Friday Stats and More

OPM

Friday Stats and More

David Ermer–CDC, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and Thursday as the first day of the week, the FEHBlog presents his weekly chart of new Covid cases for 2022.

The CDC’s weekly interpretation of its Covid statistics reports

As of October 12, 2022, the current 7-day moving average of daily new cases (38,949) decreased 11.9% compared with the previous 7-day moving average (44,233). 

CDC Nowcast projections* for the week ending October 1, 2022 estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are eight designated as Omicron: BA.5, BA.4.6, BQ.1.1, BQ.1, BF.7, BA2.75.2, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 67.9% (95% PI 64.1-71.4%).

The Wall Street Journal points out

New offshoots of the Omicron Covid-19 variant that virus experts say appear to spread easily are on the rise in the U.S., the latest federal data show, underscoring how the virus is mutating and presenting new risks as it proliferates.

Two of the Omicron subvariants, both related to the BA.5 version that drove the most recent U.S. surge, are called BQ.1 and BQ.1.1. They were estimated to represent a combined 11.4% of U.S. Covid-19 cases by mid-October, according to estimates the Centers for Disease Control and Prevention released Friday. * * *

Virus experts said that, because the newer subvariants remain in the Omicron family, updated Covid-19 vaccines in the U.S. should be an important shield against severe illness and death, though data is limited. The bivalent shots were designed to fight the original virus strain as well as the BA.4 and BA.5 Omicron subvariants.

Here is the CDC’s “Daily Trends in Number of New COVID-19 Hospital Admissions in the United States” chart.

The CDC’s summary explains “The current 7-day daily average for October 5–11, 2022, was 3,268. This is a 4.4% decrease from the prior 7-day average (3,419) from September 28–October 4, 2022.”

The Wall Street Journal adds

Nationally, key metrics such as hospitalizations have largely been on a downward trajectory since late July, following a BA.5-fueled summertime surge, but with some recent signs of wavering. Wastewater virus readings have been choppy in recent weeks due to a climb in the Northeast, according to data from Biobot Analytics. The Northeast has also seen a recent rise in new Covid-19 hospital admissions, federal data show.

The FEHBlog presents his weekly chart of new Covid deaths for 2022

The CDC’s summary explains “The current 7-day moving average of new deaths (328) decreased 8.5% compared with the previous 7-day moving average (359).”

The Wall Street Journal adds

The country has recently averaged about 330 newly reported Covid-19 deaths each day, a continued burden falling heavily on the elderly and people with underlying health issues, including compromised immune systems. * * *

The interplay of a changing virus and fading immune protection from earlier infections and vaccine shots has left people vulnerable to repeated cases. These can lead in some cases to long-running symptoms. But virus experts say built-up protections from vaccines and prior infections still matter and can help limit hospitalizations and deaths.

The FEHBlog presents his weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 41st week of 2022:

The CDC’s summary explains

As of October 12, 2022, 627.9 million vaccine doses have been administered in the United States. Overall, about 265.1 million people, or 79.9% of the total U.S. population, have received at least one dose of vaccine. About 226.2 million people, or 68.1% of the total U.S. population, have completed a primary series.

It strikes the FEHBlog as odd that the CDC’s Covid daily reporting does not include dispensing of oral antiviral drugs for Covid treatment, a vital component of the Covid suppression strategy.

Yesterday, the Secretary of Health and Human Services renewed the Covid public health emergency for another 90 days. The American Hospital Association comments

The AHA had urged HHS to renew the public health emergency to continue critical flexibilities hospitals depend on to deliver needed care, and minimize additional disruptions to an “increasingly fragile” health care delivery system.

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

UnitedHealth beat Wall Street expectations on both earnings and revenue in the third quarter with revenue of $80.9 billion, up 12% year over year. The healthcare giant increased its 2022 earnings expectations as a result.

Minnetonka, Minnesota-based UnitedHealth chalked the rise up to an increase in members served by payer UnitedHealthcare and growth in value-based care arrangements and care delivery platforms at Optum. Both businesses reported double-digit growth.

On a call with investors Friday morning, CFO John Rex said that UnitedHealth expects Change Healthcare — the data analytics business UnitedHealth acquired earlier this month despite a challenge from regulators — to be accretive to Optum’s earnings next year, not in 2022 as previously expected.

From the FEHB front

  • Kaiser Health News reports on a “New Generation of Weight Loss Medications Offer Promise — But at a Price.” FEHB plan enrollees will find expanded coverage of the drugs for 2023 due to a sensible OPM requirement in the 2023 call letter.

In other open season news, the Department of Health and Human Services issued a press release on the Medicare Open Enrollment period, which begins on Saturday, October 15.

Thursday Miscellany

David Ermer–CMS, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the COLA front —

Federal News Network informs us

Federal retirees and Social Security recipients are about to get the largest increase in their cost-of-living adjustment (COLA) in over four decades.

The COLA will increase 8.7% for 2023, the Social Security Administration announced on Oct. 13. But not all federal retirees will see that amount added to their checks. Those in the Federal Employee Retirement System (FERS) will receive a 7.7% COLA starting in January.

In contrast to the Civil Service Retirement System, whose annuitants receive the 8.7% COLA, FERS is integrated with Social Security retirement benefits. Consequently, FERS annuitants will receive the 8.7% COLA on their Social Security benefits. Here’s the government’s Social Security 2023 Changes Fact Sheet.

The Society for Human Resource Management offers Social Security tax changes information relevant to employers and employees.

