Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From the No Surprises Act front, the FEHBlog nearly fell off his chair when he noticed this Healthcare Dive article:

The Department of Justice intends to appeal a federal judge’s ruling that sided with providers over a challenge to the surprise billing rule, according to a Friday filing from the DOJ in the Eastern District of Texas.  

The Texas Medical Association sued the federal government over its interpretation of the No Surprises Act, arguing the rule leans too heavily on one factor arbiters are supposed to consider when resolving payment disputes between payers and providers.      

Federal Judge Jeremy Kernodle’s February ruling said nothing in the bill passed by Congress instructs arbiters to “weigh any one factor … more heavily than the others,” indicating the rule conflicts with the bill.

The Justice Department noticed an appeal to the Fifth Circuit in the referenced Friday, April 22, filing with the District Court. That notice effectuates the appeal. The FEHBlog will keep an eye on the dockets to learn whether the Justice Department will seek a stay of the February ruling while the case is on appeal.

From the Omicron and siblings front —

  • Bloomberg’s Prognosis reviews progress being made in the development of Covid vaccines administered nasally. Nasal vaccines have a better shot at preventing COVID than injected vaccines.
  • The American Hospital Association reports “The Food and Drug Administration today expanded its approval for remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.”
  • Medical Dialogues informs us the World Health Organization has recommended Pfizer’s Paxlovid Covid pill over remdesvir, Merck’s pill and monoclonal antibodies for patients with milder forms of Covid and nevertheless at high risk of hospitalization from the disease, e.g. the elderly, the immunocompromised, and the unvaccinated.
  • WebMD News tells us “COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the CDC said Friday. * * * The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.”

The WebMD article offers other interesting public health nuggets. For example,

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the U.S. last year. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of .7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

From the healthcare business front, Fierce Healthcare reports

Change Healthcare has found a buyer for its payment integrity arm, ClaimsXten, though the sale is contingent on the closure of its merger with UnitedHealth Group.

According to a filing submitted Monday to the Securities and Exchange Commission, ClaimsXten will be sold off to an affiliate of TPG Capital for a base purchase price equal to $2.2 billion in cash. UnitedHealth is listed as the seller.

From the reports department —

  • The National Bureau of Economic Research offers a working paper titled “Pharmacy Benefit Managers and Vertical Relationships in Drug Supply: State of Current Research.”
  • Per HR Morning, “Employer support [of their workforces] is happening in the areas of increased prioritizing employee assistance programs (EAPs), expanded wellness benefits and greater attention to work/life balance. That’s according to Ragan’s 2022 Communications Benchmark Report that surveyed close to 1,000 communicators across industries on opportunities and changes.”
  • Per Health Payer Intelligence, Humana has produced an issue brief that provides “an overview of the policymaking landscape surrounding social determinants of health data collection.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

STAT News tells us

Scientists around the world are discovering and tracking newer forms of the Omicron coronavirus variant, showing how even when a strain becomes globally dominant, it continues to evolve and can splinter into different lineages.

Case in point: Updated data released Tuesday showed that a burgeoning form of Omicron, called BA.2.12.1 —  itself a sublineage of the BA.2 branch of Omicron — now accounts for nearly one in five infections in the United States. It’s eating into the prevalence of the ancestral BA.2, highlighting the emergent virus’s transmission advantage over its parent. BA.2 now accounts for about 74% of cases, while the remaining 6% or so are from the BA.1 branch of Omicron, the first form of the variant that took over globally and whose prevalence has been falling as BA.2 became dominant.

The menagerie can be dizzying to track, especially because all these cases technically fall under the Omicron umbrella. But even as scientists closely monitor the divergence of Omicron, early signs suggest the different lineages don’t substantially differ in terms of how virulent they are or in their ability to evade the protection generated by immunizations. While some of the newer forms of the virus might be better spreaders than others, their emergence doesn’t necessarily result in huge increases in cases.

David Leonhardt adds in his New York Times morning column today

In several places where the number of cases has risen in recent weeks, hospitalizations have stayed flat. (In past Covid waves, by contrast, hospitalizations began rising about a week after cases did.) * * *

Even if hospitalizations do rise in coming weeks, a declining share of coronavirus cases that result in serious illness would be very good news, Dr. Craig Spencer, director of global health in emergency medicine at Columbia University, has pointed out.

I haven’t seen a Covid patient in the E.R. in weeks and go to work now expecting not to,” Spencer told me, “despite a swirl of Covid in the community.”

Among other things, a decoupling of cases and severe illness would mean that hospitals were less likely to become overwhelmed during future Covid surges. When hospitals avoid getting swamped, they can provide care to every patient who needs it — which becomes another factor that reduces bad health outcomes.

For these reasons, Mr. Leonhardt plans to shift his focus from new cases to new hospitalizations.

From the Covid vaccine front

Govexec explains

Because mRNA-based vaccines are a relatively new class of vaccines, they do not include the traditional adjuvants. The current mRNA vaccines used in the U.S. rely on small balls of fat called lipid nanoparticles to deliver the mRNA. These lipid molecules can act as adjuvants, but how precisely these molecules affect the long-term immune response remains to be seen. And whether the current COVID-19 vaccines’ failure to trigger strong long-lived antibody response is related to the adjuvants in the existing formulations remains to be explored.

