The Senate returns to Capitol Hill for committee business and floor voting tomorrow. The Wall Street Journal adds “Between now and Election Day, senators are scheduled to be back in Washington for four weeks, then gone a week, and then back for two weeks in October.” The House of Representatives will be engaged in committee business but not floor voting this week. The House resumes floor voting next week.
The White House is asking Congress for $47.1 billion in emergency funding for Covid-19 and monkeypox and to back Ukraine in its war with Russia, as well as spending for natural disasters, according to administration officials.
Congress must vote on a spending bill by the end of September to avoid a partial government shutdown. Lawmakers are expected to use a stopgap funding measure that will maintain funding levels for the short term.
The White House is asking Congress to add the emergency funding on top of that, with about $22.4 billion for Covid-19 vaccines, testing programs, clinical trials and research; $4.5 billion to bolster efforts to fight monkeypox; and $6.5 billion to help areas of the country prepare for and recover from natural disasters. * * *
The emergency funds wouldn’t be paid for with new or shifted revenue, and would be new money that hasn’t been previously appropriated.
[As of last Friday, September 2] Senate Republican leadership didn’t immediately respond to a request for comment about the White House’s request for emergency funding. Spending bills require 60 votes, and in the 50-50 Senate at least 10 Republicans would need to back any bill that contained the administration’s request.
[President] Biden intends to nominate Richard Revesz, the AnBryce Professor of Law and Dean Emeritus at the New York University School of Law, to be administrator of the Office of Information and Regulatory Affairs, which is housed within the White House Office of Management and Budget. Biden has not had a permanent OIRA head since taking office.
From the U.S. healthcare business front, the Wall Street Journal reports this afternoon that CVS Health has struck a deal to purchase Signify Health:
The drugstore giant’s deal to acquire home-healthcare company Signify Health Inc., announced Monday, will add 10,000 contracted doctors and clinicians and give CVS a hand in coordinating medical care for millions of Americans.
CVS, the nation’s biggest healthcare company by revenue, said that it agreed to acquire Signify for $30.50 per share in an all-cash deal, confirming earlier Wall Street Journal reports. CVS said it expects the deal, finalized over the weekend after a sales process that drew interest from companies from Amazon.com Inc. to UnitedHealth Group Inc., to close in the first half of 2023.
CVS for years has worked to transform itself from a pharmacy chain to an integrated provider of medical services, with the biggest step being its 2018 acquisition of insurer Aetna. Initially, CVS envisioned a model centered on pharmacists, in-store clinics and a giant insurance business.
But Karen Lynch, who took over as CVS CEO last year, determined that the company needs doctors on its payroll to fulfill those ambitions. She also set out to expand CVS’s presence in home healthcare, demand for which has been rising as the U.S. population has aged.
Signify’s model is based on an analytics-and-technology platform, used by doctors that go into homes equipped with connected iPads, that allows the clinicians to assess patient needs and connect them with follow-up services.
The clinicians “operate much like Uber drivers,” said Kyle Armbrester, Signify Health chief executive. “We’re in a gig economy and this is a flexible model.”
The deal is the latest for a home-health company. Rival Walgreens Boots Alliance Inc. last week finalized a deal to purchase a majority stake in CareCentrix, Inc., another home-healthcare platform.
This spring, UnitedHealth agreed to buy LHC Group Inc., one of the country’s largest home-health firms, for about $5.4 billion. Last year, Humana Inc. agreed to take full control of home-health provider Kindred at Home. Both LHC and Kindred provide continuous home-healthcare services.
Signify has grown to serving more than 2.5 million homes from around 300,000 five years ago, said Mr. Armbrester, who is set to remain CEO of Signify Health after the acquisition.
From the public health front, NPR Shots discusses the new Covid boosters and Precision Vaccinations discusses flu shots. The FEHBlog checked chain pharmacies in his locality in Dripping Springs, TX. Flu shots are already available, and the new Covid boosters will be available mid-week.
Because it’s the beginning of the three day weekend, the Centers for Disease Control did not publish its weekly review of CDC Covid statistics. The FEHBlog values that weekly review because it complements the FEHBlog’s own Covid charts which are based on the CDC’s Covid Data Tracker and use Thursday as the first day of the week. So without further ado, here are the FEHBlog’s three Covid charts for this week, the 35th week of 2022:
It’s always worth noting that the peaks on the left sides of the top two charts reflect the grand daddy of surges, the first Omicron wave. With respect to Covid vaccines, Revcycle Intelligence reports that the American Medical Association has added eight new CPT-4 codes to its procedures manual to cover physician services for the new Covid bivalent boosters.
From the U.S. healthcare business front, the Wall Street Journal reports this evening
CVS Health Corp. is in advanced talks to acquire the home-healthcare company Signify Health Inc. for around $8 billion, according to people familiar with the matter.
CVS appears to have beat out other heavy hitters including Amazon.com Inc. and UnitedHealth Group Inc., which had been circling Signify for a deal that could be announced soon. UnitedHealth never submitted an official bid, one of the people said.
There is still no guarantee that CVS will reach a deal for Signify, which has been exploring strategic alternatives since earlier this summer.
While Signify’s deadline for bids is Tuesday, September 6, Signify could strike a deal before then.
UHC is not sitting on its hands though. According to MedPage Today
UnitedHealth Group’s healthcare services division, Optum, will reportedly acquire Kelsey-Seybold for approximately $2 billion, according to the Star Tribune.