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

The retooled Covid-19 booster from Pfizer Inc. and BioNTech SEgenerated a strong immune response against the Omicron substrains BA.4 and BA.5, the companies said. 

The data, which the companies reported in a news release Thursday, offer the first window into how the new shots rolling out across the U.S. perform.

An early look at data from ongoing testing in people at least 18 years old found the booster generated higher levels of neutralizing antibodies against the two substrains compared with levels measured before the extra shot, the companies said.

Researchers also found the vaccine, called bivalent because it targets both the Omicron substrains as well as the original strain of the virus, was well-tolerated and worked safely.

From the monkeypox front, the New York Times Morning column assesses the lessons that “Monkeypox’s decline has for future disease outbreaks.”

Ultimately, monkeypox in the U.S. has been contained to a narrow demographic, mostly gay and bisexual men with multiple partners. It was never very deadly; there were just 28 confirmed deaths globally out of more than 72,000 reported cases. (I wrote earlier about the virus and how it spreads.)

Four factors explain monkeypox’s decline, experts said. First, vaccines helped slow the virus’s spread (despite a rocky rollout). Second, gay and bisexual men reduced activities, such as sex with multiple partners, that spread the virus more quickly.

The third reason is related: the Pride Month effect. Monkeypox began to spread more widely around June, when much of the world celebrated L.G.B.T.Q. Pride. Beyond the parades and rallies, some parties and other festivities involved casual sex. As the celebrations dwindled, so did the increased potential for monkeypox to spread.

And finally, the virus simply burned out. Monkeypox mainly spreads through close contact, making it harder to transmit than a pathogen that is primarily airborne, like the coronavirus. “Because of that, monkeypox is a self-limiting virus,” Apoorva told me. That made it less likely to grow into a larger outbreak.

Much of this explanation may sound familiar after more than two years of Covid: A virus can be tamed by vaccines and behavioral changes.

From the public health front, the UnitedHealth Foundation released the Sixth edition of its U.S. Health Rankings for Women and Children.

The 6th edition of America’s Health Rankings® Health of Women and Children Report shines a light on the health challenges faced by the nation’s women and children. The report builds on United Health Foundation’s commitment to support better health and encourages others to join in building healthier communities.

Visit the Health of Women and Children Report Action Toolkit to access additional resources that can help you share the data with relevant stakeholders and enact change.

This year, the Health of Women and Children Report finds that:

* Rates of mental and behavioral health challenges have increased broadly among women and children across the nation in recent years, though rates vary widely based on geography, race/ethnicity and socioeconomic factors.
* The overall mortality rate among women ages 20-44 increased dramatically during the first year of the COVID-19 pandemic, exacerbating existing disparities.
* The pandemic underscored the need to address long-standing disparities in maternal mortality and morbidity, which continue to disproportionately burden Black and American Indian/Alaska Native women.
* In the first years of the COVID-19 pandemic, several socioeconomic and environmental conditions that shape health worsened. Women experienced record-high unemployment and markers of health related to children’s neighborhoods and home environments declined.
* The healthiest states are Minnesota, Massachusetts, Vermont, New Jersey and Utah. Louisiana had the most opportunity to improve, followed by Arkansas, Mississippi, Oklahoma and Alabama.

STAT News adds

In the numbers game of disease statistics, type 1 diabetes takes a back seat to type 2 diabetes, which accounts for more than 95% of diabetes cases around the globe. But the impact of type 1 diabetes (T1D), which tends to emerge earlier in life and can quickly kill an individual if it goes unrecognized or untreated, is huge. Its global burden, however, hasn’t been well understood — until now.

With the proper care and treatment, including access to insulin, which people with type 1 diabetes must use every day, individuals can live long and healthy lives with this disease. But many in the United States and countries around the world do not have access to even the most basic treatments.

To assess the impact of type 1 diabetes, JDRF, the organization [the author] lead[s], and its global partners created the Type 1 Diabetes Index (T1D Index), a first-of-its-kind tool, to identify and address the wide gaps in knowledge about the incidence and impact of type 1 diabetes country by country. With this knowledge, interventions can be developed that will save lives and improve the health of those living with the disease.

From the U.S health care business and innovations front —

Healthcare Dive reports

Walgreens expects its U.S. Healthcare division, which includes primary care chain VillageMD, specialty pharmacy company Shields Health Solutions and at-home care provider CareCentrix, to reach profitability in 2024, CEO Roz Brewer told investors on a Thursday call for Walgreens’ fourth-quarter results.

Walgreens is also increasing its long-term sales outlook for the new division to between $11 billion and $12 billion in sales by 2025, with VillageMD being the largest contributor. In the 2022 fiscal year, U.S. Healthcare brought in $1.8 billion in sales.

Despite a net loss in the fourth quarter, the Deerfield, Illinois-based pharmacy chain beat analyst expectations for both earnings and revenue.

and

GoodRx — the consumer-facing, digital drug discount startup — is launching a new version of its platform that is tailored for providers.

Doctors, medical office staff and other healthcare workers have already been using the consumer-facing version to help patients find discounts and programs to help them afford prescribed medications, GoodRx Executive Medical Director Preeti Parikh, said.

Targeting providers directly is a pivot from GoodRx’s traditional consumer focus, but the company found it necessary and sees an opportunity to capture more pharmaceutical advertising revenue in the process, she said.

Fierce Healthcare tells us

The hospital industry’s recent shift toward fewer, but larger, merger and acquisition deals continued through the third quarter of 2022, according to a new report.

There were 10 hospital and health system transactions announced from July through September by advisory firm Kaufman Hall’s count—up slightly from last year’s seven announced deals but still well below the 19 from 2020 or the 25 from 2019.

