled with surprises.

  • The Centers for Medicare and Medicaid Services beat OPM to the punch by announcing 2023 Medicare Part B premiums before OPM announced 2023 FEHB and FEDVIP premiums. “The standard monthly premium for Medicare Part B enrollees will be $164.90 for 2023, a decrease of $5.20 from $170.10 in 2022. The annual deductible for all Medicare Part B beneficiaries is $226 in 2023, a decrease of $7 from the annual deductible of $233 in 2022.”
  • BioPharma Dive reports “In a surprise result, Alzheimer’s drug from Eisai and Biogen shows benefit in a large trial; The drug, called lecanemab, met the study’s main and secondary goals, reducing clinical decline [by 27%] over 18 months compared to a placebo.” The announcement’s timing is exquisite because, for 2022, CMS jacked up the Medicare premiums in anticipation of massive costs from what turned out to be a failed Alzheimer’s drug, Aduhelm, also from Biogen. The popping of the Aduhelm balloon resulted in the Medicare Part B premium and deductible decreases for 2023. FEHB carriers need to keep an eye on this drug’s progress because FEHB plans have large cadres of annuitants with Part A but not Part B due to IRMAA.

From the No Surprises Act front, the American Hospital Association reports

The AHA, American Medical Association and Medical Group Management Association today urged the Centers for Medicare & Medicaid Services not to include a convening/co-provider framework when implementing the Advanced Explanation of Benefits and insured good faith estimate provisions under the No Surprises Act. The groups urged the agency to instead allow each billing provider to submit their own good faith estimate to the health plan to create an AEOB; and to leverage existing provider and health plan workflows, standards and technologies for claim submission and adjudication to support accurate AEOBs for patients.

“Our organizations appreciate the opportunity to work with CMS on the No Surprises Act’s price transparency provisions implementation, and we are committed to working closely with our members to ensure that they have the information and tools to successfully implement the new requirements,” the letter adds. “Additionally, we remain committed to ensuring that patients have access to complete and accurate out-of-pocket cost information for scheduled care and working with you to develop efficient methods of delivering this information.”

This sensible idea would align the GFI with regular EOBs, thereby facilitating the use of electronic claims technology.

From the benefit design front, Fierce Healthcare reports

Walmart, the largest employer in the U.S., is teaming up with fertility startup Kindbody to offer benefits under its insurance plan that will help its workers expand their families.

Walmart Associates and their dependents who are enrolled in a self-insured Walmart medical plan will now have access to Kindbody’s services including fertility assessments and education, fertility preservation, genetic testing, in vitro fertilization (IVF) and intrauterine insemination (IUI).

Walmart’s employees will have access to more than 30 state-of-the-art Kindbody clinics across the U.S., including a new clinic and IVF lab in Rogers, Arkansas that will provide comprehensive virtual, at-home and in-clinic care. The new facility is expected to open later this year.

The expanded services build on Walmart’s Center of Excellence (COE) model, which provides benefit support and coverage for certain heart, spine and joint surgeries and cancer treatments.

“Providing access to high-quality health care is very important to us, and we’ve heard from our associates that improved access to fertility, surrogacy and adoption support is a priority for them and their families,” said Kim Lupo, senior vice president, Walmart Global Total Rewards in a statement. “Through Kindbody, Walmart associates in every corner of the country will have access to a variety of services to aid in their family-planning journey.

From the studies/research department

  • Beckers Payer Issues informs us, “Alabama, Hawaii, Florida, New York and New Jersey are the states with the highest incidences of low-value care, a new study published in Health Affairs found.”
  • The National Institutes of Health (NIH) announced “a new program to better understand the function of every human gene and generate a catalog of the molecular and cellular consequences of inactivating each gene. The Molecular Phenotypes of Null Alleles in Cells (MorPhiC) program, managed by the National Human Genome Research Institute, aims to systematically investigate the function of each gene through multiple phases that will each build upon the work of the previous.” Wow.
  • NIH also tells us, “People with opioid use disorder who received telehealth services during the COVID-19 pandemic were more likely to stay on their medications and less likely to overdose. The findings support continuing the expanded telehealth access that began during the pandemic.”

From the tidbits department

  • The US Preventive Services Task Force today reaffirmed an A grade recommendation for screening for syphilis infection in asymptomatic, nonpregnant adolescents and adults who are at increased risk for infection. The initial recommendation for this screening was made in 2016.
  • Beckers Health IT explores the significant business benefits of United Healthcare’s recent antitrust litigation victory, which allows UHC’s acquisition of change healthcare to proceed.
  • Healthcare Dive reports

The American Hospital Association, along with a coalition of other healthcare organizations, wants the HHS to postpone an information blocking deadline slated to start Oct. 6, according to a Monday letter sent to Secretary Xavier Becerra.

By that date, providers, health IT developers and others must start sharing all electronic protected health information in a designated record,effectively prohibiting entities from information blocking.

The groups warn they’re not prepared to meet the deadline and are struggling to interpret a clear definition of electronic health information or technical infrastructure to support secure exchanges, according to the release.

 

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, No Surprises Act, Telehealth–

From Capitol Hill, Healthcare Dive reports

A group of 375 organizations sent a letter to the Senate on Tuesday urging lawmakers to act to pass legislation extending COVID-19-era telehealth flexibilities for another two years.

The letter was led by health IT and telehealth lobbies, but also joined by a number of health systems including Ascension and Cleveland Clinic, physician groups including the American Medical Association, tech companies including Amazon and Google and large employers including Walmart.

Without action, the policies — which threw open the doors to telehealth and led to skyrocketing utilization in the early days of the pandemic — will expire 151 days after the end of the COVID-19 public health emergency.

