Thanksgiving Weekend Update

Thanksgiving Weekend Update

Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate return to Capitol Hill for Committee business and floor voting this week.

The Wall Street Journal adds

Lawmakers return to work this week with a to-do list that includes passing a critical government-funding bill, solidifying access to same-sex marriage and setting priorities for the U.S. military before the start of the new Congress next year.

Other issues emphasized by Democrats, including passing a ban on the sale of assault-style weapons, are a long-shot given their narrow majority in the Senate. Most legislation requires 60 votes to advance in the Senate. In addition, lawmakers are discussing raising the federal debt ceiling, which limits how much the government can borrow.

Congress faces a Dec. 16 deadline to pass legislation that would continue funding the federal government; failure to do so could result in a partial shutdown. Lawmakers must decide whether to approve a short-term bill or reach a deal on more-detailed legislation that would fund the government for the full fiscal year.

The Senate also will be considering the National Defense Authorization Act, which typically includes government procurement law changes.

Tomorrow, the Federal Employee Benefits Open Season will reach its clubhouse turn with two weeks left to go. Although not a part of the Open Season, Federal News Network reports an important development concerning the Federal Employees Long Term Care Insurance Program (FLTCIP.

Those looking to enroll in the FLTCIP will soon have to wait a couple of years before applying.

The Office of Personnel Management said it will suspend all new applications to the program starting on Dec. 19. The suspension will last for the next two years, but those who apply ahead of the start date may still see their applications go through. During that time, current FLTCIP enrollees cannot apply to increase their coverage. The suspension will otherwise not affect the coverage of current enrollees.

* * *

The contract for the insurance program, with John Hancock Life and Health Insurance Company, typically lasts seven years before getting a renewal. The program normally gets a premium hike each time the contract turns over. During the open period for new contract proposals earlier this year, only the current underwriter John Hancock submitted a bid. The current FLTCIP contract will expire on April 30, 2023.

The upcoming suspension on applications will allow OPM “to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency said in a Nov. 18 notice. OPM added that it will only suspend applications when it is in the best interest of the program.

Many are eligible to apply for FLTCIP coverage, including federal employees, U.S. Postal Service employees and annuitants, as well as active and retired members of the uniformed services, and qualified relatives of feds. John Hancock has historically sponsored the program, and Long Term Care Partners, LLC, has administered it.

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

Reporting a positive or negative test result just became easier through a new website from the National Institutes of Health. MakeMyTestCount.org, developed through NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, allows users to anonymously report the results of any brand of at-home COVID-19 test.

COVID-19 testing remains an essential tool as the United States heads into the holiday season and people navigate respiratory viruses. While taking a rapid COVID-19 test has become commonplace, test results are not often reported. COVID-19 test results provide valuable data that public health departments can use to assess the needs and modify the responses in the local community, the state or the nation.

Lab tests have a well-established technology system for sharing test results. RADx Tech has been working on a system to standardize test reporting for at-home tests in a secure manner. The MakeMyTestCount.org website is built on this system for logging test results.

The Wall Street Journal tells us

U.S. life insurers paid a record $100 billion in 2021 in death benefits, fueled by another year of Covid-19 deaths, an industry trade group said.

Payouts rose 11% in 2021 to $100.19 billion, most likely due to the pandemic, according to the American Council of Life Insurers. The increase was on the heels of a 15% year-over-year rise in 2020, when death-benefit payments totaled $90.43 billion.

The ACLI compiles data from annual filings by insurers to state insurance departments. Given limitations in the filings, the group can’t break down causes of death, but it is reasonable to attribute the bulk of the increases to the pandemic, said Andrew Melnyk, ACLI vice president of research and chief economist.

The year-over-year increases are among the largest since the 1918 flu pandemic, when payments surged 41%. They are far above the 4.9% average from 2011 to 2021, the ACLI said.

From the No Surprises Act front, Healthcare Dive reports

House lawmakers expressed their discontent with a final rule on surprise billing and urged federal regulators to make changes.

House Ways and Means Committee Chairman Richard Neal, D-Ma., and ranking member Kevin Brady, R-Texas, sent a letter to HHS Secretary Xavier Becerra and other department heads again expressing disappointment with a much-contested section of the surprise billing ban.

The lawmakers “are severely disappointed to find that the August 2022 final rule violates the No Surprises Act in the same ways as before,” Neal and Brady said in a letter last week.