While the current vaccines are highly effective in preventing severe disease, the next phase of vaccine development will need to focus on how to trigger a long-lived antibody response that would last for at least a year, making it likely that COVID-19 vaccines will become an annual shot.

STAT News adds

New data from Moderna offer hope that booster shots against Covid-19 could become at least somewhat more effective than they already are. But the data also point to how difficult it could be to determine exactly which Covid shots to give as annual boosters.

At a hearing of a Food and Drug Administration advisory panel earlier this month, experts fretted about exactly how governments should make decisions about the composition of annual boosters. And they were adamant that governments, not pharmaceutical companies, should be deciding the strain composition of the shots, as the World Health Organization does for influenza shots. But these data are a reminder that those decisions can be tough. What would experts do when faced with booster shots with several different compositions? Will adding new strains work similarly for different types of vaccines? There are a huge number of open questions.

There’s also the biggest problem with annual flu shots: People don’t get them. Even with the current Covid boosters, this has been true. Data presented to the FDA panel said that 217 million Americans are vaccinated about Covid. But only 90 million people have received a booster dose. How many will turn out for a new booster next year?

Look at this comparison of winter 2019-2020 flu vs. 2020-2021 Covid

2019 – 2020 Winter CDC Fluview 3/28/202020-2021 Winter COVID-1910/1/2020 to 3/21/2021
Flu Deaths                       24,000 COVID-19 Deaths               332,636 
Flu Cases             39,000,000 COVID-19 cases        22,399,598 
Deaths over total cases0.06%1.49%
https://www.cdc.gov/flu/weekly/index.htm

Who would look back on pre-Covid flu as the good old days? But comparatively, it is. We see millions more flu cases, but hundreds of thousands fewer flu deaths.

Kaiser Health News discusses the need for better ventilation in office buildings which could help tamp down Covid and flu cases. “The science is airtight,” said Joseph Allen, director of the Healthy Buildings program at Harvard University’s T.H. Chan School of Public Health. “The evidence is overwhelming.”

From the No Surprises Act front, Healthcare Dive reports

The online portal for resolving payment disputes between payers and providers for certain out-of-network charges is now open, the CMS said Monday. The portal initiates what’s known as the federal independent dispute resolution process, a key part of the No Surprises Act that outlaws balance bills in most cases. As a last resort, it allows payers and providers to resolve payment disputes using an arbitration style similar to the model adopted by Major League Baseball in salary negotiations.

From the transparency in coverage rule front, the Labor Department issued ACA FAQ 53 today. FAQ 53 provides guidance to health plans, including FEHB plans, on how to post three machine-readable pricing files on their website. The Labor Department will begin to enforce this requirement on July 1, 2022.

From the healthcare pricing front

Health Affairs reports

Commercial health plans pay higher prices than public payers for hospital care, which accounts for more than 5 percent of US gross domestic product. Crafting effective policy responses requires monitoring trends and identifying sources of variation. Relying on data from the Healthcare Provider Cost Reporting Information System, we describe how commercial hospital payment rates changed relative to Medicare rates during 2012–19 and how trends differed by hospital referral region (HRR). We found that average commercial-to-Medicare price ratios were relatively stable, but trends varied substantially across HRRs. Among HRRs with high price ratios in 2012, ratios increased by 38 percentage points in regions in the top quartile of growth and decreased by 38 percentage points in regions in the bottom quartile. Our findings suggest that restraining the growth rate of HRR commercial hospital price ratios to the national average during our sample period would have reduced aggregate spending by $39 billion in 2019.

Fierce Healthcare relates

Seniors save nearly $2,000 on average a year in total healthcare spending in Medicare Advantage (MA) compared to fee-for-service Medicare, a new study finds.

The study, published Tuesday, by the advocacy group Better Medicare Alliance finds that seniors spent $1,965 less including premiums and out-of-pocket costs on MA when compared to fee-for-service.

“We see particularly strong results for historically disadvantaged populations, including Black and Hispanic beneficiaries and those who are low-income,” said Allison Rizer, principal at the consulting firm ATI Advisory, which performed the study that examined 2019 Medicare Current Beneficiary Survey data.

From the healthcare business front, Fierce Healthcare tells us

UnitedHealth Group executives said Thursday that its Optum Health subsidiary, which is one of the country’s largest physician groups, is building out value-based care partnerships at a faster rate than was expected.

In its earnings report, the healthcare giant said it initially projected that 500,000 new patients would be treated in value-based arrangements. It’s upping that projection to 600,000. Wyatt Decker, M.D., CEO of Optum Health, said on the company’s earnings call that reflects Optum’s efforts to invest in technology, analytics and building networks are paying off.

“What you’re really seeing is a result of almost 10 years of building a flywheel that now has significant momentum,” Decker said. “All of that continues to yield benefits and, frankly, growth.”

From the research front —

MedPage Today announced

The severity of multiple sclerosis (MS) was linked with geographic latitude, an observational study showed.

Among 46,000 MS patients living in temperate zones, more severe disease was seen in those who lived above 40° latitude, reported Tomas Kalincik, MD, PhD, of the University of Melbourne, Australia, and co-authors.