Health Payer Intelligence adds that according to a recently conducted survey on consumers enrolled in employer-sponsored health plans commissioned by AHIP:

First, most consumers across the political spectrum agreed that providers should not be permitted to charge unnecessary administrative fees and medical services mark-ups. Nearly eight out of ten respondents said that they supported this statement (78 percent), with three-quarters or more in each political party reporting this response.

Second, there was also strong bipartisan support for protections against hospital monopolies. Over three-quarters of consumers supported preventing hospitals from consolidation, mergers, and acquisitions that involved bringing other medical practices into one hospital system (76 percent). Consumers also indicated support for protections against site-based cost increases (75 percent).

Respondents wanted more transparency about healthcare deals. Slightly more than seven in ten consumers supported improving transparency around private-equity firms’ healthcare acquisitions.

Third, the researchers also found bipartisan alignment around telehealth. Slightly more than two-thirds of respondents agreed that the government should eliminate regulatory barriers to telehealth utilization (67 percent).

“Consumers value choice and flexibility in how they access health care. Telehealth proved to be an essential resource for consumers throughout the COVID-19 pandemic and should continue to play a role in the future of health care,” the survey stated.

To provide context, Beckers Hospital CFO Report informs us

HHS is set to extend the COVID-19 public health emergency [PHE] by its standing deadline of Oct. 13. 

HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days’ notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days’ notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.

If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023. * * *

For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.

In No Surprises Act news yesterday, the NSA regulators issued a request for information (RFI) from stakeholders and the general public. The RFI concerns the law’s requirement that health plans provide an advance explanation of benefits (AEOB) in response to a good faith estimate (GFE) of healthcare costs requested by the patient to their healthcare provider. The provider would submit the GFE request to the health plan. HIPAA governs many similar claims transactions involving providers and payers. Surprisingly, Congress did not add these claim transactions to HIPAA, which would have made perfect sense. The FEHBlog does not understand why the regulators have not asked Congress to take this necessary step. At first glance, the contemplated process strikes the FEHBlog as unnecessarily complicated if the object is to avoid patient surprises. Nevertheless, at least the regulators are seeking public input.

From the Omicron and siblings front, the National Institutes of Health announced

A research team funded by the National Institutes of Health has shown that commercially available rapid antigen tests can detect past and present variants of concern and has identified potential mutations that may impact test performance in the future. As new variants of the SARS-CoV-2 virus continue to emerge, concerns have been raised about the performance of rapid antigen tests.

The team, which was funded by NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, developed a method to evaluate how mutations to SARS-CoV-2 can affect recognition by antibodies used in rapid antigen tests. Since most rapid antigen tests detect the SARS-CoV-2 nucleocapsid protein, or N protein, the team directly measured how mutations to the N protein impacted diagnostic antibodies’ ability to recognize their target.

“Rapid antigen tests remain an important COVID-19 mitigation tool, and it is essential to ensure that these tests can detect the SARS-CoV-2 virus as it continues to evolve,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for the RADx Tech program at the NIH. “Considering the endless cycle of new variants, the data from this study will be useful for years to come.”

From the healthcare technology front, Fierce Healthcare informs us

[Cigna’s] Evernorth is expanding its digital health formulary yet again, adding five new solutions to the platform.

The formulary will now include Big Health’s Sleepio for insomnia and the tech company’s Daylight tool for anxiety. In addition, Evernorth said it will expand inclusion of Quit Genius’ tools to its platforms for alcohol use disorder and opioid use disorder.

Lastly, Evernorth will now include HealthBeacon’s Injectable Care Management System for inflammatory conditions, which is meant to assist patients in managing injectable medications. Glen Stettin, M.D., chief innovation officer at Evernorth, told Fierce Healthcare that all of the new tools fit key concerns for employers and plan sponsors, such as mental health and high-cost inflammatory conditions.

“Our clients care about areas where either lots of people need help and treatment or where they’re spending lots of money,” Stettin said.

From the federal employee benefits front, benefits expert Tammy Flanagan writing in Govexec discusses how federal employees should time their retirement.

Thursday Miscellany

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

From the omicron and siblings front, AHIP informs us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the bivalent mRNA COVID-19 vaccines as a single-dose booster for all individuals ages 12 and older (Pfizer-BioNTech) and 18 and older (Moderna), at least two months following primary series or previous booster dose.  The ACIP recommendation for the bivalent boosters was approved by a vote of 13-1.

The Committee reviewed modeling data showing the vaccine has the potential to reduce hospitalizations and deaths, especially among high-risk groups.  The bivalent boosters are recommended for all those over age 12 who have completed a primary series, at least 2 months after the most recent dose. The modeling data indicates that the vaccine is safe and effective, and that booster strategies will be executed in an equitable manner.  Models also indicate that waiting until more trial data is available (in two to three months) could lead to preventable hospitalizations and deaths.

ACIP members expressed concern that many assumptions had been made with the modeling, and that the vaccine being recommended – which includes protections specific to the BA.4/BA.5 variants – has not been tested in humans.  Mouse models were used for data on this vaccine, in addition to extrapolations from human trials using the BA.1-specific vaccine. CDC pointed out that annual influenza vaccines are modified based on projected variants without direct clinical evidence. ACIP members also expressed concerns that the bivalent booster makes assumptions about future variants, which this booster may not protect against.

Earlier this week, the Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for both the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent Moderna vaccine is authorized for use as a single booster dose in individuals 18 years of age and older and the Pfizer bivalent vaccine is authorized for use as a single booster dose in individuals 12 years of age and older.  FDA also released fact sheets on both the Pfizer-BioNTech vaccine and the Moderna vaccine.

With the authorization, FDA has revised the EUAs to remove the use of the monovalent versions of the vaccines for booster administration for the age groups now covered by the bivalent booster products. ACIP also rescinded its recommendations for the monovalent booster vaccines.