For Heaven’s sake, Congress should give the revised rule a chance before joining the medical associations in condemning it.

From the public health front, Health Payer Intelligence tells us

The number of Americans with a usual source of care has dropped 10 percent in the last 18 years, with only about three-quarters of people saying they have a regular primary care provider or at least a facility where they know they can access care, according to the Primary Care Collaborative (PCC) and AAFP Graham Center.

The analysis also revealed some health disparities, with folks who are Hispanic, have less than a high school education, are uninsured, and are younger being less likely to have a usual source of care than their counterparts. * * *

“Employers have a very important role to play to ensure that all their employees and their families have ready, convenient access to a usual source of affordable primary care,” said Asaf Bitton, MD, the executive director of Ariadne Labs – Harvard T.H. Chan School of Public Health.

“We applaud those employers who are providing highly accessible virtual and in-person primary care options, and working with preferred provider organizations and health systems to support patients in establishing and maintaining these crucial primary care relationships.”

Amen to that sentiment.

STAT New reports

Cardiovascular disease is responsible for about one in five deaths in women in the U.S., more than any other cause — including all forms of cancer combined. Black women like Shields are particularly vulnerable: In the U.S., Black adults are substantially more likely to die from heart disease than their white, Hispanic, or Asian or Pacific Islander counterparts.

To try to reduce deaths from heart disease, health professionals typically use basic risk calculators, which take about a dozen standard data points to predict a person’s likelihood of having a major event, such as a heart attack or stroke, in the next 10 years.

Regardless of their other risk factors, for the most part, patients who are young and female have a very low chance of having a cardiovascular event in the next 10 years, so they are unlikely to get recommendations for serious lifestyle interventions or medication. But they may still be heading down a path to a fatal event later in life.

Some 10 to 15% of pregnancies have at least one complication that is linked to later heart disease. In addition to preeclampsia, these include other forms of gestational hypertensiongestational diabetespreterm deliverylow birth weight; and placental abruption. People who experience miscarriages and stillbirths are also at greater risk of heart disease. Additional reproductive health conditions — including the early arrival of periods, polycystic ovary syndrome, infertility, and early menopause — have also been linked to increased risk.

These data, however, are all missing from standard cardiovascular disease risk calculators. Some pregnancy complications are listed as part of the comprehensive American Heart Association screening guidelines. But a large national 2014 survey revealed that only 16% of primary care physicians and 22% of cardiologists were using these full guidelines. The failure of health-care providers to screen for these sorts of early warning signs is in keeping with the long-standing pattern in which women’s risk for heart disease is chronically underestimated by medical professionals — as well as by women themselves.

That’s a big bowl of wrong.

From the plan design front, Beckers Payer Issues relates

Providers using EHRs that aren’t enabled for electronic prior authorization and the cost to upgrade to those EHRs are the main barriers preventing automated PA, according to a Nov. 14 America’s Health Insurance Plans survey

The health insurance trade group conducted an industrywide survey on “prior authorization practices and gold carding experience of commercial plans” between February and April, according to the report. AHIP received responses from 26 plans, covering a total of 122 million commercial enrollees.

Top barriers to automated prior authorization:

  1. Provider does not use EHR enabled for electronic PA: 71 percent
  2. Costly/burdensome for providers to buy/upgrade EHR for electronic PA: 71 percent
  3. Lack of interoperability between EHR vendors: 62 percent
  4. Costly for payers to enable PA rules and information to be delivered electronically: 43 percent
  5. Lack of electronic PA solutions on market: 19 percent

This is a surprising outcome considering how vociferously providers object to prior authorization.

Friday Items

Photo by Sincerely Media on Unsplash

The FEHBlog apologizes for the fact that his Grammarly program made a hash out of yesterday’s Miscellany post. The FEHBlog discovered and fixed the problems this afternoon if anyone cares to go back to read that post. Lo siento.

Going forward, the FEHBlog will be posting Covid stats on the first Friday of the month. Here is the CDC’s weekly interpretation of its Covid statistics which focuses on a CDC report on Covid mortality dated November 16, 2022, and summarized below:

The Wall Street Journal adds

Uptake of fall Covid-19 booster shots remains anemic well into November, frustrating public-health experts who blame the lackluster interest on pandemic fatigue and insufficient outreach from officials.

