COVID-19 vaccine Archives - Page 12 of 44

Midweek update

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–August 31, 2022October 10, 2022

From the Omicron and siblings front —

The New York Times reports

The Food and Drug Administration on Wednesday [August 31] authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.
The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.
With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.
The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.

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

Reuters adds

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday [September 1] to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant.
A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE , as well as Moderna Inc is expected to pave the way for a rollout next week.

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

ACIP will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.
While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.
That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.

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

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

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

Tragically, the vast majority of Covid-19 deaths are now preventable – if all Americans were up to date with vaccines, and if high-risk individuals got treated promptly after testing positive. If all that were to happen, Covid deaths in the U.S. would be nearly zero, as White House Covid-19 Response Team Coordinator Dr. Ashish Jha told the U.S. Chamber of Commerce Foundation recently.
What can the nation do to make that happen? Put simply, we must embrace the notion that Covid-19 deaths are largely preventable, not inevitable. Instead of trying to put those deaths out of mind, we should focus on what we can do to stop them.
Why are 400 Americans still dying each day? For starters, 15 million seniors have not received their first booster, and only 33% of Americans over 50 and 40% over 65 have received their second booster. In addition, over 20% of adults have not completed their primary vaccination series.
The health impacts of that inaction are sizable. The CDC estimates that among those 50 and older, the unvaccinated had a 29-fold increased risk of dying from Covid-19 and vaccinated people with only one booster had a 4-fold increased risk compared to those with two or more booster doses.
Meanwhile, access to the oral antiviral medication Paxlovid – which reduces the rates at which high-risk people get severe cases of Covid-19 or die from it – is the most limited in zip codes in which people were highly vulnerable to the virus. Moreover, access to and awareness of Evushield – which reduces the risk that immunocompromised people will develop symptomatic Covid-19 for up to six months – remains limited.
To keep Covid-19 and its impact in public consciousness, local health officials should publicly recognize when citizens in their communities lose their lives to the virus. For the same reason, local print and broadcast media should provide coverage of community memorials to those who have died. That should inspire citizens within communities to help each other fully access and use the tools available to all Americans, whether vaccines or treatments.
Local faith organizations, businesses, and other community leaders who have the trust of the population should redouble their efforts reminding individuals that their actions with respect to Covid-19 testing, vaccination, and treatment can make a tangible difference for their community.
Health care professionals should use every office visit, even if unrelated to Covid-19, to remind patients about the need to stay up to date with their vaccinations and have a plan to access treatment if they test positive and are eligible for treatment. The medical community’s attention to preventing and managing chronic conditions such as obesity and diabetes is now even more vital given their detrimental impact on Covid-19 outcomes.

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

Finally, Healthcare Dive informs us

Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to Dawn O’Connell, Assistant Secretary for Preparedness and Response at the HHS.
The announcement comes after the HHS hosted over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies in a planning meeting on Tuesday.
“While the federal government has been pleased to play this role, we have always known that we would not be in this business forever,” O’Connell said in a post on the ASPR site. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.”

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

Moving onto the country’s fentanyl crisis

CBS News tells us

The Drug Enforcement Administration issued an advisory Tuesday about an “emerging trend” of “brightly-colored” fentanyl pills being used to lure children and young people. What is often called “rainbow fentanyl” has been seized by law enforcement agencies in 18 states just this month, the DEA said.
The drugs, made to look like candy, comes in several forms, including “pills, powder and blocks that resembles sidewalk chalk,” the DEA said.
“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement.

Regulatory Focus adds

The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.

On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.

In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.

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

Walgreens Boots Alliance has completed its majority stake acquisition in at-home care technology platform CareCentrix, the retail pharmacy giant announced Wednesday.
The $330 million investment gives Walgreens a 55% ownership of CareCentrix. Walgreens has the option to acquire the remaining equity in the future.
The investment, first announced in October, expands Walgreen’s reach in the health sector, especially in the areas of primary care, specialty pharmacy, post-acute and home care, the company said in a Wednesday release.

STAT News observes

Employers, who provide health coverage to roughly half the U.S. population, are acutely aware of where health care’s current cost trajectory is headed. In a recent survey of executives at 300 of the country’s largest employers, nearly 90% said they believe the cost of providing health benefits will become unsustainable within five to 10 years.
Yet instead of finding new ways to manage costs and help sustain this critical lifeline for America’s workers, many health systems continue to increase the prices they charge commercial insurers. And they can because, in many cases, newly consolidated health systems are the only game in town.
Employers and private insurers pay, on average, 224% of what Medicare would have paid for the same service at the same facility, despite new data showing that hospitals require payments that represent just 127% of Medicare to cover their expenses.

In federal employee compensation news, Federal News Network reports

President Joe Biden has formally announced his plans to give civilian federal employees a pay raise next year, starting on Jan. 1, 2023.
Most civilian employees under the General Schedule, as anticipated, will receive an average 4.6% federal pay raise in 2023, according to the alternative pay plan Biden submitted to congressional leaders Wednesday afternoon.
The president is specifically recommending a 4.1% across-the-board pay raise for federal employees in 2023, with an additional 0.5% average locality pay adjustment — resulting in a 4.6% average pay increase.
Biden said his alternative pay plan would help federal pay stay competitive with what workers with critical skills could earn in the private sector.

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, COVID-19 vaccine, Government Contracting, Rx coverage, U.S. Healthcare–August 30, 2022October 10, 2022

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.

Healthcare Dive adds

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.