The total transacted value of those 10 deals, however, exceeded nearly all of the third-quarter totals measured by the firm in the last seven years.

The past three months’ $8.3 billion handily outpaced 2021’s $5.2 billion and 2020’s $7.4 billion, the firm wrote, and is only beaten by the $10.8 billion recorded among 19 deals back in 2018.

and

Pacific Northwest insurer Regence is teaming with MultiCare Connected care to roll out a new tool that aims to ease the administrative burden of prior authorization.

Regence and MultiCare, an accountable care organization, will be the first in the nation to roll out new prior authorization standards backed by HL7’s Fast Healthcare Interoperability Resources, or FHIR. As FHIR is supported by most electronic health records, the tool can be embedded directly in physicians’ workflows and enables them to receive near real-time determinations.

Finally, OPM announced

The U.S. Office of Personnel Management (OPM) announced that the Honorable Denis McDonough, Secretary of the U.S. Department of Veterans Affairs (VA) and U.S. Office of Personnel Management (OPM) Director Kiran Ahuja will be serving as the National Honorary Co-Chairs of the [ongoing] 2022 Combined Federal Campaign (CFC). 

 The CFC is a 61-year annual giving tradition that allows the Federal workforce to donate directly to thousands of eligible charities and causes locally, nationwide, and throughout the world. Through the contributions of Federal employees, military employees, and retirees, the 2021 CFC raised over $80 million. An additional Special Solicitation took place earlier this year to benefit those affected by the war in Ukraine.   

The campaign run from September 1st, 2022 through January 14, 2023. 

Mid-week Update

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, NCQA, NIH, OPM, Rx coverage, U.S. Healthcare–

Following up on this week’s posts

Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.

Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.

This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.

That’s not the case in the FEHB Program. Moreover,

The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.

That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.

From the Omicron and siblings’ front —

The Associated Press reports

The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.

Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *

So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”

The American Hospital Association informs us

The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.

MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”

In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is

Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus. 

From the medical research front —

Healthcare Dive reports

Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.

Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.

It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.

The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.

This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.

Kudos to the winners.

STAT News reports

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.

Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.

From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”

From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.

From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:

Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021

Friday Stats and More

David Ermer–CDC, COVID-19, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–

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

The CDC’s Covid Data Tracker Weekly Review was not issued today because Monday is a federal holiday.

The Covid Weekly Tracker tells us that the daily average of new Covid hospital admissions is 3,35.

Here is the FEHBlog’s latest weekly chart of new Covid deaths.

New York Times columnist David Leonhardt, who is going on a book tour that ends in late January 2023, reports

“A large chunk of deaths are preventable right now with Paxlovid alone,” Dr. Ashish Jha, the White House Covid response coordinator, told me. He predicted that if every American 50 and above with Covid received a course of either Paxlovid or a treatment known as monoclonal antibodies, daily deaths might fall to about 50 per day, from about 400 per day in recent months. * * *

A recent analysis of about 568,000 patients by Epic Research found that 0.016 percent of Covid patients over 50 who received Paxlovid died. The death rate for patients who did not get the drug was more than four times higher, or 0.070 percent. And yet the Epic data showed that only about 25 percent of patients eligible to receive Paxlovid actually did, even though the drug is widely available and free for patients.

Perhaps the most shocking statistic about Paxlovid’s underuse — and Jha used the word “shocking” when describing it to me — is that a smaller share of 80-year-olds with Covid in the U.S. is now receiving the drug than 45-year-olds with Covid, according to data he has seen. Many doctors are evidently worried about side effects or rebound cases among their more vulnerable patients.

Even in rebound cases, however, symptoms tend to be milder than they would have been without Paxlovid. After Dr. Anthony Fauci, another White House adviser, who’s 81, contracted Covid in June and then took Paxlovid, he experienced a rebound — and also believed that the drug kept him out of the hospital.

“Medicine is about weighing costs and benefits,” Wachter said. “The recommendation should be clear and unambiguous for people at high risk: The benefits of the drug outweigh the downsides.”

In contrast, STAT News reports

A Merck pill used to combat Covid-19 failed to demonstrate it can lower the risk of hospitalization compared with a placebo among adults at a higher risk from the disease, according to the results of a large study conducted in the U.K.

The preliminary results of the randomized trial, which involved more than 25,000 participants, showed that taking molnupiravir did speed time to recovery by about six days, which means that patients did get some relief. Otherwise, though, the study failed to reach an outcome that had been used late last year by regulators — such as those in the U.S. and U.K. — to authorize the medicine to thwart the pandemic.

The findings also contradict the results of a much smaller study conducted by Merck and its partner, Ridgeback Therapeutics, which found a lower risk of hospitalization or death in high-risk patients by roughly 30%, after initially showing a 50% lower risk. Unlike the latest trial, which is called Panoramic, the Merck trial called Move-Out excluded patients who had been vaccinated against the coronavirus.

Here is the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 40th week of 2022:

In addition, here are two related CDC charts.

The American Hospital Association adds

COVID-19 vaccinations are associated with over 650,000 fewer hospitalizations and 300,000 fewer deaths in the Medicare population through December 2021, saving an estimated $16 billion in direct medical costs, the Department of Health and Human Services reported today. 

“This report reaffirms what we have said all along: COVID-19 vaccines save lives and prevent hospitalizations,” said HHS Secretary Xavier Becerra. “We now have updated COVID vaccines designed to protect you against the Omicron strain of COVID that makes up almost all COVID cases in the U.S. … Over 90 percent of Americans live within 5 miles of where they can access these vaccines for free. I urge everyone eligible to get an updated COVID vaccine to protect yourself ahead of the fall and winter.”