The acquisition of Kelsey-Seybold, a physician group based in Houston that includes cancer and women’s health centers, two ambulatory surgery centers, and a sleep center, was first announced in April, but few details have emerged since, the Star Tribunereported.
However, Optum, based in Eden Prairie, Minnesota, did provide a statement to MedPage Today about incorporating Kelsey-Seybold’s operations and staff into the Optum network.
From the rather quiet monkeypox front, STAT News raises a new concern.
A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world.
The work, which has not yet been peer-reviewed, found that two doses of the vaccine induced relatively low levels of neutralizing antibodies against the monkeypox virus, and those antibodies had poor neutralizing capacity.
The researchers noted the so-called correlates of protection — what is needed, in terms of immune system weaponry, to be protected against monkeypox — are not known. Still, the evidence of low levels of neutralizing antibodies raises questions about how much protection is generated by two doses of the vaccine, marketed as Jynneos in the U.S. and made by the Danish manufacturer Bavarian Nordic. * * *
The study also casts a shadow over the recent decision by the U.S. government and others to stretch vaccine supplies by giving people one-fifth of a regular dose — and to do so by intradermal (into the skin) rather than subcutaneous (under the skin) injection. Intradermal administration, which requires smaller doses to be protective, has been shown to be effective in other disease outbreaks with other types of vaccine.
From the opioid epidemic front, STAT News features an interview with Rahul Gupta, M.D., “the director of the White House Office of National Drug Control Policy and the first doctor to hold that position.”
Gupta’s selection as director of the White House Office of National Drug Control Policy, however, has ushered in a new era of federal drug policy. As the first doctor to hold the position, he says he will embrace new strategies, including harm reduction tactics, which aim to reduce drug users’ risk of overdose, death, and disease in lieu of a hardline, abstinence-only attitude.
Still, though, addiction treatment is dogged by stigma, underuse of existing medications, and ongoing debate about certain harm-reduction techniques. The debate came to a head last week in California, where Gov. Gavin Newsom vetoed a bill to allow supervised injection sites — essentially clinics where people can use illicit drugs under medical supervision so as to prevent overdose.
Gupta sat down with STAT this week to discuss the ongoing crisis and the Biden administration’s efforts to address it. While circumspect about Newsom’s decision, Gupta did take several positions that are far more aggressive than any of his predecessors: Calling out doctors for their role in poor treatment outcomes; arguing that the addiction medication buprenorphine is widely misunderstood; and advocating for contingency management, a new addiction intervention that offers rewards — often cash — in exchange for cessation of drug use.
From the public health front, the Food and Drug Administrations discusses “Using A Whole-Of-Governments Approach to Combating Illicit Health Products.” Among other steps, “the agency has partnered with the Organisation of Economic Co-Operation and Development (OECD) Task Force on Countering Illicit Trade, which has been studying the problem of illicit trade for 15 years.”
From the Rx coverage front, Endpoints News informs us
Last July, the cost-effectiveness drug watchdog ICER released a preliminary draft report that Vivus’ Qsymia was the most cost-effective option for weight loss. That decision has now been validated.
ICER made its final determination Wednesday [August 31] that Qsymia, the brand name for the appetite suppressant phentermine combined with anticonvulsant topiramate, was more cost-effective for weight loss than other competitors such as Novo Nordisk’s Saxenda (liraglutide) and Wegovy (semaglutide) or Currax Pharmaceuticals’ Contrave (bupropion/naltrexone). * * *
ICER reviewers also added that if Qsymia wasn’t performing well in certain patients, Contrave may be the next best cost-effective option. The reviewers noted in their report that there were a few limitations to analysis, including the full impact of the drugs in patients with chronic kidney diseases or conditions where weight loss may be beneficial.
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 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.”
The Food and Drug Administration on Wednesday [August 31] authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.
The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.
With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.
The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.
Here’s a link to the CDC’s 2021 U.S. life expectancy report which was released today.
Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday [September 1] to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant.
A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE , as well as Moderna Inc is expected to pave the way for a rollout next week.
Medpage Today offers background on tomorrow’s CDC Advisory Committee on Immunization Practices meeting.
ACIP will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.
While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.
That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.
David Leonhardt, writing in his Morning column for the New York Times, provides his latest Covid poll which finds all Americans trending toward placing Covid in the rear view mirror.
A growing number of very liberal Americans have decided that it’s time to treat Covid as an unpleasant but manageable part of life, much as many other Americans — as well as people in other countries — decided months ago.
While the FEHBlog was pleased with the Times poll results, he thinks that Forbes hits the nail on the head with its opinion piece on how America can bring down its Covid death rate which took 383 lives yesterday.
Tragically, the vast majority of Covid-19 deaths are now preventable – if all Americans were up to date with vaccines, and if high-risk individuals got treated promptly after testing positive. If all that were to happen, Covid deaths in the U.S. would be nearly zero, as White House Covid-19 Response Team Coordinator Dr. Ashish Jha told the U.S. Chamber of Commerce Foundation recently.
What can the nation do to make that happen? Put simply, we must embrace the notion that Covid-19 deaths are largely preventable, not inevitable. Instead of trying to put those deaths out of mind, we should focus on what we can do to stop them.
Why are 400 Americans still dying each day? For starters, 15 million seniors have not received their first booster, and only 33% of Americans over 50 and 40% over 65 have received their second booster. In addition, over 20% of adults have not completed their primary vaccination series.