The association was driven mainly, but not exclusively, by ultraviolet B (UVB) radiation exposure contributing to both MS susceptibility and severity, the researchers wrote in Neurology.

AHRQ discusses a study on “Geographic Variation in Inpatient Stays for Five Leading Substance Use Disorders, 2016-2018.” There are interesting State variations.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the month, here are the FEHBlog’s weekly charts of new Covid cases and deaths

Here is a link to the CDC’s weekly review of COVID statistics. Among those statistics are the following:

New Hospital Admissions

The current 7-day daily average for April 6–April 12, 2022, was 1,446. This is a 1.3% increase from the prior 7-day average (1,427) from March 29–April 4, 2022.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era to the latest week ending last Wednesday, April 13.

For the second week in a row, Covid vaccines distributed and administered have increased materially.

The CDC’s principal point in this week’s Covid statistical review is the following:

Throughout the COVID-19 pandemic, many people have delayed or avoided medical care, including routine, urgent, and emergency care. If it’s something you’ve neglected, it’s time to jump back in—consider putting “get a checkup” on top of your to-do list, especially if you’re at risk for heart disease. Regular checkups provide the opportunity to prevent, screen for, and manage chronic conditions, and to get routine vaccinations.

The FEHBlog agrees that the best step a person can make on the road to a healthy life is to establish a relationship with a primary care doctor.

In other Omicron and siblings news —

MedPage Today informs us

The FDA granted an emergency use authorization (EUA) to the first COVID-19 test that can detect the virus in breath samples, the agency announced on Thursday.

Dubbed the InspectIR COVID-19 Breathalyzer, the test uses gas chromatography-mass spectrometry to rapidly detect volatile organic compounds associated with SARS-CoV-2. Patients breathe into a disposable straw on the device — which is about the size of a piece of carry-on luggage, according to the agency — and results are returned in less than 3 minutes. The test is intended for healthcare settings where samples can be collected and analyzed, such as mobile testing sites, doctor’s offices, and hospitals.

Cool.

Kaiser Health News tells us

The federal “test-to-treat” program, announced in March, is meant to reduce covid hospitalizations and deaths by quickly getting antiviral pills to people who test positive. But even as cases rise again, many Americans don’t have access to the program.

The program allows people with covid symptoms to get tested, be prescribed antiviral pills, and fill the prescription all in one visit. The federal government and many state and local health departments direct residents to an online national map where people can find test-to-treat sites and other pharmacies where they can fill prescriptions.

But large swaths of the country had no test-to-treat pharmacies or health centers listed as of April 14. * * *

Even people who regularly see a doctor may be unable to get a prescription in time, and that’s where the program comes in. Before the pandemic, 28% of Americans didn’t have a regular source of medical care, with rates even higher for Black and Hispanic Americans. 

See above re PCPS and no bueno.

The article adds

Truepill, a company that provides telehealth and pharmacy technology, offers online covid assessments through its website findcovidcare.com * * *. The company has filled more than 10 million prescriptions in the past five years.

The service, available in all 50 states and Washington, D.C., costs $25 to $55. Though insurance isn’t accepted, the cost is comparable to insurance copays for in-person doctor appointments. Prescriptions can be sent to a local pharmacy for no additional charge or shipped to a home overnight via FedEx for a $20 fee.

It’s always good to have a Plan B.

From the FEHB front, OPM issued a final, final rule concerning a Consolidated Appropriations Act 2021 provision extending the opportunity for tribal employers to enroll employees at certain tribal schools to join the FEHB Program.

From the Social Determinants of Health Front, Fierce Healthcare calls to our attention

a Northeast Business Group on Health guide for employers looking to tackle obesity and diabetes through a racial lens. “Obesity, Diabetes and Health Equity: What Employers Can Do” lays out a step-by-step approach. Key among them is embedding health outcomes within other diversity, equity and inclusion efforts. Another big recommendation is to build benefits to address obesity and diabetes that are based in clinical best practices.

In the FEHBlog’s view, OPM’s 2023 call letter asks carriers to address member obesity issues in this manner.

From the Rx coverage front, the Wall Street Journal reports

After Covid-19, vaccine makers’ next big target is a respiratory virus that kills up to 500 children a year nationwide and has been among the leading causes of U.S. hospitalizations for decades.

The respiratory syncytial virus, or RSV, infects nearly everyone at some point, causing mild, cold-like symptoms for most people. But it can lead to serious health problems such as difficulty breathing and pneumonia for infants and older adults.

Now several drugmakers including Pfizer Inc., Johnson & JohnsonModerna Inc. and GlaxoSmithKline PLC are testing shots that infectious-disease specialists say show promise at safely preventing RSV disease. Initial development of most of these vaccines predated the current pandemic, but the rapid success in finding effective Covid-19 vaccines has energized the RSV effort, according to analysts.

Good luck.

From the federal government front

  • Meritalk provides a Who’s Who in implementing the President’s Management Agenda. The article explains “As the Office of Management and Budget’s (OMB) effort to transform the President’s Management Agenda from a list of goals into actionable policy steps gathers steam, OMB is fleshing out its list of Federal agency officials who are taking on leadership roles not only for the three major PMA pushes but for numerous strategic goals within each of them.” The OPM Director Kiran Ajuha is one of three senior federal executives in charge of the PMA’s workforce issues.
  • Federal News Network offers an interview with the Postmaster General Louis Dejoy.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Omnicron and siblings front, the Wall Street Journal reports encouraging news.