Also, Specialty Pharmacy Continuum points out

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.”

From the Rx coverage front, HealthDay tells us

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.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–August 8, 2022October 10, 2022

From Capitol Hill —

The Federal Times seeks to project the timeline for implementing the new law requiring the Veterans’ Administration to cover illnesses contracted by Iraq and Afghanistan veterans who were exposed to burn pit smoke while overseas.

The Republicans on the House Ways and Means Committee offer their perspective on the budget reconciliation bill that Senate passed yesterday and the House will take up this Friday.

From the OPM front, the FEHBlog noticed today that its Office of Inspector General (OIG) has posted on its revamped website the OIG’s semi-annual report to Congress for the period ended March 31, 2022. This report is always worth a gander to those who are interested in the FEHB Program.

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

Parents are having their say about the Covid-19 vaccines for children under 5, and for most, the answer so far is no.
More than a month after the U.S. Centers for Disease Control and Prevention recommended shots for about 17.4 million children ages 6 months through 4 years, about 4% to 5% of them have received a shot, according to the most recent agency data and population estimates from the American Academy of Pediatrics.
By contrast, the vaccination rate for children 5 to 11 years reached about 18% a month after the CDC first recommended shots last November. The rate now stands at about 38%. * * *
Uptake has varied by state, recent counts from around the U.S. show. In Massachusetts, roughly 40,541 children under 5, about 11% of the state’s population in that age group, have received one dose. In New Jersey, more than 21,000 young children, or 4.6% of the children under 5 in that state, have received one dose.

A lawyer writing on the Society for Human Resource Management advises “employers with workers who test positive for COVID-19 should follow guidance from the Centers for Disease Control and Prevention (CDC), including its guidelines on quarantining and isolation, to minimize safety and legal risks, even though the guidance is somewhat complex.”

From the public health front, the Department of Health and Human Services announced today its Health Resources and Services Administration (HRSA) is

awarding nearly $90 million in American Rescue Plan funding to nearly 1,400 community health centers across the country to advance health equity through better data collection and reporting. On Friday, August 5, President Biden issued a proclamation on National Health Center Week to recognize the vital role health centers play in safeguarding the well-being of Americans and honor the heroic staff who keep these facilities running.

What’s more, the American Hospital Association tells us

[HRSA] today awarded $45.7 million from the American Rescue Plan Act [ARPA]to develop the public health workforce in rural and tribal communities. The grants will help train dental hygienists, medical and dental assistants, doulas and other community health workers; health information technology and telehealth technical support staff; community paramedical workers; and respiratory therapists and care coordinators for patients with long-term COVID-19 effects and chronic medical conditions.
In addition to the ARPA grants, the agency awarded $9.7 million to help hospitals and others establish new medical residency programs in rural communities; $2.9 million to improve health outcomes in rural counties; and nearly $1 million to improve access to care for rural veterans.

From the No Surprises Act front, Healthcare Dive informs us

The Medical Group Management Association, which represents physician practices, is urging the HHS and the CMS to delay enforcing certain requirements of the No Surprises Act to allow providers time to understand and implement the mandates.
In a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks La-Sure, MGMA asked that medical group practices be given six months’ notice before enforcement of additional surprise billing requirements.
The provider group requested the enforcement delay following publication of more anticipated rulemaking including an advanced explanation of benefits, continuity of care protections and provider directory requirements.

The FEHBlog supports the MGMA’s position because Congress goofed in the NSA by not treating the good faith estimate and advance EOB as HIPAA electronic transaction standards.

STAT News discusses the stress that providers and payers are experiencing as they wait for the Labor Department to issue its final rule (following receipt of public comments on its interim final rule) about the NSA’s independent dispute resolution process.

From the Rx coverage front, STAT News reports

Karuna Therapeutics said Monday that a novel combination pill reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial.
With positive study results in hand, the Boston-based biotech intends to submit a marketing application with the Food and Drug Administration by the middle of next year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.
Called KarXT, the Karuna drug targets muscarinic acetylcholine receptors in the brain to reduce psychotic symptoms. Current antipsychotics — which mostly block dopamine receptors — have become blockbuster schizophrenia medicines despite causing troubling side effects like weight gain and somnolence. Peak sales for KarXT could also reach into the billions of dollars, analysts forecast.

That’s certainly encouraging.

From the U.S. healthcare business front —

Fierce Healthcare reports

Kaiser Permanente posted a thinned operating margin and nearly $1.3 billion net loss during its second quarter “driven largely by investment market conditions,” according to topline financials for the quarter ended June 30 reported Friday evening.
The massive integrated nonprofit health system notched $23.47 billion in total operating revenues, representing a minor 0.9% dip from the second quarter of last year. Total operating expenses inched nearly 0.2% upward year over year, to $23.38 billion.
The result was an operating income of $89 million (0.4% operating margin) during the most recent quarter, down from the prior year’s $349 million (1.5% operating margin).
“Much like the entire health care industry, we continue to address deferred care while navigating COVID-19 surges and associated expenses. Kaiser Permanente’s integrated model of providing both care and coverage enables us to meet these challenges as demonstrated by our moderate increase in year-over-year operating expenses for the second quarter,” EVP and Chief Financial Officer Kathy Lancaster said in a statement accompanying the filing.