The health impacts of that inaction are sizable. The CDC estimates that among those 50 and older, the unvaccinated had a 29-fold increased risk of dying from Covid-19 and vaccinated people with only one booster had a 4-fold increased risk compared to those with two or more booster doses.
Meanwhile, access to the oral antiviral medication Paxlovid – which reduces the rates at which high-risk people get severe cases of Covid-19 or die from it – is the most limited in zip codes in which people were highly vulnerable to the virus. Moreover, access to and awareness of Evushield – which reduces the risk that immunocompromised people will develop symptomatic Covid-19 for up to six months – remains limited.
To keep Covid-19 and its impact in public consciousness, local health officials should publicly recognize when citizens in their communities lose their lives to the virus. For the same reason, local print and broadcast media should provide coverage of community memorials to those who have died. That should inspire citizens within communities to help each other fully access and use the tools available to all Americans, whether vaccines or treatments.
Local faith organizations, businesses, and other community leaders who have the trust of the population should redouble their efforts reminding individuals that their actions with respect to Covid-19 testing, vaccination, and treatment can make a tangible difference for their community.
Health care professionals should use every office visit, even if unrelated to Covid-19, to remind patients about the need to stay up to date with their vaccinations and have a plan to access treatment if they test positive and are eligible for treatment. The medical community’s attention to preventing and managing chronic conditions such as obesity and diabetes is now even more vital given their detrimental impact on Covid-19 outcomes.
Amen to that. Honestly, while the FEHBlog falls into the senior category, he has been delaying his second booster in order to receive the bivalent vaccine (or the Novovax booster which hasn’t been approved yet). The FEHBlog plans to make an appointment for the bivalent vaccine next week.
Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to Dawn O’Connell, Assistant Secretary for Preparedness and Response at the HHS.
The announcement comes after the HHS hosted over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies in a planning meeting on Tuesday.
“While the federal government has been pleased to play this role, we have always known that we would not be in this business forever,” O’Connell said in a post on the ASPR site. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.”
Read that as health plans may have to pay for their members’ Covid vaccinations next year. Conceding that the FEHBlog is not a Hyde amendment expert, he does not understand why the Senate leadership did not ram through more Covid funding in the massive budget reconciliation act.
The Drug Enforcement Administration issued an advisory Tuesday about an “emerging trend” of “brightly-colored” fentanyl pills being used to lure children and young people. What is often called “rainbow fentanyl” has been seized by law enforcement agencies in 18 states just this month, the DEA said.
The drugs, made to look like candy, comes in several forms, including “pills, powder and blocks that resembles sidewalk chalk,” the DEA said.
“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement.
The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.
On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.
In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.
In U.S. healthcare business news, Healthcare Dive reports
Walgreens Boots Alliance has completed its majority stake acquisition in at-home care technology platform CareCentrix, the retail pharmacy giant announced Wednesday.
The $330 million investment gives Walgreens a 55% ownership of CareCentrix. Walgreens has the option to acquire the remaining equity in the future.
The investment, first announced in October, expands Walgreen’s reach in the health sector, especially in the areas of primary care, specialty pharmacy, post-acute and home care, the company said in a Wednesday release.
Employers, who provide health coverage to roughly half the U.S. population, are acutely aware of where health care’s current cost trajectory is headed. In a recent survey of executives at 300 of the country’s largest employers, nearly 90% said they believe the cost of providing health benefits will become unsustainable within five to 10 years.
Yet instead of finding new ways to manage costs and help sustain this critical lifeline for America’s workers, many health systems continue to increase the prices they charge commercial insurers. And they can because, in many cases, newly consolidated health systems are the only game in town.
Employers and private insurers pay, on average, 224% of what Medicare would have paid for the same service at the same facility, despite new data showing that hospitals require payments that represent just 127% of Medicare to cover their expenses.
In federal employee compensation news, Federal News Network reports
President Joe Biden has formally announced his plans to give civilian federal employees a pay raise next year, starting on Jan. 1, 2023.
The president is specifically recommending a 4.1% across-the-board pay raise for federal employees in 2023, with an additional 0.5% average locality pay adjustment — resulting in a 4.6% average pay increase.
Biden said his alternative pay plan would help federal pay stay competitive with what workers with critical skills could earn in the private sector.
From the Omicron and siblings front, Regulatory Focus reports
[Last week,] both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5.
“The FDA is working tirelessly to evaluate the submissions to ensure the data meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality so that these new boosters are available as soon as possible,” Califf tweeted on Thursday, noting that the agency would base its decision on “the totality of available evidence,” including clinical trial data from other bivalent mRNA vaccines, real-world evidence from current vaccines and non-clinical data on the two BA.4/5-containing vaccines.
Califf also said that the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) would not be convened to review the submissions. “FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June. VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input,” he wrote.
From the monkeypox front, the Wall Street Journal informs us
A person in Texas who was diagnosed with monkeypox and had a weak immune system has died, Texas state health officials said Tuesday, in what could be the first-known fatality from the virus in the U.S.
The Texas Department of State Health Services said this was the first death of a person diagnosed with monkeypox in Texas. Officials are investigating what role monkeypox played in the death. They said the patient, who was an adult and a resident of Harris County, Texas, was “severely immunocompromised” but didn’t offer additional details.
In a statement, Texas health commissioner Dr. John Hellerstedt said that “monkeypox is a serious disease, particularly for those with weakened immune systems.” He urged those who have been exposed or have symptoms to seek treatment.
Concerns over monkeypox vaccine supplies appear to be softening after federal public health agencies initially scrambled to acquire enough doses of the shot.