The Omicron BA.2 variant has dominated new infections in the U.S. for weeks without setting off a major surge so far, raising hopes among some public-health experts that the nation might dodge a more significant hit.

BA.2 is in particular affecting the Northeast, where virus concentrations in wastewater are rising alongside reported infections in such places as New York, Washington, D.C., and Philadelphia. Concern about BA.2 prompted Philadelphia to restore an indoor-mask requirement and U.S. authorities to extend mask mandates for airplanes and other forms of transportation.

Still, BA.2 hasn’t yet caused the rise in hospitalizations some doctors said they would have anticipated. Disease experts say some combination of immunity from Covid-19 vaccinations and a severe wintertime surge, aided by springtime weather drawing people outdoors, might be keeping the virus at bay.

MedPage Today informs us

A booster dose of the Pfizer-BioNTech COVID-19 vaccine was safe and produced an immune response in kids ages 5 to 11, including against the Omicron variant, the companies said on Thursday.

These data came from two sources: the phase II/III clinical trial on 140 children ages 5 to 11 who received a booster dose at least 6 months after their two-dose primary series, and a subgroup of 30 kids in whom response against Omicron was studied specifically. In this subgroup analysis, there was a 36-fold increase in neutralizing antibody titers compared with levels seen after the two-dose primary series, the companies reported.

The companies plan to submit a request to the FDA for an emergency use authorization (EUA) for a third dose for this age group “in the coming days.” The agency previously authorized a two-dose primary series of the 10 μg formula for this age group in October 2021.

Health IT Analytics tells us, “When comparing groups that experienced the worst effects of COVID-19, a study published in Public Health Nursing found that the pandemic had a significant impact on those who exhibit high social vulnerability, leading them to have the highest mortality levels.” This finding illustrates the importance of resolving health disparities.

On a related note, Govexec reports

More than 90 federal agencies released their first-ever equity action plans on Thursday, laying out more than 300 strategies to better help underserved communities. This follows an executive order President Biden issued on day one of his administration, which directed agencies to conduct equity assessments of their top three to five high-impact services for Americans to determine where there were systematic barriers. These findings helped agencies develop their plans.

“Taken together these 300 actions demonstrate what it means to take a whole-of-government approach to advancing equity,” said a senior administration official on a background briefing call. “For the first time Americans will see a full picture of what it looks like for the entire federal government to advance equity at once.”

For example, Health and Human Services Department plans to better help individuals with limited English proficiency access federal health programs; the General Services Administration seeks to assess the impact on communities of its vast real estate portfolio; and the Office of Personnel Management looks to invest in data to look at potential barriers in the federal hiring process.

In a significant development from the No Surprises Act front, the Affordable Care Act regulators issued helpful Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties and Certified IDR Entities. The new guidance no longer treats the Qualifying Payment Amount as a rebuttable presumption. This action strongly suggests that the QPA’s rebuttable presumption status will be removed from the “final, final” version of the IDR rule. That regulation is due out next month. However, the rule does not yet appear on the OMB Office of Information and Regulatory Affairs’ list of rules currently being subjected to their oversight.

In other regulatory news, the International Foundation of Employee Benefits Plans alerts us, ​

The Department of Justice (DOJ) released guidance including frequently asked questions (FAQs) on how the Americans with Disabilities Act (ADA) protects individuals from discrimination when they are being treated for and recovering from opioid use disorder (OUD).

From Capitol Hill, EndPoint News reports

A group of 30 bipartisan lawmakers sent letters to 7 naloxone manufacturers, calling on them to apply for over-the-counter status for their opioid overdose antidotes and open up supplies further as the opioid crisis continues in the US with record levels of overdoses and deaths.

Citing a Massachusetts study that found substantially increased access to naloxone reduced opioid overdose mortality rates by 46%, the senators and representatives called on Pfizer, Teva Pharmaceuticals, Adamis Pharmaceuticals, Akorn, Amphastar Pharmaceuticals, Emergent BioSolutions, and Hikma Pharmaceuticals to “submit applications to make naloxone available over the counter without delay.”

Currently, there are three FDA-approved forms of naloxone — injectable, auto-injector and nasal spray — and all three currently require a prescription, but in most states and the District of Columbia pharmacists are allowed to dispense naloxone under a standing order, meaning they don’t actually need individual prescriptions. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers.

Good idea. The HHS Secretary Xavier Becerra extended the opioid epidemic public health emergency for another 90 days earlier this month.

From the healthcare business front, Healthcare Dive reports on UnitedHealth Group’s 1st Quarter 2022 financial results.

UnitedHealth is bullish on completing its controversial acquisition of data analytics firm Change Healthcare, despite legal action from the Department of Justice to block the deal.

UnitedHealth’s extended agreement with Change “reflects our firm belief in the potential benefits of this combination to improve healthcare and in our ability to successfully overcome the challenge to this merger,” Chief Operating Officer Dirk McMahon told investors on a Thursday morning call regarding first-quarter financial results.