Bivalent boosters may be available as early as next week.

The FEHBlog finds it noteworthy that the new bivalent booster replaces the monovalent booster.

STAT News offers FAQs on the new boosters.

STAT News also discusses the Omicron outlook for this autumn.

In a way, some physicians have said, Covid is becoming more like the other respiratory pathogens that most of us shake off but that can occasionally cause severe illness and death among the oldest adults or people who are already sick. So many more people are dying from Covid than from those other viruses, however, because of the massive number of cases that are still occurring overall.

Another trend that has continued into 2022 has been the racial and ethnic disparities associated with Covid. The gaps between different demographic groups’ death rates have shrunk over time, but at the peak of this summer’s wave, for example, death rates by age group among Hispanic adults were notably higher than those among white adults, federal data indicate.

One of the silver linings of the pandemic is that, unlike with some viruses, SARS-2 did not pose a particularly serious threat to children. That’s not to minimize the hospitalizations and deaths — as well as incidents of long Covid and MIS-C — that the virus did cause in pediatric populations. But overall, kids have faced much lower risks of severe outcomes from Covid than adults.

Still, something worrisome occurred this summer with kids and Covid, as hospitalizations reached their second highest peak of the entire pandemic, surpassing last summer’s Delta wave and only trailing the initial Omicron spike early this year.

The article’s experts encourage vaccinating children to stem this tide.

From the FEHB front, Govexec provides a handy just before and just after federal retirement checklist, and Fedweek helpfully delves into “What Counts and What Doesn’t for Keeping FEHB Coverage in Retirement,” which should be a key consideration for career feds.

From the public health front, the CDC reminds us September is Sepsis Awareness Month

Anyone can get an infection, and almost any infection, including COVID-19, can lead to sepsis. Sepsis is the body’s extreme response to an infection and is a life-threatening medical emergency.

September is Sepsis Awareness Month and CDC encourages patients and healthcare professionals to share Get Ahead of Sepsis resources, below, to learn how to protect themselves, their loved ones, and their patients from sepsis:

Patients and families:
* New this year is an updated patient and family brochure.
* Download and share any of CDC’s FREE patient education materials with your friends and loved ones to learn how to prevent infections, be alert to the signs and symptoms of sepsis, and act fast if sepsis is suspected.
* Share updated sepsis graphics on social media to educate friends and loved ones about sepsis.
* Are your children back to school? Talk to your child’s healthcare professional and school nurse about steps you can take to prevent infections that can lead to sepsis. Some steps include taking good care of chronic conditions and getting recommended vaccines.
Healthcare professionals:
New this year are two fact sheets for long-term care nurses and certified nurse assistants.
Download and share CDC’s FREE healthcare professional education materials with your colleagues to educate them about how to recognize signs and symptoms of worsening infection and sepsis, how to get ahead of sepsis, and what to do if they suspect sepsis.
Educate your patients and their families about:
o Preventing infections
o Keeping cuts clean and covered until healed
o Managing chronic conditions
o Recognizing early signs and symptoms of worsening infection and sepsis
o Seeking immediate care if signs and symptoms are present

This Sepsis Awareness Month, spread the word about sepsis—you can help save lives.

To learn more about sepsis and how to prevent infections, visit www.cdc.gov/sepsis or call 1-800-CDC-INFO.

From the miscellany department —

  • Medpage Today offers a special report about a ” New Behavioral Health Database Reveals Gaps in Care — Researchers behind it hope to provide the data needed to remedy the problem.”
  • STAT News reports “Drug treatment of veterans with opioid use disorder increased during the first year of the pandemic, according to a new study, suggesting that the rapid shift from in-person to telehealth visits at VA medical centers enabled patients to get access to care despite Covid-related disruptions.”
  • Fierce Healthcare tells us “Cigna’s Evernorth subsidiary is expanding its diabetes care value program to combine traditional pharmaceutical interventions with devices, tools and resources to help patients better understand and manage their diabetes.”
  • Healthcare Dive informs us that “To staunch the losses of rural hospital closures that endanger access to care for millions, federal regulators are hoping some facilities opt in to a new payment model, but providers say they want more flexibilities and clarity before making the pivot. * * * The new rule ‘maybe gets halfway there,’ Jennifer Findley, vice president of education and special projects at the Kansas Hospital Association, told Healthcare Dive. ‘It’s not as much as we were hoping for but it does give some more flexibility than what you have today.’”
  • Health Payer Intelligence reports “Chronic diseases are common among emergency department patients, particularly among seniors and those ages 45 to 64, according to a National Health Statistics Report. ‘Monitoring ED visits made by adults at highest risk of severe COVID-19-related illness is important for understanding the health burden of COVID-19 and for planning prevention strategies,’ the researchers explained. ‘Ongoing monitoring of the presence of these underlying chronic conditions at ED visits will continue to inform COVID-19 response efforts.’”
  • Also Health Payer Intelligence notes that “Three major social determinants of health factors are particularly predominant barriers to care for America’s seniors: economic instability, loneliness, and food insecurity, according to a study sponsored by Alignment Healthcare. Researchers from Toluna conducted an online survey from July 24 to August 13, 2022, which reached 2,600 seniors ages 65 and older. Most respondents identified as white. Half were in Medicare Advantage and this population was divided primarily between preferred provider organizations and health maintenance organizations.”

Weekend update

David Ermer–Congress, COVID-19, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Congress is on a State / District work break again this week.

The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.

Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.

Here’s a link to a Fierce Healthcare article on the new rules.

From the omicron and unusual viruses front —

The Wall Street Journal reports

The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.

But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.

As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S. 

This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.

The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce. 

The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.

Fingers crossed.