The Biden administration has been working to boost its supply of vaccines in recent weeks, and so far has made over 1 million vials available to jurisdictions, “which is nearly enough to reach the entire population that’s most at risk,” HHS Secretary Xavier Becerra said during a call with reporters Tuesday.
The HHS also announced on Monday that it will provide about $11 million to support the first U.S.-based productioneffort for manufacturing the Jynneos vaccine at a facility in Grand Rapids, Michigan.
The FDA authorized administering the Jynneos shot intradermally — a method that requires only one-fifth of the usual dose but is just as effective, according to the agency.
However, the vaccine’s developer, Bavarian Nordic, has raised concerns about the method, citing a lack of data and evidence related to its efficacy.
About 75% of jurisdictions that have received the vaccine are administering it intradermally now, Bob Fenton, the White House’s monkeypox response coordinator, said on Tuesday’s call.
From the public health front, CNN Health discloses
CDC Director Dr. Rochelle Walensky has tapped Mary Wakefield — an Obama administration veteran and former nurse — to helm a major revamp of the sprawling agency and its multibillion-dollar budget. Making the changes will require winning over wary career CDC scientists, combative members of Congress, and a general public that in many cases has stopped looking to the agency for guidance.
“If she can’t fix it, she’ll say, ‘It’s not fixable, here’s why, and here’s what needs to be done next,'” said Eileen Sullivan-Marx, dean of the New York University Rory Meyers College of Nursing, who’s known Wakefield professionally for decades.
Less than 20% of providers submitted claims using a type of payment code [ICD 10 Z codes] that could help identify and address health disparities that adversely affect patient outcomes, according to a new ICON Market Access report.
The results come amid a growing call for payors and pharmaceutical manufacturers to work together to better address racial and ethnic health inequalities, speakers said during the AMCP 2022 annual meeting.
Such health disparities exist in nearly all U.S. states, said Jessica Cherian, PharmD, RPh, the vice president of content and strategic services for ICON Market Access, citing a 2021 Commonwealth Report, In 2021, her company surveyed 32 payor executives for their perceptions regarding health disparities in racial and ethnic groups, with a targeted focus on medication access and utilization.
Payors typically review data from claims, case manager screenings and more, and use that information to match members to programs that meet their SDOH needs, such as access to care, housing or transportation help, Ms. Fleming said. Payors also track needs through Z codes: additional codes provided in the International Classification of Diseases, Tenth Revision to report nonmedical factors influencing health status. For example, code Z63 would indicate difficulty with a patient’s family/support, such as alcoholism or drug addiction. Approximately 71% of payors in the ICON report used Z codes to monitor SDOH; however, they said less than 20% of submitted claims included these codes.
In payor personnel news, Healthcare Dive informs us
Name: David Brailer
New title: Executive vice president and chief health officer, Cigna
Brailer will assume his new role in early September, and will be Cigna’s first chief health officer.
In his role, he will focus on bringing together Cigna products, technologies and services in new ways in an attempt to drive more value and help improve overall health, according to the release.
He will report to Cigna Chairman and CEO David Cordani and will serve on the company’s enterprise leadership team.
From the healthcare costs front, the HHS Agency for Healthcare Quality and Research released “STATISTICAL BRIEF #543: Trends in Health Insurance at Private Employers, 2008-2021.”
“Highlights
“Employment-sponsored health insurance at private-sector employers was characterized by increases in premiums and cost-sharing for covered workers in 2021.
In 2021, average health insurance premiums were $7,380 for single coverage, $14,634 for employee-plus-one coverage, and $21,381 for family coverage, representing increases of 3.2, 3.1 and 3.0 percent, respectively, from their 2020 levels.
In 2021, the average employee contribution was $1,643 for single coverage, a 7.2 percent increase from the 2020 level. Single premium contributions increased at small (12.3 percent), medium (14.1 percent), and large firms (5.6 percent).
From 2020 to 2021, average deductible levels for single coverage increased by 3.0 percent to $2,004, and family coverage deductibles increased 3.9 percent to $3,868.
“From 2020 to 2021, there were no statistically significant changes in enrollment rates or offer rates for small, medium, or large firms.
“Overall enrollment and offer rates decreased from 2020 to 2021. These decreases are due to an increase in employment among small employers, and a corresponding decrease in the proportion of employees in medium and large firms, which have higher rates for both measures.
“In 2021, overall eligibility and take-up rates were not significantly different from 2020 levels.”
Cholesterol-lowering statins are proven lifesavers, but they’ve also gained a reputation for causing muscle aches and pains in a good number of patients.
That reputation is undeserved, according to a new large-scale analysis of data from nearly two dozen clinical trials of statins.
There’s a less than 10% chance that muscle symptoms reported by patients are caused by the statin they are taking, researchers report.
“Our analysis showed that over 90% of muscle symptoms were not attributable to the statin, and those cases that were due to statins occurred mainly within the first year of treatment,” said joint lead researcher Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, in England.
Statins have simply gotten a bad rap when it comes to muscle side effects, Baigent said.
In government contract reporting news, the Society for Human Resource Management reports
The Office of Federal Contract Compliance Programs (OFCCP) has issued a revised directive on compensation compliance, addressing concerns federal contractors had about a previous directive issued earlier this year. Some contractors were concerned that the prior version of the directive intruded upon communications protected by attorney-client privilege.
On the same day the revised directive was issued, OFCCP Director Jenny Yang wrote in a blog post that a top priority for the OFCCP is combating agency pay discrimination.