Govexec tells us The Office of Personnel Management on Thursday announced that it authorized paid leave for federal workers to obtain the latest round of boosters for the COVID-19 vaccine.

From the FEHB front, Health Payer Intelligence reviews 2023 Blue Cross FEP benefit changes and makes other Open Season observations.

In OPM news, the GSA announced that its Technology Modernization Fund will be investing in OPM’s website.

OPM.gov Modernization

It can be challenging for federal employees, job seekers, and HR professionals to navigate OPM.gov’s 20,000 pages to find what they need. With a $6 million TMF investment, OPM will update both the technology behind and the content on the OPM.gov website. This will allow OPM to implement an updated and more secure Content Management System (CMS) hosted on OPM’s cloud environment, ensuring that users have intuitive and accessible web tools.

“A user-friendly website plays a critical role in OPM’s mission to communicate the federal government’s policies, services, and benefits more clearly and effectively,” said OPM Director Kiran Ahuja. “This investment will improve the government’s ability to recruit job seekers, supply the federal workforce with relevant career-related information, and make it easier for public servants to manage their benefits.”

Hope springs eternal.

From the mental healthcare front, Fierce Healthcare informs us

A mental health crisis besets young adults in the United States to such an extent that more than a third (35%) of individuals ages 18 through 29 years old said that they could not work nor engage in other activities of daily living, according to a new survey by the Kaiser Family Foundation (KFF) and CNN.

Meanwhile, 90% of all Americans believe that the country faces a mental health crisis.

Age 30 seems to be the cutoff separating severe crisis caused by mental health problems, and conditions not as dire. For instance, 34% of those 18 through 29 consider their mental health to be “only fair” or “poor”; 19% of those 30 and over feel that way. Fifty-two percent of young adults said that they’d always or often felt anxious in the last year, while 28% of older adults felt that way.

A third of young adults felt depressed (33%) or lonely (32%) in the last year; for older adults it was 18% for both depressed and lonely. 

These survey figures, particularly the first one, are hard to believe, but undoubtedly our country needs more mental health therapists and better treatments.

From the Rx coverage front, the Food and Drug Administration announced that the agency has

approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. 

“Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.” 

Pertussis is a common respiratory disease in the United States, resulting in frequent outbreaks. It is also called whooping cough because of the “whooping” sound that someone makes when gasping for air after a fit of coughing. Most serious pertussis cases, hospitalizations and deaths occur in infants younger than two months of age who are too young to be protected by the childhood pertussis vaccine series. According to the Centers for Disease Control and Prevention (CDC), 4.2% of the total cases of pertussis reported in the United States in 2021 were in infants younger than 6 months of age and approximately 31% required hospitalization. When the Boostrix vaccine is given during pregnancy, it  boosts antibodies in the mother, which are transferred to the developing baby. 

Good news.

From the healthcare business front, Fierce Healthcare reports

Yale New Haven Health has signed an agreement to acquire two Connecticut health systems, Waterbury HEALTH and Eastern Connecticut Health Network), from Prospect Medical Holdings.

The deal would give Connecticut’s largest health system the businesses, real estate, physician clinic operations and outpatient services of three hospitals: 357-bed Waterbury Hospital, 249-bed Manchester Memorial Hospital and 102-bed Rockville General Hospital. Also included are Prospect Provider Group of Connecticut and Visiting Nurse and Health Services of Connecticut, according to a release.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the OPM front, Federal News Network reports on the Senate Homeland Security and Governmental Affairs September 29, 2022, confirmation hearing for Robert Shriver, whom the President has nominated to serve as OPM Deputy Director.

From the Fourth Quarter 2022 front

  • STAT News provides “The Q4 health tech tracker: 17 key industry events and milestones to watch.”
  • The Society for Human Resource Management offers “4th Quarter 2022 ‘Quick Hits’ for Plan Sponsors.” This quick hit grabbed the FEHBlog’s attention:

Making a splash across the headlines was the Inflation Reduction Act of 2022(IRA), which President Biden signed on Aug. 16, 2022. The 273 pages of text make sweeping changes. However, few will affect employer-sponsored benefit plans, and most of those will have only indirect effects. 

One change that does directly affect a High Deductible Health Plan (HDHP) is the exception added to Section 223 of the Internal Revenue Code effective for plan years beginning after Dec. 31, 2022, to enable HDHPs to cover the cost of insulin without first meeting the deductible. This first dollar coverage for insulin will protect Health Savings Account (HSA) eligibility for those who require an insulin regimen. Employers should determine if their plan requires an amendment to implement this change.

On a related note, TRI-AD calls to our attention the “2022 FSA relief provisions will no longer apply in 2023.”

From the public health front —

  • The American Hospital Association informs us that “Increasing bivalent COVID-19 booster vaccinations this year to 2020-2021 flu vaccination rates could prevent an additional 75,000 deaths and 745,000 hospitalizations and avert $44 billion in medical costs over the next six months, researchers estimate in a Commonwealth Fund blog post. Increasing COVID-19 booster coverage to 80% of eligible Americans aged five and older this year could prevent about 90,000 deaths and over 936,000 hospitalizations and avert $56 billion in medical costs, they add.”
  • CNBC reports

* The CDC, in a report, said monkeypox could spread indefinitely at a low level in the U.S.

* Monkeypox is unlikely to be eliminated from the U.S. in the near future, according to the CDC. 