On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.

NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. 

The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.

The Wall Street Journal offers articles on “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York” and “Am I Protected Against Polio? Here’s What to Know About the Vaccine.”

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.

The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.

Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.

Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.

STAT News adds

Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.

Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.

CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.

There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.

From the miscellany front

  • Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization.  The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
  • Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, NIH, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Federal News Network identifies five federal workforce items on Congress’s to-do list.

From the omicron and siblings front, the Wall Street Journal reports

The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come. * * *

Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months, an HHS spokesman said.  * * *

Switching vaccine purchasing to the commercial market would mean that each insurer and pharmacy benefit manager would be negotiating with drug manufacturers and prices would likely be higher than what the federal government has paid, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. Insurers would have to start paying for the vaccines, he said, likely raising premiums.

MedPage Today informs us

More than 2 years after patients started reporting long-lasting symptoms after acute SARS-CoV-2 infection, the U.S. announced its national long COVID plan.

The National Research Action Plan on Long COVID aims to improve prevention, diagnosis, and treatment for long COVID, which currently affects up to 23 million people in the U.S., about 1 million of whom may be out of the workforce at any given time because of the condition, according to Admiral Rachel Levine, MD, HHS assistant secretary for health. * * *

Long COVID advocates expressed mixed opinions. Hannah Davis, co-founder of the Patient-Led Research Collaborative, noted the fact that “there’s going to be an [Office of Long COVID Research and Practice] is pretty amazing.”

But Davis voiced concerns about the scarcity of prevention efforts addressed by the plan. “I think there’s still a feeling like we can get through this without minimizing cases, but we really need to be focused on prevention as well,” she said.

Diana Berrent, founder of Survivor Corps, told MedPage Today that the administration “nailed the institutional challenge of long COVID” but also thought the plan was insufficient.

“Millions of Americans, young and old, are suffering the aftermath of COVID and need immediate relief from their pain,” Berrent said. “An established office in HHS is a welcome step but nothing short of actual treatments and therapeutics will do the trick.”

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of monkeypox cases, and MedPage Today reports

The Biden administration is making an additional 1.8 million doses of the Jynneos monkeypox vaccine available beginning Monday, and will be targeting certain large events — such as gay pride marches that attract many LGBTQIA participants — as sites for monkeypox vaccination and outreach, administration officials said Thursday.

From the healthcare costs front, Healthcare Dive reports

U.S. employers will pay 6.5% more on average for employee healthcare coverage in 2023 compared to this year, according to an Aon report out Thursday.

The latest predicted rise, while a jump from the 3.7% growth in employer costs between 2021 and 2022, is still far below the 9.1% Consumer Price Index, a figure reflecting inflation. 

Inflation typically hits healthcare costs later than other goods and services due to the multi-year nature of contracts between providers and insurers, but impacts will become more prevalent over the year, according to the report.

Speaking of higher costs, Fierce Healthcare discusses Moody’s report on how an economic downturn would impact health plans.

From the post-Dobbs front, the FEHBlog ran across this Congressional Research Service FAQs on Federal Resources for Reproductive Health.

From the No Surprises Act front, the American Hospital Association informs us “The Centers for Medicare & Medicaid Services has launched a new webpage with resources and guidance related to the dispute resolution process under the No Surprises Act, including guidance for disputing parties and a walkthrough of the federal portal. CMS also has added functionality to the portal for initiating disputes, including a button to upload supporting documents at initiation.”

From the miscellany department —

  • Fierce Healthcare discusses J.D. Powers’ annual study of Medicare Advantage plans. “[T]he analysts found members’ general satisfaction is up from 2021 and is higher than satisfaction reported by people in employer-sponsored plans. However, while members said they’re happy with access to preventive and routine care, coverage of mental health and substance abuse treatment is lacking.”
  • STAT News calls our attention to “a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.” According to the article, “When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.”

Midweek update

David Ermer–Congress, COVID-19, COVID-19 testing, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Capitol Hill front, Health Affairs Forefront offers articles from

  • Prof. Katie Keith on the Affordable Care Act provisions in the budget reconciliation bill (H.R. 5376) that the House of Representatives will take up on Friday, and
  • Prof. Rachel Sachs on the Democrats’ drug pricing proposal in that bill.

The FEHBlog found information in Prof. Sachs’ article about the proposed $35 cap on insulin copayments.

[T]he IRA was drafted to include a $35 out-of-pocket cap on insulin not only for Medicare beneficiaries, but also for privately insured patients. The parliamentarian ruled that the application of this out-of-pocket cap to privately insured patients did not comply with the reconciliation rules. Rather than unilaterally remove this provision (as the Democrats did with the inflationary rebate provision), Democrats chose to advance the bill with the provision included. Republican Senators then chose to challenge its inclusion, and 43 Republicans voted to strip the $35 out-of-pocket cap for privately insured patients from the bill, enough to result in its removal. (Although seven Republicans voted with all 50 Democrats to keep the cap, the provision needed 60 votes to remain in the bill.)

The Hill adds “Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on [non-Medicare] patients’ insulin costs back up for a vote this fall after Republicans blocked it over the weekend.”

Roll Call discusses the cost shifting between Medicare and other insurance programs, including the FEHBP, once the law is enacted and takes effect. Medicare does not negotiate prices with providers; it sets them.

Govexec informs us

President Biden announced on Wednesday his intent to appoint a prominent surgeon and professor who has been at the vanguard of advances in cancer treatment to lead the federal government’s main agency for cancer research and training. 

The president will appoint Dr. Monica Bertagnolli to be director of the National Cancer Institute, part of the National Institutes of Health, which has about 4,300 employees and had a $6.35 billion budget in fiscal 2021. She is currently the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute, a top cancer hospital. Bertagnolli will be the first woman to hold this position.

“Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology, advancing, in particular, current understanding of the gene that promotes gastrointestinal cancer development,” said an announcement from the White House. “As a physician-scientist, she led gastrointestinal science initiatives from 1994 to 2011 within the [National Cancer Institute]-funded Cancer Cooperative Groups.” She also served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center from 2007 to 2018. 

Good luck, Dr. Bertagnolli.

From the omicron and siblings front, Forbes reports

Pfizer and BioNTech have completed clinical trials for vaccines that include specific protection against the original omicron variant. Now the two companies have begun testing for vaccines specific to the BA.4 and BA.5 Omicron subvariants, which are the fastest spreading variants of Covid-19 in the United States. Manufacturing for the new vaccines has already begun, and could be rolled out as early as October pending regulatory approvals. That’s good news as we approach the fall and winter, which have been the times of year where Covid spread is at its highest. Competitor Moderna has also begun testing an omicron-specific booster, but the FDA has not yet authorized any Omicron-specific vaccines.   

and

Researchers have identified monkey antibodies that are effective against numerous Covid variants and other coronaviruses, a discovery that could help scientists develop better vaccines and prepare for future pandemics as pharma firms race to update their shots.

If the monkey antibodies research is successful, then the WHO definitely should change monkeypox’s name.

From the medical research front, STAT News tells us

With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month.

By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.

The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — though not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.

Fingers crossed for a successful outcome.

From the U.S. healthcare business front, Fierce Healthcare reports

Amazon Care, which currently offers virtual health visits, in-person primary care visits at patients’ homes or offices and prescription delivery, is adding behavioral health care to its slate of services.

Amazon’s health service business plans to team up with teletherapy startup Ginger as an optional add-on to Amazon Care. Through the partnership, Amazon Care users will be connected to Ginger’s on-demand mental health services including behavioral health coaches, licensed therapists and psychiatrists, according to a live website about the service. * * *

The new service hasn’t launched yet, according to people familiar with the matter, Business Insider reported.

As an aside, Smart Brief discusses telemedicine in pediatrics.

Fierce Health also tells us

A company with a long history of providing medical supplies for chronic conditions is expanding its business into monitoring and coaching services for diabetes patients.

CCS, which now includes CCS Medical and CCS Health, aims to provide a more integrated experience for chronic care management, Tony Vahedian, CEO of CCS, said in an interview. * * *

“We believe we’re in the appropriate position to really take that fragmented experience and make it an integrated, seamless experience because not only can we deliver the products at the time, but we also can coach them and provide that clinical care,” the CEO noted. CCS can combine its home-delivered medical supplies business with accredited clinicians supported by proprietary data and technology to simplify the patient experience, he added. 

The company supports more than 200,000 patients living with chronic conditions in the U.S. and delivers more than 1.2 million shipments of medical supplies to patients in their own homes.

From the nudging front, Health Payer Intelligence shares another survey illustrating that participants in employer-sponsored health plans need more help with health plan literacy.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, HSA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition. * * *

Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.

That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.

The settlement would also loosen a rule that had limited the Blue insurers’ ability to compete with one another for the business of large national employers. Under the changes, certain national employers would be able to also request a bid from a second Blue insurer of their choice, setting up competition between the two Blues.

However, the settlement stops short of unwinding the Blues’ licensing setup that grants exclusive geographic branding rights to companies—the main original focus of the litigation. * * *

A spokeswoman for the Blue Cross Blue Shield Association said it was pleased with the approval, and is committed to finalizing and implementing the agreement.

The settlement should be implemented beginning in 30 days. There are limited appeal rights for class members. The Journal adds, “The Blue insurers still face a second, parallel antitrust suit filed on behalf of doctors, hospitals and other healthcare providers.”

From the Omicron and siblings front, the New York Times offers advice on how to manage Omicron BA.5 symptoms, including sore throats, from home.

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of U.S. monkeypox cases and offers physician perspectives on the monkeypox cases that they are treating. “‘The biggest misconception is that this is always a mild disease,’ Jason Zucker, MD, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, said during an Aug. 5 call with reporters.”

Govexec reports that the FDA implemented its plan to significantly extend the supply of the preferred monkeypox vaccine. Bloomberg Prognosis provides more medical details on this development.

From the Rx coverage front, Fierce Healthcare discusses Optum’s latest drug development pipeline report and STAT News reports

For only the second time, Pfizer is offering a warranty for a medicine that will cover the cost for any patient or health plan if the medication fails to work, a move that expands an effort to appease concerns about high drug costs.

The newest warranty program began last month and covers Panzyga, which was approved last year in the U.S. to treat a rare neurological disorder called chronic inflammatory demyelinating polyneuropathy, or CIPD. Patients can get repaid for four treatments — up to $16,500 each, or a maximum of $50,000 — if use is discontinued for clinical reasons. And insurers can also get reimbursed for their own outlays.

Unlike the first warranty program — which Pfizer began a year ago for its Xalkori lung cancer treatment — this newest warranty is only available to patients who are covered by commercial insurance or pay cash, not government health care programs.  The Xalkori program is available to patients who are covered by commercial insurance or those who pay cash but are also covered by Medicare.

And how about an Rx coverage tidbit? Bayer tells us with understandable pride

This year, acetylsalicylic acid (ASA), the active ingredient that brought Aspirin to fame, celebrates its 125th anniversary. On August 10, 1897, Dr. Felix Hoffmann discovered the ideal formula for acetylsalicylic acid when he synthesized the first chemically pure and stable form of acetylsalicylic acid. * * *

Hoffmann’s breakthrough was entered in the trademark register of the Imperial Patent Office in Berlin in 1899 and received a patent in the USA the following year, and scientists continue to conduct research even to this day on Aspirin, other potential areas of application, and dosage forms. In 1969, the round tablet made its way to the moon with the astronauts in the Apollo 11 capsule.