“Contractors therefore should review the directive and ensure they are engaging in compensation analyses as required by the regulations and be prepared to respond to questions regarding those analyses that are detailed in the directive,” said Guy Brenner, an attorney with Proskauer in Washington, D.C.
“Federal regulations require contractors periodically—or OFCCP interprets now as annually—[to] review their compensation systems to determine whether there are gender, race or ethnicity-based disparities in compensation,” said Sheila Willis, an attorney with Fisher Phillips in Columbia, S.C.
Yesterday, the FEHBlog discussed a U.S. Court of Appeals for the 11th Circuit opinion issued last Friday narrowing the scope of a nationwide injunction that a federal district court had imposed on the Biden Administration’s federal government contractor mandate.
The executive order is still enjoined in Alabama, Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Utah, West Virginia and Wyoming as a result of the Friday opinion and the injunctions in the other cases, members of the law firm McGuireWoods noted in a post.
A spokesperson for the Office of Management and Budget told Government Executive on Monday morning the Justice Department is currently reviewing the decision. “At this time, the nationwide injunction remains in effect, and thus agencies should continue not to take any steps to enforce Executive Order 14042.”
The nationwide injunction remains in effect at least until the appellate court issues its mandate to the lower court which typically happens in two weeks.
Also from the Omicron and siblings front, the Wall Street Journal discusses best practices for Covid testing while NPR tells us
The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding.
“Ordering through this program will be suspended on Friday, September 2 because Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” the ordering website says.
However, the program is still accepting orders before [next Saturday] Sep. 2.
From the No Surprises Act front, Mercer Consulting announced
A new prescription drug reporting mandate, adopted as part of the 2021 Consolidated Appropriations Act (CAA) (Pub. L. No. 116-260), requires group health plans and health insurers to report detailed data about prescription drug pricing (including rebates) and healthcare spending. The first reports are due by Dec. 27, 2022, and annually thereafter. The departments of Labor, Treasury, and Health and Human Services will use the information to prepare a biannual, publicly available report. The departments have issued interim final rules (IFR) detailing the data to report and recently updated submission instructions describing the mechanics of the reporting process. The updated instructions provide important information about reporting wellness services, prescription drug expenses that are covered by the pharmacy benefit manager and more.
Download the 21-page print-friendly article for details on the prescription drug reporting rules and the compliance challenges facing group health plans. This GRIST has been updated to reflect the updated submission instructions.
OPM added FEHB plans to the list of reporting plans and insurers. The initial report on the 2020 plan year is due no later than December 27, 2022.
From the FEHB plan design front, Federal News Network reports
Democratic lawmakers are urging the Office of Personnel Management to follow through on its plans to expand federal employees’ medical coverage to cover infertility diagnoses and treatments.
Sen. Tammy Duckworth (D-Ill.) and Government Operations Subcommittee Chairman Gerry Connolly (D-Va.) urged OPM on Monday to ensure all Federal Employee Health Benefits (FEHB) program carriers provide coverage for assistive reproductive technology (ART), which includes in vitro fertilization (IVF), starting in 2023.
The legislators’ demand strikes the FEHBlog as a day late and a dollar short because FEHB carriers and OPM closed their benefit and rate negotiations earlier this month. OPM did ask carriers in the agency’s 2023 call letter to plan on expanding ART coverage or offering a discounted ART network, among other options.
From the maternal health front, the Department of Health and Human Services announced “investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis – PDF. Funding aims to help reduce disparities in maternal and birth outcomes, expand and diversify the workforce caring for pregnant and postpartum individuals, increase access to obstetrics care in rural communities, and support states in tackling inequities in maternal and infant health.”
From the mental healthcare front, Health Payer Intelligence delves into the resources that AHIP has made available.
Seven strategic themes emerged from the list of ways that payers have helped members manage their mental health needs:
* Helping members find the right providers
* Creating opportunities for care through telehealth, online platforms
* Designing new payment models
* Expanding and educating the mental healthcare workforce
* Offering population-based services
* Supporting caregivers
* Expanding research and awareness
The article expounds on each of these themes.
From the U.S. healthcare business front, Fierce Healthcare reports
Months of inching performance gains were upended in July as the nation’s hospitals logged “some of the worst margins since the beginning of the COVID-19 pandemic,” Kaufman Hall wrote in its latest industry report. * * *
What’s more, seven straight months of negative margins “reversed any gains hospitals saw this year” and has the advisory group forecasting a brutal year for the industry.
“July was a disappointing month for hospitals and put 2022 on pace to be the worst financial year hospitals have experienced in a long time,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a statement. “Over the past few years, hospitals and health systems have been able to offset some financial hardship with federal support, but those funding sources have dried up, and hospitals’ bottom lines remain in the red.” * * *
The silver lining in Kaufman Hall’s report were total expenses that, although up 7.6% from July 2021, saw a modest 0.4% decline since June. Those savings came squarely among supply and drug expenses as total labor costs and labor expense per adjusted discharge still grew 0.8% and 3.5%, respectively, since June. Increases in full-time employees per adjusted occupied bed “possibly” suggest increased hiring, the group wrote in the report.
From the electronic health record interoperability front, Becker’s Health IT informs us
Judy Faulkner, CEO of Epic, discussed the company’s vision to build a nationwide health IT infrastructure last week at the annual Users Group Meeting while dressed as Amelia Earhart, according to The Cap Times.