About 31 million people in the U.S. have gotten the updated shots, or roughly 10% of people ages five and older, according to data from the Centers for Disease Control and Prevention. The federal government purchased more than 170 million doses of the new bivalent boosters that target two Omicron subvariants and the original virus strain.

“It has been pretty dismal,” said Rupali Limaye, an associate professor at the Johns Hopkins Bloomberg School of Public Health, who studies vaccine demand and acceptance. * * *

[U]ptake of the modified booster is slow due in part to the limited amount of outreach and type of messaging from health officials, some public-health experts say.

Anecdotally, it sounds like a lot of people are still not aware that the bivalent boosters are available,” said Angela Rasmussen, a virologist at Georgetown University. “If they are, many don’t seem to understand the importance of getting boosted at all—with bivalent or original recipe—and there is a decided lack of urgency in communications about it.” 

Some public-health experts say there must be not just more, but also targeted outreach. Celine Gounder, a senior fellow at the Kaiser Family Foundation, said messaging needs to be more targeted at people age 50 and over who are most at risk. Among adults 65 and older, some 27% have gotten an updated booster dose, CDC data show. 

“You should be thinking of who is most vulnerable and target the efforts there,” said Dr. Gounder, an infectious-disease specialist and epidemiologist.

The following are the key points from this week’s CDC Fluview:

  • Seasonal influenza activity is elevated across the country.
  • The majority of influenza viruses detected this season have been influenza A(H3N2) viruses, but the proportion of subtyped influenza A viruses that are A(H1N1) is increasing slightly.
  • Two more influenza-associated pediatric deaths were reported this week, for a total of seven pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 4.4 million illnesses, 38,000 hospitalizations, and 2,100 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 45 during every previous season since 2010-2011.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

Medscape offers expert opinions on the “perfect storm” of rampant flu and RSV.

In OPM news, the agency posted its Fiscal Year 2022 Performance and Accountability report this week. The Director’s response to the Inspector General’s list of top management challenges is worth a gander. That response begins on page 125.

From the No Surprises Act front, Beckers Payer Issues tells us

The No Surprises Act has prevented millions of surprise medical bills since January, according to new data from AHIP and the Blue Cross Blue Shield Association. 

The payer associations gathered their data, published Nov. 17, by surveying 84 health insurance providers representing around 57 percent of the national market. 

“Thanks to the No Surprises Act, millions of Americans no longer face a complicated, confusing billing bureaucracy, being harassed by collection agencies, or even potential legal action,” AHIP President Matt Eyles said in a press release. 

AHIP and the BCBS Association also surveyed plans for the number of claims submitted to arbitration under the act. They estimated 275,000 claims have been submitted since January 2022, more than the 17,000 claims predicted by government agencies. 

and

AHIP is backing HHS in a lawsuit over surprise billing arbitration from Texas providers, who have support from the largest associations of providers. 

The trade association filed an amicus brief in Texas Medical Association v. HHS on Nov. 16. 

The lawsuit, filed by the Texas Medical Association in September, challenges the arbitration process established under the No Surprises Act. 

The FEHBlog appreciates AHIP’s amicus brief filing. In the FEHBlog’s opinion, the medical association plaintiffs in the Texas case are making a mountain out of a molehill.

A surprising legal development was the Justice Department’s 11th hour notice of appeal filed today in the antitrust challenge to United Healthcare’s acquisition of Change Healthcare which a federal district judge approved last September.

In other Friday items —

Endpoints reports

The emergence of interchangeable biosimilars since the pathway opened up has been slow. But the FDA on Thursday approved the fourth interchangeable biosimilar, which is also the second interchangeable biosimilar insulin product.

Eli Lilly’s Rezvoglar (insulin glargine-aglr), which converted to an interchangeable after an earlier biosimilar approval in December 2021, follows Viatris’ Semglee in seeking out a niche to compete with Sanofi’s blockbuster Lantus (insulin glargine). * * *

These interchangeable designations mean Semglee and Rezvoglar may be substituted at the pharmacy level for Lantus, without a doctor’s prescription, and as long as the state pharmacy law permits the switch.

USA Today reports

Preterm births last year reached their highest peak since 2007 – with more than 383,000 born before 37 weeks of gestational age in the United States, according to a new report.

In 2021, roughly 10.5% of U.S. babies were born premature, according to the annual March of Dimes “Report Card,” which rated the United States at D+. The score dropped from its C- rating in 2020, when the preterm birth rate saw its first decline in six years, a slight decrease to 10.1%.