From the U.S. healthcare business front, MedCity News examines CVS Health’s expansion into the primary and homecare markets.

From the plan design front,

  • AHRQ’s Medical Expenditure Panel released a survey on trends in health insurance at private employers, 2008 – 2021.
  • The International Foundation of Employee Benefit Plans offers four steps for evaluating your plan’s diabetes coverage.
  • The Congressional Research Service updated its health savings account report.

From the telehealth and fraud, waste and abuse fronts

Healthcare Dive informs us

More patients turned to telehealth to see a doctor in May than April, in step with an increase in COVID-19 cases reported to the Centers for Disease Control and Prevention, according to Fair Health’s latest monthly tracker of private insurance claim lines.

Virtual visits rose 10.2% in May, accounting for 5.4% of all medical claim lines in the month, compared to 4.9% in April, Fair Health said Monday. It was the second straight month that telehealth’s share of claims grew.

COVID-19 made the list of top five telehealth diagnoses in every region of the country in May, holding in the No. 2 spot in the Northeast while climbing to second place in the Midwest and West and third place in the South.

STAT News delves into how telehealth fraud concerns could impact the industry’s future.

In Postal Service news, Federal News Network reports that USPS is eyeing mail price increases for January 2023.

USPS Chief Financial Officer Joe Corbett said the agency remains “in a financial hole,” and that more progress under the 10-year reform plan is needed.

“While we have accomplished a tremendous amount executing on the [Delivering for America] plan, we still have a lot of work to do. We need to continue executing the management initiatives in our Delivering for America plan to fill this hole and return to Postal Service to continuous self-sustaining financial health,” Corbett said.

[Postmaster General] DeJoy said USPS contributions to the retirement health care plan for its employees, under Postal Service Reform Act, will resume in 2026, and will grow to about $6.7 billion a year.

“We will not be able to make these payments unless we timely engage and accomplish all our initiatives, and we are trying to do just that,” DeJoy said.

Thursday Miscellany

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

From Capitol Hill, Roll Call reports

The Senate is expected to begin consideration of Democrats’ climate, tax and health care package on Saturday, leaving about two days for the party to shore up support for the bill.

Senate Majority Leader Charles E. Schumer said Thursday that he’s expecting a vote on the motion to proceed Saturday afternoon, which would follow a nomination vote he scheduled for 12:30 p.m.

The motion to proceed is a simple majority threshold; no Republicans are expected to back it. 

If Democrats can secure the votes to move forward, it would trigger up to 20 hours of debate before a “vote-a-rama,” when senators can offer unlimited amendments and motions to delay the process. The debate time is equally divided between the parties and senators on either side can choose to yield back time in order to get to the vote-a-rama quicker. 

It remained unclear Thursday afternoon whether party leaders had secured crucial backing from Sen. Kyrsten Sinema. * * *

Democrats are also working to wrap up the “Byrd bath,” in which the Senate parliamentarian hears arguments from both parties and issues opinions on whether provisions meet conditions of the budget reconciliation rules. Reconciliation allows the bill to avoid a filibuster and pass with only Democrats’ votes in the 50-50 Senate. * * * [Sen.] Sinema is expected to wait for the process to play out before making her position on the package known.

While the FEHBlog was writing this post, Politico reports

Sen. Kyrsten Sinema announced on Thursday night that she’s signed off on Democrats’ climate, tax and health care legislation after securing a handful of changes. 

The Arizona Democrat was not consulted during July’s dealmaking between Senate Majority Leader Chuck Schumer and Sen. Joe Manchin, but after changes to several tax provisions she okayed the agreement on Thursday. “We have agreed to remove the carried interest tax provision, protect advanced manufacturing, and boost our clean energy economy in the Senate’s budget reconciliation legislation. Subject to the Parliamentarian’s review, I’ll move forward,” Sinema said.

From the Omicron and siblings front

The New York Times explores the question “Is This What Endemicity Looks Like?” The article points out “The basic footprint of the disease has been consistent for a few months.”

We’ve been at roughly the same number of hospitalizations and deaths in the country since the end of the initial Omicron wave in the winter. And because so much of that has to do with how much better our immune systems are working against Covid than in the past, there’s probably no reason to think that those dynamics are going to dramatically change unless there’s an out-of-left-field new variant like the original Omicron.

And I think that fits the layperson’s understanding of what an endemic disease is: It’s circulating, but it’s sort of in the background, and while there are some little peaks and some little valleys, they aren’t so dramatic that they threaten to really upend life at a community level, let alone at a national level. That’s a pretty fair description of where we are right now.

While Omicron remains a dangerous virus, particularly for the elderly, which of course is where we started, we now have vaccines against severe illness and treatments for the virus.

It’s worth reading the article.

MedPage Today tells us

Most patients with smell or taste dysfunction related to COVID-19 reported complete recovery of their senses at 2 years, according to a cross-sectional survey conducted in Italy.

Among 119 patients with smell or taste dysfunction within 4 weeks of COVID onset, 88.2% reported complete resolution at 2 years, 9.2% reported a decline in symptom severity, and 2.5% reported unchanged or worsening symptoms, said Paolo Boscolo-Rizzo, MD, of the University of Trieste, and colleagues.

MedPage also offers us some Omicron miscellany

The CDC may relax guidance for COVID-19 control, including for schools, possibly as early as this week. (CNN)

And Los Angeles schools plan on updating COVID-19 protocols for the upcoming school year by dropping “overly aggressive” testing, masking, and vaccination requirements. (KTLA).

From the monkeypox front,

NPR reports

The White House today declared monkeypox a public health emergency. 