* The outbreak is slowing as the availability of vaccines have increased and people have become more aware of how to avoid infection.

  • The New York Times gives us a briefing and advice on the upcoming flu season.
  • Beckers Hospital Review discusses patient safety wins obtained this year by five health systems.

From the innovations front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services seeks comments through Dec. 6 on creating a National Directory of Healthcare Providers and Services to help patients locate providers and compare health plan networks, and reduce directory maintenance burden on providers and payers.

CMS seeks feedback on the concept and potential benefits; provider types and data elements to include; the technical framework for a national directory; priorities for a possible phased implementation; and prerequisites and actions CMS should consider to address potential challenges and risks.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Electronic health records, Federal employment benefits, Medicare, Mental health care, OPM, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, OPM released its Open Season press announcement today. Its lede is

Thousands of Enrollees Are Leaving Valuable Savings on the Table During Open Season
Enrollees should use Open Season as a period to conduct a wellness or financial check-up and reassess their health needs and coverage

Among other guidance, OPM recommends

Below we’ve provided sample questions to help you assess how you can utilize Open Season to review your benefits and needs to make an informed decision on coverage:

What are my and/or my family’s expected health care needs for 2023? 

* Questions while reviewing your FEHB plan: Am I expecting a new baby? Do I need surgery? Will my medication need change? Does my plan provide a pharmacy mail order option for prescriptions?

* Questions while reviewing FEDVIP: Do I want coverage for my routine dental care? Will I need a crown or root canal? Does my child need braces? Do I need glasses and/or contact lenses? Am I considering laser vision correction surgery?

* Questions while reviewing FSAFEDS: Do I have out-of-pocket expenses I need to consider, such as deductibles, copays, day care, elder care, or over-the-counter drugs and medicines? Do I have medical expenses that may not be covered by my FEHB plan? Do I plan to send my children (under 13) to in-home care or summer camp? 

OPM does not mention the availability of the FEHB plan’s summary of benefits and coverage (“SBC”), an Affordable Care Act requirement. The FEHBlog recalls visiting friends in Denver who were preparing for their employers’ open season by comparing these short but comprehensive SBCs. For example, the SBCs include a broken-out estimate of the plan’s cost-sharing for having a baby, receiving diabetes treatment for a year, and fixing a broken bone. In addition, the federal government consumer tested the SBCs.

FEHB plans update their SBCs annually in advance of Open Season and post them on their websites, usually on the page with forms and brochures.

The Washington Post has an article on the 2023 Open Season, and Federal News Network offers “a few” other expert views on the 2023 Open Season. Fierce Healthcare adds

Open enrollment is coming soon, and foremost on everybody’s mind as these windows draw nearer is just how much health insurance will cost, according to a survey by Gravie and Wakefield Research.

“Consumers are concerned about the high costs of health coverage impacting their access to healthcare, increasing medical debt and the lack of mental health coverage,” according to a press release from the two companies.

From the Omicron and siblings’ front —

  • Beckers Hospital Review tells us

The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.  * * *

The CDC’s website still deems people who are not immunocompromised as “fully vaccinated” two weeks after their second dose of Moderna or Pfizer’s series or two weeks after receiving J&J’s COVID-19 vaccine. 

[However, last Friday’s] decision could update the “fully vaccinated” term that experts have urged regulators to update.

  • HealthLeaders Media reports “Treating COVID-19 patients with Paxlovid significantly reduces hospitalizations and deaths, according to a recent large-scale study by Epic Research.”

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

  • David Leonhardt writing in the New York Times Morning column discusses “A Public Health Success Story; We revisit the subject of Covid and racial inequities”. Check it out.
  • The NIH Directors Blog considers “Understanding Long-Term COVID-19 Symptoms and Enhancing Recovery.”

From the mental healthcare front, MedPage Today reports

Suicide risk was higher in people recently diagnosed with dementia, especially younger patients, a case-control study in England showed.

Compared with people who didn’t have dementia, suicides rose in people who received a dementia diagnosis in the past 3 months (adjusted OR 2.47, 95% CI 1.49-4.09), according to Danah Alothman, BMBCh, MPH, of the University of Nottingham in England, and colleagues.

For people under age 65, suicide risk within 3 months of diagnosis was 6.69 times (95% CI 1.49-30.12) higher than in patients without dementia, the researchers reported in JAMA Neurology

From the U.S. healthcare business front, Bloomberg reports on giant drug manufacturer Pfizer’s future

Pfizer Inc. emerged from the Covid-19 pandemic as the world’s most visible drugmaker, but its success has left investors impatient for an encore.

The windfall from the pharmaceutical giant’s Covid vaccine almost doubled its revenue in just one year. And now the shot, coupled with Pfizer’s Covid antiviral pill, is poised to make up more than half of its expected $100 billion of sales in 2022. That’s left Pfizer flush with cash — $28 billion it could spend on the kinds of deals that for decades fueled its growth into an American colossus.

The pressure is clearly on for Pfizer to show that the muscle it built during the pandemic won’t atrophy. Big Pharma companies don’t normally double revenue so quickly, and nobody expects that kind of growth to continue. But one thing’s clear: Pfizer can’t go back to the sluggish path it was on for years.

The American Hospital Association informs us

Operating margins for U.S. hospitals and health systems were down 24% in August compared to a year ago, driven in large part by a 7.2% increase in labor expenses, according to data from over 900 hospitals reported yesterday by Kaufman Hall.

“Nine months into a challenging year, margins have fluctuated wildly,” the report notes. “Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.”