The report released this week found disparities widened between white mothers and Native and Black mothers, who are already 62% more likely to have a preterm birth and nearly three times as likely as white moms to die of childbirth-related causes. In 2021, Black mothers saw a 3% increase and Native mothers a 6% increase in preterm births, according to the analysis.

Of all groups, Asian and Pacific Islander mothers saw the largest preterm birth increase – an 8% surge  – even though births to Asian mothers decreased that year, and they have the lowest preterm birth rate overall.

HHS’s Agency for Healthcare Quality and Research capped off antibiotic awareness week by releasing antibiotic stewardship kits for the acute hospital, long-term care, and ambulatory care settings.

Midweek update

From Capitol Hill, the Wall Street Journal reports

Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.

The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.

Healthcare Dive adds

With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.

“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,

Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.

Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.

In other HLTH 2022 conference news,

  • Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
  • MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”

From the federal employee benefits front,

  • Govexec collected all of its current Open Season articles for convenient access.
  • Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
  • Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.

From the Affordable Care Act front —

  • The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
  • The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”

From the public health front —

  • Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
  • CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
  • The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”

From the miscellany department —

  • Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
  • MedTech Dive discusses how Labcorp, Abbott, BD, and Siemens plan to expand the home testing market
  • NCQA looks back at its recent Health Innovation Summit.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Federal Employees Benefit Open Season front —

  • My Federal Retirement discusses the availability of high deductible plans coupled with health savings accounts in the FEHB.
  • A Federal Times expert, Reg Jones, explains the differences between Open Season and special enrollment periods.

In related news, Federal News Network tells us

Over 200 members of the Senior Executive Service this year will receive Presidential Rank Awards, considered the highest honor for career civil servants.

President Joe Biden picked 233 winners across a total of 33 different agencies for the 2022 awards program, the Office of Personnel Management announced on Nov. 15.

“Each and every day, our federal employees are working to address the nation’s most pressing issues, developing technologies to improve millions of lives, and ultimately, achieving the seemingly unachievable on behalf of the American public,” OPM Director Kiran Ahuja said in a press statement. “This year’s Presidential Rank Awards reflect the Biden-Harris administration’s support for hardworking civil servants who exemplify strength, integrity, industry and a relentless commitment to public service through their exceptional leadership, contributions and accomplishments.”

Kudos to the winners.

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

Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers.

Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.

“That really bodes well for the vaccine and public health,” Moderna President Stephen Hoge said in an interview.

From the conferences’ front —

  • The American Medical Association explains what happened on the closing day of the AMA’s interim meeting.
  • Healthcare Dive offers Dive Briefs from the HLTH conference about Included Health and Elevance Health. Fierce Healthcare adds “Mental health provider SonderMind acquired neuroscience company Total Brain with the goal of revolutionizing personalized therapeutic care and providing individual insights into mental wellbeing.”

In other U.S. Healthcare business news

Healthcare Dive informs us

  • “Amazon has launched a message-based virtual health service called Amazon Clinic a little more than two months after the retail giant shuttered its primary care delivery business Amazon Care.
  • “Amazon Clinic, which is currently live and available 24/7 through Amazon’s website and mobile app, is a marketplace for telemedicine providers, connecting consumers with virtual doctors who can diagnose, treat and prescribe medication for a range of common health conditions like acne, birth control and migraines, the retail giant said.
  • “Amazon Clinic will be available in 32 states at launch, with plans to expand to additional states in the coming months, according to a Tuesday blog post announcing the news. * * *
  • “Consultation cost will vary by provider, including follow-up messages with a clinician for up to two weeks after the consultation. Consultations start at $30.
  • “Amazon Clinic does not accept insurance. The company didn’t disclose whether that would change in the future.”

Minnesota Public Radio tells us

Nearly a decade after unsuccessfully attempting a merger, South Dakota-based Sanford Health and Minnesota’s Fairview Health Services said Tuesday they’re again in talks to combine.

The two regional health care giants say they intend to complete a merger next year. The new entity would be called Sanford Health and be run by Sanford’s current CEO. The deal would include the University of Minnesota hospitals, which Fairview purchased in 1997.

Financial details and any cost-cutting plans tied to the proposed merger were not immediately disclosed.

From the Food and Drug Administration front —

On Thursday [November 10], the FDA, in conjunction with the CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey. Findings show that in 2022, more than one in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days – including 16.5% of high school and 4.5% of middle school students. The full results are available here

Today, the FDA announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad. 