Ms. Faulkner has a history of dressing as characters and historical figures for her highly anticipated keynote address at the meeting every year, and this year she chose Ms. Earhart, the iconic female pilot, as a nod to the meeting’s theme: A Night at the Museum. She talked about new technologies and expectations for Epic and its data platform, Cosmos. * * *
“We are building a nationwide health IT infrastructure to connect the different parts of healthcare,” Ms. Faulkner told the crowd.
Epic’s largest competitor in the hospital market, Oracle Cerner, is also on a mission to digitally connect the U.S. healthcare system. Larry Ellison, chair, co-founder and chief technology officer of Oracle, revealed in June the company’s plans to build a unified national healthcare database after acquiring Cerner earlier this year for $28.4 billion. His vision of a national healthcare database includes anonymized data from hospitals, clinics and providers to give real-time information about patients’ health as well as public health statistics.
Congress’s State / District work break ends next Monday Labor Day.
From the Omicron and siblings front, Federal News Network tells us that last Friday the U.S. Court of Appeals for the Eleventh Circuit, which is based in Atlanta, issued a ruling on the federal government’s appeal of a district court preliminary injunction of the Biden Administration’s Covid vaccination mandate on federal government contractors.
The three-judge panel’s majority found that a narrower injunction to block the mandate would have been warranted, and that once the case is fully litigated, the plaintiffs are at least “reasonably” likely to win their claim that the president can’t use his authority under procurement law to mandate vaccines for contractors.
But the court found Georgia District Court Judge Stan Baker went too far by applying the injunction nationwide during the case’s earliest stages last December. Instead, the court ruled, the injunction can only apply to the handful of parties who actually sued. * * *
In this case, that means the government is barred from enforcing the mandate against members of the Associated Builders and Contractors (ABC), and state agencies from seven states that were part of the same suit: Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. * * *
The administration completely suspended enforcement of the contractor mandate right after Judge Baker’s decision last December, and hasn’t yet said how it will respond to the new ruling partially lifting his injunction. A spokesman for the Office of Management and Budget did not immediately respond to an inquiry Friday evening.
From the healthcare cost front, Fierce Healthcare informs us
Healthcare price increases during the past year pale in comparison to those seen across the rest of the economy, suggesting that the healthcare sector has so far been spared from the full impact of 2022’s rapid inflation.
Healthcare’s upward price movement has so far been led by hospitals and nursing homes as opposed to other medical care spend, per an analysis of Bureau of Labor Statistics data released Wednesday.
Policy analysts affiliated with the Kaiser Family Foundation and the Peterson Center on Healthcare wrote that those quicker increases are likely a reflection of staff shortages and rising average wages and are likely to continue “unless hospitals can find ways to operate with fewer staff.”
With health prices often set in advance by the Centers for Medicare & Medicaid Services or private insurance contracting, however, the analysts wrote that “the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.”
In post-Dobb’s news, the Department of Health and Human Services brings us up to date on the steps that the Biden Administration has taken to protect access to abortion services. Most recently,
Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. The letter also underscored that current or proposed abortion restriction laws do not negate providers’ responsibilities to comply with federal laws protecting access to emergency health care. Also today, HHS issued a report and plan of action in response to the Dobbs v. Jackson Women’s Health Organization Supreme Court decision.
From the mental healthcare front, NPR brings us inside the operations of 988 call centers in Pennsylvania.
The 2020 law enacting the 988 number also allows states to pass legislation to add a small fee to cell phone bills as a permanent source of funds for 988 and associated mental health services. So far, only four states have done so, and only two more have proposed legislation.
Pennsylvania is not one of those states, and doesn’t have any other funding plan implemented. That worries Kevin Boozel, who heads the County Commissioners Association of Pennsylvania.
“This is life or death,” Boozel says. “And you can’t halfway do it.”
He pointed out that Pennsylvania has decided to hold back on publicizing the new 988 number until next year. The fear is that too many calls could flood the system, and counties need more time to set up funding, hire workers and build capacity for things like those mobile crisis teams.
Challenges aside, In Centre County, Herr McCann emphasizes that calling the hotline works. In most cases, just talking with someone is enough to defuse a crisis.
“When they have someone who is empathetic and who listens, that connection helps them,” she said. That lets people know that “it isn’t hopeless. There is hope out there. There is help out there.”
From the health benefit plan design front, Fierce Healthcare reports
Bicycle Health, a virtual provider for opioid use disorder treatment, has announced it is now part of Cigna Evernorth’s behavioral health network.
The startup’s services will now be available to all Evernorth and Cigna health plan customers in the 24 states where Bicycle Health operates. The potential reach is millions of patients, the company told Fierce Healthcare without disclosing additional details.
More than 200 post offices and other U.S. Postal Service facilities are set to shed some of their operations as soon as this year as the mailing agency seeks to consolidate those functions at larger buildings, according to documents shared by management.
The changes will mean letter carriers no longer go to their local facility to pick up mail for their route, instead traveling farther distances after starting at a consolidated location. The impacted post offices will still conduct their retail operations, but many of the back-end functions will be stripped away and relocated. They are connected to an initial 10 buildings that USPS previously announced it was standing up in previously closed facilities, as well as an additional 11 centers.
Most post offices around the country operate as delivery units, meaning mail carriers go to them to pick up mail and packages for their routes before bringing them to homes and businesses. Postmaster General Louis DeJoy has repeatedly decried this model, saying it is inefficient and can lead to as many as dozens of such units in one metropolitan area. Instead, he is looking to open “sorting and delivery centers” around the country, as well as larger mega-centers, that can take on more work in less space. Letter carriers will have to travel farther to take mail to its final destination, but DeJoy said it will save costs on the contracted trucks that USPS hires to bring mail between various facilities.