From the Medicare front, the American Hospital Association adds

Effective Oct. 1 for five years, the Centers for Medicare & Medicaid Services will pay average sales price plus 8%, rather than ASP plus 6%, for biosimilars whose average sales price does not exceed the price of the reference biological product. The payment increase was included in the Inflation Reduction Act of 2022. For new biosimilars that qualify, the five-year period will begin on the first day of the calendar quarter for which ASP payment for that biosimilar begins under Medicare Part B.

From the electronic health records front, STAT News reports

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

The changes follow the publication of a series of investigations by STAT that found an earlier version of Epic’s tool resulted in high rates of false alarms at some hospitals and failed to reliably flag sepsis in advance. One of the investigations found that the model’s use of antibiotics as a prediction variable was particularly problematic, resulting in late alarms to physicians who had already recognized the condition and taken action to treat it.

Fierce Healthcare looks into “How Google, Mayo Clinic and Kaiser Permanente tackle AI bias and thorny data privacy problems.”

From the telehealth front, Healthcare Dive reports

Telehealth utilization varied by region from June to July of 2022 and rose 1.9% nationally, according to Fair Health’s monthly tracker data out Monday. 

In the West, Midwest and South, telehealth utilization rose 5.7%, 2.5% and 4.9%, respectively, from June to July. In the Northeast, telehealth use fell 3.3% during that period.

Mental health conditions remained the top diagnoses nationally, and psychiatrists also delivered more virtual care in some regions.

Monday Roundup

David Ermer–Congress, Federal employment benefits, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the FEHBlog has noticed that OPM expanded the number of FEHB and FEDVIP public use files available on its website. “The purpose of the OPM FEHB and FEDVIP Plan and Benefits Information (PBI) Public Use Files (PUFs) is to provide information to the public on FEHB and FEDVIP plans, including information on rates and benefits.” Check it out.

The FEHBlog also has noticed that many FEHB plans promptly posted Open Season information on their websites. In particular, the three largest FEHB carriers, Blue Cross FEP, GEHA, and Kaiser Permanente have done so. That’s a heavy, yet helpful, lift so kudos to the carriers.

From the public health front

  • The New York Times brings us up to date on the polio vaccination campaign in New York State.

The specter of polio becoming endemic in America again was once unthinkable. But as state public health officials embark on an urgent campaign to get more people vaccinated, the low rates among preschoolers in some pockets are evidence of both the challenges they face and the threat to the state’s youngest children — the very age group among whom polio is most likely to spread.

This gap stems from the fact that the polio vaccine is required for school admission.

A bipartisan group of lawmakers has proposed legislation to help create drugs that can fight drug-resistant pathogens as the treatments for life-threatening problems from respiratory infections to sepsis stop working.

But a classic end-of-year congressional quagmire — a tight calendar, a heated election season, fights over spending, and inertia — threatens to stymie progress before the end of the year.

Fingers crossed for passage in the lame duck session.

  • The National Institutes of Health released its monthly NIH News in Health, which is worth a click.

From the U.S. healthcare business front —

  • Fierce Healthcare relates “Francisco Partners, an investment firm, signed a definitive agreement to acquire bSwift from CVS Health.” The acquistion agreement is expected to close by year end and “bSwift will continue to partner with CVS Health and its subsidiary Aetna, an insurance provider, by sharing benefits solutions with its employees and clients.”

From the telehealth front, we have another positive survey report from mHealth Intelligence. “ccording to new research findings from the JD Power 2022 US Telehealth Satisfaction Study, telehealth has become more than a temporary replacement for in-person care due to high consumer preference and its role in expanding access to mental health treatment.”

From the Monday miscellany front —

  • BioPharma Dive identifies five Food and Drug Administration decisions to watch out for this quarter. “The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.”
  • The Office of National Coordinator for Health Information Technology issued eight information blocking regulatory reminders for October 6, the end of the phase in period for that rule.
  • Medscape reports on an HHS Office of Inspector General report criticizing the efficiency of the FDA’s accelerated drug approval program.

In granting accelerated approvals, the FDA sets timelines for drugmakers to carry out confirmatory trials. But these target dates are often missed. OIG staff evaluated 104 cases of accelerated approvals for which confirmatory trials have not been completed and found that as of May 5, 2022, 35 drug studies had missed their original target completion dates. * * *

In its report, the OIG staff offered a deep look at the four drugs in which confirmatory trials were furthest past their original completion deadlines:

* Mafenide acetate (Sulfamylon), a topical antimicrobial treatment for burns that was approved in 1998. The trial is 140 months past its original deadline.

* Midodrine hydrochloride (Proamatine), a treatment for postural hypotension that was approved in 1996. The trial is 85 months past its original deadline.

* Pralatrexate (Folotyn), a treatment for T-cell lymphoma that was approved in 2009. The trial is 72 months past its original deadline.

Hydroxyprogesterone caproate (Makena), a drug to reduce risk of preterm birth that was approved in 2011. The trial is 64 months past its original deadline.

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, OPM, U.S. Healthcare–
OPM Headquarters, a/k/a the Theodore Roosevelt Building

Today’s leading stats are FEHB, not Covid related.

This afternoon, OPM released the 2023 FEHB and FEDVIP premiums with a lengthy announcement and a link to those premiums.

Govexec explains

Federal employees and retirees will spend an average of 8.7% more on their health insurance premiums in 2023, a figure that marks the highest cost increase in more than a decade.