Also [t]oday, the FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

From the No Surprises Act front, today was the deadline for the public to submit comments to the NSA regulators concerning two unnecessarily complicated consumer protections found in the law — the good faith estimate and the advance explanation of benefits. In the FEHBlog’s view, the NSA regulators would be well served if they limited those protections to surprise billing situations not elsewhere covered by the law, for example, (1) complicated procedures and (2) reoccurring services that take place over a prolonged period, e.g. chiropractor care, mental health care. The WEDI group, which is an advisor to the HHS Secretary, also offers useful comments on the matter.

From the Affordable Care Act front, the U.S. Preventive Services Task Force gave an inconclusive (I) grade today to screening for obstructive sleep apnea in adults. “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea in the general adult population.” The USPSTF previously graded the apnea screening service an I grade in January 2017.

In closing, here’s a tidbit from the Wall Street Journal

The Earth is now home to eight billion people, the United Nations said, because people are living longer and fertility rates have surged in some countries. * * *

There were about 300 million people on Earth two millennia ago, according to the U.N. The population fluctuated in the centuries after that, largely because of plagues and natural disasters. Then the population accelerated, reaching one billion in 1804, four billion in 1974 and seven billion in 2011. * * *

Demographers project the world will reach its next population milestone—nine billion—around 2037.

The U.N. predicts that the global population will peak at around 10.4 billion during the 2080s and remain near that level until the start of the next century. Another forecast, from the Wittgenstein Centre for Demography and Global Human Capital at the University of Vienna, has it peaking at 9.67 billion in 2070, before a slow decline as fertility rates drop.

Midweek update

Photo by Tomasz Filipek on Unsplash

From the Omicron and siblings front —

Novovax announced that

the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

Reuters adds

Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.

Omicron-tailored shots by Pfizer Inc  and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.

The New York Times provides an update on the new Omicron variants, including this critical point

Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.

Health Payer Intelligence reports

Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.

The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.

Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.

From the U.S. healthcare business front —

Fierce Healthcare tells us

Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds. 

Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff. 

“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report. 

and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.

In the regard

  • A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
  • STAT News reports on another SDOH study

When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.

Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”

One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.

  • The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.

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

As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.

“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.

Job losses spurred by a recession could cut into commercial enrollment for insurers who generate revenue from selling health coverage to employers of all sizes. About half of the U.S. population relies on employer-based insurance for coverage.

Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.

Becker’s Payer Issues tells us

Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.

As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13. 

Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.

Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.

“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”

The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.

STAT News reports

A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.

Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.

The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.

From the Rx coverage front —

STAT News informs us

After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.

The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.

The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.

The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”

The FDA Commissioner, Robert Califf, MD, is the final decision maker.

The NCQA has created

A new website adds two key resources in the fight against antibiotic resistance:

* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.

* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.

From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.

Monday Roundup

Photo by Sven Read on Unsplash

From the FEHB Open Season front, OPM issued today its annual open season benefits administration letter identifying FEHB and FEDVIP contract changes for 2023 A/K/A, the Significant Changes letter and appendix. OPM also released its Federal Benefits Fast Facts for the upcoming Open Season.

The Federal Times offers an Open Season overview.

From the No Surprises Act front, Newfront, an insurance brokerage, issued an important reminder on the revised NSA consumer notice that health plans must post by January 1, 2023. Here are the current and future notices.

From the Covid vaccine mandate front, the Miller & Chevalier law firm tells us

On October 14, 2022, the Safer Federal Workforce Task Force released a roadmap for federal contractors of anticipated guidance on how federal agencies would be handling the implementation and enforcement of the federal contractor vaccine mandate and workplace safety requirements of Executive Order 14042, “Ensuring Adequate Safety Protocols for Federal Contractors.”  The Task Force — created by President Biden to provide guidance to federal agencies on handling operational issues related to the COVID-19 pandemic — anticipates a “potential narrowing of the existing nationwide injunction on October 18, 2022.” As a result, the Task Force anticipates the release of three documents: (1) notice from the Office of Management and Budget (OMB) to federal agencies regarding compliance with injunctions and the inclusion of vaccine mandate clauses in future solicitations and contracts; (2) updates to Task Force guidance on safety protocols for covered contractor and subcontractor workplace locations, including a timeline for implementation; and (3) additional guidance from OMB on “timing and considerations for provision of written notice from agencies to contractors regarding enforcement of contract clauses” implementing vaccine and workplace safety mandates. Notably, until OMB issues the guidance above, agencies are directed not to take any steps to require compliance with the Task Force guidance or enforce any contract clauses implementing the requirements of Executive Order 14042.