“We are prepared to take our response to the next level in addressing this virus and we urge every American to take monkeypox seriously,” Health and Human Services Secretary Xavier Becerra said to reporters during a briefing on Thursday. 

A public health emergency can trigger grant funding and open up more resources for various aspects of a federal response. It also allows the Secretary to enter into contracts for treatments and other necessary medical supplies and equipment, as well as support emergency hospital services, among other things. Public health emergencies last for 90 days but can be extended by the Secretary.

CDC Director Rochelle Walensky, said the declaration will provide resources and increase access to care. She also said it will expand the CDC’s ability to share data.

STAT News adds

Also Thursday, FDA Commissioner Robert Califf announced the agency was considering allowing Bavarian Nordic’s Jynneos, the only vaccine licensed in the United States to prevent monkeypox, to be given in two doses that are one-fifth the size of the licensed doses, via intradermal administration. Doing so could allow five times as many people to be vaccinated with existing supplies than if the licensed dosage was employed.

The vaccine is licensed as a two-dose product, with the doses administered via intramuscular injection 28 days apart.

“We believe this could be a promising approach,” Califf said.

In other public health news, the Department of Health and Human Services announced

Our nation’s blood and plasma supply dropped to historic lows during the COVID-19 pandemic. While some areas of the country have seen improvement, other areas are still struggling to meet the demand. Blood and plasma are needed on an ongoing basis to treat a variety of life-threatening conditions, which is why the U.S. Department of Health and Human Services (HHS), is launching a new campaign, Giving = Living. * * *

Visit hhs.gov/givingequalsliving to learn more about the importance of donation and make an appointment at a donation location near you.

From the U.S. healthcare business front —

Healthcare Dive tells us

Cigna reported net income increased 6% year over year to $1.6 billion during the second quarter as fewer people were admitted to the hospital, had fewer surgeries and visited the emergency room less. 

The Connecticut-based insurer said medical costs for both COVID-19 and non-COVID-19 care were lower than projected. The insurer’s medical loss ratio, an important measure of how much is spent on medical care, fell to 80.7% for the second quarter. Analysts said price hikes helped the MLR, too. 

As a result of the quarterly performance, Cigna raised financial targets for the year for revenue and income from operations. 

Fierce Healthcare informs us

Telehealth company Amwell is working with CVS Health to roll out the retail drugstore giant’s new virtual primary care service.

CVS announced at the end of May plans to launch a virtual care service that gives consumers access to primary care, on-demand care, chronic condition management and mental health services. Eligible Aetna and CVS Caremark members will be able to use the virtual primary care service to access healthcare services on demand, whether at home or in a retail or community-based setting, the drug store company said.

CVS’ virtual care platform is a “consumer-centric offering designed to bring together the many elements of CVS Health ecosystem services into a single integrated experience with a unified digital front door,” Dr. Ido Schoenberg, chairman and co-chief executive officer of Amwell, said during the company’s second-quarter earnings call Thursday.

and

Elevance Health is betting big on primary care with a new nationwide partnership with Aledade.

The team-up will focus on assisting primary care practices in transitioning to value-based care, to boost health outcomes and lower costs. Independent primary care practices that are within the insurer’s network will be able to access Aledade’s suite of technology and local, in-person services.

Aledade’s platform provides the tools, support and resources that PCPs need to roll out value-based care, the companies said.

Bloomberg reports

Pfizer Inc. will spend $470 million to expand its vaccine research facilities 25 miles northwest of New York City, where the company hopes to maintain its edge in the booming field of messenger RNA, the technology behind its blockbuster Covid-19 shot. 

The drugmaker will construct a new building and renovate existing facilities on its campus in Pearl River, New York, which has been the nexus of laboratory research driving its vaccine programs, including the one for Covid in partnership with BioNTech SE.

From the substance use disorder front, NPR explains

Music festivals once frowned upon naloxone, and some banned it. But even though what’s known as harm reduction — the concept of minimizing the negative effects of illicit drug use without trying to stop it altogether — has gained acceptance, it’s far from embraced. Less accepted than naloxone among concert promoters is helping people test their drugs for fentanyl. Companies don’t want to be seen as condoning drug use. They’re also navigating a legal gray area and battling public perceptions. * * *

Overdose deaths continue to climb in the U.S. Drug fatalities topped 100,000nationwide in 2021, with two-thirds caused by synthetic opioids. This has prompted federal and state governments to try to think of new ways to combat the crisis, with the Biden administration giving $30 million to support programs that have often operated in the shadows. In the past few years, the Substance Abuse and Mental Health Services Administration also has fully embraced fentanyl test kits.

Still, many communities far beyond music festival grounds are resistant to harm-reduction strategies, especially fentanyl-testing tools. Dr. Yngvild Olsen, director of SAMHSA’s Center for Substance Abuse Treatment, said harm reduction requires an evolution in thinking, and she encourages organizations to consider harm reduction a lifesaving tool — especially when mass overdoses are possible.

From the telehealth front, Health Payer Intelligence reports

Telehealth flexibilities during the coronavirus pandemic contributed to a 26 percent spike in overall utilization of in-network outpatient behavioral health, according to a report from UnitedHealth Group.

“Prior to the COVID pandemic, telehealth was broadly viewed as a potential strategy for improving access to behavioral health care,” the report explained. 

“During the pandemic—which saw increased rates of depression, anxiety, and substance use disorder—federal and state policymakers and commercial health plans established temporary flexibilities to increase access to care, and patients and providers increased their use of virtual visits as an alternative to in-person office-based care.”

Friday Stats and More

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

Based on the Centers for Disease Controls Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases for 2022:

The CDC’s weekly review of its Covid statistics notes “As of July 27, 2022, the current 7-day moving average of daily new cases (126,272) decreased 0.9% compared with the previous 7-day moving average (127,478).”