The impactedsites are located in Georgia, New York, Texas, Florida, Michigan, Pennsylvania, Ohio, Kansas, Maryland, Massachusetts, West Virginia, Kentucky, Washington, North Carolina, Indiana and Arkansas. The initial consolidations are expected to begin as soon as next month.
From the omicron and siblings front, MedPage Today provides us with good news.
Older patients treated with nirmatrelvir boosted by ritonavir (Paxlovid) for COVID-19 had lower rates of hospitalization and death compared with those not treated with the antiviral during the Omicron wave, according to an observational retrospective cohort study from Israel.
Among patients ages 65 and older, the rate of hospitalization due to COVID was 14.7 cases per 100,000 person-days for the 2,484 patients who received nirmatrelvir compared with 58.9 cases per 100,000 person-days for the 40,337 untreated patients (adjusted HR 0.27, 95% CI 0.15-0.49), reported Ronen Arbel, PhD, of Clalit Health Services in Tel Aviv, and colleagues.
Death occurred in two nirmatrelvir-treated patients and in 158 untreated patients (aHR 0.21, 95% CI 0.05-0.82), they said in the New England Journal of Medicine.
Herd safety, indeed.
From the Rx research and development front, NBC News reports
Two doses of psilocybin pills, along with psychotherapy, helped people with alcohol use disorder reduce drinking for at least eight months after their first treatments, results from the largest clinical trial of its kind show.
During the eight-month trial, 93 men and women ages 25 to 65 were chosen to receive either two psilocybin doses or antihistamine pills, which the researchers used as a placebo. They all also participated in 12 psychotherapy sessions.
All of the volunteers were averaging seven alcoholic drinks at a time before the trial.
More than 80% of those who were given the psychedelic treatment had drastically reduced their drinking eight months after the study started, compared to just over 50% in the antihistamine control group, according to results published Wednesday in JAMA Psychiatry. At the end of the trial, half of those who received psilocybin had quit drinking altogether, compared to about one-quarter of those who were given the antihistamine.
A vaccine Pfizer is developing protected older adults against the respiratory syncytial virus, or RSV, which is a common cause of hospitalization and death in the U.S., the company said Thursday.
The experimental vaccine, known as RSVpreF, is considered a key product in Pfizer’s pipeline of experimental drugs. Right now drug companies are close to launching several different products against RSV, focused on protecting both older adults and infants.
BioMarin, a California-based biotechnology company, said Wednesday that its gene therapy for hemophilia has been cleared for market by European regulators, marking a first-of-its-kind approval.
The therapy, known as Roctavian, was given conditional marketing authorization as a treatment for certain patients with hemophilia A, the more common version of the rare bleeding disorder. Specifically, Roctavian is to be used in adults with “severe” disease — hallmarked by exceedingly low levels of a blood-clotting protein called Factor VIII — who don’t have a history of developing antibodies that attack this protein.
With approval in hand, BioMarin is now working to secure reimbursement across the European Commission’s various member states. Jeff Ajer, the company’s chief commercial officer, said on a conference call Thursday that the plan is to immediately launch Roctavian in Germany, followed by France. The company expects Roctavian’s list price in Europe to be “around” 1.5 million euros, or roughly $1.5 million, net of all discounts, he said.
Ajer added that BioMarin expects to disclose the specific European list price in October, a number that will be in-line but lower than the comparable net price in the U.S.
Employers view long-term mental health as the key healthcare issue coming out of COVID-19, according to a new survey.
Nearly half (44%) of employers surveyed by the Business Group on Health said they have seen this trend in their workforces, and another 44% expect to see worsening mental health in the future. Most (85%) said they anticipate enhanced mental health benefits launched under the pandemic to continue.
Mental health conditions also ranked sixth on the survey’s list of conditions driving healthcare costs, with 17% of those surveyed saying it was a major driver. This is a marked increase from 9% in 2020 and 14% in 2021.
Brenna Shebel, vice president of the Business Group on Health, said during a briefing with reports Tuesday that many employers are tackling mental health challenges “at all different angles.”
AHIP, which stands for America’s Health Insurance Plans, issued a statement and “advocacy vision” at a time its member health plans are looking beyond paying and coordinating just medical care but also integrating behavioral health care into benefit plans for their government, commercial and employer clients. * * * Further details of the policy proposals and commitments can be found here.
From the U.S. healthcare business front, we learn about financial results for two health systems involved with the FEHB Program.
Becker’s Hospital Review reports that ” Intermountain Healthcare [based in Utah and serves surrounding states] saw its revenues increase in the first half of this year, and its merger with SCL Health fueled a significant increase in net income, according to recently released financial documents. The financial documents are the first Intermountain has filed since completing a merger with Broomfield, Colo.-based SCL Health in April.
Beckers Hospital CFO Report tells us, “UPMC reported higher revenue in the first half of this year than in the same period of 2021, but the Pittsburgh-based health system’s operating income declined year over year, according to financial documents released Aug. 23. * * * “Throughout 2022, the continued effect of COVID-19, along with conditions in the labor and supply markets have resulted in cost growth in employment, staffing and other operating expenses in excess of revenue growth,” UPMC management wrote in the financial filing.”