This Task Force guidance stems from an August 26, 2022, U.S. Court of Appeals for the 11th Circuit opinion replacing the lower court’s nationwide injunction with an injunction applying to the plaintiffs. However, several other U.S. Courts of Appeals are hearing cases involving this mandate so we may be waiting a while for the OMB guidance.

Also, from the Omicron and siblings front, Beckers Hospital Review discusses the new Omicron variants BQ.1 and BQ1.1.

CDC estimates indicate a new omicron variant, BQ.1, and its descendent BQ.1.1 account for 11.4 percent of cases nationwide. The pair have been dubbed “escape variants” for their ability to escape immunity and are currently most prevalent in New York and New Jersey, where they account for nearly 20 percent of new infections. * * *

Experts are optimistic that the bivalent omicron boosters will offer protection against BQ.1 and BQ.1.1 since they’re descendants of BA.5. (Updated boosters are designed to target the original SARS-CoV-2 strain, BA.4 and BA.5.)

“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sublineage, so there are almost certainly going to be some cross protection that you can boost up,” Dr. Fauci said. 

From the monkeypox front, the American Hospital Association reports

The Centers for Disease Control and Prevention today reported the first U.S. monkeypox case in a health care worker since the outbreak began in May. The report describes how an emergency department nurse in Florida was exposed to the virus through a needlestick, and recommends approaches to preventing infections in health care workers. CDC also released a report describing five patients who acquired ocular monkeypox, a rare but sight-threatening condition, including four who were hospitalized. The report recommends health care providers advise monkeypox patients to practice hand hygiene and avoid touching their eyes, and consider urgent ophthalmologic evaluation and monkeypox-directed treatment for patients with ocular signs and symptoms.

From the influenza front —

Beckers Hospital Review relates

The U.S. is seeing flu activity rise earlier than usual, with Southern states reporting the highest levels of activity, according to the CDC’s latest FluView report for the week ending Oct. 8. 

Overall, activity remains low, “but increasing in most of the country,” the CDC said. HHS region 4 (Kentucky, Tennessee, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Florida) and region 6 (New Mexico, Texas, Oklahoma, Arkansas, Louisiana) are reporting the highest levels of flu activity. 

Furthermore, STAT News “talked on Friday with Lynnette Brammer, a flu epidemiologist and team lead for domestic surveillance in the CDC’s influenza division, to get a sense of what the agency is seeing.”

Thinking about this flu season and what you’re seeing so far, what’s your best guess for what’s ahead?

Our syndromic surveillance methods are much trickier to try and interpret now, with Covid in the picture. It just muddies the water, basically.

We’ll have to see if the flu and Covid circulate at the same time. Right now, it looks like Covid is still trending down in a lot of the country, but flu’s going up in a lot of the country.

If individuals start to feel crappy this winter, how will they know if it’s a cold? Flu? Covid?

I think testing is going to be really important given that, for flu and Covid, there are treatments that — particularly for high-risk people — can make a huge difference in how well they are able to get through their illness. So it’s going to be really important to test so physicians can know the appropriate treatment for their patients.

In related news, the Government Accountability Office released a report on routine vaccination rates in our country.

U.S. school children generally have higher rates of vaccination to protect them from preventable illness compared with adults.

We found gaps in adult rates for flu, shingles, tetanus, and pneumococcal (prevents pneumonia and more) vaccines. Among other things:

Adults were about 40% more likely to get the tetanus and pneumococcal vaccines than the shingles vaccine

Vaccination rates for Black or African American and Hispanic or Latino adults were about 13% below that of White adults for each vaccine

Health and Human Services is using social media and its website to raise public awareness on the importance of being vaccinated.

From the ACA reporting front, the Internal Revenue Service issued its Forms 1095-B and 1095-C for 2022. The Service also released an employee fringe benefits guide for federal, state, and local government employers.

From the Rx coverage front, BioPharma Dive predicts “five questions facing drugmakers as third-quarter earnings begin. Alzheimer’s study results, drug pricing law, bring new questions for many of the industry’s top companies.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports

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

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

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

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

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

Today was filled with surprises.