BioPharma Dive informs us

Pfizer on Monday said it has agreed to acquire Global Blood Therapeutics for $5.4 billion in a deal that will hand it a recently approved drug for sickle cell disease, as well as two other experimental medicines for the rare blood condition. Under terms of the deal, Pfizer will pay $68.50 in cash per Global Blood share * * *. * * * Pfizer and Global Blood expect the deal, which has been approved by the boards of directors at both companies, to close as early as the fourth quarter, pending the sign off regulators and Global Blood shareholders.

Becker’s Hospital Review is running a series on health information interoperability:

Health data interoperability has long been a goal of health IT executives and policy experts. But it’s 2022 — and the healthcare system doesn’t appear all that close to getting there.
Becker’s spoke to experts from health systems, industry and academia on what it will take to create an open exchange of healthcare information in the U.S.
The first entry in the series is a Q&A with Donna Roach, CIO of University of Utah Health in Salt Lake City

Check it out.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, OPM, Telehealth, U.S. Healthcare, Uncategorized–July 28, 2022October 10, 2022

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity. * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.
But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.
“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.
Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Telehealth, U.S. Healthcare–July 27, 2022October 10, 2022

From Capitol Hill —

The Wall Street Journal reports

Sen. Joe Manchin (D., W.Va.) agreed to back a package aimed at lowering carbon emissions and curbing healthcare costs while raising corporate taxes, marking a stunning revival of core pieces of President Biden’s economic and climate agenda that the West Virginia Democrat had seemingly killed earlier this month.
The deal, negotiated privately between Messrs. Manchin and Senate Majority Leader Chuck Schumer (D., N.Y.) since the start of last week, would raise roughly $739 billion, with much of the revenue coming from a 15% corporate minimum tax and enhanced tax enforcement efforts at the Internal Revenue Service, as well as projected savings from allowing Medicare to negotiate some prescription-drug prices.
Of that new revenue, roughly $369 billion would be spent on climate and energy programs, with another $64 billion dedicated to extending healthcare subsidies for three years for some Affordable Care Act users. The bill would dedicate the rest of the new revenue toward reducing the deficit, according to a summary provided by Messrs. Schumer and Manchin. * * *
The deal will still need the support of almost every other Democrat in Congress. Passing the agreement into law will test Mr. Schumer and the ability of House Speaker Nancy Pelosi (D., Calif.) to convince an ideologically diverse group of lawmakers to accept a deal announced by one of the party’s most conservative members.
The announcement of a deal on Wednesday appeared to catch other Democrats off guard.

The Hill informs us

The House passed a bill Wednesday to expand telehealth services that were first introduced during the COVID-19 pandemic.
The legislation, titled the Advancing Telehealth Beyond COVID–19 Act, passed in a 416-12 vote. Eleven Republicans and one Democrat objected to the measure. Two Republicans did not vote.
The measure seeks to continue a number of telehealth policies established under Medicare that were first implemented at the beginning of the COVID-19 pandemic. If passed by the Senate and signed into law, the provisions would continue through 2024.

Fierce Healthcare adds

A key House panel advanced legislation to create an electronic prior authorization process for Medicare Advantage plans and several other reforms.
The House Ways and Means Committee unanimously advanced on Wednesday the Improving Seniors Timely Access to Care Act of 2022. The legislation has more than 300 co-sponsors and wide support across the healthcare industry.

From the Omicron and siblings front, Medpage Today asks “Can I boost with Novovax?”

While the Novavax shot is not yet authorized by the FDA as a booster, several experts told MedPage Today it could be headed that way.
“Probably the best niche now for Novavax’s purified protein vaccine is as a booster strategy for mRNA vaccines,” Paul Offit, MD, of Children’s Hospital of Philadelphia, who served on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Novavax, told MedPage Today.
Robert “Chip” Schooley, MD, an infectious disease expert at the University of California San Diego who has served on VRBPAC in the past, said since there “aren’t many people left who have been neither vaccinated nor infected … it will likely be mainly used as a booster.”

NPR Shots tells us

The Biden administration may scrap plans to let more younger adults get second COVID-19 boosters this summer. Instead, officials are trying to speed up availability of the next generation of boosters in the fall, NPR has learned.
The new strategy is aimed at trying to balance protecting people this summer with keeping people safe next winter, when the country will probably get hit by yet another surge.
But the possible shift is being met with mixed reactions. The Food and Drug Administration could make a final decision by the end of the week.
The dilemma facing the FDA is that the immunity many people have gotten from getting vaccinated or infected has been wearing off. At the same time, the most contagious version of the virus to emerge yet — the omicron subvariant BA.5 — is making people even more vulnerable.
So as COVID is starting to become more serious than a cold or flu again, most people younger than age 50 aren’t eligible for fourth shots — second boosters — to protect themselves. In response, the FDA was considering opening up eligibility for second boosters for all adults.
But letting more people get boosted with the original vaccine now could interfere with plans to boost them with updated, hopefully more protective vaccines in the fall to blunt the toll of the winter surge.

It’s quite a conundrum for the experts.

From the monkeypox front

NPR provides a helpful FAQ on the disease.

Medscape adds

The Centers for Disease Control and Prevention (CDC) has expanded access to vaccines, tests, and treatments for monkeypox, agency officials said in a webinar Tuesday.
The CDC expects to release more than 750,000 doses of the JYNNEOS vaccine from its strategic stockpile within days, said panelists at the Clinician Outreach and Communication Activity (COCA) call.
In addition, by working with commercial labs, the agency has expanded US testing capacity and streamlined requirements for administering the antiviral tecovirimat, they said.