Finally STAT News delves into why so many large healthcare companies are interested in Signify Health. Quite simply,
The bidding war over Signify Health — a health technology business that could fetch multibillion-dollar offers from Amazon, CVS, and UnitedHealth Group — is not about its dazzling software or a blockbuster AI algorithm.
The crush of corporate interest, experts said, stems from something much bigger: the opportunity to move medical services back into the home. In-home care is quickly becoming the biggest battlefield in America’s biggest business, with a huge array of companies seeking to move health care outside the institutional walls that have confined it for much of the last century.
Signify Health is among those at the forefront of the quest. The Texas-based company, founded in 2017 as the result of a merger, has built its business around delivering highly detailed assessments of patients by visiting with them in their bedrooms and living rooms, creating better visibility — and clearer data — about their lives and health status.
The biotech’s reformulated shot targets both the original coronavirus strain and the BA.4/BA.5 omicron subvariants. BA.5 now accounts for almost 90% of cases in the U.S., with versions of BA.4 making up almost all of the rest, according to estimates from the Centers for Disease Control and Prevention.
Moderna and Pfizer have been working closely with the FDA to design boosters that can better fend off COVID-19, particularly as immunity wanes in people who were last vaccinated many months ago. On Monday, Pfizer announced it had finished its application. Moderna followed a day later.
The Wall Street Journal discusses monkeypox’s symptoms, vaccines and how it spreads:
[I]nfectious-disease experts say patterns of transmission in this outbreak have been consistent with the need for close contact, rather than airborne spread. If the virus could easily spread through airborne transmission, they say many more cases outside the LGBT community would be expected. * * *
Most monkeypox cases in the U.S. have been mild, though some patients have experienced moderate to severe disease with symptoms such as extreme pain and high fevers and have had to be hospitalized. * * *
Most monkeypox cases in the U.S. and globally have, to date, been among men who have sex with men. The CDC released data finding the outbreak is concentrated among men who have had sex with several men. Public-health experts say the current risk to the general population is low.
“At this moment in terms of acquiring monkeypox, I wouldn’t change my behavior,” said Dr. Chin-Hong, noting that the calculation would be markedly different for someone in an at-risk group.
Though a handful of children in the U.S. have contracted monkeypox, infectious-disease experts say the risk to most children is very low.
In other public health news
Becker’s Payer Issues tells us “Cancer has overtaken musculoskeletal conditions as large employers’ biggest driver of healthcare costs, according to Business Group on Health’s ‘2023 Large Employers’ Health Care Strategy and Plan Design Survey.’ Business Group on Health surveyed 135 employers across various sectors that together cover more than 18 million people between May 31 and July 13, according to the August 23 report.”
Becker’s Hospital Review ranks the states by average life expectancy.
In judicial news —
The FEHBlog checked the court docket in the Change Healthcare antitrust case today, and he discovered that the defense rested in the bench trial on August 15, and the Court has scheduled closing arguments for September 8. The bench trial, in this case, pending in the U.S. District Court for the District of Columbia, began on August 1.
A federal judge blocked Idaho from enforcing its near-total abortion ban in certain emergency situations, an early victory for the Justice Department in a case it filed this month.
U.S. District Judge B. Lynn Winmill on Wednesday issued a preliminary injunction that prevents the state from enforcing its ban in emergency circumstances where doctors and hospitals deem an abortion is necessary to avoid placing the health of a pregnant patient in serious jeopardy. * * *
In that case, a federal judge in Lubbock ruled that hospitals and doctors for now aren’t required to abide by the administration’s guidance requiring emergency abortion care.
The next stop is the federal appellate courts in both cases.
Three years after it began piloting a primary care service for its employees that blended telehealth and in-person medical services, Amazon plans to cease operations of its Amazon Care service.
Amazon announced Wednesday afternoon that it would end Amazon Care operations after December 31. In an email to Amazon Health Services employees, Neil Lindsay, senior vice president of Amazon Health Services, said Amazon Care wasn’t a sustainable, long-term solution for its enterprise customers.
Amazon provided a copy of the email to Fierce Healthcare.
The decision only impacts Amazon Care and Care Medical teams and not Amazon’s other healthcare services.
If the One Medical deal goes through, it would significantly expand Amazon’s foothold in the nearly $4 trillion healthcare market, specifically in the competitive primary care market.
One Medical markets itself as a membership-based, tech-integrated, consumer-focused primary care platform. The company operates 188 offices in 29 markets. At the end of March, One Medical had 767,000 members.
The deal also gives Amazon rapid access to the lucrative employer market as One Medical works with 8,000 companies.
This news suggests to the FEHBlog that Amazon is confident that the One Medical acquisition will close.
Kaiser Health News offers an enlightening story on unregulated dietary supplements.
Dietary supplements, which include a broad range of vitamins, herbs, and minerals, are regulated by the FDA. However, they are classified as food and don’t undergo the rigorous scientific and safety testing the government requires of prescription drugs and over-the-counter medicines.
Lawmakers aren’t proposing to put supplements into the same category as pharmaceuticals, but some say they are alarmed that neither the FDA nor the industry knows how many dietary supplements are out there — making it almost impossible for the government to oversee them and punish bad actors.
The FDA estimates 40,000 to 80,000 supplement products are on the market in the U.S., and industry surveys estimate 80% of Americans use them.
From the Omicron and siblings front, the Wall Street Journal reports
The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.
The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.
Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots.
Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.
Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.
From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.
Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.
From the medical research front, BioPharma Dive reports
Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.
At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.
If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.
The article provides an overview of these RNA drug development efforts.
From the tidbits department —
MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