The government’s share of Federal Employees Health Benefits Program premiums will increase by an average of 6.6%, bringing the overall increase to 7.2%, according to an OPM document obtained by Government Executive. That overall premium increase is the highest the nation’s largest health insurance program has seen since costs increased 9% in 2011.

On average, federal employees enrolled in “self-only” plans will pay an additional $8.11 per bi-weekly pay period, while feds in “self plus one” insurance plans will pay $20.34 more per pay period. Federal workers enrolled in family coverage will pay an average of $20.87 more per pay period in 2023.

For the Federal Employees Dental and Vision Insurance Program, the average premium for dental plans will increase by 0.21%, while the overall average premium for vision coverage will decrease by 0.41%.

If you follow the FEHBlog’s U.S. healthcare cost posts, you know that this FEHB premium increase is in line with what other large employers are experiencing. As readers know, the 8.7% average increase assumes no one changes plans in Open Season. The FEHBlog thinks that OPM emphasizes this number to encourage federal employees and annuitants to shop for lower-priced coverage.

Here are the Federal News Network and Federal Times articles on this development.

From the Omicron and siblings front, here is the CDC’s weekly interpretative summary of its Covid statistics, which the FEHBlog continues to track.

As of September 28, 2022, the current 7-day moving average of daily new cases (47,112) decreased 13.1% compared with the previous 7-day moving average (54,202).

CDC Nowcast projections* for the week ending October 1, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five sublineages designated as Omicron: BA.5, BA.4.6, BF.7, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 81.3% (95% PI 79.6-83.0%).

The current 7-day daily average for September 21–27, 2022, was 3,733. This is a 7.4% decrease from the prior 7-day average (4,029) from September 14–20, 2022.

The current 7-day moving average of new deaths (344) decreased 6.7% compared with the previous 7-day moving average (368). 

As of September 28, 2022, 619.8 million vaccine doses have been administered in the United States. Overall, about 264.1 million people, or 79.5% of the total U.S. population, have received at least one dose of vaccine. About 225.3 million people, or 67.9% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 110.0 million people have received a booster dose,* and more than 7.5 million people have received an updated (bivalent) booster dose. But 49.8% of the total booster-eligible population has not yet received a booster dose. 

From Capitol Hill, Roll Call reports

The House cleared a temporary spending bill needed to avoid a partial government shutdown ahead of Friday night’s deadline, giving lawmakers a reprieve until after the midterm elections when they’ll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.

The measured passed on a 230-201, mostly party-line vote and will now be sent to President Joe Biden’s desk where he’s expected to sign it later on Friday. The Senate passed the measure Thursday, 72-25, after that chamber resolved some last-minute holds. 

The extension is through December 16, 2023.

Pension and Investments Online reports “More than 14 months after her nomination, the Senate on Thursday confirmed Lisa M. Gomez as assistant secretary of labor for the Employee Benefits Security Administration in a 49-36 vote.” EBSA is one of the Affordable Care Act and No Surprises Act regulators, which impacts FEHB. Good luck.

From the U.S. healthcare business front, Healthcare Dive informs us that the Justice Department has not appealed a September 19, 2022, federal district court rejecting the federal government’s challenge to United Healthcare’s acquisition of Change Healthcare.

[T]he DOJ could still appeal the UnitedHealth-Change ruling. Its earlier deal reached with UnitedHealth doesn’t prevent DOJ from appealing. 

“In any challenge to a merger, it is always beneficial for those challenging it to seek to have the merger enjoined before the matter actually closes,” Jim Burns, a partner at Williams Mullen and chair of its Antitrust and Trade Regulation Practice Group, told Healthcare Dive. 

But all signs indicate that the DOJ has decided not to appeal, a former government official with antitrust expertise told Healthcare Dive. 

To alleviate other antitrust concerns, UnitedHealth agreed to divest ClaimsXten to private equity group TPG Capital.

Tuesday’s Tidbits

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

From Capitol Hill, the Wall Street Journal reports

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

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

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

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

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

Today was filled with surprises.

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

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

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

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

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

From the benefit design front, Fierce Healthcare reports

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

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

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

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

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

From the studies/research department

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

From the tidbits department

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

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

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

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

 

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Govexec lays out what appears to be an unnecessarily complicated path to a continuing resolution funding the federal government for 10 weeks into the new federal fiscal year beginning October 1. The Senate majority leadership crafted the rocky path that stems from the compromise which lead to Congressional passage of the budget reconciliation act earlier this summer.

From the No Surprises Act front, the American Medical Association informs us

The AHA and American Medical Association today moved to dismiss their challenge to the federal government’s September 2021 interim final rule governing the No Surprises Act’s independent dispute resolution process.

The groups challenged the rule in a District of Columbia court last December, but the lawsuit became moot when the Administration released a revised final rule on Aug. 26. However, the AHA and AMA remain concerned that the final rule continues to favor insurers and does not line up with what Congress intended when it passed the law.

In a joint statement the AHA and AMA said, “No patient should fear receiving a surprise medical bill. That is why the AHA and AMA strongly supported the No Surprises Act to protect patients from unexpected medical bills and keep them out of the middle of any billing disputes between providers and commercial health insurance companies. Congress enacted the law with a balanced, patient-friendly approach, and it should be implemented that way. We have serious concerns that the August 2022 final rule departs from Congressional intent just as the September 2021 interim final rule did. Hospitals and doctors intend to make our voices heard in the courts very soon about these continued problems.”

The AHA and AMA’s suit did not seek to prevent the law’s core patient protections from moving forward. It sought only to force the Administration to bring the regulations in line with the law before the dispute negotiations begin.