Encouraging news from the HIV front. The Wall Street Journal reports

A 66-year-old man in Southern California and a woman in her 70s in Spain are the latest in a small group of people who appear to have beaten their HIV infections, providing researchers new clues to a possible cure at a time when Covid-19and other crises are slowing progress against the spreading virus.
Doctors caring for the man said they haven’t found any human immunodeficiency virus that can replicate in his body since he stopped antiretroviral drug therapy in March 2021 after a transplant of stem cells containing a rare genetic mutation that blocks HIV infection. He was given the transplant for leukemia, for which people with HIV are at increased risk. Details of his case were made public Wednesday and will be presented at a large international AIDS conference in Montreal that opens Friday.
“He saw many of his friends and loved ones become ill and ultimately succumb to the disease and had experienced some stigma associated with having HIV,” she said. His success “opens up the opportunity potentially for older patients to undergo this procedure and go into remission from both their blood cancer and HIV.

Also from the medical research front, STAT News informs us

[F]or several years, a small New Haven, Conn.-based startup has quietly been building technology to move the needle on suicide rates among the people at highest risk: those with a history of attempts or who have suicidal thoughts and have expressed a strong desire to die.
The company, called Oui Therapeutics, has raised roughly $26 million from high-profile investors like CVS Health Ventures and First Round Capital to develop and launch an app designed to train people how to quell their suicidal impulses. It pulls from in-person therapy methods that have shown dramatic reductions in suicide attempts — nearly 60% — in a randomized trial of soldiers at high risk. * * *
If the research bears out and the app secures buy-in from regulators, it could become a powerful tool in curbing suicide, which kills over 45,000 people in the U.S. each year. Oui is part of a broader constellation of efforts — including a new national suicide prevention hotline number and the development of prevention frameworks like Zero Suicide — in recent years that aim to address rates that have risen stubbornly high.

Fingers crossed for both worthy efforts.

From the Medicare front, Beckers Hospital Review reports

CMS updated its Overall Hospital Quality Star Ratings for 2022, giving 429 hospitals a rating of five stars.
CMS assigned star ratings to hospitals nationwide based on their performance across five quality categories. This year:
* 192 hospitals received a one-star rating
* 692 hospitals received a two-star rating
* 890 hospitals received a three-star rating
* 890 received a four-star rating
* 429 received a five-star rating

The article lists all of the five star hospitals by state.

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

Humana raised its profit estimates for the full year after reporting lower than expected medical costs during the second quarter.
“The lower utilization trends and lack of COVID headwinds seen to date, give us confidence in raising our full year adjusted [earnings per share] guide,” Humana CFO Susan Diamond said Wednesday on a call with investors.
Humana’s net income increased 18% to $696 million for the second quarter as the Louisville-based insurer recorded increased revenues of $23.6 billion amid enrollment growth in both Medicare and Medicaid.
The insurer noted lower inpatient utilization among Medicare members for Q2.
But the lower-than-anticipated inpatient utilization has been partially offset by higher unit costs, Diamond said. * * *
The company’s total medical membership of 17.1 million was up 0.8% year over year.
As the company continues on its value creation plan to trim $1 billion in costs, Humana said it will restructure its organization into two distinct units as it looks to simplify the company’s overall organization.

Revcycle Intelligence reports on how healthcare spending varies by region and payer type.

There is substantial variation and low correlation in healthcare spending across Medicare, Medicaid, and private insurance plans within different US regions, a study published in JAMA Network Open found.
The US spends around $3.8 trillion per year on healthcare funded by Medicare, Medicaid, and private insurers. However, spending and healthcare utilization are rarely the same for all three payers. * * *
Healthcare spending per beneficiary varied across payers. The mean private insurance spending per beneficiary was $4,441, while the Medicare mean was $10,281, and the Medicaid mean was $6,127 per beneficiary. The overall mean for the three payers was $5,782 per beneficiary.
Medicaid had the most variation in spending per beneficiary across the [241 hospital referral regions] HRRs, with a coefficient of variation of 0.233, according to the study. Private insurance had a coefficient of variation of 0.160 and Medicare had a coefficient of variation of 0.126.
Medicaid and private insurance plans likely saw more variation in spending than Medicare because Medicare relies on regulated payments to hospitals, while Medicaid and privately insured prices are generally determined by the region’s market.
In addition to spending variation among the payers individually, there was low spending correlation within regions across all three payers.
For example, the correlation coefficient between HRR level spending was 0.020 for private insurance and Medicare, 0.213 for private insurance and Medicaid, and 0.162 for Medicare and Medicaid.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–July 20, 2022October 10, 2022

From Capitol Hill, Govexec reports

The House [of Representatives on Wednesday voted 220-207 to pass the first minibus fiscal 2023 spending package, effectively endorsing President Biden’s plan to increase federal employees’ pay by an average of 4.6% next year.
The minibus contains six of the 12 annual appropriations bills, including transportation, housing and urban development; agriculture and rural development; energy and water development; military construction and veterans affairs; and financial services and general government, the last of which serves as the vehicle for provisions impacting federal employee compensation[, including the FEHBP].