The Minnetonka, Minnesota-based healthcare behemoth beat Wall Street expectations for earnings and revenue in the quarter, with a topline of $80.1 billion, up 14% year over year due to double-digit growth at health services arm Optum and payer business UnitedHealthcare. Net earnings were $5.1 billion, up 3% year over year. UnitedHealth raised its full-year guidance following the results.

STAT News adds

The Omicron surge didn’t lead to an explosion of medical claims at UnitedHealth Group, which contributed to higher-than-expect profits. UnitedHealth ended the first three months of the year with more than $5 billion of profit on $80.1 billion of revenue. The company’s medical loss ratio, which shows the percentage of insurance premiums that were spent on medical claims, was 82% — higher than 80.9% in the first quarter of 2021, but less than what Wall Street expected.

From the miscellany department

  • The ICD 10 Monitor discusses “two extremely encouraging studies in terms of the content coverage and feasibility of replacing ICD-10-CM with ICD-11.”
  • BioPharma Dive reports “AbbVie and Genmab said treatment with their dual-acting antibody epcoritamab led to responses in nearly two-thirds of patients with lymphoma, announcing on Wednesday that their clinical trialsurpassed its benchmark for success. The partners will now take the data to the Food and Drug Administration and other regulators to determine whether it’s good enough to formally submit for approval.”
  • Health Data Management offers useful insights into the ongoing TEFCA launch.

Midweek Update

Photo by Thought Catalog on Unsplash

From the Omicron and siblings front —

The Secretary of Health and Human Services Xavier Becerra renewed the declaration of a public health emergency due to Covid for another 90 days from April 16. Roll Call provides background on this expected decision.

Beckers Hospital Review summarizes an interview the White House’s new COVID-19 response coordinator, Ashish Jha, MD, recently gave to NPR. The article describes Dr. Jha as optimistic.

Roll Call also offers its perspectives on the CDC’s Covid vaccination strategy.

Some experts question boosting with vaccines modeled on the original virus as new variants sweep the globe. The immune system responds most quickly to variants it has already encountered, and evidence has shown that people infected with a significantly different variant of a virus can potentially suffer worse reactions when a new wave hits. 

But it’s not yet clear if this is the case with COVID-19 or whether the current vaccines have broad enough protection to neutralize this phenomenon, known as “original antigenic sin.” 

“Theoretically, repeated exposure to an older variant formula may drive our immune system to concentrate too much on old features and not on new features,” Katelyn Jetelina, an assistant professor at University of Texas Health Science Center, wrote in her Substack newsletter. “But despite some truly surprising evolutionary leaps of the virus (like Omicron) we have not seen any convincing evidence of OAS among humans, which is great news.”

There’s also disagreement in the medical community about whether more COVID-19 shots of any kind are necessary for the broader public beyond the elderly and high-risk. The debate has muddled the message on already confusing booster recommendations.

“The FDA and CDC have kind of come out with, like, a lukewarm, ‘Yeah, you can do this,’ as opposed to, ‘Run and do it now.’ And you know, that’s going to leave most people confused,” said Jen Kates, Kaiser Family Foundation director of global health and HIV policy. 

In this regard, the Wall Street Journal discusses “Why It Is Hard to Know Who Needs a Covid Booster: Mysterious T Cells: Vaccine experts aren’t certain who under 65 years should get a second booster–and when–because the response of T cells is poorly understood.”

Researchers and U.S. health officials measuring whether Covid-19 vaccines work have largely focused on the body’s first-line defense, called antibodies. The Food and Drug Administration recently cleared a second booster shot partly based on real-world research out of Israel showing the extra dose restored antibody levels that had waned and reduced risk of infections.

“You have T cells that are not waning to the same degree and are likely a big part of what’s going to keep you out of the hospital,” said John Wherry, director of the Institute for Immunology at the University of Pennsylvania.

The presence of T cells, vaccine experts say, might explain why many vaccinated people who tested positive for Covid-19 several months after their inoculations managed to avoid severe cases.

The T cells continue to work against the virus, according to the experts and studies, after antibodies have waned or lost effectiveness because of a variant. 

Some studies have found that T cells from Covid-19 shots persist for at least half a year after initial series of vaccination. A study by researchers at La Jolla Institute and published in the journal Cell in March found that the T cells lasted six months and were about 80% as effective against Omicron as other variants. 

Lingering T cells might reduce the need for many healthy people to get a second booster dose within months of their first, some vaccine experts say. In fact, there might be diminishing returns from getting boosters over time if T-cell levels eventually plateau or slowly drop over time as people get more shots, researchers say.

There is limited evidence to go on, however. * * * Dr. Wherry said his lab expects to publish data soon showing that T cells after the initial series of vaccines remain in the body for at least nine to 12 months. “We are building the plane as we’re flying,” Dr. Wherry said. 

From the Covid vaccine mandate for federal employees front, Govexec follows up on last week’s decision from the U.S. Court of Appeals for the Fifth Circuit lifting the preliminary injunction on that mandate. The FEHBlog noted earlier this week that the federal government has asked the Fifth Circuit to accelerate the effective date for that action. Govexec tells us that the plaintiffs’ attorneys have opposed the government’s motion and intend to petition the Court for a rehearing or a rehearing en banc.