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

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

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

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

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

From the benefit design front, Fierce Healthcare reports

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

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

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

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

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

From the studies/research department

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

From the tidbits department

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

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

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

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

 

Thursday Miscellany

Photo by Josh Mills on Unsplash

Yesterday, the FEHBlog welcomed the first day of autumn when the autumnal equinox was at 9:04 pm today. To compound his error, the FEHBlog overlooked that yesterday was World Gratitude Day. The FEHBlog is grateful for his readers.

From Capitol Hill, Roll Call reports on the state of the continuing resolution to fund the federal government into mid-December.

Congressional leaders and appropriators are expected to spend the weekend haggling over the last details of the text Schumer is aiming to unveil Tuesday [following the Jewish New Year holiday], which he would offer as a substitute amendment.

On Thursday, authorizing committees agreed on a five-year reauthorization of FDA user fee programs, which could potentially be attached to the continuing resolution. Numerous other authorizations, funding “anomalies” and a supplemental aid package for Ukraine and other purposes were still being negotiated. 

The House of Representatives is capable of acting quickly.

From the Omicron and siblings’ front

  • Beckers Hospital Review reports, “Retooled COVID-19 booster shots that target omicron subvariants could be authorized and available for children to receive within a month, the CDC said in a vaccination planning guide released Sept. 20.”

In other public health news, STAT News tells us

As some of us wonder how we’ll know when the coronavirus pandemic is over, a new report from the WHO called “Invisible Numbers” reminds us that noncommunicable diseases take more lives than infectious diseases (and make Covid-19 worse). To wit: Cardiovascular diseases including heart disease and stroke, cancer, diabetes, chronic respiratory diseases, and mental illness cause nearly three-quarters of deaths in the world and kill 41 million people every year. Some of the more striking findings:

* Every year 17 million people under age 70 die of noncommunicable diseases, 86% of whom live in low- or middle-income countries.

* Preventable risk factors include tobacco use, unhealthy diets, harmful use of alcohol, physical inactivity, and air pollution.

* NCDs cause 74% of all deaths, but interventions known to work could avert at least 39 million NCD deaths by 2030.

In that regard, ABC News reports

Cancer deaths in the United States are continuing to decline, according to a new report from the American Association for Cancer Research.

The report, published Wednesday, found that deaths from cancer have decreased by 2.3% every year between 2016 and 2019.

Overall, there has been a 32% reduction in the U.S. cancer death rate since 1991, which translates into approximately 3.5 million lives being saved, the report said.

Additionally, in 2022, there are more than 18 million cancer survivors living in the U.S., equivalent to 5.4% of the population, the report found. Fifty years earlier, there were just 3 million cancer survivors.

That’s remarkable.

In related medical research news,

Medscape reports

New results from a large prospective trial give a better idea of how a blood test that can detect multiple cancers performs in a “real-life” setting.

“As this technology develops, people must continue with their standard cancer screening, but this is a glimpse of what the future may hold,” commented study investigator Deborah Schrag, MD, MPH, chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City.

STAT News relates

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations.

Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places. If successful, they will help answer fundamental questions about the body’s most complex organ. What are all the cell types in the brain? How are they connected to one another? How do the workings of the brain change during disease, and what can we do about that?

So far, those questions have proven easier to ask than to answer, with researchers gleaning bits of information from individual studies, but the hope is that a broad-based effort will jump-start new revelations.

Hope springs eternal.

From the mental healthcare front —

Health Payer Intelligence explains

CVS Health is making progress toward its behavioral health goal of decreasing the suicide rate among Aetna members by 20 percent by 2025, but progress among adolescent members is lagging, the healthcare organization announced.

“Our members are not immune to the national suicide crisis reported by the CDC. Though we are on track lowering suicide attempts in adults, our goal will not be reached until we can say the same for adolescents,” said Sree Chaguturu, MD, executive vice president and chief medical officer at CVS Health.

The organization has been working toward this goal since 2017, its work running parallel to that of the American Foundation for Suicide Prevention (AFSP) which had the same goal.

As of March 2022, CVS Health saw suicide attempts among Aetna members drop by 15.7 percent when compared to the company’s 2019 rate.

CVS Health broke down the overall rate by age and found that the reductions were largely driven by decreases among members ages 18 and older. For individuals in this age range, suicide attempts dropped by 17.5 percent in 2021 and dropped another 34.1 percent through March 2022.