In other news from our Nation’s Capital, Bloomberg tells us

The Biden administration is giving new powers to an office within the Health and Human Services Department to take a more prominent role in responding to public health crises, spanning from pandemics to natural disasters.
HHS’s Office of the Assistant Secretary for Preparedness and Response will be renamed and enabled to “mobilize a coordinated national response more quickly and stably during future disasters and emergencies,” Dawn O’Connell, who heads the unit, said in a memo obtained by Bloomberg News.
The office will be rebranded the Administration of Strategic Preparedness and Response and will be reclassified an operating division alongside other major health agencies like the Centers for Disease Control and Prevention and the Food and Drug Administration, according to the memo. Those agencies, along with the National Institutes of Health, have been criticized for their response and messaging since the outbreak of Covid-19 more than two years ago.
In the memo, O’Connell wrote that the ASPR had taken on an increasingly important role during the pandemic and that the new designation would equip the unit with “greater hiring and contracting capabilities.”

From the Omicron and siblings front —

The American Hospital Association informs us

The Centers for Disease Control and Prevention last night endorsed the two-dose Novavax COVID-19 vaccine as a COVID-19 vaccine primary series for emergency use in adults, as recommended by its advisory committee. Authorized by the Food and Drug Administration last week, the protein-based vaccine offers an option to individuals who may have an allergic reaction to or prefer not to receive an mRNA vaccine.
CDC today updated its COVID-19 vaccine guidance to include the Novavax vaccine, and issued a chart summarizing the dosing schedules for all authorized or approved COVID-19 vaccines.
In other vaccine news, a new study by the National Institutes of Health comparing the effectiveness of COVID-19 vaccine boosters against the omicron variant found neutralizing antibody levels decreased substantially within three months, with the BA.4 and BA.5 sub-lineages up to 2.5 times less susceptible to neutralization. NIH said the results could help inform decisions regarding future vaccine schedule recommendations, including the need for variant vaccine boosting.

The Wall Street Journal reports

A serious inflammatory complication that strikes some children in the weeks following a Covid-19 infection has almost disappeared. A buildup of immunity and changes to the virus both likely play a part, pediatric infectious-disease doctors and researchers said.
Multisystem inflammatory syndrome is afflicting far fewer children as a proportion of known Covid-19 cases than during earlier waves of the pandemic, according to data from the Centers for Disease Control and Prevention. The condition, also known as MIS-C, is similar to Kawasaki disease, another rare pediatric inflammatory condition. Early in the pandemic, doctors believed they were seeing Kawasaki disease but soon recognized MIS-C as a distinct condition associated with an earlier Covid-19 infection.
MIS-C can cause inflammation two to six weeks after infection with Covid-19 in organ systems including the heart, lungs, kidneys and brain. Researchers haven’t determined why some children developed the condition but they have linked it to a hyperactive immune response. Treated with drugs such as intravenous immune globulin or corticosteroids, most children make a full recovery. Even so, the condition can be deadly. In the U.S., 70 children have died from MIS-C since the start of the pandemic, according to the CDC.

From the fraud, waste and abuse front —

Fierce Healthcare tells us

Federal prosecutors charged 36 defendants with committing a variety of alleged schemes to bilk Medicare using telehealth, as regulators continue to tinker with how to make the COVID-19 telehealth boom permanent.
The Department of Justice announced on Wednesday that the defendants allegedly engaged in a series of actions that led to $1.2 billion in medical fraud, with much of that coming from phony telehealth claims for advanced genetic testing and unnecessary medical equipment.
“Fraudsters and scammers take advantage of telemedicine and use it as a platform to orchestrate their criminal schemes,” said Luis Quesada, assistant director in the FBI’s Criminal Investigative Division, in a statement. “This collaborative law enforcement action shows our dedication to investigating and bringing to justice those who look to exploit our U.S. health care system at the expense of patients.”

Here’s a link to the HHS Office of Inspector General fraud alert which provides background on these telehealth schemes.

The Justice Department also announced

Inform Diagnostics, Inc., (Inform) formerly known as Miraca Life Sciences, Inc. (Inform), has agreed to pay $16 million to resolve allegations that it submitted false claims for payment to Medicare and other federal health care programs.
Inform is a clinical laboratory headquartered in Irving, Texas, that provides anatomic pathology services to physician practices throughout the United States. On April 27, 2022, Fulgent Genetics purchased Inform, and the company is now a wholly owned subsidiary of Fulgent Genetics.
According to the settlement, Inform admits that, between 2013 and 2018, it routinely and automatically conducted additional tests on biopsy specimens prior to a pathologist’s review and without an individualized determination regarding whether additional tests were medically necessary. The United States contends that Inform’s policy of conducting routine additional tests caused Inform to perform many tests that were medically unnecessary. Inform submitted these medically unnecessary tests for payment, causing federal health care programs to pay for false claims. * * *
“Submitting claims for medically unnecessary tests threatens the integrity of the federal health care programs and wastes taxpayer dollars,” said Amy K. Parker, Special Agent in Charge of the Office of Personnel Management’s Office of Inspector General. “Today’s settlement is a reminder to all providers that the OPM OIG will not tolerate fraud against the Federal Employees Health Benefits Program.”

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health subsidiary myNEXUS recently launched a post-acute care program for Medicare members in Indiana, and the insurance giant is aiming to take it nationwide over the next year.
During the company’s earnings call Wednesday morning, CEO Gail Boudreaux said it plans to take the next six to 12 months to scale up the program, which uses a capitated risk-sharing arrangement. The platform arms docs with technology tools that aim to optimize patient care post-discharge. * * *
The company reported $1.7 billion in profit for the second quarter of this year, down from $1.8 billion in the second quarter of 2021 or by 7.8%. Revenues for the quarter were up, however, increasing by 14.1% to $38.6 billion.