The White House announced “Additional Actions in Response to Vice President Harris’s Call to Action on Maternal Health.” Of interest to FEHB carriers, the fact sheet explains

  • “Birthing-Friendly” Hospital Designation: CMS is proposing the “Birthing-Friendly” hospital designation to drive improvements in maternal health outcomes and maternal health equity. The “Birthing-Friendly” hospital designation would assist consumers in choosing hospitals that have demonstrated a commitment to maternal health. The Administration announced this new designation during the White House Maternal Health Day of Action Summit.
    • Initially, the designation would be awarded to hospitals based on attestation that the hospital has participated in maternity care quality improvement collaboratives and implemented best practices that advance health care quality, safety, and equity for pregnant and post-partum patients.
    • Data will be submitted by hospitals for the first time in May 2022, and CMS will post data for October to December 2021 in fall 2022. Criteria for the designation may be expanded in the future.

OPM’s call letter for 2023 benefit and rate proposals suggested that carriers keep an eye on this initiative.

Speaking of government initiatives, Federal News Network brings us up to date on the TEFCA initiative that would create a backbone for the country’s regional health data networks, among other data resources.

From the government reporting front, HR Dive informs us

The U.S. Equal Employment Opportunity Commission today opened 2021 data collection reporting for its Employment Information Report (EEO-1), Standard Form 100, Component 1. The filing deadline is May 17, 2022, EEOC said.

Generally, private employers with at least 100 employees must submit an EEO-1 Component 1 report. So must federal contractors with 50 or more employees. 

The window for reporting has been shortened significantly compared to the last two years, with HR given a little over one month to complete the form.

Gee, the FEHBlog understood that the Covid public health emergency had been extended.

From the medical research from LifeSciences Intelligence reports

A major international study recently identified 75 genes associated with an increased risk of developing Alzheimer’s disease, including 42 new genes not previously discovered. 

The study involving UK Dementia Research Institute researchers enrolled over 100,000 individuals with Alzheimer’s disease and over 600,000 healthy individuals across the UK, US, Australia, and Europe. Researchers studied the differences in their genetic makeup. 

Notably, 60–80% of disease risk is based on genetics. Therefore, researchers must continue to uncover the biological causes and develop treatments for the millions of people affected globally.  

From the mental healthcare front, Beckers Hospital Review offers a suicide rate of each U.S. state and the District of Columbia in 2020, according to a ranking Kaiser Family Foundation released on April 12. The national age-adjusted suicide rate was 13.5 per 100,000 people in 2020. Wyoming had the highest rate and the District of Columbia the lowest.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill —

Roll Call informs us

The House Appropriations Committee is tentatively planning to take up its fiscal 2023 spending bills in June, teeing up potential floor votes in July, according to people familiar with the schedule.

Subcommittees would mark up their 12 annual bills from June 13 to June 22. The full committee would hold its markups from June 22 through June 30.

The top four appropriators in the House and Senate, known as the “four corners,” are expected to meet shortly after the two-week recess this month to begin discussions aimed at reaching a bipartisan agreement on overall discretionary spending levels for the fiscal year that begins Oct. 1.

STAT News tells us

A bipartisan group of four key lawmakers unveiled a long-shot policy that aims to alleviate one of the American health care industry’s most embarrassing problems: mind-bogglingly high prices for insulin, a drug millions of Americans need to survive.

The policy outline released Monday is a reboot of a three-year-old bill introduced by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). It would dangle a carrot for drugmakers to lower their list prices. Insurers and middlemen wouldn’t get to keep fees for diabetes drugs — but only if drugmakers lower list prices for drugs back to 2006 levels. It would also make sure patients with Medicare or private insurance don’t pay more than $35 per month for their insulin, though it would not offer the same protection to the uninsured.

Federal News Radio follows up on last week’s Senate confirmation of Kristin Boyd to be the first Senate-confirmed OPM Inspector General in over six years.

From the Omicron and siblings front —

Fierce Healthcare calls attention to a Commonwealth Fund report on the efficacy of Covid vaccines

COVID-19 vaccinations have blunted the worst waves of the pandemic, preventing millions of deaths, limiting strain on the U.S. healthcare system and producing “substantial cost savings” in healthcare spending, according to new estimates published Friday by the Commonwealth Fund.

From the first authorizations in December 2020 through March 2022, COVID-19 vaccination was estimated to have averted roughly 2.3 million deaths and 66.2 million additional infections, per the analysis.

Further, the push for shots in arms was found to have prevented 17 million hospitalizations in the U.S. and saved the country’s healthcare system just shy of $900 million in total spending, notwithstanding the country’s savings related to workplace absences and deaths.

The Wall Street Journal reports

The risk of developing inflammatory heart conditions after Covid-19 vaccination is relatively low, two large studies found, especially when compared with the heart-related risks from Covid-19 disease itself and from vaccines against other diseases [such as the flu].

“The overall message is that you can never consider risk in isolation,” said Jason Perry Block, an associate professor at Harvard Medical School and a co-author of the CDC’s analysis.

Concerns over potential side effects from Covid-19 vaccines are one reason some eligible adults in the U.S. say they haven’t gotten the shots, according to public-opinion surveys. About 70% of eligible Americans have been fully vaccinated against Covid-19, according to the CDC.