Having made progress toward the goal, however, the organization does not intend to slow down.

“We are doubling down on efforts to prevent suicide in teens by identifying those most at-risk and in need of intervention, reaching out to those discharged from the ER after a suicide attempt with resources and supporting parents and loved ones in prioritizing the mental health of their kids,” Chaguturu explained.

Specifically, Aetna saw an upward trend in suicide attempts among its adolescent members.

Members between the ages of 13 and 17 saw increases in suicide attempts. In 2021, the suicide rate among this population grew 43 percent. In the first three months of 2022, the suicide rate jumped another 32 percent.

“We are implementing evidence-based therapies and outreach programs to prevent suicidal ideation before it starts and get adolescents the clinical care they need when they are at risk,” said Cara McNulty, president of behavioral health and mental well-being at CVS Health. “Every suicide attempt prevented, life saved, and mental health resource sought is an important step to reducing death by suicide in the United States.”

Mazaal Tov to CVS Health for those successful and ongoing efforts.

The Society for Human Resources offers guidance on suicide prevention in the workplace.

From the No Surprises Act litigation front, STAT News explains

During a hearing yesterday, the Association of Air Medical Services indicated it was following in the footsteps of AHA and AMA and would likewise dismiss its claims now that the final rules are out. But the AAMS also said it was deliberating whether it would file a different lawsuit in a different court, while attorneys for AMA and AHA backpedaled and said they have no intentions of filing any new lawsuits anywhere.

Today we got some clarity when the Texas Medical Association filed a new lawsuit challenging the revised final independent dispute resolution rule issued in the summer. In addition, the American Hospital Association and the American Medical Association have announced that they are joining the case as friends of the court in support of the Texas Medical Association. The lawsuit was filed in the U.S. District Court for the Eastern District of Texas. And the beat goes on.

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

Humana Inc. HUM 0.67%▲ and CVS Health Corp. CVS 0.06%▲ are circling Cano Health Inc., CANO 32.17%▲ according to people familiar with the situation, as healthcare heavyweights scramble to snap up primary-care providers.

The talks are serious and a deal to purchase Cano could be struck in the next several weeks, assuming the negotiations don’t fall apart, some of the people said. Cano shares, which had been down nearly 7%, turned positive and closed up 32% after The Wall Street Journal reported on the talks with Humana and other unnamed parties, giving the company a market value of roughly $4 billion.

Bloomberg subsequently reported CVS’s interest.

It couldn’t be learned which other potential buyers might be in the mix, but Cano could be Humana’s to lose as the health insurer has a right of first refusal on any sale, part of an agreement that was originally struck in 2019.

Miami-based Cano operates primary-care centers in California, Florida, Nevada, New Mexico, Texas, Illinois, New York, New Jersey and Puerto Rico, according to documentation from the company. It mainly serves Medicare Advantage members, a private-sector alternative to Medicare for seniors.

Beckers Payer Issues tells us

Healthcare startup Curative, best-known for providing COVID-19 testing, is introducing a health plan with no copays or deductibles. 

The company is offering the new plan in the Austin, Texas, area, with plans to expand throughout Texas over the next year, Curative said Sept. 21. The announcement comes as the startup lays off 109 employees from its testing business in California.

In a news release, Fred Turner, co-founder and CEO of Curative, said the startup is on a mission to “drastically remake” the U.S. healthcare system. 

“The only way to achieve true cost transparency is for all in-network services to be covered at $0 cost, so members actually know where they stand and can get the care they need without surprise bills or medical debt,” Mr. Turner said in the release. 

According to the news release, Curative plan members will not owe any copay costs if they complete a baseline visit to evaluate preventive care and health literacy. 

From the Postal Service front, Federal News Network reports

Postmaster General Louis DeJoy announced Wednesday that all Executive and Administrative Schedule (EAS) and Pay Band Non-bargaining unit employees will soon receive a 3% salary increase, “regardless of their current salary maximum.”

DeJoy, in a memo to USPS officers Wednesday, said the pay increase will go into effect Sept. 24 and will reflect on the employees’ Oct. 14 pay statement.

Tuesday Tidbits

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.

Thursday Miscellany

From Capitol Hill, Healthcare Dive reports

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

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

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

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

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

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

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

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

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

To provide context, Beckers Hospital CFO Report informs us

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

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

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

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

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

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

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

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

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

From the healthcare technology front, Fierce Healthcare informs us

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

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

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

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

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