Healthcare Dive tells us

JPMorgan Chase’s healthcare venture arm plans to invest $30 million in Centivo, a health plan for self-funded employers. It’s Morgan Health’s third major investment in a startup looking to lower the costs of employer-sponsored healthcare in the past year.
Three-year-old health plan administrator Centivo contracts with providers on behalf of large employers with the goal of improving quality and efficiency. The startup, which ties payments to patient outcomes, says it saves employers 15% to 30% annually compared to traditional health plans.
Morgan Health has shelled out at least $85 million in the past year, including the Centivo deal. The unit invested $50 million in value-based primary care company Vera Whole Health in August and $5 million in healthcare navigation startup Embold Health in March.

From the U.S. general healthcare front —

Forbes offers an interesting article about health insurance literacy in our country. The No Surprises Act has spurred people to look more carefully at their healthcare provider bills, but their analyses fall short because they need help understanding those bills and health insurance coverage.

Yale New Haven Hospital’s July newsletter provides good advice on avoiding skin cancer and stay safe in the summer. The FEHBlog was born at the facility’s predecessor Grace New Haven Hospital.

STAT News reports “Gestational diabetes is on the rise, climbing 30% between 2016 and 2020, according to a new study published Tuesday by the Centers for Disease Control and Prevention. “There is a growing maternal health crisis in the United States, and gestational diabetes is an important and common complication that requires new focus,” said Sadiya Khan, an assistant professor of medicine and preventive medicine at the Northwestern University Feinberg School of Medicine, who was not involved in the new study. “That inflection point there is really striking and something that we’re going to want to follow up [on].” * * * “This issue does not resolve with the pregnancy and is really one that we need to focus on before, during, and after pregnancy for those at risk.”

STAT News also explores the work of various mental health crisis centers in the days following the launch of the nationwide 988 suicide / mental health crisis hotline. Here’s a link to an HHS site that refers to the hotline more appropriately as a LifeLine.

Midweek Roundup

David Ermer–COVID-19, COVID-19 vaccine, NIH, Rx coverage, U.S. Healthcare–July 13, 2022October 10, 2022

From the Omicron and siblings front, MedPage Today informs us

As expected, the FDA has granted an emergency use authorization (EUA) for Novavax’s COVID-19 vaccine in adults, the agency announced on Wednesday.
The decision follows a near-unanimous FDA advisory committee recommendation more than a month ago, with the EUA reportedly delayed in order to allow regulators time to review recent changes to the vaccine’s manufacturing process.
Novavax’s product is a protein subunit vaccine that contains the SARS-CoV-2 spike protein plus an adjuvant to enhance the recipient’s immune response. The product is to be administered as a two-dose primary series given 3 weeks apart.

Becker’s Hospital Review discusses the White House’s latest Covid strategy.

From the No Surprises Act front, the U.S. Office of Personnel Management issued a carrier letter today on various NSA topics affecting FEHB carriers.

From the Rx coverage front

The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
On July 26, 2022, as part of ICER’s Early Insights Webinar Series, ICER’s Senior Medical Advisor Francesca Beaudoin, MD, PhD, MS will present the initial findings of this draft report. This webinar is exclusively available to all users of the ICER Analytics platform; registration for the webinar is now open.

From the Dobbs front, Healthcare Dive has created a state abortion law tracker and the Department of Human Resources announced the steps that its agencies have taken to protect reproductive rights.

From the research studies department, the National Institutes of Health announced today

The percentage of methadone-involved overdose deaths relative to all drug overdose deaths declined from January 2019 to August 2021, according to a new study. Access to methadone, a medication to treat opioid use disorder, was expanded at the start of the COVID-19 pandemic to allow more patients to take home doses, rather than visit a clinic daily. These data indicate that broader access to treatment was not associated with harms. While drug overdose deaths both with and without methadone increased in the month of March 2020, overdose deaths that did not involve methadone continued to increase in the months after the policy changes, while overdose deaths involving methadone held steady.
Published today in JAMA Psychiatry, this study was a collaborative effort led by researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and the National Center for Injury Prevention and Control, part of the Centers for Disease Control and Prevention.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, SDOH–July 11, 2022October 10, 2022

From Capitol Hill, the Hill provides a useful outline of scheduled Congressional activities for this week.

From the Omicron and siblings front,

Becker’s Hospital Review reports

BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Time reported July 11.
Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance.
The subvariant is gaining traction in India and has also been detected in 10 other countries.

Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.

The Wall Street Journal informs us

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.
The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.
In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.
In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.

What about BA.2.75?

An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.

The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.

Medscape tells us

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.
Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.
The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.
The analysis was published online July 6 in NEJM Evidence.
Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.

Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.

From the Rx coverage front, Fierce Pharma reports

Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.
HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.
HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.
At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.

FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.

From the SDOH front, Health Payer Intelligence informs us

The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.
“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release.
“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”

Bravo.

The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.

Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed.
The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.

Fingers crossed for this important initiative.

Midweek Update

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, Telehealth, U.S. Healthcare–July 6, 2022October 10, 2022

From Capitol Hill, Fierce Healthcare reports

Senate Democrats have narrowly reached a deal on legislation to give Medicare the power to negotiate for lower drug prices.
The Senate released text Wednesday (PDF) on the deal that also repeals the controversial Part D rebate rule and installs a cap on monthly cost-sharing payments for Part D and Medicare Advantage plans.
The legislative text shows that starting in 2026, the Department of Health and Human Services will choose 10 drugs eligible for negotiation. The next year, the number of eligible drugs will increase to 15, and in 2029 and every year after by 20.
The sole-source drugs subject to negotiation will be chosen based in part on their total spending under Medicare Parts B and D. There is an exception for small biotech drugs from 2026 through 2028 such as vaccines and excludes certain orphan drugs as well.