In considering the cardiac risks associated with Covid-19 vaccines, Dr. Block said people “also have to consider the risk on the other hand. If you don’t get vaccinated and do get infected, the risk is higher of cardiac complications.”

From the Covid vaccine mandate front —

A federal district court in Georgia preliminarily enjoined the federal government’s vaccine mandate on its contractors. The federal government appealed to the U.S. Court of Appeals for the 11th Circuit. The appeal was argued before a panel of three judges last Friday. Federal News Network adds

A three-judge panel from the U.S. Court of Appeals for the 11th Circuit says it remains unclear whether the Biden administration has the authority to impose a COVID-19 vaccine mandate on federal contractor employees.

The administration told the court last Friday that federal contracting law gives the president broad authority to set the terms of the federal government’s contracts, including making sure contractors have enough healthy employees to complete their contracts with agencies on time.

The judges,  however, repeatedly said during oral arguments that the federal government has a high bar to clear, in order for the court to overturn a lower court’s injunction barring the administration from enforcing the mandate.

The 11th Circuit likely will issue its opinion next month.

The Hill reports on the latest developments in the federal government’s vaccine mandate on its workforce.

The Biden administration on Monday asked a federal appeals court to clear a procedural hurdle that remained after a key legal victory last week and allow the administration to quickly resume enforcement of its COVID-19 vaccine mandate for federal employees.  

The request to the U.S. Court of Appeals for the 5th Circuit, if granted, would effectively reinstate the public health policy after it was put on hold across the country in January by a federal judge in Texas.

* * *

The administration’s request Monday would move up the timeline for the panel’s judgment to take effect, which is currently not set to occur until May 31. 

From the SDOH front, Health Payer Intelligence informs us

UnitedHealthcare announced that it will expand a program to advance maternal health equity in for minority communities in North Carolina.

“Access to quality maternal health care will help close the gap on health inequity in our state,” said Anita Bachmann, chief executive officer of UnitedHealthcare Community Plan of North Carolina. “We are honored to partner with Mountain Area Health Education Center and SistasCaring4Sistas of North Carolina to address disparities and outcomes with the expanded doula program.”

The payer partnered with the community-based organization SistasCaring4Sistas to expand access to the organization’s program, Doulas for Social Justice.

From the Aduhelm front, Fierce Healthcare reports on payers’ cheerful reaction to last week’s CMS Medicare coverage decision of that expensive drug only at the clinical trial level. “We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP.”

From the miscellany department

  • The Wall Street Journal reports about “New apps and telehealth services [that] are providing women in middle age more access to health expertise, education and support to help them during menopause [such as MenoLife].”
  • The Department of Health and Human Services shares Secretary Becerra’s remarks at the White House Medical Debt Event with Vice President Harris. Here is a link to the Administration’s fact sheet describing new actions to lessen the burden of medical debt and increase consumer protection. According to the fact sheet,

These actions will help:

Hold medical providers and debt collectors accountable for harmful practices;

Reduce the role that medical debt plays in determining whether Americans can access credit – which will open up new opportunities for people with medical debt to buy a home or get a small business loan;

Help over half a million of low-income American veterans get their medical debt forgiven; and,

Inform consumers of their rights.

  • Medpage offers an interesting account of how a doctor is trying to make sure that his patients get the medical screening tests that they need.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using 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, a low points of cases and death, and the 14th week of 2022, another lull but not quite as low.

The CDC’s Weekly Review of its COVID statistics issued today notes “The current 7-day daily average for March 30–April 5, 2022, was 1,406. This is a 10.3% decrease from the prior 7-day average (1,567) from March 23–29, 2022.”

Here’s the FEHBlog’s weekly chart of Covid vaccinations administered and distributed since the beginning of the Covid vaccination era through this week, again using Thursday as the first day of the week.

The administration of Covid vaccines popped us this week. Over 75% of the U.S. population aged 18 and older are fully vaccinated. Nearly half (48.6%) of that cadre is boostered. The Weekly Review’s commentary discusses the importance of vaccinating children.

COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history, and adverse events are rare. Vaccinating children is the single best way to protect them from severe illness associated with COVID-19. 

From Capitol Hill, the Wall Street Journal reports

Senators had also hoped to move forward on the coronavirus vaccines and treatments package, but progress quickly bogged down over Republican efforts to amend the bill to extend a pandemic-era immigration policy called Title 42—which allows Border Patrol agents to quickly turn away migrants at the southern border—with some Democrats siding with the GOP. Senators said they ran out of time, and the break could help end the logjam, even if it means the aid will need to wait at least several weeks.

“We’ll see where the discussions go, but my assumption is during the course of the break they’ll be some conversations between people who are interested in advancing it and see if we can make any headway on coming up with a process,” said Sen. John Thune (R., S.D.) on the Covid aid.

“I don’t think we’re leaving anything hanging up in the air that we’re not going to be able to continue to work with afterwards,” said Sen. Angus King (I., Maine), who caucuses with Democrats.

Congress is on State / District work periods for the next two weeks.

From the Rx coverage front, Health Affairs offers a fascinating article leading with an HHS Inspector General report on biosimilar drug use in the Medicare Part D program. The article blossoms into a broader look at biosimilar use in America. For example,

Last fall, two academics from the USC Schaeffer Center for Health Policy & Economics and the University of Chicago Harris School of Public Policy analyzed the available biosimiliars and found these were, on average, 30% less expensive than the underlying brand-name biologics. This represented a savings of about $665 off the average price.