Here is the CDC’s chart of daily trends in new Covid hospital admissions:

The CDC’s weekly review notes “The current 7-day daily average for July 20–26, 2022, was 6,340. This is a 1.7% increase from the prior 7-day average (6,231) from July 13–19, 2022.

Also, “CDC Nowcast projections for the week ending July 23, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 81.9% (95% PI 79.9-83.8%).”

STAT News reports

[New Yorker Janet] Handal and the roughly 200,000 other Americans to receive Evusheld have had to recalibrate their hopes. Although the Food and Drug Administration doubled the recommended dose to compensate, and the drug — when given along with the full complement of vaccines — still offers protection against severe disease, gone are hopes that the most vulnerable could ditch masks or return to their pre-Covid lives.

Although the problem is now eight months old, few other prophylactic drugs for people with compromised immune systems are on the horizon. Several companies have announced plans to bring forward new Covid-19 antibodies, but they virtually are all either still in animal studies or are being principally developed as therapeutics.

The absence is particularly notable given the potential size of the market: Although Evusheld has remained vastly underused, a fact some physicians attribute to its hazily defined efficacy, between 7 and 10 million Americans are immunocompromised — a huge market by drug industry standards.

Here’s the FEHBlog’s weekly chart of new Covid deaths for 2022:

The CDC’s weekly review notes “The current 7-day moving average of new deaths (364) has decreased 4.8% compared with the previous 7-day moving average (382).”

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the 50th week of 2020, when the Covid vaccination era began to the 30th week of 2022:

The CDC’s weekly review notes, “About 223.2 million people, or 67.2% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 107.9 million people have received a booster dose, but 50.1% of the total booster-eligible population has not yet received a booster dose.”

Reuters reports

The U.S. government said on Friday it agreed to a $1.74 billion deal for 66 million doses of a Moderna COVID vaccine updated for the Omicron subvariant for use in a fall and winter booster campaign ***. Combined with 105 million doses the government already agreed to buy from Pfizer Inc and partner BioNTech SE for $3.2 billion, the latest deal puts the U.S. booster dose supply at about 171 million shots. read more

In CDC Communities News

As of July 28, 2022, there are 1,474 (45.8%) counties, districts, or territories with a high COVID-19 Community Level, 1,144 (35.5%) counties with a medium Community Level, and 602 (18.7%) counties with a low Community Level. Compared with last week, this represents a moderate increase (+3.9 percentage points) in the number of high-level counties, and a small decrease (−2.11 percentage points) in the number of medium-level counties and also a small decrease (−1.74 percentage points) in the number of low-level counties. 49 out of 52 jurisdictions* had high- or medium-level counties this week. Rhode Island, New Hampshire, and the District of Columbia are the only jurisdictions to have all counties at low Community Levels.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

From the monkeypox front, the FDA provides an update on the agency’s response to this outbreak.

From the mental healthcare front —

MedPage Today brings us encouraging news

Local outpatient mental health providers are doing fine handling the increased demand from the newly launched nationwide “988” Suicide and Crisis Lifeline, despite fears that they wouldn’t be ready, according to a senior administration official.

“The states and call centers across the country absolutely rose to the increased volume that we saw,” the official said Thursday evening during a background briefing on distribution of federal grants to shore up mental health services in schools. “We can see a 45% increase in the volume of calls that came in the week of the launch, compared to the week prior, across the country — an additional 23,000 … calls, texts, and chats that came in across the lifeline.”

Healthcare Dive reports that CVS Health has appointed its first chief psychiatric officer. “Taft Parsons, MD, who has previously worked for Molina Healthcare and Henry Ford Health System, will be tasked with focusing on mental well-being for patients and will lead the Aetna Medical Affairs Behavioral Health organization.” Good luck, Dr. Parsons.

From the medical research front —

  • HealthDay informs us  “Obesity, depression, high blood pressure, asthma: These are just a few of the chronic health conditions that are now affecting almost 40 million Americans between the ages 18 and 34, new federal data shows.”
  • Mhealth Intelligence adds “While discovering new methods of care during the COVID-19 pandemic, Stanford Medicine researchers found that a smartphone app known as SkinIO is highly resourceful when detecting skin cancer among older people.”

From the telehealth front —

  • UPI reports “Using telehealth to supplement or replace in-person maternal care services, such as postpartum depression and diabetes and hypertension monitoring during pregnancy, leads to similar — and sometimes better — clinical outcomes and patient satisfaction compared to in-person care. That’s the gist of a study whose findings were published Monday in Annals of Internal Medicine.”

Finally, Health Payer Intelligence discusses a strategy for communicating relating high health plan premium increases for next year.

There are two key factors that will influence employer-sponsored health plan premiums in 2023, Jim Winkler, chief strategy officer at the Business Group on Health, told HealthPayerIntelligence by email: 

* Market inflation on prices of healthcare services

* Utilization rate of healthcare services

“Heading into 2023, employers face uncertainty in terms of the impact of market inflation on the prices of health care services and potential increases in utilization of those services,” Winkler said. 

“This all comes at a time when employers also have a heightened focus on attracting and retaining key talent while addressing the overall health and well-being needs of the workforce and their families.” * * *

“As employers prepare to communicate with their workforce, they will see that employees tend to be focused on what any cost increase means to them, both in terms of out-of-pocket costs and paycheck deductions. Employers will therefore need to assist employees on understanding how best to manage their own costs,” Winkler recommended.

Omnichannel communication with health plan members can be particularly useful for improving member engagement in employer-sponsored health plans. With omnichannel communication, payers and employers coordinate communication across multiple channels and platforms, improving the timeliness and convenience of member interactions.