Roll Call adds “Congress is fast approaching its scheduled August recess, followed by peak campaign season, so Democratic lawmakers only have a few more weeks in session to push their legislative priorities before they could lose control of either chamber in November.”

From the Omicron and siblings front, the American Hospital Association tells us

The Food and Drug Administration today authorized state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir and ritonavir) to patients as a treatment for those at high risk of severe COVID-19. Because Paxlovid must be taken within five days of symptom onset, the change could spur expanded access and more-timely treatment of eligible patients. The change was made through an amended emergency use authorization.

This standing order approach should accelerate the continuing rollout of test to treat locations.

Regrettably the Wall Street Journal adds

Governments, drugmakers and vaccination sites are discarding tens of millions of unused Covid-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. * * *
In the U.S., about 90.6 million Covid-19 doses have been wasted, or 11.9% of the more than 762 million Covid-19 vaccine doses delivered since the shots became available in late 2020, according to the Centers for Disease Control and Prevention.
The wastage rate has accelerated recently: Some 12 million of the discarded doses have been thrown out since late May.
The disposals come during a significant drop in demand for Covid-19 vaccines, even with young children recently becoming eligible. The seven-day moving average of doses administered daily in the U.S. was about 155,000 as of June 21, down from about 1.1 million on Jan. 1 and the peak of about 3.5 million daily in April 2021.
Partly driving the wastage, health experts said, is the way the Covid-19 vaccines are packaged in multiuse vials containing from five to 20 doses. Once opened, the vials generally must be used within about 12 hours of opening or the remaining doses discarded.

From the telehealth front

Healthcare Dive reports

COVID-19 made its way back into the top five telehealth diagnoses nationally on Fair Health’s monthly tracker in April for the first time since January, according to the report out Wednesday.
Every U.S. census region except the South saw COVID-19 return to the top five diagnoses list, and the uptick is in line with rising cases reported in April by the Centers for Disease Control and Prevention.
Telehealth use overall also rose nationally and in every region after two months of decline, the report found.

Fierce Healthcare informs us

Teladoc is further building out its primary care offering, Primary360, with new services that enhance care coordination and grow in-home options.
Primary360 will now provide care coordination support and health plan in-network referrals alongside free same-day medication delivery from Capsule and in-home, on-demand phlebotomy services backed by Scarlet Health, according to an announcement Wednesday from Teladoc.
The new care coordination capabilities will allow Primary360’s care team to take a “holistic” view of the patient’s coverage and make streamlined referrals to Teladoc services they can access. The care team can also then ensure a patient is referred to an in-network provider when in-person services are necessary.

mHealth Intelligence reports “The burgeoning mental health epidemic in America is widespread across age groups, but the youth have faced a particularly challenging time amid the COVID-19 pandemic. As the youth mental health crisis reaches new heights, providers are increasingly turning to telehealth to help expand access to behavioral healthcare.”

In the same spirit, Health Data Management discusses best practices for hospitals interested in providing acute care at home services.

From the U.S healthcare front, Beckers Hospital Review calls our attention to the fact that “Money, formerly Money Magazine, and Leapfrog Group collaborated for their first shared ranking of “best hospitals” to help consumers make decisions about which healthcare institutions are best for their money. The inaugural list was released July 6 and can be found in full here.” Check it out.

From the fraud, waste and abuse front, Healthcare Dive reports

The federal government won or negotiated more than $5 billion in healthcare fraud judgments and settlements in its 2021 fiscal year, the largest amount ever in the history of the HHS and Department of Justice’s fraud and abuse enforcement program.
Due to those and other efforts from previous years, the government clawed back almost $1.9 billion, according to a new report from the departments.
Of that $1.9 billion, about $1.2 billion went to the Medicare trust funds, which are on increasingly precarious financial footing due to growing stress on the insurance program. In addition, roughly $99 million in federal Medicaid money was transferred back to the CMS.

Finally, Govexec brings us up to date on projections for 2023 annual raises for federal employees.

President Biden and House appropriators seem thus far to be in agreement that federal employees should receive an average 4.6% pay raise next year, but there are still several steps officials must take before it can be implemented at the end of the year. * * *
On Capitol Hill, there are still a few opportunities for federal employee groups and some lawmakers to try to increase the raise to the average 5.1% figure they have been advocating for.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–July 1, 2022October 10, 2022

Happy National Postal Workers Day!

Using the CDC’s Covid Data Tracker and Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 26th week of 2022:

The CDC did not produce its weekly review of Covid statistics today as it’s the beginning of the July 4th holiday weekend. The CDC’s daily averages of new cases, new deaths and new hospitalization for the past week has been 109,944 cases, 316 deaths and 4,947 hospitalizations.

Beckers Hospital Review informs us

Temporary loss of smell emerged as a common indicator of COVID-19 early in the pandemic. Research into the cause and treatment of the condition, known as anosmia, is ongoing, though recent studies have brought us one step closer to answers.
Two latest findings on COVID-19-related anosmia:
1. Loss of smell and taste is becoming less common as the virus evolves, according to researchers.
2. Smell and taste hasn’t fully returned for many people who contracted COVID-19 early in the pandemic, research shows.