The AHA / AMA lawsuit is consolidated with a suit filed by an air ambulance association which may explain why these two large provider associations are dismissing its case rather than amending their complaint. The FEHBlog does not understand why the provider associations refuse to give the new rule a chance before bringing another expensive lawsuit.

From the U.S. healthcare business front —

Fierce Healthcare reports

Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.

Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.

The transaction is expected to be completed by the end of the year. * * *

As a specialty pharmacy, Shields offers medications with unique handling, administration and monitoring requirements. Specialty drugs are used to treat complex or rare conditions such as cancer, hepatitis and transplants. Shields currently names 30 health systems as partners, including 1,000 hospitals.

and

Employer health startup Transcarent is making its next move with the launch of its new pharmacy program.

Transcarent’s Pharmacy Care offering is designed to be fully transparent and integrate with its other platforms. The goal, executives said, is to break through the noise for members and make it easier for them to understand their pharmacy benefits while offering employers full control over formulary, benefit design and data.

The platform is available to self-funded employers as well as health systems, Transcarent said in an announcement. Snezana Mahon, Transcarent’s chief operating officer, told Fierce Healthcare that the company’s employer clients have felt the market changes and are seeking a way to “coexist” in a world where there are traditional pharmacy benefits, cash pay and coupon cards all working together.

From the healthcare quality front, Beckers Hospital Review calls attention to

A new data visualizer shows the 10 most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists like those from U.S. News & World Report.

SimilarityIndex | Hospitals comes from Trilliant Health Labs, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 

Users can compare hospitals to find peers in either quality alone or aggregate — the latter reflects an equally weighted combination of measurements in the categories of hospital quality (including 30-day mortality and readmission rates), outpatient service line, financial (including operating margin and average inpatient service costs), patient mix and market share.

Nifty.

From the public health front —

The US Preventive Services Task Force (USPSTF) today posted for public comment draft recommendations on screening for anxiety, depression, and suicide risk in adults.

For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety — including pregnant and postpartum women.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.

The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.

The public comment deadline is October 17.

  • The Wall Street Journal offers advice on timing the annual flu shot and the upcoming flu season in general.
  • The CDC released a vital signs report warning that rates of screening and treatment of children with sickle cell anemia for life-threatening problems are far too low.

Two recommended healthcare measures to prevent complications in children with sickle cell anemia are:

* Transcranial doppler (TCD) ultrasound screening, which identifies children with increased risk for stroke.

* Hydroxyurea therapy, which reduces the occurrence of several complications, including severe acute pain episodes and acute chest syndrome, which can result in lung injury and trouble breathing.

Far too few patients are receiving these potentially lifesaving prevention measures, recommended by an expert panel in 2014. 

  • The CDC also called attention to its website about gestational diabetes.

From the Rx coverage front, Bio Pharma Dive relates

The Food and Drug Administration on Friday [September 16] granted accelerated approval to a personalized gene therapy for an ultra-rare childhood brain disease, called cerebral adrenoleukodystrophy or CALD.

Built from a patient’s own stem cells, the therapy is the first medicine to be made available in the U.S. for CALD, which affects young boys and typically results in severe disability or death. It was developed by the biotechnology company Bluebird bio and will be sold as Skysona.

Its approval is Bluebird’s second in four weeks, following an Aug. 17 FDA decision on another gene therapy from the company for the blood disorder beta thalassemia. * * *

In the U.S., an estimated 50 boys are born each year who will go on to develop CALD. Bluebird expects to treat about 10 annually.

Meant to be a one-time infusion, Skysona will cost $3 million. The price tag makes the therapy one of the most expensive ever launched on a single-use basis, exceeding the $2.8 million cost of Bluebird’s other gene therapy. * * *

Bluebird expects Skysona to be available by the end of the year, and is planning to work with a “limited number” of centers that are experienced in treating CALD and in stem cell transplantation, including Boston Children’s Hospital and CHOP [Children’s Hospital of Philadelphia].

[Due to the small number of patients, t]he company is not putting in place “outcomes-based” coverage agreements with insurers for Skysona as it did with its other gene therapy, for which it’s offering to reimburse part of the cost if patients don’t continue to benefit.

From the surveys department —

A majority of healthcare executives think value-based-care has replaced fee-for-service billing, a new survey found. 

Of 160 C-suite executives and other high-level staff surveyed, just 4 percent said they think payers use traditional fee-for-service billing with no connection to quality and value. The majority of executives think payers use FFS models with connections to the quality and value of care taken into account. 

The survey, conducted by business intelligence firm Morning Consult and health tech company Innovaccer, found just 1 percent of executives think FFS billing with no connection to value will be in use in 2025. 

According to a Sept.14 news release, payers report that FFS billing with no account for value makes up more than 10 percent of billing, higher than providers estimated. 

“So, providers think the transition to value has substantially occurred, when in fact we’re only at the very beginning,” Brian Silverstein, MD, Innovaccer’s chief population health officer, said in the release. “The amount of financial risk providers have is going to increase significantly in the next few years.”

  • Beckers Hospital Review tells us “Patients who are publicly insured or uninsured are more likely to be treated unfairly in healthcare settings compared to patients with private insurance, according to a report from the Urban Institute with support from the Robert Wood Johnson Foundation.”

In closing Federal News Network shares the list of deserving federal employees receiving the 2022 Partnership for Public Service’s Samuel J. Heyman Service to America Medals — affectionately known as the Sammies. These awards “often dubbed the “Oscars” of federal service” will be presented at a gala tonight. Hearty congratulations to the award winners and the other nominees.