Perhaps the biggest boost, though, will occur when biosimilar versions of Humira begin entering the U.S. market next year. This is expected to kick-start a wave of increased biosimilar usage between now and 2027, by which time the worldwide market should roughly double to $20 billion, according to Bernstein analyst Ronny Gal.

“The savings we identified with increased biosimilar use, while modest, could be significant once biosimiliar versions of Humira come on the market,” said [Melissa] Baker [from the HHS Office of Inspector Genera]. “Part D spending for Humira is in the billions of dollars.” The HHS OIG report noted that Humira and Enbrel accounted for more than $5 billion in Part D spending and nearly half of Part D spending on biologics in 2019.

From the Aduhelm front, Fierce Healthcare tells us

Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.

FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.

“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.

From the mental healthcare front, Health Payer Intelligence informs us

CVS Health and its payer arm, Aetna, aimed to make strides in the healthcare industry in 2021 by delivering affordable healthcare services to members, increasing access to virtual and mental healthcare, and implementing initiatives to advance health equity, according to the payer’s 2021 Environmental, Social, and Governance (ESG) report. The report reflects data from January 1 to December 31, 2021.

Well done.

Finally, the FEHBlog ran across this helpful Kaiser Family Foundation preventive services tracker website.

The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services.  As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.

This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.

For more information, see the fact sheet Preventive Services Covered by Private Health Plans under the Affordable Care Act.

This tracker also applies to FEHB plans. Thanks, KFF.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Capitol Hill front, today, the Senate took the following action

PN1166: Krista Anne Boyd, of Florida, to be Inspector General, Office of Personnel Management– Considered by Senate.– Confirmed by the Senate by Voice Vote.

And just like that, OPM has a Senate-confirmed Inspector General for the first time in over six years. The FEHBlog wishes Inspector General Boyd good luck.

The President issued a statement on World Health Day, which was celebrated today.

From the Omicron and siblings front —

  • The Centers for Medicare Services released an updated Toolkit on Covid Vaccines for health insurers and Medicare Advantage plans.

A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.

The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand. 

From the Rx coverage front —

STAT News reports

Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.

The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.

The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.

But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.

They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.

Here is a link to the CMS fact sheet on this decision.

U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.

From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.

From the healthcare business front, Fierce Healthcare informs us

[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.

At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.

The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”

In sad news, the Wall Street Journal reports

Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.

Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.

St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.

Centene offers FEHB HMO coverage through its Health Net subsidiary. RIP.

Midweek update

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Friday Stats and More

Based on the Centers for Disease Control’s Covid data tracker and using Thursday as the first day of the week, here are the FEHBlog weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 13th week of 2022:

The CDC weekly review of its Covid data adds

Currently, there are 19 (0.59%) counties with a high COVID-19 Community Level, 146 (4.53%) counties with a medium Community Level, and 3,059 (94.88%) counties with a low Community Level. This represents a slight (−0.84%) decrease in the number of high-level counties, a moderate (−2.73%) decrease in the number of medium-level counties, and a corresponding (+3.57%) increase in the number of low-level counties. Twenty-seven (48.21%) of 56 jurisdictions had no high- or medium-level counties this week. To check your COVID-19 community level, visit COVID Data Tracker.

* * *

The current 7-day daily average [of new Covid hospital admissions] for March 23–29, 2022, was 1,564. This is a 15.8% decrease from the prior 7-day average (1,858) from March 16–22, 2022. * * *

The current 7-day moving average of new [Covid] deaths (627) has decreased 14.4% compared with the previous 7-day moving average (732).

Here’s a link to the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the beginning of the Covid vaccination era until last Wednesday.

The CDC’s weekly review notes

As of March 30, 2022, the 7-day average number of adhttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlministered vaccine doses reported (by date of CDC report) to CDC per day was 214,405, a 17.8% increase from the previous week.

CDC’s COVID Data Tracker displays vaccination trends by age group, race/ethnicity, and urban/rural status. To see trends by age group and race/ethnicity, visit the Vaccination Demographic Trends tab. To see trends by urban/rural status, visit the COVID-19 Vaccination Equity tab.

The American Medical Association offers guidance to physicians concerning the FDA’s emergency authorization of a second Covid booster for Americans aged 50 and older.

HR Dive discusses what employers should take away from the Biden Administration’s updated approach to Omicron.

Here’s a link to the CDC’s weekly flu surveillance report or Fluview.

From the “and more” department —

  • HR Dive discusses what employers can do to help employees with adolescent children suffering from behavioral health issues. For example, because a shortage of child psychiatrists exists,

Telemental health programs offer convenient access (often at lower cost than in-person care) for many services—and some, like Brightline, are designed specifically for families of children with mental health needs. However, recent studies have shown that telehealth offerings are not being utilized as much for children as they are for adults, for rural populations as they are for urban ones, or for low-income communities as they are for wealthier ones. Clearly, there is an opportunity for employers to make vulnerable populations aware of the telemental health services available to them. 

  • BioPharma Dive identifies “Five FDA decisions to watch in the second quarter. Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.”