In retrospect, the FEHBlog is pleased that he continued theses charts from the last six months of 2021 into the first half of 2022 because doing so captured the three important surges. Now the FEHBlog has to decide what to do next Friday as the charts present a years worth of data.

Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (the 51st week of 2020) through this week, the 26th week of 2022.

It’s worth adding that the CDC is currenly providing weekly, not daily, vaccination stats. The CDC is now offering on a colorful, adjustable chart on “Primary Series Completion, Booster Dose Eligibility, and Booster Dose Receipt by Age, United States.

Medscape adds

COVID-19 vaccines protected against severe disease and death in people with overweight or obesity, a large English study found.
Compared with the unvaccinated, vaccinated individuals in each BMI group experienced significantly lower likelihood of COVID-related hospitalization starting at 2 weeks from their second dose, reported Carmen Piernas, PhD, of the University of Oxford, and colleagues:
* Underweight: OR 0.51 (95% CI 0.41-0.63)
* Normal weight: OR 0.34 (95% CI 0.32-0.36)
* Overweight: OR 0.32 (95% CI 0.30-0.34)
* Obesity: OR 0.32 (95% CI 0.30-0.34)

In other vaccine news, Medscape reports

A new study provides more evidence that influenza vaccination may help protect older adults against Alzheimer’s disease (AD).
In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.
“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings ― that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years ― adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, with McGovern Medical School at the UTHealth, Houston, Texas, told Medscape Medical News.

Sign me up.

Also from the public health front, Medscape tells us

About 80% of US adults have low to moderate cardiovascular (CV) health based on the American Heart Association (AHA) checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health. With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist. * * *
The AHA Presidential Advisory — Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health — was published online June 29 in the journal Circulation.
A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.
Overall, the results show that CV health of the US population is “suboptimal, and we see important differences across age and sociodemographic groups,” [Dr. Donald] Lloyd-Jones [chair of the department of preventive medicine at Northwestern University’s Feinberg School of Medicine in Chicago] said.

Medpage offers a detailed Q&A on monkeypox. Among them

Could monkeypox be spread easily from person to person, similar to COVID-19?
“Monkeypox is certainly not COVID-19,” stressed [Capt. Agam] Rao [, MD, a medical officer at the U.S. Public Health Service at the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)]. Based on prior outbreaks and the current outbreak, monkeypox appears to spread through “direct close contact. So, intimate contact that might happen during sex, but also any other close contact that might occur — for example, if you live with someone who has monkeypox and you are sleeping on the same bedding and using the same towels.”
“It really is not something that you will just pass on to someone walking down the street,” she said.
While agency researchers are “keeping an open mind” about the possibility that the virus could be more easily transmitted, “at this time, there’s no indication that it would spread the way that COVID spread and spread to as many people, [and] at this time, the risk for the worldwide population … is low,” she added.

From the prior authorization front, Healthcare Dive reports

Aetna is no longer requiring prior authorization for cataract surgeries, a controversial policy the payer adopted a year ago, according to a new provider notice.
Aetna is also rolling back prior authorization requirements for video EEGs and home infusion for some drugs. It’s adding two new-to-market drugs to the precertification list.
The payer said in a statement that it came to its decision after analyzing real-time data from the year the requirement was in place. “Going forward, we will focus on retrospective reviews of procedures and providers where questions of medical necessity exist,” Aetna said.

From the Rx coverage front, Fierce Pharma offers an article on how payers are planning to avoid cost shocks associated with gene therapy.

Kelley Miller, senior director of managed markets for the specialty pharmacy Optum Frontier Therapies, said there are three major considerations for his team during coverage talks. One is the clinical landscape, while another is the “human” element of what the patients and their families are going through. Thirdly, the team looks at the “economic impact” of the treatment.
Once Miller’s team has that information, the “conversations should come fast and furious,” he said.
Despite the biopharma industry’s advances in gene therapies, ICER president Steven Pearson, M.D., M.Sc., said it’s still a “fairly dicey business proposition” for companies in this field, especially outside the U.S. He pointed to bluebird bio’s decision to pull beta thalassemia gene therapy Zynteglo from the European market last year.

From the U.S. healthcare front, Beckers Hospital Review reports

IBM Watson Health, in partnership with Fortune, has released its top 15 health systems, which they find set an example for health systems and hospitals across the nation. With its data, the report will continue to stand as a resource for these groups to improve their quality of care and efficiency.
In its 14th year of publishing this study, IBM Watson Health found that the top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. The study also found that patients revered the top 15 hospitals more than peer system hospitals.

For 2022, Allina Health of Minneapolis, MN, sits on top of the large health systems division. Cone Health of Greensboro, NC, sits on top of the medium health systems division. Asante of Medford Oregon sits on top of the small health system division.

From the Medicare Advantage front, Health Payer Intelligence discusses AHIP’s statement on the Medicare Advantage program which places various attacks against the MA program in perspective.

In addition to defending prior authorizations and spotlighting certain facets of OIG reporting, AHIP also offered evidence for Medicare Advantage plans’ efficacy overall.
The health plans have been proven to excel on quality measures and on overall efficiency, surpassing original Medicare’s quality level. They also have to ascribe to certain network adequacy standards.
Medicare Advantage plans produce savings for the Medicare program and offer higher value for members and taxpayers. In particular, Medicare Advantage plans offer strong value to members who are lower-income and underserved.
Lastly, AHIP pointed out that these plans have bipartisan support.

Finally federal employee benefits consultant Tammy Flanagan follows the retirement process of a federal employee in a three-part article in Govexec.

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